[House Prints 111-B]
[From the U.S. Government Publishing Office]




   111th Congress                                     Committee
     2nd Session            COMMITTEE PRINT          Print 111-B
_______________________________________________________________________



                  COMPILATION OF SELECTED ACTS WITHIN
                   THE JURISDICTION OF THE COMMITTEE
                         ON ENERGY AND COMMERCE

                               ----------                              

                               HEALTH LAW

                       Public Health Service Act
                   As Amended Through January 2, 2011

                               ----------                              

                      prepared for the use of the

                    COMMITTEE ON ENERGY AND COMMERCE

                     U.S. HOUSE OF REPRESENTATIVES








111th Congress                                                Committee
 2nd Session                COMMITTEE PRINT                 Print 111-B
_______________________________________________________________________

 
                  COMPILATION OF SELECTED ACTS WITHIN
                   THE JURISDICTION OF THE COMMITTEE
                         ON ENERGY AND COMMERCE

                               __________

                               HEALTH LAW

                       Public Health Service Act

                   As Amended Through January 2, 2011

                               __________

                      prepared for the use of the

                    COMMITTEE ON ENERGY AND COMMERCE

                     U.S. HOUSE OF REPRESENTATIVES









                  U.S. GOVERNMENT PRINTING OFFICE
  63-169                  WASHINGTON : 2011
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20402-0001







                    COMMITTEE ON ENERGY AND COMMERCE

                 HENRY A. WAXMAN, California, Chairman

JOHN D. DINGELL, Michigan            JOE BARTON, Texas
  Chairman Emeritus                    Ranking Member
EDWARD J. MARKEY, Massachusetts      RALPH M. HALL, Texas
RICK BOUCHER, Virginia               FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey       CLIFF STEARNS, Florida
BART GORDON, Tennessee               ED WHITFIELD, Kentucky
BOBBY L. RUSH, Illinois              JOHN SHIMKUS, Illinois
ANNA G. ESHOO, California            JOHN B. SHADEGG, Arizona
BART STUPAK, Michigan                ROY BLUNT, Missouri
ELIOT L. ENGEL, New York               Deputy Ranking Member
GENE GREEN, Texas                    STEVE BUYER, Indiana
DIANA DeGETTE, Colorado              GEORGE RADANOVICH, California
  Vice Chairman                      JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California               MARY BONO MACK, California
MIKE DOYLE, Pennsylvania             LEE TERRY, Nebraska
JANE HARMAN, California              MIKE ROGERS, Michigan
JAN SCHAKOWSKY, Illinois             SUE WILKINS MYRICK, North Carolina
CHARLES A. GONZALEZ, Texas           JOHN SULLIVAN, Oklahoma
JAY INSLEE, Washington               TIM MURPHY, Pennsylvania
TAMMY BALDWIN, Wisconsin             MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas                  MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York          PHIL GINGREY, Georgia
JIM MATHESON, Utah                   STEVE SCALISE, Louisiana
G.K. BUTTERFIELD, North Carolina     PARKER GRIFFITH, Alabama
CHARLIE MELANCON, Louisiana          ROBERT E. LATTA, Ohio
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin 
Islands
KATHY CASTOR, Florida
JOHN SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE BRALEY, Iowa
PETER WELCH, Vermont

                   Philip S. Barnett, Staff Director

                   Kristin L. Amerling, Chief Counsel

               David L. Cavicke, Minority Chief of Staff

                                  (ii)

  


    For changes after the closing date of this publication 
(January 2, 2011) to provisions of law in this publication, see 
the United States Code Classification Tables published by the 
Office of the Law Revision Counsel of the House of 
Representatives at 
http://uscode.house.gov/classification/tables.shtml.

                                 (iii)
               COMPILATION OF SELECTED ACTS -- HEALTH LAW
======================================================================


                       PUBLIC HEALTH SERVICE ACT

======================================================================


    NOTE.--Reorganization Plan No. 3 of 1966 transferred all 
statutory powers and functions of the Surgeon General and other 
officers of the Public Health Service and of all agencies of or 
in the Service to the Secretary of Health, Education, and 
Welfare. The Department of Education Organization Act 
designated the Secretary of Health, Education, and Welfare as 
the Secretary of Health and Human Services. References in the 
Act to the Surgeon General, other officers of the Service, the 
Secretary of Health, Education, and Welfare, and the Department 
of Health, Education, and Welfare, should be read in the light 
of the transfer of statutory functions and the redesignation.
START OF STATUTE deg.STATUTE NAME= deg.PUBLIC HEALTH 
                              SERVICE ACT

   [As Amended Through P.L. ___ (H.R. 847), Enacted January 2, 2011]

   (References in brackets [  ] are to title 42, United States Code)

                  TITLE I--SHORT TITLE AND DEFINITIONS

                              short title

    Section 1. [201 note] This Act may be cited as the ``Public 
Health Service Act''.

                              definitions

    Sec. 2. [201] When used in this Act--
    (a) The term ``Service'' means the Public Health Service;
    (b) The term ``Surgeon General'' means the Surgeon General 
of the Public Health Service;
    (c) Unless the context otherwise requires, the term 
``Secretary'' means the Secretary of Health and Human Services;
    (d) The term ``regulations'', except when otherwise 
specified, means rules and regulations made by the Surgeon 
General with the approval of the Secretary;
    (e) The term ``executive department'' means any executive 
department, agency, or independent establishment of the United 
States or any corporation wholly owned by the United States;
    (f) Except as provided in sections 314(g)(4)(B), 318(c)(1), 
331(h)(3), 335(5), 361(d), 701(9), 1002(c), 1401(13), 1531(1), 
and 1633(1), the term ``State'' includes, in addition to the 
several States, only the District of Columbia, Guam, the 
Commonwealth of Puerto Rico, the Northern Mariana Islands, the 
Virgin Islands, American Samoa, and the Trust Territory of the 
Pacific Islands.
    (g) The term ``possession'' includes, among other 
possessions, Puerto Rico and the Virgin Islands;
    (h) [Repealed.]
    (i) The term ``vessel'' includes every description of 
watercraft or other artificial contrivance used, or capable of 
being used, as a means of transportation on water, exclusive of 
aircraft and amphibious contrivances;
    (j) The term ``habit-forming narcotic drug'' or 
``narcotic'' means opium and coca leaves and the several 
alkaloids derived therefrom, the best known of these alkaloids 
being morphia, heroin, and codeine, obtained from opium, and 
cocaine derived from the coca plant; all compounds, salts, 
preparations, or other derivatives obtained either from the raw 
material or from the various alkaloids; Indian hemp and its 
various derivatives, compounds, and preparations, and peyote in 
its various forms; isonipecaine and its derivatives, compounds, 
salts and preparations; opiates (as defined in section 3228(f) 
of the Internal Revenue Code);
    (k) The term ``addict'' means any person who habitually 
uses any habit-forming narcotic drugs so as to endanger the 
public morals, health, safety, or welfare, or who is or has 
been so far addicted to the use of such habit-forming narcotic 
drugs as to have lost the power of self-control with reference 
to his addiction;
    (l) The term ``psychiatric disorders'' includes diseases of 
the nervous system which affect mental health;
    (m) The term ``State mental health authority'' means the 
State health authority, except that, in the case of any State 
in which there is a single State agency, other than the State 
health authority, charged with responsibility for administering 
the mental health program of the State, it means such other 
State agency;
    (n) The term ``heart diseases'' means diseases of the heart 
and circulation;
    (o) The term ``dental diseases and conditions'' means 
diseases and conditions affecting teeth and their supporting 
structures, and other related diseases of the mouth;
    (p) The term ``uniformed service'' means the Army, Navy, 
Air Force, Marine Corps, Coast Guard, Public Health Service, or 
Coast and Geodetic Survey; and
    (q) The term ``drug dependent person'' means a person who 
is using a controlled substance (as defined in section 102 of 
the Controlled Substances Act) and who is in a state of psychic 
or physical dependence, or both, arising from the use of that 
substance on a continuous basis. Drug dependence is 
characterized by behavioral and other responses which include a 
strong compulsion to take the substance on a continuous basis 
in order to experience its psychic effects or to avoid the 
discomfort caused by its absence.
         TITLE II--ADMINISTRATION AND MISCELLANEOUS PROVISIONS

                         Part A--Administration

                         public health service

    Sec. 201. [202] The Public Health Service in the Department 
of Health and Human Services shall be administered by the 
Assistant Secretary for Health under the supervision and 
direction of the Secretary.

                              organization

    Sec. 202. \1\ [203] The Service shall consist of (1) the 
Office of the Surgeon General, (2) the National Institutes of 
Health, (3) the Bureau of Medical Services, and (4) the Bureau 
of State Services, and the Agency for Health Care Policy and 
Research. \2\ The Secretary is authorized and directed to 
assign to the Office of the Secretary, to the National 
Institutes of Health, to the Bureau of Medical Services, and to 
the Bureau of State Services, respectively, the several 
functions of the Service, and to establish within them such 
divisions, sections and other units as he may find necessary; 
and from time to time, abolish, transfer, and consolidate 
divisions, sections, and other units and assign their functions 
and personnel in such manner as he may find necessary for 
efficient operation of the Service. No division shall be 
established, abolished, or transferred, and no divisions shall 
be consolidated, except with the approval of the Secretary. The 
National Institutes of Health shall be administered as a part 
of the field service. The Secretary may delegate to any officer 
or employee of the Service such of his powers and duties under 
this Act, except the making of regulations, as he may deem 
necessary or expedient.
---------------------------------------------------------------------------
    \1\ The organizational units specified in this section, other than 
the Agency for Health Care Policy and Research, were all abolished as 
statutory entities by Reorganization Plan No. 3 of 1966. Although the 
Reorganization Plan abolished the National Institutes of Health as an 
agency, it did not abolish the individual research institutes.
        In 1985, Public Law 99-158 added title IV of this Act, which 
provides that the National Institutes of Health is an agency of the 
Public Health Service. See section 401(a).
        Other laws have established additional agencies within the 
Service. Section 501(a) of this Act provides that the Substance Abuse 
and Mental Health Services Administration is an agency of the Service. 
Section 901(a) establishes the Agency for Healthcare Research and 
Quality within the Service (formerly designated as the Agency for 
Health Care Policy and Research).
        Although not established in this Act, the Centers for Disease 
Control and Prevention, the Health Resources and Services 
Administration, and the Agency for Toxic Substances and Disease 
Registry are agencies of the Service.
        The Food and Drug Administration is also an agency of the 
Service.
    \2\  So in law. See section 2008(g)(2) of Public Law 103-43 (107 
Stat. 212). The term ``the Agency'' probably should be preceded by 
``(5)'', and the ``and'' before ``(4)'' probably should be struck. 
Further, Public Law 106-129 redesignated the Agency for Health Care 
Policy and Research as the Agency for Healthcare Research and Quality 
(see 113 Stat. 1653).
---------------------------------------------------------------------------

SEC. 203. [204] COMMISSIONED CORPS AND READY RESERVE CORPS.

    (a) Establishment.--
            (1) In general.--There shall be in the Service a 
        commissioned Regular Corps and a Ready Reserve Corps 
        for service in time of national emergency.
            (2) Requirement.--All commissioned officers shall 
        be citizens of the United States and shall be appointed 
        without regard to the civil-service laws and 
        compensated without regard to the Classification Act of 
        1923, \1\ as amended.
---------------------------------------------------------------------------
    \1\ Civil service and classification laws are now codified to title 
5, United States Code.
---------------------------------------------------------------------------
            (3) Appointment.--Commissioned officers of the 
        Ready Reserve Corps shall be appointed by the President 
        and commissioned officers of the Regular Corps shall be 
        appointed by the President with the advice and consent 
        of the Senate.
            (4) Active duty.--Commissioned officers of the 
        Ready Reserve Corps shall at all times be subject to 
        call to active duty by the Surgeon General, including 
        active duty for the purpose of training.
            (5) Warrant officers.--Warrant officers may be 
        appointed to the Service for the purpose of providing 
        support to the health and delivery systems maintained 
        by the Service and any warrant officer appointed to the 
        Service shall be considered for purposes of this Act 
        and title 37, United States Code, to be a commissioned 
        officer within the Commissioned Corps of the Service.
    (b) Assimilating Reserve Corp Officers Into the Regular 
Corps.--Effective on the date of enactment of the Patient 
Protection and Affordable Care Act, all individuals classified 
as officers in the Reserve Corps under this section (as such 
section existed on the day before the date of enactment of such 
Act) and serving on active duty shall be deemed to be 
commissioned officers of the Regular Corps.
    (c) Purpose and Use of Ready Research.--
            (1) Purpose.--The purpose of the Ready Reserve 
        Corps is to fulfill the need to have additional 
        Commissioned Corps personnel available on short notice 
        (similar to the uniformed service's reserve program) to 
        assist regular Commissioned Corps personnel to meet 
        both routine public health and emergency response 
        missions.
            (2) Uses.--The Ready Reserve Corps shall--
                    (A) participate in routine training to meet 
                the general and specific needs of the 
                Commissioned Corps;
                    (B) be available and ready for involuntary 
                calls to active duty during national 
                emergencies and public health crises, similar 
                to the uniformed service reserve personnel;
                    (C) be available for backfilling critical 
                positions left vacant during deployment of 
                active duty Commissioned Corps members, as well 
                as for deployment to respond to public health 
                emergencies, both foreign and domestic; and
                    (D) be available for service assignment in 
                isolated, hardship, and medically underserved 
                communities (as defined in section 799B) to 
                improve access to health services.
    (d) Funding.--For the purpose of carrying out the duties 
and responsibilities of the Commissioned Corps under this 
section, there are authorized to be appropriated $5,000,000 for 
each of fiscal years 2010 through 2014 for recruitment and 
training and $12,500,000 for each of fiscal years 2010 through 
2014 for the Ready Reserve Corps.

SEC. 203A. [204A] DEPLOYMENT READINESS.

    (a) Readiness Requirements for Commissioned Corps 
Officers.--
            (1) In general.--The Secretary, with respect to 
        members of the following Corps components, shall 
        establish requirements, including training and medical 
        examinations, to ensure the readiness of such 
        components to respond to urgent or emergency public 
        health care needs that cannot otherwise be met at the 
        Federal, State, and local levels:
                    (A) Active duty Regular Corps.
                    (B) Active Reserves.
            (2) Annual assessment of members.--The Secretary 
        shall annually determine whether each member of the 
        Corps meets the applicable readiness requirements 
        established under paragraph (1).
            (3) Failure to meet requirements.--A member of the 
        Corps who fails to meet or maintain the readiness 
        requirements established under paragraph (1) or who 
        fails to comply with orders to respond to an urgent or 
        emergency public health care need shall, except as 
        provided in paragraph (4), in accordance with 
        procedures established by the Secretary, be subject to 
        disciplinary action as prescribed by the Secretary.
            (4) Waiver of requirements.--
                    (A) In general.--The Secretary may waive 
                one or more of the requirements established 
                under paragraph (1) for an individual who is 
                not able to meet such requirements because of--
                            (i) a disability;
                            (ii) a temporary medical condition; 
                        or
                            (iii) any other extraordinary 
                        limitation as determined by the 
                        Secretary.
                    (B) Regulations.--The Secretary shall 
                promulgate regulations under which a waiver 
                described in subparagraph (A) may be granted.
            (5) Urgent or emergency public health care need.--
        For purposes of this section and section 214, the term 
        ``urgent or emergency public health care need'' means a 
        health care need, as determined by the Secretary, 
        arising as the result of--
                    (A) a national emergency declared by the 
                President under the National Emergencies Act 
                (50 U.S.C. 1601 et seq.);
                    (B) an emergency or major disaster declared 
                by the President under the Robert T. Stafford 
                Disaster Relief and Emergency Assistance Act 
                (42 U.S.C. 5121 et seq.);
                    (C) a public health emergency declared by 
                the Secretary under section 319 of this Act; or
                    (D) any emergency that, in the judgment of 
                the Secretary, is appropriate for the 
                deployment of members of the Corps.
    (b) Corps Management for Deployment.--The Secretary shall--
            (1) organize members of the Corps into units for 
        rapid deployment by the Secretary to respond to urgent 
        or emergency public health care needs;
            (2) establish appropriate procedures for the 
        command and control of units or individual members of 
        the Corps that are deployed at the direction of the 
        President or the Secretary in response to an urgent or 
        emergency public health care need of national, State or 
        local significance;
            (3) ensure that members of the Corps are trained, 
        equipped and otherwise prepared to fulfill their public 
        health and emergency response roles; and
            (4) ensure that deployment planning takes into 
        account--
                    (A) any deployment exemptions that may be 
                granted by the Secretary based on the unique 
                requirements of an agency and an individual's 
                functional role in such agency; and
                    (B) the nature of the urgent or emergency 
                public health care need.
    (c) Deployment of Detailed or Assigned Officers.--For 
purposes of pay, allowances, and benefits of a Commissioned 
Corps officer who is detailed or assigned to a Federal entity, 
the deployment of such officer by the Secretary in response to 
an urgent or emergency public health care need shall be deemed 
to be an authorized activity of the Federal entity to which the 
officer is detailed or assigned.

                            surgeon general

    Sec. 204. [205] The Surgeon General shall be appointed from 
the Regular Corps for a four-year term by the President by and 
with the advice and consent of the Senate. The Surgeon General 
shall be appointed from individuals who (1) are members of the 
Regular Corps, and (2) have specialized training or significant 
experience in public health programs. Upon the expiration of 
such term, the Surgeon General, unless reappointed, shall 
revert to the grade and number in the Regular or Reserve Corps 
that he would have occupied had he not served as Surgeon 
General.

         deputy surgeon general and assistant surgeons general

    Sec. 205. [206] (a) The Surgeon General shall assign one 
commissioned officer from the Regular Corps to administer the 
Office of the Surgeon General, to act as Surgeon General during 
the absence or disability of the Surgeon General or in the 
event of a vacancy in that office, and to perform such other 
duties as the Surgeon General may prescribe, and while so 
assigned he shall have the title of Deputy Surgeon General.
    (b) The Surgeon General shall assign eight commissioned 
officers from the Regular Corps to be, respectively, the 
Director of the National Institutes of Health, the Chief of the 
Bureau of State Services, the Chief of the Bureau of Medical 
Services, the Chief Medical Officer of the United States Coast 
Guard, the Chief Dental Officer of the Service, the Chief Nurse 
Officer of the Service, the Chief Pharmacist Officer of the 
Service, and the Chief Sanitary Engineering Officer of the 
Service, and while so serving they shall each have the title of 
Assistant Surgeon General.
    (c)(1) The Surgeon General, with the approval of the 
Secretary, is authorized to create special temporary positions 
in the grade of Assistant Surgeons General when necessary for 
the proper staffing of the Service. The Surgeon General may 
assign officers of either the Regular Corps or the Reserve 
Corps to any such temporary position, and while so serving they 
shall each have the title of Assistant Surgeon General.
    (2) Except as provided in this paragraph, the number of 
special temporary positions created by the Surgeon General 
under paragraph (1) shall not on any day exceed 1 per centum of 
the highest number, during the ninety days preceding such day, 
of officers of the Regular Corps on active duty and officers of 
the Reserve Corps on active duty for more than thirty days. If 
on any day the number of such special temporary positions 
exceeds such 1 per centum limitations, for a period of not more 
than one year after such day, the number of such special 
temporary positions shall be reduced for purposes of complying 
with such 1 per centum limitation only by the resignation, 
retirement, death, or transfer to a position of a lower grade, 
of any officer holding any such temporary position.
    (d) The Surgeon General shall designate the Assistant 
Surgeon General who shall serve as Surgeon General in case of 
absence or disability, or vacancy in the offices, of both the 
Surgeon General and the Deputy Surgeon General.

          grades, ranks, and titles of the commissioned corps

    Sec. 206. [207] (a) The Surgeon General during the period 
of his appointment as such, shall be of the same grade as the 
Surgeon General of the army; the Deputy Surgeon General and the 
Chief Medical Officer of the United States Coast Guard, while 
assigned as such, shall have the grade corresponding with the 
grade of major general; and the Chief Dental Officer, while 
assigned as such, shall have the grade as is prescribed by law 
for the officer of the Dental Corps selected and appointed as 
Assistant Surgeon General of the Army. During the period of 
appointment to the position of Assistant Secretary for Health, 
a commissioned officer of the Public Health Service shall have 
the grade corresponding to the grade of General of the Army. 
Assistant Surgeons General, while assigned as such, shall have 
the grade corresponding with either the grade of brigadier 
general or the grade of major general, as may be determined by 
the Secretary after considering the importance of the duties to 
be performed: Provided, That the number of Assistant Surgeons 
General having a grade higher than that corresponding to the 
grade of brigadier general shall at no time exceed one-half of 
the number of positions created by subsection (b) of section 
205 or pursuant to subsection (c) of such section. The grades 
of commissioned officers of the Service shall correspond with 
grades of officers of the Army as follows:
            (1) Officers of the director grade--colonel;
            (2) Officers of the senior grade--lieutenant 
        colonel;
            (3) Officers of the full grade--major;
            (4) Officers of the senior assistant grade--
        captain;
            (5) Officers of the assistant grade--first 
        lieutenant;
            (6) Officers of the junior assistant grade--second 
        lieutenant;
            (7) Chief warrant officers of (W-4) grade--chief 
        warrant officer (W-4);
            (8) Chief warrant officers of (W-3) grade--chief 
        warrant officer (W-3);
            (9) Chief warrant officers of (W-2) grade--chief 
        warrant officer (W-2); and
            (10) Warrant officers of (W-1) grade--warrant 
        officer (W-1).
    (b) The titles of medical officers of the foregoing grades 
shall be respectively (1) medical director, (2) senior surgeon, 
(3) surgeon, (4) senior assistant surgeon, (5) assistant 
surgeon and (6) junior assistant surgeon.
    (c) The President is authorized to prescribe titles, 
appropriate to the several grades, for commissioned officers of 
the Service other than medical officers. All titles of the 
officers of the Reserve Corps shall have the suffix 
``Reserve''.
    (d) Within the total number of officers of the Regular 
Corps authorized by the appropriation Act or Acts for each 
fiscal year to be on active duty, the Secretary shall by 
regulation prescribe the maximum number of officers authorized 
to be in each of the grades from the warrant officer (W-1) 
grade to the director grade, inclusive. Such numbers shall be 
determined after considering the anticipated needs of the 
Service during the fiscal year, the funds available, the number 
of officers in each grade at the beginning of the fiscal year, 
and the anticipated appointments, the anticipated promotions 
based on years of service, and the anticipated retirements 
during the fiscal year. The number so determined for any grade 
for a fiscal year may not exceed the number limitation (if any) 
contained in the appropriation Act or Acts for such year. Such 
regulations for each fiscal year shall be prescribed as 
promptly as possible after the appropriation Act fixing the 
authorized strength of the corps for that year, and shall be 
subject to amendment only if such authorized strength or such 
number limitation is thereafter changed. The maxima established 
by such regulations shall not require (apart from action 
pursuant to other provisions of this Act) any officer to be 
separated from the Service or reduced in grade.
      (e) In computing the maximum number of commissioned 
officers of the Public Health Service authorized by law to hold 
a grade which corresponds to the grade of brigadier general or 
major general, there may be excluded from such computation not 
more than three officers who hold such a grade so long as such 
officers are assigned to duty and are serving in a policymaking 
position in the Department of Defense.
    (f) In computing the maximum number of commissioned 
officers of the Public Health Service authorized by law or 
administrative determination to serve on active duty, there may 
be excluded from such computation officers who are assigned to 
duty in the Department of Defense.
                        appointment of personnel
    Sec. 207. [209] (a)(1) Except as provided in subsections 
(b) and (e) of this section, original appointments to the 
Regular Corps may be made only in the warrant officer (W-1), 
chief warrant officer (W-2), chief warrant officer (W-3), chief 
warrant officer (W-4), junior assistant, assistant, and senior 
assistant grades and original appointments to a grade above 
junior assistant shall be made only after passage of an 
examination, given in accordance with regulations of the 
President, in one or more of the several branches of medicine, 
dentistry, hygiene, sanitary engineering, pharmacy, psychology, 
nursing, or related scientific specialties in the field of 
public health.
    (2) Original appointments to the Reserve Corps may be made 
to any grade up to and including the director grade but only 
after passage of an examination given in accordance with 
regulations of the President. Reserve commissions shall be for 
an indefinite period and may be terminated at any time, as the 
President may direct.
    (3) No individual who has attained the age of forty-four 
shall be appointed to the Regular Corps, or called to active 
duty in the Reserve Corps for a period in excess of one year, 
unless (A) he has had a number of years of active service (as 
defined in section 211(d)) equal to the number of years by 
which his age exceeds forty-four, or (B) the Surgeon General 
determines that he possesses exceptional qualifications, not 
readily available elsewhere in the Commissioned Corps of the 
Public Health Service, for the performance of special duties 
with the Service, or (C) in the case of an officer of the 
Reserve Corps, the Commissioned Corps of the Service has been 
declared by the President to be a military service.
    (b)(1) Not more than 10 per centum of the original 
appointments to the Regular Corps authorized to be made during 
any fiscal year may be made to grades above that of senior 
assistant, but no such appointment (other than an appointment 
under section 204) may be made to a grade above that of 
director. For the purpose of this subsection the number of 
original appointments authorized to be made during a fiscal 
year shall be (1) the excess of the number of officers of the 
Regular Corps authorized by the appropriation Act or Acts for 
such year over the number of officers on active duty in the 
Regular Corps on the first day of such year, plus (2) the 
number of such officers of the Regular Corps who, during such 
fiscal year, have been or will be retired upon attainment of 
age sixty-four or have for any other reason ceased to be on 
active duty. In determining the number of appointments 
authorized by this subsection an appointment shall be deemed to 
be made in the fiscal year in which the nomination is 
transmitted by the President to the Senate.
    (2) In addition to the number of original appointments to 
the Regular Corps authorized by paragraph (1) to be made to 
grades above that of senior assistant, original appointments 
authorized to be made to the Regular Corps in any year may be 
made to grades above that of senior assistant, but not above 
that of director, in the case of any individual who--
            (A)(i) was on active duty in the Regular Corps on 
        July 1, 1960, (ii) was on such active duty continuously 
        for not less than one year immediately prior to such 
        date, and (iii) applies for appointment to the Regular 
        Corps prior to July 1, 1962; or
            (B) does not come within clause (A)(i) and (ii) but 
        was on active duty in the Reserve Corps continuously 
        for not less than one year immediately prior to his 
        appointment to the Regular Corps and has not served on 
        active duty continuously for a period, occurring after 
        June 30, 1960, of more than three and one-half years 
        prior to applying for such appointment.
    (3) No person shall be appointed pursuant to this 
subsection unless he meets standards established in accordance 
with regulations of the President.
    (c) Commissions evidencing the appointment by the President 
of officers of the Regular or Reserve Corps shall be issued by 
the Secretary under the seal of the Department of Health, 
Education, and Welfare.
    (d)(1) For purposes of basic pay and for purposes of 
promotion, any person appointed under subsection (a) to the 
grade of senior assistant in the Regular Corps and any person 
appointed under subsection (b), shall, except as provided in 
paragraphs (2) and (3) of this subsection, be considered as 
having had on the date of appointment the following length of 
service: Three years if appointed to the senior assistant 
grade, ten years if appointed to the full grade, seventeen 
years if appointed to the senior grade, and eighteen years if 
appointed to the director grade.
    (2) For purposes of basic pay, any person appointed under 
subsection (a) to the grade of senior assistant in the Regular 
Corps, and any person appointed under subsection (b), shall, in 
lieu of the credit provided in paragraph (1), be credited with 
the service for which he is entitled to credit under any other 
provision of law if such service exceeds that to which he would 
be entitled under such paragraph.
    (3) For purposes of promotion, any person originally 
appointed in the Regular Corps to the senior assistant grade or 
above who has had active service in the Reserve Corps shall be 
considered as having had on the date of appointment the length 
of service provided for in paragraph (1), plus whichever of the 
following is greater: (A) The excess of his total active 
service in the Reserve Corps (above the grade of junior 
assistant) over the length of service provided in such 
paragraph, to the extent that such excess is on account of 
service in the Reserve Corps in or above the grade to which he 
is appointed in the Regular Corps or (B) his active service in 
the same or any higher grade in the Reserve Corps after the 
first day on which, under regulations in effect on the date of 
his appointment to the Regular Corps, he would have had the 
training and experience necessary for such appointment.
    (4) For purposes of promotion, any person whose original 
appointment is to the assistant grade in the Regular Corps 
shall be considered as having had on the date of appointment 
service equal to his total active service in the Reserve Corps 
in and above the assistant grade.
    (e)(1) A former officer of the Regular Corps may, if 
application for appointment is made within two years after the 
date of the termination of his prior commission in the Regular 
Corps, be reappointed to the Regular Corps without examination, 
except as the Surgeon General may otherwise prescribe, and 
without regard to the numerical limitations of subsection (b).
    (2) Reappointments pursuant to this subsection may be made 
to the permanent grade held by the former officer at the time 
of the termination of his prior commission, or to the next 
higher grade if such officer meets the eligibility requirements 
prescribed by regulation for original appointment to such 
higher grade. For purposes of pay, promotion, and seniority in 
grade, such reappointed officer shall receive the credits for 
service to which he would be entitled if such appointment were 
an original appointment, but in no event less than the credits 
he held at the time his prior commission was terminated, except 
that if such officer is reappointed to the next higher grade he 
shall receive no credit for seniority in grade.
    (3) No former officer shall be reappointed pursuant to this 
subsection unless he shall meet such standards as the Secretary 
may prescribe.
    (f) In accordance with regulations, special consultants may 
be employed to assist and advise in the operations of the 
Service. Such consultants may be appointed without regard to 
the civil-service laws and their compensation may be fixed 
without regard to the Classification Act of 1923, as amended. 
\1\
---------------------------------------------------------------------------
    \1\ See footnote for the second sentence of section 203.
---------------------------------------------------------------------------
    (g) In accordance with regulations, individual scientists, 
other than commissioned officers of the Service, may be 
designated by the Surgeon General to receive fellowships, 
appointed for duty with the Service without regard to the 
civil-service laws and compensated without regard to the 
Classification Act of 1923, as amended, \1\ may hold their 
fellowships under conditions prescribed therein, and may be 
assigned for studies or investigations either in this country 
or abroad during the terms of their fellowships.
    (h) Persons who are not citizens may be employed as 
consultants pursuant to subsection (e) and may be appointed to 
fellowships pursuant to subsection (f). Unless otherwise 
specifically provided, any prohibition in any other Act against 
the employment of aliens, or against the payment of 
compensation to them, shall not be applicable in the case of 
persons employed or appointed pursuant to such subsections.
    (i) The appointment of any officer or employee of the 
Service made in accordance with the civil-service laws shall be 
made by the Secretary, and may be made effective as of the date 
on which such officer or employee enters upon duty.
                           pay and allowances
    Sec. 208. [210] (a)(1) Commissioned officers of the Regular 
and Reserve Corps shall be entitled to receive such pay and 
allowances as are now or may hereafter be authorized by law.
    (2) For provisions relating to the receipt of special pay 
by commissioned officers of the Regular and Reserve Corps while 
on active duty, see section 303a(b) of title 37, United States 
Code.
    (b) Commissioned officers on active duty, and retired 
officers entitled to retired pay pursuant to section 210(g)(3), 
section 211 or section 221(a), shall be permitted to purchase 
supplies from the Army, Navy, Air Force, and Marine Corps at 
the same price as is charged officers thereof.
    (c) Members of the National Advisory Health Council and 
members of other national advisory or review councils or 
committees established under this Act, including members of the 
Technical Electronic Product Radiation Safety Standards 
Committee and the Board of Regents of the National Library of 
Medicine, but excluding ex officio members, while attending 
conferences or meetings of their respective councils or 
committees or while otherwise serving at the request of the 
Secretary shall be entitled to receive compensation at rates to 
be fixed by the Secretary, but at rates not exceeding the daily 
equivalent of the rate specified at the time of such service 
for grade GS-18 of the General Schedule, including traveltime; 
and while away from their homes or regular places of business 
they may be allowed travel expenses, including per diem in lieu 
of subsistence, as authorized by section 5703 of title 5 of the 
United States Code for persons in the Government service 
employed intermittently.
    (d) Field employees of the Service, except those employed 
on a per diem or fee basis, who render part-time duty and are 
also subject to call at any time for services not contemplated 
in their regular part-time employment, may be paid annual 
compensation for such part-time duty and, in addition, such 
fees for such other services as the Surgeon General may 
determine; but in no case shall the total paid to any such 
employee for any fiscal year exceed the amount of the minimum 
annual salary rate of the classification grade of the employee.
    (e) Any civilian employee of the Service who is employed at 
the Gillis W. Long Hansen's Disease Center on the date of the 
enactment of the Consolidated Omnibus Budget Reconciliation Act 
of 1985 shall be entitled to receive, in addition to any 
compensation to which the employee may otherwise be entitled 
and for so long as the employee remains employed at the Center, 
an amount equal to one-fourth of such compensation.
    (f) Individuals appointed under subsection (g) shall have 
included in their fellowships such stipends or allowances, 
including travel and subsistence expenses, as the Surgeon 
General may deem necessary to procure qualified fellows.
    (g) The Secretary is authorized to establish and fix the 
compensation for, within the Public Health Service, not more 
than one hundred and seventy-nine positions, of which not less 
than one hundred and fifteen shall be for the National 
Institutes of Health, not less than five shall be for the 
National Institute on Alcohol Abuse and Alcoholism for 
individuals engaged in research on alcohol and alcoholism, not 
less than ten shall be for the National Center for Health 
Services Research, not less than twelve shall be for the 
National Center for Health Statistics, and not less than seven 
shall be for the National Center for Health Care Technology, in 
the professional, scientific, and executive service, each such 
position being established to effectuate those research and 
development activities of the Public Health Service which 
require the services of specially qualified scientific, 
professional, and administrative personnel: Provided, That the 
rates of compensation for positions established pursuant to the 
provisions of this subsection shall not be less than the 
minimum rate of grade 16 of the General Schedule of the 
Classification Act of 1949, as amended, \1\ nor more than (1) 
the highest rate of grade 18 of the General Schedule of such 
Act, or (2) in the case of two such positions, the rate 
specified, at the time the service in the position is 
performed, for level II of the Executive Schedule (5 U.S.C. 
5313); and such rates of compensation for all positions 
included in this proviso shall be subject to the approval of 
the Civil Service Commission. Positions created pursuant to 
this subsection shall be included in the classified civil 
service of the United States, but appointments to such 
positions shall be made without competitive examination upon 
approval of the proposed appointee's qualifications by the 
Civil Service Commission or such officers or agents as it may 
designate for this purpose.
---------------------------------------------------------------------------
    \1\ See footnote for the second sentence of section 203.
---------------------------------------------------------------------------
                        professional categories
    Sec. 209. [210b] (a) For the purpose of establishing 
eligibility of officers of the Regular Corps for promotions, 
the Surgeon General shall by regulation divide the corps into 
professional categories. Each category shall, as far as 
practicable, be based upon one of the subjects of examination 
set forth in section 207(a)(1) or upon a subdivision of such 
subject, and the categories shall be designed to group officers 
by fields of training in such manner that officers in any one 
grade in any one category will be available for similar duty in 
the discharge of the several functions of the Service.
    (b) Each officer of the Regular Corps on active duty shall, 
on the basis of his training and experience, be assigned by the 
Surgeon General to one of the categories established by 
regulations under subsection (a). Except upon amendment of such 
regulations, no assignment so made shall be changed unless the 
Surgeon General finds (1) that the original assignment was 
erroneous, or (2) that the officer is equally well qualified to 
serve in another category to which he has requested to be 
transferred, and that such transfer is in the interests of the 
Service.
    (c) Within the limits fixed by the Secretary in regulations 
under section 206(d) for any fiscal year, the Surgeon General 
shall determine for each category in the Regular Corps the 
maximum number of officers authorized to be in each of the 
grades from the warrant officer (W-1) grade to the director 
grade, inclusive.
    (d) The excess of the number so fixed for any grade in any 
category over the number of officers of the Regular Corps on 
active duty in such grade in such category (including, in the 
case of the director grade, officers holding such grade in 
accordance with section 206(c)) shall for the purpose of 
promotions constitute vacancies in such grade in such category. 
For purposes of this subsection, an officer who has been 
temporarily promoted or who is temporarily holding the grade of 
director in accordance with section 206(c) shall be deemed to 
hold the grade to which so promoted or which he is temporarily 
holding; but while he holds such promotion or grade, and while 
any officer is temporarily assigned to a position pursuant to 
section 205(c), the number fixed under subsection (c) of this 
section for the grade of his permanent rank shall be reduced by 
one.
    (e) The absence of a vacancy in a grade in a category shall 
not prevent an appointment to such grade pursuant to section 
207, a permanent length of service promotion, or the recall of 
a retired officer to active duty; but the making of such an 
appointment, promotion, or recall shall be deemed to fill a 
vacancy if one exists.
    (f) Whenever a vacancy exists in any grade in a category 
the Surgeon General may increase by one the number fixed by him 
under subsection (c) for the next lower grade in the same 
category, without regard to the numbers fixed in regulations 
under section 206(d); and in that event the vacancy in the 
higher grade shall not be filled except by a permanent 
promotion, and upon the making of such promotion the number for 
the next lower grade shall be reduced by one.
promotions and separation of commissioned officers in the regular corps
    Sec. 210. [211] (a) Promotions of officers of the Regular 
Corps to any grade up to and including the director grade shall 
be either permanent promotions based on length of service, 
other permanent promotions to fill vacancies, or temporary 
promotions. Permanent promotions shall be made by the 
President, by and with the advice and consent of the Senate, 
and temporary promotions shall be made by the President. Each 
permanent promotion shall be to the next higher grade, and 
shall be made only after examination given in accordance with 
regulations of the President.
    (b) The President may by regulation provide that in a 
specified professional category permanent promotions to the 
senior grade, or to both the full grade and the senior grade, 
shall be made only if there are vacancies in such grade. A 
grade in any category with respect to which such regulations 
have been issued is referred to in this section as a 
``restricted grade''.
    (c) Examinations to determine qualification for permanent 
promotions may be either noncompetitive or competitive, as the 
Surgeon General shall in each case determine; except that 
examinations for promotions to the assistant or senior 
assistant grade shall in all cases be noncompetitive. The 
officers to be examined shall be selected by the Surgeon 
General from the professional category, and in the order of 
seniority in the grade, from which promotion is to be 
recommended. In the case of a competitive examination the 
Surgeon General shall determine in advance of the examination 
the number (which may be one or more) of officers who, after 
passing the examination, will be recommended to the President 
for promotion; but if the examination is one for promotions 
based on length of service, or is one for promotions to fill 
vacancies other than vacancies in the director grade or in a 
restricted grade, such number shall not be less than 80 per 
centum of the number of officers to be examined.
    (d) Officers of the Regular Corps, found pursuant to 
subsection (c) to be qualified, shall be given permanent 
promotions based on length of service, as follows:
    (1) Officers in the warrant officer (W-1) grade, chief 
warrant officer (W-2) grade, chief warrant officer (W-3) grade, 
chief warrant officer (W-4) grade, and junior assistant grade 
shall be promoted at such times as may be prescribed in 
regulations of the President.
    (2) Officers with permanent rank in the assistant grade, 
the senior assistant grade, and the full grade shall (except as 
provided in regulations under subsection (b)) be promoted after 
completion of three, ten, and seventeen years, respectively, of 
service in grades above the junior assistant grade; and such 
promotions, when made, shall be effective, for purposes of pay 
and seniority in grade, as of the day following the completion 
of such years of service. An officer with permanent rank in the 
assistant, senior assistant, or full grade who has not 
completed such years of service shall be promoted at the same 
time, and his promotion shall be effective as of the same day, 
as any officer junior to him in the same grade in the same 
professional category who is promoted under this paragraph.
    (e) Officers in a professional category of the Regular 
Corps, found pursuant to subsection (c) to be qualified may be 
given permanent promotions to fill any or all vacancies in such 
category in the senior assistant grade, the full grade, the 
senior grade, or the director grade; but no officer who has not 
had one year of service with permanent or temporary rank in the 
next lower grade shall be promoted to any restricted grade or 
to the director grade.
    (f) If an officer who has completed the years of service 
required for promotion to a grade under paragraph (2) of 
subsection (d) fails to receive such promotion, he shall 
(unless he has already been twice examined for promotion to 
such grade) be once reexamined for promotion to such grade. If 
he is thereupon promoted (otherwise than under subsection (e)), 
the effective date of such promotion shall be one year later 
than it would have been but for such failure. Upon the 
effective date of any permanent promotion of such officer to 
such grade, he shall be considered as having had only the 
length of service required for such promotion which he 
previously failed to receive.
    (g) If, for reasons other than physical disability, an 
officer of the Regular Corps in the warrant officer (W-1) grade 
or junior assistant grade is found pursuant to subsection (c) 
not to be qualified for promotion he shall be separated from 
the Service. If, for reasons other than physical disability, an 
officer of the Regular Corps in the chief warrant officer (W-
2), chief warrant officer (W-3), assistant, senior assistant, 
or full grade, after having been twice examined for promotion 
(other than promotion to a restricted grade), fails to be 
promoted--
            (1) if in the chief warrant officer (W-2) or 
        assistant grade he shall be separated from the Service 
        and paid six months' basic pay and allowances;
            (2) if in the chief warrant officer (W-3) or senior 
        assistant grade he shall be separated from the Service 
        and paid one year's basic pay and allowances;
            (3) if in the full grade he shall be considered as 
        not in line for promotion and shall, at such time 
        thereafter as the Surgeon General may determine, be 
        retired from the Service with retired pay (unless he is 
        entitled to a greater amount by reason of another 
        provision of law)--
                    (A) in the case of an officer who first 
                became a member of a uniformed service before 
                September 8, 1980, at the rate of 2\1/2\ 
                percent of the retired pay base determined 
                under section 1406(h) of title 10, United 
                States Code, for each year, not in excess of 
                30, of his active commissioned service in the 
                Service; or
                    (B) in the case of an officer who first 
                became a member of a uniformed service on or 
                after September 8, 1980, at the rate determined 
                by multiplying--
                            (i) the retired pay base determined 
                        under section 1407 of title 10, United 
                        States Code; by
                            (ii) the retired pay multiplier 
                        determined under section 1409 of such 
                        title for the number of years of his 
                        active commissioned service in the 
                        Service.
    (h) If an officer of the Regular Corps, eligible to take an 
examination for promotion, refuses to take such examination, he 
may be separated from the Service in accordance with 
regulations of the President.
    (i) At the end of his first three years of service, the 
record of each officer of the Regular Corps, originally 
appointed to the senior assistant grade or above, shall be 
reviewed in accordance with regulations of the President and, 
if found not qualified for further service, he shall be 
separated from the Service and paid six months' pay and 
allowances.
    (j)(1) The order of seniority of officers in a grade in the 
Regular Corps shall be determined, subject to the provisions of 
paragraph (2), by the relative length of time spent in active 
service after the effective date of each such officer's 
original appointment or permanent promotion in that grade. When 
permanent promotions of two or more officers to the same grade 
are effective on the same day, their relative seniority shall 
be the same as it was in the grade from which promoted. In all 
other cases of original appointments or permanent promotions 
(or both) to the same grade effective on the same day, relative 
seniority shall be determined in accordance with regulations of 
the President.
    (2) In the case of an officer originally appointed in the 
Regular Corps to the grade of assistant or above, his seniority 
in the grade to which appointed shall be determined after 
inclusion, as service in such grade, of any active service in 
such grade or in any higher grade in the Reserve Corps, but (if 
the appointment is to the grade of senior assistant or above) 
only to the extent of whichever of the following is greater: 
(A) His active service in such grade or any higher grade in the 
Reserve Corps after the first day on which, under regulations 
in effect on the date of his appointment to the Regular Corps, 
he had the training and experience necessary for such 
appointment, or (B) the excess of his total active service in 
the Reserve Corps (above the grade of junior assistant) over 
three years if his appointment in the Regular Corps is to the 
senior assistant grade, over ten years if the appointment is to 
the full grade, or over seventeen years if the appointment is 
to the senior grade.
    (k) Any commissioned officer of the Regular Corps in any 
grade in any professional category may be recommended to the 
President for temporary promotion to fill a vacancy in any 
higher grade in such category, up to and including the director 
grade. In time of war, or of national emergency proclaimed by 
the President, any commissioned officer of the Regular Corps in 
any grade in any professional category may be recommended to 
the President for promotion to any higher grade in such 
category, up to and including the director grade, whether or 
not a vacancy exists in such grade. The selection of officers 
to be recommended for temporary promotions shall be made in 
accordance with regulations of the President. Promotion of an 
officer recommended pursuant to this subsection may be made 
without regard to length of service, without examination, and 
without vacating his permanent appointment, and shall carry 
with it the pay and allowances of the grade to which promoted. 
Such promotions may be terminated at any time, as may be 
directed by the President.
    (l) Whenever the number of officers of the Regular Corps on 
active duty, plus the number of officers of the Reserve Corps 
who have been on active duty for thirty days or more, exceeds 
the authorized strength of the Regular Corps, the Secretary 
shall determine the requirements of the Service in each grade 
in each category, based upon the total number of officers so 
serving on active duty and the tasks being performed by the 
Service; and the Surgeon General shall thereupon assign each 
officer of the Reserve Corps on active duty to a professional 
category. If the Secretary finds that the number of officers 
fixed under section 209(c) for any grade and category (or the 
number of officers, including officers of the Reserve Corps, on 
active duty in such grade in such category, if such number is 
greater than the number fixed under section 209(c)) is 
insufficient to meet such requirements of the Service, officers 
of either the Regular Corps or the Reserve Corps may be 
recommended for temporary promotion to such grade in such 
category. Any such promotion may be terminated at any time, as 
may be directed by the President.
    (m) Any officer of the Regular Corps, or any officer of the 
Reserve Corps on active duty, who is promoted to a higher grade 
shall, unless he expressly declines such promotion, be deemed 
for all purposes to have accepted such promotion; and shall not 
be required to renew his oath of office, or to execute a new 
affidavit as required by the Act of December 11, 1926, as 
amended (5 U.S.C. 21a). \1\
---------------------------------------------------------------------------
    \1\ That Act has been codified to section 3332 of title 5, United 
States Code.
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                  retirement of commissioned officers
    Sec. 211. [212] (a)(1) A commissioned officer of the 
Service shall, if he applies for retirement, be retired on or 
after the first day of the month following the month in which 
he attains the age of sixty-four years. This paragraph does not 
permit or require the involuntary retirement of any individual 
because of the age of the individual.
    (2) A commissioned officer of the Service may be retired by 
the Secretary, and shall be retired if he applies for 
retirement, on the first day of any month after completion of 
thirty years of active service.
    (3) Any commissioned officer of the Service who has had 
less than thirty years of active service may be retired by the 
Secretary, with or without application by the officer, on the 
first day of any month after completion of twenty or more years 
of active service of which not less than ten are years of 
active commissioned service in any of the uniformed services.
    (4) Except as provided in paragraph (6), a commissioned 
officer retired pursuant to paragraph (1), (2), or (3) who was 
(in the case of an officer in the Reserve Corps) on active duty 
with the Service on the day preceding such retirement shall be 
entitled to receive retired pay at the rate of 2\1/2\ per 
centum of the basic pay of the highest grade held by him as 
such officer and in which, in the case of a temporary promotion 
to such grade, he has performed active duty for not less than 
six months, (A) for each year of active service, or (B) if it 
results in higher retired pay, for each of the following years:
            (i) his years of active service (determined without 
        regard to subsection (d)) as a member of a uniformed 
        service; plus
            (ii) in the case of a medical or dental officer, 
        four years and, in the case of a medical officer, who 
        has completed one year of medical internship or the 
        equivalent thereof, one additional year, the four years 
        and the one year to be reduced by the period of active 
        service performed during such officer's attendance at 
        medical school or dental school or during his medical 
        internship; plus
            (iii) the number of years of service with which he 
        was entitled to be credited for purposes of basic pay 
        on May 31, 1958, or (if higher) on any date prior 
        thereto, reduced by any such year included under clause 
        (i) and further reduced by any such year with which he 
        was entitled to be credited under paragraphs (7) and 
        (8) of section 205(a) of title 37, United States Code, 
        on any date before June 1, 1958;
except that (C) in the case of any officer whose retired pay, 
so computed, is less than 50 per centum of such basic pay, who 
retires pursuant to paragraph (1) of this subsection, who has 
not less than twelve whole years of active service (computed 
without the application of subsection (e)), and who does not 
use, for purposes of a retirement annuity under the Civil 
Service Retirement Act, \1\ any service which is also 
creditable in computing his retired pay from the Service, it 
shall, instead, be 50 per centum of such pay, and (D) the 
retired pay of an officer shall in no case be more than 75 per 
centum of such basic pay.
---------------------------------------------------------------------------
    \1\ The Civil Service Retirement Act has been codified to chapter 
83 of title 5, United States Code.
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    (5) With the approval of the President, a commissioned 
officer whose service as Surgeon General, Deputy Surgeon 
General, or Assistant Surgeon General has totaled four years or 
more and who has had not less than twenty-five years of active 
service in the Service may retire voluntarily at any time; and 
except as provided in paragraph (6), his retired pay shall be 
at the rate of 75 per centum of the basic pay of the highest 
grade held by him as such officer.
    (6) The retired pay of a commissioned officer retired under 
this subsection who first became a member of a uniformed 
service after September 7, 1980, is determined by multiplying--
            (A) the retired pay base determined under section 
        1407 of title 10, United States Code; by
            (B) the retired pay multiplier determined under 
        section 1409 of such title for the number of years of 
        service credited to the officer under paragraph (4).
    (7) Retired pay computed under section 210(g)(3) or under 
paragraph (4) or (5) of this subsection, if not a multiple of 
$1, shall be rounded to the next lower multiple of $1.
    (b) For purposes of subsection (a), the basic pay of the 
highest grade to which a commissioned officer has received a 
temporary promotion means the basic pay to which he would be 
entitled if serving on active duty in such grade on the date of 
his retirement.
    (c) A commissioned officer, retired for reasons other than 
for failure of promotion to the senior grade, may (1) if an 
officer of the Regular Corps or an officer of the Reserve Corps 
entitled to retired pay under subsection (a), be involuntarily 
recalled to active duty during such times as the Commissioned 
Corps constitutes a branch of the land or naval forces of the 
United States, and (2) if an officer of either the Regular or 
Reserve Corps, be recalled to active duty at any time with his 
consent.
    (d) The term ``active service'', as used in subsection (a), 
includes:
            (1) all active service in any of the uniformed 
        services;
            (2) active service with the Public Health Service, 
        other than as a commissioned officer, which the Surgeon 
        General determines is comparable to service performed 
        by commissioned officers of the Service, except that, 
        if there are more than five years of such service only 
        the last five years thereof may be included;
            (3) all active service (other than service included 
        under the preceding provisions of this subsection) 
        which is creditable for retirement purposes under laws 
        governing the retirement of members of any of the 
        uniformed services; and
            (4) service performed as a member of the Senior 
        Biomedical Research Service established by section 228, 
        except that, if there are more than 5 years of such 
        service, only the last 5 years thereof may be included.
    (e) For the purpose of determining the number of years by 
which a percentage of the basic pay of an officer is to be 
multiplied in computing the amount of his retired pay pursuant 
to section 210(g)(3) or paragraph (4) of subsection (a) of this 
section, each full month of service that is in addition to the 
number of full years of service credited to an officer is 
counted as one-twelfth of a year and any remaining fractional 
part of a month is disregarded.
    (f) For purposes of retirement or separation for physical 
disability under chapter 61 of title 10, United States Code, a 
commissioned officer of the Service shall be credited, in 
addition to the service described in section 1208(a)(2) of that 
title, with active service with the Public Health Service, 
other than as a commissioned officer, which the Surgeon General 
determines is comparable to service performed by commissioned 
officers of the Service, except that, if there are more than 
five years of such service, only the last five years thereof 
may be so credited. For such purposes, such section 1208(a)(2) 
shall be applicable to officers of the Regular or Reserve Corps 
of the Service.

                           military benefits

    Sec. 212. [213] (a) Except as provided in subsection (b), 
commissioned officers of the Service and their surviving 
beneficiaries shall, with respect to active service performed 
by such officers--
            (1) in time of war;
            (2) on detail for duty with the Army, Navy, Air 
        Force, Marine Corps, or Coast Guard; or
            (3) while the Service is part of the military 
        forces of the United States pursuant to Executive order 
        of the President;
be entitled to all rights, privileges, immunities, and benefits 
now or hereafter provided under any law of the United States in 
the case of commissioned officers of the Army or their 
surviving beneficiaries on account of active military service, 
except retired pay and uniform allowances.
    (b) The President may prescribe the conditions under which 
commissioned officers of the Service may be awarded military 
ribbons, medals, and decorations.
    (c) The authority vested by law in the Department of the 
Army, the Secretary of the Army, or other officers of the 
Department of the Army with respect to rights, privileges, 
immunities, and benefits referred to in subsection (a) shall be 
exercised, with respect to commissioned officers of the 
Service, by the Surgeon General.
    (d) Active service of commissioned officers of the Service 
shall be deemed to be active military service in the Armed 
Forces of the United States for the purposes of all laws 
administered by the Secretary of Veterans Affairs (except the 
Servicemen's Indemnity Act of 1951) and section 217 of the 
Social Security Act.
    (e) Active service of commissioned officers of the Service 
shall be deemed to be active military service in the Armed 
Forces of the United States for the purposes of all rights, 
privileges, immunities, and benefits now or hereafter provided 
under the Servicemembers Civil Relief Act (50 App. U.S.C. 501 
et seq.).
    (f) Active service of commissioned officers of the Service 
shall be deemed to be active military service in the Armed 
Forces of the United States for purposes of all laws related to 
discrimination on the basis of race, color, sex, ethnicity, 
age, religion, and disability.
           presentation of united states flag upon retirement
    Sec. 213. [214] (a) Presentation of Flag.--Upon the release 
of an officer of the commissioned corps of the Service from 
active commissioned service for retirement, the Secretary of 
Health and Human Services shall present a United States flag to 
the officer.
    (b) Multiple Presentations Not Authorized.--An officer is 
not eligible for presentation of a flag under subsection (a) if 
the officer has previously been presented a flag under this 
section or any other provision of law providing for the 
presentation of a United States flag incident to release from 
active service for retirement.
    (c) No Cost to Recipient.--The presentation of a flag under 
this section shall be at no cost to the recipient.
                          detail of personnel
    Sec. 214. \1\ [215] (a) The Secretary is authorized, upon 
the request of the head of an executive department, to detail 
officers or employees of the Service to such department for 
duty as agreed upon by the Secretary and the head of such 
department in order to cooperate in, or conduct work related 
to, the functions of such department or of the Service. When 
officers or employees are so detailed their salaries and 
allowances may be paid from working funds established as 
provided by law or may be paid by the Service from applicable 
appropriation and reimbursement may be made as agreed upon by 
the Secretary and the head of the executive department 
concerned. Officers detailed for duty with the Army, Navy, or 
Coast Guard shall be subject to the laws for the government of 
the service to which detailed.
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    \1\ Former section 213 was repealed by section 14 of Public Law 87-
649 (76 Stat. 499). Section 415(c) of title 37, United States Code, now 
applies to the matter with which former section 213 was concerned.
---------------------------------------------------------------------------
    (b) Upon the request of any State health authority or, in 
the case of work relating to mental health, any State mental 
health authority, personnel of the Service may be detailed by 
the Surgeon General for the purpose of assisting such State or 
political subdivision thereof in work related to the functions 
of the Service.
    (c) The Surgeon General may detail personnel of the Service 
to any appropriate committee of the Congress or to nonprofit 
educational research or other institutions engaged in health 
activities for special studies of scientific problems and for 
the dissemination of information relating to public health.
    (d) Personnel detailed under subsections (b) and (c) shall 
be paid from applicable appropriations of the Service except 
that, in accordance with regulations such personnel may be 
placed on leave without pay and paid by the State, subdivision, 
or institution to which they are detailed. In the case of 
detail of personnel under subsections (b) or (c) to be paid 
from applicable Service appropriations, the Secretary may 
condition such detail on an agreement by the State, 
subdivision, or institution concerned that such State, 
subdivision, or institution concerned shall reimburse the 
United States for the amount of such payments made by the 
Service. The services of personnel while detailed pursuant to 
this section shall be considered as having been performed in 
the Service for purposes of the computation of basic pay, 
promotion, retirement, compensation for injury or death, and 
the benefits provided by section 212.
    (e) Except with respect to the United States Coast Guard 
and the Department of Defense, and except as provided in 
agreements negotiated with officials at agencies where officers 
of the Commissioned Corps may be assigned, the Secretary shall 
have the sole authority to deploy any Commissioned Corps 
officer assigned under this section to an entity outside of the 
Department of Health and Human Services for service under the 
Secretary's direction in response to an urgent or emergency 
public health care need (as defined in section 203A(a)(5)).

                              regulations

    Sec. 215. [216] (a) The President shall from time to time 
prescribe regulations with respect to the appointment, 
promotion, retirement, termination of commission, title, pay, 
uniforms, allowances (including increased allowances for 
foreign service), and discipline of the commissioned corps of 
the Service.
    (b) The Surgeon General, with the approval of the 
Secretary, unless specifically otherwise provided, shall 
promulgate all other regulations necessary to the 
administration of the Service, including regulations with 
respect to uniforms for employees, and regulations with respect 
to the custody, use, and preservation of the records, papers, 
and property of the Service.
    (c) No regulations relating to qualifications for 
appointment of medical officers or employees shall give 
preference to any school of medicine.

               use of service in time of war or emergency

    Sec. 216. [217] In time of war, or of emergency proclaimed 
by the President, he may utilize the Service to such extent and 
in such manner as shall in his judgment promote the public 
interest. In time of war, or of emergency involving the 
national defense proclaimed by the President, he may by 
Executive order declare the commissioned corps of the Service 
to be a military service. Upon such declaration, and during the 
period of such war or such emergency or such part thereof as 
the President shall prescribe, the commissioned corps (a) shall 
constitute a branch of the land and naval forces of the United 
States, (b) shall, to the extent prescribed by regulations of 
the President, be subject to the Uniform Code of Military 
Justice, and (c) shall continue to operate as part of the 
Service except to the extent that the President may direct as 
Commander in Chief.

                       national advisory councils

    Sec. 217. [218] (a) Within 120 days of the date of the 
enactment of this subsection, the Secretary shall appoint and 
organize a National Advisory Council on Migrant Health 
(hereinafter in this subsection referred to as the Council) 
which shall advise, consult with, and make recommendations to, 
the Secretary on matters concerning the organization, 
operation, selection, and funding of migrant health centers and 
other entities under grants and contracts under section 329. 
\1\
---------------------------------------------------------------------------
    \1\ As a result of the amendments made by Public Law 104-299 (110 
Stat. 3626), the Public Health Service Act no longer contained a 
section 329, 340, or 340A, and section 330 of such Act was 
substantially revised. Section 330 now includes provisions that relate 
to medically underserved populations, to migratory and seasonal 
agricultural workers, to homeless individuals, and to residents of 
public housing. Section 402 of Public Law 107-251 (116 Stat. 1655) 
added a new section 340 that relates to a healthy communities access 
program.
---------------------------------------------------------------------------
    (b) The Council shall consist of fifteen members, at least 
twelve of whom shall be members of the governing boards of 
migrant health centers or other entities assisted under section 
329. \1\ Of such twelve members who are members of such 
governing boards, at least nine shall be chosen from among 
those members of such governing boards who are being served by 
such centers or grantees and who are familiar with the delivery 
of health care to migratory agricultural workers and seasonal 
agricultural workers. The remaining three Council members shall 
be individuals qualified by training and experience in the 
medical sciences or in the administration of health programs.
    (c) Each member of the Council shall hold office for a term 
of four years, except that (1) any member appointed to fill a 
vacancy occurring prior to the expiration of the term for which 
his predecessor was appointed shall be appointed for the 
remainder of such term; and (2) the terms of the members first 
taking office after the date of enactment of this subsection 
shall expire as follows: four shall expire four years after 
such date, four shall expire three years after such date, four 
shall expire two years after such date, and three shall expire 
one year after such date, as designated by the Secretary at the 
time of appointment.
    (d) Section 14(a) of the Federal Advisory Committee Act 
shall not apply to the Council.

                          training of officers

    Sec. 218. [218a] (a) Appropriations available for the pay 
and allowances of commissioned officers of the Service shall 
also be available for the pay and allowances of any such 
officer on active duty while attending any Federal or non-
Federal educational institution or training program and, 
subject to regulations of the President and to the limitation 
prescribed in such appropriations, for payment of his tuition, 
fees, and other necessary expenses incident to such attendance.
    (b) Any officer whose tuition, fees, and other necessary 
expenses are paid pursuant to subsection (a) while attending an 
educational institution or training program for a period in 
excess of thirty days shall be obligated to pay to the Service 
an amount equal to two times the total amount of such tuition, 
fees, and other necessary expenses received by such officer 
during such period, and two times the total amount of any 
compensation received by, and any allowance paid to, such 
officer during such period, if after return to active service 
such officer voluntarily leaves the Service within (1) six 
months, or (2) twice the period of such attendance, whichever 
is greater. Such subsequent period of service shall commence 
upon the cessation of such attendance and of any further 
continuous period of training duty for which no tuition and 
fees are paid by the Service and which is part of the officer's 
prescribed formal training program, whether such further 
training is at Service facility or otherwise. The Surgeon 
General may waive, in whole or in part, any payment which may 
be required by this subsection upon a determination that such 
payment would be inequitable or would not be in public 
interest.
    (c) A commissioned officer may be placed in leave without 
pay status while attending an educational institution or 
training program whenever the Secretary determines that such 
status is in the best interest of the Service. For purposes of 
computation of basic pay, promotion, retirement, compensation 
for injury or death, and the benefits provided by sections 212 
and 224, an officer in such status pursuant to the preceding 
sentence shall be considered as performing service in the 
Service and shall have an active service obligation as set 
forth in subsection (b) of this section.

                         annual and sick leave

    Sec. 219. [210-1] (a) In accordance with regulations of the 
President, commissioned officers of the Regular Corps and 
officers of the Reserve Corps on active duty may be granted 
annual leave and sick leave without any deductions from their 
pay and allowances: Provided, That such regulations shall not 
authorize annual leave to be accumulated in excess of sixty 
days.
    (d) \1\ For purposes of this section the term ``accumulated 
annual leave'' means unused accrued annual leave carried 
forward from one leave year into a succeeding leave year, and 
the term ``accrued annual leave'' means the annual leave 
accruing to an officer during one leave year.
---------------------------------------------------------------------------
    \1\ Former subsection (b) was repealed by section 14 of Public Law 
87-649 (76 Stat. 499). Section 503(b) of title 37, United States Code, 
now applies to the matter with which former subsection (b) was 
concerned. Former subsection (c) was repealed by section 311 of Public 
Law 96-76 (93 Stat. 586).
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                   promotion credit--assistant grade

    Sec. 220. [211c] Any medical officer of the Regular Corps 
of the Public Health Service who--
            (1)(A) was appointed to the assistant grade in the 
        Regular Corps and whose service in such Corps has been 
        continuous from the date of appointment or (B) may 
        hereafter be appointed to the assistant grade in the 
        Regular Corps, and
            (2) had or will have completed a medical internship 
        on the date of such appointment,
shall be credited with one year for purposes of promotion and 
seniority in grade, except that no such credit shall be 
authorized if the officer has received or will receive similar 
credit for his internship under other provisions of law. In the 
case of an officer on active duty on the effective date of this 
section who is entitled to the credit authorized herein, the 
one year shall be added to the promotion and seniority-in-grade 
credits with which he is credited on such date.

    rights, privileges, etc. of officers and surviving beneficiaries

    Sec. 221. [213a] (a) Commissioned officers of the Service 
or their surviving beneficiaries are entitled to all the 
rights, benefits, privileges, and immunities now or hereafter 
provided for commissioned officers of the Army or their 
surviving beneficiaries under the following provisions of title 
10, United States Code:
            (1) Section 1036, Escorts for dependents of 
        members: transportation and travel allowances.
            (2) Chapter 61, Retirement or Separation for 
        Physical Disability, except that sections 1201, 1202, 
        and 1203 do not apply to commissioned officers of the 
        Public Health Service who have been ordered to active 
        duty for training for a period of more than 30 days.
            (3) Chapter 69, Retired Grade, except sections 
        1370, 1374, 1375, and 1376(a).
            (4) Chapter 71, Computation of Retired Pay, except 
        formula No. 3 of section 1401.
            (5) Chapter 73, Retired Serviceman's Family 
        Protection Plan, Survivor Benefit Plan.
            (6) Chapter 75, Death Benefits.
            (7) Section 2771, Final settlement of accounts: 
        deceased members.
            (8) Chapter 163, Military Claims, but only when 
        commissioned officers of the Service are entitled to 
        military benefits under section 212 of this Act.
            (9) Section 2603, Acceptance of fellowships, 
        scholarships, or grants.
            (10) Section 2634 Motor vehicles: for members on 
        permanent change of station.
            (11) Section 1035, Deposit of savings.
            (12) Section 1552, Correction of military records: 
        claims incident thereto.
            (13) Section 1553, Review of discharge or 
        dismissal.
            (14) Section 1554, Review of retirement or 
        separation without pay for physical disability.
            (15) Section 1124, Cash awards for suggestions, 
        inventions, or scientific achievements.
            (16) Section 1052, Reimbursement for adoption 
        expenses.
            (17) Section 1059, Transitional compensation and 
        commissary and exchange benefits for dependents of 
        members separated for dependent abuse.
    (b) The authority vested by title 10, United States Code, 
in the ``military departments'', ``the Secretary concerned'', 
or ``the Secretary of Defense'' with respect to the rights, 
privileges, immunities, and benefits referred to in subsection 
(a) shall be exercised, with respect to commissioned officers 
of the Service, by the Secretary of Health, Education, and 
Welfare or his designee.

                    advisory councils or committees

    Sec. 222. [217a] (a) The Secretary may, without regard to 
the provisions of title 5, United States Code, governing 
appointments in the competitive service, and without regard to 
the provisions of chapter 51 and subchapter III of chapter 53 
of such title relating to classification and General Schedule 
pay rates, from time to time, appoint such advisory councils or 
committees (in addition to those authorized to be established 
under other provisions of law), for such periods of time, as he 
deems desirable with such period commencing on a date specified 
by the Secretary for the purpose of advising him in connection 
with any of his functions.
    (b) Members of any advisory council or committee appointed 
under this section who are not regular full-time employees of 
the United States shall, while attending meetings or 
conferences of such council or committee or otherwise engaged 
on business of such council or committee receive compensation 
and allowances as provided in section 208(c) for members of 
national advisory councils established under this Act.
    (c) Upon appointment of any such council or committee, the 
Secretary may delegate to such council or committee such 
advisory functions relating to grants-in-aid for research or 
training projects or programs, in the areas or fields with 
which such council or committee is concerned, as the Secretary 
determines to be appropriate.

                           volunteer services

    Sec. 223. [217b] Subject to regulations, volunteer and 
uncompensated services may be accepted by the Secretary, or by 
any other officer or employee of the Department of Health and 
Human Services designated by him, for use in the operation of 
any health care facility or in the provision of health care.

          defense of certain malpractice and negligence suits

    Sec. 224. [233] (a) The remedy against the United States 
provided by sections 1346(b) and 2672 of title 28, or by 
alternative benefits provided by the United States where the 
availability of such benefits precludes a remedy under section 
1346(b) of title 28, for damage for personal injury, including 
death, resulting from the performance of medical, surgical, 
dental, or related functions, including the conduct of clinical 
studies or investigation, by any commissioned officer or 
employee of the Public Health Service while acting within the 
scope of his office or employment, shall be exclusive of any 
other civil action or proceeding by reason of the same subject-
matter against the officer or employee (or his estate) whose 
act or omission gave rise to the claim.
    (b) The Attorney General shall defend any civil action or 
proceeding brought in any court against any person referred to 
in subsection (a) of this section (or his estate) for any such 
damage or injury. Any such person against whom such civil 
action or proceeding is brought shall deliver within such time 
after date of service or knowledge of service as determined by 
the Attorney General, all process served upon him or an 
attested true copy thereof to his immediate superior or to 
whomever was designated by the Secretary to receive such papers 
and such persons shall promptly furnish copies of the pleading 
and process therein to the United States attorney for the 
district embracing the place wherein the proceeding is brought, 
to the Attorney General, and to the Secretary.
    (c) Upon a certification by the Attorney General that the 
defendant was acting in the scope of his employment at the time 
of the incident out of which the suit arose, any such civil 
action or proceeding commenced in a State court shall be 
removed without bond at any time before trial by the Attorney 
General to the district court of the United States of the 
district and division embracing the place wherein it is pending 
and the proceeding deemed a tort action brought against the 
United States under the provisions of title 28 and all 
references thereto. Should a United States district court 
determine on a hearing on a motion to remand held before a 
trial on the merit that the case so removed is one in which a 
remedy by suit within the meaning of subsection (a) of this 
section is not available against the United States, the case 
shall be remanded to the State Court: Provided, That where such 
a remedy is precluded because of the availability of a remedy 
through proceedings for compensation or other benefits from the 
United States as provided by any other law, the case shall be 
dismissed, but in the event the running of any limitation of 
time for commencing, or filing an application or claim in, such 
proceedings for compensation or other benefits shall be deemed 
to have been suspended during the pendency of the civil action 
or proceeding under this section.
    (d) The Attorney General may compromise or settle any claim 
asserted in such civil action or proceeding in the manner 
provided in section 2677 of title 28 and with the same effect.
    (e) For purposes of this section, the provisions of section 
2680(h) of title 28 shall not apply to assault or battery 
arising out of negligence in the performance of medical, 
surgical, dental, or related functions, including the conduct 
of clinical studies or investigations.
    (f) The Secretary or his designee may, to the extent that 
he deems appropriate, hold harmless or provide liability 
insurance for any officer or employee of the Public Health 
Service for damage for personal injury, including death, 
negligently caused by such officer or employee while acting 
within the scope of his office or employment and as a result of 
the performance of medical, surgical, dental, or related 
functions, including the conduct of clinical studies or 
investigations, if such employee is assigned to a foreign 
country or detailed to a State or political subdivision thereof 
or to a non-profit institution, and if the circumstances are 
such as are likely to preclude the remedies of third persons 
against the United States described in section 2679(b) of title 
28, for such damage or injury.
    (g)(1)(A) For purposes of this section and subject to the 
approval by the Secretary of an application under subparagraph 
(D), an entity described in paragraph (4), and any officer, 
governing board member, or employee of such an entity, and any 
contractor of such an entity who is a physician or other 
licensed or certified health care practitioner (subject to 
paragraph (5)), shall be deemed to be an employee of the Public 
Health Service for a calendar year that begins during a fiscal 
year for which a transfer was made under subsection (k)(3) 
(subject to paragraph (3)). The remedy against the United 
States for an entity described in paragraph (4) and any 
officer, governing board member, employee, or contractor 
(subject to paragraph (5)) of such an entity who is deemed to 
be an employee of the Public Health Service pursuant to this 
paragraph shall be exclusive of any other civil action or 
proceeding to the same extent as the remedy against the United 
States is exclusive pursuant to subsection (a).
    (B) The deeming of any entity or officer, governing board 
member, employee, or contractor of the entity to be an employee 
of the Public Health Service for purposes of this section shall 
apply with respect to services provided--
            (i) to all patients of the entity, and
            (ii) subject to subparagraph (C), to individuals 
        who are not patients of the entity.
    (C) Subparagraph (B)(ii) applies to services provided to 
individuals who are not patients of an entity if the Secretary 
determines, after reviewing an application submitted under 
subparagraph (D), that the provision of the services to such 
individuals--
            (i) benefits patients of the entity and general 
        populations that could be served by the entity through 
        community-wide intervention efforts within the 
        communities served by such entity;
            (ii) facilitates the provision of services to 
        patients of the entity; or
            (iii) are otherwise required under an employment 
        contract (or similar arrangement) between the entity 
        and an officer, governing board member, employee, or 
        contractor of the entity.
    (D) The Secretary may not under subparagraph (A) deem an 
entity or an officer, governing board member, employee, or 
contractor of the entity to be an employee of the Public Health 
Service for purposes of this section, and may not apply such 
deeming to services described in subparagraph (B)(ii), unless 
the entity has submitted an application for such deeming to the 
Secretary in such form and such manner as the Secretary shall 
prescribe. The application shall contain detailed information, 
along with supporting documentation, to verify that the entity, 
and the officer, governing board member, employee, or 
contractor of the entity, as the case may be, meets the 
requirements of subparagraphs (B) and (C) of this paragraph and 
that the entity meets the requirements of paragraphs (1) 
through (4) of subsection (h).
    (E) The Secretary shall make a determination of whether an 
entity or an officer, governing board member, employee, or 
contractor of the entity is deemed to be an employee of the 
Public Health Service for purposes of this section within 30 
days after the receipt of an application under subparagraph 
(D). The determination of the Secretary that an entity or an 
officer, governing board member, employee, or contractor of the 
entity is deemed to be an employee of the Public Health Service 
for purposes of this section shall apply for the period 
specified by the Secretary under subparagraph (A).
    (F) Once the Secretary makes a determination that an entity 
or an officer, governing board member, employee, or contractor 
of an entity is deemed to be an employee of the Public Health 
Service for purposes of this section, the determination shall 
be final and binding upon the Secretary and the Attorney 
General and other parties to any civil action or proceeding. 
Except as provided in subsection (i), the Secretary and the 
Attorney General may not determine that the provision of 
services which are the subject of such a determination are not 
covered under this section.
    (G) In the case of an entity described in paragraph (4) 
that has not submitted an application under subparagraph (D):
            (i) The Secretary may not consider the entity in 
        making estimates under subsection (k)(1).
            (ii) This section does not affect any authority of 
        the entity to purchase medical malpractice liability 
        insurance coverage with Federal funds provided to the 
        entity under section 329, 330, or 340A.
    (H) In the case of an entity described in paragraph (4) for 
which an application under subparagraph (D) is in effect, the 
entity may, through notifying the Secretary in writing, elect 
to terminate the applicability of this subsection to the 
entity. With respect to such election by the entity:
            (i) The election is effective upon the expiration 
        of the 30-day period beginning on the date on which the 
        entity submits such notification.
            (ii) Upon taking effect, the election terminates 
        the applicability of this subsection to the entity and 
        each officer, governing board member, employee, and 
        contractor of the entity.
            (iii) Upon the effective date for the election, 
        clauses (i) and (ii) of subparagraph (G) apply to the 
        entity to the same extent and in the same manner as 
        such clauses apply to an entity that has not submitted 
        an application under subparagraph (D).
            (iv) If after making the election the entity 
        submits an application under subparagraph (D), the 
        election does not preclude the Secretary from approving 
        the application (and \1\ thereby restoring the 
        applicability of this subsection to the entity and each 
        officer, governing board member, employee, and 
        contractor of the entity, subject to the provisions of 
        this subsection and the subsequent provisions of this 
        section.
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    \1\ So in law. See section 5(a) of Public Law 104-73 (109 Stat. 
779). There is no closing parenthesis.
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    (2) If, with respect to an entity or person deemed to be an 
employee for purposes of paragraph (1), a cause of action is 
instituted against the United States pursuant to this section, 
any claim of the entity or person for benefits under an 
insurance policy with respect to medical malpractice relating 
to such cause of action shall be subrogated to the United 
States.
    (3) This subsection shall apply with respect to a cause of 
action arising from an act or omission which occurs on or after 
January 1, 1993.
    (4) An entity described in this paragraph is a public or 
non-profit private entity receiving Federal funds under section 
330.
    (5) For purposes of paragraph (1), an individual may be 
considered a contractor of an entity described in paragraph (4) 
only if--
            (A) the individual normally performs on average at 
        least 32\1/2\ hours of service per week for the entity 
        for the period of the contract; or
            (B) in the case of an individual who normally 
        performs an average of less than 32\1/2\ hours of 
        services per week for the entity for the period of the 
        contract, the individual is a licensed or certified 
        provider of services in the fields of family practice, 
        general internal medicine, general pediatrics, or 
        obstetrics and gynecology.
    (h) The Secretary may not approve an application under 
subsection (g)(1)(D) unless the Secretary determines that the 
entity--
            (1) has implemented appropriate policies and 
        procedures to reduce the risk of malpractice and the 
        risk of lawsuits arising out of any health or health-
        related functions performed by the entity;
            (2) has reviewed and verified the professional 
        credentials, references, claims history, fitness, 
        professional review organization findings, and license 
        status of its physicians and other licensed or 
        certified health care practitioners, and, where 
        necessary, has obtained the permission from these 
        individuals to gain access to this information;
            (3) has no history of claims having been filed 
        against the United States as a result of the 
        application of this section to the entity or its 
        officers, employees, or contractors as provided for 
        under this section, or, if such a history exists, has 
        fully cooperated with the Attorney General in defending 
        against any such claims and either has taken, or will 
        take, any necessary corrective steps to assure against 
        such claims in the future; and
            (4) will fully cooperate with the Attorney General 
        in providing information relating to an estimate 
        described under subsection (k).
    (i)(1) Notwithstanding subsection (g)(1), the Attorney 
General, in consultation with the Secretary, may on the record 
determine, after notice and opportunity for a full and fair 
hearing, that an individual physician or other licensed or 
certified health care practitioner who is an officer, employee, 
or contractor of an entity described in subsection (g)(4) shall 
not be deemed to be an employee of the Public Health Service 
for purposes of this section, if treating such individual as 
such an employee would expose the Government to an unreasonably 
high degree of risk of loss because such individual--
            (A) does not comply with the policies and 
        procedures that the entity has implemented pursuant to 
        subsection (h)(1);
            (B) has a history of claims filed against him or 
        her as provided for under this section that is outside 
        the norm for licensed or certified health care 
        practitioners within the same specialty;
            (C) refused to reasonably cooperate with the 
        Attorney General in defending against any such claim;
            (D) provided false information relevant to the 
        individual's performance of his or her duties to the 
        Secretary, the Attorney General, or an applicant for or 
        recipient of funds under this Act; or
            (E) was the subject of disciplinary action taken by 
        a State medical licensing authority or a State or 
        national professional society.
    (2) A final determination by the Attorney General under 
this subsection that an individual physician or other licensed 
or certified health care professional shall not be deemed to be 
an employee of the Public Health Service shall be effective 
upon receipt by the entity employing such individual of notice 
of such determination, and shall apply only to acts or 
omissions occurring after the date such notice is received.
    (j) In the case of a health care provider who is an 
officer, employee, or contractor of an entity described in 
subsection (g)(4), section 335(e) shall apply with respect to 
the provider to the same extent and in the same manner as such 
section applies to any member of the National Health Service 
Corps.
    (k)(1)(A) For each fiscal year, the Attorney General, in 
consultation with the Secretary, shall estimate by the 
beginning of the year the amount of all claims which are 
expected to arise under this section (together with related 
fees and expenses of witnesses) for which payment is expected 
to be made in accordance with section 1346 and chapter 171 of 
title 28, United States Code, from the acts or omissions, 
during the calendar year that begins during that fiscal year, 
of entities described in subsection (g)(4) and of officers, 
employees, or contractors (subject to subsection (g)(5)) of 
such entities.
    (B) The estimate under subparagraph (A) shall take into 
account--
            (i) the value and frequency of all claims for 
        damage for personal injury, including death, resulting 
        from the performance of medical, surgical, dental, or 
        related functions by entities described in subsection 
        (g)(4) or by officers, employees, or contractors 
        (subject to subsection (g)(5)) of such entities who are 
        deemed to be employees of the Public Health Service 
        under subsection (g)(1) that, during the preceding 5-
        year period, are filed under this section or, with 
        respect to years occurring before this subsection takes 
        effect, are filed against persons other than the United 
        States,
            (ii) the amounts paid during that 5-year period on 
        all claims described in clause (i), regardless of when 
        such claims were filed, adjusted to reflect payments 
        which would not be permitted under section 1346 and 
        chapter 171 of title 28, United States Code, and
            (iii) amounts in the fund established under 
        paragraph (2) but unspent from prior fiscal years.
    (2) Subject to appropriations, for each fiscal year, the 
Secretary shall establish a fund of an amount equal to the 
amount estimated under paragraph (1) that is attributable to 
entities receiving funds under each of the grant programs 
described in paragraph (4) of subsection (g), but not to exceed 
a total of $10,000,000 for each such fiscal year. 
Appropriations for purposes of this paragraph shall be made 
separate from appropriations made for purposes of sections 329, 
330 and 340A.
    (3) In order for payments to be made for judgments against 
the United States (together with related fees and expenses of 
witnesses) pursuant to this section arising from the acts or 
omissions of entities described in subsection (g)(4) and of 
officers, \1\ employees, or contractors (subject to subsection 
(g)(5)) of such entities, the total amount contained within the 
fund established by the Secretary under paragraph (2) for a 
fiscal year shall be transferred not later than the December 31 
that occurs during the fiscal year to the appropriate accounts 
in the Treasury.
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    \1\ Section 3(2) of Public Law 104-73 (109 Stat. 778) provides that 
subsection (k)(3) is amended by inserting ``governing board member,'' 
after ``officer,''. The amendment cannot be executed because the latter 
term does not appear. (Compare ``officer,'' and ``officers,''.)
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    (l)(1) If a civil action or proceeding is filed in a State 
court against any entity described in subsection (g)(4) or any 
officer, governing board member, employee, or any contractor of 
such an entity for damages described in subsection (a), the 
Attorney General, within 15 days after being notified of such 
filing, shall make an appearance in such court and advise such 
court as to whether the Secretary has determined under 
subsections (g) and (h), that such entity, officer, governing 
board member, employee, or contractor of the entity is deemed 
to be an employee of the Public Health Service for purposes of 
this section with respect to the actions or omissions that are 
the subject of such civil action or proceeding. Such advice 
shall be deemed to satisfy the provisions of subsection (c) 
that the Attorney General certify that an entity, officer, 
governing board member, employee, or contractor of the entity 
was acting within the scope of their employment or 
responsibility.
    (2) If the Attorney General fails to appear in State court 
within the time period prescribed under paragraph (1), upon 
petition of any entity or officer, governing board member, 
employee, or contractor of the entity named, the civil action 
or proceeding shall be removed to the appropriate United States 
district court. The civil action or proceeding shall be stayed 
in such court until such court conducts a hearing, and makes a 
determination, as to the appropriate forum or procedure for the 
assertion of the claim for damages described in subsection (a) 
and issues an order consistent with such determination.
    (m)(1) An entity or officer, governing board member, 
employee, or contractor of an entity described in subsection 
(g)(1) shall, for purposes of this section, be deemed to be an 
employee of the Public Health Service with respect to services 
provided to individuals who are enrollees of a managed care 
plan if the entity contracts with such managed care plan for 
the provision of services.
    (2) Each managed care plan which enters into a contract 
with an entity described in subsection (g)(4) shall deem the 
entity and any officer, governing board member, employee, or 
contractor of the entity as meeting whatever malpractice 
coverage requirements such plan may require of contracting 
providers for a calendar year if such entity or officer, 
governing board member, employee, or contractor of the entity 
has been deemed to be an employee of the Public Health Service 
for purposes of this section for such calendar year. Any plan 
which is found by the Secretary on the record, after notice and 
an opportunity for a full and fair hearing, to have violated 
this subsection shall upon such finding cease, for a period to 
be determined by the Secretary, to receive and to be eligible 
to receive any Federal funds under titles XVIII or XIX of the 
Social Security Act.
    (3) For purposes of this subsection, the term ``managed 
care plan'' shall mean health maintenance organizations and 
similar entities that contract at-risk with payors for the 
provision of health services or plan enrollees and which 
contract with providers (such as entities described in 
subsection (g)(4)) for the delivery of such services to plan 
enrollees.
    (n)(1) Not later than one year after the date of the 
enactment of the Federally Supported Health Centers Assistance 
Act of 1995, the Comptroller General of the United States shall 
submit to the Congress a report on the following:
            (A) The medical malpractice liability claims 
        experience of entities that have been deemed to be 
        employees for purposes of this section.
            (B) The risk exposure of such entities.
            (C) The value of private sector risk-management 
        services, and the value of risk-management services and 
        procedures required as a condition of receiving a grant 
        under section 329, 330, or 340A.
            (D) A comparison of the costs and the benefits to 
        taxpayers of maintaining medical malpractice liability 
        coverage for such entities pursuant to this section, 
        taking into account--
                    (i) a comparison of the costs of premiums 
                paid by such entities for private medical 
                malpractice liability insurance with the cost 
                of coverage pursuant to this section; and
                    (ii) an analysis of whether the cost of 
                premiums for private medical malpractice 
                liability insurance coverage is consistent with 
                the liability claims experience of such 
                entities.
    (2) The report under paragraph (1) shall include the 
following:
            (A) A comparison of--
                    (i) an estimate of the aggregate amounts 
                that such entities (together with the officers, 
                governing board members, employees, and 
                contractors of such entities who have been 
                deemed to be employees for purposes of this 
                section) would have directly or indirectly paid 
                in premiums to obtain medical malpractice 
                liability insurance coverage if this section 
                were not in effect; with
                    (ii) the aggregate amounts by which the 
                grants received by such entities under this Act 
                were reduced pursuant to subsection (k)(2).
            (B) A comparison of--
                    (i) an estimate of the amount of privately 
                offered such insurance that such entities 
                (together with the officers, governing board 
                members, employees, and contractors of such 
                entities who have been deemed to be employees 
                for purposes of this section) purchased during 
                the three-year period beginning on January 1, 
                1993; with
                    (ii) an estimate of the amount of such 
                insurance that such entities (together with the 
                officers, governing board members, employees, 
                and contractors of such entities who have been 
                deemed to be employees for purposes of this 
                section) will purchase after the date of the 
                enactment of the Federally Supported Health 
                Centers Assistance Act of 1995.
            (C) An estimate of the medical malpractice 
        liability loss history of such entities for the 10-year 
        period preceding October 1, 1996, including but not 
        limited to the following:
                    (i) Claims that have been paid and that are 
                estimated to be paid, and legal expenses to 
                handle such claims that have been paid and that 
                are estimated to be paid, by the Federal 
                Government pursuant to deeming entities as 
                employees for purposes of this section.
                    (ii) Claims that have been paid and that 
                are estimated to be paid, and legal expenses to 
                handle such claims that have been paid and that 
                are estimated to be paid, by private medical 
                malpractice liability insurance.
          (D) An analysis of whether the cost of premiums for 
        private medical malpractice liability insurance 
        coverage is consistent with the liability claims 
        experience of entities that have been deemed as 
        employees for purposes of this section.
    (3) In preparing the report under paragraph (1), the 
Comptroller General of the United States shall consult with 
public and private entities with expertise on the matters with 
which the report is concerned.
    (o)(1) For purposes of this section, a free clinic health 
professional shall in providing a qualifying health service to 
an individual, or an officer, governing board member, employee, 
or contractor of a free clinic shall in providing services for 
the free clinic, be deemed to be an employee of the Public 
Health Service for a calendar year that begins during a fiscal 
year for which a transfer was made under paragraph (6)(D). The 
preceding sentence is subject to the provisions of this 
subsection.
    (2) In providing a health service to an individual, a 
health care practitioner shall for purposes of this subsection 
be considered to be a free clinic health professional if the 
following conditions are met:
            (A) The service is provided to the individual at a 
        free clinic, or through offsite programs or events 
        carried out by the free clinic.
            (B) The free clinic is sponsoring the health care 
        practitioner pursuant to paragraph (5)(C).
            (C) The service is a qualifying health service (as 
        defined in paragraph (4)).
            (D) Neither the health care practitioner nor the 
        free clinic receives any compensation for the service 
        from the individual or from any third-party payor 
        (including reimbursement under any insurance policy or 
        health plan, or under any Federal or State health 
        benefits program). With respect to compliance with such 
        condition:
                    (i) The health care practitioner may 
                receive repayment from the free clinic for 
                reasonable expenses incurred by the health care 
                practitioner in the provision of the service to 
                the individual.
                    (ii) The free clinic may accept voluntary 
                donations for the provision of the service by 
                the health care practitioner to the individual.
            (E) Before the service is provided, the health care 
        practitioner or the free clinic provides written notice 
        to the individual of the extent to which the legal 
        liability of the health care practitioner is limited 
        pursuant to this subsection (or in the case of an 
        emergency, the written notice is provided to the 
        individual as soon after the emergency as is 
        practicable). If the individual is a minor or is 
        otherwise legally incompetent, the condition under this 
        subparagraph is that the written notice be provided to 
        a legal guardian or other person with legal 
        responsibility for the care of the individual.
            (F) At the time the service is provided, the health 
        care practitioner is licensed or certified in 
        accordance with applicable law regarding the provision 
        of the service.
    (3)(A) For purposes of this subsection, the term ``free 
clinic'' means a health care facility operated by a nonprofit 
private entity meeting the following requirements:
            (i) The entity does not, in providing health 
        services through the facility, accept reimbursement 
        from any third-party payor (including reimbursement 
        under any insurance policy or health plan, or under any 
        Federal or State health benefits program).
            (ii) The entity, in providing health services 
        through the facility, either does not impose charges on 
        the individuals to whom the services are provided, or 
        imposes a charge according to the ability of the 
        individual involved to pay the charge.
            (iii) The entity is licensed or certified in 
        accordance with applicable law regarding the provision 
        of health services.
    (B) With respect to compliance with the conditions under 
subparagraph (A), the entity involved may accept voluntary 
donations for the provision of services.
    (4) For purposes of this subsection, the term ``qualifying 
health service'' means any medical assistance required or 
authorized to be provided in the program under title XIX of the 
Social Security Act, without regard to whether the medical 
assistance is included in the plan submitted under such program 
by the State in which the health care practitioner involved 
provides the medical assistance. References in the preceding 
sentence to such program shall as applicable be considered to 
be references to any successor to such program.
    (5) Subsection (g) (other than paragraphs (3) through (5)) 
and subsections (h), (i), and (l) apply to a health care 
practitioner for purposes of this subsection to the same extent 
and in the same manner as such subsections apply to an officer, 
governing board member, employee, or contractor of an entity 
described in subsection (g)(4), subject to paragraph (6) and 
subject to the following:
            (A) The first sentence of paragraph (1) applies in 
        lieu of the first sentence of subsection (g)(1)(A).
            (B) This subsection may not be construed as deeming 
        any free clinic to be an employee of the Public Health 
        Service for purposes of this section.
            (C) With respect to a free clinic, a health care 
        practitioner is not a free clinic health professional 
        unless the free clinic sponsors the health care 
        practitioner. For purposes of this subsection, the free 
        clinic shall be considered to be sponsoring the health 
        care practitioner if--
                    (i) with respect to the health care 
                practitioner, the free clinic submits to the 
                Secretary an application meeting the 
                requirements of subsection (g)(1)(D); and
                    (ii) the Secretary, pursuant to subsection 
                (g)(1)(E), determines that the health care 
                practitioner is deemed to be an employee of the 
                Public Health Service.
            (D) In the case of a health care practitioner who 
        is determined by the Secretary pursuant to subsection 
        (g)(1)(E) to be a free clinic health professional, this 
        subsection applies to the health care practitioner 
        (with respect to the free clinic sponsoring the health 
        care practitioner pursuant to subparagraph (C)) for any 
        cause of action arising from an act or omission of the 
        health care practitioner occurring on or after the date 
        on which the Secretary makes such determination.
            (E) Subsection (g)(1)(F) applies to a health care 
        practitioner for purposes of this subsection only to 
        the extent that, in providing health services to an 
        individual, each of the conditions specified in 
        paragraph (2) is met.
    (6)(A) For purposes of making payments for judgments 
against the United States (together with related fees and 
expenses of witnesses) pursuant to this section arising from 
the acts or omissions of free clinic health professionals, 
there is authorized to be appropriated $10,000,000 for each 
fiscal year.
    (B) The Secretary shall establish a fund for purposes of 
this subsection. Each fiscal year amounts appropriated under 
subparagraph (A) shall be deposited in such fund.
    (C) Not later than May 1 of each fiscal year, the Attorney 
General, in consultation with the Secretary, shall submit to 
the Congress a report providing an estimate of the amount of 
claims (together with related fees and expenses of witnesses) 
that, by reason of the acts or omissions of free clinic health 
professionals, will be paid pursuant to this section during the 
calendar year that begins in the following fiscal year. 
Subsection (k)(1)(B) applies to the estimate under the 
preceding sentence regarding free clinic health professionals 
to the same extent and in the same manner as such subsection 
applies to the estimate under such subsection regarding 
officers, governing board members, employees, and contractors 
of entities described in subsection (g)(4).
    (D) Not later than December 31 of each fiscal year, the 
Secretary shall transfer from the fund under subparagraph (B) 
to the appropriate accounts in the Treasury an amount equal to 
the estimate made under subparagraph (C) for the calendar year 
beginning in such fiscal year, subject to the extent of amounts 
in the fund.
    (7)(A) This subsection takes effect on the date of the 
enactment of the first appropriations Act that makes an 
appropriation under paragraph (6)(A), except as provided in 
subparagraph (B)(i).
    (B)(i) Effective on the date of the enactment of the Health 
Insurance Portability and Accountability Act of 1996--
            (I) the Secretary may issue regulations for 
        carrying out this subsection, and the Secretary may 
        accept and consider applications submitted pursuant to 
        paragraph (5)(C); and
            (II) reports under paragraph (6)(C) may be 
        submitted to the Congress.
    (ii) For the first fiscal year for which an appropriation 
is made under subparagraph (A) of paragraph (6), if an estimate 
under subparagraph (C) of such paragraph has not been made for 
the calendar year beginning in such fiscal year, the transfer 
under subparagraph (D) of such paragraph shall be made 
notwithstanding the lack of the estimate, and the transfer 
shall be made in an amount equal to the amount of such 
appropriation.
    (p) Administration of Smallpox Countermeasures by Health 
Professionals.--
            (1) In general.--For purposes of this section, and 
        subject to other provisions of this subsection, a 
        covered person shall be deemed to be an employee of the 
        Public Health Service with respect to liability arising 
        out of administration of a covered countermeasure 
        against smallpox to an individual during the effective 
        period of a declaration by the Secretary under 
        paragraph (2)(A).
            (2) Declaration by secretary concerning 
        countermeasure against smallpox.--
                    (A) Authority to issue declaration.--
                            (i) In general.--The Secretary may 
                        issue a declaration, pursuant to this 
                        paragraph, concluding that an actual or 
                        potential bioterrorist incident or 
                        other actual or potential public health 
                        emergency makes advisable the 
                        administration of a covered 
                        countermeasure to a category or 
                        categories of individuals.
                            (ii) Covered countermeasure.--The 
                        Secretary shall specify in such 
                        declaration the substance or substances 
                        that shall be considered covered 
                        countermeasures (as defined in 
                        paragraph (7)(A)) for purposes of 
                        administration to individuals during 
                        the effective period of the 
                        declaration.
                            (iii) Effective period.--The 
                        Secretary shall specify in such 
                        declaration the beginning and ending 
                        dates of the effective period of the 
                        declaration, and may subsequently amend 
                        such declaration to shorten or extend 
                        such effective period, provided that 
                        the new closing date is after the date 
                        when the declaration is amended.
                            (iv) Publication.--The Secretary 
                        shall promptly publish each such 
                        declaration and amendment in the 
                        Federal Register.
                    (B) Liability of united states only for 
                administrations within scope of declaration.--
                Except as provided in paragraph (5)(B)(ii), the 
                United States shall be liable under this 
                subsection with respect to a claim arising out 
                of the administration of a covered 
                countermeasure to an individual only if--
                            (i) the countermeasure was 
                        administered by a qualified person, for 
                        a purpose stated in paragraph 
                        (7)(A)(i), and during the effective 
                        period of a declaration by the 
                        Secretary under subparagraph (A) with 
                        respect to such countermeasure; and
                            (ii)(I) the individual was within a 
                        category of individuals covered by the 
                        declaration; or
                            (II) the qualified person 
                        administering the countermeasure had 
                        reasonable grounds to believe that such 
                        individual was within such category.
                    (C) Presumption of administration within 
                scope of declaration in case of accidental 
                vaccinia inoculation.--
                            (i) In general.--If vaccinia 
                        vaccine is a covered countermeasure 
                        specified in a declaration under 
                        subparagraph (A), and an individual to 
                        whom the vaccinia vaccine is not 
                        administered contracts vaccinia, then, 
                        under the circumstances specified in 
                        clause (ii), the individual--
                                    (I) shall be rebuttably 
                                presumed to have contracted 
                                vaccinia from an individual to 
                                whom such vaccine was 
                                administered as provided by 
                                clauses (i) and (ii) of 
                                subparagraph (B); and
                                    (II) shall (unless such 
                                presumption is rebutted) be 
                                deemed for purposes of this 
                                subsection to be an individual 
                                to whom a covered 
                                countermeasure was administered 
                                by a qualified person in 
                                accordance with the terms of 
                                such declaration and as 
                                described by subparagraph (B).
                            (ii) Circumstances in which 
                        presumption applies.--The presumption 
                        and deeming stated in clause (i) shall 
                        apply if--
                                    (I) the individual 
                                contracts vaccinia during the 
                                effective period of a 
                                declaration under subparagraph 
                                (A) or by the date 30 days 
                                after the close of such period; 
                                or
                                    (II) the individual has 
                                resided with, or has had 
                                contact with, an individual to 
                                whom such vaccine was 
                                administered as provided by 
                                clauses (i) and (ii) of 
                                subparagraph (B) and contracts 
                                vaccinia after such date.
                    (D) Acts and omissions deemed to be within 
                scope of employment.--
                            (i) In general.--In the case of a 
                        claim arising out of alleged 
                        transmission of vaccinia from an 
                        individual described in clause (ii), 
                        acts or omissions by such individual 
                        shall be deemed to have been taken 
                        within the scope of such individual's 
                        office or employment for purposes of--
                                    (I) subsection (a); and
                                    (II) section 1346(b) and 
                                chapter 171 of title 28, United 
                                States Code.
                            (ii) Individuals to whom deeming 
                        applies.--An individual is described by 
                        this clause if--
                                    (I) vaccinia vaccine was 
                                administered to such individual 
                                as provided by subparagraph 
                                (B); and
                                    (II) such individual was 
                                within a category of 
                                individuals covered by a 
                                declaration under subparagraph 
                                (A)(i).
            (3) Exhaustion; exclusivity; offset.--
                    (A) Exhaustion.--
                            (i) In general.--A person may not 
                        bring a claim under this subsection 
                        unless such person has exhausted such 
                        remedies as are available under part C 
                        of this title, except that if the 
                        Secretary fails to make a final 
                        determination on a request for benefits 
                        or compensation filed in accordance 
                        with the requirements of such part 
                        within 240 days after such request was 
                        filed, the individual may seek any 
                        remedy that may be available under this 
                        section.
                            (ii) Tolling of statute of 
                        limitations.--The time limit for filing 
                        a claim under this subsection, or for 
                        filing an action based on such claim, 
                        shall be tolled during the pendency of 
                        a request for benefits or compensation 
                        under part C of this title.
                            (iii) Construction.--This 
                        subsection shall not be construed as 
                        superseding or otherwise affecting the 
                        application of a requirement, under 
                        chapter 171 of title 28, United States 
                        Code, to exhaust administrative 
                        remedies.
                    (B) Exclusivity.--The remedy provided by 
                subsection (a) shall be exclusive of any other 
                civil action or proceeding for any claim or 
                suit this subsection encompasses, except for a 
                proceeding under part C of this title.
                    (C) Offset.--The value of all compensation 
                and benefits provided under part C of this 
                title for an incident or series of incidents 
                shall be offset against the amount of an award, 
                compromise, or settlement of money damages in a 
                claim or suit under this subsection based on 
                the same incident or series of incidents.
            (4) Certification of action by attorney general.--
        Subsection (c) applies to actions under this 
        subsection, subject to the following provisions:
                    (A) Nature of certification.--The 
                certification by the Attorney General that is 
                the basis for deeming an action or proceeding 
                to be against the United States, and for 
                removing an action or proceeding from a State 
                court, is a certification that the action or 
                proceeding is against a covered person and is 
                based upon a claim alleging personal injury or 
                death arising out of the administration of a 
                covered countermeasure.
                    (B) Certification of attorney general 
                conclusive.--The certification of the Attorney 
                General of the facts specified in subparagraph 
                (A) shall conclusively establish such facts for 
                purposes of jurisdiction pursuant to this 
                subsection.
            (5) Covered person to cooperate with united 
        states.--
                    (A) In general.--A covered person shall 
                cooperate with the United States in the 
                processing and defense of a claim or action 
                under this subsection based upon alleged acts 
                or omissions of such person.
                    (B) Consequences of failure to cooperate.--
                Upon the motion of the United States or any 
                other party and upon finding that such person 
                has failed to so cooperate--
                            (i) the court shall substitute such 
                        person as the party defendant in place 
                        of the United States and, upon motion, 
                        shall remand any such suit to the court 
                        in which it was instituted if it 
                        appears that the court lacks subject 
                        matter jurisdiction;
                            (ii) the United States shall not be 
                        liable based on the acts or omissions 
                        of such person; and
                            (iii) the Attorney General shall 
                        not be obligated to defend such action.
            (6) Recourse against covered person in case of 
        gross misconduct or contract violation.--
                    (A) In general.--Should payment be made by 
                the United States to any claimant bringing a 
                claim under this subsection, either by way of 
                administrative determination, settlement, or 
                court judgment, the United States shall have, 
                notwithstanding any provision of State law, the 
                right to recover for that portion of the 
                damages so awarded or paid, as well as interest 
                and any costs of litigation, resulting from the 
                failure of any covered person to carry out any 
                obligation or responsibility assumed by such 
                person under a contract with the United States 
                or from any grossly negligent, reckless, or 
                illegal conduct or willful misconduct on the 
                part of such person.
                    (B) Venue.--The United States may maintain 
                an action under this paragraph against such 
                person in the district court of the United 
                States in which such person resides or has its 
                principal place of business.
            (7) Definitions.--As used in this subsection, terms 
        have the following meanings:
                    (A) Covered countermeasure.--The term 
                ``covered countermeasure'' or ``covered 
                countermeasure against smallpox'', means a 
                substance that is--
                            (i)(I) used to prevent or treat 
                        smallpox (including the vaccinia or 
                        another vaccine); or
                                    (II) \1\ used to control or 
                                treat the adverse effects of 
                                vaccinia inoculation or of 
                                administration of another 
                                covered countermeasure; and
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    \1\ Indentation is so in law. See section 3(e) of Public Law 108-20 
(117 Stat. 647).
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                            (ii) specified in a declaration 
                        under paragraph (2).
                    (B) Covered person.--The term ``covered 
                person'', when used with respect to the 
                administration of a covered countermeasure, 
                means a person who is--
                            (i) a manufacturer or distributor 
                        of such countermeasure;
                            (ii) a health care entity under 
                        whose auspices \2\--
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    \2\ Clause (ii) is shown according to the probable intent of the 
Congress. In amending the clause to create a subclause (I), section 
3(f)(2)(B) of Public Law 108-20 (117 Stat. 647) provided that the 
clause is amended by redesignating certain words ``as clause (I) and 
indenting accordingly''. The reference in the amendatory instructions 
to ``clause (I)'' probably should be to ``subclause (I)'', and the use 
in the instructions of the word ``accordingly'' requires the exercise 
of editorial judgment.
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                                    (I) such countermeasure was 
                                administered;
                                    (II) a determination was 
                                made as to whether, or under 
                                what circumstances, an 
                                individual should receive a 
                                covered countermeasure;
                                    (III) the immediate site of 
                                administration on the body of a 
                                covered countermeasure was 
                                monitored, managed, or cared 
                                for; or
                                    (IV) an evaluation was made 
                                of whether the administration 
                                of a countermeasure was 
                                effective;
                            (iii) a qualified person who 
                        administered such countermeasure;
                            (iv) a State, a political 
                        subdivision of a State, or an agency or 
                        official of a State or of such a 
                        political subdivision, if such State, 
                        subdivision, agency, or official has 
                        established requirements, provided 
                        policy guidance, supplied technical or 
                        scientific advice or assistance, or 
                        otherwise supervised or administered a 
                        program with respect to administration 
                        of such countermeasures;
                            (v) in the case of a claim arising 
                        out of alleged transmission of vaccinia 
                        from an individual--
                                    (I) the individual who 
                                allegedly transmitted the 
                                vaccinia, if vaccinia vaccine 
                                was administered to such 
                                individual as provided by 
                                paragraph (2)(B) and such 
                                individual was within a 
                                category of individuals covered 
                                by a declaration under 
                                paragraph (2)(A)(i); or
                                    (II) an entity that employs 
                                an individual described by 
                                clause (I) or where such 
                                individual has privileges or is 
                                otherwise authorized to provide 
                                health care;
                            (vi) an official, agent, or 
                        employee of a person described in 
                        clause (i), (ii), (iii), or (iv);
                            (vii) a contractor of, or a 
                        volunteer working for, a person 
                        described in clause (i), (ii), or (iv), 
                        if the contractor or volunteer performs 
                        a function for which a person described 
                        in clause (i), (ii), or (iv) is a 
                        covered person; or
                            (viii) an individual who has 
                        privileges or is otherwise authorized 
                        to provide health care under the 
                        auspices of an entity described in 
                        clause (ii) or (v)(II).
                    (C) Qualified person.--The term ``qualified 
                person'', when used with respect to the 
                administration of a covered countermeasure, 
                means a licensed health professional or other 
                individual who \1\--
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    \1\ Subparagraph (C) is shown according to the probable intent of 
the Congress. In amending the subparagraph to create a clause (i), 
section 3(g) of Public Law 108-20 (117 Stat. 648) provided that the 
subparagraph is amended by redesignating certain words ``as clause (i) 
and indenting accordingly''. The use in the amendatory instructions of 
the word ``accordingly'' requires the exercise of editorial judgment.
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                            (i) is authorized to administer 
                        such countermeasure under the law of 
                        the State in which the countermeasure 
                        was administered; or
                            (ii) is otherwise authorized by the 
                        Secretary to administer such 
                        countermeasure.
                    (D) Arising out of administration of a 
                covered countermeasure.--The term ``arising out 
                of administration of a covered 
                countermeasure'', when used with respect to a 
                claim or liability, includes a claim or 
                liability arising out of--
                            (i) determining whether, or under 
                        what conditions, an individual should 
                        receive a covered countermeasure;
                            (ii) obtaining informed consent of 
                        an individual to the administration of 
                        a covered countermeasure;
                            (iii) monitoring, management, or 
                        care of an immediate site of 
                        administration on the body of a covered 
                        countermeasure, or evaluation of 
                        whether the administration of the 
                        countermeasure has been effective; or
                            (iv) transmission of vaccinia virus 
                        by an individual to whom vaccinia 
                        vaccine was administered as provided by 
                        paragraph (2)(B).

        administration of grants in certain multigrant projects

    Sec. 226. \2\ [235] For the purpose of facilitating the 
administration of, and expediting the carrying out of the 
purposes of, the programs established by titles VII, VIII, and 
IX, and sections 304, 314(a), 314(b), 314(c), 314(d), and 
314(e) of this Act in situations in which grants are sought or 
made under two or more of such programs with respect to a 
single project, the Secretary is authorized to promulgate 
regulations--
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    \2\ Former section 225 was repealed by section 408(b)(1) of Public 
Law 94-484 (90 Stat. 2281). Subpart III of part D of title III now 
applies to the matter with which former section 225 was concerned.
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            (1) under which the administrative functions under 
        such programs with respect to such project will be 
        performed by a single administrative unit which is the 
        administrative unit charged with the administration of 
        any of such programs or is the administrative unit 
        charged with the supervision of two or more of such 
        programs;
            (2) designed to reduce the number of applications, 
        reports, and other materials required under such 
        programs to be submitted with respect to such project, 
        and otherwise to simplify, consolidate, and make 
        uniform (to the extent feasible), the data and 
        information required to be contained in such 
        applications, reports, and other materials; and
            (3) under which inconsistent or duplicative 
        requirements imposed by such programs will be revised 
        and made uniform with respect to such project;
except that nothing in this section shall be construed to 
authorize the Secretary to waive or suspend, with respect to 
any such project, any requirement with respect to any of such 
programs if such requirement is imposed by law or by any 
regulation required by law.

                         orphan products board

    Sec. 227. [236] (a) There is established in the Department 
of Health and Human Services a board for the development of 
drugs (including biologics) and devices (including diagnostic 
products) for rare diseases or conditions to be known as the 
Orphan Products Board. The Board shall be comprised of the 
Assistant Secretary for Health of the Department of Health and 
Human Services and representatives, selected by the Secretary, 
of the Food and Drug Administration, the National Institutes of 
Health, the Centers for Disease Control and Prevention, and any 
other Federal department or agency which the Secretary 
determines has activities relating to drugs and devices for 
rare diseases or conditions. The Assistant Secretary for Health 
shall chair the Board.
    (b) The function of the Board shall be to promote the 
development of drugs and devices for rare diseases or 
conditions and the coordination among Federal, other public, 
and private agencies in carrying out their respective functions 
relating to the development of such articles, such diseases or 
conditions.
    (c) In the case of drugs for rare diseases or conditions 
the Board shall--
            (1) evaluate--
                    (A) the effect of subchapter B of the 
                Federal Food, Drug, and Cosmetic Act on the 
                development of such drugs, and
                    (B) the implementation of such subchapter; 
                \1\
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    \1\ So in law. The semicolon probably should be a comma.
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            (2) evaluate the activities of the National 
        Institutes of Health for the development of drugs for 
        such diseases or conditions,
            (3) assure appropriate coordination among the Food 
        and Drug Administration, the National Institutes of 
        Health and the Centers for Disease Control and 
        Prevention in the carrying out of their respective 
        functions relating to the development of drugs for such 
        diseases or conditions to assure that the activities of 
        each agency are complementary.
            (4) assure appropriate coordination among all 
        interested Federal agencies, manufacturers, and 
        organizations representing patients, in their 
        activities relating to such drugs,
            (5) with the consent of the sponsor of a drug for a 
        rare disease or condition exempt under section 505(i) 
        of the Federal Food, Drug, and Cosmetic Act or 
        regulations issued under such section, inform 
        physicians and the public respecting the availability 
        of such drug for such disease or condition and inform 
        physicians and the public respecting the availability 
        of drugs approved under section 505(c) of such Act or 
        licensed under section 351 of this Act for rare 
        diseases or conditions,
            (6) seek business entities and others to undertake 
        the sponsorship of drugs for rare diseases or 
        conditions, seek investigators to facilitate the 
        development of such drugs, and seek business entities 
        to participate in the distribution of such drugs, and
            (7) recognize the efforts of public and private 
        entities and individuals in seeking the development of 
        drugs for rare diseases or conditions and in developing 
        such drugs.
    (d) The Board shall consult with interested persons 
respecting the activities of the Board under this section and 
as part of such consultation shall provide the opportunity for 
the submission of oral views.
    (e) The Board shall submit to the Committee on Labor and 
Human Resources of the Senate and the Committee on Energy and 
Commerce of the House of Representatives an annual report--
            (1) identifying the drugs which have been 
        designated under section 526 of the Federal Food, Drug, 
        and Cosmetic Act for a rare disease or condition,
            (2) describing the activities of the Board, and
            (3) containing the results of the evaluations 
        carried out by the Board.
The Director of the National Institutes of Health shall submit 
to the Board for inclusion in the annual report a report on the 
rare disease and condition research activities of the 
Institutes of the National Institutes of Health; the Secretary 
of the Treasury shall submit to the Board for inclusion in the 
annual report a report on the use of the credit against tax 
provided by section 44H of the Internal Revenue Code of 1954; 
and the Secretary of Health and Human Services shall submit to 
the Board for inclusion in the annual report a report on the 
program of assistance under section 5 of the Orphan Drug Act 
for the development of drugs for rare diseases and conditions. 
Each annual report shall be submitted by June 1 of each year 
for the preceding calendar year.
           silvio o. conte senior biomedical research service
    Sec. 228. [237] (a)(1) There shall be in the Public Health 
Service a Silvio O. Conte Senior Biomedical Research Service, 
not to exceed 500 members.
    (2) The authority established in paragraph (1) regarding 
the number of members in the Silvio O. Conte Senior Biomedical 
Research Service is in addition to any authority established 
regarding the number of members in the commissioned Regular 
Corps, in the Reserve Corps, and in the Senior Executive 
Service. Such paragraph may not be construed to require that 
the number of members in the commissioned Regular Corps, in the 
Reserve Corps, or in the Senior Executive Service be reduced to 
offset the number of members serving in the Silvio O. Conte 
Senior Biomedical Research Service (in this section referred to 
as the ``Service'').
    (b) The Service shall be appointed by the Secretary without 
regard to the provisions of title 5, United States Code, 
regarding appointment, and shall consist of individuals 
outstanding in the field of biomedical research or clinical 
research evaluation. No individual may be appointed to the 
Service unless such individual (1) has earned a doctoral level 
degree in biomedicine or a related field, and (2) meets the 
qualification standards prescribed by the Office of Personnel 
Management for appointment to a position at GS-15 of the 
General Schedule. Notwithstanding any previous applicability to 
an individual who is a member of the Service, the provisions of 
subchapter I of chapter 35 (relating to retention preference), 
chapter 43 (relating to performance appraisal and performance 
actions), chapter 51 (relating to classification), subchapter 
III of chapter 53 (relating to General Schedule pay rates), and 
chapter 75 (relating to adverse actions) of title 5, United 
States Code, shall not apply to any member of the Service.
    (c) The Secretary shall develop a performance appraisal 
system designed to--
            (1) provide for the systematic appraisal of the 
        performance of members, and
            (2) encourage excellence in performance by members.
    (d)(1) The Secretary shall determine, subject to the 
provisions of this subsection, the pay of members of the 
Service.
    (2) The pay of a member of the Service shall not be less 
than the minimum rate payable for GS-15 of the General Schedule 
and shall not exceed the rate payable for level I of the 
Executive Schedule unless approved by the President under 
section 5377(d)(2) of title 5, United States Code.
    (e) The Secretary may, upon the request of a member who--
            (1) performed service in the employ of an 
        institution of higher education immediately prior to 
        his appointment as a member of the Service, and
            (2) retains the right to continue to make 
        contributions to the retirement system of such 
        institution,
contribute an amount not to exceed 10 percent per annum of the 
member's basic pay to such institution's retirement system on 
behalf of such member. A member who requests that such 
contribution be made shall not be covered by, or earn service 
credit under, any retirement system established for employees 
of the United States under title 5, United States Code, but 
such service shall be creditable for determining years of 
service under section 6303(a) of such title.
    (f) Subject to the following sentence, the Secretary may, 
notwithstanding the provisions of title 5, United States Code, 
regarding appointment, appoint an individual who is separated 
from the Service involuntarily and without cause to a position 
in the competitive civil service at GS-15 of the General 
Schedule, and such appointment shall be a career appointment. 
In the case of such an individual who immediately prior to his 
appointment to the Service was not a career appointee in the 
civil service or the Senior Executive Service, such appointment 
shall be in the excepted civil service and may not exceed a 
period of 2 years.
    (g) The Secretary shall promulgate such rules and 
regulations, not inconsistent with this section, as may be 
necessary for the efficient administration of the Service.

SEC. 229. \1\ [237A] HEALTH AND HUMAN SERVICES OFFICE ON WOMEN'S 
                    HEALTH.
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    \1\ Section 3509 of the Patient Protection and Affordable Care Act 
(Public Law 111-148, enacted March 23, 2010) established offices of 
womens health in the Office of the Secretary of HHS (this section), the 
Centers for Disease Control and Prevention (section 310A of this Act), 
the Agency for Healthcare Research and Quality (section 925 of this 
Act), the Health Resources and Services Administration (section 713 of 
the Social Security Act), and the Food and Drug Administration (section 
1011 of the Federal Food, Drug, and Cosmetic Act).
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    (a) Establishment of Office.--There is established within 
the Office of the Secretary, an Office on Women's Health 
(referred to in this section as the ``Office''). The Office 
shall be headed by a Deputy Assistant Secretary for Women's 
Health who may report to the Secretary.
    (b) Duties.--The Secretary, acting through the Office, with 
respect to the health concerns of women, shall--
            (1) establish short-range and long-range goals and 
        objectives within the Department of Health and Human 
        Services and, as relevant and appropriate, coordinate 
        with other appropriate offices on activities within the 
        Department that relate to disease prevention, health 
        promotion, service delivery, research, and public and 
        health care professional education, for issues of 
        particular concern to women throughout their lifespan;
            (2) provide expert advice and consultation to the 
        Secretary concerning scientific, legal, ethical, and 
        policy issues relating to women's health;
            (3) monitor the Department of Health and Human 
        Services' offices, agencies, and regional activities 
        regarding women's health and identify needs regarding 
        the coordination of activities, including intramural 
        and extramural multidisciplinary activities;
            (4) establish a Department of Health and Human 
        Services Coordinating Committee on Women's Health, 
        which shall be chaired by the Deputy Assistant 
        Secretary for Women's Health and composed of senior 
        level representatives from each of the agencies and 
        offices of the Department of Health and Human Services;
            (5) establish a National Women's Health Information 
        Center to--
                    (A) facilitate the exchange of information 
                regarding matters relating to health 
                information, health promotion, preventive 
                health services, research advances, and 
                education in the appropriate use of health 
                care;
                    (B) facilitate access to such information;
                    (C) assist in the analysis of issues and 
                problems relating to the matters described in 
                this paragraph; and
                    (D) provide technical assistance with 
                respect to the exchange of information 
                (including facilitating the development of 
                materials for such technical assistance);
            (6) coordinate efforts to promote women's health 
        programs and policies with the private sector; and
            (7) through publications and any other means 
        appropriate, provide for the exchange of information 
        between the Office and recipients of grants, contracts, 
        and agreements under subsection (c), and between the 
        Office and health professionals and the general public.
    (c) Grants and Contracts Regarding Duties.--
            (1) Authority.--In carrying out subsection (b), the 
        Secretary may make grants to, and enter into 
        cooperative agreements, contracts, and interagency 
        agreements with, public and private entities, agencies, 
        and organizations.
            (2) Evaluation and dissemination.--The Secretary 
        shall directly or through contracts with public and 
        private entities, agencies, and organizations, provide 
        for evaluations of projects carried out with financial 
        assistance provided under paragraph (1) and for the 
        dissemination of information developed as a result of 
        such projects.
    (d) Reports.--Not later than 1 year after the date of 
enactment of this section, and every second year thereafter, 
the Secretary shall prepare and submit to the appropriate 
committees of Congress a report describing the activities 
carried out under this section during the period for which the 
report is being prepared.
    (e) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2010 through 2014.

                    Part B--Miscellaneous Provisions

                                 gifts
    Sec. 231. [238] (a) The Secretary is authorized to accept 
on behalf of the United States gifts made unconditionally by 
will or otherwise for the benefit of the Service or for the 
carrying out of any of its functions. Conditional gifts may be 
so accepted if recommended by the Surgeon General, and the 
principal of and income from any such conditional gift shall be 
held, invested, reinvested, and used in accordance with its 
conditions, but no gift shall be accepted which is conditioned 
upon any expenditure not to be met therefrom or from the income 
thereof unless such expenditure has been approved by Act of 
Congress.
    (b) Any unconditional gift of money accepted, pursuant to 
the authority granted in subsection (a) of this section, the 
net proceeds from the liquidation (pursuant to subsection (c) 
or subsection (d) of this section) of any other property so 
accepted, and the proceeds of insurance on any such gift 
property not used for its restoration, shall be deposited in 
the Treasury of the United States and are hereby appropriated 
and shall be held in trust by the Secretary of the Treasury for 
the benefit of the Service, and he may invest and reinvest such 
funds in interest-bearing obligations of the United States or 
in obligations guaranteed as to both principal and interest by 
the United States. Such gifts and the income from such 
investments shall be available for expenditure in the operation 
of the Service and the performance of its functions, subject to 
the same examination and audit as is provided for 
appropriations made for the Service by Congress.
    (c) The evidences of any unconditional gift of intangible 
personal property, other than money, accepted pursuant to the 
authority granted in subsection (a) of this section shall be 
deposited with the Secretary of the Treasury and he, in his 
discretion, may hold them, or liquidate them except that they 
shall be liquidated upon the request of the Secretary, whenever 
necessary to meet payments required in the operation of the 
Service or the performance of its functions. The proceeds and 
income from any such property held by the Secretary of the 
Treasury shall be available for expenditure as is provided in 
subsection (b) of this section.
    (d) The Secretary shall hold any real property or any 
tangible personal property accepted unconditionally pursuant to 
the authority granted in subsection (a) of this section and he 
shall permit such property to be used for the operation of the 
Service and the performance of its functions or he may lease or 
hire such property, and may insure such property, and deposit 
the income thereof with the Secretary of the Treasury to be 
available for expenditure as provided in subsection (b) of this 
section: Provided, That the income from any such real property 
or tangible personal property shall be available for 
expenditure in the discretion of the Secretary for the 
maintenance, preservation, or repair and insurance of such 
property and that any proceeds from insurance may be used to 
restore the property insured. Any such property when not 
required for the operation of the Service or the performance of 
its functions may be liquidated by the Secretary, and the 
proceeds thereof deposited with the Secretary of the Treasury, 
whenever in his judgment the purposes of the gifts will be 
served thereby.

                  use of immigration station hospitals

    Sec. 232. [238a] The Immigration and Naturalization Service 
may, by agreement of the heads of the departments concerned, 
permit the Public Health Service to use hospitals at 
immigration stations for the care of Public Health Service 
patients. The Surgeon General shall reimburse the Immigration 
and Naturalization Service for the actual cost of furnishing 
fuel, light, water, telephone, and similar supplies and 
services, which reimbursement shall be covered into the proper 
Immigration and Naturalization Service appropriation, or such 
costs may be paid from working funds established as provided by 
law, but no charge shall be made for the expense of physical 
upkeep of the hospitals. The Immigration and Naturalization 
Service shall reimburse the Surgeon General for the care and 
treatment of persons detained in hospitals of the Public Health 
Service at the request of the Immigration and Naturalization 
Service unless such persons are entitled to care and treatment 
under section 322(a). \1\
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    \1\ Subsection (a) of section 322 was repealed by section 986 of 
Public Law 97-35, and the Public Law redesignated former subsection (c) 
as subsection (a). Section 232 (above) was enacted before this repeal 
and redesignation. Current section 322(a) authorizes the treatment and 
care of certain persons. (Section 232 was originally enacted as section 
502, and was subsequently redesignated by Public Laws 98-24, 99-660, 
100-690, and 103-43.)
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                  money collected for care of patients

    Sec. 233. [238b] Money collected as provided by law for 
expenses incurred in the care and treatment of foreign seamen, 
and money received for the care and treatment of pay patients, 
including any amounts received from any executive department on 
account of care and treatment of pay patients, shall be covered 
into the appropriation from which the expenses of such care and 
treatment were paid.

                 transportation of remains of officers

    Sec. 234. [238c] Appropriations available for traveling 
expenses of the Service shall be available for meeting the cost 
of preparation for burial and of transportation to the place of 
burial of remains of commissioned officers, and of personnel 
specified in regulations, who die in line of duty. 
Appropriations available for carrying out the provisions of 
this Act shall also be available for the payment of such 
expenses relating to the recovery, care, and disposition of the 
remains of personnel or their dependents as may be authorized 
under other provisions of law.

                     grants to federal institutions

    Sec. 235. [238d] Appropriations to the Public Health 
Service available under this Act for research, training, or 
demonstration project grants or for grants to expand existing 
treatment and research programs and facilities for alcoholism, 
narcotic addiction, drug abuse, and drug dependence and 
appropriations under title VI of the Mental Health Systems Act 
shall also be available, on the same terms and conditions as 
apply to non-Federal institutions, for grants for the same 
purpose to Federal institutions, except that grants to such 
Federal institutions may be funded at 100 per centum of the 
costs.

                           transfer of funds

    Sec. 236. [238e] For the purpose of any reorganization 
under section 202, the Secretary, with the approval of the 
Director of the Bureau of the Budget, \1\ is authorized to make 
such transfers of funds between appropriations as may be 
necessary for the continuance of transferred functions.
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    \1\ Now the Office of Management and Budget.
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                     availability of appropriations

    Sec. 237. [238f] Appropriations for carrying out the 
purposes of this Act shall be available for expenditure for 
personal services and rent at the seat of Government; books of 
reference, periodicals, and exhibits; printing and binding; 
transporting in Government-owned automotive equipment, to and 
from school, children of personnel who have quarters for 
themselves and their families at stations determined by the 
Surgeon General to be isolated stations; expenses incurred in 
pursuing, identifying, and returning prisoners who escape from 
any hospital, institution, or station of the Service or from 
the custody of any officer or employee of the Service, 
including rewards for the capture of such prisoners; 
furnishing, repairing, and cleaning such wearing apparel as may 
be prescribed by the Surgeon General for use by employees in 
the performance of their official duties; reimbursing officers 
and employees, subject to regulations of the Secretary, for the 
cost of repairing or replacing their personal belongings 
damaged or destroyed by patients while such officers or 
employees are engaged in the performance of their official 
duties; and maintenance of buildings of the National Institutes 
of Health.

                    unauthorized wearing of uniforms

    Sec. 238. [238g] Except as may be authorized by regulations 
of the President, the insignia and uniform of commissioned 
officers of the Service, or any distinctive part of such 
insignia or uniform, or any insignia or uniform any part of 
which is similar to a distinctive part thereof, shall not be 
worn, after the promulgation of such regulations, by any person 
other than a commissioned officer of the Service.
                            biannual report
    Sec. 239. [238h] The Surgeon General shall transmit to the 
Secretary, for submission to the Congress, on January 1, 1995, 
and on January 1, every 2 years thereafter, a full report of 
the administration of the functions of the Service under this 
Act, including a detailed statement of receipts and 
disbursements.

                  memorials and other acknowledgments

    Sec. 240. [238i] The Secretary may provide for suitably 
acknowledging, within the Department (whether by memorials, 
designations, or other suitable acknowledgments), (1) efforts 
of persons who have contributed substantially to the health of 
the Nation and (2) gifts for use in activities of the 
Department related to health.
                         evaluation of programs
    Sec. 241. [238j] (a) In General.--Such portion as the 
Secretary shall determine, but not less than 0.2 percent nor 
more than 1 percent, of any amounts appropriated for programs 
authorized under this Act shall be made available for the 
evaluation (directly, or by grants of contracts) of the 
implementation and effectiveness of such programs.
    (b) Report on Evaluations.--Not later than February 1 of 
each year, the Secretary shall prepare and submit to the 
Committee on Labor and Human Resources of the Senate and the 
Committee on Energy and Commerce of the House of 
Representatives a report summarizing the findings of the 
evaluations conducted under subsection (a).

                           contract authority

    Sec. 242. [238k] The authority of the Secretary to enter 
into contracts under this Act shall be effective for any fiscal 
year only to such extent or in such amounts as are provided in 
advance by appropriation Acts.

                                recovery

      Sec. 243. [238l] (a) If any facility with respect to 
which funds have been paid under the Community Mental Health 
Centers Act (as such Act was in effect prior to October 1, 
1981) is, at any time within twenty years after the completion 
of remodeling, construction, or expansion or after the date of 
its acquisition--
            (1) sold or transferred to any entity (A) which 
        would not have been qualified to file an application 
        under section 222 of such Act (as such section was in 
        effect prior to October 1, 1981) or (B) which is 
        disapproved as a transferee by the State mental health 
        agency or by another entity designated by the chief 
        executive officer of the State, or
            (2) ceases to be used by a community mental health 
        center in the provision of comprehensive mental health 
        services,
the United States shall be entitled to recover from the 
transferor, transferee, or owner of the facility, the base 
amount prescribed by subsection (c)(1) plus the interest (if 
any) prescribed by subsection (c)(2).
      (b) The transferor and transferee of a facility that is 
sold or transferred as described in subsection (a)(1), or the 
owner of a facility the use of which changes as described in 
subsection (a)(2), shall provide the Secretary written notice 
of such sale, transfer, or change within 10 days after the date 
on which such sale, transfer, or cessation of use occurs or 
within 30 days after the date of enactment of this subsection, 
whichever is later.
      (c)(1) The base amount that the United States is entitled 
to recover under subsection (a) is the amount bearing the same 
ratio to the then value (as determined by the agreement of the 
parties or in an action brought in the district court of the 
United States for the district in which the facility is 
situated) of so much of the facility as constituted an approved 
project or projects as the amount of the Federal participation 
bore to the cost of the remodeling, construction, expansion, or 
acquisition of the project or projects.
      (2)(A) The interest that the United States is entitled to 
recover under subsection (a) is the interest for the period (if 
any) described in subparagraph (B) at a rate (determined by the 
Secretary) based on the average of the bond equivalent rates of 
ninety-one-day Treasury bills auctioned during that period.
      (B) The period referred to in subparagraph (A) is the 
period beginning--
            (i) if notice is provided as prescribed by 
        subsection (b), 191 days after the date on which such 
        sale, transfer, or cessation of use occurs, or
            (ii) if notice is not provided as prescribed by 
        subsection (b), 11 days after such sale, transfer, or 
        cessation of use occurs,
and ending on the date the amount the United States is entitled 
to recover is collected.
      (d) The Secretary may waive the recovery rights of the 
United States under subsection (a) with respect to a facility 
(under such conditions as the Secretary may establish by 
regulation) if the Secretary determines that there is good 
cause for waiving such rights.
      (e) The right of recovery of the United States under 
subsection (a) shall not, prior to judgment, constitute a lien 
on any facility.
                          use of fiscal agents
    Sec. 244. [238m] (a) The Secretary may enter into contracts 
with fiscal agents--
            (1)(A) to determine the amounts payable to persons 
        who, on behalf of the Indian Health Service, furnish 
        health services to eligible Indians,
            (B) to determine the amounts payable to persons 
        who, on behalf of the Public Health Service, furnish 
        health services to individuals pursuant to section 319 
        or 322,
            (2) to receive, disburse, and account for funds in 
        making payments described in paragraph (1),
            (3) to make such audits of records as may be 
        necessary to assure that these payments are proper, and
            (4) to perform such additional functions as may be 
        necessary to carry out the functions described in 
        paragraphs (1) through (3).
    (b)(1) Contracts under subsection (a) may be entered into 
without regard to section 3709 of the Revised Statutes (41 
U.S.C. 5) or any other provision of law requiring competition.
    (2) No such contract shall be entered into with an entity 
unless the Secretary finds that the entity will perform its 
obligations under the contract efficiently and effectively and 
will meet such requirements as to financial responsibility, 
legal authority, and other matters as he finds pertinent.
    (c) A contract under subsection (a) may provide for 
advances of funds to enable entities to make payments under the 
contract.
    (d) Subsections (d) and (e) of section 1842 of the Social 
Security Act shall apply to contracts with entities under 
subsection (a) in the same manner as they apply to contracts 
with carriers under that section.
    (e) In this section, the term ``fiscal agent'' means a 
carrier described in section 1842(f)(1) of the Social Security 
Act and includes, with respect to contracts under subsection 
(a)(1)(A), an Indian tribe or tribal organization acting under 
contract with the Secretary under the Indian Self-Determination 
Act (Public Law 93-638).
 abortion-related discrimination in governmental activities regarding 
                  training and licensing of physicians
      Sec. 245. [238n] (a) In General.--The Federal Government, 
and any State or local government that receives Federal 
financial assistance, may not subject any health care entity to 
discrimination on the basis that--
            (1) the entity refuses to undergo training in the 
        performance of induced abortions, to require or provide 
        such training, to perform such abortions, or to provide 
        referrals for such training or such abortions;
            (2) the entity refuses to make arrangements for any 
        of the activities specified in paragraph (1); or
            (3) the entity attends (or attended) a post-
        graduate physician training program, or any other 
        program of training in the health professions, that 
        does not (or did not) perform induced abortions or 
        require, provide or refer for training in the 
        performance of induced abortions, or make arrangements 
        for the provision of such training.
      (b) Accreditation of Postgraduate Physician Training 
Programs.--
            (1) In general.--In determining whether to grant a 
        legal status to a health care entity (including a 
        license or certificate), or to provide such entity with 
        financial assistance, services or other benefits, the 
        Federal Government, or any State or local government 
        that receives Federal financial assistance, shall deem 
        accredited any postgraduate physician training program 
        that would be accredited but for the accrediting 
        agency's reliance upon an accreditation standard that 
        requires an entity to perform an induced abortion or 
        require, provide, or refer for training in the 
        performance of induced abortions, or make arrangements 
        for such training, regardless of whether such standard 
        provides exceptions or exemptions. The government 
        involved shall formulate such regulations or other 
        mechanisms, or enter into such agreements with 
        accrediting agencies, as are necessary to comply with 
        this subsection.
            (2) Rules of construction.--
                    (A) In general.--With respect to subclauses 
                (I) and (II) of section 705(a)(2)(B)(i) 
                (relating to a program of insured loans for 
                training in the health professions), the 
                requirements in such subclauses regarding 
                accredited internship or residency programs are 
                subject to paragraph (1) of this subsection.
                    (B) Exceptions.--This section shall not--
                            (i) prevent any health care entity 
                        from voluntarily electing to be 
                        trained, to train, or to arrange for 
                        training in the performance of, to 
                        perform, or to make referrals for 
                        induced abortions; or
                            (ii) prevent an accrediting agency 
                        or a Federal, State or local government 
                        from establishing standards of medical 
                        competency applicable only to those 
                        individuals who have voluntarily 
                        elected to perform abortions.
      (c) Definitions.--For purposes of this section:
            (1) The term ``financial assistance'', with respect 
        to a government program, includes governmental payments 
        provided as reimbursement for carrying out health-
        related activities.
            (2) The term ``health care entity'' includes an 
        individual physician, a postgraduate physician training 
        program, and a participant in a program of training in 
        the health professions.
            (3) The term ``postgraduate physician training 
        program'' includes a residency training program.

SEC. 246. [238O] RESTRICTION ON USE OF FUNDS FOR ASSISTED SUICIDE, 
                    EUTHANASIA, AND MERCY KILLING.

    Appropriations for carrying out the purposes of this Act 
shall not be used in a manner inconsistent with the Assisted 
Suicide Funding Restriction Act of 1997. \1\
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    \1\ Public Law 105-12 (111 Stat. 23).
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      recommendations and guidelines regarding automated external 
                  defibrillators for federal buildings
    Sec. 247. [238p] (a) Guidelines on Placement.--The 
Secretary shall establish guidelines with respect to placing 
automated external defibrillator devices in Federal buildings. 
Such guidelines shall take into account the extent to which 
such devices may be used by lay persons, the typical number of 
employees and visitors in the buildings, the extent of the need 
for security measures regarding the buildings, buildings or 
portions of buildings in which there are special circumstances 
such as high electrical voltage or extreme heat or cold, and 
such other factors as the Secretary determines to be 
appropriate.
    (b) Related Recommendations.--The Secretary shall publish 
in the Federal Register the recommendations of the Secretary on 
the appropriate implementation of the placement of automated 
external defibrillator devices under subsection (a), including 
procedures for the following:
            (1) Implementing appropriate training courses in 
        the use of such devices, including the role of 
        cardiopulmonary resuscitation.
            (2) Proper maintenance and testing of the devices.
            (3) Ensuring coordination with appropriate licensed 
        professionals in the oversight of training of the 
        devices.
            (4) Ensuring coordination with local emergency 
        medical systems regarding the placement and incidents 
        of use of the devices.
    (c) Consultations; Consideration of Certain 
Recommendations.--In carrying out this section, the Secretary 
shall--
            (1) consult with appropriate public and private 
        entities;
            (2) consider the recommendations of national and 
        local public-health organizations for improving the 
        survival rates of individuals who experience cardiac 
        arrest in nonhospital settings by minimizing the time 
        elapsing between the onset of cardiac arrest and the 
        initial medical response, including defibrillation as 
        necessary; and
            (3) consult with and counsel other Federal agencies 
        where such devices are to be used.
    (d) Date Certain for Establishing Guidelines and 
Recommendations.--The Secretary shall comply with this section 
not later than 180 days after the date of the enactment of the 
Cardiac Arrest Survival Act of 2000.
    (e) Definitions.--For purposes of this section:
            (1) The term ``automated external defibrillator 
        device'' has the meaning given such term in section 
        248.
            (2) The term ``Federal building'' includes a 
        building or portion of a building leased or rented by a 
        Federal agency, and includes buildings on military 
        installations of the United States.
 liability regarding emergency use of automated external defibrillators
    Sec. 248. [238q] (a) Good Samaritan Protections Regarding 
AEDs.--Except as provided in subsection (b), any person who 
uses or attempts to use an automated external defibrillator 
device on a victim of a perceived medical emergency is immune 
from civil liability for any harm resulting from the use or 
attempted use of such device; and in addition, any person who 
acquired the device is immune from such liability, if the harm 
was not due to the failure of such acquirer of the device--
            (1) to notify local emergency response personnel or 
        other appropriate entities of the most recent placement 
        of the device within a reasonable period of time after 
        the device was placed;
            (2) to properly maintain and test the device; or
            (3) to provide appropriate training in the use of 
        the device to an employee or agent of the acquirer when 
        the employee or agent was the person who used the 
        device on the victim, except that such requirement of 
        training does not apply if--
                    (A) the employee or agent was not an 
                employee or agent who would have been 
                reasonably expected to use the device; or
                    (B) the period of time elapsing between the 
                engagement of the person as an employee or 
                agent and the occurrence of the harm (or 
                between the acquisition of the device and the 
                occurrence of the harm, in any case in which 
                the device was acquired after such engagement 
                of the person) was not a reasonably sufficient 
                period in which to provide the training.
    (b) Inapplicability of Immunity.--Immunity under subsection 
(a) does not apply to a person if--
            (1) the harm involved was caused by willful or 
        criminal misconduct, gross negligence, reckless 
        misconduct, or a conscious, flagrant indifference to 
        the rights or safety of the victim who was harmed;
            (2) the person is a licensed or certified health 
        professional who used the automated external 
        defibrillator device while acting within the scope of 
        the license or certification of the professional and 
        within the scope of the employment or agency of the 
        professional;
            (3) the person is a hospital, clinic, or other 
        entity whose purpose is providing health care directly 
        to patients, and the harm was caused by an employee or 
        agent of the entity who used the device while acting 
        within the scope of the employment or agency of the 
        employee or agent; or
            (4) the person is an acquirer of the device who 
        leased the device to a health care entity (or who 
        otherwise provided the device to such entity for 
        compensation without selling the device to the entity), 
        and the harm was caused by an employee or agent of the 
        entity who used the device while acting within the 
        scope of the employment or agency of the employee or 
        agent.
    (c) Rules of Construction.--
            (1) In general.--The following applies with respect 
        to this section:
                    (A) This section does not establish any 
                cause of action, or require that an automated 
                external defibrillator device be placed at any 
                building or other location.
                    (B) With respect to a class of persons for 
                which this section provides immunity from civil 
                liability, this section supersedes the law of a 
                State only to the extent that the State has no 
                statute or regulations that provide persons in 
                such class with immunity for civil liability 
                arising from the use by such persons of 
                automated external defibrillator devices in 
                emergency situations (within the meaning of the 
                State law or regulation involved).
                    (C) This section does not waive any 
                protection from liability for Federal officers 
                or employees under--
                            (i) section 224; or
                            (ii) sections 1346(b), 2672, and 
                        2679 of title 28, United States Code, 
                        or under alternative benefits provided 
                        by the United States where the 
                        availability of such benefits precludes 
                        a remedy under section 1346(b) of title 
                        28.
            (2) Civil actions under federal law.--
                    (A) In general.--The applicability of 
                subsections (a) and (b) includes applicability 
                to any action for civil liability described in 
                subsection (a) that arises under Federal law.
                    (B) Federal areas adopting state law.--If a 
                geographic area is under Federal jurisdiction 
                and is located within a State but out of the 
                jurisdiction of the State, and if, pursuant to 
                Federal law, the law of the State applies in 
                such area regarding matters for which there is 
                no applicable Federal law, then an action for 
                civil liability described in subsection (a) 
                that in such area arises under the law of the 
                State is subject to subsections (a) through (c) 
                in lieu of any related State law that would 
                apply in such area in the absence of this 
                subparagraph.
    (d) Federal Jurisdiction.--In any civil action arising 
under State law, the courts of the State involved have 
jurisdiction to apply the provisions of this section exclusive 
of the jurisdiction of the courts of the United States.
    (e) Definitions.--
            (1) Perceived medical emergency.--For purposes of 
        this section, the term ``perceived medical emergency'' 
        means circumstances in which the behavior of an 
        individual leads a reasonable person to believe that 
        the individual is experiencing a life-threatening 
        medical condition that requires an immediate medical 
        response regarding the heart or other cardiopulmonary 
        functioning of the individual.
            (2) Other definitions.--For purposes of this 
        section:
                    (A) The term ``automated external 
                defibrillator device'' means a defibrillator 
                device that--
                            (i) is commercially distributed in 
                        accordance with the Federal Food, Drug, 
                        and Cosmetic Act;
                            (ii) is capable of recognizing the 
                        presence or absence of ventricular 
                        fibrillation, and is capable of 
                        determining without intervention by the 
                        user of the device whether 
                        defibrillation should be performed;
                            (iii) upon determining that 
                        defibrillation should be performed, is 
                        able to deliver an electrical shock to 
                        an individual; and
                            (iv) in the case of a defibrillator 
                        device that may be operated in either 
                        an automated or a manual mode, is set 
                        to operate in the automated mode.
                    (B)(i) The term ``harm'' includes physical, 
                nonphysical, economic, and noneconomic losses.
                    (ii) The term ``economic loss'' means any 
                pecuniary loss resulting from harm (including 
                the loss of earnings or other benefits related 
                to employment, medical expense loss, 
                replacement services loss, loss due to death, 
                burial costs, and loss of business or 
                employment opportunities) to the extent 
                recovery for such loss is allowed under 
                applicable State law.
                    (iii) The term ``noneconomic losses'' means 
                losses for physical and emotional pain, 
                suffering, inconvenience, physical impairment, 
                mental anguish, disfigurement, loss of 
                enjoyment of life, loss of society and 
                companionship, loss of consortium (other than 
                loss of domestic service), hedonic damages, 
                injury to reputation and all other nonpecuniary 
                losses of any kind or nature.

            Part C--Smallpox Emergency Personnel Protection

SEC. 261. [239] GENERAL PROVISIONS.

    (a) Definitions.--For purposes of this part:
            (1) Covered countermeasure.--The term ``covered 
        countermeasure'' means a covered countermeasure as 
        specified in a Declaration made pursuant to section 
        224(p).
            (2) Covered individual.--The term ``covered 
        individual'' means an individual--
                    (A) who is a health care worker, law 
                enforcement officer, firefighter, security 
                personnel, emergency medical personnel, other 
                public safety personnel, or support personnel 
                for such occupational specialities;
                    (B) who is or will be functioning in a role 
                identified in a State, local, or Department of 
                Health and Human Services smallpox emergency 
                response plan (as defined in paragraph (7)) 
                approved by the Secretary;
                    (C) who has volunteered and been selected 
                to be a member of a smallpox emergency response 
                plan described in subparagraph (B) prior to the 
                time at which the Secretary publicly announces 
                that an active case of smallpox has been 
                identified either within or outside of the 
                United States; and
                    (D) to whom a smallpox vaccine is 
                administered pursuant to such approved plan 
                during the effective period of the Declaration 
                (including the portion of such period before 
                the enactment of this part).
            (3) Covered injury.--The term ``covered injury'' 
        means an injury, disability, illness, condition, or 
        death (other than a minor injury such as minor scarring 
        or minor local reaction) determined, pursuant to the 
        procedures established under section 262, to have been 
        sustained by an individual as the direct result of--
                    (A) administration to the individual of a 
                covered countermeasure during the effective 
                period of the Declaration; or
                    (B) accidental vaccinia inoculation of the 
                individual in circumstances in which--
                            (i) the vaccinia is contracted 
                        during the effective period of the 
                        Declaration or within 30 days after the 
                        end of such period;
                            (ii) smallpox vaccine has not been 
                        administered to the individual; and
                            (iii) the individual has been in 
                        contact with an individual who is (or 
                        who was accidentally inoculated by) a 
                        covered individual.
            (4) Declaration.--The term ``Declaration'' means 
        the Declaration Regarding Administration of Smallpox 
        Countermeasures issued by the Secretary on January 24, 
        2003, and published in the Federal Register on January 
        28, 2003.
            (5) Effective period of the declaration.--The term 
        ``effective period of the Declaration'' means the 
        effective period specified in the Declaration, unless 
        extended by the Secretary.
            (6) Eligible individual.--The term ``eligible 
        individual'' means an individual who is (as determined 
        in accordance with section 262)--
                    (A) a covered individual who sustains a 
                covered injury in the manner described in 
                paragraph (3)(A); or
                    (B) an individual who sustains a covered 
                injury in the manner described in paragraph 
                (3)(B).
            (7) Smallpox emergency response plan.--The term 
        ``smallpox emergency response plan'' or ``plan'' means 
        a response plan detailing actions to be taken in 
        preparation for a possible smallpox-related emergency 
        during the period prior to the identification of an 
        active case of smallpox either within or outside the 
        United States.
    (b) Voluntary Program.--The Secretary shall ensure that a 
State, local, or Department of Health and Human Services plan 
to vaccinate individuals that is approved by the Secretary 
establishes procedures to ensure, consistent with the 
Declaration and any applicable guidelines of the Centers for 
Disease Control and Prevention, that--
            (1) potential participants are educated with 
        respect to contraindications, the voluntary nature of 
        the program, and the availability of potential benefits 
        and compensation under this part;
            (2) there is voluntary screening provided to 
        potential participants that can identify health 
        conditions relevant to contraindications; and
            (3) there is appropriate post-inoculation medical 
        surveillance that includes an evaluation of adverse 
        health effects that may reasonably appear to be due to 
        such vaccine and prompt referral of, or the provision 
        of appropriate information to, any individual requiring 
        health care as a result of such adverse health event.

SEC. 262. [239A] DETERMINATION OF ELIGIBILITY AND BENEFITS.

    (a) In General.--The Secretary shall establish procedures 
for determining, as applicable with respect to an individual--
            (1) whether the individual is an eligible 
        individual;
            (2) whether an eligible individual has sustained a 
        covered injury or injuries for which medical benefits 
        or compensation may be available under sections 264 and 
        265, and the amount of such benefits or compensation; 
        and
            (3) whether the covered injury or injuries of an 
        eligible individual caused the individual's death for 
        purposes of benefits under section 266.
    (b) Covered Individuals.--The Secretary may accept a 
certification, by a Federal, State, or local government entity 
or private health care entity participating in the 
administration of covered countermeasures under the 
Declaration, that an individual is a covered individual.
    (c) Criteria for Reimbursement.--
            (1) Injuries specified in injury table.--In any 
        case where an injury or other adverse effect specified 
        in the injury table established under section 263 as a 
        known effect of a vaccine manifests in an individual 
        within the time period specified in such table, such 
        injury or other effect shall be presumed to have 
        resulted from administration of such vaccine.
            (2) Other determinations.--In making determinations 
        other than those described in paragraph (1) as to the 
        causation or severity of an injury, the Secretary shall 
        employ a preponderance of the evidence standard and 
        take into consideration all relevant medical and 
        scientific evidence presented for consideration, and 
        may obtain and consider the views of qualified medical 
        experts.
    (d) Deadline for Filing Request.--The Secretary shall not 
consider any request for a benefit under this part with respect 
to an individual, unless--
            (1) in the case of a request based on the 
        administration of the vaccine to the individual, the 
        individual files with the Secretary an initial request 
        for benefits or compensation under this part not later 
        than one year after the date of administration of the 
        vaccine; or
            (2) in the case of a request based on accidental 
        vaccinia inoculation, the individual files with the 
        Secretary an initial request for benefits or 
        compensation under this part not later than two years 
        after the date of the first symptom or manifestation of 
        onset of the adverse effect.
    (e) Structured Settlements at Secretary's Option.--In any 
case in which there is a reasonable likelihood that 
compensation or payment under section 264, 265, or 266(b) will 
be required for a period in excess of one year from the date an 
individual is determined eligible for such compensation or 
payment, the Secretary shall have the discretion to make a 
lump-sum payment, purchase an annuity or medical insurance 
policy, or execute an appropriate structured settlement 
agreement, provided that such payment, annuity, policy, or 
agreement is actuarially determined to have a value equal to 
the present value of the projected total amount of benefits or 
compensation that the individual is eligible to receive under 
such section or sections.
    (f) Review of Determination.--
            (1) Secretary's review authority.--The Secretary 
        may review a determination under this section at any 
        time on the Secretary's own motion or on application, 
        and may affirm, vacate, or modify such determination in 
        any manner the Secretary deems appropriate. The 
        Secretary shall develop a process by which an 
        individual may file a request for reconsideration of 
        any determination made by the Secretary under this 
        section.
            (2) Judicial and administrative review.--No court 
        of the United States, or of any State, District, 
        territory or possession thereof, shall have subject 
        matter jurisdiction to review, whether by mandamus or 
        otherwise, any action by the Secretary under this 
        section. No officer or employee of the United States 
        shall review any action by the Secretary under this 
        section (unless the President specifically directs 
        otherwise).

SEC. 263. [239B] SMALLPOX VACCINE INJURY TABLE.

    (a) \1\ Smallpox Vaccine Injury Table.--
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    \1\ Subsection (a) designation so in law. Section 263 does not 
contain a subsection (b). See the amendment made by section 2 of Public 
Law 108-20 (117 Stat. 638, 641), which added a new part C to title II.
---------------------------------------------------------------------------
            (1) Establishment required.--The Secretary shall 
        establish by interim final regulation a table 
        identifying adverse effects (including injuries, 
        disabilities, illnesses, conditions, and deaths) that 
        shall be presumed to result from the administration of 
        (or exposure to) a smallpox vaccine, and the time 
        period in which the first symptom or manifestation of 
        onset of each such adverse effect must manifest in 
        order for such presumption to apply.
            (2) Amendments.--The Secretary may by regulation 
        amend the table established under paragraph (1). An 
        amendment to the table takes effect on the date of the 
        promulgation of the final rule that makes the 
        amendment, and applies to all requests for benefits or 
        compensation under this part that are filed on or after 
        such date or are pending as of such date. In addition, 
        the amendment applies retroactively to an individual 
        who was not with respect to the injury involved an 
        eligible individual under the table as in effect before 
        the amendment but who with respect to such injury is an 
        eligible individual under the table as amended. With 
        respect to a request for benefits or compensation under 
        this part by an individual who becomes an eligible 
        individual as described in the preceding sentence, the 
        Secretary may not provide such benefits or compensation 
        unless the request (or amendment to a request, as 
        applicable) is filed before the expiration of one year 
        after the effective date of the amendment to the table 
        in the case of an individual to whom the vaccine was 
        administered and before the expiration of two years 
        after such effective date in the case of a request 
        based on accidental vaccinia inoculation.

SEC. 264. [239C] MEDICAL BENEFITS.

    (a) In General.--Subject to the succeeding provisions of 
this section, the Secretary shall make payment or reimbursement 
for medical items and services as reasonable and necessary to 
treat a covered injury of an eligible individual, including the 
services, appliances, and supplies prescribed or recommended by 
a qualified physician, which the Secretary considers likely to 
cure, give relief, reduce the degree or the period of 
disability, or aid in lessening the amount of monthly 
compensation.
    (b) Benefits Secondary to Other Coverage.--Payment or 
reimbursement for services or benefits under subsection (a) 
shall be secondary to any obligation of the United States or 
any third party (including any State or local governmental 
entity, private insurance carrier, or employer) under any other 
provision of law or contractual agreement, to pay for or 
provide such services or benefits.

SEC. 265. [239D] COMPENSATION FOR LOST EMPLOYMENT INCOME.

    (a) In General.--Subject to the succeeding provisions of 
this section, the Secretary shall provide compensation to an 
eligible individual for loss of employment income (based on 
such income at the time of injury) incurred as a result of a 
covered injury, at the rate specified in subsection (b).
    (b) Amount of Compensation.--
            (1) In general.--Compensation under subsection (a) 
        shall be at the rate of 66\2/3\ percent of the relevant 
        pay period (weekly, monthly, or otherwise), except as 
        provided in paragraph (2).
            (2) Augmented compensation for dependents.--If an 
        eligible individual has one or more dependents, the 
        basic compensation for loss of employment income as 
        described in paragraph (1) shall be augmented at the 
        rate of 8\1/3\ percent.
            (3) Consideration of other programs.--
                    (A) In general.--The Secretary may consider 
                the provisions of sections 8114, 8115, and 
                8146a of title 5, United States Code, and any 
                implementing regulations, in determining the 
                amount of payment under subsection (a) and the 
                circumstances under which such payments are 
                reasonable and necessary.
                    (B) Minors.--With respect to an eligible 
                individual who is a minor, the Secretary may 
                consider the provisions of section 8113 of 
                title 5, United States Code, and any 
                implementing regulations, in determining the 
                amount of payment under subsection (a) and the 
                circumstances under which such payments are 
                reasonable and necessary.
            (4) Treatment of self-employment income.--For 
        purposes of this section, the term ``employment 
        income'' includes income from self-employment.
    (c) Limitations.--
            (1) Benefits secondary to other coverage.--
                    (A) In general.--Any compensation under 
                subsection (a) shall be secondary to the 
                obligation of the United States or any third 
                party (including any State or local 
                governmental entity, private insurance carrier, 
                or employer), under any other law or 
                contractual agreement, to pay compensation for 
                loss of employment income or to provide 
                disability or retirement benefits.
                    (B) Relation to other obligations.--
                Compensation under subsection (a) shall not be 
                made to an eligible individual to the extent 
                that the total of amounts paid to the 
                individual under such subsection and under the 
                other obligations referred to in subparagraph 
                (A) is an amount that exceeds the rate 
                specified in subsection (b)(1). If under any 
                such other obligation a lump-sum payment is 
                made, such payment shall, for purposes of this 
                paragraph, be deemed to be received over 
                multiple years rather than received in a single 
                year. The Secretary may, in the discretion of 
                the Secretary, determine how to apportion such 
                payment over multiple years.
            (2) No benefits in case of death.--No payment shall 
        be made under subsection (a) in compensation for loss 
        of employment income subsequent to the receipt, by the 
        survivor or survivors of an eligible individual, of 
        benefits under section 266 for death.
            (3) Limit on total benefits.--
                    (A) In general.--Except as provided in 
                subparagraph (B)--
                            (i) total compensation paid to an 
                        individual under subsection (a) shall 
                        not exceed $50,000 for any year; and
                            (ii) the lifetime total of such 
                        compensation for the individual may not 
                        exceed an amount equal to the amount 
                        authorized to be paid under section 
                        266.
                    (B) Permanent and total disability.--The 
                limitation under subparagraph (A)(ii) does not 
                apply in the case of an eligible individual who 
                is determined to have a covered injury or 
                injuries meeting the definition of disability 
                in section 216(i) of the Social Security Act 
                (42 U.S.C. 416(i)).
            (4) Waiting period.--
                    (A) In general.--Except as provided in 
                subparagraph (B), an eligible individual shall 
                not be provided compensation under this section 
                for the first 5 work days of loss of employment 
                income.
                    (B) Exception.--Subparagraph (A) does not 
                apply if the period of loss of employment 
                income of an eligible individual is 10 or more 
                work days.
            (5) Termination of benefits.--No payment shall be 
        made under subsection (a) in compensation for loss of 
        employment income once the eligible individual involves 
        reaches the age of 65.
    (d) Benefit in Addition to Medical Benefits.--A benefit 
under subsection (a) shall be in addition to any amounts 
received by an eligible individual under section 264.

SEC. 266. [239E] PAYMENT FOR DEATH.

    (a) Death Benefit.--
            (1) In general.--The Secretary shall pay, in the 
        case of an eligible individual whose death is 
        determined to have resulted from a covered injury or 
        injuries, a death benefit in the amount determined 
        under paragraph (2) to the survivor or survivors in the 
        same manner as death benefits are paid pursuant to the 
        Public Safety Officers' Benefits Program under subpart 
        1 of part L of title I of the Omnibus Crime Control and 
        Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.) with 
        respect to an eligible deceased (except that in the 
        case of an eligible individual who is a minor with no 
        living parent, the legal guardian shall be considered 
        the survivor in the place of the parent).
            (2) Benefit amount.--
                    (A) In general.--The amount of the death 
                benefit under paragraph (1) in a fiscal year 
                shall equal the amount of the comparable 
                benefit calculated under the Public Safety 
                Officers' Benefits Program under subpart 1 of 
                part L of title I of the Omnibus Crime Control 
                and Safe Streets Act of 1968 (42 U.S.C. 3796 et 
                seq.) in such fiscal year, without regard to 
                any reduction attributable to a limitation on 
                appropriations, but subject to subparagraph 
                (B).
                    (B) Reduction for payments for lost 
                employment income.--The amount of the benefit 
                as determined under subparagraph (A) shall be 
                reduced by the total amount of any benefits 
                paid under section 265 with respect to lost 
                employment income.
            (3) Limitations.--
                    (A) In general.--No benefit is payable 
                under paragraph (1) with respect to the death 
                of an eligible individual if--
                            (i) a disability benefit is paid 
                        with respect to such individual under 
                        the Public Safety Officers' Benefits 
                        Program under subpart 1 of part L of 
                        title I of the Omnibus Crime Control 
                        and Safe Streets Act of 1968 (42 U.S.C. 
                        3796 et seq.); or
                            (ii) a death benefit is paid or 
                        payable with respect to such individual 
                        under the Public Safety Officers' 
                        Benefits Program under subpart 1 of 
                        part L of title I of the Omnibus Crime 
                        Control and Safe Streets Act of 1968 
                        (42 U.S.C. 3796 et seq.).
                    (B) Exception in the case of a limitation 
                on appropriations for disability benefits under 
                psob.--In the event that disability benefits 
                available to an eligible individual under the 
                Public Safety Officers' Benefits Program under 
                subpart 1 of part L of title I of the Omnibus 
                Crime Control and Safe Streets Act of 1968 (42 
                U.S.C. 3796 et seq.) are reduced because of a 
                limitation on appropriations, and such 
                reduction would affect the amount that would be 
                payable under subparagraph (A) without regard 
                to this subparagraph, benefits shall be 
                available under paragraph (1) to the extent 
                necessary to ensure that the survivor or 
                survivors of such individual receives a total 
                amount equal to the amount described in 
                paragraph (2).
    (b) Election in Case of Dependents.--
            (1) In general.--In the case of an eligible 
        individual whose death is determined to have resulted 
        from a covered injury or injuries, if the individual 
        had one or more dependents under the age of 18, the 
        legal guardian of the dependents may, in lieu of the 
        death benefit under subsection (a), elect to receive on 
        behalf of the aggregate of such dependents payments in 
        accordance with this subsection. An election under the 
        preceding sentence is effective in lieu of a request 
        under subsection (a) by an individual who is not the 
        legal guardian of such dependents.
            (2) Amount of payments.--Payments under paragraph 
        (1) with respect to an eligible individual described in 
        such paragraph shall be made as if such individual were 
        an eligible individual to whom compensation would be 
        paid under subsection (a) of section 265, with the rate 
        augmented in accordance with subsection (b)(2) of such 
        section and with such individual considered to be an 
        eligible individual described in subsection (c)(3)(B) 
        of such section.
            (3) Limitations.--
                    (A) Age of dependents.--No payments may be 
                made under paragraph (1) once the youngest of 
                the dependents involved reaches the age of 18.
                    (B) Benefits secondary to other coverage.--
                            (i) In general.--Any payment under 
                        paragraph (1) shall be secondary to the 
                        obligation of the United States or any 
                        third party (including any State or 
                        local governmental entity, private 
                        insurance carrier, or employer), under 
                        any other law or contractual agreement, 
                        to pay compensation for loss of 
                        employment income or to provide 
                        disability benefits, retirement 
                        benefits, life insurance benefits on 
                        behalf of dependents under the age of 
                        18, or death benefits.
                            (ii) Relation to other 
                        obligations.--Payments under paragraph 
                        (1) shall not be made to with respect 
                        to an eligible individual to the extent 
                        that the total of amounts paid with 
                        respect to the individual under such 
                        paragraph and under the other 
                        obligations referred to in clause (i) 
                        is an amount that exceeds the rate of 
                        payment that applies under paragraph 
                        (2). If under any such other obligation 
                        a lump-sum payment is made, such 
                        payment shall, for purposes of this 
                        subparagraph, be deemed to be received 
                        over multiple years rather than 
                        received in a single year. The 
                        Secretary may, in the discretion of the 
                        Secretary, determine how to apportion 
                        such payment over multiple years.
    (c) Benefit in Addition to Medical Benefits.--A benefit 
under subsection (a) or (b) shall be in addition to any amounts 
received by an eligible individual under section 264.

SEC. 267. [239F] ADMINISTRATION.

    (a) Administration by Agreement With Other Agency or 
Agencies.--The Secretary may administer any or all of the 
provisions of this part through Memorandum of Agreement with 
the head of any appropriate Federal agency.
    (b) Regulations.--The head of the agency administering this 
part or provisions thereof (including any agency head 
administering such Act or provisions through a Memorandum of 
Agreement under subsection (a)) may promulgate such 
implementing regulations as may be found necessary and 
appropriate. Initial implementing regulations may be interim 
final regulations.

SEC. 268. [239G] AUTHORIZATION OF APPROPRIATIONS.

    For the purpose of carrying out this part, there are 
authorized to be appropriated such sums as may be necessary for 
each of the fiscal years 2003 through 2007, to remain available 
until expended, including administrative costs and costs of 
provision and payment of benefits. The Secretary's payment of 
any benefit under section 264, 265, or 266 shall be subject to 
the availability of appropriations under this section.

SEC. 269. [239H] RELATIONSHIP TO OTHER LAWS.

    Except as explicitly provided herein, nothing in this part 
shall be construed to override or limit any rights an 
individual may have to seek compensation, benefits, or redress 
under any other provision of Federal or State law.

           PART D--UNITED STATES PUBLIC HEALTH SCIENCES TRACK

SEC. 271. [239L] ESTABLISHMENT.

    (a) United States Public Health Services Track.--
            (1) In general.--There is hereby authorized to be 
        established a United States Public Health Sciences 
        Track (referred to in this part as the ``Track''), at 
        sites to be selected by the Secretary, with authority 
        to grant appropriate advanced degrees in a manner that 
        uniquely emphasizes team-based service, public health, 
        epidemiology, and emergency preparedness and response. 
        It shall be so organized as to graduate not less than--
                    (A) 150 medical students annually, 10 of 
                whom shall be awarded studentships to the 
                Uniformed Services University of Health 
                Sciences;
                    (B) 100 dental students annually;
                    (C) 250 nursing students annually;
                    (D) 100 public health students annually;
                    (E) 100 behavioral and mental health 
                professional students annually;
                    (F) 100 physician assistant or nurse 
                practitioner students annually; and
                    (G) 50 pharmacy students annually.
            (2) Locations.--The Track shall be located at 
        existing and accredited, affiliated health professions 
        education training programs at academic health centers 
        located in regions of the United States determined 
        appropriate by the Surgeon General, in consultation 
        with the National Health Care Workforce Commission 
        established in section 5101 of the Patient Protection 
        and Affordable Care Act.
    (b) Number of Graduates.--Except as provided in subsection 
(a), the number of persons to be graduated from the Track shall 
be prescribed by the Secretary. In so prescribing the number of 
persons to be graduated from the Track, the Secretary shall 
institute actions necessary to ensure the maximum number of 
first-year enrollments in the Track consistent with the 
academic capacity of the affiliated sites and the needs of the 
United States for medical, dental, and nursing personnel.
    (c) Development.--The development of the Track may be by 
such phases as the Secretary may prescribe subject to the 
requirements of subsection (a).
    (d) Integrated Longitudinal Plan.--The Surgeon General 
shall develop an integrated longitudinal plan for health 
professions continuing education throughout the continuum of 
health-related education, training, and practice. Training 
under such plan shall emphasize patient-centered, 
interdisciplinary, and care coordination skills. Experience 
with deployment of emergency response teams shall be included 
during the clinical experiences.
    (e) Faculty Development.--The Surgeon General shall develop 
faculty development programs and curricula in decentralized 
venues of health care, to balance urban, tertiary, and 
inpatient venues.

SEC. 272. [239L-1] ADMINISTRATION.

    (a) In General.--The business of the Track shall be 
conducted by the Surgeon General with funds appropriated for 
and provided by the Department of Health and Human Services. 
The National Health Care Workforce Commission shall assist the 
Surgeon General in an advisory capacity.
    (b) Faculty.--
            (1) In general.--The Surgeon General, after 
        considering the recommendations of the National Health 
        Care Workforce Commission, shall obtain the services of 
        such professors, instructors, and administrative and 
        other employees as may be necessary to operate the 
        Track, but utilize when possible, existing affiliated 
        health professions training institutions. Members of 
        the faculty and staff shall be employed under salary 
        schedules and granted retirement and other related 
        benefits prescribed by the Secretary so as to place the 
        employees of the Track faculty on a comparable basis 
        with the employees of fully accredited schools of the 
        health professions within the United States.
            (2) Titles.--The Surgeon General may confer 
        academic titles, as appropriate, upon the members of 
        the faculty.
            (3) Nonapplication of provisions.--The limitations 
        in section 5373 of title 5, United States Code, shall 
        not apply to the authority of the Surgeon General under 
        paragraph (1) to prescribe salary schedules and other 
        related benefits.
    (c) Agreements.--The Surgeon General may negotiate 
agreements with agencies of the Federal Government to utilize 
on a reimbursable basis appropriate existing Federal medical 
resources located in the United States (or locations selected 
in accordance with section 271(a)(2)). Under such agreements 
the facilities concerned will retain their identities and basic 
missions. The Surgeon General may negotiate affiliation 
agreements with accredited universities and health professions 
training institutions in the United States. Such agreements may 
include provisions for payments for educational services 
provided students participating in Department of Health and 
Human Services educational programs.
    (d) Programs.--The Surgeon General may establish the 
following educational programs for Track students:
            (1) Postdoctoral, postgraduate, and technological 
        programs.
            (2) A cooperative program for medical, dental, 
        physician assistant, pharmacy, behavioral and mental 
        health, public health, and nursing students.
            (3) Other programs that the Surgeon General 
        determines necessary in order to operate the Track in a 
        cost-effective manner.
    (e) Continuing Medical Education.--The Surgeon General 
shall establish programs in continuing medical education for 
members of the health professions to the end that high 
standards of health care may be maintained within the United 
States.
    (f) Authority of the Surgeon General.--
            (1) In general.--The Surgeon General is 
        authorized--
                    (A) to enter into contracts with, accept 
                grants from, and make grants to any nonprofit 
                entity for the purpose of carrying out 
                cooperative enterprises in medical, dental, 
                physician assistant, pharmacy, behavioral and 
                mental health, public health, and nursing 
                research, consultation, and education;
                    (B) to enter into contracts with entities 
                under which the Surgeon General may furnish the 
                services of such professional, technical, or 
                clerical personnel as may be necessary to 
                fulfill cooperative enterprises undertaken by 
                the Track;
                    (C) to accept, hold, administer, invest, 
                and spend any gift, devise, or bequest of 
                personal property made to the Track, including 
                any gift, devise, or bequest for the support of 
                an academic chair, teaching, research, or 
                demonstration project;
                    (D) to enter into agreements with entities 
                that may be utilized by the Track for the 
                purpose of enhancing the activities of the 
                Track in education, research, and technological 
                applications of knowledge; and
                    (E) to accept the voluntary services of 
                guest scholars and other persons.
            (2) Limitation.--The Surgeon General may not enter 
        into any contract with an entity if the contract would 
        obligate the Track to make outlays in advance of the 
        enactment of budget authority for such outlays.
            (3) Scientists.--Scientists or other medical, 
        dental, or nursing personnel utilized by the Track 
        under an agreement described in paragraph (1) may be 
        appointed to any position within the Track and may be 
        permitted to perform such duties within the Track as 
        the Surgeon General may approve.
            (4) Volunteer services.--A person who provides 
        voluntary services under the authority of subparagraph 
        (E) of paragraph (1) shall be considered to be an 
        employee of the Federal Government for the purposes of 
        chapter 81 of title 5, relating to compensation for 
        work-related injuries, and to be an employee of the 
        Federal Government for the purposes of chapter 171 of 
        title 28, relating to tort claims. Such a person who is 
        not otherwise employed by the Federal Government shall 
        not be considered to be a Federal employee for any 
        other purpose by reason of the provision of such 
        services.

SEC. 273. [239L-2] STUDENTS; SELECTION; OBLIGATION.

    (a) Student Selection.--
            (1) In general.--Medical, dental, physician 
        assistant, pharmacy, behavioral and mental health, 
        public health, and nursing students at the Track shall 
        be selected under procedures prescribed by the Surgeon 
        General. In so prescribing, the Surgeon General shall 
        consider the recommendations of the National Health 
        Care Workforce Commission.
            (2) Priority.--In developing admissions procedures 
        under paragraph (1), the Surgeon General shall ensure 
        that such procedures give priority to applicant 
        medical, dental, physician assistant, pharmacy, 
        behavioral and mental health, public health, and 
        nursing students from rural communities and 
        underrepresented minorities.
    (b) Contract and Service Obligation.--
            (1) Contract.--Upon being admitted to the Track, a 
        medical, dental, physician assistant, pharmacy, 
        behavioral and mental health, public health, or nursing 
        student shall enter into a written contract with the 
        Surgeon General that shall contain--
                    (A) an agreement under which--
                            (i) subject to subparagraph (B), 
                        the Surgeon General agrees to provide 
                        the student with tuition (or tuition 
                        remission) and a student stipend 
                        (described in paragraph (2)) in each 
                        school year for a period of years (not 
                        to exceed 4 school years) determined by 
                        the student, during which period the 
                        student is enrolled in the Track at an 
                        affiliated or other participating 
                        health professions institution pursuant 
                        to an agreement between the Track and 
                        such institution; and
                            (ii) subject to subparagraph (B), 
                        the student agrees--
                                    (I) to accept the provision 
                                of such tuition and student 
                                stipend to the student;
                                    (II) to maintain enrollment 
                                at the Track until the student 
                                completes the course of study 
                                involved;
                                    (III) while enrolled in 
                                such course of study, to 
                                maintain an acceptable level of 
                                academic standing (as 
                                determined by the Surgeon 
                                General);
                                    (IV) if pursuing a degree 
                                from a school of medicine or 
                                osteopathic medicine, dental, 
                                public health, or nursing 
                                school or a physician 
                                assistant, pharmacy, or 
                                behavioral and mental health 
                                professional program, to 
                                complete a residency or 
                                internship in a specialty that 
                                the Surgeon General determines 
                                is appropriate; and
                                    (V) to serve for a period 
                                of time (referred to in this 
                                part as the ``period of 
                                obligated service'') within the 
                                Commissioned Corps of the 
                                Public Health Service equal to 
                                2 years for each school year 
                                during which such individual 
                                was enrolled at the College, 
                                reduced as provided for in 
                                paragraph (3);
                    (B) a provision that any financial 
                obligation of the United States arising out of 
                a contract entered into under this part and any 
                obligation of the student which is conditioned 
                thereon, is contingent upon funds being 
                appropriated to carry out this part;
                    (C) a statement of the damages to which the 
                United States is entitled for the student's 
                breach of the contract; and
                    (D) such other statements of the rights and 
                liabilities of the Secretary and of the 
                individual, not inconsistent with the 
                provisions of this part.
            (2) Tuition and student stipend.--
                    (A) Tuition remission rates.--The Surgeon 
                General, based on the recommendations of the 
                National Health Care Workforce Commission, 
                shall establish Federal tuition remission rates 
                to be used by the Track to provide 
                reimbursement to affiliated and other 
                participating health professions institutions 
                for the cost of educational services provided 
                by such institutions to Track students. The 
                agreement entered into by such participating 
                institutions under paragraph (1)(A)(i) shall 
                contain an agreement to accept as payment in 
                full the established remission rate under this 
                subparagraph.
                    (B) Stipend.--The Surgeon General, based on 
                the recommendations of the National Health Care 
                Workforce Commission, shall establish and 
                update Federal stipend rates for payment to 
                students under this part.
            (3) Reductions in the period of obligated 
        service.--The period of obligated service under 
        paragraph (1)(A)(ii)(V) shall be reduced--
                    (A) in the case of a student who elects to 
                participate in a high-needs speciality 
                residency (as determined by the National Health 
                Care Workforce Commission), by 3 months for 
                each year of such participation (not to exceed 
                a total of 12 months); and
                    (B) in the case of a student who, upon 
                completion of their residency, elects to 
                practice in a Federal medical facility (as 
                defined in section 781(e)) that is located in a 
                health professional shortage area (as defined 
                in section 332), by 3 months for year of full-
                time practice in such a facility (not to exceed 
                a total of 12 months).
    (c) Second 2 Years of Service.--During the third and fourth 
years in which a medical, dental, physician assistant, 
pharmacy, behavioral and mental health, public health, or 
nursing student is enrolled in the Track, training should be 
designed to prioritize clinical rotations in Federal medical 
facilities in health professional shortage areas, and emphasize 
a balance of hospital and community-based experiences, and 
training within interdisciplinary teams.
    (d) Dentist, Physician Assistant, Pharmacist, Behavioral 
and Mental Health Professional, Public Health Professional, and 
Nurse Training.--The Surgeon General shall establish provisions 
applicable with respect to dental, physician assistant, 
pharmacy, behavioral and mental health, public health, and 
nursing students that are comparable to those for medical 
students under this section, including service obligations, 
tuition support, and stipend support. The Surgeon General shall 
give priority to health professions training institutions that 
train medical, dental, physician assistant, pharmacy, 
behavioral and mental health, public health, and nursing 
students for some significant period of time together, but at a 
minimum have a discrete and shared core curriculum.
    (e) Elite Federal Disaster Teams.--The Surgeon General, in 
consultation with the Secretary, the Director of the Centers 
for Disease Control and Prevention, and other appropriate 
military and Federal government agencies, shall develop 
criteria for the appointment of highly qualified Track faculty, 
medical, dental, physician assistant, pharmacy, behavioral and 
mental health, public health, and nursing students, and 
graduates to elite Federal disaster preparedness teams to train 
and to respond to public health emergencies, natural disasters, 
bioterrorism events, and other emergencies.
    (f) Student Dropped From Track in Affiliate School.--A 
medical, dental, physician assistant, pharmacy, behavioral and 
mental health, public health, or nursing student who, under 
regulations prescribed by the Surgeon General, is dropped from 
the Track in an affiliated school for deficiency in conduct or 
studies, or for other reasons, shall be liable to the United 
States for all tuition and stipend support provided to the 
student.

SEC. 274. [239L-3] FUNDING.

    Beginning with fiscal year 2010, the Secretary shall 
transfer from the Public Health and Social Services Emergency 
Fund such sums as may be necessary to carry out this 
part.3/1/01 9:05:59 AM - F:\V7\030101\030101.005 
Created by: PMG deg.ATTORNEY: PMG/FD (May 26, 
1999) deg.
     TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

                   Part A--Research and Investigation

                               in general

    Sec. 301. [241] (a) The Secretary shall conduct in the 
Service, and encourage, cooperate with, and render assistance 
to other appropriate public authorities, scientific 
institutions, and scientists in the conduct of, and promote the 
coordination of, research, investigations, experiments, 
demonstrations, and studies relating to the causes, diagnosis, 
treatment, control, and prevention of physical and mental 
diseases and impairments of man, including water purification, 
sewage treatment, and pollution of lakes and streams. In 
carrying out the foregoing the Secretary is authorized to--
            (1) collect and make available through publications 
        and other appropriate means, information as to, and the 
        practical application of, such research and other 
        activities;
            (2) make available research facilities of the 
        Service to appropriate public authorities, and to 
        health officials and scientists engaged in special 
        study;
            (3) make grants-in-aid to universities, hospitals, 
        laboratories, and other public or private institutions, 
        and to individuals for such research projects as are 
        recommended by the advisory council to the entity of 
        the Department supporting such projects and make, upon 
        recommendation of the advisory council to the 
        appropriate entity of the Department, grants-in-aid to 
        public or nonprofit universities, hospitals, 
        laboratories, and other institutions for the general 
        support of their research;
            (4) secure from time to time and for such periods 
        as he deems advisable, the assistance and advice of 
        experts, scholars, and consultants from the United 
        States or abroad;
            (5) for purposes of study, admit and treat at 
        institutions, hospitals, and stations of the Service, 
        persons not otherwise eligible for such treatment;
            (6) make available, to health officials, 
        scientists, and appropriate public and other nonprofit 
        institutions and organizations, technical advice and 
        assistance on the application of statistical methods to 
        experiments, studies, and surveys in health and medical 
        fields;
            (7) enter into contracts, including contracts for 
        research in accordance with and subject to the 
        provisions of law applicable to contracts entered into 
        by the military departments under title 10, United 
        States Code, sections 2353 and 2354, except that 
        determination, approval, and certification required 
        thereby shall be by the Secretary of Health, Education, 
        and Welfare; and
            (8) adopt, upon recommendations of the advisory 
        councils to the appropriate entities of the Department 
        or, with respect to mental health, the National 
        Advisory Mental Health Council, such additional means 
        as the Secretary considers necessary or appropriate to 
        carry out the purposes of this section.
The Secretary may make available to individuals and entities, 
for biomedical and behavioral research, substances and living 
organisms. Such substances and organisms shall be made 
available under such terms and conditions (including payment 
for them) as the Secretary determines appropriate.
    (b)(1) The Secretary shall conduct and may support through 
grants and contracts studies and testing of substances for 
carcinogenicity, teratogenicity, mutagenicity, and other 
harmful biological effects. In carrying out this paragraph, the 
Secretary shall consult with entities of the Federal 
Government, outside of the Department of Health, Education, and 
Welfare, engaged in comparable activities. The Secretary, upon 
request of such an entity and under appropriate arrangements 
for the payment of expenses, may conduct for such entity 
studies and testing of substances for carcinogenicity, 
teratogenicity, mutagenicity, and other harmful biological 
effects.
    (2)(A) The Secretary shall establish a comprehensive 
program of research into the biological effects of low-level 
ionizing radiation under which program the Secretary shall 
conduct such research and may support such research by others 
through grants and contracts.
    (B) The Secretary shall conduct a comprehensive review of 
Federal programs of research on the biological effects of 
ionizing radiation.
    (3) The Secretary shall conduct and may support through 
grants and contracts research and studies on human nutrition, 
with particular emphasis on the role of nutrition in the 
prevention and treatment of disease and on the maintenance and 
promotion of health, and programs for the dissemination of 
information respecting human nutrition to health professionals 
and the public. In carrying out activities under this 
paragraph, the Secretary shall provide for the coordination of 
such of these activities as are performed by the different 
divisions within the Department of Health, Education, and 
Welfare and shall consult with entities of the Federal 
Government, outside of the Department of Health, Education, and 
Welfare, engaged in comparable activities. The Secretary, upon 
request of such an entity and under appropriate arrangements 
for the payment of expenses, may conduct and support such 
activities for such entity.
    (4) The Secretary shall publish a biennial report which 
contains--
            (A) a list of all substances (i) which either are 
        known to be carcinogens or may reasonably be 
        anticipated to be carcinogens and (ii) to which a 
        significant number of persons residing in the United 
        States are exposed;
            (B) information concerning the nature of such 
        exposure and the estimated number of persons exposed to 
        such substances;
            (C) a statement identifying (i) each substance 
        contained in the list under subparagraph (A) for which 
        no effluent, ambient, or exposure standard has been 
        established by a Federal agency, and (ii) for each 
        effluent, ambient, or exposure standard established by 
        a Federal agency with respect to a substance contained 
        in the list under subparagraph (A), the extent to 
        which, on the basis of available medical, scientific, 
        or other data, such standard, and the implementation of 
        such standard by the agency, decreases the risk to 
        public health from exposure to the substance; and
            (D) a description of (i) each request received 
        during the year involved--
                    (I) from a Federal agency outside the 
                Department of Health, Education, and Welfare 
                for the Secretary, or
                    (II) from an entity within the Department 
                of Health, Education, and Welfare to any other 
                entity within the Department,
        to conduct research into, or testing for, the 
        carcinogenicity of substances or to provide information 
        described in clause (ii) of subparagraph (C), and (ii) 
        how the Secretary and each such other entity, 
        respectively, have responded to each such request.
    (5) The authority of the Secretary to enter into any 
contract for the conduct of any study, testing, program, 
research, or review, or assessment under this subsection shall 
be effective for any fiscal year only to such extent or in such 
amounts as are provided in advance in Appropriation Acts.
      (c) The Secretary may conduct biomedical research, 
directly or through grants or contracts, for the 
identification, control, treatment, and prevention of diseases 
(including tropical diseases) which do not occur to a 
significant extent in the United States.
    (d) The Secretary may authorize persons engaged in 
biomedical, behavioral, clinical, or other research (including 
research on mental health, including research on the use and 
effect of alcohol and other psychoactive drugs) to protect the 
privacy of individuals who are the subject of such research by 
withholding from all persons not connected with the conduct of 
such research the names or other identifying characteristics of 
such individuals. Persons so authorized to protect the privacy 
of such individuals may not be compelled in any Federal, State, 
or local civil, criminal, administrative, legislative, or other 
proceedings to identify such individuals.
    (e) The Secretary, acting through the Director of the 
Centers for Disease Control and Prevention, shall expand, 
intensify, and coordinate the activities of the Centers for 
Disease Control and Prevention with respect to preterm labor 
and delivery and infant mortality.

                               narcotics

    Sec. 302. [242] (a) In carrying out the purposes of section 
301 with respect to drugs the use or misuse of which might 
result in drug abuse or dependency, the studies and 
investigations authorized therein shall include the use and 
misuse of narcotic drugs and other drugs. Such studies and 
investigations shall further include the quantities of crude 
opium, coca leaves, and their salts, derivatives, and 
preparations, and other drugs subject to control under the 
Controlled Substances Act and Controlled Substances Import and 
Export Act, together with reserves thereof, necessary to supply 
the normal and emergency medicinal and scientific requirements 
of the United States. The results of studies and investigations 
of the quantities of narcotic drugs or other drugs subject to 
control under such Acts, together with reserves of such drugs, 
that are necessary to supply the normal and emergency medicinal 
and scientific requirements of the United States, shall be 
reported not later than the first day of April of each year to 
the Attorney General, to be used at his discretion in 
determining manufacturing quotas or importation requirements 
under such Acts.
    (b) The Surgeon General shall cooperate with States for the 
purpose of aiding them to solve their narcotic drug problems 
and shall give authorized representatives of the States the 
benefit of his experience in the care, treatment, and 
rehabilitation of narcotic addicts to the end that each State 
may be encouraged to provide adequate facilities and methods 
for the care and treatment of its narcotic addicts.

general authority respecting research, evaluations, and demonstrations 
   in health statistics, health services, and health care technology 
                               assessment

    Sec. 304. \1\ [242b] (a) The Secretary may, through the 
Agency for Health Care Policy and Research or the National 
Center for Health Statistics or using National Research Service 
Awards or other appropriate authorities, undertake and support 
training programs to provide for an expanded and continuing 
supply of individuals qualified to perform the research, 
evaluation, and demonstration projects set forth in section 306 
and in title IX.
---------------------------------------------------------------------------
    \1\ Former section 303 was repealed by section 3201(b)(1) of Public 
Law 106-310 (114 Stat. 1190).
---------------------------------------------------------------------------
    (b) To implement subsection (a) and section 306, the 
Secretary may, in addition to any other authority which under 
other provisions of this Act or any other law may be used by 
him to implement such subsection, do the following:
            (1) Utilize personnel and equipment, facilities, 
        and other physical resources of the Department of 
        Health and Human Services, permit appropriate (as 
        determined by the Secretary) entities and individuals 
        to utilize the physical resources of such Department, 
        provide technical assistance and advice, make grants to 
        public and nonprofit private entities and individuals, 
        and, when appropriate, enter into contracts with public 
        and private entities and individuals.
            (2) Admit and treat at hospitals and other 
        facilities of the Service persons not otherwise 
        eligible for admission and treatment at such 
        facilities.
            (3) Secure, from time to time and for such periods 
        as the Secretary deems advisable but in accordance with 
        section 3109 of title 5, United States Code, the 
        assistance and advice of consultants from the United 
        States or abroad. The Secretary may for the purpose of 
        carrying out the functions set forth in sections 305, 
        \2\ 306, and 309, obtain (in accordance with section 
        3109 of title 5 of the United States Code, but without 
        regard to the limitation in such section on the number 
        of days or the period of service) for each of the 
        centers the services of not more than fifteen experts 
        who have appropriate scientific or professional 
        qualifications.
---------------------------------------------------------------------------
    \2\ See footnote for section 306.
---------------------------------------------------------------------------
            (4) Acquire, construct, improve, repair, operate, 
        and maintain laboratory, research, and other necessary 
        facilities and equipment, and such other real or 
        personal property (including patents) as the Secretary 
        deems necessary; and acquire, without regard to the Act 
        of March 3, 1877 (40 U.S.C. 34), by lease or otherwise, 
        through the Administrator of General Services, 
        buildings or parts of buildings in the District of 
        Columbia or communities located adjacent to the 
        District of Columbia.
    (c)(1) The Secretary shall coordinate all health services 
research, evaluations, and demonstrations, all health 
statistical and epidemiological activities, and all research, 
evaluations, and demonstrations respecting the assessment of 
health care technology undertaken and supported through units 
of the Department of Health and Human Services. To the maximum 
extent feasible such coordination shall be carried out through 
the Agency for Health Care Policy and Research and the National 
Center for Health Statistics.
    (2) The Secretary shall coordinate the health services 
research, evaluations, and demonstrations, the health 
statistical and (where appropriate) epidemiological activities, 
and the research, evaluations, and demonstrations respecting 
the assessment of health care technology authorized by this Act 
through the Agency for Health Care Policy and Research and the 
National Center for Health Statistics.
                 national center for health statistics
    Sec. 306. \1\ [242k] (a) There is established in the 
Department of Health and Human Services the National Center for 
Health Statistics (hereinafter in this section referred to as 
the ``Center'') which shall be under the direction of a 
Director who shall be appointed by the Secretary. The 
Secretary, acting through the Center, shall conduct and support 
statistical and epidemiological activities for the purpose of 
improving the effectiveness, efficiency, and quality of health 
services in the United States.
---------------------------------------------------------------------------
    \1\ Former section 305 was repealed by section 6103(d)(1)(A) of 
Public Law 101-239 (103 Stat. 2205). Title IX now applies to the matter 
with which former section 305 was concerned.
---------------------------------------------------------------------------
    (b) In carrying out subsection (a), the Secretary, acting 
through the Center--
            (1) shall collect statistics on--
                    (A) the extent and nature of illness and 
                disability of the population of the United 
                States (or of any groupings of the people 
                included in the population), including life 
                expectancy, the incidence of various acute and 
                chronic illnesses, and infant and maternal 
                morbidity and mortality,
                    (B) the impact of illness and disability of 
                the population on the economy of the United 
                States and on other aspects of the well-being 
                of its population (or of such groupings),
                    (C) environmental, social, and other health 
                hazards,
                    (D) determinants of health,
                    (E) health resources, including physicians, 
                dentists, nurses, and other health 
                professionals by specialty and type of practice 
                and the supply of services by hospitals, 
                extended care facilities, home health agencies, 
                and other health institutions,
                    (F) utilization of health care, including 
                utilization of (i) ambulatory health services 
                by specialties and types of practice of the 
                health professionals providing such services, 
                and (ii) services of hospitals, extended care 
                facilities, home health agencies, and other 
                institutions,
                    (G) health care costs and financing, 
                including the trends in health care prices and 
                cost, the sources of payments for health care 
                services, and Federal, State, and local 
                governmental expenditures for health care 
                services, and
                    (H) family formation, growth, and 
                dissolution;
            (2) shall undertake and support (by grant or 
        contract) research, demonstrations, and evaluations 
        respecting new or improved methods for obtaining 
        current data on the matters referred to in paragraph 
        (1);
            (3) may undertake and support (by grant or 
        contract) epidemiological research, demonstrations, and 
        evaluations on the matters referred to in paragraph 
        (1); and
            (4) may collect, furnish, tabulate, and analyze 
        statistics, and prepare studies, on matters referred to 
        in paragraph (1) upon request of public and nonprofit 
        private entities under arrangements under which the 
        entities will pay the cost of the service provided.
Amounts appropriated to the Secretary from payments made under 
arrangements made under paragraph (4) shall be available to the 
Secretary for obligation until expended.
    (c) The Center shall furnish such special statistical and 
epidemiological compilations and surveys as the Committee on 
Labor and Human Resources and the Committee on Appropriations 
of the Senate and the Committee on Energy and Commerce and the 
Committee on Appropriations of the House of Representatives may 
request. Such statistical and epidemiological compilations and 
surveys shall not be made subject to the payment of the actual 
or estimated cost of the preparation of such compilations and 
surveys.
    (d) To insure comparability and reliability of health 
statistics, the Secretary shall, through the Center, provide 
adequate technical assistance to assist State and local 
jurisdictions in the development of model laws dealing with 
issues of confidentiality and comparability of data.
    (e) For the purpose of producing comparable and uniform 
health information and statistics, there is established the 
Cooperative Health Statistics System. The Secretary, acting 
through the Center, shall--
            (1) coordinate the activities of Federal agencies 
        involved in the design and implementation of the 
        System;
            (2) undertake and support (by grant or contract) 
        research, development, demonstrations, and evaluations 
        respecting the System;
            (3) make grants to and enter into contracts with 
        State and local health agencies to assist them in 
        meeting the costs of data collection and other 
        activities carried out under the System; and
            (4) review the statistical activities of the 
        Department of Health and Human Services to assure that 
        they are consistent with the System.
States participating in the System shall designate a State 
agency to administer or be responsible for the administration 
of the statistical activities within the State under the 
System. The Secretary, acting through the Center, shall 
prescribe guidelines to assure that statistical activities 
within States participating in the system \1\ produce uniform 
and timely data and assure appropriate access to such data.
---------------------------------------------------------------------------
    \1\ So in law. Probably should be capitalized.
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    (f) To assist in carrying out this section, the Secretary, 
acting through the Center, shall cooperate and consult with the 
Departments of Commerce and Labor and any other interested 
Federal departments or agencies and with State and local health 
departments and agencies. For such purpose he shall utilize 
insofar as possible the services or facilities of any agency of 
the Federal Government and, without regard to section 3709 of 
the Revised Statutes (41 U.S.C. 5), of any appropriate State or 
other public agency, and may, without regard to such section, 
utilize the services or facilities of any private agency, 
organization, group, or individual, in accordance with written 
agreements between the head of such agency, organization, or 
group and the Secretary or between such individual and the 
Secretary. Payment, if any, for such services or facilities 
shall be made in such amounts as may be provided in such 
agreement.
    (g) To secure uniformity in the registration and collection 
of mortality, morbidity, and other health data, the Secretary 
shall prepare and distribute suitable and necessary forms for 
the collection and compilation of such data.
    (h)(1) There shall be an annual collection of data from the 
records of births, deaths, marriages, and divorces in 
registration areas. The data shall be obtained only from and 
restricted to such records of the States and municipalities 
which the Secretary, in his discretion, determines possess 
records affording satisfactory data in necessary detail and 
form. The Secretary shall encourage States and registration 
areas to obtain detailed data on ethnic and racial populations, 
including subpopulations of Hispanics, Asian Americans, and 
Pacific Islanders with significant representation in the State 
or registration area. Each State or registration area shall be 
paid by the Secretary the Federal share of its reasonable costs 
(as determined by the Secretary) for collecting and 
transcribing (at the request of the Secretary and by whatever 
method authorized by him) its records for such data.
    (2) There shall be an annual collection of data from a 
statistically valid sample concerning the general health, 
illness, and disability status of the civilian 
noninstitutionalized population. Specific topics to be 
addressed under this paragraph, on an annual or periodic basis, 
shall include the incidence of illness and accidental injuries, 
prevalence of chronic diseases and impairments, disability, 
physician visits, hospitalizations, and the relationship 
between demographic and socioeconomic characteristics and 
health characteristics.
    (i) The Center may provide to public and nonprofit private 
entities technical assistance in the effective use in such 
activities of statistics collected or compiled by the Center.
    (j) In carrying out the requirements of section 304(c) and 
paragraph (1) of subsection (e) of this section, the Secretary 
shall coordinate health statistical and epidemiological 
activities of the Department of Health and Human Services by--
            (1) establishing standardized means for the 
        collection of health information and statistics under 
        laws administered by the Secretary;
            (2) developing, in consultation with the National 
        Committee on Vital and Health Statistics, and 
        maintaining the minimum sets of data needed on a 
        continuing basis to fulfill the collection requirements 
        of subsection (b)(1);
            (3) after consultation with the National Committee 
        on Vital and Health Statistics, establishing standards 
        to assure the quality of health statistical and 
        epidemiological data collection, processing, and 
        analysis;
            (4) in the case of proposed health data collections 
        of the Department which are required to be reviewed by 
        the Director of the Office of Management and Budget 
        under section 3509 of title 44, United States Code, 
        reviewing such proposed collections to determine 
        whether they conform with the minimum sets of data and 
        the standards promulgated pursuant to paragraphs (2) 
        and (3), and if any such proposed collection is found 
        not to be in conformance, by taking such action as may 
        be necessary to assure that it will conform to such 
        sets of data and standards, and
            (5) periodically reviewing ongoing health data 
        collections of the Department, subject to review under 
        such section 3509, to determine if the collections are 
        being conducted in accordance with the minimum sets of 
        data and the standards promulgated pursuant to 
        paragraphs (2) and (3) and, if any such collection is 
        found not to be in conformance, by taking such action 
        as may be necessary to assure that the collection will 
        conform to such sets of data and standards not later 
        than the nineteenth day after the date of the 
        completion of the review of the collection.
    (k)(1) There is established in the Office of the Secretary 
a committee to be known as the National Committee on Vital and 
Health Statistics (hereinafter in this subsection, referred to 
as the ``Committee'') which shall consist of 18 members.
    (2) The members of the Committee shall be appointed from 
among persons who have distinguished themselves in the fields 
of health statistics, electronic interchange of health care 
information, privacy and security of electronic information, 
population-based public health, purchasing or financing health 
care services, integrated computerized health information 
systems, health services research, consumer interests in health 
information, health data standards, epidemiology, and the 
provision of health services. Members of the Committee shall be 
appointed for terms of 4 years.
    (3) Of the members of the Committee--
            (A) 1 shall be appointed, not later than 60 days 
        after the date of the enactment of the Health Insurance 
        Portability and Accountability Act of 1996, by the 
        Speaker of the House of Representatives after 
        consultation with the Minority Leader of the House of 
        Representatives;
            (B) 1 shall be appointed, not later than 60 days 
        after the date of the enactment of the Health Insurance 
        Portability and Accountability Act of 1996, by the 
        President pro tempore of the Senate after consultation 
        with the Minority Leader of the Senate; and
            (C) 16 shall be appointed by the Secretary.
    (4) Members of the Committee shall be compensated in 
accordance with section 208(c).
    (5) The Committee--
            (A) shall assist and advise the Secretary--
                    (i) to delineate statistical problems 
                bearing on health and health services which are 
                of national or international interest;
                    (ii) to stimulate studies of such problems 
                by other organizations and agencies whenever 
                possible or to make investigations of such 
                problems through subcommittees;
                    (iii) to determine, approve, and revise the 
                terms, definitions, classifications, and 
                guidelines for assessing health status and 
                health services, their distribution and costs, 
                for use (I) within the Department of Health and 
                Human Services, (II) by all programs 
                administered or funded by the Secretary, 
                including the Federal-State-local cooperative 
                health statistics system referred to in 
                subsection (e), and (III) to the extent 
                possible as determined by the head of the 
                agency involved, by the Department of Veterans 
                Affairs, the Department of Defense, and other 
                Federal agencies concerned with health and 
                health services;
                    (iv) with respect to the design of and 
                approval of health statistical and health 
                information systems concerned with the 
                collection, processing, and tabulation of 
                health statistics within the Department of 
                Health and Human Services, with respect to the 
                Cooperative Health Statistics System 
                established under subsection (e), and with 
                respect to the standardized means for the 
                collection of health information and statistics 
                to be established by the Secretary under 
                subsection (j)(1);
                    (v) to review and comment on findings and 
                proposals developed by other organizations and 
                agencies and to make recommendations for their 
                adoption or implementation by local, State, 
                national, or international agencies;
                    (vi) to cooperate with national committees 
                of other countries and with the World Health 
                Organization and other national agencies in the 
                studies of problems of mutual interest;
                    (vii) to issue an annual report on the 
                state of the Nation's health, its health 
                services, their costs and distributions, and to 
                make proposals for improvement of the Nation's 
                health statistics and health information 
                systems; and
                    (viii) in complying with the requirements 
                imposed on the Secretary under part C of title 
                XI of the Social Security Act;
            (B) shall study the issues related to the adoption 
        of uniform data standards for patient medical record 
        information and the electronic exchange of such 
        information;
            (C) shall report to the Secretary not later than 4 
        years after the date of the enactment of the Health 
        Insurance Portability and Accountability Act of 1996 
        recommendations and legislative proposals for such 
        standards and electronic exchange; and
            (D) shall be responsible generally for advising the 
        Secretary and the Congress on the status of the 
        implementation of part C of title XI of the Social 
        Security Act.
    (6) In carrying out health statistical activities under 
this part, the Secretary shall consult with, and seek the 
advice of, the Committee and other appropriate professional 
advisory groups.
    (7) Not later than 1 year after the date of the enactment 
of the Health Insurance Portability and Accountability Act of 
1996, and annually thereafter, the Committee shall submit to 
the Congress, and make public, a report regarding the 
implementation of part C of title XI of the Social Security 
Act. Such report shall address the following subjects, to the 
extent that the Committee determines appropriate:
            (A) The extent to which persons required to comply 
        with part C of title XI of the Social Security Act are 
        cooperating in implementing the standards adopted under 
        such part.
            (B) The extent to which such entities are meeting 
        the security standards adopted under such part and the 
        types of penalties assessed for noncompliance with such 
        standards.
            (C) Whether the Federal and State Governments are 
        receiving information of sufficient quality to meet 
        their responsibilities under such part.
            (D) Any problems that exist with respect to 
        implementation of such part.
            (E) The extent to which timetables under such part 
        are being met.
    (l) In carrying out this section, the Secretary, acting 
through the Center, shall collect and analyze adequate health 
data that is specific to particular ethnic and racial 
populations, including data collected under national health 
surveys. Activities carried out under this subsection shall be 
in addition to any activities carried out under subsection (m).
    (m)(1) The Secretary, acting through the Center, may make 
grants to public and nonprofit private entities for--
            (A) the conduct of special surveys or studies on 
        the health of ethnic and racial populations or 
        subpopulations;
            (B) analysis of data on ethnic and racial 
        populations and subpopulations; and
            (C) research on improving methods for developing 
        statistics on ethnic and racial populations and 
        subpopulations.
    (2) The Secretary, acting through the Center, may provide 
technical assistance, standards, and methodologies to grantees 
supported by this subsection in order to maximize the data 
quality and comparability with other studies.
    (3) Provisions of section 308(d) do not apply to surveys or 
studies conducted by grantees under this subsection unless the 
Secretary, in accordance with regulations the Secretary may 
issue, determines that such provisions are necessary for the 
conduct of the survey or study and receives adequate assurance 
that the grantee will enforce such provisions.
    (4)(A) Subject to subparagraph (B), the Secretary, acting 
through the Center, shall collect data on Hispanics and major 
Hispanic subpopulation groups and American Indians, and for 
developing special area population studies on major Asian 
American and Pacific Islander populations.
    (B) The provisions of subparagraph (A) shall be effective 
with respect to a fiscal year only to the extent that funds are 
appropriated pursuant to paragraph (3) of subsection (n), and 
only if the amounts appropriated for such fiscal year pursuant 
to each of paragraphs (1) and (2) of subsection (n) equal or 
exceed the amounts so appropriated for fiscal year 1997.
    (n)(1) For health statistical and epidemiological 
activities undertaken or supported under subsections (a) 
through (l), there are authorized to be appropriated such sums 
as may be necessary for each of the fiscal years 1991 through 
2003.
    (2) For activities authorized in paragraphs (1) through (3) 
of subsection (m), there are authorized to be appropriated such 
sums as may be necessary for each of the fiscal years 1999 
through 2003. Of such amounts, the Secretary shall use not more 
than 10 percent for administration and for activities described 
in subsection (m)(2).
    (3) For activities authorized in subsection (m)(4), there 
are authorized to be appropriated $1,000,000 for fiscal year 
1998, and such sums as may be necessary for each of the fiscal 
years 1999 through 2002.
                       international cooperation
    Sec. 307. [242l] (a) The Secretary may participate with 
other countries in cooperative endeavors in--
            (1) biomedical research, health care technology, 
        and the health services research and statistical 
        analysis authorized under section 306 and title IX; and
            (2) biomedical research, health care services, 
        health care research, or other related activities in 
        furtherance of the activities, objectives or goals 
        authorized under the Tom Lantos and Henry J. Hyde 
        United States Global Leadership Against HIV/AIDS, 
        Tuberculosis, and Malaria Reauthorization Act of 2008.
    (b) In connection with the cooperative endeavors authorized 
by subsection (a), the Secretary may--
            (1) make such use of resources offered by 
        participating foreign countries as he may find 
        necessary and appropriate;
            (2) establish and maintain fellowships in the 
        United States and in participating foreign countries;
            (3) make grants to public institutions or agencies 
        and to nonprofit private institutions or agencies in 
        the United States and in participating foreign 
        countries for the purpose of establishing and 
        maintaining the fellowships authorized by paragraph 
        (2);
            (4) make grants or loans of equipment and 
        materials, for use by public or nonprofit private 
        institutions or agencies, or by individuals, in 
        participating foreign countries;
            (5) participate and otherwise cooperate in any 
        international meetings, conferences, or other 
        activities concerned with biomedical research, health 
        services research, health statistics, or health care 
        technology;
            (6) facilitate the interchange between the United 
        States and participating foreign countries, and among 
        participating foreign countries, of research scientists 
        and experts who are engaged in experiments or programs 
        of biomedical research, health services research, 
        health statistical activities, or health care 
        technology activities, and in carrying out such purpose 
        may pay per diem compensation, subsistence, and travel 
        for such scientists and experts when away from their 
        places of residence at rates not to exceed those 
        provided in section 5703(b) of title 5, United States 
        Code, for persons in the Government service employed 
        intermittently;
            (7) procure, in accordance with section 3109 of 
        title 5, United States Code, the temporary or 
        intermittent services of experts or consultants;
            (8) enter into contracts with individuals for the 
        provision of services (as defined in section 104 of 
        part 37 of title 48, Code of Federal Regulations (48 
        CFR 37.104)) in participating foreign countries, which 
        individuals may not be deemed employees of the United 
        States for the purpose of any law administered by the 
        Office of Personnel Management;
            (9) provide such funds by advance or reimbursement 
        to the Secretary of State, as may be necessary, to pay 
        the costs of acquisition, lease, construction, 
        alteration, equipping, furnishing or management of 
        facilities outside of the United States; and
            (10) in consultation with the Secretary of State, 
        through grant or cooperative agreement, make funds 
        available to public or nonprofit private institutions 
        or agencies in foreign countries in which the Secretary 
        is participating in activities described under 
        subsection (a) to acquire, lease, construct, alter, or 
        renovate facilities in those countries.
    (c) The Secretary may provide to personnel appointed or 
assigned by the Secretary to serve abroad, allowances and 
benefits similar to those provided under chapter 9 of title I 
of the Foreign Service Act of 1980 (22 U.S.C. 4081 et seq.). 
Leaves of absence for personnel under this subsection shall be 
on the same basis as that provided under subchapter I of 
chapter 63 of title 5, United States Code or section 903 of the 
Foreign Service Act of 1980 (22 U.S.C. 4083), to individuals 
serving in the Foreign Service.
    (d) In carrying out immunization programs and other 
programs in developing countries for the prevention, treatment, 
and control of infectious diseases, including HIV/AIDS, 
tuberculosis, and malaria, the Director of the Centers for 
Disease Control and Prevention, in coordination with the 
Coordinator of United States Government Activities to Combat 
HIV/AIDS Globally, the National Institutes of Health, national 
and local government, and other organizations, such as the 
World Health Organization and the United Nations Children's 
Fund, shall develop and implement effective strategies to 
improve injection safety, including eliminating unnecessary 
injections, promoting sterile injection practices and 
technologies, strengthening the procedures for proper needle 
and syringe disposal, and improving the education and 
information provided to the public and to health professionals.

general provisions respecting effectiveness, efficiency, and quality of 
                            health services

    Sec. 308. [242m] (a)(1) Not later than March 15 of each 
year, the Secretary shall submit to the President and Congress 
the following reports:
            (A) A report on health care costs and financing. 
        Such report shall include a description and analysis of 
        the statistics collected under section 306(b)(1)(G).
            (B) A report on health resources. Such report shall 
        include a description and analysis, by geographical 
        area, of the statistics collected under section 
        306(b)(1)(E).
            (C) A report on the utilization of health 
        resources. Such report shall include a description and 
        analysis, by age, sex, income, and geographic area, of 
        the statistics collected under section 306(b)(1)(F).
            (D) A report on the health of the Nation's people. 
        Such report shall include a description and analysis, 
        by age, sex, income, and geographic area, of the 
        statistics collected under section 306(b)(1)(A).
    (2) The reports required in paragraph (1) shall be prepared 
through the National Center for Health Statistics.
    (3) The Office of Management and Budget may review any 
report required by paragraph (1) of this subsection before its 
submission to Congress, but the Office may not revise any such 
report or delay its submission beyond the date prescribed for 
its submission, and may submit to Congress its comments 
respecting any such report.
    (b)(1) No grant or contract may be made under section 304, 
306, or 307 unless an application therefor has been submitted 
to the Secretary in such form and manner, and containing such 
information, as the Secretary may by regulation prescribe and 
unless a peer review group referred to in paragraph (2) has 
recommended the application for approval.
    (2)(A) Each application submitted for a grant or contract 
under section 306 in an amount exceeding $50,000 of direct 
costs and for a health services research, evaluation, or 
demonstration project, or for a grant under section 306(m), 
shall be submitted to a peer review group for an evaluation of 
the technical and scientific merits of the proposals made in 
each such application. The Director of the National Center for 
Health Statistics shall establish such peer review groups as 
may be necessary to provide for such an evaluation of each such 
application.
    (B) A peer review group to which an application is 
submitted pursuant to subparagraph (A) shall report its finding 
and recommendations respecting the application to the 
Secretary, acting through the Director of the National Center 
for Health Statistics, in such form and manner as the Secretary 
shall by regulation prescribe. The Secretary may not approve an 
application described in such subparagraph unless a peer review 
group has recommended the application for approval.
    (C) The Secretary, acting through the Director of the 
National Center for Health Statistics, shall make appointments 
to the peer review groups required in subparagraph (A) from 
among persons who are not officers or employees of the United 
States and who possess appropriate technical and scientific 
qualifications, except that peer review groups regarding grants 
under section 306(m) may include appropriately qualified such 
officers and employees.
    (c) The Secretary shall take such action as may be 
necessary to assure that statistics developed under sections 
304 and 306 are of high quality, timely, comprehensive as well 
as specific, standardized, and adequately analyzed and indexed, 
and shall publish, make available, and disseminate such 
statistics on as wide a basis as is practicable.
    (d) No information, if an establishment or person supplying 
the information or described in it is identifiable, obtained in 
the course of activities undertaken or supported under section 
304, 306, or 307 may be used for any purpose other than the 
purpose for which it was supplied unless such establishment or 
person has consented (as determined under regulations of the 
Secretary) to its use for such other purpose and in the case of 
information obtained in the course of health statistical or 
epidemiological activities under section 304 or 306, such 
information may not be published or released in other form if 
the particular establishment or person supplying the 
information or described in it is identifiable unless such 
establishment or person has consented (as determined under 
regulations of the Secretary) to its publication or release in 
other form.
    (e)(1) Payments of any grant or under any contract under 
section 304, 306, or 307 may be made in advance or by way of 
reimbursement, and in such installments and on such conditions, 
as the Secretary deems necessary to carry out the purposes of 
such section.
    (2) The amounts otherwise payable to any person under a 
grant or contract made under section 304, 306, or 307 shall be 
reduced by--
            (A) amounts equal to the fair market value of any 
        equipment or supplies furnished to such person by the 
        Secretary for the purpose of carrying out the project 
        with respect to which such grant or contract is made, 
        and
            (B) amounts equal to the pay, allowances, traveling 
        expenses, and related personnel expenses attributable 
        to the performance of services by an officer or 
        employee of the Government in connection with such 
        project, if such officer or employee was assigned or 
        detailed by the Secretary to perform such services,
but only if such person requested the Secretary to furnish such 
equipment or supplies, or such services, as the case may be.
    (f) Contracts may be entered into under section 304 or 306 
without regard to section 3324 of title 31, United States Code, 
and section 3709 of the Revised Statutes (41 U.S.C. 5).
          health conferences and health education information
    Sec. 310. \1\ [242o] (a) A conference of the health 
authorities in and among the several States shall be called 
annually by the Secretary. Whenever in his opinion the 
interests of the public health would be promoted by a 
conference, the Secretary may invite as many of such health 
authorities and officials of other State or local public or 
private agencies, institutions, or organizations to confer as 
he deems necessary or proper. Upon the application of health 
authorities of five or more States it shall be the duty of the 
Secretary to call a conference of all State health authorities 
joining in the request. Each State represented at any 
conference shall be entitled to a single vote. Whenever at any 
such conference matters relating to mental health are to be 
discussed, the mental health authorities of the respective 
States shall be invited to attend.
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    \1\ Former section 309 was repealed by section 6103(d)(1)(B) of 
Public Law 101-239 (103 Stat. 2205).
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    (b) From time to time the Secretary shall issue information 
related to public health, in the form of publications or 
otherwise, for the use of the public, and shall publish weekly 
reports of health conditions in the United States and other 
countries and other pertinent health information for the use of 
persons and institutions concerned with health services.

SEC. 310A. [242S] CENTERS FOR DISEASE CONTROL AND PREVENTION OFFICE OF 
                    WOMEN'S HEALTH.

    (a) Establishment.--There is established within the Office 
of the Director of the Centers for Disease Control and 
Prevention, an office to be known as the Office of Women's 
Health (referred to in this section as the ``Office''). The 
Office shall be headed by a director who shall be appointed by 
the Director of such Centers.
    (b) Purpose.--The Director of the Office shall--
            (1) report to the Director of the Centers for 
        Disease Control and Prevention on the current level of 
        the Centers' activity regarding women's health 
        conditions across, where appropriate, age, biological, 
        and sociocultural contexts, in all aspects of the 
        Centers' work, including prevention programs, public 
        and professional education, services, and treatment;
            (2) establish short-range and long-range goals and 
        objectives within the Centers for women's health and, 
        as relevant and appropriate, coordinate with other 
        appropriate offices on activities within the Centers 
        that relate to prevention, research, education and 
        training, service delivery, and policy development, for 
        issues of particular concern to women;
            (3) identify projects in women's health that should 
        be conducted or supported by the Centers;
            (4) consult with health professionals, 
        nongovernmental organizations, consumer organizations, 
        women's health professionals, and other individuals and 
        groups, as appropriate, on the policy of the Centers 
        with regard to women; and
            (5) serve as a member of the Department of Health 
        and Human Services Coordinating Committee on Women's 
        Health (established under section 229(b)(4)).
    (c) Definition.--As used in this section, the term 
``women's health conditions'', with respect to women of all 
age, ethnic, and racial groups, means diseases, disorders, and 
conditions--
            (1) unique to, significantly more serious for, or 
        significantly more prevalent in women; and
            (2) for which the factors of medical risk or type 
        of medical intervention are different for women, or for 
        which there is reasonable evidence that indicates that 
        such factors or types may be different for women.
    (d) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2010 through 2014.

                   Part B--Federal-State Cooperation

                               in general

    Sec. 311. [243] (a) The Secretary is authorized to accept 
from State and local authorities any assistance in the 
enforcement of quarantine regulations made pursuant to this Act 
which such authorities may be able and willing to provide. The 
Secretary shall also assist States and their political 
subdivisions in the prevention and suppression of communicable 
diseases and with respect to other public health matters, shall 
cooperate with and aid State and local authorities in the 
enforcement of their quarantine and other health regulations, 
and shall advise the several States on matters relating to the 
preservation and improvement of the public health.
    (b) The Secretary shall encourage cooperative activities 
between the States with respect to comprehensive and continuing 
planning as to their current and future health needs, the 
establishment and maintenance of adequate public health 
services, and otherwise carrying out the public health 
activities. The Secretary is also authorized to train personnel 
for State and local health work. The Secretary may charge only 
private entities reasonable fees for the training of their 
personnel under the preceding sentence.
    (c)(1) The Secretary is authorized to develop (and may take 
such action as may be necessary to implement) a plan under 
which personnel, equipment, medical supplies, and other 
resources of the Service and other agencies under the 
jurisdiction of the Secretary may be effectively used to 
control epidemics of any disease or condition and to meet other 
health emergencies or problems. The Secretary may enter into 
agreements providing for the cooperative planning between the 
Service and public and private community health programs and 
agencies to cope with health problems (including epidemics and 
health emergencies).
    (2) The Secretary may, at the request of the appropriate 
State or local authority, extend temporary (not in excess of 
six months) assistance to States or localities in meeting 
health emergencies of such a nature as to warrant Federal 
assistance. The Secretary may require such reimbursement of the 
United States for assistance provided under this paragraph as 
he may determine to be reasonable under the circumstances. Any 
reimbursement so paid shall be credited to the applicable 
appropriation for the Service for the year in which such 
reimbursement is received.

SEC. 312. [244] PUBLIC ACCESS DEFIBRILLATION PROGRAMS.

    (a) In General.--The Secretary shall award grants to 
States, political subdivisions of States, Indian tribes, and 
tribal organizations to develop and implement public access 
defibrillation programs--
            (1) by training and equipping local emergency 
        medical services personnel, including firefighters, 
        police officers, paramedics, emergency medical 
        technicians, and other first responders, to administer 
        immediate care, including cardiopulmonary resuscitation 
        and automated external defibrillation, to cardiac 
        arrest victims;
            (2) by purchasing automated external 
        defibrillators, placing the defibrillators in public 
        places where cardiac arrests are likely to occur, and 
        training personnel in such places to administer 
        cardiopulmonary resuscitation and automated external 
        defibrillation to cardiac arrest victims;
            (3) by setting procedures for proper maintenance 
        and testing of such devices, according to the 
        guidelines of the manufacturers of the devices;
            (4) by providing training to members of the public 
        in cardiopulmonary resuscitation and automated external 
        defibrillation;
            (5) by integrating the emergency medical services 
        system with the public access defibrillation programs 
        so that emergency medical services personnel, including 
        dispatchers, are informed about the location of 
        automated external defibrillators in their community; 
        and
            (6) by encouraging private companies, including 
        small businesses, to purchase automated external 
        defibrillators and provide training for their employees 
        to administer cardiopulmonary resuscitation and 
        external automated defibrillation to cardiac arrest 
        victims in their community.
    (b) Preference.--In awarding grants under subsection (a), 
the Secretary shall give a preference to a State, political 
subdivision of a State, Indian tribe, or tribal organization 
that--
            (1) has a particularly low local survival rate for 
        cardiac arrests, or a particularly low local response 
        rate for cardiac arrest victims; or
            (2) demonstrates in its application the greatest 
        commitment to establishing and maintaining a public 
        access defibrillation program.
    (c) Use of Funds.--A State, political subdivision of a 
State, Indian tribe, or tribal organization that receives a 
grant under subsection (a) may use funds received through such 
grant to--
            (1) purchase automated external defibrillators that 
        have been approved, or cleared for marketing, by the 
        Food and Drug Administration;
            (2) provide automated external defibrillation and 
        basic life support training in automated external 
        defibrillator usage through nationally recognized 
        courses;
            (3) provide information to community members about 
        the public access defibrillation program to be funded 
        with the grant;
            (4) provide information to the local emergency 
        medical services system regarding the placement of 
        automated external defibrillators in public places;
            (5) produce materials to encourage private 
        companies, including small businesses, to purchase 
        automated external defibrillators;
            (6) establish an information clearinghouse, that 
        shall be administered by an organization that has 
        substantial expertise in pediatric education, pediatric 
        medicine, and electrophysiology and sudden death, that 
        provides information to increase public access to 
        defibrillation in schools; and
            (7) further develop strategies to improve access to 
        automated external defibrillators in public places.
    (d) Application.--
            (1) In general.--To be eligible to receive a grant 
        under subsection (a), a State, political subdivision of 
        a State, Indian tribe, or tribal organization shall 
        prepare and submit an application to the Secretary at 
        such time, in such manner, and containing such 
        information as the Secretary may reasonably require.
            (2) Contents.--An application submitted under 
        paragraph (1) shall--
                    (A) describe the comprehensive public 
                access defibrillation program to be funded with 
                the grant and demonstrate how such program 
                would make automated external defibrillation 
                accessible and available to cardiac arrest 
                victims in the community;
                    (B) contain procedures for implementing 
                appropriate nationally recognized training 
                courses in performing cardiopulmonary 
                resuscitation and the use of automated external 
                defibrillators;
                    (C) contain procedures for ensuring direct 
                involvement of a licensed medical professional 
                and coordination with the local emergency 
                medical services system in the oversight of 
                training and notification of incidents of the 
                use of the automated external defibrillators;
                    (D) contain procedures for proper 
                maintenance and testing of the automated 
                external defibrillators, according to the 
                labeling of the manufacturer;
                    (E) contain procedures for ensuring 
                notification of local emergency medical 
                services system personnel, including 
                dispatchers, of the location and type of 
                devices used in the public access 
                defibrillation program; and
                    (F) provide for the collection of data 
                regarding the effectiveness of the public 
                access defibrillation program to be funded with 
                the grant in affecting the out-of-hospital 
                cardiac arrest survival rate.
    (e) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated $25,000,000 for for \1\ each of fiscal years 2003 
through 2014. Not more than 10 percent of amounts received 
under a grant awarded under this section may be used for 
administrative expenses.
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    \1\ The words ``for for'' so in law.
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SEC. 313. [245] PUBLIC ACCESS DEFIBRILLATION DEMONSTRATION PROJECTS.

    (a) In General.--The Secretary shall award grants to 
political subdivisions of States, Indian tribes, and tribal 
organizations to develop and implement innovative, 
comprehensive, community-based public access defibrillation 
demonstration projects that--
            (1) provide cardiopulmonary resuscitation and 
        automated external defibrillation to cardiac arrest 
        victims in unique settings;
            (2) provide training to community members in 
        cardiopulmonary resuscitation and automated external 
        defibrillation; and
            (3) maximize community access to automated external 
        defibrillators.
    (b) Use of Funds.--A recipient of a grant under subsection 
(a) shall use the funds provided through the grant to--
            (1) purchase automated external defibrillators that 
        have been approved, or cleared for marketing, by the 
        Food and Drug Administration;
            (2) provide basic life training in automated 
        external defibrillator usage through nationally 
        recognized courses;
            (3) provide information to community members about 
        the public access defibrillation demonstration project 
        to be funded with the grant;
            (4) provide information to the local emergency 
        medical services system regarding the placement of 
        automated external defibrillators in the unique 
        settings; and
            (5) further develop strategies to improve access to 
        automated external defibrillators in public places.
    (c) Application.--
            (1) In general.--To be eligible to receive a grant 
        under subsection (a), a political subdivision of a 
        State, Indian tribe, or tribal organization shall 
        prepare and submit an application to the Secretary at 
        such time, in such manner, and containing such 
        information as the Secretary may reasonably require.
            (2) Contents.--An application submitted under 
        paragraph (1) may--
                    (A) describe the innovative, comprehensive, 
                community-based public access defibrillation 
                demonstration project to be funded with the 
                grant;
                    (B) explain how such public access 
                defibrillation demonstration project represents 
                innovation in providing public access to 
                automated external defibrillation; and
                    (C) provide for the collection of data 
                regarding the effectiveness of the 
                demonstration project to be funded with the 
                grant in--
                            (i) providing emergency 
                        cardiopulmonary resuscitation and 
                        automated external defibrillation to 
                        cardiac arrest victims in the setting 
                        served by the demonstration project; 
                        and
                            (ii) affecting the cardiac arrest 
                        survival rate in the setting served by 
                        the demonstration project.
    (d) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section $5,000,000 for 
each of fiscal years 2002 through 2006. Not more than 10 
percent of amounts received under a grant awarded under this 
section may be used for administrative expenses.
  grants for comprehensive health planning and public health services

        Grants to States for Comprehensive State Health Planning

    Sec. 314. [246] (a)(1) Authorization.--In order to assist 
the States in comprehensive and continuing planning for their 
current and future health needs, the Secretary is authorized 
during the period beginning July 1, 1966, and ending June 30, 
1973, to make grants to States which have submitted, and had 
approved by the Secretary, State plans for comprehensive State 
health planning. For the purposes of carrying out this 
subsection, there are hereby authorized to be appropriated 
$2,500,000 for the fiscal year ending June 30, 1967, $7,000,000 
for the fiscal year ending June 30, 1968, $10,000,000 for the 
fiscal year ending June 30, 1969, $15,000,000 for the fiscal 
year ending June 30, 1970, $15,000,000 for the fiscal year 
ending June 30, 1971, $17,000,000 for the fiscal year ending 
June 30, 1972, $20,000,000 for the fiscal year ending June 30, 
1973, and $10,000,000 for the fiscal year ending June 30, 1974.
    (2) State Plans for Comprehensive State Health Planning.--
In order to be approved for purposes of this subsection, a 
State plan for comprehensive State health planning must--
            (A) designate, or provide for the establishment of, 
        a single State agency, which may be an 
        interdepartmental agency, as the sole agency for 
        administering or supervising the administration of the 
        State's health planning functions under the plan;
            (B) provide for the establishment of a State health 
        planning council, which shall include representatives 
        of Federal, State, and local agencies (including as an 
        ex officio member, if there is located in such State 
        one or more hospitals or other health care facilities 
        of the Department of Veterans Affairs, the individual 
        whom the Secretary of Veterans Affairs shall have 
        designated to serve on such council as the 
        representative of the hospitals or other health care 
        facilities of such Department which are located in such 
        State) and nongovernmental organizations and groups 
        concerned with health (including representation of the 
        regional medical program or programs included in whole 
        or in part within the State) and of consumers of health 
        services, to advise such State agency in carrying out 
        its functions under the plan, and a majority of the 
        membership of such council shall consist of 
        representatives of consumers of health services;
            (C) set forth policies and procedures for the 
        expenditure of funds under the plan, which, in the 
        judgment of the Secretary, are designed to provide for 
        comprehensive State planning for health services (both 
        public and private and including home health care), 
        including the facilities and persons required for the 
        provision of such services, to meet the health needs of 
        the people of the State and including environmental 
        considerations as they relate to public health;
            (D) provide for encouraging cooperative efforts 
        among governmental or nongovernmental agencies, 
        organizations and groups concerned with health 
        services, facilities, or manpower, and for cooperative 
        efforts between such agencies, organizations, and 
        groups and similar agencies, organizations, and groups 
        in the fields of education, welfare, and 
        rehabilitation;
            (E) contain or be supported by assurances 
        satisfactory to the Secretary that the funds paid under 
        this subsection will be used to supplement and, to the 
        extent practicable, to increase the level of funds that 
        would otherwise be made available by the State for the 
        purpose of comprehensive health planning and not to 
        supplant such non-Federal funds;
            (F) \1\ provide such methods of administration 
        (including methods relating to the establishment and 
        maintenance of personnel standards on a merit basis, 
        except that the Secretary shall exercise no authority 
        with respect to the selection, tenure of office, and 
        compensation of any individual employed in accordance 
        with such methods) as are found by the Secretary to be 
        necessary for the proper and efficient operation of the 
        plan;
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    \1\ Section 208(a)(3) of Public Law 91-648 (42 U.S.C. 4728) 
transferred to the United States Civil Service Commission all 
functions, powers, and duties of the Secretary under any law applicable 
to a grant program which requires the establishment and maintenance of 
personnel standards on a merit basis with respect to the program. 
Reorganization Plan No. 2 of 1978 (42 U.S.C. 1101 note) transferred to 
the Office of Personnel Management all functions of the United States 
Civil Service Commission.
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            (G) provide that the State agency will make such 
        reports, in such form and containing such information, 
        as the Secretary may from time to time reasonably 
        require, and will keep such records and afford such 
        access thereto as the Secretary finds necessary to 
        assure the correctness and verification of such 
        reports;
            (H) provide that the State agency will from time to 
        time, but not less often than annually, review its 
        State plan approved under this subsection and submit to 
        the Secretary appropriate modifications thereof;
            (I) effective July 1, 1968, (i) provide for 
        assisting each health care facility in the State to 
        develop a program for capital expenditures for 
        replacement, modernization, and expansion which is 
        consistent with an overall State plan developed in 
        accordance with criteria established by the Secretary 
        after consultation with the State which will meet the 
        needs of the State for health care facilities, 
        equipment, and services without duplication and 
        otherwise in the most efficient and economical manner, 
        and (ii) provide that the State agency furnishing such 
        assistance will periodically review the program 
        (developed pursuant to clause (i)) of each health care 
        facility in the State and recommended appropriate 
        modification thereof;
            (J) provide for such fiscal control and fund 
        accounting procedures as may be necessary to assure 
        proper disbursement of and accounting for funds paid to 
        the State under this subsection; and
            (K) contain such additional information and 
        assurances as the Secretary may find necessary to carry 
        out the purposes of this subsection.
    (3)(A) State Allotments.--From the sums appropriated for 
such purpose for each fiscal year, the several States shall be 
entitled to allotments determined, in accordance with 
regulations, on the basis of the population and the per capita 
income of the respective States; except that no such allotment 
to any State for any fiscal year shall be less than 1 per 
centum of the sum appropriated for such fiscal year pursuant to 
paragraph (1). Any such allotment to a State for a fiscal year 
shall remain available for obligation by the State, in 
accordance with the provisions of this subsection and the 
State's plan approved thereunder, until the close of the 
succeeding fiscal year.
    (B) The amount of any allotment to a State under 
subparagraph (A) for any fiscal year which the Secretary 
determines will not be required by the State, during the period 
for which it is available, for the purposes for which allotted 
shall be available for reallotment by the Secretary from time 
to time, on such date or dates as he may fix, to other States 
with respect to which such a determination has not been made, 
in proportion to the original allotments to such States under 
subparagraph (A) for such fiscal year, but with such 
proportionate amount for any of such other States being reduced 
to the extent it exceeds the sum the Secretary estimates such 
State needs and will be able to use during such period; and the 
total of such reductions shall be similarly reallotted among 
the States whose proportionate amounts were not so reduced. Any 
amount so reallotted to a State from funds appropriated 
pursuant to this subsection for a fiscal year shall be deemed 
part of its allotment under subparagraph (A) for such fiscal 
year.
    (4) Payments to States.--From each State's allotment for a 
fiscal year under this subsection, the State shall from time to 
time be paid the Federal share of the expenditures incurred 
during that year or the succeeding year pursuant to its State 
plan approved under this subsection. Such payments shall be 
made on the basis of estimates by the Secretary of the sums the 
State will need in order to perform the planning under its 
approved State plan under this subsection, but with such 
adjustments as may be necessary to take account of previously 
made underpayments or overpayments. The ``Federal share'' for 
any State for purposes of this subsection shall be all, or such 
part as the Secretary may determine, of the cost of such 
planning, except that in the case of the allotments for the 
fiscal year ending June 30, 1970, it shall not exceed 75 per 
centum, of such cost.

              Project Grants for Areawide Health Planning

    (b)(1)(A) The Secretary is authorized, during the period 
beginning July 1, 1966, and ending June 30, 1974, to make, with 
the approval of the State agency administering or supervising 
the administration of the State plan approved under subsection 
(a), project grants to any other public or nonprofit private 
agency or organization (but with appropriate representation of 
the interests of local government where the recipient of the 
grant is not a local government or combination thereof or an 
agency of such government or combination) to cover not to 
exceed 75 per centum of the costs of projects for developing 
(and from time to time revising) comprehensive regional, 
metropolitan area, or other local area plans for coordination 
of existing and planned health services, including the 
facilities and persons required for provision of such services; 
and including the provision of such services through home 
health care; except that in the case of project grants made in 
any State prior to July 1, 1968, approval of such State agency 
shall be required only if such State has such a State plan in 
effect at the time of such grants. No grant may be made under 
this subsection after June 30, 1970, to any agency or 
organization to develop or revise health plans for an area 
unless the Secretary determines that such agency or 
organization provides means for appropriate representation of 
the interests of the hospitals, other health care facilities, 
and practicing physicians serving such area, and the general 
public. For the purposes of carrying out this subsection, there 
are hereby authorized to be appropriated $5,000,000 for the 
fiscal year ending June 30, 1967, $7,500,000 for the fiscal 
year ending June 30, 1968, $10,000,000 for the fiscal year 
ending June 30, 1969, $15,000,000 for the fiscal year ending 
June 30, 1970, $20,000,000 for the fiscal year ending June 30, 
1971, $30,000,000 for the fiscal year ending June 30, 1972, 
$40,000,000 for the fiscal year ending June 30, 1973, and 
$25,100,000 for the fiscal year ending June 30, 1974.
    (B) Project grants may be made by the Secretary under 
subparagraph (A) to the State agency administering or 
supervising the administration of the State plan approved under 
subsection (a) with respect to a particular region or area, but 
only if (i) no application for such a grant with respect to 
such region or area has been filed by any other agency or 
organization qualified to receive such a grant, and (ii) such 
State agency certifies, and the Secretary finds, that ample 
opportunity has been afforded to qualified agencies and 
organizations to file application for such a grant with respect 
to such region or area and that it is improbable that, in the 
foresee-able future, any agency or organization which is 
qualified for such a grant will file application therefor.
    (2)(A) In order to be approved under this subsection, an 
application for a grant under this subsection must contain or 
be supported by reasonable assurances that there has been or 
will be established, in or for the area with respect to which 
such grant is sought, an areawide health planning council. The 
membership of such council shall include representatives of 
public, voluntary, and non-profit private agencies, 
institutions, and organizations concerned with health 
(including representatives of the interests of local government 
of the regional medical program for such area, and of consumers 
of health services). A majority of the members of such council 
shall consist of representatives of consumers of health 
services.
    (B) In addition, an application for a grant under this 
subsection must contain or be supported by reasonable 
assurances that the areawide health planning agency has made 
provision for assisting health care facilities in its area to 
develop a program for capital expenditures for replacement, 
modernization, and expansion, which is consistent with an 
overall State plan which will meet the needs of the State and 
the area for health care facilities, equipment, and services 
without duplication and otherwise in the most efficient and 
economical manner.

        Project Grants for Training, Studies, and Demonstrations

    (c) The Secretary is also authorized, during the period 
beginning July 1, 1966, and ending June 30, 1974, to make 
grants to any public or nonprofit private agency, institution, 
or other organization to cover all or any part of the cost of 
projects for training, studies, or demonstrations looking 
toward the development of improved or more effective 
comprehensive health planning throughout the Nation. For the 
purposes of carrying out this subsection, there are hereby 
authorized to be appropriated $1,500,000 for the fiscal year 
ending June 30, 1967, $2,500,000 for the fiscal year ending 
June 30, 1968, $5,000,000 for the fiscal year ending June 30, 
1969, $7,500,000 for the fiscal year ending June 30, 1970, 
$8,000,000 for the fiscal year ending June 30, 1971, 
$10,000,000 for the fiscal year ending June 30, 1972, 
$12,000,000 for the fiscal year ending June 30, 1973, and 
$4,700,000 for the fiscal year ending June 30, 1974.

         family support groups for alzheimer's disease patients

      Sec. 316. \1\ [247a] (a) Subject to available 
appropriations, the Secretary, acting through the National 
Institute of Mental Health, the National Institutes of Health, 
and the Administration on Aging, shall promote the 
establishment of family support groups to provide, without 
charge, educational, emotional, and practical support to assist 
individuals with Alzheimer's disease or a related memory 
disorder and members of the families of such individuals. In 
promoting the establishment of such groups, the Secretary shall 
give priority to--
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    \1\ With respect to section 315, subsection (d) of such section 
provided as follows: ``This section shall cease to exist on March 31, 
1989.''. See section 1 of Public Law 100-471 (102 Stat. 2284).
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            (1) university medical centers and other 
        appropriate health care facilities which receive 
        Federal funds from the Secretary and which conduct 
        research on Alzheimer's disease or provide services to 
        individuals with such disease; and
            (2) community-based programs which receive funds 
        from the Secretary, acting through the Administration 
        on Aging.
      (b) The Secretary shall promote the establishment of a 
national network to coordinate the family support groups 
described in subsection (a).

             project grants for preventive health services

    Sec. 317. [247b] (a) The Secretary may make grants to 
States, and in consultation with State health authorities, to 
political subdivisions of States and to other public entities 
to assist them in meeting the costs of establishing and 
maintaining preventive health service programs.
    (b) No grant may be made under subsection (a) unless an 
application therefor has been submitted to, and approved by, 
the Secretary. Such an application shall be in such form and be 
submitted in such manner as the Secretary shall by regulation 
prescribe and shall provide--
            (1) a complete description of the type and extent 
        of the program for which the applicant is seeking a 
        grant under subsection (a);
            (2) with respect to each such program (A) the 
        amount of Federal, State, and other funds obligated by 
        the applicant in its latest annual accounting period 
        for the provision of such program, (B) a description of 
        the services provided by the applicant in such program 
        in such period, (C) the amount of Federal funds needed 
        by the applicant to continue providing such services in 
        such program, and (D) if the applicant proposes changes 
        in the provision of the services in such program, the 
        priorities of such proposed changes, reasons for such 
        changes, and the amount of Federal funds needed by the 
        applicant to make such changes;
            (3) assurances satisfactory to the Secretary that 
        the program which will be provided with funds under a 
        grant under subsection (a) will be provided in a manner 
        consistent with the State health plan in effect under 
        section 1524(c) and in those cases where the applicant 
        is a State, that such program will be provided, where 
        appropriate, in a manner consistent with any plans in 
        effect under an application approved under section 315;
            (4) assurances satisfactory to the Secretary that 
        the applicant will provide for such fiscal control and 
        fund accounting procedures as the Secretary by 
        regulation prescribes to assure the proper disbursement 
        of and accounting for funds received under grants under 
        subsection (a);
            (5) assurances satisfactory to the Secretary that 
        the applicant will provide for periodic evaluation of 
        its program or programs;
            (6) assurances satisfactory to the Secretary that 
        the applicant will make such reports (in such form and 
        containing such information as the Secretary may by 
        regulation prescribe) as the Secretary may reasonably 
        require and keep such records and afford such access 
        thereto as the Secretary may find necessary to assure 
        the correctness of, and to verify, such reports;
            (7) assurances satisfactory to the Secretary that 
        the applicant will comply with any other conditions 
        imposed by this section with respect to grants; and
            (8) such other information as the Secretary may by 
        regulation prescribe.
    (c)(1) The Secretary shall not approve an application 
submitted under subsection (b) for a grant for a program for 
which a grant was previously made under subsection (a) unless 
the Secretary determines--
            (A) the program for which the application was 
        submitted is operating effectively to achieve its 
        stated purpose,
            (B) the applicant complied with the assurances 
        provided the Secretary when applying for such previous 
        grant, and
            (C) the applicant will comply with the assurances 
        provided with the application.
    (2) The Secretary shall review annually the activities 
undertaken by each recipient of a grant under subsection (a) to 
determine if the program assisted by such grant is operating 
effectively to achieve its stated purposes and if the recipient 
is in compliance with the assurances provided the Secretary 
when applying for such grant.
    (d) The amount of a grant under subsection (a) shall be 
determined by the Secretary. Payments under such grants may be 
made in advance on the basis of estimates or by the way of 
reimbursement, with necessary adjustments on account of 
underpayments or overpayments, and in such installments and on 
such terms and conditions as the Secretary finds necessary to 
carry out the purposes of such grants.
    (e) The Secretary, at the request of a recipient of a grant 
under subsection (a), may reduce the amount of such grant by--
            (1) the fair market value of any supplies 
        (including vaccines and other preventive agents) or 
        equipment furnished the grant recipient, and
            (2) the amount of the pay, allowances, and travel 
        expenses of any officer or employee of the Government 
        when detailed to the grant recipient and the amount of 
        any other costs incurred in connection with the detail 
        of such officer or employee.
When the furnishing of such supplies or equipment or the detail 
of such an officer or employee is for the convenience of and at 
the request of such grant recipient and for the purpose of 
carrying out a program with respect to which the grant under 
subsection (a) is made. The amount by which any such grant is 
so reduced shall be available for payment by the Secretary of 
the costs incurred in furnishing the supplies or equipment, or 
in detailing the personnel, on which the reduction of such 
grant is based, and such amount shall be deemed as part of the 
grant and shall be deemed to have been paid to the grant 
recipient.
    (f)(1) Each recipient of a grant under subsection (a) shall 
keep such records as the Secretary shall by regulation 
prescribe, including records which fully disclose the amount 
and disposition by such recipient of the proceeds of such 
grant, the total cost of the undertaking in connection with 
which such grant was made, and the amount of that portion of 
the cost of the undertaking supplied by other sources, and such 
other records as will facilitate an effective audit.
    (2) The Secretary and the Comptroller General of the United 
States, or any of their duly authorized representatives, shall 
have access for the purpose of audit and examination to any 
books, documents, papers, and records of the recipient of 
grants under subsection (a) that are pertinent to such grants.
    (g)(1) Nothing in this section shall limit or otherwise 
restrict the use of funds which are granted to a State or to an 
agency or a political subdivision of a State under provisions 
of Federal law (other than this section) and which are 
available for the conduct of preventive health service programs 
from being used on connection with programs assisted through 
grants under subsection (a).
    (2) Nothing in this section shall be construed to require 
any State or any agency or political subdivision of a State to 
have a preventive health service program which would require 
any person, who objects to any treatment provided under such a 
program, to be treated or to have any child or ward treated 
under such program.
    (h) The Secretary shall include, as part of the report 
required by section 1705, a report on the extent of the 
problems presented by the diseases and conditions referred to 
in subsection (j) on the amount of funds obligated under grants 
under subsection (a) in the preceding fiscal year for each of 
the programs listed in subsection (j); and on the effectiveness 
of the activities assisted under grants under subsection (a) in 
controlling such diseases and conditions.
    (i) The Secretary may provide technical assistance to 
States, State health authorities, and other public entities in 
connection with the operation of their preventive health 
service programs.
    (j)(1) Except for grants for immunization programs the 
authorization of appropriations for which are established in 
paragraph (2), for grants under subsections (a) and (k)(1) for 
preventive health service programs to immunize without charge 
children, adolescents, and adults against vaccine-preventable 
diseases, there are authorized to be appropriated such sums as 
may be necessary. Not more than 10 percent ot the total amount 
appropriated under the preceding sentence for any fiscal year 
shall be available for grants under subsection (k)(1) for such 
fiscal year.
    (2) For grants under subsection (a) for preventive health 
service programs for the provision without charge of 
immunizations with vaccines approved for use, and recommended 
for routine use, there are authorized to be appropriated such 
sums as may be necessary.
    (k)(1) The Secretary may make grants to States, political 
subdivisions of States, and other public and nonprofit private 
entities for--
            (A) research into the prevention and control of 
        diseases that may be prevented through vaccination;
            (B) demonstration projects for the prevention and 
        control of such diseases;
            (C) public information and education programs for 
        the prevention and control of such diseases; and
            (D) education, training, and clinical skills 
        improvement activities in the prevention and control of 
        such diseases for health professionals (including 
        allied health personnel).
    (2) The Secretary may make grants to States, political 
subdivisions of States, and other public and nonprofit private 
entities for--
            (A) research into the prevention and control of 
        diseases and conditions;
            (B) demonstration projects for the prevention and 
        control of such diseases and conditions;
            (C) public information and education programs for 
        the prevention and control of such diseases and 
        conditions; and
            (D) education, training, and clinical skills 
        improvement activities in the prevention and control of 
        such diseases and conditions for health professionals 
        (including allied health personnel).
    (3) No grant may be made under this subsection unless an 
application therefor is submitted to the Secretary in such 
form, at such time, and containing such information as the 
Secretary may by regulation prescribe.
    (4) Subsections (d), (e), and (f) shall apply to grants 
under this subsection in the same manner as such subsections 
apply to grants under subsection (a).
    (l) Authority to Purchase Recommended Vaccines for 
Adults.--
            (1) In general.--The Secretary may negotiate and 
        enter into contracts with manufacturers of vaccines for 
        the purchase and delivery of vaccines for adults as 
        provided for under subsection (e).
            (2) State purchase.--A State may obtain additional 
        quantities of such adult vaccines (subject to amounts 
        specified to the Secretary by the State in advance of 
        negotiations) through the purchase of vaccines from 
        manufacturers at the applicable price negotiated by the 
        Secretary under this subsection.
    (m) Demonstration Program To Improve Immunization 
Coverage.--
            (1) In general.--The Secretary, acting through the 
        Director of the Centers for Disease Control and 
        Prevention, shall establish a demonstration program to 
        award grants to States to improve the provision of 
        recommended immunizations for children, adolescents, 
        and adults through the use of evidence-based, 
        population-based interventions for high-risk 
        populations.
            (2) State plan.--To be eligible for a grant under 
        paragraph (1), a State shall submit to the Secretary an 
        application at such time, in such manner, and 
        containing such information as the Secretary may 
        require, including a State plan that describes the 
        interventions to be implemented under the grant and how 
        such interventions match with local needs and 
        capabilities, as determined through consultation with 
        local authorities.
            (3) Use of funds.--Funds received under a grant 
        under this subsection shall be used to implement 
        interventions that are recommended by the Task Force on 
        Community Preventive Services (as established by the 
        Secretary, acting through the Director of the Centers 
        for Disease Control and Prevention) or other evidence-
        based interventions, including--
                    (A) providing immunization reminders or 
                recalls for target populations of clients, 
                patients, and consumers;
                    (B) educating targeted populations and 
                health care providers concerning immunizations 
                in combination with one or more other 
                interventions;
                    (C) reducing out-of-pocket costs for 
                families for vaccines and their administration;
                    (D) carrying out immunization-promoting 
                strategies for participants or clients of 
                public programs, including assessments of 
                immunization status, referrals to health care 
                providers, education, provision of on-site 
                immunizations, or incentives for immunization;
                    (E) providing for home visits that promote 
                immunization through education, assessments of 
                need, referrals, provision of immunizations, or 
                other services;
                    (F) providing reminders or recalls for 
                immunization providers;
                    (G) conducting assessments of, and 
                providing feedback to, immunization providers;
                    (H) any combination of one or more 
                interventions described in this paragraph; or
                    (I) immunization information systems to 
                allow all States to have electronic databases 
                for immunization records.
            (4) Consideration.--In awarding grants under this 
        subsection, the Secretary shall consider any reviews or 
        recommendations of the Task Force on Community 
        Preventive Services.
            (5) Evaluation.--Not later than 3 years after the 
        date on which a State receives a grant under this 
        subsection, the State shall submit to the Secretary an 
        evaluation of progress made toward improving 
        immunization coverage rates among high-risk populations 
        within the State.
            (6) Report to congress.--Not later than 4 years 
        after the date of enactment of the Affordable Health 
        Choices Act, the Secretary shall submit to Congress a 
        report concerning the effectiveness of the 
        demonstration program established under this subsection 
        together with recommendations on whether to continue 
        and expand such program.
            (7) Authorization of appropriations.--There is 
        authorized to be appropriated to carry out this 
        subsection, such sums as may be necessary for each of 
        fiscal years 2010 through 2014.
     screenings, referrals, and education regarding lead poisoning
    Sec. 317A. [247b-1] (a) Authority for Grants.--
            (1) In general.--Subject to paragraph (2), the 
        Secretary, acting through the Director of the Centers 
        for Disease Control and Prevention, may make grants to 
        States and political subdivisions of States for the 
        initiation and expansion of community programs 
        designed--
                    (A) to provide, for infants and children--
                            (i) screening for elevated blood 
                        lead levels;
                            (ii) referral for treatment of such 
                        levels; and
                            (iii) referral for environmental 
                        intervention associated with such 
                        levels; and
                    (B) to provide education about childhood 
                lead poisoning.
            (2) Authority regarding certain entities.--With 
        respect to a geographic area with a need for activities 
        authorized in paragraph (1), in any case in which 
        neither the State nor the political subdivision in 
        which such area is located has applied for a grant 
        under paragraph (1), the Secretary may make a grant 
        under such paragraph to any grantee under section 329, 
        330, or 340A for carrying out such activities in the 
        area.
            (3) Provision of all services and activities 
        through each grantee.--In making grants under paragraph 
        (1), the Secretary shall ensure that each of the 
        activities described in such paragraph is provided 
        through each grantee under such paragraph. The 
        Secretary may authorize such a grantee to provide the 
        services and activities directly, or through 
        arrangements with other providers.
    (b) Status as Medicaid Provider.--
            (1) In general.--Subject to paragraph (2), the 
        Secretary may not make a grant under subsection (a) 
        unless, in the case of any service described in such 
        subsection that is made available pursuant to the State 
        plan approved under title XIX of the Social Security 
        Act for the State involved--
                    (A) the applicant for the grant will 
                provide the service directly, and the applicant 
                has entered into a participation agreement 
                under the State plan and is qualified to 
                receive payments under such plan; or
                    (B) the applicant will enter into an 
                agreement with a provider under which the 
                provider will provide the service, and the 
                provider has entered into such a participation 
                agreement and is qualified to receive such 
                payments.
            (2) Waiver regarding certain secondary 
        agreements.--
                    (A) In the case of a provider making an 
                agreement pursuant to paragraph (1)(B) 
                regarding the provision of services, the 
                requirement established in such paragraph 
                regarding a participation agreement shall be 
                waived by the Secretary if the provider does 
                not, in providing health care services, impose 
                a charge or accept reimbursement available from 
                any third-party payor, including reimbursement 
                under any insurance policy or under any Federal 
                or State health benefits plan.
                    (B) A determination by the Secretary of 
                whether a provider referred to in subparagraph 
                (A) meets the criteria for a waiver under such 
                subparagraph shall be made without regard to 
                whether the provider accepts voluntary 
                donations regarding the provision of services 
                to the public.
    (c) Priority in Making Grants.--In making grants under 
subsection (a), the Secretary shall give priority to 
applications for programs that will serve areas with a high 
incidence of elevated blood lead levels in infants and 
children.
    (d) Grant Application.--No grant may be made under 
subsection (a), unless an application therefor has been 
submitted to, and approved by, the Secretary. Such an 
application shall be in such form and shall be submitted in 
such manner as the Secretary shall prescribe and shall include 
each of the following:
            (1) A complete description of the program which is 
        to be provided by or through the applicant.
            (2) Assurances satisfactory to the Secretary that 
        the program to be provided under the grant applied for 
        will include educational programs designed to--
                    (A) communicate to parents, educators, and 
                local health officials the significance and 
                prevalence of lead poisoning in infants and 
                children (including the sources of lead 
                exposure, the importance of screening young 
                children for lead, and the preventive steps 
                that parents can take in reducing the risk of 
                lead poisoning) which the program is designed 
                to detect and prevent; and
                    (B) communicate to health professionals and 
                paraprofessionals updated knowledge concerning 
                lead poisoning and research (including the 
                health consequences, if any, of low-level lead 
                burden; the prevalence of lead poisoning among 
                all socioeconomic groupings; the benefits of 
                expanded lead screening; and the therapeutic 
                and other interventions available to prevent 
                and combat lead poisoning in affected children 
                and families).
            (3) Assurances satisfactory to the Secretary that 
        the applicant will report on a quarterly basis the 
        number of infants and children screened for elevated 
        blood lead levels, the number of infants and children 
        who were found to have elevated blood lead levels, the 
        number and type of medical referrals made for such 
        infants and children, the outcome of such referrals, 
        and other information to measure program effectiveness.
            (4) Assurances satisfactory to the Secretary that 
        the applicant will make such reports respecting the 
        program involved as the Secretary may require.
            (5) Assurances satisfactory to the Secretary that 
        the applicant will coordinate the activities carried 
        out pursuant to subsection (a) with related activities 
        and services carried out in the State by grantees under 
        title V or XIX of the Social Security Act.
            (6) Assurances satisfactory to the Secretary that 
        Federal funds made available under such a grant for any 
        period will be so used as to supplement and, to the 
        extent practical, increase the level of State, local, 
        and other non-Federal funds that would, in the absence 
        of such Federal funds, be made available for the 
        program for which the grant is to be made and will in 
        no event supplant such State, local, and other non-
        Federal funds.
            (7) Assurances satisfactory to the Secretary that 
        the applicant will ensure complete and consistent 
        reporting of all blood lead test results from 
        laboratories and health care providers to State and 
        local health departments in accordance with guidelines 
        of the Centers for Disease Control and Prevention for 
        standardized reporting as described in subsection (m).
            (8) Such other information as the Secretary may 
        prescribe.
    (e) Relationship to Services and Activities Under Other 
Programs.--
            (1) In general.--A recipient of a grant under 
        subsection (a) may not make payments from the grant for 
        any service or activity to the extent that payment has 
        been made, or can reasonably be expected to be made, 
        with respect to such service or activity--
                    (A) under any State compensation program, 
                under an insurance policy, or under any Federal 
                or State health benefits program; or
                    (B) by an entity that provides health 
                services on a prepaid basis.
            (2) Applicability to certain secondary agreements 
        for provision of services.--Paragraph (1) shall not 
        apply in the case of a provider through which a grantee 
        under subsection (a) provides services under such 
        subsection if the Secretary has provided a waiver under 
        subsection (b)(2) regarding the provider.
    (f) Method and Amount of Payment.--The Secretary shall 
determine the amount of a grant made under subsection (a). 
Payments under such grants may be made in advance on the basis 
of estimates or by way of reimbursement, with necessary 
adjustments on account of underpayments or overpayments, and in 
such installments and on such terms and conditions as the 
Secretary finds necessary to carry out the purposes of such 
grants. Not more than 10 percent of any grant may be obligated 
for administrative costs.
    (g) Supplies, Equipment, and Employee Detail.--The 
Secretary, at the request of a recipient of a grant under 
subsection (a), may reduce the amount of such grant by--
            (1) the fair market value of any supplies or 
        equipment furnished the grant recipient; and
            (2) the amount of the pay, allowances, and travel 
        expenses of any officer or employee of the Government 
        when detailed to the grant recipient and the amount of 
        any other costs incurred in connection with the detail 
        of such officer or employee;
when the furnishing of such supplies or equipment or the detail 
of such an officer or employee is for the convenience of and at 
the request of such grant recipient and for the purpose of 
carrying out a program with respect to which the grant under 
subsection (a) is made. The amount by which any such grant is 
so reduced shall be available for payment by the Secretary of 
the costs incurred in furnishing the supplies or equipment, or 
in detailing the personnel, on which the reduction of such 
grant is based, and such amount shall be deemed as part of the 
grant and shall be deemed to have been paid to the grant 
recipient.
    (h) Records.--Each recipient of a grant under subsection 
(a) shall keep such records as the Secretary shall prescribe, 
including records which fully disclose the amount and 
disposition by such recipient of the proceeds of such grant, 
the total cost of the undertaking in connection with which such 
grant was made, and the amount of that portion of the cost of 
the undertaking supplied by other sources, and such other 
records as will facilitate an effective audit.
    (i) Audit and Examination of Records.--The Secretary and 
the Comptroller General of the United States, or any of their 
duly authorized representatives, shall have access for the 
purpose of audit and examination to any books, documents, 
papers, and records of the recipient of a grant under 
subsection (a), that are pertinent to such grant.
    (j) Annual Report.--
            (1) In general.--Not later than May 1 of each year, 
        the Secretary shall submit to the Congress a report on 
        the effectiveness during the preceding fiscal year of 
        programs carried out with grants under subsection (a) 
        and of any programs that are carried out by the 
        Secretary pursuant to subsection (l)(2).
            (2) Certain requirements.--Each report under 
        paragraph (1) shall include, in addition to any other 
        information that the Secretary may require, the 
        following information:
                    (A) The number of infants and children 
                screened.
                    (B) Demographic information on the 
                population of infants and children screened, 
                including the age and racial or ethnic status 
                of such population.
                    (C) The number of screening sites.
                    (D) A description of the severity of the 
                extent of the blood lead levels of the infants 
                and children screened, expressed in categories 
                of severity.
                    (E) The sources of payment for the 
                screenings.
                    (F) The number of grantees that have 
                established systems to ensure mandatory 
                reporting of all blood lead tests from 
                laboratories and health care providers to State 
                and local health departments.
                    (G) A comparison of the data provided 
                pursuant to subparagraphs (A) through (F) with 
                the equivalent data, if any, provided in the 
                report under paragraph (1) preceding the report 
                involved.
    (k) Indian Tribes.--For purposes of this section, the term 
``political subdivision'' includes Indian tribes.
    (l) Funding.--
            (1) Authorization of appropriations.--For the 
        purpose of carrying out this section, there are 
        authorized to be appropriated $40,000,000 for fiscal 
        year 1993, and such sums as may be necessary for each 
        of the fiscal years 1994 through 2005.
            (2) Allocation for other programs.--Of the amounts 
        appropriated under paragraph (1) for any fiscal year, 
        the Secretary may reserve not more than 20 percent for 
        carrying out programs regarding the activities 
        described in subsection (a) in addition to the program 
        of grants established in such subsection.
    (m) Guidelines for Standardized Reporting.--The Secretary, 
acting through the Director of the Centers for Disease Control 
and Prevention, shall develop national guidelines for the 
uniform reporting of all blood lead test results to State and 
local health departments.
   education, technology assessment, and epidemiology regarding lead 
                               poisoning
    Sec. 317B. [247b-3] (a) Prevention.--
            (1) Public education.--The Secretary, acting 
        through the Director of the Centers for Disease Control 
        and Prevention, shall carry out a program to educate 
        health professionals and paraprofessionals and the 
        general public on the prevention of lead poisoning in 
        infants and children. In carrying out the program, the 
        Secretary shall make available information concerning 
        the health effects of low-level lead toxicity, the 
        causes of lead poisoning, and the primary and secondary 
        preventive measures that may be taken to prevent such 
        poisoning.
            (2) Interagency task force.--
                    (A) Not later than 6 months after the date 
                of the enactment of the Preventive Health 
                Amendments of 1992 \1\, the Secretary shall 
                establish a council to be known as the 
                Interagency Task Force on the Prevention of 
                Lead Poisoning (in this paragraph referred to 
                as the ``Task Force''). The Task Force shall 
                coordinate the efforts of Federal agencies to 
                prevent lead poisoning.
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    \1\ Enacted October 27, 1992.
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                    (B) The Task Force shall be composed of--
                            (i) the Secretary, who shall serve 
                        as the chair of the Task Force;
                            (ii) the Secretary of Housing and 
                        Urban Development;
                            (iii) the Administrator of the 
                        Environmental Protection Agency; and
                            (iv) senior staff of each of the 
                        officials specified in clauses (i) 
                        through (iii), as selected by the 
                        officials respectively.
                    (C) The Task Force shall--
                            (i) review, evaluate, and 
                        coordinate current strategies and plans 
                        formulated by the officials serving as 
                        members of the Task Force, including--
                                    (I) the plan of the 
                                Secretary of Health and Human 
                                Services entitled ``Strategic 
                                Plan for the Elimination of 
                                Lead Poisoning'', dated 
                                February 21, 1991;
                                    (II) the plan of the 
                                Secretary of Housing and Urban 
                                Development entitled 
                                ``Comprehensive and Workable 
                                Plan for the Abatement of Lead-
                                Based Paint in Privately Owned 
                                Housing'', dated December 7, 
                                1990; and
                                    (III) the strategy of the 
                                Administrator of the 
                                Environmental Protection Agency 
                                entitled ``Strategy for 
                                Reducing Lead Exposures'', 
                                dated February 21, 1991;
                            (ii) develop a unified 
                        implementation plan for programs that 
                        receive Federal financial assistance 
                        for activities related to the 
                        prevention of lead poisoning;
                            (iii) establish a mechanism for 
                        sharing and disseminating information 
                        among the agencies represented on the 
                        Task Force;
                            (iv) identify the most promising 
                        areas of research and education 
                        concerning lead poisoning;
                            (v) identify the practical and 
                        technological constraints to expanding 
                        lead poisoning prevention;
                            (vi) annually carry out a 
                        comprehensive review of Federal 
                        programs providing assistance to 
                        prevent lead poisoning, and not later 
                        than May 1 of each year, submit to the 
                        Committee on Labor and Human Resources 
                        of the Senate and the Committee on the 
                        Environment and Public Works of the 
                        Senate, and to the Committee on Energy 
                        and Commerce of the House of 
                        Representatives, a report that 
                        summarizes the findings made as a 
                        result of such review and that contains 
                        the recommendations of the Task Force 
                        on the programs and policies with 
                        respect to which the Task Force is 
                        established, including related 
                        budgetary recommendations; and
                            (vii) annually review and 
                        coordinate departmental and agency 
                        budgetary requests with respect to all 
                        lead poisoning prevention activities of 
                        the Federal   Government.
    (b) Technology Assessment and Epidemiology.--The Secretary, 
acting through the Director of the Centers for Disease Control 
and Prevention, shall, directly or through grants or 
contracts--
            (1) provide for the development of improved, more 
        cost-effective testing measures for detecting lead 
        toxicity in children;
            (2) provide for the development of improved methods 
        of assessing the prevalence of lead poisoning, 
        including such methods as may be necessary to conduct 
        individual assessments for each State;
            (3) provide for the collection of data on the 
        incidence and prevalence of lead poisoning of infants 
        and children, on the demographic characteristics of 
        infants and children with such poisoning (including 
        racial and ethnic status), and on the source of payment 
        for treatment for such poisoning (including the extent 
        to which insurance has paid for such treatment); and
            (4) provide for any applied research necessary to 
        improve the effectiveness of programs for the 
        prevention of lead poisoning in infants and children.
    national center on birth defects and developmental disabilities
    Sec. 317C. [247b-4] (a) In General.--
            (1) National center.--There is established within 
        the Centers for Disease Control and Prevention a center 
        to be known as the National Center on Birth Defects and 
        Developmental Disabilities (referred to in this section 
        as the ``Center''), which shall be headed by a director 
        appointed by the Director of the Centers for Disease 
        Control and Prevention.
            (2) General duties.--The Secretary shall carry out 
        programs--
                    (A) to collect, analyze, and make available 
                data on birth defects, developmental 
                disabilities, and disabilities and health (in a 
                manner that facilitates compliance with 
                subsection (c)(2)), including data on the 
                causes of such defects and disabilities and on 
                the incidence and prevalence of such defects 
                and disabilities;
                    (B) to operate regional centers for the 
                conduct of applied epidemiological research on 
                the prevention of such defects and 
                disabilities;
                    (C) to provide information and education to 
                the public on the prevention of such defects 
                and disabilities;
                    (D) to conduct research on and to promote 
                the prevention of such defects and 
                disabilities, and secondary health conditions 
                among individuals with disabilities; and
                    (E) to support a National Spina Bifida 
                Program to prevent and reduce suffering from 
                the Nation's most common permanently disabling 
                birth defect.
            (3) Folic acid.--The Secretary shall carry out 
        section 317J through the Center.
            (4) Certain programs.--
                    (A) Transfers.--All programs and functions 
                described in subparagraph (B) are transferred 
                to the Center, effective upon the expiration of 
                the 180-day period beginning on the date of the 
                enactment of the Children's Health Act of 2000 
                \1\.
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    \1\ Public Law 106-310, enacted October 17, 2000.
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                    (B) Relevant programs.--The programs and 
                functions described in this subparagraph are 
                all programs and functions that--
                            (i) relate to birth defects; folic 
                        acid; cerebral palsy; mental 
                        retardation; child development; newborn 
                        screening; autism; fragile X syndrome; 
                        fetal alcohol syndrome; pediatric 
                        genetic disorders; disability 
                        prevention; or other relevant diseases, 
                        disorders, or conditions as determined 
                        the Secretary; and
                            (ii) were carried out through the 
                        National Center for Environmental 
                        Health as of the day before the date of 
                        the enactment of the Act referred to in 
                        subparagraph (A).
                    (C) Related transfers.--Personnel employed 
                in connection with the programs and functions 
                specified in subparagraph (B), and amounts 
                available for carrying out the programs and 
                functions, are transferred to the Center, 
                effective upon the expiration of the 180-day 
                period beginning on the date of the enactment 
                of the Act referred to in subparagraph (A). 
                Such transfer of amounts does not affect the 
                period of availability of the amounts, or the 
                availability of the amounts with respect to the 
                purposes for which the amounts may be expended.
    (b) Grants and Contracts.--
            (1) In general.--In carrying out subsection (a), 
        the Secretary may make grants to and enter into 
        contracts with public and nonprofit private entities.
            (2) Supplies and services in lieu of award funds.--
                    (A) Upon the request of a recipient of an 
                award of a grant or contract under paragraph 
                (1), the Secretary may, subject to subparagraph 
                (B), provide supplies, equipment, and services 
                for the purpose of aiding the recipient in 
                carrying out the purposes for which the award 
                is made and, for such purposes, may detail to 
                the recipient any officer or employee of the 
                Department of Health and Human Services.
                    (B) With respect to a request described in 
                subparagraph (A), the Secretary shall reduce 
                the amount of payments under the award involved 
                by an amount equal to the costs of detailing 
                personnel and the fair market value of any 
                supplies, equipment, or services provided by 
                the Secretary. The Secretary shall, for the 
                payment of expenses incurred in complying with 
                such request, expend the amounts withheld.
            (3) Application for award.--The Secretary may make 
        an award of a grant or contract under paragraph (1) 
        only if an application for the award is submitted to 
        the Secretary and the application is in such form, is 
        made in such manner, and contains such agreements, 
        assurances, and information as the Secretary determines 
        to be necessary to carry out the purposes for which the 
        award is to be made.
    (c) Biennial Report.--Not later than February 1 of fiscal 
year 1999 and of every second such year thereafter, the 
Secretary shall submit to the Committee on Commerce of the 
House of Representatives, and the Committee on Labor and Human 
Resources of the Senate, a report that, with respect to the 
preceding 2 fiscal years--
            (1) contains information regarding the incidence 
        and prevalence of birth defects, developmental 
        disabilities, and the health status of individuals with 
        disabilities and the extent to which these conditions 
        have contributed to the incidence and prevalence of 
        infant mortality and affected quality of life;
            (2) contains information under paragraph (1) that 
        is specific to various racial and ethnic groups 
        (including Hispanics, non-Hispanic whites, Blacks, 
        Native Americans, and Asian Americans);
            (3) contains an assessment of the extent to which 
        various approaches of preventing birth defects, 
        developmental disabilities, and secondary health 
        conditions among individuals with disabilities have 
        been effective;
            (4) describes the activities carried out under this 
        section;
            (5) contains information on the incidence and 
        prevalence of individuals living with birth defects and 
        disabilities or developmental disabilities, information 
        on the health status of individuals with disabilities, 
        information on any health disparities experienced by 
        such individuals, and recommendations for improving the 
        health and wellness and quality of life of such 
        individuals;
            (6) contains a summary of recommendations from all 
        birth defects research conferences sponsored by the 
        Centers for Disease Control and Prevention, including 
        conferences related to spina bifida; and
            (7) contains any recommendations of the Secretary 
        regarding this section.
    (d) Applicability of Privacy Laws.--The provisions of this 
section shall be subject to the requirements of section 552a of 
title 5, United States Code. All Federal laws relating to the 
privacy of information shall apply to the data and information 
that is collected under this section.
    (e) Advisory Committee.--Notwithstanding any other 
provision of law, the members of the advisory committee 
appointed by the Director of the National Center for 
Environmental Health that have expertise in birth defects, 
developmental disabilities, and disabilities and health shall 
be transferred to and shall advise the National Center on Birth 
Defects and Developmental Disabilities effective on the date of 
enactment of the Birth Defects and Developmental Disabilities 
Prevention Act of 2003.
    (f) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of fiscal 
years 2003 through 2007.
       preventive health measures with respect to prostate cancer
    Sec. 317D. [247b-5] (a) In General.--The Secretary, acting 
through the Director of the Centers for Disease Control and 
Prevention, may make grants to States and local health 
departments for the purpose of enabling such States and 
departments to carry out programs that may include the 
following:
            (1) To identify factors that influence the 
        attitudes or levels of awareness of men and health care 
        practitioners regarding screening for prostate cancer.
            (2) To evaluate, in consultation with the Agency 
        for Health Care Policy and Research and the National 
        Institutes of Health, the effectiveness of screening 
        strategies for prostate cancer.
            (3) To identify, in consultation with the Agency 
        for Health Care Policy and Research, issues related to 
        the quality of life for men after prostrate cancer 
        screening and followup.
            (4) To develop and disseminate public information 
        and education programs for prostate cancer, including 
        appropriate messages about the risks and benefits of 
        prostate cancer screening for the general public, 
        health care providers, policy makers and other 
        appropriate individuals.
            (5) To improve surveillance for prostate cancer.
            (6) To address the needs of underserved and 
        minority populations regarding prostate cancer.
            (7) Upon a determination by the Secretary, who 
        shall take into consideration recommendations by the 
        United States Preventive Services Task Force and shall 
        seek input, where appropriate, from professional 
        societies and other private and public entities, that 
        there is sufficient consensus on the effectiveness of 
        prostate cancer screening--
                    (A) to screen men for prostate cancer as a 
                preventive health measure;
                    (B) to provide appropriate referrals for 
                the medical treatment of men who have been 
                screened under subparagraph (A) and to ensure, 
                to the extent practicable, the provision of 
                appropriate followup services and support 
                services such as case management;
                    (C) to establish mechanisms through which 
                State and local health departments can monitor 
                the quality of screening procedures for 
                prostate cancer, including the interpretation 
                of such procedures; and
                    (D) to improve, in consultation with the 
                Health Resources and Services Administration, 
                the education, training, and skills of health 
                practitioners (including appropriate allied 
                health professionals) in the detection and 
                control of prostate cancer.
            (8) To evaluate activities conducted under 
        paragraphs (1) through (7) through appropriate 
        surveillance or program monitoring activities.
    (b) Requirement of Matching Funds.--
            (1) In general.--The Secretary may not make a grant 
        under subsection (a) unless the applicant involved 
        agrees, with respect to the costs to be incurred by the 
        applicant in carrying out the purpose described in such 
        section, to make available non-Federal contributions 
        (in cash or in kind under paragraph (2)) toward such 
        costs in an amount equal to not less than $1 for each 
        $3 of Federal funds provided in the grant. Such 
        contributions may be made directly or through donations 
        from public or private entities.
            (2) Determination of amount of non-federal 
        contribution.--
                    (A) Non-Federal contributions required in 
                paragraph (1) may be in cash or in kind, fairly 
                evaluated, including equipment or services (and 
                excluding indirect or overhead costs). Amounts 
                provided by the Federal Government, or services 
                assisted or subsidized to any significant 
                extent by the Federal Government, may not be 
                included in determining the amount of such non-
                Federal contributions.
                    (B) In making a determination of the amount 
                of non-Federal contributions for purposes of 
                paragraph (1), the Secretary may include only 
                non-Federal contributions in excess of the 
                average amount of non-Federal contributions 
                made by the applicant involved toward the 
                purpose described in subsection (a) for the 2-
                year period preceding the fiscal year for which 
                the applicant involved is applying to receive a 
                grant under such subsection.
                    (C) In making a determination of the amount 
                of non-Federal contributions for purposes of 
                paragraph (1), the Secretary shall, subject to 
                subparagraphs (A) and (B) of this paragraph, 
                include any non-Federal amounts expended 
                pursuant to title XIX of the Social Security 
                Act by the applicant involved toward the 
                purpose described in paragraphs (1) and (2) of 
                subsection (a).
    (c) Education on Significance of Early Detection.--The 
Secretary may not make a grant under subsection (a) unless the 
applicant involved agrees that, in carrying out subsection 
(a)(3), the applicant will carry out education programs to 
communicate to men, and to local health officials, the 
significance of the early detection of prostate cancer.
    (d) Requirement of Provision of All Services by Date 
Certain.--The Secretary may not make a grant under subsection 
(a) unless the applicant involved agrees--
            (1) to ensure that, initially and throughout the 
        period during which amounts are received pursuant to 
        the grant, not less than 60 percent of the grant is 
        expended to provide each of the services or activities 
        described in paragraphs (1) and (2) of such subsection;
            (2) to ensure that, by the end of any second fiscal 
        year of payments pursuant to the grant, each of the 
        services or activities described in such subsection is 
        provided; and
            (3) to ensure that not more than 40 percent of the 
        grant is expended to provide the services or activities 
        described in paragraphs (3) through (6) of such section 
        \1\.
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    \1\ So in law. Probably should be ``subsection''.
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    (e) Additional Required Agreements.--
            (1) Priority for low-income men.--The Secretary may 
        not make a grant under subsection (a) unless the 
        applicant involved agrees that low-income men, and men 
        at risk of prostate cancer, will be given priority in 
        the provision of services and activities pursuant to 
        paragraphs (1) and (2) of such subsection.
            (2) Limitation on imposition of fees for 
        services.--The Secretary may not make a grant under 
        subsection (a) unless the applicant involved agrees 
        that, if a charge is imposed for the provision of 
        services or activities under the grant, such charge--
                    (A) will be made according to a schedule of 
                charges that is made available to the public;
                    (B) will be adjusted to reflect the income 
                of the man involved; and
                    (C) will not be imposed on any man with an 
                income of less than 100 percent of the official 
                poverty line, as established by the Director of 
                the Office of Management and Budget and revised 
                by the Secretary in accordance with section 
                673(2) of the Omnibus Budget Reconciliation Act 
                of 1981.
            (3) Relationship to items and services under other 
        programs.--The Secretary may not make a grant under 
        subsection (a) unless the applicant involved agrees 
        that the grant will not be expended to make payment for 
        any item or service to the extent that payment has been 
        made, or can reasonably be expected to be made, with 
        respect to such item or service--
                    (A) under any State compensation program, 
                under an insurance policy, or under any Federal 
                or State health benefits program; or
                    (B) by an entity that provides health 
                services on a prepaid basis.
            (4) Coordination with other prostate cancer 
        programs.--The Secretary may not make a grant under 
        subsection (a) unless the applicant involved agrees 
        that the services and activities funded through the 
        grant will be coordinated with other Federal, State, 
        and local prostate cancer programs.
            (5) Limitation on administrative expenses.--The 
        Secretary may not make a grant under subsection (a) 
        unless the applicant involved agrees that not more than 
        10 percent of the grant will be expended for 
        administrative expenses with respect to the grant.
            (6) Restrictions on use of grant.--The Secretary 
        may not make a grant under subsection (a) unless the 
        applicant involved agrees that the grant will not be 
        expended to provide inpatient hospital services for any 
        individual.
            (7) Records and audits.--The Secretary may not make 
        a grant under subsection (a) unless the applicant 
        involved agrees that--
                    (A) the applicant will establish such 
                fiscal control and fund accounting procedures 
                as may be necessary to ensure the proper 
                disbursal of, and accounting for, amounts 
                received by the applicant under such section; 
                and
                    (B) upon request, the applicant will 
                provide records maintained pursuant to 
                paragraph (1) to the Secretary or the 
                Comptroller of the United States for purposes 
                of auditing the expenditures by the applicant 
                of the grant.
    (f) Reports to Secretary.--The Secretary may not make a 
grant under subsection (a) unless the applicant involved agrees 
to submit to the Secretary such reports as the Secretary may 
require with respect to the grant.
    (g) Description of Intended Uses of Grant.--The Secretary 
may not make a grant under subsection (a) unless--
            (1) the applicant involved submits to the Secretary 
        a description of the purposes for which the applicant 
        intends to expend the grant;
            (2) the description identifies the populations, 
        areas, and localities in the applicant \1\ with a need 
        for the services or activities described in subsection 
        (a);
---------------------------------------------------------------------------
    \1\ So in law.
---------------------------------------------------------------------------
            (3) the description provides information relating 
        to the services and activities to be provided, 
        including a description of the manner in which the 
        services and activities will be coordinated with any 
        similar services or activities of public or nonprivate 
        entities; and
            (4) the description provides assurances that the 
        grant funds will be used in the most cost-effective 
        manner.
    (h) Requirement of Submission of Application.--The 
Secretary may not make a grant under subsection (a) unless an 
application for the grant is submitted to the Secretary, the 
application contains the description of intended uses required 
in subsection (g), and the application is in such form, is made 
in such manner, and contains such agreements, assurances, and 
information as the Secretary determines to be necessary to 
carry out this section.
    (i) Method and Amount of Payment.--The Secretary shall 
determine the amount of a grant made under subsection (a). 
Payments under such grants may be made in advance on the basis 
of estimates or by way of reimbursement, with necessary 
adjustments on account of the underpayments or overpayments, 
and in such installments and on such terms and conditions as 
the Secretary finds necessary to carry out the purposes of such 
grants.
    (j) Technical Assistance and Provision of Supplies and 
Services in Lieu of Grant Funds.--
            (1) Technical assistance.--The Secretary may 
        provide training and technical assistance with respect 
        to the planning, development, and operation of any 
        program or service carried out pursuant to subsection 
        (a). The Secretary may provide such technical 
        assistance directly or through grants to, or contracts 
        with, public and private entities.
            (2) Provision of supplies and services in lieu of 
        grant funds.--
                    (A) Upon the request of an applicant 
                receiving a grant under subsection (a), the 
                Secretary may, subject to subparagraph (B), 
                provide supplies, equipment, and services for 
                the purpose of aiding the applicant in carrying 
                out such section and, for such purpose, may 
                detail to the applicant any officer or employee 
                of the Department of Health and Human Services.
                    (B) With respect to a request described in 
                subparagraph (A), the Secretary shall reduce 
                the amount of payments under the grant under 
                subsection (a) to the applicant involved by an 
                amount equal to the costs of detailing 
                personnel (including pay, allowances, and 
                travel expenses) and the fair market value of 
                any supplies, equipment, or services provided 
                by the Secretary. The Secretary shall, for the 
                payment of expenses incurred in complying with 
                such request, expend the amounts withheld.
    (k) Definition.--For purposes of this section, the term 
``units of local government'' includes Indian tribes.
    (l) Authorization of Appropriations.--
            (1) In general.--For the purpose of carrying out 
        this section, there are authorized to be appropriated 
        $20,000,000 for fiscal year 1993, and such sums as may 
        be necessary for each of the fiscal years 1994 through 
        2004.
            (2) Allocation for technical assistance.--Of the 
        amounts appropriated under paragraph (1) for a fiscal 
        year, the Secretary shall reserve not more than 20 
        percent for carrying out subsection (j)(1).
      national strategy for combating and eliminating tuberculosis
    Sec. 317E. [247b-6] (a) In General.--The Secretary, acting 
through the Director of the Centers for Disease Control and 
Prevention, may make grants to States, political subdivisions, 
and other public entities for preventive health service 
programs for the prevention, control, and elimination of 
tuberculosis.
    (b) Research and Development; Demonstration Projects; 
Education and Training.--With respect to the prevention, 
treatment, control, and elimination of tuberculosis, the 
Secretary may, directly or through grants to public or 
nonprofit private entities, carry out the following:
            (1) Research, with priority given to research and 
        development concerning latent tuberculosis infection, 
        strains of tuberculosis resistant to drugs, and 
        research concerning cases of tuberculosis that affect 
        certain populations at risk for tuberculosis.
            (2) Research and development and related activities 
        to develop new tools for the elimination of 
        tuberculosis, including drugs, diagnostics, vaccines, 
        and public health interventions, such as directly 
        observed therapy and non-pharmaceutical intervention, 
        and methods to enhance detection and response to 
        outbreaks of tuberculosis, including multidrug 
        resistant tuberculosis. The Secretary is encouraged to 
        give priority to programmatically relevant research so 
        that new tools can be utilized in public health 
        practice.
            (3) Demonstration projects for--
                    (A) the development of regional 
                capabilities to prevent, control, and eliminate 
                tuberculosis and prevent multidrug resistant 
                and extensively drug resistant strains of 
                tuberculosis;
                    (B) the intensification of efforts to 
                reduce health disparities in the incidence of 
                tuberculosis;
                    (C) the intensification of efforts to 
                control tuberculosis along the United States-
                Mexico border and among United States-Mexico 
                binational populations, including through 
                expansion of the scope and number of programs 
                that--
                            (i) detect and treat binational 
                        cases of tuberculosis; and
                            (ii) treat high-risk cases of 
                        tuberculosis referred from Mexican 
                        health departments;
                    (D) the intensification of efforts to 
                prevent, detect, and treat tuberculosis among 
                foreign-born persons who are in the United 
                States;
                    (E) the intensification of efforts to 
                prevent, detect, and treat tuberculosis among 
                populations and settings documented as having a 
                high risk for tuberculosis; and
                    (F) tuberculosis detection, control, and 
                prevention.
            (4) Public information and education activities.
            (5) Education, training, clinical skills 
        improvement activities, and workplace exposure 
        prevention for health professionals, including allied 
        health personnel and emergency response employees.
            (6) Support of Centers to carry out activities 
        under paragraphs (1) through (4).
            (7) Collaboration with international organizations 
        and foreign countries in carrying out such activities.
            (8) Develop, enhance, and expand information 
        technologies that support tuberculosis control 
        including surveillance and database management systems 
        with cross-jurisdictional capabilities, which shall 
        conform to the standards and implementation 
        specifications for such information technologies as 
        recommended by the Secretary.
    (c) Cooperation With Providers of Primary Health 
Services.--The Secretary may make a grant under subsection (a) 
or (b) only if the applicant for the grant agrees that, in 
carrying out activities under the grant, the applicant will 
cooperate with public and nonprofit private providers of 
primary health services or substance abuse services, including 
entities receiving assistance under section 329, 330, or 340A 
or under title V or XIX.
    (d) Application for Grant.--
            (1) In general.--The Secretary may make a grant 
        under subsection (a) or (b) only if an application for 
        the grant is submitted to the Secretary and the 
        application, subject to paragraph (2), is in such form, 
        is made in such manner, and contains such agreements, 
        assurances, and information as the Secretary determines 
        to be necessary to carry out the subsection involved.
            (2) Plan for prevention, control, and 
        elimination.--The Secretary may make a grant under 
        subsection (a) only if the application under paragraph 
        (1) contains a plan regarding the prevention, control, 
        and elimination of tuberculosis in the geographic area 
        with respect to which the grant is sought.
            (3) Determination of amount of nonfederal 
        contributions.--
                    (A) Priority.--In awarding grants under 
                subsection (a) or (b), the Secretary shall give 
                highest priority to an applicant that provides 
                assurances that the applicant will contribute 
                non-Federal funds to carry out activities under 
                this section, which may be provided directly or 
                through donations from public or private 
                entities and may be in cash or in kind, 
                including equipment or services.
                    (B) Federal amounts not to be included as 
                contributions.--Amounts provided by the Federal 
                Government, or services assisted or subsidized 
                to any significant extent by the Federal 
                Government, may not be included in determining 
                the amount of non-Federal contributions as 
                described in subparagraph (A).
    (e) Supplies and Services in Lieu of Grant Funds.--
            (1) In general.--Upon the request of a grantee 
        under subsection (a) or (b), the Secretary may, subject 
        to paragraph (2), provide supplies, equipment, and 
        services for the purpose of aiding the grantee in 
        carrying out the subsection involved and, for such 
        purpose, may detail to the State any officer or 
        employee of the Department of Health and Human 
        Services.
            (2) Corresponding reduction in payments.--With 
        respect to a request described in paragraph (1), the 
        Secretary shall reduce the amount of payments under the 
        grant involved by an amount equal to the costs of 
        detailing personnel and the fair market value of any 
        supplies, equipment, or services provided by the 
        Secretary. The Secretary shall, for the payment of 
        expenses incurred in complying with such request, 
        expend the amounts withheld.
    (f) Advisory Council.--
            (1) In general.--The Secretary shall establish an 
        advisory council to be known as the Advisory Council 
        for the Elimination of Tuberculosis (in this subsection 
        referred to as the ``Council'').
            (2) Duties.--The Council shall provide advice and 
        recommendations regarding the elimination of 
        tuberculosis to the Secretary. In addition, the Council 
        shall, with respect to eliminating such disease, 
        provide to the Secretary and other appropriate Federal 
        officials advice on--
                    (A) coordinating the activities of the 
                Department of Health and Human Services and 
                other Federal agencies that relate to the 
                disease, including activities under subsection 
                (b);
                    (B) responding rapidly and effectively to 
                emerging issues in tuberculosis; and
                    (C) efficiently utilizing the Federal 
                resources involved.
            (3) Comprehensive plan.--
                    (A) In general.--In carrying out paragraph 
                (2), the Council shall make or update 
                recommendations on the development, revision, 
                and implementation of a comprehensive plan to 
                eliminate tuberculosis in the United States.
                    (B) Consultation.--In carrying out 
                subparagraph (A), the Council may consult with 
                appropriate public and private entities, which 
                may, subject to the direction or discretion of 
                the Secretary, include--
                            (i) individuals who are scientists, 
                        physicians, laboratorians, and other 
                        health professionals, who are not 
                        officers or employees of the Federal 
                        Government and who represent the 
                        disciplines relevant to tuberculosis 
                        elimination;
                            (ii) members of public-private 
                        partnerships or private entities 
                        established to address the elimination 
                        of tuberculosis;
                            (iii) members of national and 
                        international nongovernmental 
                        organizations whose purpose is to 
                        eliminate tuberculosis;
                            (iv) members from the general 
                        public who are knowledgeable with 
                        respect to tuberculosis elimination 
                        including individuals who have or have 
                        had tuberculosis; and
                            (v) scientists, physicians, 
                        laboratorians, and other health 
                        professionals who reside in a foreign 
                        country with a substantial incidence or 
                        prevalence of tuberculosis, and who 
                        represent the specialties and 
                        disciplines relevant to the research 
                        under consideration.
                    (C) Certain components of plan.--In 
                carrying out subparagraph (A), the Council 
                shall, subject to the direction or discretion 
                of the Secretary--
                            (i) consider recommendations for 
                        the involvement of the United States in 
                        continuing global and cross-border 
                        tuberculosis control activities in 
                        countries where a high incidence of 
                        tuberculosis directly affects the 
                        United States; and
                            (ii) review the extent to which 
                        progress has been made toward 
                        eliminating tuberculosis.
            (4) Biennial report.--
                    (A) In general.--The Council shall submit a 
                biennial report to the Secretary, as determined 
                necessary by the Secretary, on the activities 
                carried under this section. Each such report 
                shall include the opinion of the Council on the 
                extent to which its recommendations regarding 
                the elimination of tuberculosis have been 
                implemented, including with respect to--
                            (i) activities under subsection 
                        (b); and
                            (ii) the national plan referred to 
                        in paragraph (3).
                    (B) Public.--The Secretary shall make a 
                report submitted under subparagraph (A) public.
            (5) Composition.--The Council shall be composed 
        of--
                    (A) ex officio representatives from the 
                Centers for Disease Control and Prevention, the 
                National Institutes of Health, the United 
                States Agency for International Development, 
                the Agency for Healthcare Research and Quality, 
                the Health Resources and Services 
                Administration, the United States-Mexico Border 
                Health Commission, and other Federal 
                departments and agencies that carry out 
                significant activities related to tuberculosis;
                    (B) State and local tuberculosis control 
                and public health officials;
                    (C) individuals who are scientists, 
                physicians, laboratorians, and other health 
                professionals who represent disciplines 
                relevant to tuberculosis elimination; and
                    (D) members of national and international 
                nongovernmental organizations established to 
                address the elimination of tuberculosis.
            (6) Staff, information, and other assistance.--The 
        Secretary shall provide to the Council such staff, 
        information, and other assistance as may be necessary 
        to carry out the duties of the Council.
    (g) Federal Tuberculosis Task Force.--
            (1) Duties.--The Federal Tuberculosis Task Force 
        (in this subsection referred to as the ``Task Force'') 
        shall provide to the Secretary and other appropriate 
        Federal officials advice on research into new tools 
        under subsection (b)(2), including advice regarding the 
        efficient utilization of the Federal resources 
        involved.
            (2) Comprehensive plan for new tools development.--
        In carrying out paragraph (1), the Task Force shall 
        make recommendations on the development of a 
        comprehensive plan for the creation of new tools for 
        the elimination of tuberculosis, including drugs, 
        diagnostics, and vaccines.
            (3) Consultation.--In developing the comprehensive 
        plan under paragraph (1), the Task Force shall consult 
        with external parties including representatives from 
        groups such as--
                    (A) scientists, physicians, laboratorians, 
                and other health professionals who represent 
                the specialties and disciplines relevant to the 
                research under consideration;
                    (B) members from public-private 
                partnerships, private entities, or foundations 
                (or both) engaged in activities relevant to 
                research under consideration;
                    (C) members of national and international 
                nongovernmental organizations established to 
                address tuberculosis elimination;
                    (D) members from the general public who are 
                knowledgeable with respect to tuberculosis 
                including individuals who have or have had 
                tuberculosis; and
                    (E) scientists, physicians, laboratorians, 
                and other health professionals who reside in a 
                foreign country with a substantial incidence or 
                prevalence of tuberculosis, and who represent 
                the specialties and disciplines relevant to the 
                research under consideration.
    (h) Authorization of Appropriations.--
            (1) General program.--
                    (A) In general.--For the purpose of 
                carrying out this section, there are authorized 
                to be appropriated $200,000,000 for fiscal year 
                2009, $210,000,000 for fiscal year 2010, 
                $220,500,000 for fiscal year 2011, $231,525,000 
                for fiscal year 2012, and $243,101,250 for 
                fiscal year 2013.
                    (B) Reservation for emergency grants.--Of 
                the amounts appropriated under subparagraph (A) 
                for a fiscal year, the Secretary may reserve 
                not more than 25 percent for emergency grants 
                under subsection (a) for any geographic area, 
                State, political subdivision of a State, or 
                other public entity in which there is, relative 
                to other areas, a substantial number of cases 
                of tuberculosis, multidrug resistant 
                tuberculosis, or extensively drug resistant 
                tuberculosis or a substantial rate of increase 
                in such cases.
                    (C) Priority.--In allocating amounts 
                appropriated under subparagraph (A), the 
                Secretary shall give priority to allocating 
                such amounts for grants under subsection (a).
                    (D) Allocation of funds.--
                            (i) Requirement of formula.--Of the 
                        amounts appropriated under subparagraph 
                        (A), not reserved under subparagraph 
                        (B), and allocated by the Secretary for 
                        grants under subsection (a), the 
                        Secretary shall distribute a portion of 
                        such amounts to grantees under 
                        subsection (a) on the basis of a 
                        formula.
                            (ii) Relevant factors.--The formula 
                        developed by the Secretary under clause 
                        (i) shall take into account the level 
                        of tuberculosis morbidity and case 
                        complexity in the respective geographic 
                        area and may consider other factors 
                        relevant to tuberculosis in such area.
                            (iii) No change to formula 
                        required.--This subparagraph does not 
                        require the Secretary to modify the 
                        formula that was used by the Secretary 
                        to distribute funds to grantees under 
                        subsection (a) for fiscal year 2009.
            (2) Limitation.--The authorization of 
        appropriations established in paragraph (1) for a 
        fiscal year is effective only if the amount 
        appropriated under such paragraph for such year equals 
        or exceeds the amount appropriated to carry out this 
        section for fiscal year 2009.
                         loan repayment program
    Sec. 317F. [247b-7] (a) In General.--
            (1) Authority.--Subject to paragraph (2), the 
        Secretary may carry out a program of entering into 
        contracts with appropriately qualified health 
        professionals under which such health professionals 
        agree to conduct prevention activities, as employees of 
        the Centers for Disease Control and Prevention and the 
        Agency for Toxic Substances and Disease Registry, in 
        consideration of the Federal Government agreeing to 
        repay, for each year of such service, not more than 
        $35,000 of the principal and interest of the 
        educational loans of such health professionals.
            (2) Limitation.--The Secretary may not enter into 
        an agreement with a health professional pursuant to 
        paragraph (1) unless such professional--
                    (A) has a substantial amount of educational 
                loans relative to income; and
                    (B) agrees to serve as an employee of the 
                Centers for Disease Control and Prevention or 
                the Agency for Toxic Substances and Disease 
                Registry for purposes of paragraph (1) for a 
                period of not less than 3 years.
    (b) Applicability of Certain Provisions.--With respect to 
the National Health Service Corps Loan Repayment Program 
established in subpart III of part D of title III of this Act, 
the provisions of such subpart shall, except as inconsistent 
with subsection (a), apply to the program established in this 
section in the same manner and to the same extent as such 
provisions apply to the National Health Service Corps Loan 
Repayment Program.
    (c) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated $500,000 for fiscal year 1994, and such sums as 
may be necessary for each of the fiscal years 1995 through 
2002.
    (d) Availability of Appropriations.--Amounts appropriated 
for a fiscal year for contracts under subsection (a) shall 
remain available until the expiration of the second fiscal year 
beginning after the fiscal year for which the amounts were 
appropriated.

SEC. 317G. [247B-8] FELLOWSHIP AND TRAINING PROGRAMS.

    The Secretary, acting through the Director of the Centers 
for Disease Control and Prevention, shall establish fellowship 
and training programs to be conducted by such Centers to train 
individuals to develop skills in epidemiology, surveillance, 
laboratory analysis, and other disease detection and prevention 
methods. Such programs shall be designed to enable health 
professionals and health personnel trained under such programs 
to work, after receiving such training, in local, State, 
national, and international efforts toward the prevention and 
control of diseases, injuries, and disabilities. Such 
fellowships and training may be administered through the use of 
either appointment or nonappointment procedures.
                     diabetes in children and youth
    Sec. 317H. [247b-9] (a) Surveillance on Juvenile 
Diabetes.--The Secretary, acting through the Director of the 
Centers for Disease Control and Prevention, shall develop a 
sentinel system to collect data on juvenile diabetes, including 
with respect to incidence and prevalence, and shall establish a 
national database for such data.
    (b) Type 2 Diabetes in Youth.--The Secretary shall 
implement a national public health effort to address type 2 
diabetes in youth, including--
            (1) enhancing surveillance systems and expanding 
        research to better assess the prevalence and incidence 
        of type 2 diabetes in youth and determine the extent to 
        which type 2 diabetes is incorrectly diagnosed as type 
        1 diabetes among children; and
            (2) developing and improving laboratory methods to 
        assist in diagnosis, treatment, and prevention of 
        diabetes including, but not limited to, developing 
        noninvasive ways to monitor blood glucose to prevent 
        hypoglycemia and improving existing glucometers that 
        measure blood glucose.
    (c) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2001 through 2005.
                     compilation of data on asthma
    Sec. 317I. [247b-10] (a) In General.--The Secretary, acting 
through the Director of the Centers for Disease Control and 
Prevention, shall--
            (1) conduct local asthma surveillance activities to 
        collect data on the prevalence and severity of asthma 
        and the quality of asthma management;
            (2) compile and annually publish data on the 
        prevalence of children suffering from asthma in each 
        State; and
            (3) to the extent practicable, compile and publish 
        data on the childhood mortality rate associated with 
        asthma nationally.
    (b) Surveillance Activities.--The Director of the Centers 
for Disease Control and Prevention, acting through the 
representative of the Director on the National Asthma Education 
Prevention Program Coordinating Committee, shall, in carrying 
out subsection (a), provide an update on surveillance 
activities at each Committee meeting.
    (c) Collaborative Efforts.--The activities described in 
subsection (a)(1) may be conducted in collaboration with 
eligible entities awarded a grant under section 399L.
    (d) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2001 through 2005.
          effects of folic acid in prevention of birth defects
    Sec. 317J. [247b-11] (a) In General.--The Secretary, acting 
through the Director of the Centers for Disease Control and 
Prevention, shall expand and intensify programs (directly or 
through grants or contracts) for the following purposes:
            (1) To provide education and training for health 
        professionals and the general public for purposes of 
        explaining the effects of folic acid in preventing 
        birth defects and for purposes of encouraging each 
        woman of reproductive capacity (whether or not planning 
        a pregnancy) to consume on a daily basis a dietary 
        supplement that provides an appropriate level of folic 
        acid.
            (2) To conduct research with respect to such 
        education and training, including identifying effective 
        strategies for increasing the rate of consumption of 
        folic acid by women of reproductive capacity.
            (3) To conduct research to increase the 
        understanding of the effects of folic acid in 
        preventing birth defects, including understanding with 
        respect to cleft lip, cleft palate, and heart defects.
            (4) To provide for appropriate epidemiological 
        activities regarding folic acid and birth defects, 
        including epidemiological activities regarding neural 
        tube defects.
    (b) Consultations With States and Private Entities.--In 
carrying out subsection (a), the Secretary shall consult with 
the States and with other appropriate public or private 
entities, including national nonprofit private organizations, 
health professionals, and providers of health insurance and 
health plans.
    (c) Technical Assistance.--The Secretary may (directly or 
through grants or contracts) provide technical assistance to 
public and nonprofit private entities in carrying out the 
activities described in subsection (a).
    (d) Evaluations.--The Secretary shall (directly or through 
grants or contracts) provide for the evaluation of activities 
under subsection (a) in order to determine the extent to which 
such activities have been effective in carrying out the 
purposes of the program under such subsection, including the 
effects on various demographic populations. Methods of 
evaluation under the preceding sentence may include surveys of 
knowledge and attitudes on the consumption of folic acid and on 
blood folate levels. Such methods may include complete and 
timely monitoring of infants who are born with neural tube 
defects.
    (e) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2001 through 2005.
                            safe motherhood
    Sec. 317K. [247b-12] (a) Surveillance.--
            (1) Purpose.--The purpose of this subsection is to 
        develop surveillance systems at the local, State, and 
        national level to better understand the burden of 
        maternal complications and mortality and to decrease 
        the disparities among population at risk of death and 
        complications from pregnancy.
            (2) Activities.--For the purpose described in 
        paragraph (1), the Secretary, acting through the 
        Director of the Centers for Disease Control and 
        Prevention, may carry out the following activities:
                    (A) The Secretary may establish and 
                implement a national surveillance program to 
                identify and promote the investigation of 
                deaths and severe complications that occur 
                during pregnancy.
                    (B) The Secretary may expand the Pregnancy 
                Risk Assessment Monitoring System to provide 
                surveillance and collect data in each State.
                    (C) The Secretary may expand the Maternal 
                and Child Health Epidemiology Program to 
                provide technical support, financial 
                assistance, or the time-limited assignment of 
                senior epidemiologists to maternal and child 
                health programs in each State.
    (b) Prevention Research.--
            (1) Purpose.--The purpose of this subsection is to 
        provide the Secretary with the authority to further 
        expand research concerning risk factors, prevention 
        strategies, and the roles of the family, health care 
        providers and the community in safe motherhood.
            (2) Research.--The Secretary may carry out 
        activities to expand research relating to--
                    (A) encouraging preconception counseling, 
                especially for at risk populations such as 
                diabetics;
                    (B) the identification of critical 
                components of prenatal delivery and postpartum 
                care;
                    (C) the identification of outreach and 
                support services, such as folic acid education, 
                that are available for pregnant women;
                    (D) the identification of women who are at 
                high risk for complications;
                    (E) preventing preterm delivery;
                    (F) preventing urinary tract infections;
                    (G) preventing unnecessary caesarean 
                sections;
                    (H) an examination of the higher rates of 
                maternal mortality among African American 
                women;
                    (I) an examination of the relationship 
                between domestic violence and maternal 
                complications and mortality;
                    (J) preventing and reducing adverse health 
                consequences that may result from smoking, 
                alcohol and illegal drug use before, during and 
                after pregnancy;
                    (K) preventing infections that cause 
                maternal and infant complications; and
                    (L) other areas determined appropriate by 
                the Secretary.
    (c) Prevention Programs.--
            (1) \1\ In general.--The Secretary may carry out 
        activities to promote safe motherhood, including--
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    \1\So in law. Subsection (c) does not contain a paragraph (2). See 
section 901 of Public Law 106-310 (114 Stat. 1126).
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                    (A) public education campaigns on healthy 
                pregnancies and the building of partnerships 
                with outside organizations concerned about safe 
                motherhood;
                    (B) education programs for physicians, 
                nurses and other health care providers; and
                    (C) activities to promote community support 
                services for pregnant women.
    (d) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2001 through 2005.
                     prenatal and postnatal health
    Sec. 317L. [247b-13] (a) In General.--The Secretary, acting 
through the Director of the Centers for Disease Control and 
Prevention, shall carry out programs--
            (1) to collect, analyze, and make available data on 
        prenatal smoking, alcohol and illegal drug use, 
        including data on the implications of such activities 
        and on the incidence and prevalence of such activities 
        and their implications;
            (2) to conduct applied epidemiological research on 
        the prevention of prenatal and postnatal smoking, 
        alcohol and illegal drug use;
            (3) to support, conduct, and evaluate the 
        effectiveness of educational and cessation programs; 
        and
            (4) to provide information and education to the 
        public on the prevention and implications of prenatal 
        and postnatal smoking, alcohol and illegal drug use.
    (b) Grants.--In carrying out subsection (a), the Secretary 
may award grants to and enter into contracts with States, local 
governments, scientific and academic institutions, federally 
qualified health centers, and other public and nonprofit 
entities, and may provide technical and consultative assistance 
to such entities.
    (c) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2001 through 2005.
              oral health promotion and disease prevention
    Sec. 317M. [247b-14] (a) Grants to Increase Resources for 
Community Water Fluoridation.--
            (1) In general.--The Secretary, acting through the 
        Director of the Centers for Disease Control and 
        Prevention, may make grants to States and Indian tribes 
        for the purpose of increasing the resources available 
        for community water fluoridation.
            (2) Use of funds.--A State shall use amounts 
        provided under a grant under paragraph (1)--
                    (A) to purchase fluoridation equipment;
                    (B) to train fluoridation engineers;
                    (C) to develop educational materials on the 
                benefits of fluoridation; or
                    (D) to support the infrastructure necessary 
                to monitor and maintain the quality of water 
                fluoridation.
    (b) Community Water Fluoridation.--
            (1) In general.--The Secretary, acting through the 
        Director of the Centers for Disease Control and 
        Prevention and in collaboration with the Director of 
        the Indian Health Service, shall establish a 
        demonstration project that is designed to assist rural 
        water systems in successfully implementing the water 
        fluoridation guidelines of the Centers for Disease 
        Control and Prevention that are entitled ``Engineering 
        and Administrative Recommendations for Water 
        Fluoridation, 1995'' (referred to in this subsection as 
        the ``EARWF'').
            (2) Requirements.--
                    (A) Collaboration.--In collaborating under 
                paragraph (1), the Directors referred to in 
                such paragraph shall ensure that technical 
                assistance and training are provided to tribal 
                programs located in each of the 12 areas of the 
                Indian Health Service. The Director of the 
                Indian Health Service shall provide 
                coordination and administrative support to 
                tribes under this section.
                    (B) General use of funds.--Amounts made 
                available under paragraph (1) shall be used to 
                assist small water systems in improving the 
                effectiveness of water fluoridation and to meet 
                the recommendations of the EARWF.
                    (C) Fluoridation specialists.--
                            (i) In general.--In carrying out 
                        this subsection, the Secretary shall 
                        provide for the establishment of 
                        fluoridation specialist engineering 
                        positions in each of the Dental 
                        Clinical and Preventive Support Centers 
                        through which technical assistance and 
                        training will be provided to tribal 
                        water operators, tribal utility 
                        operators and other Indian Health 
                        Service personnel working directly with 
                        fluoridation projects.
                            (ii) Liaison.--A fluoridation 
                        specialist shall serve as the principal 
                        technical liaison between the Indian 
                        Health Service and the Centers for 
                        Disease Control and Prevention with 
                        respect to engineering and fluoridation 
                        issues.
                            (iii) CDC.--The Director of the 
                        Centers for Disease Control and 
                        Prevention shall appoint individuals to 
                        serve as the fluoridation specialists.
                    (D) Implementation.--The project 
                established under this subsection shall be 
                planned, implemented and evaluated over the 5-
                year period beginning on the date on which 
                funds are appropriated under this section and 
                shall be designed to serve as a model for 
                improving the effectiveness of water 
                fluoridation systems of small rural 
                communities.
            (3) Evaluation.--In conducting the ongoing 
        evaluation as provided for in paragraph (2)(D), the 
        Secretary shall ensure that such evaluation includes--
                    (A) the measurement of changes in water 
                fluoridation compliance levels resulting from 
                assistance provided under this section;
                    (B) the identification of the 
                administrative, technical and operational 
                challenges that are unique to the fluoridation 
                of small water systems;
                    (C) the development of a practical model 
                that may be easily utilized by other tribal, 
                State, county or local governments in improving 
                the quality of water fluoridation with emphasis 
                on small water systems; and
                    (D) the measurement of any increased 
                percentage of Native Americans or Alaskan 
                Natives who receive the benefits of optimally 
                fluoridated water.
    (c) School-Based Dental Sealant Program.--
            (1) In general.--The Secretary, acting through the 
        Director of the Centers for Disease Control and 
        Prevention and in collaboration with the Administrator 
        of the Health Resources and Services Administration, 
        shall award a grant to each of the 50 States and 
        territories and to Indians, Indian tribes, tribal 
        organizations and urban Indian organizations (as such 
        terms are defined in section 4 of the Indian Health 
        Care Improvement Act) to provide for the development of 
        school-based dental sealant programs to improve the 
        access of children to sealants.
            (2) Use of funds.--A State shall use amounts 
        received under a grant under paragraph (1) to provide 
        funds to eligible school-based entities or to public 
        elementary or secondary schools to enable such entities 
        or schools to provide children with access to dental 
        care and dental sealant services. Such services shall 
        be provided by licensed dental health professionals in 
        accordance with State practice licensing laws.
            (3) Eligibility.--To be eligible to receive funds 
        under paragraph (1), an entity shall--
                    (A) prepare and submit to the State an 
                application at such time, in such manner and 
                containing such information as the State may 
                require; and
                    (B) be a public elementary or secondary 
                school--
                            (i) that is located in an urban 
                        area in which and more than 50 percent 
                        of the student population is 
                        participating in Federal or State free 
                        or reduced meal programs; or
                            (ii) that is located in a rural 
                        area and, with respect to the school 
                        district in which the school is 
                        located, the district involved has a 
                        median income that is at or below 235 
                        percent of the poverty line, as defined 
                        in section 673(2) of the Community 
                        Services Block Grant Act (42 U.S.C. 
                        9902(2)).
    (d) Oral Health Infrastructure.--
            (1) Cooperative agreements.--The Secretary, acting 
        through the Director of the Centers for Disease Control 
        and Prevention, shall enter into cooperative agreements 
        with State, territorial, and Indian tribes or tribal 
        organizations (as those terms are defined in section 4 
        of the Indian Health Care Improvement Act) to establish 
        oral health leadership and program guidance, oral 
        health data collection and interpretation, (including 
        determinants of poor oral health among vulnerable 
        populations), a multi-dimensional delivery system for 
        oral health, and to implement science-based programs 
        (including dental sealants and community water 
        fluoridation) to improve oral health.
            (2) Authorization of appropriations.--There is 
        authorized to be appropriated such sums as necessary to 
        carry out this subsection for fiscal years 2010 through 
        2014.
    (e) Definitions.--For purposes of this section, the term 
``Indian tribe'' means an Indian tribe or tribal organization 
as defined in section 4(b) and section 4(c) of the Indian Self-
Determination and Education Assistance Act.
    (f) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2001 through 2005.
         surveillance and education regarding hepatitis c virus
    Sec. 317N. [247b-15] (a) In General.--The Secretary, acting 
through the Director of the Centers for Disease Control and 
Prevention, may (directly and through grants to public and 
nonprofit private entities) provide for programs to carry out 
the following:
            (1) To cooperate with the States in implementing a 
        national system to determine the incidence of hepatitis 
        C virus infection (in this section referred to as ``HCV 
        infection'') and to assist the States in determining 
        the prevalence of such infection, including the 
        reporting of chronic HCV cases.
            (2) To identify, counsel, and offer testing to 
        individuals who are at risk of HCV infection as a 
        result of receiving blood transfusions prior to July 
        1992, or as a result of other risk factors.
            (3) To provide appropriate referrals for 
        counseling, testing, and medical treatment of 
        individuals identified under paragraph (2) and to 
        ensure, to the extent practicable, the provision of 
        appropriate follow-up services.
            (4) To develop and disseminate public information 
        and education programs for the detection and control of 
        HCV infection, with priority given to high risk 
        populations as determined by the Secretary.
            (5) To improve the education, training, and skills 
        of health professionals in the detection and control of 
        HCV infection, with priority given to pediatricians and 
        other primary care physicians, and obstetricians and 
        gynecologists.
    (b) Laboratory Procedures.--The Secretary may (directly and 
through grants to public and nonprofit private entities) carry 
out programs to provide for improvements in the quality of 
clinical-laboratory procedures regarding hepatitis C, including 
reducing variability in laboratory results on hepatitis C 
antibody and PCR testing.
    (c) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2001 through 2005.
              grants for lead poisoning related activities
    Sec. 317O. [247b-16] (a) Authority To Make Grants.--
            (1) In general.--The Secretary shall make grants to 
        States to support public health activities in States 
        and localities where data suggests that at least 5 
        percent of preschool-age children have an elevated 
        blood lead level through--
                    (A) effective, ongoing outreach and 
                community education targeted to families most 
                likely to be at risk for lead poisoning;
                    (B) individual family education activities 
                that are designed to reduce ongoing exposures 
                to lead for children with elevated blood lead 
                levels, including through home visits and 
                coordination with other programs designed to 
                identify and treat children at risk for lead 
                poisoning; and
                    (C) the development, coordination and 
                implementation of community-based approaches 
                for comprehensive lead poisoning prevention 
                from surveillance to lead hazard control.
            (2) State match.--A State is not eligible for a 
        grant under this section unless the State agrees to 
        expend (through State or local funds) $1 for every $2 
        provided under the grant to carry out the activities 
        described in paragraph (1).
            (3) Application.--To be eligible to receive a grant 
        under this section, a State shall submit an application 
        to the Secretary in such form and manner and containing 
        such information as the Secretary may require.
    (b) Coordination With Other Children's Programs.--A State 
shall identify in the application for a grant under this 
section how the State will coordinate operations and activities 
under the grant with--
            (1) other programs operated in the State that serve 
        children with elevated blood lead levels, including any 
        such programs operated under title V, XIX, or XXI of 
        the Social Security Act; and
            (2) one or more of the following--
                    (A) the child welfare and foster care and 
                adoption assistance programs under parts B and 
                E of title IV of such Act;
                    (B) the head start program established 
                under the Head Start Act (42 U.S.C. 9831 et 
                seq.);
                    (C) the program of assistance under the 
                special supplemental nutrition program for 
                women, infants and children (WIC) under section 
                17 of the Child Nutrition Act of 1966 (42 
                U.S.C. 1786);
                    (D) local public and private elementary or 
                secondary schools; or
                    (E) public housing agencies, as defined in 
                section 3 of the United States Housing Act of 
                1937 (42 U.S.C. 1437a).
    (c) Performance Measures.--The Secretary shall establish 
needs indicators and performance measures to evaluate the 
activities carried out under grants awarded under this section. 
Such indicators shall be commensurate with national measures of 
maternal and child health programs and shall be developed in 
consultation with the Director of the Centers for Disease 
Control and Prevention.
    (d) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section such sums as may 
be necessary for each of the fiscal years 2001 through 2005.

                HUMAN PAPILLOMAVIRUS (JOHANNA'S LAW) \1\
---------------------------------------------------------------------------

    \1\ The typeface of the parenthetical matter in the section heading 
probably should appear in light face and all small caps.
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    Sec. 317P. [247b-17] (a) Surveillance .--
            (1) In general.--The Secretary, acting through the 
        Centers for Disease Control and Prevention, shall--
                    (A) enter into cooperative agreements with 
                States and other entities to conduct sentinel 
                surveillance or other special studies that 
                would determine the prevalence in various age 
                groups and populations of specific types of 
                human papillomavirus (referred to in this 
                section as ``HPV'') in different sites in 
                various regions of the United States, through 
                collection of special specimens for HPV using a 
                variety of laboratory-based testing and 
                diagnostic tools; and
                    (B) develop and analyze data from the HPV 
                sentinel surveillance system described in 
                subparagraph (A).
            (2) Report.--The Secretary shall make a progress 
        report to the Congress with respect to paragraph (1) no 
        later than 1 year after the effective date of this 
        section.
    (b) Prevention Activities; Education Program.--
            (1) In general.--The Secretary, acting through the 
        Centers for Disease Control and Prevention, shall 
        conduct prevention research on HPV, including--
                    (A) behavioral and other research on the 
                impact of HPV-related diagnosis on individuals;
                    (B) formative research to assist with the 
                development of educational messages and 
                information for the public, for patients, and 
                for their partners about HPV;
                    (C) surveys of physician and public 
                knowledge, attitudes, and practices about 
                genital HPV infection; and
                    (D) upon the completion of and based on the 
                findings under subparagraphs (A) through (C), 
                develop and disseminate educational materials 
                for the public and health care providers 
                regarding HPV and its impact and prevention.
            (2) Report; final proposal.--The Secretary shall 
        make a progress report to the Congress with respect to 
        paragraph (1) not later than 1 year after the effective 
        date of this section, and shall develop a final report 
        not later than 3 years after such effective date, 
        including a detailed summary of the significant 
        findings and problems and the best strategies to 
        prevent future infections, based on available science.
    (c) HPV Education and Prevention.--
            (1) In general.--The Secretary shall prepare and 
        distribute educational materials for health care 
        providers and the public that include information on 
        HPV. Such materials shall address--
                    (A) modes of transmission;
                    (B) consequences of infection, including 
                the link between HPV and cervical cancer;
                    (C) the available scientific evidence on 
                the effectiveness or lack of effectiveness of 
                condoms in preventing infection with HPV; and
                    (D) the importance of regular Pap smears, 
                and other diagnostics for early intervention 
                and prevention of cervical cancer purposes in 
                preventing cervical cancer.
            (2) Medically accurate information.--Educational 
        material under paragraph (1), and all other relevant 
        educational and prevention materials prepared and 
        printed from this date forward for the public and 
        health care providers by the Secretary (including 
        materials prepared through the Food and Drug 
        Administration, the Centers for Disease Control and 
        Prevention, and the Health Resources and Services 
        Administration), or by contractors, grantees, or 
        subgrantees thereof, that are specifically designed to 
        address STDs including HPV shall contain medically 
        accurate information regarding the effectiveness or 
        lack of effectiveness of condoms in preventing the STD 
        the materials are designed to address. Such requirement 
        only applies to materials mass produced for the public 
        and health care providers, and not to routine 
        communications.
    (d) Johanna's Law.--
            (1) National public awareness campaign.--
                    (A) In general.--The Secretary shall carry 
                out a national campaign to increase the 
                awareness and knowledge of health care 
                providers and women with respect to gynecologic 
                cancers.
                    (B) Written materials.--Activities under 
                the national campaign under subparagraph (A) 
                shall include--
                            (i) maintaining a supply of written 
                        materials that provide information to 
                        the public on gynecologic cancers; and
                            (ii) distributing the materials to 
                        members of the public upon request.
                    (C) Public service announcements.--
                Activities under the national campaign under 
                subparagraph (A) shall, in accordance with 
                applicable law and regulations, include 
                developing and placing, in telecommunications 
                media, public service announcements intended to 
                encourage women to discuss with their 
                physicians their risks of gynecologic cancers. 
                Such announcements shall inform the public on 
                the manner in which the written materials 
                referred to in subparagraph (B) can be obtained 
                upon request, and shall call attention to early 
                warning signs and risk factors based on the 
                best available medical information.
            (2) Report and strategy.--
                    (A) Report.--Not later than 6 months after 
                the date of the enactment of this subsection, 
                the Secretary shall submit to the Congress a 
                report including the following:
                            (i) A description of the past and 
                        present activities of the Department of 
                        Health and Human Services to increase 
                        awareness and knowledge of the public 
                        with respect to different types of 
                        cancer, including gynecologic cancers.
                            (ii) A description of the past and 
                        present activities of the Department of 
                        Health and Human Services to increase 
                        awareness and knowledge of health care 
                        providers with respect to different 
                        types of cancer, including gynecologic 
                        cancers.
                            (iii) For each activity described 
                        pursuant to clause (i) or (ii), a 
                        description of the following:
                                    (I) The funding for such 
                                activity for fiscal year 2006 
                                and the cumulative funding for 
                                such activity for previous 
                                fiscal years.
                                    (II) The background and 
                                history of such activity, 
                                including--
                                            (aa) the goals of 
                                        such activity;
                                            (bb) the 
                                        communications 
                                        objectives of such 
                                        activity;
                                            (cc) the identity 
                                        of each agency within 
                                        the Department of 
                                        Health and Human 
                                        Services responsible 
                                        for any aspect of the 
                                        activity; and
                                            (dd) how such 
                                        activity is or was 
                                        expected to result in 
                                        change.
                                    (III) How long the activity 
                                lasted or is expected to last.
                                    (IV) The outcomes observed 
                                and the evaluation methods, if 
                                any, that have been, are being, 
                                or will be used with respect to 
                                such activity.
                                    (V) For each such outcome 
                                or evaluation method, a 
                                description of the associated 
                                results, analyses, and 
                                conclusions.
                    (B) Strategy.--
                            (i) Development; submission to 
                        congress.--Not later than 3 months 
                        after submitting the report required by 
                        subparagraph (A), the Secretary shall 
                        develop and submit to the Congress a 
                        strategy for improving efforts to 
                        increase awareness and knowledge of the 
                        public and health care providers with 
                        respect to different types of cancer, 
                        including gynecological cancers.
                            (ii) Consultation.--In developing 
                        the strategy under clause (i), the 
                        Secretary should consult with qualified 
                        private sector groups, including 
                        nonprofit organizations.
            (3) Full compliance.--
                    (A) In general.--Not later than March 1, 
                2008, the Secretary shall ensure that all 
                provisions of this section, including 
                activities directed to be carried out by the 
                Centers for Disease Control and Prevention and 
                the Food and Drug Administration, are fully 
                implemented and being complied with. Not later 
                than April 30, 2008, the Secretary shall submit 
                to Congress a report that certifies compliance 
                with the preceding sentence and that contains a 
                description of all activities undertaken to 
                achieve such compliance.
                    (B) If the Secretary fails to submit the 
                certification as provided for under 
                subparagraph (A), the Secretary shall, not 
                later than 3 months after the date on which the 
                report is to be submitted under subparagraph 
                (A), and every 3 months thereafter, submit to 
                Congress an explanation as to why the Secretary 
                has not yet complied with the first sentence of 
                subparagraph (A), a detailed description of all 
                actions undertaken within the month for which 
                the report is being submitted to bring the 
                Secretary into compliance with such sentence, 
                and the anticipated date the Secretary expects 
                to be in full compliance with such sentence.
            (4) Consultation with nonprofit gynecologic cancer 
        organizations.--In carrying out the national campaign 
        under this subsection, the Secretary shall consult with 
        nonprofit gynecologic cancer organizations, with a 
        mission both to conquer ovarian or other gynecologic 
        cancer and to provide outreach to State and local 
        governments and communities, for the purpose of 
        determining the best practices for providing 
        gynecologic cancer information and outreach services to 
        varied populations.
            (6) Authorization of appropriations.--For the 
        purpose of carrying out this subsection, there is 
        authorized to be appropriated $16,500,000 for the 
        period of fiscal years 2007 through 2009 and 
        $18,000,000 for the period of fiscal years 2012 through 
        2014.

SEC. 317Q. [247B-18] SURVEILLANCE AND RESEARCH REGARDING MUSCULAR 
                    DYSTROPHY.

    (a) In General.--The Secretary, acting through the Director 
of the Centers for Disease Control and Prevention, may award 
grants and cooperative agreements to public or nonprofit 
private entities (including health departments of States and 
political subdivisions of States, and including universities 
and other educational entities) for the collection, analysis, 
and reporting of data on Duchenne and other forms of muscular 
dystrophy. In making such awards, the Secretary may provide 
direct technical assistance in lieu of cash.
    (b) National Muscular Dystrophy Epidemiology Program.--The 
Secretary, acting through the Director of the Centers for 
Disease Control and Prevention, may award grants to public or 
nonprofit private entities (including health departments of 
States and political subdivisions of States, and including 
universities and other educational entities) for the purpose of 
carrying out epidemiological activities regarding Duchenne and 
other forms of muscular dystrophies, including collecting and 
analyzing information on the number, incidence, correlates, and 
symptoms of cases. In carrying out the preceding sentence, the 
Secretary shall provide for a national surveillance program. In 
making awards under this subsection, the Secretary may provide 
direct technical assistance in lieu of cash.
    (c) Coordination With Centers of Excellence.--The Secretary 
shall ensure that epidemiological information under subsections 
(a) and (b) is made available to centers of excellence 
supported under section 404E(b) by the Director of the National 
Institutes of Health.
    (d) Data.--In carrying out this section, the Secretary may 
ensure that any data on patients that is collected as part of 
the Muscular Dystrophy STARnet (under a grant under this 
section) is regularly updated to reflect changes in patient 
condition over time.
    (e) Reports and Study.--
            (1) Annual report.--Not later than 18 months after 
        the date of the enactment of the Paul D. Wellstone 
        Muscular Dystrophy Community Assistance, Research, and 
        Education Amendments of 2008, and annually thereafter, 
        the Director of the Centers for Disease Control and 
        Prevention shall submit to the appropriate committees 
        of the Congress a report--
                    (A) concerning the activities carried out 
                by MD STARnet site \1\ funded under this 
                section during the year for which the report is 
                prepared;
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    \1\ So in law. The term ``site'' probably should be ``sites''.
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                    (B) containing the data collected and 
                findings derived from the MD STARnet sites each 
                fiscal year (as funded under a grant under this 
                section during fiscal years 2008 through 2012); 
                and
                    (C) that every 2 years outlines prospective 
                data collection objectives and strategies.
            (2) Tracking health outcomes.--The Secretary may 
        provide health outcome data on the health and survival 
        of people with muscular dystrophy.
    (f) Authorization of Appropriations.--There are authorized 
to be appropriated such sums as may be necessary to carry out 
this section.

SEC. 317R. [247B-20] FOOD SAFETY GRANTS.

    (a) In General.--The Secretary may award grants to States 
and Indian tribes (as defined in section 4(e) of the Indian 
Self-Determination and Education Assistance Act (25 U.S.C. 
450b(e))) to expand participation in networks to enhance 
Federal, State, and local food safety efforts, including 
meeting the costs of establishing and maintaining the food 
safety surveillance, technical, and laboratory capacity needed 
for such participation.
    (b) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated $19,500,000 for fiscal year 2002, and such sums as 
may be necessary for each of the fiscal years 2003 through 
2006.

SEC. 317S. [247B-21] MOSQUITO-BORNE DISEASES; COORDINATION GRANTS TO 
                    STATES; ASSESSMENT AND CONTROL GRANTS TO POLITICAL 
                    SUBDIVISIONS.

    (a) Coordination Grants to States; Assessment Grants to 
Political Subdivisions.--
            (1) In general.--With respect to mosquito control 
        programs to prevent and control mosquito-borne diseases 
        (referred to in this section as ``control programs''), 
        the Secretary, acting through the Director of the 
        Centers for Disease Control and Prevention, may make 
        grants to States for the purpose of--
                    (A) coordinating control programs in the 
                State involved; and
                    (B) assisting such State in making grants 
                to political subdivisions of the State to 
                conduct assessments to determine the immediate 
                needs in such subdivisions for control 
                programs, and to develop, on the basis of such 
                assessments, plans for carrying out control 
                programs in the subdivisions.
            (2) Preference in making grants.--In making grants 
        under paragraph (1), the Secretary shall give 
        preference to States that have one or more political 
        subdivisions with an incidence, prevalence, or high 
        risk of mosquito-borne disease, or a population of 
        infected mosquitoes, that is substantial relative to 
        political subdivisions in other States.
            (3) Certain requirements.--A grant may be made 
        under paragraph (1) only if--
                    (A) the State involved has developed, or 
                agrees to develop, a plan for coordinating 
                control programs in the State, and the plan 
                takes into account any assessments or plans 
                described in subsection (b)(3) that have been 
                conducted or developed, respectively, by 
                political subdivisions in the State;
                    (B) in developing such plan, the State 
                consulted or will consult (as the case may be 
                under subparagraph (A)) with political 
                subdivisions in the State that are carrying out 
                or planning to carry out control programs;
                    (C) the State agrees to monitor control 
                programs in the State in order to ensure that 
                the programs are carried out in accordance with 
                such plan, with priority given to coordination 
                of control programs in political subdivisions 
                described in paragraph (2) that are contiguous;
                    (D) the State agrees that the State will 
                make grants to political subdivisions as 
                described in paragraph (1)(B), and that such a 
                grant will not exceed $10,000; and
                    (E) the State agrees that the grant will be 
                used to supplement, and not supplant, State and 
                local funds available for the purpose described 
                in paragraph (1).
            (4) Reports to secretary.--A grant may be made 
        under paragraph (1) only if the State involved agrees 
        that, promptly after the end of the fiscal year for 
        which the grant is made, the State will submit to the 
        Secretary a report that--
                    (A) describes the activities of the State 
                under the grant; and
                    (B) contains an evaluation of whether the 
                control programs of political subdivisions in 
                the State were effectively coordinated with 
                each other, which evaluation takes into account 
                any reports that the State received under 
                subsection (b)(5) from such subdivisions.
            (5) Number of grants.--A State may not receive more 
        than one grant under paragraph (1).
    (b) Prevention and Control Grants to Political 
Subdivisions.--
            (1) In general.--The Secretary, acting through the 
        Director of the Centers for Disease Control and 
        Prevention, may make grants to political subdivisions 
        of States or consortia of political subdivisions of 
        States, for the operation of control programs.
            (2) Preference in making grants.--In making grants 
        under paragraph (1), the Secretary shall give 
        preference to a political subdivision or consortium of 
        political subdivisions that--
                    (A) has--
                            (i) a history of elevated incidence 
                        or prevalence of mosquito-borne 
                        disease;
                            (ii) a population of infected 
                        mosquitoes; or
                            (iii) met criteria determined by 
                        the Secretary to suggest an increased 
                        risk of elevated incidence or 
                        prevalence of mosquito-borne disease in 
                        the pending fiscal year;
                    (B) demonstrates to the Secretary that such 
                political subdivision or consortium of 
                political subdivisions will, if appropriate to 
                the mosquito circumstances involved, 
                effectively coordinate the activities of the 
                control programs with contiguous political 
                subdivisions;
                    (C) demonstrates to the Secretary (directly 
                or through State officials) that the State in 
                which such a political subdivision or 
                consortium of political subdivisions is located 
                has identified or will identify geographic 
                areas in such State that have a significant 
                need for control programs and will effectively 
                coordinate such programs in such areas; and
                    (D) is located in a State that has received 
                a grant under subsection (a).
            (3) Requirement of assessment and plan.--A grant 
        may be made under paragraph (1) only if the political 
        subdivision or consortium of political subdivisions 
        involved--
                    (A) has conducted an assessment to 
                determine the immediate needs in such 
                subdivision or consortium for a control 
                program, including an entomological survey of 
                potential mosquito breeding areas; and
                    (B) has, on the basis of such assessment, 
                developed a plan for carrying out such a 
                program.
            (4) Requirement of matching funds.--
                    (A) In general.--With respect to the costs 
                of a control program to be carried out under 
                paragraph (1) by a political subdivision or 
                consortium of political subdivisions, a grant 
                under such paragraph may be made only if the 
                subdivision or consortium agrees to make 
                available (directly or through donations from 
                public or private entities) non-Federal 
                contributions toward such costs in an amount 
                that is not less than \1/3\ of such costs ($1 
                for each $2 of Federal funds provided in the 
                grant).
                    (B) Determination of amount contributed.--
                Non-Federal contributions required in 
                subparagraph (A) may be in cash or in kind, 
                fairly evaluated, including plant, equipment, 
                or services. Amounts provided by the Federal 
                Government, or services assisted or subsidized 
                to any significant extent by the Federal 
                Government, may not be included in determining 
                the amount of such non-Federal contributions.
                    (C) Waiver.--The Secretary may waive the 
                requirement established in subparagraph (A) if 
                the Secretary determines that extraordinary 
                economic conditions in the political 
                subdivision or consortium of political 
                subdivisions involved justify the waiver.
            (5) Reports to secretary.--A grant may be made 
        under paragraph (1) only if the political subdivision 
        or consortium of political subdivisions involved agrees 
        that, promptly after the end of the fiscal year for 
        which the grant is made, the subdivision or consortium 
        will submit to the Secretary, and to the State within 
        which the subdivision or consortium is located, a 
        report that describes the control program and contains 
        an evaluation of whether the program was effective.
            (6) Amount of grant; number of grants.--
                    (A) Amount of grant.--
                            (i) Single political subdivision.--
                        A grant under paragraph (1) awarded to 
                        a political subdivision for a fiscal 
                        year may not exceed $100,000.
                            (ii) Consortium.--A grant under 
                        paragraph (1) awarded to a consortium 
                        of 2 or more political subdivisions may 
                        not exceed $110,000 for each political 
                        subdivision. A consortium is not 
                        required to provide matching funds 
                        under paragraph (4) for any amounts 
                        received by such consortium in excess 
                        of amounts each political subdivision 
                        would have received separately.
                            (iii) Waiver of requirement.--A 
                        grant may exceed the maximum amount in 
                        clause (i) or (ii) if the Secretary 
                        determines that the geographical area 
                        covered by a political subdivision or 
                        consortium awarded a grant under 
                        paragraph (1) has an extreme need due 
                        to the size or density of--
                                    (I) the human population in 
                                such geographical area; or
                                    (II) the mosquito 
                                population in such geographical 
                                area.
                    (B) Number of grants.--A political 
                subdivision or a consortium of political 
                subdivisions may not receive more than one 
                grant under paragraph (1).
    (c) Applications for Grants.--A grant may be made under 
subsection (a) or (b) only if an application for the grant is 
submitted to the Secretary and the application is in such form, 
is made in such manner, and contains such agreements, 
assurances, and information as the Secretary determines to be 
necessary to carry out this section.
    (d) Technical Assistance.--Amounts appropriated under 
subsection (f) may be used by the Secretary to provide training 
and technical assistance with respect to the planning, 
development, and operation of assessments and plans under 
subsection (a) and control programs under subsection (b). The 
Secretary may provide such technical assistance directly or 
through awards of grants or contracts to public and private 
entities.
    (e) Definition of Political Subdivision.--In this section, 
the term ``political subdivision'' means the local political 
jurisdiction immediately below the level of State government, 
including counties, parishes, and boroughs. If State law 
recognizes an entity of general government that functions in 
lieu of, and is not within, a county, parish, or borough, the 
Secretary may recognize an area under the jurisdiction of such 
other entities of general government as a political subdivision 
for purposes of this section.
    (f) Authorization of Appropriations.--
            (1) In general.--For the purpose of carrying out 
        this section, there are authorized to be appropriated 
        $100,000,000 for fiscal year 2003, and such sums as may 
        be necessary for each of fiscal years 2004 through 
        2007.
            (2) Public health emergencies.--In the case of 
        control programs carried out in response to a mosquito-
        borne disease that constitutes a public health 
        emergency, the authorization of appropriations under 
        paragraph (1) is in addition to applicable 
        authorizations of appropriations under the Public 
        Health Security and Bioterrorism Preparedness and 
        Response Act of 2002.
            (3) Fiscal year 2004 appropriations.--For fiscal 
        year 2004, 50 percent or more of the funds appropriated 
        under paragraph (1) shall be used to award grants to 
        political subdivisions or consortia of political 
        subdivisions under subsection (b).

SEC. 317T. [247B-22] MICROBICIDE RESEARCH.

    (a) In General.--The Director of the Centers for Disease 
Control and Prevention is strongly encouraged to fully 
implement the Centers' microbicide agenda to support research 
and development of microbicides for use to prevent the 
transmission of the human immunodeficiency virus.
    (b) Authorization of Appropriations.--There are authorized 
to be appropriated such sums as may be necessary for each of 
fiscal years 2009 through 2013 to carry out this section.

   projects and programs for the prevention and control of sexually 
                        transmitted diseases \1\
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    \1\ Title II of Public Law 103-333, an appropriations Act, provides 
(under the heading relating to the Centers for Disease Control and 
Prevention; see 108 Stat. 2550) in part as follows: ``That funds 
appropriated under this heading for fiscal year 1995 and subsequent 
fiscal years shall be available for payment of the costs of medical 
care, related expenses, and burial expenses hereafter incurred by or on 
behalf of any person who had participated in the study of untreated 
syphilis initiated in Tuskegee, Alabama, in 1932, in such amounts and 
subject to such terms and conditions as prescribed by the Secretary of 
Health and Human Services and for payment, in such amounts and subject 
to such terms and conditions, of such costs and expenses hereafter 
incurred by or on behalf of such person's wife or offspring determined 
by the Secretary to have suffered injury or disease from syphilis 
contracted from such person''.
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    Sec. 318. [247c] (a) The Secretary may provide technical 
assistance to appropriate public and non-profit private 
entities and to scientific institutions for their research in, 
and training and public health programs for the prevention and 
control of sexually transmitted diseases.
    (b) The Secretary may make grants to States, political 
subdivisions of States, and any other public and nonprofit 
private entity for--
            (1) research into the prevention and control of 
        sexually transmitted diseases;
            (2) demonstration projects for the prevention and 
        control of sexually transmitted diseases;
            (3) public information and education programs for 
        the prevention and control of such diseases; and
            (4) education, training, and clinical skills 
        improvement activities in the prevention and control of 
        such diseases for health professionals (including 
        allied health personnel).
    (c) The Secretary is also authorized to make project grants 
to States and, in consultation with the State health authority, 
to political subdivisions of States, for--
            (1) sexually transmitted diseases surveillance 
        activities, including the reporting, screening, and 
        followup of diagnostic tests for, and diagnosed cases 
        of, sexually transmitted diseases;
            (2) casefinding and case followup activities 
        respecting sexually transmitted diseases, including 
        contact tracing of infectious cases of sexually 
        transmitted diseases and routine testing, including 
        laboratory tests and followup systems;
            (3) interstate epidemiologic referral and followup 
        activities respecting sexually transmitted diseases; 
        and
            (4) such special studies or demonstrations to 
        evaluate or test sexually transmitted diseases 
        prevention and control strategies and activities as may 
        be prescribed by the Secretary.
    (d) The Secretary may make grants to States and political 
subdivisions of States for the development, implementation, and 
evaluation of innovative, interdisciplinary approaches to the 
prevention and control of sexually transmitted diseases.
    (e)(1) For the purpose of making grants under subsections 
(b) through (d), there are authorized to be appropriated 
$85,000,000 for fiscal year 1994, and such sums as may be 
necessary for each of the fiscal years 1995 through 1998.
    (2) Each recipient of a grant under this section shall keep 
such records as the Secretary shall prescribe including records 
which fully disclose the amount and disposition by such 
recipient of the proceeds of such grant, the total cost of the 
project or undertaking in connection with which such grant was 
given or used and the amount of that portion of the cost of the 
project or undertaking supplied by other sources, and such 
other records as will facilitate an effective audit.
    (3) The Secretary and the Comptroller General of the United 
States, or any of their duly authorized representatives, shall 
have access for the purpose of audit and examination to any 
books, documents, papers, and records of the recipients of 
grants under this section that are pertinent to such grants.
    (4) The Secretary, at the request of a recipient of a grant 
under this section, may reduce such grant by the fair market 
value of any supplies or equipment furnished to such recipient 
and by the amount of pay, allowances, travel expenses, and any 
other costs in connection with the detail of an officer or 
employee of the United States to the recipient when the 
furnishing of such supplies or equipment or the detail of such 
an officer or employee is for the convenience of and at the 
request of such recipient and for the purpose of carrying out 
the program with respect to which the grant under this section 
is made. The amount by which any such grant is so reduced shall 
be available for payment by the Secretary of the costs incurred 
in furnishing the supplies, equipment, or personal services on 
which the reduction of such grant is based.
    (5) All information obtained in connection with the 
examination, care, or treatment of any individual under any 
program which is being carried out with a grant made under this 
section shall not, without such individual's consent, be 
disclosed except as may be necessary to provide service to him 
or as may be required by a law of a State or political 
subdivision of a State. Information derived from any such 
program may be disclosed--
            (A) in summary, statistical, or other form; or
            (B) for clinical or research purposes;
but only if the identity of the individuals diagnosed or 
provided care or treatment under such program is not disclosed.
    (f) Nothing in this section shall be construed to require 
any State or any political subdivision of a State to have a 
sexually transmitted diseases program which would require any 
person, who objects to any treatment provided under such a 
program, to be treated under such a program.

             INFERTILITY AND SEXUALLY TRANSMITTED DISEASES

    Sec. 318A. [247c-1] (a) In General.--The Secretary, acting 
through the Director of the Centers for Disease Control and 
Prevention, may make grants to States, political subdivisions 
of States, and other public or nonprofit private entities for 
the purpose of carrying out the activities described in 
subsection (c) regarding any treatable sexually transmitted 
disease that can cause infertility in women if treatment is not 
received for the disease.
    (b) Authority Regarding Individual Diseases.--With respect 
to diseases described in subsection (a), the Secretary shall, 
in making a grant under such subsection, specify the particular 
disease or diseases with respect to which the grant is to be 
made. The Secretary may not make the grant unless the applicant 
involved agrees to carry out this section only with respect to 
the disease or diseases so specified.
    (c) Authorized Activities.--With respect to any sexually 
transmitted disease described in subsection (a), the activities 
referred to in such subsection are--
            (1) screening women for the disease and for 
        secondary conditions resulting from the disease, 
        subject to compliance with criteria issued under 
        subsection (f);
            (2) providing treatment to women for the disease;
            (3) providing counseling to women on the prevention 
        and control of the disease (including, in the case of a 
        woman with the disease, counseling on the benefits of 
        locating and providing such counseling to any 
        individual from whom the woman may have contracted the 
        disease and any individual whom the woman may have 
        exposed to the disease);
            (4) providing follow-up services;
            (5) referrals for necessary medical services for 
        women screened pursuant to paragraph (1), including 
        referrals for evaluation and treatment with respect to 
        acquired immune deficiency syndrome and other sexually 
        transmitted diseases;
            (6) in the case of any woman receiving services 
        pursuant to any of paragraphs (1) through (5), 
        providing to the partner of the woman the services 
        described in such paragraphs, as appropriate;
            (7) providing outreach services to inform women of 
        the availability of the services described in 
        paragraphs (1) through (6);
            (8) providing to the public information and 
        education on the prevention and control of the disease, 
        including disseminating such information; and
            (9) providing training to health care providers in 
        carrying out the screenings and counseling described in 
        paragraphs (1) and (3).
    (d) Requirement of Availability of All Services Through 
Each Grantee.--The Secretary may make a grant under subsection 
(a) only if the applicant involved agrees that each activity 
authorized in subsection (c) will be available through the 
applicant. With respect to compliance with such agreement, the 
applicant may expend the grant to carry out any of the 
activities directly, and may expend the grant to enter into 
agreements with other public or nonprofit private entities 
under which the entities carry out the activities.
    (e) Required Providers Regarding Certain Services.--The 
Secretary may make a grant under subsection (a) only if the 
applicant involved agrees that, in expending the grant to carry 
out activities authorized in subsection (c), the services 
described in paragraphs (1) through (7) of such subsection will 
be provided only through entities that are State or local 
health departments, grantees under section 329, 330, 340A, or 
1001, or are other public or nonprofit private entities that 
provide health services to a significant number of low-income 
women.
    (f) Quality Assurance Regarding Screening for Diseases.--
For purposes of this section, the Secretary shall establish 
criteria for ensuring the quality of screening procedures for 
diseases described in subsection (a).
    (g) Confidentiality.--The Secretary may make a grant under 
subsection (a) only if the applicant involved agrees, subject 
to applicable law, to maintain the confidentiality of 
information on individuals with respect to activities carried 
out under subsection (c).
    (h) Limitation on Imposition of Fees for Services.--The 
Secretary may make a grant under subsection (a) only if the 
applicant involved agrees that, if a charge is imposed for the 
provision of services or activities under the grant, such 
charge--
            (1) will be made according to a schedule of charges 
        that is made available to the public;
            (2) will be adjusted to reflect the income of the 
        individual involved; and
            (3) will not be imposed on any individual with an 
        income of less than 150 percent of the official poverty 
        line, as established by the Director of the Office of 
        Management and Budget and revised by the Secretary in 
        accordance with section 673(2) of the Omnibus Budget 
        Reconciliation Act of 1981.
    (i) Limitations on Certain Expenditures.--The Secretary may 
make a grant under subsection (a) only if the applicant 
involved agrees that not less than 80 percent of the grant will 
be expended for the purpose of carrying out paragraphs (1) 
through (7) of subsection (c).
    (j) Reports to Secretary.--
            (1) Collection of data.--The Secretary may make a 
        grant under subsection (a) only if the applicant 
        involved agrees, with respect to any disease selected 
        under subsection (b) for the applicant, to submit to 
        the Secretary, for each fiscal year for which the 
        applicant receives such a grant, a report providing--
                    (A) the incidence of the disease among the 
                population of individuals served by the 
                applicant;
                    (B) the number and demographic 
                characteristics of individuals in such 
                population;
                    (C) the types of interventions and 
                treatments provided by the applicant, and the 
                health conditions with respect to which 
                referrals have been made pursuant to subsection 
                (c)(5);
                    (D) an assessment of the extent to which 
                the activities carried pursuant to subsection 
                (a) have reduced the incidence of infertility 
                in the geographic area involved; and
                    (E) such other information as the Secretary 
                may require with respect to the project carried 
                out with the grant.
            (2) Utility and comparability of data.--The 
        Secretary shall carry out activities for the purpose of 
        ensuring the utility and comparability of data 
        collected pursuant to paragraph (1).
    (k) Maintenance of Effort.--With respect to activities for 
which a grant under subsection (a) is authorized to be 
expended, the Secretary may make such a grant only if the 
applicant involved agrees to maintain expenditures of non-
Federal amounts for such activities at a level that is not less 
than the average level of such expenditures maintained by the 
applicant for the 2-year period preceding the fiscal year for 
which the applicant is applying to receive such a grant.
    (l) Requirement of Application.--
            (1) In general.--The Secretary may make a grant 
        under subsection (a) only if an application for the 
        grant is submitted to the Secretary, the application 
        contains the plan required in paragraph (2), and the 
        application is in such form, is made in such manner, 
        and contains such agreements, assurances, and 
        information as the Secretary determines to be necessary 
        to carry out this section.
            (2) Submission of plan for program of grantee.--
                    (A) In general.--The Secretary may make a 
                grant under subsection (a) only if the 
                applicant involved submits to the Secretary a 
                plan describing the manner in which the 
                applicant will comply with the agreements 
                required as a condition of receiving such a 
                grant, including a specification of the 
                entities through which activities authorized in 
                subsection (c) will be provided.
                    (B) Participation of certain entities.--The 
                Secretary may make a grant under subsection (a) 
                only if the applicant provides assurances 
                satisfactory to the Secretary that the plan 
                submitted under subparagraph (A) has been 
                prepared in consultation with an appropriate 
                number and variety of--
                            (i) representatives of entities in 
                        the geographic area involved that 
                        provide services for the prevention and 
                        control of sexually transmitted 
                        diseases, including programs to provide 
                        to the public information and education 
                        regarding such diseases; and
                            (ii) representatives of entities in 
                        such area that provide family planning 
                        services.
    (m) Duration of Grant.--The period during which payments 
are made to an entity from a grant under subsection (a) may not 
exceed 3 years. The provision of such payments shall be subject 
to annual approval by the Secretary of the payments and subject 
to the availability of appropriations for the fiscal year 
involved to make the payments in such year. The preceding 
sentence may not be construed to establish a limitation on the 
number of grants under such subsection that may be made to an 
entity.
    (n) Technical Assistance, and Supplies and Services in Lieu 
of Grant Funds.--
            (1) Technical assistance.--The Secretary may 
        provide training and technical assistance to grantees 
        under subsection (a) with respect to the planning, 
        development, and operation of any program or service 
        carried out under such subsection. The Secretary may 
        provide such technical assistance directly or through 
        grants or contracts.
            (2) Supplies, equipment, and employee detail.--The 
        Secretary, at the request of a recipient of a grant 
        under subsection (a), may reduce the amount of such 
        grant by--
                    (A) the fair market value of any supplies 
                or equipment furnished the grant recipient; and
                    (B) the amount of the pay, allowances, and 
                travel expenses of any officer or employee of 
                the Government when detailed to the grant 
                recipient and the amount of any other costs 
                incurred in connection with the detail of such 
                officer or employee;
        when the furnishing of such supplies or equipment or 
        the detail of such an officer or employee is for the 
        convenience of and at the request of such grant 
        recipient and for the purpose of carrying out a program 
        with respect to which the grant under subsection (a) is 
        made. The amount by which any such grant is so reduced 
        shall be available for payment by the Secretary of the 
        costs incurred in furnishing the supplies or equipment, 
        or in detailing the personnel, on which the reduction 
        of such grant is based, and such amount shall be deemed 
        as part of the grant and shall be deemed to have been 
        paid to the grant recipient.
    (o) Evaluations and Reports by Secretary.--
            (1) Evaluations.--The Secretary shall, directly or 
        through contracts with public or private entities, 
        provide for annual evaluations of programs carried out 
        pursuant to subsection (a) in order to determine the 
        quality and effectiveness of the programs.
            (2) Report to congress.--Not later than 1 year 
        after the date on which amounts are first appropriated 
        pursuant to subsection (q), and biennially thereafter, 
        the Secretary shall submit to the Committee on Energy 
        and Commerce of the House of Representatives, and to 
        the Committee on Labor and Human Resources of the 
        Senate, a report--
                    (A) summarizing the information provided to 
                the Secretary in reports made pursuant to 
                subsection (j)(1), including information on the 
                incidence of sexually transmitted diseases 
                described in subsection (a); and
                    (B) summarizing evaluations carried out 
                pursuant to paragraph (1) during the preceding 
                fiscal year.
    (p) Coordination of Federal Programs.--The Secretary shall 
coordinate the program carried out under this section with any 
similar programs administered by the Secretary (including 
coordination between the Director of the Centers for Disease 
Control and Prevention and the Director of the National 
Institutes of Health).
    (q) Authorization of Appropriations.--For the purpose of 
carrying out this section, other than subsections (o) and (r), 
there are authorized to be appropriated $25,000,000 for fiscal 
year 1993, and such sums as may be necessary for each of the 
fiscal years 1994 through 1998.
    (r) Separate  Grants  for  Research  on  Delivery  of 
Services.--
            (1) In general.--The Secretary may make grants for 
        the purpose of conducting research on the manner in 
        which the delivery of services under subsection (a) may 
        be improved. The Secretary may make such grants only to 
        grantees under such subsection and to public and 
        nonprofit private entities that are carrying out 
        programs substantially similar to programs carried out 
        under such subsection.
            (2) Authorization of appropriations.--For the 
        purpose of carrying out paragraph (1), there are 
        authorized to be appropriated such sums as may be 
        necessary for each of the fiscal years 1993 through 
        1998.
          data collection regarding programs under title xxvi
    Sec. 318B. [247c-2] For the purpose of collecting and 
providing data for program planning and evaluation activities 
under title XXVI, there are authorized to be appropriated to 
the Secretary (acting through the Director of the Centers for 
Disease Control and Prevention) such sums as may be necessary 
for each of the fiscal years 2001 through 2005. Such 
authorization of appropriations is in addition to other 
authorizations of appropriations that are available for such 
purpose.

SEC. 319. [247D] PUBLIC HEALTH EMERGENCIES.

    (a) Emergencies.--If the Secretary determines, after 
consultation with such public health officials as may be 
necessary, that--
            (1) a disease or disorder presents a public health 
        emergency; or
            (2) a public health emergency, including 
        significant outbreaks of infectious diseases or 
        bioterrorist attacks, otherwise exists,
the Secretary may take such action as may be appropriate to 
respond to the public health emergency, including making 
grants, providing awards for expenses, and entering into 
contracts and conducting and supporting investigations into the 
cause, treatment, or prevention of a disease or disorder as 
described in paragraphs (1) and (2). Any such determination of 
a public health emergency terminates upon the Secretary 
declaring that the emergency no longer exists, or upon the 
expiration of the 90-day period beginning on the date on which 
the determination is made by the Secretary, whichever occurs 
first. Determinations that terminate under the preceding 
sentence may be renewed by the Secretary (on the basis of the 
same or additional facts), and the preceding sentence applies 
to each such renewal. Not later than 48 hours after making a 
determination under this subsection of a public health 
emergency (including a renewal), the Secretary shall submit to 
the Congress written notification of the determination.
    (b) Public Health Emergency Fund.--
            (1) In general.--There is established in the 
        Treasury a fund to be designated as the ``Public Health 
        Emergency Fund'' to be made available to the Secretary 
        without fiscal year limitation to carry out subsection 
        (a) only if a public health emergency has been declared 
        by the Secretary under such subsection. There is 
        authorized to be appropriated to the Fund such sums as 
        may be necessary.
            (2) Report.--Not later than 90 days after the end 
        of each fiscal year, the Secretary shall prepare and 
        submit to the Committee on Health, Education, Labor, 
        and Pensions and the Committee on Appropriations of the 
        Senate and the Committee on Commerce and the Committee 
        on Appropriations of the House of Representatives a 
        report describing--
                    (A) the expenditures made from the Public 
                Health Emergency Fund in such fiscal year; and
                    (B) each public health emergency for which 
                the expenditures were made and the activities 
                undertaken with respect to each emergency which 
                was conducted or supported by expenditures from 
                the Fund.
    (c) Supplement Not Supplant.--Funds appropriated under this 
section shall be used to supplement and not supplant other 
Federal, State, and local public funds provided for activities 
under this section.
    (d) Data Submittal and Reporting Deadlines.--In any case in 
which the Secretary determines that, wholly or partially as a 
result of a public health emergency that has been determined 
pursuant to subsection (a), individuals or public or private 
entities are unable to comply with deadlines for the submission 
to the Secretary of data or reports required under any law 
administered by the Secretary, the Secretary may, 
notwithstanding any other provision of law, grant such 
extensions of such deadlines as the circumstances reasonably 
require, and may waive, wholly or partially, any sanctions 
otherwise applicable to such failure to comply. Before or 
promptly after granting such an extension or waiver, the 
Secretary shall notify the Congress of such action and publish 
in the Federal Register a notice of the extension or waiver.

SEC. 319A. [247D-1] VACCINE TRACKING AND DISTRIBUTION.

    (a) Tracking.--The Secretary, together with relevant 
manufacturers, wholesalers, and distributors as may agree to 
cooperate, may track the initial distribution of federally 
purchased influenza vaccine in an influenza pandemic. Such 
tracking information shall be used to inform Federal, State, 
local, and tribal decision makers during an influenza pandemic.
    (b) Distribution.--The Secretary shall promote 
communication between State, local, and tribal public health 
officials and such manufacturers, wholesalers, and distributors 
as agree to participate, regarding the effective distribution 
of seasonal influenza vaccine. Such communication shall include 
estimates of high priority populations, as determined by the 
Secretary, in State, local, and tribal jurisdictions in order 
to inform Federal, State, local, and tribal decision makers 
during vaccine shortages and supply disruptions.
    (c) Confidentiality.--The information submitted to the 
Secretary or its contractors, if any, under this section or 
under any other section of this Act related to vaccine 
distribution information shall remain confidential in 
accordance with the exception from the public disclosure of 
trade secrets, commercial or financial information, and 
information obtained from an individual that is privileged and 
confidential, as provided for in section 552(b)(4) of title 5, 
United States Code, and subject to the penalties and exceptions 
under sections 1832 and 1833 of title 18, United States Code, 
relating to the protection and theft of trade secrets, and 
subject to privacy protections that are consistent with the 
regulations promulgated under section 264(c) of the Health 
Insurance Portability and Accountability Act of 1996. None of 
such information provided by a manufacturer, wholesaler, or 
distributor shall be disclosed without its consent to another 
manufacturer, wholesaler, or distributor, or shall be used in 
any manner to give a manufacturer, wholesaler, or distributor a 
proprietary advantage.
    (d) Guidelines.--The Secretary, in order to maintain the 
confidentiality of relevant information and ensure that none of 
the information contained in the systems involved may be used 
to provide proprietary advantage within the vaccine market, 
while allowing State, local, and tribal health officials access 
to such information to maximize the delivery and availability 
of vaccines to high priority populations, during times of 
influenza pandemics, vaccine shortages, and supply disruptions, 
in consultation with manufacturers, distributors, wholesalers 
and State, local, and tribal health departments, shall develop 
guidelines for subsections (a) and (b).
    (e) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section, such sums for 
each of fiscal years 2007 through 2011.
    (f) Report to Congress.--As part of the National Health 
Security Strategy described in section 2802, the Secretary 
shall provide an update on the implementation of subsections 
(a) through (d).

SEC. 319C-1. [247D-3A] IMPROVING STATE AND LOCAL PUBLIC HEALTH 
                    SECURITY. \1\
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    \1\ Former sections 319B and 319C were repealed by section 
204(b)(1) of Public Law 109-417 (120 Stat. 2951).
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    (a) In General.--To enhance the security of the United 
States with respect to public health emergencies, the Secretary 
shall award cooperative agreements to eligible entities to 
enable such entities to conduct the activities described in 
subsection (d).
    (b) Eligible Entities.--To be eligible to receive an award 
under subsection (a), an entity shall--
            (1)(A) be a State;
            (B) be a political subdivision determined by the 
        Secretary to be eligible for an award under this 
        section (based on criteria described in subsection 
        (i)(4)); or
            (C) be a consortium of entities described in 
        subparagraph (A); and
            (2) prepare and submit to the Secretary an 
        application at such time, and in such manner, and 
        containing such information as the Secretary may 
        require, including--
                    (A) an All-Hazards Public Health Emergency 
                Preparedness and Response Plan which shall 
                include--
                            (i) a description of the activities 
                        such entity will carry out under the 
                        agreement to meet the goals identified 
                        under section 2802;
                            (ii) a pandemic influenza plan 
                        consistent with the requirements of 
                        paragraphs (2) and (5) of subsection 
                        (g);
                            (iii) preparedness and response 
                        strategies and capabilities that take 
                        into account the medical and public 
                        health needs of at-risk individuals in 
                        the event of a public health emergency;
                            (iv) a description of the mechanism 
                        the entity will implement to utilize 
                        the Emergency Management Assistance 
                        Compact or other mutual aid agreements 
                        for medical and public health mutual 
                        aid; and
                            (v) a description of how the entity 
                        will include the State Unit on Aging in 
                        public health emergency preparedness;
                    (B) an assurance that the entity will 
                report to the Secretary on an annual basis (or 
                more frequently as determined by the Secretary) 
                on the evidence-based benchmarks and objective 
                standards established by the Secretary to 
                evaluate the preparedness and response 
                capabilities of such entity under subsection 
                (g);
                    (C) an assurance that the entity will 
                conduct, on at least an annual basis, an 
                exercise or drill that meets any criteria 
                established by the Secretary to test the 
                preparedness and response capabilities of such 
                entity, and that the entity will report back to 
                the Secretary within the application of the 
                following year on the strengths and weaknesses 
                identified through such exercise or drill, and 
                corrective actions taken to address material 
                weaknesses;
                    (D) an assurance that the entity will 
                provide to the Secretary the data described 
                under section 319D(d)(3) as determined feasible 
                by the Secretary;
                    (E) an assurance that the entity will 
                conduct activities to inform and educate the 
                hospitals within the jurisdiction of such 
                entity on the role of such hospitals in the 
                plan required under subparagraph (A);
                    (F) an assurance that the entity, with 
                respect to the plan described under 
                subparagraph (A), has developed and will 
                implement an accountability system to ensure 
                that such entity make satisfactory annual 
                improvement and describe such system in the 
                plan under subparagraph (A);
                    (G) a description of the means by which to 
                obtain public comment and input on the plan 
                described in subparagraph (A) and on the 
                implementation of such plan, that shall include 
                an advisory committee or other similar 
                mechanism for obtaining comment from the public 
                and from other State, local, and tribal 
                stakeholders; and
                    (H) as relevant, a description of the 
                process used by the entity to consult with 
                local departments of public health to reach 
                consensus, approval, or concurrence on the 
                relative distribution of amounts received under 
                this section.
    (c) Limitation.--Beginning in fiscal year 2009, the 
Secretary may not award a cooperative agreement to a State 
unless such State is a participant in the Emergency System for 
Advance Registration of Volunteer Health Professionals 
described in section 319I.
    (d) Use of Funds.--
            (1) In general.--An award under subsection (a) 
        shall be expended for activities to achieve the 
        preparedness goals described under paragraphs (1), (2), 
        (4), (5), and (6) of section 2802(b).
            (2) Effect of section.--Nothing in this subsection 
        may be construed as establishing new regulatory 
        authority or as modifying any existing regulatory 
        authority.
    (e) Coordination With Local Response Capabilities.--An 
entity shall, to the extent practicable, ensure that activities 
carried out under an award under subsection (a) are coordinated 
with activities of relevant Metropolitan Medical Response 
Systems, local public health departments, the Cities Readiness 
Initiative, and local emergency plans.
    (f) Consultation With Homeland Security.--In making awards 
under subsection (a), the Secretary shall consult with the 
Secretary of Homeland Security to--
            (1) ensure maximum coordination of public health 
        and medical preparedness and response activities with 
        the Metropolitan Medical Response System, and other 
        relevant activities;
            (2) minimize duplicative funding of programs and 
        activities;
            (3) analyze activities, including exercises and 
        drills, conducted under this section to develop 
        recommendations and guidance on best practices for such 
        activities; and
            (4) disseminate such recommendations and guidance, 
        including through expanding existing lessons learned 
        information systems to create a single Internet-based 
        point of access for sharing and distributing medical 
        and public health best practices and lessons learned 
        from drills, exercises, disasters, and other 
        emergencies.
    (g) Achievement of Measurable Evidence-Based Benchmarks and 
Objective Standards.--
            (1) In general.--Not later than 180 days after the 
        date of enactment of the Pandemic and All-Hazards 
        Preparedness Act, the Secretary shall develop or where 
        appropriate adopt, and require the application of, 
        measurable evidence-based benchmarks and objective 
        standards that measure levels of preparedness with 
        respect to the activities described in this section and 
        with respect to activities described in section 319C-2. 
        In developing such benchmarks and standards, the 
        Secretary shall consult with and seek comments from 
        State, local, and tribal officials and private 
        entities, as appropriate. Where appropriate, the 
        Secretary shall incorporate existing objective 
        standards. Such benchmarks and standards shall--
                    (A) include outcome goals representing 
                operational achievement of the National 
                Preparedness Goals developed under section 
                2802(b); and
                    (B) at a minimum, require entities to--
                            (i) measure progress toward 
                        achieving the outcome goals; and
                            (ii) at least annually, test, 
                        exercise, and rigorously evaluate the 
                        public health and medical emergency 
                        preparedness and response capabilities 
                        of the entity, and report to the 
                        Secretary on such measured and tested 
                        capabilities and measured and tested 
                        progress toward achieving outcome 
                        goals, based on criteria established by 
                        the Secretary.
            (2) Criteria for pandemic influenza plans.--
                    (A) In general.--Not later than 180 days 
                after the date of enactment of the Pandemic and 
                All-Hazards Preparedness Act, the Secretary 
                shall develop and disseminate to the chief 
                executive officer of each State criteria for an 
                effective State plan for responding to pandemic 
                influenza.
                    (B) Rule of construction.--Nothing in this 
                section shall be construed to require the 
                duplication of Federal efforts with respect to 
                the development of criteria or standards, 
                without regard to whether such efforts were 
                carried out prior to or after the date of 
                enactment of this section.
            (3) Technical assistance.--The Secretary shall, as 
        determined appropriate by the Secretary, provide to a 
        State, upon request, technical assistance in meeting 
        the requirements of this section, including the 
        provision of advice by experts in the development of 
        high-quality assessments, the setting of State 
        objectives and assessment methods, the development of 
        measures of satisfactory annual improvement that are 
        valid and reliable, and other relevant areas.
            (4) Notification of failures.--The Secretary shall 
        develop and implement a process to notify entities that 
        are determined by the Secretary to have failed to meet 
        the requirements of paragraph (1) or (2). Such process 
        shall provide such entities with the opportunity to 
        correct such noncompliance. An entity that fails to 
        correct such noncompliance shall be subject to 
        paragraph (5).
            (5) Withholding of amounts from entities that fail 
        to achieve benchmarks or submit influenza plan.--
        Beginning with fiscal year 2009, and in each succeeding 
        fiscal year, the Secretary shall--
                    (A) withhold from each entity that has 
                failed substantially to meet the benchmarks and 
                performance measures described in paragraph (1) 
                for the immediately preceding fiscal year 
                (beginning with fiscal year 2008), pursuant to 
                the process developed under paragraph (4), the 
                amount described in paragraph (6); and
                    (B) withhold from each entity that has 
                failed to submit to the Secretary a plan for 
                responding to pandemic influenza that meets the 
                criteria developed under paragraph (2), the 
                amount described in paragraph (6).
            (6) Amounts described.--
                    (A) In general.--The amounts described in 
                this paragraph are the following amounts that 
                are payable to an entity for activities 
                described in section 319C-1 or 319C-2:
                            (i) For the fiscal year immediately 
                        following a fiscal year in which an 
                        entity experienced a failure described 
                        in subparagraph (A) or (B) of paragraph 
                        (5) by the entity, an amount equal to 
                        10 percent of the amount the entity was 
                        eligible to receive for such fiscal 
                        year.
                            (ii) For the fiscal year 
                        immediately following two consecutive 
                        fiscal years in which an entity 
                        experienced such a failure, an amount 
                        equal to 15 percent of the amount the 
                        entity was eligible to receive for such 
                        fiscal year, taking into account the 
                        withholding of funds for the 
                        immediately preceding fiscal year under 
                        clause (i).
                            (iii) For the fiscal year 
                        immediately following three consecutive 
                        fiscal years in which an entity 
                        experienced such a failure, an amount 
                        equal to 20 percent of the amount the 
                        entity was eligible to receive for such 
                        fiscal year, taking into account the 
                        withholding of funds for the 
                        immediately preceding fiscal years 
                        under clauses (i) and (ii).
                            (iv) For the fiscal year 
                        immediately following four consecutive 
                        fiscal years in which an entity 
                        experienced such a failure, an amount 
                        equal to 25 percent of the amount the 
                        entity was eligible to receive for such 
                        a fiscal year, taking into account the 
                        withholding of funds for the 
                        immediately preceding fiscal years 
                        under clauses (i), (ii), and (iii).
                    (B) Separate accounting.--Each failure 
                described in subparagraph (A) or (B) of 
                paragraph (5) shall be treated as a separate 
                failure for purposes of calculating amounts 
                withheld under subparagraph (A).
            (7) Reallocation of amounts withheld.--
                    (A) In general.--The Secretary shall make 
                amounts withheld under paragraph (6) available 
                for making awards under section 319C-2 to 
                entities described in subsection (b)(1) of such 
                section.
                    (B) Preference in reallocation.--In making 
                awards under section 319C-2 with amounts 
                described in subparagraph (A), the Secretary 
                shall give preference to eligible entities (as 
                described in section 319C-2(b)(1)) that are 
                located in whole or in part in States from 
                which amounts have been withheld under 
                paragraph (6).
            (8) Waive or reduce withholding.--The Secretary may 
        waive or reduce the withholding described in paragraph 
        (6), for a single entity or for all entities in a 
        fiscal year, if the Secretary determines that 
        mitigating conditions exist that justify the waiver or 
        reduction.
    (h) Grants for Real-Time Disease Detection Improvement.--
            (1) In general.--The Secretary may award grants to 
        eligible entities to carry out projects described under 
        paragraph (4).
            (2) Eligible entity.--For purposes of this section, 
        the term ``eligible entity'' means an entity that is--
                    (A)(i) a hospital, clinical laboratory, 
                university; or
                    (ii) a poison control center or 
                professional organization in the field of 
                poison control; and
                    (B) a participant in the network 
                established under subsection 319D(d).
            (3) Application.--Each eligible entity desiring a 
        grant under this subsection shall submit to the 
        Secretary an application at such time, in such manner, 
        and containing such information as the Secretary may 
        require.
            (4) Use of funds.--
                    (A) In general.--An eligible entity 
                described in paragraph (2)(A)(i) that receives 
                a grant under this subsection shall use the 
                funds awarded pursuant to such grant to carry 
                out a pilot demonstration project to purchase 
                and implement the use of advanced diagnostic 
                medical equipment to analyze real-time clinical 
                specimens for pathogens of public health or 
                bioterrorism significance and report any 
                results from such project to State, local, and 
                tribal public health entities and the network 
                established under section 319D(d).
                    (B) Other entities.--An eligible entity 
                described in paragraph (2)(A)(ii) that receives 
                a grant under this section shall use the funds 
                awarded pursuant to such grant to--
                            (i) improve the early detection, 
                        surveillance, and investigative 
                        capabilities of poison control centers 
                        for chemical, biological, radiological, 
                        and nuclear events by training poison 
                        information personnel to improve the 
                        accuracy of surveillance data, 
                        improving the definitions used by the 
                        poison control centers for 
                        surveillance, and enhancing timely and 
                        efficient investigation of data 
                        anomalies;
                            (ii) improve the capabilities of 
                        poison control centers to provide 
                        information to health care providers 
                        and the public with regard to chemical, 
                        biological, radiological, or nuclear 
                        threats or exposures, in consultation 
                        with the appropriate State, local, and 
                        tribal public health entities; or
                            (iii) provide surge capacity in the 
                        event of a chemical, biological, 
                        radiological, or nuclear event through 
                        the establishment of alternative poison 
                        control center worksites and the 
                        training of nontraditional personnel.
    (i) Funding.--
            (1) Authorization of appropriations.--
                    (A) In general.--For the purpose of 
                carrying out this section, there is authorized 
                to be appropriated $824,000,000 for fiscal year 
                2007, of which $35,000,000 shall be used to 
                carry out subsection (h), for awards pursuant 
                to paragraph (3) (subject to the authority of 
                the Secretary to make awards pursuant to 
                paragraphs (4) and (5)), and such sums as may 
                be necessary for each of fiscal years 2008 
                through 2011.
                    (B) Coordination.--There are authorized to 
                be appropriated, $10,000,000 for fiscal year 
                2007 to carry out subsection (f)(4) of this 
                section and section 2814.
                    (C) Requirement for state matching funds.--
                Beginning in fiscal year 2009, in the case of 
                any State or consortium of two or more States, 
                the Secretary may not award a cooperative 
                agreement under this section unless the State 
                or consortium of States agree that, with 
                respect to the amount of the cooperative 
                agreement awarded by the Secretary, the State 
                or consortium of States will make available 
                (directly or through donations from public or 
                private entities) non-Federal contributions in 
                an amount equal to--
                            (i) for the first fiscal year of 
                        the cooperative agreement, not less 
                        than 5 percent of such costs ($1 for 
                        each $20 of Federal funds provided in 
                        the cooperative agreement); and
                            (ii) for any second fiscal year of 
                        the cooperative agreement, and for any 
                        subsequent fiscal year of such 
                        cooperative agreement, not less than 10 
                        percent of such costs ($1 for each $10 
                        of Federal funds provided in the 
                        cooperative agreement).
                    (D) Determination of amount of non-federal 
                contributions.--As determined by the Secretary, 
                non-Federal contributions required in 
                subparagraph (C) may be provided directly or 
                through donations from public or private 
                entities and may be in cash or in kind, fairly 
                evaluated, including plant, equipment or 
                services. Amounts provided by the Federal 
                government, or services assisted or subsidized 
                to any significant extent by the Federal 
                government, may not be included in determining 
                the amount of such non-Federal contributions.
            (2) Maintaining state funding.--
                    (A) In general.--An entity that receives an 
                award under this section shall maintain 
                expenditures for public health security at a 
                level that is not less than the average level 
                of such expenditures maintained by the entity 
                for the preceding 2 year period.
                    (B) Rule of construction.--Nothing in this 
                section shall be construed to prohibit the use 
                of awards under this section to pay salary and 
                related expenses of public health and other 
                professionals employed by State, local, or 
                tribal public health agencies who are carrying 
                out activities supported by such awards 
                (regardless of whether the primary assignment 
                of such personnel is to carry out such 
                activities).
            (3) Determination of amount.--
                    (A) In general.--The Secretary shall award 
                cooperative agreements under subsection (a) to 
                each State or consortium of 2 or more States 
                that submits to the Secretary an application 
                that meets the criteria of the Secretary for 
                the receipt of such an award and that meets 
                other implementation conditions established by 
                the Secretary for such awards
                    (B) Base amount.--In determining the amount 
                of an award pursuant to subparagraph (A) for a 
                State, the Secretary shall first determine an 
                amount the Secretary considers appropriate for 
                the State (referred to in this paragraph as the 
                ``base amount''), except that such amount may 
                not be greater than the minimum amount 
                determined under subparagraph (D).
                    (C) Increase on basis of population.--After 
                determining the base amount for a State under 
                subparagraph (B), the Secretary shall increase 
                the base amount by an amount equal to the 
                product of--
                            (i) the amount appropriated under 
                        paragraph (1)(A)(i)(I) for the fiscal 
                        year, less an amount equal to the sum 
                        of all base amounts determined for the 
                        States under subparagraph (B), and less 
                        the amount, if any, reserved by the 
                        Secretary under paragraphs (4) and (5); 
                        and
                            (ii) subject to paragraph (4)(C), 
                        the percentage constituted by the ratio 
                        of an amount equal to the population of 
                        the State over an amount equal to the 
                        total population of the States (as 
                        indicated by the most recent data 
                        collected by the Bureau of the Census).
                    (D) Minimum amount.--Subject to the amount 
                appropriated under paragraph (1)(A)(i)(I), an 
                award pursuant to subparagraph (A) for a State 
                shall be the greater of the base amount as 
                increased under subparagraph (C), or the 
                minimum amount under this subparagraph. The 
                minimum amount under this subparagraph is--
                            (i) in the case of each of the 
                        several States, the District of 
                        Columbia, and the Commonwealth of 
                        Puerto Rico, an amount equal to the 
                        lesser of--
                                    (I) $5,000,000; or
                                    (II) if the amount 
                                appropriated under paragraph 
                                (1)(A)(i)(I) is less than 
                                $667,000,000, an amount equal 
                                to 0.75 percent of the amount 
                                appropriated under such 
                                paragraph, less the amount, if 
                                any, reserved by the Secretary 
                                under paragraphs (4) and (5); 
                                or
                            (ii) in the case of each of 
                        American Samoa, Guam, the Commonwealth 
                        of the Northern Mariana Islands, and 
                        the Virgin Islands, an amount 
                        determined by the Secretary to be 
                        appropriate, except that such amount 
                        may not exceed the amount determined 
                        under clause (i).
            (4) Certain political subdivisions.--
                    (A) In general.--For fiscal year 2007, the 
                Secretary may, before making awards pursuant to 
                paragraph (3) for such year, reserve from the 
                amount appropriated under paragraph (1) for the 
                year an amount determined necessary by the 
                Secretary to make awards under subsection (a) 
                to political subdivisions that have a 
                substantial number of residents, have a 
                substantial local infrastructure for responding 
                to public health emergencies, and face a high 
                degree of risk from bioterrorist attacks or 
                other public health emergencies. Not more than 
                three political subdivisions may receive awards 
                pursuant to this subparagraph.
                    (B) Coordination with statewide plans.--An 
                award pursuant to subparagraph (A) may not be 
                made unless the application of the political 
                subdivision involved is in coordination with, 
                and consistent with, applicable Statewide plans 
                described in subsection (c).
                    (C) Relationship to formula grants.--In the 
                case of a State that will receive an award 
                pursuant to paragraph (3), and in which there 
                is located a political subdivision that will 
                receive an award pursuant to subparagraph (A), 
                the Secretary shall, in determining the amount 
                under paragraph (3)(C) for the State, subtract 
                from the population of the State an amount 
                equal to the population of such political 
                subdivision.
                    (D) Continuity of funding.--In determining 
                whether to make an award pursuant to 
                subparagraph (A) to a political subdivision, 
                the Secretary may consider, as a factor 
                indicating that the award should be made, that 
                the political subdivision received public 
                health funding from the Secretary for fiscal 
                year 2006.
            (5) Significant unmet needs; degree of risk.--
                    (A) In general.--For fiscal year 2007, the 
                Secretary may, before making awards pursuant to 
                paragraph (3) for such year, reserve from the 
                amount appropriated under paragraph (1) for the 
                year an amount determined necessary by the 
                Secretary to make awards under subsection (a) 
                to eligible entities that--
                            (i) have a significant need for 
                        funds to build capacity to identify, 
                        detect, monitor, and respond to a 
                        bioterrorist or other threat to the 
                        public health, which need will not be 
                        met by awards pursuant to paragraph 
                        (3); and
                            (ii) face a particularly high 
                        degree of risk of such a threat.
                    (B) Recipients of grants.--Awards pursuant 
                to subparagraph (A) may be supplemental awards 
                to States that receive awards pursuant to 
                paragraph (3), or may be awards to eligible 
                entities described in subsection (b)(1)(B) 
                within such States.
                    (C) Finding with respect to district of 
                columbia.--The Secretary shall consider the 
                District of Columbia to have a significant 
                unmet need for purposes of subparagraph (A), 
                and to face a particularly high degree of risk 
                for such purposes, on the basis of the 
                concentration of entities of national 
                significance located within the District.
            (6) Funding of local entities.--The Secretary 
        shall, in making awards under this section, ensure that 
        with respect to the cooperative agreement awarded, the 
        entity make available appropriate portions of such 
        award to political subdivisions and local departments 
        of public health through a process involving the 
        consensus, approval or concurrence with such local 
        entities.
    (j) Administrative and Fiscal Responsibility.--
            (1) Annual reporting requirements.--Each entity 
        shall prepare and submit to the Secretary annual 
        reports on its activities under this section and 
        section 319C-2. Each such report shall be prepared by, 
        or in consultation with, the health department. In 
        order to properly evaluate and compare the performance 
        of different entities assisted under this section and 
        section 319C-2 and to assure the proper expenditure of 
        funds under this section and section 319C-2, such 
        reports shall be in such standardized form and contain 
        such information as the Secretary determines and 
        describes within 180 days of the date of enactment of 
        the Pandemic and All-Hazards Preparedness Act (after 
        consultation with the States) to be necessary to--
                    (A) secure an accurate description of those 
                activities;
                    (B) secure a complete record of the 
                purposes for which funds were spent, and of the 
                recipients of such funds;
                    (C) describe the extent to which the entity 
                has met the goals and objectives it set forth 
                under this section or section 319C-2;
                    (D) determine the extent to which funds 
                were expended consistent with the entity's 
                application transmitted under this section or 
                section 319C-2; and
                    (E) publish such information on a Federal 
                Internet website consistent with subsection 
                (k).
            (2) Audits; implementation.--
                    (A) In general.--Each entity receiving 
                funds under this section or section 319C-2 
                shall, not less often than once every 2 years, 
                audit its expenditures from amounts received 
                under this section or section 319C-2. Such 
                audits shall be conducted by an entity 
                independent of the agency administering a 
                program funded under this section or section 
                319C-2 in accordance with the Comptroller 
                General's standards for auditing governmental 
                organizations, programs, activities, and 
                functions and generally accepted auditing 
                standards. Within 30 days following the 
                completion of each audit report, the entity 
                shall submit a copy of that audit report to the 
                Secretary.
                    (B) Repayment.--Each entity shall repay to 
                the United States amounts found by the 
                Secretary, after notice and opportunity for a 
                hearing to the entity, not to have been 
                expended in accordance with this section or 
                section 319C-2 and, if such repayment is not 
                made, the Secretary may offset such amounts 
                against the amount of any allotment to which 
                the entity is or may become entitled under this 
                section or section 319C-2 or may otherwise 
                recover such amounts.
                    (C) Withholding of payment.--The Secretary 
                may, after notice and opportunity for a 
                hearing, withhold payment of funds to any 
                entity which is not using its allotment under 
                this section or section 319C-2 in accordance 
                with such section. The Secretary may withhold 
                such funds until the Secretary finds that the 
                reason for the withholding has been removed and 
                there is reasonable assurance that it will not 
                recur.
            (3) Maximum carryover amount.--
                    (A) In general.--For each fiscal year, the 
                Secretary, in consultation with the States and 
                political subdivisions, shall determine the 
                maximum percentage amount of an award under 
                this section that an entity may carryover to 
                the succeeding fiscal year.
                    (B) Amount exceeded.--For each fiscal year, 
                if the percentage amount of an award under this 
                section unexpended by an entity exceeds the 
                maximum percentage permitted by the Secretary 
                under subparagraph (A), the entity shall return 
                to the Secretary the portion of the unexpended 
                amount that exceeds the maximum amount 
                permitted to be carried over by the Secretary.
                    (C) Action by secretary.--The Secretary 
                shall make amounts returned to the Secretary 
                under subparagraph (B) available for awards 
                under section 319C-2(b)(1). In making awards 
                under section 319C-2(b)(1) with amounts 
                collected under this paragraph the Secretary 
                shall give preference to entities that are 
                located in whole or in part in States from 
                which amounts have been returned under 
                subparagraph (B).
                    (D) Waiver.--An entity may apply to the 
                Secretary for a waiver of the maximum 
                percentage amount under subparagraph (A). Such 
                an application for a waiver shall include an 
                explanation why such requirement should not 
                apply to the entity and the steps taken by such 
                entity to ensure that all funds under an award 
                under this section will be expended 
                appropriately.
                    (E) Waive or reduce withholding.--The 
                Secretary may waive the application of 
                subparagraph (B), or reduce the amount 
                determined under such subparagraph, for a 
                single entity pursuant to subparagraph (D) or 
                for all entities in a fiscal year, if the 
                Secretary determines that mitigating conditions 
                exist that justify the waiver or reduction.
    (k) Compilation and Availability of Data.--The Secretary 
shall compile the data submitted under this section and make 
such data available in a timely manner on an appropriate 
Internet website in a format that is useful to the public and 
to other entities and that provides information on what 
activities are best contributing to the achievement of the 
outcome goals described in subsection (g).

SEC. 319C-2. [247D-3B] PARTNERSHIPS FOR STATE AND REGIONAL HOSPITAL 
                    PREPAREDNESS TO IMPROVE SURGE CAPACITY.

    (a) In General.--The Secretary shall award competitive 
grants or cooperative agreements to eligible entities to enable 
such entities to improve surge capacity and enhance community 
and hospital preparedness for public health emergencies.
    (b) Eligibility.--To be eligible for an award under 
subsection (a), an entity shall--
            (1)(A) be a partnership consisting of--
                    (i) one or more hospitals, at least one of 
                which shall be a designated trauma center, 
                consistent with section 1213(c);
                    (ii) one or more other local health care 
                facilities, including clinics, health centers, 
                primary care facilities, mental health centers, 
                mobile medical assets, or nursing homes; and
                    (iii)(I) one or more political 
                subdivisions;
                    (II) one or more States; or
                    (III) one or more States and one or more 
                political subdivisions; and
            (B) prepare, in consultation with the Chief 
        Executive Officer and the lead health officials of the 
        State, District, or territory in which the hospital and 
        health care facilities described in subparagraph (A) 
        are located, and submit to the Secretary, an 
        application at such time, in such manner, and 
        containing such information as the Secretary may 
        require; or
            (2)(A) be an entity described in section 319C-
        1(b)(1); and
            (B) submit an application at such time, in such 
        manner, and containing such information as the 
        Secretary may require, including the information or 
        assurances required under section 319C-1(b)(2) and an 
        assurance that the State will adhere to any applicable 
        guidelines established by the Secretary.
    (c) Use of Funds.--An award under subsection (a) shall be 
expended for activities to achieve the preparedness goals 
described under paragraphs (1), (3), (4), (5), and (6) of 
section 2802(b).
    (d) Preferences.--
            (1) Regional coordination.--In making awards under 
        subsection (a), the Secretary shall give preference to 
        eligible entities that submit applications that, in the 
        determination of the Secretary--
                    (A) will enhance coordination--
                            (i) among the entities described in 
                        subsection (b)(1)(A)(i); and
                            (ii) between such entities and the 
                        entities described in subsection 
                        (b)(1)(A)(ii); and
                    (B) include, in the partnership described 
                in subsection (b)(1)(A), a significant 
                percentage of the hospitals and health care 
                facilities within the geographic area served by 
                such partnership.
            (2) Other preferences.--In making awards under 
        subsection (a), the Secretary shall give preference to 
        eligible entities that, in the determination of the 
        Secretary--
                    (A) include one or more hospitals that are 
                participants in the National Disaster Medical 
                System;
                    (B) are located in a geographic area that 
                faces a high degree of risk, as determined by 
                the Secretary in consultation with the 
                Secretary of Homeland Security; or
                    (C) have a significant need for funds to 
                achieve the medical preparedness goals 
                described in section 2802(b)(3).
    (e) Consistency of Planned Activities.--The Secretary may 
not award a cooperative agreement to an eligible entity 
described in subsection (b)(1) unless the application submitted 
by the entity is coordinated and consistent with an applicable 
State All-Hazards Public Health Emergency Preparedness and 
Response Plan and relevant local plans, as determined by the 
Secretary in consultation with relevant State health officials.
    (f) Limitation on Awards.--A political subdivision shall 
not participate in more than one partnership described in 
subsection (b)(1).
    (g) Coordination With Local Response Capabilities.--An 
eligible entity shall, to the extent practicable, ensure that 
activities carried out under an award under subsection (a) are 
coordinated with activities of relevant local Metropolitan 
Medical Response Systems, local Medical Reserve Corps, the 
Cities Readiness Initiative, and local emergency plans.
    (h) Maintenance of Funding.--
            (1) In general.--An entity that receives an award 
        under this section shall maintain expenditures for 
        health care preparedness at a level that is not less 
        than the average level of such expenditures maintained 
        by the entity for the preceding 2 year period.
            (2) Rule of construction.--Nothing in this section 
        shall be construed to prohibit the use of awards under 
        this section to pay salary and related expenses of 
        public health and other professionals employed by 
        State, local, or tribal agencies who are carrying out 
        activities supported by such awards (regardless of 
        whether the primary assignment of such personnel is to 
        carry out such activities).
    (i) Performance and Accountability.--The requirements of 
section 319C-1(g), (j), and (k) shall apply to entities 
receiving awards under this section (regardless of whether such 
entities are described under subsection (b)(1)(A) or (b)(2)(A)) 
in the same manner as such requirements apply to entities under 
section 319C-1. An entity described in subsection (b)(1)(A) 
shall make such reports available to the lead health official 
of the State in which such partnership is located.
    (j) Authorization of Appropriations.--
            (1) In general.--For the purpose of carrying out 
        this section, there is authorized to be appropriated 
        $474,000,000 for fiscal year 2007, and such sums as may 
        be necessary for each of fiscal years 2008 through 
        2011.
            (2) Reservation of amounts for partnerships.--Prior 
        to making awards described in paragraph (3), the 
        Secretary may reserve from the amount appropriated 
        under paragraph (1) for a fiscal year, an amount 
        determined appropriate by the Secretary for making 
        awards to entities described in subsection (b)(1)(A).
            (3) Awards to states and political subdivisions.--
                    (A) In general.--From amounts appropriated 
                for a fiscal year under paragraph (1) and not 
                reserved under paragraph (2), the Secretary 
                shall make awards to entities described in 
                subsection (b)(2)(A) that have completed an 
                application as described in subsection 
                (b)(2)(B).
                    (B) Amount.--The Secretary shall determine 
                the amount of an award to each entity described 
                in subparagraph (A) in the same manner as such 
                amounts are determined under section 319C-1(i).

SEC. 319D. [247D-4] REVITALIZING THE CENTERS FOR DISEASE CONTROL AND 
                    PREVENTION.

    (a) Facilities; Capacities.--
            (1) Findings.--Congress finds that the Centers for 
        Disease Control and Prevention has an essential role in 
        defending against and combatting public health threats 
        domestically and abroad and requires secure and modern 
        facilities, and expanded and improved capabilities 
        related to bioterrorism and other public health 
        emergencies, sufficient to enable such Centers to 
        conduct this important mission.
            (2) Facilities.--
                    (A) In general.--The Director of the 
                Centers for Disease Control and Prevention may 
                design, construct, and equip new facilities, 
                renovate existing facilities (including 
                laboratories, laboratory support buildings, 
                scientific communication facilities, 
                transshipment complexes, secured and isolated 
                parking structures, office buildings, and other 
                facilities and infrastructure), and upgrade 
                security of such facilities, in order to better 
                conduct the capacities described in section 
                319A, and for supporting public health 
                activities.
                    (B) Multiyear contracting authority.--For 
                any project of designing, constructing, 
                equipping, or renovating any facility under 
                subparagraph (A), the Director of the Centers 
                for Disease Control and Prevention may enter 
                into a single contract or related contracts 
                that collectively include the full scope of the 
                project, and the solicitation and contract 
                shall contain the clause ``availability of 
                funds'' found at section 52.232-18 of title 48, 
                Code of Federal Regulations.
            (3) Improving the capacities of the centers for 
        disease control and prevention.--The Secretary shall 
        expand, enhance, and improve the capabilities of the 
        Centers for Disease Control and Prevention relating to 
        preparedness for and responding effectively to 
        bioterrorism and other public health emergencies. 
        Activities that may be carried out under the preceding 
        sentence include--
                    (A) expanding or enhancing the training of 
                personnel;
                    (B) improving communications facilities and 
                networks, including delivery of necessary 
                information to rural areas;
                    (C) improving capabilities for public 
                health surveillance and reporting activities, 
                taking into account the integrated system or 
                systems of public health alert communications 
                and surveillance networks under subsection (b); 
                and
                    (D) improving laboratory facilities related 
                to bioterrorism and other public health 
                emergencies, including increasing the security 
                of such facilities.
    (b) National Communications and Surveillance Networks.--
            (1) In general.--The Secretary, directly or through 
        awards of grants, contracts, or cooperative agreements, 
        shall provide for the establishment of an integrated 
        system or systems of public health alert communications 
        and surveillance networks between and among--
                    (A) Federal, State, and local public health 
                officials;
                    (B) public and private health-related 
                laboratories, hospitals, and other health care 
                facilities; and
                    (C) any other entities determined 
                appropriate by the Secretary.
            (2) Requirements.--The Secretary shall ensure that 
        networks under paragraph (1) allow for the timely 
        sharing and discussion, in a secure manner, of 
        essential information concerning bioterrorism or 
        another public health emergency, or recommended methods 
        for responding to such an attack or emergency.
            (3) Standards.--Not later than one year after the 
        date of the enactment of the Public Health Security and 
        Bioterrorism Preparedness and Response Act of 2002, the 
        Secretary, in cooperation with health care providers 
        and State and local public health officials, shall 
        establish any additional technical and reporting 
        standards (including standards for interoperability) 
        for networks under paragraph (1).
    (c) Authorization of Appropriations.--
            (1) Facilities; capacities.--
                    (A) Facilities.--For the purpose of 
                carrying out subsection (a)(2), there are 
                authorized to be appropriated $300,000,000 for 
                each of the fiscal years 2002 and 2003, and 
                such sums as may be necessary for each of the 
                fiscal years 2004 through 2006.
                    (B) Mission; Improving capacities.--For the 
                purposes of achieving the mission of the 
                Centers for Disease Control and Prevention 
                described in subsection (a)(1), for carrying 
                out subsection (a)(3), for better conducting 
                the capacities described in section 319A, and 
                for supporting public health activities, there 
                are authorized to be appropriated such sums as 
                may be necessary for each of the fiscal years 
                2002 through 2006.
            (2) National communications and surveillance 
        networks.--For the purpose of carrying out subsection 
        (b), there are authorized to be appropriated such sums 
        as may be necessary for each of the fiscal years 2002 
        through 2006.
    (d) Public Health Situational Awareness.--
            (1) In general.--Not later than 2 years after the 
        date of enactment of the Pandemic and All-Hazards 
        Preparedness Act, the Secretary, in collaboration with 
        State, local, and tribal public health officials, shall 
        establish a near real-time electronic nationwide public 
        health situational awareness capability through an 
        interoperable network of systems to share data and 
        information to enhance early detection of rapid 
        response to, and management of, potentially 
        catastrophic infectious disease outbreaks and other 
        public health emergencies that originate domestically 
        or abroad. Such network shall be built on existing 
        State situational awareness systems or enhanced systems 
        that enable such connectivity.
            (2) Strategic plan.--Not later than 180 days after 
        the date of enactment the Pandemic and All-Hazards 
        Preparedness Act, the Secretary shall submit to the 
        appropriate committees of Congress, a strategic plan 
        that demonstrates the steps the Secretary will 
        undertake to develop, implement, and evaluate the 
        network described in paragraph (1), utilizing the 
        elements described in paragraph (3).
            (3) Elements.--The network described in paragraph 
        (1) shall include data and information transmitted in a 
        standardized format from--
                    (A) State, local, and tribal public health 
                entities, including public health laboratories;
                    (B) Federal health agencies;
                    (C) zoonotic disease monitoring systems;
                    (D) public and private sector health care 
                entities, hospitals, pharmacies, poison control 
                centers or professional organizations in the 
                field of poison control, and clinical 
                laboratories, to the extent practicable and 
                provided that such data are voluntarily 
                provided simultaneously to the Secretary and 
                appropriate State, local, and tribal public 
                health agencies; and
                    (E) such other sources as the Secretary may 
                deem appropriate.
            (4) Rule of construction.--Paragraph (3) shall not 
        be construed as requiring separate reporting of data 
        and information from each source listed.
            (5) Required activities.--In establishing and 
        operating the network described in paragraph (1), the 
        Secretary shall--
                    (A) utilize applicable interoperability 
                standards as determined by the Secretary 
                through a joint public and private sector 
                process;
                    (B) define minimal data elements for such 
                network;
                    (C) in collaboration with State, local, and 
                tribal public health officials, integrate and 
                build upon existing State, local, and tribal 
                capabilities, ensuring simultaneous sharing of 
                data, information, and analyses from the 
                network described in paragraph (1) with State, 
                local, and tribal public health agencies; and
                    (D) in collaboration with State, local, and 
                tribal public health officials, develop 
                procedures and standards for the collection, 
                analysis, and interpretation of data that 
                States, regions, or other entities collect and 
                report to the network described in paragraph 
                (1).
    (e) State and Regional Systems To Enhance Situational 
Awareness in Public Health Emergencies.--
            (1) In general.--To implement the network described 
        in subsection (d), the Secretary may award grants to 
        States or consortia of States to enhance the ability of 
        such States or consortia of States to establish or 
        operate a coordinated public health situational 
        awareness system for regional or Statewide early 
        detection of, rapid response to, and management of 
        potentially catastrophic infectious disease outbreaks 
        and public health emergencies, in collaboration with 
        appropriate public health agencies, sentinel hospitals, 
        clinical laboratories, pharmacies, poison control 
        centers, other health care organizations, and animal 
        health organizations within such States.
            (2) Eligibility.--To be eligible to receive a grant 
        under paragraph (1), the State or consortium of States 
        shall submit to the Secretary an application at such 
        time, in such manner, and containing such information 
        as the Secretary may require, including an assurance 
        that the State or consortium of States will submit to 
        the Secretary--
                    (A) reports of such data, information, and 
                metrics as the Secretary may require;
                    (B) a report on the effectiveness of the 
                systems funded under the grant; and
                    (C) a description of the manner in which 
                grant funds will be used to enhance the 
                timelines and comprehensiveness of efforts to 
                detect, respond to, and manage potentially 
                catastrophic infectious disease outbreaks and 
                public health emergencies.
            (3) Use of funds.--A State or consortium of States 
        that receives an award under this subsection--
                    (A) shall establish, enhance, or operate a 
                coordinated public health situational awareness 
                system for regional or Statewide early 
                detection of, rapid response to, and management 
                of potentially catastrophic infectious disease 
                outbreaks and public health emergencies;
                    (B) may award grants or contracts to 
                entities described in paragraph (1) within or 
                serving such State to assist such entities in 
                improving the operation of information 
                technology systems, facilitating the secure 
                exchange of data and information, and training 
                personnel to enhance the operation of the 
                system described in subparagraph (A); and
                    (C) may conduct a pilot program for the 
                development of multi-State telehealth network 
                test beds that build on, enhance, and securely 
                link existing State and local telehealth 
                programs to prepare for, monitor, respond to, 
                and manage the events of public health 
                emergencies, facilitate coordination and 
                communication among medical, public health, and 
                emergency response agencies, and provide 
                medical services through telehealth initiatives 
                within the States that are involved in such a 
                multi-State telehealth network test bed.
            (4) Limitation.--Information technology systems 
        acquired or implemented using grants awarded under this 
        section must be compliant with--
                    (A) interoperability and other 
                technological standards, as determined by the 
                Secretary; and
                    (B) data collection and reporting 
                requirements for the network described in 
                subsection (d).
            (5) Independent evaluation.--Not later than 4 years 
        after the date of enactment of the Pandemic and All-
        Hazards Preparedness Act, the Government Accountability 
        Office shall conduct an independent evaluation, and 
        submit to the Secretary and the appropriate committees 
        of Congress a report concerning the activities 
        conducted under this subsection and subsection (d).
    (f) Telehealth Enhancements for Emergency Response.--
            (1) Evaluation.--The Secretary, in consultation 
        with the Federal Communications Commission and other 
        relevant Federal agencies, shall--
                    (A) conduct an inventory of telehealth 
                initiatives in existence on the date of 
                enactment of the Pandemic and All-Hazards 
                Preparedness Act, including--
                            (i) the specific location of 
                        network components;
                            (ii) the medical, technological, 
                        and communications capabilities of such 
                        components;
                            (iii) the functionality of such 
                        components; and
                            (iv) the capacity and ability of 
                        such components to handle increased 
                        volume during the response to a public 
                        health emergency;
                    (B) identify methods to expand and 
                interconnect the regional health information 
                networks funded by the Secretary, the State and 
                regional broadband networks funded through the 
                rural health care support mechanism pilot 
                program funded by the Federal Communications 
                Commission, and other telehealth networks;
                    (C) evaluate ways to prepare for, monitor, 
                respond rapidly to, or manage the events of, a 
                public health emergency through the enhanced 
                use of telehealth technologies, including 
                mechanisms for payment or reimbursement for use 
                of such technologies and personnel during 
                public health emergencies;
                    (D) identify methods for reducing legal 
                barriers that deter health care professionals 
                from providing telemedicine services, such as 
                by utilizing State emergency health care 
                professional credentialing verification 
                systems, encouraging States to establish and 
                implement mechanisms to improve interstate 
                medical licensure cooperation, facilitating the 
                exchange of information among States regarding 
                investigations and adverse actions, and 
                encouraging States to waive the application of 
                licensing requirements during a public health 
                emergency;
                    (E) evaluate ways to integrate the practice 
                of telemedicine within the National Disaster 
                Medical System; and
                    (F) promote greater coordination among 
                existing Federal interagency telemedicine and 
                health information technology initiatives.
            (2) Report.--Not later than 12 months after the 
        date of enactment of the Pandemic and All-Hazards 
        Preparedness Act, the Secretary shall prepare and 
        submit a report to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on 
        Energy and Commerce of the House of Representatives 
        regarding the findings and recommendations pursuant to 
        subparagraphs (A) through (F) of paragraph (1).
    (g) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section, such sums as may 
be necessary in each of fiscal years 2007 through 2011.

SEC. 319E. [247D-5] COMBATING ANTIMICROBIAL RESISTANCE.

    (a) Task Force.--
            (1) In general.--The Secretary shall establish an 
        Antimicrobial Resistance Task Force to provide advice 
        and recommendations to the Secretary and coordinate 
        Federal programs relating to antimicrobial resistance. 
        The Secretary may appoint or select a committee, or 
        other organization in existence as of the date of the 
        enactment of this section, to serve as such a task 
        force, if such committee, or other organization meets 
        the requirements of this section.
            (2) Members of task force.--The task force 
        described in paragraph (1) shall be composed of 
        representatives from such Federal agencies, and shall 
        seek input from public health constituencies, 
        manufacturers, veterinary and medical professional 
        societies and others, as determined to be necessary by 
        the Secretary, to develop and implement a comprehensive 
        plan to address the public health threat of 
        antimicrobial resistance.
            (3) Agenda.--
                    (A) In general.--The task force described 
                in paragraph (1) shall consider factors the 
                Secretary considers appropriate, including--
                            (i) public health factors 
                        contributing to increasing 
                        antimicrobial resistance;
                            (ii) public health needs to detect 
                        and monitor antimicrobial resistance;
                            (iii) detection, prevention, and 
                        control strategies for resistant 
                        pathogens;
                            (iv) the need for improved 
                        information and data collection;
                            (v) the assessment of the risk 
                        imposed by pathogens presenting a 
                        threat to the public health; and
                            (vi) any other issues which the 
                        Secretary determines are relevant to 
                        antimicrobial resistance.
                    (B) Detection and control.--The Secretary, 
                in consultation with the task force described 
                in paragraph (1) and State and local public 
                health officials, shall--
                            (i) develop, improve, coordinate or 
                        enhance participation in a surveillance 
                        plan to detect and monitor emerging 
                        antimicrobial resistance; and
                            (ii) develop, improve, coordinate 
                        or enhance participation in an 
                        integrated information system to 
                        assimilate, analyze, and exchange 
                        antimicrobial resistance data between 
                        public health departments.
            (4) Meetings.--The task force described under 
        paragraph (1) shall convene not less than twice a year, 
        or more frequently as the Secretary determines to be 
        appropriate.
    (b) Research and Development of New Antimicrobial Drugs and 
Diagnostics.--The Secretary and the Director of Agricultural 
Research Services, consistent with the recommendations of the 
task force established under subsection (a), shall directly or 
through awards of grants or cooperative agreements to public or 
private entities provide for the conduct of research, 
investigations, experiments, demonstrations, and studies in the 
health sciences that are related to--
            (1) the development of new therapeutics, including 
        vaccines and antimicrobials, against resistant 
        pathogens;
            (2) the development or testing of medical 
        diagnostics to detect pathogens resistant to 
        antimicrobials;
            (3) the epidemiology, mechanisms, and pathogenesis 
        of antimicrobial resistance;
            (4) the sequencing of the genomes, or other DNA 
        analysis, or other comparative analysis, of priority 
        pathogens (as determined by the Director of the 
        National Institutes of Health in consultation with the 
        task force established under subsection (a)), in 
        collaboration and coordination with the activities of 
        the Department of Defense and the Joint Genome 
        Institute of the Department of Energy; and
            (5) other relevant research areas.
    (c) Education of Medical and Public Health Personnel.--The 
Secretary, after consultation with the Assistant Secretary for 
Health, the Surgeon General, the Director of the Centers for 
Disease Control and Prevention, the Administrator of the Health 
Resources and Services Administration, the Director of the 
Agency for Healthcare Research and Quality, members of the task 
force described in subsection (a), professional organizations 
and societies, and such other public health officials as may be 
necessary, shall--
            (1) develop and implement educational programs to 
        increase the awareness of the general public with 
        respect to the public health threat of antimicrobial 
        resistance and the appropriate use of antibiotics;
            (2) develop and implement educational programs to 
        instruct health care professionals in the prudent use 
        of antibiotics; and
            (3) develop and implement programs to train 
        laboratory personnel in the recognition or 
        identification of resistance in pathogens.
    (d) Grants.--
            (1) In general.--The Secretary shall award 
        competitive grants to eligible entities to enable such 
        entities to increase the capacity to detect, monitor, 
        and combat antimicrobial resistance.
            (2) Eligible entities.--Eligible entities for 
        grants under paragraph (1) shall be State or local 
        public health agencies, Indian tribes or tribal 
        organizations, or other public or private nonprofit 
        entities.
            (3) Use of funds.--An eligible entity receiving a 
        grant under paragraph (1) shall use funds from such 
        grant for activities that are consistent with the 
        factors identified by the task force under subsection 
        (a)(3), which may include activities that--
                    (A) provide training to enable such entity 
                to identify patterns of resistance rapidly and 
                accurately;
                    (B) develop, improve, coordinate or enhance 
                participation in information systems by which 
                data on resistant infections can be shared 
                rapidly among relevant national, State, and 
                local health agencies and health care 
                providers; and
                    (C) develop and implement policies to 
                control the spread of antimicrobial resistance.
    (e) Grants for Demonstration Programs.--
            (1) In general.--The Secretary shall award 
        competitive grants to eligible entities to establish 
        demonstration programs to promote judicious use of 
        antimicrobial drugs or control the spread of 
        antimicrobial-resistant pathogens.
            (2) Eligible entities.--Eligible entities for 
        grants under paragraph (1) may include hospitals, 
        clinics, institutions of long-term care, professional 
        medical societies, schools or programs that train 
        medical laboratory personnel, or other public or 
        private nonprofit entities.
            (3) Technical assistance.--The Secretary shall 
        provide appropriate technical assistance to eligible 
        entities that receive grants under paragraph (1).
    (f ) Supplement Not Supplant.--Funds appropriated under 
this section shall be used to supplement and not supplant other 
Federal, State, and local public funds provided for activities 
under this section.
    (g) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section, $40,000,000 for 
fiscal year 2001, $25,000,000 for each of the fiscal years 2002 
and 2003, and such sums as may be necessary for each of the 
fiscal years 2004 through 2006.

SEC. 319F. [247D-6] PUBLIC HEALTH COUNTERMEASURES TO A BIOTERRORIST 
                    ATTACK.

    (a) All-Hazards Public Health and Medical Response 
Curricula and Training.--
            (1) In general.--The Secretary, in collaboration 
        with the Secretary of Defense, and in consultation with 
        relevant public and private entities, shall develop 
        core health and medical response curricula and 
        trainings by adapting applicable existing curricula and 
        training programs to improve responses to public health 
        emergencies.
            (2) Curriculum.--The public health and medical 
        response training program may include course work 
        related to--
                    (A) medical management of casualties, 
                taking into account the needs of at-risk 
                individuals;
                    (B) public health aspects of public health 
                emergencies;
                    (C) mental health aspects of public health 
                emergencies;
                    (D) national incident management, including 
                coordination among Federal, State, local, 
                tribal, international agencies, and other 
                entities; and
                    (E) protecting health care workers and 
                health care first responders from workplace 
                exposures during a public health emergency.
            (3) Peer review.--On a periodic basis, products 
        prepared as part of the program shall be rigorously 
        tested and peer-reviewed by experts in the relevant 
        fields.
            (4) Credit.--The Secretary and the Secretary of 
        Defense shall--
                    (A) take into account continuing 
                professional education requirements of public 
                health and healthcare professions; and
                    (B) cooperate with State, local, and tribal 
                accrediting agencies and with professional 
                associations in arranging for students enrolled 
                in the program to obtain continuing 
                professional education credit for program 
                courses.
            (5) Dissemination and training.--
                    (A) In general.--The Secretary may provide 
                for the dissemination and teaching of the 
                materials described in paragraphs (1) and (2) 
                by appropriate means, as determined by the 
                Secretary.
                    (B) Certain entities.--The education and 
                training activities described in subparagraph 
                (A) may be carried out by Federal public health 
                or medical entities, appropriate educational 
                entities, professional organizations and 
                societies, private accrediting organizations, 
                and other nonprofit institutions or entities 
                meeting criteria established by the Secretary.
                    (C) Grants and contracts.--In carrying out 
                this subsection, the Secretary may carry out 
                activities directly or through the award of 
                grants and contracts, and may enter into 
                interagency agreements with other Federal 
                agencies.
    (b) Advice to the Federal Government.--
            (1) Required advisory committees.--In coordination 
        with the working group under subsection (a), the 
        Secretary shall establish advisory committees in 
        accordance with paragraphs (2) and (3) to provide 
        expert recommendations to assist such working groups in 
        carrying out their respective responsibilities under 
        subsections (a) and (b) \1\.
---------------------------------------------------------------------------
    \1\ Probably should be ``to assist such working group in carrying 
out its responsibilities under subsection (a)''. Formerly there were 
two working groups, one under subsection (a) and one under subsection 
(b). Now there is only the working group under subsection (a). See the 
amendments made by sections 104(a) and 108 of Public Law 107-188 (116 
Stat. 605, 609).
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            (2) National advisory committee on children and 
        terrorism \2\.--
---------------------------------------------------------------------------
    \2\ The heading for subsection (b)(2) probably should read 
``National advisory committee on at-risk individuals and public health 
emergencies''. The amendment made by section 301(d)(1) of Public Law 
109-417 (120 Stat. 2854) to strike ``Children and terrorism'' and 
insert ``At-risk individuals and public health emergencies'' could not 
be executed due to incorrect capitalization of the word ``Children'' in 
the matter to be struck. Also the letter ``A'' in the word ``At-risk'' 
in the inserted text probably should be lowercase type.
---------------------------------------------------------------------------
                    (A) In general.--For purposes of paragraph 
                (1), the Secretary shall establish an advisory 
                committee to be known as the National Advisory 
                Committee on At-Risk Individuals and Public 
                Health Emergencies (referred to in this 
                paragraph as the ``Advisory Committee'').
                    (B) Duties.--The Advisory Committee shall 
                provide recommendations regarding--
                            (i) the preparedness of the health 
                        care (including mental health care) 
                        system to respond to public health 
                        emergencies as they relate to at-risk 
                        individuals;
                            (ii) needed changes to the health 
                        care and emergency medical service 
                        systems and emergency medical services 
                        protocols to meet the special needs of 
                        at-risk individuals; and
                            (iii) changes, if necessary, to the 
                        national stockpile under section 121 of 
                        the Public Health Security and 
                        Bioterrorism Preparedness and Response 
                        Act of 2002 to meet the emergency 
                        health security of at-risk individuals.
                    (C) Composition.--The Advisory Committee 
                shall be composed of such Federal officials as 
                may be appropriate to address the special needs 
                of the diverse population groups of at-risk 
                populations.
                    (D) Termination.--The Advisory Committee 
                terminates six years after the date of the 
                enactment of the Public Health Security and 
                Bioterrorism Preparedness and Response Act of 
                2002.
            (3) Emergency public information and communications 
        advisory committee.--
                    (A) In general.--For purposes of paragraph 
                (1), the Secretary shall establish an advisory 
                committee to be known as the Emergency Public 
                Information and Communications Advisory 
                Committee (referred to in this paragraph as the 
                ``EPIC Advisory Committee'').
                    (B) Duties.--The EPIC Advisory Committee 
                shall make recommendations to the Secretary and 
                report on appropriate ways to communicate 
                public health information regarding 
                bioterrorism and other public health 
                emergencies to the public.
                    (C) Composition.--The EPIC Advisory 
                Committee shall be composed of individuals 
                representing a diverse group of experts in 
                public health, medicine, communications, 
                behavioral psychology, and other areas 
                determined appropriate by the Secretary.
                    (D) Dissemination.--The Secretary shall 
                review the recommendations of the EPIC Advisory 
                Committee and ensure that appropriate 
                information is disseminated to the public.
                    (E) Termination.--The EPIC Advisory 
                Committee terminates one year after the date of 
                the enactment of Public Health Security and 
                Bioterrorism Preparedness and Response Act of 
                2002.
    (c) Expansion of Epidemic Intelligence Service Program.--
The Secretary may establish 20 officer positions in the 
Epidemic Intelligence Service Program, in addition to the 
number of the officer positions offered under such Program in 
2006, for individuals who agree to participate, for a period of 
not less than 2 years, in the Career Epidemiology Field Officer 
program in a State, local, or tribal health department that 
serves a health professional shortage area (as defined under 
section 332(a)), a medically underserved population (as defined 
under section 330(b)(3)), or a medically underserved area or 
area at high risk of a public health emergency as designated by 
the Secretary.
    (d) Centers for Public Health Preparedness; Core Curricula 
and Training.--
            (1) In general.--The Secretary may establish at 
        accredited schools of public health, Centers for Public 
        Health Preparedness (hereafter referred to in this 
        section as the ``Centers'').
            (2) Eligibility.--To be eligible to receive an 
        award under this subsection to establish a Center, an 
        accredited school of public health shall agree to 
        conduct activities consistent with the requirements of 
        this subsection.
            (3) Core curricula.--The Secretary, in 
        collaboration with the Centers and other public or 
        private entities shall establish core curricula based 
        on established competencies leading to a 4-year 
        bachelor's degree, a graduate degree, a combined 
        bachelor and master's degree, or a certificate program, 
        for use by each Center. The Secretary shall disseminate 
        such curricula to other accredited schools of public 
        health and other health professions schools determined 
        appropriate by the Secretary, for voluntary use by such 
        schools.
            (4) Core competency-based training program.--The 
        Secretary, in collaboration with the Centers and other 
        public or private entities shall facilitate the 
        development of a competency-based training program to 
        train public health practitioners. The Centers shall 
        use such training program to train public health 
        practitioners. The Secretary shall disseminate such 
        training program to other accredited schools of public 
        health, health professions schools, and other public or 
        private entities as determined by the Secretary, for 
        voluntary use by such entities.
            (5) Content of core curricula and training 
        program.--The Secretary shall ensure that the core 
        curricula and training program established pursuant to 
        this subsection respond to the needs of State, local, 
        and tribal public health authorities and integrate and 
        emphasize essential public health security capabilities 
        consistent with section 2802(b)(2).
            (6) Academic-workforce communication.--As a 
        condition of receiving funding from the Secretary under 
        this subsection, a Center shall collaborate with a 
        State, local, or tribal public health department to--
                    (A) define the public health preparedness 
                and response needs of the community involved;
                    (B) assess the extent to which such needs 
                are fulfilled by existing preparedness and 
                response activities of such school or health 
                department, and how such activities may be 
                improved;
                    (C) prior to developing new materials or 
                trainings, evaluate and utilize relevant 
                materials and trainings developed by others 
                Centers; and
                    (D) evaluate community impact and the 
                effectiveness of any newly developed materials 
                or trainings.
            (7) Public health systems research.--In 
        consultation with relevant public and private entities, 
        the Secretary shall define the existing knowledge base 
        for public health preparedness and response systems, 
        and establish a research agenda based on Federal, 
        State, local, and tribal public health preparedness 
        priorities. As a condition of receiving funding from 
        the Secretary under this subsection, a Center shall 
        conduct public health systems research that is 
        consistent with the agenda described under this 
        paragraph.
    (e) Accelerated Research and Development on Priority 
Pathogens and Countermeasures.--
            (1) In general.--With respect to pathogens of 
        potential use in a bioterrorist attack, and other 
        agents that may cause a public health emergency, the 
        Secretary, taking into consideration any 
        recommendations of the working group under subsection 
        (a), shall conduct, and award grants, contracts, or 
        cooperative agreements for, research, investigations, 
        experiments, demonstrations, and studies in the health 
        sciences relating to--
                    (A) the epidemiology and pathogenesis of 
                such pathogens;
                    (B) the sequencing of the genomes, or other 
                DNA analysis, or other comparative analysis, of 
                priority pathogens (as determined by the 
                Director of the National Institutes of Health 
                in consultation with the working group 
                established in subsection (a)), in 
                collaboration and coordination with the 
                activities of the Department of Defense and the 
                Joint Genome Institute of the Department of 
                Energy;
                    (C) the development of priority 
                countermeasures; and
                    (D) other relevant areas of research;
        with consideration given to the needs of children and 
        other vulnerable populations.
            (2) Priority.--The Secretary shall give priority 
        under this section to the funding of research and other 
        studies related to priority countermeasures.
            (3) Role of department of veterans affairs.--In 
        carrying out paragraph (1), the Secretary shall 
        consider using the biomedical research and development 
        capabilities of the Department of Veterans Affairs, in 
        conjunction with that Department's affiliations with 
        health-professions universities. When advantageous to 
        the Government in furtherance of the purposes of such 
        paragraph, the Secretary may enter into cooperative 
        agreements with the Secretary of Veterans Affairs to 
        achieve such purposes.
            (4) Priority countermeasures.--For purposes of this 
        section, the term ``priority countermeasure'' means a 
        drug, biological product, device, vaccine, vaccine 
        adjuvant, antiviral, or diagnostic test that the 
        Secretary determines to be--
                    (A) a priority to treat, identify, or 
                prevent infection by a biological agent or 
                toxin listed pursuant to section 351A(a)(1), or 
                harm from any other agent that may cause a 
                public health emergency; or
                    (B) a priority to treat, identify, or 
                prevent conditions that may result in adverse 
                health consequences or death and may be caused 
                by the administering of a drug, biological 
                product, device, vaccine, vaccine adjuvant, 
                antiviral, or diagnostic test that is a 
                priority under subparagraph (A).
    (f) Authorization of Appropriations.--
            (1) Fiscal year 2007.--There are authorized to be 
        appropriated to carry out this section for fiscal year 
        2007--
                    (A) to carry out subsection (a)--
                            (i) $5,000,000 to carry out 
                        paragraphs (1) through (4); and
                            (ii) $7,000,000 to carry out 
                        paragraph (5);
                    (B) to carry out subsection (c), 
                $3,000,000; and
                    (C) to carry out subsection (d), 
                $31,000,000, of which $5,000,000 shall be used 
                to carry out paragraphs (3) through (5) of such 
                subsection.
            (2) Subsequent fiscal years.--There are authorized 
        to be appropriated such sums as may be necessary to 
        carry out this section for fiscal year 2008 and each 
        subsequent fiscal year.

SEC. 319F-1. [247D-6A] AUTHORITY FOR USE OF CERTAIN PROCEDURES 
                    REGARDING QUALIFIED COUNTERMEASURE RESEARCH AND 
                    DEVELOPMENT ACTIVITIES. \2\

    (a) In General.--
            (1) Authority.--In conducting and supporting 
        research and development activities regarding 
        countermeasures under section 319F(h), the Secretary 
        may conduct and support such activities in accordance 
        with this section and, in consultation with the 
        Director of the National Institutes of Health, as part 
        of the program under section 446, if the activities 
        concern qualified countermeasures.
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    \2\ Section 5 of Public Law 108-276 (118 Stat. 860) requires 
various reports regarding section 319F-1 and related provisions of law. 
Section 5 is included in the appendix to this compilation.
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            (2) Definitions.--In this section:
                    (A) Qualified countermeasure.--The term 
                ``qualified countermeasure'' means a drug (as 
                that term is defined by section 201(g)(1) of 
                the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 321(g)(1))), biological product (as that 
                term is defined by section 351(i) of this Act 
                (42 U.S.C. 262(i))), or device (as that term is 
                defined by section 201(h) of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 321(h))), 
                that the Secretary determines to be a priority 
                (consistent with sections 302(2) and 304(a) of 
                the Homeland Security Act of 2002) to--
                            (i) diagnose, mitigate, prevent, or 
                        treat harm from any biological agent 
                        (including organisms that cause an 
                        infectious disease) or toxin, chemical, 
                        radiological, or nuclear agent that may 
                        cause a public health emergency 
                        affecting national security; or
                            (ii) diagnose, mitigate, prevent, 
                        or treat harm from a condition that may 
                        result in adverse health consequences 
                        or death and may be caused by 
                        administering a drug, biological 
                        product, or device that is used as 
                        described in this subparagraph.
                    (B) Infectious disease.--The term 
                ``infectious disease'' means a disease 
                potentially caused by a pathogenic organism 
                (including a bacteria, virus, fungus, or 
                parasite) that is acquired by a person and that 
                reproduces in that person.
            (3) Interagency cooperation.--
                    (A) In general.--In carrying out activities 
                under this section, the Secretary is 
                authorized, subject to subparagraph (B), to 
                enter into interagency agreements and other 
                collaborative undertakings with other agencies 
                of the United States Government.
                    (B) Limitation.--An agreement or 
                undertaking under this paragraph shall not 
                authorize another agency to exercise the 
                authorities provided by this section.
            (4) Availability of facilities to the secretary.--
        In any grant, contract, or cooperative agreement 
        entered into under the authority provided in this 
        section with respect to a biocontainment laboratory or 
        other related or ancillary specialized research 
        facility that the Secretary determines necessary for 
        the purpose of performing, administering, or supporting 
        qualified countermeasure research and development, the 
        Secretary may provide that the facility that is the 
        object of such grant, contract, or cooperative 
        agreement shall be available as needed to the Secretary 
        to respond to public health emergencies affecting 
        national security.
            (5) Transfers of qualified countermeasures.--Each 
        agreement for an award of a grant, contract, or 
        cooperative agreement under section 319F(h) for the 
        development of a qualified countermeasure shall provide 
        that the recipient of the award will comply with all 
        applicable export-related controls with respect to such 
        countermeasure.
    (b) Expedited Procurement Authority.--
            (1) Increased simplified acquisition threshold for 
        qualified countermeasure procurements.--
                    (A) In general.--For any procurement by the 
                Secretary of property or services for use (as 
                determined by the Secretary) in performing, 
                administering, or supporting qualified 
                countermeasure research or development 
                activities under this section that the 
                Secretary determines necessary to respond to 
                pressing research and development needs under 
                this section, the amount specified in section 
                4(11) of the Office of Federal Procurement 
                Policy Act (41 U.S.C. 403(11)), as applicable 
                pursuant to section 302A(a) of the Federal 
                Property and Administrative Services Act of 
                1949 (41 U.S.C. 252a(a)), shall be deemed to be 
                $25,000,000 in the administration, with respect 
                to such procurement, of--
                            (i) section 303(g)(1)(A) of the 
                        Federal Property and Administrative 
                        Services Act of 1949 (41 U.S.C. 
                        253(g)(1)(A)) and its implementing 
                        regulations; and
                            (ii) section 302A(b) of such Act 
                        (41 U.S.C. 252a(b)) and its 
                        implementing regulations.
                    (B) Application of certain provisions.--
                Notwithstanding subparagraph (A) and the 
                provision of law and regulations referred to in 
                such subparagraph, each of the following 
                provisions shall apply to procurements 
                described in this paragraph to the same extent 
                that such provisions would apply to such 
                procurements in the absence of subparagraph 
                (A):
                            (i) Chapter 37 of title 40, United 
                        States Code (relating to contract work 
                        hours and safety standards).
                            (ii) Subsections (a) and (b) of 
                        section 7 of the Anti-Kickback Act of 
                        1986 (41 U.S.C. 57(a) and (b)).
                            (iii) Section 304C of the Federal 
                        Property and Administrative Services 
                        Act of 1949 (41 U.S.C. 254d) (relating 
                        to the examination of contractor 
                        records).
                            (iv) Section 3131 of title 40, 
                        United States Code (relating to bonds 
                        of contractors of public buildings or 
                        works).
                            (v) Subsection (a) of section 304 
                        of the Federal Property and 
                        Administrative Services Act of 1949 (41 
                        U.S.C. 254(a)) (relating to contingent 
                        fees to middlemen).
                            (vi) Section 6002 of the Solid 
                        Waste Disposal Act (42 U.S.C. 6962).
                            (vii) Section 1354 of title 31, 
                        United States Code (relating to the 
                        limitation on the use of appropriated 
                        funds for contracts with entities not 
                        meeting veterans employment reporting 
                        requirements).
                    (C) Internal controls to be instituted.--
                The Secretary shall institute appropriate 
                internal controls for procurements that are 
                under this paragraph, including requirements 
                with regard to documenting the justification 
                for use of the authority in this paragraph with 
                respect to the procurement involved.
                    (D) Authority to limit competition.--In 
                conducting a procurement under this paragraph, 
                the Secretary may not use the authority 
                provided for under subparagraph (A) to conduct 
                a procurement on a basis other than full and 
                open competition unless the Secretary 
                determines that the mission of the BioShield 
                Program under the Project BioShield Act of 2004 
                would be seriously impaired without such a 
                limitation.
            (2) Procedures other than full and open 
        competition.--
                    (A) In general.--In using the authority 
                provided in section 303(c)(1) of title III of 
                the Federal Property and Administrative 
                Services Act of 1949 (41 U.S.C. 253(c)(1)) to 
                use procedures other than competitive 
                procedures in the case of a procurement 
                described in paragraph (1) of this subsection, 
                the phrase ``available from only one 
                responsible source'' in such section 303(c)(1) 
                shall be deemed to mean ``available from only 
                one responsible source or only from a limited 
                number of responsible sources''.
                    (B) Relation to other authorities.--The 
                authority under subparagraph (A) is in addition 
                to any other authority to use procedures other 
                than competitive procedures.
                    (C) Applicable government-wide 
                regulations.--The Secretary shall implement 
                this paragraph in accordance with government-
                wide regulations implementing such section 
                303(c)(1) (including requirements that offers 
                be solicited from as many potential sources as 
                is practicable under the circumstances, that 
                required notices be published, and that 
                submitted offers be considered), as such 
                regulations apply to procurements for which an 
                agency has authority to use procedures other 
                than competitive procedures when the property 
                or services needed by the agency are available 
                from only one responsible source or only from a 
                limited number of responsible sources and no 
                other type of property or services will satisfy 
                the needs of the agency.
            (3) Increased micropurchase threshold.--
                    (A) In general.--For a procurement 
                described by paragraph (1), the amount 
                specified in subsections (c), (d), and (f) of 
                section 32 of the Office of Federal Procurement 
                Policy Act (41 U.S.C. 428) shall be deemed to 
                be $15,000 in the administration of that 
                section with respect to such procurement.
                    (B) Internal controls to be instituted.--
                The Secretary shall institute appropriate 
                internal controls for purchases that are under 
                this paragraph and that are greater than 
                $2,500.
                    (C) Exception to preference for purchase 
                card mechanism.--No provision of law 
                establishing a preference for using a 
                Government purchase card method for purchases 
                shall apply to purchases that are under this 
                paragraph and that are greater than $2,500.
            (4) Review.--
                    (A) Review allowed.--Notwithstanding 
                subsection (f), section 1491 of title 28, 
                United States Code, and section 3556 of title 
                31 of such Code, review of a contracting agency 
                decision relating to a procurement described in 
                paragraph (1) may be had only by filing a 
                protest--
                            (i) with a contracting agency; or
                            (ii) with the Comptroller General 
                        under subchapter V of chapter 35 of 
                        title 31, United States Code.
                    (B) Override of stay of contract award or 
                performance committed to agency discretion.--
                Notwithstanding section 1491 of title 28, 
                United States Code, and section 3553 of title 
                31 of such Code, the following authorizations 
                by the head of a procuring activity are 
                committed to agency discretion:
                            (i) An authorization under section 
                        3553(c)(2) of title 31, United States 
                        Code, to award a contract for a 
                        procurement described in paragraph (1) 
                        of this subsection.
                            (ii) An authorization under section 
                        3553(d)(3)(C) of such title to perform 
                        a contract for a procurement described 
                        in paragraph (1) of this subsection.
    (c) Authority to Expedite Peer Review.--
            (1) In general.--The Secretary may, as the 
        Secretary determines necessary to respond to pressing 
        qualified countermeasure research and development needs 
        under this section, employ such expedited peer review 
        procedures (including consultation with appropriate 
        scientific experts) as the Secretary, in consultation 
        with the Director of NIH, deems appropriate to obtain 
        assessment of scientific and technical merit and likely 
        contribution to the field of qualified countermeasure 
        research, in place of the peer review and advisory 
        council review procedures that would be required under 
        sections 301(a)(3), 405(b)(1)(B), 405(b)(2), 
        406(a)(3)(A), 492, and 494, as applicable to a grant, 
        contract, or cooperative agreement--
                    (A) that is for performing, administering, 
                or supporting qualified countermeasure research 
                and development activities; and
                    (B) the amount of which is not greater than 
                $1,500,000.
            (2) Subsequent phases of research.--The Secretary's 
        determination of whether to employ expedited peer 
        review with respect to any subsequent phases of a 
        research grant, contract, or cooperative agreement 
        under this section shall be determined without regard 
        to the peer review procedures used for any prior peer 
        review of that same grant, contract, or cooperative 
        agreement. Nothing in the preceding sentence may be 
        construed to impose any requirement with respect to 
        peer review not otherwise required under any other law 
        or regulation.
    (d) Authority for Personal Services Contracts.--
            (1) In general.--For the purpose of performing, 
        administering, or supporting qualified countermeasure 
        research and development activities, the Secretary may, 
        as the Secretary determines necessary to respond to 
        pressing qualified countermeasure research and 
        development needs under this section, obtain by 
        contract (in accordance with section 3109 of title 5, 
        United States Code, but without regard to the 
        limitations in such section on the period of service 
        and on pay) the personal services of experts or 
        consultants who have scientific or other professional 
        qualifications, except that in no case shall the 
        compensation provided to any such expert or consultant 
        exceed the daily equivalent of the annual rate of 
        compensation for the President.
            (2) Federal tort claims act coverage.--
                    (A) In general.--A person carrying out a 
                contract under paragraph (1), and an officer, 
                employee, or governing board member of such 
                person, shall, subject to a determination by 
                the Secretary, be deemed to be an employee of 
                the Department of Health and Human Services for 
                purposes of claims under sections 1346(b) and 
                2672 of title 28, United States Code, for money 
                damages for personal injury, including death, 
                resulting from performance of functions under 
                such contract.
                    (B) Exclusivity of remedy.--The remedy 
                provided by subparagraph (A) shall be exclusive 
                of any other civil action or proceeding by 
                reason of the same subject matter against the 
                entity involved (person, officer, employee, or 
                governing board member) for any act or omission 
                within the scope of the Federal Tort Claims 
                Act.
                    (C) Recourse in case of gross misconduct or 
                contract violation.--
                            (i) In general.--Should payment be 
                        made by the United States to any 
                        claimant bringing a claim under this 
                        paragraph, either by way of 
                        administrative determination, 
                        settlement, or court judgment, the 
                        United States shall have, 
                        notwithstanding any provision of State 
                        law, the right to recover against any 
                        entity identified in subparagraph (B) 
                        for that portion of the damages so 
                        awarded or paid, as well as interest 
                        and any costs of litigation, resulting 
                        from the failure of any such entity to 
                        carry out any obligation or 
                        responsibility assumed by such entity 
                        under a contract with the United States 
                        or from any grossly negligent or 
                        reckless conduct or intentional or 
                        willful misconduct on the part of such 
                        entity.
                            (ii) Venue.--The United States may 
                        maintain an action under this 
                        subparagraph against such entity in the 
                        district court of the United States in 
                        which such entity resides or has its 
                        principal place of business.
            (3) Internal controls to be instituted.--
                    (A) In general.--The Secretary shall 
                institute appropriate internal controls for 
                contracts under this subsection, including 
                procedures for the Secretary to make a 
                determination of whether a person, or an 
                officer, employee, or governing board member of 
                a person, is deemed to be an employee of the 
                Department of Health and Human Services 
                pursuant to paragraph (2).
                    (B) Determination of employee status to be 
                final.--A determination by the Secretary under 
                subparagraph (A) that a person, or an officer, 
                employee, or governing board member of a 
                person, is or is not deemed to be an employee 
                of the Department of Health and Human Services 
                shall be final and binding on the Secretary and 
                the Attorney General and other parties to any 
                civil action or proceeding.
            (4) Number of personal services contracts 
        limited.--The number of experts and consultants whose 
        personal services are obtained under paragraph (1) 
        shall not exceed 30 at any time.
    (e) Streamlined Personnel Authority.--
            (1) In general.--In addition to any other personnel 
        authorities, the Secretary may, as the Secretary 
        determines necessary to respond to pressing qualified 
        countermeasure research and development needs under 
        this section, without regard to those provisions of 
        title 5, United States Code, governing appointments in 
        the competitive service, and without regard to the 
        provisions of chapter 51 and subchapter III of chapter 
        53 of such title relating to classification and General 
        Schedule pay rates, appoint professional and technical 
        employees, not to exceed 30 such employees at any time, 
        to positions in the National Institutes of Health to 
        perform, administer, or support qualified 
        countermeasure research and development activities in 
        carrying out this section.
            (2) Limitations.--The authority provided for under 
        paragraph (1) shall be exercised in a manner that--
                    (A) recruits and appoints individuals based 
                solely on their abilities, knowledge, and 
                skills;
                    (B) does not discriminate for or against 
                any applicant for employment on any basis 
                described in section 2302(b)(1) of title 5, 
                United States Code;
                    (C) does not allow an official to appoint 
                an individual who is a relative (as defined in 
                section 3110(a)(3) of such title) of such 
                official;
                    (D) does not discriminate for or against an 
                individual because of the exercise of any 
                activity described in paragraph (9) or (10) of 
                section 2302(b) of such title; and
                    (E) accords a preference, among equally 
                qualified persons, to persons who are 
                preference eligibles (as defined in section 
                2108(3) of such title).
            (3) Internal controls to be instituted.--The 
        Secretary shall institute appropriate internal controls 
        for appointments under this subsection.
    (f) Actions Committed to Agency Discretion.--Actions by the 
Secretary under the authority of this section are committed to 
agency discretion.

SEC. 319F-2. [247D-6B] STRATEGIC NATIONAL STOCKPILE AND SECURITY 
                    COUNTERMEASURE PROCUREMENTS. \1\

    (a) Strategic National Stockpile.--
            (1) In general.--The Secretary, in collaboration 
        with the Director of the Centers for Disease Control 
        and Prevention, and in coordination with the Secretary 
        of Homeland Security (referred to in this section as 
        the ``Homeland Security Secretary''), shall maintain a 
        stockpile or stockpiles of drugs, vaccines and other 
        biological products, medical devices, and other 
        supplies in such numbers, types, and amounts as are 
        determined by the Secretary to be appropriate and 
        practicable, taking into account other available 
        sources, to provide for the emergency health security 
        of the United States, including the emergency health 
        security of children and other vulnerable populations, 
        in the event of a bioterrorist attack or other public 
        health emergency. The Secretary shall conduct an annual 
        review (taking into account at-risk individuals) of the 
        contents of the stockpile, including non-pharmaceutical 
        supplies, and make necessary additions or modifications 
        to the contents based on such review.
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    \1\ Section 5 of Public Law 108-276 (118 Stat. 860) requires 
various reports regarding section 319F-2 and related provisions of law. 
Section 5 is included in the appendix to this compilation.
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            (2) Procedures.--The Secretary, in managing the 
        stockpile under paragraph (1), shall--
                    (A) consult with the working group under 
                section 319F(a);
                    (B) ensure that adequate procedures are 
                followed with respect to such stockpile for 
                inventory management and accounting, and for 
                the physical security of the stockpile;
                    (C) in consultation with Federal, State, 
                and local officials, take into consideration 
                the timing and location of special events;
                    (D) review and revise, as appropriate, the 
                contents of the stockpile on a regular basis to 
                ensure that emerging threats, advanced 
                technologies, and new countermeasures are 
                adequately considered;
                    (E) devise plans for the effective and 
                timely supply-chain management of the 
                stockpile, in consultation with appropriate 
                Federal, State and local agencies, and the 
                public and private health care infrastructure;
                    (F) deploy the stockpile as required by the 
                Secretary of Homeland Security to respond to an 
                actual or potential emergency;
                    (G) deploy the stockpile at the discretion 
                of the Secretary to respond to an actual or 
                potential public health emergency or other 
                situation in which deployment is necessary to 
                protect the public health or safety; and
                    (H) ensure the adequate physical security 
                of the stockpile.
    (b) Smallpox Vaccine Development.--
            (1) In general.--The Secretary shall award 
        contracts, enter into cooperative agreements, or carry 
        out such other activities as may reasonably be required 
        in order to ensure that the stockpile under subsection 
        (a) includes an amount of vaccine against smallpox as 
        determined by such Secretary to be sufficient to meet 
        the health security needs of the United States.
            (2) Rule of construction.--Nothing in this section 
        shall be construed to limit the private distribution, 
        purchase, or sale of vaccines from sources other than 
        the stockpile described in subsection (a).
    (c) Additional Authority Regarding Procurement of Certain 
Countermeasures; Availability of Special Reserve Fund.--
            (1) In general.--
                    (A) Use of fund.--A security countermeasure 
                may, in accordance with this subsection, be 
                procured with amounts in the special reserve 
                fund under paragraph (10).
                    (B) Security countermeasure.--For purposes 
                of this subsection, the term ``security 
                countermeasure'' means a drug (as that term is 
                defined by section 201(g)(1) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 
                321(g)(1))), biological product (as that term 
                is defined by section 351(i) of this Act (42 
                U.S.C. 262(i))), or device (as that term is 
                defined by section 201(h) of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 321(h))) 
                that--
                            (i)(I) the Secretary determines to 
                        be a priority (consistent with sections 
                        302(2) and 304(a) of the Homeland 
                        Security Act of 2002) to diagnose, 
                        mitigate, prevent, or treat harm from 
                        any biological, chemical, radiological, 
                        or nuclear agent identified as a 
                        material threat under paragraph 
                        (2)(A)(ii), or to diagnose, mitigate, 
                        prevent, or treat harm from a condition 
                        that may result in adverse health 
                        consequences or death and may be caused 
                        by administering a drug, biological 
                        product, or device against such an 
                        agent;
                            (II) the Secretary determines under 
                        paragraph (2)(B)(ii) to be a necessary 
                        countermeasure; and
                            (III)(aa) is approved or cleared 
                        under chapter V of the Federal Food, 
                        Drug, and Cosmetic Act or licensed 
                        under section 351 of this Act; or
                            (bb) is a countermeasure for which 
                        the Secretary determines that 
                        sufficient and satisfactory clinical 
                        experience or research data (including 
                        data, if available, from pre-clinical 
                        and clinical trials) support a 
                        reasonable conclusion that the 
                        countermeasure will qualify for 
                        approval or licensing within eight 
                        years after the date of a determination 
                        under paragraph (5); or
                            (ii) is authorized for emergency 
                        use under section 564 of the Federal 
                        Food, Drug, and Cosmetic Act.
            (2) Determination of material threats.--
                    (A) Material threat.--The Homeland Security 
                Secretary, in consultation with the Secretary 
                and the heads of other agencies as appropriate, 
                shall on an ongoing basis--
                            (i) assess current and emerging 
                        threats of chemical, biological, 
                        radiological, and nuclear agents; and
                            (ii) determine which of such agents 
                        present a material threat against the 
                        United States population sufficient to 
                        affect national security.
                    (B) Public health impact; necessary 
                countermeasures.--The Secretary shall on an 
                ongoing basis--
                            (i) assess the potential public 
                        health consequences for the United 
                        States population of exposure to agents 
                        identified under subparagraph (A)(ii); 
                        and
                            (ii) determine, on the basis of 
                        such assessment, the agents identified 
                        under subparagraph (A)(ii) for which 
                        countermeasures are necessary to 
                        protect the public health.
                    (C) Notice to congress.--The Secretary and 
                the Homeland Security Secretary shall promptly 
                notify the designated congressional committees 
                (as defined in paragraph (10)) that a 
                determination has been made pursuant to 
                subparagraph (A) or (B).
                    (D) Assuring access to threat 
                information.--In making the assessment and 
                determination required under subparagraph (A), 
                the Homeland Security Secretary shall use all 
                relevant information to which such Secretary is 
                entitled under section 202 of the Homeland 
                Security Act of 2002, including but not limited 
                to information, regardless of its level of 
                classification, relating to current and 
                emerging threats of chemical, biological, 
                radiological, and nuclear agents.
            (3) Assessment of availability and appropriateness 
        of countermeasures.--
                    (A) In general.--The Secretary, in 
                consultation with the Homeland Security 
                Secretary, shall assess on an ongoing basis the 
                availability and appropriateness of specific 
                countermeasures to address specific threats 
                identified under paragraph (2).
                    (B) Information.--The Secretary shall 
                institute a process for making publicly 
                available the results of assessments under 
                subparagraph (A) while withholding such 
                information as--
                            (i) would, in the judgment of the 
                        Secretary, tend to reveal public health 
                        vulnerabilities; or
                            (ii) would otherwise be exempt from 
                        disclosure under section 552 of title 
                        5, United States Code.
            (4) Call for development of countermeasures; 
        commitment for recommendation for procurement.--
                    (A) Proposal to the president.--If, 
                pursuant to an assessment under paragraph (3), 
                the Homeland Security Secretary and the 
                Secretary make a determination that a 
                countermeasure would be appropriate but is 
                either
                currently not developed or unavailable for 
                procurement as a security countermeasure or is 
                approved, licensed, or cleared only for 
                alternative uses, such Secretaries may jointly 
                submit to the President a proposal to--
                            (i) issue a call for the 
                        development of such countermeasure; and
                            (ii) make a commitment that, upon 
                        the first development of such 
                        countermeasure that meets the 
                        conditions for procurement under 
                        paragraph (5), the Secretaries will, 
                        based in part on information obtained 
                        pursuant to such call, make a 
                        recommendation under paragraph (6) that 
                        the special reserve fund under 
                        paragraph (10) be made available for 
                        the procurement of such countermeasure.
                    (B) Countermeasure specifications.--The 
                Homeland Security Secretary and the Secretary 
                shall, to the extent practicable, include in 
                the proposal under subparagraph (A)--
                            (i) estimated quantity of purchase 
                        (in the form of number of doses or 
                        number of effective courses of 
                        treatments regardless of dosage form);
                            (ii) necessary measures of minimum 
                        safety and effectiveness;
                            (iii) estimated price for each dose 
                        or effective course of treatment 
                        regardless of dosage form; and
                            (iv) other information that may be 
                        necessary to encourage and facilitate 
                        research, development, and manufacture 
                        of the countermeasure or to provide 
                        specifications for the countermeasure.
                    (C) Presidential approval.--If the 
                President approves a proposal under 
                subparagraph (A), the Homeland Security 
                Secretary and the Secretary shall make known to 
                persons who may respond to a call for the 
                countermeasure involved--
                            (i) the call for the 
                        countermeasure;
                            (ii) specifications for the 
                        countermeasure under subparagraph (B); 
                        and
                            (iii) the commitment described in 
                        subparagraph (A)(ii).
            (5) Secretary's determination of countermeasures 
        appropriate for funding from special reserve fund.--
                    (A) In general.--The Secretary, in 
                accordance with the provisions of this 
                paragraph, shall identify specific security 
                countermeasures that the Secretary determines, 
                in consultation with the Homeland Security 
                Secretary, to be appropriate for inclusion in 
                the stockpile under subsection (a) pursuant to 
                procurements made with amounts in the special 
                reserve fund under paragraph (10) (referred to 
                in this subsection individually as a 
                ``procurement under this subsection'').
                    (B) Requirements.--In making a 
                determination under subparagraph (A) with 
                respect to a security countermeasure, the 
                Secretary shall determine and consider the 
                following:
                            (i) The quantities of the product 
                        that will be needed to meet the 
                        stockpile needs.
                            (ii) The feasibility of production 
                        and delivery within eight years of 
                        sufficient quantities of the product.
                            (iii) Whether there is a lack of a 
                        significant commercial market for the 
                        product at the time of procurement, 
                        other than as a security 
                        countermeasure.
            (6) Recommendation for president's approval.--
                    (A) Recommendation for procurement.--In the 
                case of a security countermeasure that the 
                Secretary has, in accordance with paragraphs 
                (3) and (5), determined to be appropriate for 
                procurement under this subsection, the Homeland 
                Security Secretary and the Secretary shall 
                jointly submit to the President, in 
                coordination with the Director of the Office of 
                Management and Budget, a recommendation that 
                the special reserve fund under paragraph (10) 
                be made available for the procurement of such 
                countermeasure.
                    (B) Presidential approval.--The special 
                reserve fund under paragraph (10) is available 
                for a procurement of a security countermeasure 
                only if the President has approved a 
                recommendation under subparagraph (A) regarding 
                the countermeasure.
                    (C) Notice to designated congressional 
                committees.--The Secretary and the Homeland 
                Security Secretary shall notify the designated 
                congressional committees of each decision of 
                the President to approve a recommendation under 
                subparagraph (A). Such notice shall include an 
                explanation of the decision to make available 
                the special reserve fund under paragraph (10) 
                for procurement of such a countermeasure, 
                including, where available, the number of, 
                nature of, and other information concerning 
                potential suppliers of such countermeasure, and 
                whether other potential suppliers of the same 
                or similar countermeasures were considered and 
                rejected for procurement under this section and 
                the reasons therefor.
                    (D) Subsequent specific countermeasures.--
                Procurement under this subsection of a security 
                countermeasure for a particular purpose does 
                not preclude the subsequent procurement under 
                this subsection of any other security 
                countermeasure for such purpose if the 
                Secretary has determined under paragraph (5)(A) 
                that such countermeasure is appropriate for 
                inclusion in the stockpile and if, as 
                determined by the Secretary, such 
                countermeasure provides improved safety or 
                effectiveness, or for other reasons enhances 
                preparedness to respond to threats of use of a 
                biological, chemical, radiological, or nuclear 
                agent. Such a determination by the Secretary is 
                committed to agency discretion.
                    (E) Rule of construction.--Recommendations 
                and approvals under this paragraph apply solely 
                to determinations that the special reserve fund 
                under paragraph (10) will be made available for 
                a procurement of a security countermeasure, and 
                not to the substance of contracts for such 
                procurement or other matters relating to awards 
                of such contracts.
            (7) Procurement.--
                    (A) In general.--For purposes of a 
                procurement under this subsection that is 
                approved by the President under paragraph (6), 
                the Homeland Security Secretary and the 
                Secretary shall have responsibilities in 
                accordance with subparagraphs (B) and (C).
                    (B) Interagency agreement; cost.--The 
                Homeland Security Secretary shall enter into an 
                agreement with the Secretary for procurement of 
                a security countermeasure in accordance with 
                the provisions of this paragraph. The special 
                reserve fund under paragraph (10) shall be 
                available for payments made by the Secretary to 
                a vendor for such procurement.
                    (C) Procurement.--
                            (i) In general.--The Secretary 
                        shall be responsible for--
                                    (I) arranging for 
                                procurement of a security 
                                countermeasure, including 
                                negotiating terms (including 
                                quantity, production schedule, 
                                and price) of, and entering 
                                into, contracts and cooperative 
                                agreements, and for carrying 
                                out such other activities as 
                                may reasonably be required, in 
                                accordance with the provisions 
                                of this subparagraph; and
                                    (II) promulgating such 
                                regulations as the Secretary 
                                determines necessary to 
                                implement the provisions of 
                                this subsection.
                            (ii) Contract terms.--A contract 
                        for procurements under this subsection 
                        shall (or, as specified below, may) 
                        include the following terms:
                                    (I) Payment conditioned on 
                                delivery.--The contract shall 
                                provide that no payment may be 
                                made until delivery of a 
                                portion, acceptable to the 
                                Secretary, of the total number 
                                of units contracted for, except 
                                that, notwithstanding any other 
                                provision of law, the contract 
                                may provide that, if the 
                                Secretary determines (in the 
                                Secretary's discretion) that an 
                                advance payment, partial 
                                payment for significant 
                                milestones, or payment to 
                                increase manufacturing capacity 
                                is necessary to ensure success 
                                of a project, the Secretary 
                                shall pay an amount, not to 
                                exceed 10 percent of the 
                                contract amount, in advance of 
                                delivery. The Secretary shall, 
                                to the extent practicable, make 
                                the determination of advance 
                                payment at the same time as the 
                                issuance of a solicitation. The 
                                contract shall provide that 
                                such advance payment is 
                                required to be repaid if there 
                                is a failure to perform by the 
                                vendor under the contract. The 
                                contract may also provide for 
                                additional advance payments of 
                                5 percent each for meeting the 
                                milestones specified in such 
                                contract, except that such 
                                payments shall not exceed 50 
                                percent of the total contract 
                                amount. If the specified 
                                milestones are reached, the 
                                advanced payments of 5 percent 
                                shall not be required to be 
                                repaid. Nothing in this 
                                subclause shall be construed as 
                                affecting the rights of vendors 
                                under provisions of law or 
                                regulation (including the 
                                Federal Acquisition Regulation) 
                                relating to the termination of 
                                contracts for the convenience 
                                of the Government.
                                    (II) Discounted payment.--
                                The contract may provide for a 
                                discounted price per unit of a 
                                product that is not licensed, 
                                cleared, or approved as 
                                described in paragraph 
                                (1)(B)(i)(III)(aa) at the time 
                                of delivery, and may provide 
                                for payment of an additional 
                                amount per unit if the product 
                                becomes so licensed, cleared, 
                                or approved before the 
                                expiration date of the contract 
                                (including an additional amount 
                                per unit of product delivered 
                                before the effective date of 
                                such licensing, clearance, or 
                                approval).
                                    (III) Contract duration.--
                                The contract shall be for a 
                                period not to exceed five 
                                years, except that, in first 
                                awarding the contract, the 
                                Secretary may provide for a 
                                longer duration, not exceeding 
                                eight years, if the Secretary 
                                determines that complexities or 
                                other difficulties in 
                                performance under the contract 
                                justify such a period. The 
                                contract shall be renewable for 
                                additional periods, none of 
                                which shall exceed five years.
                                    (IV) Storage by vendor.--
                                The contract may provide that 
                                the vendor will provide storage 
                                for stocks of a product 
                                delivered to the ownership of 
                                the Federal Government under 
                                the contract, for such period 
                                and under such terms and 
                                conditions as the Secretary may 
                                specify, and in such case 
                                amounts from the special 
                                reserve fund under paragraph 
                                (10) shall be available for 
                                costs of shipping, handling, 
                                storage, and related costs for 
                                such product.
                                    (V) Product approval.--The 
                                contract shall provide that the 
                                vendor seek approval, 
                                clearance, or licensing of the 
                                product from the Secretary; for 
                                a timetable for the development 
                                of data and other information 
                                to support such approval, 
                                clearance, or licensing; and 
                                that the Secretary may waive 
                                part or all of this contract 
                                term on request of the vendor 
                                or on the initiative of the 
                                Secretary.
                                    (VI) Non-stockpile 
                                transfers of security 
                                countermeasures.--The contract 
                                shall provide that the vendor 
                                will comply with all applicable 
                                export-related controls with 
                                respect to such countermeasure.
                                    (VII) Sales exclusivity.--
                                The contract may provide that 
                                the vendor is the exclusive 
                                supplier of the product to the 
                                Federal Government for a 
                                specified period of time, not 
                                to exceed the term of the 
                                contract, on the condition that 
                                the vendor is able to satisfy 
                                the needs of the Government. 
                                During the agreed period of 
                                sales exclusivity, the vendor 
                                shall not assign its rights of 
                                sales exclusivity to another 
                                entity or entities without 
                                approval by the Secretary. Such 
                                a sales exclusivity provision 
                                in such a contract shall 
                                constitute a valid basis for a 
                                sole source procurement under 
                                section 303(c)(1) of the 
                                Federal Property and 
                                Administrative Services Act of 
                                1949 (41 U.S.C. 253(c)(1)).
                                    (VIII) Warm based surge 
                                capacity.--The contract may 
                                provide that the vendor 
                                establish domestic 
                                manufacturing capacity of the 
                                product to ensure that 
                                additional production of the 
                                product is available in the 
                                event that the Secretary 
                                determines that there is a need 
                                to quickly purchase additional 
                                quantities of the product. Such 
                                contract may provide a fee to 
                                the vendor for establishing and 
                                maintaining such capacity in 
                                excess of the initial 
                                requirement for the purchase of 
                                the product. Additionally, the 
                                cost of maintaining the 
                                domestic manufacturing capacity 
                                shall be an allowable and 
                                allocable direct cost of the 
                                contract.
                                    (IX) Contract terms.--The 
                                Secretary, in any contract for 
                                procurement under this section, 
                                may specify--
                                            (aa) the dosing and 
                                        administration 
                                        requirements for 
                                        countermeasures to be 
                                        developed and procured;
                                            (bb) the amount of 
                                        funding that will be 
                                        dedicated by the 
                                        Secretary for 
                                        development and 
                                        acquisition of the 
                                        countermeasure; and
                                            (cc) the 
                                        specifications the 
                                        countermeasure must 
                                        meet to qualify for 
                                        procurement under a 
                                        contract under this 
                                        section.
                            (iii) Availability of simplified 
                        acquisition procedures.--
                                    (I) In general.--If the 
                                Secretary determines that there 
                                is a pressing need for a 
                                procurement of a specific 
                                countermeasure, the amount of 
                                the procurement under this 
                                subsection shall be deemed to 
                                be below the threshold amount 
                                specified in section 4(11) of 
                                the Office of Federal 
                                Procurement Policy Act (41 
                                U.S.C. 403(11)), for purposes 
                                of application to such 
                                procurement, pursuant to 
                                section 302A(a) of the Federal 
                                Property and Administrative 
                                Services Act of 1949 (41 U.S.C. 
                                252a(a)), of--
                                            (aa) section 
                                        303(g)(1)(A) of the 
                                        Federal Property and 
                                        Administrative Services 
                                        Act of 1949 (41 U.S.C. 
                                        253(g)(1)(A)) and its 
                                        implementing 
                                        regulations; and
                                            (bb) section 
                                        302A(b) of such Act (41 
                                        U.S.C. 252a(b)) and its 
                                        implementing 
                                        regulations.
                                    (II) Application of certain 
                                provisions.--Notwithstanding 
                                subclause (I) and the provision 
                                of law and regulations referred 
                                to in such clause, each of the 
                                following provisions shall 
                                apply to procurements described 
                                in this clause to the same 
                                extent that such provisions 
                                would apply to such 
                                procurements in the absence of 
                                subclause (I):
                                            (aa) Chapter 37 of 
                                        title 40, United States 
                                        Code (relating to 
                                        contract work hours and 
                                        safety standards).
                                            (bb) Subsections 
                                        (a) and (b) of section 
                                        7 of the Anti-Kickback 
                                        Act of 1986 (41 U.S.C. 
                                        57(a) and (b)).
                                            (cc) Section 304C 
                                        of the Federal Property 
                                        and Administrative 
                                        Services Act of 1949 
                                        (41 U.S.C. 254d) 
                                        (relating to the 
                                        examination of 
                                        contractor records).
                                            (dd) Section 3131 
                                        of title 40, United 
                                        States Code (relating 
                                        to bonds of contractors 
                                        of public buildings or 
                                        works).
                                            (ee) Subsection (a) 
                                        of section 304 of the 
                                        Federal Property and 
                                        Administrative Services 
                                        Act of 1949 (41 U.S.C. 
                                        254(a)) (relating to 
                                        contingent fees to 
                                        middlemen).
                                            (ff) Section 6002 
                                        of the Solid Waste 
                                        Disposal Act (42 U.S.C. 
                                        6962).
                                            (gg) Section 1354 
                                        of title 31, United 
                                        States Code (relating 
                                        to the limitation on 
                                        the use of appropriated 
                                        funds for contracts 
                                        with entities not 
                                        meeting veterans 
                                        employment reporting 
                                        requirements).
                                    (III) Internal controls to 
                                be established.--The Secretary 
                                shall establish appropriate 
                                internal controls for 
                                procurements made under this 
                                clause, including requirements 
                                with respect to documentation 
                                of the justification for the 
                                use of the authority provided 
                                under this paragraph with 
                                respect to the procurement 
                                involved.
                                    (IV) Authority to limit 
                                competition.--In conducting a 
                                procurement under this 
                                subparagraph, the Secretary may 
                                not use the authority provided 
                                for under subclause (I) to 
                                conduct a procurement on a 
                                basis other than full and open 
                                competition unless the 
                                Secretary determines that the 
                                mission of the BioShield 
                                Program under the Project 
                                BioShield Act of 2004 would be 
                                seriously impaired without such 
                                a limitation.
                            (iv) Procedures other than full and 
                        open competition.--
                                    (I) In general.--In using 
                                the authority provided in 
                                section 303(c)(1) of title III 
                                of the Federal Property and 
                                Administrative Services Act of 
                                1949 (41 U.S.C. 253(c)(1)) to 
                                use procedures other than 
                                competitive procedures in the 
                                case of a procurement under 
                                this subsection, the phrase 
                                ``available from only one 
                                responsible source'' in such 
                                section 303(c)(1) shall be 
                                deemed to mean ``available from 
                                only one responsible source or 
                                only from a limited number of 
                                responsible sources''.
                                    (II) Relation to other 
                                authorities.--The authority 
                                under subclause (I) is in 
                                addition to any other authority 
                                to use procedures other than 
                                competitive procedures.
                                    (III) Applicable 
                                government-wide regulations.--
                                The Secretary shall implement 
                                this clause in accordance with 
                                government-wide regulations 
                                implementing such section 
                                303(c)(1) (including 
                                requirements that offers be 
                                solicited from as many 
                                potential sources as is 
                                practicable under the 
                                circumstances, that required 
                                notices be published, and that 
                                submitted offers be 
                                considered), as such 
                                regulations apply to 
                                procurements for which an 
                                agency has authority to use 
                                procedures other than 
                                competitive procedures when the 
                                property or services needed by 
                                the agency are available from 
                                only one responsible source or 
                                only from a limited number of 
                                responsible sources and no 
                                other type of property or 
                                services will satisfy the needs 
                                of the agency.
                            (v) Premium provision in multiple 
                        award contracts.--
                                    (I) In general.--If, under 
                                this subsection, the Secretary 
                                enters into contracts with more 
                                than one vendor to procure a 
                                security countermeasure, such 
                                Secretary may, notwithstanding 
                                any other provision of law, 
                                include in each of such 
                                contracts a provision that--
                                            (aa) identifies an 
                                        increment of the total 
                                        quantity of security 
                                        countermeasure 
                                        required, whether by 
                                        percentage or by 
                                        numbers of units; and
                                            (bb) promises to 
                                        pay one or more 
                                        specified premiums 
                                        based on the priority 
                                        of such vendors' 
                                        production and delivery 
                                        of the increment 
                                        identified under item 
                                        (aa), in accordance 
                                        with the terms and 
                                        conditions of the 
                                        contract.
                                    (II) Determination of 
                                government's requirement not 
                                reviewable.--If the Secretary 
                                includes in each of a set of 
                                contracts a provision as 
                                described in subclause (I), 
                                such Secretary's determination 
                                of the total quantity of 
                                security countermeasure 
                                required, and any amendment of 
                                such determination, is 
                                committed to agency discretion.
                            (vi) Extension of closing date for 
                        receipt of proposals not reviewable.--A 
                        decision by the Secretary to extend the 
                        closing date for receipt of proposals 
                        for a procurement under this subsection 
                        is committed to agency discretion.
                            (vii) Limiting competition to 
                        sources responding to request for 
                        information.--In conducting a 
                        procurement under this subsection, the 
                        Secretary may exclude a source that has 
                        not responded to a request for 
                        information under section 303A(a)(1)(B) 
                        of the Federal Property and 
                        Administrative Services Act of 1949 (41 
                        U.S.C. 253a(a)(1)(B)) if such request 
                        has given notice that the Secretary may 
                        so exclude such a source.
            (8) Interagency cooperation.--
                    (A) In general.--In carrying out activities 
                under this section, the Homeland Security 
                Secretary and the Secretary are authorized, 
                subject to subparagraph (B), to enter into 
                interagency agreements and other collaborative 
                undertakings with other agencies of the United 
                States Government. Such agreements may allow 
                other executive agencies to order qualified and 
                security countermeasures under procurement 
                contracts or other agreements established by 
                the Secretary. Such ordering process (including 
                transfers of appropriated funds between an 
                agency and the Department of Health and Human 
                Services as reimbursements for such orders for 
                countermeasures) may be conducted under the 
                authority of section 1535 of title 31, United 
                States Code, except that all such orders shall 
                be processed under the terms established under 
                this subsection for the procurement of 
                countermeasures.
                    (B) Limitation.--An agreement or 
                undertaking under this paragraph shall not 
                authorize another agency to exercise the 
                authorities provided by this section to the 
                Homeland Security Secretary or to the 
                Secretary.
            (9) Restrictions on use of funds.--Amounts in the 
        special reserve fund under paragraph (10) shall not be 
        used to pay--
                    (A) costs for the purchase of vaccines 
                under procurement contracts entered into before 
                the date of the enactment of the Project 
                BioShield Act of 2004; or
                    (B) costs other than payments made by the 
                Secretary to a vendor for a procurement of a 
                security countermeasure under paragraph (7).
            (10) Definitions.--
                    (A) Special reserve fund.--For purposes of 
                this subsection, the term ``special reserve 
                fund'' has the meaning given such term in 
                section 510 of the Homeland Security Act of 
                2002 \1\.
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    \1\ Subsections (a) through (c) of such section provide as follows:
    (a) Authorization of Appropriations.--For the procurement of 
security countermeasures under section 319F-2(c) of the Public Health 
Service Act (referred to in this section as the ``security 
countermeasures program''), there is authorized to be appropriated up 
to $5,593,000,000 for the fiscal years 2004 through 2013. Of the 
amounts appropriated under the preceding sentence, not to exceed 
$3,418,000,000 may be obligated during the fiscal years 2004 through 
2008, of which not to exceed $890,000,000 may be obligated during 
fiscal year 2004.
    (b) Special Reserve Fund.--For purposes of the security 
countermeasures program, the term ``special reserve fund'' means the 
``Biodefense Countermeasures'' appropriations account or any other 
appropriation made under subsection (a).
    (c) Availability.--Amounts appropriated under subsection (a) become 
available for a procurement under the security countermeasures program 
only upon the approval by the President of such availability for the 
procurement in accordance with paragraph (6)(B) of such program.
---------------------------------------------------------------------------
                    (B) Designated congressional committees.--
                For purposes of this section, the term 
                ``designated congressional committees'' means 
                the following committees of the Congress:
                            (i) In the House of 
                        Representatives: the Committee on 
                        Energy and Commerce, the Committee on 
                        Appropriations, the Committee on 
                        Government Reform, and the Select 
                        Committee on Homeland Security (or any 
                        successor to the Select Committee).
                            (ii) In the Senate: the appropriate 
                        committees.
    (d) Disclosures.--No Federal agency shall disclose under 
section 552 of title 5, United States Code, any information 
identifying the location at which materials in the stockpile 
under subsection (a) are stored.
    (e) Definition.--For purposes of subsection (a), the term 
``stockpile'' includes--
            (1) a physical accumulation (at one or more 
        locations) of the supplies described in subsection (a); 
        or
            (2) a contractual agreement between the Secretary 
        and a vendor or vendors under which such vendor or 
        vendors agree to provide to such Secretary supplies 
        described in subsection (a).
    (f) Authorization of Appropriations.--
            (1) Strategic national stockpile.--For the purpose 
        of carrying out subsection (a), there are authorized to 
        be appropriated $640,000,000 for fiscal year 2002, and 
        such sums as may be necessary for each of fiscal years 
        2003 through 2006. Such authorization is in addition to 
        amounts in the special reserve fund referred to in 
        subsection (c)(10)(A).
            (2) Smallpox vaccine development.--For the purpose 
        of carrying out subsection (b), there are authorized to 
        be appropriated $509,000,000 for fiscal year 2002, and 
        such sums as may be necessary for each of fiscal years 
        2003 through 2006.

SEC. 319F-3. [247D-6D] TARGETED LIABILITY PROTECTIONS FOR PANDEMIC AND 
                    EPIDEMIC PRODUCTS AND SECURITY COUNTERMEASURES.

    (a) Liability Protections.--
            (1) In general.--Subject to the other provisions of 
        this section, a covered person shall be immune from 
        suit and liability under Federal and State law with 
        respect to all claims for loss caused by, arising out 
        of, relating to, or resulting from the administration 
        to or the use by an individual of a covered 
        countermeasure if a declaration under subsection (b) 
        has been issued with respect to such countermeasure.
            (2) Scope of claims for loss.--
                    (A) Loss.--For purposes of this section, 
                the term ``loss'' means any type of loss, 
                including--
                            (i) death;
                            (ii) physical, mental, or emotional 
                        injury, illness, disability, or 
                        condition;
                            (iii) fear of physical, mental, or 
                        emotional injury, illness, disability, 
                        or condition, including any need for 
                        medical monitoring; and
                            (iv) loss of or damage to property, 
                        including business interruption loss.
                 Each of clauses (i) through (iv) applies 
                without regard to the date of the occurrence, 
                presentation, or discovery of the loss 
                described in the clause.
                    (B) Scope.--The immunity under paragraph 
                (1) applies to any claim for loss that has a 
                causal relationship with the administration to 
                or use by an individual of a covered 
                countermeasure, including a causal relationship 
                with the design, development, clinical testing 
                or investigation, manufacture, labeling, 
                distribution, formulation, packaging, 
                marketing, promotion, sale, purchase, donation, 
                dispensing, prescribing, administration, 
                licensing, or use of such countermeasure.
            (3) Certain conditions.--Subject to the other 
        provisions of this section, immunity under paragraph 
        (1) with respect to a covered countermeasure applies 
        only if--
                    (A) the countermeasure was administered or 
                used during the effective period of the 
                declaration that was issued under subsection 
                (b) with respect to the countermeasure;
                    (B) the countermeasure was administered or 
                used for the category or categories of 
                diseases, health conditions, or threats to 
                health specified in the declaration; and
                    (C) in addition, in the case of a covered 
                person who is a program planner or qualified 
                person with respect to the administration or 
                use of the countermeasure, the countermeasure 
                was administered to or used by an individual 
                who--
                            (i) was in a population specified 
                        by the declaration; and
                            (ii) was at the time of 
                        administration physically present in a 
                        geographic area specified by the 
                        declaration or had a connection to such 
                        area specified in the declaration.
            (4) Applicability of certain conditions.--With 
        respect to immunity under paragraph (1) and subject to 
        the other provisions of this section:
                    (A) In the case of a covered person who is 
                a manufacturer or distributor of the covered 
                countermeasure involved, the immunity applies 
                without regard to whether such countermeasure 
                was administered to or used by an individual in 
                accordance with the conditions described in 
                paragraph (3)(C).
                    (B) In the case of a covered person who is 
                a program planner or qualified person with 
                respect to the administration or use of the 
                covered countermeasure, the scope of immunity 
                includes circumstances in which the 
                countermeasure was administered to or used by 
                an individual in circumstances in which the 
                covered person reasonably could have believed 
                that the countermeasure was administered or 
                used in accordance with the conditions 
                described in paragraph (3)(C).
            (5) Effect of distribution method.--The provisions 
        of this section apply to a covered countermeasure 
        regardless of whether such countermeasure is obtained 
        by donation, commercial sale, or any other means of 
        distribution, except to the extent that, under 
        paragraph (2)(E) of subsection (b), the declaration 
        under such subsection provides that subsection (a) 
        applies only to covered countermeasures obtained 
        through a particular means of distribution.
            (6) Rebuttable presumption.--For purposes of 
        paragraph (1), there shall be a rebuttable presumption 
        that any administration or use, during the effective 
        period of the emergency declaration by the Secretary 
        under subsection (b), of a covered countermeasure shall 
        have been for the category or categories of diseases, 
        health conditions, or threats to health with respect to 
        which such declaration was issued.
    (b) Declaration by Secretary.--
            (1) Authority to issue declaration.--Subject to 
        paragraph (2), if the Secretary makes a determination 
        that a disease or other health condition or other 
        threat to health constitutes a public health emergency, 
        or that there is a credible risk that the disease, 
        condition, or threat may in the future constitute such 
        an emergency, the Secretary may make a declaration, 
        through publication in the Federal Register, 
        recommending, under conditions as the Secretary may 
        specify, the manufacture, testing, development, 
        distribution, administration, or use of one or more 
        covered countermeasures, and stating that subsection 
        (a) is in effect with respect to the activities so 
        recommended.
            (2) Contents.--In issuing a declaration under 
        paragraph (1), the Secretary shall identify, for each 
        covered countermeasure specified in the declaration--
                    (A) the category or categories of diseases, 
                health conditions, or threats to health for 
                which the Secretary recommends the 
                administration or use of the countermeasure;
                    (B) the period or periods during which, 
                including as modified by paragraph (3), 
                subsection (a) is in effect, which period or 
                periods may be designated by dates, or by 
                milestones or other description of events, 
                including factors specified in paragraph (6);
                    (C) the population or populations of 
                individuals for which subsection (a) is in 
                effect with respect to the administration or 
                use of the countermeasure (which may be a 
                specification that such subsection applies 
                without geographic limitation to all 
                individuals);
                    (D) the geographic area or areas for which 
                subsection (a) is in effect with respect to the 
                administration or use of the countermeasure 
                (which may be a specification that such 
                subsection applies without geographic 
                limitation), including, with respect to 
                individuals in the populations identified under 
                subparagraph (C), a specification, as 
                determined appropriate by the Secretary, of 
                whether the declaration applies only to 
                individuals physically present in such areas or 
                whether in addition the declaration applies to 
                individuals who have a connection to such 
                areas, which connection is described in the 
                declaration; and
                    (E) whether subsection (a) is effective 
                only to a particular means of distribution as 
                provided in subsection (a)(5) for obtaining the 
                countermeasure, and if so, the particular means 
                to which such subsection is effective.
            (3) Effective period of declaration.--
                    (A) Flexibility of period.--The Secretary 
                may, in describing periods under paragraph 
                (2)(B), have different periods for different 
                covered persons to address different 
                logistical, practical or other differences in 
                responsibilities.
                    (B) Additional time to be specified.--In 
                each declaration under paragraph (1), the 
                Secretary, after consulting, to the extent the 
                Secretary deems appropriate, with the 
                manufacturer of the covered countermeasure, 
                shall also specify a date that is after the 
                ending date specified under paragraph (2)(B) 
                and that allows what the Secretary determines 
                is--
                            (i) a reasonable period for the 
                        manufacturer to arrange for disposition 
                        of the covered countermeasure, 
                        including the return of such product to 
                        the manufacturer; and
                            (ii) a reasonable period for 
                        covered persons to take such other 
                        actions as may be appropriate to limit 
                        administration or use of the covered 
                        countermeasure.
                    (C) Additional period for certain strategic 
                national stockpile countermeasures.--With 
                respect to a covered countermeasure that is in 
                the stockpile under section 319F-2, if such 
                countermeasure was the subject of a declaration 
                under paragraph (1) at the time that it was 
                obtained for the stockpile, the effective 
                period of such declaration shall include a 
                period when the countermeasure is administered 
                or used pursuant to a distribution or release 
                from the stockpile.
            (4) Amendments to declaration.--The Secretary may 
        through publication in the Federal Register amend any 
        portion of a declaration under paragraph (1). Such an 
        amendment shall not retroactively limit the 
        applicability of subsection (a) with respect to the 
        administration or use of the covered countermeasure 
        involved.
            (5) Certain disclosures.--In publishing a 
        declaration under paragraph (1) in the Federal 
        Register, the Secretary is not required to disclose any 
        matter described in section 552(b) of title 5, United 
        States Code.
            (6) Factors to be considered.--In deciding whether 
        and under what circumstances or conditions to issue a 
        declaration under paragraph (1) with respect to a 
        covered countermeasure, the Secretary shall consider 
        the desirability of encouraging the design, 
        development, clinical testing or investigation, 
        manufacture, labeling, distribution, formulation, 
        packaging, marketing, promotion, sale, purchase, 
        donation, dispensing, prescribing, administration, 
        licensing, and use of such countermeasure.
            (7) Judicial review.--No court of the United 
        States, or of any State, shall have subject matter 
        jurisdiction to review, whether by mandamus or 
        otherwise, any action by the Secretary under this 
        subsection.
            (8) Preemption of state law.--During the effective 
        period of a declaration under subsection (b), or at any 
        time with respect to conduct undertaken in accordance 
        with such declaration, no State or political 
        subdivision of a State may establish, enforce, or 
        continue in effect with respect to a covered 
        countermeasure any provision of law or legal 
        requirement that--
                    (A) is different from, or is in conflict 
                with, any requirement applicable under this 
                section; and
                    (B) relates to the design, development, 
                clinical testing or investigation, formulation, 
                manufacture, distribution, sale, donation, 
                purchase, marketing, promotion, packaging, 
                labeling, licensing, use, any other aspect of 
                safety or efficacy, or the prescribing, 
                dispensing, or administration by qualified 
                persons of the covered countermeasure, or to 
                any matter included in a requirement applicable 
                to the covered countermeasure under this 
                section or any other provision of this Act, or 
                under the Federal Food, Drug, and Cosmetic Act.
            (9) Report to congress.--Within 30 days after 
        making a declaration under paragraph (1), the Secretary 
        shall submit to the appropriate committees of the 
        Congress a report that provides an explanation of the 
        reasons for issuing the declaration and the reasons 
        underlying the determinations of the Secretary with 
        respect to paragraph (2). Within 30 days after making 
        an amendment under paragraph (4), the Secretary shall 
        submit to such committees a report that provides the 
        reasons underlying the determination of the Secretary 
        to make the amendment.
    (c) Definition of Willful Misconduct.--
            (1) Definition.--
                    (A) In general.--Except as the meaning of 
                such term is further restricted pursuant to 
                paragraph (2), the term ``willful misconduct'' 
                shall, for purposes of subsection (d), denote 
                an act or omission that is taken--
                            (i) intentionally to achieve a 
                        wrongful purpose;
                            (ii) knowingly without legal or 
                        factual justification; and
                            (iii) in disregard of a known or 
                        obvious risk that is so great as to 
                        make it highly probable that the harm 
                        will outweigh the benefit.
                    (B) Rule of construction.--The criterion 
                stated in subparagraph (A) shall be construed 
                as establishing a standard for liability that 
                is more stringent than a standard of negligence 
                in any form or recklessness.
            (2) Authority to promulgate regulatory 
        definition.--
                    (A) In general.--The Secretary, in 
                consultation with the Attorney General, shall 
                promulgate regulations, which may be 
                promulgated through interim final rules, that 
                further restrict the scope of actions or 
                omissions by a covered person that may qualify 
                as ``willful misconduct'' for purposes of 
                subsection (d).
                    (B) Factors to be considered.--In 
                promulgating the regulations under this 
                paragraph, the Secretary, in consultation with 
                the Attorney General, shall consider the need 
                to define the scope of permissible civil 
                actions under subsection (d) in a way that will 
                not adversely affect the public health.
                    (C) Temporal scope of regulations.--The 
                regulations under this paragraph may specify 
                the temporal effect that they shall be given 
                for purposes of subsection (d).
                    (D) Initial rulemaking.--Within 180 days 
                after the enactment of the Public Readiness and 
                Emergency Preparedness Act, the Secretary, in 
                consultation with the Attorney General, shall 
                commence and complete an initial rulemaking 
                process under this paragraph.
            (3) Proof of willful misconduct.--In an action 
        under subsection (d), the plaintiff shall have the 
        burden of proving by clear and convincing evidence 
        willful misconduct by each covered person sued and that 
        such willful misconduct caused death or serious 
        physical injury.
            (4) Defense for acts or omissions taken pursuant to 
        secretary's declaration.--Notwithstanding any other 
        provision of law, a program planner or qualified person 
        shall not have engaged in ``willful misconduct'' as a 
        matter of law where such program planner or qualified 
        person acted consistent with applicable directions, 
        guidelines, or recommendations by the Secretary 
        regarding the administration or use of a covered 
        countermeasure that is specified in the declaration 
        under subsection (b), provided either the Secretary, or 
        a State or local health authority, was provided with 
        notice of information regarding serious physical injury 
        or death from the administration or use of a covered 
        countermeasure that is material to the plaintiff's 
        alleged loss within 7 days of the actual discovery of 
        such information by such program planner or qualified 
        person.
            (5) Exclusion for regulated activity of 
        manufacturer or distributor.--
                    (A) In general.--If an act or omission by a 
                manufacturer or distributor with respect to a 
                covered countermeasure, which act or omission 
                is alleged under subsection (e)(3)(A) to 
                constitute willful misconduct, is subject to 
                regulation by this Act or by the Federal Food, 
                Drug, and Cosmetic Act, such act or omission 
                shall not constitute ``willful misconduct'' for 
                purposes of subsection (d) if--
                            (i) neither the Secretary nor the 
                        Attorney General has initiated an 
                        enforcement action with respect to such 
                        act or omission; or
                            (ii) such an enforcement action has 
                        been initiated and the action has been 
                        terminated or finally resolved without 
                        a covered remedy.
                Any action or proceeding under subsection (d) 
                shall be stayed during the pendency of such an 
                enforcement action.
                    (B) Definitions.--For purposes of this 
                paragraph, the following terms have the 
                following meanings:
                            (i) Enforcement action.--The term 
                        ``enforcement action'' means a criminal 
                        prosecution, an action seeking an 
                        injunction, a seizure action, a civil 
                        monetary proceeding based on willful 
                        misconduct, a mandatory recall of a 
                        product because voluntary recall was 
                        refused, a proceeding to compel repair 
                        or replacement of a product, a 
                        termination of an exemption under 
                        section 505(i) or 520(g) of the Federal 
                        Food, Drug, and Cosmetic Act, a 
                        debarment proceeding, an investigator 
                        disqualification proceeding where an 
                        investigator is an employee or agent of 
                        the manufacturer, a revocation, based 
                        on willful misconduct, of an 
                        authorization under section 564 of such 
                        Act, or a suspension or withdrawal, 
                        based on willful misconduct, of an 
                        approval or clearance under chapter V 
                        of such Act or of a licensure under 
                        section 351 of this Act.
                            (ii) Covered remedy.--The term 
                        ``covered remedy'' means an outcome--
                                    (I) that is a criminal 
                                conviction, an injunction, or a 
                                condemnation, a civil monetary 
                                payment, a product recall, a 
                                repair or replacement of a 
                                product, a termination of an 
                                exemption under section 505(i) 
                                or 520(g) of the Federal Food, 
                                Drug, and Cosmetic Act, a 
                                debarment, an investigator 
                                disqualification, a revocation 
                                of an authorization under 
                                section 564 of such Act, or a 
                                suspension or withdrawal of an 
                                approval or clearance under 
                                chapter 5 of such Act or of a 
                                licensure under section 351 of 
                                this Act; and
                                    (II) that results from a 
                                final determination by a court 
                                or from a final agency action.
                            (iii) Final.--The terms ``final'' 
                        and ``finally''--
                                    (I) with respect to a court 
                                determination, or to a final 
                                resolution of an enforcement 
                                action that is a court 
                                determination, mean a judgment 
                                from which an appeal of right 
                                cannot be taken or a voluntary 
                                or stipulated dismissal; and
                                    (II) with respect to an 
                                agency action, or to a final 
                                resolution of an enforcement 
                                action that is an agency 
                                action, mean an order that is 
                                not subject to further review 
                                within the agency and that has 
                                not been reversed, vacated, 
                                enjoined, or otherwise 
                                nullified by a final court 
                                determination or a voluntary or 
                                stipulated dismissal.
                    (C) Rules of construction.--
                            (i) In general.--Nothing in this 
                        paragraph shall be construed--
                                    (I) to affect the 
                                interpretation of any provision 
                                of the Federal Food, Drug, and 
                                Cosmetic Act, of this Act, or 
                                of any other applicable statute 
                                or regulation; or
                                    (II) to impair, delay, 
                                alter, or affect the authority, 
                                including the enforcement 
                                discretion, of the United 
                                States, of the Secretary, of 
                                the Attorney General, or of any 
                                other official with respect to 
                                any administrative or court 
                                proceeding under this Act, 
                                under the Federal Food, Drug, 
                                and Cosmetic Act, under title 
                                18 of the United States Code, 
                                or under any other applicable 
                                statute or regulation.
                            (ii) Mandatory recalls.--A 
                        mandatory recall called for in the 
                        declaration is not a Food and Drug 
                        Administration enforcement action.
    (d) Exception to Immunity of Covered Persons.--
            (1) In general.--Subject to subsection (f), the 
        sole exception to the immunity from suit and liability 
        of covered persons set forth in subsection (a) shall be 
        for an exclusive Federal cause of action against a 
        covered person for death or serious physical injury 
        proximately caused by willful misconduct, as defined 
        pursuant to subsection (c), by such covered person. For 
        purposes of section 2679(b)(2)(B) of title 28, United 
        States Code, such a cause of action is not an action 
        brought for violation of a statute of the United States 
        under which an action against an individual is 
        otherwise authorized.
            (2) Persons who can sue.--An action under this 
        subsection may be brought for wrongful death or serious 
        physical injury by any person who suffers such injury 
        or by any representative of such a person.
    (e) Procedures for Suit.--
            (1) Exclusive federal jurisdiction.--Any action 
        under subsection (d) shall be filed and maintained only 
        in the United States District Court for the District of 
        Columbia.
            (2) Governing law.--The substantive law for 
        decision in an action under subsection (d) shall be 
        derived from the law, including choice of law 
        principles, of the State in which the alleged willful 
        misconduct occurred, unless such law is inconsistent 
        with or preempted by Federal law, including provisions 
        of this section.
            (3) Pleading with particularity.--In an action 
        under subsection (d), the complaint shall plead with 
        particularity each element of the plaintiff's claim, 
        including--
                    (A) each act or omission, by each covered 
                person sued, that is alleged to constitute 
                willful misconduct relating to the covered 
                countermeasure administered to or used by the 
                person on whose behalf the complaint was filed;
                    (B) facts supporting the allegation that 
                such alleged willful misconduct proximately 
                caused the injury claimed; and
                    (C) facts supporting the allegation that 
                the person on whose behalf the complaint was 
                filed suffered death or serious physical 
                injury.
            (4) Verification, certification, and medical 
        records.--
                    (A) In general.--In an action under 
                subsection (d), the plaintiff shall verify the 
                complaint in the manner stated in subparagraph 
                (B) and shall file with the complaint the 
                materials described in subparagraph (C). A 
                complaint that does not substantially comply 
                with subparagraphs (B) and (C) shall not be 
                accepted for filing and shall not stop the 
                running of the statute of limitations.
                    (B) Verification requirement.--
                            (i) In general.--The complaint 
                        shall include a verification, made by 
                        affidavit of the plaintiff under oath, 
                        stating that the pleading is true to 
                        the knowledge of the deponent, except 
                        as to matters specifically identified 
                        as being alleged on information and 
                        belief, and that as to those matters 
                        the plaintiff believes it to be true.
                            (ii) Identification of matters 
                        alleged upon information and belief.--
                        Any matter that is not specifically 
                        identified as being alleged upon the 
                        information and belief of the 
                        plaintiff, shall be regarded for all 
                        purposes, including a criminal 
                        prosecution, as having been made upon 
                        the knowledge of the plaintiff.
                    (C) Materials required.--In an action under 
                subsection (d), the plaintiff shall file with 
                the complaint--
                            (i) an affidavit, by a physician 
                        who did not treat the person on whose 
                        behalf the complaint was filed, 
                        certifying, and explaining the basis 
                        for such physician's belief, that such 
                        person suffered the serious physical 
                        injury or death alleged in the 
                        complaint and that such injury or death 
                        was proximately caused by the 
                        administration or use of a covered 
                        countermeasure; and
                            (ii) certified medical records 
                        documenting such injury or death and 
                        such proximate causal connection.
            (5) Three-judge court.--Any action under subsection 
        (d) shall be assigned initially to a panel of three 
        judges. Such panel shall have jurisdiction over such 
        action for purposes of considering motions to dismiss, 
        motions for summary judgment, and matters related 
        thereto. If such panel has denied such motions, or if 
        the time for filing such motions has expired, such 
        panel shall refer the action to the chief judge for 
        assignment for further proceedings, including any 
        trial. Section 1253 of title 28, United States Code, 
        and paragraph (3) of subsection (b) of section 2284 of 
        title 28, United States Code, shall not apply to 
        actions under subsection (d).
            (6) Civil discovery.--
                    (A) Timing.--In an action under subsection 
                (d), no discovery shall be allowed--
                            (i) before each covered person sued 
                        has had a reasonable opportunity to 
                        file a motion to dismiss;
                            (ii) in the event such a motion is 
                        filed, before the court has ruled on 
                        such motion; and
                            (iii) in the event a covered person 
                        files an interlocutory appeal from the 
                        denial of such a motion, before the 
                        court of appeals has ruled on such 
                        appeal.
                    (B) Standard.--Notwithstanding any other 
                provision of law, the court in an action under 
                subsection (d) shall permit discovery only with 
                respect to matters directly related to material 
                issues contested in such action, and the court 
                shall compel a response to a discovery request 
                (including a request for admission, an 
                interrogatory, a request for production of 
                documents, or any other form of discovery 
                request) under Rule 37, Federal Rules of Civil 
                Procedure, only if the court finds that the 
                requesting party needs the information sought 
                to prove or defend as to a material issue 
                contested in such action and that the likely 
                benefits of a response to such request equal or 
                exceed the burden or cost for the responding 
                party of providing such response.
            (7) Reduction in award of damages for collateral 
        source benefits.--
                    (A) In general.--In an action under 
                subsection (d), the amount of an award of 
                damages that would otherwise be made to a 
                plaintiff shall be reduced by the amount of 
                collateral source benefits to such plaintiff.
                    (B) Provider of collateral source benefits 
                not to have lien or subrogation.--No provider 
                of collateral source benefits shall recover any 
                amount against the plaintiff or receive any 
                lien or credit against the plaintiff's recovery 
                or be equitably or legally subrogated to the 
                right of the plaintiff in an action under 
                subsection (d).
                    (C) Collateral source benefit defined.--For 
                purposes of this paragraph, the term 
                ``collateral source benefit'' means any amount 
                paid or to be paid in the future to or on 
                behalf of the plaintiff, or any service, 
                product, or other benefit provided or to be 
                provided in the future to or on behalf of the 
                plaintiff, as a result of the injury or 
                wrongful death, pursuant to--
                            (i) any State or Federal health, 
                        sickness, income-disability, accident, 
                        or workers' compensation law;
                            (ii) any health, sickness, income-
                        disability, or accident insurance that 
                        provides health benefits or income-
                        disability coverage;
                            (iii) any contract or agreement of 
                        any group, organization, partnership, 
                        or corporation to provide, pay for, or 
                        reimburse the cost of medical, 
                        hospital, dental, or income disability 
                        benefits; or
                            (iv) any other publicly or 
                        privately funded program.
            (8) Noneconomic damages.--In an action under 
        subsection (d), any noneconomic damages may be awarded 
        only in an amount directly proportional to the 
        percentage of responsibility of a defendant for the 
        harm to the plaintiff. For purposes of this paragraph, 
        the term ``noneconomic damages'' means damages for 
        losses for physical and emotional pain, suffering, 
        inconvenience, physical impairment, mental anguish, 
        disfigurement, loss of enjoyment of life, loss of 
        society and companionship, loss of consortium, hedonic 
        damages, injury to reputation, and any other 
        nonpecuniary losses.
            (9) Rule 11 sanctions.--Whenever a district court 
        of the United States determines that there has been a 
        violation of Rule 11 of the Federal Rules of Civil 
        Procedure in an action under subsection (d), the court 
        shall impose upon the attorney, law firm, or parties 
        that have violated Rule 11 or are responsible for the 
        violation, an appropriate sanction, which may include 
        an order to pay the other party or parties for the 
        reasonable expenses incurred as a direct result of the 
        filing of the pleading, motion, or other paper that is 
        the subject of the violation, including a reasonable 
        attorney's fee. Such sanction shall be sufficient to 
        deter repetition of such conduct or comparable conduct 
        by others similarly situated, and to compensate the 
        party or parties injured by such conduct.
            (10) Interlocutory appeal.--The United States Court 
        of Appeals for the District of Columbia Circuit shall 
        have jurisdiction of an interlocutory appeal by a 
        covered person taken within 30 days of an order denying 
        a motion to dismiss or a motion for summary judgment 
        based on an assertion of the immunity from suit 
        conferred by subsection (a) or based on an assertion of 
        the exclusion under subsection (c)(5).
    (f) Actions by and Against the United States.--Nothing in 
this section shall be construed to abrogate or limit any right, 
remedy, or authority that the United States or any agency 
thereof may possess under any other provision of law or to 
waive sovereign immunity or to abrogate or limit any defense or 
protection available to the United States or its agencies, 
instrumentalities, officers, or employees under any other law, 
including any provision of chapter 171 of title 28, United 
States Code (relating to tort claims procedure).
    (g) Severability.--If any provision of this section, or the 
application of such provision to any person or circumstance, is 
held to be unconstitutional, the remainder of this section and 
the application of such remainder to any person or circumstance 
shall not be affected thereby.
    (h) Rule of Construction Concerning National Vaccine Injury 
Compensation Program.--Nothing in this section, or any 
amendment made by the Public Readiness and Emergency 
Preparedness Act, shall be construed to affect the National 
Vaccine Injury Compensation Program under title XXI of this 
Act.
    (i) Definitions.--In this section:
            (1) Covered countermeasure.--The term ``covered 
        countermeasure'' means--
                    (A) a qualified pandemic or epidemic 
                product (as defined in paragraph (7));
                    (B) a security countermeasure (as defined 
                in section 319F-2(c)(1)(B)); or
                    (C) a drug (as such term is defined in 
                section 201(g)(1) of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 321(g)(1)), 
                biological product (as such term is defined by 
                section 351(i) of this Act), or device (as such 
                term is defined by section 201(h) of the 
                Federal Food, Drug and Cosmetic Act (21 U.S.C. 
                321(h)) that is authorized for emergency use in 
                accordance with section 564 of the Federal 
                Food, Drug, and Cosmetic Act.
            (2) Covered person.--The term ``covered person'', 
        when used with respect to the administration or use of 
        a covered countermeasure, means--
                    (A) the United States; or
                    (B) a person or entity that is--
                            (i) a manufacturer of such 
                        countermeasure;
                            (ii) a distributor of such 
                        countermeasure;
                            (iii) a program planner of such 
                        countermeasure;
                            (iv) a qualified person who 
                        prescribed, administered, or dispensed 
                        such countermeasure; or
                            (v) an official, agent, or employee 
                        of a person or entity described in 
                        clause (i), (ii), (iii), or (iv).
            (3) Distributor.--The term ``distributor'' means a 
        person or entity engaged in the distribution of drugs, 
        biologics, or devices, including but not limited to 
        manufacturers; repackers; common carriers; contract 
        carriers; air carriers; own-label distributors; 
        private-label distributors; jobbers; brokers; 
        warehouses, and wholesale drug warehouses; independent 
        wholesale drug traders; and retail pharmacies.
            (4) Manufacturer.--The term ``manufacturer'' 
        includes--
                    (A) a contractor or subcontractor of a 
                manufacturer;
                    (B) a supplier or licenser of any product, 
                intellectual property, service, research tool, 
                or component or other article used in the 
                design, development, clinical testing, 
                investigation, or manufacturing of a covered 
                countermeasure; and
                    (C) any or all of the parents, 
                subsidiaries, affiliates, successors, and 
                assigns of a manufacturer.
            (5) Person.--The term ``person'' includes an 
        individual, partnership, corporation, association, 
        entity, or public or private corporation, including a 
        Federal, State, or local government agency or 
        department.
            (6) Program planner.--The term ``program planner'' 
        means a State or local government, including an Indian 
        tribe, a person employed by the State or local 
        government, or other person who supervised or 
        administered a program with respect to the 
        administration, dispensing, distribution, provision, or 
        use of a security countermeasure or a qualified 
        pandemic or epidemic product, including a person who 
        has established requirements, provided policy guidance, 
        or supplied technical or scientific advice or 
        assistance or provides a facility to administer or use 
        a covered countermeasure in accordance with a 
        declaration under subsection (b).
            (7) Qualified pandemic or epidemic product.--The 
        term ``qualified pandemic or epidemic product'' means a 
        drug (as such term is defined in section 201(g)(1) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        321(g)(1)), biological product (as such term is defined 
        by section 351(i) of this Act), or device (as such term 
        is defined by section 201(h) of the Federal Food, Drug 
        and Cosmetic Act (21 U.S.C. 321(h)) that is--
                    (A)(i) a product manufactured, used, 
                designed, developed, modified, licensed, or 
                procured--
                            (I) to diagnose, mitigate, prevent, 
                        treat, or cure a pandemic or epidemic; 
                        or
                            (II) to limit the harm such 
                        pandemic or epidemic might otherwise 
                        cause; or
                    (ii) a product manufactured, used, 
                designed, developed, modified, licensed, or 
                procured to diagnose, mitigate, prevent, treat, 
                or cure a serious or life-threatening disease 
                or condition caused by a product described in 
                clause (i); and
                    (B)(i) approved or cleared under chapter V 
                of the Federal Food, Drug, and Cosmetic Act or 
                licensed under section 351 of this Act;
                    (ii) the object of research for possible 
                use as described by subparagraph (A) and is the 
                subject of an exemption under section 505(i) or 
                520(g) of the Federal Food, Drug, and Cosmetic 
                Act; or
                    (iii) authorized for emergency use in 
                accordance with section 564 of the Federal 
                Food, Drug, and Cosmetic Act.
            (8) Qualified person.--The term ``qualified 
        person'', when used with respect to the administration 
        or use of a covered countermeasure, means--
                    (A) a licensed health professional or other 
                individual who is authorized to prescribe, 
                administer, or dispense such countermeasures 
                under the law of the State in which the 
                countermeasure was prescribed, administered, or 
                dispensed; or
                    (B) a person within a category of persons 
                so identified in a declaration by the Secretary 
                under subsection (b).
            (9) Security countermeasure.--The term ``security 
        countermeasure'' has the meaning given such term in 
        section 319F-2(c)(1)(B).
            (10) Serious physical injury.--The term ``serious 
        physical injury'' means an injury that--
                    (A) is life threatening;
                    (B) results in permanent impairment of a 
                body function or permanent damage to a body 
                structure; or
                    (C) necessitates medical or surgical 
                intervention to preclude permanent impairment 
                of a body function or permanent damage to a 
                body structure.

SEC. 319F-4. [247D-6E] COVERED COUNTERMEASURE PROCESS.

    (a) Establishment of Fund.--Upon the issuance by the 
Secretary of a declaration under section 319F-3(b), there is 
hereby established in the Treasury an emergency fund designated 
as the ``Covered Countermeasure Process Fund'' for purposes of 
providing timely, uniform, and adequate compensation to 
eligible individuals for covered injuries directly caused by 
the administration or use of a covered countermeasure pursuant 
to such declaration, which Fund shall consist of such amounts 
designated as emergency appropriations under section 402 of H. 
Con. Res. 95 of the 109th Congress, this emergency designation 
shall remain in effect through October 1, 2006.
    (b) Payment of Compensation.--
            (1) In general.--If the Secretary issues a 
        declaration under 319F-3(b), the Secretary shall, after 
        amounts have by law been provided for the Fund under 
        subsection (a), provide compensation to an eligible 
        individual for a covered injury directly caused by the 
        administration or use of a covered countermeasure 
        pursuant to such declaration.
            (2) Elements of compensation.--The compensation 
        that shall be provided pursuant to paragraph (1) shall 
        have the same elements, and be in the same amount, as 
        is prescribed by sections 264, 265, and 266 in the case 
        of certain individuals injured as a result of 
        administration of certain countermeasures against 
        smallpox, except that section 266(a)(2)(B) shall not 
        apply.
            (3) Rule of construction.--Neither reasonable and 
        necessary medical benefits nor lifetime total benefits 
        for lost employment income due to permanent and total 
        disability shall be limited by section 266.
            (4) Determination of eligibility and 
        compensation.--Except as provided in this section, the 
        procedures for determining, and for reviewing a 
        determination of, whether an individual is an eligible 
        individual, whether such individual has sustained a 
        covered injury, whether compensation may be available 
        under this section, and the amount of such compensation 
        shall be those stated in section 262 (other than in 
        subsection (d)(2) of such section), in regulations 
        issued pursuant to that section, and in such additional 
        or alternate regulations as the Secretary may 
        promulgate for purposes of this section. In making 
        determinations under this section, other than those 
        described in paragraph (5)(A) as to the direct 
        causation of a covered injury, the Secretary may only 
        make such determination based on compelling, reliable, 
        valid, medical and scientific evidence.
            (5) Covered countermeasure injury table.--
                    (A) In general.--The Secretary shall by 
                regulation establish a table identifying 
                covered injuries that shall be presumed to be 
                directly caused by the administration or use of 
                a covered countermeasure and the time period in 
                which the first symptom or manifestation of 
                onset of each such adverse effect must manifest 
                in order for such presumption to apply. The 
                Secretary may only identify such covered 
                injuries, for purpose of inclusion on the 
                table, where the Secretary determines, based on 
                compelling, reliable, valid, medical and 
                scientific evidence that administration or use 
                of the covered countermeasure directly caused 
                such covered injury.
                    (B) Amendments.--The provisions of section 
                263 (other than a provision of subsection 
                (a)(2) of such section that relates to 
                accidental vaccinia inoculation) shall apply to 
                the table established under this section.
                    (C) Judicial review.--No court of the 
                United States, or of any State, shall have 
                subject matter jurisdiction to review, whether 
                by mandamus or otherwise, any action by the 
                Secretary under this paragraph.
            (6) Meanings of terms.--In applying sections 262, 
        263, 264, 265, and 266 for purposes of this section--
                    (A) the terms ``vaccine'' and ``smallpox 
                vaccine'' shall be deemed to mean a covered 
                countermeasure;
                    (B) the terms ``smallpox vaccine injury 
                table'' and ``table established under section 
                263'' shall be deemed to refer to the table 
                established under paragraph (4); and
                    (C) other terms used in those sections 
                shall have the meanings given to such terms by 
                this section.
    (c) Voluntary Program.--The Secretary shall ensure that a 
State, local, or Department of Health and Human Services plan 
to administer or use a covered countermeasure is consistent 
with any declaration under 319F-3 and any applicable guidelines 
of the Centers for Disease Control and Prevention and that 
potential participants are educated with respect to 
contraindications, the voluntary nature of the program, and the 
availability of potential benefits and compensation under this 
part.
    (d) Exhaustion; Exclusivity; Election.--
            (1) Exhaustion.--Subject to paragraph (5), a 
        covered individual may not bring a civil action under 
        section 319F-3(d) against a covered person (as such 
        term is defined in section 319F-3(i)(2)) unless such 
        individual has exhausted such remedies as are available 
        under subsection (a), except that if amounts have not 
        by law been provided for the Fund under subsection (a), 
        or if the Secretary fails to make a final determination 
        on a request for benefits or compensation filed in 
        accordance with the requirements of this section within 
        240 days after such request was filed, the individual 
        may seek any remedy that may be available under section 
        319F-3(d).
            (2) Tolling of statute of limitations.--The time 
        limit for filing a civil action under section 319F-3(d) 
        for an injury or death shall be tolled during the 
        pendency of a claim for compensation under subsection 
        (a).
            (3) Rule of construction.--This section shall not 
        be construed as superseding or otherwise affecting the 
        application of a requirement, under chapter 171 of 
        title 28, United States Code, to exhaust administrative 
        remedies.
            (4) Exclusivity.--The remedy provided by subsection 
        (a) shall be exclusive of any other civil action or 
        proceeding for any claim or suit this section 
        encompasses, except for a proceeding under section 
        319F-3.
            (5) Election.--If under subsection (a) the 
        Secretary determines that a covered individual 
        qualifies for compensation, the individual has an 
        election to accept the compensation or to bring an 
        action under section 319F-3(d). If such individual 
        elects to accept the compensation, the individual may 
        not bring such an action.
    (e) Definitions.--For purposes of this section, the 
following terms shall have the following meanings:
            (1) Covered countermeasure.--The term ``covered 
        countermeasure'' has the meaning given such term in 
        section 319F-3.
            (2) Covered individual.--The term ``covered 
        individual'', with respect to administration or use of 
        a covered countermeasure pursuant to a declaration, 
        means an individual--
                    (A) who is in a population specified in 
                such declaration, and with respect to whom the 
                administration or use of the covered 
                countermeasure satisfies the other 
                specifications of such declaration; or
                    (B) who uses the covered countermeasure, or 
                to whom the covered countermeasure is 
                administered, in a good faith belief that the 
                individual is in the category described by 
                subparagraph (A).
            (3) Covered injury.--The term ``covered injury'' 
        means serious physical injury or death.
            (4) Declaration.--The term ``declaration'' means a 
        declaration under section 319F-3(b).
            (5) Eligible individual.--The term ``eligible 
        individual'' means an individual who is determined, in 
        accordance with subsection (b), to be a covered 
        individual who sustains a covered injury.

SEC. 319G. [247D-7] DEMONSTRATION PROGRAM TO ENHANCE BIOTERRORISM 
                    TRAINING, COORDINATION, AND READINESS.

    (a) In General.--The Secretary shall make grants to not 
more than three eligible entities to carry out demonstration 
programs to improve the detection of pathogens likely to be 
used in a bioterrorist attack, the development of plans and 
measures to respond to bioterrorist attacks, and the training 
of personnel involved with the various responsibilities and 
capabilities needed to respond to acts of bioterrorism upon the 
civilian population. Such awards shall be made on a competitive 
basis and pursuant to scientific and technical review.
    (b) Eligible Entities.--Eligible entities for grants under 
subsection (a) are States, political subdivisions of States, 
and public or private non-profit organizations.
    (c) Specific Criteria.--In making grants under subsection 
(a), the Secretary shall take into account the following 
factors:
            (1) Whether the eligible entity involved is 
        proximate to, and collaborates with, a major research 
        university with expertise in scientific training, 
        identification of biological agents, medicine, and life 
        sciences.
            (2) Whether the entity is proximate to, and 
        collaborates with, a laboratory that has expertise in 
        the identification of biological agents.
            (3) Whether the entity demonstrates, in the 
        application for the program, support and participation 
        of State and local governments and research 
        institutions in the conduct of the program.
            (4) Whether the entity is proximate to, and 
        collaborates with, or is, an academic medical center 
        that has the capacity to serve an uninsured or 
        underserved population, and is equipped to educate 
        medical personnel.
            (5) Such other factors as the Secretary determines 
        to be appropriate.
    (d) Duration of Award.--The period during which payments 
are made under a grant under subsection (a) may not exceed 5 
years. The provision of such payments shall be subject to 
annual approval by the Secretary of the payments and subject to 
the availability of appropriations for the fiscal year involved 
to make the payments.
    (e) Supplement Not Supplant.--Grants under subsection (a) 
shall be used to supplement, and not supplant, other Federal, 
State, or local public funds provided for the activities 
described in such subsection.
    (f ) General Accounting Office Report \1\.--Not later than 
180 days after the conclusion of the demonstration programs 
carried out under subsection (a), the Comptroller General of 
the United States shall submit to the Committee on Health, 
Education, Labor, and Pensions and the Committee on 
Appropriations of the Senate, and the Committee on Commerce and 
the Committee on Appropriations of the House of 
Representatives, a report that describes the ability of 
grantees under such subsection to detect pathogens likely to be 
used in a bioterrorist attack, develop plans and measures for 
dealing with such threats, and train personnel involved with 
the various responsibilities and capabilities needed to deal 
with bioterrorist threats.
---------------------------------------------------------------------------
    \1\ Now the Government Accountability Office. See section 8 of 
Public Law 108-271 (118 Stat. 814).
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    (g) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section $6,000,000 for 
fiscal year 2001, and such sums as may be necessary through 
fiscal year 2006.

SEC. 319H. [247D-7A] GRANTS REGARDING TRAINING AND EDUCATION OF CERTAIN 
                    HEALTH PROFESSIONALS.

    (a) In General.--The Secretary may make awards of grants 
and cooperative agreements to appropriate public and nonprofit 
private health or educational entities, including health 
professions schools and programs as defined in section 799B, 
for the purpose of providing low-interest loans, partial 
scholarships, partial fellowships, revolving loan funds, or 
other cost-sharing forms of assistance for the education and 
training of individuals in any category of health professions 
for which there is a shortage that the Secretary determines 
should be alleviated in order to prepare for or respond 
effectively to bioterrorism and other public health 
emergencies.
    (b) Authority Regarding Non-Federal Contributions.--The 
Secretary may require as a condition of an award under 
subsection (a) that a grantee under such subsection provide 
non-Federal contributions toward the purpose described in such 
subsection.
    (c) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2002 through 2006.

SEC. 319I. [247D-7B] EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF 
                    HEALTH PROFESSIONS VOLUNTEERS.

    (a) In General.--Not later than 12 months after the date of 
enactment of the Pandemic and All-Hazards Preparedness Act, the 
Secretary shall link existing State verification systems to 
maintain a single national interoperable network of systems, 
each system being maintained by a State or group of States, for 
the purpose of verifying the credentials and licenses of health 
care professionals who volunteer to provide health services 
during a public health emergency.
    (b) Requirements.--The interoperable network of systems 
established under subsection (a) (referred to in this section 
as the ``verification network'') shall include--
            (1) with respect to each volunteer health 
        professional included in the verification network--
                    (A) information necessary for the rapid 
                identification of, and communication with, such 
                professionals; and
                    (B) the credentials, certifications, 
                licenses, and relevant training of such 
                individuals; and
            (2) the name of each member of the Medical Reserve 
        Corps, the National Disaster Medical System, and any 
        other relevant federally-sponsored or administered 
        programs determined necessary by the Secretary.
    (c) Other Assistance.--The Secretary may make grants and 
provide technical assistance to States and other public or 
nonprofit private entities for activities relating to the 
verification network developed under subsection (a).
    (d) Accessibility.--The Secretary shall ensure that the 
verification network is electronically accessible by State, 
local, and tribal health departments and can be linked with the 
identification cards under section 2813.
    (e) Confidentiality.--The Secretary shall establish and 
require the application of and compliance with measures to 
ensure the effective security of, integrity of, and access to 
the data included in the verification network.
    (f) Coordination.--The Secretary shall coordinate with the 
Secretary of Veterans Affairs and the Secretary of Homeland 
Security to assess the feasibility of integrating the 
verification network under this section with the VetPro system 
of the Department of Veterans Affairs and the National 
Emergency Responder Credentialing System of the Department of 
Homeland Security. The Secretary shall, if feasible, integrate 
the verification network under this section with such VetPro 
system and the National Emergency Responder Credentialing 
System.
    (g) Updating of Information.--The States that are 
participants in the verification network shall, on at least a 
quarterly basis, work with the Director to provide for the 
updating of the information contained in the verification 
network.
    (h) Clarification.--Inclusion of a health professional in 
the verification network shall not constitute appointment of 
such individual as a Federal employee for any purpose, either 
under section 2812(c) or otherwise. Such appointment may only 
be made under section 2812 or 2813.
    (i) Health Care Provider Licenses.--The Secretary shall 
encourage States to establish and implement mechanisms to waive 
the application of licensing requirements applicable to health 
professionals, who are seeking to provide medical services 
(within their scope of practice), during a national, State, 
local, or tribal public health emergency upon verification that 
such health professionals are licensed and in good standing in 
another State and have not been disciplined by any State health 
licensing or disciplinary board.
    (j) Rule of Construction.--This section may not be 
construed as authorizing the Secretary to issue requirements 
regarding the provision by the States of credentials, licenses, 
accreditations, or hospital privileges.
    (k) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated $2,000,000 for fiscal year 2002, and such sums as 
may be necessary for each of the fiscal years 2003 through 
2011.

SEC. 319J. [247D-7C] SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS.

    (a) In General.--Upon the request of a recipient of an 
award under any of sections 319 through 319I or section 319K, 
the Secretary may, subject to subsection (b), provide supplies, 
equipment, and services for the purpose of aiding the recipient 
in carrying out the purposes for which the award is made and, 
for such purposes, may detail to the recipient any officer or 
employee of the Department of Health and Human Services.
    (b) Corresponding Reduction in Payments.--With respect to a 
request described in subsection (a), the Secretary shall reduce 
the amount of payments under the award involved by an amount 
equal to the costs of detailing personnel and the fair market 
value of any supplies, equipment, or services provided by the 
Secretary. The Secretary shall, for the payment of expenses 
incurred in complying with such request, expend the amounts 
withheld.

SEC. 319K. [247D-7D] SECURITY FOR COUNTERMEASURE DEVELOPMENT AND 
                    PRODUCTION.

    (a) In General.--The Secretary, in consultation with the 
Attorney General and the Secretary of Defense, may provide 
technical or other assistance to provide security to persons or 
facilities that conduct development, production, distribution, 
or storage of priority countermeasures (as defined in section 
319F(h)(4)).
    (b) Guidelines.--The Secretary may develop guidelines to 
enable entities eligible to receive assistance under subsection 
(a) to secure their facilities against potential terrorist 
attack.

SEC. 319L. [247D-7E] BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT 
                    AUTHORITY.

