[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 15 Reported in Senate (RS)]
Calendar No. 53
108th CONGRESS
1st Session
S. 15
To amend the Public Health Service Act to provide for the payment of
compensation for certain individuals with injuries resulting from the
administration of smallpox countermeasures, to provide protections and
countermeasures against chemical, radiological, or nuclear agents that
may be used in a terrorist attack against the United States, and to
improve immunization rates by increasing the distribution of vaccines
and improving and clarifying the vaccine injury compensation program.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 11, 2003
Mr. Gregg (for himself, Mr. Frist, Mr. Alexander, Mr. Warner, Mr. Enzi,
Mr. Sessions, Mr. Roberts, Mr. Graham of South Carolina, Mr. Bond, Mr.
Inhofe, and Mr. Stevens) introduced the following bill; which was read
twice and referred to the Committee on Health, Education, Labor, and
Pensions
March 25, 2003
Reported by Mr. Gregg, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to provide for the payment of
compensation for certain individuals with injuries resulting from the
administration of smallpox countermeasures, to provide protections and
countermeasures against chemical, radiological, or nuclear agents that
may be used in a terrorist attack against the United States, and to
improve immunization rates by increasing the distribution of vaccines
and improving and clarifying the vaccine injury compensation program.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
<DELETED>SECTION 1. SHORT TITLE; TABLE OF CONTENTS.</DELETED>
<DELETED> (a) Short Title.--This Act may be cited as the
``Biodefense Improvement and Treatment for America Act''.</DELETED>
<DELETED> (b) Table of Contents.--The table of contents of this Act
is as follows:</DELETED>
<DELETED>Sec. 1. Short title; table of contents.
<DELETED>TITLE I--PROTECTION FOR SMALLPOX EMERGENCY PERSONNEL
<DELETED>Sec. 101. Short title.
<DELETED>Sec. 102. Amendment to the Public Health Service Act.
<DELETED>TITLE II--PROJECT BIOSHIELD
<DELETED>Sec. 201. Short title.
<DELETED>Sec. 202. Biomedical countermeasure research and development
authorities.
<DELETED>Sec. 203. Biomedical countermeasures procurement.
<DELETED>Sec. 204. Authorization for medical products for use in
emergencies.
<DELETED>Sec. 205. Developing new countermeasures and protecting
existing countermeasures against
bioterrorism.
<DELETED>TITLE III--IMPROVED VACCINE AFFORDABILITY AND AVAILABILITY
<DELETED>Sec. 301. Short title.
<DELETED>Subtitle A--State Vaccine Grants
<DELETED>Sec. 311. Availability of influenza vaccine.
<DELETED>Sec. 312. Program for increasing immunization rates for adults
and adolescents; collection of additional
immunization data.
<DELETED>Sec. 313. Immunization awareness.
<DELETED>Sec. 314. Supply of vaccines.
<DELETED>Sec. 315. Communication.
<DELETED>Sec. 316. Fast track.
<DELETED>Sec. 317. Study.
<DELETED>Subtitle B--Vaccine Injury Compensation Program
<DELETED>Sec. 321. Administrative revision of vaccine injury table.
<DELETED>Sec. 322. Equitable relief.
<DELETED>Sec. 323. Derivative petitions for compensation.
<DELETED>Sec. 324. Jurisdiction to dismiss actions improperly brought.
<DELETED>Sec. 325. Clarification of when injury is caused by factor
unrelated to administration of vaccine.
<DELETED>Sec. 326. Increase in award in the case of a vaccine-related
death and for pain and suffering.
<DELETED>Sec. 327. Basis for calculating projected lost earnings.
<DELETED>Sec. 328. Allowing compensation for family counseling expenses
and expenses of establishing and
maintaining guardianship.
<DELETED>Sec. 329. Allowing payment of interim costs.
<DELETED>Sec. 330. Procedure for paying attorneys' fees.
<DELETED>Sec. 331. Extension of statute of limitations.
<DELETED>Sec. 332. Advisory Commission on Childhood Vaccines.
<DELETED>Sec. 333. Clarification of standards of responsibility.
<DELETED>Sec. 334. Clarification of definition of manufacturer.
<DELETED>Sec. 335. Clarification of definition of vaccine-related
injury or death.
<DELETED>Sec. 336. Clarification of definition of vaccine and
definition of physical injury.
<DELETED>Sec. 337. Amendments to Vaccine Injury Compensation Trust
Fund.
<DELETED>Sec. 338. Ongoing review of childhood vaccine data.
<DELETED>Sec. 339. Pending actions.
<DELETED>Sec. 340. Report.
<DELETED>TITLE I--PROTECTION FOR SMALLPOX EMERGENCY PERSONNEL</DELETED>
<DELETED>SEC. 101. SHORT TITLE.</DELETED>
<DELETED> This title may be cited as the ``Smallpox Emergency
Personnel Protection Act of 2003''.</DELETED>
<DELETED>SEC. 102. AMENDMENT TO THE PUBLIC HEALTH SERVICE
ACT.</DELETED>
<DELETED> Part A of title II of the Public Health Service Act (42
U.S.C. 202 et seq.) is amended by inserting after section 224 the
following:</DELETED>
<DELETED>``SEC. 224A. PROTECTION FOR SMALLPOX EMERGENCY
PERSONNEL.</DELETED>
<DELETED> ``(a) Definitions.--In this section:</DELETED>
<DELETED> ``(1) Covered countermeasure.--The term `covered
countermeasure' means a covered countermeasure as specified in
article III of the Declaration.</DELETED>
<DELETED> ``(2) Covered individual.--The term `covered
individual' means an individual--</DELETED>
<DELETED> ``(A) who is--</DELETED>
<DELETED> ``(i) a health care worker, a law
enforcement officer, a firefighter, a security-
related worker, an emergency medical worker, or
a public safety worker who is identified in a
State, local, or Department of Health and Human
Services plan that is approved by the
Secretary; or</DELETED>
<DELETED> ``(ii) an individual with respect
to whom the Secretary determines and declares
that it is advisable to administer the vaccine
(not including any individual to whom the
Secretary determines only that such vaccine
should be made available); and</DELETED>
<DELETED> ``(B) to whom a vaccine is administered
during the period in which the Declaration is effective
(including the portion of such period before the date
of enactment of this section) and ending on the later
of--</DELETED>
<DELETED> ``(i) the expiration of the 120-
day period that begins on the effective date of
the initial interim final regulations to
implement this section;</DELETED>
<DELETED> ``(ii) the expiration of the 120-
day period that begins on the date on which an
individual becomes an individual within a
category specified in subparagraph (A);
or</DELETED>
<DELETED> ``(iii) the date on which the
Secretary publicly announces that an active
case of smallpox has been identified either
within or outside the United States.</DELETED>
<DELETED> ``(3) Covered injury.--The term `covered injury'
includes--</DELETED>
<DELETED> ``(A) an injury, disability, illness,
condition, or death determined, pursuant to the
procedures established under subsection (b), to have
been sustained as the direct result of administration
to an individual of a covered countermeasure during the
effective period of the Declaration (other than a minor
injury such as minor scarring or minor local reaction);
and</DELETED>
<DELETED> ``(B) an injury, disability, illness,
condition, or death determined, pursuant to the
procedures established under subsection (b), to have
been sustained as the direct result of accidental
vaccinia inoculation through contact with an individual
who is (or who was accidentally inoculated by) an
individual in a category specified in Article IV of the
Declaration to whom vaccinia vaccine has been
administered during the effective period of the
Declaration.</DELETED>
<DELETED> ``(4) Declaration.--The term `Declaration' means
the Declaration Regarding Administration of Smallpox
Countermeasures issued by the Secretary of Health and Human
Services on January 24, 2003, and published in the Federal
Register on January 28, 2003, including any subsequent
amendment.</DELETED>
<DELETED> ``(5) Eligible individual.--The term `eligible
individual' means an individual who is (as determined in
accordance with section 3)--</DELETED>
<DELETED> ``(A) a covered individual who sustains a
covered injury as the direct result of administration
of a covered countermeasure; or</DELETED>
<DELETED> ``(B) any individual who contracts
vaccinia during the effective period of the Declaration
or within 30 days after the end of such period--
</DELETED>
<DELETED> ``(i) to whom vaccinia vaccine was
not administered;</DELETED>
<DELETED> ``(ii) who has resided with, or
has been in close contact with, a covered
individual; and</DELETED>
<DELETED> ``(iii) who sustains a covered
injury as the direct result of contracting
vaccinia.</DELETED>
<DELETED> ``(6) Secretary.--Except as provided otherwise,
the term `Secretary' means the Secretary of Health and Human
Services.</DELETED>
<DELETED> ``(b) Determination of Eligibility.--</DELETED>
<DELETED> ``(1) In general.--The Secretary, in consultation
with the Attorney General and the Secretary of Labor, shall
establish administrative procedures for determining, as
applicable with respect to an individual--</DELETED>
<DELETED> ``(A) whether the individual is an
eligible individual;</DELETED>
<DELETED> ``(B) whether the individual has sustained
a covered injury or injuries for which medical benefits
and employment income-loss compensation may be
available under subsections (d) and (e), and the amount
of such benefits or compensation; and</DELETED>
<DELETED> ``(C) whether the covered injury or
injuries of the individual constitute a compensable
disability, or caused the individual's death, for
purposes of benefits under subsection (f).</DELETED>
<DELETED> ``(2) 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 an individual in a category
specified in article IV of the Declaration to whom such a
countermeasure has been administered by the applicable deadline
specified in subsection (a)(2)(B), as establishing that the
individual is a covered individual.</DELETED>
<DELETED> ``(3) Determination of causation.--</DELETED>
<DELETED> ``(A) Injuries specified in injury
table.--In any case where an injury or other adverse
effect specified in the injury table established under
subsection (c) as a known effect of a covered
countermeasure manifests in an individual within the
time period specified in such table, such injury or
other effect shall be rebuttably presumed to have
resulted from administration of such covered
countermeasure.</DELETED>
<DELETED> ``(B) Other determinations.--In making
determinations other than those described in
subparagraph (A) as to the causation or severity of an
injury, the Secretary shall take into consideration all
relevant medical and scientific evidence presented for
consideration, and may obtain and consider the views of
qualified medical experts.</DELETED>
<DELETED> ``(4) Deadline for filing claim.--The Secretary
shall not consider any claim for a benefit under this
subsection with respect to an individual that is filed later
than 1 year after--</DELETED>
<DELETED> ``(A) the date a covered countermeasure
was administered to the individual; or</DELETED>
<DELETED> ``(B) in the case of a claim based on
contact vaccination (as described in subsection
(a)(5)(B)), the date of the first symptom or
manifestation of onset of an adverse effect of such
vaccination.</DELETED>
<DELETED> ``(5) Review of determination.--</DELETED>
<DELETED> ``(A) Secretary's review authority.--The
Secretary may review a determination under this
subsection at any time on the Secretary's own motion or
on application, and may affirm, vacate, or modify such
determination.</DELETED>
<DELETED> ``(B) Secretary's action not judicially
reviewable.--The determinations of the Secretary under
this subsection shall not be subject to review by
another official of the United States or by a court by
mandamus or otherwise.</DELETED>
<DELETED> ``(c) Countermeasure Injury Table.--</DELETED>
<DELETED> ``(1) Smallpox countermeasure injury table.--The
Secretary shall establish by interim final regulation a table
identifying--</DELETED>
<DELETED> ``(A) adverse effects (including injuries,
disabilities, illnesses, conditions, and deaths) that
shall be presumed to result from the administration of
(or exposure to) a covered countermeasure;
and</DELETED>
<DELETED> ``(B) the time periods in which the first
symptom, or manifestation of onset of each such adverse
effect, must manifest in order for such presumption to
apply.</DELETED>
<DELETED> ``(2) Amendments.--The Secretary may amend by
regulation the table established under paragraph (1). Such
amendments shall apply retroactively to claims filed or pending
at the time of the promulgation of final amending regulations
and to claims filed after such promulgation.</DELETED>
<DELETED> ``(d) Medical Benefits.--</DELETED>
<DELETED> ``(1) In general.--Subject to paragraph (2), an
eligible individual shall be entitled to payment by the
Secretary for medical items and services as reasonable and
necessary to treat a covered injury. The Secretary may consider
the provisions of chapter 81 of title 5, United States Code,
(and the implementing regulations with respect to such chapter)
in determining the amount of such payment and the circumstances
under which such payments are reasonable and
necessary.</DELETED>
<DELETED> ``(2) Limitations.--</DELETED>
<DELETED> ``(A) Benefits secondary to other
coverage.--The obligation of the Secretary to pay for
any services or benefits 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 provision of law or contractual agreement, to
pay for or provide such services or benefits.</DELETED>
<DELETED> ``(B) No benefits for medicare-eligible
individual.--No benefits shall be available to an
individual under this subsection with respect to any
period in which the individual is eligible for benefits
under title XVIII of the Social Security section (42
U.S.C. 1395 et seq.).</DELETED>
<DELETED> ``(e) Compensation for Lost Employment Income.--</DELETED>
<DELETED> ``(1) In general.--Subject to paragraphs (2) and
(3), an eligible individual shall be entitled to payment of
compensation by the Secretary for loss of employment income
incurred as a result of a covered injury, at the rate specified
in paragraph (2).</DELETED>
<DELETED> ``(2) Amount of compensation.--</DELETED>
<DELETED> ``(A) In general.--Compensation under this
subsection shall be at the rate of
66</DELETED>\<DELETED>2/3</DELETED>\ <DELETED>percent
of monthly pay. The Secretary may consider the
provisions of sections 8114 and 8115 of title 5, United
States Code (and any implementing regulations) in
determining the amount of such payment and the
circumstances under which such payments are reasonable
and necessary.</DELETED>
<DELETED> ``(B) Treatment of self-employment
income.--For purposes of this subsection--</DELETED>
<DELETED> ``(i) the term `employment income'
includes income from self-employment;
and</DELETED>
<DELETED> ``(ii) for purposes of computation
of pay and determination of wage-earning
capacity under subparagraph (A), self-
employment income shall be treated as
wages.</DELETED>
<DELETED> ``(3) Limitations.--</DELETED>
<DELETED> ``(A) Benefits secondary to other
coverage.--The obligation of the Secretary to pay
compensation 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.</DELETED>
<DELETED> ``(B) No benefits for death or permanent
and total disability.--No payment shall be made under
this subsection in compensation for loss of employment
income due to the death or permanent and total
disability of an eligible individual.</DELETED>
<DELETED> ``(C) Limit on total benefits.--Total
benefits paid to an individual under this subsection
shall not exceed $50,000.</DELETED>
<DELETED> ``(D) Waiting period.--An eligible
individual is not entitled to compensation under this
subsection for the first 5 work days of
disability.</DELETED>
<DELETED> ``(f) Payment for Death and Permanent, Total Disability.--
</DELETED>
<DELETED> ``(1) Benefit for permanent and total
disability.--Subject to the succeeding provisions of this
subsection, an eligible individual who is determined, in
accordance with the procedures established under subsection
(b), 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)) shall be entitled to have
payment made by the Secretary of an amount determined under
paragraph (3), in the same manner as disability 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 public safety officer.</DELETED>
<DELETED> ``(2) Death benefit.--Subject to the succeeding
provisions of this subsection, in the case of an eligible
individual whose death is determined, in accordance with the
procedures established under subsection (b), to have directly
resulted from a covered injury or injuries a death benefit in
the amount determined under paragraph (3) shall be payable by
the Secretary 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
public safety officer.</DELETED>
<DELETED> ``(3) Benefit amount.--The amount of the
disability or death benefit under paragraph (1) or (2) in a
fiscal year shall, subject to paragraph (5)(B), 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.</DELETED>
<DELETED> ``(4) Benefit in addition to medical benefits.--A
benefit under this subsection shall be in addition to any
amounts to which an eligible individual may be entitled as
medical benefits under subsection (d).</DELETED>
<DELETED> ``(5) Limitations.--</DELETED>
<DELETED> ``(A) Disability benefits.--No benefit is
payable under paragraph (1) with respect to the
disability of an eligible individual if--</DELETED>
<DELETED> ``(i) a disability benefit is paid
or payable with respect to such individual
under 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</DELETED>
<DELETED> ``(ii) a death benefit is paid or
payable with respect to such individual under
paragraph (2) or 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.).</DELETED>
<DELETED> ``(B) Death benefits.--No benefit is
payable under paragraph (2) with respect to the death
of an eligible individual if--</DELETED>
<DELETED> ``(i) a disability benefit is paid
with respect to such individual under paragraph
(1) or 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</DELETED>
<DELETED> ``(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.).</DELETED>
<DELETED> ``(g) Administration.--</DELETED>
<DELETED> ``(1) Administration by agreement with other