    (a) Definitions.--In this section:
            (1) BARDA.--The term ``BARDA'' means the Biomedical 
        Advanced Research and Development Authority.
            (2) Fund.--The term ``Fund'' means the Biodefense 
        Medical Countermeasure Development Fund established 
        under subsection (d).
            (3) Other transactions.--The term ``other 
        transactions'' means transactions, other than 
        procurement contracts, grants, and cooperative 
        agreements, such as the Secretary of Defense may enter 
        into under section 2371 of title 10, United States 
        Code.
            (4) Qualified countermeasure.--The term ``qualified 
        countermeasure'' has the meaning given such term in 
        section 319F-1.
            (5) Qualified pandemic or epidemic product.--The 
        term ``qualified pandemic or epidemic product'' has the 
        meaning given the term in section 319F-3.
            (6) Advanced research and development.--
                    (A) In general.--The term ``advanced 
                research and development'' means, with respect 
                to a product that is or may become a qualified 
                countermeasure or a qualified pandemic or 
                epidemic product, activities that 
                predominantly--
                            (i) are conducted after basic 
                        research and preclinical development of 
                        the product; and
                            (ii) are related to manufacturing 
                        the product on a commercial scale and 
                        in a form that satisfies the regulatory 
                        requirements under the Federal Food, 
                        Drug, and Cosmetic Act or under section 
                        351 of this Act.
                    (B) Activities included.--The term under 
                subparagraph (A) includes--
                            (i) testing of the product to 
                        determine whether the product may be 
                        approved, cleared, or licensed under 
                        the Federal Food, Drug, and Cosmetic 
                        Act or under section 351 of this Act 
                        for a use that is or may be the basis 
                        for such product becoming a qualified 
                        countermeasure or qualified pandemic or 
                        epidemic product, or to help obtain 
                        such approval, clearance, or license;
                            (ii) design and development of 
                        tests or models, including animal 
                        models, for such testing;
                            (iii) activities to facilitate 
                        manufacture of the product on a 
                        commercial scale with consistently high 
                        quality, as well as to improve and make 
                        available new technologies to increase 
                        manufacturing surge capacity;
                            (iv) activities to improve the 
                        shelf-life of the product or 
                        technologies for administering the 
                        product; and
                            (v) such other activities as are 
                        part of the advanced stages of testing, 
                        refinement, improvement, or preparation 
                        of the product for such use and as are 
                        specified by the Secretary.
            (7) Security countermeasure.--The term ``security 
        countermeasure'' has the meaning given such term in 
        section 319F-2.
            (8) Research tool.--The term ``research tool'' 
        means a device, technology, biological material 
        (including a cell line or an antibody), reagent, animal 
        model, computer system, computer software, or 
        analytical technique that is developed to assist in the 
        discovery, development, or manufacture of qualified 
        countermeasures or qualified pandemic or epidemic 
        products.
            (9) Program manager.--The term ``program manager'' 
        means an individual appointed to carry out functions 
        under this section and authorized to provide project 
        oversight and management of strategic initiatives.
            (10) Person.--The term ``person'' includes an 
        individual, partnership, corporation, association, 
        entity, or public or private corporation, and a 
        Federal, State, or local government agency or 
        department.
    (b) Strategic Plan for Countermeasure Research, 
Development, and Procurement.--
            (1) In general.--Not later than 6 months after the 
        date of enactment of the Pandemic and All-Hazards 
        Preparedness Act, the Secretary shall develop and make 
        public a strategic plan to integrate biodefense and 
        emerging infectious disease requirements with the 
        advanced research and development, strategic 
        initiatives for innovation, and the procurement of 
        qualified countermeasures and qualified pandemic or 
        epidemic products. The Secretary shall carry out such 
        activities as may be practicable to disseminate the 
        information contained in such plan to persons who may 
        have the capacity to substantially contribute to the 
        activities described in such strategic plan. The 
        Secretary shall update and incorporate such plan as 
        part of the National Health Security Strategy described 
        in section 2802.
            (2) Content.--The strategic plan under paragraph 
        (1) shall guide--
                    (A) research and development, conducted or 
                supported by the Department of Health and Human 
                Services, of qualified countermeasures and 
                qualified pandemic or epidemic products against 
                possible biological, chemical, radiological, 
                and nuclear agents and to emerging infectious 
                diseases;
                    (B) innovation in technologies that may 
                assist advanced research and development of 
                qualified countermeasures and qualified 
                pandemic or epidemic products (such research 
                and development referred to in this section as 
                ``countermeasure and product advanced research 
                and development''); and
                    (C) procurement of such qualified 
                countermeasures and qualified pandemic or 
                epidemic products by such Department.
    (c) Biomedical Advanced Research and Development 
Authority.--
            (1) Establishment.--There is established within the 
        Department of Health and Human Services the Biomedical 
        Advanced Research and Development Authority.
            (2) In general.--Based upon the strategic plan 
        described in subsection (b), the Secretary shall 
        coordinate the acceleration of countermeasure and 
        product advanced research and development by--
                    (A) facilitating collaboration between the 
                Department of Health and Human Services and 
                other Federal agencies, relevant industries, 
                academia, and other persons, with respect to 
                such advanced research and development;
                    (B) promoting countermeasure and product 
                advanced research and development;
                    (C) facilitating contacts between 
                interested persons and the offices or employees 
                authorized by the Secretary to advise such 
                persons regarding requirements under the 
                Federal Food, Drug, and Cosmetic Act and under 
                section 351 of this Act; and
                    (D) promoting innovation to reduce the time 
                and cost of countermeasure and product advanced 
                research and development.
            (3) Director.--The BARDA shall be headed by a 
        Director (referred to in this section as the 
        ``Director'') who shall be appointed by the Secretary 
        and to whom the Secretary shall delegate such functions 
        and authorities as necessary to implement this section.
            (4) Duties.--
                    (A) Collaboration.--To carry out the 
                purpose described in paragraph (2)(A), the 
                Secretary shall--
                            (i) facilitate and increase the 
                        expeditious and direct communication 
                        between the Department of Health and 
                        Human Services and relevant persons 
                        with respect to countermeasure and 
                        product advanced research and 
                        development, including by--
                                    (I) facilitating such 
                                communication regarding the 
                                processes for procuring such 
                                advanced research and 
                                development with respect to 
                                qualified countermeasures and 
                                qualified pandemic or epidemic 
                                products of interest; and
                                    (II) soliciting information 
                                about and data from research on 
                                potential qualified 
                                countermeasures and qualified 
                                pandemic or epidemic products 
                                and related technologies;
                            (ii) at least annually--
                                    (I) convene meetings with 
                                representatives from relevant 
                                industries, academia, other 
                                Federal agencies, international 
                                agencies as appropriate, and 
                                other interested persons;
                                    (II) sponsor opportunities 
                                to demonstrate the operation 
                                and effectiveness of relevant 
                                biodefense countermeasure 
                                technologies; and
                                    (III) convene such working 
                                groups on countermeasure and 
                                product advanced research and 
                                development as the Secretary 
                                may determine are necessary to 
                                carry out this section; and
                            (iii) carry out the activities 
                        described in section 405 of the 
                        Pandemic and All-Hazards Preparedness 
                        Act.
                    (B) Support advanced research and 
                development.--To carry out the purpose 
                described in paragraph (2)(B), the Secretary 
                shall--
                            (i) conduct ongoing searches for, 
                        and support calls for, potential 
                        qualified countermeasures and qualified 
                        pandemic or epidemic products;
                            (ii) direct and coordinate the 
                        countermeasure and product advanced 
                        research and development activities of 
                        the Department of Health and Human 
                        Services;
                            (iii) establish strategic 
                        initiatives to accelerate 
                        countermeasure and product advanced 
                        research and development and innovation 
                        in such areas as the Secretary may 
                        identify as priority unmet need areas; 
                        and
                            (iv) award contracts, grants, 
                        cooperative agreements, and enter into 
                        other transactions, for countermeasure 
                        and product advanced research and 
                        development.
                    (C) Facilitating advice.--To carry out the 
                purpose described in paragraph (2)(C) the 
                Secretary shall--
                            (i) connect interested persons with 
                        the offices or employees authorized by 
                        the Secretary to advise such persons 
                        regarding the regulatory requirements 
                        under the Federal Food, Drug, and 
                        Cosmetic Act and under section 351 of 
                        this Act related to the approval, 
                        clearance, or licensure of qualified 
                        countermeasures or qualified pandemic 
                        or epidemic products; and
                            (ii) with respect to persons 
                        performing countermeasure and product 
                        advanced research and development 
                        funded under this section, enable such 
                        offices or employees to provide to the 
                        extent practicable such advice in a 
                        manner that is ongoing and that is 
                        otherwise designed to facilitate 
                        expeditious development of qualified 
                        countermeasures and qualified pandemic 
                        or epidemic products that may achieve 
                        such approval, clearance, or licensure.
                    (D) Supporting innovation.--To carry out 
                the purpose described in paragraph (2)(D), the 
                Secretary may award contracts, grants, and 
                cooperative agreements, or enter into other 
                transactions, such as prize payments, to 
                promote--
                            (i) innovation in technologies that 
                        may assist countermeasure and product 
                        advanced research and development;
                            (ii) research on and development of 
                        research tools and other devices and 
                        technologies; and
                            (iii) research to promote strategic 
                        initiatives, such as rapid diagnostics, 
                        broad spectrum antimicrobials, and 
                        vaccine manufacturing technologies.
            (5) Transaction authorities.--
                    (A) Other transactions.--
                            (i) In general.--The Secretary 
                        shall have the authority to enter into 
                        other transactions under this 
                        subsection in the same manner as the 
                        Secretary of Defense enters into such 
                        transactions under section 2371 of 
                        title 10, United States Code.
                            (ii) Limitations on authority.--
                                    (I) In general.--
                                Subsections (b), (c), and (h) 
                                of section 845 of the National 
                                Defense Authorization Act for 
                                Fiscal Year 1994 (10 U.S.C. 
                                2371 note) shall apply to other 
                                transactions under this 
                                subparagraph as if such 
                                transactions were for prototype 
                                projects described by 
                                subsection (a) of such section 
                                845.
                                    (II) Written determinations 
                                required.--The authority of 
                                this subparagraph may be 
                                exercised for a project that is 
                                expected to cost the Department 
                                of Health and Human Services in 
                                excess of $20,000,000 only upon 
                                a written determination by the 
                                senior procurement executive 
                                for the Department (as 
                                designated for purpose of 
                                section 16(c) of the Office of 
                                Federal Procurement Policy Act 
                                (41 U.S.C. 414(c))), that the 
                                use of such authority is 
                                essential to promoting the 
                                success of the project. The 
                                authority of the senior 
                                procurement executive under 
                                this subclause may not be 
                                delegated.
                            (iii) Guidelines.--The Secretary 
                        shall establish guidelines regarding 
                        the use of the authority under clause 
                        (i). Such guidelines shall include 
                        auditing requirements.
                    (B) Expedited authorities.--
                            (i) In general.--In awarding 
                        contracts, grants, and cooperative 
                        agreements, and in entering into other 
                        transactions under subparagraph (B) or 
                        (D) of paragraph (4), the Secretary 
                        shall have the expedited procurement 
                        authorities, the authority to expedite 
                        peer review, and the authority for 
                        personal services contracts, supplied 
                        by subsections (b), (c), and (d) of 
                        section 319F-1.
                            (ii) Application of provisions.--
                        Provisions in such section 319F-1 that 
                        apply to such authorities and that 
                        require institution of internal 
                        controls, limit review, provide for 
                        Federal Tort Claims Act coverage of 
                        personal services contractors, and 
                        commit decisions to the discretion of 
                        the Secretary shall apply to the 
                        authorities as exercised pursuant to 
                        this paragraph.
                            (iii) Authority to limit 
                        competition.--For purposes of applying 
                        section 319F-1(b)(1)(D) to this 
                        paragraph, the phrase ``BioShield 
                        Program under the Project BioShield Act 
                        of 2004'' shall be deemed to mean the 
                        countermeasure and product advanced 
                        research and development program under 
                        this section.
                            (iv) Availability of data.--The 
                        Secretary shall require that, as a 
                        condition of being awarded a contract, 
                        grant, cooperative agreement, or other 
                        transaction under subparagraph (B) or 
                        (D) of paragraph (4), a person make 
                        available to the Secretary on an 
                        ongoing basis, and submit upon request 
                        to the Secretary, all data related to 
                        or resulting from countermeasure and 
                        product advanced research and 
                        development carried out pursuant to 
                        this section.
                    (C) Advance payments; advertising.--The 
                Secretary may waive the requirements of section 
                3324(a) of title 31, United States Code, or 
                section 3709 of the Revised Statutes of the 
                United States (41 U.S.C. 5) upon the 
                determination by the Secretary that such waiver 
                is necessary to obtain countermeasures or 
                products under this section.
                    (D) Milestone-based payments allowed.--In 
                awarding contracts, grants, and cooperative 
                agreements, and in entering into other 
                transactions, under this section, the Secretary 
                may use milestone-based awards and payments.
                    (E) Foreign nationals eligible.--The 
                Secretary may under this section award 
                contracts, grants, and cooperative agreements 
                to, and may enter into other transactions with, 
                highly qualified foreign national persons 
                outside the United States, alone or in 
                collaboration with American participants, when 
                such transactions may inure to the benefit of 
                the American people.
                    (F) Establishment of research centers.--The 
                Secretary may assess the feasibility and 
                appropriateness of establishing, through 
                contract, grant, cooperative agreement, or 
                other transaction, an arrangement with an 
                existing research center in order to achieve 
                the goals of this section. If such an agreement 
                is not feasible and appropriate, the Secretary 
                may establish one or more federally-funded 
                research and development centers, or 
                university-affiliated research centers, in 
                accordance with section 303(c)(3) of the 
                Federal Property and Administrative Services 
                Act of 1949 (41 U.S.C. 253(c)(3)).
            (6) At-risk individuals.--In carrying out the 
        functions under this section, the Secretary may give 
        priority to the advanced research and development of 
        qualified countermeasures and qualified pandemic or 
        epidemic products that are likely to be safe and 
        effective with respect to children, pregnant women, 
        elderly, and other at-risk individuals.
            (7) Personnel authorities.--
                    (A) Specially qualified scientific and 
                professional personnel.--
                            (i) In general.--In addition to any 
                        other personnel authorities, the 
                        Secretary may--
                                    (I) without regard to those 
                                provisions of title 5, United 
                                States Code, governing 
                                appointments in the competitive 
                                service, appoint highly 
                                qualified individuals to 
                                scientific or professional 
                                positions in BARDA, such as 
                                program managers, to carry out 
                                this section; and
                                    (II) compensate them in the 
                                same manner and subject to the 
                                same terms and conditions in 
                                which individuals appointed 
                                under section 9903 of such 
                                title are compensated, without 
                                regard to the provisions of 
                                chapter 51 and subchapter III 
                                of chapter 53 of such title 
                                relating to classification and 
                                General Schedule pay rates.
                            (ii) Manner of exercise of 
                        authority.--The authority provided for 
                        in this subparagraph shall be exercised 
                        subject to the same limitations 
                        described in section 319F-1(e)(2).
                            (iii) Term of appointment.--The 
                        term limitations described in section 
                        9903(c) of title 5, United States Code, 
                        shall apply to appointments under this 
                        subparagraph, except that the 
                        references to the ``Secretary'' and to 
                        the ``Department of Defense's national 
                        security missions'' shall be deemed to 
                        be to the Secretary of Health and Human 
                        Services and to the mission of the 
                        Department of Health and Human Services 
                        under this section.
                    (B) Special consultants.--In carrying out 
                this section, the Secretary may appoint special 
                consultants pursuant to section 207(f).
                    (C) Limitation.--
                            (i) In general.--The Secretary may 
                        hire up to 100 highly qualified 
                        individuals, or up to 50 percent of the 
                        total number of employees, whichever is 
                        less, under the authorities provided 
                        for in subparagraphs (A) and (B).
                            (ii) Report.--The Secretary shall 
                        report to Congress on a biennial basis 
                        on the implementation of this 
                        subparagraph.
    (d) Fund.--
            (1) Establishment.--There is established the 
        Biodefense Medical Countermeasure Development Fund, 
        which shall be available to carry out this section in 
        addition to such amounts as are otherwise available for 
        this purpose.
            (2) Funding.--To carry out the purposes of this 
        section, there are authorized to be appropriated to the 
        Fund--
                    (A) $1,070,000,000 for fiscal years 2006 
                through 2008, the amounts to remain available 
                until expended; and
                    (B) such sums as may be necessary for 
                subsequent fiscal years, the amounts to remain 
                available until expended.
    (e) Inapplicability of Certain Provisions.--
            (1) Disclosure.--
                    (A) In general.--The Secretary shall 
                withhold from disclosure under section 552 of 
                title 5, United States Code, specific technical 
                data or scientific information that is created 
                or obtained during the countermeasure and 
                product advanced research and development 
                carried out under subsection (c) that reveals 
                significant and not otherwise publicly known 
                vulnerabilities of existing medical or public 
                health defenses against biological, chemical, 
                nuclear, or radiological threats. Such 
                information shall be deemed to be information 
                described in section 552(b)(3) of title 5, 
                United States Code.
                    (B) Review.--Information subject to 
                nondisclosure under subparagraph (A) shall be 
                reviewed by the Secretary every 5 years, or 
                more frequently as determined necessary by the 
                Secretary, to determine the relevance or 
                necessity of continued nondisclosure.
                    (C) Sunset.--This paragraph shall cease to 
                have force or effect on the date that is 7 
                years after the date of enactment of the 
                Pandemic and All-Hazards Preparedness Act.
            (2) Review.--Notwithstanding section 14 of the 
        Federal Advisory Committee Act, a working group of 
        BARDA under this section and the National Biodefense 
        Science Board under section 319M shall each terminate 
        on the date that is 5 years after the date on which 
        each such group or Board, as applicable, was 
        established. Such 5-year period may be extended by the 
        Secretary for one or more additional 5-year periods if 
        the Secretary determines that any such extension is 
        appropriate.

SEC. 319M. [247D-F] NATIONAL BIODEFENSE SCIENCE BOARD AND WORKING 
                    GROUPS.

    (a) In General.--
            (1) Establishment and function.--The Secretary 
        shall establish the National Biodefense Science Board 
        (referred to in this section as the ``Board'') to 
        provide expert advice and guidance to the Secretary on 
        scientific, technical and other matters of special 
        interest to the Department of Health and Human Services 
        regarding current and future chemical, biological, 
        nuclear, and radiological agents, whether naturally 
        occurring, accidental, or deliberate.
            (2) Membership.--The membership of the Board shall 
        be comprised of individuals who represent the Nation's 
        preeminent scientific, public health, and medical 
        experts, as follows--
                    (A) such Federal officials as the Secretary 
                may determine are necessary to support the 
                functions of the Board;
                    (B) four individuals representing the 
                pharmaceutical, biotechnology, and device 
                industries;
                    (C) four individuals representing academia; 
                and
                    (D) five other members as determined 
                appropriate by the Secretary, of whom--
                            (i) one such member shall be a 
                        practicing healthcare professional; and
                            (ii) one such member shall be an 
                        individual from an organization 
                        representing healthcare consumers.
            (3) Term of appointment.--A member of the Board 
        described in subparagraph (B), (C), or (D) of paragraph 
        (2) shall serve for a term of 3 years, except that the 
        Secretary may adjust the terms of the initial Board 
        appointees in order to provide for a staggered term of 
        appointment for all members.
            (4) Consecutive appointments; maximum terms.--A 
        member may be appointed to serve not more than 3 terms 
        on the Board and may serve not more than 2 consecutive 
        terms.
            (5) Duties.--The Board shall--
                    (A) advise the Secretary on current and 
                future trends, challenges, and opportunities 
                presented by advances in biological and life 
                sciences, biotechnology, and genetic 
                engineering with respect to threats posed by 
                naturally occurring infectious diseases and 
                chemical, biological, radiological, and nuclear 
                agents;
                    (B) at the request of the Secretary, review 
                and consider any information and findings 
                received from the working groups established 
                under subsection (b); and
                    (C) at the request of the Secretary, 
                provide recommendations and findings for 
                expanded, intensified, and coordinated 
                biodefense research and development activities.
            (6) Meetings.--
                    (A) Initial meeting.--Not later than one 
                year after the date of enactment of the 
                Pandemic and All-Hazards Preparedness Act, the 
                Secretary shall hold the first meeting of the 
                Board.
                    (B) Subsequent meetings.--The Board shall 
                meet at the call of the Secretary, but in no 
                case less than twice annually.
            (7) Vacancies.--Any vacancy in the Board shall not 
        affect its powers, but shall be filled in the same 
        manner as the original appointment.
            (8) Chairperson.--The Secretary shall appoint a 
        chairperson from among the members of the Board.
            (9) Powers.--
                    (A) Hearings.--The Board may hold such 
                hearings, sit and act at such times and places, 
                take such testimony, and receive such evidence 
                as the Board considers advisable to carry out 
                this subsection.
                    (B) Postal services.--The Board may use the 
                United States mails in the same manner and 
                under the same conditions as other departments 
                and agencies of the Federal Government.
            (10) Personnel.--
                    (A) Employees of the federal government.--A 
                member of the Board that is an employee of the 
                Federal Government may not receive additional 
                pay, allowances, or benefits by reason of the 
                member's service on the Board.
                    (B) Other members.--A member of the Board 
                that is not an employee of the Federal 
                Government may be compensated at a rate not to 
                exceed the daily equivalent of the annual rate 
                of basic pay prescribed for level IV of the 
                Executive Schedule under section 5315 of title 
                5, United States Code, for each day (including 
                travel time) during which the member is engaged 
                in the actual performance of duties as a member 
                of the Board.
                    (C) Travel expenses.--Each member of the 
                Board shall receive travel expenses, including 
                per diem in lieu of subsistence, in accordance 
                with applicable provisions under subchapter I 
                of chapter 57 of title 5, United States Code.
                    (D) Detail of government employees.--Any 
                Federal Government employee may be detailed to 
                the Board with the approval for the 
                contributing agency without reimbursement, and 
                such detail shall be without interruption or 
                loss of civil service status or privilege.
    (b) Other Working Groups.--The Secretary may establish a 
working group of experts, or may use an existing working group 
or advisory committee, to--
            (1) identify innovative research with the potential 
        to be developed as a qualified countermeasure or a 
        qualified pandemic or epidemic product;
            (2) identify accepted animal models for particular 
        diseases and conditions associated with any biological, 
        chemical, radiological, or nuclear agent, any toxin, or 
        any potential pandemic infectious disease, and identify 
        strategies to accelerate animal model and research tool 
        development and validation; and
            (3) obtain advice regarding supporting and 
        facilitating advanced research and development related 
        to qualified countermeasures and qualified pandemic or 
        epidemic products that are likely to be safe and 
        effective with respect to children, pregnant women, and 
        other vulnerable populations, and other issues 
        regarding activities under this section that affect 
        such populations.
    (c) Definitions.--Any term that is defined in section 319L 
and that is used in this section shall have the same meaning in 
this section as such term is given in section 319L.
    (d) Authorization of Appropriations.--There are authorized 
to be appropriated $1,000,000 to carry out this section for 
fiscal year 2007 and each fiscal year thereafter.

                        hansen's disease program

    Sec. 320. [247e] (a)(1) At or through the National Hansen's 
Disease Programs Center (located in the State of Louisiana), 
the Secretary shall without charge provide short-term care and 
treatment, including outpatient care, for Hansen's disease and 
related complications to any person determined by the Secretary 
to be in need of such care and treatment. The Secretary may not 
at or through such Center provide long-term care for any such 
disease or complication.
    (2) The Center referred to in paragraph (1) shall conduct 
training in the diagnosis and management of Hansen's disease 
and related complications, and shall conduct and promote the 
coordination of research (including clinical research), 
investigations, demonstrations, and studies relating to the 
causes, diagnosis, treatment, control, and prevention of 
Hansen's disease and other mycobacterial diseases and 
complications related to such diseases.
    (3) Paragraph (1) is subject to section 211 of the 
Department of Health and Human Services Appropriations Act, 
1998. \1\
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    \1\ Title II of Public Law 105-78. See 111 Stat. 1477, 1489.
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    (b) In addition to the Center referred to in subsection 
(a), the Secretary may establish sites regarding persons with 
Hansen's disease. Each such site shall provide for the 
outpatient care and treatment for Hansen's disease and related 
complications to any person determined by the Secretary to be 
in need of such care and treatment.
    (c) The Secretary shall carry out subsections (a) and (b) 
acting through an agency of the Service. For purposes of the 
preceding sentence, the agency designated by the Secretary 
shall carry out both activities relating to the provision of 
health services and activities relating to the conduct of 
research.
    (d) The Secretary shall make payments to the Board of 
Health of the State of Hawaii for the care and treatment 
(including outpatient care) in its facilities of persons 
suffering from Hansen's disease at a rate determined by the 
Secretary. The rate shall be approximately equal to the 
operating cost per patient of such facilities, except that the 
rate may not exceed the comparable costs per patient with 
Hansen's disease for care and treatment provided by the Center 
referred to in subsection (a). Payments under this subsection 
are subject to the availability of appropriations for such 
purpose.
          coordinated program to improve pediatric oral health
    Sec. 320A. \2\ [247d-8] (a) In General.--The Secretary, 
acting through the Administrator of the Health Resources and 
Services Administration, shall establish a program to fund 
innovative oral health activities that improve the oral health 
of children under 6 years of age who are eligible for services 
provided under a Federal health program, to increase the 
utilization of dental services by such children, and to 
decrease the incidence of early childhood and baby bottle tooth 
decay.
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    \2\ The placement of this section in title III was carried out to 
reflect the probable intent of Congress. Section 1603 of Public Law 
106-310 (114 Stat. 1151) provided for an amendment to ``Part B of the 
Public Health Service Act'', without specifying which title of this Act 
was the subject of the amendment.
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    (b) Grants.--The Secretary shall award grants to or enter 
into contracts with public or private nonprofit schools of 
dentistry or accredited dental training institutions or 
programs, community dental programs, and programs operated by 
the Indian Health Service (including federally recognized 
Indian tribes that receive medical services from the Indian 
Health Service, urban Indian health programs funded under title 
V of the Indian Health Care Improvement Act, and tribes that 
contract with the Indian Health Service pursuant to the Indian 
Self-Determination and Education Assistance Act) to enable such 
schools, institutions, and programs to develop programs of oral 
health promotion, to increase training of oral health services 
providers in accordance with State practice laws, or to 
increase the utilization of dental services by eligible 
children.
    (c) Distribution.--In awarding grants under this section, 
the Secretary shall, to the extent practicable, ensure an 
equitable national geographic distribution of the grants, 
including areas of the United States where the incidence of 
early childhood caries is highest.
    (d) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section $10,000,000 for 
each the fiscal years 2001 through 2005.

       Part C--Hospitals, Medical Examinations, and Medical Care

                               hospitals

    Sec. 321. [248] The Surgeon General, pursuant to 
regulations, shall--
            (a) Control, manage, and operate all institutions, 
        hospitals, and stations of the Service, including minor 
        repairs and maintenance, and provide for the care, 
        treatment, and hospitalization of patients, including 
        the furnishing of prosthetic and orthopedic devices; 
        and from time to time with the approval of the 
        President, select suitable sites for and establish such 
        additional institutions, hospitals, and stations in the 
        States and possessions of the United States as in his 
        judgment are necessary to enable the Service to 
        discharge its functions and duties;
            (b) Provide for the transfer of Public Health 
        Service patients, in the care of attendants where 
        necessary, between hospitals and stations operated by 
        the Service or between such hospitals and stations and 
        other hospitals and stations in which Public Health 
        Service patients may be received, and the payment of 
        expenses of such transfer;
            (c) Provide for the disposal of articles produced 
        by patients in the course of their curative treatment, 
        either by allowing the patient to retain such articles 
        or by selling them and depositing the money received 
        therefor to the credit of the appropriation from which 
        the materials for making the articles were purchased;
            (d) Provide for the disposal of money and effects, 
        in the custody of the hospitals or stations, of 
        deceased patients; and
            (e) Provide, to the extent the Surgeon General 
        determines that other public or private funds are not 
        available therefor, for the payment of expenses of 
        preparing and transporting the remains of, or the 
        payment of reasonable burial expenses for, any patient 
        dying in a hospital or station.

   care and treatment of persons under quarantine and certain other 
                                persons

    Sec. 322. [249] (a) Any person when detained in accordance 
with quarantine laws, or, at the request of the Immigration and 
Naturalization Service, any person detained by that Service, 
may be treated and cared for by the Public Health Service.
    (b) Persons not entitled to treatment and care at 
institutions, hospitals, and stations of the Service may, in 
accordance with regulations of the Surgeon General, be admitted 
thereto for temporary treatment and care in case of emergency.
    (c) Persons whose care and treatment is authorized by 
subsection (a) may, in accordance with regulations, receive 
such care and treatment at the expense of the Service from 
public or private medical or hospital facilities other than 
those of the Service, when authorized by the officer in charge 
of the station at which the application is made.

              care and treatment of federal prisoners \1\

    Sec. 323. [250] The Service shall supervise and furnish 
medical treatment and other necessary medical, psychiatric, and 
related technical and scientific services, authorized by the 
Act of May 13, 1930, as amended (U.S.C., 1940 edition, title 
18, secs. 751, 752), \2\ in penal and correctional institutions 
of the United States.
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    \1\ Title I of the Departments of Commerce, Justice, and State, the 
Judiciary, and Related Agencies Appropriations Act, 2005 (as contained 
in division B of Public Law 108-447) provided that of the amounts 
appropriated for salaries and expenses regarding the Federal Prison 
System ``the Attorney General may transfer to the Health Resources and 
Services Administration such amounts as may be necessary for direct 
expenditures by that Administration for medical relief for inmates of 
Federal penal and correctional institutions''. (See 118 Stat. 2860.) 
Similar provisions have appeared in the analogous appropriations Act of 
many prior years. See section 250a of title 42, United States Code, and 
the notes following such section.
    \2\ Now codified to section 4005 of title 18, United States Code.
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             examination and treatment of federal employees

    Sec. 324. [251] (a) The Surgeon General is authorized to 
provide at institutions, hospitals, and stations of the Service 
medical, surgical, and hospital services and supplies for 
persons entitled to treatment under the United States 
Employees' Compensation Act \3\ and extensions thereof. The 
Surgeon General may also provide for making medical 
examinations of--
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    \3\ Codified to chapter 81 of title 5, United States Code.
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            (1) employees of the Federal Government for 
        retirement purposes;
            (2) employees in Federal classified service, and 
        applicants for appointment, as requested by the Civil 
        Service Commission for the purpose of promoting health 
        and efficiency;
            (3) seamen for purposes of qualifying for 
        certificates of service; and
            (4) employees eligible for benefits under the 
        Longshoremen's and Harbor Workers' Compensation Act, as 
        amended (U.S.C. 1940 edition, title 33, chapter 18), 
        \4\ as requested by any deputy commissioner thereunder.
---------------------------------------------------------------------------
    \4\ Codification remains chapter 18 of title 33, United States 
Code.
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    (b) The Secretary is authorized to provide medical, 
surgical, and dental treatment and hospitalization and 
optometric care for Federal employees (as defined in section 
8901(1) of title 5 of the United States Code) and their 
dependents at remote medical facilities of the Public Health 
Service where such care and treatment are not otherwise 
available. Such employees and their dependents who are not 
entitled to this care and treatment under any other provision 
of law shall be charged for it at rates established by the 
Secretary to reflect the reasonable cost of providing the care 
and treatment. Any payments pursuant to the preceding sentence 
shall be credited to the applicable appropriation to the Public 
Health Service for the year in which such payments are 
received.

                         examination of aliens

    Sec. 325. [252] The Surgeon General shall provide for 
making, at places within the United States or in other 
countries, such physical and mental examinations of aliens as 
are required by the immigration laws, subject to administrative 
regulations prescribed by the Attorney General and medical 
regulations prescribed by the Surgeon General with the approval 
of the Secretary.

 services to coast guard, coast and geodetic survey, and public health 
                                service

    Sec. 326. [253] (a) Subject to regulations of the 
President--
            (1) commissioned officers, chief warrant officers, 
        warrant officers, cadets, and enlisted personnel of the 
        Regular Coast Guard on active duty, including those on 
        shore duty and those on detached duty; and Regular and 
        temporary members of the United States Coast Guard 
        Reserve when on active duty;
            (2) commissioned officers, ships' officers, and 
        members of the crews of vessels of the United States 
        Coast and Geodetic Survey on active duty including 
        those on shore duty and those on detached duty; and
            (3) commissioned officers of the Regular or Reserve 
        Corps of the Public Health Service on active duty;
shall be entitled to medical, surgical, and dental treatment 
and hospitalization by the Service. The Surgeon General may 
detail commissioned officers for duty aboard vessels of the 
Coast Guard or the Coast and Geodetic Survey.
      (b)(1) The Secretary may provide health care for an 
officer of the Regular or Reserve Corps involuntarily separated 
from the Service, and for any dependent of such officer, if--
            (A) the officer or dependent was receiving health 
        care at the expense of the Service at the time of the 
        separation; and
            (B) the Secretary finds that the officer or 
        dependent is unable to obtain appropriate insurance for 
        the conditions for which the officer or dependent was 
        receiving health care.
      (2) Health care may be provided under paragraph (1) for a 
period of not more than one year from the date of separation of 
the officer from the Service.
    (c) The Service shall provide all services referred to in 
subsection (a) required by the Coast Guard or Coast and 
Geodetic Survey and shall perform all duties prescribed by 
statute in connection with the examinations to determine 
physical or mental condition for purposes of appointment, 
enlistment, and reenlistment, promotion and retirement, and 
officers of the Service assigned to duty on Coast Guard or 
Coast and Geodetic Survey vessels may extend aid to the crews 
of American vessels engaged in deep-sea fishing.

                         interdepartmental work

    Sec. 327. [254] Nothing contained in this part shall affect 
the authority of the Service to furnish any materials, 
supplies, or equipment, or perform any work or services, 
requested in accordance with section 7 of the Act of May 21, 
1920, as amended (U.S.C., 1940 edition, title 31, sec. 686), or 
the authority of any other executive department to furnish any 
materials, supplies, or equipment, or perform any work or 
services, requested by the Department of Health, Education, and 
Welfare for the Service in accordance with that section.

            sharing of medical care facilities and resources

    Sec. 327A. [254a] (a) For purposes of this section--
            (1) the term ``specialized health resources'' means 
        health care resources (whether equipment, space, or 
        personnel) which, because of cost, limited 
        availability, or unusual nature, are either unique in 
        the health care community or are subject to maximum 
        utilization only through mutual use;
            (2) the term ``hospital'', unless otherwise 
        specified, includes (in addition to other hospitals) 
        any Federal hospital.
    (b) For the purpose of maintaining or improving the quality 
of care in Public Health Service facilities and to provide a 
professional environment therein which will help to attract and 
retain highly qualified and talented health personnel, to 
encourage mutually beneficial relationships between Public 
Health Service facilities and hospitals and other health 
facilities in the health care community, and to promote the 
full utilization of hospitals and other health facilities and 
resources, the Secretary may--
            (1) enter into agreements or arrangements with 
        schools of medicine, schools of osteopathic medicine, 
        and with other health professions schools, agencies, or 
        institutions, for such interchange or cooperative use 
        of facilities and services on a reciprocal or 
        reimbursable basis, as will be of benefit to the 
        training or research programs of the participating 
        agencies; and
            (2) enter into agreement or arrangements with 
        hospitals and other health care facilities for the 
        mutual use or the exchange of use of specialized health 
        resources, and providing for reciprocal reimbursement.
Any reimbursement pursuant to any such agreement or arrangement 
shall be based on charges covering the reasonable cost of such 
utilization, including normal depreciation and amortization 
costs of equipment. Any proceeds to the Government under this 
subsection shall be credited to the applicable appropriation of 
the Public Health Service for the year in which such proceeds 
are received.

                      Part D--Primary Health Care

                       Subpart I--Health Centers

SEC. 330. [254B] HEALTH CENTERS.

    (a) Definition of Health Center.--
            (1) In general.--For purposes of this section, the 
        term ``health center'' means an entity that serves a 
        population that is medically underserved, or a special 
        medically underserved population comprised of migratory 
        and seasonal agricultural workers, the homeless, and 
        residents of public housing, by providing, either 
        through the staff and supporting resources of the 
        center or through contracts or cooperative 
        arrangements--
                    (A) required primary health services (as 
                defined in subsection (b)(1)); and
                    (B) as may be appropriate for particular 
                centers, additional health services (as defined 
                in subsection (b)(2)) necessary for the 
                adequate support of the primary health services 
                required under subparagraph (A);
        for all residents of the area served by the center 
        (hereafter referred to in this section as the 
        ``catchment area'').
            (2) Limitation.--The requirement in paragraph (1) 
        to provide services for all residents within a 
        catchment area shall not apply in the case of a health 
        center receiving a grant only under subsection (g), 
        (h), or (i).
    (b) Definitions.--For purposes of this section:
            (1) Required primary health services.--
                    (A) In general.--The term ``required 
                primary health services'' means--
                            (i) basic health services which, 
                        for purposes of this section, shall 
                        consist of--
                                    (I) health services related 
                                to family medicine, internal 
                                medicine, pediatrics, 
                                obstetrics, or gynecology that 
                                are furnished by physicians and 
                                where appropriate, physician 
                                assistants, nurse 
                                practitioners, and nurse 
                                midwives;
                                    (II) diagnostic laboratory 
                                and radiologic services;
                                    (III) preventive health 
                                services, including--
                                            (aa) prenatal and 
                                        perinatal services;
                                            (bb) appropriate 
                                        cancer screening;
                                            (cc) well-child 
                                        services;
                                            (dd) immunizations 
                                        against vaccine-
                                        preventable diseases;
                                            (ee) screenings for 
                                        elevated blood lead 
                                        levels, communicable 
                                        diseases, and 
                                        cholesterol;
                                            (ff) pediatric eye, 
                                        ear, and dental 
                                        screenings to determine 
                                        the need for vision and 
                                        hearing correction and 
                                        dental care;
                                            (gg) voluntary 
                                        family planning 
                                        services; and
                                            (hh) preventive 
                                        dental services;
                                    (IV) emergency medical 
                                services; and
                                    (V) pharmaceutical services 
                                as may be appropriate for 
                                particular centers;
                            (ii) referrals to providers of 
                        medical services (including specialty 
                        referral when medically indicated) and 
                        other health-related services 
                        (including substance abuse and mental 
                        health services);
                            (iii) patient case management 
                        services (including counseling, 
                        referral, and follow-up services) and 
                        other services designed to assist 
                        health center patients in establishing 
                        eligibility for and gaining access to 
                        Federal, State, and local programs that 
                        provide or financially support the 
                        provision of medical, social, housing, 
                        educational, or other related services;
                            (iv) services that enable 
                        individuals to use the services of the 
                        health center (including outreach and 
                        transportation services and, if a 
                        substantial number of the individuals 
                        in the population served by a center 
                        are of limited English-speaking 
                        ability, the services of appropriate 
                        personnel fluent in the language spoken 
                        by a predominant number of such 
                        individuals); and
                            (v) education of patients and the 
                        general population served by the health 
                        center regarding the availability and 
                        proper use of health services.
                    (B) Exception.--With respect to a health 
                center that receives a grant only under 
                subsection (g), the Secretary, upon a showing 
                of good cause, shall--
                            (i) waive the requirement that the 
                        center provide all required primary 
                        health services under this paragraph; 
                        and
                            (ii) approve, as appropriate, the 
                        provision of certain required primary 
                        health services only during certain 
                        periods of the year.
            (2) Additional health services.--The term 
        ``additional health services'' means services that are 
        not included as required primary health services and 
        that are appropriate to meet the health needs of the 
        population served by the health center involved. Such 
        term may include--
                    (A) behavioral and mental health and 
                substance abuse services;
                    (B) recuperative care services;
                    (C) environmental health services, 
                including--
                            (i) the detection and alleviation 
                        of unhealthful conditions associated 
                        with--
                                    (I) water supply;
                                    (II) chemical and pesticide 
                                exposures;
                                    (III) air quality; or
                                    (IV) exposure to lead;
                            (ii) sewage treatment;
                            (iii) solid waste disposal;
                            (iv) rodent and parasitic 
                        infestation;
                            (v) field sanitation;
                            (vi) housing; and
                            (vii) other environmental factors 
                        related to health; and
                    (D) in the case of health centers receiving 
                grants under subsection (g), special 
                occupation-related health services for 
                migratory and seasonal agricultural workers, 
                including--
                            (i) screening for and control of 
                        infectious diseases, including 
                        parasitic diseases; and
                            (ii) injury prevention programs, 
                        including prevention of exposure to 
                        unsafe levels of agricultural chemicals 
                        including pesticides.
            (3) Medically underserved populations.--
                    (A) In general.--The term ``medically 
                underserved population'' means the population 
                of an urban or rural area designated by the 
                Secretary as an area with a shortage of 
                personal health services or a population group 
                designated by the Secretary as having a 
                shortage of such services.
                    (B) Criteria.--In carrying out subparagraph 
                (A), the Secretary shall prescribe criteria for 
                determining the specific shortages of personal 
                health services of an area or population group. 
                Such criteria shall--
                            (i) take into account comments 
                        received by the Secretary from the 
                        chief executive officer of a State and 
                        local officials in a State; and
                            (ii) include factors indicative of 
                        the health status of a population group 
                        or residents of an area, the ability of 
                        the residents of an area or of a 
                        population group to pay for health 
                        services and their accessibility to 
                        them, and the availability of health 
                        professionals to residents of an area 
                        or to a population group.
                    (C) Limitation.--The Secretary may not 
                designate a medically underserved population in 
                a State or terminate the designation of such a 
                population unless, prior to such designation or 
                termination, the Secretary provides reasonable 
                notice and opportunity for comment and consults 
                with--
                            (i) the chief executive officer of 
                        such State;
                            (ii) local officials in such State; 
                        and
                            (iii) the organization, if any, 
                        which represents a majority of health 
                        centers in such State.
                    (D) Permissible designation.--The Secretary 
                may designate a medically underserved 
                population that does not meet the criteria 
                established under subparagraph (B) if the chief 
                executive officer of the State in which such 
                population is located and local officials of 
                such State recommend the designation of such 
                population based on unusual local conditions 
                which are a barrier to access to or the 
                availability of personal health services.
    (c) Planning Grants.--
            (1) In general.--
                    (A) Centers.--The Secretary may make grants 
                to public and nonprofit private entities for 
                projects to plan and develop health centers 
                which will serve medically underserved 
                populations. A project for which a grant may be 
                made under this subsection may include the cost 
                of the acquisition and lease of buildings and 
                equipment (including the costs of amortizing 
                the principal of, and paying the interest on, 
                loans) and shall include--
                            (i) an assessment of the need that 
                        the population proposed to be served by 
                        the health center for which the project 
                        is undertaken has for required primary 
                        health services and additional health 
                        services;
                            (ii) the design of a health center 
                        program for such population based on 
                        such assessment;
                            (iii) efforts to secure, within the 
                        proposed catchment area of such center, 
                        financial and professional assistance 
                        and support for the project;
                            (iv) initiation and encouragement 
                        of continuing community involvement in 
                        the development and operation of the 
                        project; and
                            (v) proposed linkages between the 
                        center and other appropriate provider 
                        entities, such as health departments, 
                        local hospitals, and rural health 
                        clinics, to provide better coordinated, 
                        higher quality, and more cost-effective 
                        health care services.
                    (B) Managed care networks and plans.--The 
                Secretary may make grants to health centers 
                that receive assistance under this section to 
                enable the centers to plan and develop a 
                managed care network or plan. Such a grant may 
                only be made for such a center if--
                            (i) the center has received grants 
                        under subsection (e)(1)(A) for at least 
                        2 consecutive years preceding the year 
                        of the grant under this subparagraph or 
                        has otherwise demonstrated, as required 
                        by the Secretary, that such center has 
                        been providing primary care services 
                        for at least the 2 consecutive years 
                        immediately preceding such year; and
                            (ii) the center provides assurances 
                        satisfactory to the Secretary that the 
                        provision of such services on a prepaid 
                        basis, or under another managed care 
                        arrangement, will not result in the 
                        diminution of the level or quality of 
                        health services provided to the 
                        medically underserved population served 
                        prior to the grant under this 
                        subparagraph.
                    (C) Practice management networks.--The 
                Secretary may make grants to health centers 
                that receive assistance under this section to 
                enable the centers to plan and develop practice 
                management networks that will enable the 
                centers to--
                            (i) reduce costs associated with 
                        the provision of health care services;
                            (ii) improve access to, and 
                        availability of, health care services 
                        provided to individuals served by the 
                        centers;
                            (iii) enhance the quality and 
                        coordination of health care services; 
                        or
                            (iv) improve the health status of 
                        communities.
                    (D) Use of funds.--The activities for which 
                a grant may be made under subparagraph (B) or 
                (C) may include the purchase or lease of 
                equipment, which may include data and 
                information systems (including paying for the 
                costs of amortizing the principal of, and 
                paying the interest on, loans for equipment), 
                the provision of training and technical 
                assistance related to the provision of health 
                care services on a prepaid basis or under 
                another managed care arrangement, and other 
                activities that promote the development of 
                practice management or managed care networks 
                and plans.
            (2) Limitation.--Not more than two grants may be 
        made under this subsection for the same project, except 
        that upon a showing of good cause, the Secretary may 
        make additional grant awards.
            (3) Recognition of high poverty.--
                    (A) In general.--In making grants under 
                this subsection, the Secretary may recognize 
                the unique needs of high poverty areas.
                    (B) High poverty area defined.--For 
                purposes of subparagraph (A), the term ``high 
                poverty area'' means a catchment area which is 
                established in a manner that is consistent with 
                the factors in subsection (k)(3)(J), and the 
                poverty rate of which is greater than the 
                national average poverty rate as determined by 
                the Bureau of the Census.
    (d) Loan Guarantee Program.--
            (1) Establishment.--
                    (A) In general.--The Secretary shall 
                establish a program under which the Secretary 
                may, in accordance with this subsection and to 
                the extent that appropriations are provided in 
                advance for such program, guarantee up to 90 
                percent of the principal and interest on loans 
                made by non-Federal lenders to health centers, 
                funded under this section, for the costs of 
                developing and operating managed care networks 
                or plans described in subsection (c)(1)(B), or 
                practice management networks described in 
                subsection (c)(1)(C).
                    (B) Use of funds.--Loan funds guaranteed 
                under this subsection may be used--
                            (i) to establish reserves for the 
                        furnishing of services on a pre-paid 
                        basis;
                            (ii) for costs incurred by the 
                        center or centers, otherwise permitted 
                        under this section, as the Secretary 
                        determines are necessary to enable a 
                        center or centers to develop, operate, 
                        and own the network or plan; or
                            (iii) to refinance an existing loan 
                        (as of the date of refinancing) to the 
                        center or centers, if the Secretary 
                        determines--
                                    (I) that such refinancing 
                                will be beneficial to the 
                                health center and the Federal 
                                Government; or
                                    (II) that the center (or 
                                centers) can demonstrate an 
                                ability to repay the refinanced 
                                loan equal to or greater than 
                                the ability of the center (or 
                                centers) to repay the original 
                                loan on the date the original 
                                loan was made.
                    (C) Publication of guidance.--Prior to 
                considering an application submitted under this 
                subsection, the Secretary shall publish 
                guidelines to provide guidance on the 
                implementation of this section. The Secretary 
                shall make such guidelines available to the 
                universe of parties affected under this 
                subsection, distribute such guidelines to such 
                parties upon the request of such parties, and 
                provide a copy of such guidelines to the 
                appropriate committees of Congress.
                    (D) Provision directly to networks or 
                plans.--At the request of health centers 
                receiving assistance under this section, loan 
                guarantees provided under this paragraph may be 
                made directly to networks or plans that are at 
                least majority controlled and, as applicable, 
                at least majority owned by those health 
                centers.
                    (E) Federal credit reform.--The 
                requirements of the Federal Credit Reform Act 
                of 1990 (2 U.S.C. 661 et seq.) shall apply with 
                respect to loans refinanced under subparagraph 
                (B)(iii).
            (2) Protection of financial interests.--
                    (A) In general.--The Secretary may not 
                approve a loan guarantee for a project under 
                this subsection unless the Secretary determines 
                that--
                            (i) the terms, conditions, security 
                        (if any), and schedule and amount of 
                        repayments with respect to the loan are 
                        sufficient to protect the financial 
                        interests of the United States and are 
                        otherwise reasonable, including a 
                        determination that the rate of interest 
                        does not exceed such percent per annum 
                        on the principal obligation outstanding 
                        as the Secretary determines to be 
                        reasonable, taking into account the 
                        range of interest rates prevailing in 
                        the private market for similar loans 
                        and the risks assumed by the United 
                        States, except that the Secretary may 
                        not require as security any center 
                        asset that is, or may be, needed by the 
                        center or centers involved to provide 
                        health services;
                            (ii) the loan would not be 
                        available on reasonable terms and 
                        conditions without the guarantee under 
                        this subsection; and
                            (iii) amounts appropriated for the 
                        program under this subsection are 
                        sufficient to provide loan guarantees 
                        under this subsection.
                    (B) Recovery of payments.--
                            (i) In general.--The United States 
                        shall be entitled to recover from the 
                        applicant for a loan guarantee under 
                        this subsection the amount of any 
                        payment made pursuant to such 
                        guarantee, unless the Secretary for 
                        good cause waives such right of 
                        recovery (subject to appropriations 
                        remaining available to permit such a 
                        waiver) and, upon making any such 
                        payment, the United States shall be 
                        subrogated to all of the rights of the 
                        recipient of the payments with respect 
                        to which the guarantee was made. 
                        Amounts recovered under this clause 
                        shall be credited as reimbursements to 
                        the financing account of the program.
                            (ii) Modification of terms and 
                        conditions.--To the extent permitted by 
                        clause (iii) and subject to the 
                        requirements of section 504(e) of the 
                        Credit Reform Act of 1990 (2 U.S.C. 
                        661c(e)), any terms and conditions 
                        applicable to a loan guarantee under 
                        this subsection (including terms and 
                        conditions imposed under clause (iv)) 
                        may be modified or waived by the 
                        Secretary to the extent the Secretary 
                        determines it to be consistent with the 
                        financial interest of the United 
                        States.
                            (iii) Incontestability.--Any loan 
                        guarantee made by the Secretary under 
                        this subsection shall be 
                        incontestable--
                                    (I) in the hands of an 
                                applicant on whose behalf such 
                                guarantee is made unless the 
                                applicant engaged in fraud or 
                                misrepresentation in securing 
                                such guarantee; and
                                    (II) as to any person (or 
                                successor in interest) who 
                                makes or contracts to make a 
                                loan to such applicant in 
                                reliance thereon unless such 
                                person (or successor in 
                                interest) engaged in fraud or 
                                misrepresentation in making or 
                                contracting to make such loan.
                            (iv) Further terms and 
                        conditions.--Guarantees of loans under 
                        this subsection shall be subject to 
                        such further terms and conditions as 
                        the Secretary determines to be 
                        necessary to assure that the purposes 
                        of this section will be achieved.
            (3) Loan origination fees.--
                    (A) In general.--The Secretary shall 
                collect a loan origination fee with respect to 
                loans to be guaranteed under this subsection, 
                except as provided in subparagraph (C).
                    (B) Amount.--The amount of a loan 
                origination fee collected by the Secretary 
                under subparagraph (A) shall be equal to the 
                estimated long term cost of the loan guarantees 
                involved to the Federal Government (excluding 
                administrative costs), calculated on a net 
                present value basis, after taking into account 
                any appropriations that may be made for the 
                purpose of offsetting such costs, and in 
                accordance with the criteria used to award loan 
                guarantees under this subsection.
                    (C) Waiver.--The Secretary may waive the 
                loan origination fee for a health center 
                applicant who demonstrates to the Secretary 
                that the applicant will be unable to meet the 
                conditions of the loan if the applicant incurs 
                the additional cost of the fee.
            (4) Defaults.--
                    (A) In general.--Subject to the 
                requirements of the Credit Reform Act of 1990 
                (2 U.S.C. 661 et seq.), the Secretary may take 
                such action as may be necessary to prevent a 
                default on a loan guaranteed under this 
                subsection, including the waiver of regulatory 
                conditions, deferral of loan payments, 
                renegotiation of loans, and the expenditure of 
                funds for technical and consultative 
                assistance, for the temporary payment of the 
                interest and principal on such a loan, and for 
                other purposes. Any such expenditure made under 
                the preceding sentence on behalf of a health 
                center or centers shall be made under such 
                terms and conditions as the Secretary shall 
                prescribe, including the implementation of such 
                organizational, operational, and financial 
                reforms as the Secretary determines are 
                appropriate and the disclosure of such 
                financial or other information as the Secretary 
                may require to determine the extent of the 
                implementation of such reforms.
                    (B) Foreclosure.--The Secretary may take 
                such action, consistent with State law 
                respecting foreclosure procedures and, with 
                respect to reserves required for furnishing 
                services on a prepaid basis, subject to the 
                consent of the affected States, as the 
                Secretary determines appropriate to protect the 
                interest of the United States in the event of a 
                default on a loan guaranteed under this 
                subsection, except that the Secretary may only 
                foreclose on assets offered as security (if 
                any) in accordance with paragraph (2)(A)(i).
            (5) Limitation.--Not more than one loan guarantee 
        may be made under this subsection for the same network 
        or plan, except that upon a showing of good cause the 
        Secretary may make additional loan guarantees.
            (6) Authorization of appropriations.--There are 
        authorized to be appropriated to carry out this 
        subsection such sums as may be necessary.
    (e) Operating Grants.--
            (1) Authority.--
                    (A) In general.--The Secretary may make 
                grants for the costs of the operation of public 
                and nonprofit private health centers that 
                provide health services to medically 
                underserved populations.
                    (B) Entities that fail to meet certain 
                requirements.--The Secretary may make grants, 
                for a period of not to exceed 2 years, for the 
                costs of the operation of public and nonprofit 
                private entities which provide health services 
                to medically underserved populations but with 
                respect to which the Secretary is unable to 
                make each of the determinations required by 
                subsection (k)(3).
                    (C) Operation of networks and plans.--The 
                Secretary may make grants to health centers 
                that receive assistance under this section, or 
                at the request of the health centers, directly 
                to a network or plan (as described in 
                subparagraphs (B) and (C) of subsection (c)(1)) 
                that is at least majority controlled and, as 
                applicable, at least majority owned by such 
                health centers receiving assistance under this 
                section, for the costs associated with the 
                operation of such network or plan, including 
                the purchase or lease of equipment (including 
                the costs of amortizing the principal of, and 
                paying the interest on, loans for equipment).
            (2) Use of funds.--The costs for which a grant may 
        be made under subparagraph (A) or (B) of paragraph (1) 
        may include the costs of acquiring and leasing 
        buildings and equipment (including the costs of 
        amortizing the principal of, and paying interest on, 
        loans), and the costs of providing training related to 
        the provision of required primary health services and 
        additional health services and to the management of 
        health center programs.
            (3) Construction.--The Secretary may award grants 
        which may be used to pay the costs associated with 
        expanding and modernizing existing buildings or 
        constructing new buildings (including the costs of 
        amortizing the principal of, and paying the interest 
        on, loans) for projects approved prior to October 1, 
        1996.
            (4) Limitation.--Not more than two grants may be 
        made under subparagraph (B) of paragraph (1) for the 
        same entity.
            (5) Amount.--
                    (A) In general.--The amount of any grant 
                made in any fiscal year under subparagraphs (A) 
                and (B) of paragraph (1) to a health center 
                shall be determined by the Secretary, but may 
                not exceed the amount by which the costs of 
                operation of the center in such fiscal year 
                exceed the total of--
                            (i) State, local, and other 
                        operational funding provided to the 
                        center; and
                            (ii) the fees, premiums, and third-
                        party reimbursements, which the center 
                        may reasonably be expected to receive 
                        for its operations in such fiscal year.
                    (B) Networks and plans.--The total amount 
                of grant funds made available for any fiscal 
                year under paragraph (1)(C) and subparagraphs 
                (B) and (C) of subsection (c)(1) to a health 
                center or to a network or plan shall be 
                determined by the Secretary, but may not exceed 
                2 percent of the total amount appropriated 
                under this section for such fiscal year.
                    (C) Payments.--Payments under grants under 
                subparagraph (A) or (B) of paragraph (1) shall 
                be made in advance or by way of reimbursement 
                and in such installments as the Secretary finds 
                necessary and adjustments may be made for 
                overpayments or underpayments.
                    (D) Use of nongrant funds.--Nongrant funds 
                described in clauses (i) and (ii) of 
                subparagraph (A), including any such funds in 
                excess of those originally expected, shall be 
                used as permitted under this section, and may 
                be used for such other purposes as are not 
                specifically prohibited under this section if 
                such use furthers the objectives of the 
                project.
    (f) Infant Mortality Grants.--
            (1) In general.--The Secretary may make grants to 
        health centers for the purpose of assisting such 
        centers in--
                    (A) providing comprehensive health care and 
                support services for the reduction of--
                            (i) the incidence of infant 
                        mortality; and
                            (ii) morbidity among children who 
                        are less than 3 years of age; and
                    (B) developing and coordinating service and 
                referral arrangements between health centers 
                and other entities for the health management of 
                pregnant women and children described in 
                subparagraph (A).
            (2) Priority.--In making grants under this 
        subsection the Secretary shall give priority to health 
        centers providing services to any medically underserved 
        population among which there is a substantial incidence 
        of infant mortality or among which there is a 
        significant increase in the incidence of infant 
        mortality.
            (3) Requirements.--The Secretary may make a grant 
        under this subsection only if the health center 
        involved agrees that--
                    (A) the center will coordinate the 
                provision of services under the grant to each 
                of the recipients of the services;
                    (B) such services will be continuous for 
                each such recipient;
                    (C) the center will provide follow-up 
                services for individuals who are referred by 
                the center for services described in paragraph 
                (1);
                    (D) the grant will be expended to 
                supplement, and not supplant, the expenditures 
                of the center for primary health services 
                (including prenatal care) with respect to the 
                purpose described in this subsection; and
                    (E) the center will coordinate the 
                provision of services with other maternal and 
                child health providers operating in the 
                catchment area.
    (g) Migratory and Seasonal Agricultural Workers.--
            (1) In general.--The Secretary may award grants for 
        the purposes described in subsections (c), (e), and (f) 
        for the planning and delivery of services to a special 
        medically underserved population comprised of--
                    (A) migratory agricultural workers, 
                seasonal agricultural workers, and members of 
                the families of such migratory and seasonal 
                agricultural workers who are within a 
                designated catchment area; and
                    (B) individuals who have previously been 
                migratory agricultural workers but who no 
                longer meet the requirements of subparagraph 
                (A) of paragraph (3) because of age or 
                disability and members of the families of such 
                individuals who are within such catchment area.
            (2) Environmental concerns.--The Secretary may 
        enter into grants or contracts under this subsection 
        with public and private entities to--
                    (A) assist the States in the implementation 
                and enforcement of acceptable environmental 
                health standards, including enforcement of 
                standards for sanitation in migratory 
                agricultural worker and seasonal agricultural 
                worker labor camps, and applicable Federal and 
                State pesticide control standards; and
                    (B) conduct projects and studies to assist 
                the several States and entities which have 
                received grants or contracts under this section 
                in the assessment of problems related to camp 
                and field sanitation, exposure to unsafe levels 
                of agricultural chemicals including pesticides, 
                and other environmental health hazards to which 
                migratory agricultural workers and seasonal 
                agricultural workers, and members of their 
                families, are exposed.
            (3) Definitions.--For purposes of this subsection:
                    (A) Migratory agricultural worker.--The 
                term ``migratory agricultural worker'' means an 
                individual whose principal employment is in 
                agriculture, who has been so employed within 
                the last 24 months, and who establishes for the 
                purposes of such employment a temporary abode.
                    (B) Seasonal agricultural worker.--The term 
                ``seasonal agricultural worker'' means an 
                individual whose principal employment is in 
                agriculture on a seasonal basis and who is not 
                a migratory agricultural worker.
                    (C) Agriculture.--The term ``agriculture'' 
                means farming in all its branches, including--
                            (i) cultivation and tillage of the 
                        soil;
                            (ii) the production, cultivation, 
                        growing, and harvesting of any 
                        commodity grown on, in, or as an 
                        adjunct to or part of a commodity grown 
                        in or on, the land; and
                            (iii) any practice (including 
                        preparation and processing for market 
                        and delivery to storage or to market or 
                        to carriers for transportation to 
                        market) performed by a farmer or on a 
                        farm incident to or in conjunction with 
                        an activity described in clause (ii).
    (h) Homeless Population.--
            (1) In general.--The Secretary may award grants for 
        the purposes described in subsections (c), (e), and (f) 
        for the planning and delivery of services to a special 
        medically underserved population comprised of homeless 
        individuals, including grants for innovative programs 
        that provide outreach and comprehensive primary health 
        services to homeless children and youth and children 
        and youth at risk of homelessness.
            (2) Required services.--In addition to required 
        primary health services (as defined in subsection 
        (b)(1)), an entity that receives a grant under this 
        subsection shall be required to provide substance abuse 
        services as a condition of such grant.
            (3) Supplement not supplant requirement.--A grant 
        awarded under this subsection shall be expended to 
        supplement, and not supplant, the expenditures of the 
        health center and the value of in kind contributions 
        for the delivery of services to the population 
        described in paragraph (1).
            (4) Temporary continued provision of services to 
        certain former homeless individuals.--If any grantee 
        under this subsection has provided services described 
        in this section under the grant to a homeless 
        individual, such grantee may, notwithstanding that the 
        individual is no longer homeless as a result of 
        becoming a resident in permanent housing, expend the 
        grant to continue to provide such services to the 
        individual for not more than 12 months.
            (5) Definitions.--For purposes of this section:
                    (A) Homeless individual.--The term 
                ``homeless individual'' means an individual who 
                lacks housing (without regard to whether the 
                individual is a member of a family), including 
                an individual whose primary residence during 
                the night is a supervised public or private 
                facility that provides temporary living 
                accommodations and an individual who is a 
                resident in transitional housing.
                    (B) Substance abuse.--The term ``substance 
                abuse'' has the same meaning given such term in 
                section 534(4).
                    (C) Substance abuse services.--The term 
                ``substance abuse services'' includes 
                detoxification, risk reduction, outpatient 
                treatment, residential treatment, and 
                rehabilitation for substance abuse provided in 
                settings other than hospitals.
    (i) Residents of Public Housing.--
            (1) In general.--The Secretary may award grants for 
        the purposes described in subsections (c), (e), and (f) 
        for the planning and delivery of services to a special 
        medically underserved population comprised of residents 
        of public housing (such term, for purposes of this 
        subsection, shall have the same meaning given such term 
        in section 3(b)(1) of the United States Housing Act of 
        1937) and individuals living in areas immediately 
        accessible to such public housing.
            (2) Supplement not supplant.--A grant awarded under 
        this subsection shall be expended to supplement, and 
        not supplant, the expenditures of the health center and 
        the value of in kind contributions for the delivery of 
        services to the population described in paragraph (1).
            (3) Consultation with residents.--The Secretary may 
        not make a grant under paragraph (1) unless, with 
        respect to the residents of the public housing 
        involved, the applicant for the grant--
                    (A) has consulted with the residents in the 
                preparation of the application for the grant; 
                and
                    (B) agrees to provide for ongoing 
                consultation with the residents regarding the 
                planning and administration of the program 
                carried out with the grant.
    (j) Access Grants.--
            (1) In general.--The Secretary may award grants to 
        eligible health centers with a substantial number of 
        clients with limited English speaking proficiency to 
        provide translation, interpretation, and other such 
        services for such clients with limited English speaking 
        proficiency.
            (2) Eligible health center.--In this subsection, 
        the term ``eligible health center'' means an entity 
        that--
                    (A) is a health center as defined under 
                subsection (a);
                    (B) provides health care services for 
                clients for whom English is a second language; 
                and
                    (C) has exceptional needs with respect to 
                linguistic access or faces exceptional 
                challenges with respect to linguistic access.
            (3) Grant amount.--The amount of a grant awarded to 
        a center under this subsection shall be determined by 
        the Administrator. Such determination of such amount 
        shall be based on the number of clients for whom 
        English is a second language that is served by such 
        center, and larger grant amounts shall be awarded to 
        centers serving larger numbers of such clients.
            (4) Use of funds.--An eligible health center that 
        receives a grant under this subsection may use funds 
        received through such grant to--
                    (A) provide translation, interpretation, 
                and other such services for clients for whom 
                English is a second language, including hiring 
                professional translation and interpretation 
                services; and
                    (B) compensate bilingual or multilingual 
                staff for language assistance services provided 
                by the staff for such clients.
            (5) Application.--An eligible health center 
        desiring a grant under this subsection shall submit an 
        application to the Secretary at such time, in such 
        manner, and containing such information as the 
        Secretary may reasonably require, including--
                    (A) an estimate of the number of clients 
                that the center serves for whom English is a 
                second language;
                    (B) the ratio of the number of clients for 
                whom English is a second language to the total 
                number of clients served by the center;
                    (C) a description of any language 
                assistance services that the center proposes to 
                provide to aid clients for whom English is a 
                second language; and
                    (D) a description of the exceptional needs 
                of such center with respect to linguistic 
                access or a description of the exceptional 
                challenges faced by such center with respect to 
                linguistic access.
            (6) Authorization of appropriations.--There are 
        authorized to be appropriated to carry out this 
        subsection, in addition to any funds authorized to be 
        appropriated or appropriated for health centers under 
        any other subsection of this section, such sums as may 
        be necessary for each of fiscal years 2002 through 
        2006.
    (k) Applications.--
            (1) Submission.--No grant may be made under this 
        section unless an application therefore is submitted 
        to, and approved by, the Secretary. Such an application 
        shall be submitted in such form and manner and shall 
        contain such information as the Secretary shall 
        prescribe.
            (2) Description of need.--An application for a 
        grant under subparagraph (A) or (B) of subsection 
        (e)(1) for a health center shall include--
                    (A) a description of the need for health 
                services in the catchment area of the center;
                    (B) a demonstration by the applicant that 
                the area or the population group to be served 
                by the applicant has a shortage of personal 
                health services; and
                    (C) a demonstration that the center will be 
                located so that it will provide services to the 
                greatest number of individuals residing in the 
                catchment area or included in such population 
                group.
        Such a demonstration shall be made on the basis of the 
        criteria prescribed by the Secretary under subsection 
        (b)(3) or on any other criteria which the Secretary may 
        prescribe to determine if the area or population group 
        to be served by the applicant has a shortage of 
        personal health services. In considering an application 
        for a grant under subparagraph (A) or (B) of subsection 
        (e)(1), the Secretary may require as a condition to the 
        approval of such application an assurance that the 
        applicant will provide any health service defined under 
        paragraphs (1) and (2) of subsection (b) that the 
        Secretary finds is needed to meet specific health needs 
        of the area to be served by the applicant. Such a 
        finding shall be made in writing and a copy shall be 
        provided to the applicant.
            (3) Requirements.--Except as provided in subsection 
        (e)(1)(B), the Secretary may not approve an application 
        for a grant under subparagraph (A) or (B) of subsection 
        (e)(1) unless the Secretary determines that the entity 
        for which the application is submitted is a health 
        center (within the meaning of subsection (a)) and 
        that--
                    (A) the required primary health services of 
                the center will be available and accessible in 
                the catchment area of the center promptly, as 
                appropriate, and in a manner which assures 
                continuity;
                    (B) the center has made and will continue 
                to make every reasonable effort to establish 
                and maintain collaborative relationships with 
                other health care providers in the catchment 
                area of the center;
                    (C) the center will have an ongoing quality 
                improvement system that includes clinical 
                services and management, and that maintains the 
                confidentiality of patient records;
                    (D) the center will demonstrate its 
                financial responsibility by the use of such 
                accounting procedures and other requirements as 
                may be prescribed by the Secretary;
                    (E) the center--
                            (i)(I) has or will have a 
                        contractual or other arrangement with 
                        the agency of the State, in which it 
                        provides services, which administers or 
                        supervises the administration of a 
                        State plan approved under title XIX of 
                        the Social Security Act for the payment 
                        of all or a part of the center's costs 
                        in providing health services to persons 
                        who are eligible for medical assistance 
                        under such a State plan; and
                                    (II) \1\ has or will have a 
                                contractual or other 
                                arrangement with the State 
                                agency administering the 
                                program under title XXI of such 
                                Act (42 U.S.C. 1397aa et seq.) 
                                with respect to individuals who 
                                are State children's health 
                                insurance program 
                                beneficiaries; or
---------------------------------------------------------------------------
    \1\ Indentation is so in law. See section 101(7)(A)(i)(III) of 
Public Law 107-251 (116 Stat. 225).
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                            (ii) has made or will make every 
                        reasonable effort to enter into 
                        arrangements described in subclauses 
                        (I) and (II) of clause (i);
                    (F) the center has made or will make and 
                will continue to make every reasonable effort 
                to collect appropriate reimbursement for its 
                costs in providing health services to persons 
                who are entitled to insurance benefits under 
                title XVIII of the Social Security Act, to 
                medical assistance under a State plan approved 
                under title XIX of such Act, or to assistance 
                for medical expenses under any other public 
                assistance program or private health insurance 
                program;
                    (G) the center--
                            (i) has prepared a schedule of fees 
                        or payments for the provision of its 
                        services consistent with locally 
                        prevailing rates or charges and 
                        designed to cover its reasonable costs 
                        of operation and has prepared a 
                        corresponding schedule of discounts to 
                        be applied to the payment of such fees 
                        or payments, which discounts are 
                        adjusted on the basis of the patient's 
                        ability to pay;
                            (ii) has made and will continue to 
                        make every reasonable effort--
                                    (I) to secure from patients 
                                payment for services in 
                                accordance with such schedules; 
                                and
                                    (II) to collect 
                                reimbursement for health 
                                services to persons described 
                                in subparagraph (F) on the 
                                basis of the full amount of 
                                fees and payments for such 
                                services without application of 
                                any discount;
                            (iii)(I) will assure that no 
                        patient will be denied health care 
                        services due to an individual's 
                        inability to pay for such services; and
                            (II) will assure that any fees or 
                        payments required by the center for 
                        such services will be reduced or waived 
                        to enable the center to fulfill the 
                        assurance described in subclause (I); 
                        and
                            (iv) has submitted to the Secretary 
                        such reports as the Secretary may 
                        require to determine compliance with 
                        this subparagraph;
                    (H) the center has established a governing 
                board which except in the case of an entity 
                operated by an Indian tribe or tribal or Indian 
                organization under the Indian Self-
                Determination Act or an urban Indian 
                organization under the Indian Health Care 
                Improvement Act (25 U.S.C. 1651 et seq.)--
                            (i) is composed of individuals, a 
                        majority of whom are being served by 
                        the center and who, as a group, 
                        represent the individuals being served 
                        by the center;
                            (ii) meets at least once a month, 
                        selects the services to be provided by 
                        the center, schedules the hours during 
                        which such services will be provided, 
                        approves the center's annual budget, 
                        approves the selection of a director 
                        for the center, and, except in the case 
                        of a governing board of a public center 
                        (as defined in the second sentence of 
                        this paragraph), establishes general 
                        policies for the center; and
                            (iii) in the case of an application 
                        for a second or subsequent grant for a 
                        public center, has approved the 
                        application or if the governing body 
                        has not approved the application, the 
                        failure of the governing body to 
                        approve the application was 
                        unreasonable;
                except that, upon a showing of good cause the 
                Secretary shall waive, for the length of the 
                project period, all or part of the requirements 
                of this subparagraph in the case of a health 
                center that receives a grant pursuant to 
                subsection (g), (h), (i), or (p);
                    (I) the center has developed--
                            (i) an overall plan and budget that 
                        meets the requirements of the 
                        Secretary; and
                            (ii) an effective procedure for 
                        compiling and reporting to the 
                        Secretary such statistics and other 
                        information as the Secretary may 
                        require relating to--
                                    (I) the costs of its 
                                operations;
                                    (II) the patterns of use of 
                                its services;
                                    (III) the availability, 
                                accessibility, and 
                                acceptability of its services; 
                                and
                                    (IV) such other matters 
                                relating to operations of the 
                                applicant as the Secretary may 
                                require;
                    (J) the center will review periodically its 
                catchment area to--
                            (i) ensure that the size of such 
                        area is such that the services to be 
                        provided through the center (including 
                        any satellite) are available and 
                        accessible to the residents of the area 
                        promptly and as appropriate;
                            (ii) ensure that the boundaries of 
                        such area conform, to the extent 
                        practicable, to relevant boundaries of 
                        political subdivisions, school 
                        districts, and Federal and State health 
                        and social service programs; and
                            (iii) ensure that the boundaries of 
                        such area eliminate, to the extent 
                        possible, barriers to access to the 
                        services of the center, including 
                        barriers resulting from the area's 
                        physical characteristics, its 
                        residential patterns, its economic and 
                        social grouping, and available 
                        transportation;
                    (K) in the case of a center which serves a 
                population including a substantial proportion 
                of individuals of limited English-speaking 
                ability, the center has--
                            (i) developed a plan and made 
                        arrangements responsive to the needs of 
                        such population for providing services 
                        to the extent practicable in the 
                        language and cultural context most 
                        appropriate to such individuals; and
                            (ii) identified an individual on 
                        its staff who is fluent in both that 
                        language and in English and whose 
                        responsibilities shall include 
                        providing guidance to such individuals 
                        and to appropriate staff members with 
                        respect to cultural sensitivities and 
                        bridging linguistic and cultural 
                        differences;
                    (L) the center, has developed an ongoing 
                referral relationship with one or more 
                hospitals; and
                    (M) the center encourages persons receiving 
                or seeking health services from the center to 
                participate in any public or private (including 
                employer-offered) health programs or plans for 
                which the persons are eligible, so long as the 
                center, in complying with this subparagraph, 
                does not violate the requirements of 
                subparagraph (G)(iii)(I).
        For purposes of subparagraph (H), the term ``public 
        center'' means a health center funded (or to be funded) 
        through a grant under this section to a public agency.
            (4) Approval of new or expanded service 
        applications.--The Secretary shall approve applications 
        for grants under subparagraph (A) or (B) of subsection 
        (e)(1) for health centers which--
                    (A) have not received a previous grant 
                under such subsection; or
                    (B) have applied for such a grant to expand 
                their services;
        in such a manner that the ratio of the medically 
        underserved populations in rural areas which may be 
        expected to use the services provided by such centers 
        to the medically underserved populations in urban areas 
        which may be expected to use the services provided by 
        such centers is not less than two to three or greater 
        than three to two.
    (l) Technical Assistance.--The Secretary shall establish a 
program through which the Secretary shall provide (either 
through the Department of Health and Human Services or by grant 
or contract) technical and other assistance to eligible 
entities to assist such entities to meet the requirements of 
subsection (k)(3). Services provided through the program may 
include necessary technical and nonfinancial assistance, 
including fiscal and program management assistance, training in 
fiscal and program management, operational and administrative 
support, and the provision of information to the entities of 
the variety of resources available under this title and how 
those resources can be best used to meet the health needs of 
the communities served by the entities.
    (m) Memorandum of Agreement.--In carrying out this section, 
the Secretary may enter into a memorandum of agreement with a 
State. Such memorandum may include, where appropriate, 
provisions permitting such State to--
            (1) analyze the need for primary health services 
        for medically underserved populations within such 
        State;
            (2) assist in the planning and development of new 
        health centers;
            (3) review and comment upon annual program plans 
        and budgets of health centers, including comments upon 
        allocations of health care resources in the State;
            (4) assist health centers in the development of 
        clinical practices and fiscal and administrative 
        systems through a technical assistance plan which is 
        responsive to the requests of health centers; and
            (5) share information and data relevant to the 
        operation of new and existing health centers.
    (n) Records.--
            (1) In general.--Each entity which receives a grant 
        under subsection (e) shall establish and maintain such 
        records as the Secretary shall require.
            (2) Availability.--Each entity which is required to 
        establish and maintain records under this subsection 
        shall make such books, documents, papers, and records 
        available to the Secretary or the Comptroller General 
        of the United States, or any of their duly authorized 
        representatives, for examination, copying or mechanical 
        reproduction on or off the premises of such entity upon 
        a reasonable request therefore. The Secretary and the 
        Comptroller General of the United States, or any of 
        their duly authorized representatives, shall have the 
        authority to conduct such examination, copying, and 
        reproduction.
    (o) Delegation of Authority.--The Secretary may delegate 
the authority to administer the programs authorized by this 
section to any office, except that the authority to enter into, 
modify, or issue approvals with respect to grants or contracts 
may be delegated only within the central office of the Health 
Resources and Services Administration.
    (p) Special Consideration.--In making grants under this 
section, the Secretary shall give special consideration to the 
unique needs of sparsely populated rural areas, including 
giving priority in the awarding of grants for new health 
centers under subsections (c) and (e), and the granting of 
waivers as appropriate and permitted under subsections 
(b)(1)(B)(i) and (k)(3)(G).
    (q) Audits.--
            (1) In general.--Each entity which receives a grant 
        under this section shall provide for an independent 
        annual financial audit of any books, accounts, 
        financial records, files, and other papers and property 
        which relate to the disposition or use of the funds 
        received under such grant and such other funds received 
        by or allocated to the project for which such grant was 
        made. For purposes of assuring accurate, current, and 
        complete disclosure of the disposition or use of the 
        funds received, each such audit shall be conducted in 
        accordance with generally accepted accounting 
        principles. Each audit shall evaluate--
                    (A) the entity's implementation of the 
                guidelines established by the Secretary 
                respecting cost accounting,
                    (B) the processes used by the entity to 
                meet the financial and program reporting 
                requirements of the Secretary, and
                    (C) the billing and collection procedures 
                of the entity and the relation of the 
                procedures to its fee schedule and schedule of 
                discounts and to the availability of health 
                insurance and public programs to pay for the 
                health services it provides.
        A report of each such audit shall be filed with the 
        Secretary at such time and in such manner as the 
        Secretary may require.
            (2) Records.--Each entity which receives a grant 
        under this section shall establish and maintain such 
        records as the Secretary shall by regulation require to 
        facilitate the audit required by paragraph (1). The 
        Secretary may specify by regulation the form and manner 
        in which such records shall be established and 
        maintained.
            (3) Availability of records.--Each entity which is 
        required to establish and maintain records or to 
        provide for and audit under this subsection shall make 
        such books, documents, papers, and records available to 
        the Secretary or the Comptroller General of the United 
        States, or any of their duly authorized 
        representatives, for examination, copying or mechanical 
        reproduction on or off the premises of such entity upon 
        a reasonable request therefore. The Secretary and the 
        Comptroller General of the United States, or any of 
        their duly authorized representatives, shall have the 
        authority to conduct such examination, copying, and 
        reproduction.
            (4) Waiver.--The Secretary may, under appropriate 
        circumstances, waive the application of all or part of 
        the requirements of this subsection with respect to an 
        entity.
    (r) Authorization of Appropriations.--
            (1) General amounts for grants.--For the purpose of 
        carrying out this section, in addition to the amounts 
        authorized to be appropriated under subsection (d), 
        there is authorized to be appropriated the following:
                    (A) For fiscal year 2010, $2,988,821,592.
                    (B) For fiscal year 2011, $3,862,107,440.
                    (C) For fiscal year 2012, $4,990,553,440.
                    (D) For fiscal year 2013, $6,448,713,307.
                    (E) For fiscal year 2014, $7,332,924,155.
                    (F) For fiscal year 2015, $8,332,924,155.
                    (G) For fiscal year 2016, and each 
                subsequent fiscal year, the amount appropriated 
                for the preceding fiscal year adjusted by the 
                product of--
                            (i) one plus the average percentage 
                        increase in costs incurred per patient 
                        served; and
                            (ii) one plus the average 
                        percentage increase in the total number 
                        of patients served.
            (2) Special provisions.--
                    (A) Public centers.--The Secretary may not 
                expend in any fiscal year, for grants under 
                this section to public centers (as defined in 
                the second sentence of subsection (k)(3)) the 
                governing boards of which (as described in 
                subsection (k)(3)(H)) do not establish general 
                policies for such centers, an amount which 
                exceeds 5 percent of the amounts appropriated 
                under this section for that fiscal year. For 
                purposes of applying the preceding sentence, 
                the term ``public centers'' shall not include 
                health centers that receive grants pursuant to 
                subsection (h) or (i).
                    (B) Distribution of grants.--For fiscal 
                year 2002 and each of the following fiscal 
                years, the Secretary, in awarding grants under 
                this section, shall ensure that the proportion 
                of the amount made available under each of 
                subsections (g), (h), and (i), relative to the 
                total amount appropriated to carry out this 
                section for that fiscal year, is equal to the 
                proportion of the amount made available under 
                that subsection for fiscal year 2001, relative 
                to the total amount appropriated to carry out 
                this section for fiscal year 2001.
            (3) Funding report.--The Secretary shall annually 
        prepare and submit to the appropriate committees of 
        Congress a report concerning the distribution of funds 
        under this section that are provided to meet the health 
        care needs of medically underserved populations, 
        including the homeless, residents of public housing, 
        and migratory and seasonal agricultural workers, and 
        the appropriateness of the delivery systems involved in 
        responding to the needs of the particular populations. 
        Such report shall include an assessment of the relative 
        health care access needs of the targeted populations 
        and the rationale for any substantial changes in the 
        distribution of funds.
            (4) Rule of construction with respect to rural 
        health clinics.--
                    (A) In general.--Nothing in this section 
                shall be construed to prevent a community 
                health center from contracting with a Federally 
                certified rural health clinic (as defined in 
                section 1861(aa)(2) of the Social Security 
                Act), a low-volume hospital (as defined for 
                purposes of section 1886 of such Act), a 
                critical access hospital, a sole community 
                hospital (as defined for purposes of section 
                1886(d)(5)(D)(iii) of such Act), or a medicare-
                dependent share hospital (as defined for 
                purposes of section 1886(d)(5)(G)(iv) of such 
                Act) for the delivery of primary health care 
                services that are available at the clinic or 
                hospital to individuals who would otherwise be 
                eligible for free or reduced cost care if that 
                individual were able to obtain that care at the 
                community health center. Such services may be 
                limited in scope to those primary health care 
                services available in that clinic or hospitals.
                    (B) Assurances.--In order for a clinic or 
                hospital to receive funds under this section 
                through a contract with a community health 
                center under subparagraph (A), such clinic or 
                hospital shall establish policies to ensure--
                            (i) nondiscrimination based on the 
                        ability of a patient to pay; and
                            (ii) the establishment of a sliding 
                        fee scale for low-income patients.
    (s) Demonstration Program for Individualized Wellness 
Plans.--
            (1) In general.--The Secretary shall establish a 
        pilot program to test the impact of providing at-risk 
        populations who utilize community health centers funded 
        under this section an individualized wellness plan that 
        is designed to reduce risk factors for preventable 
        conditions as identified by a comprehensive risk-factor 
        assessment.
            (2) Agreements.--The Secretary shall enter into 
        agreements with not more than 10 community health 
        centers funded under this section to conduct activities 
        under the pilot program under paragraph (1).
            (3) Wellness plans.--
                    (A) In general.--An individualized wellness 
                plan prepared under the pilot program under 
                this subsection may include one or more of the 
                following as appropriate to the individual's 
                identified risk factors:
                            (i) Nutritional counseling.
                            (ii) A physical activity plan.
                            (iii) Alcohol and smoking cessation 
                        counseling and services.
                            (iv) Stress management.
                            (v) Dietary supplements that have 
                        health claims approved by the 
                        Secretary.
                            (vi) Compliance assistance provided 
                        by a community health center employee.
                    (B) Risk factors.--Wellness plan risk 
                factors shall include--
                            (i) weight;
                            (ii) tobacco and alcohol use;
                            (iii) exercise rates;
                            (iv) nutritional status; and
                            (v) blood pressure.
                    (C) Comparisons.--Individualized wellness 
                plans shall make comparisons between the 
                individual involved and a control group of 
                individuals with respect to the risk factors 
                described in subparagraph (B).
            (4) Authorization of appropriations.--There is 
        authorized to be appropriated to carry out this 
        subsection, such sums as may be necessary.

SEC. 330A. [254C] RURAL HEALTH CARE SERVICES OUTREACH, RURAL HEALTH 
                    NETWORK DEVELOPMENT, AND SMALL HEALTH CARE PROVIDER 
                    QUALITY IMPROVEMENT GRANT PROGRAMS.

    (a) Purpose.--The purpose of this section is to provide 
grants for expanded delivery of health care services in rural 
areas, for the planning and implementation of integrated health 
care networks in rural areas, and for the planning and 
implementation of small health care provider quality 
improvement activities.
    (b) Definitions.--
            (1) Director.--The term ``Director'' means the 
        Director specified in subsection (d).
            (2) Federally qualified health center; rural health 
        clinic.--The terms ``Federally qualified health 
        center'' and ``rural health clinic'' have the meanings 
        given the terms in section 1861(aa) of the Social 
        Security Act (42 U.S.C. 1395x(aa)).
            (3) Health professional shortage area.--The term 
        ``health professional shortage area'' means a health 
        professional shortage area designated under section 
        332.
            (4) Medically underserved community.--The term 
        ``medically underserved community'' has the meaning 
        given the term in section 799B(6).
            (5) Medically underserved population.--The term 
        ``medically underserved population'' has the meaning 
        given the term in section 330(b)(3).
    (c) Program.--The Secretary shall establish, under section 
301, a small health care provider quality improvement grant 
program.
    (d) Administration.--
            (1) Programs.--The rural health care services 
        outreach, rural health network development, and small 
        health care provider quality improvement grant programs 
        established under section 301 shall be administered by 
        the Director of the Office of Rural Health Policy of 
        the Health Resources and Services Administration, in 
        consultation with State offices of rural health or 
        other appropriate State government entities.
            (2) Grants.--
                    (A) In general.--In carrying out the 
                programs described in paragraph (1), the 
                Director may award grants under subsections 
                (e), (f), and (g) to expand access to, 
                coordinate, and improve the quality of 
                essential health care services, and enhance the 
                delivery of health care, in rural areas.
                    (B) Types of grants.--The Director may 
                award the grants--
                            (i) to promote expanded delivery of 
                        health care services in rural areas 
                        under subsection (e);
                            (ii) to provide for the planning 
                        and implementation of integrated health 
                        care networks in rural areas under 
                        subsection (f); and
                            (iii) to provide for the planning 
                        and implementation of small health care 
                        provider quality improvement activities 
                        under subsection (g).
    (e) Rural Health Care Services Outreach Grants.--
            (1) Grants.--The Director may award grants to 
        eligible entities to promote rural health care services 
        outreach by expanding the delivery of health care 
        services to include new and enhanced services in rural 
        areas. The Director may award the grants for periods of 
        not more than 3 years.
            (2) Eligibility.--To be eligible to receive a grant 
        under this subsection for a project, an entity--
                    (A) shall be a rural public or rural 
                nonprofit private entity;
                    (B) shall represent a consortium composed 
                of members--
                            (i) that include 3 or more health 
                        care providers; and
                            (ii) that may be nonprofit or for-
                        profit entities; and
                    (C) shall not previously have received a 
                grant under this subsection for the same or a 
                similar project, unless the entity is proposing 
                to expand the scope of the project or the area 
                that will be served through the project.
            (3) Applications.--To be eligible to receive a 
        grant under this subsection, an eligible entity, in 
        consultation with the appropriate State office of rural 
        health or another appropriate State entity, shall 
        prepare and submit to the Secretary an application, at 
        such time, in such manner, and containing such 
        information as the Secretary may require, including--
                    (A) a description of the project that the 
                eligible entity will carry out using the funds 
                provided under the grant;
                    (B) a description of the manner in which 
                the project funded under the grant will meet 
                the health care needs of rural underserved 
                populations in the local community or region to 
                be served;
                    (C) a description of how the local 
                community or region to be served will be 
                involved in the development and ongoing 
                operations of the project;
                    (D) a plan for sustaining the project after 
                Federal support for the project has ended;
                    (E) a description of how the project will 
                be evaluated; and
                    (F) other such information as the Secretary 
                determines to be appropriate.
    (f) Rural Health Network Development Grants.--
            (1) Grants.--
                    (A) In general.--The Director may award 
                rural health network development grants to 
                eligible entities to promote, through planning 
                and implementation, the development of 
                integrated health care networks that have 
                combined the functions of the entities 
                participating in the networks in order to--
                            (i) achieve efficiencies;
                            (ii) expand access to, coordinate, 
                        and improve the quality of essential 
                        health care services; and
                            (iii) strengthen the rural health 
                        care system as a whole.
                    (B) Grant periods.--The Director may award 
                such a rural health network development grant 
                for implementation activities for a period of 3 
                years. The Director may also award such a rural 
                health network development grant for planning 
                activities for a period of 1 year, to assist in 
                the development of an integrated health care 
                network, if the proposed participants in the 
                network do not have a history of collaborative 
                efforts and a 3-year grant would be 
                inappropriate.
            (2) Eligibility.--To be eligible to receive a grant 
        under this subsection, an entity--
                    (A) shall be a rural public or rural 
                nonprofit private entity;
                    (B) shall represent a network composed of 
                participants--
                            (i) that include 3 or more health 
                        care providers; and
                            (ii) that may be nonprofit or for-
                        profit entities; and
                    (C) shall not previously have received a 
                grant under this subsection (other than a grant 
                for planning activities) for the same or a 
                similar project.
            (3) Applications.--To be eligible to receive a 
        grant under this subsection, an eligible entity, in 
        consultation with the appropriate State office of rural 
        health or another appropriate State entity, shall 
        prepare and submit to the Secretary an application, at 
        such time, in such manner, and containing such 
        information as the Secretary may require, including--
                    (A) a description of the project that the 
                eligible entity will carry out using the funds 
                provided under the grant;
                    (B) an explanation of the reasons why 
                Federal assistance is required to carry out the 
                project;
                    (C) a description of--
                            (i) the history of collaborative 
                        activities carried out by the 
                        participants in the network;
                            (ii) the degree to which the 
                        participants are ready to integrate 
                        their functions; and
                            (iii) how the local community or 
                        region to be served will benefit from 
                        and be involved in the activities 
                        carried out by the network;
                    (D) a description of how the local 
                community or region to be served will 
                experience increased access to quality health 
                care services across the continuum of care as a 
                result of the integration activities carried 
                out by the network;
                    (E) a plan for sustaining the project after 
                Federal support for the project has ended;
                    (F) a description of how the project will 
                be evaluated; and
                    (G) other such information as the Secretary 
                determines to be appropriate.
    (g) Small Health Care Provider Quality Improvement 
Grants.--
            (1) Grants.--The Director may award grants to 
        provide for the planning and implementation of small 
        health care provider quality improvement activities. 
        The Director may award the grants for periods of 1 to 3 
        years.
            (2) Eligibility.--To be eligible for a grant under 
        this subsection, an entity--
                    (A)(i) shall be a rural public or rural 
                nonprofit private health care provider or 
                provider of health care services, such as a 
                critical access hospital or a rural health 
                clinic; or
                    (ii) shall be another rural provider or 
                network of small rural providers identified by 
                the Secretary as a key source of local care; 
                and
                    (B) shall not previously have received a 
                grant under this subsection for the same or a 
                similar project.
            (3) Applications.--To be eligible to receive a 
        grant under this subsection, an eligible entity, in 
        consultation with the appropriate State office of rural 
        health or another appropriate State entity shall 
        prepare and submit to the Secretary an application, at 
        such time, in such manner, and containing such 
        information as the Secretary may require, including--
                    (A) a description of the project that the 
                eligible entity will carry out using the funds 
                provided under the grant;
                    (B) an explanation of the reasons why 
                Federal assistance is required to carry out the 
                project;
                    (C) a description of the manner in which 
                the project funded under the grant will assure 
                continuous quality improvement in the provision 
                of services by the entity;
                    (D) a description of how the local 
                community or region to be served will 
                experience increased access to quality health 
                care services across the continuum of care as a 
                result of the activities carried out by the 
                entity;
                    (E) a plan for sustaining the project after 
                Federal support for the project has ended;
                    (F) a description of how the project will 
                be evaluated; and
                    (G) other such information as the Secretary 
                determines to be appropriate.
            (4) Expenditures for small health care provider 
        quality improvement grants.--In awarding a grant under 
        this subsection, the Director shall ensure that the 
        funds made available through the grant will be used to 
        provide services to residents of rural areas. The 
        Director shall award not less than 50 percent of the 
        funds made available under this subsection to providers 
        located in and serving rural areas.
    (h) General Requirements.--
            (1) Prohibited uses of funds.--An entity that 
        receives a grant under this section may not use funds 
        provided through the grant--
                    (A) to build or acquire real property; or
                    (B) for construction.
            (2) Coordination with other agencies.--The 
        Secretary shall coordinate activities carried out under 
        grant programs described in this section, to the extent 
        practicable, with Federal and State agencies and 
        nonprofit organizations that are operating similar 
        grant programs, to maximize the effect of public 
        dollars in funding meritorious proposals.
            (3) Preference.--In awarding grants under this 
        section, the Secretary shall give preference to 
        entities that--
                    (A) are located in health professional 
                shortage areas or medically underserved 
                communities, or serve medically underserved 
                populations; or
                    (B) propose to develop projects with a 
                focus on primary care, and wellness and 
                prevention strategies.
    (i) Report.--Not later than September 30, 2005, the 
Secretary shall prepare and submit to the appropriate 
committees of Congress a report on the progress and 
accomplishments of the grant programs described in subsections 
(e), (f), and (g).
    (j) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section $45,000,000 for 
each of fiscal years 2008 through 2012.

SEC. 330A-1. [254C-1A] GRANTS TO NURSE-MANAGED HEALTH CLINICS.

    (a) Definitions.--
            (1) Comprehensive primary health care services.--In 
        this section, the term ``comprehensive primary health 
        care services'' means the primary health services 
        described in section 330(b)(1).
            (2) Nurse-managed health clinic.--The term ``nurse-
        managed health clinic'' means a nurse-practice 
        arrangement, managed by advanced practice nurses, that 
        provides primary care or wellness services to 
        underserved or vulnerable populations and that is 
        associated with a school, college, university or 
        department of nursing, federally qualified health 
        center, or independent nonprofit health or social 
        services agency.
    (b) Authority to Award Grants.--The Secretary shall award 
grants for the cost of the operation of nurse-managed health 
clinics that meet the requirements of this section.
    (c) Applications.--To be eligible to receive a grant under 
this section, an entity shall--
            (1) be an NMHC; and
            (2) submit to the Secretary an application at such 
        time, in such manner, and containing--
                    (A) assurances that nurses are the major 
                providers of services at the NMHC and that at 
                least 1 advanced practice nurse holds an 
                executive management position within the 
                organizational structure of the NMHC;
                    (B) an assurance that the NMHC will 
                continue providing comprehensive primary health 
                care services or wellness services without 
                regard to income or insurance status of the 
                patient for the duration of the grant period; 
                and
                    (C) an assurance that, not later than 90 
                days of receiving a grant under this section, 
                the NMHC will establish a community advisory 
                committee, for which a majority of the members 
                shall be individuals who are served by the 
                NMHC.
    (d) Grant Amount.--The amount of any grant made under this 
section for any fiscal year shall be determined by the 
Secretary, taking into account--
            (1) the financial need of the NMHC, considering 
        State, local, and other operational funding provided to 
        the NMHC; and
            (2) other factors, as the Secretary determines 
        appropriate.
    (e) Authorization of Appropriations.--For the purposes of 
carrying out this section, there are authorized to be 
appropriated $50,000,000 for the fiscal year 2010 and such sums 
as may be necessary for each of the fiscal years 2011 through 
2014.

SEC. 330B. [254C-2] SPECIAL DIABETES PROGRAMS FOR TYPE I DIABETES. \1\
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    \1\ Section 4923 of Public Law 105-33 (111 Stat. 574, as amended by 
section 1(c) of Public Law 107-360 (116 Stat. 3019),) requires the 
Secretary of Health and Human Services to conduct evaluations regarding 
programs under sections 330B and 330C. An interim report is required to 
be submitted to the appropriate committees of Congress not later than 
January 1, 2000, and a final report is required to be submitted not 
later than January 1, 2007.
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    (a) In General.--The Secretary, directly or through grants, 
shall provide for research into the prevention and cure of Type 
I diabetes.
    (b) Funding.--
            (1) Transferred funds.--Notwithstanding section 
        2104(a) of the Social Security Act, from the amounts 
        appropriated in such section for each of fiscal years 
        1998 through 2002, $30,000,000 is hereby transferred 
        and made available in such fiscal year for grants under 
        this section.
            (2) Appropriations.--For the purpose of making 
        grants under this section, there is appropriated, out 
        of any funds in the Treasury not otherwise 
        appropriated--
                    (A) $70,000,000 for each of fiscal years 
                2001 and 2002 (which shall be combined with 
                amounts transferred under paragraph (1) for 
                each such fiscal years);
                    (B) $100,000,000 for fiscal year 2003; and
                    (C) $150,000,000 for each of fiscal years 
                2004 through 2013.

SEC. 330C. [254C-3] SPECIAL DIABETES PROGRAMS FOR INDIANS. \1\

    (a) In General.--The Secretary shall make grants for 
providing services for the prevention and treatment of diabetes 
in accordance with subsection (b).
    (b) Services Through Indian Health Facilities.--For 
purposes of subsection (a), services under such subsection are 
provided in accordance with this subsection if the services are 
provided through any of the following entities:
            (1) The Indian Health Service.
            (2) An Indian health program operated by an Indian 
        tribe or tribal organization pursuant to a contract, 
        grant, cooperative agreement, or compact with the 
        Indian Health Service pursuant to the Indian Self-
        Determination Act.
            (3) An urban Indian health program operated by an 
        urban Indian organization pursuant to a grant or 
        contract with the Indian Health Service pursuant to 
        title V of the Indian Health Care Improvement Act.
    (c) Funding.--
            (1) Transferred funds.--Notwithstanding section 
        2104(a) of the Social Security Act, from the amounts 
        appropriated in such section for each of fiscal years 
        1998 through 2002, $30,000,000, to remain available 
        until expended, is hereby transferred and made 
        available in such fiscal year for grants under this 
        section.
            (2) Appropriations.--For the purpose of making 
        grants under this section, there is appropriated, out 
        of any money in the Treasury not otherwise 
        appropriated--
                    (A) $70,000,000 for each of fiscal years 
                2001 and 2002 (which shall be combined with 
                amounts transferred under paragraph (1) for 
                each such fiscal years);
                    (B) $100,000,000 for fiscal year 2003; and
                    (C) $150,000,000 for each of fiscal years 
                2004 through 2013.

SEC. 330D. [254C-4] CENTERS FOR STRATEGIES ON FACILITATING UTILIZATION 
                    OF PREVENTIVE HEALTH SERVICES AMONG VARIOUS 
                    POPULATIONS.

    (a) In General.--The Secretary, acting through the 
appropriate agencies of the Public Health Service, shall make 
grants to public or nonprofit private entities for the 
establishment and operation of regional centers whose purpose 
is to develop, evaluate, and disseminate effective strategies, 
which utilize quality management measures, to assist public and 
private health care programs and providers in the appropriate 
utilization of preventive health care services by specific 
populations.
    (b) Research and Training.--The activities carried out by a 
center under subsection (a) may include establishing programs 
of research and training with respect to the purpose described 
in such subsection, including the development of curricula for 
training individuals in implementing the strategies developed 
under such subsection.
    (c) Priority Regarding Infants and Children.--In carrying 
out the purpose described in subsection (a), the Secretary 
shall give priority to various populations of infants, young 
children, and their mothers.
    (d) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2000 through 2004.

SEC. 330E. [254C-5] EPILEPSY; SEIZURE DISORDER.

    (a) National Public Health Campaign.--
            (1) In general.--The Secretary shall develop and 
        implement public health surveillance, education, 
        research, and intervention strategies to improve the 
        lives of persons with epilepsy, with a particular 
        emphasis on children. Such projects may be carried out 
        by the Secretary directly and through awards of grants 
        or contracts to public or nonprofit private entities. 
        The Secretary may directly or through such awards 
        provide technical assistance with respect to the 
        planning, development, and operation of such projects.
            (2) Certain activities.--Activities under paragraph 
        (1) shall include--
                    (A) expanding current surveillance 
                activities through existing monitoring systems 
                and improving registries that maintain data on 
                individuals with epilepsy, including children;
                    (B) enhancing research activities on the 
                diagnosis, treatment, and management of 
                epilepsy;
                    (C) implementing public and professional 
                information and education programs regarding 
                epilepsy, including initiatives which promote 
                effective management of the disease through 
                children's programs which are targeted to 
                parents, schools, daycare providers, patients;
                    (D) undertaking educational efforts with 
                the media, providers of health care, schools 
                and others regarding stigmas and secondary 
                disabilities related to epilepsy and seizures, 
                and its effects on youth;
                    (E) utilizing and expanding partnerships 
                with organizations with experience addressing 
                the health and related needs of people with 
                disabilities; and
                    (F) other activities the Secretary deems 
                appropriate.
            (3) Coordination of activities.--The Secretary 
        shall ensure that activities under this subsection are 
        coordinated as appropriate with other agencies of the 
        Public Health Service that carry out activities 
        regarding epilepsy and seizure.
    (b) Seizure Disorder; Demonstration Projects in Medically 
Underserved Areas.--
            (1) In general.--The Secretary, acting through the 
        Administrator of the Health Resources and Services 
        Administration, may make grants for the purpose of 
        carrying out demonstration projects to improve access 
        to health and other services regarding seizures to 
        encourage early detection and treatment in children and 
        others residing in medically underserved areas.
            (2) Application for grant.--A grant may not be 
        awarded under paragraph (1) unless an application 
        therefore is submitted to the Secretary and the 
        Secretary approves such application. Such application 
        shall be submitted in such form and manner and shall 
        contain such information as the Secretary may 
        prescribe.
    (c) Definitions.--For purposes of this section:
            (1) The term ``epilepsy'' refers to a chronic and 
        serious neurological condition characterized by 
        excessive electrical discharges in the brain causing 
        recurring seizures affecting all life activities. The 
        Secretary may revise the definition of such term to the 
        extent the Secretary determines necessary.
            (2) The term ``medically underserved'' has the 
        meaning applicable under section 799B(6).
    (d) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2001 through 2005.

SEC. 330F. [254C-6] CERTAIN SERVICES FOR PREGNANT WOMEN.

    (a) Infant Adoption Awareness.--
            (1) In general.--The Secretary shall make grants to 
        national, regional, or local adoption organizations for 
        the purpose of developing and implementing programs to 
        train the designated staff of eligible health centers 
        in providing adoption information and referrals to 
        pregnant women on an equal basis with all other courses 
        of action included in nondirective counseling to 
        pregnant women.
            (2) Best-practices guidelines.--
                    (A) In general.--A condition for the 
                receipt of a grant under paragraph (1) is that 
                the adoption organization involved agree that, 
                in providing training under such paragraph, the 
                organization will follow the guidelines 
                developed under subparagraph (B).
                    (B) Process for development of 
                guidelines.--
                            (i) In general.--The Secretary 
                        shall establish and supervise a process 
                        described in clause (ii) in which the 
                        participants are--
                                    (I) an appropriate number 
                                and variety of adoption 
                                organizations that, as a group, 
                                have expertise in all models of 
                                adoption practice and that 
                                represent all members of the 
                                adoption triad (birth mother, 
                                infant, and adoptive parent); 
                                and
                                    (II) affected public health 
                                entities.
                            (ii) Description of process.--The 
                        process referred to in clause (i) is a 
                        process in which the participants 
                        described in such clause collaborate to 
                        develop best-practices guidelines on 
                        the provision of adoption information 
                        and referrals to pregnant women on an 
                        equal basis with all other courses of 
                        action included in nondirective 
                        counseling to pregnant women.
                            (iii) Date certain for 
                        development.--The Secretary shall 
                        ensure that the guidelines described in 
                        clause (ii) are developed not later 
                        than 180 days after the date of the 
                        enactment of the Children's Health Act 
                        of 2000 \1\.
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    \1\ Public Law 106-310, enacted October 17, 2000.
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                    (C) Relation to authority for grants.--The 
                Secretary may not make any grant under 
                paragraph (1) before the date on which the 
                guidelines under subparagraph (B) are 
                developed.
            (3) Use of grant.--
                    (A) In general.--With respect to a grant 
                under paragraph (1)--
                            (i) an adoption organization may 
                        expend the grant to carry out the 
                        programs directly or through grants to 
                        or contracts with other adoption 
                        organizations;
                            (ii) the purposes for which the 
                        adoption organization expends the grant 
                        may include the development of a 
                        training curriculum, consistent with 
                        the guidelines developed under 
                        paragraph (2)(B); and
                            (iii) a condition for the receipt 
                        of the grant is that the adoption 
                        organization agree that, in providing 
                        training for the designated staff of 
                        eligible health centers, such 
                        organization will make reasonable 
                        efforts to ensure that the individuals 
                        who provide the training are 
                        individuals who are knowledgeable in 
                        all elements of the adoption process 
                        and are experienced in providing 
                        adoption information and referrals in 
                        the geographic areas in which the 
                        eligible health centers are located, 
                        and that the designated staff receive 
                        the training in such areas.
                    (B) Rule of construction regarding training 
                of trainers.--With respect to individuals who 
                under a grant under paragraph (1) provide 
                training for the designated staff of eligible 
                health centers (referred to in this 
                subparagraph as ``trainers''), subparagraph 
                (A)(iii) may not be construed as establishing 
                any limitation regarding the geographic area in 
                which the trainers receive instruction in being 
                such trainers. A trainer may receive such 
                instruction in a different geographic area than 
                the area in which the trainer trains (or will 
                train) the designated staff of eligible health 
                centers.
            (4) Adoption organizations; eligible health 
        centers; other definitions.--For purposes of this 
        section:
                    (A) The term ``adoption organization'' 
                means a national, regional, or local 
                organization--
                            (i) among whose primary purposes 
                        are adoption;
                            (ii) that is knowledgeable in all 
                        elements of the adoption process and on 
                        providing adoption information and 
                        referrals to pregnant women; and
                            (iii) that is a nonprofit private 
                        entity.
                    (B) The term ``designated staff'', with 
                respect to an eligible health center, means 
                staff of the center who provide pregnancy or 
                adoption information and referrals (or will 
                provide such information and referrals after 
                receiving training under a grant under 
                paragraph (1)).
                    (C) The term ``eligible health centers'' 
                means public and nonprofit private entities 
                that provide health services to pregnant women.
            (5) Training for certain eligible health centers.--
        A condition for the receipt of a grant under paragraph 
        (1) is that the adoption organization involved agree to 
        make reasonable efforts to ensure that the eligible 
        health centers with respect to which training under the 
        grant is provided include--
                    (A) eligible health centers that receive 
                grants under section 1001 (relating to 
                voluntary family planning projects);
                    (B) eligible health centers that receive 
                grants under section 330 (relating to community 
                health centers, migrant health centers, and 
                centers regarding homeless individuals and 
                residents of public housing); and
                    (C) eligible health centers that receive 
                grants under this Act for the provision of 
                services in schools.
            (6) Participation of certain eligible health 
        clinics.--In the case of eligible health centers that 
        receive grants under section 330 or 1001:
                    (A) Within a reasonable period after the 
                Secretary begins making grants under paragraph 
                (1), the Secretary shall provide eligible 
                health centers with complete information about 
                the training available from organizations 
                receiving grants under such paragraph. The 
                Secretary shall make reasonable efforts to 
                encourage eligible health centers to arrange 
                for designated staff to participate in such 
                training. Such efforts shall affirm Federal 
                requirements, if any, that the eligible health 
                center provide nondirective counseling to 
                pregnant women.
                    (B) All costs of such centers in obtaining 
                the training shall be reimbursed by the 
                organization that provides the training, using 
                grants under paragraph (1).
                    (C) Not later than 1 year after the date of 
                the enactment of the Children's Health Act of 
                2000 \1\, the Secretary shall submit to the 
                appropriate committees of the Congress a report 
                evaluating the extent to which adoption 
                information and referral, upon request, are 
                provided by eligible health centers. Within a 
                reasonable time after training under this 
                section is initiated, the Secretary shall 
                submit to the appropriate committees of the 
                Congress a report evaluating the extent to 
                which adoption information and referral, upon 
                request, are provided by eligible health 
                centers in order to determine the effectiveness 
                of such training and the extent to which such 
                training complies with subsection (a)(1). In 
                preparing the reports required by this 
                subparagraph, the Secretary shall in no respect 
                interpret the provisions of this section to 
                allow any interference in the provider-patient 
                relationship, any breach of patient 
                confidentiality, or any monitoring or auditing 
                of the counseling process or patient records 
                which breaches patient confidentiality or 
                reveals patient identity. The reports required 
                by this subparagraph shall be conducted by the 
                Secretary acting through the Administrator of 
                the Health Resources and Services 
                Administration and in collaboration with the 
                Director of the Agency for Healthcare Research 
                and Quality.
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    \1\ Public Law 106-310, enacted October 17, 2000.
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    (b) Application for Grant.--The Secretary may make a grant 
under subsection (a) only if an application for the grant is 
submitted to the Secretary and the application is in such form, 
is made in such manner, and contains such agreements, 
assurances, and information as the Secretary determines to be 
necessary to carry out this section.
    (c) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2001 through 2005.

SEC. 330G. [254C-7] SPECIAL NEEDS ADOPTION PROGRAMS; PUBLIC AWARENESS 
                    CAMPAIGN AND OTHER ACTIVITIES.

    (a) Special Needs Adoption Awareness Campaign.--
            (1) In general.--The Secretary shall, through 
        making grants to nonprofit private entities, provide 
        for the planning, development, and carrying out of a 
        national campaign to provide information to the public 
        regarding the adoption of children with special needs.
            (2) Input on planning and development.--In 
        providing for the planning and development of the 
        national campaign under paragraph (1), the Secretary 
        shall provide for input from a number and variety of 
        adoption organizations throughout the States in order 
        that the full national diversity of interests among 
        adoption organizations is represented in the planning 
        and development of the campaign.
            (3) Certain features.--With respect to the national 
        campaign under paragraph (1):
                    (A) The campaign shall be directed at 
                various populations, taking into account as 
                appropriate differences among geographic 
                regions, and shall be carried out in the 
                language and cultural context that is most 
                appropriate to the population involved.
                    (B) The means through which the campaign 
                may be carried out include--
                            (i) placing public service 
                        announcements on television, radio, and 
                        billboards; and
                            (ii) providing information through 
                        means that the Secretary determines 
                        will reach individuals who are most 
                        likely to adopt children with special 
                        needs.
                    (C) The campaign shall provide information 
                on the subsidies and supports that are 
                available to individuals regarding the adoption 
                of children with special needs.
                    (D) The Secretary may provide that the 
                placement of public service announcements, and 
                the dissemination of brochures and other 
                materials, is subject to review by the 
                Secretary.
            (4) Matching Requirement.--
                    (A) In general.--With respect to the costs 
                of the activities to be carried out by an 
                entity pursuant to paragraph (1), a condition 
                for the receipt of a grant under such paragraph 
                is that the entity agree to make available 
                (directly or through donations from public or 
                private entities) non-Federal contributions 
                toward such costs in an amount that is not less 
                than 25 percent of such costs.
                    (B) Determination of amount contributed.--
                Non-Federal contributions under subparagraph 
                (A) may be in cash or in kind, fairly 
                evaluated, including plant, equipment, or 
                services. Amounts provided by the Federal 
                Government, or services assisted or subsidized 
                to any significant extent by the Federal 
                Government, may not be included in determining 
                the amount of such contributions.
    (b) National Resources Program.--The Secretary shall 
(directly or through grant or contract) carry out a program 
that, through toll-free telecommunications, makes available to 
the public information regarding the adoption of children with 
special needs. Such information shall include the following:
            (1) A list of national, State, and regional 
        organizations that provide services regarding such 
        adoptions, including exchanges and other information on 
        communicating with the organizations. The list shall 
        represent the full national diversity of adoption 
        organizations.
            (2) Information beneficial to individuals who adopt 
        such children, including lists of support groups for 
        adoptive parents and other postadoptive services.
    (c) Other Programs.--With respect to the adoption of 
children with special needs, the Secretary shall make grants--
            (1) to provide assistance to support groups for 
        adoptive parents, adopted children, and siblings of 
        adopted children; and
            (2) to carry out studies to identify--
                    (A) the barriers to completion of the 
                adoption process; and
                    (B) those components that lead to favorable 
                long-term outcomes for families that adopt 
                children with special needs.
    (d) Application for Grant.--The Secretary may make an award 
of a grant or contract under this section only if an 
application for the award is submitted to the Secretary and the 
application is in such form, is made in such manner, and 
contains such agreements, assurances, and information as the 
Secretary determines to be necessary to carry out this section.
    (e) Funding.--For the purpose of carrying out this section, 
there are authorized to be appropriated such sums as may be 
necessary for each of the fiscal years 2001 through 2005.

SEC. 330H. [254C-8] HEALTHY START FOR INFANTS.

    (a) In General.--
            (1) Continuation and expansion of program.--The 
        Secretary, acting through the Administrator of the 
        Health Resources and Services Administration, Maternal 
        and Child Health Bureau, shall under authority of this 
        section continue in effect the Healthy Start Initiative 
        and may, during fiscal year 2001 and subsequent years, 
        carry out such program on a national basis.
            (2) Definition.--For purposes of paragraph (1), the 
        term ``Healthy Start Initiative'' is a reference to the 
        program that, as an initiative to reduce the rate of 
        infant mortality and improve perinatal outcomes, makes 
        grants for project areas with high annual rates of 
        infant mortality and that, prior to the effective date 
        of this section, was a demonstration program carried 
        out under section 301.
    (b) Considerations in Making Grants.--
            (1) Requirements.--In making grants under 
        subsection (a), the Secretary shall require that 
        applicants (in addition to meeting all eligibility 
        criteria established by the Secretary) establish, for 
        project areas under such subsection, community-based 
        consortia of individuals and organizations (including 
        agencies responsible for administering block grant 
        programs under title V of the Social Security Act, 
        consumers of project services, public health 
        departments, hospitals, health centers under section 
        330, and other significant sources of health care 
        services) that are appropriate for participation in 
        projects under subsection (a).
            (2) Other considerations.--In making grants under 
        subsection (a), the Secretary shall take into 
        consideration the following:
                    (A) Factors that contribute to infant 
                mortality, such as low birthweight.
                    (B) The extent to which applicants for such 
                grants facilitate--
                            (i) a community-based approach to 
                        the delivery of services; and
                            (ii) a comprehensive approach to 
                        women's health care to improve 
                        perinatal outcomes.
            (3) Special projects.--Nothing in paragraph (2) 
        shall be construed to prevent the Secretary from 
        awarding grants under subsection (a) for special 
        projects that are intended to address significant 
        disparities in perinatal health indicators in 
        communities along the United States-Mexico border or in 
        Alaska or Hawaii.
    (c) Coordination.--Recipients of grants under subsection 
(a) shall coordinate their services and activities with the 
State agency or agencies that administer block grant programs 
under title V of the Social Security Act in order to promote 
cooperation, integration, and dissemination of information with 
Statewide systems and with other community services funded 
under the Maternal and Child Health Block Grant.
    (d) Rule of Construction.--Except to the extent 
inconsistent with this section, this section may not be 
construed as affecting the authority of the Secretary to make 
modifications in the program carried out under subsection (a).
    (e) Funding.--
            (1) Authorization of appropriations.--For the 
        purpose of carrying out this section, there are 
        authorized to be appropriated--
                    (A) $120,000,000 for fiscal year 2008; and
                    (B) for each of fiscal years 2009 through 
                2013, the amount authorized for the preceding 
                fiscal year increased by the percentage 
                increase in the Consumer Price Index for all 
                urban consumers for such year.
            (2) Allocation.--
                    (A) Program administration.--Of the amounts 
                appropriated under paragraph (1) for a fiscal 
                year, the Secretary may reserve up to 5 percent 
                for coordination, dissemination, technical 
                assistance, and data activities that are 
                determined by the Secretary to be appropriate 
                for carrying out the program under this 
                section.
                    (B) Evaluation.--Of the amounts 
                appropriated under paragraph (1) for a fiscal 
                year, the Secretary may reserve up to 1 percent 
                for evaluations of projects carried out under 
                subsection (a). Each such evaluation shall 
                include a determination of whether such 
                projects have been effective in reducing the 
                disparity in health status between the general 
                population and individuals who are members of 
                racial or ethnic minority groups.

SEC. 330I. [254C-14] TELEHEALTH NETWORK AND TELEHEALTH RESOURCE CENTERS 
                    GRANT PROGRAMS.

    (a) Definitions.--In this section:
            (1) Director; office.--The terms ``Director'' and 
        ``Office'' mean the Director and Office specified in 
        subsection (c).
            (2) Federally qualified health center and rural 
        health clinic.--The term ``Federally qualified health 
        center'' and ``rural health clinic'' have the meanings 
        given the terms in section 1861(aa) of the Social 
        Security Act (42 U.S.C. 1395x(aa)).
            (3) Frontier community.--The term ``frontier 
        community'' shall have the meaning given the term in 
        regulations issued under subsection (r).
            (4) Medically underserved area.--The term 
        ``medically underserved area'' has the meaning given 
        the term ``medically underserved community'' in section 
        799B(6).
            (5) Medically underserved population.--The term 
        ``medically underserved population'' has the meaning 
        given the term in section 330(b)(3).
            (6) Telehealth services.--The term ``telehealth 
        services'' means services provided through telehealth 
        technologies.
            (7) Telehealth technologies.--The term ``telehealth 
        technologies'' means technologies relating to the use 
        of electronic information, and telecommunications 
        technologies, to support and promote, at a distance, 
        health care, patient and professional health-related 
        education, health administration, and public health.
    (b) Programs.--The Secretary shall establish, under section 
301, telehealth network and telehealth resource centers grant 
programs.
    (c) Administration.--
            (1) Establishment.--There is established in the 
        Health Resources and Services Administration an Office 
        for the Advancement of Telehealth. The Office shall be 
        headed by a Director.
            (2) Duties.--The telehealth network and telehealth 
        resource centers grant programs established under 
        section 301 shall be administered by the Director, in 
        consultation with the State offices of rural health, 
        State offices concerning primary care, or other 
        appropriate State government entities.
    (d) Grants.--
            (1) Telehealth network grants.--The Director may, 
        in carrying out the telehealth network grant program 
        referred to in subsection (b), award grants to eligible 
        entities for projects to demonstrate how telehealth 
        technologies can be used through telehealth networks in 
        rural areas, frontier communities, and medically 
        underserved areas, and for medically underserved 
        populations, to--
                    (A) expand access to, coordinate, and 
                improve the quality of health care services;
                    (B) improve and expand the training of 
                health care providers; and
                    (C) expand and improve the quality of 
                health information available to health care 
                providers, and patients and their families, for 
                decisionmaking.
            (2) Telehealth resource centers grants.--The 
        Director may, in carrying out the telehealth resource 
        centers grant program referred to in subsection (b), 
        award grants to eligible entities for projects to 
        demonstrate how telehealth technologies can be used in 
        the areas and communities, and for the populations, 
        described in paragraph (1), to establish telehealth 
        resource centers.
    (e) Grant Periods.--The Director may award grants under 
this section for periods of not more than 4 years.
    (f) Eligible Entities.--
            (1) Telehealth network grants.--
                    (A) Grant recipient.--To be eligible to 
                receive a grant under subsection (d)(1), an 
                entity shall be a nonprofit entity.
                    (B) Telehealth networks.--
                            (i) In general.--To be eligible to 
                        receive a grant under subsection 
                        (d)(1), an entity shall demonstrate 
                        that the entity will provide services 
                        through a telehealth network.
                            (ii) Nature of entities.--Each 
                        entity participating in the telehealth 
                        network may be a nonprofit or for-
                        profit entity.
                            (iii) Composition of network.--The 
                        telehealth network shall include at 
                        least 2 of the following entities (at 
                        least 1 of which shall be a community-
                        based health care provider):
                                    (I) Community or migrant 
                                health centers or other 
                                Federally qualified health 
                                centers.
                                    (II) Health care providers, 
                                including pharmacists, in 
                                private practice.
                                    (III) Entities operating 
                                clinics, including rural health 
                                clinics.
                                    (IV) Local health 
                                departments.
                                    (V) Nonprofit hospitals, 
                                including community access 
                                hospitals.
                                    (VI) Other publicly funded 
                                health or social service 
                                agencies.
                                    (VII) Long-term care 
                                providers.
                                    (VIII) Providers of health 
                                care services in the home.
                                    (IX) Providers of 
                                outpatient mental health 
                                services and entities operating 
                                outpatient mental health 
                                facilities.
                                    (X) Local or regional 
                                emergency health care 
                                providers.
                                    (XI) Institutions of higher 
                                education.
                                    (XII) Entities operating 
                                dental clinics.
            (2) Telehealth resource centers grants.--To be 
        eligible to receive a grant under subsection (d)(2), an 
        entity shall be a nonprofit entity.
    (g) Applications.--To be eligible to receive a grant under 
subsection (d), an eligible entity, in consultation with the 
appropriate State office of rural health or another appropriate 
State entity, shall prepare and submit to the Secretary an 
application, at such time, in such manner, and containing such 
information as the Secretary may require, including--
            (1) a description of the project that the eligible 
        entity will carry out using the funds provided under 
        the grant;
            (2) a description of the manner in which the 
        project funded under the grant will meet the health 
        care needs of rural or other populations to be served 
        through the project, or improve the access to services 
        of, and the quality of the services received by, those 
        populations;
            (3) evidence of local support for the project, and 
        a description of how the areas, communities, or 
        populations to be served will be involved in the 
        development and ongoing operations of the project;
            (4) a plan for sustaining the project after Federal 
        support for the project has ended;
            (5) information on the source and amount of non-
        Federal funds that the entity will provide for the 
        project;
            (6) information demonstrating the long-term 
        viability of the project, and other evidence of 
        institutional commitment of the entity to the project;
            (7) in the case of an application for a project 
        involving a telehealth network, information 
        demonstrating how the project will promote the 
        integration of telehealth technologies into the 
        operations of health care providers, to avoid 
        redundancy, and improve access to and the quality of 
        care; and
            (8) other such information as the Secretary 
        determines to be appropriate.
    (h) Terms; Conditions; Maximum Amount of Assistance.--The 
Secretary shall establish the terms and conditions of each 
grant program described in subsection (b) and the maximum 
amount of a grant to be awarded to an individual recipient for 
each fiscal year under this section. The Secretary shall 
publish, in a publication of the Health Resources and Services 
Administration, notice of the application requirements for each 
grant program described in subsection (b) for each fiscal year.
    (i) Preferences.--
            (1) Telehealth networks.--In awarding grants under 
        subsection (d)(1) for projects involving telehealth 
        networks, the Secretary shall give preference to an 
        eligible entity that meets at least 1 of the following 
        requirements:
                    (A) Organization.--The eligible entity is a 
                rural community-based organization or another 
                community-based organization.
                    (B) Services.--The eligible entity proposes 
                to use Federal funds made available through 
                such a grant to develop plans for, or to 
                establish, telehealth networks that provide 
                mental health, public health, long-term care, 
                home care, preventive, or case management 
                services.
                    (C) Coordination.--The eligible entity 
                demonstrates how the project to be carried out 
                under the grant will be coordinated with other 
                relevant federally funded projects in the 
                areas, communities, and populations to be 
                served through the grant.
                    (D) Network.--The eligible entity 
                demonstrates that the project involves a 
                telehealth network that includes an entity 
                that--
                            (i) provides clinical health care 
                        services, or educational services for 
                        health care providers and for patients 
                        or their families; and
                            (ii) is--
                                    (I) a public library;
                                    (II) an institution of 
                                higher education; or
                                    (III) a local government 
                                entity.
                    (E) Connectivity.--The eligible entity 
                proposes a project that promotes local 
                connectivity within areas, communities, or 
                populations to be served through the project.
                    (F) Integration.--The eligible entity 
                demonstrates that health care information has 
                been integrated into the project.
            (2) Telehealth resource centers.--In awarding 
        grants under subsection (d)(2) for projects involving 
        telehealth resource centers, the Secretary shall give 
        preference to an eligible entity that meets at least 1 
        of the following requirements:
                    (A) Provision of services.--The eligible 
                entity has a record of success in the provision 
                of telehealth services to medically underserved 
                areas or medically underserved populations.
                    (B) Collaboration and sharing of 
                expertise.--The eligible entity has a 
                demonstrated record of collaborating and 
                sharing expertise with providers of telehealth 
                services at the national, regional, State, and 
                local levels.
                    (C) Broad range of telehealth services.--
                The eligible entity has a record of providing a 
                broad range of telehealth services, which may 
                include--
                            (i) a variety of clinical specialty 
                        services;
                            (ii) patient or family education;
                            (iii) health care professional 
                        education; and
                            (iv) rural residency support 
                        programs.
    (j) Distribution of Funds.--
            (1) In general.--In awarding grants under this 
        section, the Director shall ensure, to the greatest 
        extent possible, that such grants are equitably 
        distributed among the geographical regions of the 
        United States.
            (2) Telehealth networks.--In awarding grants under 
        subsection (d)(1) for a fiscal year, the Director shall 
        ensure that--
                    (A) not less than 50 percent of the funds 
                awarded shall be awarded for projects in rural 
                areas; and
                    (B) the total amount of funds awarded for 
                such projects for that fiscal year shall be not 
                less than the total amount of funds awarded for 
                such projects for fiscal year 2001 under 
                section 330A (as in effect on the day before 
                the date of enactment of the Health Care Safety 
                Net Amendments of 2002).
    (k) Use of Funds.--
            (1) Telehealth network program.--The recipient of a 
        grant under subsection (d)(1) may use funds received 
        through such grant for salaries, equipment, and 
        operating or other costs, including the cost of--
                    (A) developing and delivering clinical 
                telehealth services that enhance access to 
                community-based health care services in rural 
                areas, frontier communities, or medically 
                underserved areas, or for medically underserved 
                populations;
                    (B) developing and acquiring, through lease 
                or purchase, computer hardware and software, 
                audio and video equipment, computer network 
                equipment, interactive equipment, data terminal 
                equipment, and other equipment that furthers 
                the objectives of the telehealth network grant 
                program;
                    (C)(i) developing and providing distance 
                education, in a manner that enhances access to 
                care in rural areas, frontier communities, or 
                medically underserved areas, or for medically 
                underserved populations; or
                    (ii) mentoring, precepting, or supervising 
                health care providers and students seeking to 
                become health care providers, in a manner that 
                enhances access to care in the areas and 
                communities, or for the populations, described 
                in clause (i);
                    (D) developing and acquiring instructional 
                programming;
                    (E)(i) providing for transmission of 
                medical data, and maintenance of equipment; and
                    (ii) providing for compensation (including 
                travel expenses) of specialists, and referring 
                health care providers, who are providing 
                telehealth services through the telehealth 
                network, if no third party payment is available 
                for the telehealth services delivered through 
                the telehealth network;
                    (F) developing projects to use telehealth 
                technology to facilitate collaboration between 
                health care providers;
                    (G) collecting and analyzing usage 
                statistics and data to document the cost-
                effectiveness of the telehealth services; and
                    (H) carrying out such other activities as 
                are consistent with achieving the objectives of 
                this section, as determined by the Secretary.
            (2) Telehealth resource centers.--The recipient of 
        a grant under subsection (d)(2) may use funds received 
        through such grant for salaries, equipment, and 
        operating or other costs for--
                    (A) providing technical assistance, 
                training, and support, and providing for travel 
                expenses, for health care providers and a range 
                of health care entities that provide or will 
                provide telehealth services;
                    (B) disseminating information and research 
                findings related to telehealth services;
                    (C) promoting effective collaboration among 
                telehealth resource centers and the Office;
                    (D) conducting evaluations to determine the 
                best utilization of telehealth technologies to 
                meet health care needs;
                    (E) promoting the integration of the 
                technologies used in clinical information 
                systems with other telehealth technologies;
                    (F) fostering the use of telehealth 
                technologies to provide health care information 
                and education for health care providers and 
                consumers in a more effective manner; and
                    (G) implementing special projects or 
                studies under the direction of the Office.
    (l) Prohibited Uses of Funds.--An entity that receives a 
grant under this section may not use funds made available 
through the grant--
            (1) to acquire real property;
            (2) for expenditures to purchase or lease 
        equipment, to the extent that the expenditures would 
        exceed 40 percent of the total grant funds;
            (3) in the case of a project involving a telehealth 
        network, to purchase or install transmission equipment 
        (such as laying cable or telephone lines, or purchasing 
        or installing microwave towers, satellite dishes, 
        amplifiers, or digital switching equipment);
            (4) to pay for any equipment or transmission costs 
        not directly related to the purposes for which the 
        grant is awarded;
            (5) to purchase or install general purpose voice 
        telephone systems;
            (6) for construction; or
            (7) for expenditures for indirect costs (as 
        determined by the Secretary), to the extent that the 
        expenditures would exceed 15 percent of the total grant 
        funds.
    (m) Collaboration.--In providing services under this 
section, an eligible entity shall collaborate, if feasible, 
with entities that--
            (1)(A) are private or public organizations, that 
        receive Federal or State assistance; or
            (B) are public or private entities that operate 
        centers, or carry out programs, that receive Federal or 
        State assistance; and
            (2) provide telehealth services or related 
        activities.
    (n) Coordination With Other Agencies.--The Secretary shall 
coordinate activities carried out under grant programs 
described in subsection (b), to the extent practicable, with 
Federal and State agencies and nonprofit organizations that are 
operating similar programs, to maximize the effect of public 
dollars in funding meritorious proposals.
    (o) Outreach Activities.--The Secretary shall establish and 
implement procedures to carry out outreach activities to advise 
potential end users of telehealth services in rural areas, 
frontier communities, medically underserved areas, and 
medically underserved populations in each State about the grant 
programs described in subsection (b).
    (p) Telehealth.--It is the sense of Congress that, for 
purposes of this section, States should develop reciprocity 
agreements so that a provider of services under this section 
who is a licensed or otherwise authorized health care provider 
under the law of 1 or more States, and who, through telehealth 
technology, consults with a licensed or otherwise authorized 
health care provider in another State, is exempt, with respect 
to such consultation, from any State law of the other State 
that prohibits such consultation on the basis that the first 
health care provider is not a licensed or authorized health 
care provider under the law of that State.
    (q) Report.--Not later than September 30, 2005, the 
Secretary shall prepare and submit to the appropriate 
committees of Congress a report on the progress and 
accomplishments of the grant programs described in subsection 
(b).
    (r) Regulations.--The Secretary shall issue regulations 
specifying, for purposes of this section, a definition of the 
term ``frontier area''. The definition shall be based on 
factors that include population density, travel distance in 
miles to the nearest medical facility, travel time in minutes 
to the nearest medical facility, and such other factors as the 
Secretary determines to be appropriate. The Secretary shall 
develop the definition in consultation with the Director of the 
Bureau of the Census and the Administrator of the Economic 
Research Service of the Department of Agriculture.
    (s) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section--
            (1) for grants under subsection (d)(1), $40,000,000 
        for fiscal year 2002, and such sums as may be necessary 
        for each of fiscal years 2003 through 2006; and
            (2) for grants under subsection (d)(2), $20,000,000 
        for fiscal year 2002, and such sums as may be necessary 
        for each of fiscal years 2003 through 2006.

SEC. 330J. [254C-15] RURAL EMERGENCY MEDICAL SERVICE TRAINING AND 
                    EQUIPMENT ASSISTANCE PROGRAM.

    (a) Grants.--The Secretary, acting through the 
Administrator of the Health Resources and Services 
Administration (referred to in this section as the 
``Secretary'') shall award grants to eligible entities to 
enable such entities to provide for improved emergency medical 
services in rural areas.
    (b) Eligibility.--To be eligible to receive a grant under 
this section, an entity shall--
            (1) be--
                    (A) a State emergency medical services 
                office;
                    (B) a State emergency medical services 
                association;
                    (C) a State office of rural health;
                    (D) a local government entity;
                    (E) a State or local ambulance provider; or
                    (F) any other entity determined appropriate 
                by the Secretary; and
            (2) prepare and submit to the Secretary an 
        application at such time, in such manner, and 
        containing such information as the Secretary may 
        require, that includes--
                    (A) a description of the activities to be 
                carried out under the grant; and
                    (B) an assurance that the eligible entity 
                will comply with the matching requirement of 
                subsection (e).
    (c) Use of Funds.--An entity shall use amounts received 
under a grant made under subsection (a), either directly or 
through grants to emergency medical service squads that are 
located in, or that serve residents of, a nonmetropolitan 
statistical area, an area designated as a rural area by any law 
or regulation of a State, or a rural census tract of a 
metropolitan statistical area (as determined under the most 
recent Goldsmith Modification, originally published in a notice 
of availability of funds in the Federal Register on February 
27, 1992, 57 Fed. Reg. 6725), to--
            (1) recruit emergency medical service personnel;
            (2) recruit volunteer emergency medical service 
        personnel;
            (3) train emergency medical service personnel in 
        emergency response, injury prevention, safety 
        awareness, and other topics relevant to the delivery of 
        emergency medical services;
            (4) fund specific training to meet Federal or State 
        certification requirements;
            (5) develop new ways to educate emergency health 
        care providers through the use of technology-enhanced 
        educational methods (such as distance learning);
            (6) acquire emergency medical services equipment, 
        including cardiac defibrillators;
            (7) acquire personal protective equipment for 
        emergency medical services personnel as required by the 
        Occupational Safety and Health Administration; and
            (8) educate the public concerning cardiopulmonary 
        resuscitation, first aid, injury prevention, safety 
        awareness, illness prevention, and other related 
        emergency preparedness topics.
    (d) Preference.--In awarding grants under this section the 
Secretary shall give preference to--
            (1) applications that reflect a collaborative 
        effort by 2 or more of the entities described in 
        subparagraphs (A) through (F) of subsection (b)(1); and
            (2) applications submitted by entities that intend 
        to use amounts provided under the grant to fund 
        activities described in any of paragraphs (1) through 
        (5) of subsection (c).
    (e) Matching Requirement.--The Secretary may not award a 
grant under this section to an entity unless the entity agrees 
that the entity will make available (directly or through 
contributions from other public or private entities) non-
Federal contributions toward the activities to be carried out 
under the grant in an amount equal to 25 percent of the amount 
received under the grant.
    (f) Emergency Medical Services.--In this section, the term 
``emergency medical services''--
            (1) means resources used by a qualified public or 
        private nonprofit entity, or by any other entity 
        recognized as qualified by the State involved, to 
        deliver medical care outside of a medical facility 
        under emergency conditions that occur--
                    (A) as a result of the condition of the 
                patient; or
                    (B) as a result of a natural disaster or 
                similar situation; and
            (2) includes services delivered by an emergency 
        medical services provider (either compensated or 
        volunteer) or other provider recognized by the State 
        involved that is licensed or certified by the State as 
        an emergency medical technician or its equivalent (as 
        determined by the State), a registered nurse, a 
        physician assistant, or a physician that provides 
        services similar to services provided by such an 
        emergency medical services provider.
    (g) Authorization of Appropriations.--
            (1) In general.--There are authorized to be 
        appropriated to carry out this section such sums as may 
        be necessary for each of fiscal years 2002 through 
        2006.
            (2) Administrative costs.--The Secretary may use 
        not more than 10 percent of the amount appropriated 
        under paragraph (1) for a fiscal year for the 
        administrative expenses of carrying out this section.

SEC. 330K. [254C-16] MENTAL HEALTH SERVICES DELIVERED VIA TELEHEALTH.

    (a) Definitions.--In this section:
            (1) Eligible entity.--The term ``eligible entity'' 
        means a public or nonprofit private telehealth provider 
        network that offers services that include mental health 
        services provided by qualified mental health providers.
            (2) Qualified mental health professionals.--The 
        term ``qualified mental health professionals'' refers 
        to providers of mental health services reimbursed under 
        the medicare program carried out under title XVIII of 
        the Social Security Act (42 U.S.C. 1395 et seq.) who 
        have additional training in the treatment of mental 
        illness in children and adolescents or who have 
        additional training in the treatment of mental illness 
        in the elderly.
            (3) Special populations.--The term ``special 
        populations'' refers to the following 2 distinct 
        groups:
                    (A) Children and adolescents in mental 
                health underserved rural areas or in mental 
                health underserved urban areas.
                    (B) Elderly individuals located in long-
                term care facilities in mental health 
                underserved rural or urban areas.
            (4) Telehealth.--The term ``telehealth'' means the 
        use of electronic information and telecommunications 
        technologies to support long distance clinical health 
        care, patient and professional health-related 
        education, public health, and health administration.
    (b) Program Authorized.--
            (1) In general.--The Secretary, acting through the 
        Director of the Office for the Advancement of 
        Telehealth of the Health Resources and Services 
        Administration, shall award grants to eligible entities 
        to establish demonstration projects for the provision 
        of mental health services to special populations as 
        delivered remotely by qualified mental health 
        professionals using telehealth and for the provision of 
        education regarding mental illness as delivered 
        remotely by qualified mental health professionals using 
        telehealth.
            (2) Populations served.--The Secretary shall award 
        the grants under paragraph (1) in a manner that 
        distributes the grants so as to serve equitably the 
        populations described in subparagraphs (A) and (B) of 
        subsection (a)(3).
    (c) Use of Funds.--
            (1) In general.--An eligible entity that receives a 
        grant under this section shall use the grant funds--
                    (A) for the populations described in 
                subsection (a)(3)(A)--
                            (i) to provide mental health 
                        services, including diagnosis and 
                        treatment of mental illness, as 
                        delivered remotely by qualified mental 
                        health professionals using telehealth; 
                        and
                            (ii) to collaborate with local 
                        public health entities to provide the 
                        mental health services; and
                    (B) for the populations described in 
                subsection (a)(3)(B)--
                            (i) to provide mental health 
                        services, including diagnosis and 
                        treatment of mental illness, in long-
                        term care facilities as delivered 
                        remotely by qualified mental health 
                        professionals using telehealth; and
                            (ii) to collaborate with local 
                        public health entities to provide the 
                        mental health services.
            (2) Other uses.--An eligible entity that receives a 
        grant under this section may also use the grant funds 
        to--
                    (A) pay telecommunications costs; and
                    (B) pay qualified mental health 
                professionals on a reasonable cost basis as 
                determined by the Secretary for services 
                rendered.
            (3) Prohibited uses.--An eligible entity that 
        receives a grant under this section shall not use the 
        grant funds to--
                    (A) purchase or install transmission 
                equipment (other than such equipment used by 
                qualified mental health professionals to 
                deliver mental health services using telehealth 
                under the project involved); or
                    (B) build upon or acquire real property.
    (d) Equitable Distribution.--In awarding grants under this 
section, the Secretary shall ensure, to the greatest extent 
possible, that such grants are equitably distributed among 
geographical regions of the United States.
    (e) Application.--An entity that desires a grant under this 
section shall submit an application to the Secretary at such 
time, in such manner, and containing such information as the 
Secretary determines to be reasonable.
    (f) Report.--Not later than 4 years after the date of 
enactment of the Health Care Safety Net Amendments of 2002, the 
Secretary shall prepare and submit to the appropriate 
committees of Congress a report that shall evaluate activities 
funded with grants under this section.
    (g) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section, $20,000,000 for 
fiscal year 2002 and such sums as may be necessary for fiscal 
years 2003 through 2006.

SEC. 330L. [254C-18] TELEMEDICINE; INCENTIVE GRANTS REGARDING 
                    COORDINATION AMONG STATES.

    (a) In General.--The Secretary may make grants to State 
professional licensing boards to carry out programs under which 
such licensing boards of various States cooperate to develop 
and implement State policies that will reduce statutory and 
regulatory barriers to telemedicine.
    (b) Authorization of Appropriations.--For the purpose of 
carrying out subsection (a), there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2002 through 2006.

           Subpart II--National Health Service Corps Program

                     national health service corps

    Sec. 331. [254d] (a)(1) For the purpose of eliminating 
health manpower \1\ shortages in health professional shortage 
areas, there is established, within the Service, the National 
Health Service Corps, which shall consist of--
---------------------------------------------------------------------------
    \1\ So in law. Probably should be ``health professional 
shortages''. See section 401 of Public Law 101-597 (104 Stat. 3035).
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            (A) such officers of the Regular and Reserve Corps 
        of the Service as the Secretary may designate,
            (B) such civilian employees of the United States as 
        the Secretary may appoint, and
            (C) such other individuals who are not employees of 
        the United States.
    (2) The Corps shall be utilized by the Secretary to provide 
primary health services in health professional shortage areas.
    (3) For purposes of this subpart and subpart III:
            (A) The term ``Corps'' means the National Health 
        Service Corps.
            (B) The term ``Corps member'' means each of the 
        officers, employees, and individuals of which the Corps 
        consists pursuant to paragraph (1).
            (C) The term ``health professional shortage area'' 
        has the meaning given such term in section 332(a).
            (D) The term ``primary health services'' means 
        health services regarding family medicine, internal 
        medicine, pediatrics, obstetrics and gynecology, 
        dentistry, or mental health, that are provided by 
        physicians or other health professionals.
            (E)(i) The term ``behavioral and mental health 
        professionals'' means health service psychologists, 
        licensed clinical social workers, licensed professional 
        counselors, marriage and family therapists, psychiatric 
        nurse specialists, and psychiatrists.
            (ii) The term `graduate program of behavioral and 
        mental health' means a program that trains behavioral 
        and mental health professionals.
    (b)(1) The Secretary may conduct at schools of medicine, 
osteopathic medicine, dentistry, and, as appropriate, nursing 
and other schools of the health professions, including schools 
at which graduate programs of behavioral and mental health are 
offered, and at entities which train allied health personnel, 
recruiting programs for the Corps, the Scholarship Program, and 
the Loan Repayment Program. Such recruiting programs shall 
include efforts to recruit individuals who will serve in the 
Corps other than pursuant to obligated service under the 
Scholarship or Loan Repayment Program.
    (2) In the case of physicians, dentists, behavioral and 
mental health professionals, certified nurse midwives, 
certified nurse practitioners, and physician assistants who 
have an interest and a commitment to providing primary health 
care, the Secretary may establish fellowship programs to enable 
such health professionals to gain exposure to and expertise in 
the delivery of primary health services in health professional 
shortage areas. To the maximum extent practicable, the 
Secretary shall ensure that any such programs are established 
in conjunction with accredited residency programs, and other 
training programs, regarding such health professions.
    (c)(1) The Secretary may reimburse an applicant for a 
position in the Corps (including an individual considering 
entering into a written agreement pursuant to section 338D) for 
the actual and reasonable expenses incurred in traveling to and 
from the applicant's place of residence to an eligible site to 
which the applicant may be assigned under section 333 for the 
purpose of evaluating such site with regard to being assigned 
at such site. The Secretary may establish a maximum total 
amount that may be paid to an individual as reimbursement for 
such expenses.
    (2) The Secretary may also reimburse the applicant for the 
actual and reasonable expenses incurred for the travel of 1 
family member to accompany the applicant to such site. The 
Secretary may establish a maximum total amount that may be paid 
to an individual as reimbursement for such expenses.
    (3) In the case of an individual who has entered into a 
contract for obligated service under the Scholarship Program or 
under the Loan Repayment Program, the Secretary may reimburse 
such individual for all or part of the actual and reasonable 
expenses incurred in transporting the individual, the 
individual's family, and the family's possessions to the site 
of the individual's assignment under section 333. The Secretary 
may establish a maximum total amount that may be paid to an 
individual as reimbursement for such expenses.
    (d)(1) The Secretary may, under regulations promulgated by 
the Secretary, adjust the monthly pay of each member of the 
Corps (other than a member described in subsection (a)(1)(C)) 
who is directly engaged in the delivery of health services in a 
health professional shortage area as follows:
            (A) During the first 36 months in which such a 
        member is so engaged in the delivery of health 
        services, his monthly pay may be increased by an amount 
        which when added to the member's monthly pay and 
        allowances will provide a monthly income competitive 
        with the average monthly income from a practice of an 
        individual who is a member of the profession of the 
        Corps member, who has equivalent training, and who has 
        been in practice for a period equivalent to the period 
        during which the Corps member has been in practice.
            (B) During the period beginning upon the expiration 
        of the 36 months referred to in subparagraph (A) and 
        ending with the month in which the member's monthly pay 
        and allowances are equal to or exceed the monthly 
        income he received for the last of such 36 months, the 
        member may receive in addition to his monthly pay and 
        allowances an amount which when added to such monthly 
        pay and allowances equals the monthly income he 
        received for such last month.
            (C) For each month in which a member is directly 
        engaged in the delivery of health services in a health 
        professional shortage area in accordance with an 
        agreement with the Secretary entered into under section 
        741(f)(1)(C), under which the Secretary is obligated to 
        make payments in accordance with section 741(f)(2), the 
        amount of any monthly increase under subparagraph (A) 
        or (B) with respect to such member shall be decreased 
        by an amount equal to one-twelfth of the amount which 
        the Secretary is obligated to pay upon the completion 
        of the year of practice in which such month occurs.
For purposes of subparagraphs (A) and (B), the term ``monthly 
pay'' includes special pay received under chapter 5 of title 37 
of the United States Code.
    (2) In the case of a member of the Corps who is directly 
engaged in the delivery of health services in a health 
professional shortage area in accordance with a service 
obligation incurred under the Scholarship Program or the Loan 
Repayment Program, the adjustment in pay authorized by 
paragraph (1) may be made for such a member only upon 
satisfactory completion of such service obligation, and the 
first 36 months of such member's being so engaged in the 
delivery of health services shall, for purposes of paragraph 
(1)(A), be deemed to begin upon such satisfactory completion.
    (3) A member of the Corps described in subparagraph (C) of 
subsection (a)(1) shall when assigned to an entity under 
section 333 be subject to the personnel system of such entity, 
except that such member shall receive during the period of 
assignment the income that the member would receive if the 
member was a member of the Corps described in subparagraph (B) 
of such subsection.
    (e) Corps members assigned under section 333 to provide 
health services in health professional shortage areas shall not 
be counted against any employment ceiling affecting the 
Department.
    (f) Sections 214 and 216 shall not apply to members of the 
National Health Service Corps during their period of obligated 
service under the Scholarship Program or the Loan Repayment 
Program, except when such members are Commissioned Corps 
officers who entered into a contract with Secretary under 
section 338A or 338B after December 31, 2006 and when the 
Secretary determines that exercising the authority provided 
under section 214 or 216 with respect to any such officer to 
would not cause unreasonable disruption to health care services 
provided in the community in which such officer is providing 
health care services.
    (g)(1) The Secretary shall, by rule, prescribe conversion 
provisions applicable to any individual who, within a year 
after completion of service as a member of the Corps described 
in subsection (a)(1)(C), becomes a commissioned officer in the 
Regular or Reserve Corps of the Service.
    (2) The rules prescribed under paragraph (1) shall provide 
that in applying the appropriate provisions of this Act which 
relate to retirement, any individual who becomes such an 
officer shall be entitled to have credit for any period of 
service as a member of the Corps described in subsection 
(a)(1)(C).
    (h) The Secretary shall ensure that adequate staff is 
provided to the Service with respect to effectively 
administering the program for the Corps.
    (i)(1) In carrying out subpart III, the Secretary may, in 
accordance with this subsection, issue waivers to individuals 
who have entered into a contract for obligated service under 
the Scholarship Program or the Loan Repayment Program under 
which the individuals are authorized to satisfy the requirement 
of obligated service through providing clinical practice that 
is half time.
    (2) A waiver described in paragraph (1) may be provided by 
the Secretary only if--
            (A) the entity for which the service is to be 
        performed--
                    (i) has been approved under section 333A 
                for assignment of a Corps member; and
                    (ii) has requested in writing assignment of 
                a health professional who would serve half 
                time;
            (B) the Secretary has determined that assignment of 
        a health professional who would serve half time would 
        be appropriate for the area where the entity is 
        located;
            (C) a Corps member who is required to perform 
        obligated service has agreed in writing to be assigned 
        for half-time service to an entity described in 
        subparagraph (A);
            (D) the entity and the Corps member agree in 
        writing that the Corps member will perform half-time 
        clinical practice;
            (E) the Corps member agrees in writing to fulfill 
        all of the service obligations under section 338C 
        through half-time clinical practice and either--
                    (i) double the period of obligated service 
                that would otherwise be required; or
                    (ii) in the case of contracts entered into 
                under section 338B, accept a minimum service 
                obligation of 2 years with an award amount 
                equal to 50 percent of the amount that would 
                otherwise be payable for full-time service; and
            (F) the Corps member agrees in writing that if the 
        Corps member begins providing half-time service but 
        fails to begin or complete the period of obligated 
        service, the method stated in 338E(c) for determining 
        the damages for breach of the individual's written 
        contract will be used after converting periods of 
        obligated service or of service performed into their 
        full-time equivalents.
    (3) In evaluating waivers issued under paragraph (1), the 
Secretary shall examine the effect of multidisciplinary teams.
    (j) For the purposes of this subpart and subpart III:
            (1) The term ``Department'' means the Department of 
        Health and Human Services.
            (2) The term ``Loan Repayment Program'' means the 
        National Health Service Corps Loan Repayment Program 
        established under section 338B.
            (3) The term ``Scholarship Program'' means the 
        National Health Service Corps Scholarship Program 
        established under section 338A.
            (4) The term ``State'' includes, in addition to the 
        several States, only the District of Columbia, the 
        Commonwealth of Puerto Rico, the Commonwealth of the 
        Northern Mariana Islands, the Virgin Islands, Guam, 
        American Samoa, and the Trust Territory of the Pacific 
        Islands.
            (5) The terms ``full time'' and ``full-time'' mean 
        a minimum of 40 hours per week in a clinical practice, 
        for a minimum of 45 weeks per year.
            (6) The terms ``half time'' and ``half-time'' mean 
        a minimum of 20 hours per week (not to exceed 39 hours 
        per week) in a clinical practice, for a minimum of 45 
        weeks per year.

           designation of health professional shortage areas

    Sec. 332. [254e] (a)(1) For purposes of this subpart the 
term ``health professional shortage area'' means (A) an area in 
an urban or rural area (which need not conform to the 
geographic boundaries of a political subdivision and which is a 
rational area for the delivery of health services) which the 
Secretary determines has a health manpower shortage, (B) a 
population group which the Secretary determines has such a 
shortage, or (C) a public or nonprofit private medical facility 
or other public facility which the Secretary determines has 
such a shortage. All Federally qualified health centers and 
rural health clinics, as defined in section 1861(aa) of the 
Social Security Act (42 U.S.C. 1395x(aa)), that meet the 
requirements of section 334 shall be automatically designated 
as having such a shortage. The Secretary shall not remove an 
area from the areas determined to be health professional 
shortage areas under subparagraph (A) of the preceding sentence 
until the Secretary has afforded interested persons and groups 
in such area an opportunity to provide data and information in 
support of the designation as a health professional shortage 
area or a population group described in subparagraph (B) of 
such sentence or a facility described in subparagraph (C) of 
such sentence, and has made a determination on the basis of the 
data and information submitted by such persons and groups and 
other data and information available to the Secretary.
    (2) For purposes of this subsection, the term ``medical 
facility'' means a facility for the delivery of health services 
and includes--
            (A) a hospital, State mental hospital, public 
        health center, outpatient medical facility, 
        rehabilitation facility, facility for long-term care, 
        community mental health center, migrant health center, 
        facility operated by a city or county health 
        department, and community health center and which is 
        not reasonably accessible to an adequately served area;
            (B) such a facility of a State correctional 
        institution or of the Indian Health Service, and a 
        health program or facility operated by a tribe or 
        tribal organization under the Indian Self-Determination 
        Act;
            (C) such a facility used in connection with the 
        delivery of health services under section 321 (relating 
        to hospitals), 322 (relating to care and treatment of 
        persons under quarantine and others), 323 (relating to 
        care and treatment of Federal prisoners), 324 (relating 
        to examination and treatment of certain Federal 
        employees), 325 (relating to examination of aliens), 
        326 (relating to services to certain Federal 
        employees), 320 (relating to services for persons with 
        Hansen's disease), or 330(h) (relating to the provision 
        of health services to homeless individuals); and
            (D) a Federal medical facility.
    (3) Homeless individuals (as defined in section 330(h)(5)), 
seasonal agricultural workers (as defined in section 330(g)(3)) 
and migratory agricultural workers (as so defined)), and 
residents of public housing (as defined in section 3(b)(1) of 
the United States Housing Act of 1937 (42 U.S.C. 1437a(b)(1))) 
may be population groups under paragraph (1).
    (b) The Secretary shall establish by regulation criteria 
for the designation of areas, population groups, medical 
facilities, and other public facilities, in the States, as 
health professional shortage areas. In establishing such 
criteria, the Secretary shall take into consideration the 
following:
            (1) The ratio of available health manpower to the 
        number of individuals in an area or population group, 
        or served by a medical facility or other public 
        facility under consideration for designation.
            (2) Indicators of a need, notwithstanding the 
        supply of health manpower, for health services for the 
        individuals in an area or population group or served by 
        a medical facility or other public facility under 
        consideration for designation.
            (3) The percentage of physicians serving an area, 
        population group, medical facility, or other public 
        facility under consideration for designation who are 
        employed by hospitals and who are graduates of foreign 
        medical schools.
    (c) In determining whether to make a designation, the 
Secretary shall take into consideration the following:
            (1) The recommendations of the Governor of each 
        State in which the area, population group, medical 
        facility, or other public facility under consideration 
        for designation is in whole or part located.
            (2) The extent to which individuals who are (A) 
        residents of the area, members of the population group, 
        or patients in the medical facility or other public 
        facility under consideration for designation, and (B) 
        entitled to have payment made for medical services 
        under title XVIII, XIX, or XXI of the Social Security 
        Act, cannot obtain such services because of suspension 
        of physicians from the programs under such titles.
    (d)(1) In accordance with the criteria established under 
subsection (b) and the considerations listed in subsection (c), 
the Secretary shall designate health professional shortage 
areas in the States, publish a descriptive list of the areas, 
population groups, medical facilities, and other public 
facilities so designated, and at least annually review and, as 
necessary, revise such designations.
    (2) For purposes of paragraph (1), a complete descriptive 
list shall be published in the Federal Register not later than 
July 1 of 1991 and each subsequent year.
    (e)(1) Prior to the designation of a public facility, 
including a Federal medical facility, as a health professional 
shortage area, the Secretary shall give written notice of such 
proposed designation to the chief administrative officer of 
such facility and request comments within 30 days with respect 
to such designation.
    (2) Prior to the designation of a health professional 
shortage area under this section, the Secretary shall, to the 
extent practicable, give written notice of the proposed 
designation of such area to appropriate public or private 
nonprofit entities which are located or have a demonstrated 
interest in such area and request comments from such entities 
with respect to the proposed designation of such area.
    (f) The Secretary shall give written notice of the 
designation of a health professional shortage area, not later 
than 60 days from the date of such designation, to--
            (1) the Governor of each State in which the area, 
        population group, medical facility, or other public 
        facility so designated is in whole or part located; and
            (2) appropriate public or nonprofit private 
        entities which are located or which have a demonstrated 
        interest in the area so designated.
    (g) Any person may recommend to the Secretary the 
designation of an area, population group, medical facility, or 
other public facility as a health professional shortage area.
    (h) The Secretary may conduct such information programs in 
areas, among population groups, and in medical facilities and 
other public facilities designated under this section as health 
professional shortage areas as may be necessary to inform 
public and nonprofit private entities which are located or have 
a demonstrated interest in such areas of the assistance 
available under this title by virtue of the designation of such 
areas.
    (i) Dissemination.--The Administrator of the Health 
Resources and Services Administration shall disseminate 
information concerning the designation criteria described in 
subsection (b) to--
            (1) the Governor of each State;
            (2) the representative of any area, population 
        group, or facility selected by any such Governor to 
        receive such information;
            (3) the representative of any area, population 
        group, or facility that requests such information; and
            (4) the representative of any area, population 
        group, or facility determined by the Administrator to 
        be likely to meet the criteria described in subsection 
        (b).
    (j)(1) The Secretary shall submit the report described in 
paragraph (2) if the Secretary, acting through the 
Administrator of the Health Resources and Services 
Administration, issues--
            (A) a regulation that revises the definition of a 
        health professional shortage area for purposes of this 
        section; or
            (B) a regulation that revises the standards 
        concerning priority of such an area under section 333A.
    (2) On issuing a regulation described in paragraph (1), the 
Secretary shall prepare and submit to the Committee on Energy 
and Commerce of the House of Representatives and the Committee 
on Health, Education, Labor, and Pensions of the Senate a 
report that describes the regulation.
    (3) Each regulation described in paragraph (1) shall take 
effect 180 days after the committees described in paragraph (2) 
receive a report referred to in such paragraph describing the 
regulation.

                     assignment of corps personnel

    Sec. 333. [254f] (a)(1) The Secretary may assign members of 
the Corps to provide, under regulations promulgated by the 
Secretary, health services in or to a health professional 
shortage area during the assignment period only if--
            (A) a public or private entity, which is located or 
        has a demonstrated interest in such area, makes 
        application to the Secretary for such assignment;
            (B) such application has been approved by the 
        Secretary;
            (C) the entity agrees to comply with the 
        requirements of section 334; and
            (D) the Secretary has (i) conducted an evaluation 
        of the need and demand for health professional shortage 
        area, the intended use of Corps members to be assigned 
        to the area, community support for the assignment of 
        Corps members to the area, the area's efforts to secure 
        health professional shortage area, and the fiscal 
        management capability of the entity to which Corps 
        members would be assigned and (ii) on the basis of such 
        evaluation has determined that--
                    (I) there is a need and demand for health 
                manpower for the area;
                    (II) there has been appropriate and 
                efficient use of any Corps members previously 
                assigned to the entity for the area;
                    (III) there is general community support 
                for the assignment of Corps members to the 
                entity;
                    (IV) the area has made unsuccessful efforts 
                to secure health manpower for the area;
                    (V) there is a reasonable prospect of sound 
                fiscal management, including efficient 
                collection of fee-for-service, third-party, and 
                other appropriate funds, by the entity with 
                respect to Corps members assigned to such 
                entity; and
                                    (VI) \1\ the entity 
                                demonstrates willingness to 
                                support or facilitate 
                                mentorship, professional 
                                development, and training 
                                opportunities for Corps 
                                members.
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    \1\ Margin so in law.
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An application for assignment of a Corps member to a health 
professional shortage area shall include a demonstration by the 
applicant that the area or population group to be served by the 
applicant has a shortage of personal health services and that 
the Corps member will be located so that the member will 
provide services to the greatest number of persons residing in 
such area or included in such population group. Such a 
demonstration shall be made on the basis of the criteria 
prescribed by the Secretary under section 332(b) and on 
additional criteria which the Secretary shall prescribe to 
determine if the area or population group to be served by the 
applicant has a shortage of personal health services.
    (2) Corps members may be assigned to a Federal health care 
facility, but only upon the request of the head of the 
department or agency of which such facility is a part.
    (3) In approving applications for assignment of members of 
the Corps the Secretary shall not discriminate against 
applications from entities which are not receiving Federal 
financial assistance under this Act. In approving such 
applications, the Secretary shall give preference to 
applications in which a nonprofit entity or public entity shall 
provide a site to which Corps members may be assigned.
    (b)(1) The Secretary may not approve an application for the 
assignment of a member of the Corps described in subparagraph 
(C) of section 331(a)(1) to an entity unless the application of 
the entity contains assurances satisfactory to the Secretary 
that the entity (A) has sufficient financial resources to 
provide the member of the Corps with an income of not less than 
the income to which the member would be entitled if the member 
was a member described in subparagraph (B) of section 
331(a)(1), or (B) would have such financial resources if a 
grant was made to the entity under paragraph (2).
    (2)(A) If in approving an application of an entity for the 
assignment of a member of the Corps described in subparagraph 
(C) of section 331(a)(1) the Secretary determines that the 
entity does not have sufficient financial resources to provide 
the member of the Corps with an income of not less than the 
income to which the member would be entitled if the member was 
a member described in subparagraph (B) of section 331(a)(1), 
the Secretary may make a grant to the entity to assure that the 
member of the Corps assigned to it will receive during the 
period of assignment to the entity such an income.
    (B) The amount of any grant under subparagraph (A) shall be 
determined by the Secretary. Payments under such a grant may be 
made in advance or by way of reimbursement, and at such 
intervals and on such conditions, as the Secretary finds 
necessary. No grant may be made unless an application therefor 
is submitted to and approved by the Secretary. Such an 
application shall be in such form, submitted in such manner, 
and contain such information, as the Secretary shall by 
regulation prescribe.
    (c) The Secretary shall assign Corps members to entities in 
health professional shortage areas without regard to the 
ability of the individuals in such areas, population groups, 
medical facilities, or other public facilities to pay for such 
services.
    (d)(1) The Secretary may provide technical assistance to a 
public or private entity which is located in a health 
professional shortage area and which desires to make an 
application under this section for assignment of a Corps member 
to such area. Assistance provided under this paragraph may 
include assistance to an entity in (A) analyzing the potential 
use of health professions personnel in defined health services 
delivery areas by the residents of such areas, (B) determining 
the need for such personnel in such areas, (C) determining the 
extent to which such areas will have a financial base to 
support the practice of such personnel and the extent to which 
additional financial resources are needed to adequately support 
the practice, (D) determining the types of inpatient and other 
health services that should be provided by such personnel in 
such areas, and (E) developing long-term plans for addressing 
health professional shortages and improving access to health 
care. The Secretary shall encourage entities that receive 
technical assistance under this paragraph to communicate with 
other communities, State Offices of Rural Health, State Primary 
Care Associations and Offices, and other entities concerned 
with site development and community needs assessment.
    (2) The Secretary may provide, to public and private 
entities which are located in a health professional shortage 
area to which area a Corps member has been assigned, technical 
assistance to assist in the retention of such member in such 
area after the completion of such member's assignment to the 
area.
    (3) The Secretary may provide, to health professional 
shortage areas to which no Corps member has been assigned, (A) 
technical assistance to assist in the recruitment of health 
manpower for such areas, and (B) current information on public 
and private programs which provide assistance in the securing 
of health manpower.
    (4)(A) The Secretary shall undertake to demonstrate the 
improvements that can be made in the assignment of members of 
the Corps to health professional shortage areas and in the 
delivery of health care by Corps members in such areas through 
coordination with States, political subdivisions of States, 
agencies of States and political subdivisions, and other public 
and private entities which have expertise in the planning, 
development, and operation of centers for the delivery of 
primary health care. In carrying out this subparagraph, the 
Secretary shall enter into agreements with qualified entities 
which provide that if--
            (i) the entity places in effect a program for the 
        planning, development, and operation of centers for the 
        delivery of primary health care in health professional 
        shortage areas which reasonably addresses the need for 
        such care in such areas, and
            (ii) under the program the entity will perform the 
        functions described in subparagraph (B),
the Secretary will assign under this section members of the 
Corps in accordance with the program.
    (B) For purposes of subparagraph (A), the term ``qualified 
entity'' means a State, political subdivision of a State, an 
agency of a State or political subdivision, or other public or 
private entity operating solely within one State, which the 
Secretary determines is able--
            (i) to analyze the potential use of health 
        professions personnel in defined health services 
        delivery areas by the residents of such areas;
            (ii) to determine the need for such personnel in 
        such areas and to recruit, select, and retain health 
        professions personnel (including members of the 
        National Health Service Corps) to meet such need;
            (iii) to determine the extent to which such areas 
        will have a financial base to support the practice of 
        such personnel and the extent to which additional 
        financial resources are needed to adequately support 
        the practice;
            (iv) to determine the types of inpatient and other 
        health services that should be provided by such 
        personnel in such areas;
            (v) to assist such personnel in the development of 
        their clinical practice and fee schedules and in the 
        management of their practice;
            (vi) to assist in the planning and development of 
        facilities for the delivery of primary health care; and
            (vii) to assist in establishing the governing 
        bodies of centers for the delivery of such care and to 
        assist such bodies in defining and carrying out their 
        responsibilities.
    (e) Notwithstanding any other law, any member of the Corps 
licensed to practice medicine, osteopathic medicine, dentistry, 
or any other health profession in any State shall, while 
serving in the Corps, be allowed to practice such profession in 
any State.

SEC. 333A. [254F-1] PRIORITIES IN ASSIGNMENT OF CORPS PERSONNEL.

    (a) In General.--In approving applications made under 
section 333 for the assignment of Corps members, the Secretary 
shall--
            (1) give priority to any such application that--
                    (A) is made regarding the provision of 
                primary health services to a health 
                professional shortage area with the greatest 
                such shortage; and
                    (B) is made by an entity that--
                            (i) serves a health professional 
                        shortage area described in subparagraph 
                        (A);
                            (ii) coordinates the delivery of 
                        primary health services with related 
                        health and social services;
                            (iii) has a documented record of 
                        sound fiscal management; and
                            (iv) will experience a negative 
                        impact on its capacity to provide 
                        primary health services if a Corps 
                        member is not assigned to the entity;
            (2) with respect to the geographic area in which 
        the health professional shortage area is located, take 
        into consideration the willingness of individuals in 
        the geographic area, and of the appropriate 
        governmental agencies or health entities in the area, 
        to assist and cooperate with the Corps in providing 
        effective primary health services; and
            (3) take into consideration comments of medical, 
        osteopathic, dental, or other health professional 
        societies whose members deliver services to the health 
        professional shortage area, or if no such societies 
        exist, comments of physicians, dentists, or other 
        health professionals delivering services to the area.
    (b) Establishment of Criteria for Determining Priorities.--
            (1) In general.--The Secretary shall establish 
        criteria specifying the manner in which the Secretary 
        makes a determination under subsection (a)(1)(A) of the 
        health professional shortage areas with the greatest 
        such shortages.
            (2) Publication of criteria.--The criteria required 
        in paragraph (1) shall be published in the Federal 
        Register not later than July 1, 1991. Any revisions 
        made in the criteria by the Secretary shall be 
        effective upon publication in the Federal Register.
    (c) Notifications Regarding Priorities.--
            (1) Proposed list.--The Secretary shall prepare and 
        publish a proposed list of health professional shortage 
        areas and entities that would receive priority under 
        subsection (a)(1) in the assignment of Corps members. 
        The list shall contain the information described in 
        paragraph (2), and the relative scores and relative 
        priorities of the entities submitting applications 
        under section 333, in a proposed format. All such 
        entities shall have 30 days after the date of 
        publication of the list to provide additional data and 
        information in support of inclusion on the list or in 
        support of a higher priority determination and the 
        Secretary shall reasonably consider such data and 
        information in preparing the final list under paragraph 
        (2).
            (2) Preparation of list for applicable period.--For 
        the purpose of carrying out paragraph (3), the 
        Secretary shall prepare and, as appropriate, update a 
        list of health professional shortage areas and entities 
        that are receiving priority under subsection (a)(1) in 
        the assignment of Corps members. Such list--
                    (A) shall include a specification, for each 
                such health professional shortage area, of the 
                entities for which the Secretary has provided 
                an authorization to receive assignments of 
                Corps members in the event that Corps members 
                are available for the assignments; and
                    (B) shall, of the entities for which an 
                authorization described in subparagraph (A) has 
                been provided, specify--
                            (i) the entities provided such an 
                        authorization for the assignment of 
                        Corps members who are participating in 
                        the Scholarship Program;
                            (ii) the entities provided such an 
                        authorization for the assignment of 
                        Corps members who are participating in 
                        the Loan Repayment Program; and
                            (iii) the entities provided such an 
                        authorization for the assignment of 
                        Corps members who have become Corps 
                        members other than pursuant to 
                        contractual obligations under the 
                        Scholarship or Loan Repayment Programs.

                The Secretary may set forth such specifications 
                by medical specialty.
            (3) Notification of affected parties.--
                    (A) Entities.--Not later than 30 days after 
                the Secretary has added to a list under 
                paragraph (2) an entity specified as described 
                in subparagraph (A) of such paragraph, the 
                Secretary shall notify such entity that the 
                entity has been provided an authorization to 
                receive assignments of Corps members in the 
                event that Corps members are available for the 
                assignments.
                    (B) Individuals.--In the case of an 
                individual obligated to provide service under 
                the Scholarship Program, not later than 3 
                months before the date described in section 
                338C(b)(5), the Secretary shall provide to such 
                individual the names of each of the entities 
                specified as described in paragraph (2)(B)(i) 
                that is appropriate for the individual's 
                medical specialty and discipline.
            (4) Revisions.--If the Secretary proposes to make a 
        revision in the list under paragraph (2), and the 
        revision would adversely alter the status of an entity 
        with respect to the list, the Secretary shall notify 
        the entity of the revision. Any entity adversely 
        affected by such a revision shall be notified in 
        writing by the Secretary of the reasons for the 
        revision and shall have 30 days from such notification 
        to file a written appeal of the determination involved 
        which shall be reasonably considered by the Secretary 
        before the revision to the list becomes final. The 
        revision to the list shall be effective with respect to 
        assignment of Corps members beginning on the date that 
        the revision becomes final.
    (d) Limitation on Number of Entities Offered as Assignment 
Choices in Scholarship Program.--
            (1) Determination of available corps members.--By 
        April 1 of each calendar year, the Secretary shall 
        determine the number of participants in the Scholarship 
        Program who will be available for assignments under 
        section 333 during the program year beginning on July 1 
        of that calendar year.
            (2) Determination of number of entities.--At all 
        times during a program year, the number of entities 
        specified under subsection (c)(2)(B)(i) shall be--
                    (A) not less than the number of 
                participants determined with respect to that 
                program year under paragraph (1); and
                    (B) not greater than twice the number of 
                participants determined with respect to that 
                program year under paragraph (1).

SEC. 334. [254G] CHARGES FOR SERVICES BY ENTITIES USING CORPS MEMBERS.

    (a) Availability of Services Regardless of Ability To Pay 
or Payment Source.--An entity to which a Corps member is 
assigned shall not deny requested health care services, and 
shall not discriminate in the provision of services to an 
individual--
            (1) because the individual is unable to pay for the 
        services; or
            (2) because payment for the services would be made 
        under--
                    (A) the medicare program under title XVIII 
                of the Social Security Act (42 U.S.C. 1395 et 
                seq.);
                    (B) the medicaid program under title XIX of 
                such Act (42 U.S.C. 1396 et seq.); or
                    (C) the State children's health insurance 
                program under title XXI of such Act (42 U.S.C. 
                1397aa et seq.).
    (b) Charges for Services.--The following rules shall apply 
to charges for health care services provided by an entity to 
which a Corps member is assigned:
            (1) In general.--
                    (A) Schedule of fees or payments.--Except 
                as provided in paragraph (2), the entity shall 
                prepare a schedule of fees or payments for the 
                entity's services, consistent with locally 
                prevailing rates or charges and designed to 
                cover the entity's reasonable cost of 
                operation.
                    (B) Schedule of discounts.--Except as 
                provided in paragraph (2), the entity shall 
                prepare a corresponding schedule of discounts 
                (including, in appropriate cases, waivers) to 
                be applied to the payment of such fees or 
                payments. In preparing the schedule, the entity 
                shall adjust the discounts on the basis of a 
                patient's ability to pay.
                    (C) Use of schedules.--The entity shall 
                make every reasonable effort to secure from 
                patients fees and payments for services in 
                accordance with such schedules, and fees or 
                payments shall be sufficiently discounted in 
                accordance with the schedule described in 
                subparagraph (B).
            (2) Services to beneficiaries of federal and 
        federally assisted programs.--In the case of health 
        care services furnished to an individual who is a 
        beneficiary of a program listed in subsection (a)(2), 
        the entity--
                    (A) shall accept an assignment pursuant to 
                section 1842(b)(3)(B)(ii) of the Social 
                Security Act (42 U.S.C. 1395u(b)(3)(B)(ii)) 
                with respect to an individual who is a 
                beneficiary under the medicare program; and
                    (B) shall enter into an appropriate 
                agreement with--
                            (i) the State agency administering 
                        the program under title XIX of such Act 
                        with respect to an individual who is a 
                        beneficiary under the medicaid program; 
                        and
                            (ii) the State agency administering 
                        the program under title XXI of such Act 
                        with respect to an individual who is a 
                        beneficiary under the State children's 
                        health insurance program.
            (3) Collection of payments.--The entity shall take 
        reasonable and appropriate steps to collect all 
        payments due for health care services provided by the 
        entity, including payments from any third party 
        (including a Federal, State, or local government agency 
        and any other third party) that is responsible for part 
        or all of the charge for such services.
             provision of health services by corps members
    Sec. 335. [254h] (a) In providing health services in a 
health professional shortage area, Corps members shall utilize 
the techniques, facilities, and organizational forms most 
appropriate for the area, population group, medical facility, 
or other public facility, and shall, to the maximum extent 
feasible, provide such services (1) to all individuals in, or 
served by, such health professional shortage area regardless of 
their ability to pay for the services, and (2) in a manner 
which is cooperative with other health care providers serving 
such health professional shortage area.
    (b)(1) Notwithstanding any other provision of law, the 
Secretary may (A) to the maximum extent feasible make such 
arrangements as he determines necessary to enable Corps members 
to utilize the health facilities in or serving the health 
professional shortage area in providing health services; (B) 
make such arrangements as he determines are necessary for the 
use of equipment and supplies of the Service and for the lease 
or acquisition of other equipment and supplies; and (C) secure 
the permanent or temporary services of physicians, dentists, 
nurses, administrators, and other health personnel. If there 
are no health facilities in or serving such area, the Secretary 
may arrange to have Corps members provide health services in 
the nearest health facilities of the Service or may lease or 
otherwise provide facilities in or serving such area for the 
provision of health services.
    (2) If the individuals in or served by a health 
professional shortage area are being served (as determined 
under regulations of the Secretary) by a hospital or other 
health care delivery facility of the Service, the Secretary 
may, in addition to such other arrangements as he may make 
under paragraph (1), arrange for the utilization of such 
hospital or facility by Corps members in providing health 
services, but only to the extent that such utilization will not 
impair the delivery of health services and treatment through 
such hospital or facility to individuals who are entitled to 
health services and treatment through such hospital or 
facility.
    (c) The Secretary may make one loan to any entity with an 
approved application under section 333 to assist such entity in 
meeting the costs of (1) establishing medical, dental, or other 
health profession practices, including the development of 
medical practice management systems; (2) acquiring equipment 
for use in providing health services; and (3) renovating 
buildings to establish health facilities. No loan may be made 
under this subsection unless an application therefor is 
submitted to, and approved by, the Secretary. The amount of any 
such loan shall be determined by the Secretary, except that no 
such loan may exceed $50,000.
    (d) Upon the expiration of the assignment of all Corps 
members to a health professional shortage area, the Secretary 
may (notwithstanding any other provision of law) sell, to any 
appropriate local entity, equipment and other property of the 
United States utilized by such members in providing health 
services. Sales made under this subsection shall be made at the 
fair market value (as determined by the Secretary) of the 
equipment or such other property; except that the Secretary may 
make such sales for a lesser value to an appropriate local 
entity, if he determines that the entity is financially unable 
to pay the full market value.
    (e)(1)(A) It shall be unlawful for any hospital to deny an 
authorized Corps member admitting privileges when such Corps 
member otherwise meets the professional qualifications 
established by the hospital for granting such privileges and 
agrees to abide by the published bylaws of the hospital and the 
published bylaws, rules, and regulations of its medical staff.
    (B) Any hospital which is found by the Secretary, after 
notice and an opportunity for a hearing on the record, to have 
violated this subsection shall upon such finding cease, for a 
period to be determined by the Secretary, to receive and to be 
eligible to receive any Federal funds under this Act or under 
titles XVIII, XIX, or XXI of the Social Security Act.
    (2) For purposes of this subsection, the term ``hospital'' 
includes a State or local public hospital, a private profit 
hospital, a private nonprofit hospital, a general or special 
hospital, and any other type of hospital (excluding a hospital 
owned or operated by an agency of the Federal Government), and 
any related facilities.

SEC. 336. [254H-1] FACILITATION OF EFFECTIVE PROVISION OF CORPS 
                    SERVICES.

    (a) Consideration of Individual Characteristics of Members 
in Making Assignments.--In making an assignment of a Corps 
member to an entity that has had an application approved under 
section 333, the Secretary shall, subject to making the 
assignment in accordance with section 333A, seek to assign to 
the entity a Corps member who has (and whose spouse, if any, 
has) characteristics that increase the probability that the 
member will remain in the health professional shortage area 
involved after the completion of the period of service in the 
Corps.
    (b) Counseling on Service in Corps.--
            (1) In general.--The Secretary shall, subject to 
        paragraph (3), offer appropriate counseling on service 
        in the Corps to individuals during the period of 
        membership in the Corps, particularly during the 
        initial period of each assignment.
            (2) Career advisor regarding obligated service.--
                    (A) In the case of individuals who have 
                entered into contracts for obligated service 
                under the Scholarship or Loan Repayment 
                Program, counseling under paragraph (1) shall 
                include appropriate counseling on matters 
                particular to such obligated service. The 
                Secretary shall ensure that career advisors for 
                providing such counseling are available to such 
                individuals throughout the period of 
                participation in the Scholarship or Loan 
                Repayment Program.
                    (B) With respect to the Scholarship 
                Program, counseling under paragraph (1) shall 
                include counseling individuals during the 
                period in which the individuals are pursuing an 
                educational degree in the health profession 
                involved, including counseling to prepare the 
                individual for service in the Corps.
            (3) Extent of counseling services.--With respect to 
        individuals who have entered into contracts for 
        obligated service under the Scholarship or Loan 
        Repayment Program, this subsection shall be carried out 
        regarding such individuals throughout the period of 
        obligated service (and, additionally, throughout the 
        period specified in paragraph (2)(B), in the case of 
        the Scholarship Program). With respect to Corps members 
        generally, this subsection shall be carried out to the 
        extent practicable.
    (c) Grants Regarding Preparation of Students for 
Practice.--With respect to individuals who have entered into 
contracts for obligated service under the Scholarship or Loan 
Repayment Program, the Secretary may make grants to, and enter 
into contracts with, public and nonprofit private entities 
(including health professions schools) for the conduct of 
programs designed to prepare such individuals for the effective 
provision of primary health services in the health professional 
shortage areas to which the individuals are assigned.
    (d) Professional Development and Training.--
            (1) In general.--The Secretary shall assist Corps 
        members in establishing and maintaining professional 
        relationships and development opportunities, including 
        by--
                    (A) establishing appropriate professional 
                relationships between the Corps member involved 
                and the health professions community of the 
                geographic area with respect to which the 
                member is assigned;
                    (B) establishing professional development, 
                training, and mentorship linkages between the 
                Corps member involved and the larger health 
                professions community, including through 
                distance learning, direct mentorship, and 
                development and implementation of training 
                modules designed to meet the educational needs 
                of offsite Corps members;
                    (C) establishing professional networks 
                among Corps members; or
                    (D) engaging in other professional 
                development, mentorship, and training 
                activities for Corps members, at the discretion 
                of the Secretary.
            (2) Assistance in establishing professional 
        relationships.--In providing such assistance under 
        paragraph (1), the Secretary shall focus on 
        establishing relationships with hospitals, with 
        academic medical centers and health professions 
        schools, with area health education centers under 
        section 751, with health education and training centers 
        under section 752, and with border health education and 
        training centers under such section 752. Such 
        assistance shall include assistance in obtaining 
        faculty appointments at health professions schools.
            (3) Supplement not supplant.--Such efforts under 
        this subsection shall supplement, not supplant, non-
        government efforts by professional health provider 
        societies to establish and maintain professional 
        relationships and development opportunities.
    (e) Temporary Relief From Corps Duties.--
            (1) In general.--The Secretary shall, subject to 
        paragraph (4), provide assistance to Corps members in 
        establishing arrangements through which Corps members 
        may, as appropriate, be provided temporary relief from 
        duties in the Corps in order to pursue continuing 
        education in the health professions, to participate in 
        exchange programs with teaching centers, to attend 
        professional conferences, or to pursue other interests, 
        including vacations.
            (2) Assumption of duties of member.--
                    (A) Temporary relief under paragraph (1) 
                may be provided only if the duties of the Corps 
                member involved are assumed by another health 
                professional. With respect to such temporary 
                relief, the duties may be assumed by Corps 
                members or by health professionals who are not 
                Corps members, if the Secretary approves the 
                professionals for such purpose. Any health 
                professional so approved by the Secretary 
                shall, during the period of providing such 
                temporary relief, be deemed to be a Corps 
                member for purposes of section 224 (including 
                for purposes of the remedy described in such 
                section), section 333(f) \1\, and section 
                335(e).
---------------------------------------------------------------------------
    \1\ So in law. As a result of the amendments made by section 103(b) 
of Public Law 101-597 (104 Stat. 3015), there is no subsection (f) in 
section 333. (Subsection (e) of section 333, like sections 224 and 
335(e), establishes a right for Corps members.)
---------------------------------------------------------------------------
                    (B) In carrying out paragraph (1), the 
                Secretary shall provide for the formation and 
                continued existence of a group of health 
                professionals to provide temporary relief under 
                such paragraph.
            (3) Recruitment from general health professions 
        community.--In carrying out paragraph (1), the 
        Secretary shall--
                    (A) encourage health professionals who are 
                not Corps members to enter into arrangements 
                under which the health professionals 
                temporarily assume the duties of Corps members 
                for purposes of paragraph (1); and
                    (B) with respect to the entities to which 
                Corps members have been assigned under section 
                333, encourage the entities to facilitate the 
                development of arrangements described in 
                subparagraph (A).
            (4) Limitation.--In carrying out paragraph (1), the 
        Secretary may not, except as provided in paragraph (5), 
        obligate any amounts (other than for incidental 
        expenses) for the purpose of--
                    (A) compensating a health professional who 
                is not a Corps member for assuming the duties 
                of a Corps member; or
                    (B) paying the costs of a vacation, or 
                other interests that a Corps member may pursue 
                during the period of temporary relief under 
                such paragraph.
            (5) Sole providers of health services.--In the case 
        of any Corps member who is the sole provider of health 
        services in the geographic area involved, the Secretary 
        may, from amounts appropriated under section 338, 
        obligate on behalf of the member such sums as the 
        Secretary determines to be necessary for purposes of 
        providing temporary relief under paragraph (1).
    (f) Determinations Regarding Effective Service.--In 
carrying out subsection (a) and sections 338A(d) and 338B(d), 
the Secretary shall carry out activities to determine--
            (1) the characteristics of physicians, dentists, 
        and other health professionals who are more likely to 
        remain in practice in health professional shortage 
        areas after the completion of the period of service in 
        the Corps;
            (2) the characteristics of health manpower shortage 
        areas \1\, and of entities seeking assignments of Corps 
        members, that are more likely to retain Corps members 
        after the members have completed the period of service 
        in the Corps; and
---------------------------------------------------------------------------
    \1\ So in law. Probably should be ``health professional shortage 
areas''. See section 401 of Public Law 101-597 (104 Stat. 3035).
---------------------------------------------------------------------------
            (3) the appropriate conditions for the assignment 
        and utilization in health manpower shortage areas \1\ 
        of certified nurse practitioners, certified nurse 
        midwives, and physician assistants.
                             annual reports
    Sec. 336A. [254i] The Secretary shall submit an annual 
report to Congress, and shall include in such report with 
respect to the previous calendar year--
            (1) the number, identity, and priority of all 
        health professional shortage areas designated in such 
        year and the number of health professional shortage 
        areas which the Secretary estimates will be designated 
        in the subsequent year;
            (2) the number of applications filed under section 
        333 in such year for assignment of Corps members and 
        the action taken on each such application;
            (3) the number and types of Corps members assigned 
        in such year to health professional shortage areas, the 
        number and types of additional Corps members which the 
        Secretary estimates will be assigned to such areas in 
        the subsequent year, and the need for additional 
        members for the Corps;
            (4) the recruitment efforts engaged in for the 
        Corps in such year and the number of qualified 
        individuals who applied for service in the Corps in 
        such year;
            (5) the number of patients seen and the number of 
        patient visits recorded during such year with respect 
        to each health professional shortage area to which a 
        Corps member was assigned during such year;
            (6) the number of Corps members who elected, and 
        the number of Corps members who did not elect, to 
        continue to provide health services in health 
        professional shortage areas after termination of their 
        service in the Corps and the reasons (as reported to 
        the Secretary) of members who did not elect for not 
        making such election;
            (7) the results of evaluations and determinations 
        made under section 333(a)(1)(D) during such year; and
            (8) the amount charged during such year for health 
        services provided by Corps members, the amount which 
        was collected in such year by entities in accordance 
        with section 334, and the amount which was paid to the 
        Secretary in such year under such agreements \1\.
---------------------------------------------------------------------------
    \1\ There is no antecedent reference to ``agreements''. Formerly, 
paragraph (8) contained the clause ``, the amount which was collected 
in such year by entities in accordance with agreements under section 
334,''. Section 307(b) of Public Law 107-251 (116 Stat. 1649) struck 
``agreements under'' in that clause.
---------------------------------------------------------------------------
                       national advisory council
    Sec. 337. [254j] (a) There is established a council to be 
known as the National Advisory Council on the National Health 
Service Corps (hereinafter in this section referred to as the 
``Council''). The Council shall be composed of fifteen members 
appointed by the Secretary. The Council shall consult with, 
advise, and make recommendations to, the Secretary with respect 
to his responsibilities in carrying out this subpart (other 
than section 338G), and shall review and comment upon 
regulations promulgated by the Secretary under this subpart.
    (b)(1) Members of the Council shall be appointed for a term 
of three years, except that any member appointed to fill a 
vacancy occurring prior to the expiration of the term for which 
the member's predecessor was appointed shall be appointed for 
the remainder of such term. No member shall be removed, except 
for cause.
    (2) Members of the Council (other than members who are 
officers or employees of the United States), while attending 
meetings or conferences thereof or otherwise serving on the 
business of the Council, shall be entitled to receive for each 
day (including traveltime) in which they are so serving 
compensation at a rate fixed by the Secretary (but not to 
exceed the daily equivalent of the annual rate of basic pay in 
effect for grade GS-18 of the General Schedule); and while so 
serving away from their homes or regular places of business all 
members may be allowed travel expenses, including per diem in 
lieu of subsistence, as authorized by section 5703 of title 5 
of the United States Code for persons in the Government service 
employed intermittently.
    (c) Section 14 of the Federal Advisory Committee Act shall 
not apply with respect to the Council.
                     authorization of appropriation
    Sec. 338. [254k] (a) For the purpose of carrying out this 
subpart, there are authorized to be appropriated such sums as 
may be necessary for each of the fiscal years 2008 through 
2012.
    (b) An appropriation under an authorization under 
subsection (a) for any fiscal year may be made at any time 
before that fiscal year and may be included in an Act making an 
appropriation under an authorization under subsection (a) for 
another fiscal year; but no funds may be made available from 
any appropriation under such authorization for obligation under 
sections 331 through 335, section 336A, and section 337 before 
the fiscal year for which such appropriation is authorized.

      Subpart III--Scholarship Program and Loan Repayment Program

           national health service corps scholarship program
    Sec. 338A. [254l] (a) The Secretary shall establish the 
National Health Service Corps Scholarship Program to assure, 
with respect to the provision of primary health services 
pursuant to section 331(a)(2)--
            (1) an adequate supply of physicians, dentists, 
        behavioral and mental health professionals, certified 
        nurse midwives, certified nurse practitioners, and 
        physician assistants; and
            (2) if needed by the Corps, an adequate supply of 
        other health professionals.
    (b) To be eligible to participate in the Scholarship 
Program, an individual must--
            (1) be accepted for enrollment, or be enrolled, as 
        a full-time student (A) in an accredited (as determined 
        by the Secretary) educational institution in a State 
        and (B) in a course of study or program, offered by 
        such institution and approved by the Secretary, leading 
        to a degree in medicine, osteopathic medicine, 
        dentistry, or other health profession, or an 
        appropriate degree from a graduate program of 
        behavioral and mental health;
            (2) be eligible for, or hold, an appointment as a 
        commissioned officer in the Regular or Reserve Corps of 
        the Service or be eligible for selection for civilian 
        service in the Corps;
            (3) submit an application to participate in the 
        Scholarship Program; and
            (4) sign and submit to the Secretary, at the time 
        of submittal of such application, a written contract 
        (described in subsection (f)) to accept payment of a 
        scholarship and to serve (in accordance with this 
        subpart) for the applicable period of obligated service 
        in a health professional shortage area.
    (c)(1) In disseminating application forms and contract 
forms to individuals desiring to participate in the Scholarship 
Program, the Secretary shall include with such forms--
            (A) a fair summary of the rights and liabilities of 
        an individual whose application is approved (and whose 
        contract is accepted) by the Secretary, including in 
        the summary a clear explanation of the damages to which 
        the United States is entitled under section 338E in the 
        case of the individual's breach of the contract; and
            (B) information respecting meeting a service 
        obligation through private practice under an agreement 
        under section 338D and such other information as may be 
        necessary for the individual to understand the 
        individual's prospective participation in the 
        Scholarship Program and service in the Corps, including 
        a statement of all factors considered in approving 
        applications for participation in the Program and in 
        making assignments for participants in the Program.
    (2) The application form, contract form, and all other 
information furnished by the Secretary under this subpart shall 
be written in a manner calculated to be understood by the 
average individual applying to participate in the Scholarship 
Program. The Secretary shall make such application forms, 
contract forms, and other information available to individuals 
desiring to participate in the Scholarship Program on a date 
sufficiently early to insure that such individuals have 
adequate time to carefully review and evaluate such forms and 
information.
    (3)(A) The Secretary shall distribute to health professions 
schools materials providing information on the Scholarship 
Program and shall encourage the schools to disseminate the 
materials to the students of the schools.
    (B)(i) In the case of any health professional whose period 
of obligated service under the Scholarship Program is nearing 
completion, the Secretary shall encourage the individual to 
remain in a health professional shortage area and to continue 
providing primary health services.
    (ii) During the period in which a health professional is 
planning and making the transition to private practice from 
obligated service under the Scholarship Program, the Secretary 
may provide assistance to the professional regarding such 
transition if the professional is remaining in a health 
professional shortage area and is continuing to provide primary 
health services.
    (C) In the case of entities to which participants in the 
Scholarship Program are assigned under section 333, the 
Secretary shall encourage the entities to provide options with 
respect to assisting the participants in remaining in the 
health professional shortage areas involved, and in continuing 
to provide primary health services, after the period of 
obligated service under the Scholarship Program is completed. 
The options with respect to which the Secretary provides such 
encouragement may include options regarding the sharing of a 
single employment position in the health professions by 2 or 
more health professionals, and options regarding the 
recruitment of couples where both of the individuals are health 
professionals.
    (d)(1) Subject to section 333A, in providing contracts 
under the Scholarship Program--
            (A) the Secretary shall consider the extent of the 
        demonstrated interest of the applicants for the 
        contracts in providing primary health services;
            (B) the Secretary, in considering applications from 
        individuals accepted for enrollment or enrolled in 
        dental school, shall consider applications from all 
        individuals accepted for enrollment or enrolled in any 
        accredited dental school in a State; and
            (C) may consider such other factors regarding the 
        applicants as the Secretary determines to be relevant 
        to selecting qualified individuals to participate in 
        such Program.
    (2) In providing contracts under the Scholarship Program, 
the Secretary shall give priority--
            (A) first, to any application for such a contract 
        submitted by an individual who has previously received 
        a scholarship under this section or under section 758;
            (B) second, to any application for such a contract 
        submitted by an individual who has characteristics that 
        increase the probability that the individual will 
        continue to serve in a health professional shortage 
        area after the period of obligated service pursuant to 
        subsection (f) is completed; and
            (C) third, subject to subparagraph (B), to any 
        application for such a contract submitted by an 
        individual who is from a disadvantaged background.
    (e)(1) An individual becomes a participant in the 
Scholarship Program only upon the Secretary's approval of the 
individual's application submitted under subsection (b)(3) and 
the Secretary's acceptance of the contract submitted by the 
individual under subsection (b)(4).
    (2) The Secretary shall provide written notice to an 
individual promptly upon the Secretary's approving, under 
paragraph (1), of the individual's participation in the 
Scholarship Program.
    (f) The written contract (referred to in this subpart) 
between the Secretary and an individual shall contain--
            (1) an agreement that--
                    (A) subject to paragraph (2), the Secretary 
                agrees (i) to provide the individual with a 
                scholarship (described in subsection (g)) in 
                each such school year or years for a period of 
                years (not to exceed four school years) 
                determined by the individual, during which 
                period the individual is pursuing a course of 
                study described in subsection (b)(1)(B), and 
                (ii) to accept (subject to the availability of 
                appropriated funds for carrying out sections 
                331 through 335 and section 337) the individual 
                into the Corps (or for equivalent service as 
                otherwise provided in this subpart); and
                    (B) subject to paragraph (2), the 
                individual agrees--
                            (i) to accept provision of such a 
                        scholarship to the individual;
                            (ii) to maintain enrollment in a 
                        course of study described in subsection 
                        (b)(1)(B) until the individual 
                        completes the course of study;
                            (iii) while enrolled in such course 
                        of study, to maintain an acceptable 
                        level of academic standing (as 
                        determined under regulations of the 
                        Secretary by the educational 
                        institution offering such course of 
                        study);
                            (iv) if pursuing a degree from a 
                        school of medicine or osteopathic 
                        medicine, to complete a residency in a 
                        specialty that the Secretary determines 
                        is consistent with the needs of the 
                        Corps; and
                            (v) to serve for a time period 
                        (hereinafter in the subpart referred to 
                        as the ``period of obligated service'') 
                        equal to--
                                    (I) one year for each 
                                school year for which the 
                                individual was provided a 
                                scholarship under the 
                                Scholarship Program, or
                                    (II) two years,
                        whichever is greater, as a provider of 
                        primary health services in a health 
                        professional shortage area (designated 
                        under section 332) to which he is 
                        assigned by the Secretary as a member 
                        of the Corps, or as otherwise provided 
                        in this subpart;
            (2) a provision that any financial obligation of 
        the United States arising out of a contract entered 
        into under this subpart and any obligation of the 
        individual which is conditioned thereon, is contingent 
        upon funds being appropriated for scholarships under 
        this subpart and to carry out the purposes of sections 
        331 through 335 and sections 337 and 338;
            (3) a statement of the damages to which the United 
        States is entitled, under section 338E for the 
        individual's breach of the contract; and
            (4) such other statements of the rights and 
        liabilities of the Secretary and of the individual, not 
        inconsistent with the provisions of this subpart.
    (g)(1) A scholarship provided to a student for a school 
year under a written contract under the Scholarship Program 
shall consist of--
            (A) payment to, or (in accordance with paragraph 
        (2)) on behalf of, the student of the amount (except as 
        provided in section 711) of--
                    (i) the tuition of the student in such 
                school year; and
                    (ii) all other reasonable educational 
                expenses, including fees, books, and laboratory 
                expenses, incurred by the student in such 
                school year; and
            (B) payment to the student of a stipend of $400 per 
        month (adjusted in accordance with paragraph (3)) for 
        each of the 12 consecutive months beginning with the 
        first month of such school year.
    (2) The Secretary may contract with an educational 
institution, in which a participant in the Scholarship Program 
is enrolled, for the payment to the educational institution of 
the amounts of tuition and other reasonable educational 
expenses described in paragraph (1)(A). Payment to such an 
educational institution may be made without regard to section 
3648 of the Revised Statutes (31 U.S.C. 529).
    (3) The amount of the monthly stipend, specified in 
paragraph (1)(B) and as previously adjusted (if at all) in 
accordance with this paragraph, shall be increased by the 
Secretary for each school year ending in a fiscal year 
beginning after September 30, 1978, by an amount (rounded to 
the next highest multiple of $1) equal to the amount of such 
stipend multiplied by the overall percentage (under section 
5303 of title 5, United States Code) of the adjustment (if such 
adjustment is an increase) in the rates of pay under the 
General Schedule made effective in the fiscal year in which 
such school year ends.
    (h) Notwithstanding any other provision of law, individuals 
who have entered into written contracts with the Secretary 
under this section, while undergoing academic training, shall 
not be counted against any employment ceiling affecting the 
Department.

SEC. 338B. [254L-1] NATIONAL HEALTH SERVICE CORPS LOAN REPAYMENT 
                    PROGRAM.

    (a) Establishment.--The Secretary shall establish a program 
to be known as the National Health Service Corps Loan Repayment 
Program to assure, with respect to the provision of primary 
health services pursuant to section 331(a)(2)--
            (1) an adequate supply of physicians, dentists, 
        behavioral and mental health professionals, certified 
        nurse midwives, certified nurse practitioners, and 
        physician assistants; and
            (2) if needed by the Corps, an adequate supply of 
        other health professionals.
    (b) Eligibility.--To be eligible to participate in the Loan 
Repayment Program, an individual must--
            (1)(A) have a degree in medicine, osteopathic 
        medicine, dentistry, or another health profession, or 
        an appropriate degree from a graduate program of 
        behavioral and mental health, or be certified as a 
        nurse midwife, nurse practitioner, or physician 
        assistant;
            (B) be enrolled in an approved graduate training 
        program in medicine, osteopathic medicine, dentistry, 
        behavioral and mental health, or other health 
        profession; or
            (C) be enrolled as a full-time student--
                    (i) in an accredited (as determined by the 
                Secretary) educational institution in a State; 
                and
                    (ii) in the final year of a course of a 
                study or program, offered by such institution 
                and approved by the Secretary, leading to a 
                degree in medicine, osteopathic medicine, 
                dentistry, or other health profession;
            (2) be eligible for, or hold, an appointment as a 
        commissioned officer in the Regular or Reserve Corps of 
        the Service or be eligible for selection for civilian 
        service in the Corps; and
            (3) submit to the Secretary an application for a 
        contract described in subsection (f) (relating to the 
        payment by the Secretary of the educational loans of 
        the individual in consideration of the individual 
        serving for a period of obligated service).
    (c) Application, Contract, and Information Requirements.--
            (1) Summary and information.--In disseminating 
        application forms and contract forms to individuals 
        desiring to participate in the Loan Repayment Program, 
        the Secretary shall include with such forms--
                    (A) a fair summary of the rights and 
                liabilities of an individual whose application 
                is approved (and whose contract is accepted) by 
                the Secretary, including in the summary a clear 
                explanation of the damages to which the United 
                States is entitled under section 338E in the 
                case of the individual's breach of the 
                contract; and
                    (B) information respecting meeting a 
                service obligation through private practice 
                under an agreement under section 338D and such 
                other information as may be necessary for the 
                individual to understand the individual's 
                prospective participation in the Loan Repayment 
                Program and service in the Corps.
            (2) Understandability.--The application form, 
        contract form, and all other information furnished by 
        the Secretary under this subpart shall be written in a 
        manner calculated to be understood by the average 
        individual applying to participate in the Loan 
        Repayment Program.
            (3) Availability.--The Secretary shall make such 
        application forms, contract forms, and other 
        information available to individuals desiring to 
        participate in the Loan Repayment Program on a date 
        sufficiently early to ensure that such individuals have 
        adequate time to carefully review and evaluate such 
        forms and information.
            (4) Recruitment and retention.--
                    (A) The Secretary shall distribute to 
                health professions schools materials providing 
                information on the Loan Repayment Program and 
                shall encourage the schools to disseminate the 
                materials to the students of the schools.
                    (B)(i) In the case of any health 
                professional whose period of obligated service 
                under the Loan Repayment Program is nearing 
                completion, the Secretary shall encourage the 
                individual to remain in a health professional 
                shortage area and to continue providing primary 
                health services.
                    (ii) During the period in which a health 
                professional is planning and making the 
                transition to private practice from obligated 
                service under the Loan Repayment Program, the 
                Secretary may provide assistance to the 
                professional regarding such transition if the 
                professional is remaining in a health 
                professional shortage area and is
                continuing to provide primary health services.
                    (C) In the case of entities to which 
                participants in the Loan Repayment Program are 
                assigned under section 333, the Secretary shall 
                encourage the entities to provide options with 
                respect to assisting the participants in 
                remaining in the health professional shortage 
                areas involved, and in continuing to provide 
                primary health services, after the period of 
                obligated service under the Loan Repayment 
                Program is completed. The options with respect 
                to which the Secretary provides such 
                encouragement may include options regarding the 
                sharing of a single employment position in the 
                health professions by 2 or more health 
                professionals, and options regarding the 
                recruitment of couples where both of the 
                individuals are health professionals.
    (d)(1) Subject to section 333A, in providing contracts 
under the Loan Repayment Program--
            (A) the Secretary shall consider the extent of the 
        demonstrated interest of the applicants for the 
        contracts in providing primary health services; and
            (B) may consider such other factors regarding the 
        applicants as the Secretary determines to be relevant 
        to selecting qualified individuals to participate in 
        such Program.
    (2) In providing contracts under the Loan Repayment 
Program, the Secretary shall give priority--
            (A) to any application for such a contract 
        submitted by an individual whose training is in a 
        health profession or specialty determined by the 
        Secretary to be needed by the Corps;
            (B) to any application for such a contract 
        submitted by an individual who has (and whose spouse, 
        if any, has) characteristics that increase the 
        probability that the individual will continue to serve 
        in a health professional shortage area after the period 
        of obligated service pursuant to subsection (f) is 
        completed; and
            (C) subject to subparagraph (B), to any application 
        for such a contract submitted by an individual who is 
        from a disadvantaged background.
    (e) Approval Required for Participation.--An individual 
becomes a participant in the Loan Repayment Program only upon 
the Secretary and the individual entering into a written 
contract described in subsection (f).
    (f) Contents of Contracts.--The written contract (referred 
to in this subpart) between the Secretary and an individual 
shall contain--
            (1) an agreement that--
                    (A) subject to paragraph (3), the Secretary 
                agrees--
                            (i) to pay on behalf of the 
                        individual loans in accordance with 
                        subsection (g); and
                            (ii) to accept (subject to the 
                        availability of appropriated funds for 
                        carrying out sections 331 through 335 
                        and section 337) the individual into 
                        the Corps (or for equivalent service as 
                        otherwise provided in this subpart); 
                        and
                    (B) subject to paragraph (3), the 
                individual agrees--
                            (i) to accept loan payments on 
                        behalf of the individual;
                            (ii) in the case of an individual 
                        described in subsection (b)(1)(C), to 
                        maintain enrollment in a course of 
                        study or training described in such 
                        subsection until the individual 
                        completes the course of study or 
                        training;
                            (iii) in the case of an individual 
                        described in subsection (b)(1)(C), 
                        while enrolled in such course of study 
                        or training, to maintain an acceptable 
                        level of academic standing (as 
                        determined under regulations of the 
                        Secretary by the educational 
                        institution offering such course of 
                        study or training); and
                            (iv) to serve for a time period 
                        (hereinafter in this subpart referred 
                        to as the ``period of obligated 
                        service'') equal to 2 years or such 
                        longer period as the individual may 
                        agree to, as a provider of primary 
                        health services in a health 
                        professional shortage area (designated 
                        under section 332) to which such 
                        individual is assigned by the Secretary 
                        as a member of the Corps or released 
                        under section 338D;
            (2) a provision permitting the Secretary to extend 
        for such longer additional periods, as the individual 
        may agree to, the period of obligated service agreed to 
        by the individual under paragraph (1)(B)(iv), including 
        extensions resulting in an aggregate period of 
        obligated service in excess of 4 years;
            (3) a provision that any financial obligation of 
        the United States arising out of a contract entered 
        into under this subpart and any obligation of the 
        individual that is conditioned thereon, is contingent 
        on funds being appropriated for loan repayments under 
        this subpart and to carry out the purposes of sections 
        331 through 335 and sections 337 and 338;
            (4) a statement of the damages to which the United 
        States is entitled, under section 338E for the 
        individual's breach of the contract; and
            (5) such other statements of the rights and 
        liabilities of the Secretary and of the individual, not 
        inconsistent with this subpart.
    (g) Payments.--
            (1) In general.--A loan repayment provided for an 
        individual under a written contract under the Loan 
        Repayment Program shall consist of payment, in 
        accordance with paragraph (2), on behalf of the 
        individual of the principal, interest, and related 
        expenses on government and commercial loans received by 
        the individual regarding the undergraduate or graduate 
        education of the individual (or both), which loans were 
        made for--
                    (A) tuition expenses;
                    (B) all other reasonable educational 
                expenses, including fees, books, and laboratory 
                expenses, incurred by the individual; or
                    (C) reasonable living expenses as 
                determined by the Secretary.
            (2) Payments for years served.--
                    (A) In general.--For each year of obligated 
                service that an individual contracts to serve 
                under subsection (f) the Secretary may pay up 
                to $50,000, plus, beginning with fiscal year 
                2012, an amount determined by the Secretary on 
                an annual basis to reflect inflation, on behalf 
                of the individual for loans described in 
                paragraph (1). In making a determination of the 
                amount to pay for a year of such service by an 
                individual, the Secretary shall consider the 
                extent to which each such determination--
                            (i) affects the ability of the 
                        Secretary to maximize the number of 
                        contracts that can be provided under 
                        the Loan Repayment Program from the 
                        amounts appropriated for such 
                        contracts;
                            (ii) provides an incentive to serve 
                        in health professional shortage areas 
                        with the greatest such shortages; and
                            (iii) provides an incentive with 
                        respect to the health professional 
                        involved remaining in a health 
                        professional shortage area, and 
                        continuing to provide primary health 
                        services, after the completion of the 
                        period of obligated service under the 
                        Loan Repayment Program.
                    (B) Repayment schedule.--Any arrangement 
                made by the Secretary for the making of loan 
                repayments in accordance with this subsection 
                shall provide that any repayments for a year of 
                obligated service shall be made no later than 
                the end of the fiscal year in which the 
                individual completes such year of service.
            (3) Tax liability.--For the purpose of providing 
        reimbursements for tax liability resulting from 
        payments under paragraph (2) on behalf of an 
        individual--
                    (A) the Secretary shall, in addition to 
                such payments, make payments to the individual 
                in an amount equal to 39 percent of the total 
                amount of loan repayments made for the taxable 
                year involved; and
                    (B) may make such additional payments as 
                the Secretary determines to be appropriate with 
                respect to such purpose.
            (4) Payment schedule.--The Secretary may enter into 
        an agreement with the holder of any loan for which 
        payments are made under the Loan Repayment Program to 
        establish a schedule for the making of such payments.
    (h) Employment Ceiling.--Notwithstanding any other 
provision of law, individuals who have entered into written 
contracts with the Secretary under this section, while 
undergoing academic or other training, shall not be counted 
against any employment ceiling affecting the Department.

                           obligated service

    Sec. 338C. [254m] (a) Service in Full-time Clinical 
Practice.--Except as provided in section 338D, each individual 
who has entered into a written contract with the Secretary 
under section 338A or 338B shall provide service in the full-
time clinical practice of such individual's profession as a 
member of the Corps for the period of obligated service 
provided in such contract. The Secretary may treat teaching as 
clinical practice for up to 20 percent of such period of 
obligated service. Notwithstanding the preceding sentence, with 
respect to a member of the Corps participating in the teaching 
health centers graduate medical education program under section 
340H, for the purpose of calculating time spent in full-time 
clinical practice under this section, up to 50 percent of time 
spent teaching by such member may be counted toward his or her 
service obligation.
    (b)(1) If an individual is required under subsection (a) to 
provide service as specified in section 338A(f)(1)(B)(v) or 
338B(f)(1)(B)(iv) (hereinafter in this subsection referred to 
as ``obligated service''), the Secretary shall, not later than 
ninety days before the date described in paragraph (5), 
determine if the individual shall provide such service--
            (A) as a member of the Corps who is a commissioned 
        officer in the Regular or Reserve Corps of the Service 
        or who is a civilian employee of the United States, or
            (B) as a member of the Corps who is not such an 
        officer or employee,
and shall notify such individual of such determination.
    (2) If the Secretary determines that an individual shall 
provide obligated service as a member of the Corps who is a 
commissioned officer in the Service or a civilian employee of 
the United States, the Secretary shall, not later than sixty 
days before the date described in paragraph (5), provide such 
individual with sufficient information regarding the advantages 
and disadvantages of service as such a commissioned officer or 
civilian employee to enable the individual to make a decision 
on an informed basis. To be eligible to provide obligated 
service as a commissioned officer in the Service, an individual 
shall notify the Secretary, not later than thirty days before 
the date described in paragraph (5), of the individual's desire 
to provide such service as such an officer. If an individual 
qualifies for an appointment as such an officer, the Secretary 
shall, as soon as possible after the date described in 
paragraph (5), appoint the individual as a commissioned officer 
of the Regular or Reserve Corps of the Service and shall 
designate the individual as a member of the Corps.
    (3) If an individual provided notice by the Secretary under 
paragraph (2) does not qualify for appointment as a 
commissioned officer in the Service, the Secretary shall, as 
soon as possible after the date described in paragraph (5), 
appoint such individual as a civilian employee of the United 
States and designate the individual as a member of the Corps.
    (4) If the Secretary determines that an individual shall 
provide obligated service as a member of the Corps who is not 
an employee of the United States, the Secretary shall, as soon 
as possible after the date described in paragraph (5), 
designate such individual as a member of the Corps to provide 
such service.
    (5)(A) In the case of the Scholarship Program, the date 
referred to in paragraphs (1) through (4) shall be the date on 
which the individual completes the training required for the 
degree for which the individual receives the scholarship, 
except that--
            (i) for an individual receiving such a degree after 
        September 30, 2000, from a school of medicine or 
        osteopathic medicine, such date shall be the date the 
        individual completes a residency in a specialty that 
        the Secretary determines is consistent with the needs 
        of the Corps; and
            (ii) at the request of an individual, the Secretary 
        may, consistent with the needs of the Corps, defer such 
        date until the end of a period of time required for the 
        individual to complete advanced training (including an 
        internship or residency).
    (B) No period of internship, residency, or other advanced 
clinical training shall be counted toward satisfying a period 
of obligated service under this subpart.
    (C) In the case of the Loan Repayment Program, if an 
individual is required to provide obligated service under such 
Program, the date referred to in paragraphs (1) through (4)--
            (i) shall be the date determined under subparagraph 
        (A) in the case of an individual who is enrolled in the 
        final year of a course of study;
            (ii) shall, in the case of an individual who is 
        enrolled in an approved graduate training program in 
        medicine, osteopathic medicine, dentistry, or other 
        health profession, be the date the individual completes 
        such training program; and
            (iii) shall, in the case of an individual who has a 
        degree in medicine, osteopathic medicine, dentistry, or 
        other health profession and who has completed graduate 
        training, be the date the individual enters into an 
        agreement with the Secretary under section 338B.
    (c) An individual shall be considered to have begun serving 
a period of obligated service--
            (1) on the date such individual is appointed as an 
        officer in a Regular or Reserve Corps of the Service or 
        is designated as a member of the Corps under subsection 
        (b)(3) or (b)(4), or
            (2) in the case of an individual who has entered 
        into an agreement with the Secretary under section 
        338D, on the date specified in such agreement,
whichever is earlier.
    (d) The Secretary shall assign individuals performing 
obligated service in accordance with a written contract under 
the Scholarship Program to health professional shortage areas 
in accordance with sections 331 through 335 and sections 337 
and 338. If the Secretary determines that there is no need in a 
health professional shortage area (designated under section 
332) for a member of the profession in which an individual is 
obligated to provide service under a written contract and if 
such individual is an officer in the Service or a civilian 
employee of the United States, the Secretary may detail such 
individual to serve his period of obligated service as a full-
time member of such profession in such unit of the Department 
as the Secretary may determine.

                            private practice

    Sec. 338D. [254n] (a) The Secretary shall, to the extent 
permitted by, and consistent with, the requirements of 
applicable State law, release an individual from all or part of 
his service obligation under section 338C(a) or under section 
225 (as in effect on September 30, 1977) if the individual 
applies for such a release under this section and enters into a 
written agreement with the Secretary under which the individual 
agrees to engage for a period equal to the remaining period of 
his service obligation in the full-time private clinical 
practice (including service as a salaried employee in an entity 
directly providing health services) of his health profession--
            (1) in the case of an individual who received a 
        scholarship under the Scholarship Program or a loan 
        repayment under the Loan Repayment Program and who is 
        performing obligated service as a member of the Corps 
        in a health professional shortage area on the date of 
        his application for such a release, in the health 
        professional shortage area in which such individual is 
        serving on such date or in the case of an individual 
        for whom a loan payment was made under the Loan 
        Repayment Program and who is performing obligated 
        service as a member of the Corps in a health 
        professional shortage area on the date of the 
        application of the individual for such a release, in 
        the health professional shortage area selected by the 
        Secretary; or
            (2) in the case of any other individual, in a 
        health professional shortage area (designated under 
        section 332) selected by the Secretary.
    (b)(1) The written agreement described in subsection (a) 
shall--
            (A) provide that, during the period of private 
        practice by an individual pursuant to the agreement, 
        the individual shall comply with the requirements of 
        section 334 that apply to entities; and
            (B) contain such additional provisions as the 
        Secretary may require to carry out the objectives of 
        this section.
    (2) The Secretary shall take such action as may be 
appropriate to ensure that the conditions of the written 
agreement prescribed by this subsection are adhered to.
    (c) If an individual breaches the contract entered into 
under section 338A or 338B by failing (for any reason) to begin 
his service obligation in accordance with an agreement entered 
into under subsection (a) or to complete such service 
obligation, the Secretary may permit such individual to perform 
such service obligation as a member of the Corps.
    (d) The Secretary may pay an individual who has entered 
into an agreement with the Secretary under subsection (a) an 
amount to cover all or part of the individual's expenses 
reasonably incurred in transporting himself, his family, and 
his possessions to the location of his private clinical 
practice.
    (e) Upon the expiration of the written agreement under 
subsection (a), the Secretary may (notwithstanding any other 
provision of law) sell to the individual who has entered into 
an agreement with the Secretary under subsection (a), equipment 
and other property of the United States utilized by such 
individual in providing health services. Sales made under this 
subsection shall be made at the fair market value (as 
determined by the Secretary) of the equipment or such other 
property, except that the Secretary may make such sales for a 
lesser value to the individual if he determines that the 
individual is financially unable to pay the full market value.
    (f) The Secretary may, out of appropriations authorized 
under section 338, pay to individuals participating in private 
practice under this section the cost of such individual's 
malpractice insurance and the lesser of--
            (1)(A) $10,000 in the first year of obligated 
        service;
            (B) $7,500 in the second year of obligated service;
            (C) $5,000 in the third year of obligated service; 
        and
            (D) $2,500 in the fourth year of obligated service; 
        or
            (2) an amount determined by subtracting such 
        individual's net income before taxes from the income 
        the individual would have received as a member of the 
        Corps for each such year of obligated service.
    (g) The Secretary shall, upon request, provide to each 
individual released from service obligation under this section 
technical assistance to assist such individual in fulfilling 
his or her agreement under this section.

       breach of scholarship contract or loan repayment contract

    Sec. 338E. [254o] (a)(1) An individual who has entered into 
a written contract with the Secretary under section 338A and 
who--
            (A) fails to maintain an acceptable level of 
        academic standing in the educational institution in 
        which he is enrolled (such level determined by the 
        educational institution under regulations of the 
        Secretary);
            (B) is dismissed from such educational institution 
        for disciplinary reasons; or
            (C) voluntarily terminates the training in such an 
        educational institution for which he is provided a 
        scholarship under such contract, before the completion 
        of such training,
in lieu of any service obligation arising under such contract, 
shall be liable to the United States for the amount which has 
been paid to him, or on his behalf, under the contract.
    (2) An individual who has entered into a written contract 
with the Secretary under section 338B and who--
            (A) in the case of an individual who is enrolled in 
        the final year of a course of study, fails to maintain 
        an acceptable level of academic standing in the 
        educational institution in which such individual is 
        enrolled (such level determined by the educational 
        institution under regulations of the Secretary) or 
        voluntarily terminates such enrollment or is dismissed 
        from such educational institution before completion of 
        such course of study; or
            (B) in the case of an individual who is enrolled in 
        a graduate training program, fails to complete such 
        training program and does not receive a waiver from the 
        Secretary under section 338B(b)(1)(B)(ii),
in lieu of any service obligation arising under such contract 
shall be liable to the United States for the amount that has 
been paid on behalf of the individual under the contract.
    (b)(1)(A) Except as provided in paragraph (2), if (for any 
reason not specified in subsection (a) or section 338G(d)) an 
individual breaches his written contract by failing to begin 
such individual's service obligation under section 338A in 
accordance with section 338C or 338D, to complete such service 
obligation, or to complete a required residency as specified in 
section 338A(f)(1)(B)(iv), the United States shall be entitled 
to recover from the individual an amount determined in 
accordance with the formula

                              A=3q(t-s/t)

in which ``A'' is the amount the United States is entitled to 
recover, ``q'' is the sum of the amounts paid under this 
subpart to or on behalf of the individual and the interest on 
such amounts which would be payable if at the time the amounts 
were paid they were loans bearing interest at the maximum legal 
prevailing rate, as determined by the Treasurer of the United 
States; ``t'' is the total number of months in the individual's 
period of obligated service; and ``s'' is the number of months 
of such period served by him in accordance with section 338C or 
a written agreement under section 338D.
    (B)(i) Any amount of damages that the United States is 
entitled to recover under this subsection or under subsection 
(c) shall, within the 1-year period beginning on the date of 
the breach of the written contract (or such longer period 
beginning on such date as specified by the Secretary), be paid 
to the United States. Amounts not paid within such period shall 
be subject to collection through deductions in Medicare 
payments pursuant to section 1892 of the Social Security Act.
    (ii) If damages described in clause (i) are delinquent for 
3 months, the Secretary shall, for the purpose of recovering 
such damages--
            (I) utilize collection agencies contracted with by 
        the Administrator of the General Services 
        Administration; or
            (II) enter into contracts for the recovery of such 
        damages with collection agencies selected by the 
        Secretary.
    (iii) Each contract for recovering damages pursuant to this 
subsection shall provide that the contractor will, not less 
than once each 6 months, submit to the Secretary a status 
report on the success of the contractor in collecting such 
damages. Section 3718 of title 31, United States Code, shall 
apply to any such contract to the extent not inconsistent with 
this subsection.
    (iv) To the extent not otherwise prohibited by law, the 
Secretary shall disclose to all appropriate credit reporting 
agencies information relating to damages of more than $100 that 
are entitled to be recovered by the United States under this 
subsection and that are delinquent by more than 60 days or such 
longer period as is determined by the Secretary.
    (2) If an individual is released under section 753 from a 
service obligation under section 225 (as in effect on September 
30, 1977) and if the individual does not meet the service 
obligation incurred under section 753, subsection (f) of such 
section 225 shall apply to such individual in lieu of paragraph 
(1) of this subsection.
    (3) The Secretary may terminate a contract with an 
individual under section 338A if, not later than 30 days before 
the end of the school year to which the contract pertains, the 
individual--
            (A) submits a written request for such termination; 
        and
            (B) repays all amounts paid to, or on behalf of, 
        the individual under section 338A(g).
    (c)(1) If (for any reason not specified in subsection (a) 
or section 338G(d)) an individual breaches the written contract 
of the individual under section 338B by failing either to begin 
such individual's service obligation in accordance with section 
338C or 338D or to complete such service obligation, the United 
States shall be entitled to recover from the individual an 
amount equal to the sum of--
            (A) the total of the amounts paid by the United 
        States under section 338B(g) on behalf of the 
        individual for any period of obligated service not 
        served;
            (B) an amount equal to the product of the number of 
        months of obligated service that were not completed by 
        the individual, multiplied by $7,500; and
            (C) the interest on the amounts described in 
        subparagraphs (A) and (B), at the maximum legal 
        prevailing rate, as determined by the Treasurer of the 
        United States, from the date of the breach;
except that the amount the United States is entitled to recover 
under this paragraph shall not be less than $31,000.
    (2) The Secretary may terminate a contract with an 
individual under section 338B if, not later than 45 days before 
the end of the fiscal year in which the contract was entered 
into, the individual--
            (A) submits a written request for such termination; 
        and
            (B) repays all amounts paid on behalf of the 
        individual under section 338B(g).
    (3) Damages that the United States is entitled to recover 
shall be paid in accordance with subsection (b)(1)(B).
    (d)(1) Any obligation of an individual under the 
Scholarship Program (or a contract thereunder) or the Loan 
Repayment Program (or a contract thereunder) for service or 
payment of damages shall be canceled upon the death of the 
individual.
    (2) The Secretary shall by regulation provide for the 
partial or total waiver or suspension of any obligation of 
service or payment by an individual under the Scholarship 
Program (or a contract thereunder) or the Loan Repayment 
Program (or a contract thereunder) whenever compliance by the 
individual is impossible or would involve extreme hardship to 
the individual and if enforcement of such obligation with 
respect to any individual would be unconscionable.
    (3)(A) Any obligation of an individual under the 
Scholarship Program (or a contract thereunder) or the Loan 
Repayment Program (or a contract thereunder) for payment of 
damages may be released by a discharge in bankruptcy under 
title 11 of the United States Code only if such discharge is 
granted after the expiration of the 7-year period beginning on 
the first date that payment of such damages is required, and 
only if the bankruptcy court finds that nondischarge of the 
obligation would be unconscionable.
    (B)(i) Subparagraph (A) shall apply to any financial 
obligation of an individual under the provision of law 
specified in clause (ii) to the same extent and in the same 
manner as such subparagraph applies to any obligation of an 
individual under the Scholarship or Loan Repayment Program (or 
contract thereunder) for payment of damages.
    (ii) The provision of law referred to in clause (i) is 
subsection (f) of section 225 of this Act, as in effect prior 
to the repeal of such section by section 408(b)(1) of Public 
Law 94-484.
    (e) Notwithstanding any other provision of Federal or State 
law, there shall be no limitation on the period within which 
suit may be filed, a judgment may be enforced, or an action 
relating to an offset or garnishment, or other action, may be 
initiated or taken by the Secretary, the Attorney General, or 
the head of another Federal agency, as the case may be, for the 
repayment of the amount due from an individual under this 
section.
    (f) The amendment made by section 313(a)(4) of the Health 
Care Safety Net Amendments of 2002 (Public Law 107-251) shall 
apply to any obligation for which a discharge in bankruptcy has 
not been granted before the date that is 31 days after the date 
of enactment of such Act.

SEC. 338F. [254O-1] FUND REGARDING USE OF AMOUNTS RECOVERED FOR 
                    CONTRACT BREACH TO REPLACE SERVICES LOST AS RESULT 
                    OF BREACH.

    (a) Establishment of Fund.--There is established in the 
Treasury of the United States a fund to be known as the 
National Health Service Corps Member Replacement Fund 
(hereafter in this section referred to as the ``Fund''). The 
Fund shall consist of such amounts as may be appropriated under 
subsection (b) to the Fund. Amounts appropriated for the Fund 
shall remain available until expended.
    (b) Authorization of Appropriations to Fund.--For each 
fiscal year, there is authorized to be appropriated to the Fund 
an amount equal to the sum of--
            (1) the amount collected during the preceding 
        fiscal year by the Federal Government pursuant to the 
        liability of individuals under section 338E for the 
        breach of contracts entered into under section 338A or 
        338B;
            (2) the amount by which grants under section 338I 
        have, for such preceding fiscal year, been reduced 
        under subsection (g)(2)(B) of such section; and
            (3) the aggregate of the amount of interest 
        accruing during the preceding fiscal year on 
        obligations held in the Fund pursuant to subsection (d) 
        and the amount of proceeds from the sale or redemption 
        of such obligations during such fiscal year.
    (c) Use of Fund.--
            (1) Payments to certain health facilities.--Amounts 
        in the Fund and available pursuant to appropriations 
        Act may, subject to paragraph (2), be expended by the 
        Secretary to make payments to any entity--
                    (A) to which a Corps member has been 
                assigned under section 333; and
                    (B) that has a need for a health 
                professional to provide primary health services 
                as a result of the Corps member having breached 
                the contract entered into under section 338A or 
                338B by the individual.
            (2) Purpose of payments.--An entity receiving 
        payments pursuant to paragraph (1) may expend the 
        payments to recruit and employ a health professional to 
        provide primary health services to patients of the 
        entity, or to enter into a contract with such a 
        professional to provide the services to the patients.
    (d) Investment.--
            (1) In general.--The Secretary of the Treasury 
        shall invest such amounts of the Fund as such Secretary 
        determines are not required to meet current withdrawals 
        from the Fund. Such investments may be made only in 
        interest-bearing obligations of the United States. For 
        such purpose, such obligations may be acquired on 
        original issue at the issue price, or by purchase of 
        outstanding obligations at the market price.
            (2) Sale of obligations.--Any obligation acquired 
        by the Fund may be sold by the Secretary of the 
        Treasury at the market price.

    special loans for former corps members to enter private practice

    Sec. 338G. [254p] (a) The Secretary may, out of 
appropriations authorized under section 338, make one loan to a 
Corps member who has agreed in writing--
            (1) to engage in the private full-time clinical 
        practice of the profession of the member in a health 
        professional shortage area (designated under section 
        332) for a period of not less than 2 years which--
                    (A) in the case of a Corps member who is 
                required to complete a period of obligated 
                service under this subpart, begins not later 
                than 1 year after the date on which such 
                individual completes such period of obligated 
                service; and
                    (B) in the case of an individual who is not 
                required to complete a period of obligated 
                service under this subpart, begins at such time 
                as the Secretary considers appropriate;
            (2) to conduct such practice in accordance with 
        section 338D(b)(1); and
            (3) to such additional conditions as the Secretary 
        may require to carry out this section.
Such a loan shall be used to assist such individual in meeting 
the costs of beginning the practice of such individual's 
profession in accordance with such agreement, including the 
costs of acquiring equipment and renovating facilities for use 
in providing health services, and of hiring nurses and other 
personnel to assist in providing health services. Such loan may 
not be used for the purchase or construction of any building.
    (b)(1) The amount of a loan under subsection (a) to an 
individual shall not exceed $25,000.
    (2) The interest rate for any such loan shall not exceed an 
annual rate of 5 percent.
    (c) The Secretary may not make a loan under this section 
unless an application therefor has been submitted to, and 
approved by, the Secretary. The Secretary shall, by regulation, 
set interest rates and repayment terms for loans under this 
section.
    (d) If the Secretary determines that an individual has 
breached a written agreement entered into under subsection (a), 
he shall, as soon as practicable after making such 
determination notify the individual of such determination. If 
within 60 days after the date of giving such notice, such 
individual is not practicing his profession in accordance with 
the agreement under such subsection and has not provided 
assurances satisfactory to the Secretary that he will not 
knowingly violate such agreement again, the United States shall 
be entitled to recover from such individual--
            (1) in the case of an individual who has received a 
        grant under this section (as in effect prior to October 
        1, 1984), an amount determined under section 338E(b), 
        except that in applying the formula contained in such 
        section ``q'' shall be the sum of the amount of the 
        grant made under subsection (a) to such individual and 
        the interest on such amount which would be payable if 
        at the time it was paid it was a loan bearing interest 
        at the maximum legal prevailing rate, ``t'' shall be 
        the number of months that such individual agreed to 
        practice his profession under agreement, and ``s'' 
        shall be the number of months that such individual 
        practices his profession in accordance with such 
        agreement; and
            (2) in the case of an individual who has received a 
        loan under this section, the full amount of the 
        principal and interest owed by such individual under 
        this section.

SEC. 338H. [254Q] AUTHORIZATION OF APPROPRIATIONS.

    (a) Authorization of Appropriations.--For the purpose of 
carrying out this section \1\, there is authorized to be 
appropriated, out of any funds in the Treasury not otherwise 
appropriated, the following:
---------------------------------------------------------------------------
    \1\ The reference to ``this section'' in section 338H(a) probably 
should be a reference to ``this subpart''.
---------------------------------------------------------------------------
            (1) For fiscal year 2010, $320,461,632.
            (2) For fiscal year 2011, $414,095,394.
            (3) For fiscal year 2012, $535,087,442.
            (4) For fiscal year 2013, $691,431,432.
            (5) For fiscal year 2014, $893,456,433.
            (6) For fiscal year 2015, $1,154,510,336.
            (7) For fiscal year 2016, and each subsequent 
        fiscal year, the amount appropriated for the preceding 
        fiscal year adjusted by the product of--
                    (A) one plus the average percentage 
                increase in the costs of health professions 
                education during the prior fiscal year; and
                    (B) one plus the average percentage change 
                in the number of individuals residing in health 
                professions shortage areas designated under 
                section 333 during the prior fiscal year, 
                relative to the number of individuals residing 
                in such areas during the previous fiscal year.
    (b) Scholarships for New Participants.--Of the amounts 
appropriated under subsection (a) for a fiscal year, the 
Secretary shall obligate not less than 10 percent for the 
purpose of providing contracts for--
            (1) scholarships under this subpart to individuals 
        who have not previously received such scholarships; or
            (2) scholarships or loan repayments under the Loan 
        Repayment Program under section 338B to individuals 
        from disadvantaged backgrounds.
    (c) Scholarships and Loan Repayments.--With respect to 
certification as a nurse practitioner, nurse midwife, or 
physician assistant, the Secretary shall, from amounts 
appropriated under subsection (a) for a fiscal year, obligate 
not less than a total of 10 percent for contracts for both 
scholarships under the Scholarship Program under section 338A 
and loan repayments under the Loan Repayment Program under 
section 338B to individuals who are entering the first year of 
a course of study or program described in section 338A(b)(1)(B) 
that leads to such a certification or individuals who are 
eligible for the loan repayment program as specified in section 
338B(b) for a loan related to such certification.

SEC. 338I. [254Q-1] GRANTS TO STATES FOR LOAN REPAYMENT PROGRAMS.

    (a) In General.--
            (1) Authority for grants.--The Secretary, acting 
        through the Administrator of the Health Resources and 
        Services Administration, may make grants to States for 
        the purpose of assisting the States in operating 
        programs described in paragraph (2) in order to provide 
        for the increased availability of primary health care 
        services in health professional shortage areas. The 
        National Advisory Council established under section 337 
        shall advise the Administrator regarding the program 
        under this section.
            (2) Loan repayment programs.--The programs referred 
        to in paragraph (1) are, subject to subsection (c), 
        programs of entering into contracts under which the 
        State involved agrees to pay all or part of the 
        principal, interest, and related expenses of the 
        educational loans of health professionals in 
        consideration of the professionals agreeing to provide 
        primary health services in health professional shortage 
        areas.
            (3) Direct administration by state agency.--The 
        Secretary may not make a grant under paragraph (1) 
        unless the State involved agrees that the program 
        operated with the grant will be administered directly 
        by a State agency.
    (b) Requirement of Matching Funds.--
            (1) In general.--The Secretary may not make a grant 
        under subsection (a) unless the State agrees that, with 
        respect to the costs of making payments on behalf of 
        individuals under contracts made pursuant to paragraph 
        (2) of such subsection, the State will make available 
        (directly or through donations from public or private 
        entities) non-Federal contributions in cash toward such 
        costs in an amount equal to not less than $1 for each 
        $1 of Federal funds provided in the grant.
            (2) Determination of amount of non-federal 
        contribution.--In determining the amount of non-Federal 
        contributions in cash that a State has provided 
        pursuant to paragraph (1), the Secretary may not 
        include any amounts provided to the State by the 
        Federal Government.
    (c) Coordination With Federal Program.--
            (1) Assignments for health professional shortage 
        areas under federal program.--The Secretary may not 
        make a grant under subsection (a) unless the State 
        involved agrees that, in carrying out the program 
        operated with the grant, the State will assign health 
        professionals participating in the program only to 
        public and nonprofit private entities located in and 
        providing health services in health professional 
        shortage areas.
            (2) Remedies for breach of contracts.--The 
        Secretary may not make a grant under subsection (a) 
        unless the State involved agrees that the contracts 
        provided by the State pursuant to paragraph (2) of such 
        subsection will provide remedies for any breach of the 
        contracts by the health professionals involved.
            (3) Limitation regarding contract inducements.--
                    (A) Except as provided in subparagraph (B), 
                the Secretary may not make a grant under 
                subsection (a) unless the State involved agrees 
                that the contracts provided by the State 
                pursuant to paragraph (2) of such subsection 
                will not be provided on terms that are more 
                favorable to health professionals than the most 
                favorable terms that the Secretary is 
                authorized to provide for contracts under the 
                Loan Repayment Program under section 338B, 
                including terms regarding--
                            (i) the annual amount of payments 
                        provided on behalf of the professionals 
                        regarding educational loans; and
                            (ii) the availability of remedies 
                        for any breach of the contracts by the 
                        health professionals involved.
                    (B) With respect to the limitation 
                established in subparagraph (A) regarding the 
                annual amount of payments that may be provided 
                to a health professional under a contract 
                provided by a State pursuant to subsection 
                (a)(2), such limitation shall not apply with 
                respect to a contract if--
                            (i) the excess of such annual 
                        payments above the maximum amount 
                        authorized in section 338B(g)(2)(A) for 
                        annual payments regarding contracts is 
                        paid solely from non-Federal 
                        contributions under subsection (b); and
                            (ii) the contract provides that the 
                        health professional involved will 
                        satisfy the requirement of obligated 
                        service under the contract solely 
                        through the provision of primary health 
                        services in a health professional 
                        shortage area that is receiving 
                        priority for purposes of section 
                        333A(a)(1) and that is authorized to 
                        receive assignments under section 333 
                        of individuals who are participating in 
                        the Scholarship Program under section 
                        338A.
    (d) Restrictions on Use of Funds.--The Secretary may not 
make a grant under subsection (a) unless the State involved 
agrees that the grant will not be expended--
            (1) to conduct activities for which Federal funds 
        are expended--
                    (A) within the State to provide technical 
                or other nonfinancial assistance under 
                subsection (f) of section 330;
                    (B) under a memorandum of agreement entered 
                into with the State under subsection (h) of 
                such section; or
                    (C) under a grant under section 338J; or
            (2) for any purpose other than making payments on 
        behalf of health professionals under contracts entered 
        into pursuant to subsection (a)(2).
    (e) Reports.--The Secretary may not make a grant under 
subsection (a) unless the State involved agrees--
            (1) to submit to the Secretary such reports 
        regarding the States loan repayment program, as are 
        determined to be appropriate by the Secretary; and
            (2) to submit such a report not later than January 
        10 of each fiscal year immediately following any fiscal 
        year for which the State has received such a grant.
    (f) Requirement of Application.--The Secretary may not make 
a grant under subsection (a) unless an application for the 
grant is submitted to the Secretary and the application is in 
such form, is made in such manner, and contains such 
agreements, assurances, and information as the Secretary 
determines to be necessary to carry out such subsection.
    (g) Noncompliance.--
            (1) In general.--The Secretary may not make 
        payments under subsection (a) to a State for any fiscal 
        year subsequent to the first fiscal year of such 
        payments unless the Secretary determines that, for the 
        immediately preceding fiscal year, the State has 
        complied with each of the agreements made by the State 
        under this section.
            (2) Reduction in grant relative to number of 
        breached contracts.--
                    (A) Before making a grant under subsection 
                (a) to a State for a fiscal year, the Secretary 
                shall determine the number of contracts 
                provided by the State under paragraph (2) of 
                such subsection with respect to which there has 
                been an initial breach by the health 
                professionals involved during the fiscal year 
                preceding the fiscal year for which the State 
                is applying to receive the grant.
                    (B) Subject to paragraph (3), in the case 
                of a State with 1 or more initial breaches for 
                purposes of subparagraph (A), the Secretary 
                shall reduce the amount of a grant under 
                subsection (a) to the State for the fiscal year 
                involved by an amount equal to the sum of the 
                expenditures of Federal funds made regarding 
                the contracts involved and an amount 
                representing interest on the amount of such 
                expenditures, determined with respect to each 
                contract on the basis of the maximum legal rate 
                prevailing for loans made during the time 
                amounts were paid under the contract, as 
                determined by the Treasurer of the United 
                States.
            (3) Waiver regarding reduction in grant.--The 
        Secretary may waive the requirement established in 
        paragraph (2)(B) with respect to the initial breach of 
        a contract if the Secretary determines that such breach 
        by the health professional involved was attributable 
        solely to the professional having a serious illness.
    (h) Definitions.--For purposes of this section, the term 
``State'' means each of the 50 States, the District of 
Columbia, the Commonwealth of Puerto Rico, the United States 
Virgin Islands, Guam, American Samoa, Palau, the Marshall 
Islands, and the Commonwealth of the Northern Mariana Islands.
    (i) Authorization of Appropriations.--
            (1) In general.--For the purpose of making grants 
        under subsection (a), there are authorized to be 
        appropriated $12,000,000 for fiscal year 2008, and such 
        sums as may be necessary for each of fiscal years 2009 
        through 2012.
            (2) Availability.--Amounts appropriated under 
        paragraph (1) shall remain available until expended.
    (j) Public Health Loan Repayment.--
            (1) In general.--The Secretary may award grants to 
        States for the purpose of assisting such States in 
        operating loan repayment programs under which such 
        States enter into contracts to repay all or part of the 
        eligible loans borrowed by, or on behalf of, 
        individuals who agree to serve in State, local, or 
        tribal health departments that serve health 
        professional shortage areas or other areas at risk of a 
        public health emergency, as designated by the 
        Secretary.
            (2) Loans eligible for repayment.--To be eligible 
        for repayment under this subsection, a loan shall be a 
        loan made, insured, or guaranteed by the Federal 
        Government that is borrowed by, or on behalf of, an 
        individual to pay the cost of attendance for a program 
        of education leading to a degree appropriate for 
        serving in a State, local, or tribal health department 
        as determined by the Secretary and the chief executive 
        officer of the State in which the grant is 
        administered, at an institution of higher education (as 
        defined in section 102 of the Higher Education Act of 
        1965), including principal, interest, and related 
        expenses on such loan.
            (3) Applicability of existing requirements.--With 
        respect to awards made under paragraph (1)--
                    (A) the requirements of subsections (b), 
                (f), and (g) shall apply to such awards; and
                    (B) the requirements of subsection (c) 
                shall apply to such awards except that with 
                respect to paragraph (1) of such subsection, 
                the State involved may assign an individual 
                only to public and nonprofit private entities 
                that serve health professional shortage areas 
                or areas at risk of a public health emergency, 
                as determined by the Secretary.
            (4) Authorization of appropriations.--There are 
        authorized to be appropriated to carry out this 
        subsection, such sums as may be necessary for each of 
        fiscal years 2007 through 2010.

SEC. 338J. [254R]  GRANTS TO STATES FOR OPERATION OF OFFICES OF RURAL 
                    HEALTH.

    (a) In general.--The Secretary, action through the Director 
of the Office of Rural Health Policy (established in section 
711 of the Social Security Act), may make grants to States for 
the purpose of improving health care in rural areas through the 
operation of State offices of rural health.
    (b) Requirement of Matching Funds.--
            (1) In general.--The Secretary may not make a grant 
        under subsection (a) unless the State involved agrees, 
        with respect to the costs to be incurred by the State 
        in carrying out the purpose described in such 
        subsection, to provide non-Federal contributions toward 
        such costs in an amount equal to--
                    (A) for the first fiscal year of payments 
                under the grant, not less than $1 for each $3 
                of Federal funds provided in the grant;
                    (B) for any second fiscal year of such 
                payments, not less than $1 for each $1 of 
                Federal funds provided in the grant; and
                    (C) for any third fiscal year of such 
                payments, not less than $3 for each $1 of 
                Federal funds provided in the grant.
            (2) Determination of amount of non-federal 
        contribution.--
                    (A) Subject to subparagraph (B), non-
                Federal contributions required in paragraph (1) 
                may be in cash or in kind, fairly evaluated, 
                including plant, equipment, or services. 
                Amounts provided by the Federal Government, or 
                services assisted or subsidized to any 
                significant extent by the Federal Government, 
                may not be included in determining the amount 
                of such non-Federal contributions.
                    (B) The Secretary may not make a grant 
                under subsection (a) unless the State involved 
                agrees that--
                            (i) for the first fiscal year of 
                        payments under the grant, 100 percent 
                        or less of the non-Federal 
                        contributions required in paragraph (1) 
                        will be provided in the form of in-kind 
                        contributions;
                            (ii) for any second fiscal year of 
                        such payments, not more than 50 percent 
                        of such non-Federal contributions will 
                        be provided in the form of in-kind 
                        contributions; and
                            (iii) for any third fiscal year of 
                        such payments, such non-Federal 
                        contributions will be provided solely 
                        in the form of cash.
    (c) Certain Required Activities.--The Secretary may not 
make a grant under subsection (a) unless the State involved 
agrees that activities carried out by an office operated 
pursuant to such subsection will include--
            (1) establishing and maintaining within the State a 
        clearinghouse for collecting and disseminating 
        information on--
                    (A) rural health care issues;
                    (B) research findings relating to rural 
                health care; and
                    (C) innovative approaches to the delivery 
                of health care in rural areas;
            (2) coordinating the activities carried out in the 
        State that relate to rural health care, including 
        providing coordination for the purpose of avoiding 
        redundancy in such activities; and
            (3) identifying Federal and State programs 
        regarding rural health, and providing technical 
        assistance to public and nonprofit private entities 
        regarding participation in such programs.
    (d) Requirement Regarding Annual Budget for Office.--The 
Secretary may not make a grant under subsection (a) unless the 
State involved agrees that, for any fiscal year for which the 
State receives such a grant, the office operated pursuant to 
subsection (a) will be provided with an annual budget of not 
less than $50,000.
    (e) Certain Uses of Funds.--
            (1) Restrictions.--The Secretary may not make a 
        grant under subsection (a) unless the State involved 
        agrees that--
                    (A) if research with respect to rural 
                health is conducted pursuant to the grant, not 
                more than 10 percent of the grant will be 
                expended for such research; and
                    (B) the grant will not be expended--
                            (i) to provide health care 
                        (including providing cash payments 
                        regarding such care);
                            (ii) to conduct activities for 
                        which Federal funds are expended--
                                    (I) within the State to 
                                provide technical and other 
                                nonfinancial assistance under 
                                subsection (f) of section 330 
                                \1\;
---------------------------------------------------------------------------
    \1\ Probably should be ``subsection (k)''. See the amendment made 
by section 2 of Public Law 104-299 (110 Stat. 3626).
---------------------------------------------------------------------------
                                    (II) under a memorandum of 
                                agreement entered into with the 
                                State under subsection (h) of 
                                such section; \2\ or
---------------------------------------------------------------------------
    \2\ Probably should be ``subsection (m)''. See the amendment 
referred to in footnote 1.
---------------------------------------------------------------------------
                                    (III) under a grant under 
                                section 338I;
                            (iii) to purchase medical 
                        equipment, to purchase ambulances, 
                        aircraft, or other vehicles, or to 
                        purchase major communications 
                        equipment;
                            (iv) to purchase or improve real 
                        property; or
                            (v) to carry out any activity 
                        regarding a certificate of need.
            (2) Authorities.--Activities for which a State may 
        expend a grant under subsection (a) include--
                    (A) paying the costs of establishing an 
                office of rural health for purposes of 
                subsection (a);
                    (B) subject to paragraph (1)(B)(ii)(III), 
                paying the costs of any activity carried out 
                with respect to recruiting and retaining health 
                professionals to serve in rural areas of the 
                State; and
                    (C) providing grants and contracts to 
                public and nonprofit private entities to carry 
                out activities authorized in this section.
    (f) Reports.--The Secretary may not make a grant under 
subsection (a) unless the State involved agrees--
            (1) to submit to the Secretary reports containing 
        such information as the Secretary may require regarding 
        activities carried out under this section by the State; 
        and
            (2) to submit such a report not later than January 
        10 of each fiscal year immediately following any fiscal 
        year for which the State has received such a grant.
    (g) Requirement of Application.--The Secretary may not make 
a grant under subsection (a) unless an application for the 
grant is submitted to the Secretary and the application is in 
such form, is made in such manner, and contains such 
agreements, assurances, and information as the Secretary 
determines to be necessary to carry out such subsection.
    (h) Noncompliance.--The Secretary may not make payments 
under subsection (a) to a State for any fiscal year subsequent 
to the first fiscal year of such payments unless the Secretary 
determines that, for the immediately preceding fiscal year, the 
State has complied with each of the agreements made by the 
State under this section.
    (i) Definitions.--For purposes of this section, the term 
``State'' means each of the several States.
    (j) Authorization of Appropriations.--
            (1) In general.--For the purpose of making grants 
        under subsection (a), there are authorized to be 
        appropriated $3,000,000 for fiscal year 1991, 
        $4,000,000 for fiscal year 1992, $3,000,000 for fiscal 
        year 1993, and such sums as may be necessary for each 
        of the fiscal years 1998 through 2002.
            (2) Availability.--Amounts appropriated under 
        paragraph (1) shall remain available until expended.
    (k) Termination of Program.--No grant may be made under 
this section after the aggregate amounts appropriated under 
subsection (j)(1) are equal to $36,000,000.

SEC. 338K. [254S] NATIVE HAWAIIAN HEALTH SCHOLARSHIPS.

    (a) Subject to the availability of funds appropriated under 
the authority of subsection (d), the Secretary shall provide 
scholarship assistance, pursuant to a contract with the Papa 
Ola Lokahi, to students who--
            (1) meet the requirements of section 338A(b), and
            (2) are Native Hawaiians.
    (b)(1) The scholarship assistance provided under subsection 
(a) shall be provided under the same terms and subject to the 
same conditions, regulations, and rules that apply to 
scholarship assistance provided under section 338A.
    (2) The Native Hawaiian Health Scholarship program shall 
not be administered by or through the Indian Health Service.
    (c) For purposes of this section, the term ``Native 
Hawaiian'' means any individual who is--
            (1) a citizen of the United States,
            (2) a resident of the State of Hawaii, and
            (3) a descendant of the aboriginal people, who 
        prior to 1778, occupied and exercised sovereignty in 
        the area that now constitutes the State of Hawaii, as 
        evidenced by--
                    (A) genealogical records,
                    (B) Kupuna (elders) or Kama'aina (long-term 
                community residents) verification, or
                    (C) birth records of the State of Hawaii.
    (d) There are authorized to be appropriated $1,800,000 for 
each of the fiscal years 1990, 1991, and 1992 for the purpose 
of funding the scholarship assistance provided under subsection 
(a).

SEC. 338L. [254T] DEMONSTRATION PROJECT.

    (a) Program Authorized.--The Secretary shall establish a 
demonstration project to provide for the participation of 
individuals who are chiropractic doctors or pharmacists in the 
Loan Repayment Program described in section 338B.
    (b) Procedure.--An individual that receives assistance 
under this section with regard to the program described in 
section 338B shall comply with all rules and requirements 
described in such section (other than subparagraphs (A) and (B) 
of section 338B(b)(1)) in order to receive assistance under 
this section.
    (c) Limitations.--
            (1) In general.--The demonstration project 
        described in this section shall provide for the 
        participation of individuals who shall provide services 
        in rural and urban areas.
            (2) Availability of other health professionals.--
        The Secretary may not assign an individual receiving 
        assistance under this section to provide obligated 
        service at a site unless--
                    (A) the Secretary has assigned a physician 
                (as defined in section 1861(r) of the Social 
                Security Act) or other health professional 
                licensed to prescribe drugs to provide 
                obligated service at such site under section 
                338C or 338D; and
                    (B) such physician or other health 
                professional will provide obligated service at 
                such site concurrently with the individual 
                receiving assistance under this section.
            (3) Rules of construction.--
                    (A) Supervision of individuals.--Nothing in 
                this section shall be construed to require or 
                imply that a physician or other health 
                professional licensed to prescribe drugs must 
                supervise an individual receiving assistance 
                under the demonstration project under this 
                section, with respect to such project.
                    (B) Licensure of health professionals.--
                Nothing in this section shall be construed to 
                supersede State law regarding licensure of 
                health professionals.
    (d) Designations.--The demonstration project described in 
this section, and any providers who are selected to participate 
in such project, shall not be considered by the Secretary in 
the designation of a health professional shortage area under 
section 332 during fiscal years 2002 through 2004.
    (e) Rule of Construction.--This section shall not be 
construed to require any State to participate in the project 
described in this section.
    (f) Report.--
            (1) In general.--The Secretary shall evaluate the 
        participation of individuals in the demonstration 
        projects under this section and prepare and submit a 
        report containing the information described in 
        paragraph (2) to--
                    (A) the Committee on Health, Education, 
                Labor, and Pensions of the Senate;
                    (B) the Subcommittee on Labor, Health and 
                Human Services, and Education of the Committee 
                on Appropriations of the Senate;
                    (C) the Committee on Energy and Commerce of 
                the House of Representatives; and
                    (D) the Subcommittee on Labor, Health and 
                Human Services, and Education of the Committee 
                on Appropriations of the House of 
                Representatives.
            (2) Content.--The report described in paragraph (1) 
        shall detail--
                    (A) the manner in which the demonstration 
                project described in this section has affected 
                access to primary care services, patient 
                satisfaction, quality of care, and health care 
                services provided for traditionally underserved 
                populations;
                    (B) how the participation of chiropractic 
                doctors and pharmacists in the Loan Repayment 
                Program might affect the designation of health 
                professional shortage areas; and
                    (C) whether adding chiropractic doctors and 
                pharmacists as permanent members of the 
                National Health Service Corps would be feasible 
                and would enhance the effectiveness of the 
                National Health Service Corps.
    (g) Authorization of Appropriations.--
            (1) in general.--There are authorized to be 
        appropriated to carry out this section, such sums as 
        may be necessary for fiscal years 2002 through 2004.
            (2) Fiscal year 2005.--If the Secretary determines 
        and certifies to Congress by not later than September 
        30, 2004, that the number of individuals participating 
        in the demonstration project established under this 
        section is insufficient for purposes of performing the 
        evaluation described in subsection (f)(1), the 
        authorization of appropriations under paragraph (1) 
        shall be extended to include fiscal year 2005.

SEC. 338M. [254U] PUBLIC HEALTH DEPARTMENTS.

    (a) In General.--To the extent that funds are appropriated 
under subsection (e), the Secretary shall establish a 
demonstration project to provide for the participation of 
individuals who are eligible for the Loan Repayment Program 
described in section 338B and who agree to complete their 
service obligation in a State health department that provides a 
significant amount of service to health professional shortage 
areas or areas at risk of a public health emergency, as 
determined by the Secretary, or in a local or tribal health 
department that serves a health professional shortage area or 
an area at risk of a public health emergency.
    (b) Procedure.--To be eligible to receive assistance under 
subsection (a), with respect to the program described in 
section 338B, an individual shall--
            (1) comply with all rules and requirements 
        described in such section (other than section 
        338B(f)(1)(B)(iv)); and
            (2) agree to serve for a time period equal to 2 
        years, or such longer period as the individual may 
        agree to, in a State, local, or tribal health 
        department, described in subsection (a).
    (c) Designations.--The demonstration project described in 
subsection (a), and any healthcare providers who are selected 
to participate in such project, shall not be considered by the 
Secretary in the designation of health professional shortage 
areas under section 332 during fiscal years 2007 through 2010.
    (d) Report.--Not later than 3 years after the date of 
enactment of this section, the Secretary shall submit a report 
to the relevant committees of Congress that evaluates the 
participation of individuals in the demonstration project under 
subsection (a), the impact of such participation on State, 
local, and tribal health departments, and the benefit and 
feasibility of permanently allowing such placements in the Loan 
Repayment Program.
    (e) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section, such sums as may 
be necessary for each of fiscal years 2007 through 2010.

                    Subpart IV--Home Health Services

                          home health services

    Sec. 339. [255] (a)(1) For the purpose of encouraging the 
establishment and initial operation of home health programs to 
provide home health services in areas in which such services 
are inadequate or not readily accessible, the Secretary may, in 
accordance with the provisions of this section, make grants to 
public and nonprofit private entities and loans to proprietary 
entities to meet the initial costs of establishing and 
operating such home health programs. Such grants and loans may 
include funds to provide training for paraprofessionals 
(including homemaker home health aides) to provide home health 
services.
    (2) In making grants and loans under this subsection, the 
Secretary shall--
            (A) consider the relative needs of the several 
        States for home health services;
            (B) give preference to areas in which a high 
        percentage of the population proposed to be served is 
        composed of individuals who are elderly, medically 
        indigent, or disabled; and
            (C) give special consideration to areas with 
        inadequate means of transportation to obtain necessary 
        health services.
    (3)(A) No loan may be made to a proprietary entity under 
this section unless the application of such entity for such 
loan contains assurances satisfactory to the Secretary that--
            (i) at the time the application is made the entity 
        is fiscally sound;
            (ii) the entity is unable to secure a loan for the 
        project for which the application is submitted from 
        non-Federal lenders at the rate of interest prevailing 
        in the area in which the entity is located; and
            (iii) during the period of the loan, such entity 
        will remain fiscally sound.
    (B) Loans under this section shall be made at an interest 
rate comparable to the rate of interest prevailing on the date 
the loan is made with respect to the marketable obligations of 
the United States of comparable maturities, adjusted to provide 
for administrative costs.
    (4) Applications for grants and loans under this subsection 
shall be in such form and contain such information as the 
Secretary shall prescribe.
    (5) There are authorized to be appropriated for grants and 
loans under this subsection $5,000,000 for each of the fiscal 
years ending on September 30, 1983, September 30, 1984, 
September 30, 1985, September 30, 1986, and September 30, 1987.
    (b)(1) The Secretary may make grants to and enter into 
contracts with public and private entities to assist them in 
developing appropriate training programs for paraprofessionals 
(including homemaker home health aides) to provide home health 
services.
    (2) Any program established with a grant or contract under 
this subsection to train homemaker home health aides shall--
            (A) extend for at least forty hours, and consist of 
        classroom instruction and at least twenty hours (in the 
        aggregate) of supervised clinical instruction directed 
        toward preparing students to deliver home health 
        services;
            (B) be carried out under appropriate professional 
        supervision and be designed to train students to 
        maintain or enhance the personal care of an individual 
        in his home in a manner which promotes the functional 
        independence of the individual; and
            (C) include training in--
                    (i) personal care services designed to 
                assist an individual in the activities of daily 
                living such as bathing, exercising, personal 
                grooming, and getting in and out of bed; and
                    (ii) household care services such as 
                maintaining a safe living environment, light 
                housekeeping, and assisting in providing good 
                nutrition (by the purchasing and preparation of 
                food).
    (3) In making grants and entering into contracts under this 
subsection, special consideration shall be given to entities 
which establish or will establish programs to provide training 
for persons fifty years of age and older who wish to become 
paraprofessionals (including homemaker home health aides) to 
provide home health services.
    (4) Applications for grants and contracts under this 
subsection shall be in such form and contain such information 
as the Secretary shall prescribe.
    (5) There are authorized to be appropriated for grants and 
contracts under this subsection $2,000,000 for each of the 
fiscal years ending September 30, 1983, September 30, 1984, 
September 30, 1985, September 30, 1986, and September 30, 1987.
    (c) The Secretary shall report to the Committee on Labor 
and Human Resources of the Senate and the Committee on Energy 
and Commerce of the House of Representatives on or before 
January 1, 1984, with respect to--
            (1) the impact of grants made and contracts entered 
        into under subsections (a) and (b) (as such subsections 
        were in effect prior to October 1, 1981);
            (2) the need to continue grants and loans under 
        subsections (a) and (b) (as such subsections are in 
        effect on the day after the date of enactment of the 
        Orphan Drug Act); and
            (3) the extent to which standards have been applied 
        to the training of personnel who provide home health 
        services.
    (d) For purposes of this section, the term ``home health 
services'' has the meaning prescribed for the term by section 
1861(m) of the Social Security Act.

             Subpart V--Healthy Communities Access Program

SEC. 340. [256] GRANTS TO STRENGTHEN THE EFFECTIVENESS, EFFICIENCY, AND 
                    COORDINATION OF SERVICES FOR THE UNINSURED AND 
                    UNDERINSURED.

    (a) In General.--The Secretary may award grants to eligible 
entities to assist in the development of integrated health care 
delivery systems to serve communities of individuals who are 
uninsured and individuals who are underinsured--
            (1) to improve the efficiency of, and coordination 
        among, the providers providing services through such 
        systems;
            (2) to assist communities in developing programs 
        targeted toward preventing and managing chronic 
        diseases; and
            (3) to expand and enhance the services provided 
        through such systems.
    (b) Eligible Entities.--To be eligible to receive a grant 
under this section, an entity shall be an entity that--
            (1) represents a consortium--
                    (A) whose principal purpose is to provide a 
                broad range of coordinated health care services 
                for a community defined in the entity's grant 
                application as described in paragraph (2); and
                    (B) that includes at least one of each of 
                the following providers that serve the 
                community (unless such provider does not exist 
                within the community, declines or refuses to 
                participate, or places unreasonable conditions 
                on their participation)--
                            (i) a Federally qualified health 
                        center (as defined in section 1861(aa) 
                        of the Social Security Act (42 U.S.C. 
                        1395x(aa)));
                            (ii) a hospital with a low-income 
                        utilization rate (as defined in section 
                        1923(b)(3) of the Social Security Act 
                        (42 U.S.C. 1396r-4(b)(3)), that is 
                        greater than 25 percent;
                            (iii) a public health department; 
                        and
                            (iv) an interested public or 
                        private sector health care provider or 
                        an organization that has traditionally 
                        served the medically uninsured and 
                        underserved; and
            (2) submits to the Secretary an application, in 
        such form and manner as the Secretary shall prescribe, 
        that--
                    (A) defines a community or geographic area 
                of uninsured and underinsured individuals;
                    (B) identifies the providers who will 
                participate in the consortium's program under 
                the grant, and specifies each provider's 
                contribution to the care of uninsured and 
                underinsured individuals in the community, 
                including the volume of care the provider 
                provides to beneficiaries under the medicare, 
                medicaid, and State child health insurance 
                programs and to patients who pay privately for 
                services;
                    (C) describes the activities that the 
                applicant and the consortium propose to perform 
                under the grant to further the objectives of 
                this section;
                    (D) demonstrates the consortium's ability 
                to build on the current system (as of the date 
                of submission of the application) for serving a 
                community or geographic area of uninsured and 
                underinsured individuals by involving providers 
                who have traditionally provided a significant 
                volume of care for that community;
                    (E) demonstrates the consortium's ability 
                to develop coordinated systems of care that 
                either directly provide or ensure the prompt 
                provision of a broad range of high-quality, 
                accessible services, including, as appropriate, 
                primary, secondary, and tertiary services, as 
                well as substance abuse treatment and mental 
                health services in a manner that assures 
                continuity of care in the community or 
                geographic area;
                    (F) provides evidence of community 
                involvement in the development, implementation, 
                and direction of the program that the entity 
                proposes to operate;
                    (G) demonstrates the consortium's ability 
                to ensure that individuals participating in the 
                program are enrolled in public insurance 
                programs for which the individuals are eligible 
                or know of private insurance programs where 
                available;
                    (H) presents a plan for leveraging other 
                sources of revenue, which may include State and 
                local sources and private grant funds, and 
                integrating current and proposed new funding 
                sources in a way to assure long-term 
                sustainability of the program;
                    (I) describes a plan for evaluation of the 
                activities carried out under the grant, 
                including measurement of progress toward the 
                goals and objectives of the program and the use 
                of evaluation findings to improve program 
                performance;
                    (J) demonstrates fiscal responsibility 
                through the use of appropriate accounting 
                procedures and appropriate management systems;
                    (K) demonstrates the consortium's 
                commitment to serve the community without 
                regard to the ability of an individual or 
                family to pay by arranging for or providing 
                free or reduced charge care for the poor; and
                    (L) includes such other information as the 
                Secretary may prescribe.
    (c) Limitations.--
            (1) Number of awards.--
                    (A) In general.--For each of fiscal years 
                2003, 2004, 2005, and 2006, the Secretary may 
                not make more than 35 new awards under 
                subsection (a) (excluding renewals of such 
                awards).
                    (B) Rule of construction.--This paragraph 
                shall not be construed to affect awards made 
                before fiscal year 2003.
            (2) In general.--An eligible entity may not receive 
        a grant under this section (including with respect to 
        any such grant made before fiscal year 2003) for more 
        than 3 consecutive fiscal years, except that such 
        entity may receive such a grant award for not more than 
        1 additional fiscal year if--
                    (A) the eligible entity submits to the 
                Secretary a request for a grant for such an 
                additional fiscal year;
                    (B) the Secretary determines that 
                extraordinary circumstances (as defined in 
                paragraph (3)) justify the granting of such 
                request; and
                    (C) the Secretary determines that granting 
                such request is necessary to further the 
                objectives described in subsection (a).
            (3) Extraordinary circumstances.--
                    (A) In general.--In paragraph (2), the term 
                ``extraordinary circumstances'' means an event 
                (or events) that is outside of the control of 
                the eligible entity that has prevented the 
                eligible entity from fulfilling the objectives 
                described by such entity in the application 
                submitted under subsection (b)(2).
                    (B) Examples.--Extraordinary circumstances 
                include--
                            (i) natural disasters or other 
                        major disruptions to the security or 
                        health of the community or geographic 
                        area served by the eligible entity; or
                            (ii) a significant economic 
                        deterioration in the community or 
                        geographic area served by such eligible 
                        entity, that directly and adversely 
                        affects the entity receiving an award 
                        under subsection (a).
    (d) Priorities.--In awarding grants under this section, the 
Secretary--
            (1) shall accord priority to applicants that 
        demonstrate the extent of unmet need in the community 
        involved for a more coordinated system of care; and
            (2) may accord priority to applicants that best 
        promote the objectives of this section, taking into 
        consideration the extent to which the application 
        involved--
                    (A) identifies a community whose 
                geographical area has a high or increasing 
                percentage of individuals who are uninsured;
                    (B) demonstrates that the applicant has 
                included in its consortium providers, support 
                systems, and programs that have a tradition of 
                serving uninsured individuals and underinsured 
                individuals in the community;
                    (C) shows evidence that the program would 
                expand utilization of preventive and primary 
                care services for uninsured and underinsured 
                individuals and families in the community, 
                including behavioral and mental health 
                services, oral health services, or substance 
                abuse services;
                    (D) proposes a program that would improve 
                coordination between health care providers and 
                appropriate social service providers;
                    (E) demonstrates collaboration with State 
                and local governments;
                    (F) demonstrates that the applicant makes 
                use of non-Federal contributions to the 
                greatest extent possible; or
                    (G) demonstrates a likelihood that the 
                proposed program will continue after support 
                under this section ceases.
    (e) Use of Funds.--
            (1) Use by grantees.--
                    (A) In general.--Except as provided in 
                paragraphs (2) and (3), a grantee may use 
                amounts provided under this section only for--
                            (i) direct expenses associated with 
                        achieving the greater integration of a 
                        health care delivery system so that the 
                        system either directly provides or 
                        ensures the provision of a broad range 
                        of culturally competent services, as 
                        appropriate, including primary, 
                        secondary, and tertiary services, as 
                        well as substance abuse treatment and 
                        mental health services; and
                            (ii) direct patient care and 
                        service expansions to fill identified 
                        or documented gaps within an integrated 
                        delivery system.
                    (B) Specific uses.--The following are 
                examples of purposes for which a grantee may 
                use grant funds under this section, when such 
                use meets the conditions stated in subparagraph 
                (A):
                            (i) Increases in outreach 
                        activities and closing gaps in health 
                        care service.
                            (ii) Improvements to case 
                        management.
                            (iii) Improvements to coordination 
                        of transportation to health care 
                        facilities.
                            (iv) Development of provider 
                        networks and other innovative models to 
                        engage physicians in voluntary efforts 
                        to serve the medically underserved 
                        within a community.
                            (v) Recruitment, training, and 
                        compensation of necessary personnel.
                            (vi) Acquisition of technology for 
                        the purpose of coordinating care.
                            (vii) Improvements to provider 
                        communication, including implementation 
                        of shared information systems or shared 
                        clinical systems.
                            (viii) Development of common 
                        processes for determining eligibility 
                        for the programs provided through the 
                        system, including creating common 
                        identification cards and single sliding 
                        scale discounts.
                            (ix) Development of specific 
                        prevention and disease management tools 
                        and processes.
                            (x) Translation services.
                            (xi) Carrying out other activities 
                        that may be appropriate to a community 
                        and that would increase access by the 
                        uninsured to health care, such as 
                        access initiatives for which private 
                        entities provide non-Federal 
                        contributions to supplement the Federal 
                        funds provided through the grants for 
                        the initiatives.
            (2) Direct patient care limitation.--Not more than 
        15 percent of the funds provided under a grant awarded 
        under this section may be used for providing direct 
        patient care and services.
            (3) Reservation of funds for national program 
        purposes.--The Secretary may use not more than 3 
        percent of funds appropriated to carry out this section 
        for providing technical assistance to grantees, 
        obtaining assistance of experts and consultants, 
        holding meetings, developing of tools, disseminating of 
        information, evaluation, and carrying out activities 
        that will extend the benefits of programs funded under 
        this section to communities other than the community 
        served by the program funded.
    (f) Grantee Requirements.--
            (1) Evaluation of effectiveness.--A grantee under 
        this section shall--
                    (A) report to the Secretary annually 
                regarding--
                            (i) progress in meeting the goals 
                        and measurable objectives set forth in 
                        the grant application submitted by the 
                        grantee under subsection (b); and
                            (ii) the extent to which activities 
                        conducted by such grantee have--
                                    (I) improved the 
                                effectiveness, efficiency, and 
                                coordination of services for 
                                uninsured and underinsured 
                                individuals in the communities 
                                or geographic areas served by 
                                such grantee;
                                    (II) resulted in the 
                                provision of better quality 
                                health care for such 
                                individuals; and
                                    (III) resulted in the 
                                provision of health care to 
                                such individuals at lower cost 
                                than would have been possible 
                                in the absence of the 
                                activities conducted by such 
                                grantee; and
                    (B) provide for an independent annual 
                financial audit of all records that relate to 
                the disposition of funds received through the 
                grant.
            (2) Progress.--The Secretary may not renew an 
        annual grant under this section for an entity for a 
        fiscal year unless the Secretary is satisfied that the 
        consortium represented by the entity has made 
        reasonable and demonstrable progress in meeting the 
        goals and measurable objectives set forth in the 
        entity's grant application for the preceding fiscal 
        year.
    (g) Maintenance of Effort.--With respect to activities for 
which a grant under this section is authorized, the Secretary 
may award such a grant only if the applicant for the grant, and 
each of the participating providers, agree that the grantee and 
each such provider will maintain its expenditures of non-
Federal funds for such activities at a level that is not less 
than the level of such expenditures during the fiscal year 
immediately preceding the fiscal year for which the applicant 
is applying to receive such grant.
    (h) Technical Assistance.--The Secretary may, either 
directly or by grant or contract, provide any entity that 
receives a grant under this section with technical and other 
nonfinancial assistance necessary to meet the requirements of 
this section.
    (i) Evaluation of Program.--Not later than September 30, 
2005, the Secretary shall prepare and submit to the appropriate 
committees of Congress a report that describes the extent to 
which projects funded under this section have been successful 
in improving the effectiveness, efficiency, and coordination of 
services for uninsured and underinsured individuals in the 
communities or geographic areas served by such projects, 
including whether the projects resulted in the provision of 
better quality health care for such individuals, and whether 
such care was provided at lower costs, than would have been 
provided in the absence of such projects.
    (j) Demonstration Authority.--The Secretary may make 
demonstration awards under this section to historically black 
health professions schools for the purposes of--
            (1) developing patient-based research 
        infrastructure at historically black health professions 
        schools, which have an affiliation, or affiliations, 
        with any of the providers identified in subsection 
        (b)(1)(B);
            (2) establishment of joint and collaborative 
        programs of medical research and data collection 
        between historically black health professions schools 
        and such providers, whose goal is to improve the health 
        status of medically underserved populations; or
            (3) supporting the research-related costs of 
        patient care, data collection, and academic training 
        resulting from such affiliations.
    (k) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section such sums as may 
be necessary for each of fiscal years 2002 through 2006.
    (l) Date Certain for Termination of Program.--Funds may not 
be appropriated to carry out this section after September 30, 
2006.

SEC. 340A. [256A] PATIENT NAVIGATOR GRANTS.

    (a) Grants.--The Secretary, acting through the 
Administrator of the Health Resources and Services 
Administration, may make grants to eligible entities for the 
development and operation of demonstration programs to provide 
patient navigator services to improve health care outcomes. The 
Secretary shall coordinate with, and ensure the participation 
of, the Indian Health Service, the National Cancer Institute, 
the Office of Rural Health Policy, and such other offices and 
agencies as deemed appropriate by the Secretary, regarding the 
design and evaluation of the demonstration programs.
    (b) Use of Funds.--The Secretary shall require each 
recipient of a grant under this section to use the grant to 
recruit, assign, train, and employ patient navigators who have 
direct knowledge of the communities they serve to facilitate 
the care of individuals, including by performing each of the 
following duties:
            (1) Acting as contacts, including by assisting in 
        the coordination of health care services and provider 
        referrals, for individuals who are seeking prevention 
        or early detection services for, or who following a 
        screening or early detection service are found to have 
        a symptom, abnormal finding, or diagnosis of, cancer or 
        other chronic disease.
            (2) Facilitating the involvement of community 
        organizations in assisting individuals who are at risk 
        for or who have cancer or other chronic diseases to 
        receive better access to high-quality health care 
        services (such as by creating partnerships with patient 
        advocacy groups, charities, health care centers, 
        community hospice centers, other health care providers, 
        or other organizations in the targeted community).
            (3) Notifying individuals of clinical trials and, 
        on request, facilitating enrollment of eligible 
        individuals in these trials.
            (4) Anticipating, identifying, and helping patients 
        to overcome barriers within the health care system to 
        ensure prompt diagnostic and treatment resolution of an 
        abnormal finding of cancer or other chronic disease.
            (5) Coordinating with the relevant health insurance 
        ombudsman programs to provide information to 
        individuals who are at risk for or who have cancer or 
        other chronic diseases about health coverage, including 
        private insurance, health care savings accounts, and 
        other publicly funded programs (such as Medicare, 
        Medicaid, health programs operated by the Department of 
        Veterans Affairs or the Department of Defense, the 
        State children's health insurance program, and any 
        private or governmental prescription assistance 
        programs).
            (6) Conducting ongoing outreach to health disparity 
        populations, including the uninsured, rural 
        populations, and other medically underserved 
        populations, in addition to assisting other individuals 
        who are at risk for or who have cancer or other chronic 
        diseases to seek preventative care.
    (c) Prohibitions.--
            (1) Referral fees.--The Secretary shall require 
        each recipient of a grant under this section to 
        prohibit any patient navigator providing services under 
        the grant from accepting any referral fee, kickback, or 
        other thing of value in return for referring an 
        individual to a particular health care provider.
            (2) Legal fees and costs.--The Secretary shall 
        prohibit the use of any grant funds received under this 
        section to pay any fees or costs resulting from any 
        litigation, arbitration, mediation, or other proceeding 
        to resolve a legal dispute.
    (d) Grant Period.--
            (1) In general.--Subject to paragraphs (2) and (3), 
        the Secretary may award grants under this section for 
        periods of not more than 3 years.
            (2) Extensions.--Subject to paragraph (3), the 
        Secretary may extend the period of a grant under this 
        section. Each such extension shall be for a period of 
        not more than 1 year.
            (3) Limitations on grant period.--In carrying out 
        this section, the Secretary shall ensure that the total 
        period of a grant does not exceed 4 years.
    (e) Application.--
            (1) In general.--To seek a grant under this 
        section, an eligible entity shall submit an application 
        to the Secretary in such form, in such manner, and 
        containing such information as the Secretary may 
        require.
            (2) Contents.--At a minimum, the Secretary shall 
        require each such application to outline how the 
        eligible entity will establish baseline measures and 
        benchmarks that meet the Secretary's requirements to 
        evaluate program outcomes.
            (3) Minimum core proficiencies.--The Secretary 
        shall not award a grant to an entity under this section 
        unless such entity provides assurances that patient 
        navigators recruited, assigned, trained, or employed 
        using grant funds meet minimum core proficiencies, as 
        defined by the entity that submits the application, 
        that are tailored for the main focus or intervention of 
        the navigator involved.
    (f) Uniform Baseline Measures.--The Secretary shall 
establish uniform baseline measures in order to properly 
evaluate the impact of the demonstration projects under this 
section.
    (g) Preference.--In making grants under this section, the 
Secretary shall give preference to eligible entities that 
demonstrate in their applications plans to utilize patient 
navigator services to overcome significant barriers in order to 
improve health care outcomes in their respective communities.
    (h) Duplication of Services.--An eligible entity that is 
receiving Federal funds for activities described in subsection 
(b) on the date on which the entity submits an application 
under subsection (e) may not receive a grant under this section 
unless the entity can demonstrate that amounts received under 
the grant will be utilized to expand services or provide new 
services to individuals who would not otherwise be served.
    (i) Coordination With Other Programs.--The Secretary shall 
ensure coordination of the demonstration grant program under 
this section with existing authorized programs in order to 
facilitate access to high-quality health care services.
    (j) Study; Reports.--
            (1) Final report by secretary.--Not later than 6 
        months after the completion of the demonstration grant 
        program under this section, the Secretary shall conduct 
        a study of the results of the program and submit to the 
        Congress a report on such results that includes the 
        following:
                    (A) An evaluation of the program outcomes, 
                including--
                            (i) quantitative analysis of 
                        baseline and benchmark measures; and
                            (ii) aggregate information about 
                        the patients served and program 
                        activities.
                    (B) Recommendations on whether patient 
                navigator programs could be used to improve 
                patient outcomes in other public health areas.
            (2) Interim reports by secretary.--The Secretary 
        may provide interim reports to the Congress on the 
        demonstration grant program under this section at such 
        intervals as the Secretary determines to be 
        appropriate.
            (3) Reports by grantees.--The Secretary may require 
        grant recipients under this section to submit interim 
        and final reports on grant program outcomes.
    (k) Rule of Construction.--This section shall not be 
construed to authorize funding for the delivery of health care 
services (other than the patient navigator duties listed in 
subsection (b)).
    (l) Definitions.--In this section:
            (1) The term ``eligible entity'' means a public or 
        nonprofit private health center (including a Federally 
        qualified health center (as that term is defined in 
        section 1861(aa)(4) of the Social Security Act)), a 
        health facility operated by or pursuant to a contract 
        with the Indian Health Service, a hospital, a cancer 
        center, a rural health clinic, an academic health 
        center, or a nonprofit entity that enters into a 
        partnership or coordinates referrals with such a 
        center, clinic, facility, or hospital to provide 
        patient navigator services.
            (2) The term ``health disparity population'' means 
        a population that, as determined by the Secretary, has 
        a significant disparity in the overall rate of disease 
        incidence, prevalence, morbidity, mortality, or 
        survival rates as compared to the health status of the 
        general population.
            (3) The term ``patient navigator'' means an 
        individual who has completed a training program 
        approved by the Secretary to perform the duties listed 
        in subsection (b).
    (m) Authorization of Appropriations.--
            (1) In general.--To carry out this section, there 
        are authorized to be appropriated $2,000,000 for fiscal 
        year 2006, $5,000,000 for fiscal year 2007, $8,000,000 
        for fiscal year 2008, $6,500,000 for fiscal year 2009, 
        $3,500,000 for fiscal year 2010, and such sums as may 
        be necessary for each of fiscal years 2011 through 
        2015.
            (2) Availability.--The amounts appropriated 
        pursuant to paragraph (1) shall remain available for 
        obligation through the end of fiscal year 2015.

                Subpart VII--Drug Pricing Agreements \1\
---------------------------------------------------------------------------

    \1\ So in law. Former subpart VI was repealed by section 4(a)(3) of 
Public Law 104-299 (110 Stat. 3645).
---------------------------------------------------------------------------
      limitation on prices of drugs purchased by covered entities
    Sec. 340B. [256b] (a) Requirements for Agreement With 
Secretary.--
            (1) In general.--The Secretary shall enter into an 
        agreement with each manufacturer of covered outpatient 
        drugs under which the amount required to be paid 
        (taking into account any rebate or discount, as 
        provided by the Secretary) to the manufacturer for 
        covered outpatient drugs (other than drugs described in 
        paragraph (3)) purchased by a covered entity on or 
        after the first day of the first month that begins 
        after the date of the enactment of this section, does 
        not exceed an amount equal to the average manufacturer 
        price for the drug under title XIX of the Social 
        Security Act in the preceding calendar quarter, reduced 
        by the rebate percentage described in paragraph (2). 
        Each such agreement shall require that the manufacturer 
        furnish the Secretary with reports, on a quarterly 
        basis, of the price for each covered outpatient drug 
        subject to the agreement that, according to the 
        manufacturer, represents the maximum price that covered 
        entities may permissibly be required to pay for the 
        drug (referred to in this section as the ``ceiling 
        price''), and shall require that the manufacturer offer 
        each covered entity covered outpatient drugs for 
        purchase at or below the applicable ceiling price if 
        such drug is made available to any other purchaser at 
        any price.
            (2) Rebate percentage defined.--
                    (A) In general.--For a covered outpatient 
                drug purchased in a calendar quarter, the 
                ``rebate percentage'' is the amount (expressed 
                as a percentage) equal to--
                            (i) the average total rebate 
                        required under section 1927(c) of the 
                        Social Security Act with respect to the 
                        drug (for a unit of the dosage form and 
                        strength involved) during the preceding 
                        calendar quarter; divided by
                            (ii) the average manufacturer price 
                        for such a unit of the drug during such 
                        quarter.
                    (B) Over the counter drugs.--
                            (i) In general.--For purposes of 
                        subparagraph (A), in the case of over 
                        the counter drugs, the ``rebate 
                        percentage'' shall be determined as if 
                        the rebate required under section 
                        1927(c) of the Social Security Act is 
                        based on the applicable percentage 
                        provided under section 1927(c)(3) of 
                        such Act.
                            (ii) Definition.--The term ``over 
                        the counter drug'' means a drug that 
                        may be sold without a prescription and 
                        which is prescribed by a physician (or 
                        other persons authorized to prescribe 
                        such drug under State law).
            (3) Drugs provided under state medicaid plans.--
        Drugs described in this paragraph are drugs purchased 
        by the entity for which payment is made by the State 
        under the State plan for medical assistance under title 
        XIX of the Social Security Act.
            (4) Covered entity defined.--In this section, the 
        term ``covered entity'' means an entity that meets the 
        requirements described in paragraph (5) and is one of 
        the following:
                    (A) A Federally-qualified health center (as 
                defined in section 1905(l)(2)(B) of the Social 
                Security Act).
                    (B) An entity receiving a grant under 
                section 340A \1\.
---------------------------------------------------------------------------
    \1\ See footnote on preceding page. See also footnote for section 
217(a).
---------------------------------------------------------------------------
                    (C) A family planning project receiving a 
                grant or contract under section 1001.
                    (D) An entity receiving a grant under 
                subpart II of part C of title XXVI (relating to 
                categorical grants for outpatient early 
                intervention services for HIV disease).
                    (E) A State-operated AIDS drug purchasing 
                assistance program receiving financial 
                assistance under title XXVI.
                    (F) A black lung clinic receiving funds 
                under section 427(a) of the Black Lung Benefits 
                Act.
                    (G) A comprehensive hemophilia diagnostic 
                treatment center receiving a grant under 
                section 501(a)(2) of the Social Security Act.
                    (H) A Native Hawaiian Health Center 
                receiving funds under the Native Hawaiian 
                Health Care Act of 1988.
                    (I) An urban Indian organization receiving 
                funds under title V of the Indian Health Care 
                Improvement Act.
                    (J) Any entity receiving assistance under 
                title XXVI (other than a State or unit of local 
                government or an entity described in 
                subparagraph (D)), but only if the entity is 
                certified by the Secretary pursuant to 
                paragraph (7).
                    (K) An entity receiving funds under section 
                318 (relating to treatment of sexually 
                transmitted diseases) or section 317(j)(2) 
                (relating to treatment of tuberculosis) through 
                a State or unit of local government, but only 
                if the entity is certified by the Secretary 
                pursuant to paragraph (7).
                    (L) A subsection (d) hospital (as defined 
                in section 1886(d)(1)(B) of the Social Security 
                Act) that--
                            (i) is owned or operated by a unit 
                        of State or local government, is a 
                        public or private non-profit 
                        corporation which is formally granted 
                        governmental powers by a unit of State 
                        or local government, or is a private 
                        non-profit hospital which has a 
                        contract with a State or local 
                        government to provide health care 
                        services to low income individuals who 
                        are not entitled to benefits under 
                        title XVIII of the Social Security Act 
                        or eligible for assistance under the 
                        State plan under this title;
                            (ii) for the most recent cost 
                        reporting period that ended before the 
                        calendar quarter involved, had a 
                        disproportionate share adjustment 
                        percentage (as determined under section 
                        1886(d)(5)(F) of the Social Security 
                        Act) greater than 11.75 percent or was 
                        described in section 
                        1886(d)(5)(F)(i)(II) of such Act; and
                            (iii) does not obtain covered 
                        outpatient drugs through a group 
                        purchasing organization or other group 
                        purchasing arrangement.
                    (M) A children's hospital excluded from the 
                Medicare prospective payment system pursuant to 
                section 1886(d)(1)(B)(iii) of the Social 
                Security Act, or a free-standing cancer 
                hospital excluded from the Medicare prospective 
                payment system pursuant to section 
                1886(d)(1)(B)(v) of the Social Security Act, 
                that would meet the requirements of 
                subparagraph (L), including the 
                disproportionate share adjustment percentage 
                requirement under clause (ii) of such 
                subparagraph, if the hospital were a subsection 
                (d) hospital as defined by section 
                1886(d)(1)(B) of the Social Security Act.
                    (N) An entity that is a critical access 
                hospital (as determined under section 
                1820(c)(2) of the Social Security Act), and 
                that meets the requirements of subparagraph 
                (L)(i).
                    (O) An entity that is a rural referral 
                center, as defined by section 1886(d)(5)(C)(i) 
                of the Social Security Act, or a sole community 
                hospital, as defined by section 
                1886(d)(5)(C)(iii) of such Act, and that both 
                meets the requirements of subparagraph (L)(i) 
                and has a disproportionate share adjustment 
                percentage equal to or greater than 8 percent.
            (5) Requirements for covered entities.--
                    (A) Prohibiting duplicate discounts or 
                rebates.--
                            (i) In general.--A covered entity 
                        shall not request payment under title 
                        XIX of the Social Security Act for 
                        medical assistance described in section 
                        1905(a)(12) of such Act with respect to 
                        a drug that is subject to an agreement 
                        under this section if the drug is 
                        subject to the payment of a rebate to 
                        the State under section 1927 of such 
                        Act.
                            (ii) Establishment of mechanism.--
                        The Secretary shall establish a 
                        mechanism to ensure that covered 
                        entities comply with clause (i). If the 
                        Secretary does not establish a 
                        mechanism within 12 months under the 
                        previous sentence, the requirements of 
                        section 1927(a)(5)(C) of the Social 
                        Security Act shall apply.
                    (B) Prohibiting resale of drugs.--With 
                respect to any covered outpatient drug that is 
                subject to an agreement under this subsection, 
                a covered entity shall not resell or otherwise 
                transfer the drug to a person who is not a 
                patient of the entity.
                    (C) Auditing.--A covered entity shall 
                permit the Secretary and the manufacturer of a 
                covered outpatient drug that is subject to an 
                agreement under this subsection with the entity 
                (acting in accordance with procedures 
                established by the Secretary relating to the 
                number, duration, and scope of audits) to audit 
                at the Secretary's or the manufacturer's 
                expense the records of the entity that directly 
                pertain to the entity's compliance with the 
                requirements described in subparagraphs (A) or 
                (B) with respect to drugs of the manufacturer.
                    (D) Additional sanction for 
                noncompliance.--If the Secretary finds, after 
                audit as described in subparagraph (C) and 
                after notice and hearing, that a covered entity 
                is in violation of a requirement described in 
                subparagraphs \1\ (A) or (B), the covered 
                entity shall be liable to the manufacturer of 
                the covered outpatient drug that is the subject 
                of the violation in an amount equal to the 
                reduction in the price of the drug (as 
                described in subparagraph (A)) provided under 
                the agreement between the entity and the 
                manufacturer under this paragraph.
---------------------------------------------------------------------------
    \1\ So in law. See section 602(a) of Public Law 102-585 (106 Stat. 
4967). Probably should be ``subparagraph''.
---------------------------------------------------------------------------
            (6) Treatment of distinct units of hospitals.--In 
        the case of a covered entity that is a distinct part of 
        a hospital, the hospital shall not be considered a 
        covered entity under this paragraph unless the hospital 
        is otherwise a covered entity under this subsection.
            (7) Certification of certain covered entities.--
                    (A) Development of process.--Not later than 
                60 days after the date of enactment of this 
                subsection, the Secretary shall develop and 
                implement a process for the certification of 
                entities described in subparagraphs (J) and (K) 
                of paragraph (4).
                    (B) Inclusion of purchase information.--The 
                process developed under subparagraph (A) shall 
                include a requirement that an entity applying 
                for certification under this paragraph submit 
                information to the Secretary concerning the 
                amount such entity expended for covered 
                outpatient drugs in the preceding year so as to 
                assist the Secretary in evaluating the validity 
                of the entity's subsequent purchases of covered 
                outpatient drugs at discounted prices.
                    (C) Criteria.--The Secretary shall make 
                available to all manufacturers of covered 
                outpatient drugs a description of the criteria 
                for certification under this paragraph.
                    (D) List of purchasers and dispensers.--The 
                certification process developed by the 
                Secretary under subparagraph (A) shall include 
                procedures under which each State shall, not 
                later than 30 days after the submission of the 
                descriptions under subparagraph (C), prepare 
                and submit a report to the Secretary that 
                contains a list of entities described in 
                subparagraphs (J) and (K) of paragraph (4) that 
                are located in the State.
                    (E) Recertification.--The Secretary shall 
                require the recertification of entities 
                certified pursuant to this paragraph on a not 
                more frequent than annual basis, and shall 
                require that such entities submit information 
                to the Secretary to permit the Secretary to 
                evaluate the validity of subsequent purchases 
                by such entities in the same manner as that 
                required under subparagraph (B).
            (8) Development of prime vendor program.--The 
        Secretary shall establish a prime vendor program under 
        which covered entities may enter into contracts with 
        prime vendors for the distribution of covered 
        outpatient drugs. If a covered entity obtains drugs 
        directly from a manufacturer, the manufacturer shall be 
        responsible for the costs of distribution.
            (9) Notice to manufacturers.--The Secretary shall 
        notify manufacturers of covered outpatient drugs and 
        single State agencies under section 1902(a)(5) of the 
        Social Security Act of the identities of covered 
        entities under this paragraph, and of entities that no 
        longer meet the requirements of paragraph (5) or that 
        are no longer certified pursuant to paragraph (7).
            (10) No prohibition on larger discount.--Nothing in 
        this subsection shall prohibit a manufacturer from 
        charging a price for a drug that is lower than the 
        maximum price that may be charged under paragraph (1).
    (b) Other Definitions \1\.--
---------------------------------------------------------------------------
    \1\ The amendment made by section 7101(b)(2)(A) of Public Law 111-
148 strikes ``Other Definition'' and all that follows through ``In this 
section'' and inserts ``Other Definitions.--
---------------------------------------------------------------------------

          (1) In general.--In this section''.

    The heading of such amendment should have been to strike ``Other 
Definitions''. The amendment made by such section has been carried out 
to reflect the probable intent of Congress.
---------------------------------------------------------------------------
            (1) In general.--In this section, the terms 
        ``average manufacturer price'', ``covered outpatient 
        drug'', and ``manufacturer'' have the meaning given 
        such terms in section 1927(k) of the Social Security 
        Act.
            (2) \2\ Covered drug.--In this section, the term 
        ``covered drug''--
---------------------------------------------------------------------------
    \2\ There are no references to the term ``covered drug'' in this 
section.
---------------------------------------------------------------------------
                    (A) means a covered outpatient drug (as 
                defined in section 1927(k)(2) of the Social 
                Security Act); and
                    (B) includes, notwithstanding paragraph 
                (3)(A) of section 1927(k) of such Act, a drug 
                used in connection with an inpatient or 
                outpatient service provided by a hospital 
                described in subparagraph (L), (M), (N), or (O) 
                of subsection (a)(4) that is enrolled to 
                participate in the drug discount program under 
                this section.
    (d) \3\ Improvements in Program Integrity.--
---------------------------------------------------------------------------
    \3\ In law, there is no subsection (c) in section 340B of the 
Public Health Service Act. Subsection (d) of section 340B of the Public 
Health Service, as in effect before the enactment of Public Law 111-
148, was redesignated as subsection (c) by section 2501(f)(1)(C) of 
Public Law 111-148, amended to read by section 7101(d) of Public Law 
111-148, and stricken by section 2302(2) of Public Law 111-152. 
Subsection (d) of section 340B of the Public Health Service, as 
currently in effect, is shown according to the probable intent of the 
Congress. Section 7102(a) of Public Law 111-148 does not execute 
because it amends to read a nonexistent subsection (d). Notably, 
section 2302(3) of Public Law 111-152 assumes that section 7102(a) of 
Public Law 111-148 executed properly and makes amendments to subsection 
(d).
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            (1) Manufacturer compliance.--
                    (A) In general.--From amounts appropriated 
                under paragraph (4), the Secretary shall 
                provide for improvements in compliance by 
                manufacturers with the requirements of this 
                section in order to prevent overcharges and 
                other violations of the discounted pricing 
                requirements specified in this section.
                    (B) Improvements.--The improvements 
                described in subparagraph (A) shall include the 
                following:
                            (i) The development of a system to 
                        enable the Secretary to verify the 
                        accuracy of ceiling prices calculated 
                        by manufacturers under subsection 
                        (a)(1) and charged to covered entities, 
                        which shall include the following:
                                    (I) Developing and 
                                publishing through an 
                                appropriate policy or 
                                regulatory issuance, precisely 
                                defined standards and 
                                methodology for the calculation 
                                of ceiling prices under such 
                                subsection.
                                    (II) Comparing regularly 
                                the ceiling prices calculated 
                                by the Secretary with the 
                                quarterly pricing data that is 
                                reported by manufacturers to 
                                the Secretary.
                                    (III) Performing spot 
                                checks of sales transactions by 
                                covered entities.
                                    (IV) Inquiring into the 
                                cause of any pricing 
                                discrepancies that may be 
                                identified and either taking, 
                                or requiring manufacturers to 
                                take, such corrective action as 
                                is appropriate in response to 
                                such price discrepancies.
                            (ii) The establishment of 
                        procedures for manufacturers to issue 
                        refunds to covered entities in the 
                        event that there is an overcharge by 
                        the manufacturers, including the 
                        following:
                                    (I) Providing the Secretary 
                                with an explanation of why and 
                                how the overcharge occurred, 
                                how the refunds will be 
                                calculated, and to whom the 
                                refunds will be issued.
                                    (II) Oversight by the 
                                Secretary to ensure that the 
                                refunds are issued accurately 
                                and within a reasonable period 
                                of time, both in routine 
                                instances of retroactive 
                                adjustment to relevant pricing 
                                data and exceptional 
                                circumstances such as erroneous 
                                or intentional overcharging for 
                                covered outpatient drugs.
                            (iii) The provision of access 
                        through the Internet website of the 
                        Department of Health and Human Services 
                        to the applicable ceiling prices for 
                        covered outpatient drugs as calculated 
                        and verified by the Secretary in 
                        accordance with this section, in a 
                        manner (such as through the use of 
                        password protection) that limits such 
                        access to covered entities and 
                        adequately assures security and 
                        protection of privileged pricing data 
                        from unauthorized re-disclosure.
                            (iv) The development of a mechanism 
                        by which--
                                    (I) rebates and other 
                                discounts provided by 
                                manufacturers to other 
                                purchasers subsequent to the 
                                sale of covered outpatient 
                                drugs to covered entities are 
                                reported to the Secretary; and
                                    (II) appropriate credits 
                                and refunds are issued to 
                                covered entities if such 
                                discounts or rebates have the 
                                effect of lowering the 
                                applicable ceiling price for 
                                the relevant quarter for the 
                                drugs involved.
                            (v) Selective auditing of 
                        manufacturers and wholesalers to ensure 
                        the integrity of the drug discount 
                        program under this section.
                            (vi) The imposition of sanctions in 
                        the form of civil monetary penalties, 
                        which--
                                    (I) shall be assessed 
                                according to standards 
                                established in regulations to 
                                be promulgated by the Secretary 
                                not later than 180 days after 
                                the date of enactment of the 
                                Patient Protection and 
                                Affordable Care Act;
                                    (II) shall not exceed 
                                $5,000 for each instance of 
                                overcharging a covered entity 
                                that may have occurred; and
                                    (III) shall apply to any 
                                manufacturer with an agreement 
                                under this section that 
                                knowingly and intentionally 
                                charges a covered entity a 
                                price for purchase of a drug 
                                that exceeds the maximum 
                                applicable price under 
                                subsection (a)(1).
            (2) Covered entity compliance.--
                    (A) In general.--From amounts appropriated 
                under paragraph (4), the Secretary shall 
                provide for improvements in compliance by 
                covered entities with the requirements of this 
                section in order to prevent diversion and 
                violations of the duplicate discount provision 
                and other requirements specified under 
                subsection (a)(5).
                    (B) Improvements.--The improvements 
                described in subparagraph (A) shall include the 
                following:
                            (i) The development of procedures 
                        to enable and require covered entities 
                        to regularly update (at least annually) 
                        the information on the Internet website 
                        of the Department of Health and Human 
                        Services relating to this section.
                            (ii) The development of a system 
                        for the Secretary to verify the 
                        accuracy of information regarding 
                        covered entities that is listed on the 
                        website described in clause (i).
                            (iii) The development of more 
                        detailed guidance describing 
                        methodologies and options available to 
                        covered entities for billing covered 
                        outpatient drugs to State Medicaid 
                        agencies in a manner that avoids 
                        duplicate discounts pursuant to 
                        subsection (a)(5)(A).
                            (iv) The establishment of a single, 
                        universal, and standardized 
                        identification system by which each 
                        covered entity site can be identified 
                        by manufacturers, distributors, covered 
                        entities, and the Secretary for 
                        purposes of facilitating the ordering, 
                        purchasing, and delivery of covered 
                        outpatient drugs under this section, 
                        including the processing of chargebacks 
                        for such drugs.
                            (v) The imposition of sanctions, in 
                        appropriate cases as determined by the 
                        Secretary, additional to those to which 
                        covered entities are subject under 
                        subsection (a)(5)(D), through one or 
                        more of the following actions:
                                    (I) Where a covered entity 
                                knowingly and intentionally 
                                violates subsection (a)(5)(B), 
                                the covered entity shall be 
                                required to pay a monetary 
                                penalty to a manufacturer or 
                                manufacturers in the form of 
                                interest on sums for which the 
                                covered entity is found liable 
                                under subsection (a)(5)(D), 
                                such interest to be compounded 
                                monthly and equal to the 
                                current short term interest 
                                rate as determined by the 
                                Federal Reserve for the time 
                                period for which the covered 
                                entity is liable.
                                    (II) Where the Secretary 
                                determines a violation of 
                                subsection (a)(5)(B) was 
                                systematic and egregious as 
                                well as knowing and 
                                intentional, removing the 
                                covered entity from the drug 
                                discount program under this 
                                section and disqualifying the 
                                entity from re-entry into such 
                                program for a reasonable period 
                                of time to be determined by the 
                                Secretary.
                                    (III) Referring matters to 
                                appropriate Federal authorities 
                                within the Food and Drug 
                                Administration, the Office of 
                                Inspector General of Department 
                                of Health and Human Services, 
                                or other Federal agencies for 
                                consideration of appropriate 
                                action under other Federal 
                                statutes, such as the 
                                Prescription Drug Marketing Act 
                                (21 U.S.C. 353).
            (3) Administrative dispute resolution process.--
                    (A) In general.--Not later than 180 days 
                after the date of enactment of the Patient 
                Protection and Affordable Care Act, the 
                Secretary shall promulgate regulations to 
                establish and implement an administrative 
                process for the resolution of claims by covered 
                entities that they have been overcharged for 
                drugs purchased under this section, and claims 
                by manufacturers, after the conduct of audits 
                as authorized by subsection (a)(5)(C), of 
                violations of subsections (a)(5)(A) or 
                (a)(5)(B), including appropriate procedures for 
                the provision of remedies and enforcement of 
                determinations made pursuant to such process 
                through mechanisms and sanctions described in 
                paragraphs (1)(B) and (2)(B).
                    (B) Deadlines and procedures.--Regulations 
                promulgated by the Secretary under subparagraph 
                (A) shall--
                            (i) designate or establish a 
                        decision-making official or decision-
                        making body within the Department of 
                        Health and Human Services to be 
                        responsible for reviewing and finally 
                        resolving claims by covered entities 
                        that they have been charged prices for 
                        covered outpatient drugs in excess of 
                        the ceiling price described in 
                        subsection (a)(1), and claims by 
                        manufacturers that violations of 
                        subsection (a)(5)(A) or (a)(5)(B) have 
                        occurred;
                            (ii) establish such deadlines and 
                        procedures as may be necessary to 
                        ensure that claims shall be resolved 
                        fairly, efficiently, and expeditiously;
                            (iii) establish procedures by which 
                        a covered entity may discover and 
                        obtain such information and documents 
                        from manufacturers and third parties as 
                        may be relevant to demonstrate the 
                        merits of a claim that charges for a 
                        manufacturer's product have exceeded 
                        the applicable ceiling price under this 
                        section, and may submit such documents 
                        and information to the administrative 
                        official or body responsible for 
                        adjudicating such claim;
                            (iv) require that a manufacturer 
                        conduct an audit of a covered entity 
                        pursuant to subsection (a)(5)(C) as a 
                        prerequisite to initiating 
                        administrative dispute resolution 
                        proceedings against a covered entity;
                            (v) permit the official or body 
                        designated under clause (i), at the 
                        request of a manufacturer or 
                        manufacturers, to consolidate claims 
                        brought by more than one manufacturer 
                        against the same covered entity where, 
                        in the judgment of such official or 
                        body, consolidation is appropriate and 
                        consistent with the goals of fairness 
                        and economy of resources; and
                            (vi) include provisions and 
                        procedures to permit multiple covered 
                        entities to jointly assert claims of 
                        overcharges by the same manufacturer 
                        for the same drug or drugs in one 
                        administrative proceeding, and permit 
                        such claims to be asserted on behalf of 
                        covered entities by associations or 
                        organizations representing the 
                        interests of such covered entities and 
                        of which the covered entities are 
                        members.
                    (C) Finality of administrative 
                resolution.--The administrative resolution of a 
                claim or claims under the regulations 
                promulgated under subparagraph (A) shall be a 
                final agency decision and shall be binding upon 
                the parties involved, unless invalidated by an 
                order of a court of competent jurisdiction.
            (4) Authorization of appropriations.--There are 
        authorized to be appropriated to carry out this 
        subsection, such sums as may be necessary for fiscal 
        year 2010 and each succeeding fiscal year.
    (e) \1\ Exclusion of Orphan Drugs for Certain Covered 
Entities.--For covered entities described in subparagraph (M) 
(other than a children's hospital described in subparagraph 
(M)), (N), or (O) of subsection (a)(4), the term ``covered 
outpatient drug'' shall not include a drug designated by the 
Secretary under section 526 of the Federal Food, Drug, and 
Cosmetic Act for a rare disease or condition.
---------------------------------------------------------------------------
    \1\ Subsection (e) is shown according to the probable intent of 
Congress. Section 2302(4) of Public Law 111-152 inserts subsection (e) 
``after subsection (d)''. See note in section 340B(d) of the Public 
Health Service Act regarding the inclusion of subsection (d) to reflect 
the probable intent of Congress.
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     Subpart VIII--Bulk Purchases of Vaccines for Certain Programs

            bulk purchases of vaccines for certain programs
    Sec. 340C. [256c] (a) Agreements for Purchases.--
            (1) In general.--Not later than 180 days after the 
        date of the enactment of the Preventive Health 
        Amendments of 1992 \1\, the Secretary, acting through 
        the Director of the Centers for Disease Control and 
        Prevention and in consultation with the Administrator 
        of the Health Resources and Services Administration, 
        shall enter into negotiations with manufacturers of 
        vaccines for the purpose of establishing and 
        maintaining agreements under which entities described 
        in paragraph (2) may purchase vaccines from the 
        manufacturers at the prices specified in the 
        agreements.
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    \1\ Enacted October 27, 1992.
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            (2) Relevant entities.--The entities referred to in 
        paragraph (1) are entities that provide immunizations 
        against vaccine-preventable diseases with assistance 
        provided under section 330.
    (b) Negotiation of Prices.--In carrying out subsection (a), 
the Secretary shall, to the extent practicable, ensure that the 
prices provided for in agreements under such subsection are 
comparable to the prices provided for in agreements negotiated 
by the Secretary on behalf of grantees under section 317(j)(1).
    (c) Authority of Secretary.--In carrying out subsection 
(a), the Secretary, in the discretion of the Secretary, may 
enter into the agreements described in such subsection (and may 
decline to enter into such agreements), may modify such 
agreements, may extend such agreements, and may terminate such 
agreements.
    (d) Rule of Construction.--This section may not be 
construed as requiring any State to reduce or terminate the 
supply of vaccines provided by the State to any of the entities 
described in subsection (a)(2).
                 breast and cervical cancer information
    Sec. 340D. [256d] (a) In General.--As a condition of 
receiving grants, cooperative agreements, or contracts under 
this Act, each of the entities specified in subsection (c) 
shall, to the extent determined to be appropriate by the 
Secretary, make available information concerning breast and 
cervical cancer.
    (b) Certain Authorities.--In carrying out subsection (a), 
an entity specified in subsection (c)--
            (1) may make the information involved available to 
        such individuals as the entity determines appropriate;
            (2) may, as appropriate, provide information under 
        subsection (a) on the need for self-examination of the 
        breasts and on the skills for such self-examinations;
            (3) shall provide information under subsection (a) 
        in the language and cultural context most appropriate 
        to the individuals to whom the information is provided; 
        and
            (4) shall refer such clients as the entities 
        determine appropriate for breast and cervical cancer 
        screening, treatment, or other appropriate services.
    (c) Relevant Entities.--The entities specified in this 
subsection are the following:
            (1) Entities receiving assistance under section 
        317F (relating to tuberculosis) \1\.
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    \1\ The reference to section 317F is so in law. See section 2502(b) 
of Public Law 106-310 (114 Stat. 1163). Section 317E relates to 
tuberculosis, not section 317F.
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            (2) Entities receiving assistance under section 318 
        (relating to sexually transmitted diseases).
            (3) Migrant health centers receiving assistance 
        under section 329 \2\.
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    \2\ See footnote for section 217(a).
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            (4) Community health centers receiving assistance 
        under section 330 \2\.
            (5) Entities receiving assistance under section 
        330(h) (relating to homeless individuals).
            (6) Entities receiving assistance under section 
        340A \2\ (relating to health services for residents of 
        public housing).
            (7) Entities providing services with assistance 
        under title V or title XIX.
            (8) Entities receiving assistance under section 
        1001 (relating to family planning).
            (9) Entities receiving assistance under title XXVI 
        (relating to services with respect to acquired immune 
        deficiency syndrome).
            (10) Non-Federal entities authorized under the 
        Indian Self-Determination Act.

     Subpart IX--Support of Graduate Medical Education Programs in 
                          Children's Hospitals

SEC. 340E. [256E] PROGRAM OF PAYMENTS TO CHILDREN'S HOSPITALS THAT 
                    OPERATE GRADUATE MEDICAL EDUCATION PROGRAMS.

    (a) Payments.--The Secretary shall make two payments under 
this section to each children's hospital for each of fiscal 
years 2000 through 2005 and each of fiscal years 2007 through 
2011, one for the direct expenses and the other for indirect 
expenses associated with operating approved graduate medical 
residency training programs. The Secretary shall promulgate 
regulations pursuant to the rulemaking requirements of title 5, 
United States Code, which shall govern payments made under this 
subpart.
    (b) Amount of Payments.--
            (1) In general.--Subject to paragraphs (2) and (3), 
        the amounts payable under this section to a children's 
        hospital for an approved graduate medical residency 
        training program for a fiscal year are each of the 
        following amounts:
                    (A) Direct expense amount.--The amount 
                determined under subsection (c) for direct 
                expenses associated with operating approved 
                graduate medical residency training programs.
                    (B) Indirect expense amount.--The amount 
                determined under subsection (d) for indirect 
                expenses associated with the treatment of more 
                severely ill patients and the additional costs 
                relating to teaching residents in such 
                programs.
            (2) Capped amount.--
                    (A) In general.--The total of the payments 
                made to children's hospitals under paragraph 
                (1)(A) or paragraph (1)(B) in a fiscal year 
                shall not exceed the funds appropriated under 
                paragraph (1) or (2), respectively, of 
                subsection (f) for such payments for that 
                fiscal year.
                    (B) Pro rata reductions of payments for 
                direct expenses.--If the Secretary determines 
                that the amount of funds appropriated under 
                subsection (f)(1) for a fiscal year is 
                insufficient to provide the total amount of 
                payments otherwise due for such periods under 
                paragraph (1)(A), the Secretary shall reduce 
                the amounts so payable on a pro rata basis to 
                reflect such shortfall.
            (3) Annual reporting required.--
                    (A) Reduction in payment for failure to 
                report.--
                            (i) In general.--The amount payable 
                        under this section to a children's 
                        hospital for a fiscal year (beginning 
                        with fiscal year 2008 and after taking 
                        into account paragraph (2)) shall be 
                        reduced by 25 percent if the Secretary 
                        determines that--
                                    (I) the hospital has failed 
                                to provide the Secretary, as an 
                                addendum to the hospital's 
                                application under this section 
                                for such fiscal year, the 
                                report required under 
                                subparagraph (B) for the 
                                previous fiscal year; or
                                    (II) such report fails to 
                                provide the information 
                                required under any clause of 
                                such subparagraph.
                            (ii) Notice and opportunity to 
                        provide missing information.--Before 
                        imposing a reduction under clause (i) 
                        on the basis of a hospital's failure to 
                        provide information described in clause 
                        (i)(II), the Secretary shall provide 
                        notice to the hospital of such failure 
                        and the Secretary's intention to impose 
                        such reduction and shall provide the 
                        hospital with the opportunity to 
                        provide the required information within 
                        a period of 30 days beginning on the 
                        date of such notice. If the hospital 
                        provides such information within such 
                        period, no reduction shall be made 
                        under clause (i) on the basis of the 
                        previous failure to provide such 
                        information.
                    (B) Annual report.--The report required 
                under this subparagraph for a children's 
                hospital for a fiscal year is a report that 
                includes (in a form and manner specified by the 
                Secretary) the following information for the 
                residency academic year completed immediately 
                prior to such fiscal year:
                            (i) The types of resident training 
                        programs that the hospital provided for 
                        residents described in subparagraph 
                        (C), such as general pediatrics, 
                        internal medicine/pediatrics, and 
                        pediatric subspecialties, including 
                        both medical subspecialties certified 
                        by the American Board of Pediatrics 
                        (such as pediatric gastroenterology) 
                        and non-medical subspecialties approved 
                        by other medical certification boards 
                        (such as pediatric surgery).
                            (ii) The number of training 
                        positions for residents described in 
                        subparagraph (C), the number of such 
                        positions recruited to fill, and the 
                        number of such positions filled.
                            (iii) The types of training that 
                        the hospital provided for residents 
                        described in subparagraph (C) related 
                        to the health care needs of different 
                        populations, such as children who are 
                        underserved for reasons of family 
                        income or geographic location, 
                        including rural and urban areas.
                            (iv) The changes in residency 
                        training for residents described in 
                        subparagraph (C) which the hospital has 
                        made during such residency academic 
                        year (except that the first report 
                        submitted by the hospital under this 
                        subparagraph shall be for such changes 
                        since the first year in which the 
                        hospital received payment under this 
                        section), including--
                                    (I) changes in curricula, 
                                training experiences, and types 
                                of training programs, and 
                                benefits that have resulted 
                                from such changes; and
                                    (II) changes for purposes 
                                of training the residents in 
                                the measurement and improvement 
                                of the quality and safety of 
                                patient care.
                            (v) The numbers of residents 
                        described in subparagraph (C) who 
                        completed their residency training at 
                        the end of such residency academic year 
                        and care for children within the 
                        borders of the service area of the 
                        hospital or within the borders of the 
                        State in which the hospital is located. 
                        Such numbers shall be disaggregated 
                        with respect to residents who completed 
                        residencies in general pediatrics or 
                        internal medicine/pediatrics, 
                        subspecialty residencies, and dental 
                        residencies.
                    (C) Residents.--The residents described in 
                this subparagraph are those who--
                            (i) are in full-time equivalent 
                        resident training positions in any 
                        training program sponsored by the 
                        hospital; or
                            (ii) are in a training program 
                        sponsored by an entity other than the 
                        hospital, but who spend more than 75 
                        percent of their training time at the 
                        hospital.
                    (D) Report to congress.--Not later than the 
                end of fiscal year 2011, the Secretary, acting 
                through the Administrator of the Health 
                Resources and Services Administration, shall 
                submit a report to the Congress--
                            (i) summarizing the information 
                        submitted in reports to the Secretary 
                        under subparagraph (B);
                            (ii) describing the results of the 
                        program carried out under this section; 
                        and
                            (iii) making recommendations for 
                        improvements to the program.
    (c) Amount of Payment for Direct Graduate Medical 
Education.--
            (1) In general.--The amount determined under this 
        subsection for payments to a children's hospital for 
        direct graduate expenses relating to approved graduate 
        medical residency training programs for a fiscal year 
        is equal to the product of--
                    (A) the updated per resident amount for 
                direct graduate medical education, as 
                determined under paragraph (2); and
                    (B) the average number of full-time 
                equivalent residents in the hospital's graduate 
                approved medical residency training programs 
                (as determined under section 1886(h)(4) of the 
                Social Security Act during the fiscal year.
            (2) Updated per resident amount for direct graduate 
        medical education.--The updated per resident amount for 
        direct graduate medical education for a hospital for a 
        fiscal year is an amount determined as follows:
                    (A) Determination of hospital single per 
                resident amount.--The Secretary shall compute 
                for each hospital operating an approved 
                graduate medical education program (regardless 
                of whether or not it is a children's hospital) 
                a single per resident amount equal to the 
                average (weighted by number of full-time 
                equivalent residents) of the primary care per 
                resident amount and the non-primary care per 
                resident amount computed under section 
                1886(h)(2) of the Social Security Act for cost 
                reporting periods ending during fiscal year 
                1997.
                    (B) Determination of wage and non-wage-
                related proportion of the single per resident 
                amount.--The Secretary shall estimate the 
                average proportion of the single per resident 
                amounts computed under subparagraph (A) that is 
                attributable to wages and wage-related costs.
                    (C) Standardizing per resident amounts.--
                The Secretary shall establish a standardized 
                per resident amount for each such hospital--
                            (i) by dividing the single per 
                        resident amount computed under 
                        subparagraph (A) into a wage-related 
                        portion and a non-wage-related portion 
                        by applying the proportion determined 
                        under subparagraph (B);
                            (ii) by dividing the wage-related 
                        portion by the factor applied under 
                        section 1886(d)(3)(E) of the Social 
                        Security Act for discharges occurring 
                        during fiscal year 1999 for the 
                        hospital's area; and
                            (iii) by adding the non-wage-
                        related portion to the amount computed 
                        under clause (ii).
                    (D) Determination of national average.--The 
                Secretary shall compute a national average per 
                resident amount equal to the average of the 
                standardized per resident amounts computed 
                under subparagraph (C) for such hospitals, with 
                the amount for each hospital weighted by the 
                average number of full-time equivalent 
                residents at such hospital.
                    (E) Application to individual hospitals.--
                The Secretary shall compute for each such 
                hospital that is a children's hospital a per 
                resident amount--
                            (i) by dividing the national 
                        average per resident amount computed 
                        under subparagraph (D) into a wage-
                        related portion and a non-wage-related 
                        portion by applying the proportion 
                        determined under subparagraph (B);
                            (ii) by multiplying the wage-
                        related portion by the factor applied 
                        under section 1886(d)(3)(E) of the 
                        Social Security Act for discharges 
                        occurring during the preceding fiscal 
                        year for the hospital's area; and
                            (iii) by adding the non-wage-
                        related portion to the amount computed 
                        under clause (ii).
                    (F) Updating rate.--The Secretary shall 
                update such per resident amount for each such 
                children's hospital by the estimated percentage 
                increase in the consumer price index for all 
                urban consumers during the period beginning 
                October 1997 and ending with the midpoint of 
                the Federal fiscal year for which payments are 
                made.
    (d) Amount of Payment for Indirect Medical Education.--
            (1) In general.--The amount determined under this 
        subsection for payments to a children's hospital for 
        indirect expenses associated with the treatment of more 
        severely ill patients and the additional costs 
        associated with the teaching of residents for a fiscal 
        year is equal to an amount determined appropriate by 
        the Secretary.
            (2) Factors.--In determining the amount under 
        paragraph (1), the Secretary shall--
                    (A) take into account variations in case 
                mix among children's hospitals and the ratio of 
                the number of full-time equivalent residents in 
                the hospitals' approved graduate medical 
                residency training programs to beds (but 
                excluding beds or bassinets assigned to healthy 
                newborn infants); and
                    (B) assure that the aggregate of the 
                payments for indirect expenses associated with 
                the treatment of more severely ill patients and 
                the additional costs related to the teaching of 
                residents under this section in a fiscal year 
                are equal to the amount appropriated for such 
                expenses for the fiscal year involved under 
                subsection (f)(2).
    (e) Making of Payments.--
            (1) Interim payments.--The Secretary shall 
        determine, before the beginning of each fiscal year 
        involved for which payments may be made for a hospital 
        under this section, the amounts of the payments for 
        direct graduate medical education and indirect medical 
        education for such fiscal year and shall (subject to 
        paragraph (2)) make the payments of such amounts in 12 
        equal interim installments during such period. Such 
        interim payments to each individual hospital shall be 
        based on the number of residents reported in the 
        hospital's most recently filed Medicare cost report 
        prior to the application date for the Federal fiscal 
        year for which the interim payment amounts are 
        established. In the case of a hospital that does not 
        report residents on a Medicare cost report, such 
        interim payments shall be based on the number of 
        residents trained during the hospital's most recently 
        completed Medicare cost report filing period.
            (2) Withholding.--The Secretary shall withhold up 
        to 25 percent from each interim installment for direct 
        and indirect graduate medical education paid under 
        paragraph (1) as necessary to ensure a hospital will 
        not be overpaid on an interim basis.
            (3) Reconciliation.--Prior to the end of each 
        fiscal year, the Secretary shall determine any changes 
        to the number of residents reported by a hospital in 
        the application of the hospital for the current fiscal 
        year to determine the final amount payable to the 
        hospital for the current fiscal year for both direct 
        expense and indirect expense amounts. Based on such 
        determination, the Secretary shall recoup any 
        overpayments made and pay any balance due to the extent 
        possible. The final amount so determined shall be 
        considered a final intermediary determination for the 
        purposes of section 1878 of the Social Security Act and 
        shall be subject to administrative and judicial review 
        under that section in the same manner as the amount of 
        payment under section 1186(d) of such Act is subject to 
        review under such section.
    (f) Authorization of Appropriations.--
            (1) Direct graduate medical education.--
                    (A) In general.--There are hereby 
                authorized to be appropriated, out of any money 
                in the Treasury not otherwise appropriated, for 
                payments under subsection (b)(1)(A)--
                            (i) for fiscal year 2000, 
                        $90,000,000;
                            (ii) for fiscal year 2001, 
                        $95,000,000;
                            (iii) for each of the fiscal years 
                        2002 through 2005, such sums as may be 
                        necessary; and
                            (iv) for each of fiscal years 2007 
                        through 2011, $110,000,000.
                    (B) Carryover of excess.--The amounts 
                appropriated under subparagraph (A) for fiscal 
                year 2000 shall remain available for obligation 
                through the end of fiscal year 2001.
            (2) Indirect medical education.--There are hereby 
        authorized to be appropriated, out of any money in the 
        Treasury not otherwise appropriated, for payments under 
        subsection (b)(1)(B)--
                    (A) for fiscal year 2000, $190,000,000;
                    (B) for fiscal year 2001, $190,000,000;
                    (C) for each of the fiscal years 2002 
                through 2005, such sums as may be necessary; 
                and
                    (D) for each of fiscal years 2007 through 
                2011, $220,000,000.
    (g) Definitions.--In this section:
            (1) Approved graduate medical residency training 
        program.--The term ``approved graduate medical 
        residency training program'' has the meaning given the 
        term ``approved medical residency training program'' in 
        section 1886(h)(5)(A) of the Social Security Act.
            (2) Children's hospital.--The term ``children's 
        hospital'' means a hospital with a Medicare payment 
        agreement and which is excluded from the Medicare 
        inpatient prospective payment system pursuant to 
        section 1886(d)(1)(B)(iii) of the Social Security Act 
        and its accompanying regulations.
            (3) Direct graduate medical education costs.--The 
        term ``direct graduate medical education costs'' has 
        the meaning given such term in section 1886(h)(5)(C) of 
        the Social Security Act.

                   Subpart X--Primary Dental Programs

SEC. 340F. [256F] DESIGNATED DENTAL HEALTH PROFESSIONAL SHORTAGE AREA.

    In this subpart, the term ``designated dental health 
professional shortage area'' means an area, population group, 
or facility that is designated by the Secretary as a dental 
health professional shortage area under section 332 or 
designated by the applicable State as having a dental health 
professional shortage.

SEC. 340G. [256G] GRANTS FOR INNOVATIVE PROGRAMS.

    (a) Grant Program Authorized.--The Secretary, acting 
through the Administrator of the Health Resources and Services 
Administration, is authorized to award grants to States for the 
purpose of helping States develop and implement innovative 
programs to address the dental workforce needs of designated 
dental health professional shortage areas in a manner that is 
appropriate to the States' individual needs.
    (b) State Activities.--A State receiving a grant under 
subsection (a) may use funds received under the grant for--
            (1) loan forgiveness and repayment programs for 
        dentists who--
                    (A) agree to practice in designated dental 
                health professional shortage areas;
                    (B) are dental school graduates who agree 
                to serve as public health dentists for the 
                Federal, State, or local government; and
                    (C) agree to--
                            (i) provide services to patients 
                        regardless of such patients' ability to 
                        pay; and
                            (ii) use a sliding payment scale 
                        for patients who are unable to pay the 
                        total cost of services;
            (2) dental recruitment and retention efforts;
            (3) grants and low-interest or no-interest loans to 
        help dentists who participate in the medicaid program 
        under title XIX of the Social Security Act (42 U.S.C. 
        1396 et seq.) to establish or expand practices in 
        designated dental health professional shortage areas by 
        equipping dental offices or sharing in the overhead 
        costs of such practices;
            (4) the establishment or expansion of dental 
        residency programs in coordination with accredited 
        dental training institutions in States without dental 
        schools;
            (5) programs developed in consultation with State 
        and local dental societies to expand or establish oral 
        health services and facilities in designated dental 
        health professional shortage areas, including services 
        and facilities for children with special needs, such 
        as--
                    (A) the expansion or establishment of a 
                community-based dental facility, free-standing 
                dental clinic, consolidated health center 
                dental facility, school-linked dental facility, 
                or United States dental school-based facility;
                    (B) the establishment of a mobile or 
                portable dental clinic; and
                    (C) the establishment or expansion of 
                private dental services to enhance capacity 
                through additional equipment or additional 
                hours of operation;
            (6) placement and support of dental students, 
        dental residents, and advanced dentistry trainees;
            (7) continuing dental education, including 
        distance-based education;
            (8) practice support through teledentistry 
        conducted in accordance with State laws;
            (9) community-based prevention services such as 
        water fluoridation and dental sealant programs;
            (10) coordination with local educational agencies 
        within the State to foster programs that promote 
        children going into oral health or science professions;
            (11) the establishment of faculty recruitment 
        programs at accredited dental training institutions 
        whose mission includes community outreach and service 
        and that have a demonstrated record of serving 
        underserved States;
            (12) the development of a State dental officer 
        position or the augmentation of a State dental office 
        to coordinate oral health and access issues in the 
        State; and
            (13) any other activities determined to be 
        appropriate by the Secretary.
    (c) Application.--
            (1) In general.--Each State desiring a grant under 
        this section shall submit an application to the 
        Secretary at such time, in such manner, and containing 
        such information as the Secretary may reasonably 
        require.
            (2) Assurances.--The application shall include 
        assurances that the State will meet the requirements of 
        subsection (d) and that the State possesses sufficient 
        infrastructure to manage the activities to be funded 
        through the grant and to evaluate and report on the 
        outcomes resulting from such activities.
    (d) Matching Requirement.--The Secretary may not make a 
grant to a State under this section unless that State agrees 
that, with respect to the costs to be incurred by the State in 
carrying out the activities for which the grant was awarded, 
the State will provide non-Federal contributions in an amount 
equal to not less than 40 percent of Federal funds provided 
under the grant. The State may provide the contributions in 
cash or in kind, fairly evaluated, including plant, equipment, 
and services and may provide the contributions from State, 
local, or private sources.
    (e) Report.--Not later than 5 years after the date of 
enactment of the Health Care Safety Net Amendments of 2002, the 
Secretary shall prepare and submit to the appropriate 
committees of Congress a report containing data relating to 
whether grants provided under this section have increased 
access to dental services in designated dental health 
professional shortage areas.
    (f) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section, $25,000,000 for 
the 5-fiscal year period beginning with fiscal year 2008.

SEC. 340G-1. [256G-1] DEMONSTRATION PROGRAM.

    (a) In General.--
            (1) Authorization.--The Secretary is authorized to 
        award grants to 15 eligible entities to enable such 
        entities to establish a demonstration program to 
        establish training programs to train, or to employ, 
        alternative dental health care providers in order to 
        increase access to dental health care services in rural 
        and other underserved communities.
            (2) Definition.--The term ``alternative dental 
        health care providers'' includes community dental 
        health coordinators, advance practice dental 
        hygienists, independent dental hygienists, supervised 
        dental hygienists, primary care physicians, dental 
        therapists, dental health aides, and any other health 
        professional that the Secretary determines appropriate.
    (b) Timeframe.--The demonstration projects funded under 
this section shall begin not later than 2 years after the date 
of enactment of this section, and shall conclude not later than 
7 years after such date of enactment.
    (c) Eligible Entities.--To be eligible to receive a grant 
under subsection (a), an entity shall--
            (1) be--
                    (A) an institution of higher education, 
                including a community college;
                    (B) a public-private partnership;
                    (C) a federally qualified health center;
                    (D) an Indian Health Service facility or a 
                tribe or tribal organization (as such terms are 
                defined in section 4 of the Indian Self-
                Determination and Education Assistance Act);
                    (E) a State or county public health clinic, 
                a health facility operated by an Indian tribe 
                or tribal organization, or urban Indian 
                organization providing dental services; or
                    (F) a public hospital or health system;
            (2) be within a program accredited by the 
        Commission on Dental Accreditation or within a dental 
        education program in an accredited institution; and
            (3) shall submit an application to the Secretary at 
        such time, in such manner, and containing such 
        information as the Secretary may require.
    (d) Administrative Provisions.--
            (1) Amount of grant.--Each grant under this section 
        shall be in an amount that is not less than $4,000,000 
        for the 5-year period during which the demonstration 
        project being conducted.
            (2) Disbursement of funds.--
                    (A) Preliminary disbursements.--Beginning 1 
                year after the enactment of this section, the 
                Secretary may disperse to any entity receiving 
                a grant under this section not more than 20 
                percent of the total funding awarded to such 
                entity under such grant, for the purpose of 
                enabling the entity to plan the demonstration 
                project to be conducted under such grant.
                    (B) Subsequent disbursements.--The 
                remaining amount of grant funds not dispersed 
                under subparagraph (A) shall be dispersed such 
                that not less than 15 percent of such remaining 
                amount is dispersed each subsequent year.
    (e) Compliance With State Requirements.--Each entity 
receiving a grant under this section shall certify that it is 
in compliance with all applicable State licensing requirements.
    (f) Evaluation.--The Secretary shall contract with the 
Director of the Institute of Medicine to conduct a study of the 
demonstration programs conducted under this section that shall 
provide analysis, based upon quantitative and qualitative data, 
regarding access to dental health care in the United States.
    (g) Clarification Regarding Dental Health Aide Program.--
Nothing in this section shall prohibit a dental health aide 
training program approved by the Indian Health Service from 
being eligible for a grant under this section.
    (h) Authorization of Appropriations.--There is authorized 
to be appropriated such sums as may be necessary to carry out 
this section.

Subpart XI--Support of Graduate Medical Education in Qualified Teaching 
                             Health Centers

SEC. 340H. [256H] PROGRAM OF PAYMENTS TO TEACHING HEALTH CENTERS THAT 
                    OPERATE GRADUATE MEDICAL EDUCATION PROGRAMS.

    (a) Payments.--Subject to subsection (h)(2), the Secretary 
shall make payments under this section for direct expenses and 
for indirect expenses to qualified teaching health centers that 
are listed as sponsoring institutions by the relevant 
accrediting body for expansion of existing or establishment of 
new approved graduate medical residency training programs.
    (b) Amount of Payments.--
            (1) In general.--Subject to paragraph (2), the 
        amounts payable under this section to qualified 
        teaching health centers for an approved graduate 
        medical residency training program for a fiscal year 
        are each of the following amounts:
                    (A) Direct expense amount.--The amount 
                determined under subsection (c) for direct 
                expenses associated with sponsoring approved 
                graduate medical residency training programs.
                    (B) Indirect expense amount.--The amount 
                determined under subsection (d) for indirect 
                expenses associated with the additional costs 
                relating to teaching residents in such 
                programs.
            (2) Capped amount.--
                    (A) In general.--The total of the payments 
                made to qualified teaching health centers under 
                paragraph (1)(A) or paragraph (1)(B) in a 
                fiscal year shall not exceed the amount of 
                funds appropriated under subsection (g) for 
                such payments for that fiscal year.
                    (B) Limitation.--The Secretary shall limit 
                the funding of full-time equivalent residents 
                in order to ensure the direct and indirect 
                payments as determined under subsection (c) and 
                (d) do not exceed the total amount of funds 
                appropriated in a fiscal year under subsection 
                (g).
    (c) Amount of Payment for Direct Graduate Medical 
Education.--
            (1) In general.--The amount determined under this 
        subsection for payments to qualified teaching health 
        centers for direct graduate expenses relating to 
        approved graduate medical residency training programs 
        for a fiscal year is equal to the product of--
                    (A) the updated national per resident 
                amount for direct graduate medical education, 
                as determined under paragraph (2); and
                    (B) the average number of full-time 
                equivalent residents in the teaching health 
                center's graduate approved medical residency 
                training programs as determined under section 
                1886(h)(4) of the Social Security Act (without 
                regard to the limitation under subparagraph (F) 
                of such section) during the fiscal year.
            (2) Updated national per resident amount for direct 
        graduate medical education.--The updated per resident 
        amount for direct graduate medical education for a 
        qualified teaching health center for a fiscal year is 
        an amount determined as follows:
                    (A) Determination of qualified teaching 
                health center per resident amount.--The 
                Secretary shall compute for each individual 
                qualified teaching health center a per resident 
                amount--
                            (i) by dividing the national 
                        average per resident amount computed 
                        under section 340E(c)(2)(D) into a 
                        wage-related portion and a non-wage 
                        related portion by applying the 
                        proportion determined under 
                        subparagraph (B);
                            (ii) by multiplying the wage-
                        related portion by the factor applied 
                        under section 1886(d)(3)(E) of the 
                        Social Security Act (but without 
                        application of section 4410 of the 
                        Balanced Budget Act of 1997 (42 U.S.C. 
                        1395ww note)) during the preceding 
                        fiscal year for the teaching health 
                        center's area; and
                            (iii) by adding the non-wage-
                        related portion to the amount computed 
                        under clause (ii).
                    (B) Updating rate.--The Secretary shall 
                update such per resident amount for each such 
                qualified teaching health center as determined 
                appropriate by the Secretary.
    (d) Amount of Payment for Indirect Medical Education.--
            (1) In general.--The amount determined under this 
        subsection for payments to qualified teaching health 
        centers for indirect expenses associated with the 
        additional costs of teaching residents for a fiscal 
        year is equal to an amount determined appropriate by 
        the Secretary.
            (2) Factors.--In determining the amount under 
        paragraph (1), the Secretary shall--
                    (A) evaluate indirect training costs 
                relative to supporting a primary care residency 
                program in qualified teaching health centers; 
                and
                    (B) based on this evaluation, assure that 
                the aggregate of the payments for indirect 
                expenses under this section and the payments 
                for direct graduate medical education as 
                determined under subsection (c) in a fiscal 
                year do not exceed the amount appropriated for 
                such expenses as determined in subsection (g).
            (3) Interim payment.--Before the Secretary makes a 
        payment under this subsection pursuant to a 
        determination of indirect expenses under paragraph (1), 
        the Secretary may provide to qualified teaching health 
        centers a payment, in addition to any payment made 
        under subsection (c), for expected indirect expenses 
        associated with the additional costs of teaching 
        residents for a fiscal year, based on an estimate by 
        the Secretary.
    (e) Clarification Regarding Relationship to Other Payments 
for Graduate Medical Education.--Payments under this section--
            (1) shall be in addition to any payments--
                    (A) for the indirect costs of medical 
                education under section 1886(d)(5)(B) of the 
                Social Security Act;
                    (B) for direct graduate medical education 
                costs under section 1886(h) of such Act; and
                    (C) for direct costs of medical education 
                under section 1886(k) of such Act;
            (2) shall not be taken into account in applying the 
        limitation on the number of total full-time equivalent 
        residents under subparagraphs (F) and (G) of section 
        1886(h)(4) of such Act and clauses (v), (vi)(I), and 
        (vi)(II) of section 1886(d)(5)(B) of such Act for the 
        portion of time that a resident rotates to a hospital; 
        and
            (3) shall not include the time in which a resident 
        is counted toward full-time equivalency by a hospital 
        under paragraph (2) or under section 1886(d)(5)(B)(iv) 
        of the Social Security Act, section 1886(h)(4)(E) of 
        such Act, or section 340E of this Act.
    (f) Reconciliation.--The Secretary shall determine any 
changes to the number of residents reported by a hospital in 
the application of the hospital for the current fiscal year to 
determine the final amount payable to the hospital for the 
current fiscal year for both direct expense and indirect 
expense amounts. Based on such determination, the Secretary 
shall recoup any overpayments made to pay any balance due to 
the extent possible. The final amount so determined shall be 
considered a final intermediary determination for the purposes 
of section 1878 of the Social Security Act and shall be subject 
to administrative and judicial review under that section in the 
same manner as the amount of payment under section 1186(d) of 
such Act is subject to review under such section.
    (g) Funding.--To carry out this section, there are 
appropriated such sums as may be necessary, not to exceed 
$230,000,000, for the period of fiscal years 2011 through 2015.
    (h) Annual Reporting Required.--
            (1) Annual report.--The report required under this 
        paragraph for a qualified teaching health center for a 
        fiscal year is a report that includes (in a form and 
        manner specified by the Secretary) the following 
        information for the residency academic year completed 
        immediately prior to such fiscal year:
                    (A) The types of primary care resident 
                approved training programs that the qualified 
                teaching health center provided for residents.
                    (B) The number of approved training 
                positions for residents described in paragraph 
                (4).
                    (C) The number of residents described in 
                paragraph (4) who completed their residency 
                training at the end of such residency academic 
                year and care for vulnerable populations living 
                in underserved areas.
                    (D) Other information as deemed appropriate 
                by the Secretary.
            (2) Audit authority; limitation on payment.--
                    (A) Audit authority.--The Secretary may 
                audit a qualified teaching health center to 
                ensure the accuracy and completeness of the 
                information submitted in a report under 
                paragraph (1).
                    (B) Limitation on payment.--A teaching 
                health center may only receive payment in a 
                cost reporting period for a number of such 
                resident positions that is greater than the 
                base level of primary care resident positions, 
                as determined by the Secretary. For purposes of 
                this subparagraph, the ``base level of primary 
                care residents'' for a teaching health center 
                is the level of such residents as of a base 
                period.
            (3) Reduction in payment for failure to report.--
                    (A) In general.--The amount payable under 
                this section to a qualified teaching health 
                center for a fiscal year shall be reduced by at 
                least 25 percent if the Secretary determines 
                that--
                            (i) the qualified teaching health 
                        center has failed to provide the 
                        Secretary, as an addendum to the 
                        qualified teaching health center's 
                        application under this section for such 
                        fiscal year, the report required under 
                        paragraph (1) for the previous fiscal 
                        year; or
                            (ii) such report fails to provide 
                        complete and accurate information 
                        required under any subparagraph of such 
                        paragraph.
                    (B) Notice and opportunity to provide 
                accurate and missing information.--Before 
                imposing a reduction under subparagraph (A) on 
                the basis of a qualified teaching health 
                center's failure to provide complete and 
                accurate information described in subparagraph 
                (A)(ii), the Secretary shall provide notice to 
                the teaching health center of such failure and 
                the Secretary's intention to impose such 
                reduction and shall provide the teaching health 
                center with the opportunity to provide the 
                required information within the period of 30 
                days beginning on the date of such notice. If 
                the teaching health center provides such 
                information within such period, no reduction 
                shall be made under subparagraph (A) on the 
                basis of the previous failure to provide such 
                information.
            (4) Residents.--The residents described in this 
        paragraph are those who are in part-time or full-time 
        equivalent resident training positions at a qualified 
        teaching health center in any approved graduate medical 
        residency training program.
    (i) Regulations.--The Secretary shall promulgate 
regulations to carry out this section.
    (j) Definitions.--In this section:
            (1) Approved graduate medical residency training 
        program.--The term ``approved graduate medical 
        residency training program'' means a residency or other 
        postgraduate medical training program--
                    (A) participation in which may be counted 
                toward certification in a specialty or 
                subspecialty and includes formal postgraduate 
                training programs in geriatric medicine 
                approved by the Secretary; and
                    (B) that meets criteria for accreditation 
                (as established by the Accreditation Council 
                for Graduate Medical Education, the American 
                Osteopathic Association, or the American Dental 
                Association).
            (2) Primary care residency program.--The term 
        ``primary care residency program'' has the meaning 
        given that term in section 749A.
            (3) Qualified teaching health center.--The term 
        ``qualified teaching health center'' has the meaning 
        given the term ``teaching health center'' in section 
        749A.

     Subpart XI--Community-Based Collaborative Care Network Program

SEC. 340H. [256I] COMMUNITY-BASED COLLABORATIVE CARE NETWORK PROGRAM. 
                    \1\
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    \1\ So in law. Sections 5508(c) and 10333 of Public Law 111-148 
added a subpart XI including adding two sections designated as section 
340H).
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    (a) In General.--The Secretary may award grants to eligible 
entities to support community-based collaborative care networks 
that meet the requirements of subsection (b).
    (b) Community-based Collaborative Care Networks.--
            (1) Description.--A community-based collaborative 
        care network (referred to in this section as a 
        ``network'') shall be a consortium of health care 
        providers with a joint governance structure (including 
        providers within a single entity) that provides 
        comprehensive coordinated and integrated health care 
        services (as defined by the Secretary) for low-income 
        populations.
            (2) Required inclusion.--A network shall include 
        the following providers (unless such provider does not 
        exist within the community, declines or refuses to 
        participate, or places unreasonable conditions on their 
        participation):
                    (A) A hospital that meets the criteria in 
                section 1923(b)(1) of the Social Security Act; 
                and
                    (B) All Federally qualified health centers 
                (as defined in section 1861(aa) of the Social 
                Security Act located in the community.
            (3) Priority.--In awarding grants, the Secretary 
        shall give priority to networks that include--
                    (A) the capability to provide the broadest 
                range of services to low-income individuals;
                    (B) the broadest range of providers that 
                currently serve a high volume of low-income 
                individuals; and
                    (C) a county or municipal department of 
                health.
    (c) Application.--
            (1) Application.--A network described in subsection 
        (b) shall submit an application to the Secretary.
            (2) Renewal.--In subsequent years, based on the 
        performance of grantees, the Secretary may provide 
        renewal grants to prior year grant recipients.
    (d) Use of Funds.--
            (1) Use by grantees.--Grant funds may be used for 
        the following activities:
                    (A) Assist low-income individuals to--
                            (i) access and appropriately use 
                        health services;
                            (ii) enroll in health coverage 
                        programs; and
                            (iii) obtain a regular primary care 
                        provider or a medical home.
                    (B) Provide case management and care 
                management.
                    (C) Perform health outreach using 
                neighborhood health workers or through other 
                means.
                    (D) Provide transportation.
                    (E) Expand capacity, including through 
                telehealth, after-hours services or urgent 
                care.
                    (F) Provide direct patient care services.
            (2) Grant funds to hrsa grantees.--The Secretary 
        may limit the percent of grant funding that may be 
        spent on direct care services provided by grantees of 
        programs administered by the Health Resources and 
        Services Administration or impose other requirements on 
        such grantees deemed necessary.
    (e) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section such sums as may 
be necessary for each of fiscal years 2011 through 2015.

          Part E--Narcotic Addicts and Other Drug Abusers \1\
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    \1\ The probable intent of the Congress is that part E be repealed. 
Section 3405(a) of Public Law 106-310 (114 Stat. 1221) provides as 
follows: ``Part E of title III (42 U.S.C. 257 et seq.) is repealed.'' 
No Act is identified as the subject of the amendment, but the citation 
given to the United States Code, section 257 of title 42, is the Code 
section that codifies section 341 of this Act (the first section in 
part E).
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                           care and treatment
    Sec. 341. [257] (a) The Surgeon General is authorized to 
provide for the confinement, care, protection, treatment, and 
discipline of persons addicted to the use of habit-forming 
narcotic drugs who are civilly committed to treatment under the 
Narcotic Addict Rehabilitation Act of 1966, addicts and other 
persons with drug abuse and drug dependence problems who 
voluntarily submit themselves for treatment, and addicts 
convicted of offenses against the United States, including 
persons convicted by general courts-martial and consular 
courts. Such care and treatment shall be provided at hospitals 
of the Service especially equipped for the accommodation of 
such patients or elsewhere where authorized under other 
provisions of law, and shall be designed to rehabilitate such 
persons, to restore them to health, and, where necessary, to 
train them to be self-supporting and self-reliant; but nothing 
in this section or in this part shall be construed to limit the 
authority of the Surgeon General under other provisions of law 
to provide for the conditional release of patients and for 
aftercare under supervision. In carrying out this subsection, 
the Secretary shall establish in each hospital and other 
appropriate medical facility of the Service a treatment and 
rehabilitation program for drug addicts and other persons with 
drug abuse and drug dependence problems who are in the area 
served by such hospital or other facility; except that the 
requirement of this sentence shall not apply in the case of any 
such hospital or other facility with respect to which the 
Secretary determines that there is not sufficient need for such 
a program in such hospital or other facility.
    (b) Upon the admittance to, and departure from, a hospital 
of the Service of a person who voluntarily submitted himself 
for treatment pursuant to the provisions of this section, and 
who at the time of his admittance to such hospital was a 
resident of the District of Columbia, the Surgeon General shall 
furnish to the Commissioners of the District of Columbia or 
their designated agent, the name, address, and such other 
pertinent information as may be useful in the rehabilitation to 
society of such person.
    (c) The Secretary may enter into agreements with the 
Secretary of Veterans Affairs, the Secretary of Defense, and 
the head of any other department or agency of the Government 
under which agreements hospitals and other appropriate medical 
facilities of the Service may be used in treatment and 
rehabilitation programs provided by such department or agency 
for drug addicts and other persons with drug abuse and other 
drug dependence problems who are in areas served by such 
hospitals or other facilities.
    employment of addicts or other persons with drug abuse and drug 
                          dependence problems
    Sec. 342. [258] Narcotic addicts or other persons with drug 
abuse and drug dependence problems in hospitals of the Service 
designated for their care shall be employed in such manner and 
under such conditions as the Surgeon General may direct. In 
such hospitals the Surgeon General may, in his discretion, 
establish industries, plants, factories, or shops for the 
production and manufacture of articles, commodities, and 
supplies for the United States Government. The Secretary of the 
Treasury may require any Government department, establishment, 
or other institution, for whom appropriations are made directly 
or indirectly by the Congress of the United States, to purchase 
at current market prices, as determined by him or his 
authorized representative, such of the articles, commodities, 
or supplies so produced or manufactured as meet their 
specifications; and the Surgeon General shall provide for 
payment to the inmates or their dependents of such pecuniary 
earnings as he may deem proper. The Secretary shall establish a 
working-capital fund for such industries, plants, factories, 
and shops out of any funds appropriated for Public Health 
Service hospitals at which addicts or other persons with drug 
abuse and drug dependence problems are treated and cared for; 
and such fund shall be available for the purchase, repair, or 
replacement of machinery or equipment, for the purchase of raw 
materials and supplies, for the purchase of uniforms and other 
distinctive wearing apparel of employees in the performance of 
their official duties, and for the employment of necessary 
civilian officers and employees. The Surgeon General may 
provide for the disposal of products of the industrial 
activities conducted pursuant to this section, and the proceeds 
of any sales thereof shall be covered into the Treasury of the 
United States to the credit of the working-capital fund.

                                convicts

    Sec. 343. [259] (a) The authority vested with the power to 
designate the place of confinement of a prisoner shall transfer 
to hospitals of the Service especially equipped for the 
accommodation of addicts or other persons with drug abuse and 
drug dependence problems, if accommodations are available, all 
addicts or other persons with drug abuse and drug dependence 
problems who have been or are hereafter sentenced to 
confinement, or who are now or shall hereafter be confined, in 
any penal, correctional, disciplinary, or reformatory 
institution of the United States, including those addicts or 
other persons with drug abuse and drug dependence problems 
convicted of offenses against the United States who are 
confined in State and Territorial prisons, penitentiaries, and 
reformatories, except that no addict or other person with a 
drug abuse or other drug dependence problem shall be 
transferred to a hospital of the Service who, in the opinion of 
the officer authorized to direct the transfer, is not a proper 
subject for confinement in such an institution either because 
of the nature of the crime he has committed or because of his 
apparent incorrigibility. The authority vested with the power 
to designate the place of confinement of a prisoner shall 
transfer from a hospital of the Service to the institution from 
which he was received, or to such other institution as may be 
designated by the proper authority, any addict or other person 
with a drug abuse or other drug dependence problem whose 
presence at a hospital of the Service is detrimental to the 
well-being of the hospital or who does not continue to be a 
narcotic addict or other person with a drug abuse or other drug 
dependence problem. All transfers of such prisoners to or from 
a hospital of the Service shall be accompanied by necessary 
attendants as directed by the officer in charge of such 
hospital and the actual and necessary expenses incident to such 
transfers shall be paid from the appropriation for the 
maintenance of such Service hospital except to the extent that 
other Federal agencies are authorized or required by law to pay 
expenses incident to such transfers. When sentence is 
pronounced against any person whom the prosecuting officer 
believes to be an addict or other person with a drug abuse or 
other drug dependence problem such officer shall report to the 
authority vested with the power to designate the place of 
confinement, the name of such person, the reasons for his 
belief, all pertinent facts bearing on such addiction, drug 
abuse, or drug dependence and the nature of the offense 
committed. Whenever an alien addict or other person with a drug 
abuse or other drug dependence problem transferred to a Service 
hospital pursuant to this subsection is entitled to his 
discharge but is subject to deportation, in lieu of being 
returned to the penal institution from which he came he shall 
be deported by the authority vested by law with power over 
deportation.
    (b) [Repealed.]
    (c) Not later than one month prior to the expiration of the 
sentence of any addict or other person with a drug abuse or 
other drug dependence problem confined in a Service hospital, 
he shall be examined by the Surgeon General or his authorized 
representative. If the Surgeon General believes the person to 
be discharged is still an addict or other person with a drug 
abuse or other drug dependence problem and that he may by 
further treatment in a Service hospital be cured of his 
addiction, drug abuse, or drug dependence the addict or other 
person with a drug abuse or other drug dependence problem shall 
be informed, in accordance with regulations, of the 
advisability of his submitting himself to further treatment. 
The addict or other person with a drug abuse or other drug 
dependence problem may then apply in writing to the Surgeon 
General for further treatment in a Service hospital for a 
period not exceeding the maximum length of time considered 
necessary by the Surgeon General. Upon approval of the 
application by the Surgeon General or his authorized agent, the 
addict or other person with a drug abuse or other drug 
dependence problem may be given such further treatment as is 
necessary to cure him of his addiction, drug abuse, or drug 
dependence.
    (d) Every person convicted of an offense against the United 
States, upon discharge, or upon release on parole or supervised 
release from a hospital of the Service, shall be furnished with 
the gratuities and transportation authorized by law to be 
furnished to prisoners upon release from a penal, correctional, 
disciplinary, or reformatory institution.
    (e) Any court of the United States having the power to 
suspend the imposition or execution of sentence and to place a 
defendant on probation under any existing laws may impose as 
one of the conditions of such probation that the defendant, if 
an addict, or other person with a drug abuse or other drug 
dependence problem shall submit himself for treatment at a 
hospital of the Service especially equipped for the 
accommodation of addicts or other persons with drug abuse and 
drug dependence problems until discharged therefrom as cured 
and that he shall be admitted thereto for such purpose. Upon 
the discharge of any such probationer from a hospital of the 
Service, he shall be furnished with the gratuities and 
transportation authorized by law to be furnished to prisoners 
upon release from a penal, correctional, disciplinary, or 
reformatory institution. The actual and necessary expense 
incident to transporting such probationer to such hospital and 
to furnishing such transportation and gratuities shall be paid 
from the appropriation for the maintenance of such hospital 
except to the extent that other Federal agencies are authorized 
or required by law to pay the cost of such transportation: 
Provided, That where existing law vests a discretion in any 
officer as to the place to which transportation shall be 
furnished or as to the amount of clothing and gratuities to be 
furnished, such discretion shall be exercised by the Surgeon 
General with respect to addicts or other persons with drug 
abuse and drug dependence problems discharged from hospitals of 
the Service.
                           voluntary patients
    Sec. 344. [260] (a) Any addict, or other person with a drug 
abuse or other drug dependence problem whether or not he shall 
have been convicted of an offense against the United States, 
may apply to the Surgeon General for admission to a hospital of 
the Service especially equipped for the accommodation of 
addicts or other persons with drug abuse and drug dependence 
problems.
    (b) Any applicant shall be examined by the Surgeon General 
who shall determine whether the applicant is an addict, or 
other person with a drug abuse or other drug dependence problem 
whether by treatment in a hospital of the Service he may 
probably be cured of his addiction, drug abuse, or drug 
dependence and the estimated length of time necessary to effect 
his cure. The Surgeon General may, in his discretion, admit the 
applicant to a Service hospital. No such addict or other person 
with drug abuse or other drug dependence problem shall be 
admitted unless he agrees to submit to treatment for the 
maximum amount of time estimated by the Surgeon General to be 
necessary to effect a cure, and unless suitable accommodations 
are available after all eligible addicts or other persons with 
drug abuse and drug dependence problems convicted of offenses 
against the United States have been admitted. Any such addict 
or other person with a drug abuse or other drug dependence 
problem may be required to pay for his subsistence, care, and 
treatment at rates fixed by the Surgeon General and amounts so 
paid shall be covered into the Treasury of the United States to 
the credit of the appropriation from which the expenditure for 
his subsistence, care, and treatment was made. Appropriations 
available for the care and treatment of addicts or other 
persons with drug abuse and drug dependence problems admitted 
to a hospital of the Service under this section shall be 
available, subject to regulations, for paying the cost of 
transportation to any place within the continental United 
States, including subsistence allowance while traveling, for 
any indigent addict or other person with a drug abuse or other 
drug dependence problem who is discharged as cured.
    (c) Any addict or other person with a drug abuse or other 
drug dependence problem admitted for treatment under this 
section, including any addict, or other person with a drug 
abuse or other drug dependence problem not convicted of an 
offense, who voluntarily submits himself for treatment, may be 
confined in a hospital of the Service for a period not 
exceeding the maximum amount of time estimated by the Surgeon 
General as necessary to effect a cure of the addiction, drug 
abuse, or drug dependence or until such time as he ceases to be 
an addict or other person with a drug abuse or other drug 
dependence problem.
    (d) Any addict or other person with a drug abuse or other 
drug dependence problem admitted for treatment under this 
section shall not thereby forfeit or abridge any of his rights 
as a citizen of the United States; nor shall such admission or 
treatment be used against him in any proceeding in any court; 
and the record of his voluntary commitment shall, except as 
otherwise provided by this Act, be confidential and shall not 
be divulged.
              persons committed from district of columbia
    Sec. 345. [260a] (a) The Surgeon General is authorized to 
admit for care and treatment in any hospital of the Service 
suitably equipped therefor, and thereafter to transfer between 
hospitals of the Service in accordance with section 321(b), any 
addict who is committed, under the provisions of the Act of 
June 24, 1953 (Public Law 76, Eighty-third Congress) \1\, to 
the Service or to a hospital thereof for care and treatment and 
who the Surgeon General determines is a proper subject for care 
and treatment. No such addict shall be admitted unless (1) 
committed prior to July 1, 1958; and (2) at the time of 
commitment, the number of persons in hospitals of the Service 
who have been admitted pursuant to this subsection is less than 
100; and (3) suitable accommodations are available after all 
eligible addicts convicted of offenses against the United 
States have been admitted.
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    \1\ 67 Stat. 77. Codified to section 24-601 et seq., D.C. Code.
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    (b) Any person admitted to a hospital of the Service 
pursuant to subsection (a) shall be discharged therefrom (1) 
upon order of the Superior Court of the District of Columbia, 
or (2) when he is found by the Surgeon General to be cured and 
rehabilitated. When any such person is so discharged, the 
Surgeon General shall give notice thereof to the Superior Court 
of the District of Columbia and shall deliver such person to 
such court for such further action as such court may deem 
necessary and proper under the provisions of the Act of June 
24, 1953 (Public Law 76, Eighty-third Congress). \1\
    (c) With respect to the detention, transfer, parole, or 
discharge of any person committed to a hospital of the Service 
in accordance with subsection (a), the Surgeon General and the 
officer in charge of the hospital, in addition to authority 
otherwise vested in them, shall have such authority as may be 
conferred upon them, respectively, by the order of the 
committing court.
    (d) The cost of providing care and treatment for persons 
admitted to a hospital of the Service pursuant to subsection 
(a) shall be a charge upon the District of Columbia and shall 
be paid by the District of Columbia to the Public Health 
Service, either in advance or otherwise, as may be determined 
by the Surgeon General. Such cost may be determined for each 
addict or on the basis of rates established for all or 
particular classes of patients, and shall include the cost of 
transportation to and from facilities of the Public Health 
Service. Moneys so paid to the Public Health Service shall be 
covered into the Treasury of the United States as miscellaneous 
receipts. Appropriations available for the care and treatment 
of addicts admitted to a hospital of the Service under this 
section shall be available, subject to regulations, for paying 
the cost of transportation to the District of Columbia, 
including subsistence allowance while traveling, for any such 
addict who is discharged.
                               penalties
    Sec. 346. [261] (a) Any person not authorized by law or by 
the Surgeon General who introduces or attempts to introduce 
into or upon the grounds of any hospital of the Service at 
which addicts or other persons with drug abuse and drug 
dependence problems are treated and cared for, any habit-
forming narcotic drug, or substance controlled under the 
Controlled Substances Act, weapon, or any other contraband 
article or thing, or any contraband letter or message intended 
to be received by an inmate thereof, shall be guilty of a 
felony and, upon conviction thereof, shall be punished by 
imprisonment for not more than ten years.
    (b) It shall be unlawful for any person properly committed 
thereto to escape or attempt to escape from a hospital of the 
Service at which addicts or other persons with drug abuse and 
drug dependence problems are treated and cared for, and any 
such person upon apprehension and conviction in a United States 
court shall be punished by imprisonment for not more than five 
years, such sentence to begin upon the expiration of the 
sentence for which such person was originally confined.
    (c) Any person who procures the escape of any person 
admitted to a hospital of the Service at which addicts or other 
persons with drug abuse and drug dependence problems are 
treated and cared for, or who advises, connives at, aids, or 
assists in such escape, or who conceals any such inmate after 
such escape, shall be punished upon conviction in a United 
States court by imprisonment in the penitentiary for not more 
than three years.
                          release of patients
    Sec. 347. [261a] For purposes of this Act, an individual 
shall be deemed cured of his addiction, drug abuse, or drug 
dependence, and rehabilitated if the Surgeon General determines 
that he has received the maximum benefits of treatment and care 
by the Service for his addiction, drug abuse, or drug 
dependence, or if the Surgeon General determines that his 
further treatment and care for such purpose would be 
detrimental to the interests of the Service.

  Part F--Licensing--Biological Products and Clinical Laboratories \1\
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    \1\ Section 511(d) of Public Law 104-132 (110 Stat. 1284) relates 
to the regulatory control of biological agents and includes a 
requirement that the Secretary ``establish and maintain a list of each 
biological agent that has the potential to pose a severe threat to 
public health and safety''.
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                     Subpart 1--Biological Products

                 regulation of biological products \2\
    Sec. 351. [262] (a)(1) No person shall introduce or deliver 
for introduction into interstate commerce any biological 
product unless--
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    \2\ Section 123(f) of Public Law 105-115 (111 Stat. 2324) provides 
as follows:
    ``(f) Special Rule.--The Secretary of Health and Human Services 
shall take measures to minimize differences in the review and approval 
of products required to have approved biologics license applications 
under section 351 of the Public Health Service Act (42 U.S.C. 262) and 
products required to have approved new drug applications under section 
505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(b)(1)).''.
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            (A) a biologics license under this subsection or 
        subsection (k) is in effect for the biological product; 
        and
            (B) each package of the biological product is 
        plainly marked with--
                    (i) the proper name of the biological 
                product contained in the package;
                    (ii) the name, address, and applicable 
                license number of the manufacturer of the 
                biological product; and
                    (iii) the expiration date of the biological 
                product.
    (2)(A) The Secretary shall establish, by regulation, 
requirements for the approval, suspension, and revocation of 
biologics licenses.
                    (B) Pediatric studies.--A person that 
                submits an application for a license under this 
                paragraph shall submit to the Secretary as part 
                of the application any assessments required 
                under section 505B of the Federal Food, Drug, 
                and Cosmetic Act.
    (C) The Secretary shall approve a biologics license 
application--
            (i) on the basis of a demonstration that--
                    (I) the biological product that is the 
                subject of the application is safe, pure, and 
                potent; and
                    (II) the facility in which the biological 
                product is manufactured, processed, packed, or 
                held meets standards designed to assure that 
                the biological product continues to be safe, 
                pure, and potent; and
            (ii) if the applicant (or other appropriate person) 
        consents to the inspection of the facility that is the 
        subject of the application, in accordance with 
        subsection (c).
    (D) Postmarket Studies and Clinical Trials; Labeling; Risk 
Evaluation and Mitigation Strategy.--A person that submits an 
application for a license under this paragraph is subject to 
sections 505(o), 505(p), and 505-1 of the Federal Food, Drug, 
and Cosmetic Act.
    (3) The Secretary shall prescribe requirements under which 
a biological product undergoing investigation shall be exempt 
from the requirements of paragraph (1).
    (b) No person shall falsely label or mark any package or 
container of any biological product or alter any label or mark 
on the package or container of the biological product so as to 
falsify the label or mark.
    (c) Any officer, agent, or employee of the Department of 
Health and Human Services, authorized by the Secretary for the 
purpose, may during all reasonable hours enter and inspect any 
establishment for the propagation or manufacture and 
preparation of any biological product.
      (d)(1) Upon a determination that a batch, lot, or other 
quantity of a product licensed under this section presents an 
imminent or substantial hazard to the public health, the 
Secretary shall issue an order immediately ordering the recall 
of such batch, lot, or other quantity of such product. An order 
under this paragraph shall be issued in accordance with section 
554 of title 5, United States Code.
      (2) Any violation of paragraph (1) shall subject the 
violator to a civil penalty of up to $100,000 per day of 
violation. The amount of a civil penalty under this paragraph 
shall, effective December 1 of each year beginning 1 year after 
the effective date of this paragraph, be increased by the 
percent change in the Consumer Price Index for the base quarter 
of such year over the Consumer Price Index for the base quarter 
of the preceding year, adjusted to the nearest \1/10\ of 1 
percent. For purposes of this paragraph, the term ``base 
quarter'', as used with respect to a year, means the calendar 
quarter ending on September 30 of such year and the price index 
for a base quarter is the arithmetical mean of such index for 
the 3 months comprising such quarter.
    (e) No person shall interfere with any officer, agent, or 
employee of the Service in the performance of any duty imposed 
upon him by this section or by regulations made by authority 
thereof.
    (f) Any person who shall violate, or aid or abet in 
violating, any of the provisions of this section shall be 
punished upon conviction by a fine not exceeding $500 or by 
imprisonment not exceeding one year, or by both such fine and 
imprisonment, in the discretion of the court.
    (g) Nothing contained in this Act shall be construed as in 
any way affecting, modifying, repealing, or superseding the 
provisions of the Federal Food, Drug, and Cosmetic Act (U.S.C., 
1940 edition, title 21, ch. 9). \1\
---------------------------------------------------------------------------
    \1\ Codification remains chapter 9 of title 21, United States Code 
(Sec. 301 et seq.).
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    (h) \2\ A partially processed biological product which--
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    \2\ Section 2102(d)(2) of title II of Public Law 104-134 (110 Stat. 
1321-319) amended certain provisions in subsection (h). Subsequently, 
section 2104 of such Public Law (110 Stat. 1321-320) amended subsection 
(h) in its entirety. The above reflects only the latter amendment.
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            (1) is not in a form applicable to the prevention, 
        treatment, or cure of diseases or injuries of man;
            (2) is not intended for sale in the United States; 
        and
            (3) is intended for further manufacture into final 
        dosage form outside the United States,
shall be subject to no restriction on the export of the product 
under this Act or the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321 et. seq.) if the product is manufactured, processed, 
packaged, and held in conformity with current good 
manufacturing practice requirements or meets international 
manufacturing standards as certified by an international 
standards organization recognized by the Secretary and meets 
the requirements of section 801(e)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381(e)).
    (i) In this section:
            (1) The term ``biological product'' means a virus, 
        therapeutic serum, toxin, antitoxin, vaccine, blood, 
        blood component or derivative, allergenic product, 
        protein (except any chemically synthesized 
        polypeptide), or analogous product, or arsphenamine or 
        derivative of arsphenamine (or any other trivalent 
        organic arsenic compound), applicable to the 
        prevention, treatment, or cure of a disease or 
        condition of human beings.
            (2) The term ``biosimilar'' or ``biosimilarity'', 
        in reference to a biological product that is the 
        subject of an application under subsection (k), means--
                    (A) that the biological product is highly 
                similar to the reference product 
                notwithstanding minor differences in clinically 
                inactive components; and
                    (B) there are no clinically meaningful 
                differences between the biological product and 
                the reference product in terms of the safety, 
                purity, and potency of the product.
            (3) The term ``interchangeable'' or 
        ``interchangeability'', in reference to a biological 
        product that is shown to meet the standards described 
        in subsection (k)(4), means that the biological product 
        may be substituted for the reference product without 
        the intervention of the health care provider who 
        prescribed the reference product.
            (4) The term ``reference product'' means the single 
        biological product licensed under subsection (a) 
        against which a biological product is evaluated in an 
        application submitted under subsection (k).
    (j) The Federal Food, Drug, and Cosmetic Act, including the 
requirements under sections 505(o), 505(p), and 505-1 of such 
Act, applies to a biological product subject to regulation 
under this section, except that a product for which a license 
has been approved under subsection (a) shall not be required to 
have an approved application under section 505 of such Act.
    (k) Licensure of Biological Products as Biosimilar or 
Interchangeable.--
            (1) In general.--Any person may submit an 
        application for licensure of a biological product under 
        this subsection.
            (2) Content.--
                    (A) In general.--
                            (i) Required information.--An 
                        application submitted under this 
                        subsection shall include information 
                        demonstrating that--
                                    (I) the biological product 
                                is biosimilar to a reference 
                                product based upon data derived 
                                from--
                                            (aa) analytical 
                                        studies that 
                                        demonstrate that the 
                                        biological product is 
                                        highly similar to the 
                                        reference product 
                                        notwithstanding minor 
                                        differences in 
                                        clinically inactive 
                                        components;
                                            (bb) animal studies 
                                        (including the 
                                        assessment of 
                                        toxicity); and
                                            (cc) a clinical 
                                        study or studies 
                                        (including the 
                                        assessment of 
                                        immunogenicity and 
                                        pharmacokinetics or 
                                        pharmacodynamics) that 
                                        are sufficient to 
                                        demonstrate safety, 
                                        purity, and potency in 
                                        1 or more appropriate 
                                        conditions of use for 
                                        which the reference 
                                        product is licensed and 
                                        intended to be used and 
                                        for which licensure is 
                                        sought for the 
                                        biological product;
                                    (II) the biological product 
                                and reference product utilize 
                                the same mechanism or 
                                mechanisms of action for the 
                                condition or conditions of use 
                                prescribed, recommended, or 
                                suggested in the proposed 
                                labeling, but only to the 
                                extent the mechanism or 
                                mechanisms of action are known 
                                for the reference product;
                                    (III) the condition or 
                                conditions of use prescribed, 
                                recommended, or suggested in 
                                the labeling proposed for the 
                                biological product have been 
                                previously approved for the 
                                reference product;
                                    (IV) the route of 
                                administration, the dosage 
                                form, and the strength of the 
                                biological product are the same 
                                as those of the reference 
                                product; and
                                    (V) the facility in which 
                                the biological product is 
                                manufactured, processed, 
                                packed, or held meets standards 
                                designed to assure that the 
                                biological product continues to 
                                be safe, pure, and potent.
                            (ii) Determination by secretary.--
                        The Secretary may determine, in the 
                        Secretary's discretion, that an element 
                        described in clause (i)(I) is 
                        unnecessary in an application submitted 
                        under this subsection.
                            (iii) Additional information.--An 
                        application submitted under this 
                        subsection--
                                    (I) shall include publicly-
                                available information regarding 
                                the Secretary's previous 
                                determination that the 
                                reference product is safe, 
                                pure, and potent; and
                                    (II) may include any 
                                additional information in 
                                support of the application, 
                                including publicly-available 
                                information with respect to the 
                                reference product or another 
                                biological product.
                    (B) Interchangeability.--An application (or 
                a supplement to an application) submitted under 
                this subsection may include information 
                demonstrating that the biological product meets 
                the standards described in paragraph (4).
            (3) Evaluation by secretary.--Upon review of an 
        application (or a supplement to an application) 
        submitted under this subsection, the Secretary shall 
        license the biological product under this subsection 
        if--
                    (A) the Secretary determines that the 
                information submitted in the application (or 
                the supplement) is sufficient to show that the 
                biological product--
                            (i) is biosimilar to the reference 
                        product; or
                            (ii) meets the standards described 
                        in paragraph (4), and therefore is 
                        interchangeable with the reference 
                        product; and
                    (B) the applicant (or other appropriate 
                person) consents to the inspection of the 
                facility that is the subject of the 
                application, in accordance with subsection (c).
            (4) Safety standards for determining 
        interchangeability.--Upon review of an application 
        submitted under this subsection or any supplement to 
        such application, the Secretary shall determine the 
        biological product to be interchangeable with the 
        reference product if the Secretary determines that the 
        information submitted in the application (or a 
        supplement to such application) is sufficient to show 
        that--
                    (A) the biological product--
                            (i) is biosimilar to the reference 
                        product; and
                            (ii) can be expected to produce the 
                        same clinical result as the reference 
                        product in any given patient; and
                    (B) for a biological product that is 
                administered more than once to an individual, 
                the risk in terms of safety or diminished 
                efficacy of alternating or switching between 
                use of the biological product and the reference 
                product is not greater than the risk of using 
                the reference product without such alternation 
                or switch.
            (5) General rules.--
                    (A) One reference product per 
                application.--A biological product, in an 
                application submitted under this subsection, 
                may not be evaluated against more than 1 
                reference product.
                    (B) Review.--An application submitted under 
                this subsection shall be reviewed by the 
                division within the Food and Drug 
                Administration that is responsible for the 
                review and approval of the application under 
                which the reference product is licensed.
                    (C) Risk evaluation and mitigation 
                strategies.--The authority of the Secretary 
                with respect to risk evaluation and mitigation 
                strategies under the Federal Food, Drug, and 
                Cosmetic Act shall apply to biological products 
                licensed under this subsection in the same 
                manner as such authority applies to biological 
                products licensed under subsection (a).
            (6) Exclusivity for first interchangeable 
        biological product.--Upon review of an application 
        submitted under this subsection relying on the same 
        reference product for which a prior biological product 
        has received a determination of interchangeability for 
        any condition of use, the Secretary shall not make a 
        determination under paragraph (4) that the second or 
        subsequent biological product is interchangeable for 
        any condition of use until the earlier of--
                    (A) 1 year after the first commercial 
                marketing of the first interchangeable 
                biosimilar biological product to be approved as 
                interchangeable for that reference product;
                    (B) 18 months after--
                            (i) a final court decision on all 
                        patents in suit in an action instituted 
                        under subsection (l)(6) against the 
                        applicant that submitted the 
                        application for the first approved 
                        interchangeable biosimilar biological 
                        product; or
                            (ii) the dismissal with or without 
                        prejudice of an action instituted under 
                        subsection (l)(6) against the applicant 
                        that submitted the application for the 
                        first approved interchangeable 
                        biosimilar biological product; or
                    (C)(i) 42 months after approval of the 
                first interchangeable biosimilar biological 
                product if the applicant that submitted such 
                application has been sued under subsection 
                (l)(6) and such litigation is still ongoing 
                within such 42-month period; or
                    (ii) 18 months after approval of the first 
                interchangeable biosimilar biological product 
                if the applicant that submitted such 
                application has not been sued under subsection 
                (l)(6).
        For purposes of this paragraph, the term ``final court 
        decision'' means a final decision of a court from which 
        no appeal (other than a petition to the United States 
        Supreme Court for a writ of certiorari) has been or can 
        be taken.
            (7) Exclusivity for reference product.--
                    (A) Effective date of biosimilar 
                application approval.--Approval of an 
                application under this subsection may not be 
                made effective by the Secretary until the date 
                that is 12 years after the date on which the 
                reference product was first licensed under 
                subsection (a).
                    (B) Filing period.--An application under 
                this subsection may not be submitted to the 
                Secretary until the date that is 4 years after 
                the date on which the reference product was 
                first licensed under subsection (a).
                    (C) First licensure.--Subparagraphs (A) and 
                (B) shall not apply to a license for or 
                approval of--
                            (i) a supplement for the biological 
                        product that is the reference product; 
                        or
                            (ii) a subsequent application filed 
                        by the same sponsor or manufacturer of 
                        the biological product that is the 
                        reference product (or a licensor, 
                        predecessor in interest, or other 
                        related entity) for--
                                    (I) a change (not including 
                                a modification to the structure 
                                of the biological product) that 
                                results in a new indication, 
                                route of administration, dosing 
                                schedule, dosage form, delivery 
                                system, delivery device, or 
                                strength; or
                                    (II) a modification to the 
                                structure of the biological 
                                product that does not result in 
                                a change in safety, purity, or 
                                potency.
            (8) Guidance documents.--
                    (A) In general.--The Secretary may, after 
                opportunity for public comment, issue guidance 
                in accordance, except as provided in 
                subparagraph (B)(i), with section 701(h) of the 
                Federal Food, Drug, and Cosmetic Act with 
                respect to the licensure of a biological 
                product under this subsection. Any such 
                guidance may be general or specific.
                    (B) Public comment.--
                            (i) In general.--The Secretary 
                        shall provide the public an opportunity 
                        to comment on any proposed guidance 
                        issued under subparagraph (A) before 
                        issuing final guidance.
                            (ii) Input regarding most valuable 
                        guidance.--The Secretary shall 
                        establish a process through which the 
                        public may provide the Secretary with 
                        input regarding priorities for issuing 
                        guidance.
                    (C) No requirement for application 
                consideration.--The issuance (or non-issuance) 
                of guidance under subparagraph (A) shall not 
                preclude the review of, or action on, an 
                application submitted under this subsection.
                    (D) Requirement for product class-specific 
                guidance.--If the Secretary issues product 
                class-specific guidance under subparagraph (A), 
                such guidance shall include a description of--
                            (i) the criteria that the Secretary 
                        will use to determine whether a 
                        biological product is highly similar to 
                        a reference product in such product 
                        class; and
                            (ii) the criteria, if available, 
                        that the Secretary will use to 
                        determine whether a biological product 
                        meets the standards described in 
                        paragraph (4).
                    (E) Certain product classes.--
                            (i) Guidance.--The Secretary may 
                        indicate in a guidance document that 
                        the science and experience, as of the 
                        date of such guidance, with respect to 
                        a product or product class (not 
                        including any recombinant protein) does 
                        not allow approval of an application 
                        for a license as provided under this 
                        subsection for such product or product 
                        class.
                            (ii) Modification or reversal.--The 
                        Secretary may issue a subsequent 
                        guidance document under subparagraph 
                        (A) to modify or reverse a guidance 
                        document under clause (i).
                            (iii) No effect on ability to deny 
                        license.--Clause (i) shall not be 
                        construed to require the Secretary to 
                        approve a product with respect to which 
                        the Secretary has not indicated in a 
                        guidance document that the science and 
                        experience, as described in clause (i), 
                        does not allow approval of such an 
                        application.
    (l) Patents.--
            (1) Confidential access to subsection (k) 
        application.--
                    (A) Application of paragraph.--Unless 
                otherwise agreed to by a person that submits an 
                application under subsection (k) (referred to 
                in this subsection as the ``subsection (k) 
                applicant'') and the sponsor of the application 
                for the reference product (referred to in this 
                subsection as the ``reference product 
                sponsor''), the provisions of this paragraph 
                shall apply to the exchange of information 
                described in this subsection.
                    (B) In general.--
                            (i) Provision of confidential 
                        information.--When a subsection (k) 
                        applicant submits an application under 
                        subsection (k), such applicant shall 
                        provide to the persons described in 
                        clause (ii), subject to the terms of 
                        this paragraph, confidential access to 
                        the information required to be produced 
                        pursuant to paragraph (2) and any other 
                        information that the subsection (k) 
                        applicant determines, in its sole 
                        discretion, to be appropriate (referred 
                        to in this subsection as the 
                        ``confidential information'').
                            (ii) Recipients of information.--
                        The persons described in this clause 
                        are the following:
                                    (I) Outside counsel.--One 
                                or more attorneys designated by 
                                the reference product sponsor 
                                who are employees of an entity 
                                other than the reference 
                                product sponsor (referred to in 
                                this paragraph as the ``outside 
                                counsel''), provided that such 
                                attorneys do not engage, 
                                formally or informally, in 
                                patent prosecution relevant or 
                                related to the reference 
                                product.
                                    (II) In-house counsel.--One 
                                attorney that represents the 
                                reference product sponsor who 
                                is an employee of the reference 
                                product sponsor, provided that 
                                such attorney does not engage, 
                                formally or informally, in 
                                patent prosecution relevant or 
                                related to the reference 
                                product.
                            (iii) Patent owner access.--A 
                        representative of the owner of a patent 
                        exclusively licensed to a reference 
                        product sponsor with respect to the 
                        reference product and who has retained 
                        a right to assert the patent or 
                        participate in litigation concerning 
                        the patent may be provided the 
                        confidential information, provided that 
                        the representative informs the 
                        reference product sponsor and the 
                        subsection (k) applicant of his or her 
                        agreement to be subject to the 
                        confidentiality provisions set forth in 
                        this paragraph, including those under 
                        clause (ii).
                    (C) Limitation on disclosure.--No person 
                that receives confidential information pursuant 
                to subparagraph (B) shall disclose any 
                confidential information to any other person or 
                entity, including the reference product sponsor 
                employees, outside scientific consultants, or 
                other outside counsel retained by the reference 
                product sponsor, without the prior written 
                consent of the subsection (k) applicant, which 
                shall not be unreasonably withheld.
                    (D) Use of confidential information.--
                Confidential information shall be used for the 
                sole and exclusive purpose of determining, with 
                respect to each patent assigned to or 
                exclusively licensed by the reference product 
                sponsor, whether a claim of patent infringement 
                could reasonably be asserted if the subsection 
                (k) applicant engaged in the manufacture, use, 
                offering for sale, sale, or importation into 
                the United States of the biological product 
                that is the subject of the application under 
                subsection (k).
                    (E) Ownership of confidential 
                information.--The confidential information 
                disclosed under this paragraph is, and shall 
                remain, the property of the subsection (k) 
                applicant. By providing the confidential 
                information pursuant to this paragraph, the 
                subsection (k) applicant does not provide the 
                reference product sponsor or the outside 
                counsel any interest in or license to use the 
                confidential information, for purposes other 
                than those specified in subparagraph (D).
                    (F) Effect of infringement action.--In the 
                event that the reference product sponsor files 
                a patent infringement suit, the use of 
                confidential information shall continue to be 
                governed by the terms of this paragraph until 
                such time as a court enters a protective order 
                regarding the information. Upon entry of such 
                order, the subsection (k) applicant may 
                redesignate confidential information in 
                accordance with the terms of that order. No 
                confidential information shall be included in 
                any publicly-available complaint or other 
                pleading. In the event that the reference 
                product sponsor does not file an infringement 
                action by the date specified in paragraph (6), 
                the reference product sponsor shall return or 
                destroy all confidential information received 
                under this paragraph, provided that if the 
                reference product sponsor opts to destroy such 
                information, it will confirm destruction in 
                writing to the subsection (k) applicant.
                    (G) Rule of construction.--Nothing in this 
                paragraph shall be construed--
                            (i) as an admission by the 
                        subsection (k) applicant regarding the 
                        validity, enforceability, or 
                        infringement of any patent; or
                            (ii) as an agreement or admission 
                        by the subsection (k) applicant with 
                        respect to the competency, relevance, 
                        or materiality of any confidential 
                        information.
                    (H) Effect of violation.--The disclosure of 
                any confidential information in violation of 
                this paragraph shall be deemed to cause the 
                subsection (k) applicant to suffer irreparable 
                harm for which there is no adequate legal 
                remedy and the court shall consider immediate 
                injunctive relief to be an appropriate and 
                necessary remedy for any violation or 
                threatened violation of this paragraph.
            (2) Subsection (k) application information.--Not 
        later than 20 days after the Secretary notifies the 
        subsection (k) applicant that the application has been 
        accepted for review, the subsection (k) applicant--
                    (A) shall provide to the reference product 
                sponsor a copy of the application submitted to 
                the Secretary under subsection (k), and such 
                other information that describes the process or 
                processes used to manufacture the biological 
                product that is the subject of such 
                application; and
                    (B) may provide to the reference product 
                sponsor additional information requested by or 
                on behalf of the reference product sponsor.
            (3) List and description of patents.--
                    (A) List by reference product sponsor.--Not 
                later than 60 days after the receipt of the 
                application and information under paragraph 
                (2), the reference product sponsor shall 
                provide to the subsection (k) applicant--
                            (i) a list of patents for which the 
                        reference product sponsor believes a 
                        claim of patent infringement could 
                        reasonably be asserted by the reference 
                        product sponsor, or by a patent owner 
                        that has granted an exclusive license 
                        to the reference product sponsor with 
                        respect to the reference product, if a 
                        person not licensed by the reference 
                        product sponsor engaged in the making, 
                        using, offering to sell, selling, or 
                        importing into the United States of the 
                        biological product that is the subject 
                        of the subsection (k) application; and
                            (ii) an identification of the 
                        patents on such list that the reference 
                        product sponsor would be prepared to 
                        license to the subsection (k) 
                        applicant.
                    (B) List and description by subsection (k) 
                applicant.--Not later than 60 days after 
                receipt of the list under subparagraph (A), the 
                subsection (k) applicant--
                            (i) may provide to the reference 
                        product sponsor a list of patents to 
                        which the subsection (k) applicant 
                        believes a claim of patent infringement 
                        could reasonably be asserted by the 
                        reference product sponsor if a person 
                        not licensed by the reference product 
                        sponsor engaged in the making, using, 
                        offering to sell, selling, or importing 
                        into the United States of the 
                        biological product that is the subject 
                        of the subsection (k) application;
                            (ii) shall provide to the reference 
                        product sponsor, with respect to each 
                        patent listed by the reference product 
                        sponsor under subparagraph (A) or 
                        listed by the subsection (k) applicant 
                        under clause (i)--
                                    (I) a detailed statement 
                                that describes, on a claim by 
                                claim basis, the factual and 
                                legal basis of the opinion of 
                                the subsection (k) applicant 
                                that such patent is invalid, 
                                unenforceable, or will not be 
                                infringed by the commercial 
                                marketing of the biological 
                                product that is the subject of 
                                the subsection (k) application; 
                                or
                                    (II) a statement that the 
                                subsection (k) applicant does 
                                not intend to begin commercial 
                                marketing of the biological 
                                product before the date that 
                                such patent expires; and
                            (iii) shall provide to the 
                        reference product sponsor a response 
                        regarding each patent identified by the 
                        reference product sponsor under 
                        subparagraph (A)(ii).
                    (C) Description by reference product 
                sponsor.--Not later than 60 days after receipt 
                of the list and statement under subparagraph 
                (B), the reference product sponsor shall 
                provide to the subsection (k) applicant a 
                detailed statement that describes, with respect 
                to each patent described in subparagraph 
                (B)(ii)(I), on a claim by claim basis, the 
                factual and legal basis of the opinion of the 
                reference product sponsor that such patent will 
                be infringed by the commercial marketing of the 
                biological product that is the subject of the 
                subsection (k) application and a response to 
                the statement concerning validity and 
                enforceability provided under subparagraph 
                (B)(ii)(I).
            (4) Patent resolution negotiations.--
                    (A) In general.--After receipt by the 
                subsection (k) applicant of the statement under 
                paragraph (3)(C), the reference product sponsor 
                and the subsection (k) applicant shall engage 
                in good faith negotiations to agree on which, 
                if any, patents listed under paragraph (3) by 
                the subsection (k) applicant or the reference 
                product sponsor shall be the subject of an 
                action for patent infringement under paragraph 
                (6).
                    (B) Failure to reach agreement.--If, within 
                15 days of beginning negotiations under 
                subparagraph (A), the subsection (k) applicant 
                and the reference product sponsor fail to agree 
                on a final and complete list of which, if any, 
                patents listed under paragraph (3) by the 
                subsection (k) applicant or the reference 
                product sponsor shall be the subject of an 
                action for patent infringement under paragraph 
                (6), the provisions of paragraph (5) shall 
                apply to the parties.
            (5) Patent resolution if no agreement.--
                    (A) Number of patents.--The subsection (k) 
                applicant shall notify the reference product 
                sponsor of the number of patents that such 
                applicant will provide to the reference product 
                sponsor under subparagraph (B)(i)(I).
                    (B) Exchange of patent lists.--
                            (i) In general.--On a date agreed 
                        to by the subsection (k) applicant and 
                        the reference product sponsor, but in 
                        no case later than 5 days after the 
                        subsection (k) applicant notifies the 
                        reference product sponsor under 
                        subparagraph (A), the subsection (k) 
                        applicant and the reference product 
                        sponsor shall simultaneously exchange--
                                    (I) the list of patents 
                                that the subsection (k) 
                                applicant believes should be 
                                the subject of an action for 
                                patent infringement under 
                                paragraph (6); and
                                    (II) the list of patents, 
                                in accordance with clause (ii), 
                                that the reference product 
                                sponsor believes should be the 
                                subject of an action for patent 
                                infringement under paragraph 
                                (6).
                            (ii) Number of patents listed by 
                        reference product sponsor.--
                                    (I) In general.--Subject to 
                                subclause (II), the number of 
                                patents listed by the reference 
                                product sponsor under clause 
                                (i)(II) may not exceed the 
                                number of patents listed by the 
                                subsection (k) applicant under 
                                clause (i)(I).
                                    (II) Exception.--If a 
                                subsection (k) applicant does 
                                not list any patent under 
                                clause (i)(I), the reference 
                                product sponsor may list 1 
                                patent under clause (i)(II).
            (6) Immediate patent infringement action.--
                    (A) Action if agreement on patent list.--If 
                the subsection (k) applicant and the reference 
                product sponsor agree on patents as described 
                in paragraph (4), not later than 30 days after 
                such agreement, the reference product sponsor 
                shall bring an action for patent infringement 
                with respect to each such patent.
                    (B) Action if no agreement on patent 
                list.--If the provisions of paragraph (5) apply 
                to the parties as described in paragraph 
                (4)(B), not later than 30 days after the 
                exchange of lists under paragraph (5)(B), the 
                reference product sponsor shall bring an action 
                for patent infringement with respect to each 
                patent that is included on such lists.
                    (C) Notification and publication of 
                complaint.--
                            (i) Notification to secretary.--Not 
                        later than 30 days after a complaint is 
                        served to a subsection (k) applicant in 
                        an action for patent infringement 
                        described under this paragraph, the 
                        subsection (k) applicant shall provide 
                        the Secretary with notice and a copy of 
                        such complaint.
                            (ii) Publication by secretary.--The 
                        Secretary shall publish in the Federal 
                        Register notice of a complaint received 
                        under clause (i).
            (7) Newly issued or licensed patents.--In the case 
        of a patent that--
                    (A) is issued to, or exclusively licensed 
                by, the reference product sponsor after the 
                date that the reference product sponsor 
                provided the list to the subsection (k) 
                applicant under paragraph (3)(A); and
                    (B) the reference product sponsor 
                reasonably believes that, due to the issuance 
                of such patent, a claim of patent infringement 
                could reasonably be asserted by the reference 
                product sponsor if a person not licensed by the 
                reference product sponsor engaged in the 
                making, using, offering to sell, selling, or 
                importing into the United States of the 
                biological product that is the subject of the 
                subsection (k) application,
        not later than 30 days after such issuance or 
        licensing, the reference product sponsor shall provide 
        to the subsection (k) applicant a supplement to the 
        list provided by the reference product sponsor under 
        paragraph (3)(A) that includes such patent, not later 
        than 30 days after such supplement is provided, the 
        subsection (k) applicant shall provide a statement to 
        the reference product sponsor in accordance with 
        paragraph (3)(B), and such patent shall be subject to 
        paragraph (8).
            (8) Notice of commercial marketing and preliminary 
        injunction.--
                    (A) Notice of commercial marketing.--The 
                subsection (k) applicant shall provide notice 
                to the reference product sponsor not later than 
                180 days before the date of the first 
                commercial marketing of the biological product 
                licensed under subsection (k).
                    (B) Preliminary injunction.--After 
                receiving the notice under subparagraph (A) and 
                before such date of the first commercial 
                marketing of such biological product, the 
                reference product sponsor may seek a 
                preliminary injunction prohibiting the 
                subsection (k) applicant from engaging in the 
                commercial manufacture or sale of such 
                biological product until the court decides the 
                issue of patent validity, enforcement, and 
                infringement with respect to any patent that 
                is--
                            (i) included in the list provided 
                        by the reference product sponsor under 
                        paragraph (3)(A) or in the list 
                        provided by the subsection (k) 
                        applicant under paragraph (3)(B); and
                            (ii) not included, as applicable, 
                        on--
                                    (I) the list of patents 
                                described in paragraph (4); or
                                    (II) the lists of patents 
                                described in paragraph (5)(B).
                    (C) Reasonable cooperation.--If the 
                reference product sponsor has sought a 
                preliminary injunction under subparagraph (B), 
                the reference product sponsor and the 
                subsection (k) applicant shall reasonably 
                cooperate to expedite such further discovery as 
                is needed in connection with the preliminary 
                injunction motion.
            (9) Limitation on declaratory judgment action.--
                    (A) Subsection (k) application provided.--
                If a subsection (k) applicant provides the 
                application and information required under 
                paragraph (2)(A), neither the reference product 
                sponsor nor the subsection (k) applicant may, 
                prior to the date notice is received under 
                paragraph (8)(A), bring any action under 
                section 2201 of title 28, United States Code, 
                for a declaration of infringement, validity, or 
                enforceability of any patent that is described 
                in clauses (i) and (ii) of paragraph (8)(B).
                    (B) Subsequent failure to act by subsection 
                (k) applicant.--If a subsection (k) applicant 
                fails to complete an action required of the 
                subsection (k) applicant under paragraph 
                (3)(B)(ii), paragraph (5), paragraph (6)(C)(i), 
                paragraph (7), or paragraph (8)(A), the 
                reference product sponsor, but not the 
                subsection (k) applicant, may bring an action 
                under section 2201 of title 28, United States 
                Code, for a declaration of infringement, 
                validity, or enforceability of any patent 
                included in the list described in paragraph 
                (3)(A), including as provided under paragraph 
                (7).
                    (C) Subsection (k) application not 
                provided.--If a subsection (k) applicant fails 
                to provide the application and information 
                required under paragraph (2)(A), the reference 
                product sponsor, but not the subsection (k) 
                applicant, may bring an action under section 
                2201 of title 28, United States Code, for a 
                declaration of infringement, validity, or 
                enforceability of any patent that claims the 
                biological product or a use of the biological 
                product.
    (m) Pediatric Studies.--
            (1) Application of certain provisions.--The 
        provisions of subsections (a), (d), (e), (f), (i), (j), 
        (k), (l), (p), and (q) of section 505A of the Federal 
        Food, Drug, and Cosmetic Act shall apply with respect 
        to the extension of a period under paragraphs (2) and 
        (3) to the same extent and in the same manner as such 
        provisions apply with respect to the extension of a 
        period under subsection (b) or (c) of section 505A of 
        the Federal Food, Drug, and Cosmetic Act.
            (2) Market exclusivity for new biological 
        products.--If, prior to approval of an application that 
        is submitted under subsection (a), the Secretary 
        determines that information relating to the use of a 
        new biological product in the pediatric population may 
        produce health benefits in that population, the 
        Secretary makes a written request for pediatric studies 
        (which shall include a timeframe for completing such 
        studies), the applicant agrees to the request, such 
        studies are completed using appropriate formulations 
        for each age group for which the study is requested 
        within any such timeframe, and the reports thereof are 
        submitted and accepted in accordance with section 
        505A(d)(3) of the Federal Food, Drug, and Cosmetic 
        Act--
                    (A) the periods for such biological product 
                referred to in subsection (k)(7) are deemed to 
                be 4 years and 6 months rather than 4 years and 
                12 years and 6 months rather than 12 years; and
                    (B) if the biological product is designated 
                under section 526 for a rare disease or 
                condition, the period for such biological 
                product referred to in section 527(a) is deemed 
                to be 7 years and 6 months rather than 7 years.
            (3) Market exclusivity for already-marketed 
        biological products.--If the Secretary determines that 
        information relating to the use of a licensed 
        biological product in the pediatric population may 
        produce health benefits in that population and makes a 
        written request to the holder of an approved 
        application under subsection (a) for pediatric studies 
        (which shall include a timeframe for completing such 
        studies), the holder agrees to the request, such 
        studies are completed using appropriate formulations 
        for each age group for which the study is requested 
        within any such timeframe, and the reports thereof are 
        submitted and accepted in accordance with section 
        505A(d)(3) of the Federal Food, Drug, and Cosmetic 
        Act--
                    (A) the periods for such biological product 
                referred to in subsection (k)(7) are deemed to 
                be 4 years and 6 months rather than 4 years and 
                12 years and 6 months rather than 12 years; and
                    (B) if the biological product is designated 
                under section 526 for a rare disease or 
                condition, the period for such biological 
                product referred to in section 527(a) is deemed 
                to be 7 years and 6 months rather than 7 years.
            (4) Exception.--The Secretary shall not extend a 
        period referred to in paragraph (2)(A), (2)(B), (3)(A), 
        or (3)(B) if the determination under section 505A(d)(3) 
        is made later than 9 months prior to the expiration of 
        such period.

SEC. 351A. [262A] ENHANCED CONTROL OF DANGEROUS BIOLOGICAL AGENTS AND 
                    TOXINS. \3\
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    \3\ A program is carried out by the Secretary of Agriculture with 
respect to each biological agent and each toxin that the Secretary 
determines has the potential to pose a severe threat to animal or plant 
health, or to animal or plant products. Such program has requirements 
and authorities similar to those established in section 351A above. See 
subtitle B of title II of Public Law 107-188 (section 211 et seq.; 116 
Stat. 647). Subtitle C of such title (section 221 et seq.; 116 Stat. 
657) relates to interagency coordination of the two programs.
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    (a) Regulatory Control of Certain Biological Agents and 
Toxins.--
            (1) List of biological agents and toxins.--
                    (A) In general.--The Secretary shall by 
                regulation establish and maintain a list of 
                each biological agent and each toxin that has 
                the potential to pose a severe threat to public 
                health and safety.
                    (B) Criteria.--In determining whether to 
                include an agent or toxin on the list under 
                subparagraph (A), the Secretary shall--
                            (i) consider--
                                    (I) the effect on human 
                                health of exposure to the agent 
                                or toxin;
                                    (II) the degree of 
                                contagiousness of the agent or 
                                toxin and the methods by which 
                                the agent or toxin is 
                                transferred to humans;
                                    (III) the availability and 
                                effectiveness of 
                                pharmacotherapies and 
                                immunizations to treat and 
                                prevent any illness resulting 
                                from infection by the agent or 
                                toxin; and
                                    (IV) any other criteria, 
                                including the needs of children 
                                and other vulnerable 
                                populations, that the Secretary 
                                considers appropriate; and
                            (ii) consult with appropriate 
                        Federal departments and agencies and 
                        with scientific experts representing 
                        appropriate professional groups, 
                        including groups with pediatric 
                        expertise.
            (2) Biennial review.--The Secretary shall review 
        and republish the list under paragraph (1) biennially, 
        or more often as needed, and shall by regulation revise 
        the list as necessary in accordance with such 
        paragraph.
    (b) Regulation of Transfers of Listed Agents and Toxins.--
The Secretary shall by regulation provide for--
            (1) the establishment and enforcement of safety 
        procedures for the transfer of listed agents and 
        toxins, including measures to ensure--
                    (A) proper training and appropriate skills 
                to handle such agents and toxins; and
                    (B) proper laboratory facilities to contain 
                and dispose of such agents and toxins;
            (2) the establishment and enforcement of safeguard 
        and security measures to prevent access to such agents 
        and toxins for use in domestic or international 
        terrorism or for any other criminal purpose;
            (3) the establishment of procedures to protect the 
        public safety in the event of a transfer or potential 
        transfer of such an agent or toxin in violation of the 
        safety procedures established under paragraph (1) or 
        the safeguard and security measures established under 
        paragraph (2); and
            (4) appropriate availability of biological agents 
        and toxins for research, education, and other 
        legitimate purposes.
    (c) Possession and Use of Listed Agents and Toxins.--The 
Secretary shall by regulation provide for the establishment and 
enforcement of standards and procedures governing the 
possession and use of listed agents and toxins, including the 
provisions described in paragraphs (1) through (4) of 
subsection (b), in order to protect the public health and 
safety.
    (d) Registration; Identification; Database.--
            (1) Registration.--Regulations under subsections 
        (b) and (c) shall require registration with the 
        Secretary of the possession, use, and transfer of 
        listed agents and toxins, and shall include provisions 
        to ensure that persons seeking to register under such 
        regulations have a lawful purpose to possess, use, or 
        transfer such agents and toxins, including provisions 
        in accordance with subsection (e)(6).
            (2) Identification; database.--Regulations under 
        subsections (b) and (c) shall require that registration 
        include (if available to the person registering) 
        information regarding the characterization of listed 
        agents and toxins to facilitate their identification, 
        including their source. The Secretary shall maintain a 
        national database that includes the names and locations 
        of registered persons, the listed agents and toxins 
        such persons are possessing, using, or transferring, 
        and information regarding the characterization of such 
        agents and toxins.
    (e) Safeguard and Security Requirements for Registered 
Persons.--
            (1) In general.--Regulations under subsections (b) 
        and (c) shall include appropriate safeguard and 
        security requirements for persons possessing, using, or 
        transferring a listed agent or toxin commensurate with 
        the risk such agent or toxin poses to public health and 
        safety (including the risk of use in domestic or 
        international terrorism). The Secretary shall establish 
        such requirements in collaboration with the Secretary 
        of Homeland Security and the Attorney General, and 
        shall ensure compliance with such requirements as part 
        of the registration system under such regulations.
            (2) Limiting access to listed agents and toxins.--
        Requirements under paragraph (1) shall include 
        provisions to ensure that registered persons--
                    (A) provide access to listed agents and 
                toxins to only those individuals whom the 
                registered person involved determines have a 
                legitimate need to handle or use such agents 
                and toxins;
                    (B) submit the names and other identifying 
                information for such individuals to the 
                Secretary and the Attorney General, promptly 
                after first determining that the individuals 
                need access under subparagraph (A), and 
                periodically thereafter while the individuals 
                have such access, not less frequently than once 
                every five years;
                    (C) deny access to such agents and toxins 
                by individuals whom the Attorney General has 
                identified as restricted persons; and
                    (D) limit or deny access to such agents and 
                toxins by individuals whom the Attorney General 
                has identified as within any category under 
                paragraph (3)(B)(ii), if limiting or denying 
                such access by the individuals involved is 
                determined appropriate by the Secretary, in 
                consultation with the Attorney General.
            (3) Submitted names; use of databases by attorney 
        general.--
                    (A) In general.--Upon the receipt of names 
                and other identifying information under 
                paragraph (2)(B), the Attorney General shall, 
                for the sole purpose of identifying whether the 
                individuals involved are within any of the 
                categories specified in subparagraph (B), 
                promptly use criminal, immigration, national 
                security, and other electronic databases that 
                are available to the Federal Government and are 
                appropriate for such purpose.
                    (B) Certain individuals.--For purposes of 
                subparagraph (A), the categories specified in 
                this subparagraph regarding an individual are 
                that--
                            (i) the individual is a restricted 
                        person; or
                            (ii) the individual is reasonably 
                        suspected by any Federal law 
                        enforcement or intelligence agency of--
                                    (I) committing a crime set 
                                forth in section 2332b(g)(5) of 
                                title 18, United States Code;
                                    (II) knowing involvement 
                                with an organization that 
                                engages in domestic or 
                                international terrorism (as 
                                defined in section 2331 of such 
                                title 18) or with any other 
                                organization that engages in 
                                intentional crimes of violence; 
                                or
                                    (III) being an agent of a 
                                foreign power (as defined in 
                                section 1801 of title 50, 
                                United States Code).
                    (C) Notification by attorney general 
                regarding submitted names.--After the receipt 
                of a name and other identifying information 
                under paragraph (2)(B), the Attorney General 
                shall promptly notify the Secretary whether the 
                individual is within any of the categories 
                specified in subparagraph (B).
            (4) Notifications by secretary.--The Secretary, 
        after receiving notice under paragraph (3) regarding an 
        individual, shall promptly notify the registered person 
        involved of whether the individual is granted or denied 
        access under paragraph (2). If the individual is denied 
        such access, the Secretary shall promptly notify the 
        individual of the denial.
            (5) Expedited review.--Regulations under 
        subsections (b) and (c) shall provide for a procedure 
        through which, upon request to the Secretary by a 
        registered person who submits names and other 
        identifying information under paragraph (2)(B) and who 
        demonstrates good cause, the Secretary may, as 
        determined appropriate by the Secretary--
                    (A) request the Attorney General to 
                expedite the process of identification under 
                paragraph (3)(A) and notification of the 
                Secretary under paragraph (3)(C); and
                    (B) expedite the notification of the 
                registered person by the Secretary under 
                paragraph (4).
            (6) Process regarding persons seeking to 
        register.--
                    (A) Individuals.--Regulations under 
                subsections (b) and (c) shall provide that an 
                individual who seeks to register under either 
                of such subsections is subject to the same 
                processes described in paragraphs (2) through 
                (4) as apply to names and other identifying 
                information submitted to the Attorney General 
                under paragraph (2)(B). Paragraph (5) does not 
                apply for purposes of this subparagraph.
                    (B) Other persons.--Regulations under 
                subsections (b) and (c) shall provide that, in 
                determining whether to deny or revoke 
                registration by a person other than an 
                individual, the Secretary shall submit the name 
                of such person to the Attorney General, who 
                shall use criminal, immigration, national 
                security, and other electronic databases 
                available to the Federal Government, as 
                appropriate for the purpose of promptly 
                notifying the Secretary whether the person, or, 
                where relevant, the individual who owns or 
                controls such person, is a restricted person or 
                is reasonably suspected by any Federal law 
                enforcement or intelligence agency of being 
                within any category specified in paragraph 
                (3)(B)(ii) (as applied to persons, including 
                individuals). Such regulations shall provide 
                that a person who seeks to register under 
                either of such subsections is subject to the 
                same processes described in paragraphs (2) and 
                (4) as apply to names and other identifying 
                information submitted to the Attorney General 
                under paragraph (2)(B). Paragraph (5) does not 
                apply for purposes of this subparagraph. The 
                Secretary may exempt Federal, State, or local 
                governmental agencies from the requirements of 
                this subparagraph.
            (7) Review.--
                    (A) Administrative review.--
                            (i) In general.--Regulations under 
                        subsections (b) and (c) shall provide 
                        for an opportunity for a review by the 
                        Secretary--
                                    (I) when requested by the 
                                individual involved, of a 
                                determination under paragraph 
                                (2) to deny the individual 
                                access to listed agents and 
                                toxins; and
                                    (II) when requested by the 
                                person involved, of a 
                                determination under paragraph 
                                (6) to deny or revoke 
                                registration for such person.
                            (ii) Ex parte review.--During a 
                        review under clause (i), the Secretary 
                        may consider information relevant to 
                        the review ex parte to the extent that 
                        disclosure of the information could 
                        compromise national security or an 
                        investigation by any law enforcement 
                        agency.
                            (iii) Final agency action.--The 
                        decision of the Secretary in a review 
                        under clause (i) constitutes final 
                        agency action for purposes of section 
                        702 of title 5, United States Code.
                    (B) Certain procedures.--
                            (i) Submission of ex parte 
                        materials in judicial proceedings.--
                        When reviewing a decision of the 
                        Secretary under subparagraph (A), and 
                        upon request made ex parte and in 
                        writing by the United States, a court, 
                        upon a sufficient showing, may review 
                        and consider ex parte documents 
                        containing information the disclosure 
                        of which could compromise national 
                        security or an investigation by any law 
                        enforcement agency. If the court 
                        determines that portions of the 
                        documents considered ex parte should be 
                        disclosed to the person involved to 
                        allow a response, the court shall 
                        authorize the United States to delete 
                        from such documents specified items of 
                        information the disclosure of which 
                        could compromise national security or 
                        an investigation by any law enforcement 
                        agency, or to substitute a summary of 
                        the information to which the person may 
                        respond. Any order by the court 
                        authorizing the disclosure of 
                        information that the United States 
                        believes could compromise national 
                        security or an investigation by any law 
                        enforcement agency shall be subject to 
                        the processes set forth in 
                        subparagraphs (A) and (B)(i) of section 
                        2339B(f)(5) of title 18, United States 
                        Code (relating to interlocutory appeal 
                        and expedited consideration).
                            (ii) Disclosure of information.--In 
                        a review under subparagraph (A), and in 
                        any judical proceeding conducted 
                        pursuant to such review, neither the 
                        Secretary nor the Attorney General may 
                        be required to disclose to the public 
                        any information that under subsection 
                        (h) shall not be disclosed under 
                        section 552 of title 5, United States 
                        Code.
            (8) Notifications regarding theft or loss of 
        agents.--Requirements under paragraph (1) shall include 
        the prompt notification of the Secretary, and 
        appropriate Federal, State, and local law enforcement 
        agencies, of the theft or loss of listed agents and 
        toxins.
            (9) Technical assistance for registered persons.--
        The Secretary, in consultation with the Attorney 
        General, may provide technical assistance to registered 
        persons to improve security of the facilities of such 
        persons.
    (f) Inspections.--The Secretary shall have the authority to 
inspect persons subject to regulations under subsection (b) or 
(c) to ensure their compliance with such regulations, including 
prohibitions on restricted persons and other provisions of 
subsection (e).
    (g) Exemptions.--
            (1) Clinical or diagnostic laboratories.--
        Regulations under subsections (b) and (c) shall exempt 
        clinical or diagnostic laboratories and other persons 
        who possess, use, or transfer listed agents or toxins 
        that are contained in specimens presented for 
        diagnosis, verification, or proficiency testing, 
        provided that--
                    (A) the identification of such agents or 
                toxins is reported to the Secretary, and when 
                required under Federal, State, or local law, to 
                other appropriate authorities; and
                    (B) such agents or toxins are transferred 
                or destroyed in a manner set forth by the 
                Secretary by regulation.
            (2) Products.--
                    (A) In general.--Regulations under 
                subsections (b) and (c) shall exempt products 
                that are, bear, or contain listed agents or 
                toxins and are cleared, approved, licensed, or 
                registered under any of the Acts specified in 
                subparagraph (B), unless the Secretary by order 
                determines that applying additional regulation 
                under subsection (b) or (c) to a specific 
                product is necessary to protect public health 
                and safety.
                    (B) Relevant laws.--For purposes of 
                subparagraph (A), the Acts specified in this 
                subparagraph are the following:
                            (i) The Federal Food, Drug, and 
                        Cosmetic Act.
                            (ii) Section 351 of this Act.
                            (iii) The Act commonly known as the 
                        Virus-Serum-Toxin Act (the eighth 
                        paragraph under the heading ``Bureau of 
                        Animal Industry'' in the Act of March 
                        4, 1913; 21 U.S.C. 151-159).
                            (iv) The Federal Insecticide, 
                        Fungicide, and Rodenticide Act.
                    (C) Investigational use.--
                            (i) In general.--The Secretary may 
                        exempt an investigational product that 
                        is, bears, or contains a listed agent 
                        or toxin from the applicability of 
                        provisions of regulations under 
                        subsection (b) or (c) when such product 
                        is being used in an investigation 
                        authorized under any Federal Act and 
                        the Secretary determines that applying 
                        additional regulation under subsection 
                        (b) or (c) to such product is not 
                        necessary to protect public health and 
                        safety.
                            (ii) Certain processes.--
                        Regulations under subsections (b) and 
                        (c) shall set forth the procedures for 
                        applying for an exemption under clause 
                        (i). In the case of investigational 
                        products authorized under any of the 
                        Acts specified in subparagraph (B), the 
                        Secretary shall make a determination 
                        regarding a request for an exemption 
                        not later than 14 days after the first 
                        date on which both of the following 
                        conditions have been met by the person 
                        requesting the exemption:
                                    (I) The person has 
                                submitted to the Secretary an 
                                application for the exemption 
                                meeting the requirements 
                                established by the Secretary.
                                    (II) The person has 
                                notified the Secretary that the 
                                investigation has been 
                                authorized under such an Act.
            (3) Public health emergencies.--The Secretary may 
        temporarily exempt a person from the applicability of 
        the requirements of this section, in whole or in part, 
        if the Secretary determines that such exemption is 
        necessary to provide for the timely participation of 
        the person in a response to a domestic or foreign 
        public health emergency (whether determined under 
        section 319(a) or otherwise) that involves a listed 
        agent or toxin. With respect to the emergency involved, 
        such exemption for a person may not exceed 30 days, 
        except that the Secretary, after review of whether such 
        exemption remains necessary, may provide one extension 
        of an additional 30 days.
            (4) Agricultural emergencies.--Upon request of the 
        Secretary of Agriculture, after the granting by such 
        Secretary of an exemption under section 212(g)(1)(D) of 
        the Agricultural Bioterrorism Protection Act of 2002 
        pursuant to a finding that there is an agricultural 
        emergency, the Secretary of Health and Human Services 
        may temporarily exempt a person from the applicability 
        of the requirements of this section, in whole or in 
        part, to provide for the timely participation of the 
        person in a response to the agricultural emergency. 
        With respect to the emergency involved, the exemption 
        under this paragraph for a person may not exceed 30 
        days, except that upon request of the Secretary of 
        Agriculture, the Secretary of Health and Human Services 
        may, after review of whether such exemption remains 
        necessary, provide one extension of an additional 30 
        days.
    (h) Disclosure of Information.--
            (1) Nondisclosure of certain information.--No 
        Federal agency specified in paragraph (2) shall 
        disclose under section 552 of title 5, United States 
        Code, any of the following:
                    (A) Any registration or transfer 
                documentation submitted under subsections (b) 
                and (c) for the possession, use, or transfer of 
                a listed agent or toxin; or information derived 
                therefrom to the extent that it identifies the 
                listed agent or toxin possessed, used, or 
                transferred by a specific registered person or 
                discloses the identity or location of a 
                specific registered person.
                    (B) The national database developed 
                pursuant to subsection (d), or any other 
                compilation of the registration or transfer 
                information submitted under subsections (b) and 
                (c) to the extent that such compilation 
                discloses site-specific registration or 
                transfer information.
                    (C) Any portion of a record that discloses 
                the site-specific or transfer-specific 
                safeguard and security measures used by a 
                registered person to prevent unauthorized 
                access to listed agents and toxins.
                    (D) Any notification of a release of a 
                listed agent or toxin submitted under 
                subsections (b) and (c), or any notification of 
                theft or loss submitted under such subsections.
                    (E) Any portion of an evaluation or report 
                of an inspection of a specific registered 
                person conducted under subsection (f) that 
                identifies the listed agent or toxin possessed 
                by a specific registered person or that 
                discloses the identity or location of a 
                specific registered person if the agency 
                determines that public disclosure of the 
                information would endanger public health or 
                safety.
            (2) Covered agencies.--For purposes of paragraph 
        (1) only, the Federal agencies specified in this 
        paragraph are the following:
                    (A) The Department of Health and Human 
                Services, the Department of Justice, the 
                Department of Agriculture, and the Department 
                of Transportation.
                    (B) Any Federal agency to which information 
                specified in paragraph (1) is transferred by 
                any agency specified in subparagraph (A) of 
                this paragraph.
                    (C) Any Federal agency that is a registered 
                person, or has a sub-agency component that is a 
                registered person.
                    (D) Any Federal agency that awards grants 
                or enters into contracts or cooperative 
                agreements involving listed agents and toxins 
                to or with a registered person, and to which 
                information specified in paragraph (1) is 
                transferred by any such registered person.
            (3) Other exemptions.--This subsection may not be 
        construed as altering the application of any exemptions 
        to public disclosure under section 552 of title 5, 
        United States Code, except as to subsection 552(b)(3) 
        of such title, to any of the information specified in 
        paragraph (1).
            (4) Rule of construction.--Except as specifically 
        provided in paragraph (1), this subsection may not be 
        construed as altering the authority of any Federal 
        agency to withhold under section 552 of title 5, United 
        States Code, or the obligation of any Federal agency to 
        disclose under section 552 of title 5, United States 
        Code, any information, including information relating 
        to--
                    (A) listed agents and toxins, or 
                individuals seeking access to such agents and 
                toxins;
                    (B) registered persons, or persons seeking 
                to register their possession, use, or transfer 
                of such agents and toxins;
                    (C) general safeguard and security policies 
                and requirements under regulations under 
                subsections (b) and (c); or
                    (D) summary or statistical information 
                concerning registrations, registrants, denials 
                or revocations of registrations, listed agents 
                and toxins, inspection evaluations and reports, 
                or individuals seeking access to such agents 
                and toxins.
            (5) Disclosures to congress; other disclosures.--
        This subsection may not be construed as providing any 
        authority--
                    (A) to withhold information from the 
                Congress or any committee or subcommittee 
                thereof; or
                    (B) to withhold information from any person 
                under any other Federal law or treaty.
    (i) Civil Money Penalty.-- \1\
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    \1\ Section 175b of title 18, United States Code, establishes 
criminal penalties relating to biological agents or toxins that are 
listed as select agents in Appendix A of part 72 of title 42, Code of 
Federal Regulations, pursuant to section 351A above, and are not 
exempted under subsection (h) of section 72.6, or Appendix A of part 
72, of title 42, Code of Federal Regulations.
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            (1) In general.--In addition to any other penalties 
        that may apply under law, any person who violates any 
        provision of regulations under subsection (b) or (c) 
        shall be subject to the United States for a civil money 
        penalty in an amount not exceeding $250,000 in the case 
        of an individual and $500,000 in the case of any other 
        person.
            (2) Applicability of certain provisions.--The 
        provisions of section 1128A of the Social Security Act 
        (other than subsections (a), (b), (h), and (i), the 
        first sentence of subsection (c), and paragraphs (1) 
        and (2) of subsection (f)) shall apply to a civil money 
        penalty under paragraph (1) in the same manner as such 
        provisions apply to a penalty or proceeding under 
        section 1128A(a) of such Act. The Secretary may 
        delegate authority under this subsection in the same 
        manner as provided in section 1128A(j)(2) of the Social 
        Security Act, and such authority shall include all 
        powers as contained in section 6 of the Inspector 
        General Act of 1978 (5 U.S.C. App.).
    (j) Notification in Event of Release.--Regulations under 
subsections (b) and (c) shall require the prompt notification 
of the Secretary by a registered person whenever a release, 
meeting criteria established by the Secretary, of a listed 
agent or toxin has occurred outside of the biocontainment area 
of a facility of the registered person. Upon receipt of such 
notification and a finding by the Secretary that the release 
poses a threat to public health or safety, the Secretary shall 
take appropriate action to notify relevant State and local 
public health authorities, other relevant Federal authorities, 
and, if necessary, other appropriate persons (including the 
public). If the released listed agent or toxin is an overlap 
agent or toxin (as defined in subsection (l)), the Secretary 
shall promptly notify the Secretary of Agriculture upon 
notification by the registered person.
    (k) Reports.--The Secretary shall report to the Congress 
annually on the number and nature of notifications received 
under subsection (e)(8) (relating to theft or loss) and 
subsection (j) (relating to releases).
    (l) Definitions.--For purposes of this section:
            (1) The terms ``biological agent'' and ``toxin'' 
        have the meanings given such terms in section 178 of 
        title 18, United States Code.
            (2) The term ``listed agents and toxins'' means 
        biological agents and toxins listed pursuant to 
        subsection (a)(1).
            (3) The term ``listed agents or toxins'' means 
        biological agents or toxins listed pursuant to 
        subsection (a)(1).
            (4) The term ``overlap agents and toxins'' means 
        biological agents and toxins that--
                    (A) are listed pursuant to subsection 
                (a)(1); and
                    (B) are listed pursuant to section 
                212(a)(1) of the Agricultural Bioterrorism 
                Protection Act of 2002.
            (5) The term ``overlap agent or toxin'' means a 
        biological agent or toxin that--
                    (A) is listed pursuant to subsection 
                (a)(1); and
                    (B) is listed pursuant to section 212(a)(1) 
                of the Agricultural Bioterrorism Protection Act 
                of 2002.
            (6) The term ``person'' includes Federal, State, 
        and local governmental entities.
            (7) The term ``registered person'' means a person 
        registered under regulations under subsection (b) or 
        (c).
            (8) The term ``restricted person'' has the meaning 
        given such term in section 175b of title 18, United 
        States Code.
    (m) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2002 through 2007.

                   preparation of biological products

    Sec. 352. [263] (a) The Service may prepare for its own use 
any product described in section 351 and any product necessary 
to carrying out any of the purposes of section 301.
    (b) The Service may prepare any product described in 
section 351 for the use of other Federal departments or 
agencies, and public or private agencies and individuals 
engaged in work in the field of medicine when such product is 
not available from establishments licensed under such section.

                    Subpart 2--Clinical Laboratories

             h3  deg.certification of laboratories
    Sec. 353. [263a] (a) Definition.--As used in this section, 
the term ``laboratory'' or ``clinical laboratory'' means a 
facility for the biological, microbiological, serological, 
chemical, immuno-hematological, hematological, biophysical, 
cytological, pathological, or other examination of materials 
derived from the human body for the purpose of providing 
information for the diagnosis, prevention, or treatment of any 
disease or impairment of, or the assessment of the health of, 
human beings.
    (b) Certificate Requirement.--No person may solicit or 
accept materials derived from the human body for laboratory 
examination or other procedure unless there is in effect for 
the laboratory a certificate issued by the Secretary under this 
section applicable to the category of examinations or 
procedures which includes such examination or procedure.
    (c) Issuance and Renewal of Certificates.--
            (1) In general.--The Secretary may issue or renew a 
        certificate for a laboratory only if the laboratory 
        meets the requirements of subsection (d).
            (2) Term.--A certificate issued under this section 
        shall be valid for a period of 2 years or such shorter 
        period as the Secretary may establish.
    (d) Requirements for Certificates.--
            (1) In general.--A laboratory may be issued a 
        certificate or have its certificate renewed if--
                    (A) the laboratory submits (or if the 
                laboratory is accredited under subsection (e), 
                the accreditation body which accredited the 
                laboratory submits), an application--
                            (i) in such form and manner as the 
                        Secretary shall prescribe,
                            (ii) that describes the 
                        characteristics of the laboratory 
                        examinations and other procedures 
                        performed by the laboratory including--
                                    (I) the number and types of 
                                laboratory examinations and 
                                other procedures performed,
                                    (II) the methodologies for 
                                laboratory examinations and 
                                other procedures employed, and
                                    (III) the qualifications 
                                (educational background, 
                                training, and experience) of 
                                the personnel directing and 
                                supervising the laboratory and 
                                performing the laboratory 
                                examinations and other 
                                procedures, and
                            (iii) that contains such other 
                        information as the Secretary may 
                        require to determine compliance with 
                        this section, and
                the laboratory agrees to provide to the 
                Secretary (or if the laboratory is accredited, 
                to the accreditation body which accredited it) 
                a description of any change in the information 
                submitted under clause (ii) not later than 6 
                months after the change was put into effect,
                    (B) the laboratory provides the Secretary--
                            (i) with satisfactory assurances 
                        that the laboratory will be operated in 
                        accordance with standards issued by the 
                        Secretary under subsection (f), or
                            (ii) with proof of accreditation 
                        under subsection (e),
                    (C) the laboratory agrees to permit 
                inspections by the Secretary under subsection 
                (g),
                    (D) the laboratory agrees to make records 
                available and submit reports to the Secretary 
                as the Secretary may reasonably require, and
                    (E) the laboratory agrees to treat 
                proficiency testing samples in the same manner 
                as it treats materials derived from the human 
                body referred to it for laboratory examinations 
                or other procedures in the ordinary course of 
                business.
            (2) Requirements for certificates of waiver.--
                    (A) In general.--A laboratory which only 
                performs laboratory examinations and procedures 
                described in paragraph (3) shall be issued a 
                certificate of waiver or have its certificate 
                of waiver renewed if--
                            (i) the laboratory submits an 
                        application--
                                    (I) in such form and manner 
                                as the Secretary shall 
                                prescribe,
                                    (II) that describes the 
                                characteristics of the 
                                laboratory examinations and 
                                other procedures performed by 
                                the laboratory, including the 
                                number and types of laboratory 
                                examinations and other 
                                procedures performed, the 
                                methodologies for laboratory 
                                examinations and other 
                                procedures employed, and the 
                                qualifications (educational 
                                background, training, and 
                                experience) of the personnel 
                                directing and supervising the 
                                laboratory and performing the 
                                laboratory examinations and 
                                other procedures, and
                                    (III) that contains such 
                                other information as the 
                                Secretary may reasonably 
                                require to determine compliance 
                                with this section, and
                            (ii) the laboratory agrees to make 
                        records available and submit reports to 
                        the Secretary as the Secretary may 
                        require.
                    (B) Changes.--If a laboratory makes changes 
                in the examinations and other procedures 
                performed by it only with respect to 
                examinations and procedures which are described 
                in paragraph (3), the laboratory shall report 
                such changes to the Secretary not later than 6 
                months after the change has been put into 
                effect. If a laboratory proposes to make 
                changes in the examinations and procedures 
                performed by it such that the laboratory will 
                perform an examination or procedure not 
                described in paragraph (3), the laboratory 
                shall report such change to the Secretary 
                before the change takes effect.
                    (C) Effect.--Subsections (f) and (g) shall 
                not apply to a laboratory to which has been 
                issued a certificate of waiver.
            (3) Examinations and procedures.--The examinations 
        and procedures identified in paragraph (2) are 
        laboratory examinations and procedures that have been 
        approved by the Food and Drug Administration for home 
        use or that, as determined by the Secretary, are simple 
        laboratory examinations and procedures that have an 
        insignificant risk of an erroneous result, including 
        those that--
                    (A) employ methodologies that are so simple 
                and accurate as to render the likelihood of 
                erroneous results by the user negligible, or
                    (B) the Secretary has determined pose no 
                unreasonable risk of harm to the patient if 
                performed incorrectly.
            (4) Definition.--As used in this section, the term 
        ``certificate'' includes a certificate of waiver issued 
        under paragraph (2).
    (e) Accreditation.--
            (1) In general.--A laboratory may be accredited for 
        purposes of obtaining a certificate if the laboratory--
                    (A) meets the standards of an approved 
                accreditation body, and
                    (B) authorizes the accreditation body to 
                submit to the Secretary (or such State agency 
                as the Secretary may designate) such records or 
                other information as the Secretary may require.
            (2) Approval of accreditation bodies.--
                    (A) In general.--The Secretary may approve 
                a private nonprofit organization to be an 
                accreditation body for the accreditation of 
                laboratories if--
                            (i) using inspectors qualified to 
                        evaluate the methodologies used by the 
                        laboratories in performing laboratory 
                        examinations and other procedures, the 
                        accreditation body agrees to inspect a 
                        laboratory for purposes of 
                        accreditation with such frequency as 
                        determined by Secretary, \1\
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    \1\ So in law. Probably should be ``the Secretary''.
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                            (ii) the standards applied by the 
                        body in determining whether or not to 
                        accredit a laboratory are equal to or 
                        more stringent than the standards 
                        issued by the Secretary under 
                        subsection (f),
                            (iii) there is adequate provision 
                        for assuring that the standards of the 
                        accreditation body continue to be met 
                        by the laboratory,
                            (iv) in the case of any laboratory 
                        accredited by the body which has had 
                        its accreditation denied, suspended, 
                        withdrawn, or revoked or which has had 
                        any other action taken against it by 
                        the accrediting body, the accrediting 
                        body agrees to submit to the Secretary 
                        the name of such laboratory within 30 
                        days of the action taken,
                            (v) the accreditation body agrees 
                        to notify the Secretary at least 30 
                        days before it changes its standards, 
                        and
                            (vi) if the accreditation body has 
                        its approval withdrawn by the 
                        Secretary, the body agrees to notify 
                        each laboratory accredited by the body 
                        of the withdrawal within 10 days of the 
                        withdrawal.
                    (B) Criteria and procedures.--The Secretary 
                shall promulgate criteria and procedures for 
                approving an accreditation body and for 
                withdrawing such approval if the Secretary 
                determines that the accreditation body does not 
                meet the requirements of subparagraph (A).
                    (C) Effect of withdrawal of approval.--If 
                the Secretary withdraws the approval of an 
                accreditation body under subparagraph (B), the 
                certificate of any laboratory accredited by the 
                body shall continue in effect for 60 days after 
                the laboratory receives notification of the 
                withdrawal of the approval, except that the 
                Secretary may extend such period for a 
                laboratory if it \1\ determines that the 
                laboratory submitted an application for 
                accreditation or a certificate in a timely 
                manner after receipt of the notification of the 
                withdrawal of approval. If an accreditation 
                body withdraws or revokes the accreditation of 
                a laboratory, the certificate of the laboratory 
                shall continue in effect--
                            (i) for 45 days after the 
                        laboratory receives notice of the 
                        withdrawal or revocation of the 
                        accreditation, or
                            (ii) until the effective date of 
                        any action taken by the Secretary under 
                        subsection (i).
                    (D) Evaluations.--The Secretary shall 
                evaluate annually the performance of each 
                approved accreditation body by--
                            (i) inspecting under subsection (g) 
                        a sufficient number of the laboratories 
                        accredited by such body to allow a 
                        reasonable estimate of the performance 
                        of such body, and
                            (ii) such other means as the 
                        Secretary determines appropriate.
            (3) Report.--The Secretary shall annually prepare 
        and submit, to the Committee on Energy and Commerce of 
        the House of Representatives and the Committee on Labor 
        and Human Resources of the Senate, a report that 
        describes the results of the evaluation conducted under 
        paragraph (2)(D).
    (f) \1\ Standards.--
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    \1\ Section 3 of Public Law 100-578 provides that, with respect to 
subsection (g)(1) and subsections (h) through (m), any reference made 
in any of such subsections to the standards established under 
subsection (f) ``shall be considered a reference to the standards 
established under subsection (d) [of section 353], as in effect on 
December 31, 1988.''.
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            (1) In general.--The Secretary shall issue 
        standards to assure consistent performance by 
        laboratories issued a certificate under this section of 
        valid and reliable laboratory examinations and other 
        procedures. Such standards shall require each 
        laboratory issued a certificate under this section--
                    (A) to maintain a quality assurance and 
                quality control program adequate and 
                appropriate for the validity and reliability of 
                the laboratory examinations and other 
                procedures of the laboratory and to meet 
                requirements relating to the proper collection, 
                transportation, and storage of specimens and 
                the reporting of results,
                    (B) to maintain records, equipment, and 
                facilities necessary for the proper and 
                effective operation of the laboratory,
                    (C) in performing and carrying out its 
                laboratory examinations and other procedures, 
                to use only personnel meeting such 
                qualifications as the Secretary may establish 
                for the direction, supervision, and performance 
                of examinations and procedures within the 
                laboratory, which qualifications shall take 
                into consideration competency, training, 
                experience, job performance, and education and 
                which qualifications shall, as appropriate, be 
                different on the basis of the type of 
                examinations and procedures being performed by 
                the laboratory and the risks and consequences 
                of erroneous results associated with such 
                examinations and procedures,
                    (D) to qualify under a proficiency testing 
                program meeting the standards established by 
                the Secretary under paragraph (3), and
                    (E) to meet such other requirements as the 
                Secretary determines necessary to assure 
                consistent performance by such laboratories of 
                accurate and reliable laboratory examinations 
                and procedures.
            (2) Considerations.--In developing the standards to 
        be issued under paragraph (1), the Secretary shall, 
        within the flexibility provided under subparagraphs (A) 
        through (E) of paragraph (1), take into consideration--
                    (A) the examinations and procedures 
                performed and the methodologies employed,
                    (B) the degree of independent judgment 
                involved,
                    (C) the amount of interpretation involved,
                    (D) the difficulty of the calculations 
                involved,
                    (E) the calibration and quality control 
                requirements of the instruments used,
                    (F) the type of training required to 
                operate the instruments used in the 
                methodology, and
                    (G) such other factors as the Secretary 
                considers relevant.
            (3) Proficiency testing program.--
                    (A) In general.--The Secretary shall 
                establish standards for the proficiency testing 
                programs for laboratories issued a certificate 
                under this section which are conducted by the 
                Secretary, conducted by an organization 
                approved under subparagraph (C), or conducted 
                by an approved accrediting body. The standards 
                shall require that a laboratory issued a 
                certificate under this section be tested for 
                each examination and procedure conducted within 
                a category of examinations or procedures for 
                which it has received a certificate, except for 
                examinations and procedures for which the 
                Secretary has determined that a proficiency 
                test cannot reasonably be developed. The 
                testing shall be conducted on a quarterly 
                basis, except where the Secretary determines 
                for technical and scientific reasons that a 
                particular examination or procedure may be 
                tested less frequently (but not less often than 
                twice per year).
                    (B) Criteria.--The standards established 
                under subparagraph (A) shall include uniform 
                criteria for acceptable performance under a 
                proficiency testing program, based on the 
                available technology and the clinical relevance 
                of the laboratory examination or other 
                procedure subject to such program. The criteria 
                shall be established for all examinations and 
                procedures and shall be uniform for each 
                examination and procedure. The standards shall 
                also include a system for grading proficiency 
                testing performance to determine whether a 
                laboratory has performed acceptably for a 
                particular quarter and acceptably for a 
                particular examination or procedure or category 
                of examination or procedure over a period of 
                successive quarters.
                    (C) Approved proficiency testing 
                programs.--For the purpose of administering 
                proficiency testing programs which meet the 
                standards established under subparagraph (A), 
                the Secretary shall approve a proficiency 
                testing program offered by a private nonprofit 
                organization or a State if the program meets 
                the standards established under subparagraph 
                (A) and the organization or State provides 
                technical assistance to laboratories seeking to 
                qualify under the program. The Secretary shall 
                evaluate each program approved under this 
                subparagraph annually to determine if the 
                program continues to meet the standards 
                established under subparagraph (A) and shall 
                withdraw the approval of any program that no 
                longer meets such standards.
                    (D) On-site \1\ testing.--The Secretary 
                shall perform, or shall direct a program 
                approved under subparagraph (C) to perform, 
                onsite proficiency testing to assure compliance 
                with the requirements of subsection (d)(5) \2\. 
                The Secretary shall perform, on an onsite or 
                other basis, proficiency testing to evaluate 
                the performance of a proficiency testing 
                program approved under subparagraph (C) and to 
                assure quality performance by a laboratory.
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    \1\ So in law. Probably should not be hyphenated. Compare with text 
of subparagraph (D).
    \2\ So in law. Probably should be ``(d)(1)(E)''.
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                    (E) Training, technical assistance, and 
                enhanced proficiency testing.--The Secretary 
                may, in lieu of or in addition to actions 
                authorized under subsection (h), (i), or (j), 
                require any laboratory which fails to perform 
                acceptably on an individual examination and 
                procedure or a category of examination and 
                procedures--
                            (i) to undertake training and to 
                        obtain the necessary technical 
                        assistance to meet the requirements of 
                        the proficency \1\ testing program,
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    \1\ So in law. Probably should be ``proficiency''.
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                            (ii) to enroll in a program of 
                        enhanced proficiency testing, or
                            (iii) to undertake any combination 
                        of the training, technical assistance, 
                        or testing described in clauses (i) and 
                        (ii).
                    (F) Testing results.--The Secretary shall 
                establish a system to make the results of the 
                proficiency testing programs subject to the 
                standards established by the Secretary under 
                subparagraph (A) available, on a reasonable 
                basis, upon request of any person. The 
                Secretary shall include with results made 
                available under this subparagraph such 
                explanatory information as may be appropriate 
                to assist in the interpretation of such 
                results.
            (4) National standards for quality assurance in 
        cytology services.--
                    (A) Establishment.--The Secretary shall 
                establish national standards for quality 
                assurance in cytology services designed to 
                assure consistent performance by laboratories 
                of valid and reliable cytological services.
                    (B) Standards.--The standards established 
                under subparagraph (A) shall include--
                            (i) the maximum number of cytology 
                        slides that any individual may screen 
                        in a 24-hour period,
                            (ii) requirements that a clinical 
                        laboratory maintain a record of (I) the 
                        number of cytology slides screened 
                        during each 24-hour period by each 
                        individual who examines cytology slides 
                        for the laboratory, and (II) the number 
                        of hours devoted during each 24-hour 
                        period to screening cytology slides by 
                        such individual,
                            (iii) criteria for requiring 
                        rescreening of cytological 
                        preparations, such as (I) random 
                        rescreening of cytology specimens 
                        determined to be in the benign 
                        category, (II) focused rescreening of 
                        such preparations in high risk groups, 
                        and (III) for each abnormal cytological 
                        result, rescreening of all prior 
                        cytological specimens for the patient, 
                        if available,
                            (iv) periodic confirmation and 
                        evaluation of the proficiency of 
                        individuals involved in screening or 
                        interpreting cytological preparations, 
                        including announced and unannounced on-
                        site \2\ proficiency testing of such 
                        individuals, with such testing to take 
                        place, to the extent practicable, under 
                        normal working conditions,
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    \2\ See footnote 1 for paragraph (3)(D).
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                            (v) procedures for detecting 
                        inadequately prepared slides, for 
                        assuring that no cytological diagnosis 
                        is rendered on such slides, and for 
                        notifying referring physicians of such 
                        slides,
                            (vi) requirements that all 
                        cytological screening be done on the 
                        premises of a laboratory that is 
                        certified under this section,
                            (vii) requirements for the 
                        retention of cytology slides by 
                        laboratories for such periods of time 
                        as the Secretary considers appropriate, 
                        and
                            (viii) standards requiring periodic 
                        inspection of cytology services by 
                        persons capable of evaluating the 
                        quality of cytology services.
    (g) Inspections.--
            (1) in general.--The Secretary may, on an announced 
        or unannounced basis, enter and inspect, during regular 
        hours of operation, laboratories which have been issued 
        a certificate under this section. In conducting such 
        inspections the Secretary shall have access to all 
        facilities, equipment, materials, records, and 
        information that the Secretary determines have a 
        bearing on whether the laboratory is being operated in 
        accordance with this section. As part of such an 
        inspection the Secretary may copy any such material or 
        require to it be \1\ submitted to the Secretary. An 
        inspection under this paragraph may be made only upon 
        presenting identification to the owner, operator, or 
        agent in charge of the laboratory being inspected.
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    \1\ So in law. Probably should be ``require it to be''.
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            (2) Compliance with requirements and standards.--
        The Secretary shall conduct inspections of laboratories 
        under paragraph (1) to determine their compliance with 
        the requirements of subsection (d) and the standards 
        issued under subsection (f). Inspections of 
        laboratories not accredited under subsection (e) shall 
        be conducted on a biennial basis or with such other 
        frequency as the Secretary determines to be necessary 
        to assure compliance with such requirements and 
        standards. Inspections of laboratories accredited under 
        subsection (e) shall be conducted on such basis as the 
        Secretary determines is necessary to assure compliance 
        with such requirements and standards.
    (h) Intermediate Sanctions.--
            (1) In general.--If the Secretary determines that a 
        laboratory which has been issued a certificate under 
        this section no longer substantially meets the 
        requirements for the issuance of a certificate, the 
        Secretary may impose intermediate sanctions in lieu of 
        the actions authorized by subsection (i).
            (2) Types of sanctions.--The intermediate sanctions 
        which may be imposed under paragraph (1) shall consist 
        of--
                    (A) directed plans of correction,
                    (B) civil money penalties in an amount not 
                to exceed $10,000 for each violation listed in 
                subsection (i)(1) or for each day of 
                substantial noncompliance with the requirements 
                of this section,
                    (C) payment for the costs of onsite 
                monitoring, or
                    (D) any combination of the actions 
                described in subparagraphs (A), (B), and (C).
            (3) Procedures.--The Secretary shall develop and 
        implement procedures with respect to when and how each 
        of the intermediate sanctions is to be imposed under 
        paragraph (1). Such procedures shall provide for notice 
        to the laboratory and a reasonable opportunity to 
        respond to the proposed sanction and appropriate 
        procedures for appealing determinations relating to the 
        imposition of intermediate sanctions \1\
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    \1\ So in law. The sentence lacks a period.
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    (i) Suspension, Revocation, and Limitation.--
            (1) In general.--Except as provided in paragraph 
        (2), the certificate of a laboratory issued under this 
        section may be suspended, revoked, or limited if the 
        Secretary finds, after reasonable notice and 
        opportunity for hearing to the owner or operator of the 
        laboratory, that such owner or operator or any employee 
        of the laboratory--
                    (A) has been guilty of misrepresentation in 
                obtaining the certificate,
                    (B) has performed or represented the 
                laboratory as entitled to perform a laboratory 
                examination or other procedure which is not 
                within a category of laboratory examinations or 
                other procedures authorized in the certificate,
                    (C) has failed to comply with the 
                requirements of subsection (d) or the standards 
                prescribed by the Secretary under subsection 
                (f),
                    (D) has failed to comply with reasonable 
                requests of the Secretary for--
                            (i) any information or materials, 
                        or
                            (ii) work on materials,
                that the Secretary concludes is necessary to 
                determine the laboratory's continued 
                eligibility for its certificate or continued 
                compliance with the Secretary's standards under 
                subsection (f),
                    (E) has refused a reasonable request of the 
                Secretary, or any Federal officer or employee 
                duly designated by the Secretary, for 
                permission to inspect the laboratory and its 
                operations and pertinent records during the 
                hours the laboratory is in operation,
                    (F) has violated or aided and abetted in 
                the violation of any provisions of this section 
                or of any regulation promulgated thereunder, or
                    (G) has not complied with an intermediate 
                sanction imposed under subsection (h).
            (2) Action before a hearing.--If the Secretary 
        determines that--
                    (A) the failure of a laboratory to comply 
                with the standards of the Secretary under 
                subsection (f) presents an imminent and serious 
                risk to human health, or
                    (B) a laboratory has engaged in an action 
                described in subparagraph (D) or (E) of 
                paragraph (1),
        the Secretary may suspend or limit the certificate of 
        the laboratory before holding a hearing under paragraph 
        (1) regarding such failure or refusal. The opportunity 
        for a hearing shall be provided no later than 60 days 
        from the effective date of the suspension or 
        limitation. A suspension or limitation under this 
        paragraph shall stay in effect until the decision of 
        the Secretary made after the hearing under paragraph 
        (1).
            (3) Ineligibility to own or operate laboratories 
        after revocation.--No person who has owned or operated 
        a laboratory which has had its certificate revoked may, 
        within 2 years of the revocation of the certificate, 
        own or operate a laboratory for which a certificate has 
        been issued under this section. The certificate of a 
        laboratory which has been excluded from participation 
        under the medicare program under title XVIII of the 
        Social Security Act because of actions relating to the 
        quality of the laboratory shall be suspended for the 
        period the laboratory is so excluded.
            (4) Improper referrals.--Any laboratory that the 
        Secretary determines intentionally refers its 
        proficiency testing samples to another laboratory for 
        analysis shall have its certificate revoked for at 
        least one year and shall be subject to appropriate 
        fines and penalties as provided for in subsection (h).
    (j) Injunctions.--Whenever the Secretary has reason to 
believe that continuation of any activity by a laboratory would 
constitute a significant hazard to the public health the 
Secretary may bring suit in the district court of the United 
States for the district in which such laboratory is situated to 
enjoin continuation of such activity. Upon proper showing, a 
temporary injunction or restraining order against continuation 
of such activity pending issuance of a final order under this 
subsection shall be granted without bond by such court.
    (k) Judicial Review.--
            (1) Petition.--Any laboratory which has had an 
        intermediate sanction imposed under subsection (h) or 
        has had its certificate suspended, revoked, or limited 
        under subsection (i) may, at any time within 60 days 
        after the date the action of the Secretary under 
        subsection (i) or (h) becomes final, file a petition 
        with the United States court of appeals for the circuit 
        wherein the laboratory has its principal place of 
        business for judicial review of such action. As soon as 
        practicable after receipt of the petition, the clerk of 
        the court shall transmit a copy of the petition to the 
        Secretary or other officer designated by the Secretary 
        for that purpose. As soon as practicable after receipt 
        of the copy, the Secretary shall file in the court the 
        record on which the action of the Secretary is based, 
        as provided in section 2112 of title 28, United States 
        Code.
            (2) Additional evidence.--If the petitioner applies 
        to the court for leave to adduce additional evidence, 
        and shows to the satisfaction of the court that such 
        additional evidence is material and that there were 
        reasonable grounds for the failure to adduce such 
        evidence in the proceeding before the Secretary, the 
        court may order such additional evidence (and evidence 
        in rebuttal of such additional evidence) to be taken 
        before the Secretary, and to be adduced upon the 
        hearing in such manner and upon such terms and 
        conditions as the court may deem proper. The Secretary 
        may modify the findings of the Secretary as to the 
        facts, or make new findings, by reason of the 
        additional evidence so taken, and the Secretary shall 
        file such modified or new findings, and the 
        recommendations of the Secretary, if any, for the 
        modification or setting aside of his original action, 
        with the return of such additional evidence.
            (3) Judgment of court.--Upon the filing of the 
        petition referred to in paragraph (1), the court shall 
        have jurisdiction to affirm the action, or to set it 
        aside in whole or in part, temporarily or permanently. 
        The findings of the Secretary as to the facts, if 
        supported by substantial evidence, shall be conclusive.
            (4) Finality of judgment.--The judgment of the 
        court affirming or setting aside, in whole or in part, 
        any such action of the Secretary shall be final, 
        subject to review by the Supreme Court of the United 
        States upon certiorari or certification as provided in 
        section 1254 of title 28, United States Code.
    (l) Sanctions.--Any person who intentionally violates any 
requirement of this section or any regulation promulgated 
thereunder shall be imprisoned for not more than one year or 
fined under title 18, United States Code or both, except that 
if the conviction is for a second or subsequent violation of 
such a requirement such person shall be imprisoned for not more 
than 3 years or fined in accordance with title 18, United 
States Code or both.
    (m) Fees.--
            (1) Certificate fees.--The Secretary shall require 
        payment of fees for the issuance and renewal of 
        certificates, except that the Secretary shall only 
        require a nominal fee for the issuance and renewal of 
        certificates of waiver.
            (2) Additional fees.--The Secretary shall require 
        the payment of fees for inspections of laboratories 
        which are not accredited and for the cost of performing 
        proficiency testing on laboratories which do not 
        participate in proficiency testing programs approved 
        under subsection (f)(3)(C).
            (3) Criteria.--
                    (A) Fees under paragraph (1).--Fees imposed 
                under paragraph (1) shall be sufficient to 
                cover the general costs of administering this 
                section, including evaluating and monitoring 
                proficiency testing programs approved under 
                subsection (f) and accrediting bodies and 
                implementing and monitoring compliance with the 
                requirements of this section.
                    (B) Fees under paragraph (2).--Fees imposed 
                under paragraph (2) shall be sufficient to 
                cover the cost of the Secretary in carrying out 
                the inspections and proficiency testing 
                described in paragraph (2).
                    (C) Fees imposed under paragraphs (1) and 
                (2).--Fees imposed under paragraphs (1) and (2) 
                shall vary by group or classification of 
                laboratory, based on such considerations as the 
                Secretary determines are relevant, which may 
                include the dollar volume and scope of the 
                testing being performed by the laboratories.
    (n) Information.--On April 1, 1990 and annually thereafter, 
the Secretary shall compile and make available to physicians 
and the general public information, based on the previous 
calendar year, which the Secretary determines is useful in 
evaluating the performance of a laboratory, including--
            (1) a list of laboratories which have been 
        convicted under Federal or State laws relating to fraud 
        and abuse, false billings, or kickbacks,
            (2) a list of laboratories--
                    (A) which have had their certificates 
                revoked, suspended, or limited under subsection 
                (i), or
                    (B) which have been the subject of a 
                sanction under subsection (l),
        together with a statement of the reasons for the 
        revocation, suspension, limitation, or sanction,
            (3) a list of laboratories subject to intermediate 
        sanctions under subsection (h) together with a 
        statement of the reasons for the sanctions,
            (4) a list of laboratories whose accreditation has 
        been withdrawn or revoked together with a statement of 
        the reasons for the withdrawal or revocation,
            (5) a list of laboratories against which the 
        Secretary has taken action under subsection (j) 
        together with a statement of the reasons for such 
        action, and
            (6) a list of laboratories which have been excluded 
        from participation under title XVIII or XIX of the 
        Social Security Act.
The information to be compiled under paragraphs (1) through (6) 
shall be information for the calendar year preceding the date 
the information is to be made available to the public and shall 
be accompanied by such explanatory information as may be 
appropriate to assist in the interpretation of the information 
compiled under such paragraphs.
    (o) Delegation.--In carrying out this section, the 
Secretary may, pursuant to agreement, use the services or 
facilities of any Federal or State or local public agency or 
nonprofit private organization, and may pay therefor in advance 
or by way of reimbursement, and in such installments, as the 
Secretary may determine.
    (p) State Laws.--
            (1) Except as provided in paragraph (2), nothing in 
        this section shall be construed as affecting the power 
        of any State to enact and enforce laws relating to the 
        matters covered by this section to the extent that such 
        laws are not inconsistent with this section or with the 
        regulations issued under this section.
            (2) If a State enacts laws relating to matters 
        covered by this section which provide for requirements 
        equal to or more stringent than the requirements of 
        this section or than the regulations issued under this 
        section, the Secretary may exempt clinical laboratories 
        in that State from compliance with this section.
    (q) Consultations.--In carrying out this section, the 
Secretary shall consult with appropriate private organizations 
and public agencies.

                   Subpart 3--Mammography Facilities

SEC. 354. [263B] CERTIFICATION OF MAMMOGRAPHY FACILITIES.

    (a) Definitions.--As used in this section:
            (1) Accreditation body.--The term ``accreditation 
        body'' means a body that has been approved by the 
        Secretary under subsection (e)(1)(A) to accredit 
        mammography facilities.
            (2) Certificate.--The term ``certificate'' means 
        the certificate described in subsection (b)(1).
            (3) Facility.--
                    (A) In general.--The term ``facility'' 
                means a hospital, outpatient department, 
                clinic, radiology practice, or mobile unit, an 
                office of a physician, or other facility as 
                determined by the Secretary, that conducts 
                breast cancer screening or diagnosis through 
                mammography activities. Such term does not 
                include a facility of the Department of 
                Veterans Affairs.
                    (B) Activities.--For the purposes of this 
                section, the activities of a facility include 
                the operation of equipment to produce the 
                mammogram, the processing of the film, the 
                initial interpretation of the mammogram and the 
                viewing conditions for that interpretation. 
                Where procedures such as the film processing, 
                or the interpretation of the mammogram are 
                performed in a location different from where 
                the mammogram is performed, the facility 
                performing the mammogram shall be responsible 
                for meeting the quality standards described in 
                subsection (f).
            (4) Inspection.--The term ``inspection'' means an 
        onsite evaluation of the facility by the Secretary, or 
        State or local agency on behalf of the Secretary.
            (5) Mammogram.--The term ``mammogram'' means a 
        radiographic image produced through mammography.
            (6) Mammography.--The term ``mammography'' means 
        radiography of the breast.
            (7) Survey.--The term ``survey'' means an onsite 
        physics consultation and evaluation performed by a 
        medical physicist as described in subsection (f)(1)(E).
            (8) Review physician.--The term ``review 
        physician'' means a physician as prescribed by the 
        Secretary under subsection (f )(1)(D) who meets such 
        additional requirements as may be established by an 
        accreditation body under subsection (e) and approved by 
        the Secretary to review clinical images under 
        subsection (e)(1)(B)(i) on behalf of the accreditation 
        body.
    (b) Certificate Requirement.--
            (1) Certificate.--No facility may conduct an 
        examination or procedure described in paragraph (2) 
        involving mammography after October 1, 1994, unless the 
        facility obtains--
                    (A) a certificate or a temporary renewal 
                certificate--
                            (i) that is issued, and, if 
                        applicable, renewed, by the Secretary 
                        in accordance with paragraphs \1\ (1) 
                        or (2) of subsection (c);
---------------------------------------------------------------------------
    \1\ So in law. Probably should be ``paragraph''. See section 
2(1)(A)(ii) of Public Law 108-365 (118 Stat. 1738).
---------------------------------------------------------------------------
                            (ii) that is applicable to the 
                        examination or procedure to be 
                        conducted; and
                            (iii) that is displayed prominently 
                        in such facility; or
                    (B) a provisional certificate or a limited 
                provisional certificate--
                            (i) that is issued by the Secretary 
                        in accordance with paragraphs (3) and 
                        (4) of subsection (c);
                            (ii) that is applicable to the 
                        examination or procedure to be 
                        conducted; and
                            (iii) that is displayed prominently 
                        in such facility.
        The reference to a certificate in this section includes 
        a temporary renewal certificate, provisional 
        certificate, or a \2\ limited provisional certificate.
---------------------------------------------------------------------------
    \2\ So in law. The article ``a'' appears before both ``temporary 
renewal certificate'' and ``limited provisional certificate''. See 
section 2(1)(C) of Public Law 108-365 (118 Stat. 1738).
---------------------------------------------------------------------------
            (2) Examination or procedure.--A facility shall 
        obtain a certificate in order to--
                    (A) operate radiological equipment that is 
                used to image the breast;
                    (B) provide for the interpretation of a 
                mammogram produced by such equipment at the 
                facility or under arrangements with a qualified 
                individual at a facility different from where 
                the mammography examination is performed; and
                    (C) provide for the processing of film 
                produced by such equipment at the facility or 
                under arrangements with a qualified individual 
                at a facility different from where the 
                mammography examination is performed.
    (c) Issuance and Renewal of Certificates.--
            (1) In general.--The Secretary may issue or renew a 
        certificate for a facility if the person or agent 
        described in subsection (d)(1)(A) meets the applicable 
        requirements of subsection (d)(1) with respect to the 
        facility. The Secretary may issue or renew a 
        certificate under this paragraph for not more than 3 
        years.
            (2) Temporary renewal certificate.--The Secretary 
        may issue a temporary renewal certificate, for a period 
        of not to exceed 45 days, to a facility seeking 
        reaccreditation if the accreditation body has issued an 
        accreditation extension, for a period of not to exceed 
        45 days, for any of the following:
                    (A) The facility has submitted the required 
                materials to the accreditation body within the 
                established time frames for the submission of 
                such materials but the accreditation body is 
                unable to complete the reaccreditation process 
                before the certification expires.
                    (B) The facility has acquired additional or 
                replacement equipment, or has had significant 
                personnel changes or other unforeseen 
                situations that have caused the facility to be 
                unable to meet reaccreditation timeframes, but 
                in the opinion of the accreditation body have 
                not compromised the quality of mammography.
            (3) Limited provisional certificate.--The Secretary 
        may, upon the request of an accreditation body, issue a 
        limited provisional certificate to an entity to enable 
        the entity to conduct examinations for educational 
        purposes while an onsite visit from an accreditation 
        body is in progress. Such certificate shall be valid 
        only during the time the site visit team from the 
        accreditation body is physically in the facility, and 
        in no case shall be valid for longer than 72 hours. The 
        issuance of a certificate under this paragraph, shall 
        not preclude the entity from qualifying for a 
        provisional certificate under paragraph (4).
            (4) Provisional certificate.--The Secretary may 
        issue a provisional certificate for an entity to enable 
        the entity to qualify as a facility. The applicant for 
        a provisional certificate shall meet the requirements 
        of subsection (d)(1), except providing information 
        required by clauses (iii) and (iv) of subsection 
        (d)(1)(A). A provisional certificate may be in effect 
        no longer than 6 months from the date it is issued, 
        except that it may be extended once for a period of not 
        more than 90 days if the owner, lessor, or agent of the 
        facility demonstrates to the Secretary that without 
        such extension access to mammography in the geographic 
        area served by the facility would be significantly 
        reduced and if the owner, lessor, or agent of the 
        facility will describe in a report to the Secretary 
        steps that will be taken to qualify the facility for 
        certification under subsection (b)(1).
    (d) Application for Certificate.--
            (1) Submission.--The Secretary may issue or renew a 
        certificate for a facility if--
                    (A) the person who owns or leases the 
                facility or an authorized agent of the person, 
                submits to the Secretary, in such form and 
                manner as the Secretary shall prescribe, an 
                application that contains at a minimum--
                            (i) a description of the 
                        manufacturer, model, and type of each 
                        x-ray machine, image receptor, and 
                        processor operated in the performance 
                        of mammography by the facility;
                            (ii) a description of the 
                        procedures currently used to provide 
                        mammography at the facility, 
                        including--
                                    (I) the types of procedures 
                                performed and the number of 
                                such procedures performed in 
                                the prior 12 months;
                                    (II) the methodologies for 
                                mammography; and
                                    (III) the names and 
                                qualifications (educational 
                                background, training, and 
                                experience) of the personnel 
                                performing mammography and the 
                                physicians reading and 
                                interpreting the results from 
                                the procedures;
                            (iii) proof of on-site survey by a 
                        qualified medical physicist as 
                        described in subsection (f)(1)(E); and
                            (iv) proof of accreditation in such 
                        manner as the Secretary shall 
                        prescribe; and
                    (B) the person or agent submits to the 
                Secretary--
                            (i) a satisfactory assurance that 
                        the facility will be operated in 
                        accordance with standards established 
                        by the Secretary under subsection (f) 
                        to assure the safety and accuracy of 
                        mammography;
                            (ii) a satisfactory assurance that 
                        the facility will--
                                    (I) permit inspections 
                                under subsection (g);
                                    (II) make such records and 
                                information available, and 
                                submit such reports, to the 
                                Secretary as the Secretary may 
                                require; and
                                    (III) update the 
                                information submitted under 
                                subparagraph (A) or assurances 
                                submitted under this 
                                subparagraph on a timely basis 
                                as required by the Secretary; 
                                and
                            (iii) such other information as the 
                        Secretary may require.
        An applicant shall not be required to provide in an 
        application under subparagraph (A) any information 
        which the applicant has supplied to the accreditation 
        body which accredited the applicant, except as required 
        by the Secretary.
            (2) Appeal.--If the Secretary denies an application 
        for the certification of a facility submitted under 
        paragraph (1)(A), the Secretary shall provide the owner 
        or lessor of the facility or the agent of the owner or 
        lessor who submitted such application--
                    (A) a statement of the grounds on which the 
                denial is based, and
                    (B) an opportunity for an appeal in 
                accordance with the procedures set forth in 
                regulations of the Secretary published at part 
                498 of title 42, Code of Federal Regulations.
            (3) Effect of denial.--If the application for the 
        certification of a facility is denied, the facility may 
        not operate unless the denial of the application is 
        overturned at the conclusion of the administrative 
        appeals process provided in the regulations referred to 
        in paragraph (2)(B).
    (e) Accreditation.--
            (1) Approval of accreditation bodies.--
                    (A) In general.--The Secretary may approve 
                a private nonprofit organization or State 
                agency to accredit facilities for purposes of 
                subsection (d)(1)(A)(iv) if the accreditation 
                body meets the standards for accreditation 
                established by the Secretary as described in 
                subparagraph (B) and provides the assurances 
                required by subparagraph (C).
                    (B) Standards.--The Secretary shall 
                establish standards for accreditation bodies, 
                including--
                            (i) standards that require an 
                        accreditation body to perform--
                                    (I) a review of clinical 
                                images from each facility 
                                accredited by such body not 
                                less often than every 3 years 
                                which review will be made by 
                                qualified review physicians; 
                                and
                                    (II) a review of a random 
                                sample of clinical images from 
                                such facilities in each 3-year 
                                period beginning October 1, 
                                1994, which review will be made 
                                by qualified review physicians;
                            (ii) standards that prohibit 
                        individuals conducting the reviews 
                        described in clause (i) from 
                        maintaining any relationship to the 
                        facility undergoing review which would 
                        constitute a conflict of interest;
                            (iii) standards that limit the 
                        imposition of fees for accreditation to 
                        reasonable amounts;
                            (iv) standards that require as a 
                        condition of accreditation that each 
                        facility undergo a survey at least 
                        annually by a medical physicist as 
                        described in subsection (f)(1)(E) to 
                        ensure that the facility meets the 
                        standards described in subparagraphs 
                        (A) and (B) of subsection (f)(1);
                            (v) standards that require 
                        monitoring and evaluation of such 
                        survey, as prescribed by the Secretary;
                            (vi) standards that are equal to 
                        standards established under subsection 
                        (f) which are relevant to accreditation 
                        as determined by the Secretary; and
                            (vii) such additional standards as 
                        the Secretary may require.
                    (C) Assurances.--The accrediting body shall 
                provide the Secretary satisfactory assurances 
                that the body will--
                            (i) comply with the standards as 
                        described in subparagraph (B);
                            (ii) comply with the requirements 
                        described in paragraph (4);
                            (iii) submit to the Secretary the 
                        name of any facility for which the 
                        accreditation body denies, suspends, or 
                        revokes accreditation;
                            (iv) notify the Secretary in a 
                        timely manner before the accreditation 
                        body changes the standards of the body;
                            (v) notify each facility accredited 
                        by the accreditation body if the 
                        Secretary withdraws approval of the 
                        accreditation body under paragraph (2) 
                        in a timely manner; and
                            (vi) provide such other additional 
                        information as the Secretary may 
                        require.
                    (D) Regulations.--Not later than 9 months 
                after the date of the enactment of this 
                section, the Secretary shall promulgate 
                regulations under which the Secretary may 
                approve an accreditation body.
            (2) Withdrawal of approval.--
                    (A) In general.--The Secretary shall 
                promulgate regulations under which the 
                Secretary may withdraw the approval of an 
                accreditation body if the Secretary determines 
                that the accreditation body does not meet the 
                standards under subparagraph (B) of paragraph 
                (1), the requirements of clauses (i) through 
                (vi) of subparagraph (C) of paragraph (1), or 
                the requirements of paragraph (4).
                    (B) Effect of withdrawal.--If the Secretary 
                withdraws the approval of an accreditation body 
                under subparagraph (A), the certificate of any 
                facility accredited by the body shall continue 
                in effect until the expiration of a reasonable 
                period, as determined by the Secretary, for 
                such facility to obtain another accreditation.
            (3) Accreditation.--To be accredited by an approved 
        accreditation body a facility shall meet--
                    (A) the standards described in paragraph 
                (1)(B) which the Secretary determines are 
                applicable to the facility, and
                    (B) such other standards which the 
                accreditation body may require.
            (4) Compliance.--To ensure that facilities 
        accredited by an accreditation body will continue to 
        meet the standards of the accreditation body, the 
        accreditation body shall--
                    (A) make onsite visits on an annual basis 
                of a sufficient number of the facilities 
                accredited by the body to allow a reasonable 
                estimate of the performance of the body; and
                    (B) take such additional measures as the 
                Secretary determines to be appropriate.
        Visits made under subparagraph (A) shall be made after 
        providing such notice as the Secretary may require.
            (5) Revocation of accreditation.--If an 
        accreditation body revokes the accreditation of a 
        facility, the certificate of the facility shall 
        continue in effect until such time as may be determined 
        by the Secretary.
            (6) Evaluation and report.--
                    (A) Evaluation.--The Secretary shall 
                evaluate annually the performance of each 
                approved accreditation body by--
                            (i) inspecting under subsection 
                        (g)(2) a sufficient number of the 
                        facilities accredited by the body to 
                        allow a reasonable estimate of the 
                        performance of the body; and
                            (ii) such additional means as the 
                        Secretary determines to be appropriate.
                    (B) Report.--The Secretary shall annually 
                prepare and submit to the Committee on Labor 
                and Human Resources of the Senate and the 
                Committee on Energy and Commerce of the House 
                of Representatives a report that describes the 
                results of the evaluation conducted in 
                accordance with subparagraph (A).
    (f) Quality Standards.--
            (1) In general.--The standards referred to in 
        subsection (d)(1)(B)(i) are standards established by 
        the Secretary which include--
                    (A) standards that require establishment 
                and maintenance of a quality assurance and 
                quality control program at each facility that 
                is adequate and appropriate to ensure the 
                reliability, clarity, and accuracy of 
                interpretation of mammograms and standards for 
                appropriate radiation dose;
                    (B) standards that require use of 
                radiological equipment specifically designed 
                for mammography, including radiologic standards 
                and standards for other equipment and materials 
                used in conjunction with such equipment;
                    (C) a requirement that personnel who 
                perform mammography--
                            (i)(I) be licensed by a State to 
                        perform radiological procedures; or
                            (II) be certified as qualified to 
                        perform radiological procedures by an 
                        organization described in paragraph 
                        (2)(A); and
                            (ii) during the 2-year period 
                        beginning October 1, 1994, meet 
                        training standards for personnel who 
                        perform mammography or meet experience 
                        requirements which shall at a minimum 
                        include 1 year of experience in the 
                        performance of mammography; and
                            (iii) upon the expiration of such 
                        2-year period meet minimum training 
                        standards for personnel who perform 
                        mammograms;
                    (D) a requirement that mammograms be 
                interpreted by a physician who is certified as 
                qualified to interpret radiological procedures, 
                including mammography--
                            (i)(I) by a board described in 
                        paragraph (2)(B); or
                            (II) by a program that complies 
                        with the standards described in 
                        paragraph (2)(C); and
                            (ii) who meets training and 
                        continuing medical education 
                        requirements as established by the 
                        Secretary;
                    (E) a requirement that individuals who 
                survey mammography facilities be medical 
                physicists--
                            (i) licensed or approved by a State 
                        to perform such surveys, reviews, or 
                        inspections for mammography facilities;
                            (ii) certified in diagnostic 
                        radiological physics or certified as 
                        qualified to perform such surveys by a 
                        board as described in paragraph (2)(D); 
                        or
                            (iii) in the first 5 years after 
                        the date of the enactment of this 
                        section, who meet other criteria 
                        established by the Secretary which are 
                        comparable to the criteria described in 
                        clause (i) or (ii);
                    (F) a requirement that a medical physicist 
                who is qualified in mammography as described in 
                subparagraph (E) survey mammography equipment 
                and oversee quality assurance practices at each 
                facility;
                    (G) a requirement that--
                            (i) a facility that performs any 
                        mammogram--
                                    (I) except as provided in 
                                subclause (II), maintain the 
                                mammogram in the permanent 
                                medical records of the patient 
                                for a period of not less than 5 
                                years, or not less than 10 
                                years if no subsequent 
                                mammograms of such patient are 
                                performed at the facility, or 
                                longer if mandated by State 
                                law; and
                                    (II) upon the request of or 
                                on behalf of the patient, 
                                transfer the mammogram to a 
                                medical institution, to a 
                                physician of the patient, or to 
                                the patient directly; and
                            (ii)(I) a facility must assure the 
                        preparation of a written report of the 
                        results of any mammography examination 
                        signed by the interpreting physician;
                            (II) such written report shall be 
                        provided to the patient's physicians 
                        (if any);
                            (III) if such a physician is not 
                        available or if there is no such 
                        physician, the written report shall be 
                        sent directly to the patient; and
                            (IV) whether or not such a 
                        physician is available or there is no 
                        such physician, a summary of the 
                        written report shall be sent directly 
                        to the patient in terms easily 
                        understood by a lay person; and
                    (H) standards relating to special 
                techniques for mammography of patients with 
                breast implants.
        Subparagraph (G) shall not be construed to limit a 
        patient's access to the patient's medical records.
            (2) Certification of personnel.--The Secretary 
        shall by regulation--
                    (A) specify organizations eligible to 
                certify individuals to perform radiological 
                procedures as required by paragraph (1)(C);
                    (B) specify boards eligible to certify 
                physicians to interpret radiological 
                procedures, including mammography, as required 
                by paragraph (1)(D);
                    (C) establish standards for a program to 
                certify physicians described in paragraph 
                (1)(D); and
                    (D) specify boards eligible to certify 
                medical physicists who are qualified to survey 
                mammography equipment and to oversee quality 
                assurance practices at mammography facilities.
    (g) Inspections.--
            (1) Annual inspections.--
                    (A) In general.--The Secretary may enter 
                and inspect facilities to determine compliance 
                with the certification requirements under 
                subsection (b) and the standards established 
                under subsection (f). The Secretary shall, if 
                feasible, delegate to a State or local agency 
                the authority to make such inspections.
                    (B) Identification.--The Secretary, or 
                State or local agency acting on behalf of the 
                Secretary, may conduct inspections only on 
                presenting identification to the owner, 
                operator, or agent in charge of the facility to 
                be inspected.
                    (C) Scope of inspection.--In conducting 
                inspections, the Secretary or State or local 
                agency acting on behalf of the Secretary--
                            (i) shall have access to all 
                        equipment, materials, records, and 
                        information that the Secretary or State 
                        or local agency considers necessary to 
                        determine whether the facility is being 
                        operated in accordance with this 
                        section; and
                            (ii) may copy, or require the 
                        facility to submit to the Secretary or 
                        the State or local agency, any of the 
                        materials, records, or information.
                    (D) Qualifications of inspectors.--
                Qualified individuals, as determined by the 
                Secretary, shall conduct all inspections. The 
                Secretary may request that a State or local 
                agency acting on behalf of the Secretary 
                designate a qualified officer or employee to 
                conduct the inspections, or designate a 
                qualified Federal officer or employee to 
                conduct inspections. The Secretary shall 
                establish minimum qualifications and 
                appropriate training for inspectors and 
                criteria for certification of inspectors in 
                order to inspect facilities for compliance with 
                subsection (f).
                    (E) Frequency.--The Secretary or State or 
                local agency acting on behalf of the Secretary 
                shall conduct inspections under this paragraph 
                of each facility not less often than annually, 
                subject to paragraph (6).
                    (F) Records and annual reports.--The 
                Secretary or a State or local agency acting on 
                behalf of the Secretary which is responsible 
                for inspecting mammography facilities shall 
                maintain records of annual inspections required 
                under this paragraph for a period as prescribed 
                by the Secretary. Such a State or local agency 
                shall annually prepare and submit to the 
                Secretary a report concerning the inspections 
                carried out under this paragraph. Such reports 
                shall include a description of the facilities 
                inspected and the results of such inspections.
            (2) Inspection of accredited facilities.--The 
        Secretary shall inspect annually a sufficient number of 
        the facilities accredited by an accreditation body to 
        provide the Secretary with a reasonable estimate of the 
        performance of such body.
            (3) Inspection of facilities inspected by state or 
        local agencies.--The Secretary shall inspect annually 
        facilities inspected by State or local agencies acting 
        on behalf of the Secretary to assure a reasonable 
        performance by such State or local agencies.
            (4) Timing.--The Secretary, or State or local 
        agency, may conduct inspections under paragraphs (1), 
        (2), and (3), during regular business hours or at a 
        mutually agreeable time and after providing such notice 
        as the Secretary may prescribe, except that the 
        Secretary may waive such requirements if the continued 
        performance of mammography at such facility threatens 
        the public health.
            (5) Limited reinspection.--Nothing in this section 
        limits the authority of the Secretary to conduct 
        limited reinspections of facilities found not to be in 
        compliance with this section.
            (6) Demonstration program.--
                    (A) In general.--The Secretary may 
                establish a demonstration program under which 
                inspections under paragraph (1) of selected 
                facilities are conducted less frequently by the 
                Secretary (or as applicable, by State or local 
                agencies acting on behalf of the Secretary) 
                than the interval specified in subparagraph (E) 
                of such paragraph.
                    (B) Requirements.--Any demonstration 
                program under subparagraph (A) shall be carried 
                out in accordance with the following:
                            (i) The program may not be 
                        implemented before April 1, 2001. 
                        Preparations for the program may be 
                        carried out prior to such date.
                            (ii) In carrying out the program, 
                        the Secretary may not select a facility 
                        for inclusion in the program unless the 
                        facility is substantially free of 
                        incidents of noncompliance with the 
                        standards under subsection (f ). The 
                        Secretary may at any time provide that 
                        a facility will no longer be included 
                        in the program.
                            (iii) The number of facilities 
                        selected for inclusion in the program 
                        shall be sufficient to provide a 
                        statistically significant sample, 
                        subject to compliance with clause (ii).
                            (iv) Facilities that are selected 
                        for inclusion in the program shall be 
                        inspected at such intervals as the 
                        Secretary determines will reasonably 
                        ensure that the facilities are 
                        maintaining compliance with such 
                        standards.
    (h) Sanctions.--
            (1) In general.--In order to promote voluntary 
        compliance with this section, the Secretary may, in 
        lieu of taking the actions authorized by subsection 
        (i), impose one or more of the following sanctions:
                    (A) Directed plans of correction which 
                afford a facility an opportunity to correct 
                violations in a timely manner.
                    (B) Payment for the cost of onsite 
                monitoring.
            (2) Patient information.--If the Secretary 
        determines that the quality of mammography performed by 
        a facility (whether or not certified pursuant to 
        subsection (c)) was so inconsistent with the quality 
        standards established pursuant to subsection (f ) as to 
        present a significant risk to individual or public 
        health, the Secretary may require such facility to 
        notify patients who received mammograms at such 
        facility, and their referring physicians, of the 
        deficiencies presenting such risk, the potential harm 
        resulting, appropriate remedial measures, and such 
        other relevant information as the Secretary may 
        require.
            (3) Civil money penalties.--The Secretary may 
        assess civil money penalties in an amount not to exceed 
        $10,000 for--
                    (A) failure to obtain a certificate as 
                required by subsection (b),
                    (B) each failure by a facility to 
                substantially comply with, or each day on which 
                a facility fails to substantially comply with, 
                the standards established under subsection (f) 
                or the requirements described in subclauses (I) 
                through (III) of subsection (d)(1)(B)(ii),
                    (C) each failure to notify a patient of 
                risk as required by the Secretary pursuant to 
                paragraph (2), and
                    (D) each violation, or for each aiding and 
                abetting in a violation of, any provision of, 
                or regulation promulgated under, this section 
                by an owner, operator, or any employee of a 
                facility required to have a certificate.
            (4) Procedures.--The Secretary shall develop and 
        implement procedures with respect to when and how each 
        of the sanctions is to be imposed under paragraphs (1) 
        through (3). Such procedures shall provide for notice 
        to the owner or operator of the facility and a 
        reasonable opportunity for the owner or operator to 
        respond to the proposed sanctions and appropriate 
        procedures for appealing determinations relating to the 
        imposition of sanctions.
    (i) Suspension and Revocation.--
            (1) In general.--The certificate of a facility 
        issued under subsection (c) may be suspended or revoked 
        if the Secretary finds, after providing, except as 
        provided in paragraph (2), reasonable notice and an 
        opportunity for a hearing to the owner or operator of 
        the facility, that the owner, operator, or any employee 
        of the facility--
                    (A) has been guilty of misrepresentation in 
                obtaining the certificate;
                    (B) has failed to comply with the 
                requirements of subsection (d)(1)(B)(ii)(III) 
                or the standards established by the Secretary 
                under subsection (f);
                    (C) has failed to comply with reasonable 
                requests of the Secretary (or of an 
                accreditation body approved pursuant to 
                subsection (e)) for any record, information, 
                report, or material that the Secretary (or such 
                accreditation body or State carrying out 
                certification program requirements pursuant to 
                subsection (q)) concludes is necessary to 
                determine the continued eligibility of the 
                facility for a certificate or continued 
                compliance with the standards established under 
                subsection (f);
                    (D) has refused a reasonable request of the 
                Secretary, any Federal officer or employee duly 
                designated by the Secretary, or any State or 
                local officer or employee duly designated by 
                the State or local agency, for permission to 
                inspect the facility or the operations and 
                pertinent records of the facility in accordance 
                with subsection (g);
                    (E) has violated or aided and abetted in 
                the violation of any provision of, or 
                regulation promulgated under, this section; or
                    (F) has failed to comply with a sanction 
                imposed under subsection (h).
            (2) Action before a hearing.--
                    (A) In general.--The Secretary may suspend 
                the certificate of the facility before holding 
                a hearing required by paragraph (1) if the 
                Secretary has reason to believe that the 
                circumstance of the case will support one or 
                more of the findings described in paragraph (1) 
                and that--
                            (i) the failure or violation was 
                        intentional; or
                            (ii) the failure or violation 
                        presents a serious risk to human 
                        health.
                    (B) Hearing.--If the Secretary suspends a 
                certificate under subparagraph (A), the 
                Secretary shall provide an opportunity for a 
                hearing to the owner or operator of the 
                facility not later than 60 days from the 
                effective date of the suspension. The 
                suspension shall remain in effect until the 
                decision of the Secretary made after the 
                hearing.
            (3) Ineligibility to own or operate facilities 
        after revocation.--If the Secretary revokes the 
        certificate of a facility on the basis of an act 
        described in paragraph (1), no person who owned or 
        operated the facility at the time of the act may, 
        within 2 years of the revocation of the certificate, 
        own or operate a facility that requires a certificate 
        under this section.
    (j) Injunctions.--If the Secretary determines that--
            (1) continuation of any activity related to the 
        provision of mammography by a facility would constitute 
        a serious risk to human health, the Secretary may bring 
        suit in the district court of the United States for the 
        district in which the facility is situated to enjoin 
        continuation of the activity; and
            (2) a facility is operating without a certificate 
        as required by subsection (b), the Secretary may bring 
        suit in the district court of the United States for the 
        district in which the facility is situated to enjoin 
        the operation of the facility.
Upon a proper showing, the district court shall grant a 
temporary injunction or restraining order against continuation 
of the activity or against operation of a facility, as the case 
may be, without requiring the Secretary to post a bond, pending 
issuance of a final order under this subsection.
    (k) Judicial Review.--
            (1) Petition.--If the Secretary imposes a sanction 
        on a facility under subsection (h) or suspends or 
        revokes the certificate of a facility under subsection 
        (i), the owner or operator of the facility may, not 
        later than 60 days after the date the action of the 
        Secretary becomes final, file a petition with the 
        United States court of appeals for the circuit in which 
        the facility is situated for judicial review of the 
        action. As soon as practicable after receipt of the 
        petition, the clerk of the court shall transmit a copy 
        of the petition to the Secretary or other officer 
        designated by the Secretary. As soon as practicable 
        after receipt of the copy, the Secretary shall file in 
        the court the record on which the action of the 
        Secretary is based, as provided in section 2112 of 
        title 28, United States Code.
            (2) Additional evidence.--If the petitioner applies 
        to the court for leave to adduce additional evidence, 
        and shows to the satisfaction of the court that the 
        additional evidence is material and that there were 
        reasonable grounds for the failure to adduce such 
        evidence in the proceeding before the Secretary, the 
        court may order the additional evidence (and evidence 
        in rebuttal of the additional evidence) to be taken 
        before the Secretary, and to be adduced upon the 
        hearing in such manner and upon such terms and 
        conditions as the court may determine to be proper. The 
        Secretary may modify the findings of the Secretary as 
        to the facts, or make new findings, by reason of the 
        additional evidence so taken, and the Secretary shall 
        file the modified or new findings, and the 
        recommendations of the Secretary, if any, for the 
        modification or setting aside of the original action of 
        the Secretary with the return of the additional 
        evidence.
            (3) Judgment of court.--Upon the filing of the 
        petition referred to in paragraph (1), the court shall 
        have jurisdiction to affirm the action, or to set the 
        action aside in whole or in part, temporarily or 
        permanently. The findings of the Secretary as to the 
        facts, if supported by substantial evidence, shall be 
        conclusive.
            (4) Finality of judgment.--The judgment of the 
        court affirming or setting aside, in whole or in part, 
        any action of the Secretary shall be final, subject to 
        review by the Supreme Court of the United States upon 
        certiorari or certification, as provided in section 
        1254 of title 28, United States Code.
    (l) Information.--
            (1) In general.--Not later than October 1, 1996, 
        and annually thereafter, the Secretary shall compile 
        and make available to physicians and the general public 
        information that the Secretary determines is useful in 
        evaluating the performance of facilities, including a 
        list of facilities--
                    (A) that have been convicted under Federal 
                or State laws relating to fraud and abuse, 
                false billings, or kickbacks;
                    (B) that have been subject to sanctions 
                under subsection (h), together with a statement 
                of the reasons for the sanctions;
                    (C) that have had certificates revoked or 
                suspended under subsection (i), together with a 
                statement of the reasons for the revocation or 
                suspension;
                    (D) against which the Secretary has taken 
                action under subsection (j), together with a 
                statement of the reasons for the action;
                    (E) whose accreditation has been revoked, 
                together with a statement of the reasons of the 
                revocation;
                    (F) against which a State has taken adverse 
                action; and
                    (G) that meets such other measures of 
                performance as the Secretary may develop.
            (2) Date.--The information to be compiled under 
        paragraph (1) shall be information for the calendar 
        year preceding the date the information is to be made 
        available to the public.
            (3) Explanatory information.--The information to be 
        compiled under paragraph (1) shall be accompanied by 
        such explanatory information as may be appropriate to 
        assist in the interpretation of the information 
        compiled under such paragraph.
    (m) State Laws.--Nothing in this section shall be construed 
to limit the authority of any State to enact and enforce laws 
relating to the matters covered by this section that are at 
least as stringent as this section or the regulations issued 
under this section.
    (n) National Advisory Committee.--
            (1) Establishment.--In carrying out this section, 
        the Secretary shall establish an advisory committee to 
        be known as the National Mammography Quality Assurance 
        Advisory Committee (hereafter in this subsection 
        referred to as the ``Advisory Committee'').
            (2) Composition.--The Advisory Committee shall be 
        composed of not fewer than 13, nor more than 19 
        individuals, who are not officers or employees of the 
        Federal Government. The Secretary shall make 
        appointments to the Advisory Committee from among--
                    (A) physicians,
                    (B) practitioners, and
                    (C) other health professionals,
        whose clinical practice, research specialization, or 
        professional expertise include a significant focus on 
        mammography. The Secretary shall appoint at least 4 
        individuals from among national breast cancer or 
        consumer health organizations with expertise in 
        mammography, at least 2 industry representatives with 
        expertise in mammography equipment, and at least 2 
        practicing physicians who provide mammography services.
            (3) Functions and duties.--The Advisory Committee 
        shall--
                    (A) advise the Secretary on appropriate 
                quality standards and regulations for 
                mammography facilities;
                    (B) advise the Secretary on appropriate 
                standards and regulations for accreditation 
                bodies;
                    (C) advise the Secretary in the development 
                of regulations with respect to sanctions;
                    (D) assist in developing procedures for 
                monitoring compliance with standards under 
                subsection (f);
                    (E) make recommendations and assist in the 
                establishment of a mechanism to investigate 
                consumer complaints;
                    (F) report on new developments concerning 
                breast imaging that should be considered in the 
                oversight of mammography facilities;
                    (G) determine whether there exists a 
                shortage of mammography facilities in rural and 
                health professional shortage areas and 
                determine the effects of personnel or other 
                requirements of subsection (f) on access to the 
                services of such facilities in such areas;
                    (H) determine whether there will exist a 
                sufficient number of medical physicists after 
                October 1, 1999, to assure compliance with the 
                requirements of subsection (f)(1)(E);
                    (I) determine the costs and benefits of 
                compliance with the requirements of this 
                section (including the requirements of 
                regulations promulgated under this section); 
                and
                    (J) perform other activities that the 
                Secretary may require.
        The Advisory Committee shall report the findings made 
        under subparagraphs (G) and (I) to the Secretary and 
        the Congress no later than October 1, 1993.
            (4) Meetings.--The Advisory Committee shall meet 
        not less than quarterly for the first 3 years of the 
        program and thereafter, at least annually.
            (5) Chairperson.--The Secretary shall appoint a 
        chairperson of the Advisory Committee.
    (o) Consultations.--In carrying out this section, the 
Secretary shall consult with appropriate Federal agencies 
within the Department of Health and Human Services for the 
purposes of developing standards, regulations, evaluations, and 
procedures for compliance and oversight.
    (p) Breast Cancer Screening Surveillance Research Grants.--
            (1) Research.--
                    (A) Grants.--The Secretary shall award 
                grants to such entities as the Secretary may 
                determine to be appropriate to establish 
                surveillance systems in selected geographic 
                areas to provide data to evaluate the 
                functioning and effectiveness of breast cancer 
                screening programs in the United States, 
                including assessments of participation rates in 
                screening mammography, diagnostic procedures, 
                incidence of breast cancer, mode of detection 
                (mammography screening or other methods), 
                outcome and follow up information, and such 
                related epidemiologic analyses that may improve 
                early cancer detection and contribute to 
                reduction in breast cancer mortality. Grants 
                may be awarded for further research on breast 
                cancer surveillance systems upon the 
                Secretary's review of the evaluation of the 
                program.
                    (B) Use of funds.--Grants awarded under 
                subparagraph (A) may be used--
                            (i) to study--
                                    (I) methods to link 
                                mammography and clinical breast 
                                examination records with 
                                population-based cancer 
                                registry data;
                                    (II) methods to provide 
                                diagnostic outcome data, or 
                                facilitate the communication of 
                                diagnostic outcome data, to 
                                radiology facilities for 
                                purposes of evaluating patterns 
                                of mammography interpretation; 
                                and
                                    (III) mechanisms for 
                                limiting access and maintaining 
                                confidentiality of all stored 
                                data; and
                            (ii) to conduct pilot testing of 
                        the methods and mechanisms described in 
                        subclauses (I), (II), and (III) of 
                        clause (i) on a limited basis.
                    (C) Grant application.--To be eligible to 
                receive funds under this paragraph, an entity 
                shall submit an application to the Secretary at 
                such time, in such manner, and containing such 
                information as the Secretary may require.
                    (D) Report.--A recipient of a grant under 
                this paragraph shall submit a report to the 
                Secretary containing the results of the study 
                and testing conducted under clauses (i) and 
                (ii) of subparagraph (B), along with 
                recommendations for methods of establishing a 
                breast cancer screening surveillance system.
            (2) Establishment.--The Secretary shall establish a 
        breast cancer screening surveillance system based on 
        the recommendations contained in the report described 
        in paragraph (1)(D).
            (3) Standards and procedures.--The Secretary shall 
        establish standards and procedures for the operation of 
        the breast cancer screening surveillance system, 
        including procedures to maintain confidentiality of 
        patient records.
            (4) Information.--The Secretary shall recruit 
        facilities to provide to the breast cancer screening 
        surveillance system relevant data that could help in 
        the research of the causes, characteristics, and 
        prevalence of, and potential treatments for, breast 
        cancer and benign breast conditions, if the information 
        may be disclosed under section 552 of title 5, United 
        States Code.
    (q) State Program.--
            (1) In general.--The Secretary may, upon 
        application, authorize a State--
                    (A) to carry out, subject to paragraph (2), 
                the certification program requirements under 
                subsections (b), (c), (d), (g)(1), (h), (i), 
                and (j) (including the requirements under 
                regulations promulgated pursuant to such 
                subsections), and
                    (B) to implement the standards established 
                by the Secretary under subsection (f),
        with respect to mammography facilities operating within 
        the State.
            (2) Approval.-- The Secretary may approve an 
        application under paragraph (1) if the Secretary 
        determines that--
                    (A) the State has enacted laws and issued 
                regulations relating to mammography facilities 
                which are the requirements of this section 
                (including the requirements under regulations 
                promulgated pursuant to such subsections), and
                    (B) the State has provided satisfactory 
                assurances that the State--
                            (i) has the legal authority and 
                        qualified personnel necessary to 
                        enforce the requirements of and the 
                        regulations promulgated pursuant to 
                        this section (including the 
                        requirements under regulations 
                        promulgated pursuant to such 
                        subsections),
                            (ii) will devote adequate funds to 
                        the administration and enforcement of 
                        such requirements, and
                            (iii) will provide the Secretary 
                        with such information and reports as 
                        the Secretary may require.
            (3) Authority of Secretary.--In a State with an 
        approved application--
                    (A) the Secretary shall carry out the 
                Secretary's functions under subsections (e) and 
                (f);
                    (B) the Secretary may take action under 
                subsections (h), (i), and (j); and
                    (C) the Secretary shall conduct oversight 
                functions under subsections (g)(2) and (g)(3).
            (4) Withdrawal of approval.--
                    (A) In general.--The Secretary may, after 
                providing notice and opportunity for corrective 
                action, withdraw the approval of a State's 
                authority under paragraph (1) if the Secretary 
                determines that the State does not meet the 
                requirements of such paragraph. The Secretary 
                shall promulgate regulations for the 
                implementation of this subparagraph.
                    (B) Effect of withdrawal.--If the Secretary 
                withdraws the approval of a State under 
                subparagraph (A), the certificate of any 
                facility certified by the State shall continue 
                in effect until the expiration of a reasonable 
                period, as determined by the Secretary, for 
                such facility to obtain certification by the 
                Secretary.
    (r) Funding.--
            (1) Fees.--
                    (A) In general.--The Secretary shall, in 
                accordance with this paragraph assess and 
                collect fees from persons described in 
                subsection (d)(1)(A) (other than persons who 
                are governmental entities, as determined by the 
                Secretary) to cover the costs of inspections 
                conducted under subsection (g)(1) by the 
                Secretary or a State acting under a delegation 
                under subparagraph (A) of such subsection. Fees 
                may be assessed and collected under this 
                paragraph only in such manner as would result 
                in an aggregate amount of fees collected during 
                any fiscal year which equals the aggregate 
                amount of costs for such fiscal year for 
                inspections of facilities of such persons under 
                subsection (g)(1). A person's liability for 
                fees shall be reasonably based on the 
                proportion of the inspection costs which relate 
                to such person.
                    (B) Deposit and appropriations.--
                            (i) Deposit and availability.--Fees 
                        collected under subparagraph (A) shall 
                        be deposited as an offsetting 
                        collection to the appropriations for 
                        the Department of Health and Human 
                        Services as provided in appropriation 
                        Acts and shall remain available without 
                        fiscal year limitation.
                            (ii) Appropriations.--Fees 
                        collected under subparagraph (A) shall 
                        be collected and available only to the 
                        extent provided in advance in 
                        appropriation Acts.
            (2) Authorization of Appropriations.--There are 
        authorized to be appropriated to carry out this 
        section--
                    (A) to award research grants under 
                subsection (p), such sums as may be necessary 
                for each of the fiscal years 1993 through 2007; 
                and
                    (B) for the Secretary to carry out other 
                activities which are not supported by fees 
                authorized and collected under paragraph (1), 
                such sums as may be necessary for fiscal years 
                1993 through 2007.

                   Part G--Quarantine and Inspection

                    control of communicable diseases

    Sec. 361. [264] (a) The Surgeon General, with the approval 
of the Secretary is authorized to make and enforce such 
regulations as in his judgment are necessary to prevent the 
introduction, transmission, or spread of communicable diseases 
from foreign countries into the States or possessions, or from 
one State or possession into any other State or possession. For 
purposes of carrying out and enforcing such regulations, the 
Surgeon General may provide for such inspection, fumigation, 
disinfection, sanitation, pest extermination, destruction of 
animals or articles found to be so infected or contaminated as 
to be sources of dangerous infection to human beings, and other 
measures, as in his judgment may be necessary.
    (b) Regulations prescribed under this section shall not 
provide for the apprehension, detention, or conditional release 
of individuals except for the purpose of preventing the 
introduction, transmission, or spread of such communicable 
diseases as may be specified from time to time in Executive 
orders of the President upon the recommendation of the 
Secretary, in consultation with the Surgeon General, \1\.
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    \1\ The comma is so in law. See the amendment made by section 
142(a)(1) of Public Law 107-188 (116 Stat. 626).
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    (c) Except as provided in subsection (d), regulations 
prescribed under this section, insofar as they provide for the 
apprehension, detention, examination, or conditional release of 
individuals, shall be applicable only to individuals coming 
into a State or possession from a foreign country or a 
possession.
    (d)(1) Regulations prescribed under this section may 
provide for the apprehension and examination of any individual 
reasonably believed to be infected with a communicable disease 
in a qualifying stage and (A) to be moving or about to move 
from a State to another State; or (B) to be a probable source 
of infection to individuals who, while infected with such 
disease in a qualifying stage, will be moving from a State to 
another State. Such regulations may provide that if upon 
examination any such individual is found to be infected, he may 
be detained for such time and in such manner as may be 
reasonably necessary. For purposes of this subsection, the term 
``State'' includes, in addition to the several States, only the 
District of Columbia.
    (2) For purposes of this subsection, the term ``qualifying 
stage'', with respect to a communicable disease, means that 
such disease--
            (A) is in a communicable stage; or
            (B) is in a precommunicable stage, if the disease 
        would be likely to cause a public health emergency if 
        transmitted to other individuals.
    (e) Nothing in this section or section 363, or the 
regulations promulgated under such sections, may be construed 
as superseding any provision under State law (including 
regulations and including provisions established by political 
subdivisions of States), except to the extent that such a 
provision conflicts with an exercise of Federal authority under 
this section or section 363.

        suspension of entries and imports from designated places

    Sec. 362. [265] Whenever the Surgeon General determines 
that by reason of the existence of any communicable disease in 
a foreign country there is serious danger of the introduction 
of such disease into the United States, and that this danger is 
so increased by the introduction of persons or property from 
such country that a suspension of the right to introduce such 
persons and property is required in the interest of the public 
health, the Surgeon General, in accordance with regulations 
approved by the President, shall have the power to prohibit, in 
whole or in part, the introduction of persons and property from 
such countries or places as he shall designate in order to 
avert such danger, and for such period of time as he may deem 
necessary for such purpose.
                     special powers in time of war
    Sec. 363. \1\ [266] To protect the military and naval 
forces and war workers of the United States, in time of war, 
against any communicable disease specified in Executive orders 
as provided in subsection (b) of section 361, the Secretary, in 
consultation with the Surgeon General, is authorized to provide 
by regulations for the apprehension and examination, in time of 
war, of any individual reasonably believed (1) to be infected 
with such disease and (2) to be a probable source of infection 
to members of the armed forces of the United States or to 
individuals engaged in the production or transportation of 
arms, munitions, ships, food, clothing, or other supplies for 
the armed forces. Such regulations may provide that if upon 
examination any such individual is found to be so infected, he 
may be detained for such time and in such manner as may be 
reasonably necessary.
---------------------------------------------------------------------------
    \1\ Under section 3 of Public Law 239, 80th Congress, the date of 
July 25, 1947, is deemed, for purposes of this section, to be the date 
of termination of ``any state of war heretofore declared by the 
Congress''.
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                          quarantine stations

    Sec. 364. [267] (a) Except as provided in title II of the 
Act of June 15, 1917, as amended (U.S.C., 1940 edition, title 
50, secs. 191-194), \2\ the Surgeon General shall control, 
direct, and manage all United States quarantine stations, 
grounds, and anchorages, designate their boundaries, and 
designate the quarantine officers to be in charge thereof. With 
the approval of the President he shall from time to time select 
suitable sites for and establish such additional stations, 
grounds, and anchorages in the States and possessions of the 
United States as in his judgment are necessary to prevent the 
introduction of communicable diseases into the States and 
possessions of the United States.
---------------------------------------------------------------------------
    \2\ Now codified to sections 191, 192, 194, and 195 of title 50, 
United States Code.
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    (b) The Surgeon General shall establish the hours during 
which quarantine service shall be performed at each quarantine 
station, and, upon application by any interested party, may 
establish quarantine inspection during the twenty-four hours of 
the day, or any fraction thereof, at such quarantine stations 
as, in his opinion, require such extended service. He may 
restrict the performance of quarantine inspection to hours of 
daylight for such arriving vessels as cannot, in his opinion, 
be satisfactorily inspected during hours of darkness. No vessel 
shall be required to undergo quarantine inspection during the 
hours of darkness, unless the quarantine officer at such 
quarantine station shall deem an immediate inspection necessary 
to protect the public health. Uniformity shall not be required 
in the hours during which quarantine inspection may be obtained 
at the various ports of the United States.
    (c) The Surgeon General shall fix a reasonable rate of 
extra compensation for overtime services of employees of the 
United States Public Health Service, Foreign Quarantine 
Division, performing overtime duties including the operation of 
vessels, in connection with the inspection or quarantine 
treatment of persons (passengers and crews), conveyances, or 
goods arriving by land, water, or air in the United States or 
any place subject to the jurisdiction thereof, hereinafter 
referred to as ``employees of the Public Health Service'', when 
required to be on duty between the hours of 6 o'clock 
postmeridian and 6 o'clock antemeridian (or between the hours 
of 7 o'clock postmeridian and 7 o'clock antemeridian at 
stations which have a declared workday of from 7 o'clock 
antemeridian to 7 o'clock postmeridian), or on Sundays or 
holidays, such rate, in lieu of compensation under any other 
provision of law, to be fixed at two times the basic hourly 
rate for each hour that the overtime extends beyond 6 o'clock 
(or 7 o'clock as the case may be) postmeridian, and two times 
the basic hourly rate for each overtime hour worked on Sundays 
or holidays. As used in this subsection, the term ``basic 
hourly rate'' shall mean the regular basic rate of pay which is 
applicable to such employees for work performed within their 
regular scheduled tour of duty.
    (d)(1) The said extra compensation shall be paid to the 
United States by the owner, agent, consignee, operator, or 
master or other person in charge of any conveyance, for whom, 
at his request, services as described in this subsection 
(hereinafter referred to as overtime service) are performed. If 
such employees have been ordered to report for duty and have so 
reported, and the requested services are not performed by 
reason of circumstances beyond the control of the employees 
concerned, such extra compensation shall be paid on the same 
basis as though the overtime services had actually been 
performed during the period between the time the employees were 
ordered to report for duty and did so report, and the time they 
were notified that their services would not be required, and in 
any case as though their services had continued for not less 
than one hour. The Surgeon General with the approval of the 
Secretary of Health, Education, and Welfare may prescribe 
regulations requiring the owner, agent, consignee, operator, or 
master or other person for whom the overtime services are 
performed to file a bond in such amounts and containing such 
conditions and with such sureties, or in lieu of a bond, to 
deposit money or obligations of the United States in such 
amount, as will assure the payment of charges under this 
subsection, which bond or deposit may cover one or more 
transactions or all transactions during a specified period: 
Provided, That no charges shall be made for services performed 
in connection with the inspection of (1) persons arriving by 
international highways, ferries, bridges, or tunnels, or the 
conveyances in which they arrive, or (2) persons arriving by 
aircraft or railroad trains, the operations of which are 
covered by published schedules, or the aircraft or trains in 
which they arrive, or (3) persons arriving by vessels operated 
between Canadian ports and ports on Puget Sound or operated on 
the Great Lakes and connecting waterways, the operations of 
which are covered by published schedules, or the vessels in 
which they arrive.
    (2) Moneys collected under this subsection shall be 
deposited in the Treasury of the United States to the credit of 
the appropriation charged with the expense of the services, and 
the appropriations so credited shall be available for the 
payment of such compensation to the said employees for services 
so rendered.
             certain duties of consular and other officers
    Sec. 365. [268] (a) Any consular or medical officer of the 
United States, designated for such purpose by the Secretary, 
shall make reports to the Surgeon General, on such forms and at 
such intervals as the Surgeon General may prescribe, of the 
health conditions at the port or place at which such officer is 
stationed.
    (b) It shall be the duty of the customs officers and of 
Coast Guard officers to aid in the enforcement of quarantine 
rules and regulations; but no additional compensation, except 
actual and necessary traveling expenses, shall be allowed any 
such officer by reason of such services.
                            bills of health
    Sec. 366. [269] (a) Except as otherwise prescribed in 
regulations, any vessel at any foreign port or place clearing 
or departing for any port or place in a State or possession 
shall be required to obtain from the consular officer of the 
United States or from the Public Health Service officer, or 
other medical officer of the United States designated by the 
Surgeon General, at the port or place of departure, a bill of 
health in duplicate, in the form prescribed by the Surgeon 
General. The President, from time to time, shall specify the 
ports at which a medical officer shall be stationed for this 
purpose. Such bill of health shall set forth the sanitary 
history and condition of said vessel, and shall state that it 
has in all respects complied with the regulations prescribed 
pursuant to subsection (c). Before granting such duplicate bill 
of health, such consular or medical officer shall be satisfied 
that the matters and things therein stated are true. The 
consular officer shall be entitled to demand and receive the 
fees for bills of health and such fees shall be established by 
regulation.
    (b) Original bills of health shall be delivered to the 
collectors of customs at the port of entry. Duplicate copies of 
such bills of health shall be delivered at the time of 
inspection to quarantine officers at such port. The bills of 
health herein prescribed shall be considered as part of the 
ship's papers, and when duly certified to by the proper 
consular or other officer of the United States, over his 
official signature and seal, shall be accepted as evidence of 
the statements therein contained in any court of the United 
States.
    (c) The Surgeon General shall from time to time prescribe 
regulations, applicable to vessels referred to in subsection 
(a) of this section for the purpose of preventing the 
introduction into the States or possessions of the United 
States of any communicable disease by securing the best 
sanitary condition of such vessels, their cargoes, passengers, 
and crews. Such regulations shall be observed by such vessels 
prior to departure, during the course of the voyage, and also 
during inspection, disinfection, or other quarantine procedure 
upon arrival at any United States quarantine station.
    (d) The provisions of subsections (a) and (b) of this 
section shall not apply to vessels plying between such foreign 
ports on or near the frontiers of the United States and ports 
of the United States as are designated by treaty.
    (e) It shall be unlawful for any vessel to enter any port 
in any State or possession of the United States to discharge 
its cargo, or land its passengers, except upon a certificate of 
the quarantine officer that regulations prescribed under 
subsection (c) have in all respects been complied with by such 
officer, the vessel, and its master. The master of every such 
vessel shall deliver such certificate to the collector of 
customs at the port of entry, together with the original bill 
of health and other papers of the vessel. The certificate 
required by this subsection shall be procurable from the 
quarantine officer, upon arrival of the vessel at the 
quarantine station and satisfactory inspection thereof, at any 
time within which quarantine services are performed at such 
station.
                civil air navigation and civil aircraft
    Sec. 367. [270] The Surgeon General is authorized to 
provide by regulations for the application to air navigation 
and aircraft of any of the provisions of sections 364, 365, and 
366 and regulations prescribed thereunder (including penalties 
and forfeitures for violations of such sections and 
regulations), to such extent and upon such conditions as he 
deems necessary for the safeguarding of the public health.
                               penalties
    Sec. 368. [271] (a) Any person who violates any regulation 
prescribed under section 361, 362, or 363, or any provision of 
section 366 or any regulation prescribed thereunder, or who 
enters or departs from the limits of any quarantine station, 
ground, or anchorage in disregard of quarantine rules and 
regulations or without permission of the quarantine officer in 
charge, shall be punished by a fine of not more than $1,000 or 
by imprisonment for not more than one year, or both.
    (b) Any vessel which violates section 366, or any 
regulations thereunder or under section 364, or which enters 
within or departs from the limits of any quarantine station, 
ground, or anchorage in disregard of the quarantine rules and 
regulations or without permission of the officer in charge, 
shall forfeit to the United States not more than $5,000, the 
amount to be determined by the court, which shall be a lien on 
such vessel, to be recovered by proceedings in the proper 
district court of the United States. In all such proceedings 
the United States attorney shall appear on behalf of the United 
States; and all such proceedings shall be conducted in 
accordance with the rules and laws governing cases of seizure 
of vessels for violation of the revenue laws of the United 
States.
    (c) With the approval of the Secretary, the Surgeon General 
may, upon application therefor, remit or mitigate any 
forfeiture provided for under subsection (b) of this section, 
and he shall have authority to ascertain the facts upon all 
such applications.
                        administration of oaths
    Sec. 369. [272] Medical officers of the United States, when 
performing duties as quarantine officers at any port or place 
within the United States, are authorized to take declarations 
and administer oaths in matters pertaining to the 
administration of the quarantine laws and regulations of the 
United States.

                     Part H--Organ Transplants \1\
---------------------------------------------------------------------------
    \1\ Section 301 of the National Organ Transplant Act (Public Law 
98-507; 42 U.S.C. 274e) provides:

    Sec. 301. (a) It shall be unlawful for any person to knowingly 
acquire, receive, or otherwise transfer any human organ for valuable 
consideration for use in human transplantaion if the transfer affects 
interstate commerce.
    (b) Any person who violates subsection (a) shall be fined not more 
than $50,000 or imprisoned not more than five years, or both.
    (c) For purposes of subsection (a):
---------------------------------------------------------------------------

          (1) The term ``human organ'' means the human (including 
        fetal) kidney, liver, heart, lung, pancreas, bone marrow, 
        cornea, eye, bone, and skin or any subpart thereof and any 
        other human organ (or any subpart thereof, including that 
        derived from a fetus) specified by the Secretary of Health and 
        Human Services by regulation.
          (2) The term ``valuable consideration'' does not include the 
        reasonable payments associated with the removal, 
        transportation, implantation, processing, preservation, quality 
        control, and storage of a human organ or the expenses of 
        travel, housing, and lost wages incurred by the donor of a 
        human organ in connection with the donation of the organ.
          (3) The term ``interstate commerce'' has the meaning 
        prescribed for it by section 201(b) of the Federal Food, Drug 
        and Cosmetic Act.
                    organ procurement organizations
    Sec. 371. [273] (a)(1) The Secretary may make grants for 
the planning of qualified organ procurement organizations 
described in subsection (b).
    (2) The Secretary may make grants for the establishment, 
initial operation, consolidation, and expansion of qualified 
organ procurement organizations described in subsection (b).
    (b)(1) \2\ A qualified organ procurement organization for 
which grants may be made under subsection (a) is an 
organization which, as determined by the Secretary, will carry 
out the functions described in paragraph (2) \3\ and--
---------------------------------------------------------------------------
    \2\ So in law. Subparagraphs (D) and (E) have the same text, and 
there are two subparagraphs (H). This results from the same set of 
amendments to section 371(b)(1) being enacted twice. The first set of 
amendments was made by section 701(c) of Public Law 106-505 (114 Stat. 
2347). These amendments redesignated subparagraphs (D) through (G) as 
subparagraphs (E) through (H), respectively, and then added a new 
subparagraph (D). The second set was made by section 219(b) of the 
Departments of Labor, Health and Human Services, and Education, and 
Related Agencies Appropriations Act, 2001 (as enacted into law by 
section 1(a)(1) of Public Law 106-554; 114 Stat. 2763A-29). Per the 
second set of amendments, the subparagraph (D) added by the first set 
was redesignated as (E), and the same text was again added as a 
subparagraph (D). Per the second set, subparagraphs (F) and (G), as 
redesignated by the first set, were redesignated as (G) and (H), which 
resulted in there being two subparagraphs (H).
    \3\ So in law. Probably should be ``paragraph (3)''.
---------------------------------------------------------------------------
            (A) is a nonprofit entity,
            (B) has accounting and other fiscal procedures (as 
        specified by the Secretary) necessary to assure the 
        fiscal stability of the organization,
            (C) has an agreement with the Secretary to be 
        reimbursed under title XVIII of the Social Security Act 
        for the procurement of kidneys,
            (D) notwithstanding any other provision of law, has 
        met the other requirements of this section and has been 
        certified or recertified by the Secretary within the 
        previous 4-year period as meeting the performance 
        standards to be a qualified organ procurement 
        organization through a process that either--
                    (i) granted certification or 
                recertification within such 4-year period with 
                such certification or recertification in effect 
                as of January 1, 2000, and remaining in effect 
                through the earlier of--
                            (I) January 1, 2002; or
                            (II) the completion of 
                        recertification under the requirements 
                        of clause (ii); or
                    (ii) is defined through regulations that 
                are promulgated by the Secretary by not later 
                than January 1, 2002, that--
                            (I) require recertifications of 
                        qualified organ procurement 
                        organizations not more frequently than 
                        once every 4 years;
                            (II) rely on outcome and process 
                        performance measures that are based on 
                        empirical evidence, obtained through 
                        reasonable efforts, of organ donor 
                        potential and other related factors in 
                        each service area of qualified organ 
                        procurement organizations;
                            (III) use multiple outcome measures 
                        as part of the certification process; 
                        and
                            (IV) provide for a qualified organ 
                        procurement organization to appeal a 
                        decertification to the Secretary on 
                        substantive and procedural grounds;
            (E) notwithstanding any other provision of law, has 
        met the other requirements of this section and has been 
        certified or recertified by the Secretary within the 
        previous 4-year period as meeting the performance 
        standards to be a qualified organ procurement 
        organization through a process that either--
                    (i) granted certification or 
                recertification within such 4-year period with 
                such certification or recertification in effect 
                as of January 1, 2000, and remaining in effect 
                through the earlier of--
                            (I) January 1, 2002; or
                            (II) the completion of 
                        recertification under the requirements 
                        of clause (ii); or
                    (ii) is defined through regulations that 
                are promulgated by the Secretary by not later 
                than January 1, 2002, that--
                            (I) require recertifications of 
                        qualified organ procurement 
                        organizations not more frequently than 
                        once every 4 years;
                            (II) rely on outcome and process 
                        performance measures that are based on 
                        empirical evidence, obtained through 
                        reasonable efforts, of organ donor 
                        potential and other related factors in 
                        each service area of qualified organ 
                        procurement organizations;
                            (III) use multiple outcome measures 
                        as part of the certification process; 
                        and
                            (IV) provide for a qualified organ 
                        procurement organization to appeal a 
                        decertification to the Secretary on 
                        substantive and procedural grounds; \1\
---------------------------------------------------------------------------
    \1\ So in law. Subparagraphs (D) and (E) have semicolons at the end 
of organizational units, rather than commas.
---------------------------------------------------------------------------
            (F) has procedures to obtain payment for non-renal 
        organs provided to transplant centers,
            (G) has a defined service area that is of 
        sufficient size to assure maximum effectiveness in the 
        procurement and equitable distribution of organs, and 
        that either includes an entire metropolitan statistical 
        area (as specified by the Director of the Office of 
        Management and Budget) or does not include any part of 
        the area,
            (H) has a director and such other staff, including 
        the organ donation coordinators and organ procurement 
        specialists necessary to effectively obtain organs from 
        donors in its service area, and
            (H) has a board of directors or an advisory board 
        which--
                    (i) is composed of--
                            (I) members who represent hospital 
                        administrators, intensive care or 
                        emergency room personnel, tissue banks, 
                        and voluntary health associations in 
                        its service area,
                            (II) members who represent the 
                        public residing in such area,
                            (III) a physician with knowledge, 
                        experience, or skill in the field of 
                        histocompatability \1\ or an individual 
                        with a doctorate degree in a biological 
                        science with knowledge, experience, or 
                        skill in the field of 
                        histocompatibility,
---------------------------------------------------------------------------
    \1\ So in law. Probably should be ``histocompatibility''.
---------------------------------------------------------------------------
                            (IV) a physician with knowledge or 
                        skill in the field of neurology, and
                            (V) from each transplant center in 
                        its service area which has arrangements 
                        described in paragraph (2) \2\(G) with 
                        the organization, a member who is a 
                        surgeon who has practicing privileges 
                        in such center and who performs organ 
                        transplant surgery,
                    (ii) has the authority to recommend 
                policies for the procurement of organs and the 
                other functions described in paragraph (2) \2\, 
                and
---------------------------------------------------------------------------
    \2\ So in law. Probably should be paragraph (3).
---------------------------------------------------------------------------
                    (iii) has no authority over any other 
                activity of the organization.
    (2)(A) Not later than 90 days after the date of the 
enactment of this paragraph, \3\ the Secretary shall publish in 
the Federal Register a notice of proposed rulemaking to 
establish criteria for determining whether an entity meets the 
requirement established in paragraph (1)(E).
---------------------------------------------------------------------------
    \3\ Enacted November 16, 1990. See section 201(d) of Public Law 
101-616.
---------------------------------------------------------------------------
    (B) Not later than 1 year after the date of enactment of 
this paragraph, \3\ the Secretary shall publish in the Federal 
Register a final rule to establish the criteria described in 
subparagraph (A).
    (3) An organ procurement organization shall--
            (A) have effective agreements, to identify 
        potential organ donors, with a substantial majority of 
        the hospitals and other health care entities in its 
        service area which have facilities for organ donations,
            (B) conduct and participate in systematic efforts, 
        including professional education, to acquire all usable 
        organs from potential donors,
            (C) arrange for the acquisition and preservation of 
        donated organs and provide quality standards for the 
        acquisition of organs which are consistent with the 
        standards adopted by the Organ Procurement and 
        Transplantation Network under section 372(b)(2)(E), 
        including arranging for testing with respect to 
        preventing the acquisition of organs that are infected 
        with the etiologic agent for acquired immune deficiency 
        syndrome,
            (D) arrange for the appropriate tissue typing of 
        donated organs,
            (E) have a system to allocate donated organs 
        equitably among transplant patients according to 
        established medical criteria,
            (F) provide or arrange for the transportation of 
        donated organs to transplant centers,
            (G) have arrangements to coordinate its activities 
        with transplant centers in its service area,
            (H) participate in the Organ Procurement 
        Transplantation Network established under section 372,
            (I) have arrangements to cooperate with tissue 
        banks for the retrieval, processing, preservation, 
        storage, and distribution of tissues as may be 
        appropriate to assure that all usable tissues are 
        obtained from potential donors,
            (J) evaluate annually the effectiveness of the 
        organization in acquiring potentially available organs, 
        and
            (K) assist hospitals in establishing and 
        implementing protocols for making routine inquiries 
        about organ donations by potential donors.
    (c) Pancreata procured by an organ procurement organization 
and used for islet cell transplantation or research shall be 
counted for purposes of certification or recertification under 
subsection (b).

SEC. 371A. [273A] NATIONAL LIVING DONOR MECHANISMS.

    The Secretary may establish and maintain mechanisms to 
evaluate the long-term effects associated with living organ 
donations by individuals who have served as living donors.

             organ procurement and transplantation network

    Sec. 372. [274] (a) The Secretary shall by contract provide 
for the establishment and operation of an Organ Procurement and 
Transplantation Network which meets the requirements of 
subsection (b). The amount provided under such contract in any 
fiscal year may not exceed $7,000,000. Funds for such contracts 
shall be made available from funds available to the Public 
Health Service from appropriations for fiscal years beginning 
after fiscal year 1984.
    (b)(1) The Organ Procurement and Transplantation Network 
shall carry out the functions described in paragraph (2) and 
shall--
            (A) be a private nonprofit entity that has an 
        expertise in organ procurement and transplantation, and
            (B) have a board of directors--
                    (i) that includes representatives of organ 
                procurement organizations (including 
                organizations that have received grants under 
                section 371), transplant centers, voluntary 
                health associations, and the general public; 
                and
                    (ii) that shall establish an executive 
                committee and other committees, whose 
                chairpersons shall be selected to ensure 
                continuity of leadership for the board.
    (2) The Organ Procurement and Transplantation Network 
shall--
            (A) establish in one location or through regional 
        centers--
                    (i) a national list of individuals who need 
                organs, and
                    (ii) a national system, through the use of 
                computers and in accordance with established 
                medical criteria, to match organs and 
                individuals included in the list, especially 
                individuals whose immune system makes it 
                difficult for them to receive organs,
            (B) establish membership criteria and medical 
        criteria for allocating organs and provide to members 
        of the public an opportunity to comment with respect to 
        such criteria,
            (C) maintain a twenty-four-hour telephone service 
        to facilitate matching organs with individuals included 
        in the list,
            (D) assist organ procurement organizations in the 
        nationwide distribution of organs equitably among 
        transplant patients,
            (E) adopt and use standards of quality for the 
        acquisition and transportation of donated organs, 
        including standards for preventing the acquisition of 
        organs that are infected with the etiologic agent for 
        acquired immune deficiency syndrome,
            (F) prepare and distribute, on a regionalized basis 
        (and, to the extent practicable, among regions or on a 
        national basis), samples of blood sera from individuals 
        who are included on the list and whose immune system 
        makes it difficult for them to receive organs, in order 
        to facilitate matching the compatibility of such 
        individuals with organ donors,
            (G) coordinate, as appropriate, the transportation 
        of organs from organ procurement organizations to 
        transplant centers,
            (H) provide information to physicians and other 
        health professionals regarding organ donation,
            (I) collect, analyze, and publish data concerning 
        organ donation and transplants,
            (J) carry out studies and demonstration projects 
        for the purpose of improving procedures for organ 
        procurement and allocation,
            (K) work actively to increase the supply of donated 
        organs,
            (L) submit to the Secretary an annual report 
        containing information on the comparative costs and 
        patient outcomes at each transplant center affiliated 
        with the organ procurement and transplantation network,
                    (M) \1\ recognize the differences in health 
                and in organ transplantation issues between 
                children and adults throughout the system and 
                adopt criteria, polices, and procedures that 
                address the unique health care needs of 
                children,
---------------------------------------------------------------------------
    \1\ Indentation is so in law. See section 2101(a)(3) of Public Law 
106-310 (114 Stat. 1156).
---------------------------------------------------------------------------
                    (N) \1\ carry out studies and demonstration 
                projects for the purpose of improving 
                procedures for organ donation procurement and 
                allocation, including but not limited to 
                projects to examine and attempt to increase 
                transplantation among populations with special 
                needs, including children and individuals who 
                are members of racial or ethnic minority 
                groups, and among populations with limited 
                access to transportation, and
                    (O) \1\ provide that for purposes of this 
                paragraph, the term ``children'' refers to 
                individuals who are under the age of 18.
---------------------------------------------------------------------------
    \1\ See footnote for subparagraph (M).
---------------------------------------------------------------------------
    (c) The Secretary shall establish procedures for--
            (1) receiving from interested persons critical 
        comments relating to the manner in which the Organ 
        Procurement and Transplantation Network is carrying out 
        the duties of the Network under subsection (b); and
            (2) the consideration by the Secretary of such 
        critical comments.

                          scientific registry

    Sec. 373. [274a] The Secretary shall, by grant or contract, 
develop and maintain a scientific registry of the recipients of 
organ transplants. The registry shall include such information 
respecting patients and transplant procedures as the Secretary 
deems necessary to an ongoing evaluation of the scientific and 
clinical status of organ transplantation. The Secretary shall 
prepare for inclusion in the report under section 376 an 
analysis of information derived from the registry.

           general provisions respecting grants and contracts

    Sec. 374. [274b] (a) No grant may be made under this part 
or contract entered into under section 372 or 373 unless an 
application therefor has been submitted to, and approved by, 
the Secretary. Such an application shall be in such form and 
shall be submitted in such manner as the Secretary shall by 
regulation prescribe.
    (b)(1) A grant for planning under section 371(a)(1) may be 
made for one year with respect to any organ procurement 
organization and may not exceed $100,000.
    (2) Grants under section 371(a)(2) may be made for two 
years. No such grant may exceed $500,000 for any year and no 
organ procurement organization may receive more than $800,000 
for initial operation or expansion.
    (3) Grants or contracts under section 371(a)(3) may be made 
for not more than 3 years.
    (c)(1) The Secretary shall determine the amount of a grant 
or contract made under section 371 or 373. Payments under such 
grants and contracts may be made in advance on the basis of 
estimates or by the way of reimbursement, with necessary 
adjustments on account of underpayments or overpayments, and in 
such installments and on such terms and conditions as the 
Secretary finds necessary to carry out the purposes of such 
grants and contracts.
    (2)(A) Each recipient of a grant or contract under section 
371 or 373 shall keep such records as the Secretary shall 
prescribe, including records which fully disclose the amount 
and disposition by such recipient of the proceeds of such grant 
or contract, the total cost of the undertaking in connection 
with which such grant or contract was made, and the amount of 
that portion of the cost of the undertaking supplied by other 
sources, and such other records as will facilitate an effective 
audit.
    (B) The Secretary and the Comptroller General of the United 
States, or any of their duly authorized representatives, shall 
have access for the purpose of audit and examination to any 
books, documents, papers, and records of the recipient of a 
grant or contract under section 371 or 373 that are pertinent 
to such grant or contract.
    (d) For purposes of this part:
            (1) The term ``transplant center'' means a health 
        care facility in which transplants of organs are 
        performed.
            (2) The term ``organ'' means the human kidney, 
        liver, heart, lung, pancreas, and any other human organ 
        (other than corneas and eyes) specified by the 
        Secretary by regulation and for purposes of section 
        373, such term includes bone marrow.