agency or agencies.--The Secretary may administer any or all of
the provisions of this section through Memorandum of Agreement
with the Attorney General or the Secretary of Labor.</DELETED>
<DELETED> ``(2) Regulations.--The head of the agency
administering this section or any provisions thereof (including
any agency head administering such section or provisions
through a Memorandum of Agreement under paragraph (1)) may
promulgate such implementing regulations as may be determined
necessary and appropriate. Initial implementing regulations may
be interim final regulations.</DELETED>
<DELETED> ``(h) Authorization of Appropriations.--There are
authorized to be appropriated such sums as may be necessary for fiscal
year 2003 and each succeeding fiscal year to carry out this section, to
remain available until expended, including administrative costs and
costs of provision and payment of benefits.</DELETED>
<DELETED> ``(i) Relationship to Other Laws.--</DELETED>
<DELETED> ``(1) No preemption of individual rights.--Except
as otherwise provided in this section, nothing in this section
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.</DELETED>
<DELETED> ``(2) Relationship to the federal tort claims
act.--</DELETED>
<DELETED> ``(A) Exhaustion requirement.--An
individual may not seek any remedy that may be
available under section 224(p) (providing a cause of
action under the Federal Tort Claims Act for injuries
resulting from administration of smallpox
countermeasures under such section 224(p)) unless such
individual has first filed a claim for payment or
compensation under this section and has received a
final determination with respect to such
claim.</DELETED>
<DELETED> ``(B) Offset of compensation against
federal tort claims act recovery.--The value of any
compensation or benefits paid to an individual, or the
survivor or survivors of such an individual, or the
estate of the individual pursuant to a claim under this
section shall be offset against any amount to which
such individual or the individual's survivor,
survivors, or estate are entitled under section
224(p).</DELETED>
<DELETED> ``(3) Preemption of state laws providing exclusive
remedy for work-related injuries.--No provision of a State
workers' compensation law or other State law shall be construed
to bar claims or benefits under this section, to the extent
that it purports to make such State law the exclusive remedy
for a work-related injury or otherwise to make benefits under
this section unavailable to an otherwise eligible
individual.''.</DELETED>
<DELETED>TITLE II--PROJECT BIOSHIELD</DELETED>
<DELETED>SEC. 201. SHORT TITLE.</DELETED>
<DELETED> This title may be cited as the ``Project BioShield Act of
2003''.</DELETED>
<DELETED>SEC. 202. BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT
AUTHORITIES.</DELETED>
<DELETED> Part B of title IV of the Public Health Service Act (42
U.S.C. 284 et seq.) is amended by adding at the end the
following:</DELETED>
<DELETED>``SEC. 409I. BIOMEDICAL COUNTERMEASURE RESEARCH AND
DEVELOPMENT.</DELETED>
<DELETED> ``(a) In General.--</DELETED>
<DELETED> ``(1) Authority.--In carrying out research
responsibilities under this Act, the Secretary may conduct and
support research and development with respect to biomedical
countermeasures.</DELETED>
<DELETED> ``(2) Implementation.--</DELETED>
<DELETED> ``(A) In general.--Except as provided in
subparagraph (C), authorities assigned by this section
to the Secretary shall be carried out through the
Director of NIH and the Director of the National
Institute of Allergy and Infectious Diseases.</DELETED>
<DELETED> ``(B) Lead institute.--The National
Institute of Allergy and Infectious Diseases shall be
the lead institute for biomedical countermeasure
research and development under this section.</DELETED>
<DELETED> ``(C) Chemical, radiological, and nuclear
agents.--To the extent that an authority described in
subparagraph (A) is exercised with respect to a
chemical, radiological, or nuclear agent, the Secretary
may authorize the Director of NIH to carry out the
authority through any national research
institute.</DELETED>
<DELETED> ``(3) Interagency cooperation.--</DELETED>
<DELETED> ``(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 Federal
Government and to use other agencies of the Department
of Health and Human Services.</DELETED>
<DELETED> ``(B) Limitation.--An agreement or
undertaking under this paragraph may not authorize
another agency to exercise the authorities provided to
the Secretary by this section.</DELETED>
<DELETED> ``(b) Expedited Procurement Authority.--</DELETED>
<DELETED> ``(1) Increased simplified acquisition threshold
for biomedical countermeasure procurements.--</DELETED>
<DELETED> ``(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 biomedical countermeasure
research or development, 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--
</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(ii) section 302A(b) of such Act
(41 U.S.C. 252a(b)) and its implementing
regulations.</DELETED>
<DELETED> ``(B) Internal controls to be
instituted.--The Secretary shall institute appropriate
internal controls for procurements made under this
paragraph, including requirements with respect to
documenting the justification for use of the authority
provided in this paragraph.</DELETED>
<DELETED> ``(2) Use of noncompetitive procedures.--In
addition to any other authority to use procedures other than
competitive procedures for procurements, the Secretary may use
such other noncompetitive procedures when--</DELETED>
<DELETED> ``(A) the procurement is as described by
paragraph (1)(A); and</DELETED>
<DELETED> ``(B) the property or services needed by
the Secretary 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
meet the needs of the Secretary.</DELETED>
<DELETED> ``(3) Increased micropurchase threshold.--
</DELETED>
<DELETED> ``(A) In general.--For a procurement
described by paragraph (1)(A), 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.</DELETED>
<DELETED> ``(B) Internal controls to be
instituted.--The Secretary shall institute appropriate
internal controls for procurements that are made under
this paragraph and that are greater than
$2,500.</DELETED>
<DELETED> ``(C) Exception to preference for purchase
card mechanism.--No provision of law establishing a
preference for using a Federal Government purchase card
method for purchases shall apply to procurements made
under this paragraph and that are greater than
$2,500.</DELETED>
<DELETED> ``(c) Authority To Expedite Peer Review.--The Secretary
may, as the Secretary determines necessary to respond to pressing
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, determines to be appropriate to obtain an
assessment of scientific and technical merit and likely contribution to
the field of biomedical countermeasure research, in place of the peer
review and advisory council review procedures that would otherwise 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--</DELETED>
<DELETED> ``(1) that is for performing, administering, or
supporting biomedical countermeasure research and development;
and</DELETED>
<DELETED> ``(2) the amount of which is not greater than
$1,500,000.</DELETED>
<DELETED> ``(d) Facilities Authority.--</DELETED>
<DELETED> ``(1) Agency facilities.--In addition to any
similar authority provided under any other provision of law, in
carrying out this section, the Secretary may--</DELETED>
<DELETED> ``(A) acquire, lease, construct, improve,
renovate, remodel, repair, operate, and maintain
laboratories, other research facilities and equipment,
and other real or personal property as the Secretary
determines necessary for the purpose of performing,
administering, and supporting biomedical countermeasure
research and development; and</DELETED>
<DELETED> ``(B) acquire, without regard to section
8141 of title 40, United States Code, by lease or
otherwise, through the Administrator of General
Services, buildings or parts of buildings in the
District of Columbia.</DELETED>
<DELETED> ``(2) Facilities of grantee or cooperative
agreement partner.--</DELETED>
<DELETED> ``(A) In general.--The Secretary may
exercise the authorities described in section 481A with
respect to biocontainment laboratories and other
related or ancillary specialized research facilities as
the Secretary determines necessary for the purpose of
performing, administering, and supporting biomedical
countermeasure research and development.</DELETED>
<DELETED> ``(B) Availability of facility to
secretary.--A grant or cooperative agreement under
subparagraph (A) may provide that the facility that is
the object of such grant or cooperative agreement shall
be available as needed to the Secretary to respond to
public health emergencies affecting national
security.</DELETED>
<DELETED> ``(C) Twenty year use requirement.--A
grant or cooperative agreement under this paragraph
shall include an agreement by the grantee or
cooperative agreement partner that, for not less than
20 years after the completion of the acquisition,
construction, or other work described in subparagraph
(A), the facility will be used for the purposes of the
research and development for which it is to be
acquired, constructed, or otherwise improved.</DELETED>
<DELETED> ``(D) Amount of grant; cost-sharing;
payments.--The provisions of section 481A(e) shall
apply to a grant or cooperative agreement under this
paragraph, except that--</DELETED>
<DELETED> ``(i) authorities exercised under
that section by the Director of the National
Center for Research Resources shall, for
purposes of this paragraph, be exercised by the
Secretary; and</DELETED>
<DELETED> ``(ii) for purposes of this
paragraph, each of the percentages in
subparagraphs (A) and (B) of section 481A(e)(1)
shall be deemed to be 75 percent.</DELETED>
<DELETED> ``(E) Recapture of payments.--If, not
later than 20 years after the completion of
construction for which a grant or cooperative agreement
has been awarded under this paragraph, the facility
shall cease to be used for the research and development
purposes for which it was constructed (unless the
Secretary 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, acquisition, or other improvement of
such facility.</DELETED>
<DELETED> ``(e) Authority for Personal Services Contracts.--
</DELETED>
<DELETED> ``(1) In general.--For the purpose of performing,
administering, and supporting biomedical countermeasure
research and development, the Secretary may, as the Secretary
determines necessary to respond to pressing 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.</DELETED>
<DELETED> ``(2) Federal tort claims act coverage.--
</DELETED>
<DELETED> ``(A) In general.--A person carrying out a
contract under paragraph (1), and an officer, employee,
or governing board member of such person, shall 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.</DELETED>
<DELETED> ``(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 person, officer, employee, or governing
board member.</DELETED>
<DELETED> ``(3) Internal controls to be instituted.--
</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(f) Streamlined Personnel Authority.--</DELETED>
<DELETED> ``(1) In general.--In addition to any other
personnel authorities, the Secretary may, as the Secretary
determines necessary to respond to pressing research and
development needs under this section, without regard to such
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 biomedical countermeasure research and development in
carrying out this section.</DELETED>
<DELETED> ``(2) Internal controls to be instituted.--The
Secretary shall institute appropriate internal controls for
appointments under this subsection.</DELETED>
<DELETED> ``(g) Definition.--As used in this section, the term
`biomedical 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 is used--</DELETED>
<DELETED> ``(1) to treat, identify, or prevent harm from any
biological, chemical, radiological, or nuclear agent that may
cause a public health emergency affecting national security;
or</DELETED>
<DELETED> ``(2) to treat, identify, or prevent 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 paragraph
(1).</DELETED>
<DELETED> ``(h) Actions Committed to Agency Discretion.--Actions by
the Secretary under the authority of this section are committed to
agency discretion.''.</DELETED>
<DELETED> SEC. 203. BIOMEDICAL COUNTERMEASURES PROCUREMENT.</DELETED>
<DELETED> Section 121 of the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (42 U.S.C. 300hh-12) is amended--
</DELETED>
<DELETED> (1) by redesignating subsections (c) through (e)
as subsections (d) through (f), respectively; and</DELETED>
<DELETED> (2) by inserting after subsection (b) the
following:</DELETED>
<DELETED> ``(c) Biomedical Countermeasures Procurement.--</DELETED>
<DELETED> ``(1) Determination of material threats.--
</DELETED>
<DELETED> ``(A) Risk of use.--The Secretary, in
consultation with the heads of other agencies as
appropriate, shall on an ongoing basis--</DELETED>
<DELETED> ``(i) assess current and emerging
threats of use of chemical, biological,
radiological, and nuclear agents; and</DELETED>
<DELETED> ``(ii) determine which of such
agents present a material risk of use against
the United States population.</DELETED>
<DELETED> ``(B) Public health impact.--The Secretary
of Health and Human Services, in consultation with the
Secretary, shall on an ongoing basis--</DELETED>
<DELETED> ``(i) assess the potential public
health consequences of use against the United
States population of agents identified under
subparagraph (A)(ii); and</DELETED>
<DELETED> ``(ii) determine, on the basis of
such assessment, the agents for which
countermeasures are necessary to protect the
public health.</DELETED>
<DELETED> ``(2) Assessment of availability and
appropriateness of countermeasures.--The Secretary of Health
and Human Services, in consultation with the Secretary, shall
assess on an ongoing basis the availability and appropriateness
of specific countermeasures to address specific threats
identified under paragraph (1).</DELETED>
<DELETED> ``(3) Secretary's determination of countermeasures
appropriate for procurement under this subsection.--</DELETED>
<DELETED> ``(A) In general.--The Secretary of Health
and Human Services, in accordance with this paragraph,
shall identify specific countermeasures to threats
identified under paragraph (1) that such Secretary
determines, in consultation with the Secretary of
Homeland Security, to be appropriate for procurement
with appropriations under this subsection for inclusion
in the stockpile under subsection (a).</DELETED>
<DELETED> ``(B) Requirements.--In order for the
Secretary of Health and Human Services to make the
determination under subparagraph (A) with respect to a
countermeasure, the following requirements must be met:</DELETED>
<DELETED> ``(i) Determination of qualified
countermeasure.--Such Secretary must determine
that the product is a qualified countermeasure
(as defined in paragraph (7)).</DELETED>
<DELETED> ``(ii) Determination of quantities
needed and feasibility of production and
distribution.--Such Secretary must determine--
</DELETED>
<DELETED> ``(I) the quantities of
the product that will be needed to meet
the needs of the stockpile;
and</DELETED>
<DELETED> ``(II) that production and
delivery within 5 years of sufficient
quantities of the product, as so
determined, is reasonably expected to
be feasible.</DELETED>
<DELETED> ``(iii) Determination of no
significant commercial market.--Such Secretary
shall--</DELETED>
<DELETED> ``(I) determine that, at
the time of the initial determination
under this paragraph, there is not a
significant commercial market for the
product other than as a homeland
security threat countermeasure;
and</DELETED>
<DELETED> ``(II) annually
redetermine and report to the
President, while a determination under
subparagraph (A) remains in effect with
respect to the product, whether a
significant commercial market exists
for the product other than as a
homeland security threat
countermeasure.</DELETED>
<DELETED> ``(4) Recommendation for president's approval.--
</DELETED>
<DELETED> ``(A) Recommendation for procurement.--In
the case of a countermeasure that the Secretary and the
Secretary of Health and Human Services have determined
is appropriate for procurement under this subsection
for inclusion in the stockpile, in accordance with the
preceding provisions of this subsection, the Secretary
and the Secretary of Health and Human Services shall
jointly submit to the President, in coordination with
the Director of the Office of Management and Budget, a
recommendation for procurement under this
subsection.</DELETED>
<DELETED> ``(B) Presidential approval.--A
countermeasure may be procured under this subsection
only if the President has approved a recommendation
under subparagraph (A) with respect to such
countermeasure.</DELETED>
<DELETED> ``(C) Notice to congress.--The Secretary
shall notify Congress of each decision of the President
to approve a recommendation under subparagraph
(A).</DELETED>
<DELETED> ``(5) Procurement.--The Secretary of Health and
Human Services and the Secretary shall be responsible for the
following, for purposes of procurement of qualified
countermeasures for the stockpile under subsection (a), as
approved by the President under paragraph (4):</DELETED>
<DELETED> ``(A) Interagency agreements.--</DELETED>
<DELETED> ``(i) For procurement.--The
Secretary shall enter into an agreement with
the Secretary of Health and Human Services for
the procurement of the countermeasure in
accordance with the provisions of this
paragraph. Amounts appropriated under paragraph
(8) shall be available for the Secretary of
Health and Human Service's costs of such
procurement, other than as provided in clause
(ii).</DELETED>
<DELETED> ``(ii) For administrative costs.--
The agreement entered into between the
Secretary and the Secretary of Health and Human
Services for managing the stockpile under
subsection (a) shall provide for reimbursement
of the Secretary of Health and Human Service's
administrative costs relating to procurements
under this subsection from appropriations to
carry out such subsection (a).</DELETED>
<DELETED> ``(B) Procurement.--</DELETED>
<DELETED> ``(i) In general.--The Secretary
of Health and Human Services shall be
responsible for--</DELETED>
<DELETED> ``(I) arranging for
procurement of the 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</DELETED>
<DELETED> ``(II) promulgating
regulations to implement clauses (v),
(vi), and (vii), and any other
provisions of this
subsection.</DELETED>
<DELETED> ``(ii) Contract terms.--A contract
for procurements under this subsection shall
(or, as otherwise specified in this clause,
may) include the following terms:</DELETED>
<DELETED> ``(I) Payment conditioned
on substantial delivery.--The contract
shall provide that no payment may be
made until delivery has been made of a
substantial portion (as determined by
the Secretary of Health and Human
Services) of the total number of units
contracted for.</DELETED>
<DELETED> ``(II) Discounted payment
for unlicensed product.--The contract
may provide for a discounted price per
unit of a product that is not licensed
or approved as described in paragraph
(7)(A) at the time of delivery, and may
provide for payment of an additional
amount per unit if the product becomes so licensed 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
or approval).</DELETED>
<DELETED> ``(III) Storage by
vendor.--The contract may provide that
the vendor will provide storage for
stocks of a product delivered to the
ownership of the Government under the
contract, for such period and under
such terms and conditions as the
Secretary of Health and Human Services
may specify, and in such case amounts
appropriated under paragraph (8) shall
be available for costs of shipping,
handling, storage, and related costs
for such product.</DELETED>
<DELETED> ``(IV) Contract
duration.--The contract shall be for a
period not to exceed 5 years, renewable
for additional periods none of which
shall exceed 5 years.</DELETED>
<DELETED> ``(V) Termination for
nondelivery.--In addition to any other
rights of the Secretary of Health and
Human Services to terminate the
contract, the contract may provide that
such Secretary may terminate the
contract for failure to deliver a
reasonable number (as determined by
such Secretary) of units of the product
by 3 years after the date the contract
is entered into, and may further
provide that in such case the vendor
shall not be entitled to any payment
under the contract.</DELETED>
<DELETED> ``(iii) Availability of simplified
acquisition procedures.--The amount of any
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--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(II) section 302A(b) of
such Act (41 U.S.C. 252a(b)) and its
implementing regulations.</DELETED>
<DELETED> ``(iv) Use of noncompetitive
procedures.--In addition to any other authority
to use procedures other than competitive
procedures, the Secretary of Health and Human
Services may use such other procedures for a
procurement under this subsection if the
product is available from only one responsible
source or only from a limited number of
responsible sources, and no other type of
product will satisfy such Secretary's
needs.</DELETED>
<DELETED> ``(v) Premium provision in
multiple award contracts.--</DELETED>
<DELETED> ``(I) In general.--If,
under this subsection, the Secretary of
Health and Human Services enters into
contracts with more than one person to
procure a countermeasure, such
Secretary may, notwithstanding any
other provision of law, include in each
of such contracts a provision that--
</DELETED>
<DELETED> ``(aa) identifies
an increment of the total
quantity of countermeasure
required, whether by percentage
or by numbers of units;
and</DELETED>
<DELETED> ``(bb) promises to
pay one or more specified
premiums based on the priority
of such persons' production and
delivery of the increment
identified under item (aa), in
accordance with the terms and
conditions of the
contract.</DELETED>
<DELETED> ``(II) Determination of
government's requirement not
reviewable.--If the Secretary of Health
and Human Services includes in each of
a set of contracts a provision as
described in clause (I), such
Secretary's determination of the total
quantity of countermeasure required,
and any amendment of such
determination, is committed to agency
discretion.</DELETED>
<DELETED> ``(vi) Extension of closing date
for receipt of proposals not reviewable.--A
decision by the Secretary of Health and Human
Services to extend the closing date for receipt
of proposals for a procurement under this
subsection is committed to agency
discretion.</DELETED>
<DELETED> ``(vii) Limiting competition to
sources responding to request for
information.--In conducting a procurement under
this subsection, the Secretary of Health and
Human Services 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 such Secretary may so
exclude such a source.</DELETED>
<DELETED> ``(6) Interagency cooperation.--</DELETED>
<DELETED> ``(A) In general.--In carrying out
activities under this section, the Secretary and the
Secretary of Health and Human Services are authorized,
subject to subparagraph (B), to enter into interagency agreements and
other collaborative undertakings with other agencies of the United
States Government.</DELETED>
<DELETED> ``(B) Limitation.--An agreement or
undertaking under this paragraph shall not authorize
another agency to exercise the authorities provided by
this section to the Secretary or to the Secretary of
Health and Human Services.</DELETED>
<DELETED> ``(7) Definitions.--In this subsection:</DELETED>
<DELETED> ``(A) Qualified countermeasure.--The term
`qualified countermeasure' means a biomedical
countermeasure--</DELETED>
<DELETED> ``(i) that is approved under
section 505(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) or licensed under
section 351 of the Public Health Service Act
(42 U.S.C. 262) for use as such a
countermeasure to a chemical, biological,
radiological, or nuclear agent identified as a
material threat under paragraph (1);
or</DELETED>
<DELETED> ``(ii) for which the Secretary of
Health and Human Services determines that
sufficient and satisfactory clinical experience
or research data (including data, if available,
from preclinical and clinical trials) support a
reasonable conclusion that the product will
qualify for approval or licensing as such a
countermeasure within 5 years after the date of
a determination under paragraph (3).</DELETED>
<DELETED> ``(B) Biomedical countermeasure.--The term
`biomedical 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))) or
biological product (as that term is defined by section
351(i) of the Public Health Service Act (42 U.S.C.
262(i))) that is used--</DELETED>
<DELETED> ``(i) to treat, identify, or
prevent harm from any biological, chemical,
radiological, or nuclear agent that may cause a
public health emergency affecting national
security; or</DELETED>
<DELETED> ``(ii) to treat, identify, or
prevent harm from a condition that may result
in adverse health consequences or death and may
be caused by administering a drug or biological
product that is used as described in clause
(i).</DELETED>
<DELETED> ``(8) Appropriations.--</DELETED>
<DELETED> ``(A) In general.-- There are
appropriated, out of any moneys in the Treasury not
otherwise appropriated, for fiscal year 2003 and for
each fiscal year thereafter, such sums as may be
necessary for the costs incurred by the Secretary in
the procurement of countermeasures under this
subsection as approved by the President under paragraph
(4) (other than costs specified in subparagraph
(B)).</DELETED>
<DELETED> ``(B) Restrictions.--Amounts appropriated
under this paragraph shall not be available to pay--
</DELETED>
<DELETED> ``(i) costs for the purchase of
vaccines under procurement contracts entered
into before January 1, 2003;</DELETED>
<DELETED> ``(ii) costs under new contracts,
or costs of new obligations under contracts
previously entered into, for procurement of a
countermeasure after the date of a
determination under paragraph (3)(B)(iii) that
there is a significant commercial market for
the countermeasure other than as a homeland
security threat countermeasure; or</DELETED>
<DELETED> ``(iii) administrative
costs.''.</DELETED>
<DELETED> SEC. 204. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN
EMERGENCIES.</DELETED>
<DELETED> (a) In General.--Subchapter E of Chapter V of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb, et seq.) is amended by
adding at the end the following:</DELETED>
<DELETED>``SEC. 564. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN
EMERGENCIES.</DELETED>
<DELETED> ``(a) In General.--Notwithstanding sections 505 and 515 of
this Act and section 351 of the Public Health Service Act, and subject
to the provisions of this section, the Secretary may authorize the
introduction into interstate commerce, during the effective period of a
declaration under subsection (b), of a drug or device intended solely
for use in an actual or potential emergency.</DELETED>
<DELETED> ``(b) Declaration of Emergency.--</DELETED>
<DELETED> ``(1) In general.--The Secretary may declare an
emergency justifying the authorization of a drug or device
under this subsection on the basis of a determination--
</DELETED>
<DELETED> ``(A) by the Secretary of Homeland
Security, that there is a national emergency (or a
significant potential of a national emergency)
involving a heightened risk of attack with a specified
biological, chemical, radiological, or nuclear agent or
agents;</DELETED>
<DELETED> ``(B) by the Secretary of Defense, that
there is a military emergency (or a significant
potential of a military emergency) involving a
heightened risk to United States military forces of
attack with a biological, chemical, radiological, or
nuclear agent or agents; or</DELETED>
<DELETED> ``(C) by the Secretary of a public health
emergency under section 319 of the Public Health
Service Act, involving a specified disease or condition
or a specified biological, chemical, radiological, or
nuclear agent or agents.</DELETED>
<DELETED> ``(2) Termination of declaration.--</DELETED>
<DELETED> ``(A) In general.--A declaration under
this subsection shall terminate upon the earlier of--
</DELETED>
<DELETED> ``(i) a determination by the
Secretary, in consultation as appropriate with
the Secretary of Homeland Security or the
Secretary of Defense, that the circumstances
described in paragraph (1) have ceased to
exist; or</DELETED>
<DELETED> ``(ii) the expiration of the 1-
year period beginning on the date on which the
declaration is made.</DELETED>
<DELETED> ``(B) Renewal.--Notwithstanding
subparagraph (A), the Secretary may renew a declaration
under this subsection, and this paragraph shall apply
to any such renewal.</DELETED>
<DELETED> ``(3) Publication.--The Secretary shall promptly
publish in the Federal Register each declaration,
determination, and renewal under this subsection.</DELETED>
<DELETED> ``(c) Criteria for Issuance of Authorization.--The
Secretary may issue an authorization under this section with respect to
a product if the Secretary concludes--</DELETED>
<DELETED> ``(1) that an agent specified in a declaration
under subsection (b) can cause a serious or life-threatening
disease or condition;</DELETED>
<DELETED> ``(2) that, based on the totality of scientific
evidence available to the Secretary, including data from
adequate and well-controlled clinical trials, if available, it
is reasonable to believe that--</DELETED>
<DELETED> ``(A) the product may be effective in
detecting, diagnosing, treating, or preventing--
</DELETED>
<DELETED> ``(i) such disease or condition;
or</DELETED>
<DELETED> ``(ii) a serious or life-
threatening disease or condition caused by a
product authorized under this section or
approved under this Act or the Public Health
Service Act, for detecting, diagnosing,
treating, or preventing such a disease or
condition caused by such an agent;
and</DELETED>
<DELETED> ``(B) the known and potential benefits of
the product, when used to detect, diagnose, prevent, or
treat such disease or condition, outweigh the known and
potential risks of the product;</DELETED>
<DELETED> ``(3) that there is no adequate, approved, and
available alternative to the product for detecting, diagnosing,
preventing, or treating such disease or condition;
and</DELETED>
<DELETED> ``(4) that such other criteria as the Secretary
may by regulation prescribe are satisfied.</DELETED>
<DELETED> ``(d) Scope of Authorization.--An authorization of a
product under this section shall state--</DELETED>
<DELETED> ``(1) each disease or condition that the product
may be used to detect, diagnose, prevent, or treat within the
scope of the authorization; and</DELETED>
<DELETED> ``(2) the Secretary's conclusions, under
subsection (c), concerning the safety and potential
effectiveness of the product in detecting, diagnosing,
preventing, or treating such diseases or conditions, including
an assessment of the available scientific evidence.</DELETED>
<DELETED> ``(e) Conditions of Authorization.--</DELETED>
<DELETED> ``(1) In general.--The Secretary is authorized, by
order or regulation, to impose such conditions on an
authorization under this section as the Secretary determines
are necessary or appropriate to protect the public health,
including the following:</DELETED>
<DELETED> ``(A) The Secretary shall impose
requirements (including requirements concerning product
labeling and the provision of information) designed to
ensure that, to the maximum extent feasible given the
circumstances of the emergency, health care
professionals administering the product are informed--
</DELETED>
<DELETED> ``(i) that the Secretary has
authorized the product solely for emergency
use;</DELETED>
<DELETED> ``(ii) of the significant known
and potential benefits and risks of use of the
product, and of the extent to which such
benefits and risks are unknown; and</DELETED>
<DELETED> ``(iii) of the alternatives to the
product that are available, and of their
benefits and risks.</DELETED>
<DELETED> ``(B) The Secretary shall impose
requirements (including requirements concerning product
labeling and the provision of information) designed to
ensure that, to the maximum extent feasible given the
circumstances of the emergency, individuals to whom the
product is administered are informed--</DELETED>
<DELETED> ``(i) that the Secretary has
authorized the product solely for emergency
use;</DELETED>
<DELETED> ``(ii) of the significant known
and potential benefits and risks of use of the
product, and of the extent to which such
benefits and risks are unknown; and</DELETED>
<DELETED> ``(iii) of any option to accept or
refuse administration of the product, and of
the alternatives to the product that are
available and of their benefits and
risks.</DELETED>
<DELETED> ``(C) The Secretary may impose limitations
on which entities may distribute the product (including
limitation to distribution by government entities), and
on how distribution is to be performed.</DELETED>
<DELETED> ``(D) The Secretary may impose limitations
on who may administer the product, and on the
categories of individuals to whom, and the
circumstances under which, the product may be
administered.</DELETED>
<DELETED> ``(E) The Secretary may condition the
authorization on the performance of studies, clinical
trials, or other research needed to support marketing
approval of the product.</DELETED>
<DELETED> ``(F) The Secretary may impose
requirements concerning recordkeeping and reporting,
including records access by the Secretary and
publication of data.</DELETED>
<DELETED> ``(G) The Secretary may impose (or waive)
requirements, with respect to the product, of current
good manufacturing practice otherwise applicable to the
manufacture, processing, packing, or holding of
products subject to regulation under this
Act.</DELETED>
<DELETED> ``(H) The Secretary may impose
requirements for the monitoring and reporting of
adverse events associated with use of the
product.</DELETED>
<DELETED> ``(2) Waiver.--The Secretary may waive any
condition imposed under this subsection.</DELETED>
<DELETED> ``(f) Duration of Authorization.--</DELETED>
<DELETED> ``(1) In general.--Except as provided in paragraph
(2), an authorization under this section shall be effective
until the earlier of the termination of the declaration under
subsection (b) or a revocation under subsection (g).</DELETED>
<DELETED> ``(2) Continued use after end of effective
period.--An authorization shall continue to be effective for
continued use with respect to patients to whom it was
administered during the period described by paragraph (1), to
the extent found necessary by such patients' attending
physicians.</DELETED>
<DELETED> ``(g) Revocation of Authorization.--</DELETED>
<DELETED> ``(1) Review.--The Secretary shall periodically
review the circumstances and the appropriateness of an
authorization under this section.</DELETED>
<DELETED> ``(2) Revocation.--The Secretary may revoke an
authorization under this section if, in the Secretary's
unreviewable discretion--</DELETED>
<DELETED> ``(A) the conditions for such an
authorization are no longer met; or</DELETED>
<DELETED> ``(B) other circumstances make such
revocation appropriate.</DELETED>
<DELETED> ``(h) Publication.--The Secretary shall promptly publish
in the Federal Register a notice of each authorization, and each
termination or revocation of an authorization, under this
section.</DELETED>
<DELETED> ``(i) Recordkeeping.--</DELETED>
<DELETED> ``(1) In general.--The Secretary may by order or
regulation require persons, including a person who holds an
authorization under this section, or who manufactures,
distributes, prescribes, or administers a product that is the
subject of such an authorization, to establish and maintain--
</DELETED>
<DELETED> ``(A) data that is obtained from such
activity and that pertains to the effectiveness or
safety of such product;</DELETED>
<DELETED> ``(B) such records as are necessary to
determine, or facilitate a determination, whether there
may be any violation of this section or of a regulation
promulgated under this section; and</DELETED>
<DELETED> ``(C) such additional records as the
Secretary may determine necessary.</DELETED>