                             administration

    Sec. 375. [274c] The Secretary shall designate and maintain 
an identifiable administrative unit in the Public Health 
Service to--
            (1) administer this part and coordinate with the 
        organ procurement activities under title XVIII of the 
        Social Security Act,
            (2) conduct a program of public information to 
        inform the public of the need for organ donations,
            (3) provide technical assistance to organ 
        procurement organizations, the Organ Procurement and 
        Transplantation Network established under section 372, 
        and other entities in the health care system involved 
        in organ donations, procurement, and transplants, and
            (4) provide information--
                    (i) \1\ to patients, their families, and 
                their physicians about transplantation; and
---------------------------------------------------------------------------
    \1\ Clauses (i) and (ii) probably should be redesignated as 
subparagraphs (A) and (B). See section 204(b)(2) of Public Law 101-616 
(104 Stat. 3285).
---------------------------------------------------------------------------
                    (ii) \1\ to patients and their families 
                about the resources available nationally and in 
                each State, and the comparative costs and 
                patient outcomes at each transplant center 
                affiliated with the organ procurement and 
                transplantation network, in order to assist the 
                patients and families with the costs associated 
                with transplantation.

                                 report

    Sec. 376. [274d] Not later than February 10 of 1991 and of 
each second year thereafter, the Secretary shall publish, and 
submit to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Labor and Human Resources 
of the Senate. \2\ a report on the scientific and clinical 
status of organ transplantation. The Secretary shall consult 
with the Director of the National Institutes of Health and the 
Commissioner of the Food and Drug Administration in the 
preparation of the report.
---------------------------------------------------------------------------
    \2\ So in law. There probably should be a comma after ``Senate'' 
rather than a period. See section 205 of Public Law 101-616.
---------------------------------------------------------------------------

SEC. 377. [274F] REIMBURSEMENT OF TRAVEL AND SUBSISTENCE EXPENSES 
                    INCURRED TOWARD LIVING ORGAN DONATION.

    (a) In General.--The Secretary may award grants to States, 
transplant centers, qualified organ procurement organizations 
under section 371, or other public or private entities for the 
purpose of--
            (1) providing for the reimbursement of travel and 
        subsistence expenses incurred by individuals toward 
        making living donations of their organs (in this 
        section referred to as ``donating individuals''); and
            (2) providing for the reimbursement of such 
        incidental nonmedical expenses that are so incurred as 
        the Secretary determines by regulation to be 
        appropriate.
    (b) Preference.--The Secretary shall, in carrying out 
subsection (a), give preference to those individuals that the 
Secretary determines are more likely to be otherwise unable to 
meet such expenses.
    (c) Certain Circumstances.--The Secretary may, in carrying 
out subsection (a), consider--
            (1) the term ``donating individuals'' as including 
        individuals who in good faith incur qualifying expenses 
        toward the intended donation of an organ but with 
        respect to whom, for such reasons as the Secretary 
        determines to be appropriate, no donation of the organ 
        occurs; and
            (2) the term ``qualifying expenses'' as including 
        the expenses of having relatives or other individuals, 
        not to exceed 2, accompany or assist the donating 
        individual for purposes of subsection (a) (subject to 
        making payment for only those types of expenses that 
        are paid for a donating individual).
    (d) Relationship to Payments Under Other Programs.--An 
award may be made under subsection (a) only if the applicant 
involved agrees that the award will not be expended to pay the 
qualifying expenses of a donating individual to the extent that 
payment has been made, or can reasonably be expected to be 
made, with respect to such expenses--
            (1) under any State compensation program, under an 
        insurance policy, or under any Federal or State health 
        benefits program;
            (2) by an entity that provides health services on a 
        prepaid basis; or
            (3) by the recipient of the organ.
    (e) Definitions.--For purposes of this section:
            (1) The term ``donating individuals'' has the 
        meaning indicated for such term in subsection (a)(1), 
        subject to subsection (c)(1).
            (2) The term ``qualifying expenses'' means the 
        expenses authorized for purposes of subsection (a), 
        subject to subsection (c)(2).
    (f) Authorization of Appropriations.--For the purpose of 
carrying out this section, there is authorized to be 
appropriated $5,000,000 for each of the fiscal years 2005 
through 2009.

SEC. 377A. [274F-1] PUBLIC AWARENESS; STUDIES AND DEMONSTRATIONS.

    (a) Organ Donation Public Awareness Program.--The Secretary 
shall, directly or through grants or contracts, establish a 
public education program in cooperation with existing national 
public awareness campaigns to increase awareness about organ 
donation and the need to provide for an adequate rate of such 
donations.
    (b) Studies and Demonstrations.--The Secretary may make 
peer-reviewed grants to, or enter into peer-reviewed contracts 
with, public and nonprofit private entities for the purpose of 
carrying out studies and demonstration projects to increase 
organ donation and recovery rates, including living donation.
    (c) Grants to States.--
            (1) In general.--The Secretary may make grants to 
        States for the purpose of assisting States in carrying 
        out organ donor awareness, public education, and 
        outreach activities and programs designed to increase 
        the number of organ donors within the State, including 
        living donors.
            (2) Eligibility.--To be eligible to receive a grant 
        under this subsection, a State shall--
                    (A) submit an application to the Department 
                in the form prescribed;
                    (B) establish yearly benchmarks for 
                improvement in organ donation rates in the 
                State; and
                    (C) report to the Secretary on an annual 
                basis a description and assessment of the 
                State's use of funds received under this 
                subsection, accompanied by an assessment of 
                initiatives for potential replication in other 
                States.
            (3) Use of funds.--Funds received under this 
        subsection may be used by the State, or in partnership 
        with other public agencies or private sector 
        institutions, for education and awareness efforts, 
        information dissemination, activities pertaining to the 
        State donor registry, and other innovative donation 
        specific initiatives, including living donation.
    (d) Educational Activities.--The Secretary, in coordination 
with the Organ Procurement and Transplantation Network and 
other appropriate organizations, shall support the development 
and dissemination of educational materials to inform health 
care professionals and other appropriate professionals in 
issues surrounding organ, tissue, and eye donation including 
evidence-based proven methods to approach patients and their 
families, cultural sensitivities, and other relevant issues.
    (e) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated $15,000,000 for fiscal year 2005, and such sums as 
may be necessary for each of the fiscal years 2006 through 
2009. Such authorization of appropriations is in addition to 
any other authorizations of appropriations that are available 
for such purpose.

SEC. 377B. [274F-2] GRANTS REGARDING HOSPITAL ORGAN DONATION 
                    COORDINATORS.

    (a) Authority.--
            (1) In general.--The Secretary may award grants to 
        qualified organ procurement organizations and hospitals 
        under section 371 to establish programs coordinating 
        organ donation activities of eligible hospitals and 
        qualified organ procurement organizations under section 
        371. Such activities shall be coordinated to increase 
        the rate of organ donations for such hospitals.
            (2) Eligible hospital.--For purposes of this 
        section, the term ``eligible hospital'' means a 
        hospital that performs significant trauma care, or a 
        hospital or consortium of hospitals that serves a 
        population base of not fewer than 200,000 individuals.
    (b) Administration of Coordination Program.--A condition 
for the receipt of a grant under subsection (a) is that the 
applicant involved agree that the program under such subsection 
will be carried out jointly--
            (1) by representatives from the eligible hospital 
        and the qualified organ procurement organization with 
        respect to which the grant is made; and
            (2) by such other entities as the representatives 
        referred to in paragraph (1) may designate.
    (c) Requirements.--Each entity receiving a grant under 
subsection (a) shall--
            (1) establish joint organ procurement organization 
        and hospital designated leadership responsibility and 
        accountability for the project;
            (2) develop mutually agreed upon overall project 
        performance goals and outcome measures, including 
        interim outcome targets; and
            (3) collaboratively design and implement an 
        appropriate data collection process to provide ongoing 
        feedback to hospital and organ procurement organization 
        leadership on project progress and results.
    (d) Rule of Construction.--Nothing in this section shall be 
construed to interfere with regulations in force on the date of 
enactment of the Organ Donation and Recovery Improvement Act.
    (e) Evaluations.--Within 3 years after the award of grants 
under this section, the Secretary shall ensure an evaluation of 
programs carried out pursuant to subsection (a) in order to 
determine the extent to which the programs have increased the 
rate of organ donation for the eligible hospitals involved.
    (f) Matching Requirement.--The Secretary may not award a 
grant to a qualifying organ donation entity under this section 
unless such entity agrees that, with respect to costs to be 
incurred by the entity in carrying out activities for which the 
grant was awarded, the entity shall contribute (directly or 
through donations from public or private entities) non-Federal 
contributions in cash or in kind, in an amount equal to not 
less than 30 percent of the amount of the grant awarded to such 
entity.
    (g) Funding.--For the purpose of carrying out this section, 
there are authorized to be appropriated $3,000,000 for fiscal 
year 2005, and such sums as may be necessary for each of fiscal 
years 2006 through 2009.

SEC. 377C. [274F-3] STUDIES RELATING TO ORGAN DONATION AND THE 
                    RECOVERY, PRESERVATION, AND TRANSPORTATION OF 
                    ORGANS.

    (a) Development of Supportive Information.--The Secretary, 
acting through the Director of the Agency for Healthcare 
Research and Quality, shall develop scientific evidence in 
support of efforts to increase organ donation and improve the 
recovery, preservation, and transportation of organs.
    (b) Activities.--In carrying out subsection (a), the 
Secretary shall--
            (1) conduct or support evaluation research to 
        determine whether interventions, technologies, or other 
        activities improve the effectiveness, efficiency, or 
        quality of existing organ donation practice;
            (2) undertake or support periodic reviews of the 
        scientific literature to assist efforts of professional 
        societies to ensure that the clinical practice 
        guidelines that they develop reflect the latest 
        scientific findings;
            (3) ensure that scientific evidence of the research 
        and other activities undertaken under this section is 
        readily accessible by the organ procurement workforce; 
        and
            (4) work in coordination with the appropriate 
        professional societies as well as the Organ Procurement 
        and Transplantation Network and other organ procurement 
        and transplantation organizations to develop evidence 
        and promote the adoption of such proven practices.
    (c) Research and Dissemination.--The Secretary, acting 
through the Director of the Agency for Healthcare Research and 
Quality, as appropriate, shall provide support for research and 
dissemination of findings, to--
            (1) develop a uniform clinical vocabulary for organ 
        recovery;
            (2) apply information technology and 
        telecommunications to support the clinical operations 
        of organ procurement organizations;
            (3) enhance the skill levels of the organ 
        procurement workforce in undertaking quality 
        improvement activities; and
            (4) assess specific organ recovery, preservation, 
        and transportation technologies.
    (d) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated $2,000,000 for fiscal year 2005, and such sums as 
may be necessary for each of fiscal years 2006 through 2009.

SEC. 377D. [274F-4] REPORT RELATING TO ORGAN DONATION AND THE RECOVERY, 
                    PRESERVATION, AND TRANSPORTATION OF ORGANS.

    (a) In General.--Not later than December 31, 2005, and 
every 2 years thereafter, the Secretary shall report to the 
appropriate committees of Congress on the activities of the 
Department carried out pursuant to this part, including an 
evaluation describing the extent to which the activities have 
affected the rate of organ donation and recovery.
    (b) Requirements.--To the extent practicable, each report 
submitted under subsection (a) shall--
            (1) evaluate the effectiveness of activities, 
        identify effective activities, and disseminate such 
        findings with respect to organ donation and recovery;
            (2) assess organ donation and recovery activities 
        that are recently completed, ongoing, or planned; and
            (3) evaluate progress on the implementation of the 
        plan required under subsection (c)(5).
    (c) Initial Report Requirements.--The initial report under 
subsection (a) shall include the following:
            (1) An evaluation of the organ donation practices 
        of organ procurement organizations, States, other 
        countries, and other appropriate organizations 
        including an examination across all populations, 
        including those with low organ donation rates, of--
                    (A) existing barriers to organ donation; 
                and
                    (B) the most effective donation and 
                recovery practices.
            (2) An evaluation of living donation practices and 
        procedures. Such evaluation shall include an assessment 
        of issues relating to informed consent and the health 
        risks associated with living donation (including 
        possible reduction of long-term effects).
            (3) An evaluation of--
                    (A) federally supported or conducted organ 
                donation efforts and policies, as well as 
                federally supported or conducted basic, 
                clinical, and health services research 
                (including research on preservation techniques 
                and organ rejection and compatibility); and
                    (B) the coordination of such efforts across 
                relevant agencies within the Department and 
                throughout the Federal Government.
            (4) An evaluation of the costs and benefits of 
        State donor registries, including the status of 
        existing State donor registries, the effect of State 
        donor registries on organ donation rates, issues 
        relating to consent, and recommendations regarding 
        improving the effectiveness of State donor registries 
        in increasing overall organ donation rates.
            (5) A plan to improve federally supported or 
        conducted organ donation and recovery activities, 
        including, when appropriate, the establishment of 
        baselines and benchmarks to measure overall outcomes of 
        these programs. Such plan shall provide for the ongoing 
        coordination of federally supported or conducted organ 
        donation and research activities.

SEC. 378. [274G] AUTHORIZATION OF APPROPRIATIONS.

    For the purpose of carrying out this part, there are 
authorized to be appropriated $8,000,000 for fiscal year 1991, 
and such sums as may be necessary for each of the fiscal years 
1992 and 1993.

          PART I--C.W. BILL YOUNG CELL TRANSPLANTATION PROGRAM

SEC. 379. [274K] NATIONAL PROGRAM.

    (a) Establishment.--The Secretary, acting through the 
Administrator of the Health Resources and Services 
Administration, shall by one or more contracts establish and 
maintain a C.W. Bill Young Cell Transplantation Program 
(referred to in this section as the ``Program''), successor to 
the National Bone Marrow Donor Registry, that has the purpose 
of increasing the number of transplants for recipients suitably 
matched to biologically unrelated donors of bone marrow and 
cord blood, and that meets the requirements of this section. 
The Secretary may award a separate contract to perform each of 
the major functions of the Program described in paragraphs (1) 
and (2) of subsection (d) if deemed necessary by the Secretary 
to operate an effective and efficient system that is in the 
best interest of patients. The Secretary shall conduct a 
separate competition for the initial establishment of the cord 
blood functions of the Program. The Program shall be under the 
general supervision of the Secretary. The Secretary shall 
establish an Advisory Council to advise, assist, consult with, 
and make recommendations to the Secretary on matters related to 
the activities carried out by the Program. The members of the 
Advisory Council shall be appointed in accordance with the 
following:
            (1) Each member of the Advisory Council shall serve 
        for a term of 2 years, and each such member may serve 
        as many as 3 consecutive 2-year terms, except that--
                    (A) such limitations shall not apply to the 
                Chair of the Advisory Council (or the Chair-
                elect) or to the member of the Advisory Council 
                who most recently served as the Chair; and
                    (B) one additional consecutive 2-year term 
                may be served by any member of the Advisory 
                Council who has no employment, governance, or 
                financial affiliation with any donor center, 
                recruitment organization, transplant center, or 
                cord blood bank.
            (2) A member of the Advisory Council may continue 
        to serve after the expiration of the term of such 
        member until a successor is appointed.
            (3) In order to ensure the continuity of the 
        Advisory Council, the Advisory Council shall be 
        appointed so that each year the terms of approximately 
        one-third of the members of the Advisory Council 
        expire.
            (4) The membership of the Advisory Council--
                    (A) shall include as voting members a 
                balanced number of representatives including 
                representatives of marrow donor centers and 
                marrow transplant centers, representatives of 
                cord blood banks and participating birthing 
                hospitals, recipients of a bone marrow 
                transplant, recipients of a cord blood 
                transplant, persons who require such 
                transplants, family members of such a recipient 
                or family members of a patient who has 
                requested the assistance of the Program in 
                searching for an unrelated donor of bone marrow 
                or cord blood, persons with expertise in bone 
                marrow and cord blood transplantation, persons 
                with expertise in typing, matching, and 
                transplant outcome data analysis, persons with 
                expertise in the social sciences, basic 
                scientists with expertise in the biology of 
                adult stem cells, and members of the general 
                public; and
                    (B) shall include as nonvoting members 
                representatives from the Department of Defense 
                Marrow Donor Recruitment and Research Program 
                operated by the Department of the Navy, the 
                Division of Transplantation of the Health 
                Resources and Services Administration, the Food 
                and Drug Administration, and the National 
                Institutes of Health.
            (5) Members of the Advisory Council shall be chosen 
        so as to ensure objectivity and balance and reduce the 
        potential for conflicts of interest. The Secretary 
        shall establish bylaws and procedures--
                    (A) to prohibit any member of the Advisory 
                Council who has an employment, governance, or 
                financial affiliation with a donor center, 
                recruitment organization, transplant center, or 
                cord blood bank from participating in any 
                decision that materially affects the center, 
                recruitment organization, transplant center, or 
                cord blood bank; and
                    (B) to limit the number of members of the 
                Advisory Council with any such affiliation.
            (6) The Secretary, acting through the Advisory 
        Council, shall submit to the Congress--
                    (A) an annual report on the activities 
                carried out under this section; and
                    (B) not later than 6 months after the date 
                of the enactment of the Stem Cell Therapeutic 
                and Research Act of 2005, a report of 
                recommendations on the scientific factors 
                necessary to define a cord blood unit as a 
                high-quality unit.
    (b) Accreditation.--The Secretary shall, through a public 
process, recognize one or more accreditation entities for the 
accreditation of cord blood banks.
    (c) Informed Consent.--The Secretary shall, through a 
public process, examine issues of informed consent, including--
            (1) the appropriate timing of such consent; and
            (2) the information provided to the maternal donor 
        regarding all of her medically appropriate cord blood 
        options.
Based on such examination, the Secretary shall require that the 
standards used by the accreditation entities recognized under 
subsection (b) ensure that a cord blood unit is acquired with 
the informed consent of the maternal donor.
    (d) Functions.-- \1\
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    \1\ Section 5 of Public Law 105-196 (112 Stat. 636) provides as 
follows:
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``SEC. 5. STUDY BY GENERAL ACCOUNTING OFFICE.
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    ``(a) In General.--During the period indicated pursuant to 
subsection (b), the Comptroller General of the United States shall 
conduct a study of the National Bone Marrow Donor Registry under 
section 379 of the Public Health Service Act for purposes of making 
determinations of the following:
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          ``(1) The extent to which, relative to the effective date of 
        this Act, such Registry has increased the representation of 
        racial and ethnic minority groups (including persons of mixed 
        ancestry) among potential donors of bone marrow who are 
        enrolled with the Registry, and whether the extent of increase 
        results in a level of representation that meets the standard 
        established in subsection (c)(1)(A) of such section 379 (as 
        added by section 2(c) of this Act).
          ``(2) The extent to which patients in need of a transplant of 
        bone marrow from a biologically unrelated donor, and the 
        physicians of such patients, have been utilizing the Registry 
        in the search for such a donor.
          ``(3) The number of such patients for whom the Registry began 
        a preliminary search but for whom the full search process was 
        not completed, and the reasons underlying such circumstances.
          ``(4) The extent to which the plan required in section 
        2(b)(2) of this Act (relating to the relationship between the 
        Registry and donor centers) has been implemented.
          ``(5) The extent to which the Registry, donor centers, donor 
        registries, collection centers, transplant centers, and other 
        appropriate entities have been complying with the standards, 
        criteria, and procedures under subsection (e) of such section 
        379 (as redesignated by section 2(c) of this Act).
---------------------------------------------------------------------------
    ``(b) Report.--A report describing the findings of the study under 
subsection (a) shall be submitted to the Congress not later than 
October 1, 2001. The report may not be submitted before January 1, 
2001.''.
---------------------------------------------------------------------------
            (1) Bone marrow functions.--With respect to bone 
        marrow, the Program shall--
                    (A) operate a system for identifying, 
                matching, and facilitating the distribution of 
                bone marrow that is suitably matched to 
                candidate patients;
                    (B) consistent with paragraph (3), permit 
                transplant physicians, other appropriate health 
                care professionals, and patients to search by 
                means of electronic access all available bone 
                marrow donors listed in the Program;
                    (C) carry out a program for the recruitment 
                of bone marrow donors in accordance with 
                subsection (e), including with respect to 
                increasing the representation of racial and 
                ethnic minority groups (including persons of 
                mixed ancestry) in the enrollment of the 
                Program;
                    (D) maintain and expand medical contingency 
                response capabilities, in coordination with 
                Federal programs, to prepare for and respond 
                effectively to biological, chemical, or 
                radiological attacks, and other public health 
                emergencies that can damage marrow, so that the 
                capability of supporting patients with marrow 
                damage from disease can be used to support 
                casualties with marrow damage;
                    (E) carry out informational and educational 
                activities in accordance with subsection (e);
                    (F) at least annually update information to 
                account for changes in the status of 
                individuals as potential donors of bone marrow;
                    (G) provide for a system of patient 
                advocacy through the office established under 
                subsection (h);
                    (H) provide case management services for 
                any potential donor of bone marrow to whom the 
                Program has provided a notice that the 
                potential donor may be suitably matched to a 
                particular patient through the office 
                established under subsection (h);
                    (I) with respect to searches for unrelated 
                donors of bone marrow that are conducted 
                through the system under subparagraph (A), 
                collect, analyze, and publish data in a 
                standardized electronic format on the number 
                and percentage of patients at each of the 
                various stages of the search process, including 
                data regarding the furthest stage reached, the 
                number and percentage of patients who are 
                unable to complete the search process, and the 
                reasons underlying such circumstances;
                    (J) support studies and demonstration and 
                outreach projects for the purpose of increasing 
                the number of individuals who are willing to be 
                marrow donors to ensure a genetically diverse 
                donor pool; and
                    (K) facilitate research with the 
                appropriate Federal agencies to improve the 
                availability, efficiency, safety, and cost of 
                transplants from unrelated donors and the 
                effectiveness of Program operations.
            (2) Cord blood functions.--With respect to cord 
        blood, the Program shall--
                    (A) operate a system for identifying, 
                matching, and facilitating the distribution of 
                donated cord blood units that are suitably 
                matched to candidate patients and meet all 
                applicable Federal and State regulations 
                (including informed consent and Food and Drug 
                Administration regulations) from a qualified 
                cord blood bank;
                    (B) consistent with paragraph (3), allow 
                transplant physicians, other appropriate health 
                care professionals, and patients to search by 
                means of electronic access all available cord 
                blood units made available through the Program;
                    (C) allow transplant physicians and other 
                appropriate health care professionals to 
                reserve, as defined by the Secretary, a cord 
                blood unit for transplantation;
                    (D) support studies and demonstration and 
                outreach projects for the purpose of increasing 
                cord blood donation to ensure a genetically 
                diverse collection of cord blood units;
                    (E) provide for a system of patient 
                advocacy through the office established under 
                subsection (h);
                    (F) coordinate with the qualified cord 
                blood banks to support informational and 
                educational activities in accordance with 
                subsection (g);
                    (G) maintain and expand medical contingency 
                response capabilities, in coordination with 
                Federal programs, to prepare for and respond 
                effectively to biological, chemical, or 
                radiological attacks, and other public health 
                emergencies that can damage marrow, so that the 
                capability of supporting patients with marrow 
                damage from disease can be used to support 
                casualties with marrow damage; and
                    (H) with respect to the system under 
                subparagraph (A), collect, analyze, and publish 
                data in a standardized electronic format, as 
                required by the Secretary, on the number and 
                percentage of patients at each of the various 
                stages of the search process, including data 
                regarding the furthest stage reached, the 
                number and percentage of patients who are 
                unable to complete the search process, and the 
                reasons underlying such circumstances.
            (3) Single point of access; standard data.--
                    (A) Single point of access.--The Secretary 
                shall ensure that health care professionals and 
                patients are able to search electronically for 
                and facilitate access to, in the manner and to 
                the extent defined by the Secretary and 
                consistent with the functions described in 
                paragraphs (1)(A) and (2)(A), cells from bone 
                marrow donors and cord blood units through a 
                single point of access.
                    (B) Standard data.--The Secretary shall 
                require all recipients of contracts under this 
                section to make available a standard dataset 
                for purposes of subparagraph (A) in a 
                standardized electronic format that enables 
                transplant physicians to compare among and 
                between bone marrow donors and cord blood units 
                to ensure the best possible match for the 
                patient.
            (4) Definition.--The term ``qualified cord blood 
        bank'' means a cord blood bank that--
                    (A) has obtained all applicable Federal and 
                State licenses, certifications, registrations 
                (including pursuant to the regulations of the 
                Food and Drug Administration), and other 
                authorizations required to operate and maintain 
                a cord blood bank;
                    (B) has implemented donor screening, cord 
                blood collection practices, and processing 
                methods intended to protect the health and 
                safety of donors and transplant recipients to 
                improve transplant outcomes, including with 
                respect to the transmission of potentially 
                harmful infections and other diseases;
                    (C) is accredited by an accreditation 
                entity recognized by the Secretary under 
                subsection (b);
                    (D) has established a system of strict 
                confidentiality to protect the identity and 
                privacy of patients and donors in accordance 
                with existing Federal and State law;
                    (E) has established a system for 
                encouraging donation by a genetically diverse 
                group of donors; and
                    (F) has established a system to 
                confidentially maintain linkage between a cord 
                blood unit and a maternal donor.
    (e) Bone Marrow Recruitment; Priorities; Information and 
Education.--
            (1) Recruitment; priorities.--The Program shall 
        carry out activities for the recruitment of bone marrow 
        donors. Such recruitment program shall identify 
        populations that are underrepresented among potential 
        donors enrolled with the Program. In the case of 
        populations that are identified under the preceding 
        sentence:
                    (A) The Program shall give priority to 
                carrying out activities under this part to 
                increase representation for such populations in 
                order to enable a member of such a population, 
                to the extent practicable, to have a 
                probability of finding a suitable unrelated 
                donor that is comparable to the probability 
                that an individual who is not a member of an 
                underrepresented population would have.
                    (B) The Program shall consider racial and 
                ethnic minority groups (including persons of 
                mixed ancestry) to be populations that have 
                been identified for purposes of this paragraph, 
                and shall carry out subparagraph (A) with 
                respect to such populations.
            (2) Information and education regarding 
        recruitment; testing and enrollment.--
                    (A) In general.--The Program shall carry 
                out informational and educational activities, 
                in coordination with organ donation public 
                awareness campaigns operated through the 
                Department of Health and Human Services, for 
                purposes of recruiting individuals to serve as 
                donors of bone marrow, and shall test and 
                enroll with the Program potential bone marrow 
                donors. Such information and educational 
                activities shall include the following:
                            (i) Making information available to 
                        the general public, including 
                        information describing the needs of 
                        patients with respect to donors of bone 
                        marrow.
                            (ii) Educating and providing 
                        information to individuals who are 
                        willing to serve as potential bone 
                        marrow donors.
                            (iii) Training individuals in 
                        requesting individuals to serve as 
                        potential bone marrow donors.
                    (B) Priorities.--In carrying out 
                informational and educational activities under 
                subparagraph (A), the Program shall give 
                priority to recruiting individuals to serve as 
                donors of bone marrow for populations that are 
                identified under paragraph (1).
            (3) Transplantation as treatment option.--In 
        addition to activities regarding recruitment, the 
        recruitment program under paragraph (1) shall provide 
        information to physicians, other health care 
        professionals, and the public regarding bone marrow 
        transplants from unrelated donors as a treatment 
        option.
            (4) Implementation of subsection.--The requirements 
        of this subsection shall be carried out by the entity 
        that has been awarded a contract by the Secretary under 
        subsection (a) to carry out the functions described in 
        subsection (d)(1).
    (f) Bone Marrow Criteria, Standards, and Procedures.--The 
Secretary shall enforce, for participating entities, including 
the Program, individual marrow donor centers, marrow donor 
registries, marrow collection centers, and marrow transplant 
centers--
            (1) quality standards and standards for tissue 
        typing, obtaining the informed consent of donors, and 
        providing patient advocacy;
            (2) donor selection criteria, based on established 
        medical criteria, to protect both the donor and the 
        recipient and to prevent the transmission of 
        potentially harmful infectious diseases such as the 
        viruses that cause hepatitis and the etiologic agent 
        for Acquired Immune Deficiency Syndrome;
            (3) procedures to ensure the proper collection and 
        transportation of the marrow;
            (4) standards for the system for patient advocacy 
        operated under subsection (h), including standards 
        requiring the provision of appropriate information (at 
        the start of the search process and throughout the 
        process) to patients and their families and physicians;
            (5) standards that--
                    (A) require the establishment of a system 
                of strict confidentiality of records relating 
                to the identity, address, HLA type, and 
                managing marrow donor center for marrow donors 
                and potential marrow donors; and
                    (B) prescribe the purposes for which the 
                records described in subparagraph (A) may be 
                disclosed, and the circumstances and extent of 
                the disclosure; and
            (6) in the case of a marrow donor center or marrow 
        donor registry participating in the program, procedures 
        to ensure the establishment of a method for integrating 
        donor files, searches, and general procedures of the 
        center or registry with the Program.
    (g) Cord Blood Recruitment; Priorities; Information and 
Education.--
            (1) Recruitment; priorities.--The Program shall 
        support activities, in cooperation with qualified cord 
        blood banks, for the recruitment of cord blood donors. 
        Such recruitment program shall identify populations 
        that are underrepresented among cord blood donors. In 
        the case of populations that are identified under the 
        preceding sentence:
                    (A) The Program shall give priority to 
                supporting activities under this part to 
                increase representation for such populations in 
                order to enable a member of such a population, 
                to the extent practicable, to have a 
                probability of finding a suitable cord blood 
                unit that is comparable to the probability that 
                an individual who is not a member of an 
                underrepresented population would have.
                    (B) The Program shall consider racial and 
                ethnic minority groups (including persons of 
                mixed ancestry) to be populations that have 
                been identified for purposes of this paragraph, 
                and shall support activities under subparagraph 
                (A) with respect to such populations.
            (2) Information and education regarding 
        recruitment; testing and donation.--
                    (A) In general.--In carrying out the 
                recruitment program under paragraph (1), the 
                Program shall support informational and 
                educational activities in coordination with 
                qualified cord blood banks and organ donation 
                public awareness campaigns operated through the 
                Department of Health and Human Services, for 
                purposes of recruiting pregnant women to serve 
                as donors of cord blood. Such information and 
                educational activities shall include the 
                following:
                            (i) Making information available to 
                        the general public, including 
                        information describing the needs of 
                        patients with respect to cord blood 
                        units.
                            (ii) Educating and providing 
                        information to pregnant women who are 
                        willing to donate cord blood units.
                            (iii) Training individuals in 
                        requesting pregnant women to serve as 
                        cord blood donors.
                    (B) Priorities.--In carrying out 
                informational and educational activities under 
                subparagraph (A), the Program shall give 
                priority to supporting the recruitment of 
                pregnant women to serve as donors of cord blood 
                for populations that are identified under 
                paragraph (1).
            (3) Transplantation as treatment option.--In 
        addition to activities regarding recruitment, the 
        recruitment program under paragraph (1) shall provide 
        information to physicians, other health care 
        professionals, and the public regarding cord blood 
        transplants from donors as a treatment option.
            (4) Implementation of subsection.--The requirements 
        of this subsection shall be carried out by the entity 
        that has been awarded a contract by the Secretary under 
        subsection (a) to carry out the functions described in 
        subsection (d)(2).
    (h) Patient Advocacy and Case Management for Bone Marrow 
and Cord Blood.--
            (1) In general.--The Secretary shall establish and 
        maintain, through a contract or other means determined 
        appropriate by the Secretary, an office of patient 
        advocacy (in this subsection referred to as the 
        ``Office'').
            (2) General functions.--The Office shall meet the 
        following requirements:
                    (A) The Office shall be headed by a 
                director.
                    (B) The Office shall be staffed by 
                individuals with expertise in bone marrow and 
                cord blood therapy covered under the Program.
                    (C) The Office shall operate a system for 
                patient advocacy, which shall be separate from 
                mechanisms for donor advocacy, and which shall 
                serve patients for whom the Program is 
                conducting, or has been requested to conduct, a 
                search for a bone marrow donor or cord blood 
                unit.
                    (D) In the case of such a patient, the 
                Office shall serve as an advocate for the 
                patient by directly providing to the patient 
                (or family members, physicians, or other 
                individuals acting on behalf of the patient) 
                individualized services with respect to 
                efficiently utilizing the system under 
                paragraphs (1) and (2) of subsection (d) to 
                conduct an ongoing search for a bone marrow 
                donor or cord blood unit and assist with 
                information regarding third party payor 
                matters.
                    (E) In carrying out subparagraph (D), the 
                Office shall monitor the system under 
                paragraphs (1) and (2) of subsection (d) to 
                determine whether the search needs of the 
                patient involved are being met, including with 
                respect to the following:
                            (i) Periodically providing to the 
                        patient (or an individual acting on 
                        behalf of the patient) information 
                        regarding bone marrow donors or cord 
                        blood units that are suitably matched 
                        to the patient, and other information 
                        regarding the progress being made in 
                        the search.
                            (ii) Informing the patient (or such 
                        other individual) if the search has 
                        been interrupted or discontinued.
                            (iii) Identifying and resolving 
                        problems in the search, to the extent 
                        practicable.
                    (F) The Office shall ensure that the 
                following data are made available to patients:
                            (i) The resources available through 
                        the Program.
                            (ii) A comparison of transplant 
                        centers regarding search and other 
                        costs that prior to transplantation are 
                        charged to patients by transplant 
                        centers.
                            (iii) The post-transplant outcomes 
                        for individual transplant centers.
                            (iv) Information concerning issues 
                        that patients may face after a 
                        transplant.
                            (v) Such other information as the 
                        Program determines to be appropriate.
                    (G) The Office shall conduct surveys of 
                patients (or family members, physicians, or 
                other individuals acting on behalf of patients) 
                to determine the extent of satisfaction with 
                the system for patient advocacy under this 
                subsection, and to identify ways in which the 
                system can be improved to best meet the needs 
                of patients.
            (3) Case management.--
                    (A) In general.--In serving as an advocate 
                for a patient under paragraph (2), the Office 
                shall provide individualized case management 
                services directly to the patient (or family 
                members, physicians, or other individuals 
                acting on behalf of the patient), including--
                            (i) individualized case assessment; 
                        and
                            (ii) the functions described in 
                        paragraph (2)(D) (relating to progress 
                        in the search process).
                    (B) Postsearch functions.--In addition to 
                the case management services described in 
                paragraph (1) for patients, the Office shall, 
                on behalf of patients who have completed the 
                search for a bone marrow donor or cord blood 
                unit, provide information and education on the 
                process of receiving a transplant, including 
                the post-transplant process.
    (i) Comment Procedures.--The Secretary shall establish and 
provide information to the public on procedures under which the 
Secretary shall receive and consider comments from interested 
persons relating to the manner in which the Program is carrying 
out the duties of the Program. The Secretary may promulgate 
regulations under this section.
    (j) Consultation.--In developing policies affecting the 
Program, the Secretary shall consult with the Advisory Council, 
the Department of Defense Marrow Donor Recruitment and Research 
Program operated by the Department of the Navy, and the board 
of directors of each entity awarded a contract under this 
section.
    (k) Contracts.--
            (1) Application.--To be eligible to enter into a 
        contract under this section, an entity shall submit to 
        the Secretary and obtain approval of an application at 
        such time, in such manner, and containing such 
        information as the Secretary shall by regulation 
        prescribe.
            (2) Considerations.--In awarding contracts under 
        this section, the Secretary shall give consideration to 
        the continued safety of donors and patients and other 
        factors deemed appropriate by the Secretary.
    (l) Eligibility.--Entities eligible to receive a contract 
under this section shall include private nonprofit entities.
    (m) Records.--
            (1) Recordkeeping.--Each recipient of a contract or 
        subcontract under subsection (a) shall keep such 
        records as the Secretary shall prescribe, including 
        records that fully disclose the amount and disposition 
        by the recipient of the proceeds of the contract, the 
        total cost of the undertaking in connection with which 
        the contract was made, and the amount of the portion of 
        the cost of the undertaking supplied by other sources, 
        and such other records as will facilitate an effective 
        audit.
            (2) Examination of records.--The Secretary and the 
        Comptroller General of the United States shall have 
        access to any books, documents, papers, and records of 
        the recipient of a contract or subcontract entered into 
        under this section that are pertinent to the contract, 
        for the purpose of conducting audits and examinations.
    (n) Penalties for Disclosure.--Any person who discloses the 
content of any record referred to in subsection (d)(4)(D) or 
(f)(5)(A) without the prior written consent of the donor or 
potential donor with respect to whom the record is maintained, 
or in violation of the standards described in subsection 
(f)(5)(B), shall be imprisoned for not more than 2 years or 
fined in accordance with title 18, United States Code, or both.

SEC. 379A. [274L] STEM CELL THERAPEUTIC OUTCOMES DATABASE.

    (a) Establishment.--The Secretary shall by contract 
establish and maintain a scientific database of information 
relating to patients who have been recipients of a stem cell 
therapeutics product (including bone marrow, cord blood, or 
other such product) from a donor.
    (b) Information.--The outcomes database shall include 
information in a standardized electronic format with respect to 
patients described in subsection (a), diagnosis, transplant 
procedures, results, long-term follow-up, and such other 
information as the Secretary determines to be appropriate, to 
conduct an ongoing evaluation of the scientific and clinical 
status of transplantation involving recipients of a stem cell 
therapeutics product from a donor.
    (c) Annual Report on Patient Outcomes.--The Secretary shall 
require the entity awarded a contract under this section to 
submit to the Secretary an annual report concerning patient 
outcomes with respect to each transplant center, based on data 
collected and maintained by the entity pursuant to this 
section.
    (d) Publicly Available Data.--The outcomes database shall 
make relevant scientific information not containing 
individually identifiable information available to the public 
in the form of summaries and data sets to encourage medical 
research and to provide information to transplant programs, 
physicians, patients, entities awarded a contract under section 
379 donor registries, and cord blood banks.

SEC. 379A-1. [274L-1] DEFINITIONS.

    In this part:
            (1) The term ``Advisory Council'' means the 
        advisory council established by the Secretary under 
        section 379(a)(1).
            (2) The term ``bone marrow'' means the cells found 
        in adult bone marrow and peripheral blood.
            (3) The term ``outcomes database'' means the 
        database established by the Secretary under section 
        379A.
            (4) The term ``Program'' means the C.W. Bill Young 
        Cell Transplantation Program established under section 
        379.

SEC. 379B. [274M] AUTHORIZATION OF APPROPRIATIONS.

    For the purpose of carrying out this part, there are 
authorized to be appropriated $34,000,000 for fiscal year 2006 
and $38,000,000 for each of fiscal years 2007 through 2010.

               Part J--Prevention and Control of Injuries

                                research
    Sec. 391. [280b] (a) The Secretary, through the Director of 
the Centers for Disease Control and Prevention, shall--
            (1) conduct, and give assistance to public and 
        nonprofit private entities, scientific institutions, 
        and individuals engaged in the conduct of, research 
        relating to the causes, mechanisms, prevention, 
        diagnosis, treatment of injuries, and rehabilitation 
        from injuries;
            (2) make grants to, or enter into cooperative 
        agreements or contracts with, public and nonprofit 
        private entities (including academic institutions, 
        hospitals, and laboratories) and individuals for the 
        conduct of such research; and
            (3) make grants to, or enter into cooperative 
        agreements or contracts with, academic institutions for 
        the purpose of providing training on the causes, 
        mechanisms, prevention, diagnosis, treatment of 
        injuries, and rehabilitation from injuries.
    (b) The Secretary, through the Director of the Centers for 
Disease Control and Prevention, shall collect and disseminate, 
through publications and other appropriate means, information 
concerning the practical applications of research conducted or 
assisted under subsection (a). In carrying out the preceding 
sentence, the Secretary shall disseminate such information to 
the public, including through elementary and secondary schools.
                   prevention and control activities
    Sec. 392. [280b-1] (a) The Secretary, through the Director 
of the Centers for Disease Control and Prevention, shall--
            (1) assist States and political subdivisions of 
        States in activities for the prevention and control of 
        injuries; and
            (2) encourage regional activities between States 
        designed to reduce injury rates.
    (b) The Secretary, through the Director of the Centers for 
Disease Control and Prevention, may--
            (1) enter into agreements between the Service and 
        public and private community health agencies which 
        provide for cooperative planning of activities to deal 
        with problems relating to the prevention and control of 
        injuries;
            (2) work in cooperation with other Federal 
        agencies, and with public and nonprofit private 
        entities, to promote activities regarding the 
        prevention and control of injuries; and
            (3) make grants to States and, after consultation 
        with State health agencies, to other public or 
        nonprofit private entities for the purpose of carrying 
        out demonstration projects for the prevention and 
        control of injuries at sites that are not subject to 
        the Occupational Safety and Health Act of 1970, 
        including homes, elementary and secondary schools, and 
        public buildings.
     interpersonal violence within families and among acquaintances
    Sec. 393. [280b-1a] (a) With respect to activities that are 
authorized in sections 391 and 392, the Secretary, acting 
through the Director of the Centers for Disease Control and 
Prevention, shall carry out such activities with respect to 
interpersonal violence within families and among acquaintances. 
Activities authorized in the preceding sentence include the 
following:
            (1) Collecting data relating to the incidence of 
        such violence.
            (2) Making grants to public and nonprofit private 
        entities for the evaluation of programs whose purpose 
        is to prevent such violence, including the evaluation 
        of demonstration projects under paragraph (6).
            (3) Making grants to public and nonprofit private 
        entities for the conduct of research on identifying 
        effective strategies for preventing such violence.
            (4) Providing to the public information and 
        education on such violence, including information and 
        education to increase awareness of the public health 
        consequences of such violence.
            (5) Training health care providers as follows:
                    (A) To identify individuals whose medical 
                conditions or statements indicate that the 
                individuals are victims of such violence.
                    (B) To routinely determine, in examining 
                patients, whether the medical conditions or 
                statements of the patients so indicate.
                    (C) To refer individuals so identified to 
                entities that provide services regarding such 
                violence, including referrals for counseling, 
                housing, legal services, and services of 
                community organizations.
            (6) Making grants to public and nonprofit private 
        entities for demonstration projects with respect to 
        such violence, including with respect to prevention.
    (b) For purposes of this part, the term ``interpersonal 
violence within families and among acquaintances'' includes 
behavior commonly referred to as domestic violence, sexual 
assault, spousal abuse, woman battering, partner abuse, elder 
abuse, and acquaintance rape.check usc citations for 
sections 393A and 393B which were renumbered by section 2(1) 
and (2) of PL 110-206 deg.

SEC. 393A. [280B-1B] USE OF ALLOTMENTS FOR RAPE PREVENTION EDUCATION.

    (a) Permitted Use.--The Secretary, acting through the 
National Center for Injury Prevention and Control at the 
Centers for Disease Control and Prevention, shall award 
targeted grants to States to be used for rape prevention and 
education programs conducted by rape crisis centers, State 
sexual assault coalitions, and other public and private 
nonprofit entities for--
            (1) educational seminars;
            (2) the operation of hotlines;
            (3) training programs for professionals;
            (4) the preparation of informational material;
            (5) education and training programs for students 
        and campus personnel designed to reduce the incidence 
        of sexual assault at colleges and universities;
            (6) education to increase awareness about drugs 
        used to facilitate rapes or sexual assaults; and
            (7) other efforts to increase awareness of the 
        facts about, or to help prevent, sexual assault, 
        including efforts to increase awareness in underserved 
        communities and awareness among individuals with 
        disabilities (as defined in section 3 of the Americans 
        with Disabilities Act of 1990 (42 U.S.C. 12102)).
    (b) Collection and Dissemination of Information on Sexual 
Assault.--The Secretary shall, through the National Resource 
Center on Sexual Assault established under the National Center 
for Injury Prevention and Control at the Centers for Disease 
Control and Prevention, provide resource information, policy, 
training, and technical assistance to Federal, State, local, 
and Indian tribal agencies, as well as to State sexual assault 
coalitions and local sexual assault programs and to other 
professionals and interested parties on issues relating to 
sexual assault, including maintenance of a central resource 
library in order to collect, prepare, analyze, and disseminate 
information and statistics and analyses thereof relating to the 
incidence and prevention of sexual assault.
    (c) Authorization of Appropriations.--
            (1) In general.--There is authorized to be 
        appropriated to carry out this section $80,000,000 for 
        each of fiscal years 2007 through 2011.
            (2) National sexual violence resource center 
        allotment.--Of the total amount made available under 
        this subsection in each fiscal year, not less than 
        $1,500,000 shall be available for allotment under 
        subsection (b).
    (d) Limitations.--
            (1) Supplement not supplant.--Amounts provided to 
        States under this section shall be used to supplement 
        and not supplant other Federal, State, and local public 
        funds expended to provide services of the type 
        described in subsection (a).
            (2) Studies.--A State may not use more than 2 
        percent of the amount received by the State under this 
        section for each fiscal year for surveillance studies 
        or prevalence studies.
            (3) Administration.--A State may not use more than 
        5 percent of the amount received by the State under 
        this section for each fiscal year for administrative 
        expenses.
                  prevention of traumatic brain injury
    Sec. 393B. [280b-1c] (a) In General.--The Secretary, acting 
through the Director of the Centers for Disease Control and 
Prevention, may carry out projects to reduce the incidence of 
traumatic brain injury. Such projects may be carried out by the 
Secretary directly or through awards of grants or contracts to 
public or nonprofit private entities. The Secretary may 
directly or through such awards provide technical assistance 
with respect to the planning, development, and operation of 
such projects.
    (b) Certain Activities.--Activities under subsection (a) 
may include--
            (1) the conduct of research into identifying 
        effective strategies for the prevention of traumatic 
        brain injury;
            (2) the implementation of public information and 
        education programs for the prevention of such injury 
        and for broadening the awareness of the public 
        concerning the public health consequences of such 
        injury; and
            (3) the implementation of a national education and 
        awareness campaign regarding such injury (in 
        conjunction with the program of the Secretary regarding 
        health-status goals for 2010, commonly referred to as 
        Healthy People 2010), including--
                    (A) the national dissemination of 
                information on--
                            (i) incidence and prevalence; and
                            (ii) information relating to 
                        traumatic brain injury and the sequelae 
                        of secondary conditions arising from 
                        traumatic brain injury upon discharge 
                        from hospitals and emergency 
                        departments; and
                    (B) the provision of information in primary 
                care settings, including emergency rooms and 
                trauma centers, concerning the availability of 
                State level services and resources.
    (c) Coordination of Activities.--The Secretary shall ensure 
that activities under this section are coordinated as 
appropriate with other agencies of the Public Health Service 
that carry out activities regarding traumatic brain injury.
    (d) Definition.--For purposes of this section, the term 
``traumatic brain injury'' means an acquired injury to the 
brain. Such term does not include brain dysfunction caused by 
congenital or degenerative disorders, nor birth trauma, but may 
include brain injuries caused by anoxia due to trauma. The 
Secretary may revise the definition of such term as the 
Secretary determines necessary, after consultation with States 
and other appropriate public or nonprofit private entities.
national program for traumatic brain injury surveillance and registries
    Sec. 393C. \1\ [280b-1d] (a) In General.--The Secretary, 
acting through the Director of the Centers for Disease Control 
and Prevention, may make grants to States or their designees to 
develop or operate the State's traumatic brain injury 
surveillance system or registry to determine the incidence and 
prevalence of traumatic brain injury and related disability, to 
ensure the uniformity of reporting under such system or 
registry, to link individuals with traumatic brain injury to 
services and supports, and to link such individuals with 
academic institutions to conduct applied research that will 
support the development of such surveillance systems and 
registries as may be necessary. A surveillance system or 
registry under this section shall provide for the collection of 
data concerning--
---------------------------------------------------------------------------
    \1\ The amendment by section 2(3) of Public Law 110-206 to 
redesignate section 393B (relating to traumatic brain injury 
registeries) as section 393C could not be executed because such section 
had already been redesignated as section 393C by section 2(1) of Public 
Law 110-202.
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            (1) demographic information about each traumatic 
        brain injury;
            (2) information about the circumstances surrounding 
        the injury event associated with each traumatic brain 
        injury;
            (3) administrative information about the source of 
        the collected information, dates of hospitalization and 
        treatment, and the date of injury; and
            (4) information characterizing the clinical aspects 
        of the traumatic brain injury, including the severity 
        of the injury, outcomes of the injury, the types of 
        treatments received, and the types of services 
        utilized.
    (b) Not later than 18 months after the date of enactment of 
the Traumatic Brain Injury Act of 2008, the Secretary, acting 
through the Director of the Centers for Disease Control and 
Prevention and the Director of the National Institutes of 
Health and in consultation with the Secretary of Defense and 
the Secretary of Veterans Affairs, shall submit to the relevant 
committees of Congress a report that contains the findings 
derived from an evaluation concerning activities and procedures 
that can be implemented by the Centers for Disease Control and 
Prevention to improve the collection and dissemination of 
compatible epidemiological studies on the incidence and 
prevalence of traumatic brain injury in individuals who were 
formerly in the military. The report shall include 
recommendations on the manner in which such agencies can 
further collaborate on the development and improvement of 
traumatic brain injury diagnostic tools and treatments.

SEC. 393C-1. [280B-1E] STUDY ON TRAUMATIC BRAIN INJURY.

    (a) Study.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention with respect to 
paragraph (1) and in consultation with the Director of the 
National Institutes of Health and other appropriate entities 
with respect to paragraphs (2), (3), and (4), may conduct a 
study with respect to traumatic brain injury for the purpose of 
carrying out the following:
            (1) In collaboration with appropriate State and 
        local health-related agencies--
                    (A) determining the incidence of traumatic 
                brain injury and prevalence of traumatic brain 
                injury related disability and the clinical 
                aspects of the disability in all age groups and 
                racial and ethnic minority groups in the 
                general population of the United States, 
                including institutional settings, such as 
                nursing homes, correctional facilities, 
                psychiatric hospitals, child care facilities, 
                and residential institutes for people with 
                developmental disabilities; and
                    (B) reporting national trends in traumatic 
                brain injury.
            (2) Identifying common therapeutic interventions 
        which are used for the rehabilitation of individuals 
        with such injuries, and, subject to the availability of 
        information, including an analysis of--
                    (A) the effectiveness of each such 
                intervention in improving the functioning, 
                including return to work or school and 
                community participation, of individuals with 
                brain injuries;
                    (B) the comparative effectiveness of 
                interventions employed in the course of 
                rehabilitation of individuals with brain 
                injuries to achieve the same or similar 
                clinical outcome; and
                    (C) the adequacy of existing measures of 
                outcomes and knowledge of factors influencing 
                differential outcomes.
            (3) Identifying interventions and therapies that 
        can prevent or remediate the development of secondary 
        neurologic conditions related to traumatic brain 
        injury.
            (4) Developing practice guidelines for the 
        rehabilitation of traumatic brain injury at such time 
        as appropriate scientific research becomes available.
    (b) Dates Certain for Reports.--If the study is conducted 
under subsection (a), the Secretary shall, not later than 3 
years after the date of the enactment of the Traumatic Brain 
Injury Act of 2008, submit to Congress a report describing 
findings made as a result of carrying out such subsection (a).
    (c) Definition.--For purposes of this section, the term 
``traumatic brain injury'' means an acquired injury to the 
brain. Such term does not include brain dysfunction caused by 
congenital or degenerative disorders, nor birth trauma, but may 
include brain injuries caused by anoxia due to trauma including 
near drowning. The Secretary may revise the definition of such 
term as the Secretary determines necessary.

SEC. 393D. [28B-1F] PREVENTION OF FALLS AMONG OLDER ADULTS.

    (a) Public Education.--The Secretary may--
            (1) oversee and support a national education 
        campaign to be carried out by a nonprofit organization 
        with experience in designing and implementing national 
        injury prevention programs, that is directed 
        principally to older adults, their families, and health 
        care providers, and that focuses on reducing falls 
        among older adults and preventing repeat falls; and
            (2) award grants, contracts, or cooperative 
        agreements to qualified organizations, institutions, or 
        consortia of qualified organizations and institutions, 
        specializing, or demonstrating expertise, in falls or 
        fall prevention, for the purpose of organizing State-
        level coalitions of appropriate State and local 
        agencies, safety, health, senior citizen, and other 
        organizations to design and carry out local education 
        campaigns, focusing on reducing falls among older 
        adults and preventing repeat falls.
    (b) Research.--
            (1) In general.--The Secretary may--
                    (A) conduct and support research to--
                            (i) improve the identification of 
                        older adults who have a high risk of 
                        falling;
                            (ii) improve data collection and 
                        analysis to identify fall risk and 
                        protective factors;
                            (iii) design, implement, and 
                        evaluate the most effective fall 
                        prevention interventions;
                            (iv) improve strategies that are 
                        proven to be effective in reducing 
                        falls by tailoring these strategies to 
                        specific populations of older adults;
                            (v) conduct research in order to 
                        maximize the dissemination of proven, 
                        effective fall prevention 
                        interventions;
                            (vi) intensify proven interventions 
                        to prevent falls among older adults;
                            (vii) improve the diagnosis, 
                        treatment, and rehabilitation of 
                        elderly fall victims and older adults 
                        at high risk for falls; and
                            (viii) assess the risk of falls 
                        occurring in various settings;
                    (B) conduct research concerning barriers to 
                the adoption of proven interventions with 
                respect to the prevention of falls among older 
                adults;
                    (C) conduct research to develop, implement, 
                and evaluate the most effective approaches to 
                reducing falls among high-risk older adults 
                living in communities and long-term care and 
                assisted living facilities; and
                    (D) evaluate the effectiveness of community 
                programs designed to prevent falls among older 
                adults.
            (2) Educational support.--The Secretary, either 
        directly or through awarding grants, contracts, or 
        cooperative agreements to qualified organizations, 
        institutions, or consortia of qualified organizations 
        and institutions, specializing, or demonstrating 
        expertise, in falls or fall prevention, may provide 
        professional education for physicians and allied health 
        professionals, and aging service providers in fall 
        prevention, evaluation, and management.
    (c) Demonstration Projects.--The Secretary may carry out 
the following:
            (1) Oversee and support demonstration and research 
        projects to be carried out by qualified organizations, 
        institutions, or consortia of qualified organizations 
        and institutions, specializing, or demonstrating 
        expertise, in falls or fall prevention, in the 
        following areas:
                    (A) A multistate demonstration project 
                assessing the utility of targeted fall risk 
                screening and referral programs.
                    (B) Programs designed for community-
                dwelling older adults that utilize 
                multicomponent fall intervention approaches, 
                including physical activity, medication 
                assessment and reduction when possible, vision 
                enhancement, and home modification strategies.
                    (C) Programs that are targeted to new fall 
                victims who are at a high risk for second falls 
                and which are designed to maximize independence 
                and quality of life for older adults, 
                particularly those older adults with functional 
                limitations.
                    (D) Private sector and public-private 
                partnerships to develop technologies to prevent 
                falls among older adults and prevent or reduce 
                injuries if falls occur.
            (2)(A) Award grants, contracts, or cooperative 
        agreements to qualified organizations, institutions, or 
        consortia of qualified organizations and institutions, 
        specializing, or demonstrating expertise, in falls or 
        fall prevention, to design, implement, and evaluate 
        fall prevention programs using proven intervention 
        strategies in residential and institutional settings.
            (B) Award 1 or more grants, contracts, or 
        cooperative agreements to 1 or more qualified 
        organizations, institutions, or consortia of qualified 
        organizations and institutions, specializing, or 
        demonstrating expertise, in falls or fall prevention, 
        in order to carry out a multistate demonstration 
        project to implement and evaluate fall prevention 
        programs using proven intervention strategies designed 
        for single and multifamily residential settings with 
        high concentrations of older adults, including--
                    (i) identifying high-risk populations;
                    (ii) evaluating residential facilities;
                    (iii) conducting screening to identify 
                high-risk individuals;
                    (iv) providing fall assessment and risk 
                reduction interventions and counseling;
                    (v) coordinating services with health care 
                and social service providers; and
                    (vi) coordinating post-fall treatment and 
                rehabilitation.
            (3) Award 1 or more grants, contracts, or 
        cooperative agreements to qualified organizations, 
        institutions, or consortia of qualified organizations 
        and institutions, specializing, or demonstrating 
        expertise, in falls or fall prevention, to conduct 
        evaluations of the effectiveness of the demonstration 
        projects described in this subsection.
    (d) Priority.--In awarding grants, contracts, or 
cooperative agreements under this section, the Secretary may 
give priority to entities that explore the use of cost-sharing 
with respect to activities funded under the grant, contract, or 
agreement to ensure the institutional commitment of the 
recipients of such assistance to the projects funded under the 
grant, contract, or agreement. Such non-Federal cost sharing 
contributions may be provided directly or through donations 
from public or private entities and may be in cash or in-kind, 
fairly evaluated, including plant, equipment, or services.
    (e) Study of Effects of Falls on Health Care Costs.--
            (1) In general.--The Secretary may conduct a review 
        of the effects of falls on health care costs, the 
        potential for reducing falls, and the most effective 
        strategies for reducing health care costs associated 
        with falls.
            (2) Report.--If the Secretary conducts the review 
        under paragraph (1), the Secretary shall, not later 
        than 36 months after the date of enactment of the 
        Safety of Seniors Act of 2007, submit to Congress a 
        report describing the findings of the Secretary in 
        conducting such review.
                           general provisions
    Sec. 394. [280b-2] (a) The Secretary, acting through the 
Director of the Centers for Disease Control and Prevention, 
shall establish an advisory committee to advise the Secretary 
and such Director with respect to the prevention and control of 
injuries.
    (b) The Secretary, acting through the Director of the 
Centers for Disease Control and Prevention, may provide 
technical assistance to public and nonprofit private entities 
with respect to the planning, development, and operation of any 
program or service carried out pursuant to this part. The 
Secretary may provide such technical assistance directly or 
through grants or contracts.
    (c) Not later than February 1 of 1995 and of every second 
year thereafter, the Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, shall submit to 
the Committee on Energy and Commerce of the House of 
Representatives, and to the Committee on Labor and Human 
Resources of the Senate, a report describing the activities 
carried out under this part during the preceding 2 fiscal 
years. Such report shall include a description of such 
activities that were carried out with respect to interpersonal 
violence within families and among acquaintances and with 
respect to rural areas.
                    authorizations of appropriations
    Sec. 394A. [280b-3] For the purpose of carrying out this 
part, there are authorized to be appropriated $50,000,000 for 
fiscal year 1994, and \1\ such sums as may be necessary for 
each of the fiscal years 1995 through 1998, and such sums as 
may be necessary for each of the fiscal years 2001 through 
2005.. \1\
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    \1\ So in law. Section 1306 of Public Law 106-310 (114 Stat. 1143) 
attempts to strike ``and'', but the amendment cannot be executed 
because the instructions were to strike ``and'' after ``1994''. (The 
word ``and'' appears after ``1994,'', not ``1994''.) Such section 1306 
also added the superfluous period.
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                Part K--Health Care Services in the Home

              Subpart I--Grants for Demonstration Projects

SEC. 395. [280C] ESTABLISHMENT OF PROGRAM.

    (a) In General.--The Secretary, acting through the 
Administrator of the Health Resources and Services 
Administration, shall make not less than 5, and not more than 
20, grants to States for the purpose of assisting grantees in 
carrying out demonstration projects--
            (1) to identify low-income individuals who can 
        avoid institutionalization or prolonged hospitalization 
        if \2\ skilled nursing care services, homemaker or home 
        health aide services, or personal care services are 
        provided in the homes of the individuals;
---------------------------------------------------------------------------
    \2\ Section 2(f) of Public Law 102-108 (105 Stat. 550) provides as 
follows: ``(f) Public Health Service Act Technical Amendments.--Section 
395. [280c](a)(1) after the word `if' insert the words `skilled medical 
services,' ''. The text of such section 2(f) does not provide 
sufficient amendatory instructions to execute an amendment. The 
apparent intent of the Congress was to amend section 395(a)(1) of the 
Public Health Service Act (42 U.S.C. 280c(a)(1)).
---------------------------------------------------------------------------
            (2) to pay the costs of the provision of such 
        services in the homes of such individuals; and
            (3) to coordinate the provision by public and 
        private entities of such services, and other long-term 
        care services, in the homes of such individuals.
    (b) Requirement With Respect to Age of Recipients of 
Services.--The Secretary may not make a grant under subsection 
(a) to a State unless the State agrees to ensure that--
            (1) not less than 25 percent of the grant is 
        expended to provide services under such subsection to 
        individuals who are not less than 65 years of age; and
            (2) of the portion of the grant reserved by the 
        State for purposes of complying with paragraph (1), not 
        less than 10 percent is expended to provide such 
        services to individuals who are not less than 85 years 
        of age.
    (c) Relationship to Items and Services Under Other 
Programs.--A State may not make payments from a grant under 
subsection (a) for any item or service to the extent that 
payment has been made, or can reasonably be expected to be 
made, with respect to such item or service--
            (1) under any State compensation program, under an 
        insurance policy, or under any Federal or State health 
        benefits program; or
            (2) by an entity that provides health services on a 
        prepaid basis.

SEC. 396. [280C-1] LIMITATION ON DURATION OF GRANT AND REQUIREMENT OF 
                    MATCHING FUNDS.

    (a) Limitation on Duration of Grant.--The period during 
which payments are made to a State from a grant under section 
395(a) may not exceed 3 years. Such payments shall be subject 
to annual evaluation by the Secretary.
    (b) Requirement of Matching Funds.--
            (1)(A) For the first year of payments to a State 
        from a grant under section 395(a), the Secretary may 
        not make such payments in an amount exceeding 75 
        percent of the costs of services to be provided by the 
        State pursuant to such section.
            (B) For the second year of such payments to a 
        State, the Secretary may not make such payments in an 
        amount exceeding 65 percent of the costs of such 
        services.
            (C) For the third year of such payments to a State, 
        the Secretary may not make such payments in an amount 
        exceeding 55 percent of the costs of such services.
            (2) The Secretary may not make a grant under 
        section 395(a) to a State unless the State agrees to 
        make available, directly or through donations from 
        public or private entities, non-Federal contributions 
        toward the costs of services to be provided pursuant to 
        such section in an amount equal to--
                    (A) for the first year of payments to the 
                State from the grant, not less than $25 (in 
                cash or in kind under subsection (c)) for each 
                $75 of Federal funds provided in the grant;
                    (B) for the second year of such payments to 
                the State, not less than $35 (in cash or in 
                kind under subsection (c)) for each $65 of such 
                Federal funds; and
                    (C) for the third year of such payments to 
                the State, not less than $45 (in cash or in 
                kind under subsection (c)) for each $55 of such 
                Federal funds.
    (c) Determination of Amount of Non-Federal Contribution.--
Non-Federal contributions required in subsection (b) may be in 
cash or in kind, fairly evaluated, including plant, equipment, 
or services. Amounts provided by the Federal Government, or 
services assisted or subsidized to any significant extent by 
the Federal Government, may not be included in determining the 
amount of such non-Federal contributions.

SEC. 397. [280C-2] GENERAL PROVISIONS.

    (a) Limitation on Administrative Expenses.--The Secretary 
may not make a grant under section 395(a) to a State unless the 
State agrees that not more than 10 percent of the grant will be 
expended for administrative expenses with respect to the grant.
    (b) Description of Intended Use of Grant.--The Secretary 
may not make a grant under section 395(a) to a State unless--
            (1) the State submits to the Secretary a 
        description of the purposes for which the State intends 
        to expend the grant; and
            (2) such description provides information relating 
        to the programs and activities to be supported and 
        services to be provided, including--
                    (A) the number of individuals who will 
                receive services pursuant to section 395(a) and 
                the average costs of providing such services to 
                each such individual; and
                    (B) a description of the manner in which 
                such programs and activities will be 
                coordinated with any similar programs and 
                activities of public and private entities.
    (c) Requirement of Application.--The Secretary may not make 
a grant under section 395(a) to a State unless the State has 
submitted to the Secretary an application for the grant. The 
application shall--
            (1) contain the description of intended 
        expenditures required in subsection (b);
            (2) with respect to carrying out the purpose for 
        which the grant is to be made, provide assurances of 
        compliance satisfactory to the Secretary; and
            (3) otherwise be in such form, be made in such 
        manner, and contain such information and agreements as 
        the Secretary determines to be necessary to carry out 
        this subpart.
    (d) Evaluations and Report by Secretary.--The Secretary 
shall--
            (1) provide for an evaluation of each demonstration 
        project for which a grant is made under section 395(a); 
        and
            (2) not later than 6 months after the completion of 
        such evaluations, submit to the Congress a report 
        describing the findings made as a result of the 
        evaluations.
    (e) Authorizations of Appropriations.--For the purpose of 
carrying out this subpart, there are authorized to be 
appropriated $5,000,000 for each of the fiscal years 1988 
through 1990, $7,500,000 for fiscal year 1991, and such sums as 
may be necessary for each of the fiscal years 1992 and 1993.

    Subpart II--Grants for Demonstrations Projects With Respect to 
                          Alzheimer's Disease

SEC. 398. [280C-3] ESTABLISHMENT OF PROGRAM.

    (a) In General.--The Secretary shall make grants to States 
for the purpose of assisting grantees in carrying out 
demonstration projects for planning, establishing, and 
operating programs--
            (1) to coordinate the development and operation 
        with public and private organizations of diagnostic, 
        treatment, care management, respite care, legal 
        counseling, and education services provided within the 
        State to individuals with Alzheimer's disease or 
        related disorders and to the families and care 
        providers of such individuals;
            (2) to provide home health care, personal care, day 
        care, companion services, short-term care in health 
        facilities, and other respite care to individuals with 
        Alzheimer's disease or related disorders who are living 
        in single family homes or in congregate settings;
            (3) to improve the access of such individuals to 
        home-based or community-based long-term care services 
        (subject to the services being provided by entities 
        that were providing such services in the State involved 
        as of October 1, 1995), particularly such individuals 
        who are members of racial or ethnic minority groups, 
        who have limited proficiency in speaking the English 
        language, or who live in rural areas; and
            (4) to provide to health care providers, to 
        individuals with Alzheimer's disease or related 
        disorders, to the families of such individuals, to 
        organizations established for such individuals and such 
        families, and to the general public, information with 
        respect to--
                    (A) diagnostic services, treatment 
                services, and related services available to 
                such individuals and to the families of such 
                individuals;
                    (B) sources of assistance in obtaining such 
                services, including assistance under 
                entitlement programs; and
                    (C) the legal rights of such individuals 
                and such families.
    (b) Requirement With Respect to Certain Expenditures.--The 
Secretary may not make a grant under subsection (a) to a State 
unless the State agrees to expend not less than 50 percent of 
the grant for the provision of services described in subsection 
(a)(2).
    (c) Relationship to Items and Services Under Other 
Programs.--A State may not make payments from a grant under 
subsection (a) for any item or service to the extent that 
payment has been made, or can reasonably be expected to be 
made, with respect to such item or service--
            (1) under any State compensation program, under an 
        insurance policy, or under any Federal or State health 
        benefits program; or
            (2) by an entity that provides health services on a 
        prepaid basis.

SEC. 398A. [280C-4] REQUIREMENT OF MATCHING FUNDS \1\
---------------------------------------------------------------------------

    \1\ So in law. The section heading lacks a period. See section 
301(b)(1) of Public Law 105-392 (112 Stat. 3586).
---------------------------------------------------------------------------
    (a) Requirement of Matching Funds.--
            (1)(A) For the first year of payments to a State 
        from a grant under section 398(a), the Secretary may 
        not make such payments in an amount exceeding 75 
        percent of the costs of services to be provided by the 
        State pursuant to such section.
            (B) For the second year of such payments to a 
        State, the Secretary may not make such payments in an 
        amount exceeding 65 percent of the costs of such 
        services.
            (C) For the third or subsequent year of such 
        payments to a State, the Secretary may not make such 
        payments in an amount exceeding 55 percent of the costs 
        of such services.
            (2) The Secretary may not make a grant under 
        section 398(a) to a State unless the State agrees to 
        make available, directly or through donations from 
        public or private entities, non-Federal contributions 
        toward the costs of services to be provided pursuant to 
        such section in an amount equal to--
                    (A) for the first year of payments to the 
                State from the grant, not less than $25 (in 
                cash or in kind under subsection (c)) for each 
                $75 of Federal funds provided in the grant;
                    (B) for the second year of such payments to 
                the State, not less than $35 (in cash or in 
                kind under subsection (c)) for each $65 of such 
                Federal funds; and
                    (C) for the third or subsequent year of 
                such payments to the State, not less than $45 
                (in cash or in kind under subsection (c)) for 
                each $55 of such Federal funds.
    (b) Determination of Amount of Non-Federal Contribution.--
Non-Federal contributions required in subsection (b) may be in 
cash or in kind, fairly evaluated, including plant, equipment, 
or services. Amounts provided by the Federal Government, or 
services assisted or subsidized to any significant extent by 
the Federal Government, may not be included in determining the 
amount of such non-Federal contributions.

SEC. 398B. [280C-5] GENERAL PROVISIONS.

    (a) Limitation on Administrative Expenses.--The Secretary 
may not make a grant under section 398(a) to a State unless the 
State agrees that not more than 10 percent of the grant will be 
expended for administrative expenses with respect to the grant.
    (b) Description of Intended Use of Grant.--The Secretary 
may not make a grant under section 398(a) to a State unless--
            (1) the State submits to the Secretary a 
        description of the purposes for which the State intends 
        to expend the grant; and
            (2) such description provides information relating 
        to the programs and activities to be supported and 
        services to be provided, including--
                    (A) the number of individuals who will 
                receive services pursuant to section 398(a) and 
                the average costs of providing such services to 
                each such individual; and
                    (B) a description of the manner in which 
                such programs and activities will be 
                coordinated with any similar programs and 
                activities of public and private entities.
    (c) Requirement of Application.--The Secretary may not make 
a grant under section 398(a) to a State unless the State has 
submitted to the Secretary an application for the grant. The 
application shall--
            (1) contain the description of intended 
        expenditures required in subsection (b);
            (2) with respect to carrying out the purpose for 
        which the grant is to be made, provide assurances of 
        compliance satisfactory to the Secretary; and
            (3) otherwise be in such form, be made in such 
        manner, and contain such information and agreements as 
        the Secretary determines to be necessary to carry out 
        this subpart.
    (d) Evaluations and Report by Secretary.--The Secretary 
shall--
            (1) provide for an evaluation of each demonstration 
        project for which a grant is made under section 398(a); 
        and
            (2) not later than 6 months after the completion of 
        such evaluations, submit to the Congress a report 
        describing the findings made as a result of the 
        evaluations.
    (e) Authorizations of Appropriations.--For the purpose of 
carrying out this subpart, there are authorized to be 
appropriated $5,000,000 for each of the fiscal years 1988 
through 1990, $7,500,000 for fiscal year 1991, such sums as may 
be necessary for each of the fiscal years 1992 and 1993, 
$8,000,000 for fiscal year 1998, and such sums as may be 
necessary for each of the fiscal years 1999 through 2002.

  Subpart III--Grants for Home Visiting Services for At-Risk Families

SEC. 399. [280C-6] PROJECTS TO IMPROVE MATERNAL, INFANT, AND CHILD 
                    HEALTH.

    (a) In General.--
            (1) Establishment of program.--The Secretary, 
        acting through the Administrator of the Health 
        Resources and Services Administration, shall make 
        grants to eligible entities to pay the Federal share of 
        the cost of providing the services specified in 
        subsection (b) to families in which a member is--
                    (A) a pregnant woman at risk of delivering 
                an infant with a health or developmental 
                complication; or
                    (B) a child less than 3 years of age--
                            (i) who is experiencing or is at 
                        risk of a health or developmental 
                        complication, or of child abuse or 
                        neglect; or
                            (ii) who has been prenatally 
                        exposed to maternal substance abuse.
            (2) Minimum period of awards; administrative 
        consultations.--
                    (A) The Secretary shall award grants under 
                paragraph (1) for periods of at least three 
                years.
                    (B) The Administrator of the Administration 
                for Children, Youth, and Families and the 
                Director of the National Commission to Prevent 
                Infant Mortality shall be consulted regarding 
                the promulgation of program guidelines and 
                funding priorities under this section.
            (3) Requirement of status as medicaid provider.--
                    (A) Subject to subparagraph (B), the 
                Secretary may make a grant under paragraph (1) 
                only if, in the case of any service under such 
                paragraph that is covered in the State plan 
                approved under title XIX of the Social Security 
                Act for the State involved--
                            (i) the entity involved will 
                        provide the service directly, and the 
                        entity has entered into a participation 
                        agreement under the State plan and is 
                        qualified to receive payments under 
                        such plan; or
                            (ii) the entity will enter into an 
                        agreement with an organization under 
                        which the organization will provide the 
                        service, and the organization has 
                        entered into such a participation 
                        agreement and is qualified to receive 
                        such payments.
                    (B)(i) In the case of an organization 
                making an agreement under subparagraph (A)(ii) 
                regarding the provision of services under 
                paragraph (1), the requirement established in 
                such subparagraph regarding a participation 
                agreement shall be waived by the Secretary if 
                the organization does not, in providing health 
                or mental health services, impose a charge or 
                accept reimbursement available from any third-
                party payor, including reimbursement under any 
                insurance policy or under any Federal or State 
                health benefits program.
                    (ii) A determination by the Secretary of 
                whether an organization referred to in clause 
                (i) meets the criteria for a waiver under such 
                clause shall be made without regard to whether 
                the organization accepts voluntary donations 
                regarding the provision of services to the 
                public.
    (b) Home Visiting Services for Eligible Families.--With 
respect to an eligible family, each of the following services 
shall, directly or through arrangement with other public or 
nonprofit private entities, be available (as applicable to the 
family member involved) in each project operated with a grant 
under subsection (a):
            (1) Prenatal and postnatal health care.
            (2) Primary health care for the children, including 
        developmental assessments.
            (3) Education for the parents concerning infant 
        care and child development, including the development 
        and utilization of parent and teacher resource networks 
        and other family resource and support networks where 
        such networks are available.
            (4) Upon the request of a parent, providing the 
        education described in paragraph (3) to other 
        individuals who have responsibility for caring for the 
        children.
            (5) Education for the parents concerning behaviors 
        that adversely affect health.
            (6) Assistance in obtaining necessary health, 
        mental health, developmental, social, housing, and 
        nutrition services and other assistance, including 
        services and other assistance under maternal and child 
        health programs; the special supplemental nutrition 
        program for women, infants, and children; section 17 of 
        the Child Nutrition Act of 1966; title V of the Social 
        Security Act; title XIX of such Act (including the 
        program for early and periodic screening, diagnostic, 
        and treatment services described in section 1905(r) of 
        such Act); titles IV and XIX of the Social Security 
        Act; housing programs; other food assistance programs; 
        and appropriate alcohol and drug dependency treatment 
        programs, according to need.
    (c) Considerations in Making Grants.--In awarding grants 
under subsection (a), the Secretary shall take into 
consideration--
            (1) the ability of the entity involved to provide, 
        either directly or through linkages, a broad range of 
        preventive and primary health care services and related 
        social, family support, and developmental services;
            (2) different combinations of professional and lay 
        home visitors utilized within programs that are 
        reflective of the identified service needs and 
        characteristics of target populations;
            (3) the extent to which the population to be 
        targeted has limited access to health care, and related 
        social, family support, and developmental services; and
            (4) whether such grants are equitably distributed 
        among urban and rural settings and whether entities 
        serving Native American communities are represented 
        among the grantees.
    (d) Federal Share.--With respect to the costs of carrying 
out a project under subsection (a), a grant under such 
subsection for the project may not exceed 90 percent of such 
costs. To be eligible to receive such a grant, an applicant 
must provide assurances that the applicant will obtain at least 
10 percent of such costs from non-Federal funds (and such 
contributions to such costs may be in cash or in-kind, 
including facilities and personnel).
    (e) Rule of Construction Regarding At-Risk Births.--For 
purposes of subsection (a)(1), a pregnant woman shall be 
considered to be at risk of delivering an infant with a health 
or developmental complication if during the pregnancy the 
woman--
            (1) lacks appropriate access to, or information 
        concerning, early and routine prenatal care;
            (2) lacks the transportation necessary to gain 
        access to the services described in subsection (b);
            (3) lacks appropriate child care assistance, which 
        results in impeding the ability of such woman to 
        utilize health and related social services;
            (4) is fearful of accessing substance abuse 
        services or child and family support services; or
            (5) is a minor with a low income.
    (f) Delivery of Services and Case Management.--
            (1) Case management model.--Home visiting services 
        provided under this section shall be delivered 
        according to a case management model, and a registered 
        nurse, licensed social worker, or other licensed health 
        care professional with experience and expertise in 
        providing health and related social services in home 
        and community settings shall be assigned as the case 
        manager for individual cases under such model.
            (2) Case manager.--A case manager assigned under 
        paragraph (1) shall have primary responsibility for 
        coordinating and overseeing the development of a plan 
        for each family that is to receive home visiting 
        services under this section, and for coordinating the 
        delivery of such services provided through appropriate 
        personnel.
            (3) Appropriate personnel.--In determining which 
        personnel shall be utilized in the delivery of 
        services, the case manager shall consider--
                    (A) the stated objective of the project to 
                be operated with the grant, as determined after 
                considering identified gaps in the current 
                service delivery system; and
                    (B) the nature of the needs of the family 
                to be served, as determined at the initial 
                assessment of the family that is conducted by 
                the case manager, and through follow-up 
                contacts by other providers of home visiting 
                services.
            (4) Family service plan.--A case manager, in 
        consultation with a team established in accordance with 
        paragraph (5) for the family involved, shall develop a 
        plan for the family following the initial visit to the 
        home of the family. Such plan shall reflect--
                    (A) an assessment of the health and related 
                social service needs of the family;
                    (B) a structured plan for the delivery of 
                home visiting services to meet the identified 
                needs of the family;
                    (C) the frequency with which such services 
                are to be provided to the family;
                    (D) ongoing revisions made as the needs of 
                family members change; and
                    (E) the continuing voluntary participation 
                of the family in the plan.
            (5) Home visiting services team.--The team to be 
        consulted under paragraph (4) on behalf of a family 
        shall include, as appropriate, other nursing 
        professionals, physician assistants, social workers, 
        child welfare professionals, infant and early childhood 
        specialists, nutritionists, and laypersons trained as 
        home visitors. The case manager shall ensure that the 
        plan is coordinated with those physician services that 
        may be required by the mother or child.
    (g) Outreach.--Each grantee under subsection (a) shall 
provide outreach and casefinding services to inform eligible 
families of the availability of home visiting services from the 
project.
    (h) Confidentiality.--In accordance with applicable State 
law, an entity receiving a grant under subsection (a) shall 
maintain confidentiality with respect to services provided to 
families under this section.
    (i) Certain Assurances.--The Secretary may award a grant 
under subsection (a) only if the entity involved provides 
assurances satisfactory to the Secretary that--
            (1) the entity will provide home visiting services 
        with reasonable frequency--
                    (A) to families with pregnant women, as 
                early in the pregnancy as is practicable, and 
                until the infant reaches at least 2 years of 
                age; and
                    (B) to other eligible families, for at 
                least 2 years; and
            (2) the entity will coordinate with public health 
        and related social service agencies to prevent 
        duplication of effort and improve the delivery of 
        comprehensive health and related social services.
    (j) Submission to Secretary of Certain Information.--The 
Secretary may award a grant under subsection (a) only if the 
entity involved submits to the Secretary--
            (1) a description of the population to be targeted 
        for home visiting services and methods of outreach and 
        casefinding for identifying eligible families, 
        including the use of lay home visitors where 
        appropriate;
            (2) a description of the types and qualifications 
        of home visitors used by the entity and the process by 
        which the entity will provide continuing training and 
        sufficient support to the home visitors; and
            (3) such other information as the Secretary 
        determines to be appropriate.
    (k) Limitation Regarding Administrative Expenses.--Not more 
than 10 percent of a grant under subsection (a) may be expended 
for administrative expenses with respect to the grant. The 
costs of training individuals to serve in the project involved 
are not subject to the preceding sentence.
    (l) Restrictions on Use of Grant.--To be eligible to 
receive a grant under this section, an entity must agree that 
the grant will not be expended--
            (1) to provide inpatient hospital services;
            (2) to make cash payments to intended recipients of 
        services;
            (3) to purchase or improve land, purchase, 
        construct, or permanently improve (other than minor 
        remodeling) any building or other facility, or purchase 
        major medical equipment;
            (4) to satisfy any requirement for the expenditure 
        of non-Federal funds as a condition for the receipt of 
        Federal funds; or
            (5) to provide financial assistance to any entity 
        other than a public or nonprofit private entity.
    (m) Reports to Secretary.--To be eligible to receive a 
grant under this section, an entity must agree to submit an 
annual report on the services provided under this section to 
the Secretary in such manner and containing such information as 
the Secretary by regulation requires. At a minimum, the entity 
shall report information concerning eligible families, 
including--
            (1) the characteristics of the families and 
        children receiving services under this section;
            (2) the usage, nature, and location of the 
        provider, of preventive health services, including 
        prenatal, primary infant, and child health care;
            (3) the incidence of low birthweight and premature 
        infants;
            (4) the length of hospital stays for pre- and post-
        partum women and their children;
            (5) the incidence of substantiated child abuse and 
        neglect for all children within participating families;
            (6) the number of emergency room visits for routine 
        health care;
            (7) the source of payment for health care services 
        and the extent to which the utilization of health care 
        services, other than routine screening and medical 
        care, available to the individuals under the program 
        established under title XIX of the Social Security Act, 
        and under other Federal, State, and local programs, is 
        reduced;
            (8) the number and type of referrals made for 
        health and related social services, including alcohol 
        and drug treatment services, and the utilization of 
        such services provided by the grantee; and
            (9) the incidence of developmental disabilities.
    (n) Requirement of Application.--The Secretary may make a 
grant under subsection (a) only if--
            (1) an application for the grant is submitted to 
        the Secretary;
            (2) the application contains the agreements and 
        assurances required in this section, and the 
        information required in subsection (j);
            (3) the application contains evidence that the 
        preparation of the application has been coordinated 
        with the State agencies responsible for maternal and 
        child health and child welfare, and coordinated with 
        services provided under part C of the Individuals with 
        Disabilities Education Act; and
            (4) the application is in such form, is made in 
        such manner, and contains such agreements, assurances, 
        and information as the Secretary determines to be 
        necessary to carry out this section.
    (o) Peer Review.--
            (1) Requirement.--In making determinations for 
        awarding grants under subsection (a), the Secretary 
        shall rely on the recommendations of the peer review 
        panel established under paragraph (2).
            (2) Composition.--The Secretary shall establish a 
        review panel to make recommendations under paragraph 
        (1) that shall be composed of--
                    (A) national experts in the fields of 
                maternal and child health, child abuse and 
                neglect, and the provision of community-based 
                primary health services; and
                    (B) representatives of relevant Federal 
                agencies, including the Health Resources and 
                Services Administration, the Substance Abuse 
                and Mental Health Services Administration, the 
                Administration for Children, Youth, and 
                Families, the U.S. Advisory Board on Child 
                Abuse and Neglect, and the National Commission 
                to Prevent Infant Mortality.
    (p) Evaluations.--
            (1) In general.--The Secretary shall, directly or 
        through contracts with public or private entities--
                    (A) conduct evaluations to determine the 
                effectiveness of projects under subsection (a) 
                in reducing the incidence of children born with 
                health or developmental complications, the 
                incidence among children less than 3 years of 
                age of such complications, and the incidence of 
                child abuse and neglect; and
                    (B) not less than once during each 3-year 
                period, prepare and submit to the appropriate 
                committees of Congress a report concerning the 
                results of such evaluations.
            (2) Contents.--The evaluations conducted under 
        paragraph (1) shall--
                    (A) include a summary of the data contained 
                in the annual reports submitted under 
                subsection (m);
                    (B) assess the relative effectiveness of 
                projects under subsection (a) in urban and 
                rural areas, and among programs utilizing 
                differing combinations of professionals and 
                trained home visitors recruited from the 
                community to meet the needs of defined target 
                service populations; and
                    (C) make further recommendations necessary 
                or desirable to increase the effectiveness of 
                such projects.
    (q) Definitions.--For purposes of this section:
            (1) The term ``eligible entity'' includes public 
        and nonprofit private entities that provide health or 
        related social services, including community-based 
        organizations, visiting nurse organizations, hospitals, 
        local health departments, community health centers, 
        Native Hawaiian health centers, nurse managed clinics, 
        family service agencies, child welfare agencies, 
        developmental service providers, family resource and 
        support programs, and resource mothers projects.
            (2) The term ``eligible family'' means a family 
        described in subsection (a).
            (3) The term ``health or developmental 
        complication'', with respect to a child, means--
                    (A) being born in an unhealthy or 
                potentially unhealthy condition, including 
                premature birth, low birthweight, and prenatal 
                exposure to maternal substance abuse;
                    (B) a condition arising from a condition 
                described in subparagraph (A);
                    (C) a physical disability or delay; and
                    (D) a developmental disability or delay.
            (4) The term ``home visiting services'' means the 
        services specified in subsection (b), provided at the 
        residence of the eligible family involved or provided 
        pursuant to arrangements made for the family (including 
        arrangements for services in community settings).
            (5) The term ``home visitors'' means providers of 
        home visiting services.
    (r) Authorization of Appropriations.--For the purpose of 
carrying out this section, there is authorized to be 
appropriated $30,000,000 for each of the fiscal years 1993 and 
1994.

                             [Part L \1\--]
---------------------------------------------------------------------------

    \1\ The content of section 399A above, and the placement of the 
section in this Act, probably do not reflect the intent of the 
Congress. Section 399A formerly was section 399D. Section 3106 of 
Public Law 106-310 (114 Stat. 1175) attempts to make various amendments 
to section 399D, but the amendments cannot be executed because section 
399D was redesignated as section 399A by section 502(1) of such Public 
Law (114 Stat. 1115). (Section 399D now relates to technical assistance 
in operations of Statewide cancer registries.)
        Further, section 3106(m) of the Public Law (114 Stat. 1179) 
attempts to transfer section 399D to title V of this Act as a section 
519, but this transfer has not been executed because it applied to 
section 399D ``as amended by this section'' (section 3106), and no 
amendments described in section 3106 have been made to section 399D.
        As a conforming amendment, section 3106(n) of the Public Law 
provided that title III of this Act ``is amended by striking the 
heading for part L''. This amendment has been executed, but for the 
convenience of the reader, a designation for a part L is shown above in 
brackets to indicate the probable intent of the Congress that section 
399A is not included in part K of title III.
        For the convenience of the reader, an italicized note follows 
section 399A above showing the section as it would appear if the 
amendments described in section 3106 of the Public Law were executed to 
section 399A.
---------------------------------------------------------------------------

SEC. 399A. [280D] GRANTS FOR SERVICES FOR CHILDREN OF SUBSTANCE 
                    ABUSERS.\1\

    (a) Establishment.--
            (1) In general.--The Secretary, acting through the 
        Administrator of the Health Resources and Services 
        Administration, shall make grants to public and 
        nonprofit private entities for the purpose of carrying 
        out programs--
                    (A) to provide the services described in 
                subsection (b) to children of substance 
                abusers;
                    (B) to provide the applicable services 
                described in subsection (c) to families in 
                which a member is a substance abuser; and
                    (C) to identify such children and such 
                families.
            (2) Administrative consultations.--The 
        Administrator of the Administration for Children, 
        Youth, and Families and the Administrator of the 
        Substance Abuse and Mental Health Services 
        Administration shall be consulted regarding the 
        promulgation of program guidelines and funding 
        priorities under this section.
            (3) Requirement of status as medicaid provider.--
                    (A) Subject to subparagraph (B), the 
                Secretary may make a grant under paragraph (1) 
                only if, in the case of any service under such 
                paragraph that is covered in the State plan 
                approved under title XIX of the Social Security 
                Act for the State involved--
                            (i) the entity involved will 
                        provide the service directly, and the 
                        entity has entered into a participation 
                        agreement under the State plan and is 
                        qualified to receive payments under 
                        such plan; or
                            (ii) the entity will enter into an 
                        agreement with an organization under 
                        which the organization will provide the 
                        service, and the organization has 
                        entered into such a participation 
                        agreement and is qualified to receive 
                        such payments.
                    (B)(i) In the case of an organization 
                making an agreement under subparagraph (A)(ii) 
                regarding the provision of services under 
                paragraph (1), the requirement established in 
                such subparagraph regarding a participation 
                agreement shall be waived by the Secretary if 
                the organization does not, in providing health 
                or mental health services, impose a charge or 
                accept reimbursement available from any third-
                party payor, including reimbursement under any 
                insurance policy or under any Federal or State 
                health benefits program.
                    (ii) A determination by the Secretary of 
                whether an organization referred to in clause 
                (i) meets the criteria for a waiver under such 
                clause shall be made without regard to whether 
                the organization accepts voluntary donations 
                regarding the provision of services to the 
                public.
    (b) Services for Children of Substance Abusers.--The 
Secretary may make a grant under subsection (a) only if the 
applicant involved agrees to make available (directly or 
through agreements with other entities) to children of 
substance abusers each of the following services:
            (1) Periodic evaluation of children for 
        developmental, psychological, and medical problems.
            (2) Primary pediatric care.
            (3) Other necessary health and mental health 
        services.
            (4) Therapeutic intervention services for children, 
        including provision of therapeutic child care.
            (5) Preventive counseling services.
            (6) Counseling related to the witnessing of chronic 
        violence.
            (7) Referrals for, and assistance in establishing 
        eligibility for, services provided under--
                    (A) education and special education 
                programs;
                    (B) Head Start programs established under 
                the Head Start Act;
                    (C) other early childhood programs;
                    (D) employment and training programs;
                    (E) public assistance programs provided by 
                Federal, State, or local governments; and
                    (F) programs offered by vocational 
                rehabilitation agencies, recreation 
                departments, and housing agencies.
            (8) Additional developmental services that are 
        consistent with the provision of early intervention 
        services, as such term is defined in part C of the 
        Individuals with Disabilities Education Act.
    (c) Services for Affected Families.--The Secretary may make 
a grant under subsection (a) only if, in the case of families 
in which a member is a substance abuser, the applicant involved 
agrees to make available (directly or through agreements with 
other entities) each of the following services, as applicable 
to the family member involved:
            (1) Services as follows, to be provided by a public 
        health nurse, social worker, or similar professional, 
        or by a trained worker from the community who is 
        supervised by a professional:
                    (A) Counseling to substance abusers on the 
                benefits and availability of substance abuse 
                treatment services and services for children of 
                substance abusers.
                    (B) Assistance to substance abusers in 
                obtaining and using substance abuse treatment 
                services and in obtaining the services 
                described in subsection (b) for their children.
                    (C) Visiting and providing support to 
                substance abusers, especially pregnant women, 
                who are receiving substance abuse treatment 
                services or whose children are receiving 
                services under subsection (b).
            (2) In the case of substance abusers:
                    (A) Encouragement and, where necessary, 
                referrals to participate in appropriate 
                substance abuse treatment.
                    (B) Primary health care and mental health 
                services, including prenatal and post partum 
                care for pregnant women.
                    (C) Consultation and referral regarding 
                subsequent pregnancies and life options, 
                including education and career planning.
                    (D) Where appropriate, counseling regarding 
                family conflict and violence.
                    (E) Remedial education services.
                    (F) Referrals for, and assistance in 
                establishing eligibility for, services 
                described in subsection (b)(7).
            (3) In the case of substance abusers, spouses of 
        substance abusers, extended family members of substance 
        abusers, caretakers of children of substance abusers, 
        and other people significantly involved in the lives of 
        substance abusers or the children of substance abusers:
                    (A) An assessment of the strengths and 
                service needs of the family and the assignment 
                of a case manager who will coordinate services 
                for the family.
                    (B) Therapeutic intervention services, such 
                as parental counseling, joint counseling 
                sessions for families and children, and family 
                therapy.
                    (C) Child care or other care for the child 
                to enable the parent to attend treatment or 
                other activities and respite care services.
                    (D) Parenting education services and parent 
                support groups.
                    (E) Support services, including, where 
                appropriate, transportation services.
                    (F) Where appropriate, referral of other 
                family members to related services such as job 
                training.
                    (G) Aftercare services, including continued 
                support through parent groups and home visits.
    (d) Considerations in Making Grants.--In making grants 
under subsection (a), the Secretary shall ensure that the 
grants are reasonably distributed among the following types of 
entities:
            (1) Alcohol and drug treatment programs, especially 
        those providing treatment to pregnant women and mothers 
        and their children.
            (2) Public or nonprofit private entities that 
        provide health or social services to disadvantaged 
        populations, and that have--
                    (A) expertise in applying the services to 
                the particular problems of substance abusers 
                and the children of substance abusers; and
                    (B) an affiliation or contractual 
                relationship with one or more substance abuse 
                treatment programs.
            (3) Consortia of public or nonprofit private 
        entities that include at least one substance abuse 
        treatment program.
            (4) Indian tribes.
    (e) Federal Share.--The Federal share of a program carried 
out under subsection (a) shall be 90 percent. The Secretary 
shall accept the value of in-kind contributions, including 
facilities and personnel, made by the grant recipient as a part 
or all of the non-Federal share of grants.
    (f) Coordination With Other Providers.--The Secretary may 
make a grant under subsection (a) only if the applicant 
involved agrees to coordinate its activities with those of the 
State lead agency, and the State Interagency Coordinating 
Council, under part C of the Individuals with Disabilities 
Education Act.
    (g) Restrictions on Use of Grant.--The Secretary may make a 
grant under subsection (a) only if the applicant involved 
agrees that the grant will not be expended--
            (1) to provide inpatient hospital services;
            (2) to make cash payments to intended recipients of 
        services;
            (3) to purchase or improve land, purchase, 
        construct, or permanently improve (other than minor 
        remodeling) any building or other facility, or purchase 
        major medical equipment;
            (4) to satisfy any requirement for the expenditure 
        of non-Federal funds as a condition for the receipt of 
        Federal funds; or
            (5) to provide financial assistance to any entity 
        other than a public or nonprofit private entity.
    (h) Submission to Secretary of Certain Information.--The 
Secretary may make a grant under subsection (a) only if the 
applicant involved submits to the Secretary--
            (1) a description of the population that is to 
        receive services under this section and a description 
        of such services that are to be provided and measurable 
        goals and objectives;
            (2) a description of the mechanism that will be 
        used to involve the local public agencies responsible 
        for health, mental health, child welfare, education, 
        juvenile justice, developmental disabilities, and 
        substance abuse treatment programs in planning and 
        providing services under this section, as well as 
        evidence that the proposal has been coordinated with 
        the State agencies responsible for administering those 
        programs and the State agency responsible for 
        administering public maternal and child health 
        services;
            (3) information demonstrating that the applicant 
        has established a collaborative relationship with child 
        welfare agencies and child protective services that 
        will enable the applicant, where appropriate, to--
                    (A) provide advocacy on behalf of substance 
                abusers and the children of substance abusers 
                in child protective services cases;
                    (B) provide services to help prevent the 
                unnecessary placement of children in substitute 
                care; and
                    (C) promote reunification of families or 
                permanent plans for the placement of the child; 
                and
            (4) such other information as the Secretary 
        determines to be appropriate.
    (i) Reports to Secretary.--The Secretary may make a grant 
under subsection (a) only if the applicant involved agrees that 
for each fiscal year for which the applicant receives such a 
grant the applicant, in accordance with uniform standards 
developed by the Secretary, will submit to the Secretary a 
report containing--
            (1) a description of specific services and 
        activities provided under the grant;
            (2) information regarding progress toward meeting 
        the program's stated goals and objectives;
            (3) information concerning the extent of use of 
        services provided under the grant, including the number 
        of referrals to related services and information on 
        other programs or services accessed by children, 
        parents, and other caretakers;
            (4) information concerning the extent to which 
        parents were able to access and receive treatment for 
        alcohol and drug abuse and sustain participation in 
        treatment over time until the provider and the 
        individual receiving treatment agree to end such 
        treatment, and the extent to which parents re-enter 
        treatment after the successful or unsuccessful 
        termination of treatment;
            (5) information concerning the costs of the 
        services provided and the source of financing for 
        health care services;
            (6) information concerning--
                    (A) the number and characteristics of 
                families, parents, and children served, 
                including a description of the type and 
                severity of childhood disabilities, and an 
                analysis of the number of children served by 
                age;
                    (B) the number of children served who 
                remained with their parents during the period 
                in which entities provided services under this 
                section;
                    (C) the number of children served who were 
                placed in out-of-home care during the period in 
                which entities provided services under this 
                section;
                    (D) the number of children described in 
                subparagraph (C) who were reunited with their 
                families; and
                    (E) the number of children described in 
                subparagraph (C) for whom a permanent plan has 
                not been made or for whom the permanent plan is 
                other than family reunification;
            (7) information on hospitalization or emergency 
        room use by the family members participating in the 
        program; and
            (8) such other information as the Secretary 
        determines to be appropriate.
    (j) Requirement of Application.--The Secretary may make any 
grant under subsection (a) only if--
            (1) an application for the grant is submitted to 
        the Secretary;
            (2) the application contains the agreements 
        required in this section and the information required 
        in subsection (h); and
            (3) the application is in such form, is made in 
        such manner, and contains such agreements, assurances, 
        and information as the Secretary determines to be 
        necessary to carry out this section.
    (k) Peer Review.--
            (1) Requirement.--In making determinations for 
        awarding grants under subsection (a), the Secretary 
        shall rely on the recommendations of the peer review 
        panel established under paragraph (2).
            (2) Composition.--The Secretary shall establish a 
        review panel to make recommendations under paragraph 
        (1) that shall be composed of--
                    (A) national experts in the fields of 
                maternal and child health, substance abuse 
                treatment, and child welfare; and
                    (B) representatives of relevant Federal 
                agencies, including the Health Resources and 
                Services Administration, the Substance Abuse 
                and Mental Health Services Administration, and 
                the Administration for Children, Youth, and 
                Families.
    (l) Evaluations.--The Secretary shall periodically conduct 
evaluations to determine the effectiveness of programs 
supported under subsection (a)--
            (1) in reducing the incidence of alcohol and drug 
        abuse among substance abusers participating in the 
        programs;
            (2) in preventing adverse health conditions in 
        children of substance abusers;
            (3) in promoting better utilization of health and 
        developmental services and improving the health, 
        developmental, and psychological status of children 
        receiving services under the program;
            (4) in improving parental and family functioning;
            (5) in reducing the incidence of out-of-home 
        placement for children whose parents receive services 
        under the program; and
            (6) in facilitating the reunification of families 
        after children have been placed in out-of-home care.
    (m) Report to Congress.--Not later than 2 years after the 
date on which amounts are first appropriated under subjection 
(o), the Secretary shall prepare and submit to the Committee on 
Energy and Commerce of the House of Representatives, and to the 
Committee on Labor and Human Resources of the Senate, a report 
that contains a description of programs carried out under this 
section. At a minimum, the report shall contain--
            (1) information concerning the number and type of 
        programs receiving grants;
            (2) information concerning the type and use of 
        services offered;
            (3) information concerning--
                    (A) the number and characteristics of 
                families, parents, and children served;
                    (B) the number of children served who 
                remained with their parents during or after the 
                period in which entities provided services 
                under this section;
                    (C) the number of children served who were 
                placed in out-of-home care during the period in 
                which entities provided services under this 
                section;
                    (D) the number of children described in 
                subparagraph (C) who were reunited with their 
                families; and
                    (E) the number of children described in 
                subparagraph (C) who were permanently placed in 
                out-of-home care;
        analyzed by the type of entity described in subsection 
        (d) that provided services;
            (4) an analysis of the access provided to, and use 
        of, related services and alcohol and drug treatment 
        through programs carried out under this section; and
            (5) a comparison of the costs of providing services 
        through each of the types of entities described in 
        subsection (d).
    (n)  Data Collection.--The Secretary shall periodically 
collect and report on information concerning the numbers of 
children in substance abusing families, including information 
on the age, gender and ethnicity of the children, the 
composition and income of the family, and the source of health 
care finances.
    (o) Definitions.--For purposes of this section:
            (1) The term ``caretaker'', with respect to a child 
        of a substance abuser, means any individual acting in a 
        parental role regarding the child (including any birth 
        parent, foster parent, adoptive parent, relative of 
        such a child, or other individual acting in such a 
        role).
            (2) The term ``children of substance abusers'' 
        means--
                    (A) children who have lived or are living 
                in a household with a substance abuser who is 
                acting in a parental role regarding the 
                children; and
                    (B) children who have been prenatally 
                exposed to alcohol or other dangerous drugs.
            (3) The term ``Indian tribe'' means any tribe, 
        band, nation, or other organized group or community of 
        Indians, including any Alaska Native village (as 
        defined in, or established pursuant to, the Alaska 
        Native Claims Settlement Act), that is recognized as 
        eligible for the special programs and services provided 
        by the United States to Indians because of their status 
        as Indians.
            (4) The term ``public or nonprofit private entities 
        that provide health or social services to disadvantaged 
        populations'' includes community-based organizations, 
        local public health departments, community action 
        agencies, hospitals, community health centers, child 
        welfare agencies, developmental disabilities service 
        providers, and family resource and support programs.
            (5) The term ``substance abuse'' means the abuse of 
        alcohol or other drugs.
    (p) Funding.--
            (1) Authorization of appropriations.--For the 
        purpose of carrying out this section, there are 
        authorized to be appropriated $50,000,000 for fiscal 
        year 1993, and such sums as may be necessary for fiscal 
        year 1994.
            (2) Contingent authority regarding training of 
        certain individuals.--Of the amounts appropriated under 
        paragraph (1) for a fiscal year in excess of 
        $25,000,000, the Secretary may make available not more 
        than 15 percent for the training of health care 
        professionals and other personnel (including child 
        welfare providers) who provide services to children and 
        families of substance abusers.

======================================================================


    NOTE: For the convenience of the reader, the following 
indicates the probable intent of the Congress by showing 
section 399A as the section would appear if the amendments 
described in section 3106 of Public Law 106-310 (114 Stat. 
1175) were executed to section 399A, rather than to section 
399D as instructed by such section 3106, including the 
amendment that redesignates the section as section 519 (toward 
the purpose of transferring the section to title V of this 
Act). See footnote on page 619.

SEC. 519. [280D] GRANTS FOR SERVICES FOR CHILDREN OF SUBSTANCE ABUSERS.

    (a) Establishment.--
            (1) In general.--The Secretary, acting through the 
        Administrator of the Substance Abuse and Mental Health 
        Services Administration, shall make grants to public 
        and nonprofit private entities for the purpose of 
        carrying out programs--
                    (A) to provide the services described in 
                subsection (b) to children of substance 
                abusers;
                    (B) to provide the applicable services 
                described in subsection (c) to families in 
                which a member is a substance abuser;
                    (C) to identify such children and such 
                families through youth service agencies, family 
                social services, child care providers, Head 
                Start, schools and after-school programs, early 
                childhood development programs, community-based 
                family resource and support centers, the 
                criminal justice system, health, substance 
                abuse and mental health providers through 
                screenings conducted during regular childhood 
                examinations and other examinations, self and 
                family member referrals, substance abuse 
                treatment services, and other providers of 
                services to children and families; and
                    (D) to provide education and training to 
                health, substance abuse and mental health 
                professionals, and other providers of services 
                to children and families through youth service 
                agencies, family social services, child care, 
                Head Start, schools and after-school programs, 
                early childhood development programs, 
                community-based family resource and support 
                centers, the criminal justice system, and other 
                providers of services to children and families.
            (2) Administrative consultations.--The 
        Administrator of the Administration for Children, 
        Youth, and Families and the Administrator of the Health 
        Resources and Services Administration shall be 
        consulted regarding the promulgation of program 
        guidelines and funding priorities under this section.
            (3) Requirement of status as medicaid provider.--
                    (A) Subject to subparagraph (B), the 
                Secretary may make a grant under paragraph (1) 
                only if, in the case of any service under such 
                paragraph that is covered in the State plan 
                approved under title XIX of the Social Security 
                Act for the State involved--
                            (i)(I) the entity involved will 
                        provide the service directly, and the 
                        entity has entered into a participation 
                        agreement under the State plan and is 
                        qualified to receive payments under 
                        such plan; or
                            (II) the entity will enter into an 
                        agreement with an organization under 
                        which the organization will provide the 
                        service, and the organization has 
                        entered into such a participation 
                        agreement and is qualified to receive 
                        such payments; and
                            (ii) the entity will identify 
                        children who may be eligible for 
                        medical assistance under a State 
                        program under title XIX or XXI of the 
                        Social Security Act.
                    (B)(i) In the case of an organization 
                making an agreement under subparagraph (A)(ii) 
                regarding the provision of services under 
                paragraph (1), the requirement established in 
                such subparagraph regarding a participation 
                agreement shall be waived by the Secretary if 
                the organization does not, in providing health 
                or mental health services, impose a charge or 
                accept reimbursement available from any third-
                party payor, including reimbursement under any 
                insurance policy or under any Federal or State 
                health benefits program.
                    (ii) A determination by the Secretary of 
                whether an organization referred to in clause 
                (i) meets the criteria for a waiver under such 
                clause shall be made without regard to whether 
                the organization accepts voluntary donations 
                regarding the provision of services to the 
                public.
    (b) Services for Children of Substance Abusers.--The 
Secretary may make a grant under subsection (a) only if the 
applicant involved agrees to make available (directly or 
through agreements with other entities) to children of 
substance abusers each of the following services:
            (1) Periodic evaluation of children for 
        developmental, psychological, alcohol and drug, and 
        medical problems.
            (2) Primary pediatric care.
            (3) Other necessary health and mental health 
        services.
            (4) Therapeutic intervention services for children, 
        including provision of therapeutic child care.
            (5) Developmentally and age-appropriate drug and 
        alcohol early intervention, treatment and prevention 
        services.
            (6) Counseling related to the witnessing of chronic 
        violence.
            (7) Referrals for, and assistance in establishing 
        eligibility for, services provided under--
                    (A) education and special education 
                programs;
                    (B) Head Start programs established under 
                the Head Start Act;
                    (C) other early childhood programs;
                    (D) employment and training programs;
                    (E) public assistance programs provided by 
                Federal, State, or local governments; and
                    (F) programs offered by vocational 
                rehabilitation agencies, recreation 
                departments, and housing agencies.
            (8) Additional developmental services that are 
        consistent with the provision of early intervention 
        services, as such term is defined in part H of the 
        Individuals with Disabilities Education Act.
Services shall be provided under paragraphs (2) through (8) by 
a public health nurse, social worker, or similar professional, 
or by a trained worker from the community who is supervised by 
a professional, or by an entity, where the professional or 
entity provides assurances that the professional or entity is 
licensed or certified by the State if required and is complying 
with applicable licensure or certification requirements.
    (c) Services for Affected Families.--The Secretary may make 
a grant under subsection (a) only if, in the case of families 
in which a member is a substance abuser, the applicant involved 
agrees to make available (directly or through agreements with 
other entities) each of the following services, as applicable 
to the family member involved:
            (1) Services as follows, to be provided by a public 
        health nurse, social worker, or similar professional, 
        or by a trained worker from the community who is 
        supervised by a professional, or by an entity, where 
        the professional or entity provides assurances that the 
        professional or entity is licensed or certified by the 
        State if required and is complying with applicable 
        licensure or certification requirements:
                    (A) Counseling to substance abusers on the 
                benefits and availability of substance abuse 
                treatment services and services for children of 
                substance abusers.
                    (B) Assistance to substance abusers in 
                obtaining and using substance abuse treatment 
                services and in obtaining the services 
                described in subsection (b) for their children.
                    (C) Visiting and providing support to 
                substance abusers, especially pregnant women, 
                who are receiving substance abuse treatment 
                services or whose children are receiving 
                services under subsection (b).
                    (D) Aggressive outreach to family members 
                with substance abuse problems.
                    (E) Inclusion of consumer in the 
                development, implementation, and monitoring of 
                Family Services Plan.
            (2) In the case of substance abusers:
                    (A) Alcohol and drug treatment services, 
                including screening and assessment, diagnosis, 
                detoxification, individual, group and family 
                counseling, relapse prevention, pharmacotherapy 
                treatment, after-care services, and case 
                management.
                    (B) Primary health care and mental health 
                services, including prenatal and post partum 
                care for pregnant women.
                    (C) Consultation and referral regarding 
                subsequent pregnancies and life options and 
                counseling on the human immunodeficiency virus 
                and acquired immune deficiency syndrome.
                    (D) Where appropriate, counseling regarding 
                family violence.
                    (E) Career planning and education services.
                    (F) Referrals for, and assistance in 
                establishing eligibility for, services 
                described in subsection (b)(7).
            (3) In the case of substance abusers, spouses of 
        substance abusers, extended family members of substance 
        abusers, caretakers of children of substance abusers, 
        and other people significantly involved in the lives of 
        substance abusers or the children of substance abusers:
                    (A) An assessment of the strengths and 
                service needs of the family and the assignment 
                of a case manager who will coordinate services 
                for the family.
                    (B) Therapeutic intervention services, such 
                as parental counseling, joint counseling 
                sessions for families and children, and family 
                therapy.
                    (C) Child care or other care for the child 
                to enable the parent to attend treatment or 
                other activities and respite care services.
                    (D) Parenting education services and parent 
                support groups which include child abuse and 
                neglect prevention techniques.
                    (E) Support services, including, where 
                appropriate, transportation services.
                    (F) Where appropriate, referral of other 
                family members to related services such as job 
                training.
                    (G) Aftercare services, including continued 
                support through parent groups and home visits.
    (d) Training for Providers of Services to Children and 
Families.--The Secretary may make a grant under subsection (a) 
for the training of health, substance abuse and mental health 
professionals and other providers of services to children and 
families through youth service agencies, family social 
services, child care providers, Head Start, schools and after-
school programs, early childhood development programs, 
community-based family resource centers, the criminal justice 
system, and other providers of services to children and 
families. Such training shall be to assist professionals in 
recognizing the drug and alcohol problems of their clients and 
to enhance their skills in identifying and understanding the 
nature of substance abuse, and obtaining substance abuse early 
intervention, prevention and treatment resources.
    (e) Eligible Entities.--The Secretary shall distribute the 
grants through the following types of entities:
            (1) Alcohol and drug early intervention, prevention 
        or treatment programs, especially those providing 
        treatment to pregnant women and mothers and their 
        children.
            (2) Public or nonprofit private entities that 
        provide health or social services to disadvantaged 
        populations, and that have--
                    (A) expertise in applying the services to 
                the particular problems of substance abusers 
                and the children of substance abusers; or
                    (B) an affiliation or contractual 
                relationship with one or more substance abuse 
                treatment programs or pediatric health or 
                mental health providers and family mental 
                health providers.
            (3) Consortia of public or nonprofit private 
        entities that include at least one substance abuse 
        treatment program.
            (4) Indian tribes.
    (f) Federal Share.--The Federal share of a program carried 
out under subsection (a) shall be 90 percent. The Secretary 
shall accept the value of in-kind contributions, including 
facilities and personnel, made by the grant recipient as a part 
or all of the non-Federal share of grants.
    (g) Restrictions on Use of Grant.--The Secretary may make a 
grant under subsection (a) only if the applicant involved 
agrees that the grant will not be expended--
            (1) to provide inpatient hospital services;
            (2) to make cash payments to intended recipients of 
        services;
            (3) to purchase or improve land, purchase, 
        construct, or permanently improve (other than minor 
        remodeling) any building or other facility, or purchase 
        major medical equipment;
            (4) to satisfy any requirement for the expenditure 
        of non-Federal funds as a condition for the receipt of 
        Federal funds; or
            (5) to provide financial assistance to any entity 
        other than a public or nonprofit private entity.
    (h) Submission to Secretary of Certain Information.--The 
Secretary may make a grant under subsection (a) only if the 
applicant involved submits to the Secretary--
            (1) a description of the population that is to 
        receive services under this section and a description 
        of such services that are to be provided and measurable 
        goals and objectives;
            (2) a description of the mechanism that will be 
        used to involve the local public agencies responsible 
        for health, including maternal and child health \1\ 
        mental health, child welfare, education, juvenile 
        justice, developmental disabilities, and substance 
        abuse in planning and providing services under this 
        section, as well as evidence that the proposal has been 
        coordinated with the State agencies responsible for 
        administering those programs, the State agency 
        responsible for administering alcohol and drug 
        programs, the State lead agency, and the State 
        Interagency Coordinating Council under part H of the 
        Individuals with Disabilities Education Act; and; \2\
---------------------------------------------------------------------------
    \1\ The lack of a comma would be so in law. See section 
3106(e)(1)(A) of Public Law 106-310 (114 Stat. 1177).
    \2\ The superfluous semicolon would be so in law. See section 
3106(e)(1)(C) of Public Law 106-310 (114 Stat. 1177).
---------------------------------------------------------------------------
            (3) such other information as the Secretary 
        determines to be appropriate.
    (i) Reports to Secretary.--The Secretary may make a grant 
under subsection (a) only if the applicant involved agrees that 
for each fiscal year for which the applicant receives such a 
grant the applicant, in accordance with uniform standards 
developed by the Secretary, will submit to the Secretary a 
report containing--
            (1) a description of specific services and 
        activities provided under the grant;
            (2) information regarding progress toward meeting 
        the program's stated goals and objectives;
            (3) information concerning the extent of use of 
        services provided under the grant, including the number 
        of referrals to related services and information on 
        other programs or services accessed by children, 
        parents, and other caretakers;
            (4) information concerning the extent to which 
        parents were able to access and receive treatment for 
        alcohol and drug abuse and sustain participation in 
        treatment over time until the provider and the 
        individual receiving treatment agree to end such 
        treatment, and the extent to which parents re-enter 
        treatment after the successful or unsuccessful 
        termination of treatment;
            (5) information concerning the costs of the 
        services provided and the source of financing for 
        health care services;
            (6) information concerning--
                    (A) the number and characteristics of 
                families, parents, and children served, 
                including a description of the type and 
                severity of childhood disabilities, and an 
                analysis of the number of children served by 
                age;
                    (B) the number of children served who 
                remained with their parents during the period 
                in which entities provided services under this 
                section; and
                    (C) the number of case workers or other 
                professionals trained to identify and address 
                substance abuse issues.
            (7) information on hospitalization or emergency 
        room use by the family members participating in the 
        program; and
            (8) such other information as the Secretary 
        determines to be appropriate.
    (j) Requirement of Application.--The Secretary may make any 
grant under subsection (a) only if--
            (1) an application for the grant is submitted to 
        the Secretary;
            (2) the application contains the agreements 
        required in this section and the information required 
        in subsection (h); and
            (3) the application is in such form, is made in 
        such manner, and contains such agreements, assurances, 
        and information as the Secretary determines to be 
        necessary to carry out this section.
    (k) Evaluations.--The Secretary shall periodically conduct 
evaluations to determine the effectiveness of programs 
supported under subsection (a)--
            (1) in reducing the incidence of alcohol and drug 
        abuse among substance abusers participating in the 
        programs;
            (2) in preventing adverse health conditions in 
        children of substance abusers;
            (3) in promoting better utilization of health and 
        developmental services and improving the health, 
        developmental, and psychological status of children 
        receiving services under the program; and
            (4) in improving parental and family functioning, 
        including increased participation in work or 
        employment-related activities and decreased 
        participation in welfare programs.
    (l) Report to Congress.--Not later than 2 years after the 
date on which amounts are first appropriated under subjection 
(o), the Secretary shall prepare and submit to the Committee on 
Energy and Commerce of the House of Representatives, and to the 
Committee on Labor and Human Resources of the Senate, a report 
that contains a description of programs carried out under this 
section. At a minimum, the report shall contain--
            (1) information concerning the number and type of 
        programs receiving grants;
            (2) information concerning the type and use of 
        services offered; and
            (3) information concerning--
                    (A) the number and characteristics of 
                families, parents, and children served; and
                    (B) the number of children served who 
                remained with their parents during or after the 
                period in which entities provided services 
                under this section. \1\
---------------------------------------------------------------------------
    \1\ The period at the end of subparagraph (B), and the semicolon at 
the end of paragraph (3), would be so in law. See section 3106(h) of 
Public Law 106-310 (114 Stat. 1178). The period probably should be a 
semicolon, and the semicolon probably should be a period.
---------------------------------------------------------------------------
        analyzed by the type of entity described in subsection 
        (d) \2\ that provided services; \3\
---------------------------------------------------------------------------
    \2\ The reference to subsection (d) probably should be a reference 
to subsection (e). Section 3106(l) of Public Law 106-310 (114 Stat. 
1178) would redesignate subsection (d) as subsection (e) and make 
conforming changes in cross-references. One of the conforming changes 
would be to subsection (m), and would strike ``(d)'' and insert 
``(e)''. The reference to subsection (d) appears in subsection (l), 
however, not subsection (m).
    \3\ See footnote for subsection (l)(3)(B).
---------------------------------------------------------------------------
    (m)  Data Collection.--The Secretary shall periodically 
collect and report on information concerning the numbers of 
children in substance abusing families, including information 
on the age, gender and ethnicity of the children, the 
composition and income of the family, and the source of health 
care finances. The periodic report shall include a quantitative 
estimate of the prevalence of alcohol and drug problems in 
families involved in the child welfare system, the barriers to 
treatment and prevention services facing these families, and 
policy recommendations for removing the identified barriers, 
including training for child welfare workers.
    (n) Definitions.--For purposes of this section:
            (1) The term ``caretaker'', with respect to a child 
        of a substance abuser, means any individual acting in a 
        parental role regarding the child (including any birth 
        parent, foster parent, adoptive parent, relative of 
        such a child, or other individual acting in such a 
        role).
            (2) The term ``children of substance abusers'' 
        means--
                    (A) children who have lived or are living 
                in a household with a substance abuser who is 
                acting in a parental role regarding the 
                children; and
                    (B) children who have been prenatally 
                exposed to alcohol or other drugs.
            (3) The term ``Indian tribe'' means any tribe, 
        band, nation, or other organized group or community of 
        Indians, including any Alaska Native village (as 
        defined in, or established pursuant to, the Alaska 
        Native Claims Settlement Act), that is recognized as 
        eligible for the special programs and services provided 
        by the United States to Indians because of their status 
        as Indians.
            (4) The term ``public or nonprofit private entities 
        that provide health or social services to disadvantaged 
        populations'' includes community-based organizations, 
        local public health departments, community action 
        agencies, hospitals, community health centers, child 
        welfare agencies, developmental disabilities service 
        providers, and family resource and support programs.
            (5) The term ``substance abuse'' means the abuse of 
        alcohol or other drugs.
    (o) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated $50,000,000 for fiscal year 2001, and such sums as 
may be necessary for each of fiscal years 2002 and 2003.
=======================================================================


             Part M--National Program of Cancer Registries

SEC. 399B. [280E] NATIONAL PROGRAM OF CANCER REGISTRIES.

    (a) In General.--
            (1) Statewide cancer registries.--The Secretary, 
        acting through the Director of the Centers for Disease 
        Control, may make grants to States, or may make grants 
        or enter into contracts with academic or nonprofit 
        organizations designated by the State to operate the 
        State's cancer registry in lieu of making a grant 
        directly to the State, to support the operation of 
        population-based, statewide registries to collect, for 
        each condition specified in paragraph (2)(A), data 
        concerning--
                    (A) demographic information about each case 
                of cancer;
                    (B) information on the industrial or 
                occupational history of the individuals with 
                the cancers, to the extent such information is 
                available from the same record;
                    (C) administrative information, including 
                date of diagnosis and source of information;
                    (D) pathological data characterizing the 
                cancer, including the cancer site, stage of 
                disease (pursuant to Staging Guide), incidence, 
                and type of treatment; and
                    (E) other elements determined appropriate 
                by the Secretary.
            (2) Cancer; benign brain-related tumors.--
                    (A) In general.--For purposes of paragraph 
                (1), the conditions referred to in this 
                paragraph are the following:
                            (i) Each form of in-situ and 
                        invasive cancer (with the exception of 
                        basal cell and squamous cell carcinoma 
                        of the skin), including malignant 
                        brain-related tumors.
                            (ii) Benign brain-related tumors.
                    (B) Brain-related tumor.--For purposes of 
                subparagraph (A):
                            (i) The term ``brain-related 
                        tumor'' means a listed primary tumor 
                        (whether malignant or benign) occurring 
                        in any of the following sites:
                                    (I) The brain, meninges, 
                                spinal cord, cauda equina, a 
                                cranial nerve or nerves, or any 
                                other part of the central 
                                nervous system.
                                    (II) The pituitary gland, 
                                pineal gland, or 
                                craniopharyngeal duct.
                            (ii) The term ``listed'', with 
                        respect to a primary tumor, means a 
                        primary tumor that is listed in the 
                        International Classification of 
                        Diseases for Oncology (commonly 
                        referred to as the ICD-O).
                            (iii) The term ``International 
                        Classification of Diseases for 
                        Oncology'' means a classification 
                        system that includes topography (site) 
                        information and histology (cell type 
                        information) developed by the World 
                        Health Organization, in collaboration 
                        with international centers, to promote 
                        international comparability in the 
                        collection, classification, processing, 
                        and presentation of cancer statistics. 
                        The ICD-O system is a supplement to the 
                        International Statistical 
                        Classification of Diseases and Related 
                        Health Problems (commonly known as the 
                        ICD) and is the standard coding system 
                        used by cancer registries worldwide. 
                        Such term includes any modification 
                        made to such system for purposes of the 
                        United States. Such term further 
                        includes any published classification 
                        system that is internationally 
                        recognized as a successor to the 
                        classification system referred to in 
                        the first sentence of this clause.
                    (C) Statewide cancer registry.--References 
                in this section to cancer registries shall be 
                considered to be references to registries 
                described in this subsection.
    (b) Matching Funds.--
            (1) In general.--The Secretary may make a grant 
        under subsection (a) only if the State, or the academic 
        or nonprofit private organization designated by the 
        State to operate the cancer registry of the State, 
        involved agrees, with respect to the costs of the 
        program, to make available (directly or through 
        donations from public or private entities) non-Federal 
        contributions toward such costs in an amount that is 
        not less than 25 percent of such costs or $1 for every 
        $3 of Federal funds provided in the grant.
            (2) Determination of amount of non-federal 
        contribution; maintenance of effort.--
                    (A) Non-Federal contributions required in 
                paragraph (1) may be in cash or in kind, fairly 
                evaluated, including plant, equipment, or 
                services. Amounts provided by the Federal 
                Government, or services assisted or subsidized 
                to any significant extent by the Federal 
                Government, may not be included in determining 
                the amount of such non-Federal contributions.
                    (B) With respect to a State in which the 
                purpose described in subsection (a) is to be 
                carried out, the Secretary, in making a 
                determination of the amount of non-Federal 
                contributions provided under paragraph (1), may 
                include only such contributions as are in 
                excess of the amount of such contributions made 
                by the State toward the collection of data on 
                cancer for the fiscal year preceding the first 
                year for which a grant under subsection (a) is 
                made with respect to the State. The Secretary 
                may decrease the amount of non-Federal 
                contributions that otherwise would have been 
                required by this subsection in those cases in 
                which the State can demonstrate that decreasing 
                such amount is appropriate because of financial 
                hardship.
    (c) Eligibility for Grants.--
            (1) In general.--No grant shall be made by the 
        Secretary under subsection (a) unless an application 
        has been submitted to, and approved by, the Secretary. 
        Such application shall be in such form, submitted in 
        such a manner, and be accompanied by such information, 
        as the Secretary may specify. No such application may 
        be approved unless it contains assurances that the 
        applicant will use the funds provided only for the 
        purposes specified in the approved application and in 
        accordance with the requirements of this section, that 
        the application will establish such fiscal control and 
        fund accounting procedures as may be necessary to 
        assure proper disbursement and accounting of Federal 
        funds paid to the applicant under subsection (a) of 
        this section, and that the applicant will comply with 
        the peer review requirements under sections 491 and 
        492.
            (2) Assurances.--Each applicant, prior to receiving 
        Federal funds under subsection (a), shall provide 
        assurances satisfactory to the Secretary that the 
        applicant will--
                    (A) provide for the establishment of a 
                registry in accordance with subsection (a);
                    (B) comply with appropriate standards of 
                completeness, timeliness, and quality of 
                population-based cancer registry data;
                    (C) provide for the annual publication of 
                reports of cancer data under subsection (a); 
                and
                    (D) provide for the authorization under 
                State law of the statewide cancer registry, 
                including promulgation of regulations 
                providing--
                            (i) a means to assure complete 
                        reporting of cancer cases (as described 
                        in subsection (a)) to the statewide 
                        cancer registry by hospitals or other 
                        facilities providing screening, 
                        diagnostic or therapeutic services to 
                        patients with respect to cancer;
                            (ii) a means to assure the complete 
                        reporting of cancer cases (as defined 
                        in subsection (a)) to the statewide 
                        cancer registry by physicians, 
                        surgeons, and all other health care 
                        practitioners diagnosing or providing 
                        treatment for cancer patients, except 
                        for cases directly referred to or 
                        previously admitted to a hospital or 
                        other facility providing screening, 
                        diagnostic or therapeutic services to 
                        patients in that State and reported by 
                        those facilities;
                            (iii) a means for the statewide 
                        cancer registry to access all records 
                        of physicians and surgeons, hospitals, 
                        outpatient clinics, nursing homes, and 
                        all other facilities, individuals, or 
                        agencies providing such services to 
                        patients which would identify cases of 
                        cancer or would establish 
                        characteristics of the cancer, 
                        treatment of the cancer, or medical 
                        status of any identified patient;
                            (iv) for the reporting of cancer 
                        case data to the statewide cancer 
                        registry in such a format, with such 
                        data elements, and in accordance with 
                        such standards of quality timeliness 
                        and completeness, as may be established 
                        by the Secretary;
                            (v) for the protection of the 
                        confidentiality of all cancer case data 
                        reported to the statewide cancer 
                        registry, including a prohibition on 
                        disclosure to any person of information 
                        reported to the statewide cancer 
                        registry that identifies, or could lead 
                        to the identification of, an individual 
                        cancer patient, except for disclosure 
                        to other State cancer registries and 
                        local and State health officers;
                            (vi) for a means by which 
                        confidential case data may in 
                        accordance with State law be disclosed 
                        to cancer researchers for the purposes 
                        of cancer prevention, control and 
                        research;
                            (vii) for the authorization or the 
                        conduct, by the statewide cancer 
                        registry or other persons and 
                        organizations, of studies utilizing 
                        statewide cancer registry data, 
                        including studies of the sources and 
                        causes of cancer, evaluations of the 
                        cost, quality, efficacy, and 
                        appropriateness of diagnostic, 
                        therapeutic, rehabilitative, and 
                        preventative services and programs 
                        relating to cancer, and any other 
                        clinical, epidemiological, or other 
                        cancer research; and
                            (viii) for protection for 
                        individuals complying with the law, 
                        including provisions specifying that no 
                        person shall be held liable in any 
                        civil action with respect to a cancer 
                        case report provided to the statewide 
                        cancer registry, or with respect to 
                        access to cancer case information 
                        provided to the statewide cancer 
                        registry.
    (d) Relationship to Certain Programs.--
            (1) In general.--This section may not be construed 
        to act as a replacement for or diminishment of the 
        program carried out by the Director of the National 
        Cancer Institute and designated by such Director as the 
        Surveillance, Epidemiology, and End Results Program 
        (SEER).
            (2) Supplanting of activities.--In areas where both 
        such programs exist, the Secretary shall ensure that 
        SEER support is not supplanted and that any additional 
        activities are consistent with the guidelines provided 
        for in subsection (c)(2) (C) and (D) and are 
        appropriately coordinated with the existing SEER 
        program.
            (3) Transfer of responsibility.--The Secretary may 
        not transfer administration responsibility for such 
        SEER program from such Director.
            (4) Coordination.--To encourage the greatest 
        possible efficiency and effectiveness of Federally 
        supported efforts with respect to the activities 
        described in this subsection, the Secretary shall take 
        steps to assure the appropriate coordination of 
        programs supported under this part with existing 
        Federally supported cancer registry programs.
    (e) Requirement Regarding Certain Study on Breast Cancer.--
In the case of a grant under subsection (a) to any State 
specified in subsection (b) of section 399E, the Secretary may 
establish such conditions regarding the receipt of the grant as 
the Secretary determines are necessary to facilitate the 
collection of data for the study carried out under such 
section.

SEC. 399C. [280E-1] PLANNING GRANTS REGARDING REGISTRIES.

    (a) In General.--
            (1) States.--The Secretary, acting through the 
        Director of the Centers for Disease Control, may make 
        grants to States for the purpose of developing plans 
        that meet the assurances required by the Secretary 
        under section 399B(c)(2).
            (2) Other entities.--For the purpose described in 
        paragraph (1), the Secretary may make grants to public 
        entities other than States and to nonprofit private 
        entities. Such a grant may be made to an entity only if 
        the State in which the purpose is to be carried out has 
        certified that the State approves the entity as 
        qualified to carry out the purpose.
    (b) Application.--The Secretary may make a grant under 
subsection (a) only if an application for the grant is 
submitted to the Secretary, the application contains the 
certification required in subsection (a)(2) (if the application 
is for a grant under such subsection), and the application is 
in such form, is made in such manner, and contains such 
agreements, assurances, and information as the Secretary 
determines to be necessary to carry out this section.

SEC. 399D. [280E-2] TECHNICAL ASSISTANCE IN OPERATIONS OF STATEWIDE 
                    CANCER REGISTRIES.

    The Secretary, acting through the Director of the Centers 
for Disease Control, may, directly or through grants and 
contracts, or both, provide technical assistance to the States 
in the establishment and operation of statewide registries, 
including assistance in the development of model legislation 
for statewide cancer registries and assistance in establishing 
a computerized reporting and data processing system.

SEC. 399E. [280E-3] STUDY IN CERTAIN STATES TO DETERMINE THE FACTORS 
                    CONTRIBUTING TO THE ELEVATED BREAST CANCER 
                    MORTALITY RATES.

    (a) In General.--Subject to subsections (c) and (d), the 
Secretary, acting through the Director of the National Cancer 
Institute, shall conduct a study for the purpose of determining 
the factors contributing to the fact that breast cancer 
mortality rates in the States specified in subsection (b) are 
elevated compared to rates in other States.
    (b) Relevant States.--The States referred to in subsection 
(a) are Connecticut, Delaware, Maryland, Massachusetts, New 
Hampshire, New Jersey, New York, Rhode Island, Vermont, and the 
District of Columbia.
    (c) Cooperation of State.--The Secretary may conduct the 
study required in subsection (a) in a State only if the State 
agrees to cooperate with the Secretary in the conduct of the 
study, including providing information from any registry 
operated by the State pursuant to section 399B(a).
    (d) Planning, Commencement, and Duration.--The Secretary 
shall, during each of the fiscal years 1993 and 1994, develop a 
plan for conducting the study required in subsection (a). The 
study shall be initiated by the Secretary not later than fiscal 
year 1994, and the collection of data under the study may 
continue through fiscal year 1998.

SEC. 399E-1. [280E-3A] NATIONAL CHILDHOOD CANCER REGISTRY.

    (a) In General.--The Secretary, acting through the Director 
of the Centers for Disease Control and Prevention, shall award 
a grant to enhance and expand infrastructure to track the 
epidemiology of pediatric cancer into a comprehensive 
nationwide registry of actual occurrences of pediatric cancer. 
Such registry shall be updated to include an actual occurrence 
within weeks of the date of such occurrence.
    (b) Informed Consent and Privacy Requirements and 
Coordination With Existing Programs.--The registry established 
pursuant to subsection (a) shall be subject to section 552a of 
title 5, United States Code, the regulations promulgated under 
section 264(c) of the Health Insurance Portability and 
Accountability Act of 1996, applicable Federal and State 
informed consent regulations, any other applicable Federal and 
State laws relating to the privacy of patient information, and 
section 399B(d)(4) of this Act.

SEC. 399F. [280E-4] AUTHORIZATION OF APPROPRIATIONS.

    (a) Registries.--For the purpose of carrying out this part 
(other than section 399E-1), there are authorized to be 
appropriated $30,000,000 for fiscal year 1994, and such sums as 
may be necessary for each of the fiscal years 1995 through 
2003. Of the amounts appropriated under the preceding sentence 
for any such fiscal year, the Secretary may obligate not more 
than 25 percent for carrying out section 399C, and not more 
than 10 percent may be expended for assessing the accuracy, 
completeness and quality of data collected, and not more than 
10 percent of which is to be expended under section 399D.
    (b) Breast Cancer Study.--Of the amounts appropriated for 
the National Cancer Institute under subpart 1 of part C of 
title IV for any fiscal year in which the study required in 
section 399K \1\ is being carried out, the Secretary shall 
expend not less than $1,000,000 for the study.
---------------------------------------------------------------------------
    \1\ Probably should be a reference to section 399E. Section 
502(2)(D)(iii) of Public Law 106-310 (114 Stat. 1115) provides that 
subsection (b) above is amended by striking ``subsection 399K'' and 
inserting ``section 399E''. The amendment cannot be executed because 
the term to be struck does not appear in subsection (b). (Compare 
``subsection 399K'' and ``section 399K''.)
---------------------------------------------------------------------------

  Part N--National Foundation for the Centers for Disease Control and 
                               Prevention

SEC. 399G. [280E-11] ESTABLISHMENT AND DUTIES OF FOUNDATION.

    (a) In General.--There shall be established in accordance 
with this section a nonprofit private corporation to be known 
as the National Foundation for the Centers for Disease Control 
and Prevention (in this part referred to as the 
``Foundation''). The Foundation shall not be an agency or 
instrumentality of the Federal Government, and officers, 
employees, and members of the board of the Foundation shall not 
be officers or employees of the Federal Government.
    (b) Purpose of Foundation.--The purpose of the Foundation 
shall be to support and carry out activities for the prevention 
and control of diseases, disorders, injuries, and disabilities, 
and for promotion of public health.
    (c) Endowment Fund.--
            (1) In general.--In carrying out subsection (b), 
        the Foundation shall establish a fund for providing 
        endowments for positions that are associated with the 
        Centers for Disease Control and Prevention and 
        dedicated to the purpose described in such subsection. 
        Subject to subsection (f)(1)(B), the fund shall consist 
        of such donations as may be provided by non-Federal 
        entities and such non-Federal assets of the Foundation 
        (including earnings of the Foundation and the fund) as 
        the Foundation may elect to transfer to the fund.
            (2) Authorized expenditures of fund.--The provision 
        of endowments under paragraph (1) shall be the 
        exclusive function of the fund established under such 
        paragraph. Such endowments may be expended only for the 
        compensation of individuals holding the positions, for 
        staff, equipment, quarters, travel, and other 
        expenditures that are appropriate in supporting the 
        positions, and for recruiting individuals to hold the 
        positions endowed by the fund.
    (d) Certain Activities of Foundation.--In carrying out 
subsection (b), the Foundation may provide for the following 
with respect to the purpose described in such subsection:
            (1) Programs of fellowships for State and local 
        public health officials to work and study in 
        association with the Centers for Disease Control and 
        Prevention.
            (2) Programs of international arrangements to 
        provide opportunities for public health officials of 
        other countries to serve in public health capacities in 
        the United States in association with the Centers for 
        Disease Control and Prevention or elsewhere, or 
        opportunities for employees of such Centers (or other 
        public health officials in the United States) to serve 
        in such capacities in other countries, or both.
            (3) Studies, projects, and research (which may 
        include applied research on the effectiveness of 
        prevention activities, demonstration projects, and 
        programs and projects involving international, Federal, 
        State, and local governments).
            (4) Forums for government officials and appropriate 
        private entities to exchange information. Participants 
        in such forums may include institutions of higher 
        education and appropriate international organizations.
            (5) Meetings, conferences, courses, and training 
        workshops.
            (6) Programs to improve the collection and analysis 
        of data on the health status of various populations.
            (7) Programs for writing, editing, printing, and 
        publishing of books and other materials.
            (8) Other activities to carry out the purpose 
        described in subsection (b).
    (e) General Structure of Foundation; Nonprofit Status.--
            (1) Board of directors.--The Foundation shall have 
        a board of directors (in this part referred to as the 
        ``Board''), which shall be established and conducted in 
        accordance with subsection (f). The Board shall 
        establish the general policies of the Foundation for 
        carrying out subsection (b), including the 
        establishment of the bylaws of the Foundation.
            (2) Executive director.--The Foundation shall have 
        an executive director (in this part referred to as the 
        ``Director''), who shall be appointed by the Board, who 
        shall serve at the pleasure of the Board, and for whom 
        the Board shall establish the rate of compensation. 
        Subject to compliance with the policies and bylaws 
        established by the Board pursuant to paragraph (1), the 
        Director shall be responsible for the daily operations 
        of the Foundation in carrying out subsection (b).
            (3) Nonprofit status.--In carrying out subsection 
        (b), the Board shall establish such policies and bylaws 
        under paragraph (1), and the Director shall carry out 
        such activities under paragraph (2), as may be 
        necessary to ensure that the Foundation maintains 
        status as an organization that--
                    (A) is described in subsection (c)(3) of 
                section 501 of the Internal Revenue Code of 
                1986; and
                    (B) is, under subsection (a) of such 
                section, exempt from taxation.
    (f) Board of Directors.--
            (1) Certain bylaws.--
                    (A) In establishing bylaws under subsection 
                (e)(1), the Board shall ensure that the bylaws 
                of the Foundation include bylaws for the 
                following:
                            (i) Policies for the selection of 
                        the officers, employees, agents, and 
                        contractors of the Foundation.
                            (ii) Policies, including ethical 
                        standards, for the acceptance and 
                        disposition of donations to the 
                        Foundation and for the disposition of 
                        the assets of the Foundation.
                            (iii) Policies for the conduct of 
                        the general operations of the 
                        Foundation.
                            (iv) Policies for writing, editing, 
                        printing, and publishing of books and 
                        other materials, and the acquisition of 
                        patents and licenses for devices and 
                        procedures developed by the Foundation.
                    (B) In establishing bylaws under subsection 
                (e)(1), the Board shall ensure that the bylaws 
                of the Foundation (and activities carried out 
                under the bylaws) do not--
                            (i) reflect unfavorably upon the 
                        ability of the Foundation, or the 
                        Centers for Disease Control and 
                        Prevention, to carry out its 
                        responsibilities or official duties in 
                        a fair and objective manner; or
                            (ii) compromise, or appear to 
                        compromise, the integrity of any 
                        governmental program or any officer or 
                        employee involved in such program.
            (2) Composition.--
                    (A) Subject to subparagraph (B), the Board 
                shall be composed of 7 individuals, appointed 
                in accordance with paragraph (4), who 
                collectively possess education or experience 
                appropriate for representing the general field 
                of public health, the general field of 
                international health, and the general public. 
                Each such individual shall be a voting member 
                of the Board.
                    (B) The Board may, through amendments to 
                the bylaws of the Foundation, provide that the 
                number of members of the Board shall be a 
                greater number than the number specified in 
                subparagraph (A).
            (3) Chair.--The Board shall, from among the members 
        of the Board, designate an individual to serve as the 
        chair of the Board (in this subsection referred to as 
        the ``Chair'').
            (4) Appointments, vacancies, and terms.--Subject to 
        subsection (j) (regarding the initial membership of the 
        Board), the following shall apply to the Board:
                    (A) Any vacancy in the membership of the 
                Board shall be filled by appointment by the 
                Board, after consideration of suggestions made 
                by the Chair and the Director regarding the 
                appointments. Any such vacancy shall be filled 
                not later than the expiration of the 180-day 
                period beginning on the date on which the 
                vacancy occurs.
                    (B) The term of office of each member of 
                the Board appointed under subparagraph (A) 
                shall be 5 years. A member of the Board may 
                continue to serve after the expiration of the 
                term of the member until the expiration of the 
                180-day period beginning on the date on which 
                the term of the member expires.
                    (C) A vacancy in the membership of the 
                Board shall not affect the power of the Board 
                to carry out the duties of the Board. If a 
                member of the Board does not serve the full 
                term applicable under subparagraph (B), the 
                individual appointed to fill the resulting 
                vacancy shall be appointed for the remainder of 
                the term of the predecessor of the individual.
            (5) Compensation.--Members of the Board may not 
        receive compensation for service on the Board. The 
        members may be reimbursed for travel, subsistence, and 
        other necessary expenses incurred in carrying out the 
        duties of the Board.
    (g) Certain Responsibilities of Executive Director.--In 
carrying out subsection (e)(2), the Director shall carry out 
the following functions:
            (1) Hire, promote, compensate, and discharge 
        officers and employees of the Foundation, and define 
        the duties of the officers and employees.
            (2) Accept and administer donations to the 
        Foundation, and administer the assets of the 
        Foundation.
            (3) Establish a process for the selection of 
        candidates for holding endowed positions under 
        subsection (c).
            (4) Enter into such financial agreements as are 
        appropriate in carrying out the activities of the 
        Foundation.
            (5) Take such action as may be necessary to acquire 
        patents and licenses for devices and procedures 
        developed by the Foundation and the employees of the 
        Foundation.
            (6) Adopt, alter, and use a corporate seal, which 
        shall be judicially noticed.
            (7) Commence and respond to judicial proceedings in 
        the name of the Foundation.
            (8) Other functions that are appropriate in the 
        determination of the Director.
    (h) General Provisions.--
            (1) Authority for accepting funds.--The Director of 
        the Centers for Disease Control and Prevention may 
        accept and utilize, on behalf of the Federal 
        Government, any gift, donation, bequest, or devise of 
        real or personal property from the Foundation for the 
        purpose of aiding or facilitating the work of such 
        Centers. Funds may be accepted and utilized by such 
        Director under the preceding sentence without regard to 
        whether the funds are designated as general-purpose 
        funds or special-purpose funds.
            (2) Authority for acceptance of voluntary 
        services.--
                    (A) The Director of the Centers for Disease 
                Control and Prevention may accept, on behalf of 
                the Federal Government, any voluntary services 
                provided to such Centers by the Foundation for 
                the purpose of aiding or facilitating the work 
                of such Centers. In the case of an individual, 
                such Director may accept the services provided 
                under the preceding sentence by the individual 
                until such time as the private funding for such 
                individual ends.
                    (B) The limitation established in 
                subparagraph (A) regarding the period of time 
                in which services may be accepted applies to 
                each individual who is not an employee of the 
                Federal Government and who serves in 
                association with the Centers for Disease 
                Control and Prevention pursuant to financial 
                support from the Foundation.
            (3) Administrative control.--No officer, employee, 
        or member of the Board of the Foundation may exercise 
        any administrative or managerial control over any 
        Federal employee.
            (4) Applicability of certain standards to non-
        federal employees.--In the case of any individual who 
        is not an employee of the Federal Government and who 
        serves in association with the Centers for Disease 
        Control and Prevention pursuant to financial support 
        from the Foundation, the Foundation shall negotiate a 
        memorandum of understanding with the individual and the 
        Director of the Centers for Disease Control and 
        Prevention specifying that the individual--
                    (A) shall be subject to the ethical and 
                procedural standards regulating Federal 
                employment, scientific investigation, and 
                research findings (including publications and 
                patents) that are required of individuals 
                employed by the Centers for Disease Control and 
                Prevention, including standards under this Act, 
                the Ethics in Government Act, and the 
                Technology Transfer Act; and
                    (B) shall be subject to such ethical and 
                procedural standards under chapter 11 of title 
                18, United States Code (relating to conflicts 
                of interest), as the Director of such Centers 
                determines is appropriate, except such 
                memorandum may not provide that the individual 
                shall be subject to the standards of section 
                209 of such chapter.
            (5) Financial conflicts of interest.--Any 
        individual who is an officer, employee, or member of 
        the Board of the Foundation may not directly or 
        indirectly participate in the consideration or 
        determination by the Foundation of any question 
        affecting--
                    (A) any direct or indirect financial 
                interest of the individual; or
                    (B) any direct or indirect financial 
                interest of any business organization or other 
                entity of which the individual is an officer or 
                employee or in which the individual has a 
                direct or indirect financial interest.
            (6) Audits; availability of records.--The 
        Foundation shall--
                    (A) provide for biennial audits of the 
                financial condition of the Foundation; and
                    (B) make such audits, and all other 
                records, documents, and other papers of the 
                Foundation, available to the Secretary and the 
                Comptroller General of the United States for 
                examination or audit.
            (7) Reports.--
                    (A) Not later than February 1 of each 
                fiscal year, the Foundation shall publish a 
                report describing the activities of the 
                Foundation during the preceding fiscal year. 
                Each such report shall include for the fiscal 
                year involved a comprehensive statement of the 
                operations, activities, financial condition, 
                and accomplishments of the Foundation, 
                including an accounting of the use of amounts 
                provided for under subsection (i).
                    (B) With respect to the financial condition 
                of the Foundation, each report under 
                subparagraph (A) shall include the source, and 
                a description of, all gifts to the Foundation 
                of real or personal property, and the source 
                and amount of all gifts to the Foundation of 
                money. Each such report shall include a 
                specification of any restrictions on the 
                purposes for which gifts to the Foundation may 
                be used.
                    (C) The Foundation shall make copies of 
                each report submitted under subparagraph (A) 
                available--
                            (i) for public inspection, and 
                        shall upon request provide a copy of 
                        the report to any individual for a 
                        charge not to exceed the cost of 
                        providing the copy; and
                            (ii) to the appropriate committees 
                        of Congress.
            (8) Liaison from centers for disease control and 
        prevention.--The Director of the Centers for Disease 
        Control and Prevention shall serve as the liaison 
        representative of such Centers to the Board and the 
        Foundation.
    (i) Federal Funding.--
            (1) Authority for annual grants.--
                    (A) The Secretary, acting through the 
                Director of the Centers for Disease Control and 
                Prevention, shall--
                            (i) for fiscal year 1993, make a 
                        grant to an entity described in 
                        subsection (j)(9) (relating to the 
                        establishment of a committee to 
                        establish the Foundation);
                            (ii) for fiscal year 1994, make a 
                        grant to the committee established 
                        under such subsection, or if the 
                        Foundation has been established, to the 
                        Foundation; and
                            (iii) for fiscal year 1995 and each 
                        subsequent fiscal year, make a grant to 
                        the Foundation.
                    (B) A grant under subparagraph (A) may be 
                expended--
                            (i) in the case of an entity 
                        receiving the grant under subparagraph 
                        (A)(i), only for the purpose of 
                        carrying out the duties established in 
                        subsection (j)(9) for the entity;
                            (ii) in the case of the committee 
                        established under such subsection, only 
                        for the purpose of carrying out the 
                        duties established in subsection (j) 
                        for the committee; and
                            (iii) in the case of the 
                        Foundation, only for the purpose of the 
                        administrative expenses of the 
                        Foundation.
                    (C) A grant under subparagraph (A) may not 
                be expended to provide amounts for the fund 
                established under subsection (c).
                    (D) For the purposes described in 
                subparagraph (B)--
                            (i) any portion of the grant made 
                        under subparagraph (A)(i) for fiscal 
                        year 1993 that remains unobligated 
                        after the entity receiving the grant 
                        completes the duties established in 
                        subsection (j)(9) for the entity shall 
                        be available to the committee 
                        established under such subsection; and
                            (ii) any portion of a grant under 
                        subparagraph (A) made for fiscal year 
                        1993 or 1994 that remains unobligated 
                        after such committee completes the 
                        duties established in such subsection 
                        for the committee shall be available to 
                        the Foundation.
            (2) Funding for grants.--
                    (A) For the purpose of grants under 
                paragraph (1), there is authorized to be 
                appropriated $1,250,000 for each fiscal year.
                    (B) For the purpose of grants under 
                paragraph (1), the Secretary may for each 
                fiscal year make available not less than 
                $500,000, and not more than $1,250,000 from the 
                amounts appropriated for the fiscal year for 
                the programs of the Department of Health and 
                Human Services. Such amounts may be made 
                available without regard to whether amounts 
                have been appropriated under subparagraph (A).
            (3) Certain restriction.--If the Foundation 
        receives Federal funds for the purpose of serving as a 
        fiscal intermediary between Federal agencies, the 
        Foundation may not receive such funds for the indirect 
        costs of carrying out such purpose in an amount 
        exceeding 10 percent of the direct costs of carrying 
        out such purpose. The preceding sentence may not be 
        construed as authorizing the expenditure of any grant 
        under paragraph (1) for such purpose.
            (4) Support services.--The Director of the Centers 
        for Disease Control and Prevention may provide 
        facilities, utilities, and support services to the 
        Foundation if it is determined by the Director to be 
        advantageous to the programs of such Centers.
    (j) Committee for Establishment of Foundation.--
            (1) In general.--There shall be established in 
        accordance with this subsection a committee to carry 
        out the functions described in paragraph (2) (which 
        committee is referred to in this subsection as the 
        ``Committee'').
            (2) Functions.--The functions referred to in 
        paragraph (1) for the Committee are as follows:
                    (A) To carry out such activities as may be 
                necessary to incorporate the Foundation under 
                the laws of the State involved, including 
                serving as incorporators for the Foundation. 
                Such activities shall include ensuring that the 
                articles of incorporation for the Foundation 
                require that the Foundation be established and 
                operated in accordance with the applicable 
                provisions of this part (or any successor to 
                this part), including such provisions as may be 
                in effect pursuant to amendments enacted after 
                the date of the enactment of the Preventive 
                Health Amendments of 1992 \1\.
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    \1\ Enacted October 27, 1992.
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                    (B) To ensure that the Foundation qualifies 
                for and maintains the status described in 
                subsection (e)(3) (regarding taxation).
                    (C) To establish the general policies and 
                initial bylaws of the Foundation, which bylaws 
                shall include the bylaws described in 
                subsections (e)(3) and (f)(1).
                    (D) To provide for the initial operation of 
                the Foundation, including providing for 
                quarters, equipment, and staff.
                    (E) To appoint the initial members of the 
                Board in accordance with the requirements 
                established in subsection (f)(2)(A) for the 
                composition of the Board, and in accordance 
                with such other qualifications as the Committee 
                may determine to be appropriate regarding such 
                composition. Of the members so appointed--
                            (i) 2 shall be appointed to serve 
                        for a term of 3 years;
                            (ii) 2 shall be appointed to serve 
                        for a term of 4 years; and
                            (iii) 3 shall be appointed to serve 
                        for a term of 5 years.
            (3) Completion of functions of committee; initial 
        meeting of board.--
                    (A) The Committee shall complete the 
                functions required in paragraph (1) not later 
                than September 30, 1994. The Committee shall 
                terminate upon the expiration of the 30-day 
                period beginning on the date on which the 
                Secretary determines that the functions have 
                been completed.
                    (B) The initial meeting of the Board shall 
                be held not later than November 1, 1994.
            (4) Composition.--The Committee shall be composed 
        of 5 members, each of whom shall be a voting member. Of 
        the members of the Committee--
                    (A) no fewer than 2 shall have broad, 
                general experience in public health; and
                    (B) no fewer than 2 shall have broad, 
                general experience in nonprofit private 
                organizations (without regard to whether the 
                individuals have experience in public health).
            (5) Chair.--The Committee shall, from among the 
        members of the Committee, designate an individual to 
        serve as the chair of the Committee.
            (6) Terms; vacancies.--The term of members of the 
        Committee shall be for the duration of the Committee. A 
        vacancy in the membership of the Committee shall not 
        affect the power of the Committee to carry out the 
        duties of the Committee. If a member of the Committee 
        does not serve the full term, the individual appointed 
        to fill the resulting vacancy shall be appointed for 
        the remainder of the term of the predecessor of the 
        individual.
            (7) Compensation.--Members of the Committee may not 
        receive compensation for service on the Committee. 
        Members of the Committee may be reimbursed for travel, 
        subsistence, and other necessary expenses incurred in 
        carrying out the duties of the Committee.
            (8) Committee support.--The Director of the Centers 
        for Disease Control and Prevention may, from amounts 
        available to the Director for the general 
        administration of such Centers, provide staff and 
        financial support to assist the Committee with carrying 
        out the functions described in paragraph (2). In 
        providing such staff and support, the Director may both 
        detail employees and contract for assistance.
            (9) Grant for establishment of committee.--
                    (A) With respect to a grant under paragraph 
                (1)(A)(i) of subsection (i) for fiscal year 
                1993, an entity described in this paragraph is 
                a private nonprofit entity with significant 
                experience in domestic and international issues 
                of public health. Not later than 180 days after 
                the date of the enactment of the Preventive 
                Health Amendments of 1992 \1\, the Secretary 
                shall make the grant to such an entity (subject 
                to the availability of funds under paragraph 
                (2) of such subsection).
---------------------------------------------------------------------------
    \1\ Enacted October 27, 1992.
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                    (B) The grant referred to in subparagraph 
                (A) may be made to an entity only if the entity 
                agrees that--
                            (i) the entity will establish a 
                        committee that is composed in 
                        accordance with paragraph (4); and
                            (ii) the entity will not select an 
                        individual for membership on the 
                        Committee unless the individual agrees 
                        that the Committee will operate in 
                        accordance with each of the provisions 
                        of this subsection that relate to the 
                        operation of the Committee.
                    (C) The Secretary may make a grant referred 
                to in subparagraph (A) only if the applicant 
                for the grant makes an agreement that the grant 
                will not be expended for any purpose other than 
                carrying out subparagraph (B). Such a grant may 
                be made only if an application for the grant is 
                submitted to the Secretary containing such 
                agreement, and the application is in such form, 
                is made in such manner, and contains such other 
                agreements and such assurances and information 
                as the Secretary determines to be necessary to 
                carry out this paragraph.

     PART O--FETAL ALCOHOL SYNDROME PREVENTION AND SERVICES PROGRAM

SEC. 399H. [280F] ESTABLISHMENT OF FETAL ALCOHOL SYNDROME PREVENTION 
                    AND SERVICES PROGRAM.

    (a) Fetal Alcohol Syndrome Prevention, Intervention and 
Services Delivery Program.--The Secretary shall establish a 
comprehensive Fetal Alcohol Syndrome and Fetal Alcohol Effect 
prevention, intervention and services delivery program that 
shall include--
            (1) an education and public awareness program to 
        support, conduct, and evaluate the effectiveness of--
                    (A) educational programs targeting medical 
                schools, social and other supportive services, 
                educators and counselors and other service 
                providers in all phases of childhood 
                development, and other relevant service 
                providers, concerning the prevention, 
                identification, and provision of services for 
                children, adolescents and adults with Fetal 
                Alcohol Syndrome and Fetal Alcohol Effect;
                    (B) strategies to educate school-age 
                children, including pregnant and high risk 
                youth, concerning Fetal Alcohol Syndrome and 
                Fetal Alcohol Effect;
                    (C) public and community awareness programs 
                concerning Fetal Alcohol Syndrome and Fetal 
                Alcohol Effect; and
                    (D) strategies to coordinate information 
                and services across affected community 
                agencies, including agencies providing social 
                services such as foster care, adoption, and 
                social work, medical and mental health 
                services, and agencies involved in education, 
                vocational training and civil and criminal 
                justice;
            (2) a prevention and diagnosis program to support 
        clinical studies, demonstrations and other research as 
        appropriate to--
                    (A) develop appropriate medical diagnostic 
                methods for identifying Fetal Alcohol Syndrome 
                and Fetal Alcohol Effect; and
                    (B) develop effective prevention services 
                and interventions for pregnant, alcohol-
                dependent women; and
            (3) an applied research program concerning 
        intervention and prevention to support and conduct 
        service demonstration projects, clinical studies and 
        other research models providing advocacy, educational 
        and vocational training, counseling, medical and mental 
        health, and other supportive services, as well as 
        models that integrate and coordinate such services, 
        that are aimed at the unique challenges facing 
        individuals with Fetal Alcohol Syndrome or Fetal 
        Alcohol Effect and their families.
    (b) Grants and Technical Assistance.--The Secretary may 
award grants, cooperative agreements and contracts and provide 
technical assistance to eligible entities described in section 
399I to carry out subsection (a).
    (c) Dissemination of Criteria.--In carrying out this 
section, the Secretary shall develop a procedure for 
disseminating the Fetal Alcohol Syndrome and Fetal Alcohol 
Effect diagnostic criteria developed pursuant to section 705 of 
the ADAMHA Reorganization Act (42 U.S.C. 485n note) to health 
care providers, educators, social workers, child welfare 
workers, and other individuals.
    (d) National Task Force.--
            (1) In general.--The Secretary shall establish a 
        task force to be known as the National Task Force on 
        Fetal Alcohol Syndrome and Fetal Alcohol Effect 
        (referred to in this subsection as the ``Task Force'') 
        to foster coordination among all governmental agencies, 
        academic bodies and community groups that conduct or 
        support Fetal Alcohol Syndrome and Fetal Alcohol Effect 
        research, programs, and surveillance, and otherwise 
        meet the general needs of populations actually or 
        potentially impacted by Fetal Alcohol Syndrome and 
        Fetal Alcohol Effect.
            (2) Membership.--The Task Force established 
        pursuant to paragraph (1) shall--
                    (A) be chaired by an individual to be 
                appointed by the Secretary and staffed by the 
                Administration; and
                    (B) include the Chairperson of the 
                Interagency Coordinating Committee on Fetal 
                Alcohol Syndrome of the Department of Health 
                and Human Services, individuals with Fetal 
                Alcohol Syndrome and Fetal Alcohol Effect, and 
                representatives from advocacy and research 
                organizations such as the Research Society on 
                Alcoholism, the FAS Family Resource Institute, 
                the National Organization of Fetal Alcohol 
                Syndrome, the Arc, the academic community, and 
                Federal, State and local government agencies 
                and offices.
            (3) Functions.--The Task Force shall--
                    (A) advise Federal, State and local 
                programs and research concerning Fetal Alcohol 
                Syndrome and Fetal Alcohol Effect, including 
                programs and research concerning education and 
                public awareness for relevant service 
                providers, school-age children, women at-risk, 
                and the general public, medical diagnosis, 
                interventions for women at-risk of giving birth 
                to children with Fetal Alcohol Syndrome and 
                Fetal Alcohol Effect, and beneficial services 
                for individuals with Fetal Alcohol Syndrome and 
                Fetal Alcohol Effect and their families;
                    (B) coordinate its efforts with the 
                Interagency Coordinating Committee on Fetal 
                Alcohol Syndrome of the Department of Health 
                and Human Services; and
                    (C) report on a biennial basis to the 
                Secretary and relevant committees of Congress 
                on the current and planned activities of the 
                participating agencies.
            (4) Time for appointment.--The members of the Task 
        Force shall be appointed by the Secretary not later 
        than 6 months after the date of enactment of this part.

SEC. 399I. [280F-1] ELIGIBILITY.

    To be eligible to receive a grant, or enter into a 
cooperative agreement or contract under this part, an entity 
shall--
            (1) be a State, Indian tribal government, local 
        government, scientific or academic institution, or 
        nonprofit organization; and
            (2) prepare and submit to the Secretary an 
        application at such time, in such manner, and 
        containing such information as the Secretary may 
        prescribe, including a description of the activities 
        that the entity intends to carry out using amounts 
        received under this part.

SEC. 399J. [280F-2] AUTHORIZATION OF APPROPRIATIONS.

    (a) In General.--There are authorized to be appropriated to 
carry out this part, $27,000,000 for each of the fiscal years 
1999 through 2003.
    (b) Task Force.--From amounts appropriated for a fiscal 
year under subsection (a), the Secretary may use not to exceed 
$2,000,000 of such amounts for the operations of the National 
Task Force under section 399H(d).

SEC. 399K. [280F-3] SUNSET PROVISION.

    This part shall not apply on the date that is 7 years after 
the date on which all members of the National Task Force have 
been appointed under section 399H(d)(1).

                      PART P--ADDITIONAL PROGRAMS

SEC. 399L. [280G] CHILDREN'S ASTHMA TREATMENT GRANTS PROGRAM.

    (a) Authority To Make Grants.--
            (1) In general.--In addition to any other payments 
        made under this Act or title V of the Social Security 
        Act, the Secretary shall award grants to eligible 
        entities to carry out the following purposes:
                    (A) To provide access to quality medical 
                care for children who live in areas that have a 
                high prevalence of asthma and who lack access 
                to medical care.
                    (B) To provide on-site education to 
                parents, children, health care providers, and 
                medical teams to recognize the signs and 
                symptoms of asthma, and to train them in the 
                use of medications to treat asthma and prevent 
                its exacerbations.
                    (C) To decrease preventable trips to the 
                emergency room by making medication available 
                to individuals who have not previously had 
                access to treatment or education in the 
                management of asthma.
                    (D) To provide other services, such as 
                smoking cessation programs, home modification, 
                and other direct and support services that 
                ameliorate conditions that exacerbate or induce 
                asthma.
            (2) Certain projects.--In making grants under 
        paragraph (1), the Secretary may make grants designed 
        to develop and expand the following projects:
                    (A) Projects to provide comprehensive 
                asthma services to children in accordance with 
                the guidelines of the National Asthma Education 
                and Prevention Program (through the National 
                Heart, Lung and Blood Institute), including 
                access to care and treatment for asthma in a 
                community-based setting.
                    (B) Projects to fully equip mobile health 
                care clinics that provide preventive asthma 
                care including diagnosis, physical 
                examinations, pharmacological therapy, skin 
                testing, peak flow meter testing, and other 
                asthma-related health care services.
                    (C) Projects to conduct validated asthma 
                management education programs for patients with 
                asthma and their families, including patient 
                education regarding asthma management, family 
                education on asthma management, and the 
                distribution of materials, including displays 
                and videos, to reinforce concepts presented by 
                medical teams.
            (2) \1\ Award of grants.--
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    \1\So in law. There are two paragraphs (2) in subsection (a). The 
second paragraph (2) and paragraph (3) probably should be redesignated 
as paragraphs (3) and (4), respectively. See section 501 of Public Law 
106-310 (114 Stat. 1113).
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                    (A) Application.--
                            (i) In general.--An eligible entity 
                        shall submit an application to the 
                        Secretary for a grant under this 
                        section in such form and manner as the 
                        Secretary may require.
                            (ii) Required information.--An 
                        application submitted under this 
                        subparagraph shall include a plan for 
                        the use of funds awarded under the 
                        grant and such other information as the 
                        Secretary may require.
                    (B) Requirement.--In awarding grants under 
                this section, the Secretary shall give 
                preference to eligible entities that 
                demonstrate that the activities to be carried 
                out under this section shall be in localities 
                within areas of known or suspected high 
                prevalence of childhood asthma or high asthma-
                related mortality or high rate of 
                hospitalization or emergency room visits for 
                asthma (relative to the average asthma 
                prevalence rates and associated mortality rates 
                in the United States). Acceptable data sets to 
                demonstrate a high prevalence of childhood 
                asthma or high asthma-related mortality may 
                include data from Federal, State, or local 
                vital statistics, claims data under title XIX 
                or XXI of the Social Security Act, other public 
                health statistics or surveys, or other data 
                that the Secretary, in consultation with the 
                Director of the Centers for Disease Control and 
                Prevention, deems appropriate.
            (3) Definition of eligible entity.--For purposes of 
        this section, the term ``eligible entity'' means a 
        public or nonprofit private entity (including a State 
        or political subdivision of a State), or a consortium 
        of any of such entities.
    (b) Coordination With Other Children's Programs.--An 
eligible entity shall identify in the plan submitted as part of 
an application for a grant under this section how the entity 
will coordinate operations and activities under the grant 
with--
            (1) other programs operated in the State that serve 
        children with asthma, including any such programs 
        operated under title V, XIX, or XXI of the Social 
        Security Act; and
            (2) one or more of the following--
                    (A) the child welfare and foster care and 
                adoption assistance programs under parts B and 
                E of title IV of such Act;
                    (B) the head start program established 
                under the Head Start Act (42 U.S.C. 9831 et 
                seq.);
                    (C) the program of assistance under the 
                special supplemental nutrition program for 
                women, infants and children (WIC) under section 
                17 of the Child Nutrition Act of 1966 (42 
                U.S.C. 1786);
                    (D) local public and private elementary or 
                secondary schools; or
                    (E) public housing agencies, as defined in 
                section 3 of the United States Housing Act of 
                1937 (42 U.S.C. 1437a).
    (c) Evaluation.--An eligible entity that receives a grant 
under this section shall submit to the Secretary an evaluation 
of the operations and activities carried out under the grant 
that includes--
            (1) a description of the health status outcomes of 
        children assisted under the grant;
            (2) an assessment of the utilization of asthma-
        related health care services as a result of activities 
        carried out under the grant;
            (3) the collection, analysis, and reporting of 
        asthma data according to guidelines prescribed by the 
        Director of the Centers for Disease Control and 
        Prevention; and
            (4) such other information as the Secretary may 
        require.
    (d) Preference for States That Allow Students to Self-
Administer Medication to Treat Asthma and Anaphylaxis.-- \1\
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    \1\ Subsection (d) was added by section 3(a) of Public Law 108-377 
(118 Stat. 2203), which was enacted October 30, 2004. Section 3(b) of 
such Public Law provides as follows: ``The amendments made by this 
section shall apply only with respect to grants made on or after the 
date that is 9 months after the date of the enactment of this Act.''.
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            (1) Preference.--The Secretary, in making any grant 
        under this section or any other grant that is asthma-
        related (as determined by the Secretary) to a State, 
        shall give preference to any State that satisfies the 
        following:
                    (A) In general.--The State must require 
                that each public elementary school and 
                secondary school in that State will grant to 
                any student in the school an authorization for 
                the self-administration of medication to treat 
                that student's asthma or anaphylaxis, if--
                            (i) a health care practitioner 
                        prescribed the medication for use by 
                        the student during school hours and 
                        instructed the student in the correct 
                        and responsible use of the medication;
                            (ii) the student has demonstrated 
                        to the health care practitioner (or 
                        such practitioner's designee) and the 
                        school nurse (if available) the skill 
                        level necessary to use the medication 
                        and any device that is necessary to 
                        administer such medication as 
                        prescribed;
                            (iii) the health care practitioner 
                        formulates a written treatment plan for 
                        managing asthma or anaphylaxis episodes 
                        of the student and for medication use 
                        by the student during school hours; and
                            (iv) the student's parent or 
                        guardian has completed and submitted to 
                        the school any written documentation 
                        required by the school, including the 
                        treatment plan formulated under clause 
                        (iii) and other documents related to 
                        liability.
                    (B) Scope.--An authorization granted under 
                subparagraph (A) must allow the student 
                involved to possess and use his or her 
                medication--
                            (i) while in school;
                            (ii) while at a school-sponsored 
                        activity, such as a sporting event; and
                            (iii) in transit to or from school 
                        or school-sponsored activities.
                    (C) Duration of authorization.--An 
                authorization granted under subparagraph (A)--
                            (i) must be effective only for the 
                        same school and school year for which 
                        it is granted; and
                            (ii) must be renewed by the parent 
                        or guardian each subsequent school year 
                        in accordance with this subsection.
                    (D) Backup medication.--The State must 
                require that backup medication, if provided by 
                a student's parent or guardian, be kept at a 
                student's school in a location to which the 
                student has immediate access in the event of an 
                asthma or anaphylaxis emergency.
                    (E) Maintenance of information.--The State 
                must require that information described in 
                subparagraphs (A)(iii) and (A)(iv) be kept on 
                file at the student's school in a location 
                easily accessible in the event of an asthma or 
                anaphylaxis emergency.
            (2) Rule of construction.--Nothing in this 
        subsection creates a cause of action or in any other 
        way increases or diminishes the liability of any person 
        under any other law.
            (3) Definitions.--For purposes of this subsection:
                    (A) The terms ``elementary school'' and 
                ``secondary school'' have the meaning given to 
                those terms in section 9101 of the Elementary 
                and Secondary Education Act of 1965.
                    (B) The term ``health care practitioner'' 
                means a person authorized under law to 
                prescribe drugs subject to section 503(b) of 
                the Federal Food, Drug, and Cosmetic Act.
                    (C) The term ``medication'' means a drug as 
                that term is defined in section 201 of the 
                Federal Food, Drug, and Cosmetic Act and 
                includes inhaled bronchodilators and auto-
                injectable epinephrine.
                    (D) The term ``self-administration'' means 
                a student's discretionary use of his or her 
                prescribed asthma or anaphylaxis medication, 
                pursuant to a prescription or written direction 
                from a health care practitioner.
    (e) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2001 through 2005.

SEC. 399M. [280G-1] EARLY DETECTION, DIAGNOSIS, AND TREATMENT REGARDING 
                    HEARING LOSS IN NEWBORNS AND INFANTS.

    (a) Statewide Newborn and Infant Hearing Screening, 
Evaluation and Intervention Programs and Systems.--The 
Secretary, acting through the Administrator of the Health 
Resources and Services Administration, shall make awards of 
grants or cooperative agreements to develop statewide newborn 
and infant hearing screening, evaluation, diagnosis, and 
intervention programs and systems, and to assist in the 
recruitment, retention, education, and training of qualified 
personnel and health care providers, for the following 
purposes:
            (1) To develop and monitor the efficacy of 
        statewide programs and systems for hearing screening of 
        newborns and infants; prompt evaluation and diagnosis 
        of children referred from screening programs; and 
        appropriate educational, audiological, and medical 
        interventions for children identified with hearing 
        loss. Early intervention includes referral to and 
        delivery of information and services by schools and 
        agencies, including community, consumer, and parent-
        based agencies and organizations and other programs 
        mandated by part C of the Individuals with Disabilities 
        Education Act, which offer programs specifically 
        designed to meet the unique language and communication 
        needs of deaf and hard of hearing newborns, infants, 
        toddlers, and children. Programs and systems under this 
        paragraph shall establish and foster family-to-family 
        support mechanisms that are critical in the first 
        months after a child is identified with hearing loss.
            (2) To collect data on statewide newborn and infant 
        hearing screening, evaluation and intervention programs 
        and systems that can be used for applied research, 
        program evaluation and policy development.
            (3) Other activities may include developing 
        efficient models to ensure that newborns and infants 
        who are identified with a hearing loss through 
        screening receive follow-up by a qualified health care 
        provider, and State agencies shall be encouraged to 
        adopt models that effectively increase the rate of 
        occurrence of such follow-up.
    (b) Technical Assistance, Data Management, and Applied 
Research.--
            (1) Centers for disease control and prevention.--
        The Secretary, acting through the Director of the 
        Centers for Disease Control and Prevention, shall make 
        awards of grants or cooperative agreements to provide 
        technical assistance to State agencies to complement an 
        intramural program and to conduct applied research 
        related to newborn and infant hearing screening, 
        evaluation and intervention programs and systems. The 
        program shall develop standardized procedures for data 
        management and program effectiveness and costs, such 
        as--
                    (A) to ensure quality monitoring of newborn 
                and infant hearing loss screening, evaluation, 
                diagnosis, and intervention programs and 
                systems;
                    (B) to provide technical assistance on data 
                collection and management;
                    (C) to study the costs and effectiveness of 
                newborn and infant hearing screening, 
                evaluation and intervention programs and 
                systems conducted by State-based programs in 
                order to answer issues of importance to State 
                and national policymakers;
                    (D) to identify the causes and risk factors 
                for congenital hearing loss;
                    (E) to study the effectiveness of newborn 
                and infant hearing screening, audiologic and 
                medical evaluations and intervention programs 
                and systems by assessing the health, 
                intellectual and social developmental, 
                cognitive, and language status of these 
                children at school age; and
                    (F) to promote the sharing of data 
                regarding early hearing loss with State-based 
                birth defects and developmental disabilities 
                monitoring programs for the purpose of 
                identifying previously unknown causes of 
                hearing loss.
            (2) National institutes of health.--The Director of 
        the National Institutes of Health, acting through the 
        Director of the National Institute on Deafness and 
        Other Communication Disorders, shall for purposes of 
        this section, continue a program of research and 
        development on the efficacy of new screening techniques 
        and technology, including clinical studies of screening 
        methods, studies on efficacy of intervention, and 
        related research.
    (c) Coordination and Collaboration.--
            (1) In general.--In carrying out programs under 
        this section, the Administrator of the Health Resources 
        and Services Administration, the Director of the 
        Centers for Disease Control and Prevention, and the 
        Director of the National Institutes of Health shall 
        collaborate and consult with other Federal agencies; 
        State and local agencies, including those responsible 
        for early intervention services pursuant to title XIX 
        of the Social Security Act (Medicaid Early and Periodic 
        Screening, Diagnosis and Treatment Program); title XXI 
        of the Social Security Act (State Children's Health 
        Insurance Program); title V of the Social Security Act 
        (Maternal and Child Health Block Grant Program); and 
        part C of the Individuals with Disabilities Education 
        Act; consumer groups of and that serve individuals who 
        are deaf and hard-of-hearing and their families; 
        appropriate national medical and other health and 
        education specialty organizations; persons who are deaf 
        and hard-of-hearing and their families; other qualified 
        professional personnel who are proficient in deaf or 
        hard-of-hearing children's language and who possess the 
        specialized knowledge, skills, and attributes needed to 
        serve deaf and hard-of-hearing newborns, infants, 
        toddlers, children, and their families; third-party 
        payers and managed care organizations; and related 
        commercial industries.
            (2) Policy development.--The Administrator of the 
        Health Resources and Services Administration, the 
        Director of the Centers for Disease Control and 
        Prevention, and the Director of the National Institutes 
        of Health shall coordinate and collaborate on 
        recommendations for policy development at the Federal 
        and State levels and with the private sector, including 
        consumer, medical and other health and education 
        professional-based organizations, with respect to 
        newborn and infant hearing screening, evaluation, 
        diagnosis, and intervention programs and systems.
            (3) State early detection, diagnosis, and 
        intervention programs and systems; data collection.--
        The Administrator of the Health Resources and Services 
        Administration and the Director of the Centers for 
        Disease Control and Prevention shall coordinate and 
        collaborate in assisting States to establish newborn 
        and infant hearing screening, evaluation, diagnosis, 
        and intervention programs and systems under subsection 
        (a) and to develop a data collection system under 
        subsection (b).
    (d) Rule of Construction; Religious Accommodation.--Nothing 
in this section shall be construed to preempt or prohibit any 
State law, including State laws which do not require the 
screening for hearing loss of newborn infants or young children 
of parents who object to the screening on the grounds that such 
screening conflicts with the parents' religious beliefs.
    (e) Definitions.--For purposes of this section:
            (1) The term ``audiologic evaluation'' refers to 
        procedures to assess the status of the auditory system; 
        to establish the site of the auditory disorder; the 
        type and degree of hearing loss, and the potential 
        effects of hearing loss on communication; and to 
        identify appropriate treatment and referral options. 
        Referral options should include linkage to State 
        coordinating agencies under part C of the Individuals 
        with Disabilities Education Act or other appropriate 
        agencies, medical evaluation, hearing aid /sensory aid 
        assessment, audiologic rehabilitation treatment, 
        national and local consumer, self-help, parent, and 
        education organizations, and other family-centered 
        services.
            (2) The terms ``audiologic rehabilitation'' and 
        ``audiologic intervention'' refer to procedures, 
        techniques, and technologies to facilitate the 
        receptive and expressive communication abilities of a 
        child with hearing loss.
            (3) The term ``early intervention'' refers to 
        providing appropriate services for the child with 
        hearing loss, including nonmedical services, and 
        ensuring that families of the child are provided 
        comprehensive, consumer- oriented information about the 
        full range of family support, training, information 
        services, and language and communication options and 
        are given the opportunity to consider and obtain the 
        full range of such appropriate services, educational 
        and program placements, and other options for their 
        child from highly qualified providers.
            (4) The term ``medical evaluation by a physician'' 
        refers to key components including history, 
        examination, and medical decision making focused on 
        symptomatic and related body systems for the purpose of 
        diagnosing the etiology of hearing loss and related 
        physical conditions, and for identifying appropriate 
        treatment and referral options.
            (5) The term ``medical intervention'' refers to the 
        process by which a physician provides medical diagnosis 
        and direction for medical and /or surgical treatment 
        options of hearing loss and /or related medical 
        disorder associated with hearing loss.
            (6) The term ``newborn and infant hearing 
        screening'' refers to objective physiologic procedures 
        to detect possible hearing loss and to identify 
        newborns and infants who require further audiologic and 
        medical evaluations.
    (f ) Authorization of Appropriations.--
            (1) Statewide newborn and infant hearing screening, 
        evaluation and intervention programs and systems.--For 
        the purpose of carrying out subsection (a), there are 
        authorized to be appropriated to the Health Resources 
        and Services Administration such sums as may be 
        necessary for fiscal years 2011 through 2015.
            (2) Technical assistance, data management, and 
        applied research; centers for disease control and 
        prevention.--For the purpose of carrying out subsection 
        (b)(1), there are authorized to be appropriated to the 
        Centers for Disease Control and Prevention such sums as 
        may be necessary for fiscal years 2011 through 2015.
            (3) Technical assistance, data management, and 
        applied research; national institute on deafness and 
        other communication disorders.--For the purpose of 
        carrying out subsection (b)(2), there are authorized to 
        be appropriated to the National Institute on Deafness 
        and Other Communication Disorders such sums as may be 
        necessary for fiscal years 2011 through 2015.

SEC. 399N. [280G-2] CHILDHOOD MALIGNANCIES.

    (a) In General.--The Secretary, acting as appropriate 
through the Director of the Centers for Disease Control and 
Prevention and the Director of the National Institutes of 
Health, shall study environmental and other risk factors for 
childhood cancers (including skeletal malignancies, leukemias, 
malignant tumors of the central nervous system, lymphomas, soft 
tissue sarcomas, and other malignant neoplasms) and carry out 
projects to improve outcomes among children with childhood 
cancers and resultant secondary conditions, including limb 
loss, anemia, rehabilitation, and palliative care. Such 
projects shall be carried out by the Secretary directly and 
through awards of grants or contracts.
    (b) Certain Activities.--Activities under subsection (a) 
include--
            (1) the expansion of current demographic data 
        collection and population surveillance efforts to 
        include childhood cancers nationally;
            (2) the development of a uniform reporting system 
        under which treating physicians, hospitals, clinics, 
        and States report the diagnosis of childhood cancers, 
        including relevant associated epidemiological data; and
            (3) support for the National Limb Loss Information 
        Center to address, in part, the primary and secondary 
        needs of persons who experience childhood cancers in 
        order to prevent or minimize the disabling nature of 
        these cancers.
    (c) Coordination of Activities.--The Secretary shall assure 
that activities under this section are coordinated as 
appropriate with other agencies of the Public Health Service 
that carry out activities focused on childhood cancers and limb 
loss.
    (d) Definition.--For purposes of this section, the term 
``childhood cancer'' refers to a spectrum of different 
malignancies that vary by histology, site of disease, origin, 
race, sex, and age. The Secretary may for purposes of this 
section revise the definition of such term to the extent 
determined by the Secretary to be appropriate.
    (e) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2001 through 2005.

SEC. 399O. [280G-3] CONTROLLED SUBSTANCE MONITORING PROGRAM.

    (a) Grants.--
            (1) In general.--Each fiscal year, the Secretary 
        shall award a grant to each State with an application 
        approved under this section to enable the State--
                    (A) to establish and implement a State 
                controlled substance monitoring program; or
                    (B) to make improvements to an existing 
                State controlled substance monitoring program.
            (2) Determination of amount.--
                    (A) Minimum amount.--In making payments 
                under a grant under paragraph (1) for a fiscal 
                year, the Secretary shall allocate to each 
                State with an application approved under this 
                section an amount that equals 1.0 percent of 
                the amount appropriated to carry out this 
                section for that fiscal year.
                    (B) Additional amounts.--In making payments 
                under a grant under paragraph (1) for a fiscal 
                year, the Secretary shall allocate to each 
                State with an application approved under this 
                section an additional amount which bears the 
                same ratio to the amount appropriated to carry 
                out this section for that fiscal year and 
                remaining after amounts are made available 
                under subparagraph (A) as the number of 
                pharmacies of the State bears to the number of 
                pharmacies of all States with applications 
                approved under this section (as determined by 
                the Secretary), except that the Secretary may 
                adjust the amount allocated to a State under 
                this subparagraph after taking into 
                consideration the budget cost estimate for the 
                State's controlled substance monitoring 
                program.
            (3) Term of grants.--Grants awarded under this 
        section shall be obligated in the year in which funds 
        are allotted.
    (b) Development of Minimum Requirements.--Prior to awarding 
a grant under this section, and not later than 6 months after 
the date on which funds are first appropriated to carry out 
this section, after seeking consultation with States and other 
interested parties, the Secretary shall, after publishing in 
the Federal Register proposed minimum requirements and 
receiving public comments, establish minimum requirements for 
criteria to be used by States for purposes of clauses (ii), 
(v), (vi), and (vii) of subsection (c)(1)(A).
    (c) Application Approval Process.--
            (1) In general.--To be eligible to receive a grant 
        under this section, a State shall submit an application 
        to the Secretary at such time, in such manner, and 
        containing such assurances and information as the 
        Secretary may reasonably require. Each such application 
        shall include--
                    (A) with respect to a State that intends to 
                use funds under the grant as provided for in 
                subsection (a)(1)(A)--
                            (i) a budget cost estimate for the 
                        controlled substance monitoring program 
                        to be implemented under the grant;
                            (ii) criteria for security for 
                        information handling and for the 
                        database maintained by the State under 
                        subsection (e) generally including 
                        efforts to use appropriate encryption 
                        technology or other appropriate 
                        technology to protect the security of 
                        such information;
                            (iii) an agreement to adopt health 
                        information interoperability standards, 
                        including health vocabulary and 
                        messaging standards, that are 
                        consistent with any such standards 
                        generated or identified by the 
                        Secretary or his or her designee;
                            (iv) criteria for meeting the 
                        uniform electronic format requirement 
                        of subsection (h);
                            (v) criteria for availability of 
                        information and limitation on access to 
                        program personnel;
                            (vi) criteria for access to the 
                        database, and procedures to ensure that 
                        information in the database is 
                        accurate;
                            (vii) criteria for the use and 
                        disclosure of information, including a 
                        description of the certification 
                        process to be applied to requests for 
                        information under subsection (f);
                            (viii) penalties for the 
                        unauthorized use and disclosure of 
                        information maintained in the State 
                        controlled substance monitoring program 
                        in violation of applicable State law or 
                        regulation;
                            (ix) information on the relevant 
                        State laws, policies, and procedures, 
                        if any, regarding purging of 
                        information from the database; and
                            (x) assurances of compliance with 
                        all other requirements of this section; 
                        or
                    (B) with respect to a State that intends to 
                use funds under the grant as provided for in 
                subsection (a)(1)(B)--
                            (i) a budget cost estimate for the 
                        controlled substance monitoring program 
                        to be improved under the grant;
                            (ii) a plan for ensuring that the 
                        State controlled substance monitoring 
                        program is in compliance with the 
                        criteria and penalty requirements 
                        described in clauses (ii) through 
                        (viii) of subparagraph (A);
                            (iii) a plan to enable the State 
                        controlled substance monitoring program 
                        to achieve interoperability with at 
                        least one other State controlled 
                        substance monitoring program; and
                            (iv) assurances of compliance with 
                        all other requirements of this section 
                        or a statement describing why such 
                        compliance is not feasible or is 
                        contrary to the best interests of 
                        public health in such State.
            (2) State legislation.--As part of an application 
        under paragraph (1), the Secretary shall require a 
        State to demonstrate that the State has enacted 
        legislation or regulations to permit the implementation 
        of the State controlled substance monitoring program 
        and the imposition of appropriate penalties for the 
        unauthorized use and disclosure of information 
        maintained in such program.
            (3) Interoperability.--If a State that submits an 
        application under this subsection geographically 
        borders another State that is operating a controlled 
        substance monitoring program under subsection (a)(1) on 
        the date of submission of such application, and such 
        applicant State has not achieved interoperability for 
        purposes of information sharing between its monitoring 
        program and the monitoring program of such border 
        State, such applicant State shall, as part of the plan 
        under paragraph (1)(B)(iii), describe the manner in 
        which the applicant State will achieve interoperability 
        between the monitoring programs of such States.
            (4) Approval.--If a State submits an application in 
        accordance with this subsection, the Secretary shall 
        approve such application.
            (5) Return of funds.--If the Secretary withdraws 
        approval of a State's application under this section, 
        or the State chooses to cease to implement or improve a 
        controlled substance monitoring program under this 
        section, a funding agreement for the receipt of a grant 
        under this section is that the State will return to the 
        Secretary an amount which bears the same ratio to the 
        overall grant as the remaining time period for 
        expending the grant funds bears to the overall time 
        period for expending the grant (as specified by the 
        Secretary at the time of the grant).
    (d) Reporting Requirements.--In implementing or improving a 
controlled substance monitoring program under this section, a 
State shall comply, or with respect to a State that applies for 
a grant under subsection (a)(1)(B) submit to the Secretary for 
approval a statement of why such compliance is not feasible or 
is contrary to the best interests of public health in such 
State, with the following:
            (1) The State shall require dispensers to report to 
        such State each dispensing in the State of a controlled 
        substance to an ultimate user not later than 1 week 
        after the date of such dispensing.
            (2) The State may exclude from the reporting 
        requirement of this subsection--
                    (A) the direct administration of a 
                controlled substance to the body of an ultimate 
                user;
                    (B) the dispensing of a controlled 
                substance in a quantity limited to an amount 
                adequate to treat the ultimate user involved 
                for 48 hours or less; or
                    (C) the administration or dispensing of a 
                controlled substance in accordance with any 
                other exclusion identified by the Secretary for 
                purposes of this paragraph.
            (3) The information to be reported under this 
        subsection with respect to the dispensing of a 
        controlled substance shall include the following:
                    (A) Drug Enforcement Administration 
                Registration Number (or other identifying 
                number used in lieu of such Registration 
                Number) of the dispenser.
                    (B) Drug Enforcement Administration 
                Registration Number (or other identifying 
                number used in lieu of such Registration 
                Number) and name of the practitioner who 
                prescribed the drug.
                    (C) Name, address, and telephone number of 
                the ultimate user or such contact information 
                of the ultimate user as the Secretary 
                determines appropriate.
                    (D) Identification of the drug by a 
                national drug code number.
                    (E) Quantity dispensed.
                    (F) Number of refills ordered.
                    (G) Whether the drug was dispensed as a 
                refill of a prescription or as a first-time 
                request.
                    (H) Date of the dispensing.
                    (I) Date of origin of the prescription.
                    (J) Such other information as may be 
                required by State law to be reported under this 
                subsection.
            (4) The State shall require dispensers to report 
        information under this section in accordance with the 
        electronic format specified by the Secretary under 
        subsection (h), except that the State may waive the 
        requirement of such format with respect to an 
        individual dispenser that is unable to submit such 
        information by electronic means.
    (e) Database.--In implementing or improving a controlled 
substance monitoring program under this section, a State shall 
comply with the following:
            (1) The State shall establish and maintain an 
        electronic database containing the information reported 
        to the State under subsection (d).
            (2) The database must be searchable by any field or 
        combination of fields.
            (3) The State shall include reported information in 
        the database in a manner consistent with criteria 
        established by the Secretary, with appropriate 
        safeguards for ensuring the accuracy and completeness 
        of the database.
            (4) The State shall take appropriate security 
        measures to protect the integrity of, and access to, 
        the database.
    (f) Use and Disclosure of Information.--
            (1) In general.--Subject to subsection (g), in 
        implementing or improving a controlled substance 
        monitoring program under this section, a State may 
        disclose information from the database established 
        under subsection (e) and, in the case of a request 
        under subparagraph (D), summary statistics of such 
        information, only in response to a request by--
                    (A) a practitioner (or the agent thereof) 
                who certifies, under the procedures determined 
                by the State, that the requested information is 
                for the purpose of providing medical or 
                pharmaceutical treatment or evaluating the need 
                for such treatment to a bona fide current 
                patient;
                    (B) any local, State, or Federal law 
                enforcement, narcotics control, licensure, 
                disciplinary, or program authority, who 
                certifies, under the procedures determined by 
                the State, that the requested information is 
                related to an individual investigation or 
                proceeding involving the unlawful diversion or 
                misuse of a schedule II, III, or IV substance, 
                and such information will further the purpose 
                of the investigation or assist in the 
                proceeding;
                    (C) the controlled substance monitoring 
                program of another State or group of States 
                with whom the State has established an 
                interoperability agreement;
                    (D) any agent of the Department of Health 
                and Human Services, a State medicaid program, a 
                State health department, or the Drug 
                Enforcement Administration who certifies that 
                the requested information is necessary for 
                research to be conducted by such department, 
                program, or administration, respectively, and 
                the intended purpose of the research is related 
                to a function committed to such department, 
                program, or administration by law that is not 
                investigative in nature; or
                    (E) an agent of the State agency or entity 
                of another State that is responsible for the 
                establishment and maintenance of that State's 
                controlled substance monitoring program, who 
                certifies that--
                            (i) the State has an application 
                        approved under this section; and
                            (ii) the requested information is 
                        for the purpose of implementing the 
                        State's controlled substance monitoring 
                        program under this section.
            (2) Drug diversion.--In consultation with 
        practitioners, dispensers, and other relevant and 
        interested stakeholders, a State receiving a grant 
        under subsection (a)--
                    (A) shall establish a program to notify 
                practitioners and dispensers of information 
                that will help identify and prevent the 
                unlawful diversion or misuse of controlled 
                substances; and
                    (B) may, to the extent permitted under 
                State law, notify the appropriate authorities 
                responsible for carrying out drug diversion 
                investigations if the State determines that 
                information in the database maintained by the 
                State under subsection (e) indicates an 
                unlawful diversion or abuse of a controlled 
                substance.
    (g) Limitations.--In implementing or improving a controlled 
substance monitoring program under this section, a State--
            (1) shall limit the information provided pursuant 
        to a valid request under subsection (f)(1) to the 
        minimum necessary to accomplish the intended purpose of 
        the request; and
            (2) shall limit information provided in response to 
        a request under subsection (f)(1)(D) to nonidentifiable 
        information.
    (h) Electronic Format.--The Secretary shall specify a 
uniform electronic format for the reporting, sharing, and 
disclosure of information under this section.
    (i) Rules of Construction.--
            (1) Functions otherwise authorized by law.--Nothing 
        in this section shall be construed to restrict the 
        ability of any authority, including any local, State, 
        or Federal law enforcement, narcotics control, 
        licensure, disciplinary, or program authority, to 
        perform functions otherwise authorized by law.
            (2) No preemption.--Nothing in this section shall 
        be construed as preempting any State law, except that 
        no such law may relieve any person of a requirement 
        otherwise applicable under this Act.
            (3) Additional privacy protections.--Nothing in 
        this section shall be construed as preempting any State 
        from imposing any additional privacy protections.
            (4) Federal privacy requirements.--Nothing in this 
        section shall be construed to supersede any Federal 
        privacy or confidentiality requirement, including the 
        regulations promulgated under section 264(c) of the 
        Health Insurance Portability and Accountability Act of 
        1996 (Public Law 104-191; 110 Stat. 2033) and section 
        543 of the Public Health Service Act.
            (5) No federal private cause of action.--Nothing in 
        this section shall be construed to create a Federal 
        private cause of action.
    (j) Studies and Reports.--
            (1) Implementation report.--
                    (A) In general.--Not later than 180 days 
                after the date of enactment of this section, 
                the Secretary, based on a review of existing 
                State controlled substance monitoring programs 
                and other relevant information, shall determine 
                whether the implementation of such programs has 
                had a substantial negative impact on--
                            (i) patient access to treatment, 
                        including therapy for pain or 
                        controlled substance abuse;
                            (ii) pediatric patient access to 
                        treatment; or
                            (iii) patient enrollment in 
                        research or clinical trials in which, 
                        following the protocol that has been 
                        approved by the relevant institutional 
                        review board for the research or 
                        clinical trial, the patient has 
                        obtained a controlled substance from 
                        either the scientific investigator 
                        conducting such research or clinical 
                        trial or the agent thereof.
                    (B) Additional categories of exclusion.--If 
                the Secretary determines under subparagraph (A) 
                that a substantial negative impact has been 
                demonstrated with regard to one or more of the 
                categories of patients described in such 
                subparagraph, the Secretary shall identify 
                additional appropriate categories of exclusion 
                from reporting as authorized under subsection 
                (d)(2)(C).
            (2) Progress report.--Not later than 3 years after 
        the date on which funds are first appropriated under 
        this section, the Secretary shall--
                    (A) complete a study that--
                            (i) determines the progress of 
                        States in establishing and implementing 
                        controlled substance monitoring 
                        programs under this section;
                            (ii) provides an analysis of the 
                        extent to which the operation of 
                        controlled substance monitoring 
                        programs have reduced inappropriate 
                        use, abuse, or diversion of controlled 
                        substances or affected patient access 
                        to appropriate pain care in States 
                        operating such programs;
                            (iii) determines the progress of 
                        States in achieving interoperability 
                        between controlled substance monitoring 
                        programs, including an assessment of 
                        technical and legal barriers to such 
                        activities and recommendations for 
                        addressing these barriers;
                            (iv) determines the feasibility of 
                        implementing a real-time electronic 
                        controlled substance monitoring 
                        program, including the costs associated 
                        with establishing such a program;
                            (v) provides an analysis of the 
                        privacy protections in place for the 
                        information reported to the controlled 
                        substance monitoring program in each 
                        State receiving a grant for the 
                        establishment or operation of such 
                        program, and any recommendations for 
                        additional requirements for protection 
                        of this information;
                            (vi) determines the feasibility of 
                        implementing technological alternatives 
                        to centralized data storage, such as 
                        peer-to-peer file sharing or data 
                        pointer systems, in controlled 
                        substance monitoring programs and the 
                        potential for such alternatives to 
                        enhance the privacy and security of 
                        individually identifiable data; and
                            (vii) evaluates the penalties that 
                        States have enacted for the 
                        unauthorized use and disclosure of 
                        information maintained in the 
                        controlled substance monitoring 
                        program, and reports on the criteria 
                        used by the Secretary to determine 
                        whether such penalties qualify as 
                        appropriate pursuant to this section; 
                        and
                    (B) submit a report to the Congress on the 
                results of the study.
    (k) Preference.--Beginning 3 years after the date on which 
funds are first appropriated to carry out this section, the 
Secretary, in awarding any competitive grant that is related to 
drug abuse (as determined by the Secretary) and for which only 
States are eligible to apply, shall give preference to any 
State with an application approved under this section. The 
Secretary shall have the discretion to apply such preference to 
States with existing controlled substance monitoring programs 
that meet minimum requirements under this section or to States 
that put forth a good faith effort to meet those requirements 
(as determined by the Secretary).
    (l) Advisory Council.--
            (1) Establishment.--A State may establish an 
        advisory council to assist in the establishment, 
        implementation, or improvement of a controlled 
        substance monitoring program under this section.
            (2) Limitation.--A State may not use amounts 
        received under a grant under this section for the 
        operations of an advisory council established under 
        paragraph (1).
            (3) Sense of congress.--It is the sense of the 
        Congress that, in establishing an advisory council 
        under this subsection, a State should consult with 
        appropriate professional boards and other interested 
        parties.
    (m) Definitions.--For purposes of this section:
            (1) The term ``bona fide patient'' means an 
        individual who is a patient of the practitioner 
        involved.
            (2) The term ``controlled substance'' means a drug 
        that is included in schedule II, III, or IV of section 
        202(c) of the Controlled Substance Act.
            (3) The term ``dispense'' means to deliver a 
        controlled substance to an ultimate user by, or 
        pursuant to the lawful order of, a practitioner, 
        irrespective of whether the dispenser uses the Internet 
        or other means to effect such delivery.
            (4) The term ``dispenser'' means a physician, 
        pharmacist, or other person that dispenses a controlled 
        substance to an ultimate user.
            (5) The term ``interoperability'' with respect to a 
        State controlled substance monitoring program means the 
        ability of the program to electronically share reported 
        information, including each of the required report 
        components described in subsection (d), with another 
        State if the information concerns either the dispensing 
        of a controlled substance to an ultimate user who 
        resides in such other State, or the dispensing of a 
        controlled substance prescribed by a practitioner whose 
        principal place of business is located in such other 
        State.
            (6) The term ``nonidentifiable information'' means 
        information that does not identify a practitioner, 
        dispenser, or an ultimate user and with respect to 
        which there is no reasonable basis to believe that the 
        information can be used to identify a practitioner, 
        dispenser, or an ultimate user.
            (7) The term ``practitioner'' means a physician, 
        dentist, veterinarian, scientific investigator, 
        pharmacy, hospital, or other person licensed, 
        registered, or otherwise permitted, by the United 
        States or the jurisdiction in which he or she practices 
        or does research, to distribute, dispense, conduct 
        research with respect to, administer, or use in 
        teaching or chemical analysis, a controlled substance 
        in the course of professional practice or research.
            (8) The term ``State'' means each of the 50 States 
        and the District of Columbia.
            (9) The term ``ultimate user'' means a person who 
        has obtained from a dispenser, and who possesses, a 
        controlled substance for his or her own use, for the 
        use of a member of his or her household, or for the use 
        of an animal owned by him or her or by a member of his 
        or her household.
    (n) Authorization of Appropriations.--To carry out this 
section, there are authorized to be appropriated--
            (1) $15,000,000 for each of fiscal years 2006 and 
        2007; and
            (2) $10,000,000 for each of fiscal years 2008, 
        2009, and 2010.

SEC. 399P. [280G-4] GRANTS TO FOSTER PUBLIC HEALTH RESPONSES TO 
                    DOMESTIC VIOLENCE, DATING VIOLENCE, SEXUAL ASSAULT, 
                    AND STALKING.

    (a) Authority to Award Grants.--
            (1) In general.--The Secretary, acting through the 
        Director of the Centers for Disease Control and 
        Prevention, shall award grants to eligible State, 
        tribal, territorial, or local entities to strengthen 
        the response of State, tribal, territorial, or local 
        health care systems to domestic violence, dating 
        violence, sexual assault, and stalking.
            (2) Eligible entities.--To be eligible to receive a 
        grant under this section, an entity shall--
                    (A) be--
                            (i) a State department (or other 
                        division) of health, a State domestic 
                        or sexual assault coalition or service-
                        based program, State law enforcement 
                        task force, or any other nonprofit, 
                        nongovernmental, tribal, territorial, 
                        or State entity with a history of 
                        effective work in the fields of 
                        domestic violence, dating violence, 
                        sexual assault or stalking, and health 
                        care; or
                            (ii) a local, nonprofit domestic 
                        violence, dating violence, sexual 
                        assault, or stalking service-based 
                        program, a local department (or other 
                        division) of health, a local health 
                        clinic, hospital, or health system, or 
                        any other nonprofit, tribal, or local 
                        entity with a history of effective work 
                        in the field of domestic or sexual 
                        violence and health;
                    (B) prepare and submit to the Secretary an 
                application at such time, in such manner, and 
                containing such agreements, assurances, and 
                information as the Secretary determines to be 
                necessary to carry out the purposes for which 
                the grant is to be made; and
                    (C) demonstrate that the entity is 
                representing a team of organizations and 
                agencies working collaboratively to strengthen 
                the response of the health care system involved 
                to domestic violence, dating violence, sexual 
                assault, or stalking and that such team 
                includes domestic violence, dating violence, 
                sexual assault or stalking and health care 
                organizations.
            (3) Duration.--A program conducted under a grant 
        awarded under this section shall not exceed 2 years.
    (b) Use of Funds.--
            (1) In general.--An entity shall use amounts 
        received under a grant under this section to design and 
        implement comprehensive strategies to improve the 
        response of the health care system involved to domestic 
        or sexual violence in clinical and public health 
        settings, hospitals, clinics, managed care settings 
        (including behavioral and mental health), and other 
        health settings.
            (2) Mandatory strategies.--Strategies implemented 
        under paragraph (1) shall include the following:
                    (A) The implementation, dissemination, and 
                evaluation of policies and procedures to guide 
                health care professionals and behavioral and 
                public health staff in responding to domestic 
                violence, dating violence, sexual assault, and 
                stalking, including strategies to ensure that 
                health information is maintained in a manner 
                that protects the patient's privacy and safety 
                and prohibits insurance discrimination.
                    (B) The development of on-site access to 
                services to address the safety, medical, mental 
                health, and economic needs of patients either 
                by increasing the capacity of existing health 
                care professionals and behavioral and public 
                health staff to address domestic violence, 
                dating violence, sexual assault, and stalking, 
                by contracting with or hiring domestic or 
                sexual assault advocates to provide the 
                services, or to model other services 
                appropriate to the geographic and cultural 
                needs of a site.
                    (C) The evaluation of practice and the 
                institutionalization of identification, 
                intervention, and documentation including 
                quality improvement measurements.
                    (D) The provision of training and followup 
                technical assistance to health care 
                professionals, behavioral and public health 
                staff, and allied health professionals to 
                identify, assess, treat, and refer clients who 
                are victims of domestic violence, dating 
                violence, sexual violence, or stalking.
            (3) Permissive strategies.--Strategies implemented 
        under paragraph (1) may include the following:
                    (A) Where appropriate, the development of 
                training modules and policies that address the 
                overlap of child abuse, domestic violence, 
                dating violence, sexual assault, and stalking 
                and elder abuse as well as childhood exposure 
                to domestic violence.
                    (B) The creation, adaptation, and 
                implementation of public education campaigns 
                for patients concerning domestic violence, 
                dating violence, sexual assault, and stalking 
                prevention.
                    (C) The development, adaptation, and 
                dissemination of domestic violence, dating 
                violence, sexual assault, and stalking 
                education materials to patients and health care 
                professionals and behavioral and public health 
                staff.
                    (D) The promotion of the inclusion of 
                domestic violence, dating violence, sexual 
                assault, and stalking into health professional 
                training schools, including medical, dental, 
                nursing school, social work, and mental health 
                curriculum.
                    (E) The integration of domestic violence, 
                dating violence, sexual assault, and stalking 
                into health care accreditation and professional 
                licensing examinations, such as medical, 
                dental, social work, and nursing boards.
    (c) Allocation of Funds.--Funds appropriated under this 
section shall be distributed equally between State and local 
programs.
    (d) Authorization of Appropriations.--There is authorized 
to be appropriated to award grants under this section, 
$5,000,000 for each of fiscal years 2007 through 2011.

SEC. 399Q. [280G-4] PUBLIC AND HEALTH CARE PROVIDER EDUCATION AND 
                    SUPPORT SERVICES.

    (a) In General.--The Secretary, directly or through the 
awarding of grants to public or private nonprofit entities, may 
conduct demonstration projects for the purpose of improving the 
provision of information on prematurity to health professionals 
and other health care providers and the public and improving 
the treatment and outcomes for babies born preterm.
    (b) Activities.--Activities to be carried out under the 
demonstration project under subsection (a) may include the 
establishment of--
            (1) programs to test and evaluate various 
        strategies to provide information and education to 
        health professionals, other health care providers, and 
        the public concerning--
                    (A) the signs of preterm labor, updated as 
                new research results become available;
                    (B) the screening for and the treating of 
                infections;
                    (c) counseling on optimal weight and good 
                nutrition, including folic acid;
                    (D) smoking cessation education and 
                counseling;
                    (E) stress management; and
                    (F) appropriate prenatal care;
            (2) programs to improve the treatment and outcomes 
        for babies born premature, including the use of 
        evidence-based standards of care by health care 
        professionals for pregnant women at risk of preterm 
        labor or other serious complications and for infants 
        born preterm and at a low birthweight;
            (3) programs to respond to the informational needs 
        of families during the stay of an infant in a neonatal 
        intensive care unit, during the transition of the 
        infant to the home, and in the event of a newborn 
        death; and
            (4) such other programs as the Secretary determines 
        appropriate to achieve the purpose specified in 
        subsection (a).
    (c) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section $5,000,000 for 
each of fiscal years 2007 through 2011.

SEC. 399R. [280G-6] CHRONIC KIDNEY DISEASE INITIATIVES.

    (a) In General.--The Secretary shall establish pilot 
projects to--
            (1) increase public and medical community awareness 
        (particularly of those who treat patients with diabetes 
        and hypertension) regarding chronic kidney disease, 
        focusing on prevention;
            (2) increase screening for chronic kidney disease, 
        focusing on Medicare beneficiaries at risk of chronic 
        kidney disease; and
            (3) enhance surveillance systems to better assess 
        the prevalence and incidence of chronic kidney disease.
    (b) Scope and Duration.--
            (1) Scope.--The Secretary shall select at least 3 
        States in which to conduct pilot projects under this 
        section.
            (2) Duration.--The pilot projects under this 
        section shall be conducted for a period that is not 
        longer than 5 years and shall begin on January 1, 2009.
    (c) Evaluation and Report.--The Comptroller General of the 
United States shall conduct an evaluation of the pilot projects 
conducted under this section. Not later than 12 months after 
the date on which the pilot projects are completed, the 
Comptroller General shall submit to Congress a report on the 
evaluation.
    (d) Authorization of Appropriations.--There are authorized 
to be appropriated such sums as may be necessary for the 
purpose of carrying out this section.

SEC. 399S.[280G-7] AMYOTROPHIC LATERAL SCLEROSIS REGISTRY.

    (a) Establishment.--
            (1) In general.--Not later than 1 year after the 
        receipt of the report described in subsection 
        (b)(2)(A), the Secretary, acting through the Director 
        of the Centers for Disease Control and Prevention, may, 
        if scientifically advisable--
                    (A) develop a system to collect data on 
                amyotrophic lateral sclerosis (referred to in 
                this section as ``ALS'') and other motor neuron 
                disorders that can be confused with ALS, 
                misdiagnosed as ALS, and in some cases progress 
                to ALS, including information with respect to 
                the incidence and prevalence of the disease in 
                the United States; and
                    (B) establish a national registry for the 
                collection and storage of such data to develop 
                a population-based registry of cases in the 
                United States of ALS and other motor neuron 
                disorders that can be confused with ALS, 
                misdiagnosed as ALS, and in some cases progress 
                to ALS.
            (2) Purpose.--It is the purpose of the registry 
        established under paragraph (1)(B) to--
                    (A) better describe the incidence and 
                prevalence of ALS in the United States;
                    (B) examine appropriate factors, such as 
                environmental and occupational, that may be 
                associated with the disease;
                    (C) better outline key demographic factors 
                (such as age, race or ethnicity, gender, and 
                family history of individuals who are diagnosed 
                with the disease) associated with the disease;
                    (D) better examine the connection between 
                ALS and other motor neuron disorders that can 
                be confused with ALS, misdiagnosed as ALS, and 
                in some cases progress to ALS; and
                    (E) other matters as recommended by the 
                Advisory Committee established under subsection 
                (b).
    (b) Advisory Committee.--
            (1) Establishment.--Not later than 180 days after 
        the date of the enactment of this section, the 
        Secretary, acting through the Director of the Centers 
        for Disease Control and Prevention, may establish a 
        committee to be known as the Advisory Committee on the 
        National ALS Registry (referred to in this section as 
        the ``Advisory Committee''). The Advisory Committee 
        shall be composed of not more than 27 members to be 
        appointed by the Secretary, acting through the Centers 
        for Disease Control and Prevention, of which--
                    (A) two-thirds of such members shall 
                represent governmental agencies--
                            (i) including at least one member 
                        representing--
                                    (I) the National Institutes 
                                of Health, to include, upon the 
                                recommendation of the Director 
                                of the National Institutes of 
                                Health, representatives from 
                                the National Institute of 
                                Neurological Disorders and 
                                Stroke and the National 
                                Institute of Environmental 
                                Health Sciences;
                                    (II) the Department of 
                                Veterans Affairs;
                                    (III) the Agency for Toxic 
                                Substances and Disease 
                                Registry; and
                                    (IV) the Centers for 
                                Disease Control and Prevention; 
                                and
                            (ii) of which at least one such 
                        member shall be a clinician with 
                        expertise on ALS and related diseases, 
                        an epidemiologist with experience in 
                        data registries, a statistician, an 
                        ethicist, and a privacy expert 
                        (relating to the privacy regulations 
                        under the Health Insurance Portability 
                        and Accountability Act of 1996); and
                    (B) one-third of such members shall be 
                public members, including at least one member 
                representing--
                            (i) national and voluntary health 
                        associations;
                            (ii) patients with ALS or their 
                        family members;
                            (iii) clinicians with expertise on 
                        ALS and related diseases;
                            (iv) epidemiologists with 
                        experience in data registries;
                            (v) geneticists or experts in 
                        genetics who have experience with the 
                        genetics of ALS or other neurological 
                        diseases and
                            (vi) other individuals with an 
                        interest in developing and maintaining 
                        the National ALS Registry.
            (2) Duties.--The Advisory Committee may review 
        information and make recommendations to the Secretary 
        concerning--
                    (A) the development and maintenance of the 
                National ALS Registry;
                    (B) the type of information to be collected 
                and stored in the Registry;
                    (C) the manner in which such data is to be 
                collected;
                    (D) the use and availability of such data 
                including guidelines for such use; and
                    (E) the collection of information about 
                diseases and disorders that primarily affect 
                motor neurons that are considered essential to 
                furthering the study and cure of ALS.
            (3) Report.--Not later than 270 days after the date 
        on which the Advisory Committee is established, the 
        Advisory Committee may submit a report to the Secretary 
        concerning the review conducted under paragraph (2) 
        that contains the recommendations of the Advisory 
        Committee with respect to the results of such review.
    (c) Grants.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, may award 
grants to, and enter into contracts and cooperative agreements 
with, public or private nonprofit entities for the collection, 
analysis, and reporting of data on ALS and other motor neuron 
disorders that can be confused with ALS, misdiagnosed as ALS, 
and in some cases progress to ALS after receiving the report 
under subsection (b)(3).
    (d) Coordination With State, Local, and Federal 
Registries.--
            (1) \1\ In general.--In establishing the National 
        ALS Registry under subsection (a), the Secretary, 
        acting through the Director of the Centers for Disease 
        Control and Prevention, may--
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    \1\ So in law. Subsection (d) (as added by section 2 of Public Law 
110-373) does not include a paragraph (2).
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                    (A) identify, build upon, expand, and 
                coordinate among existing data and surveillance 
                systems, surveys, registries, and other Federal 
                public health and environmental infrastructure 
                wherever possible, which may include--
                            (i) any registry pilot projects 
                        previously supported by the Centers for 
                        Disease Control and Prevention;
                            (ii) the Department of Veterans 
                        Affairs ALS Registry;
                            (iii) the DNA and Cell Line 
                        Repository of the National Institute of 
                        Neurological Disorders and Stroke Human 
                        Genetics Resource Center at the 
                        National Institutes of Health;
                            (iv) Agency for Toxic Substances 
                        and Disease Registry studies, including 
                        studies conducted in Illinois, 
                        Missouri, El Paso and San Antonio, 
                        Texas, and Massachusetts;
                            (v) State-based ALS registries;
                            (vi) the National Vital Statistics 
                        System; and
                            (vii) any other existing or 
                        relevant databases that collect or 
                        maintain information on those motor 
                        neuron diseases recommended by the 
                        Advisory Committee established in 
                        subsection (b); and
                    (B) provide for research access to ALS data 
                as recommended by the Advisory Committee 
                established in subsection (b) to the extent 
                permitted by applicable statutes and 
                regulations and in a manner that protects 
                personal privacy consistent with applicable 
                privacy statutes and regulations.
                    (C) Coordination with nih and department of 
                veterans affairs.--Consistent with applicable 
                privacy statutes and regulations, the Secretary 
                may ensure that epidemiological and other types 
                of information obtained under subsection (a) is 
                made available to the National Institutes of 
                Health and the Department of Veterans Affairs.
    (e) Definition.--For the purposes of this section, the term 
``national voluntary health association'' means a national non-
profit organization with chapters or other affiliated 
organizations in States throughout the United States with 
experience serving the population of individuals with ALS and 
have demonstrated experience in ALS research, care, and patient 
services.

SEC. 399T. [280G-8] SUPPORT FOR PATIENTS RECEIVING A POSITIVE DIAGNOSIS 
                    OF DOWN SYNDROME OR OTHER PRENATALLY OR POSTNATALLY 
                    DIAGNOSED CONDITIONS.

    (a) Definitions.--In this section:
            (1) Down syndrome.--The term ``Down syndrome'' 
        refers to a chromosomal disorder caused by an error in 
        cell division that results in the presence of an extra 
        whole or partial copy of chromosome 21.
            (2) Health care provider.--The term ``health care 
        provider'' means any person or entity required by State 
        or Federal law or regulation to be licensed, 
        registered, or certified to provide health care 
        services, and who is so licensed, registered, or 
        certified.
            (3) Postnatally diagnosed condition.--The term 
        ``postnatally diagnosed condition'' means any health 
        condition identified during the 12-month period 
        beginning at birth.
            (4) Prenatally diagnosed condition.--The term 
        ``prenatally diagnosed condition'' means any fetal 
        health condition identified by prenatal genetic testing 
        or prenatal screening procedures.
            (5) Prenatal test.--The term ``prenatal test'' 
        means diagnostic or screening tests offered to pregnant 
        women seeking routine prenatal care that are 
        administered on a required or recommended basis by a 
        health care provider based on medical history, family 
        background, ethnic background, previous test results, 
        or other risk factors.
    (b) Information and Support Services.--
            (1) In general.--The Secretary, acting through the 
        Director of the National Institutes of Health, the 
        Director of the Centers for Disease Control and 
        Prevention, or the Administrator of the Health 
        Resources and Services Administration, may authorize 
        and oversee certain activities, including the awarding 
        of grants, contracts or cooperative agreements to 
        eligible entities, to--
                    (A) collect, synthesize, and disseminate 
                current evidence-based information relating to 
                Down syndrome or other prenatally or 
                postnatally diagnosed conditions; and
                    (B) coordinate the provision of, and access 
                to, new or existing supportive services for 
                patients receiving a positive diagnosis for 
                Down syndrome or other prenatally or 
                postnatally diagnosed conditions, including--
                            (i) the establishment of a resource 
                        telephone hotline accessible to 
                        patients receiving a positive test 
                        result or to the parents of newly 
                        diagnosed infants with Down syndrome 
                        and other diagnosed conditions;
                            (ii) the expansion and further 
                        development of the National 
                        Dissemination Center for Children with 
                        Disabilities, so that such Center can 
                        more effectively conduct outreach to 
                        new and expecting parents and provide 
                        them with up-to-date information on the 
                        range of outcomes for individuals 
                        living with the diagnosed condition, 
                        including physical, developmental, 
                        educational, and psychosocial outcomes;
                            (iii) the expansion and further 
                        development of national and local peer-
                        support programs, so that such programs 
                        can more effectively serve women who 
                        receive a positive diagnosis for Down 
                        syndrome or other prenatal conditions 
                        or parents of infants with a 
                        postnatally diagnosed condition;
                            (iv) the establishment of a 
                        national registry, or network of local 
                        registries, of families willing to 
                        adopt newborns with Down syndrome or 
                        other prenatally or postnatally 
                        diagnosed conditions, and links to 
                        adoption agencies willing to place 
                        babies with Down syndrome or other 
                        prenatally or postnatally diagnosed 
                        conditions, with families willing to 
                        adopt; and
                            (v) the establishment of awareness 
                        and education programs for health care 
                        providers who provide, interpret, or 
                        inform parents of the results of 
                        prenatal tests for Down syndrome or 
                        other prenatally or postnatally 
                        diagnosed conditions, to patients, 
                        consistent with the purpose described 
                        in section 2(b)(1) \1\ of the 
                        Prenatally and Postnatally Diagnosed 
                        Conditions Awareness Act.
---------------------------------------------------------------------------
    \1\ So in law. Probably should read ``section 2(1)''.
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            (2) Eligible entity.--In this subsection, the term 
        ``eligible entity'' means--
                    (A) a State or a political subdivision of a 
                State;
                    (B) a consortium of 2 or more States or 
                political subdivisions of States;
                    (C) a territory;
                    (D) a health facility or program operated 
                by or pursuant to a contract with or grant from 
                the Indian Health Service; or
                    (E) any other entity with appropriate 
                expertise in prenatally and postnatally 
                diagnosed conditions (including nationally 
                recognized disability groups), as determined by 
                the Secretary.
            (3) Distribution.--In distributing funds under this 
        subsection, the Secretary shall place an emphasis on 
        funding partnerships between health care professional 
        groups and disability advocacy organizations.
    (c) Provision of Information to Providers.--
            (1) In general.--A grantee under this section shall 
        make available to health care providers of parents who 
        receive a prenatal or postnatal diagnosis the 
        following:
                    (A) Up-to-date, evidence-based, written 
                information concerning the range of outcomes 
                for individuals living with the diagnosed 
                condition, including physical, developmental, 
                educational, and psychosocial outcomes.
                    (B) Contact information regarding support 
                services, including information hotlines 
                specific to Down syndrome or other prenatally 
                or postnatally diagnosed conditions, resource 
                centers or clearinghouses, national and local 
                peer support groups, and other education and 
                support programs as described in subsection 
                (b)(2).
            (2) Informational requirements.--Information 
        provided under this subsection shall be--
                    (A) culturally and linguistically 
                appropriate as needed by women receiving a 
                positive prenatal diagnosis or the family of 
                infants receiving a postnatal diagnosis; and
                    (B) approved by the Secretary.
    (d) Report.--Not later than 2 years after the date of 
enactment of this section, the Government Accountability Office 
shall submit a report to Congress concerning the effectiveness 
of current healthcare and family support programs serving as 
resources for the families of children with disabilities.

SEC. 399U. [280G-10] COMMUNITY PREVENTIVE SERVICES TASK FORCE.

    (a) Establishment and Purpose.--The Director of the Centers 
for Disease Control and Prevention shall convene an independent 
Community Preventive Services Task Force (referred to in this 
subsection as the ``Task Force'') to be composed of individuals 
with appropriate expertise. Such Task Force shall review the 
scientific evidence related to the effectiveness, 
appropriateness, and cost-effectiveness of community preventive 
interventions for the purpose of developing recommendations, to 
be published in the Guide to Community Preventive Services 
(referred to in this section as the ``Guide''), for individuals 
and organizations delivering population-based services, 
including primary care professionals, health care systems, 
professional societies, employers, community organizations, 
non-profit organizations, schools, governmental public health 
agencies, Indian tribes, tribal organizations and urban Indian 
organizations, medical groups, Congress and other policy-
makers. Community preventive services include any policies, 
programs, processes or activities designed to affect or 
otherwise affecting health at the population level.
    (b) Duties.--The duties of the Task Force shall include--
            (1) the development of additional topic areas for 
        new recommendations and interventions related to those 
        topic areas, including those related to specific 
        populations and age groups, as well as the social, 
        economic and physical environments that can have broad 
        effects on the health and disease of populations and 
        health disparities among sub-populations and age 
        groups;
            (2) at least once during every 5-year period, 
        review interventions and update recommendations related 
        to existing topic areas, including new or improved 
        techniques to assess the health effects of 
        interventions, including health impact assessment and 
        population health modeling;
            (3) improved integration with Federal Government 
        health objectives and related target setting for health 
        improvement;
            (4) the enhanced dissemination of recommendations;
            (5) the provision of technical assistance to those 
        health care professionals, agencies, and organizations 
        that request help in implementing the Guide 
        recommendations; and
            (6) providing yearly reports to Congress and 
        related agencies identifying gaps in research and 
        recommending priority areas that deserve further 
        examination, including areas related to populations and 
        age groups not adequately addressed by current 
        recommendations.
    (c) Role of Agency.--The Director shall provide ongoing 
administrative, research, and technical support for the 
operations of the Task Force, including coordinating and 
supporting the dissemination of the recommendations of the Task 
Force, ensuring adequate staff resources, and assistance to 
those organizations requesting it for implementation of Guide 
recommendations.
    (d) Coordination With Preventive Services Task Force.--The 
Task Force shall take appropriate steps to coordinate its work 
with the U.S. Preventive Services Task Force and the Advisory 
Committee on Immunization Practices, including the examination 
of how each task force's recommendations interact at the nexus 
of clinic and community.
    (e) Operation.--In carrying out the duties under subsection 
(b), the Task Force shall not be subject to the provisions of 
Appendix 2 of title 5, United States Code.
    (f) Authorization of Appropriations.--There are authorized 
to be appropriated such sums as may be necessary for each 
fiscal year to carry out the activities of the Task Force.

SEC. 399V. [280G-11]GRANTS TO PROMOTE POSITIVE HEALTH BEHAVIORS AND 
                    OUTCOMES.

    (a) Grants Authorized.--The Director of the Centers for 
Disease Control and Prevention, in collaboration with the 
Secretary, shall award grants to eligible entities to promote 
positive health behaviors and outcomes for populations in 
medically underserved communities through the use of community 
health workers.
    (b) Use of Funds.--Grants awarded under subsection (a) 
shall be used to support community health workers--
            (1) to educate, guide, and provide outreach in a 
        community setting regarding health problems prevalent 
        in medically underserved communities, particularly 
        racial and ethnic minority populations;
            (2) to educate and provide guidance regarding 
        effective strategies to promote positive health 
        behaviors and discourage risky health behaviors;
            (3) to educate and provide outreach regarding 
        enrollment in health insurance including the Children's 
        Health Insurance Program under title XXI of the Social 
        Security Act, Medicare under title XVIII of such Act 
        and Medicaid under title XIX of such Act;
            (4) to identify and refer underserved populations 
        to appropriate healthcare agencies and community-based 
        programs and organizations in order to increase access 
        to quality healthcare services and to eliminate 
        duplicative care; or
            (5) to educate, guide, and provide home visitation 
        services regarding maternal health and prenatal care.
    (c) Application.--Each eligible entity that desires to 
receive a grant under subsection (a) shall submit an 
application to the Secretary, at such time, in such manner, and 
accompanied by such information as the Secretary may require.
    (d) Priority.--In awarding grants under subsection (a), the 
Secretary shall give priority to applicants that--
            (1) propose to target geographic areas--
                    (A) with a high percentage of residents who 
                are eligible for health insurance but are 
                uninsured or underinsured;
                    (B) with a high percentage of residents who 
                suffer from chronic diseases; or
                    (C) with a high infant mortality rate;
            (2) have experience in providing health or health-
        related social services to individuals who are 
        underserved with respect to such services; and
            (3) have documented community activity and 
        experience with community health workers.
    (e) Collaboration With Academic Institutions and the One-
stop Delivery System.--The Secretary shall encourage community 
health worker programs receiving funds under this section to 
collaborate with academic institutions and one-stop delivery 
systems under section 134(c) of the Workforce Investment Act of 
1998. Nothing in this section shall be construed to require 
such collaboration.
    (f) Evidence-based Interventions.--The Secretary shall 
encourage community health worker programs receiving funding 
under this section to implement a process or an outcome-based 
payment system that rewards community health workers for 
connecting underserved populations with the most appropriate 
services at the most appropriate time. Nothing in this section 
shall be construed to require such a payment.
    (g) Quality Assurance and Cost Effectiveness.--The 
Secretary shall establish guidelines for assuring the quality 
of the training and supervision of community health workers 
under the programs funded under this section and for assuring 
the cost-effectiveness of such programs.
    (h) Monitoring.--The Secretary shall monitor community 
health worker programs identified in approved applications 
under this section and shall determine whether such programs 
are in compliance with the guidelines established under 
subsection (g).
    (i) Technical Assistance.--The Secretary may provide 
technical assistance to community health worker programs 
identified in approved applications under this section with 
respect to planning, developing, and operating programs under 
the grant.
    (j) Authorization of Appropriations.--There are authorized 
to be appropriated, such sums as may be necessary to carry out 
this section for each of fiscal years 2010 through 2014.
    (k) Definitions.--In this section:
            (1) Community health worker.--The term ``community 
        health worker'' means an individual who promotes health 
        or nutrition within the community in which the 
        individual resides--
                    (A) by serving as a liaison between 
                communities and healthcare agencies;
                    (B) by providing guidance and social 
                assistance to community residents;
                    (C) by enhancing community residents' 
                ability to effectively communicate with 
                healthcare providers;
                    (D) by providing culturally and 
                linguistically appropriate health or nutrition 
                education;
                    (E) by advocating for individual and 
                community health;
                    (F) by providing referral and follow-up 
                services or otherwise coordinating care; and
                    (G) by proactively identifying and 
                enrolling eligible individuals in Federal, 
                State, local, private or nonprofit health and 
                human services programs.
            (2) Community setting.--The term ``community 
        setting'' means a home or a community organization 
        located in the neighborhood in which a participant in 
        the program under this section resides.
            (3) Eligible entity.--The term ``eligible entity'' 
        means a public or nonprofit private entity (including a 
        State or public subdivision of a State, a public health 
        department, a free health clinic, a hospital, or a 
        Federally-qualified health center (as defined in 
        section 1861(aa) of the Social Security Act)), or a 
        consortium of any such entities.
            (4) Medically underserved community.--The term 
        ``medically underserved community'' means a community 
        identified by a State--
                    (A) that has a substantial number of 
                individuals who are members of a medically 
                underserved population, as defined by section 
                330(b)(3); and
                    (B) a significant portion of which is a 
                health professional shortage area as designated 
                under section 332.

SEC. 399V-1. [280G-12] PRIMARY CARE EXTENSION PROGRAM.

    (a) Establishment, Purpose and Definition.--
            (1) In general.--The Secretary, acting through the 
        Director of the Agency for Healthcare Research and 
        Quality, shall establish a Primary Care Extension 
        Program.
            (2) Purpose.--The Primary Care Extension Program 
        shall provide support and assistance to primary care 
        providers to educate providers about preventive 
        medicine, health promotion, chronic disease management, 
        mental and behavioral health services (including 
        substance abuse prevention and treatment services), and 
        evidence-based and evidence-informed therapies and 
        techniques, in order to enable providers to incorporate 
        such matters into their practice and to improve 
        community health by working with community-based health 
        connectors (referred to in this section as ``Health 
        Extension Agents'').
            (3) Definitions.--In this section:
                    (A) Health extension agent.--The term 
                ``Health Extension Agent'' means any local, 
                community-based health worker who facilitates 
                and provides assistance to primary care 
                practices by implementing quality improvement 
                or system redesign, incorporating the 
                principles of the patient-centered medical home 
                to provide high-quality, effective, efficient, 
                and safe primary care and to provide guidance 
                to patients in culturally and linguistically 
                appropriate ways, and linking practices to 
                diverse health system resources.
                    (B) Primary care provider.--The term 
                ``primary care provider'' means a clinician who 
                provides integrated, accessible health care 
                services and who is accountable for addressing 
                a large majority of personal health care needs, 
                including providing preventive and health 
                promotion services for men, women, and children 
                of all ages, developing a sustained partnership 
                with patients, and practicing in the context of 
                family and community, as recognized by a State 
                licensing or regulatory authority, unless 
                otherwise specified in this section.
    (b) Grants To Establish State Hubs and Local Primary Care 
Extension Agencies.--
            (1) Grants.--The Secretary shall award competitive 
        grants to States for the establishment of State- or 
        multistate-level primary care Primary Care Extension 
        Program State Hubs (referred to in this section as 
        ``Hubs'').
            (2) Composition of hubs.--A Hub established by a 
        State pursuant to paragraph (1)--
                    (A) shall consist of, at a minimum, the 
                State health department, the entity responsible 
                for administering the State Medicaid program 
                (if other than the State health department), 
                the State-level entity administering the 
                Medicare program, and the departments that 
                train providers in primary care in 1 or more 
                health professions schools in the State; and
                    (B) may include entities such as hospital 
                associations, primary care practice-based 
                research networks, health professional 
                societies, State primary care associations, 
                State licensing boards, organizations with a 
                contract with the Secretary under section 1153 
                of the Social Security Act, consumer groups, 
                and other appropriate entities.
    (c) State and Local Activities.--
            (1) Hub activities.--Hubs established under a grant 
        under subsection (b) shall--
                    (A) submit to the Secretary a plan to 
                coordinate functions with quality improvement 
                organizations and area health education centers 
                if such entities are members of the Hub not 
                described in subsection (b)(2)(A);
                    (B) contract with a county- or local-level 
                entity that shall serve as the Primary Care 
                Extension Agency to administer the services 
                described in paragraph (2);
                    (C) organize and administer grant funds to 
                county- or local-level Primary Care Extension 
                Agencies that serve a catchment area, as 
                determined by the State; and
                    (D) organize State-wide or multistate 
                networks of local-level Primary Care Extension 
                Agencies to share and disseminate information 
                and practices.
            (2) Local primary care extension agency 
        activities.--
                    (A) Required activities.--Primary Care 
                Extension Agencies established by a Hub under 
                paragraph (1) shall--
                            (i) assist primary care providers 
                        to implement a patient-centered medical 
                        home to improve the accessibility, 
                        quality, and efficiency of primary care 
                        services, including health homes;
                            (ii) develop and support primary 
                        care learning communities to enhance 
                        the dissemination of research findings 
                        for evidence-based practice, assess 
                        implementation of practice improvement, 
                        share best practices, and involve 
                        community clinicians in the generation 
                        of new knowledge and identification of 
                        important questions for research;
                            (iii) participate in a national 
                        network of Primary Care Extension Hubs 
                        and propose how the Primary Care 
                        Extension Agency will share and 
                        disseminate lessons learned and best 
                        practices; and
                            (iv) develop a plan for financial 
                        sustainability involving State, local, 
                        and private contributions, to provide 
                        for the reduction in Federal funds that 
                        is expected after an initial 6-year 
                        period of program establishment, 
                        infrastructure development, and 
                        planning.
                    (B) Discretionary activities.--Primary Care 
                Extension Agencies established by a Hub under 
                paragraph (1) may--
                            (i) provide technical assistance, 
                        training, and organizational support 
                        for community health teams established 
                        under section 3602 of the Patient 
                        Protection and Affordable Care Act;
                            (ii) collect data and provision of 
                        primary care provider feedback from 
                        standardized measurements of processes 
                        and outcomes to aid in continuous 
                        performance improvement;
                            (iii) collaborate with local health 
                        departments, community health centers, 
                        tribes and tribal entities, and other 
                        community agencies to identify 
                        community health priorities and local 
                        health workforce needs, and participate 
                        in community-based efforts to address 
                        the social and primary determinants of 
                        health, strengthen the local primary 
                        care workforce, and eliminate health 
                        disparities;
                            (iv) develop measures to monitor 
                        the impact of the proposed program on 
                        the health of practice enrollees and of 
                        the wider community served; and
                            (v) participate in other 
                        activities, as determined appropriate 
                        by the Secretary.
    (d) Federal Program Administration.--
            (1) Grants; types.--Grants awarded under subsection 
        (b) shall be--
                    (A) program grants, that are awarded to 
                State or multistate entities that submit fully-
                developed plans for the implementation of a 
                Hub, for a period of 6 years; or
                    (B) planning grants, that are awarded to 
                State or multistate entities with the goal of 
                developing a plan for a Hub, for a period of 2 
                years.
            (2) Applications.--To be eligible for a grant under 
        subsection (b), a State or multistate entity shall 
        submit to the Secretary an application, at such time, 
        in such manner, and containing such information as the 
        Secretary may require.
            (3) Evaluation.--A State that receives a grant 
        under subsection (b) shall be evaluated at the end of 
        the grant period by an evaluation panel appointed by 
        the Secretary.
            (4) Continuing support.--After the sixth year in 
        which assistance is provided to a State under a grant 
        awarded under subsection (b), the State may receive 
        additional support under this section if the State 
        program has received satisfactory evaluations with 
        respect to program performance and the merits of the 
        State sustainability plan, as determined by the 
        Secretary.
            (5) Limitation.--A State shall not use in excess of 
        10 percent of the amount received under a grant to 
        carry out administrative activities under this section. 
        Funds awarded pursuant to this section shall not be 
        used for funding direct patient care.
    (e) Requirements on the Secretary.--In carrying out this 
section, the Secretary shall consult with the heads of other 
Federal agencies with demonstrated experience and expertise in 
health care and preventive medicine, such as the Centers for 
Disease Control and Prevention, the Substance Abuse and Mental 
Health Administration, the Health Resources and Services 
Administration, the National Institutes of Health, the Office 
of the National Coordinator for Health Information Technology, 
the Indian Health Service, the Agricultural Cooperative 
Extension Service of the Department of Agriculture, and other 
entities, as the Secretary determines appropriate.
    (f) Authorization of Appropriations.--To awards grants as 
provided in subsection (d), there are authorized to be 
appropriated $120,000,000 for each of fiscal years 2011 and 
2012, and such sums as may be necessary to carry out this 
section for each of fiscal years 2013 through 2014.

SEC. 399V-2. [280G-13] NATIONAL CONGENITAL HEART DISEASE SURVEILLANCE 
                    SYSTEM.

    (a) In General.--The Secretary, acting through the Director 
of the Centers for Disease Control and Prevention, may--
            (1) enhance and expand infrastructure to track the 
        epidemiology of congenital heart disease and to 
        organize such information into a nationally-
        representative, population-based surveillance system 
        that compiles data concerning actual occurrences of 
        congenital heart disease, to be known as the `National 
        Congenital Heart Disease Surveillance System'; or
            (2) award a grant to one eligible entity to 
        undertake the activities described in paragraph (1).
    (b) Purpose.--The purpose of the Congenital Heart Disease 
Surveillance System shall be to facilitate further research 
into the types of health services patients use and to identify 
possible areas for educational outreach and prevention in 
accordance with standard practices of the Centers for Disease 
Control and Prevention.
    (c) Content.--The Congenital Heart Disease Surveillance 
System--
            (1) may include information concerning the 
        incidence and prevalence of congenital heart disease in 
        the United States;
            (2) may be used to collect and store data on 
        congenital heart disease, including data concerning--
                    (A) demographic factors associated with 
                congenital heart disease, such as age, race, 
                ethnicity, sex, and family history of 
                individuals who are diagnosed with the disease;
                    (B) risk factors associated with the 
                disease;
                    (C) causation of the disease;
                    (D) treatment approaches; and
                    (E) outcome measures, such that analysis of 
                the outcome measures will allow derivation of 
                evidence-based best practices and guidelines 
                for congenital heart disease patients; and
            (3) may ensure the collection and analysis of 
        longitudinal data related to individuals of all ages 
        with congenital heart disease, including infants, young 
        children, adolescents, and adults of all ages.
    (d) Public Access.--The Congenital Heart Disease 
Surveillance System shall be made available to the public, as 
appropriate, including congenital heart disease researchers.
    (e) Patient Privacy.--The Secretary shall ensure that the 
Congenital Heart Disease Surveillance System is maintained in a 
manner that complies with the regulations promulgated under 
section 264 of the Health Insurance Portability and 
Accountability Act of 1996.
    (f) Eligibility for Grant.--To be eligible to receive a 
grant under subsection (a)(2), an entity shall--
            (1) be a public or private nonprofit entity with 
        specialized experience in congenital heart disease; and
            (2) submit to the Secretary an application at such 
        time, in such manner, and containing such information 
        as the Secretary may require.

SEC. 399V-3. [280G-14] NATIONAL DIABETES PREVENTION PROGRAM.

    (a) In General.--The Secretary, acting through the Director 
of the Centers for Disease Control and Prevention, shall 
establish a national diabetes prevention program (referred to 
in this section as the ``program'') targeted at adults at high 
risk for diabetes in order to eliminate the preventable burden 
of diabetes.
    (b) Program Activities.--The program described in 
subsection (a) shall include--
            (1) a grant program for community-based diabetes 
        prevention program model sites;
            (2) a program within the Centers for Disease 
        Control and Prevention to determine eligibility of 
        entities to deliver community-based diabetes prevention 
        services;
            (3) a training and outreach program for lifestyle 
        intervention instructors; and
            (4) evaluation, monitoring and technical 
        assistance, and applied research carried out by the 
        Centers for Disease Control and Prevention.
    (c) Eligible Entities.--To be eligible for a grant under 
subsection (b)(1), an entity shall be a State or local health 
department, a tribal organization, a national network of 
community-based non-profits focused on health and wellbeing, an 
academic institution, or other entity, as the Secretary 
determines.
    (d) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of fiscal 
years 2010 through 2014.

SEC. 399V-4. [280G-15] STATE DEMONSTRATION PROGRAMS TO EVALUATE 
                    ALTERNATIVES TO CURRENT MEDICAL TORT LITIGATION.

    (a) In General.--The Secretary is authorized to award 
demonstration grants to States for the development, 
implementation, and evaluation of alternatives to current tort 
litigation for resolving disputes over injuries allegedly 
caused by health care providers or health care organizations. 
In awarding such grants, the Secretary shall ensure the 
diversity of the alternatives so funded.
    (b) Duration.--The Secretary may award grants under 
subsection (a) for a period not to exceed 5 years.
    (c) Conditions for Demonstration Grants.--
            (1) Requirements.--Each State desiring a grant 
        under subsection (a) shall develop an alternative to 
        current tort litigation that--
                    (A) allows for the resolution of disputes 
                over injuries allegedly caused by health care 
                providers or health care organizations; and
                    (B) promotes a reduction of health care 
                errors by encouraging the collection and 
                analysis of patient safety data related to 
                disputes resolved under subparagraph (A) by 
                organizations that engage in efforts to improve 
                patient safety and the quality of health care.
            (2) Alternative to current tort litigation.--Each 
        State desiring a grant under subsection (a) shall 
        demonstrate how the proposed alternative described in 
        paragraph (1)(A)--
                    (A) makes the medical liability system more 
                reliable by increasing the availability of 
                prompt and fair resolution of disputes;
                    (B) encourages the efficient resolution of 
                disputes;
                    (C) encourages the disclosure of health 
                care errors;
                    (D) enhances patient safety by detecting, 
                analyzing, and helping to reduce medical errors 
                and adverse events;
                    (E) improves access to liability insurance;
                    (F) fully informs patients about the 
                differences in the alternative and current tort 
                litigation;
                    (G) provides patients the ability to opt 
                out of or voluntarily withdraw from 
                participating in the alternative at any time 
                and to pursue other options, including 
                litigation, outside the alternative;
                    (H) would not conflict with State law at 
                the time of the application in a way that would 
                prohibit the adoption of an alternative to 
                current tort litigation; and
                    (I) would not limit or curtail a patient's 
                existing legal rights, ability to file a claim 
                in or access a State's legal system, or 
                otherwise abrogate a patient's ability to file 
                a medical malpractice claim.
            (3) Sources of compensation.--Each State desiring a 
        grant under subsection (a) shall identify the sources 
        from and methods by which compensation would be paid 
        for claims resolved under the proposed alternative to 
        current tort litigation, which may include public or 
        private funding sources, or a combination of such 
        sources. Funding methods shall to the extent 
        practicable provide financial incentives for activities 
        that improve patient safety.
            (4) Scope.--
                    (A) In general.--Each State desiring a 
                grant under subsection (a) shall establish a 
                scope of jurisdiction (such as Statewide, 
                designated geographic region, a designated area 
                of health care practice, or a designated group 
                of health care providers or health care 
                organizations) for the proposed alternative to 
                current tort litigation that is sufficient to 
                evaluate the effects of the alternative. No 
                scope of jurisdiction shall be established 
                under this paragraph that is based on a health 
                care payer or patient population.
                    (B) Notification of patients.--A State 
                shall demonstrate how patients would be 
                notified that they are receiving health care 
                services that fall within such scope, and the 
                process by which they may opt out of or 
                voluntarily withdraw from participating in the 
                alternative. The decision of the patient 
                whether to participate or continue 
                participating in the alternative process shall 
                be made at any time and shall not be limited in 
                any way.
            (5) Preference in awarding demonstration grants.--
        In awarding grants under subsection (a), the Secretary 
        shall give preference to States--
                    (A) that have developed the proposed 
                alternative through substantive consultation 
                with relevant stakeholders, including patient 
                advocates, health care providers and health 
                care organizations, attorneys with expertise in 
                representing patients and health care 
                providers, medical malpractice insurers, and 
                patient safety experts;
                    (B) that make proposals that are likely to 
                enhance patient safety by detecting, analyzing, 
                and helping to reduce medical errors and 
                adverse events; and
                    (C) that make proposals that are likely to 
                improve access to liability insurance.
    (d) Application.--
            (1) In general.--Each State desiring a grant under 
        subsection (a) shall submit to the Secretary an 
        application, at such time, in such manner, and 
        containing such information as the Secretary may 
        require.
            (2) Review panel.--
                    (A) In general.--In reviewing applications 
                under paragraph (1), the Secretary shall 
                consult with a review panel composed of 
                relevant experts appointed by the Comptroller 
                General.
                    (B) Composition.--
                            (i) Nominations.--The Comptroller 
                        General shall solicit nominations from 
                        the public for individuals to serve on 
                        the review panel.
                            (ii) Appointment.--The Comptroller 
                        General shall appoint, at least 9 but 
                        not more than 13, highly qualified and 
                        knowledgeable individuals to serve on 
                        the review panel and shall ensure that 
                        the following entities receive fair 
                        representation on such panel:
                                    (I) Patient advocates.
                                    (II) Health care providers 
                                and health care organizations.
                                    (III) Attorneys with 
                                expertise in representing 
                                patients and health care 
                                providers.
                                    (IV) Medical malpractice 
                                insurers.
                                    (V) State officials.
                                    (VI) Patient safety 
                                experts.
                    (C) Chairperson.--The Comptroller General, 
                or an individual within the Government 
                Accountability Office designated by the 
                Comptroller General, shall be the chairperson 
                of the review panel.
                    (D) Availability of information.--The 
                Comptroller General shall make available to the 
                review panel such information, personnel, and 
                administrative services and assistance as the 
                review panel may reasonably require to carry 
                out its duties.
                    (E) Information from agencies.--The review 
                panel may request directly from any department 
                or agency of the United States any information 
                that such panel considers necessary to carry 
                out its duties. To the extent consistent with 
                applicable laws and regulations, the head of 
                such department or agency shall furnish the 
                requested information to the review panel.
    (e) Reports.--
            (1) By state.--Each State receiving a grant under 
        subsection (a) shall submit to the Secretary an annual 
        report evaluating the effectiveness of activities 
        funded with grants awarded under such subsection. Such 
        report shall, at a minimum, include the impact of the 
        activities funded on patient safety and on the 
        availability and price of medical liability insurance.
            (2) By secretary.--The Secretary shall submit to 
        Congress an annual compendium of the reports submitted 
        under paragraph (1) and an analysis of the activities 
        funded under subsection (a) that examines any 
        differences that result from such activities in terms 
        of the quality of care, number and nature of medical 
        errors, medical resources used, length of time for 
        dispute resolution, and the availability and price of 
        liability insurance.
    (f) Technical Assistance.--
            (1) In general.--The Secretary shall provide 
        technical assistance to the States applying for or 
        awarded grants under subsection (a).
            (2) Requirements.--Technical assistance under 
        paragraph (1) shall include--
                    (A) guidance on non-economic damages, 
                including the consideration of individual facts 
                and circumstances in determining appropriate 
                payment, guidance on identifying avoidable 
                injuries, and guidance on disclosure to 
                patients of health care errors and adverse 
                events; and
                    (B) the development, in consultation with 
                States, of common definitions, formats, and 
                data collection infrastructure for States 
                receiving grants under this section to use in 
                reporting to facilitate aggregation and 
                analysis of data both within and between 
                States.
            (3) Use of common definitions, formats, and data 
        collection infrastructure.--States not receiving grants 
        under this section may also use the common definitions, 
        formats, and data collection infrastructure developed 
        under paragraph (2)(B).
    (g) Evaluation.--
            (1) In general.--The Secretary, in consultation 
        with the review panel established under subsection 
        (d)(2), shall enter into a contract with an appropriate 
        research organization to conduct an overall evaluation 
        of the effectiveness of grants awarded under subsection 
        (a) and to annually prepare and submit a report to 
        Congress. Such an evaluation shall begin not later than 
        18 months following the date of implementation of the 
        first program funded by a grant under subsection (a).
            (2) Contents.--The evaluation under paragraph (1) 
        shall include--
                    (A) an analysis of the effects of the 
                grants awarded under subsection (a) with regard 
                to the measures described in paragraph (3);
                    (B) for each State, an analysis of the 
                extent to which the alternative developed under 
                subsection (c)(1) is effective in meeting the 
                elements described in subsection (c)(2);
                    (C) a comparison among the States receiving 
                grants under subsection (a) of the 
                effectiveness of the various alternatives 
                developed by such States under subsection 
                (c)(1);
                    (D) a comparison, considering the measures 
                described in paragraph (3), of States receiving 
                grants approved under subsection (a) and 
                similar States not receiving such grants; and
                    (E) a comparison, with regard to the 
                measures described in paragraph (3), of--
                            (i) States receiving grants under 
                        subsection (a);
                            (ii) States that enacted, prior to 
                        the date of enactment of the Patient 
                        Protection and Affordable Care Act, any 
                        cap on non-economic damages; and
                            (iii) States that have enacted, 
                        prior to the date of enactment of the 
                        Patient Protection and Affordable Care 
                        Act, a requirement that the complainant 
                        obtain an opinion regarding the merit 
                        of the claim, although the substance of 
                        such opinion may have no bearing on 
                        whether the complainant may proceed 
                        with a case.
            (3) Measures.--The evaluations under paragraph (2) 
        shall analyze and make comparisons on the basis of--
                    (A) the nature and number of disputes over 
                injuries allegedly caused by health care 
                providers or health care organizations;
                    (B) the nature and number of claims in 
                which tort litigation was pursued despite the 
                existence of an alternative under subsection 
                (a);
                    (C) the disposition of disputes and claims, 
                including the length of time and estimated 
                costs to all parties;
                    (D) the medical liability environment;
                    (E) health care quality;
                    (F) patient safety in terms of detecting, 
                analyzing, and helping to reduce medical errors 
                and adverse events;
                    (G) patient and health care provider and 
                organization satisfaction with the alternative 
                under subsection (a) and with the medical 
                liability environment; and
                    (H) impact on utilization of medical 
                services, appropriately adjusted for risk.
            (4) Funding.--The Secretary shall reserve 5 percent 
        of the amount appropriated in each fiscal year under 
        subsection (k) to carry out this subsection.
    (h) MedPAC and MACPAC Reports.--
            (1) MedPAC.--The Medicare Payment Advisory 
        Commission shall conduct an independent review of the 
        alternatives to current tort litigation that are 
        implemented under grants under subsection (a) to 
        determine the impact of such alternatives on the 
        Medicare program under title XVIII of the Social 
        Security Act, and its beneficiaries.
            (2) MACPAC.--The Medicaid and CHIP Payment and 
        Access Commission shall conduct an independent review 
        of the alternatives to current tort litigation that are 
        implemented under grants under subsection (a) to 
        determine the impact of such alternatives on the 
        Medicaid or CHIP programs under titles XIX and XXI of 
        the Social Security Act, and their beneficiaries.
            (3) Reports.--Not later than December 31, 2016, the 
        Medicare Payment Advisory Commission and the Medicaid 
        and CHIP Payment and Access Commission shall each 
        submit to Congress a report that includes the findings 
        and recommendations of each respective Commission based 
        on independent reviews conducted under paragraphs (1) 
        and (2), including an analysis of the impact of the 
        alternatives reviewed on the efficiency and 
        effectiveness of the respective programs.
    (i) Option To Provide for Initial Planning Grants.--Of the 
funds appropriated pursuant to subsection (k), the Secretary 
may use a portion not to exceed $500,000 per State to provide 
planning grants to such States for the development of 
demonstration project applications meeting the criteria 
described in subsection (c). In selecting States to receive 
such planning grants, the Secretary shall give preference to 
those States in which State law at the time of the application 
would not prohibit the adoption of an alternative to current 
tort litigation.
    (j) Definitions.--In this section:
            (1) Health care services.--The term ``health care 
        services'' means any services provided by a health care 
        provider, or by any individual working under the 
        supervision of a health care provider, that relate to--
                    (A) the diagnosis, prevention, or treatment 
                of any human disease or impairment; or
                    (B) the assessment of the health of human 
                beings.
            (2) Health care organization.--The term ``health 
        care organization'' means any individual or entity 
        which is obligated to provide, pay for, or administer 
        health benefits under any health plan.
            (3) Health care provider.--The term ``health care 
        provider'' means any individual or entity--
                    (A) licensed, registered, or certified 
                under Federal or State laws or regulations to 
                provide health care services; or
                    (B) required to be so licensed, registered, 
                or certified but that is exempted by other 
                statute or regulation.
    (k) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section, $50,000,000 for 
the 5-fiscal year period beginning with fiscal year 2011.
    (l) Current State Efforts To Establish Alternative To Tort 
Litigation.--Nothing in this section shall be construed to 
limit any prior, current, or future efforts of any State to 
establish any alternative to tort litigation.
    (m) Rule of Construction.--Nothing in this section shall be 
construed as limiting states' authority over or responsibility 
for their state justice systems.

           PART Q--PROGRAMS TO IMPROVE THE HEALTH OF CHILDREN

SEC. 399W. [280H] GRANTS TO PROMOTE CHILDHOOD NUTRITION AND PHYSICAL 
                    ACTIVITY.

    (a) In General.--The Secretary, acting though the Director 
of the Centers for Disease Control and Prevention, shall award 
competitive grants to States and political subdivisions of 
States for the development and implementation of State and 
community-based intervention programs to promote good nutrition 
and physical activity in children and adolescents.
    (b) Eligibility.--To be eligible to receive a grant under 
this section a State or political subdivision of a State shall 
prepare and submit to the Secretary an application at such 
time, in such manner, and containing such information as the 
Secretary may require, including a plan that describes--
            (1) how the applicant proposes to develop a 
        comprehensive program of school- and community-based 
        approaches to encourage and promote good nutrition and 
        appropriate levels of physical activity with respect to 
        children or adolescents in local communities;
            (2) the manner in which the applicant shall 
        coordinate with appropriate State and local 
        authorities, such as State and local school 
        departments, State departments of health, chronic 
        disease directors, State directors of programs under 
        section 17 of the Child Nutrition Act of 1966, 5-a-day 
        coordinators, governors councils for physical activity 
        and good nutrition, and State and local parks and 
        recreation departments; and
            (3) the manner in which the applicant will evaluate 
        the effectiveness of the program carried out under this 
        section.
    (c) Use of Funds.--A State or political subdivision of a 
State shall use amount received under a grant under this 
section to--
            (1) develop, implement, disseminate, and evaluate 
        school- and community-based strategies in States to 
        reduce inactivity and improve dietary choices among 
        children and adolescents;
            (2) expand opportunities for physical activity 
        programs in school- and community-based settings; and
            (3) develop, implement, and evaluate programs that 
        promote good eating habits and physical activity 
        including opportunities for children with cognitive and 
        physical disabilities.
    (d) Technical Assistance.--The Secretary may set-aside an 
amount not to exceed 10 percent of the amount appropriated for 
a fiscal year under subsection (h) to permit the Director of 
the Centers for Disease Control and Prevention to--
            (1) provide States and political subdivisions of 
        States with technical support in the development and 
        implementation of programs under this section; and
            (2) disseminate information about effective 
        strategies and interventions in preventing and treating 
        obesity through the promotion of good nutrition and 
        physical activity.
    (e) Limitation on Administrative Costs.--Not to exceed 10 
percent of the amount of a grant awarded to the State or 
political subdivision under subsection (a) for a fiscal year 
may be used by the State or political subdivision for 
administrative expenses.
    (f ) Term.--A grant awarded under subsection (a) shall be 
for a term of 3 years.
    (g) Definition.--In this section, the term ``children and 
adolescents'' means individuals who do not exceed 18 years of 
age.
    (h) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section such sums as may 
be necessary for each of the fiscal years 2001 through 2005.

SEC. 399X. [280H-1] APPLIED RESEARCH PROGRAM.

    (a) In General.--The Secretary, acting through the Centers 
for Disease Control and Prevention and in consultation with the 
Director of the National Institutes of Health, shall--
            (1) conduct research to better understand the 
        relationship between physical activity, diet, and 
        health and factors that influence health-related 
        behaviors;
            (2) develop and evaluate strategies for the 
        prevention and treatment of obesity to be used in 
        community-based interventions and by health 
        professionals;
            (3) develop and evaluate strategies for the 
        prevention and treatment of eating disorders, such as 
        anorexia and bulimia;
            (4) conduct research to establish the prevalence, 
        consequences, and costs of childhood obesity and its 
        effects in adulthood;
            (5) identify behaviors and risk factors that 
        contribute to obesity;
            (6) evaluate materials and programs to provide 
        nutrition education to parents and teachers of children 
        in child care or pre-school and the food service staff 
        of such child care and pre-school entities; and
            (7) evaluate materials and programs that are 
        designed to educate and encourage physical activity in 
        child care and pre-school facilities.
    (b) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section such sums as may 
be necessary for each of the fiscal years 2001 through 2005.

SEC. 399Y. [280H-2] EDUCATION CAMPAIGN.

    (a) In General.--The Secretary, acting through the Director 
of the Centers for Disease Control and Prevention, and in 
collaboration with national, State, and local partners, 
physical activity organizations, nutrition experts, and health 
professional organizations, shall develop a national public 
campaign to promote and educate children and their parents 
concerning--
            (1) the health risks associated with obesity, 
        inactivity, and poor nutrition;
            (2) ways in which to incorporate physical activity 
        into daily living; and
            (3) the benefits of good nutrition and strategies 
        to improve eating habits.
    (b) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section such sums as may 
be necessary for each of the fiscal years 2001 through 2005.

SEC. 399Z. [280H-3] HEALTH PROFESSIONAL EDUCATION AND TRAINING.

    (a) In General.--The Secretary, acting through the Director 
of the Centers for Disease Control and Prevention, in 
collaboration with the Administrator of the Health Resources 
and Services Administration and the heads of other agencies, 
and in consultation with appropriate health professional 
associations, shall develop and carry out a program to educate 
and train health professionals in effective strategies to--
            (1) better identify and assess patients with 
        obesity or an eating disorder or patients at-risk of 
        becoming obese or developing an eating disorder;
            (2) counsel, refer, or treat patients with obesity 
        or an eating disorder; and
            (3) educate patients and their families about 
        effective strategies to improve dietary habits and 
        establish appropriate levels of physical activity.
    (b) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section such sums as may 
be necessary for each of the fiscal years 2001 through 2005.

SEC. 399Z-1. [280H-5] SCHOOL-BASED HEALTH CENTERS.

    (a) Definitions; Establishment of Criteria.--In this 
section:
            (1) Comprehensive primary health services.--The 
        term ``comprehensive primary health services'' means 
        the core services offered by school-based health 
        centers, which shall include the following:
                    (A) Physical.--Comprehensive health 
                assessments, diagnosis, and treatment of minor, 
                acute, and chronic medical conditions, and 
                referrals to, and follow-up for, specialty care 
                and oral and vision health services.
                    (B) Mental health.--Mental health and 
                substance use disorder assessments, crisis 
                intervention, counseling, treatment, and 
                referral to a continuum of services including 
                emergency psychiatric care, community support 
                programs, inpatient care, and outpatient 
                programs.
            (2) Medically underserved children and 
        adolescents.--
                    (A) In general.--The term ``medically 
                underserved children and adolescents'' means a 
                population of children and adolescents who are 
                residents of an area designated as a medically 
                underserved area or a health professional 
                shortage area by the Secretary.
                    (B) Criteria.--The Secretary shall 
                prescribe criteria for determining the specific 
                shortages of personal health services for 
                medically underserved children and adolescents 
                under subparagraph (A) that shall--
                            (i) take into account any comments 
                        received by the Secretary from the 
                        chief executive officer of a State and 
                        local officials in a State; and
                            (ii) include factors indicative of 
                        the health status of such children and 
                        adolescents of an area, including the 
                        ability of the residents of such area 
                        to pay for health services, the 
                        accessibility of such services, the 
                        availability of health professionals to 
                        such children and adolescents, and 
                        other factors as determined appropriate 
                        by the Secretary.
            (3) School-based health center.--The term ``school-
        based health center'' means a health clinic that--
                    (A) meets the definition of a school-based 
                health center under section 2110(c)(9)(A) of 
                the Social Security Act and is administered by 
                a sponsoring facility (as defined in section 
                2110(c)(9)(B) of the Social Security Act);
                    (B) provides, at a minimum, comprehensive 
                primary health services during school hours to 
                children and adolescents by health 
                professionals in accordance with established 
                standards, community practice, reporting laws, 
                and other State laws, including parental 
                consent and notification laws that are not 
                inconsistent with Federal law; and
                    (C) does not perform abortion services.
    (b) Authority To Award Grants.--The Secretary shall award 
grants for the costs of the operation of school-based health 
centers (referred to in this section as ``SBHCs'') that meet 
the requirements of this section.
    (c) Applications.--To be eligible to receive a grant under 
this section, an entity shall--
            (1) be an SBHC (as defined in subsection (a)(3)); 
        and
            (2) submit to the Secretary an application at such 
        time, in such manner, and containing--
                    (A) evidence that the applicant meets all 
                criteria necessary to be designated an SBHC;
                    (B) evidence of local need for the services 
                to be provided by the SBHC;
                    (C) an assurance that--
                            (i) SBHC services will be provided 
                        to those children and adolescents for 
                        whom parental or guardian consent has 
                        been obtained in cooperation with 
                        Federal, State, and local laws 
                        governing health care service provision 
                        to children and adolescents;
                            (ii) the SBHC has made and will 
                        continue to make every reasonable 
                        effort to establish and maintain 
                        collaborative relationships with other 
                        health care providers in the catchment 
                        area of the SBHC;
                            (iii) the SBHC will provide on-site 
                        access during the academic day when 
                        school is in session and 24-hour 
                        coverage through an on-call system and 
                        through its backup health providers to 
                        ensure access to services on a year-
                        round basis when the school or the SBHC 
                        is closed;
                            (iv) the SBHC will be integrated 
                        into the school environment and will 
                        coordinate health services with school 
                        personnel, such as administrators, 
                        teachers, nurses, counselors, and 
                        support personnel, as well as with 
                        other community providers co-located at 
                        the school;
                            (v) the SBHC sponsoring facility 
                        assumes all responsibility for the SBHC 
                        administration, operations, and 
                        oversight; and
                            (vi) the SBHC will comply with 
                        Federal, State, and local laws 
                        concerning patient privacy and student 
                        records, including regulations 
                        promulgated under the Health Insurance 
                        Portability and Accountability Act of 
                        1996 and section 444 of the General 
                        Education Provisions Act; and
                    (D) such other information as the Secretary 
                may require.
    (d) Preferences and Consideration.--In reviewing 
applications:
            (1) The Secretary may give preference to applicants 
        who demonstrate an ability to serve the following:
                    (A) Communities that have evidenced 
                barriers to primary health care and mental 
                health and substance use disorder prevention 
                services for children and adolescents.
                    (B) Communities with high per capita 
                numbers of children and adolescents who are 
                uninsured, underinsured, or enrolled in public 
                health insurance programs.
                    (C) Populations of children and adolescents 
                that have historically demonstrated difficulty 
                in accessing health and mental health and 
                substance use disorder prevention services.
            (2) The Secretary may give consideration to whether 
        an applicant has received a grant under subsection (a) 
        of section 4101 of the Patient Protection and 
        Affordable Care Act.
    (e) Waiver of Requirements.--The Secretary may--
            (1) under appropriate circumstances, waive the 
        application of all or part of the requirements of this 
        subsection with respect to an SBHC for not to exceed 2 
        years; and
            (2) upon a showing of good cause, waive the 
        requirement that the SBHC provide all required 
        comprehensive primary health services for a designated 
        period of time to be determined by the Secretary.
    (f) Use of Funds.--
            (1) Funds.--Funds awarded under a grant under this 
        section--
                    (A) may be used for--
                            (i) acquiring and leasing equipment 
                        (including the costs of amortizing the 
                        principle of, and paying interest on, 
                        loans for such equipment);
                            (ii) providing training related to 
                        the provision of required comprehensive 
                        primary health services and additional 
                        health services;
                            (iii) the management and operation 
                        of health center programs;
                            (iv) the payment of salaries for 
                        physicians, nurses, and other personnel 
                        of the SBHC; and
                    (B) may not be used to provide abortions.
            (2) Construction.--The Secretary may award grants 
        which may be used to pay the costs associated with 
        expanding and modernizing existing buildings for use as 
        an SBHC, including the purchase of trailers or 
        manufactured buildings to install on the school 
        property.
            (3) Limitations.--
                    (A) In general.--Any provider of services 
                that is determined by a State to be in 
                violation of a State law described in 
                subsection (a)(3)(B) with respect to activities 
                carried out at a SBHC shall not be eligible to 
                receive additional funding under this section.
                    (B) No overlapping grant period.--No entity 
                that has received funding under section 330 for 
                a grant period shall be eligible for a grant 
                under this section for with respect to the same 
                grant period.
    (g) Matching Requirement.--
            (1) In general.--Each eligible entity that receives 
        a grant under this section shall provide, from non-
        Federal sources, an amount equal to 20 percent of the 
        amount of the grant (which may be provided in cash or 
        in-kind) to carry out the activities supported by the 
        grant.
            (2) Waiver.--The Secretary may waive all or part of 
        the matching requirement described in paragraph (1) for 
        any fiscal year for the SBHC if the Secretary 
        determines that applying the matching requirement to 
        the SBHC would result in serious hardship or an 
        inability to carry out the purposes of this section.
    (h) Supplement, Not Supplant.--Grant funds provided under 
this section shall be used to supplement, not supplant, other 
Federal or State funds.
    (i) Evaluation.--The Secretary shall develop and implement 
a plan for evaluating SBHCs and monitoring quality performance 
under the awards made under this section.
    (j) Age Appropriate Services.--An eligible entity receiving 
funds under this section shall only provide age appropriate 
services through a SBHC funded under this section to an 
individual.
    (k) Parental Consent.--An eligible entity receiving funds 
under this section shall not provide services through a SBHC 
funded under this section to an individual without the consent 
of the parent or guardian of such individual if such individual 
is considered a minor under applicable State law.
    (l) Authorization of Appropriations.--For purposes of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2010 through 2014.

                  PART R--PROGRAMS RELATING TO AUTISM

SEC. 399AA. [280I] DEVELOPMENTAL DISABILITIES SURVEILLANCE AND RESEARCH 
                    PROGRAM.

    (a) Autism Spectrum Disorder and Other Developmental 
Disabilities.--
            (1) In general.--The Secretary, acting through the 
        Director of the Centers for Disease Control and 
        Prevention, may award grants or cooperative agreements 
        to eligible entities for the collection, analysis, and 
        reporting of State epidemiological data on autism 
        spectrum disorder and other developmental disabilities. 
        An eligible entity shall assist with the development 
        and coordination of State autism spectrum disorder and 
        other developmental disability surveillance efforts 
        within a region. In making such awards, the Secretary 
        may provide direct technical assistance in lieu of 
        cash.
            (2) Data standards.--In submitting epidemiological 
        data to the Secretary pursuant to paragraph (1), an 
        eligible entity shall report data according to 
        guidelines prescribed by the Director of the Centers 
        for Disease Control and Prevention, after consultation 
        with relevant State and local public health officials, 
        private sector developmental disability researchers, 
        and advocates for individuals with autism spectrum 
        disorder or other developmental disabilities.
            (3) Eligibility.--To be eligible to receive an 
        award under paragraph (1), an entity shall be a public 
        or nonprofit private entity (including a health 
        department of a State or a political subdivision of a 
        State, a university, or any other educational 
        institution), and submit to the Secretary an 
        application at such time, in such manner, and 
        containing such information as the Secretary may 
        require.
    (b) Centers of Excellence in Autism Spectrum Disorder 
Epidemiology.--
            (1) In general.--The Secretary, acting through the 
        Director of the Centers for Disease Control and 
        Prevention, shall, subject to the availability of 
        appropriations, award grants or cooperative agreements 
        for the establishment of regional centers of excellence 
        in autism spectrum disorder and other developmental 
        disabilities epidemiology for the purpose of collecting 
        and analyzing information on the number, incidence, 
        correlates, and causes of autism spectrum disorder and 
        other developmental disabilities.
            (2) Requirements.--To be eligible to receive a 
        grant or cooperative agreement under paragraph (1), an 
        entity shall submit to the Secretary an application 
        containing such agreements and information as the 
        Secretary may require, including an agreement that the 
        center to be established under the grant or cooperative 
        agreement shall operate in accordance with the 
        following:
                    (A) The center will collect, analyze, and 
                report autism spectrum disorder and other 
                developmental disability data according to 
                guidelines prescribed by the Director of the 
                Centers for Disease Control and Prevention, 
                after consultation with relevant State and 
                local public health officials, private sector 
                developmental disability researchers, and 
                advocates for individuals with developmental 
                disabilities.
                    (B) The center will develop or extend an 
                area of special research expertise (including 
                genetics, epigenetics, and epidemiological 
                research related to environmental exposures), 
                immunology, and other relevant research 
                specialty areas.
                    (C) The center will identify eligible cases 
                and controls through its surveillance system 
                and conduct research into factors which may 
                cause or increase the risk of autism spectrum 
                disorder and other developmental disabilities.
    (c) Federal Response.--The Secretary shall coordinate the 
Federal response to requests for assistance from State health, 
mental health, and education department officials regarding 
potential or alleged autism spectrum disorder or developmental 
disability clusters.
    (d) Definitions.--In this part:
            (1) Other developmental disabilities.--The term 
        ``other developmental disabilities'' has the meaning 
        given the term ``developmental disability'' in section 
        102(8) of the Developmental Disabilities Assistance and 
        Bill of Rights Act of 2000 (42 U.S.C. 15002(8)).
            (2) State.--The term ``State'' means each of the 
        several States, the District of Columbia, the 
        Commonwealth of Puerto Rico, American Samoa, Guam, the 
        Commonwealth of the Northern Mariana Islands, the 
        Virgin Islands, and the Trust Territory of the Pacific 
        Islands.
    (e) Sunset.--This section shall not apply after September 
30, 2011.

SEC. 399BB. [280I-1] AUTISM EDUCATION, EARLY DETECTION, AND 
                    INTERVENTION.

    (a) Purpose.--It is the purpose of this section--
            (1) to increase awareness, reduce barriers to 
        screening and diagnosis, promote evidence-based 
        interventions for individuals with autism spectrum 
        disorder or other developmental disabilities, and train 
        professionals to utilize valid and reliable screening 
        tools to diagnose or rule out and provide evidence-
        based interventions for children with autism spectrum 
        disorder and other developmental disabilities; and
            (2) to conduct activities under this section with a 
        focus on an interdisciplinary approach (as defined in 
        programs developed under section 501(a)(2) of the 
        Social Security Act) that will also focus on specific 
        issues for children who are not receiving an early 
        diagnosis and subsequent interventions.
    (b) In General.--The Secretary shall, subject to the 
availability of appropriations, establish and evaluate 
activities to--
            (1) provide information and education on autism 
        spectrum disorder and other developmental disabilities 
        to increase public awareness of developmental 
        milestones;
            (2) promote research into the development and 
        validation of reliable screening tools for autism 
        spectrum disorder and other developmental disabilities 
        and disseminate information regarding those screening 
        tools;
            (3) promote early screening of individuals at 
        higher risk for autism spectrum disorder and other 
        developmental disabilities as early as practicable, 
        given evidence-based screening techniques and 
        interventions;
            (4) increase the number of individuals who are able 
        to confirm or rule out a diagnosis of autism spectrum 
        disorder and other developmental disabilities;
            (5) increase the number of individuals able to 
        provide evidence-based interventions for individuals 
        diagnosed with autism spectrum disorder or other 
        developmental disabilities; and
            (6) promote the use of evidence-based interventions 
        for individuals at higher risk for autism spectrum 
        disorder and other developmental disabilities as early 
        as practicable.
    (c) Information and Education.--
            (1) In general.--In carrying out subsection (b)(1), 
        the Secretary, in collaboration with the Secretary of 
        Education and the Secretary of Agriculture, shall, 
        subject to the availability of appropriations, provide 
        culturally competent information regarding autism 
        spectrum disorder and other developmental disabilities, 
        risk factors, characteristics, identification, 
        diagnosis or rule out, and evidence-based interventions 
        to meet the needs of individuals with autism spectrum 
        disorder or other developmental disabilities and their 
        families through--
                    (A) Federal programs, including--
                            (i) the Head Start program;
                            (ii) the Early Start program;
                            (iii) the Healthy Start program;
                            (iv) programs under the Child Care 
                        and Development Block Grant Act of 
                        1990;
                            (v) programs under title XIX of the 
                        Social Security Act (particularly the 
                        Medicaid Early and Periodic Screening, 
                        Diagnosis and Treatment Program);
                            (vi) the program under title XXI of 
                        the Social Security Act (the State 
                        Children's Health Insurance Program);
                            (vii) the program under title V of 
                        the Social Security Act (the Maternal 
                        and Child Health Block Grant Program);
                            (viii) the program under parts B 
                        and C of the Individuals with 
                        Disabilities Education Act;
                            (ix) the special supplemental 
                        nutrition program for women, infants, 
                        and children established under section 
                        17 of the Child Nutrition Act of 1966 
                        (42 U.S.C. 1786); and
                            (x) the State grant program under 
                        the Rehabilitation Act of 1973.
                    (B) State licensed child care facilities; 
                and
                    (C) other community-based organizations or 
                points of entry for individuals with autism 
                spectrum disorder and other developmental 
                disabilities to receive services.
            (2) Lead agency.--
                    (A) Designation.--As a condition on the 
                provision of assistance or the conduct of 
                activities under this section with respect to a 
                State, the Secretary may require the Governor 
                of the State--
                            (i) to designate a public agency as 
                        a lead agency to coordinate the 
                        activities provided for under paragraph 
                        (1) in the State at the State level; 
                        and
                            (ii) acting through such lead 
                        agency, to make available to 
                        individuals and their family members, 
                        guardians, advocates, or authorized 
                        representatives; providers; and other 
                        appropriate individuals in the State, 
                        comprehensive culturally competent 
                        information about State and local 
                        resources regarding autism spectrum 
                        disorder and other developmental 
                        disabilities, risk factors, 
                        characteristics, identification, 
                        diagnosis or rule out, available 
                        services and supports, and evidence-
                        based interventions.
                    (B) Requirements of agency.--In designating 
                the lead agency under subparagraph (A)(i), the 
                Governor shall--
                            (i) select an agency that has 
                        demonstrated experience and expertise 
                        in--
                                    (I) autism spectrum 
                                disorder and other 
                                developmental disability 
                                issues; and
                                    (II) developing, 
                                implementing, conducting, and 
                                administering programs and 
                                delivering education, 
                                information, and referral 
                                services (including technology-
                                based curriculum-development 
                                services) to individuals with 
                                developmental disabilities and 
                                their family members, 
                                guardians, advocates or 
                                authorized representatives, 
                                providers, and other 
                                appropriate individuals locally 
                                and across the State; and
                            (ii) consider input from 
                        individuals with developmental 
                        disabilities and their family members, 
                        guardians, advocates or authorized 
                        representatives, providers, and other 
                        appropriate individuals.
                    (C) Information.--Information under 
                subparagraph (A)(ii) shall be provided 
                through--
                            (i) toll-free telephone numbers;
                            (ii) Internet websites;
                            (iii) mailings; or
                            (iv) such other means as the 
                        Governor may require.
    (d) Tools.--
            (1) In general.--To promote the use of valid and 
        reliable screening tools for autism spectrum disorder 
        and other developmental disabilities, the Secretary 
        shall develop a curriculum for continuing education to 
        assist individuals in recognizing the need for valid 
        and reliable screening tools and the use of such tools.
            (2) Collection, storage, coordination, and 
        availability.--The Secretary, in collaboration with the 
        Secretary of Education, shall provide for the 
        collection, storage, coordination, and public 
        availability of tools described in paragraph (1), 
        educational materials and other products that are used 
        by the Federal programs referred to in subsection 
        (c)(1)(A), as well as--
                    (A) programs authorized under the 
                Developmental Disabilities Assistance and Bill 
                of Rights Act of 2000;
                    (B) early intervention programs or 
                interagency coordinating councils authorized 
                under part C of the Individuals with 
                Disabilities Education Act; and
                    (C) children with special health care needs 
                programs authorized under title V of the Social 
                Security Act.
            (3) Required sharing.--In establishing mechanisms 
        and entities under this subsection, the Secretary, and 
        the Secretary of Education, shall ensure the sharing of 
        tools, materials, and products developed under this 
        subsection among entities receiving funding under this 
        section.
    (e) Diagnosis.--
            (1) Training.--The Secretary, in coordination with 
        activities conducted under title V of the Social 
        Security Act, shall, subject to the availability of 
        appropriations, expand existing interdisciplinary 
        training opportunities or opportunities to increase the 
        number of sites able to diagnose or rule out 
        individuals with autism spectrum disorder or other 
        developmental disabilities and ensure that--
                    (A) competitive grants or cooperative 
                agreements are awarded to public or nonprofit 
                agencies, including institutions of higher 
                education, to expand existing or develop new 
                maternal and child health interdisciplinary 
                leadership education in neurodevelopmental and 
                related disabilities programs (similar to the 
                programs developed under section 501(a)(2) of 
                the Social Security Act) in States that do not 
                have such a program;
                    (B) trainees under such training programs--
                            (i) receive an appropriate balance 
                        of academic, clinical, and community 
                        opportunities;
                            (ii) are culturally competent;
                            (iii) are ethnically diverse;
                            (iv) demonstrate a capacity to 
                        evaluate, diagnose or rule out, 
                        develop, and provide evidence-based 
                        interventions to individuals with 
                        autism spectrum disorder and other 
                        developmental disabilities; and
                            (v) demonstrate an ability to use a 
                        family-centered approach; and
                    (C) program sites provide culturally 
                competent services.
            (2) Technical assistance.--The Secretary may award 
        one or more grants under this section to provide 
        technical assistance to the network of 
        interdisciplinary training programs.
            (3) Best practices.--The Secretary shall promote 
        research into additional valid and reliable tools for 
        shortening the time required to confirm or rule out a 
        diagnosis of autism spectrum disorder or other 
        developmental disabilities and detecting individuals 
        with autism spectrum disorder or other developmental 
        disabilities at an earlier age.
    (f) Intervention.--The Secretary shall promote research, 
through grants or contracts, to determine the evidence-based 
practices for interventions for individuals with autism 
spectrum disorder or other developmental disabilities, develop 
guidelines for those interventions, and disseminate information 
related to such research and guidelines.
    (g) Sunset.--This section shall not apply after September 
30, 2011.

SEC. 399CC. [280I-2] INTERAGENCY AUTISM COORDINATING COMMITTEE.

    (a) Establishment.--The Secretary shall establish a 
committee, to be known as the ``Interagency Autism Coordinating 
Committee'' (in this section referred to as the ``Committee''), 
to coordinate all efforts within the Department of Health and 
Human Services concerning autism spectrum disorder.
    (b) Responsibilities.--In carrying out its duties under 
this section, the Committee shall--
            (1) develop and annually update a summary of 
        advances in autism spectrum disorder research related 
        to causes, prevention, treatment, early screening, 
        diagnosis or rule out, intervention, and access to 
        services and supports for individuals with autism 
        spectrum disorder;
            (2) monitor Federal activities with respect to 
        autism spectrum disorder;
            (3) make recommendations to the Secretary regarding 
        any appropriate changes to such activities, including 
        recommendations to the Director of NIH with respect to 
        the strategic plan developed under paragraph (5);
            (4) make recommendations to the Secretary regarding 
        public participation in decisions relating to autism 
        spectrum disorder;
            (5) develop and annually update a strategic plan 
        for the conduct of, and support for, autism spectrum 
        disorder research, including proposed budgetary 
        requirements; and
            (6) submit to the Congress such strategic plan and 
        any updates to such plan.
    (c) Membership.--
            (1) In general.--The Committee shall be composed 
        of--
                    (A) the Director of the Centers for Disease 
                Control and Prevention;
                    (B) the Director of the National Institutes 
                of Health, and the Directors of such national 
                research institutes of the National Institutes 
                of Health as the Secretary determines 
                appropriate;
                    (C) the heads of such other agencies as the 
                Secretary determines appropriate;
                    (D) representatives of other Federal 
                Governmental agencies that serve individuals 
                with autism spectrum disorder such as the 
                Department of Education; and
                    (E) the additional members appointed under 
                paragraph (2).
            (2) Additional members.--Not fewer than 6 members 
        of the Committee, or 1/3 of the total membership of the 
        Committee, whichever is greater, shall be composed of 
        non-Federal public members to be appointed by the 
        Secretary, of which--
                    (A) at least one such member shall be an 
                individual with a diagnosis of autism spectrum 
                disorder;
                    (B) at least one such member shall be a 
                parent or legal guardian of an individual with 
                an autism spectrum disorder; and
                    (C) at least one such member shall be a 
                representative of leading research, advocacy, 
                and service organizations for individuals with 
                autism spectrum disorder.
    (d) Administrative Support; Terms of Service; Other 
Provisions.--The following provisions shall apply with respect 
to the Committee:
            (1) The Committee shall receive necessary and 
        appropriate administrative support from the Secretary.
            (2) Members of the Committee appointed under 
        subsection (c)(2) shall serve for a term of 4 years, 
        and may be reappointed for one or more additional 4 
        year term. Any member appointed to fill a vacancy for 
        an unexpired term shall be appointed for the remainder 
        of such term. A member may serve after the expiration 
        of the member's term until a successor has taken 
        office.
            (3) The Committee shall meet at the call of the 
        chairperson or upon the request of the Secretary. The 
        Committee shall meet not fewer than 2 times each year.
            (4) All meetings of the Committee shall be public 
        and shall include appropriate time periods for 
        questions and presentations by the public.
    (e) Subcommittees; Establishment and Membership.--In 
carrying out its functions, the Committee may establish 
subcommittees and convene workshops and conferences. Such 
subcommittees shall be composed of Committee members and may 
hold such meetings as are necessary to enable the subcommittees 
to carry out their duties.
    (f) Sunset.--This section shall not apply after September 
30, 2011, and the Committee shall be terminated on such date.

SEC. 399DD. [280I-3] REPORT TO CONGRESS.

    (a) In General.--Not later than 4 years after the date of 
enactment of the Combating Autism Act of 2006, the Secretary, 
in coordination with the Secretary of Education, shall prepare 
and submit to the Health, Education, Labor, and Pensions 
Committee of the Senate and the Energy and Commerce Committee 
of the House of Representatives a progress report on activities 
related to autism spectrum disorder and other developmental 
disabilities.
    (b) Contents.--The report submitted under subsection (a) 
shall contain--
            (1) a description of the progress made in 
        implementing the provisions of the Combating Autism Act 
        of 2006;
            (2) a description of the amounts expended on the 
        implementation of the particular provisions of 
        Combating Autism Act of 2006;
            (3) information on the incidence of autism spectrum 
        disorder and trend data of such incidence since the 
        date of enactment of the Combating Autism Act of 2006;
            (4) information on the average age of diagnosis for 
        children with autism spectrum disorder and other 
        disabilities, including how that age may have changed 
        over the 4-year period beginning on the date of 
        enactment of this Act;
            (5) information on the average age for intervention 
        for individuals diagnosed with autism spectrum disorder 
        and other developmental disabilities, including how 
        that age may have changed over the 4-year period 
        beginning on the date of enactment of this Act;
            (6) information on the average time between initial 
        screening and then diagnosis or rule out for 
        individuals with autism spectrum disorder or other 
        developmental disabilities, as well as information on 
        the average time between diagnosis and evidence-based 
        intervention for individuals with autism spectrum 
        disorder or other developmental disabilities;
            (7) information on the effectiveness and outcomes 
        of interventions for individuals diagnosed with autism 
        spectrum disorder, including by various subtypes, and 
        other developmental disabilities and how the age of the 
        child may affect such effectiveness;
            (8) information on the effectiveness and outcomes 
        of innovative and newly developed intervention 
        strategies for individuals with autism spectrum 
        disorder or other developmental disabilities; and
            (9) information on services and supports provided 
        to individuals with autism spectrum disorder and other 
        developmental disabilities who have reached the age of 
        majority (as defined for purposes of section 615(m) of 
        the Individuals with Disabilities Education Act (20 
        U.S.C. 1415(m)).

SEC. 399EE. [280I-4] AUTHORIZATION OF APPROPRIATIONS.

    (a) Developmental Disabilities Surveillance and Research 
Program.--To carry out section 399AA, there are authorized to 
be appropriated the following:
            (1) For fiscal year 2007, $15,000,000.
            (2) For fiscal year 2008, $16,500,000.
            (3) For fiscal year 2009, $18,000,000.
            (4) For fiscal year 2010, $19,500,000.
            (5) For fiscal year 2011, $21,000,000.
    (b) Autism Education, Early Detection, and Intervention.--
To carry out section 399BB, there are authorized to be 
appropriated the following:
            (1) For fiscal year 2007, $32,000,000.
            (2) For fiscal year 2008, $37,000,000.
            (3) For fiscal year 2009, $42,000,000.
            (4) For fiscal year 2010, $47,000,000.
            (5) For fiscal year 2011, $52,000,000.
    (c) Interagency Autism Coordinating Committee; Certain 
Other Programs.--To carry out section 399CC, 409C, and section 
404H, there are authorized to be appropriated the following:
            (1) For fiscal year 2007, $100,000,000.
            (2) For fiscal year 2008, $114,500,000.
            (3) For fiscal year 2009, $129,000,000.
            (4) For fiscal year 2010, $143,500,000.
            (5) For fiscal year 2011, $158,000,000.

                  PART S--HEALTH CARE QUALITY PROGRAMS

  Subpart I--National Strategy for Quality Improvement in Health Care

SEC. 399HH. [280J] NATIONAL STRATEGY FOR QUALITY IMPROVEMENT IN HEALTH 
                    CARE.

    (a) Establishment of National Strategy and Priorities.--
            (1) National strategy.--The Secretary, through a 
        transparent collaborative process, shall establish a 
        national strategy to improve the delivery of health 
        care services, patient health outcomes, and population 
        health.
            (2) Identification of priorities.--
                    (A) In general.--The Secretary shall 
                identify national priorities for improvement in 
                developing the strategy under paragraph (1).
                    (B) Requirements.--The Secretary shall 
                ensure that priorities identified under 
                subparagraph (A) will--
                            (i) have the greatest potential for 
                        improving the health outcomes, 
                        efficiency, and patient-centeredness of 
                        health care for all populations, 
                        including children and vulnerable 
                        populations;
                            (ii) identify areas in the delivery 
                        of health care services that have the 
                        potential for rapid improvement in the 
                        quality and efficiency of patient care;
                            (iii) address gaps in quality, 
                        efficiency, comparative effectiveness 
                        information (taking into consideration 
                        the limitations set forth in 
                        subsections (c) and (d) of section 1182 
                        of the Social Security Act), and health 
                        outcomes measures and data aggregation 
                        techniques;
                            (iv) improve Federal payment policy 
                        to emphasize quality and efficiency;
                            (v) enhance the use of health care 
                        data to improve quality, efficiency, 
                        transparency, and outcomes;
                            (vi) address the health care 
                        provided to patients with high-cost 
                        chronic diseases;
                            (vii) improve research and 
                        dissemination of strategies and best 
                        practices to improve patient safety and 
                        reduce medical errors, preventable 
                        admissions and readmissions, and health 
                        care-associated infections;
                            (viii) reduce health disparities 
                        across health disparity populations (as 
                        defined in section 485E) and geographic 
                        areas; and
                            (ix) address other areas as 
                        determined appropriate by the 
                        Secretary.
                    (C) Considerations.--In identifying 
                priorities under subparagraph (A), the 
                Secretary shall take into consideration the 
                recommendations submitted by the entity with a 
                contract under section 1890(a) of the Social 
                Security Act and other stakeholders.
                    (D) Coordination with state agencies.--The 
                Secretary shall collaborate, coordinate, and 
                consult with State agencies responsible for 
                administering the Medicaid program under title 
                XIX of the Social Security Act and the 
                Children's Health Insurance Program under title 
                XXI of such Act with respect to developing and 
                disseminating strategies, goals, models, and 
                timetables that are consistent with the 
                national priorities identified under 
                subparagraph (A).
    (b) Strategic Plan.--
            (1) In general.--The national strategy shall 
        include a comprehensive strategic plan to achieve the 
        priorities described in subsection (a).
            (2) Requirements.--The strategic plan shall include 
        provisions for addressing, at a minimum, the following:
                    (A) Coordination among agencies within the 
                Department, which shall include steps to 
                minimize duplication of efforts and utilization 
                of common quality measures, where available. 
                Such common quality measures shall be measures 
                identified by the Secretary under section 1139A 
                or 1139B of the Social Security Act or endorsed 
                under section 1890 of such Act.
                    (B) Agency-specific strategic plans to 
                achieve national priorities.
                    (C) Establishment of annual benchmarks for 
                each relevant agency to achieve national 
                priorities.
                    (D) A process for regular reporting by the 
                agencies to the Secretary on the implementation 
                of the strategic plan.
                    (E) Strategies to align public and private 
                payers with regard to quality and patient 
                safety efforts.
                    (F) Incorporating quality improvement and 
                measurement in the strategic plan for health 
                information technology required by the American 
                Recovery and Reinvestment Act of 2009 (Public 
                Law 111-5).
    (c) Periodic Update of National Strategy.--The Secretary 
shall update the national strategy not less than annually. Any 
such update shall include a review of short- and long-term 
goals.
    (d) Submission and Availability of National Strategy and 
Updates.--
            (1) Deadline for initial submission of national 
        strategy.--Not later than January 1, 2011, the 
        Secretary shall submit to the relevant committees of 
        Congress the national strategy described in subsection 
        (a).
            (2) Updates.--
                    (A) In general.--The Secretary shall submit 
                to the relevant committees of Congress an 
                annual update to the strategy described in 
                paragraph (1).
                    (B) Information submitted.--Each update 
                submitted under subparagraph (A) shall 
                include--
                            (i) a review of the short- and 
                        long-term goals of the national 
                        strategy and any gaps in such strategy;
                            (ii) an analysis of the progress, 
                        or lack of progress, in meeting such 
                        goals and any barriers to such 
                        progress;
                            (iii) the information reported 
                        under section 1139A of the Social 
                        Security Act, consistent with the 
                        reporting requirements of such section; 
                        and
                            (iv) in the case of an update 
                        required to be submitted on or after 
                        January 1, 2014, the information 
                        reported under section 1139B(b)(4) of 
                        the Social Security Act, consistent 
                        with the reporting requirements of such 
                        section.
                    (C) Satisfaction of other reporting 
                requirements.--Compliance with the requirements 
                of clauses (iii) and (iv) of subparagraph (B) 
                shall satisfy the reporting requirements under 
                sections 1139A(a)(6) and 1139B(b)(4), 
                respectively, of the Social Security Act.
    (e) Health Care Quality Internet Website.--Not later than 
January 1, 2011, the Secretary shall create an Internet website 
to make public information regarding--
            (1) the national priorities for health care quality 
        improvement established under subsection (a)(2);
            (2) the agency-specific strategic plans for health 
        care quality described in subsection (b)(2)(B); and
            (3) other information, as the Secretary determines 
        to be appropriate.

SEC. 399II. [280J-1] COLLECTION AND ANALYSIS OF DATA FOR QUALITY AND 
                    RESOURCE USE MEASURES.

    (a) In General.--
            (1) Establishment of strategic framework.--The 
        Secretary shall establish and implement an overall 
        strategic framework to carry out the public reporting 
        of performance information, as described in section 
        399JJ. Such strategic framework may include methods and 
        related timelines for implementing nationally 
        consistent data collection, data aggregation, and 
        analysis methods.
            (2) Collection and aggregation of data.--The 
        Secretary shall collect and aggregate consistent data 
        on quality and resource use measures from information 
        systems used to support health care delivery, and may 
        award grants or contracts for this purpose. The 
        Secretary shall align such collection and aggregation 
        efforts with the requirements and assistance regarding 
        the expansion of health information technology systems, 
        the interoperability of such technology systems, and 
        related standards that are in effect on the date of 
        enactment of the Patient Protection and Affordable Care 
        Act.
            (3) Scope.--The Secretary shall ensure that the 
        data collection, data aggregation, and analysis systems 
        described in paragraph (1) involve an increasingly 
        broad range of patient populations, providers, and 
        geographic areas over time.
    (b) Grants or Contracts for Data Collection.--
            (1) In general.--The Secretary may award grants or 
        contracts to eligible entities to support new, or 
        improve existing, efforts to collect and aggregate 
        quality and resource use measures described under 
        subsection (c).
            (2) Eligible entities.--To be eligible for a grant 
        or contract under this subsection, an entity shall--
                    (A) be--
                            (i) a multi-stakeholder entity that 
                        coordinates the development of methods 
                        and implementation plans for the 
                        consistent reporting of summary quality 
                        and cost information;
                            (ii) an entity capable of 
                        submitting such summary data for a 
                        particular population and providers, 
                        such as a disease registry, regional 
                        collaboration, health plan 
                        collaboration, or other population-wide 
                        source; or
                            (iii) a Federal Indian Health 
                        Service program or a health program 
                        operated by an Indian tribe (as defined 
                        in section 4 of the Indian Health Care 
                        Improvement Act);
                    (B) promote the use of the systems that 
                provide data to improve and coordinate patient 
                care;
                    (C) support the provision of timely, 
                consistent quality and resource use information 
                to health care providers, and other groups and 
                organizations as appropriate, with an 
                opportunity for providers to correct inaccurate 
                measures; and
                    (D) agree to report, as determined by the 
                Secretary, measures on quality and resource use 
                to the public in accordance with the public 
                reporting process established under section 
                399JJ.
    (c) Consistent Data Aggregation.--The Secretary may award 
grants or contracts under this section only to entities that 
enable summary data that can be integrated and compared across 
multiple sources. The Secretary shall provide standards for the 
protection of the security and privacy of patient data.
    (d) Matching Funds.--The Secretary may not award a grant or 
contract under this section to an entity unless the entity 
agrees that it will make available (directly or through 
contributions from other public or private entities) non-
Federal contributions toward the activities to be carried out 
under the grant or contract in an amount equal to $1 for each 
$5 of Federal funds provided under the grant or contract. Such 
non-Federal matching funds may be provided directly or through 
donations from public or private entities and may be in cash or 
in-kind, fairly evaluated, including plant, equipment, or 
services.
    (e) Authorization of Appropriations.--To carry out this 
section, there are authorized to be appropriated such sums as 
may be necessary for fiscal years 2010 through 2014.

SEC. 399JJ. [280J-2] PUBLIC REPORTING OF PERFORMANCE INFORMATION.

    (a) Development of Performance Websites.--The Secretary 
shall make available to the public, through standardized 
Internet websites, performance information summarizing data on 
quality measures. Such information shall be tailored to respond 
to the differing needs of hospitals and other institutional 
health care providers, physicians and other clinicians, 
patients, consumers, researchers, policymakers, States, and 
other stakeholders, as the Secretary may specify.
    (b) Information on Conditions.--The performance information 
made publicly available on an Internet website, as described in 
subsection (a), shall include information regarding clinical 
conditions to the extent such information is available, and the 
information shall, where appropriate, be provider-specific and 
sufficiently disaggregated and specific to meet the needs of 
patients with different clinical conditions.
    (c) Consultation.--
            (1) In general.--In carrying out this section, the 
        Secretary shall consult with the entity with a contract 
        under section 1890(a) of the Social Security Act, and 
        other entities, as appropriate, to determine the type 
        of information that is useful to stakeholders and the 
        format that best facilitates use of the reports and of 
        performance reporting Internet websites.
            (2) Consultation with stakeholders.--The entity 
        with a contract under section 1890(a) of the Social 
        Security Act shall convene multi-stakeholder groups, as 
        described in such section, to review the design and 
        format of each Internet website made available under 
        subsection (a) and shall transmit to the Secretary the 
        views of such multi-stakeholder groups with respect to 
        each such design and format.
    (d) Coordination.--Where appropriate, the Secretary shall 
coordinate the manner in which data are presented through 
Internet websites described in subsection (a) and for public 
reporting of other quality measures by the Secretary, including 
such quality measures under title XVIII of the Social Security 
Act.
    (e) Authorization of Appropriations.--To carry out this 
section, there are authorized to be appropriated such sums as 
may be necessary for fiscal years 2010 through 2014.

SEC. 399KK. [280J-3] QUALITY IMPROVEMENT PROGRAM FOR HOSPITALS WITH A 
                    HIGH SEVERITY ADJUSTED READMISSION RATE.

    (a) Establishment.--
            (1) In general.--Not later than 2 years after the 
        date of enactment of this section, the Secretary shall 
        make available a program for eligible hospitals to 
        improve their readmission rates through the use of 
        patient safety organizations (as defined in section 
        921(4)).
            (2) Eligible hospital defined.--In this subsection, 
        the term ``eligible hospital'' means a hospital that 
        the Secretary determines has a high rate of risk 
        adjusted readmissions for the conditions described in 
        section 1886(q)(8)(A) of the Social Security Act and 
        has not taken appropriate steps to reduce such 
        readmissions and improve patient safety as evidenced 
        through historically high rates of readmissions, as 
        determined by the Secretary.
            (3) Risk adjustment.--The Secretary shall utilize 
        appropriate risk adjustment measures to determine 
        eligible hospitals.
    (b) Report to the Secretary.--As determined appropriate by 
the Secretary, eligible hospitals and patient safety 
organizations working with those hospitals shall report to the 
Secretary on the processes employed by the hospital to improve 
readmission rates and the impact of such processes on 
readmission rates.

             PART T--ORAL HEALTHCARE PREVENTION ACTIVITIES

SEC. 399LL. [280K] ORAL HEALTHCARE PREVENTION EDUCATION CAMPAIGN.

    (a) Establishment.--The Secretary, acting through the 
Director of the Centers for Disease Control and Prevention and 
in consultation with professional oral health organizations, 
shall, subject to the availability of appropriations, establish 
a 5-year national, public education campaign (referred to in 
this section as the ``campaign'') that is focused on oral 
healthcare prevention and education, including prevention of 
oral disease such as early childhood and other caries, 
periodontal disease, and oral cancer.
    (b) Requirements.--In establishing the campaign, the 
Secretary shall--
            (1) ensure that activities are targeted towards 
        specific populations such as children, pregnant women, 
        parents, the elderly, individuals with disabilities, 
        and ethnic and racial minority populations, including 
        Indians, Alaska Natives and Native Hawaiians (as 
        defined in section 4(c) of the Indian Health Care 
        Improvement Act) in a culturally and linguistically 
        appropriate manner; and
            (2) utilize science-based strategies to convey oral 
        health prevention messages that include, but are not 
        limited to, community water fluoridation and dental 
        sealants.
    (c) Planning and Implementation.--Not later than 2 years 
after the date of enactment of this section, the Secretary 
shall begin implementing the 5-year campaign. During the 2-year 
period referred to in the previous sentence, the Secretary 
shall conduct planning activities with respect to the campaign.

SEC. 399LL-1. [280K-1] RESEARCH-BASED DENTAL CARIES DISEASE MANAGEMENT.

    (a) In General.--The Secretary, acting through the Director 
of the Centers for Disease Control and Prevention, shall award 
demonstration grants to eligible entities to demonstrate the 
effectiveness of research-based dental caries disease 
management activities.
    (b) Eligibility.--To be eligible for a grant under this 
section, an entity shall--
            (1) be a community-based provider of dental 
        services (as defined by the Secretary), including a 
        Federally-qualified health center, a clinic of a 
        hospital owned or operated by a State (or by an 
        instrumentality or a unit of government within a 
        State), a State or local department of health, a dental 
        program of the Indian Health Service, an Indian tribe 
        or tribal organization, or an urban Indian organization 
        (as such terms are defined in section 4 of the Indian 
        Health Care Improvement Act), a health system provider, 
        a private provider of dental services, medical, dental, 
        public health, nursing, nutrition educational 
        institutions, or national organizations involved in 
        improving children's oral health; and
            (2) submit to the Secretary an application at such 
        time, in such manner, and containing such information 
        as the Secretary may require.
    (c) Use of Funds.--A grantee shall use amounts received 
under a grant under this section to demonstrate the 
effectiveness of research-based dental caries disease 
management activities.
    (d) Use of Information.--The Secretary shall utilize 
information generated from grantees under this section in 
planning and implementing the public education campaign under 
section 399LL.

SEC. 399LL-2. [280K-2] AUTHORIZATION OF APPROPRIATIONS.

    There is authorized to be appropriated to carry out this 
part, such sums as may be necessary.

                PART U--EMPLOYER-BASED WELLNESS PROGRAM

SEC. 399MM. [280L] TECHNICAL ASSISTANCE FOR EMPLOYER-BASED WELLNESS 
                    PROGRAMS.

    In order to expand the utilization of evidence-based 
prevention and health promotion approaches in the workplace, 
the Director shall--
            (1) provide employers (including small, medium, and 
        large employers, as determined by the Director) with 
        technical assistance, consultation, tools, and other 
        resources in evaluating such employers' employer-based 
        wellness programs, including--
                    (A) measuring the participation and methods 
                to increase participation of employees in such 
                programs;
                    (B) developing standardized measures that 
                assess policy, environmental and systems 
                changes necessary to have a positive health 
                impact on employees' health behaviors, health 
                outcomes, and health care expenditures; and
                    (C) evaluating such programs as they relate 
                to changes in the health status of employees, 
                the absenteeism of employees, the productivity 
                of employees, the rate of workplace injury, and 
                the medical costs incurred by employees; and
            (2) build evaluation capacity among workplace staff 
        by training employers on how to evaluate employer-based 
        wellness programs and ensuring evaluation resources, 
        technical assistance, and consultation are available to 
        workplace staff as needed through such mechanisms as 
        web portals, call centers, or other means.

SEC. 399MM-1. [280L-1] NATIONAL WORKSITE HEALTH POLICIES AND PROGRAMS 
                    STUDY.

    (a) In General.--In order to assess, analyze, and monitor 
over time data about workplace policies and programs, and to 
develop instruments to assess and evaluate comprehensive 
workplace chronic disease prevention and health promotion 
programs, policies and practices, not later than 2 years after 
the date of enactment of this part, and at regular intervals 
(to be determined by the Director) thereafter, the Director 
shall conduct a national worksite health policies and programs 
survey to assess employer-based health policies and programs.
    (b) Report.--Upon the completion of each study under 
subsection (a), the Director shall submit to Congress a report 
that includes the recommendations of the Director for the 
implementation of effective employer-based health policies and 
programs.

SEC. 399MM-2. [280L-2] PRIORITIZATION OF EVALUATION BY SECRETARY.

    The Secretary shall evaluate, in accordance with this part, 
all programs funded through the Centers for Disease Control and 
Prevention before conducting such an evaluation of privately 
funded programs unless an entity with a privately funded 
wellness program requests such an evaluation.

SEC. 399MM-3. [280L-3] PROHIBITION OF FEDERAL WORKPLACE WELLNESS 
                    REQUIREMENTS.

    Notwithstanding any other provision of this part, any 
recommendations, data, or assessments carried out under this 
part shall not be used to mandate requirements for workplace 
wellness programs.

         PART V--PROGRAMS RELATING TO BREAST HEALTH AND CANCER

SEC. 399NN. [280M] YOUNG WOMEN'S BREAST HEALTH AWARENESS AND SUPPORT OF 
                    YOUNG WOMEN DIAGNOSED WITH BREAST CANCER.

    (a) Public Education Campaign.--
            (1) In general.--The Secretary, acting through the 
        Director of the Centers for Disease Control and 
        Prevention, shall conduct a national evidence-based 
        education campaign to increase awareness of young 
        women's knowledge regarding--
                    (A) breast health in young women of all 
                racial, ethnic, and cultural backgrounds;
                    (B) breast awareness and good breast health 
                habits;
                    (C) the occurrence of breast cancer and the 
                general and specific risk factors in women who 
                may be at high risk for breast cancer based on 
                familial, racial, ethnic, and cultural 
                backgrounds such as Ashkenazi Jewish 
                populations;
                    (D) evidence-based information that would 
                encourage young women and their health care 
                professional to increase early detection of 
                breast cancers; and
                    (E) the availability of health information 
                and other resources for young women diagnosed 
                with breast cancer.
            (2) Evidence-based, age appropriate messages.--The 
        campaign shall provide evidence-based, age-appropriate 
        messages and materials as developed by the Centers for 
        Disease Control and Prevention and the Advisory 
        Committee established under paragraph (4).
            (3) Media campaign.--In conducting the education 
        campaign under paragraph (1), the Secretary shall award 
        grants to entities to establish national multimedia 
        campaigns oriented to young women that may include 
        advertising through television, radio, print media, 
        billboards, posters, all forms of existing and 
        especially emerging social networking media, other 
        Internet media, and any other medium determined 
        appropriate by the Secretary.
            (4) Advisory committee.--
                    (A) Establishment.--Not later than 60 days 
                after the date of the enactment of this 
                section, the Secretary, acting through the 
                Director of the Centers for Disease Control and 
                Prevention, shall establish an advisory 
                committee to assist in creating and conducting 
                the education campaigns under paragraph (1) and 
                subsection (b)(1).
                    (B) Membership.--The Secretary, acting 
                through the Director of the Centers for Disease 
                Control and Prevention, shall appoint to the 
                advisory committee under subparagraph (A) such 
                members as deemed necessary to properly advise 
                the Secretary, and shall include organizations 
                and individuals with expertise in breast 
                cancer, disease prevention, early detection, 
                diagnosis, public health, social marketing, 
                genetic screening and counseling, treatment, 
                rehabilitation, palliative care, and 
                survivorship in young women.
    (b) Health Care Professional Education Campaign.--The 
Secretary, acting through the Director of the Centers for 
Disease Control and Prevention, and in consultation with the 
Administrator of the Health Resources and Services 
Administration, shall conduct an education campaign among 
physicians and other health care professionals to increase 
awareness--
            (1) of breast health, symptoms, and early diagnosis 
        and treatment of breast cancer in young women, 
        including specific risk factors such as family history 
        of cancer and women that may be at high risk for breast 
        cancer, such as Ashkenazi Jewish population;
            (2) on how to provide counseling to young women 
        about their breast health, including knowledge of their 
        family cancer history and importance of providing 
        regular clinical breast examinations;
            (3) concerning the importance of discussing healthy 
        behaviors, and increasing awareness of services and 
        programs available to address overall health and 
        wellness, and making patient referrals to address 
        tobacco cessation, good nutrition, and physical 
        activity;
            (4) on when to refer patients to a health care 
        provider with genetics expertise;
            (5) on how to provide counseling that addresses 
        long-term survivorship and health concerns of young 
        women diagnosed with breast cancer; and
            (6) on when to provide referrals to organizations 
        and institutions that provide credible health 
        information and substantive assistance and support to 
        young women diagnosed with breast cancer.
    (c) Prevention Research Activities.--The Secretary, acting 
through--
            (1) the Director of the Centers for Disease Control 
        and Prevention, shall conduct prevention research on 
        breast cancer in younger women, including--
                    (A) behavioral, survivorship studies, and 
                other research on the impact of breast cancer 
                diagnosis on young women;
                    (B) formative research to assist with the 
                development of educational messages and 
                information for the public, targeted 
                populations, and their families about breast 
                health, breast cancer, and healthy lifestyles;
                    (C) testing and evaluating existing and new 
                social marketing strategies targeted at young 
                women; and
                    (D) surveys of health care providers and 
                the public regarding knowledge, attitudes, and 
                practices related to breast health and breast 
                cancer prevention and control in high-risk 
                populations; and
            (2) the Director of the National Institutes of 
        Health, shall conduct research to develop and validate 
        new screening tests and methods for prevention and 
        early detection of breast cancer in young women.
    (d) Support for Young Women Diagnosed With Breast Cancer.--
            (1) In general.--The Secretary shall award grants 
        to organizations and institutions to provide health 
        information from credible sources and substantive 
        assistance directed to young women diagnosed with 
        breast cancer and pre-neoplastic breast diseases.
            (2) Priority.--In making grants under paragraph 
        (1), the Secretary shall give priority to applicants 
        that deal specifically with young women diagnosed with 
        breast cancer and pre-neoplastic breast disease.
    (e) No Duplication of Effort.--In conducting an education 
campaign or other program under subsections (a), (b), (c), or 
(d), the Secretary shall avoid duplicating other existing 
Federal breast cancer education efforts.
    (f) Measurement; Reporting.--The Secretary, acting through 
the Director of the Centers for Disease Control and Prevention, 
shall--
            (1) measure--
                    (A) young women's awareness regarding 
                breast health, including knowledge of family 
                cancer history, specific risk factors and early 
                warning signs, and young women's proactive 
                efforts at early detection;
                    (B) the number or percentage of young women 
                utilizing information regarding lifestyle 
                interventions that foster healthy behaviors;
                    (C) the number or percentage of young women 
                receiving regular clinical breast exams; and
                    (D) the number or percentage of young women 
                who perform breast self exams, and the 
                frequency of such exams, before the 
                implementation of this section;
            (2) not less than every 3 years, measure the impact 
        of such activities; and
            (3) submit reports to the Congress on the results 
        of such measurements.
    (g) Definition.--In this section, the term ``young women'' 
means women 15 to 44 years of age.
    (h) Authorization of Appropriations.--To carry out 
subsections (a), (b), (c)(1), and (d), there are authorized to 
be appropriated $9,000,000 for each of the fiscal years 2010 
through 2014.ATTORNEY: pmg/FD (June 24, 1999) deg.
                 TITLE IV--NATIONAL RESEARCH INSTITUTES

                 Part A--National Institutes of Health

SEC. 401. [281] ORGANIZATION OF NATIONAL INSTITUTES OF HEALTH.

    (a) Relation to Public Health Service.--The National 
Institutes of Health is an agency of the Service. \1\
---------------------------------------------------------------------------
    \1\ See footnote for section 202.
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    (b) National Research Institutes and National Centers.--The 
following agencies of the National Institutes of Health are 
national research institutes or national centers:
            (1) The National Cancer Institute.
            (2) The National Heart, Lung, and Blood Institute.
            (3) The National Institute of Diabetes and 
        Digestive and Kidney Diseases.
            (4) The National Institute of Arthritis and 
        Musculoskeletal and Skin Diseases.
            (5) The National Institute on Aging.
            (6) The National Institute of Allergy and 
        Infectious Diseases.
            (7) The Eunice Kennedy Shriver National Institute 
        of Child Health and Human Development.
            (8) The National Institute of Dental and 
        Craniofacial Research. \2\
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    \2\ Section 212 of the Departments of Labor, Health and Human 
Services, and Education, and Related Agencies Appropriations Act, 1999 
(as contained in section 101(f) of division A of Public Law 105-277; 
112 Stat. 2681-359) amended subparagraph (H) to read as provided above, 
thereby indicating the intent of the Congress to change the designation 
of the Institute. (The former designation was the National Institute of 
Dental Research.) Conforming changes were not, however, made to section 
453 or the related subpart heading, or to the reference in section 
409A(a).
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            (9) The National Eye Institute.
            (10) The National Institute of Neurological 
        Disorders and Stroke.
            (11) The National Institute on Deafness and Other 
        Communication Disorders.
            (12) The National Institute on Alcohol Abuse and 
        Alcoholism.
            (13) The National Institute on Drug Abuse.
            (14) The National Institute of Mental Health.
            (15) The National Institute of General Medical 
        Sciences.
            (16) The National Institute of Environmental Health 
        Sciences.
            (17) The National Institute of Nursing Research.
            (18) The National Institute of Biomedical Imaging 
        and Bioengineering.
            (19) The National Human Genome Research Institute.
            (20) The National Library of Medicine.
            (21) The National Center for Research Resources.
            (22) The John E. Fogarty International Center for 
        Advanced Study in the Health Sciences.
            (23) The National Center for Complementary and 
        Alternative Medicine.
            (24) The National Institute on Minority Health and 
        Health Disparities.
            (25) Any other national center that, as an agency 
        separate from any national research institute, was 
        established within the National Institutes of Health as 
        of the day before the date of the enactment of the 
        National Institutes of Health Reform Act of 2006.
    (c) Division of Program Coordination, Planning, and 
Strategic Initiatives.--
            (1) In general.--Within the Office of the Director 
        of the National Institutes of Health, there shall be a 
        Division of Program Coordination, Planning, and 
        Strategic Initiatives (referred to in this subsection 
        as the ``Division'').
            (2) Offices within division.--
                    (A) Offices.--The following offices are 
                within the Division: The Office of AIDS 
                Research, the Office of Research on Women's 
                Health, the Office of Behavioral and Social 
                Sciences Research, the Office of Disease 
                Prevention, the Office of Dietary Supplements, 
                the Office of Rare Diseases, and any other 
                office located within the Office of the 
                Director of NIH as of the day before the date 
                of the enactment of the National Institutes of 
                Health Reform Act of 2006. In addition to such 
                offices, the Director of NIH may establish 
                within the Division such additional offices or 
                other administrative units as the Director 
                determines to be appropriate.
                    (B) Authorities.--Each office in the 
                Division--
                            (i) shall continue to carry out the 
                        authorities that were in effect for the 
                        office before the date of enactment 
                        referred to in subparagraph (A); and
                            (ii) shall, as determined 
                        appropriate by the Director of NIH, 
                        support the Division with respect to 
                        the authorities described in section 
                        402(b)(7).
    (d) Organization.--
            (1) Number of institutes and centers.--In the 
        National Institutes of Health, the number of national 
        research institutes and national centers may not exceed 
        a total of 27, including any such institutes or centers 
        established under authority of paragraph (2) or under 
        authority of this title as in effect on the day before 
        the date of the enactment of the National Institutes of 
        Health Reform Act of 2006.
            (2) Reorganization of institutes.--
                    (A) In general.--The Secretary may 
                establish in the National Institutes of Health 
                one or more additional national research 
                institutes to conduct and support research, 
                training, health information, and other 
                programs with respect to any particular disease 
                or groups of diseases or any other aspect of 
                human health if--
                            (i) the Secretary determines that 
                        an additional institute is necessary to 
                        carry out such activities; and
                            (ii) the additional institute is 
                        not established before the expiration 
                        of 180 days after the Secretary has 
                        provided the Committee on Energy and 
                        Commerce of the House of 
                        Representatives and the Committee on 
                        Health, Education, Labor, and Pensions 
                        of the Senate written notice of the 
                        determination made under clause (i) 
                        with respect to the institute.
                    (B) Additional authority.--The Secretary 
                may reorganize the functions of any national 
                research institute and may abolish any national 
                research institute if the Secretary determines 
                that the institute is no longer required. A 
                reorganization or abolition may not take effect 
                under this paragraph before the expiration of 
                180 days after the Secretary has provided the 
                Committee on Energy and Commerce of the House 
                of Representatives and the Committee on Health, 
                Education, Labor, and Pensions of the Senate 
                written notice of the reorganization or 
                abolition.
            (3) Reorganization of office of director.--
        Notwithstanding subsection (c), the Director of NIH 
        may, after a series of public hearings, and with the 
        approval of the Secretary, reorganize the offices 
        within the Office of the Director, including the 
        addition, removal, or transfer of functions of such 
        offices, and the establishment or termination of such 
        offices, if the Director determines that the overall 
        management and operation of programs and activities 
        conducted or supported by such offices would be more 
        efficiently carried out under such a reorganization.
            (4) Internal reorganization of institutes and 
        centers.--Notwithstanding any conflicting provisions of 
        this title, the director of a national research 
        institute or a national center may, after a series of 
        public hearings and with the approval of the Director 
        of NIH, reorganize the divisions, centers, or other 
        administrative units within such institute or center, 
        including the addition, removal, or transfer of 
        functions of such units, and the establishment or 
        termination of such units, if the director of such 
        institute or center determines that the overall 
        management and operation of programs and activities 
        conducted or supported by such divisions, centers, or 
        other units would be more efficiently carried out under 
        such a reorganization.
    (e) Scientific Management Review Board for Periodic 
Organizational Reviews.--
            (1) In general.--Not later than 60 days after the 
        date of the enactment of the National Institutes of 
        Health Reform Act of 2006, the Secretary shall 
        establish an advisory council within the National 
        Institutes of Health to be known as the Scientific 
        Management Review Board (referred to in this subsection 
        as the ``Board'').
            (2) Duties.--
                    (A) Reports on organizational issues.--The 
                Board shall provide advice to the appropriate 
                officials under subsection (d) regarding the 
                use of the authorities established in 
                paragraphs (2), (3), and (4) of such subsection 
                to reorganize the National Institutes of Health 
                (referred to in this subsection as 
                ``organizational authorities''). Not less 
                frequently than once each 7 years, the Board 
                shall--
                            (i) determine whether and to what 
                        extent the organizational authorities 
                        should be used; and
                            (ii) issue a report providing the 
                        recommendations of the Board regarding 
                        the use of the authorities and the 
                        reasons underlying the recommendations.
                    (B) Certain responsibilities regarding 
                reports.--The activities of the Board with 
                respect to a report under subparagraph (A) 
                shall include the following:
                            (i) Reviewing the research 
                        portfolio of the National Institutes of 
                        Health (referred to in this subsection 
                        as ``NIH'') in order to determine the 
                        progress and effectiveness and value of 
                        the portfolio and the allocation among 
                        the portfolio activities of the 
                        resources of NIH.
                            (ii) Determining pending scientific 
                        opportunities, and public health needs, 
                        with respect to research within the 
                        jurisdiction of NIH.
                            (iii) For any proposal for 
                        organizational changes to which the 
                        Board gives significant consideration 
                        as a possible recommendation in such 
                        report--
                                    (I) analyzing the budgetary 
                                and operational consequences of 
                                the proposed changes;
                                    (II) taking into account 
                                historical funding and support 
                                for research activities at 
                                national research institutes 
                                and centers that have been 
                                established recently relative 
                                to national research institutes 
                                and centers that have been in 
                                existence for more than two 
                                decades;
                                    (III) estimating the level 
                                of resources needed to 
                                implement the proposed changes;
                                    (IV) assuming the proposed 
                                changes will be made and making 
                                a recommendation for the 
                                allocation of the resources of 
                                NIH among the national research 
                                institutes and national 
                                centers; and
                                    (V) analyzing the 
                                consequences for the progress 
                                of research in the areas 
                                affected by the proposed 
                                changes.
                    (C) Consultation.--In carrying out 
                subparagraph (A), the Board shall consult 
                with--
                            (i) the heads of national research 
                        institutes and national centers whose 
                        directors are not members of the Board;
                            (ii) other scientific leaders who 
                        are officers or employees of NIH and 
                        are not members of the Board;
                            (iii) advisory councils of the 
                        national research institutes and 
                        national centers;
                            (iv) organizations representing the 
                        scientific community; and
                            (v) organizations representing 
                        patients.
            (3) Composition of board.--The Board shall consist 
        of the Director of NIH, who shall be a permanent 
        nonvoting member on an ex officio basis, and an odd 
        number of additional members, not to exceed 21, all of 
        whom shall be voting members. The voting members of the 
        Board shall be the following:
                    (A) Not fewer than 9 officials who are 
                directors of national research institutes or 
                national centers. The Secretary shall designate 
                such officials for membership and shall ensure 
                that the group of officials so designated 
                includes directors of--
                            (i) national research institutes 
                        whose budgets are substantial relative 
                        to a majority of the other institutes;
                            (ii) national research institutes 
                        whose budgets are small relative to a 
                        majority of the other institutes;
                            (iii) national research institutes 
                        that have been in existence for a 
                        substantial period of time without 
                        significant organizational change under 
                        subsection (d);
                            (iv) as applicable, national 
                        research institutes that have undergone 
                        significant organization changes under 
                        such subsection, or that have been 
                        established under such subsection, 
                        other than national research institutes 
                        for which such changes have been in 
                        place for a substantial period of time; 
                        and
                            (v) national centers.
                    (B) Members appointed by the Secretary from 
                among individuals who are not officers or 
                employees of the United States. Such members 
                shall include--
                            (i) individuals representing the 
                        interests of public or private 
                        institutions of higher education that 
                        have historically received funds from 
                        NIH to conduct research; and
                            (ii) individuals representing the 
                        interests of private entities that have 
                        received funds from NIH to conduct 
                        research or that have broad expertise 
                        regarding how the National Institutes 
                        of Health functions, exclusive of 
                        private entities to which clause (i) 
                        applies.
            (4) Chair.--The Chair of the Board shall be 
        selected by the Secretary from among the members of the 
        Board appointed under paragraph (3)(B). The term of 
        office of the Chair shall be 2 years.
            (5) Meetings.--
                    (A) In general.--The Board shall meet at 
                the call of the Chair or upon the request of 
                the Director of NIH, but not fewer than 5 times 
                with respect to issuing any particular report 
                under paragraph (2)(A). The location of the 
                meetings of the Board is subject to the 
                approval of the Director of NIH.
                    (B) Particular forums.--Of the meetings 
                held under subparagraph (A) with respect to a 
                report under paragraph (2)(A)--
                            (i) one or more shall be directed 
                        toward the scientific community to 
                        address scientific needs and 
                        opportunities related to proposals for 
                        organizational changes under subsection 
                        (d), or as the case may be, related to 
                        a proposal that no such changes be 
                        made; and
                            (ii) one or more shall be directed 
                        toward consumer organizations to 
                        address the needs and opportunities of 
                        patients and their families with 
                        respect to proposals referred to in 
                        clause (i).
                    (C) Availability of information from 
                forums.--For each meeting under subparagraph 
                (B), the Director of NIH shall post on the 
                Internet site of the National Institutes of 
                Health a summary of the proceedings.
            (6) Compensation; term of office.--The provisions 
        of subsections (b)(4) and (c) of section 406 apply with 
        respect to the Board to the same extent and in the same 
        manner as such provisions apply with respect to an 
        advisory council referred to in such subsections, 
        except that the reference in such subsection (c) to 4 
        years regarding the term of an appointed member is 
        deemed to be a reference to 5 years.
            (7) Reports.--
                    (A) Recommendations for changes.--Each 
                report under paragraph (2)(A) shall be 
                submitted to--
                            (i) the Committee on Energy and 
                        Commerce and the Committee on 
                        Appropriations of the House of 
                        Representatives;
                            (ii) the Committee on Health, 
                        Education, Labor, and Pensions and the 
                        Committee on Appropriations of the 
                        Senate;
                            (iii) the Secretary; and
                            (iv) officials with organizational 
                        authorities, other than any such 
                        official who served as a member of the 
                        Board with respect to the report 
                        involved.
                    (B) Availability to public.--The Director 
                of NIH shall post each report under paragraph 
                (2) on the Internet site of the National 
                Institutes of Health.
                    (C) Report on board activities.--Not later 
                than 18 months after the date of the enactment 
                of the National Institutes of Health Reform Act 
                of 2006, the Board shall submit to the 
                committees specified in subparagraph (A) a 
                report describing the activities of the Board.
    (f) Organizational Changes per Recommendation of Scientific 
Management Review Board.--
            (1) In general.--With respect to an official who 
        has organizational authorities within the meaning of 
        subsection (e)(2)(A), if a recommendation to the 
        official for an organizational change is made in a 
        report under such subsection, the official shall, 
        except as provided in paragraphs (2), (3), and (4) of 
        this subsection, make the change in accordance with the 
        following:
                    (A) Not later than 100 days after the 
                report is submitted under subsection (e)(7)(A), 
                the official shall initiate the applicable 
                public process required in subsection (d) 
                toward making the change.
                    (B) The change shall be fully implemented 
                not later than the expiration of the 3-year 
                period beginning on the date on which such 
                process is initiated.
            (2) Inapplicability to certain reorganizations.--
        Paragraph (1) does not apply to a recommendation made 
        in a report under subsection (e)(2)(A) if the 
        recommendation is for--
                    (A) an organizational change under 
                subsection (d)(2) that constitutes the 
                establishment, termination, or consolidation of 
                one or more national research institutes or 
                national centers; or
                    (B) an organizational change under 
                subsection (d)(3).
            (3) Objection by director of nih.--
                    (A) In general.--Paragraph (1) does not 
                apply to a recommendation for an organizational 
                change made in a report under subsection 
                (e)(2)(A) if, not later than 90 days after the 
                report is submitted under subsection (e)(7)(A), 
                the Director of NIH submits to the committees 
                specified in such subsection a report providing 
                that the Director objects to the change, which 
                report includes the reasons underlying the 
                objection.
                    (B) Scope of objection.--For purposes of 
                subparagraph (A), an objection by the Director 
                of NIH may be made to the entirety of a 
                recommended organizational change or to 1 or 
                more aspects of the change. Any aspect of a 
                change not objected to by the Director in a 
                report under subparagraph (A) shall be 
                implemented in accordance with paragraph (1).
            (4) Congressional review.--An organizational change 
        under subsection (d)(2) that is initiated pursuant to 
        paragraph (1) shall be carried out by regulation in 
        accordance with the procedures for substantive rules 
        under section 553 of title 5, United States Code. A 
        rule under the preceding sentence shall be considered a 
        major rule for purposes of chapter 8 of such title 
        (relating to congressional review of agency 
        rulemaking).
    (g) Definitions.--For purposes of this title:
            (1) The term ``Director of NIH'' means the Director 
        of the National Institutes of Health.
            (2) The terms ``national research institute'' and 
        ``national center'' mean an agency of the National 
        Institutes of Health that is--
                    (A) listed in subsection (b) and not 
                terminated under subsection (d)(2)(A); or
                    (B) established by the Director of NIH 
                under such subsection.
    (h) References to NIH.--For purposes of this title, a 
reference to the National Institutes of Health includes its 
agencies.
              appointment and authority of director of nih
    Sec. 402. [282] (a) The National Institutes of Health shall 
be headed by the Director of NIH who shall be appointed by the 
President by and with the advice and consent of the Senate. The 
Director of NIH shall perform functions as provided under 
subsection (b) and as the Secretary may otherwise prescribe.
    (b) In carrying out the purposes of section 301, the 
Secretary, acting through the Director of NIH--
            (1) shall carry out this title, including being 
        responsible for the overall direction of the National 
        Institutes of Health and for the establishment and 
        implementation of general policies respecting the 
        management and operation of programs and activities 
        within the National Institutes of Health;
            (2) shall coordinate and oversee the operation of 
        the national research institutes, national centers, and 
        administrative entities within the National Institutes 
        of Health;
            (3) shall, in consultation with the heads of the 
        national research institutes and national centers, be 
        responsible for program coordination across the 
        national research institutes and national centers, 
        including conducting priority-setting reviews, to 
        ensure that the research portfolio of the National 
        Institutes of Health is balanced and free of 
        unnecessary duplication, and takes advantage of 
        collaborative, cross-cutting research;
            (4) shall assemble accurate data to be used to 
        assess research priorities, including information to 
        better evaluate scientific opportunity, public health 
        burdens, and progress in reducing minority and other 
        health disparities;
            (5) shall ensure that scientifically based 
        strategic planning is implemented in support of 
        research priorities as determined by the agencies of 
        the National Institutes of Health;
            (6) shall ensure that the resources of the National 
        Institutes of Health are sufficiently allocated for 
        research projects identified in strategic plans;
            (7)(A) shall, through the Division of Program 
        Coordination, Planning, and Strategic Initiatives--
                    (i) identify research that represents 
                important areas of emerging scientific 
                opportunities, rising public health challenges, 
                or knowledge gaps that deserve special emphasis 
                and would benefit from conducting or supporting 
                additional research that involves collaboration 
                between 2 or more national research institutes 
                or national centers, or would otherwise benefit 
                from strategic coordination and planning;
                    (ii) include information on such research 
                in reports under section 403; and
                    (iii) in the case of such research 
                supported with funds referred to in 
                subparagraph (B)--
                            (I) require as appropriate that 
                        proposals include milestones and goals 
                        for the research;
                            (II) require that the proposals 
                        include timeframes for funding of the 
                        research; and
                            (III) ensure appropriate 
                        consideration of proposals for which 
                        the principal investigator is an 
                        individual who has not previously 
                        served as the principal investigator of 
                        research conducted or supported by the 
                        National Institutes of Health;
            (B) may, with respect to funds reserved under 
        section 402A(c)(1) for the Common Fund, allocate such 
        funds to the national research institutes and national 
        centers for conducting and supporting research that is 
        identified under subparagraph (A); and
            (C) may assign additional functions to the Division 
        in support of responsibilities identified in 
        subparagraph (A), as determined appropriate by the 
        Director;
            (8) shall, in coordination with the heads of the 
        national research institutes and national centers, 
        ensure that such institutes and centers--
                    (A) preserve an emphasis on investigator-
                initiated research project grants, including 
                with respect to research involving 
                collaboration between 2 or more such institutes 
                or centers; and
                    (B) when appropriate, maximize 
                investigator-initiated research project grants 
                in their annual research portfolios;
            (9) shall ensure that research conducted or 
        supported by the National Institutes of Health is 
        subject to review in accordance with section 492 and 
        that, after such review, the research is reviewed in 
        accordance with section 492A(a)(2) by the appropriate 
        advisory council under section 406 before the research 
        proposals are approved for funding;
            (10) shall have authority to review and approve the 
        establishment of all centers of excellence recommended 
        by the national research institutes;
            (11)(A) shall oversee research training for all of 
        the national research institutes and National Research 
        Service Awards in accordance with section 487; and
            (B) may conduct and support research training--
                    (i) for which fellowship support is not 
                provided under section 487; and
                    (ii) that does not consist of residency 
                training of physicians or other health 
                professionals;
            (12) may, from funds appropriated under section 
        402A(b), reserve funds to provide for research on 
        matters that have not received significant funding 
        relative to other matters, to respond to new issues and 
        scientific emergencies, and to act on research 
        opportunities of high priority;
            (13) may, subject to appropriations Acts, collect 
        and retain registration fees obtained from third 
        parties to defray expenses for scientific, educational, 
        and research-related conferences;
            (14) for the national research institutes and 
        administrative entities within the National Institutes 
        of Health--
                    (A) may acquire, construct, improve, 
                repair, operate, and maintain, at the site of 
                such institutes and entities, laboratories, and 
                other research facilities, other facilities, 
                equipment, and other real or personal property, 
                and
                    (B) may acquire, without regard to the Act 
                of March 3, 1877 (40 U.S.C. 34), by lease or 
                otherwise through the Administrator of General 
                Services, buildings or parts of buildings in 
                the District of Columbia or communities located 
                adjacent to the District of Columbia for use 
                for a period not to exceed ten years;
            (15) may secure resources for research conducted by 
        or through the National Institutes of Health;
            (16) may, without regard to the provisions of title 
        5, United States Code, governing appointments in the 
        competitive service, and without regard to the 
        provisions of chapter 51 and subchapter III of chapter 
        53 of such title relating to classification and General 
        Schedule pay rates, establish such technical and 
        scientific peer review groups and scientific program 
        advisory committees as are needed to carry out the 
        requirements of this title and appoint and pay the 
        members of such groups, except that officers and 
        employees of the United States shall not receive 
        additional compensation for service as members of such 
        groups;
            (17) may secure for the National Institutes of 
        Health consultation services and advice of persons from 
        the United States or abroad;
            (18) may use, with their consent, the services, 
        equipment, personnel, information, and facilities of 
        other Federal, State, or local public agencies, with or 
        without reimbursement therefor;
            (19) may, for purposes of study, admit and treat at 
        facilities of the National Institutes of Health 
        individuals not otherwise eligible for such treatment;
            (20) may accept voluntary and uncompensated 
        services;
            (21) may perform such other administrative 
        functions as the Secretary determines are needed to 
        effectively carry out this title;
            (22) may appoint physicians, dentists, and other 
        health care professionals, subject to the provisions of 
        title 5, United States Code, relating to appointments 
        and classifications in the competitive service, and may 
        compensate such professionals subject to the provisions 
        of chapter 74 of title 38, United States Code;
            (23) shall designate a contact point or office to 
        help innovators and physicians identify sources of 
        funding available for pediatric medical device 
        development; and
            (24) implement the Cures Acceleration Network 
        described in section 402C.
The Federal Advisory Committee Act shall not apply to the 
duration of a peer review group appointed under paragraph (16). 
The members of such a group shall be individuals who by virtue 
of their training or experience are eminently qualified to 
perform the review functions of such group. Not more than one-
fourth of the members of any such group shall be officers or 
employees of the United States.
    (c) The Director of NIH may make available to individuals 
and entities, for biomedical and behavioral research, 
substances and living organisms. Such substances and organisms 
shall be made available under such terms and conditions 
(including payment for them) as the Secretary determines 
appropriate.
    (d)(1) The Director of NIH may obtain (in accordance with 
section 3109 of title 5, United States Code, but without regard 
to the limitation in such section on the period of service) the 
services of not more than 220 experts or consultants, with 
scientific or other professional qualifications, for the 
National Institutes of Health.
    (2)(A) Except as provided in subparagraph (B), experts and 
consultants whose services are obtained under paragraph (1) 
shall be paid or reimbursed, in accordance with title 5, United 
States Code, for their travel to and from their place of 
service and for other expenses associated with their 
assignment.
    (B) Expenses specified in subparagraph (A) shall not be 
allowed in connection with the assignment of an expert or 
consultant whose services are obtained under paragraph (1) 
unless the expert or consultant has agreed in writing to 
complete the entire period of the assignment or one year of the 
assignment, whichever is shorter, unless separated or 
reassigned for reasons which are beyond the control of the 
expert or consultant and which are acceptable to the Secretary. 
If the expert or consultant violates the agreement, the money 
spent by the United States for such expenses is recoverable 
from the expert or consultant as a debt due the United States. 
The Secretary may waive in whole or in part a right of recovery 
under this subparagraph.
    (e) The Director of NIH shall--
            (1) advise the agencies of the National Institutes 
        of Health on medical applications of research;
            (2) coordinate, review, and facilitate the 
        systematic identification and evaluation of, clinically 
        relevant information from research conducted by or 
        through the national research institutes;
            (3) promote the effective transfer of the 
        information described in paragraph (2) to the health 
        care community and to entities that require such 
        information;
            (4) monitor the effectiveness of the activities 
        described in paragraph (3); and
            (5) ensure that, after January 1, 1994, all new or 
        revised health education and promotion materials 
        developed or funded by the National Institutes of 
        Health and intended for the general public are in a 
        form that does not exceed a level of functional 
        literacy, as defined in the National Literacy Act of 
        1991 (Public Law 102-73) \1\.
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    \1\ So in law. That Act was repealed by section 251(a)(2) of Public 
Law 105-220 (112 Stat. 1079).
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    (f) There shall be in the National Institutes of Health an 
Associate Director for Prevention. The Director of NIH shall 
delegate to the Associate Director for Prevention the functions 
of the Director relating to the promotion of the disease 
prevention research programs of the national research 
institutes and the coordination of such programs among the 
national research institutes and between the national research 
institutes and other public and private entities, including 
elementary, secondary, and post-secondary schools. The 
Associate Director shall--
            (1) annually review the efficacy of existing 
        policies and techniques used by the national research 
        institutes to disseminate the results of disease 
        prevention and behavioral research programs; and
            (2) recommend, coordinate, and oversee the 
        modification or reconstruction of such policies and 
        techniques to ensure maximum dissemination, using 
        advanced technologies to the maximum extent 
        practicable, of research results to such entities.
    (g)(1)(A) In the case of entities described in subparagraph 
(B), the Director of NIH, acting through the Director of the 
National Center for Research Resources, shall establish a 
program to enhance the competitiveness of such entities in 
obtaining funds from the national research institutes for 
conducting biomedical and behavioral research.
    (B) The entities referred to in subparagraph (A) are 
entities that conduct biomedical and behavioral research and 
are located in a State in which the aggregate success rate for 
applications to the national research institutes for assistance 
for such research by the entities in the State has historically 
constituted a low success rate of obtaining such funds, 
relative to such aggregate rate for such entities in other 
States.
    (C) With respect to enhancing competitiveness for purposes 
of subparagraph (A), the Director of NIH, in carrying out the 
program established under such subparagraph, may--
            (i) provide technical assistance to the entities 
        involved, including technical assistance in the 
        preparation of applications for obtaining funds from 
        the national research institutes;
            (ii) assist the entities in developing a plan for 
        biomedical or behavioral research proposals; and
            (iii) assist the entities in implementing such 
        plan.
    (2) The Director of NIH shall establish a program of 
supporting projects of biomedical or behavioral research whose 
principal researchers are individuals who have not previously 
served as the principal researchers of such projects supported 
by the Director.
    (h) The Secretary, acting through the Director of NIH and 
the Directors of the agencies of the National Institutes of 
Health, shall, in conducting and supporting programs for 
research, research training, recruitment, and other activities, 
provide for an increase in the number of women and individuals 
from disadvantaged backgrounds (including racial and ethnic 
minorities) in the fields of biomedical and behavioral 
research.
    (i)(1)(A) The Secretary, acting through the Director of 
NIH, shall establish, maintain, and operate a data bank of 
information on clinical trials for drugs for serious or life-
threatening diseases and conditions (in this subsection 
referred to as the ``data bank''). The activities of the data 
bank shall be integrated and coordinated with related 
activities of other agencies of the Department of Health and 
Human Services, and to the extent practicable, coordinated with 
other data banks containing similar information.
    (B) The Secretary shall establish the data bank after 
consultation with the Commissioner of Food and Drugs, the 
directors of the appropriate agencies of the National 
Institutes of Health (including the National Library of 
Medicine), and the Director of the Centers for Disease Control 
and Prevention.
    (2) In carrying out paragraph (1), the Secretary shall 
collect, catalog, store, and disseminate the information 
described in such paragraph. The Secretary shall disseminate 
such information through information systems, which shall 
include toll-free telephone communications, available to 
individuals with serious or life-threatening diseases and 
conditions, to other members of the public, to health care 
providers, and to researchers.
    (3) The data bank shall include the following:
            (A) A registry of clinical trials (whether 
        federally or privately funded) of experimental 
        treatments for serious or life-threatening diseases and 
        conditions under regulations promulgated pursuant to 
        section 505(i) of the Federal Food, Drug, and Cosmetic 
        Act, which provides a description of the purpose of 
        each experimental drug, either with the consent of the 
        protocol sponsor, or when a trial to test effectiveness 
        begins. Information provided shall consist of 
        eligibility criteria for participation in the clinical 
        trials, a description of the location of trial sites, 
        and a point of contact for those wanting to enroll in 
        the trial, and shall be in a form that can be readily 
        understood by members of the public. \1\ Such 
        information shall be forwarded to the data bank by the 
        sponsor of the trial not later than 21 days after the 
        approval of the protocol.
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    \1\ Section 15(c)(2) of Public Law 107-109 (115 Stat. 1420) 
attempted to make amendments to the first sentence of subparagraph (A), 
but the amendments cannot be executed because the terms to be amended 
appear in the second sentence, not the first. The following shows the 
second sentence as it would appear if the amendments were executed to 
the second sentence: ``Information provided shall consist of 
eligibility criteria for participation in the clinical trials, a 
description of the location of trial sites, a point of contact for 
those wanting to enroll in the trial, and a description of whether, and 
through what procedure, the manufacturer or sponsor of the 
investigation of a new drug will respond to requests for protocol 
exception, with appropriate safeguards, for single-patient and expanded 
protocol use of the new drug, particularly in children, and shall be in 
a form that can be readily understood by members of the public.''.
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            (B) Information pertaining to experimental 
        treatments for serious or life-threatening diseases and 
        conditions that may be available--
                    (i) under a treatment investigational new 
                drug application that has been submitted to the 
                Secretary under section 561(c) of the Federal 
                Food, Drug, and Cosmetic Act; or
                    (ii) as a Group C cancer drug (as defined 
                by the National Cancer Institute).
        The data bank may also include information pertaining 
        to the results of clinical trials of such treatments, 
        with the consent of the sponsor, including information 
        concerning potential toxicities or adverse effects 
        associated with the use or administration of such 
        experimental treatments.
    (4) The data bank shall not include information relating to 
an investigation if the sponsor has provided a detailed 
certification to the Secretary that disclosure of such 
information would substantially interfere with the timely 
enrollment of subjects in the investigation, unless the 
Secretary, after the receipt of the certification, provides the 
sponsor with a detailed written determination that such 
disclosure would not substantially interfere with such 
enrollment.
    (5) Fees collected under section 736 of the Federal Food, 
Drug, and Cosmetic Act shall not be used in carrying out this 
subsection.
    (j) Expanded Clinical Trial Registry Data Bank.--
            (1) Definitions; requirement.--
                    (A) Definitions.--In this subsection:
                            (i) Applicable clinical trial.--The 
                        term ``applicable clinical trial'' 
                        means an applicable device clinical 
                        trial or an applicable drug clinical 
                        trial.
                            (ii) Applicable device clinical 
                        trial.--The term ``applicable device 
                        clinical trial'' means--
                                    (I) a prospective clinical 
                                study of health outcomes 
                                comparing an intervention with 
                                a device subject to section 
                                510(k), 515, or 520(m) of the 
                                Federal Food, Drug, and 
                                Cosmetic Act against a control 
                                in human subjects (other than a 
                                small clinical trial to 
                                determine the feasibility of a 
                                device, or a clinical trial to 
                                test prototype devices where 
                                the primary outcome measure 
                                relates to feasibility and not 
                                to health outcomes); and
                                    (II) a pediatric postmarket 
                                surveillance as required under 
                                section 522 of the Federal 
                                Food, Drug, and Cosmetic Act.
                            (iii) Applicable drug clinical 
                        trial.--
                                    (I) In general.--The term 
                                ``applicable drug clinical 
                                trial'' means a controlled 
                                clinical investigation, other 
                                than a phase I clinical 
                                investigation, of a drug 
                                subject to section 505 of the 
                                Federal Food, Drug, and 
                                Cosmetic Act or to section 351 
                                of this Act.
                                    (II) Clinical 
                                investigation.--For purposes of 
                                subclause (I), the term 
                                ``clinical investigation'' has 
                                the meaning given that term in 
                                section 312.3 of title 21, Code 
                                of Federal Regulations (or any 
                                successor regulation).
                                    (III) Phase i.--For 
                                purposes of subclause (I), the 
                                term ``phase I'' has the 
                                meaning given that term in 
                                section 312.21 of title 21, 
                                Code of Federal Regulations (or 
                                any successor regulation).
                            (iv) Clinical trial information.--
                        The term ``clinical trial information'' 
                        means, with respect to an applicable 
                        clinical trial, those data elements 
                        that the responsible party is required 
                        to submit under paragraph (2) or under 
                        paragraph (3).
                            (v) Completion date.--The term 
                        ``completion date'' means, with respect 
                        to an applicable clinical trial, the 
                        date that the final subject was 
                        examined or received an intervention 
                        for the purposes of final collection of 
                        data for the primary outcome, whether 
                        the clinical trial concluded according 
                        to the prespecified protocol or was 
                        terminated.
                            (vi) Device.--The term ``device'' 
                        means a device as defined in section 
                        201(h) of the Federal Food, Drug, and 
                        Cosmetic Act.
                            (vii) Drug.--The term ``drug'' 
                        means a drug as defined in section 
                        201(g) of the Federal Food, Drug, and 
                        Cosmetic Act or a biological product as 
                        defined in section 351 of this Act.
                            (viii) Ongoing.--The term 
                        ``ongoing'' means, with respect to a 
                        clinical trial of a drug or a device 
                        and to a date, that--
                                    (I) 1 or more patients is 
                                enrolled in the clinical trial; 
                                and
                                    (II) the date is before the 
                                completion date of the clinical 
                                trial.
                            (ix) Responsible party.--The term 
                        ``responsible party'', with respect to 
                        a clinical trial of a drug or device, 
                        means--
                                    (I) the sponsor of the 
                                clinical trial (as defined in 
                                section 50.3 of title 21, Code 
                                of Federal Regulations (or any 
                                successor regulation)); or
                                    (II) the principal 
                                investigator of such clinical 
                                trial if so designated by a 
                                sponsor, grantee, contractor, 
                                or awardee, so long as the 
                                principal investigator is 
                                responsible for conducting the 
                                trial, has access to and 
                                control over the data from the 
                                clinical trial, has the right 
                                to publish the results of the 
                                trial, and has the ability to 
                                meet all of the requirements 
                                under this subsection for the 
                                submission of clinical trial 
                                information.
                    (B) Requirement.--The Secretary shall 
                develop a mechanism by which the responsible 
                party for each applicable clinical trial shall 
                submit the identity and contact information of 
                such responsible party to the Secretary at the 
                time of submission of clinical trial 
                information under paragraph (2).
            (2) Expansion of clinical trial registry data bank 
        with respect to clinical trial information.--
                    (A) In general.--
                            (i) Expansion of data bank.--To 
                        enhance patient enrollment and provide 
                        a mechanism to track subsequent 
                        progress of clinical trials, the 
                        Secretary, acting through the Director 
                        of NIH, shall expand, in accordance 
                        with this subsection, the clinical 
                        trials registry of the data bank 
                        described under subsection (i)(1) 
                        (referred to in this subsection as the 
                        ``registry data bank''). The Director 
                        of NIH shall ensure that the registry 
                        data bank is made publicly available 
                        through the Internet.
                            (ii) Content.--The clinical trial 
                        information required to be submitted 
                        under this paragraph for an applicable 
                        clinical trial shall include--
                                    (I) descriptive 
                                information, including--
                                            (aa) a brief title, 
                                        intended for the lay 
                                        public;
                                            (bb) a brief 
                                        summary, intended for 
                                        the lay public;
                                            (cc) the primary 
                                        purpose;
                                            (dd) the study 
                                        design;
                                            (ee) for an 
                                        applicable drug 
                                        clinical trial, the 
                                        study phase;
                                            (ff) study type;
                                            (gg) the primary 
                                        disease or condition 
                                        being studied, or the 
                                        focus of the study;
                                            (hh) the 
                                        intervention name and 
                                        intervention type;
                                            (ii) the study 
                                        start date;
                                            (jj) the expected 
                                        completion date;
                                            (kk) the target 
                                        number of subjects; and
                                            (ll) outcomes, 
                                        including primary and 
                                        secondary outcome 
                                        measures;
                                    (II) recruitment 
                                information, including--
                                            (aa) eligibility 
                                        criteria;
                                            (bb) gender;
                                            (cc) age limits;
                                            (dd) whether the 
                                        trial accepts healthy 
                                        volunteers;
                                            (ee) overall 
                                        recruitment status;
                                            (ff) individual 
                                        site status; and
                                            (gg) in the case of 
                                        an applicable drug 
                                        clinical trial, if the 
                                        drug is not approved 
                                        under section 505 of 
                                        the Federal Food, Drug, 
                                        and Cosmetic Act or 
                                        licensed under section 
                                        351 of this Act, 
                                        specify whether or not 
                                        there is expanded 
                                        access to the drug 
                                        under section 561 of 
                                        the Federal Food, Drug, 
                                        and Cosmetic Act for 
                                        those who do not 
                                        qualify for enrollment 
                                        in the clinical trial 
                                        and how to obtain 
                                        information about such 
                                        access;
                                    (III) location and contact 
                                information, including--
                                            (aa) the name of 
                                        the sponsor;
                                            (bb) the 
                                        responsible party, by 
                                        official title; and
                                            (cc) the facility 
                                        name and facility 
                                        contact information 
                                        (including the city, 
                                        State, and zip code for 
                                        each clinical trial 
                                        location, or a toll-
                                        free number through 
                                        which such location 
                                        information may be 
                                        accessed); and
                                    (IV) administrative data 
                                (which the Secretary may make 
                                publicly available as 
                                necessary), including--
                                            (aa) the unique 
                                        protocol identification 
                                        number;
                                            (bb) other protocol 
                                        identification numbers, 
                                        if any; and
                                            (cc) the Food and 
                                        Drug Administration 
                                        IND/IDE protocol number 
                                        and the record 
                                        verification date.
                            (iii) Modifications.--The Secretary 
                        may by regulation modify the 
                        requirements for clinical trial 
                        information under this paragraph, if 
                        the Secretary provides a rationale for 
                        why such a modification improves and 
                        does not reduce such clinical trial 
                        information.
                    (B) Format and structure.--
                            (i) Searchable categories.--The 
                        Director of NIH shall ensure that the 
                        public may, in addition to keyword 
                        searching, search the entries in the 
                        registry data bank by 1 or more of the 
                        following criteria:
                                    (I) The disease or 
                                condition being studied in the 
                                clinical trial, using Medical 
                                Subject Headers (MeSH) 
                                descriptors.
                                    (II) The name of the 
                                intervention, including any 
                                drug or device being studied in 
                                the clinical trial.
                                    (III) The location of the 
                                clinical trial.
                                    (IV) The age group studied 
                                in the clinical trial, 
                                including pediatric 
                                subpopulations.
                                    (V) The study phase of the 
                                clinical trial.
                                    (VI) The sponsor of the 
                                clinical trial, which may be 
                                the National Institutes of 
                                Health or another Federal 
                                agency, a private industry 
                                source, or a university or 
                                other organization.
                                    (VII) The recruitment 
                                status of the clinical trial.
                                    (VIII) The National 
                                Clinical Trial number or other 
                                study identification for the 
                                clinical trial.
                            (ii) Additional searchable 
                        category.--Not later than 18 months 
                        after the date of the enactment of the 
                        Food and Drug Administration Amendments 
                        Act of 2007, the Director of NIH shall 
                        ensure that the public may search the 
                        entries of the registry data bank by 
                        the safety issue, if any, being studied 
                        in the clinical trial as a primary or 
                        secondary outcome.
                            (iii) Other elements.--The Director 
                        of NIH shall also ensure that the 
                        public may search the entries of the 
                        registry data bank by such other 
                        elements as the Director deems 
                        necessary on an ongoing basis.
                            (iv) Format.--The Director of the 
                        NIH shall ensure that the registry data 
                        bank is easily used by the public, and 
                        that entries are easily compared.
                    (C) Data submission.--The responsible party 
                for an applicable clinical trial, including an 
                applicable drug clinical trial for a serious or 
                life-threatening disease or condition, that is 
                initiated after, or is ongoing on the date that 
                is 90 days after, the date of the enactment of 
                the Food and Drug Administration Amendments Act 
                of 2007, shall submit to the Director of NIH 
                for inclusion in the registry data bank the 
                clinical trial information described in of 
                subparagraph (A)(ii) not later than the later 
                of--
                            (i) 90 days after such date of 
                        enactment;
                            (ii) 21 days after the first 
                        patient is enrolled in such clinical 
                        trial; or
                            (iii) in the case of a clinical 
                        trial that is not for a serious or 
                        life-threatening disease or condition 
                        and that is ongoing on such date of 
                        enactment, 1 year after such date of 
                        enactment.
                    (D) Posting of data.--
                            (i) Applicable drug clinical 
                        trial.--The Director of NIH shall 
                        ensure that clinical trial information 
                        for an applicable drug clinical trial 
                        submitted in accordance with this 
                        paragraph is posted in the registry 
                        data bank not later than 30 days after 
                        such submission.
                            (ii) Applicable device clinical 
                        trial.--The Director of NIH shall 
                        ensure that clinical trial information 
                        for an applicable device clinical trial 
                        submitted in accordance with this 
                        paragraph is posted publicly in the 
                        registry data bank--
                                    (I) not earlier than the 
                                date of clearance under section 
                                510(k) of the Federal Food, 
                                Drug, and Cosmetic Act, or 
                                approval under section 515 or 
                                520(m) of such Act, as 
                                applicable, for a device that 
                                was not previously cleared or 
                                approved, and not later than 30 
                                days after such date; or
                                    (II) for a device that was 
                                previously cleared or approved, 
                                not later than 30 days after 
                                the clinical trial information 
                                under paragraph (3)(C) is 
                                required to be posted by the 
                                Secretary.
            (3) Expansion of registry data bank to include 
        results of clinical trials.--
                    (A) Linking registry data bank to existing 
                results.--
                            (i) In general.--Beginning not 
                        later than 90 days after the date of 
                        the enactment of the Food and Drug 
                        Administration Amendments Act of 2007, 
                        for those clinical trials that form the 
                        primary basis of an efficacy claim or 
                        are conducted after the drug involved 
                        is approved or after the device 
                        involved is cleared or approved, the 
                        Secretary shall ensure that the 
                        registry data bank includes links to 
                        results information as described in 
                        clause (ii) for such clinical trial--
                                    (I) not earlier than 30 
                                days after the date of the 
                                approval of the drug involved 
                                or clearance or approval of the 
                                device involved; or
                                    (II) not later than 30 days 
                                after the results information 
                                described in clause (ii) 
                                becomes publicly available.
                            (ii) Required information.--
                                    (I) FDA information.--The 
                                Secretary shall ensure that the 
                                registry data bank includes 
                                links to the following 
                                information:
                                            (aa) If an advisory 
                                        committee considered at 
                                        a meeting an applicable 
                                        clinical trial, any 
                                        posted Food and Drug 
                                        Administration summary 
                                        document regarding such 
                                        applicable clinical 
                                        trial.
                                            (bb) If an 
                                        applicable drug 
                                        clinical trial was 
                                        conducted under section 
                                        505A or 505B of the 
                                        Federal Food, Drug, and 
                                        Cosmetic Act, a link to 
                                        the posted Food and 
                                        Drug Administration 
                                        assessment of the 
                                        results of such trial.
                                            (cc) Food and Drug 
                                        Administration public 
                                        health advisories 
                                        regarding the drug or 
                                        device that is the 
                                        subject of the 
                                        applicable clinical 
                                        trial, if any.
                                            (dd) For an 
                                        applicable drug 
                                        clinical trial, the 
                                        Food and Drug 
                                        Administration action 
                                        package for approval 
                                        document required under 
                                        section 505(l)(2) of 
                                        the Federal Food, Drug, 
                                        and Cosmetic Act.
                                            (ee) For an 
                                        applicable device 
                                        clinical trial, in the 
                                        case of a premarket 
                                        application under 
                                        section 515 of the 
                                        Federal Food, Drug, and 
                                        Cosmetic Act, the 
                                        detailed summary of 
                                        information respecting 
                                        the safety and 
                                        effectiveness of the 
                                        device required under 
                                        section 520(h)(1) of 
                                        such Act, or, in the 
                                        case of a report under 
                                        section 510(k) of such 
                                        Act, the section 510(k) 
                                        summary of the safety 
                                        and effectiveness data 
                                        required under section 
                                        807.95(d) of title 21, 
                                        Code of Federal 
                                        Regulations (or any 
                                        successor regulation).
                                    (II) NIH information.--The 
                                Secretary shall ensure that the 
                                registry data bank includes 
                                links to the following 
                                information:
                                            (aa) Medline 
                                        citations to any 
                                        publications focused on 
                                        the results of an 
                                        applicable clinical 
                                        trial.
                                            (bb) The entry for 
                                        the drug that is the 
                                        subject of an 
                                        applicable drug 
                                        clinical trial in the 
                                        National Library of 
                                        Medicine database of 
                                        structured product 
                                        labels, if available.
                            (iii) Results for existing data 
                        bank entries.--The Secretary may 
                        include the links described in clause 
                        (ii) for data bank entries for clinical 
                        trials submitted to the data bank prior 
                        to enactment of the Food and Drug 
                        Administration Amendments Act of 2007, 
                        as available.
                    (B) Inclusion of results.--The Secretary, 
                acting through the Director of NIH, shall--
                            (i) expand the registry data bank 
                        to include the results of applicable 
                        clinical trials (referred to in this 
                        subsection as the ``registry and 
                        results data bank'');
                            (ii) ensure that such results are 
                        made publicly available through the 
                        Internet;
                            (iii) post publicly a glossary for 
                        the lay public explaining technical 
                        terms related to the results of 
                        clinical trials; and
                            (iv) in consultation with experts 
                        on risk communication, provide 
                        information with the information 
                        included under subparagraph (C) in the 
                        registry and results data bank to help 
                        ensure that such information does not 
                        mislead the patients or the public.
                    (C) Basic results.--Not later than 1 year 
                after the date of the enactment of the Food and 
                Drug Administration Amendments Act of 2007, the 
                Secretary shall include in the registry and 
                results data bank for each applicable clinical 
                trial for a drug that is approved under section 
                505 of the Federal Food, Drug, and Cosmetic Act 
                or licensed under section 351 of this Act or a 
                device that is cleared under section 510(k) of 
                the Federal Food, Drug, and Cosmetic Act or 
                approved under section 515 or 520(m) of such 
                Act, the following elements:
                            (i) Demographic and baseline 
                        characteristics of patient sample.--A 
                        table of the demographic and baseline 
                        data collected overall and for each arm 
                        of the clinical trial to describe the 
                        patients who participated in the 
                        clinical trial, including the number of 
                        patients who dropped out of the 
                        clinical trial and the number of 
                        patients excluded from the analysis, if 
                        any.
                            (ii) Primary and secondary 
                        outcomes.--The primary and secondary 
                        outcome measures as submitted under 
                        paragraph (2)(A)(ii)(I)(ll), and a 
                        table of values for each of the primary 
                        and secondary outcome measures for each 
                        arm of the clinical trial, including 
                        the results of scientifically 
                        appropriate tests of the statistical 
                        significance of such outcome measures.
                            (iii) Point of contact.--A point of 
                        contact for scientific information 
                        about the clinical trial results.
                            (iv) Certain agreements.--Whether 
                        there exists an agreement (other than 
                        an agreement solely to comply with 
                        applicable provisions of law protecting 
                        the privacy of participants) between 
                        the sponsor or its agent and the 
                        principal investigator (unless the 
                        sponsor is an employer of the principal 
                        investigator) that restricts in any 
                        manner the ability of the principal 
                        investigator, after the completion date 
                        of the trial, to discuss the results of 
                        the trial at a scientific meeting or 
                        any other public or private forum, or 
                        to publish in a scientific or academic 
                        journal information concerning the 
                        results of the trial.
                    (D) Expanded registry and results data 
                bank.--
                            (i) Expansion by rulemaking.--To 
                        provide more complete results 
                        information and to enhance patient 
                        access to and understanding of the 
                        results of clinical trials, not later 
                        than 3 years after the date of the 
                        enactment of the Food and Drug 
                        Administration Amendments Act of 2007, 
                        the Secretary shall by regulation 
                        expand the registry and results data 
                        bank as provided under this 
                        subparagraph.
                            (ii) Clinical trials.--
                                    (I) Approved products.--The 
                                regulations under this 
                                subparagraph shall require the 
                                inclusion of the results 
                                information described in clause 
                                (iii) for--
                                            (aa) each 
                                        applicable drug 
                                        clinical trial for a 
                                        drug that is approved 
                                        under section 505 of 
                                        the Federal Food, Drug, 
                                        and Cosmetic Act or 
                                        licensed under section 
                                        351 of this Act; and
                                            (bb) each 
                                        applicable device 
                                        clinical trial for a 
                                        device that is cleared 
                                        under section 510(k) of 
                                        the Federal Food, Drug, 
                                        and Cosmetic Act or 
                                        approved under section 
                                        515 or 520(m) of such 
                                        Act.
                                    (II) Unapproved products.--
                                The regulations under this 
                                subparagraph shall establish 
                                whether or not the results 
                                information described in clause 
                                (iii) shall be required for--
                                            (aa) an applicable 
                                        drug clinical trial for 
                                        a drug that is not 
                                        approved under section 
                                        505 of the Federal 
                                        Food, Drug, and 
                                        Cosmetic Act and not 
                                        licensed under section 
                                        351 of this Act 
                                        (whether approval or 
                                        licensure was sought or 
                                        not); and
                                            (bb) an applicable 
                                        device clinical trial 
                                        for a device that is 
                                        not cleared under 
                                        section 510(k) of the 
                                        Federal Food, Drug, and 
                                        Cosmetic Act and not 
                                        approved under section 
                                        515 or section 520(m) 
                                        of such Act (whether 
                                        clearance or approval 
                                        was sought or not).
                            (iii) Required elements.--The 
                        regulations under this subparagraph 
                        shall require, in addition to the 
                        elements described in subparagraph (C), 
                        information within each of the 
                        following categories:
                                    (I) A summary of the 
                                clinical trial and its results 
                                that is written in non-
                                technical, understandable 
                                language for patients, if the 
                                Secretary determines that such 
                                types of summary can be 
                                included without being 
                                misleading or promotional.
                                    (II) A summary of the 
                                clinical trial and its results 
                                that is technical in nature, if 
                                the Secretary determines that 
                                such types of summary can be 
                                included without being 
                                misleading or promotional.
                                    (III) The full protocol or 
                                such information on the 
                                protocol for the trial as may 
                                be necessary to help to 
                                evaluate the results of the 
                                trial.
                                    (IV) Such other categories 
                                as the Secretary determines 
                                appropriate.
                            (iv) Results submission.--The 
                        results information described in clause 
                        (iii) shall be submitted to the 
                        Director of NIH for inclusion in the 
                        registry and results data bank as 
                        provided by subparagraph (E), except 
                        that the Secretary shall by regulation 
                        determine--
                                    (I) whether the 1-year 
                                period for submission of 
                                clinical trial information 
                                described in subparagraph 
                                (E)(i) should be increased from 
                                1 year to a period not to 
                                exceed 18 months;
                                    (II) whether the clinical 
                                trial information described in 
                                clause (iii) should be required 
                                to be submitted for an 
                                applicable clinical trial for 
                                which the clinical trial 
                                information described in 
                                subparagraph (C) is submitted 
                                to the registry and results 
                                data bank before the effective 
                                date of the regulations issued 
                                under this subparagraph; and
                                    (III) in the case when the 
                                clinical trial information 
                                described in clause (iii) is 
                                required to be submitted for 
                                the applicable clinical trials 
                                described in clause (ii)(II), 
                                the date by which such clinical 
                                trial information shall be 
                                required to be submitted, 
                                taking into account--
                                            (aa) the 
                                        certification process 
                                        under subparagraph 
                                        (E)(iii) when approval, 
                                        licensure, or clearance 
                                        is sought; and
                                            (bb) whether there 
                                        should be a delay of 
                                        submission when 
                                        approval, licensure, or 
                                        clearance will not be 
                                        sought.
                            (v) Additional provisions.--The 
                        regulations under this subparagraph 
                        shall also establish--
                                    (I) a standard format for 
                                the submission of clinical 
                                trial information under this 
                                paragraph to the registry and 
                                results data bank;
                                    (II) additional information 
                                on clinical trials and results 
                                that is written in 
                                nontechnical, understandable 
                                language for patients;
                                    (III) considering the 
                                experience under the pilot 
                                quality control project 
                                described in paragraph (5)(C), 
                                procedures for quality control, 
                                including using representative 
                                samples, with respect to 
                                completeness and content of 
                                clinical trial information 
                                under this subsection, to help 
                                ensure that data elements are 
                                not false or misleading and are 
                                non-promotional;
                                    (IV) the appropriate timing 
                                and requirements for updates of 
                                clinical trial information, and 
                                whether and, if so, how such 
                                updates should be tracked;
                                    (V) a statement to 
                                accompany the entry for an 
                                applicable clinical trial when 
                                the primary and secondary 
                                outcome measures for such 
                                clinical trial are submitted 
                                under paragraph (4)(A) after 
                                the date specified for the 
                                submission of such information 
                                in paragraph (2)(C); and
                                    (VI) additions or 
                                modifications to the manner of 
                                reporting of the data elements 
                                established under subparagraph 
                                (C).
                            (vi) Consideration of world health 
                        organization data set.--The Secretary 
                        shall consider the status of the 
                        consensus data elements set for 
                        reporting clinical trial results of the 
                        World Health Organization when issuing 
                        the regulations under this 
                        subparagraph.
                            (vii) Public meeting.--The 
                        Secretary shall hold a public meeting 
                        no later than 18 months after the date 
                        of the enactment of the Food and Drug 
                        Administration Amendments Act of 2007 
                        to provide an opportunity for input 
                        from interested parties with regard to 
                        the regulations to be issued under this 
                        subparagraph.
                    (E) Submission of results information.--
                            (i) In general.--Except as provided 
                        in clauses (iii), (iv), (v), and (vi) 
                        the responsible party for an applicable 
                        clinical trial that is described in 
                        clause (ii) shall submit to the 
                        Director of NIH for inclusion in the 
                        registry and results data bank the 
                        clinical trial information described in 
                        subparagraph (C) not later than 1 year, 
                        or such other period as may be provided 
                        by regulation under subparagraph (D), 
                        after the earlier of--
                                    (I) the estimated 
                                completion date of the trial as 
                                described in paragraph 
                                (2)(A)(ii)(I)(jj)); or
                                    (II) the actual date of 
                                completion.
                            (ii) Clinical trials described.--An 
                        applicable clinical trial described in 
                        this clause is an applicable clinical 
                        trial subject to--
                                    (I) paragraph (2)(C); and
                                    (II)(aa) subparagraph (C); 
                                or
                                    (bb) the regulations issued 
                                under subparagraph (D).
                            (iii) Delayed submission of results 
                        with certification.--If the responsible 
                        party for an applicable clinical trial 
                        submits a certification that clause 
                        (iv) or (v) applies to such clinical 
                        trial, the responsible party shall 
                        submit to the Director of NIH for 
                        inclusion in the registry and results 
                        data bank the clinical trial 
                        information described in subparagraphs 
                        (C) and (D) as required under the 
                        applicable clause.
                            (iv) Seeking initial approval of a 
                        drug or device.--With respect to an 
                        applicable clinical trial that is 
                        completed before the drug is initially 
                        approved under section 505 of the 
                        Federal Food, Drug, and Cosmetic Act or 
                        initially licensed under section 351 of 
                        this Act, or the device is initially 
                        cleared under section 510(k) or 
                        initially approved under section 515 or 
                        520(m) of the Federal Food, Drug, and 
                        Cosmetic Act, the responsible party 
                        shall submit to the Director of NIH for 
                        inclusion in the registry and results 
                        data bank the clinical trial 
                        information described in subparagraphs 
                        (C) and (D) not later than 30 days 
                        after the drug or device is approved 
                        under such section 505, licensed under 
                        such section 351, cleared under such 
                        section 510(k), or approved under such 
                        section 515 or 520(m), as applicable.
                            (v) Seeking approval of a new use 
                        for the drug or device.--
                                    (I) In general.--With 
                                respect to an applicable 
                                clinical trial where the 
                                manufacturer of the drug or 
                                device is the sponsor of an 
                                applicable clinical trial, and 
                                such manufacturer has filed, or 
                                will file within 1 year, an 
                                application seeking approval 
                                under section 505 of the 
                                Federal Food, Drug, and 
                                Cosmetic Act, licensing under 
                                section 351 of this Act, or 
                                clearance under section 510(k), 
                                or approval under section 515 
                                or 520(m), of the Federal Food, 
                                Drug, and Cosmetic Act for the 
                                use studied in such clinical 
                                trial (which use is not 
                                included in the labeling of the 
                                approved drug or device), then 
                                the responsible party shall 
                                submit to the Director of NIH 
                                for inclusion in the registry 
                                and results data bank the 
                                clinical trial information 
                                described in subparagraphs (C) 
                                and (D) on the earlier of the 
                                date that is 30 days after the 
                                date--
                                            (aa) the new use of 
                                        the drug or device is 
                                        approved under such 
                                        section 505, licensed 
                                        under such section 351, 
                                        cleared under such 
                                        section 510(k), or 
                                        approved under such 
                                        section 515 or 520(m);
                                            (bb) the Secretary 
                                        issues a letter, such 
                                        as a complete response 
                                        letter, not approving 
                                        the submission or not 
                                        clearing the 
                                        submission, a not 
                                        approvable letter, or a 
                                        not substantially 
                                        equivalent letter for 
                                        the new use of the drug 
                                        or device under such 
                                        section 505, 351, 
                                        510(k), 515, or 520(m); 
                                        or
                                            (cc) except as 
                                        provided in subclause 
                                        (III), the application 
                                        or premarket 
                                        notification under such 
                                        section 505, 351, 
                                        510(k), 515, or 520(m) 
                                        is withdrawn without 
                                        resubmission for no 
                                        less than 210 days.
                                    (II) Requirement that each 
                                clinical trial in application 
                                be treated the same.--If a 
                                manufacturer makes a 
                                certification under clause 
                                (iii) that this clause applies 
                                with respect to a clinical 
                                trial, the manufacturer shall 
                                make such a certification with 
                                respect to each applicable 
                                clinical trial that is required 
                                to be submitted in an 
                                application or report for 
                                licensure, approval, or 
                                clearance (under section 351 of 
                                this Act or section 505, 
                                510(k), 515, or 520(m) of the 
                                Federal Food, Drug, and 
                                Cosmetic Act, as applicable) of 
                                the use studied in the clinical 
                                trial.
                                    (III) Two-year 
                                limitation.--The responsible 
                                party shall submit to the 
                                Director of NIH for inclusion 
                                in the registry and results 
                                data bank the clinical trial 
                                information subject to 
                                subclause (I) on the date that 
                                is 2 years after the date a 
                                certification under clause 
                                (iii) was made to the Director 
                                of NIH, if an action referred 
                                to in item (aa), (bb), or (cc) 
                                of subclause (I) has not 
                                occurred by such date.
                            (vi) Extensions.--The Director of 
                        NIH may provide an extension of the 
                        deadline for submission of clinical 
                        trial information under clause (i) if 
                        the responsible party for the trial 
                        submits to the Director a written 
                        request that demonstrates good cause 
                        for the extension and provides an 
                        estimate of the date on which the 
                        information will be submitted. The 
                        Director of NIH may grant more than one 
                        such extension for a clinical trial.
                    (F) Notice to director of nih.--The 
                Commissioner of Food and Drugs shall notify the 
                Director of NIH when there is an action 
                described in subparagraph (E)(iv) or item (aa), 
                (bb), or (cc) of subparagraph (E)(v)(I) with 
                respect to an application or a report that 
                includes a certification required under 
                paragraph (5)(B) of such action not later than 
                30 days after such action.
                    (G) Posting of data.--The Director of NIH 
                shall ensure that the clinical trial 
                information described in subparagraphs (C) and 
                (D) for an applicable clinical trial submitted 
                in accordance with this paragraph is posted 
                publicly in the registry and results database 
                not later than 30 days after such submission.
                    (H) Waivers regarding certain clinical 
                trial results.--The Secretary may waive any 
                applicable requirements of this paragraph for 
                an applicable clinical trial, upon a written 
                request from the responsible party, if the 
                Secretary determines that extraordinary 
                circumstances justify the waiver and that 
                providing the waiver is consistent with the 
                protection of public health, or in the interest 
                of national security. Not later than 30 days 
                after any part of a waiver is granted, the 
                Secretary shall notify, in writing, the 
                appropriate committees of Congress of the 
                waiver and provide an explanation for why the 
                waiver was granted.
                    (I) Adverse events.--
                            (i) Regulations.--Not later than 18 
                        months after the date of the enactment 
                        of the Food and Drug Administration 
                        Amendments Act of 2007, the Secretary 
                        shall by regulation determine the best 
                        method for including in the registry 
                        and results data bank appropriate 
                        results information on serious adverse 
                        and frequent adverse events for 
                        applicable clinical trials described in 
                        subparagraph (C) in a manner and form 
                        that is useful and not misleading to 
                        patients, physicians, and scientists.
                            (ii) Default.--If the Secretary 
                        fails to issue the regulation required 
                        by clause (i) by the date that is 24 
                        months after the date of the enactment 
                        of the Food and Drug Administration 
                        Amendments Act of 2007, clause (iii) 
                        shall take effect.
                            (iii) Additional elements.--Upon 
                        the application of clause (ii), the 
                        Secretary shall include in the registry 
                        and results data bank for applicable 
                        clinical trials described in 
                        subparagraph (C), in addition to the 
                        clinical trial information described in 
                        subparagraph (C), the following 
                        elements:
                                    (I) Serious adverse 
                                events.--A table of anticipated 
                                and unanticipated serious 
                                adverse events grouped by organ 
                                system, with number and 
                                frequency of such event in each 
                                arm of the clinical trial.
                                    (II) Frequent adverse 
                                events.--A table of anticipated 
                                and unanticipated adverse 
                                events that are not included in 
                                the table described in 
                                subclause (I) that exceed a 
                                frequency of 5 percent within 
                                any arm of the clinical trial, 
                                grouped by organ system, with 
                                number and frequency of such 
                                event in each arm of the 
                                clinical trial.
                            (iv) Posting of other 
                        information.--In carrying out clause 
                        (iii), the Secretary shall, in 
                        consultation with experts in risk 
                        communication, post with the tables 
                        information to enhance patient 
                        understanding and to ensure such tables 
                        do not mislead patients or the lay 
                        public.
                            (v) Relation to subparagraph (c).--
                        Clinical trial information included in 
                        the registry and results data bank 
                        pursuant to this subparagraph is deemed 
                        to be clinical trial information 
                        included in such data bank pursuant to 
                        subparagraph (C).
            (4) Additional submissions of clinical trial 
        information.--
                    (A) Voluntary submissions.--A responsible 
                party for a clinical trial that is not an 
                applicable clinical trial, or that is an 
                applicable clinical trial that is not subject 
                to paragraph (2)(C), may submit complete 
                clinical trial information described in 
                paragraph (2) or paragraph (3) provided the 
                responsible party submits clinical trial 
                information for each applicable clinical trial 
                that is required to be submitted under section 
                351 or under section 505, 510(k), 515, or 
                520(m) of the Federal Food, Drug, and Cosmetic 
                Act in an application or report for licensure, 
                approval, or clearance of the drug or device 
                for the use studied in the clinical trial.
                    (B) Required submissions.--
                            (i) In general.--Notwithstanding 
                        paragraphs (2) and (3) and subparagraph 
                        (A), in any case in which the Secretary 
                        determines for a specific clinical 
                        trial described in clause (ii) that 
                        posting in the registry and results 
                        data bank of clinical trial information 
                        for such clinical trial is necessary to 
                        protect the public health--
                                    (I) the Secretary may 
                                require by notification that 
                                such information be submitted 
                                to the Secretary in accordance 
                                with paragraphs (2) and (3) 
                                except with regard to timing of 
                                submission;
                                    (II) unless the responsible 
                                party submits a certification 
                                under paragraph (3)(E)(iii), 
                                such information shall be 
                                submitted not later than 30 
                                days after the date specified 
                                by the Secretary in the 
                                notification; and
                                    (III) failure to comply 
                                with the requirements under 
                                subclauses (I) and (II) shall 
                                be treated as a violation of 
                                the corresponding requirement 
                                of such paragraphs.
                            (ii) Clinical trials described.--A 
                        clinical trial described in this clause 
                        is--
                                    (I) an applicable clinical 
                                trial for a drug that is 
                                approved under section 505 of 
                                the Federal Food, Drug, and 
                                Cosmetic Act or licensed under 
                                section 351 of this Act or for 
                                a device that is cleared under 
                                section 510(k) of the Federal 
                                Food, Drug, and Cosmetic Act or 
                                approved under section 515 or 
                                section 520(m) of such Act, 
                                whose completion date is on or 
                                after the date 10 years before 
                                the date of the enactment of 
                                the Food and Drug 
                                Administration Amendments Act 
                                of 2007; or
                                    (II) an applicable clinical 
                                trial that is described by both 
                                by paragraph (2)(C) and 
                                paragraph (3)(D)(ii)(II)).
                    (C) Updates to clinical trial data bank.--
                            (i) Submission of updates.--The 
                        responsible party for an applicable 
                        clinical trial shall submit to the 
                        Director of NIH for inclusion in the 
                        registry and results data bank updates 
                        to reflect changes to the clinical 
                        trial information submitted under 
                        paragraph (2). Such updates--
                                    (I) shall be provided not 
                                less than once every 12 months, 
                                unless there were no changes to 
                                the clinical trial information 
                                during the preceding 12-month 
                                period;
                                    (II) shall include 
                                identification of the dates of 
                                any such changes;
                                    (III) not later than 30 
                                days after the recruitment 
                                status of such clinical trial 
                                changes, shall include an 
                                update of the recruitment 
                                status; and
                                    (IV) not later than 30 days 
                                after the completion date of 
                                the clinical trial, shall 
                                include notification to the 
                                Director that such clinical 
                                trial is complete.
                            (ii) Public availability of 
                        updates.--The Director of NIH shall 
                        make updates submitted under clause (i) 
                        publicly available in the registry data 
                        bank. Except with regard to overall 
                        recruitment status, individual site 
                        status, location, and contact 
                        information, the Director of NIH shall 
                        ensure that updates to elements 
                        required under subclauses (I) to (V) of 
                        paragraph (2)(A)(ii) do not result in 
                        the removal of any information from the 
                        original submissions or any preceding 
                        updates, and information in such 
                        databases is presented in a manner that 
                        enables users to readily access each 
                        original element submission and to 
                        track the changes made by the updates. 
                        The Director of NIH shall provide a 
                        link from the table of primary and 
                        secondary outcomes required under 
                        paragraph (3)(C)(ii) to the tracked 
                        history required under this clause of 
                        the primary and secondary outcome 
                        measures submitted under paragraph 
                        (2)(A)(ii)(I)(ll).
            (5) Coordination and compliance.--
                    (A) Clinical trials supported by grants 
                from federal agencies.--
                            (i) Grants from certain federal 
                        agencies.--If an applicable clinical 
                        trial is funded in whole or in part by 
                        a grant from any agency of the 
                        Department of Health and Human 
                        Services, including the Food and Drug 
                        Administration, the National Institutes 
                        of Health, or the Agency for Healthcare 
                        Research and Quality, any grant or 
                        progress report forms required under 
                        such grant shall include a 
                        certification that the responsible 
                        party has made all required submissions 
                        to the Director of NIH under paragraphs 
                        (2) and (3).
                            (ii) Verification by federal 
                        agencies.--The heads of the agencies 
                        referred to in clause (i), as 
                        applicable, shall verify that the 
                        clinical trial information for each 
                        applicable clinical trial for which a 
                        grantee is the responsible party has 
                        been submitted under paragraphs (2) and 
                        (3) before releasing any remaining 
                        funding for a grant or funding for a 
                        future grant to such grantee.
                            (iii) Notice and opportunity to 
                        remedy.--If the head of an agency 
                        referred to in clause (i), as 
                        applicable, verifies that a grantee has 
                        not submitted clinical trial 
                        information as described in clause 
                        (ii), such agency head shall provide 
                        notice to such grantee of such non-
                        compliance and allow such grantee 30 
                        days to correct such non-compliance and 
                        submit the required clinical trial 
                        information.
                            (iv) Consultation with other 
                        federal agencies.--The Secretary 
                        shall--
                                    (I) consult with other 
                                agencies that conduct research 
                                involving human subjects in 
                                accordance with any section of 
                                part 46 of title 45, Code of 
                                Federal Regulations (or any 
                                successor regulations), to 
                                determine if any such research 
                                is an applicable clinical 
                                trial; and
                                    (II) develop with such 
                                agencies procedures comparable 
                                to those described in clauses 
                                (i), (ii), and (iii) to ensure 
                                that clinical trial information 
                                for such applicable clinical 
                                trial is submitted under 
                                paragraphs (2) and (3).
                    (B) Certification to accompany drug, 
                biological product, and device submissions.--At 
                the time of submission of an application under 
                section 505 of the Federal Food, Drug, and 
                Cosmetic Act, section 515 of such Act, section 
                520(m) of such Act, or section 351 of this Act, 
                or submission of a report under section 510(k) 
                of such Act, such application or submission 
                shall be accompanied by a certification that 
                all applicable requirements of this subsection 
                have been met. Where available, such 
                certification shall include the appropriate 
                National Clinical Trial control numbers.
                    (C) Quality control.--
                            (i) Pilot quality control 
                        project.--Until the effective date of 
                        the regulations issued under paragraph 
                        (3)(D), the Secretary, acting through 
                        the Director of NIH and the 
                        Commissioner of Food and Drugs, shall 
                        conduct a pilot project to determine 
                        the optimal method of verification to 
                        help to ensure that the clinical trial 
                        information submitted under paragraph 
                        (3)(C) is non-promotional and is not 
                        false or misleading in any particular 
                        under subparagraph (D). The Secretary 
                        shall use the publicly available 
                        information described in paragraph 
                        (3)(A) and any other information 
                        available to the Secretary about 
                        applicable clinical trials to verify 
                        the accuracy of the clinical trial 
                        information submitted under paragraph 
                        (3)(C).
                            (ii) Notice of compliance.--If the 
                        Secretary determines that any clinical 
                        trial information was not submitted as 
                        required under this subsection, or was 
                        submitted but is false or misleading in 
                        any particular, the Secretary shall 
                        notify the responsible party and give 
                        such party an opportunity to remedy 
                        such noncompliance by submitting the 
                        required revised clinical trial 
                        information not later than 30 days 
                        after such notification.
                    (D) Truthful clinical trial information.--
                            (i) In general.--The clinical trial 
                        information submitted by a responsible 
                        party under this subsection shall not 
                        be false or misleading in any 
                        particular.
                            (ii) Effect.--Clause (i) shall not 
                        have the effect of--
                                    (I) requiring clinical 
                                trial information with respect 
                                to an applicable clinical trial 
                                to include information from any 
                                source other than such clinical 
                                trial involved; or
                                    (II) requiring clinical 
                                trial information described in 
                                paragraph (3)(D) to be 
                                submitted for purposes of 
                                paragraph (3)(C).
                    (E) Public notices.--
                            (i) Notice of violations.--If the 
                        responsible party for an applicable 
                        clinical trial fails to submit clinical 
                        trial information for such clinical 
                        trial as required under paragraphs (2) 
                        or (3), the Director of NIH shall 
                        include in the registry and results 
                        data bank entry for such clinical trial 
                        a notice--
                                    (I) that the responsible 
                                party is not in compliance with 
                                this Act by--
                                            (aa) failing to 
                                        submit required 
                                        clinical trial 
                                        information; or
                                            (bb) submitting 
                                        false or misleading 
                                        clinical trial 
                                        information;
                                    (II) of the penalties 
                                imposed for the violation, if 
                                any; and
                                    (III) whether the 
                                responsible party has corrected 
                                the clinical trial information 
                                in the registry and results 
                                data bank.
                            (ii) Notice of failure to submit 
                        primary and secondary outcomes.--If the 
                        responsible party for an applicable 
                        clinical trial fails to submit the 
                        primary and secondary outcomes as 
                        required under section 2(A)(ii)(I)(ll), 
                        the Director of NIH shall include in 
                        the registry and results data bank 
                        entry for such clinical trial a notice 
                        that the responsible party is not in 
                        compliance by failing to register the 
                        primary and secondary outcomes in 
                        accordance with this act, and that the 
                        primary and secondary outcomes were not 
                        publicly disclosed in the database 
                        before conducting the clinical trial.
                            (iii) Failure to submit 
                        statement.--The notice under clause (i) 
                        for a violation described in clause 
                        (i)(I)(aa) shall include the following 
                        statement: ``The entry for this 
                        clinical trial was not complete at the 
                        time of submission, as required by law. 
                        This may or may not have any bearing on 
                        the accuracy of the information in the 
                        entry.''.
                            (iv) Submission of false 
                        information statement.--The notice 
                        under clause (i) for a violation 
                        described in clause (i)(I)(bb) shall 
                        include the following statement: ``The 
                        entry for this clinical trial was found 
                        to be false or misleading and therefore 
                        not in compliance with the law.''.
                            (v) Non-submission of statement.--
                        The notice under clause (ii) for a 
                        violation described in clause (ii) 
                        shall include the following statement: 
                        ``The entry for this clinical trial did 
                        not contain information on the primary 
                        and secondary outcomes at the time of 
                        submission, as required by law. This 
                        may or may not have any bearing on the 
                        accuracy of the information in the 
                        entry.''.
                            (vi) Compliance searches.--The 
                        Director of NIH shall provide that the 
                        public may easily search the registry 
                        and results data bank for entries that 
                        include notices required under this 
                        subparagraph.
            (6) Limitation on disclosure of clinical trial 
        information.--
                    (A) In general.--Nothing in this subsection 
                (or under section 552 of title 5, United States 
                Code) shall require the Secretary to publicly 
                disclose, by any means other than the registry 
                and results data bank, information described in 
                subparagraph (B).
                    (B) Information described.--Information 
                described in this subparagraph is--
                            (i) information submitted to the 
                        Director of NIH under this subsection, 
                        or information of the same general 
                        nature as (or integrally associated 
                        with) the information so submitted; and
                            (ii) information not otherwise 
                        publicly available, including because 
                        it is protected from disclosure under 
                        section 552 of title 5, United States 
                        Code.
            (7) Authorization of appropriations.--There are 
        authorized to be appropriated to carry out this 
        subsection $10,000,000 for each fiscal year.
    (k)(1) The Director of NIH may establish a program to 
provide day care services for the employees of the National 
Institutes of Health similar to those services provided by 
other Federal agencies (including the availability of day care 
service on a 24-hour-a-day basis).
    (2) Any day care provider at the National Institutes of 
Health shall establish a sliding scale of fees that takes into 
consideration the income and needs of the employee.
    (3) For purposes regarding the provision of day care 
services, the Director of NIH may enter into rental or lease 
purchase agreements.
    (l) Council of Councils.--
            (1) Establishment.--Not later than 90 days after 
        the date of the enactment of the National Institutes of 
        Health Reform Act of 2006, the Director of NIH shall 
        establish within the Office of the Director an advisory 
        council to be known as the ``Council of Councils'' 
        (referred to in this subsection as the ``Council'') for 
        the purpose of advising the Director on matters related 
        to the policies and activities of the Division of 
        Program Coordination, Planning, and Strategic 
        Initiatives, including making recommendations with 
        respect to the conduct and support of research 
        described in subsection (b)(7).
            (2) Membership.--
                    (A) In general.--The Council shall be 
                composed of 27 members selected by the Director 
                of NIH with approval from the Secretary from 
                among the list of nominees under subparagraph 
                (C).
                    (B) Certain requirements.--In selecting the 
                members of the Council, the Director of NIH 
                shall ensure--
                            (i) the representation of a broad 
                        range of disciplines and perspectives; 
                        and
                            (ii) the ongoing inclusion of at 
                        least 1 representative from each 
                        national research institute whose 
                        budget is substantial relative to a 
                        majority of the other institutes.
                    (C) Nomination.--The Director of NIH shall 
                maintain an updated list of individuals who 
                have been nominated to serve on the Council, 
                which list shall consist of the following:
                            (i) For each national research 
                        institute and national center, 3 
                        individuals nominated by the head of 
                        such institute or center from among the 
                        members of the advisory council of the 
                        institute or center, of which--
                                    (I) two shall be 
                                scientists; and
                                    (II) one shall be from the 
                                general public or shall be a 
                                leader in the field of public 
                                policy, law, health policy, 
                                economics, or management.
                            (ii) For each office within the 
                        Division of Program Coordination, 
                        Planning, and Strategic Initiatives, 1 
                        individual nominated by the head of 
                        such office.
                            (iii) Members of the Council of 
                        Public Representatives.
            (3) Terms.--
                    (A) In general.--The term of service for a 
                member of the Council shall be 6 years, except 
                as provided in subparagraphs (B) and (C).
                    (B) Terms of initial appointees.--Of the 
                initial members selected for the Council, the 
                Director of NIH shall designate--
                            (i) nine for a term of 6 years;
                            (ii) nine for a term of 4 years; 
                        and
                            (iii) nine for a term of 2 years.
                    (C) Vacancies.--Any member appointed to 
                fill a vacancy occurring before the expiration 
                of the term for which the member's predecessor 
                was appointed shall be appointed only for the 
                remainder of that term. A member may serve 
                after the expiration of that member's term 
                until a successor has taken office.

SEC. 402A. [282A] AUTHORIZATION OF APPROPRIATIONS.

    (a) In General.--For the purpose of carrying out this 
title, there are authorized to be appropriated--
            (1) $30,331,309,000 for fiscal year 2007;
            (2) $32,831,309,000 for fiscal year 2008; and
            (3) such sums as may be necessary for fiscal year 
        2009.
    (b) Office of the Director.--Of the amount authorized to be 
appropriated under subsection (a) for a fiscal year, there are 
authorized to be appropriated for programs and activities under 
this title carried out through the Office of the Director of 
NIH such sums as may be necessary for each of the fiscal years 
2007 through 2009.
    (c) Trans-NIH Research.--
            (1) Common fund.--
                    (A) Account.--For the purpose of 
                allocations under section 402(b)(7)(B) 
                (relating to research identified by the 
                Division of Program Coordination, Planning, and 
                Strategic Initiatives), there is established an 
                account to be known as the Common Fund.
                    (B) Reservation.--
                            (i) In general.--Of the total 
                        amount appropriated under subsection 
                        (a) for fiscal year 2007 or any 
                        subsequent fiscal year, the Director of 
                        NIH shall reserve an amount for the 
                        Common Fund, subject to any applicable 
                        provisions in appropriations Acts.
                            (ii) Minimum amount.--For each 
                        fiscal year, the percentage constituted 
                        by the amount reserved under clause (i) 
                        relative to the total amount 
                        appropriated under subsection (a) for 
                        such year may not be less than the 
                        percentage constituted by the amount so 
                        reserved for the preceding fiscal year 
                        relative to the total amount 
                        appropriated under subsection (a) for 
                        such preceding fiscal year, subject to 
                        any applicable provisions in 
                        appropriations Acts.
                    (C) Common fund strategic planning 
                report.--Not later than June 1, 2007, and every 
                2 years thereafter, the Secretary, acting 
                through the Director of NIH, shall submit a 
                report to the Congress containing a strategic 
                plan for funding research described in section 
                402(b)(7)(A)(i) (including personnel needs) 
                through the Common Fund. Each such plan shall 
                include the following:
                            (i) An estimate of the amounts 
                        determined by the Director of NIH to be 
                        appropriate for maximizing the 
                        potential of such research.
                            (ii) An estimate of the amounts 
                        determined by the Director of NIH to be 
                        sufficient only for continuing to fund 
                        research activities previously 
                        identified by the Division of Program 
                        Coordination, Planning, and Strategic 
                        Initiatives.
                            (iii) An estimate of the amounts 
                        determined by the Director of NIH to be 
                        necessary to fund research described in 
                        section 402(b)(7)(A)(i)--
                                    (I) that is in addition to 
                                the research activities 
                                described in clause (ii); and
                                    (II) for which there is the 
                                most substantial need.
                    (D) Evaluation.--During the 6-month period 
                following the end of the first fiscal year for 
                which the total amount reserved under 
                subparagraph (B) is equal to 5 percent of the 
                total amount appropriated under subsection (a) 
                for such fiscal year, the Secretary, acting 
                through the Director of NIH, in consultation 
                with the advisory council established under 
                section 402(k), shall submit recommendations to 
                the Congress for changes regarding amounts for 
                the Common Fund.
            (2) Trans-nih research reporting.--
                    (A) Limitation.--With respect to the total 
                amount appropriated under subsection (a) for 
                fiscal year 2008 or any subsequent fiscal year, 
                if the head of a national research institute or 
                national center fails to submit the report 
                required by subparagraph (B) for the preceding 
                fiscal year, the amount made available for the 
                institute or center for the fiscal year 
                involved may not exceed the amount made 
                available for the institute or center for 
                fiscal year 2006.
                    (B) Reporting.--Not later than January 1, 
                2008, and each January 1st thereafter--
                            (i) the head of each national 
                        research institute or national center 
                        shall submit to the Director of NIH a 
                        report on the amount made available by 
                        the institute or center for conducting 
                        or supporting research that involves 
                        collaboration between the institute or 
                        center and 1 or more other national 
                        research institutes or national 
                        centers; and
                            (ii) the Secretary shall submit a 
                        report to the Congress identifying the 
                        percentage of funds made available by 
                        each national research institute and 
                        national center with respect to such 
                        fiscal year for conducting or 
                        supporting research described in clause 
                        (i).
                    (C) Determination.--For purposes of 
                determining the amount or percentage of funds 
                to be reported under subparagraph (B), any 
                amounts made available to an institute or 
                center under section 402(b)(7)(B) shall be 
                included.
                    (D) Verification of amounts.--Upon receipt 
                of each report submitted under subparagraph 
                (B)(i), the Director of NIH shall review and, 
                in cases of discrepancy, verify the accuracy of 
                the amounts specified in the report.
                    (E) Waiver.--At the request of any national 
                research institute or national center, the 
                Director of NIH may waive the application of 
                this paragraph to such institute or center if 
                the Director finds that the conduct or support 
                of research described in subparagraph (B)(i) is 
                inconsistent with the mission of such institute 
                or center.
    (d) Transfer Authority.--Of the total amount appropriated 
under subsection (a) for a fiscal year, the Director of NIH may 
(in addition to the reservation under subsection (c)(1) for 
such year) transfer not more than 1 percent for programs or 
activities that are authorized in this title and identified by 
the Director to receive funds pursuant to this subsection. In 
making such transfers, the Director may not decrease any 
appropriation account under subsection (a) by more than 1 
percent.
    (e) Rule of Construction.--This section may not be 
construed as affecting the authorities of the Director of NIH 
under section 401.

SEC. 402B. [282B] ELECTRONIC CODING OF GRANTS AND ACTIVITIES.

    The Secretary, acting through the Director of NIH, shall 
establish an electronic system to uniformly code research 
grants and activities of the Office of the Director and of all 
the national research institutes and national centers. The 
electronic system shall be searchable by a variety of codes, 
such as the type of research grant, the research entity 
managing the grant, and the public health area of interest. 
When permissible, the Secretary, acting through the Director of 
NIH, shall provide information on relevant literature and 
patents that are associated with research activities of the 
National Institutes of Health.

SEC. 402C. [282D] CURES ACCELERATION NETWORK.

    (a) Definitions.--In this section:
            (1) Biological product.--The term ``biological 
        product'' has the meaning given such term in section 
        351 of the Public Health Service Act.
            (2) Drug; device.--The terms ``drug'' and 
        ``device'' have the meanings given such terms in 
        section 201 of the Federal Food, Drug, and Cosmetic 
        Act.
            (3) High need cure.--The term ``high need cure'' 
        means a drug (as that term is defined by section 
        201(g)(1) of the Federal Food, Drug, and Cosmetic Act, 
        biological product (as that term is defined by section 
        262(i)), or device (as that term is defined by section 
        201(h) of the Federal Food, Drug, and Cosmetic Act) 
        that, in the determination of the Director of NIH--
                    (A) is a priority to diagnose, mitigate, 
                prevent, or treat harm from any disease or 
                condition; and
                    (B) for which the incentives of the 
                commercial market are unlikely to result in its 
                adequate or timely development.
            (4) Medical product.--The term ``medical product'' 
        means a drug, device, biological product, or product 
        that is a combination of drugs, devices, and biological 
        products.
    (b) Establishment of the Cures Acceleration Network.--
Subject to the appropriation of funds as described in 
subsection (g), there is established within the Office of the 
Director of NIH a program to be known as the Cures Acceleration 
Network (referred to in this section as ``CAN''), which shall--
            (1) be under the direction of the Director of NIH, 
        taking into account the recommendations of a CAN Review 
        Board (referred to in this section as the ``Board''), 
        described in subsection (d); and
            (2) award grants and contracts to eligible 
        entities, as described in subsection (e), to accelerate 
        the development of high need cures, including through 
        the development of medical products and behavioral 
        therapies.
    (c) Functions.--The functions of the CAN are to--
            (1) conduct and support revolutionary advances in 
        basic research, translating scientific discoveries from 
        bench to bedside;
            (2) award grants and contracts to eligible entities 
        to accelerate the development of high need cures;
            (3) provide the resources necessary for government 
        agencies, independent investigators, research 
        organizations, biotechnology companies, academic 
        research institutions, and other entities to develop 
        high need cures;
            (4) reduce the barriers between laboratory 
        discoveries and clinical trials for new therapies; and
            (5) facilitate review in the Food and Drug 
        Administration for the high need cures funded by the 
        CAN, through activities that may include--
                    (A) the facilitation of regular and ongoing 
                communication with the Food and Drug 
                Administration regarding the status of 
                activities conducted under this section;
                    (B) ensuring that such activities are 
                coordinated with the approval requirements of 
                the Food and Drug Administration, with the goal 
                of expediting the development and approval of 
                countermeasures and products; and
                    (C) connecting interested persons with 
                additional technical assistance made available 
                under section 565 of the Federal Food, Drug, 
                and Cosmetic Act.
    (d) CAN Board.--
            (1) Establishment.--There is established a Cures 
        Acceleration Network Review Board (referred to in this 
        section as the ``Board''), which shall advise the 
        Director of NIH on the conduct of the activities of the 
        Cures Acceleration Network.
            (2) Membership.--
                    (A) In general.--
                            (i) Appointment.--The Board shall 
                        be comprised of 24 members who are 
                        appointed by the Secretary and who 
                        serve at the pleasure of the Secretary.
                            (ii) Chairperson and vice 
                        chairperson.--The Secretary shall 
                        designate, from among the 24 members 
                        appointed under clause (i), one 
                        Chairperson of the Board (referred to 
                        in this section as the ``Chairperson'') 
                        and one Vice Chairperson.
                    (B) Terms.--
                            (i) In general.--Each member shall 
                        be appointed to serve a 4-year term, 
                        except that any member appointed to 
                        fill a vacancy occurring prior to the 
                        expiration of the term for which the 
                        member's predecessor was appointed 
                        shall be appointed for the remainder of 
                        such term.
                            (ii) Consecutive appointments; 
                        maximum terms.--A member may be 
                        appointed to serve not more than 3 
                        terms on the Board, and may not serve 
                        more than 2 such terms consecutively.
                    (C) Qualifications.--
                            (i) In general.--The Secretary 
                        shall appoint individuals to the Board 
                        based solely upon the individual's 
                        established record of distinguished 
                        service in one of the areas of 
                        expertise described in clause (ii). 
                        Each individual appointed to the Board 
                        shall be of distinguished achievement 
                        and have a broad range of disciplinary 
                        interests.
                            (ii) Expertise.--The Secretary 
                        shall select individuals based upon the 
                        following requirements:
                                    (I) For each of the fields 
                                of--
                                            (aa) basic 
                                        research;
                                            (bb) medicine;
                                            (cc) 
                                        biopharmaceuticals;
                                            (dd) discovery and 
                                        delivery of medical 
                                        products;
                                            (ee) bioinformatics 
                                        and gene therapy;
                                            (ff) medical 
                                        instrumentation; and
                                            (gg) regulatory 
                                        review and approval of 
                                        medical products,
                                the Secretary shall select at 
                                least 1 individual who is 
                                eminent in such fields.
                                    (II) At least 4 individuals 
                                shall be recognized leaders in 
                                professional venture capital or 
                                private equity organizations 
                                and have demonstrated 
                                experience in private equity 
                                investing.
                                    (III) At least 8 
                                individuals shall represent 
                                disease advocacy organizations.
            (3) Ex-officio members.--
                    (A) Appointment.--In addition to the 24 
                Board members described in paragraph (2), the 
                Secretary shall appoint as ex-officio members 
                of the Board--
                            (i) a representative of the 
                        National Institutes of Health, 
                        recommended by the Secretary of the 
                        Department of Health and Human 
                        Services;
                            (ii) a representative of the Office 
                        of the Assistant Secretary of Defense 
                        for Health Affairs, recommended by the 
                        Secretary of Defense;
                            (iii) a representative of the 
                        Office of the Under Secretary for 
                        Health for the Veterans Health 
                        Administration, recommended by the 
                        Secretary of Veterans Affairs;
                            (iv) a representative of the 
                        National Science Foundation, 
                        recommended by the Chair of the 
                        National Science Board; and
                            (v) a representative of the Food 
                        and Drug Administration, recommended by 
                        the Commissioner of Food and Drugs.
                    (B) Terms.--Each ex-officio member shall 
                serve a 3-year term on the Board, except that 
                the Chairperson may adjust the terms of the 
                initial ex-officio members in order to provide 
                for a staggered term of appointment for all 
                such members.
            (4) Responsibilities of the board and the director 
        of nih.--
                    (A) Responsibilities of the board.--
                            (i) In general.--The Board shall 
                        advise, and provide recommendations to, 
                        the Director of NIH with respect to--
                                    (I) policies, programs, and 
                                procedures for carrying out the 
                                duties of the Director of NIH 
                                under this section; and
                                    (II) significant barriers 
                                to successful translation of 
                                basic science into clinical 
                                application (including issues 
                                under the purview of other 
                                agencies and departments).
                            (ii) Report.--In the case that the 
                        Board identifies a significant barrier, 
                        as described in clause (i)(II), the 
                        Board shall submit to the Secretary a 
                        report regarding such barrier.
                    (B) Responsibilities of the director of 
                nih.--With respect to each recommendation 
                provided by the Board under subparagraph 
                (A)(i), the Director of NIH shall respond in 
                writing to the Board, indicating whether such 
                Director will implement such recommendation. In 
                the case that the Director of NIH indicates a 
                recommendation of the Board will not be 
                implemented, such Director shall provide an 
                explanation of the reasons for not implementing 
                such recommendation.
            (5) Meetings.--
                    (A) In general.--The Board shall meet 4 
                times per calendar year, at the call of the 
                Chairperson.
                    (B) Quorum; requirements; limitations.--
                            (i) Quorum.--A quorum shall consist 
                        of a total of 13 members of the Board, 
                        excluding ex-officio members, with 
                        diverse representation as described in 
                        clause (iii).
                            (ii) Chairperson or vice 
                        chairperson.--Each meeting of the Board 
                        shall be attended by either the 
                        Chairperson or the Vice Chairperson.
                            (iii) Diverse representation.--At 
                        each meeting of the Board, there shall 
                        be not less than one scientist, one 
                        representative of a disease advocacy 
                        organization, and one representative of 
                        a professional venture capital or 
                        private equity organization.
            (6) Compensation and travel expenses.--
                    (A) Compensation.--Members shall receive 
                compensation at a rate to be fixed by the 
                Chairperson but not to exceed a rate equal to 
                the daily equivalent of the annual rate of 
                basic pay prescribed for level IV of the 
                Executive Schedule under section 5315 of title 
                5, United States Code, for each day (including 
                travel time) during which the member is engaged 
                in the performance of the duties of the Board. 
                All members of the Board who are officers or 
                employees of the United States shall serve 
                without compensation in addition to that 
                received for their services as officers or 
                employees of the United States.
                    (B) Travel expenses.--Members of the Board 
                shall be allowed travel expenses, including per 
                diem in lieu of subsistence, at rates 
                authorized for persons employed intermittently 
                by the Federal Government under section 5703(b) 
                of title 5, United States Code, while away from 
                their homes or regular places of business in 
                the performance of services for the Board.
    (e) Grant Program.--
            (1) Supporting innovation.--To carry out the 
        purposes described in this section, the Director of NIH 
        shall award contracts, grants, or cooperative 
        agreements to the entities described in paragraph (2), 
        to--
                    (A) promote innovation in technologies 
                supporting the advanced research and 
                development and production of high need cures, 
                including through the development of medical 
                products and behavioral therapies.
                    (B) accelerate the development of high need 
                cures, including through the development of 
                medical products, behavioral therapies, and 
                biomarkers that demonstrate the safety or 
                effectiveness of medical products; or
                    (C) help the award recipient establish 
                protocols that comply with Food and Drug 
                Administration standards and otherwise permit 
                the recipient to meet regulatory requirements 
                at all stages of development, manufacturing, 
                review, approval, and safety surveillance of a 
                medical product.
            (2) Eligible entities.--To receive assistance under 
        paragraph (1), an entity shall--
                    (A) be a public or private entity, which 
                may include a private or public research 
                institution, an institution of higher 
                education, a medical center, a biotechnology 
                company, a pharmaceutical company, a disease 
                advocacy organization, a patient advocacy 
                organization, or an academic research 
                institution;
                    (B) submit an application containing--
                            (i) a detailed description of the 
                        project for which the entity seeks such 
                        grant or contract;
                            (ii) a timetable for such project;
                            (iii) an assurance that the entity 
                        will submit--
                                    (I) interim reports 
                                describing the entity's--
                                            (aa) progress in 
                                        carrying out the 
                                        project; and
                                            (bb) compliance 
                                        with all provisions of 
                                        this section and 
                                        conditions of receipt 
                                        of such grant or 
                                        contract; and
                                    (II) a final report at the 
                                conclusion of the grant period, 
                                describing the outcomes of the 
                                project; and
                            (iv) a description of the protocols 
                        the entity will follow to comply with 
                        Food and Drug Administration standards 
                        and regulatory requirements at all 
                        stages of development, manufacturing, 
                        review, approval, and safety 
                        surveillance of a medical product; and
                    (C) provide such additional information as 
                the Director of NIH may require.
            (3) Awards.--
                    (A) The cures acceleration partnership 
                awards.--
                            (i) Initial award amount.--Each 
                        award under this subparagraph shall be 
                        not more than $15,000,000 per project 
                        for the first fiscal year for which the 
                        project is funded, which shall be 
                        payable in one payment.
                            (ii) Funding in subsequent fiscal 
                        years.--An eligible entity receiving an 
                        award under clause (i) may apply for 
                        additional funding for such project by 
                        submitting to the Director of NIH the 
                        information required under 
                        subparagraphs (B) and (C) of paragraph 
                        (2). The Director may fund a project of 
                        such eligible entity in an amount not 
                        to exceed $15,000,000 for a fiscal year 
                        subsequent to the initial award under 
                        clause (i).
                            (iii) Matching funds.--As a 
                        condition for receiving an award under 
                        this subsection, an eligible entity 
                        shall contribute to the project non-
                        Federal funds in the amount of $1 for 
                        every $3 awarded under clauses (i) and 
                        (ii), except that the Director of NIH 
                        may waive or modify such matching 
                        requirement in any case where the 
                        Director determines that the goals and 
                        objectives of this section cannot 
                        adequately be carried out unless such 
                        requirement is waived.
                    (B) The cures acceleration grant awards.--
                            (i) Initial award amount.--Each 
                        award under this subparagraph shall be 
                        not more than $15,000,000 per project 
                        for the first fiscal year for which the 
                        project is funded, which shall be 
                        payable in one payment.
                            (ii) Funding in subsequent fiscal 
                        years.--An eligible entity receiving an 
                        award under clause (i) may apply for 
                        additional funding for such project by 
                        submitting to the Board the information 
                        required under subparagraphs (B) and 
                        (C) of paragraph (2). The Director of 
                        NIH may fund a project of such eligible 
                        entity in an amount not to exceed 
                        $15,000,000 for a fiscal year 
                        subsequent to the initial award under 
                        clause (i).
                    (C) The cures acceleration flexible 
                research awards.--If the Director of NIH 
                determines that the goals and objectives of 
                this section cannot adequately be carried out 
                through a contract, grant, or cooperative 
                agreement, the Director of NIH shall have 
                flexible research authority to use other 
                transactions to fund projects in accordance 
                with the terms and conditions of this section. 
                Awards made under such flexible research 
                authority for a fiscal year shall not exceed 20 
                percent of the total funds appropriated under 
                subsection (g)(1) for such fiscal year.
            (4) Suspension of awards for defaults, 
        noncompliance with provisions and plans, and diversion 
        of funds; repayment of funds.--The Director of NIH may 
        suspend the award to any entity upon noncompliance by 
        such entity with provisions and plans under this 
        section or diversion of funds.
            (5) Audits.--The Director of NIH may enter into 
        agreements with other entities to conduct periodic 
        audits of the projects funded by grants or contracts 
        awarded under this subsection.
            (6) Closeout procedures.--At the end of a grant or 
        contract period, a recipient shall follow the closeout 
        procedures under section 74.71 of title 45, Code of 
        Federal Regulations (or any successor regulation).
            (7) Review.--A determination by the Director of NIH 
        as to whether a drug, device, or biological product is 
        a high need cure (for purposes of subsection (a)(3)) 
        shall not be subject to judicial review.
    (f) Competitive Basis of Awards.--Any grant, cooperative 
agreement, or contract awarded under this section shall be 
awarded on a competitive basis.
    (g) Authorization of Appropriations.--
            (1) In general.--For purposes of carrying out this 
        section, there are authorized to be appropriated 
        $500,000,000 for fiscal year 2010, and such sums as may 
        be necessary for subsequent fiscal years. Funds 
        appropriated under this section shall be available 
        until expended.
            (2) Limitation on use of funds otherwise 
        appropriated.--No funds appropriated under this Act, 
        other than funds appropriated under paragraph (1), may 
        be allocated to the Cures Acceleration Network.

SEC. 403. [283] BIENNIAL REPORTS OF DIRECTOR OF NIH.

    (a) In General.--The Director of NIH shall submit to the 
Congress on a biennial basis a report in accordance with this 
section. The first report shall be submitted not later than 1 
year after the date of the enactment of the National Institutes 
of Health Reform Act of 2006. Each such report shall include 
the following information:
            (1) An assessment of the state of biomedical and 
        behavioral research.
            (2) A description of the activities conducted or 
        supported by the agencies of the National Institutes of 
        Health and policies respecting the programs of such 
        agencies.
            (3) Classification and justification for the 
        priorities established by the agencies, including a 
        strategic plan and recommendations for future research 
        initiatives to be carried out under section 402(b)(7) 
        through the Division of Program Coordination, Planning, 
        and Strategic Initiatives.
            (4) A catalog of all the research activities of the 
        agencies, prepared in accordance with the following:
                    (A) The catalog shall, for each such 
                activity--
                            (i) identify the agency or agencies 
                        involved;
                            (ii) state whether the activity was 
                        carried out directly by the agencies or 
                        was supported by the agencies and 
                        describe to what extent the agency was 
                        involved; and
                            (iii) identify whether the activity 
                        was carried out through a center of 
                        excellence.
                    (B) In the case of clinical research, the 
                catalog shall, as appropriate, identify study 
                populations by demographic variables and other 
                variables that contribute to research on 
                minority health and health disparities.
                    (C) Research activities listed in the 
                catalog shall include, where applicable, the 
                following:
                            (i) Epidemiological studies and 
                        longitudinal studies.
                            (ii) Disease registries, 
                        information clearinghouses, and other 
                        data systems.
                            (iii) Public education and 
                        information campaigns.
                            (iv) Training activities, 
                        including--
                                    (I) National Research 
                                Service Awards and Clinical 
                                Transformation Science Awards;
                                    (II) graduate medical 
                                education programs, including 
                                information on the number and 
                                type of graduate degrees 
                                awarded during the period in 
                                which the programs received 
                                funding under this title;
                                    (III) investigator-
                                initiated awards for 
                                postdoctoral training and 
                                postdoctoral training funded 
                                through research grants;
                                    (IV) a breakdown by 
                                demographic variables and other 
                                appropriate categories; and
                                    (V) an evaluation and 
                                comparison of outcomes and 
                                effectiveness of various 
                                training programs.
                            (v) Clinical trials, including a 
                        breakdown of participation by study 
                        populations and demographic variables 
                        and such other information as may be 
                        necessary to demonstrate compliance 
                        with section 492B (regarding inclusion 
                        of women and minorities in clinical 
                        research).
                            (vi) Translational research 
                        activities with other agencies of the 
                        Public Health Service.
            (5) A summary of the research activities throughout 
        the agencies, which summary shall be organized by the 
        following categories, where applicable:
                    (A) Cancer.
                    (B) Neurosciences.
                    (C) Life stages, human development, and 
                rehabilitation.
                    (D) Organ systems.
                    (E) Autoimmune diseases.
                    (F) Genomics.
                    (G) Molecular biology and basic science.
                    (H) Technology development.
                    (I) Chronic diseases, including pain and 
                palliative care.
                    (J) Infectious diseases and bioterrorism.
                    (K) Minority health and health disparities.
                    (L) Such additional categories as the 
                Director determines to be appropriate.
            (6) A review of each entity receiving funding under 
        this title in its capacity as a center of excellence 
        (in this paragraph referred to as a ``center of 
        excellence''), including the following:
                    (A) An evaluation of the performance and 
                research outcomes of each center of excellence.
                    (B) Recommendations for promoting 
                coordination of information among the centers 
                of excellence.
                    (C) Recommendations for improving the 
                effectiveness, efficiency, and outcomes of the 
                centers of excellence.
                    (D) If no additional centers of excellence 
                have been funded under this title since the 
                previous report under this section, an 
                explanation of the reasons for not funding any 
                additional centers.
    (b) Requirement Regarding Disease-Specific Research 
Activities.--In a report under subsection (a), the Director of 
NIH, when reporting on research activities relating to a 
specific disease, disorder, or other adverse health condition, 
shall--
            (1) present information in a standardized format;
            (2) identify the actual dollar amounts obligated 
        for such activities; and
            (3) include a plan for research on the specific 
        disease, disorder, or other adverse health condition, 
        including a statement of objectives regarding the 
        research, the means for achieving the objectives, a 
        date by which the objectives are expected to be 
        achieved, and justifications for revisions to the plan.
    (c) Additional Reports.--In addition to reports required by 
subsections (a) and (b), the Director of NIH or the head of a 
national research institute or national center may submit to 
the Congress such additional reports as the Director or the 
head of such institute or center determines to be appropriate.

SEC. 403A. [283A] ANNUAL REPORTING TO INCREASE INTERAGENCY 
                    COLLABORATION AND COORDINATION.

    (a) Collaboration With Other HHS Agencies.--On an annual 
basis, the Director of NIH shall submit to the Secretary a 
report on the activities of the National Institutes of Health 
involving collaboration with other agencies of the Department 
of Health and Human Services.
    (b) Clinical Trials.--Each calendar year, the Director of 
NIH shall submit to the Commissioner of Food and Drugs a report 
that identifies each clinical trial that is registered during 
such calendar year in the databank of information established 
under section 402(i).
    (c) Human Tissue Samples.--On an annual basis, the Director 
of NIH shall submit to the Congress a report that describes how 
the National Institutes of Health and its agencies store and 
track human tissue samples.
    (d) First Report.--The first report under subsections (a), 
(b), and (c) shall be submitted not later than 1 year after the 
date of the enactment of the National Institutes of Health 
Reform Act of 2006.

SEC. 403B. [283A-1] ANNUAL REPORTING TO PREVENT FRAUD AND ABUSE.

    (a) Whistleblower Complaints.--
            (1) In general.--On an annual basis, the Director 
        of NIH shall submit to the Inspector General of the 
        Department of Health and Human Services, the Secretary, 
        the Committee on Energy and Commerce and the Committee 
        on Appropriations of the House of Representatives, and 
        the Committee on Health, Education, Labor, and Pensions 
        and the Committee on Appropriations of the Senate a 
        report summarizing the activities of the National 
        Institutes of Health relating to whistleblower 
        complaints.
            (2) Contents.--For each whistleblower complaint 
        pending during the year for which a report is submitted 
        under this subsection, the report shall identify the 
        following:
                    (A) Each agency of the National Institutes 
                of Health involved.
                    (B) The status of the complaint.
                    (C) The resolution of the complaint to 
                date.
    (b) Experts and Consultants.--On an annual basis, the 
Director of NIH shall submit to the Inspector General of the 
Department of Health and Human Services, the Secretary, the 
Committee on Energy and Commerce and the Committee on 
Appropriations of the House of Representatives, and the 
Committee on Health, Education, Labor, and Pensions and the 
Committee on Appropriations of the Senate a report that--
            (1) identifies the number of experts and 
        consultants, including any special consultants, whose 
        services are obtained by the National Institutes of 
        Health or its agencies;
            (2) specifies whether such services were obtained 
        under section 207(f), section 402(d), or other 
        authority;
            (3) describes the qualifications of such experts 
        and consultants;
            (4) describes the need for hiring such experts and 
        consultants; and
            (5) if such experts and consultants make financial 
        disclosures to the National Institutes of Health or any 
        of its agencies, specifies the income, gifts, assets, 
        and liabilities so disclosed.
    (c) First Report.--The first report under subsections (a) 
and (b) shall be submitted not later than 1 year after the date 
of the enactment of the National Institutes of Health Reform 
Act of 2006.

SEC. 403C. [283A-2] ANNUAL REPORTING REGARDING TRAINING OF GRADUATE 
                    STUDENTS FOR DOCTORAL DEGREES.

    (a) In General.--Each institution receiving an award under 
this title for the training of graduate students for doctoral 
degrees shall annually report to the Director of NIH, with 
respect to graduate students supported by the National 
Institutes of Health at such institution--
            (1) the percentage of such students admitted for 
        study who successfully attain a doctoral degree; and
            (2) for students described in paragraph (1), the 
        average time (not including any leaves of absence) 
        between the beginning of graduate study and the receipt 
        of a doctoral degree.
            (3) \1\ Provision of information to applicants.--
        Each institution described in subsection (a) shall 
        provide to each student submitting an application for a 
        program of graduate study at such institution the 
        information described in paragraphs (1) and (2) of such 
        subsection with respect to the program or programs to 
        which such student has applied.
---------------------------------------------------------------------------
    \1\ So in law. Paragraph (3) probably should be subsection (b).
---------------------------------------------------------------------------
                                  des
    Sec. 403D. [283a-3] (a) The Director of NIH shall establish 
a program for the conduct and support of research and training, 
the dissemination of health information, and other programs 
with respect to the diagnosis and treatment of conditions 
associated with exposure to the drug diethylstilbestrol (in 
this section referred to as ``DES'').
    (b) In carrying out subsection (a), the Director of NIH, 
after consultation with nonprofit private entities representing 
individuals who have been exposed to DES, shall conduct or 
support programs to educate health professionals and the public 
on the drug, including the importance of identifying and 
treating individuals who have been exposed to the drug.
    (c) After consultation with the Office of Research on 
Women's Health, the Director of NIH, acting through the 
appropriate national research institutes, shall in carrying out 
subsection (a) conduct or support one or more longitudinal 
studies to determine the incidence of the following diseases or 
disorders in the indicated populations and the relationship of 
DES to the diseases or disorders:
            (1) In the case of women to whom (on or after 
        January 1, 1938) DES was administered while the women 
        were pregnant, the incidence of all diseases and 
        disorders (including breast cancer, gynecological 
        cancers, and impairments of the immune system, 
        including autoimmune disease).
            (2) In the case of women exposed to DES in utero, 
        the incidence of clear cell cancer (including 
        recurrences), the long-term health effects of such 
        cancer, and the effects of treatments for such cancer.
            (3) In the case of men and women exposed to DES in 
        utero, the incidence of all diseases and disorders 
        (including impairments of the reproductive and 
        autoimmune systems).
            (4) In the case of children of men or women exposed 
        to DES in utero, the incidence of all diseases and 
        disorders.
    (d) For purposes of this section, an individual shall be 
considered to have been exposed to DES in utero if, during the 
pregnancy that resulted in the birth of such individual, DES 
was (on or after January 1, 1938) administered to the 
biological mother of the individual.
           office of behavioral and social sciences research
    Sec. 404A. \1\ [283c] (a) There is established within the 
Office of the Director of NIH an office to be known as the 
Office of Behavioral and Social Sciences Research (in this 
section referred to as the ``Office''). The Office shall be 
headed by a director, who shall be appointed by the Director of 
NIH.
---------------------------------------------------------------------------
    \1\ Section 404 was struck by section 101(b)(2) of Public Law 106-
525 (114 Stat. 2501).
---------------------------------------------------------------------------
    (b)(1) With respect to research on the relationship between 
human behavior and the development, treatment, and prevention 
of medical conditions, the Director of the Office shall--
            (A) coordinate research conducted or supported by 
        the agencies of the National Institutes of Health; and
            (B) identify projects of behavioral and social 
        sciences research that should be conducted or supported 
        by the national research institutes, and develop such 
        projects in cooperation with such institutes.
    (2) Research authorized under paragraph (1) includes 
research on teen pregnancy, infant mortality, violent behavior, 
suicide, and homelessness. Such research does not include 
neurobiological research, or research in which the behavior of 
an organism is observed for the purpose of determining activity 
at the cellular or molecular level.
                     children's vaccine initiative
    Sec. 404B. [283d] (a) Development of New Vaccines.--The 
Secretary, in consultation with the Director of the National 
Vaccine Program under title XXI and acting through the 
Directors of the National Institute for Allergy and Infectious 
Diseases, the Eunice Kennedy Shriver National Institute of 
Child Health and Human Development, the National Institute for 
Aging, and other public and private programs, shall carry out 
activities, which shall be consistent with the global 
Children's Vaccine Initiative, to develop affordable new and 
improved vaccines to be used in the United States and in the 
developing world that will increase the efficacy and efficiency 
of the prevention of infectious diseases. In carrying out such 
activities, the Secretary shall, to the extent practicable, 
develop and make available vaccines that require fewer contacts 
to deliver, that can be given early in life, that provide long 
lasting protection, that obviate refrigeration, needles and 
syringes, and that protect against a larger number of diseases.
    (b) Report.--In the report required in section 2104 \1\, 
the Secretary, acting through the Director of the National 
Vaccine Program under title XXI, shall include information with 
respect to activities and the progress made in implementing the 
provisions of this section and achieving its goals.
---------------------------------------------------------------------------
    \1\ Section 2104 was repealed by section 601(a)(1)(H) of Public Law 
105-362 (112 Stat. 3285).
---------------------------------------------------------------------------
          h3  deg.plan for use of animals in research
    Sec. 404C. [283e] (a) The Director of NIH, after 
consultation with the committee established under subsection 
(e), shall prepare a plan--
            (1) for the National Institutes of Health to 
        conduct or support research into--
                    (A) methods of biomedical research and 
                experimentation that do not require the use of 
                animals;
                    (B) methods of such research and 
                experimentation that reduce the number of 
                animals used in such research;
                    (C) methods of such research and 
                experimentation that produce less pain and 
                distress in such animals; and
                    (D) methods of such research and 
                experimentation that involve the use of marine 
                life (other than marine mammals);
            (2) for establishing the validity and reliability 
        of the methods described in paragraph (1);
            (3) for encouraging the acceptance by the 
        scientific community of such methods that have been 
        found to be valid and reliable; and
            (4) for training scientists in the use of such 
        methods that have been found to be valid and reliable.
    (b) Not later than October 1, 1993, the Director of NIH 
shall submit to the Committee on Energy and Commerce of the 
House of Representatives, and to the Committee on Labor and 
Human Resources of the Senate, the plan required in subsection 
(a) and shall begin implementation of the plan.
    (c) The Director of NIH shall periodically review, and as 
appropriate, make revisions in the plan required under 
subsection (a). A description of any revision made in the plan 
shall be included in the first biennial report under section 
403 that is submitted after the revision is made.
    (d) The Director of NIH shall take such actions as may be 
appropriate to convey to scientists and others who use animals 
in biomedical or behavioral research or experimentation 
information respecting the methods found to be valid and 
reliable under subsection (a)(2).
    (e)(1) The Director of NIH shall establish within the 
National Institutes of Health a committee to be known as the 
Interagency Coordinating Committee on the Use of Animals in 
Research (in this subsection referred to as the ``Committee'').
    (2) The Committee shall provide advice to the Director of 
NIH on the preparation of the plan required in subsection (a).
    (3) The Committee shall be composed of--
            (A) the Directors of each of the national research 
        institutes and the Director of the Center for Research 
        Resources (or the designees of such Directors); and
            (B) representatives of the Environmental Protection 
        Agency, the Food and Drug Administration, the Consumer 
        Product Safety Commission, the National Science 
        Foundation, and such additional agencies as the 
        Director of NIH determines to be appropriate, which 
        representatives shall include not less than one 
        veterinarian with expertise in laboratory-animal 
        medicine.
           requirements regarding surveys of sexual behavior
    Sec. 404D. [283f] With respect to any survey of human 
sexual behavior proposed to be conducted or supported through 
the National Institutes of Health, the survey may not be 
carried out unless--
            (1) the proposal has undergone review in accordance 
        with any applicable requirements of sections 491 and 
        492; and
            (2) the Secretary, in accordance with section 492A, 
        makes a determination that the information expected to 
        be obtained through the survey will assist--
                    (A) in reducing the incidence of sexually 
                transmitted diseases, the incidence of 
                infection with the human immunodeficiency 
                virus, or the incidence of any other infectious 
                disease; or
                    (B) in improving reproductive health or 
                other conditions of health.

SEC. 404E. [283G] MUSCULAR DYSTROPHY; INITIATIVE THROUGH DIRECTOR OF 
                    NATIONAL INSTITUTES OF HEALTH.

    (a) Expansion, Intensification, and Coordination of 
Activities.--
            (1) In general.--The Director of NIH, in 
        coordination with the Directors of the National 
        Institute of Neurological Disorders and Stroke, the 
        National Institute of Arthritis and Muscoskeletal and 
        Skin Diseases, the Eunice Kennedy Shriver National 
        Institute of Child Health and Human Development, the 
        National Heart, Lung, and Blood Institute, and the 
        other national research institutes as appropriate, 
        shall expand and intensify programs of such Institutes 
        with respect to research and related activities 
        concerning various forms of muscular dystrophy, 
        including Duchenne, myotonic, facioscapulohumeral 
        muscular dystrophy (referred to in this section as 
        ``FSHD'') and other forms of muscular dystrophy.
            (2) Coordination.--The Directors referred to in 
        paragraph (1) shall jointly coordinate the programs 
        referred to in such paragraph and consult with the 
        Muscular Dystrophy Interagency Coordinating Committee 
        established under section 6 of the MD-CARE Act.
            (3) Allocations by director of nih.--The Director 
        of NIH shall allocate the amounts appropriated to carry 
        out this section for each fiscal year among the 
        national research institutes referred to in paragraph 
        (1).
    (b) Centers of Excellence.--
            (1) In general.--The Director of NIH shall award 
        grants and contracts under subsection (a)(1) to public 
        or nonprofit private entities to pay all or part of the 
        cost of planning, establishing, improving, and 
        providing basic operating support for centers of 
        excellence regarding research on various forms of 
        muscular dystrophy. Such centers of excellence shall be 
        known as the ``Paul D. Wellstone Muscular Dystrophy 
        Cooperative Research Centers''.
            (2) Research.--Each center under paragraph (1) 
        shall supplement but not replace the establishment of a 
        comprehensive research portfolio in all the muscular 
        dystrophies. As a whole, the centers shall conduct 
        basic and clinical research in all forms of muscular 
        dystrophy including early detection, diagnosis, 
        prevention, and treatment, including the fields of 
        muscle biology, genetics, noninvasive imaging, 
        genetics, pharmacological and other therapies.
            (3) Coordination of centers.--The Director of NIH 
        shall, as appropriate, provide for the coordination of 
        information among centers under paragraph (1) and 
        ensure regular communication between such centers.
            (4) Organization of centers.--Each center under 
        paragraph (1) shall use the facilities of a single 
        institution, or be formed from a consortium of 
        cooperating institutions, meeting such requirements as 
        may be prescribed by the Director of NIH.
            (5) Duration of support.--Support for a center 
        established under paragraph (1) may be provided under 
        this section for a period of not to exceed 5 years. 
        Such period may be extended for 1 or more additional 
        periods not exceeding 5 years if the operations of such 
        center have been reviewed by an appropriate technical 
        and scientific peer review group established by the 
        Director of NIH and if such group has recommended to 
        the Director that such period should be extended.
    (c) Facilitation of Research.--The Director of NIH shall 
provide for a program under subsection (a)(1) under which 
samples of tissues and genetic materials that are of use in 
research on muscular dystrophy are donated, collected, 
preserved, and made available for such research. The program 
shall be carried out in accordance with accepted scientific and 
medical standards for the donation, collection, and 
preservation of such samples.
    (d) Coordinating Committee.--
            (1) In general.--The Secretary shall establish the 
        Muscular Dystrophy Coordinating Committee (referred to 
        in this section as the ``Coordinating Committee'') to 
        coordinate activities across the National Institutes 
        and with other Federal health programs and activities 
        relating to the various forms of muscular dystrophy.
            (2) Composition.--The Coordinating Committee shall 
        consist of not more than 15 members to be appointed by 
        the Secretary, of which--
                    (A) \2/3\ of such members shall represent 
                governmental agencies, including the directors 
                or their designees of each of the national 
                research institutes involved in research with 
                respect to muscular dystrophy and 
                representatives of all other Federal 
                departments and agencies whose programs involve 
                health functions or responsibilities relevant 
                to such diseases, including the Centers for 
                Disease Control and Prevention, the Health 
                Resources and Services Administration and the 
                Food and Drug Administration and 
                representatives of other governmental agencies 
                that serve children with muscular dystrophy, 
                such as the Department of Education; and
                    (B) \1/3\ of such members shall be public 
                members, including a broad cross section of 
                persons affected with muscular dystrophies 
                including parents or legal guardians, affected 
                individuals, researchers, and clinicians.
        Members appointed under subparagraph (B) shall serve 
        for a term of 3 years, and may serve for an unlimited 
        number of terms if reappointed.
            (3) Chair.--
                    (A) In general.--With respect to muscular 
                dystrophy, the Chair of the Coordinating 
                Committee shall serve as the principal advisor 
                to the Secretary, the Assistant Secretary for 
                Health, and the Director of NIH, and shall 
                provide advice to the Director of the Centers 
                for Disease Control and Prevention, the 
                Commissioner of Food and Drugs, and to the 
                heads of other relevant agencies. The 
                Coordinating Committee shall select the Chair 
                for a term not to exceed 2 years.
                    (B) Appointment.--The Chair of the 
                Committee shall be appointed by and be directly 
                responsible to the Secretary.
            (4) Administrative support; terms of service; other 
        provisions.--The following shall apply with respect to 
        the Coordinating Committee:
                    (A) The Coordinating Committee shall 
                receive necessary and appropriate 
                administrative support from the Department of 
                Health and Human Services.
                    (B) The Coordinating Committee shall meet 
                as appropriate as determined by the Secretary, 
                in consultation with the chair.
    (e) Plan for HHS Activities.--
            (1) In general.--Not later than 1 year after the 
        date of enactment of this section, the Coordinating 
        Committee shall develop a plan for conducting and 
        supporting research and education on muscular dystrophy 
        through the national research institutes and shall 
        periodically review and revise the plan. The plan 
        shall--
                    (A) provide for a broad range of research 
                and education activities relating to 
                biomedical, epidemiological, psychosocial, and 
                rehabilitative issues, including studies of the 
                impact of such diseases in rural and 
                underserved communities;
                    (B) identify priorities among the programs 
                and activities of the National Institutes of 
                Health regarding such diseases; and
                    (C) reflect input from a broad range of 
                scientists, patients, and advocacy groups.
            (2) Certain elements of plan.--The plan under 
        paragraph (1) shall, with respect to each form of 
        muscular dystrophy, provide for the following as 
        appropriate:
                    (A) Research to determine the reasons 
                underlying the incidence and prevalence of 
                various forms of muscular dystrophy.
                    (B) Basic research concerning the etiology 
                and genetic links of the disease and potential 
                causes of mutations.
                    (C) The development of improved screening 
                techniques.
                    (D) Basic and clinical research for the 
                development and evaluation of new treatments, 
                including new biological agents.
                    (E) Information and education programs for 
                health care professionals and the public.
    (f) Public Input.--The Secretary shall, under subsection 
(a)(1), provide for a means through which the public can obtain 
information on the existing and planned programs and activities 
of the Department of Health and Human Services with respect to 
various forms of muscular dystrophy and through which the 
Secretary can receive comments from the public regarding such 
programs and activities.
    (g) Clinical Research.--The Coordinating Committee may 
evaluate the potential need to enhance the clinical research 
infrastructure required to test emerging therapies for the 
various forms of muscular dystrophy by prioritizing the 
achievement of the goals related to this topic in the plan 
under subsection (e)(1).
                        office of rare diseases
    Sec. 404F. [283h] (a) Establishment.--There is established 
within the Office of the Director of NIH an office to be known 
as the Office of Rare Diseases (in this section referred to as 
the ``Office''), which shall be headed by a Director (in this 
section referred to as the ``Director''), appointed by the 
Director of NIH.
    (b) Duties.--
            (1) In general.--The Director of the Office shall 
        carry out the following:
                    (A) The Director shall recommend an agenda 
                for conducting and supporting research on rare 
                diseases through the national research 
                institutes and centers. The agenda shall 
                provide for a broad range of research and 
                education activities, including scientific 
                workshops and symposia to identify research 
                opportunities for rare diseases.
                    (B) The Director shall, with respect to 
                rare diseases, promote coordination and 
                cooperation among the national research 
                institutes and centers and entities whose 
                research is supported by such institutes.
                    (C) The Director, in collaboration with the 
                directors of the other relevant institutes and 
                centers of the National Institutes of Health, 
                may enter into cooperative agreements with and 
                make grants for regional centers of excellence 
                on rare diseases in accordance with section 
                404G.
                    (D) The Director shall promote the 
                sufficient allocation of the resources of the 
                National Institutes of Health for conducting 
                and supporting research on rare diseases.
                    (E) The Director shall promote and 
                encourage the establishment of a centralized 
                clearinghouse for rare and genetic disease 
                information that will provide understandable 
                information about these diseases to the public, 
                medical professionals, patients and families.
            (2) Principal advisor regarding orphan diseases.--
        With respect to rare diseases, the Director shall serve 
        as the principal advisor to the Director of NIH and 
        shall provide advice to other relevant agencies. The 
        Director shall provide liaison with national and 
        international patient, health and scientific 
        organizations concerned with rare diseases.
    (c) Definition.--For purposes of this section, the term 
``rare disease'' means any disease or condition that affects 
less than 200,000 persons in the United States.
              rare disease regional centers of excellence
    Sec. 404G. [283i] (a) Cooperative Agreements and Grants.--
            (1) In general.--The Director of the Office of Rare 
        Diseases (in this section referred to as the 
        ``Director''), in collaboration with the directors of 
        the other relevant institutes and centers of the 
        National Institutes of Health, may enter into 
        cooperative agreements with and make grants to public 
        or private nonprofit entities to pay all or part of the 
        cost of planning, establishing, or strengthening, and 
        providing basic operating support for regional centers 
        of excellence for clinical research into, training in, 
        and demonstration of diagnostic, prevention, control, 
        and treatment methods for rare diseases.
            (2) Policies.--A cooperative agreement or grant 
        under paragraph (1) shall be entered into in accordance 
        with policies established by the Director of NIH.
    (b) Coordination With Other Institutes.--The Director shall 
coordinate the activities under this section with similar 
activities conducted by other national research institutes, 
centers and agencies of the National Institutes of Health and 
by the Food and Drug Administration to the extent that such 
institutes, centers and agencies have responsibilities that are 
related to rare diseases.
    (c) Uses for Federal Payments Under Cooperative Agreements 
or Grants.--Federal payments made under a cooperative agreement 
or grant under subsection (a) may be used for--
            (1) staffing, administrative, and other basic 
        operating costs, including such patient care costs as 
        are required for research;
            (2) clinical training, including training for 
        allied health professionals, continuing education for 
        health professionals and allied health professions 
        personnel, and information programs for the public with 
        respect to rare diseases; and
            (3) clinical research and demonstration programs.
    (d) Period of Support; Additional Periods.--Support of a 
center under subsection (a) may be for a period of not to 
exceed 5 years. Such period may be extended by the Director for 
additional periods of not more than 5 years if the operations 
of such center have been reviewed by an appropriate technical 
and scientific peer review group established by the Director 
and if such group has recommended to the Director that such 
period should be extended.

SEC. 404H. [283J] REVIEW OF CENTERS OF EXCELLENCE.

    (a) In General.--Not later than April 1, 2008, and 
periodically thereafter, the Secretary, acting through the 
Director of NIH, shall conduct a review and submit a report to 
the appropriate committees of the Congress on the centers of 
excellence.
    (b) Report Contents.--Each report under subsection (a) 
shall include the following:
            (1) Evaluation of the performance and research 
        outcomes of each center of excellence.
            (2) Recommendations for promoting coordination of 
        information among centers of excellence.
            (3) Recommendations for improving the 
        effectiveness, efficiency, and outcomes of the centers 
        of excellence.
    (c) Definition.--In this section, the term ``center of 
excellence'' means an entity receiving funding under this title 
in its capacity as a center of excellence.

   Part B--General Provisions Respecting National Research Institutes

  appointment and authority of the directors of the national research 
                               institutes
    Sec. 405. [284] (a) The Director of the National Cancer 
Institute shall be appointed by the President and the Directors 
of the other national research institutes shall be appointed by 
the Secretary. Each Director of a national research institute 
shall report directly to the Director of NIH.
    (b)(1) In carrying out the purposes of section 301 with 
respect to human diseases or disorders or other aspects of 
human health for which the national research institutes were 
established, the Secretary, acting through the Director of each 
national research institute--
            (A) shall encourage and support research, 
        investigations, experiments, demonstrations, and 
        studies in the health sciences related to--
                    (i) the maintenance of health,
                    (ii) the detection, diagnosis, treatment, 
                and prevention of human diseases and disorders,
                    (iii) the rehabilitation of individuals 
                with human diseases, disorders, and 
                disabilities, and
                    (iv) the expansion of knowledge of the 
                processes underlying human diseases, disorders, 
                and disabilities, the processes underlying the 
                normal and pathological functioning of the body 
                and its organ systems, and the processes 
                underlying the interactions between the human 
                organism and the environment;
            (B) may, subject to the peer review prescribed 
        under section 492(b) and any advisory council review 
        under section 406(a)(3)(A)(i), conduct the research, 
        investigations, experiments, demonstrations, and 
        studies referred to in subparagraph (A);
            (C) may conduct and support research training (i) 
        for which fellowship support is not provided under 
        section 487, and (ii) which is not residency training 
        of physicians or other health professionals;
            (D) may develop, implement, and support 
        demonstrations and programs for the application of the 
        results of the activities of the institute to clinical 
        practice and disease prevention activities;
            (E) may develop, conduct, and support public and 
        professional education and information programs;
            (F) may secure, develop and maintain, distribute, 
        and support the development and maintenance of 
        resources needed for research;
            (G) may make available the facilities of the 
        institute to appropriate entities and individuals 
        engaged in research activities and cooperate with and 
        assist Federal and State agencies charged with 
        protecting the public health;
            (H) may accept unconditional gifts made to the 
        institute for its activities, and, in the case of gifts 
        of a value in excess of $50,000, establish suitable 
        memorials to the donor;
            (I) may secure for the institute consultation 
        services and advice of persons from the United States 
        or abroad;
            (J) may use, with their consent, the services, 
        equipment, personnel, information, and facilities of 
        other Federal, State, or local public agencies, with or 
        without reimbursement therefor;
            (K) may accept voluntary and uncompensated 
        services; and
            (L) may perform such other functions as the 
        Secretary determines are needed to carry out 
        effectively the purposes of the institute.
The indemnification provisions of section 2354, title 10, 
United States Code, shall apply with respect to contracts 
entered into under this subsection and section 402(b).
    (2) Support for an activity or program under this 
subsection may be provided through grants, contracts, and 
cooperative agreements. The Secretary, acting through the 
Director of each national research institute--
            (A) may enter into a contract for research, 
        training, or demonstrations only if the contract has 
        been recommended after technical and scientific peer 
        review required by regulations under section 492;
            (B) may make grants and cooperative agreements 
        under paragraph (1) for research, training, or 
        demonstrations, except that--
                    (i) if the direct cost of the grant or 
                cooperative agreement to be made does not 
                exceed $50,000, such grant or cooperative 
                agreement may be made only if such grant or 
                cooperative agreement has been recommended 
                after technical and scientific peer review 
                required by regulations under section 492, and
                    (ii) if the direct cost of the grant or 
                cooperative agreement to be made exceeds 
                $50,000, such grant or cooperative agreement 
                may be made only if such grant or cooperative 
                agreement has been recommended after technical 
                and scientific peer review required by 
                regulations under section 492 and is 
                recommended under section 406(a)(3)(A)(ii) by 
                the advisory council for the national research 
                institute involved; and
            (C) shall, subject to section 2353(d)(2), receive 
        from the President and the Office of Management and 
        Budget directly all funds appropriated by the Congress 
        for obligation and expenditure by the Institute.
    (c) In carrying out subsection (b), each Director of a 
national research institute--
            (1) shall coordinate, as appropriate, the 
        activities of the institute with similar programs of 
        other public and private entities;
            (2) shall cooperate with the Directors of the other 
        national research institutes in the development and 
        support of multidisciplinary research and research that 
        involves more than one institute;
            (3) may, in consultation with the advisory council 
        for the Institute and with the approval of the Director 
        of NIH--
                    (A) establish technical and scientific peer 
                review groups in addition to those appointed 
                under section 402(b)(16); and
                  (B) appoint the members of peer review groups 
                established under subparagraph (A); and
            (4) may publish, or arrange for the publication of, 
        information with respect to the purpose of the 
        Institute without regard to section 501 of title 44, 
        United States Code.
The Federal Advisory Committee Act shall not apply to the 
duration of a peer review group appointed under paragraph (3).
                           advisory councils
    Sec. 406. [284a] (a)(1) Except as provided in subsection 
(h), the Secretary shall appoint an advisory council for each 
national research institute which (A) shall advise, assist, 
consult with, and make recommendations to the Secretary and the 
Director of such institute on matters related to the activities 
carried out by and through the institute and the policies 
respecting such activities, and (B) shall carry out the special 
functions prescribed by part C.
    (2) Each advisory council for a national research institute 
may recommend to the Secretary acceptance, in accordance with 
section 231, of conditional gifts for study, investigation, or 
research respecting the diseases, disorders, or other aspect of 
human health with respect to which the institute was 
established, for the acquisition of grounds, or for the 
construction, equipping, or maintenance of facilities for the 
institute.
    (3) Each advisory council for a national research 
institute--
            (A)(i) may on the basis of the materials provided 
        under section 492(b)(2) respecting research conducted 
        at the institute, make recommendations to the Director 
        of the institute respecting such research,
            (ii) may review applications for grants and 
        cooperative agreements for research or training and for 
        which advisory council approval is required under 
        section 405(b)(2) and recommend for approval 
        applications for projects which show promise of making 
        valuable contributions to human knowledge, and
            (iii) may review any grant, contract, or 
        cooperative agreement proposed to be made or entered 
        into by the institute;
            (B) may collect, by correspondence or by personal 
        investigation, information as to studies which are 
        being carried on in the United States or any other 
        country as to the diseases, disorders, or other aspect 
        of human health with respect to which the institute was 
        established and with the approval of the Director of 
        the institute make available such information through 
        appropriate publications for the benefit of public and 
        private health entities and health professions 
        personnel and scientists and for the information of the 
        general public; and
            (C) may appoint subcommittees and convene workshops 
        and conferences.
    (b)(1) Each advisory council shall consist of ex officio 
members and not more than eighteen members appointed by the 
Secretary. The ex officio members shall be nonvoting members.
    (2) The ex officio members of an advisory council shall 
consist of--
            (A) the Secretary, the Director of NIH, the 
        Director of the national research institute for which 
        the council is established, the Chief Medical Director 
        of the Department of Veterans Affairs or the Chief 
        Dental Director of the Department of Veterans Affairs, 
        and the Assistant Secretary of Defense for Health 
        Affairs (or the designees of such officers), and
            (B) such additional officers or employees of the 
        United States as the Secretary determines necessary for 
        the advisory council to effectively carry out its 
        functions.
    (3) The members of an advisory council who are not ex 
officio members shall be appointed as follows:
            (A) Two-thirds of the members shall be appointed by 
        the Secretary from among the leading representatives of 
        the health and scientific disciplines (including not 
        less than two individuals who are leaders in the fields 
        of public health and the behavioral or social sciences) 
        relevant to the activities of the national research 
        institute for which the advisory council is 
        established.
            (B) One-third of the members shall be appointed by 
        the Secretary from the general public and shall include 
        leaders in fields of public policy, law, health policy, 
        economics, and management.
    (4) Members of an advisory council who are officers or 
employees of the United States shall not receive any 
compensation for service on the advisory council. The other 
members of an advisory council shall receive, for each day 
(including traveltime) they are engaged in the performance of 
the functions of the advisory council, compensation at rates 
not to exceed the daily equivalent of the annual rate in effect 
for grade GS-18 of the General Schedule.
    (c) The term of office of an appointed member of an 
advisory council is four years, except that any member 
appointed to fill a vacancy for an unexpired term shall be 
appointed for the remainder of such term and the Secretary 
shall make appointments to an advisory council in such a manner 
as to ensure that the terms of the members do not all expire in 
the same year. A member may serve after the expiration of the 
member's term for 180 days after the date of such expiration. A 
member who has been appointed for a term of four years may not 
be reappointed to an advisory council before two years from the 
date of expiration of such term of office. If a vacancy occurs 
in the advisory council among the appointed members, the 
Secretary shall make an appointment to fill the vacancy within 
90 days from the date the vacancy occurs.
    (d) The chairman of an advisory council shall be selected 
by the Secretary from among the appointed members, except that 
the Secretary may select the Director of the national research 
institute for which the advisory council is established to be 
the chairman of the advisory council. The term of office of the 
chairman shall be two years.
    (e) The advisory council shall meet at the call of the 
chairman or upon the request of the Director of the national 
research institute for which it was established, but at least 
three times each fiscal year. The location of the meetings of 
each advisory council is subject to the approval of the 
Director of the national research institute for which the 
advisory council was established.
    (f) The Director of the national research institute for 
which an advisory council is established shall designate a 
member of the staff of the institute to serve as the executive 
secretary of the advisory council. The Director of such 
institute shall make available to the advisory council such 
staff, information, and other assistance as it may require to 
carry out its functions. The Director of such institute shall 
provide orientation and training for new members of the 
advisory council to provide them with such information and 
training as may be appropriate for their effective 
participation in the functions of the advisory council.
    (g) Each advisory council may prepare, for inclusion in the 
biennial report made under section 407, (1) comments respecting 
the activities of the advisory council in the fiscal years 
respecting which the report is prepared, (2) comments on the 
progress of the national research institute for which it was 
established in meeting its objectives, and (3) recommendations 
respecting the future directions and program and policy 
emphasis of the institute. Each advisory council may prepare 
such additional reports as it may determine appropriate.
    (h)(1) Except as provided in paragraph (2), this section 
does not terminate the membership of any advisory council for a 
national research institute which was in existence on the date 
of enactment of the Health Research Extension Act of 1985. 
After such date--
            (A) the Secretary shall make appointments to each 
        such advisory council in such a manner as to bring 
        about as soon as practicable the composition for such 
        council prescribed by this section;
            (B) each advisory council shall organize itself in 
        accordance with this section and exercise the functions 
        prescribed by this section; and
            (C) the Director of each national research 
        institute shall perform for such advisory council the 
        functions prescribed by this section.
    (2)(A) The National Cancer Advisory Board shall be the 
advisory council for the National Cancer Institute. This 
section applies to the National Cancer Advisory Board, except 
that--
            (i) appointments to such Board shall be made by the 
        President;
            (ii) the term of office of an appointed member 
        shall be 6 years;
            (iii) of the members appointed to the Board not 
        less than five members shall be individuals 
        knowledgeable in environmental carcinogenesis 
        (including carcinogenesis involving occupational and 
        dietary factors);
            (iv) the chairman of the Board shall be selected by 
        the President from the appointed members and shall 
        serve as chairman for a term of two years;
            (v) the ex officio members of the Board shall be 
        nonvoting members and shall be the Secretary, the 
        Director of the Office of Science and Technology 
        Policy, the Director of NIH, the Chief Medical Director 
        of the Department of Veterans Affairs, the Director of 
        the National Institute for Occupational Safety and 
        Health, the Director of the National Institute of 
        Environmental Health Sciences, the Secretary of Labor, 
        the Commissioner of the Food and Drug Administration, 
        the Administrator of the Environmental Protection 
        Agency, the Chairman of the Consumer Product Safety 
        Commission, the Assistant Secretary of Defense for 
        Health Affairs, and the Director of the Office of 
        Science of the Department of Energy (or the designees 
        of such officers); and
            (vi) the Board shall meet at least four times each 
        fiscal year.
    (B) This section applies to the advisory council to the 
National Heart, Lung, and Blood Institute, except that the 
advisory council shall meet at least four times each fiscal 
year. \1\
---------------------------------------------------------------------------
    \1\ Section 407 of the Public Health Service Act was repealed by 
section 104(b)(1)(C) of Public Law 109-482 (120 Stat. 3693).
---------------------------------------------------------------------------
                         certain uses of funds
    Sec. 408. [284c] (a)(1) Except as provided in paragraph 
(2), the sum of the amounts obligated in any fiscal year for 
administrative expenses of the National Institutes of Health 
may not exceed an amount which is 5.5 percent of the total 
amount appropriated for such fiscal year for the National 
Institutes of Health.
    (2) Paragraph (1) does not apply to the National Library of 
Medicine, the National Center for Nursing Research, \1\ the 
John E. Fogarty International Center for Advanced Study in the 
Health Sciences, the Warren G. Magnuson Clinical Center, and 
the Office of Medical Applications of Research.
---------------------------------------------------------------------------
    \1\ See footnote 2 for section 403(5).
---------------------------------------------------------------------------
    (3) For purposes of paragraph (1), the term 
``administrative expenses'' means expenses incurred for the 
support of activities relevant to the award of grants, 
contracts, and cooperative agreements and expenses incurred for 
general administration of the scientific programs and 
activities of the National Institutes of Health.
    (b) For fiscal year 1989 and subsequent fiscal years, 
amounts made available to the National Institutes of Health 
shall be available for payment of nurses and allied health 
professionals in accordance with payment authorities, 
scheduling options, benefits, and other authorities provided 
under chapter 73 of title 38, United States Code, for nurses of 
the Department of Veterans Affairs.
                              definitions
    Sec. 409. [284d] (a) Health Service Research.--For purposes 
of this title, the term ``health services research'' means 
research endeavors that study the impact of the organization, 
financing and management of health services on the quality, 
cost, access to and outcomes of care. Such term does not 
include research on the efficacy of services to prevent, 
diagnose, or treat medical conditions.
    (b) Clinical Research.--As used in this title, the term 
``clinical research'' means patient oriented clinical research 
conducted with human subjects, or research on the causes and 
consequences of disease in human populations involving material 
of human origin (such as tissue specimens and cognitive 
phenomena) for which an investigator or colleague directly 
interacts with human subjects in an outpatient or inpatient 
setting to clarify a problem in human physiology, 
pathophysiology or disease, or epidemiologic or behavioral 
studies, outcomes research or health services research, or 
developing new technologies, therapeutic interventions, or 
clinical trials.
 research on osteoporosis, paget's disease, and related bone disorders
    Sec. 409A. [284e] (a) Establishment.--The Directors of the 
National Institute of Arthritis and Musculoskeletal and Skin 
Diseases, the National Institute on Aging, the National 
Institute of Dental Research, \1\ and the National Institute of 
Diabetes and Digestive and Kidney Diseases, shall expand and 
intensify the programs of such Institutes with respect to 
research and related activities concerning osteoporosis, 
Paget's disease, and related bone disorders.
---------------------------------------------------------------------------
    \1\See footnote for section 401(b)(1)(H).
---------------------------------------------------------------------------
    (b) Coordination.--The Directors referred to in subsection 
(a) shall jointly coordinate the programs referred to in such 
subsection and consult with the Arthritis and Musculoskeletal 
Diseases Interagency Coordinating Committee and the Interagency 
Task Force on Aging Research.
    (c) Information Clearinghouse.--
            (1) In general.--In order to assist in carrying out 
        the purpose described in subsection (a), the Director 
        of NIH shall provide for the establishment of an 
        information clearinghouse on osteoporosis and related 
        bone disorders to facilitate and enhance knowledge and 
        understanding on the part of health professionals, 
        patients, and the public through the effective 
        dissemination of information.
            (2) Establishment through grant or contract.--For 
        the purpose of carrying out paragraph (1), the Director 
        of NIH shall enter into a grant, cooperative agreement, 
        or contract with a nonprofit private entity involved in 
        activities regarding the prevention and control of 
        osteoporosis and related bone disorders.
                          parkinson's disease
    Sec. 409B. [42 U.S.C. 284f] (a) In General.--The Director 
of NIH shall establish a program for the conduct and support of 
research and training with respect to Parkinson's disease 
(subject to the extent of amounts appropriated to carry out 
this section).
    (b) Inter-Institute Coordination.--
            (1) In general.--The Director of NIH shall provide 
        for the coordination of the program established under 
        subsection (a) among all of the national research 
        institutes conducting Parkinson's disease research.
            (2) Conference.--Coordination under paragraph (1) 
        shall include the convening of a research planning 
        conference not less frequently than once every 2 years. 
        Each such conference shall prepare and submit to the 
        Committee on Appropriations and the Committee on Labor 
        and Human Resources of the Senate and the Committee on 
        Appropriations and the Committee on Commerce of the 
        House of Representatives a report concerning the 
        conference.
    (c) Morris K. Udall Research Centers.--
            (1) In general.--The Director of NIH is authorized 
        to award Core Center Grants to encourage the 
        development of innovative multidisciplinary research 
        and provide training concerning Parkinson's disease. 
        The Director is authorized to award not more than 10 
        Core Center Grants and designate each center funded 
        under such grants as a Morris K. Udall Center for 
        Research on Parkinson's Disease.
            (2) Requirements.--
                    (A) In general.--With respect to 
                Parkinson's disease, each center assisted under 
                this subsection shall--
                            (i) use the facilities of a single 
                        institution or a consortium of 
                        cooperating institutions, and meet such 
                        qualifications as may be prescribed by 
                        the Director of the NIH; and
                            (ii) conduct basic and clinical 
                        research.
                    (B) Discretionary requirements.--With 
                respect to Parkinson's disease, each center 
                assisted under this subsection may--
                            (i) conduct training programs for 
                        scientists and health professionals;
                            (ii) conduct programs to provide 
                        information and continuing education to 
                        health professionals;
                            (iii) conduct programs for the 
                        dissemination of information to the 
                        public;
                            (iv) separately or in collaboration 
                        with other centers, establish a 
                        nationwide data system derived from 
                        patient populations with Parkinson's 
                        disease, and where possible, comparing 
                        relevant data involving general 
                        populations;
                            (v) separately or in collaboration 
                        with other centers, establish a 
                        Parkinson's Disease Information 
                        Clearinghouse to facilitate and enhance 
                        knowledge and understanding of 
                        Parkinson's disease; and
                            (vi) separately or in collaboration 
                        with other centers, establish a 
                        national education program that fosters 
                        a national focus on Parkinson's disease 
                        and the care of those with Parkinson's 
                        disease.
            (3) Stipends regarding training programs.--A center 
        may use funds provided under paragraph (1) to provide 
        stipends for scientists and health professionals 
        enrolled in training programs under paragraph (2)(B).
            (4) Duration of support.--Support of a center under 
        this subsection may be for a period not exceeding five 
        years. Such period may be extended by the Director of 
        NIH for one or more additional periods of not more than 
        five years if the operations of such center have been 
        reviewed by an appropriate technical and scientific 
        peer review group established by the Director and if 
        such group has recommended to the Director that such 
        period should be extended.
    (d) Morris K. Udall Awards for Excellence in Parkinson's 
Disease Research.--The Director of NIH is authorized to 
establish a grant program to support investigators with a 
proven record of excellence and innovation in Parkinson's 
disease research and who demonstrate potential for significant 
future breakthroughs in the understanding of the pathogensis, 
diagnosis, and treatment of Parkinson's disease. Grants under 
this subsection shall be available for a period of not to 
exceed 5 years.
expansion, intensification, and coordination of activities of national 
   institutes of health with respect to research on autism spectrum 
                              disorder \1\
---------------------------------------------------------------------------
    \1\ Title I of Public Law 106-310 (114 Stat. 1105) established 
several programs regarding autism, including the program under section 
409C above. Section 105 of the Public Law requires annual reports to 
the Congress on the implementation of such title I and the amendments 
made by the title.
---------------------------------------------------------------------------
    Sec. 409C. [284g] (a) In General.--
            (1) Expansion of activities.--The Director of NIH 
        (in this section referred to as the ``Director'') 
        shall, subject to the availability of appropriations, 
        expand, intensify, and coordinate the activities of the 
        National Institutes of Health with respect to research 
        on autism spectrum disorder, including basic and 
        clinical research in fields including pathology, 
        developmental neurobiology, genetics, epigenetics, 
        pharmacology, nutrition, immunology, neuroimmunology, 
        neurobehavioral development, endocrinology, 
        gastroenterology, and toxicology. Such research shall 
        investigate the cause (including possible environmental 
        causes), diagnosis or rule out, early detection, 
        prevention, services, supports, intervention, and 
        treatment of autism spectrum disorder.
            (2) Consolidation.--The Director may consolidate 
        program activities under this section if such 
        consolidation would improve program efficiencies and 
        outcomes.
            (3) Administration of program; collaboration among 
        agencies.--The Director shall carry out this section 
        acting through the Director of the National Institute 
        of Mental Health and in collaboration with any other 
        agencies that the Director determines appropriate.
    (b) Centers of Excellence.--
            (1) In general.--The Director shall under 
        subsection (a)(1) make awards of grants and contracts 
        to public or nonprofit private entities to pay all or 
        part of the cost of planning, establishing, improving, 
        and providing basic operating support for centers of 
        excellence regarding research on autism spectrum 
        disorder.
            (2) Research.--Each center under paragraph (1) 
        shall conduct basic and clinical research into autism 
        spectrum disorder. Such research should include 
        investigations into the cause, diagnosis, early 
        detection, prevention, control, and treatment of autism 
        spectrum disorder. The centers, as a group, shall 
        conduct research including the fields of developmental 
        neurobiology, genetics, and psychopharmacology.
            (3) Services for patients.--
                    (A) In general.--A center under paragraph 
                (1) may expend amounts provided under such 
                paragraph to carry out a program to make 
                individuals aware of opportunities to 
                participate as subjects in research conducted 
                by the centers.
                    (B) Referrals and costs.--A program under 
                subparagraph (A) may, in accordance with such 
                criteria as the Director may establish, provide 
                to the subjects described in such subparagraph, 
                referrals for health and other services, and 
                such patient care costs as are required for 
                research.
                    (C) Availability and access.--The extent to 
                which a center can demonstrate availability and 
                access to clinical services shall be considered 
                by the Director in decisions about awarding 
                grants to applicants which meet the scientific 
                criteria for funding under this section.
            (4) Organization of centers.--Each center under 
        paragraph (1) shall use the facilities of a single 
        institution, or be formed from a consortium of 
        cooperating institutions, meeting such requirements as 
        may be prescribed by the Director.
            (5) Number of centers; duration of support.--
                    (A) In general.--The Director shall provide 
                for the establishment of not less than five 
                centers under paragraph (1).
                    (B) Duration.--Support for a center 
                established under paragraph (1) may be provided 
                under this section for a period of not to 
                exceed 5 years. Such period may be extended for 
                one or more additional periods not exceeding 5 
                years if the operations of such center have 
                been reviewed by an appropriate technical and 
                scientific peer review group established by the 
                Director and if such group has recommended to 
                the Director that such period should be 
                extended.
    (c) Facilitation of Research.--The Director shall under 
subsection (a)(1) provide for a program under which samples of 
tissues and genetic materials that are of use in research on 
autism spectrum disorder are donated, collected, preserved, and 
made available for such research. The program shall be carried 
out in accordance with accepted scientific and medical 
standards for the donation, collection, and preservation of 
such samples.
    (d) Public Input.--The Director shall under subsection 
(a)(1) provide for means through which the public can obtain 
information on the existing and planned programs and activities 
of the National Institutes of Health with respect to autism 
spectrum disorder and through which the Director can receive 
comments from the public regarding such programs and 
activities.
                     pediatric research initiative
    Sec. 409D. [284h] (a) Establishment.--The Secretary shall 
establish within the Office of the Director of NIH a Pediatric 
Research Initiative (referred to in this section as the 
``Initiative'') to conduct and support research that is 
directly related to diseases, disorders, and other conditions 
in children. The Initiative shall be headed by the Director of 
NIH.
    (b) Purpose.--The purpose of the Initiative is to provide 
funds to enable the Director of NIH--
            (1) to increase support for pediatric biomedical 
        research within the National Institutes of Health to 
        realize the expanding opportunities for advancement in 
        scientific investigations and care for children;
            (2) to enhance collaborative efforts among the 
        Institutes to conduct and support multidisciplinary 
        research in the areas that the Director deems most 
        promising; and
            (3) in coordination with the Food and Drug 
        Administration, to increase the development of adequate 
        pediatric clinical trials and pediatric use information 
        to promote the safer and more effective use of 
        prescription drugs in the pediatric population.
    (c) Duties.--In carrying out subsection (b), the Director 
of NIH shall--
            (1) consult with the Director of the Eunice Kennedy 
        Shriver National Institute of Child Health and Human 
        Development and the other national research institutes, 
        in considering their requests for new or expanded 
        pediatric research efforts, and consult with the 
        Administrator of the Health Resources and Services 
        Administration and other advisors as the Director 
        determines to be appropriate;
            (2) have broad discretion in the allocation of any 
        Initiative assistance among the Institutes, among types 
        of grants, and between basic and clinical research so 
        long as the assistance is directly related to the 
        illnesses and conditions of children; and
            (3) be responsible for the oversight of any newly 
        appropriated Initiative funds and annually report to 
        Congress and the public on the extent of the total 
        funds obligated to conduct or support pediatric 
        research across the National Institutes of Health, 
        including the specific support and research awards 
        allocated through the Initiative.
    (d) Transfer of Funds.--The Director of NIH may transfer 
amounts appropriated under this section to any of the 
Institutes for a fiscal year to carry out the purposes of the 
Initiative under this section.

SEC. 409E. [284I] AUTOIMMUNE DISEASES.

    (a) Expansion, Intensification, and Coordination of 
Activities.--
            (1) In general.--The Director of NIH shall expand, 
        intensify, and coordinate research and other activities 
        of the National Institutes of Health with respect to 
        autoimmune diseases.
            (2) Allocations by director of nih.--With respect 
        to amounts appropriated to carry out this section for a 
        fiscal year, the Director of NIH shall allocate the 
        amounts among the national research institutes that are 
        carrying out paragraph (1).
            (3) Definition.--The term ``autoimmune disease'' 
        includes, for purposes of this section such diseases or 
        disorders with evidence of autoimmune pathogensis as 
        the Secretary determines to be appropriate.
    (b) Coordinating Committee.--
            (1) In general.--The Secretary shall ensure that 
        the Autoimmune Diseases Coordinating Committee 
        (referred to in this section as the ``Coordinating 
        Committee'') coordinates activities across the National 
        Institutes and with other Federal health programs and 
        activities relating to such diseases.
            (2) Composition.--The Coordinating Committee shall 
        be composed of the directors or their designees of each 
        of the national research institutes involved in 
        research with respect to autoimmune diseases and 
        representatives of all other Federal departments and 
        agencies whose programs involve health functions or 
        responsibilities relevant to such diseases, including 
        the Centers for Disease Control and Prevention and the 
        Food and Drug Administration.
            (3) Chair.--
                    (A) In general.--With respect to autoimmune 
                diseases, the Chair of the Committee shall 
                serve as the principal advisor to the 
                Secretary, the Assistant Secretary for Health, 
                and the Director of NIH, and shall provide 
                advice to the Director of the Centers for 
                Disease Control and Prevention, the 
                Commissioner of Food and Drugs, and other 
                relevant agencies.
                    (B) Director of nih.--The Chair of the 
                Committee shall be directly responsible to the 
                Director of NIH.
    (c) Plan for NIH Activities.--
            (1) In general.--Not later than 1 year after the 
        date of the enactment of this section, the Coordinating 
        Committee shall develop a plan for conducting and 
        supporting research and education on autoimmune 
        diseases through the national research institutes and 
        shall periodically review and revise the plan. The plan 
        shall--
                    (A) provide for a broad range of research 
                and education activities relating to 
                biomedical, psychosocial, and rehabilitative 
                issues, including studies of the 
                disproportionate impact of such diseases on 
                women;
                    (B) identify priorities among the programs 
                and activities of the National Institutes of 
                Health regarding such diseases; and
                    (C) reflect input from a broad range of 
                scientists, patients, and advocacy groups.
            (2) Certain elements of plan.--The plan under 
        paragraph (1) shall, with respect to autoimmune 
        diseases, provide for the following as appropriate:
                    (A) Research to determine the reasons 
                underlying the incidence and prevalence of the 
                diseases.
                    (B) Basic research concerning the etiology 
                and causes of the diseases.
                    (C) Epidemiological studies to address the 
                frequency and natural history of the diseases, 
                including any differences among the sexes and 
                among racial and ethnic groups.
                    (D) The development of improved screening 
                techniques.
                    (E) Clinical research for the development 
                and evaluation of new treatments, including new 
                biological agents.
                    (F) Information and education programs for 
                health care professionals and the public.
            (3) Implementation of plan.--The Director of NIH 
        shall ensure that programs and activities of the 
        National Institutes of Health regarding autoimmune 
        diseases are implemented in accordance with the plan 
        under paragraph (1).
                      muscular dystrophy research
    Sec. 409F. [284j] (a) Coordination of Activities.--The 
Director of NIH shall expand and increase coordination in the 
activities of the National Institutes of Health with respect to 
research on muscular dystrophies, including Duchenne muscular 
dystrophy.
    (b) Administration of Program; Collaboration Among 
Agencies.--The Director of NIH shall carry out this section 
through the appropriate institutes, including the National 
Institute of Neurological Disorders and Stroke and in 
collaboration with any other agencies that the Director 
determines appropriate.

SEC. 409G. [284K] CLINICAL RESEARCH.

    (a) In General.--The Director of National Institutes of 
Health shall undertake activities to support and expand the 
involvement of the National Institutes of Health in clinical 
research.
    (b) Requirements.--In carrying out subsection (a), the 
Director of National Institutes of Health shall--
            (1) consider the recommendations of the Division of 
        Research Grants Clinical Research Study Group and other 
        recommendations for enhancing clinical research; and
            (2) establish intramural and extramural clinical 
        research fellowship programs directed specifically at 
        medical and dental students and a continuing education 
        clinical research training program at the National 
        Institutes of Health.
    (c) Support for the Diverse Needs of Clinical Research.--
The Director of National Institutes of Health, in cooperation 
with the Directors of the Institutes, Centers, and Divisions of 
the National Institutes of Health, shall support and expand the 
resources available for the diverse needs of the clinical 
research community, including inpatient, outpatient, and 
critical care clinical research.
    (d) Peer Review.--The Director of National Institutes of 
Health shall establish peer review mechanisms to evaluate 
applications for the awards and fellowships provided for in 
subsection (b)(2) and section 409D. Such review mechanisms 
shall include individuals who are exceptionally qualified to 
appraise the merits of potential clinical research training and 
research grant proposals.

SEC. 409H. [284L] ENHANCEMENT AWARDS.

    (a) Mentored Patient-Oriented Research Career Development 
Awards.--
            (1) Grants.--
                    (A) In general.--The Director of the 
                National Institutes of Health shall make grants 
                (to be referred to as ``Mentored Patient-
                Oriented Research Career Development Awards'') 
                to support individual careers in clinical 
                research at general clinical research centers 
                or at other institutions that have the 
                infrastructure and resources deemed appropriate 
                for conducting patient-oriented clinical 
                research.
                    (B) Use.--Grants under subparagraph (A) 
                shall be used to support clinical investigators 
                in the early phases of their independent 
                careers by providing salary and such other 
                support for a period of supervised study.
            (2) Applications.--An application for a grant under 
        this subsection shall be submitted by an individual 
        scientist at such time as the Director may require.
    (b) Mid-Career Investigator Awards in Patient-Oriented 
Research.--
            (1) Grants.--
                    (A) In general.--The Director of the 
                National Institutes of Health shall make grants 
                (to be referred to as ``Mid-Career Investigator 
                Awards in Patient-Oriented Research'') to 
                support individual clinical research projects 
                at general clinical research centers or at 
                other institutions that have the infrastructure 
                and resources deemed appropriate for conducting 
                patient-oriented clinical research.
                    (B) Use.--Grants under subparagraph (A) 
                shall be used to provide support for mid-career 
                level clinicians to allow such clinicians to 
                devote time to clinical research and to act as 
                mentors for beginning clinical investigators.
            (2) Applications.--An application for a grant under 
        this subsection shall be submitted by an individual 
        scientist at such time as the Director requires.
    (c) Graduate Training in Clinical Investigation Award.--
            (1) In general.--The Director of the National 
        Institutes of Health shall make grants (to be referred 
        to as ``Graduate Training in Clinical Investigation 
        Awards'') to support individuals pursuing master's or 
        doctoral degrees in clinical investigation.
            (2) Applications.--An application for a grant under 
        this subsection shall be submitted by an individual 
        scientist at such time as the Director may require.
            (3) Limitations.--Grants under this subsection 
        shall be for terms of 2 years or more and shall provide 
        stipend, tuition, and institutional support for 
        individual advanced degree programs in clinical 
        investigation.
            (4) Definition.--As used in this subsection, the 
        term ``advanced degree programs in clinical 
        investigation'' means programs that award a master's or 
        Ph.D. degree in clinical investigation after 2 or more 
        years of training in areas such as the following:
                    (A) Analytical methods, biostatistics, and 
                study design.
                    (B) Principles of clinical pharmacology and 
                pharmacokinetics.
                    (C) Clinical epidemiology.
                    (D) Computer data management and medical 
                informatics.
                    (E) Ethical and regulatory issues.
                    (F) Biomedical writing.
    (d) Clinical Research Curriculum Awards.--
            (1) In general.--The Director of the National 
        Institutes of Health shall make grants (to be referred 
        to as ``Clinical Research Curriculum Awards'') to 
        institutions for the development and support of 
        programs of core curricula for training clinical 
        investigators, including medical students. Such core 
        curricula may include training in areas such as the 
        following:
                    (A) Analytical methods, biostatistics, and 
                study design.
                    (B) Principles of clinical pharmacology and 
                pharmacokinetics.
                    (C) Clinical epidemiology.
                    (D) Computer data management and medical 
                informatics.
                    (E) Ethical and regulatory issues.
                    (F) Biomedical writing.
            (2) Applications.--An application for a grant under 
        this subsection shall be submitted by an individual 
        institution or a consortium of institutions at such 
        time as the Director may require. An institution may 
        submit only one such application.
            (3) Limitations.--Grants under this subsection 
        shall be for terms of up to 5 years and may be 
        renewable.

SEC. 409I. [284M] PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. \1\
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    \1\ Section 16 of Public Law 107-109 (115 Stat. 1421) requires the 
Comptroller General of the United States, in consultation with the 
Secretary of Health and Human Services, to submit to Congress a report 
that relates to section 409I and to section 505A of the Federal Food, 
Drug, and Cosmetic Act. The report is required to be submitted not 
later than October 1, 2006.
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    (a) List of Priority Issues in Pediatric Therapeutics.--
            (1) In general.--Not later than one year after the 
        date of the enactment of the Best Pharmaceuticals for 
        Children Act of 2007, the Secretary, acting through the 
        Director of the National Institutes of Health and in 
        consultation with the Commissioner of Food and Drugs 
        and experts in pediatric research, shall develop and 
        publish a priority list of needs in pediatric 
        therapeutics, including drugs, biological products, or 
        indications that require study. The list shall be 
        revised every three years.
            (2) Consideration of available information.--In 
        developing and prioritizing the list under paragraph 
        (1), the Secretary shall consider--
                    (A) therapeutic gaps in pediatrics that may 
                include developmental pharmacology, 
                pharmacogenetic determinants of drug response, 
                metabolism of drugs and biologics in children, 
                and pediatric clinical trials;
                    (B) particular pediatric diseases, 
                disorders or conditions where more complete 
                knowledge and testing of therapeutics, 
                including drugs and biologics, may be 
                beneficial in pediatric populations; and
                    (C) the adequacy of necessary 
                infrastructure to conduct pediatric 
                pharmacological research, including research 
                networks and trained pediatric investigators.
    (b) Pediatric Studies and Research.--The Secretary, acting 
through the National Institutes of Health, shall award funds to 
entities that have the expertise to conduct pediatric clinical 
trials or other research (including qualified universities, 
hospitals, laboratories, contract research organizations, 
practice groups, federally funded programs such as pediatric 
pharmacology research units, other public or private 
institutions, or individuals) to enable the entities to conduct 
the drug studies or other research on the issues described in 
subsection (a). The Secretary may use contracts, grants, or 
other appropriate funding mechanisms to award funds under this 
subsection.
    (c) Process for Proposed Pediatric Study Requests and 
Labeling Changes.--
            (1) Submission of proposed pediatric study 
        request.--The Director of the National Institutes of 
        Health shall, as appropriate, submit proposed pediatric 
        study requests for consideration by the Commissioner of 
        Food and Drugs for pediatric studies of a specific 
        pediatric indication identified under subsection (a). 
        Such a proposed pediatric study request shall be made 
        in a manner equivalent to a written request made under 
        subsection (b) or (c) of section 505A of the Federal 
        Food, Drug, and Cosmetic Act, including with respect to 
        the information provided on the pediatric studies to be 
        conducted pursuant to the request. The Director of the 
        National Institutes of Health may submit a proposed 
        pediatric study request for a drug for which--
                    (A)(i) there is an approved application 
                under section 505(j) of the Federal Food, Drug, 
                and Cosmetic Act; or
                    (ii) there is a submitted application that 
                could be approved under the criteria of such 
                section; and
                    (B) there is no patent protection or market 
                exclusivity protection for at least one form of 
                the drug under the Federal Food, Drug, and 
                Cosmetic Act; and
                    (C) additional studies are needed to assess 
                the safety and effectiveness of the use of the 
                drug in the pediatric population.
            (2) Written request to holders of approved 
        applications for drugs lacking exclusivity.--The 
        Commissioner of Food and Drugs, in consultation with 
        the Director of the National Institutes of Health, may 
        issue a written request based on the proposed pediatric 
        study request for the indication or indications 
        submitted pursuant to paragraph (1) (which shall 
        include a timeframe for negotiations for an agreement) 
        for pediatric studies concerning a drug identified 
        under subsection (a) to all holders of an approved 
        application for the drug under section 505 of the 
        Federal Food, Drug, and Cosmetic Act. Such a written 
        request shall be made in a manner equivalent to the 
        manner in which a written request is made under 
        subsection (b) or (c) of section 505A of such Act, 
        including with respect to information provided on the 
        pediatric studies to be conducted pursuant to the 
        request and using appropriate formulations for each age 
        group for which the study is requested.
            (3) Requests for proposals.--If the Commissioner of 
        Food and Drugs does not receive a response to a written 
        request issued under paragraph (2) not later than 30 
        days after the date on which a request was issued, the 
        Secretary, acting through the Director of the National 
        Institutes of Health and in consultation with the 
        Commissioner of Food and Drugs, shall publish a request 
        for proposals to conduct the pediatric studies 
        described in the written request in accordance with 
        subsection (b).
            (4) Disqualification.--A holder that receives a 
        first right of refusal shall not be entitled to respond 
        to a request for proposals under paragraph (3).
            (5) Contracts, grants, or other funding 
        mechanisms.--A contract, grant, or other funding may be 
        awarded under this section only if a proposal is 
        submitted to the Secretary in such form and manner, and 
        containing such agreements, assurances, and information 
        as the Secretary determines to be necessary to carry 
        out this section.
            (6) Reporting of studies.--
                    (A) In general.--On completion of a 
                pediatric study in accordance with an award 
                under this section, a report concerning the 
                study shall be submitted to the Director of the 
                National Institutes of Health and the 
                Commissioner of Food and Drugs. The report 
                shall include all data generated in connection 
                with the study, including a written request if 
                issued.
                    (B) Availability of reports.--Each report 
                submitted under subparagraph (A) shall be 
                considered to be in the public domain (subject 
                to section 505A(d)(4) of the Federal Food, 
                Drug, and Cosmetic Act) and shall be assigned a 
                docket number by the Commissioner of Food and 
                Drugs. An interested person may submit written 
                comments concerning such pediatric studies to 
                the Commissioner of Food and Drugs, and the 
                written comments shall become part of the 
                docket file with respect to each of the drugs.
                    (C) Action by commissioner.--The 
                Commissioner of Food and Drugs shall take 
                appropriate action in response to the reports 
                submitted under subparagraph (A) in accordance 
                with paragraph (7).
            (7) Requests for labeling change.--During the 180-
        day period after the date on which a report is 
        submitted under paragraph (6)(A), the Commissioner of 
        Food and Drugs shall--
                    (A) review the report and such other data 
                as are available concerning the safe and 
                effective use in the pediatric population of 
                the drug studied;
                    (B) negotiate with the holders of approved 
                applications for the drug studied for any 
                labeling changes that the Commissioner of Food 
                and Drugs determines to be appropriate and 
                requests the holders to make; and
                    (C)(i) place in the public docket file a 
                copy of the report and of any requested 
                labeling changes; and
                    (ii) publish in the Federal Register and 
                through a posting on the Web site of the Food 
                and Drug Administration a summary of the report 
                and a copy of any requested labeling changes.
            (8) Dispute resolution.--
                    (A) Referral to pediatric advisory 
                committee.--If, not later than the end of the 
                180-day period specified in paragraph (7), the 
                holder of an approved application for the drug 
                involved does not agree to any labeling change 
                requested by the Commissioner of Food and Drugs 
                under that paragraph, the Commissioner of Food 
                and Drugs shall refer the request to the 
                Pediatric Advisory Committee.
                    (B) Action by the pediatric advisory 
                committee.--Not later than 90 days after 
                receiving a referral under subparagraph (A), 
                the Pediatric Advisory Committee shall--
                            (i) review the available 
                        information on the safe and effective 
                        use of the drug in the pediatric 
                        population, including study reports 
                        submitted under this section; and
                            (ii) make a recommendation to the 
                        Commissioner of Food and Drugs as to 
                        appropriate labeling changes, if any.
            (9) FDA determination.--Not later than 30 days 
        after receiving a recommendation from the Pediatric 
        Advisory Committee under paragraph (8)(B)(ii) with 
        respect to a drug, the Commissioner of Food and Drugs 
        shall consider the recommendation and, if appropriate, 
        make a request to the holders of approved applications 
        for the drug to make any labeling change that the 
        Commissioner of Food and Drugs determines to be 
        appropriate.
            (10) Failure to agree.--If a holder of an approved 
        application for a drug, within 30 days after receiving 
        a request to make a labeling change under paragraph 
        (9), does not agree to make a requested labeling 
        change, the Commissioner of Food and Drugs may deem the 
        drug to be misbranded under the Federal Food, Drug, and 
        Cosmetic Act.
            (11) No effect on authority.--Nothing in this 
        subsection limits the authority of the United States to 
        bring an enforcement action under the Federal Food, 
        Drug, and Cosmetic Act when a drug lacks appropriate 
        pediatric labeling. Neither course of action (the 
        Pediatric Advisory Committee process or an enforcement 
        action referred to in the preceding sentence) shall 
        preclude, delay, or serve as the basis to stay the 
        other course of action.
    (d) Dissemination of Pediatric Information.--Not later than 
one year after the date of the enactment of the Best 
Pharmaceuticals for Children Act of 2007, the Secretary, acting 
through the Director of the National Institutes of Health, 
shall study the feasibility of establishing a compilation of 
information on pediatric drug use and report the findings to 
Congress.
    (e) Authorization of Appropriations.--
            (1) In general.--There are authorized to be 
        appropriated to carry out this section--
                    (A) $200,000,000 for fiscal year 2008; and
                    (B) such sums as are necessary for each of 
                the four succeeding fiscal years.
            (2) Availability.--Any amount appropriated under 
        paragraph (1) shall remain available to carry out this 
        section until expended.

SEC. 409J. [284Q] PAIN RESEARCH.

    (a) Research Initiatives.--
            (1) In general.--The Director of NIH is encouraged 
        to continue and expand, through the Pain Consortium, an 
        aggressive program of basic and clinical research on 
        the causes of and potential treatments for pain.
            (2) Annual recommendations.--Not less than 
        annually, the Pain Consortium, in consultation with the 
        Division of Program Coordination, Planning, and 
        Strategic Initiatives, shall develop and submit to the 
        Director of NIH recommendations on appropriate pain 
        research initiatives that could be undertaken with 
        funds reserved under section 402A(c)(1) for the Common 
        Fund or otherwise available for such initiatives.
            (3) Definition.--In this subsection, the term 
        ``Pain Consortium'' means the Pain Consortium of the 
        National Institutes of Health or a similar trans-
        National Institutes of Health coordinating entity 
        designated by the Secretary for purposes of this 
        subsection.
    (b) Interagency Pain Research Coordinating Committee.--
            (1) Establishment.--The Secretary shall establish 
        not later than 1 year after the date of the enactment 
        of this section and as necessary maintain a committee, 
        to be known as the Interagency Pain Research 
        Coordinating Committee (in this section referred to as 
        the ``Committee''), to coordinate all efforts within 
        the Department of Health and Human Services and other 
        Federal agencies that relate to pain research.
            (2) Membership.--
                    (A) In general.--The Committee shall be 
                composed of the following voting members:
                            (i) Not more than 7 voting Federal 
                        representatives appoint by the 
                        Secretary from agencies that conduct 
                        pain care research and treatment.
                            (ii) 12 additional voting members 
                        appointed under subparagraph (B).
                    (B) Additional members.--The Committee 
                shall include additional voting members 
                appointed by the Secretary as follows:
                            (i) 6 non-Federal members shall be 
                        appointed from among scientists, 
                        physicians, and other health 
                        professionals.
                            (ii) 6 members shall be appointed 
                        from members of the general public, who 
                        are representatives of leading 
                        research, advocacy, and service 
                        organizations for individuals with 
                        pain-related conditions.
                    (C) Nonvoting members.--The Committee shall 
                include such nonvoting members as the Secretary 
                determines to be appropriate.
            (3) Chairperson.--The voting members of the 
        Committee shall select a chairperson from among such 
        members. The selection of a chairperson shall be 
        subject to the approval of the Director of NIH.
            (4) Meetings.--The Committee shall meet at the call 
        of the chairperson of the Committee or upon the request 
        of the Director of NIH, but in no case less often than 
        once each year.
            (5) Duties.--The Committee shall--
                    (A) develop a summary of advances in pain 
                care research supported or conducted by the 
                Federal agencies relevant to the diagnosis, 
                prevention, and treatment of pain and diseases 
                and disorders associated with pain;
                    (B) identify critical gaps in basic and 
                clinical research on the symptoms and causes of 
                pain;
                    (C) make recommendations to ensure that the 
                activities of the National Institutes of Health 
                and other Federal agencies are free of 
                unnecessary duplication of effort;
                    (D) make recommendations on how best to 
                disseminate information on pain care; and
                    (E) make recommendations on how to expand 
                partnerships between public entities and 
                private entities to expand collaborative, 
                cross-cutting research.
            (6) Review.--The Secretary shall review the 
        necessity of the Committee at least once every 2 years.

  Part C--Specific Provisions Respecting National Research Institutes

                  Subpart 1--National Cancer Institute

                          purpose of institute
    Sec. 410. [285] The general purpose of the National Cancer 
Institute (hereafter in this subpart referred to as the 
``Institute'') is the conduct and support of research, 
training, health information dissemination, and other programs 
with respect to the cause, diagnosis, prevention, and treatment 
of cancer, rehabilitation from cancer, and the continuing care 
of cancer patients and the families of cancer patients.
                        national cancer program
    Sec. 411. [285a] The National Cancer Program shall consist 
of (1) an expanded, intensified, and coordinated cancer 
research program encompassing the research programs conducted 
and supported by the Institute and the related research 
programs of the other national research institutes, including 
an expanded and intensified research program for the prevention 
of cancer caused by occupational or environmental exposure to 
carcinogens, and (2) the other programs and activities of the 
Institute.
                        cancer control programs
    Sec. 412. [285a-1] The Director of the Institute shall 
establish and support demonstration, education, and other 
programs for the detection, diagnosis, prevention, and 
treatment of cancer and for rehabilitation and counseling 
respecting cancer. Programs established and supported under 
this section shall include--
            (1) locally initiated education and demonstration 
        programs (and regional networks of such programs) to 
        transmit research results and to disseminate 
        information respecting--
                    (A) the detection, diagnosis, prevention, 
                and treatment of cancer,
                    (B) the continuing care of cancer patients 
                and the families of cancer patients, and
                    (C) rehabilitation and counseling 
                respecting cancer,
        to physicians and other health professionals who 
        provide care to individuals who have cancer;
            (2) the demonstration of and the education of 
        students of the health professions and health 
        professionals in--
                    (A) effective methods for the prevention 
                and early detection of cancer and the 
                identification of individuals with a high risk 
                of developing cancer, and
                    (B) improved methods of patient referral to 
                appropriate centers for early diagnosis and 
                treatment of cancer; and
            (3) the demonstration of new methods for the 
        dissemination of information to the general public 
        concerning the prevention, early detection, diagnosis, 
        and treatment and control of cancer and information 
        concerning unapproved and ineffective methods, drugs, 
        and devices for the diagnosis, prevention, treatment, 
        and control of cancer.
                  special authorities of the director
    Sec. 413. [285a-2] (a)(1) The Director of the Institute 
shall establish an information and education program to 
collect, identify, analyze, and disseminate on a timely basis, 
through publications and other appropriate means, to cancer 
patients and their families, physicians and other health 
professionals, and the general public, information on cancer 
research, diagnosis, prevention, and treatment (including 
information respecting nutrition programs for cancer patients 
and the relationship between nutrition and cancer). The 
Director of the Institute may take such action as may be 
necessary to insure that all channels for the dissemination and 
exchange of scientific knowledge and information are maintained 
between the Institute and the public and between the Institute 
and other scientific, medical, and biomedical disciplines and 
organizations nationally and internationally.
    (2) In carrying out paragraph (1), the Director of the 
Institute shall--
            (A) provide public and patient information and 
        education programs, providing information that will 
        help individuals take personal steps to reduce their 
        risk of cancer, to make them aware of early detection 
        techniques and to motivate appropriate utilization of 
        those techniques, to help individuals deal with cancer 
        if it strikes, and to provide information to improve 
        long-term survival;
            (B) continue and expand programs to provide 
        physicians and the public with state-of-the-art 
        information on the treatment of particular forms of 
        cancers, and to identify those clinical trials that 
        might benefit patients while advancing knowledge of 
        cancer treatment;
            (C) assess the incorporation of state-of-the-art 
        cancer treatments into clinical practice and the extent 
        to which cancer patients receive such treatments and 
        include the results of such assessments in the biennial 
        reports required under section 407;
            (D) maintain and operate the International Cancer 
        Research Data Bank, which shall collect, catalog, 
        store, and disseminate insofar as feasible the results 
        of cancer research and treatment undertaken in any 
        country for the use of any person involved in cancer 
        research and treatment in any country; and
            (E) to the extent practicable, in disseminating the 
        results of such cancer research and treatment, utilize 
        information systems available to the public.
    (b) The Director of the Institute in carrying out the 
National Cancer Program--
            (1) shall establish or support the large-scale 
        production or distribution of specialized biological 
        materials and other therapeutic substances for cancer 
        research and set standards of safety and care for 
        persons using such materials;
            (2) shall, in consultation with the advisory 
        council for the Institute, support (A) research in the 
        cancer field outside the United States by highly 
        qualified foreign nationals which can be expected to 
        benefit the American people, (B) collaborative research 
        involving American and foreign participants, and (C) 
        the training of American scientists abroad and foreign 
        scientists in the United States;
            (3) shall, in consultation with the advisory 
        council for the Institute, support appropriate programs 
        of education and training (including continuing 
        education and laboratory and clinical research 
        training);
            (4) shall encourage and coordinate cancer research 
        by industrial concerns where such concerns evidence a 
        particular capability for such research;
            (5) may obtain (after consultation with the 
        advisory council for the Institute and in accordance 
        with section 3109 of title 5, United States Code, but 
        without regard to the limitation in such section on the 
        period of service) the services of not more than one 
        hundred and fifty-one experts or consultants who have 
        scientific or professional qualifications;
            (6)(A) may, in consultation with the advisory 
        council for the Institute, acquire, construct, improve, 
        repair, operate, and maintain laboratories, other 
        research facilities, equipment, and such other real or 
        personal property as the Director determines necessary;
            (B) may, in consultation with the advisory council 
        for the Institute, make grants for construction or 
        renovation of facilities; and
            (C) may, in consultation with the advisory council 
        for the Institute, acquire, without regard to the Act 
        of March 3, 1877 (40 U.S.C. 34), by lease or otherwise 
        through the Administrator of General Services, 
        buildings or parts of buildings in the District of 
        Columbia or communities located adjacent to the 
        District of Columbia for the use of the Institute for a 
        period not to exceed ten years;
            (7) may, in consultation with the advisory council 
        for the Institute, appoint one or more advisory 
        committees composed of such private citizens and 
        officials of Federal, State, and local governments to 
        advise the Director with respect to the Director's 
        functions;
            (8) may, subject to section 405(b)(2) and without 
        regard to section 3324 of title 31, United States Code, 
        and section 3709 of the Revised Statutes (41 U.S.C. 5), 
        enter into such contracts, leases, cooperative 
        agreements, as may be necessary in the conduct of 
        functions of the Director, with any public agency, or 
        with any person, firm, association, corporation, or 
        educational institution; and
            (9) shall, notwithstanding section 405(a), prepare 
        and submit, directly to the President for review and 
        transmittal to Congress, an annual budget estimate 
        (including an estimate of the number and type of 
        personnel needs for the Institute) for the National 
        Cancer Program, after reasonable opportunity for 
        comment (but without change) by the Secretary, the 
        Director of NIH, and the Institute's advisory council.
Except as otherwise provided, experts and consultants whose 
services are obtained under paragraph (5) shall be paid or 
reimbursed, in accordance with title 5, United States Code, for 
their travel to and from their place of service and for other 
expenses associated with their assignment. Such expenses shall 
not be allowed in connection with the assignment of an expert 
or consultant whose services are obtained under paragraph (5) 
unless the expert or consultant has agreed in writing to 
complete the entire period of the assignment or one year of the 
assignment, whichever is shorter, unless separated or 
reassigned for reasons which are beyond the control of the 
expert or consultant and which are acceptable to the Director 
of the Institute. If the expert or consultant violates the 
agreement, the money spent by the United States for such 
expenses is recoverable from the expert or consultant as a debt 
due the United States. The Secretary may waive in whole or in 
part a right of recovery under the preceding sentence.
    (c) Pre-Clinical Models To Evaluate Promising Pediatric 
Cancer Therapies.--
            (1) Expansion and coordination of activities.--The 
        Director of the National Cancer Institute shall expand, 
        intensify, and coordinate the activities of the 
        Institute with respect to research on the development 
        of preclinical models to evaluate which therapies are 
        likely to be effective for treating pediatric cancer.
            (2) Coordination with other institutes.--The 
        Director of the Institute shall coordinate the 
        activities under paragraph (1) with similar activities 
        conducted by other national research institutes and 
        agencies of the National Institutes of Health to the 
        extent that those Institutes and agencies have 
        responsibilities that are related to pediatric cancer.
           national cancer research and demonstration centers
    Sec. 414. [285a-3] (a)(1) The Director of the Institute may 
enter into cooperative agreements with and make grants to 
public or private nonprofit entities to pay all or part of the 
cost of planning, establishing, or strengthening, and providing 
basic operating support for centers for basic and clinical 
research into, training in, and demonstration of advanced 
diagnostic, prevention, control, and treatment methods for 
cancer.
    (2) A cooperative agreement or grant under paragraph (1) 
shall be entered into in accordance with policies established 
by the Director of NIH and after consultation with the 
Institute's advisory council.
    (b) Federal payments made under a cooperative agreement or 
grant under subsection (a) may be used for--
            (1) construction (notwithstanding any limitation 
        under section 496);
            (2) staffing and other basic operating costs, 
        including such patient care costs as are required for 
        research;
            (3) clinical training, including training for 
        allied health professionals, continuing education for 
        health professionals and allied health professions 
        personnel, and information programs for the public 
        respecting cancer; and
            (4) demonstration purposes.
As used in this paragraph, the term ``construction'' does not 
include the acquisition of land, and the term ``training'' does 
not include research training for which National Research 
Service Awards \1\ may be provided under section 487.
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    \1\ Now Ruth L. Kirschstein National Research Service Awards. See 
section 487.
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    (c) Support of a center under subsection (a) may be for a 
period of not to exceed five years. Such period may be extended 
by the Director for additional periods of not more than five 
years each if the operations of such center have been reviewed 
by an appropriate technical and scientific peer review group 
established by the Director and if such group has recommended 
to the Director that such period should be extended.
    (d) Research centers under this section may not be 
considered centers of excellence for purposes of section 
402(b)(10).
                        president's cancer panel
    Sec. 415. [285a-4] (a)(1) The President's Cancer Panel 
(hereafter in this section referred to as the ``Panel'') shall 
be composed of three persons appointed by the President who by 
virtue of their training, experience, and background are 
exceptionally qualified to appraise the National Cancer 
Program. At least two members of the Panel shall be 
distinguished scientists or physicians.
    (2)(A) Members of the Panel shall be appointed for three-
year terms, except that (i) any member appointed to fill a 
vacancy occurring prior to the expiration of the term for which 
the member's predecessor was appointed shall be appointed only 
for the remainder of such term, and (ii) a member may serve 
until the member's successor has taken office. If a vacancy 
occurs in the Panel, the President shall make an appointment to 
fill the vacancy not later than 90 days after the date the 
vacancy occurred.
    (B) The President shall designate one of the members to 
serve as the chairman of the Panel for a term of one year.
    (C) Members of the Panel shall each be entitled to receive 
the daily equivalent of the annual rate of basic pay in effect 
for grade GS-18 of the General Schedule for each day (including 
traveltime) during which they are engaged in the actual 
performance of duties as members of the Panel and shall be paid 
or reimbursed, in accordance with title 5, United States Code, 
for their travel to and from their place of service and for 
other expenses associated with their assignment.
    (3) The Panel shall meet at the call of the chairman, but 
not less often than four times a year. A transcript shall be 
kept of the proceedings of each meeting of the Panel, and the 
chairman shall make such transcript available to the public.
    (b) The Panel shall monitor the development and execution 
of the activities of the National Cancer Program, and shall 
report directly to the President. Any delays or blockages in 
rapid execution of the Program shall immediately be brought to 
the attention of the President. The Panel shall submit to the 
President periodic progress reports on the National Cancer 
Program and shall submit to the President, the Secretary, and 
the Congress an annual evaluation of the efficacy of the 
Program and suggestions for improvements, and shall submit such 
other reports as the President shall direct.
                   associate director for prevention
    Sec. 416. [285a-5] (a) There shall be in the Institute an 
Associate Director for Prevention to coordinate and promote the 
programs in the Institute concerning the prevention of cancer. 
The Associate Director shall be appointed by the Director of 
the Institute from individuals who because of their 
professional training or experience are experts in public 
health or preventive medicine.
    (b) The Associate Director for Prevention shall prepare for 
inclusion in the biennial report made under section 407 a 
description of the prevention activities of the Institute, 
including a description of the staff and resources allocated to 
those activities.
                    breast and gynecological cancers
    Sec. 417. [285a-6] (a) Expansion and Coordination of 
Activities.--The Director of the Institute, in consultation 
with the National Cancer Advisory Board, shall expand, 
intensify, and coordinate the activities of the Institute with 
respect to research on breast cancer, ovarian cancer, and other 
cancers of the reproductive system of women.
    (b) Coordination With Other Institutes.--The Director of 
the Institute shall coordinate the activities of the Director 
under subsection (a) with similar activities conducted by other 
national research institutes and agencies of the National 
Institutes of Health to the extent that such Institutes and 
agencies have responsibilities that are related to breast 
cancer and other cancers of the reproductive system of women.
    (c) Programs for Breast Cancer.--
            (1) In general.--In carrying out subsection (a), 
        the Director of the Institute shall conduct or support 
        research to expand the understanding of the cause of, 
        and to find a cure for, breast cancer. Activities under 
        such subsection shall provide for an expansion and 
        intensification of the conduct and support of--
                    (A) basic research concerning the etiology 
                and causes of breast cancer;
                    (B) clinical research and related 
                activities concerning the causes, prevention, 
                detection and treatment of breast cancer;
                    (C) control programs with respect to breast 
                cancer in accordance with section 412, 
                including community-based programs designed to 
                assist women who are members of medically 
                underserved populations, low-income 
                populations, or minority groups;
                    (D) information and education programs with 
                respect to breast cancer in accordance with 
                section 413; and
                    (E) research and demonstration centers with 
                respect to breast cancer in accordance with 
                section 414, including the development and 
                operation of centers for breast cancer research 
                to bring together basic and clinical, 
                biomedical and behavioral scientists to conduct 
                basic, clinical, epidemiological, psychosocial, 
                prevention and treatment research and related 
                activities on breast cancer.
        Not less than six centers shall be operated under 
        subparagraph (E). Activities of such centers should 
        include supporting new and innovative research and 
        training programs for new researchers. Such centers 
        shall give priority to expediting the transfer of 
        research advances to clinical applications.
            (2) Implementation of plan for programs.--
                    (A) The Director of the Institute shall 
                ensure that the research programs described in 
                paragraph (1) are implemented in accordance 
                with a plan for the programs. Such plan shall 
                include comments and recommendations that the 
                Director of the Institute considers 
                appropriate, with due consideration provided to 
                the professional judgment needs of the 
                Institute as expressed in the annual budget 
                estimate prepared in accordance with section 
                413(9) \1\. The Director of the Institute, in 
                consultation with the National Cancer Advisory 
                Board, shall periodically review and revise 
                such plan.
---------------------------------------------------------------------------
    \1\ So in law. See section 401 of Public Law 103-43 (107 Stat. 
153). Probably should be section ``413(b)(9)''.
---------------------------------------------------------------------------
                    (B) Not later than October 1, 1993, the 
                Director of the Institute shall submit a copy 
                of the plan to the President's Cancer Panel, 
                the Secretary and the Director of NIH.
                    (C) The Director of the Institute shall 
                submit any revisions of the plan to the 
                President's Cancer Panel, the Secretary, and 
                the Director of NIH.
                    (D) The Secretary shall provide a copy of 
                the plan submitted under subparagraph (A), and 
                any revisions submitted under subparagraph (C), 
                to the Committee on Energy and Commerce of the 
                House of Representatives and the Committee on 
                Labor and Human Resources of the Senate.
    (d) Other Cancers.--In carrying out subsection (a), the 
Director of the Institute shall conduct or support research on 
ovarian cancer and other cancers of the reproductive system of 
women. Activities under such subsection shall provide for the 
conduct and support of--
            (1) basic research concerning the etiology and 
        causes of ovarian cancer and other cancers of the 
        reproductive system of women;
            (2) clinical research and related activities into 
        the causes, prevention, detection and treatment of 
        ovarian cancer and other cancers of the reproductive 
        system of women;
            (3) control programs with respect to ovarian cancer 
        and other cancers of the reproductive system of women 
        in accordance with section 412;
            (4) information and education programs with respect 
        to ovarian cancer and other cancers of the reproductive 
        system of women in accordance with section 413; and
            (5) research and demonstration centers with respect 
        to ovarian cancer and cancers of the reproductive 
        system in accordance with section 414.
    (e) Report.--The Director of the Institute shall prepare, 
for inclusion in the biennial report submitted under section 
407, a report that describes the activities of the National 
Cancer Institute under the research programs referred to in 
subsection (a), that shall include--
            (1) a description of the research plan with respect 
        to breast cancer prepared under subsection (c);
            (2) an assessment of the development, revision, and 
        implementation of such plan;
            (3) a description and evaluation of the progress 
        made, during the period for which such report is 
        prepared, in the research programs on breast cancer and 
        cancers of the reproductive system of women;
            (4) a summary and analysis of expenditures made, 
        during the period for which such report is made, for 
        activities with respect to breast cancer and cancers of 
        the reproductive system of women conducted and 
        supported by the National Institutes of Health; and
            (5) such comments and recommendations as the 
        Director considers appropriate.
                            prostate cancer
    Sec. 417A. [285a-7] (a) Expansion and Coordination of 
Activities.--The Director of the Institute, in consultation 
with the National Cancer Advisory Board, shall expand, 
intensify, and coordinate the activities of the Institute with 
respect to research on prostate cancer.
    (b) Coordination With Other Institutes.--The Director of 
the Institute shall coordinate the activities of the Director 
under subsection (a) with similar activities conducted by other 
national research institutes and agencies of the National 
Institutes of Health to the extent that such Institutes and 
agencies have responsibilities that are related to prostate 
cancer.
    (c) Programs.--
            (1) In general.--In carrying out subsection (a), 
        the Director of the Institute shall conduct or support 
        research to expand the understanding of the cause of, 
        and to find a cure for, prostate cancer. Activities 
        under such subsection shall provide for an expansion 
        and intensification of the conduct and support of--
                    (A) basic research concerning the etiology 
                and causes of prostate cancer;
                    (B) clinical research and related 
                activities concerning the causes, prevention, 
                detection and treatment of prostate cancer;
                    (C) prevention and control and early 
                detection programs with respect to prostate 
                cancer in accordance with section 412, 
                particularly as it relates to intensifying 
                research on the role of prostate specific 
                antigen for the screening and early detection 
                of prostate cancer;
                    (D) an Inter-Institute Task Force, under 
                the direction of the Director of the Institute, 
                to provide coordination between relevant 
                National Institutes of Health components of 
                research efforts on prostate cancer;
                    (E) control programs with respect to 
                prostate cancer in accordance with section 412;
                    (F) information and education programs with 
                respect to prostate cancer in accordance with 
                section 413; and
                    (G) research and demonstration centers with 
                respect to prostate cancer in accordance with 
                section 414, including the development and 
                operation of centers for prostate cancer 
                research to bring together basic and clinical, 
                biomedical and behavioral scientists to conduct 
                basic, clinical, epidemiological, psychosocial, 
                prevention and control, treatment, research, 
                and related activities on prostate cancer.
        Not less than six centers shall be operated under 
        subparagraph (G). Activities of such centers should 
        include supporting new and innovative research and 
        training programs for new researchers. Such centers 
        shall give priority to expediting the transfer of 
        research advances to clinical applications.
            (2) Implementation of plan for programs.--
                    (A) The Director of the Institute shall 
                ensure that the research programs described in 
                paragraph (1) are implemented in accordance 
                with a plan for the programs. Such plan shall 
                include comments and recommendations that the 
                Director of the Institute considers 
                appropriate, with due consideration provided to 
                the professional judgment needs of the 
                Institute as expressed in the annual budget 
                estimate prepared in accordance with section 
                413(9) \1\. The Director of the Institute, in 
                consultation with the National Cancer Advisory 
                Board, shall periodically review and revise 
                such plan.
---------------------------------------------------------------------------
    \1\ So in law. See section 402 of Public Law 103-43 (107 Stat. 
155). Probably should be ``section 413(b)(9)''.
---------------------------------------------------------------------------
                    (B) Not later than October 1, 1993, the 
                Director of the Institute shall submit a copy 
                of the plan to the President's Cancer Panel, 
                the Secretary, and the Director of NIH.
                    (C) The Director of the Institute shall 
                submit any revisions of the plan to the 
                President's Cancer Panel, the Secretary, and 
                the Director of NIH.
                    (D) The Secretary shall provide a copy of 
                the plan submitted under subparagraph (A), and 
                any revisions submitted under subparagraph (C), 
                to the Committee on Energy and Commerce of the 
                House of Representatives and the Committee on 
                Labor and Human Resources of the Senate. \1\
---------------------------------------------------------------------------
    \1\ Section 417B was repealed by section 103(b)(15) of Public Law 
109-482 (120 Stat. 3687).
---------------------------------------------------------------------------

SEC. 417C. [285A-9] GRANTS FOR EDUCATION, PREVENTION, AND EARLY 
                    DETECTION OF RADIOGENIC CANCERS AND DISEASES.

    (a) Definition.--In this section the term ``entity'' means 
any--
            (1) National Cancer Institute-designated cancer 
        center;
            (2) Department of Veterans Affairs hospital or 
        medical center;
            (3) Federally Qualified Health Center, community 
        health center, or hospital;
            (4) agency of any State or local government, 
        including any State department of health; or
            (5) nonprofit organization.
    (b) In General.--The Secretary, acting through the 
Administrator of the Health Resources and Services 
Administration in consultation with the Director of the 
National Institutes of Health and the Director of the Indian 
Health Service, may make competitive grants to any entity for 
the purpose of carrying out programs to--
            (1) screen individuals described under section 
        4(a)(1)(A)(i) or 5(a)(1)(A) of the Radiation Exposure 
        Compensation Act (42 U.S.C. 2210 note) for cancer as a 
        preventative health measure;
            (2) provide appropriate referrals for medical 
        treatment of individuals screened under paragraph (1) 
        and to ensure, to the extent practicable, the provision 
        of appropriate follow-up services;
            (3) develop and disseminate public information and 
        education programs for the detection, prevention, and 
        treatment of radiogenic cancers and diseases; and
            (4) facilitate putative applicants in the 
        documentation of claims as described in section 5(a) of 
        the Radiation Exposure Compensation Act (42 U.S.C. 2210 
        note).
    (c) Indian Health Service.--The programs under subsection 
(a) shall include programs provided through the Indian Health 
Service or through tribal contracts, compacts, grants, or 
cooperative agreements with the Indian Health Service and which 
are determined appropriate to raising the health status of 
Indians.
    (d) Grant and Contract Authority.--Entities receiving a 
grant under subsection (b) may expend the grant to carry out 
the purpose described in such subsection.
    (e) Health Coverage Unaffected.--Nothing in this section 
shall be construed to affect any coverage obligation of a 
governmental or private health plan or program relating to an 
individual referred to under subsection (b)(1).
======================================================================


SEC. 417D. [285A-10] RESEARCH, INFORMATION, AND EDUCATION WITH RESPECT 
                    TO BLOOD CANCER. \1\
---------------------------------------------------------------------------

    \1\ Section 417D (as amended by Public Law 109-482) is shown after 
section 417C for the convenience of the reader. Section 3 of Public Law 
107-172 (116 Stat. 541) attempts to amend this part by inserting a new 
section 417D ``after section 419C''. The amendment cannot be executed, 
as this part does not contain a section 419C.
---------------------------------------------------------------------------
    (a) Joe Moakley Research Excellence Program.--
            (1) In general.--The Director of NIH shall expand, 
        intensify, and coordinate programs for the conduct and 
        support of research with respect to blood cancer, and 
        particularly with respect to leukemia, lymphoma, and 
        multiple myeloma.
            (2) Administration.--The Director of NIH shall 
        carry out this subsection through the Director of the 
        National Cancer Institute and in collaboration with any 
        other agencies that the Director determines to be 
        appropriate.
    (b) Geraldine Ferraro Cancer Education Program.--
            (1) In general.--The Secretary shall direct the 
        appropriate agency within the Department of Health and 
        Human Services, in collaboration with the Director of 
        NIH, to establish and carry out a program to provide 
        information and education for patients and the general 
        public with respect to blood cancer, and particularly 
        with respect to the treatment of leukemia, lymphoma, 
        and multiple myeloma.
            (2) Administration.--The Agency determined by the 
        Secretary under paragraph (1) shall carry out this 
        subsection in collaboration with private health 
        organizations that have national education and patient 
        assistance programs on blood-related cancers.
=======================================================================


SEC. 417E. [285A-11] PEDIATRIC CANCER RESEARCH AND AWARENESS.

    (a) Pediatric Cancer Research.--
            (1) Programs of research excellence in pediatric 
        cancer.--The Secretary, in collaboration with the 
        Director of NIH and other Federal agencies with 
        interest in prevention and treatment of pediatric 
        cancer, shall continue to enhance, expand, and 
        intensify pediatric cancer research and other 
        activities related to pediatric cancer, including 
        therapeutically applicable research to generate 
        effective treatments, pediatric preclinical testing, 
        and pediatric clinical trials through National Cancer 
        Institute-supported pediatric cancer clinical trial 
        groups and their member institutions. In enhancing, 
        expanding, and intensifying such research and other 
        activities, the Secretary is encouraged to take into 
        consideration the application of such research and 
        other activities for minority, health disparity, and 
        medically underserved communities. For purposes of this 
        section, the term ``pediatric cancer research'' means 
        research on the causes, prevention, diagnosis, 
        recognition, treatment, and long-term effects of 
        pediatric cancer.
            (2) Peer review requirements.--All grants awarded 
        under this subsection shall be awarded in accordance 
        with section 492.
    (b) Public Awareness of Pediatric Cancers and Available 
Treatments and Research.--
            (1) In general.--The Secretary may award grants to 
        childhood cancer professional and direct service 
        organizations for the expansion and widespread 
        implementation of--
                    (A) activities that provide available 
                information on treatment protocols to ensure 
                early access to the best available therapies 
                and clinical trials for pediatric cancers;
                    (B) activities that provide available 
                information on the late effects of pediatric 
                cancer treatment to ensure access to necessary 
                long-term medical and psychological care; and
                    (C) direct resource services such as 
                educational outreach for parents, peer-to-peer 
                and parent-to-parent support networks, 
                information on school re-entry and 
                postsecondary education, and resource 
                directories or referral services for financial 
                assistance, psychological counseling, and other 
                support services.
        In awarding grants under this paragraph, the Secretary 
        is encouraged to take into consideration the extent to 
        which an entity would use such grant for purposes of 
        making activities and services described in this 
        paragraph available to minority, health disparity, and 
        medically underserved communities.
            (2) Performance measurement, transparency, and 
        accountability.--For each grant awarded under this 
        subsection, the Secretary shall develop and implement 
        metrics-based performance measures to assess the 
        effectiveness of activities funded under such grant.
            (3) Informational requirements.--Any information 
        made available pursuant to a grant awarded under 
        paragraph (1) shall be--
                    (A) culturally and linguistically 
                appropriate as needed by patients and families 
                affected by childhood cancer; and
                    (B) approved by the Secretary.
    (c) Rule of Construction.--Nothing in this section shall be 
construed as being inconsistent with the goals and purposes of 
the Minority Health and Health Disparities Research and 
Education Act of 2000 (42 U.S.C. 202 note) \1\.
---------------------------------------------------------------------------
    \1\ The patenthetical reference to 42 U.S.C. 202 note in subsection 
(c) probably should be stricken or revised to refer to 42 U.S.C. 201 
note.
---------------------------------------------------------------------------
    (d) Authorization of Appropriations.--For purposes of 
carrying out this section and section 399E-1, there are 
authorized to be appropriated $30,000,000 for each of fiscal 
years 2009 through 2013. Such authorization of appropriations 
is in addition to the authorization of appropriations 
established in section 402A with respect to such purpose. Funds 
appropriated under this subsection shall remain available until 
expended.