<DELETED> ``(2) Access to records by secretary.--</DELETED>
<DELETED> ``(A) Safety and effectiveness
information.--The Secretary may by order or regulation
require a person who holds an authorization under this
section, or who manufactures, distributes, prescribes,
or administers a product that is the subject of such an
authorization to provide to the Secretary all data that
is obtained from such activity and that pertains to the
safety or effectiveness of such product.</DELETED>
<DELETED> ``(B) Other information.--Every person
required under this section to establish or maintain
records, and every person in charge or custody of such
records, shall, upon request by the Secretary, permit
the Secretary at all reasonable times to have access
to, to copy, and to verify such records.</DELETED>
<DELETED> ``(j) Civil Monetary Penalties.--</DELETED>
<DELETED> ``(1) In general.--A person who violates a
requirement of this section or of a regulation or order
promulgated pursuant to this section shall be subject to a
civil money penalty of not more than $100,000 in the case of an
individual, and not more than $250,000 in the case of any other
person, for each violation, not to exceed $1,000,000 for all
such violations adjudicated in a single proceeding.</DELETED>
<DELETED> ``(2) Assessment of civil penalties.--Paragraphs
(3), (4), and (5) of section 303(g) shall apply to a civil
penalty under this subsection, and references in such
paragraphs to `paragraph (1) or (2)' shall, for purposes of
this subsection, be deemed to refer to paragraph (1) of this
subsection.</DELETED>
<DELETED> ``(k) Actions Committed to Agency Discretion.--Actions
under the authority of this section by the Secretary, by the Secretary
of Defense, or by the Secretary of Homeland Security are committed to
agency discretion.</DELETED>
<DELETED> ``(l) Regulations.--The Secretary may promulgate
regulations to implement this section.</DELETED>
<DELETED> ``(m) Construction.--Nothing in this section shall be
construed to impair or otherwise affect--</DELETED>
<DELETED> ``(1) the authority of the President as Commander
in Chief of the Armed Forces of the United States under article
II, section 2 of the United States Constitution; or</DELETED>
<DELETED> ``(2) the authority of the Secretary of Defense
with respect to the Department of Defense, including the armed
forces, under other provisions of Federal law.</DELETED>
<DELETED> ``(n) Application to Members of Armed Forces.--</DELETED>
<DELETED> ``(1) Waiver of requirement relating to option to
refuse.--In the case of the administration of a countermeasure
to members of the armed forces, a requirement, under subsection
(e)(2)(C), designed to ensure that individuals are informed of
an option to accept or refuse administration of a product, may
be waived by the President if the President determines, in
writing, that complying with such requirement is not feasible,
is contrary to the best interests of the members affected, or
is not in the interests of national security.</DELETED>
<DELETED> ``(2) Effect on statute pertaining to
investigational new drugs.--In the case of an authorization
based on a determination by the Secretary of Defense under
subsection (b)(1)(B), section 1107 of title 10, United States
Code, shall not apply to use of a product that is the subject
of such authorization, within the scope of such authorization
and while such authorization is effective.</DELETED>
<DELETED> ``(o) Relation to Other Provisions.--If a product is the
subject of an authorization under this section, the use of such product
within the scope of the authorization--</DELETED>
<DELETED> ``(1) shall not be subject to any requirements
pursuant to section 505(i) or 520(g); and</DELETED>
<DELETED> ``(2) shall not be subject to any requirements
otherwise applicable to clinical investigations pursuant to
other provisions of this Act.''.</DELETED>
<DELETED> (b) Prohibited Acts.--Section 301 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331) is amended--</DELETED>
<DELETED> (1) in subsection (e)--</DELETED>
<DELETED> (A) by striking ``504, 703'' and inserting
``504, 564, 703''; and</DELETED>
<DELETED> (B) by striking ``or 519'' and inserting
``519, or 564''; and</DELETED>
<DELETED> (2) by adding at the end the following:</DELETED>
<DELETED> ``(hh)(1) Promotion or use of a product that is the
subject of an authorization under section 564 other than as stated in
the authorization, or other than during the period described by section
564(g), unless such promotion or use is permitted under another
provision of this Act.</DELETED>
<DELETED> ``(2) Failure to comply with an information requirement
under section 564(e)(1).''.</DELETED>
<DELETED>SEC. 205. DEVELOPING NEW COUNTERMEASURES AND PROTECTING
EXISTING COUNTERMEASURES AGAINST BIOTERRORISM.</DELETED>
<DELETED> Section 319F of the Public Health Service Act (42 U.S.C.
247d-6) is amended by adding at the end the following:</DELETED>
<DELETED> ``(k) Limited Antitrust Exemption.--</DELETED>
<DELETED> ``(1) Countermeasures development meetings.--
</DELETED>
<DELETED> ``(A) Countermeasures development meetings
and consultations.--The Secretary may conduct meetings
and consultations with parties involved in the
development of countermeasures for the purpose of the
development, manufacture, distribution, or sale of
priority countermeasures consistent with the purposes
of this title. The Secretary shall give notice of such
meetings and consultations to the Attorney General and
the Chairperson of the Federal Trade Commission
(referred to in this subsection as the
`Chairperson').</DELETED>
<DELETED> ``(B) Meeting and consultation
conditions.--A meeting or consultation conducted under
subparagraph (A) shall--</DELETED>
<DELETED> ``(i) be chaired or, in the case
of a consultation, facilitated by the Secretary
or the designee of the Secretary;</DELETED>
<DELETED> ``(ii) be open to parties involved
in the development, manufacture, distribution,
purchase, or sale of priority countermeasures,
as determined by the Secretary;</DELETED>
<DELETED> ``(iii) be open to the Attorney
General and the Chairperson;</DELETED>
<DELETED> ``(iv) be limited to discussions
involving the development, manufacture,
distribution, or sale of priority
countermeasures, consistent with the purposes
of this title; and</DELETED>
<DELETED> ``(v) be conducted in such manner
as to ensure that national security,
confidential, and proprietary information is
not disclosed outside the meeting or
consultation.</DELETED>
<DELETED> ``(C) Minutes.--The Secretary shall
maintain minutes of meetings and consultations under
this subsection, which shall not be disclosed under
section 552 of title 5, United States Code.</DELETED>
<DELETED> ``(D) Exemption.--The antitrust laws shall
not apply to meetings and consultations under this
paragraph, except that any agreement that results from
a meeting or consultation and that has been denied an
exemption pursuant to this subsection shall be subject
to the antitrust laws.</DELETED>
<DELETED> ``(2) Written agreements or conduct.--The
Secretary or any party to an agreement or other conduct
regarding covered activities entered into or undertaken
pursuant to meetings or consultations conducted under paragraph
(1), and that is consistent with this paragraph, shall file
such written agreement or a description of the conduct involved
with the Attorney General and the Chairperson for a
determination of whether such agreement or conduct should be
exempt from the antitrust laws. In addition to the proposed
agreement or description of conduct itself, any such filing
shall include--</DELETED>
<DELETED> ``(A) an explanation of the intended
purpose of the agreement or conduct;</DELETED>
<DELETED> ``(B) a specific statement of the
substance of the agreement or conduct;</DELETED>
<DELETED> ``(C) a description of the methods that
will be utilized to achieve the objectives of the
agreement or conduct;</DELETED>
<DELETED> ``(D) an explanation of the necessity of a
cooperative effort among the particular participating
parties to achieve the objectives of the agreement or
conduct; and</DELETED>
<DELETED> ``(E) any other relevant information
reasonably requested by the Attorney General, in
consultation with the Chairperson and the
Secretary.</DELETED>
<DELETED> ``(3) Determination.--The Attorney General, in
consultation with the Chairperson, shall determine whether an
agreement or description of conduct submitted under paragraph
(2) should be exempt from the antitrust laws.</DELETED>
<DELETED> ``(4) Limited antitrust exemption.--</DELETED>
<DELETED> ``(A) In general.--The Attorney General,
in consultation with the Chairperson, may, within 30
days of the receipt of a notification pursuant to
paragraph (2), revoke in whole or in part, the scope of
any exemption granted by the Attorney General under a
determination under paragraph (3).</DELETED>
<DELETED> ``(B) Extension.--The Attorney General may
extend the 35-day period referred to in subparagraph
(A) for an additional period of not to exceed 20 days.
Such additional period may be further extended only by
the United States district court, upon an application
by the Attorney General after notice to the Secretary
and the parties involved.</DELETED>
<DELETED> ``(C) Application of laws.--</DELETED>
<DELETED> ``(i) in general.--The antitrust
laws shall not apply to an agreement or conduct
(described in a description of conduct) that is
submitted for review pursuant to paragraph (2)
until such time as the Attorney General
determines, pursuant to subparagraph (D), that such agreement or
conduct should not, in whole or in part, be exempt from the antitrust
laws.</DELETED>
<DELETED> ``(ii) Limited liability.--No
party to an agreement or conduct referred to in
clause (i) shall be liable under the antitrust
laws for any actions reasonably necessary to
carry out the agreement or for conduct taken
after the agreement or description has been
submitted pursuant to paragraph (2) and prior
to any revocation of the exemption by the
Attorney General pursuant to subparagraph
(D).</DELETED>
<DELETED> ``(D) Determination.--In making a
determination under this subparagraph, the Attorney
General, in consultation with the Chairperson and the
Secretary shall consider--</DELETED>
<DELETED> ``(i) whether the agreement or
conduct involved would facilitate the
availability of priority
countermeasures;</DELETED>
<DELETED> ``(ii) whether the exemption from
the antitrust laws would promote the public
interest;</DELETED>
<DELETED> ``(iii) the competitive impact to
areas not directly related to the purposes of
the agreement or conduct; and</DELETED>
<DELETED> ``(iv) any other factors
determined relevant by the Attorney General and
the Chairperson.</DELETED>
<DELETED> ``(5) Limitation on and renewal of exemptions.--An
exemption provided under paragraphs (3) or (4) shall be limited
to covered activities, and shall expire on the date that is 3
years after the date on which the exemption becomes effective
(and at 3 year intervals thereafter, if renewed) unless the
Attorney General in consultation with the Chairperson
determines that the exemption should be renewed (with
modifications, as appropriate) considering the factors
described in paragraph (4).</DELETED>
<DELETED> ``(6) Limitation on parties.--Any exemption from
the antitrust laws provided under this subsection shall not
apply to the use of any information acquired in conducting
exempted activities for any purposes other than those expressly
specified in the antitrust exemption provided for by this
subsection.</DELETED>
<DELETED> ``(7) Guidelines.--The Attorney General and the
Chairperson may develop and issue guidelines to implement this
subsection.</DELETED>
<DELETED> ``(8) Report.--Not later than 1 year after the
date of enactment of this subsection, and annually thereafter,
the Attorney General and the Chairperson shall report to the
Committee on Health, Education, Labor, and Pensions and the
Committee on the Judiciary of the Senate and the Committee on
Energy and Commerce and the Committee on the Judiciary of the
House of Representatives on the use and continuing need for the
exemption from the antitrust laws provided by this
subsection.</DELETED>
<DELETED> ``(9) Sunset.--The authority of any party to apply
for or to obtain a limited antitrust exemption under this
subsection shall expire at the end of the 6-year period that
begins on the date of enactment of this subsection.</DELETED>
<DELETED> ``(l) Definitions.--In this section:</DELETED>
<DELETED> ``(1) Antitrust laws.--The term `antitrust laws'--
</DELETED>
<DELETED> ``(A) has the meaning given such term in
subsection (a) of the first section of the Clayton Act
(15 U.S.C. 12(a)), except that such term includes the
Act of June 19, 1936 (15 U.S.C. 13 et seq.) commonly
known as the Robinson-Patman Act), and section 5 of the
Federal Trade Commission Act (15 U.S.C. 45) to the
extent such section 5 applies to unfair methods of
competition; and</DELETED>
<DELETED> ``(B) includes any State law similar to
the laws referred to in subparagraph (A).</DELETED>
<DELETED> ``(2) Covered activities.--</DELETED>
<DELETED> ``(A) In general.--Except as provided in
subparagraph (B), the term `covered activities' means
any group of activities or conduct, including
attempting to make, making, or performing a contract or
agreement or engaging in other conduct, for the purpose
of--</DELETED>
<DELETED> ``(i) theoretical analysis,
experimentation, or the systematic study of
phenomena or observable facts related to the
development of priority
countermeasures;</DELETED>
<DELETED> ``(ii) the development or testing
of basic engineering techniques related to the
development of priority
countermeasures;</DELETED>
<DELETED> ``(iii) the extension of
investigative findings or theory of a
scientific or technical nature into practical
application for experimental and demonstration
purposes, including the experimental production
and testing of models, prototypes, equipment,
materials, and processes related to the
development of priority
countermeasures;</DELETED>
<DELETED> ``(iv) the production,
distribution, or marketing of a product,
process, or service related to the development
of priority countermeasures;</DELETED>
<DELETED> ``(v) the testing in connection
with the production of a product, process, or
service related to the development of priority
countermeasures;</DELETED>
<DELETED> ``(vi) the collection, exchange,
and analysis of research or production
information related to the development of
priority countermeasures; or</DELETED>
<DELETED> ``(vii) any combination of the
purposes described in clauses (i) through
(vi);</DELETED>
<DELETED>and such term may include the establishment
and operation of facilities for the conduct of covered
activities described in clauses (i) through (vi), the
conduct of such covered activities on a protracted and
proprietary basis, and the processing of applications
for patents and the granting of licenses for the
results of such covered activities.</DELETED>
<DELETED> ``(B) Exception.--The term `covered
activities' shall not include the following activities
involving 2 or more persons:</DELETED>
<DELETED> ``(i) Exchanging information among
competitors relating to costs, sales,
profitability, prices, marketing, or
distribution of any product, process, or
service if such information is not reasonably
necessary to carry out the purposes of covered
activities.</DELETED>
<DELETED> ``(ii) Entering into any agreement
or engaging in any other conduct--</DELETED>
<DELETED> ``(I) to restrict or
require the sale, licensing, or sharing
of inventions, developments, products,
processes, or services not developed
through, produced by, or distributed or
sold through such covered activities;
or</DELETED>
<DELETED> ``(II) to restrict or
require participation by any person who
is a party to such covered activities
in other research and development
activities, that is not reasonably
necessary to prevent the
misappropriation of proprietary
information contributed by any person
who is a party to such covered
activities or of the results of such
covered activities.</DELETED>
<DELETED> ``(iii) Entering into any
agreement or engaging in any other conduct
allocating a market with a competitor that is
not expressly exempted from the antitrust laws
by a determination under subsection
(k)(4).</DELETED>
<DELETED> ``(iv) Exchanging information
among competitors relating to production (other
than production by such covered activities) of
a product, process, or service if such
information is not reasonably necessary to
carry out the purpose of such covered
activities.</DELETED>
<DELETED> ``(v) Except as otherwise provided
in this subsection or subsection (k), entering
into any agreement or engaging in any other
conduct to restrict or require participation by
any person who is a party to such activities,
in any unilateral or joint activity that is not
reasonably necessary to carry out the purpose
of such covered activities.</DELETED>
<DELETED> ``(3) Development.--The term `development'
includes the identification of suitable compounds or biological
materials, the conduct of preclinical and clinical studies, the
preparation of an application for marketing approval, and any
other actions related to preparation of a
countermeasure.</DELETED>
<DELETED> ``(4) Person.--The term `person' has the meaning
given such term in subsection (a) of the first section of the
Clayton Act (15 U.S.C. 12(a)).</DELETED>
<DELETED> ``(5) Priority countermeasure.--The term `priority
countermeasure' means a countermeasure, including a drug,
medical device, biological product, or diagnostic test to
treat, identify, or prevent infection by a biological agent or
toxin on the list developed under section 351A(a)(1) and
prioritized under subsection (a)(1).''.</DELETED>
<DELETED>TITLE III--IMPROVED VACCINE AFFORDABILITY AND
AVAILABILITY</DELETED>
<DELETED>SEC. 301. SHORT TITLE.</DELETED>
<DELETED> This title may be cited as the ``Improved Vaccine
Affordability and Availability Act''.</DELETED>
<DELETED>Subtitle A--State Vaccine Grants</DELETED>
<DELETED>SEC. 311. AVAILABILITY OF INFLUENZA VACCINE.</DELETED>
<DELETED> Section 317(j) of the Public Health Service Act (42 U.S.C.
247b(j)) is amended by adding at the end the following:</DELETED>
<DELETED> ``(3)(A) For the purpose of carrying out activities
relating to influenza vaccine under the immunization program under this
subsection, there are authorized to be appropriated such sums as may be
necessary for each of fiscal years 2003 and 2004. Such authorization
shall be in addition to amounts available under paragraphs (1) and (2)
for such purpose.</DELETED>
<DELETED> ``(B) The authorization of appropriations established in
subparagraph (A) shall not be effective for a fiscal year unless the
total amount appropriated under paragraphs (1) and (2) for the fiscal
year is not less than such total for fiscal year 2000.</DELETED>
<DELETED> ``(C) The purposes for which amounts appropriated under
subparagraph (A) are available to the Secretary include providing for
improved State and local infrastructure for influenza immunizations
under this subsection in accordance with the following:</DELETED>
<DELETED> ``(i) Increasing influenza immunization rates in
populations considered by the Secretary to be at high risk for
influenza-related complications and in their
contacts.</DELETED>
<DELETED> ``(ii) Recommending that health care providers
actively target influenza vaccine that is available in
September, October, and November to individuals who are at
increased risk for influenza-related complications and to their
contacts.</DELETED>
<DELETED> ``(iii) Providing for the continued availability
of influenza immunizations through December of such year, and
for additional periods to the extent that influenza vaccine
remains available.</DELETED>
<DELETED> ``(iv) Encouraging States, as appropriate, to
develop contingency plans (including plans for public and
professional educational activities) for maximizing influenza
immunizations for high-risk populations in the event of a delay
or shortage of influenza vaccine.</DELETED>
<DELETED> ``(D) The Secretary 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, periodic
reports describing the activities of the Secretary under this
subsection regarding influenza vaccine. The first such report shall be
submitted not later than June 6, 2003, the second report shall
be submitted not later than June 6, 2004, and subsequent reports shall
be submitted biennially thereafter.''.</DELETED>
<DELETED>SEC. 312. PROGRAM FOR INCREASING IMMUNIZATION RATES FOR ADULTS
AND ADOLESCENTS; COLLECTION OF ADDITIONAL IMMUNIZATION
DATA.</DELETED>
<DELETED> (a) Activities of Centers for Disease Control and
Prevention.--Section 317(j) of the Public Health Service Act (42 U.S.C.
247b(j)), as amended by section 311, is further amended by adding at
the end the following:</DELETED>
<DELETED> ``(4)(A) For the purpose of carrying out activities to
increase immunization rates for adults and adolescents through the
immunization program under this subsection, and for the purpose of
carrying out subsection (k)(2), there are authorized to be appropriated
$50,000,000 for fiscal year 2003, and such sums as may be necessary for
each of the fiscal years 2004 through 2006. Such authorization is in
addition to amounts available under paragraphs (1), (2), and (3) for
such purposes.</DELETED>
<DELETED> ``(B) In expending amounts appropriated under subparagraph
(A), the Secretary shall give priority to adults and adolescents who
are medically underserved and are at risk for vaccine-preventable
diseases, including as appropriate populations identified through
projects under subsection (k)(2)(E).</DELETED>
<DELETED> ``(C) The purposes for which amounts appropriated under
subparagraph (A) are available include (with respect to immunizations
for adults and adolescents) the payment of the costs of storing
vaccines, outreach activities to inform individuals of the availability
of the immunizations, and other program expenses necessary for the
establishment or operation of immunization programs carried out or
supported by States or other public entities pursuant to this
subsection.</DELETED>
<DELETED> ``(5) The Secretary shall annually submit to Congress a
report that--</DELETED>
<DELETED> ``(A) evaluates the extent to which the
immunization system in the United States has been effective in
providing for adequate immunization rates for adults and
adolescents, taking into account the applicable year 2010
health objectives established by the Secretary regarding the
health status of the people of the United States; and</DELETED>
<DELETED> ``(B) describes any issues identified by the
Secretary that may affect such rates.</DELETED>
<DELETED> ``(6) In carrying out this subsection and paragraphs (1)
and (2) of subsection (k), the Secretary shall consider recommendations
regarding immunizations that are made in reports issued by the
Institute of Medicine of the National Academy of Sciences.''.</DELETED>
<DELETED> (b) Research, Demonstrations, and Education.--Section
317(k) of the Public Health Service Act (42 U.S.C. 247b(k)) is
amended--</DELETED>
<DELETED> (1) by redesignating paragraphs (2) through (4) as
paragraphs (3) through (5), respectively;</DELETED>
<DELETED> (2) by inserting after paragraph (1) the
following:</DELETED>
<DELETED> ``(2)(A) The Secretary, directly and through grants under
paragraph (1), shall provide for a program of research, demonstration
projects, and education in accordance with the following:</DELETED>
<DELETED> ``(i) The Secretary shall coordinate with public
and private entities (including nonprofit private entities),
and develop and disseminate guidelines, toward the goal of
ensuring that immunizations are routinely offered to adults and
adolescents by public and private health care
providers.</DELETED>
<DELETED> ``(ii) The Secretary shall cooperate with public
and private entities to obtain information for the annual
evaluations required in subsection (j)(5)(A).</DELETED>
<DELETED> ``(iii) The Secretary shall (relative to fiscal
year 2003) increase the extent to which the Secretary collects
data on the incidence, prevalence, and circumstances of
diseases and adverse events that are experienced by adults and
adolescents and may be associated with immunizations, including
collecting data in cooperation with commercial
laboratories.</DELETED>
<DELETED> ``(iv) The Secretary shall ensure that the
entities with which the Secretary cooperates for purposes of
subparagraphs (A) through (C) include managed care
organizations, community-based organizations that provide
health services, and other health care providers.</DELETED>
<DELETED> ``(v) The Secretary shall provide for projects to
identify racial and ethnic minority groups and other health
disparity populations for which immunization rates for adults
and adolescents are below such rates for the general
population, and to determine the factors underlying such
disparities.</DELETED>
<DELETED> ``(B) 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 2003 through
2007.''.</DELETED>
<DELETED>SEC. 313. IMMUNIZATION AWARENESS.</DELETED>
<DELETED> (a) Development of Information Concerning Meningitis.--
</DELETED>
<DELETED> (1) In general.--The Secretary of Health and Human
Services (in this title referred to as the ``Secretary''), in
consultation with the Director of the Centers for Disease
Control and Prevention, shall develop and make available to
entities described in paragraph (2) information concerning
bacterial meningitis and the availability and effectiveness of
vaccinations for populations targeted by the Advisory Committee
on Immunization Practices (an advisory committee established by
the Secretary, acting through the Director of the Centers for
Disease Control and Prevention).</DELETED>
<DELETED> (2) Entities.--An entity is described in this
paragraph if the entity--</DELETED>
<DELETED> (A) is--</DELETED>
<DELETED> (i) a college or university;
or</DELETED>
<DELETED> (ii) any other facility with a
setting similar to a dormitory that houses age-
appropriate populations for whom the Advisory
Committee on Immunization Practices recommends
such a vaccination; and</DELETED>
<DELETED> (B) is determined appropriate by the
Secretary.</DELETED>
<DELETED> (b) Development of Information Concerning Hepatitis.--
</DELETED>
<DELETED> (1) In general.--The Secretary, in consultation
with the Director of the Centers for Disease Control and
Prevention, shall develop and make available to entities described in
paragraph (2) information concerning hepatitis A and B and the
availability and effectiveness of vaccinations with respect to such
diseases.</DELETED>
<DELETED> (2) Entities.--An entity is described in this
paragraph if the entity--</DELETED>
<DELETED> (A) is--</DELETED>
<DELETED> (i) a health care clinic that
serves individuals diagnosed as being infected
with HIV or as having other sexually
transmitted diseases;</DELETED>
<DELETED> (ii) an organization or business
that counsels individuals about international
travel or who arranges for such
travel;</DELETED>
<DELETED> (iii) a police, fire, or emergency
medical services organization that responds to
natural or man-made disasters or
emergencies;</DELETED>
<DELETED> (iv) a prison or other detention
facility;</DELETED>
<DELETED> (v) a college or university;
or</DELETED>
<DELETED> (vi) a public health authority or
children's health service provider in areas of
intermediate or high endemicity for hepatitis A
as defined by the Centers for Disease Control
and Prevention; and</DELETED>
<DELETED> (B) is determined appropriate by the
Secretary.</DELETED>
<DELETED>SEC. 314. SUPPLY OF VACCINES.</DELETED>
<DELETED> (a) In General.--The Secretary of Health and Human
Services, acting through the Director of the Centers for Disease
Control and Prevention, shall prioritize, acquire, and maintain a
supply of such prioritized vaccines sufficient to provide vaccinations
throughout a 6-month period.</DELETED>
<DELETED> (b) Proceeds.--Any proceeds received by the Secretary of
Health and Human Services from the sale of vaccines contained in the
supply described in subsection (a), shall be available to the Secretary
for the purpose of purchasing additional vaccines for the supply. Such
proceeds shall remain available until expended.</DELETED>
<DELETED> (c) Authorization of Appropriations.--There are authorized
to be appropriated for the purpose of carrying out subsection (a) such
sums as may be necessary for each of fiscal years 2003 through
2008.</DELETED>
<DELETED>SEC. 315. COMMUNICATION.</DELETED>
<DELETED> The Commissioner of Food and Drugs shall ensure that
vaccine manufacturers receive all forms of compliance guidelines for
vaccines and that such guidelines are kept up to date.</DELETED>
<DELETED>SEC. 316. FAST TRACK.</DELETED>
<DELETED> The Commissioner of Food and Drugs shall issue regulations
to revise the policies of the Food and Drug Administration regarding
fast-tracking and priority review approval of vaccine products
currently under development, to allow for the use of new forms of
existing vaccines in cases where a determination is made that applying
such approvals is in the public health interest to address the unmet
need of strengthening the overall vaccine supply.</DELETED>
<DELETED>SEC. 317. STUDY.</DELETED>
<DELETED> (a) In General.--The Secretary shall contract with the
Institute of Medicine of the National Academy of Sciences or another
independent and competent authority, to conduct a study of the
statutes, regulations, guidelines, and compliance, inspection, and
enforcement practices and policies of the Department of Health and
Human Services and of the Food and Drug Administration that are
applicable to vaccines intended for human use that are in periodic
short supply in the United States.</DELETED>
<DELETED> (b) Requirements.--The study under subsection (a) shall
include a review of the regulatory requirements, guidelines, practices,
and policies--</DELETED>
<DELETED> (1) for the development and licensing of vaccines
and the licensing of vaccine manufacturing
facilities;</DELETED>
<DELETED> (2) for inspections and other activities for
maintaining compliance and enforcement of the requirements
applicable to such vaccines and facilities; and</DELETED>
<DELETED> (3) that may have contributed to temporary or
long-term shortages of vaccines.</DELETED>
<DELETED> (c) Report.--Not later than 6 months after the date of
enactment of this Act, the Secretary shall 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 that
contains--</DELETED>
<DELETED> (1) the results of the study under subsection (a);
and</DELETED>
<DELETED> (2) recommendations for modifications to the
regulatory requirements, guidelines, practices, and policies
described in subsection (b).</DELETED>
<DELETED>Subtitle B--Vaccine Injury Compensation Program</DELETED>
<DELETED>SEC. 321. ADMINISTRATIVE REVISION OF VACCINE INJURY
TABLE.</DELETED>
<DELETED> Section 2114 of the Public Health Service Act (42 U.S.C.