SEC. 417F. [42 U.S.C. 285A-12] INTERAGENCY BREAST CANCER AND 
                    ENVIRONMENTAL RESEARCH COORDINATING COMMITTEE.

    (a) Interagency Breast Cancer and Environmental Research 
Coordinating Committee.--
            (1) Establishment.--Not later than 6 months after 
        the date of the enactment of this section, the 
        Secretary shall establish a committee, to be known as 
        the Interagency Breast Cancer and Environmental 
        Research Coordinating Committee (in this section 
        referred to as the ``Committee'').
            (2) Duties.--The Committee shall--
                    (A) share and coordinate information on 
                existing research activities, and make 
                recommendations to the National Institutes of 
                Health and other Federal agencies regarding how 
                to improve existing research programs, that are 
                related to breast cancer research;
                    (B) develop a comprehensive strategy and 
                advise the National Institutes of Health and 
                other Federal agencies in the solicitation of 
                proposals for collaborative, multidisciplinary 
                research, including proposals to evaluate 
                environmental and genomic factors that may be 
                related to the etiology of breast cancer that 
                would--
                            (i) result in innovative approaches 
                        to study emerging scientific 
                        opportunities or eliminate knowledge 
                        gaps in research to improve the 
                        research portfolio;
                            (ii) outline key research 
                        questions, methodologies, and knowledge 
                        gaps;
                            (iii) expand the number of research 
                        proposals that involve collaboration 
                        between 2 or more national research 
                        institutes or national centers, 
                        including proposals for Common Fund 
                        research described in section 402(b)(7) 
                        to improve the research portfolio; and
                            (iv) expand the number of 
                        collaborative, multidisciplinary, and 
                        multi-institutional research grants;
                    (C) develop a summary of advances in breast 
                cancer research supported or conducted by 
                Federal agencies relevant to the diagnosis, 
                prevention, and treatment of cancer and other 
                diseases and disorders; and
                    (D) not later than 2 years after the date 
                of the establishment of the Committee, make 
                recommendations to the Secretary--
                            (i) regarding any appropriate 
                        changes to research activities, 
                        including recommendations to improve 
                        the research portfolio of the National 
                        Institutes of Health to ensure that 
                        scientifically-based strategic planning 
                        is implemented in support of research 
                        priorities that impact breast cancer 
                        research activities;
                            (ii) to ensure that the activities 
                        of the National Institutes of Health 
                        and other Federal agencies, including 
                        the Department of Defense, are free of 
                        unnecessary duplication of effort;
                            (iii) regarding public 
                        participation in decisions relating to 
                        breast cancer research to increase the 
                        involvement of patient advocacy and 
                        community organizations representing a 
                        broad geographical area;
                            (iv) on how best to disseminate 
                        information on breast cancer research 
                        progress; and
                            (v) on how to expand partnerships 
                        between public entities, including 
                        Federal agencies, and private entities 
                        to expand collaborative, cross-cutting 
                        research.
            (3) Rule of construction.--For the purposes of the 
        Committee, when focusing on research to evaluate 
        environmental and genomic factors that may be related 
        to the etiology of breast cancer, nothing in this 
        section shall be construed to restrict the Secretary 
        from including other forms of cancer, as appropriate, 
        when doing so may advance research in breast cancer or 
        advance research in other forms of cancer.
            (4) Membership.--
                    (A) In general.--The Committee shall be 
                composed of the following voting members:
                            (i) Not more than 7 voting Federal 
                        representatives as follows:
                                    (I) The Director of the 
                                Centers for Disease Control and 
                                Prevention.
                                    (II) The Director of the 
                                National Institutes of Health 
                                and the directors of such 
                                national research institutes 
                                and national centers (which may 
                                include the National Institute 
                                of Environmental Health 
                                Sciences) as the Secretary 
                                determines appropriate.
                                    (III) One representative 
                                from the National Cancer 
                                Institute Board of Scientific 
                                Advisors, appointed by the 
                                Director of the National Cancer 
                                Institute.
                                    (IV) The heads of such 
                                other agencies of the 
                                Department of Health and Human 
                                Services as the Secretary 
                                determines appropriate.
                                    (V) Representatives of 
                                other Federal agencies that 
                                conduct or support cancer 
                                research, including the 
                                Department of Defense.
                            (ii) 12 additional voting members 
                        appointed under subparagraph (B).
                    (B) Additional members.--The Committee 
                shall include additional voting members 
                appointed by the Secretary as follows:
                            (i) 6 members shall be appointed 
                        from among scientists, physicians, and 
                        other health professionals, who--
                                    (I) are not officers or 
                                employees of the United States;
                                    (II) represent multiple 
                                disciplines, including 
                                clinical, basic, and public 
                                health sciences;
                                    (III) represent different 
                                geographical regions of the 
                                United States;
                                    (IV) are from practice 
                                settings, academia, or other 
                                research settings; and
                                    (V) are experienced in 
                                scientific peer review process.
                            (ii) 6 members shall be appointed 
                        from members of the general public, who 
                        represent individuals with breast 
                        cancer.
                    (C) Nonvoting members.--The Committee shall 
                include such nonvoting members as the Secretary 
                determines to be appropriate.
            (5) Chairperson.--The voting members of the 
        Committee shall select a chairperson from among such 
        members. The selection of a chairperson shall be 
        subject to the approval of the Director of NIH.
            (6) Meetings.--The Committee shall meet at the call 
        of the chairperson of the Committee or upon the request 
        of the Director of NIH, but in no case less often than 
        once each year.
    (b) Review.--The Secretary shall review the necessity of 
the Committee in calendar year 2011 and, thereafter, at least 
once every 2 years.

          Subpart 2--National Heart, Lung, and Blood Institute

                        PURPOSE OF THE INSTITUTE

    Sec. 418. [285b] The general purpose of the National Heart, 
Lung, and Blood Institute (hereafter in this subpart referred 
to as the ``Institute'') is the conduct and support of 
research, training, health information dissemination, and other 
programs with respect to heart, blood vessel, lung, and blood 
diseases and with respect to the use of blood and blood 
products and the management of blood resources.

  HEART, BLOOD VESSEL, LUNG, AND BLOOD DISEASE PREVENTION AND CONTROL 
                                PROGRAMS

    Sec. 419. [285b-1] (a) The Director of the Institute shall 
conduct and support programs for the prevention and control of 
heart, blood vessel, lung, and blood diseases. Such programs 
shall include community-based and population-based programs 
carried out in cooperation with other Federal agencies, with 
public health agencies of State or local governments, with 
nonprofit private entities that are community-based health 
agencies, or with other appropriate public or nonprofit private 
entities.
    (b) In carrying out programs under subsection (a), the 
Director of the Institute shall give special consideration to 
the prevention and control of heart, blood vessel, lung, and 
blood diseases in children, and in populations that are at 
increased risk with respect to such diseases.

                       INFORMATION AND EDUCATION

    Sec. 420. [285b-2] The Director of the Institute shall 
collect, identify, analyze, and disseminate on a timely basis, 
through publications and other appropriate means, to patients, 
families of patients, physicians and other health 
professionals, and the general public, information on research, 
prevention, diagnosis, and treatment of heart, blood vessel, 
lung, and blood diseases, the maintenance of health to reduce 
the incidence of such diseases, and on the use of blood and 
blood products and the management of blood resources. In 
carrying out this section, the Director of the Institute shall 
place special emphasis upon the utilization of collaborative 
efforts with both the public and private sectors to--
            (1) increase the awareness and knowledge of health 
        care professionals and the public regarding the 
        prevention of heart and blood vessel, lung, and blood 
        diseases and the utilization of blood resources; and
            (2) develop and disseminate to health 
        professionals, patients and patient families, and the 
        public information designed to encourage adults and 
        children to adopt healthful practices concerning the 
        prevention of such diseases.

   NATIONAL HEART, BLOOD VESSEL, LUNG, AND BLOOD DISEASES AND BLOOD 
                           RESOURCES PROGRAM

    Sec. 421. [285b-3] (a)(1) The National Heart, Blood Vessel, 
Lung, and Blood Diseases and Blood Resources Program (hereafter 
in this subpart referred to as the ``Program'' may provide 
for--
            (A) investigation into the epidemiology, etiology, 
        and prevention of all forms and aspects of heart, blood 
        vessel, lung, and blood diseases, including 
        investigations into the social, environmental, 
        behavioral, nutritional, biological, and genetic 
        determinants and influences involved in the 
        epidemiology, etiology, and prevention of such 
        diseases;
            (B) studies and research into the basic biological 
        processes and mechanisms involved in the underlying 
        normal and abnormal heart, blood vessel, lung, and 
        blood phenomena;
            (C) research into the development, trial, and 
        evaluation of techniques, drugs, and devices (including 
        computers) used in, and approaches to, the diagnosis, 
        treatment (including the provision of emergency medical 
        services), and prevention of heart, blood vessel, lung, 
        and blood diseases and the rehabilitation of patients 
        suffering from such diseases;
            (D) establishment of programs that will focus and 
        apply scientific and technological efforts involving 
        the biological, physical, and engineering sciences to 
        all facets of heart, blood vessel, lung, and blood 
        diseases with emphasis on the refinement, development, 
        and evaluation of technological devices that will 
        assist, replace, or monitor vital organs and improve 
        instrumentation for detection, diagnosis, and treatment 
        of and rehabilitation from such diseases;
            (E) establishment of programs for the conduct and 
        direction of field studies, large-scale testing and 
        evaluation, and demonstration of preventive, 
        diagnostic, therapeutic, and rehabilitative approaches 
        to, and emergency medical services for, such diseases;
            (F) studies and research into blood diseases and 
        blood, and into the use of blood for clinical purposes 
        and all aspects of the management of blood resources in 
        the United States, including the collection, 
        preservation, fractionation, and distribution of blood 
        and blood products;
            (G) the education (including continuing education) 
        and training of scientists, clinical investigators, and 
        educators, in fields and specialties (including 
        computer sciences) requisite to the conduct of clinical 
        programs respecting heart, blood vessel, lung, and 
        blood diseases and blood resources;
            (H) public and professional education relating to 
        all aspects of such diseases, including the prevention 
        of such diseases, and the use of blood and blood 
        products and the management of blood resources;
            (I) establishment of programs for study and 
        research into heart, blood vessel, lung, and blood 
        diseases of children (including cystic fibrosis, 
        hyaline membrane, hemolytic diseases such as sickle 
        cell anemia and Cooley's anemia, and hemophilic 
        diseases) and for the development and demonstration of 
        diagnostic, treatment, and preventive approaches to 
        such diseases; and
            (J) establishment of programs for study, research, 
        development, demonstrations and evaluation of emergency 
        medical services for people who become critically ill 
        in connection with heart, blood vessel, lung, or blood 
        diseases.
    (2) The Program shall be coordinated with other national 
research institutes to the extent that they have 
responsibilities respecting such diseases and shall give 
special emphasis to the continued development in the Institute 
of programs related to the causes of stroke and to effective 
coordination of such programs with related stroke programs in 
the National Institute of Neurological and Communicative 
Disorders and Stroke. The Director of the Institute, with the 
advice of the advisory council for the Institute, shall revise 
annually the plan for the Program and shall carry out the 
Program in accordance with such plan.
    (b) In carrying out the Program, the Director of the 
Institute, under policies established by the Director of NIH--
            (1) may, after consultation with the advisory 
        council for the Institute, obtain (in accordance with 
        section 3109 of title 5, United States Code, but 
        without regard to the limitation in such section on the 
        period of such service) the services of not more than 
        one hundred experts or consultants who have scientific 
        or professional qualifications;
            (2)(A) may, in consultation with the advisory 
        council for the Institute, acquire and construct, 
        improve, repair, operate, alter, renovate, and 
        maintain, heart, blood vessel, lung, and blood disease 
        and blood resource laboratories, research, training, 
        and other facilities, equipment, and such other real or 
        personal property as the Director determines necessary;
            (B) may, in consultation with the advisory council 
        for the Institute, make grants for construction or 
        renovation of facilities; and
            (C) may, in consultation with the advisory council 
        for the Institute, acquire, without regard to the Act 
        of March 3, 1877 (40 U.S.C. 34), by lease or otherwise, 
        through the Administrator of General Services, 
        buildings or parts of buildings in the District of 
        Columbia or communities located adjacent to the 
        District of Columbia for the use of the Institute for a 
        period not to exceed ten years;
            (3) subject to section 405(b)(2) and without regard 
        to section 3324 of title 31, United States Code, and 
        section 3709 of the Revised Statutes (41 U.S.C. 5), may 
        enter into such contracts, leases, cooperative 
        agreements, or other transactions, as may be necessary 
        in the conduct of the Director's functions, with any 
        public agency, or with any person, firm, association, 
        corporation, or educational institutions;
            (4) may make grants to public and nonprofit private 
        entities to assist in meeting the cost of the care of 
        patients in hospitals, clinics, and related facilities 
        who are participating in research projects; and
            (5) shall, in consultation with the advisory 
        council for the Institute, conduct appropriate 
        intramural training and education programs, including 
        continuing education and laboratory and clinical 
        research training programs.
Except as otherwise provided, experts and consultants whose 
services are obtained under paragraph (1) shall be paid or 
reimbursed, in accordance with title 5, United States Code, for 
their travel to and from their place of service and for other 
expenses associated with their assignment. Such expenses shall 
not be allowed in connection with the assignment of an expert 
or consultant whose services are obtained under paragraph (1) 
unless the expert or consultant has agreed in writing to 
complete the entire period of the assignment or one year of the 
assignment, whichever is shorter, unless separated or 
reassigned for reasons which are beyond the control of the 
expert or consultant and which are acceptable to the Director 
of the Institute. If the expert or consultant violates the 
agreement, the money spent by the United States for such 
expenses is recoverable from the expert or consultant as a debt 
due the United States. The Secretary may waive in whole or in 
part a right of recovery under the preceding sentence.

 NATIONAL RESEARCH AND DEMONSTRATION CENTERS FOR HEART, BLOOD VESSEL, 
   LUNG, AND BLOOD DISEASES, SICKLE CELL ANEMIA, AND BLOOD RESOURCES

    Sec. 422. [285b-4] (a)(1) The Director of the Institute may 
provide, in accordance with subsection (c), for the development 
of--
            (A) ten centers for basic and clinical research 
        into, training in, and demonstration of, advanced 
        diagnostic, prevention, and treatment and 
        rehabilitation methods (including methods of providing 
        emergency medical services) for heart and blood vessel 
        diseases;
            (B) ten centers for basic and clinical research 
        into, training in, and demonstration of, advanced 
        diagnostic, prevention, and treatment and 
        rehabilitation methods (including methods of providing 
        emergency medical services) for lung diseases 
        (including bronchitis, emphysema, asthma, cystic 
        fibrosis, and other lung diseases of children);
            (C) ten centers for basic and clinical research 
        into, training in, and demonstration of, advanced 
        diagnostic, prevention, and treatment methods 
        (including methods of providing emergency medical 
        services) for blood diseases and research into blood, 
        in the use of blood products and in the management of 
        blood resources; and
            (D) three centers for basic and clinical research 
        into, training in, and demonstration of, advanced 
        diagnostic, prevention, and treatment (including 
        genetic studies, intrauterine environment studies, 
        postnatal studies, heart arrhythmias, and acquired 
        heart disease and preventive cardiology) for 
        cardiovascular diseases in children.
    (2) The centers developed under paragraph (1) shall, in 
addition to being utilized for research, training, and 
demonstrations, be utilized for the following prevention 
programs for cardiovascular, pulmonary, and blood diseases:
            (A) Programs to develop improved methods of 
        detecting individuals with a high risk of developing 
        cardiovascular, pulmonary, and blood diseases.
            (B) Programs to develop improved methods of 
        intervention against those factors which cause 
        individuals to have a high risk of developing such 
        diseases.
            (C) Programs to develop health professions and 
        allied health professions personnel highly skilled in 
        the prevention of such diseases.
            (D) Programs to develop improved methods of 
        providing emergency medical services for persons with 
        such diseases.
            (E) Programs of continuing education for health and 
        allied health professionals in the diagnosis, 
        prevention, and treatment of such diseases and the 
        maintenance of health to reduce the incidence of such 
        diseases and information programs for the public 
        respecting the prevention and early diagnosis and 
        treatment of such diseases and the maintenance of 
        health.
    (3) The research, training, and demonstration activities 
carried out through any such center may relate to any one or 
more of the diseases referred to in paragraph (1) of this 
subsection.
    (b) The Director of the Institute shall provide, in 
accordance with subsection (c), for the development of ten 
centers for basic and clinical research into the diagnosis, 
treatment, and control of sickle cell anemia.
    (c)(1) The Director of the Institute may enter into 
cooperative agreements with and make grants to public or 
private nonprofit entities to pay all or part of the cost of 
planning, establishing, or strengthening, and providing basic 
operating support for centers for basic and clinical research 
into, training in, and demonstration of the management of blood 
resources and advanced diagnostic, prevention, and treatment 
methods for heart, blood vessel, lung, or blood diseases.
    (2) A cooperative agreement or grant under paragraph (1) 
shall be entered into in accordance with policies established 
by the Director of NIH and after consultation with the 
Institute's advisory council.
    (3) Federal payments made under a cooperative agreement or 
grant under paragraph (1) may be used for--
            (A) construction (notwithstanding any limitation 
        under section 496);
            (B) staffing and other basic operating costs, 
        including such patient care costs as are required for 
        research;
            (C) training, including training for allied health 
        professionals; and
            (D) demonstration purposes.
As used in this subsection, the term ``construction'' does not 
include the acquisition of land, and the term ``training'' does 
not include research training for which National Research 
Service Awards \1\ may be provided under section 487.
---------------------------------------------------------------------------
    \1\ Now Ruth L. Kirschstein National Research Service Awards. See 
section 487.
---------------------------------------------------------------------------
    (4) Support of a center under paragraph (1) may be for a 
period of not to exceed five years. Such period may be extended 
by the Director for additional periods of not more than five 
years each if the operations of such center have been reviewed 
by an appropriate technical and scientific peer review group 
established by the Director and if such group has recommended 
to the Director that such period should be extended.

                   associate director for prevention

    Sec. 423. [285b-6] (a) There shall be in the Institute an 
Associate Director for Prevention to coordinate and promote the 
programs in the Institute concerning the prevention of heart, 
blood vessel, lung, and blood diseases. The Associate Director 
shall be appointed by the Director of the Institute from 
individuals who because of their professional training or 
experience are experts in public health or preventive medicine.
    (b) The Associate Director for Prevention shall prepare for 
inclusion in the biennial report made under section 407 a 
description of the prevention activities of the Institute, 
including a description of the staff and resources allocated to 
those activities.

              NATIONAL CENTER ON SLEEP DISORDERS RESEARCH

    Sec. 424. [285b-7] (a) Not later than 1 year after the date 
of the enactment of the National Institutes of Health 
Revitalization Act of 1993, the Director of the Institute shall 
establish the National Center on Sleep Disorders Research (in 
this section referred to as the ``Center''). The Center shall 
be headed by a director, who shall be appointed by the Director 
of the Institute.
    (b) The general purpose of the Center is--
            (1) the conduct and support of research, training, 
        health information dissemination, and other activities 
        with respect to sleep disorders, including biological 
        and circadian rhythm research, basic understanding of 
        sleep, chronobiological and other sleep related 
        research; and
            (2) to coordinate the activities of the Center with 
        similar activities of other Federal agencies, including 
        the other agencies of the National Institutes of 
        Health, and similar activities of other public entities 
        and nonprofit entities.
    (c)(1) The Director of the National Institutes of Health 
shall establish a board to be known as the Sleep Disorders 
Research Advisory Board (in this section referred to as the 
``Advisory Board'').
    (2) The Advisory Board shall advise, assist, consult with, 
and make recommendations to the Director of the National 
Institutes of Health, through the Director of the Institute, 
and the Director of the Center concerning matters relating to 
the scientific activities carried out by and through the Center 
and the policies respecting such activities, including 
recommendations with respect to the plan required in subsection 
(c) \1\.
---------------------------------------------------------------------------
    \1\ So in law. See section 503 of Public Law 103-43 (107 Stat. 
159). Probably should be ``subsection (d)''.
---------------------------------------------------------------------------
    (3)(A) The Director of the National Institutes of Health 
shall appoint to the Advisory Board 12 appropriately qualified 
representatives of the public who are not officers or employees 
of the Federal Government. Of such members, eight shall be 
representatives of health and scientific disciplines with 
respect to sleep disorders and four shall be individuals 
representing the interests of individuals with or undergoing 
treatment for sleep disorders.
    (B) The following officials shall serve as ex officio 
members of the Advisory Board:
            (i) The Director of the National Institutes of 
        Health.
            (ii) The Director of the Center.
            (iii) The Director of the National Heart, Lung and 
        Blood Institute.
            (iv) The Director of the National Institute of 
        Mental Health.
            (v) The Director of the National Institute on 
        Aging.
            (vi) The Director of the Eunice Kennedy Shriver 
        National Institute of Child Health and Human 
        Development.
            (vii) The Director of the National Institute of 
        Neurological Disorders and Stroke.
            (viii) The Assistant Secretary for Health.
            (ix) The Assistant Secretary of Defense (Health 
        Affairs).
            (x) The Chief Medical Director of the Veterans' 
        Administration.
    (4) The members of the Advisory Board shall, from among the 
members of the Advisory Board, designate an individual to serve 
as the chair of the Advisory Board.
    (5) Except as inconsistent with, or inapplicable to, this 
section, the provisions of section 406 shall apply to the 
advisory board \2\ established under this section in the same 
manner as such provisions apply to any advisory council 
established under such section.
---------------------------------------------------------------------------
    \2\ So in law. See section 503 of Public Law 103-43 (107 Stat. 
159). Probably should be capitalized.
---------------------------------------------------------------------------
    (d)(1) After consultation with the Director of the Center 
and the advisory board established under subsection (c), the 
Director of the National Institutes of Health shall develop a 
comprehensive plan for the conduct and support of sleep 
disorders research.
    (2) The plan developed under paragraph (1) shall identify 
priorities with respect to such research and shall provide for 
the coordination of such research conducted or supported by the 
agencies of the National Institutes of Health.
    (3) The Director of the National Institutes of Health 
(after consultation with the Director of the Center and the 
advisory board established under subsection (c)) shall revise 
the plan developed under paragraph (1) as appropriate.
    (e) The Director of the Center, in cooperation with the 
Centers for Disease Control and Prevention, is authorized to 
coordinate activities with the Department of Transportation, 
the Department of Defense, the Department of Education, the 
Department of Labor, and the Department of Commerce to collect 
data, conduct studies, and disseminate public information 
concerning the impact of sleep disorders and sleep deprivation.

    HEART ATTACK, STROKE, AND OTHER CARDIOVASCULAR DISEASES IN WOMEN

    Sec. 424A. [285b-7a] (a) In General.--The Director of the 
Institute shall expand, intensify, and coordinate research and 
related activities of the Institute with respect to heart 
attack, stroke, and other cardiovascular diseases in women.
    (b) Coordination With Other Institutes.--The Director of 
the Institute shall coordinate activities under subsection (a) 
with similar activities conducted by the other national 
research institutes and agencies of the National Institutes of 
Health to the extent that such Institutes and agencies have 
responsibilities that are related to heart attack, stroke, and 
other cardiovascular diseases in women.
    (c) Certain Programs.--In carrying out subsection (a), the 
Director of the Institute shall conduct or support research to 
expand the understanding of the causes of, and to develop 
methods for preventing, cardiovascular diseases in women. 
Activities under such subsection shall include conducting and 
supporting the following:
            (1) Research to determine the reasons underlying 
        the prevalence of heart attack, stroke, and other 
        cardiovascular diseases in women, including African-
        American women and other women who are members of 
        racial or ethnic minority groups.
            (2) Basic research concerning the etiology and 
        causes of cardiovascular diseases in women.
            (3) Epidemiological studies to address the 
        frequency and natural history of such diseases and the 
        differences among men and women, and among racial and 
        ethnic groups, with respect to such diseases.
            (4) The development of safe, efficient, and cost-
        effective diagnostic approaches to evaluating women 
        with suspected ischemic heart disease.
            (5) Clinical research for the development and 
        evaluation of new treatments for women, including 
        rehabilitation.
            (6) Studies to gain a better understanding of 
        methods of preventing cardiovascular diseases in women, 
        including applications of effective methods for the 
        control of blood pressure, lipids, and obesity.
            (7) Information and education programs for patients 
        and health care providers on risk factors associated 
        with heart attack, stroke, and other cardiovascular 
        diseases in women, and on the importance of the 
        prevention or control of such risk factors and timely 
        referral with appropriate diagnosis and treatment. Such 
        programs shall include information and education on 
        health-related behaviors that can improve such 
        important risk factors as smoking, obesity, high blood 
        cholesterol, and lack of exercise.

               COORDINATION OF FEDERAL ASTHMA ACTIVITIES

    Sec. 424B \1\ [285b-7b] (a) In General.--The Director of 
Institute shall, through the National Asthma Education 
Prevention Program Coordinating Committee--
---------------------------------------------------------------------------
    \1\ So in law. The section designation lacks a period. See section 
521 of Public Law 106-310 (114 Stat. 1116).
---------------------------------------------------------------------------
            (1) identify all Federal programs that carry out 
        asthma-related activities; and
            (2) develop, in consultation with appropriate 
        Federal agencies and professional and voluntary health 
        organizations, a Federal plan for responding to asthma.
    (b) Representation of the Department of Housing and Urban 
Development.--A representative of the Department of Housing and 
Urban Development shall be included on the National Asthma 
Education Prevention Program Coordinating Committee for the 
purpose of performing the tasks described in subsection (a). 
\1\
---------------------------------------------------------------------------
    \1\ Section 425 was repealed by section 103(b)(20) of Public Law 
109-482 (120 Stat. 3688).
---------------------------------------------------------------------------

SEC. 424C. [285B-7C] TUBERCULOSIS.

    (a) In General.--The Director of the National Institutes of 
Health may expand, intensify, and coordinate research and 
development and related activities of the Institutes with 
respect to tuberculosis including activities toward the goal of 
eliminating such disease.
    (b) Certain Activities.--Activities under subsection (a) 
may include--
            (1) enhancing basic and clinical research on 
        tuberculosis, including drug resistant tuberculosis;
            (2) expanding research on the relationship between 
        such disease and the human immunodeficiency virus; and
            (3) developing new tools for the elimination of 
        tuberculosis, including public health interventions and 
        methods to enhance detection and response to outbreaks 
        of tuberculosis, including multidrug resistant 
        tuberculosis.

SEC. 425. [285B-8] CONGENITAL HEART DISEASE.

    (a) In General.--The Director of the Institute may expand, 
intensify, and coordinate research and related activities of 
the Institute with respect to congenital heart disease, which 
may include congenital heart disease research with respect to--
            (1) causation of congenital heart disease, 
        including genetic causes;
            (2) long-term outcomes in individuals with 
        congenital heart disease, including infants, children, 
        teenagers, adults, and elderly individuals;
            (3) diagnosis, treatment, and prevention;
            (4) studies using longitudinal data and 
        retrospective analysis to identify effective treatments 
        and outcomes for individuals with congenital heart 
        disease; and
            (5) identifying barriers to life-long care for 
        individuals with congenital heart disease.
    (b) Coordination of Research Activities.--The Director of 
the Institute may coordinate research efforts related to 
congenital heart disease among multiple research institutions 
and may develop research networks.
    (c) Minority and Medically Underserved Communities.--In 
carrying out the activities described in this section, the 
Director of the Institute shall consider the application of 
such research and other activities to minority and medically 
underserved communities.

  Subpart 3--National Institute of Diabetes and Digestive and Kidney 
                                Diseases

                        PURPOSE OF THE INSTITUTE

    Sec. 426. [285c] The general purpose of the National 
Institute of Diabetes and Digestive and Kidney Diseases 
(hereafter in this subpart referred to as the ``Institute'') is 
the conduct and support of research, training, health 
information dissemination, and other programs with respect to 
diabetes mellitus and endocrine and metabolic diseases, 
digestive diseases and nutritional disorders, and kidney, 
urologic, and hematologic diseases.

              DATA SYSTEMS AND INFORMATION CLEARINGHOUSES

    Sec. 427. [285c-1] (a) The Director of the Institute shall 
(1) establish the National Diabetes Data System for the 
collection, storage, analysis, retrieval, and dissemination of 
data derived from patient populations with diabetes, including, 
where possible, data involving general populations for the 
purpose of detection of individuals with a risk of developing 
diabetes, and (2) establish the National Diabetes Information 
Clearinghouse to facilitate and enhance knowledge and 
understanding of diabetes on the part of health professionals, 
patients, and the public through the effective dissemination of 
information.
    (b) The Director of the Institute shall (1) establish the 
National Digestive Diseases Data System for the collection, 
storage, analysis, retrieval, and dissemination of data derived 
from patient populations with digestive diseases, including, 
where possible, data involving general populations for the 
purpose of detection of individuals with a risk of developing 
digestive diseases, and (2) establish the National Digestive 
Diseases Information Clearinghouse to facilitate and enhance 
knowledge and understanding of digestive diseases on the part 
of health professionals, patients, and the public through the 
effective dissemination of information.
    (c) The Director of the Institute shall (1) establish the 
National Kidney and Urologic Diseases Data System for the 
collection, storage, analysis, retrieval, and dissemination of 
data derived from patient populations with kidney and urologic 
diseases, including, where possible, data involving general 
populations for the purpose of detection of individuals with a 
risk of developing kidney and urologic diseases, and (2) 
establish the National Kidney and Urologic Diseases Information 
Clearinghouse to facilitate and enhance knowledge and 
understanding of kidney and urologic diseases on the part of 
health professionals, patients, and the public through the 
effective dissemination of information.

DIVISION DIRECTORS FOR DIABETES, ENDOCRINOLOGY, AND METABOLIC DISEASES, 
DIGESTIVE DISEASES AND NUTRITION, AND KIDNEY, UROLOGIC, AND HEMATOLOGIC 
                                DISEASES

    Sec. 428. [285c-2] (a)(1) In the Institute there shall be a 
Division Director for Diabetes, Endocrinology, and Metabolic 
Diseases, a Division Director for Digestive Diseases and 
Nutrition, and a Division Director for Kidney, Urologic, and 
Hematologic Diseases. Such Division Directors, under the 
supervision of the Director of the Institute, shall be 
responsible for--
            (A) developing a coordinated plan (including 
        recommendations for expenditures) for each of the 
        national research institutes within the National 
        Institutes of Health with respect to research and 
        training concerning diabetes, endocrine and metabolic 
        diseases, digestive diseases and nutrition, and kidney, 
        urologic, and hematologic diseases;
            (B) assessing the adequacy of management approaches 
        for the activities within such institutes concerning 
        such diseases and nutrition and developing improved 
        approaches if needed;
            (C) monitoring and reviewing expenditures by such 
        institutes concerning such diseases and nutrition; and
            (D) identifying research opportunities concerning 
        such diseases and nutrition and recommending ways to 
        utilize such opportunities.
    (2) The Director of the Institute shall transmit to the 
Director of NIH the plans, recommendations, and reviews of the 
Division Directors under subparagraphs (A) through (D) of 
paragraph (1) together with such comments and recommendations 
as the Director of the Institute determines appropriate.
    (b) The Director of the Institute, acting through the 
Division Director for Diabetes, Endocrinology, and Metabolic 
Diseases, the Division Director for Digestive Diseases and 
Nutrition, and the Division Director for Kidney, Urologic, and 
Hematologic Diseases, shall--
            (1) carry out programs of support for research and 
        training (other than training for which National 
        Research Service Awards \1\ may be made under section 
        487) in the diagnosis, prevention, and treatment of 
        diabetes mellitus and endocrine and metabolic diseases, 
        digestive diseases and nutritional disorders, and 
        kidney, urologic, and hematologic diseases, including 
        support for training in medical schools, graduate 
        clinical training, graduate training in epidemiology, 
        epidemiology studies, clinical trials, and 
        interdisciplinary research programs; and
---------------------------------------------------------------------------
    \1\ Now Ruth L. Kirschstein National Research Service Awards. See 
section 487.
---------------------------------------------------------------------------
            (2) establish programs of evaluation, planning, and 
        dissemination of knowledge related to such research and 
        training.

                  INTERAGENCY COORDINATING COMMITTEES

    Sec. 429. [285c-3] (a) For the purpose of--
            (1) better coordination of the research activities 
        of all the national research institutes relating to 
        diabetes mellitus, digestive diseases, and kidney, 
        urologic, and hematologic diseases; and
            (2) coordinating those aspects of all Federal 
        health programs and activities relating to such 
        diseases to assure the adequacy and technical soundness 
        of such programs and activities and to provide for the 
        full communication and exchange of information 
        necessary to maintain adequate coordination of such 
        programs and activities;
the Secretary shall establish a Diabetes Mellitus Interagency 
Coordinating Committee, a Digestive Diseases Interagency 
Coordinating Committee, and a Kidney, Urologic, and Hematologic 
Diseases Coordinating Committee (hereafter in this section 
individually referred to as a ``Committee'').
    (b) Each Committee shall be composed of the Directors of 
each of the national research institutes and divisions involved 
in research with respect to the diseases for which the 
Committee is established, the Division Director of the 
Institute for the diseases for which the Committee is 
established, the Chief Medical Director of the Veterans' 
Administration, and the Assistant Secretary of Defense for 
Health Affairs (or the designees of such officers) and shall 
include representation from all other Federal departments and 
agencies whose programs involve health functions or 
responsibilities relevant to such diseases, as determined by 
the Secretary. Each Committee shall be chaired by the Director 
of NIH (or the designee of the Director). Each Committee shall 
meet at the call of the chairman, but not less often than four 
times a year.

                            ADVISORY BOARDS

    Sec. 430. [285c-4] (a) The Secretary shall establish in the 
Institute the National Diabetes Advisory Board, the National 
Digestive Diseases Advisory Board, and the National Kidney and 
Urologic Diseases Advisory Board (hereafter in this section 
individually referred to as an ``Advisory Board'').
    (b) Each Advisory Board shall be composed of eighteen 
appointed members and nonvoting ex officio members as follows:
            (1) The Secretary shall appoint--
                    (A) twelve members from individuals who are 
                scientists, physicians, and other health 
                professionals, who are not officers or 
                employees of the United States, and who 
                represent the specialties and disciplines 
                relevant to the diseases with respect to which 
                the Advisory Board is established; and
                    (B) six members from the general public who 
                are knowledgeable with respect to such 
                diseases, including at least one member who is 
                a person who has such a disease and one member 
                who is a parent of a person who has such a 
                disease.
        Of the appointed members at least five shall by virtue 
        of training or experience be knowledgeable in the 
        fields of health education, nursing, data systems, 
        public information, and community program development.
            (2)(A) The following shall be ex officio members of 
        each Advisory Board:
                    (i) The Assistant Secretary for Health, the 
                Director of NIH, the Director of the National 
                Institute of Diabetes and Digestive and Kidney 
                Diseases, the Director of the Centers for 
                Disease Control and Prevention, the Chief 
                Medical Director of the Department of Veterans 
                Affairs, the Assistant Secretary of Defense for 
                Health Affairs, and the Division Director of 
                the National Institute of Diabetes and 
                Digestive and Kidney Diseases for the diseases 
                for which the Board is established (or the 
                designees of such officers).
                    (ii) Such other officers and employees of 
                the United States as the Secretary determines 
                necessary for the Advisory Board to carry out 
                its functions.
            (B) In the case of the National Diabetes Advisory 
        Board, the following shall also be ex officio members: 
        The Director of the National Heart, Lung, and Blood 
        Institute, the Director of the National Eye Institute, 
        the Director of the Eunice Kennedy Shriver National 
        Institute of Child Health and Human Development, and 
        the Administrator of the Health Resources and Services 
        Administration (or the designees of such officers).
    (c) Members of an Advisory Board who are officers or 
employees of the Federal Government shall serve as members of 
the Advisory Board without compensation in addition to that 
received in their regular public employment. Other members of 
the Board shall receive compensation at rates not to exceed the 
daily equivalent of the annual rate in effect for grade GS-18 
of the General Schedule for each day (including traveltime) 
they are engaged in the performance of their duties as members 
of the Board.
    (d) The term of office of an appointed member of an 
Advisory Board is four years, except that no term of office may 
extend beyond the expiration of the Advisory Board. Any member 
appointed to fill a vacancy for an unexpired term shall be 
appointed for the remainder of such term. A member may serve 
after the expiration of the member's term until a successor has 
taken office. If a vacancy occurs in an Advisory Board, the 
Secretary shall make an appointment to fill the vacancy not 
later than 90 days from the date the vacancy occurred.
    (e) The members of each Advisory Board shall select a 
chairman from among the appointed members.
    (f) The Secretary shall, after consultation with and 
consideration of the recommendations of an Advisory Board, 
provide the Advisory Board with an executive director and one 
other professional staff member. In addition, the Secretary 
shall, after consultation with and consideration of the 
recommendations of the Advisory Board, provide the Advisory 
Board with such additional professional staff members, such 
clerical staff members, such services of consultants, such 
information, and (through contracts or other arrangements) such 
administrative support services and facilities, as the 
Secretary determines are necessary for the Advisory Board to 
carry out its functions.
    (g) Each Advisory Board shall meet at the call of the 
chairman or upon request of the Director of the Institute, but 
not less often than four times a year.
    (h) The National Diabetes Advisory Board and the National 
Digestive Diseases Advisory Board shall--
            (1) review and evaluate the implementation of the 
        plan (referred to in section 433) respecting the 
        diseases with respect to which the Advisory Board was 
        established and periodically update the plan to ensure 
        its continuing relevance;
            (2) for the purpose of assuring the most effective 
        use and organization of resources respecting such 
        diseases, advise and make recommendations to the 
        Congress, the Secretary, the Director of NIH, the 
        Director of the Institute, and the heads of other 
        appropriate Federal agencies for the implementation and 
        revision of such plan; and
            (3) maintain liaison with other advisory bodies 
        related to Federal agencies involved in the 
        implementation of such plan, the coordinating committee 
        for such diseases, and with key non-Federal entities 
        involved in activities affecting the control of such 
        diseases.
    (i) In carrying out its functions, each Advisory Board may 
establish subcommittees, convene workshops and conferences, and 
collect data. Such subcommittees may be composed of Advisory 
Board members and nonmember consultants with expertise in the 
particular area addressed by such subcommittees. The 
subcommittees may hold such meetings as are necessary to enable 
them to carry out their activities.
    (j) The National Diabetes Advisory Board and the National 
Digestive Diseases Advisory Board in existence on the date of 
enactment of the Health Research Extension Act of 1985 shall 
terminate upon the appointment of a successor Board under 
subsection (a). The Secretary shall make appointments to the 
Advisory Boards established under subsection (a) before the 
expiration of 90 days after such date. The members of the 
Boards in existence on such date may be appointed, in 
accordance with subsections (b) and (d), to the Boards 
established under subsection (a) for diabetes and digestive 
diseases, except that at least one-half of the members of the 
National Diabetes Advisory Board in existence on the date of 
enactment of the Health Research Extension Act of 1985 shall be 
appointed to the National Diabetes Advisory Board first 
established under subsection (a).

                     RESEARCH AND TRAINING CENTERS

    Sec. 431. [285c-5] (a)(1) Consistent with applicable 
recommendations of the National Commission on Diabetes, the 
Director of the Institute shall provide for the development or 
substantial expansion of centers for research and training in 
diabetes mellitus and related endocrine and metabolic diseases. 
Each center developed or expanded under this subsection shall--
            (A) utilize the facilities of a single institution, 
        or be formed from a consortium of cooperating 
        institutions, meeting such research and training 
        qualifications as may be prescribed by the Secretary; 
        and
            (B) conduct--
                    (i) research in the diagnosis and treatment 
                of diabetes mellitus and related endocrine and 
                metabolic diseases and the complications 
                resulting from such diseases;
                    (ii) training programs for physicians and 
                allied health personnel in current methods of 
                diagnosis and treatment of such diseases and 
                complications, and in research in diabetes; and
                    (iii) information programs for physicians 
                and allied health personnel who provide primary 
                care for patients with such diseases or 
                complications.
    (2) A center may use funds provided under paragraph (1) to 
provide stipends for nurses and allied health professionals 
enrolled in research training programs described in paragraph 
(1)(B)(ii).
    (b) Consistent with applicable recommendations of the 
National Digestive Diseases Advisory Board, the Director shall 
provide for the development or substantial expansion of centers 
for research in digestive diseases and related functional, 
congenital, metabolic disorders, and normal development of the 
digestive tract. Each center developed or expanded under this 
subsection--
            (1) shall utilize the facilities of a single 
        institution, or be formed from a consortium of 
        cooperating institutions, meeting such research 
        qualifications as may be prescribed by the Secretary;
            (2) shall develop and conduct basic and clinical 
        research into the cause, diagnosis, early detection, 
        prevention, control, and treatment of digestive 
        diseases and nutritional disorders and related 
        functional, congenital, or metabolic complications 
        resulting from such diseases or disorders;
            (3) shall encourage research into and programs 
        for--
                    (A) providing information for patients with 
                such diseases and the families of such 
                patients, physicians and others who care for 
                such patients, and the general public;
                    (B) model programs for cost effective and 
                preventive patient care; and
                    (C) training physicians and scientists in 
                research on such diseases, disorders, and 
                complications; and
            (4) may perform research and participate in 
        epidemiological studies and data collection relevant to 
        digestive diseases and disorders and disseminate such 
        research, studies, and data to the health care 
        profession and to the public.
    (c) The Director shall provide for the development or 
substantial expansion of centers for research in kidney and 
urologic diseases. Each center developed or expanded under this 
subsection--
            (1) shall utilize the facilities of a single 
        institution, or be formed from a consortium of 
        cooperating institutions, meeting such research 
        qualifications as may be prescribed by the Secretary;
          shall develop and conduct basic and clinical research 
        into the cause, diagnosis, early detection, prevention, 
        control, and treatment of kidney and urologic diseases;
            (3) shall encourage research into and programs 
        for--
                    (A) providing information for patients with 
                such diseases, disorders, and complications and 
                the families of such patients, physicians and 
                others who care for such patients, and the 
                general public;
                    (B) model programs for cost effective and 
                preventive patient care; and
                    (C) training physicians and scientists in 
                research on such diseases; and
            (4) may perform research and participate in 
        epidemiological studies and data collection relevant to 
        kidney and urologic diseases in order to disseminate 
        such research, studies, and data to the health care 
        profession and to the public.
    (d)(1) The Director of the Institute shall, subject to the 
extent of amounts made available in appropriations Acts, 
provide for the development or substantial expansion of centers 
for research and training regarding nutritional disorders, 
including obesity.
    (2) The Director of the Institute shall carry out paragraph 
(1) in collaboration with the Director of the National Cancer 
Institute and with the Directors of such other agencies of the 
National Institutes of Health as the Director of NIH determines 
to be appropriate.
    (3) Each center developed or expanded under paragraph (1) 
shall--
            (A) utilize the facilities of a single institution, 
        or be formed from a consortium of cooperating 
        institutions, meeting such research and training 
        qualifications as may be prescribed by the Director;
            (B) conduct basic and clinical research into the 
        cause, diagnosis, early detection, prevention, control 
        and treatment of nutritional disorders, including 
        obesity and the impact of nutrition and diet on child 
        development;
            (C) conduct training programs for physicians and 
        allied health professionals in current methods of 
        diagnosis and treatment of such diseases and 
        complications, and in research in such disorders; and
            (D) conduct information programs for physicians and 
        allied health professionals who provide primary care 
        for patients with such disorders or complications.
    (e) Insofar as practicable, centers developed or expanded 
under this section should be geographically dispersed 
throughout the United States and in environments with proven 
research capabilities. Support of a center under this section 
may be for a period of not to exceed five years and such period 
may be extended by the Director of the Institute for additional 
periods of not more than five years each if the operations of 
such center have been reviewed by an appropriate technical and 
scientific peer review group established by the Director and if 
such group has recommended to the Director that such period 
should be extended.

                     ADVISORY COUNCIL SUBCOMMITTEES

    Sec. 432. [285c-6] There are established within the 
advisory council for the Institute appointed under section 406 
a subcommittee on diabetes and endocrine and metabolic 
diseases, a subcommittee on digestive diseases and nutrition, 
and a subcommittee on kidney, urologic, and hematologic 
diseases. The subcommittees shall be composed of members of the 
advisory council who are outstanding in the diagnosis, 
prevention, and treatment of the diseases for which the 
subcommittees are established and members of the advisory 
council who are leaders in the fields of education and public 
affairs. The subcommittees are authorized to review 
applications made to the Director of the Institute for grants 
for research and training projects relating to the diagnosis, 
prevention, and treatment of the diseases for which the 
subcommittees are established and shall recommend to the 
advisory council those applications and contracts that the 
subcommittees determine will best carry out the purposes of the 
Institute. The subcommittees shall also review and evaluate the 
diabetes and endocrine and metabolic diseases, digestive 
diseases and nutrition, and kidney, urologic, and hematologic 
diseases programs of the Institute and recommend to the 
advisory council such changes in the administration of such 
programs as the subcommittees determine are necessary.

                            BIENNIAL REPORT

    Sec. 433. [285c-7] The Director of the Institute shall 
prepare for inclusion in the biennial report made under section 
407 a description of the Institute's activities--
            (1) under the current diabetes plan under the 
        National Diabetes Mellitus Research and Education Act; 
        and
            (2) under the current digestive diseases plan 
        formulated under the Arthritis, Diabetes, and Digestive 
        Diseases Amendments of 1976.
The description submitted by the Director shall include an 
evaluation of the activities of the centers supported under 
section 431.

             H3  deg.NUTRITIONAL DISORDERS PROGRAM

    Sec. 434. [285c-8] (a) The Director of the Institute, in 
consultation with the Director of NIH, shall establish a 
program of conducting and supporting research, training, health 
information dissemination, and other activities with respect to 
nutritional disorders, including obesity.
    (b) In carrying out the program established under 
subsection (a), the Director of the Institute shall conduct and 
support each of the activities described in such subsection.
    (c) In carrying out the program established under 
subsection (a), the Director of the Institute shall carry out 
activities to facilitate and enhance knowledge and 
understanding of nutritional disorders, including obesity, on 
the part of health professionals, patients, and the public 
through the effective dissemination of information.

                           JUVENILE DIABETES

    Sec. 434A. [285c-9] (a) Long-Term Epidemiology Studies.--
The Director of the Institute shall conduct or support long-
term epidemiology studies in which individuals with or at risk 
for type 1, or juvenile, diabetes are followed for 10 years or 
more. Such studies shall investigate the causes and 
characteristics of the disease and its complications.
    (b) Clinical Trial Infrastructure/Innovative Treatments for 
Juvenile Diabetes.--The Secretary, acting through the Director 
of the National Institutes of Health, shall support regional 
clinical research centers for the prevention, detection, 
treatment, and cure of juvenile diabetes.
    (c) Prevention of Type 1 Diabetes.--The Secretary, acting 
through the appropriate agencies, shall provide for a national 
effort to prevent type 1 diabetes. Such effort shall provide 
for a combination of increased efforts in research and 
development of prevention strategies, including consideration 
of vaccine development, coupled with appropriate ability to 
test the effectiveness of such strategies in large clinical 
trials of children and young adults.

Subpart 4--National Institute of Arthritis and Musculoskeletal and Skin 
                                Diseases

                        PURPOSE OF THE INSTITUTE

    Sec. 435. [285d] The general purpose of the National 
Institute of Arthritis and Musculoskeletal and Skin Diseases 
(hereafter in this subpart referred to as the ``Institute'') is 
the conduct and support of research and training, the 
dissemination of health information, and other programs with 
respect to arthritis and musculoskeletal and skin diseases 
(including sports-related disorders), with particular attention 
to the effect of these diseases on children.* deg.

    NATIONAL ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES PROGRAM

    Sec. 436. [285d-1] (a) The Director of the Institute, with 
the advice of the Institute's advisory council, shall prepare 
and transmit to the Director of NIH a plan for a national 
arthritis and musculoskeletal and skin diseases program to 
expand, intensify, and coordinate the activities of the 
Institute respecting arthritis and musculoskeletal and skin 
diseases. The plan shall include such comments and 
recommendations as the Director of the Institute determines 
appropriate. The plan shall place particular emphasis upon 
expanding research into better understanding the causes and the 
development of effective treatments for arthritis affecting 
children. The Director of the Institute shall periodically 
review and revise such plan and shall transmit any revisions of 
such plan to the Director of NIH.
    (b) Activities under the national arthritis and 
musculoskeletal and skin diseases program shall be coordinated 
with the other national research institutes to the extent that 
such institutes have responsibilities respecting arthritis and 
musculoskeletal and skin diseases, and shall, at least, provide 
for--
            (1) investigation into the epidemiology, etiology, 
        and prevention of all forms of arthritis and 
        musculoskeletal and skin diseases, including sports-
        related disorders, primarily through the support of 
        basic research in such areas as immunology, genetics, 
        biochemistry, microbiology, physiology, bioengineering, 
        and any other scientific discipline which can 
        contribute important knowledge to the treatment and 
        understanding of arthritis and musculoskeletal and skin 
        diseases;
            (2) research into the development, trial, and 
        evaluation of techniques, drugs, and devices used in 
        the diagnosis, treatment, including medical 
        rehabilitation, and prevention of arthritis and 
        musculoskeletal and skin diseases;
            (3) research on the refinement, development, and 
        evaluation of technological devices that will replace 
        or be a substitute for damaged bone, muscle, and joints 
        and other supporting structures;
            (4) the establishment of mechanisms to monitor the 
        causes of athletic injuries and identify ways of 
        preventing such injuries on scholastic athletic fields; 
        and
            (5) research into the causes of arthritis affecting 
        children and the development, trial, and evaluation of 
        techniques, drugs and devices used in the diagnosis, 
        treatment (including medical rehabilitation), and 
        prevention of arthritis in children.
    (c) The Director of the Institute shall carry out the 
national arthritis and musculoskeletal and skin diseases 
program in accordance with the plan prepared under subsection 
(a) and any revisions of such plan made under such subsection.

                         RESEARCH AND TRAINING

    Sec. 437. [285d-2] The Director of the Institute shall--
            (1) carry out programs of support for research and 
        training (other than training for which National 
        Research Service Awards \1\ may be made under section 
        487) in the diagnosis, prevention, and treatment of 
        arthritis and musculoskeletal and skin diseases, 
        including support for training in medical schools, 
        graduate clinical training, graduate training in 
        epidemiology, epidemiology studies, clinical trials, 
        and interdisciplinary research programs; and
---------------------------------------------------------------------------
    \1\ Now Ruth L. Kirschstein National Research Service Awards. See 
section 487.
---------------------------------------------------------------------------
            (2) establish programs of evaluation, planning, and 
        dissemination of knowledge related to such research and 
        training.

               DATA SYSTEM AND INFORMATION CLEARINGHOUSE

    Sec. 438. [285d-3] (a) The Director of the Institute shall 
establish the National Arthritis and Musculoskeletal and Skin 
Diseases Data System for the collection, storage, analysis, 
retrieval, and dissemination of data derived from patient 
populations with arthritis and musculoskeletal and skin 
diseases, including where possible, data involving general 
populations for the purpose of detection of individuals with a 
risk of developing arthritis and musculoskeletal and skin 
diseases.
    (b) The Director of the Institute shall establish the 
National Arthritis and Musculoskeletal and Skin Diseases 
Information Clearinghouse to facilitate and enhance, through 
the effective dissemination of information, knowledge and 
understanding of arthritis and musculoskeletal and skin 
diseases, including juvenile arthritis and related conditions, 
by health professionals, patients, and the public.

                  INTERAGENCY COORDINATING COMMITTEES

    Sec. 439. [285d-4] (a) For the purpose of--
            (1) better coordination of the research activities 
        of all the national research institutes relating to 
        arthritis, musculoskeletal diseases, and skin diseases, 
        including sports-related disorders; and
            (2) coordinating the aspects of all Federal health 
        programs and activities relating to arthritis, 
        musculoskeletal diseases, and skin diseases in order to 
        assure the adequacy and technical soundness of such 
        programs and activities and in order to provide for the 
        full communication and exchange of information 
        necessary to maintain adequate coordination of such 
        programs and activities,
the Secretary shall establish an Arthritis and Musculoskeletal 
Diseases Interagency Coordinating Committee and a Skin Diseases 
Interagency Coordinating Committee (hereafter in this section 
individually referred to as a ``Committee'').
    (b) Each Committee shall be composed of the Directors of 
each of the national research institutes and divisions involved 
in research regarding the diseases with respect to which the 
Committee is established, the Chief Medical Director of the 
Department of Veterans Affairs, and the Assistant Secretary of 
Defense for Health Affairs (or the designees of such officers), 
and representatives of all other Federal departments and 
agencies (as determined by the Secretary) whose programs 
involve health functions or responsibilities relevant to 
arthritis and musculoskeletal diseases or skin diseases, as the 
case may be. Each Committee shall be chaired by the Director of 
NIH (or the designee of the Director). Each Committee shall 
meet at the call of the chairman, but not less often than four 
times a year.

     ARTHRITIS AND MUSCULOSKELETAL DISEASES DEMONSTRATION PROJECTS

    Sec. 440. [285d-5] (a) The Director of the Institute may 
make grants to public and private nonprofit entities to 
establish and support projects for the development and 
demonstration of methods for screening, detection, and referral 
for treatment of arthritis and musculoskeletal diseases and for 
the dissemination of information on such methods to the health 
and allied health professions. Activities under such projects 
shall be coordinated with Federal, State, local, and regional 
health agencies, centers assisted under section 441, and the 
data system established under subsection (c).
    (b) Projects supported under this section shall include--
            (1) programs which emphasize the development and 
        demonstration of new and improved methods of screening 
        and early detection, referral for treatment, and 
        diagnosis of individuals with a risk of developing 
        arthritis and musculoskeletal diseases;
            (2) programs which emphasize the development and 
        demonstration of new and improved methods for patient 
        referral from local hospitals and physicians to 
        appropriate centers for early diagnosis and treatment;
            (3) programs which emphasize the development and 
        demonstration of new and improved means of 
        standardizing patient data and recordkeeping;
            (4) programs which emphasize the development and 
        demonstration of new and improved methods of 
        dissemination of knowledge about the programs, methods, 
        and means referred to in paragraphs (1), (2), and (3) 
        of this subsection to health and allied health 
        professionals;
            (5) programs which emphasize the development and 
        demonstration of new and improved methods for the 
        dissemination to the general public of information--
                    (A) on the importance of early detection of 
                arthritis and musculoskeletal diseases, of 
                seeking prompt treatment, and of following an 
                appropriate regimen; and
                    (B) to discourage the promotion and use of 
                unapproved and ineffective diagnostic, 
                preventive treatment, and control methods for 
                arthritis and unapproved and ineffective drugs 
                and devices for arthritis and musculoskeletal 
                diseases; and
            (6) projects for investigation into the 
        epidemiology of all forms and aspects of arthritis and 
        musculoskeletal diseases, including investigations into 
        the social, environmental, behavioral, nutritional, and 
        genetic determinants and influences involved in the 
        epidemiology of arthritis and musculoskeletal diseases.
    (c) The Director shall provide for the standardization of 
patient data and recordkeeping for the collection, storage, 
analysis, retrieval, and dissemination of such data in 
cooperation with projects assisted under this section, centers 
assisted under section 441, and other persons engaged in 
arthritis and musculoskeletal disease programs.

      MULTIPURPOSE ARTHRITIS AND MUSCULOSKELETAL DISEASES CENTERS

    Sec. 441. [285d-6] (a) The Director of the Institute shall, 
after consultation with the advisory council for the Institute, 
provide for the development, modernization, and operation 
(including staffing and other operating costs such as the costs 
of patient care required for research) of new and existing 
centers for arthritis and musculoskeletal diseases. For 
purposes of this section, the term ``modernization'' means the 
alteration, remodeling, improvement, expansion, and repair of 
existing buildings and the provision of equipment for such 
buildings to the extent necessary to make them suitable for use 
as centers described in the preceding sentence.
    (b) Each center assisted under this section shall--
            (1)(A) use the facilities of a single institution 
        or a consortium of cooperating institutions, and (B) 
        meet such qualifications as may be prescribed by the 
        Secretary; and
            (2) conduct--
                    (A) basic and clinical research into the 
                cause, diagnosis, early detection, prevention, 
                control, and treatment of and rehabilitation 
                from arthritis and musculoskeletal diseases and 
                complications resulting from arthritis and 
                musculoskeletal diseases, including research 
                into implantable biomaterials and biomechanical 
                and other orthopedic procedures;
                    (B) training programs for physicians, 
                scientists, and other health and allied health 
                professionals;
                    (C) information and continuing education 
                programs for physicians and other health and 
                allied health professionals who provide care 
                for patients with arthritis and musculoskeletal 
                diseases; and
                    (D) programs for the dissemination to the 
                general public of information--
                            (i) on the importance of early 
                        detection of arthritis and 
                        musculoskeletal diseases, of seeking 
                        prompt treatment, and of following an 
                        appropriate regimen; and
                            (ii) to discourage the promotion 
                        and use of unapproved and ineffective 
                        diagnostic, preventive, treatment, and 
                        control methods and unapproved and 
                        ineffective drugs and devices.
A center may use funds provided under subsection (a) to provide 
stipends for health professionals enrolled in training programs 
described in paragraph (2)(B).
    (c) Each center assisted under this section may conduct 
programs to--
            (1) establish the effectiveness of new and improved 
        methods of detection, referral, and diagnosis of 
        individuals with a risk of developing arthritis and 
        musculoskeletal diseases;
            (2) disseminate the results of research, screening, 
        and other activities, and develop means of 
        standardizing patient data and recordkeeping; and
            (3) develop community consultative services to 
        facilitate the referral of patients to centers for 
        treatment.
    (d) The Director of the Institute shall, insofar as 
practicable, provide for an equitable geographical distribution 
of centers assisted under this section. The Director shall give 
appropriate consideration to the need for centers especially 
suited to meeting the needs of children affected by arthritis 
and musculoskeletal diseases.
    (e) Support of a center under this section may be for a 
period of not to exceed five years. Such period may be extended 
by the Director of the Institute for one or more additional 
periods of not more than five years if the operations of such 
center have been reviewed by an appropriate technical and 
scientific peer review group established by the Director and if 
such group has recommended to the Director that such period 
should be extended.
    (f) Not later than October 1, 1993, the Director shall 
establish a multipurpose arthritis and musculoskeletal disease 
center for the purpose of expanding the level of research into 
the cause, diagnosis, early detection, prevention, control, and 
treatment of, and rehabilitation of children with arthritis and 
musculoskeletal diseases.

                                 LUPUS

    Sec. 441A. [285d-6a] (a) In General.--The Director of the 
Institute shall expand and intensify research and related 
activities of the Institute with respect to lupus.
    (b) Coordination With Other Institutes.--The Director of 
the Institute shall coordinate the activities of the Director 
under subsection (a) with similar activities conducted by the 
other national research institutes and agencies of the National 
Institutes of Health to the extent that such Institutes and 
agencies have responsibilities that are related to lupus.
    (c) Programs for Lupus.--In carrying out subsection (a), 
the Director of the Institute shall conduct or support research 
to expand the understanding of the causes of, and to find a 
cure for, lupus. Activities under such subsection shall include 
conducting and supporting the following:
            (1) Research to determine the reasons underlying 
        the elevated prevalence of lupus in women, including 
        African-American women.
            (2) Basic research concerning the etiology and 
        causes of the disease.
            (3) Epidemiological studies to address the 
        frequency and natural history of the disease and the 
        differences among the sexes and among racial and ethnic 
        groups with respect to the disease.
            (4) The development of improved diagnostic 
        techniques.
            (5) Clinical research for the development and 
        evaluation of new treatments, including new biological 
        agents.
            (6) Information and education programs for health 
        care professionals and the public.

                             ADVISORY BOARD

    Sec. 442. [285d-7] (a) The Secretary shall establish in the 
Institute the National Arthritis and Musculoskeletal and Skin 
Diseases Advisory Board (hereafter in this section referred to 
as the ``Advisory Board'').
    (b) The Advisory Board shall be composed of twenty 
appointed members and nonvoting, ex officio members, as 
follows:
            (1) The Secretary shall appoint--
                    (A) twelve members from individuals who are 
                scientists, physicians, and other health 
                professionals, who are not officers or 
                employees of the United States, and who 
                represent the specialties and disciplines 
                relevant to arthritis, musculoskeletal 
                diseases, and skin diseases; and
                    (B) eight members from the general public 
                who are knowledgeable with respect to such 
                diseases, including one member who is a person 
                who has such a disease, one person who is the 
                parent of an adult with such a disease, and two 
                members who are parents of children with 
                arthritis.
        Of the appointed members at least five shall by virtue 
        of training or experience be knowledgeable in health 
        education, nursing, data systems, public information, 
        or community program development.
            (2) The following shall be ex officio members of 
        the Advisory Board:
                    (A) the Assistant Secretary for Health, the 
                Director of NIH, the Director of the National 
                Institute of Arthritis and Musculoskeletal and 
                Skin Diseases, the Director of the Centers for 
                Disease Control and Prevention, the Chief 
                Medical Director of the Department of Veterans 
                Affairs, and the Assistant Secretary of Defense 
                for Health Affairs (or the designees of such 
                officers), and
                    (B) such other officers and employees of 
                the United States as the Secretary determines 
                necessary for the Advisory Board to carry out 
                its functions.
    (c) Members of the Advisory Board who are officers or 
employees of the Federal Government shall serve as members of 
the Advisory Board without compensation in addition to that 
received in their regular public employment. Other members of 
the Advisory Board shall receive compensation at rates not to 
exceed the daily equivalent of the annual rate in effect for 
grade GS-18 of the General Schedule for each day (including 
traveltime) they are engaged in the performance of their duties 
as members of the Advisory Board.
    (d) The term of office of an appointed member of the 
Advisory Board is four years. Any member appointed to fill a 
vacancy for an unexpired term shall be appointed for the 
remainder of such term. A member may serve after the expiration 
of the member's term until a successor has taken office. If a 
vacancy occurs in the Advisory Board, the Secretary shall make 
an appointment to fill the vacancy not later than 90 days after 
the date the vacancy occurred.
    (e) The members of the Advisory Board shall select a 
chairman from among the appointed members.
    (f) The Secretary shall, after consultation with and 
consideration of the recommendations of the Advisory Board, 
provide the Advisory Board with an executive director and one 
other professional staff member. In addition, the Secretary 
shall, after consultation with and consideration of the 
recommendations of the Advisory Board, provide the Advisory 
Board with such additional professional staff members, such 
clerical staff members, and (through contracts or other 
arrangements) with such administrative support services and 
facilities, such information, and such services of consultants, 
as the Secretary determines are necessary for the Advisory 
Board to carry out its functions.
    (g) The Advisory Board shall meet at the call of the 
chairman or upon request of the Director of the Institute, but 
not less often than four times a year.
    (h) The Advisory Board shall--
            (1) review and evaluate the implementation of the 
        plan prepared under section 436(a) and periodically 
        update the plan to ensure its continuing relevance;
            (2) for the purpose of assuring the most effective 
        use and organization of resources respecting arthritis, 
        musculoskeletal diseases and skin diseases, advise and 
        make recommendations to the Congress, the Secretary, 
        the Director of NIH, the Director of the Institute, and 
        the heads of other appropriate Federal agencies for the 
        implementation and revision of such plan; and
            (3) maintain liaison with other advisory bodies for 
        Federal agencies involved in the implementation of such 
        plan, the interagency coordinating committees for such 
        diseases established under section 439, and with key 
        non-Federal entities involved in activities affecting 
        the control of such diseases.
    (i) In carrying out its functions, the Advisory Board may 
establish subcommittees, convene workshops and conferences, and 
collect data. Such subcommittees may be composed of Advisory 
Board members and nonmember consultants with expertise in the 
particular area addressed by such subcommittees. The 
subcommittees may hold such meetings as are necessary to enable 
them to carry out their activities.
    (j) The National Arthritis Advisory Board in existence on 
the date of enactment of the Health Research Extension Act of 
1985 shall terminate upon the appointment of a successor Board 
under subsection (a). The Secretary shall make appointments to 
the Advisory Board established under subsection (a) before the 
expiration of 90 days after such date. The members of the Board 
in existence on such date may be appointed, in accordance with 
subsections (b) and (d), to the Advisory Board established 
under subsection (a).

               JUVENILE ARTHRITIS AND RELATED CONDITIONS

    Sec. 442A. [285d-8] (a) Expansion and Coordination of 
Activities.--The Director of the Institute, in coordination 
with the Director of the National Institute of Allergy and 
Infectious Diseases, shall expand and intensify the programs of 
such Institutes with respect to research and related activities 
concerning juvenile arthritis and related conditions.
    (b) Coordination.--The Directors referred to in subsection 
(a) shall jointly coordinate the programs referred to in such 
subsection and consult with the Arthritis and Musculoskeletal 
Diseases Interagency Coordinating Committee.

                 Subpart 5--National Institute on Aging

                        PURPOSE OF THE INSTITUTE

    Sec. 443. [285e] The general purpose of the National 
Institute on Aging (hereafter in this subpart referred to as 
the ``Institute'') is the conduct and support of biomedical, 
social, and behavioral research, training, health information 
dissemination, and other programs with respect to the aging 
process and the diseases and other special problems and needs 
of the aged.

                           SPECIAL FUNCTIONS

    Sec. 444. [285e-1] (a) In carrying out the training 
responsibilities under this Act or any other Act for health and 
allied health professions personnel, the Secretary shall take 
appropriate steps to insure the education and training of 
adequate numbers of allied health, nursing, and paramedical 
personnel in the field of health care for the aged.
    (b) The Director of the Institute shall conduct scientific 
studies to measure the impact on the biological, medical, 
social, and psychological aspects of aging of programs and 
activities assisted or conducted by the Department of Health 
and Human Services.
    (c) The Director of the Institute shall carry out public 
information and education programs designed to disseminate as 
widely as possible the findings of research sponsored by the 
Institute, other relevant aging research and studies, and other 
information about the process of aging which may assist elderly 
and near-elderly persons in dealing with, and all Americans in 
understanding, the problems and processes associated with 
growing older.
    (d) The Director of the Institute shall make grants to 
public and private nonprofit institutions to conduct research 
relating to Alzheimer's Disease.

                      ALZHEIMER'S DISEASE CENTERS

    Sec. 445. [285e-2] (a)(1) The Director of the Institute may 
enter into cooperative agreements with and make grants to 
public or private nonprofit entities (including university 
medical centers) to pay all or part of the cost of planning, 
establishing, or strengthening, and providing basic operating 
support (including staffing) for centers for basic and clinical 
research (including multidisciplinary research) into, training 
in, and demonstration of advanced diagnostic, prevention, and 
treatment methods for Alzheimer's disease.
    (2) A cooperative agreement or grant under paragraph (1) 
shall be entered into in accordance with policies established 
by the Director of NIH and after consultation with the 
Institute's advisory council.
    (b)(1) Federal payments made under a cooperative agreement 
or grant under subsection (a) may, with respect to Alzheimer's 
disease, be used for--
            (A) diagnostic examinations, patient assessments, 
        patient care costs, and other costs necessary for 
        conducting research;
            (B)  training,  including  training  for  allied  
        health professionals;
            (C) diagnostic and treatment clinics designed to 
        meet the special needs of minority and rural 
        populations and other underserved populations;
            (D) activities to educate the public; and
            (E) the dissemination of information.
    (2) For purposes of paragraph (1), the term ``training'' 
does not include research training for which National Research 
Service Awards \1\ may be provided under section 487.
---------------------------------------------------------------------------
    \1\ Now Ruth L. Kirschstein National Research Service Awards. See 
section 487.
---------------------------------------------------------------------------
    (c) Support of a center under subsection (a) may be for a 
period of not to exceed five years. Such period may be extended 
by the Director for additional periods of not more than five 
years each if the operations of such center have been reviewed 
by an appropriate technical and scientific peer review group 
established by the Director and if such group has recommended 
to the Director that such period should be extended.

         CLAUDE D. PEPPER OLDER AMERICANS INDEPENDENCE CENTERS

    Sec. 445A. [285e-3] (a) The Director of the Institute shall 
enter into cooperative agreements with, and make grants to, 
public and private nonprofit entities for the development or 
expansion of not less than 10 centers of excellence in 
geriatric research and training of researchers. Each such 
center shall be known as a Claude D. Pepper Older Americans 
Independence Center.
    (b) Each center developed or expanded under this section 
shall--
            (1) utilize the facilities of a single institution, 
        or be formed from a consortium of cooperating 
        institutions, meeting such research and training 
        qualifications as may be prescribed by the Director; 
        and
            (2) conduct--
                    (A) research into the aging processes and 
                into the diagnosis and treatment of diseases, 
                disorders, and complications related to aging, 
                including menopause, which research includes 
                research on such treatments, and on medical 
                devices and other medical interventions 
                regarding such diseases, disorders, and 
                complications, that can assist individuals in 
                avoiding institutionalization and prolonged 
                hospitalization and in otherwise increasing the 
                independence of the individuals; and
                    (B) programs to develop individuals capable 
                of conducting research described in 
                subparagraph (A).
    (c) In making cooperative agreements and grants under this 
section for the development or expansion of centers, the 
Director of the Institute shall ensure that, to the extent 
practicable, any such centers are distributed equitably among 
the principal geographic regions of the United States.
    (d) For purposes of this section, the term 
``independence'', with respect to diseases, disorders, and 
complications of aging, means the functional ability of 
individuals to perform activities of daily living or 
instrumental activities of daily living without assistance or 
supervision.
                           awards authorized
    Sec. 445B. \1\ [285e-4] (a) The Director of the Institute 
shall make awards to senior researchers who have made 
distinguished achievements in biomedical research in areas 
relating to Alzheimer's disease and related dementias. Awards 
under this section shall be used by the recipients to support 
research in areas relating to such disease and dementias, and 
may be used by the recipients to train junior researchers who 
demonstrate exceptional promise to conduct research in such 
areas.
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    \1\ Sections 445B through 445F were originally enacted as 
provisions of title IX of Public Law 99-660, and were transferred to 
the Public Health Service Act by section 142 of Public Law 100-607. 
(Various provisions relating to Alzheimer's disease remain in such 
title IX, which is included in this compilation.)
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    (b) The Director of the Institute may make awards under 
this section to researchers at centers supported under section 
445 and to researchers at other public and nonprofit private 
entities.
    (c) The Director of the Institute shall make awards under 
this section only to researchers who have been recommended for 
such awards by the National Advisory Council on Aging.
    (d) The Director of the Institute shall establish 
procedures for the selection of the recipients of awards under 
this section.
    (e) Awards under this section shall be made for a one-year 
period, and may be renewed for not more than six additional 
consecutive one-year periods.
                       research program and plan
    Sec. 445C. [285e-5] (a) The Director of the Institute shall 
conduct, or make grants for the conduct of, research relevant 
to appropriate services for individuals with Alzheimer's 
disease and related dementias and their families.
    (b)(1) Within 6 months after the date of enactment of the 
Alzheimer's Disease and Related Dementias Services Research Act 
of 1986, the Director of the Institute shall prepare and 
transmit to the Chairman of the Council on Alzheimer's Disease 
(in this section referred to as the ``Council'') a plan for the 
research to be conducted under subsection (a). The plan shall--
            (A) provide for research concerning--
                    (i) the epidemiology of, and the 
                identification of risk factors for, Alzheimer's 
                disease and related dementias; and
                    (ii) the development and evaluation of 
                reliable and valid multidimensional diagnostic 
                and assessment procedures and instruments; and
            (B) ensure that research carried out under the plan 
        is coordinated with, and uses, to the maximum extent 
        feasible, resources of, other Federal programs relating 
        to Alzheimer's disease and related dementias, including 
        centers supported under section 445, centers supported 
        by the National Institute of Mental Health on the 
        psychopathology of the elderly, relevant activities of 
        the Administration on Aging, other programs and centers 
        involved in research on Alzheimer's disease and related 
        dementias supported by the Department, and other 
        programs relating to Alzheimer's disease and related 
        dementias which are planned or conducted by Federal 
        agencies other than the Department, State or local 
        agencies, community organizations, or private 
        foundations.
    (2) Within one year after transmitting the plan required 
under paragraph (1), and annually thereafter, the Director of 
the Institute shall prepare and transmit to the Chairman of the 
Council such revisions of such plan as the Director considers 
appropriate.
    (c) In preparing and revising the plan required by 
subsection (b), the Director of the Institute shall consult 
with the Chairman of the Council and the heads of agencies 
within the Department.
    (d) the \1\ Director of the Institute may develop, or make 
grants to develop--
---------------------------------------------------------------------------
    \1\ So in law. See section 9 of Public Law 102-507 (106 Stat. 
3287). Probably should be ``The''.
---------------------------------------------------------------------------
            (1) model techniques to--
                    (A) promote greater independence, including 
                enhanced independence in performing activities 
                of daily living and instrumental activities of 
                daily living, for persons with Alzheimer's 
                disease and related disorders; and
                    (B) prevent or reduce the severity of 
                secondary disabilities, including confusional 
                episodes, falls, bladder and bowel 
                incontinence, and adverse effects of 
                prescription and over-the-counter medications, 
                in such persons; and
            (2) model curricula for health care professionals, 
        health care paraprofessionals, and family caregivers, 
        for training and application in the use of such 
        techniques.
    (e) For purposes of this section, the term ``Council on 
Alzheimer's Disease'' means the council established in section 
911(a) \2\ of Public Law 99-660.
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    \2\ Section 911 was repealed by section 601(a)(2)(E) of Public Law 
105-362 (112 Stat. 3286).
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                             dissemination
    Sec. 445D. [285e-6] The Director of the Institute shall 
disseminate the results of research conducted under section 
445C and this section to appropriate professional entities and 
to the public.
                  clearinghouse on alzheimer's disease
    Sec. 445E. [285e-7] (a) The Director of the Institute shall 
establish the Clearinghouse on Alzheimer's Disease (hereinafter 
referred to as the ``Clearinghouse''). The purpose of the 
Clearinghouse is the dissemination of information concerning 
services available for individuals with Alzheimer's disease and 
related dementias and their families. The Clearinghouse shall--
            (1) compile, archive, and disseminate information 
        concerning research, demonstration, evaluation, and 
        training programs and projects concerning Alzheimer's 
        disease and related dementias; and
            (2) annually publish a summary of the information 
        compiled under paragraph (1) during the preceding 12-
        month period, and make such information available upon 
        request to appropriate individuals and entities, 
        including educational institutions, research entities, 
        and Federal and public agencies.
    (b) The Clearinghouse may charge an appropriate fee for 
information provided through the toll-free telephone line 
established under subsection (a)(3). \1\
---------------------------------------------------------------------------
    \1\ So in law. Section 445E does not contain a subsection (a)(3). 
Section 445F(b)(2) provides for a toll-free telephone line.
---------------------------------------------------------------------------
    (c) The Director of the Institute, the Director of the 
National Institute of Mental Health, and the Director of the 
National Center for Health Services Research and Health Care 
Technology Assessment shall provide to the Clearinghouse 
summaries of the findings of research conducted under part D.
                         dissemination project
    Sec. 445F. [285e-8] (a) The Director of the Institute shall 
make a grant to, or enter into a contract with, a national 
organization representing individuals with Alzheimer's disease 
and related dementias for the conduct of the activities 
described in subsection (b).
    (b) The organization receiving a grant or contract under 
this section shall--
            (1) establish a central computerized information 
        system to--
                    (A) compile and disseminate information 
                concerning initiatives by State and local 
                governments and private entities to provide 
                programs and services for individuals with 
                Alzheimer's disease and related dementias; and
                    (B) translate scientific and technical 
                information concerning such initiatives into 
                information readily understandable by the 
                general public, and make such information 
                available upon request; and
            (2) establish a national toll-free telephone line 
        to make available the information described in 
        paragraph (1), and information concerning Federal 
        programs, services and benefits for individuals with 
        Alzheimer's disease and related dementias and their 
        families.
    (c) The organization receiving a grant or contract under 
this section may charge appropriate fees for information 
provided through the toll-free telephone line established under 
subsection (b)(2), and may make exceptions to such fees for 
individuals and organizations who are not financially able to 
pay such fees.
    (d) In order to receive a grant or contract under this 
section, an organization shall submit an application to the 
Director of the Institute. Such application shall contain--
            (1) information demonstrating that such 
        organization has a network of contacts which will 
        enable such organization to receive information 
        necessary to the operation of the central computerized 
        information system described in subsection (b)(1);
            (2) information demonstrating that, by the end of 
        fiscal year 1991, such organization will be financially 
        able to, and will, carry out the activities described 
        in subsection (b) without a grant or contract from the 
        Federal Government; and
            (3) such other information as the Director may 
        prescribe.
              h3  deg.alzheimer's disease registry
    Sec. 445G. [285e-9] (a) In General.--The Director of the 
Institute may make a grant to develop a registry for the 
collection of epidemiological data about Alzheimer's disease 
and its incidence in the United States, to train personnel in 
the collection of such data, and for other matters respecting 
such disease.
    (b) Qualifications.--To qualify for a grant under 
subsection (a) an applicant shall--
            (1) be an accredited school of medicine or public 
        health which has expertise in the collection of 
        epidemiological data about individuals with Alzheimer's 
        disease and in the development of disease registries, 
        and
            (2) have access to a large patient population, 
        including a patient population representative of 
        diverse ethnic backgrounds.
                    aging processes regarding women
    Sec. 445H. [285e-10] The Director of the Institute, in 
addition to other special functions specified in section 444 
and in cooperation with the Directors of the other national 
research institutes and agencies of the National Institutes of 
Health, shall conduct research into the aging processes of 
women, with particular emphasis given to the effects of 
menopause and the physiological and behavioral changes 
occurring during the transition from pre- to post-menopause, 
and into the diagnosis, disorders, and complications related to 
aging and loss of ovarian hormones in women.

SEC. 445I. [285E-10A] ALZHEIMER'S CLINICAL RESEARCH AND TRAINING 
                    AWARDS.

    (a) In General.--The Director of the Institute is 
authorized to establish and maintain a program to enhance and 
promote the translation of new scientific knowledge into 
clinical practice related to the diagnosis, care and treatment 
of individuals with Alzheimer's disease.
    (b) Support of Promising Clinicians.--In order to foster 
the application of the most current developments in the 
etiology, pathogenesis, diagnosis, prevention and treatment of 
Alzheimer's disease, amounts made available under this section 
shall be directed to the support of promising clinicians 
through awards for research, study, and practice at centers of 
excellence in Alzheimer's disease research and treatment.
    (c) Excellence in Certain Fields.--Research shall be 
carried out under awards made under subsection (b) in 
environments of demonstrated excellence in neuroscience, 
neurobiology, geriatric medicine, and psychiatry and shall 
foster innovation and integration of such disciplines or other 
environments determined suitable by the Director of the 
Institute.

    Subpart 6--National Institute of Allergy and Infectious Diseases

                        purpose of the institute
    Sec. 446. [285f] The general purpose of the National 
Institute of Allergy and Infectious Diseases is the conduct and 
support of research, training, health information 
dissemination, and other programs with respect to allergic and 
immunologic diseases and disorders and infectious diseases, 
including tropical diseases.
          research centers regarding chronic fatigue syndrome
    Sec. 447. [285f-1] (a) The Director of the Institute, after 
consultation with the advisory council for the Institute, may 
make grants to, or enter into contracts with, public or 
nonprofit private entities for the development and operation of 
centers to conduct basic and clinical research on chronic 
fatigue syndrome.
    (b) Each center assisted under this section shall use the 
facilities of a single institution, or be formed from a 
consortium of cooperating institutions, meeting such 
requirements as may be prescribed by the Director of the 
Institute.
         research and research training regarding tuberculosis
    Sec. 447A. [285f-2] In carrying out section 446, the 
Director of the Institute shall conduct or support research and 
research training regarding the cause, diagnosis, early 
detection, prevention and treatment of tuberculosis.

SEC. 447B. [285F-3] SEXUALLY TRANSMITTED DISEASE CLINICAL RESEARCH AND 
                    TRAINING AWARDS.

    (a) In General.--The Director of the Institute is 
authorized to establish and maintain a program to enhance and 
promote the translation of new scientific knowledge into 
clinical practice related to the diagnosis, care and treatment 
of individuals with sexually transmitted diseases.
    (b) Support of Promising Clinicians.--In order to foster 
the application of the most current developments in the 
etiology, pathogenesis, diagnosis, prevention and treatment of 
sexually transmitted diseases, amounts made available under 
this section shall be directed to the support of promising 
clinicians through awards for research, study, and practice at 
centers of excellence in sexually transmitted disease research 
and treatment.
    (c) Excellence in Certain Fields.--Research shall be 
carried out under awards made under subsection (b) in 
environments of demonstrated excellence in the etiology and 
pathogenesis of sexually transmitted diseases and shall foster 
innovation and integration of such disciplines or other 
environments determined suitable by the Director of the 
Institute.

SEC. 447C. [285F-4] MICROBICIDE RESEARCH AND DEVELOPMENT.

    The Director of the Institute, acting through the head of 
the Division of AIDS, shall, consistent with the peer-review 
process of the National Institutes of Health, carry out 
research on, and development of, safe and effective methods for 
use by women to prevent the transmission of the human 
immunodeficiency virus, which may include microbicides.

 Subpart 7--Eunice Kennedy Shriver National Institute of Child Health 
                       and Human Development \1\
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    \1\ Section 1004 of Public Law 106-310 (114 Stat. 1130) authorizes 
the Director of the Institute to conduct a national longitudinal study 
of environmental influences (including physical, chemical, biological, 
and psychosocial) on children's health and development. Subsection (d) 
of such section requires periodic reports to the Congress regarding the 
study. The first report is required to be submitted not later than 
three years after the date of the enactment of the Public Law, which 
was enacted October 17, 2000.
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                        purpose of the institute
    Sec. 448. [285g] The general purpose of the National 
Institute of Child Health and Human Development \1\ (hereafter 
in this subpart referred to as the ``Institute'') is the 
conduct and support of research, training, health information 
dissemination, and other programs with respect to gynecologic 
health, maternal health, child health, mental retardation, 
human growth and development, including prenatal development, 
population research, and special health problems and 
requirements of mothers and children.
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    \1\ The probable intent of the Congress is to refer to the ``Eunice 
Kennedy Shriver National Institute of Child Health and Human 
Development''. Section 1(b)(7) of Public Law 110-154 (121 Stat 1827) 
struck the term ``National Institute of Child Health and Human 
Development'' and inserted ``Eunice Kennedy Shriver National Institute 
of Child Health and Human Development'' each place such term appeared 
in the heading of subpart 7 of part C of title IV, but not in the text 
of section 448.
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                      sudden infant death syndrome
    Sec. 449. [285g-1] The Director of the Institute shall 
conduct and support research which specifically relates to 
sudden infant death syndrome.
                      mental retardation research
    Sec. 450. [285g-2] The Director of the Institute shall 
conduct and support research and related activities into the 
causes, prevention, and treatment of mental retardation.
                   associate director for prevention
    Sec. 451. [285g-3] There shall be in the Institute an 
Associate Director for Prevention to coordinate and promote the 
programs in the Institute concerning the prevention of health 
problems of mothers and children. The Associate Director shall 
be appointed by the Director of the Institute from individuals 
who because of their professional training or experience are 
experts in public health or preventive medicine.
          national center for medical rehabilitation research
    Sec. 452. [285g-4] (a) There shall be in the Institute an 
agency to be known as the National Center for Medical 
Rehabilitation Research (hereafter in this section referred to 
as the ``Center'') \1\. The Director of the Institute shall 
appoint a qualified individual to serve as Director of the 
Center. The Director of the Center shall report directly to the 
Director of the Institute.
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    \1\ Section 3(b) of Public Law 101-613 requires that Federal 
agencies, as appropriate, enter into agreements for preventing 
duplication among Federal programs regarding medical rehabilitation. 
Such section requires that the agreements be made not later than one 
year after the date of the enactment of the Public Law, which was 
enacted November 16, 1990.
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    (b) The general purpose of the Center is the conduct and 
support of research and research training (including research 
on the development of orthotic and prosthetic devices), the 
dissemination of health information, and other programs with 
respect to the rehabilitation of individuals with physical 
disabilities resulting from diseases or disorders of the 
neurological, musculoskeletal, cardiovascular, pulmonary, or 
any other physiological system (hereafter in this section 
referred to as ``medical rehabilitation'').
    (c)(1) In carrying out the purpose described in subsection 
(b), the Director of the Center may--
            (A) provide for clinical trials regarding medical 
        rehabilitation;
            (B) provide for research regarding model systems of 
        medical rehabilitation;
            (C) coordinate the activities of the Center with 
        similar activities of other agencies of the Federal 
        Government, including the other agencies of the 
        National Institutes of Health, and with similar 
        activities of other public entities and of private 
        entities;
            (D) support multidisciplinary medical 
        rehabilitation research conducted or supported by more 
        than one such agency;
            (E) in consultation with the advisory council for 
        the Institute and with the approval of the Director of 
        NIH--
                    (i) establish technical and scientific peer 
                review groups in addition to those appointed 
                under section 402(b)(16); and
                    (ii) appoint the members of peer review 
                groups established under subparagraph (A); and
            (F) support medical rehabilitation research and 
        training centers.
The Federal Advisory Committee Act shall not apply to the 
duration of a peer review group appointed under subparagraph 
(E).
    (2) In carrying out this section, the Director of the 
Center may make grants and enter into cooperative agreements 
and contracts.
    (d)(1) In consultation with the Director of the Center, the 
coordinating committee established under subsection (e), and 
the advisory board established under subsection (f), the 
Director of the Institute shall develop a comprehensive plan 
for the conduct and support of medical rehabilitation research 
(hereafter in this section referred to as the ``Research 
Plan'').
    (2) The Research Plan shall--
            (A) identify current medical rehabilitation 
        research activities conducted or supported by the 
        Federal Government, opportunities and needs for 
        additional research, and priorities for such research; 
        and
            (B) make recommendations for the coordination of 
        such research conducted or supported by the National 
        Institutes of Health and other agencies of the Federal 
        Government.
    (3)(A) Not later than 18 months after the date of the 
enactment of the National Institutes of Health Revitalization 
Amendments of 1990, \1\ the Director of the Institute shall 
transmit the Research Plan to the Director of NIH, who shall 
submit the Plan to the President and the Congress.
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    \1\ So in law. No Act with such a short title was enacted during 
1990. The probable intent of the Congress was to make a reference to 
Public Law 101-613, the National Institutes of Health Amendments of 
1990, which added section 452 and which was enacted November 16, 1990.
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    (B) Subparagraph (A) shall be carried out independently of 
the process of reporting that is required in sections 403 and 
407.
    (4) The Director of the Institute shall periodically revise 
and update the Research Plan as appropriate, after consultation 
with the Director of the Center, the coordinating committee 
established under subsection (e), and the advisory board 
established under subsection (f). A description of any 
revisions in the Research Plan shall be contained in each 
report prepared under section 407 by the Director of the 
Institute.
    (e)(1) The Director of NIH shall establish a committee to 
be known as the Medical Rehabilitation Coordinating Committee 
(hereafter in this section referred to as the ``Coordinating 
Committee'').
    (2) The Coordinating Committee shall make recommendations 
to the Director of the Institute and the Director of the Center 
with respect to the content of the Research Plan and with 
respect to the activities of the Center that are carried out in 
conjunction with other agencies of the National Institutes of 
Health and with other agencies of the Federal Government.
    (3) The Coordinating Committee shall be composed of the 
Director of the Center, the Director of the Institute, and the 
Directors of the National Institute on Aging, the National 
Institute of Arthritis and Musculoskeletal and Skin Diseases, 
the National Heart, Lung, and Blood Institute, the National 
Institute of Neurological Disorders and Stroke, and such other 
national research institutes and such representatives of other 
agencies of the Federal Government as the Director of NIH 
determines to be appropriate.
    (4) The Coordinating Committee shall be chaired by the 
Director of the Center.
    (f)(1) Not later than 90 days after the date of the 
enactment of the National Institutes of Health Revitalization 
Amendments of 1990, \1\ the Director of NIH shall establish a 
National Advisory Board on Medical Rehabilitation Research 
(hereafter in this section referred to as the ``Advisory 
Board'').
---------------------------------------------------------------------------
    \1\ See footnote for subsection (d)(3)(A).
---------------------------------------------------------------------------
    (2) The Advisory Board shall review and assess Federal 
research priorities, activities, and findings regarding medical 
rehabilitation research, and shall advise the Director of the 
Center and the Director of the Institute on the provisions of 
the Research Plan.
    (3)(A) The Director of NIH shall appoint to the Advisory 
Board 18 qualified representatives of the public who are not 
officers or employees of the Federal Government. Of such 
members, 12 shall be representatives of health and scientific 
disciplines with respect to medical rehabilitation and 6 shall 
be individuals representing the interests  of  individuals  
undergoing,  or  in  need  of,  medical rehabilitation.
    (B) The following officials shall serve as ex officio 
members of the Advisory Board:
            (i) The Director of the Center.
            (ii) The Director of the Institute.
            (iii) The Director of the National Institute on 
        Aging.
            (iv) The Director of the National Institute of 
        Arthritis and Musculoskeletal and Skin Diseases.
            (v) The Director of the National Institute on 
        Deafness and Other Communication Disorders.
            (vi) The Director of the National Heart, Lung, and 
        Blood Institute.
            (vii) The Director of the National Institute of 
        Neurological Disorders and Stroke.
            (viii) The Director of the National Institute on 
        Disability and Rehabilitation Research.
            (ix) The Commissioner for Rehabilitation Services 
        Administration.
            (x) The Assistant Secretary of Defense (Health 
        Affairs).
            (xi) The Chief Medical Director of the Department 
        of Veterans Affairs.
    (4) The members of the Advisory Board shall, from among the 
members appointed under paragraph (3)(A), designate an 
individual to serve as the chair of the Advisory Board.
  h3  deg.research centers with respect to contraception and 
                              infertility
    Sec. 452A. [285g-5] (a) The Director of the Institute, 
after consultation with the advisory council for the Institute, 
shall make grants to, or enter into contracts with, public or 
nonprofit private entities for the development and operation of 
centers to conduct activities for the purpose of improving 
methods of contraception and centers to conduct activities for 
the purpose of improving methods of diagnosis and treatment of 
infertility.
    (b) In carrying out subsection (a), the Director of the 
Institute shall, subject to the extent of amounts made 
available in appropriations Acts, provide for the establishment 
of three centers with respect to contraception and for two 
centers with respect to infertility.
    (c)(1) Each center assisted under this section shall, in 
carrying out the purpose of the center involved--
            (A) conduct clinical and other applied research, 
        including--
                    (i) for centers with respect to 
                contraception, clinical trials of new or 
                improved drugs and devices for use by males and 
                females (including barrier methods); and
                    (ii) for centers with respect to 
                infertility, clinical trials of new or improved 
                drugs and devices for the diagnosis and 
                treatment of infertility in males and females;
            (B) develop protocols for training physicians, 
        scientists, nurses, and other health and allied health 
        professionals;
            (C) conduct training programs for such individuals;
            (D) develop model continuing education programs for 
        such professionals; and
            (E) disseminate information to such professionals 
        and the public.
    (2) A center may use funds provided under subsection (a) to 
provide stipends for health and allied health professionals 
enrolled in programs described in subparagraph (C) of paragraph 
(1), and to provide fees to individuals serving as subjects in 
clinical trials conducted under such paragraph.
    (d) The Director of the Institute shall, as appropriate, 
provide for the coordination of information among the centers 
assisted under this section.
    (e) Each center assisted under subsection (a) shall use the 
facilities of a single institution, or be formed from a 
consortium of cooperating institutions, meeting such 
requirements as may be prescribed by the Director of the 
Institute.
    (f) Support of a center under subsection (a) may be for a 
period not exceeding 5 years. Such period may be extended for 
one or more additional periods not exceeding 5 years if the 
operations of such center have been reviewed by an appropriate 
technical and scientific peer review group established by the 
Director and if such group has recommended to the Director that 
such period should be extended.
      h3  deg.program regarding obstetrics and gynecology
    Sec. 452B. [285g-6] The Director of the Institute shall 
establish and maintain within the Institute an intramural 
laboratory and clinical research program in obstetrics and 
gynecology.
             h3  deg.child health research centers
    Sec. 452C. [285g-7] The Director of the Institute shall 
develop and support centers for conducting research with 
respect to child health. Such centers shall give priority to 
the expeditious transfer of advances from basic science to 
clinical applications and improving the care of infants and 
children.
          prospective longitudinal study on adolescent health
    Sec. 452D. [285g-8] (a) In General.--Not later than October 
1, 1993, the Director of the Institute shall commence a study 
for the purpose of providing information on the general health 
and well-being of adolescents in the United States, including, 
with respect to such adolescents, information on--
            (1) the behaviors that promote health and the 
        behaviors that are detrimental to health; and
            (2) the influence on health of factors particular 
        to the communities in which the adolescents reside.
    (b) Design of Study.--
            (1) In general.--The study required in subsection 
        (a) shall be a longitudinal study in which a 
        substantial number of adolescents participate as 
        subjects. With respect to the purpose described in such 
        subsection, the study shall monitor the subjects 
        throughout the period of the study to determine the 
        health status of the subjects and any change in such 
        status over time.
            (2) Population-specific analyses.--The study 
        required in subsection (a) shall be conducted with 
        respect to the population of adolescents who are 
        female, the population of adolescents who are male, 
        various socioeconomic populations of adolescents, and 
        various racial and ethnic populations of adolescents. 
        The study shall be designed and conducted in a manner 
        sufficient to provide for a valid analysis of whether 
        there are significant differences among such 
        populations in health status and whether and to what 
        extent any such differences are due to factors 
        particular to the populations involved.
    (c) Coordination With Women's Health Initiative.--With 
respect to the national study of women being conducted by the 
Secretary and known as the Women's Health Initiative, the 
Secretary shall ensure that such study is coordinated with the 
component of the study required in subsection (a) that concerns 
adolescent females, including coordination in the design of the 
2 studies.
                               fragile x
    Sec. 452E. [285g-9] (a) Expansion and Coordination of 
Research Activities.--The Director of the Institute, after 
consultation with the advisory council for the Institute, shall 
expand, intensify, and coordinate the activities of the 
Institute with respect to research on the disease known as 
fragile X.
    (b) Research Centers.--
            (1) In general.--The Director of the Institute 
        shall make grants or enter into contracts for the 
        development and operation of centers to conduct 
        research for the purposes of improving the diagnosis 
        and treatment of, and finding the cure for, fragile X.
            (2) Number of centers.--
                    (A) In general.--In carrying out paragraph 
                (1), the Director of the Institute shall, to 
                the extent that amounts are appropriated, and 
                subject to subparagraph (B), provide for the 
                establishment of at least three fragile X 
                research centers.
                    (B) Peer review requirement.--The Director 
                of the Institute shall make a grant to, or 
                enter into a contract with, an entity for 
                purposes of establishing a center under 
                paragraph (1) only if the grant or contract has 
                been recommended after technical and scientific 
                peer review required by regulations under 
                section 492.
            (3) Activities.--The Director of the Institute, 
        with the assistance of centers established under 
        paragraph (1), shall conduct and support basic and 
        biomedical research into the detection and treatment of 
        fragile X.
            (4) Coordination among centers.--The Director of 
        the Institute shall, as appropriate, provide for the 
        coordination of the activities of the centers assisted 
        under this section, including providing for the 
        exchange of information among the centers.
            (5) Certain administrative requirements.--Each 
        center assisted under paragraph (1) shall use the 
        facilities of a single institution, or be formed from a 
        consortium of cooperating institutions, meeting such 
        requirements as may be prescribed by the Director of 
        the Institute.
            (6) Duration of support.--Support may be provided 
        to a center under paragraph (1) for a period not 
        exceeding 5 years. Such period may be extended for one 
        or more additional periods, each of which may not 
        exceed 5 years, if the operations of such center have 
        been reviewed by an appropriate technical and 
        scientific peer review group established by the 
        Director and if such group has recommended to the 
        Director that such period be extended.
             investment in tomorrow's pediatric researchers
    Sec. 452G. \1\ [285g-10] In order to ensure the future 
supply of researchers dedicated to the care and research needs 
of children, the Director of the Institute, after consultation 
with the Administrator of the Health Resources and Services 
Administration, shall support activities to provide for--
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    \1\So in law. Probably should be ``Sec. 452F.''. See amendments 
made by sections 201 and 1002 of Public Law 106-310 (114 Stat. 1109, 
1128). (In amending this subpart to add section 452G above, such 
section 1002 made a reference to this subpart ``as amended by section 
921'' of Public Law 106-310, but no section 921 appeared in the Public 
Law.)
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            (1) an increase in the number and size of 
        institutional training grants to institutions 
        supporting pediatric training; and
            (2) an increase in the number of career development 
        awards for health professionals who intend to build 
        careers in pediatric basic and clinical research, 
        including pediatric pharmacological research.

          Subpart 8--National Institute of Dental Research \1\

                        purpose of the institute
    Sec. 453. [285h] The general purpose of the National 
Institute of Dental Research \1\ is the conduct and support of 
research, training, health information dissemination, and other 
programs with respect to the cause, prevention, and methods of 
diagnosis and treatment of dental and oral diseases and 
conditions.
---------------------------------------------------------------------------
    \1\See footnote for section 401(b)(1)(H).
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                   Subpart 9--National Eye Institute

                        purpose of the institute
    Sec. 455. [285i] The general purpose of the National Eye 
Institute (hereafter in this subpart referred to as the 
``Institute'') is the conduct and support of research, 
training, health information dissemination, and other programs 
with respect to blinding eye diseases, visual disorders, 
mechanisms of visual function, preservation of sight, and the 
special health problems and requirements of the blind. Subject 
to section 456, the Director of the Institute may carry out a 
program of grants for public and private nonprofit vision 
research facilities.
               clinical research on eye care and diabetes
    Sec. 456. [285i-1] (a) Program of Grants.--The Director of 
the Institute, in consultation with the advisory council for 
the Institute, may award research grants to one or more 
Diabetes Eye Research Institutions for the support of programs 
in clinical or health services aimed at--
            (1) providing comprehensive eye care services for 
        people with diabetes, including a full complement of 
        preventive, diagnostic and treatment procedures;
            (2) developing new and improved techniques of 
        patient care through basic and clinical research;
            (3) assisting in translation of the latest research 
        advances into clinical practice; and
            (4) expanding the knowledge of the eye and diabetes 
        through further research.
    (b) Use of Funds.--Amounts received under a grant awarded 
under this section shall be used for the following:
            (1) Establishing the biochemical, cellular, and 
        genetic mechanisms associated with diabetic eye disease 
        and the earlier detection of pending eye abnormalities. 
        The focus of work under this paragraph shall require 
        that ophthalmologists have training in the most up-to-
        date molecular and cell biological methods.
            (2) Establishing new frontiers in technology, such 
        as video-based diagnostic and research resources, to--
                    (A) provide improved patient care;
                    (B) provide for the evaluation of retinal 
                physiology and its affect on diabetes; and
                    (C) provide for the assessment of risks for 
                the development and progression of diabetic eye 
                disease and a more immediate evaluation of 
                various therapies aimed at preventing diabetic 
                eye disease.
        Such technologies shall be designed to permit 
        evaluations to be performed both in humans and in 
        animal models.
            (3) The translation of the results of vision 
        research into the improved care of patients with 
        diabetic eye disease. Such translation shall require 
        the application of institutional resources that 
        encompass patient care, clinical research and basic 
        laboratory research.
            (4) The conduct of research concerning the outcomes 
        of eye care treatments and eye health education 
        programs as they relate to patients with diabetic eye 
        disease, including the evaluation of regional 
        approaches to such research.
    (c) Authorized Expenditures.--The purposes for which a 
grant under subsection (a) may be expended include equipment 
for the research described in such subsection.

  Subpart 10--National Institute of Neurological Disorders and Stroke

                        purpose of the institute
    Sec. 457. [285j] The general purpose of the National 
Institute of Neurological Disorders and Stroke (hereafter in 
this subpart referred to as the ``Institute'') is the conduct 
and support of research, training, health information 
dissemination, and other programs with respect to neurological 
disease and disorder and stroke.
                   spinal cord regeneration research
    Sec. 458. [285j-1] The Director of the Institute shall 
conduct and support research into spinal cord regeneration.
                        bioengineering research
    Sec. 459. [285j-2] The Director of the Institute shall make 
grants or enter into contracts for research on the means to 
overcome paralysis of the extremities through electrical 
stimulation and the use of computers.
             h3  deg.research on multiple sclerosis
    Sec. 460. [285j-3] The Director of the Institute shall 
conduct and support research on multiple sclerosis, especially 
research on effects of genetics and hormonal changes on the 
progress of the disease.

       Subpart 11--National Institute of General Medical Sciences

                        purpose of the institute
    Sec. 461. [285k] The general purpose of the National 
Institute of General Medical Sciences is the conduct and 
support of research, training, and, as appropriate, health 
information dissemination, and other programs with respect to 
general or basic medical sciences and related natural or 
behavioral sciences which have significance for two or more 
other national research institutes or are outside the general 
area of responsibility of any other national research 
institute.

    Subpart 12--National Institute of Environmental Health Sciences

                        purpose of the institute
    Sec. 463. [285l] The general purpose of the National 
Institute of Environmental Health Sciences (in this subpart 
referred to as the ``Institute'') is the conduct and support of 
research, training, health information dissemination, and other 
programs with respect to factors in the environment that affect 
human health, directly or indirectly.
   h3  deg.applied toxicological research and testing program
    Sec. 463A. [285l-1] (a) There is established within the 
Institute a program for conducting applied research and testing 
regarding toxicology, which program shall be known as the 
Applied Toxicological Research and Testing Program.
    (b) In carrying out the program established under 
subsection (a), the Director of the Institute shall, with 
respect to toxicology, carry out activities--
            (1) to expand knowledge of the health effects of 
        environmental agents;
            (2) to broaden the spectrum of toxicology 
        information that is obtained on selected chemicals;
            (3) to develop and validate assays and protocols, 
        including alternative methods that can reduce or 
        eliminate the use of animals in acute or chronic safety 
        testing;
            (4) to establish criteria for the validation and 
        regulatory acceptance of alternative testing and to 
        recommend a process through which scientifically 
        validated alternative methods can be accepted for 
        regulatory use;
            (5) to communicate the results of research to 
        government agencies, to medical, scientific, and 
        regulatory communities, and to the public; and
            (6) to integrate related activities of the 
        Department of Health and Human Services.
      methods of controlling certain insect and vermin populations
    Sec. 463B. [285l-6] The Director of the Institute shall 
conduct or support research to identify or develop methods of 
controlling insect and vermin populations that transmit to 
humans diseases that have significant adverse health 
consequences.

 H2  deg.Subpart 13--National Institute on Deafness and Other 
                        Communication Disorders

                h3  deg.purpose of the institute
    Sec. 464. [285m] The general purpose of the National 
Institute on Deafness and Other Communication Disorders 
(hereafter referred to in this subpart as the ``Institute'') is 
the conduct and support of research and training, the 
dissemination of health information, and other programs with 
respect to disorders of hearing and other communication 
processes, including diseases affecting hearing, balance, 
voice, speech, language, taste, and smell.
  h3  deg.national deafness and other communication disorders 
                                program
    Sec. 464A. [285m-1] (a) The Director of the Institute, with 
the advice of the Institute's advisory council, shall establish 
a National Deafness and Other Communication Disorders Program 
(hereafter in this section referred to as the ``Program''). The 
Director or \1\ the Institute shall, with respect to the 
Program, prepare and transmit to the Director of NIH a plan to 
initiate, expand, intensify and coordinate activities of the 
Institute respecting disorders of hearing (including tinnitus) 
and other communication processes, including diseases affecting 
hearing, balance, voice, speech, language, taste, and smell. 
The plan shall include such comments and recommendations as the 
Director of the Institute determines appropriate. The Director 
of the Institute shall periodically review and revise the plan 
and shall transmit any revisions of the plan to the Director of 
NIH.
---------------------------------------------------------------------------
    \1\ So in law. See section 2(4) of Public Law 100-553 (102 Stat. 
2769). Probably should be ``Director of''.
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    (b) Activities under the Program shall include--
            (1) investigation into the etiology, pathology, 
        detection, treatment, and prevention of all forms of 
        disorders of hearing and other communication processes, 
        primarily through the support of basic research in such 
        areas as anatomy, audiology, biochemistry, 
        bioengineering, epidemiology, genetics, immunology, 
        microbiology, molecular biology, the neurosciences, 
        otolaryngology, psychology, pharmacology, physiology, 
        speech and language pathology, and any other scientific 
        disciplines that can contribute important knowledge to 
        the understanding and elimination of disorders of 
        hearing and other communication processes;
            (2) research into the evaluation of techniques 
        (including surgical, medical, and behavioral 
        approaches) and devices (including hearing aids, 
        implanted auditory and nonauditory prosthetic devices 
        and other communication aids) used in diagnosis, 
        treatment, rehabilitation, and prevention of disorders 
        of hearing and other communication processes;
            (3) research into prevention, and early detection 
        and diagnosis, of hearing loss and speech and language 
        disturbances (including stuttering) and research into 
        preventing the effects of such disorders on learning 
        and learning disabilities with extension of programs 
        for appropriate referral and rehabilitation;
            (4) research into the detection, treatment, and 
        prevention of disorders of hearing and other 
        communication processes in the growing elderly 
        population with extension of rehabilitative programs to 
        ensure continued effective communication skills in such 
        population;
            (5) research to expand knowledge of the effects of 
        environmental agents that influence hearing or other 
        communication processes; and
            (6) developing and facilitating intramural programs 
        on clinical and fundamental aspects of disorders of 
        hearing and all other communication processes.
       h3  deg.data system and information clearinghouse
    Sec. 464B. [285m-2] (a) The Director of the Institute shall 
establish a National Deafness and Other Communication Disorders 
Data System for the collection, storage, analysis, retrieval, 
and dissemination of data derived from patient populations with 
disorders of hearing or other communication processes, 
including where possible, data involving general populations 
for the purpose of identifying individuals at risk of 
developing such disorders.
    (b) The Director of the Institute shall establish a 
National Deafness and Other Communication Disorders Information 
Clearinghouse to facilitate and enhance, through the effective 
dissemination of information, knowledge and understanding of 
disorders of hearing and other communication processes by 
health professionals, patients, industry, and the public.
     h3  deg.multipurpose deafness and other communication 
                            disorders center
    Sec. 464C. [285m-3] (a) The Director of the Institute 
shall, after consultation with the advisory council for the 
Institute, provide for the development, modernization, and 
operation (including care required for research) of new and 
existing centers for studies of disorders of hearing and other 
communication processes. For purposes of this section, the term 
``modernization'' means the alteration, remodeling, 
improvement, expansion, and repair of existing buildings and 
the provision of equipment for such buildings to the extent 
necessary to make them suitable for use as centers described in 
the preceding sentence.
    (b) Each center assisted under this section shall--
            (1) use the facilities of a single institution or a 
        consortium of cooperating institutions; and
            (2) meet such qualifications as may be prescribed 
        by the Secretary.
    (c) Each center assisted under this section shall, at 
least, conduct--
            (1) basic and clinical research into the cause 
        diagnosis, early detection, prevention, control and 
        treatment of disorders of hearing and other 
        communication processes and complications resulting 
        from such disorders, including research into 
        rehabilitative aids, implantable biomaterials, auditory 
        speech processors, speech production devices, and other 
        otolaryngologic procedures;
            (2) training programs for physicians, scientists, 
        and other health and allied health professionals;
            (3) information and continuing education programs 
        for physicians and other health and allied health 
        professionals who will provide care for patients with 
        disorders of hearing or other communication processes; 
        and
            (4) programs for the dissemination to the general 
        public of information--
                    (A) on the importance of early detection of 
                disorders of hearing and other communication 
                processes, of seeking prompt treatment, 
                rehabilitation, and of following an appropriate 
                regimen; and
                    (B) on the importance of avoiding exposure 
                to noise and other environmental toxic agents 
                that may affect disorders of hearing or other 
                communication processes.
    (d) A center may use funds provided under subsection (a) to 
provide stipends for health professionals enrolled in training 
programs described in subsection (c)(2).
    (e) Each center assisted under this section may conduct 
programs--
            (1) to establish the effectiveness of new and 
        improved methods of detection, referral, and diagnosis 
        of individuals at risk of developing disorders of 
        hearing or other communication processes; and
            (2) to disseminate the results of research, 
        screening, and other activities, and develop means of 
        standardizing patient data and recordkeeping.
    (f) The Director of the Institute shall, to the extent 
practicable, provide for an equitable geographical distribution 
of centers assisted under this section. The Director shall give 
appropriate consideration to the need for centers especially 
suited to meeting the needs of the elderly, and of children 
(particularly with respect to their education and training), 
affected by disorders of hearing or other communication 
processes.
    (g) Support of a center under this section may be for a 
period not to exceed seven years. Such period may be extended 
by the Director of the Institute for one or more additional 
periods of not more than five years if the operations of such 
center have been reviewed by an appropriate technical and 
scientific peer review group established by the Director, with 
the advice of the Institute's advisory council, if such group 
has recommended to the Director that such period should be 
extended.
   national institute on deafness and other communication disorders 
                             advisory board
    Sec. 464D. [285m-4] (a) The Secretary shall establish in 
the Institute the National Deafness and Other Communications 
Disorders Advisory Board (hereafter in this section referred to 
as the ``Advisory Board'').
    (b) The Advisory Board shall be composed of eighteen 
appointed members and nonvoting ex officio members as follows:
            (1) The Secretary shall appoint--
                    (A) twelve members from individuals who are 
                scientists, physicians, and other health and 
                rehabilitation professionals, who are not 
                officers or employees of the United States, and 
                who represent the specialties and disciplines 
                relevant to deafness and other communication 
                disorders, including not less than two persons 
                with a communication disorder; and
                    (B) six members from the general public who 
                are knowledgeable with respect to such 
                disorders, including not less than one person 
                with a communication disorder and not less than 
                one person who is a parent of an individual 
                with such a disorder.
        Of the appointed members, not less than five shall by 
        virtue of training or experience be knowledgeable in 
        diagnoses and rehabilitation of communication 
        disorders, education of the hearing, speech, or 
        language impaired, public health, public information, 
        community program development, occupational hazards to 
        communications senses, or the aging process.
            (2) The following shall be ex officio members of 
        each Advisory Board:
                    (A) The Assistant Secretary for Health, the 
                Director of NIH, the Director of the National 
                Institute on Deafness and Other Communication 
                Disorders, the Director of the Centers for 
                Disease Control and Prevention, the Chief 
                Medical Director of the Department of Veterans 
                Affairs, and the Assistant Secretary of Defense 
                for Health Affairs (or the designees of such 
                officers).
                    (B) Such other officers and employees of 
                the United States as the Secretary determines 
                necessary for the Advisory Board to carry out 
                its functions.
    (c) Members of an Advisory Board who are officers or 
employees of the Federal Government shall serve as members of 
the Advisory Board without compensation in addition to that 
received in their regular public employment. Other members of 
the Board shall receive compensation at rates not to exceed the 
daily equivalent of the annual rate in effect for grade GS-18 
of the General Schedule for each day (including traveltime) 
they are engaged in the performance of their duties as members 
of the Board.
    (d) The term of office of an appointed member of the 
Advisory Board is four years, except that no term of office may 
extend beyond the expiration of the Advisory Board. Any member 
appointed to fill a vacancy for an unexpired term shall be 
appointed for the remainder of such term. A member may serve 
after the expiration of the member's term until a successor has 
taken office. If a vacancy occurs in the Advisory Board, the 
Secretary shall make an appointment to fill the vacancy not 
later than 90 days from the date the vacancy occurred.
    (e) The members of the Advisory Board shall select a 
chairman from among the appointed members.
    (f) The Secretary shall, after consultation with and 
consideration of the recommendations of the Advisory Board, 
provide the Advisory Board with an executive director and one 
other professional staff member. In addition, the Secretary 
shall, after consultation with and consideration of the 
recommendations of the Advisory Board, provide the Advisory 
Board with such additional professional staff members, such 
clerical staff members, such services of consultants, such 
information, and (through contracts or other arrangements) such 
administrative support services and facilities, as the 
Secretary determines are necessary for the Advisory Board to 
carry out its functions.
    (g) The Advisory Board shall meet at the call of the 
chairman or upon request of the Director of the Institute, but 
not less often than four times a year.
    (h) The Advisory Board shall--
            (1) review and evaluate the implementation of the 
        plan prepared under section 464A(a) and periodically 
        update the plan to ensure its continuing relevance;
            (2) for the purpose of assuring the most effective 
        use and organization of resources respecting deafness 
        and other communication disorders, advise and make 
        recommendations to the Congress, the Secretary, the 
        Director of NIH, the Director of the Institute, and the 
        heads of other appropriate Federal agencies for the 
        implementation and revision of such plan; and
            (3) maintain liaison with other advisory bodies 
        related to Federal agencies involved in the 
        implementation of such plan and with key non-Federal 
        entities involved in activities affecting the control 
        of such disorders.
    (i) In carrying out its functions, the Advisory Board may 
establish subcommittees, convene workshops and conferences, and 
collect data. Such subcommittees may be composed of Advisory 
Board members and nonmember consultants with expertise in the 
particular area addressed by such subcommittees. The 
subcommittees may hold such meetings as are necessary to enable 
them to carry out their activities.
    (k) \1\ The National Deafness and Other Communication 
Disorders Advisory Board shall be established not later than 
April 1, 1989.
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    \1\ So in law. There is no subsection (j) in section 464D.
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                   interagency coordinating committee
    Sec. 464E. [285m-5] (a) The Secretary may establish a 
committee to be known as the Deafness and Other Communication 
Disorders Interagency Coordinating Committee (hereafter in this 
section referred to as the ``Coordinating Committee'').
    (b) The Coordinating Committee shall, with respect to 
deafness and other communication disorders--
            (1) provide for the coordination of the activities 
        of the national research institutes; and
            (2) coordinate the aspects of all Federal health 
        programs and activities relating to deafness and other 
        communication disorders in order to assure the adequacy 
        and technical soundness of such programs and activities 
        and in order to provide for the full communication and 
        exchange of information necessary to maintain adequate 
        coordination of such programs and activities.
    (c) The Coordinating Committee shall be composed of the 
directors of each of the national research institutes and 
divisions involved in research with respect to deafness and 
other communication disorders and representatives of all other 
Federal departments and agencies whose programs involve health 
functions or responsibilities relevant to deafness and other 
communication disorders.
    (d) The Coordinating Committee shall be chaired by the 
Director of NIH (or the designee of the Director). The 
Committee shall meet at the call of the chair, but not less 
often than four times a year.
                 limitation on administrative expenses
    Sec. 464F. [285m-6] With respect to amounts appropriated 
for a fiscal year for the National Institutes of Health, the 
limitation established in section 408(a)(1) on the expenditure 
of such amounts for administrative expenses shall apply to 
administrative expenses of the National Institute on Deafness 
and Other Communication Disorders.

     Subpart 14--National Institute on Alcohol Abuse and Alcoholism

                          purpose of institute
    Sec. 464H. [285n] (a) In General.--The general purpose of 
the National Institute on Alcohol Abuse and Alcoholism 
(hereafter in this subpart referred to as the ``Institute'') is 
the conduct and support of biomedical and behavioral research, 
health services research, research training, and health 
information dissemination with respect to the prevention of 
alcohol abuse and the treatment of alcoholism.
    (b) Research Program.--The research program established 
under this subpart shall encompass the social, behavioral, and 
biomedical etiology, mental and physical health consequences, 
and social and economic consequences of alcohol abuse and 
alcoholism. In carrying out the program, the Director of the 
Institute is authorized to--
            (1) collect and disseminate through publications 
        and other appropriate means (including the development 
        of curriculum materials), information as to, and the 
        practical application of, the research and other 
        activities under the program;
            (2) make available research facilities of the 
        Public Health Service to appropriate public 
        authorities, and to health officials and scientists 
        engaged in special study;
            (3) make grants to universities, hospitals, 
        laboratories, and other public or nonprofit 
        institutions, and to individuals for such research 
        projects as are recommended by the National Advisory 
        Council on Alcohol Abuse and Alcoholism, giving special 
        consideration to projects relating to--
                    (A) the relationship between alcohol abuse 
                and domestic violence,
                    (B) the effects of alcohol use during 
                pregnancy,
                    (C) the impact of alcoholism and alcohol 
                abuse on the family, the workplace, and systems 
                for the delivery of health services,
                    (D) the relationship between the abuse of 
                alcohol and other drugs,
                    (E) the effect on the incidence of alcohol 
                abuse and alcoholism of social pressures, legal 
                requirements respecting the use of alcoholic 
                beverages, the cost of such beverages, and the 
                economic status and education of users of such 
                beverages,
                    (F) the interrelationship between alcohol 
                use and other health problems,
                    (G) the comparison of the cost and 
                effectiveness of various treatment methods for 
                alcoholism and alcohol abuse and the 
                effectiveness of prevention and intervention 
                programs for alcoholism and alcohol abuse, and
                    (H) alcoholism and alcohol abuse among 
                women;
            (4) secure from time to time and for such periods 
        as he deems advisable, the assistance and advice of 
        experts, scholars, and consultants from the United 
        States or abroad;
            (5) promote the coordination of research programs 
        conducted by the Institute, and similar programs 
        conducted by the National Institute of Drug Abuse and 
        by other departments, agencies, organizations, and 
        individuals, including all National Institutes of 
        Health research activities which are or may be related 
        to the problems of individuals suffering from 
        alcoholism or alcohol abuse or those of their families 
        or the impact of alcohol abuse on other health 
        problems;
            (6) conduct an intramural program of biomedical, 
        behavioral, epidemiological, and social research, 
        including research into the most effective means of 
        treatment and service delivery, and including research 
        involving human subjects, which is--
                    (A) located in an institution capable of 
                providing all necessary medical care for such 
                human subjects, including complete 24-hour 
                medical diagnostic services by or under the 
                supervision of physicians, acute and intensive 
                medical care, including 24-hour emergency care, 
                psychiatric care, and such other care as is 
                determined to be necessary for individuals 
                suffering from alcoholism and alcohol abuse; 
                and
                    (B) associated with an accredited medical 
                or research training institution;
            (7) for purposes of study, admit and treat at 
        institutions, hospitals, and stations of the Public 
        Health Service, persons not otherwise eligible for such 
        treatment;
            (8) provide to health officials, scientists, and 
        appropriate public and other nonprofit institutions and 
        organizations, technical advice and assistance on the 
        application of statistical and other scientific 
        research methods to experiments, studies, and surveys 
        in health and medical fields;
            (9) enter into contracts under this title without 
        regard to sections 3648 and 3709 of the Revised 
        Statutes (31 U.S.C. 529; \1\ 41 U.S.C. 5); and
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    \1\ Now codified to section 3324 of title 31, United States Code.
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            (10) adopt, upon recommendation of the National 
        Advisory Council on Alcohol Abuse and Alcoholism, such 
        additional means as he deems necessary or appropriate 
        to carry out the purposes of this section.
    (c) Collaboration.--The Director of the Institute shall 
collaborate with the Administrator of the Substance Abuse and 
Mental Health Services Administration in focusing the services 
research activities of the Institute and in disseminating the 
results of such research to health professionals and the 
general public.
                   associate director for prevention
    Sec. 464I. [285n-1] (a) In General.--There shall be in the 
Institute an Associate Director for Prevention who shall be 
responsible for the full-time coordination and promotion of the 
programs in the Institute concerning the prevention of alcohol 
abuse and alcoholism. The Associate Director shall be appointed 
by the Director of the Institute from individuals who because 
of their professional training or expertise are experts in 
alcohol abuse and alcoholism or the prevention of such.
    (b) Biennial Report.--The Associate Director for Prevention 
shall prepare for inclusion in the biennial report made under 
section 407 a description of the prevention activities of the 
Institute, including a description of the staff and resources 
allocated to those activities.

                    national alcohol research center

    Sec. 464J. [285n-2] (a) The Secretary acting through the 
Institute may designate National Alcohol Research Centers for 
the purpose of interdisciplinary research relating to 
alcoholism and other biomedical, behavioral, and social issues 
related to alcoholism and alcohol abuse. No entity may be 
designated as a Center unless an application therefor has been 
submitted to, and approved by, the Secretary. Such an 
application shall be submitted in such manner and contain such 
information as the Secretary may reasonably require. The 
Secretary may not approve such an application unless--
            (1) the application contains or is supported by 
        reasonable assurances that--
                    (A) the applicant has the experience, or 
                capability, to conduct, through biomedical, 
                behavioral, social, and related disciplines, 
                long-term research on alcoholism and other 
                alcohol problems and to provide coordination of 
                such research among such disciplines;
                    (B) the applicant has available to it 
                sufficient facilities (including laboratory, 
                reference, and data analysis facilities) to 
                carry out the research plan contained in the 
                application,
                    (C) the applicant has facilities and 
                personnel to provide training in the prevention 
                and treatment of alcoholism and other alcohol 
                problems;
                    (D) the applicant has the capacity to train 
                predoctoral and postdoctoral students for 
                careers in research on alcoholism and other 
                alcohol problems;
                    (E) the applicant has the capacity to 
                conduct courses on alcohol problems and 
                research on alcohol problems for undergraduate 
                and graduate students, and medical and 
                osteopathic, nursing, social work, and other 
                specialized graduate students; and
                    (F) the applicant has the capacity to 
                conduct programs of continuing education in 
                such medical, legal, and social service fields 
                as the Secretary may require. \1\
---------------------------------------------------------------------------
    \1\ So in law. See section 16(a)(5) of Public Law 96-180 (93 Stat. 
1305). The period probably should be ``; and''. (Section 464J formerly 
was section 504 of another law. The amendment made by Public Law 96-180 
was directed to section 504 of that other law, which was Public Law 91-
616.)
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            (2) the application contains a detailed five-year 
        plan for research relating to alcoholism and other 
        alcohol problems.
    (b) The Secretary shall, under such conditions as the 
Secretary may reasonably require, make annual grants to Centers 
which have been designated under this section. No funds 
provided under a grant under this subsection may be used for 
the purchase of any land or the purchase, construction, 
preservation, or repair of any building. For the purposes of 
the preceding sentence, the term ``construction'' has the 
meaning given that term by section 701(1). \2\ The Secretary 
shall include in the grants made under this section for fiscal 
year beginning after September 30, 1981, a grant to a 
designated Center for research on the effects of alcohol on the 
elderly.
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    \2\ So in law. See section 2(a) of Public Law 102-352 (106 Stat. 
938). Section 701(1) does not provide a definition for the term 
``construction'', but former section 701(1) did provide such a 
definition. Public Law 102-408 amended title VII generally; definitions 
for the title are now provided in section 799, and that section does 
not define the term ``construction''.
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              Subpart 15--National Institute on Drug Abuse

                          purpose of institute
    Sec. 464L. [285o] (a) In General.--The general purpose of 
the National Institute on Drug Abuse (hereafter in this subpart 
referred to as the ``Institute'') is the conduct and support of 
biomedical and behavioral research, health services research, 
research training, and health information dissemination with 
respect to the prevention of drug abuse and the treatment of 
drug abusers.
    (b) Research Program.--The research program established 
under this subpart shall encompass the social, behavioral, and 
biomedical etiology, mental and physical health consequences, 
and social and economic consequences of drug abuse. In carrying 
out the program, the Director of the Institute shall give 
special consideration to projects relating to drug abuse among 
women (particularly with respect to pregnant women).
    (c) Collaboration.--The Director of the Institute shall 
collaborate with the Substance Abuse and Mental Health Services 
Administration in focusing the services research activities of 
the Institute and in disseminating the results of such research 
to health professionals and the general public.
                   associate director for prevention
    Sec. 464M. [285o-1] (a) In General.--There shall be in the 
Institute an Associate Director for Prevention who shall be 
responsible for the full-time coordination and promotion of the 
programs in the Institute concerning the prevention of drug 
abuse. The Associate Director shall be appointed by the 
Director of the Institute from individuals who because of their 
professional training or expertise are experts in drug abuse 
and the prevention of such abuse.
    (b) Report.--The Associate Director for Prevention shall 
prepare for inclusion in the biennial report made under section 
407 a description of the prevention activities of the 
Institute, including a description of the staff and resources 
allocated to those activities.
                      drug abuse research centers
    Sec. 464N. [285o-2] (a) Authority.--The Director of the 
Institute may designate National Drug Abuse Research Centers 
for the purpose of interdisciplinary research relating to drug 
abuse and other biomedical, behavioral, and social issues 
related to drug abuse. No entity may be designated as a Center 
unless an application therefore has been submitted to, and 
approved by, the Secretary. Such an application shall be 
submitted in such manner and contain such information as the 
Secretary may reasonably require. The Secretary may not approve 
such an application unless--
            (1) the application contains or is supported by 
        reasonable assurances that--
                    (A) the applicant has the experience, or 
                capability, to conduct, through biomedical, 
                behavioral, social, and related disciplines, 
                long-term research on drug abuse and to provide 
                coordination of such research among such 
                disciplines;
                    (B) the applicant has available to it 
                sufficient facilities (including laboratory, 
                reference, and data analysis facilities) to 
                carry out the research plan contained in the 
                application;
                    (C) the applicant has facilities and 
                personnel to provide training in the prevention 
                and treatment of drug abuse;
                    (D) the applicant has the capacity to train 
                predoctoral and postdoctoral students for 
                careers in research on drug abuse;
                    (E) the applicant has the capacity to 
                conduct courses on drug abuse problems and 
                research on drug abuse for undergraduate and 
                graduate students, and medical and osteopathic, 
                nursing, social work, and other specialized 
                graduate students; and
                    (F) the applicant has the capacity to 
                conduct programs of continuing education in 
                such medical, legal, and social service fields 
                as the Secretary may require. \1\
---------------------------------------------------------------------------
    \1\ So in law. See section 123(b) of Public Law 102-321 (106 Stat. 
361). The period probably should be ``; and''.
---------------------------------------------------------------------------
            (2) the application contains a detailed five-year 
        plan for research relating to drug abuse.
    (b) Grants.--The Director of the Institute shall, under 
such conditions as the Secretary may reasonably require, make 
annual grants to Centers which have been designated under this 
section. No funds provided under a grant under this subsection 
may be used for the purchase of any land or the purchase, 
construction, preservation, or repair of any building. For the 
purposes of the preceding sentence, the term ``construction'' 
has the meaning given that term by section 701(1). \2\
---------------------------------------------------------------------------
    \2\ See footnote for section 464J(b).
---------------------------------------------------------------------------
    (c) Drug Abuse and Addition \3\ Research.--
---------------------------------------------------------------------------
    \3\ Probably should be ``Addiction''. See section 2203 of Public 
Law 107-273 (116 Stat. 1794).
---------------------------------------------------------------------------
            (1) Grants or cooperative agreements.--The Director 
        of the Institute may make grants or enter into 
        cooperative agreements to expand the current and 
        ongoing interdisciplinary research and clinical trials 
        with treatment centers of the National Drug Abuse 
        Treatment Clinical Trials Network relating to drug 
        abuse and addiction, including related biomedical, 
        behavioral, and social issues.
            (2) Use of funds.--Amounts made available under a 
        grant or cooperative agreement under paragraph (1) for 
        drug abuse and addiction may be used for research and 
        clinical trials relating to--
                    (A) the effects of drug abuse on the human 
                body, including the brain;
                    (B) the addictive nature of drugs and how 
                such effects differ with respect to different 
                individuals;
                    (C) the connection between drug abuse and 
                mental health;
                    (D) the identification and evaluation of 
                the most effective methods of prevention of 
                drug abuse and addiction;
                    (E) the identification and development of 
                the most effective methods of treatment of drug 
                addiction, including pharmacological 
                treatments;
                    (F) risk factors for drug abuse;
                    (G) effects of drug abuse and addiction on 
                pregnant women and their fetuses; and
                    (H) cultural, social, behavioral, 
                neurological, and psychological reasons that 
                individuals abuse drugs, or refrain from 
                abusing drugs.
            (3) Research results.--The Director shall promptly 
        disseminate research results under this subsection to 
        Federal, State, and local entities involved in 
        combating drug abuse and addiction.
                             office on aids
    Sec. 464O. [285o-3] The Director of the Institute shall 
establish within the Institute an Office on AIDS. The Office 
shall be responsible for the coordination of research and 
determining the direction of the Institute with respect to AIDS 
research related to--
            (1) primary prevention of the spread of HIV, 
        including transmission via drug abuse;
            (2) drug abuse services research; and
            (3) other matters determined appropriate by the 
        Director.
                     medication development program
    Sec. 464P. [285o-4] (a) Establishment.--There is 
established in the Institute a Medication Development Program 
through which the Director of such Institute shall--
            (1) conduct periodic meetings with the Commissioner 
        of Food and Drugs to discuss measures that may 
        facilitate the approval process of drug abuse 
        treatments;
            (2) encourage and promote (through grants, 
        contracts, international collaboration, or otherwise) 
        expanded research programs, investigations, 
        experiments, community trials, and studies, into the 
        development and use of medications to treat drug 
        addiction;
            (3) establish or provide for the establishment of 
        research facilities;
            (4) report on the activities of other relevant 
        agencies relating to the development and use of 
        pharmacotherapeutic treatments for drug addiction;
            (5) collect, analyze, and disseminate data useful 
        in the development and use of pharmacotherapeutic 
        treatments for drug addiction and collect, catalog, 
        analyze, and disseminate through international 
        channels, the results of such research;
            ctly or through grants, contracts, or cooperative 
        agreements, support training in the fundamental 
        sciences and clinical disciplines related to the 
        pharmacotherapeutic treatment of drug abuse, including 
        the use of training stipends, fellowships, and awards 
        where appropriate; and
            (7) coordinate the activities conducted under this 
        section with related activities conducted within the 
        National Institute on Alcohol Abuse and Alcoholism, the 
        National Institute of Mental Health, and other 
        appropriate institutes and shall consult with the 
        Directors of such Institutes.
    (b) Duties.--In carrying out the activities described in 
subsection (a), the Director of the Institute--
            (1) shall collect and disseminate through 
        publications and other appropriate means, information 
        pertaining to the research and other activities under 
        this section;
            (2) shall make grants to or enter into contracts 
        and cooperative agreements with individuals and public 
        and private entities to further the goals of the 
        program;
            (3) may, in accordance with section 496, and in 
        consultation with the National Advisory Council on Drug 
        Abuse, acquire, construct, improve, repair, operate, 
        and maintain pharmacotherapeutic research centers, 
        laboratories, and other necessary facilities and 
        equipment, and such other real or personal property as 
        the Director determines necessary, and may, in 
        consultation with such Advisory Council, make grants 
        for the construction or renovation of facilities to 
        carry out the purposes of this section;
            (4) may accept voluntary and uncompensated 
        services;
            (5) may accept gifts, or donations of services, 
        money, or property, real, personal, or mixed, tangible 
        or intangible; and
            (6) shall take necessary action to ensure that all 
        channels for the dissemination and exchange of 
        scientific knowledge and information are maintained 
        between the Institute and the other scientific, 
        medical, and biomedical disciplines and organizations 
        nationally and internationally.
    (c) Report.--
            (1) In general.--Not later than December 31, 1992, 
        and each December 31 thereafter, the Director of the 
        Institute shall submit to the Office of National Drug 
        Control Policy established under section 1002 of the 
        Anti-Drug Abuse Act of 1988 (21 U.S.C. 1501) a report, 
        in accordance with paragraph (3), that describes the 
        objectives and activities of the program assisted under 
        this section.
            (2) National drug control strategy.--The Director 
        of National Drug Control Policy shall incorporate, by 
        reference or otherwise, each report submitted under 
        this subsection in the National Drug Control Strategy 
        submitted the following February 1 under section 1005 
        of the Anti-Drug Abuse Act of 1988 (21 U.S.C. 1504).
    (d) Definition.--For purposes of this section, the term 
``pharmacotherapeutics'' means medications used to treat the 
symptoms and disease of drug abuse, including medications to--
            (1) block the effects of abused drugs;
            (2) reduce the craving for abused drugs;
            (3) moderate or eliminate withdrawal symptoms;
            (4) block or reverse the toxic effect of abused 
        drugs; or
            (5) prevent relapse in persons who have been 
        detoxified from drugs of abuse.

            Subpart 16--National Institute of Mental Health

                          purpose of institute
    Sec. 464R. [285p] (a) In General.--The general purpose of 
the National Institute of Mental Health (hereafter in this 
subpart referred to as the ``Institute'') is the conduct and 
support of biomedical and behavioral research, health services 
research, research training, and health information 
dissemination with respect to the cause, diagnosis, treatment, 
control and prevention of mental illness.
    (b) Research Program.--The research program established 
under this subpart shall include support for biomedical and 
behavioral neuroscience and shall be designed to further the 
treatment and prevention of mental illness, the promotion of 
mental health, and the study of the psychological, social and 
legal factors that influence behavior.
    (c) Collaboration.--The Director of the Institute shall 
collaborate with the Administrator of the Substance Abuse and 
Mental Health Services Administration in focusing the services 
research activities of the Institute and in disseminating the 
results of such research to health professionals and the 
general public.
    (d) Information With Respect to Suicide.--
            (1) In general.--The Director of the Institute 
        shall--
                    (A) develop and publish information with 
                respect to the causes of suicide and the means 
                of preventing suicide; and
                    (B) make such information generally 
                available to the public and to health 
                professionals.
            (2) Youth suicide.--Information described in 
        paragraph (1) shall especially relate to suicide among 
        individuals under 24 years of age.
    (e) Associate Director for Special Populations.--
            (1) In general.--The Director of the Institute 
        shall designate an Associate Director for Special 
        Populations.
            (2) Duties.--The Associate Director for Special 
        Populations shall--
                    (A) develop and coordinate research 
                policies and programs to assure increased 
                emphasis on the mental health needs of women 
                and minority populations;
                    (B) support programs of basic and applied 
                social and behavioral research on the mental 
                health problems of women and minority 
                populations;
                    (C) study the effects of discrimination on 
                institutions and individuals, including 
                majority institutions and individuals;
                    (D) support and develop research designed 
                to eliminate institutional discrimination; and
                    (E) provide increased emphasis on the 
                concerns of women and minority populations in 
                training programs, service delivery programs, 
                and research endeavors of the Institute.
                   associate director for prevention
    Sec. 464S. [285p-1] (a) In General.--There shall be in the 
Institute an Associate Director for Prevention who shall be 
responsible for the full-time coordination and promotion of the 
programs in the Institute concerning the prevention of mental 
disorder. The Associate Director shall be appointed by the 
Director of the Institute from individuals who because of their 
professional training or expertise are experts in mental 
disorder and the prevention of such.
    (b) Report.--The Associate Director for Prevention shall 
prepare for inclusion in the biennial report made under section 
407 a description of the prevention activities of the 
Institute, including a description of the staff and resources 
allocated to those activities.
                 office of rural mental health research
    Sec. 464T. [285p-2] (a) In General.--There is established 
within the Institute an office to be known as the Office of 
Rural Mental Health Research (hereafter in this section 
referred to as the ``Office''). The Office shall be headed by a 
director, who shall be appointed by the Director of such 
Institute from among individuals experienced or knowledgeable 
in the provision of mental health services in rural areas. The 
Secretary shall carry out the authorities established in this 
section acting through the Director of the Office.
    (b) Coordination of Activities.--The Director of the 
Office, in consultation with the Director of the Institute and 
with the Director of the Office of Rural Health Policy, shall--
            (1) coordinate the research activities of the 
        Department of Health and Human Services as such 
        activities relate to the mental health of residents of 
        rural areas; and
            (2) coordinate the activities of the Office with 
        similar activities of public and nonprofit private 
        entities.
    (c) Research, Demonstrations, Evaluations, and 
Dissemination.--The Director of the Office may, with respect to 
the mental health of adults and children residing in rural 
areas--
            (1) conduct research on conditions that are unique 
        to the residents of rural areas, or more serious or 
        prevalent in such residents;
            (2) conduct research on improving the delivery of 
        services in such areas; and
            (3) disseminate information to appropriate public 
        and nonprofit private entities.
    (d) Authority Regarding Grants and Contracts.--The Director 
of the Office may carry out the authorities established in 
subsection (c) directly and through grants, cooperative 
agreements, or contracts with public or nonprofit private 
entities.
                             office on aids
    Sec. 464U. [285p-3] The Director of the Institute shall 
establish within the Institute an Office on AIDS. The Office 
shall be responsible for the coordination of research and 
determining the direction of the Institute with respect to AIDS 
research related to--
            (1) primary prevention of the spread of HIV, 
        including transmission via sexual behavior;
            (2) mental health services research; and
            (3) other matters determined appropriate by the 
        Director.

           Subpart 17--National Institute of Nursing Research

                        purpose of the institute
    Sec. 464V. [285q] The general purpose of the National 
Institute of Nursing Research (in this subpart referred to as 
the ``Institute'') is the conduct and support of, and 
dissemination of information respecting, basic and clinical 
nursing research, training, and other programs in patient care 
research.
                          specific authorities
    Sec. 464W. [285q-1] To carry out section 464V, the Director 
of the Institute may provide research training and instruction 
and establish, in the Institute and other nonprofit 
institutions, research traineeships and fellowships in the 
study and investigation of the prevention of disease, health 
promotion, and the nursing care of individuals with and the 
families of individuals with acute and chronic illnesses. The 
Director of the Institute may provide individuals receiving 
such training and instruction or such traineeships or 
fellowships with such stipends and allowances (including 
amounts for travel and subsistence and dependency allowances) 
as the Director determines necessary. The Director may make 
grants to nonprofit institutions to provide such training and 
instruction and traineeships and fellowships.
                            advisory council
    Sec. 464X. [285q-2] (a)(1) The Secretary shall appoint an 
advisory council for the Institute which shall advise, assist, 
consult with, and make recommendations to the Secretary and the 
Director of the Institute on matters related to the activities 
carried out by and through the Institute and the policies 
respecting such activities.
    (2) The advisory council for the Institute may recommend to 
the Secretary acceptance, in accordance with section 2701, \1\ 
of conditional gifts for study, investigations, and research 
and for the acquisition of grounds or construction, equipping, 
or maintenance of facilities for the Institute.
---------------------------------------------------------------------------
    \1\ Probably should be section 231. That section formerly was 
section 2701, and was redesignated by subsection (a)(2) of section 2010 
of Public Law 103-43 (107 Stat. 213). Subsection (b)(5) of such section 
purported to conform the above reference, but the amendment cannot be 
executed because the amendment applied to the incorrect section. (The 
conforming amendment applied to section 485. Section 464X formerly was 
section 485, and was redesignated by section 1511(b)(2)(B) of Public 
Law 103-43 (107 Stat. 179).)
---------------------------------------------------------------------------
    (3) The advisory council for the Institute--
            (A)(i) may make recommendations to the Director of 
        the Institute respecting research conducted at the 
        Institute,
            (ii) may review applications for grants and 
        cooperative agreements for research or training and 
        recommend for approval applications for projects which 
        show promise of making valuable contributions to human 
        knowledge, and
            (iii) may review any grant, contract, or 
        cooperative agreement proposed to be made or entered 
        into by the Institute;
            (B) may collect, by correspondence or by personal 
        investigation, information as to studies which are 
        being carried on in the United States or any other 
        country as to the diseases, disorders, or other aspects 
        of human health with respect to which the Institute is 
        concerned and with the approval of the Director of the 
        Institute make available such information through 
        appropriate publications for the benefit of public and 
        private health entities and health professions 
        personnel and scientists and for the information of the 
        general public; and
            (C) may appoint subcommittees and convene workshops 
        and conferences.
    (b)(1) The advisory council shall consist of ex officio 
members and not more than eighteen members appointed by the 
Secretary.
    (2) The ex officio members of the advisory council shall 
consist of--
            (A) the Secretary, the Director of NIH, the 
        Director of the Institute, the chief nursing officer of 
        the Department of Veterans Affairs, the Assistant 
        Secretary of Defense for Health Affairs, the Director 
        of the Division of Nursing of the Health Resources and 
        Services Administration (or the designees of such 
        officers), and
            (B) such additional officers or employees of the 
        United States as the Secretary determines necessary for 
        the advisory council to effectively carry out its 
        functions.
    (3) The members of the advisory council who are not ex 
officio members shall be appointed as follows:
            (A) Two-thirds of the members shall be appointed by 
        the Secretary from among the leading representatives of 
        the health and scientific disciplines (including public 
        health and the behavioral or social sciences) relevant 
        to the activities of the Institute. Of the members 
        appointed pursuant to this subparagraph, at least seven 
        shall be professional nurses who are recognized experts 
        in the area of clinical practice, education, or 
        research.
            (B) One-third of the members shall be appointed by 
        the Secretary from the general public and shall include 
        leaders in fields of public policy, law, health policy, 
        economics, and management.
    (4) Members of the advisory council who are officers or 
employees of the United States shall not receive any 
compensation for service on the advisory council. The other 
members of the advisory council shall receive, for each day 
(including traveltime) they are engaged in the performance of 
the functions of the advisory council, compensation at rates 
not to exceed the daily equivalent of the annual rate in effect 
for grade GS-18 of the General Schedule.
    (c) The term of office of an appointed member of the 
advisory council is four years, except that any member 
appointed to fill a vacancy for an unexpired term shall be 
appointed for the remainder of such term and the Secretary 
shall make appointments to an advisory council in such a manner 
as to ensure that the terms of the members do not all expire in 
the same year. A member may serve after the expiration of the 
member's term until a successor has taken office. A member who 
has been appointed for a term of four years may not be 
reappointed to an advisory council before two years from the 
date of expiration of such term of office. If a vacancy occurs 
in the advisory council among the appointed members, the 
Secretary shall make an appointment to fill the vacancy within 
90 days from the date the vacancy occurs.
    (d) The chairman of the advisory council shall be selected 
by the Secretary from among the appointed members, except that 
the Secretary may select the Director of the Institute to be 
the chairman of the advisory council. The term of office of the 
chairman shall be two years.
    (e) The advisory council shall meet at the call of the 
chairman or upon the request of the Director of the Institute, 
but at least three times each fiscal year. The location of the 
meetings of the advisory council is subject to the approval of 
the Director of the Institute.
    (f) The Director of the Institute shall designate a member 
of the staff of the Institute to serve as the executive 
secretary of the advisory council. The Director of the 
Institute shall make available to the advisory council such 
staff, information, and other assistance as it may require to 
carry out its functions. The Director of the Institute shall 
provide orientation and training for new members of the 
advisory council to provide them with such information and 
training as may be appropriate for their effective 
participation in the functions of the advisory council.
    (g) The advisory council may prepare, for inclusion in the 
biennial report made under section 464Y, (1) comments 
respecting the activities of the advisory council in the fiscal 
years respecting which the report is prepared, (2) comments on 
the progress of the Institute in meeting its objectives, and 
(3) recommendations respecting the future directions and 
program and policy emphasis of the Institute. The advisory 
council may prepare such additional reports as it may determine 
appropriate.
                            biennial report
    Sec. 464Y. [285q-3] The Director of the Institute after 
consultation with the advisory council for the Institute, shall 
prepare for inclusion in the biennial report made under section 
403 a biennial report which shall consist of a description of 
the activities of the Institute and program policies of the 
Director of the Institute in the fiscal years respecting which 
the report is prepared. The Director of the Institute may 
prepare such additional reports as the Director determines 
appropriate. The Director of the Institute shall provide the 
advisory council of the Institute an opportunity for the 
submission of the written comments referred to in section 
464X(g).

Subpart 18--National Institute of Biomedical Imaging and Bioengineering

                        purpose of the institute
    Sec. 464z. [285r] (a) The general purpose of the National 
Institute of Biomedical Imaging and Bioengineering (in this 
section referred to as the ``Institute'') is the conduct and 
support of research, training, the dissemination of health 
information, and other programs with respect to biomedical 
imaging, biomedical engineering, and associated technologies 
and modalities with biomedical applications (in this section 
referred to as ``biomedical imaging and bioengineering'').
    (b)(1) The Director of the Institute, with the advice of 
the Institute's advisory council, shall establish a National 
Biomedical Imaging and Bioengineering Program (in this section 
referred to as the ``Program'').
    (2) Activities under the Program shall include the 
following with respect to biomedical imaging and 
bioengineering:
            (A) Research into the development of new techniques 
        and devices.
            (B) Related research in physics, engineering, 
        mathematics, computer science, and other disciplines.
            (C) Technology assessments and outcomes studies to 
        evaluate the effectiveness of biologics, materials, 
        processes, devices, procedures, and informatics.
            (D) Research in screening for diseases and 
        disorders.
            (E) The advancement of existing imaging and 
        bioengineering modalities, including imaging, 
        biomaterials, and informatics.
            (F) The development of target-specific agents to 
        enhance images and to identify and delineate disease.
            (G) The development of advanced engineering and 
        imaging technologies and techniques for research from 
        the molecular and genetic to the whole organ and body 
        levels.
            (H) The development of new techniques and devices 
        for more effective interventional procedures (such as 
        image-guided interventions).
    (3)(A) With respect to the Program, the Director of the 
Institute shall prepare and transmit to the Secretary and the 
Director of NIH a plan to initiate, expand, intensify, and 
coordinate activities of the Institute with respect to 
biomedical imaging and bioengineering. The plan shall include 
such comments and recommendations as the Director of the 
Institute determines appropriate. The Director of the Institute 
shall periodically review and revise the plan and shall 
transmit any revisions of the plan to the Secretary and the 
Director of NIH.
    (B) The plan under subparagraph (A) shall include the 
recommendations of the Director of the Institute with respect 
to the following:
            (i) Where appropriate, the consolidation of 
        programs of the National Institutes of Health for the 
        express purpose of enhancing support of activities 
        regarding basic biomedical imaging and bioengineering 
        research.
            (ii) The coordination of the activities of the 
        Institute with related activities of the other agencies 
        of the National Institutes of Health and with related 
        activities of other Federal agencies.
    (c) The establishment under section 406 of an advisory 
council for the Institute is subject to the following:
            (1) The number of members appointed by the 
        Secretary shall be 12.
            (2) Of such members--
                    (A) six members shall be scientists, 
                engineers, physicians, and other health 
                professionals who represent disciplines in 
                biomedical imaging and bioengineering and who 
                are not officers or employees of the United 
                States; and
                    (B) six members shall be scientists, 
                engineers, physicians, and other health 
                professionals who represent other disciplines 
                and are knowledgeable about the applications of 
                biomedical imaging and bioengineering in 
                medicine, and who are not officers or employees 
                of the United States.
            (3) In addition to the ex officio members specified 
        in section 406(b)(2), the ex officio members of the 
        advisory council shall include the Director of the 
        Centers for Disease Control and Prevention, the 
        Director of the National Science Foundation, and the 
        Director of the National Institute of Standards and 
        Technology (or the designees of such officers).

  H2  deg.Subpart 19--National Human Genome Research Institute

                       purpose of the center \1\
---------------------------------------------------------------------------
    \1\ The word ``center'' in the section heading probably should read 
``institute''. Section 101(c)(4)(C) of Public Law 109-482 (120 Stat. 
3675) struck ``center'' each place such term appeared in this subpart 
and inserted ``institute''. However, this amendment was not effective 
with respect to the section heading because the word ``center'' appears 
in small caps.
---------------------------------------------------------------------------
    Sec. 464z-1. [285s] (a) The general purpose of the National 
Human Genome Research Institute (in this subpart referred to as 
the ``Institute'') is to characterize the structure and 
function of the human genome, including the mapping and 
sequencing of individual genes. Such purpose includes--
            (1) planning and coordinating the research goal of 
        the genome project;
            (2) reviewing and funding research proposals;
            (3) developing training programs;
            (4) coordinating international genome research;
            (5) communicating advances in genome science to the 
        public; and
            (6) reviewing and funding proposals to address the 
        ethical and legal issues associated with the genome 
        project (including legal issues regarding patents).
    (b) The Director of the Institute may conduct and support 
research training--
            (1) for which fellowship support is not provided 
        under section 487; and
            (2) that is not residency training of physicians or 
        other health professionals.
    (c)(1) Except as provided in paragraph (2), of the amounts 
appropriated to carry out subsection (a) for a fiscal year, the 
Director of the Institute shall make available not less than 5 
percent for carrying out paragraph (6) of such subsection.
    (2) With respect to providing funds under subsection (a)(6) 
for proposals to address the ethical issues associated with the 
genome project, paragraph (1) shall not apply for a fiscal year 
if the Director of the Institute certifies to the Committee on 
Energy and Commerce of the House of Representatives, and to the 
Committee on Labor and Human Resources of the Senate, that the 
Director has determined that an insufficient number of such 
proposals meet the applicable requirements of sections 491 and 
492.

     Subpart 20--National Institute on Minority Health and Health 
                              Disparities

SEC. 464Z-3. [285T] PURPOSE OF CENTER \1\.
---------------------------------------------------------------------------

    \1\ The word ``CENTER'' in the section heading for section 464z-3 
probably should read ``INSTITUTE''. See amendment made by section 
10334(c)(1)(D)(iii) of Public Law 111-148.
---------------------------------------------------------------------------
    (a) In General.--The general purpose of the National 
Institute on Minority Health and Health Disparities (in this 
subpart referred to as the ``Institute'') is the conduct and 
support of research, training, dissemination of information, 
and other programs with respect to minority health conditions 
and other populations with health disparities.
    (b) Priorities.--The Director of the Institute shall in 
expending amounts appropriated under this subpart give priority 
to conducting and supporting minority health disparities 
research.
    (c) Minority Health Disparities Research.--For purposes of 
this subpart:
            (1) The term ``minority health disparities 
        research'' means basic, clinical, and behavioral 
        research on minority health conditions (as defined in 
        paragraph (2)), including research to prevent, 
        diagnose, and treat such conditions.
            (2) The term ``minority health conditions'', with 
        respect to individuals who are members of minority 
        groups, means all diseases, disorders, and conditions 
        (including with respect to mental health and substance 
        abuse)--
                    (A) unique to, more serious, or more 
                prevalent in such individuals;
                    (B) for which the factors of medical risk 
                or types of medical intervention may be 
                different for such individuals, or for which it 
                is unknown whether such factors or types are 
                different for such individuals; or
                    (C) with respect to which there has been 
                insufficient research involving such 
                individuals as subjects or insufficient data on 
                such individuals.
            (3) The term ``minority group'' has the meaning 
        given the term ``racial and ethnic minority group'' in 
        section 1707.
            (4) The terms ``minority'' and ``minorities'' refer 
        to individuals from a minority group.
    (d) Health Disparity Populations.--For purposes of this 
subpart:
            (1) A population is a health disparity population 
        if, as determined by the Director of the Institute 
        after consultation with the Director of the Agency for 
        Healthcare Research and Quality, there is a significant 
        disparity in the overall rate of disease incidence, 
        prevalence, morbidity, mortality, or survival rates in 
        the population as compared to the health status of the 
        general population.
            (2) The Director shall give priority consideration 
        to determining whether minority groups qualify as 
        health disparity populations under paragraph (1).
            (3) The term ``health disparities research'' means 
        basic, clinical, and behavioral research on health 
        disparity populations (including individual members and 
        communities of such populations) that relates to health 
        disparities as defined under paragraph (1), including 
        the causes of such disparities and methods to prevent, 
        diagnose, and treat such disparities.
    (e) Coordination of Activities.--The Director of the 
Institute shall act as the primary Federal official with 
responsibility for coordinating all minority health disparities 
research and other health disparities research conducted or 
supported by the National Institutes of Health, and--
            (1) shall represent the health disparities research 
        program of the National Institutes of Health, including 
        the minority health disparities research program, at 
        all relevant Executive branch task forces, committees 
        and planning activities; and
            (2) shall maintain communications with all relevant 
        Public Health Service agencies, including the Indian 
        Health Service, and various other departments of the 
        Federal Government to ensure the timely transmission of 
        information concerning advances in minority health 
        disparities research and other health disparities 
        research between these various agencies for 
        dissemination to affected communities and health care 
        providers.
    (f) Collaborative Comprehensive Plan and Budget.--
            (1) In general.--Subject to the provisions of this 
        section and other applicable law, the Director of NIH, 
        the Director of the Institute, and the directors of the 
        other agencies of the National Institutes of Health in 
        collaboration (and in consultation with the advisory 
        council for the Institute) shall--
                    (A) establish a comprehensive plan and 
                budget for the conduct and support of all 
                minority health disparities research and other 
                health disparities research activities of the 
                agencies of the National Institutes of Health 
                (which plan and budget shall be first 
                established under this subsection not later 
                than 12 months after the date of the enactment 
                of this subpart);
                    (B) ensure that the plan and budget 
                establish priorities among the health 
                disparities research activities that such 
                agencies are authorized to carry out;
                    (C) ensure that the plan and budget 
                establish objectives regarding such activities, 
                describes the means for achieving the 
                objectives, and designates the date by which 
                the objectives are expected to be achieved;
                    (D) ensure that, with respect to amounts 
                appropriated for activities of the Institute, 
                the plan and budget give priority in the 
                expenditure of funds to conducting and 
                supporting minority health disparities 
                research;
                    (E) ensure that all amounts appropriated 
                for such activities are expended in accordance 
                with the plan and budget;
                    (F) review the plan and budget not less 
                than annually, and revise the plan and budget 
                as appropriate;
                    (G) ensure that the plan and budget serve 
                as a broad, binding statement of policies 
                regarding minority health disparities research 
                and other health disparities research 
                activities of the agencies, but do not remove 
                the responsibility of the heads of the agencies 
                for the approval of specific programs or 
                projects, or for other details of the daily 
                administration of such activities, in 
                accordance with the plan and budget; and
                    (H) promote coordination and collaboration 
                among the agencies conducting or supporting 
                minority health or other health disparities 
                research.
            (2) Certain components of plan and budget.--With 
        respect to health disparities research activities of 
        the agencies of the National Institutes of Health, the 
        Director of the Institute shall ensure that the plan 
        and budget under paragraph (1) provide for--
                    (A) basic research and applied research, 
                including research and development with respect 
                to products;
                    (B) research that is conducted by the 
                agencies;
                    (C) research that is supported by the 
                agencies;
                    (D) proposals developed pursuant to 
                solicitations by the agencies and for proposals 
                developed independently of such solicitations; 
                and
                    (E) behavioral research and social sciences 
                research, which may include cultural and 
                linguistic research in each of the agencies.
            (3) Minority health disparities research.--The plan 
        and budget under paragraph (1) shall include a separate 
        statement of the plan and budget for minority health 
        disparities research.
    (g) Participation in Clinical Research.--The Director of 
the Institute shall work with the Director of NIH and the 
directors of the agencies of the National Institutes of Health 
to carry out the provisions of section 492B that relate to 
minority groups.
    (h) Research Endowments.--
            (1) In general.--The Director of the Institute may 
        carry out a program to facilitate minority health 
        disparities research and other health disparities 
        research by providing for research endowments--
            (1) at centers of excellence under section 736; and
            (2) at centers of excellence under section 464z-4. 
        \1\
---------------------------------------------------------------------------
    \1\ So in law. Section 10334(c)(2)(A) of Public Law 111-148 amends 
(h)(1) by striking and inserting text that results in two paragraphs 
(1) and (2). The second paragraph (1) and the first paragraph (2) 
proabbly should be redesignated as subparagraphs (A) and (B), 
respectively (and moving margins to the right so that they align with 
subparagraphs cpmtaomed in paragraph (2)).
---------------------------------------------------------------------------
            (2) Eligibility.--The Director of the Institute may 
        provide for a research endowment under paragraph (1) 
        only if the institution involved meets the following 
        conditions:
                    (A) The institution does not have an 
                endowment that is worth in excess of an amount 
                equal to 50 percent of the national median of 
                endowment funds at institutions that conduct 
                similar biomedical research or training of 
                health professionals.
                    (B) The application of the institution 
                under paragraph (1) regarding a research 
                endowment has been recommended pursuant to 
                technical and scientific peer review and has 
                been approved by the advisory council under 
                subsection (j).
    (i) Certain Activities.--In carrying out subsection (a), 
the Director of the Institute--
            (1) shall assist the Director of the National 
        Institute for Research Resources in carrying out 
        section 481(c)(3) and in committing resources for 
        construction at Institutions of Emerging Excellence;
            (2) shall establish projects to promote cooperation 
        among Federal agencies, State, local, tribal, and 
        regional public health agencies, and private entities 
        in health disparities research; and
            (3) may utilize information from previous health 
        initiatives concerning minorities and other health 
        disparity populations.
    (j) Advisory Council.--
            (1) In general.--The Secretary shall, in accordance 
        with section 406, establish an advisory council to 
        advise, assist, consult with, and make recommendations 
        to the Director of the Institute on matters relating to 
        the activities described in subsection (a), and with 
        respect to such activities to carry out any other 
        functions described in section 406 for advisory 
        councils under such section. Functions under the 
        preceding sentence shall include making recommendations 
        on budgetary allocations made in the plan under 
        subsection (f), and shall include reviewing reports 
        under subsection (k) before the reports are submitted 
        under such subsection.
            (2) Membership.--With respect to the membership of 
        the advisory council under paragraph (1), a majority of 
        the members shall be individuals with demonstrated 
        expertise regarding minority health disparity and other 
        health disparity issues; representatives of communities 
        impacted by minority and other health disparities shall 
        be included; and a diversity of health professionals 
        shall be represented. The membership shall in addition 
        include a representative of the Office of Behavioral 
        and Social Sciences Research under section 404A.
    (h) \1\ Interagency Coordination.--The Director of the 
Institute, as the primary Federal officials with responsibility 
for coordinating all research and activities conducted or 
supported by the National Institutes of Health on minority 
health and health disparities, shall plan, coordinate, review 
and evaluate research and other activities conducted or 
supported by the Institutes and Centers of the National 
Institutes of Health.
---------------------------------------------------------------------------
    \1\ So in law. Section 10334(c)(2)(C) of Public Law 111-148 amends 
section 464z-3 (as redesignated) by adding a subsection (h) at the end. 
Probably should be a subsection (k).
---------------------------------------------------------------------------

SEC. 464Z-4. [285T-1]  CENTERS OF EXCELLENCE FOR RESEARCH EDUCATION AND 
                    TRAINING.

    (a) In General.--The Director of the Institute shall make 
awards of grants or contracts to designated biomedical and 
behavioral research institutions under paragraph (1) of 
subsection (c), or to consortia under paragraph (2) of such 
subsection, for the purpose of assisting the institutions in 
supporting programs of excellence in biomedical and behavioral 
research training for individuals who are members of minority 
health disparity populations or other health disparity 
populations.
    (b) Required Use of Funds.--An award may be made under 
subsection (a) only if the applicant involved agrees that the 
grant will be expended--
            (1) to train members of minority health disparity 
        populations or other health disparity populations as 
        professionals in the area of biomedical or behavioral 
        research or both; or
            (2) to expand, remodel, renovate, or alter existing 
        research facilities or construct new research 
        facilities for the purpose of conducting minority 
        health disparities research and other health 
        disparities research.
    (c) Centers of Excellence.--
            (1) In general.--For purposes of this section, a 
        designated biomedical and behavioral research 
        institution is a biomedical and behavioral research 
        institution that--
                    (A) has a significant number of members of 
                minority health disparity populations or other 
                health disparity populations enrolled as 
                students in the institution (including 
                individuals accepted for enrollment in the 
                institution);
                    (B) has been effective in assisting such 
                students of the institution to complete the 
                program of education or training and receive 
                the degree involved;
                    (C) has made significant efforts to recruit 
                minority students to enroll in and graduate 
                from the institution, which may include 
                providing means-tested scholarships and other 
                financial assistance as appropriate; and
                    (D) has made significant recruitment 
                efforts to increase the number of minority or 
                other members of health disparity populations 
                serving in faculty or administrative positions 
                at the institution.
            (2) Consortium.--Any designated biomedical and 
        behavioral research institution involved may, with 
        other biomedical and behavioral institutions 
        (designated or otherwise), including tribal health 
        programs, form a consortium to receive an award under 
        subsection (a).
            (3) Application of criteria to other programs.--In 
        the case of any criteria established by the Director of 
        the Institute for purposes of determining whether 
        institutions meet the conditions described in paragraph 
        (1), this section may not, with respect to minority 
        health disparity populations or other health disparity 
        populations, be construed to authorize, require, or 
        prohibit the use of such criteria in any program other 
        than the program established in this section.
    (d) Duration of Grant.--The period during which payments 
are made under a grant under subsection (a) may not exceed 5 
years. Such payments shall be subject to annual approval by the 
Director of the Institute and to the availability of 
appropriations for the fiscal year involved to make the 
payments.
    (e) Maintenance of Effort.--
            (1) In general.--With respect to activities for 
        which an award under subsection (a) is authorized to be 
        expended, the Director of the Institute may not make 
        such an award to a designated research institution or 
        consortium for any fiscal year unless the institution, 
        or institutions in the consortium, as the case may be, 
        agree to maintain expenditures of non-Federal amounts 
        for such activities at a level that is not less than 
        the level of such expenditures maintained by the 
        institutions involved for the fiscal year preceding the 
        fiscal year for which such institutions receive such an 
        award.
            (2) Use of federal funds.--With respect to any 
        Federal amounts received by a designated research 
        institution or consortium and available for carrying 
        out activities for which an award under subsection (a) 
        is authorized to be expended, the Director of the 
        Institute may make such an award only if the 
        institutions involved agree that the institutions will, 
        before expending the award, expend the Federal amounts 
        obtained from sources other than the award.
    (f) Certain Expenditures.--The Director of the Institute 
may authorize a designated biomedical and behavioral research 
institution to expend a portion of an award under subsection 
(a) for research endowments.
    (g) Definitions.--For purposes of this section:
            (1) The term ``designated biomedical and behavioral 
        research institution'' has the meaning indicated for 
        such term in subsection (c)(1). Such term includes any 
        health professions school receiving an award of a grant 
        or contract under section 736.
            (2) The term ``program of excellence'' means any 
        program carried out by a designated biomedical and 
        behavioral research institution with an award under 
        subsection (a), if the program is for purposes for 
        which the institution involved is authorized in 
        subsection (b) to expend the grant.

SEC. 464Z-5.  [285T-2] LOAN REPAYMENT PROGRAM FOR MINORITY HEALTH 
                    DISPARITIES RESEARCH.

    (a) In General.--The Director of the Institute shall 
establish a program of entering into contracts with qualified 
health professionals under which such health professionals 
agree to engage in minority health disparities research or 
other health disparities research in consideration of the 
Federal Government agreeing to repay, for each year of engaging 
in such research, not more than $35,000 of the principal and 
interest of the educational loans of such health professionals.
    (b) Service Provisions.--The provisions of sections 338B, 
338C, and 338E shall, except as inconsistent with subsection 
(a), apply to the program established in such subsection to the 
same extent and in the same manner as such provisions apply to 
the National Health Service Corps Loan Repayment Program 
established in subpart III of part D of title III.
    (c) Requirement Regarding Health Disparity Populations.--
The Director of the Institute shall ensure that not fewer than 
50 percent of the contracts entered into under subsection (a) 
are for appropriately qualified health professionals who are 
members of a health disparity population.
    (d) Priority.--With respect to minority health disparities 
research and other health disparities research under subsection 
(a), the Secretary shall ensure that priority is given to 
conducting projects of biomedical research.

SEC. 464Z-6. [285T-3] GENERAL PROVISIONS REGARDING THE CENTER.

    The Secretary, acting through the Director of the National 
Institutes of Health, shall provide administrative support and 
support services to the Director of the Institute and shall 
ensure that such support takes maximum advantage of existing 
administrative structures at the agencies of the National 
Institutes of Health.

                  Part D--National Library of Medicine

                     Subpart 1--General Provisions

   purpose, establishment, and functions of the national library of 
                                medicine
    Sec. 465. [286] (a) In order to assist the advancement of 
medical and related sciences and to aid the dissemination and 
exchange of scientific and other information important to the 
progress of medicine and to the public health, there is 
established the National Library of Medicine (hereafter in this 
part referred to as the ``Library'').
    (b) The Secretary, through the Library and subject to 
subsection (d), shall--
            (1) acquire and preserve books, periodicals, 
        prints, films, recordings, and other library materials 
        pertinent to medicine;
            (2) organize the materials specified in paragraph 
        (1) by appropriate cataloging, indexing, and 
        bibliographical listings;
            (3) publish and disseminate the catalogs, indexes, 
        and bibliographies referred to in paragraph (2);
            (4) make available, through loans, photographic or 
        other copying procedures, or otherwise, such materials 
        in the Library as the Secretary determines appropriate;
            (5) provide reference and research assistance;
            (6) publicize the availability from the Library of 
        the products and services described in any of 
        paragraphs (1) through (5);
            (7) promote the use of computers and 
        telecommunications by health professionals (including 
        health professionals in rural areas) for the purpose of 
        improving access to biomedical information for health 
        care delivery and medical research; and
            (8) engage in such other activities as the 
        Secretary determines appropriate and as the Library's 
        resources permit.
    (c) The Secretary may exchange, destroy, or otherwise 
dispose of any books, periodicals, films, and other library 
materials not needed for the permanent use of the Library.
    (d)(1) The Secretary may, after obtaining the advice and 
recommendations of the Board of Regents, prescribe rules under 
which the Library will--
            (A) provide copies of its publications or 
        materials,
            (B) will make available its facilities for 
        research, or
            (C) will make available its bibliographic, 
        reference, or other services,
to public and private entities and individuals.
    (2) Rules prescribed under paragraph (1) may provide for 
making available such publications, materials, facilities, or 
services--
            (A) without charge as a public service,
            (B) upon a loan, exchange, or charge basis, or
            (C) in appropriate circumstances, under contract 
        arrangements made with a public or other nonprofit 
        entity.
    (e) Whenever the Secretary, with the advice of the Board of 
Regents, determines that--
            (1) in any geographic area of the United States 
        there is no regional medical library adequate to serve 
        such area;
            (2) under criteria prescribed for the 
        administration of section 475, there is a need for a 
        regional medical library to serve such area; and
            (3) because there is no medical library located in 
        such area which, with financial assistance under 
        section 475, can feasibly be developed into a regional 
        medical library adequate to serve such area,
the Secretary may establish, as a branch of the Library, a 
regional medical library to serve the needs of such area.
    (f) Section 231 shall be applicable to the acceptance and 
administration of gifts made for the benefit of the Library or 
for carrying out any of its functions, and the Board of Regents 
shall make recommendations to the Secretary relating to 
establishment within the Library of suitable memorials to the 
donors.
    (g) For purposes of this part, the terms ``medicine'' and 
``medical'', except when used in section 466, include 
preventive and therapeutic medicine, dentistry, pharmacy, 
hospitalization, nursing, public health, and the fundamental 
sciences related thereto, and other related fields of study, 
research, or activity.
                            board of regents
    Sec. 466. [286a] (a)(1)(A) The Board of Regents of the 
National Library of Medicine consists of ex officio members and 
ten members appointed by the Secretary.
    (B) The ex officio members are the Surgeons General of the 
Public Health Service, the Army, the Navy, and the Air Force, 
the Chief Medical Director of the Department of Veterans 
Affairs, the Dean of the Uniformed Services University of the 
Health Sciences, the Assistant Director for Biological, 
Behavioral, and Social Sciences of the National Science 
Foundation, the Director of the National Agricultural Library, 
and the Librarian of Congress (or their designees).
    (C) The appointed members shall be selected from among 
leaders in the various fields of the fundamental sciences, 
medicine, dentistry, public health, hospital administration, 
pharmacology, health communications technology, or scientific 
or medical library work, or in public affairs. At least six of 
the appointed members shall be selected from among leaders in 
the fields of medical, dental, or public health research or 
education.
    (2) The Board shall annually elect one of the appointed 
members to serve as chairman until the next election. The 
Secretary shall designate a member of the Library staff to act 
as executive secretary of the Board.
    (b) The Board shall advise, consult with, and make 
recommendations to the Secretary on matters of policy in regard 
to the Library, including such matters as the acquisition of 
materials for the Library, the scope, content, and organization 
of the Library's services, and the rules under which its 
materials, publications, facilities, and services shall be made 
available to various kinds of users. The Secretary shall 
include in the annual report of the Secretary to the Congress a 
statement covering the recommendations made by the Board and 
the disposition thereof. The Secretary may use the services of 
any member of the Board in connection with matters related to 
the work of the Library, for such periods, in addition to 
conference periods, as the Secretary may determine.
    (c) Each appointed member of the Board shall hold office 
for a term of four years, except that any member appointed to 
fill a vacancy occurring prior to the expiration of the term 
for which the predecessor of such member was appointed shall be 
appointed for the remainder of such term. None of the appointed 
members shall be eligible for reappointment within one year 
after the end of the preceding term of such member.
                           library facilities
    Sec. 467. [286a-1] The Administrator of General Services 
may acquire, by purchase, condemnation, donation, or otherwise, 
a suitable site or sites, selected by the Secretary in 
accordance with the direction of the Board, for suitable and 
adequate buildings and facilities for use of the Library and to 
erect thereon, furnish, and equip such buildings and 
facilities. Amounts appropriated to carry out this section may 
be used for the cost of preparation of drawings and 
specifications, supervision of construction, and other 
administrative expenses incident to the work. The Administrator 
of General Services shall prepare the plans and specifications, 
make all necessary contracts, and supervise construction.

                    Subpart 2--Financial Assistance

                              definitions
    Sec. 470. [286b-1] As used in this subpart--
            (1) the term ``medical library'' means a library 
        related to the sciences related to health; and
            (2) the term ``sciences related to health'' 
        includes medicine, osteopathy, dentistry, and public 
        health, and fundamental and applied sciences when 
        related thereto.
          national medical libraries assistance advisory board
    Sec. 471. [286b-2] (a) The Board of Regents of the National 
Library of Medicine shall also serve as the National Medical 
Libraries Assistance Advisory Board (hereafter in this subpart 
referred to as the ``Board'').
    (b) The Board shall advise and assist the Secretary in the 
preparation of general regulations and with respect to policy 
matters arising in the administration of this subpart.
    (c) The Secretary may use the services of any member of the 
Board, in connection with matters related to the administration 
of this part for such periods, in addition to conference 
periods, as the Secretary may determine.
    (d) Appointed members of the Board who are not otherwise in 
the employ of the United States, while attending conferences of 
the Board or otherwise serving at the request of the Secretary 
in connection with the administration of this subpart, shall be 
entitled to receive compensation, per diem in lieu of 
subsistence, and travel expenses in the same manner and under 
the same conditions as that prescribed under section 208(c) 
when attending conferences, traveling, or serving at the 
request of the Secretary in connection with the Board's 
function under this section.
            grants for training in medical library sciences
    Sec. 472. [286b-3] The Secretary shall make grants--
            (1) to individuals to enable them to accept 
        traineeships and fellowships leading to 
        postbaccalaureate academic degrees in the field of 
        medical library science, in related fields pertaining 
        to sciences related to health, or in the field of the 
        communication of information;
            (2) to individuals who are librarians or 
        specialists in information on sciences relating to 
        health, to enable them to undergo intensive training or 
        retraining so as to attain greater competence in their 
        occupations (including competence in the fields of 
        automatic data processing and retrieval);
            (3) to assist appropriate public and private 
        nonprofit institutions in developing, expanding, and 
        improving training programs in library science and the 
        field of communications of information pertaining to 
        sciences relating to health; and
            (4) to assist in the establishment of internship 
        programs in established medical libraries meeting 
        standards which the Secretary shall prescribe.
   assistance for special scientific projects, and for research and 
       development in medical library science and related fields
    Sec. 473. [286b-4] (a) The Secretary shall make grants to 
physicians and other practitioners in the sciences related to 
health, to scientists, and to public or nonprofit private 
institutions on behalf of such physicians, other practitioners, 
and scientists for the compilation of existing, or the writing 
of original, contributions relating to scientific, social, or 
cultural advancements in sciences related to health. In making 
such grants, the Secretary shall make appropriate arrangements 
under which the facilities of the Library and the facilities of 
libraries of public and private nonprofit institutions of 
higher learning may be made available in connection with the 
projects for which such grants are made.
    (b) The Secretary shall make grants to appropriate public 
or private nonprofit institutions and enter into contracts with 
appropriate persons, for purposes of carrying out projects of 
research, investigations, and demonstrations in the field of 
medical library science and related activities and for the 
development of new techniques, systems, and equipment, for 
processing, storing, retrieving, and distributing information 
pertaining to sciences related to health.
    (c)(1) The Secretary shall make grants to public or 
nonprofit private institutions for the purpose of carrying out 
projects of research on, and development and demonstration of, 
new education technologies.
    (2) The purposes for which a grant under paragraph (1) may 
be made include projects concerning--
            (A) computer-assisted teaching and testing of 
        clinical competence at health professions and research 
        institutions;
            (B) the effective transfer of new information from 
        research laboratories to appropriate clinical 
        applications;
            (C) the expansion of the laboratory and clinical 
        uses of computer-stored research databases; and
            (D) the testing of new technologies for training 
        health care professionals.
    (3) The Secretary may not make a grant under paragraph (1) 
unless the applicant for the grant agrees to make the projects 
available with respect to--
            (A) assisting in the training of health professions 
        students; and
            (B) enhancing and improving the capabilities of 
        health professionals regarding research and teaching.
 grants for establishing, expanding, and improving the basic resources 
           of medical libraries and related instrumentalities
    Sec. 474. [286b-5] (a) The Secretary shall make grants of 
money, materials, or both, to public or private nonprofit 
medical libraries and related scientific communication 
instrumentalities for the purpose of establishing, expanding, 
and improving their basic medical library or related resources. 
A grant under this subsection may be used for--
            (1) the acquisition of books, journals, 
        photographs, motion picture and other films, and other 
        similar materials;
            (2) cataloging, binding, and other services and 
        procedures for processing library resource materials 
        for use by those who are served by the library or 
        related instrumentality;
            (3) the acquisition of duplication devices, 
        facsimile equipment, film projectors, recording 
        equipment, and other equipment to facilitate the use of 
        the resources of the library or related instrumentality 
        by those who are served by it; and
            (4) the introduction of new technologies in medical 
        librarianship.
    (b)(1) The amount of any grant under this section to any 
medical library or related instrumentality shall be determined 
by the Secretary on the basis of the scope of library or 
related services provided by such library or instrumentality in 
relation to the population and purposes served by it. In making 
a determination of the scope of services served by any medical 
library or related instrumentality, the Secretary shall take 
into account--
            (A) the number of graduate and undergraduate 
        students making use of the resources of such library or 
        instrumentality;
            (B) the number of physicians and other 
        practitioners in the sciences related to health 
        utilizing the resources of such library or 
        instrumentality;
            (C) the type of supportive staffs, if any, 
        available to such library or instrumentality;
            (D) the type, size, and qualifications of the 
        faculty of any school with which such library or 
        instrumentality is affiliated;
            (E) the staff of any hospital or hospitals or of 
        any clinic or clinics with which such library or 
        instrumentality is affiliated; and
            (F) the geographic area served by such library or 
        instrumentality and the availability within such area 
        of medical library or related services provided by 
        other libraries or related instrumentalities.
    (2) Grants to such medical libraries or related 
instrumentalities under this section shall be in such amounts 
as the Secretary may by regulation prescribe with a view to 
assuring adequate continuing financial support for such 
libraries or instrumentalities from other sources during and 
after the period for which grants are provided, except that in 
no case shall any grant under this section to a medical library 
or related instrumentality for any fiscal year exceed 
$1,000,000.
  grants and contracts for establishment of regional medical libraries
    Sec. 475. [286b-6] (a) The Secretary, with the advice of 
the Board, shall make grants to and enter into contracts with 
existing public or private nonprofit medical libraries so as to 
enable each of them to serve as the regional medical library 
for the geographical area in which it is located.
    (b) The uses for which grants and contracts under this 
section may be employed include the--
            (1) acquisition of books, journals, and other 
        similar materials;
            (2) cataloging, binding, and other procedures for 
        processing library resource materials for use by those 
        who are served by the library;
            (3) acquisition of duplicating devices and other 
        equipment to facilitate the use of the resources of the 
        library by those who are served by it;
            (4) acquisition of mechanisms and employment of 
        personnel for the speedy transmission of materials from 
        the regional library to local libraries in the 
        geographic area served by the regional library; and
            (5) planning for services and activities under this 
        section.
    (c)(1) Grants and contracts under this section shall only 
be made to or entered into with medical libraries which agree--
            (A) to modify and increase their library resources, 
        and to supplement the resources of cooperating 
        libraries in the region, so as to be able to provide 
        adequate supportive services to all libraries in the 
        region as well as to individual users of library 
        services; and
            (B) to provide free loan services to qualified 
        users and make available photoduplicated or facsimile 
        copies of biomedical materials which qualified 
        requesters may retain.
    (2) The Secretary, in awarding grants and contracts under 
this section, shall give priority to medical libraries having 
the greatest potential of fulfilling the needs for regional 
medical libraries. In determining the priority to be assigned 
to any medical library, the Secretary shall consider--
            (A) the adequacy of the library (in terms of 
        collections, personnel, equipment, and other 
        facilities) as a basis for a regional medical library; 
        and
            (B) the size and nature of the population to be 
        served in the region in which the library is located.
    (d) Grants and contracts under this section for basic 
resource materials to a library may not exceed--
            (1) 50 percent of the library's annual operating 
        expense (exclusive of Federal financial assistance 
        under this part) for the preceding year; or
            (2) in case of the first year in which the library 
        receives a grant under this section for basic resource 
        materials, 50 percent of its average annual operating 
        expenses over the past three years (or if it had been 
        in operation for less than three years, its annual 
        operating expenses determined by the Secretary in 
        accordance with regulations).
        financial support of biomedical scientific publications
    Sec. 476. [286b-7] (a) The Secretary, with the advice of 
the Board, shall make grants to, and enter into appropriate 
contracts with, public or private nonprofit institutions of 
higher education and individual scientists for the purpose of 
supporting biomedical scientific publications of a nonprofit 
nature and to procure the compilation, writing, editing, and 
publication of reviews, abstracts, indices, handbooks, 
bibliographies, and related matter pertaining to scientific 
works and scientific developments.
    (b) Grants under subsection (a) in support of any single 
periodical publication may not be made for more than three 
years, except in those cases in which the Secretary determines 
that further support is necessary to carry out the purposes of 
subsection (a).
                   grant payments, records, and audit
    Sec. 477. [286b-8] (a) Payments under grants made under 
sections 472, 473, 474, 475, and 476 may be made in advance or 
by way of reimbursement and in such installments as the 
Secretary shall prescribe by regulation after consultation with 
the Board.
    (b)(1) Each recipient of a grant under this subpart shall 
keep such records as the Secretary shall prescribe, including 
records which fully disclose the amount and disposition by such 
recipient of the proceeds of such grant, the total cost of the 
project or undertaking in connection with which such grant is 
given or used, and the amount of that portion of the cost of 
the project or undertaking supplied by other sources, and such 
other records as will facilitate an effective audit.
    (2) The Secretary and the Comptroller General of the United 
States, or any of their duly authorized representatives, shall 
have access for the purpose of audit and examination to any 
books, documents, papers, and records of such recipients that 
are pertinent to any grant received under this subpart.

     H5  deg.Subpart 3--National Center for Biotechnology 
                              Information

 h3  deg.purpose, establishment, functions, and funding of the 
             national center for biotechnology information
    Sec. 478. [286c] (a) In order to focus and expand the 
collection, storage, retrieval, and dissemination of the 
results of biotechnology research by information systems, and 
to support and enhance the development of new information 
technologies to aid in the understanding of the molecular 
processes that control health and disease, there is established 
the National Center for Biotechnology Information (hereinafter 
in this section referred to as the ``Center'') in the National 
Library of Medicine.
    (b) The Secretary, through the Center and subject to 
section 465(d), shall--
            (1) design, develop, implement, and manage 
        automated systems for the collection, storage, 
        retrieval, analysis, and dissemination of knowledge 
        concerning human molecular biology, biochemistry, and 
        genetics;
            (2) perform research into advanced methods of 
        computer-based information processing capable of 
        representing and analyzing the vast number of 
        biologically important molecules and compounds;
            (3) enable persons engaged in biotechnology 
        research and medical care to use systems developed 
        under paragraph (1) and methods described in paragraph 
        (2); and
            (4) coordinate, as much as is practicable, efforts 
        to gather biotechnology information on an international 
        basis.

   H2  deg.Subpart 4--National Information Center on Health 
              Services Research and Health Care Technology

              h3  deg.national information center
    Sec. 478A. [286d] (a) There is established within the 
Library an entity to be known as the National Information 
Center on Health Services Research and Health Care Technology 
(in this section referred to as the ``Center'').
    (b) The purpose of the Center is the collection, storage, 
analysis, retrieval, and dissemination of information on health 
services research, clinical practice guidelines, and on health 
care technology, including the assessment of such technology. 
Such purpose includes developing and maintaining data bases and 
developing and implementing methods of carrying out such 
purpose.
    (c) The Director of the Center shall ensure that 
information under subsection (b) concerning clinical practice 
guidelines is collected and maintained electronically and in a 
convenient format. Such Director shall develop and publish 
criteria for the inclusion of practice guidelines and 
technology assessments in the information center database.
    (d) The Secretary, acting through the Center, shall 
coordinate the activities carried out under this section 
through the Center with related activities of the Administrator 
for Health Care Policy and Research.

                     Part E--Other Agencies of NIH

           Subpart 1--National Center for Research Resources

                            general purpose
    Sec. 479. [287] The general purpose of the National Center 
for Research Resources (in this subpart referred to as the 
``Center'') is to strengthen and enhance the research 
environments of entities engaged in health-related research by 
developing and supporting essential research resources.
                            advisory council
    Sec. 480. [287a] (a)(1) The Secretary shall appoint an 
advisory council for the Center which shall advise, assist, 
consult with, and make recommendations to the Secretary and the 
Director of the Center on matters related to the activities 
carried out by and through the Center and the policies 
respecting such activities.
    (2) The advisory council for the Center may recommend to 
the Secretary acceptance, in accordance with section 231, of 
conditional gifts for study, investigations, and research and 
for the acquisition of grounds or construction, equipping, or 
maintenance of facilities for the Center.
    (3) The advisory council for the Center--
            (A)(i) may make recommendations to the Director of 
        the Center respecting research conducted at the Center,
            (ii) may review applications for grants and 
        cooperative agreements for research or training and 
        recommend for approval applications for projects which 
        show promise of making valuable contributions to human 
        knowledge, and
            (iii) may review any grant, contract, or 
        cooperative agreement proposed to be made or entered 
        into by the Center;
            (B) may collect, by correspondence or by personal 
        investigation, information as to studies which are 
        being carried on in the United States or any other 
        country as to the diseases, disorders, or other aspects 
        of human health with respect to which the Center is 
        concerned and with the approval of the Director of the 
        Center make available such information through 
        appropriate publications for the benefit of public and 
        private health entities and health professions 
        personnel and scientists and for the information of the 
        general public; and
            (C) may appoint subcommittees and convene workshops 
        and conferences.
    (b)(1) The advisory council shall consist of ex officio 
members and not more than eighteen members appointed by the 
Secretary.
    (2) The ex officio members of the advisory council shall 
consist of--
            (A) the Secretary, the Director of NIH, the 
        Director of the Center, the Chief Medical Director of 
        the Department of Veterans Affairs, and the Assistant 
        Secretary of Defense for Health Affairs (or the 
        designees of such officers), and
            (B) such additional officers or employees of the 
        United States as the Secretary determines necessary for 
        the advisory council to effectively carry out its 
        functions.
    (3) The members of the advisory council who are not ex 
officio members shall be appointed as follows:
            (A) Two-thirds of the members shall be appointed by 
        the Secretary from among the leading representatives of 
        the health and scientific disciplines (including public 
        health and the behavioral or social sciences) relevant 
        to the activities of the Center.
            (B) One-third of the members shall be appointed by 
        the Secretary from the general public and shall include 
        leaders in fields of public policy, law, health policy, 
        economics, and management.
    (4) Members of the advisory council who are officers or 
employees of the United States shall not receive any 
compensation for service on the advisory council. The other 
members of the advisory council shall receive, for each day 
(including traveltime) they are engaged in the performance of 
the functions of the advisory council, compensation at rates 
not to exceed the daily equivalent of the annual rate in effect 
for grade GS-18 of the General Schedule.
    (c) The term of office of an appointed member of the 
advisory council is four years, except that any member 
appointed to fill a vacancy for an unexpired term shall be 
appointed for the remainder of such term and the Secretary 
shall make appointments to an advisory council in such a manner 
as to ensure that the terms of the members do not all expire in 
the same year. A member may serve after the expiration of the 
member's term until a successor has taken office. A member who 
has been appointed for a term of four years may not be 
reappointed to an advisory council before two years from the 
date of expiration of such term of office. If a vacancy occurs 
in the advisory council among the appointed members, the 
Secretary shall make an appointment to fill the vacancy within 
90 days from the date the vacancy occurs.
    (d) The chairman of the advisory council shall be selected 
by the Secretary from among the appointed members, except that 
the Secretary may select the Director of the Center to be the 
chairman of the advisory council. The term of office of the 
chairman shall be two years.
    (e) The advisory council shall meet at the call of the 
chairman or upon the request of the Director of the Center, but 
at least three times each fiscal year. The location of the 
meetings of the advisory council is subject to the approval of 
the Director of the Center.
    (f) The Director of the Center shall designate a member of 
the staff of the Center to serve as the executive secretary of 
the advisory council. The Director of the Center shall make 
available to the advisory council such staff, information, and 
other assistance as it may require to carry out its functions. 
The Director of the Center shall provide orientation and 
training for new members of the advisory council to provide 
them with such information and training as may be appropriate 
for their effective participation in the functions of the 
advisory council.
    (g) The advisory council may prepare, for inclusion in the 
biennial report made under section 481, (1) comments respecting 
the activities of the advisory council in the fiscal years 
respecting which the report is prepared, (2) comments on the 
progress of the Center in meeting its objectives, and (3) 
recommendations respecting the future directions and program 
and policy emphasis of the Center. The advisory council may 
prepare such additional reports as it may determine 
appropriate.
    (h) This section does not terminate the membership of the 
advisory council for the Center which was in existence on the 
date of enactment of the Health Research Extension Act of 1985. 
After such date--
            (1) the Secretary shall make appointments to such 
        advisory council in such a manner as to bring about as 
        soon as practicable the composition for such council 
        prescribed by this section;
            (2) the advisory council shall organize itself in 
        accordance with this section and exercise the functions 
        prescribed by this section; and
            (3) the Director of the Center shall perform for 
        such advisory council the functions prescribed by this 
        section.
                            biennial report
    Sec. 481. [287a-1] The Director of the Center, after 
consultation with the advisory council for the Center, shall 
prepare for inclusion in the biennial report made under section 
403 a biennial report which shall consist of a description of 
the activities of the Center and program policies of the 
Director of the Center in the fiscal years respecting which the 
report is prepared. The Director of the Center may prepare such 
additional reports as the Director determines appropriate. The 
Director of the Center shall provide the advisory council of 
the Center an opportunity for the submission of the written 
comments referred to in section 480(g).

SEC. 481A. [287A-2] BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES.

    (a) Modernization and Construction of Facilities.--
            (1) In general.--The Director of NIH, acting 
        through the Director of the Center or the Director of 
        the National Institute of Allergy and Infectious 
        Diseases, may make grants or contracts to public and 
        nonprofit private entities to expand, remodel, 
        renovate, or alter existing research facilities or 
        construct new research facilities, subject to the 
        provisions of this section.
            (2) Construction and cost of construction.--For 
        purposes of this section, the terms ``construction'' 
        and ``cost of construction'' include the construction 
        of new buildings and the expansion, renovation, 
        remodeling, and alteration of existing buildings, 
        including architects' fees, but do not include the cost 
        of acquisition of land or off-site improvements.
    (b) Scientific and Technical Review Boards for Merit-Based 
Review of Proposals.--
            (1) In general: approval as precondition to 
        grants.--
                    (A) Establishment.--There is established 
                within the Center a Scientific and Technical 
                Review Board on Biomedical and Behavioral 
                Research Facilities (referred to in this 
                section as the ``Board'').
                    (B) Requirement.--The Director of the 
                Center may approve an application for a grant 
                under subsection (a) only if the Board has 
                under paragraph (2) recommended the application 
                for approval.
            (2) Duties.--
                    (A) Advice.--The Board shall provide advice 
                to the Director of the Center and the advisory 
                council established under section 480 (in this 
                section referred to as the ``Advisory 
                Council'') in carrying out this section.
                    (B) Determination of merit.--In carrying 
                out subparagraph (A), the Board shall make a 
                determination of the merit of each application 
                submitted for a grant under subsection (a), 
                after consideration of the requirements 
                established in subsection (c), and shall report 
                the results of the determination to the 
                Director of the Center and the Advisory 
                Council. Such determinations shall be conducted 
                in a manner consistent with procedures 
                established under section 492.
                    (C) Amount.--In carrying out subparagraph 
                (A), the Board shall, in the case of 
                applications recommended for approval, make 
                recommendations to the Director and the 
                Advisory Council on the amount that should be 
                provided under the grant.
                    (D) Annual report.--In carrying out 
                subparagraph (A), the Board shall prepare an 
                annual report for the Director of the Center 
                and the Advisory Council describing the 
                activities of the Board in the fiscal year for 
                which the report is made. Each such report 
                shall be available to the public, and shall--
                            (i) summarize and analyze 
                        expenditures made under this section;
                            (ii) provide a summary of the 
                        types, numbers, and amounts of 
                        applications that were recommended for 
                        grants under subsection (a) but that 
                        were not approved by the Director of 
                        the Center; and
                            (iii) contain the recommendations 
                        of the Board for any changes in the 
                        administration of this section.
            (3) Membership.--
                    (A) In general.--Subject to subparagraph 
                (B), the Board shall be composed of 15 members 
                to be appointed by the Director of the Center, 
                and such ad-hoc or temporary members as the 
                Director of the Center determines to be 
                appropriate. All members of the Board, 
                including temporary and ad-hoc members, shall 
                be voting members.
                    (B) Limitation.--Not more than three 
                individuals who are officers or employees of 
                the Federal Government may serve as members of 
                the Board.
            (4) Certain requirements regarding membership.--In 
        selecting individuals for membership on the Board, the 
        Director of the Center shall ensure that the members 
        are individuals who, by virtue of their training or 
        experience, are eminently qualified to perform peer 
        review functions. In selecting such individuals for 
        such membership, the Director of the Center shall 
        ensure that the members of the Board collectively--
                    (A) are experienced in the planning, 
                construction, financing, and administration of 
                entities that conduct biomedical or behavioral 
                research sciences;
                    (B) are knowledgeable in making 
                determinations of the need of entities for 
                biomedical or behavioral research facilities, 
                including such facilities for the dentistry, 
                nursing, pharmacy, and allied health 
                professions;
                    (C) are knowledgeable in evaluating the 
                relative priorities for applications for grants 
                under subsection (a) in view of the overall 
                research needs of the United States; and
                    (D) are experienced with emerging centers 
                of excellence, as described in subsection 
                (c)(2).
            (5) Certain authorities.--
                    (A) Workshops and conferences.--In carrying 
                out paragraph (2), the Board may convene 
                workshops and conferences, and collect data as 
                the Board considers appropriate.
                    (B) Subcommittees.--In carrying out 
                paragraph (2), the Board may establish 
                subcommittees within the Board. Such 
                subcommittees may hold meetings as determined 
                necessary to enable the subcommittee to carry 
                out its duties.
            (6) Terms.--
                    (A) In general.--Except as provided in 
                subparagraph (B), each appointed member of the 
                Board shall hold office for a term of 4 years. 
                Any member appointed to fill a vacancy 
                occurring prior to the expiration of the term 
                for which such member's predecessor was 
                appointed shall be appointed for the remainder 
                of the term of the predecessor.
                    (B) Staggered terms.--Members appointed to 
                the Board shall serve staggered terms as 
                specified by the Director of the Center when 
                making the appointments.
                    (C) Reappointment.--No member of the Board 
                shall be eligible for reappointment to the 
                Board until 1 year has elapsed after the end of 
                the most recent term of the member.
            (7) Compensation.--Members of the Board who are not 
        officers or employees of the United States shall 
        receive for each day the members are engaged in the 
        performance of the functions of the Board compensation 
        at the same rate received by members of other national 
        advisory councils established under this title.
    (c) Requirements for Grants.--
            (1) In general.--The Director of the Center or the 
        Director of the National Institute of Allergy and 
        Infectious Diseases may make a grant under subsection 
        (a) only if the applicant for the grant meets the 
        following conditions:
                    (A) The applicant is determined by such 
                Director to be competent to engage in the type 
                of research for which the proposed facility is 
                to be constructed.
                    (B) The applicant provides assurances 
                satisfactory to the Director that--
                            (i) for not less than 20 years 
                        after completion of the construction 
                        involved, the facility will be used for 
                        the purposes of the research for which 
                        it is to be constructed;
                            (ii) sufficient funds will be 
                        available to meet the non-Federal share 
                        of the cost of constructing the 
                        facility;
                            (iii) sufficient funds will be 
                        available, when construction is 
                        completed, for the effective use of the 
                        facility for the research for which it 
                        is being constructed; and
                            (iv) the proposed construction will 
                        expand the applicant's capacity for 
                        research, or is necessary to improve or 
                        maintain the quality of the applicant's 
                        research.
                    (C) The applicant meets reasonable 
                qualifications established by the Director with 
                respect to--
                            (i) the relative scientific and 
                        technical merit of the applications, 
                        and the relative effectiveness of the 
                        proposed facilities, in expanding the 
                        capacity for biomedical or behavioral 
                        research and in improving the quality 
                        of such research;
                            (ii) the quality of the research or 
                        training, or both, to be carried out in 
                        the facilities involved;
                            (iii) the congruence of the 
                        research activities to be carried out 
                        within the facility with the research 
                        and investigator manpower needs of the 
                        United States; and
                            (iv) the age and condition of 
                        existing research facilities.
                    (D) The applicant has demonstrated a 
                commitment to enhancing and expanding the 
                research productivity of the applicant.
            (2) Institutions of emerging excellence.--From the 
        amount appropriated to carry out this section for a 
        fiscal year up to $50,000,000, the Director of the 
        Center shall make available 25 percent of such amount, 
        and from the amount appropriated to carry out this 
        section for a fiscal year that is over $50,000,000, the 
        Director of the Center shall make available up to 25 
        percent of such amount, for grants under subsection (a) 
        to applicants that in addition to meeting the 
        requirements established in paragraph (1), have 
        demonstrated emerging excellence in biomedical or 
        behavioral research, as follows:
                    (A) The applicant has a plan for research 
                or training advancement and possesses the 
                ability to carry out the plan.
                    (B) The applicant carries out research and 
                research training programs that have a special 
                relevance to a problem, concern, or unmet 
                health need of the United States.
                    (C) The applicant has been productive in 
                research or research development and training.
                    (D) The applicant--
                            (i) has been designated as a center 
                        of excellence under section 739;
                            (ii) is located in a geographic 
                        area whose population includes a 
                        significant number of individuals with 
                        health status deficit, and the 
                        applicant provides health services to 
                        such individuals; or
                            (iii) is located in a geographic 
                        area in which a deficit in health care 
                        technology, services, or research 
                        resources may adversely affect the 
                        health status of the population of the 
                        area in the future, and the applicant 
                        is carrying out activities with respect 
                        to protecting the health status of such 
                        population.
    (d) Requirement of Application.--The Director of the Center 
or the Director of the National Institute of Allergy and 
Infectious Diseases may make a grant under subsection (a) only 
if an application for the grant is submitted to the Director 
and the application is in such form, is made in such manner, 
and contains such agreements, assurances, and information as 
the Director determines to be necessary to carry out this 
section.
    (e) Amount of Grant; Payments.--
            (1) Amount.--The amount of any grant awarded under 
        subsection (a) shall be determined by the Director of 
        the Center or the Director of the National Institute of 
        Allergy and Infectious Diseases, except that such 
        amount shall not exceed--
                    (A) 50 percent (or, in the case of the 
                Institute, 75 percent) of the necessary cost of 
                the construction of a proposed facility as 
                determined by the Director; or
                    (B) in the case of a multipurpose facility, 
                40 percent (or, in the case of the Institute, 
                75 percent) of that part of the necessary cost 
                of construction that the Director determines to 
                be proportionate to the contemplated use of the 
                facility.
            (2) Reservation of amounts.--On the approval of any 
        application for a grant under subsection (a), the 
        Director of the Center or the Director of the National 
        Institute of Allergy and Infectious Diseases shall 
        reserve, from any appropriation available for such 
        grants, the amount of such grant, and shall pay such 
        amount, in advance or by way of reimbursement, and in 
        such installments consistent with the construction 
        progress, as the Director may determine appropriate. 
        The reservation of any amount by the Director under 
        this paragraph may be amended by the Director, either 
        on the approval of an amendment of the application or 
        on the revision of the estimated cost of construction 
        of the facility.
            (3) Exclusion of certain costs.--In determining the 
        amount of any grant under subsection (a), there shall 
        be excluded from the cost of construction an amount 
        equal to the sum of--
                    (A) the amount of any other Federal grant 
                that the applicant has obtained, or is assured 
                of obtaining, with respect to construction that 
                is to be financed in part by a grant authorized 
                under this section; and
                    (B) the amount of any non-Federal funds 
                required to be expended as a condition of such 
                other Federal grant.
            (4) Waiver of limitations.--The limitations imposed 
        under paragraph (1) may be waived at the discretion of 
        the Director of the Center or the Director of the 
        National Institute of Allergy and Infectious Diseases 
        for applicants meeting the conditions described in 
        subsection (c).
    (f ) Recapture of Payments.--If, not later than 20 years 
after the completion of construction for which a grant has been 
awarded under subsection (a)--
            (1) in the case of an award by the Director of the 
        Center, the applicant or other owner of the facility 
        shall cease to be a public or non profit private 
        entity; or
            (2) the facility shall cease to be used for the 
        research purposes for which it was constructed (unless 
        the Director of the Center or the Director of the 
        National Institute of Allergy and Infectious Diseases 
        determines, in accordance with regulations, that there 
        is good cause for releasing the applicant or other 
        owner from obligation to do so),
the United States shall be entitled to recover from the 
applicant or other owner of the facility the amount bearing the 
same ratio to the current value (as determined by an agreement 
between the parties or by action brought in the United States 
District Court for the district in which such facility is 
situated) of the facility as the amount of the Federal 
participation bore to the cost of the construction of such 
facility.
    (g) Guidelines.--Not later than 6 months after the date of 
the enactment of this section, the Director of the Center, 
after consultation with the Advisory Council, shall issue 
guidelines with respect to grants under subsection (a).
       construction of regional centers for research on primates
    Sec. 481B. [287a-3] (a) With respect to activities carried 
out by the National Center for Research Resources to support 
regional centers for research on primates, the Director of NIH 
may, for each of the fiscal years 1994 through 1996 \1\, 
reserve from the amounts appropriated to carry out section 481A 
up to $2,500,000 for the purpose of making awards of grants and 
contracts to public or nonprofit private entities to construct, 
renovate, or otherwise improve such regional centers. The 
reservation of such amounts for any fiscal year is subject to 
the availability of qualified applicants for such awards.
---------------------------------------------------------------------------
    \1\ The probable intent of the Congress is that the authorization 
of appropriations be for fiscals year 2000 through 2002. Section 304 of 
Public Law 106-505 (114 Stat. 2335) provided that section 481B(a) ``is 
amended by striking `1994' and all that follows through `$5,000,000' 
and inserting `2000 through 2002, reserve from the amounts appropriated 
under section 481A(i) such sums as necessary'''. The amendment cannot 
be executed because a term referenced in the instructions, 
``$5,000,000'', does not appear in section 481B(a). The term 
``2,500,000'' probably should have been referenced.
---------------------------------------------------------------------------
    (b) The Director of NIH may not make a grant or enter into 
a contract under subsection (a) unless the applicant for such 
assistance agrees, with respect to the costs to be incurred by 
the applicant in carrying out the purpose described in such 
subsection, to make available (directly or through donations 
from public or private entities) non-Federal contributions in 
cash toward such costs in an amount equal to not less than $1 
for each $4 of Federal funds provided in such assistance.

SEC. 481C. [287A-3A] SANCTUARY SYSTEM FOR SURPLUS CHIMPANZEES.

    (a) In General.--The Secretary shall provide for the 
establishment and operation in accordance with this section of 
a system to provide for the lifetime care of chimpanzees that 
have been used, or were bred or purchased for use, in research 
conducted or supported by the National Institutes of Health, 
the Food and Drug Administration, or other agencies of the 
Federal Government, and with respect to which it has been 
determined by the Secretary that the chimpanzees are not needed 
for such research (in this section referred to as ``surplus 
chimpanzees'').
    (b) Administration of Sanctuary System.--The Secretary 
shall carry out this section, including the establishment of 
regulations under subsection (d), in consultation with the 
board of directors of the nonprofit private entity that 
receives the contract under subsection (e) (relating to the 
operation of the sanctuary system).
    (c) Acceptance of Chimpanzees Into System.--All surplus 
chimpanzees owned by the Federal Government shall be accepted 
into the sanctuary system. Subject to standards under 
subsection (d)(4), any chimpanzee that is not owned by the 
Federal Government can be accepted into the system if the owner 
transfers to the sanctuary system title to the chimpanzee.
    (d) Standards for Permanent Retirement of Surplus 
Chimpanzees.--
            (1) In general.--Not later than 180 days after the 
        date of the enactment of this section, the Secretary 
        shall by regulation establish standards for operating 
        the sanctuary system to provide for the permanent 
        retirement of surplus chimpanzees. In establishing the 
        standards, the Secretary shall consider the 
        recommendations of the board of directors of the 
        nonprofit private entity that receives the contract 
        under subsection (e), and shall consider the 
        recommendations of the National Research Council 
        applicable to surplus chimpanzees that are made in the 
        report published in 1997 and entitled ``Chimpanzees in 
        Research--Strategies for Their Ethical Care, 
        Management, and Use''.
            (2) Chimpanzees accepted into system.--With respect 
        to chimpanzees that are accepted into the sanctuary 
        system, standards under paragraph (1) shall include the 
        following:
                    (A) A prohibition that the chimpanzees may 
                not be used for research, except as authorized 
                under paragraph (3).
                    (B) Provisions regarding the housing of the 
                chimpanzees.
                    (C) Provisions regarding the behavioral 
                well-being of the chimpanzees.
                    (D) A requirement that the chimpanzees be 
                cared for in accordance with the Animal Welfare 
                Act.
                    (E) A requirement that the chimpanzees be 
                prevented from breeding.
                    (F) A requirement that complete histories 
                be maintained on the health and use in research 
                of the chimpanzees.
                    (G) A requirement that the chimpanzees be 
                monitored for the purpose of promptly detecting 
                the presence in the chimpanzees of any 
                condition that may be a threat to the public 
                health or the health of other chimpanzees.
                    (H) A requirement that chimpanzees posing 
                such a threat be contained in accordance with 
                applicable recommendations of the Director of 
                the Centers for Disease Control and Prevention.
                    (I) A prohibition that none of the 
                chimpanzees may be subjected to euthanasia, 
                except as in the best interests of the 
                chimpanzee involved, as determined by the 
                system and an attending veterinarian.
                    (J) A prohibition that the chimpanzees may 
                not be discharged from the system.
                    (K) A provision that the Secretary may, in 
                the discretion of the Secretary, accept into 
                the system chimpanzees that are not surplus 
                chimpanzees.
                    (L) Such additional standards as the 
                Secretary determines to be appropriate.
            (3) Restrictions regarding research.--
                    (A) In general.--For purposes of paragraph 
                (2)(A), standards under paragraph (1) shall 
                provide that a chimpanzee accepted into the 
                sanctuary system may not be used for studies or 
                research, except that the chimpanzee may be 
                used for noninvasive behavioral studies or 
                medical studies based on information collected 
                during the course of normal veterinary care 
                that is provided for the benefit of the 
                chimpanzee, provided that any such study 
                involves minimal physical and mental harm, 
                pain, distress, and disturbance to the 
                chimpanzee and the social group in which the 
                chimpanzee lives.
                    (B) Additional restriction.--For purposes 
                of paragraph (2)(A), a condition for the use in 
                studies or research of a chimpanzee accepted 
                into the sanctuary system is (in addition to 
                conditions under subparagraph (A) of this 
                paragraph) that the applicant for such use has 
                not been fined for, or signed a consent decree 
                for, any violation of the Animal Welfare Act.
            (4) Non-federal chimpanzees offered for acceptance 
        into system.--With respect to a chimpanzee that is not 
        owned by the Federal Government and is offered for 
        acceptance into the sanctuary system, standards under 
        paragraph (1) shall include the following:
                    (A) A provision that the Secretary may 
                authorize the imposition of a fee for accepting 
                such chimpanzee into the system, except as 
                follows:
                            (i) Such a fee may not be imposed 
                        for accepting the chimpanzee if, on the 
                        day before the date of the enactment of 
                        this section, the chimpanzee was owned 
                        by the nonprofit private entity that 
                        receives the contract under subsection 
                        (e) or by any individual sanctuary 
                        facility receiving a subcontract or 
                        grant under subsection (e)(1).
                            (ii) Such a fee may not be imposed 
                        for accepting the chimpanzee if the 
                        chimpanzee is owned by an entity that 
                        operates a primate center, and if the 
                        chimpanzee is housed in the primate 
                        center pursuant to the program for 
                        regional centers for research on 
                        primates that is carried out by the 
                        National Center for Research Resources.
                Any fees collected under this subparagraph are 
                available to the Secretary for the costs of 
                operating the system. Any other fees received 
                by the Secretary for the long-term care of 
                chimpanzees (including any Federal fees that 
                are collected for such purpose and are 
                identified in the report under section 3 of the 
                Chimpanzee Health Improvement, Maintenance, and 
                Protection Act) are available for operating the 
                system, in addition to availability for such 
                other purposes as may be authorized for the use 
                of the fees.
                    (B) A provision that the Secretary may deny 
                such chimpanzee acceptance into the system if 
                the capacity of the system is not sufficient to 
                accept the chimpanzee, taking into account the 
                physical capacity of the system; the financial 
                resources of the system; the number of 
                individuals serving as the staff of the system, 
                including the number of professional staff; the 
                necessity of providing for the safety of the 
                staff and of the public; the necessity of 
                caring for accepted chimpanzees in accordance 
                with the standards under paragraph (1); and 
                such other factors as may be appropriate.
                    (C) A provision that the Secretary may deny 
                such chimpanzee acceptance into the system if a 
                complete history of the health and use in 
                research of the chimpanzee is not available to 
                the Secretary.
                    (D) Such additional standards as the 
                Secretary determines to be appropriate.
    (e) Award of Contract for Operation of System.--
            (1) In general.--Subject to the availability of 
        funds pursuant to subsection (g), the Secretary shall 
        make an award of a contract to a nonprofit private 
        entity under which the entity has the responsibility of 
        operating (and establishing, as applicable) the 
        sanctuary system and awarding subcontracts or grants to 
        individual sanctuary facilities that meet the standards 
        under subsection (d).
            (2) Requirements.--The Secretary may make an award 
        under paragraph (1) to a nonprofit private entity only 
        if the entity meets the following requirements:
                    (A) The entity has a governing board of 
                directors that is composed and appointed in 
                accordance with paragraph (3) and is 
                satisfactory to the Secretary.
                    (B) The terms of service for members of 
                such board are in accordance with paragraph 
                (3).
                    (C) The members of the board serve without 
                compensation. The members may be reimbursed for 
                travel, subsistence, and other necessary 
                expenses incurred in carrying out the duties of 
                the board.
                    (D) The entity has an executive director 
                meeting such requirements as the Secretary 
                determines to be appropriate.
                    (E) The entity makes the agreement 
                described in paragraph (4) (relating to non-
                Federal contributions).
                    (F) The entity agrees to comply with 
                standards under subsection (d).
                    (G) The entity agrees to make necropsy 
                reports on chimpanzees in the sanctuary system 
                available on a reasonable basis to persons who 
                conduct biomedical or behavioral research, with 
                priority given to such persons who are Federal 
                employees or who receive financial support from 
                the Federal Government for research.
                    (H) Such other requirements as the 
                Secretary determines to be appropriate.
            (3) Board of directors.--For purposes of 
        subparagraphs (A) and (B) of paragraph (2):
                    (A) The governing board of directors of the 
                nonprofit private entity involved is composed 
                and appointed in accordance with this paragraph 
                if the following conditions are met:
                            (i) Such board is composed of not 
                        more than 13 voting members.
                            (ii) Such members include 
                        individuals with expertise and 
                        experience in the science of managing 
                        captive chimpanzees (including primate 
                        veterinary care), appointed from among 
                        individuals endorsed by organizations 
                        that represent individuals in such 
                        field.
                            (iii) Such members include 
                        individuals with expertise and 
                        experience in the field of animal 
                        protection, appointed from among 
                        individuals endorsed by organizations 
                        that represent individuals in such 
                        field.
                            (iv) Such members include 
                        individuals with expertise and 
                        experience in the zoological field 
                        (including behavioral primatology), 
                        appointed from among individuals 
                        endorsed by organizations that 
                        represent individuals in such field.
                            (v) Such members include 
                        individuals with expertise and 
                        experience in the field of the business 
                        and management of nonprofit 
                        organizations, appointed from among 
                        individuals endorsed by organizations 
                        that represent individuals in such 
                        field.
                            (vi) Such members include 
                        representatives from entities that 
                        provide accreditation in the field of 
                        laboratory animal medicine.
                            (vii) Such members include 
                        individuals with expertise and 
                        experience in the field of containing 
                        biohazards.
                            (viii) Such members include an 
                        additional member who serves as the 
                        chair of the board, appointed from 
                        among individuals who have been 
                        endorsed for purposes of clause (ii), 
                        (iii), (iv), or (v).
                            (ix) None of the members of the 
                        board has been fined for, or signed a 
                        consent decree for, any violation of 
                        the Animal Welfare Act.
                    (B) The terms of service for members of the 
                board of directors are in accordance with this 
                paragraph if the following conditions are met:
                            (i) The term of the chair of the 
                        board is 3 years.
                            (ii) The initial members of the 
                        board select, by a random method, one 
                        member from each of the six fields 
                        specified in subparagraph (A) to serve 
                        a term of 2 years and (in addition to 
                        the chair) one member from each of such 
                        fields to serve a term of 3 years.
                            (iii) After the initial terms under 
                        clause (ii) expire, each member of the 
                        board (other than the chair) is 
                        appointed to serve a term of 2 years.
                            (iv) An individual whose term of 
                        service expires may be reappointed to 
                        the board.
                            (v) A vacancy in the membership of 
                        the board is filled in the manner in 
                        which the original appointment was 
                        made.
                            (vi) If a member of the board does 
                        not serve the full term applicable to 
                        the member, the individual appointed to 
                        fill the resulting vacancy is appointed 
                        for the remainder of the term of the 
                        predecessor member.
            (4) Requirement of matching funds.--The agreement 
        required in paragraph (2)(E) for a nonprofit private 
        entity (relating to the award of the contract under 
        paragraph (1)) is an agreement that, with respect to 
        the costs to be incurred by the entity in establishing 
        and operating the sanctuary system, the entity will 
        make available (directly or through donations from 
        public or private entities) non-Federal contributions 
        toward such costs, in cash or in kind, in an amount not 
        less than the following, as applicable:
                    (A) For expenses associated with 
                establishing the sanctuary system (as 
                determined by the Secretary), 10 percent of 
                such costs ($1 for each $9 of Federal funds 
                provided under the contract under paragraph 
                (1)).
                    (B) For expenses associated with operating 
                the sanctuary system (as determined by the 
                Secretary), 25 percent of such costs ($1 for 
                each $3 of Federal funds provided under such 
                contract).
            (5) Establishment of contract entity.--If the 
        Secretary determines that an entity meeting the 
        requirements of paragraph (2) does not exist, not later 
        than 60 days after the date of the enactment of this 
        section, the Secretary shall, for purposes of paragraph 
        (1), make a grant for the establishment of such an 
        entity, including paying the cost of incorporating the 
        entity under the law of one of the States.
    (f ) Definitions.--For purposes of this section:
            (1) Permanent retirement.--The term ``permanent 
        retirement'', with respect to a chimpanzee that has 
        been accepted into the sanctuary system, means that 
        under subsection (a) the system provides for the 
        lifetime care of the chimpanzee, that under subsection 
        (d)(2) the system does not permit the chimpanzee to be 
        used in research (except as authorized under subsection 
        (d)(3)) or to be euthanized (except as provided in 
        subsection (d)(2)(I)), that under subsection (d)(2) the 
        system will not discharge the chimpanzee from the 
        system, and that under such subsection the system 
        otherwise cares for the chimpanzee.
            (2) Sanctuary system.--The term ``sanctuary 
        system'' means the system described in subsection (a).
            (3) Secretary.--The term ``Secretary'' means the 
        Secretary of Health and Human Services.
            (4) Surplus chimpanzees.--The term ``surplus 
        chimpanzees'' has the meaning given that term in 
        subsection (a).
    (g) Funding.--
            (1) In general.--Of the amount appropriated under 
        this Act for fiscal year 2001 and each subsequent 
        fiscal year, the Secretary, subject to paragraph (2), 
        shall reserve a portion for purposes of the operation 
        (and establishment, as applicable) of the sanctuary 
        system and for purposes of paragraph (3), except that 
        the Secretary may not for such purposes reserve any 
        further funds from such amount after the aggregate 
        total of the funds so reserved for such fiscal years 
        reaches $30,000,000. The purposes for which funds 
        reserved under the preceding sentence may be expended 
        include the construction and renovation of facilities 
        for the sanctuary system.
            (2) Limitation.--Funds may not be reserved for a 
        fiscal year under paragraph (1) unless the amount 
        appropriated under this Act for such year equals or 
        exceeds the amount appropriated under this Act for 
        fiscal year 1999.
            (3) Use of funds for other compliant facilities.--
        With respect to amounts reserved under paragraph (1) 
        for a fiscal year, the Secretary may use a portion of 
        such amounts to make awards of grants or contracts to 
        public or private entities operating facilities that, 
        as determined by the board of directors of the 
        nonprofit private entity that receives the contract 
        under subsection (e), provide for the retirement of 
        chimpanzees in accordance with the same standards that 
        apply to the sanctuary system pursuant to regulations 
        under subsection (d). Such an award may be expended for 
        the expenses of operating the facilities involved.

SEC. 481D. [287A-2] GENERAL CLINICAL RESEARCH CENTERS.

    (a) Grants.--The Director of the National Center for 
Research Resources shall award grants for the establishment of 
general clinical research centers to provide the infrastructure 
for clinical research including clinical research training and 
career enhancement. Such centers shall support clinical studies 
and career development in all settings of the hospital or 
academic medical center involved.
    (b) Activities.--In carrying out subsection (a), the 
Director of National Institutes of Health shall expand the 
activities of the general clinical research centers through the 
increased use of telecommunications and telemedicine 
initiatives.

 Subpart 2--John E. Fogarty International Center for Advanced Study in 
                          the Health Sciences

                            general purpose
    Sec. 482. [287b] The general purpose of the John E. Fogarty 
International Center for Advanced Study in the Health Sciences 
is to--
            (1) facilitate the assembly of scientists and 
        others in the biomedical, behavioral, and related 
        fields for discussion, study, and research relating to 
        the development of health science internationally;
            (2) provide research programs, conferences, and 
        seminars to further international cooperation and 
        collaboration in the life sciences;
            (3) provide postdoctorate fellowships for research 
        training in the United States and abroad and promote 
        exchanges of senior scientists between the United 
        States and other countries;
            (4) coordinate the activities of the National 
        Institutes of Health concerned with the health sciences 
        internationally; and
            (5) receive foreign visitors to the National 
        Institutes of Health.

              Subpart 4--Office of Dietary Supplements \1\
---------------------------------------------------------------------------

    \1\ Subpart 3 of this part was transferred and redesignated as 
subpart 19 of part C by section 101(c) of Public Law 109-482.
---------------------------------------------------------------------------

SEC. 485C. [287C-11] DIETARY SUPPLEMENTS.

    (a) Establishment.--The Secretary shall establish an Office 
of Dietary Supplements within the National Institutes of 
Health.
    (b) Purpose.--The purposes of the Office are--
            (1) to explore more fully the potential role of 
        dietary supplements as a significant part of the 
        efforts of the United States to improve health care; 
        and
            (2) to promote scientific study of the benefits of 
        dietary supplements in maintaining health and 
        preventing chronic disease and other health-related 
        conditions.
    (c) Duties.--The Director of the Office of Dietary 
Supplements shall--
            (1) conduct and coordinate scientific research 
        within the National Institutes of Health relating to 
        dietary supplements and the extent to which the use of 
        dietary supplements can limit or reduce the risk of 
        diseases such as heart disease, cancer, birth defects, 
        osteoporosis, cataracts, or prostatism;
            (2) collect and compile the results of scientific 
        research relating to dietary supplements, including 
        scientific data from foreign sources or the Office of 
        Alternative Medicine;
            (3) serve as the principal advisor to the Secretary 
        and to the Assistant Secretary for Health and provide 
        advice to the Director of the National Institutes of 
        Health, the Director of the Centers for Disease Control 
        and Prevention, and the Commissioner of Food and Drugs 
        on issues relating to dietary supplements including--
                    (A) dietary intake regulations;
                    (B) the safety of dietary supplements;
                    (C) claims characterizing the relationship 
                between--
                            (i) dietary supplements; and
                            (ii)(I) prevention of disease or 
                        other health-related conditions; and
                            (II) maintenance of health; and
                    (D) scientific issues arising in connection 
                with the labeling and composition of dietary 
                supplements;
            (4) compile a database of scientific research on 
        dietary supplements and individual nutrients; and
            (5) coordinate funding relating to dietary 
        supplements for the National Institutes of Health.
    (d) Definition.--As used in this section, the term 
``dietary supplement'' has the meaning given the term in 
section 201(ff) of the Federal Food, Drug, and Cosmetic Act.

 Subpart 5--National Center for Complementary and Alternative Medicine

SEC. 485D. [287C-21] PURPOSE OF CENTER.

    (a) In General.--The general purposes of the National 
Center for Complementary and Alternative Medicine (in this 
subpart referred to as the ``Center'') are the conduct and 
support of basic and applied research (including both 
intramural and extramural research), research training, the 
dissemination of health information, and other programs with 
respect to identifying, investigating, and validating 
complementary and alternative treatment, diagnostic and 
prevention modalities, disciplines and systems. The Center 
shall be headed by a director, who shall be appointed by the 
Secretary. The Director of the Center shall report directly to 
the Director of NIH.
    (b) Advisory Council.--The Secretary shall establish an 
advisory council for the Center in accordance with section 406, 
except that at least half of the members of the advisory 
council who are not ex officio members shall include 
practitioners licensed in one or more of the major systems with 
which the Center is concerned, and at least 3 individuals 
representing the interests of individual consumers of 
complementary and alternative medicine.
    (c) Complement to Conventional Medicine.--In carrying out 
subsection (a), the Director of the Center shall, as 
appropriate, study the integration of alternative treatment, 
diagnostic and prevention systems, modalities, and disciplines 
with the practice of conventional medicine as a complement to 
such medicine and into health care delivery systems in the 
United States.
    (d) Appropriate Scientific Expertise and Coordination With 
Institutes and Federal Agencies.--The Director of the Center, 
after consultation with the advisory council for the Center and 
the division of research grants, shall ensure that scientists 
with appropriate expertise in research on complementary and 
alternative medicine are incorporated into the review, 
oversight, and management processes of all research projects 
and other activities funded by the Center. In carrying out this 
subsection, the Director of the Center, as necessary, may 
establish review groups with appropriate scientific expertise. 
The Director of the Center shall coordinate efforts with other 
Institutes and Federal agencies to ensure appropriate 
scientific input and management.
    (e) Evaluation of Various Disciplines and Systems.--In 
carrying out subsection (a), the Director of the Center shall 
identify and evaluate alternative and complementary medical 
treatment, diagnostic and prevention modalities in each of the 
disciplines and systems with which the Center is concerned, 
including each discipline and system in which accreditation, 
national certification, or a State license is available.
    (f) Ensuring High Quality, Rigorous Scientific Review.--In 
order to ensure high quality, rigorous scientific review of 
complementary and alternative, diagnostic and prevention 
modalities, disciplines and systems, the Director of the Center 
shall conduct or support the following activities:
            (1) Outcomes research and investigations.
            (2) Epidemiological studies.
            (3) Health services research.
            (4) Basic science research.
            (5) Clinical trials.
            (6) Other appropriate research and investigational 
        activities.
The Director of NIH, in coordination with the Director of the 
Center, shall designate specific personnel in each Institute to 
serve as full-time liaisons with the Center in facilitating 
appropriate coordination and scientific input.
    (g) Data System; Information Clearinghouse.--
            (1) Data system.--The Director of the Center shall 
        establish a bibliographic system for the collection, 
        storage, and retrieval of worldwide research relating 
        to complementary and alternative treatment, diagnostic 
        and prevention modalities, disciplines and systems. 
        Such a system shall be regularly updated and publicly 
        accessible.
            (2) Clearinghouse.--The Director of the Center 
        shall establish an information clearinghouse to 
        facilitate and enhance, through the effective 
        dissemination of information, knowledge and 
        understanding of alternative medical treatment, 
        diagnostic and prevention practices by health 
        professionals, patients, industry, and the public.
    (h) Research Centers.--The Director of the Center, after 
consultation with the advisory council for the Center, shall 
provide support for the development and operation of 
multipurpose centers to conduct research and other activities 
described in subsection (a) with respect to complementary and 
alternative treatment, diagnostic and prevention modalities, 
disciplines and systems. The provision of support for the 
development and operation of such centers shall include 
accredited complementary and alternative medicine research and 
education facilities.
    (i) Availability of Resources.--After consultation with the 
Director of the Center, the Director of NIH shall ensure that 
resources of the National Institutes of Health, including 
laboratory and clinical facilities, fellowships (including 
research training fellowship and junior and senior clinical 
fellowships), and other resources are sufficiently available to 
enable the Center to appropriately and effectively carry out 
its duties as described in subsection (a). The Director of NIH, 
in coordination with the Director of the Center, shall 
designate specific personnel in each Institute to serve as 
full-time liaisons with the Center in facilitating appropriate 
coordination and scientific input.
    (j) Availability of Appropriations.--Amounts appropriated 
to carry out this section for fiscal year 1999 are available 
for obligation through September 30, 2001. Amounts appropriated 
to carry out this section for fiscal year 2000 are available 
for obligation through September 30, 2001.

                   Part F--Research on Women's Health

SEC. 486. [287D] OFFICE OF RESEARCH ON WOMEN'S HEALTH.

    (a) Establishment.--There is established within the Office 
of the Director of NIH an office to be known as the Office of 
Research on Women's Health (in this part referred to as the 
``Office''). The Office shall be headed by a director, who 
shall be appointed by the Director of NIH and who shall report 
directly to the Director.
    (b) Purpose.--The Director of the Office shall--
            (1) identify projects of research on women's health 
        that should be conducted or supported by the national 
        research institutes;
            (2) identify multidisciplinary research relating to 
        research on women's health that should be so conducted 
        or supported;
            (3) carry out paragraphs (1) and (2) with respect 
        to the aging process in women, with priority given to 
        menopause;
            (4) promote coordination and collaboration among 
        entities conducting research identified under any of 
        paragraphs (1) through (3);
            (5) encourage the conduct of such research by 
        entities receiving funds from the national research 
        institutes;
            (6) recommend an agenda for conducting and 
        supporting such research;
            (7) promote the sufficient allocation of the 
        resources of the national research institutes for 
        conducting and supporting such research;
            (8) assist in the administration of section 492B 
        with respect to the inclusion of women as subjects in 
        clinical research; and
            (9) prepare the report required in section 486B.
    (c) Coordinating Committee.--
            (1) In carrying out subsection (b), the Director of 
        the Office shall establish a committee to be known as 
        the Coordinating Committee on Research on Women's 
        Health (in this subsection referred to as the 
        ``Coordinating Committee'').
            (2) The Coordinating Committee shall be composed of 
        the Directors of the national research institutes (or 
        the designees of the Directors).
            (3) The Director of the Office shall serve as the 
        chair of the Coordinating Committee.
            (4) With respect to research on women's health, the 
        Coordinating Committee shall assist the Director of the 
        Office in--
                    (A) identifying the need for such research, 
                and making an estimate each fiscal year of the 
                funds needed to adequately support the 
                research;
                    (B) identifying needs regarding the 
                coordination of research activities, including 
                intramural and extramural multidisciplinary 
                activities;
                    (C) supporting the development of 
                methodologies to determine the circumstances in 
                which obtaining data specific to women 
                (including data relating to the age of women 
                and the membership of women in ethnic or racial 
                groups) is an appropriate function of clinical 
                trials of treatments and therapies;
                    (D) supporting the development and 
                expansion of clinical trials of treatments and 
                therapies for which obtaining such data has 
                been determined to be an appropriate function; 
                and
                    (E) encouraging the national research 
                institutes to conduct and support such 
                research, including such clinical trials.
    (d) Advisory Committee.--
            (1) In carrying out subsection (b), the Director of 
        the Office shall establish an advisory committee to be 
        known as the Advisory Committee on Research on Women's 
        Health (in this subsection referred to as the 
        ``Advisory Committee'').
            (2) The Advisory Committee shall be composed of no 
        fewer than 12, and not more than 18 individuals, who 
        are not officers or employees of the Federal 
        Government. The Director of NIH shall make appointments 
        to the Advisory Committee from among physicians, 
        practitioners, scientists, and other health 
        professionals, whose clinical practice, research 
        specialization, or professional expertise includes a 
        significant focus on research on women's health. A 
        majority of the members of the Advisory Committee shall 
        be women.
            (3) The Director of the Office shall serve as the 
        chair of the Advisory Committee.
            (4) The Advisory Committee shall--
                    (A) advise the Director of the Office on 
                appropriate research activities to be 
                undertaken by the national research institutes 
                with respect to--
                            (i) research on women's health;
                            (ii) research on gender differences 
                        in clinical drug trials, including 
                        responses to pharmacological drugs;
                            (iii) research on gender 
                        differences in disease etiology, 
                        course, and treatment;
                            (iv) research on obstetrical and 
                        gynecological health conditions, 
                        diseases, and treatments; and
                            (v) research on women's health 
                        conditions which require a 
                        multidisciplinary approach;
                    (B) report to the Director of the Office on 
                such research;
                    (C) provide recommendations to such 
                Director regarding activities of the Office 
                (including recommendations on the development 
                of the methodologies described in subsection 
                (c)(4)(C) and recommendations on priorities in 
                carrying out research described in subparagraph 
                (A)); and
                    (D) assist in monitoring compliance with 
                section 492B regarding the inclusion of women 
                in clinical research.
            (5)(A) The Advisory Committee shall prepare a 
        biennial report describing the activities of the 
        Committee, including findings made by the Committee 
        regarding--
                    (i) compliance with section 492B;
                    (ii) the extent of expenditures made for 
                research on women's health by the agencies of 
                the National Institutes of Health; and
                    (iii) the level of funding needed for such 
                research.
            (B) The report required in subparagraph (A) shall 
        be submitted to the Director of NIH for inclusion in 
        the report required in section 403.
    (e) Representation of Women Among Researchers.--The 
Secretary, acting through the Assistant Secretary for Personnel 
and in collaboration with the Director of the Office, shall 
determine the extent to which women are represented among 
senior physicians and scientists of the national research 
institutes and among physicians and scientists conducting 
research with funds provided by such institutes, and as 
appropriate, carry out activities to increase the extent of 
such representation.
    (f) Definitions.--For purposes of this part:
            (1) The term ``women's health conditions'', with 
        respect to women of all age, ethnic, and racial groups, 
        means all diseases, disorders, and conditions 
        (including with respect to mental health)--
                    (A) unique to, more serious, or more 
                prevalent in women;
                    (B) for which the factors of medical risk 
                or types of medical intervention are different 
                for women, or for which it is unknown whether 
                such factors or types are different for women; 
                or
                    (C) with respect to which there has been 
                insufficient clinical research involving women 
                as subjects or insufficient clinical data on 
                women.
            (2) The term ``research on women's health'' means 
        research on women's health conditions, including 
        research on preventing such conditions.

SEC. 486A. [287D-1] NATIONAL DATA SYSTEM AND CLEARINGHOUSE ON RESEARCH 
                    ON WOMEN'S HEALTH.

    (a) Data System.--
            (1) The Director of NIH, in consultation with the 
        Director of the Office and the Director of the National 
        Library of Medicine, shall establish a data system for 
        the collection, storage, analysis, retrieval, and 
        dissemination of information regarding research on 
        women's health that is conducted or supported by the 
        national research institutes. Information from the data 
        system shall be available through information systems 
        available to health care professionals and providers, 
        researchers, and members of the public.
            (2) The data system established under paragraph (1) 
        shall include a registry of clinical trials of 
        experimental treatments that have been developed for 
        research on women's health. Such registry shall include 
        information on subject eligibility criteria, sex, age, 
        ethnicity or race, and the location of the trial site 
        or sites. Principal investigators of such clinical 
        trials shall provide this information to the registry 
        within 30 days after it is available. Once a trial has 
        been completed, the principal investigator shall 
        provide the registry with information pertaining to the 
        results, including potential toxicities or adverse 
        effects associated with the experimental treatment or 
        treatments evaluated.
    (b) Clearinghouse.--The Director of NIH, in consultation 
with the Director of the Office and with the National Library 
of Medicine, shall establish, maintain, and operate a program 
to provide information on research and prevention activities of 
the national research institutes that relate to research on 
women's health.

SEC. 486B. [287D-2] BIENNIAL REPORT.

    (a) In General.--With respect to research on women's 
health, the Director of the Office shall, not later than 
February 1, 1994, and biennially thereafter, prepare a report--
            (1) describing and evaluating the progress made 
        during the preceding 2 fiscal years in research and 
        treatment conducted or supported by the National 
        Institutes of Health;
            (2) describing and analyzing the professional 
        status of women physicians and scientists of such 
        Institutes, including the identification of problems 
        and barriers regarding advancements;
            (3) summarizing and analyzing expenditures made by 
        the agencies of such Institutes (and by such Office) 
        during the preceding 2 fiscal years; and
            (4) making such recommendations for legislative and 
        administrative initiatives as the Director of the 
        Office determines to be appropriate.
    (b) Inclusion in Biennial Report of Director of NIH.--The 
Director of the Office shall submit each report prepared under 
subsection (a) to the Director of NIH for inclusion in the 
report submitted to the President and the Congress under 
section 403.

                      Part G--Awards and Training

        Ruth L. Kirschstein National Research Service Awards \1\

    Sec. 487. [288] (a)(1) The Secretary shall--
---------------------------------------------------------------------------
    \1\ The typeface is so in law. See section 804(b) of Public Law 
107-206 (116 Stat. 874).
---------------------------------------------------------------------------
            (A) provide Ruth L. Kirschstein National Research 
        Service Awards \2\ for--
---------------------------------------------------------------------------
    \2\ Section 804(c) of Public Law 107-206 (116 Stat. 874) provides 
as follows:
    ``(c) Any reference in any law (other than this Act), regulation, 
document, record, map, or other paper of the United States to `National 
Research Service Awards' shall be considered to be a reference to `Ruth 
L. Kirschstein National Research Service Awards'''.
---------------------------------------------------------------------------
                    (i) biomedical and behavioral research at 
                the National Institutes of Health in matters 
                relating to the cause, diagnosis, prevention, 
                and treatment of the diseases or other health 
                problems to which the activities of the 
                National Institutes of Health and 
                Administration \1\ are directed;
                    (ii) training at the National Institutes of 
                Health and at the Administration \1\ of 
                individuals to undertake such research;
                    (iii) biomedical and behavioral research 
                and health services research (including 
                research in primary medical care) at public and 
                nonprofit private entities; and
                    (iv) pre-doctoral and post-doctoral 
                training at public and private institutions of 
                individuals to undertake biomedical and 
                behavioral research;
            (B) make grants to public and nonprofit private 
        institutions to enable such institutions to make Ruth 
        L. Kirschstein National Research Service Awards for 
        research (and training to undertake biomedical and 
        behavioral research) in the matters described in 
        subparagraph (A)(i) to individuals selected by such 
        institutions; and
            (C) provide contracts for scholarships and loan 
        repayments in accordance with sections 487D and 487E, 
        subject to providing not more than an aggregate 50 such 
        contracts during the fiscal years 1994 through 1996.
A reference in this subsection to the National Institutes of 
Health shall be considered to include the institutes, agencies, 
divisions, and bureaus included in the National Institutes of 
Health or under the Administration, \1\ as the case may be.
---------------------------------------------------------------------------
    \1\ So in law. Section 163(b)(4)(B) of Public Law 102-321 (106 
Stat. 376) struck a reference in paragraph (1) to the former Alcohol, 
Drug Abuse, and Mental Health Administration, but failed to conform 
related references.
---------------------------------------------------------------------------
    (2) Ruth L. Kirschstein National Research Service Awards 
may not be used to support residency training of physicians and 
other health professionals.
    (3) In awarding Ruth L. Kirschstein National Research 
Service Awards under this section, the Secretary shall take 
account of the Nation's overall need for biomedical research 
personnel by giving special consideration to physicians who 
agree to undertake a minimum of two years of biomedical 
research.
    (4) The Secretary shall carry out paragraph (1) in a manner 
that will result in the recruitment of women, and individuals 
from disadvantaged backgrounds (including racial and ethnic 
minorities), into fields of biomedical or behavioral research 
and in the provision of research training to women and such 
individuals.
    (b)(1) No Ruth L. Kirschstein National Research Service 
Award may be made by the Secretary to any individual unless--
            (A) the individual has submitted to the Secretary 
        an application therefor and the Secretary has approved 
        the application;
            (B) the individual provides, in such form and 
        manner as the Secretary shall by regulation prescribe, 
        assurances satisfactory to the Secretary that the 
        individual will meet the service requirement of 
        subsection (c); and
            (C) in the case of a Ruth L. Kirschstein National 
        Research Service Award for a purpose described in 
        subsection (a)(1)(A)(iii), the individual has been 
        sponsored (in such manner as the Secretary may by 
        regulation require) by the institution at which the 
        research or training under the award will be conducted.
An application for an award shall be in such form, submitted in 
such manner, and contain such information, as the Secretary may 
by regulation prescribe.
    (2) The making of grants under subsection (a)(1)(B) for 
Ruth L. Kirschstein National Research Service Awards shall be 
subject to review and approval by the appropriate advisory 
councils within the Department of Health and Human Services (A) 
whose activities relate to the research or training under the 
awards, or (B) for the entity at which such research or 
training will be conducted.
    (3) No grant may be made under subsection (a)(1)(B) unless 
an application therefor has been submitted to and approved by 
the Secretary. Such application shall be in such form, 
submitted in such manner, and contain such information, as the 
Secretary may by regulation prescribe. Subject to the 
provisions of this section (other than paragraph (1)), Ruth L. 
Kirschstein National Research Service Awards made under a grant 
under subsection (a)(1)(B) shall be made in accordance with 
such regulations as the Secretary shall prescribe.
    (4) The period of any Ruth L. Kirschstein National Research 
Service Award made to any individual under subsection (a) may 
not exceed--
            (A) five years in the aggregate for pre-doctoral 
        training; and
            (B) three years in the aggregate for post-doctoral 
        training;
unless the Secretary for good cause shown waives the 
application of such limit to such individual.
    (5) Ruth L. Kirschstein National Research Service Awards 
shall provide for such stipends, tuition, fees, and allowances 
(including travel and subsistence expenses and dependency 
allowances), adjusted periodically to reflect increases in the 
cost of living, for the recipients of the awards as the 
Secretary may deem necessary. A Ruth L. Kirschstein National 
Research Service Award made to an individual for research or 
research training at a non-Federal public or nonprofit private 
institution shall also provide for payments to be made to the 
institution for the cost of support services (including the 
cost of faculty salaries, supplies, equipment, general research 
support, and related items) provided such individual by such 
institution. The amount of any such payments to any institution 
shall be determined by the Secretary and shall bear a direct 
relationship to the reasonable costs of the institution for 
establishing and maintaining the quality of its biomedical and 
behavioral research and training programs.
    (c)(1) Each individual who is awarded a Ruth L. Kirschstein 
National Research Service Award for postdoctoral research 
training shall, in accordance with paragraph (3), engage in 
research training, research, or teaching that is health-related 
(or any combination thereof) for the period specified in 
paragraph (2). Such period shall be served in accordance with 
the usual patterns of scientific employment.
    (2)(A) The period referred to in paragraph (1) is 12 
months, or one month for each month for which the individual 
involved receives a Ruth L. Kirschstein National Research 
Service Award for postdoctoral research training, whichever is 
less.
    (B) With respect to postdoctoral research training, in any 
case in which an individual receives a Ruth L. Kirschstein 
National Research Service Award for more than 12 months, the 
13th month and each subsequent month of performing activities 
under the Award shall be considered to be activities engaged in 
toward satisfaction of the requirement established in paragraph 
(1) regarding a period of service.
    (3) The requirement of paragraph (1) shall be complied with 
by any individual to whom it applies within such reasonable 
period of time, after the completion of such individual's 
award, as the Secretary shall by regulation prescribe. The 
Secretary shall by regulation prescribe the type of research 
and teaching in which an individual may engage to comply with 
such requirement and such other requirements respecting 
research and teaching as the Secretary considers appropriate.
    (4)(A) If any individual to whom the requirement of 
paragraph (1) is applicable fails, within the period prescribed 
by paragraph (3), to comply with such requirements, the United 
States shall be entitled to recover from such individual an 
amount determined in accordance with the formula--
      


                                                                 t--s
                                                A=f   <3-ln (> ------- <3-ln )>
                                                                  t
----------------------------------------------------------------------------------------------------------------


in which ``A'' is the amount the United States is entitled to 
recover; ``f'' is the sum of the total amount paid under one or 
more Ruth L. Kirschstein National Research Service Awards to 
such individual; ``t'' is the total number of months in such 
individual's service obligation; and ``s'' is the number of 
months of such obligation served by such individual in 
accordance with paragraphs (1) and (2) of this subsection.
    (B) Any amount which the United States is entitled to 
recover under subparagraph (A) shall, within the three-year 
period beginning on the date the United States becomes entitled 
to recover such amount, be paid to the United States. Until any 
amount due the United States under subparagraph (A) on account 
of any Ruth L. Kirschstein National Research Service Award is 
paid, there shall accrue to the United States interest on such 
amount at a rate fixed by the Secretary of the Treasury after 
taking into consideration private consumer rates of interest 
prevailing on the date the United States becomes entitled to 
such amount.
    (5)(A) Any obligation of an individual under paragraph (1) 
shall be canceled upon the death of such individual.
    (B) The Secretary shall by regulation provide for the 
waiver or suspension of any such obligation applicable to any 
individual whenever compliance by such individual is impossible 
or would involve substantial hardship to such individual or 
would be against equity and good conscience.
  loan repayment program for research with respect to acquired immune 
                          deficiency syndrome
    Sec. 487A. [288-1] (a) In General.--The Secretary shall 
carry out a program of entering into agreements with 
appropriately qualified health professionals under which such 
health professionals agree to conduct, as employees of the 
National Institutes of Health, research with respect to 
acquired immune deficiency syndrome in consideration of the 
Federal Government agreeing to repay, for each year of such 
service, not more than $35,000 of the principal and interest of 
the educational loans of such health professionals.
    (b) Applicability of Certain Provisions.--With respect to 
the National Health Service Corps Loan Repayment Program 
established in subpart III of part D of title III, the 
provisions of such subpart shall, except as inconsistent with 
subsection (a) of this section, apply to the program 
established in such subsection (a) in the same manner and to 
the same extent as such provisions apply to the National Health 
Service Corps Loan Repayment Program established in such 
subpart.
 loan repayment program for research with respect to contraception and 
                              infertility
    Sec. 487B. [288-2] (a) The Secretary, in consultation with 
the Director of the Eunice Kennedy Shriver National Institute 
of Child Health and Human Development, shall establish a 
program of entering into contracts with qualified health 
professionals (including graduate students) under which such 
health professionals agree to conduct research with respect to 
contraception, or with respect to infertility, in consideration 
of the Federal Government agreeing to repay, for each year of 
such service, not more than $35,000 of the principal and 
interest of the educational loans of such health professionals.
    (b) The provisions of sections 338B, 338C, and 338E shall, 
except as inconsistent with subsection (a) of this section, 
apply to the program established in subsection (a) to the same 
extent and in the same manner as such provisions apply to the 
National Health Service Corps Loan Repayment Program 
established in subpart III of part D of title III.
    (c) Amounts available for carrying out this section shall 
remain available until the expiration of the second fiscal year 
beginning after the fiscal year for which the amounts were made 
available.
             loan repayment program for research generally
    Sec. 487C. [288-3] (a) In General.--
            (1) Authority for program.--Subject to paragraph 
        (2), the Secretary shall carry out a program of 
        entering into contracts with appropriately qualified 
        health professionals under which such health 
        professionals agree to conduct research, as employees 
        of the National Institutes of Health, in consideration 
        of the Federal Government agreeing to repay, for each 
        year of such service, not more than $35,000 of the 
        principal and interest of the educational loans of such 
        health professionals.
            (2) Limitation.--The Secretary may not enter into 
        an agreement with a health professional pursuant to 
        paragraph (1) unless such professional--
                    (A) has a substantial amount of educational 
                loans relative to income; and
                    (B) agrees to serve as an employee of the 
                National Institutes of Health for purposes of 
                paragraph (1) for a period of not less than 3 
                years.
    (b) Applicability of Certain Provisions.--With respect to 
the National Health Service Corps Loan Repayment Program 
established in subpart III of part D of title III, the 
provisions of such subpart shall, except as inconsistent with 
subsection (a) of this section, apply to the program 
established in such subsection (a) in the same manner and to 
the same extent as such provisions apply to the National Health 
Service Corps Loan Repayment Program established in such 
subpart.
      h3  deg.undergraduate scholarship program regarding 
           professions needed by national research institutes
    Sec. 487D. [288-4] (a) Establishment of Program.--
            (1) In general.--Subject to section 487(a)(1)(C), 
        the Secretary, acting through the Director of NIH, may 
        carry out a program of entering into contracts with 
        individuals described in paragraph (2) under which--
                    (A) the Director of NIH agrees to provide 
                to the individuals scholarships for pursuing, 
                as undergraduates at accredited institutions of 
                higher education, academic programs appropriate 
                for careers in professions needed by the 
                National Institutes of Health; and
                    (B) the individuals agree to serve as 
                employees of the National Institutes of Health, 
                for the period described in subsection (c), in 
                positions that are needed by the National 
                Institutes of Health and for which the 
                individuals are qualified.
            (2) Individuals from disadvantaged backgrounds.--
        The individuals referred to in paragraph (1) are 
        individuals who--
                    (A) are enrolled or accepted for enrollment 
                as full-time undergraduates at accredited 
                institutions of higher education; and
                    (B) are from disadvantaged backgrounds.
    (b) Facilitation of Interest of Students in Careers at 
National Institutes of Health.--In providing employment to 
individuals pursuant to contracts under subsection (a)(1), the 
Director of NIH shall carry out activities to facilitate the 
interest of the individuals in pursuing careers as employees of 
the National Institutes of Health.
    (c) Period of Obligated Service.--
            (1) Duration of service.--For purposes of 
        subparagraph (B) of subsection (a)(1), the period of 
        service for which an individual is obligated to serve 
        as an employee of the National Institutes of Health is, 
        subject to paragraph (2)(A), 12 months for each 
        academic year for which the scholarship under such 
        subsection is provided.
            (2) Schedule for service.--
                    (A) Subject to subparagraph (B), the 
                Director of NIH may not provide a scholarship 
                under subsection (a) unless the individual 
                applying for the scholarship agrees that--
                            (i) the individual will serve as an 
                        employee of the National Institutes of 
                        Health full-time for not less than 10 
                        consecutive weeks of each year during 
                        which the individual is attending the 
                        educational institution involved and 
                        receiving such a scholarship;
                            (ii) the period of service as such 
                        an employee that the individual is 
                        obligated to provide under clause (i) 
                        is in addition to the period of service 
                        as such an employee that the individual 
                        is obligated to provide under 
                        subsection (a)(1)(B); and
                            (iii) not later than 60 days after 
                        obtaining the educational degree 
                        involved, the individual will begin 
                        serving full-time as such an employee 
                        in satisfaction of the period of 
                        service that the individual is 
                        obligated to provide under subsection 
                        (a)(1)(B).
                    (B) The Director of NIH may defer the 
                obligation of an individual to provide a period 
                of service under subsection (a)(1)(B), if the 
                Director determines that such a deferral is 
                appropriate.
            (3) Applicability of certain provisions relating to 
        appointment and compensation.--For any period in which 
        an individual provides service as an employee of the 
        National Institutes of Health in satisfaction of the 
        obligation of the individual under subsection (a)(1)(B) 
        or paragraph (2)(A)(i), the individual may be appointed 
        as such an employee without regard to the provisions of 
        title 5, United States Code, relating to appointment 
        and compensation.
    (d) Provisions Regarding Scholarship.--
            (1) Approval of academic program.--The Director of 
        NIH may not provide a scholarship under subsection (a) 
        for an academic year unless--
                    (A) the individual applying for the 
                scholarship has submitted to the Director a 
                proposed academic program for the year and the 
                Director has approved the program; and
                    (B) the individual agrees that the program 
                will not be altered without the approval of the 
                Director.
            (2) Academic standing.--The Director of NIH may not 
        provide a scholarship under subsection (a) for an 
        academic year unless the individual applying for the 
        scholarship agrees to maintain an acceptable level of 
        academic standing, as determined by the educational 
        institution involved in accordance with regulations 
        issued by the Secretary.
            (3) Limitation on amount.--The Director of NIH may 
        not provide a scholarship under subsection (a) for an 
        academic year in an amount exceeding $20,000.
            (4) Authorized uses.--A scholarship provided under 
        subsection (a) may be expended only for tuition 
        expenses, other reasonable educational expenses, and 
        reasonable living expenses incurred in attending the 
        school involved.
            (5) Contract regarding direct payments to 
        institution.--In the case of an institution of higher 
        education with respect to which a scholarship under 
        subsection (a) is provided, the Director of NIH may 
        enter into a contract with the institution under which 
        the amounts provided in the scholarship for tuition and 
        other educational expenses are paid directly to the 
        institution.
    (e) Penalties for Breach of Scholarship Contract.--The 
provisions of section 338E shall apply to the program 
established in subsection (a) to the same extent and in the 
same manner as such provisions apply to the National Health 
Service Corps Loan Repayment Program established in section 
338B.
    (f) Requirement of Application.--The Director of NIH may 
not provide a scholarship under subsection (a) unless an 
application for the scholarship is submitted to the Director 
and the application is in such form, is made in such manner, 
and contains such agreements, assurances, and information as 
the Director determines to be necessary to carry out this 
section.
    (g) Availability of Authorization of Appropriations.--
Amounts appropriated for a fiscal year for scholarships under 
this section shall remain available until the expiration of the 
second fiscal year beginning after the fiscal year for which 
the amounts were appropriated.
 h3  deg.loan repayment program regarding clinical researchers 
                     from disadvantaged backgrounds
    Sec. 487E. [288-5] (a) Implementation of Program.--
            (1) In general.--Subject to section 487(a)(1)(C), 
        the Secretary, acting through the Director of NIH may, 
        subject to paragraph (2), carry out a program of 
        entering into contracts with appropriately qualified 
        health professionals who are from disadvantaged 
        backgrounds under which such health professionals agree 
        to conduct clinical research in consideration of the 
        Federal Government agreeing to pay, for each year of 
        such service, not more than $35,000 of the principal 
        and interest of the educational loans of the health 
        professionals.
            (2) Limitation.--The Director of NIH may not enter 
        into a contract with a health professional pursuant to 
        paragraph (1) unless such professional has a 
        substantial amount of education loans relative to 
        income.
            (3) Applicability of certain provisions regarding 
        obligated service.--Except to the extent inconsistent 
        with this section, the provisions of sections 338B, 
        338C \1\ and 338E shall apply to the program 
        established in paragraph (1) to the same extent and in 
        the same manner as such provisions apply to the 
        National Health Service Corps Loan Repayment Program 
        established in section 338B.
---------------------------------------------------------------------------
    \1\ So in law. There is no comma after ``338C''.
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    (b) Availability of Authorization of Appropriations.--
Amounts appropriated for a fiscal year for contracts under 
subsection (a) shall remain available until the expiration of 
the second fiscal year beginning after the fiscal year for 
which the amounts were appropriated.

SEC. 487F. [288-5A] LOAN REPAYMENT PROGRAM REGARDING CLINICAL 
                    RESEARCHERS.

    (a) In General.--The Secretary, acting through the Director 
of the National Institutes of Health, shall establish a program 
to enter into contracts with qualified health professionals 
under which such health professionals agree to conduct clinical 
research, in consideration of the Federal Government agreeing 
to repay, for each year of service conducting such research, 
not more than $35,000 of the principal and interest of the 
educational loans of such health professionals.
    (b) Application of Provisions.--The provisions of sections 
338B, 338C, and 338E shall, except as inconsistent with 
subsection (a) of this section, apply to the program 
established under subsection (a) to the same extent and in the 
same manner as such provisions apply to the National Health 
Service Corps Loan Repayment Program established in subpart III 
of part D of title III.
               pediatric research loan repayment program
    Sec. 487F. \2\ [288-6] (a) In General.--The Secretary, in 
consultation with the Director of NIH, may establish a 
pediatric research loan repayment program. Through such 
program--
---------------------------------------------------------------------------
    \2\ So in law. There are two sections 487F. Section 1002(b) of 
Public Law 106-310 (114 Stat. 1129) inserted section 487F above. 
Subsequently, section 205 of Public Law 106-505 (114 Stat. 2329), which 
relates to a loan repayment program regarding clinical researchers, 
inserted a section 487F after section 487E.
---------------------------------------------------------------------------
            (1) the Secretary shall enter into contracts with 
        qualified health professionals under which such 
        professionals will agree to conduct pediatric research, 
        including pediatric pharmacological research, in 
        consideration of the Federal Government agreeing to 
        repay, for each year of such service, not more than 
        $35,000 of the principal and interest of the 
        educational loans of such professionals; and
            (2) the Secretary shall, for the purpose of 
        providing reimbursements for tax liability resulting 
        from payments made under paragraph (1) on behalf of an 
        individual, make payments, in addition to payments 
        under such paragraph, to the individual in an amount 
        equal to 39 percent of the total amount of loan 
        repayments made for the taxable year involved.
    (b) Application of Other Provisions.--The provisions of 
sections 338B, 338C, and 338E shall, except as inconsistent 
with paragraph (1), apply to the program established under such 
paragraph to the same extent and in the same manner as such 
provisions apply to the National Health Service Corps Loan 
Repayment Program established under subpart III of part D of 
title III.
    (c) Funding.--
            (1) In general.--For the purpose of carrying out 
        this section with respect to a national research 
        institute the Secretary may reserve, from amounts 
        appropriated for such institute for the fiscal year 
        involved, such amounts as the Secretary determines to 
        be appropriate.
            (2) Availability of funds.--Amounts made available 
        to carry out this section shall remain available until 
        the expiration of the second fiscal year beginning 
        after the fiscal year for which such amounts were made 
        available.
                       visiting scientist awards
    Sec. 488. [288a] (a) The Secretary may make awards 
(hereafter in this section referred to as ``Visiting Scientist 
Awards'') to outstanding scientists who agree to serve as 
visiting scientists at institutions of postsecondary education 
which have significant enrollments of disadvantaged students. 
Visiting Scientist Awards shall be made by the Secretary to 
enable the faculty and students of such institutions to draw 
upon the special talents of scientists from other institutions 
for the purpose of receiving guidance, advice, and instruction 
with regard to research, teaching, and curriculum development 
in the biomedical and behavioral sciences and such other 
aspects of these sciences as the Secretary shall deem 
appropriate.
    (b) The amount of each Visiting Scientist Award shall 
include such sum as shall be commensurate with the salary or 
remuneration which the individual receiving the award would 
have been entitled to receive from the institution with which 
the individual has, or had, a permanent or immediately prior 
affiliation. Eligibility for and terms of Visiting Scientist 
Awards shall be determined in accordance with regulations the 
Secretary shall prescribe.
    studies respecting biomedical and behavioral research personnel
    Sec. 489. [288b] (a) The Secretary shall, in accordance 
with subsection (b), arrange for the conduct of a continuing 
study to--
            (1) establish (A) the Nation's overall need for 
        biomedical and behavioral research personnel, (B) the 
        subject areas in which such personnel are needed and 
        the number of such personnel needed in each such area, 
        and (C) the kinds and extent of training which should 
        be provided such personnel;
            (2) assess (A) current training programs available 
        for the training of biomedical and behavioral research 
        personnel which are conducted under this Act, at or 
        through national research institutes under the National 
        Institutes of Health, and (B) other current training 
        programs available for the training of such personnel;
            (3) identify the kinds of research positions 
        available to and held by individuals completing such 
        programs;
            (4) determine, to the extent feasible, whether the 
        programs referred to in clause (B) of paragraph (2) 
        would be adequate to meet the needs established under 
        paragraph (1) if the programs referred to in clause (A) 
        of paragraph (2) were terminated; and
            (5) determine what modifications in the programs 
        referred to in paragraph (2) are required to meet the 
        needs established under paragraph (1).
    (b)(1) The Secretary shall request the National Academy of 
Sciences to conduct the study required by subsection (a) under 
an arrangement under which the actual expenses incurred by such 
Academy in conducting such study will be paid by the Secretary. 
If the National Academy of Sciences is willing to do so, the 
Secretary shall enter into such an arrangement with such 
Academy for the conduct of such study.
    (2) If the National Academy of Sciences is unwilling to 
conduct such study under such an arrangement, then the 
Secretary shall enter into a similar arrangement with other 
appropriate nonprofit private groups or associations under 
which such groups or associations will conduct such study and 
prepare and submit the reports thereon as provided in 
subsection (c).
    (3) The National Academy of Sciences or other group or 
association conducting the study required by subsection (a) 
shall conduct such study in consultation with the Director of 
NIH.
    (c) A report on the results of the study required under 
subsection (a) shall be submitted by the Secretary to the 
Committee on Energy and Commerce of the House of 
Representatives and the Committee on Labor and Human Resources 
of the Senate at least once every four years.

                       Part H--General Provisions

          institutional review boards; ethics guidance program
    Sec. 491. [289] (a) The Secretary shall by regulation 
require that each entity which applies for a grant, contract, 
or cooperative agreement under this Act for any project or 
program which involves the conduct of biomedical or behavioral 
research involving human subjects submit in or with its 
application for such grant, contract, or cooperative agreement 
assurances satisfactory to the Secretary that it has 
established (in accordance with regulations which the Secretary 
shall prescribe) a board (to be known as an ``Institutional 
Review Board'') to review biomedical and behavioral research 
involving human subjects conducted at or supported by such 
entity in order to protect the rights of the human subjects of 
such research.
    (b)(1) The Secretary shall establish a program within the 
Department of Health and Human Services under which requests 
for clarification and guidance with respect to ethical issues 
raised in connection with biomedical or behavioral research 
involving human subjects are responded to promptly and 
appropriately.
    (2) The Secretary shall establish a process for the prompt 
and appropriate response to information provided to the 
Director of NIH respecting incidences of violations of the 
rights of human subjects of research for which funds have been 
made available under this Act. The process shall include 
procedures for the receiving of reports of such information 
from recipients of funds under this Act and taking appropriate 
action with respect to such violations.
                        peer review requirements
    Sec. 492. [289a] (a)(1) The Secretary, acting through the 
Director of NIH, shall by regulation require appropriate 
technical and scientific peer review of--
            (A) applications made for grants and cooperative 
        agreements under this Act for biomedical and behavioral 
        research; and
            (B) applications made for biomedical and behavioral 
        research and development contracts to be administered 
        through the National Institutes of Health.
    (2) Regulations promulgated under paragraph (1) shall 
require that the review of applications made for grants, 
contracts, and cooperative agreements required by the 
regulations be conducted--
            (A) to the extent practical, in a manner consistent 
        with the system for technical and scientific peer 
        review applicable on the date of the date of enactment 
        of the Health Research Extension Act of 1985 to grants 
        under this Act for biomedical and behavioral research, 
        and
            (B) to the extent practical, by technical and 
        scientific peer review groups performing such review on 
        or before such date,
and shall authorize such review to be conducted by groups 
appointed under sections 402(b)(16) and 405(c)(3).
    (b) The Director of NIH shall establish procedures for 
periodic technical and scientific peer review of research at 
the National Institutes of Health. Such procedures shall 
require that--
            (1) the reviewing entity be provided a written 
        description of the research to be reviewed, and
            (2) the reviewing entity provide the advisory 
        council of the national research institute involved 
        with such description and the results of the review by 
        the entity,
and shall authorize such review to be conducted by groups 
appointed under sections 402(b)(6) and 405(c)(3).
    (c)(1) In technical and scientific peer review under this 
section of proposals for clinical research, the consideration 
of any such proposal (including the initial consideration) 
shall, except as provided in paragraph (2), include an 
evaluation of the technical and scientific merit of the 
proposal regarding compliance with section 492B.
    (2) Paragraph (1) shall not apply to any proposal for 
clinical research that, pursuant to subsection (b) of section 
492B, is not subject to the requirement of subsection (a) of 
such section regarding the inclusion of women and members of 
minority groups as subjects in clinical research.
   certain provisions regarding review and approval of proposals for 
                                research
    Sec. 492A. [289a-1] (a) Review as Precondition to 
Research.--
            (1) Protection of human research subjects.--
                    (A) In the case of any application 
                submitted to the Secretary for financial 
                assistance to conduct research, the Secretary 
                may not approve or fund any application that is 
                subject to review under section 491(a) by an 
                Institutional Review Board unless the 
                application has undergone review in accordance 
                with such section and has been recommended for 
                approval by a majority of the members of the 
                Board conducting such review.
                    (B) In the case of research that is subject 
                to review under procedures established by the 
                Secretary for the protection of human subjects 
                in clinical research conducted by the National 
                Institutes of Health, the Secretary may not 
                authorize the conduct of the research unless 
                the research has, pursuant to such procedures, 
                been recommended for approval.
            (2) Peer review.--In the case of any proposal for 
        the National Institutes of Health to conduct or support 
        research, the Secretary may not approve or fund any 
        proposal that is subject to technical and scientific 
        peer review under section 492 unless the proposal has 
        undergone such review in accordance with such section 
        and has been recommended for approval by a majority of 
        the members of the entity conducting such review, and 
        unless a majority of the voting members of the 
        appropriate advisory council under section 406, or as 
        applicable, of the advisory council under section 
        402(k), has recommended the proposal for approval.
    (b) Ethical Review of Research.--
            (1) Procedures regarding withholding of funds.--If 
        research has been recommended for approval for purposes 
        of subsection (a), the Secretary may not withhold funds 
        for the research because of ethical considerations 
        unless--
                    (A) the Secretary convenes an advisory 
                board in accordance with paragraph (5) to study 
                such considerations; and
                    (B)(i) the majority of the advisory board 
                recommends that, because of such 
                considerations, the Secretary withhold funds 
                for the research; or
                    (ii) the majority of such board recommends 
                that the Secretary not withhold funds for the 
                research because of such considerations, but 
                the Secretary finds, on the basis of the report 
                submitted under paragraph (5)(B)(ii), that the 
                recommendation is arbitrary and capricious.
            (2) Rules of construction.--Paragraph (1) may not 
        be construed as prohibiting the Secretary from 
        withholding funds for research on the basis of--
                    (A) the inadequacy of the qualifications of 
                the entities that would be involved with the 
                conduct of the research (including the entity 
                that would directly receive the funds from the 
                Secretary), subject to the condition that, with 
                respect to the process of review through which 
                the research was recommended for approval for 
                purposes of subsection (a), all findings 
                regarding such qualifications made in such 
                process are conclusive; or
                    (B) the priorities established by the 
                Secretary for the allocation of funds among 
                projects of research that have been so 
                recommended.
            (3) Applicability.--The limitation established in 
        paragraph (1) regarding the authority to withhold funds 
        because of ethical considerations shall apply without 
        regard to whether the withholding of funds on such 
        basis is characterized as a disapproval, a moratorium, 
        a prohibition, or other characterization.
            (4) Preliminary matters regarding use of 
        procedures.--
                    (A) If the Secretary makes a determination 
                that an advisory board should be convened for 
                purposes of paragraph (1), the Secretary shall, 
                through a statement published in the Federal 
                Register, announce the intention of the 
                Secretary to convene such a board.
                    (B) A statement issued under subparagraph 
                (A) shall include a request that interested 
                individuals submit to the Secretary 
                recommendations specifying the particular 
                individuals who should be appointed to the 
                advisory board involved. The Secretary shall 
                consider such recommendations in making 
                appointments to the board.
                    (C) The Secretary may not make appointments 
                to an advisory board under paragraph (1) until 
                the expiration of the 30-day period beginning 
                on the date on which the statement required in 
                subparagraph (A) is made with respect to the 
                board.
            (5) Ethics advisory boards.--
                    (A) Any advisory board convened for 
                purposes of paragraph (1) shall be known as an 
                ethics advisory board (in this paragraph 
                referred to as an ``ethics board'').
                    (B)(i) An ethics board shall advise, 
                consult with, and make recommendations to the 
                Secretary regarding the ethics of the project 
                of biomedical or behavioral research with 
                respect to which the board has been convened.
                    (ii) Not later than 180 days after the date 
                on which the statement required in paragraph 
                (4)(A) is made with respect to an ethics board, 
                the board shall submit to the Secretary, and to 
                the Committee on Energy and Commerce of the 
                House of Representatives and the Committee on 
                Labor and Human Resources of the Senate, a 
                report describing the findings of the board 
                regarding the project of research involved and 
                making a recommendation under clause (i) of 
                whether the Secretary should or should not 
                withhold funds for the project. The report 
                shall include the information considered in 
                making the findings.
                    (C) An ethics board shall be composed of no 
                fewer than 14, and no more than 20, individuals 
                who are not officers or employees of the United 
                States. The Secretary shall make appointments 
                to the board from among individuals with 
                special qualifications and competence to 
                provide advice and recommendations regarding 
                ethical matters in biomedical and behavioral 
                research. Of the members of the board--
                            (i) no fewer than 1 shall be an 
                        attorney;
                            (ii) no fewer than 1 shall be an 
                        ethicist;
                            (iii) no fewer than 1 shall be a 
                        practicing physician;
                            (iv) no fewer than 1 shall be a 
                        theologian; and
                            (v) no fewer than one-third, and no 
                        more than one-half, shall be scientists 
                        with substantial accomplishments in 
                        biomedical or behavioral research.
                    (D) The term of service as a member of an 
                ethics board shall be for the life of the 
                board. If such a member does not serve the full 
                term of such service, the individual appointed 
                to fill the resulting vacancy shall be 
                appointed for the remainder of the term of the 
                predecessor of the individual.
                    (E) A member of an ethics board shall be 
                subject to removal from the board by the 
                Secretary for neglect of duty or malfeasance or 
                for other good cause shown.
                    (F) The Secretary shall designate an 
                individual from among the members of an ethics 
                board to serve as the chair of the board.
                    (G) In carrying out subparagraph (B)(i) 
                with respect to a project of research, an 
                ethics board shall conduct inquiries and hold 
                public hearings.
                    (H) In carrying out subparagraph (B)(i) 
                with respect to a project of research, an 
                ethics board shall have access to all relevant 
                information possessed by the Department of 
                Health and Human Services, or available to the 
                Secretary from other agencies.
                    (I) Members of an ethics board shall 
                receive compensation for each day engaged in 
                carrying out the duties of the board, including 
                time engaged in traveling for purposes of such 
                duties. Such compensation may not be provided 
                in an amount in excess of the maximum rate of 
                basic pay payable for GS-18 of the General 
                Schedule.
                    (J) The Secretary, acting through the 
                Director of the National Institutes of Health, 
                shall provide to each ethics board reasonable 
                staff and assistance to carry out the duties of 
                the board.
                    (K) An ethics board shall terminate 30 days 
                after the date on which the report required in 
                subparagraph (B)(ii) is submitted to the 
                Secretary and the congressional committees 
                specified in such subparagraph.
            (6) Definition.--For purposes of this subsection, 
        the term ``ethical considerations'' means 
        considerations as to whether the nature of the research 
        involved is such that it is unethical to conduct or 
        support the research.
         inclusion of women and minorities in clinical research
    Sec. 492B. [289a-2] (a) Requirement of Inclusion.--
            (1) In general.--In conducting or supporting 
        clinical research for purposes of this title, the 
        Director of NIH shall, subject to subsection (b), 
        ensure that--
                    (A) women are included as subjects in each 
                project of such research; and
                    (B) members of minority groups are included 
                as subjects in such research.
            (2) Outreach regarding participation as subjects.--
        The Director of NIH, in consultation with the Director 
        of the Office of Research on Women's Health and the 
        Director of the Office of Research on Minority Health, 
        shall conduct or support outreach programs for the 
        recruitment of women and members of minority groups as 
        subjects in projects of clinical research.
    (b) Inapplicability of Requirement.--The requirement 
established in subsection (a) regarding women and members of 
minority groups shall not apply to a project of clinical 
research if the inclusion, as subjects in the project, of women 
and members of minority groups, respectively--
            (1) is inappropriate with respect to the health of 
        the subjects;
            (2) is inappropriate with respect to the purpose of 
        the research; or
            (3) is inappropriate under such other circumstances 
        as the Director of NIH may designate.
    (c) Design of Clinical Trials.--In the case of any clinical 
trial in which women or members of minority groups will under 
subsection (a) be included as subjects, the Director of NIH 
shall ensure that the trial is designed and carried out in a 
manner sufficient to provide for a valid analysis of whether 
the variables being studied in the trial affect women or 
members of minority groups, as the case may be, differently 
than other subjects in the trial.
    (d) Guidelines.--
            (1) In general.--Subject to paragraph (2), the 
        Director of NIH, in consultation with the Director of 
        the Office of Research on Women's Health and the 
        Director of the Office of Research on Minority Health, 
        shall establish guidelines regarding the requirements 
        of this section. The guidelines shall include 
        guidelines regarding--
                    (A) the circumstances under which the 
                inclusion of women and minorities as subjects 
                in projects of clinical research is 
                inappropriate for purposes of subsection (b);
                    (B) the manner in which clinical trials are 
                required to be designed and carried out for 
                purposes of subsection (c); and
                    (C) the operation of outreach programs 
                under subsection (a).
            (2) Certain provisions.--With respect to the 
        circumstances under which the inclusion of women or 
        members of minority groups (as the case may be) as 
        subjects in a project of clinical research is 
        inappropriate for purposes of subsection (b), the 
        following applies to guidelines under paragraph (1):
                    (A)(i) In the case of a clinical trial, the 
                guidelines shall provide that the costs of such 
                inclusion in the trial is not a permissible 
                consideration in determining whether such 
                inclusion is inappropriate.
                    (ii) In the case of other projects of 
                clinical research, the guidelines shall provide 
                that the costs of such inclusion in the project 
                is not a permissible consideration in 
                determining whether such inclusion is 
                inappropriate unless the data regarding women 
                or members of minority groups, respectively, 
                that would be obtained in such project (in the 
                event that such inclusion were required) have 
                been or are being obtained through other means 
                that provide data of comparable quality.
                    (B) In the case of a clinical trial, the 
                guidelines may provide that such inclusion in 
                the trial is not required if there is 
                substantial scientific data demonstrating that 
                there is no significant difference between--
                            (i) the effects that the variables 
                        to be studied in the trial have on 
                        women or members of minority groups, 
                        respectively; and
                            (ii) the effects that the variables 
                        have on the individuals who would serve 
                        as subjects in the trial in the event 
                        that such inclusion were not required.
    (e) Date Certain for Guidelines; Applicability.--
            (1) Date certain.--The guidelines required in 
        subsection (d) shall be established and published in 
        the Federal Register not later than 180 days after the 
        date of the enactment of the National Institutes of 
        Health Revitalization Act of 1993.
            (2) Applicability.--For fiscal year 1995 and 
        subsequent fiscal years, the Director of NIH may not 
        approve any proposal of clinical research to be 
        conducted or supported by any agency of the National 
        Institutes of Health unless the proposal specifies the 
        manner in which the research will comply with this 
        section.
    (f) Reports by Advisory Councils.--The advisory council of 
each national research institute shall prepare biennial reports 
describing the manner in which the institute has complied with 
this section. Each such report shall be submitted to the 
Director of the institute involved for inclusion in the 
biennial report under section 403.
    (g) Definitions.--For purposes of this section:
            (1) The term ``project of clinical research'' 
        includes a clinical trial.
            (2) The term ``minority group'' includes 
        subpopulations of minority groups. The Director of NIH 
        shall, through the guidelines established under 
        subsection (d), define the terms ``minority group'' and 
        ``subpopulation'' for purposes of the preceding 
        sentence.
                      office of research integrity
    Sec. 493. [289b] (a) In General.--
            (1) Establishment of office.--Not later than 90 
        days after the date of enactment of this section, the 
        Secretary shall establish an office to be known as the 
        Office of Research Integrity (referred to in this 
        section as the ``Office''), which shall be established 
        as an independent entity in the Department of Health 
        and Human Services.
            (2) Appointment of director.--The Office shall be 
        headed by a Director, who shall be appointed by the 
        Secretary, be experienced and specially trained in the 
        conduct of research, and have experience in the conduct 
        of investigations of research misconduct. The Secretary 
        shall carry out this section acting through the 
        Director of the Office. The Director shall report to 
        the Secretary.
            (3) Definitions.--
                    (A) The Secretary shall by regulation 
                establish a definition for the term ``research 
                misconduct'' for purposes of this section.
                    (B) For purposes of this section, the term 
                ``financial assistance'' means a grant, 
                contract, or cooperative agreement.
    (b) Existence of Administrative Processes as Condition of 
Funding for Research.--The Secretary shall by regulation 
require that each entity that applies for financial assistance 
under this Act for any project or program that involves the 
conduct of biomedical or behavioral research submit in or with 
its application for such assistance--
            (1) assurances satisfactory to the Secretary that 
        such entity has established and has in effect (in 
        accordance with regulations which the Secretary shall 
        prescribe) an administrative process to review reports 
        of research misconduct in connection with biomedical 
        and behavioral research conducted at or sponsored by 
        such entity;
            (2) an agreement that the entity will report to the 
        Director any investigation of alleged research 
        misconduct in connection with projects for which funds 
        have been made available under this Act that appears 
        substantial; and
            (3) an agreement that the entity will comply with 
        regulations issued under this section.
    (c) Process for Response of Director.--The Secretary shall 
by regulation establish a process to be followed by the 
Director for the prompt and appropriate--
            (1) response to information provided to the 
        Director respecting research misconduct in connection 
        with projects for which funds have been made available 
        under this Act;
            (2) receipt of reports by the Director of such 
        information from recipients of funds under this Act;
            (3) conduct of investigations, when appropriate; 
        and
            (4) taking of other actions, including appropriate 
        remedies, with respect to such misconduct.
    (d) Monitoring by Director.--The Secretary shall by 
regulation establish procedures for the Director to monitor 
administrative processes and investigations that have been 
established or carried out under this section.
    (e) Protection of Whistleblowers.--
            (1) In general.--In the case of any entity required 
        to establish administrative processes under subsection 
        (b), the Secretary shall by regulation establish 
        standards for preventing, and for responding to the 
        occurrence of retaliation by such entity, its officials 
        or agents, against an employee in the terms and 
        conditions of employment in response to the employee 
        having in good faith--
                    (A) made an allegation that the entity, its 
                officials or agents, has engaged in or failed 
                to adequately respond to an allegation of 
                research misconduct; or
                    (B) cooperated with an investigation of 
                such an allegation.
            (2) Monitoring by secretary.--The Secretary shall 
        by regulation establish procedures for the Director to 
        monitor the implementation of the standards established 
        by an entity under paragraph (1) for the purpose of 
        determining whether the procedures have been 
        established, and are being utilized, in accordance with 
        the standards established under such paragraph.
            (3) Noncompliance.--The Secretary shall by 
        regulation establish remedies for noncompliance by an 
        entity, its officials or agents, which has engaged in 
        retaliation in violation of the standards established 
        under paragraph (1). Such remedies may include 
        termination of funding provided by the Secretary for 
        such project or recovery of funding being provided by 
        the Secretary for such project, or other actions as 
        appropriate.
protection against financial conflicts of interest in certain projects 
                              of research
    Sec. 493A. [289b-1] (a) Issuance of Regulations.--The 
Secretary shall by regulation define the specific circumstances 
that constitute the existence of a financial interest in a 
project on the part of an entity or individual that will, or 
may be reasonably expected to, create a bias in favor of 
obtaining results in such project that are consistent with such 
financial interest. Such definition shall apply uniformly to 
each entity or individual conducting a research project under 
this Act. In the case of any entity or individual receiving 
assistance from the Secretary for a project of research 
described in subsection (b), the Secretary shall by regulation 
establish standards for responding to, including managing, 
reducing, or eliminating, the existence of such a financial 
interest. The entity may adopt individualized procedures for 
implementing the standards.
    (b) Relevant Projects.--A project of research referred to 
in subsection (a) is a project of clinical research whose 
purpose is to evaluate the safety or effectiveness of a drug, 
medical device, or treatment and for which such entity is 
receiving assistance from the Secretary.
    (c) Identifying and Reporting to Secretary.--The Secretary 
shall by regulation require that each entity described in 
subsection (a) that applies for assistance under this Act for 
any project described in subsection (b) submit in or with its 
application for such assistance--
            (1) assurances satisfactory to the Secretary that 
        such entity has established and has in effect an 
        administrative process under subsection (a) to identify 
        financial interests (as defined under subsection (a)) 
        that exist regarding the project; and
            (2) an agreement that the entity will report to the 
        Secretary such interests identified by the entity and 
        how any such interests identified by the entity will be 
        managed or eliminated in order that the project in 
        question will be protected from bias that may stem from 
        such interests; and
            (3) an agreement that the entity will comply with 
        regulations issued under this section.
    (d) Monitoring of Process.--The Secretary shall monitor the 
establishment and conduct of the administrative process 
established by an entity pursuant to subsection (a).
    (e) Response.--In any case in which the Secretary 
determines that an entity has failed to comply with subsection 
(c) regarding a project of research described in subsection 
(b), the Secretary--
            (1) shall require that, as a condition of receiving 
        assistance, the entity disclose the existence of a 
        financial interest (as defined under subsection (a)) in 
        each public presentation of the results of such 
        project; and
            (2) may take such other actions as the Secretary 
        determines to be appropriate.
    (f) Definitions.--For purposes of this section:
            (1) The term ``financial interest'' includes the 
        receipt of consulting fees or honoraria and the 
        ownership of stock or equity.
            (2) The term ``assistance'', with respect to 
        conducting a project of research, means a grant, 
        contract, or cooperative agreement.
                 research on public health emergencies
    Sec. 494. [289c] If the Secretary determines, after 
consultation with the Director of NIH, the Commissioner of the 
Food and Drug Administration, or the Director of the Centers 
for Disease Control and Prevention, that a disease or disorder 
constitutes a public health emergency, the Secretary, acting 
through the Director of NIH--
            (1) shall expedite the review by advisory councils 
        under section 406 and by peer review groups under 
        section 492 of applications for grants for research on 
        such disease or disorder or proposals for contracts for 
        such research;
            (2) shall exercise the authority in section 3709 of 
        the Revised Statutes (41 U.S.C. 5) respecting public 
        exigencies to waive the advertising requirements of 
        such section in the case of proposals for contracts for 
        such research;
            (3) may provide administrative supplemental 
        increases in existing grants and contracts to support 
        new research relevant to such disease or disorder; and
            (4) shall disseminate, to health professionals and 
        the public, information on the cause, prevention, and 
        treatment of such disease or disorder that has been 
        developed in research assisted under this section.
The amount of an increase in a grant or contract provided under 
paragraph (3) may not exceed one-half the original amount of 
the grant or contract.
      collaborative use of certain health services research funds
    Sec. 494A. [289c-1] The Secretary shall ensure that amounts 
made available under subparts 14, 15 and 16 of part C for 
health services research relating to alcohol abuse and 
alcoholism, drug abuse and mental health be used 
collaboratively, as appropriate, and in consultation with the 
Agency for Health Care Policy Research.
                          animals in research
    Sec. 495. [289d] (a) The Secretary, acting through the 
Director of NIH, shall establish guidelines for the following:
            (1) The proper care of animals to be used in 
        biomedical and behavioral research.
            (2) The proper treatment of animals while being 
        used in such research. Guidelines under this paragraph 
        shall require--
                    (A) the appropriate use of tranquilizers, 
                analgesics, anesthetics, paralytics, and 
                euthanasia for animals in such research; and
                    (B) appropriate pre-surgical and post-
                surgical veterinary medical and nursing care 
                for animals in such research.
        Such guidelines shall not be construed to prescribe 
        methods of research.
            (3) The organization and operation of animal care 
        committees in accordance with subsection (b).
    (b)(1) Guidelines of the Secretary under subsection (a)(3) 
shall require animal care committees at each entity which 
conducts biomedical and behavioral research with funds provided 
under this Act (including the National Institutes of Health and 
the national research institutes) to assure compliance with the 
guidelines established under subsection (a).
    (2) Each animal care committee shall be appointed by the 
chief executive officer of the entity for which the committee 
is established, shall be composed of not fewer than three 
members, and shall include at least one individual who has no 
association with such entity and at least one doctor of 
veterinary medicine.
    (3) Each animal care committee of a research entity shall--
            (A) review the care and treatment of animals in all 
        animal study areas and facilities of the research 
        entity at least semi-annually to evaluate compliance 
        with applicable guidelines established under subsection 
        (a) for appropriate animal care and treatment;
            (B) keep appropriate records of reviews conducted 
        under subparagraph (A); and
            (C) for each review conducted under subparagraph 
        (A), file with the Director of NIH at least annually 
        (i) a certification that the review has been conducted, 
        and (ii) reports of any violations of guidelines 
        established under subsection (a) or assurances required 
        under paragraph (1) which were observed in such review 
        and which have continued after notice by the committee 
        to the research entity involved of the violations.
Reports filed under subparagraph (C) shall include any minority 
views filed by members of the committee.
    (c) The Director of NIH shall require each applicant for a 
grant, contract, or cooperative agreement involving research on 
animals which is administered by the National Institutes of 
Health or any national research institute to include in its 
application or contract proposal, submitted after the 
expiration of the twelve-month period beginning on the date of 
enactment of this section--
            (1) assurances satisfactory to the Director of NIH 
        that--
                    (A) the applicant meets the requirements of 
                the guidelines established under paragraphs (1) 
                and (2) of subsection (a) and has an animal 
                care committee which meets the requirements of 
                subsection (b); and
                    (B) scientists, animal technicians, and 
                other personnel involved with animal care, 
                treatment, and use by the applicant have 
                available to them instruction or training in 
                the humane practice of animal maintenance and 
                experimentation, and the concept, availability, 
                and use of research or testing methods that 
                limit the use of animals or limit animal 
                distress; and
            (2) a statement of the reasons for the use of 
        animals in the research to be conducted with funds 
        provided under such grant or contract.
Notwithstanding subsection (a)(2) of section 553 of title 5, 
United States Code, regulations under this subsection shall be 
promulgated in accordance with the notice and comment 
requirements of such section.
    (d) If the Director of NIH determines that--
            (1) the conditions of animal care, treatment, or 
        use in an entity which is receiving a grant, contract, 
        or cooperative agreement involving research on animals 
        under this title do not meet applicable guidelines 
        established under subsection (a);
            (2) the entity has been notified by the Director of 
        NIH of such determination and has been given a 
        reasonable opportunity to take corrective action; and
            (3) no action has been taken by the entity to 
        correct such conditions;
the Director of NIH shall suspend or revoke such grant or 
contract under such conditions as the Director determines 
appropriate.
    (e) No guideline or regulation promulgated under subsection 
(a) or (c) may require a research entity to disclose publicly 
trade secrets or commercial or financial information which is 
privileged or confidential.
                 use of appropriations under this title
    Sec. 496. [289e] (a) Appropriations to carry out the 
purposes of this title, unless otherwise expressly provided, 
may be expended in the District of Columbia for--
            (1) personal services;
            (2) stenographic recording and translating 
        services;
            (3) travel expenses (including the expenses of 
        attendance at meetings when specifically authorized by 
        the Secretary);
            (4) rental;
            (5) supplies and equipment;
            (6) purchase and exchange of medical books, books 
        of reference, directories, periodicals, newspapers, and 
        press clippings;
            (7) purchase, operation, and maintenance of 
        passenger motor vehicles;
            (8) printing and binding (in addition to that 
        otherwise provided by law); and
            (9) all other necessary expenses in carrying out 
        this title.
Such appropriations may be expended by contract if deemed 
necessary, without regard to section 3709 of the Revised 
Statutes (41 U.S.C. 5).
    (b)(1) None of the amounts appropriated under this Act for 
the purposes of this title may be obligated for the 
construction of facilities (including the acquisition of land) 
unless a provision of this title establishes express authority 
for such purpose and unless the Act making appropriations under 
such provision specifies that the amounts appropriated are 
available for such purpose.
    (2) Any grants, cooperative agreements, or contracts 
authorized in this title for the construction of facilities may 
be awarded only on a competitive basis.
                                 gifts
    Sec. 497. [289f] The Secretary may, in accordance with 
section 231, accept conditional gifts for the National 
Institutes of Health or a national research institute or for 
the acquisition of grounds or for the erection, equipment, or 
maintenance of facilities for the National Institutes of Health 
or a national research institute. Donations of $50,000 or over 
for the National Institutes of Health or a national research 
institute for carrying out the purposes of this title may be 
acknowledged by the establishment within the National 
Institutes of Health or a national research institute of 
suitable memorials to the donors.
                             fetal research
    Sec. 498. [289g] (a) The Secretary may not conduct or 
support any research or experimentation, in the United States 
or in any other country, on a nonviable living human fetus ex 
utero or a living human fetus ex utero for whom viability has 
not been ascertained unless the research or experimentation--
          may enhance the well-being or meet the health needs 
        of the fetus or enhance the probability of its survival 
        to viability; or
            (2) will pose no added risk of suffering, injury, 
        or death to the fetus and the purpose of the research 
        or experimentation is the development of important 
        biomedical knowledge which cannot be obtained by other 
        means.
    (b) In administering the regulations for the protection of 
human research subjects which--
            (1) apply to research conducted or supported by the 
        Secretary;
            (2) involve living human fetuses in utero; and
            (3) are published in section 46.208 of part 46 of 
        title 45 of the Code of Federal Regulations;
or any successor to such regulations, the Secretary shall 
require that the risk standard (published in section 46.102(g) 
of such part 46 or any successor to such regulations) be the 
same for fetuses which are intended to be aborted and fetuses 
which are intended to be carried to term.
              research on transplantation of fetal tissue
    Sec. 498A. [289g-1] (a) Establishment of Program.--
            (1) In general.--The Secretary may conduct or 
        support research on the transplantation of human fetal 
        tissue for therapeutic purposes.
            (2) Source of tissue.--Human fetal tissue may be 
        used in research carried out under paragraph (1) 
        regardless of whether the tissue is obtained pursuant 
        to a spontaneous or induced abortion or pursuant to a 
        stillbirth.
    (b) Informed Consent of Donor.--
            (1) In general.--In research carried out under 
        subsection (a), human fetal tissue may be used only if 
        the woman providing the tissue makes a statement, made 
        in writing and signed by the woman, declaring that--
                    (A) the woman donates the fetal tissue for 
                use in research described in subsection (a);
                    (B) the donation is made without any 
                restriction regarding the identity of 
                individuals who may be the recipients of 
                transplantations of the tissue; and
                    (C) the woman has not been informed of the 
                identity of any such individuals.
            (2) Additional statement.--In research carried out 
        under subsection (a), human fetal tissue may be used 
        only if the attending physician with respect to 
        obtaining the tissue from the woman involved makes a 
        statement, made in writing and signed by the physician, 
        declaring that--
                    (A) in the case of tissue obtained pursuant 
                to an induced abortion--
                            (i) the consent of the woman for 
                        the abortion was obtained prior to 
                        requesting or obtaining consent for a 
                        donation of the tissue for use in such 
                        research;
                            (ii) no alteration of the timing, 
                        method, or procedures used to terminate 
                        the pregnancy was made solely for the 
                        purposes of obtaining the tissue; and
                            (iii) the abortion was performed in 
                        accordance with applicable State law;
                    (B) the tissue has been donated by the 
                woman in accordance with paragraph (1); and
                    (C) full disclosure has been provided to 
                the woman with regard to--
                            (i) such physician's interest, if 
                        any, in the research to be conducted 
                        with the tissue; and
                            (ii) any known medical risks to the 
                        woman or risks to her privacy that 
                        might be associated with the donation 
                        of the tissue and that are in addition 
                        to risks of such type that are 
                        associated with the woman's medical 
                        care.
    (c) Informed Consent of Researcher and Donee.--In research 
carried out under subsection (a), human fetal tissue may be 
used only if the individual with the principal responsibility 
for conducting the research involved makes a statement, made in 
writing and signed by the individual, declaring that the 
individual--
            (1) is aware that--
                    (A) the tissue is human fetal tissue;
                    (B) the tissue may have been obtained 
                pursuant to a spontaneous or induced abortion 
                or pursuant to a stillbirth; and
                    (C) the tissue was donated for research 
                purposes;
            (2) has provided such information to other 
        individuals with responsibilities regarding the 
        research;
            (3) will require, prior to obtaining the consent of 
        an individual to be a recipient of a transplantation of 
        the tissue, written acknowledgment of receipt of such 
        information by such recipient; and
            (4) has had no part in any decisions as to the 
        timing, method, or procedures used to terminate the 
        pregnancy made solely for the purposes of the research.
    (d) Availability of Statements for Audit.--
            (1) In general.--In research carried out under 
        subsection (a), human fetal tissue may be used only if 
        the head of the agency or other entity conducting the 
        research involved certifies to the Secretary that the 
        statements required under subsections (b)(2) and (c) 
        will be available for audit by the Secretary.
            (2) Confidentiality of audit.--Any audit conducted 
        by the Secretary pursuant to paragraph (1) shall be 
        conducted in a confidential manner to protect the 
        privacy rights of the individuals and entities involved 
        in such research, including such individuals and 
        entities involved in the donation, transfer, receipt, 
        or transplantation of human fetal tissue. With respect 
        to any material or information obtained pursuant to 
        such audit, the Secretary shall--
                    (A) use such material or information only 
                for the purposes of verifying compliance with 
                the requirements of this section;
                    (B) not disclose or publish such material 
                or information, except where required by 
                Federal law, in which case such material or 
                information shall be coded in a manner such 
                that the identities of such individuals and 
                entities are protected; and
                    (C) not maintain such material or 
                information after completion of such audit, 
                except where necessary for the purposes of such 
                audit.
    (e) Applicability of State and Local Law.--
            (1) Research conducted by recipients of 
        assistance.--The Secretary may not provide support for 
        research under subsection (a) unless the applicant for 
        the financial assistance involved agrees to conduct the 
        research in accordance with applicable State law.
            (2) Research conducted by secretary.--The Secretary 
        may conduct research under subsection (a) only in 
        accordance with applicable State and local law.
    (f) Report.--The Secretary shall annually submit to the 
Committee on Energy and Commerce of the House of 
Representatives, and to the Committee on Labor and Human 
Resources of the Senate, a report describing the activities 
carried out under this section during the preceding fiscal 
year, including a description of whether and to what extent 
research under subsection (a) has been conducted in accordance 
with this section.
    (g) Definition.--For purposes of this section, the term 
``human fetal tissue'' means tissue or cells obtained from a 
dead human embryo or fetus after a spontaneous or induced 
abortion, or after a stillbirth.
               prohibitions regarding human fetal tissue
    Sec. 498B. [289g-2] (a) Purchase of Tissue.--It shall be 
unlawful for any person to knowingly acquire, receive, or 
otherwise transfer any human fetal tissue for valuable 
consideration if the transfer affects interstate commerce.
    (b) Solicitation or Acceptance of Tissue as Directed 
Donation for Use in Transplantation.--It shall be unlawful for 
any person to solicit or knowingly acquire, receive, or accept 
a donation of human fetal tissue for the purpose of 
transplantation of such tissue into another person if the 
donation affects interstate commerce, the tissue will be or is 
obtained pursuant to an induced abortion, and--
            (1) the donation will be or is made pursuant to a 
        promise to the donating individual that the donated 
        tissue will be transplanted into a recipient specified 
        by such individual;
            (2) the donated tissue will be transplanted into a 
        relative of the donating individual; or
            (3) the person who solicits or knowingly acquires, 
        receives, or accepts the donation has provided valuable 
        consideration for the costs associated with such 
        abortion.
    (c) Solicitation or Acceptance of Tissue From Fetuses 
Gestated for Research Purposes.--It shall be unlawful for any 
person or entity involved or engaged in interstate commerce 
to--
            (1) solicit or knowingly acquire, receive, or 
        accept a donation of human fetal tissue knowing that a 
        human pregnancy was deliberately initiated to provide 
        such tissue; or
            (2) knowingly acquire, receive, or accept tissue or 
        cells obtained from a human embryo or fetus that was 
        gestated in the uterus of a nonhuman animal.
    (d) Criminal Penalties for Violations.--
            (1) In general.--Any person who violates subsection 
        (a), (b), or (c) shall be fined in accordance with 
        title 18, United States Code, subject to paragraph (2), 
        or imprisoned for not more than 10 years, or both.
            (2) Penalties applicable to persons receiving 
        consideration.--With respect to the imposition of a 
        fine under paragraph (1), if the person involved 
        violates subsection (a) or (b)(3), a fine shall be 
        imposed in an amount not less than twice the amount of 
        the valuable consideration received.
    (e) Definitions.--For purposes of this section:
            (1) The term ``human fetal tissue'' has the meaning 
        given such term in section 498A(g).
            (2) The term ``interstate commerce'' has the 
        meaning given such term in section 201(b) of the 
        Federal Food, Drug, and Cosmetic Act.
            (3) The term ``valuable consideration'' does not 
        include reasonable payments associated with the 
        transportation, implantation, processing, preservation, 
        quality control, or storage of human fetal tissue.

SEC. 498C. [289G-3] BREAST IMPLANT RESEARCH.

    (a) In General.--The Director of NIH may conduct or support 
research to examine the long-term health implications of 
silicone breast implants, both gel and saline filled. Such 
research studies may include the following:
            (1) Developing and examining techniques to measure 
        concentrations of silicone in body fluids and tissues.
            (2) Surveillance of recipients of silicone breast 
        implants, including long-term outcomes and local 
        complications.
    (b) Definition.--For purposes of this section, the term 
``breast implant'' means a breast prosthesis that is implanted 
to augment or reconstruct the female breast.

SEC. 498D. [289G-4] SUPPORT FOR EMERGENCY MEDICINE RESEARCH.

    (a) Emergency Medical Research.--The Secretary shall 
support Federal programs administered by the National 
Institutes of Health, the Agency for Healthcare Research and 
Quality, the Health Resources and Services Administration, the 
Centers for Disease Control and Prevention, and other agencies 
involved in improving the emergency care system to expand and 
accelerate research in emergency medical care systems and 
emergency medicine, including--
            (1) the basic science of emergency medicine;
            (2) the model of service delivery and the 
        components of such models that contribute to enhanced 
        patient health outcomes;
            (3) the translation of basic scientific research 
        into improved practice; and
            (4) the development of timely and efficient 
        delivery of health services.
    (b) Pediatric Emergency Medical Research.--The Secretary 
shall support Federal programs administered by the National 
Institutes of Health, the Agency for Healthcare Research and 
Quality, the Health Resources and Services Administration, the 
Centers for Disease Control and Prevention, and other agencies 
to coordinate and expand research in pediatric emergency 
medical care systems and pediatric emergency medicine, 
including--
            (1) an examination of the gaps and opportunities in 
        pediatric emergency care research and a strategy for 
        the optimal organization and funding of such research;
            (2) the role of pediatric emergency services as an 
        integrated component of the overall health system;
            (3) system-wide pediatric emergency care planning, 
        preparedness, coordination, and funding;
            (4) pediatric training in professional education; 
        and
            (5) research in pediatric emergency care, 
        specifically on the efficacy, safety, and health 
        outcomes of medications used for infants, children, and 
        adolescents in emergency care settings in order to 
        improve patient safety.
    (c) Impact Research.--The Secretary shall support research 
to determine the estimated economic impact of, and savings that 
result from, the implementation of coordinated emergency care 
systems.
    (d) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section such sums as may 
be necessary for each of fiscal years 2010 through 2014.

        PART I--FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH

SEC. 499. [290B] ESTABLISHMENT AND DUTIES OF FOUNDATION.

    (a) In General.--The Secretary shall, acting through the 
Director of NIH, establish a nonprofit corporation to be known 
as the Foundation for the National Institutes of Health 
(hereafter in this section referred to as the ``Foundation''). 
The Foundation shall not be an agency or instrumentality of the 
United States Government.
    (b) Purpose of Foundation.--The purpose of the Foundation 
shall be to support the National Institutes of Health in its 
mission (including collection of funds for pediatric 
pharmacologic research), and to advance collaboration with 
biomedical researchers from universities, industry, and 
nonprofit organizations.
    (c) Certain Activities of Foundation.--
            (1) In general.--In carrying out subsection (b), 
        the Foundation may solicit and accept gifts, grants, 
        and other donations, establish accounts, and invest and 
        expend funds in support of the following activities 
        with respect to the purpose described in such 
        subsection:
                    (A) A program to provide and administer 
                endowed positions that are associated with the 
                research program of the National Institutes of 
                Health. Such endowments may be expended for the 
                compensation of individuals holding the 
                positions, for staff, equipment, quarters, 
                travel, and other expenditures that are 
                appropriate in supporting the endowed 
                positions.
                    (B) A program to provide and administer 
                fellowships and grants to research personnel in 
                order to work and study in association with the 
                National Institutes of Health. Such fellowships 
                and grants may include stipends, travel, health 
                insurance benefits and other appropriate 
                expenses. The recipients of fellowships shall 
                be selected by the donors and the Foundation 
                upon the recommendation of the National 
                Institutes of Health employees in the 
                laboratory where the fellow would serve, and 
                shall be subject to the agreement of the 
                Director of the National Institutes of Health 
                and the Executive Director of the Foundation.
                    (C) A program to collect funds for 
                pediatric pharmacologic research and studies 
                for which the Secretary issues a certification 
                in the affirmative under section 505A(n)(1)(A) 
                of the Federal Food, Drug, and Cosmetic Act.
                    (D) Supplementary programs to provide for--
                            (i) scientists of other countries 
                        to serve in research capacities in the 
                        United States in association with the 
                        National Institutes of Health or 
                        elsewhere, or opportunities for 
                        employees of the National Institutes of 
                        Health or other public health officials 
                        in the United States to serve in such 
                        capacities in other countries, or both;
                            (ii) the conduct and support of 
                        studies, projects, and research, which 
                        may include stipends, travel and other 
                        support for personnel in collaboration 
                        with national and international non-
                        profit and for-profit organizations;
                            (iii) the conduct and support of 
                        forums, meetings, conferences, courses, 
                        and training workshops that may include 
                        undergraduate, graduate, post-graduate, 
                        and post-doctoral accredited courses 
                        and the maintenance of accreditation of 
                        such courses by the Foundation at the 
                        State and national level for college or 
                        continuing education credits or for 
                        degrees;
                            (iv) programs to support and 
                        encourage teachers and students of 
                        science at all levels of education and 
                        programs for the general public which 
                        promote the understanding of science;
                            (v) programs for writing, editing, 
                        printing, publishing, and vending of 
                        books and other materials; and
                            (vi) the conduct of other 
                        activities to carry out and support the 
                        purpose described in subsection (b).
                    (E) The Cures Acceleration Network 
                described in section 402C.
            (2) Fees.--The Foundation may assess fees for the 
        provision of professional, administrative and 
        management services by the Foundation in amounts 
        determined reasonable and appropriate by the Executive 
        Director.
            (3) Authority of foundation.--The Foundation shall 
        be the sole entity responsible for carrying out the 
        activities described in this subsection.
    (d) Board of Directors.--
            (1) Composition.--
                    (A) The Foundation shall have a Board of 
                Directors (hereafter referred to in this 
                section as the ``Board''), which shall be 
                composed of ex officio and appointed members in 
                accordance with this subsection. All appointed 
                members of the Board shall be voting members.
                    (B) The ex officio members of the Board 
                shall be--
                            (i) the Chairman and ranking 
                        minority member of the Subcommittee on 
                        Health and the Environment (Committee 
                        on Energy and Commerce) or their 
                        designees, in the case of the House of 
                        Representatives;
                            (ii) the Chairman and ranking 
                        minority member of the Committee on 
                        Labor and Human Resources or their 
                        designees, in the case of the Senate;
                            (iii) the Director of the National 
                        Institutes of Health; and
                            (iv) the Commissioner of Food and 
                        Drugs.
                    (C) The ex officio members of the Board 
                under subparagraph (B) shall appoint to the 
                Board individuals from among a list of 
                candidates to be provided by the National 
                Academy of Science. Such appointed members 
                shall include--
                            (i) representatives of the general 
                        biomedical field;
                            (ii) representatives of experts in 
                        pediatric medicine and research;
                            (iii) representatives of the 
                        general biobehavioral field, which may 
                        include experts in biomedical ethics; 
                        and
                            (iv) representatives of the general 
                        public, which may include 
                        representatives of affected industries.
                    (D)(i) Not later than 30 days after the 
                date of the enactment of the National 
                Institutes of Health Revitalization Act of 
                1993, the Director of the National Institutes 
                of Health shall convene a meeting of the ex 
                officio members of the Board to--
                            (I) incorporate the Foundation and 
                        establish the general policies of the 
                        Foundation for carrying out the 
                        purposes of subsection (b), including 
                        the establishment of the bylaws of the 
                        Foundation; and
                            (II) appoint the members of the 
                        Board in accordance with subparagraph 
                        (C).
                            (ii) Upon the appointment of the 
                        appointed members of the Board under 
                        clause (i)(II), the terms of service as 
                        members of the Board of the ex officio 
                        members of the Board described in 
                        clauses (i) and (ii) of subparagraph 
                        (B) shall terminate. The ex officio 
                        members of the Board described in 
                        clauses (iii) and (iv) of subparagraph 
                        (B) shall continue to serve as ex 
                        officio members of the Board.
                    (E) The agreement of not less than three-
                fifths of the members of the ex officio members 
                of the Board shall be required for the 
                appointment of each member to the initial 
                Board.
                    (F) No employee of the National Institutes 
                of Health shall be appointed as a member of the 
                Board.
                    (G) The Board may, through amendments to 
                the bylaws of the Foundation, provide that the 
                number of appointed members of the Board shall 
                be greater than the number specified in 
                subparagraph (C).
            (2) Chair.--
                    (A) The ex officio members of the Board 
                under paragraph (1)(B) shall designate an 
                individual to serve as the initial Chair of the 
                Board.
                    (B) Upon the termination of the term of 
                service of the initial Chair of the Board, the 
                appointed members of the Board shall elect a 
                member of the Board to serve as the Chair of 
                the Board.
            (3) Terms and vacancies.--
                    (A) The term of office of each member of 
                the Board appointed under paragraph (1)(C) 
                shall be 5 years, except that the terms of 
                offices for the initial appointed members of 
                the Board shall expire as determined by the ex 
                officio members and the Chair.
                    (B) Any vacancy in the membership of the 
                appointed members of the Board shall be filled 
                in accordance with the bylaws of the Foundation 
                established in accordance with paragraph (6), 
                and shall not affect the power of the remaining 
                appointed members to execute the duties of the 
                Board.
                    (C) If a member of the Board does not serve 
                the full term applicable under subparagraph 
                (A), the individual appointed to fill the 
                resulting vacancy shall be appointed for the 
                remainder of the term of the predecessor of the 
                individual.
                    (D) A member of the Board may continue to 
                serve after the expiration of the term of the 
                member until a successor is appointed.
            (4) Compensation.--Members of the Board may not 
        receive compensation for service on the Board. Such 
        members may be reimbursed for travel, subsistence, and 
        other necessary expenses incurred in carrying out the 
        duties of the Board, as set forth in the bylaws issued 
        by the Board.
            (5) Meetings and quorum.--A majority of the 
        appointed members of the Board shall constitute a 
        quorum for purposes of conducting the business of the 
        Board.
            (6) Certain bylaws.--
                    (A) In establishing bylaws under this 
                subsection, the Board shall ensure that the 
                following are provided for:
                            (i) Policies for the selection of 
                        the officers, employees, agents, and 
                        contractors of the Foundation.
                            (ii) Policies, including ethical 
                        standards, for the acceptance, 
                        solicitation, and disposition of 
                        donations and grants to the Foundation 
                        and for the disposition of the assets 
                        of the Foundation. Policies with 
                        respect to ethical standards shall 
                        ensure that officers, employees and 
                        agents of the Foundation (including 
                        members of the Board) avoid 
                        encumbrances that would result in a 
                        conflict of interest, including a 
                        financial conflict of interest or a 
                        divided allegiance. Such policies shall 
                        include requirements for the provision 
                        of information concerning any ownership 
                        or controlling interest in entities 
                        related to the activities of the 
                        Foundation by such officers, employees 
                        and agents and their spouses and 
                        relatives.
                            (iii) Policies for the conduct of 
                        the general operations of the 
                        Foundation.
                            (iv) Policies for writing, editing, 
                        printing, publishing, and vending of 
                        books and other materials.
                    (B) In establishing bylaws under this 
                subsection, the Board shall ensure that such 
                bylaws (and activities carried out under the 
                bylaws) do not--
                            (i) reflect unfavorably upon the 
                        ability of the Foundation or the 
                        National Institutes of Health to carry 
                        out its responsibilities or official 
                        duties in a fair and objective manner; 
                        or
                            (ii) compromise, or appear to 
                        compromise, the integrity of any 
                        governmental agency or program, or any 
                        officer or employee involved in such 
                        program.
    (e) Incorporation.--The initial members of the Board shall 
serve as incorporators and shall take whatever actions 
necessary to incorporate the Foundation.
    (f) Nonprofit status.--The Foundation shall be considered 
to be a corporation under section 501(c) of the Internal 
Revenue Code of 1986, and shall be subject to the provisions of 
such section.
    (g) Executive Director.--
            (1) In general.--The Foundation shall have an 
        Executive Director who shall be appointed by the Board 
        and shall serve at the pleasure of the Board. The 
        Executive Director shall be responsible for the day-to-
        day operations of the Foundation and shall have such 
        specific duties and responsibilities as the Board shall 
        prescribe.
            (2) Compensation.--The rate of compensation of the 
        Executive Director shall be fixed by the Board.
    (h) Powers.--In carrying out subsection (b), the Foundation 
may--
            (1) operate under the direction of its Board;
            (2) adopt, alter, and use a corporate seal, which 
        shall be judicially noticed;
            (3) provide for 1 or more officers, employees, and 
        agents, as may be necessary, define their duties, and 
        require surety bonds or make other provisions against 
        losses occasioned by acts of such persons;
            (4) hire, promote, compensate, and discharge 
        officers and employees of the Foundation, and define 
        the duties of the officers and employees;
            (5) with the consent of any executive department or 
        independent agency, use the information, services, 
        staff, and facilities of such in carrying out this 
        section;
            (6) sue and be sued in its corporate name, and 
        complain and defend in courts of competent 
        jurisdiction;
            (7) modify or consent to the modification of any 
        contract or agreement to which it is a party or in 
        which it has an interest under this part;
            (8) establish a process for the selection of 
        candidates for positions under subsection (c);
            (9) enter into contracts with public and private 
        organizations for the writing, editing, printing, and 
        publishing of books and other material;
            (10) take such action as may be necessary to obtain 
        patents and licenses for devices and procedures 
        developed by the Foundation and its employees;
            (11) solicit, accept, hold, administer, invest, and 
        spend any gift, devise, or bequest of real or personal 
        property made to the Foundation;
            (12) enter into such other contracts, leases, 
        cooperative agreements, and other transactions as the 
        Executive Director considers appropriate to conduct the 
        activities of the Foundation;
            (13) appoint other groups of advisors as may be 
        determined necessary from time to time to carry out the 
        functions of the Foundation;
            (14) enter into such other contracts, leases, 
        cooperative agreements, and other transactions as the 
        Executive Director considers appropriate to conduct the 
        activities of the Foundation; and
            (15) exercise other powers as set forth in this 
        section, and such other incidental powers as are 
        necessary to carry out its powers, duties, and 
        functions in accordance with this part.
    (i) Administrative Control.--No participant in the program 
established under this part shall exercise any administrative 
control over any Federal employee.
            (7) in paragraphs (1) and (2) of subsection (j) (as 
        so redesignated), by striking ``(including those 
        developed under subsection (d)(2)(B)(i)(II))'' each 
        place it appears.
    (j) General Provisions.--
            (1) Foundation integrity.--The members of the Board 
        shall be accountable for the integrity of the 
        operations of the Foundation and shall ensure such 
        integrity through the development and enforcement of 
        criteria and procedures relating to standards of 
        conduct, financial disclosure statements, conflict of 
        interest rules, recusal and waiver rules, audits and 
        other matter determined appropriate by the Board.
            (2) Financial conflicts of interest.--Any 
        individual who is an officer, employee, or member of 
        the Board of the Foundation may not (in accordance with 
        policies and requirements developed under subsection 
        (d)(6)) \1\ personally or substantially participate in 
        the consideration or determination by the Foundation of 
        any matter that would directly or predictably affect 
        any financial interest of the individual or a relative 
        (as such term is defined in section 109(16) of the 
        Ethics in Government Act of 1978) of the individual, of 
        any business organization or other entity, or of which 
        the individual is an officer or employee, or is 
        negotiating for employment, or in which the individual 
        has any other financial interest.
---------------------------------------------------------------------------
    \1\ Section 13(7) of Public Law 107-109 (115 Stat. 1419) provided 
that paragraphs (1) and (2) of section 499(j) are amended ``by striking 
`(including those developed under subsection (d)(2)(B)(i)(II))' each 
place it appears''. The term to be struck appeared in paragraph (1), 
but not in paragraph (2).
---------------------------------------------------------------------------
            (3) Audits; availability of records.--The 
        Foundation shall--
                    (A) provide for annual audits of the 
                financial condition of the Foundation; and
                    (B) make such audits, and all other 
                records, documents, and other papers of the 
                Foundation, available to the Secretary and the 
                Comptroller General of the United States for 
                examination or audit.
            (4) Reports.--
                    (A) Not later than 5 months following the 
                end of each fiscal year, the Foundation shall 
                publish a report describing the activities of 
                the Foundation during the preceding fiscal 
                year. Each such report shall include for the 
                fiscal year involved a comprehensive statement 
                of the operations, activities, financial 
                condition, and accomplishments of the 
                Foundation, including an accounting of the use 
                of amounts transferred under subsection (l).
                    (B) With respect to the financial condition 
                of the Foundation, each report under 
                subparagraph (A) shall include the source, and 
                a description of, all gifts or grants to the 
                Foundation of real or personal property, and 
                the source and amount of all gifts or grants to 
                the Foundation of money. Each such report shall 
                include a specification of any restrictions on 
                the purposes for which gifts or grants to the 
                Foundation may be used.
                    (C) The Foundation shall make copies of 
                each report submitted under subparagraph (A) 
                available--
                            (i) for public inspection, and 
                        shall upon request provide a copy of 
                        the report to any individual for a 
                        charge that shall not exceed the cost 
                        of providing the copy; and
                            (ii) to the appropriate committees 
                        of Congress.
                    (D) The Board shall annually hold a public 
                meeting to summarize the activities of the 
                Foundation and distribute written reports 
                concerning such activities and the scientific 
                results derived from such activities.
            (5) Service of federal employees.--Federal 
        employees may serve on committees advisory to the 
        Foundation and otherwise cooperate with and assist the 
        Foundation in carrying out its function, so long as the 
        employees do not direct or control Foundation 
        activities.
            (6) Relationship with existing entities.--The 
        Foundation may, pursuant to appropriate agreements, 
        merge with, acquire, or use the resources of existing 
        nonprofit private corporations with missions similar to 
        the purposes of the Foundation, such as the Foundation 
        for Advanced Education in the Sciences.
            (7) Intellectual property rights.--The Board shall 
        adopt written standards with respect to the ownership 
        of any intellectual property rights derived from the 
        collaborative efforts of the Foundation prior to the 
        commencement of such efforts.
            (8) National institutes of health amendments of 
        1990.--The activities conducted in support of the 
        National Institutes of Health Amendments of 1990 
        (Public Law 101-613), and the amendments made by such 
        Act, shall not be nullified by the enactment of this 
        section.
            (9) Limitation of activities.--
                    (A) In general.--The Foundation shall exist 
                solely as an entity to work in collaboration 
                with the research programs of the National 
                Institutes of Health. The Foundation may not 
                undertake activities (such as the operation of 
                independent laboratories or competing for 
                Federal research funds) that are independent of 
                those of the National Institutes of Health 
                research programs.
                    (B) Gifts, grants, and other donations.--
                            (i) In general.--Gifts, grants, and 
                        other donations to the Foundation may 
                        be designated for pediatric research 
                        and studies on drugs, and funds so 
                        designated shall be used solely for 
                        grants for research and studies under 
                        subsection (c)(1)(C).
                            (ii) Other gifts.--Other gifts, 
                        grants, or donations received by the 
                        Foundation and not described in clause 
                        (i) may also be used to support such 
                        pediatric research and studies.
                            (iii) Report.--The recipient of a 
                        grant for research and studies shall 
                        agree to provide the Director of the 
                        National Institutes of Health and the 
                        Commissioner of Food and Drugs, at the 
                        conclusion of the research and 
                        studies--
                                    (I) a report describing the 
                                results of the research and 
                                studies; and
                                    (II) all data generated in 
                                connection with the research 
                                and studies.
                            (iv) Action by the commissioner of 
                        food and drugs.--The Commissioner of 
                        Food and Drugs shall take appropriate 
                        action in response to a report received 
                        under clause (iii) in accordance with 
                        paragraphs (7) through (12) of section 
                        409I(c), including negotiating with the 
                        holders of approved applications for 
                        the drugs studied for any labeling 
                        changes that the Commissioner 
                        determines to be appropriate and 
                        requests the holders to make.
                    (C) Applicability.--Subparagraph (A) does 
                not apply to the program described in 
                subsection (c)(1)(C).
            (10) Transfer of funds.--The Foundation may 
        transfer funds to the National Institutes of Health and 
        the National Institutes of Health may accept transfers 
        of funds from the Foundation. Any funds transferred 
        under this paragraph shall be subject to all Federal 
        limitations relating to federally-funded research.
    (k) Duties of the Director.--
            (1) Applicability of certain standards to non-
        federal employees.--In the case of any individual who 
        is not an employee of the Federal Government and who 
        serves in association with the National Institutes of 
        Health, with respect to financial assistance received 
        from the Foundation, the Foundation may not provide the 
        assistance of, or otherwise permit the work at the 
        National Institutes of Health to begin until a 
        memorandum of understanding between the individual and 
        the Director of the National Institutes of Health, or 
        the designee of such Director, has been executed 
        specifying that the individual shall be subject to such 
        ethical and procedural standards of conduct relating to 
        duties performed at the National Institutes of Health, 
        as the Director of the National Institutes of Health 
        determines is appropriate.
            (2) Support services.--The Director of the National 
        Institutes of Health may provide facilities, utilities 
        and support services to the Foundation if it is 
        determined by the Director to be advantageous to the 
        research programs of the National Institutes of Health.
    (l) Funding.--From amounts appropriated to the National 
Institutes of Health, for each fiscal year, the Director of NIH 
shall transfer not less than $500,000 and not more than 
$1,250,000 to the Foundation.ATTORNEY: CAS (March 29, 
2000) deg.
   TITLE V--SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION

              Part A--Organization and General Authorities

SEC. 501. [290AA] SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES 
                    ADMINISTRATION.

    (a) Establishment.--The Substance Abuse and Mental Health 
Services Administration (hereafter referred to in this title as 
the ``Administration'') is an agency of the Service.
    (b) Agencies.--The following entities are agencies of the 
Administration:
            (1) The Center for Substance Abuse Treatment.
            (2) The Center for Substance Abuse Prevention.
            (3) The Center for Mental Health Services.
    (c) Administrator and Deputy Administrator.--
            (1) Administrator.--The Administration shall be 
        headed by an Administrator (hereinafter in this title 
        referred to as the ``Administrator'') who shall be 
        appointed by the President, by and with the advice and 
        consent of the Senate.
            (2) Deputy Administrator.--The Administrator, with 
        the approval of the Secretary, may appoint a Deputy 
        Administrator and may employ and prescribe the 
        functions of such officers and employees, including 
        attorneys, as are necessary to administer the 
        activities to be carried out through the 
        Administration.
    (d) Authorities.--The Secretary, acting through the 
Administrator, shall--
            (1) supervise the functions of the agencies of the 
        Administration in order to assure that the programs 
        carried out through each such agency receive 
        appropriate and equitable support and that there is 
        cooperation among the agencies in the implementation of 
        such programs;
            (2) establish and implement, through the respective 
        agencies, a comprehensive program to improve the 
        provision of treatment and related services to 
        individuals with respect to substance abuse and mental 
        illness and to improve prevention services, promote 
        mental health and protect the legal rights of 
        individuals with mental illnesses and individuals who 
        are substance abusers;
            (3) carry out the administrative and financial 
        management, policy development and planning, 
        evaluation, knowledge dissemination, and public 
        information functions that are required for the 
        implementation of this title;
            (4) assure that the Administration conduct and 
        coordinate demonstration projects, evaluations, and 
        service system assessments and other activities 
        necessary to improve the availability and quality of 
        treatment, prevention and related services;
            (5) support activities that will improve the 
        provision of treatment, prevention and related 
        services, including the development of national mental 
        health and substance abuse goals and model programs;
            (6) in cooperation with the National Institutes of 
        Health, the Centers for Disease Control and the Health 
        Resources and Services Administration develop 
        educational materials and intervention strategies to 
        reduce the risks of HIV or tuberculosis among substance 
        abusers and individuals with mental illness and to 
        develop appropriate mental health services for 
        individuals with such illnesses;
            (7) coordinate Federal policy with respect to the 
        provision of treatment services for substance abuse 
        utilizing anti-addiction medications, including 
        methadone;
            (8) conduct programs, and assure the coordination 
        of such programs with activities of the National 
        Institutes of Health and the Agency for Health Care 
        Policy Research \1\, as appropriate, to evaluate the 
        process, outcomes and community impact of treatment and 
        prevention services and systems of care in order to 
        identify the manner in which such services can most 
        effectively be provided;
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    \1\ So in law. See section 101(a) of Public Law 102-321 (106 Stat. 
324). Probably should have been ``Agency for Health Care Policy and 
Research''. The Agency, however, was redesignated as the Agency for 
Health Care Policy and Research by Public Law 106-129 (see 113 Stat. 
1653).
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            (9) collaborate with the Director of the National 
        Institutes of Health in the development of a system by 
        which the relevant research findings of the National 
        Institute on Drug Abuse, the National Institute on 
        Alcohol Abuse and Alcoholism, the National Institute of 
        Mental Health, and, as appropriate, the Agency for 
        Health Care Policy Research \1\ are disseminated to 
        service providers in a manner designed to improve the 
        delivery and effectiveness of treatment and prevention 
        services;
            (10) encourage public and private entities that 
        provide health insurance to provide benefits for 
        substance abuse and mental health services;
            (11) promote the integration of substance abuse and 
        mental health services into the mainstream of the 
        health care delivery system of the United States;
            (12) monitor compliance by hospitals and other 
        facilities with the requirements of sections 542 and 
        543;
            (13) with respect to grant programs authorized 
        under this title, assure that--
                    (A) all grants that are awarded for the 
                provision of services are subject to 
                performance and outcome evaluations; and
                    (B) all grants that are awarded to entities 
                other than States are awarded only after the 
                State in which the entity intends to provide 
                services--
                            (i) is notified of the pendency of 
                        the grant application; and
                            (ii) is afforded an opportunity to 
                        comment on the merits of the 
                        application;
            (14) assure that services provided with amounts 
        appropriated under this title are provided bilingually, 
        if appropriate;
            (15) improve coordination among prevention 
        programs, treatment facilities and nonhealth care 
        systems such as employers, labor unions, and schools, 
        and encourage the adoption of employee assistance 
        programs and student assistance programs;
            (16) maintain a clearinghouse for substance abuse 
        and mental health information to assure the widespread 
        dissemination of such information to States, political 
        subdivisions, educational agencies and institutions, 
        treatment providers, and the general public;
            (17) in collaboration with the National Institute 
        on Aging, and in consultation with the National 
        Institute on Drug Abuse, the National Institute on 
        Alcohol Abuse and Alcoholism and the National Institute 
        of Mental Health, as appropriate, promote and evaluate 
        substance abuse services for older Americans in need of 
        such services, and mental health services for older 
        Americans who are seriously mentally ill; and
            (18) promote the coordination of service programs 
        conducted by other departments, agencies, organizations 
        and individuals that are or may be related to the 
        problems of individuals suffering from mental illness 
        or substance abuse, including liaisons with the Social 
        Security Administration, Centers for Medicare & 
        Medicaid Services, and other programs of the 
        Department, as well as liaisons with the Department of 
        Education, Department of Justice, and other Federal 
        Departments and offices, as appropriate.
    (e) Associate Administrator for Alcohol Prevention and 
Treatment Policy.--
            (1) In general.--There may be in the Administration 
        an Associate Administrator for Alcohol Prevention and 
        Treatment Policy to whom the Administrator may delegate 
        the functions of promoting, monitoring, and evaluating 
        service programs for the prevention and treatment of 
        alcoholism and alcohol abuse within the Center for 
        Substance Abuse Prevention, the Center for Substance 
        Abuse Treatment and the Center for Mental Health 
        Services, and coordinating such programs among the 
        Centers, and among the Centers and other public and 
        private entities. The Associate Administrator also may 
        ensure that alcohol prevention, education, and policy 
        strategies are integrated into all programs of the 
        Centers that address substance abuse prevention, 
        education, and policy, and that the Center for 
        Substance Abuse Prevention addresses the Healthy People 
        2010 goals and the National Dietary Guidelines of the 
        Department of Health and Human Services and the 
        Department of Agriculture related to alcohol 
        consumption.
            (2) Plan.--
                    (A) The Administrator, acting through the 
                Associate Administrator for Alcohol Prevention 
                and Treatment Policy, shall develop, and 
                periodically review and as appropriate revise, 
                a plan for programs and policies to treat and 
                prevent alcoholism and alcohol abuse. The plan 
                shall be developed (and reviewed and revised) 
                in collaboration with the Directors of the 
                Centers of the Administration and in 
                consultation with members of other Federal 
                agencies and public and private entities.
                    (B) Not later than 1 year after the date of 
                the enactment of the ADAMHA Reorganization Act, 
                the Administrator shall submit to the Congress 
                the first plan developed under subparagraph 
                (A).
            (3) Report.--
                    (A) Not less than once during each 2 years, 
                the Administrator, acting through the Associate 
                Administrator for Alcohol Prevention and 
                Treatment Policy, shall prepare a report 
                describing the alcoholism and alcohol abuse 
                prevention and treatment programs undertaken by 
                the Administration and its agencies, and the 
                report shall include a detailed statement of 
                the expenditures made for the activities 
                reported on and the personnel used in 
                connection with such activities.
                    (B) Each report under subparagraph (A) 
                shall include a description of any revisions in 
                the plan under paragraph (2) made during the 
                preceding 2 years.
                    (C) Each report under subparagraph (A) 
                shall be submitted to the Administrator for 
                inclusion in the biennial report under 
                subsection (k).
    (f) Associate Administrator for Women's Services.--
            (1) Appointment.--The Administrator, with the 
        approval of the Secretary, shall appoint an Associate 
        Administrator for Women's Services who shall report 
        directly to the Administrator.
            (2) Duties.--The Associate Administrator appointed 
        under paragraph (1) shall--
                    (A) establish a committee to be known as 
                the Coordinating Committee for Women's Services 
                (hereafter in this subparagraph referred to as 
                the ``Coordinating Committee''), which shall be 
                composed of the Directors of the agencies of 
                the Administration (or the designees of the 
                Directors);
                    (B) acting through the Coordinating 
                Committee, with respect to women's substance 
                abuse and mental health services--
                            (i) identify the need for such 
                        services, and make an estimate each 
                        fiscal year of the funds needed to 
                        adequately support the services;
                            (ii) identify needs regarding the 
                        coordination of services;
                            (iii) encourage the agencies of the 
                        Administration to support such 
                        services; and
                            (iv) assure that the unique needs 
                        of minority women, including Native 
                        American, Hispanic, African-American 
                        and Asian women, are recognized and 
                        addressed within the activities of the 
                        Administration; and
                    (C) establish an advisory committee to be 
                known as the Advisory Committee for Women's 
                Services, which shall be composed of not more 
                than 10 individuals, a majority of whom shall 
                be women, who are not officers or employees of 
                the Federal Government, to be appointed by the 
                Administrator from among physicians, 
                practitioners, treatment providers, and other 
                health professionals, whose clinical practice, 
                specialization, or professional expertise 
                includes a significant focus on women's 
                substance abuse and mental health conditions, 
                that shall--
                            (i) advise the Associate 
                        Administrator on appropriate activities 
                        to be undertaken by the agencies of the 
                        Administration with respect to women's 
                        substance abuse and mental health 
                        services, including services which 
                        require a multidisciplinary approach;
                            (ii) collect and review data, 
                        including information provided by the 
                        Secretary (including the material 
                        referred to in paragraph (3)), and 
                        report biannually to the Administrator 
                        regarding the extent to which women are 
                        represented among senior personnel, and 
                        make recommendations regarding 
                        improvement in the participation of 
                        women in the workforce of the 
                        Administration; and
                            (iii) prepare, for inclusion in the 
                        biennial report required pursuant to 
                        subsection (k), a description of 
                        activities of the Committee, including 
                        findings made by the Committee 
                        regarding--
                                    (I) the extent of 
                                expenditures made for women's 
                                substance abuse and mental 
                                health services by the agencies 
                                of the Administration; and
                                    (II) the estimated level of 
                                funding needed for substance 
                                abuse and mental health 
                                services to meet the needs of 
                                women;
                    (D) improve the collection of data on 
                women's health by--
                            (i) reviewing the current data at 
                        the Administration to determine its 
                        uniformity and applicability;
                            (ii) developing standards for all 
                        programs funded by the Administration 
                        so that data are, to the extent 
                        practicable, collected and reported 
                        using common reporting formats, 
                        linkages and definitions; and
                            (iii) reporting to the 
                        Administrator a plan for incorporating 
                        the standards developed under clause 
                        (ii) in all Administration programs and 
                        a plan to assure that the data so 
                        collected are accessible to health 
                        professionals, providers, researchers, 
                        and members of the public; and
                    (E) shall establish, maintain, and operate 
                a program to provide information on women's 
                substance abuse and mental health services.
            (3) Study.--
                    (A) The Secretary, acting through the 
                Assistant Secretary for Personnel, shall 
                conduct a study to evaluate the extent to which 
                women are represented among senior personnel at 
                the Administration.
                    (B) Not later than 90 days after the date 
                of the enactment of the ADAMHA Reorganization 
                Act, the Assistant Secretary for Personnel 
                shall provide the Advisory Committee for 
                Women's Services with a study plan, including 
                the methodology of the study and any sampling 
                frames. Not later than 180 days after such date 
                of enactment, the Assistant Secretary shall 
                prepare and submit directly to the Advisory 
                Committee a report concerning the results of 
                the study conducted under subparagraph (A).
                    (C) The Secretary shall prepare and provide 
                to the Advisory Committee for Women's Services 
                any additional data as requested.
            (4) Office.--Nothing in this subsection shall be 
        construed to preclude the Secretary from establishing 
        within the Substance Abuse and Mental Health 
        Administration an Office of Women's Health.
            (5) Definition.--For purposes of this subsection, 
        the term ``women's substance abuse and mental health 
        conditions'', with respect to women of all age, ethnic, 
        and racial groups, means all aspects of substance abuse 
        and mental illness--
                    (A) unique to or more prevalent among 
                women; or
                    (B) with respect to which there have been 
                insufficient services involving women or 
                insufficient data.
    (g) Services of Experts.--
            (1) In general.--The Administrator may obtain (in 
        accordance with section 3109 of title 5, United States 
        Code, but without regard to the limitation in such 
        section on the number of days or the period of service) 
        the services of not more than 20 experts or consultants 
        who have professional qualifications. Such experts and 
        consultants shall be obtained for the Administration 
        and for each of its agencies.
            (2) Compensation and expenses.--
                    (A) Experts and consultants whose services 
                are obtained under paragraph (1) shall be paid 
                or reimbursed for their expenses associated 
                with traveling to and from their assignment 
                location in accordance with sections 5724, 
                5724a(a), 5724a(c), and 5726(c) of title 5, 
                United States Code.
                    (B) Expenses specified in subparagraph (A) 
                may not be allowed in connection with the 
                assignment of an expert or consultant whose 
                services are obtained under paragraph (1), 
                unless and until the expert or consultant 
                agrees in writing to complete the entire period 
                of assignment or one year, whichever is 
                shorter, unless separated or reassigned for 
                reasons beyond the control of the expert or 
                consultant that are acceptable to the 
                Secretary. If the expert or consultant violates 
                the agreement, the money spent by the United 
                States for the expenses specified in 
                subparagraph (A) is recoverable from the expert 
                or consultant as a debt of the United States. 
                The Secretary may waive in whole or in part a 
                right of recovery under this subparagraph.
    (h) Peer Review Groups.--The Administrator shall, without 
regard to the provisions of title 5, United States Code, 
governing appointments in the competitive service, and without 
regard to the provisions of chapter 51 and subchapter III of 
chapter 53 of such title, relating to classification and 
General Schedule pay rates, establish such peer review groups 
and program advisory committees as are needed to carry out the 
requirements of this title and appoint and pay members of such 
groups, except that officers and employees of the United States 
shall not receive additional compensation for services as 
members of such groups. The Federal Advisory Committee Act 
shall not apply to the duration of a peer review group 
appointed under this subsection.
    (i) Voluntary Services.--The Administrator may accept 
voluntary and uncompensated services.
    (j) Administration.--The Administrator shall ensure that 
programs and activities assigned under this title to the 
Administration are fully administered by the respective Centers 
to which such programs and activities are assigned.
    (k) Report Concerning Activities and Progress.--Not later 
than February 10, 1994, and once every 2 years thereafter, the 
Administrator shall prepare and submit to the Committee on 
Energy and Commerce of the House of Representatives, and to the 
Committee on Labor and Human Resources of the Senate, the 
report containing--
            (1) a description of the activities carried out by 
        the Administration;
            (2) a description of any measurable progress made 
        in improving the availability and quality of substance 
        abuse and mental health services;
            (3) a description of the mechanisms by which 
        relevant research findings of the National Institute on 
        Drug Abuse, the National Institute on Alcohol Abuse and 
        Alcoholism, and the National Institute of Mental Health 
        have been disseminated to service providers or 
        otherwise utilized by the Administration to further the 
        purposes of this title; and
            (4) any report required in this title to be 
        submitted to the Adminstrator \1\ for inclusion in the 
        report under this subsection.
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    \1\ So in law. See section 101(a) of Public Law 102-321 (106 Stat. 
324). Probably should be ``Administrator''.
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    (l) Applications for Grants and Contracts.--With respect to 
awards of grants, cooperative agreements, and contracts under 
this title, the Administrator, or the Director of the Center 
involved, as the case may be, may not make such an award 
unless--
            (1) an application for the award is submitted to 
        the official involved;
            (2) with respect to carrying out the purpose for 
        which the award is to be provided, the application 
        provides assurances of compliance satisfactory to such 
        official; and
            (3) the application is otherwise in such form, is 
        made in such manner, and contains such agreements, 
        assurances, and information as the official determines 
        to be necessary to carry out the purpose for which the 
        award is to be provided.
    (m) Emergency Response.--
            (1) In general.--Notwithstanding section 504 and 
        except as provided in paragraph (2), the Secretary may 
        use not to exceed 2.5 percent of all amounts 
        appropriated under this title for a fiscal year to make 
        noncompetitive grants, contracts or cooperative 
        agreements to public entities to enable such entities 
        to address emergency substance abuse or mental health 
        needs in local communities.
            (2) Exceptions.--Amounts appropriated under part C 
        shall not be subject to paragraph (1).
            (3) Emergencies.--The Secretary shall establish 
        criteria for determining that a substance abuse or 
        mental health emergency exists and publish such 
        criteria in the Federal Register prior to providing 
        funds under this subsection.
    (n) Limitation on the Use of Certain Information.--No 
information, if an establishment or person supplying the 
information or described in it is identifiable, obtained in the 
course of activities undertaken or supported under section 505 
may be used for any purpose other than the purpose for which it 
was supplied unless such establishment or person has consented 
(as determined under regulations of the Secretary) to its use 
for such other purpose. Such information may not be published 
or released in other form if the person who supplied the 
information or who is described in it is identifiable unless 
such person has consented (as determined under regulations of 
the Secretary) to its publication or release in other form.
    (o) Authorization of Appropriations.--For the purpose of 
providing grants, cooperative agreements, and contracts under 
this section, there are authorized to be appropriated 
$25,000,000 for fiscal year 2001, and such sums as may be 
necessary for each of the fiscal years 2002 and 2003.
                           advisory councils
    Sec. 502. [290aa-1] (a) Appointment.--
            (1) In general.--The Secretary shall appoint an 
        advisory council for--
                    (A) the Substance Abuse and Mental Health 
                Services Administration;
                    (B) the Center for Substance Abuse 
                Treatment;
                    (C) the Center for Substance Abuse 
                Prevention; and
                    (D) the Center for Mental Health Services.
        Each such advisory council shall advise, consult with, 
        and make recommendations to the Secretary and the 
        Administrator or Director of the Administration or 
        Center for which the advisory council is established 
        concerning matters relating to the activities carried 
        out by and through the Administration or Center and the 
        policies respecting such activities.
            (2) Function and activities.--An advisory council--
                    (A)(i) may on the basis of the materials 
                provided by the organization respecting 
                activities conducted at the organization, make 
                recommendations to the Administrator or 
                Director of the Administration or Center for 
                which it was established respecting such 
                activities;
                    (ii) shall review applications submitted 
                for grants and cooperative agreements for 
                activities for which advisory council approval 
                is required under section 504(d)(2) and 
                recommend for approval applications for 
                projects that show promise of making valuable 
                contributions to the Administration's mission; 
                and
                    (iii) may review any grant, contract, or 
                cooperative agreement proposed to be made or 
                entered into by the organization;
                    (B) may collect, by correspondence or by 
                personal investigation, information as to 
                studies and services that are being carried on 
                in the United States or any other country as to 
                the diseases, disorders, or other aspects of 
                human health with respect to which the 
                organization was established and with the 
                approval of the Administrator or Director, 
                whichever is appropriate, make such information 
                available through appropriate publications for 
                the benefit of public and private health 
                entities and health professions personnel and 
                for the information of the general public; and
                    (C) may appoint subcommittees and convene 
                workshops and conferences.
    (b) Membership.--
            (1) In general.--Each advisory council shall 
        consist of nonvoting ex officio members and not more 
        than 12 members to be appointed by the Secretary under 
        paragraph (3).
            (2) Ex officio members.--The ex officio members of 
        an advisory council shall consist of--
                    (A) the Secretary;
                    (B) the Administrator;
                    (C) the Director of the Center for which 
                the council is established;
                    (D) the Under Secretary for Health of the 
                Department of Veterans Affairs;
                    (E) the Assistant Secretary for Defense for 
                Health Affairs (or the designates of such 
                officers); and
                    (F) such additional officers or employees 
                of the United States as the Secretary 
                determines necessary for the advisory council 
                to effectively carry out its functions.
            (3) Appointed members.--Individuals shall be 
        appointed to an advisory council under paragraph (1) as 
        follows:
                    (A) Nine of the members shall be appointed 
                by the Secretary from among the leading 
                representatives of the health disciplines 
                (including public health and behavioral and 
                social sciences) relevant to the activities of 
                the Administration or Center for which the 
                advisory council is established.
                    (B) Three of the members shall be appointed 
                by the Secretary from the general public and 
                shall include leaders in fields of public 
                policy, public relations, law, health policy 
                economics, or management.
            (4) Compensation.--Members of an advisory council 
        who are officers or employees of the United States 
        shall not receive any compensation for service on the 
        advisory council. The remaining members of an advisory 
        council shall receive, for each day (including travel 
        time) they are engaged in the performance of the 
        functions of the advisory council, compensation at 
        rates not to exceed the daily equivalent to the annual 
        rate in effect for grade GS-18 of the General Schedule.
    (c) Terms of Office.--
            (1) In general.--The term of office of a member of 
        an advisory council appointed under subsection (b) 
        shall be 4 years, except that any member appointed to 
        fill a vacancy for an unexpired term shall serve for 
        the remainder of such term. The Secretary shall make 
        appointments to an advisory council in such a manner as 
        to ensure that the terms of the members not all expire 
        in the same year. A member of an advisory council may 
        serve after the expiration of such member's term until 
        a successor has been appointed and taken office.
            (2) Reappointments.--A member who has been 
        appointed to an advisory council for a term of 4 years 
        may not be reappointed to an advisory council during 
        the 2-year period beginning on the date on which such 
        4-year term expired.
            (3) Time for appointment.--If a vacancy occurs in 
        an advisory council among the members under subsection 
        (b), the Secretary shall make an appointment to fill 
        such vacancy within 90 days from the date the vacancy 
        occurs.
    (d) Chair.--The Secretary shall select a member of an 
advisory council to serve as the chair of the council. The 
Secretary may so select an individual from among the appointed 
members, or may select the Administrator or the Director of the 
Center involved. The term of office of the chair shall be 2 
years.
    (e) Meetings.--An advisory council shall meet at the call 
of the chairperson or upon the request of the Administrator or 
Director of the Administration or Center for which the advisory 
council is established, but in no event less than 2 times 
during each fiscal year. The location of the meetings of each 
advisory council shall be subject to the approval of the 
Administrator or Director of Administration or Center for which 
the council was established.
    (f) Executive Secretary and Staff.--The Administrator or 
Director of the Administration or Center for which the advisory 
council is established shall designate a member of the staff of 
the Administration or Center for which the advisory council is 
established to serve as the Executive Secretary of the advisory 
council. The Administrator or Director shall make available to 
the advisory council such staff, information, and other 
assistance as it may require to carry out its functions. The 
Administrator or Director shall provide orientation and 
training for new members of the advisory council to provide for 
their effective participation in the functions of the advisory 
council.

          reports on alcoholism, alcohol abuse, and drug abuse

    Sec. 503. [290aa-2] (a) The Secretary shall submit to 
Congress on or before January 15, 1984, and every three years 
thereafter a report--
            (1) containing current information on the health 
        consequences of using alcoholic beverages,
            (2) containing a description of current research 
        findings made with respect to alcohol abuse and 
        alcoholism, and
            (3) containing such recommendations for legislation 
        and administrative action as the Secretary may deem 
        appropriate.
    (b) The Secretary shall submit to Congress on or before 
January 15, 1984, and every three years thereafter a report--
            (1) describing the health consequences and extent 
        of drug abuse in the United States;
            (2) describing current research findings made with 
        respect to drug abuse, including current findings on 
        the health effects of marihuana and the addictive 
        property of tobacco; and
            (3) containing such recommendations for legislation 
        and administrative action as the Secretary may deem 
        appropriate.

SEC. 503A. [290AA-2A] REPORT ON INDIVIDUALS WITH CO-OCCURRING MENTAL 
                    ILLNESS AND SUBSTANCE ABUSE DISORDERS.

    (a) In General.--Not later than 2 years after the date of 
the enactment of this section, the Secretary shall, after 
consultation with organizations representing States, mental 
health and substance abuse treatment providers, prevention 
specialists, individuals receiving treatment services, and 
family members of such individuals, prepare and submit to the 
Committee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Commerce of the House of 
Representatives, a report on prevention and treatment services 
for individuals who have co-occurring mental illness and 
substance abuse disorders.
    (b) Report Content.--The report under subsection (a) shall 
be based on data collected from existing Federal and State 
surveys regarding the treatment of co-occurring mental illness 
and substance abuse disorders and shall include--
            (1) a summary of the manner in which individuals 
        with co-occurring disorders are receiving treatment, 
        including the most up-to-date information available 
        regarding the number of children and adults with co-
        occurring mental illness and substance abuse disorders 
        and the manner in which funds provided under sections 
        1911 and 1921 are being utilized, including the number 
        of such children and adults served with such funds;
            (2) a summary of improvements necessary to ensure 
        that individuals with co-occurring mental illness and 
        substance abuse disorders receive the services they 
        need;
            (3) a summary of practices for preventing substance 
        abuse among individuals who have a mental illness and 
        are at risk of having or acquiring a substance abuse 
        disorder; and
            (4) a summary of evidenced-based practices for 
        treating individuals with co-occurring mental illness 
        and substance abuse disorders and recommendations for 
        implementing such practices.
    (c) Funds for Report.--The Secretary may obligate funds to 
carry out this section with such appropriations as are 
available.

SEC. 504. \1\ [290AA-3] PEER REVIEW.
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    \1\ Section 504 appears according to the probable intent of the 
Congress. Section 3401(b) of Public Law 106-310 (114 Stat. 1218) 
provides that the section ``is amended as follows:''. No amendatory 
instructions were then given, but a substitute text was provided. The 
amendment probably should have instructed that section 504 ``is amended 
to read as follows:''.
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    (a) In General.--The Secretary, after consultation with the 
Administrator, shall require appropriate peer review of grants, 
cooperative agreements, and contracts to be administered 
through the agency which exceed the simple acquisition 
threshold as defined in section 4(11) of the Office of Federal 
Procurement Policy Act.
    (b) Members.--The members of any peer review group 
established under subsection (a) shall be individuals who by 
virtue of their training or experience are eminently qualified 
to perform the review functions of the group. Not more than 
one-fourth of the members of any such peer review group shall 
be officers or employees of the United States.
    (c) Advisory Council Review.--If the direct cost of a grant 
or cooperative agreement (described in subsection (a)) exceeds 
the simple acquisition threshold as defined by section 4(11) of 
the Office of Federal Procurement Policy Act, the Secretary may 
make such a grant or cooperative agreement only if such grant 
or cooperative agreement is recommended--
            (1) after peer review required under subsection 
        (a); and
            (2) by the appropriate advisory council.
    (d) Conditions.--The Secretary may establish limited 
exceptions to the limitations contained in this section 
regarding participation of Federal employees and advisory 
council approval. The circumstances under which the Secretary 
may make such an exception shall be made public.
                          data collection \1\
    Sec. 505. [290aa-4] (a) The Secretary, acting through the 
Administrator, shall collect data each year on--
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    \1\ Section 502 of Public Law 104-237 (110 Stat. 3112) provides as 
follows:
    ``The Secretary of Health and Human Services shall develop a public 
health monitoring program to monitor methamphetamine abuse in the 
United States. The program shall include the collection and 
dissemination of data related to methamphetamine abuse which can be 
used by public health officials in policy development.''.
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            (1) the national incidence and prevalence of the 
        various forms of mental illness and substance abuse; 
        and
            (2) the incidence and prevalence of such various 
        forms in major metropolitan areas selected by the 
        Administrator.
    (b) With respect to the activities of the Administrator 
under subsection (a) relating to mental health, the 
Administrator shall ensure that such activities include, at a 
minimum, the collection of data on--
            (1) the number and variety of public and nonprofit 
        private treatment programs;
            (2) the number and demographic characteristics of 
        individuals receiving treatment through such programs;
            (3) the type of care received by such individuals; 
        and
            (4) such other data as may be appropriate.
    (c)(1) With respect to the activities of the Administrator 
under subsection (a) relating to substance abuse, the 
Administrator shall ensure that such activities include, at a 
minimum, the collection of data on--
            (A) the number of individuals admitted to the 
        emergency rooms of hospitals as a result of the abuse 
        of alcohol or other drugs;
            (B) the number of deaths occurring as a result of 
        substance abuse, as indicated in reports by coroners;
            (C) the number and variety of public and private 
        nonprofit treatment programs, including the number and 
        type of patient slots available;
            (D) the number of individuals seeking treatment 
        through such programs, the number and demographic 
        characteristics of individuals receiving such 
        treatment, the percentage of individuals who complete 
        such programs, and, with respect to individuals 
        receiving such treatment, the length of time between an 
        individual's request for treatment and the commencement 
        of treatment;
            (E) the number of such individuals who return for 
        treatment after the completion of a prior treatment in 
        such programs and the method of treatment utilized 
        during the prior treatment;
            (F) the number of individuals receiving public 
        assistance for such treatment programs;
            (G) the costs of the different types of treatment 
        modalities for drug and alcohol abuse and the aggregate 
        relative costs of each such treatment modality provided 
        within a State in each fiscal year;
            (H) to the extent of available information, the 
        number of individuals receiving treatment for alcohol 
        or drug abuse who have private insurance coverage for 
        the costs of such treatment;
            (I) the extent of alcohol and drug abuse among high 
        school students and among the general population; and
            (J) the number of alcohol and drug abuse counselors 
        and other substance abuse treatment personnel employed 
        in public and private treatment facilities.
    (2) Annual surveys shall be carried out in the collection 
of data under this subsection. Summaries and analyses of the 
data collected shall be made available to the public.
    (d) After consultation with the States and with appropriate 
national organizations, the Administrator shall develop uniform 
criteria for the collection of data, using the best available 
technology, pursuant to this section.

SEC. 506. [290AA-5] GRANTS FOR THE BENEFIT OF HOMELESS INDIVIDUALS.

    (a) In General.--The Secretary shall award grants, 
contracts and cooperative agreements to community-based public 
and private nonprofit entities for the purposes of providing 
mental health and substance abuse services for homeless 
individuals. In carrying out this section, the Secretary shall 
consult with the Interagency Council on the Homeless, 
established under section 201 of the Stewart B. McKinney 
Homeless Assistance Act (42 U.S.C. 11311).
    (b) Preferences.--In awarding grants, contracts, and 
cooperative agreements under subsection (a), the Secretary 
shall give a preference to--
            (1) entities that provide integrated primary 
        health, substance abuse, and mental health services to 
        homeless individuals;
            (2) entities that demonstrate effectiveness in 
        serving runaway, homeless, and street youth;
            (3) entities that have experience in providing 
        substance abuse and mental health services to homeless 
        individuals;
            (4) entities that demonstrate experience in 
        providing housing for individuals in treatment for or 
        in recovery from mental illness or substance abuse; and
            (5) entities that demonstrate effectiveness in 
        serving homeless veterans.
    (c) Services for Certain Individuals.--In awarding grants, 
contracts, and cooperative agreements under subsection (a), the 
Secretary shall not--
            (1) prohibit the provision of services under such 
        subsection to homeless individuals who are suffering 
        from a substance abuse disorder and are not suffering 
        from a mental health disorder; and
            (2) make payments under subsection (a) to any 
        entity that has a policy of--
                    (A) excluding individuals from mental 
                health services due to the existence or 
                suspicion of substance abuse; or
                    (B) has a policy of excluding individuals 
                from substance abuse services due to the 
                existence or suspicion of mental illness.
    (d) Term of the Awards.--No entity may receive a grant, 
contract, or cooperative agreement under subsection (a) for 
more than 5 years.
    (e) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section, $50,000,000 for 
fiscal year 2001, and such sums as may be necessary for each of 
the fiscal years 2002 and 2003.

SEC. 506A. [290AA-5A] ALCOHOL AND DRUG PREVENTION OR TREATMENT SERVICES 
                    FOR INDIANS AND NATIVE ALASKANS. \1\
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    \1\ Section 3307 of Public Law 106-310 (114 Stat. 1216) establishes 
a Commission on Indian and Native Alaskan Health Care and provides that 
the Commission ``shall examine the health concerns of Indians and 
Native Alaskans who reside on reservations and tribal lands''.
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    (a) In General.--The Secretary shall award grants, 
contracts, or cooperative agreements to public and private 
nonprofit entities, including Native Alaskan entities and 
Indian tribes and tribal organizations, for the purpose of 
providing alcohol and drug prevention or treatment services for 
Indians and Native Alaskans.
    (b) Priority.--In awarding grants, contracts, or 
cooperative agreements under subsection (a), the Secretary 
shall give priority to applicants that--
            (1) propose to provide alcohol and drug prevention 
        or treatment services on reservations;
            (2) propose to employ culturally-appropriate 
        approaches, as determined by the Secretary, in 
        providing such services; and
            (3) have provided prevention or treatment services 
        to Native Alaskan entities and Indian tribes and tribal 
        organizations for at least 1 year prior to applying for 
        a grant under this section.
    (c) Duration.--The Secretary shall award grants, contracts, 
or cooperative agreements under subsection (a) for a period not 
to exceed 5 years.
    (d) Application.--An entity desiring a grant, contract, or 
cooperative agreement under subsection (a) shall submit an 
application to the Secretary at such time, in such manner, and 
accompanied by such information as the Secretary may reasonably 
require.
    (e) Evaluation.--An entity that receives a grant, contract, 
or cooperative agreement under subsection (a) shall submit, in 
the application for such grant, a plan for the evaluation of 
any project undertaken with funds provided under this section. 
Such entity shall provide the Secretary with periodic 
evaluations of the progress of such project and such evaluation 
at the completion of such project as the Secretary determines 
to be appropriate. The final evaluation submitted by such 
entity shall include a recommendation as to whether such 
project shall continue.
    (f ) Report.--Not later than 3 years after the date of the 
enactment of this section and annually thereafter, the 
Secretary shall prepare and submit, to the Committee on Health, 
Education, Labor, and Pensions of the Senate, a report 
describing the services provided pursuant to this section.
    (g) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section, $15,000,000 for 
fiscal year 2001, and such sums as may be necessary for fiscal 
years 2002 and 2003.

SEC. 506B. [290AA-5B] GRANTS FOR ECSTASY AND OTHER CLUB DRUGS ABUSE 
                    PREVENTION.

    (a) Authority.--The Administrator may make grants to, and 
enter into contracts and cooperative agreements with, public 
and nonprofit private entities to enable such entities--
            (1) to carry out school-based programs concerning 
        the dangers of the abuse of and addiction to 3,4-
        methylenedioxy methamphetamine, related drugs, and 
        other drugs commonly referred to as ``club drugs'' 
        using methods that are effective and science-based, 
        including initiatives that give students the 
        responsibility to create their own anti-drug abuse 
        education programs for their schools; and
            (2) to carry out community-based abuse and 
        addiction prevention programs relating to 3,4-
        methylenedioxy methamphetamine, related drugs, and 
        other club drugs that are effective and science-based.
    (b) Use of Funds.--Amounts made available under a grant, 
contract or cooperative agreement under subsection (a) shall be 
used for planning, establishing, or administering prevention 
programs relating to 3,4-methylenedioxy methamphetamine, 
related drugs, and other club drugs.
    (c) Use of Funds.--
            (1) Discretionary functions.--Amounts provided to 
        an entity under this section may be used--
                    (A) to carry out school-based programs that 
                are focused on those districts with high or 
                increasing rates of abuse and addiction to 3,4-
                methylenedioxy methamphetamine, related drugs, 
                and other club drugs and targeted at 
                populations that are most at risk to start 
                abusing these drugs;
                    (B) to carry out community-based prevention 
                programs that are focused on those populations 
                within the community that are most at-risk for 
                abuse of and addiction to 3,4-methylenedioxy 
                methamphetamine, related drugs, and other club 
                drugs;
                    (C) to assist local government entities to 
                conduct appropriate prevention activities 
                relating to 3,4-methylenedioxy methamphetamine, 
                related drugs, and other club drugs;
                    (D) to train and educate State and local 
                law enforcement officials, prevention and 
                education officials, health professionals, 
                members of community anti-drug coalitions and 
                parents on the signs of abuse of and addiction 
                to 3,4-methylenedioxy methamphetamine, related 
                drugs, and other club drugs and the options for 
                treatment and prevention;
                    (E) for planning, administration, and 
                educational activities related to the 
                prevention of abuse of and addiction to 3,4-
                methylenedioxy methamphetamine, related drugs, 
                and other club drugs;
                    (F) for the monitoring and evaluation of 
                prevention activities relating to 3,4-
                methylenedioxy methamphetamine, related drugs, 
                and other club drugs and reporting and 
                disseminating resulting information to the 
                public; and
                    (G) for targeted pilot programs with 
                evaluation components to encourage innovation 
                and experimentation with new methodologies.
            (2) Priority.--The Administrator shall give 
        priority in awarding grants under this section to rural 
        and urban areas that are experiencing a high rate or 
        rapid increases in abuse and addiction to 3,4-
        methylenedioxy methamphetamine, related drugs, and 
        other club drugs.
    (d) Allocation and Report.--
            (1) Prevention program allocation.--Not less than 
        $500,000 of the amount appropriated in each fiscal year 
        to carry out this section shall be made available to 
        the Administrator, acting in consultation with other 
        Federal agencies, to support and conduct periodic 
        analyses and evaluations of effective prevention 
        programs for abuse of and addiction to 3,4-
        methylenedioxy methamphetamine, related drugs, and 
        other club drugs and the development of appropriate 
        strategies for disseminating information about and 
        implementing such programs.
            (2) Report.--The Administrator shall annually 
        prepare and submit to the Committee on Health, 
        Education, Labor, and Pensions, the Committee on the 
        Judiciary, and the Committee on Appropriations of the 
        Senate, and the Committee on Commerce, the Committee on 
        the Judiciary, and the Committee on Appropriations of 
        the House of Representatives, a report containing the 
        results of the analyses and evaluations conducted under 
        paragraph (1).
    (e) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section--
            (1) $10,000,000 for fiscal year 2001; and
            (2) such sums as may be necessary for each 
        succeeding fiscal year.

                      Part B--Centers and Programs

            Subpart 1--Center for Substance Abuse Treatment

                center for substance abuse treatment \1\
    Sec. 507. [290bb] (a) Establishment.--There is established 
in the Administration a Center for Substance Abuse Treatment 
(hereafter in this section referred to as the ``Center''). The 
Center shall be headed by a Director (hereafter in this section 
referred to as the ``Director'') appointed by the Secretary 
from among individuals with extensive experience or academic 
qualifications in the treatment of substance abuse or in the 
evaluation of substance abuse treatment systems.
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    \1\ Section 4 of Public Law 108-358 (118 Stat. 1664) authorizes the 
Secretary of Health and Human Services to ``award grants to public and 
nonprofit private entities to enable such entities to carry out 
science-based education programs in elementary and secondary schools to 
highlight the harmful effects of anabolic steroids''. Subsection (d) of 
such section provides that there is authorized to be appropriated to 
carry out the section $15,000,000 for each of the fiscal years 2005 
through 2010.
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    (b) Duties.--The Director of the Center shall--
            (1) administer the substance abuse treatment block 
        grant program authorized in section 1921;
            (2) ensure that emphasis is placed on children and 
        adolescents in the development of treatment programs;
            (3) collaborate with the Attorney General to 
        develop programs to provide substance abuse treatment 
        services to individuals who have had contact with the 
        Justice system, especially adolescents;
            (4) collaborate with the Director of the Center for 
        Substance Abuse Prevention in order to provide outreach 
        services to identify individuals in need of treatment 
        services, with emphasis on the provision of such 
        services to pregnant and postpartum women and their 
        infants and to individuals who abuse drugs 
        intravenously;
            (5) collaborate with the Director of the National 
        Institute on Drug Abuse, with the Director of the 
        National Institute on Alcohol Abuse and Alcoholism, and 
        with the States to promote the study, dissemination, 
        and implementation of research findings that will 
        improve the delivery and effectiveness of treatment 
        services;
            (6) collaborate with the Administrator of the 
        Health Resources and Services Administration and the 
        Administrator of the Centers for Medicare & Medicaid 
        Services to promote the increased integration into the 
        mainstream of the health care system of the United 
        States of programs for providing treatment services;
            (7) evaluate plans submitted by the States pursuant 
        to section 1932(a)(6) in order to determine whether the 
        plans adequately provide for the availability, 
        allocation, and effectiveness of treatment services;
            (8) sponsor regional workshops on improving the 
        quality and availability of treatment services;
            (9) provide technical assistance to public and 
        nonprofit private entities that provide treatment 
        services, including technical assistance with respect 
        to the process of submitting to the Director 
        applications for any program of grants or contracts 
        carried out by the Director;
            (10) encourage the States to expand the 
        availability (relative to fiscal year 1992) of programs 
        providing treatment services through self-run, self-
        supported recovery based on the programs of housing 
        operated pursuant to section 1925;
            (11) carry out activities to educate individuals on 
        the need for establishing treatment facilities within 
        their communities;
            (12) encourage public and private entities that 
        provide health insurance to provide benefits for 
        outpatient treatment services and other nonhospital-
        based treatment services;
            (13) evaluate treatment programs to determine the 
        quality and appropriateness of various forms of 
        treatment, which shall be carried out through grants, 
        contracts, or cooperative agreements provided to public 
        or nonprofit private entities; and
            (14) in carrying out paragraph (13), assess the 
        quality, appropriateness, and costs of various 
        treatment forms for specific patient groups.
    (c) Grants and Contracts.--In carrying out the duties 
established in subsection (b), the Director may make grants to 
and enter into contracts and cooperative agreements with public 
and nonprofit private entities.
    residential treatment programs for pregnant and postpartum women
    Sec. 508. [290bb-1] (a) In General.--The Director of the 
Center for Substance Abuse Treatment shall provide awards of 
grants, cooperative agreement, or contracts to public and 
nonprofit private entities for the purpose of providing to 
pregnant and postpartum women treatment for substance abuse 
through programs in which, during the course of receiving 
treatment--
            (1) the women reside in facilities provided by the 
        programs;
            (2) the minor children of the women reside with the 
        women in such facilities, if the women so request; and
            (3) the services described in subsection (d) are 
        available to or on behalf of the women.
    (b) Availability of Services for Each Participant.--A 
funding agreement for an award under subsection (a) for an 
applicant is that, in the program operated pursuant to such 
subsection--
            (1) treatment services and each supplemental 
        service will be available through the applicant, either 
        directly or through agreements with other public or 
        nonprofit private entities; and
            (2) the services will be made available to each 
        woman admitted to the program.
    (c) Individualized Plan of Services.--A funding agreement 
for an award under subsection (a) for an applicant is that--
            (1) in providing authorized services for an 
        eligible woman pursuant to such subsection, the 
        applicant will, in consultation with the women, prepare 
        an individualized plan for the provision to the woman 
        of the services; and
            (2) treatment services under the plan will 
        include--
                    (A) individual, group, and family 
                counseling, as appropriate, regarding substance 
                abuse; and
                    (B) follow-up services to assist the woman 
                in preventing a relapse into such abuse.
    (d) Required Supplemental Services.--In the case of an 
eligible woman, the services referred to in subsection (a)(3) 
are as follows:
            (1) Prenatal and postpartum health care.
            (2) Referrals for necessary hospital services.
            (3) For the infants and children of the woman--
                    (A) pediatric health care, including 
                treatment for any perinatal effects of maternal 
                substance abuse and including screenings 
                regarding the physical and mental development 
                of the infants and children;
                    (B) counseling and other mental health 
                services, in the case of children; and
                    (C) comprehensive social services.
            (4) Providing supervision of children during 
        periods in which the woman is engaged in therapy or in 
        other necessary health or rehabilitative activities.
            (5) Training in parenting.
            (6) Counseling on the human immunodeficiency virus 
        and on acquired immune deficiency syndrome.
            (7) Counseling on domestic violence and sexual 
        abuse.
            (8) Counseling on obtaining employment, including 
        the importance of graduating from a secondary school.
            (9) Reasonable efforts to preserve and support the 
        family units of the women, including promoting the 
        appropriate involvement of parents and others, and 
        counseling the children of the women.
            (10) Planning for and counseling to assist reentry 
        into society, both before and after discharge, 
        including referrals to any public or nonprofit private 
        entities in the community involved that provide 
        services appropriate for the women and the children of 
        the women.
            (11) Case management services, including--
                    (A) assessing the extent to which 
                authorized services are appropriate for the 
                women and their children;
                    (B) in the case of the services that are 
                appropriate, ensuring that the services are 
                provided in a coordinated manner; and
                    (C) assistance in establishing eligibility 
                for assistance under Federal, State, and local 
                programs providing health services, mental 
                health services, housing services, employment 
                services, educational services, or social 
                services.
    (e) Minimum Qualifications For Receipt of Award.--
            (1) Certification by relevant state agency.--With 
        respect to the principal agency of the State involved 
        that administers programs relating to substance abuse, 
        the Director may make an award under subsection (a) to 
        an applicant only if the agency has certified to the 
        Director that--
                    (A) the applicant has the capacity to carry 
                out a program described in subsection (a);
                    (B) the plans of the applicant for such a 
                program are consistent with the policies of 
                such agency regarding the treatment of 
                substance abuse; and
                    (C) the applicant, or any entity through 
                which the applicant will provide authorized 
                services, meets all applicable State licensure 
                or certification requirements regarding the 
                provision of the services involved.
            (2) Status as medicaid provider.--
                    (A) Subject to subparagraphs (B) and (C), 
                the Director may make an award under subsection 
                (a) only if, in the case of any authorized 
                service that is available pursuant to the State 
                plan approved under title XIX of the Social 
                Security Act for the State involved--
                            (i) the applicant for the award 
                        will provide the service directly, and 
                        the applicant has entered into a 
                        participation agreement under the State 
                        plan and is qualified to receive 
                        payments under such plan; or
                            (ii) the applicant will enter into 
                        an agreement with a public or nonprofit 
                        private entity under which the entity 
                        will provide the service, and the 
                        entity has entered into such a 
                        participation agreement plan and is 
                        qualified to receive such payments.
                    (B)(i) In the case of an entity making an 
                agreement pursuant to subparagraph (A)(ii) 
                regarding the provision of services, the 
                requirement established in such subparagraph 
                regarding a participation agreement shall be 
                waived by the Director if the entity does not, 
                in providing health care services, impose a 
                charge or accept reimbursement available from 
                any third-party payor, including reimbursement 
                under any insurance policy or under any Federal 
                or State health benefits plan.
                    (ii) A determination by the Director of 
                whether an entity referred to in clause (i) 
                meets the criteria for a waiver under such 
                clause shall be made without regard to whether 
                the entity accepts voluntary donations 
                regarding the provision of services to the 
                public.
                    (C) With respect to any authorized service 
                that is available pursuant to the State plan 
                described in subparagraph (A), the requirements 
                established in such subparagraph shall not 
                apply to the provision of any such service by 
                an institution for mental diseases to an 
                individual who has attained 21 years of age and 
                who has not attained 65 years of age. For 
                purposes of the preceding sentence, the term 
                ``institution for mental diseases'' has the 
                meaning given such term in section 1905(i) of 
                the Social Security Act.
    (f) Requirement of Matching Funds.--
            (1) In general.--With respect to the costs of the 
        program to be carried out by an applicant pursuant to 
        subsection (a), a funding agreement for an award under 
        such subsection is that the applicant will make 
        available (directly or through donations from public or 
        private entities) non-Federal contributions toward such 
        costs in an amount that--
                    (A) for the first fiscal year for which the 
                applicant receives payments under an award 
                under such subsection, is not less than $1 for 
                each $9 of Federal funds provided in the award;
                    (B) for any second such fiscal year, is not 
                less than $1 for each $9 of Federal funds 
                provided in the award; and
                    (C) for any subsequent such fiscal year, is 
                not less than $1 for each $3 of Federal funds 
                provided in the award.
            (2) Determination of amount contributed.--Non-
        Federal contributions required in paragraph (1) may be 
        in cash or in kind, fairly evaluated, including plant, 
        equipment, or services. Amounts provided by the Federal 
        Government, or services assisted or subsidized to any 
        significant extent by the Federal Government, may not 
        be included in determining the amount of such non-
        Federal contributions.
    (g) Outreach.--A funding agreement for an award under 
subsection (a) for an applicant is that the applicant will 
provide outreach services in the community involved to identify 
women who are engaging in substance abuse and to encourage the 
women to undergo treatment for such abuse.
    (h) Accessibility of Program; Cultural Context of 
Services.--A funding agreement for an award under subsection 
(a) for an applicant is that--
            (1) the program operated pursuant to such 
        subsection will be operated at a location that is 
        accessible to low-income pregnant and postpartum women; 
        and
            (2) authorized services will be provided in the 
        language and the cultural context that is most 
        appropriate.
    (i) Continuing Education.--A funding agreement for an award 
under subsection (a) is that the applicant involved will 
provide for continuing education in treatment services for the 
individuals who will provide treatment in the program to be 
operated by the applicant pursuant to such subsection.
    (j) Imposition of Charges.--A funding agreement for an 
award under subsection (a) for an applicant is that, if a 
charge is imposed for the provision of authorized services to 
on \1\ behalf of an eligible woman, such charge--
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    \1\ So in law. See section 108(a) of Public Law 102-321 (106 Stat. 
336). Probably should be ``to or on''.
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            (1) will be made according to a schedule of charges 
        that is made available to the public;
            (2) will be adjusted to reflect the income of the 
        woman involved; and
            (3) will not be imposed on any such woman with an 
        income of less than 185 percent of the official poverty 
        line, as established by the Director of the Office for 
        Management and Budget and revised by the Secretary in 
        accordance with section 673(2) of the Omnibus Budget 
        Reconciliation Act of 1981.
    (k) Reports to Director.--A funding agreement for an award 
under subsection (a) is that the applicant involved will submit 
to the Director a report--
            (1) describing the utilization and costs of 
        services provided under the award;
            (2) specifying the number of women served, the 
        number of infants served, and the type and costs of 
        services provided; and
            (3) providing such other information as the 
        Director determines to be appropriate.
    (l) Requirement of Application.--The Director may make an 
award under subsection (a) only if an application for the award 
is submitted to the Director containing such agreements, and 
the application is in such form, is made in such manner, and 
contains such other agreements and such assurances and 
information as the Director determines to be necessary to carry 
out this section.
    (m) Equitable Allocation of Awards.--In making awards under 
subsection (a), the Director shall ensure that the awards are 
equitably allocated among the principal geographic regions of 
the United States, subject to the availability of qualified 
applicants for the awards.
    (n) Duration of Award.--The period during which payments 
are made to an entity from an award under subsection (a) may 
not exceed 5 years. The provision of such payments shall be 
subject to annual approval by the Director of the payments and 
subject to the availability of appropriations for the fiscal 
year involved to make the payments. This subsection may not be 
construed to establish a limitation on the number of awards 
under such subsection that may be made to an entity.
    (o) Evaluations; Dissemination of Findings.--The Director 
shall, directly or through contract, provide for the conduct of 
evaluations of programs carried out pursuant to subsection (a). 
The Director shall disseminate to the States the findings made 
as a result of the evaluations.
    (p) Reports to Congress.--Not later than October 1, 1994, 
the Director shall submit to the Committee on Energy and 
Commerce of the House of Representatives, and to the Committee 
on Labor and Human Resources of the Senate, a report describing 
programs carried out pursuant to this section. Every 2 years 
thereafter, the Director shall prepare a report describing such 
programs carried out during the preceding 2 years, and shall 
submit the report to the Administrator for inclusion in the 
biennial report under section 501(k). Each report under this 
subsection shall include a summary of any evaluations conducted 
under subsection (m) during the period with respect to which 
the report is prepared.
    (q) Definitions.--For purposes of this section:
            (1) The term ``authorized services'' means 
        treatment services and supplemental services.
            (2) The term ``eligible woman'' means a woman who 
        has been admitted to a program operated pursuant to 
        subsection (a).
            (3) The term ``funding agreement under subsection 
        (a)'', with respect to an award under subsection (a), 
        means that the Director may make the award only if the 
        applicant makes the agreement involved.
            (4) The term ``treatment services'' means treatment 
        for substance abuse, including the counseling and 
        services described in subsection (c)(2).
            (5) The term ``supplemental services'' means the 
        services described in subsection (d).
    (r) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary to \1\ fiscal years 
2001 through 2003.
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    \1\ So in law. Probably should be ``for''. See section 3301(a) of 
Public Law 106-310 (114 Stat. 1207).
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SEC. 509. [290BB-2] PRIORITY SUBSTANCE ABUSE TREATMENT NEEDS OF 
                    REGIONAL AND NATIONAL SIGNIFICANCE.

    (a) Projects.--The Secretary shall address priority 
substance abuse treatment needs of regional and national 
significance (as determined under subsection (b)) through the 
provision of or through assistance for--
            (1) knowledge development and application projects 
        for treatment and rehabilitation and the conduct or 
        support of evaluations of such projects;
            (2) training and technical assistance; and
            (3) targeted capacity response programs.
The Secretary may carry out the activities described in this 
section directly or through grants or cooperative agreements 
with States, political subdivisions of States, Indian tribes 
and tribal organizations, other public or nonprofit private 
entities.
    (b) Priority Substance Abuse Treatment Needs.--
            (1) In general.--Priority substance abuse treatment 
        needs of regional and national significance shall be 
        determined by the Secretary after consultation with 
        States and other interested groups. The Secretary shall 
        meet with the States and interested groups on an annual 
        basis to discuss program priorities.
            (2) Special consideration.--In developing program 
        priorities under paragraph (1), the Secretary shall 
        give special consideration to promoting the integration 
        of substance abuse treatment services into primary 
        health care systems.
    (c) Requirements.--
            (1) In general.--Recipients of grants, contracts, 
        or cooperative agreements under this section shall 
        comply with information and application requirements 
        determined appropriate by the Secretary.
            (2) Duration of award.--With respect to a grant, 
        contract, or cooperative agreement awarded under this 
        section, the period during which payments under such 
        award are made to the recipient may not exceed 5 years.
            (3) Matching funds.--The Secretary may, for 
        projects carried out under subsection (a), require that 
        entities that apply for grants, contracts, or 
        cooperative agreements under that project provide non-
        Federal matching funds, as determined appropriate by 
        the Secretary, to ensure the institutional commitment 
        of the entity to the projects funded under the grant, 
        contract, or cooperative agreement. Such non-Federal 
        matching funds may be provided directly or through 
        donations from public or private entities and may be in 
        cash or in kind, fairly evaluated, including plant, 
        equipment, or services.
            (4) Maintenance of effort.--With respect to 
        activities for which a grant, contract, or cooperative 
        agreement is awarded under this section, the Secretary 
        may require that recipients for specific projects under 
        subsection (a) agree to maintain expenditures of non-
        Federal amounts for such activities at a level that is 
        not less than the level of such expenditures maintained 
        by the entity for the fiscal year preceding the fiscal 
        year for which the entity receives such a grant, 
        contract, or cooperative agreement.
    (d) Evaluation.--The Secretary shall evaluate each project 
carried out under subsection (a)(1) and shall disseminate the 
findings with respect to each such evaluation to appropriate 
public and private entities.
    (e) Information and Education.--The Secretary shall 
establish comprehensive information and education programs to 
disseminate and apply the findings of the knowledge development 
and application, training and technical assistance programs, 
and targeted capacity response programs under this section to 
the general public, to health professionals and other 
interested groups. The Secretary shall make every effort to 
provide linkages between the findings of supported projects and 
State agencies responsible for carrying out substance abuse 
prevention and treatment programs.
    (f ) Authorization of Appropriation.--There are authorized 
to be appropriated to carry out this section, $300,000,000 for 
fiscal year 2001 and such sums as may be necessary for each of 
the fiscal years 2002 and 2003.

   action by national institute on drug abuse and states concerning 
                          military facilities

    Sec. 513. \1\ [290bb-6] (a) Center for Substance Abuse 
Treatment.--The Director of the Center for Substance Abuse 
Treatment shall--
---------------------------------------------------------------------------
    \1\ Sections 510 through 512 were repealed by section 3301(c) of 
Public Law 106-310 (114 Stat. 1209).
---------------------------------------------------------------------------
            (1) coordinate with the agencies represented on the 
        Commission on Alternative Utilization of Military 
        Facilities the utilization of military facilities or 
        parts thereof, as identified by such Commission, 
        established under the National Defense Authorization 
        Act of 1989, that could be utilized or renovated to 
        house nonviolent persons for drug treatment purposes;
            (2) notify State agencies responsible for the 
        oversight of drug abuse treatment entities and programs 
        of the availability of space at the installations 
        identified in paragraph (1); and
            (3) assist State agencies responsible for the 
        oversight of drug abuse treatment entities and programs 
        in developing methods for adapting the installations 
        described in paragraph (1) into residential treatment 
        centers.
    (b) States.--With regard to military facilities or parts 
thereof, as identified by the Commission on Alternative 
Utilization of Military Facilities established under section 
3042 of the Comprehensive Alcohol Abuse, Drug Abuse, and Mental 
Health Amendments Act of 1988, that could be utilized or 
renovated to house nonviolent persons for drug treatment 
purposes, State agencies responsible for the oversight of drug 
abuse treatment entities and programs shall--
            (1) establish eligibility criteria for the 
        treatment of individuals at such facilities;
            (2) select treatment providers to provide drug 
        abuse treatment at such facilities;
            (3) provide assistance to treatment providers 
        selected under paragraph (2) to assist such providers 
        in securing financing to fund the cost of the programs 
        at such facilities; and
            (4) establish, regulate, and coordinate with the 
        military official in charge of the facility, work 
        programs for individuals receiving treatment at such 
        facilities.
    (c) Reservation of Space.--Prior to notifying States of the 
availability of space at military facilities under subsection 
(a)(2), the Director may reserve space at such facilities to 
conduct research or demonstration projects.

SEC. 514. [290BB-7] SUBSTANCE ABUSE TREATMENT SERVICES FOR CHILDREN AND 
                    ADOLESCENTS.

    (a) In General.--The Secretary shall award grants, 
contracts, or cooperative agreements to public and private 
nonprofit entities, including Native Alaskan entities and 
Indian tribes and tribal organizations, for the purpose of 
providing substance abuse treatment services for children and 
adolescents.
    (b) Priority.--In awarding grants, contracts, or 
cooperative agreements under subsection (a), the Secretary 
shall give priority to applicants who propose to--
            (1) apply evidenced-based and cost effective 
        methods for the treatment of substance abuse among 
        children and adolescents;
            (2) coordinate the provision of treatment services 
        with other social service agencies in the community, 
        including educational, juvenile justice, child welfare, 
        and mental health agencies;
            (3) provide a continuum of integrated treatment 
        services, including case management, for children and 
        adolescents with substance abuse disorders and their 
        families;
            (4) provide treatment that is gender-specific and 
        culturally appropriate;
            (5) involve and work with families of children and 
        adolescents receiving treatment;
            (6) provide aftercare services for children and 
        adolescents and their families after completion of 
        substance abuse treatment; and
            (7) address the relationship between substance 
        abuse and violence.
    (c) Duration of Grants.--The Secretary shall award grants, 
contracts, or cooperative agreements under subsection (a) for 
periods not to exceed 5 fiscal years.
    (d) Application.--An entity desiring a grant, contract, or 
cooperative agreement under subsection (a) shall submit an 
application to the Secretary at such time, in such manner, and 
accompanied by such information as the Secretary may reasonably 
require.
    (e) Evaluation.--An entity that receives a grant, contract, 
or cooperative agreement under subsection (a) shall submit, in 
the application for such grant, contract, or cooperative 
agreement, a plan for the evaluation of any project undertaken 
with funds provided under this section. Such entity shall 
provide the Secretary with periodic evaluations of the progress 
of such project and such evaluation at the completion of such 
project as the Secretary determines to be appropriate.
    (f ) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section, $40,000,000 for 
fiscal year 2001, and such sums as may be necessary for fiscal 
years 2002 and 2003.

SEC. 514A. [290BB-8] EARLY INTERVENTION SERVICES FOR CHILDREN AND 
                    ADOLESCENTS.

    (a) In General.--The Secretary shall award grants, 
contracts, or cooperative agreements to public and private 
nonprofit entities, including local educational agencies (as 
defined in section 14101 of the Elementary and Secondary 
Education Act of 1965 (20 U.S.C. 8801)), for the purpose of 
providing early intervention substance abuse services for 
children and adolescents.
    (b) Priority.--In awarding grants, contracts, or 
cooperative agreements under subsection (a), the Secretary 
shall give priority to applicants who demonstrate an ability 
to--
            (1) screen for and assess substance use and abuse 
        by children and adolescents;
            (2) make appropriate referrals for children and 
        adolescents who are in need of treatment for substance 
        abuse;
            (3) provide early intervention services, including 
        counseling and ancillary services, that are designed to 
        meet the developmental needs of children and 
        adolescents who are at risk for substance abuse; and
            (4) develop networks with the educational, juvenile 
        justice, social services, and other agencies and 
        organizations in the State or local community involved 
        that will work to identify children and adolescents who 
        are in need of substance abuse treatment services.
    (c) Condition.--In awarding grants, contracts, or 
cooperative agreements under subsection (a), the Secretary 
shall ensure that such grants, contracts, or cooperative 
agreements are allocated, subject to the availability of 
qualified applicants, among the principal geographic regions of 
the United States, to Indian tribes and tribal organizations, 
and to urban and rural areas.
    (d) Duration of Grants.--The Secretary shall award grants, 
contracts, or cooperative agreements under subsection (a) for 
periods not to exceed 5 fiscal years.
    (e) Application.--An entity desiring a grant, contract, or 
cooperative agreement under subsection (a) shall submit an 
application to the Secretary at such time, in such manner, and 
accompanied by such information as the Secretary may reasonably 
require.
    (f ) Evaluation.--An entity that receives a grant, 
contract, or cooperative agreement under subsection (a) shall 
submit, in the application for such grant, contract, or 
cooperative agreement, a plan for the evaluation of any project 
undertaken with funds provided under this section. Such entity 
shall provide the Secretary with periodic evaluations of the 
progress of such project and such evaluation at the completion 
of such project as the Secretary determines to be appropriate.
    (g) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section, $20,000,000 for 
fiscal year 2001, and such sums as may be necessary for fiscal 
years 2002 and 2003.
          methamphetamine and amphetamine treatment initiative
    Sec. 514. \1\ [290bb-9] (a) Grants.--
---------------------------------------------------------------------------
    \1\ So in law. There are two sections 514. The first was added at 
the end of this subpart (subpart 1 of part B) by section 3104(a) of 
Public Law 106-310 (114 Stat. 1171). That section also added section 
514A. Section 3632 of such Public Law (114 Stat. 1236) then added at 
the end of this subpart section 514 above.
---------------------------------------------------------------------------
            (1) Authority to make grants.--The Director of the 
        Center for Substance Abuse Treatment may make grants to 
        States and Indian tribes recognized by the United 
        States that have a high rate, or have had a rapid 
        increase, in methamphetamine or amphetamine abuse or 
        addiction in order to permit such States and Indian 
        tribes to expand activities in connection with the 
        treatment of methamphetamine or amphetamine abuser or 
        addiction in the specific geographical areas of such 
        States or Indian tribes, as the case may be, where 
        there is such a rate or has been such an increase.
            (2) Recipients.--Any grants under paragraph (1) 
        shall be directed to the substance abuse directors of 
        the States, and of the appropriate tribal government 
        authorities of the Indian tribes, selected by the 
        Director to receive such grants.
            (3) Nature of activities.--Any activities under a 
        grant under paragraph (1) shall be based on reliable 
        scientific evidence of their efficacy in the treatment 
        of methamphetamine or amphetamine abuse or addiction.
    (b) Geographic Distribution.--The Director shall ensure 
that grants under subsection (a) are distributed equitably 
among the various regions of the country and among rural, 
urban, and suburban areas that are affected by methamphetamine 
or amphetamine abuse or addiction.
    (c) Additional Activities.--The Director shall--
            (1) evaluate the activities supported by grants 
        under subsection (a);
            (2) disseminate widely such significant information 
        derived from the evaluation as the Director considers 
        appropriate to assist States, Indian tribes, and 
        private providers of treatment services for 
        methamphetamine or amphetamine abuser or addiction in 
        the treatment of methamphetamine or amphetamine abuse 
        or addiction; and
            (3) provide States, Indian tribes, and such 
        providers with technical assistance in connection with 
        the provision of such treatment.
    (d) Authorization of Appropriations.--
            (1) In general.--There are authorized to be 
        appropriated to carry out this section $10,000,000 for 
        fiscal year 2000 and such sums as may be necessary for 
        each of fiscal years 2001 and 2002.
            (2) Use of certain funds.--Of the funds 
        appropriated to carry out this section in any fiscal 
        year, the lesser of 5 percent of such funds or 
        $1,000,000 shall be available to the Director for 
        purposes of carrying out subsection (c).

            Subpart 2--Center for Substance Abuse Prevention

                 office for substance abuse prevention

        Sec. 515. [290bb-21] (a) There is established in the 
Administration an Office for Substance Abuse Prevention 
(hereafter referred to in this part as the ``Prevention 
Center''). The Office \1\ shall be headed by a Director 
appointed by the Secretary from individuals with extensive 
experience or academic qualifications in the prevention of drug 
or alcohol abuse.
---------------------------------------------------------------------------
    \1\ So in law. See subsections (a), (d), and (e) of section 113 of 
Public Law 102-321 (106 Stat. 345). Probably should be ``Prevention 
Center''.
---------------------------------------------------------------------------
        (b) The Director of the Prevention Center shall--
            (1) sponsor regional workshops on the prevention of 
        drug and alcohol abuse;
            (2) coordinate the findings of research sponsored 
        by agencies of the Service on the prevention of drug 
        and alcohol abuse;
            (3) develop effective drug and alcohol abuse 
        prevention literature (including literature on the 
        adverse effects of cocaine free base (known as crack));
            (4) in cooperation with the Secretary of Education, 
        assure the widespread dissemination of prevention 
        materials among States, political subdivisions, and 
        school systems;
            (5) support clinical training programs for 
        substance abuse counselors and other health 
        professionals involved in drug abuse education, 
        prevention,; \2\
---------------------------------------------------------------------------
    \2\ So in law. See section 113(c)(1) of Public Law 102-321 (106 
Stat. 345).
---------------------------------------------------------------------------
            (6) in cooperation with the Director of the Centers 
        for Disease Control \3\, develop educational materials 
        to reduce the risks of acquired immune deficiency 
        syndrome among intravenous drug abusers;
---------------------------------------------------------------------------
    \3\ So in law. See section 113(b) of Public Law 102-321 (106 Stat. 
345). Probably should be ``Centers for Disease Control and 
Prevention''. Section 515 formerly was section 508, and after such 
redesignation, section 312(d)(10) of Public Law 102-531 (106 Stat. 
3505) attempted to amend ``section 508(b)(6)'' with respect to adding 
``and Prevention''.
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            (7) conduct training, technical assistance, data 
        collection, and evaluation activities of programs 
        supported under the Drug Free Schools and Communities 
        Act of 1986;
            (8) support the development of model, innovative, 
        community-based programs to discourage alcohol and drug 
        abuse among young people;
            (9) collaborate with the Attorney General of the 
        Department of Justice to develop programs to prevent 
        drug abuse among high risk youth;
            (10) prepare for distribution documentary films and 
        public service announcements for television and radio 
        to educate the public, especially adolescent audiences, 
        concerning the dangers to health resulting from the 
        consumption of alcohol and drugs and, to the extent 
        feasible, use appropriate private organizations and 
        business concerns in the preparation of such 
        announcements; and
            (11) develop and support innovative demonstration 
        programs designed to identify and deter the improper 
        use or abuse of anabolic steroids by students, 
        especially students in secondary schools.
    (c) The Director may make grants and enter into contracts 
and cooperative agreements in carrying out subsection (b).
    (d) The Director of the Prevention Center shall establish a 
national data base providing information on programs for the 
prevention of substance abuse. The data base shall contain 
information appropriate for use by public entities and 
information appropriate for use by nonprofit private entities.

SEC. 516. [290BB-22] PRIORITY SUBSTANCE ABUSE PREVENTION NEEDS OF 
                    REGIONAL AND NATIONAL SIGNIFICANCE.

    (a) Projects.--The Secretary shall address priority 
substance abuse prevention needs of regional and national 
significance (as determined under subsection (b)) through the 
provision of or through assistance for--
            (1) knowledge development and application projects 
        for prevention and the conduct or support of 
        evaluations of such projects;
            (2) training and technical assistance; and
            (3) targeted capacity response programs.
The Secretary may carry out the activities described in this 
section directly or through grants or cooperative agreements 
with States, political subdivisions of States, Indian tribes 
and tribal organizations, or other public or nonprofit private 
entities.
    (b) Priority Substance Abuse Prevention Needs.--
            (1) In general.--Priority substance abuse 
        prevention needs of regional and national significance 
        shall be determined by the Secretary in consultation 
        with the States and other interested groups. The 
        Secretary shall meet with the States and interested 
        groups on an annual basis to discuss program 
        priorities.
            (2) Special consideration.--In developing program 
        priorities under paragraph (1), the Secretary shall 
        give special consideration to--
                    (A) applying the most promising strategies 
                and research-based primary prevention 
                approaches; and
                    (B) promoting the integration of substance 
                abuse prevention information and activities 
                into primary health care systems.
    (c) Requirements.--
            (1) In general.--Recipients of grants, contracts, 
        and cooperative agreements under this section shall 
        comply with information and application requirements 
        determined appropriate by the Secretary.
            (2) Duration of award.--With respect to a grant, 
        contract, or cooperative agreement awarded under this 
        section, the period during which payments under such 
        award are made to the recipient may not exceed 5 years.
            (3) Matching funds.--The Secretary may, for 
        projects carried out under subsection (a), require that 
        entities that apply for grants, contracts, or 
        cooperative agreements under that project provide non-
        Federal matching funds, as determined appropriate by 
        the Secretary, to ensure the institutional commitment 
        of the entity to the projects funded under the grant, 
        contract, or cooperative agreement. Such non-Federal 
        matching funds may be provided directly or through 
        donations from public or private entities and may be in 
        cash or in kind, fairly evaluated, including plant, 
        equipment, or services.
            (4) Maintenance of effort.--With respect to 
        activities for which a grant, contract, or cooperative 
        agreement is awarded under this section, the Secretary 
        may require that recipients for specific projects under 
        subsection (a) agree to maintain expenditures of non-
        Federal amounts for such activities at a level that is 
        not less than the level of such expenditures maintained 
        by the entity for the fiscal year preceding the fiscal 
        year for which the entity receives such a grant, 
        contract, or cooperative agreement.
    (d) Evaluation.--The Secretary shall evaluate each project 
carried out under subsection (a)(1) and shall disseminate the 
findings with respect to each such evaluation to appropriate 
public and private entities.
    (e) Information and Education.--The Secretary shall 
establish comprehensive information and education programs to 
disseminate the findings of the knowledge development and 
application, training and technical assistance programs, and 
targeted capacity response programs under this section to the 
general public and to health professionals. The Secretary shall 
make every effort to provide linkages between the findings of 
supported projects and State agencies responsible for carrying 
out substance abuse prevention and treatment programs.
    (f ) Authorization of Appropriation.--There are authorized 
to be appropriated to carry out this section, $300,000,000 for 
fiscal year 2001, and such sums as may be necessary for each of 
the fiscal years 2002 and 2003.

prevention, treatment, and rehabilitation model projects for high risk 
                                 youth

      Sec. 517. [290bb-23] (a) The Secretary, through the 
Director of the Prevention Center, shall make grants to public 
and nonprofit private entities for projects to demonstrate 
effective models for the prevention, treatment, and 
rehabilitation of drug abuse and alcohol abuse among high risk 
youth.
      (b)(1) In making grants for drug abuse and alcohol abuse 
prevention projects under this section, the Secretary shall 
give priority to applications for projects directed at children 
of substance abusers, latchkey children, children at risk of 
abuse or neglect, preschool children eligible for services 
under the Head Start Act, children at risk of dropping out of 
school, children at risk of becoming adolescent parents, and 
children who do not attend school and who are at risk of being 
unemployed.
      (2) In making grants for drug abuse and alcohol abuse 
treatment and rehabilitation projects under this section, the 
Secretary shall give priority to projects which address the 
relationship between drug abuse or alcohol abuse and physical 
child abuse, sexual child abuse, emotional child abuse, 
dropping out of school, unemployment, delinquency, pregnancy, 
violence, suicide, or mental health problems.
      (3) In making grants under this section, the Secretary 
shall give priority to applications from community based 
organizations for projects to develop innovative models with 
multiple, coordinated services for the prevention or for the 
treatment and rehabilitation of drug abuse or alcohol abuse by 
high risk youth.
      (4) In making grants under this section, the Secretary 
shall give priority to applications for projects to demonstrate 
effective models with multiple, coordinated services which may 
be replicated and which are for the prevention or for the 
treatment and rehabilitation of drug abuse or alcohol abuse by 
high risk youth.
    (5) In making grants under this section, the Secretary 
shall give priority to applications that employ research 
designs adequate for evaluating the effectiveness of the 
program.
    (c) The Secretary shall ensure that projects under 
subsection (a) include strategies for reducing the use of 
alcoholic beverages and tobacco products by individuals to whom 
it is unlawful to sell or distribute such beverages or 
products.
      (d) To the extent feasible, the Secretary shall make 
grants under this section in all regions of the United States, 
and shall ensure the distribution of grants under this section 
among urban and rural areas.
      (e) In order to receive a grant for a project under this 
section for a fiscal year, a public or nonprofit private entity 
shall submit an application to the Secretary, acting through 
the Office. The Secretary may provide to the Governor of the 
State the opportunity to review and comment on such 
application. Such application shall be in such form, shall 
contain such information, and shall be submitted at such time 
as the Secretary may by regulation prescribe.
      (f) The Director \1\ of the Office shall evaluate 
projects conducted with grants under this section.
---------------------------------------------------------------------------
    \1\ So in law. See section 114, and subsections (a), (d), and (e) 
of section 113, of Public Law 102-321 (106 Stat. 346, 345). Probably 
should be ``Prevention Center''.
---------------------------------------------------------------------------
      (g) For purposes of this section, the term ``high risk 
youth'' means an individual who has not attained the age of 21 
years, who is at high risk of becoming, or who has become, a 
drug abuser or an alcohol abuser, and who--
            (1) is identified as a child of a substance abuser;
            (2) is a victim of physical, sexual, or 
        psychological abuse;
            (3) has dropped out of school;
            (4) has become pregnant;
            (5) is economically disadvantaged;
            (6) has committed a violent or delinquent act;
            (7) has experienced mental health problems;
            (8) has attempted suicide;
            (9) has experienced long-term physical pain due to 
        injury; or
            (10) has experienced chronic failure in school.
    (h) For the purpose of carrying out this section, there are 
authorized to be appropriated such sums as may be necessary for 
each of the fiscal years 2001 through 2003.

SEC. 519A. \1\ [290BB-25A] GRANTS FOR STRENGTHENING FAMILIES.
---------------------------------------------------------------------------

    \1\ The probable intent of the Congress is that section 399A of 
this Act appear before section 519A as a section 519. See footnote for 
section 399A. (Section 399A relates to grants for services for children 
of substance abusers.)
    Section 518 was repealed by section 3202(b) of Public Law 106-310 
(114 Stat. 1210).
---------------------------------------------------------------------------
    (a) Program Authorized.--The Secretary, acting through the 
Director of the Prevention Center, may make grants to public 
and nonprofit private entities to develop and implement model 
substance abuse prevention programs to provide early 
intervention and substance abuse prevention services for 
individuals of high-risk families and the communities in which 
such individuals reside.
    (b) Priority.--In awarding grants under subsection (a), the 
Secretary shall give priority to applicants that--
            (1) have proven experience in preventing substance 
        abuse by individuals of high-risk families and reducing 
        substance abuse in communities of such individuals;
            (2) have demonstrated the capacity to implement 
        community-based partnership initiatives that are 
        sensitive to the diverse backgrounds of individuals of 
        high-risk families and the communities of such 
        individuals;
            (3) have experience in providing technical 
        assistance to support substance abuse prevention 
        programs that are community-based;
            (4) have demonstrated the capacity to implement 
        research-based substance abuse prevention strategies; 
        and
            (5) have implemented programs that involve 
        families, residents, community agencies, and 
        institutions in the implementation and design of such 
        programs.
    (c) Duration of Grants.--The Secretary shall award grants 
under subsection (a) for a period not to exceed 5 years.
    (d) Use of Funds.--An applicant that is awarded a grant 
under subsection (a) shall--
            (1) in the first fiscal year that such funds are 
        received under the grant, use such funds to develop a 
        model substance abuse prevention program; and
            (2) in the fiscal year following the first fiscal 
        year that such funds are received, use such funds to 
        implement the program developed under paragraph (1) to 
        provide early intervention and substance abuse 
        prevention services to--
                    (A) strengthen the environment of children 
                of high risk families by targeting 
                interventions at the families of such children 
                and the communities in which such children 
                reside;
                    (B) strengthen protective factors, such 
                as--
                            (i) positive adult role models;
                            (ii) messages that oppose substance 
                        abuse;
                            (iii) community actions designed to 
                        reduce accessibility to and use of 
                        illegal substances; and
                            (iv) willingness of individuals of 
                        families in which substance abuse 
                        occurs to seek treatment for substance 
                        abuse;
                    (C) reduce family and community risks, such 
                as family violence, alcohol or drug abuse, 
                crime, and other behaviors that may effect 
                healthy child development and increase the 
                likelihood of substance abuse; and
                    (D) build collaborative and formal 
                partnerships between community agencies, 
                institutions, and businesses to ensure that 
                comprehensive high quality services are 
                provided, such as early childhood education, 
                health care, family support programs, parent 
                education programs, and home visits for 
                infants.
    (e) Application.--To be eligible to receive a grant under 
subsection (a), an applicant shall prepare and submit to the 
Secretary an application that--
            (1) describes a model substance abuse prevention 
        program that such applicant will establish;
            (2) describes the manner in which the services 
        described in subsection (d)(2) will be provided; and
            (3) describe in as much detail as possible the 
        results that the entity expects to achieve in 
        implementing such a program.
    (f ) Matching Funding.--The Secretary may not make a grant 
to a entity under subsection (a) unless that entity agrees 
that, with respect to the costs to be incurred by the entity in 
carrying out the program for which the grant was awarded, the 
entity will make available non-Federal contributions in an 
amount that is not less than 40 percent of the amount provided 
under the grant.
    (g) Report to Secretary.--An applicant that is awarded a 
grant under subsection (a) shall prepare and submit to the 
Secretary a report in such form and containing such information 
as the Secretary may require, including an assessment of the 
efficacy of the model substance abuse prevention program 
implemented by the applicant and the short, intermediate, and 
long term results of such program.
    (h) Evaluations.--The Secretary shall conduct evaluations, 
based in part on the reports submitted under subsection (g), to 
determine the effectiveness of the programs funded under 
subsection (a) in reducing substance use in high-risk families 
and in making communities in which such families reside in 
stronger. The Secretary shall submit such evaluations to the 
appropriate committees of Congress.
    (i) High-Risk Families.--In this section, the term ``high-
risk family'' means a family in which the individuals of such 
family are at a significant risk of using or abusing alcohol or 
any illegal substance.
    ( j) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section, $3,000,000 for 
fiscal year 2001, and such sums as may be necessary for each of 
the fiscal years 2002 and 2003.

SEC. 519B. [290BB-25B] PROGRAMS TO REDUCE UNDERAGE DRINKING.

    (a) Definitions.--For purposes of this section:
            (1) The term ``alcohol beverage industry'' means 
        the brewers, vintners, distillers, importers, 
        distributors, and retail or online outlets that sell or 
        serve beer, wine, and distilled spirits.
            (2) The term ``school-based prevention'' means 
        programs, which are institutionalized, and run by staff 
        members or school-designated persons or organizations 
        in any grade of school, kindergarten through 12th 
        grade.
            (3) The term ``youth'' means persons under the age 
        of 21.
            (4) The term ``IOM report'' means the report 
        released in September 2003 by the National Research 
        Council, Institute of Medicine, and entitled ``Reducing 
        Underage Drinking: A Collective Responsibility''.
    (b) Sense of Congress.--It is the sense of the Congress 
that:
            (1) A multi-faceted effort is needed to more 
        successfully address the problem of underage drinking 
        in the United States. A coordinated approach to 
        prevention, intervention, treatment, enforcement, and 
        research is key to making progress. This Act recognizes 
        the need for a focused national effort, and addresses 
        particulars of the Federal portion of that effort, as 
        well as Federal support for State activities.
            (2) The Secretary of Health and Human Services 
        shall continue to conduct research and collect data on 
        the short and long-range impact of alcohol use and 
        abuse upon adolescent brain development and other organ 
        systems.
            (3) States and communities, including colleges and 
        universities, are encouraged to adopt comprehensive 
        prevention approaches, including--
                    (A) evidence-based screening, programs and 
                curricula;
                    (B) brief intervention strategies;
                    (C) consistent policy enforcement; and
                    (D) environmental changes that limit 
                underage access to alcohol.
            (4) Public health groups, consumer groups, and the 
        alcohol beverage industry should continue and expand 
        evidence-based efforts to prevent and reduce underage 
        drinking.
            (5) The entertainment industries have a powerful 
        impact on youth, and they should use rating systems and 
        marketing codes to reduce the likelihood that underage 
        audiences will be exposed to movies, recordings, or 
        television programs with unsuitable alcohol content.
            (6) The National Collegiate Athletic Association, 
        its member colleges and universities, and athletic 
        conferences should affirm a commitment to a policy of 
        discouraging alcohol use among underage students and 
        other young fans.
            (7) Alcohol is a unique product and should be 
        regulated differently than other products by the States 
        and Federal Government. States have primary authority 
        to regulate alcohol distribution and sale, and the 
        Federal Government should support and supplement these 
        State efforts. States also have a responsibility to 
        fight youth access to alcohol and reduce underage 
        drinking. Continued State regulation and licensing of 
        the manufacture, importation, sale, distribution, 
        transportation and storage of alcoholic beverages are 
        clearly in the public interest and are critical to 
        promoting responsible consumption, preventing illegal 
        access to alcohol by persons under 21 years of age from 
        commercial and non-commercial sources, maintaining 
        industry integrity and an orderly marketplace, and 
        furthering effective State tax collection.
    (c) Interagency Coordinating Committee; Annual Report on 
State Underage Drinking Prevention and Enforcement 
Activities.--
            (1) Interagency coordinating committee on the 
        prevention of underage drinking.--
                    (A) In general.--The Secretary, in 
                collaboration with the Federal officials 
                specified in subparagraph (B), shall formally 
                establish and enhance the efforts of the 
                interagency coordinating committee, that began 
                operating in 2004, focusing on underage 
                drinking (referred to in this subsection as the 
                ``Committee'').
                    (B) Other agencies.--The officials referred 
                to in paragraph (1) are the Secretary of 
                Education, the Attorney General, the Secretary 
                of Transportation, the Secretary of the 
                Treasury, the Secretary of Defense, the Surgeon 
                General, the Director of the Centers for 
                Disease Control and Prevention, the Director of 
                the National Institute on Alcohol Abuse and 
                Alcoholism, the Administrator of the Substance 
                Abuse and Mental Health Services 
                Administration, the Director of the National 
                Institute on Drug Abuse, the Assistant 
                Secretary for Children and Families, the 
                Director of the Office of National Drug Control 
                Policy, the Administrator of the National 
                Highway Traffic Safety Administration, the 
                Administrator of the Office of Juvenile Justice 
                and Delinquency Prevention, the Chairman of the 
                Federal Trade Commission, and such other 
                Federal officials as the Secretary of Health 
                and Human Services determines to be 
                appropriate.
                    (C) Chair.--The Secretary of Health and 
                Human Services shall serve as the chair of the 
                Committee.
                    (D) Duties.--The Committee shall guide 
                policy and program development across the 
                Federal Government with respect to underage 
                drinking, provided, however, that nothing in 
                this section shall be construed as transferring 
                regulatory or program authority from an Agency 
                to the Coordinating Committee.
                    (E) Consultations.--The Committee shall 
                actively seek the input of and shall consult 
                with all appropriate and interested parties, 
                including States, public health research and 
                interest groups, foundations, and alcohol 
                beverage industry trade associations and 
                companies.
                    (F) Annual report.--
                            (i) In general.--The Secretary, on 
                        behalf of the Committee, shall annually 
                        submit to the Congress a report that 
                        summarizes--
                                    (I) all programs and 
                                policies of Federal agencies 
                                designed to prevent and reduce 
                                underage drinking;
                                    (II) the extent of progress 
                                in preventing and reducing 
                                underage drinking nationally;
                                    (III) data that the 
                                Secretary shall collect with 
                                respect to the information 
                                specified in clause (ii); and
                                    (IV) such other information 
                                regarding underage drinking as 
                                the Secretary determines to be 
                                appropriate.
                            (ii) Certain information.--The 
                        report under clause (i) shall include 
                        information on the following:
                                    (I) Patterns and 
                                consequences of underage 
                                drinking as reported in 
                                research and surveys such as, 
                                but not limited to Monitoring 
                                the Future, Youth Risk Behavior 
                                Surveillance System, the 
                                National Survey on Drug Use and 
                                Health, and the Fatality 
                                Analysis Reporting System.
                                    (II) Measures of the 
                                availability of alcohol from 
                                commercial and non-commercial 
                                sources to underage 
                                populations.
                                    (III) Measures of the 
                                exposure of underage 
                                populations to messages 
                                regarding alcohol in 
                                advertising and the 
                                entertainment media as reported 
                                by the Federal Trade 
                                Commission.
                                    (IV) Surveillance data, 
                                including information on the 
                                onset and prevalence of 
                                underage drinking, consumption 
                                patterns and the means of 
                                underage access. The Secretary 
                                shall develop a plan to improve 
                                the collection, measurement and 
                                consistency of reporting 
                                Federal underage alcohol data.
                                    (V) Any additional findings 
                                resulting from research 
                                conducted or supported under 
                                subsection (f).
                                    (VI) Evidence-based best 
                                practices to prevent and reduce 
                                underage drinking and provide 
                                treatment services to those 
                                youth who need them.
            (2) Annual report on state underage drinking 
        prevention and enforcement activities.--
                    (A) In general.--The Secretary shall, with 
                input and collaboration from other appropriate 
                Federal agencies, States, Indian tribes, 
                territories, and public health, consumer, and 
                alcohol beverage industry groups, annually 
                issue a report on each State's performance in 
                enacting, enforcing, and creating laws, 
                regulations, and programs to prevent or reduce 
                underage drinking.
                    (B) State performance measures.--
                            (i) In general.--The Secretary 
                        shall develop, in consultation with the 
                        Committee, a set of measures to be used 
                        in preparing the report on best 
                        practices.
                            (ii) Categories.--In developing 
                        these measures, the Secretary shall 
                        consider categories including, but not 
                        limited to:
                                    (I) Whether or not the 
                                State has comprehensive anti-
                                underage drinking laws such as 
                                for the illegal sale, purchase, 
                                attempt to purchase, 
                                consumption, or possession of 
                                alcohol; illegal use of 
                                fraudulent ID; illegal 
                                furnishing or obtaining of 
                                alcohol for an individual under 
                                21 years; the degree of 
                                strictness of the penalties for 
                                such offenses; and the 
                                prevalence of the enforcement 
                                of each of these infractions.
                                    (II) Whether or not the 
                                State has comprehensive 
                                liability statutes pertaining 
                                to underage access to alcohol 
                                such as dram shop, social host, 
                                and house party laws, and the 
                                prevalence of enforcement of 
                                each of these laws.
                                    (III) Whether or not the 
                                State encourages and conducts 
                                comprehensive enforcement 
                                efforts to prevent underage 
                                access to alcohol at retail 
                                outlets, such as random 
                                compliance checks and shoulder 
                                tap programs, and the number of 
                                compliance checks within 
                                alcohol retail outlets measured 
                                against the number of total 
                                alcohol retail outlets in each 
                                State, and the result of such 
                                checks.
                                    (IV) Whether or not the 
                                State encourages training on 
                                the proper selling and serving 
                                of alcohol for all sellers and 
                                servers of alcohol as a 
                                condition of employment.
                                    (V) Whether or not the 
                                State has policies and 
                                regulations with regard to 
                                direct sales to consumers and 
                                home delivery of alcoholic 
                                beverages.
                                    (VI) Whether or not the 
                                State has programs or laws to 
                                deter adults from purchasing 
                                alcohol for minors; and the 
                                number of adults targeted by 
                                these programs.
                                    (VII) Whether or not the 
                                State has programs targeted to 
                                youths, parents, and caregivers 
                                to deter underage drinking; and 
                                the number of individuals 
                                served by these programs.
                                    (VIII) Whether or not the 
                                State has enacted graduated 
                                drivers licenses and the extent 
                                of those provisions.
                                    (IX) The amount that the 
                                State invests, per youth 
                                capita, on the prevention of 
                                underage drinking, further 
                                broken down by the amount spent 
                                on--
                                            (aa) compliance 
                                        check programs in 
                                        retail outlets, 
                                        including providing 
                                        technology to prevent 
                                        and detect the use of 
                                        false identification by 
                                        minors to make alcohol 
                                        purchases;
                                            (bb) checkpoints 
                                        and saturation patrols 
                                        that include the goal 
                                        of reducing and 
                                        deterring underage 
                                        drinking;
                                            (cc) community-
                                        based, school-based, 
                                        and higher-education-
                                        based programs to 
                                        prevent underage 
                                        drinking;
                                            (dd) underage 
                                        drinking prevention 
                                        programs that target 
                                        youth within the 
                                        juvenile justice and 
                                        child welfare systems; 
                                        and
                                            (ee) other State 
                                        efforts or programs as 
                                        deemed appropriate.
            (3) Authorization of appropriations.--There are 
        authorized to be appropriated to carry out this 
        subsection $1,000,000 for fiscal year 2007, and 
        $1,000,000 for each of the fiscal years 2008 through 
        2010.
    (d) National Media Campaign To Prevent Underage Drinking.--
            (1) Scope of the campaign.--The Secretary shall 
        continue to fund and oversee the production, 
        broadcasting, and evaluation of the national adult-
        oriented media public service campaign if the Secretary 
        determines that such campaign is effective in achieving 
        the media campaign's measurable objectives.
            (2) Report.--The Secretary shall provide a report 
        to the Congress annually detailing the production, 
        broadcasting, and evaluation of the campaign referred 
        to in paragraph (1), and to detail in the report the 
        effectiveness of the campaign in reducing underage 
        drinking, the need for and likely effectiveness of an 
        expanded adult-oriented media campaign, and the 
        feasibility and the likely effectiveness of a national 
        youth-focused media campaign to combat underage 
        drinking.
            (3) Consultation requirement.--In carrying out the 
        media campaign, the Secretary shall direct the entity 
        carrying out the national adult-oriented media public 
        service campaign to consult with interested parties 
        including both the alcohol beverage industry and public 
        health and consumer groups. The progress of this 
        consultative process is to be covered in the report 
        under paragraph (2).
            (4) Authorization of appropriations.--There are 
        authorized to be appropriated to carry out this 
        subsection, $1,000,000 for fiscal year 2007 and 
        $1,000,000 for each of the fiscal years 2008 through 
        2010.
    (e) Interventions.--
            (1) Community-based coalition enhancement grants to 
        prevent underage drinking.--
                    (A) Authorization of program.--The 
                Administrator of the Substance Abuse and Mental 
                Health Services Administration, in consultation 
                with the Director of the Office of National 
                Drug Control Policy, shall award, if the 
                Administrator determines that the Department of 
                Health and Human Services is not currently 
                conducting activities that duplicate activities 
                of the type described in this subsection, 
                ``enhancement grants'' to eligible entities to 
                design, test, evaluate and disseminate 
                effective strategies to maximize the 
                effectiveness of community-wide approaches to 
                preventing and reducing underage drinking. This 
                subsection is subject to the availability of 
                appropriations.
                    (B) Purposes.--The purposes of this 
                paragraph are to--
                            (i) prevent and reduce alcohol use 
                        among youth in communities throughout 
                        the United States;
                            (ii) strengthen collaboration among 
                        communities, the Federal Government, 
                        and State, local, and tribal 
                        governments;
                            (iii) enhance intergovernmental 
                        cooperation and coordination on the 
                        issue of alcohol use among youth;
                            (iv) serve as a catalyst for 
                        increased citizen participation and 
                        greater collaboration among all sectors 
                        and organizations of a community that 
                        first demonstrates a long-term 
                        commitment to reducing alcohol use 
                        among youth;
                            (v) disseminate to communities 
                        timely information regarding state-of-
                        the-art practices and initiatives that 
                        have proven to be effective in 
                        preventing and reducing alcohol use 
                        among youth; and
                            (vi) enhance, not supplant, 
                        effective local community initiatives 
                        for preventing and reducing alcohol use 
                        among youth.
                    (C) Application.--An eligible entity 
                desiring an enhancement grant under this 
                paragraph shall submit an application to the 
                Administrator at such time, and in such manner, 
                and accompanied by such information as the 
                Administrator may require. Each application 
                shall include--
                            (i) a complete description of the 
                        entity's current underage alcohol use 
                        prevention initiatives and how the 
                        grant will appropriately enhance the 
                        focus on underage drinking issues; or
                            (ii) a complete description of the 
                        entity's current initiatives, and how 
                        it will use this grant to enhance those 
                        initiatives by adding a focus on 
                        underage drinking prevention.
                    (D) Uses of funds.--Each eligible entity 
                that receives a grant under this paragraph 
                shall use the grant funds to carry out the 
                activities described in such entity's 
                application submitted pursuant to subparagraph 
                (C). Grants under this paragraph shall not 
                exceed $50,000 per year and may not exceed four 
                years.
                    (E) Supplement not supplant.--Grant funds 
                provided under this paragraph shall be used to 
                supplement, not supplant, Federal and non-
                Federal funds available for carrying out the 
                activities described in this paragraph.
                    (F) Evaluation.--Grants under this 
                paragraph shall be subject to the same 
                evaluation requirements and procedures as the 
                evaluation requirements and procedures imposed 
                on recipients of drug free community grants.
                    (G) Definitions.--For purposes of this 
                paragraph, the term ``eligible entity'' means 
                an organization that is currently receiving or 
                has received grant funds under the Drug-Free 
                Communities Act of 1997 (21 U.S.C. 1521 et 
                seq.).
                    (H) Administrative expenses.--Not more than 
                6 percent of a grant under this paragraph may 
                be expended for administrative expenses.
                    (I) Authorization of appropriations.--There 
                are authorized to be appropriated to carry out 
                this paragraph $5,000,000 for fiscal year 2007, 
                and $5,000,000 for each of the fiscal years 
                2008 through 2010.
            (2) Grants directed at preventing and reducing 
        alcohol abuse at institutions of higher education.--
                    (A) Authorization of program.--The 
                Secretary shall award grants to eligible 
                entities to enable the entities to prevent and 
                reduce the rate of underage alcohol consumption 
                including binge drinking among students at 
                institutions of higher education.
                    (B) Applications.--An eligible entity that 
                desires to receive a grant under this paragraph 
                shall submit an application to the Secretary at 
                such time, in such manner, and accompanied by 
                such information as the Secretary may require. 
                Each application shall include--
                            (i) a description of how the 
                        eligible entity will work to enhance an 
                        existing, or where none exists to build 
                        a, statewide coalition;
                            (ii) a description of how the 
                        eligible entity will target underage 
                        students in the State;
                            (iii) a description of how the 
                        eligible entity intends to ensure that 
                        the statewide coalition is actually 
                        implementing the purpose of this 
                        section and moving toward indicators 
                        described in subparagraph (D);
                            (iv) a list of the members of the 
                        statewide coalition or interested 
                        parties involved in the work of the 
                        eligible entity;
                            (v) a description of how the 
                        eligible entity intends to work with 
                        State agencies on substance abuse 
                        prevention and education;
                            (vi) the anticipated impact of 
                        funds provided under this paragraph in 
                        preventing and reducing the rates of 
                        underage alcohol use;
                            (vii) outreach strategies, 
                        including ways in which the eligible 
                        entity proposes to--
                                    (I) reach out to students 
                                and community stakeholders;
                                    (II) promote the purpose of 
                                this paragraph;
                                    (III) address the range of 
                                needs of the students and the 
                                surrounding communities; and
                                    (IV) address community 
                                norms for underage students 
                                regarding alcohol use; and
                            (viii) such additional information 
                        as required by the Secretary.
                    (C) Uses of funds.--Each eligible entity 
                that receives a grant under this paragraph 
                shall use the grant funds to carry out the 
                activities described in such entity's 
                application submitted pursuant to subparagraph 
                (B).
                    (D) Accountability.--On the date on which 
                the Secretary first publishes a notice in the 
                Federal Register soliciting applications for 
                grants under this paragraph, the Secretary 
                shall include in the notice achievement 
                indicators for the program authorized under 
                this paragraph. The achievement indicators 
                shall be designed--
                            (i) to measure the impact that the 
                        statewide coalitions assisted under 
                        this paragraph are having on the 
                        institutions of higher education and 
                        the surrounding communities, including 
                        changes in the number of incidents of 
                        any kind in which students have abused 
                        alcohol or consumed alcohol while under 
                        the age of 21 (including violations, 
                        physical assaults, sexual assaults, 
                        reports of intimidation, disruptions of 
                        school functions, disruptions of 
                        student studies, mental health 
                        referrals, illnesses, or deaths);
                            (ii) to measure the quality and 
                        accessibility of the programs or 
                        information offered by the eligible 
                        entity; and
                            (iii) to provide such other 
                        measures of program impact as the 
                        Secretary determines appropriate.
                    (E) Supplement not supplant.--Grant funds 
                provided under this paragraph shall be used to 
                supplement, and not supplant, Federal and non-
                Federal funds available for carrying out the 
                activities described in this paragraph.
                    (F) Definitions.--For purposes of this 
                paragraph:
                            (i) Eligible entity.--The term 
                        ``eligible entity'' means a State, 
                        institution of higher education, or 
                        nonprofit entity.
                            (ii) Institution of higher 
                        education.--The term ``institution of 
                        higher education'' has the meaning 
                        given the term in section 101(a) of the 
                        Higher Education Act of 1965 (20 U.S.C. 
                        1001(a)).
                            (iii) Secretary.--The term 
                        ``Secretary'' means the Secretary of 
                        Education.
                            (iv) State.--The term ``State'' 
                        means each of the 50 States, the 
                        District of Columbia, and the 
                        Commonwealth of Puerto Rico.
                            (v) Statewide coalition.--The term 
                        ``statewide coalition'' means a 
                        coalition that--
                                    (I) includes, but is not 
                                limited to--
                                            (aa) institutions 
                                        of higher education 
                                        within a State; and
                                            (bb) a nonprofit 
                                        group, a community 
                                        underage drinking 
                                        prevention coalition, 
                                        or another substance 
                                        abuse prevention group 
                                        within a State; and
                                    (II) works toward lowering 
                                the alcohol abuse rate by 
                                targeting underage students at 
                                institutions of higher 
                                education throughout the State 
                                and in the surrounding 
                                communities.
                            (vi) Surrounding community.--The 
                        term ``surrounding community'' means 
                        the community--
                                    (I) that surrounds an 
                                institution of higher education 
                                participating in a statewide 
                                coalition;
                                    (II) where the students 
                                from the institution of higher 
                                education take part in the 
                                community; and
                                    (III) where students from 
                                the institution of higher 
                                education live in off-campus 
                                housing.
                    (G) Administrative expenses.--Not more than 
                5 percent of a grant under this paragraph may 
                be expended for administrative expenses.
                    (H) Authorization of appropriations.--There 
                are authorized to be appropriated to carry out 
                this paragraph $5,000,000 for fiscal year 2007, 
                and $5,000,000 for each of the fiscal years 
                2008 through 2010.
    (f) Additional Research.--
            (1) Additional research on underage drinking.--
                    (A) In general.--The Secretary shall, 
                subject to the availability of appropriations, 
                collect data, and conduct or support research 
                that is not duplicative of research currently 
                being conducted or supported by the Department 
                of Health and Human Services, on underage 
                drinking, with respect to the following:
                            (i) Comprehensive community-based 
                        programs or strategies and statewide 
                        systems to prevent and reduce underage 
                        drinking, across the underage years 
                        from early childhood to age 21, 
                        including programs funded and 
                        implemented by government entities, 
                        public health interest groups and 
                        foundations, and alcohol beverage 
                        companies and trade associations.
                            (ii) Annually obtain and report 
                        more precise information than is 
                        currently collected on the scope of the 
                        underage drinking problem and patterns 
                        of underage alcohol consumption, 
                        including improved knowledge about the 
                        problem and progress in preventing, 
                        reducing and treating underage 
                        drinking; as well as information on the 
                        rate of exposure of youth to 
                        advertising and other media messages 
                        encouraging and discouraging alcohol 
                        consumption.
                            (iii) Compiling information on the 
                        involvement of alcohol in unnatural 
                        deaths of persons ages 12 to 20 in the 
                        United States, including suicides, 
                        homicides, and unintentional injuries 
                        such as falls, drownings, burns, 
                        poisonings, and motor vehicle crash 
                        deaths.
                    (B) Certain matters.--The Secretary shall 
                carry out activities toward the following 
                objectives with respect to underage drinking:
                            (i) Obtaining new epidemiological 
                        data within the national or targeted 
                        surveys that identify alcohol use and 
                        attitudes about alcohol use during pre- 
                        and early adolescence, including harm 
                        caused to self or others as a result of 
                        adolescent alcohol use such as 
                        violence, date rape, risky sexual 
                        behavior, and prenatal alcohol 
                        exposure.
                            (ii) Developing or identifying 
                        successful clinical treatments for 
                        youth with alcohol problems.
                    (C) Peer review.--Research under 
                subparagraph (A) shall meet current Federal 
                standards for scientific peer review.
            (2) Authorization of appropriations.--There are 
        authorized to be appropriated to carry out this 
        subsection $6,000,000 for fiscal year 2007, and 
        $6,000,000 for each of the fiscal years 2008 through 
        2010.

SEC. 519C. [290BB-25C] SERVICES FOR INDIVIDUALS WITH FETAL ALCOHOL 
                    SYNDROME.

    (a) In General.--The Secretary shall make awards of grants, 
cooperative agreements, or contracts to public and nonprofit 
private entities, including Indian tribes and tribal 
organizations, to provide services to individuals diagnosed 
with fetal alcohol syndrome or alcohol-related birth defects.
    (b) Use of Funds.--An award under subsection (a) may, 
subject to subsection (d), be used to--
            (1) screen and test individuals to determine the 
        type and level of services needed;
            (2) develop a comprehensive plan for providing 
        services to the individual;
            (3) provide mental health counseling;
            (4) provide substance abuse prevention services and 
        treatment, if needed;
            (5) coordinate services with other social programs 
        including social services, justice system, educational 
        services, health services, mental health and substance 
        abuse services, financial assistance programs, 
        vocational services and housing assistance programs;
            (6) provide vocational services;
            (7) provide health counseling;
            (8) provide housing assistance;
            (9) parenting skills training;
            (10) overall case management;
            (11) supportive services for families of 
        individuals with Fetal Alcohol Syndrome; and
            (12) provide other services and programs, to the 
        extent authorized by the Secretary after consideration 
        of recommendations made by the National Task Force on 
        Fetal Alcohol Syndrome.
    (c) Requirements.--To be eligible to receive an award under 
subsection (a), an applicant shall--
            (1) demonstrate that the program will be part of a 
        coordinated, comprehensive system of care for such 
        individuals;
            (2) demonstrate an established communication with 
        other social programs in the community including social 
        services, justice system, financial assistance 
        programs, health services, educational services, mental 
        health and substance abuse services, vocational 
        services and housing assistance services;
            (3) show a history of working with individuals with 
        fetal alcohol syndrome or alcohol-related birth 
        defects;
            (4) provide assurance that the services will be 
        provided in a culturally and linguistically appropriate 
        manner; and
            (5) provide assurance that at the end of the 5-year 
        award period, other mechanisms will be identified to 
        meet the needs of the individuals and families served 
        under such award.
    (d) Relationship to Payments Under Other Programs.--An 
award may be made under subsection (a) only if the applicant 
involved agrees that the award will not be expended to pay the 
expenses of providing any service under this section to an 
individual to the extent that payment has been made, or can 
reasonably be expected to be made, with respect to such 
expenses--
            (1) under any State compensation program, under an 
        insurance policy, or under any Federal or State health 
        benefits program; or
            (2) by an entity that provides health services on a 
        prepaid basis.
    (e) Duration of Awards.--With respect to an award under 
subsection (a), the period during which payments under such 
award are made to the recipient may not exceed 5 years.
    (f ) Evaluation.--The Secretary shall evaluate each project 
carried out under subsection (a) and shall disseminate the 
findings with respect to each such evaluation to appropriate 
public and private entities.
    (g) Funding.--
            (1) Authorization of appropriations.--For the 
        purpose of carrying out this section, there are 
        authorized to be appropriated $25,000,000 for fiscal 
        year 2001, and such sums as may be necessary for each 
        of the fiscal years 2002 and 2003.
            (2) Allocation.--Of the amounts appropriated under 
        paragraph (1) for a fiscal year, not less than $300,000 
        shall, for purposes relating to fetal alcohol syndrome 
        and alcohol-related birth defects, be made available 
        for collaborative, coordinated interagency efforts with 
        the National Institute on Alcohol Abuse and Alcoholism, 
        the Eunice Kennedy Shriver National Institute of Child 
        Health and Human Development, the Health Resources and 
        Services Administration, the Agency for Healthcare 
        Research and Quality, the Centers for Disease Control 
        and Prevention, the Department of Education, and the 
        Department of Justice.

SEC. 519D. [290BB-25D] CENTERS OF EXCELLENCE ON SERVICES FOR 
                    INDIVIDUALS WITH FETAL ALCOHOL SYNDROME AND 
                    ALCOHOL-RELATED BIRTH DEFECTS AND TREATMENT FOR 
                    INDIVIDUALS WITH SUCH CONDITIONS AND THEIR 
                    FAMILIES.

    (a) In General.--The Secretary shall make awards of grants, 
cooperative agreements, or contracts to public or nonprofit 
private entities for the purposes of establishing not more than 
four centers of excellence to study techniques for the 
prevention of fetal alcohol syndrome and alcohol-related birth 
defects and adaptations of innovative clinical interventions 
and service delivery improvements for the provision of 
comprehensive services to individuals with fetal alcohol 
syndrome or alcohol-related birth defects and their families 
and for providing training on such conditions.
    (b) Use of Funds.--An award under subsection (a) may be 
used to--
            (1) study adaptations of innovative clinical 
        interventions and service delivery improvements 
        strategies for children and adults with fetal alcohol 
        syndrome or alcohol-related birth defects and their 
        families;
            (2) identify communities which have an exemplary 
        comprehensive system of care for such individuals so 
        that they can provide technical assistance to other 
        communities attempting to set up such a system of care;
            (3) provide technical assistance to communities who 
        do not have a comprehensive system of care for such 
        individuals and their families;
            (4) train community leaders, mental health and 
        substance abuse professionals, families, law 
        enforcement personnel, judges, health professionals, 
        persons working in financial assistance programs, 
        social service personnel, child welfare professionals, 
        and other service providers on the implications of 
        fetal alcohol syndrome and alcohol-related birth 
        defects, the early identification of and referral for 
        such conditions;
            (5) develop innovative techniques for preventing 
        alcohol use by women in child bearing years; \1\
---------------------------------------------------------------------------
    \1\So in law. Probably should read ``; and''. See section 3110 of 
Public Law 106-310 (114 Stat. 1185).
---------------------------------------------------------------------------
            (6) perform other functions, to the extent 
        authorized by the Secretary after consideration of 
        recommendations made by the National Task Force on 
        Fetal Alcohol Syndrome.
    (c) Report.--
            (1) In general.--A recipient of an award under 
        subsection (a) shall at the end of the period of 
        funding report to the Secretary on any innovative 
        techniques that have been discovered for preventing 
        alcohol use among women of child bearing years.
            (2) Dissemination of findings.--The Secretary shall 
        upon receiving a report under paragraph (1) disseminate 
        the findings to appropriate public and private 
        entities.
    (d) Duration of Awards.--With respect to an award under 
subsection (a), the period during which payments under such 
award are made to the recipient may not exceed 5 years.
    (e) Evaluation.--The Secretary shall evaluate each project 
carried out under subsection (a) and shall disseminate the 
findings with respect to each such evaluation to appropriate 
public and private entities.
    (f ) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated $5,000,000 for fiscal year 2001, and such sums as 
may be necessary for each of the fiscal years 2002 and 2003.

SEC. 519E. \1\ [290BB-25E] PREVENTION OF METHAMPHETAMINE AND INHALANT 
                    ABUSE AND ADDICTION.
---------------------------------------------------------------------------

    \1\ The placement of section 519E is according to the probable 
intent of the Congress. Section 3104(c) of Public Law 106-310 (114 
Stat. 1173) added the section to this subpart, but did not specify the 
specific placement of the section.
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    (a) Grants.--The Director of the Center for Substance Abuse 
Prevention (referred to in this section as the ``Director'') 
may make grants to and enter into contracts and cooperative 
agreements with public and nonprofit private entities to enable 
such entities--
            (1) to carry out school-based programs concerning 
        the dangers of methamphetamine or inhalant abuse and 
        addiction, using methods that are effective and 
        evidence-based, including initiatives that give 
        students the responsibility to create their own anti-
        drug abuse education programs for their schools; and
            (2) to carry out community-based methamphetamine or 
        inhalant abuse and addiction prevention programs that 
        are effective and evidence-based.
    (b) Use of Funds.--Amounts made available under a grant, 
contract or cooperative agreement under subsection (a) shall be 
used for planning, establishing, or administering 
methamphetamine or inhalant prevention programs in accordance 
with subsection (c).
    (c) Prevention Programs and Activities.--
            (1) In general.--Amounts provided under this 
        section may be used--
                    (A) to carry out school-based programs that 
                are focused on those districts with high or 
                increasing rates of methamphetamine or inhalant 
                abuse and addiction and targeted at populations 
                which are most at risk to start methamphetamine 
                or inhalant abuse;
                    (B) to carry out community-based prevention 
                programs that are focused on those populations 
                within the community that are most at-risk for 
                methamphetamine or inhalant abuse and 
                addiction;
                    (C) to assist local government entities to 
                conduct appropriate methamphetamine or inhalant 
                prevention activities;
                    (D) to train and educate State and local 
                law enforcement officials, prevention and 
                education officials, members of community anti-
                drug coalitions and parents on the signs of 
                methamphetamine or inhalant abuse and addiction 
                and the options for treatment and prevention;
                    (E) for planning, administration, and 
                educational activities related to the 
                prevention of methamphetamine or inhalant abuse 
                and addiction;
                    (F) for the monitoring and evaluation of 
                methamphetamine or inhalant prevention 
                activities, and reporting and disseminating 
                resulting information to the public; and
                    (G) for targeted pilot programs with 
                evaluation components to encourage innovation 
                and experimentation with new methodologies.
            (2) Priority.--The Director shall give priority in 
        making grants under this section to rural and urban 
        areas that are experiencing a high rate or rapid 
        increases in methamphetamine or inhalant abuse and 
        addiction.
    (d) Analyses and Evaluation.--
            (1) In general.--Up to $500,000 of the amount 
        available in each fiscal year to carry out this section 
        shall be made available to the Director, acting in 
        consultation with other Federal agencies, to support 
        and conduct periodic analyses and evaluations of 
        effective prevention programs for methamphetamine or 
        inhalant abuse and addiction and the development of 
        appropriate strategies for disseminating information 
        about and implementing these programs.
            (2) Annual reports.--The Director shall submit to 
        the Committee on Health, Education, Labor, and Pensions 
        and the Committee on Appropriations of the Senate and 
        the Committee on Commerce and Committee on 
        Appropriations of the House of Representatives, an 
        annual report with the results of the analyses and 
        evaluation under paragraph (1).
    (e) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out subsection (a), $10,000,000 for 
fiscal year 2001, and such sums as may be necessary for each of 
fiscal years 2002 and 2003.

              Subpart 3--Center for Mental Health Services

                   center for mental health services
    Sec. 520. [290bb-31] (a) Establishment.--There is 
established in the Administration a Center for Mental Health 
Services (hereafter in this section referred to as the 
``Center''). The Center shall be headed by a Director 
(hereafter in this section referred to as the ``Director'') 
appointed by the Secretary from among individuals with 
extensive experience or academic qualifications in the 
provision of mental health services or in the evaluation of 
mental health service systems.
    (b) Duties.--The Director of the Center shall--
            (1) design national goals and establish national 
        priorities for--
                    (A) the prevention of mental illness; and
                    (B) the promotion of mental health;
            (2) encourage and assist local entities and State 
        agencies to achieve the goals and priorities described 
        in paragraph (1);
            (3) collaborate with the Department of Education 
        and the Department of Justice to develop programs to 
        assist local communities in addressing violence among 
        children and adolescents;
            (4) develop and coordinate Federal prevention 
        policies and programs and to assure increased focus on 
        the prevention of mental illness and the promotion of 
        mental health;
            (5) develop improved methods of treating 
        individuals with mental health problems and improved 
        methods of assisting the families of such individuals;
            (6) administer the mental health services block 
        grant program authorized in section 1911;
            (7) promote policies and programs at Federal, 
        State, and local levels and in the private sector that 
        foster independence and protect the legal rights of 
        persons with mental illness, including carrying out the 
        provisions of the Protection and Advocacy of Mentally 
        Ill Individuals Act;
            (8) carry out the programs under part C;
            (9) carry out responsibilities for the Human 
        Resource Development program, and programs of clinical 
        training for professional and paraprofessional 
        personnel pursuant to section 303 \1\;
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    \1\ The probable intent of the Congress is that the paragraph read 
``(9) carry out responsibilities for the Human Resource Development 
Program;''. See section 3112(c)(4) of Public Law 106-310 (114 Stat. 
1188), which provides that paragraph (9) is amended ``by striking 
`program and programs' and all that follows through `303' and inserting 
`programs' ''. The amendment cannot be executed because the term to be 
struck does not appear in paragraph (9). (Compare ``program and 
programs'' and ``program, and programs''.)
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            (10) conduct services-related assessments, 
        including evaluations of the organization and financing 
        of care, self-help and consumer-run programs, mental 
        health economics, mental health service systems, rural 
        mental health, and improve the capacity of State to 
        conduct evaluations of publicly funded mental health 
        programs;
            (11) establish a clearinghouse for mental health 
        information to assure the widespread dissemination of 
        such information to States, political subdivisions, 
        educational agencies and institutions, treatment and 
        prevention service providers, and the general public, 
        including information concerning the practical 
        application of research supported by the National 
        Institute of Mental Health that is applicable to 
        improving the delivery of services;
            (12) provide technical assistance to public and 
        private entities that are providers of mental health 
        services;
            (13) monitor and enforce obligations incurred by 
        community mental health centers pursuant to the 
        Community Mental Health Centers Act (as in effect prior 
        to the repeal of such Act on August 13, 1981, by 
        section 902(e)(2)(B) of Public Law 97-35 (95 Stat. 
        560));
            (14) conduct surveys with respect to mental health, 
        such as the National Reporting Program; and
            (15) assist States in improving their mental health 
        data collection.
    (c) Grants and Contracts.--In carrying out the duties 
established in subsection (b), the Director may make grants to 
and enter into contracts and cooperative agreements with public 
and nonprofit private entities.

SEC. 520A. [290BB-32] PRIORITY MENTAL HEALTH NEEDS OF REGIONAL AND 
                    NATIONAL SIGNIFICANCE.

    (a) Projects.--The Secretary shall address priority mental 
health needs of regional and national significance (as 
determined under subsection (b)) through the provision of or 
through assistance for--
            (1) knowledge development and application projects 
        for prevention, treatment, and rehabilitation, and the 
        conduct or support of evaluations of such projects;
            (2) training and technical assistance programs;
            (3) targeted capacity response programs; and
            (4) systems change grants including statewide 
        family network grants and client-oriented and consumer 
        run self-help activities.
The Secretary may carry out the activities described in this 
subsection directly or through grants or cooperative agreements 
with States, political subdivisions of States, Indian tribes 
and tribal organizations, other public or private nonprofit 
entities.
    (b) Priority Mental Health Needs.--
            (1) Determination of needs.--Priority mental health 
        needs of regional and national significance shall be 
        determined by the Secretary in consultation with States 
        and other interested groups. The Secretary shall meet 
        with the States and interested groups on an annual 
        basis to discuss program priorities.
            (2) Special consideration.--In developing program 
        priorities described in paragraph (1), the Secretary 
        shall give special consideration to promoting the 
        integration of mental health services into primary 
        health care systems.
    (c) Requirements.--
            (1) In general.--Recipients of grants, contracts, 
        and cooperative agreements under this section shall 
        comply with information and application requirements 
        determined appropriate by the Secretary.
            (2) Duration of award.--With respect to a grant, 
        contract, or cooperative agreement awarded under this 
        section, the period during which payments under such 
        award are made to the recipient may not exceed 5 years.
            (3) Matching funds.--The Secretary may, for 
        projects carried out under subsection (a), require that 
        entities that apply for grants, contracts, or 
        cooperative agreements under this section provide non-
        Federal matching funds, as determined appropriate by 
        the Secretary, to ensure the institutional commitment 
        of the entity to the projects funded under the grant, 
        contract, or cooperative agreement. Such non-Federal 
        matching funds may be provided directly or through 
        donations from public or private entities and may be in 
        cash or in kind, fairly evaluated, including plant, 
        equipment, or services.
            (4) Maintenance of effort.--With respect to 
        activities for which a grant, contract or cooperative 
        agreement is awarded under this section, the Secretary 
        may require that recipients for specific projects under 
        subsection (a) agree to maintain expenditures of non-
        Federal amounts for such activities at a level that is 
        not less than the level of such expenditures maintained 
        by the entity for the fiscal year preceding the fiscal 
        year for which the entity receives such a grant, 
        contract, or cooperative agreement.
    (d) Evaluation.--The Secretary shall evaluate each project 
carried out under subsection (a)(1) and shall disseminate the 
findings with respect to each such evaluation to appropriate 
public and private entities.
    (e) Information and Education.--
            (1) In general.--The Secretary shall establish 
        information and education programs to disseminate and 
        apply the findings of the knowledge development and 
        application, training, and technical assistance 
        programs, and targeted capacity response programs, 
        under this section to the general public, to health 
        care professionals, and to interested groups. The 
        Secretary shall make every effort to provide linkages 
        between the findings of supported projects and State 
        agencies responsible for carrying out mental health 
        services.
            (2) Rural and underserved areas.--In disseminating 
        information on evidence-based practices in the 
        provision of children's mental health services under 
        this subsection, the Secretary shall ensure that such 
        information is distributed to rural and medically 
        underserved areas.
    (f ) Authorization of Appropriation.--
            (1) In general.--There are authorized to be 
        appropriated to carry out this section, $300,000,000 
        for fiscal year 2001, and such sums as may be necessary 
        for each of the fiscal years 2002 and 2003.
            (2) Data infrastructure.--If amounts are not 
        appropriated for a fiscal year to carry out section 
        1971 with respect to mental health, then the Secretary 
        shall make available, from the amounts appropriated for 
        such fiscal year under paragraph (1), an amount equal 
        to the sum of $6,000,000 and 10 percent of all amounts 
        appropriated for such fiscal year under such paragraph 
        in excess of $100,000,000, to carry out such section 
        1971.

SEC. 520B. [290BB-33] NATIONAL CENTERS OF EXCELLENCE FOR DEPRESSION.

    (a) Depressive Disorder Defined.--In this section, the term 
``depressive disorder'' means a mental or brain disorder 
relating to depression, including major depression, bipolar 
disorder, and related mood disorders.
    (b) Grant Program.--
            (1) In general.--The Secretary, acting through the 
        Administrator, shall award grants on a competitive 
        basis to eligible entities to establish national 
        centers of excellence for depression (referred to in 
        this section as ``Centers''), which shall engage in 
        activities related to the treatment of depressive 
        disorders.
            (2) Allocation of awards.--If the funds authorized 
        under subsection (f) are appropriated in the amounts 
        provided for under such subsection, the Secretary shall 
        allocate such amounts so that--
                    (A) not later than 1 year after the date of 
                enactment of the ENHANCED Act of 2009, not more 
                than 20 Centers may be established; and
                    (B) not later than September 30, 2016, not 
                more than 30 Centers may be established.
            (3) Grant period.--
                    (A) In general.--A grant awarded under this 
                section shall be for a period of 5 years.
                    (B) Renewal.--A grant awarded under 
                subparagraph (A) may be renewed, on a 
                competitive basis, for 1 additional 5-year 
                period, at the discretion of the Secretary. In 
                determining whether to renew a grant, the 
                Secretary shall consider the report cards 
                issued under subsection (e)(2).
            (4) Use of funds.--Grant funds awarded under this 
        subsection shall be used for the establishment and 
        ongoing activities of the recipient of such funds.
            (5) Eligible entities.--
                    (A) Requirements.--To be eligible to 
                receive a grant under this section, an entity 
                shall--
                            (i) be an institution of higher 
                        education or a public or private 
                        nonprofit research institution; and
                            (ii) submit an application to the 
                        Secretary at such time and in such 
                        manner as the Secretary may require, as 
                        described in subparagraph (B).
                    (B) Application.--An application described 
                in subparagraph (A)(ii) shall include--
                            (i) evidence that such entity--
                                    (I) provides, or is capable 
                                of coordinating with other 
                                entities to provide, 
                                comprehensive health services 
                                with a focus on mental health 
                                services and subspecialty 
                                expertise for depressive 
                                disorders;
                                    (II) collaborates with 
                                other mental health providers, 
                                as necessary, to address co-
                                occurring mental illnesses;
                                    (III) is capable of 
                                training health professionals 
                                about mental health; and
                            (ii) such other information, as the 
                        Secretary may require.
                    (C) Priorities.--In awarding grants under 
                this section, the Secretary shall give priority 
                to eligible entities that meet 1 or more of the 
                following criteria:
                            (i) Demonstrated capacity and 
                        expertise to serve the targeted 
                        population.
                            (ii) Existing infrastructure or 
                        expertise to provide appropriate, 
                        evidence-based and culturally and 
                        linguistically competent services.
                            (iii) A location in a geographic 
                        area with disproportionate numbers of 
                        underserved and at-risk populations in 
                        medically underserved areas and health 
                        professional shortage areas.
                            (iv) Proposed innovative approaches 
                        for outreach to initiate or expand 
                        services.
                            (v) Use of the most up-to-date 
                        science, practices, and interventions 
                        available.
                            (vi) Demonstrated capacity to 
                        establish cooperative and collaborative 
                        agreements with community mental health 
                        centers and other community entities to 
                        provide mental health, social, and 
                        human services to individuals with 
                        depressive disorders.
            (6) National coordinating center.--
                    (A) In general.--The Secretary, acting 
                through the Administrator, shall designate 1 
                recipient of a grant under this section to be 
                the coordinating center of excellence for 
                depression (referred to in this section as the 
                ``coordinating center''). The Secretary shall 
                select such coordinating center on a 
                competitive basis, based upon the demonstrated 
                capacity of such center to perform the duties 
                described in subparagraph (C).
                    (B) Application.--A Center that has been 
                awarded a grant under paragraph (1) may apply 
                for designation as the coordinating center by 
                submitting an application to the Secretary at 
                such time, in such manner, and containing such 
                information as the Secretary may require.
                    (C) Duties.--The coordinating center 
                shall--
                            (i) develop, administer, and 
                        coordinate the network of Centers under 
                        this section;
                            (ii) oversee and coordinate the 
                        national database described in 
                        subsection (d);
                            (iii) lead a strategy to 
                        disseminate the findings and activities 
                        of the Centers through such database; 
                        and
                            (iv) serve as a liaison with the 
                        Administration, the National Registry 
                        of Evidence-based Programs and 
                        Practices of the Administration, and 
                        any Federal interagency or interagency 
                        forum on mental health.
            (7) Matching funds.--The Secretary may not award a 
        grant or contract under this section to an entity 
        unless the entity agrees that it will make available 
        (directly or through contributions from other public or 
        private entities) non-Federal contributions toward the 
        activities to be carried out under the grant or 
        contract in an amount equal to $1 for each $5 of 
        Federal funds provided under the grant or contract. 
        Such non-Federal matching funds may be provided 
        directly or through donations from public or private 
        entities and may be in cash or in-kind, fairly 
        evaluated, including plant, equipment, or services.
    (c) Activities of the Centers.--Each Center shall carry out 
the following activities:
            (1) General activities.--Each Center shall--
                    (A) integrate basic, clinical, or health 
                services interdisciplinary research and 
                practice in the development, implementation, 
                and dissemination of evidence-based 
                interventions;
                    (B) involve a broad cross-section of 
                stakeholders, such as researchers, clinicians, 
                consumers, families of consumers, and voluntary 
                health organizations, to develop a research 
                agenda and disseminate findings, and to provide 
                support in the implementation of evidence-based 
                practices;
                    (C) provide training and technical 
                assistance to mental health professionals, and 
                engage in and disseminate translational 
                research with a focus on meeting the needs of 
                individuals with depressive disorders; and
                    (D) educate policy makers, employers, 
                community leaders, and the public about 
                depressive disorders to reduce stigma and raise 
                awareness of treatments.
            (2) Improved treatment standards, clinical 
        guidelines, diagnostic protocols, and care coordination 
        practice.--Each Center shall collaborate with other 
        Centers in the network to--
                    (A) develop and implement treatment 
                standards, clinical guidelines, and protocols 
                that emphasize primary prevention, early 
                intervention, treatment for, and recovery from, 
                depressive disorders;
                    (B) foster communication with other 
                providers attending to co-occurring physical 
                health conditions such as cardiovascular, 
                diabetes, cancer, and substance abuse 
                disorders;
                    (C) leverage available community resources, 
                develop and implement improved self-management 
                programs, and, when appropriate, involve family 
                and other providers of social support in the 
                development and implementation of care plans; 
                and
                    (D) use electronic health records and 
                telehealth technology to better coordinate and 
                manage, and improve access to, care, as 
                determined by the coordinating center.
            (3) Translational research through collaboration of 
        centers and community-based organizations.--Each Center 
        shall--
                    (A) demonstrate effective use of a public-
                private partnership to foster collaborations 
                among members of the network and community-
                based organizations such as community mental 
                health centers and other social and human 
                services providers;
                    (B) expand interdisciplinary, 
                translational, and patient-oriented research 
                and treatment; and
                    (C) coordinate with accredited academic 
                programs to provide ongoing opportunities for 
                the professional and continuing education of 
                mental health providers.
    (d) National Database.--
            (1) In general.--The coordinating center shall 
        establish and maintain a national, publicly available 
        database to improve prevention programs, evidence-based 
        interventions, and disease management programs for 
        depressive disorders, using data collected from the 
        Centers, as described in paragraph (2).
            (2) Data collection.--Each Center shall submit data 
        gathered at such center, as appropriate, to the 
        coordinating center regarding--
                    (A) the prevalence and incidence of 
                depressive disorders;
                    (B) the health and social outcomes of 
                individuals with depressive disorders;
                    (C) the effectiveness of interventions 
                designed, tested, and evaluated;
                    (D) other information, as the Secretary may 
                require.
            (3) Submission of data to the administrator.--The 
        coordinating center shall submit to the Administrator 
        the data and financial information gathered under 
        paragraph (2).
            (4) Publication using data from the database.--A 
        Center, or an individual affiliated with a Center, may 
        publish findings using the data described in paragraph 
        (2) only if such center submits such data to the 
        coordinating center, as required under such paragraph.
    (e) Establishment of Standards; Report Cards and 
Recommendations; Third Party Review.--
            (1) Establishment of standards.--The Secretary, 
        acting through the Administrator, shall establish 
        performance standards for--
                    (A) each Center; and
                    (B) the network of Centers as a whole.
            (2) Report cards.--The Secretary, acting through 
        the Administrator, shall--
                    (A) for each Center, not later than 3 years 
                after the date on which such center of 
                excellence is established and annually 
                thereafter, issue a report card to the 
                coordinating center to rate the performance of 
                such Center; and
                    (B) not later than 3 years after the date 
                on which the first grant is awarded under 
                subsection (b)(1) and annually thereafter, 
                issue a report card to Congress to rate the 
                performance of the network of centers of 
                excellence as a whole.
            (3) Recommendations.--Based upon the report cards 
        described in paragraph (2), the Secretary shall, not 
        later than September 30, 2015--
                    (A) make recommendations to the Centers 
                regarding improvements such centers shall make; 
                and
                    (B) make recommendations to Congress for 
                expanding the Centers to serve individuals with 
                other types of mental disorders.
            (4) Third party review.--Not later than 3 years 
        after the date on which the first grant is awarded 
        under subsection (b)(1) and annually thereafter, the 
        Secretary shall arrange for an independent third party 
        to conduct an evaluation of the network of Centers to 
        ensure that such centers are meeting the goals of this 
        section.
    (f) Authorization of Appropriations.--
            (1) In general.--To carry out this section, there 
        are authorized to be appropriated--
                    (A) $100,000,000 for each of the fiscal 
                years 2011 through 2015; and
                    (B) $150,000,000 for each of the fiscal 
                years 2016 through 2020.
            (2) Allocation of funds authorized.--Of the amount 
        appropriated under paragraph (1) for a fiscal year, the 
        Secretary shall determine the allocation of each Center 
        receiving a grant under this section, but in no case 
        may the allocation be more than $5,000,000, except that 
        the Secretary may allocate not more than $10,000,000 to 
        the coordinating center.

SEC. 520C. [290BB-34] YOUTH INTERAGENCY RESEARCH, TRAINING, AND 
                    TECHNICAL ASSISTANCE CENTERS.

    (a) Program Authorized.--The Secretary, acting through the 
Administrator of the Substance Abuse and Mental Health Services 
Administration, and in consultation with the Administrator of 
the Office of Juvenile Justice and Delinquency Prevention, the 
Director of the Bureau of Justice Assistance and the Director 
of the National Institutes of Health--
            (1) shall award grants or contracts to public or 
        nonprofit private entities to establish not more than 
        four research, training, and technical assistance 
        centers to carry out the activities described in 
        subsection (c); and
            (2) shall award a competitive grant to 1 additional 
        research, training, and technical assistance center to 
        carry out the activities described in subsection (d).
    (b) Application.--A public or private nonprofit entity 
desiring a grant or contract under subsection (a) shall prepare 
and submit an application to the Secretary at such time, in 
such manner, and containing such information as the Secretary 
may require.
    (c) Authorized Activities.--A center established under a 
grant or contract under subsection (a)(1) shall--
            (1) provide training with respect to state-of-the-
        art mental health and justice-related services and 
        successful mental health and substance abuse-justice 
        collaborations that focus on children and adolescents, 
        to public policymakers, law enforcement administrators, 
        public defenders, police, probation officers, judges, 
        parole officials, jail administrators and mental health 
        and substance abuse providers and administrators;
            (2) engage in research and evaluations concerning 
        State and local justice and mental health systems, 
        including system redesign initiatives, and disseminate 
        information concerning the results of such evaluations;
            (3) provide direct technical assistance, including 
        assistance provided through toll-free telephone 
        numbers, concerning issues such as how to accommodate 
        individuals who are being processed through the courts 
        under the Americans with Disabilities Act of 1990 (42 
        U.S.C. 12101 et seq.), what types of mental health or 
        substance abuse service approaches are effective within 
        the judicial system, and how community-based mental 
        health or substance abuse services can be more 
        effective, including relevant regional, ethnic, and 
        gender-related considerations; and
            (4) provide information, training, and technical 
        assistance to State and local governmental officials to 
        enhance the capacity of such officials to provide 
        appropriate services relating to mental health or 
        substance abuse.
    (d) Additional Center.--The additional research, training, 
and technical assistance center established under subsection 
(a)(2) shall provide appropriate information, training, and 
technical assistance to States, political subdivisions of a 
State, Federally recognized Indian tribes, tribal 
organizations, institutions of higher education, public 
organizations, or private nonprofit organizations for--
            (1) the development or continuation of statewide or 
        tribal youth suicide early intervention and prevention 
        strategies;
            (2) ensuring the surveillance of youth suicide 
        early intervention and prevention strategies;
            (3) studying the costs and effectiveness of 
        statewide youth suicide early intervention and 
        prevention strategies in order to provide information 
        concerning relevant issues of importance to State, 
        tribal, and national policymakers;
            (4) further identifying and understanding causes 
        and associated risk factors for youth suicide;
            (5) analyzing the efficacy of new and existing 
        youth suicide early intervention techniques and 
        technology;
            (6) ensuring the surveillance of suicidal behaviors 
        and nonfatal suicidal attempts;
            (7) studying the effectiveness of State-sponsored 
        statewide and tribal youth suicide early intervention 
        and prevention strategies on the overall wellness and 
        health promotion strategies related to suicide 
        attempts;
            (8) promoting the sharing of data regarding youth 
        suicide with Federal agencies involved with youth 
        suicide early intervention and prevention, and State-
        sponsored statewide or tribal youth suicide early 
        intervention and prevention strategies for the purpose 
        of identifying previously unknown mental health causes 
        and associated risk factors for suicide in youth;
            (9) evaluating and disseminating outcomes and best 
        practices of mental and behavioral health services at 
        institutions of higher education; and
            (10) other activities determined appropriate by the 
        Secretary.
    (e) Authorization of Appropriations.--
            (1) For the purpose of awarding grants or contracts 
        under subsection (a)(1), there is authorized to be 
        appropriated $4,000,000 for fiscal year 2001, and such 
        sums as may be necessary for fiscal years 2002 and 
        2003.
            (2) For the purpose of awarding a grant under 
        subsection (a)(2), there are authorized to be 
        appropriated $3,000,000 for fiscal year 2005, 
        $4,000,000 for fiscal year 2006, and $5,000,000 for 
        fiscal year 2007.

SEC. 520D. [290BB-35] SERVICES FOR YOUTH OFFENDERS.

    (a) In General.--The Secretary, acting through the Director 
of the Center for Mental Health Services, and in consultation 
with the Director of the Center for Substance Abuse Treatment, 
the Administrator of the Office of Juvenile Justice and 
Delinquency Prevention, and the Director of the Special 
Education Programs, shall award grants on a competitive basis 
to State or local juvenile justice agencies to enable such 
agencies to provide aftercare services for youth offenders who 
have been discharged from facilities in the juvenile or 
criminal justice system and have serious emotional disturbances 
or are at risk of developing such disturbances.
    (b) Use of Funds.--A State or local juvenile justice agency 
receiving a grant under subsection (a) shall use the amounts 
provided under the grant--
            (1) to develop a plan describing the manner in 
        which the agency will provide services for each youth 
        offender who has a serious emotional disturbance and 
        has been detained or incarcerated in facilities within 
        the juvenile or criminal justice system;
            (2) to provide a network of core or aftercare 
        services or access to such services for each youth 
        offender, including diagnostic and evaluation services, 
        substance abuse treatment services, outpatient mental 
        health care services, medication management services, 
        intensive home-based therapy, intensive day treatment 
        services, respite care, and therapeutic foster care;
            (3) to establish a program that coordinates with 
        other State and local agencies providing recreational, 
        social, educational, vocational, or operational 
        services for youth, to enable the agency receiving a 
        grant under this section to provide community-based 
        system of care services for each youth offender that 
        addresses the special needs of the youth and helps the 
        youth access all of the aforementioned services; and
            (4) using not more than 20 percent of funds 
        received, to provide planning and transition services 
        as described in paragraph (3) for youth offenders while 
        such youth are incarcerated or detained.
    (c) Application.--A State or local juvenile justice agency 
that desires a grant under subsection (a) shall submit an 
application to the Secretary at such time, in such manner, and 
accompanied by such information as the Secretary may reasonably 
require.
    (d) Report.--Not later than 3 years after the date of the 
enactment of this section and annually thereafter, the 
Secretary shall prepare and submit, to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee 
on Commerce of the House of Representatives, a report that 
describes the services provided pursuant to this section.
    (e) Definitions.--In this section:
            (1) Serious emotional disturbance.--The term 
        ``serious emotional disturbance'' with respect to a 
        youth offender means an offender who currently, or at 
        any time within the 1-year period ending on the day on 
        which services are sought under this section, has a 
        diagnosable mental, behavioral, or emotional disorder 
        that functionally impairs the offender's life by 
        substantially limiting the offender's role in family, 
        school, or community activities, and interfering with 
        the offender's ability to achieve or maintain one or 
        more developmentally-appropriate social, behavior, 
        cognitive, communicative, or adaptive skills.
            (2) Community-based system of care.--The term 
        ``community-based system of care'' means the provision 
        of services for the youth offender by various State or 
        local agencies that in an interagency fashion or 
        operating as a network addresses the recreational, 
        social, educational, vocational, mental health, 
        substance abuse, and operational needs of the youth 
        offender.
            (3) Youth offender.--The term ``youth offender'' 
        means an individual who is 21 years of age or younger 
        who has been discharged from a State or local juvenile 
        or criminal justice system, except that if the 
        individual is between the ages of 18 and 21 years, such 
        individual has had contact with the State or local 
        juvenile or criminal justice system prior to attaining 
        18 years of age and is under the jurisdiction of such a 
        system at the time services are sought.
    (f ) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section $40,000,000 for 
fiscal year 2001, and such sums as may be necessary for each of 
fiscal years 2002 and 2003.

SEC. 520E. [290BB-36] YOUTH SUICIDE EARLY INTERVENTION AND PREVENTION 
                    STRATEGIES.

    (a) In General.--The Secretary, acting through the 
Administrator of the Substance Abuse and Mental Health Services
Administration, shall award grants or cooperative agreements to 
eligible entities to--
            (1) develop and implement State-sponsored statewide 
        or tribal youth suicide early intervention and 
        prevention strategies in schools, educational 
        institutions, juvenile justice systems, substance abuse 
        programs, mental health programs, foster care systems, 
        and other child and youth support organizations;
            (2) support public organizations and private 
        nonprofit organizations actively involved in State-
        sponsored statewide or tribal youth suicide early 
        intervention and prevention strategies and in the 
        development and continuation of State-sponsored 
        statewide youth suicide early intervention and 
        prevention strategies;
            (3) provide grants to institutions of higher 
        education to coordinate the implementation of State-
        sponsored statewide or tribal youth suicide early 
        intervention and prevention strategies;
            (4) collect and analyze data on State-sponsored 
        statewide or tribal youth suicide early intervention 
        and prevention services that can be used to monitor the 
        effectiveness of such services and for research, 
        technical assistance, and policy development; and
            (5) assist eligible entities, through State-
        sponsored statewide or tribal youth suicide early 
        intervention and prevention strategies, in achieving 
        targets for youth suicide reductions under title V of 
        the Social Security Act.
    (b) Eligible Entity.--
            (1) Definition.--In this section, the term 
        ``eligible entity'' means--
                    (A) a State;
                    (B) a public organization or private 
                nonprofit organization designated by a State to 
                develop or direct the State-sponsored statewide 
                youth suicide early intervention and prevention 
                strategy; or
                    (C) a Federally recognized Indian tribe or 
                tribal organization (as defined in the Indian 
                Self-Determination and Education Assistance 
                Act) or an urban Indian organization (as 
                defined in the Indian Health Care Improvement 
                Act) that is actively involved in the 
                development and continuation of a tribal youth 
                suicide early intervention and prevention 
                strategy.
            (2) Limitation.--In carrying out this section, the 
        Secretary shall ensure that each State is awarded only 
        1 grant or cooperative agreement under this section. 
        For purposes of the preceding sentence, a State shall 
        be considered to have been awarded a grant or 
        cooperative agreement if the eligible entity involved 
        is the State or an entity designated by the State under 
        paragraph (1)(B). Nothing in this paragraph shall be 
        construed to apply to entities described in paragraph 
        (1)(C).
    (c) Preference.--In providing assistance under a grant or 
cooperative agreement under this section, an eligible entity 
shall give preference to public organizations, private 
nonprofit organizations, political subdivisions, institutions 
of higher education, and tribal organizations actively involved 
with the State-sponsored statewide or tribal youth suicide 
early intervention and prevention strategy that--
            (1) provide early intervention and assessment 
        services, including screening programs, to youth who 
        are at risk for mental or emotional disorders that may 
        lead to a suicide attempt, and that are integrated with 
        school systems, educational institutions, juvenile 
        justice systems, substance abuse programs, mental 
        health programs, foster care systems, and other child 
        and youth support organizations;
            (2) demonstrate collaboration among early 
        intervention and prevention services or certify that 
        entities will engage in future collaboration;
            (3) employ or include in their applications a 
        commitment to evaluate youth suicide early intervention 
        and prevention practices and strategies adapted to the 
        local community;
            (4) provide timely referrals for appropriate 
        community-based mental health care and treatment of 
        youth who are at risk for suicide in child-serving 
        settings and agencies;
            (5) provide immediate support and information 
        resources to families of youth who are at risk for 
        suicide;
            (6) offer access to services and care to youth with 
        diverse linguistic and cultural backgrounds;
            (7) offer appropriate postsuicide intervention 
        services, care, and information to families, friends, 
        schools, educational institutions, juvenile justice 
        systems, substance abuse programs, mental health 
        programs, foster care systems, and other child and 
        youth support organizations of youth who recently 
        completed suicide;
            (8) offer continuous and up-to-date information and 
        awareness campaigns that target parents, family 
        members, child care professionals, community care 
        providers, and the general public and highlight the 
        risk factors associated with youth suicide and the 
        life-saving help and care available from early 
        intervention and prevention services;
            (9) ensure that information and awareness campaigns 
        on youth suicide risk factors, and early intervention 
        and prevention services, use effective communication 
        mechanisms that are targeted to and reach youth, 
        families, schools, educational institutions, and youth 
        organizations;
            (10) provide a timely response system to ensure 
        that child-serving professionals and providers are 
        properly trained in youth suicide early intervention 
        and prevention strategies and that child-serving 
        professionals and providers involved in early 
        intervention and prevention services are properly 
        trained in effectively identifying youth who are at 
        risk for suicide;
            (11) provide continuous training activities for 
        child care professionals and community care providers 
        on the latest youth suicide early intervention and 
        prevention services practices and strategies;
            (12) conduct annual self-evaluations of outcomes 
        and activities, including consulting with interested 
        families and advocacy organizations;
            (13) provide services in areas or regions with 
        rates of youth suicide that exceed the national average 
        as determined by the Centers for Disease Control and 
        Prevention; and
            (14) obtain informed written consent from a parent 
        or legal guardian of an at-risk child before involving 
        the child in a youth suicide early intervention and 
        prevention program.
    (d) Requirement for Direct Services.--Not less than 85 
percent of grant funds received under this section shall be 
used to provide direct services, of which not less than 5 
percent shall be used for activities authorized under 
subsection (a)(3).
    (e) Coordination and Collaboration.--
            (1) In general.--In carrying out this section, the 
        Secretary shall collaborate with relevant Federal 
        agencies and suicide working groups responsible for 
        early intervention and prevention services relating to 
        youth suicide.
            (2) Consultation.--In carrying out this section, 
        the Secretary shall consult with--
                    (A) State and local agencies, including 
                agencies responsible for early intervention and 
                prevention services under title XIX of the 
                Social Security Act, the State Children's 
                Health Insurance Program under title XXI of the 
                Social Security Act, and programs funded by 
                grants under title V of the Social Security 
                Act;
                    (B) local and national organizations that 
                serve youth at risk for suicide and their 
                families;
                    (C) relevant national medical and other 
                health and education specialty organizations;
                    (D) youth who are at risk for suicide, who 
                have survived suicide attempts, or who are 
                currently receiving care from early 
                intervention services;
                    (E) families and friends of youth who are 
                at risk for suicide, who have survived suicide 
                attempts, who are currently receiving care from 
                early intervention and prevention services, or 
                who have completed suicide;
                    (F) qualified professionals who possess the 
                specialized knowledge, skills, experience, and 
                relevant attributes needed to serve youth at 
                risk for suicide and their families; and
                    (G) third-party payers, managed care 
                organizations, and related commercial 
                industries.
            (3) Policy development.--In carrying out this 
        section, the Secretary shall--
                    (A) coordinate and collaborate on policy 
                development at the Federal level with the 
                relevant Department of Health and Human 
                Services agencies and suicide working groups; 
                and
                    (B) consult on policy development at the 
                Federal level with the private sector, 
                including consumer, medical, suicide prevention 
                advocacy groups, and other health and education 
                professional-based organizations, with respect 
                to State-sponsored statewide or tribal youth 
                suicide early intervention and prevention 
                strategies.
    (f) Rule of Construction; Religious and Moral 
Accommodation.--Nothing in this section shall be construed to 
require suicide assessment, early intervention, or treatment 
services for youth whose parents or legal guardians object 
based on the parents' or legal guardians' religious beliefs or 
moral objections.
    (g) Evaluations and Report.--
            (1) Evaluations by eligible entities.--Not later 
        than 18 months after receiving a grant or cooperative 
        agreement under this section, an eligible entity shall 
        submit to the Secretary the results of an evaluation to 
        be conducted by the entity concerning the effectiveness 
        of the activities carried out under the grant or 
        agreement.
            (2) Report.--Not later than 2 years after the date 
        of enactment of this section, the Secretary shall 
        submit to the appropriate committees of Congress a 
        report concerning the results of--
                    (A) the evaluations conducted under 
                paragraph (1); and
                    (B) an evaluation conducted by the 
                Secretary to analyze the effectiveness and 
                efficacy of the activities conducted with 
                grants, collaborations, and consultations under 
                this section.
    (h) Rule of Construction; Student Medication.--Nothing in 
this section or section 520E-1 shall be construed to allow 
school personnel to require that a student obtain any 
medication as a condition of attending school or receiving 
services.
    (i) Prohibition.--Funds appropriated to carry out this 
section, section 520C, section 520E-1, or section 520E-2 shall 
not be used to pay for or refer for abortion.
    (j) Parental consent.--States and entities receiving 
funding under this section and section 520E-1 shall obtain 
prior written, informed consent from the child's parent or 
legal guardian for assessment services, school-sponsored 
programs, and treatment involving medication related to youth 
suicide conducted in elementary and secondary schools. The 
requirement of the preceding sentence does not apply in the 
following cases:
            (1) In an emergency, where it is necessary to 
        protect the immediate health and safety of the student 
        or other students.
            (2) Other instances, as defined by the State, where 
        parental consent cannot reasonably be obtained.
    (k) Relation to Education Provisions.--Nothing in this 
section or section 520E-1 shall be construed to supersede 
section 444 of the General Education Provisions Act, including 
the requirement of prior parental consent for the disclosure of 
any education records. Nothing in this section or section 520E-
1 shall be construed to modify or affect parental notification 
requirements for programs authorized under the Elementary and 
Secondary Education Act of 1965 (as amended by the No Child 
Left Behind Act of 2001; Public Law 107-110).
    (l) Definitions.--In this section:
            (1) Early intervention.--The term ``early 
        intervention'' means a strategy or approach that is 
        intended to prevent an outcome or to alter the course 
        of an existing condition.
            (2) Educational institution; institution of higher 
        education; school.--The term--
                    (A) ``educational institution'' means a 
                school or institution of higher education;
                    (B) ``institution of higher education'' has 
                the meaning given such term in section 101 of 
                the Higher Education Act of 1965; and
                    (C) ``school'' means an elementary or 
                secondary school (as such terms are defined in 
                section 9101 of the Elementary and Secondary 
                Education Act of 1965).
            (3) Prevention.--The term ``prevention'' means a 
        strategy or approach that reduces the likelihood or 
        risk of onset, or delays the onset, of adverse health 
        problems that have been known to lead to suicide.
            (4) Youth.--The term ``youth'' means individuals 
        who are between 10 and 24 years of age.
    (m) Authorization of Appropriations.--
            (1) In general.--For the purpose of carrying out 
        this section, there are authorized to be appropriated 
        $7,000,000 for fiscal year 2005, $18,000,000 for fiscal 
        year 2006, and $30,000,000 for fiscal year 2007.
            (2) Preference.--If less than $3,500,000 is 
        appropriated for any fiscal year to carry out this 
        section, in awarding grants and cooperative agreements 
        under this section during the fiscal year, the 
        Secretary shall give preference to States that have 
        rates of suicide that significantly exceed the national 
        average as determined by the Centers for Disease 
        Control and Prevention.

SEC. 520E-1. [290BB-36A] SUICIDE PREVENTION FOR CHILDREN AND 
                    ADOLESCENTS \1\.
---------------------------------------------------------------------------

    \1\ The probable intent of the Congress is that the heading be 
``SUICIDE PREVENTION FOR YOUTH''. See the amendment described in 
section 3(b)(1)(A) of Public Law 108-355 (118 Stat. 1407). The 
amendment cannot be executed because the matter in the heading to be 
struck does not appear, as the amendatory instruction used the wrong 
font. The amendment referred to ``CHILDREN AND ADOLESCENTS'' rather 
than ``CHILDREN AND ADOLESCENTS''. (The amendment is directed to 
section ``520E''. Section 520E-1 above formerly was section 520E, and 
was redesignated by section 3(b)(2) of such Public Law.)
---------------------------------------------------------------------------
    (a) In General.--The Secretary shall award grants or
cooperative agreements to public organizations, private 
nonprofit organizations, political subdivisions, consortia of 
political subdivisions, consortia of States, or Federally 
recognized Indian tribes or tribal organizations to design 
early intervention and prevention strategies that will 
complement the State-sponsored statewide or tribal youth 
suicide early intervention and prevention strategies developed 
pursuant to section 520E.
    (b) Collaboration.--In carrying out subsection (a), the 
Secretary shall ensure that activities under this section are 
coordinated with the relevant Department of Health and Human 
Services agencies and suicide working groups.
    (c) Requirements.--A public organization, private nonprofit 
organization, political subdivision, consortium of political 
subdivisions, consortium of States, or federally recognized 
Indian tribe or tribal organization desiring a grant, contract, 
or cooperative agreement under this section shall demonstrate 
that the suicide prevention program such entity proposes will--
            (1)(A) comply with the State-sponsored statewide 
        early intervention and prevention strategy as developed 
        under section 520E; and
            (B) in the case of a consortium of States, receive 
        the support of all States involved;
            (2) provide for the timely assessment, treatment, 
        or referral for mental health or substance abuse 
        services of youth at risk for suicide;
            (3) be based on suicide prevention practices and 
        strategies that are adapted to the local community;
            (4) integrate its suicide prevention program into 
        the existing health care system in the community 
        including general, mental, and behavioral health 
        services, and substance abuse services;
            (5) be integrated into other systems in the 
        community that address the needs of youth including the 
        school systems, educational institutions, juvenile 
        justice system, substance abuse programs, mental health 
        programs, foster care systems, and community child and 
        youth support organizations;
            (6) use primary prevention methods to educate and 
        raise awareness in the local community by disseminating 
        evidence-based information about suicide prevention;
            (7) include suicide prevention, mental health, and 
        related information and services for the families and 
        friends of those who completed suicide, as needed;
            (8) offer access to services and care to youth with 
        diverse linguistic and cultural backgrounds;
            (9) conduct annual self-evaluations of outcomes and 
        activities, including consulting with interested 
        families and advocacy organizations; \1\
---------------------------------------------------------------------------
    \1\ So in law. Probably should include ``and'' after the semicolon 
at the end of paragraph (9). See section 3(b)(1)(D)(ix) of Public Law 
108-355 (118 Stat. 1408).
---------------------------------------------------------------------------
            (10) ensure that staff used in the program are 
        trained in suicide prevention and that professionals 
        involved in the system of care have received training 
        in identifying persons at risk of suicide.
    (d) Use of Funds.--Amounts provided under a grant or 
cooperative agreement under this section shall be used to 
supplement, and not supplant, Federal and non-Federal funds 
available for carrying out the activities described in this 
section. Applicants shall provide financial information to 
demonstrate compliance with this section.
    (e) Condition.--An applicant for a grant or cooperative 
agreement under subsection (a) shall demonstrate to the 
Secretary that the application complies with the State-
sponsored statewide early intervention and prevention strategy 
as developed under section 520E and the applicant has the 
support of the local community and relevant public health 
officials.
    (f ) Special Populations.--In awarding grants and 
cooperative agreements under subsection (a), the Secretary 
shall ensure that such awards are made in a manner that will 
focus on the needs of communities or groups that experience 
high or rapidly rising rates of suicide.
    (g) Application.--A public organization, private nonprofit 
organization, political subdivision, consortium of political 
subdivisions, consortium of States, or Federally recognized 
Indian tribe or tribal organization receiving a grant or 
cooperative agreement under subsection (a) shall prepare and 
submit an application to the Secretary at such time, in such 
manner, and containing such information as the Secretary may 
reasonably require. Such application shall include a plan for 
the rigorous evaluation of activities funded under the grant or 
cooperative agreement, including a process and outcome 
evaluation.
    (h) Distribution of Awards.--In awarding grants and 
cooperative agreements under subsection (a), the Secretary 
shall ensure that such awards are distributed among the 
geographical regions of the United States and between urban and 
rural settings.
    (i) Evaluation.--A public organization, private nonprofit 
organization, political subdivision, consortium of political 
subdivisions, consortium of States, or Federally recognized 
Indian tribe or tribal organization receiving a grant or 
cooperative agreement under subsection (a) shall prepare and 
submit to the Secretary at the end of the program period, an 
evaluation of all activities funded under this section.
    ( j) Dissemination and Education.--The Secretary shall 
ensure that findings derived from activities carried out under 
this section are disseminated to State, county and local 
governmental agencies and public and private nonprofit 
organizations active in promoting suicide prevention and family 
support activities.
    (k) Duration of Projects.--With respect to a grant, 
contract, or cooperative agreement \1\ awarded under this 
section, the period during which payments under such award may 
be made to the recipient may not exceed 3 years.
---------------------------------------------------------------------------
    \1\ So in law. Probably should be ``grant or cooperative 
agreement''. See the amendments made by section 3(b) of Public Law 108-
355 (118 Stat. 1407).
---------------------------------------------------------------------------
    (l) Study.--Within 1 year after the date of the enactment 
of this section, the Secretary shall, directly or by grant or 
contract, initiate a study to assemble and analyze data to 
identify--
            (1) unique profiles of children under 13 who 
        attempt or complete suicide;
            (2) unique profiles of youths between ages 13 and 
        24 who attempt or complete suicide; and
            (3) a profile of services available to these groups 
        and the use of these services by children and youths 
        from paragraphs (1) and (2).
    (m) Definitions.--In this section, the terms ``early 
intervention'', ``educational institution'', ``institution of 
higher education'', ``prevention'', ``school'', and ``youth'' 
have the meanings given to those terms in section 520E.
    (n) Authorization of Appropriation.--For purposes of 
carrying out this section, there is authorized to be 
appropriated $75,000,000 for fiscal year 2001 and such sums as 
may be necessary for each of the fiscal years 2002 through 
2003.

SEC. 520E-2. [290BB-36B] MENTAL AND BEHAVIORAL HEALTH SERVICES ON 
                    CAMPUS.

    (a) In General.--The Secretary, acting through the Director 
of the Center for Mental Health Services, in consultation with 
the Secretary of Education, may award grants on a competitive 
basis to institutions of higher education to enhance services 
for students with mental and behavioral health problems that 
can lead to school failure, such as depression, substance 
abuse, and suicide attempts, so that students will successfully 
complete their studies.
    (b) Use of Funds.--The Secretary may not make a grant to an 
institution of higher education under this section unless the 
institution agrees to use the grant only for--
            (1) educational seminars;
            (2) the operation of hot lines;
            (3) preparation of informational material;
            (4) preparation of educational materials for 
        families of students to increase awareness of potential 
        mental and behavioral health issues of students 
        enrolled at the institution of higher education;
            (5) training programs for students and campus 
        personnel to respond effectively to students with 
        mental and behavioral health problems that can lead to 
        school failure, such as depression, substance abuse, 
        and suicide attempts; or
            (6) the creation of a networking infrastructure to 
        link colleges and universities that do not have mental 
        health services with health care providers who can 
        treat mental and behavioral health problems.
    (c) Eligible grant recipients.--Any institution of higher 
education receiving a grant under this section may carry out 
activities under the grant through--
            (1) college counseling centers;
            (2) college and university psychological service 
        centers;
            (3) mental health centers;
            (4) psychology training clinics; or
            (5) institution of higher education supported, 
        evidence-based, mental health and substance abuse 
        programs.
    (d) Application.--An institution of higher education 
desiring a grant under this section shall prepare and submit an 
application to the Secretary at such time and in such manner as 
the Secretary may require. At a minimum, the application shall 
include the following:
            (1) A description of identified mental and 
        behavioral health needs of students at the institution 
        of higher education.
            (2) A description of Federal, State, local, 
        private, and institutional resources currently 
        available to address the needs described in paragraph 
        (1) at the institution of higher education.
            (3) A description of the outreach strategies of the 
        institution of higher education for promoting access to 
        services, including a proposed plan for reaching those 
        students most in need of mental health services.
            (4) A plan to evaluate program outcomes, including 
        a description of the proposed use of funds, the program 
        objectives, and how the objectives will be met.
            (5) An assurance that the institution will submit a 
        report to the Secretary each fiscal year on the 
        activities carried out with the grant and the results 
        achieved through those activities.
    (e) Requirement of Matching Funds.--
            (1) In general.--The Secretary may make a grant 
        under this section to an institution of higher 
        education only if the institution agrees to make 
        available (directly or through donations from public or 
        private entities) non-Federal contributions in an 
        amount that is not less than $1 for each $1 of Federal 
        funds provided in the grant, toward the costs of 
        activities carried out with the grant (as described in 
        subsection (b)) and other activities by the institution 
        to reduce student mental and behavioral health 
        problems.
            (2) Determination of amount contributed.--Non-
        Federal contributions required under paragraph (1) may 
        be in cash or in kind. Amounts provided by the Federal 
        Government, or services assisted or subsidized to any 
        significant extent by the Federal Government, may not 
        be included in determining the amount of such non-
        Federal contributions.
            (3) Waiver.--The Secretary may waive the 
        requirement established in paragraph (1) with respect 
        to an institution of higher education if the Secretary 
        determines that extraordinary need at the institution 
        justifies the waiver.
    (f) Reports.--For each fiscal year that grants are awarded 
under this section, the Secretary shall conduct a study on the 
results of the grants and submit to the Congress a report on 
such results that includes the following:
            (1) An evaluation of the grant program outcomes, 
        including a summary of activities carried out with the 
        grant and the results achieved through those 
        activities.
            (2) Recommendations on how to improve access to 
        mental and behavioral health services at institutions 
        of higher education, including efforts to reduce the 
        incidence of suicide and substance abuse.
    (g) Definition.--In this section, the term ``institution of 
higher education'' has the meaning given such term in section 
101 of the Higher Education Act of 1965.
    (h) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated $5,000,000 for fiscal year 2005, $5,000,000 for 
fiscal year 2006, and $5,000,000 for fiscal year 2007.

SEC. 520F. [290BB-37] GRANTS FOR EMERGENCY MENTAL HEALTH CENTERS.

    (a) Program Authorized.--The Secretary shall award grants 
to States, political subdivisions of States, Indian tribes, and 
tribal organizations to support the designation of hospitals 
and health centers as Emergency Mental Health Centers.
    (b) Health Center.--In this section, the term ``health 
center'' has the meaning given such term in section 330, and 
includes community health centers and community mental health 
centers.
    (c) Distribution of Awards.--The Secretary shall ensure 
that such grants awarded under subsection (a) are equitably 
distributed among the geographical regions of the United 
States, between urban and rural populations, and between 
different settings of care including health centers, mental 
health centers, hospitals, and other psychiatric units or 
facilities.
    (d) Application.--A State, political subdivision of a 
State, Indian tribe, or tribal organization that desires a 
grant under subsection (a) shall submit an application to the 
Secretary at such time, in such manner, and containing such 
information as the Secretary may require, including a plan for 
the rigorous evaluation of activities carried out with funds 
received under this section.
    (e) Use of Funds.--
            (1) In general.--A State, political subdivision of 
        a State, Indian tribe, or tribal organization receiving 
        a grant under subsection (a) shall use funds from such 
        grant to establish or designate hospitals and health 
        centers as Emergency Mental Health Centers.
            (2) Emergency mental health centers.--Such 
        Emergency Mental Health Centers described in paragraph 
        (1)--
                    (A) shall--
                            (i) serve as a central receiving 
                        point in the community for individuals 
                        who may be in need of emergency mental 
                        health services;
                            (ii) purchase, if needed, any 
                        equipment necessary to evaluate, 
                        diagnose and stabilize an individual 
                        with a mental illness;
                            (iii) provide training, if needed, 
                        to the medical personnel staffing the 
                        Emergency Mental Health Center to 
                        evaluate, diagnose, stabilize, and 
                        treat an individual with a mental 
                        illness; and
                            (iv) provide any treatment that is 
                        necessary for an individual with a 
                        mental illness or a referral for such 
                        individual to another facility where 
                        such treatment may be received; and
                    (B) may establish and train a mobile crisis 
                intervention team to respond to mental health 
                emergencies within the community.
    (f ) Evaluation.--A State, political subdivision of a 
State, Indian tribe, or tribal organization that receives a 
grant under subsection (a) shall prepare and submit an 
evaluation to the Secretary at such time, in such manner, and 
containing such information as the Secretary may reasonably 
require, including an evaluation of activities carried out with 
funds received under this section and a process and outcomes 
evaluation.
    (g) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section, $25,000,000 for 
fiscal year 2001 and such sums as may be necessary for each of 
the fiscal years 2002 through 2003.

SEC. 520G. [290BB-38] GRANTS FOR JAIL DIVERSION PROGRAMS.

    (a) Program Authorized.--The Secretary shall make up to 125 
grants to States, political subdivisions of States, Indian 
tribes, and tribal organizations, acting directly or through 
agreements with other public or nonprofit entities, to develop 
and implement programs to divert individuals with a mental 
illness from the criminal justice system to community-based 
services.
    (b) Administration.--
            (1) Consultation.--The Secretary shall consult with 
        the Attorney General and any other appropriate 
        officials in carrying out this section.
            (2) Regulatory authority.--The Secretary shall 
        issue regulations and guidelines necessary to carry out 
        this section, including methodologies and outcome 
        measures for evaluating programs carried out by States, 
        political subdivisions of States, Indian tribes, and 
        tribal organizations receiving grants under subsection 
        (a).
    (c) Applications.--
            (1) In general.--To receive a grant under 
        subsection (a), the chief executive of a State, chief 
        executive of a subdivision of a State, Indian tribe or 
        tribal organization shall prepare and submit an 
        application to the Secretary at such time, in such 
        manner, and containing such information as the 
        Secretary shall reasonably require.
            (2) Content.--Such application shall--
                    (A) contain an assurance that--
                            (i) community-based mental health 
                        services will be available for the 
                        individuals who are diverted from the 
                        criminal justice system, and that such 
                        services are based on the best known 
                        practices, reflect current research 
                        findings, include case management, 
                        assertive community treatment, 
                        medication management and access, 
                        integrated mental health and co-
                        occurring substance abuse treatment, 
                        and psychiatric rehabilitation, and 
                        will be coordinated with social 
                        services, including life skills 
                        training, housing placement, vocational 
                        training, education job placement, and 
                        health care;
                            (ii) there has been relevant 
                        interagency collaboration between the 
                        appropriate criminal justice, mental 
                        health, and substance abuse systems; 
                        and
                            (iii) the Federal support provided 
                        will be used to supplement, and not 
                        supplant, State, local, Indian tribe, 
                        or tribal organization sources of 
                        funding that would otherwise be 
                        available;
                    (B) demonstrate that the diversion program 
                will be integrated with an existing system of 
                care for those with mental illness;
                    (C) explain the applicant's inability to 
                fund the program adequately without Federal 
                assistance;
                    (D) specify plans for obtaining necessary 
                support and continuing the proposed program 
                following the conclusion of Federal support; 
                and
                    (E) describe methodology and outcome 
                measures that will be used in evaluating the 
                program.
    (d) Use of Funds.--A State, political subdivision of a 
State, Indian tribe, or tribal organization that receives a 
grant under subsection (a) may use funds received under such 
grant to--
            (1) integrate the diversion program into the 
        existing system of care;
            (2) create or expand community-based mental health 
        and co-occurring mental illness and substance abuse 
        services to accommodate the diversion program;
            (3) train professionals involved in the system of 
        care, and law enforcement officers, attorneys, and 
        judges; and
            (4) provide community outreach and crisis 
        intervention.
    (e) Federal Share.--
            (1) In general.--The Secretary shall pay to a 
        State, political subdivision of a State, Indian tribe, 
        or tribal organization receiving a grant under 
        subsection (a) the Federal share of the cost of 
        activities described in the application.
            (2) Federal share.--The Federal share of a grant 
        made under this section shall not exceed 75 percent of 
        the total cost of the program carried out by the State, 
        political subdivision of a State, Indian tribe, or 
        tribal organization. Such share shall be used for new 
        expenses of the program carried out by such State, 
        political subdivision of a State, Indian tribe, or 
        tribal organization.
            (3) Non-federal share.--The non-Federal share of 
        payments made under this section may be made in cash or 
        in kind fairly evaluated, including planned equipment 
        or services. The Secretary may waive the requirement of 
        matching contributions.
    (f ) Geographic Distribution.--The Secretary shall ensure 
that such grants awarded under subsection (a) are equitably 
distributed among the geographical regions of the United States 
and between urban and rural populations.
    (g) Training and Technical Assistance.--Training and 
technical assistance may be provided by the Secretary to assist 
a State, political subdivision of a State, Indian tribe, or 
tribal organization receiving a grant under subsection (a) in 
establishing and operating a diversion program.
    (h) Evaluations.--The programs described in subsection (a) 
shall be evaluated not less than one time in every 12-month 
period using the methodology and outcome measures identified in 
the grant application.
    (i) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section $10,000,000 for 
fiscal year 2001, and such sums as may be necessary for fiscal 
years 2002 through 2003.

SEC. 520H. [290BB-39] IMPROVING OUTCOMES FOR CHILDREN AND ADOLESCENTS 
                    THROUGH SERVICES INTEGRATION BETWEEN CHILD WELFARE 
                    AND MENTAL HEALTH SERVICES.

    (a) In General.--The Secretary shall award grants, 
contracts or cooperative agreements to States, political 
subdivisions of States, Indian tribes, and tribal organizations 
to provide integrated child welfare and mental health services 
for children and adolescents under 19 years of age in the child 
welfare system or at risk for becoming part of the system, and 
parents or caregivers with a mental illness or a mental illness 
and a co-occurring substance abuse disorder.
    (b) Duration.--With respect to a grant, contract or 
cooperative agreement awarded under this section, the period 
during which payments under such award are made to the 
recipient may not exceed 5 years.
    (c) Application.--
            (1) In general.--To be eligible to receive an award 
        under subsection (a), a State, political subdivision of 
        a State, Indian tribe, or tribal organization shall 
        submit an application to the Secretary at such time, in 
        such manner, and accompanied by such information as the 
        Secretary may reasonably require.
            (2) Content.--An application submitted under 
        paragraph (1) shall--
                    (A) describe the program to be funded under 
                the grant, contract or cooperative agreement;
                    (B) explain how such program reflects best 
                practices in the provision of child welfare and 
                mental health services; and
                    (C) provide assurances that--
                            (i) persons providing services 
                        under the grant, contract or 
                        cooperative agreement are adequately 
                        trained to provide such services; and
                            (ii) the services will be provided 
                        in accordance with subsection (d).
    (d) Use of Funds.--A State, political subdivision of a 
State, Indian tribe, or tribal organization that receives a 
grant, contract, or cooperative agreement under subsection (a) 
shall use amounts made available through such grant, contract 
or cooperative agreement to--
            (1) provide family-centered, comprehensive, and 
        coordinated child welfare and mental health services, 
        including prevention, early intervention and treatment 
        services for children and adolescents, and for their 
        parents or caregivers;
            (2) ensure a single point of access for such 
        coordinated services;
            (3) provide integrated mental health and substance 
        abuse treatment for children, adolescents, and parents 
        or caregivers with a mental illness and a co-occurring 
        substance abuse disorder;
            (4) provide training for the child welfare, mental 
        health and substance abuse professionals who will 
        participate in the program carried out under this 
        section;
            (5) provide technical assistance to child welfare 
        and mental health agencies;
            (6) develop cooperative efforts with other service 
        entities in the community, including education, social 
        services, juvenile justice, and primary health care 
        agencies;
            (7) coordinate services with services provided 
        under the Medicaid program and the State Children's 
        Health Insurance Program under titles XIX and XXI of 
        the Social Security Act;
            (8) provide linguistically appropriate and 
        culturally competent services; and
            (9) evaluate the effectiveness and cost-efficiency 
        of the integrated services that measure the level of 
        coordination, outcome measures for parents or 
        caregivers with a mental illness or a mental illness 
        and a co-occurring substance abuse disorder, and 
        outcome measures for children.
    (e) Distribution of Awards.--The Secretary shall ensure 
that grants, contracts, and cooperative agreements awarded 
under subsection (a) are equitably distributed among the 
geographical regions of the United States and between urban and 
rural populations.
    (f ) Evaluation.--The Secretary shall evaluate each program 
carried out by a State, political subdivision of a State, 
Indian tribe, or tribal organization under subsection (a) and 
shall disseminate the findings with respect to each such 
evaluation to appropriate public and private entities.
    (g) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section, $10,000,000 for 
fiscal year 2001, and such sums as may be necessary for each of 
fiscal years 2002 and 2003.

SEC. 520I. [290BB-40] GRANTS FOR THE INTEGRATED TREATMENT OF SERIOUS 
                    MENTAL ILLNESS AND CO-OCCURRING SUBSTANCE ABUSE.

    (a) In General.--The Secretary shall award grants, 
contracts, or cooperative agreements to States, political 
subdivisions of States, Indian tribes, tribal organizations, 
and private nonprofit organizations for the development or 
expansion of programs to provide integrated treatment services 
for individuals with a serious mental illness and a co-
occurring substance abuse disorder.
    (b) Priority.--In awarding grants, contracts, and 
cooperative agreements under subsection (a), the Secretary 
shall give priority to applicants that emphasize the provision 
of services for individuals with a serious mental illness and a 
co-occurring substance abuse disorder who--
            (1) have a history of interactions with law 
        enforcement or the criminal justice system;
            (2) have recently been released from incarceration;
            (3) have a history of unsuccessful treatment in 
        either an inpatient or outpatient setting;
            (4) have never followed through with outpatient 
        services despite repeated referrals; or
            (5) are homeless.
    (c) Use of Funds.--A State, political subdivision of a 
State, Indian tribe, tribal organization, or private nonprofit 
organization that receives a grant, contract, or cooperative 
agreement under subsection (a) shall use funds received under 
such grant--
            (1) to provide fully integrated services rather 
        than serial or parallel services;
            (2) to employ staff that are cross-trained in the 
        diagnosis and treatment of both serious mental illness 
        and substance abuse;
            (3) to provide integrated mental health and 
        substance abuse services at the same location;
            (4) to provide services that are linguistically 
        appropriate and culturally competent;
            (5) to provide at least 10 programs for integrated 
        treatment of both mental illness and substance abuse at 
        sites that previously provided only mental health 
        services or only substance abuse services; and
            (6) to provide services in coordination with other 
        existing public and private community programs.
    (d) Condition.--The Secretary shall ensure that a State, 
political subdivision of a State, Indian tribe, tribal 
organization, or private nonprofit organization that receives a 
grant, contract, or cooperative agreement under subsection (a) 
maintains the level of effort necessary to sustain existing 
mental health and substance abuse programs for other 
populations served by mental health systems in the community.
    (e) Distribution of Awards.--The Secretary shall ensure 
that grants, contracts, or cooperative agreements awarded under 
subsection (a) are equitably distributed among the geographical 
regions of the United States and between urban and rural 
populations.
    (f ) Duration.--The Secretary shall award grants, contract, 
or cooperative agreements under this subsection for a period of 
not more than 5 years.
    (g) Application.--A State, political subdivision of a 
State, Indian tribe, tribal organization, or private nonprofit 
organization that desires a grant, contract, or cooperative 
agreement under this subsection shall prepare and submit an 
application to the Secretary at such time, in such manner, and 
containing such information as the Secretary may require. Such 
application shall include a plan for the rigorous evaluation of 
activities funded with an award under such subsection, 
including a process and outcomes evaluation.
    (h) Evaluation.--A State, political subdivision of a State, 
Indian tribe, tribal organization, or private nonprofit 
organization that receives a grant, contract, or cooperative 
agreement under this subsection shall prepare and submit a plan 
for the rigorous evaluation of the program funded under such 
grant, contract, or agreement, including both process and 
outcomes evaluation, and the submission of an evaluation at the 
end of the project period.
    (i) Authorization of Appropriation.--There is authorized to 
be appropriated to carry out this subsection $40,000,000 for 
fiscal year 2001, and such sums as may be necessary for fiscal 
years 2002 through 2003.

SEC. 520J. [290BB-41] TRAINING GRANTS.

    (a) In General.--The Secretary shall award grants in 
accordance with the provisions of this section.
    (b) Mental Illness Awareness Training Grants.--
            (1) In general.--The Secretary shall award grants 
        to States, political subdivisions of States, Indian 
        tribes, tribal organizations, and nonprofit private 
        entities to train teachers and other relevant school 
        personnel to recognize symptoms of childhood and 
        adolescent mental disorders, to refer family members to 
        the appropriate mental health services if necessary, to 
        train emergency services personnel to identify and 
        appropriately respond to persons with a mental illness, 
        and to provide education to such teachers and personnel 
        regarding resources that are available in the community 
        for individuals with a mental illness.
            (2) Emergency Services Personnel \1\.--In this 
        subsection, the term ``emergency services personnel'' 
        includes paramedics, firefighters, and emergency 
        medical technicians.
---------------------------------------------------------------------------
    \1\So in law. Words in the heading (except the first) probably 
should be all small caps. See section 3213 of Public Law 106-310 (114 
Stat. 1206).
---------------------------------------------------------------------------
            (3) Distribution of Awards \1\.--The Secretary 
        shall ensure that such grants awarded under this 
        subsection are equitably distributed among the 
        geographical regions of the United States and between 
        urban and rural populations.
            (4) Application.--A State, political subdivision of 
        a State, Indian tribe, tribal organization, or 
        nonprofit private entity that desires a grant under 
        this subsection shall submit an application to the 
        Secretary at such time, in such manner, and containing 
        such information as the Secretary may require, 
        including a plan for the rigorous evaluation of 
        activities that are carried out with funds received 
        under a grant under this subsection.
            (5) Use of Funds.--A State, political subdivision 
        of a State, Indian tribe, tribal organization, or 
        nonprofit private entity receiving a grant under this 
        subsection shall use funds from such grant to--
                    (A) train teachers and other relevant 
                school personnel to recognize symptoms of 
                childhood and adolescent mental disorders and 
                appropriately respond;
                    (B) train emergency services personnel to 
                identify and appropriately respond to persons 
                with a mental illness; and
                    (C) provide education to such teachers and 
                personnel regarding resources that are 
                available in the community for individuals with 
                a mental illness.
            (6) Evaluation.--A State, political subdivision of 
        a State, Indian tribe, tribal organization, or 
        nonprofit private entity that receives a grant under 
        this subsection shall prepare and submit an evaluation 
        to the Secretary at such time, in such manner, and 
        containing such information as the Secretary may 
        reasonably require, including an evaluation of 
        activities carried out with funds received under the 
        grant under this subsection and a process and outcome 
        evaluation.
            (7) Authorization of Appropriations.--There is 
        authorized to be appropriated to carry out this 
        subsection, $25,000,000 for fiscal year 2001 and such 
        sums as may be necessary for each of fiscal years 2002 
        through 2003.

SEC. 520K. [290BB-42] AWARDS FOR CO-LOCATING PRIMARY AND SPECIALTY CARE 
                    IN COMMUNITY-BASED MENTAL HEALTH SETTINGS.

    (a) Definitions.--In this section:
            (1) Eligible entity.--The term ``eligible entity'' 
        means a qualified community mental health program 
        defined under section 1913(b)(1).
            (2) Special populations.--The term ``special 
        populations'' means adults with mental illnesses who 
        have co-occurring primary care conditions and chronic 
        diseases.
    (b) Program Authorized.--The Secretary, acting through the 
Administrator shall award grants and cooperative agreements to 
eligible entities to establish demonstration projects for the 
provision of coordinated and integrated services to special 
populations through the co-location of primary and specialty 
care services in community-based mental and behavioral health 
settings.
    (c) Application.--To be eligible to receive a grant or 
cooperative agreement under this section, an eligible entity 
shall submit an application to the Administrator at such time, 
in such manner, and accompanied by such information as the 
Administrator may require, including a description of 
partnerships, or other arrangements with local primary care 
providers, including community health centers, to provide 
services to special populations.
    (d) Use of Funds.--
            (1) In general.--For the benefit of special 
        populations, an eligible entity shall use funds awarded 
        under this section for--
                    (A) the provision, by qualified primary 
                care professionals, of on site primary care 
                services;
                    (B) reasonable costs associated with 
                medically necessary referrals to qualified 
                specialty care professionals, other 
                coordinators of care or, if permitted by the 
                terms of the grant or cooperative agreement, by 
                qualified specialty care professionals on a 
                reasonable cost basis on site at the eligible 
                entity;
                    (C) information technology required to 
                accommodate the clinical needs of primary and 
                specialty care professionals; or
                    (D) facility modifications needed to bring 
                primary and specialty care professionals on 
                site at the eligible entity.
            (2) Limitation.--Not to exceed 15 percent of grant 
        or cooperative agreement funds may be used for 
        activities described in subparagraphs (C) and (D) of 
        paragraph (1).
    (e) Evaluation.--Not later than 90 days after a grant or 
cooperative agreement awarded under this section expires, an 
eligible entity shall submit to the Secretary the results of an 
evaluation to be conducted by the entity concerning the 
effectiveness of the activities carried out under the grant or 
agreement.
    (f) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section, $50,000,000 for 
fiscal year 2010 and such sums as may be necessary for each of 
fiscal years 2011 through 2014.

    Part C--Projects for Assistance in Transition From Homelessness

SEC. 521. [290CC-21] FORMULA GRANTS TO STATES.

    For the purpose of carrying out section 522, the Secretary, 
acting through the Director of the Center for Mental Health 
Services, shall for each of the fiscal years 1991 through 1994 
\1\ make an allotment for each State in an amount determined in 
accordance with section 524. The Secretary shall make payments, 
as grants, each such fiscal year to each State from the 
allotment for the State if the Secretary approves for the 
fiscal year involved an application submitted by the State 
pursuant to section 529.
---------------------------------------------------------------------------
    \1\ Probably should be ``2001 through 2003''. Section 3203(b) of 
Public Law 106-310 (114 Stat. 1191) amended section 535(a) of this Act, 
which provides the authorization of appropriations for this part, by 
striking ``1991 through 1994'' and inserting ``2001 through 2003''. 
Such Public Law did not conform the reference in section 521 above.
---------------------------------------------------------------------------

SEC. 522. [290CC-22] PURPOSE OF GRANTS.

    (a) In General.--The Secretary may not make payments under 
section 521 unless the State involved agrees that the payments 
will be expended solely for making grants to political 
subdivisions of the State, and to nonprofit private entities 
(including community-based veterans organizations and other 
community organizations), for the purpose of providing the 
services specified in subsection (b) to individuals who--
            (1)(A) are suffering from serious mental illness; 
        or
            (B) are suffering from serious mental illness and 
        from substance abuse; and
            (2) are homeless or at imminent risk of becoming 
        homeless.
    (b) Specification of Services.--The services referred to in 
subsection (a) are--
            (1) outreach services;
            (2) screening and diagnostic treatment services;
            (3) habilitation and rehabilitation services;
            (4) community mental health services;
            (5) alcohol or drug treatment services;
            (6) staff training, including the training of 
        individuals who work in shelters, mental health 
        clinics, substance abuse programs, and other sites 
        where homeless individuals require services;
            (7) case management services, including--
                    (A) preparing a plan for the provision of 
                community mental health services to the 
                eligible homeless individual involved, and 
                reviewing such plan not less than once every 3 
                months;
                    (B) providing assistance in obtaining and 
                coordinating social and maintenance services 
                for the eligible homeless individuals, 
                including services relating to daily living 
                activities, personal financial planning, 
                transportation services, and habilitation and 
                rehabilitation services, prevocational and 
                vocational services, and housing services;
                    (C) providing assistance to the eligible 
                homeless individual in obtaining income support 
                services, including housing assistance, 
                supplemental nutrition assistance program 
                benefits, and supplemental security income 
                benefits;
                    (D) referring the eligible homeless 
                individual for such other services as may be 
                appropriate; and
                    (E) providing representative payee services 
                in accordance with section 1631(a)(2) of the 
                Social Security Act if the eligible homeless 
                individual is receiving aid under title XVI of 
                such act and if the applicant is designated by 
                the Secretary to provide such services;
            (8) supportive and supervisory services in 
        residential settings;
            (9) referrals for primary health services, job 
        training, educational services, and relevant housing 
        services;
            (10) subject to subsection (h)(1)--
                    (A) minor renovation, expansion, and repair 
                of housing;
                    (B) planning of housing;
                    (C) technical assistance in applying for 
                housing assistance;
                    (D) improving the coordination of housing 
                services;
                    (E) security deposits;
                    (F) the costs associated with matching 
                eligible homeless individuals with appropriate 
                housing situations; and
                    (G) 1-time rental payments to prevent 
                eviction; and
            (11) other appropriate services, as determined by 
        the Secretary.
    (c) Coordination.--The Secretary may not make payments 
under section 521 unless the State involved agrees to make 
grants pursuant to subsection (a) only to entities that have 
the capacity to provide, directly or through arrangements, the 
services specified in section 522(b), including coordinating 
the provision of services in order to meet the needs of 
eligible homeless individuals who are both mentally ill and 
suffering from substance abuse.
    (d) Special Consideration Regarding Veterans.--The 
Secretary may not make payments under section 521 unless the 
State involved agrees that, in making grants to entities 
pursuant to subsection (a), the State will give special 
consideration to entities with a demonstrated effectiveness in 
serving homeless veterans.
    (e) Special Rules.--The Secretary may not make payments 
under section 521 unless the State involved agrees that grants 
pursuant to subsection (a) will not be made to any entity 
that--
            (1) has a policy of excluding individuals from 
        mental health services due to the existence or 
        suspicion of substance abuse; or
            (2) has a policy of excluding individuals from 
        substance abuse services due to the existence or 
        suspicion of mental illness.
    (f) Administrative Expenses.--The Secretary may not make 
payments under section 521 unless the State involved agrees 
that not more than 4 percent of the payments will be expended 
for administrative expenses regarding the payments.
    (g) Maintenance of Effort.--The Secretary may not make 
payments under section 521 unless the State involved agrees 
that the State will maintain State expenditures for services 
specified in subsection (b) at a level that is not less than 
the average level of such expenditures maintained by the State 
for the 2-year period preceding the fiscal year for which the 
State is applying to receive such payments.
    (h) Restrictions on Use of Funds.--The Secretary may not 
make payments under section 521 unless the State involved 
agrees that--
            (1) not more than 20 percent of the payments will 
        be expended for housing services under subsection 
        (b)(10); and
            (2) the payments will not be expended--
                    (A) to support emergency shelters or 
                construction of housing facilities;
                    (B) for inpatient psychiatric treatment 
                costs or inpatient substance abuse treatment 
                costs; or
                    (C) to make cash payments to intended 
                recipients of mental health or substance abuse 
                services.
    (i) Waiver for Territories.--With respect to the United 
States Virgin Islands, Guam, American Samoa, Palau, the 
Marshall Islands, and the Commonwealth of the Northern Mariana 
Islands, the Secretary may waive the provisions of this part 
that the Secretary determines to be appropriate.

SEC. 523. [290CC-23] REQUIREMENT OF MATCHING FUNDS.

    (a) In General.--The Secretary may not make payments under 
section 521 unless, with respect to the costs of providing 
services pursuant to section 522, the State involved agrees to 
make available, directly or through donations from public or 
private entities, non-Federal contributions toward such costs 
in an amount that is not less than $1 for each $3 of Federal 
funds provided in such payments.
    (b) Determination of Amount.--Non-Federal contributions 
required in subsection (a) may be in cash or in kind, fairly 
evaluated, including plant, equipment, or services. Amounts 
provided by the Federal Government, or services assisted or 
subsidized to any significant extent by the Federal Government, 
shall not be included in determining the amount of such non-
Federal contributions.
    (c) Limitation Regarding Grants by States.--The Secretary 
may not make payments under section 521 unless the State 
involved agrees that the State will not require the entities to 
which grants are provided pursuant to section 522(a) to provide 
non-Federal contributions in excess of the non-Federal 
contributions described in subsection (a).

SEC. 524. [290CC-24] DETERMINATION OF AMOUNT OF ALLOTMENT.

    (a) Minimum Allotment.--The allotment for a State under 
section 521 for a fiscal year shall be the greater of--
            (1) $300,000 for each of the several States, the 
        District of Columbia, and the Commonwealth of Puerto 
        Rico, and $50,000 for each of Guam, the Virgin Islands, 
        American Samoa, and the Commonwealth of the Northern 
        Mariana Islands; and
            (2) an amount determined in accordance with 
        subsection (b).
    (b) Determination Under Formula.--The amount referred to in 
subsection (a)(2) is the product of--
            (1) an amount equal to the amount appropriated 
        under section 535(a) for the fiscal year; and
            (2) a percentage equal to the quotient of--
                    (A) an amount equal to the population 
                living in urbanized areas of the State 
                involved, as indicated by the most recent data 
                collected by the Bureau of the Census; and
                    (B) an amount equal to the population 
                living in urbanized areas of the United States, 
                as indicated by the sum of the respective 
                amounts determined for the States under 
                subparagraph (A).

SEC. 525. [290CC-25] CONVERSION TO CATEGORICAL PROGRAM IN EVENT OF 
                    FAILURE OF STATE REGARDING EXPENDITURE OF GRANTS.

    (a) In General.--Subject to subsection (c), the Secretary 
shall, from the amounts specified in subsection (b), make 
grants to public and nonprofit private entities for the purpose 
of providing to eligible homeless individuals the services 
specified in section 522(b).
    (b) \1\ Specification of Funds.--The amounts referred to in 
subsection (a) are any amounts made available in appropriations 
Acts for allotments under section 521 that are not paid to a 
State as a result of--
---------------------------------------------------------------------------
    \1\ So in law. Subparagraphs (A) through (C) probably should be 
redesignated as paragraphs (1) through (3), respectively. See section 
511 of Public Law 104-645 (104 Stat. 4729).
---------------------------------------------------------------------------
                    (A) the failure of the State to submit an 
                application under section 529;
                    (B) the failure of the State, in the 
                determination of the Secretary, to prepare the 
                application in accordance with such section or 
                to submit the application within a reasonable 
                period of time; or
                    (C) the State informing the Secretary that 
                the State does not intend to expend the full 
                amount of the allotment made to the State.
    (c) Requirement of Provision of Services in State 
Involved.--With respect to grants under subsection (a), amounts 
made available under subsection (b) as a result of the State 
involved shall be available only for grants to provide services 
in such State.

SEC. 526. [290CC-26] PROVISION OF CERTAIN INFORMATION FROM STATE.

    The Secretary may not make payments under section 521 to a 
State unless, as part of the application required in section 
529, the State submits to the Secretary a statement--
            (1) identifying existing programs providing 
        services and housing to eligible homeless individuals 
        and identify gaps in the delivery systems of such 
        programs;
            (2) containing a plan for providing services and 
        housing to eligible homeless individuals, which plan--
                    (A) describes the coordinated and 
                comprehensive means of providing services and 
                housing to homeless individuals; and
                    (B) includes documentation that suitable 
                housing for eligible homeless individuals will 
                accompany the provision of services to such 
                individuals;
            (3) describes the source of the non-Federal 
        contributions described in section 523;
            (4) contains assurances that the non-Federal 
        contributions described in section 523 will be 
        available at the beginning of the grant period;
            (5) describe any voucher system that may be used to 
        carry out this part; and
            (6) contain such other information or assurances as 
        the Secretary may reasonably require.

SEC. 527. [290CC-27] DESCRIPTION OF INTENDED EXPENDITURES OF GRANT.

    (a) In General.--The Secretary may not make payments under 
section 521 unless--
            (1) as part of the application required in section 
        529, the State involved submits to the Secretary a 
        description of the intended use for the fiscal year of 
        the amounts for which the State is applying pursuant to 
        such section;
            (2) such description identifies the geographic 
        areas within the State in which the greatest numbers of 
        homeless individuals with a need for mental health, 
        substance abuse, and housing services are located;
            (3) such description provides information relating 
        to the programs and activities to be supported and 
        services to be provided, including information relating 
        to coordinating such programs and activities with any 
        similar programs and activities of public and private 
        entities; and
            (4) the State agrees that such description will be 
        revised throughout the year as may be necessary to 
        reflect substantial changes in the programs and 
        activities assisted by the State pursuant to section 
        522.
    (b) Opportunity for Public Comment.--The Secretary may not 
make payments under section 521 unless the State involved 
agrees that, in developing and carrying out the description 
required in subsection (a), the State will provide public 
notice with respect to the description (including any 
revisions) and such opportunities as may be necessary to 
provide interested persons, such as family members, consumers, 
and mental health, substance abuse, and housing agencies, an 
opportunity to present comments and recommendations with 
respect to the description.
    (c) Relationship to State Comprehensive Mental Health 
Services Plan.--
            (1) In general.--The Secretary may not make 
        payments under section 521 unless the services to be 
        provided pursuant to the description required in 
        subsection (a) are consistent with the State 
        comprehensive mental health services plan required in 
        subpart 2 of part B of title XIX.
            (2) Special rule.--The Secretary may not make 
        payments under section 521 unless the services to be 
        provided pursuant to the description required in 
        subsection (a) have been considered in the preparation 
        of, have been included in, and are consistent with, the 
        State comprehensive mental health services plan 
        referred to in paragraph (1).

SEC. 528. [290CC-28] REQUIREMENT OF REPORTS BY STATES.

    (a) In General.--The Secretary may not make payments under 
section 521 unless the State involved agrees that, by not later 
than January 31 of each fiscal year, the State will prepare and 
submit to the Secretary a report in such form and containing 
such information as the Secretary determines (after 
consultation with the Administrator of the Substance Abuse and 
Mental Health Services Administration) to be necessary for--
            (1) securing a record and a description of the 
        purposes for which amounts received under section 521 
        were expended during the preceding fiscal year and of 
        the recipients of such amounts; and
            (2) determining whether such amounts were expended 
        in accordance with the provisions of this part.
    (b) Availability to Public of Reports.--The Secretary may 
not make payments under section 521 unless the State involved 
agrees to make copies of the reports described in subsection 
(a) available for public inspection.
    (c) Evaluations by Comptroller General.--The Administrator 
of the Substance Abuse and Mental Health Services 
Administration shall evaluate at least once every 3 years the 
expenditures of grants under this part by eligible entities in 
order to ensure that expenditures are consistent with the 
provisions of this part, and shall include in such evaluation 
recommendations regarding changes needed in program design or 
operations.

SEC. 529. [290CC-29] REQUIREMENT OF APPLICATION.

    The Secretary may not make payments under section 521 
unless the State involved--
            (1) submits to the Secretary an application for the 
        payments containing agreements and information in 
        accordance with this part;
            (2) the agreements are made through certification 
        from the chief executive officer of the State; and
            (3) the application otherwise is in such form, is 
        made in such manner, and contains such agreements, 
        assurances, and information as the Secretary determines 
        to be necessary to carry out this part.

SEC. 530. [290CC-30] TECHNICAL ASSISTANCE.

    The Secretary, through \1\ the National Institute of Mental 
Health, the National Institute of Alcohol Abuse and Alcoholism, 
and the National Institute on Drug Abuse, shall provide 
technical assistance to eligible entities in developing 
planning and operating programs in accordance with the 
provisions of this part.
---------------------------------------------------------------------------
    \1\ Section 162(2) of Public Law 102-321 (106 Stat. 375) provides 
that section 530 is amended by striking out ``through the National'' 
and all that follows through ``Abuse'' and inserting in lieu thereof 
``through the agencies of the Administration''. The amendment cannot be 
executed because it does not specify to which instance of the term 
``Abuse'' the amendment applies. Additionally, section 163(a)(3) of 
such law described an amendment that could not be executed, as the 
amendment included instructions to strike ``on Alcohol Abuse'' while 
``of Alcohol Abuse'' is the term in section 530. This latter amendment 
attempted to insert ``Administrator of the Substance Abuse and Mental 
Health Services Administration''. Subsequently, such section 163(a)(3) 
was struck by section 2(b)(2) of Public Law 102-352 (106 Stat. 939).
---------------------------------------------------------------------------

SEC. 531. [290CC-31] FAILURE TO COMPLY WITH AGREEMENTS.