300aa-14) is amended--</DELETED>
<DELETED> (1) by striking subsection (c)(1) and inserting
the following:</DELETED>
<DELETED> ``(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 for at least 60 days of public
comment.''; and</DELETED>
<DELETED> (2) in subsection (d), by striking ``90 days'' and
inserting ``60 days''.</DELETED>
<DELETED>SEC. 322. EQUITABLE RELIEF.</DELETED>
<DELETED> Section 2111(a)(2)(A) of the Public Health Service Act (42
U.S.C. 300aa-11(a)(2)(A)) is amended by striking ``No person'' and all
that follows through ``and--'' and inserting the following: ``No person
may bring or maintain a civil action against a vaccine administrator or
manufacturer in a Federal or State court for damages arising from, or
equitable relief relating to, a vaccine-related injury or death
associated with the administration of a vaccine after October 1, 1988
and no such court may award damages or equitable relief for any such
vaccine-related injury or death, unless the person proves past or
present physical injury and a timely petition has been filed in
accordance with section 2116 for compensation under the Program for
such injury or death and--''.</DELETED>
<DELETED>SEC. 323. DERIVATIVE PETITIONS FOR COMPENSATION.</DELETED>
<DELETED> (a) Limitations on Derivative Petitions.--Section
2111(a)(2) of the Public Health Service Act (42 U.S.C. 300aa-11(a)(2))
is amended--</DELETED>
<DELETED> (1) in subparagraph (B), by inserting ``or (B)''
after ``subparagraph (A)'';</DELETED>
<DELETED> (2) by redesignating subparagraph (B) as
subparagraph (C); and</DELETED>
<DELETED> (3) by inserting after subparagraph (A) the
following:</DELETED>
<DELETED> ``(B)(i) No parent or other third party may bring
or maintain a civil action against a vaccine administrator or
manufacturer in a Federal or State court for damages or
equitable relief relating to a vaccine-related injury or death,
including without limitation damages for loss of consortium,
society, companionship, or services, loss of earnings, medical
or other expenses, and emotional distress, and no court may
award damages or equitable relief in such an action, unless--
</DELETED>
<DELETED> ``(I) the person who sustained the
underlying vaccine-related injury or death upon which
such parent's or other third party's claim is premised
has timely filed a petition for compensation in
accordance with section 2111;</DELETED>
<DELETED> ``(II) such parent or other third party is
the legal representative or spouse of the person who
sustained the underlying vaccine-related injury or
death, and such legal representative or spouse has
filed a timely derivative petition, in accordance with
section 2116; and</DELETED>
<DELETED> ``(III)(aa) the United States Court of
Federal Claims has issued judgment under section 2112
on the derivative petition, and such legal
representative or spouse elects under section 2121(a)
to file a civil action; or</DELETED>
<DELETED> ``(bb) such legal representative or spouse
elects to withdraw such derivative petition under
section 2121(b) or such petition is considered
withdrawn under such section.</DELETED>
<DELETED> ``(ii) Any civil action brought in accordance with
this subparagraph shall be subject to the standards and
procedures set forth in sections 2122 and 2123, regardless of
whether the action arises directly from a vaccine-related
injury or death associated with the administration of a
vaccine. In a case in which the person who sustained the
underlying vaccine-related injury or death upon which such
legal representative's or spouse's civil action is premised
elects under section 2121(a) to receive the compensation
awarded, such legal representative or spouse may not bring a
civil action for damages or equitable relief, and no court may
award damages or equitable relief, for any injury or loss of
the type set forth in section 2115(a) or that might in any way
overlap with or otherwise duplicate compensation of the type
available under section 2115(a).''.</DELETED>
<DELETED> (b) Eligible Persons.--Section 2111(a)(9) of the Public
Health Service Act (42 U.S.C. 300aa-11(a)(9)) is amended by striking
the period and inserting ``and to a parent or other third party to the
extent such parent or other third party seeks damages or equitable
relief relating to a vaccine-related injury or death sustained by a
person who is qualified to file a petition for compensation under the
Program.''.</DELETED>
<DELETED> (c) Petitioners.--Section 2111(b) of the Public Health
Service Act (42 U.S.C. 300aa-11(b)) is amended--</DELETED>
<DELETED> (1) in paragraph (1)--</DELETED>
<DELETED> (A) in subparagraph (A), by striking
``(B)'' and inserting ``(C)'';</DELETED>
<DELETED> (B) by redesignating subparagraph (B) as
subparagraph (C); and</DELETED>
<DELETED> (C) by inserting after subparagraph (A)
the following:</DELETED>
<DELETED> ``(B) Except as provided in subparagraph (C), any
legal representative or spouse of a person--</DELETED>
<DELETED> ``(i) who has sustained a vaccine-related
injury or death; and</DELETED>
<DELETED> ``(ii) who has filed a petition for
compensation under the Program (or whose legal
representative has filed such a petition as authorized
in subparagraph (A));</DELETED>
<DELETED>may, if such legal representative or spouse meets the
requirements of subsection (d), file a derivative petition
under this section.''; and</DELETED>
<DELETED> (2) in paragraph (2)--</DELETED>
<DELETED> (A) by inserting ``by or on behalf of the
person who sustained the vaccine-related injury or
death'' after ``filed''; and</DELETED>
<DELETED> (B) by adding at the end the following:
``A legal representative or spouse may file only 1
derivative petition with respect to each underlying
petition.''.</DELETED>
<DELETED> (d) Derivative Petition Contents.--Section 2111 of the
Public Health Service Act (42 U.S.C. 300aa-11) is amended--</DELETED>
<DELETED> (1) by redesignating subsections (d) and (e) as
subsections (e) and (f), respectively; and</DELETED>
<DELETED> (2) by inserting after subsection (c) the
following:</DELETED>
<DELETED> ``(d) Derivative Petitions.--</DELETED>
<DELETED> ``(1) If the legal representative or spouse of the
person who sustained the vaccine-related injury or death seeks
compensation under the Program, such legal representative or
spouse shall file a timely derivative petition for compensation
under the Program in accordance with this section.</DELETED>
<DELETED> ``(2) Such a derivative petition shall contain--
</DELETED>
<DELETED> ``(A) except for records that are
unavailable as described in subsection (c)(3), an
affidavit, and supporting documentation, demonstrating
that--</DELETED>
<DELETED> ``(i) the child or spouse of such
person has, in accordance with section 2111,
timely filed a petition for compensation for
the underlying vaccine-related injury or death
upon which such legal representative's or
spouse's derivative petition is
premised;</DELETED>
<DELETED> ``(ii) the derivative petition was
timely filed;</DELETED>
<DELETED> ``(iii) such legal representative
or spouse suffered a loss compensable under
section 2115(b) as a result of the vaccine-
related injury or death sustained by such
person; and</DELETED>
<DELETED> ``(iv) such legal representative
or spouse has not previously collected an award
or settlement of a civil action for damages for
such loss; and</DELETED>
<DELETED> ``(B) records establishing such legal
representative's or spouse's relationship to the person
who sustained the vaccine-related injury or
death.''.</DELETED>
<DELETED> (e) Determination of Eligibility for Compensation.--
Section 2113(a)(1) of the Public Health Service Act (42 U.S.C. 300aa-
13(a)(1)) is amended--</DELETED>
<DELETED> (1) in subparagraph (A), by striking ``and'' and
inserting ``or, as applicable, section 2111(d),'';</DELETED>
<DELETED> (2) in subparagraph (B), by striking the period
and inserting ``, and''; and</DELETED>
<DELETED> (3) by inserting before the flush matter at the
end, the following:</DELETED>
<DELETED> ``(C) in the case of a derivative
petition, that the person who sustained the underlying
vaccine-related injury or death upon which the
derivative petition is premised has timely filed a
petition for compensation in accordance with section
2111 and that, with respect to such underlying
petition, the special master or court has made the
findings specified in subparagraphs (A) and (B) of this
paragraph.''.</DELETED>
<DELETED> (f) Compensation.--Section 2115 of the Public Health
Service Act (42 U.S.C. 300aa-15) is amended--</DELETED>
<DELETED> (1) by redesignating subsections (b) through (j)
as subsections (c) through (k), respectively;</DELETED>
<DELETED> (2) by inserting after subsection (a) the
following:</DELETED>
<DELETED> ``(b) Derivative Petitions.--</DELETED>
<DELETED> ``(1) In general.--Compensation awarded under the
Program to a legal representative or spouse who files a
derivative petition under section 2111 for a loss sustained as
a result of a vaccine-related injury or death sustained by such
petitioner's child or spouse shall only include compensation
for any loss of consortium, society, companionship, or
services, in an amount not to exceed the lesser of $250,000 or
the total amount of compensation awarded to the person who
sustained the underlying vaccine-related injury or
death.</DELETED>
<DELETED> ``(2) Multiple individuals.--Where more than 1
person files a derivative petition under section 2111 for
losses sustained as a result of the same underlying vaccine-
related injury or death, the aggregate compensation to such
persons shall not exceed the lesser of $250,000, or the total
amount of compensation awarded to the person who sustained the
underlying vaccine-related injury or death. The special master
or court shall apportion compensation among the derivative
petitioners in proportion to their respective
losses.'';</DELETED>
<DELETED> (3) in subsection (e)(2), as so redesignated by
paragraph (1)--</DELETED>
<DELETED> (A) by striking ``(2) and (3)'' and
inserting ``(2), (3), (4), (5), and (6)'';
and</DELETED>
<DELETED> (B) by inserting ``and subsection (b),''
after ``(a),'';</DELETED>
<DELETED> (4) in subsection (g), as so redesignated by
paragraph (1), in paragraph (4)(B), by striking ``subsection
(j)'' and inserting ``subsection (k)'';</DELETED>
<DELETED> (5) in subsection (j), as so redesignated by
paragraph (1)--</DELETED>
<DELETED> (A) in paragraph (1), by striking
``subsection (j)'' and inserting ``subsection (k)'';
and</DELETED>
<DELETED> (B) in paragraph (2), by inserting ``, or
to a legal representative or spouse of a person who
sustained a vaccine-related injury or death,'' after
``death''; and</DELETED>
<DELETED> (6) in subsection (k), as so redesignated by
paragraph (1), by striking ``subsection (f)(4)(B)'' and
inserting ``subsection (g)(4)(B)''.</DELETED>
<DELETED>SEC. 324. JURISDICTION TO DISMISS ACTIONS IMPROPERLY
BROUGHT.</DELETED>
<DELETED> Section 2111(a)(3) of the Public Health Service Act (42
U.S.C. 300aa-11(a)(3)) is amended by adding at the end the following:
``If any civil action which is barred under subparagraph (A) or (B) of
paragraph (2) is filed or maintained in a State court, or any vaccine
administrator or manufacturer is made a party to any civil action
brought in State court (other than a civil action which may be brought
under paragraph (2)) for damages or equitable relief for a vaccine-
related injury or death associated with the administration of a vaccine
after October 1, 1988, the civil action may be removed at any time
before final judgment by the defendant or defendants to the United
States Court of Federal Claims. Once removed, the United States Court
of Federal Claims shall have jurisdiction solely for the purpose of
adjudicating whether the civil action should be dismissed pursuant to
this section. If the United States Court of Federal Claims determines
that the civil action should not be dismissed, the court shall remand
the action to the State Court. The notice required by section 1446 of
title 28, United States Code, shall be filed with the United States
Court of Federal Claims, and that court shall, except as otherwise
provided in this section, proceed in accordance with sections 1446
through 1451 of title 28, United States Code.''.</DELETED>
<DELETED>SEC. 325. CLARIFICATION OF WHEN INJURY IS CAUSED BY FACTOR
UNRELATED TO ADMINISTRATION OF VACCINE.</DELETED>
<DELETED> Section 2113(a)(2)(B) of the Public Health Service Act (42
U.S.C. 300aa-13(a)(2)(B)) is amended--</DELETED>
<DELETED> (1) by inserting ``structural lesions, genetic
disorders,'' after ``and related anoxia),'';</DELETED>
<DELETED> (2) by inserting ``(without regard to whether the
cause of the infection, toxin, trauma, structural lesion,
genetic disorder, or metabolic disturbance is known)'' after
``metabolic disturbances''; and</DELETED>
<DELETED> (3) by striking ``but'' and inserting
``and''.</DELETED>
<DELETED>SEC. 326. INCREASE IN AWARD IN THE CASE OF A VACCINE-RELATED
DEATH AND FOR PAIN AND SUFFERING.</DELETED>
<DELETED> (a) In General.--Section 2115(a) of the Public Health
Service Act (42 U.S.C. 300aa-15(a)) is amended--</DELETED>
<DELETED> (1) in paragraph (2), by striking ``$250,000'' and
inserting ``$350,000''; and</DELETED>
<DELETED> (2) in paragraph (4), by striking ``$250,000'' and
inserting ``$350,000''.</DELETED>
<DELETED> (b) Death Awards.--Section 2115(a)(2) of the Public Health
Service Act (42 U.S.C. 300aa-15(a)(2)) is amended by inserting ``(if
the deceased incurred unreimbursable expenses due to the vaccine-
related injury prior to death in excess of $50,000, the award shall
also include reimbursement for those unreimbursable expenses that
exceed $50,000)'' before the period.</DELETED>
<DELETED>SEC. 327. BASIS FOR CALCULATING PROJECTED LOST
EARNINGS.</DELETED>
<DELETED> Section 2115(a)(3)(B) of the Public Health Service Act (42
U.S.C. 300aa-15(a)(3)(B)) is amended by striking ``loss of earnings''
and all that follows and inserting the following: ``loss of earnings
determined on the basis of the annual estimate of the average (mean)
gross weekly earnings of wage and salary workers age 18 and over
(excluding the incorporated self-employed) in the private non-farm
sector (which includes all industries other than agricultural
production crops and livestock), as calculated annually by the Bureau
of Labor Statistics from the quarter sample data of the Current
Population Survey, or as calculated by such similar method as the
Secretary may prescribe by regulation, less appropriate taxes and the
average cost of a health insurance policy, as determined by the
Secretary.''.</DELETED>
<DELETED>SEC. 328. ALLOWING COMPENSATION FOR FAMILY COUNSELING EXPENSES
AND EXPENSES OF ESTABLISHING AND MAINTAINING
GUARDIANSHIP.</DELETED>
<DELETED> (a) Family Counseling Expenses in Post-1988 Cases.--
Section 2115(a) of the Public Health Service Act (42 U.S.C. 300aa-
15(a)) is amended by adding at the end the following:</DELETED>
<DELETED> ``(5) Actual unreimbursable expenses that have
been or will be incurred for family counseling as is determined
to be reasonably necessary and that result from the vaccine-
related injury from which the petitioner seeks
compensation.''.</DELETED>
<DELETED> (b) Expenses of Establishing and Maintaining Guardianships
in Post-1988 Cases.--Section 2115(a) of the Public Health Service Act
(42 U.S.C. 300aa-15(a)), as amended by subsection (a), is further
amended by adding at the end the following:</DELETED>
<DELETED> ``(6) Actual unreimbursable expenses that have
been, or will be reasonably incurred to establish and maintain
a guardianship or conservatorship for an individual who has
suffered a vaccine-related injury, including attorney fees and
other costs incurred in a proceeding to establish and maintain
such guardianship or conservatorship.''.</DELETED>
<DELETED> (c) Conforming Amendment for Cases From 1988 and
Earlier.--Section 2115 of the Public Health Service Act (42 U.S.C.
300aa-15) is amended in subsection (c), as so redesignated by section
323(f)--</DELETED>
<DELETED> (1) in paragraph (2), by striking ``and'' at the
end;</DELETED>
<DELETED> (2) in paragraph (3), by striking ``(e)'' and
inserting ``(f)'';</DELETED>
<DELETED> (3) by redesignating paragraph (3) as paragraph
(5); and</DELETED>
<DELETED> (4) by inserting after paragraph (2), the
following:</DELETED>
<DELETED> ``(3) family counseling expenses (as provided for
in paragraph (5) of subsection (a));</DELETED>
<DELETED> ``(4) expenses of establishing and maintaining
guardianships (as provided for in paragraph (6) of subsection
(a)); and''.</DELETED>
<DELETED>SEC. 329. ALLOWING PAYMENT OF INTERIM COSTS.</DELETED>
<DELETED> Section 2115 of the Public Health Service Act (42 U.S.C.
300aa-15) is amended in subsection (f), as so redesignated by section
323(f), by adding at the end the following:</DELETED>
<DELETED> ``(4) A special master or court may make an
interim award of costs subject to final adjustment if--
</DELETED>
<DELETED> ``(A) the case involves a vaccine
administered on or after October 1, 1988;</DELETED>
<DELETED> ``(B) the special master or court has
determined that the petitioner is entitled to
compensation under the Program;</DELETED>
<DELETED> ``(C) the award is limited to other costs
(within the meaning of paragraph (1)(B)) incurred in
the proceeding;</DELETED>
<DELETED> ``(D) not more than 1 prior award has been
made with respect to such petition; and</DELETED>
<DELETED> ``(E) the petitioner provides
documentation verifying the expenditure of the amount
for which compensation is sought.''.</DELETED>
<DELETED>SEC. 330. PROCEDURE FOR PAYING ATTORNEYS' FEES.</DELETED>
<DELETED> Section 2115 of the Public Health Service Act (42 U.S.C.
300aa-15), is amended in subsection (f), as so redesignated by section
323(f) and amended by section 329, by adding at the end the
following:</DELETED>
<DELETED> ``(5) When a special master or court awards
attorney fees or costs under paragraph (1) or (4), it may order
that such fees or costs be payable solely to the petitioner's
attorney if--</DELETED>
<DELETED> ``(A) the petitioner expressly consents;
or</DELETED>
<DELETED> ``(B) the special master or court
determines, after affording to the Secretary and to all
interested persons the opportunity to submit relevant
information, that--</DELETED>
<DELETED> ``(i) the petitioner cannot be
located or refuses to respond to a request by
the special master or court for information,
and there is no practical alternative means to
ensure that the attorney will be reimbursed for
such fees or costs expeditiously; or</DELETED>
<DELETED> ``(ii) there are otherwise
exceptional circumstances and good cause for
paying such fees or costs solely to the
petitioner's attorney.''.</DELETED>
<DELETED>SEC. 331. EXTENSION OF STATUTE OF LIMITATIONS.</DELETED>
<DELETED> (a) General Rule.--Section 2116(a) of the Public Health
Service Act (42 U.S.C. 300aa-16(a)) is amended--</DELETED>
<DELETED> (1) in paragraph (2), by striking ``36 months''
and inserting ``6 years''; and</DELETED>
<DELETED> (2) in paragraph (3), by striking ``48 months''
and inserting ``6 years''.</DELETED>
<DELETED> (b) Claims Based on Revisions to Table.--Section 2116 of
the Public Health Service Act (42 U.S.C. 300aa-16) is amended by
striking subsection (b) and inserting the following:</DELETED>
<DELETED> ``(b) Effect of Revised Table.--If at any time the Vaccine
Injury Table is revised and the effect of such revision is to make an
individual eligible for compensation under the program, where, before
such revision, such individual was not eligible for compensation under
the program, or to significantly increase the likelihood that an
individual will be able to obtain compensation under the program, such
person may, and shall before filing a civil action for equitable relief
or monetary damages, notwithstanding section 2111(b)(2), file a
petition for such compensation if--</DELETED>
<DELETED> ``(1) the vaccine-related death or injury with
respect to which the petition is filed occurred not more than
10 years before the effective date of the revision of the
table; and</DELETED>
<DELETED> ``(2) either--</DELETED>
<DELETED> ``(A) the petition satisfies the
conditions described in subsection (a); or</DELETED>
<DELETED> ``(B) the date of the occurrence of the
first symptom or manifestation of onset of the injury
occurred more than 4 years before the petition is
filed, and the petition is filed not more than 2 years
after the effective date of the revision of the
table.''.</DELETED>
<DELETED> (c) Derivative Petitions.--Section 2116 of the Public
Health Service Act (42 U.S.C. 300aa-16) is amended by adding at the end
the following:</DELETED>
<DELETED> ``(d) Derivative Petitions.--No derivative petition may be
filed for compensation under the Program later than the earlier of--
</DELETED>
<DELETED> ``(1) the last day on which the petition for
compensation for the underlying claim of the person who
sustained the vaccine-related injury or death upon which the
derivative petition is premised may be timely filed;
or</DELETED>
<DELETED> ``(2) 60 days after the date on which the special
master has issued a decision pursuant to section 2112(d)(3) on
the underlying claim of the person who sustained the vaccine-
related injury or death upon which the derivative petition is
premised.''.</DELETED>
<DELETED> (d) Timely Resolutions of Claims.--</DELETED>
<DELETED> (1) Special master decision.--Section
2112(d)(3)(A) of the Public Health Service Act (42 U.S.C.
300aa-12(d)(3)(A)) is amended by adding at the end the
following: ``For purposes of this subparagraph, the petition
shall be deemed to be filed on the date on which the special
master issues a certificate of completeness, indicating that
all petition contents and supporting documents required under
section 2111(c) and, when applicable, section 2111(d) and the
Vaccine Rules of the United States Court of Federal Claims,
such as an affidavit and supporting documentation, have been
served on the Secretary and filed with the clerk of the United
States Court of Federal Claims.''.</DELETED>
<DELETED> (2) Derivative petitions.--Section 2112(d)(3)(C)
of the Public Health Service Act (42 U.S.C. 300aa-12(d)(3)(C))
is amended by adding at the end the following: ``With respect
to any derivative petition filed under section 2111, the period
of time during which the petition for compensation for the
underlying vaccine-related injury or death upon which such
derivative petition is premised is pending shall be treated as
a suspension for purposes of this subparagraph.''.</DELETED>
<DELETED> (3) Court of federal claims decision.--Section
2121(b) of the Public Health Service Act (42 U.S.C. 300aa-
21(b)) is amended by adding at the end the following: ``For
purposes of this subsection, the petition shall be deemed to be
filed on the date on which the special master issues a
certificate of completeness, indicating that all petition
contents and supporting documents required under section
2111(c) and, when applicable, section 2111(d) and the Vaccine
Rules of the United States Court of Federal Claims, such as an
affidavit and supporting documentation, have been served on the
Secretary and filed with the clerk of the United States Court
of Federal Claims.''.</DELETED>
<DELETED>SEC. 332. ADVISORY COMMISSION ON CHILDHOOD VACCINES.</DELETED>
<DELETED> (a) Selection of Persons Injured by Vaccines as Public
Members.--Section 2119(a)(1)(B) of the Public Health Service Act (42
U.S.C. 300aa-19(a)(1)(B)) is amended by striking ``of whom'' and all
that follows and inserting the following: ``of whom 1 shall be the
legal representative of a child who has suffered a vaccine-related
injury or death, and at least 1 other shall be either the legal
representative of a child who has suffered a vaccine-related injury or
death or an individual who has personally suffered a vaccine-related
injury.''.</DELETED>
<DELETED> (b) Mandatory Meeting Schedule Eliminated.--Section
2119(c) of the Public Health Service Act (42 U.S.C. 300aa-19(c)) is
amended by striking ``not less often than four times per year
and''.</DELETED>
<DELETED>SEC. 333. CLARIFICATION OF STANDARDS OF
RESPONSIBILITY.</DELETED>
<DELETED> (a) General Rule.--Section 2122(a) of the Public Health
Service Act (42 U.S.C. 300aa-22(a)) is amended by striking ``and (e)
State law shall apply to a civil action brought for damages'' and
inserting ``(d), and (f) State law shall apply to a civil action
brought for damages or equitable relief''; and</DELETED>
<DELETED> (b) Unavoidable Adverse Side Effects.--Section 2122(b)(1)
of the Public Health Service Act (42 U.S.C. 300aa-22(b)(1)) is amended
by inserting ``or equitable relief'' after ``for damages''.</DELETED>
<DELETED> (c) Direct Warnings.--Section 2122(c) of the Public Health
Service Act (42 U.S.C. 300aa-22(c)) is amended by inserting ``or
equitable relief'' after ``for damages''.</DELETED>
<DELETED> (d) Construction.--Section 2122(d) of the Public Health
Service Act (42 U.S.C. 300aa-22(d)) is amended--</DELETED>
<DELETED> (1) by inserting ``or equitable relief'' after
``for damages''; and</DELETED>
<DELETED> (2) by inserting ``or relief'' after ``which
damages''.</DELETED>
<DELETED> (e) Past or Present Physical Injury.--Section 2122 of the
Public Health Service Act (42 U.S.C. 300aa-22) is amended--</DELETED>
<DELETED> (1) by redesignating subsections (d) and (e) as
subsections (e) and (f), respectively; and</DELETED>
<DELETED> (2) by inserting after subsection (c) the
following:</DELETED>
<DELETED> ``(d) Past or Present Physical Injury.--No vaccine
manufacturer or vaccine administrator shall be liable in a civil action
brought after October 1, 1988, for equitable or monetary relief absent
proof of past or present physical injury from the administration of a
vaccine, nor shall any vaccine manufacturer or vaccine administrator be
liable in any such civil action for claims of medical monitoring, or
increased risk of harm.''.</DELETED>
<DELETED>SEC. 334. CLARIFICATION OF DEFINITION OF
MANUFACTURER.</DELETED>
<DELETED> Section 2133(3) of the Public Health Service Act (42
U.S.C. 300aa-33(3)) is amended--</DELETED>
<DELETED> (1) in the first sentence, by striking ``under its
label any vaccine set forth in the Vaccine Injury Table'' and
inserting ``any vaccine set forth in the Vaccine Injury table,
including any component or ingredient of any such vaccine'';
and</DELETED>
<DELETED> (2) in the second sentence, by inserting
``including any component or ingredient of any such vaccine''
before the period.</DELETED>
<DELETED>SEC. 335. CLARIFICATION OF DEFINITION OF VACCINE-RELATED
INJURY OR DEATH.</DELETED>
<DELETED> Section 2133(5) of the Public Health Service Act (42
U.S.C. 300aa-33(5)) is amended by adding at the end the following:
``For purposes of the preceding sentence, an adulterant or contaminant
shall not include any component or ingredient listed in a vaccine's
product license application or product label.''.</DELETED>
<DELETED>SEC. 336. CLARIFICATION OF DEFINITION OF VACCINE AND
DEFINITION OF PHYSICAL INJURY.</DELETED>
<DELETED> Section 2133 of the Public Health Service Act (42 U.S.C.
300aa-33) is amended by adding at the end the following:</DELETED>
<DELETED> ``(7) The term `vaccine' means any preparation or
suspension, including a preparation or suspension containing an
attenuated or inactive microorganism or subunit thereof or toxin,
developed or administered to produce or enhance the body's immune
response to a disease or diseases and includes all components and
ingredients listed in the vaccine's product license application and
product label.</DELETED>
<DELETED> ``(8) The term `physical injury' means a manifest physical
illness, condition, or death, including a neurological disease or
disorder.''.</DELETED>
<DELETED>SEC. 337. AMENDMENTS TO VACCINE INJURY COMPENSATION TRUST
FUND.</DELETED>
<DELETED> (a) Expansion of Compensated Loss.--Section 9510(c)(1)(A)
of the Internal Revenue Code of 1986 is amended by inserting ``, or
related loss,'' after ``death''.</DELETED>
<DELETED> (b) Increase in Limit on Administrative Expenses.--
Subparagraph (B) of section 9510(c)(1) of the Internal Revenue Code of
1986 is amended--</DELETED>
<DELETED> (1) by striking ``(but not in excess of the base
amount of $9,500,000 for any fiscal year)''; and</DELETED>
<DELETED> (2) by striking the period and inserting ``,
provided that such administrative costs shall not exceed the
greater of--</DELETED>
<DELETED> ``(i) the base amount of
$9,500,000 for any fiscal year,</DELETED>
<DELETED> ``(ii) 125 percent of the base
amount for any fiscal year in which the total
number of claims pending under such subtitle
exceeds 150 percent of the average number of
claims pending in the preceding 5
years,</DELETED>
<DELETED> ``(iii) 175 percent of the base
amount for any fiscal year in which the total
number of claims pending under such subtitle
exceeds 200 percent of the average number of
claims pending in the preceding 5
years,</DELETED>
<DELETED> ``(iv) 225 percent of the base
amount for any fiscal year in which the total
number of claims pending under such subtitle
exceeds 250 percent of the average number of
claims pending in the preceding 5 years,
or</DELETED>
<DELETED> ``(v) 275 percent of the base
amount for any fiscal year in which the total
number of claims pending under such subtitle
exceeds 300 percent of the average number of
claims pending in the preceding 5
years.''.</DELETED>
<DELETED> (c) Conforming Amendment.--Section 9510(c)(1)(A) of the
Internal Revenue Code of 1986 is amended by striking ``October 18,
2000'' and inserting ``the date of enactment of the Improved Vaccine
Affordability and Availability Act''.</DELETED>
<DELETED>SEC. 338. ONGOING REVIEW OF CHILDHOOD VACCINE DATA.</DELETED>
<DELETED> Part C of title XXI of the Public Health Service Act (42
U.S.C. 300a-25 et seq.) is amended by adding at the end the
following:</DELETED>
<DELETED>``SEC. 2129A. ONGOING REVIEW OF CHILDHOOD VACCINE
DATA.</DELETED>
<DELETED> ``(a) In General.--Not later than 6 months after the date
of enactment of this section, the Secretary shall enter into a contract
with the Institute of Medicine of the National Academy of Science under
which the Institute shall conduct an ongoing, comprehensive review of
new scientific data on childhood vaccines (according to priorities
agreed upon from time to time by the Secretary and the Institute of
Medicine).</DELETED>
<DELETED> ``(b) Reports.--Not later than 3 years after the date on
which the contract is entered into under subsection (a), the Institute
of Medicine shall submit to the Secretary a report on the findings of
the studies conducted under such contract, including findings as to any
adverse events associated with childhood vaccines, including
conclusions concerning causation of adverse events by such vaccines,
and other appropriate recommendations, based on such findings and
conclusions.</DELETED>
<DELETED> ``(c) Failure to Enter Into Contract.--If the Secretary
and the Institute of Medicine are unable to enter into the contract
described in subsection (a), the Secretary shall enter into a contract
with another qualified nongovernmental scientific organization for the
purposes described in subsections (a) and (b).</DELETED>
<DELETED> ``(d) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated such sums as may be
necessary for each of fiscal years 2003, 2004, 2005 and
2006.''.</DELETED>
<DELETED>SEC. 339. PENDING ACTIONS.</DELETED>
<DELETED> The amendments made by this title shall apply to all
actions or proceedings pending on or after the date of enactment of
this Act, unless a court of competent jurisdiction has entered judgment
(regardless of whether the time for appeal has expired) in such action
or proceeding disposing of the entire action or proceeding.</DELETED>
<DELETED>SEC. 340. REPORT.</DELETED>
<DELETED> Not later than 1 year after the date of enactment of this
Act, and annually thereafter, the Advisory Commission on Childhood
Vaccines shall report to the Secretary regarding the status of the
Vaccine Injury Compensation Trust Fund, and shall make recommendations
to the Secretary regarding the allocation of funds from the Vaccine
Injury Compensation Trust Fund.</DELETED>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Project BioShield Act of 2003''.
SEC. 2. BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT AUTHORITIES.
(a) In General.--Part B of title IV of the Public Health Service
Act (42 U.S.C. 284 et seq.) is amended by adding at the end the
following:
``SEC. 409J. BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT.
``(a) In General.--
``(1) Authority.--In carrying out research responsibilities
under this Act, the Secretary may conduct and support research
and development with respect to biomedical countermeasures.
``(2) Implementation.--
``(A) In general.--Except as provided in
subparagraph (C), authorities assigned by this section
to the Secretary shall be carried out through the
Director of NIH.
``(B) Lead institute.--The National Institute of
Allergy and Infectious Diseases shall be the lead
institute for performing, administering, or supporting
biomedical countermeasure research and development. The
Director of NIH may delegate to the Director of the
Institute authorities as are necessary to carry out
this function.