    (a) Repayment of Payments.--
            (1) The Secretary may, subject to subsection (c), 
        require a State to repay any payments received by the 
        State under section 521 that the Secretary determines 
        were not expended by the State in accordance with the 
        agreements required to be contained in the application 
        submitted by the State pursuant to section 529.
            (2) If a State fails to make a repayment required 
        in paragraph (1), the Secretary may offset the amount 
        of the repayment against the amount of any payment due 
        to be paid to the State under section 521.
    (b) Withholding of Payments.--
            (1) The Secretary may, subject to subsection (c), 
        withhold payments due under section 521 if the 
        Secretary determines that the State involved is not 
        expending amounts received under such section in 
        accordance with the agreements required to be contained 
        in the application submitted by the State pursuant to 
        section 529.
            (2) The Secretary shall cease withholding payments 
        from a State under paragraph (1) if the Secretary 
        determines that there are reasonable assurances that 
        the State will expend amounts received under section 
        521 in accordance with the agreements referred to in 
        such paragraph.
            (3) The Secretary may not withhold funds under 
        paragraph (1) from a State for a minor failure to 
        comply with the agreements referred to in such 
        paragraph.
    (c) Opportunity for Hearing.--Before requiring repayment of 
payments under subsection (a)(1), or withholding payments under 
subsection (b)(1), the Secretary shall provide to the State an 
opportunity for a hearing.
    (d) Rule of Construction.--Notwithstanding any other 
provision of this part, a State receiving payments under 
section 521 may not, with respect to any agreements required to 
be contained in the application submitted under section 529, be 
considered to be in violation of any such agreements by reason 
of the fact that the State, in the regular course of providing 
services under section 522(b) to eligible homeless individuals, 
incidentally provides services to homeless individuals who are 
not eligible homeless individuals.

SEC. 532. [290CC-32] PROHIBITION AGAINST CERTAIN FALSE STATEMENTS.

    (a) In General.--
            (1) A person may not knowingly make or cause to be 
        made any false statement or representation of a 
        material fact in connection with the furnishing of 
        items or services for which amounts may be paid by a 
        State from payments received by the State under section 
        521.
            (2) A person with knowledge of the occurrence of 
        any event affecting the right of the person to receive 
        any amounts from payments made to the State under 
        section 521 may not conceal or fail to disclose any 
        such event with the intent of securing such an amount 
        that the person is not authorized to receive or 
        securing such an amount in an amount greater than the 
        amount the person is authorized to receive.
    (b) Criminal Penalty for Violation of Prohibition.--Any 
person who violates a prohibition established in subsection (a) 
may for each violation be fined in accordance with title 18, 
United States Code, or imprisoned for not more than 5 years, or 
both.

SEC. 533. [290CC-33] NONDISCRIMINATION.

    (a) In General.--
            (1) Rule of construction regarding certain civil 
        rights laws.--For the purpose of applying the 
        prohibitions against discrimination on the basis of age 
        under the Age Discrimination Act of 1975, on the basis 
        of handicap under section 504 of the Rehabilitation Act 
        of 1973, on the basis of sex under title IX of the 
        Education Amendments of 1972, or on the basis of race, 
        color, or national origin under title VI of the Civil 
        Rights Act of 1964, programs and activities funded in 
        whole or in part with funds made available under 
        section 521 shall be considered to be programs and 
        activities receiving Federal financial assistance.
            (2) Prohibition.--No person shall on the ground of 
        sex or religion be excluded from participation in, be 
        denied the benefits of, or be subjected to 
        discrimination under, any program or activity funded in 
        whole or in part with funds made available under 
        section 521.
    (b) Enforcement.--
            (1) Referrals to attorney general after notice.--
        Whenever the Secretary finds that a State, or an entity 
        that has received a payment pursuant to section 521, 
        has failed to comply with a provision of law referred 
        to in subsection (a)(1), with subsection (a)(2), or 
        with an applicable regulation (including one prescribed 
        to carry out subsection (a)(2)), the Secretary shall 
        notify the chief executive officer of the State and 
        shall request the chief executive officer to secure 
        compliance. If within a reasonable period of time, not 
        to exceed 60 days, the chief executive officer fails or 
        refuses to secure compliance, the Secretary may--
                    (A) refer the matter to the Attorney 
                General with a recommendation that an 
                appropriate civil action be instituted;
                    (B) exercise the powers and functions 
                provided by the Age Discrimination Act of 1975, 
                section 504 of the Rehabilitation Act of 1973, 
                title IX of the Education Amendments of 1972, 
                or title VI of the Civil Rights Act of 1964, as 
                may be applicable; or
                    (C) take such other actions as may be 
                authorized by law.
            (2) Authority of attorney general.--When a matter 
        is referred to the Attorney General pursuant to 
        paragraph (1)(A), or whenever the Attorney General has 
        reason to believe that a State or an entity is engaged 
        in a pattern or practice in violation of a provision of 
        law referred to in subsection (a)(1) or in violation of 
        subsection (a)(2), the Attorney General may bring a 
        civil action in any appropriate district court of the 
        United States for such relief as may be appropriate, 
        including injunctive relief.

SEC. 534. [290CC-34] DEFINITIONS.

    For purposes of this part:
            (1) Eligible homeless individual.--The term 
        ``eligible homeless individual'' means an individual 
        described in section 522(a).
            (2) Homeless individual.--The term ``homeless 
        individual'' has the meaning given such term in section 
        330(h)(5).
            (3) State.--The term ``State'' means each of the 
        several States, the District of Columbia, the 
        Commonwealth of Puerto Rico, the Virgin Islands, Guam, 
        American Samoa, and the Commonwealth of the Northern 
        Mariana Islands.
            (4) Substance abuse.--The term ``substance abuse'' 
        means the abuse of alcohol or other drugs.

SEC. 535. [290CC-35] FUNDING.

    (a) Authorization of Appropriations.--For the purpose of 
carrying out this part, there is authorized to be appropriated 
$75,000,000 for each of the fiscal years 2001 through 2003.
    (b) Effect of Insufficient Appropriations for Minimum 
Allotments.--
            (1) In general.--If the amounts made available 
        under subsection (a) for a fiscal year are insufficient 
        for providing each State with an allotment under 
        section 521 of not less than the applicable amount 
        under section 524(a)(1), the Secretary shall, from such 
        amounts as are made available under such subsection, 
        make grants to the States for providing to eligible 
        homeless individuals the services specified in section 
        522(b).
            (2) Rule of construction.--Paragraph (1) may not be 
        construed to require the Secretary to make a grant 
        under such paragraph to each State.

Part D--Miscellaneous Provisions Relating to Substance Abuse and Mental 
                                 Health

SEC. 541. [290DD] SUBSTANCE ABUSE AMONG GOVERNMENT AND OTHER EMPLOYEES.

    (a) Programs and Services.--
            (1) Development.--The Secretary, acting through the 
        Administrator of the Substance Abuse and Mental Health 
        Services Administration, shall be responsible for 
        fostering substance abuse prevention and treatment 
        programs and services in State and local governments 
        and in private industry.
            (2) Model programs.--
                    (A) In general.--Consistent with the 
                responsibilities described in paragraph (1), 
                the Secretary, acting through the Administrator 
                of the Substance Abuse and Mental Health 
                Services Administration, shall develop a 
                variety of model programs suitable for 
                replication on a cost-effective basis in 
                different types of business concerns and State 
                and local governmental entities.
                    (B) Dissemination of information.--The 
                Secretary, acting through the Administrator of 
                the Substance Abuse and Mental Health Services 
                Administration, shall disseminate information 
                and materials relative to such model programs 
                to the State agencies responsible for the 
                administration of substance abuse prevention, 
                treatment, and rehabilitation activities and 
                shall, to the extent feasible provide technical 
                assistance to such agencies as requested.
    (b) Deprivation of Employment.--
            (1) Prohibition.--No person may be denied or 
        deprived of Federal civilian employment or a Federal 
        professional or other license or right solely on the 
        grounds of prior substance abuse.
            (2) Application.--This subsection shall not apply 
        to employment in--
                    (A) the Central Intelligence Agency;
                    (B) the Federal Bureau of Investigation;
                    (C) the National Security Agency;
                    (D) any other department or agency of the 
                Federal Government designated for purposes of 
                national security by the President; or
                    (E) in any position in any department or 
                agency of the Federal Government, not referred 
                to in subparagraphs (A) through (D), which 
                position is determined pursuant to regulations 
                prescribed by the head of such agency or 
                department to be a sensitive position.
            (3) Rehabilitation Act.--The inapplicability of the 
        prohibition described in paragraph (1) to the 
        employment described in paragraph (2) shall not be 
        construed to reflect on the applicability of the 
        Rehabilitation Act of 1973 or other anti-discrimination 
        laws to such employment.
    (c) Construction.--This section shall not be construed to 
prohibit the dismissal from employment of a Federal civilian 
employee who cannot properly function in his employment.

SEC. 542. [290DD-1] ADMISSION OF SUBSTANCE ABUSERS TO PRIVATE AND 
                    PUBLIC HOSPITALS AND OUTPATIENT FACILITIES.

    (a) Nondiscrimination.--Substance abusers who are suffering 
from medical conditions shall not be discriminated against in 
admission or treatment, solely because of their substance 
abuse, by any private or public general hospital, or outpatient 
facility (as defined in section 1624(4)) which receives support 
in any form from any program supported in whole or in part by 
funds appropriated to any Federal department or agency.
    (b) Regulations.--
            (1) In general.--The Secretary shall issue 
        regulations for the enforcement of the policy of 
        subsection (a) with respect to the admission and 
        treatment of substance abusers in hospitals and 
        outpatient facilities which receive support of any kind 
        from any program administered by the Secretary. Such 
        regulations shall include procedures for determining 
        (after opportunity for a hearing if requested) if a 
        violation of subsection (a) has occurred, notification 
        of failure to comply with such subsection, and 
        opportunity for a violator to comply with such 
        subsection. If the Secretary determines that a hospital 
        or outpatient facility subject to such regulations has 
        violated subsection (a) and such violation continues 
        after an opportunity has been afforded for compliance, 
        the Secretary may suspend or revoke, after opportunity 
        for a hearing, all or part of any support of any kind 
        received by such hospital from any program administered 
        by the Secretary. The Secretary may consult with the 
        officials responsible for the administration of any 
        other Federal program from which such hospital or 
        outpatient facility receives support of any kind, with 
        respect to the suspension or revocation of such other 
        Federal support for such hospital or outpatient 
        facility.
            (2) Department of veterans affairs.--The Secretary 
        of Veterans Affairs, acting through the Under Secretary 
        for Health, shall, to the maximum feasible extent 
        consistent with their responsibilities under title 38, 
        United States Code, prescribe regulations making 
        applicable the regulations prescribed by the Secretary 
        under paragraph (1) to the provision of hospital care, 
        nursing home care, domiciliary care, and medical 
        services under such title 38 to veterans suffering from 
        substance abuse. In prescribing and implementing 
        regulations pursuant to this paragraph, the Secretary 
        shall, from time to time, consult with the Secretary of 
        Health and Human Services in order to achieve the 
        maximum possible coordination of the regulations, and 
        the implementation thereof, which they each prescribe.

SEC. 543. [290DD-2] CONFIDENTIALITY OF RECORDS.

    (a) Requirement.--Records of the identity, diagnosis, 
prognosis, or treatment of any patient which are maintained in 
connection with the performance of any program or activity 
relating to substance abuse education, prevention, training, 
treatment, rehabilitation, or research, which is conducted, 
regulated, or directly or indirectly assisted by any department 
or agency of the United States shall, except as provided in 
subsection (e), be confidential and be disclosed only for the 
purposes and under the circumstances expressly authorized under 
subsection (b).
    (b) Permitted Disclosure.--
            (1) Consent.--The content of any record referred to 
        in subsection (a) may be disclosed in accordance with 
        the prior written consent of the patient with respect 
        to whom such record is maintained, but only to such 
        extent, under such circumstances, and for such purposes 
        as may be allowed under regulations prescribed pursuant 
        to subsection (g).
            (2) Method for disclosure.--Whether or not the 
        patient, with respect to whom any given record referred 
        to in subsection (a) is maintained, gives written 
        consent, the content of such record may be disclosed as 
        follows:
                    (A) To medical personnel to the extent 
                necessary to meet a bona fide medical 
                emergency.
                    (B) To qualified personnel for the purpose 
                of conducting scientific research, management 
                audits, financial audits, or program 
                evaluation, but such personnel may not 
                identify, directly or indirectly, any 
                individual patient in any report of such 
                research, audit, or evaluation, or otherwise 
                disclose patient identities in any manner.
                    (C) If authorized by an appropriate order 
                of a court of competent jurisdiction granted 
                after application showing good cause therefor, 
                including the need to avert a substantial risk 
                of death or serious bodily harm. In assessing 
                good cause the court shall weigh the public 
                interest and the need for disclosure against 
                the injury to the patient, to the physician-
                patient relationship, and to the treatment 
                services. Upon the granting of such order, the 
                court, in determining the extent to which any 
                disclosure of all or any part of any record is 
                necessary, shall impose appropriate safeguards 
                against unauthorized disclosure.
    (c) Use of Records in Criminal Proceedings.--Except as 
authorized by a court order granted under subsection (b)(2)(C), 
no record referred to in subsection (a) may be used to initiate 
or substantiate any criminal charges against a patient or to 
conduct any investigation of a patient.
    (d) Application.--The prohibitions of this section continue 
to apply to records concerning any individual who has been a 
patient, irrespective of whether or when such individual ceases 
to be a patient.
    (e) Nonapplicability.--The prohibitions of this section do 
not apply to any interchange of records--
            (1) within the Uniformed Services or within those 
        components of the Department of Veterans Affairs 
        furnishing health care to veterans; or
            (2) between such components and the Uniformed 
        Services.

The prohibitions of this section do not apply to the reporting 
under State law of incidents of suspected child abuse and 
neglect to the appropriate State or local authorities.
    (f) Penalties.--Any person who violates any provision of 
this section or any regulation issued pursuant to this section 
shall be fined in accordance with title 18, United States Code.
    (g) Regulations.--Except as provided in subsection (h), the 
Secretary shall prescribe regulations to carry out the purposes 
of this section. Such regulations may contain such definitions, 
and may provide for such safeguards and procedures, including 
procedures and criteria for the issuance and scope of orders 
under subsection (b)(2)(C), as in the judgment of the Secretary 
are necessary or proper to effectuate the purposes of this 
section, to prevent circumvention or evasion thereof, or to 
facilitate compliance therewith.
    (h) Application to Department of Veterans Affairs.--The 
Secretary of Veterans Affairs, acting through the Chief Medical 
Director, shall, to the maximum feasible extent consistent with 
their responsibilities under title 38, United States Code, 
prescribe regulations making applicable the regulations 
prescribed by the Secretary of Health and Human Services under 
subsection (g) of this section to records maintained in 
connection with the provision of hospital care, nursing home 
care, domiciliary care, and medical services under such title 
38 to veterans suffering from substance abuse. In prescribing 
and implementing regulations pursuant to this subsection, the 
Secretary of Veterans Affairs shall, from time to time, consult 
with the Secretary of Health and Human Services in order to 
achieve the maximum possible coordination of the regulations, 
and the implementation thereof, which they each prescribe.

          Part E--Children With Serious Emotional Disturbances

 H4  deg.SEC. 561. [290FF] COMPREHENSIVE COMMUNITY MENTAL 
                    HEALTH SERVICES FOR CHILDREN WITH SERIOUS EMOTIONAL 
                    DISTURBANCES.

    (a) Grants to Certain Public Entities.--
            (1) In general.--The Secretary, acting through the 
        Director of the Center for Mental Health Services, 
        shall make grants to public entities for the purpose of 
        providing comprehensive community mental health 
        services to children with a serious emotional 
        disturbance.
            (2) Definition of public entity.--For purposes of 
        this part, the term ``public entity'' means any State, 
        any political subdivision of a State, and any Indian 
        tribe or tribal organization (as defined in section 
        4(b) and section 4(c) of the Indian Self-Determination 
        and Education Assistance Act).
    (b) Considerations in Making Grants.--
            (1) Requirement of status as grantee under part b 
        of title xix.--The Secretary may make a grant under 
        subsection (a) to a public entity only if--
                    (A) in the case of a public entity that is 
                a State, the State is such a grantee under 
                section 1911;
                    (B) in the case of a public entity that is 
                a political subdivision of a State, the State 
                in which the political subdivision is located 
                is such a grantee; and
                    (C) in the case of a public entity that is 
                an Indian tribe or tribal organization, the 
                State in which the tribe or tribal organization 
                is located is such a grantee.
            (2) Requirement of status as medicaid provider.--
                    (A) Subject to subparagraph (B), the 
                Secretary may make a grant under subsection (a) 
                only if, in the case of any service under such 
                subsection that is covered in the State plan 
                approved under title XIX of the Social Security 
                Act for the State involved--
                            (i) the public entity involved will 
                        provide the service directly, and the 
                        entity has entered into a participation 
                        agreement under the State plan and is 
                        qualified to receive payments under 
                        such plan; or
                            (ii) the public entity will enter 
                        into an agreement with an organization 
                        under which the organization will 
                        provide the service, and the 
                        organization has entered into such a 
                        participation agreement and is 
                        qualified to receive such payments.
                    (B)(i) In the case of an organization 
                making an agreement under subparagraph (A)(ii) 
                regarding the provision of services under 
                subsection (a), the requirement established in 
                such subparagraph regarding a participation 
                agreement shall be waived by the Secretary if 
                the organization does not, in providing health 
                or mental health services, impose a charge or 
                accept reimbursement available from any third-
                party payor, including reimbursement under any 
                insurance policy or under any Federal or State 
                health benefits program.
                    (ii) A determination by the Secretary of 
                whether an organization referred to in clause 
                (i) meets the criteria for a waiver under such 
                clause shall be made without regard to whether 
                the organization accepts voluntary donations 
                regarding the provision of services to the 
                public.
            (3) Certain considerations.--In making grants under 
        subsection (a), the Secretary shall--
                    (A) equitably allocate such assistance 
                among the principal geographic regions of the 
                United States;
                    (B) consider the extent to which the public 
                entity involved has a need for the grant; and
                    (C) in the case of any public entity that 
                is a political subdivision of a State or that 
                is an Indian tribe or tribal organization--
                            (i) shall consider any comments 
                        regarding the application of the entity 
                        for such a grant that are received by 
                        the Secretary from the State in which 
                        the entity is located; and
                            (ii) shall give special 
                        consideration to the entity if the 
                        State agrees to provide a portion of 
                        the non-Federal contributions required 
                        in subsection (c) regarding such a 
                        grant.
    (c) Matching Funds.--
            (1) In general.--A funding agreement for a grant 
        under subsection (a) is that the public entity involved 
        will, with respect to the costs to be incurred by the 
        entity in carrying out the purpose described in such 
        subsection, make available (directly or through 
        donations from public or private entities) non-Federal 
        contributions toward such costs in an amount that--
                    (A) for the first fiscal year for which the 
                entity receives payments from a grant under 
                such subsection, is not less than $1 for each 
                $3 of Federal funds provided in the grant;
                    (B) for any second or third such fiscal 
                year, is not less than $1 for each $3 of 
                Federal funds provided in the grant;
                    (C) for any fourth such fiscal year, is not 
                less than $1 for each $1 of Federal funds 
                provided in the grant; and
                    (D) for any fifth and sixth such fiscal 
                year, is not less than $2 for each $1 of 
                Federal funds provided in the grant.
            (2) Determination of amount contributed.--
                    (A) Non-Federal contributions required in 
                paragraph (1) may be in cash or in kind, fairly 
                evaluated, including plant, equipment, or 
                services. Amounts provided by the Federal 
                Government, or services assisted or subsidized 
                to any significant extent by the Federal 
                Government, may not be included in determining 
                the amount of such non-Federal contributions.
                    (B) In making a determination of the amount 
                of non-Federal contributions for purposes of 
                subparagraph (A), the Secretary may include 
                only non-Federal contributions in excess of the 
                average amount of non-Federal contributions 
                made by the public entity involved toward the 
                purpose described in subsection (a) for the 2-
                year period preceding the first fiscal year for 
                which the entity receives a grant under such 
                section.

 H4  deg.SEC. 562. [290FF-1] REQUIREMENTS WITH RESPECT TO 
                    CARRYING OUT PURPOSE OF GRANTS.

    (a) Systems of Comprehensive Care.--
            (1) In general.--A funding agreement for a grant 
        under section 561(a) is that, with respect to children 
        with a serious emotional disturbance, the public entity 
        involved will carry out the purpose described in such 
        section only through establishing and operating 1 or 
        more systems of care for making each of the mental 
        health services specified in subsection (c) available 
        to each child provided access to the system. In 
        providing for such a system, the public entity may make 
        grants to, and enter into contracts with, public and 
        nonprofit private entities.
            (2) Structure of system.--A funding agreement for a 
        grant under section 561(a) is that a system of care 
        under paragraph (1) will--
                    (A) be established in a community selected 
                by the public entity involved;
                    (B) consist of such public agencies and 
                nonprofit private entities in the community as 
                are necessary to ensure that each of the 
                services specified in subsection (c) is 
                available to each child provided access to the 
                system;
                    (C) be established pursuant to agreements 
                that the public entity enters into with the 
                agencies and entities described in subparagraph 
                (B);
                    (D) coordinate the provision of the 
                services of the system; and
                    (E) establish an office whose functions are 
                to serve as the location through which children 
                are provided access to the system, to 
                coordinate the provision of services of the 
                system, and to provide information to the 
                public regarding the system.
            (3) Collaboration of local public entities.--A 
        funding agreement for a grant under section 561(a) is 
        that, for purposes of the establishment and operation 
        of a system of care under paragraph (1), the public 
        entity involved will seek collaboration among all 
        public agencies that provide human services in the 
        community in which the system is established, including 
        but not limited to those providing mental health 
        services, educational services, child welfare services, 
        or juvenile justice services.
    (b) Limitation on Age of Children Provided Access to 
System.--A funding agreement for a grant under section 561(a) 
is that a system of care under subsection (a) will not provide 
an individual with access to the system if the individual is 
more than 21 years of age.
    (c) Required Mental Health Services of System.--A funding 
agreement for a grant under section 561(a) is that mental 
health services provided by a system of care under subsection 
(a) will include, with respect to a serious emotional 
disturbance in a child--
            (1) diagnostic and evaluation services;
            (2) outpatient services provided in a clinic, 
        office, school or other appropriate location, including 
        individual, group and family counseling services, 
        professional consultation, and review and management of 
        medications;
            (3) emergency services, available 24-hours a day, 7 
        days a week;
            (4) intensive home-based services for children and 
        their families when the child is at imminent risk of 
        out-of-home placement;
            (5) intensive day-treatment services;
            (6) respite care;
            (7) therapeutic foster care services, and services 
        in therapeutic foster family homes or individual 
        therapeutic residential homes, and groups homes caring 
        for not more than 10 children; and
            (8) assisting the child in making the transition 
        from the services received as a child to the services 
        to be received as an adult.
    (d) Required Arrangements Regarding Other Appropriate 
Services.--
            (1) In general.--A funding agreement for a grant 
        under section 561(a) is that--
                    (A) a system of care under subsection (a) 
                will enter into a memorandum of understanding 
                with each of the providers specified in 
                paragraph (2) in order to facilitate the 
                availability of the services of the provider 
                involved to each child provided access to the 
                system; and
                    (B) the grant under such section 561(a), 
                and the non-Federal contributions made with 
                respect to the grant, will not be expended to 
                pay the costs of providing such non-mental 
                health services to any individual.
            (2) Specification of non-mental health services.--
        The providers referred to in paragraph (1) are 
        providers of medical services other than mental health 
        services, providers of educational services, providers 
        of vocational counseling and vocational rehabilitation 
        services, and providers of protection and advocacy 
        services with respect to mental health.
            (3) Facilitation of services of certain programs.--
        A funding agreement for a grant under section 561(a) is 
        that a system of care under subsection (a) will, for 
        purposes of paragraph (1), enter into a memorandum of 
        understanding regarding facilitation of--
                    (A) services available pursuant to title 
                XIX of the Social Security Act, including 
                services regarding early periodic screening, 
                diagnosis, and treatment;
                    (B) services available under parts B and C 
                of the Individuals with Disabilities Education 
                Act; and
                    (C) services available under other 
                appropriate programs, as identified by the 
                Secretary.
    (e) General Provisions Regarding Services of System.--
            (1) Case management services.--A funding agreement 
        for a grant under section 561(a) is that a system of 
        care under subsection (a) will provide for the case 
        management of each child provided access to the system 
        in order to ensure that--
                    (A) the services provided through the 
                system to the child are coordinated and that 
                the need of each such child for the services is 
                periodically reassessed;
                    (B) information is provided to the family 
                of the child on the extent of progress being 
                made toward the objectives established for the 
                child under the plan of services implemented 
                for the child pursuant to section 563; and
                    (C) the system provides assistance with 
                respect to--
                            (i) establishing the eligibility of 
                        the child, and the family of the child, 
                        for financial assistance and services 
                        under Federal, State, or local programs 
                        providing for health services, mental 
                        health services, educational services, 
                        social services, or other services; and
                            (ii) seeking to ensure that the 
                        child receives appropriate services 
                        available under such programs.
            (2) Other provisions.--A funding agreement for a 
        grant under section 561(a) is that a system of care 
        under subsection (a), in providing the services of the 
        system, will--
                    (A) provide the services of the system in 
                the cultural context that is most appropriate 
                for the child and family involved;
                    (B) ensure that individuals providing such 
                services to the child can effectively 
                communicate with the child and family in the 
                most direct manner;
                    (C) provide the services without 
                discriminating against the child or the family 
                of the child on the basis of race, religion, 
                national origin, sex, disability, or age;
                    (D) seek to ensure that each child provided 
                access to the system of care remains in the 
                least restrictive, most normative environment 
                that is clinically appropriate; and
                    (E) provide outreach services to inform 
                individuals, as appropriate, of the services 
                available from the system, including 
                identifying children with a serious emotional 
                disturbance who are in the early stages of such 
                disturbance.
            (3) Rule of construction.--An agreement made under 
        paragraph (2) may not be construed--
                    (A) with respect to subparagraph (C) of 
                such paragraph--
                            (i) to prohibit a system of care 
                        under subsection (a) from requiring 
                        that, in housing provided by the 
                        grantee for purposes of residential 
                        treatment services authorized under 
                        subsection (c), males and females be 
                        segregated to the extent appropriate in 
                        the treatment of the children involved; 
                        or
                            (ii) to prohibit the system of care 
                        from complying with the agreement made 
                        under subsection (b); or
                    (B) with respect to subparagraph (D) of 
                such paragraph, to authorize the system of care 
                to expend the grant under section 561(a) (or 
                the non-Federal contributions made with respect 
                to the grant) to provide legal services or any 
                service with respect to which expenditures 
                regarding the grant are prohibited under 
                subsection (d)(1)(B).
    (f) Restrictions on Use of Grant.--A funding agreement for 
a grant under section 561(a) is that the grant, and the non-
Federal contributions made with respect to the grant, will not 
be expended--
            (1) to purchase or improve real property (including 
        the construction or renovation of facilities);
            (2) to provide for room and board in residential 
        programs serving 10 or fewer children;
            (3) to provide for room and board or other services 
        or expenditures associated with care of children in 
        residential treatment centers serving more than 10 
        children or in inpatient hospital settings, except 
        intensive home-based services and other services 
        provided on an ambulatory or outpatient basis; or
            (4) to provide for the training of any individual, 
        except training authorized in section 564(a)(2) and 
        training provided through any appropriate course in 
        continuing education whose duration does not exceed 2 
        days.
    (g) Waivers.--The Secretary may waive one or more of the 
requirements of subsection (c) for a public entity that is an 
Indian Tribe or tribal organization, or American Samoa, Guam, 
the Marshall Islands, the Federated States of Micronesia, the 
Commonwealth of the Northern Mariana Islands, the Republic of 
Palau, or the United States Virgin Islands if the Secretary 
determines, after peer review, that the system of care is 
family-centered and uses the least restrictive environment that 
is clinically appropriate.

 H4  deg.SEC. 563. [290FF-2] INDIVIDUALIZED PLAN FOR SERVICES.

    (a) In General.--A funding agreement for a grant under 
section 561(a) is that a system of care under section 562(a) 
will develop and carry out an individualized plan of services 
for each child provided access to the system, and that the plan 
will be developed and carried out with the participation of the 
family of the child and, unless clinically inappropriate, with 
the participation of the child.
    (b) Multidisciplinary Team.--A funding agreement for a 
grant under section 561(a) is that the plan required in 
subsection (a) will be developed, and reviewed and as 
appropriate revised not less than once each year, by a 
multidisciplinary team of appropriately qualified individuals 
who provide services through the system, including as 
appropriate mental health services, other health services, 
educational services, social services, and vocational 
counseling and rehabilitation; \1\
---------------------------------------------------------------------------
    \1\ So in law. See section 119 of Public Law 102-321 (106 Stat. 
349). Probably should be a period.
---------------------------------------------------------------------------
    (c) Coordination With Services Under Individuals with 
Disabilities Education Act.--A funding agreement for a grant 
under section 561(a) is that, with respect to a plan under 
subsection (a) for a child, the multidisciplinary team required 
in subsection (b) will--
            (1) in developing, carrying out, reviewing, and 
        revising the plan consider any individualized education 
        program in effect for the child pursuant to part B of 
        the Individuals with Disabilities Education Act;
            (2) ensure that the plan is consistent with such 
        individualized education program and provides for 
        coordinating services under the plan with services 
        under such program; and
            (3) ensure that the memorandum of understanding 
        entered into under section 562(d)(3)(B) regarding such 
        Act includes provisions regarding compliance with this 
        subsection.
    (d) Contents of Plan.--A funding agreement for a grant 
under section 561(a) is that the plan required in subsection 
(a) for a child will--
            (1) identify and state the needs of the child for 
        the services available pursuant to section 562 through 
        the system;
            (2) provide for each of such services that is 
        appropriate to the circumstances of the child, 
        including, except in the case of children who are less 
        than 14 years of age, the provision of appropriate 
        vocational counseling and rehabilitation, and 
        transition services (as defined in section 602 of the 
        Individuals with Disabilities Education Act);
            (3) establish objectives to be achieved regarding 
        the needs of the child and the methodology for 
        achieving the objectives; and
            (4) designate an individual to be responsible for 
        providing the case management required in section 
        562(e)(1) or certify that case management services will 
        be provided to the child as part of the individualized 
        education program of the child under the Individuals 
        with Disabilities Education Act.

 H4  deg.SEC. 564. [290FF-3] ADDITIONAL PROVISIONS.

    (a) Optional Services.--In addition to services described 
in subsection (c) of section 562, a system of care under 
subsection (a) of such section may, in expending a grant under 
section 561(a), provide for--
            (1) preliminary assessments to determine whether a 
        child should be provided access to the system;
            (2) training in--
                    (A) the administration of the system;
                    (B) the provision of intensive home-based 
                services under paragraph (4) of section 562(c), 
                intensive day treatment under paragraph (5) of 
                such section, and foster care or group homes 
                under paragraph (7) of such section; and
                    (C) the development of individualized plans 
                for purposes of section 563;
            (3) recreational activities for children provided 
        access to the system; and
            (4) such other services as may be appropriate in 
        providing for the comprehensive needs with respect to 
        mental health of children with a serious emotional 
        disturbance.
    (b) Comprehensive Plan.--The Secretary may make a grant 
under section 561(a) only if, with respect to the jurisdiction 
of the public entity involved, the entity has submitted to the 
Secretary, and has had approved by the Secretary, a plan for 
the development of a jurisdiction-wide system of care for 
community-based services for children with a serious emotional 
disturbance that specifies the progress the public entity has 
made in developing the jurisdiction-wide system, the extent of 
cooperation across agencies serving children in the 
establishment of the system, the Federal and non-Federal 
resources currently committed to the establishment of the 
system, and the current gaps in community services and the 
manner in which the grant under section 561(a) will be expended 
to address such gaps and establish local systems of care.
    (c) Limitation on Imposition of Fees for Services.--A 
funding agreement for a grant under section 561(a) is that, if 
a charge is imposed for the provision of services under the 
grant, such charge--
            (1) will be made according to a schedule of charges 
        that is made available to the public;
            (2) will be adjusted to reflect the income of the 
        family of the child involved; and
            (3) will not be imposed on any child whose family 
        has income and resources of equal to or less than 100 
        percent of the official poverty line, as established by 
        the Director of the Office of Management and Budget and 
        revised by the Secretary in accordance with section 
        673(2) of the Omnibus Budget Reconciliation Act of 
        1981.
    (d) Relationship to Items and Services Under Other 
Programs.--A funding agreement for a grant under section 561(a) 
is that the grant, and the non-Federal contributions made with 
respect to the grant, will not be expended to make payment for 
any item or service to the extent that payment has been made, 
or can reasonably be expected to be made, with respect to such 
item or service--
            (1) under any State compensation program, under an 
        insurance policy, or under any Federal or State health 
        benefits program; or
            (2) by an entity that provides health services on a 
        prepaid basis.
    (e) Limitation on Administrative Expenses.--A funding 
agreement for a grant under section 561(a) is that not more 
than 2 percent of the grant will be expended for administrative 
expenses incurred with respect to the grant by the public 
entity involved.
    (f) Reports to Secretary.--A funding agreement for a grant 
under section 561(a) is that the public entity involved will 
annually submit to the Secretary a report on the activities of 
the entity under the grant that includes a description of the 
number of children provided access to systems of care operated 
pursuant to the grant, the demographic characteristics of the 
children, the types and costs of services provided pursuant to 
the grant, the availability and use of third-party 
reimbursements, estimates of the unmet need for such services 
in the jurisdiction of the entity, and the manner in which the 
grant has been expended toward the establishment of a 
jurisdiction-wide system of care for children with a serious 
emotional disturbance, and such other information as the 
Secretary may require with respect to the grant.
    (g) Description of Intended Uses of Grant.--The Secretary 
may make a grant under section 561(a) only if--
            (1) the public entity involved submits to the 
        Secretary a description of the purposes for which the 
        entity intends to expend the grant;
            (2) the description identifies the populations, 
        areas, and localities in the jurisdiction of the entity 
        with a need for services under this section; and
            (3) the description provides information relating 
        to the services and activities to be provided, 
        including a description of the manner in which the 
        services and activities will be coordinated with any 
        similar services or activities of public or nonprofit 
        entities.
    (h) Requirement of Application.--The Secretary may make a 
grant under section 561(a) only if an application for the grant 
is submitted to the Secretary, the application contains the 
description of intended uses required in subsection (g), and 
the application is in such form, is made in such manner, and 
contains such agreements, assurances, and information as the 
Secretary determines to be necessary to carry out this section.

 H4  deg.SEC. 565. [290FF-4] GENERAL PROVISIONS.

    (a) Duration of Support.--The period during which payments 
are made to a public entity from a grant under section 561(a) 
may not exceed 6 fiscal years.
    (b) Technical Assistance.--
            (1) In general.--The Secretary shall, upon the 
        request of a public entity receiving a grant under 
        section 561(a)--
                    (A) provide technical assistance to the 
                entity regarding the process of submitting to 
                the Secretary applications for grants under 
                section 561(a); and
                    (B) provide to the entity training and 
                technical assistance with respect to the 
                planning, development, and operation of systems 
                of care pursuant to section 562.
            (2) Authority for grants and contracts.--The 
        Secretary may provide technical assistance under 
        subsection (a) directly or through grants to, or 
        contracts with, public and nonprofit private entities.
    (c) Evaluations and Reports by Secretary.--
            (1) In general.--The Secretary shall, directly or 
        through contracts with public or private entities, 
        provide for annual evaluations of programs carried out 
        pursuant to section 561(a). The evaluations shall 
        assess the effectiveness of the systems of care 
        operated pursuant to such section, including 
        longitudinal studies of outcomes of services provided 
        by such systems, other studies regarding such outcomes, 
        the effect of activities under this part on the 
        utilization of hospital and other institutional 
        settings, the barriers to and achievements resulting 
        from interagency collaboration in providing community-
        based services to children with a serious emotional 
        disturbance, and assessments by parents of the 
        effectiveness of the systems of care.
            (2) Report to congress.--The Secretary shall, not 
        later than 1 year after the date on which amounts are 
        first appropriated under subsection (c), and annually 
        thereafter, submit to the Congress a report summarizing 
        evaluations carried out pursuant to paragraph (1) 
        during the preceding fiscal year and making such 
        recommendations for administrative and legislative 
        initiatives with respect to this section as the 
        Secretary determines to be appropriate.
    (d) Definitions.--For purposes of this part:
            (1) The term ``child'' means an individual not more 
        than 21 years of age.
            (2) The term ``family'', with respect to a child 
        provided access to a system of care under section 
        562(a), means--
                    (A) the legal guardian of the child; and
                    (B) as appropriate regarding mental health 
                services for the child, the parents of the 
                child (biological or adoptive, as the case may 
                be) and any foster parents of the child.
            (3) The term ``funding agreement'', with respect to 
        a grant under section 561(a) to a public entity, means 
        that the Secretary may make such a grant only if the 
        public entity makes the agreement involved.
            (4) The term ``serious emotional disturbance'' 
        includes, with respect to a child, any child who has a 
        serious emotional disorder, a serious behavioral 
        disorder, or a serious mental disorder.
    (e) Rule of Construction.--Nothing in this part shall be 
construed as limiting the rights of a child with a serious 
emotional disturbance under the Individuals with Disabilities 
Education Act.
    (f) Funding.--
            (1) Authorization of appropriations.--For the 
        purpose of carrying out this part, there are authorized 
        to be appropriated $100,000,000 for fiscal year 2001, 
        and such sums as may be necessary for each of the 
        fiscal years 2002 and 2003.
    (2) \1\ Limitation regarding technical assistance.--Not 
more than 10 percent of the amounts appropriated under 
paragraph (1) for a fiscal year may be expended for carrying 
out subsection (b).
---------------------------------------------------------------------------
    \1\ Indentation is so in law. See section 2017(2)(C)(ii) of Public 
Law 103-43 (107 Stat. 218).
---------------------------------------------------------------------------

 Part F--Model Comprehensive Program for Treatment of Substance Abuse 
                                  \2\

    
---------------------------------------------------------------------------
    \2\ The part designation and heading for part F are so in law. Part 
F formerly consisted of section 571. That section was repealed by 
section 3301(c)(4) of Public Law 106-310 (114 Stat. 1209), but there 
was no conforming amendment to strike the designation and heading for 
part F.
---------------------------------------------------------------------------

             Part G \3\--Projects for Children and Violence

SEC. 581. \3\ [290HH] CHILDREN AND VIOLENCE.
---------------------------------------------------------------------------

    \3\ There is another part G in this title, which also begins with a 
section 581. See page 677. That part G relates to services provided 
through religious organizations.
---------------------------------------------------------------------------
    (a) In General.--The Secretary, in consultation with the 
Secretary of Education and the Attorney General, shall carry 
out directly or through grants, contracts or cooperative 
agreements with public entities a program to assist local 
communities in developing ways to assist children in dealing 
with violence.
    (b) Activities.--Under the program under subsection (a), 
the Secretary may--
            (1) provide financial support to enable local 
        communities to implement programs to foster the health 
        and development of children;
            (2) provide technical assistance to local 
        communities with respect to the development of programs 
        described in paragraph (1);
            (3) provide assistance to local communities in the 
        development of policies to address violence when and if 
        it occurs;
            (4) assist in the creation of community 
        partnerships among law enforcement, education systems 
        and mental health and substance abuse service systems; 
        and
            (5) establish mechanisms for children and 
        adolescents to report incidents of violence or plans by 
        other children or adolescents to commit violence.
    (c) Requirements.--An application for a grant, contract or 
cooperative agreement under subsection (a) shall demonstrate 
that--
            (1) the applicant will use amounts received to 
        create a partnership described in subsection (b)(4) to 
        address issues of violence in schools;
            (2) the activities carried out by the applicant 
        will provide a comprehensive method for addressing 
        violence, that will include--
                    (A) security;
                    (B) educational reform;
                    (C) the review and updating of school 
                policies;
                    (D) alcohol and drug abuse prevention and 
                early intervention services;
                    (E) mental health prevention and treatment 
                services; and
                    (F) early childhood development and 
                psychosocial services; and
            (3) the applicant will use amounts received only 
        for the services described in subparagraphs (D), (E), 
        and (F) of paragraph (2).
    (d) Geographical Distribution.--The Secretary shall ensure 
that grants, contracts or cooperative agreements under 
subsection (a) will be distributed equitably among the regions 
of the country and among urban and rural areas.
    (e) Duration of Awards.--With respect to a grant, contract 
or cooperative agreement under subsection (a), the period 
during which payments under such an award will be made to the 
recipient may not exceed 5 years.
    (f ) Evaluation.--The Secretary shall conduct an evaluation 
of each project carried out under this section and shall 
disseminate the results of such evaluations to appropriate 
public and private entities.
    (g) Information and Education.--The Secretary shall 
establish comprehensive information and education programs to 
disseminate the findings of the knowledge development and 
application under this section to the general public and to 
health care professionals.
    (h) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section, $100,000,000 for 
fiscal year 2001, and such sums as may be necessary for each of 
fiscal years 2002 and 2003.

SEC. 582. [290HH-1] GRANTS TO ADDRESS THE PROBLEMS OF PERSONS WHO 
                    EXPERIENCE VIOLENCE RELATED STRESS.

    (a) In General.--The Secretary shall award grants, 
contracts or cooperative agreements to public and nonprofit 
private entities, as well as to Indian tribes and tribal 
organizations, for the purpose of developing programs focusing 
on the behavioral and biological aspects of psychological 
trauma response and for developing knowledge with regard to 
evidence-based practices for treating psychiatric disorders of 
children and youth resulting from witnessing or experiencing a 
traumatic event.
    (b) Priorities.--In awarding grants, contracts or 
cooperative agreements under subsection (a) related to the 
development of knowledge on evidence-based practices for 
treating disorders associated with psychological trauma, the 
Secretary shall give priority to mental health agencies and 
programs that have established clinical and basic research 
experience in the field of trauma-related mental disorders.
    (c) Geographical Distribution.--The Secretary shall ensure 
that grants, contracts or cooperative agreements under 
subsection (a) with respect to centers of excellence are 
distributed equitably among the regions of the country and 
among urban and rural areas.
    (d) Evaluation.--The Secretary, as part of the application 
process, shall require that each applicant for a grant, 
contract or cooperative agreement under subsection (a) submit a 
plan for the rigorous evaluation of the activities funded under 
the grant, contract or agreement, including both process and 
outcomes evaluation, and the submission of an evaluation at the 
end of the project period.
    (e) Duration of Awards.--With respect to a grant, contract 
or cooperative agreement under subsection (a), the period 
during which payments under such an award will be made to the 
recipient may not exceed 5 years. Such grants, contracts or 
agreements may be renewed.
    (f ) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section, $50,000,000 for 
fiscal year 2001, and such sums as may be necessary for each of 
fiscal years 2003 through 2006.
    (g) Short Title.--This section may be cited as the ``Donald 
J. Cohen National Child Traumatic Stress Initiative''.

  PART H--REQUIREMENT RELATING TO THE RIGHTS OF RESIDENTS OF CERTAIN 
                               FACILITIES

SEC. 591. [290II] REQUIREMENT RELATING TO THE RIGHTS OF RESIDENTS OF 
                    CERTAIN FACILITIES.

    (a) In General.--A public or private general hospital, 
nursing facility, intermediate care facility, or other health 
care facility, that receives support in any form from any 
program supported in whole or in part with funds appropriated 
to any Federal department or agency shall protect and promote 
the rights of each resident of the facility, including the 
right to be free from physical or mental abuse, corporal 
punishment, and any restraints or involuntary seclusions 
imposed for purposes of discipline or convenience.
    (b) Requirements.--Restraints and seclusion may only be 
imposed on a resident of a facility described in subsection (a) 
if--
            (1) the restraints or seclusion are imposed to 
        ensure the physical safety of the resident, a staff 
        member, or others; and
            (2) the restraints or seclusion are imposed only 
        upon the written order of a physician, or other 
        licensed practitioner permitted by the State and the 
        facility to order such restraint or seclusion, that 
        specifies the duration and circumstances under which 
        the restraints are to be used (except in emergency 
        circumstances specified by the Secretary until such an 
        order could reasonably be obtained).
    (c) Current Law.--This part shall not be construed to 
affect or impede any Federal or State law or regulations that 
provide greater protections than this part regarding seclusion 
and restraint.
    (d) Definitions.--In this section:
            (1) Restraints.--The term ``restraints'' means--
                    (A) any physical restraint that is a 
                mechanical or personal restriction that 
                immobilizes or reduces the ability of an 
                individual to move his or her arms, legs, or 
                head freely, not including devices, such as 
                orthopedically prescribed devices, surgical 
                dressings or bandages, protective helmets, or 
                any other methods that involves the physical 
                holding of a resident for the purpose of 
                conducting routine physical examinations or 
                tests or to protect the resident from falling 
                out of bed or to permit the resident to 
                participate in activities without the risk of 
                physical harm to the resident (such term does 
                not include a physical escort); and
                    (B) a drug or medication that is used as a 
                restraint to control behavior or restrict the 
                resident's freedom of movement that is not a 
                standard treatment for the resident's medical 
                or psychiatric condition.
            (2) Seclusion.--The term ``seclusion'' means a 
        behavior control technique involving locked isolation. 
        Such term does not include a time out.
            (3) Physical escort.--The term ``physical escort'' 
        means the temporary touching or holding of the hand, 
        wrist, arm, shoulder or back for the purpose of 
        inducing a resident who is acting out to walk to a safe 
        location.
            (4) Time out.--The term ``time out'' means a 
        behavior management technique that is part of an 
        approved treatment program and may involve the 
        separation of the resident from the group, in a non-
        locked setting, for the purpose of calming. Time out is 
        not seclusion.

SEC. 592. [290II-1] REPORTING REQUIREMENT.

    (a) In General.--Each facility to which the Protection and 
Advocacy for Mentally Ill Individuals Act of 1986 \1\ applies 
shall notify the appropriate agency, as determined by the 
Secretary, of each death that occurs at each such facility 
while a patient is restrained or in seclusion, of each death 
occurring within 24 hours after the patient has been removed 
from restraints and seclusion, or where it is reasonable to 
assume that a patient's death is a result of such seclusion or 
restraint. A notification under this section shall include the 
name of the resident and shall be provided not later than 7 
days after the date of the death of the individual involved.
---------------------------------------------------------------------------
    \1\ Probably should be Protection and Advocacy for Individuals with 
Mental Illness Act. See section 3206(a) of Public Law 106-310 (114 
Stat. 1193).
---------------------------------------------------------------------------
    (b) Facility.--In this section, the term ``facility'' has 
the meaning given the term ``facilities'' in section 102(3) of 
the Protection and Advocacy for Mentally Ill Individuals Act of 
1986 \1\ (42 U.S.C. 10802(3)).

SEC. 593. \2\ [290II-3] REGULATIONS AND ENFORCEMENT.
---------------------------------------------------------------------------

    \2\ Section 593 appears according to the probable intent of the 
Congress. Section 3207 of Public Law 106-310 (114 Stat. 1196) added 
sections 591 and 592, and closing quotations were provided at the end 
of section 592. Immediately following that section, however, section 
593 appeared in quotations, and closing quotations were provided at the 
end of the section. The probable intent of the Congress is that closing 
quotations should not have been provided at the end of section 592.
---------------------------------------------------------------------------
    (a) Training.--Not later than 1 year after the date of the 
enactment of this part, the Secretary, after consultation with 
appropriate State and local protection and advocacy 
organizations, physicians, facilities, and other health care 
professionals and patients, shall promulgate regulations that 
require facilities to which the Protection and Advocacy for 
Mentally Ill Individuals Act of 1986 \1\ (42 U.S.C. 10801 et 
seq.) applies, to meet the requirements of subsection (b).
---------------------------------------------------------------------------
    \1\ See footnote for subsection (a).
---------------------------------------------------------------------------
    (b) Requirements.--The regulations promulgated under 
subsection (a) shall require that--
            (1) facilities described in subsection (a) ensure 
        that there is an adequate number of qualified 
        professional and supportive staff to evaluate patients, 
        formulate written individualized, comprehensive 
        treatment plans, and to provide active treatment 
        measures;
            (2) appropriate training be provided for the staff 
        of such facilities in the use of restraints and any 
        alternatives to the use of restraints; and
            (3) such facilities provide complete and accurate 
        notification of deaths, as required under section 
        592(a).
    (c) Enforcement.--A facility to which this part applies 
that fails to comply with any requirement of this part, 
including a failure to provide appropriate training, shall not 
be eligible for participation in any program supported in whole 
or in part by funds appropriated to any Federal department or 
agency.

PART I--REQUIREMENT RELATING TO THE RIGHTS OF RESIDENTS OF CERTAIN NON-
       MEDICAL, COMMUNITY-BASED FACILITIES FOR CHILDREN AND YOUTH

SEC. 595. [290JJ] REQUIREMENT RELATING TO THE RIGHTS OF RESIDENTS OF 
                    CERTAIN NON-MEDICAL, COMMUNITY-BASED FACILITIES FOR 
                    CHILDREN AND YOUTH.

    (a) Protection of Rights.--
            (1) In general.--A public or private non-medical, 
        community-based facility for children and youth (as 
        defined in regulations to be promulgated by the 
        Secretary) that receives support in any form from any 
        program supported in whole or in part with funds 
        appropriated under this Act shall protect and promote 
        the rights of each resident of the facility, including 
        the right to be free from physical or mental abuse, 
        corporal punishment, and any restraints or involuntary 
        seclusions imposed for purposes of discipline or 
        convenience.
            (2) Nonapplicability.--Notwithstanding this part, a 
        facility that provides inpatient psychiatric treatment 
        services for individuals under the age of 21, as 
        authorized and defined in subsections (a)(16) and (h) 
        of section 1905 of the Social Security Act, shall 
        comply with the requirements of part H.
            (3) Applicability of medicaid provisions.--A non-
        medical, community-based facility for children and 
        youth funded under the Medicaid program under title XIX 
        of the Social Security Act shall continue to meet all 
        existing requirements for participation in such program 
        that are not affected by this part.
    (b) Requirements.--
            (1) In general.--Physical restraints and seclusion 
        may only be imposed on a resident of a facility 
        described in subsection (a) if--
                    (A) the restraints or seclusion are imposed 
                only in emergency circumstances and only to 
                ensure the immediate physical safety of the 
                resident, a staff member, or others and less 
                restrictive interventions have been determined 
                to be ineffective; and
                    (B) the restraints or seclusion are imposed 
                only by an individual trained and certified, by 
                a State-recognized body (as defined in 
                regulation promulgated by the Secretary) and 
                pursuant to a process determined appropriate by 
                the State and approved by the Secretary, in the 
                prevention and use of physical restraint and 
                seclusion, including the needs and behaviors of 
                the population served, relationship building, 
                alternatives to restraint and seclusion, de-
                escalation methods, avoiding power struggles, 
                thresholds for restraints and seclusion, the 
                physiological and psychological impact of 
                restraint and seclusion, monitoring physical 
                signs of distress and obtaining medical 
                assistance, legal issues, position asphyxia, 
                escape and evasion techniques, time limits, the 
                process for obtaining approval for continued 
                restraints, procedures to address problematic 
                restraints, documentation, processing with 
                children, and follow-up with staff, and 
                investigation of injuries and complaints.
            (2) Interim procedures relating to training and 
        certification.--
                    (A) In general.--Until such time as the 
                State develops a process to assure the proper 
                training and certification of facility 
                personnel in the skills and competencies 
                referred in paragraph (1)(B), the facility 
                involved shall develop and implement an interim 
                procedure that meets the requirements of 
                subparagraph (B).
                    (B) Requirements.--A procedure developed 
                under subparagraph (A) shall--
                            (i) ensure that a supervisory or 
                        senior staff person with training in 
                        restraint and seclusion who is 
                        competent to conduct a face-to-face 
                        assessment (as defined in regulations 
                        promulgated by the Secretary), will 
                        assess the mental and physical well-
                        being of the child or youth being 
                        restrained or secluded and assure that 
                        the restraint or seclusion is being 
                        done in a safe manner;
                            (ii) ensure that the assessment 
                        required under clause (i) take place as 
                        soon as practicable, but in no case 
                        later than 1 hour after the initiation 
                        of the restraint or seclusion; and
                            (iii) ensure that the supervisory 
                        or senior staff person continues to 
                        monitor the situation for the duration 
                        of the restraint and seclusion.
            (3) Limitations.--
                    (A) In general.--The use of a drug or 
                medication that is used as a restraint to 
                control behavior or restrict the resident's 
                freedom of movement that is not a standard 
                treatment for the resident's medical or 
                psychiatric condition in nonmedical community-
                based facilities for children and youth 
                described in subsection (a)(1) is prohibited.
                    (B) Prohibition.--The use of mechanical 
                restraints in non-medical, community-based 
                facilities for children and youth described in 
                subsection (a)(1) is prohibited.
                    (C) Limitation.--A non-medical, community-
                based facility for children and youth described 
                in subsection (a)(1) may only use seclusion 
                when a staff member is continuously face-to-
                face monitoring the resident and when strong 
                licensing or accreditation and internal 
                controls are in place.
    (c) Rule of Construction.--
            (1) In general.--Nothing in this section shall be 
        construed as prohibiting the use of restraints for 
        medical immobilization, adaptive support, or medical 
        protection.
            (2) Current law.--This part shall not be construed 
        to affect or impede any Federal or State law or 
        regulations that provide greater protections than this 
        part regarding seclusion and restraint.
    (d) Definitions.--In this section:
            (1) Mechanical restraint.--The term ``mechanical 
        restraint'' means the use of devices as a means of 
        restricting a resident's freedom of movement.
            (2) Physical escort.--The term ``physical escort'' 
        means the temporary touching or holding of the hand, 
        wrist, arm, shoulder or back for the purpose of 
        inducing a resident who is acting out to walk to a safe 
        location.
            (3) Physical restraint.--The term ``physical 
        restraint'' means a personal restriction that 
        immobilizes or reduces the ability of an individual to 
        move his or her arms, legs, or head freely. Such term 
        does not include a physical escort.
            (4) Seclusion.--The term ``seclusion'' means a 
        behavior control technique involving locked isolation. 
        Such term does not include a time out.
            (5) Time out.--The term ``time out'' means a 
        behavior management technique that is part of an 
        approved treatment program and may involve the 
        separation of the resident from the group, in a non-
        locked setting, for the purpose of calming. Time out is 
        not seclusion.

SEC. 595A. [290JJ-1] REPORTING REQUIREMENT.

    Each facility to which this part applies shall notify the 
appropriate State licensing or regulatory agency, as determined 
by the Secretary--
            (1) of each death that occurs at each such 
        facility. A notification under this section shall 
        include the name of the resident and shall be provided 
        not later than 24 hours after the time of the 
        individuals death; and
            (2) of the use of seclusion or restraints in 
        accordance with regulations promulgated by the 
        Secretary, in consultation with the States.

SEC. 595B. [290JJ-2] REGULATIONS AND ENFORCEMENT.

    (a) Training.--Not later than 6 months after the date of 
the enactment of this part, the Secretary, after consultation 
with appropriate State, local, public and private protection 
and advocacy organizations, health care professionals, social 
workers, facilities, and patients, shall promulgate regulations 
that--
            (1) require States that license non-medical, 
        community-based residential facilities for children and 
        youth to develop licensing rules and monitoring 
        requirements concerning behavior management practice 
        that will ensure compliance with Federal regulations 
        and to meet the requirements of subsection (b);
            (2) require States to develop and implement such 
        licensing rules and monitoring requirements within 1 
        year after the promulgation of the regulations referred 
        to in the matter preceding paragraph (1); and
            (3) support the development of national guidelines 
        and standards on the quality, quantity, orientation and 
        training, required under this part, as well as the 
        certification or licensure of those staff responsible 
        for the implementation of behavioral intervention 
        concepts and techniques.
    (b) Requirements.--The regulations promulgated under 
subsection (a) shall require--
            (1) that facilities described in subsection (a) 
        ensure that there is an adequate number of qualified 
        professional and supportive staff to evaluate 
        residents, formulate written individualized, 
        comprehensive treatment plans, and to provide active 
        treatment measures;
            (2) the provision of appropriate training and 
        certification of the staff of such facilities in the 
        prevention and use of physical restraint and seclusion, 
        including the needs and behaviors of the population 
        served, relationship building, alternatives to 
        restraint, de-escalation methods, avoiding power 
        struggles, thresholds for restraints, the physiological 
        impact of restraint and seclusion, monitoring physical 
        signs of distress and obtaining medical assistance, 
        legal issues, position asphyxia, escape and evasion 
        techniques, time limits for the use of restraint and 
        seclusion, the process for obtaining approval for 
        continued restraints and seclusion, procedures to 
        address problematic restraints, documentation, 
        processing with children, and follow-up with staff, and 
        investigation of injuries and complaints; and
            (3) that such facilities provide complete and 
        accurate notification of deaths, as required under 
        section 595A(1).
    (c) Enforcement.--A State to which this part applies that 
fails to comply with any requirement of this part, including a 
failure to provide appropriate training and certification, 
shall not be eligible for participation in any program 
supported in whole or in part by funds appropriated under this 
Act.

   Part G \1\--Services Provided Through Religious Organizations \2\
---------------------------------------------------------------------------

    \1\ There are two parts G in this title. The first was added by 
section 3101 of Public Law 106-310 (114 Stat. 1168) and relates to 
projects for children and violence; that part also begins with section 
581. See page 669. Sections 3207 and 3208 of such Public Law (114 Stat. 
1195, 1197) added parts H and I, respectively.
    Subsequently, part G above was added by section 144 of the 
Community Renewal Tax Relief Act of 2000 (as enacted into law by 
section 1(a)(7) of Public Law 106-554; 114 Stat. 2763A-619), which 
provides that title V of this Act ``is amended by adding at the end the 
following part:'', thereby placing that part G after the part I added 
by Public Law 106-310.
    \2\ Section 1955 of this Act also relates to religious 
organizations as providers of substance abuse services. That section 
was added by section 3305 of Public Law 106-310 (114 Stat. 1212).
---------------------------------------------------------------------------

SEC. 581. \1\ [290KK] APPLICABILITY TO DESIGNATED PROGRAMS.

    (a) Designated Programs.--Subject to subsection (b), this 
part applies to discretionary and formula grant programs 
administered by the Substance Abuse and Mental Health Services 
Administration that make awards of financial assistance to 
public or private entities for the purpose of carrying out 
activities to prevent or treat substance abuse (in this part 
referred to as a ``designated program''). Designated programs 
include the program under subpart II of part B of title XIX 
(relating to formula grants to the States).
    (b) Limitation.--This part does not apply to any award of 
financial assistance under a designated program for a purpose 
other than the purpose specified in subsection (a).
    (c) Definitions.--For purposes of this part (and subject to 
subsection (b)):
            (1) The term ``designated program'' has the meaning 
        given such term in subsection (a).
            (2) The term ``financial assistance'' means a 
        grant, cooperative agreement, or contract.
            (3) The term ``program beneficiary'' means an 
        individual who receives program services.
            (4) The term ``program participant'' means a public 
        or private entity that has received financial 
        assistance under a designated program.
            (5) The term ``program services'' means treatment 
        for substance abuse, or preventive services regarding 
        such abuse, provided pursuant to an award of financial 
        assistance under a designated program.
            (6) The term ``religious organization'' means a 
        nonprofit religious organization.

SEC. 582. [290KK-1] RELIGIOUS ORGANIZATIONS AS PROGRAM PARTICIPANTS.

    (a) In General.--Notwithstanding any other provision of 
law, a religious organization, on the same basis as any other 
nonprofit private provider--
            (1) may receive financial assistance under a 
        designated program; and
            (2) may be a provider of services under a 
        designated program.
    (b) Religious Organizations.--The purpose of this section 
is to allow religious organizations to be program participants 
on the same basis as any other nonprofit private provider 
without impairing the religious character of such 
organizations, and without diminishing the religious freedom of 
program beneficiaries.
    (c) Nondiscrimination Against Religious Organizations.--
            (1) Eligibility as program participants.--Religious 
        organizations are eligible to be program participants 
        on the same basis as any other nonprofit private 
        organization as long as the programs are implemented 
        consistent with the Establishment Clause and Free 
        Exercise Clause of the First Amendment to the United 
        States Constitution. Nothing in this Act shall be 
        construed to restrict the ability of the Federal 
        Government, or a State or local government receiving 
        funds under such programs, to apply to religious 
        organizations the same eligibility conditions in 
        designated programs as are applied to any other 
        nonprofit private organization.
            (2) Nondiscrimination.--Neither the Federal 
        Government nor a State or local government receiving 
        funds under designated programs shall discriminate 
        against an organization that is or applies to be a 
        program participant on the basis that the organization 
        has a religious character.
    (d) Religious Character and Freedom.--
            (1) Religious organizations.--Except as provided in 
        this section, any religious organization that is a 
        program participant shall retain its independence from 
        Federal, State, and local government, including such 
        organization's control over the definition, 
        development, practice, and expression of its religious 
        beliefs.
            (2) Additional safeguards.--Neither the Federal 
        Government nor a State shall require a religious 
        organization to--
                    (A) alter its form of internal governance; 
                or
                    (B) remove religious art, icons, scripture, 
                or other symbols,
        in order to be a program participant.
    (e) Employment Practices.--Nothing in this section shall be 
construed to modify or affect the provisions of any other 
Federal or State law or regulation that relates to 
discrimination in employment. A religious organization's 
exemption provided under section 702 of the Civil Rights Act of 
1964 regarding employment practices shall not be affected by 
its participation in, or receipt of funds from, a designated 
program.
    (f ) Rights of Program Beneficiaries.--
            (1) In general.--If an individual who is a program 
        beneficiary or a prospective program beneficiary 
        objects to the religious character of a program 
        participant, within a reasonable period of time after 
        the date of such objection such program participant 
        shall refer such individual to, and the appropriate 
        Federal, State, or local government that administers a 
        designated program or is a program participant shall 
        provide to such individual (if otherwise eligible for 
        such services), program services that--
                    (A) are from an alternative provider that 
                is accessible to, and has the capacity to 
                provide such services to, such individual; and
                    (B) have a value that is not less than the 
                value of the services that the individual would 
                have received from the program participant to 
                which the individual had such objection.
        Upon referring a program beneficiary to an alternative 
        provider, the program participant shall notify the 
        appropriate Federal, State, or local government agency 
        that administers the program of such referral.
            (2) Notices.--Program participants, public agencies 
        that refer individuals to designated programs, and the 
        appropriate Federal, State, or local governments that 
        administer designated programs or are program 
        participants shall ensure that notice is provided to 
        program beneficiaries or prospective program 
        beneficiaries of their rights under this section.
            (3) Additional requirements.--A program participant 
        making a referral pursuant to paragraph (1) shall--
                    (A) prior to making such referral, consider 
                any list that the State or local government 
                makes available of entities in the geographic 
                area that provide program services; and
                    (B) ensure that the individual makes 
                contact with the alternative provider to which 
                the individual is referred.
            (4) Nondiscrimination.--A religious organization 
        that is a program participant shall not in providing 
        program services or engaging in outreach activities 
        under designated programs discriminate against a 
        program beneficiary or prospective program beneficiary 
        on the basis of religion or religious belief.
    (g) Fiscal Accountability.--
            (1) In general.--Except as provided in paragraph 
        (2), any religious organization that is a program 
        participant shall be subject to the same regulations as 
        other recipients of awards of Federal financial 
        assistance to account, in accordance with generally 
        accepted auditing principles, for the use of the funds 
        provided under such awards.
            (2) Limited audit.--With respect to the award 
        involved, a religious organization that is a program 
        participant shall segregate Federal amounts provided 
        under award into a separate account from non-Federal 
        funds. Only the award funds shall be subject to audit 
        by the government.
    (h) Compliance.--With respect to compliance with this 
section by an agency, a religious organization may obtain 
judicial review of agency action in accordance with chapter 7 
of title 5, United States Code.

SEC. 583. [290KK-2] LIMITATIONS ON USE OF FUNDS FOR CERTAIN PURPOSES.

    No funds provided under a designated program shall be 
expended for sectarian worship, instruction, or 
proselytization.

SEC. 584. [290KK-3] EDUCATIONAL REQUIREMENTS FOR PERSONNEL IN DRUG 
                    TREATMENT PROGRAMS.

    (a) Findings.--The Congress finds that--
            (1) establishing unduly rigid or uniform 
        educational qualification for counselors and other 
        personnel in drug treatment programs may undermine the 
        effectiveness of such programs; and
            (2) such educational requirements for counselors 
        and other personnel may hinder or prevent the provision 
        of needed drug treatment services.
    (b) Nondiscrimination.--In determining whether personnel of 
a program participant that has a record of successful drug 
treatment for the preceding three years have satisfied State or 
local requirements for education and training, a State or local 
government shall not discriminate against education and 
training provided to such personnel by a religious 
organization, so long as such education and training includes 
basic content substantially equivalent to the content provided 
by nonreligious organizations that the State or local 
government would credit for purposes of determining whether the 
relevant requirements have been satisfied.
TITLE VI--ASSISTANCE FOR CONSTRUCTION AND MODERN- IZATION OF HOSPITALS 
                      AND OTHER MEDICAL FACILITIES

                         declaration of purpose

    Sec. 600. [291] The purpose of this title is--
            (a) to assist the several States in the carrying 
        out of their programs for the construction and 
        modernization of such public or other nonprofit 
        community hospitals and other medical facilities as may 
        be necessary, in conjunction with existing facilities, 
        to furnish adequate hospital, clinic, or similar 
        services to all their people;
            (b) to stimulate the development of new or improved 
        types of physical facilities for medical, diagnostic, 
        preventive, treatment, or rehabilitative services; and
            (c) to promote research, experiments, and 
        demonstrations relating to the effective development 
        and utilization of hospital, clinic, or similar 
        services, facilities, and resources, and to promote the 
        coordination of such research, experiments, and 
        demonstrations and the useful application of their 
        results.

    Part A--Grants and Loans for Construction and Modernization of 
                 Hospitals and Other Medical Facilities

  authorization of appropriations for construction and modernization 
                                 grants

    Sec. 601. [291a] In order to assist the States in carrying 
out the purposes of section 600, there are authorized to be 
appropriated--
    (a) for the fiscal year ending June 30, 1974--
            (1) $20,800,000 for grants for the construction of 
        public or other nonprofit facilities for long-term 
        care;
            (2) $70,000,000 for grants for the construction of 
        public or other nonprofit outpatient facilities;
            (3) $15,000,000 for grants for the construction of 
        public or other nonprofit rehabilitation facilities;
    (b) for grants for the construction of public or other 
nonprofit hospitals and public health centers, $150,000,000 for 
the fiscal year ending June 30, 1965, $160,000,000 for the 
fiscal year ending June 30, 1966, $170,000,000 for the fiscal 
year ending June 30, 1967, $180,000,000 each for the next two 
fiscal years, $195,000,000 for the fiscal year ending June 30, 
1970, $147,500,000 for the fiscal year ending June 30, 1971, 
$152,500,000 for the fiscal year ending June 30, 1972, 
$157,500,000 for the fiscal year ending June 30, 1973, and 
$41,400,000 for the fiscal year ending June 30, 1974; and
    (c) for grants for modernization of the facilities referred 
to in paragraphs (a) and (b), $65,000,000 for the fiscal year 
ending June 30, 1971, $80,000,000 for the fiscal year ending 
June 30, 1972, $90,000,000 for the fiscal year ending June 30, 
1973, and $50,000,000 for the fiscal year ending June 30, 1974.

                            state allotments

    Sec. 602. [291b] (a)(1) Each State shall be entitled for 
each fiscal year to an allotment bearing the same ratio to the 
sums appropriated for such year pursuant to subparagraphs (1), 
(2), and (3), respectively, of section 601(a), and to an 
allotment bearing the same ratio to the sums appropriated for 
such year pursuant to section 601(b), as the product of--
            (A) the population of such State, and
            (B) the square of its allotment percentage,
bears to the sum of the corresponding products for all of the 
States.
    (2) For each fiscal year, the Secretary shall, in 
accordance with regulations, make allotments among the States, 
from the sums appropriated for such year under section 601(c), 
on the basis of the population, the financial need, and the 
extent of the need for modernization of the facilities referred 
to in paragraphs (a) and (b) of section 601, of the respective 
States.
    (b)(1) The allotment to any State under subsection (a) for 
any fiscal year which is less than--
            (A) $50,000 for the Virgin Islands, American Samoa, 
        the Trust Territory of the Pacific Islands, or Guam and 
        $100,000 for any other State, in the case of an 
        allotment for grants for the construction of public or 
        other nonprofit rehabilitation facilities.
            (B) $100,000 for the Virgin Islands, American 
        Samoa, the Trust Territory of the Pacific Islands, or 
        Guam and $200,000 for any other State in the case of an 
        allotment for grants for the construction of public or 
        other nonprofit outpatient facilities.
            (C) $200,000 for the Virgin Islands, American 
        Samoa, the Trust Territory of the Pacific Islands, or 
        Guam and $300,000 for any other State in the case of an 
        allotment for grants for the construction of public or 
        other nonprofit facilities for long-term care or for 
        the construction of public or other nonprofit hospitals 
        and public health centers, or for the modernization of 
        facilities referred to in paragraph (a) or (b) of 
        section 601, or
            (D) $200,000 for the Virgin Islands, American 
        Samoa, the Trust Territory of the Pacific Islands, or 
        Guam and $300,000 for any other State in the case of an 
        allotment for grants for the modernization of 
        facilities referred to in paragraphs (a) and (b) of 
        section 601,
shall be increased to that amount, the total of the increases 
thereby required being derived by proportionately reducing the 
allotment from appropriations under such subparagraph or 
paragraph to each of the remaining States under subsection (a) 
of this section, but with such adjustments as may be necessary 
to prevent the allotment of any of such remaining States from 
appropriations under such subparagraph or paragraph from being 
thereby reduced to less than that amount.
    (2) An allotment of the Virgin Islands, American Samoa, the 
Trust Territory of the Pacific Islands, or Guam for any fiscal 
year may be increased as provided in paragraph (1) only to the 
extent it satisfies the Surgeon General, at such time prior to 
the beginning of such year as the Surgeon General may 
designate, that such increase will be used for payments under 
and in accordance with the provisions of this part.
    (c) For the purposes of this part--
            (1) The ``allotment percentage'' for any State 
        shall be 100 per centum less that percentage which 
        bears the same ratio to 50 per centum as the per capita 
        income of such State bears to the per capita income of 
        the United States, except that (A) the allotment 
        percentage shall in no case be more than 75 per centum 
        or less than 33\1/3\ per centum, and (B) the allotment 
        percentage for the Commonwealth of Puerto Rico, Guam, 
        American Samoa, the Trust Territory of the Pacific 
        Islands, and the Virgin Islands shall be 75 per centum.
            (2) The allotment percentages shall be determined 
        by the Surgeon General between July 1 and September 30 
        of each even-numbered year, on the basis of the average 
        of the per capita incomes of each of the States and of 
        the United States for the three most recent consecutive 
        years for which satisfactory data are available from 
        the Department of Commerce, and the States shall be 
        notified promptly thereof. Such determination shall be 
        conclusive for each of the two fiscal years in the 
        period beginning July 1 next succeeding such 
        determination.
            (3) The population of the several States shall be 
        determined on the basis of the latest figures certified 
        by the Department of Commerce.
            (4) The term ``United States'' means (but only for 
        purposes of paragraphs (1) and (2)) the fifty States 
        and the District of Columbia.
    (d)(1) Any sum allotted to a State, other than the Virgin 
Islands, American Samoa, the Trust Territory of the Pacific 
Islands, and Guam for a fiscal year under this section and 
remaining unobligated at the end of such year shall remain 
available to such State, for the purpose for which made, for 
the next two fiscal years (and for such years only), in 
addition to the sums allotted to such State for such purposes 
for such next two fiscal years.
    (2) Any sum allotted to the Virgin Islands, American Samoa, 
the Trust Territory of the Pacific Islands, or Guam for a 
fiscal year under this section and remaining unobligated at the 
end of such year shall remain available to it, for the purpose 
for which made, for the next two fiscal years (and for such 
years only), in addition to the sums allotted to it for such 
purpose for each of such next two fiscal years.
    (e)(1) Upon the request of any State that a specified 
portion of any allotment of such State under subsection (a) for 
any fiscal year be added to any other allotment or allotments 
of such State under such subsection for such year, the 
Secretary shall promptly (but after application of subsection 
(b)) adjust the allotments of such State in accordance with 
such request and shall notify the State agency; except that the 
aggregate of the portions so transferred from an allotment for 
a fiscal year pursuant to this paragraph may not exceed the 
amount specified with respect to such allotment in clause (A), 
(B), (C), or (D), as the case may be, of subsection (b)(1) 
which is applicable to such State.
    (2) In addition to the transfer of portions of allotments 
under paragraph (1), upon the request of any State that a 
specified portion of any allotment of such State under 
subsection (a), other than an allotment for grants for the 
construction of public or other nonprofit rehabilitation 
facilities, be added to another allotment of such State under 
such subsection, other than an allotment for grants for the 
construction of public or other nonprofit hospitals and public 
health centers, and upon simultaneous certification to the 
Secretary by the State agency in such State to the effect 
that--
            (A) it has afforded a reasonable opportunity to 
        make applications for the portion so specified and 
        there have been no approvable applications for such 
        portions, or
            (B) in the case of a request to transfer a portion 
        of an allotment for grants for the construction of 
        public or other nonprofit hospitals and public health 
        centers, use of such portion as requested by such State 
        agency will better carry out the purposes of this 
        title,
the Secretary shall promptly (but after application of 
subsection (b)) adjust the allotments of such State in 
accordance with such request and shall notify the State agency.
    (3) In addition to the transfer of portions of allotments 
under paragraph (1) or (2), upon the request of any State that 
a specified portion of an allotment of such State under 
paragraph (2) of subsection (a) be added to an allotment of 
such State under paragraph (1) of such subsection for grants 
for the construction of public or other nonprofit hospitals and 
public health centers, and upon simultaneous certification by 
the State agency in such State to the effect that the need for 
new public or other nonprofit hospitals and public health 
centers is substantially greater than the need for 
modernization of facilities referred to in paragraph (a) or (b) 
of section 601, the Secretary shall promptly (but after 
application of subsection (b) of this section) adjust the 
allotments of such State in accordance with such request and 
shall notify the State agency.
    (4) After adjustment of allotments of any State, as 
provided in paragraph (1), (2), or (3) of this subsection, the 
allotments as so adjusted shall be deemed to be the State's 
allotments under this section.
    (f) In accordance with regulations, any State may file with 
the Surgeon General a request that a specified portion of an 
allotment to it under this part for grants for construction of 
any type of facility, or for modernization of facilities, be 
added to the corresponding allotment of another State for the 
purpose of meeting a portion of the Federal share of the cost 
of a project for the construction of a facility of that type in 
such other State, or for modernization of a facility in such 
other State, as the case may be. If it is found by the Surgeon 
General (or, in the case of a rehabilitation facility, by the 
Surgeon General and the Secretary) that construction or 
modernization of the facility with respect to which the request 
is made would meet needs of the State making the request and 
that use of the specified portion of such State's allotment, as 
requested by it, would assist in carrying out the purposes of 
this title, such portion of such State's allotment shall be 
added to the corresponding allotment of the other State, to be 
used for the purpose referred to above.

                          general regulations

    Sec. 603. [291c] The Surgeon General, with the approval of 
the Federal Hospital Council and the Secretary of Health, 
Education, and Welfare, shall by general regulations 
prescribe--
    (a) the general manner in which the State agency shall 
determine the priority of projects based on the relative need 
of different areas lacking adequate facilities of various types 
for which assistance is available under this part, giving 
special consideration--
            (1) in the case of projects for the construction of 
        hospitals, to facilities serving areas with relatively 
        small financial resources and, at the option of the 
        State, rural communities;
            (2) in the case of projects for the construction of 
        rehabilitation facilities, to facilities operated in 
        connection with a university teaching hospital which 
        will provide an integrated program of medical, 
        psychological, social, and vocational evaluation and 
        services under competent supervision;
            (3) in the case of projects for modernization of 
        facilities, to facilities serving densely populated 
        areas;
            (4) in the case of projects for construction or 
        modernization of outpatient facilities, to any 
        outpatient facility that will be located in, and 
        provide services for residents of, an area determined 
        by the Secretary to be a rural or urban poverty area;
            (5) to projects for facilities which, alone or in 
        conjunction with other facilities, will provide 
        comprehensive health care, including outpatient and 
        preventive care as well as hospitalization;
            (6) to facilities which will provide training in 
        health or allied health professions; and
            (7) to facilities which will provide to a 
        significant extent, for the treatment of alcoholism;
    (b) general standards of construction and equipment for 
facilities of different classes and in different types of 
location, for which assistance is available under this part;
    (c) criteria for determining needs for general hospital and 
long-term care beds, and needs for hospitals and other 
facilities for which aid under this part is available, and for 
developing plans for the distribution of such beds and 
facilities;
    (d) criteria for determining the extent to which existing 
facilities, for which aid under this part is available, are in 
need of modernization; and
    (e) that the State plan shall provide for adequate 
hospitals, and other facilities for which aid under this part 
is available, for all persons residing in the State, and 
adequate hospitals (and such other facilities) to furnish 
needed services for persons unable to pay therefor. Such 
regulations may also require that before approval of an 
application for a project is recommended by a State agency to 
the Surgeon General for approval under this part, assurance 
shall be received by the State from the applicant that (1) the 
facility or portion thereof to be constructed or modernized 
will be made available to all persons residing in the 
territorial area of the applicant; and (2) there will be made 
available in the facility or portion thereof to be constructed 
or modernized a reasonable volume of services to persons unable 
to pay therefor, but an exception shall be made if such a 
requirement is not feasible from a financial viewpoint.

                              state plans

    Sec. 604. [291d] (a) Any State desiring to participate in 
this part may submit a State plan. Such plan must--
            (1) designate a single State agency as the sole 
        agency for the administration of the plan, or designate 
        such agency as the sole agency for supervising the 
        administration of the plan;
            (2) contain satisfactory evidence that the State 
        agency designated in accordance with paragraph (1) will 
        have authority to carry out such plan in conformity 
        with this part;
            (3) provide for the designation of a State advisory 
        council which shall include (A) representatives of 
        nongovernmental organizations or groups, and of public 
        agencies, concerned with the operation, construction, 
        or utilization of hospital or other facilities for 
        diagnosis, prevention, or treatment of illness or 
        disease, or for provision of rehabilitation services, 
        and representatives particularly concerned with 
        education or training of health professions personnel, 
        and (B) an equal number of representatives of consumers 
        familiar with the need for the services provided by 
        such facilities, to consult with the State agency in 
        carrying out the plan, and provide, if such council 
        does not include any representatives of nongovernmental 
        organizations or groups, or State agencies, concerned 
        with rehabilitation, for consultation with 
        organizations, groups, and State agencies so concerned;
            (4) set forth, in accordance with criteria 
        established in regulations prescribed under section 603 
        and on the basis of a statewide inventory of existing 
        facilities, a survey of need, and (except to the extent 
        provided by or pursuant to such regulations) community, 
        area, or regional plans--
                    (A) the number of general hospital beds and 
                long-term care beds, and the number and types 
                of hospital facilities and facilities for long-
                term care, needed to provide adequate 
                facilities for inpatient care of people 
                residing in the State, and a plan for the 
                distribution of such beds and facilities in 
                service areas throughout the State;
                    (B) the public health centers needed to 
                provide adequate public health services for 
                people residing in the State, and a plan for 
                the distribution of such centers throughout the 
                State;
                    (C) the outpatient facilities needed to 
                provide adequate diagnostic or treatment 
                services to ambulatory patients residing in the 
                State, and a plan for distribution of such 
                facilities throughout the State;
                    (D) the rehabilitation facilities needed to 
                assure adequate rehabilitation services for 
                disabled persons residing in the State, and a 
                plan for distribution of such facilities 
                throughout the State; and
                    (E) effective January 1, 1966, the extent 
                to which existing facilities referred to in 
                section 601 (a) or (b) in the State are in need 
                of modernization;
            (5) set forth a construction and modernization 
        program conforming to the provisions set forth pursuant 
        to paragraph (4) and regulations prescribed under 
        section 603 and providing for construction or 
        modernization of the hospital or long-term care 
        facilities, public health centers, outpatient 
        facilities and rehabilitation facilities which are 
        needed, as determined under the provisions so set forth 
        pursuant to paragraph (4);
            (6) set forth, with respect to each of such types 
        of medical facilities, the relative need, determined in 
        accordance with regulations prescribed under section 
        603, for projects for facilities of that type, and 
        provide for the construction or modernization, insofar 
        as financial resources available therefor and for 
        maintenance and operation make possible, in the order 
        of such relative need;
            (7) provide minimum standards (to be fixed in the 
        discretion of the State) for the maintenance and 
        operation of facilities providing inpatient care which 
        receive aid under this part and, effective July 1, 
        1966, provide for enforcement of such standards with 
        respect to projects approved by the Surgeon General 
        under this part after June 30, 1964;
            (8) provide such methods of administration of the 
        State plan, including methods relating to the 
        establishment and maintenance of personnel standards on 
        a merit basis (except that the Surgeon General shall 
        exercise no authority with respect to the selection, 
        tenure of office, or compensation of any individual 
        employed in accordance with such methods), as are found 
        by the Surgeon General to be necessary for the proper 
        and efficient operation of the plan;
            (9) provide for affording to every applicant for a 
        construction or modernization project an opportunity 
        for a hearing before the State agency;
            (10) provide that the State agency will make such 
        reports, in such form and containing such information, 
        as the Surgeon General may from time to time reasonably 
        require, and will keep such records and afford such 
        access thereto as the Surgeon General may find 
        necessary to assure the correctness and verification of 
        such reports;
            (11) provide that the Comptroller General of the 
        United States or his duly authorized representatives 
        shall have access for the purpose of audit and 
        examination to the records specified in paragraph (10);
            (12) provide that the State agency will from time 
        to time, but not less often than annually, review its 
        State plan and submit to the Surgeon General any 
        modifications thereof which it considers necessary; and
            (13) effective July 1, 1971, provide that before 
        any project for construction or modernization of any 
        general hospital is approved by the State agency there 
        will be reasonable assurance of adequate provision for 
        extended care services (as determined in accordance 
        with regulations) to patients of such hospital when 
        such services are medically appropriate for them, with 
        such services being provided in facilities which (A) 
        are structurally part of, physically connected with, or 
        in immediate proximity to, such hospital, and (B) 
        either (i) are under the supervision of the 
        professional staff of such hospital or (ii) have 
        organized medical staffs and have in effect transfer 
        agreements with such hospital; except that the 
        Secretary may, at the request of the State agency, 
        waive compliance with clause (A) or (B), or both such 
        clauses, as the case may be, in the case of any project 
        if the State agency has determined that compliance with 
        such clause or clauses in such case would be 
        inadvisable.
    (b) The Surgeon General shall approve any State plan and 
any modification thereof which complies with the provisions of 
subsection (a). If any such plan or modification thereof shall 
have been disapproved by the Surgeon General for failure to 
comply with subsection (a), the Federal Hospital Council shall, 
upon request of the State agency, afford it an opportunity for 
hearing. If such Council determines that the plan or 
modification complies with the provisions of such subsection, 
the Surgeon General shall thereupon approve such plan or 
modification.
         approval of projects for construction or modernization
    Sec. 605. [291e] (a) For each project pursuant to a State 
plan approved under this part, there shall be submitted to the 
Surgeon General, through the State agency, an application by 
the State or a political subdivision thereof or by a public or 
other nonprofit agency. If two or more such agencies join in 
the project, the application may be filed by one or more of 
such agencies. Such application shall set forth--
            (1) a description of the site for such project;
            (2) plans and specifications therefor, in 
        accordance with regulations prescribed under section 
        603;
            (3) reasonable assurance that title to such site is 
        or will be vested on one or more of the agencies filing 
        the application or in a public or other nonprofit 
        agency which is to operate the facility on completion 
        of the project;
            (4) reasonable assurance that adequate financial 
        support will be available for the completion of the 
        project and for its maintenance and operation when 
        completed;
            (5) reasonable assurance that all laborers and 
        mechanics employed by contractors or subcontractors in 
        the performance of construction or modernization on the 
        project will be paid wages at rates not less than those 
        prevailing on similar work in the locality as 
        determined by the Secretary of Labor in accordance with 
        the Davis-Bacon Act, as amended (40 U.S.C. 276a--276a-
        5); and the Secretary of Labor shall have with respect 
        to the labor standards specified in this paragraph the 
        authority and functions set forth in Reorganization 
        Plan Numbered 14 of 1950 (15 F.R. 3176; 5 U.S.C. 133z-
        15) and section 2 of the Act of June 13, 1934, as 
        amended (40 U.S.C. 276c); and
            (6) a certification by the State agency of the 
        Federal share for the project.
    (b) The Surgeon General shall approve such application if 
sufficient funds to pay the Federal share of the cost of such 
project are available from the appropriate allotment to the 
State, and if the Surgeon General finds (1) that the 
application contains such reasonable assurance as to title, 
financial support, and payment of prevailing rates of wages; 
(2) that the plans and specifications are in accord with the 
regulations prescribed pursuant to section 603; (3) that the 
application is in conformity with the State plan approved under 
section 604 and contains an assurance that in the operation of 
the project there will be compliance with the applicable 
requirements of the regulations prescribed under section 
603(e), and with State standards for operation and maintenance; 
and (4) that the application has been approved and recommended 
by the State agency, opportunity has been provided, prior to 
such approval and recommendation, for consideration of the 
project by the public or nonprofit private agency or 
organization which has developed the comprehensive regional, 
metropolitan area, or other local area plan or plans referred 
to in section 314(b) covering the area in which such project is 
to be located or, if there is no such agency or organization, 
by the State agency administering or supervising the 
administration of the State plan approved under section 314(a), 
and the application is for a project which is entitled to 
priority over other projects within the State in accordance 
with the regulations prescribed pursuant to section 603(a). 
Notwithstanding the preceding sentence, the Surgeon General may 
approve such an application for a project for construction or 
modernization of a rehabilitation facility only if it is also 
approved by the Secretary of Health, Education, and Welfare.
    (c) No application shall be disapproved until the Surgeon 
General has afforded the State agency an opportunity for a 
hearing.
    (d) Amendment of any approved application shall be subject 
to approval in the same manner as an original application.
    (e) Notwithstanding any other provision of this title, no 
application for an outpatient facility shall be approved under 
this section unless the applicant is (1) a State, political 
subdivision, or public agency, or (2) a corporation or 
association which owns and operates a nonprofit hospital (as 
defined in section 645) or which provides reasonable assurance 
that the services of a general hospital will be available to 
patients of such facility who are in need of hospital 
care.* deg.
               payments for construction or modernization
    Sec. 606. [291f] (a) Upon certification to the Surgeon 
General by the State agency, based upon inspection by it, that 
work has been performed upon a project, or purchases have been 
made, in accordance with the approved plans and specifications, 
and that payment of an installment is due to the applicant, 
such installment shall be paid to the State, from the 
applicable allotment of such State, except that (1) if the 
State is not authorized by law to make payments to the 
applicant, or if the State so requests, the payment shall be 
made directly to the applicant, (2) if the Surgeon General, 
after investigation or otherwise, has reason to believe that 
any act (or failure to act) has occurred requiring action 
pursuant to section 607, payment may, after he has given the 
State agency notice of opportunity for hearing pursuant to such 
section, be withheld, in whole or in part, pending corrective 
action or action based on such hearing, and (3) the total of 
payments under this subsection with respect to such project may 
not exceed an amount equal to the Federal share of the cost of 
construction of such project.* deg.
    (b) In case an amendment to an approved application is 
approved as provided in section 605 or the estimated cost of a 
project is revised upward, any additional payment with respect 
thereto may be made from the applicable allotment of the State 
for the fiscal year in which such amendment or revision is 
approved.
    (c)(1) At the request of any State, a portion of any 
allotment or allotments of such State under this part shall be 
available to pay one-half (or such smaller share as the State 
may request) of the expenditures found necessary by the Surgeon 
General for the proper and efficient administration during such 
year of the State plan approved under this part; except that 
not more than 4 per centum of the total of the allotments of 
such State for a year, or $100,000, whichever is less, shall be 
available for such purpose for such year. Payments of amounts 
due under this paragraph may be made in advance or by way of 
reimbursement, and in such installments, as the Surgeon General 
may determine.
    (2) Any amount paid under paragraph (1) to any State for 
any fiscal year shall be paid on condition that there shall be 
expended from State sources for such year for administration of 
the State plan approved under this part not less than the total 
amount expended for such purposes from such sources during the 
fiscal year ending June 30, 1970.
                        withholding of payments
    Sec. 607. [291g] Whenever the Surgeon General, after 
reasonable notice and opportunity for hearing to the State 
agency designated as provided in section 604(a)(1), finds--
            (a) that the State agency is not complying 
        substantially with the provisions required by section 
        604 to be included in its State plan; or
            (b) that any assurance required to be given in an 
        application filed under section 605 is not being or 
        cannot be carried out; or
            (c) that there is a substantial failure to carry 
        out plans and specifications approved by the Surgeon 
        General under section 605; or
            (d) that adequate State funds are not being 
        provided annually for the direct administration of the 
        State plan,
the Surgeon General may forthwith notify the State agency 
that--
            (e) no further payments will be made to the State 
        under this part, or
            (f) no further payments will be made from the 
        allotments of such State from appropriations under any 
        one or more subparagraphs or paragraphs of section 601, 
        or for any project or projects, designated by the 
        Surgeon General as being affected by the action or 
        inaction referred to in paragraph (a), (b), (c), or (d) 
        of this section, as the Surgeon General may determine 
        to be appropriate under the circumstances; and, except 
        with regard to any project for which the application 
        has already been approved and which is not directly 
        affected, further payments may be withheld, in whole or 
        in part, until there is no longer any failure to comply 
        (or carry out the assurance or plans and specifications 
        or provide adequate State funds, as the case may be) 
        or, if such compliance (or other action) is impossible, 
        until the State repays or arranges for the repayment of 
        Federal moneys to which the recipient was not entitled.
                            judicial review
    Sec. 608. [291h] (a) If the Surgeon General refuses to 
approve any application for a project submitted under section 
605 or section 610, the State agency through which such 
application was submitted, or if any State is dissatisfied with 
his action under section 607 such State may appeal to the 
United States court of appeals for the circuit in which such 
State is located, by filing a petition with such court within 
sixty days after such action. A copy of the petition shall be 
forthwith transmitted by the clerk of the court to the Surgeon 
General, or any officer designated by him for that purpose. The 
Surgeon General shall thereupon file in the court the record of 
the proceedings on which he based his action, as provided in 
section 2112 of title 28, United States Code. Upon the filing 
of such petition, the court shall have jurisdiction to affirm 
the action of the Surgeon General or to set it aside, in whole 
or in part, temporarily or permanently, but until the filing of 
the record, the Surgeon General may modify or set aside his 
order.
    (b) The findings of the Surgeon General as to the facts, if 
supported by substantial evidence, shall be conclusive, but the 
court, for good cause shown, may remand the case to the Surgeon 
General to take further evidence, and the Surgeon General may 
thereupon make new or modified findings of fact and may modify 
his previous action, and shall file in the court the record of 
the further proceedings. Such new or modified findings of fact 
shall likewise be conclusive if supported by substantial 
evidence.
    (c) The judgment of the court affirming or setting aside, 
in whole or in part, any action of the Surgeon General shall be 
final, subject to review by the Supreme Court of the United 
States upon certiorari or certification as provided in section 
1254 of title 28, United States Code. The commencement of 
proceedings under this section shall not, unless so 
specifically ordered by the court, operate as a stay of the 
Surgeon General's action.
                                recovery
    Sec. 609. \1\ [291i] (a) If any facility with respect to 
which funds have been paid under section 606 shall, at any time 
within 20 years after the completion of construction or 
modernization--
---------------------------------------------------------------------------
    \1\ Subtitle D of title VII of Public Law 100-607 waived the 
applicability of section 609 regarding a specified medical facility if 
certain conditions relating to satisfaction of the obligations under 
section 603(e) were met. (The text of such subtitle D is provided in 
this compilation under the heading ``Waiver Regarding Title VI of 
Public Health Service Act''.) Private Law 99-21 provided such a waiver 
regarding another specified medical facility.
---------------------------------------------------------------------------
            (1) be sold or transferred to any entity (A) which 
        is not qualified to file an application under section 
        605, or (B) which is not approved as a transferee by 
        the State agency designated pursuant to section 604, or 
        its successor, or
            (2) cease to be a public health center or a public 
        or other nonprofit hospital, outpatient facility, 
        facility for long-term care, or rehabilitation 
        facility,
the United States shall be entitled to recover, whether from 
the transferor or the transferee (or, in the case of a facility 
which has ceased to be public or nonprofit, from the owners 
thereof) an amount determined under subsection (c).
    (b) The transferor of a facility which is sold or 
transferred as described in subsection (a)(1), or the owner of 
a facility the use of which is changed as described in 
subsection (a)(2), shall provide the Secretary written notice 
of such sale, transfer, or change not later than the expiration 
of 10 days from the date on which such sale, transfer, or 
change occurs.
    (c)(1) except as provided in paragraph (2), the amount the 
United States shall be entitled to recover under subsection (a) 
is an amount bearing the same ratio to the then value (as 
determined by the agreement of the parties or in an action 
brought in the district court of the United States for the 
district for which the facility involved is situated) of so 
much of the facility as constituted an approved project or 
projects as the amount of the Federal participation bore to the 
cost of the construction or modernization of such project or 
projects.
    (2)(A) After the expiration of--
            (i) 180 days after the date of the sale, transfer, 
        or change of use for which a notice is required by 
        subsection (b), in the case of a facility which is sold 
        or transferred or the use of which changes after the 
        date of the enactment of this subsection, or
            (ii) thirty days after the date of the enactment of 
        this subsection or if later 180 days after the date of 
        the sale, transfer, or change of use for which a notice 
        is required by subsection (b), in the case of a 
        facility which was sold or transferred or the use of 
        which changed before the date of the enactment of this 
        subsection. \1\
---------------------------------------------------------------------------
        \1\ So in law. The period probably should be a comma.
---------------------------------------------------------------------------
the amount which the United States is entitled to recover under 
paragraph (1) with respect to a facility shall be the amount 
prescribed by paragraph (1) plus interest, during the period 
described in subparagraph (B), at a rate (determined by the 
Secretary) based on the average of the bond equivalent of the 
weekly ninety-day Treasury bill auction rate.
    (B) The period referred to in subparagraph (A) is the 
period beginning--
            (i) in the case of a facility which was sold or 
        transferred or the use of which changed before the date 
        of the enactment of this subsection, thirty days after 
        such date or if later 180 days after the date of the 
        sale, transfer, or change of use for which a notice is 
        required by subsection (b),
            (ii) in the case of a facility with respect to 
        which notice is provided in accordance with subsection 
        (b), upon the expiration of 180 days after the receipt 
        of such notice, or
            (iii) in the case of a facility with respect to 
        which such notice is not provided as prescribed by 
        subsection (b), on the date of the sale, transfer, or 
        change of use for which such notice was to be provided,
and ending on the date the amount the United States is entitled 
to under paragraph (1) is collected.
    (d)(1) The Secretary may waive the recovery rights of the 
United States under subsection (a)(1) with respect to a 
facility in any State if the Secretary determines, in 
accordance with regulations, that the entity to which the 
facility was sold or transferred--
            (A) has established an irrevocable trust--
                    (i) in an amount equal to the greater of 
                twice the cost of the remaining obligation of 
                the facility under clause (2) of section 603(e) 
                or the amount, determined under subsection (c), 
                that the United States is entitled to recover, 
                and
                    (ii) which will only be used by the entity 
                to provide the care required by clause (2) of 
                section 603(e); and
            (B) will meet the obligation of the facility under 
        clause (1) of section 603(e).
    (2) The Secretary may waive the recovery rights of the 
United States under subsection (a)(2) with respect to a 
facility in any State if the Secretary determines, in 
accordance with regulations, that there is good cause for 
waiving such rights with respect to such facility.
    (e) The right of recovery of the United States under 
subsection (a) shall not constitute a lien on any facility with 
respect to which funds have been paid under section 606.

loans for construction or modernization of hospitals and other medical 
                               facilities

    Sec. 610. [291j] (a) In order further to assist the States 
in carrying out the purposes of this title, the Surgeon General 
is authorized to make a loan of funds to the applicant for any 
project for construction or modernization which meets all of 
the conditions specified for a grant under this part.
    (b) Except as provided in this section, an application for 
a loan with respect to any project under this part shall be 
submitted, and shall be approved by the Surgeon General, in 
accordance with the same procedures and subject to the same 
limitations and conditions as would be applicable to the making 
of a grant under this part for such project. Any such 
application may be approved in any fiscal year only if 
sufficient funds are available from the allotment for the type 
of project involved. All loans under this section shall be paid 
directly to the applicant.
    (c)(1) The amount of a loan under this part shall not 
exceed an amount equal to the Federal share of the estimated 
cost of construction or modernization under the project. Where 
a loan and a grant are made under this part with respect to the 
same project, the aggregate amount of such loan and such grant 
shall not exceed an amount equal to the Federal share of the 
estimated cost of construction or modernization under the 
project. Each loan shall bear interest at the rate arrived at 
by adding one-quarter of 1 per centum per annum to the rate 
which the Secretary of the Treasury determines to be equal to 
the current average yield on all outstanding marketable 
obligations of the United States as of the last day of the 
month preceding the date the application for the loan is 
approved and by adjusting the result so obtained to the nearest 
one-eighth of 1 per centum. Each loan made under this part 
shall mature not more than forty years after the date on which 
such loan is made, except that nothing in this part shall 
prohibit the payment of all or part of the loan at any time 
prior to the maturity date. In addition to the terms and 
conditions provided for, each loan under this part shall be 
made subject to such terms, conditions, and covenants relating 
to repayment of principal, payment of interest, and other 
matters as may be agreed upon by the applicant and the Surgeon 
General.
    (2) The Surgeon General may enter into agreements modifying 
any of the terms and conditions of a loan made under this part 
whenever he determines such action is necessary to protect the 
financial interest of the United States.
    (3) If, at any time before a loan for a project has been 
repaid in full, any of the events specified in clause (a) or 
clause (b) of section 609 occurs with respect to such project, 
the unpaid balance of the loan shall become immediately due and 
payable by the applicant, and any transferee of the facility 
shall be liable to the United States for such repayment.
    (d) Any loan under this part shall be made out of the 
allotment from which a grant for the project concerned would be 
made. Payments of interest and repayments of principal on loans 
under this part shall be deposited in the Treasury as 
miscellaneous receipts.

Part B--Loan Guarantees and Loans for Modernization and Construction of 
                 Hospitals and Other Medical Facilities

               authorization of loan guarantees and loans

    Sec. 621. [291j-1] (a)(1) In order to assist nonprofit 
private agencies to carry out needed projects for the 
modernization or construction of nonprofit private hospitals, 
facilities for long-term care, outpatient facilities, and 
rehabilitation facilities, the Secretary, during the period 
July 1, 1970, through June 30, 1974, may, in accordance with 
the provisions of this part, guarantee to non-Federal lenders 
making loans to such agencies for such projects, payment of 
principal of and interest on loans, made by such lenders, which 
are approved under this part.
    (2) In order to assist public agencies to carry out needed 
projects for the modernization or construction of public health 
centers, and public hospitals, facilities for long-term care, 
outpatient facilities, and rehabilitation facilities, the 
Secretary, during the period July 1, 1970, through June 30, 
1974, may, in accordance with the provisions of this part, make 
loans to such agencies which shall be sold and guaranteed in 
accordance with section 627.
    (b)(1) No loan guarantee under this part with respect to 
any modernization or construction project may apply to so much 
of the principal amount thereof as, when added to the amount of 
any grant or loan under part A with respect to such project, 
exceeds 90 per centum of the cost of such project.
    (2) No loan to a public agency under this part shall be 
made in an amount which, when added to the amount of any grant 
or loan under part A with respect to such project, exceeds 90 
per centum of the cost of such project.
    (c) The Secretary, with the consent of the Secretary of 
Housing and Urban Development, shall obtain from the Department 
of Housing and Urban Development such assistance with respect 
to the administration of this part as will promote efficiency 
and economy thereof.

                      allocation among the states

    Sec. 622. [291j-2] (a) For each fiscal year, the total 
amount of principal of loans to nonprofit private agencies 
which may be guaranteed or loans to public agencies which may 
be directly made under this part shall be allotted by the 
Secretary among the States, in accordance with regulations, on 
the basis of each State's relative population, financial need, 
need for construction of the facilities referred to in section 
621(a), and need for modernization of such facilities.
    (b) Any amount allotted under subsection (a) to a State for 
a fiscal year ending before July 1, 1973, and remaining 
unobligated at the end of such year shall remain available to 
such State, for the purpose for which made, for the next two 
fiscal years (and for such years only), and any such amount 
shall be in addition to the amounts allotted to such State for 
such purpose for each of such next two fiscal years; except 
that, with the consent of any such State, any such amount 
remaining unobligated at the end of the first of such next 
fiscal year may be reallotted (on such basis as the Secretary 
deems equitable and consistent with the purposes of this title) 
to other States which have need therefor. Any amounts so 
reallotted to a State shall be available for the purposes for 
which made until the close of the second such next two fiscal 
years and shall be in addition to the amount allotted and 
available to such State for the same period.
    (c) Any amount allotted or reallotted to a State under this 
section for a fiscal year shall not, until the expiration of 
the period during which it is available for obligation, be 
considered as available for allotment for a subsequent fiscal 
year.
    (d) The allotments of any State under subsection (a) for 
the fiscal year ending June 30, 1971, and the succeeding fiscal 
year shall also be available to guarantee loans with respect to 
any project, for modernization or construction of a nonprofit 
private hospital or other health facility referred to in 
section 621(a)(1), if the modernization or construction of such 
facility was not commenced earlier than January 1, 1968, and if 
the State certifies and the Secretary finds that without such 
guaranteed loan such facility could not be completed and begin 
to operate or could not continue to operate, but with such 
guaranteed loan would be able to do so: Provided, That this 
subsection shall not apply to more than two projects in any one 
State.

                      applications and conditions

    Sec. 623. [291j-3] (a) For each project for which a 
guarantee of a loan to a nonprofit private agency or a direct 
loan to a public agency is sought under this part, there shall 
be submitted to the Secretary, through the State agency 
designated in accordance with section 604, an application by 
such private nonprofit agency or by such public agency. If two 
or more private nonprofit agencies, or two or more public 
agencies, join in the project, the application may be filed by 
one or more such agencies. Such application shall (1) set forth 
all of the descriptions, plans, specifications, assurances, and 
information which are required by the third sentence of section 
605(a) (other than clause (6) thereof) with respect to 
applications submitted under that section, (2) contain such 
other information as the Secretary may require to carry out the 
purposes of this part, and (3) include a certification by the 
State agency of the total cost of the project and the amount of 
the loan for which a guarantee is sought under this part, or 
the amount of the direct loan sought under this part, as the 
case may be.
    (b) The Secretary may approve such application only if--
            (1) there remains sufficient balance in the 
        allotment determined for such State pursuant to section 
        622 to cover the amount of the loan for which a 
        guarantee is sought, or the amount of the direct loan 
        sought (as the case may be), in such application,
            (2) he makes each of the findings which are 
        required by clauses (1) through (4) of section 605(b) 
        for the approval of applications for projects 
        thereunder (except that, in the case of the finding 
        required under such clause (4) of entitlement of a 
        project to a priority established under section 603(a), 
        such finding shall be made without regard to the 
        provisions of clauses (1) and (3) of such section),
            (3) he finds that there is compliance with section 
        605(e),
            (4) he obtains assurances that the applicant will 
        keep such records, and afford such access thereto, and 
        make such reports, in such form and containing such 
        information, as the Secretary may reasonably require, 
        and
            (5) he also determines, in the case of a loan for 
        which a guarantee is sought, that the terms, 
        conditions, maturity, security (if any), and schedule 
        and amounts of repayments with respect to the loan are 
        sufficient to protect the financial interests of the 
        United States and are otherwise reasonable and in 
        accord with regulations, including a determination that 
        the rate of interest does not exceed such per centum 
        per annum on the principal obligation outstanding as 
        the Secretary determines to be reasonable, taking into 
        account the range of interest rates prevailing in the 
        private market for similar loans and the risks assumed 
        by the United States.
    (c) No application under this section shall be disapproved 
until the Secretary has afforded the State agency an 
opportunity for a hearing.
    (d) Amendment of an approved application shall be subject 
to approval in the same manner as an original application.
    (e)(1) In the case of any loan to a nonprofit private 
agency, the United States shall be entitled to recover from the 
applicant the amount of any payments made pursuant to any 
guarantee of such loan under this part, unless the Secretary 
for good cause waives its right of recovery, and, upon making 
any such payment, the United States shall be subrogated to all 
of the rights of the recipient of the payments with respect to 
which the guarantee was made.
    (2) Guarantees of loans to nonprofit private agencies under 
this part shall be subject to such further terms and conditions 
as the Secretary determines to be necessary to assure that the 
purposes of this part will be achieved, and, to the extent 
permitted by subsection (f), any of such terms and conditions 
may be modified by the Secretary to the extent he determines it 
to be consistent with the financial interest of the United 
States.
    (f) Any guarantee of a loan to a nonprofit private agency 
made by the Secretary pursuant to this part shall be 
incontestable in the hands of an applicant on whose behalf such 
guarantee is made, and as to any person who makes or contracts 
to make a loan to such applicant in reliance thereon, except 
for fraud or misrepresentation on the part of such applicant or 
such other person.

                 payment of interest on guaranteed loan

    Sec. 624. [291j-4] (a) Subject to the provisions of 
subsection (b), in the case of a guarantee of any loan to a 
nonprofit private agency under this part with respect to a 
hospital or other medical facility, the Secretary shall pay, to 
the holder of such loan and for and on behalf of such hospital 
or other medical facility amounts sufficient to reduce by 3 per 
centum per annum the net effective interest rate otherwise 
payable on such loan. Each holder of a loan, to a nonprofit 
private agency, which is guaranteed under this part shall have 
a contractual right to receive from the United States interest 
payments required by the preceding sentence.
    (b) Contracts to make the payments provided for in this 
section shall not carry an aggregate amount greater than such 
amount as may be provided in appropriations Acts.

       limitation on amount of loans guaranteed or directly made

    Sec. 625. [291j-5] The cumulative total of the principal of 
the loans outstanding at any time with respect to which 
guarantees have been issued, or which have been directly made, 
under this part may not exceed the lesser of--
            (1) such limitations as may be specified in 
        appropriations Acts, or
            (2) in the case of loans covered by allotments for 
        the fiscal year ending June 30, 1971, $500,000,000; for 
        the fiscal year ending June 30, 1972, $1,000,000,000; 
        and for each of the fiscal years ending June 30, 1973, 
        and June 30, 1974.

                      loan guarantee and loan fund

    Sec. 626. [291j-6] (a)(1) There is hereby established in 
the Treasury a loan guarantee and loan fund (hereinafter in 
this section referred to as the ``fund'') which shall be 
available to the Secretary without fiscal year limitation, in 
such amounts as may be specified from time to time in 
appropriations Acts, (i) to enable him to discharge his 
responsibilities under guarantees issued by him under this 
part, (ii) for payment of interest on the loans to nonprofit 
agencies which are guaranteed, (iii) for direct loans to public 
agencies which are sold and guaranteed, (iv) for payment of 
interest with respect to such loans, and (v) for repurchase by 
him of direct loans to public agencies which have been sold and 
guaranteed. There are authorized to be appropriated to the fund 
from time to time such amounts as may be necessary to provide 
capital required for the fund. To the extent authorized from 
time to time in appropriation Acts, there shall be deposited in 
the fund amounts received by the Secretary as interest payments 
or repayments of principal on loans and any other moneys, 
property, or assets derived by him from his operations under 
this part, including any moneys derived from the sale of 
assets.
    (2) Of the moneys in the fund, there shall be available to 
the Secretary for the purpose of making of direct loans to 
public agencies only such sums as shall have been appropriated 
for such purpose pursuant to section 627 or sums received by 
the Secretary from the sale of such loans (in accordance with 
such section) and authorized in appropriations Acts to be used 
for such purpose.
    (b) If at any time the moneys in the fund are insufficient 
to enable the Secretary to discharge his responsibilities under 
this part--
            (i) \1\ to make payments of interest on loans to 
        nonprofit private agencies which he has guaranteed 
        under this part;
---------------------------------------------------------------------------
    \1\ Clauses (i) through (v) probably should be redesignated as 
paragraphs (1) through (5), respectively. See section 201 of Public Law 
91-296 (84 Stat. 347).
---------------------------------------------------------------------------
            (ii) \1\ to otherwise comply with guarantees under 
        this part of loans to nonprofit private agencies;
            (iii) \1\ to make payments of interest subsidies 
        with respect to loans to public agencies which he has 
        made, sold, and guaranteed under this part;
            (iv) \1\ in the event of default by public agencies 
        to make payments of principal and interest on loans 
        which the Secretary has made, sold, and guaranteed, 
        under this part, to make such payments to the purchaser 
        of such loan;
            (v) \1\ to repurchase loans to public agencies 
        which have been sold and guaranteed under this part,
he is authorized to issue to the Secretary of the Treasury 
notes or other obligations in such forms and denominations, 
bearing such maturities, and subject to such terms and 
conditions, as may be prescribed by the Secretary with the 
approval of the Secretary of the Treasury, but only in such 
amounts as may be specified from time to time in appropriations 
Acts. Such notes or other obligations shall bear interest at a 
rate determined by the Secretary of the Treasury, taking into 
consideration the current average market yield on outstanding 
marketable obligations of the United States of comparable 
maturities during the month preceding the issuance of the notes 
or other obligations. The Secretary of the Treasury is 
authorized and directed to purchase any notes and other 
obligations issued hereunder and for that purpose he is 
authorized to use as a public debt transaction the proceeds 
from the sale of any securities issued under the Second Liberty 
Bond Act, as amended, and the purposes for which securities may 
be issued under that Act, as amended, are extended to include 
any purchase of such notes and obligations. The Secretary of 
the Treasury may at any time sell any of the notes or other 
obligations acquired by him under this subsection. All 
redemptions, purchases, and sales by the Secretary of the 
Treasury of such notes or other obligations shall be treated as 
public debt transactions of the United States. Sums borrowed 
under this subsection shall be deposited in the fund and 
redemption of such notes and obligations shall be made by the 
Secretary from such fund.

          provisions applicable to loans to public facilities

    Sec. 627. [291j-7] (a)(1) Any loan made by the Secretary to 
a public agency under this part for the modernization or 
construction of a public hospital or other health facility 
shall require such public agency to pay interest thereon at a 
rate comparable to the current rate of interest prevailing with 
respect to loans, to nonprofit private agencies, which are 
guaranteed under this part, for the modernization or 
construction of similar facilities in the same or similar 
areas, minus 3 per centum per annum.
    (2)(A) No loan to a public agency shall be made under this 
part unless--
            (i) the Secretary is reasonably satisfied that such 
        agency will be able to make payments of principal and 
        interest thereon when due, and
            (ii) such agency provides the Secretary with 
        reasonable assurances that there will be available to 
        such agency such additional funds as may be necessary 
        to complete the project with respect to which such loan 
        is requested.
    (B) Any loan to a public agency shall have such security, 
have such maturity date, be repayable in such installments, and 
be subject to such other terms and conditions (including 
provision for recovery in case of default) as the Secretary 
determines to be necessary to carry out the purposes of this 
part while adequately protecting the financial interests of the 
United States.
    (3) In making loans to public agencies under this part, the 
Secretary shall give due regard to achieving an equitable 
geographical distribution of such loans.
    (b)(1) The Secretary shall from time to time, but with due 
regard to the financial interests of the United States, sell 
loans referred to in subsection (a)(1) either on the private 
market or to the Federal National Mortgage Association in 
accordance with section 302 of the Federal National Mortgage 
Association Charter Act.
    (2) Any loan so sold shall be sold for an amount which is 
equal (or approximately equal) to the amount of the unpaid 
principal of such loan as of the time of sale.
    (c)(1) The Secretary is authorized to enter into an 
agreement with the purchaser of any loan sold under this part 
under which the Secretary agrees--
            (A) to guarantee to such purchaser (and any 
        successor in interest to such purchaser) payments of 
        the principal and interest payable under such loan, and
            (B) to pay as an interest subsidy to such purchaser 
        (and any successor in interest of such purchaser) 
        amounts which when added to the amount of interest 
        payable on such loan, are equivalent to a reasonable 
        rate of interest on such loan as determined by the 
        Secretary, after taking into account the range of 
        prevailing interest rates in the private market on 
        similar loans and the risks assumed by the United 
        States.
    (2) Any such agreement--
            (A) may provide that the Secretary shall act as 
        agent of any such purchaser, for the purpose of 
        collecting from the public agency to which such loan 
        was made and paying over to such purchaser, any 
        payments of principal and interest payable by such 
        agency under such loan;
            (B) may provide for the repurchase by the Secretary 
        of any such loan on such terms and conditions as may be 
        specified in the agreement;
            (C) shall provide that, in the event of any default 
        by the public agency to which such loan was made in 
        payment of principal and interest due on such loan, the 
        Secretary shall, upon notification to the purchaser (or 
        to the successor in interest of such purchaser), have 
        the option to close out such loan (and any obligations 
        of the Secretary with respect thereto) by paying to the 
        purchaser (or his successor in interest) the total 
        amount of outstanding principal and interest due 
        thereon at the time of such notification; and
            (D) shall provide that, in the event such loan is 
        closed out as provided in subparagraph (C), or in the 
        event of any other loss incurred by the Secretary by 
        reason of the failure of such public agency to make 
        payments of principal and interest on such loan, the 
        Secretary shall be subrogated to all rights of such 
        purchaser for recovery of such loss from such public 
        agency.
    (d) The Secretary may, for good cause, waive any right of 
recovery which he has against a public agency by reason of the 
failure of such agency to make payments of principal and 
interest on a loan made to such agency under this part.
    (e) After any loan to a public agency under this part has 
been sold and guaranteed, interest paid on such loan and any 
interest subsidy paid by the Secretary with respect to such 
loan which is received by the purchaser thereof (or his 
successor in interest) shall be included in gross income for 
the purposes of chapter 1 of the Internal Revenue Code of 1954.
    (f) Amounts received by the Secretary as proceeds from the 
sale of loans under this section shall be deposited in the loan 
fund established by section 626, and shall be available to the 
Secretary for the making of further loans under this part in 
accordance with the provisions of subsection (a)(2) of such 
section.
    (g) There is authorized to be appropriated to the 
Secretary, for deposit in the loan fund established by section 
626, $30,000,000 to provide initial capital for the making of 
direct loans by the Secretary to public agencies for the 
modernization or construction of facilities referred to in 
subsection (a)(1).

        Part C--Construction or Modernization of Emergency Rooms

                             authorization

    Sec. 631. [291j-8] In order to assist in the provision of 
adequate emergency room service in various communities of the 
Nation for treatment of accident victims and handling of other 
medical emergencies through special project grants for the 
construction or modernization of emergency rooms of general 
hospitals, there are authorized to be appropriated $20,000,000 
each for the fiscal year ending June 30, 1971, and the next two 
fiscal years.

                         eligibility for grants

    Sec. 632. [291j-9] Funds appropriated pursuant to section 
631 shall be available for grants by the Secretary for not to 
exceed 50 per centum of the cost of construction or 
modernization of emergency rooms of public or nonprofit general 
hospitals, including provision or replacement of medical 
transportation facilities. Such grants shall be made by the 
Secretary only after consultation with the State agency 
designated in accordance with section 604(a)(1) of the Public 
Health Service Act. In order to be eligible for a grant under 
this part, the project, and the applicant therefor, must meet 
such criteria as may be prescribed by regulations. Such 
regulations shall be so designed as to provide aid only with 
respect to projects for which adequate assistance is not 
readily available from other Federal, State, local, or other 
sources, and to assist in providing modern, efficient, and 
effective emergency room service needed to care for victims of 
highway, industrial, agricultural, or other accidents and to 
handle other medical emergencies, and to assist in providing 
such service in geographical areas which have special need 
therefor.

                                payments

    Sec. 633. [291j-10] Grants under this part shall be paid in 
advance or by way of reimbursement, in such installments and on 
such conditions, as in the judgment of the Secretary will best 
carry out the purposes of this part.

                            Part D--General

            federal hospital council and advisory committees

    Sec. 641. [291k] (a) In administering this title, the 
Surgeon General shall consult with a Federal Hospital Council 
consisting of the Surgeon General, who shall serve as Chairman 
ex officio, and twelve members appointed by the Secretary of 
Health, Education, and Welfare. Six of the twelve appointed 
members shall be persons who are outstanding in fields 
pertaining to medical facility and health activities, and three 
of these six shall be authorities in matters relating to the 
operation of hospitals or other medical facilities, one of them 
shall be an authority in matters relating to the mentally 
retarded, and one of them shall be an authority in matters 
relating to mental health, and the other six members shall be 
appointed to represent the consumers of services provided by 
such facilities and shall be persons familiar with the need for 
such services in urban or rural areas.
    (b) Each appointed member shall hold office for a term of 
four years, except that any member appointed to fill a vacancy 
occurring prior to the expiration of the term for which his 
predecessor was appointed shall be appointed for the remainder 
of such term. An appointed member shall not be eligible to 
serve continuously for more than two terms (whether beginning 
before or after enactment of this section) but shall be 
eligible for reappointment if he has not served immediately 
preceding his reappointment.
    (c) The Council shall meet as frequently as the Surgeon 
General deems necessary, but not less than once each year. Upon 
request by three or more members, it shall be the duty of the 
Surgeon General to call a meeting of the Council.
    (d) The Council is authorized to appoint such special 
advisory or technical committees as may be useful in carrying 
out its functions.

                      conference of state agencies

    Sec. 642. [291l] Whenever in his opinion the purposes of 
this title would be promoted by a conference, the Surgeon 
General may invite representatives of as many State agencies, 
designated in accordance with section 604, to confer as he 
deems necessary or proper. A conference of the representatives 
of all such State agencies shall be called annually by the 
Surgeon General. Upon the application of five or more of such 
State agencies, it shall be the duty of the Surgeon General to 
call a conference of representatives of all State agencies 
joining in the request.

                      state control of operations

    Sec. 643. [291m] Except as otherwise specifically provided, 
nothing in this title shall be construed as conferring on any 
Federal office or employee the right to exercise any 
supervision or control over the administration, personnel, 
maintenance, or operation of any facility with respect to which 
any funds have been or may be expended under this title.

          loans for certain hospital experimentation projects

    Sec. 643A. [291m-1] (a) In order to alleviate hardship on 
any recipient of a grant under section 636 of this title (as in 
effect immediately before the enactment of the Hospital and 
Medical Facilities Amendments of 1964) for a project for the 
construction of an experimental or demonstration facility 
having as its specific purpose the application of novel means 
for the reduction of hospital costs with respect to which there 
has been a substantial increase in the cost of such 
construction (over the estimated cost of such project on the 
basis of which such grant was made) through no fault of such 
recipient, the Secretary is authorized to make a loan to such 
recipient not exceeding 66\2/3\ per centum of such increased 
costs, as determined by the Secretary, if the Secretary 
determines that such recipient is unable to obtain such an 
amount for such purpose from other public or private sources.
    (b) Any such loan shall be made only on the basis of an 
application submitted to the Secretary in such form and 
containing such information and assurances as he may prescribe.
    (c) Each such loan shall bear interest at the rate of 2\1/
2\ per centum per annum on the unpaid balance thereof and shall 
be repayable over a period determined by the Secretary to be 
appropriate, but not exceeding fifty years.
    (d) There are hereby authorized to be appropriated 
$3,500,000 to carry out the provisions of this section.

                              definitions

    Sec. 645. \1\ [291o] For the purposes of this title--
---------------------------------------------------------------------------
    \1\ Section 644 was repealed by section 3(b) of Public Law 90-174.
---------------------------------------------------------------------------
    (a) The term ``State'' includes the Commonwealth of Puerto 
Rico, Guam, American Samoa, the Trust Territory of the Pacific 
Islands, the Virgin Islands, and the District of Columbia.
    (b)(1) The term ``Federal share'' with respect to any 
project means the proportion of the cost of such project to be 
paid by the Federal Government under this title.
    (2) With respect to any project in any State for which a 
grant is made from an allotment from an appropriation under 
section 601, the Federal share shall be the amount determined 
by the State agency designated in accordance with section 604, 
but not more than 66\2/3\ per centum or the State's allotment 
percentage, whichever is the lower, except that, if the State's 
allotment percentage is lower than 50 per centum, such 
allotment percentage shall be deemed to be 50 per centum for 
purposes of this paragraph.
    (3) Prior to the approval of the first project in a State 
during any fiscal year the State agency designated in 
accordance with section 604 shall give the Secretary written 
notification of the maximum Federal share established pursuant 
to paragraph (2) for projects in such State to be approved by 
the Secretary during such fiscal year and the method for 
determining the actual Federal share to be paid with respect to 
such projects; and such maximum Federal share and such method 
of determination for projects in such State approved during 
such fiscal year shall not be changed after such approval.
    (4) Notwithstanding the provisions of paragraphs (2) and 
(3) of this subsection, the Federal share shall, at the option 
of the State agency, be equal to the per centum provided under 
such paragraphs plus an incentive per centum (which when 
combined with the per centum provided under such paragraphs 
shall not exceed 90 per centum) specified by the State agency 
in the case of (A) projects that will provide services 
primarily for persons in an area determined by the Secretary to 
be a rural or urban poverty area, and (B) projects that offer 
potential for reducing health care costs through shared 
services among health care facilities, through interfacility 
cooperation, or through the construction or modernization of 
free-standing outpatient facilities.
    (c) The term ``hospital'' includes general, tuberculosis, 
and other types of hospitals, and related facilities, such as 
laboratories, outpatient departments, nurses' home facilities, 
extended care facilities, facilities related to programs for 
home health services, self-care units, and central service 
facilities, operated in connection with hospitals, and also 
includes education or training facilities for health 
professions personnel operated as an integral part of a 
hospital, but does not include any hospital furnishing 
primarily domiciliary care.
    (d) The term ``public health center'' means a publicly 
owned facility for the provision of public health services, 
including related publicly owned facilities such as 
laboratories, clinics, and administrative offices operated in 
connection with such a facility.
    (e) The term ``nonprofit'' as applied to any facility means 
a facility which is owned and operated by one or more nonprofit 
corporations or associations no part of the net earnings of 
which inures, or may lawfully inure, to the benefit of any 
private shareholder or individual.
    (f) The term ``outpatient facility'' means a facility 
(located in or apart from a hospital) for the diagnosis or 
diagnosis and treatment of ambulatory patients (including 
ambulatory inpatients)--
            (1) which is operated in connection with a 
        hospital, or
            (2) in which patient care is under the professional 
        supervision of persons licensed to practice medicine or 
        surgery in the State, or in the case of dental 
        diagnosis or treatment, under the professional 
        supervision of persons licensed to practice dentistry 
        in the State; or
            (3) which offers to patients not requiring 
        hospitalization the services of licensed physicians in 
        various medical specialties, and which provides to its 
        patients a reasonably full-range of diagnostic and 
        treatment services.
    (g) The term ``rehabilitation facility'' means a facility 
which is operated for the primary purpose of assisting in the 
rehabilitation of disabled persons through an integrated 
program of--
            (1) medical evaluation and services, and
            (2) psychological, social, or vocational evaluation 
        and services,
under competent professional supervision, and in the case of 
which--
            (3) the major portion of the required evaluation 
        and services is furnished within the facility; and
            (4) either (A) the facility is operated in 
        connection with a hospital, or (B) all medical and 
        related health services are prescribed by, or are under 
        the general direction of, persons licensed to practice 
        medicine or surgery in the State.
    (h) The term ``facility for long-term care'' means a 
facility (including an extended care facility) providing in-
patient care for convalescent or chronic disease patients who 
require skilled nursing care and related medical services--
            (1) which is a hospital (other than a hospital 
        primarily for the care and treatment of mentally ill or 
        tuberculous patients) or is operated in connection with 
        a hospital, or
            (2) in which such nursing care and medical services 
        are prescribed by, or are performed under the general 
        direction of, persons licensed to practice medicine or 
        surgery in the State.
    (i) The term ``construction'' includes construction of new 
buildings, expansion, remodeling, and alteration of existing 
buildings, and initial equipment of any such buildings 
(including medical transportation facilities) and, in any case 
in which it will help to provide a service not previously 
provided in the community, equipment of any buildings; 
including architects' fees, but excluding the cost of off-site 
improvements and, except with respect to public health centers, 
the cost of the acquisition of land.
    (j) The term ``cost'' as applied to construction or 
modernization means the amount found by the Surgeon General to 
be necessary for construction and modernization respectively, 
under a project, except that such term, as applied to a project 
for modernization of a facility for which a grant or loan is to 
be made from an allotment under section 602(a)(2), does not 
include any amount found by the Surgeon General to be 
attributable to expansion of the bed capacity of such facility.
    (k) The term ``modernization'' includes alteration, major 
repair (to the extent permitted by regulations), remodeling, 
replacement, and renovation of existing buildings (including 
initial equipment thereof), and replacement of obsolete, built-
in (as determined in accordance with regulations) equipment of 
existing buildings.
    (l) The term ``title,'' when used with reference to a site 
for a project, means a fee simple, or such other estate or 
interest (including a leasehold on which the rental does not 
exceed 4 per centum of the value of the land) as the Surgeon 
General finds sufficient to assure for a period of not less 
than fifty years' undisturbed use and possession for the 
purposes of construction and operation of the 
project.* deg.

                          financial statements

    Sec. 646. [291o-1] In the case of any facility for which a 
grant, loan, or loan guarantee has been made under this title, 
the applicant for such grant, loan, or loan guarantee (or, if 
appropriate, such other person as the Secretary may prescribe) 
shall file at least annually with the State agency for the 
State in which the facility is located a statement which shall 
be in such form, and contain such information, as the Secretary 
may require to accurately show--
            (1) the financial operations of the facility, and
            (2) the costs to the facility of providing health 
        services in the facility and the charges made by the 
        facility for providing such services,
during the period with respect to which the statement is 
filed.ATTORNEY: PMG/FD (June 3, 1999) deg.
                TITLE VII--HEALTH PROFESSIONS EDUCATION

                         PART A--STUDENT LOANS

   Subpart I--Insured Health Education Assistance Loans to Graduate 
                                Students

SEC. 701. [292] STATEMENT OF PURPOSE.

    The purpose of this subpart is to enable the Secretary to 
provide a Federal program of student loan insurance for 
students in (and certain former students of) eligible 
institutions (as defined in section 719).

SEC. 702. [292A] SCOPE AND DURATION OF LOAN INSURANCE PROGRAM.

    (a) In General.--The total principal amount of new loans 
made and installments paid pursuant to lines of credit (as 
defined in section 719) to borrowers covered by Federal loan 
insurance under this subpart shall not exceed $350,000,000 for 
fiscal year 1993, $375,000,000 for fiscal year 1994, and 
$425,000,000 for fiscal year 1995. If the total amount of new 
loans made and installments paid pursuant to lines of credit in 
any fiscal year is less than the ceiling established for such 
year, the difference between the loans made and installments 
paid and the ceiling shall be carried over to the next fiscal 
year and added to the ceiling applicable to that fiscal year, 
and if in any fiscal year no ceiling has been established, any 
difference carried over shall constitute the ceiling for making 
new loans (including loans to new borrowers) and paying 
installments for such fiscal year. Thereafter, Federal loan 
insurance pursuant to this subpart may be granted only for 
loans made (or for loan installments paid pursuant to lines of 
credit) to enable students, who have obtained prior loans 
insured under this subpart, to continue or complete their 
educational program or to obtain a loan under section 
705(a)(1)(B) to pay interest on such prior loans; but no 
insurance may be granted for any loan made or installment paid 
after September 30, 1998. The total principal amount of Federal 
loan insurance available under this subsection shall be granted 
by the Secretary without regard to any apportionment for the 
purpose of chapter 15 of title 31, United States Code, and 
without regard to any similar limitation.
    (b) Certain Limitations and Priorities.--
            (1) Limitations regarding lenders, states, or 
        areas.--The Secretary may, if necessary to assure an 
        equitable distribution of the benefits of this subpart, 
        assign, within the maximum amounts specified in 
        subsection (a), Federal loan insurance quotas 
        applicable to eligible lenders, or to States or areas, 
        and may from time to time reassign unused portions of 
        these quotas.
            (2) Priority for certain lenders.--In providing 
        certificates of insurance under section 706 through 
        comprehensive contracts, the Secretary shall give 
        priority to eligible lenders that agree--
                    (A) to make loans to students at interest 
                rates below the rates prevailing, during the 
                period involved, for loans covered by Federal 
                loan insurance pursuant to this subpart; or
                    (B) to make such loans under terms that are 
                otherwise favorable to the student relative to 
                the terms under which eligible lenders are 
                generally making such loans during such period.
    (c) Authority of Student Loan Marketing Association.--
            (1) In general.--Subject to paragraph (2), the 
        Student Loan Marketing Association, established under 
        part B of title IV of the Higher Education Act of 1965, 
        is authorized to make advances on the security of, 
        purchase, service, sell, consolidate, or otherwise deal 
        in loans which are insured by the Secretary under this 
        subpart, except that if any loan made under this 
        subpart is included in a consolidated loan pursuant to 
        the authority of the Association under part B of title 
        IV of the Higher Education Act of 1965, the interest 
        rate on such consolidated loan shall be set at the 
        weighted average interest rate of all such loans 
        offered for consolidation and the resultant per centum 
        shall be rounded downward to the nearest one-eighth of 
        1 per centum, except that the interest rate shall be no 
        less than the applicable interest rate of the 
        guaranteed student loan program established under part 
        B of title IV of the Higher Education Act of 1965. In 
        the case of such a consolidated loan, the borrower 
        shall be responsible for any interest which accrues 
        prior to the beginning of the repayment period of the 
        loan, or which accrues during a period in which 
        principal need not be paid (whether or not such 
        principal is in fact paid) by reason of any provision 
        of the Higher Education Act of 1965.
            (2) Applicability of certain federal regulations.--
        With respect to Federal regulations for lenders, this 
        subpart may not be construed to preclude the 
        applicability of such regulations to the Student Loan 
        Marketing Association or to any other entity in the 
        business of purchasing student loans, including such 
        regulations with respect to applications, contracts, 
        and due diligence.

SEC. 703. [292B] LIMITATIONS ON INDIVIDUAL INSURED LOANS AND ON LOAN 
                    INSURANCE.

    (a) In General.--The total of the loans made to a student 
in any academic year or its equivalent (as determined by the 
Secretary) which may be covered by Federal loan insurance under 
this subpart may not exceed $20,000 in the case of a student 
enrolled in a school of medicine, osteopathic medicine, 
dentistry, veterinary medicine, optometry, or podiatric 
medicine, and $12,500 in the case of a student enrolled in a 
school of pharmacy, public health, allied health, or 
chiropractic, or a graduate program in health administration or 
behavioral and mental health practice, including clinical 
psychology. The aggregate insured unpaid principal amount for 
all such insured loans made to any borrower shall not at any 
time exceed $80,000 in the case of a borrower who is or was a 
student enrolled in a school of medicine, osteopathic medicine, 
dentistry, veterinary medicine, optometry, or podiatric 
medicine, and $50,000 in the case of a borrower who is or was a 
student enrolled in a school of pharmacy, public health, allied 
health, or chiropractic, or a graduate program in health 
administration or clinical psychology. The annual insurable 
limit per student shall not be exceeded by a line of credit 
under which actual payments by the lender to the borrower will 
not be made in any year in excess of the annual limit.
    (b) Extent of Insurance Liability.--The insurance liability 
on any loan insured by the Secretary under this subpart shall 
be 100 percent of the unpaid balance of the principal amount of 
the loan plus interest. The full faith and credit of the United 
States is pledged to the payment of all amounts which may be 
required to be paid under the provisions of section 707 or 714.

SEC. 704. [292C] SOURCES OF FUNDS.

    Loans made by eligible lenders in accordance with this 
subpart shall be insurable by the Secretary whether made from 
funds fully owned by the lender or from funds held by the 
lender in a trust or similar capacity and available for such 
loans.

SEC. 705. [292D] ELIGIBILITY OF BORROWERS AND TERMS OF INSURED LOANS.

    (a) In General.--A loan by an eligible lender shall be 
insurable by the Secretary under the provisions of this subpart 
only if--
            (1) made to--
                    (A) a student who--
                            (i)(I) has been accepted for 
                        enrollment at an eligible institution, 
                        or (II) in the case of a student 
                        attending an eligible institution, is 
                        in good standing at that institution, 
                        as determined by the institution;
                            (ii) is or will be a full-time 
                        student at the eligible institution;
                            (iii) has agreed that all funds 
                        received under such loan shall be used 
                        solely for tuition, other reasonable 
                        educational expenses, including fees, 
                        books, and laboratory expenses, and 
                        reasonable living expenses, incurred by 
                        such students;
                            (iv) if required under section 3 of 
                        the Military Selective Service Act to 
                        present himself for and submit to 
                        registration under such section, has 
                        presented himself and submitted to 
                        registration under such section; and
                            (v) in the case of a pharmacy 
                        student, has satisfactorily completed 
                        three years of training; or
                    (B) an individual who--
                            (i) has previously had a loan 
                        insured under this subpart when the 
                        individual was a full-time student at 
                        an eligible institution;
                            (ii) is in a period during which, 
                        pursuant to paragraph (2), the 
                        principal amount of such previous loan 
                        need not be paid;
                            (iii) has agreed that all funds 
                        received under the proposed loan shall 
                        be used solely for repayment of 
                        interest due on previous loans made 
                        under this subpart; and
                            (iv) if required under section 3 of 
                        the Military Selective Service Act to 
                        present himself for and submit to 
                        registration under such section, has 
                        presented himself and submitted to 
                        registration under such section;
            (2) evidenced by a note or other written agreement 
        which--
                    (A) is made without security and without 
                endorsement, except that if the borrower is a 
                minor and such note or other written agreement 
                executed by him would not, under the applicable 
                law, create a binding obligation, an 
                endorsement may be required;
                    (B) provides for repayment of the principal 
                amount of the loan in installments over a 
                period of not less than 10 years (unless sooner 
                repaid) nor more than 25 years beginning not 
                earlier than 9 months nor later than 12 months 
                after the date of--
                            (i) the date on which--
                                    (I) the borrower ceases to 
                                be a participant in an 
                                accredited internship or 
                                residency program of not more 
                                than four years in duration;
                                    (II) the borrower completes 
                                the fourth year of an 
                                accredited internship or 
                                residency program of more than 
                                four years in duration; or
                                    (III) the borrower, if not 
                                a participant in a program 
                                described in subclause (I) or 
                                (II), ceases to carry, at an 
                                eligible institution, the 
                                normal full-time academic 
                                workload as determined by the 
                                institution; or
                            (ii) the date on which a borrower 
                        who is a graduate of an eligible 
                        institution ceases to be a participant 
                        in a fellowship training program not in 
                        excess of two years or a participant in 
                        a full-time educational activity not in 
                        excess of two years, which--
                                    (I) is directly related to 
                                the health profession for which 
                                the borrower prepared at an 
                                eligible institution, as 
                                determined by the Secretary; 
                                and
                                    (II) may be engaged in by 
                                the borrower during such a two-
                                year period which begins within 
                                twelve months after the 
                                completion of the borrower's 
                                participation in a program 
                                described in subclause (I) or 
                                (II) of clause (i) or prior to 
                                the completion of the 
                                borrower's participation in 
                                such program,
                except as provided in subparagraph (C), except 
                that the period of the loan may not exceed 33 
                years from the date of execution of the note or 
                written agreement evidencing it, and except 
                that the note or other written instrument may 
                contain such provisions relating to repayment 
                in the event of default in the payment of 
                interest or in the payment of the costs of 
                insurance premiums, or other default by the 
                borrower, as may be authorized by regulations 
                of the Secretary in effect at the time the loan 
                is made;
                    (C) provides that periodic installments of 
                principal and interest need not be paid, but 
                interest shall accrue, during any period (i) 
                during which the borrower is pursuing a full-
                time course of study at an eligible institution 
                (or at an institution defined by section 102(a) 
                of the Higher Education Act of 1965); (ii) not 
                in excess of four years during which the 
                borrower is a participant in an accredited 
                internship or residency program (including any 
                period in such a program described in subclause 
                (I) or subclause (II) of subparagraph (B)(i)); 
                (iii) not in excess of three years, during 
                which the borrower is a member of the Armed 
                Forces of the United States; (iv) not in excess 
                of three years during which the borrower is in 
                service as a volunteer under the Peace Corps 
                Act; (v) not in excess of three years during 
                which the borrower is a member of the National 
                Health Service Corps; (vi) not in excess of 
                three years during which the borrower is in 
                service as a full-time volunteer under title I 
                of the Domestic Volunteer Service Act of 1973; 
                (vii) not in excess of 3 years, for a borrower 
                who has completed an accredited internship or 
                residency training program in osteopathic 
                general practice, family medicine, general 
                internal medicine, preventive medicine, or 
                general pediatrics and who is practicing 
                primary care; (viii) not in excess of 1 year, 
                for borrowers who are graduates of schools of 
                chiropractic; (ix) any period not in excess of 
                two years which is described in subparagraph 
                (B)(ii); (x) not in excess of three years, 
                during which the borrower is providing health 
                care services to Indians through an Indian 
                health program (as defined in section 
                108(a)(2)(A) of the Indian Health Care 
                Improvement Act (25 U.S.C. 1616a(a)(2)(A)) \1\; 
                and (xi) in addition to all other deferments 
                for which the borrower is eligible under 
                clauses (i) through (x), any period during 
                which the borrower is a member of the Armed 
                Forces on active duty during the Persian Gulf 
                conflict, and any period described in clauses 
                (i) through (xi) shall not be included in 
                determining the 25-year period described in 
                subparagraph (B);
---------------------------------------------------------------------------
    \1\ So in law. Probably should include another closing parenthesis.
---------------------------------------------------------------------------
                    (D) provides for interest on the unpaid 
                principal balance of the loan at a yearly rate, 
                not exceeding the applicable maximum rate 
                prescribed and defined by the Secretary (within 
                the limits set forth in subsection (b)) on a 
                national, regional, or other appropriate basis, 
                which interest shall be compounded not more 
                frequently than annually and payable in 
                installments over the period of the loan except 
                as provided in subparagraph (C), except that 
                the note or other written agreement may provide 
                that payment of any interest may be deferred 
                until not later than the date upon which 
                repayment of the first installment of principal 
                falls due or the date repayment of principal is 
                required to resume (whichever is applicable) 
                and may further provide that, on such date, the 
                amount of the interest which has so accrued may 
                be added to the principal for the purposes of 
                calculating a repayment schedule;
                    (E) offers, in accordance with criteria 
                prescribed by regulation by the Secretary, a 
                schedule for repayment of principal and 
                interest under which payment of a portion of 
                the principal and interest otherwise payable at 
                the beginning of the repayment period (as 
                defined in such regulations) is deferred until 
                a later time in the period;
                    (F) entitles the borrower to accelerate 
                without penalty repayment of the whole or any 
                part of the loan;
                    (G) provides that the check for the 
                proceeds of the loan shall be made payable 
                jointly to the borrower and the eligible 
                institution in which the borrower is enrolled; 
                and
                    (H) contains such other terms and 
                conditions consistent with the provisions of 
                this subpart and with the regulations issued by 
                the Secretary pursuant to this subpart, as may 
                be agreed upon by the parties to such loan, 
                including, if agreed upon, a provision 
                requiring the borrower to pay to the lender, in 
                addition to principal and interest, amounts 
                equal to the insurance premiums payable by the 
                lender to the Secretary with respect to such 
                loan; and
            (3) subject to the consent of the student and 
        subject to applicable law, the eligible lender has 
        obtained from the student appropriate demographic 
        information regarding the student, including racial or 
        ethnic background.
    (b) Limitation on Rate of Interest.--The rate of interest 
prescribed and defined by the Secretary for the purpose of 
subsection (a)(2)(D) may not exceed the average of the bond 
equivalent rates of the 91-day Treasury bills auctioned for the 
previous quarter plus 3 percentage points, rounded to the next 
higher one-eighth of 1 percent.
    (c) Minimum Annual Payment by Borrower.--The total of the 
payments by a borrower during any year or any repayment period 
with respect to the aggregate amount of all loans to that 
borrower which are insured under this subpart shall not be less 
than the annual interest on the outstanding principal, except 
as provided in subsection (a)(2)(C), unless the borrower, in 
the written agreement described in subsection (a)(2), agrees to 
make payments during any year or any repayment period in a 
lesser amount.
    (d) Applicability of Certain Laws on Rate or Amount of 
Interest.--No provision of any law of the United States (other 
than subsections (a)(2)(D) and (b)) or of any State that limits 
the rate or amount of interest payable on loans shall apply to 
a loan insured under this subpart.
    (e) Determination Regarding Forbearance.--Any period of 
time granted to a borrower under this subpart in the form of 
forbearance on the loan shall not be included in the 25-year 
total loan repayment period under subsection (a)(2)(C).
    (f) Loan Repayment Schedule.--Lenders and holders under 
this subpart shall offer borrowers graduated loan repayment 
schedules that, during the first 5 years of loan repayment, are 
based on the borrower's debt-to-income ratio.
    (g) Rule of Construction Regarding Determination of Need of 
Students.--With respect to any determination of the financial 
need of a student for a loan covered by Federal loan insurance 
under this subpart, this subpart may not be construed to limit 
the authority of any school to make such allowances for 
students with special circumstances as the school determines 
appropriate.
    (h) Definitions.--For purposes of this section:
            (1) The term ``active duty'' has the meaning given 
        such term in section 101(18) of title 37, United States 
        Code, except that such term does not include active 
        duty for training.
            (2) The term ``Persian Gulf conflict'' means the 
        period beginning on August 2, 1990, and ending on the 
        date thereafter prescribed by Presidential proclamation 
        or by law.

SEC. 706. [292E] CERTIFICATE OF LOAN INSURANCE; EFFECTIVE DATE OF 
                    INSURANCE.

    (a) In General.--
            (1) Authority for issuance of certificate.--If, 
        upon application by an eligible lender, made upon such 
        form, containing such information, and supported by 
        such evidence as the Secretary may require, and 
        otherwise in conformity with this section, the 
        Secretary finds that the applicant has made a loan to 
        an eligible borrower which is insurable under the 
        provisions of this subpart, he may issue to the 
        applicant a certificate of insurance covering the loan 
        and setting forth the amount and terms of the 
        insurance.
            (2) Effective date of insurance.--Insurance 
        evidenced by a certificate of insurance pursuant to 
        subsection (a)(1) shall become effective upon the date 
        of issuance of the certificate, except that the 
        Secretary is authorized, in accordance with 
        regulations, to issue commitments with respect to 
        proposed loans, or with respect to lines (or proposed 
        lines) of credit, submitted by eligible lenders, and in 
        that event, upon compliance with subsection (a)(1) by 
        the lender, the certificate of insurance may be issued 
        effective as of the date when any loan, or any payment 
        by the lender pursuant to a line of credit, to be 
        covered by such insurance is made to a student 
        described in section 705(a)(1). Such insurance shall 
        cease to be effective upon 60 days' default by the 
        lender in the payment of any installment of the 
        premiums payable pursuant to section 708.
            (3) Certain agreements for lenders.--An application 
        submitted pursuant to subsection (a)(1) shall contain--
                    (A) an agreement by the applicant to pay, 
                in accordance with regulations, the premiums 
                fixed by the Secretary pursuant to section 708; 
                and
                    (B) an agreement by the applicant that if 
                the loan is covered by insurance the applicant 
                will submit such supplementary reports and 
                statements during the effective period of the 
                loan agreement, upon such forms, at such times, 
                and containing such information as the 
                Secretary may prescribe by or pursuant to 
                regulation.
    (b) Authority Regarding Comprehensive Insurance Coverage.--
            (1) In general.--In lieu of requiring a separate 
        insurance application and issuing a separate 
        certificate of insurance for each loan made by an 
        eligible lender as provided in subsection (a), the 
        Secretary may, in accordance with regulations 
        consistent with section 702, issue to any eligible 
        lender applying therefor a certificate of comprehensive 
        insurance coverage which shall, without further action 
        by the Secretary, insure all insurable loans made by 
        that lender, on or after the date of the certificate 
        and before a specified cutoff date, within the limits 
        of an aggregate maximum amount stated in the 
        certificate. Such regulations may provide for 
        conditioning such insurance, with respect to any loan, 
        upon compliance by the lender with such requirements 
        (to be stated or incorporated by reference in the 
        certificate) as in the Secretary's judgment will best 
        achieve the purpose of this subsection while protecting 
        the financial interest of the United States and 
        promoting the objectives of this subpart, including 
        (but not limited to) provisions as to the reporting of 
        such loans and information relevant thereto to the 
        Secretary and as to the payment of initial and other 
        premiums and the effect of default therein, and 
        including provision for confirmation by the Secretary 
        from time to time (through endorsement of the 
        certificate) of the coverage of specific new loans by 
        such certificate, which confirmation shall be 
        incontestable by the Secretary in the absence of fraud 
        or misrepresentation of fact or patent error.
            (2) Lines of credit beyond cutoff date.--If the 
        holder of a certificate of comprehensive insurance 
        coverage issued under this subsection grants to a 
        borrower a line of credit extending beyond the cutoff 
        date specified in that certificate, loans or payments 
        thereon made by the holder after that date pursuant to 
        the line of credit shall not be deemed to be included 
        in the coverage of that certificate except as may be 
        specifically provided therein; but, subject to the 
        limitations of section 702, the Secretary may, in 
        accordance with regulations, make commitments to insure 
        such future loans or payments, and such commitments may 
        be honored either as provided in subsection (a) or by 
        inclusion of such insurance in comprehensive coverage 
        under this subsection for the period or periods in 
        which such future loans or payments are made.
    (c) Assignment of Insurance Rights.--The rights of an 
eligible lender arising under insurance evidenced by a 
certificate of insurance issued to it under this section may be 
assigned by such lender, subject to regulation by the 
Secretary, only to--
            (1) another eligible lender (including a public 
        entity in the business of purchasing student loans); or
            (2) the Student Loan Marketing Association.
    (d) Effect of Refinancing or Consolidation of 
Obligations.--The consolidation of the obligations of two or 
more federally insured loans obtained by a borrower in any 
fiscal year into a single obligation evidenced by a single 
instrument of indebtedness or the refinancing of a single loan 
shall not affect the insurance by the United States. If the 
loans thus consolidated are covered by separate certificates of 
insurance issued under subsection (a), the Secretary may upon 
surrender of the original certificates issue a new certificate 
of insurance in accordance with that subsection upon the 
consolidated obligation. If the loans thus consolidated are 
covered by a single comprehensive certificate issued under 
subsection (b), the Secretary may amend that certificate 
accordingly.
    (e) Rule of Construction Regarding Consolidation of Debts 
and Refinancing.--Nothing in this section shall be construed to 
preclude the lender and the borrower, by mutual agreement, from 
consolidating all of the borrower's loans insured under this 
subpart into a single instrument (or, if the borrower obtained 
only 1 loan insured under this subpart, refinancing the loan 1 
time) under the terms applicable to an insured loan made at the 
same time as the consolidation. The lender or loan holder 
should provide full information to the borrower concerning the 
advantages and disadvantages of loan consolidation or 
refinancing. Nothing in this section shall be construed to 
preclude the consolidation of the borrower's loans insured 
under this subpart under section 428C of the Higher Education 
Act of 1965. Any loans insured pursuant to this subpart that 
are consolidated under section 428C of such Act shall not be 
eligible for special allowance payments under section 438 of 
such Act.

SEC. 707. [292F] DEFAULT OF BORROWER.

    (a) Conditions for Payment to Beneficiary.--
            (1) In general.--Upon default by the borrower on 
        any loan covered by Federal loan insurance pursuant to 
        this subpart, and after a substantial collection effort 
        (including, subject to subsection (h), commencement and 
        prosecution of an action) as determined under 
        regulations of the Secretary, the insurance beneficiary 
        shall promptly notify the Secretary and the Secretary 
        shall, if requested (at that time or after further 
        collection efforts) by the beneficiary, or may on his 
        own motion, if the insurance is still in effect, pay to 
        the beneficiary the amount of the loss sustained by the 
        insured upon that loan as soon as that amount has been 
        determined, except that, if the insurance beneficiary 
        including any servicer of the loan is not designated 
        for ``exceptional performance'', as set forth in 
        paragraph (2), the Secretary shall pay to the 
        beneficiary a sum equal to 98 percent of the amount of 
        the loss sustained by the insured upon that loan.
            (2) Exceptional performance.--
                    (A) Authority.--Where the Secretary 
                determines that an eligible lender, holder, or 
                servicer has a compliance performance rating 
                that equals or exceeds 97 percent, the 
                Secretary shall designate that eligible lender, 
                holder, or servicer, as the case may be, for 
                exceptional performance.
                    (B) Compliance performance rating.--For 
                purposes of subparagraph (A), a compliance 
                performance rating is determined with respect 
                to compliance with due diligence in the 
                disbursement, servicing, and collection of 
                loans under this subpart for each year for 
                which the determination is made. Such rating 
                shall be equal to the percentage of all due 
                diligence requirements applicable to each loan, 
                on average, as established by the Secretary, 
                with respect to loans serviced during the 
                period by the eligible lender, holder, or 
                servicer.
                    (C) Annual audits for lenders, holders, and 
                servicers.--Each eligible lender, holder, or 
                servicer desiring a designation under 
                subparagraph (A) shall have an annual financial 
                and compliance audit conducted with respect to 
                the loan portfolio of such eligible lender, 
                holder, or servicer, by a qualified independent 
                organization from a list of qualified 
                organizations identified by the Secretary and 
                in accordance with standards established by the 
                Secretary. The standards shall measure the 
                lender's, holder's, or servicer's compliance 
                with due diligence standards and shall include 
                a defined statistical sampling technique 
                designed to measure the performance rating of 
                the eligible lender, holder, or servicer for 
                the purpose of this section. Each eligible 
                lender, holder, or servicer shall submit the 
                audit required by this section to the 
                Secretary.
                    (D) Secretary's determinations.--The 
                Secretary shall make the determination under 
                subparagraph (A) based upon the audits 
                submitted under this paragraph and any 
                information in the possession of the Secretary 
                or submitted by any other agency or office of 
                the Federal Government.
                    (E) Quarterly compliance audit.--To 
                maintain its status as an exceptional 
                performer, the lender, holder, or servicer 
                shall undergo a quarterly compliance audit at 
                the end of each quarter (other than the quarter 
                in which status as an exceptional performer is 
                established through a financial and compliance 
                audit, as described in subparagraph (C)), and 
                submit the results of such audit to the 
                Secretary. The compliance audit shall review 
                compliance with due diligence requirements for 
                the period beginning on the day after the 
                ending date of the previous audit, in 
                accordance with standards determined by the 
                Secretary.
                    (F) Revocation authority.--The Secretary 
                shall revoke the designation of a lender, 
                holder, or servicer under subparagraph (A) if 
                any quarterly audit required under subparagraph 
                (E) is not received by the Secretary by the 
                date established by the Secretary or if the 
                audit indicates the lender, holder, or servicer 
                has failed to meet the standards for 
                designation as an exceptional performer under 
                subparagraph (A). A lender, holder, or servicer 
                receiving a compliance audit not meeting the 
                standard for designation as an exceptional 
                performer may reapply for designation under 
                subparagraph (A) at any time.
                    (G) Documentation.--Nothing in this section 
                shall restrict or limit the authority of the 
                Secretary to require the submission of claims 
                documentation evidencing servicing performed on 
                loans, except that the Secretary may not 
                require exceptional performers to submit 
                greater documentation than that required for 
                lenders, holders, and servicers not designated 
                under subparagraph (A).
                    (H) Cost of audits.--Each eligible lender, 
                holder, or servicer shall pay for all the costs 
                associated with the audits required under this 
                section.
                    (I) Additional revocation authority.--
                Notwithstanding any other provision of this 
                section, a designation under subparagraph (A) 
                may be revoked at any time by the Secretary if 
                the Secretary determines that the eligible 
                lender, holder, or servicer has failed to 
                maintain an overall level of compliance 
                consistent with the audit submitted by the 
                eligible lender, holder, or servicer under this 
                paragraph or if the Secretary asserts that the 
                lender, holder, or servicer may have engaged in 
                fraud in securing designation under 
                subparagraph (A) or is failing to service loans 
                in accordance with program requirements.
                    (J) Noncompliance.--A lender, holder, or 
                servicer designated under subparagraph (A) that 
                fails to service loans or otherwise comply with 
                applicable program regulations shall be 
                considered in violation of the Federal False 
                Claims Act.
    (b) Subrogation.--Upon payment by the Secretary of the 
amount of the loss pursuant to subsection (a), the United 
States shall be subrogated for all of the rights of the holder 
of the obligation upon the insured loan and shall be entitled 
to an assignment of the note or other evidence of the insured 
loan by the insurance beneficiary. If the net recovery made by 
the Secretary on a loan after deduction of the cost of that 
recovery (including reasonable administrative costs) exceeds 
the amount of the loss, the excess shall be paid over to the 
insured. The Secretary may sell without recourse to eligible 
lenders (or other entities that the Secretary determines are 
capable of dealing in such loans) notes or other evidence of 
loans received through assignment under the first sentence.
    (c) Forbearance.--Nothing in this section or in this 
subpart shall be construed to preclude any forbearance for the 
benefit of the borrower which may be agreed upon by the parties 
to the insured loan and approved by the Secretary or to 
preclude forbearance by the Secretary in the enforcement of the 
insured obligation after payment on that insurance.
    (d) Reasonable Care and Diligence Regarding Loans.--Nothing 
in this section or in this subpart shall be construed to excuse 
the eligible lender or holder of a federally insured loan from 
exercising reasonable care and diligence in the making of loans 
under the provisions of this subpart and from exercising a 
substantial effort in the collection of loans under the 
provisions of this subpart. If the Secretary, after reasonable 
notice and opportunity for hearing to an eligible lender, finds 
that the lender has failed to exercise such care and diligence, 
to exercise such substantial efforts, to make the reports and 
statements required under section 706(a)(3), or to pay the 
required Federal loan insurance premiums, he shall disqualify 
that lender from obtaining further Federal insurance on loans 
granted pursuant to this subpart until he is satisfied that its 
failure has ceased and finds that there is reasonable assurance 
that the lender will in the future exercise necessary care and 
diligence, exercise substantial effort, or comply with such 
requirements, as the case may be.
    (e) Definitions.--For purposes of this section:
            (1) The term ``insurance beneficiary'' means the 
        insured or its authorized assignee in accordance with 
        section 706(c).
            (2) The term ``amount of the loss'' means, with 
        respect to a loan, unpaid balance of the principal 
        amount and interest on such loan, less the amount of 
        any judgment collected pursuant to default proceedings 
        commenced by the eligible lender or holder involved.
            (3) The term ``default'' includes only such 
        defaults as have existed for 120 days.
            (4) The term ``servicer'' means any agency acting 
        on behalf of the insurance beneficiary.
    (f) Reductions in Federal Reimbursements or Payments for 
Defaulting Borrowers.--The Secretary shall, after notice and 
opportunity for a hearing, cause to be reduced Federal 
reimbursements or payments for health services under any 
Federal law to borrowers who are practicing their professions 
and have defaulted on their loans insured under this subpart in 
amounts up to the remaining balance of such loans. Procedures 
for reduction of payments under the medicare program are 
provided under section 1892 of the Social Security Act. 
Notwithstanding such section 1892, any funds recovered under 
this subsection shall be deposited in the insurance fund 
established under section 710.
    (g) Conditions for Discharge of Debt in Bankruptcy.--
Notwithstanding any other provision of Federal or State law, a 
debt that is a loan insured under the authority of this subpart 
may be released by a discharge in bankruptcy under any chapter 
of title 11, United States Code, only if such discharge is 
granted--
            (1) after the expiration of the seven-year period 
        beginning on the first date when repayment of such loan 
        is required, exclusive of any period after such date in 
        which the obligation to pay installments on the loan is 
        suspended;
            (2) upon a finding by the Bankruptcy Court that the 
        nondischarge of such debt would be unconscionable; and
            (3) upon the condition that the Secretary shall not 
        have waived the Secretary's rights to apply subsection 
        (f) to the borrower and the discharged debt.
    (h) Requirement Regarding Actions for Default.--
            (1) In general.--With respect to the default by a 
        borrower on any loan covered by Federal loan insurance 
        under this subpart, the Secretary shall, under 
        subsection (a), require an eligible lender or holder to 
        commence and prosecute an action for such default 
        unless--
                    (A) in the determination of the Secretary--
                            (i) the eligible lender or holder 
                        has made reasonable efforts to serve 
                        process on the borrower involved and 
                        has been unsuccessful with respect to 
                        such efforts, or
                            (ii) prosecution of such an action 
                        would be fruitless because of the 
                        financial or other circumstances of the 
                        borrower;
                    (B) for such loans made before the date of 
                the enactment of the Health Professions 
                Reauthorization Act of 1988, the loan involved 
                was made in an amount of less than $5,000; or
                    (C) for such loans made after such date, 
                the loan involved was made in an amount of less 
                than $2,500.
            (2) Relationship to claim for payment.--With 
        respect to an eligible lender or holder that has 
        commenced an action pursuant to subsection (a), the 
        Secretary shall make the payment required in such 
        subsection, or deny the claim for such payment, not 
        later than 60 days after the date on which the 
        Secretary determines that the lender or holder has made 
        reasonable efforts to secure a judgment and collect on 
        the judgment entered into pursuant to this subsection.
            (3) State court judgments.--With respect to any 
        State court judgment that is obtained by a lender or 
        holder against a borrower for default on a loan insured 
        under this subpart and that is subrogated to the United 
        States under subsection (b), any United States attorney 
        may register such judgment with the Federal courts for 
        enforcement.
    (i) Inapplicability of Federal and State Statute of 
Limitations on Actions for Loan Collection.--Notwithstanding 
any other provision of Federal or State law, there shall be no 
limitation on the period within which suit may be filed, a 
judgment may be enforced, or an offset, garnishment, or other 
action may be initiated or taken by the Secretary, the Attorney 
General, or other administrative head of another Federal 
agency, as the case may be, for the repayment of the amount due 
from a borrower on a loan made under this subpart that has been 
assigned to the Secretary under subsection (b).
    (j) School Collection Assistance.--An institution or 
postgraduate training program attended by a borrower may assist 
in the collection of any loan of that borrower made under this 
subpart which becomes delinquent, including providing 
information concerning the borrower to the Secretary and to 
past and present lenders and holders of the borrower's loans, 
contacting the borrower in order to encourage repayment, and 
withholding services in accordance with regulations issued by 
the Secretary under section 715(a)(7). The institution or 
postgraduate training program shall not be subject to section 
809 of the Fair Debt Collection Practices Act for purposes of 
carrying out activities authorized by this section.

SEC. 708. [292G] RISK-BASED PREMIUMS.

    (a) Authority.--With respect to a loan made under this 
subpart on or after January 1, 1993, the Secretary, in 
accordance with subsection (b), shall assess a risk-based 
premium on an eligible borrower and, if required under this 
section, an eligible institution that is based on the default 
rate of the eligible institution involved (as defined in 
section 719).
    (b) Assessment of Premium.--Except as provided in 
subsection (d)(2), the risk-based premium to be assessed under 
subsection (a) shall be as follows:
            (1) Low-risk rate.--With respect to an eligible 
        borrower seeking to obtain a loan for attendance at an 
        eligible institution that has a default rate of not to 
        exceed five percent, such borrower shall be assessed a 
        risk-based premium in an amount equal to 6 percent of 
        the principal amount of the loan.
            (2) Medium-risk rate.--
                    (A) In general.--With respect to an 
                eligible borrower seeking to obtain a loan for 
                attendance at an eligible institution that has 
                a default rate of in excess of five percent but 
                not to exceed 10 percent--
                            (i) such borrower shall be assessed 
                        a risk-based premium in an amount equal 
                        to 8 percent of the principal amount of 
                        the loan; and
                            (ii) such institution shall be 
                        assessed a risk-based premium in an 
                        amount equal to 5 percent of the 
                        principal amount of the loan.
                    (B) Default management plan.--An 
                institution of the type described in 
                subparagraph (A) shall prepare and submit to 
                the Secretary for approval, an annual default 
                management plan, that shall specify the 
                detailed short-term and long-term procedures 
                that such institution will have in place to 
                minimize defaults on loans to borrowers under 
                this subpart. Under such plan the institution 
                shall, among other measures, provide an exit 
                interview to all borrowers that includes 
                information concerning repayment schedules, 
                loan deferments, forbearance, and the 
                consequences of default.
            (3) High-risk rate.--
                    (A) In general.--With respect to an 
                eligible borrower seeking to obtain a loan for 
                attendance at an eligible institution that has 
                a default rate of in excess of 10 percent but 
                not to exceed 20 percent--
                            (i) such borrower shall be assessed 
                        a risk-based premium in an amount equal 
                        to 8 percent of the principal amount of 
                        the loan; and
                            (ii) such institution shall be 
                        assessed a risk-based premium in an 
                        amount equal to 10 percent of the 
                        principal amount of the loan.
                    (B) Default management plan.--An 
                institution of the type described in 
                subparagraph (A) shall prepare and submit to 
                the Secretary for approval a plan that meets 
                the requirements of paragraph (2)(B).
            (4) Ineligibility.--An individual shall not be 
        eligible to obtain a loan under this subpart for 
        attendance at an institution that has a default rate in 
        excess of 20 percent.
    (c) Reduction of Risk-Based Premium.--Lenders shall reduce 
by 50 percent the risk-based premium to eligible borrowers if a 
credit worthy parent or other responsible party co-signs the 
loan note.
    (d) Administrative Waivers.--
            (1) Hearing.--The Secretary shall afford an 
        institution not less than one hearing, and may consider 
        mitigating circumstances, prior to making such 
        institution ineligible for participation in the program 
        under this subpart.
            (2) Exceptions.--In carrying out this section with 
        respect to an institution, the Secretary may grant an 
        institution a waiver of requirements of paragraphs (2) 
        through (4) of subsection (b) if the Secretary 
        determines that the default rate for such institution 
        is not an accurate indicator because the volume of the 
        loans under this subpart made by such institution has 
        been insufficient.
            (3) Transition for certain institutions.--During 
        the 3-year period beginning on the effective date of 
        the Health Professions Education Extension Amendments 
        of 1992--
                    (A) subsection (b)(4) shall not apply with 
                respect to any eligible institution that is a 
                Historically Black College or University; and
                    (B) any such institution that has a default 
                rate in excess of 20 percent, and any eligible 
                borrower seeking a loan for attendance at the 
                institution, shall be subject to subsection 
                (b)(3) to the same extent and in the same 
                manner as eligible institutions and borrowers 
                described in such subsection.
    (e) Payoff To Reduce Risk Category.--An institution may pay 
off the outstanding principal and interest owed by the 
borrowers of such institution who have defaulted on loans made 
under this subpart in order to reduce the risk category of the 
institution.

SEC. 709. [292H] OFFICE FOR HEALTH EDUCATION ASSISTANCE LOAN DEFAULT 
                    REDUCTION.

    (a) Establishment.--The Secretary shall establish, within 
the Division of Student Assistance of the Bureau of Health 
Professions, an office to be known as the Office for Health 
Education Assistance Loan Default Reduction (in this section 
referred to as the ``Office'').
    (b) Purpose and Functions.--It shall be the purpose of the 
Office to achieve a reduction in the number and amounts of 
defaults on loans guaranteed under this subpart. In carrying 
out such purpose the Office shall--
            (1) conduct analytical and evaluative studies 
        concerning loans and loan defaults;
            (2) carry out activities designed to reduce loan 
        defaults;
            (3) respond to special circumstances that may exist 
        in the financial lending environment that may lead to 
        loan defaults;
            (4) coordinate with other Federal entities that are 
        involved with student loan programs, including--
                    (A) with respect to the Department of 
                Education, in the development of a single 
                student loan application form, a single student 
                loan deferment form, a single disability form, 
                and a central student loan database; and
                    (B) with respect to the Department of 
                Justice, in the recovery of payments from 
                health professionals who have defaulted on 
                loans guaranteed under this subpart; and
            (5) provide technical assistance to borrowers, 
        lenders, holders, and institutions concerning 
        deferments and collection activities.
    (c) Additional Duties.--In conjunction with the report 
submitted under subsection (b), the Office shall--
            (1) compile, and publish in the Federal Register, a 
        list of the borrowers who are in default under this 
        subpart; and
            (2) send the report and notices of default with 
        respect to these borrowers to relevant Federal agencies 
        and to schools, school associations, professional and 
        specialty associations, State licensing boards, 
        hospitals with which such borrowers may be associated, 
        and any other relevant organizations.
    (d) Allocation of Funds for Office.--In the case of amounts 
reserved under section 710(a)(2)(B) for obligation under this 
subsection, the Secretary may obligate the amounts for the 
purpose of administering the Office, including 7 full-time 
equivalent employment positions for such Office. With respect 
to such purpose, amounts made available under the preceding 
sentence are in addition to amounts made available to the 
Health Resources and Services Administration for program 
management for the fiscal year involved. With respect to such 
employment positions, the positions are in addition to the 
number of full-time equivalent employment positions that 
otherwise is authorized for the Department of Health and Human 
Services for the fiscal year involved.

SEC. 710. [292I] INSURANCE ACCOUNT.

    (a) In General.--
            (1) Establishment.--There is hereby established a 
        student loan insurance account (in this section 
        referred to as the ``Account'') which shall be 
        available without fiscal year limitation to the 
        Secretary for making payments in connection with the 
        collection and default of loans insured under this 
        subpart by the Secretary.
            (2) Funding.--
                    (A) Except as provided in subparagraph (B), 
                all amounts received by the Secretary as 
                premium charges for insurance and as receipts, 
                earnings, or proceeds derived from any claim or 
                other assets acquired by the Secretary in 
                connection with his operations under this 
                subpart, and any other moneys, property, or 
                assets derived by the Secretary from the 
                operations of the Secretary in connection with 
                this section, shall be deposited in the 
                Account.
                    (B) With respect to amounts described in 
                subparagraph (A) that are received by the 
                Secretary for fiscal year 1993 and subsequent 
                fiscal years, the Secretary may, before 
                depositing such amounts in the Account, reserve 
                from the amounts each such fiscal year not more 
                than $1,000,000 for obligation under section 
                709(d).
            (3) Expenditures.--All payments in connection with 
        the default of loans insured by the Secretary under 
        this subpart shall be paid from the Account.
    (b) Contingent Authority for Issuance of Notes or Other 
Obligations.--If at any time the moneys in the Account are 
insufficient to make payments in connection with the collection 
or default of any loan insured by the Secretary under this 
subpart, the Secretary of the Treasury may lend the Account 
such amounts as may be necessary to make the payments involved, 
subject to the Federal Credit Reform Act of 1990.

SEC. 711. [292J] POWERS AND RESPONSIBILITIES OF SECRETARY.

    (a) In General.--In the performance of, and with respect 
to, the functions, powers, and duties vested in the Secretary 
by this subpart, the Secretary is authorized as follows:
            (1) To prescribe such regulations as may be 
        necessary to carry out the purposes of this subpart.
            (2) To sue and be sued in any district court of the 
        United States. Such district courts shall have 
        jurisdiction of civil actions arising under this 
        subpart without regard to the amount in controversy, 
        and any action instituted under this subsection by or 
        against the Secretary shall survive notwithstanding any 
        change in the person occupying the office of Secretary 
        or any vacancy in that office. No attachment, 
        injunction, garnishment, or other similar process, 
        mesne or final, shall be issued against the Secretary 
        or property under the control of the Secretary. Nothing 
        herein shall be constructed to except litigation 
        arising out of activities under this subpart from the 
        application of sections 517 and 547 of title 28 of the 
        United States Code.
            (3) To include in any contract for Federal loan 
        insurance such terms, conditions, and covenants 
        relating to repayment of principal and payments of 
        interest, relating to his obligations and rights and to 
        those of eligible lenders, and borrowers in case of 
        default, and relating to such other matters as the 
        Secretary determines to be necessary to assure that the 
        purposes of this subpart will be achieved. Any term, 
        condition, and covenant made pursuant to this paragraph 
        or any other provisions of this subpart may be modified 
        by the Secretary if the Secretary determines that 
        modification is necessary to protect the financial 
        interest of the United States.
            (4) Subject to the specific limitations in the 
        subpart, to consent to the modification of any note or 
        other instrument evidencing a loan which has been 
        insured by him under this subpart (including 
        modifications with respect to the rate of interest, 
        time of payment of any installment of principal and 
        interest or any portion thereof, or any other 
        provision).
            (5) To enforce, pay, compromise, waive, or release 
        any right, title, claim, lien, or demand, however 
        acquired, including any equity or any right or \1\ 
        redemption.
---------------------------------------------------------------------------
    \1\ So in law. See section 102 of Public Law 102-408 (106 Stat. 
1994). Probably should be ``right of redemption''.
---------------------------------------------------------------------------
    (b) Annual Budget; Accounts.--The Secretary shall, with 
respect to the financial operations arising by reason of this 
subpart--
            (1) prepare annually and submit a budget program as 
        provided for wholly owned Government corporations by 
        the Government Corporation Control Act; and
            (2) maintain with respect to insurance under this 
        subpart an integral set of accounts.

SEC. 712. [292K] PARTICIPATION BY FEDERAL CREDIT UNIONS IN FEDERAL, 
                    STATE, AND PRIVATE STUDENT LOAN INSURANCE PROGRAMS.

    Notwithstanding any other provision of law, Federal credit 
unions shall, pursuant to regulations of the Administrator of 
the National Credit Union Administration, have power to make 
insured loans to eligible students in accordance with the 
provisions of this subpart relating to Federal insured loans.

SEC. 713. [292L] DETERMINATION OF ELIGIBLE STUDENTS.

    For purposes of determining eligible students under this 
part, in the case of a public school in a State that offers an 
accelerated, integrated program of study combining 
undergraduate premedical education and medical education 
leading to advanced entry, by contractual agreement, into an 
accredited four-year school of medicine which provides the 
remaining training leading to a degree of doctor of medicine, 
whenever in this part a provision refers to a student at a 
school of medicine, such reference shall include only a student 
enrolled in any of the last four years of such accelerated, 
integrated program of study.

SEC. 714. [292M] REPAYMENT BY SECRETARY OF LOANS OF DECEASED OR 
                    DISABLED BORROWERS.

    If a borrower who has received a loan dies or becomes 
permanently and totally disabled (as determined in accordance 
with regulations of the Secretary), the Secretary shall 
discharge the borrower's liability on the loan by repaying the 
amount owed on the loan from the account established under 
section 710.

SEC. 715. [292N] ADDITIONAL REQUIREMENTS FOR INSTITUTIONS AND LENDERS.

    (a) In General.--Notwithstanding any other provision of 
this subpart, the Secretary is authorized to prescribe such 
regulations as may be necessary to provide for--
            (1) a fiscal audit of an eligible institution with 
        regard to any funds obtained from a borrower who has 
        received a loan insured under this subpart;
            (2) the establishment of reasonable standards of 
        financial responsibility and appropriate institutional 
        capability for the administration by an eligible 
        institution of a program of student financial aid with 
        respect to funds obtained from a student who has 
        received a loan insured under this subpart;
            (3) the limitation, suspension, or termination of 
        the eligibility under this subpart of any otherwise 
        eligible institution, whenever the Secretary has 
        determined, after notice and affording an opportunity 
        for hearing, that such institution has violated or 
        failed to carry out any regulation prescribed under 
        this subpart;
            (4) the collection of information from the 
        borrower, lender, or eligible institution to assure 
        compliance with the provisions of section 705;
            (5) the assessing of tuition or fees to borrowers 
        in amounts that are the same or less than the amount of 
        tuition and fees assessed to nonborrowers;
            (6) the submission, by the institution or the 
        lender to the Office of Health Education Assistance 
        Loan Default Reduction, of information concerning each 
        loan made under this subpart, including the date when 
        each such loan was originated, the date when each such 
        loan is sold, the identity of the loan holder and 
        information concerning a change in the borrower's 
        status;
            (7) the withholding of services, including academic 
        transcripts, financial aid transcripts, and alumni 
        services, by an institution from a borrower upon the 
        default of such borrower of a loan under this subpart, 
        except in case of a borrower who has filed for 
        bankruptcy; and
            (8) the offering, by the lender to the borrower, of 
        a variety of repayment options, including fixed-rate, 
        graduated repayment with negative amortization 
        permitted, and income dependent payments for a limited 
        period followed by level monthly payments.
    (b) Recording by Institution of Information on Students.--
The Secretary shall require an eligible institution to record, 
and make available to the lender and to the Secretary upon 
request, the name, address, postgraduate destination, and other 
reasonable identifying information for each student of such 
institution who has a loan insured under this subpart.
    (c) Workshop for Student Borrowers.--Each participating 
eligible institution must have, at the beginning of each 
academic year, a workshop concerning the provisions of this 
subpart that all student borrowers shall be required to attend.

SEC. 719. [292O] DEFINITIONS.

    For purposes of this subpart:
            (1) The term ``eligible institution'' means, with 
        respect to a fiscal year, a school of medicine, 
        osteopathic medicine, dentistry, veterinary medicine, 
        optometry, podiatric medicine, pharmacy, public health, 
        allied health, or chiropractic, or a graduate program 
        in health administration or behavioral and mental 
        health practice, including clinical psychology.
            (2) The term ``eligible lender'' means an eligible 
        institution that became a lender under this subpart 
        prior to September 15, 1992, an agency or 
        instrumentality of a State, a financial or credit 
        institution (including an insurance company) which is 
        subject to examination and supervision by an agency of 
        the United States or of any State, a pension fund 
        approved by the Secretary for this purpose, or a 
        nonprofit private entity designated by the State, 
        regulated by the State, and approved by the Secretary.
            (3) The term ``line of credit'' means an 
        arrangement or agreement between the lender and the 
        borrower whereby a loan is paid out by the lender to 
        the borrower in annual installments, or whereby the 
        lender agrees to make, in addition to the initial loan, 
        additional loans in subsequent years.
            (4) The term ``school of allied health'' means a 
        program in a school of allied health (as defined in 
        section 799) which leads to a masters' degree or a 
        doctoral degree.
            (5)(A) The term ``default rate'', in the case of an 
        eligible entity, means the percentage constituted by 
        the ratio of--
                    (i) the principal amount of loans insured 
                under this subpart--
                            (I) that are made with respect to 
                        the entity and that enter repayment 
                        status after April 7, 1987; and
                            (II) for which amounts have been 
                        paid under section 707(a) to insurance 
                        beneficiaries, exclusive of any loan 
                        for which amounts have been so paid as 
                        a result of the death or total and 
                        permanent disability of the borrower; 
                        exclusive of any loan for which the 
                        borrower begins payments to the 
                        Secretary on the loan pursuant to 
                        section 707(b) and maintains payments 
                        for 12 consecutive months in accordance 
                        with the agreement involved (with the 
                        loan subsequently being included or 
                        excluded, as the case may be, as 
                        amounts paid under section 707(a) 
                        according to whether further defaults 
                        occur and whether with respect to the 
                        default involved compliance with such 
                        requirement regarding 12 consecutive 
                        months occurs); and exclusive of any 
                        loan on which payments may not be 
                        recovered by reason of the obligation 
                        under the loan being discharged in 
                        bankruptcy under title 11, United 
                        States Code; to
                    (ii) the total principal amount of loans 
                insured under this subpart that are made with 
                respect to the entity and that enter repayment 
                status after April 7, 1987.
            (B) For purposes of subparagraph (A), a loan 
        insured under this subpart shall be considered to have 
        entered repayment status if the applicable period 
        described in subparagraph (B) of section 705(a)(2) 
        regarding the loan has expired (without regard to 
        whether any period described in subparagraph (C) of 
        such section is applicable regarding the loan).
            (C) For purposes of subparagraph (A), the term 
        ``eligible entity'' means an eligible institution, an 
        eligible lender, or a holder, as the case may be.
            (D) For purposes of subparagraph (A), a loan is 
        made with respect to an eligible entity if--
            (i) in the case of an eligible institution, the 
        loan was made to students of the institution;
            (ii) in the case of an eligible lender, the loan 
        was made by the lender; and
            (iii) in the case of a holder, the loan was 
        purchased by the holder.

SEC. 720. [292P] AUTHORIZATION OF APPROPRIATIONS.

    (a) In General.--For fiscal year 1993 and subsequent fiscal 
years, there are authorized to be appropriated such sums as may 
be necessary for the adequacy of the student loan insurance 
account under this subpart and for the purpose of administering 
this subpart.
    (b) Availability of Sums.--Sums appropriated under 
subsection (a) shall remain available until expended.

           Subpart II--Federally-Supported Student Loan Funds

SEC. 721. [292Q] AGREEMENTS FOR OPERATION OF SCHOOL LOAN FUNDS.

    (a) Fund Agreements.--The Secretary is authorized to enter 
into an agreement for the establishment and operation of a 
student loan fund in accordance with this subpart with any 
public or other nonprofit school of medicine, osteopathic 
medicine, dentistry, pharmacy, podiatric medicine, optometry, 
or veterinary medicine.
    (b) Requirements.--Each agreement entered into under this 
section shall--
            (1) provide for establishment of a student loan 
        fund by the school;
            (2) provide for deposit in the fund of--
                    (A) the Federal capital contributions to 
                the fund;
                    (B) an amount equal to not less than one-
                ninth of such Federal capital contributions, 
                contributed by such institution;
                    (C) collections of principal and interest 
                on loans made from the fund;
                    (D) collections pursuant to section 722(j); 
                and
                    (E) any other earnings of the fund;
            (3) provide that the fund shall be used only for 
        loans to students of the school in accordance with the 
        agreement and for costs of collection of such loans and 
        interest thereon;
            (4) provide that loans may be made from such funds 
        only to students pursuing a full-time course of study 
        at the school leading to a degree of doctor of 
        medicine, doctor of dentistry or an equivalent degree, 
        doctor of osteopathy, bachelor of science in pharmacy 
        or an equivalent degree, doctor of pharmacy or an 
        equivalent degree, doctor of podiatric medicine or an 
        equivalent degree, doctor of optometry or an equivalent 
        degree, or doctor of veterinary medicine or an 
        equivalent degree;
            (5) provide that the school shall advise, in 
        writing, each applicant for a loan from the student 
        loan fund of the provisions of section 722 under which 
        outstanding loans from the student loan fund may be 
        paid (in whole or in part) by the Secretary; and
            (6) contain such other provisions as are necessary 
        to protect the financial interests of the United 
        States.
    (c) Failure of School To Collect Loans.--
            (1) In general.--Any standard established by the 
        Secretary by regulation for the collection by schools 
        of medicine, osteopathic medicine, dentistry, pharmacy, 
        podiatric medicine, optometry, or veterinary medicine 
        of loans made pursuant to loan agreements under this 
        subpart shall provide that the failure of any such 
        school to collect such loans shall be measured in 
        accordance with this subsection. This subsection may 
        not be construed to require such schools to reimburse 
        the student loan fund under this subpart for loans that 
        became uncollectible prior to August 1985 or to 
        penalize such schools with respect to such loans.
            (2) Extent of failure.--The measurement of a 
        school's failure to collect loans made under this 
        subpart shall be the ratio (stated as a percentage) 
        that the defaulted principal amount outstanding of such 
        school bears to the matured loans of such school.
            (3) Definitions.--For purposes of this subsection:
                    (A) The term ``default'' means the failure 
                of a borrower of a loan made under this subpart 
                to--
                            (i) make an installment payment 
                        when due; or
                            (ii) comply with any other term of 
                        the promissory note for such loan,
                except that a loan made under this subpart 
                shall not be considered to be in default if the 
                loan is discharged in bankruptcy or if the 
                school reasonably concludes from written 
                contracts with the borrower that the borrower 
                intends to repay the loan.
                    (B) The term ``defaulted principal amount 
                outstanding'' means the total amount borrowed 
                from the loan fund of a school that has reached 
                the repayment stage (minus any principal amount 
                repaid or canceled) on loans--
                            (i) repayable monthly and in 
                        default for at least 120 days; and
                            (ii) repayable less frequently than 
                        monthly and in default for at least 180 
                        days;
                    (C) The term ``grace period'' means the 
                period of one year beginning on the date on 
                which the borrower ceases to pursue a full-time 
                course of study at a school of medicine, 
                osteopathic medicine, dentistry, pharmacy, 
                podiatric medicine, optometry, or veterinary 
                medicine; and
                    (D) The term ``matured loans'' means the 
                total principal amount of all loans made by a 
                school under this subpart minus the total 
                principal amount of loans made by such school 
                to students who are--
                            (i) enrolled in a full-time course 
                        of study at such school; or
                            (ii) in their grace period.

SEC. 722. [292R] LOAN PROVISIONS.

    (a) Amount of Loan.--
            (1) In general.--Loans from a student loan fund 
        (established under an agreement with a school under 
        section 721) may not, subject to paragraph (2), exceed 
        for any student for a school year (or its equivalent) 
        the cost of attendance (including tuition, other 
        reasonable educational expenses, and reasonable living 
        costs) for that year at the educational institution 
        attended by the student (as determined by such 
        educational institution).
            (2) Third and fourth years of medical school.--For 
        purposes of paragraph (1), the amount of the loan may, 
        in the case of the third or fourth year of a student at 
        a school of medicine or osteopathic medicine, be 
        increased to the extent necessary to pay the balances 
        of loans that, from sources other than the student loan 
        fund under section 721, were made to the individual for 
        attendance at the school. The authority to make such an 
        increase is subject to the school and the student 
        agreeing that such amount (as increased) will be 
        expended to pay such balances.
    (b) Terms and Conditions.--Subject to section 723, any such 
loans shall be made on such terms and conditions as the school 
may determine, but may be made only to a student--
            (1) who is in need of the amount thereof to pursue 
        a full-time course of study at the school leading to a 
        degree of doctor of medicine, doctor of dentistry or an 
        equivalent degree, doctor of osteopathy, bachelor of 
        science in pharmacy or an equivalent degree, doctor of 
        pharmacy or an equivalent degree, doctor of podiatric 
        medicine or an equivalent degree, doctor of optometry 
        or an equivalent degree, or doctor of veterinary 
        medicine or an equivalent degree; and
            (2) who, if required under section 3 of the 
        Military Selective Service Act to present himself for 
        and submit to registration under such section, has 
        presented himself and submitted to registration under 
        such section.
    (c) Repayment; Exclusions From Repayment Period.--Such 
loans shall be repayable in equal or graduated periodic 
installments (with the right of the borrower to accelerate 
repayment) over the period of not less than 10 years nor more 
than 25 years, at the discretion of the institution, which 
begins one year after the student ceases to pursue a full-time 
course of study at a school of medicine, osteopathic medicine, 
dentistry, pharmacy, podiatry, optometry, or veterinary 
medicine, excluding from such period--
            (1) all periods--
                    (A) not in excess of three years of active 
                duty performed by the borrower as a member of a 
                uniformed service;
                    (B) not in excess of three years during 
                which the borrower serves as a volunteer under 
                the Peace Corps Act;
                    (C) during which the borrower participates 
                in advanced professional training, including 
                internships and residencies; and
                    (D) during which the borrower is pursuing a 
                full-time course of study at such a school; and
            (2) a period--
                    (A) not in excess of two years during which 
                a borrower who is a full-time student in such a 
                school leaves the school, with the intent to 
                return to such school as a full-time student, 
                in order to engage in a full-time educational 
                activity which is directly related to the 
                health profession for which the borrower is 
                preparing, as determined by the Secretary; or
                    (B) not in excess of two years during which 
                a borrower who is a graduate of such a school 
                is a participant in a fellowship training 
                program or a full-time educational activity 
                which--
                            (i) is directly related to the 
                        health profession for which such 
                        borrower prepared at such school, as 
                        determined by the Secretary; and
                            (ii) may be engaged in by the 
                        borrower during such a two-year period 
                        which begins within twelve months after 
                        the completion of the borrower's 
                        participation in advanced professional 
                        training described in paragraph (1)(C) 
                        or prior to the completion of such 
                        borrower's participation in such 
                        training.
    (d) Cancellation of Liability.--The liability to repay the 
unpaid balance of such a loan and accrued interest thereon 
shall be canceled upon the death of the borrower, or if the 
Secretary determines that he has become permanently, and 
totally disabled.
    (e) Rate of Interest.--Such loans shall bear interest, on 
the unpaid balance of the loan, computed only for periods for 
which the loan is repayable, at the rate of 5 percent per year.
    (f) Security or Endorsement.--Loans shall be made under 
this subpart without security or endorsement, except that if 
the borrower is a minor and the note or other evidence of 
obligation executed by him would not, under the applicable law, 
create a binding obligation, either security or endorsement may 
be required.
    (g) Transferring and Assigning Loans.--No note or other 
evidence of a loan made under this subpart may be transferred 
or assigned by the school making the loan except that, if the 
borrowers transfer to another school participating in the 
program under this subpart, such note or other evidence of a 
loan may be transferred to such other school.
    (h) Charge With Respect to Insurance for Certain 
Cancellations.--Subject to regulations of the Secretary, a 
school may assess a charge with respect to loans made this \1\ 
subpart to cover the costs of insuring against cancellation of 
liability under subsection (d).
---------------------------------------------------------------------------
    \1\ So in law. See section 102 of Public Law 102-408 (106 Stat. 
1994). Probably should be ``made under this subpart''.
---------------------------------------------------------------------------
    (i) Charge With Respect to Late Payments.--Subject to 
regulations of the Secretary, and in accordance with this 
section, a school shall assess a charge with respect to a loan 
made under this subpart for failure of the borrower to pay all 
or any part of an installment when it is due and, in the case 
of a borrower who is entitled to deferment of the loan under 
subsection (c), for any failure to file timely and satisfactory 
evidence of such entitlement. No such charge may be made if the 
payment of such installment or the filing of such evidence is 
made within 60 days after the date on which such installment or 
filing is due. The amount of any such charge may not exceed an 
amount equal to 6 percent of the amount of such installment. 
The school may elect to add the amount of any such charge to 
the principal amount of the loan as of the first day after the 
day on which such installment or evidence was due, or to make 
the amount of the charge payable to the school not later than 
the due date of the next installment after receipt by the 
borrower of notice of the assessment of the charge.
    (j) Authority of Schools Regarding Rate of Payment.--A 
school may provide, in accordance with regulations of the 
Secretary, that during the repayment period of a loan from a 
loan fund established pursuant to an agreement under this 
subpart payments of principal and interest by the borrower with 
respect to all the outstanding loans made to him from loan 
funds so established shall be at a rate equal to not less than 
$40 per month.
    (k) Authority Regarding Repayments by Secretary.--Upon 
application by a person who received, and is under an 
obligation to repay, any loan made to such person as a health 
professions student to enable him to study medicine, 
osteopathy, dentistry, veterinary medicine, optometry, 
pharmacy, or podiatry, the Secretary may undertake to repay 
(without liability to the applicant) all or any part of such 
loan, and any interest or portion thereof outstanding thereon, 
upon his determination, pursuant to regulations establishing 
criteria therefor, that the applicant--
            (1) failed to complete such studies leading to his 
        first professional degree;
            (2) is in exceptionally needy circumstances;
            (3) is from a low-income or disadvantaged family as 
        those terms may be defined by such regulations; and
            (4) has not resumed, or cannot reasonably be 
        expected to resume, the study of medicine, osteopathy, 
        dentistry, veterinary medicine, optometry, pharmacy, or 
        podiatric medicine, within two years following the date 
        upon which he terminated such studies.
    (l) Collection Efforts by Secretary.--The Secretary is 
authorized to attempt to collect any loan which was made under 
this subpart, which is in default, and which was referred to 
the Secretary by a school with which the Secretary has an 
agreement under this subpart, on behalf of that school under 
such terms and conditions as the Secretary may prescribe 
(including reimbursement from the school's student loan fund 
for expenses the Secretary may reasonably incur in attempting 
collection), but only if the school has complied with such 
requirements as the Secretary may specify by regulation with 
respect to the collection of loans under this subpart. A loan 
so referred shall be treated as a debt subject to section 5514 
of title 5, United States Code. Amounts collected shall be 
deposited in the school's student loan fund. Whenever the 
Secretary desires the institution of a civil action regarding 
any such loan, the Secretary shall refer the matter to the 
Attorney General for appropriate action.
    (m) Elimination of Statute of Limitation for Loan 
Collections.--
            (1) Purpose.--It is the purpose of this subsection 
        to ensure that obligations to repay loans under this 
        section are enforced without regard to any Federal or 
        State statutory, regulatory, or administrative 
        limitation on the period within which debts may be 
        enforced.
            (2) Prohibition.--Notwithstanding any other 
        provision of Federal or State law, no limitation shall 
        terminate the period within which suit may be filed, a 
        judgment may be enforced, or an offset, garnishment, or 
        other action may be initiated or taken by a school that 
        has an agreement with the Secretary pursuant to section 
        721 that is seeking the repayment of the amount due 
        from a borrower on a loan made under this subpart after 
        the default of the borrower on such loan.

SEC. 723. [292S] MEDICAL SCHOOLS AND PRIMARY HEALTH CARE.

    (a) Requirements for Students.--
            (1) In general.--Subject to the provisions of this 
        subsection, in the case of student loan funds 
        established under section 721 by schools of medicine or 
        osteopathic medicine, each agreement entered into under 
        such section with such a school shall provide (in 
        addition to the provisions required in subsection (b) 
        of such section) that the school will make a loan from 
        such fund to a student only if the student agrees--
                    (A) to enter and complete a residency 
                training program in primary health care not 
                later than 4 years after the date on which the 
                student graduates from such school; and
                    (B) to practice in such care for 10 years 
                (including residency training in primary health 
                care) or through the date on which the loan is 
                repaid in full, whichever occurs first.
            (2) Inapplicability to certain students.--
                    (A) The requirement established in 
                paragraph (1) regarding the student loan fund 
                of a school does not apply to a student if--
                            (i) the first loan to the student 
                        from such fund is made before July 1, 
                        1993; or
                            (ii) the loan is made from--
                                    (I) a Federal capital 
                                contribution under section 721 
                                that is made from amounts 
                                appropriated under section 
                                724(f) (in this section 
                                referred to as an ``exempt 
                                Federal capital 
                                contribution''); or
                                    (II) a school contribution 
                                made under section 721 pursuant 
                                to such a Federal capital 
                                contribution (in this section 
                                referred to as an ``exempt 
                                school contribution'').
                    (B) A Federal capital contribution under 
                section 721 may not be construed as being an 
                exempt Federal capital contribution if the 
                contribution was made from amounts appropriated 
                before October 1, 1990. A school contribution 
                under section 721 may not be construed as being 
                an exempt school contribution if the 
                contribution was made pursuant to a Federal 
                capital contribution under such section that 
                was made from amounts appropriated before such 
                date.
            (3) Noncompliance by student.--Each agreement 
        entered into with a student pursuant to paragraph (1) 
        shall provide that, if the student fails to comply with 
        such agreement, the loan involved will begin to accrue 
        interest at a rate of 2 percent per year greater than 
        the rate at which the student would pay if compliant in 
        such year.
            (4) Waivers.--
                    (A) With respect to the obligation of an 
                individual under an agreement made under 
                paragraph (1) as a student, the Secretary shall 
                provide for the partial or total waiver or 
                suspension of the obligation whenever 
                compliance by the individual is impossible, or 
                would involve extreme hardship to the 
                individual, and if enforcement of the 
                obligation with respect to the individual would 
                be unconscionable.
                    (B) For purposes of subparagraph (A), the 
                obligation of an individual shall be waived 
                if--
                            (i) the status of the individual as 
                        a student of the school involved is 
                        terminated before graduation from the 
                        school, whether voluntarily or 
                        involuntarily; and
                            (ii) the individual does not, after 
                        such termination, resume attendance at 
                        the school or begin attendance at any 
                        other school of medicine or osteopathic 
                        medicine.
                    (C) If an individual resumes or begins 
                attendance for purposes of subparagraph (B), 
                the obligation of the individual under the 
                agreement under paragraph (1) shall be 
                considered to have been suspended for the 
                period in which the individual was not in 
                attendance.
                    (D) This paragraph may not be construed as 
                authorizing the waiver or suspension of the 
                obligation of a student to repay, in accordance 
                with section 722, loans from student loan funds 
                under section 721.
    (b) Requirements for Schools.--
            (1) In general.--Subject to the provisions of this 
        subsection, in the case of student loan funds 
        established under section 721 by schools of medicine or 
        osteopathic medicine, each agreement entered into under 
        such section with such a school shall provide (in 
        addition to the provisions required in subsection (b) 
        of such section) that, for the 1-year period ending on 
        June 30, 1997; \1\ and for the 1-year period ending on 
        June 30 of each subsequent fiscal year, the school will 
        meet not less than 1 of the conditions described in 
        paragraph (2) with respect to graduates of the school 
        whose date of graduation from the school occurred 
        approximately 4 years before the end of the 1-year 
        period involved.
---------------------------------------------------------------------------
    \1\ So in law. See section 2014(c)(2)(A)(i) of Public Law 103-43 
(107 Stat. 216). The semicolon probably should be a comma.
---------------------------------------------------------------------------
            (2) Description of conditions.--With respect to 
        graduates described in paragraph (1) (in this paragraph 
        referred to as ``designated graduates''), the 
        conditions referred to in such paragraph for a school 
        for a 1-year period are as follows:
                    (A) Not less than 50 percent of designated 
                graduates of the school meet the criterion of 
                either being in a residency training program in 
                primary health care, or being engaged in a 
                practice in such care (having completed such a 
                program).
                    (B) Not less than 25 percent of the 
                designated graduates of the school meet such 
                criterion, and such percentage is not less than 
                5 percentage points above the percentage of 
                such graduates meeting such criterion for the 
                preceding 1-year period.
                    (C) In the case of schools of medicine or 
                osteopathic medicine with student loans funds 
                under section 721, the school involved is at or 
                above the 75th percentile of such schools whose 
                designated graduates meet such criterion.
            (3) Determinations by secretary.--Not later than 90 
        days after the close of each 1-year period described in 
        paragraph (1), the Secretary shall make a determination 
        of whether the school involved has for such period 
        complied with such paragraph and shall in writing 
        inform the school of the determination. Such 
        determination shall be made only after consideration of 
        the report submitted to the Secretary by the school 
        under paragraph (6).
            (4) Noncompliance by school.--
                    (A)(i) Subject to subparagraph (C), each 
                agreement under section 721 with a school of 
                medicine or osteopathic medicine shall provide 
                that, if the school fails to comply with 
                paragraph (1) for a 1-year period under such 
                paragraph, the school--
                                    (I) will pay to the 
                                Secretary the amount applicable 
                                under subparagraph (B) for the 
                                period; and
                                    (II) will pay such amount 
                                not later than 90 days after 
                                the school is informed under 
                                paragraph (3) of the 
                                determination of the Secretary 
                                regarding such period.
                    (ii) Any amount that a school is required 
                to pay under clause (i) may be paid from the 
                student loan fund of the school under section 
                721.
                    (B) For purposes of subparagraph (A), the 
                amount applicable for a school, subject to 
                subparagraph (C), is--
                            (i) for the 1-year period ending 
                        June 30, 1997, an amount equal to 10 
                        percent of the income received during 
                        such period by the student loan fund of 
                        the school under section 721;
                            (ii) for the 1-year period ending 
                        June 30, 1998, an amount equal to 20 
                        percent of the income received during 
                        such period by the student loan fund; 
                        and
                            (iii) for any subsequent 1-year 
                        period under paragraph (1), an amount 
                        equal to 30 percent of the income 
                        received during such period by the 
                        student loan fund.
                    (C) In determining the amount of income 
                that a student loan fund has received for 
                purposes of subparagraph (B), the Secretary 
                shall exclude any income derived from exempt 
                contributions. Payments made to the Secretary 
                under subparagraph (A) may not be made with 
                such contributions or with income derived from 
                such contributions.
            (5) Expenditure of payments.--
                    (A) Amounts paid to the Secretary under 
                paragraph (4) shall be expended to make Federal 
                capital contributions to student loan funds 
                under section 721 of schools that are in 
                compliance with paragraph (1).
                    (B) A Federal capital contribution under 
                section 721 may not be construed as being an 
                exempt Federal capital contribution if the 
                contribution is made from payments under 
                subparagraph (A). A school contribution under 
                such section may not be construed as being an 
                exempt school contribution if the contribution 
                is made pursuant to a Federal capital 
                contribution from such payments.
            (6) Reports by schools.--Each agreement under 
        section 721 with a school of medicine or osteopathic 
        medicine shall provide that the school will submit to 
        the Secretary a report for each 1-year period under 
        paragraph (1) that provides such information as the 
        Secretary determines to be necessary for carrying out 
        this subsection. Each such report shall include 
        statistics concerning the current training or practice 
        status of all graduates of such school whose date of 
        graduation from the school occurred approximately 4 
        years before the end of the 1-year period involved.
    (c) Definitions.--For purposes of this section:
            (1) The term ``exempt contributions'' means exempt 
        Federal capital contributions and exempt school 
        contributions.
            (2) The term ``exempt Federal capital 
        contribution'' means a Federal capital contribution 
        described in subclause (I) of subsection (a)(2)(A)(ii).
            (3) The term ``exempt school contribution'' means a 
        school contribution described in subclause (II) of 
        subsection (a)(2)(A)(ii).
            (4) The term ``income'', with respect to a student 
        fund under section 721, means payments of principal and 
        interest on any loan made from the fund, and any other 
        earnings of the fund.
            (5) The term ``primary health care'' means family 
        medicine, general internal medicine, general 
        pediatrics, preventive medicine, or osteopathic general 
        practice.
    (d) Sense of Congress.--It is the sense of Congress that 
funds repaid under the loan program under this section should 
not be transferred to the Treasury of the United States or 
otherwise used for any other purpose other than to carry out 
this section.

SEC. 724. [292T] INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS.

    (a) Fund Agreements Regarding Certain Amounts.--With 
respect to amounts appropriated under subsection (f), each 
agreement entered into under section 721 with a school shall 
provide (in addition to the provisions required in subsection 
(b) of such section) that--
            (1) any Federal capital contribution made to the 
        student loan fund of the school from such amounts, 
        together with the school contribution appropriate under 
        subsection (b)(2)(B) of such section to the amount of 
        the Federal capital contribution, will be utilized only 
        for the purpose of--
                    (A) making loans to individuals from 
                disadvantaged backgrounds; and
                    (B) the costs of the collection of the 
                loans and interest on the loans; and
            (2) collections of principal and interest on loans 
        made pursuant to paragraph (1), and any other earnings 
        of the student loan fund attributable to amounts that 
        are in the fund pursuant to such paragraph, will be 
        utilized only for the purpose described in such 
        paragraph.
    (b) Minimum Qualifications for Schools.--The Secretary may 
not make a Federal capital contribution for purposes of 
subsection (a) for a fiscal year unless the health professions 
school involved--
            (1) is carrying out a program for recruiting and 
        retaining students from disadvantaged backgrounds, 
        including racial and ethnic minorities; and
            (2) is carrying out a program for recruiting and 
        retaining minority faculty.
    (c) Certain Agreements Regarding Education of Students; 
Date Certain for Compliance.--The Secretary may not make a 
Federal capital contribution for purposes of subsection (a) for 
a fiscal year unless the health professions school involved 
agrees--
            (1) to ensure that adequate instruction regarding 
        minority health issues is provided for in the curricula 
        of the school;
            (2) with respect to health clinics providing 
        services to a significant number of individuals who are 
        from disadvantaged backgrounds, including members of 
        minority groups, to enter into arrangements with 1 or 
        more such clinics for the purpose of providing students 
        of the school with experience in providing clinical 
        services to such individuals;
            (3) with respect to public or nonprofit private 
        secondary educational institutions and undergraduate 
        institutions of higher education, to enter into 
        arrangements with 1 or more such institutions for the 
        purpose of carrying out programs regarding the 
        educational preparation of disadvantaged students, 
        including minority students, to enter the health 
        professions and regarding the recruitment of such 
        individuals into the health professions;
            (4) to establish a mentor program for assisting 
        disadvantaged students, including minority students, 
        regarding the completion of the educational 
        requirements for degrees from the school;
            (5) to be carrying out each of the activities 
        specified in any of paragraphs (1) through (4) by not 
        later than 1 year after the date on which the first 
        Federal capital contribution is made to the school for 
        purposes of subsection (a); and
            (6) to continue carrying out such activities, and 
        the activities specified in paragraphs (1) and (2) of 
        subsection (b), throughout the period during which the 
        student loan fund established pursuant to section 
        721(b) is in operation.
    (d) Availability of Other Amounts.--With respect to Federal 
capital contributions to student loan funds under agreements 
under section 721(b), any such contributions made before 
October 1, 1990, together with the school contributions 
appropriate under paragraph (2)(B) of such section to the 
amount of the Federal capital contributions, may be utilized 
for the purpose of making loans to individuals from 
disadvantaged backgrounds, subject to section 723(a)(2)(B).
    (e) Definition.--For purposes of this section, the term 
``disadvantaged'', with respect to an individual, shall be 
defined by the Secretary.
    (f) Authorization of Appropriations.--
            (1) \1\ In general.--With respect to making Federal 
        capital contributions to student loan funds for 
        purposes of subsection (a), there is authorized to be 
        appropriated for such contributions $8,000,000 for each 
        of the fiscal years 1998 through 2002.
---------------------------------------------------------------------------
    \1\ Effective October 1, 2002, this paragraph is repealed by 
section 132(b) of Public Law 105-392 (112 Stat. 3575).
---------------------------------------------------------------------------
            (2) Special consideration for certain schools.--In 
        making Federal capital contributions to student loan 
        funds for purposes of subsection (a), the Secretary 
        shall give special consideration to health professions 
        schools that have enrollments of underrepresented 
        minorities above the national average for health 
        professions schools.

SEC. 725.  [292U] ADMINISTRATIVE PROVISIONS.

    The Secretary may agree to modifications of agreements or 
loans made under this subpart, and may compromise, waive, or 
release any right, title, claim, or demand of the United States 
arising or acquired under this subpart.

SEC. 726. [292V] PROVISION BY SCHOOLS OF INFORMATION TO STUDENTS.

    (a) In General.--With respect to loans made by a school 
under this subpart after June 30, 1986, each school, in order 
to carry out the provisions of sections 721 and 722, shall, at 
any time such school makes such a loan to a student under this 
subpart, provide thorough and adequate loan information on 
loans made under this subpart to the student. The loan 
information required to be provided to the student by this 
subsection shall include--
            (1) the yearly and cumulative maximum amounts that 
        may be borrowed by the student;
            (2) the terms under which repayment of the loan 
        will begin;
            (3) the maximum number of years in which the loan 
        must be repaid;
            (4) the interest rate that will be paid by the 
        borrower and the minimum amount of the required monthly 
        payment;
            (5) the amount of any other fees charged to the 
        borrower by the lender;
            (6) any options the borrower may have for deferral, 
        cancellation, prepayment, consolidation, or other 
        refinancing of the loan;
            (7) a definition of default on the loan and a 
        specification of the consequences which will result to 
        the borrower if the borrower defaults, including a 
        description of any arrangements which may be made with 
        credit bureau organizations;
            (8) to the extent practicable, the effect of 
        accepting the loan on the eligibility of the borrower 
        for other forms of student assistance; and
            (9) a description of the actions that may be taken 
        by the Federal Government to collect the loan, 
        including a description of the type of information 
        concerning the borrower that the Federal Government may 
        disclose to (A) officers, employees, or agents of the 
        Department of Health and Human Services, (B) officers, 
        employees, or agents of schools with which the 
        Secretary has an agreement under this subpart, or (C) 
        any other person involved in the collection of a loan 
        under this subpart.
    (b) Statement Regarding Loan.--Each school shall, 
immediately prior to the graduation from such school of a 
student who receives a loan under this subpart after June 30, 
1986, provide such student with a statement specifying--
            (1) each amount borrowed by the student under this 
        subpart;
            (2) the total amount borrowed by the student under 
        this subpart; and
            (3) a schedule for the repayment of the amounts 
        borrowed under this subpart, including the number, 
        amount, and frequency of payments to be made.

SEC. 727. [292W] PROCEDURES FOR APPEAL OF TERMINATION OF AGREEMENTS.

    In any case in which the Secretary intends to terminate an 
agreement with a school under this subpart, the Secretary shall 
provide the school with a written notice specifying such 
intention and stating that the school may request a formal 
hearing with respect to such termination. If the school 
requests such a hearing within 30 days after the receipt of 
such notice, the Secretary shall provide such school with a 
hearing conducted by an administrative law judge.

SEC. 728. [292X] DISTRIBUTION OF ASSETS FROM LOAN FUNDS.

    (a) Distribution After Termination of Fund.--If a school 
terminates a loan fund established under an agreement pursuant 
to section 721(b), or if the Secretary for good cause 
terminates the agreement with the school, there shall be a 
capital distribution as follows:
            (1) The Secretary shall first be paid an amount 
        which bears the same ratio to such balance in such fund 
        on the date of termination of the fund as the total 
        amount of the Federal capital contributions to such 
        fund by the Secretary pursuant to section 721(b)(2)(A) 
        bears to the total amount in such fund derived from 
        such Federal capital contributions and from funds 
        deposited therein pursuant to section 721(b)(2)(B).
            (2) The remainder of such balance shall be paid to 
        the school.
    (b) Payment of Proportionate Share to Secretary.--If a 
capital distribution is made under subsection (a), the school 
involved shall, after the capital distribution, pay to the 
Secretary, not less often than quarterly, the same 
proportionate share of amounts received by the school in 
payment of principal or interest on loans made from the loan 
fund established pursuant to section 721(b) as was determined 
by the Secretary under subsection (a).

SEC. 735. \1\ [292Y] GENERAL PROVISIONS.
---------------------------------------------------------------------------

    \1\ Title VII does not have sections 729 through 734. See section 
102 of Public Law 102-408 (106 Stat. 1994, 2021).
---------------------------------------------------------------------------
    (a) Date Certain for Applications.--The Secretary shall 
from time to time set dates by which schools must file 
applications for Federal capital contributions.
    (b) Contingent Reduction in Allotments.--If the total of 
the amounts requested for any fiscal year in such applications 
exceeds the amounts appropriated under this section for that 
fiscal year, the allotment to the loan fund of each such school 
shall be reduced to whichever of the following is the smaller: 
(A) the amount requested in its application; or (B) an amount 
which bears the same ratio to the amounts appropriated as the 
number of students estimated by the Secretary to be enrolled in 
such school during such fiscal year bears to the estimated 
total number of students in all such schools during such year. 
Amounts remaining after allotment under the preceding sentence 
shall be reallotted in accordance with clause (B) of such 
sentence among schools whose applications requested more than 
the amounts so allotted to their loan funds, but with such 
adjustments as may be necessary to prevent the total allotted 
to any such school's loan fund from exceeding the total so 
requested by it.
    (c) Allotment of Excess Funds.--Funds available in any 
fiscal year for payment to schools under this subpart which are 
in excess of the amount appropriated pursuant to this section 
for that year shall be allotted among schools in such manner as 
the Secretary determines will best carry out the purposes of 
this subpart.
    (d) Payment of Installments to Schools.--Allotments to a 
loan fund of a school shall be paid to it from time to time in 
such installments as the Secretary determines will not result 
in unnecessary accumulations in the loan fund at such school.
    (e) Disposition of Funds Returned to Secretary.--
            (1) Expenditure for federal capital 
        contributions.--Subject to section 723(b)(5), any 
        amounts from student loan funds under section 721 that 
        are returned to the Secretary by health professions 
        schools shall be expended to make Federal capital 
        contributions to such funds.
            (2) Date certain for contributions.--Amounts 
        described in paragraph (1) that are returned to the 
        Secretary shall be obligated before the end of the 
        succeeding fiscal year.
            (3) Preference in making contributions.--In making 
        Federal capital contributions to student loans funds 
        under section 721 for a fiscal year from amounts 
        described in paragraph (1), the Secretary shall give 
        preference to health professions schools of the same 
        disciplines as the health professions schools returning 
        such amounts for the period during which the amounts 
        expended for such contributions were received by the 
        Secretary. Any such amounts that, prior to being so 
        returned, were available only for the purpose of loans 
        under this subpart to individuals from disadvantaged 
        backgrounds shall be available only for such purpose.
    (f) Funding for Certain Medical Schools.--
            (1) Authorization of appropriations.--For the 
        purpose of making Federal capital contributions to 
        student loan funds established under section 721 by 
        schools of medicine or osteopathic medicine, there is 
        authorized to be appropriated $10,000,000 for each of 
        the fiscal years 1994 through 1996.
            (2) Minimum requirements.--
                    (A) Subject to subparagraph (B), the 
                Secretary may make a Federal capital 
                contribution pursuant to paragraph (1) only if 
                the school of medicine or osteopathic medicine 
                involved meets the conditions described in 
                subparagraph (A) of section 723(b)(2) or the 
                conditions described in subparagraph (C) of 
                such section.
                    (B) For purposes of subparagraph (A), the 
                conditions referred to in such subparagraph 
                shall be applied with respect to graduates of 
                the school involved whose date of graduation 
                occurred approximately 3 years before June 30 
                of the fiscal year preceding the fiscal year 
                for which the Federal capital contribution 
                involved is made.

           PART B--HEALTH PROFESSIONS TRAINING FOR DIVERSITY

SEC. 736. [293] CENTERS OF EXCELLENCE.

    (a) In General.--The Secretary shall make grants to, and 
enter into contracts with, designated health professions 
schools described in subsection (c), and other public and 
nonprofit health or educational entities, for the purpose of 
assisting the schools in supporting programs of excellence in 
health professions education for under-represented minority 
individuals.
    (b) Required Use of Funds.--The Secretary may not make a 
grant under subsection (a) unless the designated health 
professions school involved agrees, subject to subsection 
(c)(1)(C), to expend the grant--
            (1) to develop a large competitive applicant pool 
        through linkages with institutions of higher education, 
        local school districts, and other community-based 
        entities and establish an education pipeline for health 
        professions careers;
            (2) to establish, strengthen, or expand programs to 
        enhance the academic performance of under-represented 
        minority students attending the school;
            (3) to improve the capacity of such school to 
        train, recruit, and retain under-represented minority 
        faculty including the payment of such stipends and 
        fellowships as the Secretary may determine appropriate;
            (4) to carry out activities to improve the 
        information resources, clinical education, curricula 
        and cultural competence of the graduates of the school, 
        as it relates to minority health issues;
            (5) to facilitate faculty and student research on 
        health issues particularly affecting under-represented 
        minority groups, including research on issues relating 
        to the delivery of health care;
            (6) to carry out a program to train students of the 
        school in providing health services to a significant 
        number of under-represented minority individuals 
        through training provided to such students at 
        community-based health facilities that--
                    (A) provide such health services; and
                    (B) are located at a site remote from the 
                main site of the teaching facilities of the 
                school; and
            (7) to provide stipends as the Secretary determines 
        appropriate, in amounts as the Secretary determines 
        appropriate.
    (c) Centers of Excellence.--
            (1) Designated schools.--
                    (A) In general.--The designated health 
                professions schools referred to in subsection 
                (a) are such schools that meet each of the 
                conditions specified in subparagraphs (B) and 
                (C), and that--
                            (i) meet each of the conditions 
                        specified in paragraph (2)(A);
                            (ii) meet each of the conditions 
                        specified in paragraph (3);
                            (iii) meet each of the conditions 
                        specified in paragraph (4); or
                            (iv) meet each of the conditions 
                        specified in paragraph (5).
                    (B) General conditions.--The conditions 
                specified in this subparagraph are that a 
                designated health professions school--
                            (i) has a significant number of 
                        under-represented minority individuals 
                        enrolled in the school, including 
                        individuals accepted for enrollment in 
                        the school;
                            (ii) has been effective in 
                        assisting under-represented minority 
                        students of the school to complete the 
                        program of education and receive the 
                        degree involved;
                            (iii) has been effective in 
                        recruiting under-represented minority 
                        individuals to enroll in and graduate 
                        from the school, including providing 
                        scholarships and other financial 
                        assistance to such individuals and 
                        encouraging under-represented minority 
                        students from all levels of the 
                        educational pipeline to pursue health 
                        professions careers; and
                            (iv) has made significant 
                        recruitment efforts to increase the 
                        number of under-represented minority 
                        individuals serving in faculty or 
                        administrative positions at the school.
                    (C) Consortium.--The condition specified in 
                this subparagraph is that, in accordance with 
                subsection (e)(1), the designated health 
                profession school involved has with other 
                health profession schools (designated or 
                otherwise) formed a consortium to carry out the 
                purposes described in subsection (b) at the 
                schools of the consortium.
                    (D) Application of criteria to other 
                programs.--In the case of any criteria 
                established by the Secretary for purposes of 
                determining whether schools meet the conditions 
                described in subparagraph (B), this section may 
                not, with respect to racial and ethnic 
                minorities, be construed to authorize, require, 
                or prohibit the use of such criteria in any 
                program other than the program established in 
                this section.
            (2) Centers of excellence at certain historically 
        black colleges and universities.--
                    (A) Conditions.--The conditions specified 
                in this subparagraph are that a designated 
                health professions school--
                            (i) is a school described in 
                        section 799B(1); and
                            (ii) received a contract under 
                        section 788B for fiscal year 1987, as 
                        such section was in effect for such 
                        fiscal year.
                    (B) Use of grant.--In addition to the 
                purposes described in subsection (b), a grant 
                under subsection (a) to a designated health 
                professions school meeting the conditions 
                described in subparagraph (A) may be expended--
                            (i) to develop a plan to achieve 
                        institutional improvements, including 
                        financial independence, to enable the 
                        school to support programs of 
                        excellence in health professions 
                        education for under-represented 
                        minority individuals; and
                            (ii) to provide improved access to 
                        the library and informational resources 
                        of the school.
                    (C) Exception.--The requirements of 
                paragraph (1)(C) shall not apply to a 
                historically black college or university that 
                receives funding under paragraphs (2) or (5) 
                \1\.
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    \1\ So in law. Probably should read ``paragraph (2) or (5)''.
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            (3) Hispanic centers of excellence.--The conditions 
        specified in this paragraph are that--
                    (A) with respect to Hispanic individuals, 
                each of clauses (i) through (iv) of paragraph 
                (1)(B) applies to the designated health 
                professions school involved;
                    (B) the school agrees, as a condition of 
                receiving a grant under subsection (a), that 
                the school will, in carrying out the duties 
                described in subsection (b), give priority to 
                carrying out the duties with respect to 
                Hispanic individuals; and
                    (C) the school agrees, as a condition of 
                receiving a grant under subsection (a), that--
                            (i) the school will establish an 
                        arrangement with 1 or more public or 
                        nonprofit community based Hispanic 
                        serving organizations, or public or 
                        nonprofit private institutions of 
                        higher education, including schools of 
                        nursing, whose enrollment of students 
                        has traditionally included a 
                        significant number of Hispanic 
                        individuals, the purposes of which will 
                        be to carry out a program--
                                    (I) to identify Hispanic 
                                students who are interested in 
                                a career in the health 
                                profession involved; and
                                    (II) to facilitate the 
                                educational preparation of such 
                                students to enter the health 
                                professions school; and
                            (ii) the school will make efforts 
                        to recruit Hispanic students, including 
                        students who have participated in the 
                        undergraduate or other matriculation 
                        program carried out under arrangements 
                        established by the school pursuant to 
                        clause (i)(II) and will assist Hispanic 
                        students regarding the completion of 
                        the educational requirements for a 
                        degree from the school.
            (4) Native american centers of excellence.--Subject 
        to subsection (e), the conditions specified in this 
        paragraph are that--
                    (A) with respect to Native Americans, each 
                of clauses (i) through (iv) of paragraph (1)(B) 
                applies to the designated health professions 
                school involved;
                    (B) the school agrees, as a condition of 
                receiving a grant under subsection (a), that 
                the school will, in carrying out the duties 
                described in subsection (b), give priority to 
                carrying out the duties with respect to Native 
                Americans; and
                    (C) the school agrees, as a condition of 
                receiving a grant under subsection (a), that--
                            (i) the school will establish an 
                        arrangement with 1 or more public or 
                        nonprofit private institutions of 
                        higher education, including schools of 
                        nursing, whose enrollment of students 
                        has traditionally included a 
                        significant number of Native Americans, 
                        the purpose of which arrangement will 
                        be to carry out a program--
                                    (I) to identify Native 
                                American students, from the 
                                institutions of higher 
                                education referred to in clause 
                                (i), who are interested in 
                                health professions careers; and
                                    (II) to facilitate the 
                                educational preparation of such 
                                students to enter the 
                                designated health professions 
                                school; and
                            (ii) the designated health 
                        professions school will make efforts to 
                        recruit Native American students, 
                        including students who have 
                        participated in the undergraduate 
                        program carried out under arrangements 
                        established by the school pursuant to 
                        clause (i) and will assist Native 
                        American students regarding the 
                        completion of the educational 
                        requirements for a degree from the 
                        designated health professions school.
            (5) Other centers of excellence.--The conditions 
        specified in this paragraph are--
                    (A) with respect to other centers of 
                excellence, the conditions described in clauses 
                (i) through (iv) of paragraph (1)(B); and
                    (B) that the health professions school 
                involved has an enrollment of under-represented 
                minorities above the national average for such 
                enrollments of health professions schools.
    (d) Designation as Center of Excellence.--
            (1) In general.--Any designated health professions 
        school receiving a grant under subsection (a) and 
        meeting the conditions described in paragraph (2) or 
        (5) of subsection (c) shall, for purposes of this 
        section, be designated by the Secretary as a Center of 
        Excellence in Under-Represented Minority Health 
        Professions Education.
            (2) Hispanic centers of excellence.--Any designated 
        health professions school receiving a grant under 
        subsection (a) and meeting the conditions described in 
        subsection (c)(3) shall, for purposes of this section, 
        be designated by the Secretary as a Hispanic Center of 
        Excellence in Health Professions Education.
            (3) Native american centers of excellence.--Any 
        designated health professions school receiving a grant 
        under subsection (a) and meeting the conditions 
        described in subsection (c)(4) shall, for purposes of 
        this section, be designated by the Secretary as a 
        Native American Center of Excellence in Health 
        Professions Education. Any consortium receiving such a 
        grant pursuant to subsection (e) shall, for purposes of 
        this section, be so designated.
    (e) Authority Regarding Native American Centers of 
Excellence.--With respect to meeting the conditions specified 
in subsection (c)(4), the Secretary may make a grant under 
subsection (a) to a designated health professions school that 
does not meet such conditions if--
            (1) the school has formed a consortium in 
        accordance with subsection (d)(1); and
            (2) the schools of the consortium collectively meet 
        such conditions, without regard to whether the schools 
        individually meet such conditions.
    (f) Duration of Grant.--The period during which payments 
are made under a grant under subsection (a) may not exceed 5 
years. Such payments shall be subject to annual approval by the 
Secretary and to the availability of appropriations for the 
fiscal year involved to make the payments.
    (g) Definitions.--In this section:
            (1) Designated health professions school.--
                    (A) In general.--The term ``health 
                professions school'' means, except as provided 
                in subparagraph (B), a school of medicine, a 
                school of osteopathic medicine, a school of 
                dentistry, a school of pharmacy, or a graduate 
                program in behavioral or mental health.
                    (B) Exception.--The definition established 
                in subparagraph (A) shall not apply to the use 
                of the term ``designated health professions 
                school'' for purposes of subsection (c)(2).
            (2) Program of excellence.--The term ``program of 
        excellence'' means any program carried out by a 
        designated health professions school with a grant made 
        under subsection (a), if the program is for purposes 
        for which the school involved is authorized in 
        subsection (b) or (c) to expend the grant.
            (3) Native americans.--The term ``Native 
        Americans'' means American Indians, Alaskan Natives, 
        Aleuts, and Native Hawaiians.
    (h) Formula for Allocations.--
            (1) Allocations.--Based on the amount appropriated 
        under subsection (i) for a fiscal year, the following 
        subparagraphs shall apply as appropriate:
                    (A) In general.--If the amounts 
                appropriated under subsection (i) for a fiscal 
                year are $24,000,000 or less--
                            (i) the Secretary shall make 
                        available $12,000,000 for grants under 
                        subsection (a) to health professions 
                        schools that meet the conditions 
                        described in subsection (c)(2)(A); and
                            (ii) and available after grants are 
                        made with funds under clause (i), the 
                        Secretary shall make available--
                                    (I) 60 percent of such 
                                amount for grants under 
                                subsection (a) to health 
                                professions schools that meet 
                                the conditions described in 
                                paragraph (3) or (4) of 
                                subsection (c) (including 
                                meeting the conditions under 
                                subsection (e)); and
                                    (II) 40 percent of such 
                                amount for grants under 
                                subsection (a) to health 
                                professions schools that meet 
                                the conditions described in 
                                subsection (c)(5).
                    (B) Funding in excess of $24,000,000.--If 
                amounts appropriated under subsection (i) for a 
                fiscal year exceed $24,000,000 but are less 
                than $30,000,000--
                            (i) 80 percent of such excess 
                        amounts shall be made available for 
                        grants under subsection (a) to health 
                        professions schools that meet the 
                        requirements described in paragraph (3) 
                        or (4) of subsection (c) (including 
                        meeting conditions pursuant to 
                        subsection (e)); and
                            (ii) 20 percent of such excess 
                        amount shall be made available for 
                        grants under subsection (a) to health 
                        professions schools that meet the 
                        conditions described in subsection 
                        (c)(5).
                    (C) Funding in excess of $30,000,000.--If 
                amounts appropriated under subsection (i) for a 
                fiscal year exceed $30,000,000 but are less 
                than $40,000,000, the Secretary shall make 
                available--
                            (i) not less than $12,000,000 for 
                        grants under subsection (a) to health 
                        professions schools that meet the 
                        conditions described in subsection 
                        (c)(2)(A);
                            (ii) not less than $12,000,000 for 
                        grants under subsection (a) to health 
                        professions schools that meet the 
                        conditions described in paragraph (3) 
                        or (4) of subsection (c) (including 
                        meeting conditions pursuant to 
                        subsection (e));
                            (iii) not less than $6,000,000 for 
                        grants under subsection (a) to health 
                        professions schools that meet the 
                        conditions described in subsection 
                        (c)(5); and
                            (iv) after grants are made with 
                        funds under clauses (i) through (iii), 
                        any remaining excess amount for grants 
                        under subsection (a) to health 
                        professions schools that meet the 
                        conditions described in paragraph 
                        (2)(A), (3), (4), or (5) of subsection 
                        (c).
                    (D) Funding in excess of $40,000,000.--If 
                amounts appropriated under subsection (i) for a 
                fiscal year are $40,000,000 or more, the 
                Secretary shall make available--
                            (i) not less than $16,000,000 for 
                        grants under subsection (a) to health 
                        professions schools that meet the 
                        conditions described in subsection 
                        (c)(2)(A);
                            (ii) not less than $16,000,000 for 
                        grants under subsection (a) to health 
                        professions schools that meet the 
                        conditions described in paragraph (3) 
                        or (4) of subsection (c) (including 
                        meeting conditions pursuant to 
                        subsection (e));
                            (iii) not less than $8,000,000 for 
                        grants under subsection (a) to health 
                        professions schools that meet the 
                        conditions described in subsection 
                        (c)(5); and
                            (iv) after grants are made with 
                        funds under clauses (i) through (iii), 
                        any remaining funds for grants under 
                        subsection (a) to health professions 
                        schools that meet the conditions 
                        described in paragraph (2)(A), (3), 
                        (4), or (5) of subsection (c).
            (2) No limitation.--Nothing in this subsection 
        shall be construed as limiting the centers of 
        excellence referred to in this section to the 
        designated amount, or to preclude such entities from 
        competing for grants under this section.
            (3) Maintenance of effort.--
                    (A) In general.--With respect to activities 
                for which a grant made under this part are 
                authorized to be expended, the Secretary may 
                not make such a grant to a center of excellence 
                for any fiscal year unless the center agrees to 
                maintain expenditures of non-Federal amounts 
                for such activities at a level that is not less 
                than the level of such expenditures maintained 
                by the center for the fiscal year preceding the 
                fiscal year for which the school receives such 
                a grant.
                    (B) Use of federal funds.--With respect to 
                any Federal amounts received by a center of 
                excellence and available for carrying out 
                activities for which a grant under this part is 
                authorized to be expended, the center shall, 
                before expending the grant, expend the Federal 
                amounts obtained from sources other than the 
                grant, unless given prior approval from the 
                Secretary.
    (i) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section--
            (1) $50,000,000 for each of the fiscal years 2010 
        through 2015; and
            (2) and such sums as are necessary for each 
        subsequent fiscal year.

SEC. 737. [293A] SCHOLARSHIPS FOR DISADVANTAGED STUDENTS.

    (a) In General.--The Secretary may make a grant to an 
eligible entity (as defined in subsection (d)(1)) under this 
section for the awarding of scholarships by schools to any 
full-time student who is an eligible individual as defined in 
subsection (d). Such scholarships may be expended only for 
tuition expenses, other reasonable educational expenses, and 
reasonable living expenses incurred in the attendance of such 
school.
    (b) Preference in Providing Scholarships.--The Secretary 
may not make a grant to an entity under subsection (a) unless 
the health professions and nursing schools involved agree that, 
in providing scholarships pursuant to the grant, the schools 
will give preference to students for whom the costs of 
attending the schools would constitute a severe financial 
hardship and, notwithstanding other provisions of this section, 
to former recipients of scholarships under sections 736 and 
740(d)(2)(B) (as such sections existed on the day before the 
date of enactment of this section).
    (c) Amount of Award.--In awarding grants to eligible 
entities that are health professions and nursing schools, the 
Secretary shall give priority to eligible entities based on the 
proportion of graduating students going into primary care, the 
proportion of underrepresented minority students, and the 
proportion of graduates working in medically underserved 
communities.
    (d) Definitions.--In this section:
            (1) Eligible entities.--The term ``eligible 
        entities'' means an entity that--
                    (A) is a school of medicine, osteopathic 
                medicine, dentistry, nursing (as defined in 
                section 801), pharmacy, podiatric medicine, 
                optometry, veterinary medicine, public health, 
                chiropractic, or allied health, a school 
                offering a graduate program in behavioral and 
                mental health practice, or an entity providing 
                programs for the training of physician 
                assistants; and
                    (B) is carrying out a program for 
                recruiting and retaining students from 
                disadvantaged backgrounds, including students 
                who are members of racial and ethnic minority 
                groups.
            (2) Eligible individual.--The term ``eligible 
        individual'' means an individual who--
                    (A) is from a disadvantaged background;
                    (B) has a financial need for a scholarship; 
                and
                    (C) is enrolled (or accepted for 
                enrollment) at an eligible health professions 
                or nursing school as a full-time student in a 
                program leading to a degree in a health 
                profession or nursing.

SEC. 738. [293B] LOAN REPAYMENTS AND FELLOWSHIPS REGARDING FACULTY 
                    POSITIONS.

    (a) Loan Repayments.--
            (1) Establishment of program.--The Secretary shall 
        establish a program of entering into contracts with 
        individuals described in paragraph (2) under which the 
        individuals agree to serve as members of the faculties 
        of schools described in paragraph (3) in consideration 
        of the Federal Government agreeing to pay, for each 
        year of such service, not more than $30,000 of the 
        principal and interest of the educational loans of such 
        individuals.
            (2) Eligible individuals.--The individuals referred 
        to in paragraph (1) are individuals from disadvantaged 
        backgrounds who--
                    (A) have a degree in medicine, osteopathic 
                medicine, dentistry, nursing, or another health 
                profession;
                    (B) are enrolled in an approved graduate 
                training program in medicine, osteopathic 
                medicine, dentistry, nursing, or other health 
                profession; or
                    (C) are enrolled as full-time students--
                            (i) in an accredited (as determined 
                        by the Secretary) school described in 
                        paragraph (3); and
                            (ii) in the final year of a course 
                        of a study or program, offered by such 
                        institution and approved by the 
                        Secretary, leading to a degree from 
                        such a school.
            (3) Eligible health professions schools.--The 
        schools described in this paragraph are schools of 
        medicine, nursing (as schools of nursing are defined in 
        section 801), osteopathic medicine, dentistry, 
        pharmacy, allied health, podiatric medicine, optometry, 
        veterinary medicine, or public health, schools offering 
        physician assistant education programs, or schools 
        offering graduate programs in behavioral and mental 
        health.
            (4) Requirements regarding faculty positions.--The 
        Secretary may not enter into a contract under paragraph 
        (1) unless--
                    (A) the individual involved has entered 
                into a contract with a school described in 
                paragraph (3) to serve as a member of the 
                faculty of the school for not less than 2 
                years; and
                    (B) the contract referred to in 
                subparagraph (A) provides that--
                            (i) the school will, for each year 
                        for which the individual will serve as 
                        a member of the faculty under the 
                        contract with the school, make payments 
                        of the principal and interest due on 
                        the educational loans of the individual 
                        for such year in an amount equal to the 
                        amount of such payments made by the 
                        Secretary for the year;
                            (ii) the payments made by the 
                        school pursuant to clause (i) on behalf 
                        of the individual will be in addition 
                        to the pay that the individual would 
                        otherwise receive for serving as a 
                        member of such faculty; and
                            (iii) the school, in making a 
                        determination of the amount of 
                        compensation to be provided by the 
                        school to the individual for serving as 
                        a member of the faculty, will make the 
                        determination without regard to the 
                        amount of payments made (or to be made) 
                        to the individual by the Federal 
                        Government under paragraph (1).
            (5) Applicability of certain provisions.--The 
        provisions of sections 338C, 338G, and 338I shall apply 
        to the program established in paragraph (1) to the same 
        extent and in the same manner as such provisions apply 
        to the National Health Service Corps Loan Repayment 
        Program established in subpart III of part D of title 
        III, including the applicability of provisions 
        regarding reimbursements for increased tax liability 
        and regarding bankruptcy.
            (6) Waiver regarding school contributions.--The 
        Secretary may waive the requirement established in 
        paragraph (4)(B) if the Secretary determines that the 
        requirement will impose an undue financial hardship on 
        the school involved.
    (b) Fellowships.--
            (1) In general.--The Secretary may make grants to 
        and enter into contracts with eligible entities to 
        assist such entities in increasing the number of 
        underrepresented minority individuals who are members 
        of the faculty of such schools.
            (2) Applications.--To be eligible to receive a 
        grant or contract under this subsection, an entity 
        shall provide an assurance, in the application 
        submitted by the entity, that--
                    (A) amounts received under such a grant or 
                contract will be used to award a fellowship to 
                an individual only if the individual meets the 
                requirements of paragraphs (3) and (4); and
                    (B) each fellowship awarded pursuant to the 
                grant or contract will include--
                            (i) a stipend in an amount not 
                        exceeding 50 percent of the regular 
                        salary of a similar faculty member for 
                        not to exceed 3 years of training; and
                            (ii) an allowance for other 
                        expenses, such as travel to 
                        professional meetings and costs related 
                        to specialized training.
            (3) Eligibility.--To be eligible to receive a grant 
        or contract under paragraph (1), an applicant shall 
        demonstrate to the Secretary that such applicant has or 
        will have the ability to--
                    (A) identify, recruit and select 
                underrepresented minority individuals who have 
                the potential for teaching, administration, or 
                conducting research at a health professions 
                institution;
                    (B) provide such individuals with the 
                skills necessary to enable them to secure a 
                tenured faculty position at such institution, 
                which may include training with respect to 
                pedagogical skills, program administration, the 
                design and conduct of research, grants writing, 
                and the preparation of articles suitable for 
                publication in peer reviewed journals;
                    (C) provide services designed to assist 
                such individuals in their preparation for an 
                academic career, including the provision of 
                counselors; and
                    (D) provide health services to rural or 
                medically underserved populations.
            (4) Requirements.--To be eligible to receive a 
        grant or contract under paragraph (1) an applicant 
        shall--
                    (A) provide an assurance that such 
                applicant will make available (directly through 
                cash donations) $1 for every $1 of Federal 
                funds received under this section for the 
                fellowship;
                    (B) provide an assurance that institutional 
                support will be provided for the individual for 
                the second and third years at a level that is 
                equal to the total amount of institutional 
                funds provided in the year in which the grant 
                or contract was awarded;
                    (C) provide an assurance that the 
                individual that will receive the fellowship 
                will be a member of the faculty of the 
                applicant school; and
                    (D) provide an assurance that the 
                individual that will receive the fellowship 
                will have, at a minimum, appropriate advanced 
                preparation (such as a master's or doctoral 
                degree) and special skills necessary to enable 
                such individual to teach and practice.
            (5) Definition.--For purposes of this subsection, 
        the term ``underrepresented minority individuals'' 
        means individuals who are members of racial or ethnic 
        minority groups that are underrepresented in the health 
        professions including nursing.

SEC. 739. [293C] EDUCATIONAL ASSISTANCE IN THE HEALTH PROFESSIONS 
                    REGARDING INDIVIDUALS FROM DISADVANTAGED 
                    BACKGROUNDS.

    (a) In General.--
            (1) Authority for grants.--For the purpose of 
        assisting individuals from disadvantaged backgrounds, 
        as determined in accordance with criteria prescribed by 
        the Secretary, to undertake education to enter a health 
        profession, the Secretary may make grants to and enter 
        into contracts with schools of medicine, osteopathic 
        medicine, public health, dentistry, veterinary 
        medicine, optometry, pharmacy, allied health, 
        chiropractic, and podiatric medicine, public and 
        nonprofit private schools that offer graduate programs 
        in behavioral and mental health, programs for the 
        training of physician assistants, and other public or 
        private nonprofit health or educational entities to 
        assist in meeting the costs described in paragraph (2).
            (2) Authorized expenditures.--A grant or contract 
        under paragraph (1) may be used by the entity to meet 
        the cost of--
                    (A) identifying, recruiting, and selecting 
                individuals from disadvantaged backgrounds, as 
                so determined, for education and training in a 
                health profession;
                    (B) facilitating the entry of such 
                individuals into such a school;
                    (C) providing counseling, mentoring, or 
                other services designed to assist such 
                individuals to complete successfully their 
                education at such a school;
                    (D) providing, for a period prior to the 
                entry of such individuals into the regular 
                course of education of such a school, 
                preliminary education and health research 
                training designed to assist them to complete 
                successfully such regular course of education 
                at such a school, or referring such individuals 
                to institutions providing such preliminary 
                education;
                    (E) publicizing existing sources of 
                financial aid available to students in the 
                education program of such a school or who are 
                undertaking training necessary to qualify them 
                to enroll in such a program;
                    (F) paying such scholarships as the 
                Secretary may determine for such individuals 
                for any period of health professions education 
                at a health professions school;
                    (G) paying such stipends as the Secretary 
                may approve for such individuals for any period 
                of education in student-enhancement programs 
                (other than regular courses), except that such 
                a stipend may not be provided to an individual 
                for more than 12 months, and such a stipend 
                shall be in an amount determined appropriate by 
                the Secretary (notwithstanding any other 
                provision of law regarding the amount of 
                stipends);
                    (H) carrying out programs under which such 
                individuals gain experience regarding a career 
                in a field of primary health care through 
                working at facilities of public or private 
                nonprofit community-based providers of primary 
                health services; and
                    (I) conducting activities to develop a 
                larger and more competitive applicant pool 
                through partnerships with institutions of 
                higher education, school districts, and other 
                community-based entities.
            (3) Definition.--In this section, the term 
        ``regular course of education of such a school'' as 
        used in subparagraph (D) includes a graduate program in 
        behavioral or mental health.
    (b) Requirements for Awards.--In making awards to eligible 
entities under subsection (a)(1), the Secretary shall give 
preference to approved applications for programs that involve a 
comprehensive approach by several public or nonprofit private 
health or educational entities to establish, enhance and expand 
educational programs that will result in the development of a 
competitive applicant pool of individuals from disadvantaged 
backgrounds who desire to pursue health professions careers. In 
considering awards for such a comprehensive partnership 
approach, the following shall apply with respect to the entity 
involved:
            (1) The entity shall have a demonstrated commitment 
        to such approach through formal agreements that have 
        common objectives with institutions of higher 
        education, school districts, and other community-based 
        entities.
            (2) Such formal agreements shall reflect the 
        coordination of educational activities and support 
        services, increased linkages, and the consolidation of 
        resources within a specific geographic area.
            (3) The design of the educational activities 
        involved shall provide for the establishment of a 
        competitive health professions applicant pool of 
        individuals from disadvantaged backgrounds by enhancing 
        the total preparation (academic and social) of such 
        individuals to pursue a health professions career.
            (4) The programs or activities under the award 
        shall focus on developing a culturally competent health 
        care workforce that will serve the unserved and 
        underserved populations within the geographic area.
    (c) Equitable Allocation of Financial Assistance.--The 
Secretary, to the extent practicable, shall ensure that 
services and activities under subsection (a) are adequately 
allocated among the various racial and ethnic populations who 
are from disadvantaged backgrounds.
    (d) Matching Requirements.--The Secretary may require that 
an entity that applies for a grant or contract under subsection 
(a), provide non-Federal matching funds, as appropriate, to 
ensure the institutional commitment of the entity to the 
projects funded under the grant or contract. As determined by 
the Secretary, such non-Federal matching funds may be provided 
directly or through donations from public or private entities 
and may be in cash or in-kind, fairly evaluated, including 
plant, equipment, or services.

SEC. 740. [293D] AUTHORIZATION OF APPROPRIATION.

    (a) Scholarships.--There are authorized to be appropriated 
to carry out section 737, $51,000,000 for fiscal year 2010, and 
such sums as may be necessary for each of the fiscal years 2011 
through 2014. Of the amount appropriated in any fiscal year, 
the Secretary shall ensure that not less than 16 percent shall 
be distributed to schools of nursing.
    (b) Loan Repayments and Fellowships.--For the purpose of 
carrying out section 738, there is authorized to be 
appropriated, $5,000,000 for each of the fiscal years 2010 
through 2014.
    (c) Educational Assistance in Health Professions Regarding 
Individuals for Disadvantaged Backgrounds.--For the purpose of 
grants and contracts under section 739(a)(1), there is 
authorized to be appropriated $60,000,000 for fiscal year 2010 
and such sums as may be necessary for each of the fiscal years 
2011 through 2014. The Secretary may use not to exceed 20 
percent of the amount appropriated for a fiscal year under this 
subsection to provide scholarships under section 739(a)(2)(F).
    (d) Report.--Not later than 6 months after the date of 
enactment of this part, the Secretary shall prepare and submit 
to the appropriate committees of Congress a report concerning 
the efforts of the Secretary to address the need for a 
representative mix of individuals from historically minority 
health professions schools, or from institutions or other 
entities that historically or by geographic location have a 
demonstrated record of training or educating underrepresented 
minorities, within various health professions disciplines, on 
peer review councils.

SEC. 741. [293E] GRANTS FOR HEALTH PROFESSIONS EDUCATION.

    (a) Cultural Competency, Prevention, and Public Health and 
Individuals With Disability Grants.--
            (1) In general.--The Secretary, acting through the 
        Administrator of the Health Resources and Services 
        Administration, may make awards of grants, contracts, 
        or cooperative agreements to public and nonprofit 
        private entities (including tribal entities) for the 
        development, evaluation, and dissemination of research, 
        demonstration projects, and model curricula for 
        cultural competency, prevention, public health 
        proficiency, reducing health disparities, and aptitude 
        for working with individuals with disabilities training 
        for use in health professions schools and continuing 
        education programs, and for other purposes determined 
        as appropriate by the Secretary.
            (2) Eligible entities.--Unless specifically 
        required otherwise in this title, the Secretary shall 
        accept applications for grants or contracts under this 
        section from health professions schools, academic 
        health centers, State or local governments, or other 
        appropriate public or private nonprofit entities (or 
        consortia of entities, including entities promoting 
        multidisciplinary approaches) for funding and 
        participation in health professions training 
        activities. The Secretary may accept applications from 
        for-profit private entities as determined appropriate 
        by the Secretary.
    (b) Collaboration.--In carrying out subsection (a), the 
Secretary shall collaborate with health professional societies, 
licensing and accreditation entities, health professions 
schools, and experts in minority health and cultural 
competency, prevention, and public health and disability 
groups, community-based organizations, and other organizations 
as determined appropriate by the Secretary. The Secretary shall 
coordinate with curricula and research and demonstration 
projects developed under section 807.
    (c) Dissemination.--
            (1) In general.--Model curricula developed under 
        this section shall be disseminated through the Internet 
        Clearinghouse under section 270 and such other means as 
        determined appropriate by the Secretary.
            (2) Evaluation.--The Secretary shall evaluate the 
        adoption and the implementation of cultural competency, 
        prevention, and public health, and working with 
        individuals with a disability training curricula, and 
        the facilitate inclusion of these competency measures 
        in quality measurement systems as appropriate.
    (d) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section such sums as may 
be necessary for each of fiscal years 2010 through 2015.

PART C--TRAINING IN FAMILY MEDICINE, GENERAL INTERNAL MEDICINE, GENERAL 
  PEDIATRICS, PHYSICIAN ASSISTANTS, GENERAL DENTISTRY, AND PEDIATRIC 
                               DENTISTRY

                 Subpart I--Medical Training Generally

SEC. 747. [293K] PRIMARY CARE TRAINING AND ENHANCEMENT.

    (a) Support and Development of Primary Care Training 
Programs.--
            (1) In general.--The Secretary may make grants to, 
        or enter into contracts with, an accredited public or 
        nonprofit private hospital, school of medicine or 
        osteopathic medicine, academically affiliated physician 
        assistant training program, or a public or private 
        nonprofit entity which the Secretary has determined is 
        capable of carrying out such grant or contract--
                    (A) to plan, develop, operate, or 
                participate in an accredited professional 
                training program, including an accredited 
                residency or internship program in the field of 
                family medicine, general internal medicine, or 
                general pediatrics for medical students, 
                interns, residents, or practicing physicians as 
                defined by the Secretary;
                    (B) to provide need-based financial 
                assistance in the form of traineeships and 
                fellowships to medical students, interns, 
                residents, practicing physicians, or other 
                medical personnel, who are participants in any 
                such program, and who plan to specialize or 
                work in the practice of the fields defined in 
                subparagraph (A);
                    (C) to plan, develop, and operate a program 
                for the training of physicians who plan to 
                teach in family medicine, general internal 
                medicine, or general pediatrics training 
                programs;
                    (D) to plan, develop, and operate a program 
                for the training of physicians teaching in 
                community-based settings;
                    (E) to provide financial assistance in the 
                form of traineeships and fellowships to 
                physicians who are participants in any such 
                programs and who plan to teach or conduct 
                research in a family medicine, general internal 
                medicine, or general pediatrics training 
                program;
                    (F) to plan, develop, and operate a 
                physician assistant education program, and for 
                the training of individuals who will teach in 
                programs to provide such training;
                    (G) to plan, develop, and operate a 
                demonstration program that provides training in 
                new competencies, as recommended by the 
                Advisory Committee on Training in Primary Care 
                Medicine and Dentistry and the National Health 
                Care Workforce Commission established in 
                section 5101 of the Patient Protection and 
                Affordable Care Act, which may include--
                            (i) providing training to primary 
                        care physicians relevant to providing 
                        care through patient-centered medical 
                        homes (as defined by the Secretary for 
                        purposes of this section);
                            (ii) developing tools and curricula 
                        relevant to patient-centered medical 
                        homes; and
                            (iii) providing continuing 
                        education to primary care physicians 
                        relevant to patient-centered medical 
                        homes; and
                    (H) to plan, develop, and operate joint 
                degree programs to provide interdisciplinary 
                and interprofessional graduate training in 
                public health and other health professions to 
                provide training in environmental health, 
                infectious disease control, disease prevention 
                and health promotion, epidemiological studies 
                and injury control.
            (2) Duration of awards.--The period during which 
        payments are made to an entity from an award of a grant 
        or contract under this subsection shall be 5 years.
    (b) Capacity Building in Primary Care.--
            (1) In general.--The Secretary may make grants to 
        or enter into contracts with accredited schools of 
        medicine or osteopathic medicine to establish, 
        maintain, or improve--
                    (A) academic units or programs that improve 
                clinical teaching and research in fields 
                defined in subsection (a)(1)(A); or
                    (B) programs that integrate academic 
                administrative units in fields defined in 
                subsection (a)(1)(A) to enhance 
                interdisciplinary recruitment, training, and 
                faculty development.
            (2) Preference in making awards under this 
        subsection.--In making awards of grants and contracts 
        under paragraph (1), the Secretary shall give 
        preference to any qualified applicant for such an award 
        that agrees to expend the award for the purpose of--
                    (A) establishing academic units or programs 
                in fields defined in subsection (a)(1)(A); or
                    (B) substantially expanding such units or 
                programs.
            (3) Priorities in making awards.--In awarding 
        grants or contracts under paragraph (1), the Secretary 
        shall give priority to qualified applicants that--
                    (A) proposes a collaborative project 
                between academic administrative units of 
                primary care;
                    (B) proposes innovative approaches to 
                clinical teaching using models of primary care, 
                such as the patient centered medical home, team 
                management of chronic disease, and 
                interprofessional integrated models of health 
                care that incorporate transitions in health 
                care settings and integration physical and 
                mental health provision;
                    (C) have a record of training the greatest 
                percentage of providers, or that have 
                demonstrated significant improvements in the 
                percentage of providers trained, who enter and 
                remain in primary care practice;
                    (D) have a record of training individuals 
                who are from underrepresented minority groups 
                or from a rural or disadvantaged background;
                    (E) provide training in the care of 
                vulnerable populations such as children, older 
                adults, homeless individuals, victims of abuse 
                or trauma, individuals with mental health or 
                substance-related disorders, individuals with 
                HIV/AIDS, and individuals with disabilities;
                    (F) establish formal relationships and 
                submit joint applications with federally 
                qualified health centers, rural health clinics, 
                area health education centers, or clinics 
                located in underserved areas or that serve 
                underserved populations;
                    (G) teach trainees the skills to provide 
                interprofessional, integrated care through 
                collaboration among health professionals;
                    (H) provide training in enhanced 
                communication with patients, evidence-based 
                practice, chronic disease management, 
                preventive care, health information technology, 
                or other competencies as recommended by the 
                Advisory Committee on Training in Primary Care 
                Medicine and Dentistry and the National Health 
                Care Workforce Commission established in 
                section 5101 of the Patient Protection and 
                Affordable Care Act; or
                    (I) provide training in cultural competency 
                and health literacy.
            (4) Duration of awards.--The period during which 
        payments are made to an entity from an award of a grant 
        or contract under this subsection shall be 5 years.
    (c) Authorization of Appropriations.--
            (1) In general.--For purposes of carrying out this 
        section (other than subsection (b)(1)(B)), there are 
        authorized to be appropriated $125,000,000 for fiscal 
        year 2010, and such sums as may be necessary for each 
        of fiscal years 2011 through 2014.
            (2) Training programs.--Fifteen percent of the 
        amount appropriated pursuant to paragraph (1) in each 
        such fiscal year shall be allocated to the physician 
        assistant training programs described in subsection 
        (a)(1)(F), which prepare students for practice in 
        primary care.
            (3) Integrating academic administrative units.--For 
        purposes of carrying out subsection (b)(1)(B), there 
        are authorized to be appropriated $750,000 for each of 
        fiscal years 2010 through 2014.

SEC. 747A. [293K-1] TRAINING OPPORTUNITIES FOR DIRECT CARE WORKERS.

    (a) In General.--The Secretary shall award grants to 
eligible entities to enable such entities to provide new 
training opportunities for direct care workers who are employed 
in long-term care settings such as nursing homes (as defined in 
section 1908(e)(1) of the Social Security Act (42 U.S.C. 
1396g(e)(1)), assisted living facilities and skilled nursing 
facilities, intermediate care facilities for individuals with 
mental retardation, home and community based settings, and any 
other setting the Secretary determines to be appropriate.
    (b) Eligibility.--To be eligible to receive a grant under 
this section, an entity shall--
            (1) be an institution of higher education (as 
        defined in section 102 of the Higher Education Act of 
        1965 (20 U.S.C. 1002)) that--
                    (A) is accredited by a nationally 
                recognized accrediting agency or association 
                listed under section 101(c) of the Higher 
                Education Act of 1965 (20 U.S.C. 1001(c)); and
                    (B) has established a public-private 
                educational partnership with a nursing home or 
                skilled nursing facility, agency or entity 
                providing home and community based services to 
                individuals with disabilities, or other long-
                term care provider; and
            (2) submit to the Secretary an application at such 
        time, in such manner, and containing such information 
        as the Secretary may require.
    (c) Use of Funds.--An eligible entity shall use amounts 
awarded under a grant under this section to provide assistance 
to eligible individuals to offset the cost of tuition and 
required fees for enrollment in academic programs provided by 
such entity.
    (d) Eligible Individual.--
            (1) Eligibility.--To be eligible for assistance 
        under this section, an individual shall be enrolled in 
        courses provided by a grantee under this subsection and 
        maintain satisfactory academic progress in such 
        courses.
            (2) Condition of assistance.--As a condition of 
        receiving assistance under this section, an individual 
        shall agree that, following completion of the 
        assistance period, the individual will work in the 
        field of geriatrics, disability services, long term 
        services and supports, or chronic care management for a 
        minimum of 2 years under guidelines set by the 
        Secretary.
    (e) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section, $10,000,000 for 
the period of fiscal years 2011 through 2013.

SEC. 748. [293K-2] TRAINING IN GENERAL, PEDIATRIC, AND PUBLIC HEALTH 
                    DENTISTRY.

    (a) Support and Development of Dental Training Programs.--
            (1) In general.--The Secretary may make grants to, 
        or enter into contracts with, a school of dentistry, 
        public or nonprofit private hospital, or a public or 
        private nonprofit entity which the Secretary has 
        determined is capable of carrying out such grant or 
        contract--
                    (A) to plan, develop, and operate, or 
                participate in, an approved professional 
                training program in the field of general 
                dentistry, pediatric dentistry, or public 
                health dentistry for dental students, 
                residents, practicing dentists, dental 
                hygienists, or other approved primary care 
                dental trainees, that emphasizes training for 
                general, pediatric, or public health dentistry;
                    (B) to provide financial assistance to 
                dental students, residents, practicing 
                dentists, and dental hygiene students who are 
                in need thereof, who are participants in any 
                such program, and who plan to work in the 
                practice of general, pediatric, public heath 
                dentistry, or dental hygiene;
                    (C) to plan, develop, and operate a program 
                for the training of oral health care providers 
                who plan to teach in general, pediatric, public 
                health dentistry, or dental hygiene;
                    (D) to provide financial assistance in the 
                form of traineeships and fellowships to 
                dentists who plan to teach or are teaching in 
                general, pediatric, or public health dentistry;
                    (E) to meet the costs of projects to 
                establish, maintain, or improve dental faculty 
                development programs in primary care (which may 
                be departments, divisions or other units);
                    (F) to meet the costs of projects to 
                establish, maintain, or improve predoctoral and 
                postdoctoral training in primary care programs;
                    (G) to create a loan repayment program for 
                faculty in dental programs; and
                    (H) to provide technical assistance to 
                pediatric training programs in developing and 
                implementing instruction regarding the oral 
                health status, dental care needs, and risk-
                based clinical disease management of all 
                pediatric populations with an emphasis on 
                underserved children.
            (2) Faculty loan repayment.--
                    (A) In general.--A grant or contract under 
                subsection (a)(1)(G) may be awarded to a 
                program of general, pediatric, or public health 
                dentistry described in such subsection to plan, 
                develop, and operate a loan repayment program 
                under which--
                            (i) individuals agree to serve 
                        full-time as faculty members; and
                            (ii) the program of general, 
                        pediatric or public health dentistry 
                        agrees to pay the principal and 
                        interest on the outstanding student 
                        loans of the individuals.
                    (B) Manner of payments.--With respect to 
                the payments described in subparagraph (A)(ii), 
                upon completion by an individual of each of the 
                first, second, third, fourth, and fifth years 
                of service, the program shall pay an amount 
                equal to 10, 15, 20, 25, and 30 percent, 
                respectively, of the individual's student loan 
                balance as calculated based on principal and 
                interest owed at the initiation of the 
                agreement.
    (b) Eligible Entity.--For purposes of this subsection, 
entities eligible for such grants or contracts in general, 
pediatric, or public health dentistry shall include entities 
that have programs in dental or dental hygiene schools, or 
approved residency or advanced education programs in the 
practice of general, pediatric, or public health dentistry. 
Eligible entities may partner with schools of public health to 
permit the education of dental students, residents, and dental 
hygiene students for a master's year in public health at a 
school of public health.
    (c) Priorities in Making Awards.--With respect to training 
provided for under this section, the Secretary shall give 
priority in awarding grants or contracts to the following:
            (1) Qualified applicants that propose collaborative 
        projects between departments of primary care medicine 
        and departments of general, pediatric, or public health 
        dentistry.
            (2) Qualified applicants that have a record of 
        training the greatest percentage of providers, or that 
        have demonstrated significant improvements in the 
        percentage of providers, who enter and remain in 
        general, pediatric, or public health dentistry.
            (3) Qualified applicants that have a record of 
        training individuals who are from a rural or 
        disadvantaged background, or from underrepresented 
        minorities.
            (4) Qualified applicants that establish formal 
        relationships with Federally qualified health centers, 
        rural health centers, or accredited teaching facilities 
        and that conduct training of students, residents, 
        fellows, or faculty at the center or facility.
            (5) Qualified applicants that conduct teaching 
        programs targeting vulnerable populations such as older 
        adults, homeless individuals, victims of abuse or 
        trauma, individuals with mental health or substance-
        related disorders, individuals with disabilities, and 
        individuals with HIV/AIDS, and in the risk-based 
        clinical disease management of all populations.
            (6) Qualified applicants that include educational 
        activities in cultural competency and health literacy.
            (7) Qualified applicants that have a high rate for 
        placing graduates in practice settings that serve 
        underserved areas or health disparity populations, or 
        who achieve a significant increase in the rate of 
        placing graduates in such settings.
            (8) Qualified applicants that intend to establish a 
        special populations oral health care education center 
        or training program for the didactic and clinical 
        education of dentists, dental health professionals, and 
        dental hygienists who plan to teach oral health care 
        for people with developmental disabilities, cognitive 
        impairment, complex medical problems, significant 
        physical limitations, and vulnerable elderly.
    (d) Application.--An eligible entity desiring a grant under 
this section shall submit to the Secretary an application at 
such time, in such manner, and containing such information as 
the Secretary may require.
    (e) Duration of Award.--The period during which payments 
are made to an entity from an award of a grant or contract 
under subsection (a) shall be 5 years. The provision of such 
payments shall be subject to annual approval by the Secretary 
and subject to the availability of appropriations for the 
fiscal year involved to make the payments.
    (f) Authorizations of Appropriations.--For the purpose of 
carrying out subsections (a) and (b), there is authorized to be 
appropriated $30,000,000 for fiscal year 2010 and such sums as 
may be necessary for each of fiscal years 2011 through 2015.
    (g) Carryover Funds.--An entity that receives an award 
under this section may carry over funds from 1 fiscal year to 
another without obtaining approval from the Secretary. In no 
case may any funds be carried over pursuant to the preceding 
sentence for more than 3 years.

SEC. 749. [293L] ADVISORY COMMITTEE ON TRAINING IN PRIMARY CARE 
                    MEDICINE AND DENTISTRY.

    (a) Establishment.--The Secretary shall establish an 
advisory committee to be known as the Advisory Committee on 
Training in Primary Care Medicine and Dentistry (in this 
section referred to as the ``Advisory Committee'').
    (b) Composition.--
            (1) In general.--The Secretary shall determine the 
        appropriate number of individuals to serve on the 
        Advisory Committee. Such individuals shall not be 
        officers or employees of the Federal Government.
            (2) Appointment.--Not later than 90 days after the 
        date of enactment of this Act \1\, the Secretary shall 
        appoint the members of the Advisory Committee from 
        among individuals who are health professionals. In 
        making such appointments, the Secretary shall ensure a 
        fair balance between the health professions, that at 
        least 75 percent of the members of the Advisory 
        Committee are health professionals, a broad geographic 
        representation of members and a balance between urban 
        and rural members. Members shall be appointed based on 
        their competence, interest, and knowledge of the 
        mission of the profession involved.
---------------------------------------------------------------------------
    \1\ So in law. The reference to ``this Act'' means the Public 
Health Service Act, which was enacted July 1, 1944. Probably should be 
a reference to the Health Professions Education Partnerships Act of 
1998, which added section 748. That Act is Public Law 105-392, enacted 
November 13, 1998. (Section 102(4) of that Public Law (112 Stat. 3539) 
added section 748.)
---------------------------------------------------------------------------
            (3) Minority representation.--In appointing the 
        members of the Advisory Committee under paragraph (2), 
        the Secretary shall ensure the adequate representation 
        of women and minorities.
    (c) Terms.--
            (1) In general.--A member of the Advisory Committee 
        shall be appointed for a term of 3 years, except that 
        of the members first appointed--
                    (A) \1/3\ of such members shall serve for a 
                term of 1 year;
                    (B) \1/3\ of such members shall serve for a 
                term of 2 years; and
                    (C) \1/3\ of such members shall serve for a 
                term of 3 years.
            (2) Vacancies.--
                    (A) In general.--A vacancy on the Advisory 
                Committee shall be filled in the manner in 
                which the original appointment was made and 
                shall be subject to any conditions which 
                applied with respect to the original 
                appointment.
                    (B) Filling unexpired term.--An individual 
                chosen to fill a vacancy shall be appointed for 
                the unexpired term of the member replaced.
    (d) Duties.--The Advisory Committee shall--
            (1) provide advice and recommendations to the 
        Secretary concerning policy and program development and 
        other matters of significance concerning the activities 
        under section 747;
            (2) not later than 3 years after the date of 
        enactment of this section, and annually thereafter, 
        prepare and submit to the Secretary, and the Committee 
        on Labor and Human Resources of the Senate, and the 
        Committee on Commerce of the House of Representatives, 
        a report describing the activities of the Committee, 
        including findings and recommendations made by the 
        Committee concerning the activities under section 747;
            (3) develop, publish, and implement performance 
        measures for programs under this part;
            (4) develop and publish guidelines for longitudinal 
        evaluations (as described in section 761(d)(2)) for 
        programs under this part; and
            (5) recommend appropriation levels for programs 
        under this part.
    (e) Meetings and Documents.--
            (1) Meetings.--The Advisory Committee shall meet 
        not less than 2 times each year. Such meetings shall be 
        held jointly with other related entities established 
        under this title where appropriate.
            (2) Documents.--Not later than 14 days prior to the 
        convening of a meeting under paragraph (1), the 
        Advisory Committee shall prepare and make available an 
        agenda of the matters to be considered by the Advisory 
        Committee at such meeting. At any such meeting, the 
        Advisory Council \1\ shall distribute materials with 
        respect to the issues to be addressed at the meeting. 
        Not later than 30 days after the adjourning of such a 
        meeting, the Advisory Committee shall prepare and make 
        available a summary of the meeting and any actions 
        taken by the Committee based upon the meeting.
---------------------------------------------------------------------------
    \1\ So in law. Probably should be ``Advisory Committee''. See 
section 102(4) of Public Law 105-392 (112 Stat. 3539).
---------------------------------------------------------------------------
    (f) Compensation and Expenses.--
            (1) Compensation.--Each member of the Advisory 
        Committee shall be compensated at a rate equal to the 
        daily equivalent of the annual rate of basic pay 
        prescribed for level IV of the Executive Schedule under 
        section 5315 of title 5, United States Code, for each 
        day (including travel time) during which such member is 
        engaged in the performance of the duties of the 
        Committee.
            (2) Expenses.--The members of the Advisory 
        Committee shall be allowed travel expenses, including 
        per diem in lieu of subsistence, at rates authorized 
        for employees of agencies under subchapter I of chapter 
        57 of title 5, United States Code, while away from 
        their homes or regular places of business in the 
        performance of services for the Committee.
    (g) FACA.--The Federal Advisory Committee Act shall apply 
to the Advisory Committee under this section only to the extent 
that the provisions of such Act do not conflict with the 
requirements of this section.

SEC. 749A. [293L-1] TEACHING HEALTH CENTERS DEVELOPMENT GRANTS.

    (a) Program Authorized.--The Secretary may award grants 
under this section to teaching health centers for the purpose 
of establishing new accredited or expanded primary care 
residency programs.
    (b) Amount and Duration.--Grants awarded under this section 
shall be for a term of not more than 3 years and the maximum 
award may not be more than $500,000.
    (c) Use of Funds.--Amounts provided under a grant under 
this section shall be used to cover the costs of--
            (1) establishing or expanding a primary care 
        residency training program described in subsection (a), 
        including costs associated with--
                    (A) curriculum development;
                    (B) recruitment, training and retention of 
                residents and faculty:
                    (C) accreditation by the Accreditation 
                Council for Graduate Medical Education (ACGME), 
                the American Dental Association (ADA), or the 
                American Osteopathic Association (AOA); and
                    (D) faculty salaries during the development 
                phase; and
            (2) technical assistance provided by an eligible 
        entity.
    (d) Application.--A teaching health center seeking a grant 
under this section shall submit an application to the Secretary 
at such time, in such manner, and containing such information 
as the Secretary may require.
    (e) Preference for Certain Applications.--In selecting 
recipients for grants under this section, the Secretary shall 
give preference to any such application that documents an 
existing affiliation agreement with an area health education 
center program as defined in sections 751 and 799B.
    (f) Definitions.--In this section:
            (1) Eligible entity.--The term ``eligible entity'' 
        means an organization capable of providing technical 
        assistance including an area health education center 
        program as defined in sections 751 and 799B.
            (2) Primary care residency program.--The term 
        ``primary care residency program'' means an approved 
        graduate medical residency training program (as defined 
        in section 340H) in family medicine, internal medicine, 
        pediatrics, internal medicine-pediatrics, obstetrics 
        and gynecology, psychiatry, general dentistry, 
        pediatric dentistry, and geriatrics.
            (3) Teaching health center.--
                    (A) In general.--The term ``teaching health 
                center'' means an entity that--
                            (i) is a community based, 
                        ambulatory patient care center; and
                            (ii) operates a primary care 
                        residency program.
                    (B) Inclusion of certain entities.--Such 
                term includes the following:
                            (i) A Federally qualified health 
                        center (as defined in section 
                        1905(l)(2)(B), of the Social Security 
                        Act).
                            (ii) A community mental health 
                        center (as defined in section 
                        1861(ff)(3)(B) of the Social Security 
                        Act).
                            (iii) A rural health clinic, as 
                        defined in section 1861(aa) of the 
                        Social Security Act.
                            (iv) A health center operated by 
                        the Indian Health Service, an Indian 
                        tribe or tribal organization, or an 
                        urban Indian organization (as defined 
                        in section 4 of the Indian Health Care 
                        Improvement Act).
                            (v) An entity receiving funds under 
                        title X of the Public Health Service 
                        Act.
    (g) Authorization of Appropriations.--There is authorized 
to be appropriated, $25,000,000 for fiscal year 2010, 
$50,000,000 for fiscal year 2011, $50,000,000 for fiscal year 
2012, and such sums as may be necessary for each fiscal year 
thereafter to carry out this section. Not to exceed $5,000,000 
annually may be used for technical assistance program grants.

            Subpart II--Training in Underserved Communities

SEC. 749B. [293M] RURAL PHYSICIAN TRAINING GRANTS.

    (a) In General.--The Secretary, acting through the 
Administrator of the Health Resources and Services 
Administration, shall establish a grant program for the 
purposes of assisting eligible entities in recruiting students 
most likely to practice medicine in underserved rural 
communities, providing rural-focused training and experience, 
and increasing the number of recent allopathic and osteopathic 
medical school graduates who practice in underserved rural 
communities.
    (b) Eligible Entities.--In order to be eligible to receive 
a grant under this section, an entity shall--
            (1) be a school of allopathic or osteopathic 
        medicine accredited by a nationally recognized 
        accrediting agency or association approved by the 
        Secretary for this purpose, or any combination or 
        consortium of such schools; and
            (2) submit an application to the Secretary that 
        includes a certification that such entity will use 
        amounts provided to the institution as described in 
        subsection (d)(1).
    (c) Priority.--In awarding grant funds under this section, 
the Secretary shall give priority to eligible entities that--
            (1) demonstrate a record of successfully training 
        students, as determined by the Secretary, who practice 
        medicine in underserved rural communities;
            (2) demonstrate that an existing academic program 
        of the eligible entity produces a high percentage, as 
        determined by the Secretary, of graduates from such 
        program who practice medicine in underserved rural 
        communities;
            (3) demonstrate rural community institutional 
        partnerships, through such mechanisms as matching or 
        contributory funding, documented in-kind services for 
        implementation, or existence of training partners with 
        interprofessional expertise in community health center 
        training locations or other similar facilities; or
            (4) submit, as part of the application of the 
        entity under subsection (b), a plan for the long-term 
        tracking of where the graduates of such entity practice 
        medicine.
    (d) Use of Funds.--
            (1) Establishment.--An eligible entity receiving a 
        grant under this section shall use the funds made 
        available under such grant to establish, improve, or 
        expand a rural-focused training program (referred to in 
        this section as the ``Program'') meeting the 
        requirements described in this subsection and to carry 
        out such program.
            (2) Structure of program.--An eligible entity 
        shall--
                    (A) enroll no fewer than 10 students per 
                class year into the Program; and
                    (B) develop criteria for admission to the 
                Program that gives priority to students--
                            (i) who have originated from or 
                        lived for a period of 2 or more years 
                        in an underserved rural community; and
                            (ii) who express a commitment to 
                        practice medicine in an underserved 
                        rural community.
            (3) Curricula.--The Program shall require students 
        to enroll in didactic coursework and clinical 
        experience particularly applicable to medical practice 
        in underserved rural communities, including--
                    (A) clinical rotations in underserved rural 
                communities, and in applicable specialties, or 
                other coursework or clinical experience deemed 
                appropriate by the Secretary; and
                    (B) in addition to core school curricula, 
                additional coursework or training experiences 
                focused on medical issues prevalent in 
                underserved rural communities.
            (4) Residency placement assistance.--Where 
        available, the Program shall assist all students of the 
        Program in obtaining clinical training experiences in 
        locations with postgraduate programs offering residency 
        training opportunities in underserved rural 
        communities, or in local residency training programs 
        that support and train physicians to practice in 
        underserved rural communities.
            (5) Program student cohort support.--The Program 
        shall provide and require all students of the Program 
        to participate in group activities designed to further 
        develop, maintain, and reinforce the original 
        commitment of such students to practice in an 
        underserved rural community.
    (e) Annual Reporting.--An eligible entity receiving a grant 
under this section shall submit an annual report to the 
Secretary on the success of the Program, based on criteria the 
Secretary determines appropriate, including the residency 
program selection of graduating students who participated in 
the Program.
    (f) Regulations.--Not later than 60 days after the date of 
enactment of this section, the Secretary shall by regulation 
define `underserved rural community' for purposes of this 
section.
    (g) Supplement Not Supplant.--Any eligible entity receiving 
funds under this section shall use such funds to supplement, 
not supplant, any other Federal, State, and local funds that 
would otherwise be expended by such entity to carry out the 
activities described in this section.
    (h) Maintenance of Effort.--With respect to activities for 
which funds awarded under this section are to be expended, the 
entity shall agree to maintain expenditures of non-Federal 
amounts for such activities at a level that is not less than 
the level of such expenditures maintained by the entity for the 
fiscal year preceding the fiscal year for which the entity 
receives a grant under this section.
    (i) Authorization of Appropriations.--There are authorized 
to be appropriated $4,000,000 for each of the fiscal years 2010 
through 2013.

          PART D--INTERDISCIPLINARY, COMMUNITY-BASED LINKAGES

SEC. 750. [294] GENERAL PROVISIONS.

    (a) Collaboration.--To be eligible to receive assistance 
under this part, an academic institution shall use such 
assistance in collaboration with 2 or more disciplines.
    (b) Activities.--An entity shall use assistance under this 
part to carry out innovative demonstration projects for 
strategic workforce supplementation activities as needed to 
meet national goals for interdisciplinary, community-based 
linkages. Such assistance may be used consistent with this 
part--
            (1) to develop and support training programs;
            (2) for faculty development;
            (3) for model demonstration programs;
            (4) for the provision of stipends for fellowship 
        trainees;
            (5) to provide technical assistance; and
            (6) for other activities that will produce outcomes 
        consistent with the purposes of this part.

SEC. 751. [294A] AREA HEALTH EDUCATION CENTERS.

    (a) Establishment of Awards.--The Secretary shall make the 
following 2 types of awards in accordance with this section:
            (1) Infrastructure development award.--The 
        Secretary shall make awards to eligible entities to 
        enable such entities to initiate health care workforce 
        educational programs or to continue to carry out 
        comparable programs that are operating at the time the 
        award is made by planning, developing, operating, and 
        evaluating an area health education center program.
            (2) Point of service maintenance and enhancement 
        award.--The Secretary shall make awards to eligible 
        entities to maintain and improve the effectiveness and 
        capabilities of an existing area health education 
        center program, and make other modifications to the 
        program that are appropriate due to changes in 
        demographics, needs of the populations served, or other 
        similar issues affecting the area health education 
        center program. For the purposes of this section, the 
        term ``Program'' refers to the area health education 
        center program.
    (b) Eligible Entities; Application.--
            (1) Eligible entities.--
                    (A) Infrastructure development.--For 
                purposes of subsection (a)(1), the term 
                ``eligible entity'' means a school of medicine 
                or osteopathic medicine, an incorporated 
                consortium of such schools, or the parent 
                institutions of such a school. With respect to 
                a State in which no area health education 
                center program is in operation, the Secretary 
                may award a grant or contract under subsection 
                (a)(1) to a school of nursing.
                    (B) Point of service maintenance and 
                enhancement.--For purposes of subsection 
                (a)(2), the term ``eligible entity'' means an 
                entity that has received funds under this 
                section, is operating an area health education 
                center program, including an area health 
                education center or centers, and has a center 
                or centers that are no longer eligible to 
                receive financial assistance under subsection 
                (a)(1).
            (2) Application.--An eligible entity desiring to 
        receive an award under this section shall submit to the 
        Secretary an application at such time, in such manner, 
        and containing such information as the Secretary may 
        require.
    (c) Use of Funds.--
            (1) Required activities.--An eligible entity shall 
        use amounts awarded under a grant under subsection 
        (a)(1) or (a)(2) to carry out the following activities:
                    (A) Develop and implement strategies, in 
                coordination with the applicable one-stop 
                delivery system under section 134(c) of the 
                Workforce Investment Act of 1998, to recruit 
                individuals from underrepresented minority 
                populations or from disadvantaged or rural 
                backgrounds into health professions, and 
                support such individuals in attaining such 
                careers.
                    (B) Develop and implement strategies to 
                foster and provide community-based training and 
                education to individuals seeking careers in 
                health professions within underserved areas for 
                the purpose of developing and maintaining a 
                diverse health care workforce that is prepared 
                to deliver high-quality care, with an emphasis 
                on primary care, in underserved areas or for 
                health disparity populations, in collaboration 
                with other Federal and State health care 
                workforce development programs, the State 
                workforce agency, and local workforce 
                investment boards, and in health care safety 
                net sites.
                    (C) Prepare individuals to more effectively 
                provide health services to underserved areas 
                and health disparity populations through field 
                placements or preceptorships in conjunction 
                with community-based organizations, accredited 
                primary care residency training programs, 
                Federally qualified health centers, rural 
                health clinics, public health departments, or 
                other appropriate facilities.
                    (D) Conduct and participate in 
                interdisciplinary training that involves 
                physicians, physician assistants, nurse 
                practitioners, nurse midwives, dentists, 
                psychologists, pharmacists, optometrists, 
                community health workers, public and allied 
                health professionals, or other health 
                professionals, as practicable.
                    (E) Deliver or facilitate continuing 
                education and information dissemination 
                programs for health care professionals, with an 
                emphasis on individuals providing care in 
                underserved areas and for health disparity 
                populations.
                    (F) Propose and implement effective program 
                and outcomes measurement and evaluation 
                strategies.
                    (G) Establish a youth public health program 
                to expose and recruit high school students into 
                health careers, with a focus on careers in 
                public health.
            (2) Innovative opportunities.--An eligible entity 
        may use amounts awarded under a grant under subsection 
        (a)(1) or subsection (a)(2) to carry out any of the 
        following activities:
                    (A) Develop and implement innovative 
                curricula in collaboration with community-based 
                accredited primary care residency training 
                programs, Federally qualified health centers, 
                rural health clinics, behavioral and mental 
                health facilities, public health departments, 
                or other appropriate facilities, with the goal 
                of increasing the number of primary care 
                physicians and other primary care providers 
                prepared to serve in underserved areas and 
                health disparity populations.
                    (B) Coordinate community-based 
                participatory research with academic health 
                centers, and facilitate rapid flow and 
                dissemination of evidence-based health care 
                information, research results, and best 
                practices to improve quality, efficiency, and 
                effectiveness of health care and health care 
                systems within community settings.
                    (C) Develop and implement other strategies 
                to address identified workforce needs and 
                increase and enhance the health care workforce 
                in the area served by the area health education 
                center program.
    (d) Requirements.--
            (1) Area health education center program.--In 
        carrying out this section, the Secretary shall ensure 
        the following:
                    (A) An entity that receives an award under 
                this section shall conduct at least 10 percent 
                of clinical education required for medical 
                students in community settings that are removed 
                from the primary teaching facility of the 
                contracting institution for grantees that 
                operate a school of medicine or osteopathic 
                medicine. In States in which an entity that 
                receives an award under this section is a 
                nursing school or its parent institution, the 
                Secretary shall alternatively ensure that--
                            (i) the nursing school conducts at 
                        least 10 percent of clinical education 
                        required for nursing students in 
                        community settings that are remote from 
                        the primary teaching facility of the 
                        school; and
                            (ii) the entity receiving the award 
                        maintains a written agreement with a 
                        school of medicine or osteopathic 
                        medicine to place students from that 
                        school in training sites in the area 
                        health education center program area.
                    (B) An entity receiving funds under 
                subsection (a)(2) does not distribute such 
                funding to a center that is eligible to receive 
                funding under subsection (a)(1).
            (2) Area health education center.--The Secretary 
        shall ensure that each area health education center 
        program includes at least 1 area health education 
        center, and that each such center--
                    (A) is a public or private organization 
                whose structure, governance, and operation is 
                independent from the awardee and the parent 
                institution of the awardee;
                    (B) is not a school of medicine or 
                osteopathic medicine, the parent institution of 
                such a school, or a branch campus or other 
                subunit of a school of medicine or osteopathic 
                medicine or its parent institution, or a 
                consortium of such entities;
                    (C) designates an underserved area or 
                population to be served by the center which is 
                in a location removed from the main location of 
                the teaching facilities of the schools 
                participating in the program with such center 
                and does not duplicate, in whole or in part, 
                the geographic area or population served by any 
                other center;
                    (D) fosters networking and collaboration 
                among communities and between academic health 
                centers and community-based centers;
                    (E) serves communities with a demonstrated 
                need of health professionals in partnership 
                with academic medical centers;
                    (F) addresses the health care workforce 
                needs of the communities served in coordination 
                with the public workforce investment system; 
                and
                    (G) has a community-based governing or 
                advisory board that reflects the diversity of 
                the communities involved.
    (e) Matching Funds.--With respect to the costs of operating 
a program through a grant under this section, to be eligible 
for financial assistance under this section, an entity shall 
make available (directly or through contributions from State, 
county or municipal governments, or the private sector) 
recurring non-Federal contributions in cash or in kind, toward 
such costs in an amount that is equal to not less than 50 
percent of such costs. At least 25 percent of the total 
required non-Federal contributions shall be in cash. An entity 
may apply to the Secretary for a waiver of not more than 75 
percent of the matching fund amount required by the entity for 
each of the first 3 years the entity is funded through a grant 
under subsection (a)(1).
    (f) Limitation.--Not less than 75 percent of the total 
amount provided to an area health education center program 
under subsection (a)(1) or (a)(2) shall be allocated to the 
area health education centers participating in the program 
under this section. To provide needed flexibility to newly 
funded area health education center programs, the Secretary may 
waive the requirement in the sentence for the first 2 years of 
a new area health education center program funded under 
subsection (a)(1).
    (g) Award.--An award to an entity under this section shall 
be not less than $250,000 annually per area health education 
center included in the program involved. If amounts 
appropriated to carry out this section are not sufficient to 
comply with the preceding sentence, the Secretary may reduce 
the per center amount provided for in such sentence as 
necessary, provided the distribution established in subsection 
(j)(2) is maintained.
    (h) Project Terms.--
            (1) In general.--Except as provided in paragraph 
        (2), the period during which payments may be made under 
        an award under subsection (a)(1) may not exceed--
                    (A) in the case of a program, 12 years; or
                    (B) in the case of a center within a 
                program, 6 years.
            (2) Exception.--The periods described in paragraph 
        (1) shall not apply to programs receiving point of 
        service maintenance and enhancement awards under 
        subsection (a)(2) to maintain existing centers and 
        activities.
    (i) Inapplicability of Provision.--Notwithstanding any 
other provision of this title, section 791(a) shall not apply 
to an area health education center funded under this section.
    (j) Authorization of Appropriations.--
            (1) In general.--There is authorized to be 
        appropriated to carry out this section $125,000,000 for 
        each of the fiscal years 2010 through 2014.
            (2) Requirements.--Of the amounts appropriated for 
        a fiscal year under paragraph (1)--
                    (A) not more than 35 percent shall be used 
                for awards under subsection (a)(1);
                    (B) not less than 60 percent shall be used 
                for awards under subsection (a)(2);
                    (C) not more than 1 percent shall be used 
                for grants and contracts to implement outcomes 
                evaluation for the area health education 
                centers; and
                    (D) not more than 4 percent shall be used 
                for grants and contracts to provide technical 
                assistance to entities receiving awards under 
                this section.
            (3) Carryover funds.--An entity that receives an 
        award under this section may carry over funds from 1 
        fiscal year to another without obtaining approval from 
        the Secretary. In no case may any funds be carried over 
        pursuant to the preceding sentence for more than 3 
        years.
    (k) Sense of Congress.--It is the sense of the Congress 
that every State have an area health education center program 
in effect under this section.

SEC. 752. [294B] CONTINUING EDUCATIONAL SUPPORT FOR HEALTH 
                    PROFESSIONALS SERVING IN UNDERSERVED COMMUNITIES.

    (a) In General.--The Secretary shall make grants to, and 
enter into contracts with, eligible entities to improve health 
care, increase retention, increase representation of minority 
faculty members, enhance the practice environment, and provide 
information dissemination and educational support to reduce 
professional isolation through the timely dissemination of 
research findings using relevant resources.
    (b) Eligible Entities.--For purposes of this section, the 
term ``eligible entity'' means an entity described in section 
799(b).
    (c) Application.--An eligible entity desiring to receive an 
award under this section shall submit to the Secretary an 
application at such time, in such manner, and containing such 
information as the Secretary may require.
    (d) Use of Funds.--An eligible entity shall use amounts 
awarded under a grant or contract under this section to provide 
innovative supportive activities to enhance education through 
distance learning, continuing educational activities, 
collaborative conferences, and electronic and telelearning 
activities, with priority for primary care.
    (e) Authorization.--There is authorized to be appropriated 
to carry out this section $5,000,000 for each of the fiscal 
years 2010 through 2014, and such sums as may be necessary for 
each subsequent fiscal year.

SEC. 753. [294C] EDUCATION AND TRAINING RELATING TO GERIATRICS.

    (a) Geriatric Education Centers.--
            (1) In general.--The Secretary shall award grants 
        or contracts under this section to entities described 
        in paragraphs \1\ (1), (3), or (4) of section 799B, and 
        section 801(2), for the establishment or operation of 
        geriatric education centers.
---------------------------------------------------------------------------
    \1\ So in law. Probably should read ``paragraph''.
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            (2) Requirements.--A geriatric education center is 
        a program that--
                    (A) improves the training of health 
                professionals in geriatrics, including 
                geriatric residencies, traineeships, or 
                fellowships;
                    (B) develops and disseminates curricula 
                relating to the treatment of the health 
                problems of elderly individuals;
                    (C) supports the training and retraining of 
                faculty to provide instruction in geriatrics;
                    (D) supports continuing education of health 
                professionals who provide geriatric care; and
                    (E) provides students with clinical 
                training in geriatrics in nursing homes, 
                chronic and acute disease hospitals, ambulatory 
                care centers, and senior centers.
    (b) Geriatric Training Regarding Physicians and Dentists.--
            (1) In general.--The Secretary may make grants to, 
        and enter into contracts with, schools of medicine, 
        schools of osteopathic medicine, teaching hospitals, 
        and graduate medical education programs, for the 
        purpose of providing support (including residencies, 
        traineeships, and fellowships) for geriatric training 
        projects to train physicians, dentists and behavioral 
        and mental health professionals who plan to teach 
        geriatric medicine, geriatric behavioral or mental 
        health, or geriatric dentistry.
            (2) Requirements.--Each project for which a grant 
        or contract is made under this subsection shall--
                    (A) be staffed by full-time teaching 
                physicians who have experience or training in 
                geriatric medicine or geriatric behavioral or 
                mental health;
                    (B) be staffed, or enter into an agreement 
                with an institution staffed by full-time or 
                part-time teaching dentists who have experience 
                or training in geriatric dentistry;
                    (C) be staffed, or enter into an agreement 
                with an institution staffed by full-time or 
                part-time teaching behavioral mental health 
                professionals who have experience or training 
                in geriatric behavioral or mental health;
                    (D) be based in a graduate medical 
                education program in internal medicine or 
                family medicine or in a department of 
                geriatrics or behavioral or mental health;
                    (E) provide training in geriatrics and 
                exposure to the physical and mental 
                disabilities of elderly individuals through a 
                variety of service rotations, such as geriatric 
                consultation services, acute care services, 
                dental services, geriatric behavioral or mental 
                health units, day and home care programs, 
                rehabilitation services, extended care 
                facilities, geriatric ambulatory care and 
                comprehensive evaluation units, and community 
                care programs for elderly mentally retarded 
                individuals; and
                    (F) provide training in geriatrics through 
                one or both of the training options described 
                in subparagraphs (A) and (B) of paragraph (3).
            (3) Training options.--The training options 
        referred to in subparagraph (F) of paragraph (2) shall 
        be as follows:
                    (A) A 1-year retraining program in 
                geriatrics for--
                            (i) physicians who are faculty 
                        members in departments of internal 
                        medicine, family medicine, gynecology, 
                        geriatrics, and behavioral or mental 
                        health at schools of medicine and 
                        osteopathic medicine;
                            (ii) dentists who are faculty 
                        members at schools of dentistry or at 
                        hospital departments of dentistry; and
                            (iii) behavioral or mental health 
                        professionals who are faculty members 
                        in departments of behavioral or mental 
                        health; and
                    (B) A 2-year internal medicine or family 
                medicine fellowship program providing emphasis 
                in geriatrics, which shall be designed to 
                provide training in clinical geriatrics and 
                geriatrics research for--
                            (i) physicians who have completed 
                        graduate medical education programs in 
                        internal medicine, family medicine, 
                        behavioral or mental health, neurology, 
                        gynecology, or rehabilitation medicine;
                            (ii) dentists who have demonstrated 
                        a commitment to an academic career and 
                        who have completed postdoctoral dental 
                        training, including postdoctoral dental 
                        education programs or who have relevant 
                        advanced training or experience; and
                            (iii) behavioral or mental health 
                        professionals who have completed 
                        graduate medical education programs in 
                        behavioral or mental health.
            (4) Definitions.--For purposes of this subsection:
                    (A) The term ``graduate medical education 
                program'' means a program sponsored by a school 
                of medicine, a school of osteopathic medicine, 
                a hospital, or a public or private institution 
                that--
                            (i) offers postgraduate medical 
                        training in the specialties and 
                        subspecialties of medicine; and
                            (ii) has been accredited by the 
                        Accreditation Council for Graduate 
                        Medical Education or the American 
                        Osteopathic Association through its 
                        Committee on Postdoctoral Training.
                    (B) The term ``post-doctoral dental 
                education program'' means a program sponsored 
                by a school of dentistry, a hospital, or a 
                public or private institution that--
                            (i) offers post-doctoral training 
                        in the specialties of dentistry, 
                        advanced education in general 
                        dentistry, or a dental general practice 
                        residency; and
                            (ii) has been accredited by the 
                        Commission on Dental Accreditation.
    (c) Geriatric Faculty Fellowships.--
            (1) Establishment of program.--The Secretary shall 
        establish a program to provide Geriatric Academic 
        Career Awards to eligible individuals to promote the 
        career development of such individuals as academic 
        geriatricians.
            (2) Eligible individuals.--To be eligible to 
        receive an Award under paragraph (1), an individual 
        shall--
                    (A) be board certified or board eligible in 
                internal medicine, family practice, psychiatry, 
                or licensed dentistry, or have completed any 
                required training in a discipline and employed 
                in an accredited health professions school that 
                is approved by the Secretary;
                    (B) have completed an approved fellowship 
                program in geriatrics or have completed 
                specialty training in geriatrics as required by 
                the discipline and any addition geriatrics 
                training as required by the Secretary; and
                    (C) have a junior (non-tenured) faculty 
                appointment at an accredited (as determined by 
                the Secretary) school of medicine, osteopathic 
                medicine, nursing, social work, psychology, 
                dentistry, pharmacy, or other allied health 
                disciplines in an accredited health professions 
                school that is approved by the Secretary.
            (3) Limitations.--No Award under paragraph (1) may 
        be made to an eligible individual unless the 
        individual--
                    (A) has submitted to the Secretary an 
                application, at such time, in such manner, and 
                containing such information as the Secretary 
                may require, and the Secretary has approved 
                such application;
                    (B) provides, in such form and manner as 
                the Secretary may require, assurances that the 
                individual will meet the service requirement 
                described in paragraph (6); and
                    (C) provides, in such form and manner as 
                the Secretary may require, assurances that the 
                individual has a full-time faculty appointment 
                in a health professions institution and 
                documented commitment from such institution to 
                spend 75 percent of the total time of such 
                individual on teaching and developing skills in 
                interdisciplinary education in geriatrics.
            (4) Maintenance of effort.--An eligible individual 
        that receives an Award under paragraph (1) shall 
        provide assurances to the Secretary that funds provided 
        to the eligible individual under this subsection will 
        be used only to supplement, not to supplant, the amount 
        of Federal, State, and local funds otherwise expended 
        by the eligible individual.
            (5) Amount and term.--
                    (A) Amount.--The amount of an Award under 
                this section for individuals who are physicians 
                shall equal $50,000 for fiscal year 1998, 
                adjusted for subsequent fiscal years to reflect 
                the increase in the Consumer Price Index. The 
                Secretary shall determine the amount of an 
                Award under this section for individuals who 
                are not physicians.
                    (B) Term.--The term of any Award made under 
                this subsection shall not exceed 5 years.
                    (C) Payment to institution.--The Secretary 
                shall make payments to institutions which 
                include schools of medicine, osteopathic 
                medicine, nursing, social work, psychology, 
                dentistry, and pharmacy, or other allied health 
                discipline in an accredited health professions 
                school that is approved by the Secretary.
            (6) Service requirement.--An individual who 
        receives an Award under this subsection shall provide 
        training in clinical geriatrics, including the training 
        of interdisciplinary teams of health care 
        professionals. The provision of such training shall 
        constitute at least 75 percent of the obligations of 
        such individual under the Award.
    (d) Geriatric Workforce Development.--
            (1) In general.--The Secretary shall award grants 
        or contracts under this subsection to entities that 
        operate a geriatric education center pursuant to 
        subsection (a)(1).
            (2) Application.--To be eligible for an award under 
        paragraph (1), an entity described in such paragraph 
        shall submit to the Secretary an application at such 
        time, in such manner, and containing such information 
        as the Secretary may require.
            (3) Use of funds.--Amounts awarded under a grant or 
        contract under paragraph (1) shall be used to--
                    (A) carry out the fellowship program 
                described in paragraph (4); and
                    (B) carry out 1 of the 2 activities 
                described in paragraph (5).
            (4) Fellowship program.--
                    (A) In general.--Pursuant to paragraph (3), 
                a geriatric education center that receives an 
                award under this subsection shall use such 
                funds to offer short-term intensive courses 
                (referred to in this subsection as a 
                ``fellowship'') that focus on geriatrics, 
                chronic care management, and long-term care 
                that provide supplemental training for faculty 
                members in medical schools and other health 
                professions schools with programs in 
                psychology, pharmacy, nursing, social work, 
                dentistry, public health, allied health, or 
                other health disciplines, as approved by the 
                Secretary. Such a fellowship shall be open to 
                current faculty, and appropriately credentialed 
                volunteer faculty and practitioners, who do not 
                have formal training in geriatrics, to upgrade 
                their knowledge and clinical skills for the 
                care of older adults and adults with functional 
                limitations and to enhance their 
                interdisciplinary teaching skills.
                    (B) Location.--A fellowship shall be 
                offered either at the geriatric education 
                center that is sponsoring the course, in 
                collaboration with other geriatric education 
                centers, or at medical schools, schools of 
                dentistry, schools of nursing, schools of 
                pharmacy, schools of social work, graduate 
                programs in psychology, or allied health and 
                other health professions schools approved by 
                the Secretary with which the geriatric 
                education centers are affiliated.
                    (C) CME credit.--Participation in a 
                fellowship under this paragraph shall be 
                accepted with respect to complying with 
                continuing health profession education 
                requirements. As a condition of such 
                acceptance, the recipient shall agree to 
                subsequently provide a minimum of 18 hours of 
                voluntary instructional support through a 
                geriatric education center that is providing 
                clinical training to students or trainees in 
                long-term care settings.
            (5) Additional required activities described.--
        Pursuant to paragraph (3), a geriatric education center 
        that receives an award under this subsection shall use 
        such funds to carry out 1 of the following 2 
        activities.
                    (A) Family caregiver and direct care 
                provider training.--A geriatric education 
                center that receives an award under this 
                subsection shall offer at least 2 courses each 
                year, at no charge or nominal cost, to family 
                caregivers and direct care providers that are 
                designed to provide practical training for 
                supporting frail elders and individuals with 
                disabilities. The Secretary shall require such 
                Centers to work with appropriate community 
                partners to develop training program content 
                and to publicize the availability of training 
                courses in their service areas. All family 
                caregiver and direct care provider training 
                programs shall include instruction on the 
                management of psychological and behavioral 
                aspects of dementia, communication techniques 
                for working with individuals who have dementia, 
                and the appropriate, safe, and effective use of 
                medications for older adults.
                    (B) Incorporation of best practices.--A 
                geriatric education center that receives an 
                award under this subsection shall develop and 
                include material on depression and other mental 
                disorders common among older adults, medication 
                safety issues for older adults, and management 
                of the psychological and behavioral aspects of 
                dementia and communication techniques with 
                individuals who have dementia in all training 
                courses, where appropriate.
            (6) Targets.--A geriatric education center that 
        receives an award under this subsection shall meet 
        targets approved by the Secretary for providing 
        geriatric training to a certain number of faculty or 
        practitioners during the term of the award, as well as 
        other parameters established by the Secretary.
            (7) Amount of award.--An award under this 
        subsection shall be in an amount of $150,000. Not more 
        than 24 geriatric education centers may receive an 
        award under this subsection.
            (8) Maintenance of effort.--A geriatric education 
        center that receives an award under this subsection 
        shall provide assurances to the Secretary that funds 
        provided to the geriatric education center under this 
        subsection will be used only to supplement, not to 
        supplant, the amount of Federal, State, and local funds 
        otherwise expended by the geriatric education center.
            (9) Authorization of appropriations.--In addition 
        to any other funding available to carry out this 
        section, there is authorized to be appropriated to 
        carry out this subsection, $10,800,000 for the period 
        of fiscal year 2011 through 2014.
    (e) Geriatric Career Incentive Awards.--
            (1) In general.--The Secretary shall award grants 
        or contracts under this section to individuals 
        described in paragraph (2) to foster greater interest 
        among a variety of health professionals in entering the 
        field of geriatrics, long-term care, and chronic care 
        management.
            (2) Eligible individuals.--To be eligible to 
        received an award under paragraph (1), an individual 
        shall--
                    (A) be an advanced practice nurse, a 
                clinical social worker, a pharmacist, or 
                student of psychology who is pursuing a 
                doctorate or other advanced degree in 
                geriatrics or related fields in an accredited 
                health professions school; and
                    (B) submit to the Secretary an application 
                at such time, in such manner, and containing 
                such information as the Secretary may require.
            (3) Condition of award.--As a condition of 
        receiving an award under this subsection, an individual 
        shall agree that, following completion of the award 
        period, the individual will teach or practice in the 
        field of geriatrics, long-term care, or chronic care 
        management for a minimum of 5 years under guidelines 
        set by the Secretary.
            (4) Authorization of appropriations.--There is 
        authorized to be appropriated to carry out this 
        subsection, $10,000,000 for the period of fiscal years 
        2011 through 2013.

SEC. 754. [294D] QUENTIN N. BURDICK PROGRAM FOR RURAL INTERDISCIPLINARY 
                    TRAINING.

    (a) Grants.--The Secretary may make grants or contracts 
under this section to help entities fund authorized activities 
under an application approved under subsection (c).
    (b) Use of Amounts.--
            (1) In general.--Amounts provided under subsection 
        (a) shall be used by the recipients to fund 
        interdisciplinary training projects designed to--
                    (A) use new and innovative methods to train 
                health care practitioners to provide services 
                in rural areas;
                    (B) demonstrate and evaluate innovative 
                interdisciplinary methods and models designed 
                to provide access to cost-effective 
                comprehensive health care;
                    (C) deliver health care services to 
                individuals residing in rural areas;
                    (D) enhance the amount of relevant research 
                conducted concerning health care issues in 
                rural areas; and
                    (E) increase the recruitment and retention 
                of health care practitioners from rural areas 
                and make rural practice a more attractive 
                career choice for health care practitioners.
            (2) Methods.--A recipient of funds under subsection 
        (a) may use various methods in carrying out the 
        projects described in paragraph (1), including--
                    (A) the distribution of stipends to 
                students of eligible applicants;
                    (B) the establishment of a post-doctoral 
                fellowship program;
                    (C) the training of faculty in the economic 
                and logistical problems confronting rural 
                health care delivery systems; or
                    (D) the purchase or rental of 
                transportation and telecommunication equipment 
                where the need for such equipment due to unique 
                characteristics of the rural area is 
                demonstrated by the recipient.
            (3) Administration.--
                    (A) In general.--An applicant shall not use 
                more than 10 percent of the funds made 
                available to such applicant under subsection 
                (a) for administrative expenses.
                    (B) Training.--Not more than 10 percent of 
                the individuals receiving training with funds 
                made available to an applicant under subsection 
                (a) shall be trained as doctors of medicine or 
                doctors of osteopathy.
                    (C) Limitation.--An institution that 
                receives a grant under this section shall use 
                amounts received under such grant to 
                supplement, not supplant, amounts made 
                available by such institution for activities of 
                the type described in subsection (b)(1) in the 
                fiscal year preceding the year for which the 
                grant is received.
    (c) Applications.--Applications submitted for assistance 
under this section shall--
            (1) be jointly submitted by at least two eligible 
        applicants with the express purpose of assisting 
        individuals in academic institutions in establishing 
        long-term collaborative relationships with health care 
        providers in rural areas; and
            (2) designate a rural health care agency or 
        agencies for clinical treatment or training, including 
        hospitals, community health centers, migrant health 
        centers, rural health clinics, community behavioral and 
        mental health centers, long-term care facilities, 
        Native Hawaiian health centers, or facilities operated 
        by the Indian Health Service or an Indian tribe or 
        tribal organization or Indian organization under a 
        contract with the Indian Health Service under the 
        Indian Self-Determination Act.
    (d) Definitions.--For the purposes of this section, the 
term ``rural'' means geographic areas that are located outside 
of standard metropolitan statistical areas.

SEC. 755. [294E] ALLIED HEALTH AND OTHER DISCIPLINES.

    (a) In General.--The Secretary may make grants or contracts 
under this section to help entities fund activities of the type 
described in subsection (b).
    (b) Activities.--Activities of the type described in this 
subsection include the following:
            (1) Assisting entities in meeting the costs 
        associated with expanding or establishing programs that 
        will increase the number of individuals trained in 
        allied health professions. Programs and activities 
        funded under this paragraph may include--
                    (A) those that expand enrollments in allied 
                health professions with the greatest shortages 
                or whose services are most needed by the 
                elderly;
                    (B) those that provide rapid transition 
                training programs in allied health fields to 
                individuals who have baccalaureate degrees in 
                health-related sciences;
                    (C) those that establish community-based 
                allied health training programs that link 
                academic centers to rural clinical settings;
                    (D) those that provide career advancement 
                training for practicing allied health 
                professionals;
                    (E) those that expand or establish clinical 
                training sites for allied health professionals 
                in medically underserved or rural communities 
                in order to increase the number of individuals 
                trained;
                    (F) those that develop curriculum that will 
                emphasize knowledge and practice in the areas 
                of prevention and health promotion, geriatrics, 
                long-term care, home health and hospice care, 
                and ethics;
                    (G) those that expand or establish 
                interdisciplinary training programs that 
                promote the effectiveness of allied health 
                practitioners in geriatric assessment and the 
                rehabilitation of the elderly;
                    (H) those that expand or establish 
                demonstration centers to emphasize innovative 
                models to link allied health clinical practice, 
                education, and research;
                    (I) those that provide financial assistance 
                (in the form of traineeships) to students who 
                are participants in any such program; and
                            (i) who plan to pursue a career in 
                        an allied health field that has a 
                        demonstrated personnel shortage; and
                            (ii) who agree upon completion of 
                        the training program to practice in a 
                        medically underserved community;
                that shall be utilized to assist in the payment 
                of all or part of the costs associated with 
                tuition, fees and such other stipends as the 
                Secretary may consider necessary; and
                    (J) those to meet the costs of projects to 
                plan, develop, and operate or maintain graduate 
                programs in behavioral and mental health 
                practice.
            (2) Planning and implementing projects in 
        preventive and primary care training for podiatric 
        physicians in approved or provisionally approved 
        residency programs that shall provide financial 
        assistance in the form of traineeships to residents who 
        participate in such projects and who plan to specialize 
        in primary care.
            (3) Carrying out demonstration projects in which 
        chiropractors and physicians collaborate to identify 
        and provide effective treatment for spinal and lower-
        back conditions.

SEC. 756. [294E-1] MENTAL AND BEHAVIORAL HEALTH EDUCATION AND TRAINING 
                    GRANTS.

    (a) Grants Authorized.--The Secretary may award grants to 
eligible institutions of higher education to support the 
recruitment of students for, and education and clinical 
experience of the students in--
            (1) baccalaureate, master's, and doctoral degree 
        programs of social work, as well as the development of 
        faculty in social work;
            (2) accredited master's, doctoral, internship, and 
        post-doctoral residency programs of psychology for the 
        development and implementation of interdisciplinary 
        training of psychology graduate students for providing 
        behavioral and mental health services, including 
        substance abuse prevention and treatment services;
            (3) accredited institutions of higher education or 
        accredited professional training programs that are 
        establishing or expanding internships or other field 
        placement programs in child and adolescent mental 
        health in psychiatry, psychology, school psychology, 
        behavioral pediatrics, psychiatric nursing, social 
        work, school social work, substance abuse prevention 
        and treatment, marriage and family therapy, school 
        counseling, or professional counseling; and
            (4) State-licensed mental health nonprofit and for-
        profit organizations to enable such organizations to 
        pay for programs for preservice or in-service training 
        of paraprofessional child and adolescent mental health 
        workers.
    (b) Eligibility Requirements.--To be eligible for a grant 
under this section, an institution shall demonstrate--
            (1) participation in the institutions' programs of 
        individuals and groups from different racial, ethnic, 
        cultural, geographic, religious, linguistic, and class 
        backgrounds, and different genders and sexual 
        orientations;
            (2) knowledge and understanding of the concerns of 
        the individuals and groups described in subsection (a);
            (3) any internship or other field placement program 
        assisted under the grant will prioritize cultural and 
        linguistic competency;
            (4) the institution will provide to the Secretary 
        such data, assurances, and information as the Secretary 
        may require; and
            (5) with respect to any violation of the agreement 
        between the Secretary and the institution, the 
        institution will pay such liquidated damages as 
        prescribed by the Secretary by regulation.
    (c) Institutional Requirement.--For grants authorized under 
subsection (a)(1), at least 4 of the grant recipients shall be 
historically black colleges or universities or other minority-
serving institutions.
    (d) Priority.--
            (1) In selecting the grant recipients in social 
        work under subsection (a)(1), the Secretary shall give 
        priority to applicants that--
                    (A) are accredited by the Council on Social 
                Work Education;
                    (B) have a graduation rate of not less than 
                80 percent for social work students; and
                    (C) exhibit an ability to recruit social 
                workers from and place social workers in areas 
                with a high need and high demand population.
            (2) In selecting the grant recipients in graduate 
        psychology under subsection (a)(2), the Secretary shall 
        give priority to institutions in which training focuses 
        on the needs of vulnerable groups such as older adults 
        and children, individuals with mental health or 
        substance-related disorders, victims of abuse or trauma 
        and of combat stress disorders such as posttraumatic 
        stress disorder and traumatic brain injuries, homeless 
        individuals, chronically ill persons, and their 
        families.
            (3) In selecting the grant recipients in training 
        programs in child and adolescent mental health under 
        subsections (a)(3) and (a)(4), the Secretary shall give 
        priority to applicants that--
                    (A) have demonstrated the ability to 
                collect data on the number of students trained 
                in child and adolescent mental health and the 
                populations served by such students after 
                graduation or completion of preservice or in-
                service training;
                    (B) have demonstrated familiarity with 
                evidence-based methods in child and adolescent 
                mental health services, including substance 
                abuse prevention and treatment services;
                    (C) have programs designed to increase the 
                number of professionals and paraprofessionals 
                serving high-priority populations and to 
                applicants who come from high-priority 
                communities and plan to serve medically 
                underserved populations, in health professional 
                shortage areas, or in medically underserved 
                areas;
                    (D) offer curriculum taught collaboratively 
                with a family on the consumer and family lived 
                experience or the importance of family-
                professional or family-paraprofessional 
                partnerships; and
                    (E) provide services through a community 
                mental health program described in section 
                1913(b)(1).
    (e) Authorization of Appropriation.--For the fiscal years 
2010 through 2013, there is authorized to be appropriated to 
carry out this section--
            (1) $8,000,000 for training in social work in 
        subsection (a)(1);
            (2) $12,000,000 for training in graduate psychology 
        in subsection (a)(2), of which not less than 
        $10,000,000 shall be allocated for doctoral, 
        postdoctoral, and internship level training;
            (3) $10,000,000 for training in professional child 
        and adolescent mental health in subsection (a)(3); and
            (4) $5,000,000 for training in paraprofessional 
        child and adolescent work in subsection (a)(4).

SEC. 757. [294F] ADVISORY COMMITTEE ON INTERDISCIPLINARY, COMMUNITY-
                    BASED LINKAGES.

    (a) Establishment.--The Secretary shall establish an 
advisory committee to be known as the Advisory Committee on 
Interdisciplinary, Community-Based Linkages (in this section 
referred to as the ``Advisory Committee'').
    (b) Composition.--
            (1) In general.--The Secretary shall determine the 
        appropriate number of individuals to serve on the 
        Advisory Committee. Such individuals shall not be 
        officers or employees of the Federal Government.
            (2) Appointment.--Not later than 90 days after the 
        date of enactment of this Act \1\, the Secretary shall 
        appoint the members of the Advisory Committee from 
        among individuals who are health professionals from 
        schools of the types described in sections 
        751(b)(1)(A), 753(b), and 755(b). In making such 
        appointments, the Secretary shall ensure a fair balance 
        between the health professions, that at least 75 
        percent of the members of the Advisory Committee are 
        health professionals, a broad geographic representation 
        of members and a balance between urban and rural 
        members. Members shall be appointed based on their 
        competence, interest, and knowledge of the mission of 
        the profession involved.
---------------------------------------------------------------------------
    \1\ So in law. The reference to ``this Act'' means the Public 
Health Service Act, which was enacted July 1, 1944. Probably should be 
a reference to the Health Professions Education Partnerships Act of 
1998, which added section 756. That Act is Public Law 105-392, enacted 
November 13, 1998. (Section 103 of that Public Law (112 Stat. 3541) 
added section 756.)
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            (3) Minority representation.--In appointing the 
        members of the Advisory Committee under paragraph (2), 
        the Secretary shall ensure the adequate representation 
        of women and minorities.
    (c) Terms.--
            (1) In general.--A member of the Advisory Committee 
        shall be appointed for a term of 3 years, except that 
        of the members first appointed--
                    (A) \1/3\ of the members shall serve for a 
                term of 1 year;
                    (B) \1/3\ of the members shall serve for a 
                term of 2 years; and
                    (C) \1/3\ of the members shall serve for a 
                term of 3 years.
            (2) Vacancies.--
                    (A) In general.--A vacancy on the Advisory 
                Committee shall be filled in the manner in 
                which the original appointment was made and 
                shall be subject to any conditions which 
                applied with respect to the original 
                appointment.
                    (B) Filling unexpired term.--An individual 
                chosen to fill a vacancy shall be appointed for 
                the unexpired term of the member replaced.
    (d) Duties.--The Advisory Committee shall--
            (1) provide advice and recommendations to the 
        Secretary concerning policy and program development and 
        other matters of significance concerning the activities 
        under this part;
            (2) not later than 3 years after the date of 
        enactment of this section, and annually thereafter, 
        prepare and submit to the Secretary, and the Committee 
        on Labor and Human Resources of the Senate, and the 
        Committee on Commerce of the House of Representatives, 
        a report describing the activities of the Committee, 
        including findings and recommendations made by the 
        Committee concerning the activities under this part;
            (3) develop, publish, and implement performance 
        measures for programs under this part;
            (4) develop and publish guidelines for longitudinal 
        evaluations (as described in section 761(d)(2)) for 
        programs under this part; and
            (5) recommend appropriation levels for programs 
        under this part.
    (e) Meetings and Documents.--
            (1) Meetings.--The Advisory Committee shall meet 
        not less than 3 times each year. Such meetings shall be 
        held jointly with other related entities established 
        under this title where appropriate.
            (2) Documents.--Not later than 14 days prior to the 
        convening of a meeting under paragraph (1), the 
        Advisory Committee shall prepare and make available an 
        agenda of the matters to be considered by the Advisory 
        Committee at such meeting. At any such meeting, the 
        Advisory Council \1\ shall distribute materials with 
        respect to the issues to be addressed at the meeting. 
        Not later than 30 days after the adjourning of such a 
        meeting, the Advisory Committee shall prepare and make 
        available a summary of the meeting and any actions 
        taken by the Committee based upon the meeting.
---------------------------------------------------------------------------
    \1\ So in law. Probably should be ``Advisory Committee''. See 
section 103 of Public Law 105-392 (112 Stat. 3541).
---------------------------------------------------------------------------
    (f) Compensation and Expenses.--
            (1) Compensation.--Each member of the Advisory 
        Committee shall be compensated at a rate equal to the 
        daily equivalent of the annual rate of basic pay 
        prescribed for level IV of the Executive Schedule under 
        section 5315 of title 5, United States Code, for each 
        day (including travel time) during which such member is 
        engaged in the performance of the duties of the 
        Committee.
            (2) Expenses.--The members of the Advisory 
        Committee shall be allowed travel expenses, including 
        per diem in lieu of subsistence, at rates authorized 
        for employees of agencies under subchapter I of chapter 
        57 of title 5, United States Code, while away from 
        their homes or regular places of business in the 
        performance of services for the Committee.
    (g) FACA.--The Federal Advisory Committee Act shall apply 
to the Advisory Committee under this section only to the extent 
that the provisions of such Act do not conflict with the 
requirements of this section.

SEC. 758. [294H] INTERDISCIPLINARY TRAINING AND EDUCATION ON DOMESTIC 
                    VIOLENCE AND OTHER TYPES OF VIOLENCE AND ABUSE.

    (a) Grants.--The Secretary, acting through the Director of 
the Health Resources and Services Administration, shall award 
grants under this section to develop interdisciplinary training 
and education programs that provide undergraduate, graduate, 
post-graduate medical, nursing (including advanced practice 
nursing students), and other health professions students with 
an understanding of, and clinical skills pertinent to, domestic 
violence, sexual assault, stalking, and dating violence.
    (b) Eligibility.--To be eligible to receive a grant under 
this section an entity shall--
            (1) be an accredited school of allopathic or 
        osteopathic medicine;
            (2) prepare and submit to the Secretary an 
        application at such time, in such manner, and 
        containing such information as the Secretary may 
        require, including--
                    (A) information to demonstrate that the 
                applicant includes the meaningful participation 
                of a school of nursing and at least one other 
                school of health professions or graduate 
                program in public health, dentistry, social 
                work, midwifery, or behavioral and mental 
                health;
                    (B) strategies for the dissemination and 
                sharing of curricula and other educational 
                materials developed under the grant to other 
                interested medical and nursing schools and 
                national resource repositories for materials on 
                domestic violence and sexual assault; and
                    (C) a plan for consulting with community-
                based coalitions or individuals who have 
                experience and expertise in issues related to 
                domestic violence, sexual assault, dating 
                violence, and stalking for services provided 
                under the program carried out under the grant.
    (c) Use of Funds.--
            (1) Required uses.--Amounts provided under a grant 
        under this section shall be used to--
                    (A) fund interdisciplinary training and 
                education projects that are designed to train 
                medical, nursing, and other health professions 
                students and residents to identify and provide 
                health care services (including mental or 
                behavioral health care services and referrals 
                to appropriate community services) to 
                individuals who are experiencing \1\ or who 
                have experienced domestic violence, sexual 
                assault, and stalking or dating violence; and
---------------------------------------------------------------------------
    \1\ Section 4(c) of Public Law 109-271 amended section 758(c)(1)(A) 
of the Public Health Service[s] Act. The reference to the amended law 
should have been made to the Public Health Service Act but was executed 
to reflect the probable intent of Congress.
---------------------------------------------------------------------------
                    (B) plan and develop culturally competent 
                clinical components for integration into 
                approved residency training programs that 
                address health issues related to domestic 
                violence, sexual assault, dating violence, and 
                stalking, along with other forms of violence as 
                appropriate, and include the primacy of victim 
                safety and confidentiality.
            (2) Permissive uses.--Amounts provided under a 
        grant under this section may be used to--
                    (A) offer community-based training 
                opportunities in rural areas for medical, 
                nursing, and other students and residents on 
                domestic violence, sexual assault, stalking, 
                and dating violence, and other forms of 
                violence and abuse, which may include the use 
                of distance learning networks and other 
                available technologies needed to reach isolated 
                rural areas; or
                    (B) provide stipends to students who are 
                underrepresented in the health professions as 
                necessary to promote and enable their 
                participation in clerkships, preceptorships, or 
                other offsite training experiences that are 
                designed to develop health care clinical skills 
                related to domestic violence, sexual assault, 
                dating violence, and stalking.
            (3) Requirements.--
                    (A) Confidentiality and safety.--Grantees 
                under this section shall ensure that all 
                educational programs developed with grant funds 
                address issues of confidentiality and patient 
                safety, and that faculty and staff associated 
                with delivering educational components are 
                fully trained in procedures that will protect 
                the immediate and ongoing security of the 
                patients, patient records, and staff. Advocacy-
                based coalitions or other expertise available 
                in the community shall be consulted on the 
                development and adequacy of confidentially and 
                security procedures, and shall be fairly 
                compensated by grantees for their services.
                    (B) Rural programs.--Rural training 
                programs carried out under paragraph (2)(A) 
                shall reflect adjustments in protocols and 
                procedures or referrals that may be needed to 
                protect the confidentiality and safety of 
                patients who live in small or isolated 
                communities and who are currently or have 
                previously experienced violence or abuse.
            (4) Child and elder abuse.--Issues related to child 
        and elder abuse may be addressed as part of a 
        comprehensive programmatic approach implemented under a 
        grant under this section.
    (d) Requirements of Grantees.--
            (1) Limitation on administrative expenses.--A 
        grantee shall not use more than 10 percent of the 
        amounts received under a grant under this section for 
        administrative expenses.
            (2) Contribution of funds.--A grantee under this 
        section, and any entity receiving assistance under the 
        grant for training and education, shall contribute non-
        Federal funds, either directly or through in-kind 
        contributions, to the costs of the activities to be 
        funded under the grant in an amount that is not less 
        than 25 percent of the total cost of such activities.
    (e) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section, $3,000,000 for 
each of fiscal years 2007 through 2011. Amounts appropriated 
under this subsection shall remain available until expended.

SEC. 759. [294I] PROGRAM FOR EDUCATION AND TRAINING IN PAIN CARE.

    (a) In General.--The Secretary may make awards of grants, 
cooperative agreements, and contracts to health professions 
schools, hospices, and other public and private entities for 
the development and implementation of programs to provide 
education and training to health care professionals in pain 
care.
    (b) Certain Topics.--An award may be made under subsection 
(a) only if the applicant for the award agrees that the program 
carried out with the award will include information and 
education on--
            (1) recognized means for assessing, diagnosing, 
        treating, and managing pain and related signs and 
        symptoms, including the medically appropriate use of 
        controlled substances;
            (2) applicable laws, regulations, rules, and 
        policies on controlled substances, including the degree 
        to which misconceptions and concerns regarding such 
        laws, regulations, rules, and policies, or the 
        enforcement thereof, may create barriers to patient 
        access to appropriate and effective pain care;
            (3) interdisciplinary approaches to the delivery of 
        pain care, including delivery through specialized 
        centers providing comprehensive pain care treatment 
        expertise;
            (4) cultural, linguistic, literacy, geographic, and 
        other barriers to care in underserved populations; and
            (5) recent findings, developments, and improvements 
        in the provision of pain care.
    (c) Evaluation of Programs.--The Secretary shall (directly 
or through grants or contracts) provide for the evaluation of 
programs implemented under subsection (a) in order to determine 
the effect of such programs on knowledge and practice of pain 
care.
    (d) Pain Care Defined.--For purposes of this section the 
term ``pain care'' means the assessment, diagnosis, treatment, 
or management of acute or chronic pain regardless of causation 
or body location.
    (e) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section, such sums as may 
be necessary for each of the fiscal years 2010 through 2012. 
Amounts appropriated under this subsection shall remain 
available until expended.

         PART E--HEALTH PROFESSIONS AND PUBLIC HEALTH WORKFORCE

    Subpart 1--Health Professions Workforce Information and Analysis

SEC. 761. [294N] HEALTH PROFESSIONS WORKFORCE INFORMATION AND ANALYSIS.

    (a) Purpose.--It is the purpose of this section to--
            (1) provide for the development of information 
        describing the health professions workforce and the 
        analysis of workforce related issues; and
            (2) provide necessary information for decision-
        making regarding future directions in health 
        professions and nursing programs in response to 
        societal and professional needs.
    (b) National Center for Health Care Workforce Analysis.--
            (1) Establishment.--The Secretary shall establish 
        the National Center for Health Workforce Analysis 
        (referred to in this section as the ``National 
        Center'').
            (2) Purposes.--The National Center, in coordination 
        to the extent practicable with the National Health Care 
        Workforce Commission (established in section 5101 of 
        the Patient Protection and Affordable Care Act), and 
        relevant regional and State centers and agencies, 
        shall--
                    (A) provide for the development of 
                information describing and analyzing the health 
                care workforce and workforce related issues;
                    (B) carry out the activities under section 
                792(a);
                    (C) annually evaluate programs under this 
                title;
                    (D) develop and publish performance 
                measures and benchmarks for programs under this 
                title; and
                    (E) establish, maintain, and publicize a 
                national Internet registry of each grant 
                awarded under this title and a database to 
                collect data from longitudinal evaluations (as 
                described in subsection (d)(2)) on performance 
                measures (as developed under sections 
                749(d)(3), 757(d)(3), and 762(a)(3)).
            (3) Collaboration and data sharing.--
                    (A) In general.--The National Center shall 
                collaborate with Federal agencies and relevant 
                professional and educational organizations or 
                societies for the purpose of linking data 
                regarding grants awarded under this title.
                    (B) Contracts for health workforce 
                analysis.--For the purpose of carrying out the 
                activities described in subparagraph (A), the 
                National Center may enter into contracts with 
                relevant professional and educational 
                organizations or societies.
    (c) State and Regional Centers for Health Workforce 
Analysis.--
            (1) In general.--The Secretary shall award grants 
        to, or enter into contracts with, eligible entities for 
        purposes of--
                    (A) collecting, analyzing, and reporting 
                data regarding programs under this title to the 
                National Center and to the public; and
                    (B) providing technical assistance to local 
                and regional entities on the collection, 
                analysis, and reporting of data.
            (2) Eligible entities.--To be eligible for a grant 
        or contract under this subsection, an entity shall--
                    (A) be a State, a State workforce 
                investment board, a public health or health 
                professions school, an academic health center, 
                or an appropriate public or private nonprofit 
                entity; and
                    (B) submit to the Secretary an application 
                at such time, in such manner, and containing 
                such information as the Secretary may require.
    (d) Increase in Grants for Longitudinal Evaluations.--
            (1) In general.--The Secretary shall increase the 
        amount awarded to an eligible entity under this title 
        for a longitudinal evaluation of individuals who have 
        received education, training, or financial assistance 
        from programs under this title.
            (2) Capability.--A longitudinal evaluation shall be 
        capable of--
                    (A) studying practice patterns; and
                    (B) collecting and reporting data on 
                performance measures developed under sections 
                749(d)(3), 757(d)(3), and 762(a)(3).
            (3) Guidelines.--A longitudinal evaluation shall 
        comply with guidelines issued under sections 749(d)(4), 
        757(d)(4), and 762(a)(4).
            (4) Eligible entities.--To be eligible to obtain an 
        increase under this section, an entity shall be a 
        recipient of a grant or contract under this title.
    (e) Authorization of Appropriations.--
            (1) In general.--
                    (A) National center.--To carry out 
                subsection (b), there are authorized to be 
                appropriated $7,500,000 for each of fiscal 
                years 2010 through 2014.
                    (B) State and regional centers.--To carry 
                out subsection (c), there are authorized to be 
                appropriated $4,500,000 for each of fiscal 
                years 2010 through 2014.
                    (C) Grants for longitudinal evaluations.--
                To carry out subsection (d), there are 
                authorized to be appropriated such sums as may 
                be necessary for fiscal years 2010 through 
                2014.
            (2) Reservation.--Of the amounts appropriated under 
        subsection (a) \1\ for a fiscal year, the Secretary 
        shall reserve not less than $600,000 for conducting 
        health professions research and for carrying out data 
        collection and analysis in accordance with section 792.
---------------------------------------------------------------------------
    \1\ The reference to ``subsection (a)'' in subsection (e)(2) 
probably should read ``paragraph (1)''. Paragraph (4) of section 
5103(a) of PL 111-148 probably should have been designated as a 
subparagraph (B) of paragraph (3) of such section. As such, the 
amendment instruction in paragraph (4) to strike ``subsection (a)'' and 
insert ``paragraph (1)'' could not be executed since it did not specify 
to which subsection to carry out the amendment.
---------------------------------------------------------------------------
            (3) Availability of additional funds.--Amounts 
        otherwise appropriated for programs or activities under 
        this title may be used for activities under subsection 
        (b) with respect to the programs or activities from 
        which such amounts were made available.

SEC. 762. [294O] ADVISORY COUNCIL ON GRADUATE MEDICAL EDUCATION.

    (a) Establishment; Duties.--There is established the 
Council on Graduate Medical Education (in this section referred 
to as the ``Council''). The Council shall--
            (1) make recommendations to the Secretary of Health 
        and Human Services (in this section referred to as the 
        ``Secretary''), and to the Committee on Labor and Human 
        Resources of the Senate, and the Committee on Energy 
        and Commerce of the House of Representatives, with 
        respect to--
                    (A) the supply and distribution of 
                physicians in the United States;
                    (B) current and future shortages or 
                excesses of physicians in medical and surgical 
                specialties and subspecialties;
                    (C) issues relating to foreign medical 
                school graduates;
                    (D) appropriate Federal policies with 
                respect to the matters specified in 
                subparagraphs (A), (B), and (C), including 
                policies concerning changes in the financing of 
                undergraduate and graduate medical education 
                programs and changes in the types of medical 
                education training in graduate medical 
                education programs;
                    (E) appropriate efforts to be carried out 
                by hospitals, schools of medicine, schools of 
                osteopathic medicine, and accrediting bodies 
                with respect to the matters specified in 
                subparagraphs (A), (B), and (C), including 
                efforts for changes in undergraduate and 
                graduate medical education programs; and
                    (F) deficiencies in, and needs for 
                improvements in, existing data bases concerning 
                the supply and distribution of, and 
                postgraduate training programs for, physicians 
                in the United States and steps that should be 
                taken to eliminate those deficiencies;
            (2) encourage entities providing graduate medical 
        education to conduct activities to voluntarily achieve 
        the recommendations of the Council under paragraph 
        (1)(E);
            (3) develop, publish, and implement performance 
        measures for programs under this title, except for 
        programs under part C or D;
            (4) develop and publish guidelines for longitudinal 
        evaluations (as described in section 761(d)(2)) for 
        programs under this title, except for programs under 
        part C or D; and
            (5) recommend appropriation levels for programs 
        under this title, except for programs under part C or 
        D.
    (b) Composition.--The Council shall be composed of--
            (1) the Assistant Secretary for Health or the 
        designee of the Assistant Secretary;
            (2) the Administrator of the Health Care Financing 
        Administration;
            (3) the Chief Medical Director of the Department of 
        Veterans Affairs;
            (4) 6 members appointed by the Secretary to include 
        representatives of practicing primary care physicians, 
        national and specialty physician organizations, foreign 
        medical graduates, and medical student and house staff 
        associations;
            (5) 4 members appointed by the Secretary to include 
        representatives of schools of medicine and osteopathic 
        medicine and public and private teaching hospitals; and
            (6) 4 members appointed by the Secretary to include 
        representatives of health insurers, business, and 
        labor.
    (c) Terms of Appointed Members.--
            (1) In general; staggered rotation.--Members of the 
        Council appointed under paragraphs (4), (5), and (6) of 
        subsection (b) shall be appointed for a term of 4 
        years, except that the term of office of the members 
        first appointed shall expire, as designated by the 
        Secretary at the time of appointment, 4 at the end of 1 
        year, 4 at the end of 2 years, 3 at the end of 3 years, 
        and 3 at the end of 4 years.
            (2) Date certain for appointment.--The Secretary 
        shall appoint the first members to the Council under 
        paragraphs (4), (5), and (6) of subsection (b) within 
        60 days after the date of enactment of this section.
    (d) Chair.--The Council shall elect one of its members as 
Chairman of the Council.
    (e) Quorum.--Nine members of the Council shall constitute a 
quorum, but a lesser number may hold hearings.
    (f) Vacancies.--Any vacancy in the Council shall not affect 
its power to function.
    (g) Compensation.--Each member of the Council who is not 
otherwise employed by the United States Government shall 
receive compensation at a rate equal to the daily rate 
prescribed for GS-18 under the General Schedule under section 
5332 of title 5, United States Code, for each day, including 
traveltime, such member is engaged in the actual performance of 
duties as a member of the Council. A member of the Council who 
is an officer or employee of the United States Government shall 
serve without additional compensation. All members of the 
Council shall be reimbursed for travel, subsistence, and other 
necessary expenses incurred by them in the performance of their 
duties.
    (h) Certain Authorities and Duties.--
            (1) Authorities.--In order to carry out the 
        provisions of this section, the Council is authorized 
        to--
                    (A) collect such information, hold such 
                hearings, and sit and act at such times and 
                places, either as a whole or by subcommittee, 
                and request the attendance and testimony of 
                such witnesses and the production of such 
                books, records, correspondence, memoranda, 
                papers, and documents as the Council or such 
                subcommittee may consider available; and
                    (B) request the cooperation and assistance 
                of Federal departments, agencies, and 
                instrumentalities, and such departments, 
                agencies, and instrumentalities are authorized 
                to provide such cooperation and assistance.
            (2) Coordination of activities.--The Council shall 
        coordinate its activities with the activities of the 
        Secretary under section 792 of the Public Health 
        Service Act. The Secretary shall, in cooperation with 
        the Council and pursuant to the recommendations of the 
        Council, take such steps as are practicable to 
        eliminate deficiencies in the data base established 
        under such section 792 and shall make available in its 
        reports such comprehensive data sets as are developed 
        pursuant to this section.
    (i) Requirement Regarding Reports.--In the reports required 
under subsection (a), the Council shall specify its activities 
during the period for which the report is made.
    (j) Final Report.--Not later than April 1, 2002, the 
Council shall submit a final report under subsection (a).
    (k)  Termination.--The  Council  shall  terminate  
September 30, 2003 \1\.
---------------------------------------------------------------------------
    \1\ Appropriations Acts for the Department of Health and Human 
Services for fiscal years 2004 and 2005 provided for the continued 
operation of the Council. See section 219 of division E of Public Law 
108-199 (118 Stat. 255) and section 218 of division F of Public Law 
108-447 (118 Stat. 3141). Each of such sections refers to ``the Council 
on Graduate Education established by section 301 of Public Law 102-
408''. Such section 301 was transferred to the Public Health Service 
Act as section 762 above by section 104(b) of Public Law 105-392 (112 
Stat. 3552).
---------------------------------------------------------------------------
    (l) Funding.--Amounts otherwise appropriated under this 
title may be utilized by the Secretary to support the 
activities of the Council.

SEC. 763. [294P] PEDIATRIC RHEUMATOLOGY.

    (a) In General.--The Secretary, acting through the 
appropriate agencies, shall evaluate whether the number of 
pediatric rheumatologists is sufficient to address the health 
care needs of children with arthritis and related conditions, 
and if the Secretary determines that the number is not 
sufficient, shall develop strategies to help address the 
shortfall.
    (b) Report to Congress.--Not later than October 1, 2001, 
the Secretary shall submit to the Congress a report describing 
the results of the evaluation under subsection (a), and as 
applicable, the strategies developed under such subsection.
    (c) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2001 through 2005.

                   Subpart 2--Public Health Workforce

SEC. 765. [295] GENERAL PROVISIONS.

    (a) In General.--The Secretary may award grants or 
contracts to eligible entities to increase the number of 
individuals in the public health workforce, to enhance the 
quality of such workforce, and to enhance the ability of the 
workforce to meet national, State, and local health care needs.
    (b) Eligibility.--To be eligible to receive a grant or 
contract under subsection (a) an entity shall--
            (1) be--
                    (A) a health professions school, including 
                an accredited school or program of public 
                health, health administration, preventive 
                medicine, or dental public health or a school 
                providing health management programs;
                    (B) an academic health center;
                    (C) a State or local government; or
                    (D) any other appropriate public or private 
                nonprofit entity; and
            (2) prepare and submit to the Secretary an 
        application at such time, in such manner, and 
        containing such information as the Secretary may 
        require.
    (c) Preference.--In awarding grants or contracts under this 
section the Secretary may grant a preference to entities--
            (1) serving individuals who are from disadvantaged 
        backgrounds (including underrepresented racial and 
        ethnic minorities); and
            (2) graduating large proportions of individuals who 
        serve in underserved communities.
    (d) Activities.--Amounts provided under a grant or contract 
awarded under this section may be used for--
            (1) the costs of planning, developing, or operating 
        demonstration training programs;
            (2) faculty development;
            (3) trainee support;
            (4) technical assistance;
            (5) to meet the costs of projects--
                    (A) to plan and develop new residency 
                training programs and to maintain or improve 
                existing residency training programs in 
                preventive medicine and dental public health, 
                that have available full-time faculty members 
                with training and experience in the fields of 
                preventive medicine and dental public health; 
                and
                    (B) to provide financial assistance to 
                residency trainees enrolled in such programs;
            (6) the retraining of existing public health 
        workers as well as for increasing the supply of new 
        practitioners to address priority public health, 
        preventive medicine, public health dentistry, and 
        health administration needs;
            (7) preparing public health professionals for 
        employment at the State and community levels;
            (8) public health workforce loan repayment 
        programs; or
            (9) other activities that may produce outcomes that 
        are consistent with the purposes of this section.
    (e) Traineeships.--
            (1) In general.--With respect to amounts used under 
        this section for the training of health professionals, 
        such training programs shall be designed to--
                    (A) make public health education more 
                accessible to the public and private health 
                workforce;
                    (B) increase the relevance of public health 
                academic preparation to public health practice 
                in the future;
                    (C) provide education or training for 
                students from traditional on-campus programs in 
                practice-based sites; or
                    (D) develop educational methods and 
                distance-based approaches or technology that 
                address adult learning requirements and 
                increase knowledge and skills related to 
                community-based cultural diversity in public 
                health education.
            (2) Severe shortage disciplines.--Amounts provided 
        under grants or contracts under this section may be 
        used for the operation of programs designed to award 
        traineeships to students in accredited schools of 
        public health who enter educational programs in fields 
        where there is a severe shortage of public health 
        professionals, including epidemiology, biostatistics, 
        environmental health, toxicology, public health 
        nursing, nutrition, preventive medicine, maternal and 
        child health, and behavioral and mental health 
        professions.

SEC. 766. [295A] PUBLIC HEALTH TRAINING CENTERS.

    (a) In General.--The Secretary may make grants or contracts 
for the operation of public health training centers.
    (b) Eligible Entities.--
            (1) In general.--A public health training center 
        shall be an accredited school of public health, or 
        another public or nonprofit private institution 
        accredited for the provision of graduate or specialized 
        training in public health, that plans, develops, 
        operates, and evaluates projects that are in 
        furtherance of the goals established by the Secretary 
        for the year 2000 in the areas of preventive medicine, 
        health promotion and disease prevention, or improving 
        access to and quality of health services in medically 
        underserved communities.
            (2) Preference.--In awarding grants or contracts 
        under this section the Secretary shall give preference 
        to accredited schools of public health.
    (c) Certain Requirements.--With respect to a public health 
training center, an award may not be made under subsection (a) 
unless the program agrees that it--
            (1) will establish or strengthen field placements 
        for students in public or nonprofit private health 
        agencies or organizations;
            (2) will involve faculty members and students in 
        collaborative projects to enhance public health 
        services to medically underserved communities;
            (3) will specifically designate a geographic area 
        or medically underserved population to be served by the 
        center that shall be in a location removed from the 
        main location of the teaching facility of the school 
        that is participating in the program with such center; 
        and
            (4) will assess the health personnel needs of the 
        area to be served by the center and assist in the 
        planning and development of training programs to meet 
        such needs.

SEC. 767. [295B] PUBLIC HEALTH TRAINEESHIPS.

    (a) In General.--The Secretary may make grants to 
accredited schools of public health, and to other public or 
nonprofit private institutions accredited for the provision of 
graduate or specialized training in public health, for the 
purpose of assisting such schools and institutions in providing 
traineeships to individuals described in subsection (b)(3).
    (b) Certain Requirements.--
            (1) Amount.--The amount of any grant under this 
        section shall be determined by the Secretary.
            (2) Use of grant.--Traineeships awarded under 
        grants made under subsection (a) shall provide for 
        tuition and fees and such stipends and allowances 
        (including travel and subsistence expenses and 
        dependency allowances) for the trainees as the 
        Secretary may deem necessary.
            (3) Eligible individuals.--The individuals referred 
        to in subsection (a) are individuals who are pursuing a 
        course of study in a health professions field in which 
        there is a severe shortage of health professionals 
        (which fields include the fields of epidemiology, 
        environmental health, biostatistics, toxicology, 
        nutrition, and maternal and child health).

SEC. 768. [295C] PREVENTIVE MEDICINE AND PUBLIC HEALTH TRAINING GRANT 
                    PROGRAM.

    (a) Grants.--The Secretary, acting through the 
Administrator of the Health Resources and Services 
Administration and in consultation with the Director of the 
Centers for Disease Control and Prevention, shall award grants 
to, or enter into contracts with, eligible entities to provide 
training to graduate medical residents in preventive medicine 
specialties.
    (b) Eligibility.--To be eligible for a grant or contract 
under subsection (a), an entity shall be--
            (1) an accredited school of public health or school 
        of medicine or osteopathic medicine;
            (2) an accredited public or private nonprofit 
        hospital;
            (3) a State, local, or tribal health department; or
            (4) a consortium of 2 or more entities described in 
        paragraphs (1) through (3).
    (c) Use of Funds.--Amounts received under a grant or 
contract under this section shall be used to--
            (1) plan, develop (including the development of 
        curricula), operate, or participate in an accredited 
        residency or internship program in preventive medicine 
        or public health;
            (2) defray the costs of practicum experiences, as 
        required in such a program; and
            (3) establish, maintain, or improve--
                    (A) academic administrative units 
                (including departments, divisions, or other 
                appropriate units) in preventive medicine and 
                public health; or
                    (B) programs that improve clinical teaching 
                in preventive medicine and public health.
    (d) Report.--The Secretary shall submit to the Congress an 
annual report on the program carried out under this section.

SEC. 769. [295D] HEALTH ADMINISTRATION TRAINEESHIPS AND SPECIAL 
                    PROJECTS.

    (a) In General.--The Secretary may make grants to State or 
local governments (that have in effect preventive medical and 
dental public health residency programs) or public or nonprofit 
private educational entities (including graduate schools of 
social work and business schools that have health management 
programs) that offer a program described in subsection (b)--
            (1) to provide traineeships for students enrolled 
        in such a program; and
            (2) to assist accredited programs health 
        administration in the development or improvement of 
        programs to prepare students for employment with public 
        or nonprofit private entities.
    (b) Relevant Programs.--The program referred to in 
subsection (a) is an accredited program in health 
administration, hospital administration, or health policy 
analysis and planning, which program is accredited by a body or 
bodies approved for such purpose by the Secretary of Education 
and which meets such other quality standards as the Secretary 
of Health and Human Services by regulation may prescribe.
    (c) Preference in Making Grants.--In making grants under 
subsection (a), the Secretary shall give preference to 
qualified applicants that meet the following conditions:
            (1) Not less than 25 percent of the graduates of 
        the applicant are engaged in full-time practice 
        settings in medically underserved communities.
            (2) The applicant recruits and admits students from 
        medically underserved communities.
            (3) For the purpose of training students, the 
        applicant has established relationships with public and 
        nonprofit providers of health care in the community 
        involved.
            (4) In training students, the applicant emphasizes 
        employment with public or nonprofit private entities.
    (d) Certain Provisions Regarding Traineeships.--
            (1) Use of grant.--Traineeships awarded under 
        grants made under subsection (a) shall provide for 
        tuition and fees and such stipends and allowances 
        (including travel and subsistence expenses and 
        dependency allowances) for the trainees as the 
        Secretary may deem necessary.
            (2) Preference for certain students.--Each entity 
        applying for a grant under subsection (a) for 
        traineeships shall assure to the satisfaction of the 
        Secretary that the entity will give priority to 
        awarding the traineeships to students who demonstrate a 
        commitment to employment with public or nonprofit 
        private entities in the fields with respect to which 
        the traineeships are awarded.

SEC. 770. [295E] AUTHORIZATION OF APPROPRIATIONS.

    (a) In General.--For the purpose of carrying out this 
subpart, there is authorized to be appropriated $43,000,000 for 
fiscal year 2011, and such sums as may be necessary for each of 
the fiscal years 2012 through 2015.
    (b) Limitation Regarding Certain Program.--In obligating 
amounts appropriated under subsection (a), the Secretary may 
not obligate more than 30 percent for carrying out section 767.

             Subpart 3--Recruitment and Retention Programs

SEC. 775. [295F] INVESTMENT IN TOMORROW'S PEDIATRIC HEALTH CARE 
                    WORKFORCE.

    (a) Establishment.--The Secretary shall establish and carry 
out a pediatric specialty loan repayment program under which 
the eligible individual agrees to be employed full-time for a 
specified period (which shall not be less than 2 years) in 
providing pediatric medical subspecialty, pediatric surgical 
specialty, or child and adolescent mental and behavioral health 
care, including substance abuse prevention and treatment 
services.
    (b) Program Administration.--Through the program 
established under this section, the Secretary shall enter into 
contracts with qualified health professionals under which--
            (1) such qualified health professionals will agree 
        to provide pediatric medical subspecialty, pediatric 
        surgical specialty, or child and adolescent mental and 
        behavioral health care in an area with a shortage of 
        the specified pediatric subspecialty that has a 
        sufficient pediatric population to support such 
        pediatric subspecialty, as determined by the Secretary; 
        and
            (2) the Secretary agrees to make payments on the 
        principal and interest of undergraduate, graduate, or 
        graduate medical education loans of professionals 
        described in paragraph (1) of not more than $35,000 a 
        year for each year of agreed upon service under such 
        paragraph for a period of not more than 3 years during 
        the qualified health professional's--
                    (A) participation in an accredited 
                pediatric medical subspecialty, pediatric 
                surgical specialty, or child and adolescent 
                mental health subspecialty residency or 
                fellowship; or
                    (B) employment as a pediatric medical 
                subspecialist, pediatric surgical specialist, 
                or child and adolescent mental health 
                professional serving an area or population 
                described in such paragraph.
    (c) In General.--
            (1) Eligible individuals.--
                    (A) Pediatric medical specialists and 
                pediatric surgical specialists.--For purposes 
                of contracts with respect to pediatric medical 
                specialists and pediatric surgical specialists, 
                the term ``qualified health professional'' 
                means a licensed physician who--
                            (i) is entering or receiving 
                        training in an accredited pediatric 
                        medical subspecialty or pediatric 
                        surgical specialty residency or 
                        fellowship; or
                            (ii) has completed (but not prior 
                        to the end of the calendar year in 
                        which this section is enacted) the 
                        training described in subparagraph (B).
                    (B) Child and adolescent mental and 
                behavioral health.--For purposes of contracts 
                with respect to child and adolescent mental and 
                behavioral health care, the term ``qualified 
                health professional'' means a health care 
                professional who--
                            (i) has received specialized 
                        training or clinical experience in 
                        child and adolescent mental health in 
                        psychiatry, psychology, school 
                        psychology, behavioral pediatrics, 
                        psychiatric nursing, social work, 
                        school social work, substance abuse 
                        disorder prevention and treatment, 
                        marriage and family therapy, school 
                        counseling, or professional counseling;
                            (ii) has a license or certification 
                        in a State to practice allopathic 
                        medicine, osteopathic medicine, 
                        psychology, school psychology, 
                        psychiatric nursing, social work, 
                        school social work, marriage and family 
                        therapy, school counseling, or 
                        professional counseling; or
                            (iii) is a mental health service 
                        professional who completed (but not 
                        before the end of the calendar year in 
                        which this section is enacted) 
                        specialized training or clinical 
                        experience in child and adolescent 
                        mental health described in clause (i).
            (2) Additional eligibility requirements.--The 
        Secretary may not enter into a contract under this 
        subsection with an eligible individual unless--
                    (A) the individual agrees to work in, or 
                for a provider serving, a health professional 
                shortage area or medically underserved area, or 
                to serve a medically underserved population;
                    (B) the individual is a United States 
                citizen or a permanent legal United States 
                resident; and
                    (C) if the individual is enrolled in a 
                graduate program, the program is accredited, 
                and the individual has an acceptable level of 
                academic standing (as determined by the 
                Secretary).
    (d) Priority.--In entering into contracts under this 
subsection, the Secretary shall give priority to applicants 
who--
            (1) are or will be working in a school or other 
        pre-kindergarten, elementary, or secondary education 
        setting;
            (2) have familiarity with evidence-based methods 
        and cultural and linguistic competence health care 
        services; and
            (3) demonstrate financial need.
    (e) Authorization of Appropriations.--There is authorized 
to be appropriated $30,000,000 for each of fiscal years 2010 
through 2014 to carry out subsection (c)(1)(A) and $20,000,000 
for each of fiscal years 2010 through 2013 to carry out 
subsection (c)(1)(B).

SEC. 776. [295F-1] PUBLIC HEALTH WORKFORCE LOAN REPAYMENT PROGRAM.

    (a) Establishment.--The Secretary shall establish the 
Public Health Workforce Loan Repayment Program (referred to in 
this section as the ``Program'') to assure an adequate supply 
of public health professionals to eliminate critical public 
health workforce shortages in Federal, State, local, and tribal 
public health agencies.
    (b) Eligibility.--To be eligible to participate in the 
Program, an individual shall--
            (1)(A) be accepted for enrollment, or be enrolled, 
        as a student in an accredited academic educational 
        institution in a State or territory in the final year 
        of a course of study or program leading to a public 
        health or health professions degree or certificate; and 
        have accepted employment with a Federal, State, local, 
        or tribal public health agency, or a related training 
        fellowship, as recognized by the Secretary, to commence 
        upon graduation; \1\
---------------------------------------------------------------------------
    \1\ So in law. There should probably be an ``or'' at the end of 
subparagraph (A).
---------------------------------------------------------------------------
            (B)(i) have graduated, during the preceding 10-year 
        period, from an accredited educational institution in a 
        State or territory and received a public health or 
        health professions degree or certificate; and
            (ii) be employed by, or have accepted employment 
        with, a Federal, State, local, or tribal public health 
        agency or a related training fellowship, as recognized 
        by the Secretary;
            (2) be a United States citizen; and
            (3)(A) submit an application to the Secretary to 
        participate in the Program;
            (B) execute a written contract as required in 
        subsection (c); and
            (4) not have received, for the same service, a 
        reduction of loan obligations under section 455(m), 
        428J, 428K, 428L, or 460 of the Higher Education Act of 
        1965.
    (c) Contract.--The written contract (referred to in this 
section as the ``written contract'') between the Secretary and 
an individual shall contain--
            (1) an agreement on the part of the Secretary that 
        the Secretary will repay on behalf of the individual 
        loans incurred by the individual in the pursuit of the 
        relevant degree or certificate in accordance with the 
        terms of the contract;
            (2) an agreement on the part of the individual that 
        the individual will serve in the full-time employment 
        of a Federal, State, local, or tribal public health 
        agency or a related fellowship program in a position 
        related to the course of study or program for which the 
        contract was awarded for a period of time (referred to 
        in this section as the `period of obligated service') 
        equal to the greater of--
                    (A) 3 years; or
                    (B) such longer period of time as 
                determined appropriate by the Secretary and the 
                individual;
            (3) an agreement, as appropriate, on the part of 
        the individual to relocate to a priority service area 
        (as determined by the Secretary) in exchange for an 
        additional loan repayment incentive amount to be 
        determined by the Secretary;
            (4) a provision that any financial obligation of 
        the United States arising out of a contract entered 
        into under this section and any obligation of the 
        individual that is conditioned thereon, is contingent 
        on funds being appropriated for loan repayments under 
        this section;
            (5) a statement of the damages to which the United 
        States is entitled, under this section for the 
        individual's breach of the contract; and
            (6) such other statements of the rights and 
        liabilities of the Secretary and of the individual, not 
        inconsistent with this section.
    (d) Payments.--
            (1) In general.--A loan repayment provided for an 
        individual under a written contract under the Program 
        shall consist of payment, in accordance with paragraph 
        (2), on behalf of the individual of the principal, 
        interest, and related expenses on government and 
        commercial loans received by the individual regarding 
        the undergraduate or graduate education of the 
        individual (or both), which loans were made for tuition 
        expenses incurred by the individual.
            (2) Payments for years served.--For each year of 
        obligated service that an individual contracts to serve 
        under subsection (c) the Secretary may pay up to 
        $35,000 on behalf of the individual for loans described 
        in paragraph (1). With respect to participants under 
        the Program whose total eligible loans are less than 
        $105,000, the Secretary shall pay an amount that does 
        not exceed \1/3\ of the eligible loan balance for each 
        year of obligated service of the individual.
            (3) Tax liability.--For the purpose of providing 
        reimbursements for tax liability resulting from 
        payments under paragraph (2) on behalf of an 
        individual, the Secretary shall, in addition to such 
        payments, make payments to the individual in an amount 
        not to exceed 39 percent of the total amount of loan 
        repayments made for the taxable year involved.
    (e) Postponing Obligated Service.--With respect to an 
individual receiving a degree or certificate from a health 
professions or other related school, the date of the initiation 
of the period of obligated service may be postponed as approved 
by the Secretary.
    (f) Breach of Contract.--An individual who fails to comply 
with the contract entered into under subsection (c) shall be 
subject to the same financial penalties as provided for under 
section 338E for breaches of loan repayment contracts under 
section 338B.
    (g) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section $195,000,000 for 
fiscal year 2010, and such sums as may be necessary for each of 
fiscal years 2011 through 2015.

SEC. 777. [295F-2] TRAINING FOR MID-CAREER PUBLIC AND ALLIED HEALTH 
                    PROFESSIONALS.

    (a) In General.--The Secretary may make grants to, or enter 
into contracts with, any eligible entity to award scholarships 
to eligible individuals to enroll in degree or professional 
training programs for the purpose of enabling mid-career 
professionals in the public health and allied health workforce 
to receive additional training in the field of public health 
and allied health.
    (b) Eligibility.--
            (1) Eligible entity.--The term ``eligible entity'' 
        indicates an accredited educational institution that 
        offers a course of study, certificate program, or 
        professional training program in public or allied 
        health or a related discipline, as determined by the 
        Secretary
            (2) Eligible individuals.--The term ``eligible 
        individuals'' includes those individuals employed in 
        public and allied health positions at the Federal, 
        State, tribal, or local level who are interested in 
        retaining or upgrading their education.
    (c) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section, $60,000,000 for 
fiscal year 2010 and such sums as may be necessary for each of 
fiscal years 2011 through 2015. Fifty percent of appropriated 
funds shall be allotted to public health mid-career 
professionals and 50 percent shall be allotted to allied health 
mid-career professionals.

SEC. 778. [295F-3] FELLOWSHIP TRAINING IN APPLIED PUBLIC HEALTH 
                    EPIDEMIOLOGY, PUBLIC HEALTH LABORATORY SCIENCE, 
                    PUBLIC HEALTH INFORMATICS, AND EXPANSION OF THE 
                    EPIDEMIC INTELLIGENCE SERVICE.

    (a) In General.--The Secretary may carry out activities to 
address documented workforce shortages in State and local 
health departments in the critical areas of applied public 
health epidemiology and public health laboratory science and 
informatics and may expand the Epidemic Intelligence Service.
    (b) Specific Uses.--In carrying out subsection (a), the 
Secretary shall provide for the expansion of existing 
fellowship programs operated through the Centers for Disease 
Control and Prevention in a manner that is designed to 
alleviate shortages of the type described in subsection (a).
    (c) Other Programs.--The Secretary may provide for the 
expansion of other applied epidemiology training programs that 
meet objectives similar to the objectives of the programs 
described in subsection (b).
    (d) Work Obligation.--Participation in fellowship training 
programs under this section shall be deemed to be service for 
purposes of satisfying work obligations stipulated in contracts 
under section 338I(j).
    (e) General Support.--Amounts may be used from grants 
awarded under this section to expand the Public Health 
Informatics Fellowship Program at the Centers for Disease 
Control and Prevention to better support all public health 
systems at all levels of government.
    (f) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section $39,500,000 for 
each of fiscal years 2010 through 2013, of which--
            (1) $5,000,000 shall be made available in each such 
        fiscal year for epidemiology fellowship training 
        program activities under subsections (b) and (c);
            (2) $5,000,000 shall be made available in each such 
        fiscal year for laboratory fellowship training programs 
        under subsection (b);
            (3) $5,000,000 shall be made available in each such 
        fiscal year for the Public Health Informatics 
        Fellowship Program under subsection (e); and
            (4) $24,500,000 shall be made available for 
        expanding the Epidemic Intelligence Service under 
        subsection (a).

                       PART F--GENERAL PROVISIONS

SEC. 791. [295J] PREFERENCES AND REQUIRED INFORMATION IN CERTAIN 
                    PROGRAMS.

    (a) Preferences in Making Awards.--
            (1) In general.--Subject to paragraph (2), in 
        making awards of grants or contracts under any of 
        sections 747 and 750, the Secretary shall give 
        preference to any qualified applicant that--
                    (A) has a high rate for placing graduates 
                in practice settings having the principal focus 
                of serving residents of medically underserved 
                communities;
                    (B) during the 2-year period preceding the 
                fiscal year for which such an award is sought, 
                has achieved a significant increase in the rate 
                of placing graduates in such settings; or
                    (C) utilizes a longitudinal evaluation (as 
                described in section 761(d)(2)) and reports 
                data from such system to the national workforce 
                database (as established under section 
                761(b)(2)(E)).
            (2) Limitation regarding peer review.--For purposes 
        of paragraph (1), the Secretary may not give an 
        applicant preference if the proposal of the applicant 
        is ranked at or below the 20th percentile of proposals 
        that have been recommended for approval by peer review 
        groups.
    (b) Definition.--For purposes of this section, the term 
``graduate'' means, unless otherwise specified, an individual 
who has successfully completed all training and residency 
requirements necessary for full certification in the health 
profession selected by the individual.
    (c) Exceptions for New Programs.--
            (1) In general.--To permit new programs to compete 
        equitably for funding under this section, those new 
        programs that meet at least 4 of the criteria described 
        in paragraph (3) shall qualify for a funding preference 
        under this section.
            (2) Definition.--As used in this subsection, the 
        term ``new program'' means any program that has 
        graduated less than three classes. Upon graduating at 
        least three classes, a program shall have the 
        capability to provide the information necessary to 
        qualify the program for the general funding preferences 
        described in subsection (a).
            (3) Criteria.--The criteria referred to in 
        paragraph (1) are the following:
                    (A) The mission statement of the program 
                identifies a specific purpose of the program as 
                being the preparation of health professionals 
                to serve underserved populations.
                    (B) The curriculum of the program includes 
                content which will help to prepare 
                practitioners to serve underserved populations.
                    (C) Substantial clinical training 
                experience is required under the program in 
                medically underserved communities.
                    (D) A minimum of 20 percent of the clinical 
                faculty of the program spend at least 50 
                percent of their time providing or supervising 
                care in medically underserved communities.
                    (E) The entire program or a substantial 
                portion of the program is physically located in 
                a medically underserved community.
                    (F) Student assistance, which is linked to 
                service in medically underserved communities 
                following graduation, is available to the 
                students in the program.
                    (G) The program provides a placement 
                mechanism for deploying graduates to medically 
                underserved communities.

SEC. 792. [295K] HEALTH PROFESSIONS DATA.

    (a) In General.--The Secretary shall establish a program, 
including a uniform health professions data reporting system, 
to collect, compile, and analyze data on health professions 
personnel which program shall initially include data respecting 
all physicians and dentists in the States. The Secretary is 
authorized to expand the program to include, whenever he 
determines it necessary, the collection, compilation, and 
analysis of data respecting pharmacists, optometrists, 
podiatrists, veterinarians, public health personnel, 
audiologists, speech pathologists, health care administration 
personnel, nurses, allied health personnel, medical 
technologists, chiropractors, clinical psychologists, 
professional counselors, and any other health personnel in 
States designated by the Secretary to be included in the 
program. Such data shall include data respecting the training, 
licensure status (including permanent, temporary, partial, 
limited, or institutional), place or places of practice, 
professional specialty, practice characteristics, place and 
date of birth, sex, and socioeconomic background of health 
professions personnel and such other demographic information 
regarding health professions personnel as the Secretary may 
require.
    (b) Certain Authorities and Requirements.--
            (1) Sources of information.--In carrying out 
        subsection (a), the Secretary shall collect available 
        information from appropriate local, State, and Federal 
        agencies and other appropriate sources.
            (2) Contracts for studies of health professions.--
        The Secretary shall conduct or enter into contracts for 
        the conduct of analytic and descriptive studies of the 
        health professions, including evaluations and 
        projections of the supply of, and requirements for, the 
        health professions by specialty and geographic 
        location. Such studies shall include studies 
        determining by specialty and geographic location the 
        number of health professionals (including allied health 
        professionals and health care administration personnel) 
        who are members of minority groups, including 
        Hispanics, and studies providing by specialty and 
        geographic location evaluations and projections of the 
        supply of, and requirements for, health professionals 
        (including allied health professionals and health care 
        administration personnel) to serve minority groups, 
        including Hispanics.
            (3) Grants and contracts regarding states.--The 
        Secretary is authorized to make grants and to enter 
        into contracts with States (or an appropriate nonprofit 
        private entity in any State) for the purpose of 
        participating in the program established under 
        subsection (a). The Secretary shall determine the 
        amount and scope of any such grant or contract. To be 
        eligible for a grant or contract under this paragraph a 
        State or entity shall submit an application in such 
        form and manner and containing such information as the 
        Secretary shall require. Such application shall include 
        reasonable assurance, satisfactory to the Secretary, 
        that--
                    (A) such State (or nonprofit entity within 
                a State) will establish a program of mandatory 
                annual registration of the health professions 
                personnel described in subsection (a) who 
                reside or practice in such State and of health 
                institutions licensed by such State, which 
                registration shall include such information as 
                the Secretary shall determine to be 
                appropriate;
                    (B) such State or entity shall collect such 
                information and report it to the Secretary in 
                such form and manner as the Secretary shall 
                prescribe; and
                    (C) such State or entity shall comply with 
                the requirements of subsection (e).
    (d) \1\ Reports to Congress.--The Secretary shall submit to 
the Congress on October 1, 1993, and biennially thereafter, the 
following reports:
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    \1\ So in law. Probably should be redesignated as (c).
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            (1) A comprehensive report regarding the status of 
        health personnel according to profession, including a 
        report regarding the analytic and descriptive studies 
        conducted under this section.
            (2) A comprehensive report regarding applicants to, 
        and students enrolled in, programs and institutions for 
        the training of health personnel, including 
        descriptions and analyses of student indebtedness, 
        student need for financial assistance, financial 
        resources to meet the needs of students, student career 
        choices such as practice specialty and geographic 
        location and the relationship, if any, between student 
        indebtedness and career choices.
    (e) \1\ Requirements Regarding Personal Data.--
            (1) In general.--The Secretary and each program 
        entity shall in securing and maintaining any record of 
        individually identifiable personal data (hereinafter in 
        this subsection referred to as ``personal data'') for 
        purposes of this section--
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    \1\ So in law. Probably should be redesignated as (d).
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                    (A) inform any individual who is asked to 
                supply personal data whether he is legally 
                required, or may refuse, to supply such data 
                and inform him of any specific consequences, 
                known to the Secretary or program entity, as 
                the case may be, of providing or not providing 
                such data;
                    (B) upon request, inform any individual if 
                he is the subject of personal data secured or 
                maintained by the Secretary or program entity, 
                as the case may be, and make the data available 
                to him in a form comprehensible to him;
                    (C) assure that no use is made of personal 
                data which use is not within the purposes of 
                this section unless an informed consent has 
                been obtained from the individual who is the 
                subject of such data; and
                    (D) upon request, inform any individual of 
                the use being made of personal data respecting 
                such individual and of the identity of the 
                individuals and entities which will use the 
                data and their relationship to the programs 
                under this section.
            (2) Consent as precondition to disclosure.--Any 
        entity which maintains a record of personal data and 
        which receives a request from the Secretary or a 
        program entity for such data for purposes of this 
        section shall not transfer any such data to the 
        Secretary or to a program entity unless the individual 
        whose personal data is to be so transferred gives an 
        informed consent for such transfer.
            (3) Disclosure by secretary.--
                    (A) Notwithstanding any other provision of 
                law, personal data collected by the Secretary 
                or any program entity under this section may 
                not be made available or disclosed by the 
                Secretary or any program entity to any person 
                other than the individual who is the subject of 
                such data unless (i) such person requires such 
                data for purposes of this section, or (ii) in 
                response to a demand for such data made by 
                means of compulsory legal process. Any 
                individual who is the subject of personal data 
                made available or disclosed under clause (ii) 
                shall be notified of the demand for such data.
                    (B) Subject to all applicable laws 
                regarding confidentiality, only the data 
                collected by the Secretary under this section 
                which is not personal data shall be made 
                available to bona fide researchers and policy 
                analysts (including the Congress) for the 
                purposes of assisting in the conduct of studies 
                respecting health professions personnel.
            (4) Definition.--For purposes of this subsection, 
        the term ``program entity'' means any public or private 
        entity which collects, compiles, or analyzes health 
        professions data under a grant, contract, or other 
        arrangement with the Secretary under this section.
    (g) \1\ Technical Assistance.--The Secretary shall provide 
technical assistance to the States and political subdivisions 
thereof in the development of systems (including model laws) 
concerning confidentiality and comparability of data collected 
pursuant to this section.
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    \1\ So in law. Probably should be redesignated as (e).
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    (h) \2\ Grants and Contracts Regarding Nonprofit 
Entities.--
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    \2\ So in law. Probably should be redesignated as (f).
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            (1) In general.--In carrying out subsection (a), 
        the Secretary may make grants, or enter into contracts 
        and cooperative agreements with, and provide technical 
        assistance to, any nonprofit entity in order to 
        establish a uniform allied health professions data 
        reporting system to collect, compile, and analyze data 
        on the allied health professions personnel.
            (2) Reports.--With respect to reports required in 
        subsection (d), each such report made on or after 
        October 1, 1991, shall include a description and 
        analysis of data collected pursuant to paragraph (1).

SEC. 794. \3\ [295M] PROHIBITION AGAINST DISCRIMINATION ON BASIS OF 
                    SEX.
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    \3\ Section 793 was repealed by section 106(a)(2)(C) of Public Law 
105-392 (112 Stat. 3557).
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    The Secretary may not make a grant, loan guarantee, or 
interest subsidy payment under this title to, or for the 
benefit of, any school of medicine, osteopathic medicine, 
dentistry, veterinary medicine, optometry, pharmacy, podiatric 
medicine, or public health or any training center for allied 
health personnel, or graduate program in clinical psychology, 
unless the application for the grant, loan guarantee, or 
interest subsidy payment contains assurances satisfactory to 
the Secretary that the school or training center will not 
discriminate on the basis of sex in the admission of 
individuals to its training programs. The Secretary may not 
enter into a contract under this title with any such school or 
training center unless the school, training center, or graduate 
program furnishes assurances satisfactory to the Secretary that 
it will not discriminate on the basis of sex in the admission 
of individuals to its training programs. In the case of a 
school of medicine which--
            (1) on the date of the enactment of this sentence 
        is in the process of changing its status as an 
        institution which admits only female students to that 
        of an institution which admits students without regard 
        to their sex, and
            (2) is carrying out such change in accordance with 
        a plan approved by the Secretary,
the provisions of the preceding sentences of this section shall 
apply only with respect to a grant, contract, loan guarantee, 
or interest subsidy to, or for the benefit of such a school for 
a fiscal year beginning after June 30, 1979.

SEC. 796. \1\  [295N-1] APPLICATION.
---------------------------------------------------------------------------

    \1\ Section 795 was repealed by section 101(b)(1) of Public Law 
105-392 (112 Stat. 3537).
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    (a) In General.--To be eligible to receive a grant or 
contract under this title, an eligible entity shall prepare and 
submit to the Secretary an application that meets the 
requirements of this section, at such time, in such manner, and 
containing such information as the Secretary may require.
    (b) Plan.--An application submitted under this section 
shall contain the plan of the applicant for carrying out a 
project with amounts received under this title. Such plan shall 
be consistent with relevant Federal, State, or regional health 
professions program plans.
    (c) Performance Outcome Standards.--An application 
submitted under this section shall contain a specification by 
the applicant entity of performance outcome standards that the 
project to be funded under the grant or contract will be 
measured against. Such standards shall address relevant health 
workforce needs that the project will meet. The recipient of a 
grant or contract under this section shall meet the standards 
set forth in the grant or contract application.
    (d) Linkages.--An application submitted under this section 
shall contain a description of the linkages with relevant 
educational and health care entities, including training 
programs for other health professionals as appropriate, that 
the project to be funded under the grant or contract will 
establish. To the extent practicable, grantees under this 
section shall establish linkages with health care providers who 
provide care for underserved communities and populations.

SEC. 797. [295N-2] USE OF FUNDS.

    (a) In General.--Amounts provided under a grant or contract 
awarded under this title may be used for training program 
development and support, faculty development, model 
demonstrations, trainee support including tuition, books, 
program fees and reasonable living expenses during the period 
of training, technical assistance, workforce analysis, 
dissemination of information, and exploring new policy 
directions, as appropriate to meet recognized health workforce 
objectives, in accordance with this title.
    (b) Maintenance of Effort.--With respect to activities for 
which a grant awarded under this title is to be expended, the 
entity shall agree to maintain expenditures of non-Federal 
amounts for such activities at a level that is not less than 
the level of such expenditures maintained by the entity for the 
fiscal year preceding the fiscal year for which the entity 
receives such a grant.

SEC. 798. [295O] MATCHING REQUIREMENT.

    The Secretary may require that an entity that applies for a 
grant or contract under this title provide non-Federal matching 
funds, as appropriate, to ensure the institutional commitment 
of the entity to the projects funded under the grant. As 
determined by the Secretary, such non-Federal matching funds 
may be provided directly or through donations from public or 
private entities and may be in cash or in-kind, fairly 
evaluated, including plant, equipment, or services.

SEC. 799. [295O-1] GENERALLY APPLICABLE PROVISIONS.

    (a) Awarding of Grants and Contracts.--The Secretary shall 
ensure that grants and contracts under this title are awarded 
on a competitive basis, as appropriate, to carry out innovative 
demonstration projects or provide for strategic workforce 
supplementation activities as needed to meet health workforce 
goals and in accordance with this title. Contracts may be 
entered into under this title with public or private entities 
as may be necessary.
    (b) Eligible Entities.--Unless specifically required 
otherwise in this title, the Secretary shall accept 
applications for grants or contracts under this title from 
health professions schools, academic health centers, State or 
local governments, or other appropriate public or private 
nonprofit entities for funding and participation in health 
professions and nursing training activities. The Secretary may 
accept applications from for-profit private entities if 
determined appropriate by the Secretary.
    (c) Information Requirements.--
            (1) In general.--Recipients of grants and contracts 
        under this title shall meet information requirements as 
        specified by the Secretary.
            (2) Data collection.--The Secretary shall establish 
        procedures to ensure that, with respect to any data 
        collection required under this title, such data is 
        collected in a manner that takes into account age, sex, 
        race, and ethnicity.
            (3) Use of funds.--The Secretary shall establish 
        procedures to permit the use of amounts appropriated 
        under this title to be used for data collection 
        purposes.
            (4) Evaluations.--The Secretary shall establish 
        procedures to ensure the annual evaluation of programs 
        and projects operated by recipients of grants or 
        contracts under this title. Such procedures shall 
        ensure that continued funding for such programs and 
        projects will be conditioned upon a demonstration that 
        satisfactory progress has been made by the program or 
        project in meeting the objectives of the program or 
        project.
    (d) Training Programs.--Training programs conducted with 
amounts received under this title shall meet applicable 
accreditation and quality standards.
    (e) Duration of Assistance.--
            (1) In general.--Subject to paragraph (2), in the 
        case of an award to an entity of a grant, cooperative 
        agreement, or contract under this title, the period 
        during which payments are made to the entity under the 
        award may not exceed 5 years. The provision of payments 
        under the award shall be subject to annual approval by 
        the Secretary of the payments and subject to the 
        availability of appropriations for the fiscal year 
        involved to make the payments. This paragraph may not 
        be construed as limiting the number of awards under the 
        program involved that may be made to the entity.
            (2) Limitation.--In the case of an award to an 
        entity of a grant, cooperative agreement, or contract 
        under this title, paragraph (1) shall apply only to the 
        extent not inconsistent with any other provision of 
        this title that relates to the period during which 
        payments may be made under the award.
    (f) Peer Review Regarding Certain Programs.--
            (1) In general.--Each application for a grant under 
        this title, except any scholarship or loan program, 
        including those under sections \1\ 701, 721, or 723, 
        shall be submitted to a peer review group for an 
        evaluation of the merits of the proposals made in the 
        application. The Secretary may not approve such an 
        application unless a peer review group has recommended 
        the application for approval.
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    \1\ So in law. Probably should read ``section''.
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            (2) Composition.--Each peer review group under this 
        subsection shall be composed principally of individuals 
        who are not officers or employees of the Federal 
        Government. In providing for the establishment of peer 
        review groups and procedures, the Secretary shall 
        ensure sex, racial, ethnic, and geographic balance 
        among the membership of such groups.
            (3) Administration.--This subsection shall be 
        carried out by the Secretary acting through the 
        Administrator of the Health Resources and Services 
        Administration.
    (g) Preference or Priority Considerations.--In considering 
a preference or priority for funding which is based on outcome 
measures for an eligible entity under this title, the Secretary 
may also consider the future ability of the eligible entity to 
meet the outcome preference or priority through improvements in 
the eligible entity's program design.
    (h) Analytic Activities.--The Secretary shall ensure that--
            (1) cross-cutting workforce analytical activities 
        are carried out as part of the workforce information 
        and analysis activities under section 761; and
            (2) discipline-specific workforce information and 
        analytical activities are carried out as part of--
                    (A) the community-based linkage program 
                under part D; and
                    (B) the health workforce development 
                program under subpart 2 of part E.
    (i) Osteopathic Schools.--For purposes of this title, any 
reference to--
            (1) medical schools shall include osteopathic 
        medical schools; and
            (2) medical students shall include osteopathic 
        medical students.

SEC. 799A. [295O-2] TECHNICAL ASSISTANCE.

    Funds appropriated under this title may be used by the 
Secretary to provide technical assistance in relation to any of 
the authorities under this title.

SEC. 799B. [295P] DEFINITIONS.

    For purposes of this title:
            (1)(A) The terms ``school of medicine'', ``school 
        of dentistry'', ``school of osteopathic medicine'', 
        ``school of pharmacy'', ``school of optometry'', 
        ``school of podiatric medicine'', ``school of 
        veterinary medicine'', ``school of public health'', and 
        ``school of chiropractic'' mean an accredited public or 
        nonprofit private school in a State that provides 
        training leading, respectively, to a degree of doctor 
        of medicine, a degree of doctor of dentistry or an 
        equivalent degree, a degree of doctor of osteopathy, a 
        degree of bachelor of science in pharmacy or an 
        equivalent degree or a degree of doctor of pharmacy or 
        an equivalent degree, a degree of doctor of optometry 
        or an equivalent degree, a degree of doctor of 
        podiatric medicine or an equivalent degree, a degree of 
        doctor of veterinary medicine or an equivalent degree, 
        a graduate degree in public health or an equivalent 
        degree, and a degree of doctor of chiropractic or an 
        equivalent degree, and including advanced training 
        related to such training provided by any such school.
            (B) The terms ``graduate program in health 
        administration'' and ``graduate program in clinical 
        psychology'' mean an accredited graduate program in a 
        public or nonprofit private institution in a State that 
        provides training leading, respectively, to a graduate 
        degree in health administration or an equivalent degree 
        and a doctoral degree in clinical psychology or an 
        equivalent degree.
            (C) The terms ``graduate program in clinical social 
        work'' and ``graduate program in marriage and family 
        therapy'' and ``graduate program in professional 
        counseling'' mean an accredited graduate program in a 
        public or nonprofit private institution in a State that 
        provides training, respectively, in a concentration in 
        health or mental health care leading to a graduate 
        degree in social work and a concentration leading to a 
        graduate degree in marriage and family therapy and a 
        concentration leading to a graduate degree in 
        counseling.
            (D) \1\ The term ``graduate program in behavioral 
        health and mental health practice'' means a graduate 
        program in clinical psychology, clinical social work, 
        professional counseling, or marriage and family 
        therapy.
---------------------------------------------------------------------------
    \1\ Section 108(a)(2) of Public Law 105-392 (112 Stat. 3560) 
provides that paragraph (1)(D) is amended by inserting ``behavioral 
health and mental health practice,'' before ``clinical''. The amendment 
cannot be executed because the amendment does not specify to which 
instance of the term ``clinical'' the amendment applies.
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            (E) The term ``accredited'', when applied to a 
        school of medicine, osteopathic medicine, dentistry, 
        veterinary medicine, optometry, podiatry, pharmacy, 
        public health, or chiropractic, or a graduate program 
        in health administration, clinical psychology, clinical 
        social work, professional counseling, or marriage and 
        family therapy, means a school or program that is 
        accredited by a recognized body or bodies approved for 
        such purpose by the Secretary of Education, except that 
        a new school or program that, by reason of an 
        insufficient period of operation, is not, at the time 
        of application for a grant or contract under this 
        title, eligible for accreditation by such a recognized 
        body or bodies, shall be deemed accredited for purposes 
        of this title, if the Secretary of Education finds, 
        after consultation with the appropriate accreditation 
        body or bodies, that there is reasonable assurance that 
        the school or program will meet the accreditation 
        standards of such body or bodies prior to the beginning 
        of the academic year following the normal graduation 
        date of the first entering class in such school or 
        program.
            (2) The term ``teaching facilities'' means areas 
        dedicated for use by students, faculty, or 
        administrative or maintenance personnel for clinical 
        purposes, research activities, libraries, classrooms, 
        offices, auditoriums, dining areas, student activities, 
        or other related purposes necessary for, and 
        appropriate to, the conduct of comprehensive programs 
        of education. Such term includes interim facilities but 
        does not include off-site improvements or living 
        quarters.
            (3) Physician assistant education program.--The 
        term ``physician assistant education program'' means an 
        educational program in a public or private institution 
        in a State that--
                    (A) has as its objective the education of 
                individuals who, upon completion of their 
                studies in the program, be qualified to provide 
                primary care medical services with the 
                supervision of a physician; and
                    (B) is accredited by the Accreditation 
                Review Commission on Education for the 
                Physician Assistant.
            (4) The term ``school of allied health'' means a 
        public or nonprofit private college, junior college, or 
        university or hospital-based educational entity that--
                    (A) provides, or can provide, programs of 
                education to enable individuals to become 
                allied health professionals or to provide 
                additional training for allied health 
                professionals;
                    (B) provides training for not less than a 
                total of twenty persons in the allied health 
                curricula (except that this subparagraph shall 
                not apply to any hospital-based educational 
                entity);
                    (C) includes or is affiliated with a 
                teaching hospital; and
                    (D) is accredited by a recognized body or 
                bodies approved for such purposes by the 
                Secretary of Education, or which provides to 
                the Secretary satisfactory assurance by such 
                accrediting body or bodies that reasonable 
                progress is being made toward accreditation.
            (5) The term ``allied health professionals'' means 
        a health professional (other than a registered nurse or 
        physician assistant)--
                    (A) who has received a certificate, an 
                associate's degree, a bachelor's degree, a 
                master's degree, a doctoral degree, or 
                postbaccalaureate training, in a science 
                relating to health care;
                    (B) who shares in the responsibility for 
                the delivery of health care services or related 
                services, including--
                            (i) services relating to the 
                        identification, evaluation, and 
                        prevention of disease and disorders;
                            (ii) dietary and nutrition 
                        services;
                            (iii) health promotion services;
                            (iv) rehabilitation services; or
                            (v) health systems management 
                        services; and
                    (C) who has not received a degree of doctor 
                of medicine, a degree of doctor of osteopathy, 
                a degree of doctor of dentistry or an 
                equivalent degree, a degree of doctor of 
                veterinary medicine or an equivalent degree, a 
                degree of doctor of optometry or an equivalent 
                degree, a degree of doctor of podiatric 
                medicine or an equivalent degree, a degree of 
                bachelor of science in pharmacy or an 
                equivalent degree, a degree of doctor of 
                pharmacy or an equivalent degree, a graduate 
                degree in public health or an equivalent 
                degree, a degree of doctor of chiropractic or 
                an equivalent degree, a graduate degree in 
                health administration or an equivalent degree, 
                a doctoral degree in clinical psychology or an 
                equivalent degree, or a degree in social work 
                or an equivalent degree or a degree in 
                counseling or an equivalent degree.
            (6) The term ``medically underserved community'' 
        means an urban or rural area or population that--
                    (A) is eligible for designation under 
                section 332 as a health professional shortage 
                area;
                    (B) \1\ is eligible to be served by a 
                migrant health center under section 329, a 
                community health center under section 330, a 
                grantee under section 330(h) (relating to 
                homeless individuals), or a grantee under 
                section 340A (relating to residents of public 
                housing);
---------------------------------------------------------------------------
    \1\ See footnote for section 224(g)(1)(G)(ii).
---------------------------------------------------------------------------
                    (C) has a shortage of personal health 
                services, as determined under criteria issued 
                by the Secretary under section 1861(aa)(2) of 
                the Social Security Act (relating to rural 
                health clinics); or
                    (D) is designated by a State Governor (in 
                consultation with the medical community) as a 
                shortage area or medically underserved 
                community.
            (7) The term ``Department'' means the Department of 
        Health and Human Services.
            (8) The term ``nonprofit'' refers to the status of 
        an entity owned and operated by one or more 
        corporations or associations no part of the net 
        earnings of which inures, or may lawfully inure, to the 
        benefit of any private shareholder or individual.
            (9) The term ``State'' includes, in addition to the 
        several States, only the District of Columbia, the 
        Commonwealth of Puerto Rico, the Commonwealth of the 
        Northern Mariana Islands, the Virgin Islands, Guam, 
        American Samoa, and the Trust Territory of the Pacific 
        Islands.
            (10)(A) Subject to subparagraph (B), the term 
        ``underrepresented minorities'' means, with respect to 
        a health profession, racial and ethnic populations that 
        are underrepresented in the health profession relative 
        to the number of individuals who are members of the 
        population involved.
            (B) For purposes of subparagraph (A), Asian 
        individuals shall be considered by the various 
        subpopulations of such individuals.
            (11) The term ``psychologist'' means an individual 
        who--
                    (A) holds a doctoral degree in psychology; 
                and
                    (B) is licensed or certified on the basis 
                of the doctoral degree in psychology, by the 
                State in which the individual practices, at the 
                independent practice level of psychology to 
                furnish diagnostic, assessment, preventive, and 
                therapeutic services directly to individuals.
            (12) Area health education center.--The term ``area 
        health education center'' means a public or nonprofit 
        private organization that has a cooperative agreement 
        or contract in effect with an entity that has received 
        an award under subsection (a)(1) or (a)(2) of section 
        751, satisfies the requirements in section 751(d)(1), 
        and has as one of its principal functions the operation 
        of an area health education center. Appropriate 
        organizations may include hospitals, health 
        organizations with accredited primary care training 
        programs, accredited physician assistant educational 
        programs associated with a college or university, and 
        universities or colleges not operating a school of 
        medicine or osteopathic medicine.
            (13) Area health education center program.--The 
        term ``area health education center program'' means 
        cooperative program consisting of an entity that has 
        received an award under subsection (a)(1) or (a)(2) of 
        section 751 for the purpose of planning, developing, 
        operating, and evaluating an area health education 
        center program and one or more area health education 
        centers, which carries out the required activities 
        described in section 751(c), satisfies the program 
        requirements in such section, has as one of its 
        principal functions identifying and implementing 
        strategies and activities that address health care 
        workforce needs in its service area, in coordination 
        with the local workforce investment boards.
            (14) Clinical social worker.--The term ``clinical 
        social worker'' has the meaning given the term in 
        section 1861(hh)(1) of the Social Security Act (42 
        U.S.C. 1395x(hh)(1)).
            (15) Cultural competency.--The term ``cultural 
        competency'' shall be defined by the Secretary in a 
        manner consistent with section 1707(d)(3).
            (16) Direct care worker.--The term ``direct care 
        worker'' has the meaning given that term in the 2010 
        Standard Occupational Classifications of the Department 
        of Labor for Home Health Aides [31-1011], Psychiatric 
        Aides [31-1013], Nursing Assistants [31-1014], and 
        Personal Care Aides [39-9021].
            (17) Federally qualified health center.--The term 
        ``Federally qualified health center'' has the meaning 
        given that term in section 1861(aa) of the Social 
        Security Act (42 U.S.C. 1395x(aa)).
            (18) Frontier health professional shortage area.--
        The term ``frontier health professional shortage area'' 
        means an area--
                    (A) with a population density less than 6 
                persons per square mile within the service 
                area; and
                    (B) with respect to which the distance or 
                time for the population to access care is 
                excessive.
            (19) Graduate psychology.--The term ``graduate 
        psychology'' means an accredited program in 
        professional psychology.
            (20) Health disparity population.--The term 
        ``health disparity population'' has the meaning given 
        such term in section 903(d)(1).
            (21) Health literacy.--The term ``health literacy'' 
        means the degree to which an individual has the 
        capacity to obtain, communicate, process, and 
        understand health information and services in order to 
        make appropriate health decisions.
            (22) Mental health service professional.--The term 
        ``mental health service professional'' means an 
        individual with a graduate or postgraduate degree from 
        an accredited institution of higher education in 
        psychiatry, psychology, school psychology, behavioral 
        pediatrics, psychiatric nursing, social work, school 
        social work, substance abuse disorder prevention and 
        treatment, marriage and family counseling, school 
        counseling, or professional counseling.
            (23) One-stop delivery system center.--The term 
        ``one-stop delivery system'' means a one-stop delivery 
        system described in section 134(c) of the Workforce 
        Investment Act of 1998 (29 U.S.C. 2864(c)).
            (24) Paraprofessional child and adolescent mental 
        health worker.--The term ``paraprofessional child and 
        adolescent mental health worker'' means an individual 
        who is not a mental or behavioral health service 
        professional, but who works at the first stage of 
        contact with children and families who are seeking 
        mental or behavioral health services, including 
        substance abuse prevention and treatment services.
            (25) Racial and ethnic minority group; racial and 
        ethnic minority population.--The terms ``racial and 
        ethnic minority group'' and ``racial and ethnic 
        minority population'' have the meaning given the term 
        `racial and ethnic minority group' in section 1707.
            (26) Rural health clinic.--The term ``rural health 
        clinic'' has the meaning given that term in section 
        1861(aa) of the Social Security Act (42 U.S.C. 
        1395x(aa)).ATTORNEY: PMG/FD (June 24, 
        1999) deg.
               TITLE VIII--NURSING WORKFORCE DEVELOPMENT

                       PART A--GENERAL PROVISIONS

SEC. 801. [296] DEFINITIONS.

    As used in this title:
            (1) Eligible entities.--The term ``eligible 
        entities'' means schools of nursing, nursing centers, 
        academic health centers, State or local governments, 
        and other public or private nonprofit entities 
        determined appropriate by the Secretary that submit to 
        the Secretary an application in accordance with section 
        802.
            (2) School of nursing.--The term ``school of 
        nursing'' means an accredited (as defined in paragraph 
        6) collegiate, associate degree, or diploma school of 
        nursing in a State where graduates are--
                    (A) authorized to sit for the National 
                Council Licensure EXamination-Registered Nurse 
                (NCLEX-RN); or
                    (B) licensed registered nurses who will 
                receive a graduate or equivalent degree or 
                training to become an advanced education nurse 
                as defined by section 811(b).
            (3) Collegiate school of nursing.--The term 
        ``collegiate school of nursing'' means a department, 
        division, or other administrative unit in a college or 
        university which provides primarily or exclusively a 
        program of education in professional nursing and 
        related subjects leading to the degree of bachelor of 
        arts, bachelor of science, bachelor of nursing, or to 
        an equivalent degree, or to a graduate degree in 
        nursing, or to an equivalent degree, and including 
        advanced training related to such program of education 
        provided by such school, but only if such program, or 
        such unit, college or university is accredited.
            (4) Associate degree school of nursing.--The term 
        ``associate degree school of nursing'' means a 
        department, division, or other administrative unit in a 
        junior college, community college, college, or 
        university which provides primarily or exclusively a 
        two-year program of education in professional nursing 
        and allied subjects leading to an associate degree in 
        nursing or to an equivalent degree, but only if such 
        program, or such unit, college, or university is 
        accredited.
            (5) Diploma school of nursing.--The term ``diploma 
        school of nursing'' means a school affiliated with a 
        hospital or university, or an independent school, which 
        provides primarily or exclusively a program of 
        education in professional nursing and allied subjects 
        leading to a diploma or to equivalent indicia that such 
        program has been satisfactorily completed, but only if 
        such program, or such affiliated school or such 
        hospital or university or such independent school is 
        accredited.
            (6) Accredited.--
                    (A) In general.--Except as provided in 
                subparagraph (B), the term ``accredited'' when 
                applied to any program of nurse education means 
                a program accredited by a recognized body or 
                bodies, or by a State agency, approved for such 
                purpose by the Secretary of Education and when 
                applied to a hospital, school, college, or 
                university (or a unit thereof) means a 
                hospital, school, college, or university (or a 
                unit thereof) which is accredited by a 
                recognized body or bodies, or by a State 
                agency, approved for such purpose by the 
                Secretary of Education. For the purpose of this 
                paragraph, the Secretary of Education shall 
                publish a list of recognized accrediting 
                bodies, and of State agencies, which the 
                Secretary of Education determines to be 
                reliable authority as to the quality of 
                education offered.
                    (B) New programs.--A new program of nursing 
                that, by reason of an insufficient period of 
                operation, is not, at the time of the 
                submission of an application for a grant or 
                contract under this title, eligible for 
                accreditation by such a recognized body or 
                bodies or State agency, shall be deemed 
                accredited for purposes of this title if the 
                Secretary of Education finds, after 
                consultation with the appropriate accreditation 
                body or bodies, that there is reasonable 
                assurance that the program will meet the 
                accreditation standards of such body or bodies 
                prior to the beginning of the academic year 
                following the normal graduation date of 
                students of the first entering class in such a 
                program.
            (7) Nonprofit.--The term ``nonprofit'' as applied 
        to any school, agency, organization, or institution 
        means one which is a corporation or association, or is 
        owned and operated by one or more corporations or 
        associations, no part of the net earnings of which 
        inures, or may lawfully inure, to the benefit of any 
        private shareholder or individual.
            (8) State.--The term ``State'' means a State, the 
        Commonwealth of Puerto Rico, the District of Columbia, 
        the Commonwealth of the Northern Mariana Islands, Guam, 
        American Samoa, the Virgin Islands, or the Trust 
        Territory of the Pacific Islands.
            (9) Ambulatory surgical center.--The term 
        ``ambulatory surgical center'' has the meaning 
        applicable to such term under title XVIII of the Social 
        Security Act.
            (10) Federally qualified health center.--The term 
        ``Federally qualified health center'' has the meaning 
        given such term under section 1861(aa)(4) of the Social 
        Security Act.
            (11) Health care facility.--The term ``health care 
        facility'' means an Indian Health Service health 
        center, a Native Hawaiian health center, a hospital, a 
        Federally qualified health center, a rural health 
        clinic, a nursing home, a home health agency, a hospice 
        program, a public health clinic, a State or local 
        department of public health, a skilled nursing 
        facility, an ambulatory surgical center, or any other 
        facility designated by the Secretary.
            (12) Home health agency.--The term ``home health 
        agency'' has the meaning given such term in section 
        1861(o) of the Social Security Act.
            (13) Hospice program.--The term ``hospice program'' 
        has the meaning given such term in section 1861(dd)(2) 
        of the Social Security Act.
            (14) Rural health clinic.--The term ``rural health 
        clinic'' has the meaning given such term in section 
        1861(aa)(2) of the Social Security Act.
            (15) Skilled nursing facility.--The term ``skilled 
        nursing facility'' has the meaning given such term in 
        section 1819(a) of the Social Security Act.
            (16) Accelerated nursing degree program.--The term 
        ``accelerated nursing degree program'' means a program 
        of education in professional nursing offered by an 
        accredited school of nursing in which an individual 
        holding a bachelors degree in another discipline 
        receives a BSN or MSN degree in an accelerated time 
        frame as determined by the accredited school of 
        nursing.
            (17) Bridge or degree completion program.--The term 
        ``bridge or degree completion program'' means a program 
        of education in professional nursing offered by an 
        accredited school of nursing, as defined in paragraph 
        (2), that leads to a baccalaureate degree in nursing. 
        Such programs may include, Registered Nurse (RN) to 
        Bachelor's of Science of Nursing (BSN) programs, RN to 
        MSN (Master of Science of Nursing) programs, or BSN to 
        Doctoral programs.

SEC. 802. [296A] APPLICATION.

    (a) In General.--To be eligible to receive a grant or 
contract under this title, an eligible entity shall prepare and 
submit to the Secretary an application that meets the 
requirements of this section, at such time, in such manner, and 
containing such information as the Secretary may require.
    (b) Plan.--An application submitted under this section 
shall contain the plan of the applicant for carrying out a 
project with amounts received under this title. Such plan shall 
be consistent with relevant Federal, State, or regional program 
plans.
    (c) Performance Outcome Standards.--An application 
submitted under this section shall contain a specification by 
the applicant entity of performance outcome standards that the 
project to be funded under the grant or contract will be 
measured against. Such standards shall address relevant 
national nursing needs that the project will meet. The 
recipient of a grant or contract under this section shall meet 
the standards set forth in the grant or contract application.
    (d) Linkages.--An application submitted under this section 
shall contain a description of the linkages with relevant 
educational and health care entities, including training 
programs for other health professionals as appropriate, that 
the project to be funded under the grant or contract will 
establish.

SEC. 803. [296B] USE OF FUNDS.

    (a) In General.--Amounts provided under a grant or contract 
awarded under this title may be used for training program 
development and support, faculty development, model 
demonstrations, trainee support including tuition, books, 
program fees and reasonable living expenses during the period 
of training, technical assistance, workforce analysis, and 
dissemination of information, as appropriate to meet recognized 
nursing objectives, in accordance with this title.
    (b) Maintenance of Effort.--With respect to activities for 
which a grant awarded under this title is to be expended, the 
entity shall agree to maintain expenditures of non-Federal 
amounts for such activities at a level that is not less than 
the level of such expenditures maintained by the entity for the 
fiscal year preceding the fiscal year for which the entity 
receives such a grant.

SEC. 804. [296C] MATCHING REQUIREMENT.

    The Secretary may require that an entity that applies for a 
grant or contract under this title provide non-Federal matching 
funds, as appropriate, to ensure the institutional commitment 
of the entity to the projects funded under the grant. Such non-
Federal matching funds may be provided directly or through 
donations from public or private entities and may be in cash or 
in-kind, fairly evaluated, including plant, equipment, or 
services.

SEC. 805. [296D] PREFERENCE.

    In awarding grants or contracts under this title, the 
Secretary shall give preference to applicants with projects 
that will substantially benefit rural or underserved 
populations, or help meet public health nursing needs in State 
or local health departments.

SEC. 806. [296E] GENERALLY APPLICABLE PROVISIONS.

    (a) Awarding of Grants and Contracts.--The Secretary shall 
ensure that grants and contracts under this title are awarded 
on a competitive basis, as appropriate, to carry out innovative 
demonstration projects or provide for strategic workforce 
supplementation activities as needed to meet national nursing 
service goals and in accordance with this title. Contracts may 
be entered into under this title with public or private 
entities as determined necessary by the Secretary.
    (b) Information Requirements.--
            (1) In general.--Recipients of grants and contracts 
        under this title shall meet information requirements as 
        specified by the Secretary.
            (2) Evaluations.--The Secretary shall establish 
        procedures to ensure the annual evaluation of programs 
        and projects operated by recipients of grants under 
        this title. Such procedures shall ensure that continued 
        funding for such programs and projects will be 
        conditioned upon a demonstration that satisfactory 
        progress has been made by the program or project in 
        meeting the objectives of the program or project.
    (c) Training Programs.--Training programs conducted with 
amounts received under this title shall meet applicable 
accreditation and quality standards.
    (d) Duration of Assistance.--
            (1) In general.--Subject to paragraph (2), in the 
        case of an award to an entity of a grant, cooperative 
        agreement, or contract under this title, the period 
        during which payments are made to the entity under the 
        award may not exceed 5 years. The provision of payments 
        under the award shall be subject to annual approval by 
        the Secretary of the payments and subject to the 
        availability of appropriations for the fiscal year 
        involved to make the payments. This paragraph may not 
        be construed as limiting the number of awards under the 
        program involved that may be made to the entity.
            (2) Limitation.--In the case of an award to an 
        entity of a grant, cooperative agreement, or contract 
        under this title, paragraph (1) shall apply only to the 
        extent not inconsistent with any other provision of 
        this title that relates to the period during which 
        payments may be made under the award.
    (e) Peer Review Regarding Certain Programs.--
            (1) In general.--Each application for a grant under 
        this title, except advanced nurse traineeship grants 
        under section 811(a)(2), shall be submitted to a peer 
        review group for an evaluation of the merits of the 
        proposals made in the application. The Secretary may 
        not approve such an application unless a peer review 
        group has recommended the application for approval.
            (2) Composition.--Each peer review group under this 
        subsection shall be composed principally of individuals 
        who are not officers or employees of the Federal 
        Government. In providing for the establishment of peer 
        review groups and procedures, the Secretary shall, 
        except as otherwise provided, ensure sex, racial, 
        ethnic, and geographic representation among the 
        membership of such groups.
            (3) Administration.--This subsection shall be 
        carried out by the Secretary acting through the 
        Administrator of the Health Resources and Services 
        Administration.
    (f) Analytic Activities.--The Secretary shall ensure that--
            (1) cross-cutting workforce analytical activities 
        are carried out as part of the workforce information 
        and analysis activities under this title; and
            (2) discipline-specific workforce information is 
        developed and analytical activities are carried out as 
        part of--
                    (A) the advanced education nursing 
                activities under part B;
                    (B) the workforce diversity activities 
                under part C; and
                    (C) basic nursing education and practice 
                activities under part D.
    (g) State and Regional Priorities.--Activities under grants 
or contracts under this title shall, to the extent practicable, 
be consistent with related Federal, State, or regional nursing 
professions program plans and priorities.
    (h) Filing of Applications.--
            (1) In general.--Applications for grants or 
        contracts under this title may be submitted by health 
        professions schools, schools of nursing, academic 
        health centers, State or local governments, or other 
        appropriate public or private nonprofit entities as 
        determined appropriate by the Secretary in accordance 
        with this title.
            (2) For-profit entities.--Notwithstanding paragraph 
        (1), a for-profit entity may be eligible for a grant or 
        contract under this title as determined appropriate by 
        the Secretary.

SEC. 807. [296E-1] GRANTS FOR HEALTH PROFESSIONS EDUCATION.

    (a) Cultural Competency, Prevention, and Public Health and 
Individuals With Disability Grants.--The Secretary, acting 
through the Administrator of the Health Resources and Services 
Administration, may make awards of grants, contracts, or 
cooperative agreements to eligible entities for the 
development, evaluation, and dissemination of research, 
demonstration projects, and model curricula for cultural 
competency, prevention, public health proficiency, reducing 
health disparities, and aptitude for working with individuals 
with disabilities training for use in health professions 
schools and continuing education programs, and for other 
purposes determined as appropriate by the Secretary. Grants 
under this section shall be the same as provided in section 
741.
    (b) Collaboration.--In carrying out subsection (a), the 
Secretary shall collaborate with the entities described in 
section 741(b). The Secretary shall coordinate with curricula 
and research and demonstration projects developed under such 
section 741.
    (c) Dissemination.--Model curricula developed under this 
section shall be disseminated and evaluated in the same manner 
as model curricula developed under section 741, as described in 
subsection (c) of such section.
    (d) Authorization of Appropriations.--There are to be 
appropriated to carry out this section such sums as may be 
necessary for each of the fiscal years 2010 through 2015.

SEC. 808. [296F] TECHNICAL ASSISTANCE.

    Funds appropriated under this title may be used by the 
Secretary to provide technical assistance in relation to any of 
the authorities under this title.

   prohibition against discrimination by schools on the basis of sex

    Sec. 809. [296g] The Secretary may not make a grant, loan 
guarantee, or interest subsidy payment under this title to, or 
for the benefit of, any school of nursing unless the 
application for the grant, loan guarantee, or interest subsidy 
payment contains assurances satisfactory to the Secretary that 
the school will not discriminate on the basis of sex in the 
admission of individuals to its training programs. The 
Secretary may not enter into a contract under this title with 
any school unless the school furnishes assurances satisfactory 
to the Secretary that it will not discriminate on the basis of 
sex in the admission of individuals to its training programs.

 PART B--NURSE PRACTITIONERS, NURSE MIDWIVES, NURSE ANESTHETISTS, AND 
                    OTHER ADVANCED EDUCATION NURSES

SEC. 811. [296J] ADVANCED EDUCATION NURSING GRANTS.

    (a) In General.--The Secretary may award grants to and 
enter into contracts with eligible entities to meet the costs 
of--
            (1) projects that support the enhancement of 
        advanced nursing education and practice; and
            (2) traineeships for individuals in advanced 
        nursing education programs.
    (b) Definition of Advanced Education Nurses.--For purposes 
of this section, the term ``advanced education nurses'' means 
individuals trained in advanced degree programs including 
individuals in combined R.N./Master's degree programs, post-
nursing master's certificate programs, or, in the case of nurse 
midwives, in certificate programs in existence on the date that 
is one day prior to the date of enactment of this section, to 
serve as nurse practitioners, clinical nurse specialists, nurse 
midwives, nurse anesthetists, nurse educators, nurse 
administrators, or public health nurses, or in other nurse 
specialties determined by the Secretary to require advanced 
education.
    (c) Authorized Nurse Practitioner.--Nurse practitioner 
programs eligible for support under this section are 
educational programs for registered nurses (irrespective of the 
type of school of nursing in which the nurses received their 
training) that--
            (1) meet guidelines prescribed by the Secretary; 
        and
            (2) have as their objective the education of nurses 
        who will upon completion of their studies in such 
        programs, be qualified to effectively provide primary 
        health care, including primary health care in homes and 
        in ambulatory care facilities, long-term care 
        facilities, acute care, and other health care settings.
    (d) Authorized Nurse-midwifery Programs.--Midwifery 
programs that are eligible for support under this section are 
educational programs that--
            (1) have as their objective the education of 
        midwives; and
            (2) are accredited by the American College of 
        Nurse-Midwives Accreditation Commission for Midwifery 
        Education.
    (e) Authorized Nurse Anesthesia Programs.--Nurse anesthesia 
programs eligible for support under this section are education 
programs that--
            (1) provide registered nurses with full-time 
        anesthetist education; and
            (2) are accredited by the Council on Accreditation 
        of Nurse Anesthesia Educational Programs.
    (f) Other Authorized Educational Programs.--The Secretary 
shall prescribe guidelines as appropriate for other advanced 
nurse education programs eligible for support under this 
section.
    (g) Traineeships.--
            (1) In general.--The Secretary may not award a 
        grant to an applicant under subsection (a) unless the 
        applicant involved agrees that traineeships provided 
        with the grant will only pay all or part of the costs 
        of--
                    (A) the tuition, books, and fees of the 
                program of advanced nurse education with 
                respect to which the traineeship is provided; 
                and
                    (B) the reasonable living expenses of the 
                individual during the period for which the 
                traineeship is provided.
            (2) Special consideration.--In making awards of 
        grants and contracts under subsection (a)(2), the 
        Secretary shall give special consideration to an 
        eligible entity that agrees to expend the award to 
        train advanced education nurses who will practice in 
        health professional shortage areas designated under 
        section 332.

             PART C--INCREASING NURSING WORKFORCE DIVERSITY

SEC. 821. [296M] WORKFORCE DIVERSITY GRANTS.

    (a) \1\ In General.--
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    \1\ So in law. There is no paragraph (2) in subsection (a).
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            (1) Authority.--The Secretary may award grants to 
        and enter into contracts with eligible entities to meet 
        the costs of special projects to increase nursing 
        education opportunities for individuals who are from 
        disadvantaged backgrounds (including racial and ethnic 
        minorities underrepresented among registered nurses) by 
        providing student scholarships or stipends, stipends 
        for diploma or associate degree nurses to enter a 
        bridge or degree completion program, student 
        scholarships or stipends for accelerated nursing degree 
        programs, pre-entry preparation, advanced education 
        preparation, and retention activities.
    (b) Guidance.--In carrying out subsection (a), the 
Secretary shall take into consideration the recommendations of 
the National Advisory Council on Nurse Education and Practice 
and consult with nursing associations including the National 
Coalition of Ethnic Minority Nurse Associations, American 
Nurses Association, the National League for Nursing, the 
American Association of Colleges of Nursing, the National Black 
Nurses Association, the National Association of Hispanic 
Nurses, the Association of Asian American and Pacific Islander 
Nurses, the Native American Indian and Alaskan Nurses 
Association, and the National Council of State Boards of 
Nursing, and other organizations determined appropriate by the 
Secretary.
    (c) Required Information and Conditions for Award 
Recipients.--
            (1) In general.--Recipients of awards under this 
        section may be required, where requested, to report to 
        the Secretary concerning the annual admission, 
        retention, and graduation rates for individuals from 
        disadvantaged backgrounds and ethnic and racial 
        minorities in the school or schools involved in the 
        projects.
            (2) Falling rates.--If any of the rates reported 
        under paragraph (1) fall below the average of the two 
        previous years, the grant or contract recipient shall 
        provide the Secretary with plans for immediately 
        improving such rates.
            (3) Ineligibility.--A recipient described in 
        paragraph (2) shall be ineligible for continued funding 
        under this section if the plan of the recipient fails 
        to improve the rates within the 1-year period beginning 
        on the date such plan is implemented.

 PART D--STRENGTHENING CAPACITY FOR BASIC NURSE EDUCATION AND PRACTICE

SEC. 831. [296P] NURSE EDUCATION, PRACTICE, AND QUALITY GRANTS.

    (a) Education Priority Areas.--The Secretary may award 
grants to or enter into contracts with eligible entities for--
            (1) expanding the enrollment in baccalaureate 
        nursing programs; or
            (2) providing education in new technologies, 
        including distance learning methodologies.
    (b) Practice Priority Areas.--The Secretary may award 
grants to or enter into contracts with eligible entities for--
            (1) establishing or expanding nursing practice 
        arrangements in noninstitutional settings to 
        demonstrate methods to improve access to primary health 
        care in medically underserved communities;
            (2) providing care for underserved populations and 
        other high-risk groups such as the elderly, individuals 
        with HIV/AIDS, substance abusers, the homeless, and 
        victims of domestic violence;
            (3) providing coordinated care, and other skills 
        needed to practice in existing and emerging organized 
        health care systems; or
            (4) developing cultural competencies among nurses.
    (c) Retention Priority Areas.--The Secretary may award 
grants to and enter into contracts with eligible entities to 
enhance the nursing workforce by initiating and maintaining 
nurse retention programs pursuant to paragraph (1) or (2).
            (1) Grants for career ladder programs.--The 
        Secretary may award grants to and enter into contracts 
        with eligible entities for programs--
                    (A) to promote career advancement for 
                nursing personnel in a variety of training 
                settings, cross training or specialty training 
                among diverse population groups, and the 
                advancement of individuals including to become 
                professional nurses, advanced education nurses, 
                licensed practical nurses, certified nurse 
                assistants, and home health aides; and
                    (B) to assist individuals in obtaining 
                education and training required to enter the 
                nursing profession and advance within such 
                profession, such as by providing career 
                counseling and mentoring.
            (2) Enhancing patient care delivery systems.--
                    (A) Grants.--The Secretary may award grants 
                to eligible entities to improve the retention 
                of nurses and enhance patient care that is 
                directly related to nursing activities by 
                enhancing collaboration and communication among 
                nurses and other health care professionals, and 
                by promoting nurse involvement in the 
                organizational and clinical decisionmaking 
                processes of a health care facility.
                    (B) Preference.--In making awards of grants 
                under this paragraph, the Secretary shall give 
                a preference to applicants that have not 
                previously received an award under this 
                paragraph.
                    (C) Continuation of an award.--The 
                Secretary shall make continuation of any award 
                under this paragraph beyond the second year of 
                such award contingent on the recipient of such 
                award having demonstrated to the Secretary 
                measurable and substantive improvement in nurse 
                retention or patient care.
    (d) Other Priority Areas.--The Secretary may award grants 
to or enter into contracts with eligible entities to address 
other areas that are of high priority to nurse education, 
practice, and retention, as determined by the Secretary.
    (e) Preference.--For purposes of any amount of funds 
appropriated to carry out this section for fiscal year 2003, 
2004, or 2005 that is in excess of the amount of funds 
appropriated to carry out this section for fiscal year 2002, 
the Secretary shall give preference to awarding grants or 
entering into contracts under subsections (a)(2) and (c).
    (f) Report.--The Secretary shall submit to the Congress 
before the end of each fiscal year a report on the grants 
awarded and the contracts entered into under this section. Each 
such report shall identify the overall number of such grants 
and contracts and provide an explanation of why each such grant 
or contract will meet the priority need of the nursing 
workforce.
    (g) Eligible Entity.--For purposes of this section, the 
term ``eligible entity'' includes a school of nursing, as 
defined in section 801(2),, \1\ a health care facility, or a 
partnership of such a school and facility.
---------------------------------------------------------------------------
    \1\ So in law.
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    (h) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section such sums as may 
be necessary for each of fiscal years 2010 through 2014.

SEC. 831A. [296P-1] NURSE RETENTION GRANTS.

    (a) Retention Priority Areas.--The Secretary may award 
grants to, and enter into contracts with, eligible entities to 
enhance the nursing workforce by initiating and maintaining 
nurse retention programs pursuant to subsection (b) or (c).
    (b) Grants for Career Ladder Program.--The Secretary may 
award grants to, and enter into contracts with, eligible 
entities for programs--
            (1) to promote career advancement for individuals 
        including licensed practical nurses, licensed 
        vocational nurses, certified nurse assistants, home 
        health aides, diploma degree or associate degree 
        nurses, to become baccalaureate prepared registered 
        nurses or advanced education nurses in order to meet 
        the needs of the registered nurse workforce;
            (2) developing and implementing internships and 
        residency programs in collaboration with an accredited 
        school of nursing, as defined by section 801(2), to 
        encourage mentoring and the development of specialties; 
        or
            (3) to assist individuals in obtaining education 
        and training required to enter the nursing profession 
        and advance within such profession.
    (c) Enhancing Patient Care Delivery Systems.--
            (1) Grants.--The Secretary may award grants to 
        eligible entities to improve the retention of nurses 
        and enhance patient care that is directly related to 
        nursing activities by enhancing collaboration and 
        communication among nurses and other health care 
        professionals, and by promoting nurse involvement in 
        the organizational and clinical decision-making 
        processes of a health care facility.
            (2) Priority.--In making awards of grants under 
        this subsection, the Secretary shall give preference to 
        applicants that have not previously received an award 
        under this subsection (or section 831(c) as such 
        section existed on the day before the date of enactment 
        of this section).
            (3) Continuation of an award.--The Secretary shall 
        make continuation of any award under this subsection 
        beyond the second year of such award contingent on the 
        recipient of such award having demonstrated to the 
        Secretary measurable and substantive improvement in 
        nurse retention or patient care.
    (d) Other Priority Areas.--The Secretary may award grants 
to, or enter into contracts with, eligible entities to address 
other areas that are of high priority to nurse retention, as 
determined by the Secretary.
    (e) Report.--The Secretary shall submit to the Congress 
before the end of each fiscal year a report on the grants 
awarded and the contracts entered into under this section. Each 
such report shall identify the overall number of such grants 
and contracts and provide an explanation of why each such grant 
or contract will meet the priority need of the nursing 
workforce.
    (f) Eligible Entity.--For purposes of this section, the 
term ``eligible entity'' includes an accredited school of 
nursing, as defined by section 801(2), a health care facility, 
or a partnership of such a school and facility.
    (g) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section such sums as may 
be necessary for each of fiscal years 2010 through 2012.

                   PART E--STUDENT LOANS 1
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    \1\ Section 936(e) of Public Law 94-63 repealed a section of this 
title that provided for a revolving fund. This former section was 
section 827. With respect to the revolving fund, such section 936(e) 
provided as follows: ``The nurse training fund created within the 
Treasury by section 827(d)(1) of the Act shall remain available to the 
Secretary of Health, Education, and Welfare for the purpose of meeting 
his responsibilities respecting participations in obligations acquired 
under section 827 of the Act. The Secretary shall continue to deposit 
in such fund all amounts received by him as interest payments or 
repayments of principal on loans under such section 827. If at any time 
the Secretary determines the moneys in the funds exceed the present and 
any reasonable prospective further requirements of such fund, such 
excess may be transferred to the general fund of the Treasury.''. Such 
section further provided that ``[t]here are authorized to be 
appropriated without fiscal year limitation such sums as may be 
necessary to enable the Secretary to make payments under agreements 
entered into under section 827(b) of the Act before [July 27, 1975]''.
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                            loan agreements

    Sec. 835. [297a] (a) The Secretary is authorized to enter 
into an agreement for the establishment and operation of a 
student loan fund in accordance with this part with any public 
or nonprofit private school of nursing which is located in a 
State.
    (b) Each agreement entered into under this section shall--
            (1) provide for establishment of a student loan 
        fund by the school;
            (2) provide for deposit in the fund, except as 
        provided in section 871, of (A) the Federal capital 
        contributions paid from allotments under section 838 to 
        the school by the Secretary, (B) an additional amount 
        from other sources equal to not less than one-ninth of 
        such Federal capital contributions, (C) collections of 
        principal and interest on loans made from the fund, (D) 
        collections pursuant to section 836(f), and (E) any 
        other earnings of the fund;
            (3) provide that the fund, except as provided in 
        section 871, shall be used only for loans to students 
        of the school in accordance with the agreement and for 
        costs of collection of such loans and interest thereon;
            (4) provide that loans may be made from such fund 
        only to students pursuing a full-time or half-time 
        course of study at the school leading to a 
        baccalaureate or associate degree in nursing or an 
        equivalent degree or a diploma in nursing, or to a 
        graduate degree in nursing; and
            (5) contain such other provisions as are necessary 
        to protect the financial interests of the United 
        States.
      (c)(1) Any standard established by the Secretary by 
regulation for the collection by schools of nursing of loans 
made pursuant to loan agreements under this part shall provide 
that the failure of any such school to collect such loans shall 
be measured in accordance with this subsection. With respect to 
the student loan fund established pursuant to such agreements, 
this subsection may not be construed to require such schools to 
reimburse such loan fund for loans that became uncollectable 
prior to 1983.
      (2) The measurement of a school's failure to collect 
loans made under this part shall be the ratio (stated as a 
percentage) that the defaulted principal amount outstanding of 
such school bears to the matured loans of such school.
      (3) For purposes of this subsection--
            (A) the term ``default'' means the failure of a 
        borrower of a loan made under this part to--
                    (i) make an installment payment when due; 
                or
                    (ii) comply with any other term of the 
                promissory note for such loan,
        except that a loan made under this part shall not be 
        considered to be in default if the loan is discharged 
        in bankruptcy or if the school reasonably concludes 
        from written contacts with the borrower that the 
        borrower intends to repay the loan;
            (B) the term ``defaulted principal amount 
        outstanding'' means the total amount borrowed from the 
        loan fund of a school that has reached the repayment 
        stage (minus any principal amount repaid or cancelled) 
        on loans--
                    (i) repayable monthly and in default for at 
                least 120 days; and
                    (ii) repayable less frequently than monthly 
                and in default for at least 180 days;
            (C) the term ``grace period'' means the period of 
        nine months beginning on the date on which the borrower 
        ceases to pursue a full-time or half-time course of 
        study at a school of nursing; and
            (D) the term ``matured loans'' means the total 
        principal amount of all loans made by a school of 
        nursing under this part minus the total principal 
        amount of loans made by such school to students who 
        are--
                    (i) enrolled in a full-time or half-time 
                course of study at such school; or
                    (ii) in their grace period.

                            loan provisions

    Sec. 836. [297b] (a) The total of the loans for any 
academic year (or its equivalent, as determined under 
regulations of the Secretary) made by schools of nursing from 
loan funds established pursuant to agreements under this part 
may not exceed $3,300 in the case of any student, except that 
for the final two academic years of the program involved, such 
total may not exceed $5,200. The aggregate of the loans for all 
years from such funds may not exceed $17,000 in the case of any 
student during fiscal years 2010 and 2011. After fiscal year 
2011, such amounts shall be adjusted to provide for a cost-of-
attendance increase for the yearly loan rate and the aggregate 
of the loans.
    (b) Loans from any such student loan fund by any school 
shall be made on such terms and conditions as the school may 
determine; subject, however, to such conditions, limitations, 
and requirements as the Secretary may prescribe (by regulation 
or in the agreement with the school) with a view to preventing 
impairment of the capital of such fund to the maximum extent 
practicable in the light of the objective of enabling the 
student to complete his course of study; and except that--
            (1) such a loan may be made only to a student who 
        (A) is in need of the amount of the loan to pursue a 
        full-time or half-time course of study at the school 
        leading to a baccalaureate or associate degree in 
        nursing or an equivalent degree, or a diploma in 
        nursing, or a graduate degree in nursing, (B) is 
        capable, in the opinion of the school, of maintaining 
        good standing in such course of study, and (C) with 
        respect to any student enrolling in the school after 
        June 30, 2000, is of financial need (as defined in 
        regulations issued by the Secretary);
            (2) such a loan shall be repayable in equal or 
        graduated periodic installments (with the right of the 
        borrower to accelerate repayment) over the ten-year 
        period which begins nine months after the student 
        ceases to pursue a full-time or half-time course of 
        study at a school of nursing, excluding from such 10-
        year period all (A) periods (up to three years) of (i) 
        active duty performed by the borrower as a member of a 
        uniformed service, or (ii) service as a volunteer under 
        the Peace Corps Act, (B) periods (up to ten years) 
        during which the borrower is pursuing a full-time or 
        half-time course of study at a collegiate school of 
        nursing leading to baccalaureate degree in nursing or 
        an equivalent degree, or to graduate degree in nursing, 
        or is otherwise pursuing advanced professional training 
        in nursing (or training to be a nurse anesthetist), and 
        (C) such additional periods under the terms of 
        paragraph (8) of this subsection;
            (3) in the case of a student who received such a 
        loan before September 29, 1995, an amount up to 85 per 
        centum of any such loan made before such date (plus 
        interest thereon) shall be canceled for full-time 
        employment as a professional nurse (including teaching 
        in any of the fields of nurse training and service as 
        an administrator, supervisor, or consultant in any of 
        the fields of nursing) in any public or nonprofit 
        private agency, institution, or organization (including 
        neighborhood health centers), at the rate of 15 per 
        centum of the amount of such loan (plus interest) 
        unpaid on the first day of such service for each of the 
        first, second, and third complete year of such service, 
        and 20 per centum of such amount (plus interest) for 
        each complete fourth and fifth year of such service;
            (4) the liability to repay the unpaid balance of 
        such loan and accrued interest thereon shall be 
        canceled upon the death of the borrower, or if the 
        Secretary determines that he has become permanently and 
        totally disabled;
            (5) such a loan shall bear interest on the unpaid 
        balance of the loan, computed only for periods during 
        which the loan is repayable, at the rate of 5 percent 
        per annum;
            (6) such a loan shall be made without security or 
        endorsement, except that if the borrower is a minor and 
        the note or other evidence of obligation executed by 
        him would not, under the applicable law, create a 
        binding obligation, either security or endorsement may 
        be required;
            (7) no note or other evidence of any such loan may 
        be transferred or assigned by the school making the 
        loan except that, if the borrower transfers to another 
        school participating in the program under this part, 
        such note or other evidence of a loan may be 
        transferred to such other school; and
            (8) pursuant to uniform criteria established by the 
        Secretary, the repayment period established under 
        paragraph (2) for any student borrower who during the 
        repayment period failed to make consecutive payments 
        and who, during the last 12 months of the repayment 
        period, has made at least 12 consecutive payments may 
        be extended for a period not to exceed 10 years.
    (c) Where all or any part of a loan, or interest, is 
canceled under this section, the Secretary shall pay to the 
school an amount equal to the school's proportionate share of 
the canceled portion, as determined by the Secretary.
    (d) Any loan for any year by a school from a student loan 
fund established pursuant to an agreement under this part shall 
be made in such installments as may be provided in regulations 
of the Secretary or such agreement and, upon notice to the 
Secretary by the school that any recipient of a loan is failing 
to maintain satisfactory standing, any or all further 
installments of his loans shall be withheld, as may be 
appropriate.
    (e) An agreement under this part with any school shall 
include provisions designed to make loans from the student loan 
fund established thereunder reasonably available (to the extent 
of the available funds in such fund) to all eligible students 
in the school in need thereof.
    (f) Subject to regulations of the Secretary and in 
accordance with this section, a school shall assess a charge 
with respect to a loan from the loan fund established pursuant 
to an agreement under this part for failure of the borrower to 
pay all or any part of an installment when it is due and, in 
the case of a borrower who is entitled to deferment of the loan 
under subsection (b)(2) or cancellation of part or all of the 
loan under subsection (b)(3), for any failure to file timely 
and satisfactory evidence of such entitlement. No such charge 
may be made if the payment of such installment or the filing of 
such evidence is made within 60 days after the date on which 
such installment or filing is due. The amount of any such 
charge may not exceed an amount equal to 6 percent of the 
amount of such installment. The school may elect to add the 
amount of any such charge to the principal amount of the loan 
as of the first day after the day on which such installment or 
evidence was due, or to make the amount of the charge payable 
to the school not later than the due date of the next 
installment after receipt by the borrower of notice of the 
assessment of the charge.
    (g) A school may provide in accordance with regulations of 
the Secretary, that during the repayment period of a loan from 
a loan fund established pursuant to an agreement under this 
part payments of principal and interest by the borrower with 
respect to all the outstanding loans made to him from loan 
funds so established shall be at a rate equal to not less than 
$40 per month.
    (h) Notwithstanding the amendment made by section 6(b) of 
the Nurse Training Act of 1971 to this section--
            (A) any person who obtained one or more loans from 
        a loan fund established under this part, who before the 
        date of the enactment of the Nurse Training Act of 1971 
        became eligible for cancellation of all or part of such 
        loans (including accrued interest) under this section 
        (as in effect on the day before such date), and who on 
        such date was not engaged in a service for which loan 
        cancellation was authorized under this section (as so 
        in effect), may at any time elect to receive such 
        cancellation in accordance with this subsection (as so 
        in effect); and
            (B) in the case of any person who obtained one or 
        more loans from a loan fund established under this part 
        and who on such date was engaged in a service for which 
        cancellation of all or part of such loans (including 
        accrued interest) was authorized under this section (as 
        so in effect), this section (as so in effect) shall 
        continue to apply to such person for purposes of 
        providing such loan cancellation until he terminates 
        such service.
    (i) Upon application by a person who received and is under 
an obligation to repay, any loan made to such person as a 
nursing student, the Secretary may undertake to repay (without 
liability to the applicant) all or any part of such loan, and 
any interest or portion thereof outstanding thereon, upon his 
determination, pursuant to regulations establishing criteria 
therefor, that the applicant--
            (1) failed to complete the nursing studies with 
        respect to which such loan was made;
            (2) is in exceptionally needy circumstances; and
            (3) has not resumed, or cannot reasonably be 
        expected to resume, such nursing studies within two 
        years following the date upon which the applicant 
        terminated the studies with respect to which such loan 
        was made.
      (j) The Secretary is authorized to attempt to collect any 
loan which was made under this part, which is in default, and 
which was referred to the Secretary by a school of nursing with 
which the Secretary has an agreement under this part, on behalf 
of that school under such terms and conditions as the Secretary 
may prescribe (including reimbursement from the school's 
student loan fund for expenses the Secretary may reasonably 
incur in attempting collection), but only if the school has 
complied with such requirements as the Secretary may specify by 
regulation with respect to the collection of loans under this 
part. A loan so referred shall be treated as a debt subject to 
section 5514 of title 5, United States Code. Amounts collected 
shall be deposited in the school's student loan fund. Whenever 
the Secretary desires the institution of a civil action 
regarding any such loan, the Secretary shall refer the matter 
to the Attorney General for appropriate action.
    (k) \3\ Elimination of Statute of Limitation for Loan 
Collections.--
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    \3\ Paragraph (2) of section 133(c) of Public Law 105-392 provides 
as follows: ``The amendment made by paragraph (1) shall be effective 
with respect to actions pending on or after the date of enactment of 
this Act.''.
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            (1) Purpose.--It is the purpose of this subsection 
        to ensure that obligations to repay loans under this 
        section are enforced without regard to any Federal or 
        State statutory, regulatory, or administrative 
        limitation on the period within which debts may be 
        enforced.
            (2) Prohibition.--Notwithstanding any other 
        provision of Federal or State law, no limitation shall 
        terminate the period within which suit may be filed, a 
        judgment may be enforced, or an offset, garnishment, or 
        other action may be initiated or taken by a school of 
        nursing that has an agreement with the Secretary 
        pursuant to section 835 that is seeking the repayment 
        of the amount due from a borrower on a loan made under 
        this part after the default of the borrower on such 
        loan.

        allotments and payments of federal capital contributions

    Sec. 838. \2\ [297d] (a)(1) The Secretary shall from time 
to time set dates by which schools of nursing in a State must 
file applications for Federal capital contributions.
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    \2\ Section 837 was repealed by section 123(3) of Public Law 105-
392 (112 Stat. 3562).
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    (2)(A) If the total of the amounts requested for any fiscal 
year in such applications exceeds the total amount appropriated 
under section 837 \2\ for that fiscal year, the allotment from 
such total amount to the loan fund of each school of nursing 
shall be reduced to whichever of the following is the smaller:
            (i) The amount requested in its application.
            (ii) An amount which bears the same ratio to the 
        total amount appropriated as the number of students 
        estimated by the Secretary to be enrolled on a full-
        time basis in such school during such fiscal year bears 
        to the estimated total number of students enrolled in 
        all such schools on a full-time basis during such year.
      (B) Amounts remaining after allotment under subparagraph 
(A) shall be reallotted in accordance with clause (ii) of such 
subparagraph among schools whose applications requested more 
than the amounts so allotted to their loan funds, but with such 
adjustments as may be necessary to prevent the total allotted 
to any such school's loan fund under this paragraph and 
paragraph (3) from exceeding the total so requested by it.
      (3) Funds which, pursuant to section 839(c) or pursuant 
to a loan agreement under section 835, are returned to the 
Secretary in any fiscal year, shall be available for allotment 
until expended. Funds described in the preceding sentence shall 
be allotted among schools of nursing in such manner as the 
Secretary determines will best carry out this part.
      (b) Allotments to a loan fund of a school shall be paid 
to it from time to time in such installments as the Secretary 
determines will not result in unnecessary accumulations in the 
loan fund at such school.
    (c) The Federal capital contributions to a loan fund of a 
school under this part shall be paid to it from time to time in 
such installments as the Secretary determines will not result 
in unnecessary accumulations in the loan fund at such school.

                 distribution of assets from loan funds

    Sec. 839. [297e] (a) If a school terminates a loan fund 
established under an agreement pursuant to section 835(b), or 
if the Secretary for good cause terminates the agreement with 
the school, there shall be a capital distribution as follows:
            (1) The Secretary shall first be paid an amount 
        which bears the same ratio to such balance in such fund 
        on the date of termination of the fund as the total 
        amount of the Federal capital contributions to such 
        fund by the Secretary pursuant to section 835(b)(2)(A) 
        bears to the total amount in such fund derived from 
        such Federal capital contributions and from funds 
        deposited therein pursuant to section 835(b)(2)(B).
            (2) The remainder of such balance shall be paid to 
        the school.
    (b) If a capital distribution is made under subsection (a), 
the school involved shall, after such capital distribution, pay 
to the Secretary, not less often than quarterly, the same 
proportionate share of amounts received by the school in 
payment of principal or interest on loans made from the loan 
fund established under section 835(b) as determined by the 
Secretary under subsection (a).
      (c)(1) Within 90 days after the termination of any 
agreement with a school under section 835 or the termination in 
any other manner of a school's participation in the loan 
program under this subpart \1\, such school shall pay to the 
Secretary from the balance of the loan fund of such school 
established under section 835, an amount which bears the same 
ratio to the balance in such fund on the date of such 
termination as the total amount of the Federal capital 
contributions to such fund by the Secretary pursuant to section 
835(b)(2)(A) bears to the total amount in such fund on such 
date derived from such Federal capital contributions and from 
funds deposited in the fund pursuant to section 835(b)(2)(B). 
The remainder of such balance shall be paid to the school.
---------------------------------------------------------------------------
    \1\ So in law. Probably should read ``part''.
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      (2) A school to which paragraph (1) applies shall pay to 
the Secretary after the date on which payment is made under 
such paragraph and not less than quarterly, the same 
proportionate share of amounts received by the school after the 
date of termination referred to in paragraph (1) in payment of 
principal or interest on loans made from the loan fund as was 
determined for the Secretary under such 
paragraph.These sections appeared in subpart II of 
Part B. Do they stay? If so the sequence of sections are not 
right. deg.

                       administrative provisions

    Sec. 840. [297g] The Secretary may agree to modifications 
of agreements made under this part, and may compromise, waive, 
or release any right, title, claim, or demand of the United 
States arising or acquired under this part.

                 procedures for appeal of terminations

      Sec. 842. \2\  [297i] In any case in which the Secretary 
intends to terminate an agreement with a school of nursing 
under this part, the Secretary shall provide the school with a 
written notice specifying such intention and stating that the 
school may request a formal hearing with respect to such 
termination. If the school requests such a hearing within 30 
days after the receipt of such notice, the Secretary shall 
provide such school with a hearing conducted by an 
administrative law judge.
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    \2\ There is no section 841 between sections 840 and 842. Section 
5310(b)(7) of Public Law 111-148 redesignates section 841 as section 
871. Such amendment also redesignates part F as part I and transfers 
part I (as redesignated) to the end of this title.
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                loan repayment and scholarship programs
    Sec. 846. \1\  [297n] (a) In General.--In the case of any 
individual--
---------------------------------------------------------------------------
    \1\ Title VIII does not contain a section 843 or 844. A section 845 
appears in part G on page 810.
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            (1) who has received a baccalaureate or associate 
        degree in nursing (or an equivalent degree), a diploma 
        in nursing, or a graduate degree in nursing;
            (2) who obtained (A) one or more loans from a loan 
        fund established under subpart II \2\, or (B) any other 
        educational loan for nurse training costs; and
---------------------------------------------------------------------------
    \2\ So in law. Probably should read ``part''.
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            (3) who enters into an agreement with the Secretary 
        to serve as nurse for a period of not less than two 
        years at a health care facility with a critical 
        shortage of nurses, or in a accredited school of 
        nursing, as defined by section 801(2), as nurse 
        faculty;
the Secretary shall make payments in accordance with subsection 
(b), for and on behalf of that individual, on the principal of 
and interest on any loan of that individual described in 
paragraph (2) of this subsection which is outstanding on the 
date the individual begins the service specified in the 
agreement described in paragraph (3) of this subsection. After 
fiscal year 2007, the Secretary may not, pursuant to any 
agreement entered into under this subsection, assign a nurse to 
any private entity unless that entity is nonprofit.
    (b) Manner of Payments.--The payments described in 
subsection (a) shall be made by the Secretary as follows:
            (1) Upon completion by the individual for whom the 
        payments are to be made of the first year of the 
        service specified in the agreement entered into with 
        the Secretary under subsection (a), the Secretary shall 
        pay 30 percent of the principal of, and the interest on 
        each loan of such individual described in subsection 
        (a)(2) which is outstanding on the date he began such 
        practice.
            (2) Upon completion by that individual of the 
        second year of such service, the Secretary shall pay 
        another 30 percent of the principal of, and the 
        interest on each such loan.
            (3) Upon completion by that individual of a third 
        year of such service, the Secretary shall pay another 
        25 percent of the principal of, and the interest on 
        each such loan.
    (c) Payment by Due Date.--Notwithstanding the requirement 
of completion of practice specified in subsection (b), the 
Secretary shall, on or before the due date thereof, pay any 
loan or loan installment which may fall due within the period 
of service for which the borrower may receive payments under 
this subsection, upon the declaration of such borrower, at such 
times and in such manner as the Secretary may prescribe (and 
supported by such other evidence as the Secretary may 
reasonably require), that the borrower is then serving as 
described by subsection (a)(3), and that the borrower will 
continue to so serve for the period required (in the absence of 
this subsection) to entitle the borrower to have made the 
payments provided by this subsection for such period; except 
that not more than 85 percent of the principal of any such loan 
shall be paid pursuant to this subsection.
    (d) Scholarship Program.--
            (1) In general.--The Secretary shall (for fiscal 
        years 2003 and 2004) and may (for fiscal years 
        thereafter) carry out a program of entering into 
        contracts with eligible individuals under which such 
        individuals agree to serve as nurses for a period of 
        not less than 2 years at a health care facility with a 
        critical shortage of nurses, in consideration of the 
        Federal Government agreeing to provide to the 
        individuals scholarships for attendance at schools of 
        nursing.
            (2) Eligible individuals.--In this subsection, the 
        term ``eligible individual'' means an individual who is 
        enrolled or accepted for enrollment as a full-time or 
        part-time student in a school of nursing.
            (3) Service requirement.--
                    (A) In general.--The Secretary may not 
                enter into a contract with an eligible 
                individual under this subsection unless the 
                individual agrees to serve as a nurse at a 
                health care facility with a critical shortage 
                of nurses for a period of full-time service of 
                not less than 2 years, or for a period of part-
                time service in accordance with subparagraph 
                (B).
                    (B) Part-time service.--An individual may 
                complete the period of service described in 
                subparagraph (A) on a part-time basis if the 
                individual has a written agreement that--
                            (i) is entered into by the facility 
                        and the individual and is approved by 
                        the Secretary; and
                            (ii) provides that the period of 
                        obligated service will be extended so 
                        that the aggregate amount of service 
                        performed will equal the amount of 
                        service that would be performed through 
                        a period of full-time service of not 
                        less than 2 years.
            (4) Applicability of certain provisions.--The 
        provisions of subpart III of part D of title III shall, 
        except as inconsistent with this section, apply to the 
        program established in paragraph (1) in the same manner 
        and to the same extent as such provisions apply to the 
        National Health Service Corps Scholarship Program 
        established in such subpart.
    (e) Preferences Regarding Participants.--In entering into 
agreements under subsection (a) or (d), the Secretary shall 
give preference to qualified applicants with the greatest 
financial need.
    (f) Breach of Agreement.--The Secretary may make payments 
under subsection (a) on behalf of an individual only if the 
agreement under such subsection provides that section 860(c) is 
applicable to the individual.
    (g) Breach of Agreement.--
            (1) In general.--In the case of any program under 
        this section under which an individual makes an 
        agreement to provide health services for a period of 
        time in accordance with such program in consideration 
        of receiving an award of Federal funds regarding 
        education as a nurse (including an award for the 
        repayment of loans), the following applies if the 
        agreement provides that this subsection is applicable:
                    (A) In the case of a program under this 
                section that makes an award of Federal funds 
                for attending an accredited program of nursing 
                (in this section referred to as a ``nursing 
                program''), the individual is liable to the 
                Federal Government for the amount of such award 
                (including amounts provided for expenses 
                related to such attendance), and for interest 
                on such amount at the maximum legal prevailing 
                rate, if the individual--
                            (i) fails to maintain an acceptable 
                        level of academic standing in the 
                        nursing program (as indicated by the 
                        program in accordance with requirements 
                        established by the Secretary);
                            (ii) is dismissed from the nursing 
                        program for disciplinary reasons; or
                            (iii) voluntarily terminates the 
                        nursing program.
                    (B) The individual is liable to the Federal 
                Government for the amount of such award 
                (including amounts provided for expenses 
                related to such attendance), and for interest 
                on such amount at the maximum legal prevailing 
                rate, if the individual fails to provide health 
                services in accordance with the program under 
                this section for the period of time applicable 
                under the program.
            (2) Waiver or suspension of liability.--In the case 
        of an individual or health facility making an agreement 
        for purposes of paragraph (1), the Secretary shall 
        provide for the waiver or suspension of liability under 
        such subsection if compliance by the individual or the 
        health facility, as the case may be, with the 
        agreements involved is impossible, or would involve 
        extreme hardship to the individual or facility, and if 
        enforcement of the agreements with respect to the 
        individual or facility would be unconscionable.
            (3) Date certain for recovery.--Subject to 
        paragraph (2), any amount that the Federal Government 
        is entitled to recover under paragraph (1) shall be 
        paid to the United States not later than the expiration 
        of the 3-year period beginning on the date the United 
        States becomes so entitled.
            (4) Availability.--Amounts recovered under 
        paragraph (1) with respect to a program under this 
        section shall be available for the purposes of such 
        program, and shall remain available for such purposes 
        until expended.
    (h) Reports.--Not later than 18 months after the date of 
enactment of the Nurse Reinvestment Act, and annually 
thereafter, the Secretary shall prepare and submit to the 
Congress a report describing the programs carried out under 
this section, including statements regarding--
            (1) the number of enrollees, scholarships, loan 
        repayments, and grant recipients;
            (2) the number of graduates;
            (3) the amount of scholarship payments and loan 
        repayments made;
            (4) which educational institution the recipients 
        attended;
            (5) the number and placement location of the 
        scholarship and loan repayment recipients at health 
        care facilities with a critical shortage of nurses;
            (6) the default rate and actions required;
            (7) the amount of outstanding default funds of both 
        the scholarship and loan repayment programs;
            (8) to the extent that it can be determined, the 
        reason for the default;
            (9) the demographics of the individuals 
        participating in the scholarship and loan repayment 
        programs;
            (10) justification for the allocation of funds 
        between the scholarship and loan repayment programs; 
        and
            (11) an evaluation of the overall costs and 
        benefits of the programs.
    (i) Funding.--
            (1) Authorization of appropriations.--For the 
        purpose of payments under agreements entered into under 
        subsection (a) or (d), there are authorized to be 
        appropriated such sums as may be necessary for each of 
        fiscal years 2003 through 2007.
            (2) Allocations.--Of the amounts appropriated under 
        paragraph (1), the Secretary may, as determined 
        appropriate by the Secretary, allocate amounts between 
        the program under subsection (a) and the program under 
        subsection (d).

                       nurse faculty loan program

    Sec. 846A. [297n-1] (a) School of Nursing Student Loan 
Fund.--The Secretary, acting through the Administrator of the 
Health Resources and Services Administration, may enter into an 
agreement with any accredited school of nursing for the 
establishment and operation of a student loan fund in 
accordance with this section, to increase the number of 
qualified nursing faculty.
    (b) Agreements.--Each agreement entered into under 
subsection (a) shall--
            (1) provide for the establishment of a student loan 
        fund by the school involved;
            (2) provide for deposit in the fund of--
                    (A) the Federal capital contributions to 
                the fund;
                    (B) an amount equal to not less than one-
                ninth of such Federal capital contributions, 
                contributed by such school;
                    (C) collections of principal and interest 
                on loans made from the fund; and
                    (D) any other earnings of the fund;
            (3) provide that the fund will be used only for 
        loans to students of the school in accordance with 
        subsection (c) and for costs of collection of such 
        loans and interest thereon;
            (4) provide that loans may be made from such fund 
        only to students pursuing a full-time course of study 
        or, at the discretion of the Secretary, a part-time 
        course of study in an advanced degree program described 
        in section 811(b); and
            (5) contain such other provisions as are necessary 
        to protect the financial interests of the United 
        States.
    (c) Loan Provisions.--Loans from any student loan fund 
established by a school pursuant to an agreement under 
subsection (a) shall be made to an individual on such terms and 
conditions as the school may determine, except that--
            (1) such terms and conditions are subject to any 
        conditions, limitations, and requirements prescribed by 
        the Secretary;
            (2) in the case of any individual, the total of the 
        loans for any academic year made by schools of nursing 
        from loan funds established pursuant to agreements 
        under subsection (a) may not exceed $35,500, during 
        fiscal years 2010 and 2011 fiscal years (after fiscal 
        year 2011, such amounts shall be adjusted to provide 
        for a cost-of-attendance increase for the yearly loan 
        rate and the aggregate loan;
            (3) an amount up to 85 percent of any such loan 
        (plus interest thereon) shall be canceled by the school 
        as follows:
                    (A) upon completion by the individual of 
                each of the first, second, and third year of 
                full-time employment, required by the loan 
                agreement entered into under this subsection, 
                as a faculty member in an accredited a \1\ 
                school of nursing, the school shall cancel 20 
                percent of the principle of, and the interest 
                on, the amount of such loan unpaid on the first 
                day of such employment; and
---------------------------------------------------------------------------
    \1\ So in law. Probably should read ``...as a faculty member in an 
accredited school of nursing...''.
---------------------------------------------------------------------------
                    (B) upon completion by the individual of 
                the fourth year of full-time employment, 
                required by the loan agreement entered into 
                under this subsection, as a faculty member in a 
                school of nursing, the school shall cancel 25 
                percent of the principle of, and the interest 
                on, the amount of such loan unpaid on the first 
                day of such employment;
            (4) such a loan may be used to pay the cost of 
        tuition, fees, books, laboratory expenses, and other 
        reasonable education expenses;
            (5) such a loan shall be repayable in equal or 
        graduated periodic installments (with the right of the 
        borrower to accelerate repayment) over the 10-year 
        period that begins 9 months after the individual ceases 
        to pursue a course of study at a school of nursing; and
            (6) such a loan shall--
                    (A) beginning on the date that is 3 months 
                after the individual ceases to pursue a course 
                of study at a school of nursing, bear interest 
                on the unpaid balance of the loan at the rate 
                of 3 percent per annum; or
                    (B) subject to subsection (e), if the 
                school of nursing determines that the 
                individual will not complete such course of 
                study or serve as a faculty member as required 
                under the loan agreement under this subsection, 
                bear interest on the unpaid balance of the loan 
                at the prevailing market rate.
    (d) Payment of Proportionate Share.--Where all or any part 
of a loan, or interest, is canceled under this section, the 
Secretary shall pay to the school an amount equal to the 
school's proportionate share of the canceled portion, as 
determined by the Secretary.
    (e) Review by Secretary.--At the request of the individual 
involved, the Secretary may review any determination by an 
accredited school of nursing under subsection (c)(6)(B).
    (f) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section such sums as may 
be necessary for each of fiscal years 2010 through 2014.

SEC. 847. [297O] ELIGIBLE INDIVIDUAL STUDENT LOAN REPAYMENT.

    (a) In General.--The Secretary, acting through the 
Administrator of the Health Resources and Services 
Administration, may enter into an agreement with eligible 
individuals for the repayment of education loans, in accordance 
with this section, to increase the number of qualified nursing 
faculty.
    (b) Agreements.--Each agreement entered into under this 
subsection shall require that the eligible individual shall 
serve as a full-time member of the faculty of an accredited 
school of nursing, for a total period, in the aggregate, of at 
least 4 years during the 6-year period beginning on the later 
of--
            (1) the date on which the individual receives a 
        master's or doctorate nursing degree from an accredited 
        school of nursing; or
            (2) the date on which the individual enters into an 
        agreement under this subsection.
    (c) Agreement Provisions.--Agreements entered into pursuant 
to subsection (b) shall be entered into on such terms and 
conditions as the Secretary may determine, except that--
            (1) not more than 10 months after the date on which 
        the 6-year period described under subsection (b) 
        begins, but in no case before the individual starts as 
        a full-time member of the faculty of an accredited 
        school of nursing the Secretary shall begin making 
        payments, for and on behalf of that individual, on the 
        outstanding principal of, and interest on, any loan of 
        that individual obtained to pay for such degree;
            (2) for an individual who has completed a master's 
        in nursing or equivalent degree in nursing--
                    (A) payments may not exceed $10,000 per 
                calendar year; and
                    (B) total payments may not exceed $40,000 
                during the 2010 and 2011 fiscal years (after 
                fiscal year 2011, such amounts shall be 
                adjusted to provide for a cost-of-attendance 
                increase for the yearly loan rate and the 
                aggregate loan); and
            (3) for an individual who has completed a doctorate 
        or equivalent degree in nursing--
                    (A) payments may not exceed $20,000 per 
                calendar year; and
                    (B) total payments may not exceed $80,000 
                during the 2010 and 2011 fiscal years (adjusted 
                for subsequent fiscal years as provided for in 
                the same manner as in paragraph (2)(B)).
    (d) Breach of Agreement.--
            (1) In general.--In the case of any agreement made 
        under subsection (b), the individual is liable to the 
        Federal Government for the total amount paid by the 
        Secretary under such agreement, and for interest on 
        such amount at the maximum legal prevailing rate, if 
        the individual fails to meet the agreement terms 
        required under such subsection.
            (2) Waiver or suspension of liability.--In the case 
        of an individual making an agreement for purposes of 
        paragraph (1), the Secretary shall provide for the 
        waiver or suspension of liability under such paragraph 
        if compliance by the individual with the agreement 
        involved is impossible or would involve extreme 
        hardship to the individual or if enforcement of the 
        agreement with respect to the individual would be 
        unconscionable.
            (3) Date certain for recovery.--Subject to 
        paragraph (2), any amount that the Federal Government 
        is entitled to recover under paragraph (1) shall be 
        paid to the United States not later than the expiration 
        of the 3-year period beginning on the date the United 
        States becomes so entitled.
            (4) Availability.--Amounts recovered under 
        paragraph (1) shall be available to the Secretary for 
        making loan repayments under this section and shall 
        remain available for such purpose until expended.
    (e) Eligible Individual Defined.--For purposes of this 
section, the term ``eligible individual'' means an individual 
who--
            (1) is a United States citizen, national, or lawful 
        permanent resident;
            (2) holds an unencumbered license as a registered 
        nurse; and
            (3) has either already completed a master's or 
        doctorate nursing program at an accredited school of 
        nursing or is currently enrolled on a full-time or 
        part-time basis in such a program.
    (f) Priority.--For the purposes of this section and section 
846A, funding priority will be awarded to School of Nursing 
Student Loans that support doctoral nursing students or 
Individual Student Loan Repayment that support doctoral nursing 
students.
    (g) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section such sums as may 
be necessary for each of fiscal years 2010 through 2014.

   PART F--NATIONAL ADVISORY COUNCIL ON NURSE EDUCATION AND PRACTICE

SEC. 851. [297T] NATIONAL ADVISORY COUNCIL ON NURSE EDUCATION AND 
                    PRACTICE.

    (a) Establishment.--The Secretary shall establish an 
advisory council to be known as the National Advisory Council 
on Nurse Education and Practice (in this section referred to as 
the ``Advisory Council'').
    (b) Composition.--
            (1) In general.--The Advisory Council shall be 
        composed of--
                    (A) not less than 21, nor more than 23 
                individuals, who are not officers or employees 
                of the Federal Government, appointed by the 
                Secretary without regard to the Federal civil 
                service laws, of which--
                            (i) 2 shall be selected from full-
                        time students enrolled in schools of 
                        nursing;
                            (ii) 2 shall be selected from the 
                        general public;
                            (iii) 2 shall be selected from 
                        practicing professional nurses; and
                            (iv) 9 shall be selected from among 
                        the leading authorities in the various 
                        fields of nursing, higher, secondary 
                        education, and associate degree schools 
                        of nursing, and from representatives of 
                        advanced education nursing groups (such 
                        as nurse practitioners, nurse midwives, 
                        and nurse anesthetists), hospitals, and 
                        other institutions and organizations 
                        which provide nursing services; and
                    (B) the Secretary (or the delegate of the 
                Secretary (who shall be an ex officio member 
                and shall serve as the Chairperson)).
            (2) Appointment.--Not later than 90 days after the 
        date of enactment of this Act \1\, the Secretary shall 
        appoint the members of the Advisory Council and each 
        such member shall serve a 4 year term. In making such 
        appointments, the Secretary shall ensure a fair balance 
        between the nursing professions, a broad geographic 
        representation of members and a balance between urban 
        and rural members. Members shall be appointed based on 
        their competence, interest, and knowledge of the 
        mission of the profession involved. A majority of the 
        members shall be nurses.
---------------------------------------------------------------------------
    \1\ So in law. The reference to ``this Act'' means the Public 
Health Service Act, which was enacted July 1, 1944. Probably should be 
a reference to the Health Professions Education Partnerships Act of 
1998, which added section 845. That Act is Public Law 105-392, enacted 
November 13, 1998. (Section 123(5) of that Public Law (112 Stat. 3569) 
added section 845.)
---------------------------------------------------------------------------
            (3) Minority representation.--In appointing the 
        members of the Advisory Council under paragraph (1), 
        the Secretary shall ensure the adequate representation 
        of minorities.
    (c) Vacancies.--
            (1) In general.--A vacancy on the Advisory Council 
        shall be filled in the manner in which the original 
        appointment was made and shall be subject to any 
        conditions which applied with respect to the original 
        appointment.
            (2) Filling unexpired term.--An individual chosen 
        to fill a vacancy shall be appointed for the unexpired 
        term of the member replaced.
    (d) Duties.--The Advisory Council shall--
            (1) provide advice and recommendations to the 
        Secretary and Congress concerning policy matters 
        arising in the administration of this title, including 
        the range of issues relating to the nurse workforce, 
        education, and practice improvement;
            (2) provide advice to the Secretary and Congress in 
        the preparation of general regulations and with respect 
        to policy matters arising in the administration of this 
        title, including the range of issues relating to nurse 
        supply, education and practice improvement; and
            (3) not later than 3 years after the date of 
        enactment of this section, and annually thereafter, 
        prepare and submit to the Secretary, the Committee on 
        Labor and Human Resources of the Senate, and the 
        Committee on Commerce of the House of Representatives, 
        a report describing the activities of the Council, 
        including findings and recommendations made by the 
        Council concerning the activities under this title.
    (e) Meetings and Documents.--
            (1) Meetings.--The Advisory Council shall meet not 
        less than 2 times each year. Such meetings shall be 
        held jointly with other related entities established 
        under this title where appropriate.
            (2) Documents.--Not later than 14 days prior to the 
        convening of a meeting under paragraph (1), the 
        Advisory Council shall prepare and make available an 
        agenda of the matters to be considered by the Advisory 
        Council at such meeting. At any such meeting, the 
        Advisory Council shall distribute materials with 
        respect to the issues to be addressed at the meeting. 
        Not later than 30 days after the adjourning of such a 
        meeting, the Advisory Council shall prepare and make 
        available a summary of the meeting and any actions 
        taken by the Council based upon the meeting.
    (f) Compensation and Expenses.--
            (1) Compensation.--Each member of the Advisory 
        Council shall be compensated at a rate equal to the 
        daily equivalent of the annual rate of basic pay 
        prescribed for level IV of the Executive Schedule under 
        section 5315 of title 5, United States Code, for each 
        day (including travel time) during which such member is 
        engaged in the performance of the duties of the 
        Council. All members of the Council who are officers or 
        employees of the United States shall serve without 
        compensation in addition to that received for their 
        services as officers or employees of the United States.
            (2) Expenses.--The members of the Advisory Council 
        shall be allowed travel expenses, including per diem in 
        lieu of subsistence, at rates authorized for employees 
        of agencies under subchapter I of chapter 57 of title 
        5, United States Code, while away from their homes or 
        regular places of business in the performance of 
        services for the Council.
    (g) Funding.--Amounts appropriated under this title may be 
utilized by the Secretary to support the nurse education and 
practice activities of the Council.
    (h) FACA.--The Federal Advisory Committee Act shall apply 
to the Advisory Committee under this section only to the extent 
that the provisions of such Act do not conflict with the 
requirements of this section.

                  PART G--PUBLIC SERVICE ANNOUNCEMENTS

SEC. 861. [297W] PUBLIC SERVICE ANNOUNCEMENTS.

    (a) In General.--The Secretary shall develop and issue 
public service announcements that advertise and promote the 
nursing profession, highlight the advantages and rewards of 
nursing, and encourage individuals to enter the nursing 
profession.
    (b) Method.--The public service announcements described in 
subsection (a) shall be broadcast through appropriate media 
outlets, including television or radio, in a manner intended to 
reach as wide and diverse an audience as possible.
    (c) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section such sums as may 
be necessary for each of fiscal years 2003 through 2007.

SEC. 862. [297X] STATE AND LOCAL PUBLIC SERVICE ANNOUNCEMENTS.

    (a) In General.--The Secretary may award grants to eligible 
entities to support State and local advertising campaigns 
through appropriate media outlets to promote the nursing 
profession, highlight the advantages and rewards of nursing, 
and encourage individuals from disadvantaged backgrounds to 
enter the nursing profession.
    (b) Use of Funds.--An eligible entity that receives a grant 
under subsection (a) shall use funds received through such 
grant to acquire local television and radio time, place 
advertisements in local newspapers, or post information on 
billboards or on the Internet in a manner intended to reach as 
wide and diverse an audience as possible, in order to--
            (1) advertise and promote the nursing profession;
            (2) promote nursing education programs;
            (3) inform the public of financial assistance 
        regarding such education programs;
            (4) highlight individuals in the community who are 
        practicing nursing in order to recruit new nurses; or
            (5) provide any other information to recruit 
        individuals for the nursing profession.
    (c) Limitation.--An eligible entity that receives a grant 
under subsection (a) shall not use funds received through such 
grant to advertise particular employment opportunities.
    (d) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section such sums as may 
be necessary for each of fiscal years 2003 through 2007.

               PART H--COMPREHENSIVE GERIATRIC EDUCATION

SEC. 865. [298] COMPREHENSIVE GERIATRIC EDUCATION.

    (a) Program Authorized.--The Secretary shall award grants 
to eligible entities to develop and implement, in coordination 
with programs under section 753, programs and initiatives to 
train and educate individuals in providing geriatric care for 
the elderly.
    (b) Use of Funds.--An eligible entity that receives a grant 
under subsection (a) shall use funds under such grant to--
            (1) provide training to individuals who will 
        provide geriatric care for the elderly;
            (2) develop and disseminate curricula relating to 
        the treatment of the health problems of elderly 
        individuals;
            (3) train faculty members in geriatrics;
            (4) provide continuing education to individuals who 
        provide geriatric care; or
            (5) establish traineeships for individuals who are 
        preparing for advanced education nursing degrees in 
        geriatric nursing, long-term care, gero-psychiatric 
        nursing or other nursing areas that specialize in the 
        care of the elderly population.
    (c) Application.--An eligible entity desiring a grant under 
subsection (a) shall submit an application to the Secretary at 
such time, in such manner, and containing such information as 
the Secretary may reasonably require.
    (d) Eligible Entity.--For purposes of this section, the 
term ``eligible entity'' includes a school of nursing, a health 
care facility, a program leading to certification as a 
certified nurse assistant, a partnership of such a school and 
facility, or a partnership of such a program and facility.
    (e) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section such sums as may 
be necessary for each of fiscal years 2010 through 2014.

                            PART I--FUNDING

SEC. 871. [298D] AUTHORIZATION OF APPROPRIATIONS.

    For the purpose of carrying out parts B, C, and D (subject 
to section 851(g)), there are authorized to be appropriated 
$338,000,000 for fiscal year 2010, and such sums as may be 
necessary for each of the fiscal years 2011 through 
2016.ATTORNEY: PMG/FD (Dec. 29, 1999) deg.
        TITLE IX--AGENCY FOR HEALTHCARE RESEARCH AND QUALITY \1\
---------------------------------------------------------------------------

    \1\ Section 2 of Public Law 106-129 (113 Stat. 1653) designated the 
Agency as the Agency for Healthcare Research and Quality. Formerly it 
was designated as the Agency for Health Care Policy and Research. See 
section 6103 of Public Law 101-239 (103 Stat. 2189).
---------------------------------------------------------------------------

                PART A--ESTABLISHMENT AND GENERAL DUTIES

SEC. 901. [299] MISSION AND DUTIES.

    (a) In General.--There is established within the Public 
Health Service an agency to be known as the Agency for 
Healthcare Research and Quality, which shall be headed by a 
director appointed by the Secretary. The Secretary shall carry 
out this title acting through the Director.
    (b) Mission.--The purpose of the Agency is to enhance the 
quality, appropriateness, and effectiveness of health services, 
and access to such services, through the establishment of a 
broad base of scientific research and through the promotion of 
improvements in clinical and health system practices, including 
the prevention of diseases and other health conditions. The 
Agency shall promote health care quality improvement by 
conducting and supporting--
            (1) research that develops and presents scientific 
        evidence regarding all aspects of health care, 
        including--
                    (A) the development and assessment of 
                methods for enhancing patient participation in 
                their own care and for facilitating shared 
                patient-physician decision-making;
                    (B) the outcomes, effectiveness, and cost-
                effectiveness of health care practices, 
                including preventive measures and long-term 
                care;
                    (C) existing and innovative technologies;
                    (D) the costs and utilization of, and 
                access to health care;
                    (E) the ways in which health care services 
                are organized, delivered, and financed and the 
                interaction and impact of these factors on the 
                quality of patient care;
                    (F) methods for measuring quality and 
                strategies for improving quality; and
                    (G) ways in which patients, consumers, 
                purchasers, and practitioners acquire new 
                information about best practices and health 
                benefits, the determinants and impact of their 
                use of this information;
            (2) the synthesis and dissemination of available 
        scientific evidence for use by patients, consumers, 
        practitioners, providers, purchasers, policy makers, 
        and educators; and
            (3) initiatives to advance private and public 
        efforts to improve health care quality.
    (c) Requirements With Respect to Rural and Inner-City Areas 
and Priority Populations.--
            (1) Research, evaluations and demonstration 
        projects.--In carrying out this title, the Director 
        shall conduct and support research and evaluations, and 
        support demonstration projects, with respect to--
                    (A) the delivery of health care in inner-
                city areas, and in rural areas (including 
                frontier areas); and
                    (B) health care for priority populations, 
                which shall include--
                            (i) low-income groups;
                            (ii) minority groups;
                            (iii) women;
                            (iv) children;
                            (v) the elderly; and
                            (vi) individuals with special 
                        health care needs, including 
                        individuals with disabilities and 
                        individuals who need chronic care or 
                        end-of-life health care.
            (2) Process to ensure appropriate research.--The 
        Director shall establish a process to ensure that the 
        requirements of paragraph (1) are reflected in the 
        overall portfolio of research conducted and supported 
        by the Agency.
            (3) Office of priority populations.--The Director 
        shall establish an Office of Priority Populations to 
        assist in carrying out the requirements of paragraph 
        (1).

SEC. 902. [299A] GENERAL AUTHORITIES.

    (a) In General.--In carrying out section 901(b), the 
Director shall conduct and support research, evaluations, and 
training, support demonstration projects, research networks, 
and multidisciplinary centers, provide technical assistance, 
and disseminate information on health care and on systems for 
the delivery of such care, including activities with respect 
to--
            (1) the quality, effectiveness, efficiency, 
        appropriateness and value of health care services;
            (2) quality measurement and improvement;
            (3) the outcomes, cost, cost-effectiveness, and use 
        of health care services and access to such services;
            (4) clinical practice, including primary care and 
        practice-oriented research;
            (5) health care technologies, facilities, and 
        equipment;
            (6) health care costs, productivity, organization, 
        and market forces;
            (7) health promotion and disease prevention, 
        including clinical preventive services;
            (8) health statistics, surveys, database 
        development, and epidemiology; and
            (9) medical liability.
    (b) Health Services Training Grants.--
            (1) In general.--The Director may provide training 
        grants in the field of health services research related 
        to activities authorized under subsection (a), to 
        include pre- and post-doctoral fellowships and training 
        programs, young investigator awards, and other programs 
        and activities as appropriate. In carrying out this 
        subsection, the Director shall make use of funds made 
        available under section 487(d)(3) as well as other 
        appropriated funds.
            (2) Requirements.--In developing priorities for the 
        allocation of training funds under this subsection, the 
        Director shall take into consideration shortages in the 
        number of trained researchers who are addressing health 
        care issues for the priority populations identified in 
        section 901(c)(1)(B) and in addition, shall take into 
        consideration indications of long-term commitment, 
        amongst applicants for training funds, to addressing 
        health care needs of the priority populations.
    (c) Multidisciplinary Centers.--The Director may provide 
financial assistance to assist in meeting the costs of planning 
and establishing new centers, and operating existing and new 
centers, for multidisciplinary health services research, 
demonstration projects, evaluations, training, and policy 
analysis with respect to the matters referred to in subsection 
(a).
    (d) Relation to Certain Authorities Regarding Social 
Security.--Activities authorized in this section shall be 
appropriately coordinated with experiments, demonstration 
projects, and other related activities authorized by the Social 
Security Act and the Social Security Amendments of 1967. 
Activities under subsection (a)(2) of this section that affect 
the programs under titles XVIII, XIX and XXI of the Social 
Security Act shall be carried out consistent with section 1142 
of such Act.
    (e) Disclaimer.--The Agency shall not mandate national 
standards of clinical practice or quality health care 
standards. Recommendations resulting from projects funded and 
published by the Agency shall include a corresponding 
disclaimer.
    (f) Rule of Construction.--Nothing in this section shall be 
construed to imply that the Agency's role is to mandate a 
national standard or specific approach to quality measurement 
and reporting. In research and quality improvement activities, 
the Agency shall consider a wide range of choices, providers, 
health care delivery systems, and individual preferences.

SEC. 903. [299A-1] RESEARCH ON HEALTH DISPARITIES.

    (a) In General.--The Director shall--
            (1) conduct and support research to identify 
        populations for which there is a significant disparity 
        in the quality, outcomes, cost, or use of health care 
        services or access to and satisfaction with such 
        services, as compared to the general population;
            (2) conduct and support research on the causes of 
        and barriers to reducing the health disparities 
        identified in paragraph (1), taking into account such 
        factors as socioeconomic status, attitudes toward 
        health, the language spoken, the extent of formal 
        education, the area or community in which the 
        population resides, and other factors the Director 
        determines to be appropriate;
            (3) conduct and support research and support 
        demonstration projects to identify, test, and evaluate 
        strategies for reducing or eliminating health 
        disparities, including development or identification of 
        effective service delivery models, and disseminate 
        effective strategies and models;
            (4) develop measures and tools for the assessment 
        and improvement of the outcomes, quality, and 
        appropriateness of health care services provided to 
        health disparity populations;
            (5) in carrying out section 902(c), provide support 
        to increase the number of researchers who are members 
        of health disparity populations, and the health 
        services research capacity of institutions that train 
        such researchers; and
            (6) beginning with fiscal year 2003, annually 
        submit to the Congress a report regarding prevailing 
        disparities in health care delivery as it relates to 
        racial factors and socioeconomic factors in priority 
        populations.
    (b) Research and Demonstration Projects.--
            (1) In general.--In carrying out subsection (a), 
        the Director shall conduct and support research and 
        support demonstrations to--
                    (A) identify the clinical, cultural, 
                socioeconomic, geographic, and organizational 
                factors that contribute to health disparities, 
                including minority health disparity 
                populations, which research shall include 
                behavioral research, such as examination of 
                patterns of clinical decisionmaking, and 
                research on access, outreach, and the 
                availability of related support services (such 
                as cultural and linguistic services);
                    (B) identify and evaluate clinical and 
                organizational strategies to improve the 
                quality, outcomes, and access to care for 
                health disparity populations, including 
                minority health disparity populations;
                    (C) test such strategies and widely 
                disseminate those strategies for which there is 
                scientific evidence of effectiveness; and
                    (D) determine the most effective approaches 
                for disseminating research findings to health 
                disparity populations, including minority 
                populations.
            (2) Use of certain strategies.--In carrying out 
        this section, the Director shall implement research 
        strategies and mechanisms that will enhance the 
        involvement of individuals who are members of minority 
        health disparity populations or other health disparity 
        populations, health services researchers who are such 
        individuals, institutions that train such individuals 
        as researchers, members of minority health disparity 
        populations or other health disparity populations for 
        whom the Agency is attempting to improve the quality 
        and outcomes of care, and representatives of 
        appropriate tribal or other community-based 
        organizations with respect to health disparity 
        populations. Such research strategies and mechanisms 
        may include the use of--
                    (A) centers of excellence that can 
                demonstrate, either individually or through 
                consortia, a combination of multi-disciplinary 
                expertise in outcomes or quality improvement 
                research, linkages to relevant sites of care, 
                and a demonstrated capacity to involve members 
                and communities of health disparity 
                populations, including minority health 
                disparity populations, in the planning, 
                conduct, dissemination, and translation of 
                research;
                    (B) provider-based research networks, 
                including health plans, facilities, or delivery 
                system sites of care (especially primary care), 
                that make extensive use of health care 
                providers who are members of health disparity 
                populations or who serve patients in such 
                populations and have the capacity to evaluate 
                and promote quality improvement;
                    (C) service delivery models (such as health 
                centers under section 330 and the Indian Health 
                Service) to reduce health disparities; and
                    (D) innovative mechanisms or strategies 
                that will facilitate the translation of past 
                research investments into clinical practices 
                that can reasonably be expected to benefit 
                these populations.
    (c) Quality Measurement Development.--
            (1) In general.--To ensure that health disparity 
        populations, including minority health disparity 
        populations, benefit from the progress made in the 
        ability of individuals to measure the quality of health 
        care delivery, the Director shall support the 
        development of quality of health care measures that 
        assess the experience of such populations with health 
        care systems, such as measures that assess the access 
        of such populations to health care, the cultural 
        competence of the care provided, the quality of the 
        care provided, the outcomes of care, or other aspects 
        of health care practice that the Director determines to 
        be important.
            (2) Examination of certain practices.--The Director 
        shall examine the practices of providers that have a 
        record of reducing health disparities or have 
        experience in providing culturally competent health 
        services to minority health disparity populations or 
        other health disparity populations. In examining such 
        practices of providers funded under the authorities of 
        this Act, the Director shall consult with the heads of 
        the relevant agencies of the Public Health Service.
            (3) Report.--Not later than 36 months after the 
        date of the enactment of this section, the Secretary, 
        acting through the Director, shall prepare and submit 
        to the appropriate committees of Congress a report 
        describing the state-of-the-art of quality measurement 
        for minority and other health disparity populations 
        that will identify critical unmet needs, the current 
        activities of the Department to address those needs, 
        and a description of related activities in the private 
        sector.
    (d) Definition.--For purposes of this section:
            (1) The term ``health disparity population'' has 
        the meaning given such term in section 464z-3, except 
        that in addition to the meaning so given, the Director 
        may determine that such term includes populations for 
        which there is a significant disparity in the quality, 
        outcomes, cost, or use of health care services or 
        access to or satisfaction with such services as 
        compared to the general population.
            (2) The term ``minority'', with respect to 
        populations, refers to racial and ethnic minority 
        groups as defined in section 1707.

                PART B--HEALTH CARE IMPROVEMENT RESEARCH

SEC. 911. [299B] HEALTH CARE OUTCOME IMPROVEMENT RESEARCH.

    (a) Evidence Rating Systems.--In collaboration with experts 
from the public and private sector, the Agency shall identify 
and disseminate methods or systems to assess health care 
research results, particularly methods or systems to rate the 
strength of the scientific evidence underlying health care 
practice, recommendations in the research literature, and 
technology assessments. The Agency shall make methods or 
systems for evidence rating widely available. Agency 
publications containing health care recommendations shall 
indicate the level of substantiating evidence using such 
methods or systems.
    (b) Health Care Improvement Research Centers and Provider-
Based Research Networks.--
            (1) In general.--In order to address the full 
        continuum of care and outcomes research, to link 
        research to practice improvement, and to speed the 
        dissemination of research findings to community 
        practice settings, the Agency shall employ research 
        strategies and mechanisms that will link research 
        directly with clinical practice in geographically 
        diverse locations throughout the United States, 
        including--
                    (A) health care improvement research 
                centers that combine demonstrated 
                multidisciplinary expertise in outcomes or 
                quality improvement research with linkages to 
                relevant sites of care;
                    (B) provider-based research networks, 
                including plan, facility, or delivery system 
                sites of care (especially primary care), that 
                can evaluate outcomes and evaluate and promote 
                quality improvement; and
                    (C) other innovative mechanisms or 
                strategies to link research with clinical 
                practice.
            (2) Requirements.--The Director is authorized to 
        establish the requirements for entities applying for 
        grants under this subsection.

SEC. 912. [299B-1] PRIVATE-PUBLIC PARTNERSHIPS TO IMPROVE ORGANIZATION 
                    AND DELIVERY.

    (a) Support for Efforts To Develop Information on 
Quality.--
            (1) Scientific and technical support.--In its role 
        as the principal agency for health care research and 
        quality, the Agency may provide scientific and 
        technical support for private and public efforts to 
        improve health care quality, including the activities 
        of accrediting organizations.
            (2) Role of the agency.--With respect to paragraph 
        (1), the role of the Agency shall include--
                    (A) the identification and assessment of 
                methods for the evaluation of the health of--
                            (i) enrollees in health plans by 
                        type of plan, provider, and provider 
                        arrangements; and
                            (ii) other populations, including 
                        those receiving long-term care 
                        services;
                    (B) the ongoing development, testing, and 
                dissemination of quality measures, including 
                measures of health and functional outcomes;
                    (C) the compilation and dissemination of 
                health care quality measures developed in the 
                private and public sector;
                    (D) assistance in the development of 
                improved health care information systems;
                    (E) the development of survey tools for the 
                purpose of measuring participant and 
                beneficiary assessments of their health care; 
                and
                    (F) identifying and disseminating 
                information on mechanisms for the integration 
                of information on quality into purchaser and 
                consumer decision-making processes.
    (b) Centers for Education and Research on Therapeutics.--
            (1) In general.--The Secretary, acting through the 
        Director and in consultation with the Commissioner of 
        Food and Drugs, shall establish a program for the 
        purpose of making one or more grants for the 
        establishment and operation of one or more centers to 
        carry out the activities specified in paragraph (2).
            (2) Required activities.--The activities referred 
        to in this paragraph are the following:
                    (A) The conduct of state-of-the-art 
                research for the following purposes:
                            (i) To increase awareness of--
                                    (I) new uses of drugs, 
                                biological products, and 
                                devices;
                                    (II) ways to improve the 
                                effective use of drugs, 
                                biological products, and 
                                devices; and
                                    (III) risks of new uses and 
                                risks of combinations of drugs 
                                and biological products.
                            (ii) To provide objective clinical 
                        information to the following 
                        individuals and entities:
                                    (I) Health care 
                                practitioners and other 
                                providers of health care goods 
                                or services.
                                    (II) Pharmacists, pharmacy 
                                benefit managers and 
                                purchasers.
                                    (III) Health maintenance 
                                organizations and other managed 
                                health care organizations.
                                    (IV) Health care insurers 
                                and governmental agencies.
                                    (V) Patients and consumers.
                            (iii) To improve the quality of 
                        health care while reducing the cost of 
                        health care through--
                                    (I) an increase in the 
                                appropriate use of drugs, 
                                biological products, or 
                                devices; and
                                    (II) the prevention of 
                                adverse effects of drugs, 
                                biological products, and 
                                devices and the consequences of 
                                such effects, such as 
                                unnecessary hospitalizations.
                    (B) The conduct of research on the 
                comparative effectiveness, cost-effectiveness, 
                and safety of drugs, biological products, and 
                devices.
                    (C) Such other activities as the Secretary 
                determines to be appropriate, except that a 
                grant may not be expended to assist the 
                Secretary in the review of new drugs, 
                biological products, and devices.
    (c) Reducing Errors in Medicine.--The Director shall, in 
accordance with part C, conduct and support research and build 
private-public partnerships to--
            (1) identify the causes of preventable health care 
        errors and patient injury in health care delivery;
            (2) develop, demonstrate, and evaluate strategies 
        for reducing errors and improving patient safety; and
            (3) disseminate such effective strategies 
        throughout the health care industry.

SEC. 913. [299B-2] INFORMATION ON QUALITY AND COST OF CARE.

    (a) In General.--The Director shall--
            (1) conduct a survey to collect data on a 
        nationally representative sample of the population on 
        the cost, use and, for fiscal year 2001 and subsequent 
        fiscal years, quality of health care, including the 
        types of health care services Americans use, their 
        access to health care services, frequency of use, how 
        much is paid for the services used, the source of those 
        payments, the types and costs of private health 
        insurance, access, satisfaction, and quality of care 
        for the general population including rural residents 
        and also for populations identified in section 901(c); 
        and
            (2) develop databases and tools that provide 
        information to States on the quality, access, and use 
        of health care services provided to their residents.
    (b) Quality and Outcomes Information.--
            (1) In general.--Beginning in fiscal year 2001, the 
        Director shall ensure that the survey conducted under 
        subsection (a)(1) will--
                    (A) identify determinants of health 
                outcomes and functional status, including the 
                health care needs of populations identified in 
                section 901(c), provide data to study the 
                relationships between health care quality, 
                outcomes, access, use, and cost, measure 
                changes over time, and monitor the overall 
                national impact of Federal and State policy 
                changes on health care;
                    (B) provide information on the quality of 
                care and patient outcomes for frequently 
                occurring clinical conditions for a nationally 
                representative sample of the population 
                including rural residents; and
                    (C) provide reliable national estimates for 
                children and persons with special health care 
                needs through the use of supplements or 
                periodic expansions of the survey.
        In expanding the Medical Expenditure Panel Survey, as 
        in existence on the date of the enactment of this title 
        in fiscal year 2001 to collect information on the 
        quality of care, the Director shall take into account 
        any outcomes measurements generally collected by 
        private sector accreditation organizations.
            (2) Annual report.--Beginning in fiscal year 2003, 
        the Secretary, acting through the Director, shall 
        submit to Congress an annual report on national trends 
        in the quality of health care provided to the American 
        people.

SEC. 914. [299B-3] INFORMATION SYSTEMS FOR HEALTH CARE IMPROVEMENT.

    (a) In General.--In order to foster a range of innovative 
approaches to the management and communication of health 
information, the Agency shall conduct and support research, 
evaluations, and initiatives to advance--
            (1) the use of information systems for the study of 
        health care quality and outcomes, including the 
        generation of both individual provider and plan-level 
        comparative performance data;
            (2) training for health care practitioners and 
        researchers in the use of information systems;
            (3) the creation of effective linkages between 
        various sources of health information, including the 
        development of information networks;
            (4) the delivery and coordination of evidence-based 
        health care services, including the use of real-time 
        health care decision-support programs;
            (5) the utility and comparability of health 
        information data and medical vocabularies by addressing 
        issues related to the content, structure, definitions 
        and coding of such information and data in consultation 
        with appropriate Federal, State and private entities;
            (6) the use of computer-based health records in all 
        settings for the development of personal health records 
        for individual health assessment and maintenance, and 
        for monitoring public health and outcomes of care 
        within populations; and
            (7) the protection of individually identifiable 
        information in health services research and health care 
        quality improvement.
    (b) Demonstration.--The Agency shall support demonstrations 
into the use of new information tools aimed at improving shared 
decision-making between patients and their care-givers.
    (c) Facilitating Public Access to Information.--The 
Director shall work with appropriate public and private sector 
entities to facilitate public access to information regarding 
the quality of and consumer satisfaction with health care.

SEC. 915. [299B-4] RESEARCH SUPPORTING PRIMARY CARE AND ACCESS IN 
                    UNDERSERVED AREAS.

    (a) Preventive Services Task Force.--
            (1) Establishment and purpose.--The Director shall 
        convene an independent Preventive Services Task Force 
        (referred to in this subsection as the ``Task Force'') 
        to be composed of individuals with appropriate 
        expertise. Such Task Force shall review the scientific 
        evidence related to the effectiveness, appropriateness, 
        and cost-effectiveness of clinical preventive services 
        for the purpose of developing recommendations for the 
        health care community, and updating previous clinical 
        preventive recommendations, to be published in the 
        Guide to Clinical Preventive Services (referred to in 
        this section as the ``Guide''), for individuals and 
        organizations delivering clinical services, including 
        primary care professionals, health care systems, 
        professional societies, employers, community 
        organizations, non-profit organizations, Congress and 
        other policy-makers, governmental public health 
        agencies, health care quality organizations, and 
        organizations developing national health objectives. 
        Such recommendations shall consider clinical preventive 
        best practice recommendations from the Agency for 
        Healthcare Research and Quality, the National 
        Institutes of Health, the Centers for Disease Control 
        and Prevention, the Institute of Medicine, specialty 
        medical associations, patient groups, and scientific 
        societies.
            (2) Duties.--The duties of the Task Force shall 
        include--
                    (A) the development of additional topic 
                areas for new recommendations and interventions 
                related to those topic areas, including those 
                related to specific sub-populations and age 
                groups;
                    (B) at least once during every 5-year 
                period, review interventions and update 
                recommendations related to existing topic 
                areas, including new or improved techniques to 
                assess the health effects of interventions;
                    (C) improved integration with Federal 
                Government health objectives and related target 
                setting for health improvement;
                    (D) the enhanced dissemination of 
                recommendations;
                    (E) the provision of technical assistance 
                to those health care professionals, agencies 
                and organizations that request help in 
                implementing the Guide recommendations; and
                    (F) the submission of yearly reports to 
                Congress and related agencies identifying gaps 
                in research, such as preventive services that 
                receive an insufficient evidence statement, and 
                recommending priority areas that deserve 
                further examination, including areas related to 
                populations and age groups not adequately 
                addressed by current recommendations.
            (3) Role of agency.--The Agency shall provide 
        ongoing administrative, research, and technical support 
        for the operations of the Task Force, including 
        coordinating and supporting the dissemination of the 
        recommendations of the Task Force, ensuring adequate 
        staff resources, and assistance to those organizations 
        requesting it for implementation of the Guide's 
        recommendations.
            (4) Coordination with community preventive services 
        task force.--The Task Force shall take appropriate 
        steps to coordinate its work with the Community 
        Preventive Services Task Force and the Advisory 
        Committee on Immunization Practices, including the 
        examination of how each task force's recommendations 
        interact at the nexus of clinic and community.
            (5) Operation.--Operation. In carrying out the 
        duties under paragraph (2), the Task Force is not 
        subject to the provisions of Appendix 2 of title 5, 
        United States Code.
            (6) Independence.--All members of the Task Force 
        convened under this subsection, and any recommendations 
        made by such members, shall be independent and, to the 
        extent practicable, not subject to political pressure.
            (7) Authorization of appropriations.--There are 
        authorized to be appropriated such sums as may be 
        necessary for each fiscal year to carry out the 
        activities of the Task Force.
    (b) Primary Care Research.--
            (1) In general.--There is established within the 
        Agency a Center for Primary Care Research (referred to 
        in this subsection as the ``Center'') that shall serve 
        as the principal source of funding for primary care 
        practice research in the Department of Health and Human 
        Services. For purposes of this paragraph, primary care 
        research focuses on the first contact when illness or 
        health concerns arise, the diagnosis, treatment or 
        referral to specialty care, preventive care, and the 
        relationship between the clinician and the patient in 
        the context of the family and community.
            (2) Research.--In carrying out this section, the 
        Center shall conduct and support research concerning--
                    (A) the nature and characteristics of 
                primary care practice;
                    (B) the management of commonly occurring 
                clinical problems;
                    (C) the management of undifferentiated 
                clinical problems; and
                    (D) the continuity and coordination of 
                health services.

SEC. 916. [299B-5] HEALTH CARE PRACTICE AND TECHNOLOGY INNOVATION.

    (a) In General.--The Director shall promote innovation in 
evidence-based health care practices and technologies by--
            (1) conducting and supporting research on the 
        development, diffusion, and use of health care 
        technology;
            (2) developing, evaluating, and disseminating 
        methodologies for assessments of health care practices 
        and technologies;
            (3) conducting intramural and supporting extramural 
        assessments of existing and new health care practices 
        and technologies;
            (4) promoting education and training and providing 
        technical assistance in the use of health care practice 
        and technology assessment methodologies and results; 
        and
            (5) working with the National Library of Medicine 
        and the public and private sector to develop an 
        electronic clearinghouse of currently available 
        assessments and those in progress.
    (b) Specification of Process.--
            (1) In general.--Not later than December 31, 2000, 
        the Director shall develop and publish a description of 
        the methods used by the Agency and its contractors for 
        health care practice and technology assessment.
            (2) Consultations.--In carrying out this 
        subsection, the Director shall cooperate and consult 
        with the Assistant Secretary for Health, the 
        Administrator of the Centers for Medicare & Medicaid 
        Services, the Director of the National Institutes of 
        Health, the Commissioner of Food and Drugs, and the 
        heads of any other interested Federal department or 
        agency, and shall seek input, where appropriate, from 
        professional societies and other private and public 
        entities.
            (3) Methodology.--The Director shall, in developing 
        the methods used under paragraph (1), consider--
                    (A) safety, efficacy, and effectiveness;
                    (B) legal, social, and ethical 
                implications;
                    (C) costs, benefits, and cost-
                effectiveness;
                    (D) comparisons to alternate health care 
                practices and technologies; and
                    (E) requirements of Food and Drug 
                Administration approval to avoid duplication.
    (c) Specific Assessments.--
            (1) In general.--The Director shall conduct or 
        support specific assessments of health care 
        technologies and practices.
            (2) Requests for assessments.--The Director is 
        authorized to conduct or support assessments, on a 
        reimbursable basis, for the Centers for Medicare & 
        Medicaid Services, the Department of Defense, the 
        Department of Veterans Affairs, the Office of Personnel 
        Management, and other public or private entities.
            (3) Grants and contracts.--In addition to 
        conducting assessments, the Director may make grants 
        to, or enter into cooperative agreements or contracts 
        with, entities described in paragraph (4) for the 
        purpose of conducting assessments of experimental, 
        emerging, existing, or potentially outmoded health care 
        technologies, and for related activities.
            (4) Eligible entities.--An entity described in this 
        paragraph is an entity that is determined to be 
        appropriate by the Director, including academic medical 
        centers, research institutions and organizations, 
        professional organizations, third party payers, 
        governmental agencies, minority institutions of higher 
        education (such as Historically Black Colleges and 
        Universities, and Hispanic institutions), and consortia 
        of appropriate research entities established for the 
        purpose of conducting technology assessments.
    (d) Medical Examination of Certain Victims.--
            (1) In general.--The Director shall develop and 
        disseminate a report on evidence-based clinical 
        practices for--
                    (A) the examination and treatment by health 
                professionals of individuals who are victims of 
                sexual assault (including child molestation) or 
                attempted sexual assault; and
                    (B) the training of health professionals, 
                in consultation with the Health Resources and 
                Services Administration, on performing medical 
                evidentiary examinations of individuals who are 
                victims of child abuse or neglect, sexual 
                assault, elder abuse, or domestic violence.
            (2) Certain considerations.--In identifying the 
        issues to be addressed by the report, the Director 
        shall, to the extent practicable, take into 
        consideration the expertise and experience of Federal 
        and State law enforcement officials regarding the 
        victims referred to in paragraph (1), and of other 
        appropriate public and private entities (including 
        medical societies, victim services organizations, 
        sexual assault prevention organizations, and social 
        services organizations).

SEC. 917. [299B-6] COORDINATION OF FEDERAL GOVERNMENT QUALITY 
                    IMPROVEMENT EFFORTS.

    (a) Requirement.--
            (1) In general.--To avoid duplication and ensure 
        that Federal resources are used efficiently and 
        effectively, the Secretary, acting through the 
        Director, shall coordinate all research, evaluations, 
        and demonstrations related to health services research, 
        quality measurement and quality improvement activities 
        undertaken and supported by the Federal Government.
            (2) Specific activities.--The Director, in 
        collaboration with the appropriate Federal officials 
        representing all concerned executive agencies and 
        departments, shall develop and manage a process to--
                    (A) improve interagency coordination, 
                priority setting, and the use and sharing of 
                research findings and data pertaining to 
                Federal quality improvement programs, 
                technology assessment, and health services 
                research;
                    (B) strengthen the research information 
                infrastructure, including databases, pertaining 
                to Federal health services research and health 
                care quality improvement initiatives;
                    (C) set specific goals for participating 
                agencies and departments to further health 
                services research and health care quality 
                improvement; and
                    (D) strengthen the management of Federal 
                health care quality improvement programs.
    (b) Study by the Institute of Medicine.--
            (1) In general.--To provide Congress, the 
        Department of Health and Human Services, and other 
        relevant departments with an independent, external 
        review of their quality oversight, quality improvement 
        and quality research programs, the Secretary shall 
        enter into a contract with the Institute of Medicine--
                    (A) to describe and evaluate current 
                quality improvement, quality research and 
                quality monitoring processes through--
                            (i) an overview of pertinent health 
                        services research activities and 
                        quality improvement efforts conducted 
                        by all Federal programs, with 
                        particular attention paid to those 
                        under titles XVIII, XIX, and XXI of the 
                        Social Security Act; and
                            (ii) a summary of the partnerships 
                        that the Department of Health and Human 
                        Services has pursued with private 
                        accreditation, quality measurement and 
                        improvement organizations; and
                    (B) to identify options and make 
                recommendations to improve the efficiency and 
                effectiveness of quality improvement programs 
                through--
                            (i) the improved coordination of 
                        activities across the medicare, 
                        medicaid and child health insurance 
                        programs under titles XVIII, XIX and 
                        XXI of the Social Security Act and 
                        health services research programs;
                            (ii) the strengthening of patient 
                        choice and participation by 
                        incorporating state-of-the-art quality 
                        monitoring tools and making information 
                        on quality available; and
                            (iii) the enhancement of the most 
                        effective programs, consolidation as 
                        appropriate, and elimination of 
                        duplicative activities within various 
                        Federal agencies.
            (2) Requirements.--
                    (A) In general.--The Secretary shall enter 
                into a contract with the Institute of Medicine 
                for the preparation--
                            (i) not later than 12 months after 
                        the date of the enactment of this 
                        title, of a report providing an 
                        overview of the quality improvement 
                        programs of the Department of Health 
                        and Human Services for the medicare, 
                        medicaid, and CHIP programs under 
                        titles XVIII, XIX, and XXI of the 
                        Social Security Act; and
                            (ii) not later than 24 months after 
                        the date of the enactment of this 
                        title, of a final report containing 
                        recommendations.
                    (B) Reports.--The Secretary shall submit 
                the reports described in subparagraph (A) to 
                the Committee on Finance and the Committee on 
                Health, Education, Labor, and Pensions of the 
                Senate and the Committee on Ways and Means and 
                the Committee on Commerce of the House of 
                Representatives.

                   PART C--PATIENT SAFETY IMPROVEMENT

SEC. 921. [299B-21] DEFINITIONS.

    In this part:
            (1) HIPAA confidentiality regulations.--The term 
        ``HIPAA confidentiality regulations'' means regulations 
        promulgated under section 264(c) of the Health 
        Insurance Portability and Accountability Act of 1996 
        (Public Law 104-191; 110 Stat. 2033).
            (2) Identifiable patient safety work product.--The 
        term ``identifiable patient safety work product'' means 
        patient safety work product that--
                    (A) is presented in a form and manner that 
                allows the identification of any provider that 
                is a subject of the work product, or any 
                providers that participate in activities that 
                are a subject of the work product;
                    (B) constitutes individually identifiable 
                health information as that term is defined in 
                the HIPAA confidentiality regulations; or
                    (C) is presented in a form and manner that 
                allows the identification of an individual who 
                reported information in the manner specified in 
                section 922(e).
            (3) Nonidentifiable patient safety work product.--
        The term ``nonidentifiable patient safety work 
        product'' means patient safety work product that is not 
        identifiable patient safety work product (as defined in 
        paragraph (2)).
            (4) Patient safety organization.--The term 
        ``patient safety organization'' means a private or 
        public entity or component thereof that is listed by 
        the Secretary pursuant to section 924(d).
            (5) Patient safety activities.--The term ``patient 
        safety activities'' means the following activities:
                    (A) Efforts to improve patient safety and 
                the quality of health care delivery.
                    (B) The collection and analysis of patient 
                safety work product.
                    (C) The development and dissemination of 
                information with respect to improving patient 
                safety, such as recommendations, protocols, or 
                information regarding best practices.
                    (D) The utilization of patient safety work 
                product for the purposes of encouraging a 
                culture of safety and of providing feedback and 
                assistance to effectively minimize patient 
                risk.
                    (E) The maintenance of procedures to 
                preserve confidentiality with respect to 
                patient safety work product.
                    (F) The provision of appropriate security 
                measures with respect to patient safety work 
                product.
                    (G) The utilization of qualified staff.
                    (H) Activities related to the operation of 
                a patient safety evaluation system and to the 
                provision of feedback to participants in a 
                patient safety evaluation system.
            (6) Patient safety evaluation system.--The term 
        ``patient safety evaluation system'' means the 
        collection, management, or analysis of information for 
        reporting to or by a patient safety organization.
            (7) Patient safety work product.--
                    (A) In general.--Except as provided in 
                subparagraph (B), the term ``patient safety 
                work product'' means any data, reports, 
                records, memoranda, analyses (such as root 
                cause analyses), or written or oral 
                statements--
                            (i) which--
                                    (I) are assembled or 
                                developed by a provider for 
                                reporting to a patient safety 
                                organization and are reported 
                                to a patient safety 
                                organization; or
                                    (II) are developed by a 
                                patient safety organization for 
                                the conduct of patient safety 
                                activities;
                        and which could result in improved 
                        patient safety, health care quality, or 
                        health care outcomes; or
                            (ii) which identify or constitute 
                        the deliberations or analysis of, or 
                        identify the fact of reporting pursuant 
                        to, a patient safety evaluation system.
                    (B) Clarification.--
                            (i) Information described in 
                        subparagraph (A) does not include a 
                        patient's medical record, billing and 
                        discharge information, or any other 
                        original patient or provider record.
                            (ii) Information described in 
                        subparagraph (A) does not include 
                        information that is collected, 
                        maintained, or developed separately, or 
                        exists separately, from a patient 
                        safety evaluation system. Such separate 
                        information or a copy thereof reported 
                        to a patient safety organization shall 
                        not by reason of its reporting be 
                        considered patient safety work product.
                            (iii) Nothing in this part shall be 
                        construed to limit--
                                    (I) the discovery of or 
                                admissibility of information 
                                described in this subparagraph 
                                in a criminal, civil, or 
                                administrative proceeding;
                                    (II) the reporting of 
                                information described in this 
                                subparagraph to a Federal, 
                                State, or local governmental 
                                agency for public health 
                                surveillance, investigation, or 
                                other public health purposes or 
                                health oversight purposes; or
                                    (III) a provider's 
                                recordkeeping obligation with 
                                respect to information 
                                described in this subparagraph 
                                under Federal, State, or local 
                                law.
            (8) Provider.--The term ``provider'' means--
                    (A) an individual or entity licensed or 
                otherwise authorized under State law to provide 
                health care services, including--
                            (i) a hospital, nursing facility, 
                        comprehensive outpatient rehabilitation 
                        facility, home health agency, hospice 
                        program, renal dialysis facility, 
                        ambulatory surgical center, pharmacy, 
                        physician or health care practitioner's 
                        office, long term care facility, 
                        behavior health residential treatment 
                        facility, clinical laboratory, or 
                        health center; or
                            (ii) a physician, physician 
                        assistant, nurse practitioner, clinical 
                        nurse specialist, certified registered 
                        nurse anesthetist, certified nurse 
                        midwife, psychologist, certified social 
                        worker, registered dietitian or 
                        nutrition professional, physical or 
                        occupational therapist, pharmacist, or 
                        other individual health care 
                        practitioner; or
                    (B) any other individual or entity 
                specified in regulations promulgated by the 
                Secretary.

SEC. 922. [299B-22] PRIVILEGE AND CONFIDENTIALITY PROTECTIONS.

    (a) Privilege.--Notwithstanding any other provision of 
Federal, State, or local law, and subject to subsection (c), 
patient safety work product shall be privileged and shall not 
be--
            (1) subject to a Federal, State, or local civil, 
        criminal, or administrative subpoena or order, 
        including in a Federal, State, or local civil or 
        administrative disciplinary proceeding against a 
        provider;
            (2) subject to discovery in connection with a 
        Federal, State, or local civil, criminal, or 
        administrative proceeding, including in a Federal, 
        State, or local civil or administrative disciplinary 
        proceeding against a provider;
            (3) subject to disclosure pursuant to section 552 
        of title 5, United States Code (commonly known as the 
        Freedom of Information Act) or any other similar 
        Federal, State, or local law;
            (4) admitted as evidence in any Federal, State, or 
        local governmental civil proceeding, criminal 
        proceeding, administrative rulemaking proceeding, or 
        administrative adjudicatory proceeding, including any 
        such proceeding against a provider; or
            (5) admitted in a professional disciplinary 
        proceeding of a professional disciplinary body 
        established or specifically authorized under State law.
    (b) Confidentiality of Patient Safety Work Product.--
Notwithstanding any other provision of Federal, State, or local 
law, and subject to subsection (c), patient safety work product 
shall be confidential and shall not be disclosed.
    (c) Exceptions.--Except as provided in subsection (g)(3)--
            (1) Exceptions from privilege and 
        confidentiality.--Subsections (a) and (b) shall not 
        apply to (and shall not be construed to prohibit) one 
        or more of the following disclosures:
                    (A) Disclosure of relevant patient safety 
                work product for use in a criminal proceeding, 
                but only after a court makes an in camera 
                determination that such patient safety work 
                product contains evidence of a criminal act and 
                that such patient safety work product is 
                material to the proceeding and not reasonably 
                available from any other source.
                    (B) Disclosure of patient safety work 
                product to the extent required to carry out 
                subsection (f)(4)(A).
                    (C) Disclosure of identifiable patient 
                safety work product if authorized by each 
                provider identified in such work product.
            (2) Exceptions from confidentiality.--Subsection 
        (b) shall not apply to (and shall not be construed to 
        prohibit) one or more of the following disclosures:
                    (A) Disclosure of patient safety work 
                product to carry out patient safety activities.
                    (B) Disclosure of nonidentifiable patient 
                safety work product.
                    (C) Disclosure of patient safety work 
                product to grantees, contractors, or other 
                entities carrying out research, evaluation, or 
                demonstration projects authorized, funded, 
                certified, or otherwise sanctioned by rule or 
                other means by the Secretary, for the purpose 
                of conducting research to the extent that 
                disclosure of protected health information 
                would be allowed for such purpose under the 
                HIPAA confidentiality regulations.
                    (D) Disclosure by a provider to the Food 
                and Drug Administration with respect to a 
                product or activity regulated by the Food and 
                Drug Administration.
                    (E) Voluntary disclosure of patient safety 
                work product by a provider to an accrediting 
                body that accredits that provider.
                    (F) Disclosures that the Secretary may 
                determine, by rule or other means, are 
                necessary for business operations and are 
                consistent with the goals of this part.
                    (G) Disclosure of patient safety work 
                product to law enforcement authorities relating 
                to the commission of a crime (or to an event 
                reasonably believed to be a crime) if the 
                person making the disclosure believes, 
                reasonably under the circumstances, that the 
                patient safety work product that is disclosed 
                is necessary for criminal law enforcement 
                purposes.
                    (H) With respect to a person other than a 
                patient safety organization, the disclosure of 
                patient safety work product that does not 
                include materials that--
                            (i) assess the quality of care of 
                        an identifiable provider; or
                            (ii) describe or pertain to one or 
                        more actions or failures to act by an 
                        identifiable provider.
            (3) Exception from privilege.--Subsection (a) shall 
        not apply to (and shall not be construed to prohibit) 
        voluntary disclosure of nonidentifiable patient safety 
        work product.
    (d) Continued Protection of Information After Disclosure.--
            (1) In general.--Patient safety work product that 
        is disclosed under subsection (c) shall continue to be 
        privileged and confidential as provided for in 
        subsections (a) and (b), and such disclosure shall not 
        be treated as a waiver of privilege or confidentiality, 
        and the privileged and confidential nature of such work 
        product shall also apply to such work product in the 
        possession or control of a person to whom such work 
        product was disclosed.
            (2) Exception.--Notwithstanding paragraph (1), and 
        subject to paragraph (3)--
                    (A) if patient safety work product is 
                disclosed in a criminal proceeding, the 
                confidentiality protections provided for in 
                subsection (b) shall no longer apply to the 
                work product so disclosed; and
                    (B) if patient safety work product is 
                disclosed as provided for in subsection 
                (c)(2)(B) (relating to disclosure of 
                nonidentifiable patient safety work product), 
                the privilege and confidentiality protections 
                provided for in subsections (a) and (b) shall 
                no longer apply to such work product.
            (3) Construction.--Paragraph (2) shall not be 
        construed as terminating or limiting the privilege or 
        confidentiality protections provided for in subsection 
        (a) or (b) with respect to patient safety work product 
        other than the specific patient safety work product 
        disclosed as provided for in subsection (c).
            (4) Limitations on actions.--
                    (A) Patient safety organizations.--
                            (i) In general.--A patient safety 
                        organization shall not be compelled to 
                        disclose information collected or 
                        developed under this part whether or 
                        not such information is patient safety 
                        work product unless such information is 
                        identified, is not patient safety work 
                        product, and is not reasonably 
                        available from another source.
                            (ii) Nonapplication.--The 
                        limitation contained in clause (i) 
                        shall not apply in an action against a 
                        patient safety organization or with 
                        respect to disclosures pursuant to 
                        subsection (c)(1).
            (B) Providers.--An accrediting body shall not take 
        an accrediting action against a provider based on the 
        good faith participation of the provider in the 
        collection, development, reporting, or maintenance of 
        patient safety work product in accordance with this 
        part. An accrediting body may not require a provider to 
        reveal its communications with any patient safety 
        organization established in accordance with this part.
    (e) Reporter Protection.--
            (1) In general.--A provider may not take an adverse 
        employment action, as described in paragraph (2), 
        against an individual based upon the fact that the 
        individual in good faith reported information--
                    (A) to the provider with the intention of 
                having the information reported to a patient 
                safety organization; or
                    (B) directly to a patient safety 
                organization.
            (2) Adverse employment action.--For purposes of 
        this subsection, an ``adverse employment action'' 
        includes--
                    (A) loss of employment, the failure to 
                promote an individual, or the failure to 
                provide any other employment-related benefit 
                for which the individual would otherwise be 
                eligible; or
                    (B) an adverse evaluation or decision made 
                in relation to accreditation, certification, 
                credentialing, or licensing of the individual.
    (f) Enforcement.--
            (1) Civil monetary penalty.--Subject to paragraphs 
        (2) and (3), a person who discloses identifiable 
        patient safety work product in knowing or reckless 
        violation of subsection (b) shall be subject to a civil 
        monetary penalty of not more than $10,000 for each act 
        constituting such violation.
            (2) Procedure.--The provisions of section 1128A of 
        the Social Security Act, other than subsections (a) and 
        (b) and the first sentence of subsection (c)(1), shall 
        apply to civil money penalties under this subsection in 
        the same manner as such provisions apply to a penalty 
        or proceeding under section 1128A of the Social 
        Security Act.
            (3) Relation to hipaa.--Penalties shall not be 
        imposed both under this subsection and under the 
        regulations issued pursuant to section 264(c)(1) of the 
        Health Insurance Portability and Accountability Act of 
        1996 (42 U.S.C. 1320d-2 note) for a single act or 
        omission.
            (4) Equitable relief.--
                    (A) In general.--Without limiting remedies 
                available to other parties, a civil action may 
                be brought by any aggrieved individual to 
                enjoin any act or practice that violates 
                subsection (e) and to obtain other appropriate 
                equitable relief (including reinstatement, back 
                pay, and restoration of benefits) to redress 
                such violation.
                    (B) Against state employees.--An entity 
                that is a State or an agency of a State 
                government may not assert the privilege 
                described in subsection (a) unless before the 
                time of the assertion, the entity or, in the 
                case of and with respect to an agency, the 
                State has consented to be subject to an action 
                described in subparagraph (A), and that consent 
                has remained in effect.
    (g) Rule of Construction.--Nothing in this section shall be 
construed--
            (1) to limit the application of other Federal, 
        State, or local laws that provide greater privilege or 
        confidentiality protections than the privilege and 
        confidentiality protections provided for in this 
        section;
            (2) to limit, alter, or affect the requirements of 
        Federal, State, or local law pertaining to information 
        that is not privileged or confidential under this 
        section;
            (3) except as provided in subsection (i), to alter 
        or affect the implementation of any provision of the 
        HIPAA confidentiality regulations or section 1176 of 
        the Social Security Act (or regulations promulgated 
        under such section);
            (4) to limit the authority of any provider, patient 
        safety organization, or other entity to enter into a 
        contract requiring greater confidentiality or 
        delegating authority to make a disclosure or use in 
        accordance with this section;
            (5) as preempting or otherwise affecting any State 
        law requiring a provider to report information that is 
        not patient safety work product; or
            (6) to limit, alter, or affect any requirement for 
        reporting to the Food and Drug Administration 
        information regarding the safety of a product or 
        activity regulated by the Food and Drug Administration.
    (h) Clarification.--Nothing in this part prohibits any 
person from conducting additional analysis for any purpose 
regardless of whether such additional analysis involves issues 
identical to or similar to those for which information was 
reported to or assessed by a patient safety organization or a 
patient safety evaluation system.
    (i) Clarification of application of hipaa confidentiality 
regulations to patient safety organizations.--For purposes of 
applying the HIPAA confidentiality regulations--
            (1) patient safety organizations shall be treated 
        as business associates; and
            (2) patient safety activities of such organizations 
        in relation to a provider are deemed to be health care 
        operations (as defined in such regulations) of the 
        provider.
    (j) Reports on Strategies to Improve Patient Safety.--
            (1) Draft report.--Not later than the date that is 
        18 months after any network of patient safety databases 
        is operational, the Secretary, in consultation with the 
        Director, shall prepare a draft report on effective 
        strategies for reducing medical errors and increasing 
        patient safety. The draft report shall include any 
        measure determined appropriate by the Secretary to 
        encourage the appropriate use of such strategies, 
        including use in any federally funded programs. The 
        Secretary shall make the draft report available for 
        public comment and submit the draft report to the 
        Institute of Medicine for review.
            (2) Final report.--Not later than 1 year after the 
        date described in paragraph (1), the Secretary shall 
        submit a final report to the Congress.

SEC. 923. [299B-23] NETWORK OF PATIENT SAFETY DATABASES.

    (a) In General.--The Secretary shall facilitate the 
creation of, and maintain, a network of patient safety 
databases that provides an interactive evidence-based 
management resource for providers, patient safety 
organizations, and other entities. The network of databases 
shall have the capacity to accept, aggregate across the 
network, and analyze nonidentifiable patient safety work 
product voluntarily reported by patient safety organizations, 
providers, or other entities. The Secretary shall assess the 
feasibility of providing for a single point of access to the 
network for qualified researchers for information aggregated 
across the network and, if feasible, provide for 
implementation.
    (b) Data Standards.--The Secretary may determine common 
formats for the reporting to and among the network of patient 
safety databases maintained under subsection (a) of 
nonidentifiable patient safety work product, including 
necessary work product elements, common and consistent 
definitions, and a standardized computer interface for the 
processing of such work product. To the extent practicable, 
such standards shall be consistent with the administrative 
simplification provisions of part C of title XI of the Social 
Security Act.
    (c) Use of Information.--Information reported to and among 
the network of patient safety databases under subsection (a) 
shall be used to analyze national and regional statistics, 
including trends and patterns of health care errors. The 
information resulting from such analyses shall be made 
available to the public and included in the annual quality 
reports prepared under section 913(b)(2).

SEC. 924. [299B-24] PATIENT SAFETY ORGANIZATION CERTIFICATION AND 
                    LISTING.

    (a) Certification.--
            (1) Initial certification.--An entity that seeks to 
        be a patient safety organization shall submit an 
        initial certification to the Secretary that the 
        entity--
                    (A) has policies and procedures in place to 
                perform each of the patient safety activities 
                described in section 921(5); and
                    (B) upon being listed under subsection (d), 
                will comply with the criteria described in 
                subsection (b).
            (2) Subsequent certifications.--An entity that is a 
        patient safety organization shall submit every 3 years 
        after the date of its initial listing under subsection 
        (d) a subsequent certification to the Secretary that 
        the entity--
                    (A) is performing each of the patient 
                safety activities described in section 921(5); 
                and
                    (B) is complying with the criteria 
                described in subsection (b).
    (b) Criteria.--
            (1) In general.--The following are criteria for the 
        initial and subsequent certification of an entity as a 
        patient safety organization:
                    (A) The mission and primary activity of the 
                entity are to conduct activities that are to 
                improve patient safety and the quality of 
                health care delivery.
                    (B) The entity has appropriately qualified 
                staff (whether directly or through contract), 
                including licensed or certified medical 
                professionals.
                    (C) The entity, within each 24-month period 
                that begins after the date of the initial 
                listing under subsection (d), has bona fide 
                contracts, each of a reasonable period of time, 
                with more than 1 provider for the purpose of 
                receiving and reviewing patient safety work 
                product.
                    (D) The entity is not, and is not a 
                component of, a health insurance issuer (as 
                defined in section 2791(b)(2)).
                    (E) The entity shall fully disclose--
                            (i) any financial, reporting, or 
                        contractual relationship between the 
                        entity and any provider that contracts 
                        with the entity; and
                            (ii) if applicable, the fact that 
                        the entity is not managed, controlled, 
                        and operated independently from any 
                        provider that contracts with the 
                        entity.
                    (F) To the extent practical and 
                appropriate, the entity collects patient safety 
                work product from providers in a standardized 
                manner that permits valid comparisons of 
                similar cases among similar providers.
                    (G) The utilization of patient safety work 
                product for the purpose of providing direct 
                feedback and assistance to providers to 
                effectively minimize patient risk.
            (2) Additional criteria for component 
        organizations.--If an entity that seeks to be a patient 
        safety organization is a component of another 
        organization, the following are additional criteria for 
        the initial and subsequent certification of the entity 
        as a patient safety organization:
                    (A) The entity maintains patient safety 
                work product separately from the rest of the 
                organization, and establishes appropriate 
                security measures to maintain the 
                confidentiality of the patient safety work 
                product.
                    (B) The entity does not make an 
                unauthorized disclosure under this part of 
                patient safety work product to the rest of the 
                organization in breach of confidentiality.
                    (C) The mission of the entity does not 
                create a conflict of interest with the rest of 
                the organization.
    (c) Review of Certification.--
            (1) In general.--
                    (A) Initial certification.--Upon the 
                submission by an entity of an initial 
                certification under subsection (a)(1), the 
                Secretary shall determine if the certification 
                meets the requirements of subparagraphs (A) and 
                (B) of such subsection.
                    (B) Subsequent certification.--Upon the 
                submission by an entity of a subsequent 
                certification under subsection (a)(2), the 
                Secretary shall review the certification with 
                respect to requirements of subparagraphs (A) 
                and (B) of such subsection.
            (2) Notice of acceptance or non-acceptance.--If the 
        Secretary determines that--
                    (A) an entity's initial certification meets 
                requirements referred to in paragraph (1)(A), 
                the Secretary shall notify the entity of the 
                acceptance of such certification; or
                    (B) an entity's initial certification does 
                not meet such requirements, the Secretary shall 
                notify the entity that such certification is 
                not accepted and the reasons therefor.
            (3) Disclosures regarding relationship to 
        providers.--The Secretary shall consider any 
        disclosures under subsection (b)(1)(E) by an entity and 
        shall make public findings on whether the entity can 
        fairly and accurately perform the patient safety 
        activities of a patient safety organization. The 
        Secretary shall take those findings into consideration 
        in determining whether to accept the entity's initial 
        certification and any subsequent certification 
        submitted under subsection (a) and, based on those 
        findings, may deny, condition, or revoke acceptance of 
        the entity's certification.
    (d) Listing.--The Secretary shall compile and maintain a 
listing of entities with respect to which there is an 
acceptance of a certification pursuant to subsection (c)(2)(A) 
that has not been revoked under subsection (e) or voluntarily 
relinquished.
    (e) Revocation of Acceptance of Certification.--
            (1) In general.--If, after notice of deficiency, an 
        opportunity for a hearing, and a reasonable opportunity 
        for correction, the Secretary determines that a patient 
        safety organization does not meet the certification 
        requirements under subsection (a)(2), including 
        subparagraphs (A) and (B) of such subsection, the 
        Secretary shall revoke the Secretary's acceptance of 
        the certification of such organization.
            (2) Supplying confirmation of notification to 
        providers.--Within 15 days of a revocation under 
        paragraph (1), a patient safety organization shall 
        submit to the Secretary a confirmation that the 
        organization has taken all reasonable actions to notify 
        each provider whose patient safety work product is 
        collected or analyzed by the organization of such 
        revocation.
            (3) Publication of decision.--If the Secretary 
        revokes the certification of an organization under 
        paragraph (1), the Secretary shall--
                    (A) remove the organization from the 
                listing maintained under subsection (d); and
                    (B) publish notice of the revocation in the 
                Federal Register.
    (f) Status of Data After Removal from Listing.--
            (1) New data.--With respect to the privilege and 
        confidentiality protections described in section 922, 
        data submitted to an entity within 30 days after the 
        entity is removed from the listing under subsection 
        (e)(3)(A) shall have the same status as data submitted 
        while the entity was still listed.
            (2) Protection to continue to apply.--If the 
        privilege and confidentiality protections described in 
        section 922 applied to patient safety work product 
        while an entity was listed, or to data described in 
        paragraph (1), such protections shall continue to apply 
        to such work product or data after the entity is 
        removed from the listing under subsection (e)(3)(A).
    (g) Disposition of Work Product and Data.--If the Secretary 
removes a patient safety organization from the listing as 
provided for in subsection (e)(3)(A), with respect to the 
patient safety work product or data described in subsection 
(f)(1) that the patient safety organization received from 
another entity, such former patient safety organization shall--
            (1) with the approval of the other entity and a 
        patient safety organization, transfer such work product 
        or data to such patient safety organization;
            (2) return such work product or data to the entity 
        that submitted the work product or data; or
            (3) if returning such work product or data to such 
        entity is not practicable, destroy such work product or 
        data.

SEC. 925. [299B-24A] ACTIVITIES REGARDING WOMEN'S HEALTH.

    (a) Establishment.--There is established within the Office 
of the Director, an Office of Women's Health and Gender-Based 
Research (referred to in this section as the ``Office''). The 
Office shall be headed by a director who shall be appointed by 
the Director of Healthcare and Research Quality.
    (b) Purpose.--The official designated under subsection (a) 
shall--
            (1) report to the Director on the current Agency 
        level of activity regarding women's health, across, 
        where appropriate, age, biological, and sociocultural 
        contexts, in all aspects of Agency work, including the 
        development of evidence reports and clinical practice 
        protocols and the conduct of research into patient 
        outcomes, delivery of health care services, quality of 
        care, and access to health care;
            (2) establish short-range and long-range goals and 
        objectives within the Agency for research important to 
        women's health and, as relevant and appropriate, 
        coordinate with other appropriate offices on activities 
        within the Agency that relate to health services and 
        medical effectiveness research, for issues of 
        particular concern to women;
            (3) identify projects in women's health that should 
        be conducted or supported by the Agency;
            (4) consult with health professionals, 
        nongovernmental organizations, consumer organizations, 
        women's health professionals, and other individuals and 
        groups, as appropriate, on Agency policy with regard to 
        women; and
            (5) serve as a member of the Department of Health 
        and Human Services Coordinating Committee on Women's 
        Health (established under section 229(b)(4)).
    (c) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2010 through 2014.

SEC. 926. [299B-25] TECHNICAL ASSISTANCE.

    The Secretary, acting through the Director, may provide 
technical assistance to patient safety organizations, including 
convening annual meetings for patient safety organizations to 
discuss methodology, communication, data collection, or privacy 
concerns.

SEC. 927. [299B-26] SEVERABILITY.

    If any provision of this part is held to be 
unconstitutional, the remainder of this part shall not be 
affected.

                PART D--HEALTH CARE QUALITY IMPROVEMENT

                 Subpart I--Quality Measure Development

SEC. 931. [299B-31] QUALITY MEASURE DEVELOPMENT.

    (a) Quality Measure.--In this subpart, the term ``quality 
measure'' means a standard for measuring the performance and 
improvement of population health or of health plans, providers 
of services, and other clinicians in the delivery of health 
care services.
    (b) Identification of Quality Measures.--
            (1) Identification.--The Secretary, in consultation 
        with the Director of the Agency for Healthcare Research 
        and Quality and the Administrator of the Centers for 
        Medicare & Medicaid Services, shall identify, not less 
        often than triennially, gaps where no quality measures 
        exist and existing quality measures that need 
        improvement, updating, or expansion, consistent with 
        the national strategy under section 399HH, to the 
        extent available, for use in Federal health programs. 
        In identifying such gaps and existing quality measures 
        that need improvement, the Secretary shall take into 
        consideration--
                    (A) the gaps identified by the entity with 
                a contract under section 1890(a) of the Social 
                Security Act and other stakeholders;
                    (B) quality measures identified by the 
                pediatric quality measures program under 
                section 1139A of the Social Security Act; and
                    (C) quality measures identified through the 
                Medicaid Quality Measurement Program under 
                section 1139B of the Social Security Act.
            (2) Publication.--The Secretary shall make 
        available to the public on an Internet website a report 
        on any gaps identified under paragraph (1) and the 
        process used to make such identification.
    (c) Grants or Contracts for Quality Measure Development.--
            (1) In general.--The Secretary shall award grants, 
        contracts, or intergovernmental agreements to eligible 
        entities for purposes of developing, improving, 
        updating, or expanding quality measures identified 
        under subsection (b).
            (2) Prioritization in the development of quality 
        measures.--In awarding grants, contracts, or agreements 
        under this subsection, the Secretary shall give 
        priority to the development of quality measures that 
        allow the assessment of--
                    (A) health outcomes and functional status 
                of patients;
                    (B) the management and coordination of 
                health care across episodes of care and care 
                transitions for patients across the continuum 
                of providers, health care settings, and health 
                plans;
                    (C) the experience, quality, and use of 
                information provided to and used by patients, 
                caregivers, and authorized representatives to 
                inform decisionmaking about treatment options, 
                including the use of shared decisionmaking 
                tools and preference sensitive care (as defined 
                in section 936);
                    (D) the meaningful use of health 
                information technology;
                    (E) the safety, effectiveness, patient-
                centeredness, appropriateness, and timeliness 
                of care;
                    (F) the efficiency of care;
                    (G) the equity of health services and 
                health disparities across health disparity 
                populations (as defined in section 485E) and 
                geographic areas;
                    (H) patient experience and satisfaction;
                    (I) the use of innovative strategies and 
                methodologies identified under section 933; and
                    (J) other areas determined appropriate by 
                the Secretary.
            (3) Eligible entities.--To be eligible for a grant 
        or contract under this subsection, an entity shall--
                    (A) have demonstrated expertise and 
                capacity in the development and evaluation of 
                quality measures;
                    (B) have adopted procedures to include in 
                the quality measure development process--
                            (i) the views of those providers or 
                        payers whose performance will be 
                        assessed by the measure; and
                            (ii) the views of other parties who 
                        also will use the quality measures 
                        (such as patients, consumers, and 
                        health care purchasers);
                    (C) collaborate with the entity with a 
                contract under section 1890(a) of the Social 
                Security Act and other stakeholders, as 
                practicable, and the Secretary so that quality 
                measures developed by the eligible entity will 
                meet the requirements to be considered for 
                endorsement by the entity with a contract under 
                such section 1890(a);
                    (D) have transparent policies regarding 
                governance and conflicts of interest; and
                    (E) submit an application to the Secretary 
                at such time and in such manner, as the 
                Secretary may require.
            (4) Use of funds.--An entity that receives a grant, 
        contract, or agreement under this subsection shall use 
        such award to develop quality measures that meet the 
        following requirements:
                    (A) Such measures support measures required 
                to be reported under the Social Security Act, 
                where applicable, and in support of gaps and 
                existing quality measures that need 
                improvement, as described in subsection 
                (b)(1)(A).
                    (B) Such measures support measures 
                developed under section 1139A of the Social 
                Security Act and the Medicaid Quality 
                Measurement Program under section 1139B of such 
                Act, where applicable.
                    (C) To the extent practicable, data on such 
                quality measures is able to be collected using 
                health information technologies.
                    (D) Each quality measure is free of charge 
                to users of such measure.
                    (E) Each quality measure is publicly 
                available on an Internet website.
    (d) Other Activities by the Secretary.--The Secretary may 
use amounts available under this section to update and test, 
where applicable, quality measures endorsed by the entity with 
a contract under section 1890(a) of the Social Security Act or 
adopted by the Secretary.
    (e) Coordination of Grants.--The Secretary shall ensure 
that grants or contracts awarded under this section are 
coordinated with grants and contracts awarded under sections 
1139A(5) and 1139B(4)(A) of the Social Security Act.
    (f) Development of Outcome Measures.--
            (1) In general.--The Secretary shall develop, and 
        periodically update (not less than every 3 years), 
        provider-level outcome measures for hospitals and 
        physicians, as well as other providers as determined 
        appropriate by the Secretary.
            (2) Categories of measures.--The measures developed 
        under this subsection shall include, to the extent 
        determined appropriate by the Secretary--
                    (A) outcome measurement for acute and 
                chronic diseases, including, to the extent 
                feasible, the 5 most prevalent and resource-
                intensive acute and chronic medical conditions; 
                and
                    (B) outcome measurement for primary and 
                preventative care, including, to the extent 
                feasible, measurements that cover provision of 
                such care for distinct patient populations 
                (such as healthy children, chronically ill 
                adults, or infirm elderly individuals).
            (3) Goals.--In developing such measures, the 
        Secretary shall seek to--
                    (A) address issues regarding risk 
                adjustment, accountability, and sample size;
                    (B) include the full scope of services that 
                comprise a cycle of care; and
                    (C) include multiple dimensions.
            (4) Timeframe.--
                    (A) Acute and chronic diseases.--Not later 
                than 24 months after the date of enactment of 
                this Act, the Secretary shall develop not less 
                than 10 measures described in paragraph (2)(A).
                    (B) Primary and preventive care.--Not later 
                than 36 months after the date of enactment of 
                this Act, the Secretary shall develop not less 
                than 10 measures described in paragraph (2)(B).

          Subpart II--Health Care Quality Improvement Programs

SEC. 933. [299B-33] HEALTH CARE DELIVERY SYSTEM RESEARCH.

    (a) Purpose.--The purposes of this section are to--
            (1) enable the Director to identify, develop, 
        evaluate, disseminate, and provide training in 
        innovative methodologies and strategies for quality 
        improvement practices in the delivery of health care 
        services that represent best practices (referred to as 
        ``best practices'') in health care quality, safety, and 
        value; and
            (2) ensure that the Director is accountable for 
        implementing a model to pursue such research in a 
        collaborative manner with other related Federal 
        agencies.
    (b) General Functions of the Center.--The Center for 
Quality Improvement and Patient Safety of the Agency for 
Healthcare Research and Quality (referred to in this section as 
the ``Center''), or any other relevant agency or department 
designated by the Director, shall--
            (1) carry out its functions using research from a 
        variety of disciplines, which may include epidemiology, 
        health services, sociology, psychology, human factors 
        engineering, biostatistics, health economics, clinical 
        research, and health informatics;
            (2) conduct or support activities consistent with 
        the purposes described in subsection (a), and for--
                    (A) best practices for quality improvement 
                practices in the delivery of health care 
                services; and
                    (B) that include changes in processes of 
                care and the redesign of systems used by 
                providers that will reliably result in intended 
                health outcomes, improve patient safety, and 
                reduce medical errors (such as skill 
                development for health care providers in team-
                based health care delivery and rapid cycle 
                process improvement) and facilitate adoption of 
                improved workflow;
            (3) identify health care providers, including 
        health care systems, single institutions, and 
        individual providers, that--
                    (A) deliver consistently high-quality, 
                efficient health care services (as determined 
                by the Secretary); and
                    (B) employ best practices that are 
                adaptable and scalable to diverse health care 
                settings or effective in improving care across 
                diverse settings;
            (4) assess research, evidence, and knowledge about 
        what strategies and methodologies are most effective in 
        improving health care delivery;
            (5) find ways to translate such information rapidly 
        and effectively into practice, and document the 
        sustainability of those improvements;
            (6) create strategies for quality improvement 
        through the development of tools, methodologies, and 
        interventions that can successfully reduce variations 
        in the delivery of health care;
            (7) identify, measure, and improve organizational, 
        human, or other causative factors, including those 
        related to the culture and system design of a health 
        care organization, that contribute to the success and 
        sustainability of specific quality improvement and 
        patient safety strategies;
            (8) provide for the development of best practices 
        in the delivery of health care services that--
                    (A) have a high likelihood of success, 
                based on structured review of empirical 
                evidence;
                    (B) are specified with sufficient detail of 
                the individual processes, steps, training, 
                skills, and knowledge required for 
                implementation and incorporation into workflow 
                of health care practitioners in a variety of 
                settings;
                    (C) are designed to be readily adapted by 
                health care providers in a variety of settings; 
                and
                    (D) where applicable, assist health care 
                providers in working with other health care 
                providers across the continuum of care and in 
                engaging patients and their families in 
                improving the care and patient health outcomes;
            (9) provide for the funding of the activities of 
        organizations with recognized expertise and excellence 
        in improving the delivery of health care services, 
        including children's health care, by involving multiple 
        disciplines, managers of health care entities, broad 
        development and training, patients, caregivers and 
        families, and frontline health care workers, including 
        activities for the examination of strategies to share 
        best quality improvement practices and to promote 
        excellence in the delivery of health care services; and
            (10) build capacity at the State and community 
        level to lead quality and safety efforts through 
        education, training, and mentoring programs to carry 
        out the activities under paragraphs (1) through (9).
    (c) Research Functions of Center.--
            (1) In general.--The Center shall support, such as 
        through a contract or other mechanism, research on 
        health care delivery system improvement and the 
        development of tools to facilitate adoption of best 
        practices that improve the quality, safety, and 
        efficiency of health care delivery services. Such 
        support may include establishing a Quality Improvement 
        Network Research Program for the purpose of testing, 
        scaling, and disseminating of interventions to improve 
        quality and efficiency in health care. Recipients of 
        funding under the Program may include national, State, 
        multi-State, or multi-site quality improvement 
        networks.
            (2) Research requirements.--The research conducted 
        pursuant to paragraph (1) shall--
                    (A) address the priorities identified by 
                the Secretary in the national strategic plan 
                established under section 399HH;
                    (B) identify areas in which evidence is 
                insufficient to identify strategies and 
                methodologies, taking into consideration areas 
                of insufficient evidence identified by the 
                entity with a contract under section 1890(a) of 
                the Social Security Act in the report required 
                under section 399JJ;
                    (C) address concerns identified by health 
                care institutions and providers and 
                communicated through the Center pursuant to 
                subsection (d);
                    (D) reduce preventable morbidity, 
                mortality, and associated costs of morbidity 
                and mortality by building capacity for patient 
                safety research;
                    (E) support the discovery of processes for 
                the reliable, safe, efficient, and responsive 
                delivery of health care, taking into account 
                discoveries from clinical research and 
                comparative effectiveness research;
                    (F) allow communication of research 
                findings and translate evidence into practice 
                recommendations that are adaptable to a variety 
                of settings, and which, as soon as practicable 
                after the establishment of the Center, shall 
                include--
                            (i) the implementation of a 
                        national application of Intensive Care 
                        Unit improvement projects relating to 
                        the adult (including geriatric), 
                        pediatric, and neonatal patient 
                        populations;
                            (ii) practical methods for 
                        addressing health care associated 
                        infections, including Methicillin-
                        Resistant Staphylococcus Aureus and 
                        Vancomycin-Resistant Entercoccus 
                        infections and other emerging 
                        infections; and
                            (iii) practical methods for 
                        reducing preventable hospital 
                        admissions and readmissions;
                    (G) expand demonstration projects for 
                improving the quality of children's health care 
                and the use of health information technology, 
                such as through Pediatric Quality Improvement 
                Collaboratives and Learning Networks, 
                consistent with provisions of section 1139A of 
                the Social Security Act for assessing and 
                improving quality, where applicable;
                    (H) identify and mitigate hazards by--
                            (i) analyzing events reported to 
                        patient safety reporting systems and 
                        patient safety organizations; and
                            (ii) using the results of such 
                        analyses to develop scientific methods 
                        of response to such events;
                    (I) include the conduct of systematic 
                reviews of existing practices that improve the 
                quality, safety, and efficiency of health care 
                delivery, as well as new research on improving 
                such practices; and
                    (J) include the examination of how to 
                measure and evaluate the progress of quality 
                and patient safety activities.
    (d) Dissemination of Research Findings.--
            (1) Public availability.--The Director shall make 
        the research findings of the Center available to the 
        public through multiple media and appropriate formats 
        to reflect the varying needs of health care providers 
        and consumers and diverse levels of health literacy.
            (2) Linkage to health information technology.--The 
        Secretary shall ensure that research findings and 
        results generated by the Center are shared with the 
        Office of the National Coordinator of Health 
        Information Technology and used to inform the 
        activities of the health information technology 
        extension program under section 3012, as well as any 
        relevant standards, certification criteria, or 
        implementation specifications.
    (e) Prioritization.--The Director shall identify and 
regularly update a list of processes or systems on which to 
focus research and dissemination activities of the Center, 
taking into account--
            (1) the cost to Federal health programs;
            (2) consumer assessment of health care experience;
            (3) provider assessment of such processes or 
        systems and opportunities to minimize distress and 
        injury to the health care workforce;
            (4) the potential impact of such processes or 
        systems on health status and function of patients, 
        including vulnerable populations including children;
            (5) the areas of insufficient evidence identified 
        under subsection (c)(2)(B); and
            (6) the evolution of meaningful use of health 
        information technology, as defined in section 3000.
    (f) Coordination.--The Center shall coordinate its 
activities with activities conducted by the Center for Medicare 
and Medicaid Innovation established under section 1115A of the 
Social Security Act.
    (g) Funding.--There is authorized to be appropriated to 
carry out this section $20,000,000 for fiscal years 2010 
through 2014.

SEC. 934. [299B-34] QUALITY IMPROVEMENT TECHNICAL ASSISTANCE AND 
                    IMPLEMENTATION.

    (a) In General.--The Director, through the Center for 
Quality Improvement and Patient Safety of the Agency for 
Healthcare Research and Quality (referred to in this section as 
the ``Center''), shall award--
            (1) technical assistance grants or contracts to 
        eligible entities to provide technical support to 
        institutions that deliver health care and health care 
        providers (including rural and urban providers of 
        services and suppliers with limited infrastructure and 
        financial resources to implement and support quality 
        improvement activities, providers of services and 
        suppliers with poor performance scores, and providers 
        of services and suppliers for which there are 
        disparities in care among subgroups of patients) so 
        that such institutions and providers understand, adapt, 
        and implement the models and practices identified in 
        the research conducted by the Center, including the 
        Quality Improvement Networks Research Program; and
            (2) implementation grants or contracts to eligible 
        entities to implement the models and practices 
        described under paragraph (1).
    (b) Eligible Entities.--
            (1) Technical assistance award.--To be eligible to 
        receive a technical assistance grant or contract under 
        subsection (a)(1), an entity--
                    (A) may be a health care provider, health 
                care provider association, professional 
                society, health care worker organization, 
                Indian health organization, quality improvement 
                organization, patient safety organization, 
                local quality improvement collaborative, the 
                Joint Commission, academic health center, 
                university, physician-based research network, 
                primary care extension program established 
                under section 399V-1, a Federal Indian Health 
                Service program or a health program operated by 
                an Indian tribe (as defined in section 4 of the 
                Indian Health Care Improvement Act), or any 
                other entity identified by the Secretary; and
                    (B) shall have demonstrated expertise in 
                providing information and technical support and 
                assistance to health care providers regarding 
                quality improvement.
            (2) Implementation award.--To be eligible to 
        receive an implementation grant or contract under 
        subsection (a)(2), an entity--
                    (A) may be a hospital or other health care 
                provider or consortium or providers, as 
                determined by the Secretary; and
                    (B) shall have demonstrated expertise in 
                providing information and technical support and 
                assistance to health care providers regarding 
                quality improvement.
    (c) Application.--
            (1) Technical assistance award.--To receive a 
        technical assistance grant or contract under subsection 
        (a)(1), an eligible entity shall submit an application 
        to the Secretary at such time, in such manner, and 
        containing--
                    (A) a plan for a sustainable business model 
                that may include a system of--
                            (i) charging fees to institutions 
                        and providers that receive technical 
                        support from the entity; and
                            (ii) reducing or eliminating such 
                        fees for such institutions and 
                        providers that serve low-income 
                        populations; and
                    (B) such other information as the Director 
                may require.
            (2) Implementation award.--To receive a grant or 
        contract under subsection (a)(2), an eligible entity 
        shall submit an application to the Secretary at such 
        time, in such manner, and containing--
                    (A) a plan for implementation of a model or 
                practice identified in the research conducted 
                by the Center including--
                            (i) financial cost, staffing 
                        requirements, and timeline for 
                        implementation; and
                            (ii) pre- and projected post-
                        implementation quality measure 
                        performance data in targeted 
                        improvement areas identified by the 
                        Secretary; and
                    (B) such other information as the Director 
                may require.
    (d) Matching Funds.--The Director may not award a grant or 
contract under this section to an entity unless the entity 
agrees that it will make available (directly or through 
contributions from other public or private entities) non-
Federal contributions toward the activities to be carried out 
under the grant or contract in an amount equal to $1 for each 
$5 of Federal funds provided under the grant or contract. Such 
non-Federal matching funds may be provided directly or through 
donations from public or private entities and may be in cash or 
in-kind, fairly evaluated, including plant, equipment, or 
services.
    (e) Evaluation.--
            (1) In general.--The Director shall evaluate the 
        performance of each entity that receives a grant or 
        contract under this section. The evaluation of an 
        entity shall include a study of--
                    (A) the success of such entity in achieving 
                the implementation, by the health care 
                institutions and providers assisted by such 
                entity, of the models and practices identified 
                in the research conducted by the Center under 
                section 933;
                    (B) the perception of the health care 
                institutions and providers assisted by such 
                entity regarding the value of the entity; and
                    (C) where practicable, better patient 
                health outcomes and lower cost resulting from 
                the assistance provided by such entity.
            (2) Effect of evaluation.--Based on the outcome of 
        the evaluation of the entity under paragraph (1), the 
        Director shall determine whether to renew a grant or 
        contract with such entity under this section.
    (f) Coordination.--The entities that receive a grant or 
contract under this section shall coordinate with health 
information technology regional extension centers under section 
3012(c) and the primary care extension program established 
under section 399V-1 regarding the dissemination of quality 
improvement, system delivery reform, and best practices 
information.

SEC. 935. [299B-35] GRANTS OR CONTRACTS TO IMPLEMENT MEDICATION 
                    MANAGEMENT SERVICES IN TREATMENT OF CHRONIC 
                    DISEASES.

    (a) In General.--The Secretary, acting through the Patient 
Safety Research Center established in section 933 (referred to 
in this section as the ``Center''), shall establish a program 
to provide grants or contracts to eligible entities to 
implement medication management (referred to in this section as 
``MTM'') services provided by licensed pharmacists, as a 
collaborative, multidisciplinary, inter-professional approach 
to the treatment of chronic diseases for targeted individuals, 
to improve the quality of care and reduce overall cost in the 
treatment of such diseases. The Secretary shall commence the 
program under this section not later than May 1, 2010.
    (b) Eligible Entities.--To be eligible to receive a grant 
or contract under subsection (a), an entity shall--
            (1) provide a setting appropriate for MTM services, 
        as recommended by the experts described in subsection 
        (e);
            (2) submit to the Secretary a plan for achieving 
        long-term financial sustainability;
            (3) where applicable, submit a plan for 
        coordinating MTM services through local community 
        health teams established in section 3502 of the Patient 
        Protection and Affordable Care Act or in collaboration 
        with primary care extension programs established in 
        section 399V-1;
            (4) submit a plan for meeting the requirements 
        under subsection (c); and
            (5) submit to the Secretary such other information 
        as the Secretary may require.
    (c) MTM Services to Targeted Individuals.--The MTM services 
provided with the assistance of a grant or contract awarded 
under subsection (a) shall, as allowed by State law including 
applicable collaborative pharmacy practice agreements, 
include--
            (1) performing or obtaining necessary assessments 
        of the health and functional status of each patient 
        receiving such MTM services;
            (2) formulating a medication treatment plan 
        according to therapeutic goals agreed upon by the 
        prescriber and the patient or caregiver or authorized 
        representative of the patient;
            (3) selecting, initiating, modifying, recommending 
        changes to, or administering medication therapy;
            (4) monitoring, which may include access to, 
        ordering, or performing laboratory assessments, and 
        evaluating the response of the patient to therapy, 
        including safety and effectiveness;
            (5) performing an initial comprehensive medication 
        review to identify, resolve, and prevent medication-
        related problems, including adverse drug events, 
        quarterly targeted medication reviews for ongoing 
        monitoring, and additional followup interventions on a 
        schedule developed collaboratively with the prescriber;
            (6) documenting the care delivered and 
        communicating essential information about such care, 
        including a summary of the medication review, and the 
        recommendations of the pharmacist to other appropriate 
        health care providers of the patient in a timely 
        fashion;
            (7) providing education and training designed to 
        enhance the understanding and appropriate use of the 
        medications by the patient, caregiver, and other 
        authorized representative;
            (8) providing information, support services, and 
        resources and strategies designed to enhance patient 
        adherence with therapeutic regimens;
            (9) coordinating and integrating MTM services 
        within the broader health care management services 
        provided to the patient; and
            (10) such other patient care services allowed under 
        pharmacist scopes of practice in use in other Federal 
        programs that have implemented MTM services.
    (d) Targeted Individuals.--MTM services provided by 
licensed pharmacists under a grant or contract awarded under 
subsection (a) shall be offered to targeted individuals who--
            (1) take 4 or more prescribed medications 
        (including over-the-counter medications and dietary 
        supplements);
            (2) take any ``high risk'' medications;
            (3) have 2 or more chronic diseases, as identified 
        by the Secretary; or
            (4) have undergone a transition of care, or other 
        factors, as determined by the Secretary, that are 
        likely to create a high risk of medication-related 
        problems.
    (e) Consultation With Experts.--In designing and 
implementing MTM services provided under grants or contracts 
awarded under subsection (a), the Secretary shall consult with 
Federal, State, private, public-private, and academic entities, 
pharmacy and pharmacist organizations, health care 
organizations, consumer advocates, chronic disease groups, and 
other stakeholders involved with the research, dissemination, 
and implementation of pharmacist-delivered MTM services, as the 
Secretary determines appropriate. The Secretary, in 
collaboration with this group, shall determine whether it is 
possible to incorporate rapid cycle process improvement 
concepts in use in other Federal programs that have implemented 
MTM services.
    (f) Reporting to the Secretary.--An entity that receives a 
grant or contract under subsection (a) shall submit to the 
Secretary a report that describes and evaluates, as requested 
by the Secretary, the activities carried out under subsection 
(c), including quality measures endorsed by the entity with a 
contract under section 1890 of the Social Security Act, as 
determined by the Secretary.
    (g) Evaluation and Report.--The Secretary shall submit to 
the relevant committees of Congress a report which shall--
            (1) assess the clinical effectiveness of 
        pharmacist-provided services under the MTM services 
        program, as compared to usual care, including an 
        evaluation of whether enrollees maintained better 
        health with fewer hospitalizations and emergency room 
        visits than similar patients not enrolled in the 
        program;
            (2) assess changes in overall health care resource 
        use by targeted individuals;
            (3) assess patient and prescriber satisfaction with 
        MTM services;
            (4) assess the impact of patient-cost sharing 
        requirements on medication adherence and 
        recommendations for modifications;
            (5) identify and evaluate other factors that may 
        impact clinical and economic outcomes, including 
        demographic characteristics, clinical characteristics, 
        and health services use of the patient, as well as 
        characteristics of the regimen, pharmacy benefit, and 
        MTM services provided; and
            (6) evaluate the extent to which participating 
        pharmacists who maintain a dispensing role have a 
        conflict of interest in the provision of MTM services, 
        and if such conflict is found, provide recommendations 
        on how such a conflict might be appropriately 
        addressed.
    (h) Grants or Contracts To Fund Development of Performance 
Measures.--The Secretary may, through the quality measure 
development program under section 931 of the Public Health 
Service Act, award grants or contracts to eligible entities for 
the purpose of funding the development of performance measures 
that assess the use and effectiveness of medication therapy 
management services.

SEC. 936. [299B-36] PROGRAM TO FACILITATE SHARED DECISIONMAKING.

    (a) Purpose.--The purpose of this section is to facilitate 
collaborative processes between patients, caregivers or 
authorized representatives, and clinicians that engages the 
patient, caregiver or authorized representative in 
decisionmaking, provides patients, caregivers or authorized 
representatives with information about trade-offs among 
treatment options, and facilitates the incorporation of patient 
preferences and values into the medical plan.
    (b) Definitions.--In this section:
            (1) Patient decision aid.--The term ``patient 
        decision aid'' means an educational tool that helps 
        patients, caregivers or authorized representatives 
        understand and communicate their beliefs and 
        preferences related to their treatment options, and to 
        decide with their health care provider what treatments 
        are best for them based on their treatment options, 
        scientific evidence, circumstances, beliefs, and 
        preferences.
            (2) Preference sensitive care.--The term 
        ``preference sensitive care'' means medical care for 
        which the clinical evidence does not clearly support 
        one treatment option such that the appropriate course 
        of treatment depends on the values of the patient or 
        the preferences of the patient, caregivers or 
        authorized representatives regarding the benefits, 
        harms and scientific evidence for each treatment 
        option, the use of such care should depend on the 
        informed patient choice among clinically appropriate 
        treatment options.
    (c) Establishment of Independent Standards for Patient 
Decision Aids for Preference Sensitive Care.--
            (1) Contract with entity to establish standards and 
        certify patient decision aids.--
                    (A) In general.--For purposes of supporting 
                consensus-based standards for patient decision 
                aids for preference sensitive care and a 
                certification process for patient decision aids 
                for use in the Federal health programs and by 
                other interested parties, the Secretary shall 
                have in effect a contract with the entity with 
                a contract under section 1890 of the Social 
                Security Act. Such contract shall provide that 
                the entity perform the duties described in 
                paragraph (2).
                    (B) Timing for first contract.--As soon as 
                practicable after the date of the enactment of 
                this section, the Secretary shall enter into 
                the first contract under subparagraph (A).
                    (C) Period of contract.--A contract under 
                subparagraph (A) shall be for a period of 18 
                months (except such contract may be renewed 
                after a subsequent bidding process).
            (2) Duties.--The following duties are described in 
        this paragraph:
                    (A) Develop and identify standards for 
                patient decision aids.--The entity shall 
                synthesize evidence and convene a broad range 
                of experts and key stakeholders to develop and 
                identify consensus-based standards to evaluate 
                patient decision aids for preference sensitive 
                care.
                    (B) Endorse patient decision aids.--The 
                entity shall review patient decision aids and 
                develop a certification process whether patient 
                decision aids meet the standards developed and 
                identified under subparagraph (A). The entity 
                shall give priority to the review and 
                certification of patient decision aids for 
                preference sensitive care.
    (d) Program To Develop, Update and Patient Decision Aids To 
Assist Health Care Providers and Patients.--
            (1) In general.--The Secretary, acting through the 
        Director, and in coordination with heads of other 
        relevant agencies, such as the Director of the Centers 
        for Disease Control and Prevention and the Director of 
        the National Institutes of Health, shall establish a 
        program to award grants or contracts--
                    (A) to develop, update, and produce patient 
                decision aids for preference sensitive care to 
                assist health care providers in educating 
                patients, caregivers, and authorized 
                representatives concerning the relative safety, 
                relative effectiveness (including possible 
                health outcomes and impact on functional 
                status), and relative cost of treatment or, 
                where appropriate, palliative care options;
                    (B) to test such materials to ensure such 
                materials are balanced and evidence based in 
                aiding health care providers and patients, 
                caregivers, and authorized representatives to 
                make informed decisions about patient care and 
                can be easily incorporated into a broad array 
                of practice settings; and
                    (C) to educate providers on the use of such 
                materials, including through academic 
                curricula.
            (2) Requirements for patient decision aids.--
        Patient decision aids developed and produced pursuant 
        to a grant or contract under paragraph (1)--
                    (A) shall be designed to engage patients, 
                caregivers, and authorized representatives in 
                informed decisionmaking with health care 
                providers;
                    (B) shall present up-to-date clinical 
                evidence about the risks and benefits of 
                treatment options in a form and manner that is 
                age-appropriate and can be adapted for 
                patients, caregivers, and authorized 
                representatives from a variety of cultural and 
                educational backgrounds to reflect the varying 
                needs of consumers and diverse levels of health 
                literacy;
                    (C) shall, where appropriate, explain why 
                there is a lack of evidence to support one 
                treatment option over another; and
                    (D) shall address health care decisions 
                across the age span, including those affecting 
                vulnerable populations including children.
            (3) Distribution.--The Director shall ensure that 
        patient decision aids produced with grants or contracts 
        under this section are available to the public.
            (4) Nonduplication of efforts.--The Director shall 
        ensure that the activities under this section of the 
        Agency and other agencies, including the Centers for 
        Disease Control and Prevention and the National 
        Institutes of Health, are free of unnecessary 
        duplication of effort.
    (e) Grants To Support Shared Decisionmaking 
Implementation.--
            (1) In general.--The Secretary shall establish a 
        program to provide for the phased-in development, 
        implementation, and evaluation of shared decisionmaking 
        using patient decision aids to meet the objective of 
        improving the understanding of patients of their 
        medical treatment options.
            (2) Shared decisionmaking resource centers.--
                    (A) In general.--The Secretary shall 
                provide grants for the establishment and 
                support of Shared Decisionmaking Resource 
                Centers (referred to in this subsection as 
                ``Centers'') to provide technical assistance to 
                providers and to develop and disseminate best 
                practices and other information to support and 
                accelerate adoption, implementation, and 
                effective use of patient decision aids and 
                shared decisionmaking by providers.
                    (B) Objectives.--The objective of a Center 
                is to enhance and promote the adoption of 
                patient decision aids and shared decisionmaking 
                through--
                            (i) providing assistance to 
                        eligible providers with the 
                        implementation and effective use of, 
                        and training on, patient decision aids; 
                        and
                            (ii) the dissemination of best 
                        practices and research on the 
                        implementation and effective use of 
                        patient decision aids.
            (3) Shared decisionmaking participation grants.--
                    (A) In general.--The Secretary shall 
                provide grants to health care providers for the 
                development and implementation of shared 
                decisionmaking techniques and to assess the use 
                of such techniques.
                    (B) Preference.--In order to facilitate the 
                use of best practices, the Secretary shall 
                provide a preference in making grants under 
                this subsection to health care providers who 
                participate in training by Shared 
                Decisionmaking Resource Centers or comparable 
                training.
                    (C) Limitation.--Funds under this paragraph 
                shall not be used to purchase or implement use 
                of patient decision aids other than those 
                certified under the process identified in 
                subsection (c).
            (4) Guidance.--The Secretary may issue guidance to 
        eligible grantees under this subsection on the use of 
        patient decision aids.
    (f) Funding.--For purposes of carrying out this section 
there are authorized to be appropriated such sums as may be 
necessary for fiscal year 2010 and each subsequent fiscal year.

SEC. 937. [299B-37] DISSEMINATION AND BUILDING CAPACITY FOR RESEARCH.

    (a) In General.--
            (1) Dissemination.--The Office of Communication and 
        Knowledge Transfer (referred to in this section as the 
        ``Office'') at the Agency for Healthcare Research and 
        Quality (or any other relevant office designated by 
        Agency for Healthcare Research and Quality), in 
        consultation with the National Institutes of Health, 
        shall broadly disseminate the research findings that 
        are published by the Patient Centered Outcomes Research 
        Institute established under section 1181(b) of the 
        Social Security Act (referred to in this section as the 
        ``Institute'') and other government-funded research 
        relevant to comparative clinical effectiveness 
        research. The Office shall create informational tools 
        that organize and disseminate research findings for 
        physicians, health care providers, patients, payers, 
        and policy makers. The Office shall also develop a 
        publicly available resource database that collects and 
        contains government-funded evidence and research from 
        public, private, not-for profit, and academic sources.
            (2) Requirements.--The Office shall provide for the 
        dissemination of the Institute's research findings and 
        government-funded research relevant to comparative 
        clinical effectiveness research to physicians, health 
        care providers, patients, vendors of health information 
        technology focused on clinical decision support, 
        appropriate professional associations, and Federal and 
        private health plans. Materials, forums, and media used 
        to disseminate the findings, informational tools, and 
        resource databases shall--
                    (A) include a description of considerations 
                for specific subpopulations, the research 
                methodology, and the limitations of the 
                research, and the names of the entities, 
                agencies, instrumentalities, and individuals 
                who conducted any research which was published 
                by the Institute; and
                    (B) not be construed as mandates, 
                guidelines, or recommendations for payment, 
                coverage, or treatment.
    (b) Incorporation of Research Findings.--The Office, in 
consultation with relevant medical and clinical associations, 
shall assist users of health information technology focused on 
clinical decision support to promote the timely incorporation 
of research findings disseminated under subsection (a) into 
clinical practices and to promote the ease of use of such 
incorporation.
    (c) Feedback.--The Office shall establish a process to 
receive feedback from physicians, health care providers, 
patients, and vendors of health information technology focused 
on clinical decision support, appropriate professional 
associations, and Federal and private health plans about the 
value of the information disseminated and the assistance 
provided under this section.
    (d) Rule of Construction.--Nothing in this section shall 
preclude the Institute from making its research findings 
publicly available as required under section 1181(d)(8) of the 
Social Security Act.
    (e) Training of Researchers.--The Agency for Health Care 
Research and Quality, in consultation with the National 
Institutes of Health, shall build capacity for comparative 
clinical effectiveness research by establishing a grant program 
that provides for the training of researchers in the methods 
used to conduct such research, including systematic reviews of 
existing research and primary research such as clinical trials. 
At a minimum, such training shall be in methods that meet the 
methodological standards adopted under section 1181(d)(9) of 
the Social Security Act.
    (f) Building Data for Research.--The Secretary shall 
provide for the coordination of relevant Federal health 
programs to build data capacity for comparative clinical 
effectiveness research, including the development and use of 
clinical registries and health outcomes research data networks, 
in order to develop and maintain a comprehensive, interoperable 
data network to collect, link, and analyze data on outcomes and 
effectiveness from multiple sources, including electronic 
health records.
    (g) Authority To Contract With the Institute.--Agencies and 
instrumentalities of the Federal Government may enter into 
agreements with the Institute, and accept and retain funds, for 
the conduct and support of research described in this part, 
provided that the research to be conducted or supported under 
such agreements is authorized under the governing statutes of 
such agencies and instrumentalities.

                       PART E--GENERAL PROVISIONS

SEC. 941. [299C] ADVISORY COUNCIL FOR HEALTHCARE RESEARCH AND QUALITY.

    (a) Establishment.--There is established an advisory 
council to be known as the National Advisory Council for 
Healthcare Research and Quality.
    (b) Duties.--
            (1) In general.--The Advisory Council shall advise 
        the Secretary and the Director with respect to 
        activities proposed or undertaken to carry out the 
        mission of the Agency under section 901(b).
            (2) Certain recommendations.--Activities of the 
        Advisory Council under paragraph (1) shall include 
        making recommendations to the Director regarding--
                    (A) priorities regarding health care 
                research, especially studies related to 
                quality, outcomes, cost and the utilization of, 
                and access to, health care services;
                    (B) the field of health care research and 
                related disciplines, especially issues related 
                to training needs, and dissemination of 
                information pertaining to health care quality; 
                and
                    (C) the appropriate role of the Agency in 
                each of these areas in light of private sector 
                activity and identification of opportunities 
                for public-private sector partnerships.
    (c) Membership.--
            (1) In general.--The Advisory Council shall, in 
        accordance with this subsection, be composed of 
        appointed members and ex officio members. All members 
        of the Advisory Council shall be voting members other 
        than the individuals designated under paragraph (3)(B) 
        as ex officio members.
            (2) Appointed members.--The Secretary shall appoint 
        to the Advisory Council 21 appropriately qualified 
        individuals. At least 17 members of the Advisory 
        Council shall be representatives of the public who are 
        not officers or employees of the United States and at 
        least 1 member who shall be a specialist in the rural 
        aspects of 1 or more of the professions or fields 
        described in subparagraphs (A) through (G). The 
        Secretary shall ensure that the appointed members of 
        the Council, as a group, are representative of 
        professions and entities concerned with, or affected 
        by, activities under this title and under section 1142 
        of the Social Security Act. Of such members--
                    (A) three shall be individuals 
                distinguished in the conduct of research, 
                demonstration projects, and evaluations with 
                respect to health care;
                    (B) three shall be individuals 
                distinguished in the fields of health care 
                quality research or health care improvement;
                    (C) three shall be individuals 
                distinguished in the practice of medicine of 
                which at least one shall be a primary care 
                practitioner;
                    (D) three shall be individuals 
                distinguished in the other health professions;
                    (E) three shall be individuals either 
                representing the private health care sector, 
                including health plans, providers, and 
                purchasers or individuals distinguished as 
                administrators of health care delivery systems;
                    (F) three shall be individuals 
                distinguished in the fields of health care 
                economics, information systems, law, ethics, 
                business, or public policy; and
                    (G) three shall be individuals representing 
                the interests of patients and consumers of 
                health care.
            (3) Ex officio members.--The Secretary shall 
        designate as ex officio members of the Advisory 
        Council--
                    (A) the Assistant Secretary for Health, the 
                Director of the National Institutes of Health, 
                the Director of the Centers for Disease Control 
                and Prevention, the Administrator of the 
                Centers for Medicare & Medicaid Services, the 
                Commissioner of the Food and Drug 
                Administration, the Director of the Office of 
                Personnel Management, the Assistant Secretary 
                of Defense (Health Affairs), and the Under 
                Secretary for Health of the Department of 
                Veterans Affairs; and
                    (B) such other Federal officials as the 
                Secretary may consider appropriate.
    (d) Terms.--
            (1) In general.--Members of the Advisory Council 
        appointed under subsection (c)(2) shall serve for a 
        term of 3 years.
            (2) Staggered terms.--To ensure the staggered 
        rotation of one-third of the members of the Advisory 
        Council each year, the Secretary is authorized to 
        appoint the initial members of the Advisory Council for 
        terms of 1, 2, or 3 years.
            (3) Service beyond term.--A member of the Council 
        appointed under subsection (c)(2) may continue to serve 
        after the expiration of the term of the members until a 
        successor is appointed.
    (e) Vacancies.--If a member of the Advisory Council 
appointed under subsection (c)(2) does not serve the full term 
applicable under subsection (d), the individual appointed to 
fill the resulting vacancy shall be appointed for the remainder 
of the term of the predecessor of the individual.
    (f) Chair.--The Director shall, from among the members of 
the Advisory Council appointed under subsection (c)(2), 
designate an individual to serve as the chair of the Advisory 
Council.
    (g) Meetings.--The Advisory Council shall meet not less 
than once during each discrete 4-month period and shall 
otherwise meet at the call of the Director or the chair.
    (h) Compensation and Reimbursement of Expenses.--
            (1) Appointed members.--Members of the Advisory 
        Council appointed under subsection (c)(2) shall receive 
        compensation for each day (including travel time) 
        engaged in carrying out the duties of the Advisory 
        Council unless declined by the member. Such 
        compensation may not be in an amount in excess of the 
        daily equivalent of the annual rate of basic pay 
        prescribed for level IV of the Executive Schedule under 
        section 5315 of title 5, United States Code, for each 
        day during which such member is engaged in the 
        performance of the duties of the Advisory Council.
            (2) Ex officio members.--Officials designated under 
        subsection (c)(3) as ex officio members of the Advisory 
        Council may not receive compensation for service on the 
        Advisory Council in addition to the compensation 
        otherwise received for duties carried out as officers 
        of the United States.
    (i) Staff.--The Director shall provide to the Advisory 
Council such staff, information, and other assistance as may be 
necessary to carry out the duties of the Council.
    (j) Duration.--Notwithstanding section 14(a) of the Federal 
Advisory Committee Act, the Advisory Council shall continue in 
existence until otherwise provided by law.

SEC. 942. [299C-1] PEER REVIEW WITH RESPECT TO GRANTS AND CONTRACTS.

    (a) Requirement of Review.--
            (1) In general.--Appropriate technical and 
        scientific peer review shall be conducted with respect 
        to each application for a grant, cooperative agreement, 
        or contract under this title.
            (2) Reports to director.--Each peer review group to 
        which an application is submitted pursuant to paragraph 
        (1) shall report its finding and recommendations 
        respecting the application to the Director in such form 
        and in such manner as the Director shall require.
    (b) Approval as Precondition of Awards.--The Director may 
not approve an application described in subsection (a)(1) 
unless the application is recommended for approval by a peer 
review group established under subsection (c).
    (c) Establishment of Peer Review Groups.--
            (1) In general.--The Director shall establish such 
        technical and scientific peer review groups as may be 
        necessary to carry out this section. Such groups shall 
        be established without regard to the provisions of 
        title 5, United States Code, that govern appointments 
        in the competitive service, and without regard to the 
        provisions of chapter 51, and subchapter III of chapter 
        53, of such title that relate to classification and pay 
        rates under the General Schedule.
            (2) Membership.--The members of any peer review 
        group established under this section shall be appointed 
        from among individuals who by virtue of their training 
        or experience are eminently qualified to carry out the 
        duties of such peer review group. Officers and 
        employees of the United States may not constitute more 
        than 25 percent of the membership of any such group. 
        Such officers and employees may not receive 
        compensation for service on such groups in addition to 
        the compensation otherwise received for these duties 
        carried out as such officers and employees.
            (3) Duration.--Notwithstanding section 14(a) of the 
        Federal Advisory Committee Act, peer review groups 
        established under this section may continue in 
        existence until otherwise provided by law.
            (4) Qualifications.--Members of any peer review 
        group shall, at a minimum, meet the following 
        requirements:
                    (A) Such members shall agree in writing to 
                treat information received, pursuant to their 
                work for the group, as confidential 
                information, except that this subparagraph 
                shall not apply to public records and public 
                information.
                    (B) Such members shall agree in writing to 
                recuse themselves from participation in the 
                peer review of specific applications which 
                present a potential personal conflict of 
                interest or appearance of such conflict, 
                including employment in a directly affected 
                organization, stock ownership, or any financial 
                or other arrangement that might introduce bias 
                in the process of peer review.
    (d) Authority for Procedural Adjustments in Certain 
Cases.--In the case of applications for financial assistance 
whose direct costs will not exceed $100,000, the Director may 
make appropriate adjustments in the procedures otherwise 
established by the Director for the conduct of peer review 
under this section. Such adjustments may be made for the 
purpose of encouraging the entry of individuals into the field 
of research, for the purpose of encouraging clinical practice-
oriented or provider-based research, and for such other 
purposes as the Director may determine to be appropriate.
    (e) Regulations.--The Director shall issue regulations for 
the conduct of peer review under this section.

SEC. 943. [299C-2] CERTAIN PROVISIONS WITH RESPECT TO DEVELOPMENT, 
                    COLLECTION, AND DISSEMINATION OF DATA.

    (a) Standards With Respect to Utility of Data.--
            (1) In general.--To ensure the utility, accuracy, 
        and sufficiency of data collected by or for the Agency 
        for the purpose described in section 901(b), the 
        Director shall establish standard methods for 
        developing and collecting such data, taking into 
        consideration--
                    (A) other Federal health data collection 
                standards; and
                    (B) the differences between types of health 
                care plans, delivery systems, health care 
                providers, and provider arrangements.
            (2) Relationship with other department programs.--
        In any case where standards under paragraph (1) may 
        affect the administration of other programs carried out 
        by the Department of Health and Human Services, 
        including the programs under title XVIII, XIX or XXI of 
        the Social Security Act, or may affect health 
        information that is subject to a standard developed 
        under part C of title XI of the Social Security Act, 
        they shall be in the form of recommendations to the 
        Secretary for such program.
    (b) Statistics and Analyses.--The Director shall--
            (1) take appropriate action to ensure that 
        statistics and analyses developed under this title are 
        of high quality, timely, and duly comprehensive, and 
        that the statistics are specific, standardized, and 
        adequately analyzed and indexed; and
            (2) publish, make available, and disseminate such 
        statistics and analyses on as wide a basis as is 
        practicable.
    (c) Authority Regarding Certain Requests.--Upon request of 
a public or private entity, the Director may conduct or support 
research or analyses otherwise authorized by this title 
pursuant to arrangements under which such entity will pay the 
cost of the services provided. Amounts received by the Director 
under such arrangements shall be available to the Director for 
obligation until expended.

SEC. 944. [299C-3] DISSEMINATION OF INFORMATION.

    (a) In General.--The Director shall--
            (1) without regard to section 501 of title 44, 
        United States Code, promptly publish, make available, 
        and otherwise disseminate, in a form understandable and 
        on as broad a basis as practicable so as to maximize 
        its use, the results of research, demonstration 
        projects, and evaluations conducted or supported under 
        this title;
            (2) ensure that information disseminated by the 
        Agency is science-based and objective and undertakes 
        consultation as necessary to assess the appropriateness 
        and usefulness of the presentation of information that 
        is targeted to specific audiences;
            (3) promptly make available to the public data 
        developed in such research, demonstration projects, and 
        evaluations;
            (4) provide, in collaboration with the National 
        Library of Medicine where appropriate, indexing, 
        abstracting, translating, publishing, and other 
        services leading to a more effective and timely 
        dissemination of information on research, demonstration 
        projects, and evaluations with respect to health care 
        to public and private entities and individuals engaged 
        in the improvement of health care delivery and the 
        general public, and undertake programs to develop new 
        or improved methods for making such information 
        available; and
            (5) as appropriate, provide technical assistance to 
        State and local government and health agencies and 
        conduct liaison activities to such agencies to foster 
        dissemination.
    (b) Prohibition Against Restrictions.--Except as provided 
in subsection (c), the Director may not restrict the 
publication or dissemination of data from, or the results of, 
projects conducted or supported under this title.
    (c) Limitation on Use of Certain Information.--No 
information, if an establishment or person supplying the 
information or described in it is identifiable, obtained in the 
course of activities undertaken or supported under this title 
may be used for any purpose other than the purpose for which it 
was supplied unless such establishment or person has consented 
(as determined under regulations of the Director) to its use 
for such other purpose. Such information may not be published 
or released in other form if the person who supplied the 
information or who is described in it is identifiable unless 
such person has consented (as determined under regulations of 
the Director) to its publication or release in other form.
    (d) Penalty.--Any person who violates subsection (c) shall 
be subject to a civil monetary penalty of not more than $10,000 
for each such violation involved. Such penalty shall be imposed 
and collected in the same manner as civil money penalties under 
subsection (a) of section 1128A of the Social Security Act are 
imposed and collected.

SEC. 945. [299C-4] ADDITIONAL PROVISIONS WITH RESPECT TO GRANTS AND 
                    CONTRACTS.

    (a) Financial Conflicts of Interest.--With respect to 
projects for which awards of grants, cooperative agreements, or 
contracts are authorized to be made under this title, the 
Director shall by regulation define--
            (1) the specific circumstances that constitute 
        financial interests in such projects that will, or may 
        be reasonably expected to, create a bias in favor of 
        obtaining results in the projects that are consistent 
        with such interests; and
            (2) the actions that will be taken by the Director 
        in response to any such interests identified by the 
        Director.
    (b) Requirement of Application.--The Director may not, with 
respect to any program under this title authorizing the 
provision of grants, cooperative agreements, or contracts, 
provide any such financial assistance unless an application for 
the assistance is submitted to the Secretary and the 
application is in such form, is made in such manner, and 
contains such agreements, assurances, and information as the 
Director determines to be necessary to carry out the program 
involved.
    (c) Provision of Supplies and Services in Lieu of Funds.--
            (1) In general.--Upon the request of an entity 
        receiving a grant, cooperative agreement, or contract 
        under this title, the Secretary may, subject to 
        paragraph (2), provide supplies, equipment, and 
        services for the purpose of aiding the entity in 
        carrying out the project involved and, for such 
        purpose, may detail to the entity any officer or 
        employee of the Department of Health and Human 
        Services.
            (2) Corresponding reduction in funds.--With respect 
        to a request described in paragraph (1), the Secretary 
        shall reduce the amount of the financial assistance 
        involved by an amount equal to the costs of detailing 
        personnel and the fair market value of any supplies, 
        equipment, or services provided by the Director. The 
        Secretary shall, for the payment of expenses incurred 
        in complying with such request, expend the amounts 
        withheld.
    (d) Applicability of Certain Provisions With Respect to 
Contracts.--Contracts may be entered into under this part 
without regard to sections 3648 and 3709 of the Revised 
Statutes (31 U.S.C. 529 and 41 U.S.C. 5).

SEC. 946. [299C-5] CERTAIN ADMINISTRATIVE AUTHORITIES.

    (a) Deputy Director and Other Officers and Employees.--
            (1) Deputy director.--The Director may appoint a 
        deputy director for the Agency.
            (2) Other officers and employees.--The Director may 
        appoint and fix the compensation of such officers and 
        employees as may be necessary to carry out this title. 
        Except as otherwise provided by law, such officers and 
        employees shall be appointed in accordance with the 
        civil service laws and their compensation fixed in 
        accordance with title 5, United States Code.
    (b) Facilities.--The Secretary, in carrying out this 
title--
            (1) may acquire, without regard to the Act of March 
        3, 1877 (40 U.S.C. 34), by lease or otherwise through 
        the Administrator of General Services, buildings or 
        portions of buildings in the District of Columbia or 
        communities located adjacent to the District of 
        Columbia for use for a period not to exceed 10 years; 
        and
            (2) may acquire, construct, improve, repair, 
        operate, and maintain laboratory, research, and other 
        necessary facilities and equipment, and such other real 
        or personal property (including patents) as the 
        Secretary deems necessary.
    (c) Provision of Financial Assistance.--The Director, in 
carrying out this title, may make grants to public and 
nonprofit entities and individuals, and may enter into 
cooperative agreements or contracts with public and private 
entities and individuals.
    (d) Utilization of Certain Personnel and Resources.--
            (1) Department of health and human services.--The 
        Director, in carrying out this title, may utilize 
        personnel and equipment, facilities, and other physical 
        resources of the Department of Health and Human 
        Services, permit appropriate (as determined by the 
        Secretary) entities and individuals to utilize the 
        physical resources of such Department, and provide 
        technical assistance and advice.
            (2) Other agencies.--The Director, in carrying out 
        this title, may use, with their consent, the services, 
        equipment, personnel, information, and facilities of 
        other Federal, State, or local public agencies, or of 
        any foreign government, with or without reimbursement 
        of such agencies.
    (e) Consultants.--The Secretary, in carrying out this 
title, may secure, from time to time and for such periods as 
the Director deems advisable but in accordance with section 
3109 of title 5, United States Code, the assistance and advice 
of consultants from the United States or abroad.
    (f) Experts.--
            (1) In general.--The Secretary may, in carrying out 
        this title, obtain the services of not more than 50 
        experts or consultants who have appropriate scientific 
        or professional qualifications. Such experts or 
        consultants shall be obtained in accordance with 
        section 3109 of title 5, United States Code, except 
        that the limitation in such section on the duration of 
        service shall not apply.
            (2) Travel expenses.--
                    (A) In general.--Experts and consultants 
                whose services are obtained under paragraph (1) 
                shall be paid or reimbursed for their expenses 
                associated with traveling to and from their 
                assignment location in accordance with sections 
                5724, 5724a(a), 5724a(c), and 5726(c) of title 
                5, United States Code.
                    (B) Limitation.--Expenses specified in 
                subparagraph (A) may not be allowed in 
                connection with the assignment of an expert or 
                consultant whose services are obtained under 
                paragraph (1) unless and until the expert 
                agrees in writing to complete the entire period 
                of assignment, or 1 year, whichever is shorter, 
                unless separated or reassigned for reasons that 
                are beyond the control of the expert or 
                consultant and that are acceptable to the 
                Secretary. If the expert or consultant violates 
                the agreement, the money spent by the United 
                States for the expenses specified in 
                subparagraph (A) is recoverable from the expert 
                or consultant as a statutory obligation owed to 
                the United States. The Secretary may waive in 
                whole or in part a right of recovery under this 
                subparagraph.
    (g) Voluntary and Uncompensated Services.--The Director, in 
carrying out this title, may accept voluntary and uncompensated 
services.

SEC. 947. [299C-6] FUNDING.

    (a) Intent.--To ensure that the United States investment in 
biomedical research is rapidly translated into improvements in 
the quality of patient care, there must be a corresponding 
investment in research on the most effective clinical and 
organizational strategies for use of these findings in daily 
practice. The authorization levels in subsections (b) and (c) 
provide for a proportionate increase in health care research as 
the United States investment in biomedical research increases.
    (b) Authorization of Appropriations.--For the purpose of 
carrying out this title, there are authorized to be 
appropriated $250,000,000 for fiscal year 2000, and such sums 
as may be necessary for each of the fiscal years 2001 through 
2005.
    (c) Evaluations.--In addition to amounts available pursuant 
to subsection (b) for carrying out this title, there shall be 
made available for such purpose, from the amounts made 
available pursuant to section 241 (relating to evaluations), an 
amount equal to 40 percent of the maximum amount authorized in 
such section 241 to be made available for a fiscal year.
    (d) Health Disparities Research.--For the purpose of 
carrying out the activities under section 903, there are 
authorized to be appropriated $50,000,000 for fiscal year 2001, 
and such sums as may be necessary for each of the fiscal years 
2002 through 2005.
    (e) Patient Safety and Quality Improvement.--For the 
purpose of carrying out part C, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2006 through 2010.

SEC. 948. [299C-7] DEFINITIONS.

    In this title:
            (1) Advisory council.--The term ``Advisory 
        Council'' means the National Advisory Council on 
        Healthcare Research and Quality established under 
        section 941.
            (2) Agency.--The term ``Agency'' means the Agency 
        for Healthcare Research and Quality.
            (3) Director.--The term ``Director'' means the 
        Director of the Agency for Healthcare Research and 
        Quality.
  TITLE X--POPULATION RESEARCH AND VOLUNTARY FAMILY PLANNING PROGRAMS

       project grants and contracts for family planning services

    Sec. 1001. [300] (a) The Secretary is authorized to make 
grants to and enter into contracts with public or nonprofit 
private entities to assist in the establishment and operation 
of voluntary family planning projects which shall offer a broad 
range of acceptable and effective family planning methods and 
services (including natural family planning methods, 
infertility services, and services for adolescents). To the 
extent practicable, entities which receive grants or contracts 
under this subsection shall encourage familiy \1\ participation 
in projects assisted under this subsection.
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    \1\ So in law. See section 931(b)(1) of Public Law 97-35 (95 Stat. 
570). Probably should be ``family''.
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    (b) In making grants and contracts under this section the 
Secretary shall take into account the number of patients to be 
served, the extent to which family planning services are needed 
locally, the relative need of the applicant, and its capacity 
to make rapid and effective use of such assistance. Local and 
regional entities shall be assured the right to apply for 
direct grants and contracts under this section, and the 
Secretary shall by regulation fully provide for and protect 
such right.
    (c) The Secretary, at the request of a recipient of a grant 
under subsection (a), may reduce the amount of such grant by 
the fair market value of any supplies or equipment furnished 
the grant recipient by the Secretary. The amount by which any 
such grant is so reduced shall be available for payment by the 
Secretary of the costs incurred in furnishing the supplies or 
equipment on which the reduction of such grant is based. Such 
amount shall be deemed as part of the grant and shall be deemed 
to have been paid to the grant recipient.
    (d) For the purpose of making grants and contracts under 
this section, there are authorized to be appropriated 
$30,000,000 for the fiscal year ending June 30, 1971; 
$60,000,000 for the fiscal year ending June 30, 1972; 
$111,500,000 for the fiscal year ending June 30, 1973; 
$111,500,000 each for the fiscal years ending June 30, 1974, 
and June 30, 1975; $115,000,000 for fiscal year 1976; 
$115,000,000 for the fiscal year ending September 30, 1977; 
$136,400,000 for the fiscal year ending September 30, 1978; 
$200,000,000 for the fiscal year ending September 30, 1979; 
$230,000,000 for the fiscal year ending September 30, 1980; 
$264,500,000 for the fiscal year ending September 30, 1981; 
$126,510,000 for the fiscal year ending September 30, 1982; 
$139,200,000 for the fiscal year ending September 30, 1983; 
$150,030,000 for the fiscal year ending September 30, 1984; and 
$158,400,000 for the fiscal year ending September 30, 1985.

         formula grants to states for family planning services

    Sec. 1002. [300a] (a) The Secretary is authorized to make 
grants, from allotments made under subsection (b), to State 
health authorities to assist in planning, establishing, 
maintaining, coordinating, and evaluating family planning 
services. No grant may be made to a State health authority 
under this section unless such authority has submitted, and had 
approved by the Secretary, a State plan for a coordinated and 
comprehensive program of family planning services.
    (b) The sums appropriated to carry out the provisions of 
this section shall be allotted to the States by the Secretary 
on the basis of the population and the financial need of the 
respective States.
    (c) For the purposes of this section, the term ``State'' 
includes the Commonwealth of Puerto Rico, the Northern Mariana 
Islands, Guam, American Samoa, the Virgin Islands, the District 
of Columbia, and the Trust Territory of the Pacific Islands.
    (d) For the purpose of making grants under this section, 
there are authorized to be appropriated $10,000,000 for the 
fiscal year ending June 30, 1971; $15,000,000 for the fiscal 
year ending June 30, 1972; and $20,000,000 for the fiscal year 
ending June 30, 1973.

                     training grants and contracts

    Sec. 1003. [300a-1] (a) The Secretary is authorized to make 
grants to public or nonprofit private entities and to enter 
into contracts with public or private entities and individuals 
to provide the training for personnel to carry out family 
planning service programs described in section 1001 or 1002.
    (b) For the purpose of making payments pursuant to grants 
and contracts under this section, there are authorized to be 
appropriated $2,000,000 for the fiscal year ending June 30, 
1971; $3,000,000 for the fiscal year ending June 30, 1972; 
$4,000,000 for the fiscal year ending June 30, 1973; and 
$3,000,000 each for the fiscal years ending June 30, 1974, and 
June 30, 1975; $4,000,000 for fiscal year 1976; $5,000,000 for 
the fiscal year ending September 30, 1977; $3,000,000 for the 
fiscal year ending September 30, 1978; $3,100,000 for the 
fiscal year ending September 30, 1979; $3,600,000 for the 
fiscal year ending September 30, 1980; $4,100,000 for the 
fiscal year ending September 30, 1981; $2,920,000 for the 
fiscal year ending September 30, 1982; $3,200,000 for the 
fiscal year ending September 30, 1983; $3,500,000 for the 
fiscal year ending September 30, 1984; and $3,500,000 for the 
fiscal year ending September 30, 1985.

                                research

    Sec. 1004. [300a-2] The Secretary may--
            (1) conduct, and
            (2) make grants to public or nonprofit private 
        entities and enter into contracts with public or 
        private entities and individuals for projects for,
research in the biomedical, contraceptive development, 
behavioral, and program implementation fields related to family 
planning and population.

                informational and educational materials

    Sec. 1005. [300a-3] (a) The Secretary is authorized to make 
grants to public or nonprofit private entities and to enter 
into contracts with public or private entities and individuals 
to assist in developing and making available family planning 
and population growth information (including educational 
materials) to all persons desiring such information (or 
materials).
    (b) For the purpose of making payments pursuant to grants 
and contracts under this section, there are authorized to be 
appropriated $750,000 for the fiscal year ending June 30, 1971; 
$1,000,000 for the fiscal year ending June 30, 1972; $1,250,000 
for the fiscal year ending June 30, 1973; $909,000 each for the 
fiscal years ending June 30, 1974, and June 30, 1975; 
$2,000,000 for fiscal year 1976; $2,500,000 for the fiscal year 
ending September 30, 1977; $600,000 for the fiscal year ending 
September 30, 1978; $700,000 for the fiscal year ending 
September 30, 1979; $805,000 for the fiscal year ending 
September 30, 1980; $926,000 for the fiscal year ending 
September 30, 1981; $570,000 for the fiscal year ending 
September 30, 1982; $600,000 for the fiscal year ending 
September 30, 1983; $670,000 for the fiscal year ending 
September 30, 1984; and $700,000 for the fiscal year ending 
September 30, 1985.

                        regulations and payments

    Sec. 1006. [300a-4] (a) Grants and contracts made under 
this title shall be made in accordance with such regulations as 
the Secretary may promulgate. The amount of any grant under any 
section of this title shall be determined by the Secretary; 
except that no grant under any such section for any program or 
project for a fiscal year beginning after June 30, 1975, may be 
made for less than 90 per centum of its costs (as determined 
under regulations of the Secretary) unless the grant is to be 
made for a program or project for which a grant was made (under 
the same section) for the fiscal year ending June 30, 1975, for 
less than 90 per centum of its costs (as so determined), in 
which case a grant under such section for that program or 
project for a fiscal year beginning after that date may be made 
for a percentage which shall not be less than the percentage of 
its costs for which the fiscal year 1975 grant was made.
    (b) Grants under this title shall be payable in such 
installments and subject to such conditions as the Secretary 
may determine to be appropriate to assure that such grants will 
be effectively utilized for the purposes for which made.
    (c) A grant may be made or contract entered into under 
section 1001 or 1002 for a family planning service project or 
program only upon assurances satisfactory to the Secretary 
that--
            (1) priority will be given in such project or 
        program to the furnishing of such services to persons 
        from low-income families; and
            (2) no charge will be made in such project or 
        program for services provided to any person from a low-
        income family except to the extent that payment will be 
        made by a third party (including a government agency) 
        which is authorized or is under legal obligation to pay 
        such charge.
For purposes of this subsection, the term ``low-income family'' 
shall be defined by the Secretary in accordance with such 
criteria as he may prescribe so as to insure that economic 
status shall not be a deterrent to participation in the 
programs assisted under this title.
    (d)(1) A grant may be made or a contract entered into under 
section 1001 or 1005 only upon assurances satisfactory to the 
Secretary that informational or educational materials developed 
or made available under the grant or contract will be suitable 
for the purposes of this title and for the population or 
community to which they are to be made available, taking into 
account the educational and cultural background of the 
individuals to whom such materials are addressed and the 
standards of such population or community with respect to such 
materials.
    (2) In the case of any grant or contract under section 
1001, such assurances shall provide for the review and approval 
of the suitability of such materials, prior to their 
distribution, by an advisory committee established by the 
grantee or contractor in accordance with the Secretary's 
regulations. Such a committee shall include individuals broadly 
representative of the population or community to which the 
materials are to be made available.

                        voluntary participation

    Sec. 1007. [300a-5] The acceptance by any individual of 
family planning services or family planning or population 
growth information (including educational materials) provided 
through financial assistance under this title (whether by grant 
or contract) shall be voluntary and shall not be a prerequisite 
to eligibility for or receipt of any other service or 
assistance from, or to participation in, any other program of 
the entity or individual that provided such service or 
information.

                        prohibition of abortion

    Sec. 1008. \1\ [300a-6] None of the funds appropriated 
under this title shall be used in programs where abortion is a 
method of family planning.
---------------------------------------------------------------------------
    \1\ Section 1009 was repealed by section 601(a)(1)(G) of Public Law 
105-362 (112 Stat. 3285).
  TITLE XI--GENETIC DISEASES, HEMOPHILIA PROGRAMS, AND SUDDEN INFANT 
                             DEATH SYNDROME

                        Part A--Genetic Diseases

                 research project grants and contracts

    Sec. 1102. [300b-1] In carrying out section 301, the 
Secretary, may make grants to public and nonprofit private 
entities, and may enter into contracts with public and private 
entities and individuals, for projects for (1) basic or applied 
research leading to the understanding, diagnosis, treatment, 
and control of genetic diseases, (2) planning, establishing, 
demonstrating, and developing special programs for the training 
of genetic counselors, social and behavioral scientists, and 
other health professionals, (3) the development of programs to 
educate practicing physicians, other health professionals and 
the public regarding the nature of genetic processes, the 
inheritance patterns of genetic diseases, and the means, 
methods, and facilities available to diagnose, control, 
counsel, and treat genetic diseases, and (4) the development of 
counseling and testing programs and other programs for the 
diagnosis, control, and treatment of genetic diseases. In 
making grants and entering into contracts for projects 
described in clause (1) of the preceding sentence, the 
Secretary shall give priority to applications for such grants 
or contracts which are submitted for research on sickle cell 
anemia and for research on Cooley's anemia.

                        voluntary participation

    Sec. 1103. [300b-2] The participation by any individual in 
any program or portion thereof under this part shall be wholly 
voluntary and shall not be a prerequisite to eligibility for or 
receipt of any other service or assistance from, or to 
participation in, any other program.

      application; administration of grants and contract programs

    Sec. 1104. [300b-3] (a) A grant or contract under this part 
may be made upon application submitted to the Secretary at such 
time, in such manner, and containing and accompanied by such 
information, as the Secretary may require including assurances 
for an evaluation whether performed by the applicant or by the 
Secretary. Such grant or contract may be made available on less 
than a state-wide or regional basis. Each applicant shall--
            (1) provide that the programs and activities for 
        which assistance under this part is sought will be 
        administered by or under the supervision of the 
        applicant;
            (2) provide for strict confidentiality of all test 
        results, medical records, and other information 
        regarding testing, diagnosis, counseling, or treatment 
        of any person treated, except for (A) such information 
        as the patient (or his guardian) gives informed consent 
        to be released, or (B) statistical data compiled 
        without reference to the identity of any such patient;
            (3) provide for community representation where 
        appropriate in the development and operation of 
        voluntary genetic testing or counseling programs funded 
        by a grant or contract under this part; and
            (4) establish fiscal control and fund accounting 
        procedures as may be necessary to assure proper 
        disbursement of and accounting of Federal funds paid to 
        the applicant under this part.
    (b) In making grants and entering into contracts for any 
fiscal year under section 301 for projects described in section 
1102 the Secretary shall give special consideration to 
applications from entities that received grants from, or 
entered into contracts with, the Secretary for the preceding 
fiscal year for the conduct of comprehensive sickle cell 
centers or sickle cell screening and education clinics.

                    public health service facilities

    Sec. 1105. [300b-4] The Secretary shall establish a program 
within the Service to provide voluntary testing, diagnosis, 
counseling, and treatment of individuals respecting genetic 
diseases. Services under such program shall be made available 
through facilities of the Service to persons requesting such 
services, and the program shall provide appropriate publicity 
of the availability and voluntary nature of such services.

    Sec. 1106. [Repealed].

                           applied technology

    Sec. 1107. [300b-6] The Secretary, acting through an 
identifiable administrative unit, shall--
            (1) conduct epidemiological assessments and 
        surveillance of genetic diseases to define the scope 
        and extent of such diseases and the need for programs 
        for the diagnosis, treatment, and control of such 
        diseases, screening for such diseases, and the 
        counseling of persons with such diseases;
            (2) on the basis of the assessments and 
        surveillance described in paragraph (1), develop for 
        use by the States programs which combine in an 
        effective manner diagnosis, treatment, and control of 
        such diseases, screening for such diseases, and 
        counseling of persons with such diseases; and
            (3) on the basis of the assessments and 
        surveillance described in paragraph (1), provide 
        technical assistance to States to implement the 
        programs developed under paragraph (2) and train 
        appropriate personnel for such programs.
In carrying out this section, the Secretary may, from funds 
allotted for use under section 502(a) of the Social Security 
Act, make grants to or contracts with public or nonprofit 
private entities (including grants and contracts for 
demonstration projects).
                           tourette syndrome
    Sec. 1108. [300b-7] (a) In General.--The Secretary shall 
develop and implement outreach programs to educate the public, 
health care providers, educators and community based 
organizations about the etiology, symptoms, diagnosis and 
treatment of Tourette Syndrome, with a particular emphasis on 
children with Tourette Syndrome. Such programs may be carried 
out by the Secretary directly and through awards of grants or 
contracts to public or nonprofit private entities.
    (b) Certain Activities.--Activities under subsection (a) 
shall include--
            (1) the production and translation of educational 
        materials, including public service announcements;
            (2) the development of training material for health 
        care providers, educators and community based 
        organizations; and
            (3) outreach efforts directed at the misdiagnosis 
        and underdiagnosis of Tourette Syndrome in children and 
        in minority groups.
    (c) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2001 through 2005.

SEC. 1109. [300B-8] IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE 
                    DISORDERS.

    (a) Authorization of Grant Program.--From amounts 
appropriated under subsection (j), the Secretary, acting 
through the Administrator of the Health Resources and Services 
Administration (referred to in this section as the 
``Administrator'') and in consultation with the Advisory 
Committee on Heritable Disorders in Newborns and Children 
(referred to in this section as the ``Advisory Committee''), 
shall award grants to eligible entities to enable such 
entities--
            (1) to enhance, improve or expand the ability of 
        State and local public health agencies to provide 
        screening, counseling, or health care services to 
        newborns and children having or at risk for heritable 
        disorders;
            (2) to assist in providing health care 
        professionals and newborn screening laboratory 
        personnel with education in newborn screening and 
        training in relevant and new technologies in newborn 
        screening and congenital, genetic, and metabolic 
        disorders;
            (3) to develop and deliver educational programs (at 
        appropriate literacy levels) about newborn screening 
        counseling, testing, follow-up, treatment, and 
        specialty services to parents, families, and patient 
        advocacy and support groups; and
            (4) to establish, maintain, and operate a system to 
        assess and coordinate treatment relating to congenital, 
        genetic, and metabolic disorders.
    (b) Eligible Entity.--In this section, the term ``eligible 
entity'' means--
            (1) a State or a political subdivision of a State;
            (2) a consortium of 2 or more States or political 
        subdivisions of States;
            (3) a territory;
            (4) a health facility or program operated by or 
        pursuant to a contract with or grant from the Indian 
        Health Service; or
            (5) any other entity with appropriate expertise in 
        newborn screening, as determined by the Secretary.
    (c) Approval Factors.--An application submitted for a grant 
under subsection (a)(1) shall not be approved by the Secretary 
unless the application contains assurances that the eligible 
entity has adopted and implemented, is in the process of 
adopting and implementing, or will use amounts received under 
such grant to adopt and implement the guidelines and 
recommendations of the Advisory Committee that are adopted by 
the Secretary and in effect at the time the grant is awarded or 
renewed under this section, which shall include the screening 
of each newborn for the heritable disorders recommended by the 
Advisory Committee and adopted by the Secretary.
    (d) Coordination.--The Secretary shall take all necessary 
steps to coordinate programs funded with grants received under 
this section and to coordinate with existing newborn screening 
activities.
    (e) Limitation.--An eligible entity may not use amounts 
received under this section to--
            (1) provide cash payments to or on behalf of 
        affected individuals;
            (2) provide inpatient services;
            (3) purchase land or make capital improvements to 
        property; or
            (4) provide for proprietary research or training.
    (f ) Voluntary Participation.--The participation by any 
individual in any program or portion thereof established or 
operated with funds received under this section shall be wholly 
voluntary and shall not be a prerequisite to eligibility for or 
receipt of any other service or assistance from, or to 
participation in, another Federal or State program.
    (g) Supplement Not Supplant.--Funds appropriated under this 
section shall be used to supplement and not supplant other 
Federal, State, and local public funds provided for activities 
of the type described in this section.
    (h) Publication.--
            (1) In general.--An application submitted under 
        subsection (c)(2) \1\ shall be made public by the State 
        in such a manner as to facilitate comment from any 
        person, including through hearings and other methods 
        used to facilitate comments from the public.
---------------------------------------------------------------------------
    \1\ Subsection (c)(2) was stricken by section 2(1) of the Newborn 
Screening Saves Lives Act of 2007 (Public Law 110-204).
---------------------------------------------------------------------------
            (2) Comments.--Comments received by the State after 
        the publication described in paragraph (1) shall be 
        addressed in the application submitted under subsection 
        (c)(2) \1\.
    (i) Technical Assistance.--The Secretary shall provide to 
entities receiving grants under subsection (a) such technical 
assistance as may be necessary to ensure the quality of 
programs conducted under this section.
    (j) Authorization of Appropriations.--There are authorized 
to be appropriated--
            (1) to provide grants for the purpose of carrying 
        out activities under subsection (a)(1), $15,000,000 for 
        fiscal year 2009; \1\ $15,187,500 for fiscal year 2010, 
        $15,375,000 for fiscal year 2011, $15,562,500 for 
        fiscal year 2012, and $15,750,000 for fiscal year 2013; 
        and
---------------------------------------------------------------------------
    \1\ So in law. The semicolon after the dollar amount for fiscal 
year 2009 should be a comma.
---------------------------------------------------------------------------
            (2) to provide grants for the purpose of carrying 
        out activities under paragraphs (2), (3), and (4) of 
        subsection (a), $15,000,000 for fiscal year 2009, 
        $15,187,500 for fiscal year 2010, $15,375,000 for 
        fiscal year 2011, $15,562,500 for fiscal year 2012, and 
        $15,750,000 for fiscal year 2013.

SEC. 1110. [300B-9] EVALUATING THE EFFECTIVENESS OF NEWBORN AND CHILD 
                    SCREENING PROGRAMS.

    (a) In General.--The Secretary shall award grants to 
eligible entities to provide for the conduct of demonstration 
programs to evaluate the effectiveness of screening, counseling 
or health care services in reducing the morbidity and mortality 
caused by heritable disorders in newborns and children.
    (b) Demonstration Programs.--A demonstration program 
conducted under a grant under this section shall be designed to 
evaluate and assess, within the jurisdiction of the entity 
receiving such grant--
            (1) the effectiveness of screening, counseling, 
        testing or specialty services for newborns and children 
        at risk for heritable disorders in reducing the 
        morbidity and mortality associated with such disorders;
            (2) the effectiveness of screening, counseling, 
        testing or specialty services in accurately and 
        reliably diagnosing heritable disorders in newborns and 
        children; or
            (3) the availability of screening, counseling, 
        testing or specialty services for newborns and children 
        at risk for heritable disorders.
    (c) Eligible Entities.--To be eligible to receive a grant 
under subsection (a) an entity shall be a State or political 
subdivision of a State, or a consortium of two or more States 
or political subdivisions of States.
    (d) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section $5,000,000 for 
fiscal year 2009, $5,062,500 for fiscal year 2010, $5,125,000 
for fiscal year 2011, $5,187,500 for fiscal year 2012, and 
$5,250,000 for fiscal year 2013.

SEC. 1111. [300B-10] ADVISORY COMMITTEE ON HERITABLE DISORDERS IN 
                    NEWBORNS AND CHILDREN.

    (a) Establishment.--The Secretary shall establish an 
advisory committee to be known as the ``Advisory Committee on 
Heritable Disorders in Newborns and Children'' (referred to in 
this section as the ``Advisory Committee'').
    (b) Duties.--The Advisory Committee shall--
            (1) provide advice and recommendations to the 
        Secretary concerning grants and projects awarded or 
        funded under section 1109;
            (2) provide technical information to the Secretary 
        for the development of policies and priorities for the 
        administration of grants under section 1109;
            (3) make systematic evidence-based and peer-
        reviewed recommendations that include the heritable 
        disorders that have the potential to significantly 
        impact public health for which all newborns should be 
        screened, including secondary conditions that may be 
        identified as a result of the laboratory methods used 
        for screening;
            (4) develop a model decision-matrix for newborn 
        screening expansion, including an evaluation of the 
        potential public health impact of such expansion, and 
        periodically update the recommended uniform screening 
        panel, as appropriate, based on such decision-matrix;
            (5) consider ways to ensure that all States attain 
        the capacity to screen for the conditions described in 
        paragraph (3), and include in such consideration the 
        results of grant funding under section 1109; and
            (6) provide such recommendations, advice or 
        information as may be necessary to enhance, expand or 
        improve the ability of the Secretary to reduce the 
        mortality or morbidity from heritable disorders, which 
        may include recommendations, advice, or information 
        dealing with--
                    (A) follow-up activities, including those 
                necessary to achieve rapid diagnosis in the 
                short-term, and those that ascertain long-term 
                case management outcomes and appropriate access 
                to related services;
                    (B) implementation, monitoring, and 
                evaluation of newborn screening activities, 
                including diagnosis, screening, follow-up, and 
                treatment activities;
                    (C) diagnostic and other technology used in 
                screening;
                    (D) the availability and reporting of 
                testing for conditions for which there is no 
                existing treatment;
                    (E) conditions not included in the 
                recommended uniform screening panel that are 
                treatable with Food and Drug Administration-
                approved products or other safe and effective 
                treatments, as determined by scientific 
                evidence and peer review;
                    (F) minimum standards and related policies 
                and procedures used by State newborn screening 
                programs, such as language and terminology used 
                by State newborn screening programs to include 
                standardization of case definitions and names 
                of disorders for which newborn screening tests 
                are performed;
                    (G) quality assurance, oversight, and 
                evaluation of State newborn screening programs, 
                including ensuring that tests and technologies 
                used by each State meet established standards 
                for detecting and reporting positive screening 
                results;
                    (H) public and provider awareness and 
                education;
                    (I) the cost and effectiveness of newborn 
                screening and medical evaluation systems and 
                intervention programs conducted by State-based 
                programs;
                    (J) identification of the causes of, public 
                health impacts of, and risk factors for 
                heritable disorders; and
                    (K) coordination of surveillance 
                activities, including standardized data 
                collection and reporting, harmonization of 
                laboratory definitions for heritable disorders 
                and testing results, and confirmatory testing 
                and verification of positive results, in order 
                to assess and enhance monitoring of newborn 
                diseases.
    (c) Membership.--
            (1) In general.--The Secretary shall appoint not to 
        exceed 15 members to the Advisory Committee. In 
        appointing such members, the Secretary shall ensure 
        that the total membership of the Advisory Committee is 
        an odd number.
            (2) Required members.--The Secretary shall appoint 
        to the Advisory Committee under paragraph (1)--
                    (A) the Administrator of the Health 
                Resources and Services Administration;
                    (B) the Director of the Centers for Disease 
                Control and Prevention;
                    (C) the Director of the National Institutes 
                of Health;
                    (D) the Director of the Agency for 
                Healthcare Research and Quality;
                    (E) the Commissioner of the Food and Drug 
                Administration;
                    (F) medical, technical, or scientific 
                professionals with special expertise in 
                heritable disorders, or in providing screening, 
                counseling, testing or specialty services for 
                newborns and children at risk for heritable 
                disorders;
                    (G) individuals with expertise in ethics 
                and infectious diseases who have worked and 
                published material in the area of newborn 
                screening;
                    (H) members of the public having special 
                expertise about or concern with heritable 
                disorders; and
                    (I) representatives from such Federal 
                agencies, public health constituencies, and 
                medical professional societies as determined to 
                be necessary by the Secretary, to fulfill the 
                duties of the Advisory Committee, as 
                established under subsection (b).
    (d) Decision on Recommendations.--
            (1) In general.--Not later than 180 days after the 
        Advisory Committee issues a recommendation pursuant to 
        this section, the Secretary shall adopt or reject such 
        recommendation.
            (2) Pending recommendations.--The Secretary shall 
        adopt or reject any recommendation issued by the 
        Advisory Committee that is pending on the date of 
        enactment of the Newborn Screening Saves Lives Act of 
        2008 by not later than 180 days after the date of 
        enactment of such Act.
            (3) Determinations to be made public.--The 
        Secretary shall publicize any determination on adopting 
        or rejecting a recommendation of the Advisory Committee 
        pursuant to this subsection, including the 
        justification for the determination.
    (e) Annual Report.--Not later than 3 years after the date 
of enactment of the Newborn Screening Saves Lives Act of 2008, 
and each fiscal year thereafter, the Advisory Committee shall--
            (1) publish a report on peer-reviewed newborn 
        screening guidelines, including follow-up and 
        treatment, in the United States;
            (2) submit such report to the appropriate 
        committees of Congress, the Secretary, the Interagency 
        Coordinating Committee established under Section 1114, 
        and the State departments of health; and
            (3) disseminate such report on as wide a basis as 
        practicable, including through posting on the internet 
        clearinghouse established under section 1112.
    (f) Continuation of Operation of Committee.--
Notwithstanding section 14 of the Federal Advisory Committee 
Act (5 U.S.C. App.), the Advisory Committee shall continue to 
operate during the 5-year period beginning on the date of 
enactment of the Newborn Screening Saves Lives Act of 2008.
    (g) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section, $1,000,000 for 
fiscal year 2009, $1,012,500 for fiscal year 2010, $1,025,000 
for fiscal year 2011, $1,037,500 for fiscal year 2012, and 
$1,050,000 for fiscal year 2013.

SEC. 1112. [300B-11] CLEARINGHOUSE OF NEWBORN SCREENING INFORMATION.

    (a) In General.--The Secretary, acting through the 
Administrator of the Health Resources and Services 
Administration (referred to in this part as the 
``Administrator''), in consultation with the Director of the 
Centers for Disease Control and Prevention and the Director of 
the National Institutes of Health, shall establish and maintain 
a central clearinghouse of current educational and family 
support and services information, materials, resources, 
research, and data on newborn screening to--
            (1) enable parents and family members of newborns, 
        health professionals, industry representatives, and 
        other members of the public to increase their 
        awareness, knowledge, and understanding of newborn 
        screening;
            (2) increase awareness, knowledge, and 
        understanding of newborn diseases and screening 
        services for expectant individuals and families; and
            (3) maintain current data on quality indicators to 
        measure performance of newborn screening, such as 
        false-positive rates and other quality indicators as 
        determined by the Advisory Committee under section 
        1111.
    (b) Internet Availability.--The Secretary, acting through 
the Administrator, shall ensure that the clearinghouse 
described under subsection (a)--
            (1) is available on the Internet;
            (2) includes an interactive forum;
            (3) is updated on a regular basis, but not less 
        than quarterly; and
            (4) provides--
                    (A) links to Government-sponsored, non-
                profit, and other Internet websites of 
                laboratories that have demonstrated expertise 
                in newborn screening that supply research-based 
                information on newborn screening tests 
                currently available throughout the United 
                States;
                    (B) information about newborn conditions 
                and screening services available in each State 
                from laboratories certified under subpart 2 of 
                part F of title III, including information 
                about supplemental screening that is available 
                but not required, in the State where the infant 
                is born;
                    (C) current research on both treatable and 
                not-yet treatable conditions for which newborn 
                screening tests are available;
                    (D) the availability of Federal funding for 
                newborn and child screening for heritable 
                disorders including grants authorized under the 
                Newborn Screening Saves Lives Act of 2008; and
                    (E) other relevant information as 
                determined appropriate by the Secretary.
    (c) Nonduplication.--In developing the clearinghouse under 
this section, the Secretary shall ensure that such 
clearinghouse minimizes duplication and supplements, not 
supplants, existing information sharing efforts.
    (d) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section, $2,500,000 for 
fiscal year 2009, $2,531,250 for fiscal year 2010, $2,562,500 
for fiscal year 2011, $2,593,750 for fiscal year 2012, and 
$2,625,000 for fiscal year 2013.

SEC. 1113. [300B-12] LABORATORY QUALITY.

    (a) In General.--The Secretary, acting through the Director 
of the Centers for Disease Control and Prevention and in 
consultation with the Advisory Committee on Heritable Disorders 
in Newborns and Children established under section 1111, shall 
provide for--
            (1) quality assurance for laboratories involved in 
        screening newborns and children for heritable 
        disorders, including quality assurance for newborn-
        screening tests, performance evaluation services, and 
        technical assistance and technology transfer to newborn 
        screening laboratories to ensure analytic validity and 
        utility of screening tests; and
            (2) appropriate quality control and other 
        performance test materials to evaluate the performance 
        of new screening tools.
    (b) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated $5,000,000 for fiscal year 2009, $5,062,500 for 
fiscal year 2010, $5,125,000 for fiscal year 2011, $5,187,500 
for fiscal year 2012, and $5,250,000 for fiscal year 2013.

SEC. 1114. [300B-13] INTERAGENCY COORDINATING COMMITTEE ON NEWBORN AND 
                    CHILD SCREENING.

    (a) Purpose.--It is the purpose of this section to--
            (1) assess existing activities and infrastructure, 
        including activities on birth defects and developmental 
        disabilities authorized under section 317C, in order to 
        make recommendations for programs to collect, analyze, 
        and make available data on the heritable disorders 
        recommended by the Advisory Committee on Heritable 
        Disorders in Newborns and Children under section 1111, 
        including data on the incidence and prevalence of, as 
        well as poor health outcomes resulting from, such 
        disorders; and
            (2) make recommendations for the establishment of 
        regional centers for the conduct of applied 
        epidemiological research on effective interventions to 
        promote the prevention of poor health outcomes 
        resulting from such disorders as well as providing 
        information and education to the public on such 
        effective interventions.
    (b) Establishment.--The Secretary shall establish an 
Interagency Coordinating Committee on Newborn and Child 
Screening (referred to in this section as the ``Interagency 
Coordinating Committee'') to carry out the purpose of this 
section.
    (c) Composition.--The Interagency Coordinating Committee 
shall be composed of the Director of the Centers for Disease 
Control and Prevention, the Administrator, the Director of the 
Agency for Healthcare Research and Quality, and the Director of 
the National Institutes of Health, or their designees.
    (d) Activities.--The Interagency Coordinating Committee 
shall--
            (1) report to the Secretary and the appropriate 
        committees of Congress on its recommendations related 
        to the purpose described in subsection (a); and
            (2) carry out other activities determined 
        appropriate by the Secretary.
    (e) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated $1,000,000 for fiscal year 2009, $1,012,500 for 
fiscal year 2010, $1,025,000 for fiscal year 2011, $1,037,500 
for fiscal year 2012, and $1,050,000 for fiscal year 2013.

SEC. 1115. [300B-14] NATIONAL CONTINGENCY PLAN FOR NEWBORN SCREENING.

    (a) In General.--Not later than 180 days after the date of 
enactment of this section, the Secretary, acting through the 
Director of the Centers for Disease Control and Prevention and 
in consultation with the Administrator and State departments of 
health (or related agencies), shall develop a national 
contingency plan for newborn screening for use by a State, 
region, or consortia \1\ of States in the event of a public 
health emergency.
---------------------------------------------------------------------------
    \1\ The reference to ``consortia of States'' in subsection (a) 
probably should refer to the ``consortium of States''.
---------------------------------------------------------------------------
    (b) Contents.--The contingency plan developed under 
subsection (a) shall include a plan for--
            (1) the collection and transport of specimens;
            (2) the shipment of specimens to State newborn 
        screening laboratories;
            (3) the processing of specimens;
            (4) the reporting of screening results to 
        physicians and families;
            (5) the diagnostic confirmation of positive 
        screening results;
            (6) ensuring the availability of treatment and 
        management resources;
            (7) educating families about newborn screening; and
            (8) carrying out other activities determined 
        appropriate by the Secretary.

SEC. 1116. [300B-15] HUNTER KELLY RESEARCH PROGRAM.

    (a) Newborn Screening Activities.--
            (1) In general.--The Secretary, in conjunction with 
        the Director of the National Institutes of Health and 
        taking into consideration the recommendations of the 
        Advisory Committee, may continue carrying out, 
        coordinating, and expanding research in newborn 
        screening (to be known as ``Hunter Kelly Newborn 
        Screening Research Program'') including--
                    (A) identifying, developing, and testing 
                the most promising new screening technologies, 
                in order to improve already existing screening 
                tests, increase the specificity of newborn 
                screening, and expand the number of conditions 
                for which screening tests are available;
                    (B) experimental treatments and disease 
                management strategies for additional newborn 
                conditions, and other genetic, metabolic, 
                hormonal, or functional conditions that can be 
                detected through newborn screening for which 
                treatment is not yet available; and
                    (C) other activities that would improve 
                newborn screening, as identified by the 
                Director.
            (2) Additional newborn condition.--For purposes of 
        this subsection, the term ``additional newborn 
        condition'' means any condition that is not one of the 
        core conditions recommended by the Advisory Committee 
        and adopted by the Secretary.
    (b) Funding.--In carrying out the research program under 
this section, the Secretary and the Director shall ensure that 
entities receiving funding through the program will provide 
assurances, as practicable, that such entities will work in 
consultation with the appropriate State departments of health, 
and, as practicable, focus their research on screening 
technology not currently performed in the States in which the 
entities are located, and the conditions on the uniform 
screening panel (or the standard test existing on the uniform 
screening panel).
    (c) Reports.--The Director is encouraged to include 
information about the activities carried out under this section 
in the biennial report required under section 403 of the 
National Institutes of Health Reform Act of 2006. If such 
information is included, the Director shall make such 
information available to be included on the Internet 
Clearinghouse established under section 1112.
    (d) Nonduplication.--In carrying out programs under this 
section, the Secretary shall minimize duplication and 
supplement, not supplant, existing efforts of the type carried 
out under this section.
    (e) Peer Review.--Nothing in this section shall be 
construed to interfere with the scientific peer-review process 
at the National Institutes of Health.

                  Part B--Sudden Infant Death Syndrome

       sudden infant death syndrome research and research reports

    Sec. 1122. [300c-12] From the sums appropriated to the 
Eunice Kennedy Shriver National Institute of Child Health and 
Human Development, the Secretary shall assure that there are 
applied to research of the type described in subparagraphs (A) 
and (B) of subsection (b)(1) of this section such amounts each 
year as will be adequate, given the leads and findings then 
available from such research, in order to make maximum feasible 
progress toward identification of infants at risk of sudden 
infant death syndrome and prevention of sudden infant death 
syndrome.

                      Part C--Hemophilia Programs

                        blood separation centers

    Sec. 1132. [300c-22] (a) The Secretary may make grants to 
and enter into contracts with public and nonprofit private 
entities for projects to develop and expand, within existing 
facilities, blood-separation centers to separate and make 
available for distribution blood components to providers of 
blood services and manufacturers of blood fractions. For 
purposes of this section--
            (1) the term ``blood components'' means those 
        constituents of whole blood which are used for therapy 
        and which are obtained by physical separation processes 
        which result in licensed products such as red blood 
        cells, platelets, white blood cells, AHF-rich plasma, 
        fresh-frozen plasma, cryoprecipitate, and single unit 
        plasma for infusion; and
            (2) the term ``blood fractions'' means those 
        constituents of plasma which are used for therapy and 
        which are obtained by licensed fractionation processes 
        presently used in manufacturing which result in 
        licensed products such as normal serum albumin, plasma, 
        protein fraction, prothrombin complex, fibrinogen, AHF 
        concentrate, immune serum globulin, and hyperimmune 
        globulins.
    (b) In the event the Secretary finds that there is an 
insufficient supply of blood fractions available to meet the 
needs for treatment of persons suffering from hemophilia, and 
that public and other nonprofit private centers already engaged 
in the production of blood fractions could alleviate such 
insufficiency with assistance under this subsection, he may 
make grants not to exceed $500,000 to such centers for the 
purposes of alleviating the insufficiency.
    (c) No grant or contract may be made under subsection (a) 
or (b) unless an application therefor has been submitted to and 
approved by the Secretary. Such an application shall be in such 
form, submitted in such manner, and contain such information as 
the Secretary shall by regulation prescribe.
    (d) Contracts may be entered into under subsection (a) 
without regard to section 3648 and 3709 of the Revised Statutes 
(31 U.S.C. 529; 41 U.S.C. 5).
    (e) For the purpose of making payments under grants and 
contracts under subsections (a) and (b), there are authorized 
to be appropriated $4,000,000 for fiscal year 1976, $5,000,000 
for the fiscal year ending September 30, 1977, $3,450,000 for 
the fiscal year ending September 30, 1978, $2,500,000 for the 
fiscal year ending September 30, 1979, $3,000,000 for the 
fiscal year ending September 30, 1980, $3,500,000 for the 
fiscal year ending September 30, 1981.ATTORNEY: PMG/FD 
(June 28, 1999) deg.
                         TITLE XII--TRAUMA CARE

           Part A--General Authority and Duties of Secretary

SEC. 1201. [300D] ESTABLISHMENT.

    (a) In General.--The Secretary shall, with respect to 
trauma care--
            (1) conduct and support research, training, 
        evaluations, and demonstration projects;
            (2) foster the development of appropriate, modern 
        systems of such care through the sharing of information 
        among agencies and individuals involved in the study 
        and provision of such care;
            (3) collect, compile, and disseminate information 
        on the achievements of, and problems experienced by, 
        State and local agencies and private entities in 
        providing trauma care and emergency medical services 
        and, in so doing, give special consideration to the 
        unique needs of rural areas;
            (4) provide to State and local agencies technical 
        assistance to enhance each State's capability to 
        develop, implement, and sustain the trauma care 
        component of each State's plan for the provision of 
        emergency medical services;
            (5) sponsor workshops and conferences; and
            (6) promote the collection and categorization of 
        trauma data in a consistent and standardized manner.
    (b) Grants, Cooperative Agreements, and Contracts.--The 
Secretary may make grants, and enter into cooperative 
agreements and contracts, for the purpose of carrying out 
subsection (a).

SEC. 1202. [300D-3] ESTABLISHMENT OF PROGRAMS FOR IMPROVING TRAUMA CARE 
                    IN RURAL AREAS.

    (a) In General.--The Secretary may make grants to public 
and nonprofit private entities for the purpose of carrying out 
research and demonstration projects with respect to improving 
the availability and quality of emergency medical services in 
rural areas--
            (1) by developing innovative uses of communications 
        technologies and the use of new communications 
        technology;
            (2) by developing model curricula, such as advanced 
        trauma life support, for training emergency medical 
        services personnel, including first responders, 
        emergency medical technicians, emergency nurses and 
        physicians, and paramedics--
                    (A) in the assessment, stabilization, 
                treatment, preparation for transport, and 
                resuscitation of seriously injured patients, 
                with special attention to problems that arise 
                during long transports and to methods of 
                minimizing delays in transport to the 
                appropriate facility; and
                    (B) in the management of the operation of 
                the emergency medical services system;
            (3) by making training for original certification, 
        and continuing education, in the provision and 
        management of emergency medical services more 
        accessible to emergency medical personnel in rural 
        areas through telecommunications, home studies, 
        providing teachers and training at locations accessible 
        to such personnel, and other methods;
            (4) by developing innovative protocols and 
        agreements to increase access to prehospital care and 
        equipment necessary for the transportation of seriously 
        injured patients to the appropriate facilities;
            (5) by evaluating the effectiveness of protocols 
        with respect to emergency medical services and systems; 
        and
            (6) by increasing communication and coordination 
        with State trauma systems.
    (b) Special Consideration for Certain Rural Areas.--In 
making grants under subsection (a), the Secretary shall give 
special consideration to any applicant for the grant that will 
provide services under the grant in any rural area identified 
by a State under section 1214(d)(1).
    (c) Requirement of Application.--The Secretary may not make 
a grant under subsection (a) unless an application for the 
grant is submitted to the Secretary and the application is in 
such form, is made in such manner, and contains such 
agreements, assurances, and information as the Secretary 
determines to be necessary to carry out this section.

SEC. 1203. [300D-5] COMPETITIVE GRANTS FOR TRAUMA SYSTEMS FOR THE 
                    IMPROVEMENT OF TRAUMA CARE.

    (a) In General.--The Secretary, acting through the 
Assistant Secretary for Preparedness and Response, may make 
grants to States, political subdivisions, or consortia of 
States or political subdivisions for the purpose of improving 
access to and enhancing the development of trauma care systems.
    (b) Use of Funds.--The Secretary may make a grant under 
this section only if the applicant agrees to use the grant--
            (1) to integrate and broaden the reach of a trauma 
        care system, such as by developing innovative protocols 
        to increase access to prehospital care;
            (2) to strengthen, develop, and improve an existing 
        trauma care system;
            (3) to expand communications between the trauma 
        care system and emergency medical services through 
        improved equipment or a telemedicine system;
            (4) to improve data collection and retention; or
            (5) to increase education, training, and technical 
        assistance opportunities, such as training and 
        continuing education in the management of emergency 
        medical services accessible to emergency medical 
        personnel in rural areas through telehealth, home 
        studies, and other methods.
    (c) Preference.--In selecting among States, political 
subdivisions, and consortia of States or political subdivisions 
for purposes of making grants under this section, the Secretary 
shall give preference to applicants that--
            (1) have developed a process, using national 
        standards, for designating trauma centers;
            (2) recognize protocols for the delivery of 
        seriously injured patients to trauma centers;
            (3) implement a process for evaluating the 
        performance of the trauma system; and
            (4) agree to participate in information systems 
        described in section 1202 by collecting, providing, and 
        sharing information.
    (d) Priority.--In making grants under this section, the 
Secretary shall give priority to applicants that will use the 
grants to focus on improving access to trauma care systems.
    (e) Special Consideration.--In awarding grants under this 
section, the Secretary shall give special consideration to 
projects that demonstrate strong State or local support, 
including availability of non-Federal contributions.

SEC. 1204. [300D-6] COMPETITIVE GRANTS FOR REGIONALIZED SYSTEMS FOR 
                    EMERGENCY CARE RESPONSE.

    (a) In General.--The Secretary, acting through the 
Assistant Secretary for Preparedness and Response, shall award 
not fewer than 4 multiyear contracts or competitive grants to 
eligible entities to support pilot projects that design, 
implement, and evaluate innovative models of regionalized, 
comprehensive, and accountable emergency care and trauma 
systems.
    (b) Eligible Entity; Region.--In this section:
            (1) Eligible entity.--The term ``eligible entity'' 
        means--
                    (A) a State or a partnership of 1 or more 
                States and 1 or more local governments; or
                    (B) an Indian tribe (as defined in section 
                4 of the Indian Health Care Improvement Act) or 
                a partnership of 1 or more Indian tribes.
            (2) Region.--The term ``region'' means an area 
        within a State, an area that lies within multiple 
        States, or a similar area (such as a multicounty area), 
        as determined by the Secretary.
            (3) Emergency services.--The term ``emergency 
        services'' includes acute, prehospital, and trauma 
        care.
    (c) Pilot Projects.--The Secretary shall award a contract 
or grant under subsection (a) to an eligible entity that 
proposes a pilot project to design, implement, and evaluate an 
emergency medical and trauma system that--
            (1) coordinates with public health and safety 
        services, emergency medical services, medical 
        facilities, trauma centers, and other entities in a 
        region to develop an approach to emergency medical and 
        trauma system access throughout the region, including 
        9-1-1 Public Safety Answering Points and emergency 
        medical dispatch;
            (2) includes a mechanism, such as a regional 
        medical direction or transport communications system, 
        that operates throughout the region to ensure that the 
        patient is taken to the medically appropriate facility 
        (whether an initial facility or a higher-level 
        facility) in a timely fashion;
            (3) allows for the tracking of prehospital and 
        hospital resources, including inpatient bed capacity, 
        emergency department capacity, trauma center capacity, 
        on-call specialist coverage, ambulance diversion 
        status, and the coordination of such tracking with 
        regional communications and hospital destination 
        decisions; and
            (4) includes a consistent region-wide prehospital, 
        hospital, and interfacility data management system 
        that--
                    (A) submits data to the National EMS 
                Information System, the National Trauma Data 
                Bank, and others;
                    (B) reports data to appropriate Federal and 
                State databanks and registries; and
                    (C) contains information sufficient to 
                evaluate key elements of prehospital care, 
                hospital destination decisions, including 
                initial hospital and interfacility decisions, 
                and relevant health outcomes of hospital care.
    (d) Application.--
            (1) In general.--An eligible entity that seeks a 
        contract or grant described in subsection (a) shall 
        submit to the Secretary an application at such time and 
        in such manner as the Secretary may require.
            (2) Application information.--Each application 
        shall include--
                    (A) an assurance from the eligible entity 
                that the proposed system--
                            (i) has been coordinated with the 
                        applicable State Office of Emergency 
                        Medical Services (or equivalent State 
                        office);
                            (ii) includes consistent indirect 
                        and direct medical oversight of 
                        prehospital, hospital, and 
                        interfacility transport throughout the 
                        region;
                            (iii) coordinates prehospital 
                        treatment and triage, hospital 
                        destination, and interfacility 
                        transport throughout the region;
                            (iv) includes a categorization or 
                        designation system for special medical 
                        facilities throughout the region that 
                        is integrated with transport and 
                        destination protocols;
                            (v) includes a regional medical 
                        direction, patient tracking, and 
                        resource allocation system that 
                        supports day-to-day emergency care and 
                        surge capacity and is integrated with 
                        other components of the national and 
                        State emergency preparedness system; 
                        and
                            (vi) addresses pediatric concerns 
                        related to integration, planning, 
                        preparedness, and coordination of 
                        emergency medical services for infants, 
                        children and adolescents; and
                    (B) such other information as the Secretary 
                may require.
    (e) Requirement of Matching Funds.--
            (1) In general.--The Secretary may not make a grant 
        under this section unless the State (or consortia of 
        States) involved agrees, with respect to the costs to 
        be incurred by the State (or consortia) in carrying out 
        the purpose for which such grant was made, to make 
        available non-Federal contributions (in cash or in kind 
        under paragraph (2)) toward such costs in an amount 
        equal to not less than $1 for each $3 of Federal funds 
        provided in the grant. Such contributions may be made 
        directly or through donations from public or private 
        entities.
            (2) Non-federal contributions.--Non-Federal 
        contributions required in paragraph (1) may be in cash 
        or in kind, fairly evaluated, including equipment or 
        services (and excluding indirect or overhead costs). 
        Amounts provided by the Federal Government, or services 
        assisted or subsidized to any significant extent by the 
        Federal Government, may not be included in determining 
        the amount of such non-Federal contributions.
    (f) Priority.--The Secretary shall give priority for the 
award of the contracts or grants described in subsection (a) to 
any eligible entity that serves a population in a medically 
underserved area (as defined in section 330(b)(3)).
    (g) Report.--Not later than 90 days after the completion of 
a pilot project under subsection (a), the recipient of such 
contract or grant described in shall submit to the Secretary a 
report containing the results of an evaluation of the program, 
including an identification of--
            (1) the impact of the regional, accountable 
        emergency care and trauma system on patient health 
        outcomes for various critical care categories, such as 
        trauma, stroke, cardiac emergencies, neurological 
        emergencies, and pediatric emergencies;
            (2) the system characteristics that contribute to 
        the effectiveness and efficiency of the program (or 
        lack thereof);
            (3) methods of assuring the long-term financial 
        sustainability of the emergency care and trauma system;
            (4) the State and local legislation necessary to 
        implement and to maintain the system;
            (5) the barriers to developing regionalized, 
        accountable emergency care and trauma systems, as well 
        as the methods to overcome such barriers; and
            (6) recommendations on the utilization of available 
        funding for future regionalization efforts.
    (h) Dissemination of Findings.--The Secretary shall, as 
appropriate, disseminate to the public and to the appropriate 
Committees of the Congress, the information contained in a 
report made under subsection (g).

  Part B--Formula Grants With Respect to Modifications of State Plans

 H4  deg.SEC. 1211. [300D-11] ESTABLISHMENT OF PROGRAM.

    (a) Requirement of Allotments for States.--The Secretary 
shall for each fiscal year make an allotment for each State in 
an amount determined in accordance with section 1218. The 
Secretary shall make payments, as grants, each fiscal year to 
each State from the allotment for the State if the Secretary 
approves for the fiscal year involved an application submitted 
by the State pursuant to section 1217.
    (b) Purpose.--Except as provided in section 1233, the 
Secretary may not make payments under this part for a fiscal 
year unless the State involved agrees that, with respect to the 
trauma care component of the State plan for the provision of 
emergency medical services, the payments will be expended only 
for the purpose of developing, implementing, and monitoring the 
modifications to such component described in section 1213.

SEC. 1212. [300D-12] REQUIREMENT OF MATCHING FUNDS FOR FISCAL YEARS 
                    SUBSEQUENT TO FIRST FISCAL YEAR OF PAYMENTS.

    (a) Non-Federal Contributions.--
            (1) In general.--The Secretary may not make 
        payments under section 1211(a) unless the State 
        involved agrees, with respect to the costs described in 
        paragraph (2), to make available non-Federal 
        contributions (in cash or in kind under subsection 
        (b)(1)) toward such costs in an amount that--
                    (A) for the second and third fiscal years 
                of such payments to the State, is not less than 
                $1 for each $1 of Federal funds provided in 
                such payments for such fiscal years; and
                    (B) for the fourth and subsequent fiscal 
                years of such payments to the State, is not 
                less than $2 for each $1 of Federal funds 
                provided in such payments for such fiscal 
                years.
            (2) Program costs.--The costs referred to in 
        paragraph (1) are--
                    (A) the costs to be incurred by the State 
                in carrying out the purpose described in 
                section 1211(b); or
                    (B) the costs of improving the quality and 
                availability of emergency medical services in 
                rural areas of the State.
            (3) Initial year of payments.--The Secretary may 
        not require a State to make non-Federal contributions 
        as a condition of receiving payments under section 
        1211(a) for the first fiscal year of such payments to 
        the State.
    (b) Determination of Amount of Non-Federal Contribution.--
With respect to compliance with subsection (a) as a condition 
of receiving payments under section 1211(a)--
            (1) a State may make the non-Federal contributions 
        required in such subsection in cash or in kind, fairly 
        evaluated, including plant, equipment, or services; and
            (2) the Secretary may not, in making a 
        determination of the amount of non-Federal 
        contributions, include amounts provided by the Federal 
        Government or services assisted or subsidized to any 
        significant extent by the Federal Government.

SEC. 1213. [300D-13] REQUIREMENTS WITH RESPECT TO CARRYING OUT PURPOSE 
                    OF ALLOTMENTS.

    (a) Trauma Care Modifications to State Plan for Emergency 
Medical Services.--With respect to the trauma care component of 
a State plan for the provision of emergency medical services, 
the modifications referred to in section 1211(b) are such 
modifications to the State plan as may be necessary for the 
State involved to ensure that the plan provides for access to 
the highest possible quality of trauma care, and that the 
plan--
            (1) specifies that the modifications required 
        pursuant to paragraphs (2) through (11) will be 
        implemented by the principal State agency with respect 
        to emergency medical services or by the designee of 
        such agency;
            (2) specifies a public or private entity that will 
        designate trauma care regions and trauma centers in the 
        State;
            (3) subject to subsection (b), contains national 
        standards and requirements of the American College of 
        Surgeons or another appropriate entity for the 
        designation of level I and level II trauma centers, and 
        in the case of rural areas level III trauma centers 
        (including trauma centers with specified capabilities 
        and expertise in the care of pediatric trauma 
        patients), by such entity, including standards and 
        requirements for--
                    (A) the number and types of trauma patients 
                for whom such centers must provide care in 
                order to ensure that such centers will have 
                sufficient experience and expertise to be able 
                to provide quality care for victims of injury;
                    (B) the resources and equipment needed by 
                such centers; and
                    (C) the availability of rehabilitation 
                services for trauma patients;
            (4) contains standards and requirements for the 
        implementation of regional trauma care systems, 
        including standards and guidelines (consistent with the 
        provisions of section 1867 of the Social Security Act) 
        for medically directed triage and transportation of 
        trauma patients (including patients injured in rural 
        areas) prior to care in designated trauma centers;
            (5) subject to subsection (b), contains national 
        standards and requirements, including those of the 
        American Academy of Pediatrics and the American College 
        of Emergency Physicians, for medically directed triage 
        and transport of severely injured children to 
        designated trauma centers with specified capabilities 
        and expertise in the care of pediatric trauma patients;
            (6) utilizes a program with procedures for the 
        evaluation of designated trauma centers (including 
        trauma centers described in paragraph (5)) and trauma 
        care systems;
            (7) provides for the establishment and collection 
        of data in accordance with data collection requirements 
        developed in consultation with surgical, medical, and 
        nursing specialty groups, State and local emergency 
        medical services directors, and other trained 
        professionals in trauma care, from each designated 
        trauma center in the State of a central data reporting 
        and analysis system--
                    (A) to identify the number of severely 
                injured trauma patients and the number of 
                deaths from trauma within trauma care systems 
                in the State;
                    (B) to identify the cause of the injury and 
                any factors contributing to the injury;
                    (C) to identify the nature and severity of 
                the injury;
                    (D) to monitor trauma patient care 
                (including prehospital care) in each designated 
                trauma center within regional trauma care 
                systems in the State (including relevant 
                emergency-department discharges and 
                rehabilitation information) for the purpose of 
                evaluating the diagnosis, treatment, and 
                treatment outcome of such trauma patients;
                    (E) to identify the total amount of 
                uncompensated trauma care expenditures for each 
                fiscal year by each designated trauma center in 
                the State; and
                    (F) to identify patients transferred within 
                a regional trauma system, including reasons for 
                such transfer and the outcomes of such 
                patients;
            (8) provides for the use of procedures by 
        paramedics and emergency medical technicians to assess 
        the severity of the injuries incurred by trauma 
        patients;
            (9) provides for appropriate transportation and 
        transfer policies to ensure the delivery of patients to 
        designated trauma centers and other facilities within 
        and outside of the jurisdiction of such system, 
        including policies to ensure that only individuals 
        appropriately identified as trauma patients are 
        transferred to designated trauma centers, and to 
        provide periodic reviews of the transfers and the 
        auditing of such transfers that are determined to be 
        appropriate;
            (10) conducts public education activities 
        concerning injury prevention and obtaining access to 
        trauma care;
            (11) coordinates planning for trauma systems with 
        State disaster emergency planning and bioterrorism 
        hospital preparedness planning; and
            (12) with respect to the requirements established 
        in this subsection, provides for coordination and 
        cooperation between the State and any other State with 
        which the State shares any standard metropolitan 
        statistical area.
    (b) Certain Standards With Respect to Trauma Care Centers 
and Systems.--
            (1) In general.--The Secretary may not make 
        payments under section 1211(a) for a fiscal year unless 
        the State involved agrees that, in carrying out 
        paragraphs (3) through (5) of subsection (a), the State 
        will adopt standards for the designation of trauma 
        centers, and for triage, transfer, and transportation 
        policies, and that the State will, in adopting such 
        standards--
                    (A) take into account national standards 
                that outline resources for optimal care of 
                injured patients;
                    (B) consult with medical, surgical, and 
                nursing speciality groups, hospital 
                associations, emergency medical services State 
                and local directors, concerned advocates, and 
                other interested parties;
                    (C) conduct hearings on the proposed 
                standards after providing adequate notice to 
                the public concerning such hearing; and
                    (D) beginning in fiscal year 2008, take 
                into account the model plan described in 
                subsection (c).
            (2) Quality of trauma care.--The highest quality of 
        trauma care shall be the primary goal of State 
        standards adopted under this subsection.
            (3) Approval by the secretary.--The Secretary may 
        not make payments under section 1211(a) to a State if 
        the Secretary determines that--
                    (A) in the case of payments for fiscal year 
                2008 and subsequent fiscal years, the State has 
                not taken into account national standards, 
                including those of the American College of 
                Surgeons, the American College of Emergency 
                Physicians, and the American Academy of 
                Pediatrics, in adopting standards under this 
                subsection; or
                    (B) in the case of payments for fiscal year 
                2008 and subsequent fiscal years, the State has 
                not, in adopting such standards, taken into 
                account the model plan developed under 
                subsection (c).
    (c) Model Trauma Care Plan.--
            (1) In general.--Not later than 1 year after the 
        date of the enactment of the Trauma Care Systems 
        Planning and Development Act of 2007, the Secretary 
        shall update the model plan for the designation of 
        trauma centers and for triage, transfer, and 
        transportation policies that may be adopted for 
        guidance by the State. Such plan shall--
                    (A) take into account national standards, 
                including those of the American College of 
                Surgeons, American College of Emergency 
                Physicians, and the American Academy of 
                Pediatrics;
                    (B) take into account existing State plans;
                    (C) be developed in consultation with 
                medical, surgical, and nursing speciality 
                groups, hospital associations, emergency 
                medical services State directors and 
                associations, and other interested parties; and
                    (D) include standards for the designation 
                of rural health facilities and hospitals best 
                able to receive, stabilize, and transfer trauma 
                patients to the nearest appropriate designated 
                trauma center, and for triage, transfer, and 
                transportation policies as they relate to rural 
                areas.
            (2) Applicability.--Standards described in 
        paragraph (1)(D) shall be applicable to all rural areas 
        in the State, including both non-metropolitan areas and 
        frontier areas that have populations of less than 6,000 
        per square mile.
    (d) Rule of Construction With Respect to Number of 
Designated Trauma Centers.--With respect to compliance with 
subsection (a) as a condition of the receipt of a grant under 
section 1211(a), such subsection may not be construed to 
specify the number of trauma care centers designated pursuant 
to such subsection.

SEC. 1214. [300D-14] REQUIREMENT OF SUBMISSION TO SECRETARY OF TRAUMA 
                    PLAN AND CERTAIN INFORMATION.

    (a) In General.--For each fiscal year, the Secretary may 
not make payments to a State under section 1211(a) unless, 
subject to subsection (b), the State submits to the Secretary 
the trauma care component of the State plan for the provision 
of emergency medical services, including any changes to the 
trauma care component and any plans to address deficiencies in 
the trauma care component.
    (b) Interim Plan or Description of Efforts.--For each 
fiscal year, if a State has not completed the trauma care 
component of the State plan described in subsection (a), the 
State may provide, in lieu of such completed component, an 
interim component or a description of efforts made toward the 
completion of the component.
    (c) Information Received by State Reporting and Analysis 
System.--The Secretary may not make payments to a State under 
section 1211(a) unless the State agrees that the State will, 
not less than once each year, provide to the Secretary the 
information received by the State pursuant to section 
1213(a)(7).
    (d) Availability of Emergency Medical Services in Rural 
Areas.--The Secretary may not make payments to a State under 
section 1211(a) unless--
            (1) the State identifies any rural area in the 
        State for which--
                    (A) there is no system of access to 
                emergency medical services through the 
                telephone number 911;
                    (B) there is no basic life-support system; 
                or
                    (C) there is no advanced life-support 
                system; and
            (2) the State submits to the Secretary a list of 
        rural areas identified pursuant to paragraph (1) or, if 
        there are no such areas, a statement that there are no 
        such areas.

SEC. 1215. [300D-15] RESTRICTIONS ON USE OF PAYMENTS.

    (a) In General.--The Secretary may not, except as provided 
in subsection (b), make payments under section 1211(a) for a 
fiscal year unless the State involved agrees that the payments 
will not be expended--
            (1) for any purpose other than developing, 
        implementing, and monitoring the modifications required 
        by section 1211(b) to be made to the State plan for the 
        provision of emergency medical services;
            (2) to make cash payments to intended recipients of 
        services provided pursuant to this section;
            (3) to purchase or improve real property (other 
        than minor remodeling of existing improvements to real 
        property);
            (4) to satisfy any requirement for the expenditure 
        of non-Federal funds as a condition for the receipt of 
        Federal funds; or
            (5) to provide financial assistance to any entity 
        other than a public or nonprofit private entity.
    (b) Waiver.--The Secretary may waive a restriction under 
subsection (a) only if the Secretary determines that the 
activities outlined by the State plan submitted under section 
1214(a) by the State involved cannot otherwise be carried out.

SEC. 1217. [300D-17] REQUIREMENT OF SUBMISSION OF APPLICATION 
                    CONTAINING CERTAIN AGREEMENTS AND ASSURANCES.

    The Secretary may not make payments under section 1211(a) 
to a State for a fiscal year unless--
            (1) the State submits to the Secretary an 
        application for the payments containing agreements in 
        accordance with this part;
            (2) the agreements are made through certification 
        from the chief executive officer of the State;
            (3) with respect to such agreements, the 
        application provides assurances of compliance 
        satisfactory to the Secretary;
            (4) the application contains the plan provisions 
        and the information required to be submitted to the 
        Secretary pursuant to section 1214; and
            (5) the application otherwise is in such form, is 
        made in such manner, and contains such agreements, 
        assurances, and information as the Secretary determines 
        to be necessary to carry out this part.

SEC. 1218. [300D-18] DETERMINATION OF AMOUNT OF ALLOTMENT.

    (a) Minimum Allotment.--Subject to the extent of amounts 
made available in appropriations Acts, the amount of an 
allotment under section 1211(a) for a State for a fiscal year 
shall be the greater of--
            (1) the amount determined under subsection (b)(1); 
        and
            (2) $250,000 in the case of each of the several 
        States, the District of Columbia, and the Commonwealth 
        of Puerto Rico, and $50,000 in the case of each of the 
        Virgin Islands, Guam, American Samoa, and the 
        Commonwealth of the Northern Mariana Islands.
    (b) Determination Under Formula.--
            (1) In general.--The amount referred to in 
        subsection (a)(1) for a State for a fiscal year is the 
        sum of--
                    (A) an amount determined under paragraph 
                (2); and
                    (B) an amount determined under paragraph 
                (3).
            (2) Amount relating to population.--The amount 
        referred to in subparagraph (A) of paragraph (1) for a 
        State for a fiscal year is the product of--
                    (A) an amount equal to 80 percent of the 
                amounts appropriated under section 1232(a) for 
                the fiscal year and available for allotment 
                under section 1211(a); and
                    (B) a percentage equal to the quotient of--
                            (i) an amount equal to the 
                        population of the State; divided by
                            (ii) an amount equal to the 
                        population of all States.
            (3) Amount relating to square mileage.--The amount 
        referred to in subparagraph (B) of paragraph (1) for a 
        State for a fiscal year is the product of--
                    (A) an amount equal to 20 percent of the 
                amounts appropriated under section 1232(a) for 
                the fiscal year and available for allotment 
                under section 1211(a); and
                    (B) a percentage equal to the quotient of--
                            (i) an amount equal to the lesser 
                        of 266,807 and the amount of the square 
                        mileage of the State; divided by
                            (ii) an amount equal to the sum of 
                        the respective amounts determined for 
                        the States under clause (i).
    (c) Disposition of Certain Funds Appropriated for 
Allotments.--
            (1) In general.--Amounts described in paragraph (2) 
        shall, in accordance with paragraph (3), be allotted by 
        the Secretary to States receiving payments under 
        section 1211(a) for the fiscal year (other than any 
        State referred to in paragraph (2)(C)).
            (2) Type of amounts.--The amounts referred to in 
        paragraph (1) are any amounts made available pursuant 
        to 1232(b)(3) that are not paid under section 1211(a) 
        to a State as a result of--
                    (A) the failure of the State to submit an 
                application under section 1217;
                    (B) the failure, in the determination of 
                the Secretary, of the State to prepare within a 
                reasonable period of time such application in 
                compliance with such section; or
                    (C) the State informing the Secretary that 
                the State does not intend to expend the full 
                amount of the allotment made for the State.
            (3) Amount.--The amount of an allotment under 
        paragraph (1) for a State for a fiscal year shall be an 
        amount equal to the product of--
                    (A) an amount equal to the amount described 
                in paragraph (2) for the fiscal year involved; 
                and
                    (B) the percentage determined under 
                subsection (b)(2) for the State.

SEC. 1219. [300D-19] FAILURE TO COMPLY WITH AGREEMENTS.

    (a) Repayment of Payments.--
            (1) Requirement.--The Secretary may, in accordance 
        with subsection (b), require a State to repay any 
        payments received by the State pursuant to section 
        1211(a) that the Secretary determines were not expended 
        by the State in accordance with the agreements required 
        to be made by the State as a condition of the receipt 
        of payments under such section.
            (2) Offset of amounts.--If a State fails to make a 
        repayment required in paragraph (1), the Secretary may 
        offset the amount of the repayment against any amount 
        due to be paid to the State under section 1211(a).
    (b) Opportunity for a Hearing.--Before requiring repayment 
of payments under subsection (a)(1), the Secretary shall 
provide to the State an opportunity for a hearing.

 H4  deg.SEC. 1220. [300D-20] PROHIBITION AGAINST CERTAIN 
                    FALSE STATEMENTS.

    (a) In General.--
            (1) False statements or representations.--A person 
        may not knowingly and willfully make or cause to be 
        made any false statement or representation of a 
        material fact in connection with the furnishing of 
        items or services for which payments may be made by a 
        State from amounts paid to the State under section 
        1211(a).
            (2) Concealing or failing to disclose 
        information.--A person with knowledge of the occurrence 
        of any event affecting the right of the person to 
        receive any payments from amounts paid to the State 
        under section 1211(a) may not conceal or fail to 
        disclose any such event with the intent of fraudulently 
        securing such amount.
    (b) Criminal Penalty for Violation of Prohibition.--Any 
person who violates a prohibition established in subsection (a) 
may for each violation be fined in accordance with title 18, 
United States Code, or imprisoned for not more than 5 years, or 
both.

 H4  deg.SEC. 1221. [300D-21] TECHNICAL ASSISTANCE AND 
                    PROVISION BY SECRETARY OF SUPPLIES AND SERVICES IN 
                    LIEU OF GRANT FUNDS.

    (a) Technical Assistance.--The Secretary shall, without 
charge to a State receiving payments under section 1211(a), 
provide to the State (or to any public or nonprofit private 
entity designated by the State) technical assistance with 
respect to the planning, development, and operation of any 
program carried out pursuant to section 1211(b). The Secretary 
may provide such technical assistance directly, through 
contract, or through grants.
    (b) Provision by Secretary of Supplies and Services in Lieu 
of Grant Funds.--
            (1) In general.--Upon the request of a State 
        receiving payments under section 1211(a), the Secretary 
        may, subject to paragraph (2), provide supplies, 
        equipment, and services for the purpose of aiding the 
        State in carrying out section 1211(b) and, for such 
        purpose, may detail to the State any officer or 
        employee of the Department of Health and Human 
        Services.
            (2) Reduction in payments.--With respect to a 
        request described in paragraph (1), the Secretary shall 
        reduce the amount of payments to the State under 
        section 1211(a) by an amount equal to the costs of 
        detailing personnel and the fair market value of any 
        supplies, equipment, or services provided by the 
        Secretary. The Secretary shall, for the payment of 
        expenses incurred in complying with such request, 
        expend the amounts withheld.

 H4  deg.SEC. 1222. [300D-22] REPORT BY SECRETARY.

    Not later than October 1, 2008, the Secretary shall report 
to the appropriate committees of Congress on the activities of 
the States carried out pursuant to section 1211. Such report 
shall include an assessment of the extent to which Federal and 
State efforts to develop systems of trauma care and to 
designate trauma centers have reduced the incidence of 
mortality, and the incidence of permanent disability, resulting 
from trauma. Such report may include any recommendations of the 
Secretary for appropriate administrative and legislative 
initiatives with respect to trauma care.

           Part C--General Provisions Regarding Parts A and B

SEC. 1231. [300D-31] DEFINITIONS.

    For purposes of this part and parts A and B:
            (1) Designated trauma center.--The term 
        ``designated trauma center'' means a trauma center 
        designated in accordance with the modifications to the 
        State plan described in section 1213.
            (2) State plan regarding emergency medical 
        services.--The term ``State plan'', with respect to the 
        provision of emergency medical services, means a plan 
        for a comprehensive, organized system to provide for 
        the access, response, triage, field stabilization, 
        transport, hospital stabilization, definitive care, and 
        rehabilitation of patients of all ages with respect to 
        emergency medical services.
            (3) State.--The term ``State'' means each of the 
        several States, the District of Columbia, the 
        Commonwealth of Puerto Rico, the Virgin Islands, Guam, 
        American Samoa, and the Commonwealth of the Northern 
        Mariana Islands.
            (4) Trauma.--The term ``trauma'' means an injury 
        resulting from exposure to a mechanical force.
            (5) Trauma care component of state plan.--The term 
        ``trauma care component'', with respect to components 
        of the State plan for the provision of emergency 
        medical services, means a plan for a comprehensive 
        health care system, within rural and urban areas of the 
        State, for the prompt recognition, prehospital care, 
        emergency medical care, acute surgical and medical 
        care, rehabilitation, and outcome evaluation of 
        seriously injured patients.

SEC. 1232. [300D-32] FUNDING.

    (a) Authorization of Appropriations.--For the purpose of 
carrying out parts A and B, subject to subsections (b) and (c), 
there are authorized to be appropriated $24,000,000 for each of 
fiscal years 2010 through 2014.
    (b) Reservation of Funds.--If the amount appropriated under 
subsection (a) for a fiscal year is equal to or less than 
$1,000,000, such appropriation is available only for the 
purpose of carrying out part A. If the amount so appropriated 
is greater than $1,000,000, 50 percent of such appropriation 
shall be made available for the purpose of carrying out part A 
and 50 percent shall be made available for the purpose of 
carrying out part B.
    (c) Allocation of Part A Funds.--Of the amounts 
appropriated under subsection (a) for a fiscal year to carry 
out part A--
            (1) 10 percent of such amounts for such year shall 
        be allocated for administrative purposes; and
            (2) 10 percent of such amounts for such year shall 
        be allocated for the purpose of carrying out section 
        1202.
    (d) Authority.--For the purpose of carrying out parts A 
through C, beginning on the date of enactment of the Patient 
Protection and Affordable Care Act, the Secretary shall 
transfer authority in administering grants and related 
authorities under such parts from the Administrator of the 
Health Resources and Services Administration to the Assistant 
Secretary for Preparedness and Response.

  Part D--Trauma Centers Operating in Areas Severely Affected by Drug-
                            Related Violence

 H4  deg.SEC. 1241. [300D-41] GRANTS FOR CERTAIN TRAUMA 
                    CENTERS.

    (a) In General.--The Secretary shall establish 3 programs 
to award grants to qualified public, nonprofit Indian Health 
Service, Indian tribal, and urban Indian trauma centers--
            (1) to assist in defraying substantial 
        uncompensated care costs;
            (2) to further the core missions of such trauma 
        centers, including by addressing costs associated with 
        patient stabilization and transfer, trauma education 
        and outreach, coordination with local and regional 
        trauma systems, essential personnel and other fixed 
        costs, and expenses associated with employee and non-
        employee physician services; and
            (3) to provide emergency relief to ensure the 
        continued and future availability of trauma services.
    (b) Minimum Qualifications of Trauma Centers.--
            (1) Participation in trauma care system operating 
        under certain professional guidelines.--Except as 
        provided in paragraph (2), the Secretary may not award 
        a grant to a trauma center under subsection (a) unless 
        the trauma center is a participant in a trauma system 
        that substantially complies with section 1213.
            (2) Exemption.--Paragraph (1) shall not apply to 
        trauma centers that are located in States with no 
        existing trauma care system.
            (3) Qualification for substantial uncompensated 
        care costs.--The Secretary shall award substantial 
        uncompensated care grants under subsection (a)(1) only 
        to trauma centers meeting at least 1 of the criteria in 
        1 of the following 3 categories:
                    (A) Category a.--The criteria for category 
                A are as follows:
                            (i) At least 40 percent of the 
                        visits in the emergency department of 
                        the hospital in which the trauma center 
                        is located were charity or self-pay 
                        patients.
                            (ii) At least 50 percent of the 
                        visits in such emergency department 
                        were Medicaid (under title XIX of the 
                        Social Security Act (42 U.S.C. 1396 et 
                        seq.)) and charity and self-pay 
                        patients combined.
                    (B) Category b.--The criteria for category 
                B are as follows:
                            (i) At least 35 percent of the 
                        visits in the emergency department were 
                        charity or self-pay patients.
                            (ii) At least 50 percent of the 
                        visits in the emergency department were 
                        Medicaid and charity and self-pay 
                        patients combined.
                    (C) Category c.--The criteria for category 
                C are as follows:
                            (i) At least 20 percent of the 
                        visits in the emergency department were 
                        charity or self-pay patients.
                            (ii) At least 30 percent of the 
                        visits in the emergency department were 
                        Medicaid and charity and self-pay 
                        patients combined.
            (4) Trauma centers in 1115 waiver states.--
        Notwithstanding paragraph (3), the Secretary may award 
        a substantial uncompensated care grant to a trauma 
        center under subsection (a)(1) if the trauma center 
        qualifies for funds under a Low Income Pool or Safety 
        Net Care Pool established through a waiver approved 
        under section 1115 of the Social Security Act (42 
        U.S.C. 1315).
            (5) Designation.--The Secretary may not award a 
        grant to a trauma center unless such trauma center is 
        verified by the American College of Surgeons or 
        designated by an equivalent State or local agency.
    (c) Additional Requirements.--The Secretary may not award a 
grant to a trauma center under subsection (a)(1) unless such 
trauma center--
            (1) submits to the Secretary a plan satisfactory to 
        the Secretary that demonstrates a continued commitment 
        to serving trauma patients regardless of their ability 
        to pay; and
            (2) has policies in place to assist patients who 
        cannot pay for part or all of the care they receive, 
        including a sliding fee scale, and to ensure fair 
        billing and collection practices.

 H4  deg.SEC. 1242. [300D-42] PREFERENCES IN MAKING GRANTS.

    (a) Substantial Uncompensated Care Awards.--
            (1) In general.--The Secretary shall establish an 
        award basis for each eligible trauma center for grants 
        under section 1241(a)(1) according to the percentage 
        described in paragraph (2), subject to the requirements 
        of section 1241(b)(3).
            (2) Percentages.--The applicable percentages are as 
        follows:
                    (A) With respect to a category A trauma 
                center, 100 percent of the uncompensated care 
                costs.
                    (B) With respect to a category B trauma 
                center, not more than 75 percent of the 
                uncompensated care costs.
                    (C) With respect to a category C trauma 
                center, not more than 50 percent of the 
                uncompensated care costs.
    (b) \1\ Core Mission Awards.--
---------------------------------------------------------------------------
    \1\ So in law. Subsection (b) includes a paragraph (1) but does not 
include subsequent paragaraphs.
---------------------------------------------------------------------------
            (1) In general.--In awarding grants under section 
        1241(a)(2), the Secretary shall--
                    (A) reserve 25 percent of the amount 
                allocated for core mission awards for Level III 
                and Level IV trauma centers; and
                    (B) reserve 25 percent of the amount 
                allocated for core mission awards for large 
                urban Level I and II trauma centers--
                            (i) that have at least 1 graduate 
                        medical education fellowship in trauma 
                        or trauma related specialties for which 
                        demand is exceeding supply;
                            (ii) for which--
                                    (I) annual uncompensated 
                                care costs exceed $10,000,000; 
                                or
                                    (II) at least 20 percent of 
                                emergency department visits are 
                                charity or self-pay or Medicaid 
                                patients; and
                            (iii) that are not eligible for 
                        substantial uncompensated care awards 
                        under section 1241(a)(1).
    (c) Emergency Awards.--In awarding grants under section 
1241(a)(3), the Secretary shall--
            (1) give preference to any application submitted by 
        a trauma center that provides trauma care in a 
        geographic area in which the availability of trauma 
        care has significantly decreased or will significantly 
        decrease if the center is forced to close or downgrade 
        service or growth in demand for trauma services exceeds 
        capacity; and
            (2) reallocate any emergency awards funds not 
        obligated due to insufficient, or a lack of qualified, 
        applications to the significant uncompensated care 
        award program.

 H4  deg.SEC. 1243. [300D-43] CERTAIN AGREEMENTS.

    (a) Maintenance of Financial Support.--The Secretary may 
require a trauma center receiving a grant under section 1241(a) 
to maintain access to trauma services at comparable levels to 
the prior year during the grant period.
    (b) Trauma Care Registry.--The Secretary may require the 
trauma center receiving a grant under section 1241(a) to 
provide data to a national and centralized registry of trauma 
cases, in accordance with guidelines developed by the American 
College of Surgeons, and as the Secretary may otherwise 
require.

 H4  deg.SEC. 1244. [300D-44] GENERAL PROVISIONS.

    (a) Application.--The Secretary may not award a grant to a 
trauma center under section 1241(a) unless such center submits 
an application for the grant to the Secretary and the 
application is in such form, is made in such manner, and 
contains such agreements, assurances, and information as the 
Secretary determines to be necessary to carry out this part.
    (b) Limitation on Duration of Support.--The period during 
which a trauma center receives payments under a grant under 
section 1241(a)(3) shall be for 3 fiscal years, except that the 
Secretary may waive such requirement for a center and authorize 
such center to receive such payments for 1 additional fiscal 
year.
    (c) Limitation on Amount of Grant.--Notwithstanding section 
1242(a), a grant under section 1241 may not be made in an 
amount exceeding $2,000,000 for each fiscal year.
    (d) Eligibility.--Except as provided in section 
1242(b)(1)(B)(iii), acquisition of, or eligibility for, a grant 
under section 1241(a) shall not preclude a trauma center from 
being eligible for other grants described in such section.
    (e) Funding Distribution.--Of the total amount appropriated 
for a fiscal year under section 1245, 70 percent shall be used 
for substantial uncompensated care awards under section 
1241(a)(1), 20 percent shall be used for core mission awards 
under section 1241(a)(2), and 10 percent shall be used for 
emergency awards under section 1241(a)(3).
    (f) Minimum Allowance.--Notwithstanding subsection (e), if 
the amount appropriated for a fiscal year under section 1245 is 
less than $25,000,000, all available funding for such fiscal 
year shall be used for substantial uncompensated care awards 
under section 1241(a)(1).
    (g) Substantial Uncompensated Care Award Distribution and 
Proportional Share.--Notwithstanding section 1242(a), of the 
amount appropriated for substantial uncompensated care grants 
for a fiscal year, the Secretary shall--
            (1) make available--
                    (A) 50 percent of such funds for category A 
                trauma center grantees;
                    (B) 35 percent of such funds for category B 
                trauma center grantees; and
                    (C) 15 percent of such funds for category C 
                trauma center grantees; and
            (2) provide available funds within each category in 
        a manner proportional to the award basis specified in 
        section 1242(a)(2) to each eligible trauma center.
    (h) Report.--Beginning 2 years after the date of enactment 
of the Patient Protection and Affordable Care Act, and every 2 
years thereafter, the Secretary shall biennially report to 
Congress regarding the status of the grants made under section 
1241 and on the overall financial stability of trauma centers.

SEC. 1245. [300D-45] AUTHORIZATION OF APPROPRIATIONS.

    For the purpose of carrying out this part, there are 
authorized to be appropriated $100,000,000 for fiscal year 
2009, and such sums as may be necessary for each of fiscal 
years 2010 through 2015. Such authorization of appropriations 
is in addition to any other authorization of appropriations or 
amounts that are available for such purpose.

SEC. 1246. [300D-46] DEFINITION.

    In this part, the term ``uncompensated care costs'' means 
unreimbursed costs from serving self-pay, charity, or Medicaid 
patients, without regard to payment under section 1923 of the 
Social Security Act, all of which are attributable to emergency 
care and trauma care, including costs related to subsequent 
inpatient admissions to the hospital.

                   Part E--Miscellaneous Programs \1\

SEC. 1251. [300D-51] RESIDENCY TRAINING PROGRAMS IN EMERGENCY MEDICINE.

    (a) In General.--The Secretary may make grants to public 
and nonprofit private entities for the purpose of planning and 
developing approved residency training programs in emergency 
medicine.
    (b) Identification and Referral of Domestic Violence.--The 
Secretary may make a grant under subsection (a) only if the 
applicant involved agrees that the training programs under 
subsection (a) will provide education and training in 
identifying and referring cases of domestic violence.
    (c) Authorization of Appropriations.--For the purpose of 
carrying out this section, there is authorized to be 
appropriated $400,000 for each of the fiscal years 2008 though 
2012.

SEC. 1252. [300D-52] STATE GRANTS FOR PROJECTS REGARDING TRAUMATIC 
                    BRAIN INJURY.

    (a) In General.--The Secretary, acting through the 
Administrator of the Health Resources and Services 
Administration, may make grants to States and American Indian 
consortia for the purpose of carrying out projects to improve 
access to rehabilitation and other services regarding traumatic 
brain injury.
    (b) State Advisory Board.--
            (1) In general.--The Secretary may make a grant 
        under subsection (a) only if the State or American 
        Indian consortium involved agrees to establish an 
        advisory board within the appropriate health department 
        of the State or American Indian consortium or within 
        another department as designated by the chief executive 
        officer of the State or American Indian consortium.
            (2) Functions.--An advisory board established under 
        paragraph (1) shall advise and make recommendations to 
        the State or American Indian consortium on ways to 
        improve services coordination regarding traumatic brain 
        injury. Such advisory boards shall encourage citizen 
        participation through the establishment of public 
        hearings and other types of community outreach 
        programs. In developing recommendations under this 
        paragraph, such boards shall consult with Federal, 
        State, and local governmental agencies and with 
        citizens groups and other private entities.
            (3) Composition.--An advisory board established 
        under paragraph (1) shall be composed of--
                    (A) representatives of--
                            (i) the corresponding State or 
                        American Indian consortium agencies 
                        involved;
                            (ii) public and nonprofit private 
                        health related organizations;
                            (iii) other disability advisory or 
                        planning groups within the State or 
                        American Indian consortium;
                            (iv) members of an organization or 
                        foundation representing individuals 
                        with traumatic brain injury in that 
                        State or American Indian consortium; 
                        and
                            (v) injury control programs at the 
                        State or local level if such programs 
                        exist; and
                    (B) a substantial number of individuals 
                with traumatic brain injury, or the family 
                members of such individuals.
    (c) Matching Funds.--
            (1) In general.--With respect to the costs to be 
        incurred by a State or American Indian consortium in 
        carrying out the purpose described in subsection (a), 
        the Secretary may make a grant under such subsection 
        only if the State or American Indian consortium agrees 
        to make available non-Federal contributions toward such 
        costs in an amount that is not less than $1 for each $2 
        of Federal funds provided under the grant.
            (2) Determination of amount contributed.--Non-
        Federal contributions under paragraph (1) may be in 
        cash or in kind, fairly evaluated, including plant, 
        equipment, or services. Amounts provided by the Federal 
        Government, or services assisted or subsidized to any 
        significant extent by the Federal Government, may not 
        be included in determining the amount of such 
        contributions.
    (d) Application for Grant.--The Secretary may make a grant 
under subsection (a) only if an application for the grant is 
submitted to the Secretary and the application is in such form, 
is made in such manner, and contains such agreements, 
assurances, and information as the Secretary determines to be 
necessary to carry out this section.
    (e) Continuation of Previously Awarded Demonstration 
Projects.--A State or American Indian consortium that received 
a grant under this section prior to the date of the enactment 
of the Traumatic Brain Injury Act of 2008 may complete the 
activities funded by the grant.
    (f) Use of State and American Indian Consortium Grants.--
            (1) Community services and supports.--A State or 
        American Indian consortium shall (directly or through 
        awards of contracts to nonprofit private entities) use 
        amounts received under a grant under this section for 
        the following:
                    (A) To develop, change, or enhance 
                community-based service delivery systems that 
                include timely access to comprehensive 
                appropriate services and supports. Such service 
                and supports--
                            (i) shall promote full 
                        participation by individuals with brain 
                        injury and their families in decision 
                        making regarding the services and 
                        supports; and
                            (ii) shall be designed for 
                        children, youth, and adults with 
                        traumatic brain injury.
                    (B) To focus on outreach to underserved and 
                inappropriately served individuals, such as 
                individuals in institutional settings, 
                individuals with low socioeconomic resources, 
                individuals in rural communities, and 
                individuals in culturally and linguistically 
                diverse communities.
                    (C) To award contracts to nonprofit 
                entities for consumer or family service access 
                training, consumer support, peer mentoring, and 
                parent to parent programs.
                    (D) To develop individual and family 
                service coordination or case management 
                systems.
                    (E) To support other needs identified by 
                the advisory board under subsection (b) for the 
                State or American Indian consortium involved.
            (2) Best practices.--
                    (A) In general.--State or American Indian 
                consortium services and supports provided under 
                a grant under this section shall reflect the 
                best practices in the field of traumatic brain 
                injury, shall be in compliance with title II of 
                the Americans with Disabilities Act of 1990, 
                and shall be supported by quality assurance 
                measures as well as state-of-the-art health 
                care and integrated community supports, 
                regardless of the severity of injury.
                    (B) Demonstration by state agency.--The 
                State or American Indian consortium agency 
                responsible for administering amounts received 
                under a grant under this section shall 
                demonstrate that it has obtained knowledge and 
                expertise of traumatic brain injury and the 
                unique needs associated with traumatic brain 
                injury.
            (3) State capacity building.--A State or American 
        Indian consortium may use amounts received under a 
        grant under this section to--
                    (A) educate consumers and families;
                    (B) train professionals in public and 
                private sector financing (such as third party 
                payers, State agencies, community-based 
                providers, schools, and educators);
                    (C) develop or improve case management or 
                service coordination systems;
                    (D) develop best practices in areas such as 
                family or consumer support, return to work, 
                housing or supportive living personal 
                assistance services, assistive technology and 
                devices, behavioral health services, substance 
                abuse services, and traumatic brain injury 
                treatment and rehabilitation;
                    (E) tailor existing State or American 
                Indian consortium systems to provide 
                accommodations to the needs of individuals with 
                brain injury (including systems administered by 
                the State or American Indian consortium 
                departments responsible for health, mental 
                health, labor/employment, education, mental 
                retardation /developmental disorders, 
                transportation, and correctional systems);
                    (F) improve data sets coordinated across 
                systems and other needs identified by a State 
                or American Indian consortium plan supported by 
                its advisory council; and
                    (G) develop capacity within targeted 
                communities.
    (g) Coordination of Activities.--The Secretary shall ensure 
that activities under this section are coordinated as 
appropriate with other Federal agencies that carry out 
activities regarding traumatic brain injury.
    (h) Report.--Not less than biennially, the Secretary shall 
submit to the Committee on Energy and Commerce of the House of 
Representatives, and to the Committee on Health, Education, 
Labor, and Pensions of the Senate, a report describing the 
findings and results of the programs established under this 
section, \1\ and section 1253 including measures of outcomes 
and consumer and surrogate satisfaction.
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    \1\ The comma after ``this section'' probably should be moved to 
follow the reference to ``section 1253''.
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    (i) Definitions.--For purposes of this section:
            (1) The terms ``American Indian consortium'' and 
        ``State'' have the meanings given to those terms in 
        section 1253.
            (2) The term ``traumatic brain injury'' means an 
        acquired injury to the brain. Such term does not 
        include brain dysfunction caused by congenital or 
        degenerative disorders, nor birth trauma, but may 
        include brain injuries caused by anoxia due to trauma. 
        The Secretary may revise the definition of such term as 
        the Secretary determines necessary, after consultation 
        with States and other appropriate public or nonprofit 
        private entities.
    (j) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2001 through 2005, and such sums as may be 
necessary for each of the fiscal years 2009 through 2012.

SEC. 1253. [300D-53] STATE GRANTS FOR PROTECTION AND ADVOCACY SERVICES.

    (a) In General.--The Secretary, acting through the 
Administrator of the Health Resources and Services 
Administration (referred to in this section as the 
``Administrator''), shall make grants to protection and 
advocacy systems for the purpose of enabling such systems to 
provide services to individuals with traumatic brain injury.
    (b) Services Provided.--Services provided under this 
section may include the provision of--
            (1) information, referrals, and advice;
            (2) individual and family advocacy;
            (3) legal representation; and
            (4) specific assistance in self-advocacy.
    (c) Application.--To be eligible to receive a grant under 
this section, a protection and advocacy system shall submit an 
application to the Administrator at such time, in such form and 
manner, and accompanied by such information and assurances as 
the Administrator may require.
    (d) Appropriations Less Than $2,700,000.--
            (1) In general.--With respect to any fiscal year in 
        which the amount appropriated under subsection (l) to 
        carry out this section is less than $2,700,000, the 
        Administrator shall make grants from such amount to 
        individual protection and advocacy systems within 
        States to enable such systems to plan for, develop 
        outreach strategies for, and carry out services 
        authorized under this section for individuals with 
        traumatic brain injury.
            (2) Amount.--The amount of each grant provided 
        under paragraph (1) shall be determined as set forth in 
        paragraphs (2) and (3) of subsection (e).
    (e) Appropriations of $2,700,000 or More.--
            (1) Population basis.--Except as provided in 
        paragraph (2), with respect to each fiscal year in 
        which the amount appropriated under subsection (l) to 
        carry out this section is $2,700,000 or more, the 
        Administrator shall make a grant to a protection and 
        advocacy system within each State.
            (2) Amount.--The amount of a grant provided to a 
        system under paragraph (1) shall be equal to an amount 
        bearing the same ratio to the total amount appropriated 
        for the fiscal year involved under subsection (l) as 
        the population of the State in which the grantee is 
        located bears to the population of all States.
            (3) Minimums.--Subject to the availability of 
        appropriations, the amount of a grant a protection and 
        advocacy system under paragraph (1) for a fiscal year 
        shall--
                    (A) in the case of a protection and 
                advocacy system located in American Samoa, 
                Guam, the United States Virgin Islands, or the 
                Commonwealth of the Northern Mariana Islands, 
                and the protection and advocacy system serving 
                the American Indian consortium, not be less 
                than $20,000; and
                    (B) in the case of a protection and 
                advocacy system in a State not described in 
                subparagraph (A), not be less than $50,000.
            (4) Inflation adjustment.--For each fiscal year in 
        which the total amount appropriated under subsection 
        (l) to carry out this section is $5,000,000 or more, 
        and such appropriated amount exceeds the total amount 
        appropriated to carry out this section in the preceding 
        fiscal year, the Administrator shall increase each of 
        the minimum grants amount described in subparagraphs 
        (A) and (B) of paragraph (3) by a percentage equal to 
        the percentage increase in the total amount 
        appropriated under subsection (l) to carry out this 
        section between the preceding fiscal year and the 
        fiscal year involved.
    (f) Carryover.--Any amount paid to a protection and 
advocacy system that serves a State or the American Indian 
consortium for a fiscal year under this section that remains 
unobligated at the end of such fiscal year shall remain 
available to such system for obligation during the next fiscal 
year for the purposes for which such amount was originally 
provided.
    (g) Direct Payment.--Notwithstanding any other provision of 
law, each fiscal year not later than October 1, the 
Administrator shall pay directly to any protection and advocacy 
system that complies with the provisions of this section, the 
total amount of the grant for such system, unless the system 
provides otherwise for such payment.
    (h) Annual Report.--Each protection and advocacy system 
that receives a payment under this section shall submit an 
annual report to the Administrator concerning the services 
provided to individuals with traumatic brain injury by such 
system.
    (i) Data Collection.--The Administrator of the Health 
Resources and Services Administration and the Commissioner of 
the Administration on Developmental Disabilities shall enter 
into an agreement to coordinate the collection of data by the 
Administrator and the Commissioner regarding protection and 
advocacy services.
    (j) Training and Technical Assistance.--
            (1) Grants.--For any fiscal year for which the 
        amount appropriated to carry out this section is 
        $6,000,000 or greater, the Administrator shall use 2 
        percent of such amount to make a grant to an eligible 
        national association for providing for training and 
        technical assistance to protection and advocacy 
        systems.
            (2) Definition.--In this subsection, the term 
        ``eligible national association'' means a national 
        association with demonstrated experience in providing 
        training and technical assistance to protection and 
        advocacy systems.
    (k) System Authority.--In providing services under this 
section, a protection and advocacy system shall have the same 
authorities, including access to records, as such system would 
have for purposes of providing services under subtitle C of the 
Developmental Disabilities Assistance and Bill of Rights Act of 
2000 \1\.
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    \1\ The reference to subtitle C of the Developmental Disabilities 
Assistance and Bill of Rights Act of 2000 should refer to subtitle C of 
``title I'' of such Act.
---------------------------------------------------------------------------
    (l) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section $5,000,000 for 
fiscal year 2001, and such sums as may be necessary for each 
the fiscal years 2009 through 2012.
    (m) Definitions.--In this section:
            (1) American indian consortium.--The term 
        ``American Indian consortium'' means a consortium 
        established under part C of the Developmental 
        Disabilities Assistance Bill of Rights Act (42 U.S.C. 
        6042 et seq.).
            (2) Protection and advocacy system.--The term 
        ``protection and advocacy system'' means a protection 
        and advocacy system established under part C of the 
        Developmental Disabilities Assistance and Bill of 
        Rights Act (42 U.S.C. 6042 et seq.).
            (3) State.--The term ``State'', unless otherwise 
        specified, means the several States of the United 
        States, the District of Columbia, the Commonwealth of 
        Puerto Rico, the United States Virgin Islands, Guam, 
        American Samoa, and the Commonwealth of the Northern 
        Mariana Islands.

            Part F--Interagency Program for Trauma Research

SEC. 1261. [300D-61] ESTABLISHMENT OF PROGRAM.

    (a) In General.--The Secretary, acting through the Director 
of the National Institutes of Health (in this section referred 
to as the ``Director''), shall establish a comprehensive 
program of conducting basic and clinical research on trauma (in 
this section referred to as the ``Program''). The Program shall 
include research regarding the diagnosis, treatment, 
rehabilitation, and general management of trauma.
    (b) Plan for Program.--
            (1) In general.--The Director, in consultation with 
        the Trauma Research Interagency Coordinating Committee 
        established under subsection (g), shall establish and 
        implement a plan for carrying out the activities of the 
        Program, including the activities described in 
        subsection (d). All such activities shall be carried 
        out in accordance with the plan. The plan shall be 
        periodically reviewed, and revised as appropriate.
            (2) Submission to congress.--Not later than 
        December 1, 1993, the Director shall submit the plan 
        required in paragraph (1) to the Committee on Energy 
        and Commerce of the House of Representatives, and to 
        the Committee on Health, Education, Labor, and Pensions 
        of the Senate, together with an estimate of the funds 
        needed for each of the fiscal years 1994 through 1996 
        to implement the plan.
    (c) Participating Agencies; Coordination and 
Collaboration.--The Director--
            (1) shall provide for the conduct of activities 
        under the Program by the Directors of the agencies of 
        the National Institutes of Health involved in research 
        with respect to trauma;
            (2) shall ensure that the activities of the Program 
        are coordinated among such agencies; and
            (3) shall, as appropriate, provide for 
        collaboration among such agencies in carrying out such 
        activities.
    (d) Certain Activities of Program.--The Program shall 
include--
            (1) studies with respect to all phases of trauma 
        care, including prehospital, resuscitation, surgical 
        intervention, critical care, infection control, wound 
        healing, nutritional care and support, and medical 
        rehabilitation care;
            (2) basic and clinical research regarding the 
        response of the body to trauma and the acute treatment 
        and medical rehabilitation of individuals who are the 
        victims of trauma;
            (3) basic and clinical research regarding trauma 
        care for pediatric and geriatric patients; and
            (4) the authority to make awards of grants or 
        contracts to public or nonprofit private entities for 
        the conduct of basic and applied research regarding 
        traumatic brain injury, which research may include--
                    (A) the development of new methods and 
                modalities for the more effective diagnosis, 
                measurement of degree of brain injury, post-
                injury monitoring and prognostic assessment of 
                head injury for acute, subacute and later 
                phases of care;
                    (B) the development, modification and 
                evaluation of therapies that retard, prevent or 
                reverse brain damage after acute head injury 
                \1\, that arrest further deterioration 
                following injury and that provide the 
                restitution of function for individuals with 
                long-term injuries;
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    \1\ Section 1303(a)(2) of Public Law 106-310 (114 Stat. 1138) 
provides that subparagraph (B) is amended by striking ``acute injury'' 
and inserting ``acute brain injury''. The amendment cannot be executed 
because the term to be struck does not appear in subparagraph (B). 
(Compare ``acute injury'' and ``acute head injury''.)
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                    (C) the development of research on a 
                continuum of care from acute care through 
                rehabilitation, designed, to the extent 
                practicable, to integrate rehabilitation and 
                long-term outcome evaluation with acute care 
                research;
                    (D) the development of programs that 
                increase the participation of academic centers 
                of excellence in brain injury treatment and 
                rehabilitation research and training; and
                    (E) carrying out subparagraphs (A) through 
                (D) with respect to cognitive disorders and 
                neurobehavioral consequences arising from 
                traumatic brain injury, including the 
                development, modification, and evaluation of 
                therapies and programs of rehabilitation toward 
                reaching or restoring normal capabilities in 
                areas such as reading, comprehension, speech, 
                reasoning, and deduction.
    (e) Mechanisms of Support.--In carrying out the Program, 
the Director, acting through the Directors of the agencies 
referred to in subsection (c)(1), may make grants to public and 
nonprofit entities, including designated trauma centers.
    (f) Resources.--The Director shall assure the availability 
of appropriate resources to carry out the Program, including 
the plan established under subsection (b) (including the 
activities described in subsection (d)).
    (g) Coordinating Committee.--
            (1) In general.--There shall be established a 
        Trauma Research Interagency Coordinating Committee (in 
        this section referred to as the ``Coordinating 
        Committee'').
            (2) Duties.--The Coordinating Committee shall make 
        recommendations regarding--
                    (A) the activities of the Program to be 
                carried out by each of the agencies represented 
                on the Committee and the amount of funds needed 
                by each of the agencies for such activities; 
                and
                    (B) effective collaboration among the 
                agencies in carrying out the activities.
            (3) Composition.--The Coordinating Committee shall 
        be composed of the Directors of each of the agencies 
        that, under subsection (c), have responsibilities under 
        the Program, and any other individuals who are 
        practitioners in the trauma field as designated by the 
        Director of the National Institutes of Health.
    (h) Definitions.--For purposes of this section:
            (1) The term ``designated trauma center'' has the 
        meaning given such term in section 1231(1).
            (2) The term ``Director'' means the Director of the 
        National Institutes of Health.
            (3) The term ``trauma'' means any serious injury 
        that could result in loss of life or in significant 
        disability and that would meet pre-hospital triage 
        criteria for transport to a designated trauma center.
            (4) The term ``traumatic brain injury'' means an 
        acquired injury to the brain. Such term does not 
        include brain dysfunction caused by congenital or 
        degenerative disorders, nor birth trauma, but may 
        include brain injuries caused by anoxia due to trauma. 
        The Secretary may revise the definition of such term as 
        the Secretary determines necessary, after consultation 
        with States and other appropriate public or nonprofit 
        private entities.
    (i) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2001 through 2005, and such sums as may be 
necessary for each of the fiscal years 2009 through 2012.

                         Part G--Poison Control

SEC. 1271. [300D-71] MAINTENANCE OF THE NATIONAL TOLL-FREE NUMBER.

    (a) In General.--The Secretary shall provide coordination 
and assistance to poison control centers for the establishment 
of a nationwide toll-free phone number, and the maintenance of 
such number, to be used to access such centers.
    (b) Authorization of Appropriations.--There is authorized 
to be appropriated $2,000,000 for fiscal year 2009 to carry out 
this section, and $700,000 for each of fiscal years 2010 
through 2014 for the maintenance of the nationwide toll free 
phone number under subsection (a).

SEC. 1272. [300D-72] NATIONWIDE MEDIA CAMPAIGN TO PROMOTE POISON 
                    CONTROL CENTER UTILIZATION.

    (a) In General.--The Secretary shall carry out, and expand 
upon, a national media campaign to educate the public and 
health care providers about poison prevention and the 
availability of poison control center resources in local 
communities and to conduct advertising campaigns concerning the 
nationwide toll-free number established under section 1271(a).
    (b) Contract With Entity.--The Secretary may carry out 
subsection (a) by entering into contracts with one or more 
public or private entities, including nationally recognized 
organizations in the field of poison control and national media 
firms, for the development and implementation of a nationwide 
poison prevention and poison control center awareness campaign, 
which may include--
            (1) the development and distribution of poison 
        prevention and poison control center awareness 
        materials;
            (2) television, radio, Internet, and newspaper 
        public service announcements; and
            (3) other activities to provide for public and 
        professional awareness and education.
    (c) Evaluation.--The Secretary shall--
            (1) establish baseline measures and benchmarks to 
        quantitatively evaluate the impact of the nationwide 
        media campaign carried out under this section; and
            (2) on an annual basis, prepare and submit to the 
        appropriate committees of Congress, \1\ an evaluation 
        of the nationwide media campaign.
---------------------------------------------------------------------------
    \1\ The comma after ``Congress'' probably should not appear.
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    (d) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section, such sums as may 
be necessary for fiscal year 2009, and $800,000 for each of 
fiscal years 2010 through 2014.

SEC. 1273. [300D-73] MAINTENANCE OF THE POISON CONTROL CENTER GRANT 
                    PROGRAM.

    (a) Authorization of Program.--The Secretary shall award 
grants to poison control centers certified under subsection (c) 
(or granted a waiver under subsection (d)) and professional 
organizations in the field of poison control for the purposes 
of preventing, and providing treatment recommendations for, 
poisonings and complying with the operational requirements 
needed to sustain the certification of the center under 
subsection (c).
    (b) Additional Uses of Funds.--In addition to the purposes 
described in subsection (a), a poison center or professional 
organization awarded a grant, contract, or cooperative 
agreement under such subsection may also use amounts received 
under such grant, contract, or cooperative agreement--
            (1) to establish and evaluate best practices in the 
        United States for poison prevention, poison control 
        center outreach, and emergency and preparedness 
        programs;
            (2) to research, develop, implement, revise, and 
        communicate standard patient management guidelines for 
        commonly encountered toxic exposures;
            (3) to improve national toxic exposure surveillance 
        by enhancing cooperative activities between poison 
        control centers in the United States and the Centers 
        for Disease Control and Prevention;
            (4) to develop, support, and enhance technology and 
        capabilities of professional organizations in the field 
        of poison control to collect national poisoning, toxic 
        occurrence, and related public health data;
            (5) to develop initiatives to foster the enhanced 
        public health utilization of national poison data 
        collected by organizations described in paragraph (4);
            (6) to support and expand the toxicologic expertise 
        within poison control centers; and
            (7) to improve the capacity of poison control 
        centers to answer high volumes of calls and respond 
        during times of national crisis or other public health 
        emergencies.
    (c) Certification.--Except as provided in subsection (d), 
the Secretary may award a grant to a poison control center 
under subsection (a) only if--
            (1) the center has been certified by a professional 
        organization in the field of poison control, and the 
        Secretary has approved the organization as having in 
        effect standards for certification that reasonably 
        provide for the protection of the public health with 
        respect to poisoning; or
            (2) the center has been certified by a State 
        government, and the Secretary has approved the State 
        government as having in effect standards for 
        certification that reasonably provide for the 
        protection of the public health with respect to 
        poisoning.
    (d) Waiver of Certification Requirements.--
            (1) In general.--The Secretary may grant a waiver 
        of the certification requirements of subsection (c) 
        with respect to a noncertified poison control center 
        that applies for a grant under this section if such 
        center can reasonably demonstrate that the center will 
        obtain such a certification within a reasonable period 
        of time as determined appropriate by the Secretary.
            (2) Renewal.--The Secretary may renew a waiver 
        under paragraph (1).
            (3) Limitation.--In no case may the sum of the 
        number of years for a waiver under paragraph (1) and a 
        renewal under paragraph (2) exceed 5 years. The 
        preceding sentence shall take effect as of the date of 
        the enactment of the Poison Center Support, 
        Enhancement, and Awareness Act of 2008.
    (e) Supplement Not Supplant.--Amounts made available to a 
poison control center under this section shall be used to 
supplement and not supplant other Federal, State or local funds 
provided for such center.
    (f) Maintenance of Effort.--A poison control center, in 
utilizing the proceeds of a grant under this section, shall 
maintain the expenditures of the center for activities of the 
center at a level that is not less than the level of 
expenditures maintained by the center for the fiscal year 
preceding the fiscal year for which the grant is received.
    (g) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section, $27,500,000 for 
fiscal year 2009, and $28,600,000 for each of fiscal years 2010 
through 2014. The Secretary may utilize not to exceed 8 percent 
of the amount appropriated under this preceding sentence in 
each fiscal year for coordination, dissemination, technical 
assistance, program evaluation, data activities, and other 
program administration functions that do not include grants, 
contracts, or cooperative agreements under subsections (a) and 
(b), which are determined by the Secretary to be appropriate 
for carrying out the program under this section.

SEC. 1274. [300D-74] RULE OF CONSTRUCTION.

    Nothing in this part may be construed to ease any 
restriction in Federal law applicable to the amount or 
percentage of funds appropriated to carry out this part that 
may be used to prepare or submit a report.

                  PART H--TRAUMA SERVICE AVAILABILITY

SEC. 1281. [300D-81] GRANTS TO STATES.

    (a) Establishment.--To promote universal access to trauma 
care services provided by trauma centers and trauma-related 
physician specialties, the Secretary shall provide funding to 
States to enable such States to award grants to eligible 
entities for the purposes described in this section.
    (b) Awarding of Grants by States.--Each State may award 
grants to eligible entities within the State for the purposes 
described in subparagraph (d).
    (c) Eligibility.--
            (1) In general.--To be eligible to receive a grant 
        under subsection (b) an entity shall--
                    (A) be--
                            (i) a public or nonprofit trauma 
                        center or consortium thereof that meets 
                        that requirements of paragraphs (1), 
                        (2), and (5) of section 1241(b);
                            (ii) a safety net public or 
                        nonprofit trauma center that meets the 
                        requirements of paragraphs (1) through 
                        (5) of section 1241(b); or
                            (iii) a hospital in an underserved 
                        area (as defined by the State) that 
                        seeks to establish new trauma services; 
                        and
                    (B) submit to the State an application at 
                such time, in such manner, and containing such 
                information as the State may require.
            (2) Limitation.--A State shall use at least 40 
        percent of the amount available to the State under this 
        part for a fiscal year to award grants to safety net 
        trauma centers described in paragraph (1)(A)(ii).
    (d) Use of Funds.--The recipient of a grant under 
subsection (b) shall carry out 1 or more of the following 
activities consistent with subsection (b):
            (1) Providing trauma centers with funding to 
        support physician compensation in trauma-related 
        physician specialties where shortages exist in the 
        region involved, with priority provided to safety net 
        trauma centers described in subsection (c)(1)(A)(ii).
            (2) Providing for individual safety net trauma 
        center fiscal stability and costs related to having 
        service that is available 24 hours a day, 7 days a 
        week, with priority provided to safety net trauma 
        centers described in subsection (c)(1)(A)(ii) located 
        in urban, border, and rural areas.
            (3) Reducing trauma center overcrowding at specific 
        trauma centers related to throughput of trauma 
        patients.
            (4) Establishing new trauma services in underserved 
        areas as defined by the State.
            (5) Enhancing collaboration between trauma centers 
        and other hospitals and emergency medical services 
        personnel related to trauma service availability.
            (6) Making capital improvements to enhance access 
        and expedite trauma care, including providing helipads 
        and associated safety infrastructure.
            (7) Enhancing trauma surge capacity at specific 
        trauma centers.
            (8) Ensuring expedient receipt of trauma patients 
        transported by ground or air to the appropriate trauma 
        center.
            (9) Enhancing interstate trauma center 
        collaboration.
    (e) Limitation.--
            (1) In general.--A State may use not more than 20 
        percent of the amount available to the State under this 
        part for a fiscal year for administrative costs 
        associated with awarding grants and related costs.
            (2) Maintenance of effort.--The Secretary may not 
        provide funding to a State under this part unless the 
        State agrees that such funds will be used to supplement 
        and not supplant State funding otherwise available for 
        the activities and costs described in this part.
    (f) Distribution of Funds.--The following shall apply with 
respect to grants provided in this part:
            (1) Less than $10,000,000.--If the amount of 
        appropriations for this part in a fiscal year is less 
        than $10,000,000, the Secretary shall divide such 
        funding evenly among only those States that have 1 or 
        more trauma centers eligible for funding under section 
        1241(b)(3)(A).
            (2) Less than $20,000,000.--If the amount of 
        appropriations in a fiscal year is less than 
        $20,000,000, the Secretary shall divide such funding 
        evenly among only those States that have 1 or more 
        trauma centers eligible for funding under subparagraphs 
        (A) and (B) of section 1241(b)(3).
            (3) Less than $30,000,000.--If the amount of 
        appropriations for this part in a fiscal year is less 
        than $30,000,000, the Secretary shall divide such 
        funding evenly among only those States that have 1 or 
        more trauma centers eligible for funding under section 
        1241(b)(3).
            (4) $30,000,000 or more.--If the amount of 
        appropriations for this part in a fiscal year is 
        $30,000,000 or more, the Secretary shall divide such 
        funding evenly among all States.

SEC. 1282. [300D-82] AUTHORIZATION OF APPROPRIATIONS.

    For the purpose of carrying out this part, there is 
authorized to be appropriated $100,000,000 for each of fiscal 
years 2010 through 2015.ATTORNEY: pmg/FD (June 28, 
1999) deg.
              TITLE XIII--HEALTH MAINTENANCE ORGANIZATIONS

           requirements for health maintenance organizations

    Sec. 1301. [300e] (a) For purposes of this title, the term 
``health maintenance organization'' means a public or private 
entity which is organized under the laws of any State and which 
(1) provides basic and supplemental health services to its 
members in the manner prescribed by subsection (b), and (2) is 
organized and operated in the manner prescribed by subsection 
(c).
    (b) A health maintenance organization shall provide, 
without limitations as to time or cost other than those 
prescribed by or under this title, basic and supplemental 
health services to its members in the following manner:
            (1) Each member is to be provided basic health 
        services for a basic health services payment which (A) 
        is to be paid on a periodic basis without regard to the 
        dates health services (within the basic health 
        services) are provided; (B) is fixed without regard to 
        the frequency, extent, or kind of health service 
        (within the basic health services) actually furnished; 
        (C) except in the case of basic health services 
        provided a member who is a full-time student (as 
        defined by the Secretary) at an accredited institution 
        of higher education, is fixed under a community rating 
        system; and (D) may be supplemented by additional 
        nominal payments which may be required for the 
        provision of specific services (within the basic health 
        services), except that such payments may not be 
        required where or in such a manner that they serve (as 
        determined under regulations of the Secretary) as a 
        barrier to the delivery of health services. Such 
        additional nominal payments shall be fixed in 
        accordance with the regulations of the Secretary. If a 
        health maintenance organization offers to its members 
        the opportunity to obtain basic health services through 
        a physician not described in subsection (b)(3)(A), the 
        organization may require, in addition to payments 
        described in clause (D) of this paragraph, a reasonable 
        deductible to be paid by a member when obtaining a 
        basic health service from such a physician. A health 
        maintenance organization may include a health service, 
        defined as a supplemental health service by section 
        1302(2), in the basic health services provided its 
        members for a basic health services payment described 
        in the first sentence. In the case of an entity which 
        before it became a qualified health maintenance 
        organization (within the meaning of section 1310(d)) 
        provided comprehensive health services on a prepaid 
        basis, the requirement of clause (C) shall not apply to 
        such entity until the expiration of the forty-eight 
        month period beginning with the month following the 
        month in which the entity became such a qualified 
        health organization. The requirements of this paragraph 
        respecting the basic health services payment shall not 
        apply to the provision of basic health services to a 
        member for an illness or injury for which the member is 
        entitled to benefits under a workmen's compensation law 
        or an insurance policy but only to the extent such 
        benefits apply to such services. For the provision of 
        such services for an illness or injury for which a 
        member is entitled to benefits under such a law, the 
        health maintenance organization may, if authorized by 
        such law, charge or authorize the provider of such 
        services to charge, in accordance with the charges 
        allowed under such law, the insurance carrier, 
        employer, or other entity which under such law is to 
        pay for the provision of such services or, to the 
        extent that such member has been paid under such law 
        for such services, such member. For the provision of 
        such services for an illness or injury for which a 
        member is entitled to benefits under an insurance 
        policy, a health maintenance organization may charge or 
        authorize the provider of such services to charge the 
        insurance carrier under such policy or, to the extent 
        that such member has been paid under such policy for 
        such services, such member.
            (2) For such payment or payments (hereinafter in 
        this title referred to as ``supplemental health 
        services payments'') as the health maintenance 
        organization may require in addition to the basic 
        health services payment, the organization may provide 
        to each of its members any of the health services which 
        are included in supplemental health services (as 
        defined in section 1302(2)). Supplemental health 
        services payments which are fixed on a prepayment basis 
        shall be fixed under a community rating system unless 
        the supplemental health services payment is for a 
        supplemental health service provided a member who is a 
        full-time student (as defined by the Secretary) at an 
        accredited institution of higher education, except 
        that, in the case of an entity which before it became a 
        qualified health maintenance organization (within the 
        meaning of section 1310(d)) provided comprehensive 
        health services on a prepaid basis, the requirement of 
        this sentence shall not apply to such entity during the 
        forty-eight month period beginning with the month 
        following the month in which the entity became such a 
        qualified health maintenance organization.
            (3)(A) Except as provided in subparagraph (B), at 
        least 90 percent of the services of a physician which 
        are provided as basic health services shall be provided 
        through--
                    (i) members of the staff of the health 
                maintenance organization,
                    (ii) a medical group (or groups),
                    (iii) an individual practice association 
                (or associations),
                    (iv) physicians or other health 
                professionals who have contracted with the 
                health maintenance organization for the 
                provision of such services, or
                    (v) any combination of such staff, medical 
                group (or groups), individual practice 
                association (or associations) or physicians or 
                other health professionals under contract with 
                the organization.
            (B) Subparagraph (A) does not apply to the 
        provision of the services of a physician--
                    (i) which the health maintenance 
                organization determines, in conformity with 
                regulations of the Secretary, are unusual or 
                infrequently used, or
                    (ii) which are provided a member of the 
                organization in a manner other than that 
                prescribed by subparagraph (A) because of an 
                emergency which made it medically necessary 
                that the service be provided to the member 
                before it could be provided in a manner 
                prescribed by subparagraph (A).
            (C) Contracts between a health maintenance 
        organization and health professionals for the provision 
        of basic and supplemental health services shall include 
        such provisions as the Secretary may require (including 
        provisions requiring appropriate continuing education).
            (D) Contracts between a health maintenance 
        organization and health professionals for the provision 
        of basic and supplemental health services shall include 
        such provisions as the Secretary may require, but only 
        to the extent that such requirements are designed to 
        insure the delivery of quality health care services and 
        sound fiscal management.
            (4) Basic health services (and only such 
        supplemental health services as members have contracted 
        for) shall within the area served by the health 
        maintenance organization be available and accessible to 
        each of its members with reasonable promptness and in a 
        manner which assures continuity, and when medically 
        necessary be available and accessible twenty-four hours 
        a day and seven days a week, except that a health 
        maintenance organization which has a service area 
        located wholly in a nonmetropolitan area may make a 
        basic health service available outside its service area 
        if that basic health service is not a primary care or 
        emergency health care service and if there is an 
        insufficient number of providers of that basic health 
        service within the service area who will provide such 
        service to members of the health maintenance 
        organization. A member of a health maintenance 
        organization shall be reimbursed by the organization 
        for his expenses in securing basic and supplemental 
        health services other than through the organization if 
        the services were medically necessary and immediately 
        required because of an unforeseen illness, injury, or 
        condition.
            (5) To the extent that a natural disaster, war, 
        riot, civil insurrection, or any other similar event 
        not within the control of a health maintenance 
        organization (as determined under regulations of the 
        Secretary) results in the facilities, personnel, or 
        financial resources of a health maintenance 
        organization not being available to provide or arrange 
        for the provision of a basic or supplemental health 
        service in accordance with the requirements of 
        paragraphs (1) through (4) of this subsection, such 
        requirements only require the organization to make a 
        good-faith effort to provide or arrange for the 
        provision of such service within such limitation on its 
        facilities, personnel, or resources.
            (6) A health maintenance organization that 
        otherwise meets the requirements of this title may 
        offer a high-deductible health plan (as defined in 
        section 220(c)(2) of the Internal Revenue Code of 
        1986).
    (c) Each health maintenance organization shall--
            (1)(A) have--
                    (i) a fiscally sound operation, and
                    (ii) adequate provision against the risk of 
                insolvency,
        which is satisfactory to the Secretary, and (B) have 
        administrative and managerial arrangements satisfactory 
        to the Secretary;
            (2) assume full financial risk on a prospective 
        basis for the provision of basic health services, 
        except that a health maintenance organization may (A) 
        obtain insurance or make other arrangements for the 
        cost of providing to any member basic health services 
        the aggregate value of which exceeds $5,000 in any 
        year, (B) obtain insurance or make other arrangements 
        for the cost of basic health services provided to its 
        members other than through the organization because 
        medical necessity required their provision before they 
        could be secured through the organization, (C) obtain 
        insurance or make other arrangements for not more than 
        90 per centum of the amount by which its costs for any 
        of its fiscal years exceed 115 per centum of its income 
        for such fiscal year, and (D) make arrangements with 
        physicians or other health professionals, health care 
        institutions, or any combination of such individuals or 
        institutions to assume all or part of the financial 
        risk on a prospective basis for the provision of basic 
        health services by the physicians or other health 
        professionals or through the institutions;
            (3)(A) enroll persons who are broadly 
        representative of the various age, social, and income 
        groups within the area it serves, except that in the 
        case of a health maintenance organization which has a 
        medically underserved population located (in whole or 
        in part) in the area it serves, not more than 75 per 
        centum of the members of that organization may be 
        enrolled from the medically underserved population 
        unless the area in which such population resides is 
        also a rural area (as designated by the Secretary), and 
        (B) carry out enrollment of members who are entitled to 
        medical assistance under a State plan approved under 
        title XIX of the Social Security Act in accordance with 
        procedures approved under regulations promulgated by 
        the Secretary;
            (4) not expel or refuse to re-enroll any member 
        because of his health status or his requirements for 
        health services;
            (5) be organized in such a manner that provides 
        meaningful procedures for hearing and resolving 
        grievances between the health maintenance organization 
        (including the medical group or groups and other health 
        delivery entities providing health services for the 
        organization) and the members of the organization;
            (6) have organizational arrangements, established 
        in accordance with regulations of the Secretary, for an 
        ongoing quality assurance program for its health 
        services which program (A) stresses health outcomes, 
        and (B) provides review by physicians and other health 
        professionals of the process followed in the provision 
        of health services;
            (7) adopt at least one of the following 
        arrangements to protect its members from incurring 
        liability for payment of any fees which are the legal 
        obligation of such organization--
                    (A) a contractual arrangement with any 
                hospital that is regularly used by the members 
                of such organization prohibiting such hospital 
                from holding any such member liable for payment 
                of any fees which are the legal obligation of 
                such organization;
                    (B) insolvency insurance, acceptable to the 
                Secretary;
                    (C) adequate financial reserve, acceptable 
                to the Secretary; and
                    (D) other arrangements, acceptable to the 
                Secretary, to protect members,
except that the requirements of this paragraph shall not apply 
to a health maintenance organization if applicable State law 
provides the members of such organization with protection from 
liability for payment of any fees which are the legal 
obligation of such organization; and
    (8) provide, in accordance with regulations of the 
Secretary (including safeguards concerning the confidentiality 
of the doctor-patient relationship), an effective procedure for 
developing, compiling, evaluating, and reporting to the 
Secretary, statistics and other information (which the 
Secretary shall publish and disseminate on an annual basis and 
which the health maintenance organization shall disclose, in a 
manner acceptable to the Secretary, to its members and the 
general public) relating to (A) the cost of its operations, (B) 
the patterns of utilization of its services, (C) the 
availability, accessibility, and acceptability of its services, 
(D) to the extent practical, developments in the health status 
of its members, and (E) such other matters as the Secretary may 
require.
The Secretary shall issue regulations stating the circumstances 
under which the Secretary, in administering paragraph (1)(A), 
will consider the resources of an organization which owns or 
controls a health maintenance organization. Such regulations 
shall require as a condition to consideration of resources that 
an organization which owns or controls a health maintenance 
organization shall provide satisfactory assurances that it will 
assume the financial obligations of the health maintenance 
organization.
    (d) An organization that offers health benefits coverage 
shall not be considered as failing to meet the requirements of 
this section notwithstanding that it provides, with respect to 
coverage offered in connection with a group health plan in the 
small or large group market (as defined in section 2791(e)), an 
affiliation period consistent with the provisions of section 
2701(g).

                              definitions

    Sec. 1302. [300e-1] For purposes of this title:
    (1) The term ``basic health services'' means--
            (A) physician services (including consultant and 
        referral services by a physician);
            (B) inpatient and outpatient hospital services;
            (C) medically necessary emergency health services;
            (D) short-term (not to exceed twenty visits), 
        outpatient evaluative and crisis intervention mental 
        health services;
            (E) medical treatment and referral services 
        (including referral services to appropriate ancillary 
        services) for the abuse of or addiction to alcohol and 
        drugs;
            (F) diagnostic laboratory and diagnostic and 
        therapeutic radiologic services;
            (G) home health services; and
            (H) preventive health services (including (i) 
        immunizations, (ii) well-child care from birth, (iii) 
        periodic health evaluations for adults, (iv) voluntary 
        family planning services, (v) infertility services, and 
        (vi) children's eye and ear examinations conducted to 
        determine the need for vision and hearing correction).
Such term does not include a health service which the 
Secretary, upon application of a health maintenance 
organization, determines is unusual and infrequently provided 
and not necessary for the protection of individual health. The 
Secretary shall publish in the Federal Register each 
determination made by him under the preceding sentence. If a 
service of a physician described in the preceding sentence may 
also be provided under applicable State law by a dentist, 
optometrist, podiatrist, psychologist, or other health care 
personnel a health maintenance organization may provide such 
service through a dentist, optometrist, podiatrist, 
psychologist, or other health care personnel (as the case may 
be) licensed to provide such service. Such term includes a 
health service directly associated with an organ transplant 
only if such organ transplant was required to be included in 
basic health services on April 15, 1985. For purposes of this 
paragraph, the term ``home health services'' means health 
services provided at a member's home by health care personnel, 
as prescribed or directed by the responsible physician or other 
authority designated by the health maintenance organization.
    (2) The term ``supplemental health services'' means any 
health service which is not included as a basic health service 
under paragraph (1) of this section. If a health service 
provided by a physician may also be provided under applicable 
State law by a dentist, optometrist, podiatrist, psychologist, 
or other health care personnel, a health maintenance 
organization may provide such service through an optometrist, 
dentist, podiatrist, psychologist, or other health care 
personnel (as the case may be) licensed to provide such 
service.
    (3) The term ``member'' when used in connection with a 
health maintenance organization means an individual who has 
entered into a contractual agreement, or on whose behalf a 
contractual arrangement has been entered into, with the 
organization under which the organization assumes the 
responsibility for the provision to such individual of basic 
health services and of such supplemental health services as may 
be contracted for.
    (4) The term ``medical group'' means a partnership, 
association, or other group--
            (A) which is composed of health professionals 
        licensed to practice medicine or osteopathy and of such 
        other licensed health professionals (including 
        dentists, optometrists, podiatrists, and psychologists) 
        as are necessary for the provision of health services 
        for which the group is responsible;
            (B) a majority of the members of which are licensed 
        to practice medicine or osteopathy; and
            (C) the members of which (i) as their principal 
        professional activity engage in the coordinated 
        practice of their profession and as a group 
        responsibility have substantial responsibility for the 
        delivery of health services to members of a health 
        maintenance organization, except that this clause does 
        not apply before the end of the forty-eight month 
        period beginning after the month in which the health 
        maintenance oranization \1\ becomes a qualified health 
        maintenance organization as defined in section 1310(d), 
        or as authorized by the Secretary in accordance with 
        regulations that take into consideration the usual 
        circumstances of the group; (ii) pool their income from 
        practice as members of the group and distribute it 
        among themselves according to a prearranged salary or 
        drawing account or other similar plan unrelated to the 
        provision of specific health services; (iii) share 
        medical and other records and substantial portions of 
        major equipment and of professional, technical, and 
        administrative staff; (iv) arrange for and encourage 
        continuing education in the field of clinical medicine 
        and related areas for the members of the group; and (v) 
        establish an arrangement whereby a member's enrollment 
        status is not known to the health professional who 
        provides health services to the member.
---------------------------------------------------------------------------
    \1\ So in law. Probably should be ``organization''.
---------------------------------------------------------------------------
    (5) The term ``individual practice association'' means a 
partnership, corporation, association, or other legal entity 
which has entered into a services arrangement (or arrangements) 
with persons who are licensed to practice medicine, osteopathy, 
dentistry, podiatry, optometry, psychology, or other health 
profession in a State and a majority of whom are licensed to 
practice medicine or osteopathy. Such an arrangement shall 
provide--
            (A) that such persons shall provide their 
        professional services in accordance with a compensation 
        arrangement established by the entity; and
            (B) to the extent feasible, for the sharing by such 
        persons of medical and other records, equipment, and 
        professional, technical, and administrative staff.
    (6) The term ``health systems agency'' means an entity 
which is designated in accordance with section 1515 of this 
Act.
    (7) The term ``medically underserved population'' means the 
population of an urban or rural area designated by the 
Secretary as an area with a shortage of personal health 
services or a population group designated by the Secretary as 
having a shortage of such services. Such a designation may be 
made by the Secretary only after consideration of the comments 
(if any) of (A) each State health planning and development 
agency which covers (in whole or in part) such urban or rural 
area or the area in which such population group resides, and 
(B) each health systems agency designated for a health service 
area which covers (in whole or in part) such urban or rural 
area or the area in which such population group resides.
    (8)(A) The term ``community rating system'' means the 
systems, described in subparagraphs (B) and (C), of fixing 
rates of payments for health services. A health maintenance 
organization may fix its rates of payments under the system 
described in subparagraph (B) or (C) or under both such 
systems, but a health maintenance organization may use only one 
such system for fixing its rates of payments for any one group.
    (B) A system of fixing rates of payment for health services 
may provide that the rates shall be fixed on a per-person or 
per-family basis and may authorize the rates to vary with the 
number of persons in a family, but, except as authorized in 
subparagraph (D), such rates must be equivalent for all 
individuals and for all families of similar composition.
    (C) A system of fixing rates of payment for health services 
may provide that the rates shall be fixed for individuals and 
families by groups. Except as authorized in subparagraph (D), 
such rates must be equivalent for all individuals in the same 
group and for all families of similar composition in the same 
group. If a health maintenance organization is to fix rates of 
payment for individuals and families by groups, it shall--
                    (i)(I) classify all of the members of the 
                organization into classes based on factors 
                which the health maintenance organization 
                determines predict the differences in the use 
                of health services by the individuals or 
                families in each class and which have not been 
                disapproved by the Secretary,
                    (II) determine its revenue requirements for 
                providing services to the members of each class 
                established under subclause (I), and
                    (III) fix the rates of payments for the 
                individuals and families of a group on the 
                basis of a composite of the organization's 
                revenue requirements determined under subclause 
                (II) for providing services to them as members 
                of the classes established under subclause (I), 
                or
                    (ii) fix the rates of payments for the 
                individuals and families of a group on the 
                basis of the organization's revenue 
                requirements for providing services to the 
                group, except that the rates of payments for 
                the individuals and families of a group of less 
                than 100 persons may not be fixed at rates 
                greater than 110 percent of the rate that would 
                be fixed for such individuals and families 
                under subparagraph (B) or clause (i) of this 
                subparagraph.
The Secretary shall review the factors used by each health 
maintenance organization to establish classes under clause (i). 
If the Secretary determines that any such factor may not 
reasonably be used to predict the use of the health services by 
individuals and families, the Secretary shall disapprove such 
factor for such purpose. If a health maintenance organization 
is to fix rates of payment for a group under clause (ii), it 
shall, upon request of the entity with which it contracts to 
provide services to such group, disclose to that entity the 
method and data used in calculating the rates of payment.
    (D) The following differentials in rates of payments may be 
established under the systems described in subparagraphs (B) 
and (C):
            (i) Nominal differentials in such rates may be 
        established to reflect differences in marketing costs 
        and the different administrative costs of collecting 
        payments from the following categories of members:
                    (I) Individual members (including their 
                families).
                    (II) Small groups of members (as determined 
                under regulations of the Secretary).
                    (III) Large groups of members (as 
                determined under regulations of the Secretary).
            (ii) Nominal differentials in such rates may be 
        established to reflect the compositing of the rates of 
        payment in a systematic manner to accommodate group 
        purchasing practices of the various employers.
            (iii) Differentials in such rates may be 
        established for members enrolled in a health 
        maintenance organization pursuant to a contract with a 
        governmental authority under section 1079 or 1086 of 
        title 10, United States Code, or under any other 
        governmental program (other than the health benefits 
        program authorized by chapter 89 of title 5, United 
        States Code) or any health benefits program for 
        employees of States, political subdivision of States, 
        and other public entities.
    (9) The term ``non-metropolitan area'' means an area no 
part of which is within an area designated as a standard 
metropolitan statistical area by the Office of Management and 
Budget and which does not contain a city whose population 
exceeds fifty thousand individuals.

        loans and loan guarantees for initial costs of operation

    Sec. 1305. [300e-4] (a) The Secretary may--
            (1) make loans to public or private health 
        maintenance organizations to assist them in meeting the 
        amount by which their costs of operation during a 
        period not to exceed the first sixty months of their 
        operation exceed their revenues in that period;
            (2) make loans to public or private health 
        maintenance organizations to assist them in meeting the 
        amount by which their costs of operation, which the 
        Secretary determines are attributable to significant 
        expansion in their membership or area served and which 
        are incurred during a period not to exceed the first 
        sixty months of their operation after such expansion, 
        exceed their revenues in that period which the 
        Secretary determines are attributable to such 
        expansion; and
            (3) guarantee to non-Federal lenders payment of the 
        principal of and the interest on loans made to private 
        health maintenance organizations for the amounts 
        referred to in paragraphs (1) and (2).
No loan or loan guarantee may be made under this subsection for 
the costs of operation of a health maintenance organization 
unless the Secretary determines that the organization has made 
all reasonable attempts to meet such costs, and unless the 
Secretary has made a grant or loan to, entered into a contract 
with, or guaranteed a loan for, the organization in fiscal year 
1981, 1982, 1983, 1984, or 1985 under this section or section 
1304(b) (as in effect before October 1, 1985).
    (b)(1) Except as provided in paragraph (2), the aggregate 
amount of principal of loans made or guaranteed, or both, under 
subsection (a) for a health maintenance organization may not 
exceed $7,000,000. In any twelve-month period the amount 
disbursed to a health maintenance organization under this 
section (either directly by the Secretary, by an escrow agent 
under the terms of an escrow agreement, or by a lender under a 
guaranteed loan) may not exceed $3,000,000.
    (2) The cumulative total of the principal of the loans 
outstanding at any time which have been directly made or with 
respect to which guarantees have been issued under subsection 
(a) may not exceed such limitations as may be specified in 
appropriation Acts.
    (c) Loans under this section shall be made from the fund 
established under section 1308(e).
    (d) No loan may be made or guaranteed under this section 
after September 30, 1986.
    (e) Of the sums used for loans under this section in any 
fiscal year from the loan fund established under section 
1308(e), not less than 20 per centum shall be used for loans 
for projects (1) for the initial operation of health 
maintenance organizations which the Secretary determines have 
not less than 66 per centum of their membership drawn from 
residents of nonmetropolitan areas, and (2) the applications 
for which meet the requirements of this title for approval.
    (f) In considering applications for loan guarantees under 
this section, the Secretary shall give special consideration to 
applications for health maintenance organizations which will 
serve medically underserved populations.

                        application requirements

    Sec. 1306. [300e-5] (a) No loan or loan guarantee may be 
made under this title unless an application therefor has been 
submitted to and approved by the Secretary.
    (b) The Secretary may not approve an application for a loan 
or loan guarantee under this title unless--
            (1) such application meets the requirements of 
        section 1308;
            (2) in the case of an application for assistance 
        under section 1305, he determines that the applicant 
        making the application would not be able to complete 
        the project or undertaking for which the application is 
        submitted without the assistance applied for;
            (3) the application contains satisfactory 
        specification of the existing or anticipated (A) 
        population group or groups to be served by the proposed 
        or existing health maintenance organization described 
        in the application, (B) membership of such 
        organization, (C) methods, terms, and periods of the 
        enrollment of members of such organization, (D) 
        estimated costs per member of the health and 
        educational services to be provided by such 
        organization and the nature of such costs, (E) sources 
        of professional services for such organization, and 
        organizational arrangements of such organization for 
        providing health and educational services, (F) 
        organizational arrangements of such organization for an 
        ongoing quality assurance program in conformity with 
        the requirements of section 1301(c), (G) sources of 
        prepayment and other forms of payment for the services 
        to be provided by such organization, (H) facilities, 
        and additional capital investments and sources of 
        financing therefor, available to such organization to 
        provide the level and scope of services proposed, (I) 
        administrative, managerial, and financial arrangements 
        and capabilities of such organization, (J) role for 
        members in the planning and policymaking for such 
        organization, (K) grievance procedures for members of 
        such organization, and (L) evaluations of the support 
        for and acceptance of such organization by the 
        population to be served, the sources of operating 
        support, and the professional groups to be involved or 
        affected thereby;
            (4) contains or is supported by assurances 
        satisfactory to the Secretary that the applicant making 
        the application will, in accordance with such criteria 
        as the Secretary shall by regulation prescribe, enroll, 
        and maintain an enrollment of the maximum number of 
        members that its available and potential resources (as 
        determined under regulations of the Secretary) will 
        enable it to effectively serve;
            (5) in the case of an application made for a 
        project which previously received a grant, contract, 
        loan, or loan guarantee under this title, such 
        application contains or is supported by assurances 
        satisfactory to the Secretary that the applicant making 
        the application has the financial capability to 
        adequately carry out the purposes of such project and 
        has developed and operated such project in accordance 
        with the requirements of this title and with the plans 
        contained in previous applications for such assistance;
            (6) the application contains such assurances as the 
        Secretary may require respecting the intent and the 
        ability of the applicant to meet the requirements of 
        paragraphs (1) and (2) of section 1301(b) respecting 
        the fixing of basic health services payments and 
        supplemental health services payments under a community 
        rating system; and
            (7) the application is submitted in such form and 
        manner, and contains such additional information, as 
        the Secretary shall prescribe in regulations.
An organization making multiple applications for more than one 
loan or loan guarantee under this title, simultaneously or over 
the course of time, shall not be required to submit duplicate 
or redundant information but shall be required to update the 
specifications (required by paragraph (3)) respecting the 
existing or proposed health maintenance organization in such 
manner and with such frequency as the Secretary may by 
regulation prescribe. In determining, for purposes of paragraph 
(2), whether an applicant would be able to complete a project 
or undertaking without the assistance applied for, the 
Secretary shall not consider any asset of the applicant the 
obligation of which for such undertaking or project would 
jeopardize the fiscal soundness of the applicant.
    (c) The Secretary shall by regulation establish standards 
and procedures for health systems agencies to follow in 
reviewing and commenting on applications for loans and loan 
guarantees under this title.

                 administration of assistance programs

    Sec. 1307. [300e-6] (a)(1) Each recipient of a loan or loan 
guarantee under this title shall keep such records as the 
Secretary shall prescribe, including records which fully 
disclose the amount and disposition by such recipient of the 
proceeds of the loan (directly made or guaranteed), the total 
cost of the undertaking in connection with which the loan was 
given or used, the amount of that portion of the cost of the 
undertaking supplied by other sources, and such other records 
as will facilitate an effective audit.
    (2) The Secretary, or any of his duly authorized 
representatives, shall have access for the purpose of audit and 
examination to any books, documents, papers, and records of the 
recipients of a loan or loan guarantee under this title which 
relate to such assistance.
    (b) Upon expiration of the period for which a loan or loan 
guarantee was provided an entity under this title, such entity 
shall make a full and complete report to the Secretary in such 
manner as he may by regulation prescribe. Each such report 
shall contain, among such other matters as the Secretary may by 
regulation require, descriptions of plans, developments, and 
operations relating to the matters referred to in section 
1306(b)(3).
    (d) \1\ An entity which provides health services to a 
defined population on a prepaid basis and which has members who 
are entitled to insurance benefits under title XVIII of the 
Social Security Act or to medical assistance under a State plan 
approved under title XIX of such Act may be considered as a 
health maintenance organization for purposes of receiving 
assistance under this title if--
---------------------------------------------------------------------------
    \1\ Former subsection (c) was repealed by section 803(a) of Public 
Law 99-660.
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            (1) with respect to its members who are entitled to 
        such insurance benefits or to such medical assistance 
        it (A) provides health services in accordance with 
        section 1301(b), except that (i) it does not furnish to 
        those members the health services (within the basic 
        health services) for which it may not be compensated 
        under such title XVIII or such State plan, and (ii) it 
        does not fix the basic or supplemental health services 
        payment for such members under a community rating 
        system, and (B) is organized and operated in the manner 
        prescribed by section 1301(c), except that it does not 
        assume full financial risk on a prospective basis for 
        the provision to such members of basic or supplemental 
        health services with respect to which it is not 
        required under such title XVIII or such State plan to 
        assume such financial risk; and
            (2) with respect to its other members it provides 
        health services in accordance with section 1301(b) and 
        is organized and operated in the manner prescribed by 
        section 1301(c).
An entity which provides health services to a defined 
population on a prepaid basis and which has members who are 
enrolled under the health benefits program authorized by 
chapter 89 of title 5, United States Code, may be considered as 
a health maintenance organization for purposes of receiving 
assistance under this title if with respect to its other 
members it provides health services in accordance with section 
1301(b) and is organized and operated in the manner prescribed 
by section 1301(c).

        general provisions relating to loan guarantees and loans

    Sec. 1308. [300e-7] (a)(1) The Secretary may not approve an 
application for a loan guarantee under this title unless he 
determines that (A) the terms, conditions, security (if any), 
and schedule and amount of repayments with respect to the loan 
are sufficient to protect the financial interests of the United 
States and are otherwise reasonable, including a determination 
that the rate of interest does not exceed such per centum per 
annum on the principal obligation outstanding as the Secretary 
determines to be reasonable, taking into account the range of 
interest rates prevailing in the private market for loans with 
similar maturities, terms, conditions, and security and the 
risks assumed by the United States, and (B) the loan would not 
be available on reasonable terms and conditions without the 
guarantee under this title.
    (2)(A) The United States shall be entitled to recover from 
the applicant for a loan guarantee under this title the amount 
of any payment made pursuant to such guarantee, unless the 
Secretary for good cause waives such right of recovery; and, 
upon making any such payment, the United States shall be 
subrogated to all of the rights of the recipient of the 
payments with respect to which the guarantee was made.
    (B) To the extent permitted by subparagraph (C), any terms 
and conditions applicable to a loan guarantee under this title 
(including terms and conditions imposed under subparagraph (D)) 
may be modified by the Secretary to the extent he determines it 
to be consistent with the financial interest of the United 
States.
    (C) Any loan guarantee made by the Secretary under this 
title shall be incontestable (i) in the hands of an applicant 
on whose behalf such guarantee is made unless the applicant 
engaged in fraud or misrepresentation in securing such 
guarantee, and (ii) as to any person (or his successor in 
interest) who makes or contracts to make a loan to such 
applicant in reliance thereon unless such person (or his 
successor in interest) engaged in fraud or misrepresentation in 
making or contracting to make such loan.
    (D) guarantees of loans under this title shall be subject 
to such further terms and conditions as the Secretary 
determines to be necessary to assure that the purposes of this 
title will be achieved.
    (b)(1) The Secretary may not approve an application for a 
loan under this title unless--
            (A) the Secretary is reasonably satisfied that the 
        applicant therefor will be able to make payments of 
        principal and interest thereon when due, and
            (B) the applicant provides the Secretary with 
        reasonable assurances that there will be available to 
        it such additional funds as may be necessary to 
        complete the project or undertaking with respect to 
        which such loan is requested.
    (2) Any loan made under this title shall (A) have such 
security, (B) have such maturity date, (C) be repayable in such 
installments, (D) on the date the loan is made, bear interest 
at a rate comparable to the rate of interest prevailing on such 
date with respect to marketable obligations of the United 
States of comparable maturities, adjusted to provide for 
appropriate administrative charges, and (E) be subject to such 
other terms and conditions (including provisions for recovery 
in case of default), as the Secretary determines to be 
necessary to carry out the purposes of this title while 
adequately protecting the financial interests of the United 
States. On the date disbursements are made under a loan after 
the initial disbursement under the loan, the Secretary may 
change the rate of interest on the amount of the loan disbursed 
on that date to a rate which is comparable to the rate of 
interest prevailing on the date the subsequent disbursement is 
made with respect to marketable obligations of the United 
States of comparable maturities, adjusted to provide for 
appropriate administrative charges.
    (3) The Secretary may, for good cause but with due regard 
to the financial interests of the United States, waive any 
right of recovery which he has by reason of the failure of a 
borrower to make payments of principal of and interest on a 
loan made under this title, except that if such loan is sold 
and guaranteed, any such waiver shall have no effect upon the 
Secretary's guarantee of timely payment of principal and 
interest.
    (c)(1) The Secretary may from time to time, but with due 
regard to the financial interests of the United States, sell 
loans made by him under this title.
    (2) The Secretary may agree, prior to his sale of any such 
loan, to guarantee to the purchaser (and any successor in 
interest of the purchaser) compliance by the borrower with the 
terms and conditions of such loan. Any such agreement shall 
contain such terms and conditions as the Secretary considers 
necessary to protect the financial interests of the United 
States or as otherwise appropriate. Any such agreement may (A) 
provide that the Secretary shall act as agent of any such 
purchaser for the purpose of collecting from the borrower to 
which such loan was made and paying over to such purchaser, any 
payments of principal and interest payable by such organization 
under such loan; and (B) provide for the repurchase by the 
Secretary of any such loan on such terms and conditions as may 
be specified in the agreement. The full faith and credit of the 
United States is pledged to the payment of all amounts which 
may be required to be paid under any guarantee under this 
paragraph.
    (3) After any loan under this title to a public health 
maintenance organization has been sold and guaranteed under 
this subsection, interest paid on such loan which is received 
by the purchaser thereof (or his successor in interest) shall 
be included in the gross income of the purchaser of the loan 
(or his successor in interest) for the purpose of chapter 1 of 
the Internal Revenue Code of 1954.
    (4) Amounts received by the Secretary as proceeds from the 
sale of loans under this subsection shall be deposited in the 
loan fund established under subsection (e).
    (5) Any reference in this title (other than in this 
subsection and in subsection (d)) to a loan guarantee under 
this title does not include a loan guarantee made under this 
subsection.
    (d)(1) There is established in the Treasury a loan 
guarantee fund (hereinafter in this subsection referred to as 
the ``fund'') which shall be available to the Secretary without 
fiscal year limitation, in such amounts as may be specified 
from time to time in appropriation Acts, to enable him to 
discharge his responsibilities under loan guarantees issued by 
him under this title and to take the action authorized by 
subsection (f). There are authorized to be appropriated from 
time to time such amounts as may be necessary to provide the 
sums required for the fund. To the extent authorized in 
appropriation Acts, there shall also be deposited in the fund 
amounts received by the Secretary in connection with loan 
guarantees under this title and other property or assets 
derived by him from his operations respecting such loan 
guarantees, including any money derived from the sale of 
assets.
    (2) If at any time the sums in the funds are insufficient 
to enable the Secretary to discharge his responsibilities under 
guarantees issued by him before October 1, 1986, under this 
title and to take the action authorized by subsection (f), he 
is authorized to issue to the Secretary of the Treasury notes 
or other obligations in such forms and denominations, bearing 
such maturities, and subject to such terms and conditions, as 
may be prescribed by the Secretary with the approval of the 
Secretary of Treasury. Such notes or other obligations shall 
bear interest at a rate determined by the Secretary of the 
Treasury, taking into consideration the current average market 
yield on outstanding marketable obligations of the United 
States of comparable maturities during the month preceding the 
issuance of the notes or other obligations. The Secretary of 
the Treasury shall purchase any notes and other obligations 
issued under this paragraph and for that purpose he may use as 
a public debt transaction the proceeds from the sale of any 
securities issued under the Second Liberty Bond Act, and the 
purposes for which the securities may be issued under that Act 
are extended to include any purchase of such notes and 
obligations. The Secretary of the Treasury may at any time sell 
any of the notes or other obligations acquired by him under 
this paragraph. All redemptions, purchases, and sales by the 
Secretary of the Treasury of such notes or other obligations 
shall be treated as public debt transactions of the United 
States. Sums borrowed under this paragraph shall be deposited 
in the fund and redemption of such notes and obligations shall 
be made by the Secretary from the fund.
    (e) There is established in the Treasury a loan fund 
(hereinafter in this subsection referred to as the ``fund'') 
which shall be available to the Secretary without fiscal year 
limitation, in such amounts as may be specified from time to 
time in appropriation Acts, to enable him to make loans under 
this title and to take the action authorized by subsection (f). 
There shall also be deposited in the fund amounts received by 
the Secretary as interest payments and repayment of principal 
on loans made under this title and other property or assets 
derived by him from his operations respecting such loans, from 
the sale of loans under subsection (c) of this section, or from 
the sale of assets.
    (f) The Secretary may take such action as he deems 
appropriate to protect the interest of the United States in the 
event of a default on a loan made or guaranteed under this 
title, including taking possession of, holding, and using real 
property pledged as security for such a loan or loan guarantee.

                    authorizations of appropriations

    Sec. 1309. [300e-8] (a) For grants under section 1317 there 
is authorized to be appropriated $1,000,000 for each of the 
fiscal years 1982, 1983, and 1984.
      (b) To meet the obligations of the loan fund established 
under section 1308(e) resulting from defaults on loans made 
from the fund and to meet the other obligations of the fund, 
there is authorized to be appropriated to the loan fund for 
fiscal years 1987, 1988, and 1989, such sums as may be 
necessary.
                    employees' health benefits plans
    Sec. 1310. \1\ [300e-9] (a) In accordance with regulations 
which the Secretary shall prescribe--
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    \1\ Section 1310 as shown above was added by section 7(b) of Public 
Law 100-517. Such section provided in part as follows: ``Effective 7 
years after the date of the enactment of this Act [October 24, 1988], 
section 1310 (42 U.S.C. 300e-9) is amended to read as follows''.

    Section 7(a)(3) of such Public Law provides that nothing in section 
1310 shall be construed to supersede any provision of a collective 
bargaining agreement in effect on [October 24, 1988].

    Section 9 of such Public Law provides as follows: ``With respect to 
abortion services, the Secretary of Health and Human Services shall not 
promulgate or issue any regulations, policy statements, or 
interpretations or develop any practices concerning the performance of 
medically necessary procedures if such regulations, policy statements, 
interpretations, or practices would be inconsistent with those in 
effect on [October 24, 1988].''.
---------------------------------------------------------------------------
            (1) each employer--
                    (A) which is required during any calendar 
                quarter to pay its employees the minimum wage 
                prescribed by section 6 of the Fair Labor 
                Standards Act of 1938 (or would be required to 
                pay its employees such wage but for section 
                13(a) of such Act), and
                    (B) which during such calendar quarter 
                employed an average number of employees of not 
                less than 25, and
            (2) any State and each political subdivision 
        thereof which during any calendar quarter employed an 
        average number of employees of not less than 25, as a 
        condition of payment to the State of funds under 
        section 317, 318, or 1002,
which offers to its employees in the calendar year beginning 
after such calendar quarter the option of membership in a 
qualified health maintenance organization which is engaged in 
the provision of basic health services in a health maintenance 
organization service area in which at least 25 of such 
employees reside shall meet the requirements of subsection (b) 
with respect to any qualified health maintenance organization 
offered by the employer or State or political subdivision.
    (b)(1) If a health benefits plan offered by an employer or 
a State or political subdivision includes contributions for 
services offered under the plan, the employer or State or 
political subdivision shall make a contribution under the plan 
for services offered by a qualified health maintenance 
organization in an amount which does not financially 
discriminate against an employee who enrolls in such 
organization. For purposes of the preceding sentence, an 
employer's or a State's or political subdivision's contribution 
does not financially discriminate if the employer's or State's 
or political subdivision's method of determining the 
contributions on behalf of all employees is reasonable and is 
designed to assure employees a fair choice among health 
benefits plans.
    (2) Each employer or State or political subdivision which 
provides payroll deductions as a means of paying employees' 
contributions for health benefits or which provides a health 
benefits plan to which an employee contribution is not required 
shall, with the consent of an employee who exercises option of 
membership in a qualified health maintenance organization, 
arrange for the employee's contribution for membership in the 
organization to be paid through payroll deductions.
    (3) No employer or State or political subdivision shall be 
required to pay more for health benefits as a result of the 
application of this subsection than would otherwise be required 
by any prevailing collective bargaining agreement or other 
legally enforceable contract for the provision of health 
benefits between the employer or State or political subdivision 
and its employees.
    (c) For purposes of this section, the term ``qualified 
health maintenance organization'' means (1) a health 
maintenance organization which has provided assurances 
satisfactory to the Secretary that it provides basic and 
supplemental health services to its members in the manner 
prescribed by section 1301(b) and that it is organized and 
operated in the manner prescribed by section 1301(c), and (2) 
an entity which proposes to become a health maintenance 
organization and which the Secretary determines will when it 
becomes operational provide basic and supplemental health 
services to its members in the manner prescribed by section 
1301(b) and will be organized and operated in the manner 
prescribed by section 1301(c).
    (d)(1) Any employer who knowingly does not comply with one 
or more of the requirements of paragraph (1) or (2) of 
subsection (b) shall be subject to a civil penalty of not more 
than $10,000. If such noncompliance continues, a civil penalty 
may be assessed and collected under this subsection for each 
thirty-day period such noncompliance continues. Such penalty 
may be assessed by the Secretary and collected in a civil 
action brought by the United States in a United States district 
court.
    (2) In any proceeding by the Secretary to assess a civil 
penalty under this subsection, no penalty shall be assessed 
until the employer charged shall have been given notice and an 
opportunity to present its views on such charge. In determining 
the amount of the penalty, or the amount agreed upon in 
compromise, the Secretary shall consider the gravity of the 
noncompliance and the demonstrated good faith of the employer 
charged in attempting to achieve rapid compliance after 
notification by the Secretary of a noncompliance.
    (3) In any civil action brought to review the assessment of 
a civil penalty assessed under this subsection, the court 
shall, at the request of any party to such action, hold a trial 
de novo on the assessment of such civil penalty and in any 
civil action to collect such a civil penalty, the court shall, 
at the request of any party to such action, hold a trial de 
novo on the assessment of such civil penalty unless in a prior 
civil action to review the assessment of such penalty the court 
held a trial de novo on such assessment.
    (e) For purposes of this section, the term ``employer'' 
does not include (1) the Government of the United States, the 
government of the District of Columbia or any territory or 
possession of the United States, a State or any political 
subdivision thereof, or any agency or instrumentality 
(including the United States Postal Service and Postal Rate 
Commission) of any of the foregoing, except that such term 
includes nonappropriated fund instrumentalities of the 
Government of the United States; or (2) a church, convention or 
association of churches, or any organization operated, 
supervised or controlled by a church, convention or association 
of churches which organization (A) is an organization described 
in section 501(c)(3) of the Internal Revenue Code of 1986, and 
(B) does not discriminate (i) in the employment, compensation, 
promotion, or termination of employment of any personnel, or 
(ii) in the extension of staff or other privileges to any 
physician or other health personnel, because such persons seek 
to obtain or obtained health care, or participate in providing 
health care, through a health maintenance organization.
    (f) If the Secretary, after reasonable notice and 
opportunity for a hearing to a State, finds that it or any of 
its political subdivisions has failed to comply with paragraph 
(1) or (2) of subsection (b), the Secretary shall terminate 
payments to such State under sections 317, 318, and 1002 and 
notify the Governor of such State that further payments under 
such sections will not be made to the State until the Secretary 
is satisfied that there will no longer be any such failure to 
comply.

                  restrictive state laws and practices

    Sec. 1311. [300e-10] (a) In the case of any entity--
            (1) which cannot do business as a health 
        maintenance organization in a State in which it 
        proposes to furnish basic and supplemental health 
        services because that State by law, regulation, or 
        otherwise--
                    (A) requires as a condition to doing 
                business in that State that a medical society 
                approve the furnishing of services by the 
                entity,
                    (B) requires that physicians constitute all 
                or a percentage of its governing body,
                    (C) requires that all physicians or a 
                percentage of physicians in the locale 
                participate or be permitted to participate in 
                the provision of services for the entity,
                    (D) requires that the entity meet 
                requirements for insurers of health care 
                services doing business in that State 
                respecting initial capitalization and 
                establishment of financial reserves against 
                insolvency, or
                    (E) imposes requirements which would 
                prohibit the entity from complying with the 
                requirements of this title, and
            (2) for which a grant, contract, loan, or loan 
        guarantee was made under this title or which is a 
        qualified health maintenance organization for purposes 
        of section 1310 (relating to employees' health benefits 
        plans),
such requirements shall not apply to that entity so as to 
prevent it from operating as a health maintenance organization 
in accordance with section 1301.
    (b) No State may establish or enforce any law which 
prevents a health maintenance organization for which a grant, 
contract, loan, or loan guarantee was made under this title or 
which is a qualified health maintenance organization for 
purposes of section 1310 (relating to employees' health 
benefits plans), from soliciting members through advertising 
its services, charges, or other nonprofessional aspects of its 
operation. This subsection does not authorize any advertising 
which identifies, refers to, or makes any qualitative judgment 
concerning, any health professional who provides services for a 
health maintenance organization.
    (c) The Secretary shall, within 6 months after the date of 
the enactment of this subsection, develop a digest of State 
laws, regulations, and practices pertaining to development, 
establishment, and operation of health maintenance 
organizations which shall be updated at least annually and 
relevant sections of which shall be provided to the Governor of 
each State annually. Such digest shall indicate which State 
laws, regulations, and practices appear to be inconsistent with 
the operation of this section. The Secretary shall also insure 
that appropriate legal consultative assistance is available to 
the States for the purpose of complying with the provisions of 
this section.

        continued regulation of health maintenance organizations

    Sec. 1312. [300e-11] (a) If the Secretary determines that 
an entity which received a grant, contract, loan, or loan 
guarantee under this title as a health maintenance organization 
or which was included in a health benefits plan offered to 
employees pursuant to section 1310--
            (1) fails to provide basic and supplemental 
        services to its members,
            (2) fails to provide such services in the manner 
        prescribed by section 1301(b), or
            (3) is not organized or operated in the manner 
        prescribed by section 1301(c),
the Secretary may take the action authorized by subsection (b).
    (b)(1) If the Secretary makes, with respect to any entity 
which provided assurances to the Secretary under section 
1310(d)(1), a determination described in subsection (a), the 
Secretary shall notify the entity in writing of the 
determination. Such notice shall specify the manner in which 
the entity has not complied with such assurances and direct 
that the entity initiate (within 30 days of the date the notice 
is issued by the Secretary or within such longer period as the 
Secretary determines is reasonable) such action as may be 
necessary to bring (within such period as the Secretary shall 
prescribe) the entity into compliance with the assurances. If 
the entity fails to initiate corrective action within the 
period prescribed by the notice or fails to comply with the 
assurances within such period as the Secretary prescribes, then 
after the Secretary provides the entity a reasonable 
opportunity for reconsideration of his determination, 
including, at the entity's election, a fair hearing (A) the 
entity shall not be a qualified health maintenance organization 
for purposes of section 1310 until such date as the Secretary 
determines that it is in compliance with the assurances, and 
(B) each employer which has offered membership in the entity in 
compliance with section 1310, each lawfully recognized 
collective bargaining representative or other employee 
representative which represents the employees of each such 
employer, and the members of such entity shall be notified by 
the entity that the entity is not a qualified health 
maintenance organization for purposes of such section. The 
notice required by clause (B) of the preceding sentence shall 
contain, in readily understandable language, the reasons for 
the determination that the entity is not a qualified health 
maintenance organization. The Secretary shall publish in the 
Federal Register each determination referred to in this 
paragraph.
    (2) If the Secretary makes, with respect to an entity which 
has received a grant, contract, loan, or loan guarantee under 
this title, a determination described in subsection (a), the 
Secretary may, in addition to any other remedies available to 
him, bring a civil action in the United States district court 
for the district in which such entity is located to enforce its 
compliance with the assurances it furnished respecting the 
provision of basic and supplemental health services or its 
organization or operation, as the case may be, which assurances 
were made in connection with its application under this title 
for the grant, contract, loan, or loan guarantee.

  limitation on source of funding for health maintenance organizations

    Sec. 1313. [300e-12] No funds appropriated under any 
provision of this Act (except as provided in sections 329 and 
330) other than this title may be used--
            (1) for grants or contracts for surveys or other 
        activities to determine the feasibility of developing 
        or expanding health maintenance organizations or other 
        entities which provide, directly or indirectly, health 
        services to a defined population on a prepaid basis;
            (2) for grants or contracts, or for payments under 
        loan guarantees, for planning projects for the 
        establishment or expansion of such organizations or 
        entities;
            (3) for grants or contracts, or for payments under 
        loan guarantees, for projects for the initial 
        development or expansion of such organizations or 
        entities; or
            (4) for loans, or for payments under loan 
        guarantees, to assist in meeting the costs of the 
        initial operation after establishment or expansion of 
        such organizations or entities or in meeting the costs 
        of such organizations in acquiring or constructing 
        ambulatory health care facilities.

                             annual report

    Sec. 1315. [300e-14] (a) The Secretary shall periodically 
review the programs of assistance authorized by this title and 
make an annual report to the Congress of a summary of the 
activities under each program. The Secretary shall include in 
such summary--
            (1) a summary of each grant, contract, loan, or 
        loan guarantee made under this title in the period 
        covered by the report and a list of the health 
        maintenance organizations which during such period 
        became qualified health maintenance organizations for 
        purposes of section 1310;
            (2) the statistics and other information reported 
        in such period to the Secretary in accordance with 
        section 1301(c)(11);
            (3) findings with respect to the ability of the 
        health maintenance organizations assisted under this 
        title--
                    (A) to operate on a fiscally sound basis 
                without continued Federal financial assistance,
                    (B) to meet the requirements of section 
                1301(c) respecting their organization and 
                operation,
                    (C) to provide basic and supplemental 
                health services in the manner prescribed by 
                section 1301(b),
                    (D) to include indigent and high-risk 
                individuals in their membership, and
                    (E) to provide services to medically 
                underserved populations; and
            (4) findings with respect to--
                    (A) the operation of distinct categories of 
                health maintenance organizations in comparison 
                with each other,
                    (B) health maintenance organizations as a 
                group in comparison with alternative forms of 
                health care delivery, and
                    (C) the impact that health maintenance 
                organizations, individually, by category, and 
                as a group, have on the health of the public.
    (b) The Office of Management and Budget may review the 
Secretary's report under subsection (a) before its submission 
to the Congress, but the Office may not revise the report or 
delay its submission, and it may submit to the Congress its 
comments (and those of other departments or agencies of the 
Government) respecting such report.

                   training and technical assistance

    Sec. 1317. [300e-16] (a)(1) The Secretary shall establish a 
National Health Maintenance Organization Intern Program 
(hereinafter in this subsection referred to as the ``Program'') 
for the purpose of providing training to individuals to become 
administrators and medical directors of health maintenance 
organizations or to assume other managerial positions with 
health maintenance organizations. Under the Program the 
Secretary may directly provide internships for such training 
and may make grants to or enter into contracts with health 
maintenance organizations and other entities to provide such 
internships.
    (2) No internship may be provided by the Secretary and no 
grant may be made or contract entered into by the Secretary for 
the provision of internships unless an application therefor has 
been submitted to and approved by the Secretary. Such an 
application shall be in such form and contain such information, 
and be submitted to the Secretary in such manner, as the 
Secretary shall prescribe. Section 1306 does not apply to an 
application submitted under this section.
    (3) Internships under the Program shall provide for such 
stipends and allowances (including travel and subsistence 
expenses and dependency allowances) for the recipients of the 
internships as the Secretary deems necessary. An internship 
provided an individual for training at a health maintenance 
organization or any other entity shall also provide for 
payments to be made to the organization or other entity for the 
cost of support services (including the cost of salaries, 
supplies, equipment, and related items) provided such 
individual by such organization or other entity. The amount of 
any such payments to any organization or other entity shall be 
determined by the Secretary and shall bear a direct 
relationship to the reasonable costs of the organization or 
other entity for establishing and maintaining its training 
programs.
    (4) Payments under grants under the Program may be made in 
advance or by way of reimbursement, and at such intervals and 
on such conditions, as the Secretary finds necessary.
    (b) The Secretary shall provide technical assistance (1) to 
entities intending to become a qualified health maintenance 
organization within the meaning of section 1310(d), and (2) to 
health maintenance organizations. The Secretary may provide 
such technical assistance through grants to public and 
nonprofit private entities and contracts with public and 
private entities.
    (c) The authority of the Secretary to enter into contracts 
under subsections (a) and (b) shall be effective for any fiscal 
year only to such extent or in such amounts as are provided in 
advance by appropriation Acts.

                          financial disclosure

    Sec. 1318. [300e-17] (a) Each health maintenance 
organization shall, in accordance with regulations of the 
Secretary, report to the Secretary financial information which 
shall include the following:
            (1) Such information as the Secretary may require 
        demonstrating that the health maintenance organization 
        has a fiscally sound operation.
            (2) A copy of the report, if any, filed with the 
        Centers for Medicare & Medicaid Services containing the 
        information required to be reported under section 1124 
        of the Social Security Act by disclosing entities and 
        the information required to be supplied under section 
        1902(a)(38) of such Act.
            (3) A description of transactions, as specified by 
        the Secretary, between the health maintenance 
        organization and a party in interest. Such transactions 
        shall include--
                    (A) any sale or exchange, or leasing of any 
                property between the health maintenance 
                organization and a party in interest;
                    (B) any furnishing for consideration of 
                goods, services (including management 
                services), or facilities between the health 
                maintenance organization and a party in 
                interest, but not including salaries paid to 
                employees for services provided in the normal 
                course of their employment and health services 
                provided to members by hospitals and other 
                providers and by staff, medical group (or 
                groups), individual practice association (or 
                associations), or any combination thereof; and
                    (C) any lending of money or other extension 
                of credit between a health maintenance 
                organization and a party in interest.
The Secretary may require that information reported respecting 
a health maintenance organization which controls, is controlled 
by, or is under common control with, another entity be in the 
form of a consolidated financial statement for the organization 
and such entity.
    (b) For the purposes of this section the term ``party in 
interest'' means:
            (1) any director, officer, partner, or employee 
        responsible for management or administration of a 
        health maintenance organization, any person who is 
        directly or indirectly the beneficial owner of more 
        than 5 per centum of the equity of the organization, 
        any person who is the beneficial owner of a mortgage, 
        deed of trust, note, or other interest secured by, and 
        valuing more than 5 per centum of the health 
        maintenance organization, and, in the case of a health 
        maintenance organization organized as a nonprofit 
        corporation, an incorporator or member of such 
        corporation under applicable State corporation law;
            (2) any entity in which a person described in 
        paragraph (1)--
                    (A) is an officer or director;
                    (B) is a partner (if such entity is 
                organized as a partnership);
                    (C) has directly or indirectly a beneficial 
                interest of more than 5 per centum of the 
                equity; or
                    (D) has a mortgage, deed of trust, note, or 
                other interest valuing more than 5 per centum 
                of the assets of such entity;
            (3) any person directly or indirectly controlling, 
        controlled by, or under common control with a health 
        maintenance organization; and
            (4) any spouse, child, or parent of an individual 
        described in paragraph (1).
    (c) Each health maintenance organization shall make the 
information reported pursuant to subsection (a) available to 
its enrollees upon reasonable request.
    (d) The Secretary shall, as he deems necessary, conduct an 
evaluation of transactions reported to the Secretary under 
subsection (a)(3) for the purpose of determining their adverse 
impact, if any, on the fiscal soundness and reasonableness of 
charges to the health maintenance organization with respect to 
which they transpired. The Secretary shall evaluate the 
reported transactions of not less than five, or if there are 
more than twenty health maintenance organizations reporting 
such transactions, not less than one-fourth of the health 
maintenance organizations reporting any such transactions under 
subsection (a)(3).
    (f) \1\ Nothing in this section shall be construed to 
confer upon the Secretary any authority to approve or 
disapprove the rates charged by any health maintenance 
organization.
---------------------------------------------------------------------------
    \1\ Subsection (e) was repealed by section 810 of Public Law 99-
660.
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    (g) Any health maintenance organization failing to file 
with the Secretary the annual financial statement required in 
subsection (a) shall be ineligible for any Federal assistance 
under this title until such time as such statement is received 
by the Secretary and shall not be a qualified health 
maintenance organization for purposes of section 1310.
    (h) Whoever knowingly and willfully makes or causes to be 
made any false statement or representation of a material fact 
in any statement filed pursuant to this section shall be guilty 
of a felony and upon conviction thereof shall be fined not more 
than $25,000 or imprisoned for not more than five years, or 
both.
               TITLE XIV--SAFETY OF PUBLIC WATER SYSTEMS

     [For Text of This Title See Volume 2 of the Environmental Law 
                              Compilation]
    TITLE XV--PREVENTIVE HEALTH MEASURES WITH RESPECT TO BREAST AND 
                            CERVICAL CANCERS

SEC. 1501. [300K] ESTABLISHMENT OF PROGRAM OF GRANTS TO STATES.

    (a) In General.--The Secretary, acting through the Director 
of the Centers for Disease Control and Prevention, may make 
grants to States on the basis of an established competitive 
review process for the purpose of carrying out programs--
            (1) to screen women for breast and cervical cancer 
        as a preventive health measure;
            (2) to provide appropriate referrals for medical 
        treatment of women screened pursuant to paragraph (1) 
        and to ensure, to the extent practicable, the provision 
        of appropriate follow-up services and support services 
        such as case management;
            (3) to develop and disseminate public information 
        and education programs for the detection and control of 
        breast and cervical cancer;
            (4) to improve the education, training, and skills 
        of health professionals (including allied health 
        professionals) in the detection and control of breast 
        and cervical cancer;
            (5) to establish mechanisms through which the 
        States can monitor the quality of screening procedures 
        for breast and cervical cancer, including the 
        interpretation of such procedures; and
            (6) to evaluate activities conducted under 
        paragraphs (1) through (5) through appropriate 
        surveillance or program-monitoring activities.
    (b) Grant and Contract Authority of States.--
            (1) In general.--A State receiving a grant under 
        subsection (a) may, subject to paragraphs (2) and (3), 
        expend the grant to carry out the purpose described in 
        such subsection through grants to public and nonprofit 
        private entities and through contracts with public and 
        private entities.
            (2) Certain applications.--If a nonprofit private 
        entity and a private entity that is not a nonprofit 
        entity both submit applications to a State to receive 
        an award of a grant or contract pursuant to paragraph 
        (1), the State may give priority to the application 
        submitted by the nonprofit private entity in any case 
        in which the State determines that the quality of such 
        application is equivalent to the quality of the 
        application submitted by the other private entity.
            (3) Payments for screenings.--The amount paid by a 
        State to an entity under this subsection for a 
        screening procedure under subsection (a)(1) may not 
        exceed the amount that would be paid under part B of 
        title XVIII of the Social Security Act if payment were 
        made under such part for furnishing the procedure to a 
        woman enrolled under such part.
    (c) Special Consideration for Certain States.--In making 
grants under subsection (a) to States whose initial grants 
under such subsection are made for fiscal year 1995 or any 
subsequent fiscal year, the Secretary shall give special 
consideration to any State whose proposal for carrying out 
programs under such subsection--
            (1) has been approved through a process of peer 
        review; and
            (2) is made with respect to geographic areas in 
        which there is--
                    (A) a substantial rate of mortality from 
                breast or cervical cancer; or
                    (B) a substantial incidence of either of 
                such cancers.
    (d) Coordinating Committee Regarding Year 2020 Health 
Objectives.--The Secretary, acting through the Director of the 
Centers for Disease Control and Prevention, shall establish a 
committee to coordinate the activities of the agencies of the 
Public Health Service (and other appropriate Federal agencies) 
that are carried out toward achieving the objectives 
established by the Secretary for reductions in the rate of 
mortality from breast and cervical cancer in the United States 
by the year 2020. Such committee shall be comprised of Federal 
officers or employees designated by the heads of the agencies 
involved to serve on the committee as representatives of the 
agencies, and such representatives from other public or private 
entities as the Secretary determines to be appropriate.

SEC. 1502. [300L] REQUIREMENT OF MATCHING FUNDS.

    (a) In General.--The Secretary may not make a grant under 
section 1501 unless the State involved agrees, with respect to 
the costs to be incurred by the State in carrying out the 
purpose described in such section, to make available non-
Federal contributions (in cash or in kind under subsection (b)) 
toward such costs in an amount equal to not less than $1 for 
each $3 of Federal funds provided in the grant. Such 
contributions may be made directly or through donations from 
public or private entities.
    (b) Determination of Amount of Non-Federal Contribution.--
            (1) In general.--Non-Federal contributions required 
        in subsection (a) may be in cash or in kind, fairly 
        evaluated, including equipment or services (and 
        excluding indirect or overhead costs). Amounts provided 
        by the Federal Government, or services assisted or 
        subsidized to any significant extent by the Federal 
        Government, may not be included in determining the 
        amount of such non-Federal contributions.
            (2) Maintenance of effort.--In making a 
        determination of the amount of non-Federal 
        contributions for purposes of subsection (a), the 
        Secretary may include only non-Federal contributions in 
        excess of the average amount of non-Federal 
        contributions made by the State involved toward the 
        purpose described in section 1501 for the 2-year period 
        preceding the first fiscal year for which the State is 
        applying to receive a grant under such section.
            (3) Inclusion of relevant non-federal contributions 
        for medicaid.--In making a determination of the amount 
        of non-Federal contributions for purposes of subsection 
        (a), the Secretary shall, subject to paragraphs (1) and 
        (2) of this subsection, include any non-Federal amounts 
        expended pursuant to title XIX of the Social Security 
        Act by the State involved toward the purpose described 
        in paragraphs (1) and (2) of section 1501(a).

SEC. 1502A. [300L-1] REQUIREMENT REGARDING MEDICAID.

    The Secretary may not make a grant under section 1501 for a 
program in a State unless the State plan under title XIX of the 
Social Security Act for the State includes the screening 
procedures specified in subparagraphs (A) and (B) of section 
1503(a)(2) as medical assistance provided under the plan.

SEC. 1503. [300M] REQUIREMENTS WITH RESPECT TO TYPE AND QUALITY OF 
                    SERVICES.

    (a) Requirement of Provision of All Services by Date 
Certain.--The Secretary may not make a grant under section 1501 
unless the State involved agrees--
            (1) to ensure that, initially and throughout the 
        period during which amounts are received pursuant to 
        the grant, not less than 60 percent of the grant is 
        expended to provide each of the services or activities 
        described in paragraphs (1) and (2) of section 1501(a), 
        including making available screening procedures for 
        both breast and cervical cancers;
            (2) subject to subsection (b), to ensure that--
                    (A) in the case of breast cancer, both a 
                physical examination of the breasts and the 
                screening procedure known as a mammography are 
                conducted; and
                    (B) in the case of cervical cancer, both a 
                pelvic examination and the screening procedure 
                known as a pap smear are conducted;
            (3) to ensure that, by the end of any second fiscal 
        year of payments pursuant to the grant, each of the 
        services or activities described in section 1501(a) is 
        provided; and
            (4) to ensure that not more than 40 percent of the 
        grant is expended to provide the services or activities 
        described in paragraphs (3) through (6) of such 
        section.
    (b) Use of Improved Screening Procedures.--The Secretary 
may not make a grant under section 1501 unless the State 
involved agrees that, if any screening procedure superior to a 
procedure described in subsection (a)(2) becomes commonly 
available and is recommended for use, any entity providing 
screening procedures pursuant to the grant will utilize the 
superior procedure rather than the procedure described in such 
subsection.
    (c) \1\ Quality Assurance Regarding Screening Procedures.--
The Secretary may not make a grant under section 1501 unless 
the State involved agrees that the State will, in accordance 
with applicable law, assure the quality of screening procedures 
conducted pursuant to such section.
---------------------------------------------------------------------------
    \1\ Section 101(c)(2) of Public Law 103-183 (107 Stat. 2228) 
provides as follows:
---------------------------------------------------------------------------

          ``(2) Transition rule regarding mammographies.--With respect 
        to the screening procedure for breast cancer known as a 
        mammography, the requirements in effect on the day before the 
        date of the enactment of this Act under section 1503(c) of the 
        Public Health Service Act remain in effect (for an individual 
        or facility conducting such procedures pursuant to a grant to a 
        State under section 1501 of such Act) until there is in effect 
        for the facility a certificate (or provisional certificate) 
        issued under section 354 of such Act.''.
    (d) Waiver of Services Requirement on Division of Funds.--
            (1) In general.--The Secretary shall establish a 
        demonstration project under which the Secretary may 
        waive the requirements of paragraphs (1) and (4) of 
        subsection (a) for not more than 5 States, if--
                    (A) the State involved will use the waiver 
                to leverage non-Federal funds to supplement 
                each of the services or activities described in 
                paragraphs (1) and (2) of section 1501(a);
                    (B) the application of such requirement 
                would result in a barrier to the enrollment of 
                qualifying women;
                    (C) the State involved--
                            (i) demonstrates, to the 
                        satisfaction of the Secretary, the 
                        manner in which the State will use such 
                        waiver to expand the level of screening 
                        and follow-up services provided 
                        immediately prior to the date on which 
                        the waiver is granted; and
                            (ii) provides assurances, 
                        satisfactory to the Secretary, that the 
                        State will, on an annual basis, 
                        demonstrate, through such documentation 
                        as the Secretary may require, that the 
                        State has used such waiver as described 
                        in clause (i);
                    (D) the State involved submits to the 
                Secretary--
                            (i) assurances, satisfactory to the 
                        Secretary, that the State will maintain 
                        the average annual level of State 
                        fiscal year expenditures for the 
                        services and activities described in 
                        paragraphs (1) and (2) of section 
                        1501(a) for the period for which the 
                        waiver is granted, and for the period 
                        for which any extension of such wavier 
                        is granted, at a level that is not less 
                        than--
                                    (I) the level of the State 
                                fiscal year expenditures for 
                                such services and activities 
                                for the fiscal year preceding 
                                the first fiscal year for which 
                                the waiver is granted; or
                                    (II) at the option of the 
                                State and upon approval by the 
                                Secretary, the average level of 
                                the State expenditures for such 
                                services and activities for the 
                                3-fiscal year period preceding 
                                the first fiscal year for which 
                                the waiver is granted; and
                            (ii) a plan, satisfactory to the 
                        Secretary, for maintaining the level of 
                        activities carried out under the waiver 
                        after the expiration of the waiver and 
                        any extension of such waiver;
                    (E) the Secretary finds that granting such 
                a waiver to a State will increase the number of 
                women in the State that receive each of the 
                services or activities described in paragraphs 
                (1) and (2) of section 1501(a), including 
                making available screening procedures for both 
                breast and cervical cancers; and
                    (F) the Secretary finds that granting such 
                a waiver to a State will not adversely affect 
                the quality of each of the services or 
                activities described in paragraphs (1) and (2) 
                of section 1501(a).
            (2) Duration of waiver.--
                    (A) In general.--In granting waivers under 
                paragraph (1), the Secretary--
                            (i) shall grant such waivers for a 
                        period that is not less than 1 year but 
                        not more than 2 years; and
                            (ii) upon request of a State, may 
                        extend a waiver for an additional 
                        period that is not less than 1 year but 
                        not more than 2 years in accordance 
                        with subparagraph (B).
                    (B) Additional period.--The Secretary, upon 
                the request of a State that has received a 
                waiver under paragraph (1), shall, at the end 
                of the waiver period described in subparagraph 
                (A)(i), review performance under the waiver and 
                may extend the waiver for an additional period 
                if the Secretary determines that--
                            (i) without an extension of the 
                        waiver, there will be a barrier to the 
                        enrollment of qualifying women;
                            (ii) the State requesting such 
                        extended waiver will use the waiver to 
                        leverage non-Federal funds to 
                        supplement the services or activities 
                        described in paragraphs (1) and (2) of 
                        section 1501(a);
                            (iii) the waiver has increased, and 
                        will continue to increase, the number 
                        of women in the State that receive the 
                        services or activities described in 
                        paragraphs (1) and (2) of section 
                        1501(a);
                            (iv) the waiver has not, and will 
                        not, result in lower quality in the 
                        State of the services or activities 
                        described in paragraphs (1) and (2) of 
                        section 1501(a); and
                            (v) the State has maintained the 
                        average annual level of State fiscal 
                        expenditures for the services and 
                        activities described in paragraphs (1) 
                        and (2) of section 1501(a) for the 
                        period for which the waiver was granted 
                        at a level that is not less than--
                                    (I) the level of the State 
                                fiscal year expenditures for 
                                such services and activities 
                                for the fiscal year preceding 
                                the first fiscal year for which 
                                the waiver is granted; or
                                    (II) at the option of the 
                                State and upon approval by the 
                                Secretary, the average level of 
                                the State expenditures for such 
                                services and activities for the 
                                3-fiscal year period preceding 
                                the first fiscal year for which 
                                the waiver is granted.
            (3) Reporting requirements.--The Secretary shall 
        include as part of the evaluations and reports required 
        under section 1508, the following:
                    (A) A description of the total amount of 
                dollars leveraged annually from Non-Federal 
                entities in States receiving a waiver under 
                paragraph (1) and how these amounts were used.
                    (B) With respect to States receiving a 
                waiver under paragraph (1), a description of 
                the percentage of the grant that is expended on 
                providing each of the services or activities 
                described in--
                            (i) paragraphs (1) and (2) of 
                        section 1501(a); and
                            (ii) paragraphs (3) through (6) of 
                        section 1501(a).
                    (C) A description of the number of States 
                receiving waivers under paragraph (1) annually.
                    (D) With respect to States receiving a 
                waiver under paragraph (1), a description of--
                            (i) the number of women receiving 
                        services under paragraphs (1), (2), and 
                        (3) of section 1501(a) in programs 
                        before and after the granting of such 
                        waiver; and
                            (ii) the average annual level of 
                        State fiscal expenditures for the 
                        services and activities described in 
                        paragraphs (1) and (2) of section 
                        1501(a) for the year preceding the 
                        first year for which the waiver was 
                        granted.
            (4) Limitation.--Amounts to which a waiver applies 
        under this subsection shall not be used to increase the 
        number of salaried employees.
            (5) Definitions.--In this subsection:
                    (A) Indian tribe.--The term ``Indian 
                tribe'' has the meaning given the term in 
                section 4 of the Indian Health Care Improvement 
                Act (25 U.S.C. 1603).
                    (B) Tribal organization.--The term ``tribal 
                organization'' has the meaning given the term 
                in section 4 of the Indian Health Care 
                Improvement Act.
                    (C) State.--The term ``State'' means each 
                of the several States of the United States, the 
                District of Columbia, the Commonwealth of 
                Puerto Rico, American Samoa, the Commonwealth 
                of the Northern Mariana Islands, the Republic 
                of the Marshall Islands, the Federated States 
                of Micronesia, the Republic of Palau, an Indian 
                tribe, and a tribal organization.
            (6) Sunset.--The Secretary may not grant a waiver 
        or extension under this subsection after September 30, 
        2012.

SEC. 1504. [300N] ADDITIONAL REQUIRED AGREEMENTS.

    (a) Priority for Low-Income Women.--The Secretary may not 
make a grant under section 1501 unless the State involved 
agrees that low-income women will be given priority in the 
provision of services and activities pursuant to paragraphs (1) 
and (2) of section 1501(a).
    (b) Limitation on Imposition of Fees for Services.--The 
Secretary may not make a grant under section 1501 unless the 
State involved agrees that, if a charge is imposed for the 
provision of services or activities under the grant, such 
charge--
            (1) will be made according to a schedule of charges 
        that is made available to the public;
            (2) will be adjusted to reflect the income of the 
        woman involved; and
            (3) will not be imposed on any woman with an income 
        of less than 100 percent of the official poverty line, 
        as established by the Director of the Office of 
        Management and Budget and revised by the Secretary in 
        accordance with section 673(2) of the Omnibus Budget 
        Reconciliation Act of 1981.
    (c) Statewide Provision of Services.--
            (1) In general.--The Secretary may not make a grant 
        under section 1501 unless the State involved agrees 
        that services and activities under the grant will be 
        made available throughout the State, including 
        availability to members of any Indian tribe or tribal 
        organization (as such terms are defined in section 4 of 
        the Indian Self-Determination and Education Assistance 
        Act).
            (2) Waiver.--The Secretary may waive the 
        requirement established in paragraph (1) for a State if 
        the Secretary determines that compliance by the State 
        with the requirement would result in an inefficient 
        allocation of resources with respect to carrying out 
        the purpose described in section 1501(a).
            (3) Grants to tribes and tribal organizations.--
                    (A) The Secretary, acting through the 
                Director of the Centers for Disease Control and 
                Prevention, may make grants to tribes and 
                tribal organizations (as such terms are used in 
                paragraph (1)) for the purpose of carrying out 
                programs described in section 1501(a). This 
                title applies to such a grant (in relation to 
                the jurisdiction of the tribe or organization) 
                to the same extent and in the same manner as 
                such title applies to a grant to a State under 
                section 1501 (in relation to the jurisdiction 
                of the State).
                    (B) If a tribe or tribal organization is 
                receiving a grant under subparagraph (A) and 
                the State in which the tribe or organization is 
                located is receiving a grant under section 
                1501, the requirement established in paragraph 
                (1) for the State regarding the tribe or 
                organization is deemed to have been waived 
                under paragraph (2).
    (d) Relationship to Items and Services Under Other 
Programs.--The Secretary may not make a grant under section 
1501 unless the State involved agrees that the grant will not 
be expended to make payment for any item or service to the 
extent that payment has been made, or can reasonably be 
expected to be made, with respect to such item or service--
            (1) under any State compensation program, under an 
        insurance policy, or under any Federal or State health 
        benefits program; or
            (2) by an entity that provides health services on a 
        prepaid basis.
    (e) Coordination With Other Breast and Cervical Cancer 
Programs.--The Secretary may not make a grant under section 
1501 unless the State involved agrees that the services and 
activities funded through the grant shall be coordinated with 
other Federal, State, and local breast and cervical cancer 
programs.
    (f) Limitation on Administrative Expenses.--The Secretary 
may not make a grant under section 1501 unless the State 
involved agrees that not more than 10 percent of the grant will 
be expended for administrative expenses with respect to the 
grant.
    (g) Restrictions on Use of Grant.--The Secretary may not 
make a grant under section 1501 unless the State involved 
agrees that the grant will not be expended to provide inpatient 
hospital services for any individual.
    (h) Records and Audits.--The Secretary may not make a grant 
under section 1501 unless the State involved agrees that--
            (1) the State will establish such fiscal control 
        and fund accounting procedures as may be necessary to 
        ensure the proper disbursal of, and accounting for, 
        amounts received by the State under such section; and
            (2) upon request, the State will provide records 
        maintained pursuant to paragraph (1) to the Secretary 
        or the Comptroller of the United States for purposes of 
        auditing the expenditures by the State of the grant.
    (i) Reports to Secretary.--The Secretary may not make a 
grant under section 1501 unless the State involved agrees to 
submit to the Secretary such reports as the Secretary may 
require with respect to the grant.

SEC. 1505. [300N-1] DESCRIPTION OF INTENDED USES OF GRANT.

    The Secretary may not make a grant under section 1501 
unless--
            (1) the State involved submits to the Secretary a 
        description of the purposes for which the State intends 
        to expend the grant;
            (2) the description identifies the populations, 
        areas, and localities in the State with a need for the 
        services or activities described in section 1501(a);
            (3) the description provides information relating 
        to the services and activities to be provided, 
        including a description of the manner in which the 
        services and activities will be coordinated with any 
        similar services or activities of public and private 
        entities; and
            (4) the description provides assurances that the 
        grant funds will be used in the most cost-effective 
        manner.

SEC. 1506. [300N-2] REQUIREMENT OF SUBMISSION OF APPLICATION.

    The Secretary may not make a grant under section 1501 
unless an application for the grant is submitted to the 
Secretary, the application contains the description of intended 
uses required in section 1505, and the application is in such 
form, is made in such manner, and contains such agreements, 
assurances, and information as the Secretary determines to be 
necessary to carry out this title.

SEC. 1507. [300N-3] TECHNICAL ASSISTANCE AND PROVISION OF SUPPLIES AND 
                    SERVICES IN LIEU OF GRANT FUNDS.

    (a) Technical Assistance.--The Secretary may provide 
training and technical assistance with respect to the planning, 
development, and operation of any program or service carried 
out pursuant to section 1501. The Secretary may provide such 
technical assistance directly or through grants to, or 
contracts with, public and private entities.
    (b) Provision of Supplies and Services in Lieu of Grant 
Funds.--
            (1) In general.--Upon the request of a State 
        receiving a grant under section 1501, the Secretary 
        may, subject to paragraph (2), provide supplies, 
        equipment, and services for the purpose of aiding the 
        State in carrying out such section and, for such 
        purpose, may detail to the State any officer or 
        employee of the Department of Health and Human 
        Services.
            (2) Corresponding reduction in payments.--With 
        respect to a request described in paragraph (1), the 
        Secretary shall reduce the amount of payments under the 
        grant under section 1501 to the State involved by an 
        amount equal to the costs of detailing personnel 
        (including pay, allowances, and travel expenses) and 
        the fair market value of any supplies, equipment, or 
        services provided by the Secretary. The Secretary 
        shall, for the payment of expenses incurred in 
        complying with such request, expend the amounts 
        withheld.

SEC. 1508. [300N-4] EVALUATIONS AND REPORTS.

    (a) Evaluations.--The Secretary shall, directly or through 
contracts with public or private entities, provide for annual 
evaluations of programs carried out pursuant to section 1501. 
Such evaluations shall include evaluations of--
            (1) the extent to which States carrying out such 
        programs are in compliance with section 1501(a)(2) and 
        with section 1504(c); and
            (2) the extent to which each State receiving a 
        grant under this title is in compliance with section 
        1502, including identification of--
                    (A) the amount of the non-Federal 
                contributions by the State for the preceding 
                fiscal year, disaggregated according to the 
                source of the contributions; and
                    (B) the proportion of such amount of non-
                Federal contributions relative to the amount of 
                Federal funds provided through the grant to the 
                State for the preceding fiscal year.
    (b) Report to Congress.--The Secretary shall, not later 
than 1 year after the date of the enactment of the National 
Breast and Cervical Cancer Early Detection Program 
Reauthorization of 2007, and annually thereafter, submit to the 
Committee on Energy and Commerce of the House of 
Representatives, and to the Committee on Labor and Human 
Resources of the Senate, a report summarizing evaluations 
carried out pursuant to subsection (a) during the preceding 
fiscal year and making such recommendations for administrative 
and legislative initiatives with respect to this title as the 
Secretary determines to be appropriate, including 
recommendations regarding compliance by the States with section 
1501(a)(2) and with section 1504(c).

SEC. 1509. [300N-4A] SUPPLEMENTAL GRANTS FOR ADDITIONAL PREVENTIVE 
                    HEALTH SERVICES.

    (a) Demonstration Projects.--In the case of States 
receiving grants under section 1501, the Secretary, acting 
through the Director of the Centers for Disease Control and 
Prevention, may make grants to not more than 3 such States to 
carry out demonstration projects for the purpose of--
            (1) providing preventive health services in 
        addition to the services authorized in such section, 
        including screenings regarding blood pressure and 
        cholesterol, and including health education;
            (2) providing appropriate referrals for medical 
        treatment of women receiving services pursuant to 
        paragraph (1) and ensuring, to the extent practicable, 
        the provision of appropriate follow-up services; and
            (3) evaluating activities conducted under 
        paragraphs (1) and (2) through appropriate surveillance 
        or program-monitoring activities.
    (b) Status as Participant in Program Regarding Breast and 
Cervical Cancer.--The Secretary may not make a grant under 
subsection (a) unless the State involved agrees that services 
under the grant will be provided only through entities that are 
screening women for breast or cervical cancer pursuant to a 
grant under section 1501.
    (c) Applicability of Provisions of General Program.--This 
title applies to a grant under subsection (a) to the same 
extent and in the same manner as such title applies to a grant 
under section 1501.
    (d) Funding.--
            (1) In general.--Subject to paragraph (2), for the 
        purpose of carrying out this section, there are 
        authorized to be appropriated $3,000,000 for fiscal 
        year 1994, and such sums as may be necessary for each 
        of the fiscal years 1995 through 2003.
            (2) Limitation regarding funding with respect to 
        breast and cervical cancer.--The authorization of 
        appropriations established in paragraph (1) is not 
        effective for a fiscal year unless the amount 
        appropriated under section 1510(a) for the fiscal year 
        is equal to or greater than $100,000,000.

SEC. 1510. [300N-5] FUNDING FOR GENERAL PROGRAM.

    (a) Authorization of Appropriations.--For the purpose of 
carrying out this title, there are authorized to be 
appropriated $50,000,000 for fiscal year 1991, such sums as may 
be necessary for each of the fiscal years 1992 and 1993, 
$150,000,000 for fiscal year 1994, such sums as may be 
necessary for each of the fiscal years 1995 through 2003, 
$225,000,000 for fiscal year 2008, $245,000,000 for fiscal year 
2009, $250,000,000 for fiscal year 2010, $255,000,000 for 
fiscal year 2011, and $275,000,000 for fiscal year 2012.
    (b) Set-Aside for Technical Assistance and Provision of 
Supplies and Services.--Of the amounts appropriated under 
subsection (a) for a fiscal year, the Secretary shall reserve 
not more than 20 percent for carrying out section 1507.
                TITLE XVI--HEALTH RESOURCES DEVELOPMENT

                   Part A--Loans and Loan Guarantees

                authority for loans and loan guarantees

    Sec. 1601. [300q] (a)(1) The Secretary, during the period 
ending September 30, 1982, may, in accordance with this part, 
make loans from the fund established under section 1602(d) to 
any public or nonprofit private entity for projects for--
            (A) the discontinuance of unneeded hospital 
        services or facilities;
            (B) the conversion of unneeded hospital services 
        and facilities to needed health services and medical 
        facilities, including outpatient medical facilities and 
        facilities for long-term care;
            (C) the renovation and modernization of medical 
        facilities, particularly projects for the prevention or 
        elimination of safety hazards, projects to avoid 
        noncompliance with licensure or accreditation 
        standards, or projects to replace obsolete facilities;
            (D) the construction of new outpatient medical 
        facilities; and
            (E) the construction of new inpatient medical 
        facilities in areas which have experienced (as 
        determined by the Secretary) recent rapid population 
        growth.
    (2)(A) The Secretary, during the period ending September 
30, 1982, may, in accordance with this part, guarantee to--
            (i) non-Federal lenders for their loans to public 
        and nonprofit private entities for medical facilities 
        projects described in paragraph (1), and
            (ii) the Federal Financing Bank for its loans to 
        public and nonprofit private entities for such 
        projects,
payment of principal and interest on such loans.
    (B) In the case of a guarantee of any loan to a public or 
nonprofit private entity under subparagraph (A)(i) which is 
located in an urban or rural poverty area, the Secretary may 
pay, to the holder of such loan and for and on behalf of the 
project for which the loan was made, amounts sufficient to 
reduce by not more than one-half the net effective interest 
rate otherwise payable on such loan if the Secretary finds that 
without such assistance the project could not be undertaken.
    (b) The principal amount of a loan directly made or 
guaranteed under subsection (a) for a medical facilities 
project, when added to any other assistance provided such 
project under part B, may not exceed 90 per centum of the cost 
of such project unless the project is located in an area 
determined by the Secretary to be an urban or rural poverty 
area, in which case the principal amount, when added to other 
assistance under part B, may cover up to 100 per centum of such 
costs.
    (c) The cumulative total of the principal of the loans 
outstanding at any time with respect to which guarantees have 
been issued, or which have been directly made, may not exceed 
such limitations as may be specified in appropriation Acts.
    (d) The Secretary, with the consent of the Secretary of 
Housing and Urban Development, shall obtain from the Department 
of Housing and Urban Development such assistance with respect 
to the administration of this part as will promote efficiency 
and economy thereof.

        general provisions relating to loan guarantees and loans

    Sec. 1602. [300q-2] (a)(1) The Secretary may not approve a 
loan guarantee for a project under this part unless he 
determines that (A) the terms, conditions, security (if any), 
and schedule and amount of repayments with respect to the loan 
are sufficient to protect the financial interests of the United 
States and are otherwise reasonable, including a determination 
that the rate of interest does not exceed such per centum per 
annum on the principal obligation outstanding as the Secretary 
determines to be reasonable, taking into account the range of 
interest rates prevailing in the private market for similar 
loans and the risks assumed by the United States, and (B) the 
loan would not be available on reasonable terms and conditions 
without the guarantee under this part.
    (2)(A) The United States shall be entitled to recover from 
the applicant for a loan guarantee under this part the amount 
of any payment made pursuant to such guarantee, unless the 
Secretary for good cause waives such right of recovery; and, 
upon making any such payment, the United States shall be 
subrogated to all of the rights of the recipient of the 
payments with respect to which the guarantee was made.
    (B) To the extent permitted by subparagraph (C), any terms 
and conditions applicable to a loan guarantee under this part 
(including terms and conditions imposed under subparagraph (D)) 
may be modified by the Secretary to the extent he determines it 
to be consistent with the financial interest of the United 
States.
    (C) Any loan guarantee made by the Secretary under this 
part shall be incontestable (i) in the hands of an applicant on 
whose behalf such guarantee is made unless the applicant 
engaged in fraud or misrepresentation in securing such 
guarantee, and (ii) as to any person (or his successor in 
interest) who makes or contracts to make a loan to such 
applicant in reliance thereon unless such person (or his 
successor in interest) engaged in fraud or misrepresentation in 
making or contracting to make such loan.
    (D) Guarantees of loans under this part shall be subject to 
such further terms and conditions as the Secretary determines 
to be necessary to assure that the purposes of this title will 
be achieved.
    (b)(1) The Secretary may not approve a loan under this part 
unless--
            (A) the Secretary is reasonably satisfied that the 
        applicant under the project for which the loan would be 
        made will be able to make payments of principal and 
        interest thereon when due, and
            (B) the applicant provides the Secretary with 
        reasonable assurances that there will be available to 
        it such additional funds as may be necessary to 
        complete the project or undertaking with respect to 
        which such loan is requested.
    (2) Any loan made under this part shall (A) have such 
security, (B) have such maturity date, (C) be repayable in such 
installments, (D) bear interest at a rate comparable to the 
current rate of interest prevailing, on the date the loan is 
made, with respect to loans guaranteed under this part, minus 
any interest subsidy made in accordance with section 
1601(a)(2)(B) with respect to a loan made for a project located 
in an urban or rural poverty area, and (E) be subject to such 
other terms and conditions (including provisions for recovery 
in case of default), as the Secretary determines to be 
necessary to carry out the purposes of this title while 
adequately protecting the financial interests of the United 
States.
    (3) The Secretary may, for good cause but with due regard 
to the financial interests of the United States, waive any 
right of recovery which he has by reasons of the failure of a 
borrower to make payments of principal of and interest on a 
loan made under this part, except that if such loan is sold and 
guaranteed, any such waiver shall have no effect upon the 
Secretary's guarantee of timely payment of principal and 
interest.
    (c)(1) The Secretary shall from time to time, but with due 
regard to the financial interests of the United States, sell 
loans made under this part either on the private market or to 
the Federal National Mortgage Association in accordance with 
section 302 of the Federal National Mortgage Association 
Charter Act or to the Federal Financing Bank.
    (2) Any loan so sold shall be sold for an amount which is 
equal (or approximately equal) to the amount of the unpaid 
principal of such loans as of time of sale.
    (3)(A) The Secretary is authorized to enter into an 
agreement with the purchaser of any loan sold under this part 
under which the Secretary agrees--
            (i) to guarantee to such purchaser (and any 
        successor in interest to such purchaser) payments of 
        the principal and interest payable under such loan, and
            (ii) to pay as an interest subsidy to such 
        purchaser (and any successor in interest of such 
        purchaser) amounts which, when added to the amount of 
        interest payable on such loan, are equivalent to a 
        reasonable rate of interest on such loan as determined 
        by the Secretary after taking into account the range of 
        prevailing interest rates in the private market on 
        similar loans and the risks assumed by the United 
        States.
    (B) Any agreement under subparagraph (A)--
            (i) may provide that the Secretary shall act as 
        agent of any such purchaser, for the purpose of 
        collecting from the entity to which such loan was made 
        and paying over to such purchaser any payments of 
        principal and interest payable by such entity under 
        such loan;
            (ii) may provide for the repurchase by the 
        Secretary of any such loan on such terms and conditions 
        as may be specified in the agreement;
            (iii) shall provide that, in the event of any 
        default by the entity to which such loan was made in 
        payment of principal or interest due on such loan, the 
        Secretary shall, upon notification to the purchaser (or 
        to the successor in interest of such purchaser), have 
        the option to close out such loan (and any obligations 
        of the Secretary with respect thereto) by paying to the 
        purchaser (or his successor in interest) the total 
        amount of outstanding principal and interest due 
        thereon at the time of such notification; and
            (iv) shall provide that, in the event such loan is 
        closed out as provided in clause (iii), or in the event 
        of any other loss incurred by the Secretary by reason 
        of the failure of such entity to make payments of 
        principal or interest on such loan, the Secretary shall 
        be subrogated to all rights of such purchaser for 
        recovery of such loss from such entity.
    (4) Amounts received by the Secretary as proceeds from the 
sale of loans under this subsection shall be deposited in the 
fund established under subsection (d).
    (5) If any loan to a public entity under this part is sold 
and guaranteed by the Secretary under this subsection, interest 
paid on such loan after its sale and any interest subsidy paid, 
under paragraph (3)(A)(ii), by the Secretary with respect to 
such loan which is received by the purchaser of the loan (or 
the purchaser's successor in interest) shall be included in the 
gross income of the purchaser or successor for the purpose of 
chapter 1 of the Internal Revenue Code of 1954.
    (d)(1) There is established in the Treasury a loan and loan 
guarantee fund (hereinafter in this subsection referred to as 
the ``fund'') which shall be available to the Secretary without 
fiscal year limitation, in such amounts as may be specified 
from time to time in appropriation Acts--
            (A) to enable him to make loans under this part,
            (B) to enable him to discharge his responsibilities 
        under loan guarantees issued by him under this part,
            (C) for payment of interest under section 
        1601(a)(2)(B) on loans guaranteed under this part,
            (D) for repurchase of loans under subsection 
        (c)(3)(B),
            (E) for payment of interest on loans which are sold 
        and guaranteed, and
            (F) to enable the Secretary to take the action 
        authorized by subsection (f).
There are authorized to be appropriated from time to time such 
amounts as may be necessary to provide the sums required for 
the fund. There shall also be deposited in the fund amounts 
received by the Secretary in connection with loans and loan 
guarantees under this part and other property or assets derived 
by him from his operations respecting such loans and loan 
guarantees, including any money derived from the sale of 
assets.
    (2) If at any time the sums in the funds are insufficient 
to enable the Secretary--
            (A) to make payments of interest under section 
        1601(a)(2)(B),
            (B) to otherwise comply with guarantees under this 
        part of loans to nonprofit private entities,
            (C) in the case of a loan which was made, sold, and 
        guaranteed under this part, to make to the purchaser of 
        such loan payments of principal and interest on such 
        loan after default by the entity to which the loan was 
        made, or
            (D) to repurchase loans under subsection (c)(3)(B),
            (E) to make payments of interest on loans which are 
        sold and guaranteed, and
            (F) to enable the Secretary to take the action 
        authorized by subsection (f),
he is authorized to issue to the Secretary of the Treasury 
notes or other obligations in such forms and denominations 
bearing such maturities, and subject to such terms and 
conditions, as may be prescribed by the Secretary with the 
approval of the Secretary of the Treasury. Such notes or other 
obligations shall bear interest at a rate determined by the 
Secretary of the Treasury, taking into consideration the 
current average market yield on outstanding marketable 
obligations of the United States of comparable maturities 
during the month preceding the issuance of the notes or other 
obligations. The Secretary of the Treasury shall purchase any 
notes and other obligations issued under this paragraph and for 
that purpose he may use as a public debt transaction the 
proceeds from the sale of any securities issued under the 
Second Liberty Bond Act, and the purposes for which the 
securities may be issued under that Act are extended to include 
any purchase of such notes and obligations. The Secretary of 
the Treasury may at any time sell any of the notes or other 
obligations acquired by him under this paragraph. All 
redemptions, purchases, and sales by the Secretary of the 
Treasury of such notes or other obligations shall be treated as 
public debt transactions of the United States. Sums borrowed 
under this paragraph shall be deposited in the fund and 
redemption of such notes and obligations shall be made by the 
Secretary from the fund.
    (e)(1) The assets, commitments, obligations, and 
outstanding balances of the loan guarantee and loan fund 
established in the Treasury by section 626 shall be transferred 
to the fund established by subsection (d) of this section.
    (2) To provide additional capitalization for the fund 
established under subsection (d) there are authorized to be 
appropriated to the fund, such sums as may be necessary for the 
fiscal years ending June 30, 1975, June 30, 1976, September 30, 
1977, September 30, 1978, September 30, 1979, September 30, 
1980, September 30, 1981, and September 30, 1982.
    (f)(1) The Secretary may take such action as may be 
necessary to prevent a default on a loan made or guaranteed 
under this part or under title VI, including the waiver of 
regulatory conditions, deferral of loan payments, renegotiation 
of loans, and the expenditure of funds for technical and 
consultative assistance, for the temporary payment of the 
interest and principal on such a loan, and for other purposes. 
Any such expenditure made under the preceding sentence on 
behalf of a medical facility shall be made under such terms and 
conditions as the Secretary shall prescribe, including the 
implementation of such organizational, operational, and 
financial reforms as the Secretary determines are appropriate 
and the disclosure of such financial or other information as 
the Secretary may require to determine the extent of the 
implementation of such reforms.
    (2) The Secretary may take such action, consistent with 
State law respecting foreclosure procedures, as he deems 
appropriate to protect the interest of the United States in the 
event of a default on a loan made or guaranteed under this part 
or under title VI, including selling real property pledged as 
security for such a loan or loan guarantee and for a reasonable 
period of time taking possession of, holding, and using real 
property pledged as security for such a loan or loan guarantee.

                         Part B--Project Grants

                             project grants

    Sec. 1610. [300r] (a)(1)(A) The Secretary may make grants 
for construction or modernization projects designed to--
            (i) eliminate or prevent in medical facilities 
        imminent safety hazards as defined by Federal, State, 
        or local fire, building, or life safety codes or 
        regulations, or
            (ii) avoid noncompliance by medical facilities with 
        State or voluntary licensure or accreditation 
        standards.
    (B) A grant under subparagraph (A) may only be made to--
            (i) a State or political subdivision of a State, 
        including any city, town, county, borough, hospital 
        district authority, or public or quasi-public 
        corporation, for any medical facility owned or operated 
        by the State or political subdivision; and
            (ii) a nonprofit private entity for any medical 
        facility owned or operated by the entity but only if 
        the Secretary determines--
                    (I) the level of community service provided 
                by the facility and the proportion of its 
                patients who are unable to pay for services 
                rendered in the facility is similar to such 
                level and proportion in a medical facility of a 
                State or political subdivision, and
                    (II) that without a grant under 
                subparagraph (A) there would be a disruption of 
                the provision of health care to low-income 
                individuals.
    (2) The amount of any grant under paragraph (1) may not 
exceed 75 per centum of the cost of the project for which the 
grant is made unless the project is located in an area 
determined by the Secretary to be an urban or rural poverty 
area, in which case the grant may cover up to 100 per centum of 
such costs.
    (3) There are authorized to be appropriated for grants 
under paragraph (1) $40,000,000 for the fiscal year ending 
September 30, 1980, $50,000,000 for the fiscal year ending 
September 30, 1981, and $50,000,000 for the fiscal year ending 
September 30, 1982. Funds available for obligation under this 
subsection (as in effect before the date of the enactment of 
the Health Planning and Resources Development Amendments of 
1979) in the fiscal year ending September 30, 1979, shall 
remain available for obligation under this subsection in the 
succeeding fiscal year.
    (b)(1) The Secretary may make grants to public and 
nonprofit private entities for projects for (A) construction or 
modernization of outpatient medical facilities which are 
located apart from hospitals and which will provide services 
for medically underserved populations, and (B) conversion of 
existing facilities into outpatient medical facilities or 
facilities for long-term care to provide services for such 
populations.
    (2) The amount of any grant under paragraph (1) may not 
exceed 80 per centum of the cost of the project for which the 
grant is made unless the project is located in an area 
determined by the Secretary to be an urban or rural poverty 
area, in which case the grant may cover up to 100 per centum of 
such costs.
    (3) There are authorized to be appropriated for grants 
under paragraph (1) $15,000,000 for the fiscal year ending 
September 30, 1981, and $15,000,000 for the fiscal year ending 
September 30, 1982.

                       Part C--General Provisions

                          general regulations

    Sec. 1620. [300s] The Secretary shall by regulation--
            (1) prescribe the manner in which he shall 
        determine the priority among projects for which 
        assistance is available under part A or B, based on the 
        relative need of different areas for such projects and 
        giving special consideration--
                    (A) to projects for medical facilities 
                serving areas with relatively small financial 
                resources and for medical facilities serving 
                rural communities,
                    (B) in the case of projects for 
                modernization of medical facilities, to 
                projects for facilities serving densely 
                populated areas,
                    (C) in the case of projects for 
                construction of outpatient medical facilities, 
                to projects that will be located in, and 
                provide services for residents of, areas 
                determined by the Secretary to be rural or 
                urban poverty areas,
                    (D) to projects designed to (i) eliminate 
                or prevent imminent safety hazards as defined 
                by Federal, State, or local fire, building, or 
                life safety codes or regulations, or (ii) avoid 
                noncompliance with State or voluntary licensure 
                or accreditation standards, and
                    (E) to projects for medical facilities 
                which, alone or in conjunction with other 
                facilities, will provide comprehensive health 
                care, including outpatient and preventive care 
                as well as hospitalization;
            (2) prescribe for medical facilities projects 
        assisted under part A or B general standards of 
        construction, modernization, and equipment, which 
        standards may vary on the basis of the class of 
        facilities and their location; and
            (3) prescribe the general manner in which easy 
        entity which receives financial assistance under part A 
        or B or has received financial assistance under part A 
        or B or title VI shall be required to comply with the 
        assurances required to be made at the time such 
        assistance was received and the means by which such 
        entity shall be required to demonstrate compliance with 
        such assurances.
An entity subject to the requirements prescribed pursuant to 
paragraph (3) respecting compliance with assurances made in 
connection with receipt of financial assistance shall submit 
periodically to the Secretary data and information which 
reasonably supports the entity's compliance with such 
assurances. The Secretary may not waive the requirement of the 
preceding sentence.

                              applications

    Sec. 1621. [300s-1] (a) No loan, loan guarantee, or grant 
may be made under part A or B for a medical facilities project 
unless an application for such project has been submitted to 
and approved by the Secretary. If two or more entities join in 
a project, an application for such project may be filed by any 
of such entities or by all of them.
    (b)(1) An application for a medical facilities project 
shall be submitted in such form and manner as the Secretary 
shall by regulation prescribe and shall, except as provided in 
paragraph (2), set forth--
            (A) in the case of a modernization project for a 
        medical facility for continuation of existing health 
        services, a finding by the State Agency of a continued 
        need for such services, and, in the case of any other 
        project for a medical facility, a finding by the State 
        Agency of the need for the new health services to be 
        provided through the medical facility upon completion 
        of the project;
            (B) in the case of an application for a grant, 
        assurances satisfactory to the Secretary that (i) the 
        applicant making the application would not be able to 
        complete the project for which the application is 
        submitted without the grant applied for, and (ii) in 
        the case of a project to construct a new medical 
        facility, it would be inappropriate to convert an 
        existing medical facility to provide the services to be 
        provided through the new medical facility;
            (C) in the case of a project for the discontinuance 
        of a service or facility or the conversion of a service 
        or a facility, an evaluation of the impact of such 
        discontinuance or conversion on the provision of health 
        care in the health service area in which such service 
        was provided or facility located;
            (D) a description of the site of such project;
            (E) plans and specifications therefor which meet 
        the requirements of the regulations prescribed under 
        section 1620(2);
            (F) reasonable assurance that title to such site is 
        or will be vested in one or more of the entities filing 
        the application or in a public or other nonprofit 
        entity which is to operate the facility on completion 
        of the project;
            (G) reasonable assurance that adequate financial 
        support will be available for the completion of the 
        project and for its maintenance and operation when 
        completed, and, for the purpose of determining if the 
        requirements of this subparagraph are met, Federal 
        assistance provided directly to a medical facility 
        which is located in an area determined by the Secretary 
        to be an urban or rural poverty area or through 
        benefits provided individuals served at such facility 
        shall be considered as financial support;
            (H) the type of assistance being sought under part 
        A or B for the project;
            (I) reasonable assurance that all laborers and 
        mechanics employed by contractors or subcontractors in 
        the performance of work on a project will be paid wages 
        at rates not less than those prevailing on similar 
        construction in the locality as determined by the 
        Secretary of Labor in accordance with the Act of March 
        3, 1931 (40 U.S.C. 276a--276a-5, known as the Davis-
        Bacon Act), and the Secretary of Labor shall have with 
        respect to such labor standards the authority and 
        functions set forth in Reorganization Plan Numbered 14 
        of 1950 (15 FR 3176; 5 U.S.C. Appendix) and section 2 
        of the Act of June 13, 1934 (40 U.S.C. 276c);
            (J) in the case of a project for the construction 
        or modernization of an outpatient facility, reasonable 
        assurance that the services of a general hospital will 
        be available to patients at such facility who are in 
        need of hospital care; and
            (K) reasonable assurance that at all times after 
        such application is approved (i) the facility or 
        portion thereof to be constructed, modernized, or 
        converted will be made available to all persons 
        residing or employed in the area served by the 
        facility, and (ii) there will be made available in the 
        facility or portion thereof to be constructed, 
        modernized, or converted a reasonable volume of 
        services to persons unable to pay therefor and the 
        Secretary, in determining the reasonableness of the 
        volume of services provided, shall take into 
        consideration the extent to which compliance is 
        feasible from a financial viewpoint.
    (2)(A) The Secretary may waive--
            (i) the requirements of subparagraph (D) of 
        paragraph (1) for compliance with modernization and 
        equipment standards prescribed pursuant to section 
        1620(2), and
            (ii) the requirement of subparagraph (E) of 
        paragraph (1) respecting title to a project site,
in the case of an application for a project described in 
subparagraph (B) of this paragraph.
    (B) A project referred to in subparagraph (A) is a 
project--
            (i) for the modernization of an outpatient medical 
        facility which will provide general purpose health 
        services, which is not part of a hospital, and which 
        will serve a medically underserved population as 
        defined in section 1624 or as designated by a health 
        systems agency, and
            (ii) for which the applicant seeks a loan under 
        part A the principal amount of which does not exceed 
        $20,000.* deg.

                                recovery

    Sec. 1622. [300s-1a] (a) If any facility with respect to 
which funds have been paid under this title shall, at any time 
within 20 years after the completion of construction or 
modernization--* deg.
            (1) be sold or transferred to any entity (A) which 
        is not qualified to file an application under section 
        1621 or 1642 or (B) which is not approved as a 
        transferee by the State Agency of the State in which 
        such facility is located, or its successor, or
            (2) cease to be a public health center or a public 
        or other nonprofit hospital, outpatient facility, 
        facility for long-term care, or rehabilitation 
        facility,
the United States shall be entitled to recover, whether from 
the transferor or the transferee (or, in the case of a facility 
which has ceased to be public or nonprofit, from the owners 
thereof) an amount determined under subsection (c).
    (b) The transferor of a facility which is sold or 
transferred as described in subsection (a)(1), or the owner of 
a facility the use of which is changed as described in 
subsection (a)(2), shall provide the Secretary written notice 
of such sale, transfer, or change not later than the expiration 
of 10 days from the date on which such sale, transfer, or 
change occurs.
    (c)(1) Except as provided in paragraph (2), the amount the 
United States shall be entitled to recover under subsection (a) 
is an amount bearing the same ratio to the then value (as 
determined by the agreement of the parties or in an action 
brought in the district court of the United States for the 
district for which the facility involved is situated) of so 
much of the facility as constituted an approved project or 
projects as the amount of the Federal participation bore to the 
cost of the construction or modernization of such project or 
projects.
    (2)(A) After the expiration of--
            (i) 180 days after the date of the sale, transfer, 
        or change of use for which a notice is required by 
        subsection (b) in the case of a facility which is sold 
        or transferred or the use of which changes after the 
        date of the enactment of this subsection, or
            (ii) thirty days after the date of enactment of 
        this subsection or if later 180 days after the date of 
        the sale, transfer, or change of use for which a notice 
        is required by subsection (b), in the case of a 
        facility which was sold or transferred or the use of 
        which changed before the date of the enactment of this 
        subsection,
the amount which the United States is entitled to recover under 
paragraph (1) with respect to a facility shall be the amount 
prescribed by paragraph (1) plus interest, during the period 
described in subparagraph (B), at a rate (determined by the 
Secretary) based on the average of the bond equivalent of the 
weekly 90-day Treasury bill auction rate.
    (B) The period referred to in subparagraph (A) is the 
period beginning--
            (i) in the case of a facility which was sold or 
        transferred or the use of which changed before the date 
        of the enactment of this subsection, thirty days after 
        such date or if later 180 days after the date of the 
        sale, transfer, or change of use for which a notice is 
        required by subsection (b),
            (ii) in the case of a facility with respect to 
        which notice is provided in accordance with subsection 
        (b), upon the expiration of 180 days after the receipt 
        of such notice, or
            (iii) in the case of a facility with respect to 
        which such notice is not provided as prescribed by 
        subsection (b), on the date of the sale, transfer, or 
        changes of use for which such notice was to be 
        provided,
and ending on the date the amount the United States is entitled 
to under paragraph (1) is collected.
    (d)(1) The Secretary may waive the recovery rights of the 
United States under subsection (a)(1) with respect to a 
facility in any State if the Secretary determines, in 
accordance with regulations, that the entity to which the 
facility was sold or transferred--
            (A) has established an irrevocable trust--
                    (i) in an amount equal to the greater of 
                twice the cost of the remaining obligation of 
                the facility under clause (ii) of section 
                1621(b)(1)(K) or the amount, determined under 
                subsection (c), that the United States is 
                entitled to recover, and
                    (ii) which will only be used by the entity 
                to provide the care required by clause (ii) of 
                section 1621(b)(1)(K); and
            (B) will meet the obligation of the facility under 
        clause (i) of section 1621(b)(1)(K).
    (2) The Secretary may waive the recovery rights of the 
United States under subsection (a)(2) with respect to a 
facility in any State if the Secretary determines, in 
accordance with regulations, that there is good cause for 
waiving such rights with respect to such facility.
    (e) The right of recovery of the United States under 
subsection (a) shall not constitute a lien on any facility with 
respect to which funds have been paid under this title.

                         control of operations

    Sec. 1623. [300s-2] Except as otherwise specifically 
provided, nothing in this title shall be construed as 
conferring on any Federal officer, or employee the right to 
exercise any supervision or control over the administration, 
personnel, maintenance, or operation of any facility with 
respect to which any funds have been or may be expended under 
this title.

                              definitions

    Sec. 1624. [300s-3] Except as provided in section 1642(e), 
for purposes of this title--
            (1) The term ``hospital'' includes general, 
        tuberculosis, and other types of hospitals, and related 
        facilities, such as laboratories, outpatient 
        departments, nurses' home facilities, extended care 
        facilities, facilities related to programs for home 
        health services, self-care units, and central service 
        facilities, operated in connection with hospitals, and 
        also includes education or training facilities for 
        health professonal \1\ personnel operated as an 
        integral part of a hospital, but does not include any 
        hospital furnishing primarily domiciliary care.
---------------------------------------------------------------------------
    \1\ So in law. Probably should be ``professional''.
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            (2) The term ``public health center'' means a 
        publicly owned facility for the provision of public 
        health services, including related publicly owned 
        facilities such as laboratories, clinics, and 
        administrative offices operated in connection with such 
        a facility.
            (3) The term ``nonprofit'' as applied to any 
        facility means a facility which is owned and operated 
        by one or more nonprofit corporations or associations 
        no part of the net earnings of which inures, or may 
        lawfully inure, to the benefit of any private 
        shareholder or individual.
            (4) The term ``outpatient medical facility'' means 
        a medical facility (located in or apart from a 
        hospital) for the diagnosis or diagnosis and treatment 
        of ambulatory patients (including ambulatory 
        inpatients)--
                    (A) which is operated in connection with a 
                hospital;
                    (B) in which patient care is under the 
                professional supervision of persons licensed to 
                practice medicine or surgery in the State, or 
                in the case of dental diagnosis or treatment, 
                under the professional supervision of persons 
                licensed to practice dentistry in the State; or
                    (C) which offers to patients not requiring 
                hospitalization the services of licensed 
                physicians in various medical specialties and 
                which provides to its patients a reasonably 
                full range of diagnostic and treatment 
                services.
            (5) The term ``rehabilitation facility'' means a 
        facility which is operated for the primary purpose of 
        assisting in the rehabilitation of disabled persons 
        through an integrated program of--
                    (A) medical evaluation and services, and
                    (B) psychological, social, or vocational 
                evaluation and services,
        under competent professional supervision, and in the 
        case of which the major portion of the required 
        evaluation and services is furnished within the 
        facility; and either the facility is operated in 
        connection with a hospital, or all medical and related 
        health services are prescribed by, or are under the 
        general direction of, persons licensed to practice 
        medicine or surgery in the State.
            (6) The term ``facility for long-term care'' means 
        a facility (including a skilled nursing or intermediate 
        care facility) providing in-patient care for 
        convalescent or chronic disease patients who required 
        skilled nursing or intermediate care and related 
        medical services--
                    (A) which is a hospital (other than a 
                hospital primarily for the care and treatment 
                of mentally ill or tuberculosis patients) or is 
                operated in connection with a hospital, or
                    (B) in which such care and medical services 
                are prescribed by, or are performed under the 
                general direction of, persons licensed to 
                practice medicine or surgery in the State.
            (7) The term ``construction'' means construction of 
        new buildings and initial equipment of such buildings 
        and, in any case in which it will help to provide a 
        service not previously provided in the community, 
        equipment of any buildings; including architects' fees, 
        but excluding the cost of off-site improvements and, 
        except with respect to public health centers, the cost 
        of the acquisition of land
            (8) The term ``cost'' as applied to construction 
        modernization, or conversion means the amount found by 
        the Secretary to be necessary for construction, 
        modernization, or conversion, respectively, under a 
        project, except that, in the case of a modernization 
        project or a project assisted under part D, such term 
        does not include any amount found by the Secretary to 
        be attributable to expansion of the bed capacity of any 
        facility.
            (9) The term ``modernization'' includes the 
        alteration, expansion, major repair (to the extent 
        permitted by regulations), remodeling, replacement, and 
        renovation of existing buildings (including initial 
        equipment thereof), and the replacement of obsolete 
        equipment of existing buildings.
            (10) The term ``title,'' \1\ when used with 
        reference to a site for a project, means a fee simple, 
        or such other estate or interest (including a leasehold 
        on which the rental does not exceed 4 per centum of the 
        value of the land) as the Secretary finds sufficient to 
        assure for a period of not less than twenty-five years' 
        undisturbed use and possession for the purposes of 
        construction, modernization, or conversion and 
        operation of the project for a period of not less than 
        (A) twenty years in the case of a project assisted 
        under an allotment or grant under this title, or (B) 
        the term of repayment of a loan made or guaranteed 
        under this title in the case of a project assisted by a 
        loan or loan guarantee.
---------------------------------------------------------------------------
    \1\ So in law. The comma probably should follow the ending 
quotations.
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            (11) The term ``medical facility'' means a 
        hospital, public health center, outpatient medical 
        facility, rehabilitation facility, facility for long-
        term care, or other facility (as may be designated by 
        the Secretary) for the provision of health care to 
        ambulatory patients.
            (12) The term ``State Agency'' means the State 
        health planning and development agency of a State 
        designated under title XV.
            (13) The term ``urban or rural poverty area'' means 
        an urban or rural geographical area (as defined by the 
        Secretary) in which a percentage (as defined by the 
        Secretary in accordance with the next sentence) of the 
        residents of the area have incomes below the poverty 
        level (as defined by the Secretary of Commerce). The 
        percentage referred to in the preceding sentence shall 
        be defined so that the percentage of the population of 
        the United States residing in urban and rural poverty 
        areas is--
                    (A) not more than the percentage of the 
                total population of the United States with 
                incomes below the poverty level (as so defined) 
                plus five per centum, and
                    (B) not less than such percentage minus 
                five per centum.
            (14) The term ``medically underserved population'' 
        means the population of an urban or rural area 
        designated by the Secretary as an area with a shortage 
        of health facilities or a population group designated 
        by the Secretary as having a shortage of such 
        facilities.
                financial statements; records and audit
    Sec. 1625. [300s-4] (a) In the case of any facility for 
which an allotment payment, grant, loan, or loan guarantee has 
been made under this title, the applicant for such payment, 
grant, loan, or loan guarantee (or, if appropriate, such other 
person as the Secretary may prescribe) shall file at least 
annually with the State Agency for the State in which the 
facility is located a statement which shall be in such form, 
and contain such information, as the Secretary may require to 
accurately show--
            (1) the financial operations of the facility, and
            (2) the costs to the facility of providing health 
        services in the facility and the charges made by the 
        facility for providing such services,
during the period with respect to which the statement is filed.
    (b)(1) Each entity receiving Federal assistance under this 
title shall keep such records as the Secretary shall prescribe, 
including records which fully disclose the amount and 
disposition by such entity of the proceeds of such assistance, 
the total cost of the project in connection with which such 
assistance is given or used, the amount of that portion of the 
cost of the project supplied by other sources, and such other 
records as will facilitate an effective audit.
    (2) The Secretary and the Comptroller General of the United 
States, or any of their duly authorized representatives, shall 
have access for the purpose of audit and examination to any 
books, documents, papers, and records of such entities which in 
the opinion of the Secretary or the Comptroller General may be 
related or pertinent to the assistance referred to in paragraph 
(1).
    (c) Each such entity shall file at least annually with the 
Secretary a statement which shall be in such form, and contain 
such information, as the Secretary may require to accurately 
show--
            (1) the financial operations of the facility 
        constructed or modernized with such assistance, and
            (2) the costs to such facility of providing health 
        services in such facility, and the charges made for 
        such services, during the period with respect to which 
        the statement is filed.

                          technical assistance

    Sec. 1626. [300s-5] The Secretary shall provide (either 
through the Department of Health, Education, and Welfare or by 
contract) all necessary technical and other nonfinancial 
assistance to any public or other entity which is eligible to 
apply for assistance under this title to assist such entity in 
developing applications to be submitted to the Secretary under 
section 1621 or 1642. The Secretary shall make every effort to 
inform eligible applicants of the availability of assistance 
under this title.

                       enforcement of assurances

    Sec. 1627. [300s-6] The Secretary shall investigate and 
ascertain, on a periodic basis, with respect to each entity 
which is receiving financial assistance under this title or 
which has received financial assistance under title VI or this 
title, the extent of compliance by such entity with the 
assurances required to be made at the time such assistance was 
received. If the Secretary finds that such an entity has failed 
to comply with any such assurance, the Secretary shall report 
such noncompliance to the health systems agency for the health 
service area in which such entity is located and the State 
health planning and development agency of the State in which 
the entity is located and shall take any action authorized by 
law (including an action for specific performance brought by 
the Attorney General upon request of the Secretary) which will 
effect compliance by the entity with such assurances. An action 
to effectuate compliance with any such assurance may be brought 
by a person other than the Secretary only if a complaint has 
been filed by such person with the Secretary and the Secretary 
has dismissed such complaint or the Attorney General has not 
brought a civil action for compliance with such assurance 
within six months after the date on which the complaint was 
filed with the Secretary.

             Part D--Area Health Services Development Funds

     development grants for area health services development funds

    Sec. 1640. [300t] (a) The Secretary shall make in each 
fiscal year a grant to each health systems agency--
            (1) with which there is in effect a designation 
        agreement under section 1515(c),
            (2) which has in effect an HSP and AIP reviewed by 
        the Statewide Health Coordinating Council, and
            (3) which, as determined under the review made 
        under section 1535(c), is organized and operated in the 
        manner prescribed by section 1512(b) and is performing 
        its functions under section 1513 in a manner 
        satisfactory to the Secretary,
to enable the agency to establish and maintain an Area Health 
Services Development Fund from which it may make grants and 
enter into contracts in accordance with section 1513(c)(3).
    (b)(1) Except as provided in paragraph (2), the amount of 
any grant under subsection (a) shall be determined by the 
Secretary after taking into consideration the population of the 
health service area for which the health systems agency is 
designated, the average family income of the area, and the 
supply of health services in the area.
    (2) The amount of any grant under subsection (a) to a 
health systems agency for any fiscal year may not exceed the 
product of $1 and the population of the health service area for 
which such agency is designated.
    (c) No grant may be made under subsection (a) unless an 
application therefor has been submitted to, and approved by, 
the Secretary. Such an application shall be submitted in such 
form and manner and contain such information as the Secretary 
may require.
    (d) For the purpose of making payments pursuant to grants 
under subsection (a), there are authorized to be appropriated 
$25,000,000 for the fiscal year ending June 30, 1975, 
$75,000,000 for the fiscal year ending June 30, 1976, 
$120,000,000 each for the fiscal years ending September 30, 
1977, and September 30, 1978, $20,000,000 for the fiscal year 
ending September 30, 1981, and $30,000,000 for the fiscal year 
ending September 30, 1982.

Part E--Program To Assist and Encourage the Voluntary Discontinuance of 
  Unneeded Hospital Services and the Conversion of Unneeded Hospital 
       Services to Other Health Services Needed by the Community

                        establishment of program

    Sec. 1641. [300t-11] The Secretary shall, by April 1, 1980, 
establish a program under which--
            (1) grants and technical assistance may be provided 
        to hospitals in operation on the date of the enactment 
        of this part (A) for the discontinuance of unneeded 
        hospital services, and (B) for the conversion of 
        unneeded hospital services to other health services 
        needed by the community; and
            (2) grants may be provided to State Agencies 
        designated under section 1521(b)(3) for reducing 
        excesses in resources and facilities of hospitals.

                grants for discontinuance and conversion

    Sec. 1642. [300t-12] (a)(1) A grant to a hospital under the 
program shall be subject to such terms and conditions as the 
Secretary may by regulation prescribe to assure that the grant 
is used for the purpose for which it was made.
    (2) The amount of any such grant shall be determined by the 
Secretary. The recipient of such a grant may use the grant--
            (A) in the case of a grantee which discontinues the 
        provision of all hospital services or all inpatient 
        hospital services or an identifiable part of a hospital 
        facility which provides inpatient hospital services, 
        for the liquidation of the outstanding debt on the 
        facilities of the grantee used for the provision of the 
        services or for the liquidation of the outstanding debt 
        of the grantee on such identifiable part;
            (B) in the case of a grantee which is discontinuing 
        the provision of an inpatient hospital service converts 
        or proposes to convert an identifiable part of a 
        hospital facility used in the provision of the 
        discontinued service to the delivery of other health 
        services, for the planning, development (including 
        construction and acquisition of equipment), and 
        delivery of the health service;
            (C) to provide reasonable termination pay for 
        personnel of the grantee who will lose employment 
        because of the discontinuance of hospital services made 
        by the grantee, retraining of such personnel, assisting 
        such personnel in securing employment, and other costs 
        of implementing arrangements described in subsection 
        (c); and
            (D) for such other costs which the Secretary 
        determines may need to be incurred by the grantee in 
        discontinuing hospital services.
    (b)(1) No grant may be made to a hospital unless an 
application therefor is submitted to and approved by the 
Secretary. Such an application shall be in such form and 
submitted in such manner as the Secretary may prescribe and 
shall include--
            (A) a description of each service to be 
        discontinued and, if a part of a hospital is to be 
        discontinued or converted to another use in connection 
        with such discontinuance, a description of such part;
            (B) an evaluation of the impact of such 
        discontinuance and conversion on the provision of 
        health care in the health service area in which such 
        service is provided;
            (C) an estimate of the change in the applicant's 
        costs which will result from such discontinuance and 
        conversion; and
            (D) reasonable assurance that all laborers and 
        mechanics employed by contractors or subcontractors in 
        the performance of work on a project will be paid wages 
        at rates not less than those prevailing on similar 
        construction in the locality as determined by the 
        Secretary of Labor in accordance with the Act of March 
        3, 1931 (40 U.S.C. 276a--276a-5, known as the Davis-
        Bacon Act), and the Secretary of Labor shall have with 
        respect to such labor standards the authority and 
        functions set forth in Reorganization Plan Numbered 14 
        of 1950 (15 FR 3176; 5 U.S.C. Appendix) and section 2 
        of the Act of June 13, 1934 (40 U.S.C. 276c);
            (E) such other information as the Secretary may 
        require.
    (2)(A) The health systems agency for the health service 
area in which is located a hospital applying for a grant under 
the program shall (i) in making the review of the applicant's 
application under section 1513(e), determine the need for each 
service or part proposed to be discontinued by the applicant, 
(ii) in the case of an application for the conversion of a 
facility, determine the need for each service which will be 
provided as a result of a conversion, and (iii) make a 
recommendation to the State Agency for the State in which the 
applicant is located respecting approval by the Secretary of 
the applicant's application.
    (B) A State Agency which has received a recommendation from 
a health systems agency under subparagraph (A) respecting an 
application shall, after consideration of such recommendation, 
make a recommendation to the Secretary respecting the approval 
by the Secretary of the application. A State Agency's 
recommendation under this subparagraph respecting the approval 
of an application (i) shall be based upon (I) the need for each 
service or part proposed to be discontinued by the applicant, 
(II) in the case of an application for the conversion of a 
facility, the need for each service which will be provided as a 
result of the conversion, and (III) such other criteria as the 
Secretary may prescribe, and (ii) shall be accompanied by the 
health systems agency's recommendation made with respect to the 
approval of the application.
    (C) In determining, under subparagraphs (A) and (B), the 
need for the service (or services) or part proposed to be 
discontinued or converted by an applicant for a grant, a health 
systems agency and State Agency shall give special 
consideration to the unmet needs and existing access patterns 
of urban or rural poverty populations.
    (3)(A) The Secretary may not approve an application of a 
hospital for a grant--
            (i) if a State Agency recommended that the 
        application not be approved, or
            (ii) if the Secretary is unable to determine that 
        the cost of providing inpatient health services in the 
        health service area in which the applicant is located 
        will be less than if the inpatient health services 
        proposed to be discontinued were not discontinued.
    (B) In considering applications of hospitals for grants the 
Secretary shall consider the recommendations of health systems 
agencies and State Agencies and shall give special 
consideration to applications (i) which will assist health 
systems agencies and State Agencies to meet the goals in their 
health systems plans and State health plans, or (ii) which will 
result in the greatest reduction in hospital costs within a 
health service area.
    (c)(1) Except as provided in paragraph (3), the Secretary 
may not approve an application submitted under subsection (b) 
unless the Secretary of Labor has certified that fair and 
equitable arrangements have been made to protect the interests 
of employees affected by the discontinuance of services against 
a worsening of their positions with respect to their 
employment, including arrangements to preserve the rights of 
employees under collective-bargaining agreements, continuation 
of collective-bargaining rights consistent with the provisions 
of the National Labor Relations Act, reassignment of affected 
employees to other jobs, retraining programs, protecting 
pension, health benefits, and other fringe benefits of affected 
employees, and arranging adequate severance pay, if necessary.
    (2) The Secretary of Labor shall by regulation prescribe 
guidelines for arrangements for the protection of the interests 
of employees affected by the discontinuance of hospital 
services. The Secretary of Labor shall consult with the 
Secretary of Health, Education, and Welfare in the promulgation 
of such guidelines. Such guidelines shall first be promulgated 
not later than the promulgation of regulations by the Secretary 
for the administration of the grants authorized by section 
1641.
    (3) The Secretary of Labor shall review each application 
submitted under subsection (b) to determine if the arrangements 
described in paragraph (1) have been made and if they are 
satisfactory and shall notify the Secretary respecting his 
determination. Such review shall be completed within--
            (A) ninety days from the date of the receipt of the 
        application from the Secretary of Health, Education, 
        and Welfare, or
            (B) one hundred and twenty days from such date if 
        the Secretary of Labor has by regulation prescribed the 
        circumstances under which the review will require at 
        least one hundred and twenty days.
If within the applicable period, the Secretary of Labor does 
not notify the Secretary of Health, Education, and Welfare 
respecting his determination, the Secretary of Health, 
Education, and Welfare shall review the application to 
determine if the applicant has made the arrangements described 
in paragraph (1) and if such arrangements are satisfactory. The 
Secretary may not approve the application unless he determines 
that such arrangements have been made and that they are 
satisfactory.
    (d) The records and audits requirements of section 705 
shall apply with respect to grants made under subsection (a).
    (e) For purposes of this part, the term ``hospital'' means, 
with respect to any fiscal year, an institution (including a 
distinct part of an institution participating in the programs 
established under title XVIII of the Social Security Act)--
            (1) which satisfies paragraphs (1) and (7) of 
        section 1861(e) of such Act,
            (2) imposes charges or accepts payments for 
        services provided to patients, and
            (3) the average duration of a patient's stay in 
        which was thirty days or less in the preceding fiscal 
        year,
but such term does not include a Federal hospital or a 
psychiatric hospital (as described in section 1861(f)(1) of the 
Social Security Act).

       grants to states for reduction of excess hospital capacity

    Sec. 1643. [300t-13] (a) For the purpose of demonstrating 
the effectiveness of various means for reducing excesses in 
resources and facilities of hospitals (referred to in this 
section as ``excess hospital capacity''), the Secretary may 
make grants to State Agencies designated under section 
1521(b)(3) to assist such Agencies in--
            (1) identifying (by geographic region or by health 
        service) excess hospital capacity,
            (2) developing programs to inform the public of the 
        costs associated with excess hospital capacity,
            (3) developing programs to reduce excess hospital 
        capacity in a manner which will produce the greatest 
        savings in the cost of health care delivery,
            (4) developing means to overcome barriers to the 
        reduction of excess hospital capacity,
            (5) in planning, evaluating, and carrying out 
        programs to decertify health care facilities providing 
        health services that are not appropriate, and
            (6) any other activity related to the reduction of 
        excess hospital capacity.
    (b) Grants under subsection (a) shall be made on such terms 
and conditions as the Secretary may prescribe.

                    authorization of appropriations

    Sec. 1644. [300t-14] To make payments under grants under 
sections 1642 and 1643 there are authorized to be appropriated 
$30,000,000 for the fiscal year ending September 30, 1980, 
$50,000,000 for the fiscal year ending September 30, 1981, and 
$75,000,000 for the fiscal year ending September 30, 1982, 
except that in any fiscal year not more than 10 percent of the 
amount appropriated under this section may be obligated for 
grants under section 1643.ATTORNEY: CAS (March 29, 
2000) deg.
          TITLE XVII--HEALTH INFORMATION AND HEALTH PROMOTION

                           general authority

    Sec. 1701. [300u] (a) The Secretary shall--
            (1) formulate national goals, and a strategy to 
        achieve such goals, with respect to health information 
        and health promotion, preventive health services, and 
        education in the appropriate use of health care;
            (2) analyze the necessary and available resources 
        for implementing the goals and strategy formulated 
        pursuant to paragraph (1), and recommend appropriate 
        educational and quality assurance policies for the 
        needed manpower resources identified by such analysis;
            (3) undertake and support necessary activities and 
        programs to--
                    (A) incorporate appropriate health 
                education components into our society, 
                especially into all aspects of education and 
                health care,
                    (B) increase the application and use of 
                health knowledge, skills, and practices by the 
                general population in its patterns of daily 
                living, and
                    (C) establish systematic processes for the 
                exploration, development, demonstration, and 
                evaluation of innovative health promotion 
                concepts;
            (4) undertake and support research and 
        demonstrations respecting health information and health 
        promotion, preventive health services, and education in 
        the appropriate use of health care;
            (5) undertake and support appropriate training in 
        the operation of programs concerned with, health 
        information and health promotion, preventive health 
        services, and education in the appropriate use of 
        health care;
            (6) undertake and support, through improved 
        planning and implementation of tested models and 
        evaluation of results, effective and efficient programs 
        respecting health information and health promotion, 
        preventive health services, and education in the 
        appropriate use of health care;
            (7)(A) develop model programs through which 
        employers in the public sector, and employers that are 
        small businesses (as defined in section 3 of the Small 
        Business Act), can provide for their employees a 
        program to promote healthy behaviors and to discourage 
        participation in unhealthy behaviors;
            (B) provide technical assistance to public and 
        private employers in implementing such programs 
        (including private employers that are not small 
        businesses and that will implement programs other than 
        the programs developed by the Secretary pursuant to 
        subparagraph (A)); and
            (C) in providing such technical assistance, give 
        preference to small businesses;
            (8) foster the exchange of information respecting, 
        and foster cooperation in the conduct of, research, 
        demonstration, and training programs respecting health 
        information and health promotion, preventive health 
        services, and education in the appropriate use of 
        health care;
            (9) provide technical assistance in the programs 
        referred to in paragraph (8);
            (10) use such other authorities for programs 
        respecting health information and health promotion, 
        preventive health services, and education in the 
        appropriate use of health care as are available and 
        coordinate such use with programs conducted under this 
        title; and
            (11) establish in the Office of the Assistant 
        Secretary for Health an Office of Disease Prevention 
        and Health Promotion, which shall--
                    (A) coordinate all activities within the 
                Department which relate to disease prevention, 
                health promotion, preventive health services, 
                and health information and education with 
                respect to the appropriate use of health care;
                    (B) coordinate such activities with similar 
                activities in the private sector;
                    (C) establish a national information 
                clearinghouse to facilitate the exchange of 
                information concerning matters relating to 
                health information and health promotion, 
                preventive health services (which may include 
                information concerning models and standards for 
                insurance coverage of such services), and 
                education in the appropriate use of health 
                care, to facilitate access to such information, 
                and to assist in the analysis of issues and 
                problems relating to such matters; and
                    (D) support projects, conduct research, and 
                disseminate information relating to preventive 
                medicine, health promotion, and physical 
                fitness and sports medicine.
The Secretary shall appoint a Director for the Office of 
Disease Prevention and Health Promotion established pursuant to 
paragraph (11) of this subsection. The Secretary shall 
administer this title in cooperation with health care 
providers, educators, voluntary organizations, businesses, and 
State and local health agencies in order to encourage the 
dissemination of health information and health promotion 
activities.
    (b) For the purpose of carrying out this section and 
sections 1702 through 1705, there are authorized to be 
appropriated $10,000,000 for fiscal year 1992, and such sums as 
may be necessary for each of the fiscal years 1993 through 
2002.
    (c) No grant may be made or contract entered into under 
this title unless an application therefor has been submitted to 
and approved by the Secretary. Such an application shall be 
submitted in such form and manner and contain such information 
as the Secretary may prescribe. Contracts may be entered into 
under this title without regard to sections 3648 and 3709 of 
the Revised Statutes (31 U.S.C. 529; 41 U.S.C. 5).

                           research programs

    Sec. 1702. [300u-1] (a) The Secretary is authorized to 
conduct and support by grant or contract (and encourage others 
to support) research in health information and health 
promotion, preventive health services, and education in the 
appropriate use of health care. Applications for grants and 
contracts under this section shall be subject to appropriate 
peer review. The Secretary shall also--
            (1) provide consultation and technical assistance 
        to persons who need help in preparing research 
        proposals or in actually conducting research;
            (2) determine the best methods of disseminating 
        information concerning personal health behavior, 
        preventive health services and the appropriate use of 
        health care and of affecting behavior so that such 
        information is applied to maintain and improve health, 
        and prevent disease, reduce its risk, or modify its 
        course or severity;
            (3) determine and study environmental, 
        occupational, social, and behavioral factors which 
        affect and determine health and ascertain those 
        programs and areas for which educational and preventive 
        measures could be implemented to improve health as it 
        is affected by such factors;
            (4) develop (A) methods by which the cost and 
        effectiveness of activities respecting health 
        information and health promotion, preventive health 
        services, and education in the appropriate use of 
        health care, can be measured, including methods for 
        evaluating the effectiveness of various settings for 
        such activities and the various types of persons 
        engaged in such activities, (B) methods for 
        reimbursement or payment for such activities, and (C) 
        models and standards for the conduct of such 
        activities, including models and standards for the 
        education, by providers of institutional health 
        services, of individuals receiving such services 
        respecting the nature of the institutional health 
        services provided the individuals and the symptoms, 
        signs, or diagnoses which led to provision of such 
        services;
            (5) develop a method for assessing the cost and 
        effectiveness of specific medical services and 
        procedures under various conditions of use, including 
        the assessment of the sensitivity and specificity of 
        screening and diagnostic procedures; and
            (6) enumerate and assess, using methods developed 
        under paragraph (5), preventive health measures and 
        services with respect to their cost and effectiveness 
        under various conditions of use (which measures and 
        services may include blood pressure screening, 
        cholesterol screening and control, smoking cessation 
        programs, substance abuse programs, cancer screening, 
        dietary and nutritional counseling, diabetes screening 
        and education, intraocular pressure screening, and 
        stress management).
    (b) The Secretary shall make a periodic survey of the 
needs, interest, attitudes, knowledge, and behavior of the 
American public regarding health and health care. The Secretary 
shall take into consideration the findings of such surveys and 
the findings of similar surveys conducted by national and 
community health education organizations, and other 
organizations and agencies for formulating policy respecting 
health information and health promotion, preventive health 
services, and education in the appropriate use of health care.

                           community programs

    Sec. 1703. [300u-2] (a) The Secretary is authorized to 
conduct and support by grant or contract (and encourage others 
to support) new and innovative programs in health information 
and health promotion, preventive health services, and education 
in the appropriate use of health care, and may specifically--
            (1) support demonstration and training programs in 
        such matters which programs (A) are in hospitals, 
        ambulatory care settings, home care settings, schools, 
        day care programs for children, and other appropriate 
        settings representative of broad cross sections of the 
        population, and include public education activities of 
        voluntary health agencies, professional medical 
        societies, and other private nonprofit health 
        organizations, (B) focus on objectives that are 
        measurable, and (C) emphasize the prevention or 
        moderation of illness or accidents that appear 
        controllable through individual knowledge and behavior;
            (2) provide consultation and technical assistance 
        to organizations that request help in planning, 
        operating, or evaluating programs in such matters;
            (3) develop health information and health promotion 
        materials and teaching programs including (A) model 
        curriculums for the training of educational and health 
        professionals and paraprofessionals in health education 
        by medical, dental, and nursing schools, schools of 
        public health, and other institutions engaged in 
        training of educational or health professionals, (B) 
        model curriculums to be used in elementary and 
        secondary schools and institutions of higher learning, 
        (C) materials and programs for the continuing education 
        of health professionals and paraprofessionals in the 
        health education of their patients, (D) materials for 
        public service use by the printed and broadcast media, 
        and (E) materials and programs to assist providers of 
        health care in providing health education to their 
        patients; and
            (4) support demonstration and evaluation programs 
        for individual and group self-help programs designed to 
        assist the participant in using his individual 
        capacities to deal with health problems, including 
        programs concerned with obesity, hypertension, and 
        diabetes.
    (b) The Secretary is authorized to make grants to States 
and other public and nonprofit entities to assist them in 
meeting the costs of demonstrating and evaluating programs 
which provide information respecting the costs and quality of 
health care or information respecting health insurance policies 
and prepaid health plans, or information respecting both. After 
the development of models pursuant to sections 1704(4) and 
1704(5) for such information, no grant may be made under this 
subsection for a program unless the information to be provided 
under the program is provided in accordance with one of such 
models applicable to the information.
    (c) The Secretary is authorized to support by grant or 
contract (and to encourage others to support) private nonprofit 
entities working in health information and health promotion, 
preventive health services, and education in the appropriate 
use of health care. The amount of any grant or contract for a 
fiscal year beginning after September 30, 1978, for an entity 
may not exceed 25 per centum of the expenses of entity for such 
fiscal year for health information and health promotion, 
preventive health services, and education in the appropriate 
use of health care.

                          information programs

    Sec. 1704. [300u-3] The Secretary is authorized to conduct 
and support by grant or contract (and encourage others to 
support) such activities as may be required to make information 
respecting health information and health promotion, preventive 
health services, and education in the appropriate use of health 
care available to the consumers of medical care, providers of 
such care, schools, and others who are or should be informed 
respecting such matters. Such activities may include at least 
the following:
            (1) The publication of information, pamphlets, and 
        other reports which are specially suited to interest 
        and instruct the health consumer, which information, 
        pamphlets, and other reports shall be updated annually, 
        shall pertain to the individual's ability to improve 
        and safeguard his own health; shall include material, 
        accompanied by suitable illustrations, on child care, 
        family life and human development, disease prevention 
        (particularly prevention of pulmonary disease, 
        cardiovascular disease, and cancer), physical fitness, 
        dental health, environmental health, nutrition, safety 
        and accident prevention, drug abuse and alcoholism, 
        mental health, management of chronic diseases 
        (including diabetes and arthritis), and venereal 
        diseases; and shall be designed to reach populations of 
        different languages and of different social and 
        economic backgrounds.
            (2) Securing the cooperation of the communication 
        media, providers of health care, schools, and others in 
        activities designed to promote and encourage the use of 
        health maintaining information and behavior.
            (3) The study of health information and promotion 
        in advertising and the making to concerned Federal 
        agencies and others such recommendations respecting 
        such advertising as are appropriate.
            (4) The development of models and standards for the 
        publication by States, insurance carriers, prepaid 
        health plans, and others (except individual health 
        practitioners) of information for use by the public 
        respecting the cost and quality of health care, 
        including information to enable the public to make 
        comparisons of the cost and quality of health care.
            (5) The development of models and standards for the 
        publication by States, insurance carriers, prepaid 
        health plans, and others of information for use by the 
        public respecting health insurance policies and prepaid 
        health plans, including information on the benefits 
        provided by the various types of such policies and 
        plans, the premium charges for such policies and plans, 
        exclusions from coverage or eligibility for coverage, 
        cost sharing requirements, and the ratio of the amounts 
        paid as benefits to the amounts received as premiums 
        and information to enable the public to make relevant 
        comparisons of the costs and benefits of such policies 
        and plans.

                            report and study

    Sec. 1705. [300u-4] (a) The Secretary shall, not later than 
two years after the date of the enactment of this title and 
biannually thereafter, submit to the President for transmittal 
to Congress a report on the status of health information and 
health promotion, preventive health services, and education in 
the appropriate use of health care. Each such report shall 
include--
            (1) a statement of the activities carried out under 
        this title since the last report and the extent to 
        which each such activity achieves the purposes of this 
        title;
            (2) an assessment of the manpower resources needed 
        to carry out programs relating to health information 
        and health promotion, preventive health services, and 
        education in the appropriate use of health care, and a 
        statement describing the activities currently being 
        carried out under this title designed to prepare 
        teachers and other manpower for such programs;
            (3) the goals and strategy formulated pursuant to 
        section 1701(a)(1), the models and standards developed 
        under this title, and the results of the study required 
        by subsection (b) of this section; and
            (4) such recommendations as the Secretary considers 
        appropriate for legislation respecting health 
        information and health promotion, preventive health 
        services, and education in the appropriate use of 
        health care, including recommendations for revisions to 
        and extension of this title.
    (b) The Secretary shall conduct a study of health education 
services and preventive health services to determine the 
coverage of such services under public and private health 
insurance programs, including the extent and nature of such 
coverage and the cost sharing requirements required by such 
programs for coverage of such services.

centers for research and demonstration of health promotion and disease 
                               prevention

    Sec. 1706. [300u-5] (a) The Secretary shall make grants or 
enter into contracts with academic health centers for the 
establishment, maintenance, and operation of centers for 
research and demonstration with respect to health promotion and 
disease prevention. Centers established, maintained, or 
operated under this section shall undertake research and 
demonstration projects in health promotion, disease prevention, 
and improved methods of appraising health hazards and risk 
factors, and shall serve as demonstration sites for the use of 
new and innovative research in public health techniques to 
prevent chronic diseases.
    (b) Each center established, maintained, or operated under 
this section shall--
            (1) be located in an academic health center with--
                    (A) a multidisciplinary faculty with 
                expertise in public health and which has 
                working relationships with relevant groups in 
                such fields as medicine, psychology, nursing, 
                social work, education and business;
                    (B) graduate training programs relevant to 
                disease prevention;
                    (C) a core faculty in epidemiology, 
                biostatistics, social sciences, behavioral and 
                environmental health sciences, and health 
                administration;
                    (D) a demonstrated curriculum in disease 
                prevention;
                    (E) a capability for residency training in 
                public health or preventive medicine; and
                    (F) such other qualifications as the 
                Secretary may prescribe;
            (2) conduct--
                    (A) health promotion and disease prevention 
                research, including retrospective studies and 
                longitudinal prospective studies in population 
                groups and communities;
                    (B) demonstration projects for the delivery 
                of services relating to health promotion and 
                disease prevention to defined population groups 
                using, as appropriate, community outreach and 
                organization techniques and other methods of 
                educating and motivating communities; and
                    (C) evaluation studies on the efficacy of 
                demonstration projects conducted under 
                subparagraph (B) of this paragraph.
The design of any evaluation study conducted under subparagraph 
(C) shall be established prior to the commencement of the 
demonstration project under subparagraph (B) for which the 
evaluation will be conducted.
    (c)(1) In making grants and entering into contracts under 
this section, the Secretary shall provide for an equitable 
geographical distribution of centers established, maintained, 
and operated under this section and for the distribution of 
such centers among areas containing a wide range of population 
groups which exhibit incidences of diseases which are most 
amenable to preventive intervention.
    (2) The Secretary, through the Director of the Centers for 
Disease Control and Prevention and in consultation with the 
Director of the National Institutes of Health, shall establish 
procedures for the appropriate peer review of applications for 
grants and contracts under this section by peer review groups 
composed principally of non-Federal experts.
    (d) For purposes of this section, the term ``academic 
health center'' means a school of medicine, a school of 
osteopathy, or a school of public health, as such terms are 
defined in section 701(4).
    (e) For the purpose of carrying out this section, there are 
authorized to be appropriated $10,000,000 for fiscal year 1992, 
and such sums as may be necessary for each of the fiscal years 
1993 through 2003.
                       office of minority health
    Sec. 1707. [300u-6] (a) In General.--There is established 
an Office of Minority Health. The Office of Minority Health as 
existing on the date of enactment of the Patient Protection and 
Affordable Care Act shall be transferred to the Office of the 
Secretary in such manner that there is established in the 
Office of the Secretary, the Office of Minority Health, which 
shall be headed by the Deputy Assistant Secretary for Minority 
Health who shall report directly to the Secretary, and shall 
retain and strengthen authorities (as in existence on such date 
of enactment) for the purpose of improving minority health and 
the quality of health care minorities receive, and eliminating 
racial and ethnic disparities. In carrying out this subsection, 
the Secretary, acting through the Deputy Assistant Secretary, 
shall award grants, contracts, enter into memoranda of 
understanding, cooperative, interagency, intra-agency and other 
agreements with public and nonprofit private entities, 
agencies, as well as Departmental and Cabinet agencies and 
organizations, and with organizations that are indigenous human 
resource providers in communities of color to assure improved 
health status of racial and ethnic minorities, and shall 
develop measures to evaluate the effectiveness of activities 
aimed at reducing health disparities and supporting the local 
community. Such measures shall evaluate community outreach 
activities, language services, workforce cultural competence, 
and other areas as determined by the Secretary.
    (b) Duties.--With respect to improving the health of racial 
and ethnic minority groups, the Secretary, acting through the 
Deputy Assistant Secretary for Minority Health (in this section 
referred to as the ``Deputy Assistant Secretary''), shall carry 
out the following:
            (1) Establish short-range and long-range goals and 
        objectives and coordinate all other activities within 
        the Public Health Service that relate to disease 
        prevention, health promotion, service delivery, and 
        research concerning such individuals. The heads of each 
        of the agencies of the Service shall consult with the 
        Deputy Assistant Secretary to ensure the coordination 
        of such activities.
            (2) Enter into interagency agreements with other 
        agencies of the Public Health Service.
            (3) Support research, demonstrations and 
        evaluations to test new and innovative models.
            (4) Increase knowledge and understanding of health 
        risk factors.
            (5) Develop mechanisms that support better 
        information dissemination, education, prevention, and 
        service delivery to individuals from disadvantaged 
        backgrounds, including individuals who are members of 
        racial or ethnic minority groups.
            (6) Ensure that the National Center for Health 
        Statistics collects data on the health status of each 
        minority group.
            (7) With respect to individuals who lack 
        proficiency in speaking the English language, enter 
        into contracts with public and nonprofit private 
        providers of primary health services for the purpose of 
        increasing the access of the individuals to such 
        services by developing and carrying out programs to 
        provide bilingual or interpretive services.
            (8) Support a national minority health resource 
        center to carry out the following:
                    (A) Facilitate the exchange of information 
                regarding matters relating to health 
                information and health promotion, preventive 
                health services, and education in the 
                appropriate use of health care.
                    (B) Facilitate access to such information.
                    (C) Assist in the analysis of issues and 
                problems relating to such matters.
                    (D) Provide technical assistance with 
                respect to the exchange of such information 
                (including facilitating the development of 
                materials for such technical assistance).
            (9) Carry out programs to improve access to health 
        care services for individuals with limited proficiency 
        in speaking the English language. Activities under the 
        preceding sentence shall include developing and 
        evaluating model projects.
            (10) Advise in matters related to the development, 
        implementation, and evaluation of health professions 
        education in decreasing disparities in health care 
        outcomes, including cultural competency as a method of 
        eliminating health disparities.
    (c) Advisory Committee.--
            (1) In general.--The Secretary shall establish an 
        advisory committee to be known as the Advisory 
        Committee on Minority Health (in this subsection 
        referred to as the ``Committee'').
            (2) Duties.--The Committee shall provide advice to 
        the Deputy Assistant Secretary carrying out this 
        section, including advice on the development of goals 
        and specific program activities under paragraphs (1) 
        through (10) of subsection (b) for each racial and 
        ethnic minority group.
            (3) Chair.--The chairperson of the Committee shall 
        be selected by the Secretary from among the members of 
        the voting members of the Committee. The term of office 
        of the chairperson shall be 2 years.
            (4) Composition.--
                    (A) The Committee shall be composed of 12 
                voting members appointed in accordance with 
                subparagraph (B), and nonvoting, ex officio 
                members designated in subparagraph (C).
                    (B) The voting members of the Committee 
                shall be appointed by the Secretary from among 
                individuals who are not officers or employees 
                of the Federal Government and who have 
                expertise regarding issues of minority health. 
                The racial and ethnic minority groups shall be 
                equally represented among such members.
                    (C) The nonvoting, ex officio members of 
                the Committee shall be such officials of the 
                Department of Health and Human Services as the 
                Secretary determines to be appropriate.
            (5) Terms.--Each member of the Committee shall 
        serve for a term of 4 years, except that the Secretary 
        shall initially appoint a portion of the members to 
        terms of 1 year, 2 years, and 3 years.
            (6) Vacancies.--If a vacancy occurs on the 
        Committee, a new member shall be appointed by the 
        Secretary within 90 days from the date that the vacancy 
        occurs, and serve for the remainder of the term for 
        which the predecessor of such member was appointed. The 
        vacancy shall not affect the power of the remaining 
        members to execute the duties of the Committee.
            (7) Compensation.--Members of the Committee who are 
        officers or employees of the United States shall serve 
        without compensation. Members of the Committee who are 
        not officers or employees of the United States shall 
        receive compensation, for each day (including travel 
        time) they are engaged in the performance of the 
        functions of the Committee. Such compensation may not 
        be in an amount in excess of the daily equivalent of 
        the annual maximum rate of basic pay payable under the 
        General Schedule (under title 5, United States Code) 
        for positions above GS-15.
    (d) Certain Requirements Regarding Duties.--
            (1) Recommendations regarding language.--
                    (A) Proficiency in speaking english.--The 
                Deputy Assistant Secretary shall consult with 
                the Director of the Office of International and 
                Refugee Health, the Director of the Office of 
                Civil Rights, and the Directors of other 
                appropriate departmental entities regarding 
                recommendations for carrying out activities 
                under subsection (b)(9).
                    (B) Health professions education regarding 
                health disparities.--The Deputy Assistant 
                Secretary shall carry out the duties under 
                subsection (b)(10) in collaboration with 
                appropriate personnel of the Department of 
                Health and Human Services, other Federal 
                agencies, and other offices, centers, and 
                institutions, as appropriate, that have 
                responsibilities under the Minority Health and 
                Health Disparities Research and Education Act 
                of 2000.
            (2) Equitable allocation regarding activities.--In 
        carrying out subsection (b), the Secretary shall ensure 
        that services provided under such subsection are 
        equitably allocated among all groups served under this 
        section by the Secretary.
            (3) Cultural competency of services.--The Secretary 
        shall ensure that information and services provided 
        pursuant to subsection (b) are provided in the 
        language, educational, and cultural context that is 
        most appropriate for the individuals for whom the 
        information and services are intended.
    (e) Grants and Contracts Regarding Duties.--
            (1) In general.--In carrying out subsection (b), 
        the Secretary acting through the Deputy Assistant 
        Secretary may make awards of grants, cooperative 
        agreements, and contracts to public and nonprofit 
        private entities.
            (2) Process for making awards.--The Deputy 
        Assistant Secretary shall ensure that awards under 
        paragraph (1) are made, to the extent practical, only 
        on a competitive basis, and that a grant is awarded for 
        a proposal only if the proposal has been recommended 
        for such an award through a process of peer review.
            (3) Evaluation and dissemination.--The Deputy 
        Assistant Secretary, directly or through contracts with 
        public and private entities, shall provide for 
        evaluations of projects carried out with awards made 
        under paragraph (1) during the preceding 2 fiscal 
        years. The report shall be included in the report 
        required under subsection (f) for the fiscal year 
        involved.
    (f) Reports.--
            (1) In general.--Not later than February 1 of 
        fiscal year 1999 and of each second year thereafter, 
        the Secretary shall submit to the Committee on Energy 
        and Commerce of the House of Representatives, and to 
        the Committee on Labor and Human Resources of the 
        Senate, a report describing the activities carried out 
        under this section during the preceding 2 fiscal years 
        and evaluating the extent to which such activities have 
        been effective in improving the health of racial and 
        ethnic minority groups. Each such report shall include 
        the biennial reports submitted under sections 201(e)(3) 
        and 201(f)(2) for such years by the heads of the Public 
        Health Service agencies.
            (2) Agency reports.--Not later than February 1, 
        1999, and biennially thereafter, the heads of the 
        Public Health Service agencies shall submit to the 
        Deputy Assistant Secretary a report summarizing the 
        minority health activities of each of the respective 
        agencies.
    (g) Definition.--For purposes of this section:
            (1) The term ``racial and ethnic minority group'' 
        means American Indians (including Alaska Natives, 
        Eskimos, and Aleuts); Asian Americans; Native Hawaiians 
        and other Pacific Islanders; Blacks; and Hispanics.
            (2) The term ``Hispanic'' means individuals whose 
        origin is Mexican, Puerto Rican, Cuban, Central or 
        South American, or any other Spanish-speaking country.
    (h) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of fiscal 
years 2011 through 2016.

SEC. 1707A. [300U-6A] INDIVIDUAL OFFICES OF MINORITY HEALTH WITHIN THE 
                    DEPARTMENT.

    (a) In General.--The head of each agency specified in 
subsection (b)(1) shall establish within the agency an office 
to be known as the Office of Minority Health. The head of each 
such Office shall be appointed by the head of the agency within 
which the Office is established, and shall report directly to 
the head of the agency. The head of such agency shall carry out 
this section (as this section relates to the agency) acting 
through such Director.
    (b) Specified Agencies.--The agencies referred to in 
subsection (a) are the Centers for Disease Control and 
Prevention, the Health Resources and Services Administration, 
the Substance Abuse and Mental Health Services Administration, 
the Agency for Healthcare Research and Quality, the Food and 
Drug Administration, and the Centers for Medicare & Medicaid 
Services.
    (c) Director; Appointment.--Each Office of Minority Health 
established in an agency listed in subsection (a) shall be 
headed by a director, with documented experience and expertise 
in minority health services research and health disparities 
elimination.
    (d) References.--Except as otherwise specified, any 
reference in Federal law to an Office of Minority Health (in 
the Department of Health and Human Services) is deemed to be a 
reference to the Office of Minority Health in the Office of the 
Secretary.
    (e) Funding.--
            (1) Allocations.--Of the amounts appropriated for a 
        specified agency for a fiscal year, the Secretary must 
        designate an appropriate amount of funds for the 
        purpose of carrying out activities under this section 
        through the minority health office of the agency. In 
        reserving an amount under the preceding sentence for a 
        minority health office for a fiscal year, the Secretary 
        shall reduce, by substantially the same percentage, the 
        amount that otherwise would be available for each of 
        the programs of the designated agency involved.
            (2) Availability of funds for staffing.--The 
        purposes for which amounts made available under 
        paragraph may be expended by a minority health office 
        include the costs of employing staff for such office.
                      office of adolescent health
    Sec. 1708. [300u-7] (a) In General.--There is established 
an Office of Adolescent Health within the Office of the 
Assistant Secretary for Health, which office shall be headed by 
a director appointed by the Secretary. The Secretary shall 
carry out this section acting through the Director of such 
Office.
    (b) Duties.--With respect to adolescent health, the 
Secretary shall--
            (1) coordinate all activities within the Department 
        of Health and Human Services that relate to disease 
        prevention, health promotion, preventive health 
        services, and health information and education with 
        respect to the appropriate use of health care, 
        including coordinating--
                    (A) the design of programs, support for 
                programs, and the evaluation of programs;
                    (B) the monitoring of trends;
                    (C) projects of research (including 
                multidisciplinary projects) on adolescent 
                health; and
                    (D) the training of health providers who 
                work with adolescents, particularly nurse 
                practitioners, physician assistants, and social 
                workers;
            (2) coordinate the activities described in 
        paragraph (1) with similar activities in the private 
        sector; and
            (3) support projects, conduct research, and 
        disseminate information relating to preventive 
        medicine, health promotion, and physical fitness and 
        sports medicine.
    (c) Certain Demonstration Projects.--
            (1) In general.--In carrying out subsection (b)(3), 
        the Secretary may make grants to carry out 
        demonstration projects for the purpose of improving 
        adolescent health, including projects to train health 
        care providers in providing services to adolescents and 
        projects to reduce the incidence of violence among 
        adolescents, particularly among minority males.
            (2) Authorization of appropriations.--For the 
        purpose of carrying out paragraph (1), there are 
        authorized to be appropriated $5,000,000 for fiscal 
        year 1993, and such sums as may be necessary for each 
        of the fiscal years 1994 through 1997.
    (d) Information Clearinghouse.--In carrying out subsection 
(b), the Secretary shall establish and maintain a National 
Information Clearinghouse on Adolescent Health to collect and 
disseminate to health professionals and the general public 
information on adolescent health.
    (e) National Plan.--In carrying out subsection (b), the 
Secretary shall develop a national plan for improving 
adolescent health. The plan shall be consistent with the 
applicable objectives established by the Secretary for the 
health status of the people of the United States for the year 
2000, and shall be periodically reviewed, and as appropriate, 
revised. The plan, and any revisions in the plan, shall be 
submitted to the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Labor and Human 
Resources of the Senate.
    (f) Adolescent Health.--For purposes of this section, the 
term ``adolescent health'', with respect to adolescents of all 
ethnic and racial groups, means all diseases, disorders, and 
conditions (including with respect to mental health)--
            (1) unique to adolescents, or more serious or more 
        prevalent in adolescents;
            (2) for which the factors of medical risk or types 
        of medical intervention are different for adolescents, 
        or for which it is unknown whether such factors or 
        types are different for adolescents; or
            (3) with respect to which there has been 
        insufficient clinical research involving adolescents as 
        subjects or insufficient clinical data on adolescents.
             biennial report regarding nutrition and health
    Sec. 1709. [300u-8] (a) Biennial Report.--The Secretary 
shall require the Surgeon General of the Public Health Service 
to prepare biennial reports on the relationship between 
nutrition and health. Such reports may, with respect to such 
relationship, include any recommendations of the Secretary and 
the Surgeon General.
    (b) Submission to Congress.--The Secretary shall ensure 
that, not later than February 1 of 1995 and of every second 
year thereafter, a report under subsection (a) is submitted to 
the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Labor and Human Resources 
of the Senate.
                        education regarding des
    Sec. 1710. [300u-9] (a) In General.--The Secretary, acting 
through the heads of the appropriate agencies of the Public 
Health Service, shall carry out a national program for the 
education of health professionals and the public with respect 
to the drug diethylstilbestrol (commonly known as DES). To the 
extent appropriate, such national program shall use 
methodologies developed through the education demonstration 
program carried out under section 403C. In developing and 
carrying out the national program, the Secretary shall consult 
closely with representatives of nonprofit private entities that 
represent individuals who have been exposed to DES and that 
have expertise in community-based information campaigns for the 
public and for health care providers. The implementation of the 
national program shall begin during fiscal year 1999.
    (b) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 1999 through 2003. The authorization of 
appropriations established in the preceding sentence is in 
addition to any other authorization of appropriation that is 
available for such purpose.
 TITLE XVIII--PRESIDENT'S COMMISSION FOR THE STUDY OF ETHICAL PROBLEMS 
           IN MEDICINE AND BIOMEDICAL AND BEHAVIORAL RESEARCH

                      establishment of commission

    Sec. 1801. [300v] (a) Establishment.--(1) There is 
established the President's Commission for the Study of Ethical 
Problems in Medicine and Biomedical and Behavioral Research \1\ 
(hereinafter in this title referred to as the ``Commission'') 
which shall be composed of eleven members appointed by the 
President. The members of the Commission shall be appointed as 
follows:
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    \1\ Such a Commission was established on December 17, 1979, by 
Executive Order No. 12184 (44 Fed. Reg. 75091). The Executive Order was 
revoked on February 25, 1986, by Executive Order No. 12553 (51 Fed. 
Reg. 7237).
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            (A) Three of the members shall be appointed from 
        individuals who are distinguished in biomedical or 
        behavioral research.
            (B) Three of the members shall be appointed from 
        individuals who are distinguished in the practice of 
        medicine or otherwise distinguished in the provision of 
        health care.
            (C) Five of the members shall be appointed from 
        individuals who are distinguished in one or more of the 
        fields of ethics, theology, law, the natural sciences 
        (other than a biomedical or behavioral science), the 
        social sciences, the humanities, health administration, 
        government, and public affairs.
    (2) No individual who is a full-time officer or employee of 
the United States may be appointed as a member of the 
Commission. The Secretary of Health, Education, and Welfare, 
the Secretary of Defense, the Director of Central Intelligence, 
the Director of the Office of Science and Technology Policy, 
the Administrator of Veterans' Affairs, and the Director of the 
National Science Foundation shall each designate an individual 
to provide liaison with the Commission.
    (3) No individual may be appointed to serve as a member of 
the Commission if the individual has served for two terms of 
four years each as such a member.
    (4) A vacancy in the Commission shall be filled in the 
manner in which the original appointment was made.
    (b) Terms.--(1) Except as provided in paragraphs (2) and 
(3), members shall be appointed for terms of four years.
    (2) Of the members first appointed--
            (A) four shall be appointed for terms of three 
        years, and
            (B) three shall be appointed for terms of two 
        years,
as designated by the President at the time of appointment.
    (3) Any member appointed to fill a vacancy occurring before 
the expiration of the term for which his predecessor was 
appointed shall be appointed only for the remainder of such 
term. A member may serve after the expiration of his term until 
his successor has taken office.
    (c) Chairman.--The Chairman of the Commission shall be 
appointed by the President, by and with the advice and consent 
of the Senate, from members of the Commission.
    (d) Meetings.--(1) Seven members of the Commission shall 
constitute a quorum for business, but a lesser number may 
conduct hearings.
    (2) The Commission shall meet at the call of the Chairman 
or at the call of a majority of its members.
    (e) Compensation.--(1) Members of the Commission shall each 
be entitled to receive the daily equivalent of the annual rate 
of basic pay in effect for grade GS-18 of the General Schedule 
for each day (including travel time) during which they are 
engaged in the actual performance of duties vested in the 
Commission.
    (2) While away from their homes or regular places of 
business in the performance of services for the Commission, 
members of the Commission shall be allowed travel expenses, 
including per diem in lieu of subsistence, in the same manner 
as persons employed intermittently in the Government service 
are allowed expenses under section 5703 of title 5 of the 
United States Code.

                        duties of the commission

    Sec. 1802. [300v-1] (a) Studies.--(1) The Commission shall 
undertake studies of the ethical and legal implications of--
            (A) the requirements for informed consent to 
        participation in research projects and to otherwise 
        undergo medical procedures;
            (B) the matter of defining death, including the 
        advisability of developing a uniform definition of 
        death;
            (C) voluntary testing, counseling, and information 
        and education programs with respect to genetic diseases 
        and conditions, taking into account the essential 
        equality of all human beings, born and unborn;
            (D) the differences in the availability of health 
        services as determined by the income or residence of 
        the persons receiving the services;
            (E) current procedures and mechanisms designed (i) 
        to safeguard the privacy of human subjects of 
        behavioral and biomedical research, (ii) to ensure the 
        confidentiality of individually identifiable patient 
        records, and (iii) to ensure appropriate access of 
        patients to information continued \1\ in such records, 
        \2\ and
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    \1\ So in law. Probably should be ``contained''.
    \2\ So in law. The comma should probably be a semicolon.
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            (F) such other matters relating to medicine or 
        biomedical or behavioral research as the President may 
        designate for study by the Commission.
The Commission shall determine the priority and order of the 
studies required under this paragraph.
    (2) The Commission may undertake an investigation or study 
of any other appropriate matter which relates to medicine or 
biomedical or behavioral research (including the protection of 
human subjects of biomedical or behavioral research) and which 
is consistent with the purposes of this title on its own 
initiative or at the request of the head of the Federal agency.
    (3) In order to avoid duplication of effort, the Commission 
may, in lieu of, or as part of, any study or investigation 
required or otherwise conducted under this subsection, use a 
study or investigation conducted by another entity if the 
Commission sets forth its reasons for such use.
    (4) Upon the completion of each investigation or study 
undertaken by the Commission under this subsection (including a 
study or investigation which merely uses another study or 
investigation), it shall report its findings (including any 
recommendations for legislation or administrative action) to 
the President and the Congress and to each Federal agency to 
which a recommendation in the report applies.
    (b) Recommendations to Agencies.--(1) Within 60 days of the 
date a Federal agency receives a recommendation from the 
Commission that the agency take any action with respect to its 
rules, policies, guidelines, or regulations, the agency shall 
publish such recommendation in the Federal Register and shall 
provide opportunity for interested persons to submit written 
data, views, and arguments with respect to adoption of the 
recommendation.
    (2) Within the 180-day period beginning on the date of such 
publication, the agency shall determine whether the action 
proposed by such recommendation is appropriate, and, to the 
extent that it determines that--
            (A) such action is not appropriate, the agency 
        shall, within such time period, provide the Commission 
        with, and publish in the Federal Register, a notice of 
        such determination (including an adequate statement of 
        the reasons for the determination), or
            (B) such action is appropriate, the agency shall 
        undertake such action as expeditiously as feasible and 
        shall notify the Commission of the determination and 
        the action undertaken.
    (c) Report on Protection of Human Subjects.--The Commission 
shall biennially report to the President, the Congress, and 
appropriate Federal agencies on the protection of human 
subjects of biomedical and behavioral research. Each such 
report shall include a review of the adequacy and uniformity 
(1) of the rules, policies, guidelines, and regulations of all 
Federal agencies regarding the protection of human subjects of 
biomedical or behavioral research which such agencies conduct 
or support, and (2) of the implementation of such rules, 
policies, guidelines, and regulations by such agencies, and may 
include such recommendations for legislation and administrative 
action as the Commission deems appropriate.
    (d) Annual Report.--Not later than December 15 of each year 
(beginning with 1979) the Commission shall report to the 
President, the Congress, and appropriate Federal agencies on 
the activities of the Commission during the fiscal year ending 
in such year. Each such report shall include a complete list of 
all recommendations described in subsection (b)(1) made to 
Federal agencies by the Commission during the fiscal year and 
the actions taken, pursant \1\ to subsection (b)(2), by the 
agencies upon such recommendations, and may include such 
recommendations for legislation and administrative action as 
the Commission deems appropriate.
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    \1\ So in law. Probably should be ``pursuant''.
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    (e) Publications.--The Commission may at any time publish 
and disseminate to the public reports respecting its 
activities.
    (f) Definitions.--For purposes of this section:
            (1) The term ``Federal agency'' means an authority 
        of the government of the United States, but does not 
        include (A) the Congress, (B) the courts of the United 
        States, and (C) the government of the Commonwealth of 
        Puerto Rico, the government of the District of 
        Columbia, or the government of any territory or 
        possession of the United States.
            (2) The term ``protection of human subjects'' 
        includes the protection of the health, safety, and 
        privacy of individuals.

                       administrative provisions

    Sec. 1803. [300v-2] (a) Hearings.--The Commission may for 
the purpose of carrying out this title hold such hearings, sit 
and act at such times and places, take such testimony, and 
receive such evidence, as the Commission may deem advisable.
    (b) Staff.--(1) The Commission may appoint and fix the pay 
of such staff personnel as it deems desirable. Such personnel 
shall be appointed subject to the provisions of title 5, United 
States Code, governing appointments in the competitive service, 
and shall be paid in accordance with the provisions of chapter 
51 and subchapter III of chapter 53 of such title relating to 
classification and General Schedule pay rates.
    (2) The Commission may procure temporary and intermittent 
services to the same extent as is authorized by section 3109(b) 
of title 5 of the United States Code, but at rates for 
individuals not to exceed the daily equivalent of the annual 
rate of basis pay in effect for grade GS-18 of the General 
Schedule.
    (3) Upon request of the Commission, the head of any Federal 
agency is authorized to detail, on a reimbursable basis, any of 
the personnel of such agency to the Commission to assist it in 
carrying out its duties under this title.
    (c) Contracts.--The Commission, in performing its duties 
and functions under this title, may enter into contracts with 
appropriate public or nonprofit private entities. The authority 
of the Commission to enter into such contracts is effective for 
any fiscal year only to such extent or in such amounts as are 
provided in advance in appropriation Acts.
    (d) Information.--(1) The Commission may secure directly 
from any Federal agency information necessary to enable it to 
carry out this title. Upon request of the Chairman of the 
Commission, the head of such agency shall furnish such 
information to the Commission.
    (2) The Commission shall promptly arrange for such security 
clearances for its members and appropriate staff as are 
necessary to obtain access to classified information needed to 
carry out its duties under this title.
    (3) The Commission shall not disclose any information 
reported to or otherwise obtained by the Commission which is 
exempt from disclosure under subsection (a) of section 552 of 
title 5, United States Code, by reason of paragraphs (4) and 
(6) of subsection (b) of such section.
    (e) Support Services.--The Administrator of General 
Services shall provide to the Commission on a reimbursable 
basis such administrative support services as the Commission 
may request.

       authorization of appropriations; termination of commission

    Sec. 1804. [300v-3] (a) Authorizations.--To carry out this 
title there are authorized to be appropriated $5,000,000 for 
the fiscal year ending September 30, 1979, $5,000,000 for the 
fiscal year ending September 30, 1980, $5,000,000 for the 
fiscal year ending September 30, 1981, and $5,000,000 for the 
fiscal year ending September 30, 1982.
    (b) Federal Advisory Committee Act; Termination.--The 
Commission shall be subject to the Federal Advisory Committee 
Act, except that, under section 14(a)(1)(B) of such Act, the 
Commission shall terminate on December 31, 
1982.ATTORNEY: PMG/FD (June 22, 1999) deg.
                        TITLE XIX--BLOCK GRANTS

  H2  deg.Part A--Preventive Health and Health Services Block 
                                 Grant

            H3  deg.authorization of appropriations

    Sec. 1901. [300w] (a) For the purpose of allotments under 
section 1902, there are authorized to be appropriated 
$205,000,000 for fiscal year 1993, and such sums as may be 
necessary for each of the fiscal years 1994 through 1998.
    (b) Of the amount appropriated for any fiscal year under 
subsection (a), at least $7,000,000 shall be made available for 
allotments under section 1902(b).

                               allotments

    Sec. 1902. [300w-1] (a)(1) From the amounts appropriated 
under section 1901 for any fiscal year and available for 
allotment under this subsection, the Secretary shall allot to 
each State an amount which bears the same ratio to the 
available amounts for that fiscal year as the amounts provided 
by the Secretary under the provisions of law listed in 
paragraph (2) to the State and entities in the State for fiscal 
year 1981 bore to the total amount appropriated for such 
provisions of law for fiscal year 1981.
    (2) The provisions of law referred to in paragraph (1) are 
the following provisions of law as in effect on September 30, 
1981:
            (A) The authority for grants under section 317 for 
        preventive health service programs for the control of 
        rodents.
            (B) The authority for grants under section 317 for 
        establishing and maintaining community and school-based 
        fluoridation programs.
            (C) The authority for grants under section 317 for 
        preventive health service programs for hypertension.
            (D) Sections 401 and 402 of the Health Services and 
        Centers Amendments of 1978.
            (E) Section 314(d).
            (F) Section 339(a).
            (G) Sections 1202, 1203, and 1204.
    (b) From the amount required to be made available under 
section 1901(b) for allotments under this subsection for any 
fiscal year, the Secretary shall make allotments to each State 
on the basis of the population of the State.
    (c) To the extent that all the funds appropriated under 
section 1901 for a fiscal year and available for allotment in 
such fiscal year are not otherwise allotted to States because--
            (1) one or more States have not submitted an 
        application or description of activities in accordance 
        with section 1905 for the fiscal year;
            (2) one or more States have notified the Secretary 
        that they do not intend to use the full amount of their 
        allotment; or
            (3) some State allotments are offset or repaid 
        under section 1906(b)(3);
such excess shall be allotted among each of the remaining 
States in proportion to the amount otherwise allotted to such 
States for the fiscal year without regard to this subsection.
    (d)(1) If the Secretary--
            (A) receives a request from the governing body of 
        an Indian tribe or tribal organization within any State 
        that funds under this part be provided directly by the 
        Secretary to such tribe or organization, and
            (B) determines that the members of such tribe or 
        tribal organization would be better served by means of 
        grants made directly by the Secretary under this part,
the Secretary shall reserve from amounts which would otherwise 
be allotted to such State under subsection (a) for the fiscal 
year the amount determined under paragraph (2).
    (2) The Secretary shall reserve for the purpose of 
paragraph (1) from amounts that would otherwise be allotted to 
such State under subsection (a) an amount equal to the amount 
which bears the same ratio to the State's allotment for the 
fiscal year involved as the total amount provided or allotted 
for fiscal year 1981 by the Secretary to such tribe or tribal 
organization under the provisions of law referred to in 
subsection (a) bore to the total amount provided or allotted 
for such fiscal year by the Secretary to the State and entities 
(including Indian tribes and tribal organizations) in the State 
under such provisions of law.
    (3) The amount reserved by the Secretary on the basis of a 
determination under this subsection shall be granted to the 
Indian tribe or tribal organization serving the individuals for 
whom such a determination has been made.
    (4) In order for an Indian tribe or tribal organization to 
be eligible for a grant for a fiscal year under this 
subsection, it shall submit to the Secretary a plan for such 
fiscal year which meets such criteria as the Secretary may 
prescribe.
    (5) The terms ``Indian tribe'' and ``tribal organization'' 
have the same meaning given such terms in section 4(b) and 
section 4(c) of the Indian Self-Determination and Education 
Assistance Act.
    (e) The Secretary shall conduct a study for the purpose of 
devising a formula for the equitable distribution of funds 
available for allotment to the States under this section. In 
conducting the study, the Secretary shall take into account--
            (1) the financial resources of the various States,
            (2) the populations of the States, and
            (3) any other factor which the Secretary may 
        consider appropriate.
Before June 30, 1982, the Secretary shall submit a report to 
the Congress respecting the development of a formula and make 
such recommendations as the Secretary may deem appropriate in 
order to ensure the most equitable distribution of funds under 
allotments under this section.

                  payments under allotments to states

    Sec. 1903. [300w-2] (a)(1) For each fiscal year, the 
Secretary shall make payments, as provided by section 203 of 
the Intergovernmental Cooperation Act of 1968 (42 U.S.C. 4213), 
to each State from its allotment under section 1902 (other than 
any amount reserved under section 1902(d)) from amounts 
appropriated for that fiscal year.
    (2) Any amount paid to a State for a fiscal year and 
remaining unobligated at the end of such year shall remain 
available for the next fiscal year to such State for the 
purposes for which it was made.
    (b) The Secretary, at the request of a State, may reduce 
the amount of payments under subsection (a) by--
            (1) the fair market value of any supplies or 
        equipment furnished the State, and
            (2) the amount of the pay, allowances, and travel 
        expenses of any officer or employee of the Government 
        when detailed to the State and the amount of any other 
        costs incurred in connection with the detail of such 
        officer or employee,
when the furnishing of supplies or equipment or the detail of 
an officer or employee is for the convenience of and at the 
request of the State and for the purpose of conducting 
activities described in section 1904. The amount by which any 
payment is so reduced shall be available for payment by the 
Secretary of the costs incurred in furnishing the supplies or 
equipment or in detailing the personnel, on which the reduction 
of the payment is based, and the amount shall be deemed to be 
part of the payment and shall be deemed to have been paid to 
the State.

                           use of allotments

    Sec. 1904. [300w-3] (a)(1) Except as provided in 
subsections (b) and (c), payments made to a State under section 
1903 may be used for the following:
            (A) Activities consistent with making progress 
        toward achieving the objectives established by the 
        Secretary for the health status of the population of 
        the United States for the year 2000 (in this part 
        referred to as ``year 2000 health objectives'').
            (B) Preventive health service programs for the 
        control of rodents and for community and school-based 
        fluoridation programs.
            (C) Feasibility studies and planning for emergency 
        medical services systems and the establishment, 
        expansion, and improvement of such systems. Amounts for 
        such systems may not be used for the costs of the 
        operation of the systems or the purchase of equipment 
        for the systems, except that such amounts may be used 
        for the payment of not more than 50 percent of the 
        costs of purchasing communications equipment for the 
        systems. Amounts may be expended for feasibility 
        studies or planning for the trauma-care components of 
        such systems only if the studies or planning, 
        respectively, is consistent with the requirements of 
        section 1213(a).
            (D) Providing services to victims of sex offenses 
        and for prevention of sex offenses.
            (E) The establishment, operation, and coordination 
        of effective and cost-efficient systems to reduce the 
        prevalence of illness due to asthma and asthma-related 
        illnesses, especially among children, by reducing the 
        level of exposure to cockroach allergen or other known 
        asthma triggers through the use of integrated pest 
        management, as applied to cockroaches or other known 
        allergens. Amounts expended for such systems may 
        include the costs of building maintenance and the costs 
        of programs to promote community participation in the 
        carrying out at such sites of integrated pest 
        management, as applied to cockroaches or other known 
        allergens. For purposes of this subparagraph, the term 
        ``integrated pest management'' means an approach to the 
        management of pests in public facilities that combines 
        biological, cultural, physical, and chemical tools in a 
        way that minimizes economic, health, and environmental 
        risks.
            (F) With respect to activities described in any of 
        subparagraphs (A) through (E), related planning, 
        administration, and educational activities.
            (G) Monitoring and evaluation of activities carried 
        out under any of subparagraphs (A) through (F).
    (2) Except as provided in subsection (b), amounts paid to a 
State under section 1903 from its allotment under section 
1902(b) may only be used for providing services to rape victims 
and for rape prevention.
    (3) The Secretary may provide technical assistance to 
States in planning and operating activities to be carried out 
under this part.
    (b) A State may not use amounts paid to it under section 
1903 to--
            (1) provide inpatient services,
            (2) make cash payments to intended recipients of 
        health services,
            (3) purchase or improve land, purchase, construct, 
        or permanently improve (other than minor remodeling) 
        any building or other facility, or purchase major 
        medical equipment,
            (4) satisfy any requirement for the expenditure of 
        non-Federal funds as a condition for the receipt of 
        Federal funds, or
            (5) provide financial assistance to any entity 
        other than a public or nonprofit private entity.
Except as provided in subsection (a)(1)(E), the Secretary may 
waive the limitation contained in paragraph (3) upon the 
request of a State if the Secretary finds that there are 
extraordinary circumstances to justify the waiver and that 
granting the waiver will assist in carrying out this part.
    (c) A State may transfer not more than 7 percent of the 
amount allotted to the State under section 1902(a) for any 
fiscal year for use by the State under part B of this title and 
title V of the Social Security Act in such fiscal year as 
follows: At any time in the first three quarters of the fiscal 
year a State may transfer not more than 3 percent of the 
allotment of the State for the fiscal year for such use, and in 
the last quarter of a fiscal year a State may transfer for such 
use not more than the remainder of the amount of its allotment 
which may be transferred.
    (d) Of the amount paid to any State under section 1903, not 
more than 10 percent paid from each of its allotments under 
subsections (a) and (b) of section 1902 may be used for 
administering the funds made available under section 1903. The 
State will pay from non-Federal sources the remaining costs of 
administering such funds.
                  application for payments; state plan
    Sec. 1905. [300w-4] (a) In General.--The Secretary may make 
payments under section 1903 to a State for a fiscal year only 
if--
            (1) the State submits to the Secretary an 
        application for the payments;
            (2) the application contains a State plan in 
        accordance with subsection (b);
            (3) the application contains the certification 
        described in subsection (c);
            (4) the application contains such assurances as the 
        Secretary may require regarding the compliance of the 
        State with the requirements of this part (including 
        assurances regarding compliance with the agreements 
        described in subsection (c)); and
            (5) the application is in such form and is 
        submitted by such date as the Secretary may require.
    (b) State Plan.--A State plan required in subsection (a)(2) 
for a fiscal year is in accordance with this subsection if the 
plan meets the following conditions:
            (1) The plan is developed by the State agency with 
        principal responsibility for public health programs, in 
        consultation with the advisory committee established 
        pursuant to subsection (c)(2).
            (2) The plan specifies the activities authorized in 
        section 1904 that are to be carried out with payments 
        made to the State under section 1903, including a 
        specification of the year 2000 health objectives for 
        which the State will expend the payments.
            (3) The plan specifies the populations in the State 
        for which such activities are to be carried out.
            (4) The plan specifies any populations in the State 
        that have a disparate need for such activities.
            (5) With respect to each population specified under 
        paragraph (3), the plan contains a strategy for 
        expending such payments to carry out such activities to 
        make progress toward improving the health status of the 
        population, which strategy includes--
                    (A) a description of the programs and 
                projects to be carried out;
                    (B) an estimate of the number of 
                individuals to be served by the programs and 
                projects; and
                    (C) an estimate of the number of public 
                health personnel needed to carry out the 
                strategy.
            (6) The plan specifies the amount of such payments 
        to be expended for each of such activities and, with 
        respect to the activity involved--
                    (A) the amount to be expended for each 
                population specified under paragraph (3); and
                    (B) the amount to be expended for each 
                population specified under paragraph (4).
    (c) State Certification.--The certification referred to in 
subsection (a)(3) for a fiscal year is a certification to the 
Secretary by the chief executive officer of the State involved 
as follows:
            (1)(A) In the development of the State plan 
        required in subsection (a)(2)--
                    (i) the chief health officer of the State 
                held public hearings on the plan; and
                    (ii) proposals for the plan were made 
                public in a manner that facilitated comments 
                from public and private entities (including 
                Federal and other public agencies).
            (B) The State agrees that, if any revisions are 
        made in such plan during the fiscal year, the State 
        will, with respect to the revisions, hold hearings and 
        make proposals public in accordance with subparagraph 
        (A), and will submit to the Secretary a description of 
        the revisions.
            (2) The State has established an advisory committee 
        in accordance with subsection (d).
            (3) The State agrees to expend payments under 
        section 1903 only for the activities authorized in 
        section 1904.
            (4) The State agrees to expend such payments in 
        accordance with the State plan submitted under 
        subsection (a)(2) (with any revisions submitted to the 
        Secretary under paragraph (1)(B)), including making 
        expenditures to carry out the strategy contained in the 
        plan pursuant to subsection (b)(5).
            (5)(A) The State agrees that, in the case of each 
        population for which such strategy is carried out, the 
        State will measure the extent of progress being made 
        toward improving the health status of the population.
            (B) The State agrees that--
                    (i) the State will collect and report data 
                in accordance with section 1906(a); and
                    (ii) for purposes of subparagraph (A), 
                progress will be measured through use of each 
                of the applicable uniform data items developed 
                by the Secretary under paragraph (2) of such 
                section, or if no such items are applicable, 
                through use of the uniform criteria developed 
                by the Secretary under paragraph (3) of such 
                section.
            (6) With respect to the activities authorized in 
        section 1904, the State agrees to maintain State 
        expenditures for such activities at a level that is not 
        less than the average level of such expenditures 
        maintained by the State for the 2-year period preceding 
        the fiscal year for which the State is applying to 
        receive payments under section 1903.
            (7) The State agrees to establish reasonable 
        criteria to evaluate the effective performance of 
        entities that receive funds from such payments and 
        procedures for procedural and substantive independent 
        State review of the failure by the State to provide 
        funds for any such entity.
            (8) The State agrees to permit and cooperate with 
        Federal investigations undertaken in accordance with 
        section 1907.
            (9) The State has in effect a system to protect 
        from inappropriate disclosure patient and sex offense 
        victim records maintained by the State in connection 
        with an activity funded under this part or by any 
        entity which is receiving payments from the allotment 
        of the State under this part.
            (10) The State agrees to provide the officer of the 
        State government responsible for the administration of 
        the State highway safety program with an opportunity 
        to--
                    (A) participate in the development of any 
                plan by the State relating to emergency medical 
                services, as such plan relates to highway 
                safety; and
                    (B) review and comment on any proposal by 
                any State agency to use any Federal grant or 
                Federal payment received by the State for the 
                provision of emergency medical services as such 
                proposal relates to highway safety.
    (d) State Advisory Committee.--
            (1) In general.--For purposes of subsection (c)(2), 
        an advisory committee is in accordance with this 
        subsection if such committee is known as the State 
        Preventive Health Advisory Committee (in this 
        subsection referred to as the ``Committee'') and the 
        Committee meets the conditions described in the 
        subsequent paragraphs of this subsection.
            (2) Duties.--A condition under paragraph (1) for a 
        State is that the duties of the Committee are--
                    (A) to hold public hearings on the State 
                plan required in subsection (a)(2); and
                    (B) to make recommendations pursuant to 
                subsection (b)(1) regarding the development and 
                implementation of such plan, including 
                recommendations on--
                            (i) the conduct of assessments of 
                        the public health;
                            (ii) which of the activities 
                        authorized in section 1904 should be 
                        carried out in the State;
                            (iii) the allocation of payments 
                        made to the State under section 1903;
                            (iv) the coordination of activities 
                        carried out under such plan with 
                        relevant programs of other entities; 
                        and
                            (v) the collection and reporting of 
                        data in accordance with section 
                        1906(a).
            (3) Composition.--
                    (A) A condition under paragraph (1) for a 
                State is that the Committee is composed of such 
                members of the general public, and such 
                officials of the health departments of 
                political subdivisions of the State, as may be 
                necessary to provide adequate representation of 
                the general public and of such health 
                departments.
                    (B) With respect to compliance with 
                subparagraph (A), the membership of advisory 
                committees established pursuant to subsection 
                (c)(2) may include representatives of 
                community-based organizations (including 
                minority community-based organizations), 
                schools of public health, and entities to which 
                the State involved awards grants or contracts 
                to carry out activities authorized in section 
                1904.
            (4) Chair; meetings.--A condition under paragraph 
        (1) for a State is that the State public health officer 
        serves as the chair of the Committee, and that the 
        Committee meets not less than twice each fiscal year.

                       reports, data, and audits

    Sec. 1906. [300w-5] (a)(1) For purposes of section 
1905(c)(5)(B)(i), a State is collecting and reporting data for 
a fiscal year in accordance with this subsection if the State 
submits to the Secretary, not later than February 1 of the 
succeeding fiscal year, a report that--
            (A) describes the purposes for which the State 
        expended payments made to the State under section 1903;
            (B) pursuant to section 1905(c)(5)(A), describes 
        the extent of progress made by the State for purposes 
        of such section;
            (C) meets the conditions described in the 
        subsequent paragraphs of this subsection; and
            (D) contains such additional information regarding 
        activities authorized in section 1904, and is submitted 
        in such form, as the Secretary may require.
    (2)(A) The Secretary, in consultation with the States, 
shall develop sets of data for uniformly defining health status 
for purposes of the year 2000 health objectives (which sets are 
in this subsection referred to as ``uniform data sets''). Each 
of such sets shall consist of one or more categories of 
information (in this subsection individually referred to as a 
``uniform data item''). The Secretary shall develop formats for 
the uniform collecting and reporting of information on such 
items.
    (B) A condition under paragraph (1)(C) for a fiscal year is 
that the State involved will, in accordance with the applicable 
format under subparagraph (A), collect during such year, and 
include in the report under paragraph (1), the necessary 
information for one uniform data item from each of the uniform 
data sets, which items are selected for the State by the 
Secretary.
    (C) In the case of fiscal year 1995 and each subsequent 
fiscal year, a condition under paragraph (1) for a State is 
that the State will, in accordance with the applicable format 
under subparagraph (A), collect during such year, and include 
in the report under paragraph (1), the necessary information 
for each of the uniform data sets appropriate to the year 2000 
health objectives that the State has, in the State plan 
submitted under section 1905 for the fiscal year, specified as 
a purpose for which payments under section 1903 are to be 
expended.
    (3) The Secretary, in consultation with the States, shall 
establish criteria for the uniform collection and reporting of 
data on activities authorized in section 1904 with respect to 
which no uniform data items exist.
    (4) A condition under paragraph (1) for a fiscal year is 
that the State involved will make copies of the report 
submitted under such paragraph for the fiscal year available 
for public inspection, and will upon request provide a copy of 
the report to any individual for a charge not exceeding the 
cost of providing the copy.
    (b)(1) Each State shall establish fiscal control and fund 
accounting procedures as may be necessary to assure the proper 
disbursal of and accounting for Federal funds paid to the State 
under section 1903 and funds transferred under section 1904(c) 
for use under this part.
    (2) Each State shall annually audit its expenditures from 
payments received under section 1903. Such State audits shall 
be conducted by an entity independent of any agency 
administering a program funded under this part and, in so far 
as practical, in accordance with the Comptroller General's 
standards for auditing governmental organizations, programs, 
activities, and functions. Within 30 days following the date 
each audit is completed, the chief executive officer of the 
State shall transmit a copy of that audit to the Secretary.
    (3) Each State shall, after being provided by the Secretary 
with adequate notice and opportunity for a hearing within the 
State, repay to the United States amounts found not to have 
been expended in accordance with the requirements of this part 
or the certification provided by the State under section 1905. 
If such repayment is not made, the Secretary shall, after 
providing the State with adequate notice and opportunity for a 
hearing within the State, offset such amounts against the 
amount of any allotment to which the State is or may become 
entitled under this part.
    (4) The State shall make copies of the reports and audits 
required by this section available for public inspection within 
the State.
    (5) The Comptroller General of the United States shall, 
from time to time, evaluate the expenditures by States of 
grants under this part in order to assure that expenditures are 
consistent with the provisions of this part and the 
certification provided by the State under section 1905.
    (6) Not later than October 1, 1990, the Secretary shall 
report to the Congress on the activities of the States that 
have received funds under this part and may include in the 
report any recommendations for appropriate changes in 
legislation.
    (c) Title XVII of the Omnibus Budget Reconciliation Act of 
1981 shall not apply with respect to audits of funds allotted 
under this part.

                              withholding

    Sec. 1907. [300w-6] (a)(1) The Secretary shall, after 
adequate notice and an opportunity for a hearing conducted 
within the affected State, withhold funds from any State which 
does not use its allotment in accordance with the requirements 
of this part or the certification provided under section 1905. 
The Secretary shall withhold such funds until the Secretary 
finds that the reason for the withholding has been removed and 
there is reasonable assurance that it will not recur.
    (2) The Secretary may not institute proceedings to withhold 
funds under paragraph (1) unless the Secretary has conducted an 
investigation concerning whether the State has used its 
allotment in accordance with the requirements of this part or 
the certification provided under section 1905. Investigations 
required by this paragraph shall be conducted within the 
affected State by qualified investigators.
    (3) The Secretary shall respond in an expeditious manner to 
complaints of a substantial or serious nature that a State has 
failed to use funds in accordance with the requirements of this 
part or certifications provided under section 1905.
    (4) The Secretary may not withhold funds under paragraph 
(1) from a State for a minor failure to comply with the 
requirements of this part or certifications provided under 
section 1905.
    (b)(1) The Secretary shall conduct in several States in 
each fiscal year investigations of the use of funds received by 
the States under this part in order to evaluate compliance with 
the requirements of this part and certifications provided under 
section 1905.
    (2) The Comptroller General of the United States may 
conduct investigations of the use of funds received under this 
part by a State in order to insure compliance with the 
requirements of this part and certifications provided under 
section 1905.
    (c) Each State, and each entity which has received funds 
from an allotment made to a State under this part, shall make 
appropriate books, documents, papers, and records available to 
the Secretary or the Comptroller General of the United States, 
or any of their duly authorized representatives, for 
examination, copying, or mechanical reproduction on or off the 
premises of the appropriate entity upon a reasonable request 
therefor.
    (d)(1) In conducting any investigation in a State, the 
Secretary or the Comptroller General of the United States may 
not make a request for any information not readily available to 
such State or an entity which has received funds from an 
allotment made to the State under this part or make an 
unreasonable request for information to be compiled, collected, 
or transmitted in any form not readily available.
    (2) Paragraph (1) does not apply to the collection, 
compilation, or transmittal of data in the course of a judicial 
proceeding.

                           nondiscrimination

    Sec. 1908. [300w-7] (a)(1) For the purpose of applying the 
prohibitions against discrimination on the basis of age under 
the Age Discrimination Act of 1975, on the basis of handicap 
under section 504 of the Rehabilitation Act of 1973, on the 
basis of sex under title IX of the Education Amendments of 
1972, or on the basis of race, color, or national origin under 
title VI of the Civil Rights Act of 1964, programs and 
activities funded in whole or in part with funds made available 
under this part are considered to be programs and activities 
receiving Federal financial assistance.
    (2) No person shall on the ground of sex or religion be 
excluded from participation in, be denied the benefits of, or 
be subjected to discrimination under, any program or activity 
funded in whole or in part with funds made available under this 
part.
    (b) Whenever the Secretary finds that a State, or an entity 
that has received a payment from an allotment to a State under 
section 1902, has failed to comply with a provision of law 
referred to in subsection (a)(1), with subsection (a)(2), or 
with an applicable regulation (including one prescribed to 
carry out subsection (a)(2)), the Secretary shall notify the 
chief executive officer of the State and shall request him to 
secure compliance. If within a reasonable period of time, not 
to exceed sixty days, the chief executive officer fails or 
refuses to secure compliance, the Secretary may--
            (1) refer the matter to the Attorney General with a 
        recommendation that an appropriate civil action be 
        instituted,
            (2) exercise the powers and functions provided by 
        title VI of the Civil Rights Act of 1964, the Age 
        Discrimination Act of 1975, or section 504 of the 
        Rehabilitation Act of 1973, as may be applicable, or
            (3) take such other action as may be provided by 
        law.
    (c) When a matter is referred to the Attorney General 
pursuant to subsection (b)(1), or whenever he has reason to 
believe that a State or an entity is engaged in a pattern or 
practice in violation of a provision of law referred to in 
subsection (a)(1) or in violation of subsection (a)(2), the 
Attorney General may bring a civil action in any appropriate 
district court of the United States for such relief as may be 
appropriate, including injunctive relief.

                 criminal penalty for false statements

    Sec. 1909. [300w-8] Whoever--
            (1) knowingly and willfully makes or causes to be 
        made any false statement or representation of a 
        material fact in connection with the furnishing of 
        items or services for which payment may be made by a 
        State from funds allotted to the State under this part, 
        or
            (2) having knowledge of the occurrence of any event 
        affecting his initial or continued right to any such 
        payment conceals or fails to disclose such event with 
        an intent fraudulently to secure such payment either in 
        a greater amount than is due or when no such payment is 
        authorized,
shall be fined not more than $25,000 or imprisoned for not more 
than five years, or both.

                emergency medical services for children

    Sec. 1910. [300w-9] (a) For activities in addition to the 
activities which may be carried out by States under section 
1904(a)(1)(F), the Secretary may make grants to States or 
accredited schools of medicine in States to support a program 
of demonstration projects for the expansion and improvement of 
emergency medical services for children who need treatment for 
trauma or critical care. Any grant made under this subsection 
shall be for not more than a 4-year period (with an optional 
5th year based on performance), subject to annual evaluation by 
the Secretary. Only 3 grants under this subsection may be made 
in a State (to a State or to a school of medicine in such 
State) in any fiscal year.
    (b) The Secretary may renew a grant made under subsection 
(a) for one additional one-year period only if the Secretary 
determines that renewal of such grant will provide significant 
benefits through the collection, analysis, and dissemination of 
information or data which will be useful to States in which 
grants under such subsection have not been made.
      (c) For purposes of this section--
            (1) the term ``school of medicine'' has the same 
        meaning as in section 701(4); and
            (2) the term ``accredited'' has the same meaning as 
        in section 701(5).
    (d) To carry out this section, there are authorized to be 
appropriated $2,000,000 for fiscal year 1985 and for each of 
the two succeeding fiscal years, $3,000,000 for fiscal year 
1989, $4,000,000 for fiscal year 1990, $5,000,000 for each of 
the fiscal years 1991 and 1992, such sums as may be necessary 
for each of the fiscal years 1993 through 2005, $25,000,000 for 
fiscal year 2010, $26,250,000 for fiscal year 2011, $27,562,500 
for fiscal year 2012, $28,940,625 for fiscal year 2013, and 
$30,387,656 for fiscal year 2014.

    Part B--Block Grants Regarding Mental Health and Substance Abuse

      Subpart I--Block Grants for Community Mental Health Services

 H4  deg.SEC. 1911. [300X] FORMULA GRANTS TO STATES.

    (a) In General.--For the purpose described in subsection 
(b), the Secretary, acting through the Director of the Center 
for Mental Health Services, shall make an allotment each fiscal 
year for each State in an amount determined in accordance with 
section 1918. The Secretary shall make a grant to the State of 
the allotment made for the State for the fiscal year if the 
State submits to the Secretary an application in accordance 
with section 1917.
    (b) Purpose of Grants.--A funding agreement for a grant 
under subsection (a) is that, subject to section 1916, the 
State involved will expend the grant only for the purpose of--
            (1) carrying out the plan submitted under section 
        1912(a) by the State for the fiscal year involved;
            (2) evaluating programs and services carried out 
        under the plan; and
            (3) planning, administration, and educational 
        activities related to providing services under the 
        plan.

 H4  deg.SEC. 1912. [300X-1] STATE PLAN FOR COMPREHENSIVE 
                    COMMUNITY MENTAL HEALTH SERVICES FOR CERTAIN 
                    INDIVIDUALS.

    (a) In General.--The Secretary may make a grant under 
section 1911 only if--
            (1) the State involved submits to the Secretary a 
        plan for providing comprehensive community mental 
        health services to adults with a serious mental illness 
        and to children with a serious emotional disturbance;
            (2) the plan meets the criteria specified in 
        subsection (b); and
            (3) the plan is approved by the Secretary.
    (b) Criteria for Plan.--With respect to the provision of 
comprehensive community mental health services to individuals 
who are either adults with a serious mental illness or children 
with a serious emotional disturbance, the criteria referred to 
in subsection (a) regarding a plan are as follows:
            (1) Comprehensive community-based mental health 
        systems.--The plan provides for an organized community-
        based system of care for individuals with mental 
        illness and describes available services and resources 
        in a comprehensive system of care, including services 
        for dually diagnosed individuals. The description of 
        the system of care shall include health and mental 
        health services, rehabilitation services, employment 
        services, housing services, educational services, 
        substance abuse services, medical and dental care, and 
        other support services to be provided to individuals 
        with Federal, State and local public and private 
        resources to enable such individuals to function 
        outside of inpatient or residential institutions to the 
        maximum extent of their capabilities, including 
        services to be provided by local school systems under 
        the Individuals with Disabilities Education Act. The 
        plan shall include a separate description of case 
        management services and provide for activities leading 
        to reduction of hospitalization.
            (2) Mental health system data and epidemiology.--
        The plan contains an estimate of the incidence and 
        prevalence in the State of serious mental illness among 
        adults and serious emotional disturbance among children 
        and presents quantitative targets to be achieved in the 
        implementation of the system described in paragraph 
        (1).
            (3) Children's services.--In the case of children 
        with serious emotional disturbance, the plan--
                    (A) subject to subparagraph (B), provides 
                for a system of integrated social services, 
                educational services, juvenile services, and 
                substance abuse services that, together with 
                health and mental health services, will be 
                provided in order for such children to receive 
                care appropriate for their multiple needs (such 
                system to include services provided under the 
                Individuals with Disabilities Education Act);
                    (B) provides that the grant under section 
                1911 for the fiscal year involved will not be 
                expended to provide any service under such 
                system other than comprehensive community 
                mental health services; and
                    (C) provides for the establishment of a 
                defined geographic area for the provision of 
                the services of such system.
            (4) Targeted services to rural and homeless 
        populations.--The plan describes the State's outreach 
        to and services for individuals who are homeless and 
        how community-based services will be provided to 
        individuals residing in rural areas.
            (5) Management systems.--The plan describes the 
        financial resources, staffing and training for mental 
        health providers that is necessary to implement the 
        plan, and provides for the training of providers of 
        emergency health services regarding mental health. The 
        plan further describes the manner in which the State 
        intends to expend the grant under section 1911 for the 
        fiscal year involved.
Except as provided for in paragraph (3), the State plan shall 
contain the information required under this subsection with 
respect to both adults with serious mental illness and children 
with serious emotional disturbance.
    (c) Definitions Regarding Mental Illness and Emotional 
Disturbance; Methods for Estimate of Incidence and 
Prevalence.--
            (1) Establishment by secretary of definitions; 
        dissemination.--For purposes of this subpart, the 
        Secretary shall establish definitions for the terms 
        ``adults with a serious mental illness'' and ``children 
        with a serious emotional disturbance''. The Secretary 
        shall disseminate the definitions to the States.
            (2) Standardized methods.--The Secretary shall 
        establish standardized methods for making the estimates 
        required in subsection (b)(11) with respect to a State. 
        A funding agreement for a grant under section 1911 for 
        the State is that the State will utilize such methods 
        in making the estimates.
            (3) Date certain for compliance by secretary.--Not 
        later than 90 days after the date of the enactment of 
        the ADAMHA Reorganization Act \1\, the Secretary shall 
        establish the definitions described in paragraph (1), 
        shall begin dissemination of the definitions to the 
        States, and shall establish the standardized methods 
        described in paragraph (2).
---------------------------------------------------------------------------
    \1\ Enacted July 10, 1992.
---------------------------------------------------------------------------
    (d) Requirement of Implementation of Plan.--
            (1) Complete implementation.--Except as provided in 
        paragraph (2), in making a grant under section 1911 to 
        a State for a fiscal year, the Secretary shall make a 
        determination of the extent to which the State has 
        implemented the plan required in subsection (a). If the 
        Secretary determines that a State has not completely 
        implemented the plan, the Secretary shall reduce the 
        amount of the allotment under section 1911 for the 
        State for the fiscal year involved by an amount equal 
        to 10 percent of the amount determined under section 
        1918 for the State for the fiscal year.
            (2) Substantial implementation and good faith 
        effort regarding fiscal year 1993.--
                    (A) In making a grant under section 1911 to 
                a State for fiscal year 1993, the Secretary 
                shall make a determination of the extent to 
                which the State has implemented the plan 
                required in subsection (a). If the Secretary 
                determines that the State has not substantially 
                implemented the plan, the Secretary shall, 
                subject to subparagraph (B), reduce the amount 
                of the allotment under section 1911 for the 
                State for such fiscal year by an amount equal 
                to 10 percent of the amount determined under 
                section 1918 for the State for the fiscal year.
                    (B) In carrying out subparagraph (A), if 
                the Secretary determines that the State is 
                making a good faith effort to implement the 
                plan required in subsection (a), the Secretary 
                may make a reduction under such subparagraph in 
                an amount that is less than the amount 
                specified in such subparagraph, except that the 
                reduction may not be made in an amount that is 
                less than 5 percent of the amount determined 
                under section 1918 for the State for fiscal 
                year 1993.

SEC. 1913. [300X-2] CERTAIN AGREEMENTS.

    (a) Allocation for Systems of Integrated Services for 
Children.--
            (1) In general.--With respect to children with a 
        serious emotional disturbance, a funding agreement for 
        a grant under section 1911 is that--
                    (A) in the case of a grant for fiscal year 
                1993, the State involved will expend not less 
                than 10 percent of the grant to increase 
                (relative to fiscal year 1992) funding for the 
                system of integrated services described in 
                section 1912(b)(9);
                    (B) in the case of a grant for fiscal year 
                1994, the State will expend not less than 10 
                percent of the grant to increase (relative to 
                fiscal year 1993) funding for such system; and
                    (C) in the case of a grant for any 
                subsequent fiscal year, the State will expend 
                for such system not less than an amount equal 
                to the amount expended by the State for fiscal 
                year 1994.
            (2) Waiver.--
                    (A) Upon the request of a State, the 
                Secretary may provide to the State a waiver of 
                all or part of the requirement established in 
                paragraph (1) if the Secretary determines that 
                the State is providing an adequate level of 
                comprehensive community mental health services 
                for children with a serious emotional 
                distrubance \1\, as indicated by a comparison 
                of the number of such children for which such 
                services are sought with the availability in 
                the State of the services.
---------------------------------------------------------------------------
    \1\ So in law. See section 201 of Public Law 102-321 (106 Stat. 
381). Probably should be ``disturbance''.
---------------------------------------------------------------------------
                    (B) The Secretary shall approve or deny a 
                request for a waiver under subparagraph (A) not 
                later than 120 days after the date on which the 
                request is made.
                    (C) Any waiver provided by the Secretary 
                under subparagraph (A) shall be applicable only 
                to the fiscal year involved.
    (b) Providers of Services.--A funding agreement for a grant 
under section 1911 for a State is that, with respect to the 
plan submitted under section 1912(a) for the fiscal year 
involved--
            (1) services under the plan will be provided only 
        through appropriate, qualified community programs 
        (which may include community mental health centers, 
        child mental-health programs, psychosocial 
        rehabilitation programs, mental health peer-support 
        programs, and mental-health primary consumer-directed 
        programs); and
            (2) services under the plan will be provided 
        through community mental health centers only if the 
        centers meet the criteria specified in subsection (c).
    (c) Criteria for Mental Health Centers.--The criteria 
referred to in subsection (b)(2) regarding community mental 
health centers are as follows:
            (1) With respect to mental health services, the 
        centers provide services as follows:
                    (A) Services principally to individuals 
                residing in a defined geographic area 
                (hereafter in this subsection referred to as a 
                ``service area'').
                    (B) Outpatient services, including 
                specialized outpatient services for children, 
                the elderly, individuals with a serious mental 
                illness, and residents of the service areas of 
                the centers who have been discharged from 
                inpatient treatment at a mental health 
                facility.
                    (C) 24-hour-a-day emergency care services.
                    (D) Day treatment or other partial 
                hospitalization services, or psychosocial 
                rehabilitation services.
                    (E) Screening for patients being considered 
                for admission to State mental health facilities 
                to determine the appropriateness of such 
                admission.
            (2) The mental health services of the centers are 
        provided, within the limits of the capacities of the 
        centers, to any individual residing or employed in the 
        service area of the center regardless of ability to pay 
        for such services.
            (3) The mental health services of the centers are 
        available and accessible promptly, as appropriate and 
        in a manner which preserves human dignity and assures 
        continuity and high quality care.

 H4  deg.SEC. 1914. [300X-3] STATE MENTAL HEALTH PLANNING 
                    COUNCIL.

    (a) In General.--A funding agreement for a grant under 
section 1911 is that the State involved will establish and 
maintain a State mental health planning council in accordance 
with the conditions described in this section.
    (b) Duties.--A condition under subsection (a) for a Council 
is that the duties of the Council are--
            (1) to review plans provided to the Council 
        pursuant to section 1915(a) by the State involved and 
        to submit to the State any recommendations of the 
        Council for modifications to the plans;
            (2) to serve as an advocate for adults with a 
        serious mental illness, children with a severe 
        emotional disturbance, and other individuals with 
        mental illnesses or emotional problems; and
            (3) to monitor, review, and evaluate, not less than 
        once each year, the allocation and adequacy of mental 
        health services within the State.
    (c) Membership.--
            (1) In general.--A condition under subsection (a) 
        for a Council is that the Council be composed of 
        residents of the State, including representatives of--
                    (A) the principal State agencies with 
                respect to--
                            (i) mental health, education, 
                        vocational rehabilitation, criminal 
                        justice, housing, and social services; 
                        and
                            (ii) the development of the plan 
                        submitted pursuant to title XIX of the 
                        Social Security Act;
                    (B) public and private entities concerned 
                with the need, planning, operation, funding, 
                and use of mental health services and related 
                support services;
                    (C) adults with serious mental illnesses 
                who are receiving (or have received) mental 
                health services; and
                    (D) the families of such adults or families 
                of children with emotional disturbance.
            (2) Certain requirements.--A condition under 
        subsection (a) for a Council is that--
                    (A) with respect to the membership of the 
                Council, the ratio of parents of children with 
                a serious emotional disturbance to other 
                members of the Council is sufficient to provide 
                adequate representation of such children in the 
                deliberations of the Council; and
                    (B) not less than 50 percent of the members 
                of the Council are individuals who are not 
                State employees or providers of mental health 
                services.
    (d) Definition.--For purposes of this section, the term 
``Council'' means a State mental health planning council.

SEC. 1915. [300X-4] ADDITIONAL PROVISIONS.

    (a) Review of State Plan by Mental Health Planning 
Council.--The Secretary may make a grant under section 1911 to 
a State only if--
            (1) the plan submitted under section 1912(a) with 
        respect to the grant and the report of the State under 
        section 1942(a) concerning the preceding fiscal year 
        has been reviewed by the State mental health planning 
        council under section 1914; and
            (2) the State submits to the Secretary any 
        recommendations received by the State from such council 
        for modifications to the plan (without regard to 
        whether the State has made the recommended 
        modifications) and any comments concerning the annual 
        report.
    (b) Maintenance of Effort Regarding State Expenditures for 
Mental Health.--
            (1) In general.--A funding agreement for a grant 
        under section 1911 is that the State involved will 
        maintain State expenditures for community mental health 
        services at a level that is not less than the average 
        level of such expenditures maintained by the State for 
        the 2-year period preceding the fiscal year for which 
        the State is applying for the grant.
            (2) Exclusion of certain funds.--The Secretary may 
        exclude from the aggregate State expenditures under 
        subsection (a), funds appropriated to the principle 
        agency for authorized activities which are of a non-
        recurring nature and for a specific purpose.
            (3) Waiver.--The Secretary may, upon the request of 
        a State, waive the requirement established in paragraph 
        (1) if the Secretary determines that extraordinary 
        economic conditions in the State justify the waiver.
            (4) Noncompliance by State.--
                    (A) In making a grant under section 1911 to 
                a State for a fiscal year, the Secretary shall 
                make a determination of whether, for the 
                previous fiscal year, the State maintained 
                material compliance with the agreement made 
                under paragraph (1). If the Secretary 
                determines that a State has failed to maintain 
                such compliance, the Secretary shall reduce the 
                amount of the allotment under section 1911 for 
                the State for the fiscal year for which the 
                grant is being made by an amount equal to the 
                amount constituting such failure for the 
                previous fiscal year.
                    (B) The Secretary may make a grant under 
                section 1911 for a fiscal year only if the 
                State involved submits to the Secretary 
                information sufficient for the Secretary to 
                make the determination required in subparagraph 
                (A).

SEC. 1916. [300X-5] RESTRICTIONS ON USE OF PAYMENTS.

    (a) In General.--A funding agreement for a grant under 
section 1911 is that the State involved will not expend the 
grant--
            (1) to provide inpatient services;
            (2) to make cash payments to intended recipients of 
        health services;
            (3) to purchase or improve land, purchase, 
        construct, or permanently improve (other than minor 
        remodeling) any building or other facility, or purchase 
        major medical equipment;
            (4) to satisfy any requirement for the expenditure 
        of non-Federal funds as a condition for the receipt of 
        Federal funds; or
            (5) to provide financial assistance to any entity 
        other than a public or nonprofit private entity.
    (b) Limitation on Administrative Expenses.--A funding 
agreement for a grant under section 1911 is that the State 
involved will not expend more than 5 percent of the grant for 
administrative expenses with respect to the grant.

 H4  deg.SEC. 1917. [300X-6] APPLICATION FOR GRANT.

    (a) In General.--For purposes of section 1911, an 
application for a grant under such section for a fiscal year in 
accordance with \1\ this section if, subject to subsection 
(b)--
---------------------------------------------------------------------------
    \1\ So in law. See section 201 of Public Law 102-321 (106 Stat. 
384). Probably should be ``is in accordance with''.
---------------------------------------------------------------------------
            (1) the plan is received by the Secretary not later 
        than September 1 of the fiscal year prior to the fiscal 
        year for which a State is seeking funds, and the report 
        from the previous fiscal year as required under section 
        1941 is received by December 1 of the fiscal year of 
        the grant;
            (2) the application contains each funding agreement 
        that is described in this subpart or subpart III for 
        such a grant (other than any such agreement that is not 
        applicable to the State);
            (3) the agreements are made through certification 
        from the chief executive officer of the State;
            (4) with respect to such agreements, the 
        application provides assurances of compliance 
        satisfactory to the Secretary;
            (5) the application contains the plan required in 
        section 1912(a), the information required in section 
        1915(b)(3)(B), and the report required in section 
        1942(a);
            (6) the application contains recommendations in 
        compliance with section 1915(a), or if no such 
        recommendations are received by the State, the 
        application otherwise demonstrates compliance with such 
        section; and
            (7) the application (including the plan under 
        section 1912(a)) is otherwise in such form, is made in 
        such manner, and contains such agreements, assurances, 
        and information as the Secretary determines to be 
        necessary to carry out this subpart.
    (b) Waivers Regarding Certain Territories.--In the case of 
any territory of the United States except Puerto Rico, the 
Secretary may waive such provisions of this subpart and subpart 
III as the Secretary determines to be appropriate, other than 
the provisions of section 1916.

SEC. 1918. [300X-7] DETERMINATION OF AMOUNT OF ALLOTMENT.

    (a) States.--
            (1) Determination under formula.--Subject to 
        subsection (b), the Secretary shall determine the 
        amount of the allotment required in section 1911 for a 
        State for a fiscal year in accordance with the 
        following formula:

      

 
                                                                 X
                                                   A  <3-ln (> ---- <3-ln )>
                                                                 U
----------------------------------------------------------------------------------------------------------------
 

            (2) Determination of term ``a''.--For purposes of 
        paragraph (1), the term ``A'' means the difference 
        between--
                    (A) the amount appropriated under section 
                1920(a) for allotments under section 1911 for 
                the fiscal year involved; and
                    (B) an amount equal to 1.5 percent of the 
                amount referred to in subparagraph (A).
            (3) Determination of term ``u''.--For purposes of 
        paragraph (1), the term ``U'' means the sum of the 
        respective terms ``X'' determined for the States under 
        paragraph (4).
            (4) Determination of term ``x''.--For purposes of 
        paragraph (1), the term ``X'' means the product of--
                    (A) an amount equal to the product of--
                            (i) the term ``P'', as determined 
                        for the State involved under paragraph 
                        (5); and
                            (ii) the factor determined under 
                        paragraph (8) for the State; and
                    (B) the greater of--
                            (i) 0.4; and
                            (ii) an amount equal to an amount 
                        determined for the State in accordance 
                        with the following formula:

      

 
                                                                   R%
                                               1-.35   <3-ln (> ------- <3-ln )>
                                                                   P%
----------------------------------------------------------------------------------------------------------------
 

            (5) Determination of term ``p''.--
                    (A) For purposes of paragraph (4), the term 
                ``P'' means the sum of--
                            (i) an amount equal to the product 
                        of 0.107 and the number of individuals 
                        in the State who are between 18 and 24 
                        years of age (inclusive);
                            (ii) an amount equal to the product 
                        of 0.166 and the number of individuals 
                        in the State who are between 25 and 44 
                        years of age (inclusive);
                            (iii) an amount equal to the 
                        product of 0.099 and the number of 
                        individuals in the State who are 
                        between 45 and 64 years of age 
                        (inclusive); and
                            (iv) an amount equal to the product 
                        of 0.082 and the number of individuals 
                        in the State who are 65 years of age or 
                        older.
                    (B) With respect to data on population that 
                is necessary for purposes of making a 
                determination under subparagraph (A), the 
                Secretary shall use the most recent data that 
                is available from the Secretary of Commerce 
                pursuant to the decennial census and pursuant 
                to reasonable estimates by such Secretary of 
                changes occurring in the data in the ensuing 
                period.
            (6) Determination of term ``r%''.--
                    (A) For purposes of paragraph (4), the term 
                ``R%'', except as provided in subparagraph (D), 
                means the percentage constituted by the ratio 
                of the amount determined under subparagraph (B) 
                for the State involved to the amount determined 
                under subparagraph (C).
                    (B) The amount determined under this 
                subparagraph for the State involved is the 
                quotient of--
                            (i) the most recent 3-year 
                        arithmetic mean of the total taxable 
                        resources of the State, as determined 
                        by the Secretary of the Treasury; 
                        divided by
                            (ii) the factor determined under 
                        paragraph (8) for the State.
                    (C) The amount determined under this 
                subparagraph is the sum of the respective 
                amounts determined for the States under 
                subparagraph (B) (including the District of 
                Columbia).
                    (D)(i) In the case of the District of 
                Columbia, for purposes of paragraph (4), the 
                term ``R%'' means the percentage constituted by 
                the ratio of the amount determined under clause 
                (ii) for such District to the amount determined 
                under clause (iii).
                    (ii) The amount determined under this 
                clause for the District of Columbia is the 
                quotient of--
                            (I) the most recent 3-year 
                        arithmetic mean of total personal 
                        income in such District, as determined 
                        by the Secretary of Commerce; divided 
                        by
                            (II) the factor determined under 
                        paragraph (8) for the District.
                    (iii) The amount determined under this 
                clause is the sum of the respective amounts 
                determined for the States (including the 
                District of Columbia) by making, for each 
                State, the same determination as is described 
                in clause (ii) for the District of Columbia.
            (7) Determination of term ``p%''.--For purposes of 
        paragraph (4), the term ``P%'' means the percentage 
        constituted by the ratio of the term ``P'' determined 
        under paragraph (5) for the State involved to the sum 
        of the respective terms ``P'' determined for the 
        States.
            (8) Determination of certain factor.--
                    (A) The factor determined under this 
                paragraph for the State involved is a factor 
                whose purpose is to adjust the amount 
                determined under clause (i) of paragraph 
                (4)(A), and the amounts determined under each 
                of subparagraphs (B)(i) and (D)(ii)(I) of 
                paragraph (6), to reflect the differences that 
                exist between the State and other States in the 
                costs of providing comprehensive community 
                mental health services to adults with a serious 
                mental illness and to children with a serious 
                emotional disturbance.
                    (B) Subject to subparagraph (C), the factor 
                determined under this paragraph and in effect 
                for the fiscal year involved shall be 
                determined according to the methodology 
                described in the report entitled ``Adjusting 
                the Alcohol, Drug Abuse and Mental Health 
                Services Block Grant Allocations for Poverty 
                Populations and Cost of Service'', dated March 
                30, 1990, and prepared by Health Economics 
                Research, a corporation, pursuant to a contract 
                with the National Institute on Drug Abuse.
                    (C) The factor determined under this 
                paragraph for the State involved may not for 
                any fiscal year be greater than 1.1 or less 
                than 0.9.
                    (D)(i) Not later than October 1, 1992, the 
                Secretary, after consultation with the 
                Comptroller General, shall in accordance with 
                this section make a determination for each 
                State of the factor that is to be in effect for 
                the State under this paragraph. The factor so 
                determined shall remain in effect through 
                fiscal year 1994, and shall be recalculated 
                every third fiscal year thereafter.
                    (ii) After consultation with the 
                Comptroller General, the Secretary shall, 
                through publication in the Federal Register, 
                periodically make such refinements in the 
                methodology referred to in subparagraph (B) as 
                are consistent with the purpose described in 
                subparagraph (A).
    (b) Minimum Allotments for States.--With respect to fiscal 
year 2000, and subsequent fiscal years, the amount of the 
allotment of a State under section 1911 shall not be less than 
the amount the State received under such section for fiscal 
year 1998.
    (c) Territories.--
            (1) Determination under formula.--Subject to 
        paragraphs (2) and (4), the amount of an allotment 
        under section 1911 for a territory of the United States 
        for a fiscal year shall be the product of--
                    (A) an amount equal to the amounts reserved 
                under paragraph (3) for the fiscal year; and
                    (B) a percentage equal to the quotient of--
                            (i) the civilian population of the 
                        territory, as indicated by the most 
                        recently available data; divided by
                            (ii) the aggregate civilian 
                        population of the territories of the 
                        United States, as indicated by such 
                        data.
            (2) Minimum allotment for territories.--The amount 
        of an allotment under section 1911 for a territory of 
        the United States for a fiscal year shall be the 
        greater of--
                    (A) the amount determined under paragraph 
                (1) for the territory for the fiscal year;
                    (B) $50,000; and
                    (C) with respect to fiscal years 1993 and 
                1994, an amount equal to 20.6 percent of the 
                amount received by the territory from 
                allotments made pursuant to this part for 
                fiscal year 1992.
            (3) Reservation of amounts.--The Secretary shall 
        each fiscal year reserve for the territories of the 
        United States 1.5 percent of the amounts appropriated 
        under section 1920(a) for allotments under section 1911 
        for the fiscal year.
            (4) Availability of data on population.--With 
        respect to data on the civilian population of the 
        territories of the United States, if the Secretary 
        determines for a fiscal year that recent such data for 
        purposes of paragraph (1)(B) do not exist regarding a 
        territory, the Secretary shall for such purposes 
        estimate the civilian population of the territory by 
        modifying the data on the territory to reflect the 
        average extent of change occurring during the ensuing 
        period in the population of all territories with 
        respect to which recent such data do exist.
            (5) Applicability of certain provisions.--For 
        purposes of subsection (a), the term ``State'' does not 
        include the territories of the United States.

SEC. 1919. [300X-8] DEFINITIONS.

    For purposes of this subpart:
            (1) The terms ``adults with a serious mental 
        illness'' and ``children with a serious emotional 
        disturbance'' have the meanings given such terms under 
        section 1912(c)(1).
            (2) The term ``funding agreement'', with respect to 
        a grant under section 1911 to a State, means that the 
        Secretary may make such a grant only if the State makes 
        the agreement involved.

 H4  deg.SEC. 1920. [300X-9] FUNDING.

    (a) Authorization of Appropriations.--For the purpose of 
carrying out this subpart, and subpart III and section 505 with 
respect to mental health, there are authorized to be 
appropriated $450,000,000 for fiscal year 2001, and such sums 
as may be necessary for each of the fiscal years 2002 and 2003.
    (b) Allocations for Technical Assistance, Data Collection, 
and Program Evaluation.--
            (1) In general.--For the purpose of carrying out 
        section 1948(a) with respect to mental health and the 
        purposes specified in paragraphs (2) and (3), the 
        Secretary shall obligate 5 percent of the amounts 
        appropriated under subsection (a) for a fiscal year.
            (2) Data collection.--The purpose specified in this 
        paragraph is carrying out sections 505 and 1971 with 
        respect to mental health.
            (3) Program evaluation.--The purpose specified in 
        this paragraph is the conduct of evaluations of 
        prevention and treatment programs and services with 
        respect to mental health to determine methods for 
        improving the availability and quality of such programs 
        and services.

  Subpart II--Block Grants for Prevention and Treatment of Substance 
                                 Abuse

 H4  deg.SEC. 1921. [300X-21] FORMULA GRANTS TO STATES.

    (a) In General.--For the purpose described in subsection 
(b), the Secretary, acting through the Center for Substance 
Abuse Treatment, shall make an allotment each fiscal year for 
each State in an amount determined in accordance with section 
1933. The Secretary shall make a grant to the State of the 
allotment made for the State for the fiscal year if the State 
submits to the Secretary an application in accordance with 
section 1932.
    (b) Authorized Activities.--A funding agreement for a grant 
under subsection (a) is that, subject to section 1931, the 
State involved will expend the grant only for the purpose of 
planning, carrying out, and evaluating activities to prevent 
and treat substance abuse and for related activities authorized 
in section 1924.

 H4  deg.SEC. 1922. [300X-22] CERTAIN ALLOCATIONS.

    (a) Allocation Regarding Primary Prevention Programs.--A 
funding agreement for a grant under section 1921 is that, in 
expending the grant, the State involved--
            (1) will expend not less than 20 percent for 
        programs for individuals who do not require treatment 
        for substance abuse, which programs--
                    (A) educate and counsel the individuals on 
                such abuse; and
                    (B) provide for activities to reduce the 
                risk of such abuse by the individuals;
            (2) will, in carrying out paragraph (1)--
                    (A) give priority to programs for 
                populations that are at risk of developing a 
                pattern of such abuse; and
                    (B) ensure that programs receiving priority 
                under subparagraph (A) develop community-based 
                strategies for the prevention of such abuse, 
                including strategies to discourage the use of 
                alcoholic beverages and tobacco products by 
                individuals to whom it is unlawful to sell or 
                distribute such beverages or products.
    (b) \1\ Allocations Regarding Women.--
---------------------------------------------------------------------------
    \1\ Paragraph (2)(A) of section 3303(f) of Public Law 106-310 (114 
Stat. 1211) provides as follows:

          (2) Conforming amendments.--Effective upon the publication of 
        the regulations developed in accordance with section 1932(e)(1) 
        of the Public Health Service Act (42 U.S.C. 300x-32(d))--

                  (A) section 1922(c) of the Public Health Service Act 
                (42 U.S.C. 300x-22(c)) is amended by--
                          (i) striking paragraph (2); and
                          (ii) redesignating paragraph (3) as paragraph 
                        (2); and

    The reference to section 1922(c) probably should be a reference to 
section 1922(b), as amended by section 3303(a) of such Public Law.
---------------------------------------------------------------------------
            (1) In general.--Subject to paragraph (2), a 
        funding agreement for a grant under section 1921 for a 
        fiscal year is that--
                    (A) in the case of a grant for fiscal year 
                1993, the State involved will expend not less 
                than 5 percent of the grant to increase 
                (relative to fiscal year 1992) the availability 
                of treatment services designed for pregnant 
                women and women with dependent children (either 
                by establishing new programs or expanding the 
                capacity of existing programs);
                    (B) in the case of a grant for fiscal year 
                1994, the State will expend not less than 5 
                percent of the grant to so increase (relative 
                to fiscal year 1993) the availability of such 
                services for such women; and
                    (C) in the case of a grant for any 
                subsequent fiscal year, the State will expend 
                for such services for such women not less than 
                an amount equal to the amount expended by the 
                State for fiscal year 1994.
            (2) Waiver.--
                    (A) Upon the request of a State, the 
                Secretary may provide to the State a waiver of 
                all or part of the requirement established in 
                paragraph (1) if the Secretary determines that 
                the State is providing an adequate level of 
                treatments services for women described in such 
                paragraph, as indicated by a comparison of the 
                number of such women seeking the services with 
                the availability in the State of the services.
                    (B) The Secretary shall approve or deny a 
                request for a waiver under subparagraph (A) not 
                later than 120 days after the date on which the 
                request is made.
                    (C) Any waiver provided by the Secretary 
                under subparagraph (A) shall be applicable only 
                to the fiscal year involved.
            (3) Childcare and prenatal care.--A funding 
        agreement for a grant under section 1921 for a State is 
        that each entity providing treatment services with 
        amounts reserved under paragraph (1) by the State will, 
        directly or through arrangements with other public or 
        nonprofit private entities, make available prenatal 
        care to women receiving such services and, while the 
        women are receiving the services, childcare.

 H4  deg.SEC. 1923. [300X-23] INTRAVENOUS SUBSTANCE ABUSE.

    (a) Capacity of Treatment Programs.--
            (1) Notification of reaching capacity.--A funding 
        agreement for a grant under section 1921 is that the 
        State involved will, in the case of programs of 
        treatment for intravenous drug abuse, require that any 
        such program receiving amounts from the grant, upon 
        reaching 90 percent of its capacity to admit 
        individuals to the program, provide to the State a 
        notification of such fact.
            (2) Provision of treatment.--A funding agreement 
        for a grant under section 1921 is that the State 
        involved will, with respect to notifications under 
        paragraph (1), ensure that each individual who requests 
        and is in need of treatment for intravenous drug abuse 
        is admitted to a program of such treatment not later 
        than--
                    (A) 14 days after making the request for 
                admission to such a program; or
                    (B) 120 days after the date of such 
                request, if no such program has the capacity to 
                admit the individual on the date of such 
                request and if interim services are made 
                available to the individual not later than 48 
                hours after such request.
    (b) Outreach Regarding Intravenous Substance Abuse.--A 
funding agreement for a grant under section 1921 is that the 
State involved, in providing amounts from the grant to any 
entity for treatment services for intravenous drug abuse, will 
require the entity to carry out activities to encourage 
individuals in need of such treatment to undergo treatment.

SEC. 1924. [300X-24] REQUIREMENTS REGARDING TUBERCULOSIS AND HUMAN 
                    IMMUNODEFICIENCY VIRUS.

    (a) Tuberculosis.--
            (1) In general.--A funding agreement for a grant 
        under section 1921 is that the State involved will 
        require that any entity receiving amounts from the 
        grant for operating a program of treatment for 
        substance abuse--
                    (A) will, directly or through arrangements 
                with other public or nonprofit private 
                entities, routinely make available tuberculosis 
                services to each individual receiving treatment 
                for such abuse; and
                    (B) in the case of an individual in need of 
                such treatment who is denied admission to the 
                program on the basis of the lack of the 
                capacity of the program to admit the 
                individual, will refer the individual to 
                another provider of tuberculosis services.
            (2) Tuberculosis services.--For purposes of 
        paragraph (1), the term ``tuberculosis services'', with 
        respect to an individual, means--
                    (A) counseling the individual with respect 
                to tuberculosis;
                    (B) testing to determine whether the 
                individual has contracted such disease and 
                testing to determine the form of treatment for 
                the disease that is appropriate for the 
                individual; and
                    (C) providing such treatment to the 
                individual.
    (b) Human Immunodeficiency Virus.--
            (1) Requirement for certain states.--In the case of 
        a State described in paragraph (2), a funding agreement 
        for a grant under section 1921 is that--
                    (A) with respect to individuals undergoing 
                treatment for substance abuse, the State will, 
                subject to paragraph (3), carry out 1 or more 
                projects to make available to the individuals 
                early intervention services for HIV disease at 
                the sites at which the individuals are 
                undergoing such treatment;
                    (B) for the purpose of providing such early 
                intervention services through such projects, 
                the State will make available from the grant 
                the percentage that is applicable for the State 
                under paragraph (4); and
                    (C) the State will, subject to paragraph 
                (5), carry out such projects only in geographic 
                areas of the State that have the greatest need 
                for the projects.
            (2) Designated states.--For purposes of this 
        subsection, a State described in this paragraph is any 
        State whose rate of cases of acquired immune deficiency 
        syndrome is 10 or more such cases per 100,000 
        individuals (as indicated by the number of such cases 
        reported to and confirmed by the Director of the 
        Centers for Disease Control for the most recent 
        calendar year for which such data are available).
            (3) Use of existing programs regarding substance 
        abuse.--With respect to programs that provide treatment 
        services for substance abuse, a funding agreement for a 
        grant under section 1921 for a designated State is that 
        each such program participating in a project under 
        paragraph (1) will be a program that began operation 
        prior to the fiscal year for which the State is 
        applying to receive the grant. A program that so began 
        operation may participate in a project under paragraph 
        (1) without regard to whether the program has been 
        providing early intervention services for HIV disease.
            (4) Applicable percentage regarding expenditures 
        for services.--
                    (A)(i) For purposes of paragraph (1)(B), 
                the percentage that is applicable under this 
                paragraph for a designated State is, subject to 
                subparagraph (B), the percentage by which the 
                amount of the grant under section 1921 for the 
                State for the fiscal year involved is an 
                increase over the amount specified in clause 
                (ii).
                    (ii) The amount specified in this clause is 
                the amount that was reserved by the designated 
                State involved from the allotment of the State 
                under section 1912A for fiscal year 1991 in 
                compliance with section 1916(c)(6)(A)(ii) (as 
                such sections were in effect for such fiscal 
                year).
                    (B) If the percentage determined under 
                subparagraph (A) for a designated State for a 
                fiscal year is less than 2 percent (including a 
                negative percentage, in the case of a State for 
                which there is no increase for purposes of such 
                subparagraph), the percentage applicable under 
                this paragraph for the State is 2 percent. If 
                the percentage so determined is 2 percent or 
                more, the percentage applicable under this 
                paragraph for the State is the percentage 
                determined under subparagraph (A), subject to 
                not exceeding 5 percent.
            (5) Requirement regarding rural areas.--
                    (A) A funding agreement for a grant under 
                section 1921 for a designated State is that, if 
                the State will carry out 2 or more projects 
                under paragraph (1), the State will carry out 1 
                such project in a rural area of the State, 
                subject to subparagraph (B).
                    (B) The Secretary shall waive the 
                requirement established in subparagraph (A) if 
                the State involved certifies to the Secretary 
                that--
                            (i) there is insufficient demand in 
                        the State to carry out a project under 
                        paragraph (1) in any rural area of the 
                        State; or
                            (ii) there are no rural areas in 
                        the State.
            (6) Manner of providing services.--With respect to 
        the provision of early intervention services for HIV 
        disease to an individual, a funding agreement for a 
        grant under section 1921 for a designated State is 
        that--
                    (A) such services will be undertaken 
                voluntarily by, and with the informed consent 
                of, the individual; and
                    (B) undergoing such services will not be 
                required as a condition of receiving treatment 
                services for substance abuse or any other 
                services.
            (7) Definitions.--For purposes of this subsection:
                    (A) The term ``designated State'' means a 
                State described in paragraph (2).
                    (B) The term ``early intervention 
                services'', with respect to HIV disease, 
                means--
                            (i) appropriate pretest counseling;
                            (ii) testing individuals with 
                        respect to such disease, including 
                        tests to confirm the presence of the 
                        disease, tests to diagnose the extent 
                        of the deficiency in the immune system, 
                        and tests to provide information on 
                        appropriate therapeutic measures for 
                        preventing and treating the 
                        deterioration of the immune system and 
                        for preventing and treating conditions 
                        arising from the disease;
                            (iii) appropriate post-test 
                        counseling; and
                            (iv) providing the therapeutic 
                        measures described in clause (ii).
                    (C) The term ``HIV disease'' means 
                infection with the etiologic agent for acquired 
                immune deficiency syndrome.
    (c) Expenditure of Grant for Compliance With Agreements.--
            (1) In general.--A grant under section 1921 may be 
        expended for purposes of compliance with the agreements 
        required in this section, subject to paragraph (2).
            (2) Limitation.--A funding agreement for a grant 
        under section 1921 for a State is that the grant will 
        not be expended to make payment for any service 
        provided for purposes of compliance with this section 
        to the extent that payment has been made, or can 
        reasonably be expected to be made, with respect to such 
        service--
                    (A) under any State compensation program, 
                under any insurance policy, or under any 
                Federal or State health benefits program 
                (including the program established in title 
                XVIII of the Social Security Act and the 
                program established in title XIX of such Act); 
                or
                    (B) by an entity that provides health 
                services on a prepaid basis.
    (d) Maintenance of Effort.--With respect to services 
provided for by a State for purposes of compliance with this 
section, a funding agreement for a grant under section 1921 is 
that the State will maintain expenditures of non-Federal 
amounts for such services at a level that is not less than 
average level of such expenditures maintained by the State for 
2-year period preceding the first fiscal year for which the 
State receives such a grant.
    (e) Applicability of Certain Provision.--Section 1931 
applies to this section (and to each other provision of this 
subpart).

 H4  deg.SEC. 1925. [300X-25] GROUP HOMES FOR RECOVERING 
                    SUBSTANCE ABUSERS.

    (a) State Revolving Funds for Establishment of Homes.--A 
State, using funds available under section 1921, may establish 
and maintain the ongoing operation of a revolving fund in 
accordance with this section to support group homes for 
recovering substance abusers as follows:
            (1) The purpose of the fund is to make loans for 
        the costs of establishing programs for the provision of 
        housing in which individuals recovering from alcohol or 
        drug abuse may reside in groups of not less than 6 
        individuals. The fund is established directly by the 
        State or through the provision of a grant or contract 
        to a nonprofit private entity.
            (2) The programs are carried out in accordance with 
        guidelines issued under subsection (b).
            (3) Not less than $100,000 is available for the 
        fund.
            (4) Loans made from the revolving fund do not 
        exceed $4,000 and each such loan is repaid to the 
        revolving fund by the residents of the housing involved 
        not later than 2 years after the date on which the loan 
        is made.
            (5) Each such loan is repaid by such residents 
        through monthly installments, and a reasonable penalty 
        is assessed for each failure to pay such periodic 
        installments by the date specified in the loan 
        agreement involved.
            (6) Such loans are made only to nonprofit private 
        entities agreeing that, in the operation of the program 
        established pursuant to the loan--
                    (A) the use of alcohol or any illegal drug 
                in the housing provided by the program will be 
                prohibited;
                    (B) any resident of the housing who 
                violates such prohibition will be expelled from 
                the housing;
                    (C) the costs of the housing, including 
                fees for rent and utilities, will be paid by 
                the residents of the housing; and
                    (D) the residents of the housing will, 
                through a majority vote of the residents, 
                otherwise establish policies governing 
                residence in the housing, including the manner 
                in which applications for residence in the 
                housing are approved.
    (b) Issuance by Secretary of Guidelines.--The Secretary 
shall ensure that there are in effect guidelines under this 
subpart for the operation of programs described in subsection 
(a).
    (c) Applicability to Territories.--The requirements 
established in subsection (a) shall not apply to any territory 
of the United States other than the Commonwealth of Puerto 
Rico.

 H4  deg.SEC. 1926. [300X-26] STATE LAW REGARDING SALE OF 
                    TOBACCO PRODUCTS TO INDIVIDUALS UNDER AGE OF 18.

    (a) Relevant Law.--
            (1) In general.--Subject to paragraph (2), for 
        fiscal year 1994 and subsequent fiscal years, the 
        Secretary may make a grant under section 1921 only if 
        the State involved has in effect a law providing that 
        it is unlawful for any manufacturer, retailer, or 
        distributor of tobacco products to sell or distribute 
        any such product to any individual under the age of 18.
            (2) Delayed applicability for certain states.--In 
        the case of a State whose legislature does not convene 
        a regular session in fiscal year 1993, and in the case 
        of a State whose legislature does not convene a regular 
        session in fiscal year 1994, the requirement described 
        in paragraph (1) as a condition of a receipt of a grant 
        under section 1921 shall apply only for fiscal year 
        1995 and subsequent fiscal years.
    (b) Enforcement.--
            (1) In general.--For the first applicable fiscal 
        year and for subsequent fiscal years, a funding 
        agreement for a grant under section 1921 is that the 
        State involved will enforce the law described in 
        subsection (a) in a manner that can reasonably be 
        expected to reduce the extent to which tobacco products 
        are available to individuals under the age of 18.
            (2) Activities and reports regarding enforcement.--
        For the first applicable fiscal year and for subsequent 
        fiscal years, a funding agreement for a grant under 
        section 1921 is that the State involved will--
                    (A) annually conduct random, unannounced 
                inspections to ensure compliance with the law 
                described in subsection (a); and
                    (B) annually submit to the Secretary a 
                report describing--
                            (i) the activities carried out by 
                        the State to enforce such law during 
                        the fiscal year preceding the fiscal 
                        year for which the State is seeking the 
                        grant;
                            (ii) the extent of success the 
                        State has achieved in reducing the 
                        availability of tobacco products to 
                        individuals under the age of 18; and
                            (iii) the strategies to be utilized 
                        by the State for enforcing such law 
                        during the fiscal year for which the 
                        grant is sought.
    (c) Noncompliance of State.--Before making a grant under 
section 1921 to a State for the first applicable fiscal year or 
any subsequent fiscal year, the Secretary shall make a 
determination of whether the State has maintained compliance 
with subsections (a) and (b). If, after notice to the State and 
an opportunity for a hearing, the Secretary determines that the 
State is not in compliance with such subsections, the Secretary 
shall reduce the amount of the allotment under such section for 
the State for the fiscal year involved by an amount equal to--
            (1) in the case of the first applicable fiscal 
        year, 10 percent of the amount determined under section 
        1933 for the State for the fiscal year;
            (2) in the case of the first fiscal year following 
        such applicable fiscal year, 20 percent of the amount 
        determined under section 1933 for the State for the 
        fiscal year;
            (3) in the case of the second such fiscal year, 30 
        percent of the amount determined under section 1933 for 
        the State for the fiscal year; and
            (4) in the case of the third such fiscal year or 
        any subsequent fiscal year, 40 percent of the amount 
        determined under section 1933 for the State for the 
        fiscal year.
    (d) Definition.--For purposes of this section, the term 
``first applicable fiscal year'' means--
            (1) fiscal year 1995, in the case of any State 
        described in subsection (a)(2); and
            (2) fiscal year 1994, in the case of any other 
        State.

 H4  deg.SEC. 1927. [300X-27] TREATMENT SERVICES FOR PREGNANT 
                    WOMEN.

    (a) In General.--A funding agreement for a grant under 
section 1921 is that the State involved--
            (1) will ensure that each pregnant woman in the 
        State who seeks or is referred for and would benefit 
        from such services is given preference in admissions to 
        treatment facilities receiving funds pursuant to the 
        grant; and
            (2) will, in carrying out paragraph (1), publicize 
        the availability to such women of services from the 
        facilities and the fact that the women receive such 
        preference.
    (b) Referrals Regarding States.--A funding agreement for a 
grant under section 1921 is that, in carrying out subsection 
(a)(1)--
            (1) the State involved will require that, in the 
        event that a treatment facility has insufficient 
        capacity to provide treatment services to any woman 
        described in such subsection who seeks the services 
        from the facility, the facility refer the woman to the 
        State; and
            (2) the State, in the case of each woman for whom a 
        referral under paragraph (1) is made to the State--
                    (A) will refer the woman to a treatment 
                facility that has the capacity to provide 
                treatment services to the woman; or
                    (B) will, if no treatment facility has the 
                capacity to admit the woman, make interim 
                services available to the woman not later than 
                48 hours after the women \1\ seeks the 
                treatment services.
---------------------------------------------------------------------------
    \1\ So in law. See section 202 of Public Law 102-321 (106 Stat. 
396). Probably should be ``woman''.
---------------------------------------------------------------------------

 H4  deg.SEC. 1928. [300X-28] ADDITIONAL AGREEMENTS.

    (a) Improvement of Process for Appropriate Referrals for 
Treatment.--With respect to individuals seeking treatment 
services, a funding agreement for a grant under section 1921 is 
that the State involved will improve (relative to fiscal year 
1992) the process in the State for referring the individuals to 
treatment facilities that can provide to the individuals the 
treatment modality that is most appropriate for the 
individuals.
    (b) Continuing Education.--With respect to any facility for 
treatment services or prevention actitivities \2\ that is 
receiving amounts from a grant under section 1921, a funding 
agreement for a State for a grant under such section is that 
continuing education in such services or activities (or both, 
as the case may be) will be made available to employees of the 
facility who provide the services or activities.
---------------------------------------------------------------------------
    \2\ So in law. See section 202 of Public Law 102-321 (106 Stat. 
396). Probably should be ``activities''.
---------------------------------------------------------------------------
    (c) Coordination of Various Activities and Services.--A 
funding agreement for a grant under section 1921 is that the 
State involved will coordinate prevention and treatment 
activities with the provision of other appropriate services 
(including health, social, correctional and criminal justice, 
educational, vocational rehabilitation, and employment 
services).
    (d) \1\ Waiver of Requirement.--
---------------------------------------------------------------------------
    \1\Paragraph (2)(B) of section 3303(f) of Public Law 106-310 (114 
Stat. 1211) provides as follows:

          (2) Conforming amendments.--Effective upon the publication of 
        the regulations developed in accordance with section 1932(e)(1) 
        of the Public Health Service Act (42 U.S.C. 300x-32(d))--

                  (A) * * *
                  (B) section 1928(d) of the Public Health Service Act 
                (42 U.S.C. 300x-28(d)) is repealed.
            (1) In general.--Upon the request of a State, the 
        Secretary may provide to a State a waiver of any or all 
        of the requirements established in this section if the 
        Secretary determines that, with respect to services for 
        the prevention and treatment of substance abuse, the 
        requirement involved is unnecessary for maintaining 
        quality in the provision of such services in the State.
            (2) Date certain for acting upon request.--The 
        Secretary shall approve or deny a request for a waiver 
        under paragraph (1) not later than 120 days after the 
        date on which the request is made.
            (3) Applicability of waiver.--Any waiver provided 
        by the Secretary under paragraph (1) shall be 
        applicable only to the fiscal year involved.

 H4  deg.SEC. 1929. [300X-29] SUBMISSION TO SECRETARY OF 
                    STATEWIDE ASSESSMENT OF NEEDS.

    The Secretary may make a grant under section 1921 only if 
the State submits to the Secretary an assessment of the need in 
the State for authorized activities (which assessment is 
conducted in accordance with criteria issued by the Secretary), 
both by locality and by the State in general, which assessment 
includes a description of--
            (1) the incidence and prevalence in the State of 
        drug abuse and the incidence and prevalence in the 
        State of alcohol abuse and alcoholism;
            (2) current prevention and treatment activities in 
        the State;
            (3) the need of the State for technical assistance 
        to carry out such activities;
            (4) efforts by the State to improve such 
        activities; and
            (5) the extent to which the availability of such 
        activities is insufficient to meet the need for the 
        activities, the interim services to be made available 
        under sections 1923(a) and 1927(b), and the manner in 
        which such services are to be so available.

 H4  deg.SEC. 1930. [300X-30] MAINTENANCE OF EFFORT REGARDING 
                    STATE EXPENDITURES.

    (a) In General.--With respect to the principal agency of a 
State for carrying out authorized activities, a funding 
agreement for a grant under section 1921 for the State for a 
fiscal year is that such agency will for such year maintain 
aggregate State expenditures for authorized activities at a 
level that is not less than the average level of such 
expenditures maintained by the State for the 2-year period 
preceding the fiscal year for which the State is applying for 
the grant.
    (b) Exclusion of Certain Funds.--The Secretary may exclude 
from the aggregate State expenditures under subsection (a), 
funds appropriated to the principle agency for authorized 
activities which are of a non-recurring nature and for a 
specific purpose.
    (c) Waiver.--
            (1) In general.--Upon the request of a State, the 
        Secretary may waive all or part of the requirement 
        established in subsection (a) if the Secretary 
        determines that extraordinary economic conditions in 
        the State justify the waiver.
            (2) Date certain for acting upon request.--The 
        Secretary shall approve or deny a request for a waiver 
        under paragraph (1) not later than 120 days after the 
        date on which the request is made.
            (3) Applicability of waiver.--Any waiver provided 
        by the Secretary under paragraph (1) shall be 
        applicable only to the fiscal year involved.
    (d) Noncompliance by State.--
            (1) In general.--In making a grant under section 
        1921 to a State for a fiscal year, the Secretary shall 
        make a determination of whether, for the previous 
        fiscal year, the State maintained material compliance 
        with any agreement made under subsection (a). If the 
        Secretary determines that a State has failed to 
        maintain such compliance, the Secretary shall reduce 
        the amount of the allotment under section 1921 for the 
        State for the fiscal year for which the grant is being 
        made by an amount equal to the amount constituting such 
        failure for the previous fiscal year.
            (2) Submission of information to secretary.--The 
        Secretary may make a grant under section 1921 for a 
        fiscal year only if the State involved submits to the 
        Secretary information sufficient for the Secretary to 
        make the determination required in paragraph (1).

 H4  deg.SEC. 1931. [300X-31] RESTRICTIONS ON EXPENDITURE OF 
                    GRANT.

    (a) In General.--
            (1) Certain restrictions.--A funding agreement for 
        a grant under section 1921 is that the State involved 
        will not expend the grant--
                    (A) to provide inpatient hospital services, 
                except as provided in subsection (b);
                    (B) to make cash payments to intended 
                recipients of health services;
                    (C) to purchase or improve land, purchase, 
                construct, or permanently improve (other than 
                minor remodeling) any building or other 
                facility, or purchase major medical equipment;
                    (D) to satisfy any requirement for the 
                expenditure of non-Federal funds as a condition 
                for the receipt of Federal funds;
                    (E) to provide financial assistance to any 
                entity other than a public or nonprofit private 
                entity; or
                    (F) to carry out any program prohibited by 
                section 256(b) of the Health Omnibus Programs 
                Extension of 1988 (42 U.S.C. 300ee-5).
            (2) Limitation on administrative expenses.--A 
        funding agreement for a grant under section 1921 is 
        that the State involved will not expend more than 5 
        percent of the grant to pay the costs of administering 
        the grant.
            (3) Limitation regarding penal and correctional 
        institutions.--A funding agreement for a State for a 
        grant under section 1921 is that, in expending the 
        grant for the purpose of providing treatment services 
        in penal or correctional institutions of the State, the 
        State will not expend more than an amount equal to the 
        amount expended for such purpose by the State from the 
        grant made under section 1912A to the State for fiscal 
        year 1991 (as section 1912A was in effect for such 
        fiscal year).
    (b) Exception Regarding Inpatient Hospital Services.--
            (1) Medical necessity as precondition.--With 
        respect to compliance with the agreement made under 
        subsection (a), a State may expend a grant under 
        section 1921 to provide inpatient hospital services as 
        treatment for substance abuse only if it has been 
        determined, in accordance with guidelines issued by the 
        Secretary, that such treatment is a medical necessity 
        for the individual involved, and that the individual 
        cannot be effectively treated in a community-based, 
        nonhospital, residential program of treatment.
            (2) Rate of payment.--In the case of an individual 
        for whom a grant under section 1921 is expended to 
        provide inpatient hospital services described in 
        paragraph (1), a funding agreement for the grant for 
        the State involved is that the daily rate of payment 
        provided to the hospital for providing the services to 
        the individual will not exceed the comparable daily 
        rate provided for community-based, nonhospital, 
        residential programs of treatment for substance abuse.
    (c) Waiver Regarding Construction of Facilities.--
            (1) In general.--The Secretary may provide to any 
        State a waiver of the restriction established in 
        subsection (a)(1)(C) for the purpose of authorizing the 
        State to expend a grant under section 1921 for the 
        construction of a new facility or rehabilitation of an 
        existing facility, but not for land acquisition.
            (2) Standard regarding need for waiver.--The 
        Secretary may approve a waiver under paragraph (1) only 
        if the State demonstrates to the Secretary that 
        adequate treatment cannot be provided through the use 
        of existing facilities and that alternative facilities 
        in existing suitable buildings are not available.
            (3) Amount.--In granting a waiver under paragraph 
        (1), the Secretary shall allow the use of a specified 
        amount of funds to construct or rehabilitate a 
        specified number of beds for residential treatment and 
        a specified number of slots for outpatient treatment, 
        based on reasonable estimates by the State of the costs 
        of construction or rehabilitation. In considering 
        waiver applications, the Secretary shall ensure that 
        the State has carefully designed a program that will 
        minimize the costs of additional beds.
            (4) Matching funds.--The Secretary may grant a 
        waiver under paragraph (1) only if the State agrees, 
        with respect to the costs to be incurred by the State 
        in carrying out the purpose of the waiver, to make 
        available non-Federal contributions in cash toward such 
        costs in an amount equal to not less than $1 for each 
        $1 of Federal funds provided under section 1921.
            (5) Date certain for acting upon request.--The 
        Secretary shall act upon a request for a waiver under 
        paragraph (1) not later than 120 days after the date on 
        which the request is made.

 H4  deg.SEC. 1932. [300X-32] APPLICATION FOR GRANT; APPROVAL 
                    OF STATE PLAN.

    (a) In General.--For purposes of section 1921, an 
application for a grant under such section for a fiscal year is 
in accordance with this section if, subject to subsections (c) 
and (d)(2)--
            (1) the application is received by the Secretary 
        not later than October 1 of the fiscal year for which 
        the State is seeking funds;
            (2) the application contains each funding agreement 
        that is described in this subpart or subpart III for 
        such a grant (other than any such agreement that is not 
        applicable to the State);
            (3) the agreements are made through certification 
        from the chief executive officer of the State;
            (4) with respect to such agreements, the 
        application provides assurances of compliance 
        satisfactory to the Secretary;
            (5) the application contains the information 
        required in section 1929, the information required in 
        section 1930(c)(2), and the report required in section 
        1942(a);
            (6)(A) the application contains a plan in 
        accordance with subsection (b) and the plan is approved 
        by the Secretary; and
            (B) the State provides assurances satisfactory to 
        the Secretary that the State complied with the 
        provisions of the plan under subparagraph (A) that was 
        approved by the Secretary for the most recent fiscal 
        year for which the State received a grant under section 
        1921; and
            (7) the application (including the plan under 
        paragraph (6)) is otherwise in such form, is made in 
        such manner, and contains such agreements, assurances, 
        and information as the Secretary determines to be 
        necessary to carry out this subpart.
    (b) State Plan.--
            (1) In general.--A plan submitted by a State under 
        subsection (a)(6) is in accordance with this subsection 
        if the plan contains detailed provisions for complying 
        with each funding agreement for a grant under section 
        1921 that is applicable to the State, including a 
        description of the manner in which the State intends to 
        expend the grant.
            (2) Authority of secretary regarding 
        modifications.--As a condition of making a grant under 
        section 1921 to a State for a fiscal year, the 
        Secretary may require that the State modify any 
        provision of the plan submitted by the State under 
        subsection (a)(6) (including provisions on priorities 
        in carrying out authorized activities). If the 
        Secretary approves the plan and makes the grant to the 
        State for the fiscal year, the Secretary may not during 
        such year require the State to modify the plan.
            (3) Authority of center for substance abuse 
        prevention.--With respect to plans submitted by the 
        States under subsection (a)(6), the Secretary, acting 
        through the Director of the Center for Substance Abuse 
        Prevention, shall review and approve or disapprove the 
        provisions of the plans that relate to prevention 
        activities.
    (c) Waivers Regarding Certain Territories.--In the case of 
any territory of the United States except Puerto Rico, the 
Secretary may waive such provisions of this subpart and subpart 
III as the Secretary determines to be appropriate, other than 
the provisions of section 1931.
    (d) Issuance of Regulations; Precondition to Making 
Grants.--
            (1) Regulations.--Not later than August 25, 1992, 
        the Secretary, acting as appropriate through the 
        Director of the Center for Treatment Improvement or the 
        Director of the Center for Substance Abuse Prevention, 
        shall by regulation establish standards specifying the 
        circumstances in which the Secretary will consider an 
        application for a grant under section 1921 to be in 
        accordance with this section.
            (2) Issuance as precondition to making grants.--The 
        Secretary may not make payments under any grant under 
        section 1921 for fiscal year 1993 on or after January 
        1, 1993, unless the Secretary has issued standards 
        under paragraph (1).
    (e) Waiver Authority for Certain Requirements.--
            (1) In general.--Upon the request of a State, the 
        Secretary may waive the requirements of all or part of 
        the sections described in paragraph (2) using objective 
        criteria established by the Secretary by regulation 
        after consultation with the States and other interested 
        parties including consumers and providers.
            (2) Sections.--The sections described in paragraph 
        (1) are sections 1922(c), 1923, 1924 and 1928.
            (3) Date certain for acting upon request.--The 
        Secretary shall approve or deny a request for a waiver 
        under paragraph (1) and inform the State of that 
        decision not later than 120 days after the date on 
        which the request and all the information needed to 
        support the request are submitted.
            (4) Annual reporting requirement.--The Secretary 
        shall annually report to the general public on the 
        States that receive a waiver under this subsection.

 H4  deg.SEC. 1933. [300X-33] DETERMINATION OF AMOUNT OF 
                    ALLOTMENT.

    (a) States.--
            (1) In general.--Subject to subsection (b), the 
        Secretary shall determine the amount of the allotment 
        required in section 1921 for a State for a fiscal year 
        as follows:
                    (A) The formula established in paragraph 
                (1) of section 1918(a) shall apply to this 
                subsection to the same extent and in the same 
                manner as the formula applies for purposes of 
                section 1918(a), except that, in the 
                application of such formula for purposes of 
                this subsection, the modifications described in 
                subparagraph (B) shall apply.
                    (B) For purposes of subparagraph (A), the 
                modifications described in this subparagraph 
                are as follows:
                            (i) The amount specified in 
                        paragraph (2)(A) of section 1918(a) is 
                        deemed to be the amount appropriated 
                        under section 1935(a) for allotments 
                        under section 1921 for the fiscal year 
                        involved.
                            (ii) The term ``P'' is deemed to 
                        have the meaning given in paragraph (2) 
                        of this subsection. Section 
                        1918(a)(5)(B) applies to the data used 
                        in determining such term for the 
                        States.
                            (iii) The factor determined under 
                        paragraph (8) of section 1918(a) is 
                        deemed to have the purpose of 
                        reflecting the differences that exist 
                        between the State involved and other 
                        States in the costs of providing 
                        authorized services.
            (2) Determination of term ``p''.--For purposes of 
        this subsection, the term ``P'' means the percentage 
        that is the arithmetic mean of the percentage 
        determined under subparagraph (A) and the percentage 
        determined under subparagraph (B), as follows:
                    (A) The percentage constituted by the ratio 
                of--
                            (i) an amount equal to the sum of 
                        the total number of individuals who 
                        reside in the State involved and are 
                        between 18 and 24 years of age 
                        (inclusive) and the number of 
                        individuals in the State who reside in 
                        urbanized areas of the State and are 
                        between such years of age; to
                            (ii) an amount equal to the total 
                        of the respective sums determined for 
                        the States under clause (i).
                    (B) The percentage constituted by the ratio 
                of--
                            (i) the total number of individuals 
                        in the State who are between 25 and 64 
                        years of age (inclusive); to
                            (ii) an amount equal to the sum of 
                        the respective amounts determined for 
                        the States under clause (i).
    (b) Minimum Allotments for States.--
            (1) In general.--With respect to fiscal year 2000, 
        and each subsequent fiscal year, the amount of the 
        allotment of a State under section 1921 shall not be 
        less than the amount the State received under such 
        section for the previous fiscal year increased by an 
        amount equal to 30.65 percent of the percentage by 
        which the aggregate amount allotted to all States for 
        such fiscal year exceeds the aggregate amount allotted 
        to all States for the previous fiscal year.
            (2) Limitations.--
                    (A) In general.--Except as provided in 
                subparagraph (B), a State shall not receive an 
                allotment under section 1921 for a fiscal year 
                in an amount that is less than an amount equal 
                to 0.375 percent of the amount appropriated 
                under section 1935(a) for such fiscal year.
                    (B) Exception.--In applying subparagraph 
                (A), the Secretary shall ensure that no State 
                receives an increase in its allotment under 
                section 1921 for a fiscal year (as compared to 
                the amount allotted to the State in the prior 
                fiscal year) that is in excess of an amount 
                equal to 300 percent of the percentage by which 
                the amount appropriated under section 1935(a) 
                for such fiscal year exceeds the amount 
                appropriated for the prior fiscal year.
            (3) Decrease in or equal appropriations.--If the 
        amount appropriated under section 1935(a) for a fiscal 
        year is equal to or less than the amount appropriated 
        under such section for the prior fiscal year, the 
        amount of the State allotment under section 1921 shall 
        be equal to the amount that the State received under 
        section 1921 in the prior fiscal year decreased by the 
        percentage by which the amount appropriated for such 
        fiscal year is less than the amount appropriated or 
        such section for the prior fiscal year.
    (c) Territories.--
            (1) Determination under formula.--Subject to 
        paragraphs (2) and (4), the amount of an allotment 
        under section 1921 for a territory of the United States 
        for a fiscal year shall be the product of--
                    (A) an amount equal to the amounts reserved 
                under paragraph (3) for the fiscal year; and
                    (B) a percentage equal to the quotient of--
                            (i) the civilian population of the 
                        territory, as indicated by the most 
                        recently available data; divided by
                            (ii) the aggregate civilian 
                        population of the territories of the 
                        United States, as indicated by such 
                        data.
            (2) Minimum allotment for territories.--The amount 
        of an allotment under section 1921 for a territory of 
        the United States for a fiscal year shall be the 
        greater of--
                    (A) the amount determined under paragraph 
                (1) for the territory for the fiscal year;
                    (B) $50,000; and
                    (C) with respect to fiscal years 1993 and 
                1994, an amount equal to 79.4 percent of the 
                amount received by the territory from 
                allotments made pursuant to this part for 
                fiscal year 1992.
            (3) Reservation of amounts.--The Secretary shall 
        each fiscal year reserve for the territories of the 
        United States 1.5 percent of the amounts appropriated 
        under section 1935(a) for allotments under section 1921 
        for the fiscal year.
            (4) Availability of data on population.--With 
        respect to data on the civilian population of the 
        territories of the United States, if the Secretary 
        determines for a fiscal year that recent such data for 
        purposes of paragraph (1)(B) do not exist regarding a 
        territory, the Secretary shall for such purposes 
        estimate the civilian population of the territory by 
        modifying the data on the territory to reflect the 
        average extent of change occurring during the ensuing 
        period in the population of all territories with 
        respect to which recent such data do exist.
            (5) Applicability of certain provisions.--For 
        purposes of subsections (a) and (b), the term ``State'' 
        does not include the territories of the United States.
    (d) Indian tribes and tribal organizations.--
            (1) In general.--If the Secretary--
                    (A) receives a request from the governing 
                body of an Indian tribe or tribal organization 
                within any State that funds under this subpart 
                be provided directly by the Secretary to such 
                tribe or organization; and
                    (B) makes a determination that the members 
                of such tribe or tribal organization would be 
                better served by means of grants made directly 
                by the Secretary under this; \1\
---------------------------------------------------------------------------
    \1\ So in law. See section 102 of Public Law 102-321 (106 Stat. 
402). Probably should be ``under this subpart''.
---------------------------------------------------------------------------
        the Secretary shall reserve from the allotment under 
        section 1921 for the State for the fiscal year involved 
        an amount that bears the same ratio to the allotment as 
        the amount provided under this subpart to the tribe or 
        tribal organization for fiscal year 1991 for activities 
        relating to the prevention and treatment of the abuse 
        of alcohol and other drugs bore to the amount of the 
        portion of the allotment under this subpart for the 
        State for such fiscal year that was expended for such 
        activities.
            (2) Tribe or tribal organization as grantee.--The 
        amount reserved by the Secretary on the basis of a 
        determination under this paragraph \2\ shall be granted 
        to the Indian tribe or tribal organization serving the 
        individuals for whom such a determination has been 
        made.
---------------------------------------------------------------------------
    \2\ So in law. See section 102 of Public Law 102-321 (106 Stat. 
402). Probably should be ``subsection''.
---------------------------------------------------------------------------
            (3) Application.--In order for an Indian tribe or 
        tribal organization to be eligible for a grant for a 
        fiscal year under this paragraph, it shall submit to 
        the Secretary a plan for such fiscal year that meets 
        such criteria as the Secretary may prescribe.
            (4) Definition.--The terms ``Indian tribe'' and 
        ``tribal organization'' have the same meaning given 
        such terms in subsections (b) and (c) of section 4 of 
        the Indian Self-Determination and Education Assistance 
        Act.

 H4  deg.SEC. 1934. [300X-34] DEFINITIONS.

    For purposes of this subpart:
            (1) The term ``authorized activities'', subject to 
        section 1931, means the activities described in section 
        1921(b).
            (2) The term ``funding agreement'', with respect to 
        a grant under section 1921 to a State, means that the 
        Secretary may make such a grant only if the State makes 
        the agreement involved.
            (3) The term ``prevention activities'', subject to 
        section 1931, means activities to prevent substance 
        abuse.
            (4) The term ``substance abuse'' means the abuse of 
        alcohol or other drugs.
            (5) The term ``treatment activities'' means 
        treatment services and, subject to section 1931, 
        authorized activities that are related to treatment 
        services.
            (6) The term ``treatment facility'' means an entity 
        that provides treatment services.
            (7) The term ``treatment services'', subject to 
        section 1931, means treatment for substance abuse.

 H4  deg.SEC. 1935. [300X-35] FUNDING.

    (a) Authorization of Appropriations.--For the purpose of 
carrying out this subpart, subpart III and section 505 with 
respect to substance abuse, and section 515(d), there are 
authorized to be appropriated $2,000,000,000 for fiscal year 
2001, and such sums as may be necessary for each of the fiscal 
years 2002 and 2003.
    (b) Allocations for Technical Assistance, National Data 
Base, Data Collection, and Program Evaluations.--
            (1) In general.--
                    (A) For the purpose of carrying out section 
                1948(a) with respect to substance abuse, 
                section 515(d), and the purposes specified in 
                subparagraphs (B) and (C), the Secretary shall 
                obligate 5 percent of the amounts appropriated 
                under subsection (a) each fiscal year.
                    (B) The purpose specified in this 
                subparagraph is the collection of data in this 
                paragraph \1\ is carrying out sections 505 and 
                1971 with respect to substance abuse.
---------------------------------------------------------------------------
    \1\ So in law. See section 202 of Public Law 102-321 (106 Stat. 
403). The words ``the collection of data in this paragraph'' probably 
should not appear.
---------------------------------------------------------------------------
                    (C) The purpose specified in this 
                subparagraph is the conduct of evaluations of 
                authorized activities to determine methods for 
                improving the availability and quality of such 
                activities.
            (2) Activities of center for substance abuse 
        prevention.--Of the amounts reserved under paragraph 
        (1) for a fiscal year, the Secretary, acting through 
        the Director of the Center for Substance Abuse 
        Prevention, shall obligate 20 percent for carrying out 
        paragraph (1)(C), section 1948(a) with respect to 
        prevention activities, and section 515(d).
            (3) Core data set.--A State that receives a new 
        grant, contract, or cooperative agreement from amounts 
        available to the Secretary under paragraph (1), for the 
        purposes of improving the data collection, analysis and 
        reporting capabilities of the State, shall be required, 
        as a condition of receipt of funds, to collect, 
        analyze, and report to the Secretary for each fiscal 
        year subsequent to receiving such funds a core data set 
        to be determined by the Secretary in conjunction with 
        the States.

                    Subpart III--General Provisions

 H4  deg.SEC. 1941. [300X-51] OPPORTUNITY FOR PUBLIC COMMENT 
                    ON STATE PLANS.

    A funding agreement for a grant under section 1911 or 1921 
is that the State involved will make the plan required in 
section 1912, and the plan required in section 1932, 
respectively, public within the State in such manner as to 
facilitate comment from any person (including any Federal or 
other public agency) during the development of the plan 
(including any revisions) and after the submission of the plan 
to the Secretary.

 H4  deg.SEC. 1942. [300X-52] REQUIREMENT OF REPORTS AND 
                    AUDITS BY STATES.

    (a) Report.--A funding agreement for a grant under section 
1911 or 1921 is that the State involved will submit to the 
Secretary a report in such form and containing such information 
as the Secretary determines (after consultation with the 
States) to be necessary for securing a record and a description 
of--
            (1) the purposes for which the grant received by 
        the State for the preceding fiscal year under the 
        program involved were expended and a description of the 
        activities of the State under the program; and
            (2) the recipients of amounts provided in the 
        grant.
    (b) Audits.--A funding agreement for a grant under section 
1911 or 1921 is that the State will, with respect to the grant, 
comply with chapter 75 of title 31, United States Code.
    (c) Availability to Public.--A funding agreement for a 
grant under section 1911 or 1921 is that the State involved 
will--
            (1) make copies of the reports and audits described 
        in this section available for public inspection within 
        the State; and
            (2) provide copies of the report under subsection 
        (a), upon request, to any interested person (including 
        any public agency).

 H4  deg.SEC. 1943. [300X-53] ADDITIONAL REQUIREMENTS.

    (a) In General.--A funding agreement for a grant under 
section 1911 or 1921 is that the State involved will--
            (1)(A) for the fiscal year for which the grant 
        involved is provided, provide for independent peer 
        review to assess the quality, appropriateness, and 
        efficacy of treatment services provided in the State to 
        individuals under the program involved; and
            (B) ensure that, in the conduct of such peer 
        review, not fewer than 5 percent of the entities 
        providing services in the State under such program are 
        reviewed (which 5 percent is representative of the 
        total population of such entities);
            (2) permit and cooperate with Federal 
        investigations undertaken in accordance with section 
        1945; and
            (3) provide to the Secretary any data required by 
        the Secretary pursuant to section 505 and will 
        cooperate with the Secretary in the development of 
        uniform criteria for the collection of data pursuant to 
        such section.
    (b) Patient Records.--The Secretary may make a grant under 
section 1911 or 1921 only if the State involved has in effect a 
system to protect from inappropriate disclosure patient records 
maintained by the State in connection with an activity funded 
under the program involved or by any entity which is receiving 
amounts from the grant.

 H4  deg.SEC. 1944. [300X-54] DISPOSITION OF CERTAIN FUNDS 
                    APPROPRIATED FOR ALLOTMENTS.

    (a) In General.--Amounts described in subsection (b) and 
available for a fiscal year pursuant to section 1911 or 1921, 
as the case may be, shall be allotted by the Secretary and paid 
to the States receiving a grant under the program involved, 
other than any State referred to in subsection (b) with respect 
to such program. Such amounts shall be allotted in a manner 
equivalent to the manner in which the allotment under the 
program involved was determined.
    (b) Specification of Amounts.--The amounts referred to in 
subsection (a) are any amounts that--
            (1) are not paid to States under the program 
        involved as a result of--
                    (A) the failure of any State to submit an 
                application in accordance with the program;
                    (B) the failure of any State to prepare 
                such application in compliance with the 
                program; or
                    (C) any State informing the Secretary that 
                the State does not intend to expend the full 
                amount of the allotment made to the State under 
                the program;
            (2) are terminated, repaid, or offset under section 
        1945;
            (3) in the case of the program established in 
        section 1911, are available as a result of reductions 
        in allotments under such section pursuant to section 
        1912(d) or 1915(b); or
            (4) in the case of the program established in 
        section 1921, are available as a result of reductions 
        in allotments under such section pursuant to section 
        1926 or 1930.

 H4  deg.SEC. 1945. [300X-55] FAILURE TO COMPLY WITH 
                    AGREEMENTS.

    (a) Suspension or Termination of Payments.--Subject to 
subsection (e), if the Secretary determines that a State has 
materially failed to comply with the agreements or other 
conditions required for the receipt of a grant under the 
program involved, the Secretary may in whole or in part suspend 
payments under the grant, terminate the grant for cause, or 
employ such other remedies (including the remedies provided for 
in subsections (b) and (c)) as may be legally available and 
appropriate in the circumstances involved.
    (b) Repayment of Payments.--
            (1) In general.--Subject to subsection (e), the 
        Secretary may require a State to repay with interest 
        any payments received by the State under section 1911 
        or 1921 that the Secretary determines were not expended 
        by the State in accordance with the agreements required 
        under the program involved.
            (2) Offset against payments.--If a State fails to 
        make a repayment required in paragraph (1), the 
        Secretary may offset the amount of the repayment 
        against the amount of any payment due to be paid to the 
        State under the program involved.
    (c) Withholding of Payments.--
            (1) In general.--Subject to subsections (e) and 
        (g)(3), the Secretary may withhold payments due under 
        section 1911 or 1921 if the Secretary determines that 
        the State involved is not expending amounts received 
        under the program involved in accordance with the 
        agreements required under the program.
            (2) Termination of withholding.--The Secretary 
        shall cease withholding payments from a State under 
        paragraph (1) if the Secretary determines that there 
        are reasonable assurances that the State will expend 
        amounts received under the program involved in 
        accordance with the agreements required under the 
        program.
    (d) Applicability of Remedies to Certain Violations.--
            (1) In general.--With respect to agreements or 
        other conditions for receiving a grant under the 
        program involved, in the case of the failure of a State 
        to maintain material compliance with a condition 
        referred to in paragraph (2), the provisions for 
        noncompliance with the condition that are provided in 
        the section establishing the condition shall apply in 
        lieu of subsections (a) through (c) of this section.
            (2) Relevant conditions.--For purposes of paragraph 
        (1):
                    (A) In the case of the program established 
                in section 1911, a condition referred to in 
                this paragraph is the condition established in 
                section 1912(d) and the condition established 
                in section 1915(b).
                    (B) In the case of the program established 
                in section 1921, a condition referred to in 
                this paragraph is the condition established in 
                section 1926 and the condition established in 
                section 1930.
    (e) Opportunity for Hearing.--Before taking action against 
a State under any of subsections (a) through (c) (or under a 
section referred to in subsection (d)(2), as the case may be), 
the Secretary shall provide to the State involved adequate 
notice and an opportunity for a hearing.
    (f) Requirement of Hearing in Certain Circumstances.--
            (1) In general.--If the Secretary receives a 
        complaint that a State has failed to maintain material 
        compliance with the agreements or other conditions 
        required for receiving a grant under the program 
        involved (including any condition referred to for 
        purposes of subsection (d)), and there appears to be 
        reasonable evidence to support the complaint, the 
        Secretary shall promptly conduct a hearing with respect 
        to the complaint.
            (2) Finding of material noncompliance.--If in a 
        hearing under paragraph (1) the Secretary finds that 
        the State involved has failed to maintain material 
        compliance with the agreement or other condition 
        involved, the Secretary shall take such action under 
        this section as may be appropriate to ensure that 
        material compliance is so maintained, or such action as 
        may be required in a section referred to in subsection 
        (d)(2), as the case may be.
    (g) Certain Investigations.--
            (1) Requirement regarding secretary.--The Secretary 
        shall in fiscal year 1994 and each subsequent fiscal 
        year conduct in not less than 10 States investigations 
        of the expenditure of grants received by the States 
        under section 1911 or 1921 in order to evaluate 
        compliance with the agreements required under the 
        program involved.
            (2) Provision of records etc. upon request.--Each 
        State receiving a grant under section 1911 or 1921, and 
        each entity receiving funds from the grant, shall make 
        appropriate books, documents, papers, and records 
        available to the Secretary or the Comptroller General, 
        or any of their duly authorized representatives, for 
        examination, copying, or mechanical reproduction on or 
        off the premises of the appropriate entity upon a 
        reasonable request therefor.
            (3) Limitations on authority.--The Secretary may 
        not institute proceedings under subsection (c) unless 
        the Secretary has conducted an investigation concerning 
        whether the State has expended payments under the 
        program involved in accordance with the agreements 
        required under the program. Any such investigation 
        shall be conducted within the State by qualified 
        investigators.

 H4  deg.SEC. 1946. [300X-56] PROHIBITIONS REGARDING RECEIPT 
                    OF FUNDS.

    (a) Establishment.--
            (1) Certain false statements and representations.--
        A person shall not knowingly and willfully make or 
        cause to be made any false statement or representation 
        of a material fact in connection with the furnishing of 
        items or services for which payments may be made by a 
        State from a grant made to the State under section 1911 
        or 1921.
            (2) Concealing or failing to disclose certain 
        events.--A person with knowledge of the occurrence of 
        any event affecting the initial or continued right of 
        the person to receive any payments from a grant made to 
        a State under section 1911 or 1921 shall not conceal or 
        fail to disclose any such event with an intent 
        fraudulently to secure such payment either in a greater 
        amount than is due or when no such amount is due.
    (b) Criminal Penalty for Violation of Prohibition.--Any 
person who violates any prohibition established in subsection 
(a) shall for each violation be fined in accordance with title 
18, United States Code, or imprisoned for not more than 5 
years, or both.

 H4  deg.SEC. 1947. [300X-57] NONDISCRIMINATION.

    (a) In General.--
            (1) Rule of construction regarding certain civil 
        rights laws.--For the purpose of applying the 
        prohibitions against discrimination on the basis of age 
        under the Age Discrimination Act of 1975, on the basis 
        of handicap under section 504 of the Rehabilitation Act 
        of 1973, on the basis of sex under title IX of the 
        Education Amendments of 1972, or on the basis of race, 
        color, or national origin under title VI of the Civil 
        Rights Act of 1964, programs and activities funded in 
        whole or in part with funds made available under 
        section 1911 or 1921 shall be considered to be programs 
        and activities receiving Federal financial assistance.
            (2) Prohibition.--No person shall on the ground of 
        sex (including, in the case of a woman, on the ground 
        that the woman is pregnant), or on the ground of 
        religion, be excluded from participation in, be denied 
        the benefits of, or be subjected to discrimination 
        under, any program or activity funded in whole or in 
        part with funds made available under section 1911 or 
        1921.
    (b) Enforcement.--
            (1) Referrals to attorney general after notice.--
        Whenever the Secretary finds that a State, or an entity 
        that has received a payment pursuant to section 1911 or 
        1921, has failed to comply with a provision of law 
        referred to in subsection (a)(1), with subsection 
        (a)(2), or with an applicable regulation (including one 
        prescribed to carry out subsection (a)(2)), the 
        Secretary shall notify the chief executive officer of 
        the State and shall request the chief executive officer 
        to secure compliance. If within a reasonable period of 
        time, not to exceed 60 days, the chief executive 
        officer fails or refuses to secure compliance, the 
        Secretary may--
                    (A) refer the matter to the Attorney 
                General with a recommendation that an 
                appropriate civil action be instituted;
                    (B) exercise the powers and functions 
                provided by the Age Discrimination Act of 1975, 
                section 504 of the Rehabilitation Act of 1973, 
                title IX of the Education Amendments of 1972, 
                or title VI of the Civil Rights Act of 1964, as 
                may be applicable; or
                    (C) take such other actions as may be 
                authorized by law.
            (2) Authority of attorney general.--When a matter 
        is referred to the Attorney General pursuant to 
        paragraph (1)(A), or whenever the Attorney General has 
        reason to believe that a State or an entity is engaged 
        in a pattern or practice in violation of a provision of 
        law referred to in subsection (a)(1) or in violation of 
        subsection (a)(2), the Attorney General may bring a 
        civil action in any appropriate district court of the 
        United States for such relief as may be appropriate, 
        including injunctive relief.

 H4  deg.SEC. 1948. [300X-58] TECHNICAL ASSISTANCE AND 
                    PROVISION OF SUPPLIES AND SERVICES IN LIEU OF GRANT 
                    FUNDS.

    (a) Technical Assistance.--The Secretary shall, without 
charge to a State receiving a grant under section 1911 or 1921, 
provide to the State (or to any public or nonprofit private 
entity within the State) technical assistance with respect to 
the planning, development, and operation of any program or 
service carried out pursuant to the program involved. The 
Secretary may provide such technical assistance directly, 
through contract, or through grants.
    (b) Provision of Supplies and Services in Lieu of Grant 
Funds.--
            (1) In general.--Upon the request of a State 
        receiving a grant under section 1911 or 1921, the 
        Secretary may, subject to paragraph (2), provide 
        supplies, equipment, and services for the purpose of 
        aiding the State in carrying out the program involved 
        and, for such purpose, may detail to the State any 
        officer or employee of the Department of Health and 
        Human Services.
            (2) Corresponding reduction in payments.--With 
        respect to a request described in paragraph (1), the 
        Secretary shall reduce the amount of payments under the 
        program involved to the State by an amount equal to the 
        costs of detailing personnel and the fair market value 
        of any supplies, equipment, or services provided by the 
        Secretary. The Secretary shall, for the payment of 
        expenses incurred in complying with such request, 
        expend the amounts withheld.

SEC. 1949. \1\ [300X-59] PLANS FOR PERFORMANCE PARTNERSHIPS.
---------------------------------------------------------------------------

    \1\ Section 1949 appears according to the probable intent of the 
Congress. Section 3403(a) of Public Law 106-310 (114 Stat. 1219) 
provides that the section ``is amended as follows:''. No amendatory 
instructions were then given, but a substitute text was provided. The 
amendment probably should have instructed that section 1949 ``is 
amended to read as follows:''.
---------------------------------------------------------------------------
    (a) Development.--The Secretary in conjunction with States 
and other interested groups shall develop separate plans for 
the programs authorized under subparts I and II for creating 
more flexibility for States and accountability based on outcome 
and other performance measures. The plans shall each include--
            (1) a description of the flexibility that would be 
        given to the States under the plan;
            (2) the common set of performance measures that 
        would be used for accountability, including measures 
        that would be used for the program under subpart II for 
        pregnant addicts, HIV transmission, tuberculosis, and 
        those with a co-occurring substance abuse and mental 
        disorders, and for programs under subpart I for 
        children with serious emotional disturbance and adults 
        with serious mental illness and for individuals with 
        co-occurring mental health and substance abuse 
        disorders;
            (3) the definitions for the data elements to be 
        used under the plan;
            (4) the obstacles to implementation of the plan and 
        the manner in which such obstacles would be resolved;
            (5) the resources needed to implement the 
        performance partnerships under the plan; and
            (6) an implementation strategy complete with 
        recommendations for any necessary legislation.
    (b) Submission.--Not later than 2 years after the date of 
the enactment of this Act \2\, the plans developed under 
subsection (a) shall be submitted to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee 
on Commerce of the House of Representatives.
---------------------------------------------------------------------------
    \2\ The probable intent of the Congress was that the reference to 
``this Act'' be a reference to the Children's Health Act of 2000 
(Public Law 106-310), which provided a substitute text for section 1949 
(see footnote 1), including subsection (b) above. That Act was enacted 
October 17, 2000. (A reference to ``this Act'' is a reference to the 
Public Health Service Act, which was enacted July 1, 1944.)
---------------------------------------------------------------------------
    (c) Information.--As the elements of the plans described in 
subsection (a) are developed, States are encouraged to provide 
information to the Secretary on a voluntary basis.
    (d) Participants.--The Secretary shall include among those 
interested groups that participate in the development of the 
plan consumers of mental health or substance abuse services, 
providers, representatives of political divisions of States, 
and representatives of racial and ethnic groups including 
Native Americans.

 H4  deg.SEC. 1950. [300X-60] RULE OF CONSTRUCTION REGARDING 
                    DELEGATION OF AUTHORITY TO STATES.

    With respect to States receiving grants under section 1911 
or 1921, this part may not be construed to authorize the 
Secretary to delegate to the States the primary responsibility 
for interpreting the governing provisions of this part.

SEC. 1951. [300X-61] SOLICITATION OF VIEWS OF CERTAIN ENTITIES.

    In carrying out this part, the Secretary, as appropriate, 
shall solicit the views of the States and other appropriate 
entities.

SEC. 1952. \1\ [300X-62] AVAILABILITY TO STATES OF GRANT PAYMENTS.
---------------------------------------------------------------------------

    \1\ Section 1952 appears according to the probable intent of the 
Congress. Section 3403(b) of Public Law 106-310 (114 Stat. 1220) 
provides that the section ``is amended as follows:''. No amendatory 
instructions were then given, but a substitute text was provided. The 
amendment probably should have instructed that section 1952 ``is 
amended to read as follows:''.
---------------------------------------------------------------------------
    Any amounts paid to a State for a fiscal year under section 
1911 or 1921 shall be available for obligation and expenditure 
until the end of the fiscal year following the fiscal year for 
which the amounts were paid.

SEC. 1953. [300X-63] CONTINUATION OF CERTAIN PROGRAMS.

    (a) In General.--Of the amount allotted to the State of 
Hawaii under section 1911, and the amount allotted to such 
State under section 1921, an amount equal to the proportion of 
Native Hawaiians residing in the State to the total population 
of the State shall be available, respectively, for carrying out 
the program involved for Native Hawaiians.
    (b) Expenditure of Amounts.--The amount made available 
under subsection (a) may be expended only through contracts 
entered into by the State of Hawaii with public and private 
nonprofit organizations to enable such organizations to plan, 
conduct, and administer comprehensive substance abuse and 
treatment programs for the benefit of Native Hawaiians. In 
entering into contracts under this section, the State of Hawaii 
shall give preference to Native Hawaiian organizations and 
Native Hawaiian health centers.
    (c) Definitions.--For the purposes of this subsection \2\, 
the terms ``Native Hawaiian'', ``Native Hawaiian 
organization'', and ``Native Hawaiian health center'' have the 
meaning given such terms in section 2308 of subtitle D of title 
II of the Anti-Drug Abuse Act of 1988.
---------------------------------------------------------------------------
    \2\ So in law. See section 203 of Public Law 102-321 (106 Stat. 
409). Probably should be ``section''.
---------------------------------------------------------------------------

 H4  deg.SEC. 1954. [300X-64] DEFINITIONS.

    (a) Definitions for Subpart III.--For purposes of this 
subpart:
            (1) The term ``program involved'' means the program 
        of grants established in section 1911 or 1921, or both, 
        as indicated by whether the State involved is receiving 
        or is applying to receive a grant under section 1911 or 
        1921, or both.
            (2)(A) The term ``funding agreement'', with respect 
        to a grant under section 1911, has the meaning given 
        such term in section 1919.
            (B) The term ``funding agreement'', with respect to 
        a grant under section 1921, has the meaning given such 
        term in section 1934.
    (b) Definitions for Part B.--For purposes of this part:
            (1) The term ``Comptroller General'' means the 
        Comptroller General of the United States.
            (2) The term ``State'', except as provided in 
        sections 1918(c)(5) and 1933(c)(5), means each of the 
        several States, the District of Columbia, and each of 
        the territories of the United States.
            (3) The term ``territories of the United States'' 
        means each of the Commonwealth of Puerto Rico, American 
        Samoa, Guam, the Commonwealth of the Northern Mariana 
        Islands, the Virgin Islands, Palau, the Marshall 
        Islands, and Micronesia.
            (4) The term ``interim services'', in the case of 
        an individual in need of treatment for substance abuse 
        who has been denied admission to a program of such 
        treatment on the basis of the lack of the capacity of 
        the program to admit the individual, means services for 
        reducing the adverse health effects of such abuse, for 
        promoting the health of the individual, and for 
        reducing the risk of transmission of disease, which 
        services are provided until the individual is admitted 
        to such a program.

SEC. 1955. [300X-65] SERVICES PROVIDED BY NONGOVERNMENTAL 
                    ORGANIZATIONS. \1\
---------------------------------------------------------------------------

    \1\ Part G of title V of this Act (the second part G; see page 677) 
also relates to religious organizations as providers of substance abuse 
services. That part was added by section 144 of the Community Renewal 
Tax Relief Act of 2000 (as enacted into law by section 1(a)(7) of 
Public Law 106-554; 114 Stat. 2763A-619). Section 1955 above was added 
by section 3305 of Public Law 106-310 (114 Stat. 1212).
---------------------------------------------------------------------------
    (a) Purposes.--The purposes of this section are--
            (1) to prohibit discrimination against 
        nongovernmental organizations and certain individuals 
        on the basis of religion in the distribution of 
        government funds to provide substance abuse services 
        under this title and title V, and the receipt of 
        services under such titles; and
            (2) to allow the organizations to accept the funds 
        to provide the services to the individuals without 
        impairing the religious character of the organizations 
        or the religious freedom of the individuals.
    (b) Religious Organizations Included as Nongovernmental 
Providers.--
            (1) In general.--A State may administer and provide 
        substance abuse services under any program under this 
        title or title V through grants, contracts, or 
        cooperative agreements to provide assistance to 
        beneficiaries under such titles with nongovernmental 
        organizations.
            (2) Requirement.--A State that elects to utilize 
        nongovernmental organizations as provided for under 
        paragraph (1) shall consider, on the same basis as 
        other nongovernmental organizations, religious 
        organizations to provide services under substance abuse 
        programs under this title or title V, so long as the 
        programs under such titles are implemented in a manner 
        consistent with the Establishment Clause of the first 
        amendment to the Constitution. Neither the Federal 
        Government nor a State or local government receiving 
        funds under such programs shall discriminate against an 
        organization that provides services under, or applies 
        to provide services under, such programs, on the basis 
        that the organization has a religious character.
    (c) Religious Character and Independence.--
            (1) In general.--A religious organization that 
        provides services under any substance abuse program 
        under this title or title V shall retain its 
        independence from Federal, State, and local 
        governments, including such organization's control over 
        the definition, development, practice, and expression 
        of its religious beliefs.
            (2) Additional safeguards.--Neither the Federal 
        Government nor a State or local government shall 
        require a religious organization--
                    (A) to alter its form of internal 
                governance; or
                    (B) to remove religious art, icons, 
                scripture, or other symbols,
        in order to be eligible to provide services under any 
        substance abuse program under this title or title V.
    (d) Employment Practices.--
            (1) Substance abuse.--A religious organization that 
        provides services under any substance abuse program 
        under this title or title V may require that its 
        employees providing services under such program adhere 
        to rules forbidding the use of drugs or alcohol.
            (2) Title vii exemption.--The exemption of a 
        religious organization provided under section 702 or 
        703(e)(2) of the Civil Rights Act of 1964 (42 U.S.C. 
        2000e-1, 2000e-2(e)(2)) regarding employment practices 
        shall not be affected by the religious organization's 
        provision of services under, or receipt of funds from, 
        any substance abuse program under this title or title 
        V.
    (e) Rights of Beneficiaries of Assistance.--
            (1) In general.--If an individual described in 
        paragraph (3) has an objection to the religious 
        character of the organization from which the individual 
        receives, or would receive, services funded under any 
        substance abuse program under this title or title V, 
        the appropriate Federal, State, or local governmental 
        entity shall provide to such individual (if otherwise 
        eligible for such services) within a reasonable period 
        of time after the date of such objection, services 
        that--
                    (A) are from an alternative provider that 
                is accessible to the individual; and
                    (B) have a value that is not less than the 
                value of the services that the individual would 
                have received from such organization.
            (2) Notice.--The appropriate Federal, State, or 
        local governmental entity shall ensure that notice is 
        provided to individuals described in paragraph (3) of 
        the rights of such individuals under this section.
            (3) Individual described.--An individual described 
        in this paragraph is an individual who receives or 
        applies for services under any substance abuse program 
        under this title or title V.
    (f ) Nondiscrimination Against Beneficiaries.--A religious 
organization providing services through a grant, contract, or 
cooperative agreement under any substance abuse program under 
this title or title V shall not discriminate, in carrying out 
such program, against an individual described in subsection 
(e)(3) on the basis of religion, a religious belief, a refusal 
to hold a religious belief, or a refusal to actively 
participate in a religious practice.
    (g) Fiscal Accountability.--
            (1) In general.--Except as provided in paragraph 
        (2), any religious organization providing services 
        under any substance abuse program under this title or 
        title V shall be subject to the same regulations as 
        other nongovernmental organizations to account in 
        accord with generally accepted accounting principles 
        for the use of such funds provided under such program.
            (2) Limited audit.--Such organization shall 
        segregate government funds provided under such 
        substance abuse program into a separate account. Only 
        the government funds shall be subject to audit by the 
        government.
    (h) Compliance.--Any party that seeks to enforce such 
party's rights under this section may assert a civil action for 
injunctive relief exclusively in an appropriate Federal or 
State court against the entity, agency or official that 
allegedly commits such violation.
    (i) Limitations on Use of Funds for Certain Purposes.--No 
funds provided through a grant or contract to a religious 
organization to provide services under any substance abuse 
program under this title or title V shall be expended for 
sectarian worship, instruction, or proselytization.
    ( j) Effect on State and Local Funds.--If a State or local 
government contributes State or local funds to carry out any 
substance abuse program under this title or title V, the State 
or local government may segregate the State or local funds from 
the Federal funds provided to carry out the program or may 
commingle the State or local funds with the Federal funds. If 
the State or local government commingles the State or local 
funds, the provisions of this section shall apply to the 
commingled funds in the same manner, and to the same extent, as 
the provisions apply to the Federal funds.
    (k) Treatment of Intermediate Contractors.--If a 
nongovernmental organization (referred to in this subsection as 
an ``intermediate organization''), acting under a contract or 
other agreement with the Federal Government or a State or local 
government, is given the authority under the contract or 
agreement to select nongovernmental organizations to provide 
services under any substance abuse program under this title or 
title V, the intermediate organization shall have the same 
duties under this section as the government but shall retain 
all other rights of a nongovernmental organization under this 
section.

SEC. 1956. [300X-66] SERVICES FOR INDIVIDUALS WITH CO-OCCURRING 
                    DISORDERS.

    States may use funds available for treatment under sections 
1911 and 1921 to treat persons with co-occurring substance 
abuse and mental disorders as long as funds available under 
such sections are used for the purposes for which they were 
authorized by law and can be tracked for accounting purposes.

  PART C--CERTAIN PROGRAMS REGARDING MENTAL HEALTH AND SUBSTANCE ABUSE

               Subpart I--Data Infrastructure Development

SEC. 1971. [300Y] DATA INFRASTRUCTURE DEVELOPMENT.

    (a) In General.--The Secretary may make grants to, and 
enter into contracts or cooperative agreements with States for 
the purpose of developing and operating mental health or 
substance abuse data collection, analysis, and reporting 
systems with regard to performance measures including capacity, 
process, and outcomes measures.
    (b) Projects.--The Secretary shall establish criteria to 
ensure that services will be available under this section to 
States that have a fundamental basis for the collection, 
analysis, and reporting of mental health and substance abuse 
performance measures and States that do not have such basis. 
The Secretary will establish criteria for determining whether a 
State has a fundamental basis for the collection, analysis, and 
reporting of data.
    (c) Condition of Receipt of Funds.--As a condition of the 
receipt of an award under this section a State shall agree to 
collect, analyze, and report to the Secretary within 2 years of 
the date of the award on a core set of performance measures to 
be determined by the Secretary in conjunction with the States.
    (d) Matching Requirement.--
            (1) In general.--With respect to the costs of the 
        program to be carried out under subsection (a) by a 
        State, the Secretary may make an award under such 
        subsection only if the applicant agrees to make 
        available (directly or through donations from public or 
        private entities) non-Federal contributions toward such 
        costs in an amount that is not less than 50 percent of 
        such costs.
            (2) Determination of amount contributed.--Non-
        Federal contributions under paragraph (1) may be in 
        cash or in kind, fairly evaluated, including plant, 
        equipment, or services. Amounts provided by the Federal 
        Government, or services assisted or subsidized to any 
        significant extent by the Federal Government, may not 
        be included in determining the amount of such 
        contributions.
    (e) Duration of Support.--The period during which payments 
may be made for a project under subsection (a) may be not less 
than 3 years nor more than 5 years.
    (f ) Authorization of Appropriation.--
            (1) In general.--For the purpose of carrying out 
        this section, there are authorized to be appropriated 
        such sums as may be necessary for each of the fiscal 
        years 2001, 2002 and 2003.
            (2) Allocation.--Of the amounts appropriated under 
        paragraph (1) for a fiscal year, 50 percent shall be 
        expended to support data infrastructure development for 
        mental health and 50 percent shall be expended to 
        support data infrastructure development for substance 
        abuse.

   Subpart II--Interim Maintenance Treatment of Narcotics Dependence

SEC. 1976. [300Y-11] INTERIM MAINTENANCE TREATMENT.

    (a) Requirement Regarding Secretary.--Subject to the 
following subsections of this section, for the purpose of 
reducing the incidence of the transmission of HIV disease 
pursuant to the intravenous abuse of heroin or other morphine-
like drugs, the Secretary, in establishing conditions for the 
use of methadone in public or nonprofit private programs of 
treatment for dependence on such drugs, shall authorize such 
programs--
            (1) to dispense methadone for treatment purposes to 
        individuals who--
                    (A) meet the conditions for admission to 
                such programs that dispense methadone as part 
                of comprehensive treatment for such dependence; 
                and
                    (B) are seeking admission to such programs 
                that so dispense methadone, but as a result of 
                the limited capacity of the programs, will not 
                gain such admission until 14 or more days after 
                seeking admission to the programs; and
            (2) in dispensing methadone to such individuals, to 
        provide only minimum ancillary services during the 
        period in which the individuals are waiting for 
        admission to programs of comprehensive treatment.
    (b) Inapplicability of Requirement in Certain 
Circumstances.--
            (1) In general.--The requirement established in 
        subsection (a) for the Secretary does not apply if any 
        or all of the following conditions are met:
                    (A) The preponderance of scientific 
                research indicates that the risk of the 
                transmission of HIV disease pursuant to the 
                intravenous abuse of drugs is minimal.
                    (B) The preponderance of scientific 
                research indicates that the medically 
                supervised dispensing of methadone is not an 
                effective method of reducing the extent of 
                dependence on heroin and other morphine-like 
                drugs.
                    (C) The preponderance of available data 
                indicates that, of treatment programs that 
                dispense methadone as part of comprehensive 
                treatment, a substantial majority admit all 
                individuals seeking services to the programs 
                not later than 14 days after the individuals 
                seek admission to the programs.
            (2) Evaluation by secretary.--In evaluating whether 
        any or all of the conditions described in paragraph (1) 
        have been met, the Secretary shall consult with the 
        National Commission on Acquired Immune Deficiency 
        Syndrome.
    (c) Conditions for Obtaining Authorization From 
Secretary.--
            (1) In general.--In carrying out the requirement 
        established in subsection (a), the Secretary shall, 
        after consultation with the National Commission on 
        Acquired Immune Deficiency Syndrome, by regulation 
        issue such conditions for treatment programs to obtain 
        authorization from the Secretary to provide interim 
        maintenance treatment as may be necessary to carry out 
        the purpose described in such subsection. Such 
        conditions shall include conditions for preventing the 
        unauthorized use of methadone.
            (2) Counseling on hiv disease.--The regulations 
        issued under paragraph (1) shall provide that an 
        authorization described in such paragraph may not be 
        issued to a treatment program unless the program 
        provides to recipients of the treatment counseling on 
        preventing exposure to and the transmission of HIV 
        disease.
            (3) Permission of relevant state as condition of 
        authorization.--The regulations issued under paragraph 
        (1) shall provide that the Secretary may not provide an 
        authorization described in such paragraph to any 
        treatment program in a State unless the chief public 
        health officer of the State has certified to the 
        Secretary that--
                    (A) such officer does not object to the 
                provision of such authorizations to treatment 
                programs in the State; and
                    (B) the provision of interim maintenance 
                services in the State will not reduce the 
                capacity of comprehensive treatment programs in 
                the State to admit individuals to the programs 
                (relative to the date on which such officer so 
                certifies).
            (4) Date certain for issuance of regulations; 
        failure of secretary.--The Secretary shall issue the 
        final rule for purposes of the regulations required in 
        paragraph (1), and such rule shall be effective, not 
        later than the expiration of the 180-day period 
        beginning on the date of the enactment of the ADAMHA 
        Reorganization Act \1\. If the Secretary fails to meet 
        the requirement of the preceding sentence, the proposed 
        rule issued on March 2, 1989, with respect to part 291 
        of title 21, Code of Federal Regulations (docket 
        numbered 88N-0444; 54 Fed. Reg. 8973 et seq.) is deemed 
        to take effect as a final rule upon the expiration of 
        such period, and the provisions of paragraph (3) of 
        this subsection are deemed to be incorporated into such 
        rule.
---------------------------------------------------------------------------
    \1\ Enacted July 10, 1992.
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    (d) Definitions.--For purposes of this section:
            (1) The term ``interim maintenance services'' means 
        the provision of methadone in a treatment program under 
        the circumstances described in paragraphs (1) and (2) 
        of subsection (a).
            (2) The term ``HIV disease'' means infection with 
        the etiologic agent for acquired immune deficiency 
        syndrome.
            (3) The term ``treatment program'' means a public 
        or nonprofit private program of treatment for 
        dependence on heroin or other morphine-like drugs.
        TITLE XX--ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS

                         findings and purposes

    Sec. 2001. [300z] (a) The Congress finds that--
            (1) in 1978, an estimated one million one hundred 
        thousand teenagers became pregnant, more than five 
        hundred thousand teenagers carried their babies to 
        term, and over one-half of the babies born to such 
        teenagers were born out of wedlock;
            (2) adolescents aged seventeen and younger 
        accounted for more than one-half of the out of wedlock 
        births to teenagers;
            (3) in a high proportion of cases, the pregnant 
        adolescent is herself the product of an unmarried 
        parenthood during adolescence and is continuing the 
        pattern in her own lifestyle;
            (4) it is estimated that approximately 80 per 
        centum of unmarried teenagers who carry their 
        pregnancies to term live with their families before and 
        during their pregnancy and remain with their families 
        after the birth of the child;
            (5) pregnancy and childbirth among unmarried 
        adolescents, particularly young adolescents, often 
        results in severe adverse health, social, and economic 
        consequences including: a higher percentage of 
        pregnancy and childbirth complications; a higher 
        incidence of low birth weight babies; a higher infant 
        mortality and morbidity; a greater likelihood that an 
        adolescent marriage will end in divorce; a decreased 
        likelihood of completing schooling; and higher risks of 
        unemployment and welfare dependency; and therefore, 
        education, training, and job research services are 
        important for adolescent parents;
            (6)(A) adoption is a positive option for unmarried 
        pregnant adolescents who are unwilling or unable to 
        care for their children since adoption is a means of 
        providing permanent families for such children from 
        available approved couples who are unable or have 
        difficulty in conceiving or carrying children of their 
        own to term; and
            (B) at present, only 4 per centum of unmarried 
        pregnant adolescents who carry their babies to term 
        enter into an adoption plan or arrange for their babies 
        to be cared for by relatives or friends;
            (7) an unmarried adolescent who becomes pregnant 
        once is likely to experience recurrent pregnancies and 
        childbearing, with increased risks;
            (8)(A) the problems of adolescent premarital sexual 
        relations, pregnancy, and parenthood are multiple and 
        complex and are frequently associated with or are a 
        cause of other troublesome situations in the family; 
        and
            (B) such problems are best approached through a 
        variety of integrated and essential services provided 
        to adolescents and their families by other family 
        members, religious and charitable organizations, 
        voluntary associations, and other groups in the private 
        sector as well as services provided by publicly 
        sponsored initiatives;
            (9) a wide array of educational, health, and 
        supportive services are not available to adolescents 
        with such problems or to their families, or when 
        available frequently are fragmented and thus are of 
        limited effectiveness in discouraging adolescent 
        premarital sexual relations and the consequences of 
        such relations;
            (10)(A) prevention of adolescent sexual activity 
        and adolescent pregnancy depends primarily upon 
        developing strong family values and close family ties, 
        and since the family is the basic social unit in which 
        the values and attitudes of adolescents concerning 
        sexuality and pregnancy are formed, programs designed 
        to deal with issues of sexuality and pregnancy will be 
        successful to the extent that such programs encourage 
        and sustain the role of the family in dealing with 
        adolescent sexual activity and adolescent pregnancy;
            (B) Federal policy therefore should encourage the 
        development of appropriate health, educational, and 
        social services where such services are now lacking or 
        inadequate, and the better coordination of existing 
        services where they are available; and
            (C) services encouraged by the Federal Government 
        should promote the involvement of parents with their 
        adolescent children, and should emphasize the provision 
        of support by other family members, religious and 
        charitable organizations, voluntary associations, and 
        other groups in the private sector in order to help 
        adolescents and their families deal with complex issues 
        of adolescent premarital sexual relations and the 
        consequences of such relations; and
            (11)(A) there has been limited research concerning 
        the societal causes and consequences of adolescent 
        pregnancy;
            (B) there is limited knowledge concerning which 
        means of intervention are effective in mediating or 
        eliminating adolescent premarital sexual relations and 
        adolescent pregnancy; and
            (C) it is necessary to expand and strengthen such 
        knowledge in order to develop an array of approaches to 
        solving the problems of adolescent premarital sexual 
        relations and adolescent pregnancy in both urban and 
        rural settings.
    (b) Therefore, the purposes of this title are--
            (1) to find effective means, within the context of 
        the family, of reaching adolescents before they become 
        sexually active in order to maximize the guidance and 
        support available to adolescents from parents and other 
        family members, and to promote self discipline and 
        other prudent approaches to the problem of adolescent 
        premarital sexual relations, including adolescent 
        pregnancy;
            (2) to promote adoption as an alternative for 
        adolescent parents;
            (3) to establish innovative, comprehensive, and 
        integrated approaches to the delivery of care services 
        both for pregnant adolescents, with primary emphasis on 
        unmarried adolescents who are seventeen years of age or 
        under, and for adolescent parents, which shall be based 
        upon an assessment of existing programs and, where 
        appropriate, upon efforts to establish better 
        coordination, integration, and linkages among such 
        existing programs in order to--
                    (A) enable pregnant adolescents to obtain 
                proper care and assist pregnant adolescents and 
                adolescent parents to become productive 
                independent contributors to family and 
                community life; and
                    (B) assist families of adolescents to 
                understand and resolve the societal causes 
                which are associated with adolescent pregnancy;
            (4) to encourage and support research projects and 
        demonstration projects concerning the societal causes 
        and consequences of adolescent premarital sexual 
        relations, contraceptive use, pregnancy, and child 
        rearing;
            (5) to support evaluative research to identify 
        effective services which alleviate, eliminate, or 
        resolve any negative consequences of adolescent 
        premarital sexual relations and adolescent childbearing 
        for the parents, the child, and their families; and
            (6) to encourage and provide for the dissemination 
        of results, findings, and information from programs and 
        research projects relating to adolescent premarital 
        sexual relations, pregnancy, and parenthood.

                              definitions

    Sec. 2002. [300z-1] (a) For the purposes of this title, the 
term--
            (1) ``Secretary'' means the Secretary of Health and 
        Human Services;
            (2) ``eligible person'' means--
                    (A) with regard to the provision of care 
                services, a pregnant adolescent, an adolescent 
                parent, or the family of a pregnant adolescent 
                or an adolescent parent; or
                    (B) with regard to the provision of 
                prevention services and referral to such other 
                services which may be appropriate, a 
                nonpregnant adolescent;
            (3) ``eligible grant recipient'' means a public or 
        nonprofit private organization or agency which 
        demonstrates, to the satisfaction of the Secretary--
                    (A) in the case of an organization which 
                will provide care services, the capability of 
                providing all care services in a single setting 
                or the capability of creating a network through 
                which all care services would be provided; or
                    (B) in the case of an organization which 
                will provide prevention services, the 
                capability of providing such services;
            (4) ``necessary services'' means services which may 
        be provided by grantees which are--
                    (A) pregnancy testing and maternity 
                counseling;
                    (B) adoption counseling and referral 
                services which present adoption as an option 
                for pregnant adolescents, including referral to 
                licensed adoption agencies in the community if 
                the eligible grant recipient is not a licensed 
                adoption agency;
                    (C) primary and preventive health services 
                including prenatal and postnatal care;
                    (D) nutrition information and counseling;
                    (E) referral for screening and treatment of 
                venereal disease;
                    (F) referral to appropriate pediatric care;
                    (G) educational services relating to family 
                life and problems associated with adolescent 
                premarital sexual relations, including--
                            (i) information about adoption;
                            (ii) education on the 
                        responsibilities of sexuality and 
                        parenting;
                            (iii) the development of material 
                        to support the role of parents as the 
                        provider of sex education; and
                            (iv) assistance to parents, 
                        schools, youth agencies, and health 
                        providers to educate adolescents and 
                        preadolescents concerning self-
                        discipline and responsibility in human 
                        sexuality;
                    (H) appropriate educational and vocational 
                services;
                    (I) referral to licensed residential care 
                or maternity home services; and
                    (J) mental health services and referral to 
                mental health services and to other appropriate 
                physical health services;
                    (K) child care sufficient to enable the 
                adolescent parent to continue education or to 
                enter into employment;
                    (L) consumer education and homemaking;
                    (M) counseling for the immediate and 
                extended family members of the eligible person;
                    (N) transportation;
                    (O) outreach services to families of 
                adolescents to discourage sexual relations 
                among unemancipated minors;
                    (P) family planning services; and
                    (Q) such other services consistent with the 
                purposes of this title as the Secretary may 
                approve in accordance with regulations 
                promulgated by the Secretary;
            (5) ``core services'' means those services which 
        shall be provided by a grantee, as determined by the 
        Secretary by regulation;
            (6) ``supplemental services'' means those services 
        which may be provided by a grantee, as determined by 
        the Secretary by regulation;
            (7) ``care services'' means necessary services for 
        the provision of care to pregnant adolescents and 
        adolescent parents and includes all core services with 
        respect to the provision of such care prescribed by the 
        Secretary by regulation;
            (8) ``prevention services'' means necessary 
        services to prevent adolescent sexual relations, 
        including the services described in subparagraphs (A), 
        (D), (E), (G), (H), (M), (N), (O), and (Q) of paragraph 
        (4);
            (9) ``adolescent'' means an individual under the 
        age of nineteen; and
            (10) ``unemancipated minor'' means a minor who is 
        subject to the control, authority, and supervision of 
        his or her parents or guardians, as determined under 
        State law.
    (b) Until such time as the Secretary promulgates 
regulations pursuant to the second sentence of this subsection, 
the Secretary shall use the regulations promulgated under title 
VI of the Health Services and Centers Amendments of 1978 which 
were in effect on the date of enactment of this title, to 
determine which necessary services are core services for 
purposes of this title. The Secretary may promulgate 
regulations to determine which necessary services are core 
services for purposes of this title based upon an evaluation of 
and information concerning which necessary services are 
essential to carry out the purposes of this title and taking 
into account (1) factors such as whether services are to be 
provided in urban or rural areas, the ethnic groups to be 
served, and the nature of the populations to be served, and (2) 
the results of the evaluations required under section 2006(b). 
The Secretary may from time to time revise such regulations.

          authority to make grants for demonstration projects

    Sec. 2003. [300z-2] (a) The Secretary may make grants to 
further the purposes of this title to eligible grant recipients 
which have submitted an application which the Secretary finds 
meets the requirements of section 2006 for demonstration 
projects which the Secretary determines will help communities 
provide appropriate care and prevention services in easily 
accessible locations. Demonstration projects shall, as 
appropriate, provide, supplement, or improve the quality of 
such services. Demonstration projects shall use such methods as 
will strengthen the capacity of families to deal with the 
sexual behavior, pregnancy, or parenthood of adolescents and to 
make use of support systems such as other family members, 
friends, religious and charitable organizations, and voluntary 
associations.
    (b) Grants under this title for demonstration projects may 
be for the provision of--
            (1) care services;
            (2) prevention services; or
            (3) a combination of care services and prevention 
        services.

         uses of grants for demonstration projects for services

    Sec. 2004. [300z-3] (a) Except as provided in subsection 
(b), funds provided for demonstration projects for services 
under this title may be used by grantees only to--
            (1) provide to eligible persons--
                    (A) care services;
                    (B) prevention services; or
                    (C) care and prevention services (in the 
                case of a grantee who is providing a 
                combination of care and prevention services);
            (2) coordinate, integrate, and provide linkages 
        among providers of care, prevention, and other services 
        for eligible persons in furtherance of the purposes of 
        this title;
            (3) provide supplemental services where such 
        services are not adequate or not available to eligible 
        persons in the community and which are essential to the 
        care of pregnant adolescents and to the prevention of 
        adolescent premarital sexual relations and adolescent 
        pregnancy;
            (4) plan for the administration and coordination of 
        pregnancy prevention services and programs of care for 
        pregnant adolescents and adolescent parents which will 
        further the objectives of this title; and
            (5) fulfill assurances required for grant approval 
        by section 2006.
    (b)(1) No funds provided for a demonstration project for 
services under this title may be used for the provision of 
family planning services (other than counseling and referral 
services) to adolescents unless appropriate family planning 
services are not otherwise available in the community.
    (2) Any grantee who receives funds for a demonstration 
project for services under this title and who, after 
determining under paragraph (1) that appropriate family 
planning services are not otherwise available in the community, 
provides family planning services (other than counseling and 
referral services) to adolescents may only use funds provided 
under this title for such family planning services if all funds 
received by such grantee from all other sources to support such 
family planning services are insufficient to support such 
family planning services.
    (c) Grantees who receive funds for a demonstration project 
for services under this title shall charge fees for services 
pursuant to a fee schedule approved by the Secretary as a part 
of the application described in section 2006 which bases fees 
charged by the grantee on the income of the eligible person or 
the parents or legal guardians of the eligible person and takes 
into account the difficulty adolescents face in obtaining 
resources to pay for services. A grantee who receives funds for 
a demonstration project for services under this title may not, 
in any case, discriminate with regard to the provision of 
services to any individual because of that individual's 
inability to provide payment for such services, except that in 
determining the ability of an unemancipated minor to provide 
payment for services, the income of the family of an 
unemancipated minor shall be considered in determining the 
ability of such minor to make such payments unless the parents 
or guardians of the unemancipated minor refuse to make such 
payments.

priorities, amounts, and duration of grants for demonstration projects 
                              for services

    Sec. 2005. [300z-4] (a) In approving applications for 
grants for demonstration projects for services under this 
title, the Secretary shall give priority to applicants who--
            (1) serve an area where there is a high incidence 
        of adolescent pregnancy;
            (2) serve an area with a high proportion of low-
        income families and where the availability of programs 
        of care for pregnant adolescents and adolescent parents 
        is low;
            (3) show evidence--
                    (A) in the case of an applicant who will 
                provide care services, of having the ability to 
                bring together a wide range of needed core 
                services and, as appropriate, supplemental 
                services in comprehensive single-site projects, 
                or to establish a well-integrated network of 
                such services (appropriate for the target 
                population and geographic area to be served 
                including the special needs of rural areas) for 
                pregnant adolescents or adolescent parents; or
                    (B) in the case of an applicant who will 
                provide prevention services, of having the 
                ability to provide prevention services for 
                adolescents and their families which are 
                appropriate for the target population and the 
                geographic area to be served, including the 
                special needs of rural areas;
            (4) will utilize to the maximum extent feasible 
        existing available programs and facilities such as 
        neighborhood and primary health care centers, maternity 
        homes which provide or can be equipped to provide 
        services to pregnant adolescents, agencies serving 
        families, youth, and children with established programs 
        of service to pregnant adolescents and vulnerable 
        families, licensed adoption agencies, children and 
        youth centers, maternal and infant health centers, 
        regional rural health facilities, school and other 
        educational programs, mental health programs, nutrition 
        programs, recreation programs, and other ongoing 
        pregnancy prevention services and programs of care for 
        pregnant adolescents and adolescent parents;
            (5) make use, to the maximum extent feasible, of 
        other Federal, State, and local funds, programs, 
        contributions, and other third-party reimbursements;
            (6) can demonstrate a community commitment to the 
        program by making available to the demonstration 
        project non-Federal funds, personnel, and facilities;
            (7) have involved the community to be served, 
        including public and private agencies, adolescents, and 
        families, in the planning and implementation of the 
        demonstration project; and
            (8) will demonstrate innovative and effective 
        approaches in addressing the problems of adolescent 
        premarital sexual relations, pregnancy, or parenthood, 
        including approaches to provide pregnant adolescents 
        with adequate information about adoption.
    (b)(1) The amount of a grant for a demonstration project 
for services under this title shall be determined by the 
Secretary, based on factors such as the incidence of adolescent 
pregnancy in the geographic area to be served, and the adequacy 
of pregnancy prevention services and programs of care for 
pregnant adolescents and adolescent parents in such area.
    (2) In making grants for demonstration projects for 
services under this title, the Secretary shall consider the 
special needs of rural areas and, to the maximum extent 
practicable, shall distribute funds taking into consideration 
the relative number of adolescents in such areas in need of 
such services.
    (c)(1) A grantee may not receive funds for a demonstration 
project for services under this title for a period in excess of 
5 years.
    (2)(A) Subject to paragraph (3), a grant for a 
demonstration project for services under this title may not 
exceed--
            (i) 70 per centum of the costs of the project for 
        the first and second years of the project;
            (ii) 60 per centum of such costs for the third year 
        of the project;
            (iii) 50 per centum of such costs for the fourth 
        year of the project; and
            (iv) 40 per centum of such costs for the fifth year 
        of the project.
    (B) Non-Federal contributions required by subparagraph (A) 
may be in cash or in kind, fairly evaluated, including plant, 
equipment, or services.
    (3) The Secretary may waive the limitation specified in 
paragraph (2)(A) for any year in accordance with criteria 
established by regulation.

                     requirements for applications

    Sec. 2006. [300z-5] (a) An application for a grant for a 
demonstration project for services under this title shall be in 
such form and contain such information as the Secretary may 
require, and shall include--
            (1) an identification of the incidence of 
        adolescent pregnancy and related problems;
            (2) a description of the economic conditions and 
        income levels in the geographic area to be served;
            (3) a description of existing pregnancy prevention 
        services and programs of care for pregnant adolescents 
        and adolescent parents (including adoption services), 
        and including where, how, by whom, and to which 
        population groups such services are provided, and the 
        extent to which they are coordinated in the geographic 
        area to be served;
            (4) a description of the major unmet needs for 
        services for adolescents at risk of initial or 
        recurrent pregnancies and an estimate of the number of 
        adolescents not being served in the area;
            (5)(A) in the case of an applicant who will provide 
        care services, a description of how all core services 
        will be provided in the demonstration project using 
        funds under this title or will otherwise be provided by 
        the grantee in the area to be served, the population to 
        which such services will be provided, how such services 
        will be coordinated, integrated, and linked with other 
        related programs and services and the source or sources 
        of funding of such core services in the public and 
        private sectors; or
            (B) in the case of an applicant who will provide 
        prevention services, a description of the necessary 
        services to be provided and how the applicant will 
        provide such services;
            (6) a description of the manner in which 
        adolescents needing services other than the services 
        provided directly by the applicant will be identified 
        and how access and appropriate referral to such other 
        services (such as medicaid; licensed adoption agencies; 
        maternity home services; public assistance; employment 
        services; child care services for adolescent parents; 
        and other city, county, and State programs related to 
        adolescent pregnancy) will be provided, including a 
        description of a plan to coordinate such other services 
        with the services supported under this title;
            (7) a description of the applicant's capacity to 
        continue services as Federal funds decrease and in the 
        absence of Federal assistance;
            (8) a description of the results expected from the 
        provision of services, and the procedures to be used 
        for evaluating those results;
            (9) a summary of the views of public agencies, 
        providers of services, and the general public in the 
        geographic area to be served, concerning the proposed 
        use of funds provided for a demonstration project for 
        services under this title and a description of 
        procedures used to obtain those views, and, in the case 
        of applicants who propose to coordinate services 
        administered by a State, the written comments of the 
        appropriate State officials responsible for such 
        services;
            (10) assurances that the applicant will have an 
        ongoing quality assurance program;
            (11) assurances that, where appropriate, the 
        applicant shall have a system for maintaining the 
        confidentiality of patient records in accordance with 
        regulations promulgated by the Secretary;
            (12) assurances that the applicant will demonstrate 
        its financial responsibility by the use of such 
        accounting procedures and other requirements as may be 
        prescribed by the Secretary;
            (13) assurances that the applicant (A) has or will 
        have a contractual or other arrangement with the agency 
        of the State (in which the applicant provides services) 
        that administers or supervises the administration of a 
        State plan approved under title XIX of the Social 
        Security Act for the payment of all or a part of the 
        applicant's costs in providing health services to 
        persons who are eligible for medical assistance under 
        such a State plan, or (B) has made or will make every 
        reasonable effort to enter into such an arrangement;
            (14) assurances that the applicant has made or will 
        make and will continue to make every reasonable effort 
        to collect appropriate reimbursement for its costs in 
        providing health services to persons who are entitled 
        to benefits under title V of the Social Security Act, 
        to medical assistance under a State plan approved under 
        title XIX of such Act, or to assistance for medical 
        expenses under any other public assistance program or 
        private health insurance program;
            (15) assurances that the applicant has or will make 
        and will continue to make every reasonable effort to 
        collect appropriate reimbursement for its costs in 
        providing services to persons entitled to services 
        under parts B and E of title IV and title XX of the 
        Social Security Act;
            (16)(A) a description of--
                    (i) the schedule of fees to be used in the 
                provision of services, which shall comply with 
                section 2004(c) and which shall be designed to 
                cover all reasonable direct and indirect costs 
                incurred by the applicant in providing 
                services; and
                    (ii) a corresponding schedule of discounts 
                to be applied to the payment of such fees, 
                which shall comply with section 2004(c) and 
                which shall be adjusted on the basis of the 
                ability of the eligible person to pay;
            (B) assurances that the applicant has made and will 
        continue to make every reasonable effort--
                    (i) to secure from eligible persons payment 
                for services in accordance with such schedules;
                    (ii) to collect reimbursement for health or 
                other services provided to persons who are 
                entitled to have payment made on their behalf 
                for such services under any Federal or other 
                government program or private insurance 
                program; and
                    (iii) to seek such reimbursement on the 
                basis of the full amount of fees for services 
                without application of any discount; and
            (C) assurances that the applicant has submitted or 
        will submit to the Secretary such reports as the 
        Secretary may require to determine compliance with this 
        paragraph;
            (17) assurances that the applicant will make 
        maximum use of funds available under title X of this 
        Act;
            (18) assurances that the acceptance by any 
        individual of family planning services or family 
        planning information (including educational materials) 
        provided through financial assistance under this title 
        shall be voluntary and shall not be a prerequisite to 
        eligibility for or receipt of any other service 
        furnished by the applicant;
            (19) assurances that fees collected by the 
        applicant for services rendered in accordance with this 
        title shall be used by the applicant to further the 
        purposes of this title;
            (20) assurances that the applicant, if providing 
        both prevention and care services will not exclude or 
        discriminate against any adolescent who receives 
        prevention services and subsequently requires care 
        services as a pregnant adolescent;
            (21) a description of how the applicant will, as 
        appropriate in the provision of services--
                    (A) involve families of adolescents in a 
                manner which will maximize the role of the 
                family in the solution of problems relating to 
                the parenthood or pregnancy of the adolescent;
                    (B) involve religious and charitable 
                organizations, voluntary associations, and 
                other groups in the private sector as well as 
                services provided by publicly sponsored 
                initiatives;
            (22)(A) assurances that--
                    (i) except as provided in subparagraph (B) 
                and subject to clause (ii), the applicant will 
                notify the parents or guardians of any 
                unemancipated minor requesting services from 
                the applicant and, except as provided in 
                subparagraph (C), will obtain the permission of 
                such parents or guardians with respect to the 
                provision of such services; and
                    (ii) in the case of a pregnant 
                unemancipated minor requesting services from 
                the applicant, the applicant will notify the 
                parents or guardians of such minor under clause 
                (i) within a reasonable period of time;
            (B) assurances that the applicant will not notify 
        or request the permission of the parents or guardian of 
        any unemancipated minor without the consent of the 
        minor--
                    (i) who solely is requesting from the 
                applicant pregnancy testing or testing or 
                treatment for venereal disease;
                    (ii) who is the victim of incest involving 
                a parent; or
                    (iii) if an adult sibling of the minor or 
                an adult aunt, uncle, or grandparent who is 
                related to the minor by blood certifies to the 
                grantee that notification of the parents or 
                guardians of such minor would result in 
                physical injury to such minor; and
            (C) assurances that the applicant will not require, 
        with respect to the provision of services, the 
        permission of the parents or guardians of any pregnant 
        unemancipated minor if such parents or guardians are 
        attempting to compel such minor to have an abortion;
            (23) assurances that primary emphasis for services 
        supported under this title shall be given to 
        adolescents seventeen and under who are not able to 
        obtain needed assistance through other means;
            (24) assurances that funds received under this 
        title shall supplement and not supplant funds received 
        from any other Federal, State, or local program or any 
        private sources of funds; and
            (25) a plan for the conduct of, and assurances that 
        the applicant will conduct, evaluations of the 
        effectiveness of the services supported under this 
        title in accordance with subsection (b).
    (b)(1) Each grantee which receives funds for a 
demonstration project for services under this title shall 
expend at least 1 per centum but not in excess of 5 per centum 
of the amounts received under this title for the conduct of 
evaluations of the services supported under this title. The 
Secretary may, for a particular grantee upon good cause shown, 
waive the provisions of the preceding sentence with respect to 
the amounts to be expended on evaluations, but may not waive 
the requirement that such evaluations be conducted.
    (2) Evaluations required by paragraph (1) shall be 
conducted by an organization or entity which is independent of 
the grantee providing services supported under this title. To 
assist in conducting the evaluations required by paragraph (1), 
each grantee shall develop a working relationship with a 
college or university located in the grantee's State which will 
provide or assist in providing monitoring and evaluation of 
services supported under this title unless no college or 
university in the grantee's State is willing or has the 
capacity to provide or assist in providing such monitoring and 
assistance.
    (3) The Secretary may provide technical assistance with 
respect to the conduct of evaluations required under this 
subsection to any grantee which is unable to develop a working 
relationship with a college or university in the applicant's 
State for the reasons described in paragraph (2).
    (c) Each grantee which receives funds for a demonstration 
project for services under this title shall make such reports 
concerning its use of Federal funds as the Secretary may 
require. Reports shall include, at such times as are considered 
appropriate by the Secretary, the results of the evaluations of 
the services supported under this title.
    (d)(1) A grantee shall periodically notify the Secretary of 
the exact number of instances in which a grantee does not 
notify the parents or guardians of a pregnant unemancipated 
minor under subsection (a)(22)(B)(iii).
    (2) For purposes of subsection (a)(22)(B)(iii), the term 
``adult'' means an adult as defined by State law.
    (e) Each applicant shall provide the Governor of the State 
in which the applicant is located a copy of each application 
submitted to the Secretary for a grant for a demonstration 
project for services under this title. The Governor shall 
submit to the applicant comments on any such application within 
the period of sixty days beginning on the day when the Governor 
receives such copy. The applicant shall include the comments of 
the Governor with such application.
    (f) No application submitted for a grant for a 
demonstration project for care services under this title may be 
approved unless the Secretary is satisfied that core services 
shall be available through the applicant within a reasonable 
time after such grant is received.

               coordination of federal and state programs

    Sec. 2007. [300z-6] (a) The Secretary shall coordinate 
Federal policies and programs providing services relating to 
the prevention of adolescent sexual relations and initial and 
recurrent adolescent pregnancies and providing care services 
for pregnant adolescents. In achieving such coordination, the 
Secretary shall--
            (1) require grantees who receive funds for 
        demonstration projects for services under this title to 
        report periodically to the Secretary concerning 
        Federal, State, and local policies and programs that 
        interfere with the delivery of and coordination of 
        pregnancy prevention services and other programs of 
        care for pregnant adolescents and adolescent parents;
            (2) provide technical assistance to facilitate 
        coordination by State and local recipients of Federal 
        assistance;
            (3) review all programs administered by the 
        Department of Health and Human Services which provide 
        prevention services or care services to determine if 
        the policies of such programs are consistent with the 
        policies of this title, consult with other departments 
        and agencies of the Federal Government who administer 
        programs that provide such services, and encourage such 
        other departments and agencies to make recommendations, 
        as appropriate, for legislation to modify such programs 
        in order to facilitate the use of all Government 
        programs which provide such services as a basis for 
        delivery of more comprehensive prevention services and 
        more comprehensive programs of care for pregnant 
        adolescents and adolescent parents;
            (4) give priority in the provision of funds, where 
        appropriate, to applicants using single or coordinated 
        grant applications for multiple programs; and
            (5) give priority, where appropriate, to the 
        provision of funds under Federal programs administered 
        by the Secretary (other than the program established by 
        this title) to projects providing comprehensive 
        prevention services and comprehensive programs of care 
        for pregnant adolescents and adolescent parents.
    (b) Any recipient of a grant for a demonstration project 
for services under this title shall coordinate its activities 
with any other recipient of such a grant which is located in 
the same locality.

                                research

    Sec. 2008. [300z-7] (a)(1) The Secretary may make grants 
and enter into contracts with public agencies or private 
organizations or institutions of higher education to support 
the research and dissemination activities described in 
paragraphs (4), (5), and (6) of section 2001(b).
    (2) The Secretary may make grants or enter into contracts 
under this section for a period of one year. A grant or 
contract under this section for a project may be renewed for 
four additional one-year periods, which need not be 
consecutive.
    (3) A grant or contract for any one-year period under this 
section may not exceed $100,000 for the direct costs of 
conducting research or disemination \1\ activities under this 
section and may include such additional amounts for the 
indirect costs of conducting such activities as the Secretary 
determines appropriate. The Secretary may waive the preceding 
sentence with respect to a specific project if he determines 
that--
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    \1\ So in law. Probably should be ``dissemination''.
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            (A) exceptional circumstances warrant such waiver 
        and that the project will have national impact; or
            (B) additional amounts are necessary for the direct 
        costs of conducting limited demonstration projects for 
        the provision of necessary services in order to provide 
        data for research carried out under this title.
    (4) The amount of any grant or contract made under this 
section may remain available for obligation or expenditure 
after the close of the one-year period for which such grant or 
contract is made in order to assist the recipient in preparing 
the report required by subsection (f)(1).
    (b)(1) Funds provided for research under this section may 
be used for descriptive or explanatory surveys, longitudinal 
studies, or limited demonstration projects for services that 
are for the purpose of increasing knowledge and understanding 
of the matters described in paragraphs (4) and (5) of section 
2001(b).
    (2) Funds provided under this section may not be used for 
the purchase or improvement of land, or the purchase, 
construction, or permanent improvement (other than minor 
remodeling) of any building or facility.
    (c) The Secretary may not make any grant or enter into any 
contract to support research or dissemination activities under 
this section unless--
            (1) the Secretary has received an application for 
        such grant or contract which is in such form and which 
        contains such information as the Secretary may by 
        regulation require;
            (2) the applicant has demonstrated that the 
        applicant is capable of conducting one or more of the 
        types of research or dissemination activities described 
        in paragraph (4), (5), or (6) of section 2001(b); and
            (3) in the case of an application for a research 
        project, the panel established by subsection (e)(2) has 
        determined that the project is of scientific merit.
    (d) The Secretary shall, where appropriate, coordinate 
research and dissemination activities carried out under this 
section with research and dissemination activities carried out 
by the National Institutes of Health.
    (e)(1) The Secretary shall establish a system for the 
review of applications for grants and contracts under this 
section. Such system shall be substantially similar to the 
system for scientific peer review of the National Institutes of 
Health and shall meet the requirements of paragraphs (2) and 
(3).
    (2) In establishing the system required by paragraph (1), 
the Secretary shall establish a panel to review applications 
under this section. Not more than 25 per centum of the members 
of the panel shall be physicians. The panel shall meet as often 
as may be necessary to facilitate the expeditious review of 
applications under this section, but not less than once each 
year. The panel shall review each project for which an 
application is made under this section, evaluate the scientific 
merit of the project, determine whether the project is of 
scientific merit, and make recommendations to the Secretary 
concerning whether the application for the project should be 
approved.
    (3) The Secretary shall make grants under this section from 
among the projects which the panel established by paragraph (2) 
has determined to be of scientific merit and may only approve 
an application for a project if the panel has made such 
determination with respect to such a project. The Secretary 
shall make a determination with respect to an application 
within one month after receiving the determinations and 
recommendations of such panel with respect to the application.
    (f)(1)(A) The recipient of a grant or contract for a 
research project under this section shall prepare and transmit 
to the Secretary a report describing the results and 
conclusions of such research. Except as provided in 
subparagraph (B), such report shall be transmitted to the 
Secretary not later than eighteen months after the end of the 
year for which funds are provided under this section. The 
recipient may utilize reprints of articles published or 
accepted for publication in professional journals to supplement 
or replace such report if the research contained in such 
articles was supported under this section during the year for 
which the report is required.
    (B) In the case of any research project for which 
assistance is provided under this section for two or more 
consecutive one-year periods, the recipient of such assistance 
shall prepare and transmit the report required by subparagraph 
(A) to the Secretary not later than twelve months after the end 
of each one-year period for which such funding is provided.
    (2) Recipients of grants and contracts for dissemination 
under this section shall submit to the Secretary such reports 
as the Secretary determines appropriate.

                     evaluation and administration

    Sec. 2009. [300z-8] (a) Of the funds appropriated under 
this title, the Secretary shall reserve not less than 1 per 
centum and not more than 3 per centum for the evaluation of 
activities carried out under this title. The Secretary shall 
submit to the appropriate committees of the Congress a summary 
of each evaluation conducted under this section.
    (b) The officer or employee of the Department of Health and 
Human Services designated by the Secretary to carry out the 
provisions of this title shall report directly to the Assistant 
Secretary for Health with respect to the activities of such 
officer or employee in carrying out such provisions.

                    authorization of appropriations

    Sec. 2010. [300z-9] (a) For the purpose of carrying out 
this title, there are authorized to be appropriated $30,000,000 
for the fiscal year ending September 30, 1982, $30,000,000 for 
the fiscal year ending September 30, 1983, $30,000,000 for the 
fiscal year ending September 30, 1984, and $30,000,000 for the 
fiscal year ending September 30, 1985.
    (b) At least two-thirds of the amounts appropriated to 
carry out this title shall be used to make grants for 
demonstration projects for services.
    (c) Not more than one-third of the amounts specified under 
subsection (b) for use for grants for demonstration projects 
for services shall be used for grants for demonstration 
projects for prevention services.

                              restrictions

    Sec. 2011. [300z-10] (a) Grants or payments may be made 
only to programs or projects which do not provide abortions or 
abortion counseling or referral, or which do not subcontract 
with or make any payment to any person who provides abortions 
or abortion counseling or referral, except that any such 
program or project may provide referral for abortion counseling 
to a pregnant adolescent if such adolescent and the parents or 
guardians of such adolescent request such referral; and grants 
may be made only to projects or programs which do not advocate, 
promote, or encourage abortion.
    (b) The Secretary shall ascertain whether programs or 
projects comply with subsection (a) and take appropriate action 
if programs or projects do not comply with such subsection, 
including withholding of funds.ATTORNEY: PMG/FD (June 
22, 1999) deg.
                          TITLE XXI--VACCINES

                  Subtitle 1--National Vaccine Program

                             establishment
    Sec. 2101. [300aa-1] The Secretary shall establish in the 
Department of Health and Human Services a National Vaccine 
Program to achieve optimal prevention of human infectious 
diseases through immunization and to achieve optimal prevention 
against adverse reactions to vaccines. The Program shall be 
administered by a Director selected by the Secretary.
                        program responsibilities
    Sec. 2102. [300aa-2] (a) The Director of the Program shall 
have the following responsibilities:
            (1) Vaccine research.--The Director of the Program 
        shall, through the plan issued under section 2103, 
        coordinate and provide direction for research carried 
        out in or through the National Institutes of Health, 
        the Centers for Disease Control and Prevention, the 
        Office of Biologics Research and Review of the Food and 
        Drug Administration, the Department of Defense, and the 
        Agency for International Development on means to induce 
        human immunity against naturally occurring infectious 
        diseases and to prevent adverse reactions to vaccines.
            (2) Vaccine development.--The Director of the 
        Program shall, through the plan issued under section 
        2103, coordinate and provide direction for activities 
        carried out in or through the National Institutes of 
        Health, the Office of Biologics Research and Review of 
        the Food and Drug Administration, the Department of 
        Defense, and the Agency for International Development 
        to develop the techniques needed to produce safe and 
        effective vaccines.
            (3) Safety and efficacy testing of vaccines.--The 
        Director of the Program shall, through the plan issued 
        under section 2103, coordinate and provide direction 
        for safety and efficacy testing of vaccines carried out 
        in or through the National Institutes of Health, the 
        Centers for Disease Control and Prevention, the Office 
        of Biologics Research and Review of the Food and Drug 
        Administration, the Department of Defense, and the 
        Agency for International Development.
            (4) Licensing of vaccine manufacturers and 
        vaccines.--The Director of the Program shall, through 
        the plan issued under section 2103, coordinate and 
        provide direction for the allocation of resources in 
        the implementation of the licensing program under 
        section 353.
            (5) Production and procurement of vaccines.--The 
        Director of the Program shall, through the plan issued 
        under section 2103, ensure that the governmental and 
        non-governmental production and procurement of safe and 
        effective vaccines by the Public Health Service, the 
        Department of Defense, and the Agency for International 
        Development meet the needs of the United States 
        population and fulfill commitments of the United States 
        to prevent human infectious diseases in other 
        countries.
            (6) Distribution and use of vaccines.--The Director 
        of the Program shall, through the plan issued under 
        section 2103, coordinate and provide direction to the 
        Centers for Disease Control and Prevention and 
        assistance to States, localities, and health 
        practitioners in the distribution and use of vaccines, 
        including efforts to encourage public acceptance of 
        immunizations and to make health practitioners and the 
        public aware of potential adverse reactions and 
        contraindications to vaccines.
            (7) Evaluating the need for and the effectiveness 
        and adverse effects of vaccines and immunization 
        activities.--The Director of the Program shall, through 
        the plan issued under section 2103, coordinate and 
        provide direction to the National Institutes of Health, 
        the Centers for Disease Control and Prevention, the 
        Office of Biologics Research and Review of the Food and 
        Drug Administration, the National Center for Health 
        Statistics, the National Center for Health Services 
        Research and Health Care Technology Assessment, and the 
        Centers for Medicare & Medicaid Services in monitoring 
        the need for and the effectiveness and adverse effects 
        of vaccines and immunization activities.
            (8) Coordinating governmental and non-governmental 
        activities.--The Director of the Program shall, through 
        the plan issued under section 2103, provide for the 
        exchange of information between Federal agencies 
        involved in the implementation of the Program and non-
        governmental entities engaged in the development and 
        production of vaccines and in vaccine research and 
        encourage the investment of non-governmental resources 
        complementary to the governmental activities under the 
        Program.
            (9) Funding of federal agencies.--The Director of 
        the Program shall make available to Federal agencies 
        involved in the implementation of the plan issued under 
        section 2103 funds appropriated under section 2106 to 
        supplement the funds otherwise available to such 
        agencies for activities under the plan.
    (b) In carrying out subsection (a) and in preparing the 
plan under section 2103, the Director shall consult with all 
Federal agencies involved in research on and development, 
testing, licensing, production, procurement, distribution, and 
use of vaccines.
                                  plan
    Sec. 2103. [300aa-3] The Director of the Program shall 
prepare and issue a plan for the implementation of the 
responsibilities of the Director under section 2102. The plan 
shall establish priorities in research and the development, 
testing, licensing, production, procurement, distribution, and 
effective use of vaccines, describe an optimal use of resources 
to carry out such priorities, and describe how each of the 
various departments and agencies will carry out their vaccine 
functions in consultation and coordination with the Program and 
in conformity with such priorities. The first plan under this 
section shall be prepared not later than January 1, 1987, and 
shall be revised not later than January 1 of each succeeding 
year.
                  national vaccine advisory committee
    Sec. 2105. \1\ [300aa-5] (a) There is established the 
National Vaccine Advisory Committee. The members of the 
Committee shall be appointed by the Director of the Program, in 
consultation with the National Academy of Sciences, from among 
individuals who are engaged in vaccine research or the 
manufacture of vaccines or who are physicians, members of 
parent organizations concerned with immunizations, or 
representatives of State or local health agencies or public 
health organizations.
    (b) The Committee shall--
            (1) study and recommend ways to encourage the 
        availability of an adequate supply of safe and 
        effective vaccination products in the States,
            (2) recommend research priorities and other 
        measures the Director of the Program should take to 
        enhance the safety and efficacy of vaccines,
            (3) advise the Director of the Program in the 
        implementation of sections 2102, 2103, and 2104 \1\, 
        and
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    \1\ Section 2104 was repealed by section 601(a)(1)(H) of Public Law 
105-362.
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            (4) identify annually for the Director of the 
        Program the most important areas of government and non-
        government cooperation that should be considered in 
        implementing sections 2102, 2103, and 2104 \1\.
                             authorizations
    Sec. 2106. [300aa-6] (a) To carry out this subtitle other 
than section 2102(9) there are authorized to be appropriated 
such sums as may be necessary for each of the fiscal years 2004 
and 2005.
    (b) To carry out section 2102(9) there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2004 and 2005.

        Subtitle 2--National Vaccine Injury Compensation Program

                      Part A--Program Requirements

                        establishment of program
    Sec. 2110. [300aa-10] (a) Program Established.--There is 
established the National Vaccine Injury Compensation Program to 
be administered by the Secretary under which compensation may 
be paid for a vaccine-related injury or death.
    (b) Attorney's Obligation.--It shall be the ethical 
obligation of any attorney who is consulted by an individual 
with respect to a vaccine-related injury or death to advise 
such individual that compensation may be available under the 
program for such injury or death.
    (c) Publicity.--The Secretary shall undertake reasonable 
efforts to inform the public of the availability of the 
Program.
                       petitions for compensation
    Sec. 2111. [300aa-11] (a) General Rule.--
            (1) A proceeding for compensation under the Program 
        for a vaccine-related injury or death shall be 
        initiated by service upon the Secretary and the filing 
        of a petition containing the matter prescribed by 
        subsection (c) with the United States Claims Court. The 
        clerk of the United States Claims Court shall 
        immediately forward the filed petition to the chief 
        special master for assignment to a special master under 
        section 2112(d)(1).
            (2)(A) No person may bring a civil action for 
        damages in an amount greater than $1,000 or in an 
        unspecified amount against a vaccine administrator or 
        manufacturer in a State or Federal court for damages 
        arising from a vaccine-related injury or death 
        associated with the administration of a vaccine after 
        the effective date of this part, and no such court may 
        award damages in an amount greater than $1,000 in a 
        civil action for damages for such a vaccine-related 
        injury or death,
        unless a petition has been filed, in accordance with 
        section 2116, for compensation under the Program for 
        such injury or death and--
                    (i)(I) the United States Claims Court has 
                issued a judgment under section 2112 on such 
                petition, and
            (II) such person elects under section 2121(a) to 
        file such an action, or
                    (ii) such person elects to withdraw such 
                petition under section 2121(b) or such petition 
                is considered withdrawn under such section.
            (B) If a civil action which is barred under 
        subparagraph (A) is filed in a State or Federal court, 
        the court shall dismiss the action. If a petition is 
        filed under this section with respect to the injury or 
        death for which such civil action was brought, the date 
        such dismissed action was filed shall, for purposes of 
        the limitations of actions prescribed by section 2116, 
        be considered the date the petition was filed if the 
        petition was filed within one year of the date of the 
        dismissal of the civil action.
            (3) No vaccine administrator or manufacturer may be 
        made a party to a civil action (other than a civil 
        action which may be brought under paragraph (2)) for 
        damages for a vaccine-related injury or death 
        associated with the administration of a vaccine after 
        the effective date of this part. \1\
            (4) If in a civil action brought against a vaccine 
        administrator or manufacturer before the effective date 
        of this part \1\ damages were denied for a vaccine-
        related injury or death or if such civil action was 
        dismissed with prejudice, the person who brought such 
        action may file a petition under subsection (b) for 
        such injury or death.
            (5)(A) A plaintiff who on the effective date of 
        this part \1\ has pending a civil action for damages 
        for a vaccine-related injury or death may, at any time 
        within 2 years after the effective date of this part 
        \1\ or before judgment, whichever occurs first, 
        petition to have such action dismissed without 
        prejudice or costs and file a petition under subsection 
        (b) for such injury or death.
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    \1\ Effective October 1, 1988.
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            (B) If a plaintiff has pending a civil action for 
        damages for a vaccine-related injury or death, such 
        person may not file a petition under subsection (b) for 
        such injury or death.
            (6) If a person brings a civil action after 
        November 15, 1988 \2\ for damages for a vaccine-related 
        injury or death associated with the administration of a 
        vaccine before November 15, 1988, such person may not 
        file a petition under subsection (b) for such injury or 
        death.
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    \2\ So in law. Probably should be followed by a comma.
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            (7) If in a civil action brought against a vaccine 
        administrator or manufacturer for a vaccine-related 
        injury or death damages are awarded under a judgment of 
        a court or a settlement of such action, the person who 
        brought such action may not file a petition under 
        subsection (b) for such injury or death.
            (8) If on the effective date of this part there was 
        pending an appeal or rehearing with respect to a civil 
        action brought against a vaccine administrator or 
        manufacturer and if the outcome of the last appellate 
        review of such action or the last rehearing of such 
        action is the denial of damages for a vaccine-related 
        injury or death, the person who brought such action may 
        file a petition under subsection (b) for such injury or 
        death.
            (9) This subsection applies only to a person who 
        has sustained a vaccine-related injury or death and who 
        is qualified to file a petition for compensation under 
        the Program.
            (10) The Clerk of the United States Claims Court is 
        authorized to continue to receive, and forward, 
        petitions for compensation for a vaccine-related injury 
        or death associated with the administration of a 
        vaccine on or after October 1, 1992.
    (b) Petitioners.--
            (1)(A) Except as provided in subparagraph (B), any 
        person who has sustained a vaccine-related injury, the 
        legal representative of such person if such person is a 
        minor or is disabled, or the legal representative of 
        any person who died as the result of the administration 
        of a vaccine set forth in the Vaccine Injury Table may, 
        if the person meets the requirements of subsection 
        (c)(1), file a petition for compensation under the 
        Program.
            (B) No person may file a petition for a vaccine-
        related injury or death associated with a vaccine 
        administered before the effective date of this part if 
        compensation has been paid under this subtitle for 3500 
        petitions for such injuries or deaths.
            (2) Only one petition may be filed with respect to 
        each administration of a vaccine.
    (c) Petition Content.--A petition for compensation under 
the Program for a vaccine-related injury or death shall 
contain--
            (1) except as provided in paragraph (3), an 
        affidavit, and supporting documentation, demonstrating 
        that the person who suffered such injury or who died--
                    (A) received a vaccine set forth in the 
                Vaccine Injury Table or, if such person did not 
                receive such a vaccine, contracted polio, 
                directly or indirectly, from another person who 
                received an oral polio vaccine,
                    (B)(i) if such person received a vaccine 
                set forth in the Vaccine Injury Table--
                            (I) received the vaccine in the 
                        United States or in its trust 
                        territories,
                            (II) received the vaccine outside 
                        the United States or a trust territory 
                        and at the time of the vaccination such 
                        person was a citizen of the United 
                        States serving abroad as a member of 
                        the Armed Forces or otherwise as an 
                        employee of the United States or a 
                        dependent of such a citizen, or
                            (III) received the vaccine outside 
                        the United States or a trust territory 
                        and the vaccine was manufactured by a 
                        vaccine manufacturer located in the 
                        United States and such person returned 
                        to the United States not later than 6 
                        months after the date of the 
                        vaccination,
                    (ii) if such person did not receive such a 
                vaccine but contracted polio from another 
                person who received an oral polio vaccine, was 
                a citizen of the United States or a dependent 
                of such a citizen,
                    (C)(i) sustained, or had significantly 
                aggravated, any illness, disability, injury, or 
                condition set forth in the Vaccine Injury Table 
                in association with the vaccine referred to in 
                subparagraph (A) or died from the 
                administration of such vaccine, and the first 
                symptom or manifestation of the onset or of the 
                significant aggravation of any such illness, 
                disability, injury, or condition or the death 
                occurred within the time period after vaccine 
                administration set forth in the Vaccine Injury 
                Table, or
                    (ii)(I) sustained, or had significantly 
                aggravated, any illness, disability, injury, or 
                condition not set forth in the Vaccine Injury 
                Table but which was caused by a vaccine 
                referred to in subparagraph (A), or
                    (II) sustained, or had significantly 
                aggravated, any illness, disability, injury, or 
                condition set forth in the Vaccine Injury Table 
                the first symptom or manifestation of the onset 
                or significant aggravation of which did not 
                occur within the time period set forth in the 
                Table but which was caused by a vaccine 
                referred to in subparagraph (A),
                    (D)(i) suffered the residual effects or 
                complications of such illness, disability, 
                injury, or condition for more than 6 months 
                after the administration of the vaccine, or 
                (ii) died from the administration of the 
                vaccine, or (iii) suffered such illness, 
                disability, injury, or condition from the 
                vaccine which resulted in inpatient 
                hospitalization and surgical intervention, and
                    (E) has not previously collected an award 
                or settlement of a civil action for damages for 
                such vaccine-related injury or death,
            (2) except as provided in paragraph (3), maternal 
        prenatal and delivery records, newborn hospital records 
        (including all physicians' and nurses' notes and test 
        results), vaccination records associated with the 
        vaccine allegedly causing the injury, pre- and post-
        injury physician or clinic records (including all 
        relevant growth charts and test results), all post-
        injury inpatient and outpatient records (including all 
        provider notes, test results, and medication records), 
        if applicable, a death certificate, and if applicable, 
        autopsy results, and
            (3) an identification of any records of the type 
        described in paragraph (1) or (2) which are unavailable 
        to the petitioner and the reasons for their 
        unavailability.
    (d) Additional Information.--A petition may also include 
other available relevant medical records relating to the person 
who suffered such injury or who died from the administration of 
the vaccine.
    (e) Schedule.--The petitioner shall submit in accordance 
with a schedule set by the special master assigned to the 
petition assessments, evaluations, and prognoses and such other 
records and documents as are reasonably necessary for the 
determination of the amount of compensation to be paid to, or 
on behalf of, the person who suffered such injury or who died 
from the administration of the vaccine.
                              jurisdiction
    Sec. 2112. [300aa-12] (a) General Rule.--The United States 
Claims Court and the United States Claims Court special masters 
shall, in accordance with this section, have jurisdiction over 
proceedings to determine if a petitioner under section 2111 is 
entitled to compensation under the Program and the amount of 
such compensation. The United States Claims Court may issue and 
enforce such orders as the court deems necessary to assure the 
prompt payment of any compensation awarded.
    (b) Parties.--
            (1) In all proceedings brought by the filing of a 
        petition under section 2111(b), the Secretary shall be 
        named as the respondent, shall participate, and shall 
        be represented in accordance with section 518(a) of 
        title 28, United States Code.
            (2) Within 30 days after the Secretary receives 
        service of any petition filed under section 2111 the 
        Secretary shall publish notice of such petition in the 
        Federal Register. The special master designated with 
        respect to such petition under subsection (c) shall 
        afford all interested persons an opportunity to submit 
        relevant, written information--
                    (A) relating to the existence of the 
                evidence described in section 2113(a)(1)(B), or
                    (B) relating to any allegation in a 
                petition with respect to the matters described 
                in section 2111(c)(1)(C)(ii).
    (c) United States Claims Court Special Masters.--
            (1) There is established within the United States 
        Claims Court an office of special masters which shall 
        consist of not more than 8 special masters. The judges 
        of the United States Claims Court shall appoint the 
        special masters, 1 of whom, by designation of the 
        judges of the United States Claims Court, shall serve 
        as chief special master. The appointment and 
        reappointment of the special masters shall be by the 
        concurrence of a majority of the judges of the court.
            (2) The chief special master and other special 
        masters shall be subject to removal by the judges of 
        the United States Claims Court for incompetency, 
        misconduct, or neglect of duty or for physical or 
        mental disability or for other good cause shown.
            (3) A special master's office shall be terminated 
        if the judges of the United States Claims Court 
        determine, upon advice of the chief special master, 
        that the services performed by that office are no 
        longer needed.
            (4) The appointment of any individual as a special 
        master shall be for a term of 4 years, subject to 
        termination under paragraphs (2) and (3). Individuals 
        serving as special masters upon the date of the 
        enactment of this subsection shall serve for 4 years 
        from the date of their original appointment, subject to 
        termination under paragraphs (2) and (3). The chief 
        special master in office on the date of the enactment 
        of this subsection shall continue to serve as chief 
        special master for the balance of the master's term, 
        subject to termination under paragraphs (2) and (3).
            (5) The compensation of the special masters shall 
        be determined by the judges of the United States Claims 
        Court, upon advice of the chief special master. The 
        salary of the chief special master shall be the annual 
        rate of basic pay for level IV of the Executive 
        Schedule, as prescribed by section 5315, title 5, 
        United States Code. The salaries of the other special 
        masters shall not exceed the annual rate of basic pay 
        of level V of the Executive Schedule, as prescribed by 
        section 5316, title 5, United States Code.
            (6) The chief special master shall be responsible 
        for the following:
                    (A) Administering the office of special 
                masters and their staff, providing for the 
                efficient, expeditious, and effective handling 
                of petitions, and performing such other duties 
                related to the Program as may be assigned to 
                the chief special master by a concurrence of a 
                majority of the United States Claims Courts \1\ 
                judges.
---------------------------------------------------------------------------
    \1\ So in law. Probably should be ``United States Court of Federal 
Claims''.
---------------------------------------------------------------------------
                    (B) Appointing and fixing the salary and 
                duties of such administrative staff as are 
                necessary. Such staff shall be subject to 
                removal for good cause by the chief special 
                master.
                    (C) Managing and executing all aspects of 
                budgetary and administrative affairs affecting 
                the special masters and their staff, subject to 
                the rules and regulations of the Judicial 
                Conference of the United States. The Conference 
                rules and regulations pertaining to United 
                States magistrates shall be applied to the 
                special masters.
                    (D) Coordinating with the United States 
                Claims Court the use of services, equipment, 
                personnel, information, and facilities of the 
                United States Claims Court without 
                reimbursement.
                    (E) Reporting annually to the Congress and 
                the judges of the United States Claims Court on 
                the number of petitions filed under section 
                2111 and their disposition, the dates on which 
                the vaccine-related injuries and deaths for 
                which the petitions were filed occurred, the 
                types and amounts of awards, the length of time 
                for the disposition of petitions, the cost of 
                administering the Program, and recommendations 
                for changes in the Program.
    (d) Special Masters.--
            (1) Following the receipt and filing of a petition 
        under section 2111, the clerk of the United States 
        Claims Court shall forward the petition to the chief 
        special master who shall designate a special master to 
        carry out the functions authorized by paragraph (3).
            (2) The special masters shall recommend rules to 
        the Claims Court and, taking into account such 
        recommended rules, the Claims Court shall promulgate 
        rules pursuant to section 2071 of title 28, United 
        States Code. Such rules shall--
                    (A) provide for a less-adversarial, 
                expeditious, and informal proceeding for the 
                resolution of petitions,
                    (B) include flexible and informal standards 
                of admissibility of evidence,
                    (C) include the opportunity for summary 
                judgment,
                    (D) include the opportunity for parties to 
                submit arguments and evidence on the record 
                without requiring routine use of oral 
                presentations, cross examinations, or hearings, 
                and
                    (E) provide for limitations on discovery 
                and allow the special masters to replace the 
                usual rules of discovery in civil actions in 
                the United States Claims Court.
            (3)(A) A special master to whom a petition has been 
        assigned shall issue a decision on such petition with 
        respect to whether compensation is to be provided under 
        the Program and the amount of such compensation. The 
        decision of the special master shall--
                    (i) include findings of fact and 
                conclusions of law, and
                    (ii) be issued as expeditiously as 
                practicable but not later than 240 days, 
                exclusive of suspended time under subparagraph 
                (C), after the date the petition was filed.
        The decision of the special master may be reviewed by 
        the United States Claims Court in accordance with 
        subsection (e).
            (B) In conducting a proceeding on a petition a 
        special master--
                    (i) may require such evidence as may be 
                reasonable and necessary,
                    (ii) may require the submission of such 
                information as may be reasonable and necessary,
                    (iii) may require the testimony of any 
                person and the production of any documents as 
                may be reasonable and necessary,
                    (iv) shall afford all interested persons an 
                opportunity to submit relevant written 
                information--
                            (I) relating to the existence of 
                        the evidence described in section 
                        2113(a)(1)(B), or
                            (II) relating to any allegation in 
                        a petition with respect to the matters 
                        described in section 2111(c)(1)(C)(ii), 
                        and
                    (v) may conduct such hearings as may be 
                reasonable and necessary.
        There may be no discovery in a proceeding on a petition 
        other than the discovery required by the special 
        master.
            (C) In conducting a proceeding on a petition a 
        special master shall suspend the proceedings one time 
        for 30 days on the motion of either party. After a 
        motion for suspension is granted, further motions for 
        suspension by either party may be granted by the 
        special master, if the special master determines the 
        suspension is reasonable and necessary, for an 
        aggregate period not to exceed 150 days.
            (D) If, in reviewing proceedings on petitions for 
        vaccine-related injuries or deaths associated with the 
        administration of vaccines before the effective date of 
        this part, the chief special master determines that the 
        number of filings and resultant workload place an undue 
        burden on the parties or the special master involved in 
        such proceedings, the chief special master may, in the 
        interest of justice, suspend proceedings on any 
        petition for up to 30 months (but for not more than 6 
        months at a time) in addition to the suspension time 
        under subparagraph (C).
            (4)(A) Except as provided in subparagraph (B), 
        information submitted to a special master or the court 
        in a proceeding on a petition may not be disclosed to a 
        person who is not a party to the proceeding without the 
        express written consent of the person who submitted the 
        information.
            (B) A decision of a special master or the court in 
        a proceeding shall be disclosed, except that if the 
        decision is to include information--
                    (i) which is trade secret or commercial or 
                financial information which is privileged and 
                confidential, or
                    (ii) which are medical files and similar 
                files the disclosure of which would constitute 
                a clearly unwarranted invasion of privacy,
        and if the person who submitted such information 
        objects to the inclusion of such information in the 
        decision, the decision shall be disclosed without such 
        information.
    (e) Action by the United States Claims Court.--
            (1) Upon issuance of the special master's decision, 
        the parties shall have 30 days to file with the clerk 
        of the United States Claims Court a motion to have the 
        court review the decision. If such a motion is filed, 
        the other party shall file a response with the clerk of 
        the United States Claims Court no later than 30 days 
        after the filing of such motion.
            (2) Upon the filing of a motion under paragraph (1) 
        with respect to a petition, the United States Claims 
        Court shall have jurisdiction to undertake a review of 
        the record of the proceedings and may thereafter--
                    (A) uphold the findings of fact and 
                conclusions of law of the special master and 
                sustain the special master's decision,
                    (B) set aside any findings of fact or 
                conclusion of law of the special master found 
                to be arbitrary, capricious, an abuse of 
                discretion, or otherwise not in accordance with 
                law and issue its own findings of fact and 
                conclusions of law, or
                    (C) remand the petition to the special 
                master for further action in accordance with 
                the court's direction.
        The court shall complete its action on a petition 
        within 120 days of the filing of a response under 
        paragraph (1) excluding any days the petition is before 
        a special master as a result of a remand under 
        subparagraph (C). The court may allow not more than 90 
        days for remands under subparagraph (C).
            (3) In the absence of a motion under paragraph (1) 
        respecting the special master's decision or if the 
        United States Claims Court takes the action described 
        in paragraph (2)(A) with respect to the special 
        master's decision, the clerk of the United States 
        Claims Court shall immediately enter judgment in 
        accordance with the special master's decision.
    (f) Appeals.--The findings of fact and conclusions of law 
of the United States Claims Court on a petition shall be final 
determinations of the matters involved, except that the 
Secretary or any petitioner aggrieved by the findings or 
conclusions of the court may obtain review of the judgment of 
the court in the United States court of appeals for the Federal 
Circuit upon petition filed within 60 days of the date of the 
judgment with such court of appeals within 60 days of the date 
of entry of the United States Claims Court's \1\ judgment with 
such court of appeals.
---------------------------------------------------------------------------
    \1\ So in law. Probably should be a reference to the United States 
Court of Federal Claims.
---------------------------------------------------------------------------
    (g) \2\ Notice.--If--
---------------------------------------------------------------------------
    \2\ Subsection (i)(2) of section 201 of Public Law 102-168 (105 
Stat. 1104), which was enacted on November 26, 1991, provided that the 
amendments made by subsections (d) and (f) of such section ``shall take 
effect as if the amendments had been in effect on and after October 1, 
1988''. Such subsections (d) and (f) related to actions by petitioners, 
and to annuities, respectively, and involved amendments to sections 
2112(g), 2115(f)(4), 2116(c), and 2121(b).
---------------------------------------------------------------------------
            (1) a special master fails to make a decision on a 
        petition within the 240 days prescribed by subsection 
        (d)(3)(A)(ii) (excluding (A) any period of suspension 
        under subsection (d)(3)(C) or (d)(3)(D), and (B) any 
        days the petition is before a special master as a 
        result of a remand under subsection (e)(2)(C)), or
            (2) the United States Claims Court fails to enter a 
        judgment under this section on a petition within 420 
        days (excluding (A) any period of suspension under 
        subsection (d)(3)(C) or (d)(3)(D), and (B) any days the 
        petition is before a special master as a result of a 
        remand under subsection (e)(2)(C)) after the date on 
        which the petition was filed,
the special master or court shall notify the petitioner under 
such petition that the petitioner may withdraw the petition 
under section 2121(b) or the petitioner may choose under 
section 2121(b) to have the petition remain before the special 
master or court, as the case may be.
             determination of eligibility and compensation
    Sec. 2113. [300aa-13] (a) General Rule.--
            (1) Compensation shall be awarded under the Program 
        to a petitioner if the special master or court finds on 
        the record as a whole--
                    (A) that the petitioner has demonstrated by 
                a preponderance of the evidence the matters 
                required in the petition by section 2111(c)(1), 
                and
                    (B) that there is not a preponderance of 
                the evidence that the illness, disability, 
                injury, condition, or death described in the 
                petition is due to factors unrelated to the 
                administration of the vaccine described in the 
                petition.
        The special master or court may not make such a finding 
        based on the claims of a petitioner alone, 
        unsubstantiated by medical records or by medical 
        opinion.
            (2) For purposes of paragraph (1), the term 
        ``factors unrelated to the administration of the 
        vaccine''--
                    (A) does not include any idiopathic, 
                unexplained, unknown, hypothetical, or 
                undocumentable cause, factor, injury, illness, 
                or condition, and
                    (B) may, as documented by the petitioner's 
                evidence or other material in the record, 
                include infection, toxins, trauma (including 
                birth trauma and related anoxia), or metabolic 
                disturbances which have no known relation to 
                the vaccine involved, but which in the 
                particular case are shown to have been the 
                agent or agents principally responsible for 
                causing the petitioner's illness, disability, 
                injury, condition, or death.
    (b) Matters To Be Considered.--
            (1) In determining whether to award compensation to 
        a petitioner under the Program, the special master or 
        court shall consider, in addition to all other relevant 
        medical and scientific evidence contained in the 
        record--
                    (A) any diagnosis, conclusion, medical 
                judgment, or autopsy or coroner's report which 
                is contained in the record regarding the 
                nature, causation, and aggravation of the 
                petitioner's illness, disability, injury, 
                condition, or death, and
                    (B) the results of any diagnostic or 
                evaluative test which are contained in the 
                record and the summaries and conclusions.
        Any such diagnosis, conclusion, judgment, test result, 
        report, or summary shall not be binding on the special 
        master or court. In evaluating the weight to be 
        afforded to any such diagnosis, conclusion, judgment, 
        test result, report, or summary, the special master or 
        court shall consider the entire record and the course 
        of the injury, disability, illness, or condition until 
        the date of the judgment of the special master or 
        court.
            (2) The special master or court may find the first 
        symptom or manifestation of onset or significant 
        aggravation of an injury, disability, illness, 
        condition, or death described in a petition occurred 
        within the time period described in the Vaccine Injury 
        Table even though the occurrence of such symptom or 
        manifestation was not recorded or was incorrectly 
        recorded as having occurred outside such period. Such a 
        finding may be made only upon demonstration by a 
        preponderance of the evidence that the onset or 
        significant aggravation of the injury, disability, 
        illness, condition, or death described in the petition 
        did in fact occur within the time period described in 
        the Vaccine Injury Table.
    (c) Record Defined.--For purposes of this section, the term 
``record'' means the record established by the special masters 
of the United States Claims Court in a proceeding on a petition 
filed under section 2111.
                          vaccine injury table
    Sec. 2114. [300aa-14] (a) Initial Table.--The following is 
a table of vaccines, the injuries, disabilities, illnesses, 
conditions, and deaths resulting from the administration of 
such vaccines, and the time period in which the first symptom 
or manifestation of onset or of the significant aggravation of 
such injuries, disabilities, illnesses, conditions, and deaths 
is to occur after vaccine administration for purposes of 
receiving compensation under the Program:

                          VACCINE INJURY TABLE


I.                    DTP; P; DTP/Polio
                       Combination; or Any
                       Other Vaccine
                       Containing Whole Cell
                       Pertussis Bacteria,
                       Extracted or Partial
                       Cell Bacteria, or
                       Specific Pertussis
                       Antigen(s).
                      Illness, disability,      Time period for first
                       injury, or condition      symptom or
                       covered:                  manifestation of onset
                                                 or of significant
                                                 aggravation after
                                                 vaccine administration:
                      A. Anaphylaxis or         24 hours
                       anaphylactic shock.
                      B. Encephalopathy (or      3 days
                       encephalitis).
                      C. Shock-collapse or       3 days
                       hypotonic-
                       hyporesponsive collapse.
                      D. Residual seizure        3 days
                       disorder in accordance
                       with subsection (b)(2).
                      E. Any acute              Not applicable
                       complication or sequela
                       (including death) of an
                       illness, disability,
                       injury, or condition
                       referred to above which
                       illness, disability,
                       injury, or condition
                       arose within the time
                       period prescribed.
II.                   Measles, mumps, rubella,
                       or any vaccine
                       containing any of the
                       foregoing as a
                       component; DT; Td; or
                       Tetanus Toxoid.
                      A. Anaphylaxis or         24 hours
                       anaphylactic shock.
                      B. Encephalopathy (or     15 days (for mumps,
                       encephalitis).            rubella, measles, or
                                                 any vaccine containing
                                                 any of the foregoing as
                                                 a component). 3 days
                                                 (for DT, Td, or tetanus
                                                 toxoid).
                      C. Residual seizure       15 days (for mumps,
                       disorder in accordance    rubella, measles, or
                       with subsection (b)(2).   any vaccine containing
                                                 any of the foregoing as
                                                 a component). 3 days
                                                 (for DT, Td, or tetanus
                                                 toxoid).
                      D. Any acute              Not applicable
                       complication or sequela
                       (including death) of an
                       illness, disability,
                       injury, or condition
                       referred to above which
                       illness, disability,
                       injury, or condition
                       arose within the time
                       period prescribed.
III.                  Polio Vaccines (other
                       than Inactivated Polio
                       Vaccine).
                      A. Paralytic polio
                        --in a non-             30 days
                         immunodeficient
                         recipient.
                        --in an                  6 months
                         immunodeficient
                         recipient.
                        --in a vaccine-         Not applicable
                         associated community
                         case.
                      B. Any acute              Not applicable
                       complication or sequela
                       (including death) of an
                       illness, disability,
                       injury, or condition
                       referred to above which
                       illness, disability,
                       injury, or condition
                       arose within the time
                       period prescribed.
IV.                   Inactivated Polio
                       Vaccine.
                      A. Anaphylaxis or         24 hours
                       anaphylactic shock.
                      B. Any acute              Not applicable
                       complication or sequela
                       (including death) of an
                       illness, disability,
                       injury, or condition
                       referred to above which
                       illness, disability,
                       injury, or condition
                       arose within the time
                       period prescribed.
 


    (b) Qualifications and Aids to Interpretation.--The 
following qualifications and aids to interpretation shall apply 
to the Vaccine Injury Table in subsection (a):
            (1) A shock-collapse or a hypotonic-hyporesponsive 
        collapse may be evidenced by indicia or symptoms such 
        as decrease or loss of muscle tone, paralysis (partial 
        or complete), hemiplegia or hemiparesis, loss of color 
        or turning pale white or blue, unresponsiveness to 
        environmental stimuli, depression of consciousness, 
        loss of consciousness, prolonged sleeping with 
        difficulty arousing, or cardiovascular or respiratory 
        arrest.
            (2) A petitioner may be considered to have suffered 
        a residual seizure disorder if the petitioner did not 
        suffer a seizure or convulsion unaccompanied by fever 
        or accompanied by a fever of less than 102 degrees 
        Fahrenheit before the first seizure or convulsion after 
        the administration of the vaccine involved and if--
                    (A) in the case of a measles, mumps, or 
                rubella vaccine or any combination of such 
                vaccines, the first seizure or convulsion 
                occurred within 15 days after administration of 
                the vaccine and 2 or more seizures or 
                convulsions occurred within 1 year after the 
                administration of the vaccine which were 
                unaccompanied by fever or accompanied by a 
                fever of less than 102 degrees Fahrenheit, and
                    (B) in the case of any other vaccine, the 
                first seizure or convulsion occurred within 3 
                days after administration of the vaccine and 2 
                or more seizures or convulsions occurred within 
                1 year after the administration of the vaccine 
                which were unaccompanied by fever or 
                accompanied by a fever of less than 102 degrees 
                Fahrenheit.
            (3)(A) The term ``encephalopathy'' means any 
        significant acquired abnormality of, or injury to, or 
        impairment of function of the brain. Among the frequent 
        manifestations of encephalopathy are focal and diffuse 
        neurologic signs, increased intracranial pressure, or 
        changes lasting at least 6 hours in level of 
        consciousness, with or without convulsions. The 
        neurological signs and symptoms of encephalopathy may 
        be temporary with complete recovery, or may result in 
        various degrees of permanent impairment. Signs and 
        symptoms such as high pitched and unusual screaming, 
        persistent unconsolable crying, and bulging fontanel 
        are compatible with an encephalopathy, but in and of 
        themselves are not conclusive evidence of 
        encephalopathy. Encephalopathy usually can be 
        documented by slow wave activity on an 
        electroencephalogram.
            (B) If in a proceeding on a petition it is shown by 
        a preponderance of the evidence that an encephalopathy 
        was caused by infection, toxins, trauma, or metabolic 
        disturbances the encephalopathy shall not be considered 
        to be a condition set forth in the table. If at the 
        time a judgment is entered on a petition filed under 
        section 2111 for a vaccine-related injury or death it 
        is not possible to determine the cause, by a 
        preponderance of the evidence, of an encephalopathy, 
        the encephalopathy shall be considered to be a 
        condition set forth in the table. In determining 
        whether or not an encephalopathy is a condition set 
        forth in the table, the court shall consider the entire 
        medical record.
            (4) For purposes of paragraphs (2) and (3), the 
        terms ``seizure'' and ``convulsion'' include grand mal, 
        petit mal, absence, myoclonic, tonic-clonic, and focal 
        motor seizures and signs. If a provision of the table 
        to which paragraph (1), (2), (3), or (4) applies is 
        revised under subsection (c) or (d), such paragraph 
        shall not apply to such provision after the effective 
        date of the revision unless the revision specifies that 
        such paragraph is to continue to apply.
    (c) Administrative Revision of the Table.--
            (1) The Secretary may promulgate regulations to 
        modify in accordance with paragraph (3) the Vaccine 
        Injury Table. In promulgating such regulations, the 
        Secretary shall provide for notice and opportunity for 
        a public hearing and at least 180 days of public 
        comment.
            (2) Any person (including the Advisory Commission 
        on Childhood Vaccines) may petition the Secretary to 
        propose regulations to amend the Vaccine Injury Table. 
        Unless clearly frivolous, or initiated by the 
        Commission, any such petition shall be referred to the 
        Commission for its recommendations. Following--
                    (A) receipt of any recommendation of the 
                Commission, or
                    (B) 180 days after the date of the referral 
                to the Commission,
        whichever occurs first, the Secretary shall conduct a 
        rulemaking proceeding on the matters proposed in the 
        petition or publish in the Federal Register a statement 
        of reasons for not conducting such proceeding.
            (3) A modification of the Vaccine Injury Table 
        under paragraph (1) may add to, or delete from, the 
        list of injuries, disabilities, illnesses, conditions, 
        and deaths for which compensation may be provided or 
        may change the time periods for the first symptom or 
        manifestation of the onset or the significant 
        aggravation of any such injury, disability, illness, 
        condition, or death.
            (4) Any modification under paragraph (1) of the 
        Vaccine Injury Table shall apply only with respect to 
        petitions for compensation under the Program which are 
        filed after the effective date of such regulation.
    (d) Role of Commission.--Except with respect to a 
regulation recommended by the Advisory Commission on Childhood 
Vaccines, the Secretary may not propose a regulation under 
subsection (c) or any revision thereof, unless the Secretary 
has first provided to the Commission a copy of the proposed 
regulation or revision, requested recommendations and comments 
by the Commission, and afforded the Commission at least 90 days 
to make such recommendations.
    (e) \1\ Additional Vaccines.--
---------------------------------------------------------------------------
    \1\ Section 13632(a)(3) of Public Law 103-66 (107 Stat. 646) 
provides as follows:
---------------------------------------------------------------------------

          ``(3) Effective date.--A revision by the Secretary under 
        section 2114(e) of the Public Health Service Act (42 U.S.C. 
        300aa-14(e)) (as amended by paragraph (2)) shall take effect 
        upon the effective date of a tax enacted to provide funds for 
        compensation paid with respect to the vaccine to be added to 
        the vaccine injury table in section 2114(a) of the Public 
        Health Service Act (42 U.S.C. 300aa-14(a)).''.
            (1) Vaccines recommended before august 1, 1993.--By 
        August 1, 1995, the Secretary shall revise the Vaccine 
        Injury Table included in subsection (a) to include--
                    (A) vaccines which are recommended to the 
                Secretary by the Centers for Disease Control 
                and Prevention before August 1, 1993, for 
                routine administration to children,
                    (B) the injuries, disabilities, illnesses, 
                conditions, and deaths associated with such 
                vaccines, and
                    (C) the time period in which the first 
                symptoms or manifestations of onset or other 
                significant aggravation of such injuries, 
                disabilities, illnesses, conditions, and deaths 
                associated with such vaccines may occur.
            (2) Vaccines recommended after august 1, 1993.--
        When after August 1, 1993, the Centers for Disease 
        Control and Prevention recommends a vaccine to the 
        Secretary for routine administration to children, the 
        Secretary shall, within 2 years of such recommendation, 
        amend the Vaccine Injury Table included in subsection 
        (a) to include--
                    (A) vaccines which were recommended for 
                routine administration to children,
                    (B) the injuries, disabilities, illnesses, 
                conditions, and deaths associated with such 
                vaccines, and
                    (C) the time period in which the first 
                symptoms or manifestations of onset or other 
                significant aggravation of such injuries, 
                disabilities, illnesses, conditions, and deaths 
                associated with such vaccines may occur.
                              compensation
    Sec. 2115. [300aa-15] (a) General Rule.--Compensation 
awarded under the Program to a petitioner under section 2111 
for a vaccine-related injury or death associated with the 
administration of a vaccine after the effective date of this 
part \1\ shall include the following:
---------------------------------------------------------------------------
    \1\ Effective October 1, 1988.
---------------------------------------------------------------------------
            (1)(A) Actual unreimbursable expenses incurred from 
        the date of the judgment awarding such expenses and 
        reasonable projected unreimbursable expenses which--
                    (i) result from the vaccine-related injury 
                for which the petitioner seeks compensation,
                    (ii) have been or will be incurred by or on 
                behalf of the person who suffered such injury, 
                and
                    (iii)(I) have been or will be for diagnosis 
                and medical or other remedial care determined 
                to be reasonably necessary, or
                    (II) have been or will be for 
                rehabilitation, developmental evaluation, 
                special education, vocational training and 
                placement, case management services, 
                counseling, emotional or behavioral therapy, 
                residential and custodial care and service 
                expenses, special equipment, related travel 
                expenses, and facilities determined to be 
                reasonably necessary.
            (B) Subject to section 2116(a)(2), actual 
        unreimbursable expenses incurred before the date of the 
        judgment awarding such expenses which--
                    (i) resulted from the vaccine-related 
                injury for which the petitioner seeks 
                compensation,
                    (ii) were incurred by or on behalf of the 
                person who suffered such injury, and
                    (iii) were for diagnosis, medical or other 
                remedial care, rehabilitation, developmental 
                evaluation, special education, vocational 
                training and placement, case management 
                services, counseling, emotional or behavioral 
                therapy, residential and custodial care and 
                service expenses, special equipment, related 
                travel expenses, and facilities determined to 
                be reasonably necessary.
            (2) In the event of a vaccine-related death, an 
        award of $250,000 for the estate of the deceased.
            (3)(A) In the case of any person who has sustained 
        a vaccine-related injury after attaining the age of 18 
        and whose earning capacity is or has been impaired by 
        reason of such person's vaccine-related injury for 
        which compensation is to be awarded, compensation for 
        actual and anticipated loss of earnings determined in 
        accordance with generally recognized actuarial 
        principles and projections.
            (B) In the case of any person who has sustained a 
        vaccine-related injury before attaining the age of 18 
        and whose earning capacity is or has been impaired by 
        reason of such person's vaccine-related injury for 
        which compensation is to be awarded and whose vaccine-
        related injury is of sufficient severity to permit 
        reasonable anticipation that such person is likely to 
        suffer impaired earning capacity at age 18 and beyond, 
        compensation after attaining the age of 18 for loss of 
        earnings determined on the basis of the average gross 
        weekly earnings of workers in the private, non-farm 
        sector, less appropriate taxes and the average cost of 
        a health insurance policy, as determined by the 
        Secretary.
            (4) For actual and projected pain and suffering and 
        emotional distress from the vaccine-related injury, an 
        award not to exceed $250,000.
    (b) Vaccines Administered Before the Effective Date.--
Compensation awarded under the Program to a petitioner under 
section 2111 for a vaccine-related injury or death associated 
with the administration of a vaccine before the effective date 
of this part \1\ may include the compensation described in 
paragraphs (1)(A) and (2) of subsection (a) and may also 
include an amount, not to exceed a combined total of $30,000, 
for--
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    \1\ Effective October 1, 1988.
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                    (1) lost earnings (as provided in paragraph 
                (3) of subsection (a)),
                    (2) pain and suffering (as provided in 
                paragraph (4) of subsection (a)), and
                    (3) reasonable attorneys' fees and costs 
                (as provided in subsection (e) \2\.
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    \2\ So in law. Probably should be a closing parenthesis after 
``subsection (e)''.
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    (c) Residential and Custodial Care and Service.--The amount 
of any compensation for residential and custodial care and 
service expenses under subsection (a)(1) shall be sufficient to 
enable the compensated person to remain living at home.
    (d) Types of Compensation Prohibited.--Compensation awarded 
under the Program may not include the following:
            (1) Punitive or exemplary damages.
            (2) Except with respect to compensation payments 
        under paragraphs (2) and (3) of subsection (a), 
        compensation for other than the health, education, or 
        welfare of the person who suffered the vaccine-related 
        injury with respect to which the compensation is paid.
    (e) Attorneys' Fees.--
            (1) In awarding compensation on a petition filed 
        under section 2111 the special master or court shall 
        also award as part of such compensation an amount to 
        cover--
                    (A) reasonable attorneys' fees, and
                    (B) other costs,
        incurred in any proceeding on such petition. If the 
        judgment of a special master or court on such a 
        petition does not award compensation, the special 
        master or court may award an amount of compensation to 
        cover petitioner's reasonable attorneys' fees and other 
        costs incurred in any proceeding on such petition if 
        the special master or court determines that the 
        petition was brought in good faith and there was a 
        reasonable basis for the claim for which the petition 
        was brought.
            (2) If the petitioner, before the effective date of 
        this part, \1\ filed a civil action for damages for any 
        vaccine-related injury or death for which compensation 
        may be awarded under the Program, and petitioned under 
        section 2111(a)(5) to have such action dismissed and to 
        file a petition for compensation under the Program, in 
        awarding compensation on such petition the special 
        master or court may include an amount of compensation 
        limited to the costs and expenses incurred by the 
        petitioner and the attorney of the petitioner before 
        the effective date of this part \1\ in preparing, 
        filing, and prosecuting such civil action (including 
        the reasonable value of the attorney's time if the 
        civil action was filed under contingent fee 
        arrangements).
            (3) No attorney may charge any fee for services in 
        connection with a petition filed under section 2111 
        which is in addition to any amount awarded as 
        compensation by the special master or court under 
        paragraph (1).
    (f) Payment of Compensation.--
            (1) Except as provided in paragraph (2), no 
        compensation may be paid until an election has been 
        made, or has been deemed to have been made, under 
        section 2121(a) to receive compensation.
            (2) Compensation described in subsection 
        (a)(1)(A)(iii) shall be paid from the date of the 
        judgment of the United States Claims Court under 
        section 2112 awarding the compensation. Such 
        compensation may not be paid after an election under 
        section 2121(a) to file a civil action for damages for 
        the vaccine-related injury or death for which such 
        compensation was awarded.
            (3) Payments of compensation under the Program and 
        the costs of carrying out the Program shall be exempt 
        from reduction under any order issued under part C of 
        the Balanced Budget and Emergency Deficit Control Act 
        of 1985.
            (4)(A) \1\ Except as provided in subparagraph (B), 
        payment of compensation under the Program shall be 
        determined on the basis of the net present value of the 
        elements of the compensation and shall be paid from the 
        Vaccine Injury Compensation Trust Fund established 
        under section 9510 of the Internal Revenue Code of 1986 
        in a lump sum of which all or a portion may be used as 
        ordered by the special master to purchase an annuity or 
        otherwise be used, with the consent of the petitioner, 
        in a manner determined by the special master to be in 
        the best interests of the petitioner.
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    \1\ See footnote for section 2112(g).
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            (B) In the case of a payment of compensation under 
        the Program to a petitioner for a vaccine-related 
        injury or death associated with the administration of a 
        vaccine before the effective date of this part \2\ the 
        compensation shall be determined on the basis of the 
        net present value of the elements of compensation and 
        paid in 4 equal annual installments of which all or a 
        portion of the proceeds \1\ may be used as ordered by 
        the special master to purchase an annuity or otherwise 
        be used, with the consent of the petitioner, in a 
        manner determined by the special master to be in the 
        best interests of the petitioner. Any reasonable 
        attorneys' fees and costs shall be paid in a lump sum. 
        If the appropriations under subsection (j) are 
        insufficient to make a payment of an annual 
        installment, the limitation on civil actions prescribed 
        by section 2121(a) shall not apply to a civil action 
        for damages brought by the petitioner entitled to the 
        payment.
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    \2\ Effective October 1, 1988.
    \1\ Section 201(e)(1)(B) of Public Law 102-168 (105 Stat. 1103) 
provided that this subparagraph is amended by striking out ``paid in 4 
equal installments of which all or portion of the proceeds'' and 
inserting in lieu thereof ``shall be paid from appropriations made 
available under subsection (j) in a lump sum of which all or a 
portion''. The amendment cannot be executed because the term to be 
struck does not appear in the law. (Compare ``equal installments'' with 
``equal annual installments'' and ``or portion'' with ``or a 
portion''.)
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            (C) In purchasing an annuity under subparagraph (A) 
        or (B), the Secretary may purchase a guarantee for the 
        annuity, may enter into agreements regarding the 
        purchase price for and rate of return of the annuity, 
        and may take such other actions as may be necessary to 
        safeguard the financial interests of the United States 
        regarding the annuity. Any payment received by the 
        Secretary pursuant to the preceding sentence shall be 
        paid to the Vaccine Injury Compensation Trust Fund 
        established under section 9510 of the Internal Revenue 
        Code of 1986, or to the appropriations account from 
        which the funds were derived to purchase the annuity, 
        whichever is appropriate.
    (g) Program Not Primarily Liable.--Payment of compensation 
under the Program shall not be made for any item or service to 
the extent that payment has been made, or can reasonably be 
expected to be made, with respect to such item or service (1) 
under any State compensation program, under an insurance 
policy, or under any Federal or State health benefits program 
(other than under title XIX of the Social Security Act), or (2) 
by an entity which provides health services on a prepaid basis.
    (h) Liability of Health Insurance Carriers, Prepaid Health 
Plans, and Benefit Providers.--No policy of health insurance 
may make payment of benefits under the policy secondary to the 
payment of compensation under the Program and--
            (1) no State, and
            (2) no entity which provides health services on a 
        prepaid basis or provides health benefits,
may make the provision of health services or health benefits 
secondary to the payment of compensation under the Program, 
except that this subsection shall not apply to the provision of 
services or benefits under title XIX of the Social Security 
Act.
    (i) Source of Compensation.--
            (1) Payment of compensation under the Program to a 
        petitioner for a vaccine-related injury or death 
        associated with the administration of a vaccine before 
        the effective date of this part \1\ shall be made by 
        the Secretary from appropriations under subsection (j).
            (2) Payment of compensation under the Program to a 
        petitioner for a vaccine-related injury or death 
        associated with the administration of a vaccine on or 
        after the effective date of this part \1\ shall be made 
        from the Vaccine Injury Compensation Trust Fund 
        established under section 9510 of the Internal Revenue 
        Code of 1986.
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    \1\ Effective October 1, 1988.
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    (j) Authorization.--For the payment of compensation under 
the Program to a petitioner for a vaccine-related injury or 
death associated with the administration of a vaccine before 
the effective date of this part \1\ there are authorized to be 
appropriated to the Department of Health and Human Services 
$80,000,000 for fiscal year 1989, $80,000,000 for fiscal year 
1990, $80,000,000 for fiscal year 1991, $80,000,000 for fiscal 
year 1992, $110,000,000 for fiscal year 1993, and $110,000,000 
for each succeeding fiscal year in which a payment of 
compensation is required under subsection (f)(4)(B). Amounts 
appropriated under this subsection shall remain available until 
expended.
                         limitations of actions
    Sec. 2116. [300aa-16] (a) General Rule.--In the case of--
            (1) a vaccine set forth in the Vaccine Injury Table 
        which is administered before the effective date of this 
        part, \1\ if a vaccine-related injury or death occurred 
        as a result of the administration of such vaccine, no 
        petition may be filed for compensation under the 
        Program for such injury or death after the expiration 
        of 28 months after the effective date of this part \1\ 
        and no such petition may be filed if the first symptom 
        or manifestation of onset or of the significant 
        aggravation of such injury occurred more than 36 months 
        after the date of administration of the vaccine,
            (2) a vaccine set forth in the Vaccine Injury Table 
        which is administered after the effective date of this 
        part, \1\ if a vaccine-related injury occurred as a 
        result of the administration of such vaccine, no 
        petition may be filed for compensation under the 
        Program for such injury after the expiration of 36 
        months after the date of the occurrence of the first 
        symptom or manifestation of onset or of the significant 
        aggravation of such injury, and
            (3) a vaccine set forth in the Vaccine Injury Table 
        which is administered after the effective date of this 
        part, \1\ if a death occurred as a result of the 
        administration of such vaccine, no petition may be 
        filed for compensation under the Program for such death 
        after the expiration of 24 months from the date of the 
        death and no such petition may be filed more than 48 
        months after the date of the occurrence of the first 
        symptom or manifestation of onset or of the significant 
        aggravation of the injury from which the death 
        resulted.
    (b) Effect of Revised Table.--If at any time the Vaccine 
Injury Table is revised and the effect of such revision is to 
permit an individual who was not, before such revision, 
eligible to seek compensation under the Program, or to 
significantly increase the likelihood of obtaining 
compensation, such person may, notwithstanding section 
2111(b)(2), file a petition for such compensation not later 
than 2 years after the effective date of the revision, except 
that no compensation may be provided under the Program with 
respect to a vaccine-related injury or death covered under the 
revision of the table if--
            (1) the vaccine-related death occurred more than 8 
        years before the date of the revision of the table, or
            (2) the vaccine-related injury occurred more than 8 
        years before the date of the revision of the table.
    (c) \1\ State Limitations of Actions.--If a petition is 
filed under section 2111 for a vaccine-related injury or death, 
limitations of actions under State law shall be stayed with 
respect to a civil action brought for such injury or death for 
the period beginning on the date the petition is filed and 
ending on the date (1) an election is made under section 
2121(a) to file the civil action or (2) an election is made 
under section 2121(b) to withdraw the petition.
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    \1\ See footnote for section 2112(g).
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                              subrogration
    Sec. 2117. [300aa-17] (a) General Rule.--Upon payment of 
compensation to any petitioner under the Program, the trust 
fund which has been established to provide such compensation 
shall be subrograted \2\ to all rights of the petitioner with 
respect to the vaccine-related injury or death for which 
compensation was paid, except that the trust fund may not 
recover under such rights an amount greater than the amount of 
compensation paid to the petitioner.
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    \2\ So in law. Probably should be ``subrogated''.
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    (b) Disposition of Amounts Recovered.--Amounts recovered 
under subsection (a) shall be collected on behalf of, and 
deposited in, the Vaccine Injury Compensation Trust Fund 
established under section 9510 of the Internal Revenue Code of 
1986.
               advisory commission on childhood vaccines
    Sec. 2119. [300aa-19] (a) Establishment.--There is 
established the Advisory Commission on Childhood Vaccines. The 
Commission shall be composed of:
            (1) Nine members appointed by the Secretary as 
        follows:
                    (A) Three members who are health 
                professionals, who are not employees of the 
                United States, and who have expertise in the 
                health care of children, the epidemiology, 
                etiology, and prevention of childhood diseases, 
                and the adverse reactions associated with 
                vaccines, of whom at least two shall be 
                pediatricians.
                    (B) Three members from the general public, 
                of whom at least two shall be legal 
                representatives of children who have suffered a 
                vaccine-related injury or death.
                    (C) Three members who are attorneys, of 
                whom at least one shall be an attorney whose 
                specialty includes representation of persons 
                who have suffered a vaccine-related injury or 
                death and of whom one shall be an attorney 
                whose specialty includes representation of 
                vaccine manufacturers.
            (2) The Director of the National Institutes of 
        Health, the Assistant Secretary for Health, the 
        Director of the Centers for Disease Control and 
        Prevention, and the Commissioner of Food and Drugs (or 
        the designees of such officials), each of whom shall be 
        a nonvoting ex officio member.
The Secretary shall select members of the Commission within 90 
days of the effective date of this part. \1\ The members of the 
Commission shall select a Chair from among the members.
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    \1\ Effective October 1, 1988.
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    (b) Term of Office.--Appointed members of the Commission 
shall be appointed for a term of office of 3 years, except that 
of the members first appointed, 3 shall be appointed for a term 
of 1 year, 3 shall be appointed for a term of 2 years, and 3 
shall be appointed for a term of 3 years, as determined by the 
Secretary.
    (c) Meetings.--The Commission shall first meet within 60 
days after all members of the Commission are appointed, and 
thereafter shall meet not less often than four times per year 
and at the call of the chair. A quorum for purposes of a 
meeting is 5. A decision at a meeting is to be made by a ballot 
of a majority of the voting members of the Commission present 
at the meeting.
    (d) Compensation.--Members of the Commission who are 
officers or employees of the Federal Government shall serve as 
members of the Commission without compensation in addition to 
that received in their regular public employment. Members of 
the Commission who are not officers or employees of the Federal 
Government shall be compensated at a rate not to exceed the 
daily equivalent of the rate in effect for grade GS-18 of the 
General Schedule for each day (including traveltime) they are 
engaged in the performance of their duties as members of the 
Commission. All members, while so serving away from their homes 
or regular places of business, may be allowed travel expenses, 
including per diem in lieu of subsistence, in the same manner 
as such expenses are authorized by section 5703, title 5, 
United States Code, for employees serving intermittently.
    (e) Staff.--The Secretary shall provide the Commission with 
such professional and clerical staff, such information, and the 
services of such consultants as may be necessary to assist the 
Commission in carrying out effectively its functions under this 
section.
    (f) Functions.--The Commission shall--
            (1) advise the Secretary on the implementation of 
        the Program,
            (2) on its own initiative or as the result of the 
        filing of a petition, recommend changes in the Vaccine 
        Injury Table,
            (3) advise the Secretary in implementing the 
        Secretary's responsibilities under section 2127 
        regarding the need for childhood vaccination products 
        that result in fewer or no significant adverse 
        reactions,
            (4) survey Federal, State, and local programs and 
        activities relating to the gathering of information on 
        injuries associated with the administration of 
        childhood vaccines, including the adverse reaction 
        reporting requirements of section 2125(b), and advise 
        the Secretary on means to obtain, compile, publish, and 
        use credible data related to the frequency and severity 
        of adverse reactions associated with childhood 
        vaccines, and
            (5) recommend to the Director of the National 
        Vaccine Program research related to vaccine injuries 
        which should be conducted to carry out this subtitle.

                      Part B--Additional Remedies

                       authority to bring actions
    Sec. 2121. [300aa-21] (a) Election.--After judgment has 
been entered by the United States Claims Court or, if an appeal 
is taken under section 2112(f), after the appellate court's 
mandate is issued, the petitioner who filed the petition under 
section 2111 shall file with the clerk of the United States 
Claims Court--
            (1) if the judgment awarded compensation, an 
        election in writing to receive the compensation or to 
        file a civil action for damages for such injury or 
        death, or
            (2) if the judgment did not award compensation, an 
        election in writing to accept the judgment or to file a 
        civil action for damages for such injury or death.
An election shall be filed under this subsection not later than 
90 days after the date of the court's final judgment with 
respect to which the election is to be made. If a person 
required to file an election with the court under this 
subsection does not file the election within the time 
prescribed for filing the election, such person shall be deemed 
to have filed an election to accept the judgment of the court. 
If a person elects to receive compensation under a judgment of 
the court in an action for a vaccine-related injury or death 
associated with the administration of a vaccine before the 
effective date of this part or is deemed to have accepted the 
judgment of the court in such an action, such person may not 
bring or maintain a civil action for damages against a vaccine 
administrator or manufacturer for the vaccine-related injury or 
death for which the judgment was entered. For limitations on 
the bringing of civil actions for vaccine-related injuries or 
deaths associated with the administration of a vaccine after 
the effective date of this part \1\, see section 2111(a)(2).
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    \1\ Effective October 1, 1988.
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    (b) \2\ Continuance or Withdrawal of Petition.\3\--A 
petitioner under a petition filed under section 2111 may submit 
to the United States Claims Court a notice in writing choosing 
to continue or to withdraw the petition if--
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    \2\ See footnote for section 2112(g).
    \3\ The amendment described in section 201(d)(3)(C) of Public Law 
102-168 (105 Stat. 1103) has been executed according to the probable 
intent of the Congress. After redesignating former subparagraphs (A) 
and (B) as paragraphs (1) and (2), the amendatory instructions of the 
section provided that section 2121(b) is amended ``by running the text 
of paragraph (1) into the subsection heading and making the margin of 
the text full measure''. The instructions were applied to portions of 
the matter preceding paragraph (1) as redesignated, rather than to the 
text of paragraph (1). (That is, the instructions were applied to the 
former paragraph (1).)
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                    (1) a special master fails to make a 
                decision on such petition within the 240 days 
                prescribed by section 2112(d)(3)(A)(ii) 
                (excluding (i) any period of suspension under 
                section 2112(d)(3)(C) or 2112(d)(3)(D), and 
                (ii) any days the petition is before a special 
                master as a result of a remand under section 
                2112(e)(2)(C)), or
                    (2) the court fails to enter a judgment 
                under section 2112 on the petition within 420 
                days (excluding (i) any period of suspension 
                under section 2112(d)(3)(C) or 2112(d)(3)(D), 
                and (ii) any days the petition is before a 
                special master as a result of a remand under 
                section 2112(e)(2)(C)) after the date on which 
                the petition was filed.
        Such a notice shall be filed within 30 days of the 
        provision of the notice required by section 2112(g).
    (c) Limitations of Actions.--A civil action for damages 
arising from a vaccine-related injury or death for which a 
petition was filed under section 2111 shall, except as provided 
in section 2116(c), be brought within the period prescribed by 
limitations of actions under State law applicable to such civil 
action.
                      standards of responsibility
    Sec. 2122. [300aa-22] (a) General Rule.--Except as provided 
in subsections (b), (c), and (e) State law shall apply to a 
civil action brought for damages for a vaccine-related injury 
or death.
    (b) Unavoidable Adverse Side Effects; Warnings.--
            (1) No vaccine manufacturer shall be liable in a 
        civil action for damages arising from a vaccine-related 
        injury or death associated with the administration of a 
        vaccine after the effective date of this part \1\ if 
        the injury or death resulted from side effects that 
        were unavoidable even though the vaccine was properly 
        prepared and was accompanied by proper directions and 
        warnings.
            (2) For purposes of paragraph (1), a vaccine shall 
        be presumed to be accompanied by proper directions and 
        warnings if the vaccine manufacturer shows that it 
        complied in all material respects with all requirements 
        under the Federal Food, Drug, and Cosmetic Act and 
        section 351 of the Public Health Service Act (including 
        regulations issued under such provisions) applicable to 
        the vaccine and related to vaccine-related injury or 
        death for which the civil action was brought unless the 
        plaintiff shows--
                    (A) that the manufacturer engaged in the 
                conduct set forth in subparagraph (A) or (B) of 
                section 2123(d)(2), or
                    (B) by clear and convincing evidence that 
                the manufacturer failed to exercise due care 
                notwithstanding its compliance with such Act 
                and section (and regulations issued under such 
                provisions).
    (c) Direct Warnings.--No vaccine manufacturer shall be 
liable in a civil action for damages arising from a vaccine-
related injury or death associated with the administration of a 
vaccine after the effective date of this part \1\ solely due to 
the manufacturer's failure to provide direct warnings to the 
injured party (or the injured party's legal representative) of 
the potential dangers resulting from the administration of the 
vaccine manufactured by the manufacturer.
    (d) Construction.--The standards of responsibility 
prescribed by this section are not to be construed as 
authorizing a person who brought a civil action for damages 
against a vaccine manufacturer for a vaccine-related injury or 
death in which damages were denied or which was dismissed with 
prejudice to bring a new civil action against such manufacturer 
for such injury or death.
    (e) Preemption.--No State may establish or enforce a law 
which prohibits an individual from bringing a civil action 
against a vaccine manufacturer for damages for a vaccine-
related injury or death if such civil action is not barred by 
this subtitle.
                                 trial
    Sec. 2123. [300aa-23] (a) General Rule.--A civil action 
against a vaccine manufacturer for damages for a vaccine-
related injury or death associated with the administration of a 
vaccine after the effective date of this part \1\ which is not 
barred by section 2111(a)(2) shall be tried in three stages.
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    \1\ Effective October 1, 1988.
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    (b) Liability.--The first stage of such a civil action 
shall be held to determine if a vaccine manufacturer is liable 
under section 2122.
    (c) General Damages.--The second stage of such a civil 
action shall be held to determine the amount of damages (other 
than punitive damages) a vaccine manufacturer found to be 
liable under section 2122 shall be required to pay.
    (d) Punitive Damages.--
            (1) If sought by the plaintiff, the third stage of 
        such an action shall be held to determine the amount of 
        punitive damages a vaccine manufacturer found to be 
        liable under section 2122 shall be required to pay.
            (2) If in such an action the manufacturer shows 
        that it complied, in all material respects, with all 
        requirements under the Federal Food, Drug, and Cosmetic 
        Act and the Public Health Service Act applicable to the 
        vaccine and related to the vaccine injury or death with 
        respect to which the action was brought, the 
        manufacturer shall not be held liable for punitive 
        damages unless the manufacturer engaged in--
                    (A) fraud or intentional and wrongful 
                withholding of information from the Secretary 
                during any phase of a proceeding for approval 
                of the vaccine under section 351,
                    (B) intentional and wrongful withholding of 
                information relating to the safety or efficacy 
                of the vaccine after its approval, or
                    (C) other criminal or illegal activity 
                relating to the safety and effectiveness of 
                vaccines,
        which activity related to the vaccine-related injury or 
        death for which the civil action was brought.
    (e) Evidence.--In any stage of a civil action, the Vaccine 
Injury Table, any finding of fact or conclusion of law of the 
United States Claims Court or a special master in a proceeding 
on a petition filed under section 2111 and the final judgment 
of the United States Claims Court and subsequent appellate 
review on such a petition shall not be admissible.

 Part C--Assuring a Safer Childhood Vaccination Program in the United 
                                 States

                 recording and reporting of information
    Sec. 2125. [300aa-25] (a) General Rule.--Each health care 
provider who administers a vaccine set forth in the Vaccine 
Injury Table to any person shall record, or ensure that there 
is recorded, in such person's permanent medical record (or in a 
permanent office log or file to which a legal representative 
shall have access upon request) with respect to each such 
vaccine--
            (1) the date of administration of the vaccine,
            (2) the vaccine manufacturer and lot number of the 
        vaccine,
            (3) the name and address and, if appropriate, the 
        title of the health care provider administering the 
        vaccine, and
            (4) any other identifying information on the 
        vaccine required pursuant to regulations promulgated by 
        the Secretary.
    (b) Reporting.--
            (1) Each health care provider and vaccine 
        manufacturer shall report to the Secretary--
                    (A) the occurrence of any event set forth 
                in the Vaccine Injury Table, including the 
                events set forth in section 2114(b) which occur 
                within 7 days of the administration of any 
                vaccine set forth in the Table or within such 
                longer period as is specified in the Table or 
                section,
                    (B) the occurrence of any contraindicating 
                reaction to a vaccine which is specified in the 
                manufacturer's package insert, and
                    (C) such other matters as the Secretary may 
                by regulation require.
        Reports of the matters referred to in subparagraphs (A) 
        and (B) shall be made beginning 90 days after the 
        effective date of this part. \1\ The Secretary shall 
        publish in the Federal Register as soon as practicable 
        after such date a notice of the reporting requirement.
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    \1\ Effective December 22, 1987.
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            (2) A report under paragraph (1) respecting a 
        vaccine shall include the time periods after the 
        administration of such vaccine within which vaccine-
        related illnesses, disabilities, injuries, or 
        conditions, the symptoms and manifestations of such 
        illnesses, disabilities, injuries, or conditions, or 
        deaths occur, and the manufacturer and lot number of 
        the vaccine.
            (3) The Secretary shall issue the regulations 
        referred to in paragraph (1)(C) within 180 days of the 
        effective date of this part. \1\
    (c) Release of Information.--
            (1) Information which is in the possession of the 
        Federal Government and State and local governments 
        under this section and which may identify an individual 
        shall not be made available under section 552 of title 
        5, United States Code, or otherwise, to any person 
        except--
                    (A) the person who received the vaccine, or
                    (B) the legal representative of such 
                person.
            (2) For purposes of paragraph (1), the term 
        ``information which may identify an individual'' shall 
        be limited to the name, street address, and telephone 
        number of the person who received the vaccine and of 
        that person's legal representative and the medical 
        records of such person relating to the administration 
        of the vaccine, and shall not include the locality and 
        State of vaccine administration, the name of the health 
        care provider who administered the vaccine, the date of 
        the vaccination, or information concerning any reported 
        illness, disability, injury, or condition resulting 
        from the administration of the vaccine, any symptom or 
        manifestation of such illness, disability, injury, or 
        condition, or death resulting from the administration 
        of the vaccine.
            (3) Except as provided in paragraph (1), all 
        information reported under this section shall be 
        available to the public.
                          vaccine information
    Sec. 2126. [300aa-26] (a) General Rule.--Not later than 1 
year after the effective date of this part, \1\ the Secretary 
shall develop and disseminate vaccine information materials for 
distribution by health care providers to the legal 
representatives of any child or to any other individual 
receiving a vaccine set forth in the Vaccine Injury Table. Such 
materials shall be published in the Federal Register and may be 
revised.
    (b) Development and Revision of Materials.--Such materials 
shall be developed or revised--
            (1) after notice to the public and 60 days of 
        comment thereon, and
            (2) in consultation with the Advisory Commission on 
        Childhood Vaccines, appropriate health care providers 
        and parent organizations, the Centers for Disease 
        Control and Prevention, and the Food and Drug 
        Administration.
    (c) Information Requirements.--The information in such 
materials shall be based on available data and information, 
shall be presented in understandable terms and shall include--
            (1) a concise description of the benefits of the 
        vaccine,
            (2) a concise description of the risks associated 
        with the vaccine,
            (3) a statement of the availability of the National 
        Vaccine Injury Compensation Program, and
            (4) such other relevant information as may be 
        determined by the Secretary.
    (d) Health Care Provider Duties.--On and after a date 
determined by the Secretary which is--
            (1) after the Secretary develops the information 
        materials required by subsection (a), and
            (2) not later than 6 months after the date such 
        materials are published in the Federal Register,
each health care provider who administers a vaccine set forth 
in the Vaccine Injury Table shall provide to the legal 
representatives of any child or to any other individual to whom 
such provider intends to administer such vaccine a copy of the 
information materials developed pursuant to subsection (a), 
supplemented with visual presentations or oral explanations, in 
appropriate cases. Such materials shall be provided prior to 
the administration of such vaccine.
                  mandate for safer childhood vaccines
    Sec. 2127. [300aa-27] (a) General Rule.--In the 
administration of this subtitle and other pertinent laws under 
the jurisdiction of the Secretary, the Secretary shall--
            (1) promote the development of childhood vaccines 
        that result in fewer and less serious adverse reactions 
        than those vaccines on the market on the effective date 
        of this part \1\ and promote the refinement of such 
        vaccines, and
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    \1\ Effective December 22, 1987.
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            (2) make or assure improvements in, and otherwise 
        use the authorities of the Secretary with respect to, 
        the licensing, manufacturing, processing, testing, 
        labeling, warning, use instructions, distribution, 
        storage, administration, field surveillance, adverse 
        reaction reporting, and recall of reactogenic lots or 
        batches, of vaccines, and research on vaccines, in 
        order to reduce the risks of adverse reactions to 
        vaccines.
    (b) Task Force.--
            (1) The Secretary shall establish a task force on 
        safer childhood vaccines which shall consist of the 
        Director of the National Institutes of Health, the 
        Commissioner of the Food and Drug Administration, and 
        the Director of the Centers for Disease Control.
            (2) The Director of the National Institutes of 
        Health shall serve as chairman of the task force.
            (3) In consultation with the Advisory Commission on 
        Childhood Vaccines, the task force shall prepare 
        recommendations to the Secretary concerning 
        implementation of the requirements of subsection (a).
    (c) Report.--Within 2 years after the effective date of 
this part, \1\ and periodically thereafter, the Secretary shall 
prepare and transmit to the Committee on Energy and Commerce of 
the House of Representatives and the Committee on Labor and 
Human Resources of the Senate a report describing the actions 
taken pursuant to subsection (a) during the preceding 2-year 
period.
                manufacturer recordkeeping and reporting
    Sec. 2128. [300aa-28] (a) General Rule.--Each vaccine 
manufacturer of a vaccine set forth in the Vaccine Injury Table 
or any other vaccine the administration of which is mandated by 
the law or regulations of any State, shall, with respect to 
each batch, lot, or other quantity manufactured or licensed 
after the effective date of this part-- \1\
            (1) prepare and maintain records documenting the 
        history of the manufacturing, processing, testing, 
        repooling, and reworking of each batch, lot, or other 
        quantity of such vaccine, including the identification 
        of any significant problems encountered in the 
        production, testing, or handling of such batch, lot, or 
        other quantity,
            (2) if a safety test on such batch, lot, or other 
        quantity indicates a potential imminent or substantial 
        public health hazard is presented, report to the 
        Secretary within 24 hours of such safety test which the 
        manufacturer (or manufacturer's representative) 
        conducted, including the date of the test, the type of 
        vaccine tested, the identity of the batch, lot, or 
        other quantity tested, whether the batch, lot, or other 
        quantity tested is the product of repooling or 
        reworking of previous batches, lots, or other 
        quantities (and, if so, the identity of the previous 
        batches, lots, or other quantities which were repooled 
        or reworked), the complete test results, and the name 
        and address of the person responsible for conducting 
        the test,
            (3) include with each such report a certification 
        signed by a responsible corporate official that such 
        report is true and complete, and
            (4) prepare, maintain, and upon request submit to 
        the Secretary product distribution records for each 
        such vaccine by batch, lot, or other quantity number.
    (b) Sanction.--Any vaccine manufacturer who intentionally 
destroys, alters, falsifies, or conceals any record or report 
required under paragraph (1) or (2) of subsection (a) shall--
            (1) be subject to a civil penalty of up to $100,000 
        per occurrence, or
            (2) be fined $50,000 or imprisoned for not more 
        than 1 year, or both.
Such penalty shall apply to the person who intentionally 
destroyed, altered, falsified, or concealed such record or 
report, to the person who directed that such record or report 
be destroyed, altered, falsified, or concealed, and to the 
vaccine manufacturer for which such person is an agent, 
employee, or representative. Each act of destruction, 
alteration, falsification, or concealment shall be treated as a 
separate occurrence.

                       Part D--General Provisions

                           citizen's actions
    Sec. 2131. [300aa-31] (a) General Rule.--Except as provided 
in subsection (b), any person may commence in a district court 
of the United States a civil action on such person's own behalf 
against the Secretary where there is alleged a failure of the 
Secretary to perform any act or duty under this subtitle.
    (b) Notice.--No action may be commenced under subsection 
(a) before the date which is 60 days after the person bringing 
the action has given written notice of intent to commence such 
action to the Secretary.
    (c) Costs of Litigation.--The court, in issuing any final 
order in any action under this section, may award costs of 
litigation (including reasonable attorney and expert witness 
fees) to any plaintiff who substantially prevails on one or 
more significant issues in the action.
                            judicial review
    Sec. 2132. [300aa-32] A petition for review of a regulation 
under this subtitle may be filed in a court of appeals of the 
United States within 60 days from the date of the promulgation 
of the regulation or after such date if such petition is based 
solely on grounds arising after such 60th day.
                              definitions
    Sec. 2133. \1\ [300aa-33] For purposes of this subtitle:
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    \1\ Paragraphs (3) and (5) above appear so as to reflect the 
probable intent of the Congress, and former paragraph (7) has been 
struck to reflect such intent. Sections 1714, 1715, and 1716 of Public 
Law 107-296 (116 Stat. 2320, 2321) made amendments to section 2133 with 
respect to such paragraphs. Subsequently, section 102(a) of division L 
of Public Law 108-7 (117 Stat. 528) was enacted, and that section 
indicated the intent of the Congress to nullify those amendments. That 
section repealed sections 1714, 1715, and 1716 rather than directly 
amending paragraphs (3), (5), and (7). (That section also repealed 
section 1717, which related to effective dates.)
    Section 102(b) of Public Law 108-7 provided as follows: ``The 
Public Health Service Act (42 U.S.C. 201 et seq.) shall be applied and 
administered as if the sections repealed by subsection (a) had never 
been enacted.''. Consistent with that provision, section 2133 is shown 
above to reflect the assumption that repealing a provision of law that 
makes a change in an Act has the effect of amending that Act so as to 
undo the change.
    Section 102(c) of such Public Law provides as follows: ``No 
inference shall be drawn from the enactment of sections 1714 through 
1717 of the Homeland Security Act of 2002 (Public Law 107-296), or from 
this repeal, regarding the law prior to enactment of sections 1714 
through 1717 of the Homeland Security Act of 2002 (Public Law 107-296). 
Further, no inference shall be drawn that subsection (a) or (b) affects 
any change in that prior law, or that Leroy v. Secretary of Health and 
Human Services, Office of Special Master, No. 02-392V (October 11, 
2002), was incorrectly decided.''.
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            (1) The term ``health care provider'' means any 
        licensed health care professional, organization, or 
        institution, whether public or private (including 
        Federal, State, and local departments, agencies, and 
        instrumentalities) under whose authority a vaccine set 
        forth in the Vaccine Injury Table is administered.
            (2) The term ``legal representative'' means a 
        parent or an individual who qualifies as a legal 
        guardian under State law.
            (3) The term ``manufacturer'' means any 
        corporation, organization, or institution, whether 
        public or private (including Federal, State, and local 
        departments, agencies, and instrumentalities), which 
        manufactures, imports, processes, or distributes under 
        its label any vaccine set forth in the Vaccine Injury 
        Table, except that, for purposes of section 2128, such 
        term shall include the manufacturer of any other 
        vaccine covered by that section. The term 
        ``manufacture'' means to manufacture, import, process, 
        or distribute a vaccine.
            (4) The term ``significant aggravation'' means any 
        change for the worse in a preexisting condition which 
        results in markedly greater disability, pain, or 
        illness accompanied by substantial deterioration of 
        health.
            (5) The term ``vaccine-related injury or death'' 
        means an illness, injury, condition, or death 
        associated with one or more of the vaccines set forth 
        in the Vaccine Injury Table, except that the term does 
        not include an illness, injury, condition, or death 
        associated with an adulterant or contaminant 
        intentionally added to such a vaccine.
            (6)(A) The term ``Advisory Commission on Childhood 
        Vaccines'' means the Commission established under 
        section 2119.
            (B) The term ``Vaccine Injury Table'' means the 
        table set out in section 2114.
                 h3  deg.termination of program
    Sec. 2134. [300aa-34] (a) Reviews.--The Secretary shall 
review the number of awards of compensation made under the 
program to petitioners under section 2111 for vaccine-related 
injuries and deaths associated with the administration of 
vaccines on or after the effective date of this part \1\ as 
follows:
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    \1\ Effective December 22, 1987.
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            (1) The Secretary shall review the number of such 
        awards made in the 12-month period beginning on the 
        effective date of this part. \1\
            (2) At the end of each 3-month period beginning 
        after the expiration of the 12-month period referred to 
        in paragraph (1) the Secretary shall review the number 
        of such awards made in the 3-month period.
    (b) Report.--
            (1) If in conducting a review under subsection (a) 
        the Secretary determines that at the end of the period 
        reviewed the total number of awards made by the end of 
        that period and accepted under section 2121(a) exceeds 
        the number of awards listed next to the period reviewed 
        in the table in paragraph (2)--
                    (A) the Secretary shall notify the Congress 
                of such determination, and
                    (B) beginning 180 days after the receipt by 
                Congress of a notification under paragraph (1), 
                no petition for a vaccine-related injury or 
                death associated with the administration of a 
                vaccine on or after the effective date of this 
                part \1\ may be filed under section 2111.
        Section 2111(a) and part B shall not apply to civil 
        actions for damages for a vaccine-related injury or 
        death for which a petition may not be filed because of 
        subparagraph (B).
            (2) The table referred to in paragraph (1) is as 
        follows:

                                                  Total number of awards
                                                by the end of the period
     Period reviewed:                                           reviewed

       12 months after the effective date of part.......        150     
       13th through the 15th month after such date......        188     
       16th through the 18th month after such date......        225     
       19th through the 21st month after such date......        263     
       22nd through the 24th month after such date......        300     
       25th through the 27th month after such date......        338     
       28th through the 30th month after such date......        375     
       31st through the 33rd month after such date......        413     
       34th through the 36th month after such date......        450     
       37th through the 39th month after such date......        488     
       40th through the 42nd month after such date......        525     
       43rd through the 45th month after such date......        563     
       46th through the 48th month after such date......       600.     
  TITLE XXII--REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR CERTAIN 
                       STATE AND LOCAL EMPLOYEES

SEC. 2201. [300BB-1] STATE AND LOCAL GOVERNMENTAL GROUP HEALTH PLANS 
                    MUST PROVIDE CONTINUATION COVERAGE TO CERTAIN 
                    INDIVIDUALS.

    (a) In General.--In accordance with regulations which the 
Secretary shall prescribe, each group health plan that is 
maintained by any State that receives funds under this Act, by 
any political subdivision of such a State, or by any agency or 
instrumentality of such a State or political subdivision, shall 
provide, in accordance with this title, that each qualified 
beneficiary who would lose coverage under the plan as a result 
of a qualifying event is entitled, under the plan, to elect, 
within the election period, continuation coverage under the 
plan.
    (b) Exception for Certain Plans.--Subsection (a) shall not 
apply to--
            (1) any group health plan for any calendar year if 
        all employers maintaining such plan normally employed 
        fewer than 20 employees on a typical business day 
        during the preceding calendar year, or
            (2) any group health plan maintained for employees 
        by the government of the District of Columbia or any 
        territory or possession of the United States or any 
        agency or instrumentality.

SEC. 2202. [300BB-2] CONTINUATION COVERAGE.

    For purposes of section 2201, the term ``continuation 
coverage'' means coverage under the plan which meets the 
following requirements:
            (1) Type of benefit coverage.--The coverage must 
        consist of coverage which, as of the time the coverage 
        is being provided, is identical to the coverage 
        provided under the plan to similarly situated 
        beneficiaries under the plan with respect to whom a 
        qualifying event has not occurred. If coverage is 
        modified under the plan for any group of similarly 
        situated beneficiaries, such coverage shall also be 
        modified in the same manner for all individuals who are 
        qualified beneficiaries under the plan pursuant to this 
        part \1\ in connection with such group.
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    \1\ So in law. This title is not divided into parts.
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            (2) Period of coverage.--The coverage must extend 
        for at least the period beginning on the date of the 
        qualifying event and ending not earlier than the 
        earliest of the following:
                    (A) Maximum required period.--
                            (i) General rule for terminations 
                        and reduced hours.--In the case of a 
                        qualifying event described in section 
                        2203(2), except as provided in clause 
                        (ii), the date which is 18 months after 
                        the date of the qualifying event.
                            (ii) Special rule for multiple 
                        qualifying events.--If a qualifying 
                        event occurs during the 18 months after 
                        the date of a qualifying event 
                        described in section 2203(2), the date 
                        which is 36 months after the date of 
                        the qualifying event described in 
                        section 2203(2).
                            (iii) General rule for other 
                        qualifying events.--In the case of a 
                        qualifying event not described in 
                        section 2203(2), the date which is 36 
                        months after the date of the qualifying 
                        event.
                            (iv) Special rule for taa-eligible 
                        individuals.--In the case of a 
                        qualifying event described in section 
                        2203(2) with respect to a covered 
                        employee who is (as of the date that 
                        the period of coverage would, but for 
                        this clause or clause (v), otherwise 
                        terminate under clause (i) or (ii)) a 
                        TAA-eligible individual (as defined in 
                        section 2205(b)(4)(B)), the period of 
                        coverage shall not terminate by reason 
                        of clause (i) or (ii), as the case may 
                        be, before the later of the date 
                        specified in such clause or the date on 
                        which such individual ceases to be such 
                        a TAA-eligible individual. The 
                        preceding sentence shall not require 
                        any period of coverage to extend beyond 
                        February 12, 2011.
                            (v) Medicare entitlement followed 
                        by qualifying event.--In the case of a 
                        qualifying event described in section 
                        2203(2) that occurs less than 18 months 
                        after the date the covered employee 
                        became entitled to benefits under title 
                        XVIII of the Social Security Act, the 
                        period of coverage for qualified 
                        beneficiaries other than the covered 
                        employee shall not terminate under this 
                        subparagraph before the close of the 
                        36-month period beginning on the date 
                        the covered employee became so 
                        entitled.
                            (vi) Special rule for disability.--
                        In the case of a qualified beneficiary 
                        who is determined, under title II or 
                        XVI of the Social Security Act, to have 
                        been disabled at any time during the 
                        first 60 days of continuation coverage 
                        under this title, any reference in 
                        clause (i) or (ii) to 18 months with 
                        respect to such event \1\ is deemed a 
                        reference to 29 months (with respect to 
                        all qualified beneficiaries), but only 
                        if the qualified beneficiary has 
                        provided notice of such determination 
                        under section 2206(3) before the end of 
                        such 18 months.
---------------------------------------------------------------------------
    \1\ Section 421(a)(1)(A)(ii)(III) of Public Law 104-191 (110 Stat. 
2087) provides that the last sentence of subparagraph (A) is amended by 
striking ``with respect to such event,''. The amendment cannot be 
executed because the term to be struck does not appear. (Compare ``with 
respect to such event,'' and ``with respect to such event''.)
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                    (B) End of plan.--The date on which the 
                employer ceases to provide any group health 
                plan to any employee.
                    (C) Failure to pay premium.--The date on 
                which coverage ceases under the plan by reason 
                of a failure to make timely payment of any 
                premium required under the plan with respect to 
                the qualified beneficiary. The payment of any 
                premium (other than any payment referred to in 
                the last sentence of paragraph (3)) shall be 
                considered to be timely if made within 30 days 
                after the date due or within such longer period 
                as applies to or under the plan.
                    (D) Group health plan coverage or medicare 
                entitlememt.--The date on which the qualified 
                beneficiary first becomes, after the date of 
                the election--
                            (i) covered under any other group 
                        health plan (as an employee or 
                        otherwise) which does not contain any 
                        exclusion or limitation with respect to 
                        any preexisting condition of such 
                        beneficiary (other than such an 
                        exclusion or limitation which does not 
                        apply to (or is satisfied by) such 
                        beneficiary by reason of chapter 100 of 
                        the Internal Revenue Code of 1986, part 
                        7 of subtitle B of title I of the 
                        Employee Retirement Income Security Act 
                        of 1974, or title XXVII of this Act), 
                        or
                            (ii) entitled to benefits under 
                        title XVIII of the Social Security Act.
                    (E) Termination of extended coverage for 
                disability.--In the case of a qualified 
                beneficiary who is disabled at any time during 
                the first 60 days of continuation coverage 
                under this title, the month that begins more 
                than 30 days after the date of the final 
                determination under title II or XVI of the 
                Social Security Act that the qualified 
                beneficiary is no longer disabled.
            (3) Premium requirements.--The plan may require 
        payment of a premium for any period of continuation 
        coverage, except that such premium--
                    (A) shall not exceed 102 percent of the 
                applicable premium for such period, and
                    (B) may, at the election of the payor, be 
                made in monthly installments.
        In no event may the plan require the payment of any 
        premium before the day which is 45 days after the day 
        on which the qualified beneficiary made the initial 
        election for continuation coverage. In the case of an 
        individual described in the last sentence of paragraph 
        (2)(A), any reference in subparagraph (A) of this 
        paragraph to ``102 percent'' is deemed a reference to 
        ``150 percent'' for any month after the 18th month of 
        continuation coverage described in clause (i) or (ii) 
        of paragraph (2)(A).
            (4) No requirement of insurability.--The coverage 
        may not be conditioned upon, or discriminate on the 
        basis of lack of, evidence of insurability.
            (5) Conversion option.--In the case of a qualified 
        beneficiary whose period of continuation coverage 
        expires under paragraph (2)(A), the plan must, during 
        the 180-day period ending on such expiration date, 
        provide to the qualified beneficiary the option of 
        enrollment under a conversion health plan otherwise 
        generally available under the plan.

SEC. 2203. [300BB-3] QUALIFYING EVENT.

    For purposes of this title, the term ``qualifying event'' 
means, with respect to any covered employee, any of the 
following events which, but for the continuation coverage 
required under this title, would result in the loss of coverage 
of a qualified beneficiary:
            (1) The death of the covered employee.
            (2) The termination (other than by reason of such 
        employee's gross misconduct), or reduction of hours, of 
        the covered employee's  employment.
            (3) The divorce or legal separation of the covered 
        employee from the employee's spouse.
            (4) The covered employee becoming entitled to 
        benefits under title XVIII of the Social Security Act.
            (5) A dependent child ceasing to be a dependent 
        child under the generally applicable requirements of 
        the plan.

SEC. 2204. [300BB-4] APPLICABLE PREMIUM.

    For purposes of this title--
            (1) In general.--The term ``applicable premium'' 
        means, with respect to any period of continuation 
        coverage of qualified beneficiaries, the cost to the 
        plan for such period of the coverage for similarly 
        situated beneficiaries with respect to whom a 
        qualifying event has not occurred (without regard to 
        whether such cost is paid by the employer or employee).
            (2) Special rule for self-insured plans.--To the 
        extent that a plan is a self-insured plan--
                    (A) In general.--Except as provided in 
                subparagraph (B), the applicable premium for 
                any period of continuation coverage of 
                qualified beneficiaries shall be equal to a 
                reasonable estimate of the cost of providing 
                coverage for such period for similarly situated 
                beneficiaries which--
                            (i) is determined on an actuarial 
                        basis, and
                            (ii) takes into account such 
                        factors as the Secretary may prescribe 
                        in regulations.
                    (B) Determination on basis of past cost.--
                If a plan administrator elects to have this 
                subparagraph apply, the applicable premium for 
                any period of continuation coverage of 
                qualified beneficiaries shall be equal to--
                            (i) the cost to the plan for 
                        similarly situated beneficiaries for 
                        the same period occurring during the 
                        preceding determination period under 
                        paragraph (3), adjusted by
                            (ii) the percentage increase or 
                        decrease in the implicit price deflator 
                        of the gross national product 
                        (calculated by the Department of 
                        Commerce and published in the Survey of 
                        Current Business) for the 12-month 
                        period ending on the last day of the 
                        sixth month of such preceding 
                        determination period.
                    (C) Subparagraph (b) not to apply where 
                significant change.--A plan administrator may 
                not elect to have subparagraph (B) apply in any 
                case in which there is any significant 
                difference, between the determination period 
                and the preceding determination period, in 
                coverage under, or in employees covered by, the 
                plan. The determination under the preceding 
                sentence for any determination period shall be 
                made at the same time as the determination 
                under paragraph (3).
            (3) Determination period.--The determination of any 
        applicable premium shall be made for a period of 12 
        months and shall be made before the beginning of such 
        period.

SEC. 2205. [300BB-5] ELECTION.

    (a) In General.--For purposes of this title--
            (1) Election period.--The term ``election period'' 
        means the period which--
                    (A) begins not later than the date on which 
                coverage terminates under the plan by reason of 
                a qualifying event,
                    (B) is of at least 60 days' duration, and
                    (C) ends not earlier than 60 days after the 
                later of--
                            (i) the date described in 
                        subparagraph (A), or
                            (ii) in the case of any qualified 
                        beneficiary who receives notice under 
                        section 2206(4), the date of such 
                        notice.
            (2) Effect of election on other beneficiaries.--
        Except as otherwise specified in an election, any 
        election of continuation coverage by a qualified 
        beneficiary described in subparagraph (A)(i) or (B) of 
        section 2208(3) shall be deemed to include an election 
        of continuation coverage on behalf of any other 
        qualified beneficiary who would lose coverage under the 
        plan by reason of the qualifying event. If there is a 
        choice among types of coverage under the plan, each 
        qualified beneficiary is entitled to make a separate 
        selection among such types of coverage.
    (b) Temporary Extension of COBRA Election Period for 
Certain Individuals.--
            (1) In general.--In the case of a nonelecting TAA-
        eligible individual and notwithstanding subsection (a), 
        such individual may elect continuation coverage under 
        this title during the 60-day period that begins on the 
        first day of the month in which the individual becomes 
        a TAA-eligible individual, but only if such election is 
        made not later than 6 months after the date of the TAA-
        related loss of coverage.
            (2) Commencement of coverage; no reach-back.--Any 
        continuation coverage elected by a TAA-eligible 
        individual under paragraph (1) shall commence at the 
        beginning of the 60-day election period described in 
        such paragraph and shall not include any period prior 
        to such 60-day election period.
            (3) Preexisting conditions.--With respect to an 
        individual who elects continuation coverage pursuant to 
        paragraph (1), the period--
                    (A) beginning on the date of the TAA-
                related loss of coverage, and
                    (B) ending on the first day of the 60-day 
                election period described in paragraph (1),
        shall be disregarded for purposes of determining the 
        63-day periods referred to in section 2701(c)(2), 
        section 701(c)(2) of the Employee Retirement Income 
        Security Act of 1974, and section 9801(c)(2) of the 
        Internal Revenue Code of 1986.
            (4) Definitions.--For purposes of this subsection:
                    (A) Nonelecting taa-eligible individual.--
                The term ``nonelecting TAA-eligible 
                individual'' means a TAA-eligible individual 
                who--
                            (i) has a TAA-related loss of 
                        coverage; and
                            (ii) did not elect continuation 
                        coverage under this part during the 
                        TAA-related election period.
                    (B) TAA-eligible individual.--The term 
                ``TAA-eligible individual'' means--
                            (i) an eligible TAA recipient (as 
                        defined in paragraph (2) of section 
                        35(c) of the Internal Revenue Code of 
                        1986), and
                            (ii) an eligible alternative TAA 
                        recipient (as defined in paragraph (3) 
                        of such section).
                    (C) TAA-related election period.--The term 
                ``TAA-related election period'' means, with 
                respect to a TAA-related loss of coverage, the 
                60-day election period under this part which is 
                a direct consequence of such loss.
                    (D) TAA-related loss of coverage.--The term 
                ``TAA-related loss of coverage'' means, with 
                respect to an individual whose separation from 
                employment gives rise to being an TAA-eligible 
                individual, the loss of health benefits 
                coverage associated with such separation.

SEC. 2206. [300BB-6] NOTICE REQUIREMENTS.

    In accordance with regulations prescribed by the 
Secretary--
            (1) the group health plan shall provide, at the 
        time of commencement of coverage under the plan, 
        written notice to each covered employee and spouse of 
        the employee (if any) of the rights provided under this 
        subsection, \1\
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    \1\ So in law. Probably should be ``this title''.
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            (2) the employer of an employee under a plan must 
        notify the plan administrator of a qualifying event 
        described in paragraph (1), (2), or (4) of section 2203 
        within 30 days of the date of the qualifying event,
            (3) each covered employee or qualified beneficiary 
        is responsible for notifying the plan administrator of 
        the occurrence of any qualifying event described in 
        paragraph (3) or (5) of section 2203 within 60 days 
        after the date of the qualifying event and each 
        qualified beneficiary who is determined, under title II 
        or XVI of the Social Security Act, to have been 
        disabled at any time during the first 60 days of 
        continuation coverage under this title is responsible 
        for notifying the plan administrator of such 
        determination within 60 days after the date of the 
        determination and for notifying the plan administrator 
        within 30 days after the date of any final 
        determination under such title or titles that the 
        qualified beneficiary is no longer disabled, and
            (4) the plan administrator shall notify--
                    (A) in the case of a qualifying event 
                described in paragraph (1), (2), or (4) of 
                section 2203, any qualified beneficiary with 
                respect to such event, and
                    (B) in the case of a qualifying event 
                described in paragraph (3) or (5) of section 
                2203 where the covered employee notifies the 
                plan administrator under paragraph (3), any 
                qualified beneficiary with respect to such 
                event,
        of such beneficiary's rights under this subsection. \1\
For purposes of paragraph (4), any notification shall be made 
within 14 days of the date on which the plan administrator is 
notified under paragraph (2) or (3), whichever is applicable, 
and any such notification to an individual who is a qualified 
beneficiary as the spouse of the covered employee shall be 
treated as notification to all other qualified beneficiaries 
residing with such spouse at the time such notification is 
made.

SEC. 2207. \2\ [300bb-7] ENFORCEMENT.
    Any individual who is aggrieved by the failure of a State, 
political subdivision, or agency or instrumentality thereof, to 
comply with the requirements of this title may bring an action 
for appropriate equitable relief.
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    \2\ Section 13631(d) of Public Law 103-66 (107 Stat. 643) provides 
as follows:
    (d) Continued Coverage of Costs of a Pediatric Vaccine Under 
Certain Group Health Plans.--
---------------------------------------------------------------------------

          (1) Requirement.--The requirement of this paragraph, with 
        respect to a group health plan for plan years beginning after 
        the date of the enactment of this Act, is that the group health 
        plan not reduce its coverage of the costs of pediatric vaccines 
        (as defined under section 1928(h)(6) of the Social Security 
        Act) below the coverage it provided as of May 1, 1993.
          (2) Enforcement.--For purposes of section 2207 of the Public 
        Health Service Act, the requirement of paragraph (1) is deemed 
        a requirement of title XXII of such Act.

SEC. 2208. [300BB-8] DEFINITIONS.

    For purposes of this title--
            (1) Group health plan.--The term ``group health 
        plan'' has the meaning given such term in 5000(b) \1\ 
        of the Internal Revenue Code of 1986. Such term shall 
        not include any plan substantially all of the coverage 
        under which is for qualified long-term care services 
        (as defined in section 7702B(c) of such Code).
---------------------------------------------------------------------------
    \1\ So in law. The word ``section'' does not appear. See section 
102(d) of Public Law 104-191 (110 Stat. 1978).
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            (2) Covered employee.--The term ``covered 
        employee'' means an individual who is (or was) provided 
        coverage under a group health plan by virtue of the 
        performance of services by the individual for 1 or more 
        persons maintaining the plan (including as an employee 
        defined in section 401(c)(1) of the Internal Revenue 
        Code of 1986).
            (3) Qualified beneficiary.--
                    (A) In general.--The term ``qualified 
                beneficiary'' means, with respect to a covered 
                employee under a group health plan, any other 
                individual who, on the day before the 
                qualifying event for that employee, is a 
                beneficiary under the plan--
                            (i) as the spouse of the covered 
                        employee, or
                            (ii) as the dependent child of the 
                        employee.
        Such term shall also include a child who is born to or 
        placed for adoption with the covered employee during 
        the period of continuation coverage under this title. 
        \2\
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    \2\ Indentation is so in law. See section 401(a)(3) of Public Law 
104-191 (110 Stat. 2085).
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                    (B) Special rule for terminations and 
                reduced employment.--In the case of a 
                qualifying event described in section 2203(2), 
                the term ``qualified beneficiary'' includes the 
                covered employee.
            (4) Plan administrator.--The term ``plan 
        administrator'' has the meaning given the term 
        ``administrator'' by section 3(16)(A) of the Employee 
        Retirement Income Security Act of 1974.
 H1  deg.TITLE XXIII--RESEARCH WITH RESPECT TO ACQUIRED IMMUNE 
                        DEFICIENCY SYNDROME \1\
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    \1\ Subtitle E of title II of Public Law 100-607 (102 Stat. 3108) 
established various authorities regarding acquired immune deficiency 
syndrome.
     Section 2301 was repealed by section 104(b)(2)(C) of Public Law 
109-482.
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              Part A--Administration of Research Programs

 H4  deg.SEC. 2302. [300CC-1] REQUIREMENT OF EXPEDITING AWARDS 
                    OF GRANTS AND CONTRACTS FOR RESEARCH.

    (a) In General.--The Secretary shall expedite the award of 
grants, contracts, and cooperative agreements for research 
projects relating to acquired immune deficiency syndrome 
(including such research projects initiated independently of 
any solicitation by the Secretary for proposals for such 
research projects).
    (b) Time Limitations With Respect to Certain 
Applications.--
            (1) With respect to programs of grants, contracts, 
        and cooperative agreements described in subsection (a), 
        any application submitted in response to a solicitation 
        by the Secretary for proposals pursuant to such a 
        program--
                    (A) may not be approved if the application 
                is submitted after the expiration of the 3-
                month period beginning on the date on which the 
                solicitation is issued; and
                    (B) shall be awarded, or otherwise finally 
                acted upon, not later than the expiration of 
                the 6-month period beginning on the expiration 
                of the period described in subparagraph (A).
            (2) If the Secretary makes a determination that it 
        is not practicable to administer a program referred to 
        in paragraph (1) in accordance with the time 
        limitations described in such paragraph, the Secretary 
        may adjust the time limitations accordingly.
    (c) Requirements With Respect to Adjustments in Time 
Limitations.--With respect to any program for which a 
determination described in subsection (b)(2) is made, the 
Secretary shall--
            (1) if the determination is made before the 
        Secretary issues a solicitation for proposals pursuant 
        to the program, ensure that the solicitation describes 
        the time limitations as adjusted by the determination; 
        and
            (2) if the determination is made after the 
        Secretary issues such a solicitation for proposals, 
        issue a statement describing the time limitations as 
        adjusted by the determination and individually notify, 
        with respect to the determination, each applicant whose 
        application is submitted before the expiration of the 
        3-month period beginning on the date on which the 
        solicitation was issued.
    (d) Annual Reports to Congress.--Except as provided in 
subsection (e), the Secretary shall annually prepare, for 
inclusion in the comprehensive report required in section 2301, 
a report--
            (A) \1\ summarizing programs for which the 
        Secretary has made a determination described in 
        subsection (b)(2), including a description of the time 
        limitations as adjusted by the determination and 
        including a summary of the solicitation issued by the 
        Secretary for proposals pursuant to the program; and
---------------------------------------------------------------------------
    \1\ Designations are so in law. Subparagraphs (A) and (B) should 
probably be designated paragraphs (1) and (2), respectively. Similarly, 
clauses (i) and (ii) of subparagraph (B) should probably be designated 
subparagraphs (A) and (B), respectively.
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            (B) summarizing applications that--
                    (i) were submitted pursuant to a program of 
                grants, contracts, or cooperative agreements 
                referred to in paragraph (1) of subsection (b) 
                for which a determination described in 
                paragraph (2) of such subsection has not been 
                made; and
                    (ii) were not processed in accordance with 
                the time limitations described in such 
                paragraph (1).
    (e) Quarterly Reports for Fiscal Year 1989.--For fiscal 
year 1989, the report required in subsection (d) shall, not 
less than quarterly, be prepared and submitted to the Committee 
on Energy and Commerce of the House of Representatives and the 
Committee on Labor and Human Resources of the Senate.

SEC. 2303. [300CC-2] REQUIREMENTS WITH RESPECT TO PROCESSING OF 
                    REQUESTS FOR PERSONNEL AND ADMINISTRATIVE SUPPORT.

    (a) In General.--The Director of the Office of Personnel 
Management or the Administrator of General Services, as the 
case may be, shall respond to any priority request made by the 
Administrator of the Alcohol, Drug Abuse, and Mental Health 
Administration, the Director of the Centers for Disease Control 
and Prevention, the Commissioner of Food and Drugs, or the 
Director of the National Institutes of Health, not later than 
21 days after the date on which such request is made. If the 
Director of the Office of Personnel Management or the 
Administrator of General Services, as the case may be, does not 
disapprove a priority request during the 21-day period, the 
request shall be deemed to be approved.
    (b) Notice to Secretary and to Assistant Secretary for 
Health.--The Administrator of the Substance Abuse and Mental 
Health Services Administration, the Director of the Centers for 
Disease Control and Prevention, the Commissioner of Food and 
Drugs, and the Director of the National Institutes of Health, 
shall, respectively, transmit to the Secretary and the 
Assistant Secretary for Health a copy of each priority request 
made under this section by the agency head involved. The copy 
shall be transmitted on the date on which the priority request 
involved is made.
    (c) Definition of Priority Request.--For purposes of this 
section, the term ``priority request'' means any request that--
            (1) is designated as a priority request by the 
        Administrator of the Substance Abuse and Mental Health 
        Services Administration, the Director of the Centers 
        for Disease Control and Prevention, the Commissioner of 
        Food and Drugs, or the Director of the National 
        Institutes of Health; and
            (2)(A) is made to the Director of the Office of 
        Personnel Management for the allocation of personnel to 
        carry out activities with respect to acquired immune 
        deficiency syndrome; or
            (B) is made to the Administrator of General 
        Services for administrative support or space in 
        carrying out such activities.

SEC. 2304. [300CC-3] ESTABLISHMENT OF RESEARCH ADVISORY COMMITTEE.

    (a) In General.--After consultation with the Commissioner 
of Food and Drugs, the Secretary, acting through the Director 
of the National Institute of Allergy and Infectious Diseases, 
shall establish within such Institute an advisory committee to 
be known as the AIDS Research Advisory Committee (hereafter in 
this section referred to as the ``Committee'').
    (b) Composition.--The Committee shall be composed of 
physicians whose clinical practice includes a significant 
number of patients with acquired immune deficiency syndrome.
    (c) Duties.--The Committee shall--
            (1) advise the Director of such Institute (and may 
        provide advice to the Directors of other agencies of 
        the National Institutes of Health, as appropriate) on 
        appropriate research activities to be undertaken with 
        respect to clinical treatment of such syndrome, 
        including advice with respect to--
                    (A) research on drugs for preventing or 
                minimizing the development of symptoms or 
                conditions arising from infection with the 
                etiologic agent for such syndrome, including 
                recommendations on the projects of research 
                with respect to diagnosing immune deficiency 
                and with respect to predicting, diagnosing, 
                preventing, and treating opportunistic cancers 
                and infectious diseases; and
                    (B) research on the effectiveness of 
                treating such symptoms or conditions with drugs 
                that--
                            (i) are not approved by the 
                        Commissioner of Food and Drugs for the 
                        purpose of treating such symptoms or 
                        conditions; and
                            (ii) are being utilized for such 
                        purpose by individuals infected with 
                        such etiologic agent;
            (2)(A) review ongoing publicly and privately 
        supported research on clinical treatment for acquired 
        immune deficiency syndrome, including research on drugs 
        described in paragraph (1); and
            (B) periodically issue, and make available to 
        health care professionals, reports describing and 
        evaluating such research;
            (3) conduct studies and convene meetings for the 
        purpose of determining the recommendations among 
        physicians in clinical practice on clinical treatment 
        of acquired immune deficiency syndrome, including 
        treatment with the drugs described in paragraph (1); 
        and
            (4) conduct a study for the purpose of developing, 
        with respect to individuals infected with the etiologic 
        agent for acquired immune deficiency syndrome, a 
        consensus among health care professionals on clinical 
        treatments for preventing or minimizing the development 
        of symptoms or conditions arising from infection with 
        such etiologic agent.

               H2  deg.Part B--Research Authority

SEC. 2311. [300CC-11] CLINICAL EVALUATION UNITS AT NATIONAL INSTITUTES 
                    OF HEALTH.

    (a) In General.--The Secretary, acting through the Director 
of the National Cancer Institute and the Director of the 
National Institute of Allergy and Infectious Diseases, shall 
for each such Institute establish a clinical evaluation unit at 
the Clinical Center at the National Institutes of Health. Each 
of the clinical evaluation units--
            (1) shall conduct clinical evaluations of 
        experimental treatments for acquired immune deficiency 
        syndrome developed within the preclinical drug 
        development program, including evaluations of methods 
        of diagnosing immune deficiency and evaluations of 
        methods of predicting, diagnosing, preventing, and 
        treating opportunistic cancers and infectious diseases; 
        and
            (2) may conduct clinical evaluations of 
        experimental treatments for such syndrome that are 
        developed by any other national research institute of 
        the National Institutes of Health or by any other 
        entity.
    (b) Personnel and Administrative Support.--
            (1) For the purposes described in subsection (a), 
        the Secretary, acting through the Director of the 
        National Institutes of Health, shall provide each of 
        the clinical evaluation units required in such 
        subsection--
                    (A)(i) with not less than 50 beds; or
                    (ii) with an outpatient clinical capacity 
                equal to not less than twice the outpatient 
                clinical capacity, with respect to acquired 
                immune deficiency syndrome, possessed by the 
                Clinical Center of the National Institutes of 
                Health on June 1, 1988; and
                    (B) with such personnel, such 
                administrative support, and such other support 
                services as may be necessary.
            (2) Facilities, personnel, administrative support, 
        and other support services provided pursuant to 
        paragraph (1) shall be in addition to the number or 
        level of facilities, personnel, administrative support, 
        and other support services that otherwise would be 
        available at the Clinical Center at the National 
        Institutes of Health for the provision of clinical care 
        for individuals with diseases or disorders.
    (c) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary.

 H4  deg.SEC. 2312. [300CC-12] USE OF INVESTIGATIONAL NEW 
                    DRUGS WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY 
                    SYNDROME.

    (a) Encouragement of Applications With Respect to Clinical 
Trials.--
            (1) If, in the determination of the Secretary, 
        there is preliminary evidence that a new drug has 
        effectiveness in humans with respect to the prevention 
        or treatment of acquired immune deficiency syndrome, 
        the Secretary shall, through statements published in 
        the Federal Register--
                    (A) announce the fact of such 
                determination; and
                    (B) with respect to the new drug involved, 
                encourage an application for an exemption for 
                investigational use of the new drug under 
                regulations issued under section 505(i) of the 
                Federal Food, Drug, and Cosmetic Act.
            (2)(A) The AIDS Research Advisory Committee 
        established pursuant to section 2304 shall make 
        recommendations to the Secretary with respect to new 
        drugs appropriate for determinations described in 
        paragraph (1).
            (B) The Secretary shall, as soon as is practicable, 
        determine the merits of recommendations received by the 
        Secretary pursuant to subparagraph (A).
    (b) Encouragement of Applications With Respect to Treatment 
Use in Circumstances Other Than Clinical Trials.--
            (1) In the case of a new drug with respect to which 
        the Secretary has made a determination described in 
        subsection (a) and with respect to which an exemption 
        is in effect for purposes of section 505(i) of the 
        Federal Food, Drug, and Cosmetic Act, the Secretary 
        shall--
                    (A) as appropriate, encourage the sponsor 
                of the investigation of the new drug to submit 
                to the Secretary, in accordance with 
                regulations issued under such section, an 
                application to use the drug in the treatment of 
                individuals--
                            (i) who are infected with the 
                        etiologic agent for acquired immune 
                        deficiency syndrome; and
                            (ii) who are not participating in 
                        the clinical trials conducted pursuant 
                        to such exemption; and
                    (B) if such an application is approved, 
                encourage, as appropriate, licensed medical 
                practitioners to obtain, in accordance with 
                such regulations, the new drug from such 
                sponsor for the purpose of treating such 
                individuals.
            (2) If the sponsor of the investigation of a new 
        drug described in paragraph (1) does not submit to the 
        Secretary an application described in such paragraph 
        (relating to treatment use), the Secretary shall, 
        through statements published in the Federal Register, 
        encourage, as appropriate, licensed medical 
        practitioners to submit to the Secretary such 
        applications in accordance with regulations described 
        in such paragraph.
    (c) Technical Assistance With Respect to Treatment Use.--In 
the case of a new drug with respect to which the Secretary has 
made a determination described in subsection (a), the Secretary 
may, directly or through grants or contracts, provide technical 
assistance with respect to the process of--
            (1) submitting to the Secretary applications for 
        exemptions described in paragraph (1)(B) of such 
        subsection;
            (2) submitting to the Secretary applications 
        described in subsection (b); and
            (3) with respect to sponsors of investigations of 
        new drugs, facilitating the transfer of new drugs from 
        such sponsors to licensed medical practitioners.
    (d) Definition.--For purposes of this section, the term 
``new drug'' has the meaning given such term in section 201 of 
the Federal Food, Drug, and Cosmetic Act.

 H4  deg.SEC. 2313. [300CC-13] TERRY BEIRN COMMUNITY-BASED 
                    AIDS RESEARCH INITIATIVE.

    (a) In General.--After consultation with the Commissioner 
of Food and Drugs, the Director of the National Institutes of 
Health, acting through the National Institute \1\ of Allergy 
and Infectious Diseases, may make grants to public entities and 
nonprofit private entities concerned with acquired immune 
deficiency syndrome, and may enter into contracts with public 
and private such entities, for the purpose of planning and 
conducting, in the community involved, clinical trials of 
experimental treatments for infection with the etiologic agent 
for such syndrome that are approved by the Commissioner of Food 
and Drugs for investigational use under regulations issued 
under section 505 of the Federal Food, Drug, and Cosmetic Act.
---------------------------------------------------------------------------
    \1\ So in law. Probably should be ``acting through the Director of 
the National Institute''. (Section 2617(b)(1) of Public Law 100-690 
expressed the intent to so amend the provision; however, the amendment 
cannot be executed because the amendatory instructions are to strike 
``through the National Institutes of Allergy'', and this term does not 
appear in subsection (a) (above).)
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    (b) Requirement of Certain Projects.--
            (1) Financial assistance under subsection (a) shall 
        include such assistance to community-based 
        organizations and community health centers for the 
        purpose of--
                    (A) retaining appropriate medical 
                supervision;
                    (B) assisting with administration, data 
                collection and record management; and
                    (C) conducting training of community 
                physicians, nurse practitioners, physicians' 
                assistants and other health professionals for 
                the purpose of conducting clinical trials.
            (2)(A) Financial assistance under subsection (a) 
        shall include such assistance for demonstration 
        projects designed to implement and conduct community-
        based clinical trials in order to provide access to the 
        entire scope of communities affected by infections with 
        the etiologic agent for acquired immune deficiency 
        syndrome, including minorities, hemophiliacs and 
        transfusion-exposed individuals, women, children, users 
        of intravenous drugs, and individuals who are 
        asymptomatic with respect to such infection.
            (B) The Director of the National Institutes of 
        Health may not provide financial assistance under this 
        paragraph unless the application for such assistance is 
        approved--
                    (i) by the Commissioner of Food and Drugs;
                    (ii) by a duly constituted Institutional 
                Review Board that meets the requirements of 
                part 56 of title 21, Code of Federal 
                Regulations; and
                    (iii) by the Director of the National 
                Institute of Allergy and Infectious Diseases.
    (c) Participation of Private Industry, Schools of Medicine 
and Primary Providers.--Programs carried out with financial 
assistance provided under subsection (a) shall be designed to 
encourage private industry and schools of medicine, osteopathic 
medicine, and existing consortia of primary care providers 
organized to conduct clinical research concerning acquired 
immune deficiency syndrome to participate in, and to support, 
the clinical trials conducted pursuant to the programs.
    (d) Requirement of Application.--The Secretary may not 
provide financial assistance under subsection (a) unless--
            (1) an application for the assistance is submitted 
        to the Secretary;
            (2) with respect to carrying out the purpose for 
        which the assistance is to be made, the application 
        provides assurances of compliance satisfactory to the 
        Secretary; and
            (3) the application otherwise is in such form, is 
        made in such manner, and contains such agreements, 
        assurances, and information as the Secretary determines 
        to be necessary to carry out this section.
    (e) Authorization of Appropriations.--
            (1) For the purpose of carrying out subsection 
        (b)(1), there are authorized to be appropriated such 
        sums as may be necessary for each of the fiscal years 
        1989 through 1996.
            (2) For the purpose of carrying out subsection 
        (b)(2), there are authorized to be appropriated such 
        sums as may be necessary for each of the fiscal years 
        1989 through 1996.

SEC. 2314. [300CC-14] EVALUATION OF CERTAIN TREATMENTS.

    (a) Establishment of Program.--
            (1) After consultation with the AIDS Research 
        Advisory Committee established pursuant to section 
        2304, the Secretary shall establish a program for the 
        evaluation of drugs that--
                    (A) are not approved by the Commissioner of 
                Food and Drugs for the purpose of treatments 
                with respect to acquired immune deficiency 
                syndrome; and
                    (B) are being utilized for such purpose by 
                individuals infected with the etiologic agent 
                for such syndrome.
            (2) The program established under paragraph (1) 
        shall include evaluations of the effectiveness and the 
        risks of the treatment involved, including the risks of 
        foregoing treatments with respect to acquired immune 
        deficiency syndrome that are approved by the 
        Commissioner of Food and Drugs.
    (b) Authority With Respect to Grants and Contracts.--
            (1) For the purpose of conducting evaluations 
        required in subsection (a), the Secretary may make 
        grants to, and enter into cooperative agreements and 
        contracts with, public and nonprofit private entities.
            (2) Nonprofit private entities under paragraph (1) 
        may include nonprofit private organizations that--
                    (A) are established for the purpose of 
                evaluating treatments with respect to acquired 
                immune deficiency syndrome; and
                    (B) consist primarily of individuals 
                infected with the etiologic agent for such 
                syndrome.
    (c) Scientific and Ethical Guidelines.--
            (1) The Secretary shall establish appropriate 
        scientific and ethical guidelines for the conduct of 
        evaluations carried out pursuant to this section. The 
        Secretary may not provide financial assistance under 
        subsection (b)(1) unless the applicant for such 
        assistance agrees to comply with such guidelines.
            (2) The Secretary may establish the guidelines 
        described in paragraph (1) only after consulting with--
                    (A) physicians whose clinical practice 
                includes a significant number of individuals 
                with acquired immune deficiency syndrome;
                    (B) individuals who are infected with the 
                etiologic agent for such syndrome; and
                    (C) other individuals with appropriate 
                expertise or experience.
    (d) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary.

SEC. 2315. [300CC-15] SUPPORT OF INTERNATIONAL EFFORTS.

    (a) Grants and Contracts for Research.--
            (1) Under section 307, the Secretary, acting 
        through the Director of the National Institutes of 
        Health--
                    (A) shall, for the purpose described in 
                paragraph (2), make grants to, enter into 
                cooperative agreements and contracts with, and 
                provide technical assistance to, international 
                organizations concerned with public health; and
                    (B) may, for such purpose, provide 
                technical assistance to foreign governments.
            (2) The purpose referred to in paragraph (1) is 
        promoting and expediting international research and 
        training concerning the natural history and 
        pathogenesis of the human immunodeficiency virus and 
        the development and evaluation of vaccines and 
        treatments for acquired immune deficiency syndrome and 
        opportunistic infections.
    (b) Grants and Contracts for Additional Purposes.--After 
consultation with the Administrator of the Agency for 
International Development, the Secretary, acting through the 
Director of the Centers for Disease Control and Prevention, 
shall under section 307 make grants to, enter into contracts 
with, and provide technical assistance to, international 
organizations concerned with public health and may provide 
technical assistance to foreign governments, in order to 
support--
            (1) projects for training individuals with respect 
        to developing skills and technical expertise for use in 
        the prevention, diagnosis, and treatment of acquired 
        immune deficiency syndrome; and
            (2) epidemiological research relating to acquired 
        immune deficiency syndrome.
    (c) Special Programme of World Health Organization.--
Support provided by the Secretary pursuant to this section 
shall be in furtherance of the global strategy of the World 
Health Organization Special Programme on Acquired 
Immunodeficiency Syndrome.
    (d) Preferences.--In providing grants, cooperative 
agreements, contracts, and technical assistance under 
subsections (a) and (b), the Secretary shall--
            (1) give preference to activities under such 
        subsections conducted by, or in cooperation with, the 
        World Health Organization; and
            (2) with respect to activities carried out under 
        such subsections in the Western Hemisphere, give 
        preference to activities conducted by, or in 
        cooperation with, the Pan American Health Organization 
        or the World Health Organization.
    (e) Requirement of Application.--The Secretary may not make 
a grant or enter into a cooperative agreement or contract under 
this section unless--
            (1) an application for such assistance is submitted 
        to the Secretary;
            (2) with respect to carrying out the purpose for 
        which such assistance is to be provided, the 
        application provides assurances of compliance 
        satisfactory to the Secretary; and
            (3) the application otherwise is in such form, is 
        made in such manner, and contains such agreements, 
        assurances, and information as the Secretary determines 
        to be necessary to carry out this section.
    (f) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each fiscal 
year.

SEC. 2316. [300CC-16] RESEARCH CENTERS.

    (a) In General.--
            (1) The Secretary, acting through the Director of 
        the National Institute of Allergy and Infectious 
        Diseases, may make grants to, and enter into contracts 
        with, public and nonprofit private entities to assist 
        such entities in planning, establishing, or 
        strengthening, and providing basic operating support 
        for, centers for basic and clinical research into, and 
        training in, advanced diagnostic, prevention, and 
        treatment methods for acquired immune deficiency 
        syndrome.
            (2) A grant or contract under paragraph (1) shall 
        be provided in accordance with policies established by 
        the Secretary, acting through the Director of the 
        National Institutes of Health, and after consultation 
        with the advisory council for the National Institute of 
        Allergy and Infectious Diseases.
            (3) The Secretary shall ensure that, as 
        appropriate, clinical research programs carried out 
        under paragraph (1) include as research subjects women, 
        children, hemophiliacs, and minorities.
    (b) Use of Financial Assistance.--
            (1) Financial assistance under subsection (a) may 
        be expended for--
                    (A) the renovation or leasing of space;
                    (B) staffing and other basic operating 
                costs, including such patient care costs as are 
                required for clinical research;
                    (C) clinical training with respect to 
                acquired immune deficiency syndrome (including 
                such training for allied health professionals); 
                and
                    (D) demonstration purposes, including 
                projects in the long-term monitoring and 
                outpatient treatment of individuals infected 
                with the etiologic agent for such syndrome.
            (2) Financial assistance under subsection (a) may 
        not be expended to provide research training for which 
        National Research Service Awards may be provided under 
        section 487.
    (c) Duration of Support.--Support of a center under 
subsection (a) may be for not more than five years. Such period 
may be extended by the Director for additional periods of not 
more than five years each if the operations of such center have 
been reviewed by an appropriate technical and scientific peer 
review group established by the Director and if such group has 
recommended to the Director that such period should be 
extended.
    (d) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary.

SEC. 2317. [300CC-17] INFORMATION SERVICES.

    (a) Establishment of Program.--The Secretary shall 
establish, maintain, and operate a program with respect to 
information on research, treatment, and prevention activities 
relating to infection with the etiologic agent for acquired 
immune deficiency syndrome. The program shall, with respect to 
the agencies of the Department of Health and Human Services, be 
integrated and coordinated.
    (b) Toll-Free Telephone Communications for Health Care 
Entities.--
            (1) After consultation with the Director of the 
        Office of AIDS Research, the Administrator of the 
        Health Resources and Services Administration, and the 
        Director of the Centers for Disease Control and 
        Prevention, the Secretary shall provide for toll-free 
        telephone communications to provide medical and 
        technical information with respect to acquired immune 
        deficiency syndrome to health care professionals, 
        allied health care providers, and to professionals 
        providing emergency health services.
            (2) Information provided pursuant to paragraph (1) 
        shall include--
                    (A) information on prevention of exposure 
                to, and the transmission of, the etiologic 
                agent for acquired immune deficiency syndrome; 
                and
                    (B) information contained in the data banks 
                established in subsections (c) and (d).
    (c) Data Bank on Research Information.--
            (1) After consultation with the Director of the 
        Office of AIDS Research, the Director of the Centers 
        for Disease Control and Prevention, and the National 
        Library of Medicine, the Secretary shall establish a 
        data bank of information on the results of research 
        with respect to acquired immune deficiency syndrome 
        conducted in the United States and other countries.
            (2) In carrying out paragraph (1), the Secretary 
        shall collect, catalog, store, and disseminate the 
        information described in such paragraph. To the extent 
        practicable, the Secretary shall make such information 
        available to researchers, physicians, and other 
        appropriate individuals, of countries other than the 
        United States.
    (d) Data Bank on Clinical Trials and Treatments.--
            (1) After consultation with the Commissioner of 
        Food and Drugs, the AIDS Research Advisory Committee 
        established under section 2304, and the Director of the 
        Office of AIDS Research, the Secretary shall, in 
        carrying out subsection (a), establish a data bank of 
        information on clinical trials and treatments with 
        respect to infection with the etiologic agent for 
        acquired immune deficiency syndrome (hereafter in this 
        section referred to as the ``Data Bank'').
            (2) In carrying out paragraph (1), the Secretary 
        shall collect, catalog, store, and disseminate the 
        information described in such paragraph. The Secretary 
        shall disseminate such information through information 
        systems available to individuals infected with the 
        etiologic agent for acquired immune deficiency 
        syndrome, to other members of the public, to health 
        care providers, and to researchers.
    (e) Requirements With Respect to Data Bank on Clinical 
Trials and Treatments.--The Data Bank shall include the 
following:
            (1) A registry of clinical trials of experimental 
        treatments for acquired immune deficiency syndrome and 
        related illnesses conducted under regulations 
        promulgated pursuant to section 505 of the Federal 
        Food, Drug and Cosmetic Act that provides a description 
        of the purpose of each experimental drug protocol 
        either with the consent of the protocol sponsor, or 
        when a trial to test efficacy begins. Information 
        provided shall include eligibility criteria and the 
        location of trial sites, and must be forwarded to the 
        Data Bank by the sponsor of the trial not later than 21 
        days after the approval by the Food and Drug 
        Administration.
            (2) Information pertaining to experimental 
        treatments for acquired immune deficiency syndrome that 
        may be available under a treatment investigational new 
        drug application that has been submitted to the Food 
        and Drug Administration pursuant to part 312 of title 
        21, Code of Federal Regulations. The Data Bank shall 
        also include information pertaining to the results of 
        clinical trials of such treatments, with the consent of 
        the sponsor, of such experimental treatments, including 
        information concerning potential toxicities or adverse 
        effects associated with the use or administration of 
        such experimental treatment.

SEC. 2318. [300CC-18] DEVELOPMENT OF MODEL PROTOCOLS FOR CLINICAL CARE 
                    OF INFECTED INDIVIDUALS.

    (a) In General.--
            (1) The Secretary, acting through the Director of 
        the National Institutes of Health and after 
        consultation with the Administrator for Health Care 
        Policy and Research, may make grants to public and 
        nonprofit private entities for the establishment of 
        projects to develop model protocols for the clinical 
        care of individuals infected with the etiologic agent 
        for acquired immune deficiency syndrome, including 
        treatment and prevention of HIV infection and related 
        conditions among women.
            (2) The Secretary may not make a grant under 
        paragraph (1) unless--
                    (A) the applicant for the grant is a 
                provider of comprehensive primary care; or
                    (B) the applicant for the grant agrees, 
                with respect to the project carried out 
                pursuant to paragraph (1), to enter into a 
                cooperative arrangement with an entity that is 
                a provider of comprehensive primary care.
    (b) Requirement of Provision of Certain Services.--The 
Secretary may not make a grant under subsection (a) unless the 
applicant for the grant agrees that, with respect to patients 
participating in the project carried out with the grant, 
services provided pursuant to the grant will include--
            (1) monitoring, in clinical laboratories, of the 
        condition of such patients;
            (2) clinical intervention for infection with the 
        etiologic agent for acquired immune deficiency 
        syndrome, including measures for the prevention of 
        conditions arising from the infection;
            (3) information and counseling on the availability 
        of treatments for such infection approved by the 
        Commissioner of Food and Drugs, on the availability of 
        treatments for such infection not yet approved by the 
        Commissioner, and on the reports issued by the AIDS 
        Research Advisory Committee under section 
        2304(c)(2)(B);
            (4) support groups; and
            (5) information on, and referrals to, entities 
        providing appropriate social support services.
    (c) Limitation on Imposition of Charges for Services.--The 
Secretary may not make a grant under subsection (a) unless the 
applicant for the grant agrees that, if the applicant will 
routinely impose a charge for providing services pursuant to 
the grant, the applicant will not impose the charge on any 
individual seeking such services who is unable to pay the 
charge.
    (d) Evaluation and Reports.--
            (1) The Secretary may not make a grant under 
        subsection (a) unless the applicant for the grant 
        agrees, with respect to the project carried out 
        pursuant to subsection (a), to submit to the 
        Secretary--
                    (A) information sufficient to assist in the 
                replication of the model protocol developed 
                pursuant to the project; and
                    (B) such reports as the Secretary may 
                require.
            (2) The Secretary shall provide for evaluations of 
        projects carried out pursuant to subsection (a) and 
        shall annually submit to the Congress a report 
        describing such projects. The report shall include the 
        findings made as a result of such evaluations and may 
        include any recommendations of the Secretary for 
        appropriate administrative and legislative initiatives 
        with respect to the program established in this 
        section.
    (e) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 1989 through 1991, and such sums as may be 
necessary for each of the fiscal years 1994 through 1996.

 H4  deg.SEC. 2319. [300CC-19] NATIONAL BLOOD RESOURCE 
                    EDUCATION PROGRAM.

    After consultation with the Director of the National Heart, 
Lung, and Blood Institute and the Commissioner of Food and 
Drugs, the Secretary shall establish a program of research and 
education regarding blood donations and transfusions to 
maintain and improve the safety of the blood supply. Education 
programs shall be directed at health professionals, patients, 
and the community to--
            (1) in the case of the public and patients 
        undergoing treatment--
                    (A) increase awareness that the process of 
                donating blood is safe;
                    (B) promote the concept that blood donors 
                are contributors to a national need to maintain 
                an adequate and safe blood supply;
                    (C) encourage blood donors to donate more 
                than once a year; and
                    (D) encourage repeat blood donors to 
                recruit new donors;
            (2) in the case of health professionals--
                    (A) improve knowledge, attitudes, and 
                skills of health professionals in the 
                appropriate use of blood and blood components;
                    (B) increase the awareness and 
                understanding of health professionals regarding 
                the risks versus benefits of blood transfusion; 
                and
                    (C) encourage health professionals to 
                consider alternatives to the administration of 
                blood or blood components for their patients; 
                and
            (3) in the case of the community, increase 
        coordination, communication, and collaboration among 
        community, professional, industry, and government 
        organizations regarding blood donation and transfusion 
        issues.

SEC. 2320. [300CC-20] ADDITIONAL AUTHORITY WITH RESPECT TO RESEARCH.

    (a) Data Collection With Respect to National Prevalence.--
            (1) The Secretary, acting through the Director of 
        the Centers for Disease Control and Prevention, may, 
        through representative sampling and other appropriate 
        methodologies, provide for the continuous collection of 
        data on the incidence in the United States of cases of 
        acquired immune deficiency syndrome and of cases of 
        infection with the etiologic agent for such syndrome. 
        The Secretary may carry out the program of data 
        collection directly or through cooperative agreements 
        and contracts with public and nonprofit private 
        entities.
            (2) The Secretary shall encourage each State to 
        enter into a cooperative agreement or contract under 
        paragraph (1) with the Secretary in order to facilitate 
        the prompt collection of the most recent accurate data 
        on the incidence of cases described in such paragraph.
            (3) The Secretary shall ensure that data collected 
        under paragraph (1) includes data on the demographic 
        characteristics of the population of individuals with 
        cases described in paragraph (1), including data on 
        specific subpopulations at risk of infection with the 
        etiologic agent for acquired immune deficiency 
        syndrome.
            (4) In carrying out this subsection, the Secretary 
        shall, for the purpose of assuring the utility of data 
        collected under this section, request entities with 
        expertise in the methodologies of data collection to 
        provide, as soon as is practicable, assistance to the 
        Secretary and to the States with respect to the 
        development and utilization of uniform methodologies of 
        data collection.
            (5) The Secretary shall provide for the 
        dissemination of data collected pursuant to this 
        subsection. In carrying out this paragraph, the 
        Secretary may publish such data as frequently as the 
        Secretary determines to be appropriate with respect to 
        the protection of the public health. The Secretary 
        shall publish such data not less than once each year.
    (b) Epidemiological and Demographic Data.--
            (1) The Secretary, acting through the Director of 
        the Centers for Disease Control and Prevention, shall 
        develop an epidemiological data base and shall provide 
        for long-term studies for the purposes of--
                    (A) collecting information on the 
                demographic characteristics of the population 
                of individuals infected with the etiologic 
                agent for acquired immune deficiency syndrome 
                and the natural history of such infection; and
                    (B) developing models demonstrating the 
                long-term domestic and international patterns 
                of the transmission of such etiologic agent.
            (2) The Secretary may carry out paragraph (1) 
        directly or through grants to, or cooperative 
        agreeements 1 or contracts with, public and 
        nonprofit private entities, including Federal agencies.
---------------------------------------------------------------------------
    \1\ So in law. Probably should be ``agreements''.
---------------------------------------------------------------------------
    (c) Long-Term Research.--The Secretary may make grants to 
public and nonprofit private entities for the purpose of 
assisting grantees in conducting long-term research into 
treatments for acquired immune deficiency syndrome developed 
from knowledge of the genetic nature of the etiologic agent for 
such syndrome.
    (d) Social Sciences Research.--The Secretary, acting 
through the Director of the National Institute of Mental 
Health, may make grants to public and nonprofit private 
entities for the purpose of assisting grantees in conducting 
scientific research into the psychological and social sciences 
as such sciences relate to acquired immune deficiency syndrome.
    (e) Authorization of Appropriations.--
            (1) For the purpose of carrying out this section, 
        there are authorized to be appropriated such sums as 
        may be necessary for each fiscal year.
            (2) Amounts appropriated pursuant to paragraph (1) 
        to carry out subsection (c) shall remain available 
        until expended.

               H2  deg.Part C--Research Training

SEC. 2341. [300CC-31] FELLOWSHIPS AND TRAINING.

    (a) In General.--The Secretary, acting through the Director 
of the Centers for Disease Control \2\, shall establish 
fellowship and training programs to be conducted by the Centers 
for Disease Control \2\ to train individuals to develop skills 
in epidemiology, surveillance, testing, counseling, education, 
information, and laboratory analysis relating to acquired 
immune deficiency syndrome. Such programs shall be designed to 
enable health professionals and health personnel trained under 
such programs to work, after receiving such training, in 
national and international efforts toward the prevention, 
diagnosis, and treatment of acquired immune deficiency 
syndrome.
---------------------------------------------------------------------------
    \2\ So in law. Section 312(d)(21) of Public Law 102-531 (106 Stat. 
3505) provided that section 2341(a) is amended by striking ``Centers 
for Disease Control'' and inserting ``Centers for Disease Control and 
Prevention''. The amendment cannot be executed because it does not 
specify to which of the instances of such term the amendment applies.
---------------------------------------------------------------------------
    (b) Programs Conducted by National Institute of Mental 
Health.--The Secretary, acting through the Director of the 
National Institute of Mental Health, shall conduct or support 
fellowship and training programs for individuals pursuing 
graduate or postgraduate study in order to train such 
individuals to conduct scientific research into the 
psychological and social sciences as such sciences relate to 
acquired immune deficiency syndrome.
    (c) Relationship to Limitation on Number of Employees.--Any 
individual receiving a fellowship or receiving training under 
subsection (a) or (b) shall not be included in any 
determination of the number of full-time equivalent employees 
of the Department of Health and Human Services for the purpose 
of any limitation on the number of such employees established 
by law prior to, on, or after the date of the enactment of the 
AIDS Amendments of 1988.
    (d) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each fiscal 
year.

                    Part D--Office of AIDS Research

           Subpart I--Interagency Coordination of Activities

SEC. 2351. [300CC-40] ESTABLISHMENT OF OFFICE.

    (a) In General.--There is established within the National 
Institutes of Health an office to be known as the Office of 
AIDS Research. The Office shall be headed by a director, who 
shall be appointed by the Secretary.
    (b) Duties.--
            (1) Interagency coordination of aids activities.--
        With respect to acquired immune deficiency syndrome, 
        the Director of the Office shall plan, coordinate, and 
        evaluate research and other activities conducted or 
        supported by the agencies of the National Institutes of 
        Health. In carrying out the preceding sentence, the 
        Director of the Office shall evaluate the AIDS 
        activities of each of such agencies and shall provide 
        for the periodic reevaluation of such activities.
            (2) Consultations.--The Director of the Office 
        shall carry out this subpart (including developing and 
        revising the plan required in section 2353) in 
        consultation with the heads of the agencies of the 
        National Institutes of Health, with the advisory 
        councils of the agencies, and with the advisory council 
        established under section 2352.
            (3) Coordination.--The Director of the Office shall 
        act as the primary Federal official with responsibility 
        for overseeing all AIDS research conducted or supported 
        by the National Institutes of Health, and
                    (A) shall serve to represent the National 
                Institutes of Health AIDS Research Program at 
                all relevant Executive branch task forces and 
                committees; and
                    (B) shall maintain communications with all 
                relevant Public Health Service agencies and 
                with various other departments of the Federal 
                Government, to ensure the timely transmission 
                of information concerning advances in AIDS 
                research and the clinical treatment of acquired 
                immune deficiency syndrome and its related 
                conditions, between these various agencies for 
                dissemination to affected communities and 
                health care providers.

SEC. 2351A. [300CC-40A] MICROBICIDE RESEARCH.

    (a) Federal Strategic Plan.--The Director of the Office 
shall--
            (1) expedite the implementation of the Federal 
        strategic plans required by section 403(a) of the 
        Public Health Service Act (42 U.S.C. 283(a)(5)) 
        regarding the conduct and support of research on, and 
        development of, a microbicide to prevent the 
        transmission of the human immunodeficiency virus; and
            (2) review and, as appropriate, revise such plan to 
        prioritize funding and activities relative to their 
        scientific urgency and potential market readiness.
    (b) Coordination.--In implementing, reviewing, and 
prioritizing elements of the plan described in subsection (a), 
the Director of the Office shall consult, as appropriate, 
with--
            (1) representatives of other Federal agencies 
        involved in microbicide research, including the 
        Coordinator of United States Government Activities to 
        Combat HIV/AIDS Globally, the Director of the Centers 
        for Disease Control and Prevention, and the 
        Administrator of the United States Agency for 
        International Development;
            (2) the microbicide research and development 
        community; and
            (3) health advocates.

SEC. 2352. [300CC-40A] ADVISORY COUNCIL; COORDINATING COMMITTEES.

    (a) Advisory Council.--
            (1) In general.--The Secretary shall establish an 
        advisory council for the purpose of providing advice to 
        the Director of the Office on carrying out this part. 
        (Such council is referred to in this subsection as the 
        ``Advisory Council''.)
            (2) Composition, compensation, terms, chair, etc.--
        Subsections (b) through (g) of section 406 apply to the 
        Advisory Council to the same extent and in the same 
        manner as such subsections apply to advisory councils 
        for the national research institutes, except that--
                    (A) in addition to the ex officio members 
                specified in section 406(b)(2), there shall 
                serve as such members of the Advisory Council a 
                representative from the advisory council of 
                each of the National Cancer Institute and the 
                National Institute on Allergy and Infectious 
                Diseases; and
                    (B) with respect to the other national 
                research institutes, there shall serve as ex 
                officio members of such Council, in addition to 
                such members specified in subparagraph (A), a 
                representative from the advisory council of 
                each of the 2 institutes that receive the 
                greatest funding for AIDS activities.
    (b) Individual Coordinating Committees Regarding Research 
Disciplines.--
            (1) In general.--The Director of the Office shall 
        establish, for each research discipline in which any 
        activity under the plan required in section 2353 is 
        carried out, a committee for the purpose of providing 
        advice to the Director of the Office on carrying out 
        this part with respect to such discipline. (Each such 
        committee is referred to in this subsection as a 
        ``coordinating committee''.)
            (2) Composition.--Each coordinating committee shall 
        be composed of representatives of the agencies of the 
        National Institutes of Health with significant 
        responsibilities regarding the research discipline 
        involved.

SEC. 2353. [300CC-40B] COMPREHENSIVE PLAN FOR EXPENDITURE OF 
                    APPROPRIATIONS.

    (a) In General.--Subject to the provisions of this section 
and other applicable law, the Director of the Office, in 
carrying out section 2351, shall--
            (1) establish a comprehensive plan for the conduct 
        and support of all AIDS activities of the agencies of 
        the National Institutes of Health (which plan shall be 
        first established under this paragraph not later than 
        12 months after the date of the enactment of the 
        National Institutes of Health Revitalization Act of 
        1993); \1\
---------------------------------------------------------------------------
    \1\ Enacted June 10, 1993.
---------------------------------------------------------------------------
            (2) ensure that the Plan establishes priorities 
        among the AIDS activities that such agencies are 
        authorized to carry out;
            (3) ensure that the Plan establishes objectives 
        regarding such activities, describes the means for 
        achieving the objectives, and designates the date by 
        which the objectives are expected to be achieved;
            (4) ensure that all amounts appropriated for such 
        activities are expended in accordance with the Plan;
            (5) review the Plan not less than annually, and 
        revise the Plan as appropriate; and
            (6) ensure that the Plan serves as a broad, binding 
        statement of policies regarding AIDS activities of the 
        agencies, but does not remove the responsibility of the 
        heads of the agencies for the approval of specific 
        programs or projects, or for other details of the daily 
        administration of such activities, in accordance with 
        the Plan.
    (b) Certain Components of Plan.--With respect to AIDS 
activities of the agencies of the National Institutes of 
Health, the Director of the Office shall ensure that the Plan--
            (1) provides for basic research;
            (2) provides for applied research;
            (3) provides for research that is conducted by the 
        agencies;
            (4) provides for research that is supported by the 
        agencies;
            (5) provides for proposals developed pursuant to 
        solicitations by the agencies and for proposals 
        developed independently of such solicitations; and
            (6) provides for behavioral research and social 
        sciences research.
    (c) Budget Estimates.--
            (1) Full-funding budget.--
                    (A) With respect to a fiscal year, the 
                Director of the Office shall prepare and submit 
                directly to the President, for review and 
                transmittal to the Congress, a budget estimate 
                for carrying out the Plan for the fiscal year, 
                after reasonable opportunity for comment (but 
                without change) by the Secretary, the Director 
                of the National Institutes of Health, and the 
                advisory council established under section 
                2352. The budget estimate shall include an 
                estimate of the number and type of personnel 
                needs for the Office.
                    (B) The budget estimate submitted under 
                subparagraph (A) shall estimate the amounts 
                necessary for the agencies of the National 
                Institutes of Health to carry out all AIDS 
                activities determined by the Director of the 
                Office to be appropriate, without regard to the 
                probability that such amounts will be 
                appropriated.
            (2) Alternative budgets.--
                    (A) With respect to a fiscal year, the 
                Director of the Office shall prepare and submit 
                to the Secretary and the Director of the 
                National Institutes of Health the budget 
                estimates described in subparagraph (B) for 
                carrying out the Plan for the fiscal year. The 
                Secretary and such Director shall consider each 
                of such estimates in making recommendations to 
                the President regarding a budget for the Plan 
                for such year.
                    (B) With respect to the fiscal year 
                involved, the budget estimates referred to in 
                subparagraph (A) for the Plan are as follows:
                            (i) The budget estimate submitted 
                        under paragraph (1).
                            (ii) A budget estimate developed on 
                        the assumption that the amounts 
                        appropriated will be sufficient only 
                        for--
                                    (I) continuing the conduct 
                                by the agencies of the National 
                                Institutes of Health of 
                                existing AIDS activities (if 
                                approved for continuation), and 
                                continuing the support of such 
                                activities by the agencies in 
                                the case of projects or 
                                programs for which the agencies 
                                have made a commitment of 
                                continued support; and
                                    (II) carrying out, of 
                                activities that are in addition 
                                to activities specified in 
                                subclause (I), only such 
                                activities for which the 
                                Director determines there is 
                                the most substantial need.
                            (iii) Such other budget estimates 
                        as the Director of the Office 
                        determines to be appropriate.
    (d) Funding.--
            (1) Authorization of appropriations.--For the 
        purpose of carrying out AIDS activities under the Plan, 
        there are authorized to be appropriated such sums as 
        may be necessary for each of the fiscal years 1994 
        through 1996.
            (2) Receipt of funds.--For the first fiscal year 
        beginning after the date on which the Plan first 
        established under section 2353(a)(1) has been in effect 
        for 12 months, and for each subsequent fiscal year, the 
        Director of the Office shall receive directly from the 
        President and the Director of the Office of Management 
        and Budget all funds available for AIDS activities of 
        the National Institutes of Health.
            (3) Allocations for agencies.--
                    (A) Each fiscal year the Director of the 
                Office shall, from the amounts received under 
                paragraph (2) for the fiscal year, allocate to 
                the agencies of the National Institutes of 
                Health (in accordance with the Plan) all 
                amounts available for such year for carrying 
                out the AIDS activities specified in subsection 
                (c)(2)(B)(ii)(I) for such year. Such allocation 
                shall, to the extent practicable, be made not 
                later than 15 days after the date on which the 
                Director receives amounts under paragraph (2).
                    (B) Each fiscal year the Director of the 
                Office shall, from the amounts received under 
                paragraph (2) for the fiscal year, allocate to 
                the agencies of the National Institutes of 
                Health (in accordance with the Plan) all 
                amounts available for such year for carrying 
                out AIDS activities that are not referred to in 
                subparagraph (A). Such allocation shall, to the 
                extent practicable, be made not later than 30 
                days after the date on which the Director 
                receives amounts under paragraph (2).

SEC. 2354. [300CC-41] ADDITIONAL AUTHORITIES.

    (a) In General.--In carrying out AIDS research, the 
Director of the Office--
            (1) shall develop and expand clinical trials of 
        treatments and therapies for infection with the 
        etiologic agent for acquired immune deficiency 
        syndrome, including such clinical trials for women, 
        infants, children, hemophiliacs, and minorities;
            (2) may establish or support the large-scale 
        development and preclinical screening, production, or 
        distribution of specialized biological materials and 
        other therapeutic substances for AIDS research and set 
        standards of safety and care for persons using such 
        materials;
            (3) may support--
                    (A) AIDS research conducted outside the 
                United States by qualified foreign 
                professionals if such research can reasonably 
                be expected to benefit the people of the United 
                States;
                    (B) collaborative research involving 
                American and foreign participants; and
                    (C) the training of American scientists 
                abroad and foreign scientists in the United 
                States;
            (4) may encourage and coordinate AIDS research 
        conducted by any industrial concern that evidences a 
        particular capability for the conduct of such research;
            (5)(A) may acquire, improve, repair, operate, and 
        maintain laboratories, other research facilities, 
        equipment, and such other real or personal property as 
        the Director of the Office determines necessary;
            (B) may make grants for the construction or 
        renovation of facilities; and
            (C) may acquire, without regard to the Act of March 
        3, 1877 (40 U.S.C. 34) by lease or otherwise through 
        the Administrator of General Services, buildings or 
        parts of buildings in the District of Columbia or 
        communities located adjacent to the District of 
        Columbia for the use of the National Institutes of 
        Health for a period not to exceed ten years; and
            (6) subject to section 405(b)(2) and without regard 
        to section 3324 of title 31, United States Code, and 
        section 3709 of the Revised Statutes (41 U.S.C. 5), may 
        enter into such contracts and cooperative agreements 
        with any public agency, or with any person, firm, 
        association, corporation, or educational institution, 
        as may be necessary to expedite and coordinate research 
        relating to acquired immune deficiency syndrome.
    (b) Projects for Cooperation Among Public and Private 
Health Entities.--In carrying out subsection (a), the Director 
of the Office shall establish projects to promote cooperation 
among Federal agencies, State, local, and regional public 
health agencies, and private entities, in research concerning 
the diagnosis, prevention, and treatment of acquired immune 
deficiency syndrome.

                Subpart II--Emergency Discretionary Fund

SEC. 2356. [300CC-43] EMERGENCY DISCRETIONARY FUND.

    (a) In General.--
            (1) Establishment.--There is established a fund 
        consisting of such amounts as may be appropriated under 
        subsection (g). Subject to the provisions of this 
        section, the Director of the Office, after consultation 
        with the advisory council established under section 
        2352, may expend amounts in the Fund for the purpose of 
        conducting and supporting such AIDS activities, 
        including projects of AIDS research, as may be 
        authorized in this Act for the National Institutes of 
        Health.
            (2) Preconditions to use of fund.--Amounts in the 
        Fund may be expended only if--
                    (A) the Director identifies the particular 
                set of AIDS activities for which such amounts 
                are to be expended;
                    (B) the set of activities so identified 
                constitutes either a new project or additional 
                AIDS activities for an existing project;
                    (C) the Director of the Office has made a 
                determination that there is a significant need 
                for such set of activities; and
                    (D) as of June 30 of the fiscal year 
                preceding the fiscal year in which the 
                determination is made, such need was not 
                provided for in any appropriations Act passed 
                by the House of Representatives to make 
                appropriations for the Departments of Labor, 
                Health and Human Services (including the 
                National Institutes of Health), Education, and 
                related agencies for the fiscal year in which 
                the determination is made.
            (3) Two-year use of fund for project involved.--In 
        the case of an identified set of AIDS activities, 
        obligations of amounts in the Fund may not be made for 
        such set of activities after the expiration of the 2-
        year period beginning on the date on which the initial 
        obligation of such amounts is made for such set.
    (b) Peer Review.--With respect to an identified set of AIDS 
activities carried out with amounts in the Fund, this section 
may not be construed as waiving applicable requirements for 
peer review.
    (c) Limitations on Use of Fund.--
            (1) Construction of facilities.--Amounts in the 
        Fund may not be used for the construction, renovation, 
        or relocation of facilities, or for the acquisition of 
        land.
            (2) Congressional disapproval of projects.--
                    (A) Amounts in the Fund may not be expended 
                for the fiscal year involved for an identified 
                set of AIDS activities, or a category of AIDS 
                activities, for which--
                            (i)(I) amounts were made available 
                        in an appropriations Act for the 
                        preceding fiscal year; and
                            (II) amounts are not made available 
                        in any appropriations Act for the 
                        fiscal year involved; or
                            (ii) amounts are by law prohibited 
                        from being expended.
                    (B) A determination under subparagraph 
                (A)(i) of whether amounts have been made 
                available in appropriations Acts for a fiscal 
                year shall be made without regard to whether 
                such Acts make available amounts for the Fund.
            (3) Investment of fund amounts.--Amounts in the 
        Fund may not be invested.
    (d) Applicability of Limitation Regarding Number of 
Employees.--The purposes for which amounts in the Fund may be 
expended include the employment of individuals necessary to 
carry out identified sets of AIDS activities approved under 
subsection (a). Any individual employed under the preceding 
sentence may not be included in any determination of the number 
of full-time equivalent employees for the Department of Health 
and Human Services for the purpose of any limitation on the 
number of such employees established by law prior to, on, or 
after the date of the enactment of the National Institutes of 
Health Revitalization Act of 1993. \1\
    (e) Definitions.--For purposes of this section:
            (1) The term ``Fund'' means the fund established in 
        subsection (a).
            (2) The term ``identified set of AIDS activities'' 
        means a particular set of AIDS activities identified 
        under subsection (a)(2)(A).
    (f) Funding.--
            (1) Authorization of appropriations.--For the 
        purpose of providing amounts for the Fund, there is 
        authorized to be appropriated $100,000,000 for each of 
        the fiscal years 1994 through 1996.
            (2) Availability.--Amounts appropriated for the 
        Fund are available until expended.

                    Subpart III--General Provisions

SEC. 2359. [300CC-45] GENERAL PROVISIONS REGARDING THE OFFICE.

    (a) Administrative Support for Office.--The Secretary, 
acting through the Director of the National Institutes of 
Health, shall provide administrative support and support 
services to the Director of the Office and shall ensure that 
such support takes maximum advantage of existing administrative 
structures at the agencies of the National Institutes of 
Health.
    (b) Evaluation.--Not later than 5 years after the date of 
the enactment of National Institutes of Health Revitalization 
Act of 1993, \1\ the Secretary shall conduct an evaluation to--
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    \1\ Enacted June 10, 1993.
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            (1) determine the effect of this section on the 
        planning and coordination of the AIDS research programs 
        at the institutes, centers and divisions of the 
        National Institutes of Health;
            (2) evaluate the extent to which this part has 
        eliminated the duplication of administrative resources 
        among such Institutes, centers and divisions; and
            (3) provide recommendations concerning future 
        alterations with respect to this part.
    (c) Definitions.--For purposes of this part:
            (1) The term ``AIDS activities'' means AIDS 
        research and other activities that relate to acquired 
        immune deficiency syndrome.
            (2) The term ``AIDS research'' means research with 
        respect to acquired immune deficiency syndrome.
            (3) The term ``Office'' means the Office of AIDS 
        Research.
            (4) The term ``Plan'' means the plan required in 
        section 2353(a)(1).

                       Part E--General Provisions

SEC. 2361. [300CC-51] DEFINITION.

    For purposes of this title:
            (1) The term ``infection'', with respect to the 
        etiologic agent for acquired immune deficiency 
        syndrome, includes opportunistic cancers and infectious 
        diseases and any other conditions arising from 
        infection with such etiologic agent.
            (2) The term ``treatment'', with respect to the 
        etiologic agent for acquired immune deficiency 
        syndrome, includes primary and secondary 
        prophylaxis.ATTORNEY: PMG/FD (June 22, 
        1999) deg.
 H1  deg.TITLE XXIV--HEALTH SERVICES WITH RESPECT TO ACQUIRED 
                     IMMUNE DEFICIENCY SYNDROME \1\

     H2  deg.Part A--Formula Grants to States for Home and 
                    Community-Based Health Services

 H4  deg.SEC. 2401. [300DD] ESTABLISHMENT OF PROGRAM.

    (a) Allotments for States.--For the purpose described in 
subsection (b), the Secretary shall for each of the fiscal 
years 1989 and 1990 make an allotment for each State in an 
amount determined in accordance with section 2408. The 
Secretary shall make payments each such fiscal year to each 
State from the allotment for the State if the Secretary 
approves for the fiscal year involved an application submitted 
by the State pursuant to section 2407.
---------------------------------------------------------------------------
    \1\ See footnote at beginning of title XXIII.
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    (b) Purpose of Grants.--The Secretary may not make payments 
under subsection (a) for a fiscal year unless the State 
involved agrees to expend the payments only for the purpose of 
providing services in accordance with section 2402.
    (c) Eligible Individual Defined.--For purposes of this 
part:
            (1) The term ``eligible individual'' means an 
        individual infected with the etiologic agent for 
        acquired immune deficiency syndrome who either is 
        medically dependent or chronically dependent.
            (2) The term ``medically dependent'' means, with 
        respect to an individual, that the individual has been 
        certified by a physician as--
                    (A) requiring the routine use of 
                appropriate medical services (which may include 
                home intravenous drug therapy) to prevent or 
                compensate for the individual's serious 
                deterioration, arising from infection with the 
                etiologic agent for acquired immune deficiency 
                syndrome, of physical health or cognitive 
                function, and
                    (B) being able to avoid long-term or 
                repeated care as an inpatient or resident in a 
                hospital, nursing facility, or other 
                institution if home and community-based health 
                services are provided to the individual.
            (3) The term ``chronically dependent'' means, with 
        respect to an individual, that the individual has been 
        certified by a physician as--
                    (A) being unable to perform, because of 
                physical or cognitive impairment (without 
                substantial assistance from another individual) 
                arising from infection with the etiologic agent 
                for acquired immune deficiency syndrome, at 
                least 2 of the following activities of daily 
                living: bathing, dressing, toileting, 
                transferring, and eating, or
                    (B) having a similar level of disability 
                due to cognitive impairment (as defined by the 
                Secretary).
    (d) Home and Community-Based Health Services Defined.--For 
purposes of this part, the term ``home and community-based 
health services''--
            (1) means, with respect to an eligible individual, 
        skilled health services furnished to the individual in 
        the individual's home pursuant to a written plan of 
        care established by a health care professional for the 
        provision of such services and items and services 
        described in paragraph (2);
            (2) includes--
                    (A) durable medical equipment,
                    (B) homemaker/home health aide services and 
                personal care services furnished in the 
                individual's home,
                    (C) day treatment or other partial 
                hospitalization services,
                    (D) home intravenous drug therapy 
                (including prescription drugs administered 
                intravenously as part of such therapy), and
                    (E) routine diagnostic tests administered 
                in the individual's home,
        furnished pursuant to such plan of care; but
            (3) does not include, except as specifically 
        provided in paragraph (2)--
                    (A) diagnostic tests,
                    (B) inpatient hospital services,
                    (C) nursing facility services, and
                    (D) prescription drugs.

SEC. 2402. [300DD-1] PROVISIONS WITH RESPECT TO CARRYING OUT PURPOSE OF 
                    GRANTS.

    (a) Required Uses of Funds.--The Secretary may not make 
payments under section 2401(a) unless the State involved agrees 
that the State will--
            (1) provide for home and community-based health 
        services for eligible individuals pursuant to written 
        plans of care established by health care professionals 
        for providing such services to such individuals;
            (2) provide for the identification, location, and 
        provision of outreach to eligible individuals;
            (3) provide for coordinating the provision of 
        services under this part with the provision of similar 
        or related services by public and private entities; and
            (4) give priority to the provision of outreach and 
        home and community-based services to eligible 
        individuals with low incomes.
    (b) Authority for Grants and Contracts.--A State may make 
payment for services under subsection (a) through grants to 
public and nonprofit private entities and through contracts 
with public and private entities. In providing such financial 
assistance, a State shall give priority to public and nonprofit 
private entities that have demonstrated experience in 
delivering home and community-based health services to 
individuals infected with the etiologic agent for acquired 
immune deficiency syndrome.

SEC. 2403. [300DD-2] REQUIREMENT OF SUBMISSION OF DESCRIPTION OF 
                    INTENDED USES OF GRANT.

    The Secretary may not make payments under section 2401(a) 
to a State for a fiscal year unless--
            (1) the State submits to the Secretary a 
        description of the purposes for which the State intends 
        to expend such payments for the fiscal year;
            (2) such description provides information relating 
        to the services and activities to be provided, 
        including a description of the manner in which such 
        services and activities will be coordinated with any 
        similar services and activities of public and private 
        entities; and
            (3) such description includes information relating 
        to (A) the process for determining which eligible 
        individuals are medically dependent or chronically 
        dependent and (B) the process for establishing written 
        plans of care for the provision of home and community-
        based health services under this part.

 H4  deg.SEC. 2404. [300DD-3] RESTRICTIONS ON USE OF GRANT.

    (a) In General.--The Secretary may not make payments under 
section 2401(a) for a fiscal year to a State unless the State 
agrees that the payments will not be expended--
            (1) to provide for items or services described in 
        section 2401(d)(3);
            (2) to make cash payments to intended recipients of 
        services;
            (3) to purchase or improve real property (other 
        than minor remodeling of existing improvements to real 
        property) or to purchase major medical equipment; or
            (4) to satisfy any requirement for the expenditure 
        of non-Federal funds as a condition for the receipt of 
        Federal funds.
    (b) Limitation on Administrative Expenses.--The Secretary 
may not make payments under section 2401(a) for a fiscal year 
unless the State involved agrees that the State will not expend 
more than 5 percent of the payments made to the State under 
such section for administrative expenses with respect to 
carrying out the purpose of this part.
    (c) Limitation on Total Payments.--
            (1) Before March 1, 1989, for fiscal year 1989 and 
        before September 1, 1989, for fiscal year 1990, the 
        Secretary shall determine and publish the national 
        average monthly payments, for extended care services 
        under part A of title XVIII of the Social Security Act, 
        for each resident of a skilled nursing facility the 
        Secretary estimates will be paid in the fiscal year.
            (2) The Secretary may not make payments under 
        section 2401(a) for a fiscal year to a State to the 
        extent that the average monthly payments for eligible 
        individuals provided home and community-based health 
        services under this part in the State exceeds 65 
        percent of the national average monthly payments 
        determined and published for the fiscal year under 
        paragraph (1).

 H4  deg.SEC. 2405. [300DD-4] REQUIREMENT OF REPORTS AND 
                    AUDITS BY STATES.

    (a) Reports.--
            (1) The Secretary may not make payments under 
        section 2401(a) for a fiscal year unless the State 
        involved agrees to prepare and submit to the Secretary, 
        by not later than January 1 following the fiscal year, 
        an annual report in such form and containing such 
        information as the Secretary determines (after 
        consultation with the States and the Comptroller 
        General of the United States) to be necessary for--
                    (A) securing a record and a description of 
                the purposes for which payments received by the 
                State pursuant to section 2401(a) were expended 
                and of the recipients of such payments;
                    (B) determining whether the payments were 
                expended in accordance with the purpose of this 
                part; and
                    (C) determining the percentage of payments 
                received pursuant to section 2401(a) that were 
                expended by the State for administrative 
                expenses during the fiscal year involved.
            (2) Each report by a State under paragraph (1) for 
        a fiscal year also shall include--
                    (A) information on the number and type of 
                eligible individuals provided home and 
                community-based health services by the State 
                under this part for the fiscal year;
                    (B) information on the types of home and 
                community-based health services so provided;
                    (C) information on the average monthly 
                costs of such services and a comparison of such 
                costs with costs of providing services in 
                hospitals, nursing facilities, and similar 
                institutions; and
                    (D) such other information as the Secretary 
                may require to provide for an evaluation of the 
                program under this part and its cost-
                effectiveness.
    (b) Audits.--
            (1) The Secretary may not make payments under 
        section 2401(a) for a fiscal year unless the State 
        involved agrees to establish such fiscal control and 
        fund accounting procedures as may be necessary to 
        ensure the proper disbursal of, and accounting for, 
        amounts received by the State under such section.
            (2) The Secretary may not make payments under 
        section 2401(a) for a fiscal year unless the State 
        involved agrees that--
                    (A) the State will provide for--
                            (i) a financial and compliance 
                        audit of such payments; or
                            (ii) a single financial and 
                        compliance audit of each entity 
                        administering such payments;
                    (B) the audit will be performed biennially 
                and will cover expenditures in each fiscal 
                year; and
                    (C) the audit will be conducted in 
                accordance with standards established by the 
                Comptroller General of the United States for 
                the audit of governmental organizations, 
                programs, activities, and functions.
            (3) The Secretary may not make payments under 
        section 2401(a) for a fiscal year unless the State 
        involved agrees that, not later than 30 days after the 
        completion of an audit under paragraph (2), the State 
        will provide a copy of the audit report to the State 
        legislature.
            (4) For purposes of paragraph (2), the term 
        ``financial and compliance audit'' means an audit to 
        determine whether the financial statements of an 
        audited entity present fairly the financial position, 
        and the results of financial operations, of the entity 
        in accordance with generally accepted accounting 
        principles, and whether the entity has complied with 
        laws and regulations that may have a material effect 
        upon the financial statements.
    (c) Availability to Public.--The Secretary may not make 
payments under section 2401(a) unless the State involved agrees 
to make copies of the reports and audits described in this 
section available for public inspection.
    (d) Evaluations by Comptroller General.--The Comptroller 
General of the United States shall, from time to time, evaluate 
the expenditures by the States of payments under section 
2401(a) in order to assure that expenditures are consistent 
with the provisions of this part.

 H4  deg.SEC. 2406. [300DD-5] ADDITIONAL REQUIRED AGREEMENTS.

    (a) \1\ In General.--The Secretary may not make payments 
under section 2401(a) for a fiscal year unless the State 
involved agrees that--
---------------------------------------------------------------------------
    \1\ So in law. This section does not contain a subsection (b).
---------------------------------------------------------------------------
            (1) the legislature of the State will conduct 
        public hearings on the proposed use and distribution of 
        the payments to be received from the allotments for 
        each such fiscal year;
            (2)(A) the State will, to the maximum extent 
        practicable, ensure that services provided to an 
        individual pursuant to the program involved will be 
        provided without regard to the ability of the 
        individual to pay for such services and without regard 
        to the current or past health condition of the 
        individual;
            (B) if any charges are imposed for the provision of 
        home and community-based health services for which 
        assistance is provided under this part, such charges 
        (i) will be pursuant to a public schedule of charges, 
        (ii) will not be imposed on any eligible individual 
        with an income that does not exceed 100 percent of the 
        official poverty line, and (iii) for an eligible 
        individual with an income that exceeds 100 percent of 
        the official poverty line, will be adjusted to reflect 
        the income of the individual;
            (3) the State will provide for periodic independent 
        peer review to assess the quality and appropriateness 
        of home and community-based health services provided by 
        entities that receive funds from the State pursuant to 
        section 2401(a);
            (4) the State will permit and cooperate with 
        Federal investigations undertaken under section 
        2409(e);
            (5) the State will maintain State expenditures for 
        home and community-based health services for 
        individuals infected with the etiologic agent for 
        acquired immune deficiency syndrome at a level equal to 
        not less than the average level of such expenditures 
        maintained by the State for the 2-year period preceding 
        the fiscal year for which the State is applying to 
        receive payments; and
            (6) the State will not make payments from 
        allotments made under section 2401(a) for any item or 
        service to the extent that payment has been made, or 
        can reasonably be expected to be made, with respect to 
        that item or service (i) under any State compensation 
        program, under an insurance policy, under any Federal 
        or State health benefits program, or (ii) by an entity 
        that provides health services on a prepaid basis.

SEC. 2407. [300DD-6] REQUIREMENT OF SUBMISSION OF APPLICATION 
                    CONTAINING CERTAIN AGREEMENTS AND ASSURANCES.

    The Secretary may not make payments under section 2401(a) 
to a State for a fiscal year unless--
            (1) the State submits to the Secretary an 
        application for the payments containing agreements in 
        accordance with sections 2401 through 2406;
            (2) the agreements are made through certification 
        from the chief executive officer of the State;
            (3) with respect to such agreements, the 
        application provides assurances of compliance 
        satisfactory to the Secretary;
            (4) the application contains the description of 
        intended expenditures required in section 2403; and
            (5) the application otherwise is in such form, is 
        made in such manner, and contains such agreements, 
        assurances, and information as the Secretary determines 
        to be necessary to carry out this part.

 H4  deg.SEC. 2408. [300DD-7] DETERMINATION OF AMOUNT OF 
                    ALLOTMENTS FOR STATES.

    (a) Minimum Allotment.--Subject to the extent of amounts 
made available in appropriations Acts, the amount of an 
allotment under section 2401(a) for--
            (1) each of the several States, the District of 
        Columbia, and the Commonwealth of Puerto Rico, for a 
        fiscal year shall be the greater of--
                    (A) $100,000, and
                    (B) an amount determined under subsection 
                (b); and
            (2) each territory of the United States (as defined 
        in section 2413(5)) shall be $25,000.
    (b) Determination Under Formula.--
            (1) The amount referred to in subsection (a)(1)(B) 
        for a State is the product of--
                    (A) an amount equal to the amount 
                appropriated pursuant to section 2414(a) for 
                the fiscal year involved; and
                    (B) the ratio of the distribution factor 
                for the State to the sum of the distribution 
                factors for all the States.
            (2) In paragraph (1)(B), the term ``distribution 
        factor'' means, for a State, the product of--
                    (A) the number in the State of additional 
                cases of acquired immune deficiency syndrome, 
                as indicated by the number of such cases 
                reported to and confirmed by the Secretary for 
                the most recent fiscal year for which such data 
                are available, and
                    (B) the ratio (based on the most recent 
                available data) of (i) the average per capita 
                income of individuals in the United States to 
                (ii) the average per capita income of 
                individuals in the State;
        except that the distribution factors for all the States 
        and territories shall be proportionally reduced to the 
        extent necessary to assure that the total of the 
        allotments under subsection (a) for all the States and 
        territories for each fiscal year does not exceed the 
        amount appropriated pursuant to section 2414(a) for the 
        fiscal year.
    (c) Indian Tribes.--
            (1) Upon the request of the governing body of an 
        Indian tribe or tribal organization within a State to 
        the Secretary, the Secretary shall--
                    (A) reserve from the amount that otherwise 
                would be allotted for the fiscal year to the 
                State under subsection (a) an amount determined 
                in accordance with paragraph (2); and
                    (B) grant the amount reserved under 
                subparagraph (A) to the Indian tribe or tribal 
                organization serving eligible individuals who 
                are members of the Indian tribe or tribal 
                organization.
            (2) The amount reserved under paragraph (1)(A) 
        shall be an amount equal to the product of--
                    (A) the amount that otherwise would be 
                allotted to the State under subsection (a) for 
                the fiscal year; and
                    (B) the Secretary's estimate of the 
                proportion of the number of additional cases 
                described in subsection (b)(2)(A) that are 
                attributable to members of the Indian tribe or 
                tribal organization.
            (3) The Secretary may not make a grant under 
        paragraph (1)(B) to an Indian tribe or tribal 
        organization unless the Indian tribe or tribal 
        organization submits to the Secretary an application 
        meeting the requirements of such an application under 
        section 2407.
    (d) Disposition of Certain Funds Appropriated for 
Allotments.--
            (1) Amounts described in paragraph (2) shall, in 
        accordance with paragraph (3), be allotted by the 
        Secretary to States receiving payments under section 
        2401(a) for the fiscal year (other than any State 
        referred to in paragraph (2)(B)).
            (2) The amounts referred to in paragraph (1) are 
        any amounts that are not paid to States or territories 
        under section 2401(a) as a result of--
                    (A) the failure of any State or territory 
                to submit an application under section 2407 
                within a reasonable time period established by 
                the Secretary; or
                    (B) any State or territory informing the 
                Secretary that the State or territory does not 
                intend to expend the full amount of the 
                allotment made to the State or territory.
            (3) The amount of an allotment under paragraph (1) 
        for a State for a fiscal year shall be an amount equal 
        to the product of--
                    (A) an amount equal to the amount described 
                in paragraph (2) for the fiscal year involved; 
                and
                    (B) the ratio determined under subsection 
                (b)(1)(B) for the State.

 H4  deg.SEC. 2409. [300DD-8] FAILURE TO COMPLY WITH 
                    AGREEMENTS.

    (a) Repayment of Payments.--
            (1) The Secretary may, subject to subsection (c), 
        require a State to repay any payments received by the 
        State under section 2401(a) that the Secretary 
        determines were not expended by the State in accordance 
        with the agreements required to be contained in the 
        application submitted by the State pursuant to section 
        2407.
            (2) If a State fails to make a repayment required 
        in paragraph (1), the Secretary may offset the amount 
        of the repayment against the amount of any payment due 
        to be paid to the State under section 2401(a).
    (b) Withholding of Payments.--
            (1) The Secretary may, subject to subsection (c), 
        withhold payments due under section 2401(a) if the 
        Secretary determines that the State involved is not 
        expending amounts received under such section in 
        accordance with the agreements required to be contained 
        in the application submitted by the State pursuant to 
        section 2407.
            (2) The Secretary shall cease withholding payments 
        from a State under paragraph (1) if the Secretary 
        determines that there are reasonable assurances that 
        the State will expend amounts received under section 
        2401(a) in accordance with the agreements referred to 
        in such paragraph.
    (c) Opportunity for Hearing.--Before requiring repayment of 
payments under subsection (a)(1), or withholding payments under 
subsection (b)(1), the Secretary shall provide to the State an 
opportunity for a hearing conducted within the State.
    (d) Technical Violations.--The Secretary may not require 
repayment under subsection (a)(1), or withhold payments under 
subsection (b)(1), for a technical violation, as determined by 
the Secretary, of any agreement required to be contained in the 
application submitted by the State pursuant to section 2407.
    (e) Investigations.--
            (1) The Secretary shall conduct in several States 
        in each fiscal year investigations of the expenditure 
        of payments received by the States under section 
        2401(a) in order to evaluate compliance with the 
        agreements required to be contained in the applications 
        submitted to the Secretary pursuant to section 2407.
            (2) Each State, and each entity receiving funds 
        from payments made to a State under section 2401(a), 
        shall make appropriate books, documents, papers, and 
        records available to the Secretary and the Comptroller 
        General of the United States, or any of their duly 
        authorized representatives, for examination, copying, 
        or mechanical reproduction on or off the premises of 
        the appropriate entity upon a reasonable request 
        therefor.
            (3)(A) In conducting any investigation in a State, 
        the Secretary and the Comptroller General of the United 
        States may not make a request for any information not 
        readily available to the State, or to an entity 
        receiving funds from payments made to the State under 
        section 2401(a), or make an unreasonable request for 
        information to be compiled, collected, or transmitted 
        in any form not readily available.
            (B) Subparagraph (A) shall not apply to the 
        collection, compilation, or transmittal of data in the 
        course of a judicial proceeding.

 H4  deg.SEC. 2410. [300DD-9] PROHIBITION AGAINST CERTAIN 
                    FALSE STATEMENTS.

    (a) In General.--A person may not knowingly make or cause 
to be made any false statement or representation of a material 
fact in connection with the furnishing of items or services for 
which amounts may be paid by a State from payments received by 
the State under section 2401(a).
    (b) Criminal Penalty for Violation of Prohibition.--Any 
person who violates a prohibition established in subsection (a) 
may for each violation be fined in accordance with title 18, 
United States Code, or imprisoned for not more than 5 years, or 
both.

SEC. 2411. [300DD-10] TECHNICAL ASSISTANCE AND PROVISION BY SECRETARY 
                    OF SUPPLIES AND SERVICES IN LIEU OF GRANT FUNDS.

    (a) Technical Assistance.--Upon the request of a State 
receiving payments under section 2401(a), the Secretary may, 
without charge to the State, provide to the State (or to any 
public or private entity designated by the State) technical 
assistance with respect to the planning, development, and 
operation of any program or service carried out pursuant to 
this part. The Secretary may provide such technical assistance 
directly, through contract, or through grants.
    (b) Provision by Secretary of Supplies and Services in Lieu 
of Grant Funds.--
            (1) Upon the request of a State receiving payments 
        under section 2401(a), the Secretary may, subject to 
        paragraph (2), provide supplies, equipment, and 
        services for the purpose of aiding the State in 
        carrying out this part and, for such purpose, may 
        detail to the State any officer or employee of the 
        Department of Health and Human Services.
            (2) With respect to a request described in 
        paragraph (1), the Secretary shall reduce the amount of 
        payments under section 2401(a) to the State by an 
        amount equal to the costs of detailing personnel and 
        the fair market value of any supplies, equipment, or 
        services provided by the Secretary. The Secretary 
        shall, for the payment of expenses incurred in 
        complying with such request, expend the amounts 
        withheld.

 H4  deg.SEC. 2412. [300DD-11] REPORT BY SECRETARY.

    Not later than March 1, 1990, the Secretary shall report to 
the Congress on the activities of the States under this part. 
Such report shall include a recommendation as to whether or not 
the program under this part should be extended beyond fiscal 
year 1990 and may include any recommendations of the Secretary 
for appropriate administrative and legislative initiatives.

 H4  deg.SEC. 2413. [300DD-12] DEFINITIONS.

    For purposes of this part:
            (1) The terms ``Indian tribe'' and ``tribal 
        organization'' have the same meaning given such terms 
        in sections 4(b) and 4(c) of the Indian Self-
        Determination and Education Assistance Act.
            (2) The term ``infected with the etiologic agent 
        for acquired immune deficiency syndrome'' includes any 
        condition arising from infection with such etiologic 
        agent.
            (3)(A) An individual is considered to have low 
        income if the individual's income does not exceed 200 
        percent of the official poverty line.
            (B) The term ``official poverty line'' refers, with 
        respect to an individual, to the official poverty line 
        defined by the Office of Management and Budget, and 
        revised annually in accordance with section 673(2) of 
        the Omnibus Budget Reconciliation Act of 1981, 
        applicable to a family of the size involved.
            (4)(A) The term ``State'' means, except as provided 
        in subparagraph (B), each of the several States, the 
        District of Columbia, the Commonwealth of Puerto Rico, 
        and each territory of the United States.
            (B) For purposes of subsections (b) and (d) of 
        section 2408, the term ``State'' means each of the 
        several States, the District of Columbia, and the 
        Commonwealth of Puerto Rico.
            (5) The term ``territory of the United States'' 
        means each of the following: the Virgin Islands, Guam, 
        American Samoa, and the Commonwealth of the Northern 
        Mariana Islands.

 H4  deg.SEC. 2414. [300DD-13] FUNDING.

    (a) Authorization of Appropriations.--For the purpose of 
making allotments under section 2401(a), there are authorized 
to be appropriated $100,000,000 for each of the fiscal years 
1989 and 1990.
    (b) Availability to States.--Any amounts paid to a State or 
territory under section 2401(a) shall remain available to the 
State or territory until the expiration of the 1-year period 
beginning on the date on which the State or territory receives 
such amounts.

 H4  deg.SEC. 2415. [300DD-14] SUNSET.

    Effective with respect to appropriations made for any 
period after fiscal year 1990, this part is repealed.

                 H2  deg.Part B--Subacute Care

 H4  deg.SEC. 2421. [300DD-21] DEMONSTRATION PROJECTS.

    (a) As used in this section:
            (1) The term ``individuals infected with the 
        etiologic agent for acquired immune deficiency 
        syndrome'' means individuals who have a disease, or are 
        recovering from a disease, attributable to the 
        infection of such individuals with such etiologic 
        agent, and as a result of the effects of such disease, 
        are in need of subacute-care services.
            (2) The term ``subacute care'' means medical and 
        health care services that are required for individuals 
        recovering from acute care episodes that are less 
        intensive than the level of care provided in acute-care 
        hospitals, and includes skilled nursing care, hospice 
        care, and other types of health services provided in 
        other long-term-care facilities.
    (b) The Secretary shall conduct three demonstration 
projects to determine the effectiveness and cost of providing 
the subacute-care services described in subsection (b) to 
individuals infected with the etiologic agent for acquired 
immune deficiency syndrome, and the impact of such services on 
the health status of such individuals.
    (c)(1) The services provided under each demonstration 
project shall be designed to meet the specific needs of 
individuals infected with the etiologic agent for acquired 
immune deficiency syndrome, and shall include--
            (A) the care and treatment of such individuals by 
        providing--
                    (i) subacute care;
                    (ii) emergency medical care and specialized 
                diagnostic and therapeutic services as needed 
                and where appropriate, either directly or 
                through affiliation with a hospital that has 
                experience in treating individuals with 
                acquired immune deficiency syndrome; and
                    (iii) case management services to ensure, 
                through existing services and programs whenever 
                possible, appropriate discharge planning for 
                such individuals; and
            (B) technical assistance, to other facilities in 
        the region served by such facility, that is directed 
        toward education and training of physicians, nurses, 
        and other health-care professionals in the subacute 
        care and treatment of individuals infected with the 
        etiologic agent for acquired immune deficiency 
        syndrome.
    (2) Services provided under each demonstration project may 
also include--
            (A) hospice services;
            (B) outpatient care; and
            (C) outreach activities in the surrounding 
        community to hospitals and other health-care facilities 
        that serve individuals infected with the etiologic 
        agent for acquired immune deficiency syndrome.
    (d) The demonstration projects shall be conducted--
            (1) during a 4-year period beginning not later than 
        9 months after the date of enactment of this section; 
        \1\ and
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    \1\ Enacted on November 4, 1988.
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            (2) at sites that--
                    (A) are geographically diverse and located 
                in areas that are appropriate for the provision 
                of the required and authorized services; and
                    (B) have the highest incidence of cases of 
                acquired immune deficiency syndrome and the 
                greatest need for subacute-care services.
    (e) The Secretary shall evaluate the operations of the 
demonstration projects and shall submit to the Committee on 
Energy and Commerce of the House of Representatives and the 
Committee on Labor and Human Resources of the Senate--
            (1) not later than 18 months after the beginning of 
        the first project, a preliminary report that contains--
                    (A) a description of the sites at which the 
                projects are being conducted and of the 
                services being provided in each project; and
                    (B) a preliminary evaluation of the 
                experience of the projects in the first 12 
                months of operation; and
            (2) not later than 6 months after the completion of 
        the last project, a final report that contains--
                    (A) an assessment of the costs of subacute 
                care for individuals infected with the 
                etiologic agent for acquired immune deficiency 
                syndrome, including a breakdown of all other 
                sources of funding for the care provided to 
                cover subacute care; and
                    (B) recommendations for appropriate 
                legislative changes.
    (f) Each demonstration project shall provide for other 
research to be carried out at the site of such demonstration 
project including--
            (1) clinical research on acquired immune deficiency 
        syndrome, concentrating on research on the neurological 
        manifestations resulting from infection with the 
        etiologic agent for such syndrome; and
            (2) the study of the psychological and mental 
        health issues related to such syndrome.
    (g)(1) To carry out this section, there are authorized to 
be appropriated $10,000,000 for fiscal year 1989 and such sums 
as are necessary for each of the fiscal years 1990 through 
1992.
    (2) Amounts appropriated pursuant to paragraph (1) shall 
remain available until September 10, 1992.
    (h) The Secretary shall enter into an agreement with the 
Administrator of the Veterans' Administration to ensure that 
appropriate provision will be made for the furnishing, through 
demonstration projects, of services to eligible veterans, under 
contract with the Veterans' Administration pursuant to section 
620 of title 38, United States Code.

             H2  deg.Part C--Other Health Services

 H4  deg.SEC. 2431. [300DD-31] GRANTS FOR ANONYMOUS TESTING.

    The Secretary may make grants to the States for the purpose 
of providing opportunities for individuals--
            (1) to undergo counseling and testing with respect 
        to the etiologic agent for acquired immune deficiency 
        syndrome without being required to provide any 
        information relating to the identity of the 
        individuals; and
            (2) to undergo such counseling and testing through 
        the use of a pseudonym.

SEC. 2432. [300DD-32] REQUIREMENT OF PROVISION OF CERTAIN COUNSELING 
                    SERVICES.

    (a) Counseling Before Testing.--The Secretary may not make 
a grant under section 2431 to a State unless the State agrees 
that, before testing an individual pursuant to such section, 
the State will provide to the individual appropriate counseling 
with respect to acquired immune deficiency syndrome (based on 
the most recent scientific data relating to such syndrome), 
including--
            (1) measures for the prevention of exposure to, and 
        the transmission of, the etiologic agent for such 
        syndrome;
            (2) the accuracy and reliability of the results of 
        such testing;
            (3) the significance of the results of such 
        testing, including the potential for developing 
        acquired immune deficiency syndrome; and
            (4) encouraging individuals, as appropriate, to 
        undergo testing for such etiologic agent and providing 
        information on the benefits of such testing.
    (b) Counseling of Individuals With Negative Test Results.--
The Secretary may not make a grant under section 2431 to a 
State unless the State agrees that, if the results of testing 
conducted pursuant to such section indicate that an individual 
is not infected with the etiologic agent for acquired immune 
deficiency syndrome, the State will review for the individual 
the information provided pursuant to subsection (a) with 
respect to such syndrome, including--
            (1) the information described in paragraphs (1) 
        through (3) of such subsection; and
            (2) the appropriateness of further counseling, 
        testing, and education of the individual with respect 
        to acquired immune deficiency syndrome.
    (c) Counseling of Individuals With Positive Test Results.--
The Secretary may not make a grant under section 2431 to a 
State unless the State agrees that, if the results of testing 
conducted pursuant to such section indicate that an individual 
is infected with the etiologic agent for acquired immune 
deficiency syndrome, the State will provide to the individual 
appropriate counseling with respect to such syndrome, 
including--
            (1) reviewing the information described in 
        paragraphs (1) through (3) of subsection (a);
            (2) reviewing the appropriateness of further 
        counseling, testing, and education of the individual 
        with respect to acquired immune deficiency syndrome;
            (3) the importance of not exposing others to the 
        etiologic agent for acquired immune deficiency 
        syndrome;
            (4) the availability in the geographic area of any 
        appropriate services with respect to health care, 
        including mental health care and social and support 
        services;
            (5) the benefits of locating and counseling any 
        individual by whom the infected individual may have 
        been exposed to the etiologic agent for acquired immune 
        deficiency syndrome and any individual whom the 
        infected individual may have exposed to such etiologic 
        agent; and
            (6) the availability, if any, of the services of 
        public health authorities with respect to locating and 
        counseling any individual described in paragraph (5).
    (d) Rule of Construction With Respect to Counseling Without 
Testing.--Agreements entered into pursuant to subsections (a) 
through (c) may not be construed to prohibit any grantee under 
section 2431 from expending the grant for the purpose of 
providing counseling services described in such subsections to 
an individual who will not undergo testing described in such 
section as a result of the grantee or the individual 
determining that such testing of the individual is not 
appropriate.
    (e) Use of Funds.--
            (1) The purpose of this subpart \1\ is to provide 
        for counseling and testing services to prevent and 
        reduce exposure to, and transmission of, the etiologic 
        agent for acquired immune deficiency syndrome.
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    \1\ Probably should be ``part''. See section 118(b)(1)(B) of Public 
Law 102-321 (106 Stat. 348).
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            (2) All individuals receiving counseling pursuant 
        to this subpart \1\ are to be counseled about the 
        harmful effects of promiscuous sexual activity and 
        intravenous substance abuse, and the benefits of 
        abstaining from such activities.
            (3) None of the fund appropriated to carry out this 
        subpart \1\ may be used to provide counseling that is 
        designed to promote or encourage, directly, homosexual 
        or heterosexual sexual activity or intravenous drug 
        abuse.
            (4) Paragraph (3) may not be construed to prohibit 
        a counselor who has already performed the counseling of 
        an individual required by paragraph (2), to provide 
        accurate information about means to reduce an 
        individual's risk of exposure to, or the transmission 
        of, the etiologic agent for acquired immune deficiency 
        syndrome, provided that any informational materials 
        used are not obscene. * deg.

 H4  deg.SEC. 2433. [300DD-33] FUNDING.

    For the purpose of grants under section 2431, there are 
authorized to be appropriated $100,000,000 for each of the 
fiscal years 1989 and 1990.ATTORNEY: PMG/FD (June 22, 
1999) deg.
    TITLE XXV--PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME \1\

 H4  deg.SEC. 2500. [300EE] USE OF FUNDS.

    (a) In General.--The purpose of this title is to provide 
for the establishment of education and information programs to 
prevent and reduce exposure to, and the transmission of, the 
etiologic agent for acquired immune deficiency syndrome.
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    \1\ See footnote at beginning of title XXIII.
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    (b) Contents of Programs.--All programs of education and 
information receiving funds under this title shall include 
information about the harmful effects of promiscuous sexual 
activity and intravenous substance abuse, and the benefits of 
abstaining from such activities.
    (c) Limitation.--None of the funds appropriated to carry 
out this title may be used to provide education or information 
designed to promote or encourage, directly, homosexual or 
heterosexual sexual activity or intravenous substance abuse.
    (d) Construction.--Subsection (c) may not be construed to 
restrict the ability of an education program that includes the 
information required in subsection (b) to provide accurate 
information about various means to reduce an individual's risk 
of exposure to, or the transmission of, the etiologic agent for 
acquired immune deficiency syndrome, provided that any 
informational materials used are not obscene.

                    Part A--Formula Grants to States

 H4  deg.SEC. 2501. [300EE-11] ESTABLISHMENT OF PROGRAM.

    (a) Allotments for States.--For the purpose described in 
subsection (b), the Secretary shall for each of the fiscal 
years 1989 through 1991 make an allotment for each State in an 
amount determined in accordance with section 2507. The 
Secretary shall make payments each such fiscal year to each 
State from the allotment for the State if the Secretary 
approves for the fiscal year involved an application submitted 
by the State pursuant to section 2503.
    (b) Purpose of Grants.--The Secretary may not make payments 
under subsection (a) for a fiscal year unless the State 
involved agrees to expend the payments only for the purpose of 
carrying out, in accordance with section 2502, public 
information activities with respect to acquired immune 
deficiency syndrome.

 H4  deg.SEC. 2502. [300EE-12] PROVISIONS WITH RESPECT TO 
                    CARRYING OUT PURPOSE OF GRANTS.

    A State may expend payments received under section 
2501(a)--
            (1) to develop, establish, and conduct public 
        information activities relating to the prevention and 
        diagnosis of acquired immune deficiency syndrome for 
        those populations or communities in the State in which 
        there are a significant number of individuals at risk 
        of infection with the etiologic agent for such 
        syndrome;
            (2) to develop, establish, and conduct such public 
        information activities for the general public relating 
        to the prevention and diagnosis of such syndrome;
            (3) to develop, establish, and conduct activities 
        to reduce risks relating to such syndrome, including 
        research into the prevention of such syndrome;
            (4) to conduct demonstration projects for the 
        prevention of such syndrome;
            (5) to provide technical assistance to public 
        entities, to nonprofit private entities concerned with 
        such syndrome, to schools, and to employers, for the 
        purpose of developing information programs relating to 
        such syndrome;
            (6) with respect to education and training programs 
        for the prevention of such syndrome, to conduct such 
        programs for health professionals (including allied 
        health professionals), public safety workers (including 
        emergency response employees), teachers, school 
        administrators, and other appropriate education 
        personnel;
            (7) to conduct appropriate programs for educating 
        school-aged children with respect to such syndrome, 
        after consulting with local school boards;
            (8) to make available to physicians and dentists in 
        the State information with respect to acquired immune 
        deficiency syndrome, including measures for the 
        prevention of exposure to, and the transmission of, the 
        etiologic agent for such syndrome (which information is 
        updated not less than annually with the most recently 
        available scientific date \1\ relating to such 
        syndrome);
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    \1\ So in law. Probably should be ``data''.
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            (9) to carry out the initial implementation of 
        recommendations contained in the guidelines and the 
        model curriculum developed under section 253 of the 
        AIDS Amendments of 1988; and
            (10) to make grants to public entities, and to 
        nonprofit private entities concerned with acquired 
        immune deficiency syndrome, for the purpose of the 
        development, establishment, and expansion of programs 
        for education directed toward individuals at increased 
        risk of infection with the etiologic agent for such 
        syndrome and activities to reduce the risks of exposure 
        to such etiologic agent, with preference to programs 
        directed toward populations in which there is 
        significant evidence of such infection.

 H4  deg.SEC. 2503. [300EE-13] REQUIREMENT OF SUBMISSION OF 
                    APPLICATION CONTAINING CERTAIN AGREEMENTS AND 
                    ASSURANCES.

    (a) In General.--The Secretary may not make payments under 
section 2501(a) for a fiscal year unless--
            (1) the State involved submits to the Secretary a 
        description of the purposes for which the State intends 
        to expend the payments for the fiscal year;
            (2) the description identifies the populations, 
        areas, and localities in the State with a need for the 
        services for which amounts may be provided by the State 
        under this part;
            (3) the description provides information relating 
        to the programs and activities to be supported and 
        services to be provided, including a description of the 
        manner in which such programs and activities will be 
        coordinated with any similar programs and activities of 
        public and private entities;
            (4) the State submits to the Secretary an 
        application for the payments containing agreements in 
        accordance with this part;
            (5) the agreements are made through certification 
        from the chief executive officer of the State;
            (6) with respect to such agreements, the 
        application provides assurances of compliance 
        satisfactory to the Secretary; and
            (7) the application otherwise is in such form, is 
        made in such manner, and contains such agreements, 
        assurances, and information as the Secretary determines 
        to be necessary to carry out this part.
    (b) Opportunity for Public Comment.--The Secretary may not 
make payments under section 2501(a) for a fiscal year unless 
the State involved agrees that, in developing and carrying out 
the description required in subsection (a), the State will 
provide public notice with respect to the description 
(including any revisions) and will facilitate comments from 
interested persons.

 H4  deg.SEC. 2504. [300EE-14] RESTRICTIONS ON USE OF GRANT.

    (a) In General.--The Secretary may not make payments under 
section 2501(a) for a fiscal year unless the State involved 
agrees that the payments will not be expended--
            (1) to provide inpatient services;
            (2) to make cash payments to intended recipients of 
        services;
            (3) to purchase or improve real property (other 
        than minor remodeling of existing improvements to real 
        property) or to purchase major medical equipment; or
            (4) to satisfy any requirement for the expenditure 
        of non-Federal funds as a condition for the receipt of 
        Federal funds.
    (b) Limitation on Administrative Expenses.--The Secretary 
may not make payments under section 2501(a) for a fiscal year 
unless the State involved agrees that the State will not expend 
more than 5 percent of the payments for administrative expenses 
with respect to carrying out the purpose described in section 
2501(b).

 H4  deg.SEC. 2505. [300EE-15] REQUIREMENT OF REPORTS AND 
                    AUDITS BY STATES.

    (a) Reports.--The Secretary may not make payments under 
section 2501(a) for a fiscal year unless the State involved 
agrees to prepare and submit to the Secretary an annual report 
in such form and containing such information as the Secretary 
determines to be necessary for--
            (1) securing a record and a description of the 
        purposes for which payments received by the State 
        pursuant to such section were expended and of the 
        recipients of such payments;
            (2) determining whether the payments were expended 
        in accordance with the needs within the State required 
        to be identified pursuant to section 2503(a)(2);
            (3) determining whether the payments were expended 
        in accordance with the purpose described in section 
        2501(b); and
            (4) determining the percentage of payments received 
        pursuant to such section that were expended by the 
        State for administrative expenses during the preceding 
        fiscal year.
    (b) Audits.--
            (1) The Secretary may not make payments under 
        section 2501(a) for a fiscal year unless the State 
        involved agrees to establish such fiscal control and 
        fund accounting procedures as may be necessary to 
        ensure the proper disbursal of, and accounting for, 
        amounts received by the State under such section.
            (2) The Secretary may not make payments under 
        section 2501(a) for a fiscal year unless the State 
        involved agrees that--
                    (A) the State will provide for--
                            (i) a financial and compliance 
                        audit of such payments; or
                            (ii) a single financial and 
                        compliance audit of each entity 
                        administering such payments;
                    (B) the audit will be performed biennially 
                and will cover expenditures in each fiscal 
                year; and
                    (C) the audit will be conducted in 
                accordance with standards established by the 
                Comptroller General of the United States for 
                the audit of governmental organizations, 
                programs, activities, and functions.
            (3) The Secretary may not make payments under 
        section 2501(a) for a fiscal year unless the State 
        involved agrees that, not later than 30 days after the 
        completion of an audit under paragraph (2), the State 
        will provide a copy of the audit report to the State 
        legislature.
            (4) For purposes of paragraph (2), the term 
        ``financial and compliance audit'' means an audit to 
        determine whether the financial statements of an 
        audited entity present fairly the financial position, 
        and the results of financial operations, of the entity 
        in accordance with generally accepted accounting 
        principles, and whether the entity has complied with 
        laws and regulations that may have a material effect 
        upon the financial statements.
    (c) Availability to Public.--The Secretary may not make 
payments under section 2501(a) for a fiscal year unless the 
State involved agrees to make copies of the reports and audits 
described in this section available for public inspection.
    (d) Evaluations by Comptroller General.--The Comptroller 
General of the United States shall, from time to time, evaluate 
the expenditures by States of payments received under section 
2501(a) in order to ensure that expenditures are consistent 
with the provisions of this part.

 H4  deg.SEC. 2506. [300EE-16] ADDITIONAL REQUIRED AGREEMENTS.

    (a) In General.--The Secretary may not, except as provided 
in subsection (b), make payments under section 2501(a) for a 
fiscal year unless the State involved agrees that--
            (1) all programs conducted or supported by the 
        State with such payments will establish objectives for 
        the program and will determine the extent to which the 
        objectives are met;
            (2) information provided under this part will be 
        scientifically accurate and factually correct;
            (3) in carrying out section 2501(b), the State will 
        give priority to programs described in section 2502(10) 
        for individuals described in such section;
            (4) with respect to a State in which there is a 
        substantial number of individuals who are intravenous 
        substance abusers, the State will place priority on 
        activities under this part directed at such substance 
        abusers;
            (5) with respect to a State in which there is a 
        significant incidence of reported cases of acquired 
        immune deficiency syndrome, the State will--
                    (A) for the purpose described in subsection 
                (b) of section 2501, expend not less than 50 
                percent of payments received under subsection 
                (a) of such section for a fiscal year--
                            (i) to make grants to public 
                        entities, to migrant health centers (as 
                        defined in section 329(a)), to 
                        community health centers (as defined in 
                        section 330(a)) \1\, and to nonprofit 
                        private entities concerned with 
                        acquired immune deficiency syndrome; or
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    \1\ See footnote for section 217(a).
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                            (ii) to enter into contracts with 
                        public and private entities; and
                    (B) of the amounts reserved for a fiscal 
                year by the State for expenditures required in 
                subparagraph (A), expend not less than 50 
                percent to carry out section 2502(10) through 
                grants to nonprofit private entities, including 
                minority entities, concerned with acquired 
                immune deficiency syndrome located in and 
                representative of communities and 
                subpopulations reflecting the local incidence 
                of such syndrome;
            (6) with respect to programs carried out pursuant 
        to section 2502(10), the State will ensure that any 
        applicant for a grant under such section agrees--
                    (A) that any educational or informational 
                materials developed with a grant pursuant to 
                such section will contain material, and be 
                presented in a manner, that is specifically 
                directed toward the group for which such 
                materials are intended;
                    (B) to provide a description of the manner 
                in which the applicant has planned the program 
                in consultation with, and of the manner in 
                which such applicant will consult during the 
                conduct of the program with--
                            (i) appropriate local officials and 
                        community groups for the area to be 
                        served by the program;
                            (ii) organizations comprised of, 
                        and representing, the specific 
                        population to which the education or 
                        prevention effort is to be directed; 
                        and
                            (iii) individuals having expertise 
                        in health education and in the needs of 
                        the population to be served;
                    (C) to provide information demonstrating 
                that the applicant has continuing 
                relationships, or will establish continuing 
                relationships, with a portion of the population 
                in the service area that is at risk of 
                infection with the etiologic agent for acquired 
                immune deficiency syndrome and with public and 
                private entities in such area that provide 
                health or other support services to individuals 
                with such infection;
                    (D) to provide a description of--
                            (i) the objectives established by 
                        the applicant for the conduct of the 
                        program; and
                            (ii) the methods the applicant will 
                        use to evaluate the activities 
                        conducted under the program to 
                        determine if such objectives are met; 
                        and
                    (E) such other information as the Secretary 
                may prescribe;
            (7) with respect to programs carried out pursuant 
        to section 2502(10), the State will give preference to 
        any applicant for a grant pursuant to such section that 
        is located in, has a history of service in, and will 
        serve under the program, any geographic area in which--
                    (A) there is a significant incidence of 
                acquired immune deficiency syndrome;
                    (B) there has been a significant increase 
                in the incidence of such syndrome; or
                    (C) there is a significant risk of becoming 
                infected with the etiologic agent for such 
                syndrome;
            (8) the State will establish reasonable criteria to 
        evaluate the effective performance of entities that 
        receive funds from payments made to the State under 
        section 2501(a) and will establish procedures for 
        procedural and substantive independent State review of 
        the failure by the State to provide funds for any such 
        entity;
            (9) the State will permit and cooperate with 
        Federal investigations undertaken in accordance with 
        section 2508(e);
            (10) the State will maintain State expenditures for 
        services provided pursuant to section 2501 at a level 
        equal to not less than the average level of such 
        expenditures maintained by the State for the 2-year 
        period preceding the fiscal year for which the State is 
        applying to receive payments.
    (b) Definition.--For purposes of subsection (a)(5), the 
term ``significant percentage'' means at least a percentage of 
1 percent of the number of reported cases of acquired immune 
deficiency syndrome in the United States.

 H4  deg.SEC. 2507. [300EE-17] DETERMINATION OF AMOUNT OF 
                    ALLOTMENTS FOR STATES.

    (a) Minimum Allotment.--Subject to the extent of amounts 
made available in appropriation Acts, the allotment for a State 
under section 2501(a) for a fiscal year shall be the greater 
of--
            (1) the applicable amount specified in subsection 
        (b); or
            (2) the amount determined in accordance with 
        subsection (c).
    (b) Determination of Minimum Allotment.--
            (1) If the total amount appropriated under section 
        2514(a) for a fiscal year exceeds $100,000,000, the 
        amount referred to in subsection (a)(1) shall be 
        $300,000 for the fiscal year.
            (2) If the total amount appropriated under section 
        2514(a) for a fiscal year equals or exceeds 
        $50,000,000, but is less than $100,000,000, the amount 
        referred to in subsection (a)(1) shall be $200,000 for 
        the fiscal year.
            (3) If the total amount appropriated under section 
        2514(a) for a fiscal year is less than $50,000,000, the 
        amount referred to in subsection (a)(1) shall be 
        $100,000 for the fiscal year.
    (c) Determination Under Formula.--
            (1) The amount referred to in subsection (a)(2) is 
        the sum of--
                    (A) the amount determined under paragraph 
                (2); and
                    (B) the amount determined under paragraph 
                (3).
            (2) The amount referred to in paragraph (1)(A) is 
        the product of--
                    (A) an amount equal to 50 percent of the 
                amounts appropriated pursuant to section 
                2514(a); and
                    (B) a percentage equal to the quotient of--
                            (i) the population of the State 
                        involved; divided by
                            (ii) the population of the United 
                        States.
            (3) The amount referred to in paragraph (1)(B) is 
        the product of--
                    (A) an amount equal to 50 percent of the 
                amounts appropriated pursuant to section 
                2514(a); and
                    (B) a percentage equal to the quotient of--
                            (i) the number of additional cases 
                        of acquired immune deficiency syndrome 
                        reported to and confirmed by the 
                        Secretary for the State involved for 
                        the most recent fiscal year for which 
                        such data is available; divided by
                            (ii) the number of additional cases 
                        of such syndrome reported to and 
                        confirmed by the Secretary for the 
                        United States for such fiscal year.
    (d) Disposition of Certain Funds Appropriated for 
Allotments.--
            (1) Amounts described in paragraph (2) shall be 
        allotted by the Secretary to States receiving payments 
        under section 2501(a) for the fiscal year (other than 
        any State referred to in paragraph (2)(C)). Such 
        amounts shall be allotted according to a formula 
        established by the Secretary. The formula shall be 
        equivalent to the formula described in this section 
        under which the allotment under section 2501(a) for the 
        State for the fiscal year involved was determined.
            (2) The amounts referred to in paragraph (1) are 
        any amounts that are not paid to States under section 
        2501(a) as a result of--
                    (A) the failure of any State to submit an 
                application under section 2503;
                    (B) the failure, in the determination of 
                the Secretary, of any State to prepare within a 
                reasonable period of time such application in 
                compliance with such section; or
                    (C) any State informing the Secretary that 
                the State does not intend to expend the full 
                amount of the allotment made to the State.

 H4  deg.SEC. 2508. [300EE-18] FAILURE TO COMPLY WITH 
                    AGREEMENTS.

    (a) Repayment of Payments.--
            (1) The Secretary may, subject to subsection (c), 
        require a State to repay any payments received by the 
        State under section 2501(a) that the Secretary 
        determines were not expended by the State in accordance 
        with the agreements required to be contained in the 
        application submitted by the State pursuant to section 
        2503.
            (2) If a State fails to make a repayment required 
        in paragraph (1), the Secretary may offset the amount 
        of the repayment against the amount of any payment due 
        to be paid to the State under section 2501(a).
    (b) Withholding of Payments.--
            (1) The Secretary may, subject to subsection (c), 
        withhold payments due under section 2501(a) if the 
        Secretary determines that the State involved is not 
        expending amounts received under such section in 
        accordance with the agreements required to be contained 
        in the application submitted by the State pursuant to 
        section 2503.
            (2) The Secretary shall cease withholding payments 
        from a State under paragraph (1) if the Secretary 
        determines that there are reasonable assurances that 
        the State will expend amounts received under section 
        2501(a) in accordance with the agreements referred to 
        in such paragraph.
            (3) The Secretary may not withhold funds under 
        paragraph (1) from a State for a minor failure to 
        comply with the agreements referred to in such 
        paragraph.
    (c) Opportunity for Hearing.--Before requiring repayment of 
payments under subsection (a)(1), or withholding payments under 
subsection (b)(1), the Secretary shall provide to the State an 
opportunity for a hearing conducted within the State.
    (d) Prompt Response to Serious Allegations.--The Secretary 
shall promptly respond to any complaint of a substantial or 
serious nature that a State has failed to expend amounts 
received under section 2501(a) in accordance with the 
agreements required to be contained in the application 
submitted by the State pursuant to section 2503.
    (e) Investigations.--
            (1) The Secretary shall conduct in several States 
        in each fiscal year investigations of the expenditure 
        of payments received by the States under section 
        2501(a) in order to evaluate compliance with the 
        agreements required to be contained in the applications 
        submitted to the Secretary pursuant to section 2503.
            (2) The Comptroller General of the United States 
        may conduct investigations of the expenditure of funds 
        received under section 2501(a) by a State in order to 
        ensure compliance with the agreements referred to in 
        paragraph (1).
            (3) Each State, and each entity receiving funds 
        from payments made to a State under section 2501(a), 
        shall make appropriate books, documents, papers, and 
        records available to the Secretary and the Comptroller 
        General of the United States, or any of their duly 
        authorized representatives, for examination, copying, 
        or mechanical reproduction on or off the premises of 
        the appropriate entity upon a reasonable request 
        therefor.
            (4)(A) In conducting any investigation in a State, 
        the Secretary and the Comptroller General of the United 
        States may not make a request for any information not 
        readily available to the State, or to an entity 
        receiving funds from payments made to the State under 
        section 2501(a), or make an unreasonable request for 
        information to be compiled, collected, or transmitted 
        in any form not readily available.
            (B) Subparagraph (A) shall not apply to the 
        collection, compilation, or transmittal of data in the 
        course of a judicial proceeding.

 H4  deg.SEC. 2509. [300EE-19] PROHIBITION AGAINST CERTAIN 
                    FALSE STATEMENTS.

    (a) In General.--
            (1) A person may not knowingly make or cause to be 
        made any false statement or representation of a 
        material fact in connection with the furnishing of 
        items or services for which amounts may be paid by a 
        State from payments received by the State under section 
        2501(a).
            (2) A person with knowledge of the occurrence of 
        any event affecting the right of the person to receive 
        any amounts from payments made to the State under 
        section 2501(a) may not conceal or fail to disclose any 
        such event with the intent of fraudulently securing 
        such amounts.
    (b) Criminal Penalty for Violation of Prohibition.--Any 
person who violates a prohibition established in subsection (a) 
may for each violation be fined in accordance with title 18, 
United States Code, or imprisoned for not more than 5 years, or 
both.

 H4  deg.SEC. 2510. [300EE-20] TECHNICAL ASSISTANCE AND 
                    PROVISION BY SECRETARY OF SUPPLIES AND SERVICES IN 
                    LIEU OF GRANT FUNDS.

    (a) Technical Assistance.--The Secretary may provide 
training and technical assistance to States with respect to the 
planning, development, and operation of any program or service 
carried out pursuant to this part. The Secretary may provide 
such technical assistance directly or through grants or 
contracts.
    (b) Provision by Secretary of Supplies and Services in Lieu 
of Grant Funds.--
            (1) Upon the request of a State receiving payments 
        under this part, the Secretary may, subject to 
        paragraph (2), provide supplies, equipment, and 
        services for the purpose of aiding the State in 
        carrying out such part and, for such purpose, may 
        detail to the State any officer or employee of the 
        Department of Health and Human Services.
            (2) With respect to a request described in 
        paragraph (1), the Secretary shall reduce the amount of 
        payments under section 2501(a) to the State by an 
        amount equal to the costs of detailing personnel and 
        the fair market value of any supplies, equipment, or 
        services provided by the Secretary. The Secretary 
        shall, for the payment of expenses incurred in 
        complying with such request, expend the amounts 
        withheld.

 H4  deg.SEC. 2511. [300EE-21] EVALUATIONS.

    The Secretary shall, directly or through grants or 
contracts, evaluate the services provided and activities 
carried out with payments to States under this part.

 H4  deg.SEC. 2512. [300EE-22] REPORT BY SECRETARY.

    The Secretary shall annually prepare a report on the 
activities of the States carried out pursuant to this part. 
Such report may include any recommendations of the Secretary 
for appropriate administrative and legislative initiatives. The 
report shall be submitted to the Congress through inclusion in 
the comprehensive report required in section 2301(a).

 H4  deg.SEC. 2513. [300EE-23] DEFINITION.

    For purposes of this part, the term ``infection with the 
etiologic agent for acquired immune deficiency syndrome'' 
includes any condition arising from such etiologic agent.

 H4  deg.SEC. 2514. [300EE-24] FUNDING.

    (a) Authorization of Appropriations.--For the purpose of 
making allotments under section 2501(a), there are authorized 
to be appropriated $165,000,000 for fiscal year 1989 and such 
sums as may be necessary for each of the fiscal years 1990 and 
1991.
    (b) Availability to States.--Any amounts paid to a State 
under section 2501(a) shall remain available to the State until 
the expiration of the 1-year period beginning on the date on 
which the State receives such amounts.

         H2  deg.Part B--National Information Programs

 H4  deg.SEC. 2521. [300EE-31] AVAILABILITY OF INFORMATION TO 
                    GENERAL PUBLIC.

    (a) Comprehensive Information Plan.--The Secretary, acting 
through the Director of the Centers for Disease Control and 
Prevention, shall annually prepare a comprehensive plan, 
including a budget, for a National Acquired Immune Deficiency 
Syndrome Information Program. The plan shall contain provisions 
to implement the provisions of this title. The Director shall 
submit such plan to the Secretary. The authority established in 
this subsection may not be construed to be the exclusive 
authority for the Director to carry out information activities 
with respect to acquired immune deficiency syndrome.
    (b) Clearinghouse.--
            (1) The Secretary, acting through the Director of 
        the Centers for Disease Control and Prevention, may 
        establish a clearinghouse to make information 
        concerning acquired immune deficiency syndrome 
        available to Federal agencies, States, public and 
        private entities, and the general public.
            (2) The clearinghouse may conduct or support 
        programs--
                    (A) to develop and obtain educational 
                materials, model curricula, and methods 
                directed toward reducing the transmission of 
                the etiologic agent for acquired immune 
                deficiency syndrome;
                    (B) to provide instruction and support for 
                individuals who provide instruction in methods 
                and techniques of education relating to the 
                prevention of acquired immune deficiency 
                syndrome and instruction in the use of the 
                materials and curricula described in 
                subparagraph (A); and
                    (C) to conduct, or to provide for the 
                conduct of, the materials, curricula, and 
                methods described in paragraph (1) and the 
                efficacy of such materials, curricula, and 
                methods in preventing infection with the the 
                \1\ etiologic agent for acquired immune 
                deficiency syndrome.
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    \1\ So in law. The word ``the'' appears twice.
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    (c) Toll-Free Telephone Communications.--The Secretary 
shall provide for the establishment and maintenance of toll-
free telephone communications to provide information to, and 
respond to queries from, the public concerning acquired immune 
deficiency syndrome. Such communications shall be available on 
a 24-hour basis.

 H4  deg.SEC. 2522. [300EE-32] PUBLIC INFORMATION CAMPAIGNS.

    (a) In General.--The Secretary, acting through the Director 
of the Centers for Disease Control and Prevention, may make 
grants to public entities, and to nonprofit private entities 
concerned with acquired immune deficiency syndrome, and shall 
enter into contracts with public and private entities, for the 
development and delivery of public service announcements and 
paid advertising messages that warn individuals about 
activities which place them at risk of infection with the 
etiologic agent for such syndrome.
    (b) Requirement of Application.--The Secretary may not 
provide financial assistance under subsection (a) unless--
            (1) an application for such assistance is submitted 
        to the Secretary;
            (2) with respect to carrying out the purpose for 
        which the assistance is to be provided, the application 
        provides assurances of compliance satisfactory to the 
        Secretary; and
            (3) the application otherwise is in such form, is 
        made in such manner, and contains such agreements, 
        assurances, and information as the Secretary determines 
        to be necessary to carry out this section.

 H4  deg.SEC. 2523. [300EE-33] PROVISION OF INFORMATION TO 
                    UNDERSERVED POPULATIONS.

    (a) In General.--The Secretary may make grants to public 
entities, to migrant health centers (as defined in section 
329(a) \2\), to community health centers (as defined in section 
330(a)) \2\, and to nonprofit private entities concerned with 
acquired immune deficiency syndrome, for the purpose of 
assisting grantees in providing services to populations of 
individuals that are underserved with respect to programs 
providing information on the prevention of exposure to, and the 
transmission of, the etiologic agent for acquired immune 
deficiency syndrome.
---------------------------------------------------------------------------
    \2\ See footnote for section 217(a).
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    (b) Preferences in Making Grants.--In making grants under 
subsection (a), the Secretary shall give preference to any 
applicant for such a grant that has the ability to disseminate 
rapidly the information described in subsection (a) (including 
any national organization with such ability).

 H4  deg.SEC. 2524. [300EE-34] AUTHORIZATION OF 
                    APPROPRIATIONS.

    (a) In General.--For the purpose of carrying out sections 
2521 through 2523, there are authorized to be appropriated 
$105,000,000 for fiscal year 1989 and such sums as may be 
necessary for each of the fiscal years 1990 and 1991.
    (b) Allocations.--
            (1) Of the amounts appropriated pursuant to 
        subsection (a), the Secretary shall make available 
        $45,000,000 to carry out section 2522 and $30,000,000 
        to carry out this part through financial assistance to 
        minority entities for the provision of services to 
        minority populations.
            (2) After consultation with the Director of the 
        Office of Minority Health and with the Indian Health 
        Service, the Secretary, acting through the Director of 
        the Centers for Disease Control and Prevention, shall, 
        not later than 90 days after the date of the enactment 
        of the AIDS Amendments of 1988, \1\ publish guidelines 
        to provide procedures for applications for funding 
        pursuant to paragraph (1) and for public comment.
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    \1\ Enacted on November 4, 1988.ATTORNEY: PMG/FD (June 24, 
1999) deg.
      TITLE XXVI--HIV HEALTH CARE SERVICES PROGRAM 1, 2

 Part A--Emergency Relief for Areas With Substantial Need for Services 
                                  \3\

                  Subpart I--General Grant Provisions

SEC. 2601. [300FF-11] ESTABLISHMENT OF PROGRAM OF GRANTS.

    (a) Eligible Areas.--The Secretary, acting through the 
Administrator of the Health Resources and Services 
Administration, shall, subject to subsections (b) through (c), 
make grants in accordance with section 2603 for the purpose of 
assisting in the provision of the services specified in section 
2604 in any metropolitan area for which there has been reported 
to and confirmed by the Director of the Centers for Disease 
Control and Prevention a cumulative total of more than 2,000 
cases of AIDS during the most recent period of 5 calendar years 
for which such data are available.
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    \1\ This title was added by Public Law 101-381. Section 2 of that 
Public Law provides as follows: ``It is the purpose of this Act to 
provide emergency assistance to localities that are disproportionately 
affected by the Human Immunodeficiency Virus epidemic and to make 
financial assistance available to States and other public or private 
nonprofit entities to provide for the development, organization, 
coordination and operation of more effective and cost efficient systems 
for the delivery of essential services to individuals and families with 
HIV disease.''.
    \2\ Section 502 of Public Law 106-345 (114 Stat. 1353) relates to 
the development of reliable and affordable tests for HIV disease that 
can rapidly be administered and whose results can rapidly be obtained.
    \3\ With respect to information for determining formula grants 
under parts A and B, section 501(a) of Public Law 106-345 (114 Stat. 
1352) provides for a study of State surveillance systems regarding 
cases of infection with the human immunodeficiency virus. Section 
501(d)(1) of such Law requires that a report of the findings of the 
study be submitted not later than 3 years after the date of the 
enactment of the Law, which was enacted October 20, 2000.
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    (b) Continued Status as Eligible Area.--Notwithstanding any 
other provision of this section, a metropolitan area that is an 
eligible area for a fiscal year continues to be an eligible 
area until the metropolitan area fails, for three consecutive 
fiscal years--
            (1) to meet the requirements of subsection (a); and
            (2) to have a cumulative total of 3,000 or more 
        living cases of AIDS (reported to and confirmed by the 
        Director of the Centers for Disease Control and 
        Prevention) as of December 31 of the most recent 
        calendar year for which such data is available.
    (c) Boundaries.--For purposes of determining eligibility 
under this subpart--
            (1) with respect to a metropolitan area that 
        received funding under this subpart in fiscal year 
        2006, the boundaries of such metropolitan area shall be 
        the boundaries that were in effect for such area for 
        fiscal year 1994; or
            (2) with respect to a metropolitan area that 
        becomes eligible to receive funding under this subpart 
        in any fiscal year after fiscal year 2006, the 
        boundaries of such metropolitan area shall be the 
        boundaries that are in effect for such area when such 
        area initially receives funding under this subpart.

SEC. 2602. [300FF-12] ADMINISTRATION AND PLANNING COUNCIL.

    (a) Administration.--
            (1) In general.--Assistance made available under 
        grants awarded under this subpart shall be directed to 
        the chief elected official of the city or urban county 
        that administers the public health agency that provides 
        outpatient and ambulatory services to the greatest 
        number of individuals with AIDS, as reported to and 
        confirmed by the Centers for Disease Control and 
        Prevention, in the eligible area that is awarded such a 
        grant.
            (2) Requirements.--
                    (A) In general.--To receive assistance 
                under section 2601(a), the chief elected 
                official of the eligible area involved shall--
                            (i) establish, through 
                        intergovernmental agreements with the 
                        chief elected officials of the 
                        political subdivisions described in 
                        subparagraph (B), an administrative 
                        mechanism to allocate funds and 
                        services based on--
                                    (I) the number of AIDS 
                                cases in such subdivisions;
                                    (II) the severity of need 
                                for outpatient and ambulatory 
                                care services in such 
                                subdivisions; and
                                    (III) the health and 
                                support services personnel 
                                needs of such subdivisions; and
                            (ii) establish an HIV health 
                        services planning council in accordance 
                        with subsection (b).
                    (B) Local political subdivision.--The 
                political subdivisions referred to in 
                subparagraph (A) are those political 
                subdivisions in the eligible area--
                            (i) that provide HIV-related health 
                        services; and
                            (ii) for which the number of cases 
                        reported for purposes of section 
                        2601(a) constitutes not less than 10 
                        percent of the number of such cases 
                        reported for the eligible area.
    (b) HIV Health Services Planning Council.--
            (1) Establishment.--To be eligible for assistance 
        under this subpart, the chief elected official 
        described in subsection (a)(1) shall establish or 
        designate an HIV health services planning council that 
        shall reflect in its composition the demographics of 
        the population of individuals with HIV/AIDS in the 
        eligible area involved, with particular consideration 
        given to disproportionately affected and historically 
        underserved groups and subpopulations. Nominations for 
        membership on the council shall be identified through 
        an open process and candidates shall be selected based 
        on locally delineated and publicized criteria. Such 
        criteria shall include a conflict-of-interest standard 
        that is in accordance with paragraph (5).
            (2) Representation.--The HIV health services 
        planning council shall include representatives of--
                    (A) health care providers, including 
                federally qualified health centers;
                    (B) community-based organizations serving 
                affected populations and AIDS service 
                organizations;
                    (C) social service providers, including 
                providers of housing and homeless services;
                    (D) mental health and substance abuse 
                providers;
                    (E) local public health agencies;
                    (F) hospital planning agencies or health 
                care planning agencies;
                    (G) affected communities, including people 
                with HIV/AIDS, members of a Federally 
                recognized Indian tribe as represented in the 
                population, individuals co-infected with 
                hepatitis B or C and historically underserved 
                groups and subpopulations;
                    (H) nonelected community leaders;
                    (I) State government (including the State 
                medicaid agency and the agency administering 
                the program under part B);
                    (J) grantees under subpart II of part C;
                    (K) grantees under section 2671, or, if 
                none are operating in the area, representatives 
                of organizations with a history of serving 
                children, youth, women, and families living 
                with HIV and operating in the area;
                    (L) grantees under other Federal HIV 
                programs, including but not limited to 
                providers of HIV prevention services; and
                    (M) representatives of individuals who 
                formerly were Federal, State, or local 
                prisoners, were released from the custody of 
                the penal system during the preceding 3 years, 
                and had HIV/AIDS as of the date on which the 
                individuals were so released.
            (3) Method of providing for council.--
                    (A) In general.--In providing for a council 
                for purposes of paragraph (1), a chief elected 
                official receiving a grant under section 
                2601(a) may establish the council directly or 
                designate an existing entity to serve as the 
                council, subject to subparagraph (B).
                    (B) Consideration regarding designation of 
                council.--In making a determination of whether 
                to establish or designate a council under 
                subparagraph (A), a chief elected official 
                receiving a grant under section 2601(a) shall 
                give priority to the designation of an existing 
                entity that has demonstrated experience in 
                planning for the HIV health care service needs 
                within the eligible area and in the 
                implementation of such plans in addressing 
                those needs. Any existing entity so designated 
                shall be expanded to include a broad 
                representation of the full range of entities 
                that provide such services within the 
                geographic area to be served.
            (4) Duties.--The planning council established or 
        designated under paragraph (1) shall--
                    (A) determine the size and demographics of 
                the population of individuals with HIV/AIDS, as 
                well as the size and demographics of the 
                estimated population of individuals with HIV/
                AIDS who are unaware of their HIV status;
                    (B) determine the needs of such population, 
                with particular attention to--
                            (i) individuals with HIV/AIDS who 
                        know their HIV status and are not 
                        receiving HIV-related services;
                            (ii) disparities in access and 
                        services among affected subpopulations 
                        and historically underserved 
                        communities; and
                            (iii) individuals with HIV/AIDS who 
                        do not know their HIV status;
                    (C) establish priorities for the allocation 
                of funds within the eligible area, including 
                how best to meet each such priority and 
                additional factors that a grantee should 
                consider in allocating funds under a grant 
                based on the--
                            (i) size and demographics of the 
                        population of individuals with HIV/AIDS 
                        (as determined under subparagraph (A)) 
                        and the needs of such population (as 
                        determined under subparagraph (B));
                            (ii) demonstrated (or probable) 
                        cost effectiveness and outcome 
                        effectiveness of proposed strategies 
                        and interventions, to the extent that 
                        data are reasonably available;
                            (iii) priorities of the communities 
                        with HIV/AIDS for whom the services are 
                        intended;
                            (iv) coordination in the provision 
                        of services to such individuals with 
                        programs for HIV prevention and for the 
                        prevention and treatment of substance 
                        abuse, including programs that provide 
                        comprehensive treatment for such abuse;
                            (v) availability of other 
                        governmental and non-governmental 
                        resources, including the State medicaid 
                        plan under title XIX of the Social 
                        Security Act and the State Children's 
                        Health Insurance Program under title 
                        XXI of such Act to cover health care 
                        costs of eligible individuals and 
                        families with HIV/AIDS; and
                            (vi) capacity development needs 
                        resulting from disparities in the 
                        availability of HIV-related services in 
                        historically underserved communities;
                    (D) develop a comprehensive plan for the 
                organization and delivery of health and support 
                services described in section 2604 that--
                            (i) includes a strategy for 
                        identifying individuals who know their 
                        HIV status and are not receiving such 
                        services and for informing the 
                        individuals of and enabling the 
                        individuals to utilize the services, 
                        giving particular attention to 
                        eliminating disparities in access and 
                        services among affected subpopulations 
                        and historically underserved 
                        communities, and including discrete 
                        goals, a timetable, and an appropriate 
                        allocation of funds;
                            (ii) includes a strategy to 
                        coordinate the provision of such 
                        services with programs for HIV 
                        prevention (including outreach and 
                        early intervention) and for the 
                        prevention and treatment of substance 
                        abuse (including programs that provide 
                        comprehensive treatment services for 
                        such abuse);
                            (iii) is compatible with any State 
                        or local plan for the provision of 
                        services to individuals with HIV/AIDS; 
                        and
                            (iv) includes a strategy, 
                        coordinated as appropriate with other 
                        community strategies and efforts, 
                        including discrete goals, a timetable, 
                        and appropriate funding, for 
                        identifying individuals with HIV/AIDS 
                        who do not know their HIV status, 
                        making such individuals aware of such 
                        status, and enabling such individuals 
                        to use the health and support services 
                        described in section 2604, with 
                        particular attention to reducing 
                        barriers to routine testing and 
                        disparities in access and services 
                        among affected subpopulations and 
                        historically underserved communities;
                    (E) assess the efficiency of the 
                administrative mechanism in rapidly allocating 
                funds to the areas of greatest need within the 
                eligible area, and at the discretion of the 
                planning council, assess the effectiveness, 
                either directly or through contractual 
                arrangements, of the services offered in 
                meeting the identified needs;
                    (F) participate in the development of the 
                statewide coordinated statement of need 
                initiated by the State public health agency 
                responsible for administering grants under part 
                B;
                    (G) establish methods for obtaining input 
                on community needs and priorities which may 
                include public meetings (in accordance with 
                paragraph (7)), conducting focus groups, and 
                convening ad-hoc panels; and
                    (H) coordinate with Federal grantees that 
                provide HIV-related services within the 
                eligible area.
            (5) Conflicts of interest.--
                    (A) In general.--The planning council under 
                paragraph (1) may not be directly involved in 
                the administration of a grant under section 
                2601(a). With respect to compliance with the 
                preceding sentence, the planning council may 
                not designate (or otherwise be involved in the 
                selection of) particular entities as recipients 
                of any of the amounts provided in the grant.
                    (B) Required agreements.--An individual may 
                serve on the planning council under paragraph 
                (1) only if the individual agrees that if the 
                individual has a financial interest in an 
                entity, if the individual is an employee of a 
                public or private entity, or if the individual 
                is a member of a public or private 
                organization, and such entity or organization 
                is seeking amounts from a grant under section 
                2601(a), the individual will not, with respect 
                to the purpose for which the entity seeks such 
                amounts, participate (directly or in an 
                advisory capacity) in the process of selecting 
                entities to receive such amounts for such 
                purpose.
                    (C) Composition of council.--The following 
                applies regarding the membership of a planning 
                council under paragraph (1):
                            (i) Not less than 33 percent of the 
                        council shall be individuals who are 
                        receiving HIV-related services pursuant 
                        to a grant under section 2601(a), are 
                        not officers, employees, or consultants 
                        to any entity that receives amounts 
                        from such a grant, and do not represent 
                        any such entity, and reflect the 
                        demographics of the population of 
                        individuals with HIV/AIDS as determined 
                        under paragraph (4)(A). For purposes of 
                        the preceding sentence, an individual 
                        shall be considered to be receiving 
                        such services if the individual is a 
                        parent of, or a caregiver for, a minor 
                        child who is receiving such services.
                            (ii) With respect to membership on 
                        the planning council, clause (i) may 
                        not be construed as having any effect 
                        on entities that receive funds from 
                        grants under any of parts B through F 
                        but do not receive funds from grants 
                        under section 2601(a), on officers or 
                        employees of such entities, or on 
                        individuals who represent such 
                        entities.
            (6) Grievance procedures.--A planning council under 
        paragraph (1) shall develop procedures for addressing 
        grievances with respect to funding under this subpart, 
        including procedures for submitting grievances that 
        cannot be resolved to binding arbitration. Such 
        procedures shall be described in the by-laws of the 
        planning council and be consistent with the 
        requirements of subsection (c).
            (7) Public deliberations.--With respect to a 
        planning council under paragraph (1), the following 
        applies:
                    (A) The council may not be chaired solely 
                by an employee of the grantee under section 
                2601(a).
                    (B) In accordance with criteria established 
                by the Secretary:
                            (i) The meetings of the council 
                        shall be open to the public and shall 
                        be held only after adequate notice to 
                        the public.
                            (ii) The records, reports, 
                        transcripts, minutes, agenda, or other 
                        documents which were made available to 
                        or prepared for or by the council shall 
                        be available for public inspection and 
                        copying at a single location.
                            (iii) Detailed minutes of each 
                        meeting of the council shall be kept. 
                        The accuracy of all minutes shall be 
                        certified to by the chair of the 
                        council.
                            (iv) This subparagraph does not 
                        apply to any disclosure of information 
                        of a personal nature that would 
                        constitute a clearly unwarranted 
                        invasion of personal privacy, including 
                        any disclosure of medical information 
                        or personnel matters.
    (c) \1\ Grievance Procedures.--
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    \1\ Subsection (c) was added by an amendment to subsection (b). 
Section 3(b)(1)(F) of Public Law 104-146 (110 Stat. 1348) provided that 
subsection (b) of section 2602 is amended ``by adding at the end 
thereof the following:'', and then added paragraphs (5) and (6) and 
subsection (c).
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            (1) Federal responsibility.--
                    (A) Models.--The Secretary shall, through a 
                process that includes consultations with 
                grantees under this subpart and public and 
                private experts in grievance procedures, 
                arbitration, and mediation, develop model 
                grievance procedures that may be implemented by 
                the planning council under subsection (b)(1) 
                and grantees under this subpart. Such model 
                procedures shall describe the elements that 
                must be addressed in establishing local 
                grievance procedures and provide grantees with 
                flexibility in the design of such local 
                procedures.
                    (B) Review.--The Secretary shall review 
                grievance procedures established by the 
                planning council and grantees under this 
                subpart to determine if such procedures are 
                adequate. In making such a determination, the 
                Secretary shall assess whether such procedures 
                permit legitimate grievances to be filed, 
                evaluated, and resolved at the local level.
            (2) Grantees.--To be eligible to receive funds 
        under this subpart, a grantee shall develop grievance 
        procedures that are determined by the Secretary to be 
        consistent with the model procedures developed under 
        paragraph (1)(A). Such procedures shall include a 
        process for submitting grievances to binding 
        arbitration.
    (d) Process for Establishing Allocation Priorities.--
Promptly after the date of the submission of the report 
required in section 501(b) of the Ryan White CARE Act 
Amendments of 2000 \1\ (relating to the relationship between 
epidemiological measures and health care for certain 
individuals with HIV/AIDS), the Secretary, in consultation with 
planning councils and entities that receive amounts from grants 
under section 2601(a) or 2611, shall develop epidemiologic 
measures--
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    \1\ Public Law 106-345 (114 Stat. 1352). Section 501(d)(2) of such 
Law requires that the report be submitted not later than 2 years after 
the date of the enactment of the Law, which was enacted October 20, 
2000.
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            (1) for establishing the number of individuals 
        living with HIV/AIDS who are not receiving HIV-related 
        health services; and
            (2) for carrying out the duties under subsection 
        (b)(4) and section 2617(b).
    (e) Training Guidance and Materials.--The Secretary shall 
provide to each chief elected official receiving a grant under 
section 2601(a) guidelines and materials for training members 
of the planning council under paragraph (1) regarding the 
duties of the council.

SEC. 2603. [300FF-13] TYPE AND DISTRIBUTION OF GRANTS.

    (a) Grants Based on Relative Need of Area.--
            (1) In general.--In carrying out section 2601(a), 
        the Secretary shall make a grant for each eligible area 
        for which an application under section 2605(a) has been 
        approved. Each such grant shall be made in an amount 
        determined in accordance with paragraph (3).
            (2) Expedited distribution.--Not later than 60 days 
        after an appropriation becomes available to carry out 
        this subpart for a fiscal year, the Secretary shall, 
        except in the case of waivers granted under section 
        2605(c), disburse 66\2/3\ percent of the amount made 
        available under section 2610(b) for carrying out this 
        subpart for such fiscal year through grants to eligible 
        areas under section 2601(a), in accordance with 
        paragraphs (3) and (4).
            (3) Amount of grant.--
                    (A) In general.--Subject to the extent of 
                amounts made available in appropriations Acts, 
                a grant made for purposes of this paragraph to 
                an eligible area shall be made in an amount 
                equal to the product of--
                            (i) an amount equal to the amount 
                        available for distribution under 
                        paragraph (2) for the fiscal year 
                        involved; and
                            (ii) the percentage constituted by 
                        the ratio of the distribution factor 
                        for the eligible area to the sum of the 
                        respective distribution factors for all 
                        eligible areas;
                which product shall then, as applicable, be 
                increased under paragraph (4).
                    (B) Distribution factor.--For purposes of 
                subparagraph (A)(ii), the term ``distribution 
                factor'' means an amount equal to the estimated 
                number of living cases of AIDS \1\ in the 
                eligible area involved, as determined under 
                subparagraph (C).
---------------------------------------------------------------------------
    \1\ Section 102(b)(1) of Public Law 109-415 provides as follows:

          (1) in subparagraph (B), by striking ``estimated living cases 
        of acquired immune deficiency syndrome'' and inserting ``living 
        cases of HIV/AIDS (reported to and confirmed by the Director of 
---------------------------------------------------------------------------
        the Centers for Disease Control and Prevention)''; and

     Such amendment could not be executed because the words ``number 
of'' probably should appear before ``living cases'' in the matter 
purported to be struck.
---------------------------------------------------------------------------
                    (C) Living cases of hiv/aids.--
                            (i) Requirement of names-based 
                        reporting.--Except as provided in 
                        clause (ii), the number determined 
                        under this subparagraph for an eligible 
                        area for a fiscal year for purposes of 
                        subparagraph (B) is the number of 
                        living names-based cases of HIV/AIDS 
                        that, as of December 31 of the most 
                        recent calendar year for which such 
                        data is available, have been reported 
                        to and confirmed by the Director of the 
                        Centers for Disease Control and 
                        Prevention.
                            (ii) Transition period; exemption 
                        regarding non-aids cases.--For each of 
                        the fiscal years 2007 through 2012, an 
                        eligible area is, subject to clauses 
                        (iii) through (v), exempt from the 
                        requirement under clause (i) that 
                        living names-based non-AIDS cases of 
                        HIV be reported unless--
                                    (I) a system was in 
                                operation as of December 31, 
                                2005, that provides 
                                sufficiently accurate and 
                                reliable names-based reporting 
                                of such cases throughout the 
                                State in which the area is 
                                located, subject to clause 
                                (viii); or
                                    (II) no later than the 
                                beginning of fiscal year 2008 
                                or a subsequent fiscal year 
                                through fiscal year 2012, the 
                                Secretary, in consultation with 
                                the chief executive of the 
                                State in which the area is 
                                located, determines that a 
                                system has become operational 
                                in the State that provides 
                                sufficiently accurate and 
                                reliable names-based reporting 
                                of such cases throughout the 
                                State.
                            (iii) Requirements for exemption 
                        for fiscal year 2007.--For fiscal year 
                        2007, an exemption under clause (ii) 
                        for an eligible area applies only if, 
                        by October 1, 2006--
                                    (I)(aa) the State in which 
                                the area is located had 
                                submitted to the Secretary a 
                                plan for making the transition 
                                to sufficiently accurate and 
                                reliable names-based reporting 
                                of living non-AIDS cases of 
                                HIV; or
                                    (bb) all statutory changes 
                                necessary to provide for 
                                sufficiently accurate and 
                                reliable reporting of such 
                                cases had been made; and
                                    (II) the State had agreed 
                                that, by April 1, 2008, the 
                                State will begin accurate and 
                                reliable names-based reporting 
                                of such cases, except that such 
                                agreement is not required to 
                                provide that, as of such date, 
                                the system for such reporting 
                                be fully sufficient with 
                                respect to accuracy and 
                                reliability throughout the 
                                area.
                            (iv) Requirement for exemption as 
                        of fiscal year 2008.--For each of the 
                        fiscal years 2008 through 2012, an 
                        exemption under clause (ii) for an 
                        eligible area applies only if, as of 
                        April 1, 2008, the State in which the 
                        area is located is substantially in 
                        compliance with the agreement under 
                        clause (iii)(II).
                            (v) Progress toward names-based 
                        reporting.--For fiscal year 2009 or a 
                        subsequent fiscal year, the Secretary 
                        may terminate an exemption under clause 
                        (ii) for an eligible area if the State 
                        in which the area is located submitted 
                        a plan under clause (iii)(I)(aa) and 
                        the Secretary determines that the State 
                        is not substantially following the 
                        plan.
                            (vi) Counting of cases in areas 
                        with exemptions.--
                                    (I) In general.--With 
                                respect to an eligible area 
                                that is under a reporting 
                                system for living non-AIDS 
                                cases of HIV that is not names-
                                based (referred to in this 
                                subparagraph as ``code-based 
                                reporting''), the Secretary 
                                shall, for purposes of this 
                                subparagraph, modify the number 
                                of such cases reported for the 
                                eligible area in order to 
                                adjust for duplicative 
                                reporting in and among systems 
                                that use code-based reporting.
                                    (II) Adjustment rate.--The 
                                adjustment rate under subclause 
                                (I) for an eligible area shall 
                                be a reduction of 5 percent for 
                                fiscal years before fiscal year 
                                2012 (and 6 percent for fiscal 
                                year 2012) in the number of 
                                living non-AIDS cases of HIV 
                                reported for the area.
                                    (III) Increased adjustment 
                                for certain areas previously 
                                using code-based reporting.--
                                For purposes of this 
                                subparagraph for each of fiscal 
                                years 2010 through 2012, the 
                                Secretary shall deem the 
                                applicable number of living 
                                cases of HIV/AIDS in an area 
                                that were reported to and 
                                confirmed by the Centers for 
                                Disease Control and Prevention 
                                to be 3 percent higher than the 
                                actual number if--
                                            (aa) for fiscal 
                                        year 2007, such area 
                                        was a transitional 
                                        area;
                                            (bb) fiscal year 
                                        2007 was the first year 
                                        in which the count of 
                                        living non-AIDS cases 
                                        of HIV in such area, 
                                        for purposes of this 
                                        section, was based on a 
                                        names-based reporting 
                                        system; and
                                            (cc) the amount of 
                                        funding that such area 
                                        received under this 
                                        part for fiscal year 
                                        2007 was less than 70 
                                        percent of the amount 
                                        of funding (exclusive 
                                        of funds that were 
                                        identified as being for 
                                        purposes of the 
                                        Minority AIDS 
                                        Initiative) that such 
                                        area received under 
                                        such part for fiscal 
                                        year 2006.
                            (vii) Multiple political 
                        jurisdictions.--With respect to living 
                        non-AIDS cases of HIV, if an eligible 
                        area is not entirely within one 
                        political jurisdiction and as a result 
                        is subject to more than one reporting 
                        system for purposes of this 
                        subparagraph:
                                    (I) Names-based reporting 
                                under clause (i) applies in a 
                                jurisdictional portion of the 
                                area, or an exemption under 
                                clause (ii) applies in such 
                                portion (subject to applicable 
                                provisions of this 
                                subparagraph), according to 
                                whether names-based reporting 
                                or code-based reporting is used 
                                in such portion.
                                    (II) If under subclause (I) 
                                both names-based reporting and 
                                code-based reporting apply in 
                                the area, the number of code-
                                based cases shall be reduced 
                                under clause (vi).
                            (viii) List of eligible areas 
                        meeting standard regarding December 31, 
                        2005.--
                                    (I) In general.--If an 
                                eligible area or portion 
                                thereof is in a State specified 
                                in subclause (II), the eligible 
                                area or portion shall be 
                                considered to meet the standard 
                                described in clause (ii)(I). No 
                                other eligible area or portion 
                                thereof may be considered to 
                                meet such standard.
                                    (II) Relevant states.--For 
                                purposes of subclause (I), the 
                                States specified in this 
                                subclause are the following: 
                                Alaska, Alabama, Arkansas, 
                                Arizona, Colorado, Florida, 
                                Indiana, Iowa, Idaho, Kansas, 
                                Louisiana, Michigan, Minnesota, 
                                Missouri, Mississippi, North 
                                Carolina, North Dakota, 
                                Nebraska, New Jersey, New 
                                Mexico, New York, Nevada, Ohio, 
                                Oklahoma, South Carolina, South 
                                Dakota, Tennessee, Texas, Utah, 
                                Virginia, Wisconsin, West 
                                Virginia, Wyoming, Guam, and 
                                the Virgin Islands.
                            (ix) Rules of construction 
                        regarding acceptance of reports.--
                                    (I) Cases of aids.--With 
                                respect to an eligible area 
                                that is subject to the 
                                requirement under clause (i) 
                                and is not in compliance with 
                                the requirement for names-based 
                                reporting of living non-AIDS 
                                cases of HIV, the Secretary 
                                shall, notwithstanding such 
                                noncompliance, accept reports 
                                of living cases of AIDS that 
                                are in accordance with such 
                                clause.
                                    (II) Applicability of 
                                exemption requirements.--The 
                                provisions of clauses (ii) 
                                through (viii) may not be 
                                construed as having any legal 
                                effect for fiscal year 2013 or 
                                any subsequent fiscal year, and 
                                accordingly, the status of a 
                                State for purposes of such 
                                clauses may not be considered 
                                after fiscal year 2012.
                            (x) Program for detecting 
                        inaccurate or fraudulent counting.--The 
                        Secretary shall carry out a program to 
                        monitor the reporting of names-based 
                        cases for purposes of this subparagraph 
                        and to detect instances of inaccurate 
                        reporting, including fraudulent 
                        reporting.
                            (xi) Future fiscal years.--For 
                        fiscal years beginning with fiscal year 
                        2013, determinations under this 
                        paragraph shall be based only on living 
                        names-based cases of HIV/AIDS with 
                        respect to the area involved.
                    (D) Code-based areas; limitation on 
                increase in grant .--
                            (i) In general.--For each of the 
                        fiscal years 2007 through 2012, if 
                        code-based reporting (within the 
                        meaning of subparagraph (C)(vi)) 
                        applies in an eligible area or any 
                        portion thereof as of the beginning of 
                        the fiscal year involved, then 
                        notwithstanding any other provision of 
                        this paragraph, the amount of the grant 
                        pursuant to this paragraph for such 
                        area for such fiscal year may not--
                                    (I) for fiscal year 2007, 
                                exceed by more than 5 percent 
                                the amount of the grant for the 
                                area that would have been made 
                                pursuant to this paragraph and 
                                paragraph (4) for fiscal year 
                                2006 (as such paragraphs were 
                                in effect for such fiscal year) 
                                if paragraph (2) (as so in 
                                effect) had been applied by 
                                substituting ``66\2/3\ 
                                percent'' for ``50 percent''; 
                                and
                                    (II) for each of the fiscal 
                                years 2008 through 2012, exceed 
                                by more than 5 percent the 
                                amount of the grant pursuant to 
                                this paragraph and paragraph 
                                (4) for the area for the 
                                preceding fiscal year.
                            (ii) Use of amounts involved.--For 
                        each of the fiscal years 2007 through 
                        2012, amounts available as a result of 
                        the limitation under clause (i) shall 
                        be made available by the Secretary as 
                        additional amounts for grants pursuant 
                        to subsection (b) for the fiscal year 
                        involved, subject to paragraph (4) and 
                        section 2610(d)(2).
            (4) Increases in grant.--
                    (A) In general.--For each eligible area 
                that received a grant pursuant to this 
                subsection for fiscal year 2009, the Secretary 
                shall, for each of the fiscal years 2010 
                through 2013, increase the amount of the grant 
                made pursuant to paragraph (3) for the area to 
                ensure that the amount of the grant for the 
                fiscal year involved is not less than the 
                following amount, as applicable to such fiscal 
                year:
                            (i) For fiscal year 2010, an amount 
                        equal to 95 percent of the sum of the 
                        amount of the grant made pursuant to 
                        paragraph (3) and this paragraph for 
                        fiscal year 2009.
                            (ii) For each of the fiscal years 
                        2011 and 2012, an amount equal to 100 
                        percent of the amount of the grant made 
                        pursuant to paragraph (3) and this 
                        paragraph for fiscal year 2010.
                            (iii) For fiscal year 2013, an 
                        amount equal to 92.5 percent of the 
                        amount of the grant made pursuant to 
                        paragraph (3) and this paragraph for 
                        fiscal year 2012.
                    (B) Source of funds for increase.--
                            (i) In general.--From the amounts 
                        available for carrying out the single 
                        program referred to in section 
                        2609(d)(2)(C) for a fiscal year 
                        (relating to supplemental grants), the 
                        Secretary shall make available such 
                        amounts as may be necessary to comply 
                        with subparagraph (A), subject to 
                        section 2610(d)(2).
                            (ii) Pro rata reduction.--If the 
                        amounts referred to in clause (i) for a 
                        fiscal year are insufficient to fully 
                        comply with subparagraph (A) for the 
                        year, the Secretary, in order to 
                        provide the additional funds necessary 
                        for such compliance, shall reduce on a 
                        pro rata basis the amount of each grant 
                        pursuant to this subsection for the 
                        fiscal year, other than grants for 
                        eligible areas for which increases 
                        under subparagraph (A) apply. A 
                        reduction under the preceding sentence 
                        may not be made in an amount that would 
                        result in the eligible area involved 
                        becoming eligible for such an increase.
                    (C) Limitation.--This paragraph may not be 
                construed as having any applicability after 
                fiscal year 2013.
    (b) Supplemental Grants.--
            (1) In general.--Subject to subsection (a)(4)(B)(i) 
        and section 2610(d), the Secretary shall disburse the 
        remainder of amounts not disbursed under section 
        2603(a)(2) for such fiscal year for the purpose of 
        making grants under section 2601(a) to eligible areas 
        whose application under section 2605(b)--
                    (A) contains a report concerning the 
                dissemination of emergency relief funds under 
                subsection (a) and the plan for utilization of 
                such funds;
                    (B) demonstrates the need in such area, on 
                an objective and quantified basis, for 
                supplemental financial assistance to combat the 
                HIV epidemic;
                    (C) demonstrates the existing commitment of 
                local resources of the area, both financial and 
                in-kind, to combating the HIV epidemic;
                    (D) demonstrates the ability of the area to 
                utilize such supplemental financial resources 
                in a manner that is immediately responsive and 
                cost effective;
                    (E) demonstrates that resources will be 
                allocated in accordance with the local 
                demographic incidence of AIDS including 
                appropriate allocations for services for 
                infants, children, youth, women, and families 
                with HIV/AIDS;
                    (F) demonstrates the inclusiveness of 
                affected communities and individuals with HIV/
                AIDS;
                    (G) demonstrates the manner in which the 
                proposed services are consistent with the local 
                needs assessment and the statewide coordinated 
                statement of need;
                    (H) demonstrates the ability of the 
                applicant to expend funds efficiently by not 
                having had, for the most recent grant year 
                under subsection (a) for which data is 
                available, more than 5 percent of grant funds 
                under such subsection canceled, offset under 
                subsection (c)(4), or covered by any waivers 
                under subsection (c)(3); and
                    (I) demonstrates success in identifying 
                individuals with HIV/AIDS as described in 
                clauses (i) through (iii) of paragraph (2)(A).
            (2) Amount of grant.--
                    (A) In general.--The amount of each grant 
                made for purposes of this subsection shall be 
                determined by the Secretary based on a 
                weighting of factors under paragraph (1), with 
                demonstrated need under subparagraph (B) of 
                such paragraph counting one-third, and 
                demonstrated success in identifying individuals 
                with HIV/AIDS who do not know their HIV status 
                and making them aware of such status counting 
                one-third. In making such determination, the 
                Secretary shall consider--
                            (i) the number of individuals who 
                        have been tested for HIV/AIDS;
                            (ii) of those individuals described 
                        in clause (i), the number of 
                        individuals who tested for HIV/AIDS who 
                        are made aware of their status, 
                        including the number who test positive; 
                        and
                            (iii) of those individuals 
                        described in clause (ii), the number 
                        who have been referred to appropriate 
                        treatment and care.
                    (B) Demonstrated need.--The factors 
                considered by the Secretary in determining 
                whether an eligible area has a demonstrated 
                need for purposes of paragraph (1)(B) may 
                include any or all of the following:
                            (i) The unmet need for such 
                        services, as determined under section 
                        2602(b)(4) or other community input 
                        process as defined under section 
                        2609(d)(1)(A).
                            (ii) An increasing need for HIV/
                        AIDS-related services, including 
                        relative rates of increase in the 
                        number of cases of HIV/AIDS.
                            (iii) The relative rates of 
                        increase in the number of cases of HIV/
                        AIDS within new or emerging 
                        subpopulations.
                            (iv) The current prevalence of HIV/
                        AIDS.
                            (v) Relevant factors related to the 
                        cost and complexity of delivering 
                        health care to individuals with HIV/
                        AIDS in the eligible area.
                            (vi) The impact of co-morbid 
                        factors, including co-occurring 
                        conditions, determined relevant by the 
                        Secretary.
                            (vii) The prevalence of 
                        homelessness.
                            (viii) The prevalence of 
                        individuals described under section 
                        2602(b)(2)(M).
                            (ix) The relevant factors that 
                        limit access to health care, including 
                        geographic variation, adequacy of 
                        health insurance coverage, and language 
                        barriers.
                            (x) The impact of a decline in the 
                        amount received pursuant to subsection 
                        (a) on services available to all 
                        individuals with HIV/AIDS identified 
                        and eligible under this title.
                    (C) Priority in making grants.--The 
                Secretary shall provide funds under this 
                subsection to an eligible area to address the 
                decline or disruption of all EMA-provided 
                services related to the decline in the amounts 
                received pursuant to subsection (a) consistent 
                with the grant award for the eligible area for 
                fiscal year 2006, to the extent that the factor 
                under subparagraph (B)(x) (relating to a 
                decline in funding) applies to the eligible 
                area.
                    (D) Increased adjustment for certain areas 
                previously using code-based reporting.--For 
                purposes of this subsection for each of fiscal 
                years 2010 through 2012, the Secretary shall 
                deem the applicable number of living cases of 
                HIV/AIDS in an area that were reported to and 
                confirmed by the Centers for Disease Control 
                and Prevention to be 3 percent higher than the 
                actual number if the conditions described in 
                items (aa) through (cc) of subsection 
                (a)(3)(C)(vi)(III) are all satisfied.
            (3) Remainder of amounts.--In determining the 
        amount of funds to be obligated under paragraph (1), 
        the Secretary shall include amounts that are not paid 
        to the eligible areas under expedited procedures under 
        section 2603(a)(2) as a result of--
                    (A) the failure of any eligible area to 
                submit an application under section 2605(c); or
                    (B) any eligible area informing the 
                Secretary that such eligible area does not 
                intend to expend the full amount of its grant 
                under such section.
            (4) Failure to submit.--
                    (A) In general.--The failure of an eligible 
                area to submit an application for an expedited 
                grant under section 2603(a)(2) shall not result 
                in such area being ineligible for a grant under 
                this subsection.
                    (B) Application.--The application of an 
                eligible area submitted under section 2605(b) 
                shall contain the assurances required under 
                subsection (a) of such section if such eligible 
                area fails to submit an application for an 
                expedited grant under section 2603(a)(2).
    (c) Timeframe for Obligation and Expenditure of Grant 
Funds.--
            (1) Obligation by end of grant year.--Effective for 
        fiscal year 2007 and subsequent fiscal years, funds 
        from a grant award made pursuant to subsection (a) or 
        (b) for a fiscal year are available for obligation by 
        the eligible area involved through the end of the one-
        year period beginning on the date in such fiscal year 
        on which funds from the award first become available to 
        the area (referred to in this subsection as the ``grant 
        year for the award''), except as provided in paragraph 
        (3)(A).
            (2) Supplemental grants; cancellation of 
        unobligated balance of grant award.--Effective for 
        fiscal year 2007 and subsequent fiscal years, if a 
        grant award made pursuant to subsection (b) for an 
        eligible area for a fiscal year has an unobligated 
        balance as of the end of the grant year for the award--
                    (A) the Secretary shall cancel that 
                unobligated balance of the award, and shall 
                require the eligible area to return any amounts 
                from such balance that have been disbursed to 
                the area; and
                    (B) the funds involved shall be made 
                available by the Secretary as additional 
                amounts for grants pursuant to subsection (b) 
                for the first fiscal year beginning after the 
                fiscal year in which the Secretary obtains the 
                information necessary for determining that the 
                balance is required under subparagraph (A) to 
                be canceled, except that the availability of 
                the funds for such grants is subject to 
                subsection (a)(4) and section 2610(d)(2) as 
                applied for such year.
            (3) Formula grants; cancellation of unobligated 
        balance of grant award; waiver permitting carryover.--
                    (A) In general.--Effective for fiscal year 
                2007 and subsequent fiscal years, if a grant 
                award made pursuant to subsection (a) for an 
                eligible area for a fiscal year has an 
                unobligated balance as of the end of the grant 
                year for the award, the Secretary shall cancel 
                that unobligated balance of the award, and 
                shall require the eligible area to return any 
                amounts from such balance that have been 
                disbursed to the area, unless--
                            (i) before the end of the grant 
                        year, the chief elected official of the 
                        area submits to the Secretary a written 
                        application for a waiver of the 
                        cancellation, which application 
                        includes a description of the purposes 
                        for which the area intends to expend 
                        the funds involved; and
                            (ii) the Secretary approves the 
                        waiver.
                    (B) Expenditure by end of carryover year.--
                With respect to a waiver under subparagraph (A) 
                that is approved for a balance that is 
                unobligated as of the end of a grant year for 
                an award:
                            (i) The unobligated funds are 
                        available for expenditure by the 
                        eligible area involved for the one-year 
                        period beginning upon the expiration of 
                        the grant year (referred to in this 
                        subsection as the ``carryover year'').
                            (ii) If the funds are not expended 
                        by the end of the carryover year, the 
                        Secretary shall cancel that unexpended 
                        balance of the award, and shall require 
                        the eligible area to return any amounts 
                        from such balance that have been 
                        disbursed to the area.
                    (C) Use of cancelled balances.--In the case 
                of any balance of a grant award that is 
                cancelled under subparagraph (A) or (B)(ii), 
                the grant funds involved shall be made 
                available by the Secretary as additional 
                amounts for grants pursuant to subsection (b) 
                for the first fiscal year beginning after the 
                fiscal year in which the Secretary obtains the 
                information necessary for determining that the 
                balance is required under such subparagraph to 
                be canceled, except that the availability of 
                the funds for such grants is subject to 
                subsection (a)(4) and section 2610(d)(2) as 
                applied for such year.
                    (D) Corresponding reduction in future 
                grant.--
                            (i) In general.--In the case of an 
                        eligible area for which a balance from 
                        a grant award under subsection (a) is 
                        unobligated as of the end of the grant 
                        year for the award--
                                    (I) the Secretary shall 
                                reduce, by the same amount as 
                                such unobligated balance (less 
                                any amount of such balance that 
                                is the subject of a waiver of 
                                cancellation under subparagraph 
                                (A)), the amount of the grant 
                                under such subsection for the 
                                first fiscal year beginning 
                                after the fiscal year in which 
                                the Secretary obtains the 
                                information necessary for 
                                determining that such balance 
                                was unobligated as of the end 
                                of the grant year (which 
                                requirement for a reduction 
                                applies without regard to 
                                whether a waiver under 
                                subparagraph (A) has been 
                                approved with respect to such 
                                balance); and
                                    (II) the grant funds 
                                involved in such reduction 
                                shall be made available by the 
                                Secretary as additional funds 
                                for grants pursuant to 
                                subsection (b) for such first 
                                fiscal year, subject to 
                                subsection (a)(4) and section 
                                2610(d)(2);
                        except that this clause does not apply 
                        to the eligible area if the amount of 
                        the unobligated balance was 5 percent 
                        or less.
                            (ii) Relation to increases in 
                        grant.--A reduction under clause (i) 
                        for an eligible area for a fiscal year 
                        may not be taken into account in 
                        applying subsection (a)(4) with respect 
                        to the area for the subsequent fiscal 
                        year.
            (4) Authority regarding administration of 
        provisions.--In administering paragraphs (2) and (3) 
        with respect to the unobligated balance of an eligible 
        area, the Secretary may elect to reduce the amount of 
        future grants to the area under subsection (a) or (b), 
        as applicable, by the amount of any such unobligated 
        balance in lieu of cancelling such amount as provided 
        for in paragraph (2) or (3)(A). In such case, the 
        Secretary may permit the area to use such unobligated 
        balance for purposes of any such future grant. An 
        amount equal to such reduction shall be available for 
        use as additional amounts for grants pursuant to 
        subsection (b), subject to subsection (a)(4) and 
        section 2610(d)(2). Nothing in this paragraph shall be 
        construed to affect the authority of the Secretary 
        under paragraphs (2) and (3), including the authority 
        to grant waivers under paragraph (3)(A). The reduction 
        in future grants authorized under this paragraph shall 
        be notwithstanding the penalty required under paragraph 
        (3)(D) with respect to unobligated funds.
    (d) Compliance With Priorities of HIV Planning Council.--
Notwithstanding any other provision of this subpart, the 
Secretary, in carrying out section 2601(a), may not make any 
grant under subsection (a) or (b) to an eligible area unless 
the application submitted by such area under section 2605 for 
the grant involved demonstrates that the grants made under 
subsections (a) and (b) to the area for the preceding fiscal 
year (if any) were expended in accordance with the priorities 
applicable to such year that were established, pursuant to 
section 2602(b)(4)(C), by the planning council serving the 
area.
    (e) Report on the Awarding of Supplemental Funds.--Not 
later than 45 days after the awarding of supplemental funds 
under this section, the Secretary shall submit to Congress a 
report concerning such funds. Such report shall include 
information detailing--
            (1) the total amount of supplemental funds 
        available under this section for the year involved;
            (2) the amount of supplemental funds used in 
        accordance with the hold harmless provisions of 
        subsection (a)(4);
            (3) the amount of supplemental funds disbursed 
        pursuant to subsection (b)(2)(C);
            (4) the disbursement of the remainder of the 
        supplemental funds after taking into account the uses 
        described in paragraphs (2) and (3); and
            (5) the rationale used for the amount of funds 
        disbursed as described under paragraphs (2), (3), and 
        (4).

SEC. 2604. [300FF-14] USE OF AMOUNTS.

    (a) Requirements.--The Secretary may not make a grant under 
section 2601(a) to the chief elected official of an eligible 
area unless such political subdivision agrees that--
            (1) subject to paragraph (2), the allocation of 
        funds and services within the eligible area will be 
        made in accordance with the priorities established, 
        pursuant to section 2602(b)(4)(C), by the HIV health 
        services planning council that serves such eligible 
        area;
            (2) funds provided under section 2601 will be 
        expended only for--
                    (A) core medical services described in 
                subsection (c);
                    (B) support services described in 
                subsection (d); and
                    (C) administrative expenses described in 
                subsection (h); and
            (3) the use of such funds will comply with the 
        requirements of this section.
    (b) Direct Financial Assistance to Appropriate Entities.--
            (1) In general.--The chief elected official of an 
        eligible area shall use amounts from a grant under 
        section 2601 to provide direct financial assistance to 
        entities described in paragraph (2) for the purpose of 
        providing core medical services and support services.
            (2) Appropriate entities.--Direct financial 
        assistance may be provided under paragraph (1) to 
        public or nonprofit private entities, or private for-
        profit entities if such entities are the only available 
        provider of quality HIV care in the area.
    (c) Required Funding for Core Medical Services.--
            (1) In general.--With respect to a grant under 
        section 2601 for an eligible area for a grant year, the 
        chief elected official of the area shall, of the 
        portion of the grant remaining after reserving amounts 
        for purposes of paragraphs (1) and (5)(B)(i) of 
        subsection (h), use not less than 75 percent to provide 
        core medical services that are needed in the eligible 
        area for individuals with HIV/AIDS who are identified 
        and eligible under this title (including services 
        regarding the co-occurring conditions of the 
        individuals).
            (2) Waiver.--
                    (A) In general.--The Secretary shall waive 
                the application of paragraph (1) with respect 
                to a chief elected official for a grant year if 
                the Secretary determines that, within the 
                eligible area involved--
                            (i) there are no waiting lists for 
                        AIDS Drug Assistance Program services 
                        under section 2616; and
                            (ii) core medical services are 
                        available to all individuals with HIV/
                        AIDS identified and eligible under this 
                        title.
                    (B) Notification of waiver status.--When 
                informing the chief elected official of an 
                eligible area that a grant under section 2601 
                is being made for the area for a grant year, 
                the Secretary shall inform the official whether 
                a waiver under subparagraph (A) is in effect 
                for such year.
            (3) Core medical services.--For purposes of this 
        subsection, the term ``core medical services'', with 
        respect to an individual with HIV/AIDS (including the 
        co-occurring conditions of the individual), means the 
        following services:
                    (A) Outpatient and ambulatory health 
                services.
                    (B) AIDS Drug Assistance Program treatments 
                in accordance with section 2616.
                    (C) AIDS pharmaceutical assistance.
                    (D) Oral health care.
                    (E) Early intervention services described 
                in subsection (e).
                    (F) Health insurance premium and cost 
                sharing assistance for low-income individuals 
                in accordance with section 2615.
                    (G) Home health care.
                    (H) Medical nutrition therapy.
                    (I) Hospice services.
                    (J) Home and community-based health 
                services as defined under section 2614(c).
                    (K) Mental health services.
                    (L) Substance abuse outpatient care.
                    (M) Medical case management, including 
                treatment adherence services.
    (d) Support Services.--
            (1) In general.--For purposes of this section, the 
        term ``support services'' means services, subject to 
        the approval of the Secretary, that are needed for 
        individuals with HIV/AIDS to achieve their medical 
        outcomes (such as respite care for persons caring for 
        individuals with HIV/AIDS, outreach services, medical 
        transportation, linguistic services, and referrals for 
        health care and support services).
            (2) Medical outcomes.--In this subsection, the term 
        ``medical outcomes'' means those outcomes affecting the 
        HIV-related clinical status of an individual with HIV/
        AIDS.
    (e) Early Intervention Services.--
            (1) In general.--For purposes of this section, the 
        term ``early intervention services'' means HIV/AIDS 
        early intervention services described in section 
        2651(e), with follow-up referral provided for the 
        purpose of facilitating the access of individuals 
        receiving the services to HIV-related health services. 
        The entities through which such services may be 
        provided under the grant include public health 
        departments, emergency rooms, substance abuse and 
        mental health treatment programs, detoxification 
        centers, detention facilities, clinics regarding 
        sexually transmitted diseases, homeless shelters, HIV/
        AIDS counseling and testing sites, health care points 
        of entry specified by eligible areas, federally 
        qualified health centers, and entities described in 
        section 2652(a) that constitute a point of access to 
        services by maintaining referral relationships.
            (2) Conditions.--With respect to an entity that 
        proposes to provide early intervention services under 
        paragraph (1), such paragraph shall apply only if the 
        entity demonstrates to the satisfaction of the chief 
        elected official for the eligible area involved that--
                    (A) Federal, State, or local funds are 
                otherwise inadequate for the early intervention 
                services the entity proposes to provide; and
                    (B) the entity will expend funds pursuant 
                to such paragraph to supplement and not 
                supplant other funds available to the entity 
                for the provision of early intervention 
                services for the fiscal year involved.
    (f) Priority for Women, Infants, Children, and Youth.--
            (1) In general.--For the purpose of providing 
        health and support services to infants, children, 
        youth, and women with HIV/AIDS, including treatment 
        measures to prevent the perinatal transmission of HIV, 
        the chief elected official of an eligible area, in 
        accordance with the established priorities of the 
        planning council, shall for each of such populations in 
        the eligible area use, from the grants made for the 
        area under section 2601(a) for a fiscal year, not less 
        than the percentage constituted by the ratio of the 
        population involved (infants, children, youth, or women 
        in such area) with HIV/AIDS to the general population 
        in such area of individuals with HIV/AIDS.
            (2) Waiver.--With respect to the population 
        involved, the Secretary may provide to the chief 
        elected official of an eligible area a waiver of the 
        requirement of paragraph (1) if such official 
        demonstrates to the satisfaction of the Secretary that 
        the population is receiving HIV-related health services 
        through the State medicaid program under title XIX of 
        the Social Security Act, the State children's health 
        insurance program under title XXI of such Act, or other 
        Federal or State programs.
    (g) Requirement of Status as Medicaid Provider.--
            (1) Provision of service.--Subject to paragraph 
        (2), the Secretary may not make a grant under section 
        2601(a) for the provision of services under this 
        section in a State unless, in the case of any such 
        service that is available pursuant to the State plan 
        approved under title XIX of the Social Security Act for 
        the State--
                    (A) the political subdivision involved will 
                provide the service directly, and the political 
                subdivision has entered into a participation 
                agreement under the State plan and is qualified 
                to receive payments under such plan; or
                    (B) the political subdivision will enter 
                into an agreement with a public or nonprofit 
                private entity under which the entity will 
                provide the service, and the entity has entered 
                into such a participation agreement and is 
                qualified to receive such payments.
            (2) Waiver.--
                    (A) In general.--In the case of an entity 
                making an agreement pursuant to paragraph 
                (1)(B) regarding the provision of services, the 
                requirement established in such paragraph shall 
                be waived by the HIV health services planning 
                council for the eligible area if the entity 
                does not, in providing health care services, 
                impose a charge or accept reimbursement 
                available from any third-party payor, including 
                reimbursement under any insurance policy or 
                under any Federal or State health benefits 
                program.
                    (B) Determination.--A determination by the 
                HIV health services planning council of whether 
                an entity referred to in subparagraph (A) meets 
                the criteria for a waiver under such 
                subparagraph shall be made without regard to 
                whether the entity accepts voluntary donations 
                for the purpose of providing services to the 
                public.
    (h) Administration.--
            (1) Limitation.--The chief elected official of an 
        eligible area shall not use in excess of 10 percent of 
        amounts received under a grant under this subpart for 
        administrative expenses.
            (2) Allocations by chief elected official.--In the 
        case of entities and subcontractors to which the chief 
        elected official of an eligible area allocates amounts 
        received by the official under a grant under this 
        subpart, the official shall ensure that, of the 
        aggregate amount so allocated, the total of the 
        expenditures by such entities for administrative 
        expenses does not exceed 10 percent (without regard to 
        whether particular entities expend more than 10 percent 
        for such expenses).
            (3) Administrative activities.--For purposes of 
        paragraph (1), amounts may be used for administrative 
        activities that include--
                    (A) routine grant administration and 
                monitoring activities, including the 
                development of applications for part A funds, 
                the receipt and disbursal of program funds, the 
                development and establishment of reimbursement 
                and accounting systems, the development of a 
                clinical quality management program as 
                described in paragraph (5), the preparation of 
                routine programmatic and financial reports, and 
                compliance with grant conditions and audit 
                requirements; and
                    (B) all activities associated with the 
                grantee's contract award procedures, including 
                the activities carried out by the HIV health 
                services planning council as established under 
                section 2602(b), the development of requests 
                for proposals, contract proposal review 
                activities, negotiation and awarding of 
                contracts, monitoring of contracts through 
                telephone consultation, written documentation 
                or onsite visits, reporting on contracts, and 
                funding reallocation activities.
            (4) Subcontractor administrative activities.--For 
        the purposes of this subsection, subcontractor 
        administrative activities include--
                    (A) usual and recognized overhead 
                activities, including established indirect 
                rates for agencies;
                    (B) management oversight of specific 
                programs funded under this title; and
                    (C) other types of program support such as 
                quality assurance, quality control, and related 
                activities.
            (5) Clinical quality management.--
                    (A) Requirement.--The chief elected 
                official of an eligible area that receives a 
                grant under this subpart shall provide for the 
                establishment of a clinical quality management 
                program to assess the extent to which HIV 
                health services provided to patients under the 
                grant are consistent with the most recent 
                Public Health Service guidelines for the 
                treatment of HIV/AIDS and related opportunistic 
                infection, and as applicable, to develop 
                strategies for ensuring that such services are 
                consistent with the guidelines for improvement 
                in the access to and quality of HIV health 
                services.
                    (B) Use of funds.--
                            (i) In general.--From amounts 
                        received under a grant awarded under 
                        this subpart for a fiscal year, the 
                        chief elected official of an eligible 
                        area may use for activities associated 
                        with the clinical quality management 
                        program required in subparagraph (A) 
                        not to exceed the lesser of--
                                    (I) 5 percent of amounts 
                                received under the grant; or
                                    (II) $3,000,000.
                            (ii) Relation to limitation on 
                        administrative expenses.--The costs of 
                        a clinical quality management program 
                        under subparagraph (A) may not be 
                        considered administrative expenses for 
                        purposes of the limitation established 
                        in paragraph (1).
    (i) Construction.--A chief elected official may not use 
amounts received under a grant awarded under this subpart to 
purchase or improve land, or to purchase, construct, or 
permanently improve (other than minor remodeling) any building 
or other facility, or to make cash payments to intended 
recipients of services.

SEC. 2605. [300FF-15] APPLICATION.

    (a) In General.--To be eligible to receive a grant under 
section 2601, an eligible area shall prepare and submit to the 
Secretary an application, in accordance with subsection (c) 
regarding a single application and grant award, at such time, 
in such form, and containing such information as the Secretary 
shall require, including assurances adequate to ensure--
            (1)(A) that funds received under a grant awarded 
        under this subpart will be utilized to supplement not 
        supplant State funds made available in the year for 
        which the grant is awarded to provide HIV-related 
        services as described in section 2604(b)(1);
            (B) that the political subdivisions within the 
        eligible area will maintain the level of expenditures 
        by such political subdivisions for HIV-related services 
        as described in section 2604(b)(1) at a level that is 
        equal to the level of such expenditures by such 
        political subdivisions for the preceding fiscal year; 
        and
            (C) that political subdivisions within the eligible 
        area will not use funds received under a grant awarded 
        under this subpart in maintaining the level of 
        expenditures for HIV-related services as required in 
        subparagraph (B);
            (2) that the eligible area has an HIV health 
        services planning council and has entered into 
        intergovernmental agreements pursuant to section 2602, 
        and has developed or will develop the comprehensive 
        plan in accordance with section 2602(b)(3)(B);
            (3) that entities within the eligible area that 
        receive funds under a grant under this subpart will 
        maintain appropriate relationships with entities in the 
        eligible area served that constitute key points of 
        access to the health care system for individuals with 
        HIV/AIDS (including emergency rooms, substance abuse 
        treatment programs, detoxification centers, adult and 
        juvenile detention facilities, sexually transmitted 
        disease clinics, HIV counseling and testing sites, 
        mental health programs, and homeless shelters), and 
        other entities under section 2604(b)(3) and 2652(a), 
        for the purpose of facilitating early intervention for 
        individuals newly diagnosed with HIV/AIDS and 
        individuals knowledgeable of their HIV status but not 
        in care;
            (4) that the chief elected official of the eligible 
        area will satisfy all requirements under section 
        2604(c);
            (5) that entities within the eligible area that 
        will receive funds under a grant provided under section 
        2601(a) shall participate in an established HIV 
        community-based continuum of care if such continuum 
        exists within the eligible area;
            (6) that funds received under a grant awarded under 
        this subpart will not be utilized to make payments for 
        any item or service to the extent that payment has been 
        made, or can reasonably be expected to be made, with 
        respect to that item or service--
                    (A) under any State compensation program, 
                under an insurance policy, or under any Federal 
                or State health benefits program (except for a 
                program administered by or providing the 
                services of the Indian Health Service); or
                    (B) by an entity that provides health 
                services on a prepaid basis;
            (7) to the maximum extent practicable, that--
                    (A) HIV health care and support services 
                provided with assistance made available under 
                this subpart will be provided without regard--
                            (i) to the ability of the 
                        individual to pay for such services; 
                        and
                            (ii) to the current or past health 
                        condition of the individual to be 
                        served;
                    (B) such services will be provided in a 
                setting that is accessible to low-income 
                individuals with HIV-disease; and
                    (C) a program of outreach will be provided 
                to low-income individuals with HIV-disease to 
                inform such individuals of such services;
            (8) that the applicant has participated, or will 
        agree to participate, in the statewide coordinated 
        statement of need process where it has been initiated 
        by the State public health agency responsible for 
        administering grants under part B, and ensure that the 
        services provided under the comprehensive plan are 
        consistent with the statewide coordinated statement of 
        need;
            (9) that the eligible area has procedures in place 
        to ensure that services provided with funds received 
        under this subpart meet the criteria specified in 
        section 2604(b)(1); and
            (10) that the chief elected official will submit to 
        the lead State agency under section 2617(b)(4), audits, 
        consistent with Office of Management and Budget 
        circular A133, regarding funds expended in accordance 
        with this subpart every 2 years and shall include 
        necessary client-based data to compile unmet need 
        calculations and Statewide coordinated statements of 
        need process.
    (b) Application.--An eligible area that desires to receive 
a grant under section 2603(b) shall prepare and submit to the 
Secretary an application, in accordance with subsection (c) 
regarding a single application and grant award, at such time, 
in such form, and containing such information as the Secretary 
shall require, including the information required under such 
subsection and information concerning--
            (1) the number of individuals to be served within 
        the eligible area with assistance provided under the 
        grant, including the identification of individuals with 
        HIV/AIDS as described in clauses (i) through (iii) of 
        section 2603(b)(2)(A);
            (2) demographic data on the population of such 
        individuals;
            (3) the average cost of providing each category of 
        HIV-related health services and the extent to which 
        such cost is paid by third-party payors;
            (4) the aggregate amounts expended for each such 
        category of services;
            (5) the manner in which the expected expenditures 
        are related to the planning process for States that 
        receive funding under part B (including the planning 
        process described in section 2617(b)); and
            (6) the expected expenditures and how those 
        expenditures will improve overall client outcomes, as 
        described under the State plan under section 2617(b), 
        and through additional outcomes measures as identified 
        by the HIV health services planning council under 
        section 2602(b).
    (c) Single Application and Grant Award.--
            (1) Application.--The Secretary may phase in the 
        use of a single application that meets the requirements 
        of subsections (a) and (b) of section 2603 with respect 
        to an eligible area that desires to receive grants 
        under section 2603 for a fiscal year.
            (2) Grant award.--The Secretary may phase in the 
        awarding of a single grant to an eligible area that 
        submits an approved application under paragraph (1) for 
        a fiscal year.
    (d) Date Certain for Submission.--
            (1) Requirement.--Except as provided in paragraph 
        (2), to be eligible to receive a grant under section 
        2601(a) for a fiscal year, an application under 
        subsection (a) shall be submitted not later than 45 
        days after the date on which appropriations are made 
        under section 2677 for the fiscal year.
            (2) Exception.--The Secretary may extend the time 
        for the submission of an application under paragraph 
        (1) for a period of not to exceed 60 days if the 
        Secretary determines that the eligible area has made a 
        good faith effort to comply with the requirement of 
        such paragraph but has otherwise been unable to submit 
        its application.
            (3) Distribution by Secretary.--Not later than 45 
        days after receiving an application that meets the 
        requirements of subsection (a) from an eligible area, 
        the Secretary shall distribute to such eligible area 
        the amounts awarded under the grant for which the 
        application was submitted.
            (4) Redistribution.--Any amounts appropriated in 
        any fiscal year under this subpart and not obligated to 
        an eligible entity as a result of the failure of such 
        entity to submit an application shall be redistributed 
        by the Secretary to other eligible entities in 
        proportion to the original grants made to such eligible 
        areas under section 2601(a).
    (e) Requirements Regarding Imposition of Charges for 
Services.--
            (1) In general.--The Secretary may not make a grant 
        under section 2601 to an eligible area unless the 
        eligible area provides assurances that in the provision 
        of services with assistance provided under the grant--
                    (A) in the case of individuals with an 
                income less than or equal to 100 percent of the 
                official poverty line, the provider will not 
                impose charges on any such individual for the 
                provision of services under the grant;
                    (B) in the case of individuals with an 
                income greater than 100 percent of the official 
                poverty line, the provider--
                            (i) will impose a charge on each 
                        such individual for the provision of 
                        such services; and
                            (ii) will impose the charge 
                        according to a schedule of charges that 
                        is made available to the public;
                    (C) in the case of individuals with an 
                income greater than 100 percent of the official 
                poverty line and not exceeding 200 percent of 
                such poverty line, the provider will not, for 
                any calendar year, impose charges in an amount 
                exceeding 5 percent of the annual gross income 
                of the individual involved;
                    (D) in the case of individuals with an 
                income greater than 200 percent of the official 
                poverty line and not exceeding 300 percent of 
                such poverty line, the provider will not, for 
                any calendar year, impose charges in an amount 
                exceeding 7 percent of the annual gross income 
                of the individual involved; and
                    (E) in the case of individuals with an 
                income greater than 300 percent of the official 
                poverty line, the provider will not, for any 
                calendar year, impose charges in an amount 
                exceeding 10 percent of the annual gross income 
                of the individual involved.
            (2) Assessment of charge.--With respect to 
        compliance with the assurance made under paragraph (1), 
        a grantee or entity receiving assistance under this 
        subpart may, in the case of individuals subject to a 
        charge for purposes of such paragraph--
                    (A) assess the amount of the charge in the 
                discretion of the grantee, including imposing 
                only a nominal charge for the provision of 
                services, subject to the provisions of such 
                paragraph regarding public schedules and 
                regarding limitations on the maximum amount of 
                charges; and
                    (B) take into consideration the medical 
                expenses of individuals in assessing the amount 
                of the charge, subject to such provisions.
            (3) Applicability of limitation on amount of 
        charge.--The Secretary may not make a grant under 
        section 2601 to an eligible area unless the eligible 
        area agrees that the limitations established in 
        subparagraphs (C), (D) and (E) of paragraph (1) 
        regarding the imposition of charges for services 
        applies to the annual aggregate of charges imposed for 
        such services, without regard to whether they are 
        characterized as enrollment fees, premiums, 
        deductibles, cost sharing, copayments, coinsurance, or 
        other charges.
            (4) Waiver regarding secondary agreements.--The 
        requirements established in paragraphs (1) through (3) 
        shall be waived in accordance with section 2604(d)(2).

SEC. 2606. [300FF-16] TECHNICAL ASSISTANCE.

    The Administrator of the Health Resources and Services 
Administration shall, beginning on the date of enactment of 
this title, provide technical assistance, including assistance 
from other grantees, contractors or subcontractors under this 
title to assist newly eligible metropolitan areas in the 
establishment of HIV health services planning councils and, to 
assist entities in complying with the requirements of this 
subpart in order to make such entities eligible to receive a 
grant under this subpart. The Administrator may make planning 
grants available to metropolitan areas, in an amount not to 
exceed $75,000 for any metropolitan area, projected to be 
eligible for funding under section 2601 in the following fiscal 
year. Such grant amounts shall be deducted from the first year 
formula award to eligible areas accepting such grants. Not to 
exceed 1 percent of the amount appropriated for a fiscal year 
under section 2677 for grants under part A may be used to carry 
out this section.

SEC. 2607. [300FF-17] DEFINITIONS.

    For purposes of this subpart:
            (1) Eligible area.--The term ``eligible area'' 
        means a metropolitan area meeting the requirements of 
        section 2601 that are applicable to the area.
            (2) Metropolitan area.--The term ``metropolitan 
        area'' means an area that is referred to in the HIV/
        AIDS Surveillance Report of the Centers for Disease 
        Control and Prevention as a metropolitan area, and that 
        has a population of 50,000 or more individuals.

                    Subpart II--Transitional Grants

SEC. 2609. [300FF-19] ESTABLISHMENT OF PROGRAM.

    (a) In General.--The Secretary, acting through the 
Administrator of the Health Resources and Services 
Administration, shall make grants for the purpose of providing 
services described in section 2604 in transitional areas, 
subject to the same provisions regarding the allocation of 
grant funds as apply under subsection (c) of such section.
    (b) Transitional Areas.--For purposes of this section, the 
term ``transitional area'' means, subject to subsection (c), a 
metropolitan area for which there has been reported to and 
confirmed by the Director of the Centers for Disease Control 
and Prevention a cumulative total of at least 1,000, but fewer 
than 2,000, cases of AIDS during the most recent period of 5 
calendar years for which such data are available.
    (c) Certain Eligibility Rules.--
            (1) Fiscal year 2011.--With respect to grants under 
        subsection (a) for fiscal year 2011, a metropolitan 
        area that received funding under subpart I for fiscal 
        year 2010 but does not for fiscal year 2011 qualify 
        under such subpart as an eligible area and does not 
        qualify under subsection (b) as a transitional area 
        shall, notwithstanding subsection (b), be considered a 
        transitional area.
            (2) Continued status as transitional area.--
                    (A) In general.--Notwithstanding subsection 
                (b), a metropolitan area that is a transitional 
                area for a fiscal year continues, except as 
                provided in subparagraph (B), to be a 
                transitional area until the metropolitan area 
                fails, for three consecutive fiscal years--
                            (i) to qualify under such 
                        subsection as a transitional area; and
                            (ii) subject to subparagraphs (B) 
                        and (C), to have a cumulative total of 
                        1,500 or more living cases of AIDS 
                        (reported to and confirmed by the 
                        Director of the Centers for Disease 
                        Control and Prevention) as of December 
                        31 of the most recent calendar year for 
                        which such data is available.
                    (B) Permitting margin of error applicable 
                to certain metropolitan areas.--In applying 
                subparagraph (A)(ii) for a fiscal year after 
                fiscal year 2008, in the case of a metropolitan 
                area that has a cumulative total of at least 
                1,400 (and fewer than 1,500) living cases of 
                AIDS as of December 31 of the most recent 
                calendar year for which such data is available, 
                such area shall be treated as having met the 
                criteria of such subparagraph if not more than 
                5 percent of the total from grants awarded to 
                such area under this part is unobligated as of 
                the end of the most recent fiscal year for 
                which such data is available.
                    (C) Exception regarding status as eligible 
                area.--Subparagraphs (A) and (B) do not apply 
                for a fiscal year if the metropolitan area 
                involved qualifies under subpart I as an 
                eligible area.
    (d) Application of Certain Provisions of Subpart I.--
            (1) Administration; planning council.--
                    (A) In general.--The provisions of section 
                2602 apply with respect to a grant under 
                subsection (a) for a transitional area to the 
                same extent and in the same manner as such 
                provisions apply with respect to a grant under 
                subpart I for an eligible area, except that, 
                subject to subparagraph (B), the chief elected 
                official of the transitional area may elect not 
                to comply with the provisions of section 
                2602(b) if the official provides documentation 
                to the Secretary that details the process used 
                to obtain community input (particularly from 
                those with HIV) in the transitional area for 
                formulating the overall plan for priority 
                setting and allocating funds from the grant 
                under subsection (a).
                    (B) Exception.--For each of the fiscal 
                years 2007 through 2013, the exception 
                described in subparagraph (A) does not apply if 
                the transitional area involved received funding 
                under subpart I for fiscal year 2006.
            (2) Type and distribution of grants; timeframe for 
        obligation and expenditure of grant funds.--
                    (A) Formula grants; supplemental grants.--
                The provisions of section 2603 apply with 
                respect to grants under subsection (a) to the 
                same extent and in the same manner as such 
                provisions apply with respect to grants under 
                subpart I, subject to subparagraphs (B) and 
                (C).
                    (B) Formula grants; increase in grant.--For 
                purposes of subparagraph (A), section 
                2603(a)(4) does not apply.
                    (C) Supplemental grants; single program 
                with subpart i program.--With respect to 
                section 2603(b) as applied for purposes of 
                subparagraph (A):
                            (i) The Secretary shall combine 
                        amounts available pursuant to such 
                        subparagraph with amounts available for 
                        carrying out section 2603(b) and shall 
                        administer the two programs as a single 
                        program.
                            (ii) In the single program, the 
                        Secretary has discretion in allocating 
                        amounts between eligible areas under 
                        subpart I and transitional areas under 
                        this section, subject to the 
                        eligibility criteria that apply under 
                        such section, and subject to section 
                        2603(b)(2)(C) (relating to priority in 
                        making grants).
                            (iii) Pursuant to section 
                        2603(b)(1), amounts for the single 
                        program are subject to use under 
                        sections 2603(a)(4) and 2610(d)(1).
            (3) Application; technical assistance; 
        definitions.--The provisions of sections 2605, 2606, 
        and 2607 apply with respect to grants under subsection 
        (a) to the same extent and in the same manner as such 
        provisions apply with respect to grants under subpart 
        I.

                    Subpart III--General Provisions

SEC. 2610. [300FF-20] AUTHORIZATION OF APPROPRIATIONS.

    (a) In General.--For the purpose of carrying out this part, 
there are authorized to be appropriated $604,000,000 for fiscal 
year 2007, $626,300,000 for fiscal year 2008, $649,500,000 for 
fiscal year 2009, $681,975,000 for fiscal year 2010, 
$716,074,000 for fiscal year 2011, $751,877,000 for fiscal year 
2012, and $789,471,000 for fiscal year 2013. Amounts 
appropriated under the preceding sentence for a fiscal year are 
available for obligation by the Secretary until the end of the 
second succeeding fiscal year.
    (b) Reservation of Amounts.--
            (1) Fiscal year 2007.--Of the amount appropriated 
        under subsection (a) for fiscal year 2007, the 
        Secretary shall reserve--
                    (A) $458,310,000 for grants under subpart 
                I; and
                    (B) $145,690,000 for grants under section 
                2609.
            (2) Subsequent fiscal years.--Of the amount 
        appropriated under subsection (a) for fiscal year 2008 
        and each subsequent fiscal year--
                    (A) the Secretary shall reserve an amount 
                for grants under subpart I; and
                    (B) the Secretary shall reserve an amount 
                for grants under section 2609.
    (c) Transfer of Certain Amounts; Change in Status as 
Eligible Area or Transitional Area.--Notwithstanding subsection 
(b):
            (1) If a metropolitan area is an eligible area 
        under subpart I for a fiscal year, but for a subsequent 
        fiscal year ceases to be an eligible area by reason of 
        section 2601(b)--
                    (A)(i) the amount reserved under paragraph 
                (1)(A) or (2)(A) of subsection (b) of this 
                section for the first such subsequent year of 
                not being an eligible area is deemed to be 
                reduced by an amount equal to the amount of the 
                grant made pursuant to section 2603(a) for the 
                metropolitan area for the preceding fiscal 
                year; and
                    (ii)(I) if the metropolitan area qualifies 
                for such first subsequent fiscal year as a 
                transitional area under 2609, the amount 
                reserved under paragraph (1)(B) or (2)(B) of 
                subsection (b) for such fiscal year is deemed 
                to be increased by an amount equal to the 
                amount of the reduction under subparagraph (A) 
                for such year; or
                    (II) if the metropolitan area does not 
                qualify for such first subsequent fiscal year 
                as a transitional area under 2609, an amount 
                equal to the amount of such reduction is, 
                notwithstanding subsection (a), transferred and 
                made available for grants pursuant to section 
                2618(a)(1), in addition to amounts available 
                for such grants under section 2623; and
                    (B) if a transfer under subparagraph 
                (A)(ii)(II) is made with respect to the 
                metropolitan area for such first subsequent 
                fiscal year, then--
                            (i) the amount reserved under 
                        paragraph (1)(A) or (2)(A) of 
                        subsection (b) of this section for such 
                        year is deemed to be reduced by an 
                        additional $500,000; and
                            (ii) an amount equal to the amount 
                        of such additional reduction is, 
                        notwithstanding subsection (a), 
                        transferred and made available for 
                        grants pursuant to section 2618(a)(1), 
                        in addition to amounts available for 
                        such grants under section 2623.
            (2) If a metropolitan area is a transitional area 
        under section 2609 for a fiscal year, but for a 
        subsequent fiscal year ceases to be a transitional area 
        by reason of section 2609(c)(2) (and does not qualify 
        for such subsequent fiscal year as an eligible area 
        under subpart I)--
                    (A) the amount reserved under subsection 
                (b)(2)(B) of this section for the first such 
                subsequent fiscal year of not being a 
                transitional area is deemed to be reduced by an 
                amount equal to the total of--
                            (i) the amount of the grant that, 
                        pursuant to section 2603(a), was made 
                        under section 2609(d)(2)(A) for the 
                        metropolitan area for the preceding 
                        fiscal year; and
                            (ii) $500,000; and
                    (B)(i) subject to clause (ii), an amount 
                equal to the amount of the reduction under 
                subparagraph (A) for such year is, 
                notwithstanding subsection (a), transferred and 
                made available for grants pursuant to section 
                2618(a)(1), in addition to amounts available 
                for such grants under section 2623; and
                    (ii) for each of fiscal years 2010 through 
                2013, notwithstanding subsection (a)--
                            (I) there shall be transferred to 
                        the State containing the metropolitan 
                        area, for purposes described in section 
                        2612(a), an amount (which shall not be 
                        taken into account in applying section 
                        2618(a)(2)(H)) equal to--
                                    (aa) for the first fiscal 
                                year of the metropolitan area 
                                not being a transitional area, 
                                75 percent of the amount 
                                described in subparagraph 
                                (A)(i) for such area;
                                    (bb) for the second fiscal 
                                year of the metropolitan area 
                                not being a transitional area, 
                                50 percent of such amount; and
                                    (cc) for the third fiscal 
                                year of the metropolitan area 
                                not being a transitional area, 
                                25 percent of such amount; and
                            (II) there shall be transferred and 
                        made available for grants pursuant to 
                        section 2618(a)(1) for the fiscal year, 
                        in addition to amounts available for 
                        such grants under section 2623, an 
                        amount equal to the total amount of the 
                        reduction for such fiscal year under 
                        subparagraph (A), less the amount 
                        transferred for such fiscal year under 
                        subclause (I).
            (3) If a metropolitan area is a transitional area 
        under section 2609 for a fiscal year, but for a 
        subsequent fiscal year qualifies as an eligible area 
        under subpart I--
                    (A) the amount reserved under subsection 
                (b)(2)(B) of this section for the first such 
                subsequent fiscal year of becoming an eligible 
                area is deemed to be reduced by an amount equal 
                to the amount of the grant that, pursuant to 
                section 2603(a), was made under section 
                2609(d)(2)(A) for the metropolitan area for the 
                preceding fiscal year; and
                    (B) the amount reserved under subsection 
                (b)(2)(A) for such fiscal year is deemed to be 
                increased by an amount equal to the amount of 
                the reduction under subparagraph (A) for such 
                year.
    (d) Certain Transfers; Allocations Between Programs Under 
Subpart I.--With respect to paragraphs (1)(B)(i) and (2)(A)(ii) 
of subsection (c), the Secretary shall administer any 
reductions under such paragraphs for a fiscal year in 
accordance with the following:
            (1) The reductions shall be made from amounts 
        available for the single program referred to in section 
        2609(d)(2)(C) (relating to supplemental grants).
            (2) The reductions shall be made before the amounts 
        referred to in paragraph (1) are used for purposes of 
        section 2603(a)(4).
            (3) If the amounts referred to in paragraph (1) are 
        not sufficient for making all the reductions, the 
        reductions shall be reduced until the total amount of 
        the reductions equals the total of the amounts referred 
        to in such paragraph.
    (e) Rules of Construction Regarding First Subsequent Fiscal 
Year.--Paragraphs (1) and (2) of subsection (c) apply with 
respect to each series of fiscal years during which a 
metropolitan area is an eligible area under subpart I or a 
transitional area under section 2609 for a fiscal year and then 
for a subsequent fiscal year ceases to be such an area by 
reason of section 2601(b) or 2609(c)(2), respectively, rather 
than applying to a single such series. Paragraph (3) of 
subsection (c) applies with respect to each series of fiscal 
years during which a metropolitan area is a transitional area 
under section 2609 for a fiscal year and then for a subsequent 
fiscal year becomes an eligible area under subpart I, rather 
than applying to a single such series.

               Part B--Care Grant Program 1, 2

                  Subpart I--General Grant Provisions

SEC. 2611. [300FF-21] GRANTS.

    The Secretary shall, subject to the availability of 
appropriations, make grants to States to enable such States to 
improve the quality, availability and organization of health 
care and support services for individuals and families with 
HIV/AIDS. The authority of the Secretary to provide grants 
under part B is subject to section 2626(e)(2) (relating to the 
decrease in perinatal transmission of HIV/AIDS).
---------------------------------------------------------------------------
    \1\ Section 8(a) of Public Law 104-146 (110 Stat. 1372) establishes 
a condition for the receipt of grants under part B. The condition 
relates to notification of spouses of HIV-infected patients.
    \2\ See footnote at the beginning of part A.
---------------------------------------------------------------------------

SEC. 2612. [300FF-22] GENERAL USE OF GRANTS.

    (a) In General.--A State may use amounts provided under 
grants made under section 2611 for--
            (1) core medical services described in subsection 
        (b);
            (2) support services described in subsection (c); 
        and
            (3) administrative expenses described in section 
        2618(b)(3).
    (b) Required Funding for Core Medical Services.--
            (1) In general.--With respect to a grant under 
        section 2611 for a State for a grant year, the State 
        shall, of the portion of the grant remaining after 
        reserving amounts for purposes of subparagraphs (A) and 
        (E)(ii)(I) of section 2618(b)(3), use not less than 75 
        percent to provide core medical services that are 
        needed in the State for individuals with HIV/AIDS who 
        are identified and eligible under this title (including 
        services regarding the co-occurring conditions of the 
        individuals).
            (2) Waiver.--
                    (A) In general.--The Secretary shall waive 
                the application of paragraph (1) with respect 
                to a State for a grant year if the Secretary 
                determines that, within the State--
                            (i) there are no waiting lists for 
                        AIDS Drug Assistance Program services 
                        under section 2616; and
                            (ii) core medical services are 
                        available to all individuals with HIV/
                        AIDS identified and eligible under this 
                        title.
                    (B) Notification of waiver status.--When 
                informing a State that a grant under section 
                2611 is being made to the State for a fiscal 
                year, the Secretary shall inform the State 
                whether a waiver under subparagraph (A) is in 
                effect for the fiscal year.
            (3) Core medical services.--For purposes of this 
        subsection, the term ``core medical services'', with 
        respect to an individual infected with HIV/AIDS 
        (including the co-occurring conditions of the 
        individual) means the following services:
                    (A) Outpatient and ambulatory health 
                services.
                    (B) AIDS Drug Assistance Program treatments 
                in accordance with section 2616.
                    (C) AIDS pharmaceutical assistance.
                    (D) Oral health care.
                    (E) Early intervention services described 
                in subsection (d).
                    (F) Health insurance premium and cost 
                sharing assistance for low-income individuals 
                in accordance with section 2615.
                    (G) Home health care.
                    (H) Medical nutrition therapy.
                    (I) Hospice services.
                    (J) Home and community-based health 
                services as defined under section 2614(c).
                    (K) Mental health services.
                    (L) Substance abuse outpatient care.
                    (M) Medical case management, including 
                treatment adherence services.
    (c) Support Services.--
            (1) In general.--For purposes of this subsection, 
        the term ``support services'' means services, subject 
        to the approval of the Secretary, that are needed for 
        individuals with HIV/AIDS to achieve their medical 
        outcomes (such as respite care for persons caring for 
        individuals with HIV/AIDS, outreach services, medical 
        transportation, linguistic services, and referrals for 
        health care and support services).
            (2) Definition of medical outcomes.--In this 
        subsection, the term ``medical outcomes'' means those 
        outcomes affecting the HIV-related clinical status of 
        an individual with HIV/AIDS.
    (d) Early Intervention Services.--
            (1) In general.--For purposes of this section, the 
        term ``early intervention services'' means HIV/AIDS 
        early intervention services described in section 
        2651(e), with follow-up referral provided for the 
        purpose of facilitating the access of individuals 
        receiving the services to HIV-related health services. 
        The entities through which such services may be 
        provided under the grant include public health 
        departments, emergency rooms, substance abuse and 
        mental health treatment programs, detoxification 
        centers, detention facilities, clinics regarding 
        sexually transmitted diseases, homeless shelters, HIV/
        AIDS counseling and testing sites, health care points 
        of entry specified by States, federally qualified 
        health centers, and entities described in section 
        2652(a) that constitute a point of access to services 
        by maintaining referral relationships.
            (2) Conditions.--With respect to an entity that 
        proposes to provide early intervention services under 
        paragraph (1), such paragraph shall apply only if the 
        entity demonstrates to the satisfaction of the chief 
        elected official for the State involved that--
                    (A) Federal, State, or local funds are 
                otherwise inadequate for the early intervention 
                services the entity proposes to provide; and
                    (B) the entity will expend funds pursuant 
                to such subparagraph to supplement and not 
                supplant other funds available to the entity 
                for the provision of early intervention 
                services for the fiscal year involved.
    (e) Priority for Women, Infants, Children, and Youth.--
            (1) In general.--For the purpose of providing 
        health and support services to infants, children, 
        youth, and women with HIV/AIDS, including treatment 
        measures to prevent the perinatal transmission of HIV, 
        a State shall for each of such populations in the 
        eligible area use, from the grants made for the area 
        under section 2601(a) for a fiscal year, not less than 
        the percentage constituted by the ratio of the 
        population involved (infants, children, youth, or women 
        in such area) with HIV/AIDS to the general population 
        in such area of individuals with HIV/AIDS.
            (2) Waiver.--With respect to the population 
        involved, the Secretary may provide to a State a waiver 
        of the requirement of paragraph (1) if such State 
        demonstrates to the satisfaction of the Secretary that 
        the population is receiving HIV-related health services 
        through the State medicaid program under title XIX of 
        the Social Security Act, the State children's health 
        insurance program under title XXI of such Act, or other 
        Federal or State programs.
    (f) Construction.--A State may not use amounts received 
under a grant awarded under section 2611 to purchase or improve 
land, or to purchase, construct, or permanently improve (other 
than minor remodeling) any building or other facility, or to 
make cash payments to intended recipients of services.

SEC. 2613. [300FF-23] GRANTS TO ESTABLISH HIV CARE CONSORTIA.

    (a) Consortia.--A State may, subject to subsection (f), use 
amounts provided under a grant awarded under section 2611 to 
provide assistance under section 2612(a) to an entity that--
            (1) is an association of one or more public, and 
        one or more nonprofit private, (or private for-profit 
        providers or organizations if such entities are the 
        only available providers of quality HIV care in the 
        area) health care and support service providers and 
        community based organizations operating within areas 
        determined by the State to be most affected by HIV/
        AIDS; and
            (2) agrees to use such assistance for the planning, 
        development and delivery, through the direct provision 
        of services or through entering into agreements with 
        other entities for the provision of such services, of 
        comprehensive outpatient health and support services 
        for individuals with HIV disease,  that may include--
                    (A) essential health services such as case 
                management services, medical, nursing, 
                substance abuse treatment, mental health 
                treatment, and dental care, diagnostics, 
                monitoring, prophylactic treatment for 
                opportunistic infections, treatment education 
                to take place in the context of health care 
                delivery, and medical follow-up services, 
                mental health, developmental, and 
                rehabilitation services, home health and 
                hospice care; and
                    (B) essential support services such as 
                transportation services, attendant care, 
                homemaker services, day or respite care, 
                benefits advocacy, advocacy services provided 
                through public and nonprofit private entities, 
                and services that are incidental to the 
                provision of health care services for 
                individuals with HIV/AIDS including nutrition 
                services, housing referral services, and child 
                welfare and family services (including foster 
                care and adoption services).
An entity or entities of the type described in this subsection 
shall hereinafter be referred to in this title as a 
``consortium'' or ``consortia''.
    (b) Assurances.--
            (1) Requirement.--To receive assistance from a 
        State under subsection (a), an applicant consortium 
        shall provide the State with assurances that--
                    (A) within any locality in which such 
                consortium is to operate, the populations and 
                subpopulations of individuals and families with 
                HIV/AIDS have been identified by the 
                consortium, particularly those experiencing 
                disparities in access and services and those 
                who reside in historically underserved 
                communities;
                    (B) the service plan established under 
                subsection (c)(2) by such consortium is 
                consistent with the comprehensive plan under 
                section 2617(b)(4) and addresses the special 
                care and service needs of the populations and 
                subpopulations identified under subparagraph 
                (A); and
                    (C) except as provided in paragraph (2), 
                the consortium will be a single coordinating 
                entity that will integrate the delivery of 
                services among the populations and 
                subpopulations identified under subparagraph 
                (A).
            (2) Exception.--Subparagraph (C) of paragraph (1) 
        shall not apply to any applicant consortium that the 
        State determines will operate in a community or 
        locality in which it has been demonstrated by the 
        applicant consortium that--
                    (A) subpopulations exist within the 
                community to be served that have unique service 
                requirements; and
                    (B) such unique service requirements cannot 
                be adequately and efficiently addressed by a 
                single consortium serving the entire community 
                or locality.
    (c) Application.--
            (1) In general.--To receive assistance from the 
        State under subsection (a), a consortium shall prepare 
        and submit to the State, an application that--
                    (A) demonstrates that the consortium 
                includes agencies and community-based 
                organizations--
                            (i) with a record of service to 
                        populations and subpopulations with 
                        HIV/AIDS requiring care within the 
                        community to be served; and
                            (ii) that are representative of 
                        populations and subpopulations 
                        reflecting the local incidence of HIV 
                        and that are located in areas in which 
                        such populations reside;
                    (B) demonstrates that the consortium has 
                carried out an assessment of service needs 
                within the geographic area to be served and, 
                after consultation with the entities described 
                in paragraph (2), has established a plan to 
                ensure the delivery of services to meet such 
                identified needs that shall include--
                            (i) assurances that service needs 
                        will be addressed through the 
                        coordination and expansion of existing 
                        programs before new programs are 
                        created;
                            (ii) assurances that, in 
                        metropolitan areas, the geographic area 
                        to be served by the consortium 
                        corresponds to the geographic 
                        boundaries of local health and support 
                        services delivery systems to the extent 
                        practicable;
                            (iii) assurances that, in the case 
                        of services for individuals residing in 
                        rural areas, the applicant consortium 
                        shall deliver case management services 
                        that link available community support 
                        services to appropriate specialized 
                        medical services; and
                            (iv) assurances that the assessment 
                        of service needs and the planning of 
                        the delivery of services will include 
                        participation by individuals with HIV/
                        AIDS;
                    (C) demonstrates that adequate planning has 
                occurred to meet the special needs of families 
                with HIV/AIDS, including family centered and 
                youth centered care;
                    (D) demonstrates that the consortium has 
                created a mechanism to evaluate periodically--
                            (i) the success of the consortium 
                        in responding to identified needs; and
                            (ii) the cost-effectiveness of the 
                        mechanisms employed by the consortium 
                        to deliver comprehensive care;
                    (E) demonstrates that the consortium will 
                report to the State the results of the 
                evaluations described in subparagraph (D) and 
                shall make available to the State or the 
                Secretary, on request, such data and 
                information on the program methodology that may 
                be required to perform an independent 
                evaluation; and
                    (F) demonstrates that adequate planning 
                occurred to address disparities in access and 
                services and historically underserved 
                communities.
            (2) Consultation.--In establishing the plan 
        required under paragraph (1)(B), the consortium shall 
        consult with--
                    (A)(i) the public health agency that 
                provides or supports ambulatory and outpatient 
                HIV-related health care services within the 
                geographic area to be served; or
                    (ii) in the case of a public health agency 
                that does not directly provide such HIV-related 
                health care services such agency shall consult 
                with an entity or entities that directly 
                provide ambulatory and outpatient HIV-related 
                health care services within the geographic area 
                to be served;
                    (B) not less than one community-based 
                organization that is organized solely for the 
                purpose of providing HIV-related support 
                services to individuals with HIV/AIDS;
                    (C) grantees under section 2671, or, if 
                none are operating in the area, representatives 
                in the area of organizations with a history of 
                serving children, youth, women, and families 
                living with HIV; and
                    (D) the types of entities described in 
                section 2602(b)(2).
        The organization to be consulted under subparagraph (B) 
        shall be at the discretion of the applicant consortium.
    (d) Definition.--As used in section 2611, the term ``family 
centered care'' means the system of services described in this 
section that is targeted specifically to the special needs of 
infants, children, women, and families. Family centered care 
shall be based on a partnership between parents, professionals, 
and the community designed to ensure an integrated, 
coordinated, culturally sensitive, and community-based 
continuum of care for children, women, and families with HIV/
AIDS.
    (e) Priority.--In providing assistance under subsection 
(a), the State shall, among applicants that meet the 
requirements of this section, give priority--
            (1) first to consortia that are receiving 
        assistance from the Health Resources and Services 
        Administration for adult and pediatric HIV-related care 
        demonstration projects; and then
            (2) to any other existing HIV care consortia.
    (f) Allocation of Funds; Treatment as Support Services.--
For purposes of the requirement of section 2612(b)(1), 
expenditures of grants under section 2611 for or through 
consortia under this section are deemed to be support services, 
not core medical services. The preceding sentence may not be 
construed as having any legal effect on the provisions of 
subsection (a) that relate to authorized expenditures of the 
grant.

SEC. 2614. [300FF-24] GRANTS FOR HOME- AND COMMUNITY-BASED CARE.

    (a) Uses.--A State may use amounts provided under a grant 
awarded under section 2611 to make grants under section 
2612(b)(3)(J) to entities to--
            (1) provide home- and community-based health 
        services for individuals with HIV/AIDS pursuant to 
        written plans of care prepared by a case management 
        team, that shall include appropriate health care 
        professionals, in such State for providing such 
        services to such individuals;
            (2) provide outreach services to individuals with 
        HIV/AIDS, including those individuals in rural areas; 
        and
            (3) provide for the coordination of the provision 
        of services under this section with the provision of 
        HIV-related health services, including specialty care 
        and vaccinations for hepatitis co-infection, provided 
        by public and private entities.
    (b) Priority.--In awarding grants under subsection (a), a 
State shall give priority to entities that provide assurances 
to the State that--
            (1) such entities will participate in HIV care 
        consortia if such consortia exist within the State; and
            (2) such entities will utilize amounts provided 
        under such grants for the provision of home- and 
        community-based services to low-income individuals with 
        HIV/AIDS.
    (c) Definition.--As used in section 2611, the term ``home- 
and community-based health services''--
            (1) means, with respect to an individual with HIV/
        AIDS, skilled health services furnished to the 
        individual in the individual's home pursuant to a 
        written plan of care established by a case management 
        team, that shall include appropriate health care 
        professionals, for the provision of such services and 
        items described in paragraph (2);
            (2) includes--
                    (A) durable medical equipment;
                    (B) home health aide services and personal 
                care services furnished in the home of the 
                individual;
                    (C) day treatment or other partial 
                hospitalization services;
                    (D) home intravenous and aerosolized drug 
                therapy (including prescription drugs 
                administered as part of such therapy);
                    (E) routine diagnostic testing administered 
                in the home of the individual; and
                    (F) appropriate mental health, 
                developmental, and rehabilitation services; and
            (3) does not include--
                    (A) inpatient hospital services; and
                    (B) nursing home and other long term care 
                facilities.

SEC. 2615. [300FF-25] CONTINUUM OF HEALTH INSURANCE COVERAGE.

    (a) In General.--A State may use amounts received under a 
grant awarded under section 2611 to establish a program of 
financial assistance under section 2612(b)(3)(F) to assist 
eligible low-income individuals with HIV/AIDS in--
            (1) maintaining a continuity of health insurance; 
        or
            (2) receiving medical benefits under a health 
        insurance program, including risk-pools.
    (b) Limitations.--Assistance shall not be utilized under 
subsection (a)--
            (1) to pay any costs associated with the creation, 
        capitalization, or administration of a liability risk 
        pool (other than those costs paid on behalf of 
        individuals as part of premium contributions to 
        existing liability risk pools); and
            (2) to pay any amount expended by a State under 
        title XIX of the Social Security Act.

SEC. 2616. [300FF-26] PROVISION OF TREATMENTS.

    (a) In General.--A State shall use a portion of the amounts 
provided under a grant awarded under section 2611 to establish 
a program under section 2612(b)(3)(B) to provide therapeutics 
to treat HIV/AIDS or prevent the serious deterioration of 
health arising from HIV/AIDS in eligible individuals, including 
measures for the prevention and treatment of opportunistic 
infections.
    (b) Eligible Individual.--To be eligible to receive 
assistance from a State under this section an individual 
shall--
            (1) have a medical diagnosis of HIV/AIDS; and
            (2) be a low-income individual, as defined by the 
        State.
    (c) State Duties.--In carrying out this section the State 
shall--
            (1) ensure that the therapeutics included on the 
        list of classes of core antiretroviral therapeutics 
        established by the Secretary under subsection (e) are, 
        at a minimum, the treatments provided by the State 
        pursuant to this section;
            (2) provide assistance for the purchase of 
        treatments determined to be eligible under paragraph 
        (1), and the provision of such ancillary devices that 
        are essential to administer such treatments;
            (3) provide outreach to individuals with HIV/AIDS, 
        and as appropriate to the families of such individuals;
            (4) facilitate access to treatments for such 
        individuals;
            (5) document the progress made in making 
        therapeutics described in subsection (a) available to 
        individuals eligible for assistance under this section; 
        and
            (6) encourage, support, and enhance adherence to 
        and compliance with treatment regimens, including 
        related medical monitoring.
Of the amount reserved by a State for a fiscal year for use 
under this section, the State may not use more than 5 percent 
to carry out services under paragraph (6), except that the 
percentage applicable with respect to such paragraph is 10 
percent if the State demonstrates to the Secretary that such 
additional services are essential and in no way diminish access 
to the therapeutics described in subsection (a).
    (d) Duties of the Secretary.--In carrying out this section, 
the Secretary shall review the current status of State drug 
reimbursement programs established under section 2612(2) and 
assess barriers to the expanded availability of the treatments 
described in subsection (a). The Secretary shall also examine 
the extent to which States coordinate with other grantees under 
this title to reduce barriers to the expanded availability of 
the treatments described in subsection (a).
    (e) List of Classes of Core Antiretroviral Therapeutics.--
For purposes of subsection (c)(1), the Secretary shall develop 
and maintain a list of classes of core antiretroviral 
therapeutics, which list shall be based on the therapeutics 
included in the guidelines of the Secretary known as the 
Clinical Practice Guidelines for Use of HIV/AIDS Drugs, 
relating to drugs needed to manage symptoms associated with 
HIV. The preceding sentence does not affect the authority of 
the Secretary to modify such Guidelines.
    (f) Use of Health Insurance and Plans.--
            (1) In general.--In carrying out subsection (a), a 
        State may expend a grant under section 2611 to provide 
        the therapeutics described in such subsection by paying 
        on behalf of individuals with HIV/AIDS the costs of 
        purchasing or maintaining health insurance or plans 
        whose coverage includes a full range of such 
        therapeutics and appropriate primary care services.
            (2) Limitation.--The authority established in 
        paragraph (1) applies only to the extent that, for the 
        fiscal year involved, the costs of the health insurance 
        or plans to be purchased or maintained under such 
        paragraph do not exceed the costs of otherwise 
        providing therapeutics described in subsection (a).
    (g) Drug Rebate Program.--A State shall ensure that any 
drug rebates received on drugs purchased from funds provided 
pursuant to this section are applied to activities supported 
under this subpart, with priority given to activities described 
under this section.

SEC. 2617. [300FF-27] STATE APPLICATION.

    (a) In General.--The Secretary shall not make a grant to a 
State under section 2611 for a fiscal year unless the State 
prepares and submits, to the Secretary, an application at such 
time, in such form, and containing such agreements, assurances, 
and information as the Secretary determines to be necessary to 
carry out section 2611.
    (b) Description of Intended Uses and Agreements.--The 
application submitted under subsection (a) shall contain--
            (1) a detailed description of the HIV-related 
        services provided in the State to individuals and 
        families with HIV/AIDS during the year preceding the 
        year for which the grant is requested, and the number 
        of individuals and families receiving such services, 
        that shall include--
                    (A) a description of the types of programs 
                operated or funded by the State for the 
                provision of HIV-related services during the 
                year preceding the year for which the grant is 
                requested and the methods utilized by the State 
                to finance such programs;
                    (B) an accounting of the amount of funds 
                that the State has expended for such services 
                and programs during the year preceding the year 
                for which the grant is requested; and
                    (C) information concerning--
                            (i) the number of individuals to be 
                        served with assistance provided under 
                        the grant;
                            (ii) demographic data on the 
                        population of the individuals to be 
                        served;
                            (iii) the average cost of providing 
                        each category of HIV-related health 
                        services and the extent to which such 
                        cost is paid by third-party payors; and
                            (iv) the aggregate amounts expended 
                        for each such category of services;
            (2) a determination of the size and demographics of 
        the population of individuals with HIV/AIDS in the 
        State;
            (3) a determination of the needs of such 
        population, with particular attention to--
                    (A) individuals with HIV/AIDS who know 
                their HIV status and are not receiving HIV-
                related services; and
                    (B) disparities in access and services 
                among affected subpopulations and historically 
                underserved communities;
            (4) the designation of a lead State agency that 
        shall--
                    (A) administer all assistance received 
                under section 2611;
                    (B) conduct the needs assessment and 
                prepare the State plan under paragraph (3);
                    (C) prepare all applications for assistance 
                under section 2611;
                    (D) receive notices with respect to 
                programs under this title;
                    (E) every 2 years, collect and submit to 
                the Secretary all audits, consistent with 
                Office of Management and Budget circular A133, 
                from grantees within the State, including 
                audits regarding funds expended in accordance 
                with section 2611; and
                    (F) carry out any other duties determined 
                appropriate by the Secretary to facilitate the 
                coordination of programs under this title.
            (5) a comprehensive plan that describes the 
        organization and delivery of HIV health care and 
        support services to be funded with assistance received 
        under section 2611 that shall include a description of 
        the purposes for which the State intends to use such 
        assistance, and that--
                    (A) \1\ establishes priorities for the 
                allocation of funds within the State based on--
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    \1\The placement of subparagraphs (A) through (C) is according to 
the probable intent of the Congress. Section 205(a)(3) of Public Law 
106-345 (114 Stat. 1332, 1333) amended paragraph (4) by redesignating 
subparagraphs (A) through (C) as subparagraphs (D) through (F), and 
then instructed that new subparagraphs (A) through (C) be inserted 
before ``subparagraph (C)''. The amendment probably should have 
instructed that the new subparagraphs be inserted before subparagraph 
(D), as redesignated.
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                            (i) size and demographics of the 
                        population of individuals with HIV/AIDS 
                        (as determined under paragraph (2)) and 
                        the needs of such population (as 
                        determined under paragraph (3));
                            (ii) availability of other 
                        governmental and non-governmental 
                        resources, including the State medicaid 
                        plan under title XIX of the Social 
                        Security Act and the State Children's 
                        Health Insurance Program under title 
                        XXI of such Act to cover health care 
                        costs of eligible individuals and 
                        families with HIV/AIDS;
                            (iii) capacity development needs 
                        resulting from disparities in the 
                        availability of HIV-related services in 
                        historically underserved communities 
                        and rural communities; and
                            (iv) the efficiency of the 
                        administrative mechanism of the State 
                        for rapidly allocating funds to the 
                        areas of greatest need within the 
                        State;
                    (B) includes a strategy for identifying 
                individuals who know their HIV status and are 
                not receiving such services and for informing 
                the individuals of and enabling the individuals 
                to utilize the services, giving particular 
                attention to eliminating disparities in access 
                and services among affected subpopulations and 
                historically underserved communities, and 
                including discrete goals, a timetable, and an 
                appropriate allocation of funds;
                    (C) includes a strategy to coordinate the 
                provision of such services with programs for 
                HIV prevention (including outreach and early 
                intervention) and for the prevention and 
                treatment of substance abuse (including 
                programs that provide comprehensive treatment 
                services for such abuse);
                    (D) describes the services and activities 
                to be provided and an explanation of the manner 
                in which the elements of the program to be 
                implemented by the State with such assistance 
                will maximize the quality of health and support 
                services available to individuals with HIV/AIDS 
                throughout the State;
                    (E) provides a description of the manner in 
                which services funded with assistance provided 
                under section 2611 will be coordinated with 
                other available related services for 
                individuals with HIV/AIDS;
                    (F) provides a description of how the 
                allocation and utilization of resources are 
                consistent with the statewide coordinated 
                statement of need (including traditionally 
                underserved populations and subpopulations) 
                developed in partnership with other grantees in 
                the State that receive funding under this 
                title; and
                    (G) includes key outcomes to be measured by 
                all entities in the State receiving assistance 
                under this title; and
            (6) an assurance that the public health agency 
        administering the grant for the State will periodically 
        convene a meeting of individuals with HIV/AIDS, members 
        of a Federally recognized Indian tribe as represented 
        in the State, representatives of grantees under each 
        part under this title, providers, and public agency 
        representatives for the purpose of developing a 
        statewide coordinated statement of need;
            (7) an assurance by the State that--
                    (A) the public health agency that is 
                administering the grant for the State engages 
                in a public advisory planning process, 
                including public hearings, that includes the 
                participants under paragraph (6), and the types 
                of entities described in section 2602(b)(2), in 
                developing the comprehensive plan under 
                paragraph (5) and commenting on the 
                implementation of such plan;
                    (B) the State will--
                            (i) to the maximum extent 
                        practicable, ensure that HIV-related 
                        health care and support services 
                        delivered pursuant to a program 
                        established with assistance provided 
                        under section 2611 will be provided 
                        without regard to the ability of the 
                        individual to pay for such services and 
                        without regard to the current or past 
                        health condition of the individual with 
                        HIV/AIDS;
                            (ii) ensure that such services will 
                        be provided in a setting that is 
                        accessible to low-income individuals 
                        with HIV/AIDS;
                            (iii) provide outreach to low-
                        income individuals with HIV/AIDS to 
                        inform such individuals of the services 
                        available under section 2611; and
                            (iv) in the case of a State that 
                        intends to use amounts provided under 
                        the grant for purposes described in 
                        2615 \1\, submit a plan to the 
                        Secretary that demonstrates that the 
                        State has established a program that 
                        assures that--
---------------------------------------------------------------------------
    \1\ The word ``section'' probably should appear before ``2615''. 
Section 12(c)(3) of Public Law 104-146 (110 Stat. 1373) provides that 
subsection (b)(3)(B)(iv) is amended by inserting ``section'' before 
``2615'', but the amendment cannot be executed because the term 
``2615'' does not appear in paragraph (3)(B)(iv). The term formerly did 
appear in such paragraph, but former paragraph (3) was redesignated as 
paragraph (4) by section 3(c)(4)(B) of such Public Law (110 Stat. 
1355).
---------------------------------------------------------------------------
                                    (I) such amounts will be 
                                targeted to individuals who 
                                would not otherwise be able to 
                                afford health insurance 
                                coverage; and
                                    (II) income, asset, and 
                                medical expense criteria will 
                                be established and applied by 
                                the State to identify those 
                                individuals who qualify for 
                                assistance under such program, 
                                and information concerning such 
                                criteria shall be made 
                                available to the public;
                    (C) the State will provide for periodic 
                independent peer review to assess the quality 
                and appropriateness of health and support 
                services provided by entities that receive 
                funds from the State under section 2611;
                    (D) the State will permit and cooperate 
                with any Federal investigations undertaken 
                regarding programs conducted under section 
                2611;
                    (E) the State will maintain HIV-related 
                activities at a level that is equal to not less 
                than the level of such expenditures by the 
                State for the 1-year period preceding the 
                fiscal year for which the State is applying to 
                receive a grant under section 2611;
                    (F) the State will ensure that grant funds 
                are not utilized to make payments for any item 
                or service to the extent that payment has been 
                made, or can reasonably be expected to be made, 
                with respect to that item or service--
                            (i) under any State compensation 
                        program, under an insurance policy, or 
                        under any Federal or State health 
                        benefits program; or
                            (ii) by an entity that provides 
                        health services on a prepaid basis 
                        (except for a program administered by 
                        or providing the services of the Indian 
                        Health Service); and
                    (G) entities within areas in which 
                activities under the grant are carried out will 
                maintain appropriate relationships with 
                entities in the area served that constitute key 
                points of access to the health care system for 
                individuals with HIV/AIDS (including emergency 
                rooms, substance abuse treatment programs, 
                detoxification centers, adult and juvenile 
                detention facilities, sexually transmitted 
                disease clinics, HIV counseling and testing 
                sites, mental health programs, and homeless 
                shelters), and other entities under section 
                2612(c) and 2652(a), for the purpose of 
                facilitating early intervention for individuals 
                newly diagnosed with HIV/AIDS and individuals 
                knowledgeable of their HIV status but not in 
                care; and
            (8) a comprehensive plan--
                    (A) containing an identification of 
                individuals with HIV/AIDS as described in 
                clauses (i) through (iii) of section 
                2603(b)(2)(A) and the strategy required under 
                section 2602(b)(4)(D)(iv);
                    (B) describing the estimated number of 
                individuals within the State with HIV/AIDS who 
                do not know their status;
                    (C) describing activities undertaken by the 
                State to find the individuals described in 
                subparagraph (A) and to make such individuals 
                aware of their status;
                    (D) describing the manner in which the 
                State will provide undiagnosed individuals who 
                are made aware of their status with access to 
                medical treatment for their HIV/AIDS; and
                    (E) describing efforts to remove legal 
                barriers, including State laws and regulations, 
                to routine testing.
    (c) Requirements Regarding Imposition of Charges for 
Services.--
            (1) In General.--The Secretary may not make a grant 
        under section 2611 to a State unless the State provides 
        assurances that in the provision of services with 
        assistance provided under the grant--
                    (A) in the case of individuals with an 
                income less than or equal to 100 percent of the 
                official poverty line, the provider will not 
                impose charges on any such individual for the 
                provision of services under the grant;
                    (B) in the case of individuals with an 
                income greater than 100 percent of the official 
                poverty line, the provider--
                            (i) will impose charges on each 
                        such individual for the provision of 
                        such services; and
                            (ii) will impose charges according 
                        to a schedule of charges that is made 
                        available to the public;
                    (C) in the case of individuals with an 
                income greater than 100 percent of the official 
                poverty line and not exceeding 200 percent of 
                such poverty line, the provider will not, for 
                any calendar year, impose charges in an amount 
                exceeding 5 percent of the annual gross income 
                of the individual involved;
                    (D) in the case of individuals with an 
                income greater than 200 percent of the official 
                poverty line and not exceeding 300 percent of 
                such poverty line, the provider will not, for 
                any calendar year, impose charges in an amount 
                exceeding 7 percent of the annual gross income 
                of the individual involved; and
                    (E) in the case of individuals with an 
                income greater than 300 percent of the official 
                poverty line, the provider will not, for any 
                calendar year, impose charges in an amount 
                exceeding 10 percent of the annual gross income 
                of the individual involved.
            (2) Assessment of charge.--With respect to 
        compliance with the assurance made under paragraph (1), 
        a grantee under section 2611 may, in the case of 
        individuals subject to a charge for purposes of such 
        paragraph--
                    (A) assess the amount of the charge in the 
                discretion of the grantee, including imposing 
                only a nominal charge for the provision of 
                services, subject to the provisions of such 
                paragraph regarding public schedules regarding 
                limitation on the maximum amount of charges; 
                and
                    (B) take into consideration the medical 
                expenses of individuals in assessing the amount 
                of the charge, subject to such provisions.
            (3) Applicability of limitation on amount of 
        charge.--The Secretary may not make a grant under 
        section 2611 unless the applicant of the grant agrees 
        that the limitations established in subparagraphs (C), 
        (D), and (E) of paragraph (1) regarding the imposition 
        of charges for services applies to the annual aggregate 
        of charges imposed for such services, without regard to 
        whether they are characterized as enrollment fees, 
        premiums, deductibles, cost sharing, copayments, 
        coinsurance, or other charges.
            (4) Waiver.--
                    (A) In general.--The State shall waive the 
                requirements established in paragraphs (1) 
                through (3) in the case of an entity that does 
                not, in providing health care services, impose 
                a charge or accept reimbursement from any 
                third-party payor, including reimbursement 
                under any insurance policy or under any Federal 
                or State health benefits program.
                    (B) Determination.--A determination by the 
                State of whether an entity referred to in 
                subparagraph (A) meets the criteria for a 
                waiver under such subparagraph shall be made 
                without regard to whether the entity accepts 
                voluntary donations regarding the provision of 
                services to the public.
    (d) Requirement of Matching Funds Regarding State 
Allotments.--
            (1) In general.--In the case of any State to which 
        the criterion described in paragraph (3) applies, the 
        Secretary may not make a grant under section 2611 
        unless the State agrees that, with respect to the costs 
        to be incurred by the State in carrying out the program 
        for which the grant was awarded, the State will, 
        subject to subsection (b)(2), make available (directly 
        or through donations from public or private entities) 
        non-Federal contributions toward such costs in an 
        amount equal to--
                    (A) for the first fiscal year of payments 
                under the grant, not less than 16\2/3\ percent 
                of such costs ($1 for each $5 of Federal funds 
                provided in the grant);
                    (B) for any second fiscal year of such 
                payments, not less than 20 percent of such 
                costs ($1 for each $4 of Federal funds provided 
                in the grant);
                    (C) for any third fiscal year of such 
                payments, not less than 25 percent of such 
                costs ($1 for each $3 of Federal funds provided 
                in the grant);
                    (D) for any fourth fiscal year of such 
                payments, not less than 33\1/3\ percent of such 
                costs ($1 for each $2 of Federal funds provided 
                in the grant); and
                    (E) for any subsequent fiscal year of such 
                payments, not less than 33\1/3\ percent of such 
                costs ($1 for each $2 of Federal funds provided 
                in the grant).
            (2) Determination of amount of non-federal 
        contribution.--
                    (A) In general.--Non-Federal contributions 
                required in paragraph (1) may be in cash or in 
                kind, fairly evaluated, including plant, 
                equipment, or services. Amounts provided by the 
                Federal Government, and any portion of any 
                service subsidized by the Federal Government, 
                may not be included in determining the amount 
                of such non-Federal contributions.
                    (B) Inclusion of certain amounts.--
                            (i) In making a determination of 
                        the amount of non-Federal contributions 
                        made by a State for purposes of 
                        paragraph (1), the Secretary shall, 
                        subject to clause (ii), include any 
                        non-Federal contributions provided by 
                        the State for HIV-related services, 
                        without regard to whether the 
                        contributions are made for programs 
                        established pursuant to this title;
                            (ii) In making a determination for 
                        purposes of clause (i), the Secretary 
                        may not include any non-Federal 
                        contributions provided by the State as 
                        a condition of receiving Federal funds 
                        under any program under this title 
                        (except for the program established in 
                        section 2611) or under other provisions 
                        of law.
            (3) Applicability of requirement.--
                    (A) Number of cases.--A State referred to 
                in paragraph (1) is any State for which the 
                number of cases of HIV/AIDS reported to and 
                confirmed by the Director of the Centers for 
                Disease Control and Prevention for the period 
                described in subparagraph (B) constitutes in 
                excess of 1 percent of the aggregate number of 
                such cases reported to and confirmed by the 
                Director for such period for the United States.
                    (B) Period of time.--The period referred to 
                in subparagraph (A) is the 2-year period 
                preceding the fiscal year for which the State 
                involved is applying to receive a grant under 
                subsection (a).
                    (C) Puerto Rico.--For purposes of paragraph 
                (1), the number of cases of HIV/AIDS reported 
                and confirmed for the Commonwealth of Puerto 
                Rico for any fiscal year shall be deemed to be 
                less than 1 percent.
            (4) Diminished state contribution.--With respect to 
        a State that does not make available the entire amount 
        of the non-Federal contribution referred to in 
        paragraph (1), the State shall continue to be eligible 
        to receive Federal funds under a grant under section 
        2611, except that the Secretary in providing Federal 
        funds under the grant shall provide such funds (in 
        accordance with the ratios prescribed in paragraph (1)) 
        only with respect to the amount of funds contributed by 
        such State.

SEC. 2618. [300FF-28] DISTRIBUTION OF FUNDS.

    (a) Amount of Grant to State.--
            (1) Minimum allotment.--Subject to the extent of 
        amounts made available under section 2623, the amount 
        of a grant to be made under section 2611 for--
                    (A) each of the 50 States, the District of 
                Columbia, Guam, and the Virgin Islands 
                (referred to in this paragraph as a ``covered 
                State'') for a fiscal year shall be the greater 
                of--
                            (i)(I) with respect to a covered 
                        State that has less than 90 living 
                        cases of AIDS, as determined under 
                        paragraph (2)(D), $200,000; or
                            (II) with respect to a covered 
                        State that has 90 or more living cases 
                        of AIDS, as determined under paragraph 
                        (2)(D), $500,000; and
                            (ii) an amount determined under 
                        paragraph (2) and then, as applicable, 
                        increased under paragraph (2)(H); and
                    (B) each territory other than Guam and the 
                Virgin Islands shall be the greater of $50,000 
                or an amount determined under paragraph (2).
            (2) Determination.--
                    (A) Formula.--For purposes of paragraph 
                (1), the amount referred to in this paragraph 
                for a State (including a territory) for a 
                fiscal year is, subject to subparagraphs (E) 
                and (F)--
                            (i) an amount equal to the amount 
                        made available under section 2623 for 
                        the fiscal year involved for grants 
                        pursuant to paragraph (1), subject to 
                        subparagraph (F); and
                            (ii) the percentage constituted by 
                        the sum of--
                                    (I) the product of 0.75 and 
                                the ratio of the State 
                                distribution factor for the 
                                State or territory (as 
                                determined under subsection 
                                (B)) to the sum of the 
                                respective State distribution 
                                factors for all States or 
                                territories;
                                    (II) the product of .20 and 
                                the ratio of the non-EMA 
                                distribution factor for the 
                                State or territory (as 
                                determined under subparagraph 
                                (C)) to the sum of the 
                                respective non-EMA distribution 
                                factors for all States or 
                                territories; and
                                    (III) if the State does not 
                                for such fiscal year contain 
                                any area that is an eligible 
                                area under subpart I of part A 
                                or any area that is a 
                                transitional area under section 
                                2609 (referred to in this 
                                subclause as a ``no-EMA 
                                State''), the product of 0.05 
                                and the ratio of the number of 
                                cases that applies for the 
                                State under subparagraph (D) to 
                                the sum of the respective 
                                numbers of cases that so apply 
                                for all no-EMA States.
                    (B) State distribution factor.--For 
                purposes of subparagraph (A)(ii)(I), the term 
                ``State distribution factor'' means an amount 
                equal to the number of living cases of HIV/AIDS 
                in the State involved, as determined under 
                subparagraph (D).
                    (C) Non-ema distribution factor.--For 
                purposes of subparagraph (A)(ii)(II), the term 
                ``non-ema distribution factor'' means an amount 
                equal to the sum of--
                            (i) the number of living cases of 
                        HIV/AIDS in the State involved, as 
                        determined under subparagraph (D); less
                            (ii) a number equal to the sum of--
                                    (I) the total number of 
                                living cases of HIV/AIDS that 
                                are within areas in such State 
                                that are eligible areas under 
                                subpart I of part A for the 
                                fiscal year involved, which 
                                individual number for an area 
                                is the number that applies 
                                under section 2601 for the area 
                                for such fiscal year; and
                                    (II) the total number of 
                                such cases that are within 
                                areas in such State that are 
                                transitional areas under 
                                section 2609 for such fiscal 
                                year, which individual number 
                                for an area is the number that 
                                applies under such section for 
                                the fiscal year.
                    (D) Living cases of hiv/aids.--
                            (i) Requirement of names-based 
                        reporting.--Except as provided in 
                        clause (ii), the number determined 
                        under this subparagraph for a State for 
                        a fiscal year for purposes of 
                        subparagraph (B) is the number of 
                        living names-based cases of HIV/AIDS in 
                        the State that, as of December 31 of 
                        the most recent calendar year for which 
                        such data is available, have been 
                        reported to and confirmed by the 
                        Director of the Centers for Disease 
                        Control and Prevention.
                            (ii) Transition period; exemption 
                        regarding non-aids cases.--For each of 
                        the fiscal years 2007 through 2012, a 
                        State is, subject to clauses (iii) 
                        through (v), exempt from the 
                        requirement under clause (i) that 
                        living non-AIDS names-based cases of 
                        HIV be reported unless--
                                    (I) a system was in 
                                operation as of December 31, 
                                2005, that provides 
                                sufficiently accurate and 
                                reliable names-based reporting 
                                of such cases throughout the 
                                State, subject to clause (vii); 
                                or
                                    (II) no later than the 
                                beginning of fiscal year 2008 
                                or a subsequent fiscal year 
                                through fiscal year 2012, the 
                                Secretary, after consultation 
                                with the chief executive of the 
                                State, determines that a system 
                                has become operational in the 
                                State that provides 
                                sufficiently accurate and 
                                reliable names-based reporting 
                                of such cases throughout the 
                                State.
                            (iii) Requirements for exemption 
                        for fiscal year 2007.--For fiscal year 
                        2007, an exemption under clause (ii) 
                        for a State applies only if, by October 
                        1, 2006--
                                    (I)(aa) the State had 
                                submitted to the Secretary a 
                                plan for making the transition 
                                to sufficiently accurate and 
                                reliable names-based reporting 
                                of living non-AIDS cases of 
                                HIV; or
                                    (bb) all statutory changes 
                                necessary to provide for 
                                sufficiently accurate and 
                                reliable reporting of such 
                                cases had been made; and
                                    (II) the State had agreed 
                                that, by April 1, 2008, the 
                                State will begin accurate and 
                                reliable names-based reporting 
                                of such cases, except that such 
                                agreement is not required to 
                                provide that, as of such date, 
                                the system for such reporting 
                                be fully sufficient with 
                                respect to accuracy and 
                                reliability throughout the 
                                area.
                            (iv) Requirement for exemption as 
                        of fiscal year 2008.--For each of the 
                        fiscal years 2008 through 2012, an 
                        exemption under clause (ii) for a State 
                        applies only if, as of April 1, 2008, 
                        the State is substantially in 
                        compliance with the agreement under 
                        clause (iii)(II).
                            (v) Progress toward names-based 
                        reporting.--For fiscal year 2009 or a 
                        subsequent fiscal year, the Secretary 
                        may terminate an exemption under clause 
                        (ii) for a State if the State submitted 
                        a plan under clause (iii)(I)(aa) and 
                        the Secretary determines that the State 
                        is not substantially following the 
                        plan.
                            (vi) Counting of cases in areas 
                        with exemptions.--
                                    (I) In general.--With 
                                respect to a State that is 
                                under a reporting system for 
                                living non-AIDS cases of HIV 
                                that is not names-based 
                                (referred to in this 
                                subparagraph as ``code-based 
                                reporting''), the Secretary 
                                shall, for purposes of this 
                                subparagraph, modify the number 
                                of such cases reported for the 
                                State in order to adjust for 
                                duplicative reporting in and 
                                among systems that use code-
                                based reporting.
                                    (II) Adjustment rate.--The 
                                adjustment rate under subclause 
                                (I) for a State shall be a 
                                reduction of 5 percent for 
                                fiscal years before fiscal year 
                                2012 (and 6 percent for fiscal 
                                year 2012) in the number of 
                                living non-AIDS cases of HIV 
                                reported for the State.
                                    (III) Increased adjustment 
                                for certain states previously 
                                using code-based reporting.--
                                For purposes of this 
                                subparagraph for each of fiscal 
                                years 2010 through 2012, the 
                                Secretary shall deem the 
                                applicable number of living 
                                cases of HIV/AIDS in a State 
                                that were reported to and 
                                confirmed by the Centers for 
                                Disease Control and Prevention 
                                to be 3 percent higher than the 
                                actual number if--
                                            (aa) there is an 
                                        area in such State that 
                                        satisfies all of the 
                                        conditions described in 
                                        items (aa) through (cc) 
                                        of section 
                                        2603(a)(3)(C)(vi)(III); 
                                        or
                                            (bb)(AA) fiscal 
                                        year 2007 was the first 
                                        year in which the count 
                                        of living non-AIDS 
                                        cases of HIV in such 
                                        area, for purposes of 
                                        this part, was based on 
                                        a names-based reporting 
                                        system; and
                                            (BB) the amount of 
                                        funding that such State 
                                        received under this 
                                        part for fiscal year 
                                        2007 was less than 70 
                                        percent of the amount 
                                        of funding that such 
                                        State received under 
                                        such part for fiscal 
                                        year 2006.
                            (vii) List of states meeting 
                        standard regarding december 31, 2005.--
                                    (I) In general.--If a State 
                                is specified in subclause (II), 
                                the State shall be considered 
                                to meet the standard described 
                                in clause (ii)(I). No other 
                                State may be considered to meet 
                                such standard.
                                    (II) Relevant states.--For 
                                purposes of subclause (I), the 
                                States specified in this 
                                subclause are the following: 
                                Alaska, Alabama, Arkansas, 
                                Arizona, Colorado, Florida, 
                                Indiana, Iowa, Idaho, Kansas, 
                                Louisiana, Michigan, Minnesota, 
                                Missouri, Mississippi, North 
                                Carolina, North Dakota, 
                                Nebraska, New Jersey, New 
                                Mexico, New York, Nevada, Ohio, 
                                Oklahoma, South Carolina, South 
                                Dakota, Tennessee, Texas, Utah, 
                                Virginia, Wisconsin, West 
                                Virginia, Wyoming, Guam, and 
                                the Virgin Islands.
                            (viii) Rules of construction 
                        regarding acceptance of reports.--
                                    (I) Cases of aids.--With 
                                respect to a State that is 
                                subject to the requirement 
                                under clause (i) and is not in 
                                compliance with the requirement 
                                for names-based reporting of 
                                living non-AIDS cases of HIV, 
                                the Secretary shall, 
                                notwithstanding such 
                                noncompliance, accept reports 
                                of living cases of AIDS that 
                                are in accordance with such 
                                clause.
                                    (II) Applicability of 
                                exemption requirements.--The 
                                provisions of clauses (ii) 
                                through (vii) may not be 
                                construed as having any legal 
                                effect for fiscal year 2013 or 
                                any subsequent fiscal year, and 
                                accordingly, the status of a 
                                State for purposes of such 
                                clauses may not be considered 
                                after fiscal year 2012.
                            (ix) Program for detecting 
                        inaccurate or fraudulent counting.--The 
                        Secretary shall carry out a program to 
                        monitor the reporting of names-based 
                        cases for purposes of this subparagraph 
                        and to detect instances of inaccurate 
                        reporting, including fraudulent 
                        reporting.
                            (x) Future fiscal years.--For 
                        fiscal years beginning with fiscal year 
                        2013, determinations under this 
                        paragraph shall be based only on living 
                        names-based cases of HIV/AIDS with 
                        respect to the State involved.
                    (E) Code-based states; limitation on 
                increase in grant.--
                            (i) In general.--For each of the 
                        fiscal years 2007 through 2012, if 
                        code-based reporting (within the 
                        meaning of subparagraph (D)(vi)) 
                        applies in a State as of the beginning 
                        of the fiscal year involved, then 
                        notwithstanding any other provision of 
                        this paragraph, the amount of the grant 
                        pursuant to paragraph (1) for the State 
                        may not for the fiscal year involved 
                        exceed by more than 5 percent the 
                        amount of the grant pursuant to this 
                        paragraph for the State for the 
                        preceding fiscal year, except that the 
                        limitation under this clause may not 
                        result in a grant pursuant to paragraph 
                        (1) for a fiscal year that is less than 
                        the minimum amount that applies to the 
                        State under such paragraph for such 
                        fiscal year.
                            (ii) Use of amounts involved.--For 
                        each of the fiscal years 2007 through 
                        2012, amounts available as a result of 
                        the limitation under clause (i) shall 
                        be made available by the Secretary as 
                        additional amounts for grants pursuant 
                        to section 2620, subject to 
                        subparagraph (H).
                    (F) \1\ Appropriations for treatment drug 
                program.--
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    \1\ The amendments made by section 203(c) of Public Law 109-415 to 
section 2618(a)(2)(G) have been carried out to subparagraph (F), as 
redesignated by subsection (b)(4) of such Public Law, in order to 
reflect the probable intent of Congress.
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                            (i) Formula grants.--With respect 
                        to the fiscal year involved, if under 
                        section 2623 an appropriations Act 
                        provides an amount exclusively for 
                        carrying out section 2616, the portion 
                        of such amount allocated to a State 
                        shall be the product of--
                            (I) \2\ 100 percent of such amount, 
                        less the percentage reserved under 
                        clause (ii)(V); and
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    \2\ Indentation of subclauses (I) and (II) are so in law. See 
section 206(e)(1) of Public Law 106-345 (114 Stat. 1336).
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                            (II) \2\ the percentage constituted 
                        by the ratio of the State distribution 
                        factor for the State (as determined 
                        under subparagraph (B)) to the sum of 
                        the State distribution factors for all 
                        States;
                        which product shall then, as 
                        applicable, be increased under 
                        subparagraph (H).
                            (ii) Supplemental treatment drug 
                        grants.--
                                    (I) In general.--From 
                                amounts made available under 
                                subclause (V), the Secretary 
                                shall award supplemental grants 
                                to States described in 
                                subclause (II) to enable such 
                                States to purchase and 
                                distribute to eligible 
                                individuals under section 
                                2616(b) pharmaceutical 
                                therapeutics described under 
                                subsections (c)(2) and (e) of 
                                such section.
                                    (II) Eligible states.--For 
                                purposes of subclause (I), a 
                                State shall be an eligible 
                                State if the State did not have 
                                unobligated funds subject to 
                                reallocation under section 
                                2618(d) in the previous fiscal 
                                year and, in accordance with 
                                criteria established by the 
                                Secretary, demonstrates a 
                                severe need for a grant under 
                                this clause. For purposes of 
                                determining severe need, the 
                                Secretary shall consider 
                                eligibility standards, 
                                formulary composition, the 
                                number of eligible individuals 
                                to whom a State is unable to 
                                provide therapeutics described 
                                in section 2616(a), and an 
                                unanticipated increase of 
                                eligible individuals with HIV/
                                AIDS.
                                    (III) State requirements.--
                                The Secretary may not make a 
                                grant to a State under this 
                                clause unless the State agrees 
                                that the State will make 
                                available (directly or through 
                                donations of public or private 
                                entities) non-Federal 
                                contributions toward the 
                                activities to be carried out 
                                under the grant in an amount 
                                equal to $1 for each $4 of 
                                Federal funds provided in the 
                                grant, except that the 
                                Secretary may waive this 
                                subclause if the State has 
                                otherwise fully complied with 
                                section 2617(d) with respect to 
                                the grant year involved. The 
                                provisions of this subclause 
                                shall apply to States that are 
                                not required to comply with 
                                such section 2617(d).
                                    (IV) Use and 
                                coordination.--Amounts made 
                                available under a grant under 
                                this clause shall only be used 
                                by the State to provide HIV/
                                AIDS-related medications. The 
                                State shall coordinate the use 
                                of such amounts with the 
                                amounts otherwise provided 
                                under section 2616(a) in order 
                                to maximize drug coverage.
                                    (V) Funding.--For the 
                                purpose of making grants under 
                                this clause, the Secretary 
                                shall each fiscal year reserve 
                                5 percent of the amount 
                                referred to in clause (i) with 
                                respect to section 2616.
                            (iii) Code-based states; limitation 
                        on increase in formula grant.--The 
                        limitation under subparagraph (E)(i) 
                        applies to grants pursuant to clause 
                        (i) of this subparagraph to the same 
                        extent and in the same manner as such 
                        limitation applies to grants pursuant 
                        to paragraph (1), except that the 
                        reference to minimum grants does not 
                        apply for purposes of this clause. 
                        Amounts available as a result of the 
                        limitation under the preceding sentence 
                        shall be made available by the 
                        Secretary as additional amounts for 
                        grants under clause (ii) of this 
                        subparagraph.
                    (H) \1\ Increase in formula grants.--
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    \1\ So in law. There is no subparagraph (G).
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                            (i) Assurance of amount.--
                                    (I) General rule.--For 
                                fiscal year 2010, the Secretary 
                                shall ensure, subject to 
                                clauses (ii) through (iv), that 
                                the total for a State of the 
                                grant pursuant to paragraph (1) 
                                and the grant pursuant to 
                                subparagraph (F) is not less 
                                than 95 percent of such total 
                                for the State for fiscal year 
                                2009.
                                    (II) Rule of 
                                construction.--With respect to 
                                the application of subclause 
                                (I), the 95 percent requirement 
                                under such subclause shall 
                                apply with respect to each 
                                grant awarded under paragraph 
                                (1) and with respect to each 
                                grant awarded under 
                                subparagraph (F).
                            (ii) Fiscal years 2011 and 2012.--
                        For each of the fiscal years 2011 and 
                        2012, the Secretary shall ensure that 
                        the total for a State of the grant 
                        pursuant to paragraph (1) and the grant 
                        pursuant to subparagraph (F) is not 
                        less than 100 percent of such total for 
                        the State for fiscal year 2010.
                            (iii) Fiscal year 2013.--For fiscal 
                        year 2013, the Secretary shall ensure 
                        that the total for a State of the grant 
                        pursuant to paragraph (1) and the grant 
                        pursuant to subparagraph (F) is not 
                        less than 92.5 percent of such total 
                        for the State for fiscal year 2012.
                            (iv) Source of funds for 
                        increase.--
                                    (I) In general.--From the 
                                amount reserved under section 
                                2623(b)(2) for a fiscal year, 
                                and from amounts available for 
                                such section pursuant to 
                                subsection (d) of this section, 
                                the Secretary shall make 
                                available such amounts as may 
                                be necessary to comply with 
                                clause (i).
                                    (II) Pro rata reduction.--
                                If the amounts referred to in 
                                subclause (I) for a fiscal year 
                                are insufficient to fully 
                                comply with clause (i) for the 
                                year, the Secretary, in order 
                                to provide the additional funds 
                                necessary for such compliance, 
                                shall reduce on a pro rata 
                                basis the amount of each grant 
                                pursuant to paragraph (1) for 
                                the fiscal year, other than 
                                grants for States for which 
                                increases under clause (i) 
                                apply and other than States 
                                described in paragraph 
                                (1)(A)(i)(I). A reduction under 
                                the preceding sentence may not 
                                be made in an amount that would 
                                result in the State involved 
                                becoming eligible for such an 
                                increase.
                            (v) Applicability.--This paragraph 
                        may not be construed as having any 
                        applicability after fiscal year 2013.
    (b) Allocation of Assistance by States.--
            (1) Allowances.--Prior to allocating assistance 
        under this subsection, a State shall consider the unmet 
        needs of those areas that have not received financial 
        assistance under part A.
            (2) Planning and evaluations.--Subject to paragraph 
        (4) and except as provided in paragraph (5), a State 
        may not use more than 10 percent of amounts received 
        under a grant awarded under section 2611 for planning 
        and evaluation activities.
            (3) Administration.--
                    (A) In general.--Subject to paragraph (4), 
                and except as provided in paragraph (5), a 
                State may not use more than 10 percent of 
                amounts received under a grant awarded under 
                section 2611 for administration.
                    (B) Allocations.--In the case of entities 
                and subcontractors to which a State allocates 
                amounts received by the State under a grant 
                under section 2611, the State shall ensure 
                that, of the aggregate amount so allocated, the 
                total of the expenditures by such entities for 
                administrative expenses does not exceed 10 
                percent (without regard to whether particular 
                entities expend more than 10 percent for such 
                expenses).
                    (C) Administrative activities.--For the 
                purposes of subparagraph (A), amounts may be 
                used for administrative activities that include 
                routine grant administration and monitoring 
                activities, including a clinical quality 
                management program under subparagraph (E).
                    (D) Subcontractor administrative costs.--
                For the purposes of this paragraph, 
                subcontractor administrative activities 
                include--
                            (i) usual and recognized overhead, 
                        including established indirect rates 
                        for agencies;
                            (ii) management oversight of 
                        specific programs funded under this 
                        title; and
                            (iii) other types of program 
                        support such as quality assurance, 
                        quality control, and related 
                        activities.
                    (E) Clinical quality management.--
                            (i) Requirement.--Each State that 
                        receives a grant under section 2611 
                        shall provide for the establishment of 
                        a clinical quality management program 
                        to assess the extent to which HIV 
                        health services provided to patients 
                        under the grant are consistent with the 
                        most recent Public Health Service 
                        guidelines for the treatment of HIV/
                        AIDS and related opportunistic 
                        infection, and as applicable, to 
                        develop strategies for ensuring that 
                        such services are consistent with the 
                        guidelines for improvement in the 
                        access to and quality of HIV health 
                        services.
                            (ii) Use of funds.--
                                    (I) In general.--From 
                                amounts received under a grant 
                                awarded under section 2611 for 
                                a fiscal year, a State may use 
                                for activities associated with 
                                the clinical quality management 
                                program required in clause (i) 
                                not to exceed the lesser of--
                                            (aa) 5 percent of 
                                        amounts received under 
                                        the grant; or
                                            (bb) $3,000,000.
                                    (II) Relation to limitation 
                                on administrative expenses.--
                                The costs of a clinical quality 
                                management program under clause 
                                (i) may not be considered 
                                administrative expenses for 
                                purposes of the limitation 
                                established in subparagraph 
                                (A).
            (4) Limitation on use of funds.--Except as provided 
        in paragraph (5), a State may not use more than a total 
        of 15 percent of amounts received under a grant awarded 
        under section 2611 for the purposes described in 
        paragraphs (2) and (3).
            (5) Exception.--With respect to a State that 
        receives the minimum allotment under subsection (a)(1) 
        for a fiscal year, such State, from the amounts 
        received under a grant awarded under section 2611 for 
        such fiscal year for the activities described in 
        paragraphs (2) and (3), may, notwithstanding paragraphs 
        (2) through (4) \1\, use not more than that amount 
        required to support one full-time-equivalent employee.
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    \1\ Section 203(e)(5) of Public Law 109-415 (120 Stat. 2795) struck 
``paragraphs (3)'' and all that follows through ``(5),'' and inserted 
revised text. There were two references to ``paragraphs (3)''. The 
amendment was executed to the first such reference to reflect the 
probable intent of Congress.
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            (6) Construction.--A State may not use amounts 
        received under a grant awarded under section 2611 to 
        purchase or improve land, or to purchase, construct, or 
        permanently improve (other than minor remodeling) any 
        building or other facility, or to make cash payments to 
        intended recipients of services.
    (c) Expedited Distribution.--
            (1) In general.--Not less than 75 percent of the 
        amounts received under a grant awarded to a State under 
        section 2611 shall be obligated to specific programs 
        and projects and made available for expenditure not 
        later than--
                    (A) in the case of the first fiscal year 
                for which amounts are received, 150 days after 
                the receipt of such amounts by the State; and
                    (B) in the case of succeeding fiscal years, 
                120 days after the receipt of such amounts by 
                the State.
            (2) Public comment.--Within the time periods 
        referred to in paragraph (1), the State shall invite 
        and receive public comment concerning methods for the 
        utilization of such amounts.
    (d) Reallocation.--Any portion of a grant made to a State 
under section 2611 for a fiscal year that has not been 
obligated as described in subsection (c) ceases to be available 
to the State and shall be made available by the Secretary for 
grants under section 2620, in addition to amounts made 
available for such grants under section 2623(b)(2).

SEC. 2619. [300FF-29] TECHNICAL ASSISTANCE.

    The Secretary shall provide technical assistance in 
administering and coordinating the activities authorized under 
section 2612, including technical assistance for the 
development and implementation of statewide coordinated 
statements of need.

SEC. 2620. [300FF-29A] SUPPLEMENTAL GRANTS.

    (a) In General.--For the purpose of providing services 
described in section 2612(a), the Secretary shall make grants 
to States--
            (1) whose applications under section 2617 have 
        demonstrated the need in the State, on an objective and 
        quantified basis, for supplemental financial assistance 
        to provide such services; and
            (2) that did not, for the most recent grant year 
        pursuant to section 2618(a)(1) or 2618(a)(2)(F)(i) for 
        which data is available, have more than 5 percent of 
        grant funds under such sections canceled, offset under 
        section 2622(e), or covered by any waivers under 
        section 2622(c).
    (b) Demonstrated Need.--The factors considered by the 
Secretary in determining whether an eligible area has a 
demonstrated need for purposes of subsection (a)(1) may include 
any or all of the following:
            (1) The unmet need for such services, as determined 
        under section 2617(b).
            (2) An increasing need for HIV/AIDS-related 
        services, including relative rates of increase in the 
        number of cases of HIV/AIDS.
            (3) The relative rates of increase in the number of 
        cases of HIV/AIDS within new or emerging 
        subpopulations.
            (4) The current prevalence of HIV/AIDS.
            (5) Relevant factors related to the cost and 
        complexity of delivering health care to individuals 
        with HIV/AIDS in the eligible area.
            (6) The impact of co-morbid factors, including co-
        occurring conditions, determined relevant by the 
        Secretary.
            (7) The prevalence of homelessness.
            (8) The prevalence of individuals described under 
        section 2602(b)(2)(M).
            (9) The relevant factors that limit access to 
        health care, including geographic variation, adequacy 
        of health insurance coverage, and language barriers.
            (10) The impact of a decline in the amount received 
        pursuant to section 2618 on services available to all 
        individuals with HIV/AIDS identified and eligible under 
        this title.
    (c) Priority in Making Grants.--The Secretary shall provide 
funds under this section to a State to address the decline in 
services related to the decline in the amounts received 
pursuant to section 2618 consistent with the grant award to the 
State for fiscal year 2006, to the extent that the factor under 
subsection (b)(10) (relating to a decline in funding) applies 
to the State.
    (d) Report on the Awarding of Supplemental Funds.--Not 
later than 45 days after the awarding of supplemental funds 
under this section, the Secretary shall submit to Congress a 
report concerning such funds. Such report shall include 
information detailing--
            (1) the total amount of supplemental funds 
        available under this section for the year involved;
            (2) the amount of supplemental funds used in 
        accordance with the hold harmless provisions of section 
        2618(a)(2);
            (3) the amount of supplemental funds disbursed 
        pursuant to subsection (c);
            (4) the disbursement of the remainder of the 
        supplemental funds after taking into account the uses 
        described in paragraphs (2) and (3); and
            (5) the rationale used for the amount of funds 
        disbursed as described under paragraphs (2), (3), and 
        (4).
    (e) Core Medical Services.--The provisions of section 
2612(b) apply with respect to a grant under this section to the 
same extent and in the same manner as such provisions apply 
with respect to a grant made pursuant to section 2618(a)(1).
    (f) Applicability of Grant Authority.--The authority to 
make grants under this section applies beginning with the first 
fiscal year for which amounts are made available for such 
grants under section 2623(b)(1).

SEC. 2621. [300FF-30] EMERGING COMMUNITIES.

    (a) In General.--The Secretary shall award supplemental 
grants to States determined to be eligible under subsection (b) 
to enable such States to provide comprehensive services of the 
type described in section 2612(a) to supplement the services 
otherwise provided by the State under a grant under this 
subpart in emerging communities within the State that are not 
eligible to receive grants under part A.
    (b) Eligibility.--To be eligible to receive a supplemental 
grant under subsection (a), a State shall--
            (1) be eligible to receive a grant under this 
        subpart;
            (2) demonstrate the existence in the State of an 
        emerging community as defined in subsection (d)(1);
            (3) agree that the grant will be used to provide 
        funds directly to emerging communities in the State, 
        separately from other funds under this title that are 
        provided by the State to such communities; and
            (4) submit the information described in subsection 
        (c).
    (c) Reporting Requirements.--A State that desires a grant 
under this section shall, as part of the State application 
submitted under section 2617, submit a detailed description of 
the manner in which the State will use amounts received under 
the grant and of the severity of need. Such description shall 
include--
            (1) a report concerning the dissemination of 
        supplemental funds under this section and the plan for 
        the utilization of such funds in the emerging 
        community;
            (2) a demonstration of the existing commitment of 
        local resources, both financial and in-kind;
            (3) a demonstration that the State will maintain 
        HIV-related activities at a level that is equal to not 
        less than the level of such activities in the State for 
        the 1-year period preceding the fiscal year for which 
        the State is applying to receive a grant under section 
        2611;
            (4) a demonstration of the ability of the State to 
        utilize such supplemental financial resources in a 
        manner that is immediately responsive and cost 
        effective;
            (5) a demonstration that the resources will be 
        allocated in accordance with the local demographic 
        incidence of AIDS including appropriate allocations for 
        services for infants, children, women, and families 
        with HIV/AIDS;
            (6) a demonstration of the inclusiveness of the 
        planning process, with particular emphasis on affected 
        communities and individuals with HIV/AIDS; and
            (7) a demonstration of the manner in which the 
        proposed services are consistent with local needs 
        assessments and the statewide coordinated statement of 
        need.
    (d) Definitions of Emerging Community.--For purposes of 
this section, the term ``emerging community'' means a 
metropolitan area (as defined in section 2607) for which there 
has been reported to and confirmed by the Director of the 
Centers for Disease Control and Prevention a cumulative total 
of at least 500, but fewer than 1,000, cases of AIDS during the 
most recent period of 5 calendar years for which such data are 
available.
    (e) Continued Status as Emerging Community.--
Notwithstanding any other provision of this section, a 
metropolitan area that is an emerging community for a fiscal 
year continues to be an emerging community until the 
metropolitan area fails, for three consecutive fiscal years--
            (1) to meet the requirements of subsection (d); and
            (2) to have a cumulative total of 750 or more 
        living cases of AIDS (reported to and confirmed by the 
        Director of the Centers for Disease Control and 
        Prevention) as of December 31 of the most recent 
        calendar year for which such data is available.
    (f) Distribution.--The amount of a grant under subsection 
(a) for a State for a fiscal year shall be an amount equal to 
the product of--
            (1) the amount available under section 2623(b)(1) 
        for the fiscal year; and
            (2) a percentage equal to the ratio constituted by 
        the number of living cases of HIV/AIDS in emerging 
        communities in the State to the sum of the respective 
        numbers of such cases in such communities for all 
        States.

SEC. 2622. [300FF-31A] TIMEFRAME FOR OBLIGATION AND EXPENDITURE OF 
                    GRANT FUNDS.

    (a) Obligation by end of Grant Year.--Effective for fiscal 
year 2007 and subsequent fiscal years, funds from a grant award 
made to a State for a fiscal year pursuant to section 
2618(a)(1) or 2618(a)(2)(F), or under section 2620 or 2621, are 
available for obligation by the State through the end of the 
one-year period beginning on the date in such fiscal year on 
which funds from the award first become available to the State 
(referred to in this section as the ``grant year for the 
award''), except as provided in subsection (c)(1).
    (b) Supplemental Grants; Cancellation of Unobligated 
Balance of Grant Award.--Effective for fiscal year 2007 and 
subsequent fiscal years, if a grant award made to a State for a 
fiscal year pursuant to section 2618(a)(2)(F)(ii), or under 
section 2620 or 2621, has an unobligated balance as of the end 
of the grant year for the award--
            (1) the Secretary shall cancel that unobligated 
        balance of the award, and shall require the State to 
        return any amounts from such balance that have been 
        disbursed to the State; and
            (2) the funds involved shall be made available by 
        the Secretary as additional amounts for grants pursuant 
        to section 2620 for the first fiscal year beginning 
        after the fiscal year in which the Secretary obtains 
        the information necessary for determining that the 
        balance is required under paragraph (1) to be canceled, 
        except that the availability of the funds for such 
        grants is subject to section 2618(a)(2)(H) as applied 
        for such year.
    (c) Formula Grants; Cancellation of Unobligated Balance of 
Grant Award; Waiver Permitting Carryover.--
            (1) In general.--Effective for fiscal year 2007 and 
        subsequent fiscal years, if a grant award made to a 
        State for a fiscal year pursuant to section 2618(a)(1) 
        or 2618(a)(2)(F)(i) has an unobligated balance as of 
        the end of the grant year for the award, the Secretary 
        shall cancel that unobligated balance of the award, and 
        shall require the State to return any amounts from such 
        balance that have been disbursed to the State, unless--
                    (A) before the end of the grant year, the 
                State submits to the Secretary a written 
                application for a waiver of the cancellation, 
                which application includes a description of the 
                purposes for which the State intends to expend 
                the funds involved; and
                    (B) the Secretary approves the waiver.
            (2) Expenditure by end of carryover year.--With 
        respect to a waiver under paragraph (1) that is 
        approved for a balance that is unobligated as of the 
        end of a grant year for an award:
                    (A) The unobligated funds are available for 
                expenditure by the State involved for the one-
                year period beginning upon the expiration of 
                the grant year (referred to in this section as 
                the ``carryover year'').
                    (B) If the funds are not expended by the 
                end of the carryover year, the Secretary shall 
                cancel that unexpended balance of the award, 
                and shall require the State to return any 
                amounts from such balance that have been 
                disbursed to the State.
            (3) Use of cancelled balances.--In the case of any 
        balance of a grant award that is cancelled under 
        paragraph (1) or (2)(B), the grant funds involved shall 
        be made available by the Secretary as additional 
        amounts for grants under section 2620 for the first 
        fiscal year beginning after the fiscal year in which 
        the Secretary obtains the information necessary for 
        determining that the balance is required under such 
        paragraph to be canceled, except that the availability 
        of the funds for such grants is subject to section 
        2618(a)(2)(H) as applied for such year.
            (4) Corresponding reduction in future grant.--
                    (A) In general.--In the case of a State for 
                which a balance from a grant award made 
                pursuant to section 2618(a)(1) or 
                2618(a)(2)(F)(i) is unobligated as of the end 
                of the grant year for the award--
                            (i) the Secretary shall reduce, by 
                        the same amount as such unobligated 
                        balance (less any amount of such 
                        balance that is the subject of a waiver 
                        of cancellation under paragraph (1)), 
                        the amount of the grant under such 
                        section for the first fiscal year 
                        beginning after the fiscal year in 
                        which the Secretary obtains the 
                        information necessary for determining 
                        that such balance was unobligated as of 
                        the end of the grant year (which 
                        requirement for a reduction applies 
                        without regard to whether a waiver 
                        under paragraph (1) has been approved 
                        with respect to such balance); and
                            (ii) the grant funds involved in 
                        such reduction shall be made available 
                        by the Secretary as additional funds 
                        for grants under section 2620 for such 
                        first fiscal year, subject to section 
                        2618(a)(2)(H);
                except that this subparagraph does not apply to 
                the State if the amount of the unobligated 
                balance was 5 percent or less.
                    (B) Relation to increases in grant.--A 
                reduction under subparagraph (A) for a State 
                for a fiscal year may not be taken into account 
                in applying section 2618(a)(2)(H) with respect 
                to the State for the subsequent fiscal year.
    (d) Treatment of Drug Rebates.--For purposes of this 
section, funds that are drug rebates referred to in section 
2616(g) may not be considered part of any grant award referred 
to in subsection (a). If an expenditure of ADAP rebate funds 
would trigger a penalty under this section or a higher penalty 
than would otherwise have applied, the State may request that 
for purposes of this section, the Secretary deem the State's 
unobligated balance to be reduced by the amount of rebate funds 
in the proposed expenditure. Notwithstanding 2618(a)(2)(F), any 
unobligated amount under section 2618(a)(2)(F)(ii)(V) that is 
returned to the Secretary for reallocation shall be used by the 
Secretary for--
            (1) the ADAP supplemental program if the Secretary 
        determines appropriate; or
            (2) for additional amounts for grants pursuant to 
        section 2620.
    (e) Authority Regarding Administration of Provisions.--In 
administering subsections (b) and (c) with respect to the 
unobligated balance of a State, the Secretary may elect to 
reduce the amount of future grants to the State under section 
2618, 2620, or 2621, as applicable, by the amount of any such 
unobligated balance in lieu of cancelling such amount as 
provided for in subsection (b) or (c)(1). In such case, the 
Secretary may permit the State to use such unobligated balance 
for purposes of any such future grant. An amount equal to such 
reduction shall be available for use as additional amounts for 
grants pursuant to section 2620, subject to section 
2618(a)(2)(H). Nothing in this paragraph shall be construed to 
affect the authority of the Secretary under subsections (b) and 
(c), including the authority to grant waivers under subsection 
(c)(1). The reduction in future grants authorized under this 
subsection shall be notwithstanding the penalty required under 
subsection (c)(4) with respect to unobligated funds.

SEC. 2623. AUTHORIZATION OF APPROPRIATIONS.

    (a) In General.--For the purpose of carrying out this 
subpart, there are authorized to be appropriated $1,195,500,000 
for fiscal year 2007, $1,239,500,000 for fiscal year 2008, 
$1,285,200,000 for fiscal year 2009, $1,349,460,000 for fiscal 
year 2010, $1,416,933,000 for fiscal year 2011, $1,487,780,000 
for fiscal year 2012, and $1,562,169,000 for fiscal year 2013. 
Amounts appropriated under the preceding sentence for a fiscal 
year are available for obligation by the Secretary until the 
end of the second succeeding fiscal year.
    (b) Reservation of Amounts.--
            (1) Emerging communities.--Of the amount 
        appropriated under subsection (a) for a fiscal year, 
        the Secretary shall reserve $5,000,000 for grants under 
        section 2621.
            (2) Supplemental grants.--
                    (A) In general.--Of the amount appropriated 
                under subsection (a) for a fiscal year in 
                excess of the 2006 adjusted amount, the 
                Secretary shall reserve \1/3\ for grants under 
                section 2620, except that the availability of 
                the reserved funds for such grants is subject 
                to section 2618(a)(2)(H) as applied for such 
                year, and except that any amount appropriated 
                exclusively for carrying out section 2616 (and, 
                accordingly, distributed under section 
                2618(a)(2)(F)) is not subject to this 
                subparagraph.
                    (B) 2006 adjusted amount.--For purposes of 
                subparagraph (A), the term ``2006 adjusted 
                amount'' means the amount appropriated for 
                fiscal year 2006 under section 2677(b) (as such 
                section was in effect for such fiscal year), 
                excluding any amount appropriated for such year 
                exclusively for carrying out section 2616 (and, 
                accordingly, distributed under section 
                2618(a)(2)(I), as so in effect).

Subpart II--Provisions Concerning Pregnancy and Perinatal Transmission 
                                 of HIV

SEC. 2625. [300FF-33] EARLY DIAGNOSIS GRANT PROGRAM.

    (a) In General.--In the case of States whose laws or 
regulations are in accordance with subsection (b), the 
Secretary, acting through the Centers for Disease Control and 
Prevention, shall make grants to such States for the purposes 
described in subsection (c).
    (b) Description of Compliant States.--For purposes of 
subsection (a), the laws or regulations of a State are in 
accordance with this subsection if, under such laws or 
regulations (including programs carried out pursuant to the 
discretion of State officials), both of the policies described 
in paragraph (1) are in effect, or both of the policies 
described in paragraph (2) are in effect, as follows:
            (1)(A) Voluntary opt-out testing of pregnant women.
            (B) Universal testing of newborns.
            (2)(A) Voluntary opt-out testing of clients at 
        sexually transmitted disease clinics.
            (B) Voluntary opt-out testing of clients at 
        substance abuse treatment centers.
The Secretary shall periodically ensure that the applicable 
policies are being carried out and recertify compliance.
    (c) Use of Funds.--A State may use funds provided under 
subsection (a) for HIV/AIDS testing (including rapid testing), 
prevention counseling, treatment of newborns exposed to HIV/
AIDS, treatment of mothers infected with HIV/AIDS, and costs 
associated with linking those diagnosed with HIV/AIDS to care 
and treatment for HIV/AIDS.
    (d) Application.--A State that is eligible for the grant 
under subsection (a) shall submit an application to the 
Secretary, in such form, in such manner, and containing such 
information as the Secretary may require.
    (e) Limitation on Amount of Grant.--A grant under 
subsection (a) to a State for a fiscal year may not be made in 
an amount exceeding $10,000,000.
    (f) Rule of Construction.--Nothing in this section shall be 
construed to pre-empt State laws regarding HIV/AIDS counseling 
and testing.
    (g) Definitions.--In this section:
            (1) The term ``voluntary opt-out testing'' means 
        HIV/AIDS testing--
                    (A) that is administered to an individual 
                seeking other health care services; and
                    (B) in which--
                            (i) pre-test counseling is not 
                        required but the individual is informed 
                        that the individual will receive an 
                        HIV/AIDS test and the individual may 
                        opt out of such testing; and
                            (ii) for those individuals with a 
                        positive test result, post-test 
                        counseling (including referrals for 
                        care) is provided and confidentiality 
                        is protected.
            (2) The term ``universal testing of newborns'' 
        means HIV/AIDS testing that is administered within 48 
        hours of delivery to--
                    (A) all infants born in the State; or
                    (B) all infants born in the State whose 
                mother's HIV/AIDS status is unknown at the time 
                of delivery.
    (h) Authorization of Appropriations.--Of the funds 
appropriated annually to the Centers for Disease Control and 
Prevention for HIV/AIDS prevention activities, $30,000,000 
shall be made available for each of the fiscal years 2007 
through 2009 for grants under subsection (a), of which 
$20,000,000 shall be made available for grants to States with 
the policies described in subsection (b)(1), and $10,000,000 
shall be made available for grants to States with the policies 
described in subsection (b)(2). Funds provided under this 
section are available until expended.

SEC. 2626.  [300FF-34] PERINATAL TRANSMISSION OF HIV DISEASE; 
                    CONTINGENT REQUIREMENT REGARDING STATE GRANTS UNDER 
                    THIS PART.

    (a) Annual Determination of Reported Cases.--A State shall 
annually determine the rate of reported cases of AIDS as a 
result of perinatal transmission among residents of the State.
    (b) Causes of Perinatal Transmission.--In determining the 
rate under subsection (a), a State shall also determine the 
possible causes of perinatal transmission. Such causes may 
include--
            (1) the inadequate provision within the State of 
        prenatal counseling and testing in accordance with the 
        guidelines issued by the Centers for Disease Control 
        and Prevention;
            (2) the inadequate provision or utilization within 
        the State of appropriate therapy or failure of such 
        therapy to reduce perinatal transmission of HIV, 
        including--
                    (A) that therapy is not available, 
                accessible or offered to mothers; or
                    (B) that available therapy is offered but 
                not accepted by mothers; or
            (3) other factors (which may include the lack of 
        prenatal care) determined relevant by the State.
    (c) CDC Reporting System.--Not later than 4 months after 
the date of enactment of this subpart, the Director of the 
Centers for Disease Control and Prevention shall develop and 
implement a system to be used by States to comply with the 
requirements of subsections (a) and (b). The Director shall 
issue guidelines to ensure that the data collected is 
statistically valid.

SEC. 2627. [300FF-37]  STATE HIV TESTING PROGRAMS ESTABLISHED PRIOR TO 
                    OR AFTER ENACTMENT.

    Nothing in this subpart shall be construed to disqualify a 
State from receiving grants under this title if such State has 
established at any time prior to or after the date of enactment 
of this subpart a program of mandatory HIV testing.

SEC. 2628. [300FF-37A]  RECOMMENDATIONS FOR REDUCING INCIDENCE OF 
                    PERINATAL TRANSMISSION.

    (a) Study by Institute of Medicine.--
            (1) In general.--The Secretary shall request the 
        Institute of Medicine to enter into an agreement with 
        the Secretary under which such Institute conducts a 
        study to provide the following:
                    (A) For the most recent fiscal year for 
                which the information is available, a 
                determination of the number of newborn infants 
                with HIV born in the United States with respect 
                to whom the attending obstetrician for the 
                birth did not know the HIV status of the 
                mother.
                    (B) A determination for each State of any 
                barriers, including legal barriers, that 
                prevent or discourage an obstetrician from 
                making it a routine practice to offer pregnant 
                women an HIV test and a routine practice to 
                test newborn infants for HIV/AIDS in 
                circumstances in which the obstetrician does 
                not know the HIV status of the mother of the 
                infant.
                    (C) Recommendations for each State for 
                reducing the incidence of cases of the 
                perinatal transmission of HIV, including 
                recommendations on removing the barriers 
                identified under subparagraph (B).
        If such Institute declines to conduct the study, the 
        Secretary shall enter into an agreement with another 
        appropriate public or nonprofit private entity to 
        conduct the study.
            (2) Report.--The Secretary shall ensure that, not 
        later than 18 months after the effective date of this 
        section, the study required in paragraph (1) is 
        completed and a report describing the findings made in 
        the study is submitted to the appropriate committees of 
        the Congress, the Secretary, and the chief public 
        health official of each of the States.
    (b) Progress Toward Recommendations.--In fiscal year 2004, 
the Secretary shall collect information from the States 
describing the actions taken by the States toward meeting the 
recommendations specified for the States under subsection 
(a)(1)(C).
    (c) Submission of Reports to Congress.--The Secretary shall 
submit to the appropriate committees of the Congress reports 
describing the information collected under subsection (b).

           Subpart III--Certain Partner Notification Programs

SEC. 2631. [300FF-38] GRANTS FOR PARTNER NOTIFICATION PROGRAMS.

    (a) In General.--In the case of States whose laws or 
regulations are in accordance with subsection (b), the 
Secretary, subject to subsection (c)(2), may make grants to the 
States for carrying out programs to provide partner counseling 
and referral services.
    (b) Description of Compliant State Programs.--For purposes 
of subsection (a), the laws or regulations of a State are in 
accordance with this subsection if under such laws or 
regulations (including programs carried out pursuant to the 
discretion of State officials) the following policies are in 
effect:
            (1) The State requires that the public health 
        officer of the State carry out a program of partner 
        notification to inform partners of individuals with 
        HIV/AIDS that the partners may have been exposed to the 
        disease.
            (2)(A) In the case of a health entity that provides 
        for the performance on an individual of a test for HIV/
        AIDS, or that treats the individual for the disease, 
        the State requires, subject to subparagraph (B), that 
        the entity confidentially report the positive test 
        results to the State public health officer in a manner 
        recommended and approved by the Director of the Centers 
        for Disease Control and Prevention, together with such 
        additional information as may be necessary for carrying 
        out such program.
            (B) The State may provide that the requirement of 
        subparagraph (A) does not apply to the testing of an 
        individual for HIV/AIDS if the individual underwent the 
        testing through a program designed to perform the test 
        and provide the results to the individual without the 
        individual disclosing his or her identity to the 
        program. This subparagraph may not be construed as 
        affecting the requirement of subparagraph (A) with 
        respect to a health entity that treats an individual 
        for HIV/AIDS.
            (3) The program under paragraph (1) is carried out 
        in accordance with the following:
                    (A) Partners are provided with an 
                appropriate opportunity to learn that the 
                partners have been exposed to HIV/AIDS, subject 
                to subparagraph (B).
                    (B) The State does not inform partners of 
                the identity of the infected individuals 
                involved.
                    (C) Counseling and testing for HIV/AIDS are 
                made available to the partners and to infected 
                individuals, and such counseling includes 
                information on modes of transmission for the 
                disease, including information on prenatal and 
                perinatal transmission and preventing 
                transmission.
                    (D) Counseling of infected individuals and 
                their partners includes the provision of 
                information regarding therapeutic measures for 
                preventing and treating the deterioration of 
                the immune system and conditions arising from 
                the disease, and the provision of other 
                prevention-related information.
                    (E) Referrals for appropriate services are 
                provided to partners and infected individuals, 
                including referrals for support services and 
                legal aid.
                    (F) Notifications under subparagraph (A) 
                are provided in person, unless doing so is an 
                unreasonable burden on the State.
                    (G) There is no criminal or civil penalty 
                on, or civil liability for, an infected 
                individual if the individual chooses not to 
                identify the partners of the individual, or the 
                individual does not otherwise cooperate with 
                such program.
                    (H) The failure of the State to notify 
                partners is not a basis for the civil liability 
                of any health entity who under the program 
                reported to the State the identity of the 
                infected individual involved.
                    (I) The State provides that the provisions 
                of the program may not be construed as 
                prohibiting the State from providing a 
                notification under subparagraph (A) without the 
                consent of the infected individual involved.
            (4) The State annually reports to the Director of 
        the Centers for Disease Control and Prevention the 
        number of individuals from whom the names of partners 
        have been sought under the program under paragraph (1), 
        the number of such individuals who provided the names 
        of partners, and the number of partners so named who 
        were notified under the program.
            (5) The State cooperates with such Director in 
        carrying out a national program of partner 
        notification, including the sharing of information 
        between the public health officers of the States.
    (c) Reporting System for Cases of HIV Disease; Preference 
in Making Grants.--In making grants under subsection (a), the 
Secretary shall give preference to States whose reporting 
systems for cases of HIV/AIDS produce data on such cases that 
is sufficiently accurate and reliable for use for purposes of 
section 2618(a)(2)(D)(i).
    (d) Authorization of Appropriations.--For the purpose of 
carrying out this section, there is authorized to be 
appropriated $10,000,000 for each of the fiscal years 2007 
through 2009.

                  Part C--Early Intervention Services

                     Subpart I--Categorical Grants

SEC. 2651. [300FF-51] ESTABLISHMENT OF A PROGRAM.

    (a) In General.--For the purposes described in subsection 
(b), the Secretary, acting through the Administrator of the 
Health Resources and Services Administration, may make grants 
to public and nonprofit private entities specified in section 
2652(a).
    (b) Requirements.--
            (1) In general.--The Secretary may not make a grant 
        under subsection (a) unless the applicant for the grant 
        agrees to expend the grant only for--
                    (A) core medical services described in 
                subsection (c);
                    (B) support services described in 
                subsection (d); and
                    (C) administrative expenses as described in 
                section 2664(g)(3).
            (2) Early intervention services.--An applicant for 
        a grant under subsection (a) shall expend not less than 
        50 percent of the amount received under the grant for 
        the services described in subparagraphs (B) through (E) 
        of subsection (e)(1) for individuals with HIV/AIDS.
    (c) Required Funding for Core Medical Services.--
            (1) In general.--With respect to a grant under 
        subsection (a) to an applicant for a fiscal year, the 
        applicant shall, of the portion of the grant remaining 
        after reserving amounts for purposes of paragraphs (3) 
        and (5) of section 2664(g), use not less than 75 
        percent to provide core medical services that are 
        needed in the area involved for individuals with HIV/
        AIDS who are identified and eligible under this title 
        (including services regarding the co-occurring 
        conditions of the individuals).
            (2) Waiver.--
                    (A) The Secretary shall waive the 
                application of paragraph (1) with respect to an 
                applicant for a grant if the Secretary 
                determines that, within the service area of the 
                applicant--
                            (i) there are no waiting lists for 
                        AIDS Drug Assistance Program services 
                        under section 2616; and
                            (ii) core medical services are 
                        available to all individuals with HIV/
                        AIDS identified and eligible under this 
                        title.
                    (B) Notification of waiver status.--When 
                informing an applicant that a grant under 
                subsection (a) is being made for a fiscal year, 
                the Secretary shall inform the applicant 
                whether a waiver under subparagraph (A) is in 
                effect for the fiscal year.
            (3) Core medical services.--For purposes of this 
        subsection, the term ``core medical services'', with 
        respect to an individual with HIV/AIDS (including the 
        co-occurring conditions of the individual) means the 
        following services:
                    (A) Outpatient and ambulatory health 
                services.
                    (B) AIDS Drug Assistance Program treatments 
                under section 2616.
                    (C) AIDS pharmaceutical assistance.
                    (D) Oral health care.
                    (E) Early intervention services described 
                in subsection (e).
                    (F) Health insurance premium and cost 
                sharing assistance for low-income individuals 
                in accordance with section 2615.
                    (G) Home health care.
                    (H) Medical nutrition therapy.
                    (I) Hospice services.
                    (J) Home and community-based health 
                services as defined under section 2614(c).
                    (K) Mental health services.
                    (L) Substance abuse outpatient care.
                    (M) Medical case management, including 
                treatment adherence services.
    (d) Support Services.--
            (1) In general.--For purposes of this section, the 
        term ``support services'' means services, subject to 
        the approval of the Secretary, that are needed for 
        individuals with HIV/AIDS to achieve their medical 
        outcomes (such as respite care for persons caring for 
        individuals with HIV/AIDS, outreach services, medical 
        transportation, linguistic services, and referrals for 
        health care and support services).
            (2) Definition of medical outcomes.--In this 
        section, the term ``medical outcomes'' means those 
        outcomes affecting the HIV-related clinical status of 
        an individual with HIV/AIDS.
    (e) Specification of Early Intervention Services.--
            (1) In general.--The early intervention services 
        referred to in this section are--
                    (A) counseling individuals with respect to 
                HIV/AIDS in accordance with section 2662;
                    (B) testing individuals with respect to 
                HIV/AIDS, including tests to confirm the 
                presence of the disease, tests to diagnose the 
                extent of the deficiency in the immune system, 
                and tests to provide information on appropriate 
                therapeutic measures for preventing and 
                treating the deterioration of the immune system 
                and for preventing and treating conditions 
                arising from HIV/AIDS;
                    (C) referrals described in paragraph (2);
                    (D) other clinical and diagnostic services 
                regarding HIV/AIDS, and periodic medical 
                evaluations of individuals with HIV/AIDS; and
                    (E) providing the therapeutic measures 
                described in subparagraph (B).
            (2) Referrals.--The services referred to in 
        paragraph (1)(C) are referrals of individuals with HIV/
        AIDS to appropriate providers of health and support 
        services, including, as appropriate--
                    (A) to entities receiving amounts under 
                part A or B for the provision of such services;
                    (B) to biomedical research facilities of 
                institutions of higher education that offer 
                experimental treatment for such disease, or to 
                community-based organizations or other entities 
                that provide such treatment; or
                    (C) to grantees under section 2671, in the 
                case of a pregnant woman.
            (3) Requirement of availability of all early 
        intervention services through each grantee.--
                    (A) In general.--The Secretary may not make 
                a grant under subsection (a) unless the 
                applicant for the grant agrees that each of the 
                early intervention services specified in 
                paragraph (2) will be available through the 
                grantee. With respect to compliance with such 
                agreement, such a grantee may expend the grant 
                to provide the early intervention services 
                directly, and may expend the grant to enter 
                into agreements with public or nonprofit 
                private entities, or private for-profit 
                entities if such entities are the only 
                available provider of quality HIV care in the 
                area, under which the entities provide the 
                services.
                    (B) Other requirements.--Grantees described 
                in--
                            (i) subparagraphs (A), (D), (E), 
                        and (F) of section 2652(a)(1) shall use 
                        not less than 50 percent of the amount 
                        of such a grant to provide the services 
                        described in subparagraphs (A), (B), 
                        (D), and (E) of paragraph (1) directly 
                        and on-site or at sites where other 
                        primary care services are rendered; and
                            (ii) subparagraphs (B) and (C) of 
                        section 2652(a)(1) shall ensure the 
                        availability of early intervention 
                        services through a system of linkages 
                        to community-based primary care 
                        providers, and to establish mechanisms 
                        for the referrals described in 
                        paragraph (1)(C), and for follow-up 
                        concerning such referrals.

SEC. 2652. [300FF-52] MINIMUM QUALIFICATIONS OF GRANTEES.

    (a) Eligible Entities.--
            (1) In general.--The entities referred to in 
        section 2651(a) are public entities and nonprofit 
        private entities that are--
                    (A) federally-qualified health centers 
                under section 1905(l)(2)(B) of the Social 
                Security Act;
                    (B) grantees under section 1001 (regarding 
                family planning) other than States;
                    (C) comprehensive hemophilia diagnostic and 
                treatment centers;
                    (D) rural health clinics;
                    (E) health facilities operated by or 
                pursuant to a contract with the Indian Health 
                Service;
                    (F) community-based organizations, clinics, 
                hospitals and other health facilities that 
                provide early intervention services to those 
                persons infected with HIV/AIDS through 
                intravenous drug use; or
                    (G) nonprofit private entities that provide 
                comprehensive primary care services to 
                populations at risk of HIV/AIDS, including 
                faith-based and community-based organizations.
            (2) Underserved populations.--Entities described in 
        paragraph (1) shall serve underserved populations which 
        may include minority populations and Native American 
        populations, ex-offenders, individuals with 
        comorbidities including hepatitis B or C, mental 
        illness, or substance abuse, low-income populations, 
        inner city populations, and rural populations. \1\;
---------------------------------------------------------------------------
    \1\ See footnote for section 217(a).
---------------------------------------------------------------------------
    (b) Status as Medicaid Provider.--
            (1) In general.--Subject to paragraph (2), the 
        Secretary may not make a grant under section 2651 for 
        the provision of services described in subsection (b) 
        of such section in a State unless, in the case of any 
        such service that is available pursuant to the State 
        plan approved under title XIX of the Social Security 
        Act for the State--
                    (A) the applicant for the grant will 
                provide the service directly, and the applicant 
                has entered into a participation agreement 
                under the State plan and is qualified to 
                receive payments under such plan; or
                    (B) the applicant for the grant will enter 
                into an agreement with a public or nonprofit 
                private entity, or a private for-profit entity 
                if such entity is the only available provider 
                of quality HIV care in the area, under which 
                the entity will provide the service, and the 
                entity has entered into such a participation 
                agreement and is qualified to receive such 
                payments.
            (2) Waiver regarding certain secondary 
        agreements.--
                    (A) In the case of an entity making an 
                agreement pursuant to paragraph (1)(B) 
                regarding the provision of services, the 
                requirement established in such paragraph 
                regarding a participation agreement shall be 
                waived by the Secretary if the entity does not, 
                in providing health care services, impose a 
                charge or accept reimbursement available from 
                any third-party payor, including reimbursement 
                under any insurance policy or under any Federal 
                or State health benefits program.
                    (B) A determination by the Secretary of 
                whether an entity referred to in subparagraph 
                (A) meets the criteria for a waiver under such 
                subparagraph shall be made without regard to 
                whether the entity accepts voluntary donations 
                regarding the provision of services to the 
                public.

SEC. 2653. [300FF-53] PREFERENCES IN MAKING GRANTS.

    (a) In General.--In making grants under section 2651, the 
Secretary shall give preference to any qualified applicant 
experiencing an increase in the burden of providing services 
regarding HIV/AIDS, as indicated by the factors specified in 
subsection (b).
    (b) Specification of Factors.--
            (1) In general.--In the case of the geographic area 
        with respect to which the entity involved is applying 
        for a grant under section 2651, the factors referred to 
        in subsection (a), as determined for the period 
        specified in paragraph (2), are--
                    (A) the number of cases of HIV/AIDS;
                    (B) the rate of increase in such cases;
                    (C) the lack of availability of early 
                intervention services;
                    (D) the number of other cases of sexually 
                transmitted diseases, and the number of cases 
                of tuberculosis and of drug abuse and the 
                number of cases of individuals co-infected with 
                HIV/AIDS and hepatitis B or C;
                    (E) the rate of increase in each of the 
                cases specified in subparagraph (D);
                    (F) the lack of availability of primary 
                health services from providers other than such 
                applicant; and
                    (G) the distance between such area and the 
                nearest community that has an adequate level of 
                availability of appropriate HIV-related 
                services, and the length of time required to 
                travel such distance.
            (2) Relevant period of time.--The period referred 
        to in paragraph (1) is the 2-year period preceding the 
        fiscal year for which the entity involved is applying 
        to receive a grant under section 2651.
    (c) Equitable Allocations.--In providing preferences for 
purposes of subsection (b), the Secretary shall equitably 
allocate the preferences among urban and rural areas.
    (d) Certain Areas.--Of the applicants who qualify for 
preference under this section--
            (1) the Secretary shall give preference to 
        applicants that will expend the grant under section 
        2651 to provide early intervention under such section 
        in rural areas; and
            (2) the Secretary shall give preference to areas 
        that are underserved with respect to such services.

SEC. 2654. [300FF-54] MISCELLANEOUS PROVISIONS.

    (a) Services for Individuals With Hemophilia.--In making 
grants under section 2651, the Secretary shall ensure that any 
such grants made regarding the provision of early intervention 
services to individuals with hemophilia are made through the 
network of comprehensive hemophilia diagnostic and treatment 
centers.
    (b) Technical Assistance.--The Secretary may, directly or 
through grants or contracts, provide technical assistance to 
nonprofit private entities regarding the process of submitting 
to the Secretary applications for grants under section 2651, 
and may provide technical assistance with respect to the 
planning, development, and operation of any program or service 
carried out pursuant to such section.
    (c) Planning and Development Grants.--
            (1) In general.--The Secretary may provide planning 
        grants to public and nonprofit private entities for 
        purposes of--
                    (A) enabling such entities to provide early 
                intervention services; and
                    (B) assisting the entities in expanding 
                their capacity to provide HIV/AIDS-related 
                health services, including early intervention 
                services, in low-income communities and 
                affected subpopulations that are underserved 
                with respect to such services (subject to the 
                condition that a grant pursuant to this 
                subparagraph may not be expended to purchase or 
                improve land, or to purchase, construct, or 
                permanently improve, other than minor 
                remodeling, any building or other facility).
            (2) Requirement.--The Secretary may only award a 
        grant to an entity under paragraph (1) if the Secretary 
        determines that the entity will use such grant to 
        assist the entity in qualifying for a grant under 
        section 2651.
            (3) Preference.--In awarding grants under paragraph 
        (1), the Secretary shall give preference to entities 
        that provide primary care services in rural areas or to 
        underserved populations.
            (4) Amount and duration of grants.--
                    (A) Early intervention services.--A grant 
                under paragraph (1)(A) may be made in an amount 
                not to exceed $50,000.
                    (B) Capacity development.--
                            (i) Amount.--A grant under 
                        paragraph (1)(B) may be made in an 
                        amount not to exceed $150,000.
                            (ii) Duration.--The total duration 
                        of a grant under paragraph (1)(B), 
                        including any renewal, may not exceed 3 
                        years.
            (5) Limitation.--Not to exceed 5 percent of the 
        amount appropriated for a fiscal year under section 
        2655 may be used to carry out this section.

SEC. 2655. [300FF-55] AUTHORIZATION OF APPROPRIATIONS.

    For the purpose of making grants under section 2651, there 
are authorized to be appropriated, $218,600,000 for fiscal year 
2007, $226,700,000 for fiscal year 2008, $235,100,000 for 
fiscal year 2009, $246,855,000 for fiscal year 2010, 
$259,198,000 for fiscal year 2011, $272,158,000 for fiscal year 
2012, and $285,766,000 for fiscal year 2013.

                     Subpart II--General Provisions

SEC. 2661. [300FF-61] CONFIDENTIALITY AND INFORMED CONSENT.

    (a) Confidentiality.--The Secretary may not make a grant 
under this part unless, in the case of any entity applying for 
a grant under section 2651, the entity agrees to ensure that 
information regarding the receipt of early intervention 
services pursuant to the grant is maintained confidentially in 
a manner not inconsistent with applicable law.
    (b) Informed Consent.--The Secretary may not make a grant 
under this part unless the applicant for the grant agrees that, 
in testing an individual for HIV/AIDS, the applicant will test 
an individual only after the individual confirms that the 
decision of the individual with respect to undergoing such 
testing is voluntarily made.

SEC. 2662. [300FF-62] PROVISION OF CERTAIN COUNSELING SERVICES.

    (a) Counseling of Individuals With Negative Test Results.--
The Secretary may not make a grant under this part unless the 
applicant for the grant agrees that, if the results of testing 
conducted for HIV/AIDS indicate that an individual does not 
have such condition, the applicant will provide the individual 
information, including--
            (1) measures for prevention of, exposure to, and 
        transmission of HIV/AIDS, hepatitis B, hepatitis C, and 
        other sexually transmitted diseases;
            (2) the accuracy and reliability of results of 
        testing for HIV/AIDS, hepatitis B, and hepatitis C;
            (3) the significance of the results of such 
        testing, including the potential for developing AIDS, 
        hepatitis B, or hepatitis C;
            (4) the appropriateness of further counseling, 
        testing, and education of the individual regarding HIV/
        AIDS and other sexually transmitted diseases;
            (5) if diagnosed with chronic hepatitis B or 
        hepatitis C co-infection, the potential of developing 
        hepatitis-related liver disease and its impact on HIV/
        AIDS; and
            (6) information regarding the availability of 
        hepatitis B vaccine and information about hepatitis 
        treatments.
    (b) Counseling of Individuals With Positive Test Results.--
The Secretary may not make a grant under this part unless the 
applicant for the grant agrees that, if the results of testing 
for HIV/AIDS indicate that the individual has such condition, 
the applicant will provide to the individual appropriate 
counseling regarding the condition, including--
            (1) information regarding--
                    (A) measures for prevention of, exposure 
                to, and transmission of HIV/AIDS, hepatitis B, 
                and hepatitis C;
                    (B) the accuracy and reliability of results 
                of testing for HIV/AIDS, hepatitis B, and 
                hepatitis C; and
                    (C) the significance of the results of such 
                testing, including the potential for developing 
                AIDS, hepatitis B, or hepatitis C;
            (2) reviewing the appropriateness of further 
        counseling, testing, and education of the individual 
        regarding HIV/AIDS and other sexually transmitted 
        diseases; and
            (3) providing counseling--
                    (A) on the availability, through the 
                applicant, of early intervention services;
                    (B) on the availability in the geographic 
                area of appropriate health care, mental health 
                care, and social and support services, 
                including providing referrals for such 
                services, as appropriate;
                    (C)(i) that explains the benefits of 
                locating and counseling any individual by whom 
                the infected individual may have been exposed 
                to HIV/AIDS, hepatitis B, or hepatitis C and 
                any individual whom the infected individual may 
                have exposed to HIV/AIDS, hepatitis B, or 
                hepatitis C; and
                    (ii) that emphasizes it is the duty of 
                infected individuals to disclose their infected 
                status to their sexual partners and their 
                partners in the sharing of hypodermic needles; 
                that provides advice to infected individuals on 
                the manner in which such disclosures can be 
                made; and that emphasizes that it is the 
                continuing duty of the individuals to avoid any 
                behaviors that will expose others to HIV/AIDS, 
                hepatitis B, or hepatitis C; and
                    (D) on the availability of the services of 
                public health authorities with respect to 
                locating and counseling any individual 
                described in subparagraph (C);
            (4) if diagnosed with chronic hepatitis B or 
        hepatitis C co-infection, the potential of developing 
        hepatitis-related liver disease and its impact on HIV/
        AIDS; and
            (5) information regarding the availability of 
        hepatitis B vaccine.
    (c) Additional Requirements Regarding Appropriate 
Counseling.--The Secretary may not make a grant under this part 
unless the applicant for the grant agrees that, in counseling 
individuals with respect to HIV/AIDS, the applicant will ensure 
that the counseling is provided under conditions appropriate to 
the needs of the individuals.
    (d) Counseling of Emergency Response Employees.--The 
Secretary may not make a grant under this part to a State 
unless the State agrees that, in counseling individuals with 
respect to HIV/AIDS, the State will ensure that, in the case of 
emergency response employees, the counseling is provided to 
such employees under conditions appropriate to the needs of the 
employees regarding the counseling.
    (e) Rule of Construction Regarding Counseling Without 
Testing.--Agreements made pursuant to this section may not be 
construed to prohibit any grantee under this part from 
expending the grant for the purpose of providing counseling 
services described in this section to an individual who does 
not undergo testing for HIV/AIDS as a result of the grantee or 
the individual determining that such testing of the individual 
is not appropriate.

SEC. 2663. [300FF-63] APPLICABILITY OF REQUIREMENTS REGARDING 
                    CONFIDENTIALITY, INFORMED CONSENT, AND COUNSELING.

    The Secretary may not make a grant under this part unless 
the applicant for the grant agrees that, with respect to 
testing for HIV/AIDS, any such testing carried out by the 
applicant with funds appropriated through this Act will be 
carried out in accordance with conditions described in sections 
2661 and 2662.

SEC. 2664. [300FF-64] ADDITIONAL REQUIRED AGREEMENTS.

    (a) Reports to Secretary.--The Secretary may not make a 
grant under this part unless--
            (1) the applicant submits to the Secretary--
                    (A) a specification of the expenditures 
                made by the applicant for early intervention 
                services for the fiscal year preceding the 
                fiscal year for which the applicant is applying 
                to receive the grant;
                    (B) an estimate of the number of 
                individuals to whom the applicant has provided 
                such services for such fiscal year;
                    (C) information regarding how the expected 
                expenditures of the grant are related to the 
                planning process for localities funded under 
                part A (including the planning process 
                described in section 2602) and for States 
                funded under part B (including the planning 
                process described in section 2617(b)); and
                    (D) a specification of the expected 
                expenditures and how those expenditures will 
                improve overall client outcomes, as described 
                in the State plan under section 2617(b);
            (2) the applicant agrees to submit to the Secretary 
        a report providing--
                    (A) the number of individuals to whom the 
                applicant provides early intervention services 
                pursuant to the grant;
                    (B) epidemiological and demographic data on 
                the population of such individuals;
                    (C) the extent to which the costs of HIV-
                related health care for such individuals are 
                paid by third-party payors;
                    (D) the average costs of providing each 
                category of early intervention service; and
                    (E) the aggregate amounts expended for each 
                such category;
            (3) the applicant agrees to provide additional 
        documentation to the Secretary regarding the process 
        used to obtain community input into the design and 
        implementation of activities related to such grant; and
            (4) the applicant agrees to submit, every 2 years, 
        to the lead State agency under section 2617(b)(4) 
        audits, consistent with Office of Management and Budget 
        circular A133, regarding funds expended in accordance 
        with this title and shall include necessary client 
        level data to complete unmet need calculations and 
        Statewide coordinated statements of need process.
    (b) Provision of Opportunities for Anonymous Counseling and 
Testing.--The Secretary may not make a grant under this part 
unless the applicant for the grant agrees that, to the extent 
permitted under State law, regulation or rule, the applicant 
will offer substantial opportunities for an individual--
            (1) to undergo counseling and testing regarding 
        HIV/AIDS without being required to provide any 
        information relating to the identity of the individual; 
        and
            (2) to undergo such counseling and testing through 
        the use of a pseudonym.
    (c) Prohibition Against Requiring Testing as Condition of 
Receiving Other Health Services.--The Secretary may not make a 
grant under this part unless the applicant for the grant agrees 
that, with respect to an individual seeking health services 
from the applicant, the applicant will not require the 
individual to undergo testing for HIV as a condition of 
receiving any health services unless such testing is medically 
indicated in the provision of the health services sought by the 
individual.
    (d) Maintenance of Support.--The Secretary may not make a 
grant under this part unless the applicant for the grant agrees 
to maintain the expenditures of the applicant for early 
intervention services at a level equal to not less than the 
level of such expenditures maintained by the State for the 
fiscal year preceding the fiscal year for which the applicant 
is applying to receive the grant.
    (e) Requirements Regarding Imposition of Charges for 
Services.--
            (1) In general.--The Secretary may not make a grant 
        under this part unless, subject to paragraph (5), the 
        applicant for the grant agrees that--
                    (A) in the case of individuals with an 
                income less than or equal to 100 percent of the 
                official poverty line, the applicant will not 
                impose a charge on any such individual for the 
                provision of early intervention services under 
                the grant;
                    (B) in the case of individuals with an 
                income greater than 100 percent of the official 
                poverty line, the applicant--
                            (i) will impose a charge on each 
                        such individual for the provision of 
                        such services; and
                            (ii) will impose the charge 
                        according to a schedule of charges that 
                        is made available to the public.
            (2) Limitation on charges regarding individuals 
        subject to charges.--With respect to the imposition of 
        a charge for purposes of paragraph (1)(B)(ii), the 
        Secretary may not make a grant under this part unless, 
        subject to paragraph (5), the applicant for the grant 
        agrees that--
                    (A) in the case of individuals with an 
                income greater than 100 percent of the official 
                poverty line and not exceeding 200 percent of 
                such poverty line, the applicant will not, for 
                any calendar year, impose charges in an amount 
                exceeding 5 percent of the annual gross income 
                of the individual involved;
                    (B) in the case of individuals with an 
                income greater than 200 percent of the official 
                poverty line and not exceeding 300 percent of 
                such poverty line, the applicant will not, for 
                any calendar year, impose charges in an amount 
                exceeding 7 percent of the annual gross income 
                of the individual involved; and
                    (C) in the case of individuals with an 
                income greater than 300 percent of the official 
                poverty line, the applicant will not, for any 
                calendar year, impose charges in an amount 
                exceeding 10 percent of the annual gross income 
                of the individual involved.
            (3) Assessment of charge.--With respect to 
        compliance with the agreement made under paragraph (1), 
        a grantee under this part may, in the case of 
        individuals subject to a charge for purposes of such 
        paragraph--
                    (A) assess the amount of the charge in the 
                discretion of the grantee, including imposing 
                only a nominal charge for the provision of 
                services, subject to the provisions of such 
                paragraph regarding public schedules and of 
                paragraph (2) regarding limitations on the 
                maximum amount of charges; and
                    (B) take into consideration the medical 
                expenses of individuals in assessing the amount 
                of the charge, subject to such provisions.
            (4) Applicability of limitation on amount of 
        charge.--The Secretary may not make a grant under this 
        part unless the applicant for the grant agrees that the 
        limitations established in paragraph (2) regarding the 
        imposition of charges for services applies to the 
        annual aggregate of charges imposed for such services, 
        without regard to whether they are characterized as 
        enrollment fees, premiums, deductibles, cost sharing, 
        copayments, coinsurance, or similar charges.
            (5) Waiver regarding certain secondary 
        agreements.--The requirement established in paragraph 
        (1)(B)(i) shall be waived by the Secretary in the case 
        of any entity for whom the Secretary has granted a 
        waiver under section 2652(b)(2).
    (f) Relationship to Items and Services Under Other 
Programs.--
            (1) In general.--The Secretary may not make a grant 
        under this part unless the applicant for the grant 
        agrees that, subject to paragraph (2), the grant will 
        not be expended by the applicant, or by any entity 
        receiving amounts from the applicant for the provision 
        of early intervention services, to make payment for any 
        such service to the extent that payment has been made, 
        or can reasonably be expected to be made, with respect 
        to such service--
                    (A) under any State compensation program, 
                under an insurance policy, or under any Federal 
                or State health benefits program (except for a 
                program administered by or providing the 
                services of the Indian Health Service); or
                    (B) by an entity that provides health 
                services on a prepaid basis.
            (2) Applicability to certain secondary agreements 
        for provision of services.--An agreement made under 
        paragraph (1) shall not apply in the case of an entity 
        through which a grantee under this part provides early 
        intervention services if the Secretary has provided a 
        waiver under section 2652(b)(2) regarding the entity.
    (g) Administration of Grant.--The Secretary may not make a 
grant under this part unless the applicant for the grant agrees 
that--
            (1) the applicant will not expend amounts received 
        pursuant to this part for any purpose other than the 
        purposes described in the subpart under which the grant 
        involved is made;
            (2) the applicant will establish such procedures 
        for fiscal control and fund accounting as may be 
        necessary to ensure proper disbursement and accounting 
        with respect to the grant;
            (3) the applicant will not expend more than 10 
        percent of the grant for administrative expenses with 
        respect to the grant, including planning and 
        evaluation, except that the costs of a clinical quality 
        management program under paragraph (5) may not be 
        considered administrative expenses for purposes of such 
        limitation;
            (4) the applicant will submit evidence that the 
        proposed program is consistent with the statewide 
        coordinated statement of need and agree to participate 
        in the ongoing revision of such statement of need; and
            (5) the applicant will provide for the 
        establishment of a clinical quality management 
        program--
                    (A) to assess the extent to which medical 
                services funded under this title that are 
                provided to patients are consistent with the 
                most recent Public Health Service guidelines 
                for the treatment of HIV/AIDS and related 
                opportunistic infections, and as applicable, to 
                develop strategies for ensuring that such 
                services are consistent with the guidelines; 
                and
                    (B) to ensure that improvements in the 
                access to and quality of HIV health services 
                are addressed.

SEC. 2665. [300FF-65] REQUIREMENT OF SUBMISSION OF APPLICATION 
                    CONTAINING CERTAIN AGREEMENTS AND ASSURANCES.

    The Secretary may not make a grant under this part unless--
            (1) an application for the grant is submitted to 
        the Secretary containing agreements and assurances in 
        accordance with this part and containing the 
        information specified in section 2664(a)(1);
            (2) with respect to such agreements, the 
        application provides assurances of compliance 
        satisfactory to the Secretary; and
            (3) the application otherwise is in such form, is 
        made in such manner, and contains such agreements, 
        assurances, and information as the Secretary determines 
        to be necessary to carry out this part.

SEC. 2666. [300FF-66] PROVISION BY SECRETARY OF SUPPLIES AND SERVICES 
                    IN LIEU OF GRANT FUNDS.

    (a) In General.--Upon the request of a grantee under this 
part, the Secretary may, subject to subsection (b), provide 
supplies, equipment, and services for the purpose of aiding the 
grantee in providing early intervention services and, for such 
purpose, may detail to the State any officer or employee of the 
Department of Health and Human Services.
    (b) Limitation.--With respect to a request described in 
subsection (a), the Secretary shall reduce the amount of 
payments under the grant involved by an amount equal to the 
costs of detailing personnel and the fair market value of any 
supplies, equipment, or services provided by the Secretary. The 
Secretary shall, for the payment of expenses incurred in 
complying with such request, expend the amounts withheld.

SEC. 2667. [300FF-67] USE OF FUNDS.

    Counseling programs carried out under this part--
            (1) shall not be designed to promote or encourage, 
        directly, intravenous drug abuse or sexual activity, 
        homosexual or heterosexual;
            (2) shall be designed to reduce exposure to and 
        transmission of HIV/AIDS by providing accurate 
        information;
            (3) shall provide information on the health risks 
        of promiscuous sexual activity and intravenous drug 
        abuse; amd
            (4) shall provide information on the transmission 
        and prevention of hepatitis A, B, and C, including 
        education about the availability of hepatitis A and B 
        vaccines and assisting patients in identifying 
        vaccination sites.

              PART D--WOMEN, INFANTS, CHILDREN, AND YOUTH

SEC. 2671. [300FF-71] GRANTS FOR COORDINATED SERVICES AND ACCESS TO 
                    RESEARCH FOR WOMEN, INFANTS, CHILDREN, AND YOUTH.

    (a) In General.--The Secretary, acting through the 
Administrator of the Health Resources and Services 
Administration, shall award grants to public and nonprofit 
private entities (including a health facility operated by or 
pursuant to a contract with the Indian Health Service) for the 
purpose of providing family-centered care involving outpatient 
or ambulatory care (directly or through contracts or memoranda 
of understanding) for women, infants, children, and youth with 
HIV/AIDS.
    (b) Additional Services for Patients and Families.--Funds 
provided under grants awarded under subsection (a) may be used 
for the following support services:
            (1) Family-centered care including case management.
            (2) Referrals for additional services including--
                    (A) referrals for inpatient hospital 
                services, treatment for substance abuse, and 
                mental health services; and
                    (B) referrals for other social and support 
                services, as appropriate.
            (3) Additional services necessary to enable the 
        patient and the family to participate in the program 
        established by the applicant pursuant to such 
        subsection including services designed to recruit and 
        retain youth with HIV.
            (4) The provision of information and education on 
        opportunities to participate in HIV/AIDS-related 
        clinical research.
    (c) Coordination With Other Entities.--A grant awarded 
under subsection (a) may be made only if the applicant provides 
an agreement that includes the following:
            (1) The applicant will coordinate activities under 
        the grant with other providers of health care services 
        under this Act, and under title V of the Social 
        Security Act, including programs promoting the 
        reduction and elimination of risk of HIV/AIDS for 
        youth.
            (2) The applicant will participate in the statewide 
        coordinated statement of need under part B (where it 
        has been initiated by the public health agency 
        responsible for administering grants under part B) and 
        in revisions of such statement.
            (3) The applicant will every 2 years submit to the 
        lead State agency under section 2617(b)(4) audits 
        regarding funds expended in accordance with this title 
        and shall include necessary client-level data to 
        complete unmet need calculations and Statewide 
        coordinated statements of need process.
    (d) Administration; Application.--A grant may only be 
awarded to an entity under subsection (a) if an application for 
the grant is submitted to the Secretary and the application is 
in such form, is made in such manner, and contains such 
agreements, assurances, and information as the Secretary 
determines to be necessary to carry out this section. Such 
application shall include the following:
            (1) Information regarding how the expected 
        expenditures of the grant are related to the planning 
        process for localities funded under part A (including 
        the planning process outlined in section 2602) and for 
        States funded under part B (including the planning 
        process outlined in section 2617(b)).
            (2) A specification of the expected expenditures 
        and how those expenditures will improve overall patient 
        outcomes, as outlined as part of the State plan (under 
        section 2617(b)) or through additional outcome 
        measures.
    (e) Annual Review of Programs; Evaluations.--
            (1) Review regarding access to and participation in 
        programs.--With respect to a grant under subsection (a) 
        for an entity for a fiscal year, the Secretary shall, 
        not later than 180 days after the end of the fiscal 
        year, provide for the conduct and completion of a 
        review of the operation during the year of the program 
        carried out under such subsection by the entity. The 
        purpose of such review shall be the development of 
        recommendations, as appropriate, for improvements in 
        the following:
                    (A) Procedures used by the entity to 
                allocate opportunities and services under 
                subsection (a) among patients of the entity who 
                are women, infants, children, or youth.
                    (B) Other procedures or policies of the 
                entity regarding the participation of such 
                individuals in such program.
            (2) Evaluations.----The Secretary shall, directly 
        or through contracts with public and private entities, 
        provide for evaluations of programs carried out 
        pursuant to subsection (a).
    (f) Administrative Expenses.--
            (1) Limitation.--A grantee may not use more than 10 
        percent of amounts received under a grant awarded under 
        this section for administrative expenses.
            (2) Clinical quality management program.--A grantee 
        under this section shall implement a clinical quality 
        management program to assess the extent to which HIV 
        health services provided to patients under the grant 
        are consistent with the most recent Public Health 
        Service guidelines for the treatment of HIV/AIDS and 
        related opportunistic infection, and as applicable, to 
        develop strategies for ensuring that such services are 
        consistent with the guidelines for improvement in the 
        access to and quality of HIV health services.
    (g) Training and Technical Assistance.--From the amounts 
appropriated under subsection (j) for a fiscal year, the 
Secretary may use not more than 5 percent to provide, directly 
or through contracts with public and private entities (which 
may include grantees under subsection (a)), training and 
technical assistance to assist applicants and grantees under 
subsection (a) in complying with the requirements of this 
section.
    (h) Definitions.--In this section:
            (1) Administrative expenses.--The term 
        ``administrative expenses'' means funds that are to be 
        used by grantees for grant management and monitoring 
        activities, including costs related to any staff or 
        activity unrelated to services or indirect costs.
            (2) Indirect costs.--The term ``indirect costs'' 
        means costs included in a Federally negotiated indirect 
        rate.
            (3) Services.--The term ``services'' means--
                    (A) services that are provided to clients 
                to meet the goals and objectives of the program 
                under this section, including the provision of 
                professional, diagnostic, and therapeutic 
                services by a primary care provider or a 
                referral to and provision of specialty care; 
                and
                    (B) services that sustain program activity 
                and contribute to or help improve services 
                under subparagraph (A).
    (i) Application to Primary Care Services.--Nothing in this 
part shall be construed as requiring funds under this part to 
be used for primary care services when payments are available 
for such services from other sources (including under titles 
XVIII, XIX, and XXI of the Social Security Act).
    (j) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated, $71,800,000 for each of the fiscal years 2007 
through 2009, $75,390,000 for fiscal year 2010, $79,160,000 for 
fiscal year 2011, $83,117,000 for fiscal year 2012, and 
$87,273,000 for fiscal year 2013.

                       PART E--GENERAL PROVISIONS

SEC. 2681. [300FF-81] COORDINATION.

    (a) Requirement.--The Secretary shall ensure that the 
Health Resources and Services Administration, the Centers for 
Disease Control and Prevention, the Substance Abuse and Mental 
Health Services Administration, and the Centers for Medicare & 
Medicaid Services coordinate the planning, funding, and 
implementation of Federal HIV programs (including all minority 
AIDS initiatives of the Public Health Service, including under 
section 2693) to enhance the continuity of care and prevention 
services for individuals with HIV/AIDS or those at risk of such 
disease. The Secretary shall consult with other Federal 
agencies, including the Department of Veterans Affairs, as 
needed and utilize planning information submitted to such 
agencies by the States and entities eligible for assistance 
under this title.
    (b) Report.--The Secretary shall biennially prepare and 
submit to the appropriate committees of the Congress a report 
concerning the coordination efforts at the Federal, State, and 
local levels described in this section, including a description 
of Federal barriers to HIV program integration and a strategy 
for eliminating such barriers and enhancing the continuity of 
care and prevention services for individuals with HIV/AIDS or 
those at risk of such disease.
    (c) Integration by State.--As a condition of receipt of 
funds under this title, a State shall provide assurances to the 
Secretary that health support services funded under this title 
will be integrated with other such services, that programs will 
be coordinated with other available programs (including 
Medicaid), and that the continuity of care and prevention 
services of individuals with HIV/AIDS is enhanced.
    (d) Integration by Local or Private Entities.--As a 
condition of receipt of funds under this title, a local 
government or private nonprofit entity shall provide assurances 
to the Secretary that services funded under this title will be 
integrated with other such services, that programs will be 
coordinated with other available programs (including Medicaid), 
and that the continuity of care and prevention services of 
individuals with HIV is enhanced.

SEC. 2682. [300FF-82] AUDITS.

    (a) In General.--For fiscal year 2009, and each subsequent 
fiscal year, the Secretary may reduce the amounts of grants 
under this title to a State or political subdivision of a State 
for a fiscal year if, with respect to such grants for the 
second preceding fiscal year, the State or subdivision fails to 
prepare audits in accordance with the procedures of section 
7502 of title 31, United States Code. The Secretary shall 
annually select representative samples of such audits, prepare 
summaries of the selected audits, and submit the summaries to 
the Congress.
    (b) Posting on the Internet.--All audits that the Secretary 
receives from the State lead agency under section 2617(b)(4) 
shall be posted, in their entirety, on the Internet website of 
the Health Resources and Services Administration.

SEC. 2683. [300FF-83] PUBLIC HEALTH EMERGENCY.

    (a) In General.--In an emergency area and during an 
emergency period, the Secretary shall have the authority to 
waive such requirements of this title to improve the health and 
safety of those receiving care under this title and the general 
public, except that the Secretary may not expend more than 5 
percent of the funds allocated under this title for sections 
2620 and section 2603(b).
    (b) Emergency Area and Emergency Period.--In this section:
            (1) Emergency area.--The term ``emergency area'' 
        means a geographic area in which there exists--
                    (A) an emergency or disaster declared by 
                the President pursuant to the National 
                Emergencies Act or the Robert T. Stafford 
                Disaster Relief and Emergency Assistance Act; 
                or
                    (B) a public health emergency declared by 
                the Secretary pursuant to section 319.
            (2) Emergency period.--The term ``emergency 
        period'' means the period in which there exists--
                    (A) an emergency or disaster declared by 
                the President pursuant to the National 
                Emergencies Act or the Robert T. Stafford 
                Disaster Relief and Emergency Assistance Act; 
                or
                    (B) a public health emergency declared by 
                the Secretary pursuant to section 319.
    (c) Unobligated Funds.--If funds under a grant under this 
section are not expended for an emergency in the fiscal year in 
which the emergency is declared, such funds shall be returned 
to the Secretary for reallocation under sections 2603(b) and 
2620.

SEC. 2684. [300FF-84] PROHIBITION ON PROMOTION OF CERTAIN ACTIVITIES.

    None of the funds appropriated under this title shall be 
used to fund AIDS programs, or to develop materials, designed 
to promote or encourage, directly, intravenous drug use or 
sexual activity, whether homosexual or heterosexual. Funds 
authorized under this title may be used to provide medical 
treatment and support services for individuals with HIV.

SEC. 2685. [300FF-85] PRIVACY PROTECTIONS.

    (a) In General.--The Secretary shall ensure that any 
information submitted to, or collected by, the Secretary under 
this title excludes any personally identifiable information.
    (b) Definition.--In this section, the term ``personally 
identifiable information'' has the meaning given such term 
under the regulations promulgated under section 264(c) of the 
Health Insurance Portability and Accountability Act of 1996.

SEC. 2686. [300FF-86] GAO REPORT.

    The Comptroller General of the Government Accountability 
Office shall, not less than 1 year after the date of enactment 
of the Ryan White HIV/AIDS Treatment Extension Act of 2009, 
submit to the appropriate committees of Congress a report 
describing Minority AIDS Initiative activities across the 
Department of Health and Human Services, including programs 
under this title and programs at the Centers for Disease 
Control and Prevention, the Substance Abuse and Mental Health 
Services Administration, and other departmental agencies. Such 
report shall include a history of program activities within 
each relevant agency and a description of activities conducted, 
people served and types of grantees funded, and shall collect 
and describe best practices in community outreach and capacity-
building of community based organizations serving the 
communities that are disproportionately affected by HIV/AIDS.

SEC. 2687. [300FF-87] SEVERITY OF NEED INDEX.

    (a) Development of Index.--Not later than September 30, 
2008, the Secretary shall develop and submit to the appropriate 
committees of Congress a severity of need index in accordance 
with subsection (c).
    (b) Definition of Severity of Need Index.--In this section, 
the term ``severity of need index'' means the index of the 
relative needs of individuals within a State or area, as 
identified by a number of different factors, and is a factor or 
set of factors that is multiplied by the number of living HIV/
AIDS cases in a State or area, providing different weights to 
those cases based on needs. Such factors or set of factors may 
be different for different components of the provisions under 
this title.
    (c) Requirements for Secretarial Submission.--When the 
Secretary submits to the appropriate committees of Congress the 
severity of need index under subsection (a), the Secretary 
shall provide the following:
            (1) Methodology for and rationale behind developing 
        the severity of need index, including information 
        related to the field testing of the severity of need 
        index.
            (2) An independent contractor analysis of 
        activities carried out under paragraph (1).
            (3) Information regarding the process by which the 
        Secretary received community input regarding the 
        application and development of the severity of need 
        index.
    (d) Annual Reports.--If the Secretary fails to submit the 
severity of need index under subsection (a) in either of fiscal 
years 2007 or 2008, the Secretary shall prepare and submit to 
the appropriate committees of Congress a report for such fiscal 
year--
            (1) that updates progress toward having client 
        level data;
            (2) that updates the progress toward having a 
        severity of need index, including information related 
        to the methodology and process for obtaining community 
        input; and
            (3) that, as applicable, states whether the 
        Secretary could develop a severity of need index before 
        fiscal year 2009.

SEC. 2688. [300FF-87A] NATIONAL HIV/AIDS TESTING GOAL.

    (a) In General.--Not later than January 1, 2010, the 
Secretary shall establish a national HIV/AIDS testing goal of 
5,000,000 tests for HIV/AIDS annually through federally-
supported HIV/AIDS prevention, treatment, and care programs, 
including programs under this title and other programs 
administered by the Centers for Disease Control and Prevention.
    (b) Annual Report.--Not later than January 1, 2011, and 
annually thereafter, the Secretary, acting through the Director 
of the Centers for Disease Control and Prevention, shall submit 
to Congress a report describing, with regard to the preceding 
12-month reporting period--
            (1) whether the testing goal described in 
        subsection (a) has been met;
            (2) the total number of individuals tested through 
        federally-supported and other HIV/AIDS prevention, 
        treatment, and care programs in each State;
            (3) the number of individuals who--
                    (A) prior to such 12-month period, were 
                unaware of their HIV status; and
                    (B) through federally-supported and other 
                HIV/AIDS prevention, treatment, and care 
                programs, were diagnosed and referred into 
                treatment and care during such period;
            (4) any barriers, including State laws and 
        regulations, that the Secretary determines to be a 
        barrier to meeting the testing goal described in 
        subsection (a);
            (5) the amount of funding the Secretary determines 
        necessary to meet the annual testing goal in the 
        following 12 months and the amount of Federal funding 
        expended to meet the testing goal in the prior 12-month 
        period; and
            (6) the most cost-effective strategies for 
        identifying and diagnosing individuals who were unaware 
        of their HIV status, including voluntary testing with 
        pre-test counseling, routine screening including opt-
        out testing, partner counseling and referral services, 
        and mass media campaigns.
    (c) Review of Program Effectiveness.--Not later than 1 year 
after the date of enactment of this section, the Secretary, in 
consultation with the Director of the Centers for Disease 
Control and Prevention, shall submit a report to Congress based 
on a comprehensive review of each of the programs and 
activities conducted by the Centers for Disease Control and 
Prevention as part of the Domestic HIV/AIDS Prevention 
Activities, including the following:
            (1) The amount of funding provided for each program 
        or activity.
            (2) The primary purpose of each program or 
        activity.
            (3) The annual goals for each program or activity.
            (4) The relative effectiveness of each program or 
        activity with relation to the other programs and 
        activities conducted by the Centers for Disease Control 
        and Prevention, based on the--
                    (A) number of previously undiagnosed 
                individuals with HIV/AIDS made aware of their 
                status and referred into the appropriate 
                treatment;
                    (B) amount of funding provided for each 
                program or activity compared to the number of 
                undiagnosed individuals with HIV/AIDS made 
                aware of their status;
                    (C) program's contribution to the National 
                HIV/AIDS testing goal; and
                    (D) progress made toward the goals 
                described in paragraph (3).
            (5) Recommendations if any to Congress on ways to 
        allocate funding for domestic HIV/AIDS prevention 
        activities and programs in order to achieve the 
        National HIV/AIDS testing goal.
    (d) Coordination With Other Federal Activities.--In 
pursuing the National HIV/AIDS testing goal, the Secretary, 
where appropriate, shall consider and coordinate with other 
national strategies conducted by the Federal Government to 
address HIV/AIDS.

SEC. 2689. [300FF-88] DEFINITIONS.

    For purposes of this title:
            (1) AIDS.--The term ``AIDS'' means acquired immune 
        deficiency syndrome.
            (2) Co-occurring conditions.--The term ``co-
        occurring conditions'' means one or more adverse health 
        conditions in an individual with HIV/AIDS, without 
        regard to whether the individual has AIDS and without 
        regard to whether the conditions arise from HIV.
            (3) Counseling.--The term ``counseling'' means such 
        counseling provided by an individual trained to provide 
        such counseling.
            (4) Family-centered care.--The term ``family-
        centered care'' means the system of services described 
        in this title that is targeted specifically to the 
        special needs of infants, children, women and families. 
        Family-centered care shall be based on a partnership 
        between parents, professionals, and the community 
        designed to ensure an integrated, coordinated, 
        culturally sensitive, and community-based continuum of 
        care for children, women, and families with HIV/AIDS.
            (5) Families with hiv/aids.--The term ``families 
        with HIV/AIDS'' means families in which one or more 
        members have HIV/AIDS.
            (6)  HIV.--The term ``HIV'' means infection with 
        the human immunodeficiency virus.
            (7) HIV/AIDS.--
                    (A) In general.--The term ``HIV/AIDS'' 
                means HIV, and includes AIDS and any condition 
                arising from AIDS.
                    (B) Counting of cases.--The term ``living 
                cases of HIV/AIDS'', with respect to the 
                counting of cases in a geographic area during a 
                period of time, means the sum of--
                            (i) the number of living non-AIDS 
                        cases of HIV in the area; and
                            (ii) the number of living cases of 
                        AIDS in the area.
                    (C) Non-aids cases.--The term ``non-AIDS'', 
                with respect to a case of HIV, means that the 
                individual involved has HIV but does not have 
                AIDS.
            (8) Human immunodeficiency virus.--The term ``human 
        immunodeficiency virus'' means the etiologic agent for 
        AIDS.
            (9) Official poverty line.--The term ``official 
        poverty line'' means the poverty line established by 
        the Director of the Office of Management and Budget and 
        revised by the Secretary in accordance with section 
        673(2) of the Omnibus Budget Reconciliation Act of 
        1981.
            (10) Person.--The term ``person'' includes one or 
        more individuals, governments (including the Federal 
        Government and the governments of the States), 
        governmental agencies, political subdivisions, labor 
        unions, partnerships, associations, corporations, legal 
        representatives, mutual companies, joint-stock 
        companies, trusts, unincorporated organizations, 
        receivers, trustees, and trustees in cases under title 
        11, United States Code.
            (11) State.--
                    (A) In general.--The term ``State'' means 
                each of the 50 States, the District of 
                Columbia, and each of the territories.
                    (B) Territories.--The term ``territory'' 
                means each of American Samoa, Guam, the 
                Commonwealth of Puerto Rico, the Commonwealth 
                of the Northern Mariana Islands, the Virgin 
                Islands, the Republic of the Marshall Islands, 
                the Federated States of Micronesia, and Palau.
            (12) Youth with hiv.--The term ``youth with HIV'' 
        means individuals who are 13 through 24 years old and 
        who have HIV/AIDS.

                   PART F--DEMONSTRATION AND TRAINING

          Subpart I--Special Projects of National Significance

SEC. 2691. [300FF-101] SPECIAL PROJECTS OF NATIONAL SIGNIFICANCE.

    (a) In General.--Of the amount appropriated under each of 
parts A, B, C, and D for each fiscal year, the Secretary shall 
use the greater of $20,000,000 or an amount equal to 3 percent 
of such amount appropriated under each such part, but not to 
exceed $25,000,000, to administer special projects of national 
significance to--
            (1) quickly respond to emerging needs of 
        individuals receiving assistance under this title; and
            (2) to fund special programs to develop a standard 
        electronic client information data system to improve 
        the ability of grantees under this title to report 
        client-level data to the Secretary.
    (b) Grants.--The Secretary shall award grants under 
subsection (a) to entities eligible for funding under parts A, 
B, C, and D based on--
            (1) whether the funding will promote obtaining 
        client level data as it relates to the creation of a 
        severity of need index, including funds to facilitate 
        the purchase and enhance the utilization of qualified 
        health information technology systems;
            (2) demonstrated ability to create and maintain a 
        qualified health information technology system;
            (3) the potential replicability of the proposed 
        activity in other similar localities or nationally;
            (4) the demonstrated reliability of the proposed 
        qualified health information technology system across a 
        variety of providers, geographic regions, and clients; 
        and
            (5) the demonstrated ability to maintain a safe and 
        secure qualified health information system; or
            (6) newly emerging needs of individuals receiving 
        assistance under this title.
    (c) Coordination.--The Secretary may not make a grant under 
this section unless the applicant submits evidence that the 
proposed program is consistent with the statewide coordinated 
statement of need, and the applicant agrees to participate in 
the ongoing revision process of such statement of need.
    (d) Privacy Protection.--The Secretary may not make a grant 
under this section for the development of a qualified health 
information technology system unless the applicant provides 
assurances to the Secretary that the system will, at a minimum, 
comply with the privacy regulations promulgated under section 
264(c) of the Health Insurance Portability and Accountability 
Act of 1996.
    (e) Replication.--The Secretary shall make information 
concerning successful models or programs developed under this 
part available to grantees under this title for the purpose of 
coordination, replication, and integration. To facilitate 
efforts under this subsection, the Secretary may provide for 
peer-based technical assistance for grantees funded under this 
part.

            Subpart II--AIDS Education and Training Centers

SEC. 2692. [300FF-111] HIV/AIDS COMMUNITIES, SCHOOLS, AND CENTERS.

    (a) Schools; Centers.--
            (1) In general.--The Secretary may make grants and 
        enter into contracts to assist public and nonprofit 
        private entities and schools and academic health 
        science centers in meeting the costs of projects--
                    (A) to train health personnel, including 
                practitioners in programs under this title and 
                other community providers, in the diagnosis, 
                treatment, and prevention of HIV/AIDS, 
                including the prevention of the perinatal 
                transmission of the disease, including measures 
                for the prevention and treatment of 
                opportunistic infections, and including (as 
                applicable to the type of health professional 
                involved), prenatal and other gynecological 
                care for women with HIV/AIDS;
                    (B) to train the faculty of schools of, and 
                graduate departments or programs of, medicine, 
                nursing, osteopathic medicine, dentistry, 
                public health, allied health, and mental health 
                practice to teach health professions students 
                to provide for the health care needs of 
                individuals with HIV/AIDS;
                    (C) to develop and disseminate curricula 
                and resource materials relating to the care and 
                treatment of individuals with such disease and 
                the prevention of the disease among individuals 
                who are at risk of contracting the disease; and
                    (D) to develop protocols for the medical 
                care of women with HIV/AIDS, including prenatal 
                and other gynecological care for such women.
            (2) Preference in making grants.--In making grants 
        under paragraph (1), the Secretary shall give 
        preference to qualified projects which will--
                    (A) train, or result in the training of, 
                health professionals who will provide treatment 
                for minority individuals and Native Americans 
                with HIV/AIDS and other individuals who are at 
                high risk of contracting such disease;
                    (B) train, or result in the training of, 
                minority health professionals and minority 
                allied health professionals to provide 
                treatment for individuals with such disease; 
                and
                    (C) train or result in the training of 
                health professionals and allied health 
                professionals to provide treatment for 
                hepatitis B or C co-infected individuals.
            (3) Application.--No grant or contract may be made 
        under paragraph (1) unless an application is submitted 
        to the Secretary in such form, at such time, and 
        containing such information, as the Secretary may 
        prescribe.
    (b) Dental Schools.--
            (1) In general.--
                    (A) Grants.--The Secretary may make grants 
                to dental schools and programs described in 
                subparagraph (B) to assist such schools and 
                programs with respect to oral health care to 
                patients with HIV/AIDS.
                    (B) Eligible applicants.--For purposes of 
                this subsection, the dental schools and 
                programs referred to in this subparagraph are 
                dental schools and programs that were described 
                in section 777(b)(4)(B) as such section was in 
                effect on the day before the date of the 
                enactment of the Health Professions Education 
                Partnerships Act of 1998 (Public Law 105-392) 
                and in addition dental hygiene programs that 
                are accredited by the Commission on Dental 
                Accreditation.
            (2) Application.--Each dental school or program 
        described in section \1\ the section referred to in 
        paragraph (1)(B) may annually submit an application 
        documenting the unreimbursed costs of oral health care 
        provided to patients with HIV/AIDS by that school or 
        hospital during the prior year.
---------------------------------------------------------------------------
    \1\ So in law. See section 402(b)(2) of Public Law 106-345 (114 
Stat. 1349).
---------------------------------------------------------------------------
            (3) Distribution.--The Secretary shall distribute 
        the available funds among all eligible applicants, 
        taking into account the number of patients with HIV/
        AIDS served and the unreimbursed oral health care costs 
        incurred by each institution as compared with the total 
        number of patients served and costs incurred by all 
        eligible applicants.
            (4) Maintenance of effort.--The Secretary shall not 
        make a grant under this subsection if doing so would 
        result in any reduction in State funding allotted for 
        such purposes.
            (5) Community-based care.--The Secretary may make 
        grants to dental schools and programs described in 
        paragraph (1)(B) that partner with community-based 
        dentists to provide oral health care to patients with 
        HIV/AIDS in unserved areas. Such partnerships shall 
        permit the training of dental students and residents 
        and the participation of community dentists as adjunct 
        faculty.
    (c) Authorization of Appropriations.--
            (1) Schools; centers.--For the purpose of awarding 
        grants under subsection (a), there are authorized to be 
        appropriated $34,700,000 for each of the fiscal years 
        2007 through 2009, $36,535,000 for fiscal year 2010, 
        $38,257,000 for fiscal year 2011, $40,170,000 for 
        fiscal year 2012, and $42,178,000 for fiscal year 2013.
            (2) Dental schools.--For the purpose of awarding 
        grants under subsection (b), there are authorized to be 
        appropriated $13,000,000 for each of the fiscal years 
        2007 through 2009, $13,650,000 for fiscal year 2010, 
        $14,333,000 for fiscal year 2011, $15,049,000 for 
        fiscal year 2012, and $15,802,000 for fiscal year 2013.

                 Subpart III--Minority AIDS Initiative

SEC. 2693. [300FF-121] MINORITY AIDS INITIATIVE.

    (a) In General.--For the purpose of carrying out activities 
under this section to evaluate and address the disproportionate 
impact of HIV/AIDS on, and the disparities in access, 
treatment, care, and outcomes for, racial and ethnic minorities 
(including African Americans, Alaska Natives, Latinos, American 
Indians, Asian Americans, Native Hawaiians, and Pacific 
Islanders), there are authorized to be appropriated 
$131,200,000 for fiscal year 2007, $135,100,000 for fiscal year 
2008, $139,100,000 for fiscal year 2009, $146,055,000 for 
fiscal year 2010, $153,358,000 for fiscal year 2011, 
$161,026,000 for fiscal year 2012, and $169,077,000 for fiscal 
year 2013. The Secretary shall develop a formula for the 
awarding of grants under subsections (b)(1)(A) and (b)(1)(B) 
that ensures that funding is provided based on the distribution 
of populations disproportionately impacted by HIV/AIDS.
    (b) Certain Activities.--
            (1) In general.--In carrying out the purpose 
        described in subsection (a), the Secretary shall 
        provide for--
                    (A) emergency assistance under part A;
                    (B) care grants under part B;
                    (C) early intervention services under part 
                C;
                    (D) services through projects for HIV-
                related care under part D; and
                    (E) activities through education and 
                training centers under section 2692.
            (2) Allocations among activities.--Activities under 
        paragraph (1) shall be carried out by the Secretary in 
        accordance with the following:
                    (A) For supplemental grants to improve HIV-
                related health outcomes to reduce existing 
                racial and ethnic health disparities, the 
                Secretary shall, of the amount appropriated 
                under subsection (a) for a fiscal year, reserve 
                the following, as applicable:
                            (i) For fiscal year 2007, 
                        $43,800,000.
                            (ii) For fiscal year 2008, 
                        $45,400,000.
                            (iii) For fiscal year 2009, 
                        $47,100,000.
                            (iv) For fiscal year 2010, 
                        $46,738,000.
                            (v) For fiscal year 2011, 
                        $49,075,000.
                            (vi) For fiscal year 2012, 
                        $51,528,000.
                            (vii) For fiscal year 2013, 
                        $54,105,000.
                    (B) For grants used for supplemental 
                support education and outreach services to 
                increase the number of eligible racial and 
                ethnic minorities who have access to treatment 
                through the program under section 2616 for 
                therapeutics, the Secretary shall, of the 
                amount appropriated for a fiscal year under 
                subsection (a), reserve the following, as 
                applicable:
                            (i) For fiscal year 2007, 
                        $7,000,000.
                            (ii) For fiscal year 2008, 
                        $7,300,000.
                            (iii) For fiscal year 2009, 
                        $7,500,000.
                            (iv) For fiscal year 2010, 
                        $8,763,000.
                            (v) For fiscal year 2011, 
                        $9,202,000.
                            (vi) For fiscal year 2012, 
                        $9,662,000.
                            (vii) For fiscal year 2013, 
                        $10,145,000.
                    (C) For planning grants, capacity-building 
                grants, and services grants to health care 
                providers who have a history of providing 
                culturally and linguistically appropriate care 
                and services to racial and ethnic minorities, 
                the Secretary shall, of the amount appropriated 
                for a fiscal year under subsection (a), reserve 
                the following, as applicable:
                            (i) For fiscal year 2007, 
                        $53,400,000.
                            (ii) For fiscal year 2008, 
                        $55,400,000.
                            (iii) For fiscal year 2009, 
                        $57,400,000.
                            (iv) For fiscal year 2010, 
                        $61,343,000.
                            (v) For fiscal year 2011, 
                        $64,410,000.
                            (vi) For fiscal year 2012, 
                        $67,631,000.
                            (vii) For fiscal year 2013, 
                        $71,012,000.
                    (D) For eliminating racial and ethnic 
                disparities in the delivery of comprehensive, 
                culturally and linguistically appropriate care 
                services for HIV disease for women, infants, 
                children, and youth, the Secretary shall, of 
                the amount appropriated under subsection (a), 
                reserve the following, as applicable:
                            (i) For fiscal year 2010, 
                        $20,448,000.
                            (ii) For fiscal year 2011, 
                        $21,470,000.
                            (iii) For fiscal year 2012, 
                        $22,543,000.
                            (iv) For fiscal year 2013, 
                        $23,671,000.
                    (E) For increasing the training capacity of 
                centers to expand the number of health care 
                professionals with treatment expertise and 
                knowledge about the most appropriate standards 
                of HIV disease-related treatments and medical 
                care for racial and ethnic minority adults, 
                adolescents, and children with HIV disease, the 
                Secretary shall, of the amount appropriated 
                under subsection (a), reserve the following, as 
                applicable:
                            (i) For fiscal year 2010, 
                        $8,763,000.
                            (ii) For fiscal year 2011, 
                        $9,201,000.
                            (iii) For fiscal year 2012, 
                        $9,662,000.
                            (iv) For fiscal year 2013, 
                        $10,144,000.
    (c) Consistency With Prior Program.--With respect to the 
purpose described in subsection (a), the Secretary shall carry 
out this section consistent with the activities carried out 
under this title by the Secretary pursuant to the Departments 
of Labor, Health and Human Services, and Education, and Related 
Agencies Appropriations Act, 2002 (Public Law 107-116).
    (d) Synchronization of Minority AIDS Initiative.--For 
fiscal year 2010 and each subsequent fiscal year, the Secretary 
shall incorporate and synchronize the schedule of application 
submissions and funding availability under this section with 
the schedule of application submissions and funding 
availability under the corresponding provisions of this title 
XXVI as follows:
            (1) The schedule for carrying out subsection 
        (b)(1)(A) shall be the same as the schedule applicable 
        to emergency assistance under part A.
            (2) The schedule for carrying out subsection 
        (b)(1)(B) shall be the same as the schedule applicable 
        to care grants under part B.
            (3) The schedule for carrying out subsection 
        (b)(1)(C) shall be the same as the schedule applicable 
        to grants for early intervention services under part C.
            (4) The schedule for carrying out subsection 
        (b)(1)(D) shall be the same as the schedule applicable 
        to grants for services through projects for HIV-related 
        care under part D.
            (5) The schedule for carrying out subsection 
        (b)(1)(E) shall be the same as the schedule applicable 
        to grants and contracts for activities through 
        education and training centers under section 2692.

    PART G--NOTIFICATION OF POSSIBLE EXPOSURE TO INFECTIOUS DISEASES

SEC. 2695. [300FF-131] INFECTIOUS DISEASES AND CIRCUMSTANCES RELEVANT 
                    TO NOTIFICATION REQUIREMENTS.

    (a) In General.--Not later than 180 days after the date of 
the enactment of this part, the Secretary shall complete the 
development of--
            (1) a list of potentially life-threatening 
        infectious diseases, including emerging infectious 
        diseases, to which emergency response employees may be 
        exposed in responding to emergencies;
            (2) guidelines describing the circumstances in 
        which such employees may be exposed to such diseases, 
        taking into account the conditions under which 
        emergency response is provided; and
            (3) guidelines describing the manner in which 
        medical facilities should make determinations for 
        purposes of section 2695B(d).
    (b) Specification of Airborne Infectious Diseases.--The 
list developed by the Secretary under subsection (a)(1) shall 
include a specification of those infectious diseases on the 
list that are routinely transmitted through airborne or 
aerosolized means.
    (c) Dissemination.--The Secretary shall--
            (1) transmit to State public health officers copies 
        of the list and guidelines developed by the Secretary 
        under subsection (a) with the request that the officers 
        disseminate such copies as appropriate throughout the 
        States; and
            (2) make such copies available to the public.

SEC. 2695A. [300FF-132] ROUTINE NOTIFICATIONS WITH RESPECT TO AIRBORNE 
                    INFECTIOUS DISEASES IN VICTIMS ASSISTED.

    (a) Routine Notification of Designated Officer.--
            (1) Determination by treating facility.--If a 
        victim of an emergency is transported by emergency 
        response employees to a medical facility and the 
        medical facility makes a determination that the victim 
        has an airborne infectious disease, the medical 
        facility shall notify the designated officer of the 
        emergency response employees who transported the victim 
        to the medical facility of the determination.
            (2) Determination by facility ascertaining cause of 
        death.--If a victim of an emergency is transported by 
        emergency response employees to a medical facility and 
        the victim dies at or before reaching the medical 
        facility, the medical facility ascertaining the cause 
        of death shall notify the designated officer of the 
        emergency response employees who transported the victim 
        to the initial medical facility of any determination by 
        the medical facility that the victim had an airborne 
        infectious disease.
    (b) Requirement of Prompt Notification.--With respect to a 
determination described in paragraph (1) or (2) of subsection 
(a), the notification required in each of such paragraphs shall 
be made as soon as is practicable, but not later than 48 hours 
after the determination is made.

SEC. 2695B. [300FF-133] REQUEST FOR NOTIFICATION WITH RESPECT TO 
                    VICTIMS ASSISTED.

    (a) Initiation of Process by Employee.--If an emergency 
response employee believes that the employee may have been 
exposed to an infectious disease by a victim of an emergency 
who was transported to a medical facility as a result of the 
emergency, and if the employee attended, treated, assisted, or 
transported the victim pursuant to the emergency, then the 
designated officer of the employee shall, upon the request of 
the employee, carry out the duties described in subsection (b) 
regarding a determination of whether the employee may have been 
exposed to an infectious disease by the victim.
    (b) Initial Determination by Designated Officer.--The 
duties referred to in subsection (a) are that--
            (1) the designated officer involved collect the 
        facts relating to the circumstances under which, for 
        purposes of subsection (a), the employee involved may 
        have been exposed to an infectious disease; and
            (2) the designated officer evaluate such facts and 
        make a determination of whether, if the victim involved 
        had any infectious disease included on the list issued 
        under paragraph (1) of section 2695(a), the employee 
        would have been exposed to the disease under such 
        facts, as indicated by the guidelines issued under 
        paragraph (2) of such section.
    (c) Submission of Request to Medical Facility.--
            (1) In general.--If a designated officer makes a 
        determination under subsection (b)(2) that an emergency 
        response employee may have been exposed to an 
        infectious disease, the designated officer shall submit 
        to the medical facility to which the victim involved 
        was transported a request for a response under 
        subsection (d) regarding the victim of the emergency 
        involved.
            (2) Form of request.--A request under paragraph (1) 
        shall be in writing and be signed by the designated 
        officer involved, and shall contain a statement of the 
        facts collected pursuant to subsection (b)(1).
    (d) Evaluation and Response Regarding Request to Medical 
Facility.--
            (1) In general.--If a medical facility receives a 
        request under subsection (c), the medical facility 
        shall evaluate the facts submitted in the request and 
        make a determination of whether, on the basis of the 
        medical information possessed by the facility regarding 
        the victim involved, the emergency response employee 
        was exposed to an infectious disease included on the 
        list issued under paragraph (1) of section 2695(a), as 
        indicated by the guidelines issued under paragraph (2) 
        of such section.
            (2) Notification of exposure.--If a medical 
        facility makes a determination under paragraph (1) that 
        the emergency response employee involved has been 
        exposed to an infectious disease, the medical facility 
        shall, in writing, notify the designated officer who 
        submitted the request under subsection (c) of the 
        determination.
            (3) Finding of no exposure.--If a medical facility 
        makes a determination under paragraph (1) that the 
        emergency response employee involved has not been 
        exposed to an infectious disease, the medical facility 
        shall, in writing, inform the designated officer who 
        submitted the request under subsection (c) of the 
        determination.
            (4) Insufficient information.--
                    (A) If a medical facility finds in 
                evaluating facts for purposes of paragraph (1) 
                that the facts are insufficient to make the 
                determination described in such paragraph, the 
                medical facility shall, in writing, inform the 
                designated officer who submitted the request 
                under subsection (c) of the insufficiency of 
                the facts.
                    (B)(i) If a medical facility finds in 
                making a determination under paragraph (1) that 
                the facility possesses no information on 
                whether the victim involved has an infectious 
                disease included on the list under section 
                2695(a), the medical facility shall, in 
                writing, inform the designated officer who 
                submitted the request under subsection (c) of 
                the insufficiency of such medical information.
                    (ii) If after making a response under 
                clause (i) a medical facility determines that 
                the victim involved has an infectious disease, 
                the medical facility shall make the 
                determination described in paragraph (1) and 
                provide the applicable response specified in 
                this subsection.
    (e) Time for Making Response.--After receiving a request 
under subsection (c) (including any such request resubmitted 
under subsection (g)(2)), a medical facility shall make the 
applicable response specified in subsection (d) as soon as is 
practicable, but not later than 48 hours after receiving the 
request.
    (f) Death of Victim of Emergency.--
            (1) Facility ascertaining cause of death.--If a 
        victim described in subsection (a) dies at or before 
        reaching the medical facility involved, and the medical 
        facility receives a request under subsection (c), the 
        medical facility shall provide a copy of the request to 
        the medical facility ascertaining the cause of death of 
        the victim, if such facility is a different medical 
        facility than the facility that received the original 
        request.
            (2) Responsibility of facility.--Upon the receipt 
        of a copy of a request for purposes of paragraph (1), 
        the duties otherwise established in this part regarding 
        medical facilities shall apply to the medical facility 
        ascertaining the cause of death of the victim in the 
        same manner and to the same extent as such duties apply 
        to the medical facility originally receiving the 
        request.
    (g) Assistance of Public Health Officer.--
            (1) Evaluation of response of medical facility 
        regarding insufficient facts.--
                    (A) In the case of a request under 
                subsection (c) to which a medical facility has 
                made the response specified in subsection 
                (d)(4)(A) regarding the insufficiency of facts, 
                the public health officer for the community in 
                which the medical facility is located shall 
                evaluate the request and the response, if the 
                designated officer involved submits such 
                documents to the officer with the request that 
                the officer make such an evaluation.
                    (B) As soon as is practicable after a 
                public health officer receives a request under 
                subparagraph (A), but not later than 48 hours 
                after receipt of the request, the public health 
                officer shall complete the evaluation required 
                in such paragraph and inform the designated 
                officer of the results of the evaluation.
            (2) Findings of evaluation.--
                    (A) If an evaluation under paragraph (1)(A) 
                indicates that the facts provided to the 
                medical facility pursuant to subsection (c) 
                were sufficient for purposes of determinations 
                under subsection (d)(1)--
                            (i) the public health officer 
                        shall, on behalf of the designated 
                        officer involved, resubmit the request 
                        to the medical facility; and
                            (ii) the medical facility shall 
                        provide to the designated officer the 
                        applicable response specified in 
                        subsection (d).
                    (B) If an evaluation under paragraph (1)(A) 
                indicates that the facts provided in the 
                request to the medical facility were 
                insufficient for purposes of determinations 
                specified in subsection (c)--
                            (i) the public health officer shall 
                        provide advice to the designated 
                        officer regarding the collection and 
                        description of appropriate facts; and
                            (ii) if sufficient facts are 
                        obtained by the designated officer--
                                    (I) the public health 
                                officer shall, on behalf of the 
                                designated officer involved, 
                                resubmit the request to the 
                                medical facility; and
                                    (II) the medical facility 
                                shall provide to the designated 
                                officer the appropriate 
                                response under subsection (c).

SEC. 2695C. [300FF-134] PROCEDURES FOR NOTIFICATION OF EXPOSURE.

    (a) Contents of Notification to Officer.--In making a 
notification required under section 2695A or section 
2695B(d)(2), a medical facility shall provide--
            (1) the name of the infectious disease involved; 
        and
            (2) the date on which the victim of the emergency 
        involved was transported by emergency response 
        employees to the medical facility involved.
    (b) Manner of Notification.--If a notification under 
section 2695A or section 2695B(d)(2) is mailed or otherwise 
indirectly made--
            (1) the medical facility sending the notification 
        shall, upon sending the notification, inform the 
        designated officer to whom the notification is sent of 
        the fact that the notification has been sent; and
            (2) such designated officer shall, not later than 
        10 days after being informed by the medical facility 
        that the notification has been sent, inform such 
        medical facility whether the designated officer has 
        received the notification.

SEC. 2695D. [300FF-135] NOTIFICATION OF EMPLOYEE.

    (a) In General.--After receiving a notification for 
purposes of section 2695A or 2695B(d)(2), a designated officer 
of emergency response employees shall, to the extent 
practicable, immediately notify each of such employees who--
            (1) responded to the emergency involved; and
            (2) as indicated by guidelines developed by the 
        Secretary, may have been exposed to an infectious 
        disease.
    (b) Certain Contents of Notification to Employee.--A 
notification under this subsection to an emergency response 
employee shall inform the employee of--
            (1) the fact that the employee may have been 
        exposed to an infectious disease and the name of the 
        disease involved;
            (2) any action by the employee that, as indicated 
        by guidelines developed by the Secretary, is medically 
        appropriate; and
            (3) if medically appropriate under such criteria, 
        the date of such emergency.
    (c) Responses Other Than Notification of Exposure.--After 
receiving a response under paragraph (3) or (4) of subsection 
(d) of section 2695B, or a response under subsection (g)(1) of 
such section, the designated officer for the employee shall, to 
the extent practicable, immediately inform the employee of the 
response.

SEC. 2695E. [300FF-136] SELECTION OF DESIGNATED OFFICERS.

    (a) In General.--For the purposes of receiving 
notifications and responses and making requests under this part 
on behalf of emergency response employees, the public health 
officer of each State shall designate 1 official or officer of 
each employer of emergency response employees in the State.
    (b) Preference in Making Designations.--In making the 
designations required in subsection (a), a public health 
officer shall give preference to individuals who are trained in 
the provision of health care or in the control of infectious 
diseases.

SEC. 2695F. [300FF-137] LIMITATION WITH RESPECT TO DUTIES OF MEDICAL 
                    FACILITIES.

    The duties established in this part for a medical 
facility--
            (1) shall apply only to medical information 
        possessed by the facility during the period in which 
        the facility is treating the victim for conditions 
        arising from the emergency, or during the 60-day period 
        beginning on the date on which the victim is 
        transported by emergency response employees to the 
        facility, whichever period expires first; and
            (2) shall not apply to any extent after the 
        expiration of the 30-day period beginning on the 
        expiration of the applicable period referred to in 
        paragraph (1), except that such duties shall apply with 
        respect to any request under section 2695B(c) received 
        by a medical facility before the expiration of such 30-
        day period.

SEC. 2695G. [300FF-138] MISCELLANEOUS PROVISIONS.

    (a) Liability of Medical Facilities, Designated Officers, 
Public Health Officers, and Governing Entities.--This part may 
not be construed to authorize any cause of action for damages 
or any civil penalty against any medical facility, any 
designated officer, any other public health officer, or any 
governing entity of such facility or officer for failure to 
comply with the duties established in this part.
    (b) Testing.--This part may not, with respect to victims of 
emergencies, be construed to authorize or require a medical 
facility to test any such victim for any infectious disease.
    (c) Confidentiality.--This part may not be construed to 
authorize or require any medical facility, any designated 
officer of emergency response employees, or any such employee, 
to disclose identifying information with respect to a victim of 
an emergency or with respect to an emergency response employee.
    (d) Failure To Provide Emergency Services.--This part may 
not be construed to authorize any emergency response employee 
to fail to respond, or to deny services, to any victim of an 
emergency.
    (e) Notification and Reporting Deadlines.--In any case in 
which the Secretary determines that, wholly or partially as a 
result of a public health emergency that has been determined 
pursuant to section 319(a), individuals or public or private 
entities are unable to comply with the requirements of this 
part, the Secretary may, notwithstanding any other provision of 
law, temporarily suspend, in whole or in part, the requirements 
of this part as the circumstances reasonably require. Before or 
promptly after such a suspension, the Secretary shall notify 
the Congress of such action and publish in the Federal Register 
a notice of the suspension.
    (f) Continued Application of State and Local Law.--Nothing 
in this part shall be construed to limit the application of 
State or local laws that require the provision of data to 
public health authorities.

SEC. 2695H. [300FF-139] INJUNCTIONS REGARDING VIOLATION OF PROHIBITION.

    (a) In General.--The Secretary may, in any court of 
competent jurisdiction, commence a civil action for the purpose 
of obtaining temporary or permanent injunctive relief with 
respect to any violation of this part.
    (b) Facilitation of Information on Violations.--The 
Secretary shall establish an administrative process for 
encouraging emergency response employees to provide information 
to the Secretary regarding violations of this part. As 
appropriate, the Secretary shall investigate alleged such 
violations and seek appropriate injunctive relief.

SEC. 2695I. [300FF-140] APPLICABILITY OF PART.

    This part shall not apply in a State if the chief executive 
officer of the State certifies to the Secretary that the law of 
the State is substantially consistent with this 
part.4/13/2009 12:41:15 PM - f:\Vhlc\041309\041309.022 
Created by: PRGriffi deg.4/13/2009 12:42:28 PM - 
f:\Vhlc\041309\041309.023 Created by: 
PRGriffi deg.ATTORNEY: PMG/FD (June 24, 1999) deg.
    TITLE XXVII--REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE

                    Part A--Group Market Reforms \1\
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    \1\ Effective on September 23, 2010, section 1001(1) of Public Law 
111-148 provides for an amendment to strike the part A heading and 
insert the following: ``PART A--INDIVIDUAL AND GROUP MARKET REFORMS''.

    [Note: For a version of law of part A, as amended by 1001, 
1201, and 1563 (relating to conforming amendments--originally 
designated as section 1562 and redesignated as section 1563 by 
section 10107(b)(1)) of Public Law 111-148, see note set out in 
---------------------------------------------------------------------------
italic typeface that appears after section 2723 below.]

     Subpart 1--Portability, Access, and Renewability Requirements

SEC. 2701. [300GG] INCREASED PORTABILITY THROUGH LIMITATION ON 
                    PREEXISTING CONDITION EXCLUSIONS.

    (a) Limitation on Preexisting Condition Exclusion Period; 
Crediting for Periods of Previous Coverage.--Subject to 
subsection (d), a group health plan, and a health insurance 
issuer offering group health insurance coverage, may, with 
respect to a participant or beneficiary, impose a preexisting 
condition exclusion only if--
            (1) such exclusion relates to a condition (whether 
        physical or mental), regardless of the cause of the 
        condition, for which medical advice, diagnosis, care, 
        or treatment was recommended or received within the 6-
        month period ending on the enrollment date;
            (2) such exclusion extends for a period of not more 
        than 12 months (or 18 months in the case of a late 
        enrollee) after the enrollment date; and
            (3) the period of any such preexisting condition 
        exclusion is reduced by the aggregate of the periods of 
        creditable coverage (if any, as defined in subsection 
        (c)(1)) applicable to the participant or beneficiary as 
        of the enrollment date.
    (b) Definitions.--For purposes of this part--
            (1) Preexisting condition exclusion.--
                    (A) In general.--The term ``preexisting 
                condition exclusion'' means, with respect to 
                coverage, a limitation or exclusion of benefits 
                relating to a condition based on the fact that 
                the condition was present before the date of 
                enrollment for such coverage, whether or not 
                any medical advice, diagnosis, care, or 
                treatment was recommended or received before 
                such date.
                    (B) Treatment of genetic information.--
                Genetic information shall not be treated as a 
                condition described in subsection (a)(1) in the 
                absence of a diagnosis of the condition related 
                to such information.
            (2) Enrollment date.--The term ``enrollment date'' 
        means, with respect to an individual covered under a 
        group health plan or health insurance coverage, the 
        date of enrollment of the individual in the plan or 
        coverage or, if earlier, the first day of the waiting 
        period for such enrollment.
            (3) Late enrollee.--The term ``late enrollee'' 
        means, with respect to coverage under a group health 
        plan, a participant or beneficiary who enrolls under 
        the plan other than during--
                    (A) the first period in which the 
                individual is eligible to enroll under the 
                plan, or
                    (B) a special enrollment period under 
                subsection (f).
            (4) Waiting period.--The term ``waiting period'' 
        means, with respect to a group health plan and an 
        individual who is a potential participant or 
        beneficiary in the plan, the period that must pass with 
        respect to the individual before the individual is 
        eligible to be covered for benefits under the terms of 
        the plan.
    (c) Rules Relating to Crediting Previous Coverage.--
            (1) Creditable coverage defined.--For purposes of 
        this title, the term ``creditable coverage'' means, 
        with respect to an individual, coverage of the 
        individual under any of the following:
                    (A) A group health plan.
                    (B) Health insurance coverage.
                    (C) Part A or part B of title XVIII of the 
                Social Security Act.
                    (D) Title XIX of the Social Security Act, 
                other than coverage consisting solely of 
                benefits under section 1928.
                    (E) Chapter 55 of title 10, United States 
                Code.
                    (F) A medical care program of the Indian 
                Health Service or of a tribal organization.
                    (G) A State health benefits risk pool.
                    (H) A health plan offered under chapter 89 
                of 
                title 5, United States Code.
                    (I) A public health plan (as defined in 
                regulations).
                    (J) A health benefit plan under section 
                5(e) of the Peace Corps Act (22 U.S.C. 
                2504(e)).
        Such term does not include coverage consisting solely 
        of coverage of excepted benefits (as defined in section 
        2791(c)).
            (2) Not counting periods before significant breaks 
        in coverage.--
                    (A) In general.--A period of creditable 
                coverage shall not be counted, with respect to 
                enrollment of an individual under a group 
                health plan, if, after such period and before 
                the enrollment date, there was a 63-day period 
                during all of which the individual was not 
                covered under any creditable coverage.
                    (B) Waiting period not treated as a break 
                in coverage.--For purposes of subparagraph (A) 
                and subsection (d)(4), any period that an 
                individual is in a waiting period for any 
                coverage under a group health plan (or for 
                group health insurance coverage) or is in an 
                affiliation period (as defined in subsection 
                (g)(2)) shall not be taken into account in 
                determining the continuous period under 
                subparagraph (A).
                    (C) TAA-eligible individuals.--In the case 
                of plan years beginning before February 13, 
                2011--
                            (i) TAA pre-certification period 
                        rule.--In the case of a TAA-eligible 
                        individual, the period beginning on the 
                        date the individual has a TAA-related 
                        loss of coverage and ending on the date 
                        that is 7 days after the date of the 
                        issuance by the Secretary (or by any 
                        person or entity designated by the 
                        Secretary) of a qualified health 
                        insurance costs credit eligibility 
                        certificate for such individual for 
                        purposes of section 7527 of the 
                        Internal Revenue Code of 1986 shall not 
                        be taken into account in determining 
                        the continuous period under 
                        subparagraph (A).
                            (ii) Definitions.--The terms ``TAA-
                        eligible individual'' and ``TAA-related 
                        loss of coverage'' have the meanings 
                        given such terms in section 2205(b)(4).
            (3) Method of crediting coverage.--
                    (A) Standard method.--Except as otherwise 
                provided under subparagraph (B), for purposes 
                of applying subsection (a)(3), a group health 
                plan, and a health insurance issuer offering 
                group health insurance coverage, shall count a 
                period of creditable coverage without regard to 
                the specific benefits covered during the 
                period.
                    (B) Election of alternative method.--A 
                group health plan, or a health insurance issuer 
                offering group health insurance, may elect to 
                apply subsection (a)(3) based on coverage of 
                benefits within each of several classes or 
                categories of benefits specified in regulations 
                rather than as provided under subparagraph (A). 
                Such election shall be made on a uniform basis 
                for all participants and beneficiaries. Under 
                such election a group health plan or issuer 
                shall count a period of creditable coverage 
                with respect to any class or category of 
                benefits if any level of benefits is covered 
                within such class or category.
                    (C) Plan notice.--In the case of an 
                election with respect to a group health plan 
                under subparagraph (B) (whether or not health 
                insurance coverage is provided in connection 
                with such plan), the plan shall--
                            (i) prominently state in any 
                        disclosure statements concerning the 
                        plan, and state to each enrollee at the 
                        time of enrollment under the plan, that 
                        the plan has made such election, and
                            (ii) include in such statements a 
                        description of the effect of this 
                        election.
                    (D) Issuer notice.--In the case of an 
                election under subparagraph (B) with respect to 
                health insurance coverage offered by an issuer 
                in the small or large group market, the 
                issuer--
                            (i) shall prominently state in any 
                        disclosure statements concerning the 
                        coverage, and to each employer at the 
                        time of the offer or sale of the 
                        coverage, that the issuer has made such 
                        election, and
                            (ii) shall include in such 
                        statements a description of the effect 
                        of such election.
            (4) Establishment of period.--Periods of creditable 
        coverage with respect to an individual shall be 
        established through presentation of certifications 
        described in subsection (e) or in such other manner as 
        may be specified in regulations.
    (d) Exceptions.--
            (1) Exclusion not applicable to certain newborns.--
        Subject to paragraph (4), a group health plan, and a 
        health insurance issuer offering group health insurance 
        coverage, may not impose any preexisting condition 
        exclusion in the case of an individual who, as of the 
        last day of the 30-day period beginning with the date 
        of birth, is covered under creditable coverage.
            (2) Exclusion not applicable to certain adopted 
        children.--Subject to paragraph (4), a group health 
        plan, and a health insurance issuer offering group 
        health insurance coverage, may not impose any 
        preexisting condition exclusion in the case of a child 
        who is adopted or placed for adoption before attaining 
        18 years of age and who, as of the last day of the 30-
        day period beginning on the date of the adoption or 
        placement for adoption, is covered under creditable 
        coverage. The previous sentence shall not apply to 
        coverage before the date of such adoption or placement 
        for adoption.
            (3) Exclusion not applicable to pregnancy.--A group 
        health plan, and health insurance issuer offering group 
        health insurance coverage, may not impose any 
        preexisting condition exclusion relating to pregnancy 
        as a preexisting condition.
            (4) Loss if break in coverage.--Paragraphs (1) and 
        (2) shall no longer apply to an individual after the 
        end of the first 63-day period during all of which the 
        individual was not covered under any creditable 
        coverage.
    (e) Certifications and Disclosure of Coverage.--
            (1) Requirement for certification of period of 
        creditable coverage.--
                    (A) In general.--A group health plan, and a 
                health insurance issuer offering group health 
                insurance coverage, shall provide the 
                certification described in subparagraph (B)--
                            (i) at the time an individual 
                        ceases to be covered under the plan or 
                        otherwise becomes covered under a COBRA 
                        continuation provision,
                            (ii) in the case of an individual 
                        becoming covered under such a 
                        provision, at the time the individual 
                        ceases to be covered under such 
                        provision, and
                            (iii) on the request on behalf of 
                        an individual made not later than 24 
                        months after the date of cessation of 
                        the coverage described in clause (i) or 
                        (ii), whichever is later.
                The certification under clause (i) may be 
                provided, to the extent practicable, at a time 
                consistent with notices required under any 
                applicable COBRA continuation provision.
                    (B) Certification.--The certification 
                described in this subparagraph is a written 
                certification of--
                            (i) the period of creditable 
                        coverage of the individual under such 
                        plan and the coverage (if any) under 
                        such COBRA continuation provision, and
                            (ii) the waiting period (if any) 
                        (and affiliation period, if applicable) 
                        imposed with respect to the individual 
                        for any coverage under such plan.
                    (C) Issuer compliance.--To the extent that 
                medical care under a group health plan consists 
                of group health insurance coverage, the plan is 
                deemed to have satisfied the certification 
                requirement under this paragraph if the health 
                insurance issuer offering the coverage provides 
                for such certification in accordance with this 
                paragraph.
            (2) Disclosure of information on previous 
        benefits.--In the case of an election described in 
        subsection (c)(3)(B) by a group health plan or health 
        insurance issuer, if the plan or issuer enrolls an 
        individual for coverage under the plan and the 
        individual provides a certification of coverage of the 
        individual under paragraph (1)--
                    (A) upon request of such plan or issuer, 
                the entity which issued the certification 
                provided by the individual shall promptly 
                disclose to such requesting plan or issuer 
                information on coverage of classes and 
                categories of health benefits available under 
                such entity's plan or coverage, and
                    (B) such entity may charge the requesting 
                plan or issuer for the reasonable cost of 
                disclosing such information.
            (3) Regulations.--The Secretary shall establish 
        rules to prevent an entity's failure to provide 
        information under paragraph (1) or (2) with respect to 
        previous coverage of an individual from adversely 
        affecting any subsequent coverage of the individual 
        under another group health plan or health insurance 
        coverage.
    (f) Special Enrollment Periods.--
            (1) Individuals losing other coverage.--A group 
        health plan, and a health insurance issuer offering 
        group health insurance coverage in connection with a 
        group health plan, shall permit an employee who is 
        eligible, but not enrolled, for coverage under the 
        terms of the plan (or a dependent of such an employee 
        if the dependent is eligible, but not enrolled, for 
        coverage under such terms) to enroll for coverage under 
        the terms of the plan if each of the following 
        conditions is met:
                    (A) The employee or dependent was covered 
                under a group health plan or had health 
                insurance coverage at the time coverage was 
                previously offered to the employee or 
                dependent.
                    (B) The employee stated in writing at such 
                time that coverage under a group health plan or 
                health insurance coverage was the reason for 
                declining enrollment, but only if the plan 
                sponsor or issuer (if applicable) required such 
                a statement at such time and provided the 
                employee with notice of such requirement (and 
                the consequences of such requirement) at such 
                time.
                    (C) The employee's or dependent's coverage 
                described in subparagraph (A)--
                            (i) was under a COBRA continuation 
                        provision and the coverage under such 
                        provision was 
                        exhausted; or
                            (ii) was not under such a provision 
                        and either the coverage was terminated 
                        as a result of loss of eligibility for 
                        the coverage (including as a result of 
                        legal separation, divorce, death, 
                        termination of employment, or reduction 
                        in the number of hours of employment) 
                        or employer contributions toward such 
                        coverage were terminated.
                    (D) Under the terms of the plan, the 
                employee requests such enrollment not later 
                than 30 days after the date of exhaustion of 
                coverage described in subparagraph (C)(i) or 
                termination of coverage or employer 
                contribution described in subparagraph (C)(ii).
            (2) For dependent beneficiaries.--
                    (A) In general.--If--
                            (i) a group health plan makes 
                        coverage available with respect to a 
                        dependent of an individual,
                            (ii) the individual is a 
                        participant under the plan (or has met 
                        any waiting period applicable to 
                        becoming a participant under the plan 
                        and is eligible to be enrolled under 
                        the plan but for a failure to enroll 
                        during a previous enrollment period), 
                        and
                            (iii) a person becomes such a 
                        dependent of the individual through 
                        marriage, birth, or adoption or 
                        placement for adoption,
                the group health plan shall provide for a 
                dependent special enrollment period described 
                in subparagraph (B) during which the person 
                (or, if not otherwise enrolled, the individual) 
                may be enrolled under the plan as a dependent 
                of the individual, and in the case of the birth 
                or adoption of a child, the spouse of the 
                individual may be enrolled as a dependent of 
                the individual if such spouse is otherwise 
                eligible for coverage.
                    (B) Dependent special enrollment period.--A 
                dependent special enrollment period under this 
                subparagraph shall be a period of not less than 
                30 days and shall begin on the later of--
                            (i) the date dependent coverage is 
                        made 
                        available, or
                            (ii) the date of the marriage, 
                        birth, or adoption or placement for 
                        adoption (as the case may be) described 
                        in subparagraph (A)(iii).
                    (C) No waiting period.--If an individual 
                seeks to enroll a dependent during the first 30 
                days of such a dependent special enrollment 
                period, the coverage of the dependent shall 
                become effective--
                            (i) in the case of marriage, not 
                        later than the first day of the first 
                        month beginning after the date the 
                        completed request for enrollment is 
                        received;
                            (ii) in the case of a dependent's 
                        birth, as of the date of such birth; or
                            (iii) in the case of a dependent's 
                        adoption or placement for adoption, the 
                        date of such adoption or placement for 
                        adoption.
            (3) Special rules for application in case of 
        medicaid and chip.--
                    (A) In general.--A group health plan, and a 
                health insurance issuer offering group health 
                insurance coverage in connection with a group 
                health plan, shall permit an employee who is 
                eligible, but not enrolled, for coverage under 
                the terms of the plan (or a dependent of such 
                an employee if the dependent is eligible, but 
                not enrolled, for coverage under such terms) to 
                enroll for coverage under the terms of the plan 
                if either of the following conditions is met:
                            (i) Termination of medicaid or chip 
                        coverage.--The employee or dependent is 
                        covered under a Medicaid plan under 
                        title XIX of the Social Security Act or 
                        under a State child health plan under 
                        title XXI of such Act and coverage of 
                        the employee or dependent under such a 
                        plan is terminated as a result of loss 
                        of eligibility for such coverage and 
                        the employee requests coverage under 
                        the group health plan (or health 
                        insurance coverage) not later than 60 
                        days after the date of termination of 
                        such coverage.
                            (ii) Eligibility for employment 
                        assistance under medicaid or chip.--The 
                        employee or dependent becomes eligible 
                        for assistance, with respect to 
                        coverage under the group health plan or 
                        health insurance coverage, under such 
                        Medicaid plan or State child health 
                        plan (including under any waiver or 
                        demonstration project conducted under 
                        or in relation to such a plan), if the 
                        employee requests coverage under the 
                        group health plan or health insurance 
                        coverage not later than 60 days after 
                        the date the employee or dependent is 
                        determined to be eligible for such 
                        assistance.
                    (B) Coordination with medicaid and chip.--
                            (i) Outreach to employees regarding 
                        availability of medicaid and chip 
                        coverage.--
                                    (I) In general.--Each 
                                employer that maintains a group 
                                health plan in a State that 
                                provides medical assistance 
                                under a State Medicaid plan 
                                under title XIX of the Social 
                                Security Act, or child health 
                                assistance under a State child 
                                health plan under title XXI of 
                                such Act, in the form of 
                                premium assistance for the 
                                purchase of coverage under a 
                                group health plan, shall 
                                provide to each employee a 
                                written notice informing the 
                                employee of potential 
                                opportunities then currently 
                                available in the State in which 
                                the employee resides for 
                                premium assistance under such 
                                plans for health coverage of 
                                the employee or the employee's 
                                dependents. For purposes of 
                                compliance with this subclause, 
                                the employer may use any State-
                                specific model notice developed 
                                in accordance with section 
                                701(f)(3)(B)(i)(II) of the 
                                Employee Retirement Income 
                                Security Act of 1974 (29 U.S.C. 
                                1181(f)(3)(B)(i)(II)).
                                    (II) Option to provide 
                                concurrent with provision of 
                                plan materials to employee.--An 
                                employer may provide the model 
                                notice applicable to the State 
                                in which an employee resides 
                                concurrent with the furnishing 
                                of materials notifying the 
                                employee of health plan 
                                eligibility, concurrent with 
                                materials provided to the 
                                employee in connection with an 
                                open season or election process 
                                conducted under the plan, or 
                                concurrent with the furnishing 
                                of the summary plan description 
                                as provided in section 104(b) 
                                of the Employee Retirement 
                                Income Security Act of 1974.
                            (ii) Disclosure about group health 
                        plan benefits to states for medicaid 
                        and chip eligible individuals.--In the 
                        case of an enrollee in a group health 
                        plan who is covered under a Medicaid 
                        plan of a State under title XIX of the 
                        Social Security Act or under a State 
                        child health plan under title XXI of 
                        such Act, the plan administrator of the 
                        group health plan shall disclose to the 
                        State, upon request, information about 
                        the benefits available under the group 
                        health plan in sufficient specificity, 
                        as determined under regulations of the 
                        Secretary of Health and Human Services 
                        in consultation with the Secretary that 
                        require use of the model coverage 
                        coordination disclosure form developed 
                        under section 311(b)(1)(C) of the 
                        Children's Health Insurance 
                        Reauthorization Act of 2009, so as to 
                        permit the State to make a 
                        determination (under paragraph (2)(B), 
                        (3), or (10) of section 2105(c) of the 
                        Social Security Act or otherwise) 
                        concerning the cost-effectiveness of 
                        the State providing medical or child 
                        health assistance through premium 
                        assistance for the purchase of coverage 
                        under such group health plan and in 
                        order for the State to provide 
                        supplemental benefits required under 
                        paragraph (10)(E) of such section or 
                        other authority.
    (g) Use of Affiliation Period by HMOs as Alternative to 
Preexisting Condition Exclusion.--
            (1) In general.--A health maintenance organization 
        which offers health insurance coverage in connection 
        with a group health plan and which does not impose any 
        preexisting condition exclusion allowed under 
        subsection (a) with respect to any particular coverage 
        option may impose an affiliation period for such 
        coverage option, but only if--
                    (A) such period is applied uniformly 
                without regard to any health status-related 
                factors; and
                    (B) such period does not exceed 2 months 
                (or 3 months in the case of a late enrollee).
            (2) Affiliation period.--
                    (A) Defined.--For purposes of this title, 
                the term ``affiliation period'' means a period 
                which, under the terms of the health insurance 
                coverage offered by the health maintenance 
                organization, must expire before the health 
                insurance coverage becomes effective. The 
                organization is not required to provide health 
                care services or benefits during such period 
                and no premium shall be charged to the 
                participant or beneficiary for any coverage 
                during the period.
                    (B) Beginning.--Such period shall begin on 
                the enrollment date.
                    (C) Runs concurrently with waiting 
                periods.--An affiliation period under a plan 
                shall run concurrently with any waiting period 
                under the plan.
            (3) Alternative methods.--A health maintenance 
        organization described in paragraph (1) may use 
        alternative methods, from those described in such 
        paragraph, to address adverse selection as approved by 
        the State insurance commissioner or official or 
        officials designated by the State to enforce the 
        requirements of this part for the State involved with 
        respect to such issuer.

SEC. 2702. \1\ [300GG-1] PROHIBITING DISCRIMINATION AGAINST INDIVIDUAL 
                    PARTICIPANTS AND BENEFICIARIES BASED ON HEALTH 
                    STATUS.
---------------------------------------------------------------------------

    \1\ Effective September 23, 2010, section 1001(5) of Public Law 
111-148 amends part A of title XXVII by inserting after section 2702 a 
new subpart II. For version of law, see note set out in italic typeface 
that appears after section 2702.
---------------------------------------------------------------------------
    (a) In Eligibility To Enroll.--
            (1) In general.--Subject to paragraph (2), a group 
        health plan, and a health insurance issuer offering 
        group health insurance coverage in connection with a 
        group health plan, may not establish rules for 
        eligibility (including continued eligibility) of any 
        individual to enroll under the terms of the plan based 
        on any of the following health status-related factors 
        in relation to the individual or a dependent of the 
        individual:
                    (A) Health status.
                    (B) Medical condition (including both 
                physical and mental illnesses).
                    (C) Claims experience.
                    (D) Receipt of health care.
                    (E) Medical history.
                    (F) Genetic information.
                    (G) Evidence of insurability (including 
                conditions arising out of acts of domestic 
                violence).
                    (H) Disability.
            (2) No application to benefits or exclusions.--To 
        the extent consistent with section 701, paragraph (1) 
        shall not be construed--
                    (A) to require a group health plan, or 
                group health insurance coverage, to provide 
                particular benefits other than those provided 
                under the terms of such plan or coverage, or
                    (B) to prevent such a plan or coverage from 
                establishing limitations or restrictions on the 
                amount, level, extent, or nature of the 
                benefits or coverage for similarly situated 
                individuals enrolled in the plan or coverage.
            (3) Construction.--For purposes of paragraph (1), 
        rules for eligibility to enroll under a plan include 
        rules defining any applicable waiting periods for such 
        enrollment.
    (b) In Premium Contributions.--
            (1) In general.--A group health plan, and a health 
        insurance issuer offering health insurance coverage in 
        connection with a group health plan, may not require 
        any individual (as a condition of enrollment or 
        continued enrollment under the plan) to pay a premium 
        or contribution which is greater than such premium or 
        contribution for a similarly situated individual 
        enrolled in the plan on the basis of any health status-
        related factor in relation to the individual or to an 
        individual enrolled under the plan as a dependent of 
        the individual.
            (2) Construction.--Nothing in paragraph (1) shall 
        be construed--
                    (A) to restrict the amount that an employer 
                may be charged for coverage under a group 
                health plan except as provided in paragraph 
                (3); or
                    (B) to prevent a group health plan, and a 
                health insurance issuer offering group health 
                insurance coverage, from establishing premium 
                discounts or rebates or modifying otherwise 
                applicable copayments or deductibles in return 
                for adherence to programs of health promotion 
                and disease prevention.
            (3) No group-based discrimination on basis of 
        genetic information.--
                    (A) In general.--For purposes of this 
                section, a group health plan, and health 
                insurance issuer offering group health 
                insurance coverage in connection with a group 
                health plan, may not adjust premium or 
                contribution amounts for the group covered 
                under such plan on the basis of genetic 
                information.
                    (B) Rule of construction.--Nothing in 
                subparagraph (A) or in paragraphs (1) and (2) 
                of subsection (d) shall be construed to limit 
                the ability of a health insurance issuer 
                offering health insurance coverage in 
                connection with a group health plan to increase 
                the premium for an employer based on the 
                manifestation of a disease or disorder of an 
                individual who is enrolled in the plan. In such 
                case, the manifestation of a disease or 
                disorder in one individual cannot also be used 
                as genetic information about other group 
                members and to further increase the premium for 
                the employer.
    (c) Genetic Testing.--
            (1) Limitation on requesting or requiring genetic 
        testing.--A group health plan, and a health insurance 
        issuer offering health insurance coverage in connection 
        with a group health plan, shall not request or require 
        an individual or a family member of such individual to 
        undergo a genetic test.
            (2) Rule of construction.--Paragraph (1) shall not 
        be construed to limit the authority of a health care 
        professional who is providing health care services to 
        an individual to request that such individual undergo a 
        genetic test.
            (3) Rule of construction regarding payment.--
                    (A) In general.--Nothing in paragraph (1) 
                shall be construed to preclude a group health 
                plan, or a health insurance issuer offering 
                health insurance coverage in connection with a 
                group health plan, from obtaining and using the 
                results of a genetic test in making a 
                determination regarding payment (as such term 
                is defined for the purposes of applying the 
                regulations promulgated by the Secretary under 
                part C of title XI of the Social Security Act 
                and section 264 of the Health Insurance 
                Portability and Accountability Act of 1996, as 
                may be revised from time to time) consistent 
                with subsection (a).
                    (B) Limitation.--For purposes of 
                subparagraph (A), a group health plan, or a 
                health insurance issuer offering health 
                insurance coverage in connection with a group 
                health plan, may request only the minimum 
                amount of information necessary to accomplish 
                the intended purpose.
            (4) Research exception.--Notwithstanding paragraph 
        (1), a group health plan, or a health insurance issuer 
        offering health insurance coverage in connection with a 
        group health plan, may request, but not require, that a 
        participant or beneficiary undergo a genetic test if 
        each of the following conditions is met:
                    (A) The request is made pursuant to 
                research that complies with part 46 of title 
                45, Code of Federal Regulations, or equivalent 
                Federal regulations, and any applicable State 
                or local law or regulations for the protection 
                of human subjects in research.
                    (B) The plan or issuer clearly indicates to 
                each participant or beneficiary, or in the case 
                of a minor child, to the legal guardian of such 
                beneficiary, to whom the request is made that--
                            (i) compliance with the request is 
                        voluntary; and
                            (ii) non-compliance will have no 
                        effect on enrollment status or premium 
                        or contribution amounts.
                    (C) No genetic information collected or 
                acquired under this paragraph shall be used for 
                underwriting purposes.
                    (D) The plan or issuer notifies the 
                Secretary in writing that the plan or issuer is 
                conducting activities pursuant to the exception 
                provided for under this paragraph, including a 
                description of the activities conducted.
                    (E) The plan or issuer complies with such 
                other conditions as the Secretary may by 
                regulation require for activities conducted 
                under this paragraph.
    (d) Prohibition on Collection of Genetic Information.--
            (1) In general.--A group health plan, and a health 
        insurance issuer offering health insurance coverage in 
        connection with a group health plan, shall not request, 
        require, or purchase genetic information for 
        underwriting purposes (as defined in section 2791).
            (2) Prohibition on collection of genetic 
        information prior to enrollment.--A group health plan, 
        and a health insurance issuer offering health insurance 
        coverage in connection with a group health plan, shall 
        not request, require, or purchase genetic information 
        with respect to any individual prior to such 
        individual's enrollment under the plan or coverage in 
        connection with such enrollment.
            (3) Incidental collection.--If a group health plan, 
        or a health insurance issuer offering health insurance 
        coverage in connection with a group health plan, 
        obtains genetic information incidental to the 
        requesting, requiring, or purchasing of other 
        information concerning any individual, such request, 
        requirement, or purchase shall not be considered a 
        violation of paragraph (2) if such request, 
        requirement, or purchase is not in violation of 
        paragraph (1).
    (e) Application to All Plans.--The provisions of 
subsections (a)(1)(F), (b)(3), (c) , and (d) and subsection 
(b)(1) and section 2701 with respect to genetic information, 
shall apply to group health plans and health insurance issuers 
without regard to section 2721(a).
    (f) Genetic Information of a Fetus or Embryo.--Any 
reference in this part to genetic information concerning an 
individual or family member of an individual shall--
            (1) with respect to such an individual or family 
        member of an individual who is a pregnant woman, 
        include genetic information of any fetus carried by 
        such pregnant woman; and
            (2) with respect to an individual or family member 
        utilizing an assisted reproductive technology, include 
        genetic information of any embryo legally held by the 
        individual or family member.

======================================================================

    [Note: Effective September 23, 2010, section 1001(5) of 
Public Law 111-148 provides for an amendment to add after 
section 2702 a new subpart II. Part A of this title is 
extensively amended by inserting new sections and renumbering 
existing sections throughout by such Public Law, which 
amendments have different effective dates. Subpart II of part A 
reads as follows:]

                     Subpart II--Improving Coverage

SEC. 2711. [300GG-11] NO LIFETIME OR ANNUAL LIMITS.

    (a) Prohibition.--
            (1) In general.--A group health plan and a health 
        insurance issuer offering group or individual health 
        insurance coverage may not establish--
                    (A) lifetime limits on the dollar value of 
                benefits for any participant or beneficiary; or
                    (B) except as provided in paragraph (2), 
                annual limits on the dollar value of benefits 
                for any participant or beneficiary.
            (2) Annual limits prior to 2014.--With respect to 
        plan years beginning prior to January 1, 2014, a group 
        health plan and a health insurance issuer offering 
        group or individual health insurance coverage may only 
        establish a restricted annual limit on the dollar value 
        of benefits for any participant or beneficiary with 
        respect to the scope of benefits that are essential 
        health benefits under section 1302(b) of the Patient 
        Protection and Affordable Care Act, as determined by 
        the Secretary. In defining the term ``restricted annual 
        limit'' for purposes of the preceding sentence, the 
        Secretary shall ensure that access to needed services 
        is made available with a minimal impact on premiums.
    (b) Per Beneficiary Limits.--Subsection (a) shall not be 
construed to prevent a group health plan or health insurance 
coverage from placing annual or lifetime per beneficiary limits 
on specific covered benefits that are not essential health 
benefits under section 1302(b) of the Patient Protection and 
Affordable Care Act, to the extent that such limits are 
otherwise permitted under Federal or State law.

SEC. 2712. [300GG-12] PROHIBITION ON RESCISSIONS.

    A group health plan and a health insurance issuer offering 
group or individual health insurance coverage shall not rescind 
such plan or coverage with respect to an enrollee once the 
enrollee is covered under such plan or coverage involved, 
except that this section shall not apply to a covered 
individual who has performed an act or practice that 
constitutes fraud or makes an intentional misrepresentation of 
material fact as prohibited by the terms of the plan or 
coverage. Such plan or coverage may not be cancelled except 
with prior notice to the enrollee, and only as permitted under 
section 2702(c) or 2742(b).

SEC. 2713. [300GG-13] COVERAGE OF PREVENTIVE HEALTH SERVICES.

    (a) In General.--A group health plan and a health insurance 
issuer offering group or individual health insurance coverage 
shall, at a minimum provide coverage for and shall not impose 
any cost sharing requirements for--
            (1) evidence-based items or services that have in 
        effect a rating of ``A'' or ``B'' in the current 
        recommendations of the United States Preventive 
        Services Task Force;
            (2) immunizations that have in effect a 
        recommendation from the Advisory Committee on 
        Immunization Practices of the Centers for Disease 
        Control and Prevention with respect to the individual 
        involved; and
            (3) with respect to infants, children, and 
        adolescents, evidence-informed preventive care and 
        screenings provided for in the comprehensive guidelines 
        supported by the Health Resources and Services 
        Administration.
            (4) with respect to women, such additional 
        preventive care and screenings not described in 
        paragraph (1) as provided for in comprehensive 
        guidelines supported by the Health Resources and 
        Services Administration for purposes of this paragraph.
            (5) for the purposes of this Act, and for the 
        purposes of any other provision of law, the current 
        recommendations of the United States Preventive Service 
        Task Force regarding breast cancer screening, 
        mammography, and prevention shall be considered the 
        most current other than those issued in or around 
        November 2009.
Nothing in this subsection shall be construed to prohibit a 
plan or issuer from providing coverage for services in addition 
to those recommended by United States Preventive Services Task 
Force or to deny coverage for services that are not recommended 
by such Task Force.
    (b) Interval.--
            (1) In general.--The Secretary shall establish a 
        minimum interval between the date on which a 
        recommendation described in subsection (a)(1) or (a)(2) 
        or a guideline under subsection (a)(3) is issued and 
        the plan year with respect to which the requirement 
        described in subsection (a) is effective with respect 
        to the service described in such recommendation or 
        guideline.
            (2) Minimum.--The interval described in paragraph 
        (1) shall not be less than 1 year.
    (c) Value-based Insurance Design.--The Secretary may 
develop guidelines to permit a group health plan and a health 
insurance issuer offering group or individual health insurance 
coverage to utilize value-based insurance designs.

SEC. 2714. [300GG-14] EXTENSION OF DEPENDENT COVERAGE.

    (a) In General.--A group health plan and a health insurance 
issuer offering group or individual health insurance coverage 
that provides dependent coverage of children shall continue to 
make such coverage available for an adult child until the child 
turns 26 years of age. Nothing in this section shall require a 
health plan or a health insurance issuer described in the 
preceding sentence to make coverage available for a child of a 
child receiving dependent coverage.
    (b) Regulations.--The Secretary shall promulgate 
regulations to define the dependents to which coverage shall be 
made available under subsection (a).
    (c) Rule of Construction.--Nothing in this section shall be 
construed to modify the definition of ``dependent'' as used in 
the Internal Revenue Code of 1986 with respect to the tax 
treatment of the cost of coverage.

SEC. 2715. [300GG-15] DEVELOPMENT AND UTILIZATION OF UNIFORM 
                    EXPLANATION OF COVERAGE DOCUMENTS AND STANDARDIZED 
                    DEFINITIONS.

    (a) In General.--Not later than 12 months after the date of 
enactment of the Patient Protection and Affordable Care Act, 
the Secretary shall develop standards for use by a group health 
plan and a health insurance issuer offering group or individual 
health insurance coverage, in compiling and providing to 
applicants, enrollees, and policyholders or certificate holders 
a summary of benefits and coverage explanation that accurately 
describes the benefits and coverage under the applicable plan 
or coverage. In developing such standards, the Secretary shall 
consult with the National Association of Insurance 
Commissioners (referred to in this section as the ``NAIC''), a 
working group composed of representatives of health insurance-
related consumer advocacy organizations, health insurance 
issuers, health care professionals, patient advocates including 
those representing individuals with limited English 
proficiency, and other qualified individuals.
    (b) Requirements.--The standards for the summary of 
benefits and coverage developed under subsection (a) shall 
provide for the following:
            (1) Appearance.--The standards shall ensure that 
        the summary of benefits and coverage is presented in a 
        uniform format that does not exceed 4 pages in length 
        and does not include print smaller than 12-point font.
            (2) Language.--The standards shall ensure that the 
        summary is presented in a culturally and linguistically 
        appropriate manner and utilizes terminology 
        understandable by the average plan enrollee.
            (3) Contents.--The standards shall ensure that the 
        summary of benefits and coverage includes--
                    (A) uniform definitions of standard 
                insurance terms and medical terms (consistent 
                with subsection (g)) so that consumers may 
                compare health insurance coverage and 
                understand the terms of coverage (or exception 
                to such coverage);
                    (B) a description of the coverage, 
                including cost sharing for--
                            (i) each of the categories of the 
                        essential health benefits described in 
                        subparagraphs (A) through (J) of 
                        section 1302(b)(1) of the Patient 
                        Protection and Affordable Care Act; and
                            (ii) other benefits, as identified 
                        by the Secretary;
                    (C) the exceptions, reductions, and 
                limitations on coverage;
                    (D) the cost-sharing provisions, including 
                deductible, coinsurance, and co-payment 
                obligations;
                    (E) the renewability and continuation of 
                coverage provisions;
                    (F) a coverage facts label that includes 
                examples to illustrate common benefits 
                scenarios, including pregnancy and serious or 
                chronic medical conditions and related cost 
                sharing, such scenarios to be based on 
                recognized clinical practice guidelines;
                    (G) a statement of whether the plan or 
                coverage--
                            (i) provides minimum essential 
                        coverage (as defined under section 
                        5000A(f) of the Internal Revenue Code 
                        1986); and
                            (ii) ensures that the plan or 
                        coverage share of the total allowed 
                        costs of benefits provided under the 
                        plan or coverage is not less than 60 
                        percent of such costs;
                    (H) a statement that the outline is a 
                summary of the policy or certificate and that 
                the coverage document itself should be 
                consulted to determine the governing 
                contractual provisions; and
                    (I) a contact number for the consumer to 
                call with additional questions and an Internet 
                web address where a copy of the actual 
                individual coverage policy or group certificate 
                of coverage can be reviewed and obtained.
    (c) Periodic Review and Updating.--The Secretary shall 
periodically review and update, as appropriate, the standards 
developed under this section.
    (d) Requirement To Provide.--
            (1) In general.--Not later than 24 months after the 
        date of enactment of the Patient Protection and 
        Affordable Care Act, each entity described in paragraph 
        (3) shall provide, prior to any enrollment restriction, 
        a summary of benefits and coverage explanation pursuant 
           to the standards developed by the Secretary under 
        subsection (a) to--
                    (A) an applicant at the time of 
                application;
                    (B) an enrollee prior to the time of 
                enrollment or reenrollment, as applicable; and
                    (C) a policyholder or certificate holder at 
                the time of issuance of the policy or delivery 
                of the certificate.
            (2) Compliance.--An entity described in paragraph 
        (3) is deemed to be in compliance with this section if 
        the summary of benefits and coverage described in 
        subsection (a) is provided in paper or electronic form.
            (3) Entities in general.--An entity described in 
        this paragraph is--
                    (A) a health insurance issuer (including a 
                group health plan that is not a self-insured 
                plan) offering health insurance coverage within 
                the United States; or
                    (B) in the case of a self-insured group 
                health plan, the plan sponsor or designated 
                administrator of the plan (as such terms are 
                defined in section 3(16) of the Employee 
                Retirement Income Security Act of 1974).
            (4) Notice of modifications.--If a group health 
        plan or health insurance issuer makes any material 
        modification in any of the terms of the plan or 
        coverage involved (as defined for purposes of section 
        102 of the Employee Retirement Income Security Act of 
        1974) that is not reflected in the most recently 
        provided summary of benefits and coverage, the plan or 
        issuer shall provide notice of such modification to 
        enrollees not later than 60 days prior to the date on 
        which such modification will become effective.
    (e) Preemption.--The standards developed under subsection 
(a) shall preempt any related State standards that require a 
summary of benefits and coverage that provides less information 
to consumers than that required to be provided under this 
section, as determined by the Secretary.
    (f) Failure To Provide.--An entity described in subsection 
(d)(3) that willfully fails to provide the information required 
under this section shall be subject to a fine of not more than 
$1,000 for each such failure. Such failure with respect to each 
enrollee shall constitute a separate offense for purposes of 
this subsection.
    (g) Development of Standard Definitions.--
            (1) In general.--The Secretary shall, by 
        regulation, provide for the development of standards 
        for the definitions of terms used in health insurance 
        coverage, including the insurance-related terms 
        described in paragraph (2) and the medical terms 
        described in paragraph (3).
            (2) Insurance-related terms.--The insurance-related 
        terms described in this paragraph are premium, 
        deductible, co-insurance, co-payment, out-of-pocket 
        limit, preferred provider, non-preferred provider, out-
        of-network co-payments, UCR (usual, customary and 
        reasonable) fees, excluded services, grievance and 
        appeals, and such other terms as the Secretary 
        determines are important to define so that consumers 
        may compare health insurance coverage and understand 
        the terms of their coverage.
            (3) Medical terms.--The medical terms described in 
        this paragraph are hospitalization, hospital outpatient 
        care, emergency room care, physician services, 
        prescription drug coverage, durable medical equipment, 
        home health care, skilled nursing care, rehabilitation 
        services, hospice services, emergency medical 
        transportation, and such other terms as the Secretary 
        determines are important to define so that consumers 
        may compare the medical benefits offered by health 
        insurance and understand the extent of those medical 
        benefits (or exceptions to those benefits).

SEC. 2715A. [300GG-15A] PROVISION OF ADDITIONAL INFORMATION.

    A group health plan and a health insurance issuer offering 
group or individual health insurance coverage shall comply with 
the provisions of section 1311(e)(3) of the Patient Protection 
and Affordable Care Act, except that a plan or coverage that is 
not offered through an Exchange shall only be required to 
submit the information required to the Secretary and the State 
insurance commissioner, and make such information available to 
the public.

SEC. 2716. [300GG-16] PROHIBITION ON DISCRIMINATION IN FAVOR OF HIGHLY 
                    COMPENSATED INDIVIDUALS.

    (a) In General.--A group health plan (other than a self-
insured plan) shall satisfy the requirements of section 
105(h)(2) of the Internal Revenue Code of 1986 (relating to 
prohibition on discrimination in favor of highly compensated 
individuals).
    (b) Rules and Definitions.--For purposes of this section--
            (1) Certain rules to apply.--Rules similar to the 
        rules contained in paragraphs (3), (4), and (8) of 
        section 105(h) of such Code shall apply.
            (2) Highly compensated individual.--The term 
        ``highly compensated individual'' has the meaning given 
        such term by section 105(h)(5) of such Code.

SEC. 2717. [300GG-17] ENSURING THE QUALITY OF CARE.

    (a) Quality Reporting.--
            (1) In general.--Not later than 2 years after the 
        date of enactment of the Patient Protection and 
        Affordable Care Act, the Secretary, in consultation 
        with experts in health care quality and stakeholders, 
        shall develop reporting requirements for use by a group 
        health plan, and a health insurance issuer offering 
        group or individual health insurance coverage, with 
        respect to plan or coverage benefits and health care 
        provider reimbursement structures that--
                    (A) improve health outcomes through the 
                implementation of activities such as quality 
                reporting, effective case management, care 
                coordination, chronic disease management, and 
                medication and care compliance initiatives, 
                including through the use of the medical homes 
                model as defined for purposes of section 3602 
                of the Patient Protection and Affordable Care 
                Act, for treatment or services under the plan 
                or coverage;
                    (B) implement activities to prevent 
                hospital readmissions through a comprehensive 
                program for hospital discharge that includes 
                patient-centered education and counseling, 
                comprehensive discharge planning, and post 
                discharge reinforcement by an appropriate 
                health care professional;
                    (C) implement activities to improve patient 
                safety and reduce medical errors through the 
                appropriate use of best clinical practices, 
                evidence based medicine, and health information 
                technology under the plan or coverage; and
                    (D) implement wellness and health promotion 
                activities.
            (2) Reporting requirements.--
                    (A) In general.--A group health plan and a 
                health insurance issuer offering group or 
                individual health insurance coverage shall 
                annually submit to the Secretary, and to 
                enrollees under the plan or coverage, a report 
                on whether the benefits under the plan or 
                coverage satisfy the elements described in 
                subparagraphs (A) through (D) of paragraph (1).
                    (B) Timing of reports.--A report under 
                subparagraph (A) shall be made available to an 
                enrollee under the plan or coverage during each 
                open enrollment period.
                    (C) Availability of reports.--The Secretary 
                shall make reports submitted under subparagraph 
                (A) available to the public through an Internet 
                website.
                    (D) Penalties.--In developing the reporting 
                requirements under paragraph (1), the Secretary 
                may develop and impose appropriate penalties 
                for non-compliance with such requirements.
                    (E) Exceptions.--In developing the 
                reporting requirements under paragraph (1), the 
                Secretary may provide for exceptions to such 
                requirements for group health plans and health 
                insurance issuers that substantially meet the 
                goals of this section.
    (b) Wellness and Prevention Programs.--For purposes of 
subsection (a)(1)(D), wellness and health promotion activities 
may include personalized wellness and prevention services, 
which are coordinated, maintained or delivered by a health care 
provider, a wellness and prevention plan manager, or a health, 
wellness or prevention services organization that conducts 
health risk assessments or offers ongoing face-to-face, 
telephonic or web-based intervention efforts for each of the 
program's participants, and which may include the following 
wellness and prevention efforts:
            (1) Smoking cessation.
            (2) Weight management.
            (3) Stress management.
            (4) Physical fitness.
            (5) Nutrition.
            (6) Heart disease prevention.
            (7) Healthy lifestyle support.
            (8) Diabetes prevention.
    (c) Protection of Second Amendment Gun Rights.--
            (1) Wellness and prevention programs.--A wellness 
        and health promotion activity implemented under 
        subsection (a)(1)(D) may not require the disclosure or 
        collection of any information relating to--
                    (A) the presence or storage of a lawfully-
                possessed firearm or ammunition in the 
                residence or on the property of an individual; 
                or
                    (B) the lawful use, possession, or storage 
                of a firearm or ammunition by an individual.
            (2) Limitation on data collection.--None of the 
        authorities provided to the Secretary under the Patient 
        Protection and Affordable Care Act or an amendment made 
        by that Act shall be construed to authorize or may be 
        used for the collection of any information relating 
        to--
                    (A) the lawful ownership or possession of a 
                firearm or ammunition;
                    (B) the lawful use of a firearm or 
                ammunition; or
                    (C) the lawful storage of a firearm or 
                ammunition.
            (3) Limitation on databases or data banks.--None of 
        the authorities provided to the Secretary under the 
        Patient Protection and Affordable Care Act or an 
        amendment made by that Act shall be construed to 
        authorize or may be used to maintain records of 
        individual ownership or possession of a firearm or 
        ammunition.
            (4) Limitation on determination of premium rates or 
        eligibility for health insurance.--A premium rate may 
        not be increased, health insurance coverage may not be 
        denied, and a discount, rebate, or reward offered for 
        participation in a wellness program may not be reduced 
        or withheld under any health benefit plan issued 
        pursuant to or in accordance with the Patient 
        Protection and Affordable Care Act or an amendment made 
        by that Act on the basis of, or on reliance upon--
                    (A) the lawful ownership or possession of a 
                firearm or ammunition; or
                    (B) the lawful use or storage of a firearm 
                or ammunition.
            (5) Limitation on data collection requirements for 
        individuals.--No individual shall be required to 
        disclose any information under any data collection 
        activity authorized under the Patient Protection and 
        Affordable Care Act or an amendment made by that Act 
        relating to--
                    (A) the lawful ownership or possession of a 
                firearm or ammunition; or
                    (B) the lawful use, possession, or storage 
                of a firearm or ammunition.
    (d) Regulations.--Not later than 2 years after the date of 
enactment of the Patient Protection and Affordable Care Act, 
the Secretary shall promulgate regulations that provide 
criteria for determining whether a reimbursement structure is 
described in subsection (a).
    (e) Study and Report.--Not later than 180 days after the 
date on which regulations are promulgated under subsection (c), 
the Government Accountability Office shall review such 
regulations and conduct a study and submit to the Committee on 
Health, Education, Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the House of 
Representatives a report regarding the impact the activities 
under this section have had on the quality and cost of health 
care.

SEC. 2718. [300GG-18] BRINGING DOWN THE COST OF HEALTH CARE COVERAGE.

    (a) Clear Accounting for Costs.--A health insurance issuer 
offering group or individual health insurance coverage 
(including a grandfathered health plan) shall, with respect to 
each plan year, submit to the Secretary a report concerning the 
ratio of the incurred loss (or incurred claims) plus the loss 
adjustment expense (or change in contract reserves) to earned 
premiums. Such report shall include the percentage of total 
premium revenue, after accounting for collections or receipts 
for risk adjustment and risk corridors and payments of 
reinsurance, that such coverage expends--
            (1) on reimbursement for clinical services provided 
        to enrollees under such coverage;
            (2) for activities that improve health care 
        quality; and
            (3) on all other non-claims costs, including an 
        explanation of the nature of such costs, and excluding 
        Federal and State taxes and licensing or regulatory 
        fees.
The Secretary shall make reports received under this section 
available to the public on the Internet website of the 
Department of Health and Human Services.
    (b) Ensuring That Consumers Receive Value for Their Premium 
Payments.--
            (1) Requirement to provide value for premium 
        payments.--
                    (A) Requirement.--Beginning not later than 
                January 1, 2011, a health insurance issuer 
                offering group or individual health insurance 
                coverage (including a grandfathered health 
                plan) shall, with respect to each plan year, 
                provide an annual rebate to each enrollee under 
                such coverage, on a pro rata basis, if the 
                ratio of the amount of premium revenue expended 
                by the issuer on costs described in paragraphs 
                (1) and (2) of subsection (a) to the total 
                amount of premium revenue (excluding Federal 
                and State taxes and licensing or regulatory 
                fees and after accounting for payments or 
                receipts for risk adjustment, risk corridors, 
                and reinsurance under sections 1341, 1342, and 
                1343 of the Patient Protection and Affordable 
                Care Act) for the plan year (except as provided 
                in subparagraph (B)(ii)), is less than--
                            (i) with respect to a health 
                        insurance issuer offering coverage in 
                        the large group market, 85 percent, or 
                        such higher percentage as a State may 
                        by regulation determine; or
                            (ii) with respect to a health 
                        insurance issuer offering coverage in 
                        the small group market or in the 
                        individual market, 80 percent, or such 
                        higher percentage as a State may by 
                        regulation determine, except that the 
                        Secretary may adjust such percentage 
                        with respect to a State if the 
                        Secretary determines that the 
                        application of such 80 percent may 
                        destabilize the individual market in 
                        such State.
                    (B) Rebate amount.--
                            (i) Calculation of amount.--The 
                        total amount of an annual rebate 
                        required under this paragraph shall be 
                        in an amount equal to the product of--
                                    (I) the amount by which the 
                                percentage described in clause 
                                (i) or (ii) of subparagraph (A) 
                                exceeds the ratio described in 
                                such subparagraph; and
                                    (II) the total amount of 
                                premium revenue (excluding 
                                Federal and State taxes and 
                                licensing or regulatory fees 
                                and after accounting for 
                                payments or receipts for risk 
                                adjustment, risk corridors, and 
                                reinsurance under sections 
                                1341, 1342, and 1343 of the 
                                Patient Protection and 
                                Affordable Care Act) for such 
                                plan year.
                            (ii) Calculation based on average 
                        ratio.--Beginning on January 1, 2014, 
                        the determination made under 
                        subparagraph (A) for the year involved 
                        shall be based on the averages of the 
                        premiums expended on the costs 
                        described in such subparagraph and 
                        total premium revenue for each of the 
                        previous 3 years for the plan.
            (2) Consideration in setting percentages.--In 
        determining the percentages under paragraph (1), a 
        State shall seek to ensure adequate participation by 
        health insurance issuers, competition in the health 
        insurance market in the State, and value for consumers 
        so that premiums are used for clinical services and 
        quality improvements.
            (3) Enforcement.--The Secretary shall promulgate 
        regulations for enforcing the provisions of this 
        section and may provide for appropriate penalties.
    (c) Definitions.--Not later than December 31, 2010, and 
subject to the certification of the Secretary, the National 
Association of Insurance Commissioners shall establish uniform 
definitions of the activities reported under subsection (a) and 
standardized methodologies for calculating measures of such 
activities, including definitions of which activities, and in 
what regard such activities, constitute activities described in 
subsection (a)(2). Such methodologies shall be designed to take 
into account the special circumstances of smaller plans, 
different types of plans, and newer plans.
    (d) Adjustments.--The Secretary may adjust the rates 
described in subsection (b) if the Secretary determines 
appropriate on account of the volatility of the individual 
market due to the establishment of State Exchanges.
    (e) Standard Hospital Charges.--Each hospital operating 
within the United States shall for each year establish (and 
update) and make public (in accordance with guidelines 
developed by the Secretary) a list of the hospital's standard 
charges for items and services provided by the hospital, 
including for diagnosis-related groups established under 
section 1886(d)(4) of the Social Security Act.

SEC. 2719. [300GG-19] APPEALS PROCESS.

    (a) Internal Claims Appeals.--
            (1) In general.--A group health plan and a health 
        insurance issuer offering group or individual health 
        insurance coverage shall implement an effective appeals 
        process for appeals of coverage determinations and 
        claims, under which the plan or issuer shall, at a 
        minimum--
                    (A) have in effect an internal claims 
                appeal process;
                    (B) provide notice to enrollees, in a 
                culturally and linguistically appropriate 
                manner, of available internal and external 
                appeals processes, and the availability of any 
                applicable office of health insurance consumer 
                assistance or ombudsman established under 
                section 2793 to assist such enrollees with the 
                appeals processes; and
                    (C) allow an enrollee to review their file, 
                to present evidence and testimony as part of 
                the appeals process, and to receive continued 
                coverage pending the outcome of the appeals 
                process.
            (2) Established processes.--To comply with 
        paragraph (1)--
                    (A) a group health plan and a health 
                insurance issuer offering group health coverage 
                shall provide an internal claims and appeals 
                process that initially incorporates the claims 
                and appeals procedures (including urgent 
                claims) set forth at section 2560.503-1 of 
                title 29, Code of Federal Regulations, as 
                published on November 21, 2000 (65 Fed. Reg. 
                70256), and shall update such process in 
                accordance with any standards established by 
                the Secretary of Labor for such plans and 
                issuers; and
                    (B) a health insurance issuer offering 
                individual health coverage, and any other 
                issuer not subject to subparagraph (A), shall 
                provide an internal claims and appeals process 
                that initially incorporates the claims and 
                appeals procedures set forth under applicable 
                law (as in existence on the date of enactment 
                of this section), and shall update such process 
                in accordance with any standards established by 
                the Secretary of Health and Human Services for 
                such issuers.
    (b) External Review.--A group health plan and a health 
insurance issuer offering group or individual health insurance 
coverage--
            (1) shall comply with the applicable State external 
        review process for such plans and issuers that, at a 
        minimum, includes the consumer protections set forth in 
        the Uniform External Review Model Act promulgated by 
        the National Association of Insurance Commissioners and 
        is binding on such plans; or
            (2) shall implement an effective external review 
        process that meets minimum standards established by the 
        Secretary through guidance and that is similar to the 
        process described under paragraph (1)--
                    (A) if the applicable State has not 
                established an external review process that 
                meets the requirements of paragraph (1); or
                    (B) if the plan is a self-insured plan that 
                is not subject to State insurance regulation 
                (including a State law that establishes an 
                external review process described in paragraph 
                (1)).
    (c) Secretary Authority.--The Secretary may deem the 
external review process of a group health plan or health 
insurance issuer, in operation as of the date of enactment of 
this section, to be in compliance with the applicable process 
established under subsection (b), as determined appropriate by 
the Secretary.

SEC. 2719A. [300GG-19A] PATIENT PROTECTIONS.

    (a) Choice of Health Care Professional.--If a group health 
plan, or a health insurance issuer offering group or individual 
health insurance coverage, requires or provides for designation 
by a participant, beneficiary, or enrollee of a participating 
primary care provider, then the plan or issuer shall permit 
each participant, beneficiary, and enrollee to designate any 
participating primary care provider who is available to accept 
such individual.
    (b) Coverage of Emergency Services.--
            (1) In general.--If a group health plan, or a 
        health insurance issuer offering group or individual 
        health insurance issuer, provides or covers any 
        benefits with respect to services in an emergency 
        department of a hospital, the plan or issuer shall 
        cover emergency services (as defined in paragraph 
        (2)(B))--
                    (A) without the need for any prior 
                authorization determination;
                    (B) whether the health care provider 
                furnishing such services is a participating 
                provider with respect to such services;
                    (C) in a manner so that, if such services 
                are provided to a participant, beneficiary, or 
                enrollee--
                            (i) by a nonparticipating health 
                        care provider with or without prior 
                        authorization; or
                            (ii)(I) such services will be 
                        provided without imposing any 
                        requirement under the plan for prior 
                        authorization of services or any 
                        limitation on coverage where the 
                        provider of services does not have a 
                        contractual relationship with the plan 
                        for the providing of services that is 
                        more restrictive than the requirements 
                        or limitations that apply to emergency 
                        department services received from 
                        providers who do have such a 
                        contractual relationship with the plan; 
                        and
                            (II) if such services are provided 
                        out-of-network, the cost-sharing 
                        requirement (expressed as a copayment 
                        amount or coinsurance rate) is the same 
                        requirement that would apply if such 
                        services were provided in-network;
                    (D) without regard to any other term or 
                condition of such coverage (other than 
                exclusion or coordination of benefits, or an 
                affiliation or waiting period, permitted under 
                section 2701 of this Act, section 701 of the 
                Employee Retirement Income Security Act of 
                1974, or section 9801 of the Internal Revenue 
                Code of 1986, and other than applicable cost-
                sharing).
            (2) Definitions.--In this subsection:
                    (A) Emergency medical condition.--The term 
                ``emergency medical condition'' means a medical 
                condition manifesting itself by acute symptoms 
                of sufficient severity (including severe pain) 
                such that a prudent layperson, who possesses an 
                average knowledge of health and medicine, could 
                reasonably expect the absence of immediate 
                medical attention to result in a condition 
                described in clause (i), (ii), or (iii) of 
                section 1867(e)(1)(A) of the Social Security 
                Act.
                    (B) Emergency services.--The term 
                ``emergency services'' means, with respect to 
                an emergency medical condition--
                            (i) a medical screening examination 
                        (as required under section 1867 of the 
                        Social Security Act) that is within the 
                        capability of the emergency department 
                        of a hospital, including ancillary 
                        services routinely available to the 
                        emergency department to evaluate such 
                        emergency medical condition, and
                            (ii) within the capabilities of the 
                        staff and facilities available at the 
                        hospital, such further medical 
                        examination and treatment as are 
                        required under section 1867 of such Act 
                        to stabilize the patient.
                    (C) Stabilize.--The term ``to stabilize'', 
                with respect to an emergency medical condition 
                (as defined in subparagraph (A)), has the 
                meaning give in section 1867(e)(3) of the 
                Social Security Act (42 U.S.C. 1395dd(e)(3)).
    (c) Access to Pediatric Care.--
            (1) Pediatric care.--In the case of a person who 
        has a child who is a participant, beneficiary, or 
        enrollee under a group health plan, or health insurance 
        coverage offered by a health insurance issuer in the 
        group or individual market, if the plan or issuer 
        requires or provides for the designation of a 
        participating primary care provider for the child, the 
        plan or issuer shall permit such person to designate a 
        physician (allopathic or osteopathic) who specializes 
        in pediatrics as the child's primary care provider if 
        such provider participates in the network of the plan 
        or issuer.
            (2) Construction.--Nothing in paragraph (1) shall 
        be construed to waive any exclusions of coverage under 
        the terms and conditions of the plan or health 
        insurance coverage with respect to coverage of 
        pediatric care.
    (d) Patient Access to Obstetrical and Gynecological Care.--
            (1) General rights.--
                    (A) Direct access.--A group health plan, or 
                health insurance issuer offering group or 
                individual health insurance coverage, described 
                in paragraph (2) may not require authorization 
                or referral by the plan, issuer, or any person 
                (including a primary care provider described in 
                paragraph (2)(B)) in the case of a female 
                participant, beneficiary, or enrollee who seeks 
                coverage for obstetrical or gynecological care 
                provided by a participating health care 
                professional who specializes in obstetrics or 
                gynecology. Such professional shall agree to 
                otherwise adhere to such plan's or issuer's 
                policies and procedures, including procedures 
                regarding referrals and obtaining prior 
                authorization and providing services pursuant 
                to a treatment plan (if any) approved by the 
                plan or issuer.
                    (B) Obstetrical and gynecological care.--A 
                group health plan or health insurance issuer 
                described in paragraph (2) shall treat the 
                provision of obstetrical and gynecological 
                care, and the ordering of related obstetrical 
                and gynecological items and services, pursuant 
                to the direct access described under 
                subparagraph (A), by a participating health 
                care professional who specializes in obstetrics 
                or gynecology as the authorization of the 
                primary care provider.
            (2) Application of paragraph.--A group health plan, 
        or health insurance issuer offering group or individual 
        health insurance coverage, described in this paragraph 
        is a group health plan or coverage that--
                    (A) provides coverage for obstetric or 
                gynecologic care; and
                    (B) requires the designation by a 
                participant, beneficiary, or enrollee of a 
                participating primary care provider.
            (3) Construction.--Nothing in paragraph (1) shall 
        be construed to--
                    (A) waive any exclusions of coverage under 
                the terms and conditions of the plan or health 
                insurance coverage with respect to coverage of 
                obstetrical or gynecological care; or
                    (B) preclude the group health plan or 
                health insurance issuer involved from requiring 
                that the obstetrical or gynecological provider 
                notify the primary care health care 
                professional or the plan or issuer of treatment 
                decisions.

=======================================================================


                   Subpart 2--Other Requirements \1\
---------------------------------------------------------------------------

    \1\ Effective January 1, 2014, the probable intent of Congress is 
to strike both the subpart designation and heading, but the amendment 
by section 1563 (relating to conforming amendments--originally 
designated as section 1562 and redesignated as section 1563 by section 
10107(b)(1)) of Public Law 111-148, strikes only the ``second 
heading''.
---------------------------------------------------------------------------

SEC. 2704. [300GG-4] STANDARDS RELATING TO BENEFITS FOR MOTHERS AND 
                    NEWBORNS. \2\
---------------------------------------------------------------------------

    \2\ Effective September 23, 2010, section 1001(2) of Public Law 
111-148 provides for an amendment to redesignate sections 2704 through 
2707 as sections 2725 through 2728.
---------------------------------------------------------------------------
    (a) Requirements for Minimum Hospital Stay Following 
Birth.--
            (1) In general.--A group health plan, and a health 
        insurance issuer offering group health insurance 
        coverage, may not--
                    (A) except as provided in paragraph (2)--
                            (i) restrict benefits for any 
                        hospital length of stay in connection 
                        with childbirth for the mother or 
                        newborn child, following a normal 
                        vaginal delivery, to less than 48 
                        hours, or
                            (ii) restrict benefits for any 
                        hospital length of stay in connection 
                        with childbirth for the mother or 
                        newborn child, following a cesarean 
                        section, to less than 96 hours, or
                    (B) require that a provider obtain 
                authorization from the plan or the issuer for 
                prescribing any length of stay required under 
                subparagraph (A) (without regard to paragraph 
                (2)).
            (2) Exception.--Paragraph (1)(A) shall not apply in 
        connection with any group health plan or health 
        insurance issuer in any case in which the decision to 
        discharge the mother or her newborn child prior to the 
        expiration of the minimum length of stay otherwise 
        required under paragraph (1)(A) is made by an attending 
        provider in consultation with the mother.
    (b) Prohibitions.--A group health plan, and a health 
insurance issuer offering group health insurance coverage in 
connection with a group health plan, may not--
            (1) deny to the mother or her newborn child 
        eligibility, or continued eligibility, to enroll or to 
        renew coverage under the terms of the plan, solely for 
        the purpose of avoiding the requirements of this 
        section;
            (2) provide monetary payments or rebates to mothers 
        to encourage such mothers to accept less than the 
        minimum protections available under this section;
            (3) penalize or otherwise reduce or limit the 
        reimbursement of an attending provider because such 
        provider provided care to an individual participant or 
        beneficiary in accordance with this section;
            (4) provide incentives (monetary or otherwise) to 
        an attending provider to induce such provider to 
        provide care to an individual participant or 
        beneficiary in a manner inconsistent with this section; 
        or
            (5) subject to subsection (c)(3), restrict benefits 
        for any portion of a period within a hospital length of 
        stay required under subsection (a) in a manner which is 
        less favorable than the benefits provided for any 
        preceding portion of such stay.
    (c) Rules of Construction.--
            (1) Nothing in this section shall be construed to 
        require a mother who is a participant or beneficiary--
                    (A) to give birth in a hospital; or
                    (B) to stay in the hospital for a fixed 
                period of time following the birth of her 
                child.
            (2) This section shall not apply with respect to 
        any group health plan, or any group health insurance 
        coverage offered by a health insurance issuer, which 
        does not provide benefits for hospital lengths of stay 
        in connection with childbirth for a mother or her 
        newborn child.
            (3) Nothing in this section shall be construed as 
        preventing a group health plan or issuer from imposing 
        deductibles, coinsurance, or other cost-sharing in 
        relation to benefits for hospital lengths of stay in 
        connection with childbirth for a mother or newborn 
        child under the plan (or under health insurance 
        coverage offered in connection with a group health 
        plan), except that such coinsurance or other cost-
        sharing for any portion of a period within a hospital 
        length of stay required under subsection (a) may not be 
        greater than such coinsurance or cost-sharing for any 
        preceding portion of such stay.
    (d) Notice.--A group health plan under this part shall 
comply with the notice requirement under section 711(d) of the 
Employee Retirement Income Security Act of 1974 with respect to 
the requirements of this section as if such section applied to 
such plan.
    (e) Level and Type of Reimbursements.--Nothing in this 
section shall be construed to prevent a group health plan or a 
health insurance issuer offering group health insurance 
coverage from negotiating the level and type of reimbursement 
with a provider for care provided in accordance with this 
section.
    (f) Preemption; Exception for Health Insurance Coverage in 
Certain States.--
            (1) In general.--The requirements of this section 
        shall not apply with respect to health insurance 
        coverage if there is a State law (as defined in section 
        2723(d)(1)) for a State that regulates such coverage 
        that is described in any of the following 
        subparagraphs:
                    (A) Such State law requires such coverage 
                to provide for at least a 48-hour hospital 
                length of stay following a normal vaginal 
                delivery and at least a 96-hour hospital length 
                of stay following a cesarean section.
                    (B) Such State law requires such coverage 
                to provide for maternity and pediatric care in 
                accordance with guidelines established by the 
                American College of Obstetricians and 
                Gynecologists, the American Academy of 
                Pediatrics, or other established professional 
                medical associations.
                    (C) Such State law requires, in connection 
                with such coverage for maternity care, that the 
                hospital length of stay for such care is left 
                to the decision of (or required to be made by) 
                the attending provider in consultation with the 
                mother.
            (2) Construction.--Section 2723(a)(1) shall not be 
        construed as superseding a State law described in 
        paragraph (1).

SEC. 2705. [300GG-5] PARITY IN MENTAL HEALTH AND SUBSTANCE USE DISORDER 
                    BENEFITS. \1\
---------------------------------------------------------------------------

    \1\ See footnote for section 2704.
---------------------------------------------------------------------------
    (a) In General.--
            (1) Aggregate lifetime limits.--In the case of a 
        group health plan (or health insurance coverage offered 
        in connection with such a plan) that provides both 
        medical and surgical benefits and mental health or 
        substance use disorder benefits--
                    (A) No lifetime limit.--If the plan or 
                coverage does not include an aggregate lifetime 
                limit on substantially all medical and surgical 
                benefits, the plan or coverage may not impose 
                any aggregate lifetime limit on mental health 
                or substance use disorder benefits.
                    (B) Lifetime limit.--If the plan or 
                coverage includes an aggregate lifetime limit 
                on substantially all medical and surgical 
                benefits (in this paragraph referred to as the 
                ``applicable lifetime limit''), the plan or 
                coverage shall either--
                            (i) apply the applicable lifetime 
                        limit both to the medical and surgical 
                        benefits to which it otherwise would 
                        apply and to mental health and 
                        substance use disorder benefits and not 
                        distinguish in the application of such 
                        limit between such medical and surgical 
                        benefits and mental health and 
                        substance use disorder benefits; or
                            (ii) not include any aggregate 
                        lifetime limit on mental health or 
                        substance use disorder benefits that is 
                        less than the applicable lifetime 
                        limit.
                    (C) Rule in case of different limits.--In 
                the case of a plan or coverage that is not 
                described in subparagraph (A) or (B) and that 
                includes no or different aggregate lifetime 
                limits on different categories of medical and 
                surgical benefits, the Secretary shall 
                establish rules under which subparagraph (B) is 
                applied to such plan or coverage with respect 
                to mental health and substance use disorder 
                benefits by substituting for the applicable 
                lifetime limit an average aggregate lifetime 
                limit that is computed taking into account the 
                weighted average of the aggregate lifetime 
                limits applicable to such categories.
            (2) Annual limits.--In the case of a group health 
        plan (or health insurance coverage offered in 
        connection with such a plan) that provides both medical 
        and surgical benefits and mental health or substance 
        use disorder benefits--
                    (A) No annual limit.--If the plan or 
                coverage does not include an annual limit on 
                substantially all medical and surgical 
                benefits, the plan or coverage may not impose 
                any annual limit on mental health or substance 
                use disorder benefits.
                    (B) Annual limit.--If the plan or coverage 
                includes an annual limit on substantially all 
                medical and surgical benefits (in this 
                paragraph referred to as the ``applicable 
                annual limit''), the plan or coverage shall 
                either--
                            (i) apply the applicable annual 
                        limit both to medical and surgical 
                        benefits to which it otherwise would 
                        apply and to mental health and 
                        substance use disorder benefits and not 
                        distinguish in the application of such 
                        limit between such medical and surgical 
                        benefits and mental health and 
                        substance use disorder benefits; or
                            (ii) not include any annual limit 
                        on mental health or substance use 
                        disorder benefits that is less than the 
                        applicable annual limit.
                    (C) Rule in case of different limits.--In 
                the case of a plan or coverage that is not 
                described in subparagraph (A) or (B) and that 
                includes no or different annual limits on 
                different categories of medical and surgical 
                benefits, the Secretary shall establish rules 
                under which subparagraph (B) is applied to such 
                plan or coverage with respect to mental health 
                and substance use disorder benefits by 
                substituting for the applicable annual limit an 
                average annual limit that is computed taking 
                into account the weighted average of the annual 
                limits applicable to such categories.
            (3) Financial requirements and treatment 
        limitations.--
                    (A) In general.--In the case of a group 
                health plan (or health insurance coverage 
                offered in connection with such a plan) that 
                provides both medical and surgical benefits and 
                mental health or substance use disorder 
                benefits, such plan or coverage shall ensure 
                that--
                            (i) the financial requirements 
                        applicable to such mental health or 
                        substance use disorder benefits are no 
                        more restrictive than the predominant 
                        financial requirements applied to 
                        substantially all medical and surgical 
                        benefits covered by the plan (or 
                        coverage), and there are no separate 
                        cost sharing requirements that are 
                        applicable only with respect to mental 
                        health or substance use disorder 
                        benefits; and
                            (ii) the treatment limitations 
                        applicable to such mental health or 
                        substance use disorder benefits are no 
                        more restrictive than the predominant 
                        treatment limitations applied to 
                        substantially all medical and surgical 
                        benefits covered by the plan (or 
                        coverage) and there are no separate 
                        treatment limitations that are 
                        applicable only with respect to mental 
                        health or substance use disorder 
                        benefits.
                    (B) Definitions.--In this paragraph:
                            (i) Financial requirement.--The 
                        term ``financial requirement'' includes 
                        deductibles, copayments, coinsurance, 
                        and out-of-pocket expenses, but 
                        excludes an aggregate lifetime limit 
                        and an annual limit subject to 
                        paragraphs (1) and (2).
                            (ii) Predominant.--A financial 
                        requirement or treatment limit is 
                        considered to be predominant if it is 
                        the most common or frequent of such 
                        type of limit or requirement.
                            (iii) Treatment limitation.--The 
                        term ``treatment limitation'' includes 
                        limits on the frequency of treatment, 
                        number of visits, days of coverage, or 
                        other similar limits on the scope or 
                        duration of treatment.
            (4) Availability of plan information.--The criteria 
        for medical necessity determinations made under the 
        plan with respect to mental health or substance use 
        disorder benefits (or the health insurance coverage 
        offered in connection with the plan with respect to 
        such benefits) shall be made available by the plan 
        administrator (or the health insurance issuer offering 
        such coverage) in accordance with regulations to any 
        current or potential participant, beneficiary, or 
        contracting provider upon request. The reason for any 
        denial under the plan (or coverage) of reimbursement or 
        payment for services with respect to mental health or 
        substance use disorder benefits in the case of any 
        participant or beneficiary shall, on request or as 
        otherwise required, be made available by the plan 
        administrator (or the health insurance issuer offering 
        such coverage) to the participant or beneficiary in 
        accordance with regulations.
            (5) Out-of-network providers.--In the case of a 
        plan or coverage that provides both medical and 
        surgical benefits and mental health or substance use 
        disorder benefits, if the plan or coverage provides 
        coverage for medical or surgical benefits provided by 
        out-of-network providers, the plan or coverage shall 
        provide coverage for mental health or substance use 
        disorder benefits provided by out-of-network providers 
        in a manner that is consistent with the requirements of 
        this section.
    (b) Construction.--Nothing in this section shall be 
construed--
            (1) as requiring a group health plan (or health 
        insurance coverage offered in connection with such a 
        plan) to provide any mental health or substance use 
        disorder benefits; or
            (2) in the case of a group health plan (or health 
        insurance coverage offered in connection with such a 
        plan) that provides mental health or substance use 
        disorder benefits, as affecting the terms and 
        conditions of the plan or coverage relating to such 
        benefits under the plan or coverage, except as provided 
        in subsection (a).
    (c) Exemptions.--
            (1) Small employer exemption.--This section shall 
        not apply to any group health plan (and group health 
        insurance coverage offered in connection with a group 
        health plan) for any plan year of a small employer (as 
        defined in section 2791(e)(4), except that for purposes 
        of this paragraph such term shall include employers 
        with 1 employee in the case of an employer residing in 
        a State that permits small groups to include a single 
        individual).
            (2) Cost exemption.--
                    (A) In general.--With respect to a group 
                health plan (or health insurance coverage 
                offered in connection with such a plan), if the 
                application of this section to such plan (or 
                coverage) results in an increase for the plan 
                year involved of the actual total costs of 
                coverage with respect to medical and surgical 
                benefits and mental health and substance use 
                disorder benefits under the plan (as determined 
                and certified under subparagraph (C)) by an 
                amount that exceeds the applicable percentage 
                described in subparagraph (B) of the actual 
                total plan costs, the provisions of this 
                section shall not apply to such plan (or 
                coverage) during the following plan year, and 
                such exemption shall apply to the plan (or 
                coverage) for 1 plan year. An employer may 
                elect to continue to apply mental health and 
                substance use disorder parity pursuant to this 
                section with respect to the group health plan 
                (or coverage) involved regardless of any 
                increase in total costs.
                    (B) Applicable percentage.--With respect to 
                a plan (or coverage), the applicable percentage 
                described in this subparagraph shall be--
                            (i) 2 percent in the case of the 
                        first plan year in which this section 
                        is applied; and
                            (ii) 1 percent in the case of each 
                        subsequent plan year.
                    (C) Determinations by actuaries.--
                Determinations as to increases in actual costs 
                under a plan (or coverage) for purposes of this 
                section shall be made and certified by a 
                qualified and licensed actuary who is a member 
                in good standing of the American Academy of 
                Actuaries. All such determinations shall be in 
                a written report prepared by the actuary. The 
                report, and all underlying documentation relied 
                upon by the actuary, shall be maintained by the 
                group health plan or health insurance issuer 
                for a period of 6 years following the 
                notification made under subparagraph (E).
                    (D) 6-month determinations.--If a group 
                health plan (or a health insurance issuer 
                offering coverage in connection with a group 
                health plan) seeks an exemption under this 
                paragraph, determinations under subparagraph 
                (A) shall be made after such plan (or coverage) 
                has complied with this section for the first 6 
                months of the plan year involved.
                    (E) Notification.--
                            (i) In general.--A group health 
                        plan (or a health insurance issuer 
                        offering coverage in connection with a 
                        group health plan) that, based upon a 
                        certification described under 
                        subparagraph (C), qualifies for an 
                        exemption under this paragraph, and 
                        elects to implement the exemption, 
                        shall promptly notify the Secretary, 
                        the appropriate State agencies, and 
                        participants and beneficiaries in the 
                        plan of such election.
                            (ii) Requirement.--A notification 
                        to the Secretary under clause (i) shall 
                        include--
                                    (I) a description of the 
                                number of covered lives under 
                                the plan (or coverage) involved 
                                at the time of the 
                                notification, and as 
                                applicable, at the time of any 
                                prior election of the cost-
                                exemption under this paragraph 
                                by such plan (or coverage);
                                    (II) for both the plan year 
                                upon which a cost exemption is 
                                sought and the year prior, a 
                                description of the actual total 
                                costs of coverage with respect 
                                to medical and surgical 
                                benefits and mental health and 
                                substance use disorder benefits 
                                under the plan; and
                                    (III) for both the plan 
                                year upon which a cost 
                                exemption is sought and the 
                                year prior, the actual total 
                                costs of coverage with respect 
                                to mental health and substance 
                                use disorder benefits under the 
                                plan.
                            (iii) Confidentiality.--A 
                        notification to the Secretary under 
                        clause (i) shall be confidential. The 
                        Secretary shall make available, upon 
                        request and on not more than an annual 
                        basis, an anonymous itemization of such 
                        notifications, that includes--
                                    (I) a breakdown of States 
                                by the size and type of 
                                employers submitting such 
                                notification; and
                                    (II) a summary of the data 
                                received under clause (ii).
                    (F) Audits by appropriate agencies.--To 
                determine compliance with this paragraph, the 
                Secretary may audit the books and records of a 
                group health plan or health insurance issuer 
                relating to an exemption, including any 
                actuarial reports prepared pursuant to 
                subparagraph (C), during the 6 year period 
                following the notification of such exemption 
                under subparagraph (E). A State agency 
                receiving a notification under subparagraph (E) 
                may also conduct such an audit with respect to 
                an exemption covered by such notification.
    (d) Separate Application to Each Option Offered.--In the 
case of a group health plan that offers a participant or 
beneficiary two or more benefit package options under the plan, 
the requirements of this section shall be applied separately 
with respect to each such option.
    (e) Definitions.--For purposes of this section--
            (1) Aggregate lifetime limit.--The term ``aggregate 
        lifetime limit'' means, with respect to benefits under 
        a group health plan or health insurance coverage, a 
        dollar limitation on the total amount that may be paid 
        with respect to such benefits under the plan or health 
        insurance coverage with respect to an individual or 
        other coverage unit.
            (2) Annual limit.--The term ``annual limit'' means, 
        with respect to benefits under a group health plan or 
        health 
        insurance coverage, a dollar limitation on the total 
        amount of benefits that may be paid with respect to 
        such benefits in a 12-month period under the plan or 
        health insurance coverage with respect to an individual 
        or other coverage unit.
            (3) Medical or surgical benefits.--The term 
        ``medical or surgical benefits'' means benefits with 
        respect to 
        medical or surgical services, as defined under the 
        terms of the plan or coverage (as the case may be), but 
        does not include mental health or substance use 
        disorder benefits.
            (4) Mental health benefits.--The term ``mental 
        health benefits'' means benefits with respect to 
        services for mental health conditions, as defined under 
        the terms of the plan and in accordance with applicable 
        Federal and State law.
            (5) Substance use disorder benefits.--The term 
        ``substance use disorder benefits'' means benefits with 
        respect to services for substance use disorders, as 
        defined under the terms of the plan and in accordance 
        with applicable Federal and State law.

SEC. 2706. [300GG-6] REQUIRED COVERAGE FOR RECONSTRUCTIVE SURGERY 
                    FOLLOWING MASTECTOMIES. \1\
---------------------------------------------------------------------------

    \1\ See footnote for section 2704.
---------------------------------------------------------------------------
    The provisions of section 713 of the Employee Retirement 
Income Security Act of 1974 shall apply to group health plans, 
and health insurance issuers providing health insurance 
coverage in connection with group health plans, as if included 
in this subpart. \2\
---------------------------------------------------------------------------
    \2\ Section 2706 was added by subsection (a) of section 903 of the 
Departments of Labor, Health and Human Services, and Education, and 
Related Agencies Appropriations Act, 1999 (as contained in section 
101(f) of division A of Public Law 105-277; 112 Stat. 2681-438). 
Subsection (c) of such section 903 concerns effective dates, and 
paragraph (1) of the subsection provides as follows:
---------------------------------------------------------------------------

          ``(1) Group plans.--

                  ``(A) In general.--The amendment made by subsection 
                (a) shall apply to group health plans for plan years 
                beginning on or after the date of enactment of this 
                Act.
                  ``(B) Special rule for collective bargaining 
                agreements.--In the case of a group health plan 
                maintained pursuant to 1 or more collective bargaining 
                agreements between employee representatives and 1 or 
                more employers, any plan amendment made pursuant to a 
                collective bargaining agreement relating to the plan 
                which amends the plan solely to conform to any 
                requirement added by the amendment made by subsection 
                (a) shall not be treated as a termination of such 
                collective bargaining agreement.''.
---------------------------------------------------------------------------
    The Public Law was enacted October 21, 1998.
---------------------------------------------------------------------------

SEC. 2707. [300GG-7] COVERAGE OF DEPENDENT STUDENTS ON MEDICALLY 
                    NECESSARY LEAVE OF ABSENCE. \1\
---------------------------------------------------------------------------

    \1\ See footnote for section 2704.
---------------------------------------------------------------------------
    (a) Medically Necessary Leave of Absence.--In this section, 
the term ``medically necessary leave of absence'' means, with 
respect to a dependent child described in subsection (b)(2) in 
connection with a group health plan or health insurance 
coverage offered in connection with such plan, a leave of 
absence of such child from a postsecondary educational 
institution (including an institution of higher education as 
defined in section 102 of the Higher Education Act of 1965), or 
any other change in enrollment of such child at such an 
institution, that--
            (1) commences while such child is suffering from a 
        serious illness or injury;
            (2) is medically necessary; and
            (3) causes such child to lose student status for 
        purposes of coverage under the terms of the plan or 
        coverage.
    (b) Requirement To Continue Coverage.--
            (1) In general.--In the case of a dependent child 
        described in paragraph (2), a group health plan, or a 
        health insurance issuer that provides health insurance 
        coverage in connection with a group health plan, shall 
        not terminate coverage of such child under such plan or 
        health insurance coverage due to a medically necessary 
        leave of absence before the date that is the earlier 
        of--
                    (A) the date that is 1 year after the first 
                day of the medically necessary leave of 
                absence; or
                    (B) the date on which such coverage would 
                otherwise terminate under the terms of the plan 
                or health insurance coverage.
            (2) Dependent child described.--A dependent child 
        described in this paragraph is, with respect to a group 
        health plan or health insurance coverage offered in 
        connection with the plan, a beneficiary under the plan 
        who--
                    (A) is a dependent child, under the terms 
                of the plan or coverage, of a participant or 
                beneficiary under the plan or coverage; and
                    (B) was enrolled in the plan or coverage, 
                on the basis of being a student at a 
                postsecondary educational institution (as 
                described in subsection (a)), immediately 
                before the first day of the medically necessary 
                leave of absence involved.
            (3) Certification by physician.--Paragraph (1) 
        shall apply to a group health plan or health insurance 
        coverage offered by an issuer in connection with such 
        plan only if the plan or issuer of the coverage has 
        received written certification by a treating physician 
        of the dependent child which states that the child is 
        suffering from a serious illness or injury and that the 
        leave of absence (or other change of enrollment) 
        described in subsection (a) is medically necessary.
    (c) Notice.--A group health plan, and a health insurance 
issuer providing health insurance coverage in connection with a 
group health plan, shall include, with any notice regarding a 
requirement for certification of student status for coverage 
under the plan or coverage, a description of the terms of this 
section for continued coverage during medically necessary 
leaves of absence. Such description shall be in language which 
is understandable to the typical plan participant.
    (d) No Change in Benefits.--A dependent child whose 
benefits are continued under this section shall be entitled to 
the same benefits as if (during the medically necessary leave 
of absence) the child continued to be a covered student at the 
institution of higher education and was not on a medically 
necessary leave of absence.
    (e) Continued Application in Case of Changed Coverage.--
If--
            (1) a dependent child of a participant or 
        beneficiary is in a period of coverage under a group 
        health plan or health insurance coverage offered in 
        connection with such a plan, pursuant to a medically 
        necessary leave of absence of the child described in 
        subsection (b);
            (2) the manner in which the participant or 
        beneficiary is covered under the plan changes, whether 
        through a change in health insurance coverage or health 
        insurance issuer, a change between health insurance 
        coverage and self-insured coverage, or otherwise; and
            (3) the coverage as so changed continues to provide 
        coverage of beneficiaries as dependent children,
this section shall apply to coverage of the child under the 
changed coverage for the remainder of the period of the 
medically necessary leave of absence of the dependent child 
under the plan in the same manner as it would have applied if 
the changed coverage had been the previous coverage.

   Subpart 3--Provisions Applicable Only to Health Insurance Issuers

SEC. 2711. [300GG-11] GUARANTEED AVAILABILITY OF COVERAGE FOR EMPLOYERS 
                    IN THE GROUP MARKET. \1\
---------------------------------------------------------------------------

    \1\ Effective September 23, 2010, section 1001(3) of Public Law 
111-148 provides an amendment to redesignate sections 2711 through 2713 
as sections 2731 through 2733.
---------------------------------------------------------------------------
    (a) Issuance of Coverage in the Small Group Market.--
            (1) In general.--Subject to subsections (c) through 
        (f), each health insurance issuer that offers health 
        insurance coverage in the small group market in a 
        State--
                    (A) must accept every small employer (as 
                defined in section 2791(e)(4)) in the State 
                that applies for such coverage; and
                    (B) must accept for enrollment under such 
                coverage every eligible individual (as defined 
                in paragraph (2)) who applies for enrollment 
                during the period in which the individual first 
                becomes eligible to enroll under the terms of 
                the group health plan and may not place any 
                restriction which is inconsistent with section 
                2702 on an eligible individual being a 
                participant or beneficiary.
            (2) Eligible individual defined.--For purposes of 
        this section, the term ``eligible individual'' means, 
        with respect to a health insurance issuer that offers 
        health insurance coverage to a small employer in 
        connection with a group health plan in the small group 
        market, such an individual in relation to the employer 
        as shall be determined--
                    (A) in accordance with the terms of such 
                plan,
                    (B) as provided by the issuer under rules 
                of the issuer which are uniformly applicable in 
                a State to small employers in the small group 
                market, and
                    (C) in accordance with all applicable State 
                laws governing such issuer and such market.
    (b) Assuring Access in the Large Group Market.--
            (1) Reports to hhs.--The Secretary shall request 
        that the chief executive officer of each State submit 
        to the Secretary, by not later December 31, 2000, and 
        every 3 years thereafter a report on--
                    (A) the access of large employers to health 
                insurance coverage in the State, and
                    (B) the circumstances for lack of access 
                (if any) of large employers (or one or more 
                classes of such employers) in the State to such 
                coverage.
            (2) Triennial reports to congress.--The Secretary, 
        based on the reports submitted under paragraph (1) and 
        such other information as the Secretary may use, shall 
        prepare and submit to Congress, every 3 years, a report 
        describing the extent to which large employers (and 
        classes of such employers) that seek health insurance 
        coverage in the different States are able to obtain 
        access to such coverage. Such report shall include such 
        recommendations as the Secretary determines to be 
        appropriate.
            (3) GAO report on large employer access to health 
        insurance coverage.--The Comptroller General shall 
        provide for a study of the extent to which classes of 
        large employers in the different States are able to 
        obtain access to health insurance coverage and the 
        circumstances for lack of access (if any) to such 
        coverage. The Comptroller General shall submit to 
        Congress a report on such study not later than 18 
        months after the date of the enactment of this title.
    (c) Special Rules for Network Plans.--
            (1) In general.--In the case of a health insurance 
        issuer that offers health insurance coverage in the 
        small group market through a network plan, the issuer 
        may--
                    (A) limit the employers that may apply for 
                such coverage to those with eligible 
                individuals who live, work, or reside in the 
                service area for such network plan; and
                    (B) within the service area of such plan, 
                deny such coverage to such employers if the 
                issuer has demonstrated, if required, to the 
                applicable State authority that--
                            (i) it will not have the capacity 
                        to deliver services adequately to 
                        enrollees of any additional groups 
                        because of its obligations to existing 
                        group contract holders and enrollees, 
                        and
                            (ii) it is applying this paragraph 
                        uniformly to all employers without 
                        regard to the claims experience of 
                        those employers and their employees 
                        (and their dependents) or any health 
                        status-related factor relating to such 
                        employees and dependents.
            (2) 180-day suspension upon denial of coverage.--An 
        issuer, upon denying health insurance coverage in any 
        service area in accordance with paragraph (1)(B), may 
        not offer coverage in the small group market within 
        such service area for a period of 180 days after the 
        date such coverage is denied.
    (d) Application of Financial Capacity Limits.--
            (1) In general.--A health insurance issuer may deny 
        health insurance coverage in the small group market if 
        the issuer has demonstrated, if required, to the 
        applicable State authority that--
                    (A) it does not have the financial reserves 
                necessary to underwrite additional coverage; 
                and
                    (B) it is applying this paragraph uniformly 
                to all employers in the small group market in 
                the State consistent with applicable State law 
                and without regard to the claims experience of 
                those employers and their employees (and their 
                dependents) or any health status-related factor 
                relating to such employees and dependents.
            (2) 180-day suspension upon denial of coverage.--A 
        health insurance issuer upon denying health insurance 
        coverage in connection with group health plans in 
        accordance with paragraph (1) in a State may not offer 
        coverage in connection with group health plans in the 
        small group market in the State for a period of 180 
        days after the date such coverage is denied or until 
        the issuer has demonstrated to the applicable State 
        authority, if required under applicable State law, that 
        the issuer has sufficient financial reserves to 
        underwrite additional coverage, whichever is later. An 
        applicable State authority may provide for the 
        application of this subsection on a service-area-
        specific basis.
    (e) Exception to Requirement for Failure To Meet Certain 
Minimum Participation or Contribution Rules.--
            (1) In general.--Subsection (a) shall not be 
        construed to preclude a health insurance issuer from 
        establishing employer contribution rules or group 
        participation rules for the offering of health 
        insurance coverage in connection with a group health 
        plan in the small group market, as allowed under 
        applicable State law.
            (2) Rules defined.--For purposes of paragraph (1)--
                    (A) the term ``employer contribution rule'' 
                means a requirement relating to the minimum 
                level or amount of employer contribution toward 
                the premium for enrollment of participants and 
                beneficiaries; and
                    (B) the term ``group participation rule'' 
                means a requirement relating to the minimum 
                number of participants or beneficiaries that 
                must be enrolled in relation to a specified 
                percentage or number of eligible individuals or 
                employees of an employer.
    (f) Exception for Coverage Offered Only to Bona Fide 
Association Members.--Subsection (a) shall not apply to health 
insurance coverage offered by a health insurance issuer if such 
coverage is made available in the small group market only 
through one or more bona fide associations (as defined in 
section 2791(d)(3)).

SEC. 2712. [300GG-12] GUARANTEED RENEWABILITY OF COVERAGE FOR EMPLOYERS 
                    IN THE GROUP MARKET. \1\
---------------------------------------------------------------------------

    \1\ See footnote for section 2711.
---------------------------------------------------------------------------
    (a) In General.--Except as provided in this section, if a 
health insurance issuer offers health insurance coverage in the 
small or large group market in connection with a group health 
plan, the issuer must renew or continue in force such coverage 
at the option of the plan sponsor of the plan.
    (b) General Exceptions.--A health insurance issuer may 
nonrenew or discontinue health insurance coverage offered in 
connection with a group health plan in the small or large group 
market based only on one or more of the following:
            (1) Nonpayment of premiums.--The plan sponsor has 
        failed to pay premiums or contributions in accordance 
        with the terms of the health insurance coverage or the 
        issuer has not received timely premium payments.
            (2) Fraud.--The plan sponsor has performed an act 
        or practice that constitutes fraud or made an 
        intentional misrepresentation of material fact under 
        the terms of the coverage.
            (3) Violation of participation or contribution 
        rules.--The plan sponsor has failed to comply with a 
        material plan provision relating to employer 
        contribution or group participation rules, as permitted 
        under section 2711(e) in the case of the small group 
        market or pursuant to applicable State law in the case 
        of the large group market.
            (4) Termination of coverage.--The issuer is ceasing 
        to offer coverage in such market in accordance with 
        subsection (c) and applicable State law.
            (5) Movement outside service area.--In the case of 
        a health insurance issuer that offers health insurance 
        coverage in the market through a network plan, there is 
        no longer any enrollee in connection with such plan who 
        lives, resides, or works in the service area of the 
        issuer (or in the area for which the issuer is 
        authorized to do business) and, in the case of the 
        small group market, the issuer would deny enrollment 
        with respect to such plan under section 2711(c)(1)(A).
            (6) Association membership ceases.--In the case of 
        health insurance coverage that is made available in the 
        small or large group market (as the case may be) only 
        through one or more bona fide associations, the 
        membership of an employer in the association (on the 
        basis of which the coverage is provided) ceases but 
        only if such coverage is terminated under this 
        paragraph uniformly without regard to any health 
        status-related factor relating to any covered 
        individual.
    (c) Requirements for Uniform Termination of Coverage.--
            (1) Particular type of coverage not offered.--In 
        any case in which an issuer decides to discontinue 
        offering a particular type of group health insurance 
        coverage offered in the small or large group market, 
        coverage of such type may be discontinued by the issuer 
        in accordance with applicable State law in such market 
        only if--
                    (A) the issuer provides notice to each plan 
                sponsor provided coverage of this type in such 
                market (and participants and beneficiaries 
                covered under such coverage) of such 
                discontinuation at least 90 days prior to the 
                date of the discontinuation of such coverage;
                    (B) the issuer offers to each plan sponsor 
                provided coverage of this type in such market, 
                the option to purchase all (or, in the case of 
                the large group market, any) other health 
                insurance coverage currently being offered by 
                the issuer to a group health plan in such 
                market; and
                    (C) in exercising the option to discontinue 
                coverage of this type and in offering the 
                option of coverage under subparagraph (B), the 
                issuer acts uniformly without regard to the 
                claims experience of those sponsors or any 
                health status-related factor relating to any 
                participants or beneficiaries covered or new 
                participants or beneficiaries who may become 
                eligible for such coverage.
            (2) Discontinuance of all coverage.--
                    (A) In general.--In any case in which a 
                health insurance issuer elects to discontinue 
                offering all health insurance coverage in the 
                small group market or the large group market, 
                or both markets, in a State, health insurance 
                coverage may be discontinued by the issuer only 
                in accordance with applicable State law and 
                if--
                            (i) the issuer provides notice to 
                        the applicable State authority and to 
                        each plan sponsor (and participants and 
                        beneficiaries covered under such 
                        coverage) of such discontinuation at 
                        least 180 days prior to the date of the 
                        discontinuation of such coverage; and
                            (ii) all health insurance issued or 
                        delivered for issuance in the State in 
                        such market (or markets) are 
                        discontinued and coverage under such 
                        health insurance coverage in such 
                        market (or markets) is not renewed.
                    (B) Prohibition on market reentry.--In the 
                case of a discontinuation under subparagraph 
                (A) in a market, the issuer may not provide for 
                the issuance of any health insurance coverage 
                in the market and State involved during the 5-
                year period beginning on the date of the 
                discontinuation of the last health insurance 
                coverage not so renewed.
    (d) Exception for Uniform Modification of Coverage.--At the 
time of coverage renewal, a health insurance issuer may modify 
the health insurance coverage for a product offered to a group 
health plan--
            (1) in the large group market; or
            (2) in the small group market if, for coverage that 
        is available in such market other than only through one 
        or more bona fide associations, such modification is 
        consistent with State law and effective on a uniform 
        basis among group health plans with that product.
    (e) Application to Coverage Offered Only Through 
Associations.--In applying this section in the case of health 
insurance coverage that is made available by a health insurance 
issuer in the small or large group market to employers only 
through one or more associations, a reference to ``plan 
sponsor'' is deemed, with respect to coverage provided to an 
employer member of the association, to include a reference to 
such employer.

SEC. 2713. [300GG-13] DISCLOSURE OF INFORMATION. \1\
---------------------------------------------------------------------------

    \1\ See footnote for section 2711.
---------------------------------------------------------------------------
    (a) Disclosure of Information by Health Plan Issuers.--In 
connection with the offering of any health insurance coverage 
to a small employer, a health insurance issuer--
            (1) shall make a reasonable disclosure to such 
        employer, as part of its solicitation and sales 
        materials, of the availability of information described 
        in subsection (b), and
            (2) upon request of such a small employer, provide 
        such information.
    (b) Information Described.--
            (1) In general.--Subject to paragraph (3), with 
        respect to a health insurance issuer offering health 
        insurance coverage to a small employer, information 
        described in this subsection is information 
        concerning--
                    (A) the provisions of such coverage 
                concerning issuer's right to change premium 
                rates and the factors that may affect changes 
                in premium rates;
                    (B) the provisions of such coverage 
                relating to renewability of coverage;
                    (C) the provisions of such coverage 
                relating to any preexisting condition 
                exclusion; and
                    (D) the benefits and premiums available 
                under all health insurance coverage for which 
                the employer is qualified.
            (2) Form of information.--Information under this 
        subsection shall be provided to small employers in a 
        manner determined to be understandable by the average 
        small employer, and shall be sufficient to reasonably 
        inform small employers of their rights and obligations 
        under the health insurance coverage.
            (3) Exception.--An issuer is not required under 
        this section to disclose any information that is 
        proprietary and trade secret information under 
        applicable law.

         Subpart 4--Exclusion of Plans; Enforcement; Preemption

SEC. 2721. \2\ [300GG-21] EXCLUSION OF CERTAIN PLANS. \1\
---------------------------------------------------------------------------

    \1\ Section 604(b) of Public Law 104-204 (110 Stat. 2940) provided 
that various provisions of section 2721 are amended by striking 
``subparts 1 and 2'' and inserting ``subparts 1 and 3''. Subsection (c) 
of such section provides as follows:

      (c) Effective Date.--The amendments made by this section shall 
apply with respect to group health plans for plan years beginning on or 
after January 1, 1998.
    \2\ Effective September 23, 2010, section 1001(4) of Public Law 
111-148 provides an amendment to redesignate sections 2721 through 2723 
as sections 2735 through 2737.
---------------------------------------------------------------------------
    (a) Exception for Certain Small Group Health Plans.--The 
requirements of subparts 1 and 3 \1\ shall not apply to any 
group health plan (and health insurance coverage offered in 
connection with a group health plan) for any plan year if, on 
the first day of such plan year, such plan has less than 2 
participants who are current employees.
    (b) Limitation on Application of Provisions Relating to 
Group Health Plans.--
            (1) In general.--The requirements of subparts 1 
        through 3 shall apply with respect to group health 
        plans only--
                    (A) subject to paragraph (2), in the case 
                of a plan that is a nonfederal governmental 
                plan, and
                    (B) with respect to health insurance 
                coverage offered in connection with a group 
                health plan (including such a plan that is a 
                church plan or a governmental plan).
            (2) Treatment of nonfederal governmental plans.--
                    (A) Election to be excluded.--Except as 
                provided in subparagraph (D), if the plan 
                sponsor of a nonfederal governmental plan which 
                is a group health plan to which the provisions 
                of subparts 1 through 3 otherwise apply makes 
                an election under this subparagraph (in such 
                form and manner as the Secretary may by 
                regulations prescribe), then the requirements 
                of such subparts insofar as they apply directly 
                to group health plans (and not merely to group 
                health insurance coverage) shall not apply to 
                such governmental plans for such period except 
                as provided in this paragraph.
                    (B) Period of election.--An election under 
                subparagraph (A) shall apply--
                            (i) for a single specified plan 
                        year, or
                            (ii) in the case of a plan provided 
                        pursuant to a collective bargaining 
                        agreement, for the term of such 
                        agreement.
                An election under clause (i) may be extended 
                through subsequent elections under this 
                paragraph.
                    (C) Notice to enrollees.--Under such an 
                election, the plan shall provide for--
                            (i) notice to enrollees (on an 
                        annual basis and at the time of 
                        enrollment under the plan) of the fact 
                        and consequences of such election, and
                            (ii) certification and disclosure 
                        of creditable coverage under the plan 
                        with respect to enrollees in accordance 
                        with section 2701(e).
                    (D) Election not applicable to requirements 
                concerning genetic information.--The election 
                described in subparagraph (A) shall not be 
                available with respect to the provisions of 
                subsections (a)(1)(F), (b)(3), (c), and (d) of 
                section 2702 and the provisions of sections 
                2701 and 2702(b) to the extent that such 
                provisions apply to genetic information.
    (c) Exception for Certain Benefits.--The requirements of 
subparts 1 through 3 shall not apply to any group health plan 
(or group health insurance coverage) in relation to its 
provision of excepted benefits described in section 2791(c)(1).
    (d) Exception for Certain Benefits If Certain Conditions 
Met.--
            (1) Limited, excepted benefits.--The requirements 
        of subparts 1 through 3 shall not apply to any group 
        health plan (and group health insurance coverage 
        offered in connection with a group health plan) in 
        relation to its provision of excepted benefits 
        described in section 2791(c)(2) if the benefits--
                    (A) are provided under a separate policy, 
                certificate, or contract of insurance; or
                    (B) are otherwise not an integral part of 
                the plan.
            (2) Noncoordinated, excepted benefits.--The 
        requirements of subparts 1 through 3 shall not apply to 
        any group health plan (and group health insurance 
        coverage offered in connection with a group health 
        plan) in relation to its provision of excepted benefits 
        described in section 2791(c)(3) if all of the following 
        conditions are met:
                    (A) The benefits are provided under a 
                separate policy, certificate, or contract of 
                insurance.
                    (B) There is no coordination between the 
                provision of such benefits and any exclusion of 
                benefits under any group health plan maintained 
                by the same plan sponsor.
                    (C) Such benefits are paid with respect to 
                an event without regard to whether benefits are 
                provided with respect to such an event under 
                any group health plan maintained by the same 
                plan sponsor.
            (3) Supplemental excepted benefits.--The 
        requirements of this part shall not apply to any group 
        health plan (and group health insurance coverage) in 
        relation to its provision of excepted benefits 
        described in section 27971(c)(4) if the benefits are 
        provided under a separate policy, certificate, or 
        contract of insurance.
    (e) Treatment of Partnerships.--For purposes of this part--
            (1) Treatment as a group health plan.--Any plan, 
        fund, or program which would not be (but for this 
        subsection) an employee welfare benefit plan and which 
        is established or maintained by a partnership, to the 
        extent that such plan, fund, or program provides 
        medical care (including items and services paid for as 
        medical care) to present or former partners in the 
        partnership or to their dependents (as defined under 
        the terms of the plan, fund, or program), directly or 
        through insurance, reimbursement, or otherwise, shall 
        be treated (subject to paragraph (2)) as an employee 
        welfare benefit plan which is a group health plan.
            (2) Employer.--In the case of a group health plan, 
        the term ``employer'' also includes the partnership in 
        relation to any partner.
            (3) Participants of group health plans.--In the 
        case of a group health plan, the term ``participant'' 
        also includes--
                    (A) in connection with a group health plan 
                maintained by a partnership, an individual who 
                is a partner in relation to the partnership, or
                    (B) in connection with a group health plan 
                maintained by a self-employed individual (under 
                which one or more employees are participants), 
                the self-employed individual,
        if such individual is, or may become, eligible to 
        receive a benefit under the plan or such individual's 
        beneficiaries may be eligible to receive any such 
        benefit.

SEC. 2722. [300GG-22] ENFORCEMENT.

    (a) State Enforcement.--
            (1) State authority.--Subject to section 2723, each 
        State may require that health insurance issuers that 
        issue, sell, renew, or offer health insurance coverage 
        in the State in the small or large group markets meet 
        the requirements of this part with respect to such 
        issuers.
            (2) Failure to implement provisions.--In the case 
        of a determination by the Secretary that a State has 
        failed to substantially enforce a provision (or 
        provisions) in this part with respect to health 
        insurance issuers in the State, the Secretary shall 
        enforce such provision (or provisions) under subsection 
        (b) insofar as they relate to the issuance, sale, 
        renewal, and offering of health insurance coverage in 
        connection with group health plans in such State.
    (b) Secretarial Enforcement Authority.--
            (1) Limitation.--The provisions of this subsection 
        shall apply to enforcement of a provision (or 
        provisions) of this part only--
                    (A) as provided under subsection (a)(2); 
                and
                    (B) with respect to group health plans that 
                are non-Federal governmental plans.
            (2) Imposition of penalties.--In the cases 
        described in paragraph (1)--
                    (A) In general.--Subject to the succeeding 
                provisions of this subsection, any non-Federal 
                governmental plan that is a group health plan 
                and any health insurance issuer that fails to 
                meet a provision of this part applicable to 
                such plan or issuer is subject to a civil money 
                penalty under this subsection.
                    (B) Liability for penalty.--In the case of 
                a 
                failure by--
                            (i) a health insurance issuer, the 
                        issuer is liable for such penalty, or
                            (ii) a group health plan that is a 
                        non-Federal governmental plan which 
                        is--
                                    (I) sponsored by 2 or more 
                                employers, the plan is liable 
                                for such penalty, or
                                    (II) not so sponsored, the 
                                employer is liable for such 
                                penalty.
                    (C) Amount of penalty.--
                            (i) In general.--The maximum amount 
                        of penalty imposed under this paragraph 
                        is $100 for each day for each 
                        individual with respect to which such a 
                        failure occurs.
                            (ii) Considerations in 
                        imposition.--In determining the amount 
                        of any penalty to be assessed under 
                        this paragraph, the Secretary shall 
                        take into account the previous record 
                        of compliance of the entity being 
                        assessed with the applicable provisions 
                        of this part and the gravity of the 
                        violation.
                            (iii) Limitations.--
                                    (I) Penalty not to apply 
                                where failure not discovered 
                                exercising reasonable 
                                diligence.--No civil money 
                                penalty shall be imposed under 
                                this paragraph on any failure 
                                during any period for which it 
                                is established to the 
                                satisfaction of the Secretary 
                                that none of the entities 
                                against whom the penalty would 
                                be imposed knew, or exercising 
                                reasonable diligence would have 
                                known, that such failure 
                                existed.
                                    (II) Penalty not to apply 
                                to failures corrected within 30 
                                days.--No civil money penalty 
                                shall be imposed under this 
                                paragraph on any failure if 
                                such failure was due to 
                                reasonable cause and not to 
                                willful neglect, and such 
                                failure is corrected during the 
                                30-day period beginning on the 
                                first day any of the entities 
                                against whom the penalty would 
                                be imposed knew, or exercising 
                                reasonable diligence would have 
                                known, that such failure 
                                existed.
                    (D) Administrative review.--
                            (i) Opportunity for hearing.--The 
                        entity assessed shall be afforded an 
                        opportunity for hearing by the 
                        Secretary upon request made within 30 
                        days after the date of the issuance of 
                        a notice of assessment. In such hearing 
                        the decision shall be made on the 
                        record pursuant to section 554 of title 
                        5, United States Code. If no hearing is 
                        requested, the assessment shall 
                        constitute a final and unappealable 
                        order.
                            (ii) Hearing procedure.--If a 
                        hearing is requested, the initial 
                        agency decision shall be made by an 
                        administrative law judge, and such 
                        decision shall become the final order 
                        unless the Secretary modifies or 
                        vacates the decision. Notice of intent 
                        to modify or vacate the decision of the 
                        administrative law judge shall be 
                        issued to the parties within 30 days 
                        after the date of the decision of the 
                        judge. A final order which takes effect 
                        under this paragraph shall be 
                        subject to review only as provided 
                        under subparagraph (E).
                    (E) Judicial review.--
                            (i) Filing of action for review.--
                        Any entity against whom an order 
                        imposing a civil money penalty has been 
                        entered after an agency hearing under 
                        this paragraph may obtain review by the 
                        United States district court for any 
                        district in which such entity is 
                        located or the United States District 
                        Court for the District of Columbia by 
                        filing a notice of appeal in such court 
                        within 30 days from the date of such 
                        order, and simultaneously sending a 
                        copy of such notice by registered mail 
                        to the Secretary.
                            (ii) Certification of 
                        administrative record.--The Secretary 
                        shall promptly certify and file in such 
                        court the record upon which the penalty 
                        was imposed.
                            (iii) Standard for review.--The 
                        findings of the Secretary shall be set 
                        aside only if found to be unsupported 
                        by substantial evidence as provided by 
                        section 706(2)(E) of title 5, United 
                        States Code.
                            (iv) Appeal.--Any final decision, 
                        order, or judgment of the district 
                        court concerning such review shall be 
                        subject to appeal as provided in 
                        chapter 83 of title 28 of such Code.
                    (F) Failure to pay assessment; maintenance 
                of action.--
                            (i) Failure to pay assessment.--If 
                        any entity fails to pay an assessment 
                        after it has become a final and 
                        unappealable order, or after the court 
                        has entered final judgment in favor of 
                        the Secretary, the Secretary shall 
                        refer the matter to the Attorney 
                        General who shall recover the amount 
                        assessed by action in the appropriate 
                        United States district court.
                            (ii) Nonreviewability.--In such 
                        action the validity and appropriateness 
                        of the final order imposing the penalty 
                        shall not be subject to review.
                    (G) Payment of penalties.--Except as 
                otherwise provided, penalties collected under 
                this paragraph shall be paid to the Secretary 
                (or other officer) imposing the penalty and 
                shall be available without appropriation and 
                until expended for the purpose of enforcing the 
                provisions with respect to which the penalty 
                was imposed.
            (3) Enforcement authority relating to genetic 
        discrimination.--
                    (A) General rule.--In the cases described 
                in paragraph (1), notwithstanding the 
                provisions of paragraph (2)(C), the succeeding 
                subparagraphs of this paragraph shall apply 
                with respect to an action under this subsection 
                by the Secretary with respect to any failure of 
                a health insurance issuer in connection with a 
                group health plan, to meet the requirements of 
                subsection (a)(1)(F), (b)(3), (c), or (d) of 
                section 2702 or section 2701 or 2702(b)(1) with 
                respect to genetic information in connection 
                with the plan.
                    (B) Amount.--
                            (i) In general.--The amount of the 
                        penalty imposed under this paragraph 
                        shall be $100 for each day in the 
                        noncompliance period with respect to 
                        each participant or beneficiary to whom 
                        such failure relates.
                            (ii) Noncompliance period.--For 
                        purposes of this paragraph, the term 
                        ``noncompliance period'' means, with 
                        respect to any failure, the period--
                                    (I) beginning on the date 
                                such failure first occurs; and
                                    (II) ending on the date the 
                                failure is corrected.
                    (C) Minimum penalties where failure 
                discovered.--Notwithstanding clauses (i) and 
                (ii) of subparagraph (D):
                            (i) In general.--In the case of 1 
                        or more failures with respect to an 
                        individual--
                                    (I) which are not corrected 
                                before the date on which the 
                                plan receives a notice from the 
                                Secretary of such violation; 
                                and
                                    (II) which occurred or 
                                continued during the period 
                                involved;
                        the amount of penalty imposed by 
                        subparagraph (A) by reason of such 
                        failures with respect to such 
                        individual shall not be less than 
                        $2,500.
                            (ii) Higher minimum penalty where 
                        violations are more than de minimis.--
                        To the extent violations for which any 
                        person is liable under this paragraph 
                        for any year are more than de minimis, 
                        clause (i) shall be applied by 
                        substituting ``$15,000'' for ``$2,500'' 
                        with respect to such person.
                    (D) Limitations.--
                            (i) Penalty not to apply where 
                        failure not discovered exercising 
                        reasonable diligence.--No penalty shall 
                        be imposed by subparagraph (A) on any 
                        failure during any period for which it 
                        is established to the satisfaction of 
                        the Secretary that the person otherwise 
                        liable for such penalty did not know, 
                        and exercising reasonable diligence 
                        would not have known, that such failure 
                        existed.
                            (ii) Penalty not to apply to 
                        failures corrected within certain 
                        periods.--No penalty shall be imposed 
                        by subparagraph (A) on any failure if--
                                    (I) such failure was due to 
                                reasonable cause and not to 
                                willful neglect; and
                                    (II) such failure is 
                                corrected during the 30-day 
                                period beginning on the first 
                                date the person otherwise 
                                liable for such penalty knew, 
                                or exercising reasonable 
                                diligence would have known, 
                                that such failure existed.
                            (iii) Overall limitation for 
                        unintentional failures.--In the case of 
                        failures which are due to reasonable 
                        cause and not to willful neglect, the 
                        penalty imposed by subparagraph (A) for 
                        failures shall not exceed the amount 
                        equal to the lesser of--
                                    (I) 10 percent of the 
                                aggregate amount paid or 
                                incurred by the employer (or 
                                predecessor employer) during 
                                the preceding taxable year for 
                                group health plans; or
                                    (II) $500,000.
                    (E) Waiver by secretary.--In the case of a 
                failure which is due to reasonable cause and 
                not to willful neglect, the Secretary may waive 
                part or all of the penalty imposed by 
                subparagraph (A) to the extent that the payment 
                of such penalty would be excessive relative to 
                the failure involved.

SEC. 2723. [300GG-23] PREEMPTION; STATE FLEXIBILITY; CONSTRUCTION.

    (a) Continued Applicability of State Law With Respect to 
Health Insurance Issuers.--
            (1) In General.--Subject to paragraph (2) and 
        except as provided in subsection (b), this part and 
        part C insofar as it relates to this part shall not be 
        construed to supersede any provision of State law which 
        establishes, implements, or continues in effect any 
        standard or requirement solely relating to health 
        insurance issuers in connection with group health 
        insurance coverage except to the extent that such 
        standard or requirement prevents the application of a 
        requirement of this part.
            (2) Continued preemption with respect to group 
        health plans.--Nothing in this part shall be construed 
        to affect or modify the provisions of section 514 of 
        the Employee Retirement Income Security Act of 1974 
        with respect to group health plans.
    (b) Special Rules in Case of Portability Requirements.--
            (1) In general.--Subject to paragraph (2), the 
        provisions of this part relating to health insurance 
        coverage offered by a health insurance issuer supersede 
        any provision of State law which establishes, 
        implements, or continues in effect a standard or 
        requirement applicable to imposition of a preexisting 
        condition exclusion specifically governed by section 
        701 which differs from the standards or requirements 
        specified in such section.
            (2) Exceptions.--Only in relation to health 
        insurance coverage offered by a health insurance 
        issuer, the provisions of this part do not supersede 
        any provision of State law to the extent that such 
        provision--
                    (i) \1\ substitutes for the reference to 
                ``6-month period'' in section 2701(a)(1) a 
                reference to any shorter period of time;
---------------------------------------------------------------------------
    \1\ Clauses (i) through (vii) probably should be redesignated as 
subparagraphs (A) through (G). See section 102(a) of Public Law 104-191 
(110 Stat. 1971).
---------------------------------------------------------------------------
                    (ii) \1\ substitutes for the reference to 
                ``12 months'' and ``18 months'' in section 
                2701(a)(2) a reference to any shorter period of 
                time;
                    (iii) \1\ substitutes for the references to 
                ``63'' days in sections 2701(c)(2)(A) and 
                2701(d)(4)(A) a reference to any greater number 
                of days;
                    (iv) \1\ substitutes for the reference to 
                ``30-day period'' in sections 2701(b)(2) and 
                2701(d)(1) a reference to any greater period;
                    (v) \1\ prohibits the imposition of any 
                preexisting condition exclusion in cases not 
                described in section 2701(d) or expands the 
                exceptions described in such section;
                    (vi) \1\ requires special enrollment 
                periods in addition to those required under 
                section 2701(f); or
                    (vii) \1\ reduces the maximum period 
                permitted in an affiliation period under 
                section 2701(g)(1)(B).
    (c) Rules of Construction.--Nothing in this part (other 
than section 2704) shall be construed as requiring a group 
health plan or health insurance coverage to provide specific 
benefits under the terms of such plan or coverage.
    (d) Definitions.--For purposes of this section--
            (1) State law.--The term ``State law'' includes all 
        laws, decisions, rules, regulations, or other State 
        action having the effect of law, of any State. A law of 
        the United States applicable only to the District of 
        Columbia shall be treated as a State law rather than a 
        law of the United States.
            (2) State.--The term ``State'' includes a State 
        (including the Northern Mariana Islands), any political 
        subdivisions of a State or such Islands, or any agency 
        or instrumentality of either.

======================================================================


    [Note: Effective on January 1, 2014, sections 1001, 1201, 
and 1563 (relating to conforming amendments--originally 
designated as section 1562 and redesignated as section 1563 by 
section 10107(b)(1)) of Public Law 111-148 provides for 
amendments to provisions in part A. The conforming amendments 
made by section 1563 (as so redesignated) of such Public Law to 
part A take effect on date of enactment (March 23, 2010) but 
have been carried to this version to reflect to probable intent 
of Congress. Upon such date, part A of title XXVII reads as 
follows:]

              PART A--INDIVIDUAL AND GROUP MARKET REFORMS

                       Subpart I--General Reform

SEC. 2701. [300GG] FAIR HEALTH INSURANCE PREMIUMS.

    (a) \1\ Prohibiting Discriminatory Premium Rates.--
---------------------------------------------------------------------------
    \1\ There are no subsections following subsection (a) in section 
2701.
---------------------------------------------------------------------------
            (1) In general.--With respect to the premium rate 
        charged by a health insurance issuer for health 
        insurance coverage offered in the individual or small 
        group market--
                    (A) such rate shall vary with respect to 
                the particular plan or coverage involved only 
                by--
                            (i) whether such plan or coverage 
                        covers an individual or family;
                            (ii) rating area, as established in 
                        accordance with paragraph (2);
                            (iii) age, except that such rate 
                        shall not vary by more than 3 to 1 for 
                        adults (consistent with section 
                        2707(c)); and
                            (iv) tobacco use, except that such 
                        rate shall not vary by more than 1.5 to 
                        1; and
                    (B) such rate shall not vary with respect 
                to the particular plan or coverage involved by 
                any other factor not described in subparagraph 
                (A).
            (2) Rating area.--
                    (A) In general.--Each State shall establish 
                1 or more rating areas within that State for 
                purposes of applying the requirements of this 
                title.
                    (B) Secretarial review.--The Secretary 
                shall review the rating areas established by 
                each State under subparagraph (A) to ensure the 
                adequacy of such areas for purposes of carrying 
                out the requirements of this title. If the 
                Secretary determines a State's rating areas are 
                not adequate, or that a State does not 
                establish such areas, the Secretary may 
                establish rating areas for that State.
            (3) Permissible age bands.--The Secretary, in 
        consultation with the National Association of Insurance 
        Commissioners, shall define the permissible age bands 
        for rating purposes under paragraph (1)(A)(iii).
            (4) Application of variations based on age or 
        tobacco use.--With respect to family coverage under a 
        group health plan or health insurance coverage, the 
        rating variations permitted under clauses (iii) and 
        (iv) of paragraph (1)(A) shall be applied based on the 
        portion of the premium that is attributable to each 
        family member covered under the plan or coverage.
            (5) Special rule for large group market.--If a 
        State permits health insurance issuers that offer 
        coverage in the large group market in the State to 
        offer such coverage through the State Exchange (as 
        provided for under section 1312(f)(2)(B) of the Patient 
        Protection and Affordable Care Act), the provisions of 
        this subsection shall apply to all coverage offered in 
        such market (other than self-insured group health plans 
        offered in such market) in the State.

SEC. 2702. [300GG-1] GUARANTEED AVAILABILITY OF COVERAGE.

    (a) Guaranteed Issuance of Coverage in the Individual and 
Group Market.--Subject to subsections (b) through (e), each 
health insurance issuer that offers health insurance coverage 
in the individual or group market in a State must accept every 
employer and individual in the State that applies for such 
coverage.
    (b) Enrollment.--
            (1) Restriction.--A health insurance issuer 
        described in subsection (a) may restrict enrollment in 
        coverage described in such subsection to open or 
        special enrollment periods.
            (2) Establishment.--A health insurance issuer 
        described in subsection (a) shall, in accordance with 
        the regulations promulgated under paragraph (3), 
        establish special enrollment periods for qualifying 
        events (under section 603 of the Employee Retirement 
        Income Security Act of 1974).
            (3) Regulations.--The Secretary shall promulgate 
        regulations with respect to enrollment periods under 
        paragraphs (1) and (2).
    (c) Special Rules for Network Plans.--
            (1) In general.--In the case of a health insurance 
        issuer that offers health insurance coverage in the 
        group and individual market through a network plan, the 
        issuer may--
                    (A) limit the employers that may apply for 
                such coverage to those with eligible 
                individuals who live, work, or reside in the 
                service area for such network plan; and
                    (B) within the service area of such plan, 
                deny such coverage to such employers and 
                individuals if the issuer has demonstrated, if 
                required, to the applicable State authority 
                that--
                            (i) it will not have the capacity 
                        to deliver services adequately to 
                        enrollees of any additional groups or 
                        any additional individuals because of 
                        its obligations to existing group 
                        contract holders and enrollees, and
                            (ii) it is applying this paragraph 
                        uniformly to all employers and 
                        individuals without regard to the 
                        claims experience of those individuals, 
                        employers and their employees (and 
                        their dependents) or any health status-
                        related factor relating to such 
                        individuals employees and dependents.
            (2) 180-day suspension upon denial of coverage.--An 
        issuer, upon denying health insurance coverage in any 
        service area in accordance with paragraph (1)(B), may 
        not offer coverage in the group or individual market 
        within such service area for a period of 180 days after 
        the date such coverage is denied.
    (d) Application of Financial Capacity Limits.--
            (1) In general.--A health insurance issuer may deny 
        health insurance coverage in the group or individual 
        market if the issuer has demonstrated, if required, to 
        the applicable State authority that--
                    (A) it does not have the financial reserves 
                necessary to underwrite additional coverage; 
                and
                    (B) it is applying this paragraph uniformly 
                to all employers and individuals in the group 
                or individual market in the State consistent 
                with applicable State law and without regard to 
                the claims experience of those individuals, 
                employers and their employees (and their 
                dependents) or any health status-related factor 
                relating to such individuals, employees and 
                dependents.
            (2) 180-day suspension upon denial of coverage.--A 
        health insurance issuer upon denying health insurance 
        coverage in connection with group health plans in 
        accordance with paragraph (1) in a State may not offer 
        coverage in connection with group health plans in the 
        group or individual market in the State for a period of 
        180 days after the date such coverage is denied or 
        until the issuer has demonstrated to the applicable 
        State authority, if required under applicable State 
        law, that the issuer has sufficient financial reserves 
        to underwrite additional coverage, whichever is later. 
        An applicable State authority may provide for the 
        application of this subsection on a service-area-
        specific basis.

SEC. 2703. [300GG-2] GUARANTEED RENEWABILITY OF COVERAGE.

    (a) In General.--Except as provided in this section, if a 
health insurance issuer offers health insurance coverage in the 
individual or group market, the issuer must renew or continue 
in force such coverage at the option of the plan sponsor or the 
individual, as applicable.
    (b) General Exceptions.--A health insurance issuer may 
nonrenew or discontinue health insurance coverage offered in 
connection with a health insurance coverage offered in the 
group or individual market based only on one or more of the 
following:
            (1) Nonpayment of premiums.--The plan sponsor, or 
        individual, as applicable, has failed to pay premiums 
        or contributions in accordance with the terms of the 
        health insurance coverage or the issuer has not 
        received timely premium payments.
            (2) Fraud.--The plan sponsor, or individual, as 
        applicable, has performed an act or practice that 
        constitutes fraud or made an intentional 
        misrepresentation of material fact under the terms of 
        the coverage.
            (3) Violation of participation or contribution 
        rates.--In the case of a group health plan, the plan 
        sponsor has failed to comply with a material plan 
        provision relating to employer contribution or group 
        participation rules, pursuant to applicable State law.
            (4) Termination of coverage.--The issuer is ceasing 
        to offer coverage in such market in accordance with 
        subsection (c) and applicable State law.
            (5) Movement outside service area.--In the case of 
        a health insurance issuer that offers health insurance 
        coverage in the market through a network plan, there is 
        no longer any enrollee in connection with such plan who 
        lives, resides, or works in the service area of the 
        issuer (or in the area for which the issuer is 
        authorized to do business) and, in the case of the 
        small group market, the issuer would deny enrollment 
        with respect to such plan under section 2711(c)(1)(A).
            (6) Association membership ceases.--In the case of 
        health insurance coverage that is made available in the 
        small or large group market (as the case may be) only 
        through one or more bona fide associations, the 
        membership of an employer in the association (on the 
        basis of which the coverage is provided) ceases but 
        only if such coverage is terminated under this 
        paragraph uniformly without regard to any health 
        status-related factor relating to any covered 
        individual.
    (c) Requirements for Uniform Termination of Coverage.--
            (1) Particular type of coverage not offered.--In 
        any case in which an issuer decides to discontinue 
        offering a particular type of group or individual 
        health insurance coverage, coverage of such type may be 
        discontinued by the issuer in accordance with 
        applicable State law in such market only if--
                    (A) the issuer provides notice to each plan 
                sponsor or individual, as applicable, provided 
                coverage of this type in such market (and 
                participants and beneficiaries covered under 
                such coverage) of such discontinuation at least 
                90 days prior to the date of the 
                discontinuation of such coverage;
                    (B) the issuer offers to each plan sponsor 
                or individual, as applicable, provided coverage 
                of this type in such market, the option to 
                purchase all (or, in the case of the large 
                group market, any) other health insurance 
                coverage currently being offered by the issuer 
                to a group health plan or individual health 
                insurance coverage \1\ in such market; and
---------------------------------------------------------------------------
    \1\ Section 1563(c)(9)(C)(i)(III)(bb) (relating to conforming 
amendments--originally designated as section 1562 and redesignated as 
section 1563 by section 10107(b)(1)) of Public Law 111-148 provides for 
an amendment to insert ``or individual health insurance coverage''. 
Such amendment did not specify where to insert this new language, 
however, it was carried out by inserting such language after ``group 
health plan'' to reflect the probable intent of Congress.
---------------------------------------------------------------------------
                    (C) in exercising the option to discontinue 
                coverage of this type and in offering the 
                option of coverage under subparagraph (B), the 
                issuer acts uniformly without regard to the 
                claims experience of those sponsors or 
                individuals, as applicable, or any health 
                status-related factor relating to any 
                participants or beneficiaries covered or new 
                participants or beneficiaries who may become 
                eligible for such coverage.
            (2) Discontinuance of all coverage.--
                    (A) In general.--In any case in which a 
                health insurance issuer elects to discontinue 
                offering all health insurance coverage in the 
                individual or group market, or all markets, in 
                a State, health insurance coverage may be 
                discontinued by the issuer only in accordance 
                with applicable State law and if--
                            (i) the issuer provides notice to 
                        the applicable State authority and to 
                        each plan sponsor or individual, as 
                        applicable, (and participants and 
                        beneficiaries covered under such 
                        coverage) of such discontinuation at 
                        least 180 days prior to the date of the 
                        discontinuation of such coverage; and
                            (ii) all health insurance issued or 
                        delivered for issuance in the State in 
                        such market (or markets) are 
                        discontinued and coverage under such 
                        health insurance coverage in such 
                        market (or markets) is not renewed.
                    (B) Prohibition on market reentry.--In the 
                case of a discontinuation under subparagraph 
                (A) in a market, the issuer may not provide for 
                the issuance of any health insurance coverage 
                in the market and State involved during the 5-
                year period beginning on the date of the 
                discontinuation of the last health insurance 
                coverage not so renewed.
    (d) Exception for Uniform Modification of Coverage.--At the 
time of coverage renewal, a health insurance issuer may modify 
the health insurance coverage for a product offered to a group 
health plan--
            (1) in the large group market; or
            (2) in the small group market if, for coverage that 
        is available in such market other than only through one 
        or more bona fide associations, such modification is 
        consistent with State law and effective on a uniform 
        basis among group health plans with that product.
    (e) Application to Coverage Offered Only Through 
Associations.--In applying this section in the case of health 
insurance coverage that is made available by a health insurance 
issuer in the small or large group market to employers only 
through one or more associations, a reference to ``plan 
sponsor'' is deemed, with respect to coverage provided to an 
employer member of the association, to include a reference to 
such employer.

SEC. 2704. [300GG-3] PROHIBITION OF PREEXISTING CONDITION EXCLUSIONS OR 
                    OTHER DISCRIMINATION BASED ON HEALTH STATUS.

    (a) In General.--A group health plan and a health insurance 
issuer offering group or individual health insurance coverage 
may not impose any preexisting condition exclusion with respect 
to such plan or coverage.
    (b) Definitions.--For purposes of this part--
            (1) Preexisting condition exclusion.--
                    (A) In general.--The term ``preexisting 
                condition exclusion'' means, with respect to 
                coverage, a limitation or exclusion of benefits 
                relating to a condition based on the fact that 
                the condition was present before the date of 
                enrollment for such coverage, whether or not 
                any medical advice, diagnosis, care, or 
                treatment was recommended or received before 
                such date.
                    (B) Treatment of genetic information.--
                Genetic information shall not be treated as a 
                condition described in subsection (a)(1) in the 
                absence of a diagnosis of the condition related 
                to such information.
            (2) Enrollment date.--The term ``enrollment date'' 
        means, with respect to an individual covered under a 
        group health plan or health insurance coverage, the 
        date of enrollment of the individual in the plan or 
        coverage or, if earlier, the first day of the waiting 
        period for such enrollment.
            (3) Late enrollee.--The term ``late enrollee'' 
        means, with respect to coverage under a group health 
        plan, a participant or beneficiary who enrolls under 
        the plan other than during--
                    (A) the first period in which the 
                individual is eligible to enroll under the 
                plan, or
                    (B) a special enrollment period under 
                subsection (f).
            (4) Waiting period.--The term ``waiting period'' 
        means, with respect to a group health plan and an 
        individual who is a potential participant or 
        beneficiary in the plan, the period that must pass with 
        respect to the individual before the individual is 
        eligible to be covered for benefits under the terms of 
        the plan.
    (c) Rules Relating to Crediting Previous Coverage.--
            (1) Creditable coverage defined.--For purposes of 
        this title, the term ``creditable coverage'' means, 
        with respect to an individual, coverage of the 
        individual under any of the following:
                    (A) A group health plan.
                    (B) Health insurance coverage.
                    (C) Part A or part B of title XVIII of the 
                Social Security Act.
                    (D) Title XIX of the Social Security Act, 
                other than coverage consisting solely of 
                benefits under section 1928.
                    (E) Chapter 55 of title 10, United States 
                Code.
                    (F) A medical care program of the Indian 
                Health Service or of a tribal organization.
                    (G) A State health benefits risk pool.
                    (H) A health plan offered under chapter 89 
                of 
                title 5, United States Code.
                    (I) A public health plan (as defined in 
                regulations).
                    (J) A health benefit plan under section 
                5(e) of the Peace Corps Act (22 U.S.C. 
                2504(e)).
        Such term does not include coverage consisting solely 
        of coverage of excepted benefits (as defined in section 
        2791(c)).
            (2) Not counting periods before significant breaks 
        in coverage.--
                    (A) In general.--A period of creditable 
                coverage shall not be counted, with respect to 
                enrollment of an individual under a group or 
                individual health plan, if, after such period 
                and before the enrollment date, there was a 63-
                day period during all of which the individual 
                was not covered under any creditable coverage.
                    (B) Waiting period not treated as a break 
                in coverage.--For purposes of subparagraph (A) 
                and subsection (d)(4), any period that an 
                individual is in a waiting period for any 
                coverage under a group or individual health 
                plan (or for group health insurance coverage) 
                or is in an affiliation period (as defined in 
                subsection (g)(2)) shall not be taken into 
                account in determining the continuous period 
                under subparagraph (A).
                    (C) TAA-eligible individuals.--In the case 
                of plan years beginning before January 1, 
                2011--
                            (i) TAA pre-certification period 
                        rule.--In the case of a TAA-eligible 
                        individual, the period beginning on the 
                        date the individual has a TAA-related 
                        loss of coverage and ending on the date 
                        that is 7 days after the date of the 
                        issuance by the Secretary (or by any 
                        person or entity designated by the 
                        Secretary) of a qualified health 
                        insurance costs credit eligibility 
                        certificate for such individual for 
                        purposes of section 7527 of the 
                        Internal Revenue Code of 1986 shall not 
                        be taken into account in determining 
                        the continuous period under 
                        subparagraph (A).
                            (ii) Definitions.--The terms ``TAA-
                        eligible individual'' and ``TAA-related 
                        loss of coverage'' have the meanings 
                        given such terms in section 2205(b)(4).
            (3) Method of crediting coverage.--
                    (A) Standard method.--Except as otherwise 
                provided under subparagraph (B), for purposes 
                of applying subsection (a)(3), a group health 
                plan, and a health insurance issuer offering 
                group or individual health insurance coverage, 
                shall count a period of creditable coverage 
                without regard to the specific benefits covered 
                during the period.
                    (B) Election of alternative method.--A 
                group health plan, or a health insurance issuer 
                offering group or individual health insurance, 
                may elect to apply subsection (a)(3) based on 
                coverage of benefits within each of several 
                classes or categories of benefits specified in 
                regulations rather than as provided under 
                subparagraph (A). Such election shall be made 
                on a uniform basis for all participants and 
                beneficiaries. Under such election a group or 
                individual health plan or issuer shall count a 
                period of creditable coverage with respect to 
                any class or category of benefits if any level 
                of benefits is covered within such class or 
                category.
                    (C) Plan notice.--In the case of an 
                election with respect to a group health plan 
                under subparagraph (B) (whether or not health 
                insurance coverage is provided in connection 
                with such plan), the plan shall--
                            (i) prominently state in any 
                        disclosure statements concerning the 
                        plan, and state to each enrollee at the 
                        time of enrollment under the plan, that 
                        the plan has made such election, and
                            (ii) include in such statements a 
                        description of the effect of this 
                        election.
                    (D) Issuer notice.--In the case of an 
                election under subparagraph (B) with respect to 
                health insurance coverage offered by an issuer 
                in the individual or group group \1\ market, 
                the issuer--
---------------------------------------------------------------------------
    \1\ So in law. See amendment made by section 1563(c)(1)(A)(ii)(II) 
(relating to conforming amendments--originally designated as section 
1562 and redesignated as section 1563 by section 10107(b)(1)) of Public 
Law 111-148.
---------------------------------------------------------------------------
                            (i) shall prominently state in any 
                        disclosure statements concerning the 
                        coverage, and to each employer at the 
                        time of the offer or sale of the 
                        coverage, that the issuer has made such 
                        election, and
                            (ii) shall include in such 
                        statements a description of the effect 
                        of such election.
            (4) Establishment of period.--Periods of creditable 
        coverage with respect to an individual shall be 
        established through presentation of certifications 
        described in subsection (e) or in such other manner as 
        may be specified in regulations.
    (d) Exceptions.--
            (1) Exclusion not applicable to certain newborns.--
        Subject to paragraph (4), a group health plan, and a 
        health insurance issuer offering group or individual 
        health insurance coverage, may not impose any 
        preexisting condition exclusion in the case of an 
        individual who, as of the last day of the 30-day period 
        beginning with the date of birth, is covered under 
        creditable coverage.
            (2) Exclusion not applicable to certain adopted 
        children.--Subject to paragraph (4), a group health 
        plan, and a health insurance issuer offering group or 
        individual health insurance coverage, may not impose 
        any preexisting condition exclusion in the case of a 
        child who is adopted or placed for adoption before 
        attaining 18 years of age and who, as of the last day 
        of the 30-day period beginning on the date of the 
        adoption or placement for adoption, is covered under 
        creditable coverage. The previous sentence shall not 
        apply to coverage before the date of such adoption or 
        placement for adoption.
            (3) Exclusion not applicable to pregnancy.--A group 
        health plan, and health insurance issuer offering group 
        or individual health insurance coverage, may not impose 
        any preexisting condition exclusion relating to 
        pregnancy as a preexisting condition.
            (4) Loss if break in coverage.--Paragraphs (1) and 
        (2) shall no longer apply to an individual after the 
        end of the first 63-day period during all of which the 
        individual was not covered under any creditable 
        coverage.
    (e) Certifications and Disclosure of Coverage.--
            (1) Requirement for certification of period of 
        creditable coverage.--
                    (A) In general.--A group health plan, and a 
                health insurance issuer offering group or 
                individual health insurance coverage, shall 
                provide the certification described in 
                subparagraph (B)--
                            (i) at the time an individual 
                        ceases to be covered under the plan or 
                        otherwise becomes covered under a COBRA 
                        continuation provision,
                            (ii) in the case of an individual 
                        becoming covered under such a 
                        provision, at the time the individual 
                        ceases to be covered under such 
                        provision, and
                            (iii) on the request on behalf of 
                        an individual made not later than 24 
                        months after the date of cessation of 
                        the coverage described in clause (i) or 
                        (ii), whichever is later.
                The certification under clause (i) may be 
                provided, to the extent practicable, at a time 
                consistent with notices required under any 
                applicable COBRA continuation provision.
                    (B) Certification.--The certification 
                described in this subparagraph is a written 
                certification of--
                            (i) the period of creditable 
                        coverage of the individual under such 
                        plan and the coverage (if any) under 
                        such COBRA continuation provision, and
                            (ii) the waiting period (if any) 
                        (and affiliation period, if applicable) 
                        imposed with respect to the individual 
                        for any coverage under such plan.
                    (C) Issuer compliance.--To the extent that 
                medical care under a group health plan consists 
                of group health insurance coverage, the plan is 
                deemed to have satisfied the certification 
                requirement under this paragraph if the health 
                insurance issuer offering the coverage provides 
                for such certification in accordance with this 
                paragraph.
            (2) Disclosure of information on previous 
        benefits.--In the case of an election described in 
        subsection (c)(3)(B) by a group health plan or health 
        insurance issuer, if the plan or issuer enrolls an 
        individual for coverage under the plan and the 
        individual provides a certification of coverage of the 
        individual under paragraph (1)--
                    (A) upon request of such plan or issuer, 
                the entity which issued the certification 
                provided by the individual shall promptly 
                disclose to such requesting plan or issuer 
                information on coverage of classes and 
                categories of health benefits available under 
                such entity's plan or coverage, and
                    (B) such entity may charge the requesting 
                plan or issuer for the reasonable cost of 
                disclosing such information.
            (3) Regulations.--The Secretary shall establish 
        rules to prevent an entity's failure to provide 
        information under paragraph (1) or (2) with respect to 
        previous coverage of an individual from adversely 
        affecting any subsequent coverage of the individual 
        under another group health plan or health insurance 
        coverage.
    (f) Special Enrollment Periods.--
            (1) Individuals losing other coverage.--A group 
        health plan, and a health insurance issuer offering 
        group health insurance coverage in connection with a 
        group health plan, shall permit an employee who is 
        eligible, but not enrolled, for coverage under the 
        terms of the plan (or a dependent of such an employee 
        if the dependent is eligible, but not enrolled, for 
        coverage under such terms) to enroll for coverage under 
        the terms of the plan if each of the following 
        conditions is met:
                    (A) The employee or dependent was covered 
                under a group health plan or had health 
                insurance coverage at the time coverage was 
                previously offered to the employee or 
                dependent.
                    (B) The employee stated in writing at such 
                time that coverage under a group health plan or 
                health insurance coverage was the reason for 
                declining enrollment, but only if the plan 
                sponsor or issuer (if applicable) required such 
                a statement at such time and provided the 
                employee with notice of such requirement (and 
                the consequences of such requirement) at such 
                time.
                    (C) The employee's or dependent's coverage 
                described in subparagraph (A)--
                            (i) was under a COBRA continuation 
                        provision and the coverage under such 
                        provision was 
                        exhausted; or
                            (ii) was not under such a provision 
                        and either the coverage was terminated 
                        as a result of loss of eligibility for 
                        the coverage (including as a result of 
                        legal separation, divorce, death, 
                        termination of employment, or reduction 
                        in the number of hours of employment) 
                        or employer contributions toward such 
                        coverage were terminated.
                    (D) Under the terms of the plan, the 
                employee requests such enrollment not later 
                than 30 days after the date of exhaustion of 
                coverage described in subparagraph (C)(i) or 
                termination of coverage or employer 
                contribution described in subparagraph (C)(ii).
            (2) For dependent beneficiaries.--
                    (A) In general.--If--
                            (i) a group health plan makes 
                        coverage available with respect to a 
                        dependent of an individual,
                            (ii) the individual is a 
                        participant under the plan (or has met 
                        any waiting period applicable to 
                        becoming a participant under the plan 
                        and is eligible to be enrolled under 
                        the plan but for a failure to enroll 
                        during a previous enrollment period), 
                        and
                            (iii) a person becomes such a 
                        dependent of the individual through 
                        marriage, birth, or adoption or 
                        placement for adoption,
                the group health plan shall provide for a 
                dependent special enrollment period described 
                in subparagraph (B) during which the person 
                (or, if not otherwise enrolled, the individual) 
                may be enrolled under the plan as a dependent 
                of the individual, and in the case of the birth 
                or adoption of a child, the spouse of the 
                individual may be enrolled as a dependent of 
                the individual if such spouse is otherwise 
                eligible for coverage.
                    (B) Dependent special enrollment period.--A 
                dependent special enrollment period under this 
                subparagraph shall be a period of not less than 
                30 days and shall begin on the later of--
                            (i) the date dependent coverage is 
                        made 
                        available, or
                            (ii) the date of the marriage, 
                        birth, or adoption or placement for 
                        adoption (as the case may be) described 
                        in subparagraph (A)(iii).
                    (C) No waiting period.--If an individual 
                seeks to enroll a dependent during the first 30 
                days of such a dependent special enrollment 
                period, the coverage of the dependent shall 
                become effective--
                            (i) in the case of marriage, not 
                        later than the first day of the first 
                        month beginning after the date the 
                        completed request for enrollment is 
                        received;
                            (ii) in the case of a dependent's 
                        birth, as of the date of such birth; or
                            (iii) in the case of a dependent's 
                        adoption or placement for adoption, the 
                        date of such adoption or placement for 
                        adoption.
            (3) Special rules for application in case of 
        medicaid and chip.--
                    (A) In general.--A group health plan, and a 
                health insurance issuer offering group health 
                insurance coverage in connection with a group 
                health plan, shall permit an employee who is 
                eligible, but not enrolled, for coverage under 
                the terms of the plan (or a dependent of such 
                an employee if the dependent is eligible, but 
                not enrolled, for coverage under such terms) to 
                enroll for coverage under the terms of the plan 
                if either of the following conditions is met:
                            (i) Termination of medicaid or chip 
                        coverage.--The employee or dependent is 
                        covered under a Medicaid plan under 
                        title XIX of the Social Security Act or 
                        under a State child health plan under 
                        title XXI of such Act and coverage of 
                        the employee or dependent under such a 
                        plan is terminated as a result of loss 
                        of eligibility for such coverage and 
                        the employee requests coverage under 
                        the group health plan (or health 
                        insurance coverage) not later than 60 
                        days after the date of termination of 
                        such coverage.
                            (ii) Eligibility for employment 
                        assistance under medicaid or chip.--The 
                        employee or dependent becomes eligible 
                        for assistance, with respect to 
                        coverage under the group health plan or 
                        health insurance coverage, under such 
                        Medicaid plan or State child health 
                        plan (including under any waiver or 
                        demonstration project conducted under 
                        or in relation to such a plan), if the 
                        employee requests coverage under the 
                        group health plan or health insurance 
                        coverage not later than 60 days after 
                        the date the employee or dependent is 
                        determined to be eligible for such 
                        assistance.
                    (B) Coordination with medicaid and chip.--
                            (i) Outreach to employees regarding 
                        availability of medicaid and chip 
                        coverage.--
                                    (I) In general.--Each 
                                employer that maintains a group 
                                health plan in a State that 
                                provides medical assistance 
                                under a State Medicaid plan 
                                under title XIX of the Social 
                                Security Act, or child health 
                                assistance under a State child 
                                health plan under title XXI of 
                                such Act, in the form of 
                                premium assistance for the 
                                purchase of coverage under a 
                                group health plan, shall 
                                provide to each employee a 
                                written notice informing the 
                                employee of potential 
                                opportunities then currently 
                                available in the State in which 
                                the employee resides for 
                                premium assistance under such 
                                plans for health coverage of 
                                the employee or the employee's 
                                dependents. For purposes of 
                                compliance with this subclause, 
                                the employer may use any State-
                                specific model notice developed 
                                in accordance with section 
                                701(f)(3)(B)(i)(II) of the 
                                Employee Retirement Income 
                                Security Act of 1974 (29 U.S.C. 
                                1181(f)(3)(B)(i)(II)).
                                    (II) Option to provide 
                                concurrent with provision of 
                                plan materials to employee.--An 
                                employer may provide the model 
                                notice applicable to the State 
                                in which an employee resides 
                                concurrent with the furnishing 
                                of materials notifying the 
                                employee of health plan 
                                eligibility, concurrent with 
                                materials provided to the 
                                employee in connection with an 
                                open season or election process 
                                conducted under the plan, or 
                                concurrent with the furnishing 
                                of the summary plan description 
                                as provided in section 104(b) 
                                of the Employee Retirement 
                                Income Security Act of 1974.
                            (ii) Disclosure about group health 
                        plan benefits to states for medicaid 
                        and chip eligible individuals.--In the 
                        case of an enrollee in a group health 
                        plan who is covered under a Medicaid 
                        plan of a State under title XIX of the 
                        Social Security Act or under a State 
                        child health plan under title XXI of 
                        such Act, the plan administrator of the 
                        group health plan shall disclose to the 
                        State, upon request, information about 
                        the benefits available under the group 
                        health plan in sufficient specificity, 
                        as determined under regulations of the 
                        Secretary of Health and Human Services 
                        in consultation with the Secretary that 
                        require use of the model coverage 
                        coordination disclosure form developed 
                        under section 311(b)(1)(C) of the 
                        Children's Health Insurance 
                        Reauthorization Act of 2009, so as to 
                        permit the State to make a 
                        determination (under paragraph (2)(B), 
                        (3), or (10) of section 2105(c) of the 
                        Social Security Act or otherwise) 
                        concerning the cost-effectiveness of 
                        the State providing medical or child 
                        health assistance through premium 
                        assistance for the purchase of coverage 
                        under such group health plan and in 
                        order for the State to provide 
                        supplemental benefits required under 
                        paragraph (10)(E) of such section or 
                        other authority.
    (g) Use of Affiliation Period by HMOs as Alternative to 
Preexisting Condition Exclusion.--
            (1) In general.--A health maintenance organization 
        which offers health insurance coverage in connection 
        with a group health plan and which does not impose any 
        preexisting condition exclusion allowed under 
        subsection (a) with respect to any particular coverage 
        option may impose an affiliation period for such 
        coverage option, but only if--
                    (A) such period is applied uniformly 
                without regard to any health status-related 
                factors; and
                    (B) such period does not exceed 2 months 
                (or 3 months in the case of a late enrollee).
            (2) Affiliation period.--
                    (A) Defined.--For purposes of this title, 
                the term ``affiliation period'' means a period 
                which, under the terms of the health insurance 
                coverage offered by the health maintenance 
                organization, must expire before the health 
                insurance coverage becomes effective. The 
                organization is not required to provide health 
                care services or benefits during such period 
                and no premium shall be charged to the 
                participant or beneficiary for any coverage 
                during the period.
                    (B) Beginning.--Such period shall begin on 
                the enrollment date.
                    (C) Runs concurrently with waiting 
                periods.--An affiliation period under a plan 
                shall run concurrently with any waiting period 
                under the plan.
            (3) Alternative methods.--A health maintenance 
        organization described in paragraph (1) may use 
        alternative methods, from those described in such 
        paragraph, to address adverse selection as approved by 
        the State insurance commissioner or official or 
        officials designated by the State to enforce the 
        requirements of this part for the State involved with 
        respect to such issuer.

SEC. 2705. [300GG-4] PROHIBITING DISCRIMINATION AGAINST INDIVIDUAL 
                    PARTICIPANTS AND BENEFICIARIES BASED ON HEALTH 
                    STATUS.

    (a) In General.--A group health plan and a health insurance 
issuer offering group or individual health insurance coverage 
may not establish rules for eligibility (including continued 
eligibility) of any individual to enroll under the terms of the 
plan or coverage based on any of the following health status-
related factors in relation to the individual or a dependent of 
the individual:
            (1) Health status.
            (2) Medical condition (including both physical and 
        mental illnesses).
            (3) Claims experience.
            (4) Receipt of health care.
            (5) Medical history.
            (6) Genetic information.
            (7) Evidence of insurability (including conditions 
        arising out of acts of domestic violence).
            (8) Disability.
            (9) Any other health status-related factor 
        determined appropriate by the Secretary.
    (b) In Premium Contributions.--
            (1) In general.--A group health plan, and a health 
        insurance issuer offering group or individual health 
        insurance coverage, may not require any individual (as 
        a condition of enrollment or continued enrollment under 
        the plan) to pay a premium or contribution which is 
        greater than such premium or contribution for a 
        similarly situated individual enrolled in the plan on 
        the basis of any health status-related factor in 
        relation to the individual or to an individual enrolled 
        under the plan as a dependent of the individual.
            (2) Construction.--Nothing in paragraph (1) shall 
        be construed--
                    (A) to restrict the amount that an employer 
                or individual may be charged for coverage under 
                a group health plan except as provided in 
                paragraph (3) or individual health coverage, as 
                the case may be; or
                    (B) to prevent a group health plan, and a 
                health insurance issuer offering group health 
                insurance coverage, from establishing premium 
                discounts or rebates or modifying otherwise 
                applicable copayments or deductibles in return 
                for adherence to programs of health promotion 
                and disease prevention.
            (3) No group-based discrimination on basis of 
        genetic information.--
                    (A) In general.--For purposes of this 
                section, a group health plan, and health 
                insurance issuer offering group or individual 
                health insurance coverage, may not adjust 
                premium or contribution amounts for the group 
                covered under such plan on the basis of genetic 
                information.
                    (B) Rule of construction.--Nothing in 
                subparagraph (A) or in paragraphs (1) and (2) 
                of subsection (d) shall be construed to limit 
                the ability of a health insurance issuer 
                offering group or individual health insurance 
                coverage to increase the premium for an 
                employer based on the manifestation of a 
                disease or disorder of an individual who is 
                enrolled in the plan. In such case, the 
                manifestation of a disease or disorder in one 
                individual cannot also be used as genetic 
                information about other group members and to 
                further increase the premium for the employer.
    (c) Genetic Testing.--
            (1) Limitation on requesting or requiring genetic 
        testing.--A group health plan, and a health insurance 
        issuer offering health insurance coverage in connection 
        with a group health plan, shall not request or require 
        an individual or a family member of such individual to 
        undergo a genetic test.
            (2) Rule of construction.--Paragraph (1) shall not 
        be construed to limit the authority of a health care 
        professional who is providing health care services to 
        an individual to request that such individual undergo a 
        genetic test.
            (3) Rule of construction regarding payment.--
                    (A) In general.--Nothing in paragraph (1) 
                shall be construed to preclude a group health 
                plan, or a health insurance issuer offering 
                health insurance coverage in connection with a 
                group health plan, from obtaining and using the 
                results of a genetic test in making a 
                determination regarding payment (as such term 
                is defined for the purposes of applying the 
                regulations promulgated by the Secretary under 
                part C of title XI of the Social Security Act 
                and section 264 of the Health Insurance 
                Portability and Accountability Act of 1996, as 
                may be revised from time to time) consistent 
                with subsection (a).
                    (B) Limitation.--For purposes of 
                subparagraph (A), a group health plan, or a 
                health insurance issuer offering health 
                insurance coverage in connection with a group 
                health plan, may request only the minimum 
                amount of information necessary to accomplish 
                the intended purpose.
            (4) Research exception.--Notwithstanding paragraph 
        (1), a group health plan, or a health insurance issuer 
        offering health insurance coverage in connection with a 
        group health plan, may request, but not require, that a 
        participant or beneficiary undergo a genetic test if 
        each of the following conditions is met:
                    (A) The request is made pursuant to 
                research that complies with part 46 of title 
                45, Code of Federal Regulations, or equivalent 
                Federal regulations, and any applicable State 
                or local law or regulations for the protection 
                of human subjects in research.
                    (B) The plan or issuer clearly indicates to 
                each participant or beneficiary, or in the case 
                of a minor child, to the legal guardian of such 
                beneficiary, to whom the request is made that--
                            (i) compliance with the request is 
                        voluntary; and
                            (ii) non-compliance will have no 
                        effect on enrollment status or premium 
                        or contribution amounts.
                    (C) No genetic information collected or 
                acquired under this paragraph shall be used for 
                underwriting purposes.
                    (D) The plan or issuer notifies the 
                Secretary in writing that the plan or issuer is 
                conducting activities pursuant to the exception 
                provided for under this paragraph, including a 
                description of the activities conducted.
                    (E) The plan or issuer complies with such 
                other conditions as the Secretary may by 
                regulation require for activities conducted 
                under this paragraph.
    (d) Prohibition on Collection of Genetic Information.--
            (1) In general.--A group health plan, and a health 
        insurance issuer offering health insurance coverage in 
        connection with a group health plan, shall not request, 
        require, or purchase genetic information for 
        underwriting purposes (as defined in section 2791).
            (2) Prohibition on collection of genetic 
        information prior to enrollment.--A group health plan, 
        and a health insurance issuer offering health insurance 
        coverage in connection with a group health plan, shall 
        not request, require, or purchase genetic information 
        with respect to any individual prior to such 
        individual's enrollment under the plan or coverage in 
        connection with such enrollment.
            (3) Incidental collection.--If a group health plan, 
        or a health insurance issuer offering health insurance 
        coverage in connection with a group health plan, 
        obtains genetic information incidental to the 
        requesting, requiring, or purchasing of other 
        information concerning any individual, such request, 
        requirement, or purchase shall not be considered a 
        violation of paragraph (2) if such request, 
        requirement, or purchase is not in violation of 
        paragraph (1).
    (e) Application to All Plans.--The provisions of 
subsections (a)(6), (b)(3), (c), and (d) and subsection (b)(1) 
and section 2704 with respect to genetic information, shall 
apply to group health plans and health insurance issuers 
without regard to section 2735(a).
    (f) Genetic Information of a Fetus or Embryo.--Any 
reference in this part to genetic information concerning an 
individual or family member of an individual shall--
            (1) with respect to such an individual or family 
        member of an individual who is a pregnant woman, 
        include genetic information of any fetus carried by 
        such pregnant woman; and
            (2) with respect to an individual or family member 
        utilizing an assisted reproductive technology, include 
        genetic information of any embryo legally held by the 
        individual or family member.
    (j) \1\ Programs of Health Promotion or Disease 
Prevention.--
---------------------------------------------------------------------------
    \1\ So in law. There are no subsections (g)-(i).
---------------------------------------------------------------------------
            (1) General provisions.--
                    (A) General rule.--For purposes of 
                subsection (b)(2)(B), a program of health 
                promotion or disease prevention (referred to in 
                this subsection as a ``wellness program'') 
                shall be a program offered by an employer that 
                is designed to promote health or prevent 
                disease that meets the applicable requirements 
                of this subsection.
                    (B) No conditions based on health status 
                factor.--If none of the conditions for 
                obtaining a premium discount or rebate or other 
                reward for participation in a wellness program 
                is based on an individual satisfying a standard 
                that is related to a health status factor, such 
                wellness program shall not violate this section 
                if participation in the program is made 
                available to all similarly situated individuals 
                and the requirements of paragraph (2) are 
                complied with.
                    (C) Conditions based on health status 
                factor.--If any of the conditions for obtaining 
                a premium discount or rebate or other reward 
                for participation in a wellness program is 
                based on an individual satisfying a standard 
                that is related to a health status factor, such 
                wellness program shall not violate this section 
                if the requirements of paragraph (3) are 
                complied with.
            (2) Wellness programs not subject to 
        requirements.--If none of the conditions for obtaining 
        a premium discount or rebate or other reward under a 
        wellness program as described in paragraph (1)(B) are 
        based on an individual satisfying a standard that is 
        related to a health status factor (or if such a 
        wellness program does not provide such a reward), the 
        wellness program shall not violate this section if 
        participation in the program is made available to all 
        similarly situated individuals. The following programs 
        shall not have to comply with the requirements of 
        paragraph (3) if participation in the program is made 
        available to all similarly situated individuals:
                    (A) A program that reimburses all or part 
                of the cost for memberships in a fitness 
                center.
                    (B) A diagnostic testing program that 
                provides a reward for participation and does 
                not base any part of the reward on outcomes.
                    (C) A program that encourages preventive 
                care related to a health condition through the 
                waiver of the copayment or deductible 
                requirement under group health plan for the 
                costs of certain items or services related to a 
                health condition (such as prenatal care or 
                well-baby visits).
                    (D) A program that reimburses individuals 
                for the costs of smoking cessation programs 
                without regard to whether the individual quits 
                smoking.
                    (E) A program that provides a reward to 
                individuals for attending a periodic health 
                education seminar.
            (3) Wellness programs subject to requirements.--If 
        any of the conditions for obtaining a premium discount, 
        rebate, or reward under a wellness program as described 
        in paragraph (1)(C) is based on an individual 
        satisfying a standard that is related to a health 
        status factor, the wellness program shall not violate 
        this section if the following requirements are complied 
        with:
                    (A) The reward for the wellness program, 
                together with the reward for other wellness 
                programs with respect to the plan that requires 
                satisfaction of a standard related to a health 
                status factor, shall not exceed 30 percent of 
                the cost of employee-only coverage under the 
                plan. If, in addition to employees or 
                individuals, any class of dependents (such as 
                spouses or spouses and dependent children) may 
                participate fully in the wellness program, such 
                reward shall not exceed 30 percent of the cost 
                of the coverage in which an employee or 
                individual and any dependents are enrolled. For 
                purposes of this paragraph, the cost of 
                coverage shall be determined based on the total 
                amount of employer and employee contributions 
                for the benefit package under which the 
                employee is (or the employee and any dependents 
                are) receiving coverage. A reward may be in the 
                form of a discount or rebate of a premium or 
                contribution, a waiver of all or part of a 
                cost-sharing mechanism (such as deductibles, 
                copayments, or coinsurance), the absence of a 
                surcharge, or the value of a benefit that would 
                otherwise not be provided under the plan. The 
                Secretaries of Labor, Health and Human 
                Services, and the Treasury may increase the 
                reward available under this subparagraph to up 
                to 50 percent of the cost of coverage if the 
                Secretaries determine that such an increase is 
                appropriate.
                    (B) The wellness program shall be 
                reasonably designed to promote health or 
                prevent disease. A program complies with the 
                preceding sentence if the program has a 
                reasonable chance of improving the health of, 
                or preventing disease in, participating 
                individuals and it is not overly burdensome, is 
                not a subterfuge for discriminating based on a 
                health status factor, and is not highly suspect 
                in the method chosen to promote health or 
                prevent disease.
                    (C) The plan shall give individuals 
                eligible for the program the opportunity to 
                qualify for the reward under the program at 
                least once each year.
                    (D) The full reward under the wellness 
                program shall be made available to all 
                similarly situated individuals. For such 
                purpose, among other things:
                            (i) The reward is not available to 
                        all similarly situated individuals for 
                        a period unless the wellness program 
                        allows--
                                    (I) for a reasonable 
                                alternative standard (or waiver 
                                of the otherwise applicable 
                                standard) for obtaining the 
                                reward for any individual for 
                                whom, for that period, it is 
                                unreasonably difficult due to a 
                                medical condition to satisfy 
                                the otherwise applicable 
                                standard; and
                                    (II) for a reasonable 
                                alternative standard (or waiver 
                                of the otherwise applicable 
                                standard) for obtaining the 
                                reward for any individual for 
                                whom, for that period, it is 
                                medically inadvisable to 
                                attempt to satisfy the 
                                otherwise applicable standard.
                            (ii) If reasonable under the 
                        circumstances, the plan or issuer may 
                        seek verification, such as a statement 
                        from an individual's physician, that a 
                        health status factor makes it 
                        unreasonably difficult or medically 
                        inadvisable for the individual to 
                        satisfy or attempt to satisfy the 
                        otherwise applicable standard.
                    (E) The plan or issuer involved shall 
                disclose in all plan materials describing the 
                terms of the wellness program the availability 
                of a reasonable alternative standard (or the 
                possibility of waiver of the otherwise 
                applicable standard) required under 
                subparagraph (D). If plan materials disclose 
                that such a program is available, without 
                describing its terms, the disclosure under this 
                subparagraph shall not be required.
    (k) Existing Programs.--Nothing in this section shall 
prohibit a program of health promotion or disease prevention 
that was established prior to the date of enactment of this 
section and applied with all applicable regulations, and that 
is operating on such date, from continuing to be carried out 
for as long as such regulations remain in effect.
    (l) Wellness Program Demonstration Project.--
            (1) In general.--Not later than July 1, 2014, the 
        Secretary, in consultation with the Secretary of the 
        Treasury and the Secretary of Labor, shall establish a 
        10-State demonstration project under which 
        participating States shall apply the provisions of 
        subsection (j) to programs of health promotion offered 
        by a health insurance issuer that offers health 
        insurance coverage in the individual market in such 
        State.
            (2) Expansion of demonstration project.--If the 
        Secretary, in consultation with the Secretary of the 
        Treasury and the Secretary of Labor, determines that 
        the demonstration project described in paragraph (1) is 
        effective, such Secretaries may, beginning on July 1, 
        2017 expand such demonstration project to include 
        additional participating States.
            (3) Requirements.--
                    (A) Maintenance of coverage.--The 
                Secretary, in consultation with the Secretary 
                of the Treasury and the Secretary of Labor, 
                shall not approve the participation of a State 
                in the demonstration project under this section 
                unless the Secretaries determine that the 
                State's project is designed in a manner that--
                            (i) will not result in any decrease 
                        in coverage; and
                            (ii) will not increase the cost to 
                        the Federal Government in providing 
                        credits under section 36B of the 
                        Internal Revenue Code of 1986 or cost-
                        sharing assistance under section 1402 
                        of the Patient Protection and 
                        Affordable Care Act.
                    (B) Other requirements.--States that 
                participate in the demonstration project under 
                this subsection--
                            (i) may permit premium discounts or 
                        rebates or the modification of 
                        otherwise applicable copayments or 
                        deductibles for adherence to, or 
                        participation in, a reasonably designed 
                        program of health promotion and disease 
                        prevention;
                            (ii) shall ensure that requirements 
                        of consumer protection are met in 
                        programs of health promotion in the 
                        individual market;
                            (iii) shall require verification 
                        from health insurance issuers that 
                        offer health insurance coverage in the 
                        individual market of such State that 
                        premium discounts--
                                    (I) do not create undue 
                                burdens for individuals insured 
                                in the individual market;
                                    (II) do not lead to cost 
                                shifting; and
                                    (III) are not a subterfuge 
                                for discrimination;
                            (iv) shall ensure that consumer 
                        data is protected in accordance with 
                        the requirements of section 264(c) of 
                        the Health Insurance Portability and 
                        Accountability Act of 1996 (42 U.S.C. 
                        1320d-2 note); and
                            (v) shall ensure and demonstrate to 
                        the satisfaction of the Secretary that 
                        the discounts or other rewards provided 
                        under the project reflect the expected 
                        level of participation in the wellness 
                        program involved and the anticipated 
                        effect the program will have on 
                        utilization or medical claim costs.
    (m) Report.--
            (1) In general.--Not later than 3 years after the 
        date of enactment of the Patient Protection and 
        Affordable Care Act, the Secretary, in consultation 
        with the Secretary of the Treasury and the Secretary of 
        Labor, shall submit a report to the appropriate 
        committees of Congress concerning--
                    (A) the effectiveness of wellness programs 
                (as defined in subsection (j)) in promoting 
                health and preventing disease;
                    (B) the impact of such wellness programs on 
                the access to care and affordability of 
                coverage for participants and non-participants 
                of such programs;
                    (C) the impact of premium-based and cost-
                sharing incentives on participant behavior and 
                the role of such programs in changing behavior; 
                and
                    (D) the effectiveness of different types of 
                rewards.
            (2) Data collection.--In preparing the report 
        described in paragraph (1), the Secretaries shall 
        gather relevant information from employers who provide 
        employees with access to wellness programs, including 
        State and Federal agencies.
    (n) Regulations.--Nothing in this section shall be 
construed as prohibiting the Secretaries of Labor, Health and 
Human Services, or the Treasury from promulgating regulations 
in connection with this section.

SEC. 2706. [300GG-5] NON-DISCRIMINATION IN HEALTH CARE.

    (a) Providers.--A group health plan and a health insurance 
issuer offering group or individual health insurance coverage 
shall not discriminate with respect to participation under the 
plan or coverage against any health care provider who is acting 
within the scope of that provider's license or certification 
under applicable State law. This section shall not require that 
a group health plan or health insurance issuer contract with 
any health care provider willing to abide by the terms and 
conditions for participation established by the plan or issuer. 
Nothing in this section shall be construed as preventing a 
group health plan, a health insurance issuer, or the Secretary 
from establishing varying reimbursement rates based on quality 
or performance measures.
    (b) Individuals.--The provisions of section 1558 of the 
Patient Protection and Affordable Care Act (relating to non-
discrimination) shall apply with respect to a group health plan 
or health insurance issuer offering group or individual health 
insurance coverage.

SEC. 2707. [300GG-6] COMPREHENSIVE HEALTH INSURANCE COVERAGE.

    (a) Coverage for Essential Health Benefits Package.--A 
health insurance issuer that offers health insurance coverage 
in the individual or small group market shall ensure that such 
coverage includes the essential health benefits package 
required under section 1302(a) of the Patient Protection and 
Affordable Care Act.
    (b) Cost-sharing Under Group Health Plans.--A group health 
plan shall ensure that any annual cost-sharing imposed under 
the plan does not exceed the limitations provided for under 
paragraphs (1) and (2) of section 1302(c).
    (c) Child-only Plans.--If a health insurance issuer offers 
health insurance coverage in any level of coverage specified 
under section 1302(d) of the Patient Protection and Affordable 
Care Act, the issuer shall also offer such coverage in that 
level as a plan in which the only enrollees are individuals 
who, as of the beginning of a plan year, have not attained the 
age of 21.
    (d) Dental Only.--This section shall not apply to a plan 
described in section 1302(d)(2)(B)(ii)(I).

SEC. 2708. [300GG-7] PROHIBITION ON EXCESSIVE WAITING PERIODS.

    A group health plan and a health insurance issuer offering 
group health insurance coverage shall not apply any waiting 
period (as defined in section 2704(b)(4)) that exceeds 90 days.

SEC. 2709. [300GG-8] COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED 
                    CLINICAL TRIALS. \1\
---------------------------------------------------------------------------

    \1\ So in law. There are two section 2709's. The first section 2709 
(relating Disclosure of Information), was former section 2713, which 
was then redesignated as 2733 (by section 1001(3) of Public Law 111-
148), then redesignated again to section 2709 and transfered to appear 
after section 2708 (by section 1563(c)(10)(C) (relating to conforming 
amendments--originally designated as section 1562 and redesignated as 
section 1563 by section 10107(b)(1)) of such Public Law).
---------------------------------------------------------------------------
    (a) Coverage.--
            (1) In general.--If a group health plan or a health 
        insurance issuer offering group or individual health 
        insurance coverage provides coverage to a qualified 
        individual, then such plan or issuer--
                    (A) may not deny the individual 
                participation in the clinical trial referred to 
                in subsection (b)(2);
                    (B) subject to subsection (c), may not deny 
                (or limit or impose additional conditions on) 
                the coverage of routine patient costs for items 
                and services furnished in connection with 
                participation in the trial; and
                    (C) may not discriminate against the 
                individual on the basis of the individual's 
                participation in such trial.
            (2) Routine patient costs.--
                    (A) Inclusion.--For purposes of paragraph 
                (1)(B), subject to subparagraph (B), routine 
                patient costs include all items and services 
                consistent with the coverage provided in the 
                plan (or coverage) that is typically covered 
                for a qualified individual who is not enrolled 
                in a clinical trial.
                    (B) Exclusion.--For purposes of paragraph 
                (1)(B), routine patient costs does not 
                include--
                            (i) the investigational item, 
                        device, or service, itself;
                            (ii) items and services that are 
                        provided solely to satisfy data 
                        collection and analysis needs and that 
                        are not used in the direct clinical 
                        management of the patient; or
                            (iii) a service that is clearly 
                        inconsistent with widely accepted and 
                        established standards of care for a 
                        particular diagnosis.
            (3) Use of in-network providers.--If one or more 
        participating providers is participating in a clinical 
        trial, nothing in paragraph (1) shall be construed as 
        preventing a plan or issuer from requiring that a 
        qualified individual participate in the trial through 
        such a participating provider if the provider will 
        accept the individual as a participant in the trial.
            (4) Use of out-of-network.--Notwithstanding 
        paragraph (3), paragraph (1) shall apply to a qualified 
        individual participating in an approved clinical trial 
        that is conducted outside the State in which the 
        qualified individual resides.
    (b) Qualified Individual Defined.--For purposes of 
subsection (a), the term ``qualified individual'' means an 
individual who is a participant or beneficiary in a health plan 
or with coverage described in subsection (a)(1) and who meets 
the following conditions:
            (1) The individual is eligible to participate in an 
        approved clinical trial according to the trial protocol 
        with respect to treatment of cancer or other life-
        threatening disease or condition.
            (2) Either--
                    (A) the referring health care professional 
                is a participating health care provider and has 
                concluded that the individual's participation 
                in such trial would be appropriate based upon 
                the individual meeting the conditions described 
                in paragraph (1); or
                    (B) the participant or beneficiary provides 
                medical and scientific information establishing 
                that the individual's participation in such 
                trial would be appropriate based upon the 
                individual meeting the conditions described in 
                paragraph (1).
    (c) Limitations on Coverage.--This section shall not be 
construed to require a group health plan, or a health insurance 
issuer offering group or individual health insurance coverage, 
to provide benefits for routine patient care services provided 
outside of the plan's (or coverage's) health care provider 
network unless out-of-network benefits are otherwise provided 
under the plan (or coverage).
    (d) Approved Clinical Trial Defined.--
            (1) In general.--In this section, the term 
        ``approved clinical trial'' means a phase I, phase II, 
        phase III, or phase IV clinical trial that is conducted 
        in relation to the prevention, detection, or treatment 
        of cancer or other life-threatening disease or 
        condition and is described in any of the following 
        subparagraphs:
                    (A) Federally funded trials.--The study or 
                investigation is approved or funded (which may 
                include funding through in-kind contributions) 
                by one or more of the following:
                            (i) The National Institutes of 
                        Health.
                            (ii) The Centers for Disease 
                        Control and Prevention.
                            (iii) The Agency for Health Care 
                        Research and Quality.
                            (iv) The Centers for Medicare & 
                        Medicaid Services.
                            (v) cooperative group or center of 
                        any of the entities described in 
                        clauses (i) through (iv) or the 
                        Department of Defense or the Department 
                        of Veterans Affairs.
                            (vi) A qualified non-governmental 
                        research entity identified in the 
                        guidelines issued by the National 
                        Institutes of Health for center support 
                        grants.
                            (vii) Any of the following if the 
                        conditions described in paragraph (2) 
                        are met:
                                    (I) The Department of 
                                Veterans Affairs.
                                    (II) The Department of 
                                Defense.
                                    (III) The Department of 
                                Energy.
                    (B) The study or investigation is conducted 
                under an investigational new drug application 
                reviewed by the Food and Drug Administration.
                    (C) The study or investigation is a drug 
                trial that is exempt from having such an 
                investigational new drug application.
            (2) Conditions for departments.--The conditions 
        described in this paragraph, for a study or 
        investigation conducted by a Department, are that the 
        study or investigation has been reviewed and approved 
        through a system of peer review that the Secretary 
        determines--
                    (A) to be comparable to the system of peer 
                review of studies and investigations used by 
                the National Institutes of Health, and
                    (B) assures unbiased review of the highest 
                scientific standards by qualified individuals 
                who have no interest in the outcome of the 
                review.
    (e) Life-threatening Condition Defined.--In this section, 
the term ``life-threatening condition'' means any disease or 
condition from which the likelihood of death is probable unless 
the course of the disease or condition is interrupted.
    (f) Construction.--Nothing in this section shall be 
construed to limit a plan's or issuer's coverage with respect 
to clinical trials.
    (g) Application to FEHBP.--Notwithstanding any provision of 
chapter 89 of title 5, United States Code, this section shall 
apply to health plans offered under the program under such 
chapter.
    (h) Preemption.--Notwithstanding any other provision of 
this Act, nothing in this section shall preempt State laws that 
require a clinical trials policy for State regulated health 
insurance plans that is in addition to the policy required 
under this section.

SEC. 2709. [300GG-9] DISCLOSURE OF INFORMATION.

    (a) Disclosure of Information by Health Plan Issuers.--In 
connection with the offering of any health insurance coverage 
to a small employer or an individual, a health insurance 
issuer--
            (1) shall make a reasonable disclosure to such 
        employer,, \1\ or individual, as applicable, as part of 
        its solicitation and sales materials, of the 
        availability of information described in subsection 
        (b), and
---------------------------------------------------------------------------
    \1\ So in law.
---------------------------------------------------------------------------
            (2) upon request of such a employer, or individual, 
        as applicable,, \1\ or individual, as applicable, 
        provide such information.
    (b) Information Described.--
            (1) In general.--Subject to paragraph (3), with 
        respect to a health insurance issuer offering health 
        insurance coverage to a employer, or individual, as 
        applicable,, \1\ information described in this 
        subsection is information concerning--
                    (A) the provisions of such coverage 
                concerning issuer's right to change premium 
                rates and the factors that may affect changes 
                in premium rates; and
                    (B) the benefits and premiums available 
                under all health insurance coverage for which 
                the employer, or individual, as applicable, is 
                qualified.
            (2) Form of information.--Information under this 
        subsection shall be provided to employers, or 
        individuals, as applicable, in a manner determined to 
        be understandable by the average employer, or 
        individual, as applicable,, \1\ and shall be sufficient 
        to reasonably inform employers, or individuals, as 
        applicable, of their rights and obligations under the 
        health insurance coverage.
---------------------------------------------------------------------------
    \1\ So in law.
---------------------------------------------------------------------------
            (3) Exception.--An issuer is not required under 
        this section to disclose any information that is 
        proprietary and trade secret information under 
        applicable law.

                     Subpart II--Improving Coverage

SEC. 2711. [300GG-11] NO LIFETIME OR ANNUAL LIMITS.

    (a) Prohibition.--
            (1) In general.--A group health plan and a health 
        insurance issuer offering group or individual health 
        insurance coverage may not establish--
                    (A) lifetime limits on the dollar value of 
                benefits for any participant or beneficiary; or
                    (B) except as provided in paragraph (2), 
                annual limits on the dollar value of benefits 
                for any participant or beneficiary.
            (2) Annual limits prior to 2014.--With respect to 
        plan years beginning prior to January 1, 2014, a group 
        health plan and a health insurance issuer offering 
        group or individual health insurance coverage may only 
        establish a restricted annual limit on the dollar value 
        of benefits for any participant or beneficiary with 
        respect to the scope of benefits that are essential 
        health benefits under section 1302(b) of the Patient 
        Protection and Affordable Care Act, as determined by 
        the Secretary. In defining the term ``restricted annual 
        limit'' for purposes of the preceding sentence, the 
        Secretary shall ensure that access to needed services 
        is made available with a minimal impact on premiums.
    (b) Per Beneficiary Limits.--Subsection (a) shall not be 
construed to prevent a group health plan or health insurance 
coverage from placing annual or lifetime per beneficiary limits 
on specific covered benefits that are not essential health 
benefits under section 1302(b) of the Patient Protection and 
Affordable Care Act, to the extent that such limits are 
otherwise permitted under Federal or State law.

SEC. 2712. [300GG-12] PROHIBITION ON RESCISSIONS.

    A group health plan and a health insurance issuer offering 
group or individual health insurance coverage shall not rescind 
such plan or coverage with respect to an enrollee once the 
enrollee is covered under such plan or coverage involved, 
except that this section shall not apply to a covered 
individual who has performed an act or practice that 
constitutes fraud or makes an intentional misrepresentation of 
material fact as prohibited by the terms of the plan or 
coverage. Such plan or coverage may not be cancelled except 
with prior notice to the enrollee, and only as permitted under 
section 2702(c) or 2742(b).

SEC. 2713. [300GG-13] COVERAGE OF PREVENTIVE HEALTH SERVICES.

    (a) In General.--A group health plan and a health insurance 
issuer offering group or individual health insurance coverage 
shall, at a minimum provide coverage for and shall not impose 
any cost sharing requirements for--
            (1) evidence-based items or services that have in 
        effect a rating of ``A'' or ``B'' in the current 
        recommendations of the United States Preventive 
        Services Task Force;
            (2) immunizations that have in effect a 
        recommendation from the Advisory Committee on 
        Immunization Practices of the Centers for Disease 
        Control and Prevention with respect to the individual 
        involved; and
            (3) with respect to infants, children, and 
        adolescents, evidence-informed preventive care and 
        screenings provided for in the comprehensive guidelines 
        supported by the Health Resources and Services 
        Administration.
            (4) with respect to women, such additional 
        preventive care and screenings not described in 
        paragraph (1) as provided for in comprehensive 
        guidelines supported by the Health Resources and 
        Services Administration for purposes of this paragraph.
            (5) for the purposes of this Act, and for the 
        purposes of any other provision of law, the current 
        recommendations of the United States Preventive Service 
        Task Force regarding breast cancer screening, 
        mammography, and prevention shall be considered the 
        most current other than those issued in or around 
        November 2009.
Nothing in this subsection shall be construed to prohibit a 
plan or issuer from providing coverage for services in addition 
to those recommended by United States Preventive Services Task 
Force or to deny coverage for services that are not recommended 
by such Task Force.
    (b) Interval.--
            (1) In general.--The Secretary shall establish a 
        minimum interval between the date on which a 
        recommendation described in subsection (a)(1) or (a)(2) 
        or a guideline under subsection (a)(3) is issued and 
        the plan year with respect to which the requirement 
        described in subsection (a) is effective with respect 
        to the service described in such recommendation or 
        guideline.
            (2) Minimum.--The interval described in paragraph 
        (1) shall not be less than 1 year.
    (c) Value-based Insurance Design.--The Secretary may 
develop guidelines to permit a group health plan and a health 
insurance issuer offering group or individual health insurance 
coverage to utilize value-based insurance designs.

SEC. 2714. [300GG-14] EXTENSION OF DEPENDENT COVERAGE.

    (a) In General.--A group health plan and a health insurance 
issuer offering group or individual health insurance coverage 
that provides dependent coverage of children shall continue to 
make such coverage available for an adult child until the child 
turns 26 years of age. Nothing in this section shall require a 
health plan or a health insurance issuer described in the 
preceding sentence to make coverage available for a child of a 
child receiving dependent coverage.
    (b) Regulations.--The Secretary shall promulgate 
regulations to define the dependents to which coverage shall be 
made available under subsection (a).
    (c) Rule of Construction.--Nothing in this section shall be 
construed to modify the definition of ``dependent'' as used in 
the Internal Revenue Code of 1986 with respect to the tax 
treatment of the cost of coverage.

SEC. 2715. [300GG-15] DEVELOPMENT AND UTILIZATION OF UNIFORM 
                    EXPLANATION OF COVERAGE DOCUMENTS AND STANDARDIZED 
                    DEFINITIONS.

    (a) In General.--Not later than 12 months after the date of 
enactment of the Patient Protection and Affordable Care Act, 
the Secretary shall develop standards for use by a group health 
plan and a health insurance issuer offering group or individual 
health insurance coverage, in compiling and providing to 
applicants, enrollees, and policyholders or certificate holders 
a summary of benefits and coverage explanation that accurately 
describes the benefits and coverage under the applicable plan 
or coverage. In developing such standards, the Secretary shall 
consult with the National Association of Insurance 
Commissioners (referred to in this section as the ``NAIC''), a 
working group composed of representatives of health insurance-
related consumer advocacy organizations, health insurance 
issuers, health care professionals, patient advocates including 
those representing individuals with limited English 
proficiency, and other qualified individuals.
    (b) Requirements.--The standards for the summary of 
benefits and coverage developed under subsection (a) shall 
provide for the following:
            (1) Appearance.--The standards shall ensure that 
        the summary of benefits and coverage is presented in a 
        uniform format that does not exceed 4 pages in length 
        and does not include print smaller than 12-point font.
            (2) Language.--The standards shall ensure that the 
        summary is presented in a culturally and linguistically 
        appropriate manner and utilizes terminology 
        understandable by the average plan enrollee.
            (3) Contents.--The standards shall ensure that the 
        summary of benefits and coverage includes--
                    (A) uniform definitions of standard 
                insurance terms and medical terms (consistent 
                with subsection (g)) so that consumers may 
                compare health insurance coverage and 
                understand the terms of coverage (or exception 
                to such coverage);
                    (B) a description of the coverage, 
                including cost sharing for--
                            (i) each of the categories of the 
                        essential health benefits described in 
                        subparagraphs (A) through (J) of 
                        section 1302(b)(1) of the Patient 
                        Protection and Affordable Care Act; and
                            (ii) other benefits, as identified 
                        by the Secretary;
                    (C) the exceptions, reductions, and 
                limitations on coverage;
                    (D) the cost-sharing provisions, including 
                deductible, coinsurance, and co-payment 
                obligations;
                    (E) the renewability and continuation of 
                coverage provisions;
                    (F) a coverage facts label that includes 
                examples to illustrate common benefits 
                scenarios, including pregnancy and serious or 
                chronic medical conditions and related cost 
                sharing, such scenarios to be based on 
                recognized clinical practice guidelines;
                    (G) a statement of whether the plan or 
                coverage--
                            (i) provides minimum essential 
                        coverage (as defined under section 
                        5000A(f) of the Internal Revenue Code 
                        1986); and
                            (ii) ensures that the plan or 
                        coverage share of the total allowed 
                        costs of benefits provided under the 
                        plan or coverage is not less than 60 
                        percent of such costs;
                    (H) a statement that the outline is a 
                summary of the policy or certificate and that 
                the coverage document itself should be 
                consulted to determine the governing 
                contractual provisions; and
                    (I) a contact number for the consumer to 
                call with additional questions and an Internet 
                web address where a copy of the actual 
                individual coverage policy or group certificate 
                of coverage can be reviewed and obtained.
    (c) Periodic Review and Updating.--The Secretary shall 
periodically review and update, as appropriate, the standards 
developed under this section.
    (d) Requirement To Provide.--
            (1) In general.--Not later than 24 months after the 
        date of enactment of the Patient Protection and 
        Affordable Care Act, each entity described in paragraph 
        (3) shall provide, prior to any enrollment restriction, 
        a summary of benefits and coverage explanation pursuant 
           to the standards developed by the Secretary under 
        subsection (a) to--
                    (A) an applicant at the time of 
                application;
                    (B) an enrollee prior to the time of 
                enrollment or reenrollment, as applicable; and
                    (C) a policyholder or certificate holder at 
                the time of issuance of the policy or delivery 
                of the certificate.
            (2) Compliance.--An entity described in paragraph 
        (3) is deemed to be in compliance with this section if 
        the summary of benefits and coverage described in 
        subsection (a) is provided in paper or electronic form.
            (3) Entities in general.--An entity described in 
        this paragraph is--
                    (A) a health insurance issuer (including a 
                group health plan that is not a self-insured 
                plan) offering health insurance coverage within 
                the United States; or
                    (B) in the case of a self-insured group 
                health plan, the plan sponsor or designated 
                administrator of the plan (as such terms are 
                defined in section 3(16) of the Employee 
                Retirement Income Security Act of 1974).
            (4) Notice of modifications.--If a group health 
        plan or health insurance issuer makes any material 
        modification in any of the terms of the plan or 
        coverage involved (as defined for purposes of section 
        102 of the Employee Retirement Income Security Act of 
        1974) that is not reflected in the most recently 
        provided summary of benefits and coverage, the plan or 
        issuer shall provide notice of such modification to 
        enrollees not later than 60 days prior to the date on 
        which such modification will become effective.
    (e) Preemption.--The standards developed under subsection 
(a) shall preempt any related State standards that require a 
summary of benefits and coverage that provides less information 
to consumers than that required to be provided under this 
section, as determined by the Secretary.
    (f) Failure To Provide.--An entity described in subsection 
(d)(3) that willfully fails to provide the information required 
under this section shall be subject to a fine of not more than 
$1,000 for each such failure. Such failure with respect to each 
enrollee shall constitute a separate offense for purposes of 
this subsection.
    (g) Development of Standard Definitions.--
            (1) In general.--The Secretary shall, by 
        regulation, provide for the development of standards 
        for the definitions of terms used in health insurance 
        coverage, including the insurance-related terms 
        described in paragraph (2) and the medical terms 
        described in paragraph (3).
            (2) Insurance-related terms.--The insurance-related 
        terms described in this paragraph are premium, 
        deductible, co-insurance, co-payment, out-of-pocket 
        limit, preferred provider, non-preferred provider, out-
        of-network co-payments, UCR (usual, customary and 
        reasonable) fees, excluded services, grievance and 
        appeals, and such other terms as the Secretary 
        determines are important to define so that consumers 
        may compare health insurance coverage and understand 
        the terms of their coverage.
            (3) Medical terms.--The medical terms described in 
        this paragraph are hospitalization, hospital outpatient 
        care, emergency room care, physician services, 
        prescription drug coverage, durable medical equipment, 
        home health care, skilled nursing care, rehabilitation 
        services, hospice services, emergency medical 
        transportation, and such other terms as the Secretary 
        determines are important to define so that consumers 
        may compare the medical benefits offered by health 
        insurance and understand the extent of those medical 
        benefits (or exceptions to those benefits).

SEC. 2715A. [300GG-15A] PROVISION OF ADDITIONAL INFORMATION.

    A group health plan and a health insurance issuer offering 
group or individual health insurance coverage shall comply with 
the provisions of section 1311(e)(3) of the Patient Protection 
and Affordable Care Act, except that a plan or coverage that is 
not offered through an Exchange shall only be required to 
submit the information required to the Secretary and the State 
insurance commissioner, and make such information available to 
the public.

SEC. 2716. [300GG-16] PROHIBITION ON DISCRIMINATION IN FAVOR OF HIGHLY 
                    COMPENSATED INDIVIDUALS.

    (a) In General.--A group health plan (other than a self-
insured plan) shall satisfy the requirements of section 
105(h)(2) of the Internal Revenue Code of 1986 (relating to 
prohibition on discrimination in favor of highly compensated 
individuals).
    (b) Rules and Definitions.--For purposes of this section--
            (1) Certain rules to apply.--Rules similar to the 
        rules contained in paragraphs (3), (4), and (8) of 
        section 105(h) of such Code shall apply.
            (2) Highly compensated individual.--The term 
        ``highly compensated individual'' has the meaning given 
        such term by section 105(h)(5) of such Code.

SEC. 2717. [300GG-17] ENSURING THE QUALITY OF CARE.

    (a) Quality Reporting.--
            (1) In general.--Not later than 2 years after the 
        date of enactment of the Patient Protection and 
        Affordable Care Act, the Secretary, in consultation 
        with experts in health care quality and stakeholders, 
        shall develop reporting requirements for use by a group 
        health plan, and a health insurance issuer offering 
        group or individual health insurance coverage, with 
        respect to plan or coverage benefits and health care 
        provider reimbursement structures that--
                    (A) improve health outcomes through the 
                implementation of activities such as quality 
                reporting, effective case management, care 
                coordination, chronic disease management, and 
                medication and care compliance initiatives, 
                including through the use of the medical homes 
                model as defined for purposes of section 3602 
                of the Patient Protection and Affordable Care 
                Act, for treatment or services under the plan 
                or coverage;
                    (B) implement activities to prevent 
                hospital readmissions through a comprehensive 
                program for hospital discharge that includes 
                patient-centered education and counseling, 
                comprehensive discharge planning, and post 
                discharge reinforcement by an appropriate 
                health care professional;
                    (C) implement activities to improve patient 
                safety and reduce medical errors through the 
                appropriate use of best clinical practices, 
                evidence based medicine, and health information 
                technology under the plan or coverage; and
                    (D) implement wellness and health promotion 
                activities.
            (2) Reporting requirements.--
                    (A) In general.--A group health plan and a 
                health insurance issuer offering group or 
                individual health insurance coverage shall 
                annually submit to the Secretary, and to 
                enrollees under the plan or coverage, a report 
                on whether the benefits under the plan or 
                coverage satisfy the elements described in 
                subparagraphs (A) through (D) of paragraph (1).
                    (B) Timing of reports.--A report under 
                subparagraph (A) shall be made available to an 
                enrollee under the plan or coverage during each 
                open enrollment period.
                    (C) Availability of reports.--The Secretary 
                shall make reports submitted under subparagraph 
                (A) available to the public through an Internet 
                website.
                    (D) Penalties.--In developing the reporting 
                requirements under paragraph (1), the Secretary 
                may develop and impose appropriate penalties 
                for non-compliance with such requirements.
                    (E) Exceptions.--In developing the 
                reporting requirements under paragraph (1), the 
                Secretary may provide for exceptions to such 
                requirements for group health plans and health 
                insurance issuers that substantially meet the 
                goals of this section.
    (b) Wellness and Prevention Programs.--For purposes of 
subsection (a)(1)(D), wellness and health promotion activities 
may include personalized wellness and prevention services, 
which are coordinated, maintained or delivered by a health care 
provider, a wellness and prevention plan manager, or a health, 
wellness or prevention services organization that conducts 
health risk assessments or offers ongoing face-to-face, 
telephonic or web-based intervention efforts for each of the 
program's participants, and which may include the following 
wellness and prevention efforts:
            (1) Smoking cessation.
            (2) Weight management.
            (3) Stress management.
            (4) Physical fitness.
            (5) Nutrition.
            (6) Heart disease prevention.
            (7) Healthy lifestyle support.
            (8) Diabetes prevention.
    (c) Protection of Second Amendment Gun Rights.--
            (1) Wellness and prevention programs.--A wellness 
        and health promotion activity implemented under 
        subsection (a)(1)(D) may not require the disclosure or 
        collection of any information relating to--
                    (A) the presence or storage of a lawfully-
                possessed firearm or ammunition in the 
                residence or on the property of an individual; 
                or
                    (B) the lawful use, possession, or storage 
                of a firearm or ammunition by an individual.
            (2) Limitation on data collection.--None of the 
        authorities provided to the Secretary under the Patient 
        Protection and Affordable Care Act or an amendment made 
        by that Act shall be construed to authorize or may be 
        used for the collection of any information relating 
        to--
                    (A) the lawful ownership or possession of a 
                firearm or ammunition;
                    (B) the lawful use of a firearm or 
                ammunition; or
                    (C) the lawful storage of a firearm or 
                ammunition.
            (3) Limitation on databases or data banks.--None of 
        the authorities provided to the Secretary under the 
        Patient Protection and Affordable Care Act or an 
        amendment made by that Act shall be construed to 
        authorize or may be used to maintain records of 
        individual ownership or possession of a firearm or 
        ammunition.
            (4) Limitation on determination of premium rates or 
        eligibility for health insurance.--A premium rate may 
        not be increased, health insurance coverage may not be 
        denied, and a discount, rebate, or reward offered for 
        participation in a wellness program may not be reduced 
        or withheld under any health benefit plan issued 
        pursuant to or in accordance with the Patient 
        Protection and Affordable Care Act or an amendment made 
        by that Act on the basis of, or on reliance upon--
                    (A) the lawful ownership or possession of a 
                firearm or ammunition; or
                    (B) the lawful use or storage of a firearm 
                or ammunition.
            (5) Limitation on data collection requirements for 
        individuals.--No individual shall be required to 
        disclose any information under any data collection 
        activity authorized under the Patient Protection and 
        Affordable Care Act or an amendment made by that Act 
        relating to--
                    (A) the lawful ownership or possession of a 
                firearm or ammunition; or
                    (B) the lawful use, possession, or storage 
                of a firearm or ammunition.
    (d) Regulations.--Not later than 2 years after the date of 
enactment of the Patient Protection and Affordable Care Act, 
the Secretary shall promulgate regulations that provide 
criteria for determining whether a reimbursement structure is 
described in subsection (a).
    (e) Study and Report.--Not later than 180 days after the 
date on which regulations are promulgated under subsection (c), 
the Government Accountability Office shall review such 
regulations and conduct a study and submit to the Committee on 
Health, Education, Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the House of 
Representatives a report regarding the impact the activities 
under this section have had on the quality and cost of health 
care.

SEC. 2718. [300GG-18] BRINGING DOWN THE COST OF HEALTH CARE COVERAGE.

    (a) Clear Accounting for Costs.--A health insurance issuer 
offering group or individual health insurance coverage 
(including a grandfathered health plan) shall, with respect to 
each plan year, submit to the Secretary a report concerning the 
ratio of the incurred loss (or incurred claims) plus the loss 
adjustment expense (or change in contract reserves) to earned 
premiums. Such report shall include the percentage of total 
premium revenue, after accounting for collections or receipts 
for risk adjustment and risk corridors and payments of 
reinsurance, that such coverage expends--
            (1) on reimbursement for clinical services provided 
        to enrollees under such coverage;
            (2) for activities that improve health care 
        quality; and
            (3) on all other non-claims costs, including an 
        explanation of the nature of such costs, and excluding 
        Federal and State taxes and licensing or regulatory 
        fees.
The Secretary shall make reports received under this section 
available to the public on the Internet website of the 
Department of Health and Human Services.
    (b) Ensuring That Consumers Receive Value for Their Premium 
Payments.--
            (1) Requirement to provide value for premium 
        payments.--
                    (A) Requirement.--Beginning not later than 
                January 1, 2011, a health insurance issuer 
                offering group or individual health insurance 
                coverage (including a grandfathered health 
                plan) shall, with respect to each plan year, 
                provide an annual rebate to each enrollee under 
                such coverage, on a pro rata basis, if the 
                ratio of the amount of premium revenue expended 
                by the issuer on costs described in paragraphs 
                (1) and (2) of subsection (a) to the total 
                amount of premium revenue (excluding Federal 
                and State taxes and licensing or regulatory 
                fees and after accounting for payments or 
                receipts for risk adjustment, risk corridors, 
                and reinsurance under sections 1341, 1342, and 
                1343 of the Patient Protection and Affordable 
                Care Act) for the plan year (except as provided 
                in subparagraph (B)(ii)), is less than--
                            (i) with respect to a health 
                        insurance issuer offering coverage in 
                        the large group market, 85 percent, or 
                        such higher percentage as a State may 
                        by regulation determine; or
                            (ii) with respect to a health 
                        insurance issuer offering coverage in 
                        the small group market or in the 
                        individual market, 80 percent, or such 
                        higher percentage as a State may by 
                        regulation determine, except that the 
                        Secretary may adjust such percentage 
                        with respect to a State if the 
                        Secretary determines that the 
                        application of such 80 percent may 
                        destabilize the individual market in 
                        such State.
                    (B) Rebate amount.--
                            (i) Calculation of amount.--The 
                        total amount of an annual rebate 
                        required under this paragraph shall be 
                        in an amount equal to the product of--
                                    (I) the amount by which the 
                                percentage described in clause 
                                (i) or (ii) of subparagraph (A) 
                                exceeds the ratio described in 
                                such subparagraph; and
                                    (II) the total amount of 
                                premium revenue (excluding 
                                Federal and State taxes and 
                                licensing or regulatory fees 
                                and after accounting for 
                                payments or receipts for risk 
                                adjustment, risk corridors, and 
                                reinsurance under sections 
                                1341, 1342, and 1343 of the 
                                Patient Protection and 
                                Affordable Care Act) for such 
                                plan year.
                            (ii) Calculation based on average 
                        ratio.--Beginning on January 1, 2014, 
                        the determination made under 
                        subparagraph (A) for the year involved 
                        shall be based on the averages of the 
                        premiums expended on the costs 
                        described in such subparagraph and 
                        total premium revenue for each of the 
                        previous 3 years for the plan.
            (2) Consideration in setting percentages.--In 
        determining the percentages under paragraph (1), a 
        State shall seek to ensure adequate participation by 
        health insurance issuers, competition in the health 
        insurance market in the State, and value for consumers 
        so that premiums are used for clinical services and 
        quality improvements.
            (3) Enforcement.--The Secretary shall promulgate 
        regulations for enforcing the provisions of this 
        section and may provide for appropriate penalties.
    (c) Definitions.--Not later than December 31, 2010, and 
subject to the certification of the Secretary, the National 
Association of Insurance Commissioners shall establish uniform 
definitions of the activities reported under subsection (a) and 
standardized methodologies for calculating measures of such 
activities, including definitions of which activities, and in 
what regard such activities, constitute activities described in 
subsection (a)(2). Such methodologies shall be designed to take 
into account the special circumstances of smaller plans, 
different types of plans, and newer plans.
    (d) Adjustments.--The Secretary may adjust the rates 
described in subsection (b) if the Secretary determines 
appropriate on account of the volatility of the individual 
market due to the establishment of State Exchanges.
    (e) Standard Hospital Charges.--Each hospital operating 
within the United States shall for each year establish (and 
update) and make public (in accordance with guidelines 
developed by the Secretary) a list of the hospital's standard 
charges for items and services provided by the hospital, 
including for diagnosis-related groups established under 
section 1886(d)(4) of the Social Security Act.

SEC. 2719. [300GG-19] APPEALS PROCESS.

    (a) Internal Claims Appeals.--
            (1) In general.--A group health plan and a health 
        insurance issuer offering group or individual health 
        insurance coverage shall implement an effective appeals 
        process for appeals of coverage determinations and 
        claims, under which the plan or issuer shall, at a 
        minimum--
                    (A) have in effect an internal claims 
                appeal process;
                    (B) provide notice to enrollees, in a 
                culturally and linguistically appropriate 
                manner, of available internal and external 
                appeals processes, and the availability of any 
                applicable office of health insurance consumer 
                assistance or ombudsman established under 
                section 2793 to assist such enrollees with the 
                appeals processes; and
                    (C) allow an enrollee to review their file, 
                to present evidence and testimony as part of 
                the appeals process, and to receive continued 
                coverage pending the outcome of the appeals 
                process.
            (2) Established processes.--To comply with 
        paragraph (1)--
                    (A) a group health plan and a health 
                insurance issuer offering group health coverage 
                shall provide an internal claims and appeals 
                process that initially incorporates the claims 
                and appeals procedures (including urgent 
                claims) set forth at section 2560.503-1 of 
                title 29, Code of Federal Regulations, as 
                published on November 21, 2000 (65 Fed. Reg. 
                70256), and shall update such process in 
                accordance with any standards established by 
                the Secretary of Labor for such plans and 
                issuers; and
                    (B) a health insurance issuer offering 
                individual health coverage, and any other 
                issuer not subject to subparagraph (A), shall 
                provide an internal claims and appeals process 
                that initially incorporates the claims and 
                appeals procedures set forth under applicable 
                law (as in existence on the date of enactment 
                of this section), and shall update such process 
                in accordance with any standards established by 
                the Secretary of Health and Human Services for 
                such issuers.
    (b) External Review.--A group health plan and a health 
insurance issuer offering group or individual health insurance 
coverage--
            (1) shall comply with the applicable State external 
        review process for such plans and issuers that, at a 
        minimum, includes the consumer protections set forth in 
        the Uniform External Review Model Act promulgated by 
        the National Association of Insurance Commissioners and 
        is binding on such plans; or
            (2) shall implement an effective external review 
        process that meets minimum standards established by the 
        Secretary through guidance and that is similar to the 
        process described under paragraph (1)--
                    (A) if the applicable State has not 
                established an external review process that 
                meets the requirements of paragraph (1); or
                    (B) if the plan is a self-insured plan that 
                is not subject to State insurance regulation 
                (including a State law that establishes an 
                external review process described in paragraph 
                (1)).
    (c) Secretary Authority.--The Secretary may deem the 
external review process of a group health plan or health 
insurance issuer, in operation as of the date of enactment of 
this section, to be in compliance with the applicable process 
established under subsection (b), as determined appropriate by 
the Secretary.

SEC. 2719A. [300GG-19A] PATIENT PROTECTIONS.

    (a) Choice of Health Care Professional.--If a group health 
plan, or a health insurance issuer offering group or individual 
health insurance coverage, requires or provides for designation 
by a participant, beneficiary, or enrollee of a participating 
primary care provider, then the plan or issuer shall permit 
each participant, beneficiary, and enrollee to designate any 
participating primary care provider who is available to accept 
such individual.
    (b) Coverage of Emergency Services.--
            (1) In general.--If a group health plan, or a 
        health insurance issuer offering group or individual 
        health insurance issuer, provides or covers any 
        benefits with respect to services in an emergency 
        department of a hospital, the plan or issuer shall 
        cover emergency services (as defined in paragraph 
        (2)(B))--
                    (A) without the need for any prior 
                authorization determination;
                    (B) whether the health care provider 
                furnishing such services is a participating 
                provider with respect to such services;
                    (C) in a manner so that, if such services 
                are provided to a participant, beneficiary, or 
                enrollee--
                            (i) by a nonparticipating health 
                        care provider with or without prior 
                        authorization; or
                            (ii)(I) such services will be 
                        provided without imposing any 
                        requirement under the plan for prior 
                        authorization of services or any 
                        limitation on coverage where the 
                        provider of services does not have a 
                        contractual relationship with the plan 
                        for the providing of services that is 
                        more restrictive than the requirements 
                        or limitations that apply to emergency 
                        department services received from 
                        providers who do have such a 
                        contractual relationship with the plan; 
                        and
                            (II) if such services are provided 
                        out-of-network, the cost-sharing 
                        requirement (expressed as a copayment 
                        amount or coinsurance rate) is the same 
                        requirement that would apply if such 
                        services were provided in-network; \1\
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    \1\ Probably should read ``; and''.
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                    (D) without regard to any other term or 
                condition of such coverage (other than 
                exclusion or coordination of benefits, or an 
                affiliation or waiting period, permitted under 
                section 2701 of this Act, section 701 of the 
                Employee Retirement Income Security Act of 
                1974, or section 9801 of the Internal Revenue 
                Code of 1986, and other than applicable cost-
                sharing).
            (2) Definitions.--In this subsection:
                    (A) Emergency medical condition.--The term 
                ``emergency medical condition'' means a medical 
                condition manifesting itself by acute symptoms 
                of sufficient severity (including severe pain) 
                such that a prudent layperson, who possesses an 
                average knowledge of health and medicine, could 
                reasonably expect the absence of immediate 
                medical attention to result in a condition 
                described in clause (i), (ii), or (iii) of 
                section 1867(e)(1)(A) of the Social Security 
                Act.
                    (B) Emergency services.--The term 
                ``emergency services'' means, with respect to 
                an emergency medical condition--
                            (i) a medical screening examination 
                        (as required under section 1867 of the 
                        Social Security Act) that is within the 
                        capability of the emergency department 
                        of a hospital, including ancillary 
                        services routinely available to the 
                        emergency department to evaluate such 
                        emergency medical condition, and
                            (ii) within the capabilities of the 
                        staff and facilities available at the 
                        hospital, such further medical 
                        examination and treatment as are 
                        required under section 1867 of such Act 
                        to stabilize the patient.
                    (C) Stabilize.--The term ``to stabilize'', 
                with respect to an emergency medical condition 
                (as defined in subparagraph (A)), has the 
                meaning give in section 1867(e)(3) of the 
                Social Security Act (42 U.S.C. 1395dd(e)(3)).
    (c) Access to Pediatric Care.--
            (1) Pediatric care.--In the case of a person who 
        has a child who is a participant, beneficiary, or 
        enrollee under a group health plan, or health insurance 
        coverage offered by a health insurance issuer in the 
        group or individual market, if the plan or issuer 
        requires or provides for the designation of a 
        participating primary care provider for the child, the 
        plan or issuer shall permit such person to designate a 
        physician (allopathic or osteopathic) who specializes 
        in pediatrics as the child's primary care provider if 
        such provider participates in the network of the plan 
        or issuer.
            (2) Construction.--Nothing in paragraph (1) shall 
        be construed to waive any exclusions of coverage under 
        the terms and conditions of the plan or health 
        insurance coverage with respect to coverage of 
        pediatric care.
    (d) Patient Access to Obstetrical and Gynecological Care.--
            (1) General rights.--
                    (A) Direct access.--A group health plan, or 
                health insurance issuer offering group or 
                individual health insurance coverage, described 
                in paragraph (2) may not require authorization 
                or referral by the plan, issuer, or any person 
                (including a primary care provider described in 
                paragraph (2)(B)) in the case of a female 
                participant, beneficiary, or enrollee who seeks 
                coverage for obstetrical or gynecological care 
                provided by a participating health care 
                professional who specializes in obstetrics or 
                gynecology. Such professional shall agree to 
                otherwise adhere to such plan's or issuer's 
                policies and procedures, including procedures 
                regarding referrals and obtaining prior 
                authorization and providing services pursuant 
                to a treatment plan (if any) approved by the 
                plan or issuer.
                    (B) Obstetrical and gynecological care.--A 
                group health plan or health insurance issuer 
                described in paragraph (2) shall treat the 
                provision of obstetrical and gynecological 
                care, and the ordering of related obstetrical 
                and gynecological items and services, pursuant 
                to the direct access described under 
                subparagraph (A), by a participating health 
                care professional who specializes in obstetrics 
                or gynecology as the authorization of the 
                primary care provider.
            (2) Application of paragraph.--A group health plan, 
        or health insurance issuer offering group or individual 
        health insurance coverage, described in this paragraph 
        is a group health plan or coverage that--
                    (A) provides coverage for obstetric or 
                gynecologic care; and
                    (B) requires the designation by a 
                participant, beneficiary, or enrollee of a 
                participating primary care provider.
            (3) Construction.--Nothing in paragraph (1) shall 
        be construed to--
                    (A) waive any exclusions of coverage under 
                the terms and conditions of the plan or health 
                insurance coverage with respect to coverage of 
                obstetrical or gynecological care; or
                    (B) preclude the group health plan or 
                health insurance issuer involved from requiring 
                that the obstetrical or gynecological provider 
                notify the primary care health care 
                professional or the plan or issuer of treatment 
                decisions.

SEC. 2725. \1\ [300GG-25] STANDARDS RELATING TO BENEFITS FOR MOTHERS 
                    AND NEWBORNS.
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    \1\ The placement of this section and succeeding sections 2726, 
2727, and 2728 here, versus after section 2724, is ambiguous insofar as 
these sections at the time of their redesignation from sections 2702-
2708 were not explicitly moved to follow section 2724, yet the failure 
to place them after section 2724 results in these sections not 
following ordinary sequential numbering.
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    (a) Requirements for Minimum Hospital Stay Following 
Birth.--
            (1) In general.--A group health plan, and a health 
        insurance issuer offering group or individual health 
        insurance coverage, may not--
                    (A) except as provided in paragraph (2)--
                            (i) restrict benefits for any 
                        hospital length of stay in connection 
                        with childbirth for the mother or 
                        newborn child, following a normal 
                        vaginal delivery, to less than 48 
                        hours, or
                            (ii) restrict benefits for any 
                        hospital length of stay in connection 
                        with childbirth for the mother or 
                        newborn child, following a cesarean 
                        section, to less than 96 hours, or
                    (B) require that a provider obtain 
                authorization from the plan or the issuer for 
                prescribing any length of stay required under 
                subparagraph (A) (without regard to paragraph 
                (2)).
            (2) Exception.--Paragraph (1)(A) shall not apply in 
        connection with any group health plan or health 
        insurance issuer in any case in which the decision to 
        discharge the mother or her newborn child prior to the 
        expiration of the minimum length of stay otherwise 
        required under paragraph (1)(A) is made by an attending 
        provider in consultation with the mother.
    (b) Prohibitions.--A group health plan, and a health 
insurance issuer offering group or individual health insurance 
coverage, may not--
            (1) deny to the mother or her newborn child 
        eligibility, or continued eligibility, to enroll or to 
        renew coverage under the terms of the plan or coverage, 
        solely for the purpose of avoiding the requirements of 
        this section;
            (2) provide monetary payments or rebates to mothers 
        to encourage such mothers to accept less than the 
        minimum protections available under this section;
            (3) penalize or otherwise reduce or limit the 
        reimbursement of an attending provider because such 
        provider provided care to an individual participant or 
        beneficiary in accordance with this section;
            (4) provide incentives (monetary or otherwise) to 
        an attending provider to induce such provider to 
        provide care to an individual participant or 
        beneficiary in a manner inconsistent with this section; 
        or
            (5) subject to subsection (c)(3), restrict benefits 
        for any portion of a period within a hospital length of 
        stay required under subsection (a) in a manner which is 
        less favorable than the benefits provided for any 
        preceding portion of such stay.
    (c) Rules of Construction.--
            (1) Nothing in this section shall be construed to 
        require a mother who is a participant or beneficiary--
                    (A) to give birth in a hospital; or
                    (B) to stay in the hospital for a fixed 
                period of time following the birth of her 
                child.
            (2) This section shall not apply with respect to 
        any group health plan, or any health insurance issuer 
        offering group or individual health insurance coverage, 
        which does not provide benefits for hospital lengths of 
        stay in connection with childbirth for a mother or her 
        newborn child.
            (3) Nothing in this section shall be construed as 
        preventing a group health plan or health insurance 
        issuer from imposing deductibles, coinsurance, or other 
        cost-sharing in relation to benefits for hospital 
        lengths of stay in connection with childbirth for a 
        mother or newborn child under the plan (or under health 
        insurance coverage offered in connection with a group 
        health plan), except that such coinsurance or other 
        cost-sharing for any portion of a period within a 
        hospital length of stay required under subsection (a) 
        may not be greater than such coinsurance or cost-
        sharing for any preceding portion of such stay.
    (d) Notice.--A group health plan under this part shall 
comply with the notice requirement under section 711(d) of the 
Employee Retirement Income Security Act of 1974 with respect to 
the requirements of this section as if such section applied to 
such plan.
    (e) Level and Type of Reimbursements.--Nothing in this 
section shall be construed to prevent a group health plan or a 
health insurance issuer offering group or individual health 
insurance coverage from negotiating the level and type of 
reimbursement with a provider for care provided in accordance 
with this section.
    (f) Preemption; Exception for Health Insurance Coverage in 
Certain States.--
            (1) In general.--The requirements of this section 
        shall not apply with respect to health insurance 
        coverage if there is a State law (as defined in section 
        2723(d)(1)) for a State that regulates such coverage 
        that is described in any of the following 
        subparagraphs:
                    (A) Such State law requires such coverage 
                to provide for at least a 48-hour hospital 
                length of stay following a normal vaginal 
                delivery and at least a 96-hour hospital length 
                of stay following a cesarean section.
                    (B) Such State law requires such coverage 
                to provide for maternity and pediatric care in 
                accordance with guidelines established by the 
                American College of Obstetricians and 
                Gynecologists, the American Academy of 
                Pediatrics, or other established professional 
                medical associations.
                    (C) Such State law requires, in connection 
                with such coverage for maternity care, that the 
                hospital length of stay for such care is left 
                to the decision of (or required to be made by) 
                the attending provider in consultation with the 
                mother.
            (2) Construction.--Section 2723(a)(1) shall not be 
        construed as superseding a State law described in 
        paragraph (1).

SEC. 2726. [300GG-26] PARITY IN MENTAL HEALTH AND SUBSTANCE USE 
                    DISORDER BENEFITS.

    (a) In General.--
            (1) Aggregate lifetime limits.--In the case of a 
        group health plan or a health insurance issuer offering 
        group or individual health insurance coverage that 
        provides both medical and surgical benefits and mental 
        health or substance use disorder benefits--
                    (A) No lifetime limit.--If the plan or 
                coverage does not include an aggregate lifetime 
                limit on substantially all medical and surgical 
                benefits, the plan or coverage may not impose 
                any aggregate lifetime limit on mental health 
                or substance use disorder benefits.
                    (B) Lifetime limit.--If the plan or 
                coverage includes an aggregate lifetime limit 
                on substantially all medical and surgical 
                benefits (in this paragraph referred to as the 
                ``applicable lifetime limit''), the plan or 
                coverage shall either--
                            (i) apply the applicable lifetime 
                        limit both to the medical and surgical 
                        benefits to which it otherwise would 
                        apply and to mental health and 
                        substance use disorder benefits and not 
                        distinguish in the application of such 
                        limit between such medical and surgical 
                        benefits and mental health and 
                        substance use disorder benefits; or
                            (ii) not include any aggregate 
                        lifetime limit on mental health or 
                        substance use disorder benefits that is 
                        less than the applicable lifetime 
                        limit.
                    (C) Rule in case of different limits.--In 
                the case of a plan or coverage that is not 
                described in subparagraph (A) or (B) and that 
                includes no or different aggregate lifetime 
                limits on different categories of medical and 
                surgical benefits, the Secretary shall 
                establish rules under which subparagraph (B) is 
                applied to such plan or coverage with respect 
                to mental health and substance use disorder 
                benefits by substituting for the applicable 
                lifetime limit an average aggregate lifetime 
                limit that is computed taking into account the 
                weighted average of the aggregate lifetime 
                limits applicable to such categories.
            (2) Annual limits.--In the case of a group health 
        plan or a health insurance issuer offering group or 
        individual health insurance coverage that provides both 
        medical and surgical benefits and mental health or 
        substance use disorder benefits--
                    (A) No annual limit.--If the plan or 
                coverage does not include an annual limit on 
                substantially all medical and surgical 
                benefits, the plan or coverage may not impose 
                any annual limit on mental health or substance 
                use disorder benefits.
                    (B) Annual limit.--If the plan or coverage 
                includes an annual limit on substantially all 
                medical and surgical benefits (in this 
                paragraph referred to as the ``applicable 
                annual limit''), the plan or coverage shall 
                either--
                            (i) apply the applicable annual 
                        limit both to medical and surgical 
                        benefits to which it otherwise would 
                        apply and to mental health and 
                        substance use disorder benefits and not 
                        distinguish in the application of such 
                        limit between such medical and surgical 
                        benefits and mental health and 
                        substance use disorder benefits; or
                            (ii) not include any annual limit 
                        on mental health or substance use 
                        disorder benefits that is less than the 
                        applicable annual limit.
                    (C) Rule in case of different limits.--In 
                the case of a plan or coverage that is not 
                described in subparagraph (A) or (B) and that 
                includes no or different annual limits on 
                different categories of medical and surgical 
                benefits, the Secretary shall establish rules 
                under which subparagraph (B) is applied to such 
                plan or coverage with respect to mental health 
                and substance use disorder benefits by 
                substituting for the applicable annual limit an 
                average annual limit that is computed taking 
                into account the weighted average of the annual 
                limits applicable to such categories.
            (3) Financial requirements and treatment 
        limitations.--
                    (A) In general.--In the case of a group 
                health plan or a health insurance issuer 
                offering group or individual health insurance 
                coverage that provides both medical and 
                surgical benefits and mental health or 
                substance use disorder benefits, such plan or 
                coverage shall ensure that--
                            (i) the financial requirements 
                        applicable to such mental health or 
                        substance use disorder benefits are no 
                        more restrictive than the predominant 
                        financial requirements applied to 
                        substantially all medical and surgical 
                        benefits covered by the plan (or 
                        coverage), and there are no separate 
                        cost sharing requirements that are 
                        applicable only with respect to mental 
                        health or substance use disorder 
                        benefits; and
                            (ii) the treatment limitations 
                        applicable to such mental health or 
                        substance use disorder benefits are no 
                        more restrictive than the predominant 
                        treatment limitations applied to 
                        substantially all medical and surgical 
                        benefits covered by the plan (or 
                        coverage) and there are no separate 
                        treatment limitations that are 
                        applicable only with respect to mental 
                        health or substance use disorder 
                        benefits.
                    (B) Definitions.--In this paragraph:
                            (i) Financial requirement.--The 
                        term ``financial requirement'' includes 
                        deductibles, copayments, coinsurance, 
                        and out-of-pocket expenses, but 
                        excludes an aggregate lifetime limit 
                        and an annual limit subject to 
                        paragraphs (1) and (2).
                            (ii) Predominant.--A financial 
                        requirement or treatment limit is 
                        considered to be predominant if it is 
                        the most common or frequent of such 
                        type of limit or requirement.
                            (iii) Treatment limitation.--The 
                        term ``treatment limitation'' includes 
                        limits on the frequency of treatment, 
                        number of visits, days of coverage, or 
                        other similar limits on the scope or 
                        duration of treatment.
            (4) Availability of plan information.--The criteria 
        for medical necessity determinations made under the 
        plan with respect to mental health or substance use 
        disorder benefits (or the health insurance coverage 
        offered in connection with the plan with respect to 
        such benefits) shall be made available by the plan 
        administrator (or the health insurance issuer offering 
        such coverage) in accordance with regulations to any 
        current or potential participant, beneficiary, or 
        contracting provider upon request. The reason for any 
        denial under the plan (or coverage) of reimbursement or 
        payment for services with respect to mental health or 
        substance use disorder benefits in the case of any 
        participant or beneficiary shall, on request or as 
        otherwise required, be made available by the plan 
        administrator (or the health insurance issuer offering 
        such coverage) to the participant or beneficiary in 
        accordance with regulations.
            (5) Out-of-network providers.--In the case of a 
        plan or coverage that provides both medical and 
        surgical benefits and mental health or substance use 
        disorder benefits, if the plan or coverage provides 
        coverage for medical or surgical benefits provided by 
        out-of-network providers, the plan or coverage shall 
        provide coverage for mental health or substance use 
        disorder benefits provided by out-of-network providers 
        in a manner that is consistent with the requirements of 
        this section.
    (b) Construction.--Nothing in this section shall be 
construed--
            (1) as requiring a group health plan or a health 
        insurance issuer offering group or individual health 
        insurance coverage to provide any mental health or 
        substance use disorder benefits; or
            (2) in the case of a group health plan or a health 
        insurance issuer offering group or individual health 
        insurance coverage that provides mental health or 
        substance use disorder benefits, as affecting the terms 
        and conditions of the plan or coverage relating to such 
        benefits under the plan or coverage, except as provided 
        in subsection (a).
    (c) Exemptions.--
            (1) Small employer exemption.--This section shall 
        not apply to any group health plan and a health 
        insurance issuer offering group or individual health 
        insurance coverage for any plan year of a small 
        employer (as defined in section 2791(e)(4), except that 
        for purposes of this paragraph such term shall include 
        employers with 1 employee in the case of an employer 
        residing in a State that permits small groups to 
        include a single individual).
            (2) Cost exemption.--
                    (A) In general.--With respect to a group 
                health plan or a health insurance issuer 
                offering group or individual health insurance 
                coverage, if the application of this section to 
                such plan (or coverage) results in an increase 
                for the plan year involved of the actual total 
                costs of coverage with respect to medical and 
                surgical benefits and mental health and 
                substance use disorder benefits under the plan 
                (as determined and certified under subparagraph 
                (C)) by an amount that exceeds the applicable 
                percentage described in subparagraph (B) of the 
                actual total plan costs, the provisions of this 
                section shall not apply to such plan (or 
                coverage) during the following plan year, and 
                such exemption shall apply to the plan (or 
                coverage) for 1 plan year. An employer may 
                elect to continue to apply mental health and 
                substance use disorder parity pursuant to this 
                section with respect to the group health plan 
                (or coverage) involved regardless of any 
                increase in total costs.
                    (B) Applicable percentage.--With respect to 
                a plan (or coverage), the applicable percentage 
                described in this subparagraph shall be--
                            (i) 2 percent in the case of the 
                        first plan year in which this section 
                        is applied; and
                            (ii) 1 percent in the case of each 
                        subsequent plan year.
                    (C) Determinations by actuaries.--
                Determinations as to increases in actual costs 
                under a plan (or coverage) for purposes of this 
                section shall be made and certified by a 
                qualified and licensed actuary who is a member 
                in good standing of the American Academy of 
                Actuaries. All such determinations shall be in 
                a written report prepared by the actuary. The 
                report, and all underlying documentation relied 
                upon by the actuary, shall be maintained by the 
                group health plan or health insurance issuer 
                for a period of 6 years following the 
                notification made under subparagraph (E).
                    (D) 6-month determinations.--If a group 
                health plan (or a health insurance issuer 
                offering coverage in connection with a group 
                health plan) \1\ seeks an exemption under this 
                paragraph, determinations under subparagraph 
                (A) shall be made after such plan (or coverage) 
                has complied with this section for the first 6 
                months of the plan year involved.
---------------------------------------------------------------------------
    \1\ In section 1563 (relating to conforming amendments--originally 
designated as section 1562 and redesignated as section 1563 by section 
10107(b)(1)) of Public Law 111-148, Congress may have intended to 
replace the parenthetical with a reference to both group and individual 
health insurance. The Congression intent is unclear.
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                    (E) Notification.--
                            (i) In general.--A group health 
                        plan (or a health insurance issuer 
                        offering coverage in connection with a 
                        group health plan) \1\ that, based upon 
                        a certification described under 
                        subparagraph (C), qualifies for an 
                        exemption under this paragraph, and 
                        elects to implement the exemption, 
                        shall promptly notify the Secretary, 
                        the appropriate State agencies, and 
                        participants and beneficiaries in the 
                        plan of such election.
                            (ii) Requirement.--A notification 
                        to the Secretary under clause (i) shall 
                        include--
                                    (I) a description of the 
                                number of covered lives under 
                                the plan (or coverage) involved 
                                at the time of the 
                                notification, and as 
                                applicable, at the time of any 
                                prior election of the cost-
                                exemption under this paragraph 
                                by such plan (or coverage);
                                    (II) for both the plan year 
                                upon which a cost exemption is 
                                sought and the year prior, a 
                                description of the actual total 
                                costs of coverage with respect 
                                to medical and surgical 
                                benefits and mental health and 
                                substance use disorder benefits 
                                under the plan; and
                                    (III) for both the plan 
                                year upon which a cost 
                                exemption is sought and the 
                                year prior, the actual total 
                                costs of coverage with respect 
                                to mental health and substance 
                                use disorder benefits under the 
                                plan.
                            (iii) Confidentiality.--A 
                        notification to the Secretary under 
                        clause (i) shall be confidential. The 
                        Secretary shall make available, upon 
                        request and on not more than an annual 
                        basis, an anonymous itemization of such 
                        notifications, that includes--
                                    (I) a breakdown of States 
                                by the size and type of 
                                employers submitting such 
                                notification; and
                                    (II) a summary of the data 
                                received under clause (ii).
                    (F) Audits by appropriate agencies.--To 
                determine compliance with this paragraph, the 
                Secretary may audit the books and records of a 
                group health plan or health insurance issuer 
                relating to an exemption, including any 
                actuarial reports prepared pursuant to 
                subparagraph (C), during the 6 year period 
                following the notification of such exemption 
                under subparagraph (E). A State agency 
                receiving a notification under subparagraph (E) 
                may also conduct such an audit with respect to 
                an exemption covered by such notification.
    (d) Separate Application to Each Option Offered.--In the 
case of a group health plan that offers a participant or 
beneficiary two or more benefit package options under the plan, 
the requirements of this section shall be applied separately 
with respect to each such option.
    (e) Definitions.--For purposes of this section--
            (1) Aggregate lifetime limit.--The term ``aggregate 
        lifetime limit'' means, with respect to benefits under 
        a group health plan or health insurance coverage, a 
        dollar limitation on the total amount that may be paid 
        with respect to such benefits under the plan or health 
        insurance coverage with respect to an individual or 
        other coverage unit.
            (2) Annual limit.--The term ``annual limit'' means, 
        with respect to benefits under a group health plan or 
        health 
        insurance coverage, a dollar limitation on the total 
        amount of benefits that may be paid with respect to 
        such benefits in a 12-month period under the plan or 
        health insurance coverage with respect to an individual 
        or other coverage unit.
            (3) Medical or surgical benefits.--The term 
        ``medical or surgical benefits'' means benefits with 
        respect to 
        medical or surgical services, as defined under the 
        terms of the plan or coverage (as the case may be), but 
        does not include mental health or substance use 
        disorder benefits.
            (4) Mental health benefits.--The term ``mental 
        health benefits'' means benefits with respect to 
        services for mental health conditions, as defined under 
        the terms of the plan and in accordance with applicable 
        Federal and State law.
            (5) Substance use disorder benefits.--The term 
        ``substance use disorder benefits'' means benefits with 
        respect to services for substance use disorders, as 
        defined under the terms of the plan and in accordance 
        with applicable Federal and State law.

SEC. 2727. [300GG-27] REQUIRED COVERAGE FOR RECONSTRUCTIVE SURGERY 
                    FOLLOWING MASTECTOMIES. \1\

    The provisions of section 713 of the Employee Retirement 
Income Security Act of 1974 shall apply to group health plans, 
and and \2\ health insurance issuers offering group or 
individual health insurance coverage, as if included in this 
subpart.
---------------------------------------------------------------------------
    \1\ Section 2706 (prior to its redesignation as 2727 by Public Law 
111-148) was added by subsection (a) of section 903 of the Departments 
of Labor, Health and Human Services, and Education, and Related 
Agencies Appropriations Act, 1999 (as contained in section 101(f) of 
division A of Public Law 105-277; 112 Stat. 2681-438). Subsection (c) 
of such section 903 concerns effective dates, and paragraph (1) of the 
subsection provides as follows:
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          ``(1) Group plans.--

                  ``(A) In general.--The amendment made by subsection 
                (a) shall apply to group health plans for plan years 
                beginning on or after the date of enactment of this 
                Act.
                  ``(B) Special rule for collective bargaining 
                agreements.--In the case of a group health plan 
                maintained pursuant to 1 or more collective bargaining 
                agreements between employee representatives and 1 or 
                more employers, any plan amendment made pursuant to a 
                collective bargaining agreement relating to the plan 
                which amends the plan solely to conform to any 
                requirement added by the amendment made by subsection 
                (a) shall not be treated as a termination of such 
                collective bargaining agreement.''.
---------------------------------------------------------------------------
    The Public Law was enacted October 21, 1998.
    \2\ So in law.
---------------------------------------------------------------------------

SEC. 2728. [300GG-28] COVERAGE OF DEPENDENT STUDENTS ON MEDICALLY 
                    NECESSARY LEAVE OF ABSENCE.

    (a) Medically Necessary Leave of Absence.--In this section, 
the term ``medically necessary leave of absence'' means, with 
respect to a dependent child described in subsection (b)(2) in 
connection with a group health plan or individual health 
insurance coverage, a leave of absence of such child from a 
postsecondary educational institution (including an institution 
of higher education as defined in section 102 of the Higher 
Education Act of 1965), or any other change in enrollment of 
such child at such an institution, that--
            (1) commences while such child is suffering from a 
        serious illness or injury;
            (2) is medically necessary; and
            (3) causes such child to lose student status for 
        purposes of coverage under the terms of the plan or 
        coverage.
    (b) Requirement To Continue Coverage.--
            (1) In general.--In the case of a dependent child 
        described in paragraph (2), a group health plan, or a 
        health insurance issuer that offers group or individual 
        health insurance coverage, shall not terminate coverage 
        of such child under such plan or health insurance 
        coverage due to a medically necessary leave of absence 
        before the date that is the earlier of--
                    (A) the date that is 1 year after the first 
                day of the medically necessary leave of 
                absence; or
                    (B) the date on which such coverage would 
                otherwise terminate under the terms of the plan 
                or health insurance coverage.
            (2) Dependent child described.--A dependent child 
        described in this paragraph is, with respect to a group 
        health plan or individual health insurance coverage, a 
        beneficiary under the plan who--
                    (A) is a dependent child, under the terms 
                of the plan or coverage, of a participant or 
                beneficiary under the plan or coverage; and
                    (B) was enrolled in the plan or coverage, 
                on the basis of being a student at a 
                postsecondary educational institution (as 
                described in subsection (a)), immediately 
                before the first day of the medically necessary 
                leave of absence involved.
            (3) Certification by physician.--Paragraph (1) 
        shall apply to a group health plan or individual health 
        insurance coverage only if the plan or issuer of the 
        coverage has received written certification by a 
        treating physician of the dependent child which states 
        that the child is suffering from a serious illness or 
        injury and that the leave of absence (or other change 
        of enrollment) described in subsection (a) is medically 
        necessary.
    (c) Notice.--A group health plan, and a health insurance 
issuer that offers group or individual health insurance 
coverage, shall include, with any notice regarding a 
requirement for certification of student status for coverage 
under the plan or coverage, a description of the terms of this 
section for continued coverage during medically necessary 
leaves of absence. Such description shall be in language which 
is understandable to the typical plan participant.
    (d) No Change in Benefits.--A dependent child whose 
benefits are continued under this section shall be entitled to 
the same benefits as if (during the medically necessary leave 
of absence) the child continued to be a covered student at the 
institution of higher education and was not on a medically 
necessary leave of absence.
    (e) Continued Application in Case of Changed Coverage.--
If--
            (1) a dependent child of a participant or 
        beneficiary is in a period of coverage under a group 
        health plan or individual health insurance coverage, 
        pursuant to a medically necessary leave of absence of 
        the child described in subsection (b);
            (2) the manner in which the participant or 
        beneficiary is covered under the plan changes, whether 
        through a change in health insurance coverage or health 
        insurance issuer, a change between health insurance 
        coverage and self-insured coverage, or otherwise; and
            (3) the coverage as so changed continues to provide 
        coverage of beneficiaries as dependent children,
this section shall apply to coverage of the child under the 
changed coverage for the remainder of the period of the 
medically necessary leave of absence of the dependent child 
under the plan in the same manner as it would have applied if 
the changed coverage had been the previous coverage.

         Subpart 2--Exclusion of Plans; Enforcement; Preemption

SEC. 2722. \1\ [300GG-21] EXCLUSION OF CERTAIN PLANS.
---------------------------------------------------------------------------

    \1\ The numerical sequence of section enumerators beginning in 
subpart 2 so in law. See section enumerators at the end of subpart 1 of 
this part and amendments redesignating section enumerators in subpart 2 
by section 1001(4) and section 1563(c)(12) of Public Law 111-148. See 
footnote accompanying section 2725 regarding ambiguity in placement of 
sections 2725-2728.

     There are conflicting amendments made to provisions of this 
section by section 1563(a) and section 1563(c)(12)(B) (relating to 
conforming amendments--originally designated as section 1562 and 
redesignated as section 1563 by section 10107(b)(1)) of Public Law 111-
148. The amendments reflected here are from section 1563(a) of such 
Public Law and thereby render the global amendment made by subsection 
(c)(12)(B) unexecutable.
---------------------------------------------------------------------------
    (a) Limitation on Application of Provisions Relating to 
Group Health Plans.--
            (1) In general.--The requirements of subparts 1 and 
        2 \2\ shall apply with respect to group health plans 
        only--
---------------------------------------------------------------------------
    \2\ The references to ``subparts 1 and 2'' probably should read 
``subparts I and II''.
---------------------------------------------------------------------------
                    (A) subject to paragraph (2), in the case 
                of a plan that is a nonfederal governmental 
                plan, and
                    (B) with respect to health insurance 
                coverage offered in connection with a group 
                health plan (including such a plan that is a 
                church plan or a governmental plan).
            (2) Treatment of nonfederal governmental plans.--
                    (A) Election to be excluded.--Except as 
                provided in subparagraph (D) or (E), if the 
                plan sponsor of a nonfederal governmental plan 
                which is a group health plan to which the 
                provisions of subparts 1 and 2 \3\ otherwise 
                apply makes an election under this subparagraph 
                (in such form and manner as the Secretary may 
                by regulations prescribe), then the 
                requirements of such subparts insofar as they 
                apply directly to group health plans (and not 
                merely to group health insurance coverage) 
                shall not apply to such governmental plans for 
                such period except as provided in this 
                paragraph.
                    (B) Period of election.--An election under 
                subparagraph (A) shall apply--
                            (i) for a single specified plan 
                        year, or
                            (ii) in the case of a plan provided 
                        pursuant to a collective bargaining 
                        agreement, for the term of such 
                        agreement.
                An election under clause (i) may be extended 
                through subsequent elections under this 
                paragraph.
                    (C) Notice to enrollees.--Under such an 
                election, the plan shall provide for--
                            (i) notice to enrollees (on an 
                        annual basis and at the time of 
                        enrollment under the plan) of the fact 
                        and consequences of such election, and
                            (ii) certification and disclosure 
                        of creditable coverage under the plan 
                        with respect to enrollees in accordance 
                        with section 2701(e).
                    (D) Election not applicable to requirements 
                concerning genetic information.--The election 
                described in subparagraph (A) shall not be 
                available with respect to the provisions of 
                subsections (a)(1)(F), (b)(3), (c), and (d) of 
                section 2702 and the provisions of sections 
                2701 and 2702(b) to the extent that such 
                provisions apply to genetic information.
                    (E) Election not applicable.--The election 
                described in subparagraph (A) shall not be 
                available with respect to the provisions of 
                subparts I and II.
    (b) Exception for Certain Benefits.--The requirements of 
subparts 1 and 2 \1\ shall not apply to any individual coverage 
or any group health plan (or group health insurance coverage) 
in relation to its provision of excepted benefits described in 
section 2791(c)(1).
---------------------------------------------------------------------------
    \1\ The references to ``subparts 1 and 2'' probably should read 
``subparts I and II''.
---------------------------------------------------------------------------
    (c) Exception for Certain Benefits If Certain Conditions 
Met.--
            (1) Limited, excepted benefits.--The requirements 
        of subparts 1 and 2 \1\ shall not apply to any 
        individual coverage or any group health plan (and group 
        health insurance coverage offered in connection with a 
        group health plan) in relation to its provision of 
        excepted benefits described in section 2791(c)(2) if 
        the benefits--
                    (A) are provided under a separate policy, 
                certificate, or contract of insurance; or
                    (B) are otherwise not an integral part of 
                the plan.
            (2) Noncoordinated, excepted benefits.--The 
        requirements of subparts 1 and 2 \1\ shall not apply to 
        any individual coverage or any group health plan (and 
        group health insurance coverage offered in connection 
        with a group health plan) in relation to its provision 
        of excepted benefits described in section 2791(c)(3) if 
        all of the following conditions are met:
                    (A) The benefits are provided under a 
                separate policy, certificate, or contract of 
                insurance.
                    (B) There is no coordination between the 
                provision of such benefits and any exclusion of 
                benefits under any group health plan maintained 
                by the same plan sponsor.
                    (C) Such benefits are paid with respect to 
                an event without regard to whether benefits are 
                provided with respect to such an event under 
                any group health plan maintained by the same 
                plan sponsor or, with respect to individual 
                coverage, under any health insurance coverage 
                maintained by the same health insurance issuer 
                \2\.
---------------------------------------------------------------------------
    \2\ Section 1563 (relating to conforming amendments--originally 
designated as section 1562 and redesignated as section 1563 by section 
10107(b)(1)) of Public Law 111-148 provides for an amendment to insert 
``or, with respect to individual coverage, under any health insurance 
coverage maintained by the same health insurance issuer''. Such 
amendment did not specify where to insert this new language, however, 
it was carried out by inserting this new language before the period at 
the end in order to reflect the probable intent of Congress.
---------------------------------------------------------------------------
            (3) Supplemental excepted benefits.--The 
        requirements of this part shall not apply to any 
        individual coverage or any group health plan (and group 
        health insurance coverage) in relation to its provision 
        of excepted benefits described in section 27971(c)(4) 
        if the benefits are provided under a separate policy, 
        certificate, or contract of insurance.
    (d) Treatment of Partnerships.--For purposes of this part--
            (1) Treatment as a group health plan.--Any plan, 
        fund, or program which would not be (but for this 
        subsection) an employee welfare benefit plan and which 
        is established or maintained by a partnership, to the 
        extent that such plan, fund, or program provides 
        medical care (including items and services paid for as 
        medical care) to present or former partners in the 
        partnership or to their dependents (as defined under 
        the terms of the plan, fund, or program), directly or 
        through insurance, reimbursement, or otherwise, shall 
        be treated (subject to paragraph (2)) as an employee 
        welfare benefit plan which is a group health plan.
            (2) Employer.--In the case of a group health plan, 
        the term ``employer'' also includes the partnership in 
        relation to any partner.
            (3) Participants of group health plans.--In the 
        case of a group health plan, the term ``participant'' 
        also includes--
                    (A) in connection with a group health plan 
                maintained by a partnership, an individual who 
                is a partner in relation to the partnership, or
                    (B) in connection with a group health plan 
                maintained by a self-employed individual (under 
                which one or more employees are participants), 
                the self-employed individual,
        if such individual is, or may become, eligible to 
        receive a benefit under the plan or such individual's 
        beneficiaries may be eligible to receive any such 
        benefit.

SEC. 2723. [300GG-22] ENFORCEMENT.

    (a) State Enforcement.--
            (1) State authority.--Subject to section 2723, each 
        State may require that health insurance issuers that 
        issue, sell, renew, or offer health insurance coverage 
        in the State in the individual or group market meet the 
        requirements of this part with respect to such issuers.
            (2) Failure to implement provisions.--In the case 
        of a determination by the Secretary that a State has 
        failed to substantially enforce a provision (or 
        provisions) in this part with respect to health 
        insurance issuers in the State, the Secretary shall 
        enforce such provision (or provisions) under subsection 
        (b) insofar as they relate to the issuance, sale, 
        renewal, and offering of health insurance coverage in 
        connection with group health plans or individual health 
        insurance coverage in such State.
    (b) Secretarial Enforcement Authority.--
            (1) Limitation.--The provisions of this subsection 
        shall apply to enforcement of a provision (or 
        provisions) of this part only--
                    (A) as provided under subsection (a)(2); 
                and
                    (B) with respect to individual health 
                insurance coverage or group health plans that 
                are non-Federal governmental plans.
            (2) Imposition of penalties.--In the cases 
        described in paragraph (1)--
                    (A) In general.--Subject to the succeeding 
                provisions of this subsection, any non-Federal 
                governmental plan that is a group health plan 
                and any health insurance issuer that fails to 
                meet a provision of this part applicable to 
                such plan or issuer is subject to a civil money 
                penalty under this subsection.
                    (B) Liability for penalty.--In the case of 
                a 
                failure by--
                            (i) a health insurance issuer, the 
                        issuer is liable for such penalty, or
                            (ii) a group health plan that is a 
                        non-Federal governmental plan which 
                        is--
                                    (I) sponsored by 2 or more 
                                employers, the plan is liable 
                                for such penalty, or
                                    (II) not so sponsored, the 
                                employer is liable for such 
                                penalty.
                    (C) Amount of penalty.--
                            (i) In general.--The maximum amount 
                        of penalty imposed under this paragraph 
                        is $100 for each day for each 
                        individual with respect to which such a 
                        failure occurs.
                            (ii) Considerations in 
                        imposition.--In determining the amount 
                        of any penalty to be assessed under 
                        this paragraph, the Secretary shall 
                        take into account the previous record 
                        of compliance of the entity being 
                        assessed with the applicable provisions 
                        of this part and the gravity of the 
                        violation.
                            (iii) Limitations.--
                                    (I) Penalty not to apply 
                                where failure not discovered 
                                exercising reasonable 
                                diligence.--No civil money 
                                penalty shall be imposed under 
                                this paragraph on any failure 
                                during any period for which it 
                                is established to the 
                                satisfaction of the Secretary 
                                that none of the entities 
                                against whom the penalty would 
                                be imposed knew, or exercising 
                                reasonable diligence would have 
                                known, that such failure 
                                existed.
                                    (II) Penalty not to apply 
                                to failures corrected within 30 
                                days.--No civil money penalty 
                                shall be imposed under this 
                                paragraph on any failure if 
                                such failure was due to 
                                reasonable cause and not to 
                                willful neglect, and such 
                                failure is corrected during the 
                                30-day period beginning on the 
                                first day any of the entities 
                                against whom the penalty would 
                                be imposed knew, or exercising 
                                reasonable diligence would have 
                                known, that such failure 
                                existed.
                    (D) Administrative review.--
                            (i) Opportunity for hearing.--The 
                        entity assessed shall be afforded an 
                        opportunity for hearing by the 
                        Secretary upon request made within 30 
                        days after the date of the issuance of 
                        a notice of assessment. In such hearing 
                        the decision shall be made on the 
                        record pursuant to section 554 of title 
                        5, United States Code. If no hearing is 
                        requested, the assessment shall 
                        constitute a final and unappealable 
                        order.
                            (ii) Hearing procedure.--If a 
                        hearing is requested, the initial 
                        agency decision shall be made by an 
                        administrative law judge, and such 
                        decision shall become the final order 
                        unless the Secretary modifies or 
                        vacates the decision. Notice of intent 
                        to modify or vacate the decision of the 
                        administrative law judge shall be 
                        issued to the parties within 30 days 
                        after the date of the decision of the 
                        judge. A final order which takes effect 
                        under this paragraph shall be 
                        subject to review only as provided 
                        under subparagraph (E).
                    (E) Judicial review.--
                            (i) Filing of action for review.--
                        Any entity against whom an order 
                        imposing a civil money penalty has been 
                        entered after an agency hearing under 
                        this paragraph may obtain review by the 
                        United States district court for any 
                        district in which such entity is 
                        located or the United States District 
                        Court for the District of Columbia by 
                        filing a notice of appeal in such court 
                        within 30 days from the date of such 
                        order, and simultaneously sending a 
                        copy of such notice by registered mail 
                        to the Secretary.
                            (ii) Certification of 
                        administrative record.--The Secretary 
                        shall promptly certify and file in such 
                        court the record upon which the penalty 
                        was imposed.
                            (iii) Standard for review.--The 
                        findings of the Secretary shall be set 
                        aside only if found to be unsupported 
                        by substantial evidence as provided by 
                        section 706(2)(E) of title 5, United 
                        States Code.
                            (iv) Appeal.--Any final decision, 
                        order, or judgment of the district 
                        court concerning such review shall be 
                        subject to appeal as provided in 
                        chapter 83 of title 28 of such Code.
                    (F) Failure to pay assessment; maintenance 
                of action.--
                            (i) Failure to pay assessment.--If 
                        any entity fails to pay an assessment 
                        after it has become a final and 
                        unappealable order, or after the court 
                        has entered final judgment in favor of 
                        the Secretary, the Secretary shall 
                        refer the matter to the Attorney 
                        General who shall recover the amount 
                        assessed by action in the appropriate 
                        United States district court.
                            (ii) Nonreviewability.--In such 
                        action the validity and appropriateness 
                        of the final order imposing the penalty 
                        shall not be subject to review.
                    (G) Payment of penalties.--Except as 
                otherwise provided, penalties collected under 
                this paragraph shall be paid to the Secretary 
                (or other officer) imposing the penalty and 
                shall be available without appropriation and 
                until expended for the purpose of enforcing the 
                provisions with respect to which the penalty 
                was imposed.
            (3) Enforcement authority relating to genetic 
        discrimination.--
                    (A) General rule.--In the cases described 
                in paragraph (1), notwithstanding the 
                provisions of paragraph (2)(C), the succeeding 
                subparagraphs of this paragraph shall apply 
                with respect to an action under this subsection 
                by the Secretary with respect to any failure of 
                a health insurance issuer in connection with a 
                group health plan, to meet the requirements of 
                subsection (a)(1)(F), (b)(3), (c), or (d) of 
                section 2702 or section 2701 or 2702(b)(1) with 
                respect to genetic information in connection 
                with the plan.
                    (B) Amount.--
                            (i) In general.--The amount of the 
                        penalty imposed under this paragraph 
                        shall be $100 for each day in the 
                        noncompliance period with respect to 
                        each participant or beneficiary to whom 
                        such failure relates.
                            (ii) Noncompliance period.--For 
                        purposes of this paragraph, the term 
                        ``noncompliance period'' means, with 
                        respect to any failure, the period--
                                    (I) beginning on the date 
                                such failure first occurs; and
                                    (II) ending on the date the 
                                failure is corrected.
                    (C) Minimum penalties where failure 
                discovered.--Notwithstanding clauses (i) and 
                (ii) of subparagraph (D):
                            (i) In general.--In the case of 1 
                        or more failures with respect to an 
                        individual--
                                    (I) which are not corrected 
                                before the date on which the 
                                plan receives a notice from the 
                                Secretary of such violation; 
                                and
                                    (II) which occurred or 
                                continued during the period 
                                involved;
                        the amount of penalty imposed by 
                        subparagraph (A) by reason of such 
                        failures with respect to such 
                        individual shall not be less than 
                        $2,500.
                            (ii) Higher minimum penalty where 
                        violations are more than de minimis.--
                        To the extent violations for which any 
                        person is liable under this paragraph 
                        for any year are more than de minimis, 
                        clause (i) shall be applied by 
                        substituting ``$15,000'' for ``$2,500'' 
                        with respect to such person.
                    (D) Limitations.--
                            (i) Penalty not to apply where 
                        failure not discovered exercising 
                        reasonable diligence.--No penalty shall 
                        be imposed by subparagraph (A) on any 
                        failure during any period for which it 
                        is established to the satisfaction of 
                        the Secretary that the person otherwise 
                        liable for such penalty did not know, 
                        and exercising reasonable diligence 
                        would not have known, that such failure 
                        existed.
                            (ii) Penalty not to apply to 
                        failures corrected within certain 
                        periods.--No penalty shall be imposed 
                        by subparagraph (A) on any failure if--
                                    (I) such failure was due to 
                                reasonable cause and not to 
                                willful neglect; and
                                    (II) such failure is 
                                corrected during the 30-day 
                                period beginning on the first 
                                date the person otherwise 
                                liable for such penalty knew, 
                                or exercising reasonable 
                                diligence would have known, 
                                that such failure existed.
                            (iii) Overall limitation for 
                        unintentional failures.--In the case of 
                        failures which are due to reasonable 
                        cause and not to willful neglect, the 
                        penalty imposed by subparagraph (A) for 
                        failures shall not exceed the amount 
                        equal to the lesser of--
                                    (I) 10 percent of the 
                                aggregate amount paid or 
                                incurred by the employer (or 
                                predecessor employer) during 
                                the preceding taxable year for 
                                group health plans; or
                                    (II) $500,000.
                    (E) Waiver by secretary.--In the case of a 
                failure which is due to reasonable cause and 
                not to willful neglect, the Secretary may waive 
                part or all of the penalty imposed by 
                subparagraph (A) to the extent that the payment 
                of such penalty would be excessive relative to 
                the failure involved.

SEC. 2724. [300GG-23] PREEMPTION; STATE FLEXIBILITY; CONSTRUCTION.

    (a) Continued Applicability of State Law With Respect to 
Health Insurance Issuers.--
            (1) In General.--Subject to paragraph (2) and 
        except as provided in subsection (b), this part and 
        part C insofar as it relates to this part shall not be 
        construed to supersede any provision of State law which 
        establishes, implements, or continues in effect any 
        standard or requirement solely relating to health 
        insurance issuers in connection with individual or 
        group health insurance coverage except to the extent 
        that such standard or requirement prevents the 
        application of a requirement of this part.
            (2) Continued preemption with respect to group 
        health plans.--Nothing in this part shall be construed 
        to affect or modify the provisions of section 514 of 
        the Employee Retirement Income Security Act of 1974 
        with respect to group health plans.
    (b) Special Rules in Case of Portability Requirements.--
            (1) In general.--Subject to paragraph (2), the 
        provisions of this part relating to health insurance 
        coverage offered by a health insurance issuer supersede 
        any provision of State law which establishes, 
        implements, or continues in effect a standard or 
        requirement applicable to imposition of a preexisting 
        condition exclusion specifically governed by section 
        701 which differs from the standards or requirements 
        specified in such section.
            (2) Exceptions.--Only in relation to health 
        insurance coverage offered by a health insurance 
        issuer, the provisions of this part do not supersede 
        any provision of State law to the extent that such 
        provision--
                    (i) \1\ substitutes for the reference to 
                ``6-month period'' in section 2701(a)(1) a 
                reference to any shorter period of time;
---------------------------------------------------------------------------
    \1\ Clauses (i) through (vii) probably should be redesignated as 
subparagraphs (A) through (G). See section 102(a) of Public Law 104-191 
(110 Stat. 1971).
---------------------------------------------------------------------------
                    (ii) \1\ substitutes for the reference to 
                ``12 months'' and ``18 months'' in section 
                2701(a)(2) a reference to any shorter period of 
                time;
                    (iii) \1\ substitutes for the references to 
                ``63'' days in sections 2701(c)(2)(A) and 
                2701(d)(4)(A) a reference to any greater number 
                of days;
                    (iv) \1\ substitutes for the reference to 
                ``30-day period'' in sections 2701(b)(2) and 
                2701(d)(1) a reference to any greater period;
                    (v) \1\ prohibits the imposition of any 
                preexisting condition exclusion in cases not 
                described in section 2701(d) or expands the 
                exceptions described in such section;
                    (vi) \1\ requires special enrollment 
                periods in addition to those required under 
                section 2701(f); or
                    (vii) \1\ reduces the maximum period 
                permitted in an affiliation period under 
                section 2701(g)(1)(B).
    (c) Rules of Construction.--Nothing in this part (other 
than section 2704) shall be construed as requiring a group 
health plan or health insurance coverage to provide specific 
benefits under the terms of such plan or coverage.
    (d) Definitions.--For purposes of this section--
            (1) State law.--The term ``State law'' includes all 
        laws, decisions, rules, regulations, or other State 
        action having the effect of law, of any State. A law of 
        the United States applicable only to the District of 
        Columbia shall be treated as a State law rather than a 
        law of the United States.
            (2) State.--The term ``State'' includes a State 
        (including the Northern Mariana Islands), any political 
        subdivisions of a State or such Islands, or any agency 
        or instrumentality of either. \2\
---------------------------------------------------------------------------
    \2\ See footnote accompanying section 2725 regarding ambiguity in 
placement of sections 2725-2728.

=======================================================================


                  Part B--Individual Market Rules \1\

     Subpart 1--Portability, Access, and Renewability Requirements

SEC. 2741. [300GG-41] GUARANTEED AVAILABILITY OF INDIVIDUAL HEALTH 
                    INSURANCE COVERAGE TO CERTAIN INDIVIDUALS WITH 
                    PRIOR GROUP COVERAGE.

    (a) Guaranteed Availability.--
            (1) In general.--Subject to the succeeding 
        subsections of this section and section 2744, each 
        health insurance issuer that offers health insurance 
        coverage (as defined in section 2791(b)(1)) in the 
        individual market in a State may not, with respect to 
        an eligible individual (as defined in subsection (b)) 
        desiring to enroll in individual health insurance 
        coverage--
---------------------------------------------------------------------------
    \1\ Section 111(b) of Public Law 104-191 (110 Stat. 1987) provides 
as follows:
    ``(b) Effective Date.--
---------------------------------------------------------------------------

          ``(1) In general.--Except as provided in this subsection, 
        part B of title XXVII of the Public Health Service Act (as 
        inserted by subsection (a)) shall apply with respect to health 
        insurance coverage offered, sold, issued, renewed, in effect, 
        or operated in the individual market after June 30, 1997, 
        regardless of when a period of creditable coverage occurs.
          ``(2) Application of certification rules.--The provisions of 
        section 102(d)(2) of this Act shall apply to section 2743 of 
        the the Public Health Service Act in the same manner as it 
        applies to section 2701(e) [redesignated as section 2704(e) by 
        P.L. 111-148] of such Act.''.
---------------------------------------------------------------------------
    With respect to paragraph (2) of such section 111(b), subsection 
(d) of section 102 of Public Law 104-191 is not divided into paragraphs 
(1) and (2) (and the subsection relates to a technical correction). 
Subsection (c)(2) of such section 102 does relate to certifications.
---------------------------------------------------------------------------
                    (A) decline to offer such coverage to, or 
                deny enrollment of, such individual; or
                    (B) impose any preexisting condition 
                exclusion (as defined in section 2701(b)(1)(A)) 
                with respect to such coverage.
            (2) Substitution by state of acceptable alternative 
        mechanism.--The requirement of paragraph (1) shall not 
        apply to health insurance coverage offered in the 
        individual market in a State in which the State is 
        implementing an acceptable alternative mechanism under 
        section 2744.
    (b) Eligible Individual Defined.--In this part, the term 
``eligible individual'' means an individual--
            (1)(A) for whom, as of the date on which the 
        individual seeks coverage under this section, the 
        aggregate of the periods of creditable coverage (as 
        defined in section 2701(c)) is 18 or more months and 
        (B) whose most recent prior creditable coverage was 
        under a group health plan, governmental plan, or church 
        plan (or health insurance coverage offered in 
        connection with any such plan);
            (2) who is not eligible for coverage under (A) a 
        group health plan, (B) part A or part B of title XVIII 
        of the Social Security Act, or (C) a State plan under 
        title XIX of such Act (or any successor program), and 
        does not have other health insurance coverage;
            (3) with respect to whom the most recent coverage 
        within the coverage period described in paragraph 
        (1)(A) was not terminated based on a factor described 
        in paragraph (1) or (2) of section 2712(b) (relating to 
        nonpayment of premiums or fraud);
            (4) if the individual had been offered the option 
        of continuation coverage under a COBRA continuation 
        provision or under a similar State program, who elected 
        such coverage; and
            (5) who, if the individual elected such 
        continuation coverage, has exhausted such continuation 
        coverage under such provision or program.
    (c) Alternative Coverage Permitted Where No State 
Mechanism.--
            (1) In general.--In the case of health insurance 
        coverage offered in the individual market in a State in 
        which the State is not implementing an acceptable 
        alternative mechanism under section 2744, the health 
        insurance issuer may elect to limit the coverage 
        offered under subsection (a) so long as it offers at 
        least two different policy forms of health insurance 
        coverage both of which--
                    (A) are designed for, made generally 
                available to, and actively marketed to, and 
                enroll both eligible and other individuals by 
                the issuer; and
                    (B) meet the requirement of paragraph (2) 
                or (3), as elected by the issuer.
        For purposes of this subsection, policy forms which 
        have different cost-sharing arrangements or different 
        riders shall be considered to be different policy 
        forms.
            (2) Choice of most popular policy forms.--The 
        requirement of this paragraph is met, for health 
        insurance coverage policy forms offered by an issuer in 
        the individual market, if the issuer offers the policy 
        forms for individual health insurance coverage with the 
        largest, and next to largest, premium volume of all 
        such policy forms offered by the issuer in the State or 
        applicable marketing or service area (as may be 
        prescribed in regulation) by the issuer in the 
        individual market in the period involved.
            (3) Choice of 2 policy forms with representative 
        coverage.--
                    (A) In general.--The requirement of this 
                paragraph is met, for health insurance coverage 
                policy forms offered by an issuer in the 
                individual market, if the issuer offers a 
                lower-level coverage policy form (as defined in 
                subparagraph (B)) and a higher-level coverage 
                policy form (as defined in subparagraph (C)) 
                each of which includes benefits substantially 
                similar to other individual health insurance 
                coverage offered by the issuer in that State 
                and each of which is covered under a method 
                described in section 2744(c)(3)(A) (relating to 
                risk adjustment, risk spreading, or financial 
                subsidization).
                    (B) Lower-level of coverage described.--A 
                policy form is described in this subparagraph 
                if the actuarial value of the benefits under 
                the coverage is at least 85 percent but not 
                greater than 100 percent of a weighted average 
                (described in subparagraph (D)).
                    (C) Higher-level of coverage described.--A 
                policy form is described in this subparagraph 
                if--
                            (i) the actuarial value of the 
                        benefits under the coverage is at least 
                        15 percent greater than the actuarial 
                        value of the coverage described in 
                        subparagraph (B) offered by the issuer 
                        in the area involved; and
                            (ii) the actuarial value of the 
                        benefits under the coverage is at least 
                        100 percent but not greater than 120 
                        percent of a weighted average 
                        (described in subparagraph (D)).
                    (D) Weighted average.--For purposes of this 

                paragraph, the weighted average described in 
                this subparagraph is the average actuarial 
                value of the benefits provided by all the 
                health insurance coverage issued (as elected by 
                the issuer) either by that issuer or by all 
                issuers in the State in the individual market 
                during the previous year (not including 
                coverage issued under this section), weighted 
                by enrollment for the different coverage.
            (4) Election.--The issuer elections under this 
        subsection shall apply uniformly to all eligible 
        individuals in the State for that issuer. Such an 
        election shall be effective for policies offered during 
        a period of not shorter than 2 years.
            (5) Assumptions.--For purposes of paragraph (3), 
        the actuarial value of benefits provided under 
        individual health insurance coverage shall be 
        calculated based on a standardized population and a set 
        of standardized utilization and cost factors.
    (d) Special Rules for Network Plans.--
            (1) In general.--In the case of a health insurance 
        issuer that offers health insurance coverage in the 
        individual market through a network plan, the issuer 
        may--
                    (A) limit the individuals who may be 
                enrolled under such coverage to those who live, 
                reside, or work within the service area for 
                such network plan; and
                    (B) within the service area of such plan, 
                deny such coverage to such individuals if the 
                issuer has demonstrated, if required, to the 
                applicable State authority that--
                            (i) it will not have the capacity 
                        to deliver services adequately to 
                        additional individual enrollees because 
                        of its obligations to existing group 
                        contract holders and enrollees and 
                        individual enrollees, and
                            (ii) it is applying this paragraph 
                        uniformly to individuals without regard 
                        to any health status-related factor of 
                        such individuals and without regard to 
                        whether the individuals are eligible 
                        individuals.
            (2) 180-day suspension upon denial of coverage.--An 
        issuer, upon denying health insurance coverage in any 
        service area in accordance with paragraph (1)(B), may 
        not offer coverage in the individual market within such 
        service area for a period of 180 days after such 
        coverage is denied.
    (e) Application of Financial Capacity Limits.--
            (1) In general.--A health insurance issuer may deny 
        health insurance coverage in the individual market to 
        an eligible individual if the issuer has demonstrated, 
        if required, to the applicable State authority that--
                    (A) it does not have the financial reserves 
                necessary to underwrite additional coverage; 
                and
                    (B) it is applying this paragraph uniformly 
                to all individuals in the individual market in 
                the State consistent with applicable State law 
                and without regard to any health status-related 
                factor of such individuals and without regard 
                to whether the individuals are eligible 
                individuals.
            (2) 180-day suspension upon denial of coverage.--An 
        issuer upon denying individual health insurance 
        coverage in any service area in accordance with 
        paragraph (1) may not offer such coverage in the 
        individual market within such service area for a period 
        of 180 days after the date such coverage is denied or 
        until the issuer has demonstrated, if required under 
        applicable State law, to the applicable State authority 
        that the issuer has sufficient financial reserves to 
        underwrite additional coverage, whichever is later. A 
        State may provide for the application of this paragraph 
        on a service-area-specific basis.
    (e) \1\ Market Requirements.--
---------------------------------------------------------------------------
    \1\ So in law. Probably should redesignate the second subsection 
(e) and subsection (f) as subsections (f) and (g), respectively. See 
section 111(a) of Pub. L. 104-191 (110 Stat. 1978).
---------------------------------------------------------------------------
            (1) In general.--The provisions of subsection (a) 
        shall not be construed to require that a health 
        insurance issuer offering health insurance coverage 
        only in connection with group health plans or through 
        one or more bona fide associations, or both, offer such 
        health insurance coverage in the individual market.
            (2) Conversion policies.--A health insurance issuer 
        offering health insurance coverage in connection with 
        group health plans under this title shall not be deemed 
        to be a health insurance issuer offering individual 
        health insurance coverage solely because such issuer 
        offers a conversion policy.
    (f) \1\ Construction.--Nothing in this section shall be 
construed--
            (1) to restrict the amount of the premium rates 
        that an issuer may charge an individual for health 
        insurance coverage provided in the individual market 
        under applicable State law; or
            (2) to prevent a health insurance issuer offering 
        health insurance coverage in the individual market from 
        establishing premium discounts or rebates or modifying 
        otherwise applicable copayments or deductibles in 
        return for adherence to programs of health promotion 
        and disease prevention.

SEC. 2742. [300GG-42] GUARANTEED RENEWABILITY OF INDIVIDUAL HEALTH 
                    INSURANCE COVERAGE.

    (a) In General.--Except as provided in this section, a 
health insurance issuer that provides individual health 
insurance coverage to an individual shall renew or continue in 
force such coverage at the option of the individual.
    (b) General Exceptions.--A health insurance issuer may 
nonrenew or discontinue health insurance coverage of an 
individual in the individual market based only on one or more 
of the following:
            (1) Nonpayment of premiums.--The individual has 
        failed to pay premiums or contributions in accordance 
        with the terms of the health insurance coverage or the 
        issuer has not received timely premium payments.
            (2) Fraud.--The individual has performed an act or 
        practice that constitutes fraud or made an intentional 
        misrepresentation of material fact under the terms of 
        the coverage.
            (3) Termination of plan.--The issuer is ceasing to 
        offer coverage in the individual market in accordance 
        with subsection (c) and applicable State law.
            (4) Movement outside service area.--In the case of 
        a health insurance issuer that offers health insurance 
        coverage in the market through a network plan, the 
        individual no longer resides, lives, or works in the 
        service area (or in an area for which the issuer is 
        authorized to do business) but only if such coverage is 
        terminated under this paragraph uniformly without 
        regard to any health status-related factor of covered 
        individuals.
            (5) Association membership ceases.--In the case of 
        health insurance coverage that is made available in the 
        individual market only through one or more bona fide 
        associations, the membership of the individual in the 
        association (on the basis of which the coverage is 
        provided) ceases but only if such coverage is 
        terminated under this paragraph uniformly without 
        regard to any health status-related factor of covered 
        individuals.
    (c) Requirements for Uniform Termination of Coverage.--
            (1) Particular type of coverage not offered.--In 
        any case in which an issuer decides to discontinue 
        offering a particular type of health insurance coverage 
        offered in the individual market, coverage of such type 
        may be discontinued by the issuer only if--
                    (A) the issuer provides notice to each 
                covered individual provided coverage of this 
                type in such market of such discontinuation at 
                least 90 days prior to the date of the 
                discontinuation of such coverage;
                    (B) the issuer offers to each individual in 
                the individual market provided coverage of this 
                type, the option to purchase any other 
                individual health insurance coverage currently 
                being offered by the issuer for individuals in 
                such market; and
                    (C) in exercising the option to discontinue 
                coverage of this type and in offering the 
                option of coverage under subparagraph (B), the 
                issuer acts uniformly without regard to any 
                health status-related factor of enrolled 
                individuals or individuals who may become 
                eligible for such coverage.
            (2) Discontinuance of all coverage.--
                    (A) In general.--Subject to subparagraph 
                (C), in any case in which a health insurance 
                issuer elects to discontinue offering all 
                health insurance coverage in the individual 
                market in a State, health insurance coverage 
                may be discontinued by the issuer only if--
                            (i) the issuer provides notice to 
                        the applicable State authority and to 
                        each individual of such discontinuation 
                        at least 180 days prior to the date of 
                        the expiration of such coverage, and
                            (ii) all health insurance issued or 
                        delivered for issuance in the State in 
                        such market are discontinued and 
                        coverage under such health insurance 
                        coverage in such market is not renewed.
                    (B) Prohibition on market reentry.--In the 
                case of a discontinuation under subparagraph 
                (A) in the individual market, the issuer may 
                not provide for the issuance of any health 
                insurance coverage in the market and State 
                involved during the 5-year period beginning on 
                the date of the discontinuation of the last 
                health insurance coverage not so renewed.
    (d) Exception for Uniform Modification of Coverage.--At the 
time of coverage renewal, a health insurance issuer may modify 
the health insurance coverage for a policy form offered to 
individuals in the individual market so long as such 
modification is consistent with State law and effective on a 
uniform basis among all individuals with that policy form.
    (e) Application to Coverage Offered Only Through 
Associations.--In applying this section in the case of health 
insurance coverage that is made available by a health insurance 
issuer in the individual market to individuals only through one 
or more associations, a reference to an ``individual'' is 
deemed to include a reference to such an association (of which 
the individual is a member).

SEC. 2743. [300GG-43] CERTIFICATION OF COVERAGE.

    The provisions of section 2701(e) shall apply to health 
insurance coverage offered by a health insurance issuer in the 
individual market in the same manner as it applies to health 
insurance coverage offered by a health insurance issuer in 
connection with a group health plan in the small or large group 
market.

SEC. 2744. [300GG-44] STATE FLEXIBILITY IN INDIVIDUAL MARKET REFORMS.

    (a) Waiver of Requirements Where Implementation of 
Acceptable Alternative Mechanism.--
            (1) In general.--The requirements of section 2741 
        shall not apply with respect to health insurance 
        coverage offered in the individual market in the State 
        so long as a State is found to be implementing, in 
        accordance with this section and consistent with 
        section 2762(b), an alternative mechanism (in this 
        section referred to as an ``acceptable alternative 
        mechanism'')--
                    (A) under which all eligible individuals 
                are provided a choice of health insurance 
                coverage;
                    (B) under which such coverage does not 
                impose any preexisting condition exclusion with 
                respect to such coverage;
                    (C) under which such choice of coverage 
                includes at least one policy form of coverage 
                that is comparable to comprehensive health 
                insurance coverage offered in the individual 
                market in such State or that is comparable to a 
                standard option of coverage available under the 
                group or individual health insurance laws of 
                such State; and
                    (D) in a State which is implementing--
                            (i) a model act described in 
                        subsection (c)(1),
                            (ii) a qualified high risk pool 
                        described in subsection (c)(2), or
                            (iii) a mechanism described in 
                        subsection (c)(3).
            (2) Permissible Forms of mechanisms.--A private or 
        public individual health insurance mechanism (such as a 
        health insurance coverage pool or programs, mandatory 
        group conversion policies, guaranteed issue of one or 
        more plans of individual health insurance coverage, or 
        open enrollment by one or more health insurance 
        issuers), or combination of such mechanisms, that is 
        designed to provide access to health benefits for 
        individuals in the individual market in the State in 
        accordance with this section may constitute an 
        acceptable alternative mechanism.
    (b) Application of Acceptable Alternative Mechanisms.--
            (1) Presumption.--
                    (A) In general.--Subject to the succeeding 
                provisions of this subsection, a State is 
                presumed to be implementing an acceptable 
                alternative mechanism in accordance with this 
                section as of July 1, 1997, if, by not later 
                than April 1, 1997, the chief executive officer 
                of a State--
                            (i) notifies the Secretary that the 
                        State has enacted or intends to enact 
                        (by not later than January 1, 1998, or 
                        July 1, 1998, in the case of a State 
                        described in subparagraph (B)(ii)) any 
                        necessary legislation to provide for 
                        the implementation of a mechanism 
                        reasonably designed to be an acceptable 
                        alternative mechanism as of January 1, 
                        1998, (or, in the case of a State 
                        described in subparagraph (B)(ii), July 
                        1, 1998); and
                            (ii) provides the Secretary with 
                        such information as the Secretary may 
                        require to review the mechanism and its 
                        implementation (or proposed 
                        implementation) under this subsection.
                    (B) Delay permitted for certain states.--
                            (i) Effect of delay.--In the case 
                        of a State described in clause (ii) 
                        that provides notice under subparagraph 
                        (A)(i), for the presumption to continue 
                        on and after July 1, 1998, the chief 
                        executive officer of the State by April 
                        1, 1998--
                                    (I) must notify the 
                                Secretary that the State has 
                                enacted any necessary 
                                legislation to provide for the 
                                implementation of a mechanism 
                                reasonably designed to be an 
                                acceptable alternative 
                                mechanism as of July 1, 1998; 
                                and
                                    (II) must provide the 
                                Secretary with such information 
                                as the Secretary may require to 
                                review the mechanism and its 
                                implementation (or proposed 
                                implementation) under this 
                                subsection.
                            (ii) States described.--A State 
                        described in this clause is a State 
                        that has a legislature that does not 
                        meet within the 12-month period 
                        beginning on the date of enactment of 
                        this Act.
                    (C) Continued application.--In order for a 
                mechanism to continue to be presumed to be an 
                acceptable alternative mechanism, the State 
                shall provide the Secretary every 3 years with 
                information described in subparagraph (A)(ii) 
                or (B)(i)(II) (as the case may be).
            (2) Notice.--If the Secretary finds, after review 
        of information provided under paragraph (1) and in 
        consultation with the chief executive officer of the 
        State and the insurance commissioner or chief insurance 
        regulatory official of the State, that such a mechanism 
        is not an acceptable alternative mechanism or is not 
        (or no longer) being implemented, the Secretary--
                    (A) shall notify the State of--
                            (i) such preliminary determination, 
                        and
                            (ii) the consequences under 
                        paragraph (3) of a failure to implement 
                        such a mechanism; and
                    (B) shall permit the State a reasonable 
                opportunity in which to modify the mechanism 
                (or to adopt another mechanism) in a manner so 
                that may be an acceptable alternative mechanism 
                or to provide for implementation of such a 
                mechanism.
            (3) Final determination.--If, after providing 
        notice and opportunity under paragraph (2), the 
        Secretary finds that the mechanism is not an acceptable 
        alternative mechanism or the State is not implementing 
        such a mechanism, the Secretary shall notify the State 
        that the State is no longer considered to be 
        implementing an acceptable alternative mechanism and 
        that the requirements of section 2741 shall apply to 
        health insurance coverage offered in the individual 
        market in the State, effective as of a date specified 
        in the notice.
            (4) Limitation on secretarial authority.--The 
        Secretary shall not make a determination under 
        paragraph (2) or (3) on any basis other than the basis 
        that a mechanism is not an acceptable alternative 
        mechanism or is not being implemented.
            (5) Future adoption of mechanisms.--If a State, 
        after January 1, 1997, submits the notice and 
        information described in paragraph (1), unless the 
        Secretary makes a finding described in paragraph (3) 
        within the 90-day period beginning on the date of 
        submission of the notice and information, the mechanism 
        shall be considered to be an acceptable alternative 
        mechanism for purposes of this section, effective 90 
        days after the end of such period, subject to the 
        second sentence of paragraph (1).
    (c) Provision Related to Risk.--
            (1) Adoption of naic models.--The model act 
        referred to in subsection (a)(1)(D)(i) is the Small 
        Employer and Individual Health Insurance Availability 
        Model Act (adopted by the National Association of 
        Insurance Commissioners on June 3, 1996) insofar as it 
        applies to individual health insurance coverage or the 
        Individual Health Insurance Portability Model Act (also 
        adopted by such Association on such date).
            (2) Qualified high risk pool.--For purposes of 
        subsection (a)(1)(D)(ii), a ``qualified high risk 
        pool'' described in this paragraph is a high risk pool 
        that--
                    (A) provides to all eligible individuals 
                health insurance coverage (or comparable 
                coverage) that does not impose any preexisting 
                condition exclusion with respect to such 
                coverage for all eligible individuals, and
                    (B) provides for premium rates and covered 
                benefits for such coverage consistent with 
                standards included in the NAIC Model Health 
                Plan for Uninsurable Individuals Act (as in 
                effect as of the date of the enactment of this 
                title).
            (3) Other mechanisms.--For purposes of subsection 
        (a)(1)(D)(iii), a mechanism described in this 
        paragraph--
                    (A) provides for risk adjustment, risk 
                spreading, or a risk spreading mechanism (among 
                issuers or policies of an issuer) or otherwise 
                provides for some financial subsidization for 
                eligible individuals, including through 
                assistance to participating issuers; or
                    (B) is a mechanism under which each 
                eligible individual is provided a choice of all 
                individual health insurance coverage otherwise 
                available.

SEC. 2745. [300GG-45] RELIEF FOR HIGH RISK POOLS.

    (a) Seed Grants to States.--The Secretary shall provide 
from the funds appropriated under subsection (d)(1)(A) a grant 
of up to $1,000,000 to each State that has not created a 
qualified high risk pool as of the date of enactment of the 
State High Risk Pool Funding Extension Act of 2006 for the 
State's costs of creation and initial operation of such a pool.
    (b) Grants for Operational Losses.--
            (1) In general.--In the case of a State that has 
        established a qualified high risk pool that--
                    (A) restricts premiums charged under the 
                pool to no more than 200 percent of the premium 
                for applicable standard risk rates;
                    (B) offers a choice of two or more coverage 
                options through the pool; and
                    (C) has in effect a mechanism reasonably 
                designed to ensure continued funding of losses 
                incurred by the State in connection with 
                operation of the pool after the end of the last 
                fiscal year for which a grant is provided under 
                this paragraph;
        the Secretary shall provide, from the funds 
        appropriated under paragraphs (1)(B)(i) and (2)(A) of 
        subsection (d) and allotted to the State under 
        paragraph (2), a grant for the losses incurred by the 
        State in connection with the operation of the pool.
            (2) Allotment.--Subject to paragraph (4), the 
        amounts appropriated under paragraphs (1)(B)(i) and 
        (2)(A) of subsection (d) for a fiscal year shall be 
        allotted and made available to the States (or the 
        entities that operate the high risk pool under 
        applicable State law) that qualify for a grant under 
        paragraph (1) as follows:
                    (A) An amount equal to 40 percent of such 
                appropriated amount for the fiscal year shall 
                be allotted in equal amounts to each qualifying 
                State that is one of the 50 States or the 
                District of Columbia and that applies for a 
                grant under this subsection.
                    (B) An amount equal to 30 percent of such 
                appropriated amount for the fiscal year shall 
                be allotted among qualifying States that apply 
                for such a grant so that the amount allotted to 
                such a State bears the same ratio to such 
                appropriated amount as the number of uninsured 
                individuals in the State bears to the total 
                number of uninsured individuals (as determined 
                by the Secretary) in all qualifying States that 
                so apply.
                    (C) An amount equal to 30 percent of such 
                appropriated amount for the fiscal year shall 
                be allotted among qualifying States that apply 
                for such a grant so that the amount allotted to 
                a State bears the same ratio to such 
                appropriated amount as the number of 
                individuals enrolled in health care coverage 
                through the qualified high risk pool of the 
                State bears to the total number of individuals 
                so enrolled through qualified high risk pools 
                (as determined by the Secretary) in all 
                qualifying States that so apply.
            (3) Special rule for pools charging higher 
        premiums.--In the case of a qualified high risk pool of 
        a State which charges premiums that exceed 150 percent 
        of the premium for applicable standard risks, the State 
        shall use at least 50 percent of the amount of the 
        grant provided to the State to carry out this 
        subsection to reduce premiums for enrollees.
            (4) Limitation for territories.--In no case shall 
        the aggregate amount allotted and made available under 
        paragraph (2) for a fiscal year to States that are not 
        the 50 States or the District of Columbia exceed 
        $1,000,000.
    (c) Bonus Grants for Supplemental Consumer Benefits.--
            (1) In general.--In the case of a State that is one 
        of the 50 States or the District of Columbia, that has 
        established a qualified high risk pool, and that is 
        receiving a grant under subsection (b)(1), the 
        Secretary shall provide, from the funds appropriated 
        under paragraphs (1)(B)(ii) and (2)(B) of subsection 
        (d) and allotted to the State under paragraph (3), a 
        grant to be used to provide supplemental consumer 
        benefits to enrollees or potential enrollees (or 
        defined subsets of such enrollees or potential 
        enrollees) in qualified high risk pools.
            (2) Benefits.--A State shall use amounts received 
        under a grant under this subsection to provide one or 
        more of the following benefits:
                    (A) Low-income premium subsidies.
                    (B) A reduction in premium trends, actual 
                premiums, or other cost-sharing requirements.
                    (C) An expansion or broadening of the pool 
                of individuals eligible for coverage, such as 
                through eliminating waiting lists, increasing 
                enrollment caps, or providing flexibility in 
                enrollment rules.
                    (D) Less stringent rules, or additional 
                waiver authority, with respect to coverage of 
                pre-existing conditions.
                    (E) Increased benefits.
                    (F) The establishment of disease management 
                programs.
            (3) Allotment; limitation.--The Secretary shall 
        allot funds appropriated under paragraphs (1)(B)(ii) 
        and (2)(B) of subsection (d) among States qualifying 
        for a grant under paragraph (1) in a manner specified 
        by the Secretary, but in no case shall the amount so 
        allotted to a State for a fiscal year exceed 10 percent 
        of the funds so appropriated for the fiscal year.
            (4) Rule of construction.--Nothing in this 
        subsection shall be construed to prohibit a State that, 
        on the date of the enactment of the State High Risk 
        Pool Funding Extension Act of 2006, is in the process 
        of implementing a program to provide benefits of the 
        type described in paragraph (2), from being eligible 
        for a grant under this subsection.
    (d) Funding.--
            (1) Appropriation for fiscal year 2006.--There are 
        authorized to be appropriated for fiscal year 2006--
                    (A) $15,000,000 to carry out subsection 
                (a); and
                    (B) $75,000,000, of which, subject to 
                paragraph (4)--
                            (i) two-thirds of the amount 
                        appropriated shall be made available 
                        for allotments under subsection (b)(2); 
                        and
                            (ii) one-third of the amount 
                        appropriated shall be made available 
                        for allotments under subsection (c)(3).
            (2) Authorization of appropriations for fiscal 
        years 2007 through 2010.--There are authorized to be 
        appropriated $75,000,000 for each of fiscal years 2007 
        through 2010, of which, subject to paragraph (4)--
                    (A) two-thirds of the amount appropriated 
                for a fiscal year shall be made available for 
                allotments under subsection (b)(2); and
                    (B) one-third of the amount appropriated 
                for a fiscal year shall be made available for 
                allotments under subsection (c)(3).
            (3) Availability.--Funds appropriated for purposes 
        of carrying out this section for a fiscal year shall 
        remain available for obligation through the end of the 
        following fiscal year.
            (4) Reallotment.--If, on June 30 of each fiscal 
        year for which funds are appropriated under paragraph 
        (1)(B) or (2), the Secretary determines that all the 
        amounts so appropriated are not allotted or otherwise 
        made available to States, such remaining amounts shall 
        be allotted and made available under subsection (b) 
        among States receiving grants under subsection (b) for 
        the fiscal year based upon the allotment formula 
        specified in such subsection.
            (5) No entitlement.--Nothing in this section shall 
        be construed as providing a State with an entitlement 
        to a grant under this section.
    (e) Applications.--To be eligible for a grant under this 
section, a State shall submit to the Secretary an application 
at such time, in such manner, and containing such information 
as the Secretary may require.
    (f) Annual Report.--The Secretary shall submit to Congress 
an annual report on grants provided under this section. Each 
such report shall include information on the distribution of 
such grants among States and the use of grant funds by States.
    (g) Definitions.--In this section:
            (1) Qualified high risk pool.--
                    (A) In general.--The term ``qualified high 
                risk pool'' has the meaning given such term in 
                section 2744(c)(2), except that a State may 
                elect to meet the requirement of subparagraph 
                (A) of such section (insofar as it requires the 
                provision of coverage to all eligible 
                individuals) through providing for the 
                enrollment of eligible individuals through an 
                acceptable alternative mechanism (as defined 
                for purposes of section 2744) that includes a 
                high risk pool as a component.
            (2) Standard risk rate.--The term ``standard risk 
        rate'' means a rate--
                    (A) determined under the State high risk 
                pool by considering the premium rates charged 
                by other health insurers offering health 
                insurance coverage to individuals in the 
                insurance market served;
                    (B) that is established using reasonable 
                actuarial techniques; and
                    (C) that reflects anticipated claims 
                experience and expenses for the coverage 
                involved.
            (3) State.--The term ``State'' means any of the 50 
        States and the District of Columbia and includes Puerto 
        Rico, the Virgin Islands, Guam, American Samoa, and the 
        Northern Mariana Islands.

                     Subpart 2--Other Requirements

SEC. 2751. [300GG-51] STANDARDS RELATING TO BENEFITS FOR MOTHERS AND 
                    NEWBORNS.

    (a) In General.--The provisions of section 2704 (other than 
subsections (d) and (f)) shall apply to health insurance 
coverage offered by a health insurance issuer in the individual 
market in the same manner as it applies to health insurance 
coverage offered by a health insurance issuer in connection 
with a group health plan in the small or large group market.
    (b) Notice Requirement.--A health insurance issuer under 
this part shall comply with the notice requirement under 
section 711(d) of the Employee Retirement Income Security Act 
of 1974 with respect to the requirements referred to in 
subsection (a) as if such section applied to such issuer and 
such issuer were a group health plan.
    (c) Preemption; Exception for Health Insurance 
Coverage in Certain States.--
            (1) In general.--The requirements of this section 
        shall not apply with respect to health insurance 
        coverage if there is a State law (as defined in section 
        2723(d)(1)) for a State that regulates such coverage 
        that is described in any of the following 
        subparagraphs:
                    (A) Such State law requires such coverage 
                to provide for at least a 48-hour hospital 
                length of stay following a normal vaginal 
                delivery and at least a 96-hour hospital length 
                of stay following a cesarean section.
                    (B) Such State law requires such coverage 
                to provide for maternity and pediatric care in 
                accordance with guidelines established by the 
                American College of Obstetricians and 
                Gynecologists, the American Academy of 
                Pediatrics, or other established professional 
                medical associations.
                    (C) Such State law requires, in connection 
                with such coverage for maternity care, that the 
                hospital length of stay for such care is left 
                to the decision of (or required to be made by) 
                the attending provider in consultation with the 
                mother.
            (2) Construction.--Section 2762(a) shall not be 
        construed as superseding a State law described in 
        paragraph (1).

SEC. 2752. [300GG-52] REQUIRED COVERAGE FOR RECONSTRUCTIVE SURGERY 
                    FOLLOWING MASTECTOMIES. \1\

    The provisions of section 2706 shall apply to health 
insurance coverage offered by a health insurance issuer in the 
individual market in the same manner as they apply to health 
insurance coverage offered by a health insurance issuer in 
connection with a group health plan in the small or large group 
market.
---------------------------------------------------------------------------
    \1\ Section 2752 was added by subsection (b) of section 903 of the 
Departments of Labor, Health and Human Services, and Education, and 
Related Agencies Appropriations Act, 1999 (as contained in section 
101(f) of division A of Public Law 105-277 (112 Stat. 2681-438)). 
Subsection (c) of such section 903 concerns effective dates, and 
paragraph (2) of the subsection provides as follows:
---------------------------------------------------------------------------

          ``(2) Individual plans.--The amendment made by subsection (b) 
        shall apply with respect to health insurance coverage offered, 
        sold, issued, renewed, in effect, or operated in the individual 
        market on or after the date of enactment of this Act.''.
---------------------------------------------------------------------------
    The Public Law was enacted October 21, 1998.
---------------------------------------------------------------------------

SEC. 2753. \2\ [300GG-53] PROHIBITION OF HEALTH DISCRIMINATION ON THE 
                    BASIS OF GENETIC INFORMATION.
---------------------------------------------------------------------------

    \2\ Another section designated as section 2753 appears at the end 
of part B. There are details in a footnote regarding its placement at 
the end.
---------------------------------------------------------------------------
    (a) Prohibition on Genetic Information as a Condition of 
Eligibility.--
            (1) In general.--A health insurance issuer offering 
        health insurance coverage in the individual market may 
        not establish rules for the eligibility (including 
        continued eligibility) of any individual to enroll in 
        individual health insurance coverage based on genetic 
        information.
            (2) Rule of construction.--Nothing in paragraph (1) 
        or in paragraphs (1) and (2) of subsection (e) shall be 
        construed to preclude a health insurance issuer from 
        establishing rules for eligibility for an individual to 
        enroll in individual health insurance coverage based on 
        the manifestation of a disease or disorder in that 
        individual, or in a family member of such individual 
        where such family member is covered under the policy 
        that covers such individual.
    (b) Prohibition on Genetic Information in Setting Premium 
Rates.--
            (1) In general.--A health insurance issuer offering 
        health insurance coverage in the individual market 
        shall not adjust premium or contribution amounts for an 
        individual on the basis of genetic information 
        concerning the individual or a family member of the 
        individual.
            (2) Rule of construction.--Nothing in paragraph (1) 
        or in paragraphs (1) and (2) of subsection (e) shall be 
        construed to preclude a health insurance issuer from 
        adjusting premium or contribution amounts for an 
        individual on the basis of a manifestation of a disease 
        or disorder in that individual, or in a family member 
        of such individual where such family member is covered 
        under the policy that covers such individual. In such 
        case, the manifestation of a disease or disorder in one 
        individual cannot also be used as genetic information 
        about other individuals covered under the policy issued 
        to such individual and to further increase premiums or 
        contribution amounts.
    (c) Prohibition on Genetic Information as Preexisting 
Condition.--
            (1) In general.--A health insurance issuer offering 
        health insurance coverage in the individual market may 
        not, on the basis of genetic information, impose any 
        preexisting condition exclusion (as defined in section 
        2701(b)(1)(A)) with respect to such coverage.
            (2) Rule of construction.--Nothing in paragraph (1) 
        or in paragraphs (1) and (2) of subsection (e) shall be 
        construed to preclude a health insurance issuer from 
        imposing any preexisting condition exclusion for an 
        individual with respect to health insurance coverage on 
        the basis of a manifestation of a disease or disorder 
        in that individual.
    (d) Genetic Testing.--
            (1) Limitation on requesting or requiring genetic 
        testing.--A health insurance issuer offering health 
        insurance coverage in the individual market shall not 
        request or require an individual or a family member of 
        such individual to undergo a genetic test.
            (2) Rule of construction.--Paragraph (1) shall not 
        be construed to limit the authority of a health care 
        professional who is providing health care services to 
        an individual to request that such individual undergo a 
        genetic test.
            (3) Rule of construction regarding payment.--
                    (A) In general.--Nothing in paragraph (1) 
                shall be construed to preclude a health 
                insurance issuer offering health insurance 
                coverage in the individual market from 
                obtaining and using the results of a genetic 
                test in making a determination regarding 
                payment (as such term is defined for the 
                purposes of applying the regulations 
                promulgated by the Secretary under part C of 
                title XI of the Social Security Act and section 
                264 of the Health Insurance Portability and 
                Accountability Act of 1996, as may be revised 
                from time to time) consistent with subsection 
                (a) and (c).
                    (B) Limitation.--For purposes of 
                subparagraph (A), a health insurance issuer 
                offering health insurance coverage in the 
                individual market may request only the minimum 
                amount of information necessary to accomplish 
                the intended purpose.
            (4) Research exception.--Notwithstanding paragraph 
        (1), a health insurance issuer offering health 
        insurance coverage in the individual market may 
        request, but not require, that an individual or a 
        family member of such individual undergo a genetic test 
        if each of the following conditions is met:
                    (A) The request is made pursuant to 
                research that complies with part 46 of title 
                45, Code of Federal Regulations, or equivalent 
                Federal regulations, and any applicable State 
                or local law or regulations for the protection 
                of human subjects in research.
                    (B) The issuer clearly indicates to each 
                individual, or in the case of a minor child, to 
                the legal guardian of such child, to whom the 
                request is made that--
                            (i) compliance with the request is 
                        voluntary; and
                            (ii) non-compliance will have no 
                        effect on enrollment status or premium 
                        or contribution amounts.
                    (C) No genetic information collected or 
                acquired under this paragraph shall be used for 
                underwriting purposes.
                    (D) The issuer notifies the Secretary in 
                writing that the issuer is conducting 
                activities pursuant to the exception provided 
                for under this paragraph, including a 
                description of the activities conducted.
                    (E) The issuer complies with such other 
                conditions as the Secretary may by regulation 
                require for activities conducted under this 
                paragraph.
    (e) Prohibition on Collection of Genetic Information.--
            (1) In general.--A health insurance issuer offering 
        health insurance coverage in the individual market 
        shall not request, require, or purchase genetic 
        information for underwriting purposes (as defined in 
        section 2791).
            (2) Prohibition on collection of genetic 
        information prior to enrollment.--A health insurance 
        issuer offering health insurance coverage in the 
        individual market shall not request, require, or 
        purchase genetic information with respect to any 
        individual prior to such individual's enrollment under 
        the plan in connection with such enrollment.
            (3) Incidental collection.--If a health insurance 
        issuer offering health insurance coverage in the 
        individual market obtains genetic information 
        incidental to the requesting, requiring, or purchasing 
        of other information concerning any individual, such 
        request, requirement, or purchase shall not be 
        considered a violation of paragraph (2) if such 
        request, requirement, or purchase is not in violation 
        of paragraph (1).
    (f) Genetic Information of a Fetus or Embryo.--Any 
reference in this part to genetic information concerning an 
individual or family member of an individual shall--
            (1) with respect to such an individual or family 
        member of an individual who is a pregnant woman, 
        include genetic information of any fetus carried by 
        such pregnant woman; and
            (2) with respect to an individual or family member 
        utilizing an assisted reproductive technology, include 
        genetic information of any embryo legally held by the 
        individual or family member.

                   Subpart 3--General Provisions \1\

SEC. 2761. [300GG-61] ENFORCEMENT.

    (a) State Enforcement.--
            (1) State authority.--Subject to section 2762, each 
        State may require that health insurance issuers that 
        issue, sell, renew, or offer health insurance coverage 
        in the State in the individual market meet the 
        requirements established under this part with respect 
        to such issuers.
---------------------------------------------------------------------------
    \1\ Section 605(a)(3) of Public Law 104-204 (110 Stat. 2941) adds 
this subpart designation and heading to part B.
---------------------------------------------------------------------------
            (2) Failure to implement requirements.--In the case 
        of a State that fails to substantially enforce the 
        requirements set forth in this part with respect to 
        health insurance issuers in the State, the Secretary 
        shall enforce the requirements of this part under 
        subsection (b) insofar as they relate to the issuance, 
        sale, renewal, and offering of health insurance 
        coverage in the individual market in such State.
    (b) Secretarial Enforcement Authority.--The Secretary shall 
have the same authority in relation to enforcement of the 
provisions of this part with respect to issuers of health 
insurance coverage in the individual market in a State as the 
Secretary has under section 2722(b)(2), and section 2722(b)(3) 
with respect to violations of genetic nondiscrimination 
provisions, in relation to the enforcement of the provisions of 
part A with respect to issuers of health insurance coverage in 
the small group market in the State.

SEC. 2762. [300GG-62] PREEMPTION. \1\
---------------------------------------------------------------------------

    \1\ Section 1563(c)(15)(A) (relating to conforming amendments--
originally designated as section 1562 and redesignated as section 1563 
by section 10107(b)(1)) of Public Law 111-148 provides for an amendment 
in the section heading by inserting ``AND APPLICATION'' before the 
period. Section 1563(c)(15)(B) (as so redesignated) of such Public Law 
provides for an amendment to add at the end a new subsection (c). See 
note set out in italic typeface that appears after subsection (b) 
below.

     The amendments to section 2762 made by section 1563(c)(15), as so 
redesignated, takes effect on date of enactment of Public Law 111-148 
(March 23, 2010); however, they're being treated here as if they take 
effect on January 1, 2014 to reflect the probable intent of Congress 
and in order to be consistent with the execution of different 
amendments made by such section 1563 to part A of this title (see 
details regarding the effective date in a note to a second version of 
part A).
---------------------------------------------------------------------------
    (a) In General.--Subject to subsection (b), nothing in this 
part (or part C insofar as it applies to this part) shall be 
construed to prevent a State from establishing, implementing, 
or continuing in effect standards and requirements unless such 
standards and requirements prevent the application of a 
requirement of this part.
    (b) Rules of Construction.--(1) Nothing in this part (or 
part C insofar as it applies to this part) shall be construed 
to affect or modify the provisions of section 514 of the 
Employee Retirement Income Security Act of 1974 (29 U.S.C. 
1144).
    (2) Nothing in this part (other than section 2751) shall be 
construed as requiring health insurance coverage offered in the 
individual market to provide specific benefits under the terms 
of such coverage.

======================================================================

    [Note: Section 1563(c)(15)(B) (relating to conforming 
amendments--originally designated as section 1562 and 
redesignated as section 1563 by section 10107(b)(1)) of Public 
Law 111-148 provides for an amendment to add a new subsection 
(c) at the end of section 2762. Such amendment takes effect on 
date of enactment of Public Law 111-148 (March 23, 2010); 
however, they're being treated here as if they take effect on 
January 1, 2014 to reflect the probable intent of Congress and 
in order to be consistent with the execution of different 
amendments made by such section 1563 to part A of this title 
(see details regarding the effective date in a note to a second 
version of part A). Upon such date, the following new 
subsection (c) reads as follows :]

    (c) Application of Part A Provisions.--
            (1) In general.--The provisions of part A shall 
        apply to health insurance issuers providing health 
        insurance coverage in the individual market in a State 
        as provided for in such part.
            (2) Clarification.--To the extent that any 
        provision of this part conflicts with a provision of 
        part A with respect to health insurance issuers 
        providing health insurance coverage in the individual 
        market in a State, the provisions of such part A shall 
        apply.

=======================================================================


SEC. 2763. [300GG-63] GENERAL EXCEPTIONS.

    (a) Exception for Certain Benefits.--The requirements of 
this part shall not apply to any health insurance coverage in 
relation to its provision of excepted benefits described in 
section 2791(c)(1).
    (b) Exception for Certain Benefits If Certain Conditions 
Met.--The requirements of this part shall not apply to any 
health insurance coverage in relation to its provision of 
excepted benefits described in paragraph (2), (3), or (4) of 
section 2791(c) if the benefits are provided under a separate 
policy, certificate, or contract of insurance.

SEC. 2753. [300GG-54] COVERAGE OF DEPENDENT STUDENTS ON MEDICALLY 
                    NECESSARY LEAVE OF ABSENCE. \1\
---------------------------------------------------------------------------

    \1\ The placement of section 2753 at the end of subpart 3 is so in 
law. See amendment made by section 2(b)(2) of Public Law 110-381 122 
Stat. 4084). Section 102(b)(1)(A) of Public Law 110-233 redesignated 
subpart 3 of part B as subpart 2. Also, another section designated as 
section 2753 was added by section 102(b)(1)(B) of such Public Law (122 
Stat. 893).
---------------------------------------------------------------------------
    The provisions of section 2707 shall apply to health 
insurance coverage offered by a health insurance issuer in the 
individual market in the same manner as they apply to health 
insurance coverage offered by a health insurance issuer in 
connection with a group health plan in the small or large group 
market.

             Part C--Definitions; Miscellaneous Provisions

SEC. 2791. [300GG-91] DEFINITIONS.

    (a) Group Health Plan.--
            (1) Definition.--The term ``group health plan'' 
        means an employee welfare benefit plan (as defined in 
        section 3(1) of the Employee Retirement Income Security 
        Act of 1974) to the extent that the plan provides 
        medical care (as defined in paragraph (2)) and 
        including items and services paid for as medical care) 
        to employees or their dependents (as defined under the 
        terms of the plan) directly or through insurance, 
        reimbursement, or otherwise.
            (2) Medical care.--The term ``medical care'' means 
        amounts paid for--
                    (A) the diagnosis, cure, mitigation, 
                treatment, or prevention of disease, or amounts 
                paid for the purpose of affecting any structure 
                or function of the body,
                    (B) amounts paid for transportation 
                primarily for and essential to medical care 
                referred to in subparagraph (A), and
                    (C) amounts paid for insurance covering 
                medical care referred to in subparagraphs (A) 
                and (B).
            (3) Treatment of certain plans as group health plan 
        for notice provision.--A program under which creditable 
        coverage described in subparagraph (C), (D), (E), or 
        (F) of section 2701(c)(1) is provided shall be treated 
        as a group health plan for purposes of applying section 
        2701(e).
    (b) Definitions Relating to Health Insurance.--
            (1) Health insurance coverage.--The term ``health 
        insurance coverage'' means benefits consisting of 
        medical care (provided directly, through insurance or 
        reimbursement, or otherwise and including items and 
        services paid for as medical care) under any hospital 
        or medical service policy or certificate, hospital or 
        medical service plan contract, or health maintenance 
        organization contract offered by a health insurance 
        issuer.
            (2) Health insurance issuer.--The term ``health 
        insurance issuer'' means an insurance company, 
        insurance service, or insurance organization (including 
        a health maintenance organization, as defined in 
        paragraph (3)) which is licensed to engage in the 
        business of insurance in a State and which is subject 
        to State law which regulates insurance (within the 
        meaning of section 514(b)(2) of the Employee Retirement 
        Income Security Act of 1974). Such term does not 
        include a group health plan.
            (3) Health maintenance organization.--The term 
        ``health maintenance organization'' means--
                    (A) a Federally qualified health 
                maintenance organization (as defined in section 
                1301(a)),
                    (B) an organization recognized under State 
                law as a health maintenance organization, or
                    (C) a similar organization regulated under 
                State law for solvency in the same manner and 
                to the same extent as such a health maintenance 
                organization.
            (4) Group health insurance coverage.--The term 
        ``group health insurance coverage'' means, in 
        connection with a group health plan, health insurance 
        coverage offered in connection with such plan.
            (5) Individual health insurance coverage.--The term 
        ``individual health insurance coverage'' means health 
        insurance coverage offered to individuals in the 
        individual market, but does not include short-term 
        limited duration insurance.
    (c) Excepted Benefits.--For purposes of this title, the 
term ``excepted benefits'' means benefits under one or more (or 
any combination thereof) of the following:
            (1) Benefits not subject to requirements.--
                    (A) Coverage only for accident, or 
                disability income insurance, or any combination 
                thereof.
                    (B) Coverage issued as a supplement to 
                liability 
                insurance.
                    (C) Liability insurance, including general 
                liability insurance and automobile liability 
                insurance.
                    (D) Workers' compensation or similar 
                insurance.
                    (E) Automobile medical payment insurance.
                    (F) Credit-only insurance.
                    (G) Coverage for on-site medical clinics.
                    (H) Other similar insurance coverage, 
                specified in regulations, under which benefits 
                for medical care are secondary or incidental to 
                other insurance benefits.
            (2) Benefits not subject to requirements if offered 
        separately.--
                    (A) Limited scope dental or vision 
                benefits.
                    (B) Benefits for long-term care, nursing 
                home care, home health care, community-based 
                care, or any combination thereof.
                    (C) Such other similar, limited benefits as 
                are specified in regulations.
            (3) Benefits not subject to requirements if offered 
        as independent, noncoordinated benefits.--
                    (A) Coverage only for a specified disease 
                or illness.
                    (B) Hospital indemnity or other fixed 
                indemnity insurance.
            (4) Benefits not subject to requirements if offered 
        as separate insurance policy.--Medicare supplemental 
        health insurance (as defined under section 1882(g)(1) 
        of the Social Security Act), coverage supplemental to 
        the coverage provided under chapter 55 of title 10, 
        United States Code, and similar supplemental coverage 
        provided to coverage under a group health plan.
    (d) \1\ Other Definitions.--
---------------------------------------------------------------------------
    \1\ For version of law for section 2791(d)(20)-(21) (as amended by 
section 1563(b) (relating to conforming amendments--originally 
designated as section 1562 and redesignated as section 1563 by section 
10107(b)(1)) of Public Law 111-148) see note set out in italic typeface 
that appears after paragraph (19).
---------------------------------------------------------------------------
            (1) Applicable state authority.--The term 
        ``applicable State authority'' means, with respect to a 
        health insurance issuer in a State, the State insurance 
        commissioner or official or officials designated by the 
        State to enforce the requirements of this title for the 
        State involved with respect to such issuer.
            (2) Beneficiary.--The term ``beneficiary'' has the 
        meaning given such term under section 3(8) of the 
        Employee Retirement Income Security Act of 1974.
            (3) Bona fide association.--The term ``bona fide 
        association'' means, with respect to health insurance 
        coverage offered in a State, an association which--
                    (A) has been actively in existence for at 
                least 5 years;
                    (B) has been formed and maintained in good 
                faith for purposes other than obtaining 
                insurance;
                    (C) does not condition membership in the 
                association on any health status-related factor 
                relating to an individual (including an 
                employee of an employer or a dependent of an 
                employee);
                    (D) makes health insurance coverage offered 
                through the association available to all 
                members regardless of any health status-related 
                factor relating to such members (or individuals 
                eligible for coverage through a member);
                    (E) does not make health insurance coverage 
                offered through the association available other 
                than in connection with a member of the 
                association; and
                    (F) meets such additional requirements as 
                may be imposed under State law.
            (4) COBRA continuation provision.--The term ``COBRA 
        continuation provision'' means any of the following:
                    (A) Section 4980B of the Internal Revenue 
                Code of 1986, other than subsection (f)(1) of 
                such section insofar as it relates to pediatric 
                vaccines.
                    (B) Part 6 of subtitle B of title I of the 
                Employee Retirement Income Security Act of 
                1974, other than section 609 of such Act.
                    (C) Title XXII of this Act.
            (5) Employee.--The term ``employee'' has the 
        meaning given such term under section 3(6) of the 
        Employee Retirement Income Security Act of 1974.
            (6) Employer.--The term ``employer'' has the 
        meaning given such term under section 3(5) of the 
        Employee Retirement Income Security Act of 1974, except 
        that such term shall include only employers of two or 
        more employees.
            (7) Church plan.--The term ``church plan'' has the 
        meaning given such term under section 3(33) of the 
        Employee Retirement Income Security Act of 1974.
            (8) Governmental plan.--(A) The term ``governmental 
        plan'' has the meaning given such term under section 
        3(32) of the Employee Retirement Income Security Act of 
        1974 and any Federal governmental plan.
            (B) Federal governmental plan.--The term ``Federal 
        governmental plan'' means a governmental plan 
        established or maintained for its employees by the 
        Government of the United States or by any agency or 
        instrumentality of such Government.
            (C) Non-Federal governmental plan.--The term ``non-
        Federal governmental plan'' means a governmental plan 
        that is not a Federal governmental plan.
            (9) Health status-related factor.--The term 
        ``health status-related factor'' means any of the 
        factors described in section 2702(a)(1).
            (10) Network plan.--The term ``network plan'' means 
        health insurance coverage of a health insurance issuer 
        under which the financing and delivery of medical care 
        (including items and services paid for as medical care) 
        are provided, in whole or in part, through a defined 
        set of providers under contract with the issuer.
            (11) Participant.--The term ``participant'' has the 
        meaning given such term under section 3(7) of the 
        Employee Retirement Income Security Act of 1974.
            (12) Placed for adoption defined.--The term 
        ``placement'', or being ``placed'', for adoption, in 
        connection with any placement for adoption of a child 
        with any person, means the assumption and retention by 
        such person of a legal obligation for total or partial 
        support of such child in anticipation of adoption of 
        such child. The child's placement with such person 
        terminates upon the termination of such legal 
        obligation.
            (13) Plan sponsor.--The term ``plan sponsor'' has 
        the meaning given such term under section 3(16)(B) of 
        the Employee Retirement Income Security Act of 1974.
            (14) State.--The term ``State'' means each of the 
        several States, the District of Columbia, Puerto Rico, 
        the Virgin Islands, Guam, American Samoa, and the 
        Northern Mariana Islands.
            (15) Family member.--The term ``family member'' 
        means, with respect to any individual--
                    (A) a dependent (as such term is used for 
                purposes of section 2701(f)(2)) of such 
                individual; and
                    (B) any other individual who is a first-
                degree, second-degree, third-degree, or fourth-
                degree relative of such individual or of an 
                individual described in subparagraph (A).
            (16) Genetic information.--
                    (A) In general.--The term ``genetic 
                information'' means, with respect to any 
                individual, information about--
                            (i) such individual's genetic 
                        tests,
                            (ii) the genetic tests of family 
                        members of such individual, and
                            (iii) the manifestation of a 
                        disease or disorder in family members 
                        of such individual.
                    (B) Inclusion of genetic services and 
                participation in genetic research.--Such term 
                includes, with respect to any individual, any 
                request for, or receipt of, genetic services, 
                or participation in clinical research which 
                includes genetic services, by such individual 
                or any family member of such individual.
                    (C) Exclusions.--The term ``genetic 
                information'' shall not include information 
                about the sex or age of any individual.
            (17) Genetic test.--
                    (A) In general.--The term ``genetic test'' 
                means an analysis of human DNA, RNA, 
                chromosomes, proteins, or metabolites, that 
                detects genotypes, mutations, or chromosomal 
                changes.
                    (B) Exceptions.--The term ``genetic test'' 
                does not mean--
                            (i) an analysis of proteins or 
                        metabolites that does not detect 
                        genotypes, mutations, or chromosomal 
                        changes; or
                            (ii) an analysis of proteins or 
                        metabolites that is directly related to 
                        a manifested disease, disorder, or 
                        pathological condition that could 
                        reasonably be detected by a health care 
                        professional with appropriate training 
                        and expertise in the field of medicine 
                        involved.
            (18) Genetic services.--The term ``genetic 
        services'' means--
                    (A) a genetic test;
                    (B) genetic counseling (including 
                obtaining, interpreting, or assessing genetic 
                information); or
                    (C) genetic education.
            (19) Underwriting purposes.--The term 
        ``underwriting purposes'' means, with respect to any 
        group health plan, or health insurance coverage offered 
        in connection with a group health plan--
                    (A) rules for, or determination of, 
                eligibility (including enrollment and continued 
                eligibility) for benefits under the plan or 
                coverage;
                    (B) the computation of premium or 
                contribution amounts under the plan or 
                coverage;
                    (C) the application of any pre-existing 
                condition exclusion under the plan or coverage; 
                and
                    (D) other activities related to the 
                creation, renewal, or replacement of a contract 
                of health insurance or health benefits.

=======================================================================

    [Note: Section 1563(b) (relating to conforming amendments--
originally designated as section 1562 and redesignated as 
section 1563 by section 10107(b)(1)) of Public Law 111-148 
provides for an amendment to add new paragraphs (20)-(21) at 
the end of section 2791(d). Such amendment takes effect on date 
of enactment of Public Law 111-148 (March 23, 2010); however, 
they're being treated here as if they take effect on January 1, 
2014 to reflect the probable intent of Congress and in order to 
be consistent with the execution of different amendments made 
by such section 1563 to part A of this title (see details 
regarding the effective date in a note to a second version of 
part A). Upon such date, paragraphs (20)-(21) read as follows:]

            (20) Qualified health plan.--The term ``qualified 
        health plan'' has the meaning given such term in 
        section 1301(a) of the Patient Protection and 
        Affordable Care Act.
            (21) Exchange.--The term ``Exchange'' means an 
        American Health Benefit Exchange established under 
        section 1311 of the Patient Protection and Affordable 
        Care Act.

=======================================================================


    (e) Definitions Relating to Markets and Small Em-
ployers.--For purposes of this title:
            (1) Individual market.--
                    (A) In general.--The term ``individual 
                market'' means the market for health insurance 
                coverage offered to individuals other than in 
                connection with a group health plan.
                    (B) Treatment of very small groups.--
                            (i) In general.--Subject to clause 
                        (ii), such terms includes coverage 
                        offered in connection with a group 
                        health plan that has fewer than two 
                        participants as current employees on 
                        the first day of the plan year.
                            (ii) State exception.--Clause (i) 
                        shall not apply in the case of a State 
                        that elects to regulate the coverage 
                        described in such clause as coverage in 
                        the small group market.
            (2) Large employer.--The term ``large employer'' 
        means, in connection with a group health plan with 
        respect to a calendar year and a plan year, an employer 
        who employed an average of at least 51 \1\ employees on 
        business days during the preceding calendar year and 
        who employs at least 2 employees on the first day of 
        the plan year.
---------------------------------------------------------------------------
    \1\ Section 1563(c)(16)(A) (relating to conforming amendments--
originally designated as section 1562 and redesignated as section 1563 
by section 10107(b)(1)) of Public Law 111-148 provides for an amendment 
to section 2791(e)(2) by striking ``51'' and inserting ``101''.

     The amendment to section 2791(e) made by section 1563(c)(16)(A), 
as so redesignated, takes effect on date of enactment of Public Law 
111-148 (March 23, 2010); however, they're being treated here as if 
they take effect on January 1, 2014 to reflect the probable intent of 
Congress and in order to be consistent with the execution of different 
amendments made by such section 1563 to part A of this title (see 
details regarding the effective date in a note to a second version of 
part A).
---------------------------------------------------------------------------
            (3) Large group market.--The term ``large group 
        market'' means the health insurance market under which 
        individuals obtain health insurance coverage (directly 
        or through any arrangement) on behalf of themselves 
        (and their dependents) through a group health plan 
        maintained by a large employer.
            (4) \2\ Small employer.--The term ``small 
        employer'' means, in connection with a group health 
        plan with respect to a calendar year and a plan year, 
        an employer who employed an average of at least 2 but 
        not more than 50 employees on business days during the 
        preceding calendar year and who employs at least 2 
        employees on the first day of the plan year.
---------------------------------------------------------------------------
    \2\ For version of law of paragraph (4) (as amended by section 
1563(c)(16)(B) (relating to conforming amendments--originally 
designated as section 1562 and redesignated as section 1563 by section 
10107(b)(1)) of Public Law 111-148) see note set out in italic typeface 
that appears after this paragraph.

---------------------------------------------------------------------------
=======================================================================


    [Note: Section 1563(c)(16)(B) (relating to conforming 
amendments--originally designated as section 1562 and 
redesignated as section 1563 by section 10107(b)(1)) of Public 
Law 111-148 provides for amendments to paragraph (4) of section 
2791(e). Such amendments take effect on date of enactment of 
Public Law 111-148 (March 23, 2010); however, they're being 
treated here as if they take effect on January 1, 2014 to 
reflect the probable intent of Congress and in order to be 
consistent with the execution of different amendments made by 
such section 1563 to part A of this title (see details 
regarding the effective date in a note to a second version of 
part A). Upon such date, paragraph (4) reads as follows:]

            (4) Small employer.--The term ``small employer'' 
        means, in connection with a group health plan with 
        respect to a calendar year and a plan year, an employer 
        who employed an average of at least 1 but not more than 
        100 employees on business days during the preceding 
        calendar year and who employs at least 1 employees on 
        the first day of the plan year.

=======================================================================


            (5) Small group market.--The term ``small group 
        market'' means the health insurance market under which 
        individuals obtain health insurance coverage (directly 
        or through any arrangement) on behalf of themselves 
        (and their dependents) through a group health plan 
        maintained by a small employer.
            (6) Application of certain rules in determination 
        of employer size.--For purposes of this subsection--
                    (A) Application of aggregation rule for 
                employers.--all persons treated as a single 
                employer under subsection (b), (c), (m), or (o) 
                of section 414 of the Internal Revenue Code of 
                1986 shall be treated as 1 employer.
                    (B) Employers not in existence in preceding 
                year.--In the case of an employer which was not 
                in existence throughout the preceding calendar 
                year, the determination of whether such 
                employer is a small or large employer shall be 
                based on the average number of employees that 
                it is reasonably expected such employer will 
                employ on business days in the current calendar 
                year.
                    (C) Predecessors.--Any reference in this 
                subsection to an employer shall include a 
                reference to any predecessor of such employer.

SEC. 2792. [300GG-92] REGULATIONS.

    The Secretary, consistent with section 104 of the Health 
Care Portability and Accountability Act of 1996, may promulgate 
such regulations as may be necessary or appropriate to carry 
out the provisions of this title. The Secretary may promulgate 
any interim final rules as the Secretary determines are 
appropriate to carry out this title.

SEC. 2793. [300GG-93] HEALTH INSURANCE CONSUMER INFORMATION.

    (a) In General.--The Secretary shall award grants to States 
to enable such States (or the Exchanges operating in such 
States) to establish, expand, or provide support for--
            (1) offices of health insurance consumer 
        assistance; or
            (2) health insurance ombudsman programs.
    (b) Eligibility.--
            (1) In general.--To be eligible to receive a grant, 
        a State shall designate an independent office of health 
        insurance consumer assistance, or an ombudsman, that, 
        directly or in coordination with State health insurance 
        regulators and consumer assistance organizations, 
        receives and responds to inquiries and complaints 
        concerning health insurance coverage with respect to 
        Federal health insurance requirements and under State 
        law.
            (2) Criteria.--A State that receives a grant under 
        this section shall comply with criteria established by 
        the Secretary for carrying out activities under such 
        grant.
    (c) Duties.--The office of health insurance consumer 
assistance or health insurance ombudsman shall--
            (1) assist with the filing of complaints and 
        appeals, including filing appeals with the internal 
        appeal or grievance process of the group health plan or 
        health insurance issuer involved and providing 
        information about the external appeal process;
            (2) collect, track, and quantify problems and 
        inquiries encountered by consumers;
            (3) educate consumers on their rights and 
        responsibilities with respect to group health plans and 
        health insurance coverage;
            (4) assist consumers with enrollment in a group 
        health plan or health insurance coverage by providing 
        information, referral, and assistance; and
            (5) resolve problems with obtaining premium tax 
        credits under section 36B of the Internal Revenue Code 
        of 1986.
    (d) Data Collection.--As a condition of receiving a grant 
under subsection (a), an office of health insurance consumer 
assistance or ombudsman program shall be required to collect 
and report data to the Secretary on the types of problems and 
inquiries encountered by consumers. The Secretary shall utilize 
such data to identify areas where more enforcement action is 
necessary and shall share such information with State insurance 
regulators, the Secretary of Labor, and the Secretary of the 
Treasury for use in the enforcement activities of such 
agencies.
    (e) Funding.--
            (1) Initial funding.--There is hereby appropriated 
        to the Secretary, out of any funds in the Treasury not 
        otherwise appropriated, $30,000,000 for the first 
        fiscal year for which this section applies to carry out 
        this section. Such amount shall remain available 
        without fiscal year limitation.
            (2) Authorization for subsequent years.--There is 
        authorized to be appropriated to the Secretary for each 
        fiscal year following the fiscal year described in 
        paragraph (1), such sums as may be necessary to carry 
        out this section.

SEC. 2794. [300GG-94] ENSURING THAT CONSUMERS GET VALUE FOR THEIR 
                    DOLLARS.

    (a) Initial Premium Review Process.--
            (1) In general.--The Secretary, in conjunction with 
        States, shall establish a process for the annual 
        review, beginning with the 2010 plan year and subject 
        to subsection (b)(2)(A), of unreasonable increases in 
        premiums for health insurance coverage.
            (2) Justification and disclosure.--The process 
        established under paragraph (1) shall require health 
        insurance issuers to submit to the Secretary and the 
        relevant State a justification for an unreasonable 
        premium increase prior to the implementation of the 
        increase. Such issuers shall prominently post such 
        information on their Internet websites. The Secretary 
        shall ensure the public disclosure of information on 
        such increases and justifications for all health 
        insurance issuers.
    (b) Continuing Premium Review Process.--
            (1) Informing secretary of premium increase 
        patterns.--As a condition of receiving a grant under 
        subsection (c)(1), a State, through its Commissioner of 
        Insurance, shall--
                    (A) provide the Secretary with information 
                about trends in premium increases in health 
                insurance coverage in premium rating areas in 
                the State; and
                    (B) make recommendations, as appropriate, 
                to the State Exchange about whether particular 
                health insurance issuers should be excluded 
                from participation in the Exchange based on a 
                pattern or practice of excessive or unjustified 
                premium increases.
            (2) Monitoring by secretary of premium increases.--
                    (A) In general.--Beginning with plan years 
                beginning in 2014, the Secretary, in 
                conjunction with the States and consistent with 
                the provisions of subsection (a)(2), shall 
                monitor premium increases of health insurance 
                coverage offered through an Exchange and 
                outside of an Exchange.
                    (B) Consideration in opening exchange.--In 
                determining under section 1312(f)(2)(B) of the 
                Patient Protection and Affordable Care Act 
                whether to offer qualified health plans in the 
                large group market through an Exchange, the 
                State shall take into account any excess of 
                premium growth outside of the Exchange as 
                compared to the rate of such growth inside the 
                Exchange.
    (c) Grants in Support of Process.--
            (1) Premium review grants during 2010 through 
        2014.--The Secretary shall carry out a program to award 
        grants to States during the 5-year period beginning 
        with fiscal year 2010 to assist such States in carrying 
        out subsection (a), including--
                    (A) in reviewing and, if appropriate under 
                State law, approving premium increases for 
                health insurance coverage;
                    (B) in providing information and 
                recommendations to the Secretary under 
                subsection (b)(1); and
                    (C) in establishing centers (consistent 
                with subsection (d)) at academic or other 
                nonprofit institutions to collect medical 
                reimbursement information from health insurance 
                issuers, to analyze and organize such 
                information, and to make such information 
                available to such issuers, health care 
                providers, health researchers, health care 
                policy makers, and the general public.
            (2) Funding.--
                    (A) In general.--Out of all funds in the 
                Treasury not otherwise appropriated, there are 
                appropriated to the Secretary $250,000,000, to 
                be available for expenditure for grants under 
                paragraph (1) and subparagraph (B).
                    (B) Further availability for insurance 
                reform and consumer protection.--If the amounts 
                appropriated under subparagraph (A) are not 
                fully obligated under grants under paragraph 
                (1) by the end of fiscal year 2014, any 
                remaining funds shall remain available to the 
                Secretary for grants to States for planning and 
                implementing the insurance reforms and consumer 
                protections under part A.
                    (C) Allocation.--The Secretary shall 
                establish a formula for determining the amount 
                of any grant to a State under this subsection. 
                Under such formula--
                            (i) the Secretary shall consider 
                        the number of plans of health insurance 
                        coverage offered in each State and the 
                        population of the State; and
                            (ii) no State qualifying for a 
                        grant under paragraph (1) shall receive 
                        less than $1,000,000, or more than 
                        $5,000,000 for a grant year.
    (d) Medical Reimbursement Data Centers.--
            (1) Functions.--A center established under 
        subsection (c)(1)(C) shall--
                    (A) develop fee schedules and other 
                database tools that fairly and accurately 
                reflect market rates for medical services and 
                the geographic differences in those rates;
                    (B) use the best available statistical 
                methods and data processing technology to 
                develop such fee schedules and other database 
                tools;
                    (C) regularly update such fee schedules and 
                other database tools to reflect changes in 
                charges for medical services;
                    (D) make health care cost information 
                readily available to the public through an 
                Internet website that allows consumers to 
                understand the amounts that health care 
                providers in their area charge for particular 
                medical services; and
                    (E) regularly publish information 
                concerning the statistical methodologies used 
                by the center to analyze health charge data and 
                make such data available to researchers and 
                policy makers.
            (2) Conflicts of interest.--A center established 
        under subsection (c)(1)(C) shall adopt by-laws that 
        ensures that the center (and all members of the 
        governing board of the center) is independent and free 
        from all conflicts of interest. Such by-laws shall 
        ensure that the center is not controlled or influenced 
        by, and does not have any corporate relation to, any 
        individual or entity that may make or receive payments 
        for health care services based on the center's analysis 
        of health care costs.
            (3) Rule of construction.--Nothing in this 
        subsection shall be construed to permit a center 
        established under subsection (c)(1)(C) to compel health 
        insurance issuers to provide data to the center.

SEC. 2794. [300GG-95] UNIFORM FRAUD AND ABUSE REFERRAL FORMAT. \1\
---------------------------------------------------------------------------

    \1\ So in law. There are two sections 2794s'. Sections 1003 and 
6603 of Public Law 111-148 add new section 2794s' to the end of part C 
of title XXVII.
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    The Secretary shall request the National Association of 
Insurance Commissioners to develop a model uniform report form 
for private health insurance issuer seeking to refer suspected 
fraud and abuse to State insurance departments or other 
responsible State agencies for investigation. The Secretary 
shall request that the National Association of Insurance 
Commissioners develop recommendations for uniform reporting 
standards for such referrals.ATTORNEY: PMG/VLC (July 
10, 2002) deg.
   TITLE XXVIII--NATIONAL ALL-HAZARDS PREPAREDNESS FOR PUBLIC HEALTH 
                              EMERGENCIES

 Subtitle A--National All-Hazards Preparedness and Response Planning, 
                      Coordinating, and Reporting

SEC. 2801. [300HH] PUBLIC HEALTH AND MEDICAL PREPAREDNESS AND RESPONSE 
                    FUNCTIONS.

    (a) In General.--The Secretary of Health and Human Services 
shall lead all Federal public health and medical response to 
public health emergencies and incidents covered by the National 
Response Plan developed pursuant to section 502(6) of the 
Homeland Security Act of 2002, or any successor plan.
    (b) Interagency Agreement.--The Secretary, in collaboration 
with the Secretary of Veterans Affairs, the Secretary of 
Transportation, the Secretary of Defense, the Secretary of 
Homeland Security, and the head of any other relevant Federal 
agency, shall establish an interagency agreement, consistent 
with the National Response Plan or any successor plan, under 
which agreement the Secretary of Health and Human Services 
shall assume operational control of emergency public health and 
medical response assets, as necessary, in the event of a public 
health emergency, except that members of the armed forces under 
the authority of the Secretary of Defense shall remain under 
the command and control of the Secretary of Defense, as shall 
any associated assets of the Department of Defense.

SEC. 2802. [300HH-1] NATIONAL HEALTH SECURITY STRATEGY.

    (a) In General.--
            (1) Preparedness and response regarding public 
        health emergencies.--Beginning in 2009 and every four 
        years thereafter, the Secretary shall prepare and 
        submit to the relevant committees of Congress a 
        coordinated strategy (to be known as the National 
        Health Security Strategy) and any revisions thereof, 
        and an accompanying implementation plan for public 
        health emergency preparedness and response. Such 
        National Health Security Strategy shall identify the 
        process for achieving the preparedness goals described 
        in subsection (b) and shall be consistent with the 
        National Preparedness Goal, the National Incident 
        Management System, and the National Response Plan 
        developed pursuant to section 502(6) of the Homeland 
        Security Act of 2002, or any successor plan.
            (2) Evaluation of progress.--The National Health 
        Security Strategy shall include an evaluation of the 
        progress made by Federal, State, local, and tribal 
        entities, based on the evidence-based benchmarks and 
        objective standards that measure levels of preparedness 
        established pursuant to section 319C-1(g). Such 
        evaluation shall include aggregate and State-specific 
        breakdowns of obligated funding spent by major category 
        (as defined by the Secretary) for activities funded 
        through awards pursuant to sections 319C-1 and 319C-2.
            (3) Public health workforce.--In 2009, the National 
        Health Security Strategy shall include a national 
        strategy for establishing an effective and prepared 
        public health workforce, including defining the 
        functions, capabilities, and gaps in such workforce, 
        and identifying strategies to recruit, retain, and 
        protect such workforce from workplace exposures during 
        public health emergencies.
    (b) Preparedness Goals.--The National Health Security 
Strategy shall include provisions in furtherance of the 
following:
            (1) Integration.--Integrating public health and 
        public and private medical capabilities with other 
        first responder systems, including through--
                    (A) the periodic evaluation of Federal, 
                State, local, and tribal preparedness and 
                response capabilities through drills and 
                exercises; and
                    (B) integrating public and private sector 
                public health and medical donations and 
                volunteers.
            (2) Public health.--Developing and sustaining 
        Federal, State, local, and tribal essential public 
        health security capabilities, including the following:
                    (A) Disease situational awareness 
                domestically and abroad, including detection, 
                identification, and investigation.
                    (B) Disease containment including 
                capabilities for isolation, quarantine, social 
                distancing, and decontamination.
                    (C) Risk communication and public 
                preparedness.
                    (D) Rapid distribution and administration 
                of medical countermeasures.
            (3) Medical.--Increasing the preparedness, response 
        capabilities, and surge capacity of hospitals, other 
        health care facilities (including mental health 
        facilities), and trauma care and emergency medical 
        service systems, with respect to public health 
        emergencies, which shall include developing plans for 
        the following:
                    (A) Strengthening public health emergency 
                medical management and treatment capabilities.
                    (B) Medical evacuation and fatality 
                management.
                    (C) Rapid distribution and administration 
                of medical countermeasures.
                    (D) Effective utilization of any available 
                public and private mobile medical assets and 
                integration of other Federal assets.
                    (E) Protecting health care workers and 
                health care first responders from workplace 
                exposures during a public health emergency.
            (4) At-risk individuals.--
                    (A) Taking into account the public health 
                and medical needs of at-risk individuals in the 
                event of a public health emergency.
                    (B) For purpose of this section and 
                sections 319C-1, 319F, and 319L, the term ``at-
                risk individuals'' means children, pregnant 
                women, senior citizens and other individuals 
                who have special needs in the event of a public 
                health emergency, as determined by the 
                Secretary.
            (5) Coordination.--Minimizing duplication of, and 
        ensuring coordination between, Federal, State, local, 
        and tribal planning, preparedness, and response 
        activities (including the State Emergency Management 
        Assistance Compact). Such planning shall be consistent 
        with the National Response Plan, or any successor plan, 
        and National Incident Management System and the 
        National Preparedness Goal.
            (6) Continuity of operations.--Maintaining vital 
        public health and medical services to allow for optimal 
        Federal, State, local, and tribal operations in the 
        event of a public health emergency.

SEC. 2803. [300HH-2] ENHANCING MEDICAL SURGE CAPACITY.

    (a) Study of Enhancing Medical Surge Capacity.--As part of 
the joint review described in section 2812(b), the Secretary 
shall evaluate the benefits and feasibility of improving the 
capacity of the Department of Health and Human Services to 
provide additional medical surge capacity to local communities 
in the event of a public health emergency. Such study shall 
include an assessment of the need for and feasibility of 
improving surge capacity through--
            (1) acquisition and operation of mobile medical 
        assets by the Secretary to be deployed, on a 
        contingency basis, to a community in the event of a 
        public health emergency;
            (2) integrating the practice of telemedicine within 
        the National Disaster Medical System; and
            (3) other strategies to improve such capacity as 
        determined appropriate by the Secretary.
    (b) Authority To Acquire and Operate Mobile Medical 
Assets.--In addition to any other authority to acquire, deploy, 
and operate mobile medical assets, the Secretary may acquire, 
deploy, and operate mobile medical assets if, taking into 
consideration the evaluation conducted under subsection (a), 
such acquisition, deployment, and operation is determined to be 
beneficial and feasible in improving the capacity of the 
Department of Health and Human Services to provide additional 
medical surge capacity to local communities in the event of a 
public health emergency.
    (c) Using Federal Facilities To Enhance Medical Surge 
Capacity.--
            (1) Analysis.--The Secretary shall conduct an 
        analysis of whether there are Federal facilities which, 
        in the event of a public health emergency, could 
        practicably be used as facilities in which to provide 
        health care.
            (2) Memoranda of understanding.--If, based on the 
        analysis conducted under paragraph (1), the Secretary 
        determines that there are Federal facilities which, in 
        the event of a public health emergency, could be used 
        as facilities in which to provide health care, the 
        Secretary shall, with respect to each such facility, 
        seek to conclude a memorandum of understanding with the 
        head of the Department or agency that operates such 
        facility that permits the use of such facility to 
        provide health care in the event of a public health 
        emergency.

      Subtitle B--All-Hazards Emergency Preparedness and Response

SEC. 2811. [300HH-10] COORDINATION OF PREPAREDNESS FOR AND RESPONSE TO 
                    ALL-HAZARDS PUBLIC HEALTH EMERGENCIES.

    (a) In General.--There is established within the Department 
of Health and Human Services the position of the Assistant 
Secretary for Preparedness and Response. The President, with 
the advice and consent of the Senate, shall appoint an 
individual to serve in such position. Such Assistant Secretary 
shall report to the Secretary.
    (b) Duties.--Subject to the authority of the Secretary, the 
Assistant Secretary for Preparedness and Response shall carry 
out the following functions:
            (1) Leadership.--Serve as the principal advisor to 
        the Secretary on all matters related to Federal public 
        health and medical preparedness and response for public 
        health emergencies.
            (2) Personnel.--Register, credential, organize, 
        train, equip, and have the authority to deploy Federal 
        public health and medical personnel under the authority 
        of the Secretary, including the National Disaster 
        Medical System, and coordinate such personnel with the 
        Medical Reserve Corps and the Emergency System for 
        Advance Registration of Volunteer Health Professionals.
            (3) Countermeasures.--Oversee advanced research, 
        development, and procurement of qualified 
        countermeasures (as defined in section 319F-1) and 
        qualified pandemic or epidemic products (as defined in 
        section 319F-3).
            (4) Coordination.--
                    (A) Federal integration.--Coordinate with 
                relevant Federal officials to ensure 
                integration of Federal preparedness and 
                response activities for public health 
                emergencies.
                    (B) State, local, and tribal integration.--
                Coordinate with State, local, and tribal public 
                health officials, the Emergency Management 
                Assistance Compact, health care systems, and 
                emergency medical service systems to ensure 
                effective integration of Federal public health 
                and medical assets during a public health 
                emergency.
                    (C) Emergency medical services.--Promote 
                improved emergency medical services medical 
                direction, system integration, research, and 
                uniformity of data collection, treatment 
                protocols, and policies with regard to public 
                health emergencies.
            (5) Logistics.--In coordination with the Secretary 
        of Veterans Affairs, the Secretary of Homeland 
        Security, the General Services Administration, and 
        other public and private entities, provide logistical 
        support for medical and public health aspects of 
        Federal responses to public health emergencies.
            (6) Leadership.--Provide leadership in 
        international programs, initiatives, and policies that 
        deal with public health and medical emergency 
        preparedness and response.
    (c) Functions.--The Assistant Secretary for Preparedness 
and Response shall--
            (1) have authority over and responsibility for--
                    (A) the National Disaster Medical System 
                (in accordance with section 301 of the Pandemic 
                and All-Hazards Preparedness Act); and
                    (B) the Hospital Preparedness Cooperative 
                Agreement Program pursuant to section 319C-2;
            (2) exercise the responsibilities and authorities 
        of the Secretary with respect to the coordination of--
                    (A) the Medical Reserve Corps pursuant to 
                section 2813;
                    (B) the Emergency System for Advance 
                Registration of Volunteer Health Professionals 
                pursuant to section 319I;
                    (C) the Strategic National Stockpile; and
                    (D) the Cities Readiness Initiative; and
            (3) assume other duties as determined appropriate 
        by the Secretary.

SEC. 2812. [300HH-11] NATIONAL DISASTER MEDICAL SYSTEM.

    (a) National Disaster Medical System.--
            (1) In general.--The Secretary shall provide for 
        the operation in accordance with this section of a 
        system to be known as the National Disaster Medical 
        System. The Secretary shall designate the Assistant 
        Secretary for Preparedness and Response as the head of 
        the National Disaster Medical System, subject to the 
        authority of the Secretary.
            (2) Federal and state collaborative system.--
                    (A) In general.--The National Disaster 
                Medical System shall be a coordinated effort by 
                the Federal agencies specified in subparagraph 
                (B), working in collaboration with the States 
                and other appropriate public or private 
                entities, to carry out the purposes described 
                in paragraph (3).
                    (B) Participating federal agencies.--The 
                Federal agencies referred to in subparagraph 
                (A) are the Department of Health and Human 
                Services, the Department of Homeland Security, 
                the Department of Defense, and the Department 
                of Veterans Affairs.
            (3) Purpose of system.--
                    (A) In general.--The Secretary may activate 
                the National Disaster Medical System to--
                            (i) provide health services, 
                        health-related social services, other 
                        appropriate human services, and 
                        appropriate auxiliary services to 
                        respond to the needs of victims of a 
                        public health emergency (whether or not 
                        determined to be a public health 
                        emergency under section 319); or
                            (ii) be present at locations, and 
                        for limited periods of time, specified 
                        by the Secretary on the basis that the 
                        Secretary has determined that a 
                        location is at risk of a public health 
                        emergency during the time specified.
                    (B) Ongoing activities.--The National 
                Disaster Medical System shall carry out such 
                ongoing activities as may be necessary to 
                prepare for the provision of services described 
                in subparagraph (A) in the event that the 
                Secretary activates the National Disaster 
                Medical System for such purposes.
                    (C) Test for mobilization of system.--
                During the one-year period beginning on the 
                date of the enactment of the Pandemic and All-
                Hazards Preparedness Act, the Secretary shall 
                conduct an exercise to test the capability and 
                timeliness of the National Disaster Medical 
                System to mobilize and otherwise respond 
                effectively to a bioterrorist attack or other 
                public health emergency that affects two or 
                more geographic locations concurrently. 
                Thereafter, the Secretary may periodically 
                conduct such exercises regarding the National 
                Disaster Medical System as the Secretary 
                determines to be appropriate.
    (b) Modifications.--
            (1) In general.--Taking into account the findings 
        from the joint review described under paragraph (2), 
        the Secretary shall modify the policies of the National 
        Disaster Medical System as necessary.
            (2) Joint review and medical surge capacity 
        strategic plan.--Not later than 180 days after the date 
        of enactment of the Pandemic and All-Hazards 
        Preparedness Act, the Secretary, in coordination with 
        the Secretary of Homeland Security, the Secretary of 
        Defense, and the Secretary of Veterans Affairs, shall 
        conduct a joint review of the National Disaster Medical 
        System. Such review shall include an evaluation of 
        medical surge capacity, as described by section 
        2803(a). As part of the National Health Security 
        Strategy under section 2802, the Secretary shall update 
        the findings from such review and further modify the 
        policies of the National Disaster Medical System as 
        necessary.
            (3) Participation agreements for non-federal 
        entities.--In carrying out paragraph (1), the Secretary 
        shall establish criteria regarding the participation of 
        States and private entities in the National Disaster 
        Medical System, including criteria regarding agreements 
        for such participation. The criteria shall include the 
        following:
                    (A) Provisions relating to the custody and 
                use of Federal personal property by such 
                entities, which may in the discretion of the 
                Secretary include authorizing the custody and 
                use of such property to respond to emergency 
                situations for which the National Disaster 
                Medical System has not been activated by the 
                Secretary pursuant to subsection (a)(3)(A). Any 
                such custody and use of Federal personal 
                property shall be on a reimbursable basis.
                    (B) Provisions relating to circumstances in 
                which an individual or entity has agreements 
                with both the National Disaster Medical System 
                and another entity regarding the provision of 
                emergency services by the individual. Such 
                provisions shall address the issue of 
                priorities among the agreements involved.
    (c) Intermittent Disaster-Response Personnel.--
            (1) In general.--For the purpose of assisting the 
        National Disaster Medical System in carrying out duties 
        under this section, the Secretary may appoint 
        individuals to serve as intermittent personnel of such 
        System in accordance with applicable civil service laws 
        and regulations.
            (2) Liability.--For purposes of section 224(a) and 
        the remedies described in such section, an individual 
        appointed under paragraph (1) shall, while acting 
        within the scope of such appointment, be considered to 
        be an employee of the Public Health Service performing 
        medical, surgical, dental, or related functions. With 
        respect to the participation of individuals appointed 
        under paragraph (1) in training programs authorized by 
        the Assistant Secretary for Preparedness and Response 
        or a comparable official of any Federal agency 
        specified in subsection (a)(2)(B), acts of individuals 
        so appointed that are within the scope of such 
        participation shall be considered within the scope of 
        the appointment under paragraph (1) (regardless of 
        whether the individuals receive compensation for such 
        participation).
    (d) Certain Employment Issues Regarding Intermittent 
Appointments.--
            (1) Intermittent disaster-response appointee.--For 
        purposes of this subsection, the term ``intermittent 
        disaster-response appointee'' means an individual 
        appointed by the Secretary under subsection (c).
            (2) Compensation for work injuries.--An 
        intermittent disaster-response appointee shall, while 
        acting in the scope of such appointment, be considered 
        to be an employee of the Public Health Service 
        performing medical, surgical, dental, or related 
        functions, and an injury sustained by such an 
        individual shall be deemed ``in the performance of 
        duty'', for purposes of chapter 81 of title 5, United 
        States Code, pertaining to compensation for work 
        injuries. With respect to the participation of 
        individuals appointed under subsection (c) in training 
        programs authorized by the Assistant Secretary for 
        Preparedness and Response or a comparable official of 
        any Federal agency specified in subsection (a)(2)(B), 
        injuries sustained by such an individual, while acting 
        within the scope of such participation, also shall be 
        deemed ``in the performance of duty'' for purposes of 
        chapter 81 of title 5, United States Code (regardless 
        of whether the individuals receive compensation for 
        such participation). In the event of an injury to such 
        an intermittent disaster-response appointee, the 
        Secretary of Labor shall be responsible for making 
        determinations as to whether the claimant is entitled 
        to compensation or other benefits in accordance with 
        chapter 81 of title 5, United States Code.
            (3) Employment and reemployment rights.--
                    (A) In general.--Service as an intermittent 
                disaster-response appointee when the Secretary 
                activates the National Disaster Medical System 
                or when the individual participates in a 
                training program authorized by the Assistant 
                Secretary for Preparedness and Response or a 
                comparable official of any Federal agency 
                specified in subsection (a)(2)(B) shall be 
                deemed ``service in the uniformed services'' 
                for purposes of chapter 43 of title 38, United 
                States Code, pertaining to employment and 
                reemployment rights of individuals who have 
                performed service in the uniformed services 
                (regardless of whether the individual receives 
                compensation for such participation). All 
                rights and obligations of such persons and 
                procedures for assistance, enforcement, and 
                investigation shall be as provided for in 
                chapter 43 of title 38, United States Code.
                    (B) Notice of absence from position of 
                employment.--Preclusion of giving notice of 
                service by necessity of Service as an 
                intermittent disaster-response appointee when 
                the Secretary activates the National Disaster 
                Medical System shall be deemed preclusion by 
                ``military necessity'' for purposes of section 
                4312(b) of title 38, United States Code, 
                pertaining to giving notice of absence from a 
                position of employment. A determination of such 
                necessity shall be made by the Secretary, in 
                consultation with the Secretary of Defense, and 
                shall not be subject to judicial review.
            (4) Limitation.--An intermittent disaster-response 
        appointee shall not be deemed an employee of the 
        Department of Health and Human Services for purposes 
        other than those specifically set forth in this 
        section.
    (e) Rule of Construction Regarding Use of Commissioned 
Corps.--If the Secretary assigns commissioned officers of the 
Regular or Reserve Corps to serve with the National Disaster 
Medical System, such assignments do not affect the terms and 
conditions of their appointments as commissioned officers of 
the Regular or Reserve Corps, respectively (including with 
respect to pay and allowances, retirement, benefits, rights, 
privileges, and immunities).
    (f) Definition.--For purposes of this section, the term 
``auxiliary services'' includes mortuary services, veterinary 
services, and other services that are determined by the 
Secretary to be appropriate with respect to the needs referred 
to in subsection (a)(3)(A).
    (g) Authorization of Appropriations.--For the purpose of 
providing for the Assistant Secretary for Preparedness and 
Response and the operations of the National Disaster Medical 
System, other than purposes for which amounts in the Public 
Health Emergency Fund under section 319 are available, there 
are authorized to be appropriated such sums as may be necessary 
for each of the fiscal years 2007 through 2011.

SEC. 2813. [300HH-15] VOLUNTEER MEDICAL RESERVE CORPS.

    (a) In General.--Not later than 180 days after the date of 
enactment of the Pandemic and All-Hazards Preparedness Act, the 
Secretary, in collaboration with State, local, and tribal 
officials, shall build on State, local, and tribal programs in 
existence on the date of enactment of such Act to establish and 
maintain a Medical Reserve Corps (referred to in this section 
as the ``Corps'') to provide for an adequate supply of 
volunteers in the case of a Federal, State, local, or tribal 
public health emergency. The Corps shall be headed by a 
Director who shall be appointed by the Secretary and shall 
oversee the activities of the Corps chapters that exist at the 
State, local, and tribal levels.
    (b) State, Local, and Tribal Coordination.--The Corps shall 
be established using existing State, local, and tribal teams 
and shall not alter such teams.
    (c) Composition.--The Corps shall be composed of 
individuals who--
            (1)(A) are health professionals who have 
        appropriate professional training and expertise as 
        determined appropriate by the Director of the Corps; or
            (B) are non-health professionals who have an 
        interest in serving in an auxiliary or support capacity 
        to facilitate access to health care services in a 
        public health emergency;
            (2) are certified in accordance with the 
        certification program developed under subsection (d);
            (3) are geographically diverse in residence;
            (4) have registered and carry out training 
        exercises with a local chapter of the Medical Reserve 
        Corps; and
            (5) indicate whether they are willing to be 
        deployed outside the area in which they reside in the 
        event of a public health emergency.
    (d) Certification; Drills.--
            (1) Certification.--The Director, in collaboration 
        with State, local, and tribal officials, shall 
        establish a process for the periodic certification of 
        individuals who volunteer for the Corps, as determined 
        by the Secretary, which shall include the completion by 
        each individual of the core training programs developed 
        under section 319F, as required by the Director. Such 
        certification shall not supercede State licensing or 
        credentialing requirements.
            (2) Drills.--In conjunction with the core training 
        programs referred to in paragraph (1), and in order to 
        facilitate the integration of trained volunteers into 
        the health care system at the local level, Corps 
        members shall engage in periodic training exercises to 
        be carried out at the local level.
    (e) Deployment.--During a public health emergency, the 
Secretary shall have the authority to activate and deploy 
willing members of the Corps to areas of need, taking into 
consideration the public health and medical expertise required, 
with the concurrence of the State, local, or tribal officials 
from the area where the members reside.
    (f) Expenses and Transportation.--While engaged in 
performing duties as a member of the Corps pursuant to an 
assignment by the Secretary (including periods of travel to 
facilitate such assignment), members of the Corps who are not 
otherwise employed by the Federal Government shall be allowed 
travel or transportation expenses, including per diem in lieu 
of subsistence.
    (g) Identification.--The Secretary, in cooperation and 
consultation with the States, shall develop a Medical Reserve 
Corps Identification Card that describes the licensure and 
certification information of Corps members, as well as other 
identifying information determined necessary by the Secretary.
    (h) Intermittent Disaster-Response Personnel.--
            (1) In general.--For the purpose of assisting the 
        Corps in carrying out duties under this section, during 
        a public health emergency, the Secretary may appoint 
        selected individuals to serve as intermittent personnel 
        of such Corps in accordance with applicable civil 
        service laws and regulations. In all other cases, 
        members of the Corps are subject to the laws of the 
        State in which the activities of the Corps are 
        undertaken.
            (2) Applicable protections.--Subsections (c)(2), 
        (d), and (e) of section 2812 shall apply to an 
        individual appointed under paragraph (1) in the same 
        manner as such subsections apply to an individual 
        appointed under section 2812(c).
            (3) Limitation.--State, local, and tribal officials 
        shall have no authority to designate a member of the 
        Corps as Federal intermittent disaster-response 
        personnel, but may request the services of such 
        members.
    (i) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section, $22,000,000 for 
fiscal year 2007, and such sums as may be necessary for each of 
fiscal years 2008 through 2011.

SEC. 2814. [300HH-16] AT-RISK INDIVIDUALS.

    The Secretary, acting through such employee of the 
Department of Health and Human Services as determined by the 
Secretary and designated publicly (which may, at the discretion 
of the Secretary, involve the appointment or designation of an 
individual as the Director of At-Risk Individuals), shall--
            (1) oversee the implementation of the National 
        Preparedness goal of taking into account the public 
        health and medical needs of at-risk individuals in the 
        event of a public health emergency, as described in 
        section 2802(b)(4);
            (2) assist other Federal agencies responsible for 
        planning for, responding to, and recovering from public 
        health emergencies in addressing the needs of at-risk 
        individuals;
            (3) provide guidance to and ensure that recipients 
        of State and local public health grants include 
        preparedness and response strategies and capabilities 
        that take into account the medical and public health 
        needs of at-risk individuals in the event of a public 
        health emergency, as described in section 319C-
        1(b)(2)(A)(iii);
            (4) ensure that the contents of the strategic 
        national stockpile take into account at-risk 
        populations as described in section 2811(b)(3)(B);
            (5) oversee the progress of the Advisory Committee 
        on At-Risk Individuals and Public Health Emergencies 
        established under section 319F(b)(2) and make 
        recommendations with a focus on opportunities for 
        action based on the work of the Committee;
            (6) oversee curriculum development for the public 
        health and medical response training program on medical 
        management of casualties, as it concerns at-risk 
        individuals as described in subparagraphs (A) through 
        (C) of section 319F(a)(2);
            (7) disseminate novel and best practices of 
        outreach to and care of at-risk individuals before, 
        during, and following public health emergencies; and
            (8) not later than one year after the date of 
        enactment of the Pandemic and All-Hazards Preparedness 
        Act, prepare and submit to Congress a report describing 
        the progress made on implementing the duties described 
        in this section.

SEC. 2815. [42 U.S.C. 300HH-17] EMERGENCY RESPONSE COORDINATION OF 
                    PRIMARY CARE PROVIDERS.

    The Secretary, acting through Administrator \1\ of the 
Health Resources and Services Administration, and in 
coordination with the Assistant Secretary for Preparedness and 
Response, shall
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    \1\ So in law. Probably should read ``the Administrator''.
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            (1) provide guidance and technical assistance to 
        health centers funded under section 330 and to State 
        and local health departments and emergency managers to 
        integrate health centers into State and local emergency 
        response plans and to better meet the primary care 
        needs of populations served by health centers during 
        public health emergencies; and
            (2) encourage employees at health centers funded 
        under section 330 to participate in emergency medical 
        response programs including the National Disaster 
        Medical System authorized in section 2812, the 
        Volunteer Medical Reserve Corps authorized in section 
        2813, and the Emergency System for Advance Registration 
        of Health Professions Volunteers authorized in section 
        319I.

      Subtitle C--Strengthening Public Health Surveillance Systems

SEC. 2821. [300HH-31] EPIDEMIOLOGY-LABORATORY CAPACITY GRANTS.

    (a) In General.--Subject to the availability of 
appropriations, the Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, shall establish 
an Epidemiology and Laboratory Capacity Grant Program to award 
grants to State health departments as well as local health 
departments and tribal jurisdictions that meet such criteria as 
the Director determines appropriate. Academic centers that 
assist State and eligible local and tribal health departments 
may also be eligible for funding under this section as the 
Director determines appropriate. Grants shall be awarded under 
this section to assist public health agencies in improving 
surveillance for, and response to, infectious diseases and 
other conditions of public health importance by--
            (1) strengthening epidemiologic capacity to 
        identify and monitor the occurrence of infectious 
        diseases and other conditions of public health 
        importance;
            (2) enhancing laboratory practice as well as 
        systems to report test orders and results 
        electronically;
            (3) improving information systems including 
        developing and maintaining an information exchange 
        using national guidelines and complying with capacities 
        and functions determined by an advisory council 
        established and appointed by the Director; and
            (4) developing and implementing prevention and 
        control strategies.
    (b) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section $190,000,000 for 
each of fiscal years 2010 through 2013, of which--
            (1) not less than $95,000,000 shall be made 
        available each such fiscal year for activities under 
        paragraphs (1) and (4) of subsection (a);
            (2) not less than $60,000,000 shall be made 
        available each such fiscal year for activities under 
        subsection (a)(3); and
            (3) not less than $32,000,000 shall be made 
        available each such fiscal year for activities under 
        subsection (a)(2).ATTORNEY: PMG/VLC (July 10, 
        2002) deg.
                   TITLE XXIX--LIFESPAN RESPITE CARE

SEC. 2901. [300II] DEFINITIONS.

    In this title:
            (1) Adult with a special need.--The term ``adult 
        with a special need'' means a person 18 years of age or 
        older who requires care or supervision to--
                    (A) meet the person's basic needs;
                    (B) prevent physical self-injury or injury 
                to others; or
                    (C) avoid placement in an institutional 
                facility.
            (2) Aging and disability resource center.--The term 
        ``aging and disability resource center'' means an 
        entity administering a program established by the 
        State, as part of the State's system of long-term care, 
        to provide a coordinated system for providing--
                    (A) comprehensive information on available 
                public and private long-term care programs, 
                options, and resources;
                    (B) personal counseling to assist 
                individuals in assessing their existing or 
                anticipated long-term care needs, and 
                developing and implementing a plan for long-
                term care designed to meet their specific needs 
                and circumstances; and
                    (C) consumer access to the range of 
                publicly supported long-term care programs for 
                which consumers may be eligible, by serving as 
                a convenient point of entry for such programs.
            (3) Child with a special need.--The term ``child 
        with a special need'' means an individual less than 18 
        years of age who requires care or supervision beyond 
        that required of children generally to--
                    (A) meet the child's basic needs; or
                    (B) prevent physical injury, self-injury, 
                or injury to others.
            (4) Eligible state agency.--The term ``eligible 
        State agency'' means a State agency that--
                    (A) administers the State's program under 
                the Older Americans Act of 1965, administers 
                the State's program under title XIX of the 
                Social Security Act, or is designated by the 
                Governor of such State to administer the 
                State's programs under this title;
                    (B) is an aging and disability resource 
                center;
                    (C) works in collaboration with a public or 
                private nonprofit statewide respite care 
                coalition or organization; and
                    (D) demonstrates--
                            (i) an ability to work with other 
                        State and community-based agencies;
                            (ii) an understanding of respite 
                        care and family caregiver issues across 
                        all age groups, disabilities, and 
                        chronic conditions; and
                            (iii) the capacity to ensure 
                        meaningful involvement of family 
                        members, family caregivers, and care 
                        recipients.
            (5) Family caregiver.--The term ``family 
        caregiver'' means an unpaid family member, a foster 
        parent, or another unpaid adult, who provides in-home 
        monitoring, management, supervision, or treatment of a 
        child or adult with a special need.
            (6) Lifespan respite care.--The term ``lifespan 
        respite care'' means a coordinated system of 
        accessible, community-based respite care services for 
        family caregivers of children or adults with special 
        needs.
            (7) Respite care.--The term ``respite care'' means 
        planned or emergency care provided to a child or adult 
        with a special need in order to provide temporary 
        relief to the family caregiver of that child or adult.
            (8) State.--The term ``State'' means any of the 
        several States, the District of Columbia, the Virgin 
        Islands of the United States, the Commonwealth of 
        Puerto Rico, Guam, American Samoa, and the Commonwealth 
        of the Northern Mariana Islands.

SEC. 2902. [300II-1] LIFESPAN RESPITE CARE GRANTS AND COOPERATIVE 
                    AGREEMENTS.

    (a) Purposes.--The purposes of this section are--
            (1) to expand and enhance respite care services to 
        family caregivers;
            (2) to improve the statewide dissemination and 
        coordination of respite care; and
            (3) to provide, supplement, or improve access and 
        quality of respite care services to family caregivers, 
        thereby reducing family caregiver strain.
    (b) Authorization.--Subject to subsection (e), the 
Secretary is authorized to award grants or cooperative 
agreements for the purposes described in subsection (a) to 
eligible State agencies for which an application is submitted 
pursuant to subsection (d).
    (c) Federal Lifespan Approach.--In carrying out this 
section, the Secretary shall work in cooperation with the 
National Family Caregiver Support Program of the Administration 
on Aging and other respite care programs within the Department 
of Health and Human Services to ensure coordination of respite 
care services for family caregivers of children and adults with 
special needs.
    (d) Application.--
            (1) Submission.--Each Governor desiring the 
        eligible State agency of his or her State to receive a 
        grant or cooperative agreement under this section shall 
        submit an application on behalf of such agency to the 
        Secretary at such time, in such manner, and containing 
        such information as the Secretary shall require.
            (2) Contents.--Each application submitted under 
        this section shall include--
                    (A) a description of the eligible State 
                agency's--
                            (i) ability to work with other 
                        State and community-based agencies;
                            (ii) understanding of respite care 
                        and family caregiver issues across all 
                        age groups, disabilities, and chronic 
                        conditions; and
                            (iii) capacity to ensure meaningful 
                        involvement of family members, family 
                        caregivers, and care recipients;
                    (B) with respect to the population of 
                family caregivers to whom respite care 
                information or services will be provided or for 
                whom respite care workers and volunteers will 
                be recruited and trained, a description of--
                            (i) the population of family 
                        caregivers;
                            (ii) the extent and nature of the 
                        respite care needs of that population;
                            (iii) existing respite care 
                        services for that population, including 
                        numbers of family caregivers being 
                        served and extent of unmet need;
                            (iv) existing methods or systems to 
                        coordinate respite care information and 
                        services to the population at the State 
                        and local level and extent of unmet 
                        need;
                            (v) how respite care information 
                        dissemination and coordination, respite 
                        care services, respite care worker and 
                        volunteer recruitment and training 
                        programs, or training programs for 
                        family caregivers that assist such 
                        family caregivers in making informed 
                        decisions about respite care services 
                        will be provided using grant or 
                        cooperative agreement funds;
                            (vi) a plan for administration, 
                        collaboration, and coordination of the 
                        proposed respite care activities with 
                        other related services or programs 
                        offered by public or private, nonprofit 
                        entities, including area agencies on 
                        aging;
                            (vii) how the population, including 
                        family caregivers, care recipients, and 
                        relevant public or private agencies, 
                        will participate in the planning and 
                        implementation of the proposed respite 
                        care activities;
                            (viii) how the proposed respite 
                        care activities will make use, to the 
                        maximum extent feasible, of other 
                        Federal, State, and local funds, 
                        programs, contributions, other forms of 
                        reimbursements, personnel, and 
                        facilities;
                            (ix) respite care services 
                        available to family caregivers in the 
                        eligible State agency's State or 
                        locality, including unmet needs and how 
                        the eligible State agency's plan for 
                        use of funds will improve the 
                        coordination and distribution of 
                        respite care services for family 
                        caregivers of children and adults with 
                        special needs;
                            (x) the criteria used to identify 
                        family caregivers eligible for respite 
                        care services;
                            (xi) how the quality and safety of 
                        any respite care services provided will 
                        be monitored, including methods to 
                        ensure that respite care workers and 
                        volunteers are appropriately screened 
                        and possess the necessary skills to 
                        care for the needs of the care 
                        recipient in the absence of the family 
                        caregiver; and
                            (xii) the results expected from 
                        proposed respite care activities and 
                        the procedures to be used for 
                        evaluating those results;
                    (C) assurances that, where appropriate, the 
                eligible State agency will have a system for 
                maintaining the confidentiality of care 
                recipient and family caregiver records; and
                    (D) a memorandum of agreement regarding the 
                joint responsibility for the eligible State 
                agency's lifespan respite program between--
                            (i) the eligible State agency; and
                            (ii) a public or private nonprofit 
                        statewide respite coalition or 
                        organization.
    (e) Priority; Considerations.--When awarding grants or 
cooperative agreements under this section, the Secretary 
shall--
            (1) give priority to eligible State agencies that 
        the Secretary determines show the greatest likelihood 
        of implementing or enhancing lifespan respite care 
        statewide; and
            (2) give consideration to eligible State agencies 
        that are building or enhancing the capacity of their 
        long-term care systems to respond to the comprehensive 
        needs, including respite care needs, of their 
        residents.
    (f) Use of Grant or Cooperative Agreement Funds.--
            (1) In general.--
                    (A) Required uses of funds.--Each eligible 
                State agency awarded a grant or cooperative 
                agreement under this section shall use all or 
                part of the funds--
                            (i) to develop or enhance lifespan 
                        respite care at the State and local 
                        levels;
                            (ii) to provide respite care 
                        services for family caregivers caring 
                        for children or adults;
                            (iii) to train and recruit respite 
                        care workers and volunteers;
                            (iv) to provide information to 
                        caregivers about available respite and 
                        support services; and
                            (v) to assist caregivers in gaining 
                        access to such services.
                    (B) Optional uses of funds.--Each eligible 
                State agency awarded a grant or cooperative 
                agreement under this section may use part of 
                the funds for--
                            (i) training programs for family 
                        caregivers to assist such family 
                        caregivers in making informed decisions 
                        about respite care services;
                            (ii) other services essential to 
                        the provision of respite care as the 
                        Secretary may specify; or
                            (iii) training and education for 
                        new caregivers.
            (2) Subcontracts.--Each eligible State agency 
        awarded a grant or cooperative agreement under this 
        section may carry out the activities described in 
        paragraph (1) directly or by grant to, or contract 
        with, public or private entities.
            (3) Matching funds.--
                    (A) In general.--With respect to the costs 
                of the activities to be carried out under 
                paragraph (1), a condition for the receipt of a 
                grant or cooperative agreement under this 
                section is that the eligible State agency 
                agrees to make available (directly or through 
                donations from public or private entities) non-
                Federal contributions toward such costs in an 
                amount that is not less than 25 percent of such 
                costs.
                    (B) Determination of amount contributed.--
                Non-Federal contributions required by 
                subparagraph (A) may be in cash or in kind, 
                fairly evaluated, including plant, equipment, 
                or services. Amounts provided by the Federal 
                Government, or services assisted or subsidized 
                to any significant extent by the Federal 
                Government, may not be included in determining 
                the amount of such non-Federal contributions.
    (g) Term of Grants or Cooperative Agreements.--
            (1) In general.--The Secretary shall award grants 
        or cooperative agreements under this section for terms 
        that do not exceed 5 years.
            (2) Renewal.--The Secretary may renew a grant or 
        cooperative agreement under this section at the end of 
        the term of the grant or cooperative agreement 
        determined under paragraph (1).
    (h) Maintenance of Effort.--Funds made available under this 
section shall be used to supplement and not supplant other 
Federal, State, and local funds available for respite care 
services.

SEC. 2903. [300II-2] NATIONAL LIFESPAN RESPITE RESOURCE CENTER.

    (a) Establishment.--The Secretary may award a grant or 
cooperative agreement to a public or private nonprofit entity 
to establish a National Resource Center on Lifespan Respite 
Care (referred to in this section as the ``center'').
    (b) Purposes of the Center.--The center shall--
            (1) maintain a national database on lifespan 
        respite care;
            (2) provide training and technical assistance to 
        State, community, and nonprofit respite care programs; 
        and
            (3) provide information, referral, and educational 
        programs to the public on lifespan respite care.

SEC. 2904. [300II-3] REPORT.

    Not later than January 1, 2009, the Secretary shall report 
to the Congress on the activities undertaken under this title. 
Such report shall evaluate--
            (1) the number of States that have lifespan respite 
        care programs;
            (2) the demographics of the caregivers receiving 
        respite care services through grants or cooperative 
        agreements under this title; and
            (3) the effectiveness of entities receiving grants 
        or cooperative agreements under this title.

SEC. 2905. [300II-4] AUTHORIZATION OF APPROPRIATIONS.

    There are authorized to be appropriated to carry out this 
title--
            (1) $30,000,000 for fiscal year 2007;
            (2) $40,000,000 for fiscal year 2008;
            (3) $53,330,000 for fiscal year 2009;
            (4) $71,110,000 for fiscal year 2010; and
            (5) $94,810,000 for fiscal year 2011.
          TITLE XXX--HEALTH INFORMATION TECHNOLOGY AND QUALITY

SEC. 3000. [300JJ] DEFINITIONS.

    In this title:
            (1) Certified ehr technology.--The term ``certified 
        EHR technology'' means a qualified electronic health 
        record that is certified pursuant to section 3001(c)(5) 
        as meeting standards adopted under section 3004 that 
        are applicable to the type of record involved (as 
        determined by the Secretary, such as an ambulatory 
        electronic health record for office-based physicians or 
        an inpatient hospital electronic health record for 
        hospitals).
            (2) Enterprise integration.--The term ``enterprise 
        integration'' means the electronic linkage of health 
        care providers, health plans, the government, and other 
        interested parties, to enable the electronic exchange 
        and use of health information among all the components 
        in the health care infrastructure in accordance with 
        applicable law, and such term includes related 
        application protocols and other related standards.
            (3) Health care provider.--The term ``health care 
        provider'' includes a hospital, skilled nursing 
        facility, nursing facility, home health entity or other 
        long term care facility, health care clinic, community 
        mental health center (as defined in section 
        1913(b)(1)), renal dialysis facility, blood center, 
        ambulatory surgical center described in section 1833(i) 
        of the Social Security Act, emergency medical services 
        provider, Federally qualified health center, group 
        practice, a pharmacist, a pharmacy, a laboratory, a 
        physician (as defined in section 1861(r) of the Social 
        Security Act), a practitioner (as described in section 
        1842(b)(18)(C) of the Social Security Act), a provider 
        operated by, or under contract with, the Indian Health 
        Service or by an Indian tribe (as defined in the Indian 
        Self-Determination and Education Assistance Act), 
        tribal organization, or urban Indian organization (as 
        defined in section 4 of the Indian Health Care 
        Improvement Act), a rural health clinic, a covered 
        entity under section 340B, an ambulatory surgical 
        center described in section 1833(i) of the Social 
        Security Act, a therapist (as defined in section 
        1848(k)(3)(B)(iii) of the Social Security Act), and any 
        other category of health care facility, entity, 
        practitioner, or clinician determined appropriate by 
        the Secretary.
            (4) Health information.--The term ``health 
        information'' has the meaning given such term in 
        section 1171(4) of the Social Security Act.
            (5) Health information technology.--The term 
        ``health information technology'' means hardware, 
        software, integrated technologies or related licenses, 
        intellectual property, upgrades, or packaged solutions 
        sold as services that are designed for or support the 
        use by health care entities or patients for the 
        electronic creation, maintenance, access, or exchange 
        of health information
            (6) Health plan.--The term ``health plan'' has the 
        meaning given such term in section 1171(5) of the 
        Social Security Act.
            (7) HIT policy committee.--The term ``HIT Policy 
        Committee'' means such Committee established under 
        section 3002(a).
            (8) HIT standards committee.--The term ``HIT 
        Standards Committee'' means such Committee established 
        under section 3003(a).
            (9) Individually identifiable health information.--
        The term ``individually identifiable health 
        information'' has the meaning given such term in 
        section 1171(6) of the Social Security Act.
            (10) Laboratory.--The term ``laboratory'' has the 
        meaning given such term in section 353(a).
            (11) National coordinator.--The term ``National 
        Coordinator'' means the head of the Office of the 
        National Coordinator for Health Information Technology 
        established under section 3001(a).
            (12) Pharmacist.--The term ``pharmacist'' has the 
        meaning given such term in section 804(2) of the 
        Federal Food, Drug, and Cosmetic Act.
            (13) Qualified electronic health record.--The term 
        ``qualified electronic health record'' means an 
        electronic record of health-related information on an 
        individual that--
                    (A) includes patient demographic and 
                clinical health information, such as medical 
                history and problem lists; and
                    (B) has the capacity--
                            (i) to provide clinical decision 
                        support;
                            (ii) to support physician order 
                        entry;
                            (iii) to capture and query 
                        information relevant to health care 
                        quality; and
                            (iv) to exchange electronic health 
                        information with, and integrate such 
                        information from other sources.
            (14) State.--The term ``State'' means each of the 
        several States, the District of Columbia, Puerto Rico, 
        the Virgin Islands, Guam, American Samoa, and the 
        Northern Mariana Islands.

         Subtitle A--Promotion of Health Information Technology

SEC. 3001. [300JJ-11] OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH 
                    INFORMATION TECHNOLOGY.

    (a) Establishment.--There is established within the 
Department of Health and Human Services an Office of the 
National Coordinator for Health Information Technology 
(referred to in this section as the ``Office''). The Office 
shall be headed by a National Coordinator who shall be 
appointed by the Secretary and shall report directly to the 
Secretary.
    (b) Purpose.--The National Coordinator shall perform the 
duties under subsection (c) in a manner consistent with the 
development of a nationwide health information technology 
infrastructure that allows for the electronic use and exchange 
of information and that--
            (1) ensures that each patient's health information 
        is secure and protected, in accordance with applicable 
        law;
            (2) improves health care quality, reduces medical 
        errors, reduces health disparities, and advances the 
        delivery of patient-centered medical care;
            (3) reduces health care costs resulting from 
        inefficiency, medical errors, inappropriate care, 
        duplicative care, and incomplete information;
            (4) provides appropriate information to help guide 
        medical decisions at the time and place of care;
            (5) ensures the inclusion of meaningful public 
        input in such development of such infrastructure;
            (6) improves the coordination of care and 
        information among hospitals, laboratories, physician 
        offices, and other entities through an effective 
        infrastructure for the secure and authorized exchange 
        of health care information;
            (7) improves public health activities and 
        facilitates the early identification and rapid response 
        to public health threats and emergencies, including 
        bioterror events and infectious disease outbreaks;
            (8) facilitates health and clinical research and 
        health care quality;
            (9) promotes early detection, prevention, and 
        management of chronic diseases;
            (10) promotes a more effective marketplace, greater 
        competition, greater systems analysis, increased 
        consumer choice, and improved outcomes in health care 
        services; and
            (11) improves efforts to reduce health disparities.
    (c) Duties of the National Coordinator.--
            (1) Standards.--The National Coordinator shall--
                    (A) review and determine whether to endorse 
                each standard, implementation specification, 
                and certification criterion for the electronic 
                exchange and use of health information that is 
                recommended by the HIT Standards Committee 
                under section 3003 for purposes of adoption 
                under section 3004;
                    (B) make such determinations under 
                subparagraph (A), and report to the Secretary 
                such determinations, not later than 45 days 
                after the date the recommendation is received 
                by the Coordinator; and
                    (C) review Federal health information 
                technology investments to ensure that Federal 
                health information technology programs are 
                meeting the objectives of the strategic plan 
                published under paragraph (3).
            (2) HIT policy coordination.--
                    (A) In general.--The National Coordinator 
                shall coordinate health information technology 
                policy and programs of the Department with 
                those of other relevant executive branch 
                agencies with a goal of avoiding duplication of 
                efforts and of helping to ensure that each 
                agency undertakes health information technology 
                activities primarily within the areas of its 
                greatest expertise and technical capability and 
                in a manner towards a coordinated national 
                goal.
                    (B) HIT policy and standards committees.--
                The National Coordinator shall be a leading 
                member in the establishment and operations of 
                the HIT Policy Committee and the HIT Standards 
                Committee and shall serve as a liaison among 
                those two Committees and the Federal 
                Government.
            (3) Strategic plan.--
                    (A) In general.--The National Coordinator 
                shall, in consultation with other appropriate 
                Federal agencies (including the National 
                Institute of Standards and Technology), update 
                the Federal Health IT Strategic Plan (developed 
                as of June 3, 2008) to include specific 
                objectives, milestones, and metrics with 
                respect to the following:
                            (i) The electronic exchange and use 
                        of health information and the 
                        enterprise integration of such 
                        information.
                            (ii) The utilization of an 
                        electronic health record for each 
                        person in the United States by 2014.
                            (iii) The incorporation of privacy 
                        and security protections for the 
                        electronic exchange of an individual's 
                        individually identifiable health 
                        information.
                            (iv) Ensuring security methods to 
                        ensure appropriate authorization and 
                        electronic authentication of health 
                        information and specifying technologies 
                        or methodologies for rendering health 
                        information unusable, unreadable, or 
                        indecipherable.
                            (v) Specifying a framework for 
                        coordination and flow of 
                        recommendations and policies under this 
                        subtitle among the Secretary, the 
                        National Coordinator, the HIT Policy 
                        Committee, the HIT Standards Committee, 
                        and other health information exchanges 
                        and other relevant entities.
                            (vi) Methods to foster the public 
                        understanding of health information 
                        technology.
                            (vii) Strategies to enhance the use 
                        of health information technology in 
                        improving the quality of health care, 
                        reducing medical errors, reducing 
                        health disparities, improving public 
                        health, increasing prevention and 
                        coordination with community resources, 
                        and improving the continuity of care 
                        among health care settings.
                            (viii) Specific plans for ensuring 
                        that populations with unique needs, 
                        such as children, are appropriately 
                        addressed in the technology design, as 
                        appropriate, which may include 
                        technology that automates enrollment 
                        and retention for eligible individuals.
                    (B) Collaboration.--The strategic plan 
                shall be updated through collaboration of 
                public and private entities.
                    (C) Measurable outcome goals.--The 
                strategic plan update shall include measurable 
                outcome goals.
                    (D) Publication.--The National Coordinator 
                shall republish the strategic plan, including 
                all updates.
            (4) Website.--The National Coordinator shall 
        maintain and frequently update an Internet website on 
        which there is posted information on the work, 
        schedules, reports, recommendations, and other 
        information to ensure transparency in promotion of a 
        nationwide health information technology 
        infrastructure.
            (5) Certification.--
                    (A) In general.--The National Coordinator, 
                in consultation with the Director of the 
                National Institute of Standards and Technology, 
                shall keep or recognize a program or programs 
                for the voluntary certification of health 
                information technology as being in compliance 
                with applicable certification criteria adopted 
                under this subtitle. Such program shall 
                include, as appropriate, testing of the 
                technology in accordance with section 13201(b) 
                of the Health Information Technology for 
                Economic and Clinical Health Act.
                    (B) Certification criteria described.--In 
                this title, the term ``certification criteria'' 
                means, with respect to standards and 
                implementation specifications for health 
                information technology, criteria to establish 
                that the technology meets such standards and 
                implementation specifications.
            (6) Reports and publications.--
                    (A) Report on additional funding or 
                authority needed.--Not later than 12 months 
                after the date of the enactment of this title, 
                the National Coordinator shall submit to the 
                appropriate committees of jurisdiction of the 
                House of Representatives and the Senate a 
                report on any additional funding or authority 
                the Coordinator or the HIT Policy Committee or 
                HIT Standards Committee requires to evaluate 
                and develop standards, implementation 
                specifications, and certification criteria, or 
                to achieve full participation of stakeholders 
                in the adoption of a nationwide health 
                information technology infrastructure that 
                allows for the electronic use and exchange of 
                health information.
                    (B) Implementation report.--The National 
                Coordinator shall prepare a report that 
                identifies lessons learned from major public 
                and private health care systems in their 
                implementation of health information 
                technology, including information on whether 
                the technologies and practices developed by 
                such systems may be applicable to and usable in 
                whole or in part by other health care 
                providers.
                    (C) Assessment of impact of hit on 
                communities with health disparities and 
                uninsured, underinsured, and medically 
                underserved areas.--The National Coordinator 
                shall assess and publish the impact of health 
                information technology in communities with 
                health disparities and in areas with a high 
                proportion of individuals who are uninsured, 
                underinsured, and medically underserved 
                individuals (including urban and rural areas) 
                and identify practices to increase the adoption 
                of such technology by health care providers in 
                such communities, and the use of health 
                information technology to reduce and better 
                manage chronic diseases.
                    (D) Evaluation of benefits and costs of the 
                electronic use and exchange of health 
                information.--The National Coordinator shall 
                evaluate and publish evidence on the benefits 
                and costs of the electronic use and exchange of 
                health information and assess to whom these 
                benefits and costs accrue.
                    (E) Resource requirements.--The National 
                Coordinator shall estimate and publish 
                resources required annually to reach the goal 
                of utilization of an electronic health record 
                for each person in the United States by 2014, 
                including--
                            (i) the required level of Federal 
                        funding;
                            (ii) expectations for regional, 
                        State, and private investment;
                            (iii) the expected contributions by 
                        volunteers to activities for the 
                        utilization of such records; and
                            (iv) the resources needed to 
                        establish a health information 
                        technology workforce sufficient to 
                        support this effort (including 
                        education programs in medical 
                        informatics and health information 
                        management).
            (7) Assistance.--The National Coordinator may 
        provide financial assistance to consumer advocacy 
        groups and not-for-profit entities that work in the 
        public interest for purposes of defraying the cost to 
        such groups and entities to participate under, whether 
        in whole or in part, the National Technology Transfer 
        Act of 1995 (15 U.S.C. 272 note).
            (8) Governance for nationwide health information 
        network.--The National Coordinator shall establish a 
        governance mechanism for the nationwide health 
        information network.
    (d) Detail of Federal Employees.--
            (1) In general.--Upon the request of the National 
        Coordinator, the head of any Federal agency is 
        authorized to detail, with or without reimbursement 
        from the Office, any of the personnel of such agency to 
        the Office to assist it in carrying out its duties 
        under this section.
            (2) Effect of detail.--Any detail of personnel 
        under paragraph (1) shall--
                    (A) not interrupt or otherwise affect the 
                civil service status or privileges of the 
                Federal employee; and
                    (B) be in addition to any other staff of 
                the Department employed by the National 
                Coordinator.
            (3) Acceptance of detailees.--Notwithstanding any 
        other provision of law, the Office may accept detailed 
        personnel from other Federal agencies without regard to 
        whether the agency described under paragraph (1) is 
        reimbursed.
    (e) Chief Privacy Officer of the Office of the National 
Coordinator.--Not later than 12 months after the date of the 
enactment of this title, the Secretary shall appoint a Chief 
Privacy Officer of the Office of the National Coordinator, 
whose duty it shall be to advise the National Coordinator on 
privacy, security, and data stewardship of electronic health 
information and to coordinate with other Federal agencies (and 
similar privacy officers in such agencies), with State and 
regional efforts, and with foreign countries with regard to the 
privacy, security, and data stewardship of electronic 
individually identifiable health information.

SEC. 3002. [300JJ-12] HIT POLICY COMMITTEE.

    (a) Establishment.--There is established a HIT Policy 
Committee to make policy recommendations to the National 
Coordinator relating to the implementation of a nationwide 
health information technology infrastructure, including 
implementation of the strategic plan described in section 
3001(c)(3).
    (b) Duties.--
            (1) Recommendations on health information 
        technology infrastructure.--The HIT Policy Committee 
        shall recommend a policy framework for the development 
        and adoption of a nationwide health information 
        technology infrastructure that permits the electronic 
        exchange and use of health information as is consistent 
        with the strategic plan under section 3001(c)(3) and 
        that includes the recommendations under paragraph (2). 
        The Committee shall update such recommendations and 
        make new recommendations as appropriate.
            (2) Specific areas of standard development.--
                    (A) In general.--The HIT Policy Committee 
                shall recommend the areas in which standards, 
                implementation specifications, and 
                certification criteria are needed for the 
                electronic exchange and use of health 
                information for purposes of adoption under 
                section 3004 and shall recommend an order of 
                priority for the development, harmonization, 
                and recognition of such standards, 
                specifications, and certification criteria 
                among the areas so recommended. Such standards 
                and implementation specifications shall include 
                named standards, architectures, and software 
                schemes for the authentication and security of 
                individually identifiable health information 
                and other information as needed to ensure the 
                reproducible development of common solutions 
                across disparate entities.
                    (B) Areas required for consideration.--For 
                purposes of subparagraph (A), the HIT Policy 
                Committee shall make recommendations for at 
                least the following areas:
                            (i) Technologies that protect the 
                        privacy of health information and 
                        promote security in a qualified 
                        electronic health record, including for 
                        the segmentation and protection from 
                        disclosure of specific and sensitive 
                        individually identifiable health 
                        information with the goal of minimizing 
                        the reluctance of patients to seek care 
                        (or disclose information about a 
                        condition) because of privacy concerns, 
                        in accordance with applicable law, and 
                        for the use and disclosure of limited 
                        data sets of such information.
                            (ii) A nationwide health 
                        information technology infrastructure 
                        that allows for the electronic use and 
                        accurate exchange of health 
                        information.
                            (iii) The utilization of a 
                        certified electronic health record for 
                        each person in the United States by 
                        2014.
                            (iv) Technologies that as a part of 
                        a qualified electronic health record 
                        allow for an accounting of disclosures 
                        made by a covered entity (as defined 
                        for purposes of regulations promulgated 
                        under section 264(c) of the Health 
                        Insurance Portability and 
                        Accountability Act of 1996) for 
                        purposes of treatment, payment, and 
                        health care operations (as such terms 
                        are defined for purposes of such 
                        regulations).
                            (v) The use of certified electronic 
                        health records to improve the quality 
                        of health care, such as by promoting 
                        the coordination of health care and 
                        improving continuity of health care 
                        among health care providers, by 
                        reducing medical errors, by improving 
                        population health, by reducing health 
                        disparities, by reducing chronic 
                        disease, and by advancing research and 
                        education.
                            (vi) Technologies that allow 
                        individually identifiable health 
                        information to be rendered unusable, 
                        unreadable, or indecipherable to 
                        unauthorized individuals when such 
                        information is transmitted in the 
                        nationwide health information network 
                        or physically transported outside of 
                        the secured, physical perimeter of a 
                        health care provider, health plan, or 
                        health care clearinghouse.
                            (vii) The use of electronic systems 
                        to ensure the comprehensive collection 
                        of patient demographic data, including, 
                        at a minimum, race, ethnicity, primary 
                        language, and gender information.
                            (viii) Technologies that address 
                        the needs of children and other 
                        vulnerable populations.
                    (C) Other areas for consideration.--In 
                making recommendations under subparagraph (A), 
                the HIT Policy Committee may consider the 
                following additional areas:
                            (i) The appropriate uses of a 
                        nationwide health information 
                        infrastructure, including for purposes 
                        of--
                                    (I) the collection of 
                                quality data and public 
                                reporting;
                                    (II) biosurveillance and 
                                public health;
                                    (III) medical and clinical 
                                research; and
                                    (IV) drug safety.
                            (ii) Self-service technologies that 
                        facilitate the use and exchange of 
                        patient information and reduce wait 
                        times.
                            (iii) Telemedicine technologies, in 
                        order to reduce travel requirements for 
                        patients in remote areas.
                            (iv) Technologies that facilitate 
                        home health care and the monitoring of 
                        patients recuperating at home.
                            (v) Technologies that help reduce 
                        medical errors.
                            (vi) Technologies that facilitate 
                        the continuity of care among health 
                        settings.
                            (vii) Technologies that meet the 
                        needs of diverse populations.
                            (viii) Methods to facilitate secure 
                        access by an individual to such 
                        individual's protected health 
                        information.
                            (ix) Methods, guidelines, and 
                        safeguards to facilitate secure access 
                        to patient information by a family 
                        member, caregiver, or guardian acting 
                        on behalf of a patient due to age-
                        related and other disability, cognitive 
                        impairment, or dementia.
                            (x) Any other technology that the 
                        HIT Policy Committee finds to be among 
                        the technologies with the greatest 
                        potential to improve the quality and 
                        efficiency of health care.
            (3) Forum.--The HIT Policy Committee shall serve as 
        a forum for broad stakeholder input with specific 
        expertise in policies relating to the matters described 
        in paragraphs (1) and (2).
            (4) Consistency with evaluation conducted under 
        mippa.--
                    (A) Requirement for consistency.--The HIT 
                Policy Committee shall ensure that 
                recommendations made under paragraph (2)(B)(vi) 
                are consistent with the evaluation conducted 
                under section 1809(a) of the Social Security 
                Act.
                    (B) Scope.--Nothing in subparagraph (A) 
                shall be construed to limit the recommendations 
                under paragraph (2)(B)(vi) to the elements 
                described in section 1809(a)(3) of the Social 
                Security Act.
                    (C) Timing.--The requirement under 
                subparagraph (A) shall be applicable to the 
                extent that evaluations have been conducted 
                under section 1809(a) of the Social Security 
                Act, regardless of whether the report described 
                in subsection (b) of such section has been 
                submitted.
    (c) Membership and Operations.--
            (1) In general.--The National Coordinator shall 
        take a leading position in the establishment and 
        operations of the HIT Policy Committee.
            (2) Membership.--The HIT Policy Committee shall be 
        composed of members to be appointed as follows:
                    (A) 3 members shall be appointed by the 
                Secretary, 1 of whom shall be appointed to 
                represent the Department of Health and Human 
                Services and 1 of whom shall be a public health 
                official.
                    (B) 1 member shall be appointed by the 
                majority leader of the Senate.
                    (C) 1 member shall be appointed by the 
                minority leader of the Senate.
                    (D) 1 member shall be appointed by the 
                Speaker of the House of Representatives.
                    (E) 1 member shall be appointed by the 
                minority leader of the House of 
                Representatives.
                    (F) Such other members as shall be 
                appointed by the President as representatives 
                of other relevant Federal agencies.
                    (G) 13 members shall be appointed by the 
                Comptroller General of the United States of 
                whom--
                            (i) 3 members shall advocates for 
                        patients or consumers;
                            (ii) 2 members shall represent 
                        health care providers, one of which 
                        shall be a physician;
                            (iii) 1 member shall be from a 
                        labor organization representing health 
                        care workers;
                            (iv) 1 member shall have expertise 
                        in health information privacy and 
                        security;
                            (v) 1 member shall have expertise 
                        in improving the health of vulnerable 
                        populations;
                            (vi) 1 member shall be from the 
                        research community;
                            (vii) 1 member shall represent 
                        health plans or other third-party 
                        payers;
                            (viii) 1 member shall represent 
                        information technology vendors;
                            (ix) 1 member shall represent 
                        purchasers or employers; and
                            (x) 1 member shall have expertise 
                        in health care quality measurement and 
                        reporting.
            (3) Participation.--The members of the HIT Policy 
        Committee appointed under paragraph (2) shall represent 
        a balance among various sectors of the health care 
        system so that no single sector unduly influences the 
        recommendations of the Policy Committee.
            (4) Terms.--
                    (A) In general.--The terms of the members 
                of the HIT Policy Committee shall be for 3 
                years, except that the Comptroller General 
                shall designate staggered terms for the members 
                first appointed.
                    (B) Vacancies.--Any member appointed to 
                fill a vacancy in the membership of the HIT 
                Policy Committee that occurs prior to the 
                expiration of the term for which the member's 
                predecessor was appointed shall be appointed 
                only for the remainder of that term. A member 
                may serve after the expiration of that member's 
                term until a successor has been appointed. A 
                vacancy in the HIT Policy Committee shall be 
                filled in the manner in which the original 
                appointment was made.
            (5) Outside involvement.--The HIT Policy Committee 
        shall ensure an opportunity for the participation in 
        activities of the Committee of outside advisors, 
        including individuals with expertise in the development 
        of policies for the electronic exchange and use of 
        health information, including in the areas of health 
        information privacy and security.
            (6) Quorum.--A majority of the member of the HIT 
        Policy Committee shall constitute a quorum for purposes 
        of voting, but a lesser number of members may meet and 
        hold hearings.
            (7) Failure of initial appointment.--If, on the 
        date that is 45 days after the date of enactment of 
        this title, an official authorized under paragraph (2) 
        to appoint one or more members of the HIT Policy 
        Committee has not appointed the full number of members 
        that such paragraph authorizes such official to 
        appoint, the Secretary is authorized to appoint such 
        members.
            (8) Consideration.--The National Coordinator shall 
        ensure that the relevant and available recommendations 
        and comments from the National Committee on Vital and 
        Health Statistics are considered in the development of 
        policies.
    (d) Application of FACA.--The Federal Advisory Committee 
Act (5 U.S.C. App.), other than section 14 of such Act, shall 
apply to the HIT Policy Committee.
    (e) Publication.--The Secretary shall provide for 
publication in the Federal Register and the posting on the 
Internet website of the Office of the National Coordinator for 
Health Information Technology of all policy recommendations 
made by the HIT Policy Committee under this section.

SEC. 3003. [300JJ-13] HIT STANDARDS COMMITTEE.

    (a) Establishment.--There is established a committee to be 
known as the HIT Standards Committee to recommend to the 
National Coordinator standards, implementation specifications, 
and certification criteria for the electronic exchange and use 
of health information for purposes of adoption under section 
3004, consistent with the implementation of the strategic plan 
described in section 3001(c)(3) and beginning with the areas 
listed in section 3002(b)(2)(B) in accordance with policies 
developed by the HIT Policy Committee.
    (b) Duties.--
            (1) Standards development.--
                    (A) In general.--The HIT Standards 
                Committee shall recommend to the National 
                Coordinator standards, implementation 
                specifications, and certification criteria 
                described in subsection (a) that have been 
                developed, harmonized, or recognized by the HIT 
                Standards Committee. The HIT Standards 
                Committee shall update such recommendations and 
                make new recommendations as appropriate, 
                including in response to a notification sent 
                under section 3004(a)(2)(B). Such 
                recommendations shall be consistent with the 
                latest recommendations made by the HIT Policy 
                Committee.
                    (B) Harmonization.--The HIT Standards 
                Committee recognize harmonized or updated 
                standards from an entity or entities for the 
                purpose of harmonizing or updating standards 
                and implementation specifications in order to 
                achieve uniform and consistent implementation 
                of the standards and implementation 
                specifications.
                    (C) Pilot testing of standards and 
                implementation specifications.--In the 
                development, harmonization, or recognition of 
                standards and implementation specifications, 
                the HIT Standards Committee shall, as 
                appropriate, provide for the testing of such 
                standards and specifications by the National 
                Institute for Standards and Technology under 
                section 13201(a) of the Health Information 
                Technology for Economic and Clinical Health 
                Act.
                    (D) Consistency.--The standards, 
                implementation specifications, and 
                certification criteria recommended under this 
                subsection shall be consistent with the 
                standards for information transactions and data 
                elements adopted pursuant to section 1173 of 
                the Social Security Act.
            (2) Forum.--The HIT Standards Committee shall serve 
        as a forum for the participation of a broad range of 
        stakeholders to provide input on the development, 
        harmonization, and recognition of standards, 
        implementation specifications, and certification 
        criteria necessary for the development and adoption of 
        a nationwide health information technology 
        infrastructure that allows for the electronic use and 
        exchange of health information.
            (3) Schedule.--Not later than 90 days after the 
        date of the enactment of this title, the HIT Standards 
        Committee shall develop a schedule for the assessment 
        of policy recommendations developed by the HIT Policy 
        Committee under section 3002. The HIT Standards 
        Committee shall update such schedule annually. The 
        Secretary shall publish such schedule in the Federal 
        Register.
            (4) Public input.--The HIT Standards Committee 
        shall conduct open public meetings and develop a 
        process to allow for public comment on the schedule 
        described in paragraph (3) and recommendations 
        described in this subsection. Under such process 
        comments shall be submitted in a timely manner after 
        the date of publication of a recommendation under this 
        subsection.
            (5) Consideration.--The National Coordinator shall 
        ensure that the relevant and available recommendations 
        and comments from the National Committee on Vital and 
        Health Statistics are considered in the development of 
        standards.
    (c) Membership and Operations.--
            (1) In general.--The National Coordinator shall 
        take a leading position in the establishment and 
        operations of the HIT Standards Committee.
            (2) Membership.--The membership of the HIT 
        Standards Committee shall at least reflect providers, 
        ancillary healthcare workers, consumers, purchasers, 
        health plans, technology vendors, researchers, relevant 
        Federal agencies, and individuals with technical 
        expertise on health care quality, privacy and security, 
        and on the electronic exchange and use of health 
        information.
            (3) Participation.--The members of the HIT 
        Standards Committee appointed under this subsection 
        shall represent a balance among various sectors of the 
        health care system so that no single sector unduly 
        influences the recommendations of such Committee.
            (4) Outside involvement.--The HIT Policy Committee 
        shall ensure an opportunity for the participation in 
        activities of the Committee of outside advisors, 
        including individuals with expertise in the development 
        of standards for the electronic exchange and use of 
        health information, including in the areas of health 
        information privacy and security.
            (5) Balance among sectors.--In developing the 
        procedures for conducting the activities of the HIT 
        Standards Committee, the HIT Standards Committee shall 
        act to ensure a balance among various sectors of the 
        health care system so that no single sector unduly 
        influences the actions of the HIT Standards Committee.
            (6) Assistance.--For the purposes of carrying out 
        this section, the Secretary may provide or ensure that 
        financial assistance is provided by the HIT Standards 
        Committee to defray in whole or in part any membership 
        fees or dues charged by such Committee to those 
        consumer advocacy groups and not for profit entities 
        that work in the public interest as a part of their 
        mission.
    (d) Application of FACA.--The Federal Advisory Committee 
Act (5 U.S.C. App.), other than section 14, shall apply to the 
HIT Standards Committee.
    (e) Publication.--The Secretary shall provide for 
publication in the Federal Register and the posting on the 
Internet website of the Office of the National Coordinator for 
Health Information Technology of all recommendations made by 
the HIT Standards Committee under this section.

SEC. 3004. [300JJ-14] PROCESS FOR ADOPTION OF ENDORSED RECOMMENDATIONS; 
                    ADOPTION OF INITIAL SET OF STANDARDS, 
                    IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION 
                    CRITERIA.

    (a) Process for Adoption of Endorsed Recommendations.--
            (1) Review of endorsed standards, implementation 
        specifications, and certification criteria.--Not later 
        than 90 days after the date of receipt of standards, 
        implementation specifications, or certification 
        criteria endorsed under section 3001(c), the Secretary, 
        in consultation with representatives of other relevant 
        Federal agencies, shall jointly review such standards, 
        implementation specifications, or certification 
        criteria and shall determine whether or not to propose 
        adoption of such standards, implementation 
        specifications, or certification criteria.
            (2) Determination to adopt standards, 
        implementation specifications, and certification 
        criteria.--If the Secretary determines--
                    (A) to propose adoption of any grouping of 
                such standards, implementation specifications, 
                or certification criteria, the Secretary shall, 
                by regulation under section 553 of title 5, 
                United States Code, determine whether or not to 
                adopt such grouping of standards, 
                implementation specifications, or certification 
                criteria; or
                    (B) not to propose adoption of any grouping 
                of standards, implementation specifications, or 
                certification criteria, the Secretary shall 
                notify the National Coordinator and the HIT 
                Standards Committee in writing of such 
                determination and the reasons for not proposing 
                the adoption of such recommendation.
            (3) Publication.--The Secretary shall provide for 
        publication in the Federal Register of all 
        determinations made by the Secretary under paragraph 
        (1).
    (b) Adoption of Standards, Implementation Specifications, 
and Certification Criteria.--
            (1) In general.--Not later than December 31, 2009, 
        the Secretary shall, through the rulemaking process 
        consistent with subsection (a)(2)(A), adopt an initial 
        set of standards, implementation specifications, and 
        certification criteria for the areas required for 
        consideration under section 3002(b)(2)(B). The 
        rulemaking for the initial set of standards, 
        implementation specifications, and certification 
        criteria may be issued on an interim, final basis.
            (2) Application of current standards, 
        implementation specifications, and certification 
        criteria.--The standards, implementation 
        specifications, and certification criteria adopted 
        before the date of the enactment of this title through 
        the process existing through the Office of the National 
        Coordinator for Health Information Technology may be 
        applied towards meeting the requirement of paragraph 
        (1).
            (3) Subsequent standards activity.--The Secretary 
        shall adopt additional standards, implementation 
        specifications, and certification criteria as necessary 
        and consistent with the schedule published under 
        section 3003(b)(2).

SEC. 3005. [300JJ-15] APPLICATION AND USE OF ADOPTED STANDARDS AND 
                    IMPLEMENTATION SPECIFICATIONS BY FEDERAL AGENCIES.

    For requirements relating to the application and use by 
Federal agencies of the standards and implementation 
specifications adopted under section 3004, see section 13111 of 
the Health Information Technology for Economic and Clinical 
Health Act.

SEC. 3006. [300JJ-16] VOLUNTARY APPLICATION AND USE OF ADOPTED 
                    STANDARDS AND IMPLEMENTATION SPECIFICATIONS BY 
                    PRIVATE ENTITIES.

    (a) In General.--Except as provided under section 13112 of 
the HITECH Act, nothing in such Act or in the amendments made 
by such Act shall be construed--
            (1) to require a private entity to adopt or comply 
        with a standard or implementation specification adopted 
        under section 3004; or
            (2) to provide a Federal agency authority, other 
        than the authority such agency may have under other 
        provisions of law, to require a private entity to 
        comply with such a standard or implementation 
        specification.
    (b) Rule of Construction.--Nothing in this subtitle shall 
be construed to require that a private entity that enters into 
a contract with the Federal Government apply or use the 
standards and implementation specifications adopted under 
section 3004 with respect to activities not related to the 
contract.

SEC. 3007. [300JJ-17] FEDERAL HEALTH INFORMATION TECHNOLOGY.

    (a) In General.--The National Coordinator shall support the 
development and routine updating of qualified electronic health 
record technology (as defined in section 3000) consistent with 
subsections (b) and (c) and make available such qualified 
electronic health record technology unless the Secretary 
determines through an assessment that the needs and demands of 
providers are being substantially and adequately met through 
the marketplace.
    (b) Certification.--In making such electronic health record 
technology publicly available, the National Coordinator shall 
ensure that the qualified electronic health record technology 
described in subsection (a) is certified under the program 
developed under section 3001(c)(3) to be in compliance with 
applicable standards adopted under section 3003(a).
    (c) Authorization To Charge a Nominal Fee.--The National 
Coordinator may impose a nominal fee for the adoption by a 
health care provider of the health information technology 
system developed or approved under subsection (a) and (b). Such 
fee shall take into account the financial circumstances of 
smaller providers, low income providers, and providers located 
in rural or other medically underserved areas.
    (d) Rule of Construction.--Nothing in this section shall be 
construed to require that a private or government entity adopt 
or use the technology provided under this section.

SEC. 3008. [300JJ-18] TRANSITIONS.

    (a) ONCHIT.--To the extent consistent with section 3001, 
all functions, personnel, assets, liabilities, and 
administrative actions applicable to the National Coordinator 
for Health Information Technology appointed under Executive 
Order No. 13335 or the Office of such National Coordinator on 
the date before the date of the enactment of this title shall 
be transferred to the National Coordinator appointed under 
section 3001(a) and the Office of such National Coordinator as 
of the date of the enactment of this title.
    (b) National EHealth Collaborative.--Nothing in sections 
3002 or 3003 or this subsection shall be construed as 
prohibiting the AHIC Successor, Inc. doing business as the 
National eHealth Collaborative from modifying its charter, 
duties, membership, and any other structure or function 
required to be consistent with section 3002 and 3003 so as to 
allow the Secretary to recognize such AHIC Successor, Inc. as 
the HIT Policy Committee or the HIT Standards Committee.
    (c) Consistency of Recommendations.--In carrying out 
section 3003(b)(1)(A), until recommendations are made by the 
HIT Policy Committee, recommendations of the HIT Standards 
Committee shall be consistent with the most recent 
recommendations made by such AHIC Successor, Inc.

SEC. 3009. [300JJ-19] MISCELLANEOUS PROVISIONS.

    (a) Relation to HIPAA Privacy and Security Law.--
            (1) In general.--With respect to the relation of 
        this title to HIPAA privacy and security law:
                    (A) This title may not be construed as 
                having any effect on the authorities of the 
                Secretary under HIPAA privacy and security law.
                    (B) The purposes of this title include 
                ensuring that the health information technology 
                standards and implementation specifications 
                adopted under section 3004 take into account 
                the requirements of HIPAA privacy and security 
                law.
            (2) Definition.--For purposes of this section, the 
        term ``HIPAA privacy and security law'' means--
                    (A) the provisions of part C of title XI of 
                the Social Security Act, section 264 of the 
                Health Insurance Portability and Accountability 
                Act of 1996, and subtitle D of title IV of the 
                Health Information Technology for Economic and 
                Clinical Health Act; and
                    (B) regulations under such provisions.
    (b) Flexibility.--In administering the provisions of this 
title, the Secretary shall have flexibility in applying the 
definition of health care provider under section 3000(3), 
including the authority to omit certain entities listed in such 
definition when applying such definition under this title, 
where appropriate.

  Subtitle B--Incentives for the Use of Health Information Technology

SEC. 3011. [300JJ-31] IMMEDIATE FUNDING TO STRENGTHEN THE HEALTH 
                    INFORMATION TECHNOLOGY INFRASTRUCTURE.

    (a) In General.--The Secretary shall, using amounts 
appropriated under section 3018, invest in the infrastructure 
necessary to allow for and promote the electronic exchange and 
use of health information for each individual in the United 
States consistent with the goals outlined in the strategic plan 
developed by the National Coordinator (and as available) under 
section 3001. The Secretary shall invest funds through the 
different agencies with expertise in such goals, such as the 
Office of the National Coordinator for Health Information 
Technology, the Health Resources and Services Administration, 
the Agency for Healthcare Research and Quality, the Centers of 
Medicare & Medicaid Services, the Centers for Disease Control 
and Prevention, and the Indian Health Service to support the 
following:
            (1) Health information technology architecture that 
        will support the nationwide electronic exchange and use 
        of health information in a secure, private, and 
        accurate manner, including connecting health 
        information exchanges, and which may include updating 
        and implementing the infrastructure necessary within 
        different agencies of the Department of Health and 
        Human Services to support the electronic use and 
        exchange of health information.
            (2) Development and adoption of appropriate 
        certified electronic health records for categories of 
        health care providers not eligible for support under 
        title XVIII or XIX of the Social Security Act for the 
        adoption of such records.
            (3) Training on and dissemination of information on 
        best practices to integrate health information 
        technology, including electronic health records, into a 
        provider's delivery of care, consistent with best 
        practices learned from the Health Information 
        Technology Research Center developed under section 
        3012(b), including community health centers receiving 
        assistance under section 330, covered entities under 
        section 340B, and providers participating in one or 
        more of the programs under titles XVIII, XIX, and XXI 
        of the Social Security Act (relating to Medicare, 
        Medicaid, and the State Children's Health Insurance 
        Program).
            (4) Infrastructure and tools for the promotion of 
        telemedicine, including coordination among Federal 
        agencies in the promotion of telemedicine.
            (5) Promotion of the interoperability of clinical 
        data repositories or registries.
            (6) Promotion of technologies and best practices 
        that enhance the protection of health information by 
        all holders of individually identifiable health 
        information.
            (7) Improvement and expansion of the use of health 
        information technology by public health departments.
    (b) Coordination.--The Secretary shall ensure funds under 
this section are used in a coordinated manner with other health 
information promotion activities.
    (c) Additional Use of Funds.--In addition to using funds as 
provided in subsection (a), the Secretary may use amounts 
appropriated under section 3018 to carry out health information 
technology activities that are provided for under laws in 
effect on the date of the enactment of this title.
    (d) Standards for Acquisition of Health Information 
Technology.--To the greatest extent practicable, the Secretary 
shall ensure that where funds are expended under this section 
for the acquisition of health information technology, such 
funds shall be used to acquire health information technology 
that meets applicable standards adopted under section 3004. 
Where it is not practicable to expend funds on health 
information technology that meets such applicable standards, 
the Secretary shall ensure that such health information 
technology meets applicable standards otherwise adopted by the 
Secretary.

SEC. 3012. [300JJ-32] HEALTH INFORMATION TECHNOLOGY IMPLEMENTATION 
                    ASSISTANCE.

    (a) Health Information Technology Extension Program.--To 
assist health care providers to adopt, implement, and 
effectively use certified EHR technology that allows for the 
electronic exchange and use of health information, the 
Secretary, acting through the Office of the National 
Coordinator, shall establish a health information technology 
extension program to provide health information technology 
assistance services to be carried out through the Department of 
Health and Human Services. The National Coordinator shall 
consult with other Federal agencies with demonstrated 
experience and expertise in information technology services, 
such as the National Institute of Standards and Technology, in 
developing and implementing this program.
    (b) Health Information Technology Research Center.--
            (1) In general.--The Secretary shall create a 
        Health Information Technology Research Center (in this 
        section referred to as the ``Center'') to provide 
        technical assistance and develop or recognize best 
        practices to support and accelerate efforts to adopt, 
        implement, and effectively utilize health information 
        technology that allows for the electronic exchange and 
        use of information in compliance with standards, 
        implementation specifications, and certification 
        criteria adopted under section 3004.
            (2) Input.--The Center shall incorporate input 
        from--
                    (A) other Federal agencies with 
                demonstrated experience and expertise in 
                information technology services such as the 
                National Institute of Standards and Technology;
                    (B) users of health information technology, 
                such as providers and their support and 
                clerical staff and others involved in the care 
                and care coordination of patients, from the 
                health care and health information technology 
                industry; and
                    (C) others as appropriate.
            (3) Purposes.--The purposes of the Center are to--
                    (A) provide a forum for the exchange of 
                knowledge and experience;
                    (B) accelerate the transfer of lessons 
                learned from existing public and private sector 
                initiatives, including those currently 
                receiving Federal financial support;
                    (C) assemble, analyze, and widely 
                disseminate evidence and experience related to 
                the adoption, implementation, and effective use 
                of health information technology that allows 
                for the electronic exchange and use of 
                information including through the regional 
                centers described in subsection (c);
                    (D) provide technical assistance for the 
                establishment and evaluation of regional and 
                local health information networks to facilitate 
                the electronic exchange of information across 
                health care settings and improve the quality of 
                health care;
                    (E) provide technical assistance for the 
                development and dissemination of solutions to 
                barriers to the exchange of electronic health 
                information; and
                    (F) learn about effective strategies to 
                adopt and utilize health information technology 
                in medically underserved communities.
    (c) Health Information Technology Regional Extension 
Centers.--
            (1) In general.--The Secretary shall provide 
        assistance for the creation and support of regional 
        centers (in this subsection referred to as ``regional 
        centers'') to provide technical assistance and 
        disseminate best practices and other information 
        learned from the Center to support and accelerate 
        efforts to adopt, implement, and effectively utilize 
        health information technology that allows for the 
        electronic exchange and use of information in 
        compliance with standards, implementation 
        specifications, and certification criteria adopted 
        under section 3004. Activities conducted under this 
        subsection shall be consistent with the strategic plan 
        developed by the National Coordinator, (and, as 
        available) under section 3001.
            (2) Affiliation.--Regional centers shall be 
        affiliated with any United States-based nonprofit 
        institution or organization, or group thereof, that 
        applies and is awarded financial assistance under this 
        section. Individual awards shall be decided on the 
        basis of merit.
            (3) Objective.--The objective of the regional 
        centers is to enhance and promote the adoption of 
        health information technology through--
                    (A) assistance with the implementation, 
                effective use, upgrading, and ongoing 
                maintenance of health information technology, 
                including electronic health records, to 
                healthcare providers nationwide;
                    (B) broad participation of individuals from 
                industry, universities, and State governments;
                    (C) active dissemination of best practices 
                and research on the implementation, effective 
                use, upgrading, and ongoing maintenance of 
                health information technology, including 
                electronic health records, to health care 
                providers in order to improve the quality of 
                healthcare and protect the privacy and security 
                of health information;
                    (D) participation, to the extent 
                practicable, in health information exchanges;
                    (E) utilization, when appropriate, of the 
                expertise and capability that exists in Federal 
                agencies other than the Department; and
                    (F) integration of health information 
                technology, including electronic health 
                records, into the initial and ongoing training 
                of health professionals and others in the 
                healthcare industry that would be instrumental 
                to improving the quality of healthcare through 
                the smooth and accurate electronic use and 
                exchange of health information.
            (4) Regional assistance.--Each regional center 
        shall aim to provide assistance and education to all 
        providers in a region, but shall prioritize any direct 
        assistance first to the following:
                    (A) Public or not-for-profit hospitals or 
                critical access hospitals.
                    (B) Federally qualified health centers (as 
                defined in section 1861(aa)(4) of the Social 
                Security Act).
                    (C) Entities that are located in rural and 
                other areas that serve uninsured, underinsured, 
                and medically underserved individuals 
                (regardless of whether such area is urban or 
                rural).
                    (D) Individual or small group practices (or 
                a consortium thereof) that are primarily 
                focused on primary care.
            (5) Financial support.--The Secretary may provide 
        financial support to any regional center created under 
        this subsection for a period not to exceed four years. 
        The Secretary may not provide more than 50 percent of 
        the capital and annual operating and maintenance funds 
        required to create and maintain such a center, except 
        in an instance of national economic conditions which 
        would render this cost-share requirement detrimental to 
        the program and upon notification to Congress as to the 
        justification to waive the cost-share requirement.
            (6) Notice of program description and availability 
        of funds.--The Secretary shall publish in the Federal 
        Register, not later than 90 days after the date of the 
        enactment of this title, a draft description of the 
        program for establishing regional centers under this 
        subsection. Such description shall include the 
        following:
                    (A) A detailed explanation of the program 
                and the programs goals.
                    (B) Procedures to be followed by the 
                applicants.
                    (C) Criteria for determining qualified 
                applicants.
                    (D) Maximum support levels expected to be 
                available to centers under the program.
            (7) Application review.--The Secretary shall 
        subject each application under this subsection to merit 
        review. In making a decision whether to approve such 
        application and provide financial support, the 
        Secretary shall consider at a minimum the merits of the 
        application, including those portions of the 
        application regarding--
                    (A) the ability of the applicant to provide 
                assistance under this subsection and 
                utilization of health information technology 
                appropriate to the needs of particular 
                categories of health care providers;
                    (B) the types of service to be provided to 
                health care providers;
                    (C) geographical diversity and extent of 
                service area; and
                    (D) the percentage of funding and amount of 
                in-kind commitment from other sources.
            (8) Biennial evaluation.--Each regional center 
        which receives financial assistance under this 
        subsection shall be evaluated biennially by an 
        evaluation panel appointed by the Secretary. Each 
        evaluation panel shall be composed of private experts, 
        none of whom shall be connected with the center 
        involved, and of Federal officials. Each evaluation 
        panel shall measure the involved center's performance 
        against the objective specified in paragraph (3). The 
        Secretary shall not continue to provide funding to a 
        regional center unless its evaluation is overall 
        positive.
            (9) Continuing support.--After the second year of 
        assistance under this subsection, a regional center may 
        receive additional support under this subsection if it 
        has received positive evaluations and a finding by the 
        Secretary that continuation of Federal funding to the 
        center was in the best interest of provision of health 
        information technology extension services.

SEC. 3013. [300JJ-33] STATE GRANTS TO PROMOTE HEALTH INFORMATION 
                    TECHNOLOGY.

    (a) In General.--The Secretary, acting through the National 
Coordinator, shall establish a program in accordance with this 
section to facilitate and expand the electronic movement and 
use of health information among organizations according to 
nationally recognized standards.
    (b) Planning Grants.--The Secretary may award a grant to a 
State or qualified State-designated entity (as described in 
subsection (f)) that submits an application to the Secretary at 
such time, in such manner, and containing such information as 
the Secretary may specify, for the purpose of planning 
activities described in subsection (d).
    (c) Implementation Grants.--The Secretary may award a grant 
to a State or qualified State designated entity that--
            (1) has submitted, and the Secretary has approved, 
        a plan described in subsection (e) (regardless of 
        whether such plan was prepared using amounts awarded 
        under subsection (b); and
            (2) submits an application at such time, in such 
        manner, and containing such information as the 
        Secretary may specify.
    (d) Use of Funds.--Amounts received under a grant under 
subsection (c) shall be used to conduct activities to 
facilitate and expand the electronic movement and use of health 
information among organizations according to nationally 
recognized standards through activities that include--
            (1) enhancing broad and varied participation in the 
        authorized and secure nationwide electronic use and 
        exchange of health information;
            (2) identifying State or local resources available 
        towards a nationwide effort to promote health 
        information technology;
            (3) complementing other Federal grants, programs, 
        and efforts towards the promotion of health information 
        technology;
            (4) providing technical assistance for the 
        development and dissemination of solutions to barriers 
        to the exchange of electronic health information;
            (5) promoting effective strategies to adopt and 
        utilize health information technology in medically 
        underserved communities;
            (6) assisting patients in utilizing health 
        information technology;
            (7) encouraging clinicians to work with Health 
        Information Technology Regional Extension Centers as 
        described in section 3012, to the extent they are 
        available and valuable;
            (8) supporting public health agencies' authorized 
        use of and access to electronic health information;
            (9) promoting the use of electronic health records 
        for quality improvement including through quality 
        measures reporting; and
            (10) such other activities as the Secretary may 
        specify.
    (e) Plan.--
            (1) In general.--A plan described in this 
        subsection is a plan that describes the activities to 
        be carried out by a State or by the qualified State-
        designated entity within such State to facilitate and 
        expand the electronic movement and use of health 
        information among organizations according to nationally 
        recognized standards and implementation specifications.
            (2) Required elements.--A plan described in 
        paragraph (1) shall--
                    (A) be pursued in the public interest;
                    (B) be consistent with the strategic plan 
                developed by the National Coordinator, (and, as 
                available) under section 3001;
                    (C) include a description of the ways the 
                State or qualified State-designated entity will 
                carry out the activities described in 
                subsection (b); and
                    (D) contain such elements as the Secretary 
                may require.
    (f) Qualified State-Designated Entity.--For purposes of 
this section, to be a qualified State-designated entity, with 
respect to a State, an entity shall--
            (1) be designated by the State as eligible to 
        receive awards under this section;
            (2) be a not-for-profit entity with broad 
        stakeholder representation on its governing board;
            (3) demonstrate that one of its principal goals is 
        to use information technology to improve health care 
        quality and efficiency through the authorized and 
        secure electronic exchange and use of health 
        information;
            (4) adopt nondiscrimination and conflict of 
        interest policies that demonstrate a commitment to 
        open, fair, and nondiscriminatory participation by 
        stakeholders; and
            (5) conform to such other requirements as the 
        Secretary may establish.
    (g) Required Consultation.--In carrying out activities 
described in subsections (b) and (c), a State or qualified 
State-designated entity shall consult with and consider the 
recommendations of--
            (1) health care providers (including providers that 
        provide services to low income and underserved 
        populations);
            (2) health plans;
            (3) patient or consumer organizations that 
        represent the population to be served;
            (4) health information technology vendors;
            (5) health care purchasers and employers;
            (6) public health agencies;
            (7) health professions schools, universities and 
        colleges;
            (8) clinical researchers;
            (9) other users of health information technology 
        such as the support and clerical staff of providers and 
        others involved in the care and care coordination of 
        patients; and
            (10) such other entities, as may be determined 
        appropriate by the Secretary.
    (h) Continuous Improvement.--The Secretary shall annually 
evaluate the activities conducted under this section and shall, 
in awarding grants under this section, implement the lessons 
learned from such evaluation in a manner so that awards made 
subsequent to each such evaluation are made in a manner that, 
in the determination of the Secretary, will lead towards the 
greatest improvement in quality of care, decrease in costs, and 
the most effective authorized and secure electronic exchange of 
health information.
    (i) Required Match.--
            (1) In general.--For a fiscal year (beginning with 
        fiscal year 2011), the Secretary may not make a grant 
        under this section to a State unless the State agrees 
        to make available non-Federal contributions (which may 
        include in-kind contributions) toward the costs of a 
        grant awarded under subsection (c) in an amount equal 
        to--
                    (A) for fiscal year 2011, not less than $1 
                for each $10 of Federal funds provided under 
                the grant;
                    (B) for fiscal year 2012, not less than $1 
                for each $7 of Federal funds provided under the 
                grant; and
                    (C) for fiscal year 2013 and each 
                subsequent fiscal year, not less than $1 for 
                each $3 of Federal funds provided under the 
                grant.
            (2) Authority to require state match for fiscal 
        years before fiscal year 2011.--For any fiscal year 
        during the grant program under this section before 
        fiscal year 2011, the Secretary may determine the 
        extent to which there shall be required a non-Federal 
        contribution from a State receiving a grant under this 
        section.

SEC. 3014. [300JJ-34] COMPETITIVE GRANTS TO STATES AND INDIAN TRIBES 
                    FOR THE DEVELOPMENT OF LOAN PROGRAMS TO FACILITATE 
                    THE WIDESPREAD ADOPTION OF CERTIFIED EHR 
                    TECHNOLOGY.

    (a) In General.--The National Coordinator may award 
competitive grants to eligible entities for the establishment 
of programs for loans to health care providers to conduct the 
activities described in subsection (e).
    (b) Eligible Entity Defined.--For purposes of this 
subsection, the term ``eligible entity'' means a State or 
Indian tribe (as defined in the Indian Self-Determination and 
Education Assistance Act) that--
            (1) submits to the National Coordinator an 
        application at such time, in such manner, and 
        containing such information as the National Coordinator 
        may require;
            (2) submits to the National Coordinator a strategic 
        plan in accordance with subsection (d) and provides to 
        the National Coordinator assurances that the entity 
        will update such plan annually in accordance with such 
        subsection;
            (3) provides assurances to the National Coordinator 
        that the entity will establish a Loan Fund in 
        accordance with subsection (c);
            (4) provides assurances to the National Coordinator 
        that the entity will not provide a loan from the Loan 
        Fund to a health care provider unless the provider 
        agrees to--
                    (A) submit reports on quality measures 
                adopted by the Federal Government (by not later 
                than 90 days after the date on which such 
                measures are adopted), to--
                            (i) the Administrator of the 
                        Centers for Medicare & Medicaid 
                        Services (or his or her designee), in 
                        the case of an entity participating in 
                        the Medicare program under title XVIII 
                        of the Social Security Act or the 
                        Medicaid program under title XIX of 
                        such Act; or
                            (ii) the Secretary in the case of 
                        other entities;
                    (B) demonstrate to the satisfaction of the 
                Secretary (through criteria established by the 
                Secretary) that any certified EHR technology 
                purchased, improved, or otherwise financially 
                supported under a loan under this section is 
                used to exchange health information in a manner 
                that, in accordance with law and standards (as 
                adopted under section 3004) applicable to the 
                exchange of information, improves the quality 
                of health care, such as promoting care 
                coordination; and
                    (C) comply with such other requirements as 
                the entity or the Secretary may require;
                    (D) include a plan on how health care 
                providers involved intend to maintain and 
                support the certified EHR technology over time;
                    (E) include a plan on how the health care 
                providers involved intend to maintain and 
                support the certified EHR technology that would 
                be purchased with such loan, including the type 
                of resources expected to be involved and any 
                such other information as the State or Indian 
                Tribe, respectively, may require; and
            (5) agrees to provide matching funds in accordance 
        with subsection (h).
    (c) Establishment of Fund.--For purposes of subsection 
(b)(3), an eligible entity shall establish a certified EHR 
technology loan fund (referred to in this subsection as a 
``Loan Fund'') and comply with the other requirements contained 
in this section. A grant to an eligible entity under this 
section shall be deposited in the Loan Fund established by the 
eligible entity. No funds authorized by other provisions of 
this title to be used for other purposes specified in this 
title shall be deposited in any Loan Fund.
    (d) Strategic Plan.--
            (1) In general.--For purposes of subsection (b)(2), 
        a strategic plan of an eligible entity under this 
        subsection shall identify the intended uses of amounts 
        available to the Loan Fund of such entity.
            (2) Contents.--A strategic plan under paragraph 
        (1), with respect to a Loan Fund of an eligible entity, 
        shall include for a year the following:
                    (A) A list of the projects to be assisted 
                through the Loan Fund during such year.
                    (B) A description of the criteria and 
                methods established for the distribution of 
                funds from the Loan Fund during the year.
                    (C) A description of the financial status 
                of the Loan Fund as of the date of submission 
                of the plan.
                    (D) The short-term and long-term goals of 
                the Loan Fund.
    (e) Use of Funds.--Amounts deposited in a Loan Fund, 
including loan repayments and interest earned on such amounts, 
shall be used only for awarding loans or loan guarantees, 
making reimbursements described in subsection (g)(4)(A), or as 
a source of reserve and security for leveraged loans, the 
proceeds of which are deposited in the Loan Fund established 
under subsection (c). Loans under this section may be used by a 
health care provider to--
            (1) facilitate the purchase of certified EHR 
        technology;
            (2) enhance the utilization of certified EHR 
        technology (which may include costs associated with 
        upgrading health information technology so that it 
        meets criteria necessary to be a certified EHR 
        technology);
            (3) train personnel in the use of such technology; 
        or
            (4) improve the secure electronic exchange of 
        health information.
    (f) Types of Assistance.--Except as otherwise limited by 
applicable State law, amounts deposited into a Loan Fund under 
this section may only be used for the following:
            (1) To award loans that comply with the following:
                    (A) The interest rate for each loan shall 
                not exceed the market interest rate.
                    (B) The principal and interest payments on 
                each loan shall commence not later than 1 year 
                after the date the loan was awarded, and each 
                loan shall be fully amortized not later than 10 
                years after the date of the loan.
                    (C) The Loan Fund shall be credited with 
                all payments of principal and interest on each 
                loan awarded from the Loan Fund.
            (2) To guarantee, or purchase insurance for, a 
        local obligation (all of the proceeds of which finance 
        a project eligible for assistance under this 
        subsection) if the guarantee or purchase would improve 
        credit market access or reduce the interest rate 
        applicable to the obligation involved.
            (3) As a source of revenue or security for the 
        payment of principal and interest on revenue or general 
        obligation bonds issued by the eligible entity if the 
        proceeds of the sale of the bonds will be deposited 
        into the Loan Fund.
            (4) To earn interest on the amounts deposited into 
        the Loan Fund.
            (5) To make reimbursements described in subsection 
        (g)(4)(A).
    (g) Administration of Loan Funds.--
            (1) Combined financial administration.--An eligible 
        entity may (as a convenience and to avoid unnecessary 
        administrative costs) combine, in accordance with 
        applicable State law, the financial administration of a 
        Loan Fund established under this subsection with the 
        financial administration of any other revolving fund 
        established by the entity if otherwise not prohibited 
        by the law under which the Loan Fund was established.
            (2) Cost of administering fund.--Each eligible 
        entity may annually use not to exceed 4 percent of the 
        funds provided to the entity under a grant under this 
        section to pay the reasonable costs of the 
        administration of the programs under this section, 
        including the recovery of reasonable costs expended to 
        establish a Loan Fund which are incurred after the date 
        of the enactment of this title.
            (3) Guidance and regulations.--The National 
        Coordinator shall publish guidance and promulgate 
        regulations as may be necessary to carry out the 
        provisions of this section, including--
                    (A) provisions to ensure that each eligible 
                entity commits and expends funds allotted to 
                the entity under this section as efficiently as 
                possible in accordance with this title and 
                applicable State laws; and
                    (B) guidance to prevent waste, fraud, and 
                abuse.
            (4) Private sector contributions.--
                    (A) In general.--A Loan Fund established 
                under this section may accept contributions 
                from private sector entities, except that such 
                entities may not specify the recipient or 
                recipients of any loan issued under this 
                subsection. An eligible entity may agree to 
                reimburse a private sector entity for any 
                contribution made under this subparagraph, 
                except that the amount of such reimbursement 
                may not be greater than the principal amount of 
                the contribution made.
                    (B) Availability of information.--An 
                eligible entity shall make publicly available 
                the identity of, and amount contributed by, any 
                private sector entity under subparagraph (A) 
                and may issue letters of commendation or make 
                other awards (that have no financial value) to 
                any such entity.
    (h) Matching Requirements.--
            (1) In general.--The National Coordinator may not 
        make a grant under subsection (a) to an eligible entity 
        unless the entity agrees to make available (directly or 
        through donations from public or private entities) non-
        Federal contributions in cash to the costs of carrying 
        out the activities for which the grant is awarded in an 
        amount equal to not less than $1 for each $5 of Federal 
        funds provided under the grant.
            (2) Determination of amount of non-federal 
        contribution.--In determining the amount of non-Federal 
        contributions that an eligible entity has provided 
        pursuant to subparagraph (A), the National Coordinator 
        may not include any amounts provided to the entity by 
        the Federal Government.
    (i) Effective Date.--The Secretary may not make an award 
under this section prior to January 1, 2010.

SEC. 3015. [300JJ-35] DEMONSTRATION PROGRAM TO INTEGRATE INFORMATION 
                    TECHNOLOGY INTO CLINICAL EDUCATION.

    (a) In General.--The Secretary may award grants under this 
section to carry out demonstration projects to develop academic 
curricula integrating certified EHR technology in the clinical 
education of health professionals. Such awards shall be made on 
a competitive basis and pursuant to peer review.
    (b) Eligibility.--To be eligible to receive a grant under 
subsection (a), an entity shall--
            (1) submit to the Secretary an application at such 
        time, in such manner, and containing such information 
        as the Secretary may require;
            (2) submit to the Secretary a strategic plan for 
        integrating certified EHR technology in the clinical 
        education of health professionals to reduce medical 
        errors, increase access to prevention, reduce chronic 
        diseases, and enhance health care quality;
            (3) be--
                    (A) a school of medicine, osteopathic 
                medicine, dentistry, or pharmacy, a graduate 
                program in behavioral or mental health, or any 
                other graduate health professions school;
                    (B) a graduate school of nursing or 
                physician assistant studies;
                    (C) a consortium of two or more schools 
                described in subparagraph (A) or (B); or
                    (D) an institution with a graduate medical 
                education program in medicine, osteopathic 
                medicine, dentistry, pharmacy, nursing, or 
                physician assistance studies;
            (4) provide for the collection of data regarding 
        the effectiveness of the demonstration project to be 
        funded under the grant in improving the safety of 
        patients, the efficiency of health care delivery, and 
        in increasing the likelihood that graduates of the 
        grantee will adopt and incorporate certified EHR 
        technology, in the delivery of health care services; 
        and
            (5) provide matching funds in accordance with 
        subsection (d).
    (c) Use of Funds.--
            (1) In general.--With respect to a grant under 
        subsection (a), an eligible entity shall--
                    (A) use grant funds in collaboration with 2 
                or more disciplines; and
                    (B) use grant funds to integrate certified 
                EHR technology into community-based clinical 
                education.
            (2) Limitation.--An eligible entity shall not use 
        amounts received under a grant under subsection (a) to 
        purchase hardware, software, or services.
    (d) Financial Support.--The Secretary may not provide more 
than 50 percent of the costs of any activity for which 
assistance is provided under subsection (a), except in an 
instance of national economic conditions which would render the 
cost-share requirement under this subsection detrimental to the 
program and upon notification to Congress as to the 
justification to waive the cost-share requirement.
    (e) Evaluation.--The Secretary shall take such action as 
may be necessary to evaluate the projects funded under this 
section and publish, make available, and disseminate the 
results of such evaluations on as wide a basis as is 
practicable.
    (f) Reports.--Not later than 1 year after the date of 
enactment of this title, and annually thereafter, the Secretary 
shall submit to the Committee on Health, Education, Labor, and 
Pensions and the Committee on Finance of the Senate, and the 
Committee on Energy and Commerce of the House of 
Representatives a report that--
            (1) describes the specific projects established 
        under this section; and
            (2) contains recommendations for Congress based on 
        the evaluation conducted under subsection (e).

SEC. 3016. [300JJ-36] INFORMATION TECHNOLOGY PROFESSIONALS IN HEALTH 
                    CARE.

    (a) In General.--The Secretary, in consultation with the 
Director of the National Science Foundation, shall provide 
assistance to institutions of higher education (or consortia 
thereof) to establish or expand medical health informatics 
education programs, including certification, undergraduate, and 
masters degree programs, for both health care and information 
technology students to ensure the rapid and effective 
utilization and development of health information technologies 
(in the United States health care infrastructure).
    (b) Activities.--Activities for which assistance may be 
provided under subsection (a) may include the following:
            (1) Developing and revising curricula in medical 
        health informatics and related disciplines.
            (2) Recruiting and retaining students to the 
        program involved.
            (3) Acquiring equipment necessary for student 
        instruction in these programs, including the 
        installation of testbed networks for student use.
            (4) Establishing or enhancing bridge programs in 
        the health informatics fields between community 
        colleges and universities.
    (c) Priority.--In providing assistance under subsection 
(a), the Secretary shall give preference to the following:
            (1) Existing education and training programs.
            (2) Programs designed to be completed in less than 
        six months.

SEC. 3017. [300JJ-37] GENERAL GRANT AND LOAN PROVISIONS.

    (a) Reports.--The Secretary may require that an entity 
receiving assistance under this subtitle shall submit to the 
Secretary, not later than the date that is 1 year after the 
date of receipt of such assistance, a report that includes--
            (1) an analysis of the effectiveness of the 
        activities for which the entity receives such 
        assistance, as compared to the goals for such 
        activities; and
            (2) an analysis of the impact of the project on 
        health care quality and safety.
    (b) Requirement to Improve Quality of Care and Decrease in 
Costs.--The National Coordinator shall annually evaluate the 
activities conducted under this subtitle and shall, in awarding 
grants, implement the lessons learned from such evaluation in a 
manner so that awards made subsequent to each such evaluation 
are made in a manner that, in the determination of the National 
Coordinator, will result in the greatest improvement in the 
quality and efficiency of health care.

SEC. 3018. [300JJ-38] AUTHORIZATION FOR APPROPRIATIONS.

    For the purposes of carrying out this subtitle, there is 
authorized to be appropriated such sums as may be necessary for 
each of the fiscal years 2009 through 2013.

                      Subtitle C--Other Provisions

SEC. 3021. [300JJ-51] HEALTH INFORMATION TECHNOLOGY ENROLLMENT 
                    STANDARDS AND PROTOCOLS.

    (a) In General.--
            (1) Standards and protocols.--Not later than 180 
        days after the date of enactment of this title, the 
        Secretary, in consultation with the HIT Policy 
        Committee and the HIT Standards Committee, shall 
        develop interoperable and secure standards and 
        protocols that facilitate enrollment of individuals in 
        Federal and State health and human services programs, 
        as determined by the Secretary.
            (2) Methods.--The Secretary shall facilitate 
        enrollment in such programs through methods determined 
        appropriate by the Secretary, which shall include 
        providing individuals and third parties authorized by 
        such individuals and their designees notification of 
        eligibility and verification of eligibility required 
        under such programs.
    (b) Content.--The standards and protocols for electronic 
enrollment in the Federal and State programs described in 
subsection (a) shall allow for the following:
            (1) Electronic matching against existing Federal 
        and State data, including vital records, employment 
        history, enrollment systems, tax records, and other 
        data determined appropriate by the Secretary to serve 
        as evidence of eligibility and in lieu of paper-based 
        documentation.
            (2) Simplification and submission of electronic 
        documentation, digitization of documents, and systems 
        verification of eligibility.
            (3) Reuse of stored eligibility information 
        (including documentation) to assist with retention of 
        eligible individuals.
            (4) Capability for individuals to apply, recertify 
        and manage their eligibility information online, 
        including at home, at points of service, and other 
        community-based locations.
            (5) Ability to expand the enrollment system to 
        integrate new programs, rules, and functionalities, to 
        operate at increased volume, and to apply streamlined 
        verification and eligibility processes to other Federal 
        and State programs, as appropriate.
            (6) Notification of eligibility, recertification, 
        and other needed communication regarding eligibility, 
        which may include communication via email and cellular 
        phones.
            (7) Other functionalities necessary to provide 
        eligibles with streamlined enrollment process.
    (c) Approval and Notification.--With respect to any 
standard or protocol developed under subsection (a) that has 
been approved by the HIT Policy Committee and the HIT Standards 
Committee, the Secretary--
            (1) shall notify States of such standards or 
        protocols; and
            (2) may require, as a condition of receiving 
        Federal funds for the health information technology 
        investments, that States or other entities incorporate 
        such standards and protocols into such investments.
    (d) Grants for Implementation of Appropriate Enrollment 
HIT.--
            (1) In general.--The Secretary shall award grant to 
        eligible entities to develop new, and adapt existing, 
        technology systems to implement the HIT enrollment 
        standards and protocols developed under subsection (a) 
        (referred to in this subsection as ``appropriate HIT 
        technology'').
            (2) Eligible entities.--To be eligible for a grant 
        under this subsection, an entity shall--
                    (A) be a State, political subdivision of a 
                State, or a local governmental entity; and
                    (B) submit to the Secretary an application 
                at such time, in such manner, and containing--
                            (i) a plan to adopt and implement 
                        appropriate enrollment technology that 
                        includes--
                                    (I) proposed reduction in 
                                maintenance costs of technology 
                                systems;
                                    (II) elimination or 
                                updating of legacy systems; and
                                    (III) demonstrated 
                                collaboration with other 
                                entities that may receive a 
                                grant under this section that 
                                are located in the same State, 
                                political subdivision, or 
                                locality;
                            (ii) an assurance that the entity 
                        will share such appropriate enrollment 
                        technology in accordance with paragraph 
                        (4); and
                            (iii) such other information as the 
                        Secretary may require.
            (3) Sharing.--
                    (A) In general.--The Secretary shall ensure 
                that appropriate enrollment HIT adopted under 
                grants under this subsection is made available 
                to other qualified State, qualified political 
                subdivisions of a State, or other appropriate 
                qualified entities (as described in 
                subparagraph (B)) at no cost.
                    (B) Qualified entities.--The Secretary 
                shall determine what entities are qualified to 
                receive enrollment HIT under subparagraph (A), 
                taking into consideration the recommendations 
                of the HIT Policy Committee and the HIT 
                Standards Committee.
           TITLE XXXI--DATA COLLECTION, ANALYSIS, AND QUALITY

SEC. 3101. [300KK] DATA COLLECTION, ANALYSIS, AND QUALITY.

    (a) Data Collection.--
            (1) In general.--The Secretary shall ensure that, 
        by not later than 2 years after the date of enactment 
        of this title, any federally conducted or supported 
        health care or public health program, activity or 
        survey (including Current Population Surveys and 
        American Community Surveys conducted by the Bureau of 
        Labor Statistics and the Bureau of the Census) collects 
        and reports, to the extent practicable--
                    (A) data on race, ethnicity, sex, primary 
                language, and disability status for applicants, 
                recipients, or participants;
                    (B) data at the smallest geographic level 
                such as State, local, or institutional levels 
                if such data can be aggregated;
                    (C) sufficient data to generate 
                statistically reliable estimates by racial, 
                ethnic, sex, primary language, and disability 
                status subgroups for applicants, recipients or 
                participants using, if needed, statistical 
                oversamples of these subpopulations; and
                    (D) any other demographic data as deemed 
                appropriate by the Secretary regarding health 
                disparities.
            (2) Collection standards.--In collecting data 
        described in paragraph (1), the Secretary or designee 
        shall--
                    (A) use Office of Management and Budget 
                standards, at a minimum, for race and ethnicity 
                measures;
                    (B) develop standards for the measurement 
                of sex, primary language, and disability 
                status;
                    (C) develop standards for the collection of 
                data described in paragraph (1) that, at a 
                minimum--
                            (i) collects self-reported data by 
                        the applicant, recipient, or 
                        participant; and
                            (ii) collects data from a parent or 
                        legal guardian if the applicant, 
                        recipient, or participant is a minor or 
                        legally incapacitated;
                    (D) survey health care providers and 
                establish other procedures in order to assess 
                access to care and treatment for individuals 
                with disabilities and to identify--
                            (i) locations where individuals 
                        with disabilities access primary, acute 
                        (including intensive), and long-term 
                        care;
                            (ii) the number of providers with 
                        accessible facilities and equipment to 
                        meet the needs of the individuals with 
                        disabilities, including medical 
                        diagnostic equipment that meets the 
                        minimum technical criteria set forth in 
                        section 510 of the Rehabilitation Act 
                        of 1973; and
                            (iii) the number of employees of 
                        health care providers trained in 
                        disability awareness and patient care 
                        of individuals with disabilities; and
                    (E) require that any reporting requirement 
                imposed for purposes of measuring quality under 
                any ongoing or federally conducted or supported 
                health care or public health program, activity, 
                or survey includes requirements for the 
                collection of data on individuals receiving 
                health care items or services under such 
                programs activities by race, ethnicity, sex, 
                primary language, and disability status.
            (3) Data management.--In collecting data described 
        in paragraph (1), the Secretary, acting through the 
        National Coordinator for Health Information Technology 
        shall--
                    (A) develop national standards for the 
                management of data collected; and
                    (B) develop interoperability and security 
                systems for data management.
    (b) \1\ Data Analysis.--
---------------------------------------------------------------------------
    \1\ So in law. Subsection (b) includes a paragraph (1) but there 
are no subsequent paragraphs.
---------------------------------------------------------------------------
            (1) In general.--For each federally conducted or 
        supported health care or public health program or 
        activity, the Secretary shall analyze data collected 
        under paragraph (a) to detect and monitor trends in 
        health disparities (as defined for purposes of section 
        485E) at the Federal and State levels.
    (c) Data Reporting and Dissemination.--
            (1) In general.--The Secretary shall make the 
        analyses described in (b) available to--
                    (A) the Office of Minority Health;
                    (B) the National Center on Minority Health 
                and Health Disparities;
                    (C) the Agency for Healthcare Research and 
                Quality;
                    (D) the Centers for Disease Control and 
                Prevention;
                    (E) the Centers for Medicare & Medicaid 
                Services;
                    (F) the Indian Health Service and 
                epidemiology centers funded under the Indian 
                Health Care Improvement Act;
                    (G) the Office of Rural health;
                    (H) other agencies within the Department of 
                Health and Human Services; and
                    (I) other entities as determined 
                appropriate by the Secretary.
            (2) Reporting of data.--The Secretary shall report 
        data and analyses described in (a) and (b) through--
                    (A) public postings on the Internet 
                websites of the Department of Health and Human 
                Services; and
                    (B) any other reporting or dissemination 
                mechanisms determined appropriate by the 
                Secretary.
            (3) Availability of data.--The Secretary may make 
        data described in (a) and (b) available for additional 
        research, analyses, and dissemination to other Federal 
        agencies, non-governmental entities, and the public, in 
        accordance with any Federal agency's data user 
        agreements.
    (d) Limitations on Use of Data.--Nothing in this section 
shall be construed to permit the use of information collected 
under this section in a manner that would adversely affect any 
individual.
    (e) Protection and Sharing of Data.--
            (1) Privacy and other safeguards.--The Secretary 
        shall ensure (through the promulgation of regulations 
        or otherwise) that--
                    (A) all data collected pursuant to 
                subsection (a) is protected--
                            (i) under privacy protections that 
                        are at least as broad as those that the 
                        Secretary applies to other health data 
                        under the regulations promulgated under 
                        section 264(c) of the Health Insurance 
                        Portability and Accountability Act of 
                        1996 (Public Law 104-191; 110 Stat. 
                        2033); and
                            (ii) from all inappropriate 
                        internal use by any entity that 
                        collects, stores, or receives the data, 
                        including use of such data in 
                        determinations of eligibility (or 
                        continued eligibility) in health plans, 
                        and from other inappropriate uses, as 
                        defined by the Secretary; and
                    (B) all appropriate information security 
                safeguards are used in the collection, 
                analysis, and sharing of data collected 
                pursuant to subsection (a).
            (2) Data sharing.--The Secretary shall establish 
        procedures for sharing data collected pursuant to 
        subsection (a), measures relating to such data, and 
        analyses of such data, with other relevant Federal and 
        State agencies including the agencies, centers, and 
        entities within the Department of Health and Human 
        Services specified in subsection (c)(1)..
    (f) Data on Rural Underserved Populations.--The Secretary 
shall ensure that any data collected in accordance with this 
section regarding racial and ethnic minority groups are also 
collected regarding underserved rural and frontier populations.
    (g) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of fiscal 
years 2010 through 2014.
    (h) Requirement for Implementation.--Notwithstanding any 
other provision of this section, data may not be collected 
under this section unless funds are directly appropriated for 
such purpose in an appropriations Act.
    (i) Consultation.--The Secretary shall consult with the 
Director of the Office of Personnel Management, the Secretary 
of Defense, the Secretary of Veterans Affairs, the Director of 
the Bureau of the Census, the Commissioner of Social Security, 
and the head of other appropriate Federal agencies in carrying 
out this section.
======================================================================


     TITLE XXXII--COMMUNITY LIVING ASSISTANCE SERVICES AND SUPPORTS

    [Note: Effective January 1, 2011, section 8002(a)(1) of 
Public Law 111-148 provides for an amendment to add at the end 
of the Public Health Service Act a new title XXXII as follows:]

SEC. 3201. [300LL] PURPOSE.

    The purpose of this title is to establish a national 
voluntary insurance program for purchasing community living 
assistance services and supports in order to--
            (1) provide individuals with functional limitations 
        with tools that will allow them to maintain their 
        personal and financial independence and live in the 
        community through a new financing strategy for 
        community living assistance services and supports;
            (2) establish an infrastructure that will help 
        address the Nation's community living assistance 
        services and supports needs;
            (3) alleviate burdens on family caregivers; and
            (4) address institutional bias by providing a 
        financing mechanism that supports personal choice and 
        independence to live in the community.

SEC. 3202. [300LL-1] DEFINITIONS.

    In this title:
            (1) Active enrollee.--The term ``active enrollee'' 
        means an individual who is enrolled in the CLASS 
        program in accordance with section 3204 and who has 
        paid any premiums due to maintain such enrollment.
            (2) Actively employed.--The term ``actively 
        employed'' means an individual who--
                    (A) is reporting for work at the 
                individual's usual place of employment or at 
                another location to which the individual is 
                required to travel because of the individual's 
                employment (or in the case of an individual who 
                is a member of the uniformed services, is on 
                active duty and is physically able to perform 
                the duties of the individual's position); and
                    (B) is able to perform all the usual and 
                customary duties of the individual's employment 
                on the individual's regular work schedule.
            (3) Activities of daily living.--The term 
        ``activities of daily living'' means each of the 
        following activities specified in section 
        7702B(c)(2)(B) of the Internal Revenue Code of 1986:
                    (A) Eating.
                    (B) Toileting.
                    (C) Transferring.
                    (D) Bathing.
                    (E) Dressing.
                    (F) Continence.
            (4) CLASS program.--The term ``CLASS program'' 
        means the program established under this title.
            (5) Eligibility assessment system.--The term 
        ``Eligibility Assessment System'' means the entity 
        established by the Secretary under section 3205(a)(2) 
        to make functional eligibility determinations for the 
        CLASS program.
            (6) Eligible beneficiary.--
                    (A) In general.--The term ``eligible 
                beneficiary'' means any individual who is an 
                active enrollee in the CLASS program and, as of 
                the date described in subparagraph (B)--
                            (i) has paid premiums for 
                        enrollment in such program for at least 
                        60 months;
                            (ii) has earned, with respect to at 
                        least 3 calendar years that occur 
                        during the first 60 months for which 
                        the individual has paid premiums for 
                        enrollment in the program, at least an 
                        amount equal to the amount of wages and 
                        self-employment income which an 
                        individual must have in order to be 
                        credited with a quarter of coverage 
                        under section 213(d) of the Social 
                        Security Act for the year; and
                            (iii) has paid premiums for 
                        enrollment in such program for at least 
                        24 consecutive months, if a lapse in 
                        premium payments of more than 3 months 
                        has occurred during the period that 
                        begins on the date of the individual's 
                        enrollment and ends on the date of such 
                        determination.
                    (B) Date described.--For purposes of 
                subparagraph (A), the date described in this 
                subparagraph is the date on which the 
                individual is determined to have a functional 
                limitation described in section 3203(a)(1)(C) 
                that is expected to last for a continuous 
                period of more than 90 days.
                    (C) Regulations.--The Secretary shall 
                promulgate regulations specifying exceptions to 
                the minimum earnings requirements under 
                subparagraph (A)(ii) for purposes of being 
                considered an eligible beneficiary for certain 
                populations.
            (7) Hospital; nursing facility; intermediate care 
        facility for the mentally retarded; institution for 
        mental diseases.--The terms ``hospital'', ``nursing 
        facility'', ``intermediate care facility for the 
        mentally retarded'', and ``institution for mental 
        diseases'' have the meanings given such terms for 
        purposes of Medicaid.
            (8) CLASS independence advisory council.--The term 
        ``CLASS Independence Advisory Council'' or ``Council'' 
        means the Advisory Council established under section 
        3207 to advise the Secretary.
            (9) CLASS independence benefit plan.--The term 
        ``CLASS Independence Benefit Plan'' means the benefit 
        plan developed and designated by the Secretary in 
        accordance with section 3203.
            (10) CLASS independence fund.--The term ``CLASS 
        Independence Fund'' or ``Fund'' means the fund 
        established under section 3206.
            (11) Medicaid.--The term ``Medicaid'' means the 
        program established under title XIX of the Social 
        Security Act (42 U.S.C. 1396 et seq.).
            (12) Poverty line.--The term ``poverty line'' has 
        the meaning given that term in section 2110(c)(5) of 
        the Social Security Act (42 U.S.C. 1397jj(c)(5)).
            (13) Protection and advocacy system.--The term 
        ``Protection and Advocacy System'' means the system for 
        each State established under section 143 of the 
        Developmental Disabilities Assistance and Bill of 
        Rights Act of 2000 (42 U.S.C. 15043).

SEC. 3203. [300LL-2] CLASS INDEPENDENCE BENEFIT PLAN.

    (a) Process for Development.--
            (1) In general.--The Secretary, in consultation 
        with appropriate actuaries and other experts, shall 
        develop at least 3 actuarially sound benefit plans as 
        alternatives for consideration for designation by the 
        Secretary as the CLASS Independence Benefit Plan under 
        which eligible beneficiaries shall receive benefits 
        under this title. Each of the plan alternatives 
        developed shall be designed to provide eligible 
        beneficiaries with the benefits described in section 
        3205 consistent with the following requirements:
                    (A) Premiums.--
                            (i) In general.--Beginning with the 
                        first year of the CLASS program, and 
                        for each year thereafter, subject to 
                        clauses (ii) and (iii), the Secretary 
                        shall establish all premiums to be paid 
                        by enrollees for the year based on an 
                        actuarial analysis of the 75-year costs 
                        of the program that ensures solvency 
                        throughout such 75-year period.
                            (ii) Nominal premium for poorest 
                        individuals and full-time students.--
                                    (I) In general.--The 
                                monthly premium for enrollment 
                                in the CLASS program shall not 
                                exceed the applicable dollar 
                                amount per month determined 
                                under subclause (II) for--
                                            (aa) any individual 
                                        whose income does not 
                                        exceed the poverty 
                                        line; and
                                            (bb) any individual 
                                        who has not attained 
                                        age 22, and is actively 
                                        employed during any 
                                        period in which the 
                                        individual is a full-
                                        time student (as 
                                        determined by the 
                                        Secretary).
                                    (II) Applicable dollar 
                                amount.--The applicable dollar 
                                amount described in this 
                                subclause is the amount equal 
                                to $5, increased by the 
                                percentage increase in the 
                                consumer price index for all 
                                urban consumers (U.S. city 
                                average) for each year 
                                occurring after 2009 and before 
                                such year.
                            (iii) Class independence fund 
                        reserves.--At such time as the CLASS 
                        program has been in operation for 10 
                        years, the Secretary shall establish 
                        all premiums to be paid by enrollees 
                        for the year based on an actuarial 
                        analysis that accumulated reserves in 
                        the CLASS Independence Fund would not 
                        decrease in that year. At such time as 
                        the Secretary determines the CLASS 
                        program demonstrates a sustained 
                        ability to finance expected yearly 
                        expenses with expected yearly premiums 
                        and interest credited to the CLASS 
                        Independence Fund, the Secretary may 
                        decrease the required amount of CLASS 
                        Independence Fund reserves.
                    (B) Vesting period.--A 5-year vesting 
                period for eligibility for benefits.
                    (C) Benefit triggers.--A benefit trigger 
                for provision of benefits that requires a 
                determination that an individual has a 
                functional limitation, as certified by a 
                licensed health care practitioner, described in 
                any of the following clauses that is expected 
                to last for a continuous period of more than 90 
                days:
                            (i) The individual is determined to 
                        be unable to perform at least the 
                        minimum number (which may be 2 or 3) of 
                        activities of daily living as are 
                        required under the plan for the 
                        provision of benefits without 
                        substantial assistance (as defined by 
                        the Secretary) from another individual.
                            (ii) The individual requires 
                        substantial supervision to protect the 
                        individual from threats to health and 
                        safety due to substantial cognitive 
                        impairment.
                            (iii) The individual has a level of 
                        functional limitation similar (as 
                        determined under regulations prescribed 
                        by the Secretary) to the level of 
                        functional limitation described in 
                        clause (i) or (ii).
                    (D) Cash benefit.--Payment of a cash 
                benefit that satisfies the following 
                requirements:
                            (i) Minimum required amount.--The 
                        benefit amount provides an eligible 
                        beneficiary with not less than an 
                        average of $50 per day (as determined 
                        based on the reasonably expected 
                        distribution of beneficiaries receiving 
                        benefits at various benefit levels).
                            (ii) Amount scaled to functional 
                        ability.--The benefit amount is varied 
                        based on a scale of functional ability, 
                        with not less than 2, and not more than 
                        6, benefit level amounts.
                            (iii) Daily or weekly.--The benefit 
                        is paid on a daily or weekly basis.
                            (iv) No lifetime or aggregate 
                        limit.--The benefit is not subject to 
                        any lifetime or aggregate limit.
            (2) Review and recommendation by the class 
        independence advisory council.--The CLASS Independence 
        Advisory Council shall--
                    (A) evaluate the alternative benefit plans 
                developed under paragraph (1); and
                    (B) recommend for designation as the CLASS 
                Independence Benefit Plan for offering to the 
                public the plan that the Council determines 
                best balances price and benefits to meet 
                enrollees' needs in an actuarially sound 
                manner, while optimizing the probability of the 
                long-term sustainability of the CLASS program.
            (3) Designation by the secretary.--Not later than 
        October 1, 2012, the Secretary, taking into 
        consideration the recommendation of the CLASS 
        Independence Advisory Council under paragraph (2)(B), 
        shall designate a benefit plan as the CLASS 
        Independence Benefit Plan. The Secretary shall publish 
        such designation, along with details of the plan and 
        the reasons for the selection by the Secretary, in a 
        final rule that allows for a period of public comment.
    (b) Additional Premium Requirements.--
            (1) Adjustment of premiums.--
                    (A) In general.--Except as provided in 
                subparagraphs (B), (C), (D), and (E), the 
                amount of the monthly premium determined for an 
                individual upon such individual's enrollment in 
                the CLASS program shall remain the same for as 
                long as the individual is an active enrollee in 
                the program.
                    (B) Recalculated premium if required for 
                program solvency.--
                            (i) In general.--Subject to clause 
                        (ii), if the Secretary determines, 
                        based on the most recent report of the 
                        Board of Trustees of the CLASS 
                        Independence Fund, the advice of the 
                        CLASS Independence Advisory Council, 
                        and the annual report of the Inspector 
                        General of the Department of Health and 
                        Human Services, and waste, fraud, and 
                        abuse, or such other information as the 
                        Secretary determines appropriate, that 
                        the monthly premiums and income to the 
                        CLASS Independence Fund for a year are 
                        projected to be insufficient with 
                        respect to the 20-year period that 
                        begins with that year, the Secretary 
                        shall adjust the monthly premiums for 
                        individuals enrolled in the CLASS 
                        program as necessary (but maintaining a 
                        nominal premium for enrollees whose 
                        income is below the poverty line or who 
                        are full-time students actively 
                        employed).
                            (ii) Exemption from increase.--Any 
                        increase in a monthly premium imposed 
                        as result of a determination described 
                        in clause (i) shall not apply with 
                        respect to the monthly premium of any 
                        active enrollee who--
                                    (I) has attained age 65;
                                    (II) has paid premiums for 
                                enrollment in the program for 
                                at least 20 years; and
                                    (III) is not actively 
                                employed.
                    (C) Recalculated premium if reenrollment 
                after more than a 3-month lapse.--
                            (i) In general.--The reenrollment 
                        of an individual after a 90-day period 
                        during which the individual failed to 
                        pay the monthly premium required to 
                        maintain the individual's enrollment in 
                        the CLASS program shall be treated as 
                        an initial enrollment for purposes of 
                        age-adjusting the premium for 
                        reenrollment in the program.
                            (ii) Credit for prior months if 
                        reenrolled within 5 years.--An 
                        individual who reenrolls in the CLASS 
                        program after such a 90-day period and 
                        before the end of the 5-year period 
                        that begins with the first month for 
                        which the individual failed to pay the 
                        monthly premium required to maintain 
                        the individual's enrollment in the 
                        program shall be--
                                    (I) credited with any 
                                months of paid premiums that 
                                accrued prior to the 
                                individual's lapse in 
                                enrollment; and
                                    (II) notwithstanding the 
                                total amount of any such 
                                credited months, required to 
                                satisfy section 3202(6)(A)(ii) 
                                before being eligible to 
                                receive benefits.
                    (D) No longer status as a full-time 
                student.--An individual subject to a nominal 
                premium on the basis of being described in 
                subsection (a)(1)(A)(ii)(I)(bb) who ceases to 
                be described in that subsection, beginning with 
                the first month following the month in which 
                the individual ceases to be so described, shall 
                be subject to the same monthly premium as the 
                monthly premium that applies to an individual 
                of the same age who first enrolls in the 
                program under the most similar circumstances as 
                the individual (such as the first year of 
                eligibility for enrollment in the program or in 
                a subsequent year).
                    (E) Penalty for reenollment after 5-year 
                lapse.--In the case of an individual who 
                reenrolls in the CLASS program after the end of 
                the 5-year period described in subparagraph 
                (C)(ii), the monthly premium required for the 
                individual shall be the age-adjusted premium 
                that would be applicable to an initially 
                enrolling individual who is the same age as the 
                reenrolling individual, increased by the 
                greater of--
                            (i) an amount that the Secretary 
                        determines is actuarially sound for 
                        each month that occurs during the 
                        period that begins with the first month 
                        for which the individual failed to pay 
                        the monthly premium required to 
                        maintain the individual's enrollment in 
                        the CLASS program and ends with the 
                        month preceding the month in which the 
                        reenollment is effective; or
                            (ii) 1 percent of the applicable 
                        age-adjusted premium for each such 
                        month occurring in such period.
            (2) Administrative expenses.--In determining the 
        monthly premiums for the CLASS program the Secretary 
        may factor in costs for administering the program, not 
        to exceed for any year in which the program is in 
        effect under this title, an amount equal to 3 percent 
        of all premiums paid during the year.
            (3) No underwriting requirements.--No underwriting 
        (other than on the basis of age in accordance with 
        subparagraphs (D) and (E) of paragraph (1)) shall be 
        used to--
                    (A) determine the monthly premium for 
                enrollment in the CLASS program; or
                    (B) prevent an individual from enrolling in 
                the program.
    (c) Self-attestation and Verification of Income.--The 
Secretary shall establish procedures to--
            (1) permit an individual who is eligible for the 
        nominal premium required under subsection (a)(1)(A)(ii) 
        to self-attest that their income does not exceed the 
        poverty line or that their status as a full-time 
        student who is actively employed;
            (2) verify, using procedures similar to the 
        procedures used by the Commissioner of Social Security 
        under section 1631(e)(1)(B)(ii) of the Social Security 
        Act and consistent with the requirements applicable to 
        the conveyance of data and information under section 
        1942 of such Act, the validity of such self-
        attestation; and
            (3) require an individual to confirm, on at least 
        an annual basis, that their income does not exceed the 
        poverty line or that they continue to maintain such 
        status.

SEC. 3204. [300LL-3] ENROLLMENT AND DISENROLLMENT REQUIREMENTS.

    (a) Automatic Enrollment.--
            (1) In general.--Subject to paragraph (2), the 
        Secretary, in coordination with the Secretary of the 
        Treasury, shall establish procedures under which each 
        individual described in subsection (c) may be 
        automatically enrolled in the CLASS program by an 
        employer of such individual in the same manner as an 
        employer may elect to automatically enroll employees in 
        a plan under section 401(k), 403(b), or 457 of the 
        Internal Revenue Code of 1986.
            (2) Alternative enrollment procedures.--The 
        procedures established under paragraph (1) shall 
        provide for an alternative enrollment process for an 
        individual described in subsection (c) in the case of 
        such an individual--
                    (A) who is self-employed;
                    (B) who has more than 1 employer; or
                    (C) whose employer does not elect to 
                participate in the automatic enrollment process 
                established by the Secretary.
            (3) Administration.--
                    (A) In general.--The Secretary and the 
                Secretary of the Treasury shall, by regulation, 
                establish procedures to ensure that an 
                individual is not automatically enrolled in the 
                CLASS program by more than 1 employer.
                    (B) Form.--Enrollment in the CLASS program 
                shall be made in such manner as the Secretary 
                may prescribe in order to ensure ease of 
                administration.
    (b) Election to Opt-Out.--An individual described in 
subsection (c) may elect to waive enrollment in the CLASS 
program at any time in such form and manner as the Secretary 
and the Secretary of the Treasury shall prescribe.
    (c) Individual Described.--For purposes of enrolling in the 
CLASS program, an individual described in this paragraph is an 
individual--
            (1) who has attained age 18;
            (2) who--
                    (A) receives wages or income on which there 
                is imposed a tax under section 3101(a) or 
                3201(a) of the Internal Revenue Code of 1986; 
                or
                    (B) derives self-employment income on which 
                there is imposed a tax under section 1401(a) of 
                the Internal Revenue Code of 1986;
            (3) who is actively employed; and
            (4) who is not--
                    (A) a patient in a hospital or nursing 
                facility, an intermediate care facility for the 
                mentally retarded, or an institution for mental 
                diseases and receiving medical assistance under 
                Medicaid; or
                    (B) confined in a jail, prison, other penal 
                institution or correctional facility, or by 
                court order pursuant to conviction of a 
                criminal offense or in connection with a 
                verdict or finding described in section 
                202(x)(1)(A)(ii) of the Social Security Act (42 
                U.S.C. 402(x)(1)(A)(ii)).
    (d) Rule of Construction.--Nothing in this title shall be 
construed as requiring an active enrollee to continue to 
satisfy subparagraph (A) or (B) of subsection (c)(2) in order 
to maintain enrollment in the CLASS program.
    (e) Payment.--
            (1) Payroll deduction.--An amount equal to the 
        monthly premium for the enrollment in the CLASS program 
        of an individual shall be deducted from the wages or 
        self-employment income of such individual in accordance 
        with such procedures as the Secretary, in coordination 
        with the Secretary of the Treasury, shall establish for 
        employers who elect to deduct and withhold such 
        premiums on behalf of enrolled employees.
            (2) Alternative payment mechanism.--The Secretary, 
        in coordination with the Secretary of the Treasury, 
        shall establish alternative procedures for the payment 
        of monthly premiums by an individual enrolled in the 
        CLASS program--
                    (A) who does not have an employer who 
                elects to deduct and withhold premiums in 
                accordance with paragraph (1); or
                    (B) who does not earn wages or derive self-
                employment income.
    (f) Transfer of Premiums Collected.--
            (1) In general.--During each calendar year the 
        Secretary of the Treasury shall deposit into the CLASS 
        Independence Fund a total amount equal, in the 
        aggregate, to 100 percent of the premiums collected 
        during that year.
            (2) Transfers based on estimates.--The amount 
        deposited pursuant to paragraph (1) shall be 
        transferred in at least monthly payments to the CLASS 
        Independence Fund on the basis of estimates by the 
        Secretary and certified to the Secretary of the 
        Treasury of the amounts collected in accordance with 
        subparagraphs (A) and (B) of paragraph (5). Proper 
        adjustments shall be made in amounts subsequently 
        transferred to the Fund to the extent prior estimates 
        were in excess of, or were less than, actual amounts 
        collected.
    (g) Other Enrollment and Disenrollment Opportunities.--The 
Secretary, in coordination with the Secretary of the Treasury, 
shall establish procedures under which--
            (1) an individual who, in the year of the 
        individual's initial eligibility to enroll in the CLASS 
        program, has not enrolled in the program, is eligible 
        to elect to enroll in the program, in such form and 
        manner as the Secretaries shall establish, only during 
        an open enrollment period established by the 
        Secretaries that is specific to the individual and that 
        may not occur more frequently than biennially after the 
        date on which the individual first elected to waive 
        enrollment in the program; and
            (2) an individual shall only be permitted to 
        disenroll from the program (other than for nonpayment 
        of premiums) during an annual disenrollment period 
        established by the Secretaries and in such form and 
        manner as the Secretaries shall establish.

SEC. 3205. [300LL-4] BENEFITS.

    (a) Determination of Eligibility.--
            (1) Application for receipt of benefits.--The 
        Secretary shall establish procedures under which an 
        active enrollee shall apply for receipt of benefits 
        under the CLASS Independence Benefit Plan.
            (2) Eligibility assessments.--
                    (A) In general.--Not later than January 1, 
                2012, the Secretary shall--
                            (i) establish an Eligibility 
                        Assessment System (other than a service 
                        with which the Commissioner of Social 
                        Security has entered into an agreement, 
                        with respect to any State, to make 
                        disability determinations for purposes 
                        of title II or XVI of the Social 
                        Security Act) to provide for 
                        eligibility assessments of active 
                        enrollees who apply for receipt of 
                        benefits;
                            (ii) enter into an agreement with 
                        the Protection and Advocacy System for 
                        each State to provide advocacy services 
                        in accordance with subsection (d); and
                            (iii) enter into an agreement with 
                        public and private entities to provide 
                        advice and assistance counseling in 
                        accordance with subsection (e).
                    (B) Regulations.--The Secretary shall 
                promulgate regulations to develop an expedited 
                nationally equitable eligibility determination 
                process, as certified by a licensed health care 
                practitioner, an appeals process, and a 
                redetermination process, as certified by a 
                licensed health care practitioner, including 
                whether an active enrollee is eligible for a 
                cash benefit under the program and if so, the 
                amount of the cash benefit (in accordance the 
                sliding scale established under the plan).
                    (C) Presumptive eligibility for certain 
                institutionalized enrollees planning to 
                discharge.--An active enrollee shall be deemed 
                presumptively eligible if the enrollee--
                            (i) has applied for, and attests is 
                        eligible for, the maximum cash benefit 
                        available under the sliding scale 
                        established under the CLASS 
                        Independence Benefit Plan;
                            (ii) is a patient in a hospital 
                        (but only if the hospitalization is for 
                        long-term care), nursing facility, 
                        intermediate care facility for the 
                        mentally retarded, or an institution 
                        for mental diseases; and
                            (iii) is in the process of, or 
                        about to begin the process of, planning 
                        to discharge from the hospital, 
                        facility, or institution, or within 60 
                        days from the date of discharge from 
                        the hospital, facility, or institution.
                    (D) Appeals.--The Secretary shall establish 
                procedures under which an applicant for 
                benefits under the CLASS Independence Benefit 
                Plan shall be guaranteed the right to appeal an 
                adverse determination.
    (b) Benefits.--An eligible beneficiary shall receive the 
following benefits under the CLASS Independence Benefit Plan:
            (1) Cash benefit.--A cash benefit established by 
        the Secretary in accordance with the requirements of 
        section 3203(a)(1)(D) that--
                    (A) the first year in which beneficiaries 
                receive the benefits under the plan, is not 
                less than the average dollar amount specified 
                in clause (i) of such section; and
                    (B) for any subsequent year, is not less 
                than the average per day dollar limit 
                applicable under this subparagraph for the 
                preceding year, increased by the percentage 
                increase in the consumer price index for all 
                urban consumers (U.S. city average) over the 
                previous year.
            (2) Advocacy services.--Advocacy services in 
        accordance with subsection (d).
            (3) Advice and assistance counseling.--Advice and 
        assistance counseling in accordance with subsection 
        (e).
            (4) Administrative expenses.--Advocacy services and 
        advise and assistance counseling services under 
        paragraphs (2) and (3) of this subsection shall be 
        included as administrative expenses under section 
        3203(b)(3).
    (c) Payment of Benefits.--
            (1) Life independence account.--
                    (A) In general.--The Secretary shall 
                establish procedures for administering the 
                provision of benefits to eligible beneficiaries 
                under the CLASS Independence Benefit Plan, 
                including the payment of the cash benefit for 
                the beneficiary into a Life Independence 
                Account established by the Secretary on behalf 
                of each eligible beneficiary.
                    (B) Use of cash benefits.--Cash benefits 
                paid into a Life Independence Account of an 
                eligible beneficiary shall be used to purchase 
                nonmedical services and supports that the 
                beneficiary needs to maintain his or her 
                independence at home or in another residential 
                setting of their choice in the community, 
                including (but not limited to) home 
                modifications, assistive technology, accessible 
                transportation, homemaker services, respite 
                care, personal assistance services, home care 
                aides, and nursing support. Nothing in the 
                preceding sentence shall prevent an eligible 
                beneficiary from using cash benefits paid into 
                a Life Independence Account for obtaining 
                assistance with decision making concerning 
                medical care, including the right to accept or 
                refuse medical or surgical treatment and the 
                right to formulate advance directives or other 
                written instructions recognized under State 
                law, such as a living will or durable power of 
                attorney for health care, in the case that an 
                injury or illness causes the individual to be 
                unable to make health care decisions.
                    (C) Electronic management of funds.--The 
                Secretary shall establish procedures for--
                            (i) crediting an account 
                        established on behalf of a beneficiary 
                        with the beneficiary's cash daily 
                        benefit;
                            (ii) allowing the beneficiary to 
                        access such account through debit 
                        cards; and
                            (iii) accounting for withdrawals by 
                        the beneficiary from such account.
                    (D) Primary payor rules for beneficiaries 
                who are enrolled in medicaid.--In the case of 
                an eligible beneficiary who is enrolled in 
                Medicaid, the following payment rules shall 
                apply:
                            (i) Institutionalized 
                        beneficiary.--If the beneficiary is a 
                        patient in a hospital, nursing 
                        facility, intermediate care facility 
                        for the mentally retarded, or an 
                        institution for mental diseases, the 
                        beneficiary shall retain an amount 
                        equal to 5 percent of the beneficiary's 
                        daily or weekly cash benefit (as 
                        applicable) (which shall be in addition 
                        to the amount of the beneficiary's 
                        personal needs allowance provided under 
                        Medicaid), and the remainder of such 
                        benefit shall be applied toward the 
                        facility's cost of providing the 
                        beneficiary's care, and Medicaid shall 
                        provide secondary coverage for such 
                        care.
                            (ii) Beneficiaries receiving home 
                        and community-based services.--
                                    (I) 50 percent of benefit 
                                retained by beneficiary.--
                                Subject to subclause (II), if a 
                                beneficiary is receiving 
                                medical assistance under 
                                Medicaid for home and community 
                                based services, the beneficiary 
                                shall retain an amount equal to 
                                50 percent of the beneficiary's 
                                daily or weekly cash benefit 
                                (as applicable), and the 
                                remainder of the daily or 
                                weekly cash benefit shall be 
                                applied toward the cost to the 
                                State of providing such 
                                assistance (and shall not be 
                                used to claim Federal matching 
                                funds under Medicaid), and 
                                Medicaid shall provide 
                                secondary coverage for the 
                                remainder of any costs incurred 
                                in providing such assistance.
                                    (II) Requirement for state 
                                offset.--A State shall be paid 
                                the remainder of a 
                                beneficiary's daily or weekly 
                                cash benefit under subclause 
                                (I) only if the State home and 
                                community-based waiver under 
                                section 1115 of the Social 
                                Security Act (42 U.S.C. 1315) 
                                or subsection (c) or (d) of 
                                section 1915 of such Act (42 
                                U.S.C. 1396n), or the State 
                                plan amendment under subsection 
                                (i) of such section does not 
                                include a waiver of the 
                                requirements of section 
                                1902(a)(1) of the Social 
                                Security Act (relating to 
                                statewideness) or of section 
                                1902(a)(10)(B) of such Act 
                                (relating to comparability) and 
                                the State offers at a minimum 
                                case management services, 
                                personal care services, 
                                habilitation services, and 
                                respite care under such a 
                                waiver or State plan amendment.
                                    (III) Definition of home 
                                and community-based services.--
                                In this clause, the term ``home 
                                and community-based services'' 
                                means any services which may be 
                                offered under a home and 
                                community-based waiver 
                                authorized for a State under 
                                section 1115 of the Social 
                                Security Act (42 U.S.C. 1315) 
                                or subsection (c) or (d) of 
                                section 1915 of such Act (42 
                                U.S.C. 1396n) or under a State 
                                plan amendment under subsection 
                                (i) of such section.
                            (iii) Beneficiaries enrolled in 
                        programs of all-inclusive care for the 
                        elderly (pace).--
                                    (I) In general.--Subject to 
                                subclause (II), if a 
                                beneficiary is receiving 
                                medical assistance under 
                                Medicaid for PACE program 
                                services under section 1934 of 
                                the Social Security Act (42 
                                U.S.C. 1396u-4), the 
                                beneficiary shall retain an 
                                amount equal to 50 percent of 
                                the beneficiary's daily or 
                                weekly cash benefit (as 
                                applicable), and the remainder 
                                of the daily or weekly cash 
                                benefit shall be applied toward 
                                the cost to the State of 
                                providing such assistance (and 
                                shall not be used to claim 
                                Federal matching funds under 
                                Medicaid), and Medicaid shall 
                                provide secondary coverage for 
                                the remainder of any costs 
                                incurred in providing such 
                                assistance.
                                    (II) Institutionalized 
                                recipients of pace program 
                                services.--If a beneficiary 
                                receiving assistance under 
                                Medicaid for PACE program 
                                services is a patient in a 
                                hospital, nursing facility, 
                                intermediate care facility for 
                                the mentally retarded, or an 
                                institution for mental 
                                diseases, the beneficiary shall 
                                be treated as in 
                                institutionalized beneficiary 
                                under clause (i).
            (2) Authorized representatives.--
                    (A) In general.--The Secretary shall 
                establish procedures to allow access to a 
                beneficiary's cash benefits by an authorized 
                representative of the eligible beneficiary on 
                whose behalf such benefits are paid.
                    (B) Quality assurance and protection 
                against fraud and abuse.--The procedures 
                established under subparagraph (A) shall ensure 
                that authorized representatives of eligible 
                beneficiaries comply with standards of conduct 
                established by the Secretary, including 
                standards requiring that such representatives 
                provide quality services on behalf of such 
                beneficiaries, do not have conflicts of 
                interest, and do not misuse benefits paid on 
                behalf of such beneficiaries or otherwise 
                engage in fraud or abuse.
            (3) Commencement of benefits.--Benefits shall be 
        paid to, or on behalf of, an eligible beneficiary 
        beginning with the first month in which an application 
        for such benefits is approved.
            (4) Rollover option for lump-sum payment.--An 
        eligible beneficiary may elect to--
                    (A) defer payment of their daily or weekly 
                benefit and to rollover any such deferred 
                benefits from month-to-month, but not from 
                year-to-year; and
                    (B) receive a lump-sum payment of such 
                deferred benefits in an amount that may not 
                exceed the lesser of--
                            (i) the total amount of the accrued 
                        deferred benefits; or
                            (ii) the applicable annual benefit.
            (5) Period for determination of annual benefits.--
                    (A) In general.--The applicable period for 
                determining with respect to an eligible 
                beneficiary the applicable annual benefit and 
                the amount of any accrued deferred benefits is 
                the 12-month period that commences with the 
                first month in which the beneficiary began to 
                receive such benefits, and each 12-month period 
                thereafter.
                    (B) Inclusion of increased benefits.--The 
                Secretary shall establish procedures under 
                which cash benefits paid to an eligible 
                beneficiary that increase or decrease as a 
                result of a change in the functional status of 
                the beneficiary before the end of a 12-month 
                benefit period shall be included in the 
                determination of the applicable annual benefit 
                paid to the eligible beneficiary.
                    (C) Recoupment of unpaid, accrued 
                benefits.--
                            (i) In general.--The Secretary, in 
                        coordination with the Secretary of the 
                        Treasury, shall recoup any accrued 
                        benefits in the event of--
                                    (I) the death of a 
                                beneficiary; or
                                    (II) the failure of a 
                                beneficiary to elect under 
                                paragraph (4)(B) to receive 
                                such benefits as a lump-sum 
                                payment before the end of the 
                                12-month period in which such 
                                benefits accrued.
                            (ii) Payment into class 
                        independence fund.--Any benefits 
                        recouped in accordance with clause (i) 
                        shall be paid into the CLASS 
                        Independence Fund and used in 
                        accordance with section 3206.
            (6) Requirement to recertify eligibility for 
        receipt of benefits.--An eligible beneficiary shall 
        periodically, as determined by the Secretary--
                    (A) recertify by submission of medical 
                evidence the beneficiary's continued 
                eligibility for receipt of benefits; and
                    (B) submit records of expenditures 
                attributable to the aggregate cash benefit 
                received by the beneficiary during the 
                preceding year.
            (7) Supplement, not supplant other health care 
        benefits.--Subject to the Medicaid payment rules under 
        paragraph (1)(D), benefits received by an eligible 
        beneficiary shall supplement, but not supplant, other 
        health care benefits for which the beneficiary is 
        eligible under Medicaid or any other Federally funded 
        program that provides health care benefits or 
        assistance.
    (d) Advocacy Services.--An agreement entered into under 
subsection (a)(2)(A)(ii) shall require the Protection and 
Advocacy System for the State to--
            (1) assign, as needed, an advocacy counselor to 
        each eligible beneficiary that is covered by such 
        agreement and who shall provide an eligible beneficiary 
        with--
                    (A) information regarding how to access the 
                appeals process established for the program;
                    (B) assistance with respect to the annual 
                recertification and notification required under 
                subsection (c)(6); and
                    (C) such other assistance with obtaining 
                services as the Secretary, by regulation, shall 
                require; and
            (2) ensure that the System and such counselors 
        comply with the requirements of subsection (h).
    (e) Advice and Assistance Counseling.--An agreement entered 
into under subsection (a)(2)(A)(iii) shall require the entity 
to assign, as requested by an eligible beneficiary that is 
covered by such agreement, an advice and assistance counselor 
who shall provide an eligible beneficiary with information 
regarding--
            (1) accessing and coordinating long-term services 
        and supports in the most integrated setting;
            (2) possible eligibility for other benefits and 
        services;
            (3) development of a service and support plan;
            (4) information about programs established under 
        the Assistive Technology Act of 1998 and the services 
        offered under such programs;
            (5) available assistance with decision making 
        concerning medical care, including the right to accept 
        or refuse medical or surgical treatment and the right 
        to formulate advance directives or other written 
        instructions recognized under State law, such as a 
        living will or durable power of attorney for health 
        care, in the case that an injury or illness causes the 
        individual to be unable to make health care decisions; 
        and
            (6) such other services as the Secretary, by 
        regulation, may require.
    (f) No Effect on Eligibility for Other Benefits.--Benefits 
paid to an eligible beneficiary under the CLASS program shall 
be disregarded for purposes of determining or continuing the 
beneficiary's eligibility for receipt of benefits under any 
other Federal, State, or locally funded assistance program, 
including benefits paid under titles II, XVI, XVIII, XIX, or 
XXI of the Social Security Act (42 U.S.C. 401 et seq., 1381 et 
seq., 1395 et seq., 1396 et seq., 1397aa et seq.), under the 
laws administered by the Secretary of Veterans Affairs, under 
low-income housing assistance programs, or under the 
supplemental nutrition assistance program established under the 
Food and Nutrition Act of 2008 (7 U.S.C. 2011 et seq.).
    (g) Rule of Construction.--Nothing in this title shall be 
construed as prohibiting benefits paid under the CLASS 
Independence Benefit Plan from being used to compensate a 
family caregiver for providing community living assistance 
services and supports to an eligible beneficiary.
    (h) Protection Against Conflict of Interests.--The 
Secretary shall establish procedures to ensure that the 
Eligibility Assessment System, the Protection and Advocacy 
System for a State, advocacy counselors for eligible 
beneficiaries, and any other entities that provide services to 
active enrollees and eligible beneficiaries under the CLASS 
program comply with the following:
            (1) If the entity provides counseling or planning 
        services, such services are provided in a manner that 
        fosters the best interests of the active enrollee or 
        beneficiary.
            (2) The entity has established operating procedures 
        that are designed to avoid or minimize conflicts of 
        interest between the entity and an active enrollee or 
        beneficiary.
            (3) The entity provides information about all 
        services and options available to the active enrollee 
        or beneficiary, to the best of its knowledge, including 
        services available through other entities or providers.
            (4) The entity assists the active enrollee or 
        beneficiary to access desired services, regardless of 
        the provider.
            (5) The entity reports the number of active 
        enrollees and beneficiaries provided with assistance by 
        age, disability, and whether such enrollees and 
        beneficiaries received services from the entity or 
        another entity.
            (6) If the entity provides counseling or planning 
        services, the entity ensures that an active enrollee or 
        beneficiary is informed of any financial interest that 
        the entity has in a service provider.
            (7) The entity provides an active enrollee or 
        beneficiary with a list of available service providers 
        that can meet the needs of the active enrollee or 
        beneficiary.

SEC. 3206. [300LL-5] CLASS INDEPENDENCE FUND.

    (a) Establishment of CLASS Independence Fund.--There is 
established in the Treasury of the United States a trust fund 
to be known as the `CLASS Independence Fund'. The Secretary of 
the Treasury shall serve as Managing Trustee of such Fund. The 
Fund shall consist of all amounts derived from payments into 
the Fund under sections 3204(f) and 3205(c)(5)(C)(ii), and 
remaining after investment of such amounts under subsection 
(b), including additional amounts derived as income from such 
investments. The amounts held in the Fund are appropriated and 
shall remain available without fiscal year limitation--
            (1) to be held for investment on behalf of 
        individuals enrolled in the CLASS program;
            (2) to pay the administrative expenses related to 
        the Fund and to investment under subsection (b); and
            (3) to pay cash benefits to eligible beneficiaries 
        under the CLASS Independence Benefit Plan.
    (b) Investment of Fund Balance.--The Secretary of the 
Treasury shall invest and manage the CLASS Independence Fund in 
the same manner, and to the same extent, as the Federal 
Supplementary Medical Insurance Trust Fund may be invested and 
managed under subsections (c), (d), and (e) of section 1841(d) 
of the Social Security Act (42 U.S.C. 1395t).
    (c) Board of Trustees.--
            (1) In general.--With respect to the CLASS 
        Independence Fund, there is hereby created a body to be 
        known as the Board of Trustees of the CLASS 
        Independence Fund (hereinafter in this section referred 
        to as the ``Board of Trustees'') composed of the 
        Secretary of the Treasury, the Secretary of Labor, and 
        the Secretary of Health and Human Services, all ex 
        officio, and of two members of the public (both of whom 
        may not be from the same political party), who shall be 
        nominated by the President for a term of 4 years and 
        subject to confirmation by the Senate. A member of the 
        Board of Trustees serving as a member of the public and 
        nominated and confirmed to fill a vacancy occurring 
        during a term shall be nominated and confirmed only for 
        the remainder of such term. An individual nominated and 
        confirmed as a member of the public may serve in such 
        position after the expiration of such member's term 
        until the earlier of the time at which the member's 
        successor takes office or the time at which a report of 
        the Board is first issued under paragraph (2) after the 
        expiration of the member's term. The Secretary of the 
        Treasury shall be the Managing Trustee of the Board of 
        Trustees. The Board of Trustees shall meet not less 
        frequently than once each calendar year. A person 
        serving on the Board of Trustees shall not be 
        considered to be a fiduciary and shall not be 
        personally liable for actions taken in such capacity 
        with respect to the Trust Fund.
            (2) Duties.--
                    (A) In general.--It shall be the duty of 
                the Board of Trustees to do the following:
                            (i) Hold the CLASS Independence 
                        Fund.
                            (ii) Report to the Congress not 
                        later than the first day of April of 
                        each year on the operation and status 
                        of the CLASS Independence Fund during 
                        the preceding fiscal year and on its 
                        expected operation and status during 
                        the current fiscal year and the next 2 
                        fiscal years.
                            (iii) Report immediately to the 
                        Congress whenever the Board is of the 
                        opinion that the amount of the CLASS 
                        Independence Fund is not actuarially 
                        sound in regards to the projection 
                        under section 3203(b)(1)(B)(i).
                            (iv) Review the general policies 
                        followed in managing the CLASS 
                        Independence Fund, and recommend 
                        changes in such policies, including 
                        necessary changes in the provisions of 
                        law which govern the way in which the 
                        CLASS Independence Fund is to be 
                        managed.
                    (B) Report.--The report provided for in 
                subparagraph (A)(ii) shall--
                            (i) include--
                                    (I) a statement of the 
                                assets of, and the 
                                disbursements made from, the 
                                CLASS Independence Fund during 
                                the preceding fiscal year;
                                    (II) an estimate of the 
                                expected income to, and 
                                disbursements to be made from, 
                                the CLASS Independence Fund 
                                during the current fiscal year 
                                and each of the next 2 fiscal 
                                years;
                                    (III) a statement of the 
                                actuarial status of the CLASS 
                                Independence Fund for the 
                                current fiscal year, each of 
                                the next 2 fiscal years, and as 
                                projected over the 75-year 
                                period beginning with the 
                                current fiscal year; and
                                    (IV) an actuarial opinion 
                                by the Chief Actuary of the 
                                Centers for Medicare & Medicaid 
                                Services certifying that the 
                                techniques and methodologies 
                                used are generally accepted 
                                within the actuarial profession 
                                and that the assumptions and 
                                cost estimates used are 
                                reasonable; and
                            (ii) be printed as a House document 
                        of the session of the Congress to which 
                        the report is made.
                    (C) Recommendations.--If the Board of 
                Trustees determines that enrollment trends and 
                expected future benefit claims on the CLASS 
                Independence Fund are not actuarially sound in 
                regards to the projection under section 
                3203(b)(1)(B)(i) and are unlikely to be 
                resolved with reasonable premium increases or 
                through other means, the Board of Trustees 
                shall include in the report provided for in 
                subparagraph (A)(ii) recommendations for such 
                legislative action as the Board of Trustees 
                determine to be appropriate, including whether 
                to adjust monthly premiums or impose a 
                temporary moratorium on new enrollments.

SEC. 3207. [300LL-6] CLASS INDEPENDENCE ADVISORY COUNCIL.

    (a) Establishment.--There is hereby created an Advisory 
Committee to be known as the ``CLASS Independence Advisory 
Council''.
    (b) Membership.--
            (1) In general.--The CLASS Independence Advisory 
        Council shall be composed of not more than 15 
        individuals, not otherwise in the employ of the United 
        States--
                    (A) who shall be appointed by the President 
                without regard to the civil service laws and 
                regulations; and
                    (B) a majority of whom shall be 
                representatives of individuals who participate 
                or are likely to participate in the CLASS 
                program, and shall include representatives of 
                older and younger workers, individuals with 
                disabilities, family caregivers of individuals 
                who require services and supports to maintain 
                their independence at home or in another 
                residential setting of their choice in the 
                community, individuals with expertise in long-
                term care or disability insurance, actuarial 
                science, economics, and other relevant 
                disciplines, as determined by the Secretary.
            (2) Terms.--
                    (A) In general.--The members of the CLASS 
                Independence Advisory Council shall serve 
                overlapping terms of 3 years (unless appointed 
                to fill a vacancy occurring prior to the 
                expiration of a term, in which case the 
                individual shall serve for the remainder of the 
                term).
                    (B) Limitation.--A member shall not be 
                eligible to serve for more than 2 consecutive 
                terms.
            (3) Chair.--The President shall, from time to time, 
        appoint one of the members of the CLASS Independence 
        Advisory Council to serve as the Chair.
    (c) Duties.--The CLASS Independence Advisory Council shall 
advise the Secretary on matters of general policy in the 
administration of the CLASS program established under this 
title and in the formulation of regulations under this title 
including with respect to--
            (1) the development of the CLASS Independence 
        Benefit Plan under section 3203;
            (2) the determination of monthly premiums under 
        such plan; and
            (3) the financial solvency of the program.
    (d) Application of FACA.--The Federal Advisory Committee 
Act (5 U.S.C. App.), other than section 14 of that Act, shall 
apply to the CLASS Independence Advisory Council.
    (e) Authorization of Appropriations.--
            (1) In general.--There are authorized to be 
        appropriated to the CLASS Independence Advisory Council 
        to carry out its duties under this section, such sums 
        as may be necessary for fiscal year 2011 and for each 
        fiscal year thereafter.
            (2) Availability.--Any sums appropriated under the 
        authorization contained in this section shall remain 
        available, without fiscal year limitation, until 
        expended.

SEC. 3208. [300LL-7] SOLVENCY AND FISCAL INDEPENDENCE; REGULATIONS; 
                    ANNUAL REPORT.

    (a) Solvency.--The Secretary shall regularly consult with 
the Board of Trustees of the CLASS Independence Fund and the 
CLASS Independence Advisory Council, for purposes of ensuring 
that enrollees premiums are adequate to ensure the financial 
solvency of the CLASS program, both with respect to fiscal 
years occurring in the near-term and fiscal years occurring 
over 20- and 75-year periods, taking into account the 
projections required for such periods under subsections 
(a)(1)(A)(i) and (b)(1)(B)(i) of section 3202.
    (b) No Taxpayer Funds Used To Pay Benefits.--No taxpayer 
funds shall be used for payment of benefits under a CLASS 
Independent Benefit Plan. For purposes of this subsection, the 
term ``taxpayer funds'' means any Federal funds from a source 
other than premiums deposited by CLASS program participants in 
the CLASS Independence Fund and any associated interest 
earnings.
    (c) Regulations.--The Secretary shall promulgate such 
regulations as are necessary to carry out the CLASS program in 
accordance with this title. Such regulations shall include 
provisions to prevent fraud and abuse under the program.
    (d) Annual Report.--Beginning January 1, 2014, the 
Secretary shall submit an annual report to Congress on the 
CLASS program. Each report shall include the following:
            (1) The total number of enrollees in the program.
            (2) The total number of eligible beneficiaries 
        during the fiscal year.
            (3) The total amount of cash benefits provided 
        during the fiscal year.
            (4) A description of instances of fraud or abuse 
        identified during the fiscal year.
            (5) Recommendations for such administrative or 
        legislative action as the Secretary determines is 
        necessary to improve the program, ensure the solvency 
        of the program, or to prevent the occurrence of fraud 
        or abuse.

SEC. 3209. [300LL-8] INSPECTOR GENERAL'S REPORT.

    The Inspector General of the Department of Health and Human 
Services shall submit an annual report to the Secretary and 
Congress relating to the overall progress of the CLASS program 
and of the existence of waste, fraud, and abuse in the CLASS 
program. Each such report shall include findings in the 
following areas:
            (1) The eligibility determination process.
            (2) The provision of cash benefits.
            (3) Quality assurance and protection against waste, 
        fraud, and abuse.
            (4) Recouping of unpaid and accrued benefits.

SEC. 3210. [300LL-9] TAX TREATMENT OF PROGRAM.

    The CLASS program shall be treated for purposes of the 
Internal Revenue Code of 1986 in the same manner as a qualified 
long-term care insurance contract for qualified long-term care 
services.
            TITLE XXXIII--WORLD TRADE CENTER HEALTH PROGRAM

        Subtitle A--Establishment of Program; Advisory Committee

SEC. 3301. ESTABLISHMENT OF WORLD TRADE CENTER HEALTH PROGRAM.

    (a) In General.--There is hereby established within the 
Department of Health and Human Services a program to be known 
as the World Trade Center Health Program, which shall be 
administered by the WTC Program Administrator, to provide 
beginning on July 1, 2011--
            (1) medical monitoring and treatment benefits to 
        eligible emergency responders and recovery and cleanup 
        workers (including those who are Federal employees) who 
        responded to the September 11, 2001, terrorist attacks; 
        and
            (2) initial health evaluation, monitoring, and 
        treatment benefits to residents and other building 
        occupants and area workers in New York City who were 
        directly impacted and adversely affected by such 
        attacks.
    (b) Components of Program.--The WTC Program includes the 
following components:
            (1) Medical monitoring for responders.--Medical 
        monitoring under section 3311, including clinical 
        examinations and long-term health monitoring and 
        analysis for enrolled WTC responders who were likely to 
        have been exposed to airborne toxins that were 
        released, or to other hazards, as a result of the 
        September 11, 2001, terrorist attacks.
            (2) Initial health evaluation for survivors.--An 
        initial health evaluation under section 3321, including 
        an evaluation to determine eligibility for followup 
        monitoring and treatment.
            (3) Followup monitoring and treatment for wtc-
        related health conditions for responders and 
        survivors.--Provision under sections 3312, 3322, and 
        3323 of followup monitoring and treatment and payment, 
        subject to the provisions of subsection (d), for all 
        medically necessary health and mental health care 
        expenses of an individual with respect to a WTC-related 
        health condition (including necessary prescription 
        drugs).
            (4) Outreach.--Establishment under section 3303 of 
        an education and outreach program to potentially 
        eligible individuals concerning the benefits under this 
        title.
            (5) Clinical data collection and analysis.--
        Collection and analysis under section 3304 of health 
        and mental health data relating to individuals 
        receiving monitoring or treatment benefits in a uniform 
        manner in collaboration with the collection of 
        epidemiological data under section 3342.
            (6) Research on health conditions.--Establishment 
        under subtitle C of a research program on health 
        conditions resulting from the September 11, 2001, 
        terrorist attacks.
    (c) No Cost Sharing.--Monitoring and treatment benefits and 
initial health evaluation benefits are provided under subtitle 
B without any deductibles, copayments, or other cost sharing to 
an enrolled WTC responder or certified-eligible WTC survivor. 
Initial health evaluation benefits are provided under subtitle 
B without any deductibles, copayments, or other cost sharing to 
a screening-eligible WTC survivor.
    (d) Preventing Fraud and Unreasonable Administrative 
Costs.--
            (1) Fraud.--The Inspector General of the Department 
        of Health and Human Services shall develop and 
        implement a program to review the WTC Program's health 
        care expenditures to detect fraudulent or duplicate 
        billing and payment for inappropriate services. This 
        title is a Federal health care program (as defined in 
        section 1128B(f) of the Social Security Act) and is a 
        health plan (as defined in section 1128C(c) of such 
        Act) for purposes of applying sections 1128 through 
        1128E of such Act.
            (2) Unreasonable administrative costs.--The 
        Inspector General of the Department of Health and Human 
        Services shall develop and implement a program to 
        review the WTC Program for unreasonable administrative 
        costs, including with respect to infrastructure, 
        administration, and claims processing.
    (e) Quality Assurance.--The WTC Program Administrator 
working with the Clinical Centers of Excellence shall develop 
and implement a quality assurance program for the monitoring 
and treatment delivered by such Centers of Excellence and any 
other participating health care providers. Such program shall 
include--
            (1) adherence to monitoring and treatment 
        protocols;
            (2) appropriate diagnostic and treatment referrals 
        for participants;
            (3) prompt communication of test results to 
        participants; and
            (4) such other elements as the Administrator 
        specifies in consultation with the Clinical Centers of 
        Excellence.
    (f) Annual Program Report.--
            (1) In general.--Not later than 6 months after the 
        end of each fiscal year in which the WTC Program is in 
        operation, the WTC Program Administrator shall submit 
        an annual report to the Congress on the operations of 
        this title for such fiscal year and for the entire 
        period of operation of the program.
            (2) Contents included in report.--Each annual 
        report under paragraph (1) shall include at least the 
        following:
                    (A) Eligible individuals.--Information for 
                each clinical program described in paragraph 
                (3)--
                            (i) on the number of individuals 
                        who applied for certification under 
                        subtitle B and the number of such 
                        individuals who were so certified;
                            (ii) of the individuals who were 
                        certified, on the number who received 
                        monitoring under the program and the 
                        number of such individuals who received 
                        medical treatment under the program;
                            (iii) with respect to individuals 
                        so certified who received such 
                        treatment, on the WTC-related health 
                        conditions for which they were treated; 
                        and
                            (iv) on the projected number of 
                        individuals who will be certified under 
                        subtitle B in the succeeding fiscal 
                        year and the succeeding 10-year period.
                    (B) Monitoring, initial health evaluation, 
                and treatment costs.--For each clinical program 
                so described--
                            (i) information on the costs of 
                        monitoring and initial health 
                        evaluation and the costs of treatment 
                        and on the estimated costs of such 
                        monitoring, evaluation, and treatment 
                        in the succeeding fiscal year; and
                            (ii) an estimate of the cost of 
                        medical treatment for WTC-related 
                        health conditions that have been paid 
                        for or reimbursed by workers' 
                        compensation, by public or private 
                        health plans, or by New York City under 
                        section 3331.
                    (C) Administrative costs.--Information on 
                the cost of administering the program, 
                including costs of program support, data 
                collection and analysis, and research conducted 
                under the program.
                    (D) Administrative experience.--Information 
                on the administrative performance of the 
                program, including--
                            (i) the performance of the program 
                        in providing timely evaluation of and 
                        treatment to eligible individuals; and
                            (ii) a list of the Clinical Centers 
                        of Excellence and other providers that 
                        are participating in the program.
                    (E) Scientific reports.--A summary of the 
                findings of any new scientific reports or 
                studies on the health effects associated with 
                exposure described in section 3306(1), 
                including the findings of research conducted 
                under section 3341(a).
                    (F) Advisory committee recommendations.--A 
                list of recommendations by the WTC Scientific/
                Technical Advisory Committee on additional WTC 
                Program eligibility criteria and on additional 
                WTC-related health conditions and the action of 
                the WTC Program Administrator concerning each 
                such recommendation.
            (3) Separate clinical programs described.--In 
        paragraph (2), each of the following shall be treated 
        as a separate clinical program of the WTC Program:
                    (A) Firefighters and related personnel.--
                The benefits provided for enrolled WTC 
                responders described in section 3311(a)(2)(A).
                    (B) Other wtc responders.--The benefits 
                provided for enrolled WTC responders not 
                described in subparagraph (A).
                    (C) WTC survivors.--The benefits provided 
                for screening-eligible WTC survivors and 
                certified-eligible WTC survivors in section 
                3321(a).
    (g) Notification to Congress Upon Reaching 80 Percent of 
Eligibility Numerical Limits.--The Secretary shall promptly 
notify the Congress of each of the following:
            (1) When the number of enrollments of WTC 
        responders subject to the limit established under 
        section 3311(a)(4) has reached 80 percent of such 
        limit.
            (2) When the number of certifications for 
        certified-eligible WTC survivors subject to the limit 
        established under section 3321(a)(3) has reached 80 
        percent of such limit.
    (h) Consultation.--The WTC Program Administrator shall 
engage in ongoing outreach and consultation with relevant 
stakeholders, including the WTC Health Program Steering 
Committees and the Advisory Committee under section 3302, 
regarding the implementation and improvement of programs under 
this title.

SEC. 3302. WTC HEALTH PROGRAM SCIENTIFIC/TECHNICAL ADVISORY COMMITTEE; 
                    WTC HEALTH PROGRAM STEERING COMMITTEES.

    (a) Advisory Committee.--
            (1) Establishment.--The WTC Program Administrator 
        shall establish an advisory committee to be known as 
        the WTC Health Program Scientific/Technical Advisory 
        Committee (in this subsection referred to as the 
        ``Advisory Committee'') to review scientific and 
        medical evidence and to make recommendations to the 
        Administrator on additional WTC Program eligibility 
        criteria and on additional WTC-related health 
        conditions.
            (2) Composition.--The WTC Program Administrator 
        shall appoint the members of the Advisory Committee and 
        shall include at least--
                    (A) 4 occupational physicians, at least 2 
                of whom have experience treating WTC rescue and 
                recovery workers;
                    (B) 1 physician with expertise in pulmonary 
                medicine;
                    (C) 2 environmental medicine or 
                environmental health specialists;
                    (D) 2 representatives of WTC responders;
                    (E) 2 representatives of certified-eligible 
                WTC survivors;
                    (F) an industrial hygienist;
                    (G) a toxicologist;
                    (H) an epidemiologist; and
                    (I) a mental health professional.
            (3) Meetings.--The Advisory Committee shall meet at 
        such frequency as may be required to carry out its 
        duties.
            (4) Reports.--The WTC Program Administrator shall 
        provide for publication of recommendations of the 
        Advisory Committee on the public Web site established 
        for the WTC Program.
            (5) Duration.--Notwithstanding any other provision 
        of law, the Advisory Committee shall continue in 
        operation during the period in which the WTC Program is 
        in operation.
            (6) Application of faca.--Except as otherwise 
        specifically provided, the Advisory Committee shall be 
        subject to the Federal Advisory Committee Act.
    (b) WTC Health Program Steering Committees.--
            (1) Consultation.--The WTC Program Administrator 
        shall consult with 2 steering committees (each in this 
        section referred to as a ``Steering Committee'') that 
        are established as follows:
                    (A) WTC responders steering committee.--One 
                Steering Committee, to be known as the WTC 
                Responders Steering Committee, for the purpose 
                of receiving input from affected stakeholders 
                and facilitating the coordination of monitoring 
                and treatment programs for the enrolled WTC 
                responders under part 1 of subtitle B.
                    (B) WTC survivors steering committee.--One 
                Steering Committee, to be known as the WTC 
                Survivors Steering Committee, for the purpose 
                of receiving input from affected stakeholders 
                and facilitating the coordination of initial 
                health evaluations, monitoring, and treatment 
                programs for screening-eligible and certified-
                eligible WTC survivors under part 2 of subtitle 
                B.
            (2) Membership.--
                    (A) WTC responders steering committee.--
                            (i) Representation.--The WTC 
                        Responders Steering Committee shall 
                        include--
                                    (I) representatives of the 
                                Centers of Excellence providing 
                                services to WTC responders;
                                    (II) representatives of 
                                labor organizations 
                                representing firefighters, 
                                police, other New York City 
                                employees, and recovery and 
                                cleanup workers who responded 
                                to the September 11, 2001, 
                                terrorist attacks; and
                                    (III) 3 representatives of 
                                New York City, 1 of whom will 
                                be selected by the police 
                                commissioner of New York City, 
                                1 by the health commissioner of 
                                New York City, and 1 by the 
                                mayor of New York City.
                            (ii) Initial membership.--The WTC 
                        Responders Steering Committee shall 
                        initially be composed of members of the 
                        WTC Monitoring and Treatment Program 
                        Steering Committee (as in existence on 
                        the day before the date of the 
                        enactment of this title).
                    (B) WTC survivors steering committee.--
                            (i) Representation.--The WTC 
                        Survivors Steering Committee shall 
                        include representatives of--
                                    (I) the Centers of 
                                Excellence providing services 
                                to screening-eligible and 
                                certified-eligible WTC 
                                survivors;
                                    (II) the population of 
                                residents, students, and area 
                                and other workers affected by 
                                the September 11, 2001, 
                                terrorist attacks;
                                    (III) screening-eligible 
                                and certified-eligible 
                                survivors receiving initial 
                                health evaluations, monitoring, 
                                or treatment under part 2 of 
                                subtitle B and organizations 
                                advocating on their behalf; and
                                    (IV) New York City.
                            (ii) Initial membership.--The WTC 
                        Survivors Steering Committee shall 
                        initially be composed of members of the 
                        WTC Environmental Health Center 
                        Survivor Advisory Committee (as in 
                        existence on the day before the date of 
                        the enactment of this title).
                    (C) Additional appointments.--Each Steering 
                Committee may recommend, if approved by a 
                majority of voting members of the Committee, 
                additional members to the Committee.
                    (D) Vacancies.--A vacancy in a Steering 
                Committee shall be filled by an individual 
                recommended by the Steering Committee.

SEC. 3303. EDUCATION AND OUTREACH.

    The WTC Program Administrator shall institute a program 
that provides education and outreach on the existence and 
availability of services under the WTC Program. The outreach 
and education program--
            (1) shall include--
                    (A) the establishment of a public Web site 
                with information about the WTC Program;
                    (B) meetings with potentially eligible 
                populations;
                    (C) development and dissemination of 
                outreach materials informing people about the 
                program; and
                    (D) the establishment of phone information 
                services; and
            (2) shall be conducted in a manner intended--
                    (A) to reach all affected populations; and
                    (B) to include materials for culturally and 
                linguistically diverse populations.

SEC. 3304. UNIFORM DATA COLLECTION AND ANALYSIS.

    (a) In General.--The WTC Program Administrator shall 
provide for the uniform collection of data, including claims 
data (and analysis of data and regular reports to the 
Administrator) on the prevalence of WTC-related health 
conditions and the identification of new WTC-related health 
conditions. Such data shall be collected for all individuals 
provided monitoring or treatment benefits under subtitle B and 
regardless of their place of residence or Clinical Center of 
Excellence through which the benefits are provided. The WTC 
Program Administrator shall provide, through the Data Centers 
or otherwise, for the integration of such data into the 
monitoring and treatment program activities under this title.
    (b) Coordinating Through Centers of Excellence.--Each 
Clinical Center of Excellence shall collect data described in 
subsection (a) and report such data to the corresponding Data 
Center for analysis by such Data Center.
    (c) Collaboration With WTC Health Registry.--The WTC 
Program Administrator shall provide for collaboration between 
the Data Centers and the World Trade Center Health Registry 
described in section 3342.
    (d) Privacy.--The data collection and analysis under this 
section shall be conducted and maintained in a manner that 
protects the confidentiality of individually identifiable 
health information consistent with applicable statutes and 
regulations, including, as applicable, HIPAA privacy and 
security law (as defined in section 3009(a)(2)) and section 
552a of title 5, United States Code.

SEC. 3305. CLINICAL CENTERS OF EXCELLENCE AND DATA CENTERS.

    (a) In General.--
            (1) Contracts with clinical centers of 
        excellence.--The WTC Program Administrator shall, 
        subject to subsection (b)(1)(B), enter into contracts 
        with Clinical Centers of Excellence (as defined in 
        subsection (b)(1)(A))--
                    (A) for the provision of monitoring and 
                treatment benefits and initial health 
                evaluation benefits under subtitle B;
                    (B) for the provision of outreach 
                activities to individuals eligible for such 
                monitoring and treatment benefits, for initial 
                health evaluation benefits, and for followup to 
                individuals who are enrolled in the monitoring 
                program;
                    (C) for the provision of counseling for 
                benefits under subtitle B, with respect to WTC-
                related health conditions, for individuals 
                eligible for such benefits;
                    (D) for the provision of counseling for 
                benefits for WTC-related health conditions that 
                may be available under workers' compensation or 
                other benefit programs for work-related 
                injuries or illnesses, health insurance, 
                disability insurance, or other insurance plans 
                or through public or private social service 
                agencies and assisting eligible individuals in 
                applying for such benefits;
                    (E) for the provision of translational and 
                interpretive services for program participants 
                who are not English language proficient; and
                    (F) for the collection and reporting of 
                data, including claims data, in accordance with 
                section 3304.
            (2) Contracts with data centers.--
                    (A) In general.--The WTC Program 
                Administrator shall enter into contracts with 
                one or more Data Centers (as defined in 
                subsection (b)(2))--
                            (i) for receiving, analyzing, and 
                        reporting to the WTC Program 
                        Administrator on data, in accordance 
                        with section 3304, that have been 
                        collected and reported to such Data 
                        Centers by the corresponding Clinical 
                        Centers of Excellence under subsection 
                        (b)(1)(B)(iii);
                            (ii) for the development of 
                        monitoring, initial health evaluation, 
                        and treatment protocols, with respect 
                        to WTC-related health conditions;
                            (iii) for coordinating the outreach 
                        activities conducted under paragraph 
                        (1)(B) by each corresponding Clinical 
                        Center of Excellence;
                            (iv) for establishing criteria for 
                        the credentialing of medical providers 
                        participating in the nationwide network 
                        under section 3313;
                            (v) for coordinating and 
                        administering the activities of the WTC 
                        Health Program Steering Committees 
                        established under section 3002(b); and
                            (vi) for meeting periodically with 
                        the corresponding Clinical Centers of 
                        Excellence to obtain input on the 
                        analysis and reporting of data 
                        collected under clause (i) and on the 
                        development of monitoring, initial 
                        health evaluation, and treatment 
                        protocols under clause (ii).
                    (B) Medical provider selection.--The 
                medical providers under subparagraph (A)(iv) 
                shall be selected by the WTC Program 
                Administrator on the basis of their experience 
                treating or diagnosing the health conditions 
                included in the list of WTC-related health 
                conditions.
                    (C) Clinical discussions.--In carrying out 
                subparagraph (A)(ii), a Data Center shall 
                engage in clinical discussions across the WTC 
                Program to guide treatment approaches for 
                individuals with a WTC-related health 
                condition.
                    (D) Transparency of data.--A contract 
                entered into under this subsection with a Data 
                Center shall require the Data Center to make 
                any data collected and reported to such Center 
                under subsection (b)(1)(B)(iii) available to 
                health researchers and others as provided in 
                the CDC/ATSDR Policy on Releasing and Sharing 
                Data.
            (3) Authority for contracts to be class specific.--
        A contract entered into under this subsection with a 
        Clinical Center of Excellence or a Data Center may be 
        with respect to one or more class of enrolled WTC 
        responders, screening-eligible WTC survivors, or 
        certified-eligible WTC survivors.
            (4) Use of cooperative agreements.--Any contract 
        under this title between the WTC Program Administrator 
        and a Data Center or a Clinical Center of Excellence 
        may be in the form of a cooperative agreement.
            (5) Review on feasibility of consolidating data 
        centers.--Not later than July 1, 2011, the Comptroller 
        General of the United States shall submit to the 
        Committee on Energy and Commerce of the House of 
        Representatives and the Committee on Health, Education, 
        Labor, and Pensions of the Senate a report on the 
        feasibility of consolidating Data Centers into a single 
        Data Center.
    (b) Centers of Excellence.--
            (1) Clinical centers of excellence.--
                    (A) Definition.--For purposes of this 
                title, the term ``Clinical Center of 
                Excellence'' means a Center that demonstrates 
                to the satisfaction of the Administrator that 
                the Center--
                            (i) uses an integrated, centralized 
                        health care provider approach to create 
                        a comprehensive suite of health 
                        services under this title that are 
                        accessible to enrolled WTC responders, 
                        screening-eligible WTC survivors, or 
                        certified-eligible WTC survivors;
                            (ii) has experience in caring for 
                        WTC responders and screening-eligible 
                        WTC survivors or includes health care 
                        providers who have been trained 
                        pursuant to section 3313(c);
                            (iii) employs health care provider 
                        staff with expertise that includes, at 
                        a minimum, occupational medicine, 
                        environmental medicine, trauma-related 
                        psychiatry and psychology, and social 
                        services counseling; and
                            (iv) meets such other requirements 
                        as specified by the Administrator.
                    (B) Contract requirements.--The WTC Program 
                Administrator shall not enter into a contract 
                with a Clinical Center of Excellence under 
                subsection (a)(1) unless the Center agrees to 
                do each of the following:
                            (i) Establish a formal mechanism 
                        for consulting with and receiving input 
                        from representatives of eligible 
                        populations receiving monitoring and 
                        treatment benefits under subtitle B 
                        from such Center.
                            (ii) Coordinate monitoring and 
                        treatment benefits under subtitle B 
                        with routine medical care provided for 
                        the treatment of conditions other than 
                        WTC-related health conditions.
                            (iii) Collect and report to the 
                        corresponding Data Center data, 
                        including claims data, in accordance 
                        with section 3304(b).
                            (iv) Have in place safeguards 
                        against fraud that are satisfactory to 
                        the Administrator, in consultation with 
                        the Inspector General of the Department 
                        of Health and Human Services.
                            (v) Treat or refer for treatment 
                        all individuals who are enrolled WTC 
                        responders or certified-eligible WTC 
                        survivors with respect to such Center 
                        who present themselves for treatment of 
                        a WTC-related health condition.
                            (vi) Have in place safeguards, 
                        consistent with section 3304(c), to 
                        ensure the confidentiality of an 
                        individual's individually identifiable 
                        health information, including requiring 
                        that such information not be disclosed 
                        to the individual's employer without 
                        the authorization of the individual.
                            (vii) Use amounts paid under 
                        subsection (c)(1) only for costs 
                        incurred in carrying out the activities 
                        described in subsection (a), other than 
                        those described in subsection 
                        (a)(1)(A).
                            (viii) Utilize health care 
                        providers with occupational and 
                        environmental medicine expertise to 
                        conduct physical and mental health 
                        assessments, in accordance with 
                        protocols developed under subsection 
                        (a)(2)(A)(ii).
                            (ix) Communicate with WTC 
                        responders and screening-eligible and 
                        certified-eligible WTC survivors in 
                        appropriate languages and conduct 
                        outreach activities with relevant 
                        stakeholder worker or community 
                        associations.
                            (x) Meet all the other applicable 
                        requirements of this title, including 
                        regulations implementing such 
                        requirements.
                    (C) Transition rule to ensure continuity of 
                care.--The WTC Program Administrator shall to 
                the maximum extent feasible ensure continuity 
                of care in any period of transition from 
                monitoring and treatment of an enrolled WTC 
                responder or certified-eligible WTC survivor by 
                a provider to a Clinical Center of Excellence 
                or a health care provider participating in the 
                nationwide network under section 3313.
            (2) Data centers.--For purposes of this title, the 
        term ``Data Center'' means a Center that the WTC 
        Program Administrator determines has the capacity to 
        carry out the responsibilities for a Data Center under 
        subsection (a)(2).
            (3) Corresponding centers.--For purposes of this 
        title, a Clinical Center of Excellence and a Data 
        Center shall be treated as ``corresponding'' to the 
        extent that such Clinical Center and Data Center serve 
        the same population group.
    (c) Payment for Infrastructure Costs.--
            (1) In general.--The WTC Program Administrator 
        shall reimburse a Clinical Center of Excellence for the 
        fixed infrastructure costs of such Center in carrying 
        out the activities described in subtitle B at a rate 
        negotiated by the Administrator and such Centers. Such 
        negotiated rate shall be fair and appropriate and take 
        into account the number of enrolled WTC responders 
        receiving services from such Center under this title.
            (2) Fixed infrastructure costs.--For purposes of 
        paragraph (1), the term ``fixed infrastructure costs'' 
        means, with respect to a Clinical Center of Excellence, 
        the costs incurred by such Center that are not 
        otherwise reimbursable by the WTC Program Administrator 
        under section 3312(c) for patient evaluation, 
        monitoring, or treatment but which are needed to 
        operate the WTC program such as the costs involved in 
        outreach to participants or recruiting participants, 
        data collection and analysis, social services for 
        counseling patients on other available assistance 
        outside the WTC program, and the development of 
        treatment protocols. Such term does not include costs 
        for new construction or other capital costs.
    (d) GAO Analysis.--Not later than July 1, 2011, the 
Comptroller General shall submit to the Committee on Energy and 
Commerce of the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Senate an 
analysis on whether Clinical Centers of Excellence with which 
the WTC Program Administrator enters into a contract under this 
section have financial systems that will allow for the timely 
submission of claims data for purposes of section 3304 and 
subsections (a)(1)(F) and (b)(1)(B)(iii).

SEC. 3306. DEFINITIONS.

    In this title:
            (1) The term ``aggravating'' means, with respect to 
        a health condition, a health condition that existed on 
        September 11, 2001, and that, as a result of exposure 
        to airborne toxins, any other hazard, or any other 
        adverse condition resulting from the September 11, 
        2001, terrorist attacks, requires medical treatment 
        that is (or will be) in addition to, more frequent 
        than, or of longer duration than the medical treatment 
        that would have been required for such condition in the 
        absence of such exposure.
            (2) The term ``certified-eligible WTC survivor'' 
        has the meaning given such term in section 3321(a)(2).
            (3) The terms ``Clinical Center of Excellence'' and 
        ``Data Center'' have the meanings given such terms in 
        section 3305.
            (4) The term ``enrolled WTC responder'' means a WTC 
        responder enrolled under section 3311(a)(3).
            (5) The term ``initial health evaluation'' 
        includes, with respect to an individual, a medical and 
        exposure history, a physical examination, and 
        additional medical testing as needed to evaluate 
        whether the individual has a WTC-related health 
        condition and is eligible for treatment under the WTC 
        Program.
            (6) The term ``list of WTC-related health 
        conditions'' means--
                    (A) for WTC responders, the health 
                conditions listed in section 3312(a)(3); and
                    (B) for screening-eligible and certified-
                eligible WTC survivors, the health conditions 
                listed in section 3322(b).
            (7) The term ``New York City disaster area'' means 
        the area within New York City that is--
                    (A) the area of Manhattan that is south of 
                Houston Street; and
                    (B) any block in Brooklyn that is wholly or 
                partially contained within a 1.5-mile radius of 
                the former World Trade Center site.
            (8) The term ``New York metropolitan area'' means 
        an area, specified by the WTC Program Administrator, 
        within which WTC responders and eligible WTC screening-
        eligible survivors who reside in such area are 
        reasonably able to access monitoring and treatment 
        benefits and initial health evaluation benefits under 
        this title through a Clinical Center of Excellence 
        described in subparagraphs (A), (B), or (C) of section 
        3305(b)(1).
            (9) The term ``screening-eligible WTC survivor'' 
        has the meaning given such term in section 3321(a)(1).
            (10) Any reference to ``September 11, 2001'' shall 
        be deemed a reference to the period on such date 
        subsequent to the terrorist attacks at the World Trade 
        Center, Shanksville, Pennsylvania, or the Pentagon, as 
        applicable, on such date.
            (11) The term ``September 11, 2001, terrorist 
        attacks'' means the terrorist attacks that occurred on 
        September 11, 2001, in New York City, in Shanksville, 
        Pennsylvania, and at the Pentagon, and includes the 
        aftermath of such attacks.
            (12) The term ``WTC Health Program Steering 
        Committee'' means such a Steering Committee established 
        under section 3302(b).
            (13) The term ``WTC Program'' means the Word Trade 
        Center Health Program established under section 
        3301(a).
            (14)(A) The term ``WTC Program Administrator'' 
        means--
                    (i) subject to subparagraph (B), with 
                respect to paragraphs (3) and (4) of section 
                3311(a) (relating to enrollment of WTC 
                responders), section 3312(c) and the 
                corresponding provisions of section 3322 
                (relating to payment for initial health 
                evaluation, monitoring, and treatment, 
                paragraphs (1)(C), (2)(B), and (3) of section 
                3321(a) (relating to determination or 
                certification of screening-eligible or 
                certified-eligible WTC responders), and part 3 
                of subtitle B (relating to payor provisions), 
                an official in the Department of Health and 
                Human Services, to be designated by the 
                Secretary; and
                    (ii) with respect to any other provision of 
                this title, the Director of the National 
                Institute for Occupational Safety and Health, 
                or a designee of such Director.
            (B) In no case may the Secretary designate under 
        subparagraph (A)(i) the Director of the National 
        Institute for Occupational Safety and Health or a 
        designee of such Director with respect to section 3322 
        (relating to payment for initial health evaluation, 
        monitoring, and treatment).
            (15) The term ``WTC-related health condition'' is 
        defined in section 3312(a).
            (16) The term ``WTC responder'' is defined in 
        section 3311(a).
            (17) The term ``WTC Scientific/Technical Advisory 
        Committee'' means such Committee established under 
        section 3302(a).

  Subtitle B--Program of Monitoring, Initial Health Evaluations, and 
                               Treatment

                         PART 1--WTC RESPONDERS

SEC. 3311. IDENTIFICATION OF WTC RESPONDERS AND PROVISION OF WTC-
                    RELATED MONITORING SERVICES.

    (a) WTC Responder Defined.--
            (1) In general.--For purposes of this title, the 
        term ``WTC responder'' means any of the following 
        individuals, subject to paragraph (4):
                    (A) Currently identified responder.--An 
                individual who has been identified as eligible 
                for monitoring under the arrangements as in 
                effect on the date of the enactment of this 
                title between the National Institute for 
                Occupational Safety and Health and--
                            (i) the consortium coordinated by 
                        Mt. Sinai Hospital in New York City 
                        that coordinates the monitoring and 
                        treatment for enrolled WTC responders 
                        other than with respect to those 
                        covered under the arrangement with the 
                        Fire Department of New York City; or
                            (ii) the Fire Department of New 
                        York City.
                    (B) Responder who meets current eligibility 
                criteria.--An individual who meets the current 
                eligibility criteria described in paragraph 
                (2).
                    (C) Responder who meets modified 
                eligibility criteria.--An individual who--
                            (i) performed rescue, recovery, 
                        demolition, debris cleanup, or other 
                        related services in the New York City 
                        disaster area in response to the 
                        September 11, 2001, terrorist attacks, 
                        regardless of whether such services 
                        were performed by a State or Federal 
                        employee or member of the National 
                        Guard or otherwise; and
                            (ii) meets such eligibility 
                        criteria relating to exposure to 
                        airborne toxins, other hazards, or 
                        adverse conditions resulting from the 
                        September 11, 2001, terrorist attacks 
                        as the WTC Program Administrator, after 
                        consultation with the WTC Scientific/
                        Technical Advisory Committee, 
                        determines appropriate.
                The WTC Program Administrator shall not modify 
                such eligibility criteria on or after the date 
                that the number of enrollments of WTC 
                responders has reached 80 percent of the limit 
                described in paragraph (4) or on or after the 
                date that the number of certifications for 
                certified-eligible WTC survivors under section 
                3321(a)(2)(B) has reached 80 percent of the 
                limit described in section 3321(a)(3).
            (2) Current eligibility criteria.--The eligibility 
        criteria described in this paragraph for an individual 
        is that the individual is described in any of the 
        following categories:
                    (A) Firefighters and related personnel.--
                The individual--
                            (i) was a member of the Fire 
                        Department of New York City (whether 
                        fire or emergency personnel, active or 
                        retired) who participated at least one 
                        day in the rescue and recovery effort 
                        at any of the former World Trade Center 
                        sites (including Ground Zero, Staten 
                        Island Landfill, and the New York City 
                        Chief Medical Examiner's Office) for 
                        any time during the period beginning on 
                        September 11, 2001, and ending on July 
                        31, 2002; or
                            (ii)(I) is a surviving immediate 
                        family member of an individual who was 
                        a member of the Fire Department of New 
                        York City (whether fire or emergency 
                        personnel, active or retired) and was 
                        killed at the World Trade site on 
                        September 11, 2001; and
                            (II) received any treatment for a 
                        WTC-related health condition described 
                        in section 3312(a)(1)(A)(ii) (relating 
                        to mental health conditions) on or 
                        before September 1, 2008.
                    (B) Law enforcement officers and wtc 
                rescue, recovery, and cleanup workers.--The 
                individual--
                            (i) worked or volunteered onsite in 
                        rescue, recovery, debris cleanup, or 
                        related support services in lower 
                        Manhattan (south of Canal St.), the 
                        Staten Island Landfill, or the barge 
                        loading piers, for at least 4 hours 
                        during the period beginning on 
                        September 11, 2001, and ending on 
                        September 14, 2001, for at least 24 
                        hours during the period beginning on 
                        September 11, 2001, and ending on 
                        September 30, 2001, or for at least 80 
                        hours during the period beginning on 
                        September 11, 2001, and ending on July 
                        31, 2002;
                            (ii)(I) was a member of the Police 
                        Department of New York City (whether 
                        active or retired) or a member of the 
                        Port Authority Police of the Port 
                        Authority of New York and New Jersey 
                        (whether active or retired) who 
                        participated onsite in rescue, 
                        recovery, debris cleanup, or related 
                        services in lower Manhattan (south of 
                        Canal St.), including Ground Zero, the 
                        Staten Island Landfill, or the barge 
                        loading piers, for at least 4 hours 
                        during the period beginning September 
                        11, 2001, and ending on September 14, 
                        2001;
                            (II) participated onsite in rescue, 
                        recovery, debris cleanup, or related 
                        services at Ground Zero, the Staten 
                        Island Landfill, or the barge loading 
                        piers, for at least one day during the 
                        period beginning on September 11, 2001, 
                        and ending on July 31, 2002;
                            (III) participated onsite in 
                        rescue, recovery, debris cleanup, or 
                        related services in lower Manhattan 
                        (south of Canal St.) for at least 24 
                        hours during the period beginning on 
                        September 11, 2001, and ending on 
                        September 30, 2001; or
                            (IV) participated onsite in rescue, 
                        recovery, debris cleanup, or related 
                        services in lower Manhattan (south of 
                        Canal St.) for at least 80 hours during 
                        the period beginning on September 11, 
                        2001, and ending on July 31, 2002;
                            (iii) was an employee of the Office 
                        of the Chief Medical Examiner of New 
                        York City involved in the examination 
                        and handling of human remains from the 
                        World Trade Center attacks, or other 
                        morgue worker who performed similar 
                        post-September 11 functions for such 
                        Office staff, during the period 
                        beginning on September 11, 2001, and 
                        ending on July 31, 2002;
                            (iv) was a worker in the Port 
                        Authority Trans-Hudson Corporation 
                        Tunnel for at least 24 hours during the 
                        period beginning on February 1, 2002, 
                        and ending on July 1, 2002; or
                            (v) was a vehicle-maintenance 
                        worker who was exposed to debris from 
                        the former World Trade Center while 
                        retrieving, driving, cleaning, 
                        repairing, and maintaining vehicles 
                        contaminated by airborne toxins from 
                        the September 11, 2001, terrorist 
                        attacks during a duration and period 
                        described in subparagraph (A).
                    (C) Responders to the september 11 attacks 
                at the pentagon and shanksville, 
                pennsylvania.--The individual--
                            (i)(I) was a member of a fire or 
                        police department (whether fire or 
                        emergency personnel, active or 
                        retired), worked for a recovery or 
                        cleanup contractor, or was a volunteer; 
                        and performed rescue, recovery, 
                        demolition, debris cleanup, or other 
                        related services at the Pentagon site 
                        of the terrorist-related aircraft crash 
                        of September 11, 2001, during the 
                        period beginning on September 11, 2001, 
                        and ending on the date on which the 
                        cleanup of the site was concluded, as 
                        determined by the WTC Program 
                        Administrator; or
                            (II) was a member of a fire or 
                        police department (whether fire or 
                        emergency personnel, active or 
                        retired), worked for a recovery or 
                        cleanup contractor, or was a volunteer; 
                        and performed rescue, recovery, 
                        demolition, debris cleanup, or other 
                        related services at the Shanksville, 
                        Pennsylvania, site of the terrorist-
                        related aircraft crash of September 11, 
                        2001, during the period beginning on 
                        September 11, 2001, and ending on the 
                        date on which the cleanup of the site 
                        was concluded, as determined by the WTC 
                        Program Administrator; and
                            (ii) is determined by the WTC 
                        Program Administrator to be at an 
                        increased risk of developing a WTC-
                        related health condition as a result of 
                        exposure to airborne toxins, other 
                        hazards, or adverse conditions 
                        resulting from the September 11, 2001, 
                        terrorist attacks, and meets such 
                        eligibility criteria related to such 
                        exposures, as the WTC Program 
                        Administrator determines are 
                        appropriate, after consultation with 
                        the WTC Scientific/Technical Advisory 
                        Committee.
            (3) Enrollment process.--
                    (A) In general.--The WTC Program 
                Administrator shall establish a process for 
                enrolling WTC responders in the WTC Program. 
                Under such process--
                            (i) WTC responders described in 
                        paragraph (1)(A) shall be deemed to be 
                        enrolled in such Program;
                            (ii) subject to clause (iii), the 
                        Administrator shall enroll in such 
                        program individuals who are determined 
                        to be WTC responders;
                            (iii) the Administrator shall deny 
                        such enrollment to an individual if the 
                        Administrator determines that the 
                        numerical limitation in paragraph (4) 
                        on enrollment of WTC responders has 
                        been met;
                            (iv) there shall be no fee charged 
                        to the applicant for making an 
                        application for such enrollment;
                            (v) the Administrator shall make a 
                        determination on such an application 
                        not later than 60 days after the date 
                        of filing the application; and
                            (vi) an individual who is denied 
                        enrollment in such Program shall have 
                        an opportunity to appeal such 
                        determination in a manner established 
                        under such process.
                    (B) Timing.--
                            (i) Currently identified 
                        responders.--In accordance with 
                        subparagraph (A)(i), the WTC Program 
                        Administrator shall enroll an 
                        individual described in paragraph 
                        (1)(A) in the WTC Program not later 
                        than July 1, 2011.
                            (ii) Other responders.--In 
                        accordance with subparagraph (A)(ii) 
                        and consistent with paragraph (4), the 
                        WTC Program Administrator shall enroll 
                        any other individual who is determined 
                        to be a WTC responder in the WTC 
                        Program at the time of such 
                        determination.
            (4) Numerical limitation on eligible wtc 
        responders.--
                    (A) In general.--The total number of 
                individuals not described in paragraph (1)(A) 
                or (2)(A)(ii) who may be enrolled under 
                paragraph (3)(A)(ii) shall not exceed 25,000 at 
                any time, of which no more than 2,500 may be 
                individuals enrolled based on modified 
                eligibility criteria established under 
                paragraph (1)(C).
                    (B) Process.--In implementing subparagraph 
                (A), the WTC Program Administrator shall--
                            (i) limit the number of enrollments 
                        made under paragraph (3)--
                                    (I) in accordance with such 
                                subparagraph; and
                                    (II) to such number, as 
                                determined by the Administrator 
                                based on the best available 
                                information and subject to 
                                amounts available under section 
                                3351, that will ensure 
                                sufficient funds will be 
                                available to provide treatment 
                                and monitoring benefits under 
                                this title, with respect to all 
                                individuals who are enrolled 
                                through the end of fiscal year 
                                2020; and
                            (ii) provide priority (subject to 
                        paragraph (3)(A)(i)) in such 
                        enrollments in the order in which 
                        individuals apply for enrollment under 
                        paragraph (3).
            (5) Disqualification of individuals on terrorist 
        watch list.--No individual who is on the terrorist 
        watch list maintained by the Department of Homeland 
        Security shall qualify as an eligible WTC responder. 
        Before enrolling any individual as a WTC responder in 
        the WTC Program under paragraph (3), the Administrator, 
        in consultation with the Secretary of Homeland 
        Security, shall determine whether the individual is on 
        such list.
    (b) Monitoring Benefits.--
            (1) In general.--In the case of an enrolled WTC 
        responder (other than one described in subsection 
        (a)(2)(A)(ii)), the WTC Program shall provide for 
        monitoring benefits that include monitoring consistent 
        with protocols approved by the WTC Program 
        Administrator and including clinical examinations and 
        long-term health monitoring and analysis. In the case 
        of an enrolled WTC responder who is an active member of 
        the Fire Department of New York City, the responder 
        shall receive such benefits as part of the individual's 
        periodic company medical exams.
            (2) Provision of monitoring benefits.--The 
        monitoring benefits under paragraph (1) shall be 
        provided through the Clinical Center of Excellence for 
        the type of individual involved or, in the case of an 
        individual residing outside the New York metropolitan 
        area, under an arrangement under section 3313.

SEC. 3312. TREATMENT OF ENROLLED WTC RESPONDERS FOR WTC-RELATED HEALTH 
                    CONDITIONS.

    (a) WTC-Related Health Condition Defined.--
            (1) In general.--For purposes of this title, the 
        term ``WTC-related health condition'' means a condition 
        that--
                    (A)(i) is an illness or health condition 
                for which exposure to airborne toxins, any 
                other hazard, or any other adverse condition 
                resulting from the September 11, 2001, 
                terrorist attacks, based on an examination by a 
                medical professional with experience in 
                treating or diagnosing the health conditions 
                included in the applicable list of WTC-related 
                health conditions, is substantially likely to 
                be a significant factor in aggravating, 
                contributing to, or causing the illness or 
                health condition, as determined under paragraph 
                (2); or
                    (ii) is a mental health condition for which 
                such attacks, based on an examination by a 
                medical professional with experience in 
                treating or diagnosing the health conditions 
                included in the applicable list of WTC-related 
                health conditions, is substantially likely to 
                be a significant factor in aggravating, 
                contributing to, or causing the condition, as 
                determined under paragraph (2); and
                    (B) is included in the applicable list of 
                WTC-related health conditions or--
                            (i) with respect to a WTC 
                        responder, is provided certification of 
                        coverage under subsection 
                        (b)(2)(B)(iii); or
                            (ii) with respect to a screening-
                        eligible WTC survivor or certified-
                        eligible WTC survivor, is provided 
                        certification of coverage under 
                        subsection (b)(2)(B)(iii), as applied 
                        under section 3322(a).
        In the case of a WTC responder described in section 
        3311(a)(2)(A)(ii) (relating to a surviving immediate 
        family member of a firefighter), such term does not 
        include an illness or health condition described in 
        subparagraph (A)(i).
            (2) Determination.--The determination under 
        paragraph (1) or subsection (b) of whether the 
        September 11, 2001, terrorist attacks were 
        substantially likely to be a significant factor in 
        aggravating, contributing to, or causing an 
        individual's illness or health condition shall be made 
        based on an assessment of the following:
                    (A) The individual's exposure to airborne 
                toxins, any other hazard, or any other adverse 
                condition resulting from the terrorist attacks. 
                Such exposure shall be--
                            (i) evaluated and characterized 
                        through the use of a standardized, 
                        population-appropriate questionnaire 
                        approved by the Director of the 
                        National Institute for Occupational 
                        Safety and Health; and
                            (ii) assessed and documented by a 
                        medical professional with experience in 
                        treating or diagnosing health 
                        conditions included on the list of WTC-
                        related health conditions.
                    (B) The type of symptoms and temporal 
                sequence of symptoms. Such symptoms shall be--
                            (i) assessed through the use of a 
                        standardized, population-appropriate 
                        medical questionnaire approved by the 
                        Director of the National Institute for 
                        Occupational Safety and Health and a 
                        medical examination; and
                            (ii) diagnosed and documented by a 
                        medical professional described in 
                        subparagraph (A)(ii).
            (3) List of health conditions for wtc responders.--
        The list of health conditions for WTC responders 
        consists of the following:
                    (A) Aerodigestive disorders.--
                            (i) Interstitial lung diseases.
                            (ii) Chronic respiratory disorder--
                        fumes/vapors.
                            (iii) Asthma.
                            (iv) Reactive airways dysfunction 
                        syndrome (RADS).
                            (v) WTC-exacerbated chronic 
                        obstructive pulmonary disease (COPD).
                            (vi) Chronic cough syndrome.
                            (vii) Upper airway hyperreactivity.
                            (viii) Chronic rhinosinusitis.
                            (ix) Chronic nasopharyngitis.
                            (x) Chronic laryngitis.
                            (xi) Gastroesophageal reflux 
                        disorder (GERD).
                            (xii) Sleep apnea exacerbated by or 
                        related to a condition described in a 
                        previous clause.
                    (B) Mental health conditions.--
                            (i) Posttraumatic stress disorder 
                        (PTSD).
                            (ii) Major depressive disorder.
                            (iii) Panic disorder.
                            (iv) Generalized anxiety disorder.
                            (v) Anxiety disorder (not otherwise 
                        specified).
                            (vi) Depression (not otherwise 
                        specified).
                            (vii) Acute stress disorder.
                            (viii) Dysthymic disorder.
                            (ix) Adjustment disorder.
                            (x) Substance abuse.
                    (C) Musculoskeletal disorders for certain 
                wtc responders.--In the case of a WTC responder 
                described in paragraph (4), a condition 
                described in such paragraph.
                    (D) Additional conditions.--Any cancer (or 
                type of cancer) or other condition added, 
                pursuant to paragraph (5) or (6), to the list 
                under this paragraph.
            (4) Musculoskeletal disorders.--
                    (A) In general.--For purposes of this 
                title, in the case of a WTC responder who 
                received any treatment for a WTC-related 
                musculoskeletal disorder on or before September 
                11, 2003, the list of health conditions in 
                paragraph (3) shall include:
                            (i) Low back pain.
                            (ii) Carpal tunnel syndrome (CTS).
                            (iii) Other musculoskeletal 
                        disorders.
                    (B) Definition.--The term ``WTC-related 
                musculoskeletal disorder'' means a chronic or 
                recurrent disorder of the musculoskeletal 
                system caused by heavy lifting or repetitive 
                strain on the joints or musculoskeletal system 
                occurring during rescue or recovery efforts in 
                the New York City disaster area in the 
                aftermath of the September 11, 2001, terrorist 
                attacks.
            (5) Cancer.--
                    (A) In general.--The WTC Program 
                Administrator shall periodically conduct a 
                review of all available scientific and medical 
                evidence, including findings and 
                recommendations of Clinical Centers of 
                Excellence, published in peer-reviewed journals 
                to determine if, based on such evidence, cancer 
                or a certain type of cancer should be added to 
                the applicable list of WTC-related health 
                conditions. The WTC Program Administrator shall 
                conduct the first review under this 
                subparagraph not later than 180 days after the 
                date of the enactment of this title.
                    (B) Proposed regulations and rulemaking.--
                Based on the periodic reviews under 
                subparagraph (A), if the WTC Program 
                Administrator determines that cancer or a 
                certain type of cancer should be added to such 
                list of WTC-related health conditions, the WTC 
                Program Administrator shall propose 
                regulations, through rulemaking, to add cancer 
                or the certain type of cancer to such list.
                    (C) Final regulations.--Based on all the 
                available evidence in the rulemaking record, 
                the WTC Program Administrator shall make a 
                final determination of whether cancer or a 
                certain type of cancer should be added to such 
                list of WTC-related health conditions. If such 
                a determination is made to make such an 
                addition, the WTC Program Administrator shall 
                by regulation add cancer or the certain type of 
                cancer to such list.
                    (D) Determinations not to add cancer or 
                certain types of cancer.--In the case that the 
                WTC Program Administrator determines under 
                subparagraph (B) or (C) that cancer or a 
                certain type of cancer should not be added to 
                such list of WTC-related health conditions, the 
                WTC Program Administrator shall publish an 
                explanation for such determination in the 
                Federal Register. Any such determination to not 
                make such an addition shall not preclude the 
                addition of cancer or the certain type of 
                cancer to such list at a later date.
            (6) Addition of health conditions to list for wtc 
        responders.--
                    (A) In general.--Whenever the WTC Program 
                Administrator determines that a proposed rule 
                should be promulgated to add a health condition 
                to the list of health conditions in paragraph 
                (3), the Administrator may request a 
                recommendation of the Advisory Committee or may 
                publish such a proposed rule in the Federal 
                Register in accordance with subparagraph (D).
                    (B) Administrator's options after receipt 
                of petition.--In the case that the WTC Program 
                Administrator receives a written petition by an 
                interested party to add a health condition to 
                the list of health conditions in paragraph (3), 
                not later than 60 days after the date of 
                receipt of such petition the Administrator 
                shall--
                            (i) request a recommendation of the 
                        Advisory Committee;
                            (ii) publish a proposed rule in the 
                        Federal Register to add such health 
                        condition, in accordance with 
                        subparagraph (D);
                            (iii) publish in the Federal 
                        Register the Administrator's 
                        determination not to publish such a 
                        proposed rule and the basis for such 
                        determination; or
                            (iv) publish in the Federal 
                        Register a determination that 
                        insufficient evidence exists to take 
                        action under clauses (i) through (iii).
                    (C) Action by advisory committee.--In the 
                case that the Administrator requests a 
                recommendation of the Advisory Committee under 
                this paragraph, with respect to adding a health 
                condition to the list in paragraph (3), the 
                Advisory Committee shall submit to the 
                Administrator such recommendation not later 
                than 60 days after the date of such request or 
                by such date (not to exceed 180 days after such 
                date of request) as specified by the 
                Administrator. Not later than 60 days after the 
                date of receipt of such recommendation, the 
                Administrator shall, in accordance with 
                subparagraph (D), publish in the Federal 
                Register a proposed rule with respect to such 
                recommendation or a determination not to 
                propose such a proposed rule and the basis for 
                such determination.
                    (D) Publication.--The WTC Program 
                Administrator shall, with respect to any 
                proposed rule under this paragraph--
                            (i) publish such proposed rule in 
                        accordance with section 553 of title 5, 
                        United States Code; and
                            (ii) provide interested parties a 
                        period of 30 days after such 
                        publication to submit written comments 
                        on the proposed rule.
                The WTC Program Administrator may extend the 
                period described in clause (ii) upon a finding 
                of good cause. In the case of such an 
                extension, the Administrator shall publish such 
                extension in the Federal Register.
                    (E) Interested party defined.--For purposes 
                of this paragraph, the term ``interested 
                party'' includes a representative of any 
                organization representing WTC responders, a 
                nationally recognized medical association, a 
                Clinical or Data Center, a State or political 
                subdivision, or any other interested person.
    (b) Coverage of Treatment for WTC-Related Health 
Conditions.--
            (1) Determination for enrolled wtc responders based 
        on a wtc-related health condition.--
                    (A) In general.--If a physician at a 
                Clinical Center of Excellence that is providing 
                monitoring benefits under section 3311 for an 
                enrolled WTC responder makes a determination 
                that the responder has a WTC-related health 
                condition that is in the list in subsection 
                (a)(3) and that exposure to airborne toxins, 
                other hazards, or adverse conditions resulting 
                from the September 1, 2001, terrorist attacks 
                is substantially likely to be a significant 
                factor in aggravating, contributing to, or 
                causing the condition--
                            (i) the physician shall promptly 
                        transmit such determination to the WTC 
                        Program Administrator and provide the 
                        Administrator with the medical facts 
                        supporting such determination; and
                            (ii) on and after the date of such 
                        transmittal and subject to subparagraph 
                        (B), the WTC Program shall provide for 
                        payment under subsection (c) for 
                        medically necessary treatment for such 
                        condition.
                    (B) Review; certification; appeals.--
                            (i) Review.--A Federal employee 
                        designated by the WTC Program 
                        Administrator shall review 
                        determinations made under subparagraph 
                        (A).
                            (ii) Certification.--The 
                        Administrator shall provide a 
                        certification of such condition based 
                        upon reviews conducted under clause 
                        (i). Such a certification shall be 
                        provided unless the Administrator 
                        determines that the responder's 
                        condition is not a WTC-related health 
                        condition in the list in subsection 
                        (a)(3) or that exposure to airborne 
                        toxins, other hazards, or adverse 
                        conditions resulting from the September 
                        1, 2001, terrorist attacks is not 
                        substantially likely to be a 
                        significant factor in aggravating, 
                        contributing to, or causing the 
                        condition.
                            (iii) Appeal process.--The 
                        Administrator shall establish, by rule, 
                        a process for the appeal of 
                        determinations under clause (ii).
            (2) Determination based on medically associated 
        wtc-related health conditions.--
                    (A) In general.--If a physician at a 
                Clinical Center of Excellence determines 
                pursuant to subsection (a) that the enrolled 
                WTC responder has a health condition described 
                in subsection (a)(1)(A) that is not in the list 
                in subsection (a)(3) but which is medically 
                associated with a WTC-related health 
                condition--
                            (i) the physician shall promptly 
                        transmit such determination to the WTC 
                        Program Administrator and provide the 
                        Administrator with the facts supporting 
                        such determination; and
                            (ii) the Administrator shall make a 
                        determination under subparagraph (B) 
                        with respect to such physician's 
                        determination.
                    (B) Procedures for review, certification, 
                and appeal.--The WTC Program Administrator 
                shall, by rule, establish procedures for the 
                review and certification of physician 
                determinations under subparagraph (A). Such 
                rule shall provide for--
                            (i) the timely review of such a 
                        determination by a physician panel with 
                        appropriate expertise for the condition 
                        and recommendations to the WTC Program 
                        Administrator;
                            (ii) not later than 60 days after 
                        the date of the transmittal under 
                        subparagraph (A)(i), a determination by 
                        the WTC Program Administrator on 
                        whether or not the condition involved 
                        is described in subsection (a)(1)(A) 
                        and is medically associated with a WTC-
                        related health condition;
                            (iii) certification in accordance 
                        with paragraph (1)(B)(ii) of coverage 
                        of such condition if determined to be 
                        described in subsection (a)(1)(A) and 
                        medically associated with a WTC-related 
                        health condition; and
                            (iv) a process for appeals of 
                        determinations relating to such 
                        conditions.
                    (C) Inclusion in list of health 
                conditions.--If the WTC Program Administrator 
                provides certification under subparagraph 
                (B)(iii) for coverage of a condition, the 
                Administrator may, pursuant to subsection 
                (a)(6), add the condition to the list in 
                subsection (a)(3).
                    (D) Conditions already declined for 
                inclusion in list.--If the WTC Program 
                Administrator publishes a determination under 
                subsection (a)(6)(B) not to include a condition 
                in the list in subsection (a)(3), the WTC 
                Program Administrator shall not provide 
                certification under subparagraph (B)(iii) for 
                coverage of the condition. In the case of an 
                individual who is certified under subparagraph 
                (B)(iii) with respect to such condition before 
                the date of the publication of such 
                determination the previous sentence shall not 
                apply.
            (3) Requirement of medical necessity.--
                    (A) In general.--In providing treatment for 
                a WTC-related health condition, a physician or 
                other provider shall provide treatment that is 
                medically necessary and in accordance with 
                medical treatment protocols established under 
                subsection (d).
                    (B) Regulations relating to medical 
                necessity.--For the purpose of this title, the 
                WTC Program Administrator shall issue 
                regulations specifying a standard for 
                determining medical necessity with respect to 
                health care services and prescription 
                pharmaceuticals, a process for determining 
                whether treatment furnished and pharmaceuticals 
                prescribed under this title meet such standard 
                (including any prior authorization 
                requirement), and a process for appeal of a 
                determination under subsection (c)(3).
            (4) Scope of treatment covered.--
                    (A) In general.--The scope of treatment 
                covered under this subsection includes services 
                of physicians and other health care providers, 
                diagnostic and laboratory tests, prescription 
                drugs, inpatient and outpatient hospital 
                services, and other medically necessary 
                treatment.
                    (B) Pharmaceutical coverage.--With respect 
                to ensuring coverage of medically necessary 
                outpatient prescription drugs, such drugs shall 
                be provided, under arrangements made by the WTC 
                Program Administrator, directly through 
                participating Clinical Centers of Excellence or 
                through one or more outside vendors.
                    (C) Transportation expenses for nationwide 
                network.--The WTC Program Administrator may 
                provide for necessary and reasonable 
                transportation and expenses incident to the 
                securing of medically necessary treatment 
                through the nationwide network under section 
                3313 involving travel of more than 250 miles 
                and for which payment is made under this 
                section in the same manner in which individuals 
                may be furnished necessary and reasonable 
                transportation and expenses incident to 
                services involving travel of more than 250 
                miles under regulations implementing section 
                3629(c) of the Energy Employees Occupational 
                Illness Compensation Program Act of 2000 (title 
                XXXVI of Public Law 106-398; 42 U.S.C. 
                7384t(c)).
            (5) Provision of treatment pending certification.--
        With respect to an enrolled WTC responder for whom a 
        determination is made by an examining physician under 
        paragraph (1) or (2), but for whom the WTC Program 
        Administrator has not yet determined whether to certify 
        the determination, the WTC Program Administrator may 
        establish by rule a process through which the 
        Administrator may approve the provision of medical 
        treatment under this subsection (and payment under 
        subsection (c)) with respect to such responder and such 
        responder's WTC-related health condition (under such 
        terms and conditions as the Administrator may provide) 
        until the Administrator makes a decision on whether to 
        certify the determination.
    (c) Payment for Initial Health Evaluation, Monitoring, and 
Treatment of WTC-Related Health Conditions.--
            (1) Medical treatment.--
                    (A) Use of feca payment rates.--
                            (i) In general.--Subject to clause 
                        (ii):
                                    (I) Subject to 
                                subparagraphs (B) and (C), the 
                                WTC Program Administrator shall 
                                reimburse costs for medically 
                                necessary treatment under this 
                                title for WTC-related health 
                                conditions according to the 
                                payment rates that would apply 
                                to the provision of such 
                                treatment and services by the 
                                facility under the Federal 
                                Employees Compensation Act.
                                    (II) For treatment not 
                                covered under subclause (i) or 
                                subparagraph (B), the WTC 
                                Program Administrator shall 
                                establish by regulation a 
                                reimbursement rate for such 
                                treatment.
                            (ii) Exception.--In no case shall 
                        payments for products or services under 
                        clause (i) be made at a rate higher 
                        than the Office of Worker's 
                        Compensation Programs in the Department 
                        Labor would pay for such products or 
                        services rendered at the time such 
                        products or services were provided.
                    (B) Pharmaceuticals.--
                            (i) In general.--The WTC Program 
                        Administrator shall establish a program 
                        for paying for the medically necessary 
                        outpatient prescription pharmaceuticals 
                        prescribed under this title for WTC-
                        related health conditions through one 
                        or more contracts with outside vendors.
                            (ii) Competitive bidding.--Under 
                        such program the Administrator shall--
                                    (I) select one or more 
                                appropriate vendors through a 
                                Federal competitive bid 
                                process; and
                                    (II) select the lowest 
                                bidder (or bidders) meeting the 
                                requirements for providing 
                                pharmaceutical benefits for 
                                participants in the WTC 
                                Program.
                            (iii) Treatment of fdny 
                        participants.--Under such program the 
                        Administrator may enter into an 
                        agreement with a separate vendor to 
                        provide pharmaceutical benefits to 
                        enrolled WTC responders for whom the 
                        Clinical Center of Excellence is 
                        described in section 3305 if such an 
                        arrangement is deemed necessary and 
                        beneficial to the program by the WTC 
                        Program Administrator.
                            (iv) Pharmaceuticals.--Not later 
                        than July 1, 2011, the Comptroller 
                        General of the United States shall 
                        submit to the Committee on Energy and 
                        Commerce of the House of 
                        Representatives and the Committee on 
                        Health, Education, Labor, and Pensions 
                        of the Senate a report on whether 
                        existing Federal pharmaceutical 
                        purchasing programs can provide 
                        pharmaceutical benefits more 
                        efficiently and effectively than 
                        through the WTC program.
                    (C) Improving quality and efficiency 
                through modification of payment amounts and 
                methodologies.--The WTC Program Administrator 
                may modify the amounts and methodologies for 
                making payments for initial health evaluations, 
                monitoring, or treatment, if, taking into 
                account utilization and quality data furnished 
                by the Clinical Centers of Excellence under 
                section 3305(b)(1)(B)(iii), the Administrator 
                determines that a bundling, capitation, pay for 
                performance, or other payment methodology would 
                better ensure high quality and efficient 
                delivery of initial health evaluations, 
                monitoring, or treatment to an enrolled WTC 
                responder, screening-eligible WTC survivor, or 
                certified-eligible WTC survivor.
            (2) Monitoring and initial health evaluation.--The 
        WTC Program Administrator shall reimburse the costs of 
        monitoring and the costs of an initial health 
        evaluation provided under this title at a rate set by 
        the Administrator by regulation.
            (3) Determination of medical necessity.--
                    (A) Review of medical necessity and 
                protocols.--As part of the process for 
                reimbursement or payment under this subsection, 
                the WTC Program Administrator shall provide for 
                the review of claims for reimbursement or 
                payment for the provision of medical treatment 
                to determine if such treatment is medically 
                necessary and in accordance with medical 
                treatment protocols established under 
                subsection (d).
                    (B) Withholding of payment for medically 
                unnecessary treatment.--The Administrator shall 
                withhold such reimbursement or payment for 
                treatment that the Administrator determines is 
                not medically necessary or is not in accordance 
                with such medical treatment protocols.
    (d) Medical Treatment Protocols.--
            (1) Development.--The Data Centers shall develop 
        medical treatment protocols for the treatment of 
        enrolled WTC responders and certified-eligible WTC 
        survivors for health conditions included in the 
        applicable list of WTC-related health conditions.
            (2) Approval.--The medical treatment protocols 
        developed under paragraph (1) shall be subject to 
        approval by the WTC Program Administrator.

SEC. 3313. NATIONAL ARRANGEMENT FOR BENEFITS FOR ELIGIBLE INDIVIDUALS 
                    OUTSIDE NEW YORK.

    (a) In General.--In order to ensure reasonable access to 
benefits under this subtitle for individuals who are enrolled 
WTC responders, screening-eligible WTC survivors, or certified-
eligible WTC survivors and who reside in any State, as defined 
in section 2(f), outside the New York metropolitan area, the 
WTC Program Administrator shall establish a nationwide network 
of health care providers to provide monitoring and treatment 
benefits and initial health evaluations near such individuals' 
areas of residence in such States. Nothing in this subsection 
shall be construed as preventing such individuals from being 
provided such monitoring and treatment benefits or initial 
health evaluation through any Clinical Center of Excellence.
    (b) Network Requirements.--Any health care provider 
participating in the network under subsection (a) shall--
            (1) meet criteria for credentialing established by 
        the Data Centers;
            (2) follow the monitoring, initial health 
        evaluation, and treatment protocols developed under 
        section 3305(a)(2)(A)(ii);
            (3) collect and report data in accordance with 
        section 3304; and
            (4) meet such fraud, quality assurance, and other 
        requirements as the WTC Program Administrator 
        establishes, including sections 1128 through 1128E of 
        the Social Security Act, as applied by section 3301(d).
    (c) Training and Technical Assistance.--The WTC Program 
Administer may provide, including through contract, for the 
provision of training and technical assistance to health care 
providers participating in the network under subsection (a).
    (d) Provision of Services Through the VA.--
            (1) In general.--The WTC Program Administrator may 
        enter into an agreement with the Secretary of Veterans 
        Affairs for the Secretary to provide services under 
        this section through facilities of the Department of 
        Veterans Affairs.
            (2) National program.--Not later than July 1, 2011, 
        the Comptroller General of the United States shall 
        submit to the Committee on Energy and Commerce of the 
        House of Representatives and the Committee on Health, 
        Education, Labor, and Pensions of the Senate a report 
        on whether the Department of Veterans Affairs can 
        provide monitoring and treatment services to 
        individuals under this section more efficiently and 
        effectively than through the nationwide network to be 
        established under subsection (a).

                         PART 2--WTC SURVIVORS

SEC. 3321. IDENTIFICATION AND INITIAL HEALTH EVALUATION OF SCREENING-
                    ELIGIBLE AND CERTIFIED-ELIGIBLE WTC SURVIVORS.

    (a) Identification of Screening-Eligible WTC Survivors and 
Certified-Eligible WTC Survivors.--
            (1) Screening-eligible wtc survivors.--
                    (A) Definition.--In this title, the term 
                ``screening-eligible WTC survivor'' means, 
                subject to subparagraph (C) and paragraph (3), 
                an individual who is described in any of the 
                following clauses:
                            (i) Currently identified 
                        survivor.--An individual, including a 
                        WTC responder, who has been identified 
                        as eligible for medical treatment and 
                        monitoring by the WTC Environmental 
                        Health Center as of the date of 
                        enactment of this title.
                            (ii) Survivor who meets current 
                        eligibility criteria.--An individual 
                        who is not a WTC responder, for 
                        purposes of the initial health 
                        evaluation under subsection (b), claims 
                        symptoms of a WTC-related health 
                        condition and meets any of the current 
                        eligibility criteria described in 
                        subparagraph (B).
                            (iii) Survivor who meets modified 
                        eligibility criteria.--An individual 
                        who is not a WTC responder, for 
                        purposes of the initial health 
                        evaluation under subsection (b), claims 
                        symptoms of a WTC-related health 
                        condition and meets such eligibility 
                        criteria relating to exposure to 
                        airborne toxins, other hazards, or 
                        adverse conditions resulting from the 
                        September 11, 2001, terrorist attacks 
                        as the WTC Administrator determines, 
                        after consultation with the Data 
                        Centers described in section 3305 and 
                        the WTC Scientific/Technical Advisory 
                        Committee and WTC Health Program 
                        Steering Committees under section 3302.
                The Administrator shall not modify such 
                criteria under clause (iii) on or after the 
                date that the number of certifications for 
                certified-eligible WTC survivors under 
                paragraph (2)(B) has reached 80 percent of the 
                limit described in paragraph (3) or on or after 
                the date that the number of enrollments of WTC 
                responders has reached 80 percent of the limit 
                described in section 3311(a)(4).
                    (B) Current eligibility criteria.--The 
                eligibility criteria described in this 
                subparagraph for an individual are that the 
                individual is described in any of the following 
                clauses:
                            (i) A person who was present in the 
                        New York City disaster area in the dust 
                        or dust cloud on September 11, 2001.
                            (ii) A person who worked, resided, 
                        or attended school, childcare, or adult 
                        daycare in the New York City disaster 
                        area for--
                                    (I) at least 4 days during 
                                the 4-month period beginning on 
                                September 11, 2001, and ending 
                                on January 10, 2002; or
                                    (II) at least 30 days 
                                during the period beginning on 
                                September 11, 2001, and ending 
                                on July 31, 2002.
                            (iii) Any person who worked as a 
                        cleanup worker or performed maintenance 
                        work in the New York City disaster area 
                        during the 4-month period described in 
                        subparagraph (B)(i) and had extensive 
                        exposure to WTC dust as a result of 
                        such work.
                            (iv) A person who was deemed 
                        eligible to receive a grant from the 
                        Lower Manhattan Development Corporation 
                        Residential Grant Program, who 
                        possessed a lease for a residence or 
                        purchased a residence in the New York 
                        City disaster area, and who resided in 
                        such residence during the period 
                        beginning on September 11, 2001, and 
                        ending on May 31, 2003.
                            (v) A person whose place of 
                        employment--
                                    (I) at any time during the 
                                period beginning on September 
                                11, 2001, and ending on May 31, 
                                2003, was in the New York City 
                                disaster area; and
                                    (II) was deemed eligible to 
                                receive a grant from the Lower 
                                Manhattan Development 
                                Corporation WTC Small Firms 
                                Attraction and Retention Act 
                                program or other government 
                                incentive program designed to 
                                revitalize the lower Manhattan 
                                economy after the September 11, 
                                2001, terrorist attacks.
                    (C) Application and determination process 
                for screening eligibility.--
                            (i) In general.--The WTC Program 
                        Administrator in consultation with the 
                        Data Centers shall establish a process 
                        for individuals, other than individuals 
                        described in subparagraph (A)(i), to be 
                        determined to be screening-eligible WTC 
                        survivors. Under such process--
                                    (I) there shall be no fee 
                                charged to the applicant for 
                                making an application for such 
                                determination;
                                    (II) the Administrator 
                                shall make a determination on 
                                such an application not later 
                                than 60 days after the date of 
                                filing the application;
                                    (III) the Administrator 
                                shall make such a determination 
                                relating to an applicant's 
                                compliance with this title and 
                                shall not determine that an 
                                individual is not so eligible 
                                or deny written documentation 
                                under clause (ii) to such 
                                individual unless the 
                                Administrator determines that--
                                            (aa) based on the 
                                        application submitted, 
                                        the individual does not 
                                        meet the eligibility 
                                        criteria; or
                                            (bb) the numerical 
                                        limitation on 
                                        certifications of 
                                        certified-eligible WTC 
                                        survivors set forth in 
                                        paragraph (3) has been 
                                        met; and
                                    (IV) an individual who is 
                                determined not to be a 
                                screening-eligible WTC survivor 
                                shall have an opportunity to 
                                appeal such determination in a 
                                manner established under such 
                                process.
                            (ii) Written documentation of 
                        screening-eligibility.--
                                    (I) In general.--In the 
                                case of an individual who is 
                                described in subparagraph 
                                (A)(i) or who is determined 
                                under clause (i) (consistent 
                                with paragraph (3)) to be a 
                                screening-eligible WTC 
                                survivor, the WTC Program 
                                Administrator shall provide an 
                                appropriate written 
                                documentation of such fact.
                                    (II) Timing.--
                                            (aa) Currently 
                                        identified survivors.--
                                        In the case of an 
                                        individual who is 
                                        described in 
                                        subparagraph (A)(i), 
                                        the WTC Program 
                                        Administrator shall 
                                        provide the written 
                                        documentation under 
                                        subclause (I) not later 
                                        than July 1, 2011.
                                            (bb) Other 
                                        members.--In the case 
                                        of another individual 
                                        who is determined under 
                                        clause (i) and 
                                        consistent with 
                                        paragraph (3) to be a 
                                        screening-eligible WTC 
                                        survivor, the WTC 
                                        Program Administrator 
                                        shall provide the 
                                        written documentation 
                                        under subclause (I) at 
                                        the time of such 
                                        determination.
            (2) Certified-eligible wtc survivors.--
                    (A) Definition.--The term ``certified-
                eligible WTC survivor'' means, subject to 
                paragraph (3), a screening-eligible WTC 
                survivor who the WTC Program Administrator 
                certifies under subparagraph (B) to be eligible 
                for followup monitoring and treatment under 
                this part.
                    (B) Certification of eligibility for 
                monitoring and treatment.--
                            (i) In general.--The WTC Program 
                        Administrator shall establish a 
                        certification process under which the 
                        Administrator shall provide appropriate 
                        certification to screening-eligible WTC 
                        survivors who, pursuant to the initial 
                        health evaluation under subsection (b), 
                        are determined to be eligible for 
                        followup monitoring and treatment under 
                        this part.
                            (ii) Timing.--
                                    (I) Currently identified 
                                survivors.--In the case of an 
                                individual who is described in 
                                paragraph (1)(A)(i), the WTC 
                                Program Administrator shall 
                                provide the certification under 
                                clause (i) not later than July 
                                1, 2011.
                                    (II) Other members.--In the 
                                case of another individual who 
                                is determined under clause (i) 
                                to be eligible for followup 
                                monitoring and treatment, the 
                                WTC Program Administrator shall 
                                provide the certification under 
                                such clause at the time of such 
                                determination.
            (3) Numerical limitation on certified-eligible wtc 
        survivors.--
                    (A) In general.--The total number of 
                individuals not described in paragraph 
                (1)(A)(i) who may be certified as certified-
                eligible WTC survivors under paragraph (2)(B) 
                shall not exceed 25,000 at any time.
                    (B) Process.--In implementing subparagraph 
                (A), the WTC Program Administrator shall--
                            (i) limit the number of 
                        certifications provided under paragraph 
                        (2)(B)--
                                    (I) in accordance with such 
                                subparagraph; and
                                    (II) to such number, as 
                                determined by the Administrator 
                                based on the best available 
                                information and subject to 
                                amounts made available under 
                                section 3351, that will ensure 
                                sufficient funds will be 
                                available to provide treatment 
                                and monitoring benefits under 
                                this title, with respect to all 
                                individuals receiving such 
                                certifications through the end 
                                of fiscal year 2020; and
                            (ii) provide priority in such 
                        certifications in the order in which 
                        individuals apply for a determination 
                        under paragraph (2)(B).
            (4) Disqualification of individuals on terrorist 
        watch list.--No individual who is on the terrorist 
        watch list maintained by the Department of Homeland 
        Security shall qualify as a screening-eligible WTC 
        survivor or a certified-eligible WTC survivor. Before 
        determining any individual to be a screening-eligible 
        WTC survivor under paragraph (1) or certifying any 
        individual as a certified eligible WTC survivor under 
        paragraph (2), the Administrator, in consultation with 
        the Secretary of Homeland Security, shall determine 
        whether the individual is on such list.
    (b) Initial Health Evaluation To Determine Eligibility for 
Followup Monitoring or Treatment.--
            (1) In general.--In the case of a screening-
        eligible WTC survivor, the WTC Program shall provide 
        for an initial health evaluation to determine if the 
        survivor has a WTC-related health condition and is 
        eligible for followup monitoring and treatment benefits 
        under the WTC Program. Initial health evaluation 
        protocols under section 3305(a)(2)(A)(ii) shall be 
        subject to approval by the WTC Program Administrator.
            (2) Initial health evaluation providers.--The 
        initial health evaluation described in paragraph (1) 
        shall be provided through a Clinical Center of 
        Excellence with respect to the individual involved.
            (3) Limitation on initial health evaluation 
        benefits.--Benefits for an initial health evaluation 
        under this part for a screening-eligible WTC survivor 
        shall consist only of a single medical initial health 
        evaluation consistent with initial health evaluation 
        protocols described in paragraph (1). Nothing in this 
        paragraph shall be construed as preventing such an 
        individual from seeking additional medical initial 
        health evaluations at the expense of the individual.

SEC. 3322. FOLLOWUP MONITORING AND TREATMENT OF CERTIFIED-ELIGIBLE WTC 
                    SURVIVORS FOR WTC-RELATED HEALTH CONDITIONS.

    (a) In General.--Subject to subsection (b), the provisions 
of sections 3311 and 3312 shall apply to followup monitoring 
and treatment of WTC-related health conditions for certified-
eligible WTC survivors in the same manner as such provisions 
apply to the monitoring and treatment of WTC-related health 
conditions for enrolled WTC responders.
    (b) List of WTC-Related Health Conditions for Survivors.--
The list of health conditions for screening-eligible WTC 
survivors and certified-eligible WTC survivors consists of the 
following:
            (1) Aerodigestive disorders.--
                    (A) Interstitial lung diseases.
                    (B) Chronic respiratory disorder--fumes/
                vapors.
                    (C) Asthma.
                    (D) Reactive airways dysfunction syndrome 
                (RADS).
                    (E) WTC-exacerbated chronic obstructive 
                pulmonary disease (COPD).
                    (F) Chronic cough syndrome.
                    (G) Upper airway hyperreactivity.
                    (H) Chronic rhinosinusitis.
                    (I) Chronic nasopharyngitis.
                    (J) Chronic laryngitis.
                    (K) Gastroesophageal reflux disorder 
                (GERD).
                    (L) Sleep apnea exacerbated by or related 
                to a condition described in a previous clause.
            (2) Mental health conditions.--
                    (A) Posttraumatic stress disorder (PTSD).
                    (B) Major depressive disorder.
                    (C) Panic disorder.
                    (D) Generalized anxiety disorder.
                    (E) Anxiety disorder (not otherwise 
                specified).
                    (F) Depression (not otherwise specified).
                    (G) Acute stress disorder.
                    (H) Dysthymic disorder.
                    (I) Adjustment disorder.
                    (J) Substance abuse.
            (3) Additional conditions.--Any cancer (or type of 
        cancer) or other condition added to the list in section 
        3312(a)(3) pursuant to paragraph (5) or (6) of section 
        3312(a), as such provisions are applied under 
        subsection (a) with respect to certified-eligible WTC 
        survivors.

SEC. 3323. FOLLOWUP MONITORING AND TREATMENT OF OTHER INDIVIDUALS WITH 
                    WTC-RELATED HEALTH CONDITIONS.

    (a) In General.--Subject to subsection (c), the provisions 
of section 3322 shall apply to the followup monitoring and 
treatment of WTC-related health conditions in the case of 
individuals described in subsection (b) in the same manner as 
such provisions apply to the followup monitoring and treatment 
of WTC-related health conditions for certified-eligible WTC 
survivors.
    (b) Individuals Described.--An individual described in this 
subsection is an individual who, regardless of location of 
residence--
            (1) is not an enrolled WTC responder or a 
        certified-eligible WTC survivor; and
            (2) is diagnosed at a Clinical Center of Excellence 
        with a WTC-related health condition for certified-
        eligible WTC survivors.
    (c) Limitation.--
            (1) In general.--The WTC Program Administrator 
        shall limit benefits for any fiscal year under 
        subsection (a) in a manner so that payments under this 
        section for such fiscal year do not exceed the amount 
        specified in paragraph (2) for such fiscal year.
            (2) Limitation.--The amount specified in this 
        paragraph for--
                    (A) the last calendar quarter of fiscal 
                year 2011 is $5,000,000;
                    (B) fiscal year 2012 is $20,000,000; or
                    (C) a succeeding fiscal year is the amount 
                specified in this paragraph for the previous 
                fiscal year increased by the annual percentage 
                increase in the medical care component of the 
                consumer price index for all urban consumers.

                        PART 3--PAYOR PROVISIONS

SEC. 3331. PAYMENT OF CLAIMS.

    (a) In General.--Except as provided in subsections (b) and 
(c), the cost of monitoring and treatment benefits and initial 
health evaluation benefits provided under parts 1 and 2 of this 
subtitle shall be paid for by the WTC Program from the World 
Trade Center Health Program Fund.
    (b) Workers' Compensation Payment.--
            (1) In general.--Subject to paragraph (2), payment 
        for treatment under parts 1 and 2 of this subtitle of a 
        WTC-related health condition of an individual that is 
        work-related shall be reduced or recouped to the extent 
        that the WTC Program Administrator determines that 
        payment has been made, or can reasonably be expected to 
        be made, under a workers' compensation law or plan of 
        the United States, a State, or a locality, or other 
        work-related injury or illness benefit plan of the 
        employer of such individual, for such treatment. The 
        provisions of clauses (iii), (iv), (v), and (vi) of 
        paragraph (2)(B) of section 1862(b) of the Social 
        Security Act and paragraphs (3) and (4) of such section 
        shall apply to the recoupment under this subsection of 
        a payment to the WTC Program (with respect to a 
        workers' compensation law or plan, or other work-
        related injury or illness plan of the employer 
        involved, and such individual) in the same manner as 
        such provisions apply to the reimbursement of a payment 
        under section 1862(b)(2) of such Act to the Secretary 
        (with respect to such a law or plan and an individual 
        entitled to benefits under title XVIII of such Act) 
        except that any reference in such paragraph (4) to 
        payment rates under title XVIII of the Social Security 
        Act shall be deemed a reference to payment rates under 
        this title.
            (2) Exception.--Paragraph (1) shall not apply for 
        any quarter, with respect to any workers' compensation 
        law or plan, including line of duty compensation, to 
        which New York City is obligated to make payments, if, 
        in accordance with terms specified under the contract 
        under subsection (d)(1)(A), New York City has made the 
        full payment required under such contract for such 
        quarter.
            (3) Rules of construction.--Nothing in this title 
        shall be construed to affect, modify, or relieve any 
        obligations under a worker's compensation law or plan, 
        other work-related injury or illness benefit plan of an 
        employer, or any health insurance plan.
    (c) Health Insurance Coverage.--
            (1) In general.--In the case of an individual who 
        has a WTC-related health condition that is not work-
        related and has health coverage for such condition 
        through any public or private health plan (including 
        health benefits under title XVIII, XIX, or XXI of the 
        Social Security Act) the provisions of section 1862(b) 
        of the Social Security Act shall apply to such a health 
        plan and such individual in the same manner as they 
        apply to group health plan and an individual entitled 
        to benefits under title XVIII of such Act pursuant to 
        section 226(a) of such Act. Any costs for items and 
        services covered under such plan that are not 
        reimbursed by such health plan, due to the application 
        of deductibles, copayments, coinsurance, other cost 
        sharing, or otherwise, are reimbursable under this 
        title to the extent that they are covered under the WTC 
        Program. The program under this title shall not be 
        treated as a legally liable party for purposes of 
        applying section 1902(a)(25) of the Social Security 
        Act.
            (2) Recovery by individual providers.--Nothing in 
        paragraph (1) shall be construed as requiring an entity 
        providing monitoring and treatment under this title to 
        seek reimbursement under a health plan with which the 
        entity has no contract for reimbursement.
            (3) Maintenance of required minimum essential 
        coverage.--No payment may be made for monitoring and 
        treatment under this title for an individual for a 
        month (beginning with July 2014) if with respect to 
        such month the individual--
                    (A) is an applicable individual (as defined 
                in subsection (d) of section 5000A of Internal 
                Revenue Code of 1986) for whom the exemption 
                under subsection (e) of such section does not 
                apply; and
                    (B) is not covered under minimum essential 
                coverage, as required under subsection (a) of 
                such section.
    (d) Required Contribution by New York City in Program 
Costs.--
            (1) Contract requirement.--
                    (A) In general.--No funds may be disbursed 
                from the World Trade Center Health Program Fund 
                under section 3351 unless New York City has 
                entered into a contract with the WTC Program 
                Administrator under which New York City agrees, 
                in a form and manner specified by the 
                Administrator, to pay the full contribution 
                described in subparagraph (B) in accordance 
                with this subsection on a timely basis, plus 
                any interest owed pursuant to subparagraph 
                (E)(i). Such contract shall specify the terms 
                under which New York City shall be considered 
                to have made the full payment required for a 
                quarter for purposes of subsection (b)(2).
                    (B) Full contribution amount.--Under such 
                contract, with respect to the last calendar 
                quarter of fiscal year 2011 and each calendar 
                quarter in fiscal years 2012 through 2015 the 
                full contribution amount under this 
                subparagraph shall be equal to 10 percent of 
                the expenditures in carrying out this title for 
                the respective quarter and with respect to 
                calendar quarters in fiscal year 2016, such 
                full contribution amount shall be equal to \1/
                9\ of the Federal expenditures in carrying out 
                this title for the respective quarter.
                    (C) Satisfaction of payment obligation.--
                The payment obligation under such contract may 
                not be satisfied through any of the following:
                            (i) An amount derived from Federal 
                        sources.
                            (ii) An amount paid before the date 
                        of the enactment of this title.
                            (iii) An amount paid to satisfy a 
                        judgment or as part of a settlement 
                        related to injuries or illnesses 
                        arising out of the September 11, 2001, 
                        terrorist attacks.
                    (D) Timing of contribution.--The payment 
                obligation under such contract for a calendar 
                quarter in a fiscal year shall be paid not 
                later than the last day of the second 
                succeeding calendar quarter.
                    (E) Compliance.--
                            (i) Interest for late payment.--If 
                        New York City fails to pay to the WTC 
                        Program Administrator pursuant to such 
                        contract the amount required for any 
                        calendar quarter by the day specified 
                        in subparagraph (D), interest shall 
                        accrue on the amount not so paid at the 
                        rate (determined by the Administrator) 
                        based on the average yield to maturity, 
                        plus 1 percentage point, on outstanding 
                        municipal bonds issued by New York City 
                        with a remaining maturity of at least 1 
                        year.
                            (ii) Recovery of amounts owed.--The 
                        amounts owed to the WTC Program 
                        Administrator under such contract shall 
                        be recoverable by the United States in 
                        an action in the same manner as 
                        payments made under title XVIII of the 
                        Social Security Act may be recoverable 
                        in an action brought under section 
                        1862(b)(2)(B)(iii) of such Act.
                    (F) Deposit in fund.--The WTC Program 
                Administer shall deposit amounts paid under 
                such contract into the World Trade Center 
                Health Program Fund under section 3351.
            (2) Payment of new york city share of monitoring 
        and treatment costs.--With respect to each calendar 
        quarter for which a contribution is required by New 
        York City under the contract under paragraph (1), the 
        WTC Program Administrator shall--
                    (A) provide New York City with an estimate 
                of such amount of the required contribution at 
                the beginning of such quarter and with an 
                updated estimate of such amount at the 
                beginning of each of the subsequent 2 quarters;
                    (B) bill such amount directly to New York 
                City; and
                    (C) certify periodically, for purposes of 
                this subsection, whether or not New York City 
                has paid the amount so billed.
        Such amount shall initially be estimated by the WTC 
        Program Administrator and shall be subject to 
        adjustment and reconciliation based upon actual 
        expenditures in carrying out this title.
            (3) Rule of construction.--Nothing in this 
        subsection shall be construed as authorizing the WTC 
        Administrator, with respect to a fiscal year, to reduce 
        the numerical limitation under section 3311(a)(4) or 
        3321(a)(3) for such fiscal year if New York City fails 
        to comply with paragraph (1) for a calendar quarter in 
        such fiscal year.
    (e) Work-Related Described.--For the purposes of this 
section, a WTC-related health condition shall be treated as a 
condition that is work-related if--
            (1) the condition is diagnosed in an enrolled WTC 
        responder, or in an individual who qualifies as a 
        certified-eligible WTC survivor on the basis of being a 
        rescue, recovery, or cleanup worker; or
            (2) with respect to the condition the individual 
        has filed and had established a claim under a workers' 
        compensation law or plan of the United States or a 
        State, or other work-related injury or illness benefit 
        plan of the employer of such individual.

SEC. 3332. ADMINISTRATIVE ARRANGEMENT AUTHORITY.

    The WTC Program Administrator may enter into arrangements 
with other government agencies, insurance companies, or other 
third-party administrators to provide for timely and accurate 
processing of claims under sections 3312, 3313, 3322, and 3323.

                  Subtitle C--Research Into Conditions

SEC. 3341. RESEARCH REGARDING CERTAIN HEALTH CONDITIONS RELATED TO 
                    SEPTEMBER 11 TERRORIST ATTACKS.

    (a) In General.--With respect to individuals, including 
enrolled WTC responders and certified-eligible WTC survivors, 
receiving monitoring or treatment under subtitle B, the WTC 
Program Administrator shall conduct or support--
            (1) research on physical and mental health 
        conditions that may be related to the September 11, 
        2001, terrorist attacks;
            (2) research on diagnosing WTC-related health 
        conditions of such individuals, in the case of 
        conditions for which there has been diagnostic 
        uncertainty; and
            (3) research on treating WTC-related health 
        conditions of such individuals, in the case of 
        conditions for which there has been treatment 
        uncertainty.
The Administrator may provide such support through continuation 
and expansion of research that was initiated before the date of 
the enactment of this title and through the World Trade Center 
Health Registry (referred to in section 3342), through a 
Clinical Center of Excellence, or through a Data Center.
    (b) Types of Research.--The research under subsection 
(a)(1) shall include epidemiologic and other research studies 
on WTC-related health conditions or emerging conditions--
            (1) among enrolled WTC responders and certified-
        eligible WTC survivors under treatment; and
            (2) in sampled populations outside the New York 
        City disaster area in Manhattan as far north as 14th 
        Street and in Brooklyn, along with control populations, 
        to identify potential for long-term adverse health 
        effects in less exposed populations.
    (c) Consultation.--The WTC Program Administrator shall 
carry out this section in consultation with the WTC Scientific/
Technical Advisory Committee.
    (d) Application of Privacy and Human Subject Protections.--
The privacy and human subject protections applicable to 
research conducted under this section shall not be less than 
such protections applicable to research conducted or funded by 
the Department of Health and Human Services.

SEC. 3342. WORLD TRADE CENTER HEALTH REGISTRY.

    For the purpose of ensuring ongoing data collection 
relating to victims of the September 11, 2001, terrorist 
attacks, the WTC Program Administrator shall ensure that a 
registry of such victims is maintained that is at least as 
comprehensive as the World Trade Center Health Registry 
maintained under the arrangements in effect as of April 20, 
2009, with the New York City Department of Health and Mental 
Hygiene.

                          Subtitle D--Funding

SEC. 3351. WORLD TRADE CENTER HEALTH PROGRAM FUND.

    (a) Establishment of Fund.--
            (1) In general.--There is established a fund to be 
        known as the World Trade Center Health Program Fund 
        (referred to in this section as the ``Fund'').
            (2) Funding.--Out of any money in the Treasury not 
        otherwise appropriated, there shall be deposited into 
        the Fund for each of fiscal years 2012 through 2016 
        (and the last calendar quarter of fiscal year 2011)--
                    (A) the Federal share, consisting of an 
                amount equal to the lesser of--
                            (i) 90 percent of the expenditures 
                        in carrying out this title for the 
                        respective fiscal year (initially based 
                        on estimates, subject to subsequent 
                        reconciliation based on actual 
                        expenditures); or
                            (ii)(I) $71,000,000 for the last 
                        calendar quarter of fiscal year 2011, 
                        $318,000,000 for fiscal year 2012, 
                        $354,000,000 for fiscal year 2013, 
                        $382,000,000 for fiscal year 2014, and 
                        $431,000,000 for fiscal year 2015; and
                            (II) subject to paragraph (4), an 
                        additional amount for fiscal year 2016 
                        from unexpended amounts for previous 
                        fiscal years; plus
                    (B) the New York City share, consisting of 
                the amount contributed under the contract under 
                section 3331(d).
            (3) Contract requirement.--
                    (A) In general.--No funds may be disbursed 
                from the Fund unless New York City has entered 
                into a contract with the WTC Program 
                Administrator under section 3331(d)(1).
                    (B) Breach of contract.--In the case of a 
                failure to pay the amount so required under the 
                contract--
                            (i) the amount is recoverable under 
                        subparagraph (E)(ii) of such section;
                            (ii) such failure shall not affect 
                        the disbursement of amounts from the 
                        Fund; and
                            (iii) the Federal share described 
                        in paragraph (2)(A) shall not be 
                        increased by the amount so unpaid.
            (4) Aggregate limitation on funding beginning with 
        fiscal year 2016.--Beginning with fiscal year 2016, in 
        no case shall the share of Federal funds deposited into 
        the Fund under paragraph (2) for such fiscal year and 
        previous fiscal years and quarters exceed the sum of 
        the amounts specified in paragraph (2)(A)(ii)(I).
    (b) Mandatory Funds for Monitoring, Initial Health 
Evaluations, Treatment, and Claims Processing.--
            (1) In general.--The amounts deposited into the 
        Fund under subsection (a)(2) shall be available, 
        without further appropriation, consistent with 
        paragraph (2) and subsection (c), to carry out subtitle 
        B and sections 3302(a), 3303, 3304, 3305(a)(2), 
        3305(c), 3341, and 3342.
            (2) Limitation on mandatory funding.--This title 
        does not establish any Federal obligation for payment 
        of amounts in excess of the amounts available from the 
        Fund for such purpose.
            (3) Limitation on authorization for further 
        appropriations.--This title does not establish any 
        authorization for appropriation of amounts in excess of 
        the amounts available from the Fund under paragraph 
        (1).
    (c) Limits on Spending for Certain Purposes.--Of the 
amounts made available under subsection (b)(1), not more than 
each of the following amounts may be available for each of the 
following purposes:
            (1) Surviving immediate family members of 
        firefighters.--For the purposes of carrying out 
        subtitle B with respect to WTC responders described in 
        section 3311(a)(2)(A)(ii)--
                    (A) for the last calendar quarter of fiscal 
                year 2011, $100,000;
                    (B) for fiscal year 2012, $400,000; and
                    (C) for each subsequent fiscal year, the 
                amount specified under this paragraph for the 
                previous fiscal year increased by the 
                percentage increase in the consumer price index 
                for all urban consumers (all items; United 
                States city average) as estimated by the 
                Secretary for the 12-month period ending with 
                March of the previous year.
            (2) WTC health program scientific/technical 
        advisory committee.--For the purpose of carrying out 
        section 3302(a)--
                    (A) for the last calendar quarter of fiscal 
                year 2011, $25,000;
                    (B) for fiscal year 2012, $100,000; and
                    (C) for each subsequent fiscal year, the 
                amount specified under this paragraph for the 
                previous fiscal year increased by the 
                percentage increase in the consumer price index 
                for all urban consumers (all items; United 
                States city average) as estimated by the 
                Secretary for the 12-month period ending with 
                March of the previous year.
            (3) Education and outreach.--For the purpose of 
        carrying out section 3303--
                    (A) for the last calendar quarter of fiscal 
                year 2011, $500,000;
                    (B) for fiscal year 2012, $2,000,000; and
                    (C) for each subsequent fiscal year, the 
                amount specified under this paragraph for the 
                previous fiscal year increased by the 
                percentage increase in the consumer price index 
                for all urban consumers (all items; United 
                States city average) as estimated by the 
                Secretary for the 12-month period ending with 
                March of the previous year.
            (4) Uniform data collection.--For the purpose of 
        carrying out section 3304 and for reimbursing Data 
        Centers (as defined in section 3305(b)(2)) for the 
        costs incurred by such Centers in carrying out 
        activities under contracts entered into under section 
        3305(a)(2)--
                    (A) for the last calendar quarter of fiscal 
                year 2011, $2,500,000;
                    (B) for fiscal year 2012, $10,000,000; and
                    (C) for each subsequent fiscal year, the 
                amount specified under this paragraph for the 
                previous fiscal year increased by the 
                percentage increase in the consumer price index 
                for all urban consumers (all items; United 
                States city average) as estimated by the 
                Secretary for the 12-month period ending with 
                March of the previous year.
            (5) Research regarding certain health conditions.--
        For the purpose of carrying out section 3341--
                    (A) for the last calendar quarter of fiscal 
                year 2011, $3,750,000;
                    (B) for fiscal year 2012, $15,000,000; and
                    (C) for each subsequent fiscal year, the 
                amount specified under this paragraph for the 
                previous fiscal year increased by the 
                percentage increase in the consumer price index 
                for all urban consumers (all items; United 
                States city average) as estimated by the 
                Secretary for the 12-month period ending with 
                March of the previous year.
            (6) World trade center health registry.--For the 
        purpose of carrying out section 3342--
                    (A) for the last calendar quarter of fiscal 
                year 2011, $1,750,000;
                    (B) for fiscal year 2012, $7,000,000; and
                    (C) for each subsequent fiscal year, the 
                amount specified under this paragraph for the 
                previous fiscal year increased by the 
                percentage increase in the consumer price index 
                for all urban consumers (all items; United 
                States city average) as estimated by the 
                Secretary for the 12-month period ending with 
                March of the previous year.

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