``(C) Chemical, radiological, and nuclear agents.--
To the extent that an authority described in
subparagraph (A) is exercised with respect to a
chemical, radiological, or nuclear agent, the Secretary
may authorize the Director of NIH to carry out the
authority through any national research institute.
``(D) Availability of facilities to the
secretary.--In any grant 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 preforming, administering, and
supporting biomedical countermeasures research and
development, the Secretary may provide that the
facility that is the object of such grant or
cooperative agreement shall be available as needed to
the Secretary to respond to public health emergencies
affecting national security.
``(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 Federal Government and to use other
agencies of the Department of Health and Human
Services.
``(B) Limitation.--An agreement or undertaking
under this paragraph may not authorize another agency
to exercise the authorities provided to the Secretary
by this section.
``(b) Expedited Procurement Authority.--
``(1) Increased simplified acquisition threshold for
biomedical 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 biomedical countermeasure
research or development, 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) Internal controls to be instituted.--The
Secretary shall institute appropriate internal controls
for procurements made under this paragraph, including
requirements with respect to documenting the
justification for use of the authority provided in this
paragraph.
``(2) Use of noncompetitive procedures.--In addition to any
other authority to use procedures other than competitive
procedures for procurements, the Secretary may use such other
noncompetitive procedures when--
``(A) the procurement is as described by paragraph
(1)(A); and
``(B) the property or services needed by the
Secretary 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
meet the needs of the Secretary.
``(3) Increased micropurchase threshold.--
``(A) In general.--For a procurement described by
paragraph (1)(A), 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 procurements that are made 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 Federal Government purchase card
method for purchases shall apply to procurements made
under this paragraph and that are greater than $2,500.
``(c) Authority To Expedite Peer Review.--The Secretary may, as the
Secretary determines necessary to respond to pressing 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, determines
to be appropriate to obtain an assessment of scientific and technical
merit and likely contribution to the field of biomedical countermeasure
research, in place of the peer review and advisory council review
procedures that would otherwise 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--
``(1) that is for performing, administering, or supporting
biomedical countermeasure research and development; and
``(2) the amount of which is not greater than $1,500,000.
``(d) Agency Facilities.--In addition to any similar authority
provided under any other provision of law, in carrying out this
section, the Secretary may--
``(1) acquire, lease, construct, improve, renovate,
remodel, repair, operate, and maintain laboratories, other
research facilities and equipment, and other real or personal
property as the Secretary determines necessary for the purpose
of performing, administering, and supporting biomedical
countermeasure research and development; and
``(2) acquire, without regard to section 8141 of title 40,
United States Code, by lease or otherwise, through the
Administrator of General Services, buildings or parts of
buildings in the District of Columbia.
``(e) Authority for Personal Services Contracts.--
``(1) In general.--For the purpose of performing,
administering, and supporting biomedical countermeasure
research and development, the Secretary may, as the Secretary
determines necessary to respond to pressing 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.
``(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 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 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 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 person, officer, employee, or
governing board member to carry out any
obligation or responsibility assumed by such
person, officer, employee, or governing board
member 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, officer, employee, or
governing board member.
``(ii) Venue.--The United States may
maintain an action under this subparagraph
against such person, officer, employee, or
governing board member in the district court of
the United States in which such person,
officer, employee, or governing board member
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.
``(f) 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 research and development needs
under this section, without regard to such 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
biomedical countermeasure research and development in carrying
out this section.
``(2) Internal controls to be instituted.--The Secretary
shall institute appropriate internal controls for appointments
under this subsection.
``(g) Definition.--As used in this section, the term `biomedical
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 is used--
``(1) to treat, identify, or prevent harm from any
biological, chemical, radiological, or nuclear agent that may
cause a public health emergency affecting national security; or
``(2) to treat, identify, or prevent 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 paragraph (1).
``(h) Actions Committed to Agency Discretion.--Actions by the
Secretary under the authority of this section are committed to agency
discretion.''.
(b) Technical Amendment.--Section 481A of the Public Health Service
Act (42 U.S.C. 287a-2) is amended--
(1) in subsection (a)(1), by inserting ``or the Director of
the National Institute of Allergy and Infectious Diseases''
after ``Director of the Center'';
(2) in subsection (c)--
(A) in paragraph (1), by inserting ``or the
Director of the National Institute of Allergy and
Infectious Diseases'' after ``Director of the Center'';
and
(B) in paragraph (2), in the matter preceding
subparagraph (A), by striking ``subsection (i)'' and
inserting ``subsection (i)(1)'';
(3) in subsection (d), by inserting ``or the Director of
the National Institute of Allergy and Infectious Diseases''
after ``Director of the Center'';
(4) in subsection (e)--
(A) in paragraph (1)--
(i) in the matter preceding subparagraph
(A), by inserting ``or the Director of the
National Institute of Allergy and Infectious
Diseases'' after ``Director of the Center'';
(ii) in subparagraph (A), by inserting
``(or, in the case of the Institute, 75
percent)'' after ``50 percent''; and
(iii) in subparagraph (B), by inserting
``(or, in the case of the Institute, 75
percent)'' after ``40 percent'';
(B) in paragraph (2), by inserting ``or the
Director of the National Institute of Allergy and
Infectious Diseases'' after ``Director of the Center'';
and
(C) in paragraph (4), by inserting ``of the Center
or the Director of the National Institute of Allergy
and Infectious Diseases'' after ``Director''; and
(5) in subsection (f)--
(A) in paragraph (1), by inserting ``in the case of
an award by the Director of the Center,'' before ``the
applicant''; and
(B) in paragraph (2), by inserting ``of the Center
or the Director of the National Institute of Allergy
and Infectious Diseases'' after ``Director''.
SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.) is amended by inserting after section 319A, the following:
``SEC. 319A-1. BIOMEDICAL COUNTERMEASURES PROCUREMENT.
``(a) Determination of Material Threats.--
``(1) Risk of use.--The Secretary of Homeland Security, in
consultation with the heads of other agencies as appropriate,
shall on an ongoing basis--
``(A) assess current and emerging threats of use of
chemical, biological, radiological, and nuclear agents;
and
``(B) determine which of such agents present a
material risk of use against the United States
population.
``(2) Public health impact.--The Secretary, in consultation
with the Secretary of Homeland Security, shall on an ongoing
basis--
``(A) assess the potential public health
consequences of use against the United States
population of agents identified under paragraph (1)(B);
and
``(B) determine, on the basis of such assessment,
the agents for which countermeasures are necessary to
protect the public health.
``(b) Assessment of Availability and Appropriateness of
Countermeasures.--The Secretary, in consultation with the Secretary of
Homeland Security, shall assess on an ongoing basis the availability
and appropriateness of specific countermeasures to address specific
threats identified under subsection (a).
``(c) Call for Necessary Countermeasures; Commitment for
Recommendation for Procurement.--
``(1) Proposal to the president.--Based on a determination
of necessary countermeasures under subsection (a), and the
assessment of availability and appropriateness of
countermeasures under subsection (b), the Secretary of Homeland
Security and the Secretary may jointly submit to the President
a proposal to--
``(A) call for a necessary countermeasure that is
not available; and
``(B) commit to make a recommendation for
procurement under subsection (e) of the first such
specific countermeasure that meets the conditions for
procurement under subsection (d).
``(2) Countermeasure specifications.--The Secretary of
Homeland Security and the Secretary shall, to the extent
practicable, include in the recommendation under paragraph
(1)--
``(A) estimated quantity of purchase (in the form
of number of doses or number of effective courses of
treatments regardless of dosage form);
``(B) necessary measures of minimum safety and
effectiveness;
``(C) estimated price for each dose or effective
course of treatment regardless of dosage form; and
``(D) other information that may be necessary to
encourage and facilitate research, development, and
manufacture of the countermeasure or to provide
specifications for the countermeasure.
``(3) Presidential approval.--If the President has approved
a request under paragraph (1), the Secretary of Homeland
Security and the Secretary shall make known to persons who may
respond to a call for the countermeasure--
``(A) the call for the countermeasure;
``(B) specifications for the countermeasure under
paragraph (2); and
``(C) a commitment for a recommendation for
procurement under subsection (e) of the first such
specific countermeasure that meets the conditions for
procurement under subsection (d) and the specifications
under paragraph (2).
``(4) Subsequent specific countermeasures.--Procurement
under subsection (f) of the first such specific countermeasure,
or any other such countermeasure, that meets the conditions for
procurement under subsection (d) and the specifications under
paragraph (2) shall not preclude the additional procurement
under subsection (f) of a subsequent such countermeasure that
meets the conditions of procurement under subsection (d) if
such a 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.
``(d) Secretary's Determination of Countermeasures Appropriate for
Procurement under this Section.--
``(1) In general.--The Secretary, in accordance with this
section, shall identify specific countermeasures to threats
identified under subsection (a) that the Secretary determines,
in consultation with the Secretary of Homeland Security, to be
appropriate for procurement with appropriations under this
subsection for inclusion in the stockpile under section 121(a)
of the Public Health and Bioterrorism Preparedness and Response
Act of 2002 (42 U.S.C. 300hh-12(a)).
``(2) Requirements.--In order for the Secretary to make the
determination under paragraph (1) with respect to a
countermeasure, the following requirements must be met:
``(A) Determination of qualified countermeasure.--
The Secretary must determine that the product is a
qualified countermeasure (as defined in subsection
(h)).
``(B) Determination of quantities needed and
feasibility of production and distribution.--The
Secretary must determine--
``(i) the quantities of the product that
will be needed to meet the needs of the
stockpile; and
``(ii) that production and delivery within
5 years of sufficient quantities of the
product, as so determined, is reasonably
expected to be feasible.
``(C) Determination of no significant commercial
market.--The Secretary shall--
``(i) determine that, at the time of the
initial determination under this subsection,
there is not a significant commercial market
for the product other than as a biomedical
countermeasure; and
``(ii) annually redetermine and report to
the President, while a determination under
paragraph (1) remains in effect with respect to
the product, whether a significant commercial
market exists for the product other than as a
biomedical countermeasure.
``(e) Recommendation for President's Approval.--
``(1) Recommendation for procurement.--In the case of a
countermeasure that the Secretary of Homeland Security and the
Secretary have determined is appropriate for procurement under
this section for inclusion in the stockpile, in accordance with
the preceding provisions of this section, the Secretary of
Homeland Security and the Secretary shall jointly submit to the
President, in coordination with the Director of the Office of
Management and Budget, a recommendation for procurement under
this section.
``(2) Presidential approval.--A countermeasure may be
procured under this section only if the President has approved
a recommendation under paragraph (1) with respect to such
countermeasure.
``(3) Notice to congress.--The Secretary of Homeland
Security shall notify Congress of each decision of the
President to approve a recommendation under paragraph (1).
``(f) Procurement.--The Secretary and the Secretary of Homeland
Security shall be responsible for the following, for purposes of
procurement of qualified countermeasures for the stockpile under
section 121(a) of the Public Health and Bioterrorism Preparedness and
Response Act of 2002 (42 U.S.C. 300hh-12(a)), as approved by the
President under subsection (e):
``(1) In general.--The Secretary shall be responsible for--
``(A) arranging for procurement of the
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 paragraph; and
``(B) promulgating regulations to implement
subparagraphs (E), (F), and (G), and any other
provisions of this section.
``(2) Contract terms.--A contract for procurement under
this section shall (or, as otherwise specified in this
paragraph, may) include the following terms:
``(A) Payment conditioned on substantial
delivery.--The contract shall provide that no payment
may be made until delivery has been made of a
substantial portion (as determined by the Secretary) of
the total number of units contracted for.
``(B) Discounted payment for unlicensed product.--
The contract may provide for a discounted price per
unit of a product that is not licensed or approved as
described in subsection (h)(1) at the time of delivery,
and may provide for payment of an additional amount per
unit if the product becomes so licensed 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 or
approval).
``(C) Storage by vendor.--The contract may provide
that the vendor will provide storage for stocks of a
product delivered to the ownership of the Government
under the contract, for such period and under such
terms and conditions as the Secretary may specify, and
in such case amounts appropriated under subsection (i)
shall be available for costs of shipping, handling,
storage, and related costs for such product.
``(D) Contract duration.--The contract shall be for
a period not to exceed 5 years, renewable for
additional periods none of which shall exceed 5 years.
``(E) Termination for nondelivery.--In addition to
any other rights of the Secretary to terminate the
contract, the contract may provide that such Secretary
may terminate the contract for failure to deliver a
reasonable number (as determined by the Secretary) of
units of the product by 3 years after the date the
contract is entered into, and may further provide that
in such case the vendor shall not be entitled to any
payment under the contract.
``(F) 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 of all of this
contract term on request of the vendor or on the
initiative of the Secretary.
``(3) Availability of simplified acquisition procedures.--
The amount of any procurement under this section 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--
``(A) 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
``(B) section 302A(b) of such Act (41 U.S.C.
252a(b)) and its implementing regulations.
``(4) Use of noncompetitive procedures.--In addition to any
other authority to use procedures other than competitive
procedures, the Secretary may use such other procedures for a
procurement under this section if the product is available from
only one responsible source or only from a limited number of
responsible sources, and no other type of product will satisfy
such Secretary's needs.
``(5) Premium provision in multiple award contracts.--
``(A) In general.--If, under this section, the
Secretary enters into contracts with more than one
person to procure a countermeasure, such Secretary may,
notwithstanding any other provision of law, include in
each of such contracts a provision that--
``(i) identifies an increment of the total
quantity of countermeasure required, whether by
percentage or by numbers of units; and
``(ii) promises to pay one or more
specified premiums based on the priority of
such persons' production and delivery of the
increment identified under clause (i), in
accordance with the terms and conditions of the
contract.
``(B) Determination of government's requirement not
reviewable.--If the Secretary includes in each of a set
of contracts a provision as described in subparagraph
(A), such Secretary's determination of the total
quantity of countermeasure required, and any amendment
of such determination, is committed to agency
discretion.
``(6) 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.
``(7) Limiting competition to sources responding to request
for information.--In conducting a procurement under this
section, 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 such Secretary may so exclude such a
source.
``(g) Interagency Cooperation.--
``(1) In general.--In carrying out activities under this
section, the Secretary of Homeland Security and the Secretary
are authorized, subject to paragraph (2), to enter into
interagency agreements and other collaborative undertakings
with other agencies of the United States Government.
``(2) Limitation.--An agreement or undertaking under this
subsection shall not authorize another agency to exercise the
authorities provided by this section to the Secretary of
Homeland Security or to the Secretary.
``(h) Definitions.--In this section:
``(1) Qualified countermeasure.--The term `qualified
countermeasure' means a biomedical countermeasure--
``(A) that is approved under section 505(a) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or
licensed under section 351 of this Act (42 U.S.C. 262)
or that is approved under section 515 or cleared under
section 510(k) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360e and 360) for use as such a
countermeasure to a chemical, biological, radiological,
or nuclear agent identified as a material threat under
subsection (a); or
``(B) for which the Secretary determines that
sufficient and satisfactory clinical experience or
research data (including data, if available, from
preclinical and clinical trials) support a reasonable
conclusion that the product will qualify for approval
or licensing as such a countermeasure within 5 years
after the date of a determination under subsection (d).
``(2) Biomedical countermeasure.--The term `biomedical
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))), device (as that term is defined by
section 201(h) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321(h))), or biological product (as that term is defined
by section 351(i) of this Act (42 U.S.C. 262(i))) that is
used--
``(A) to treat, identify, or prevent harm from any
biological, chemical, radiological, or nuclear agent
that may cause a public health emergency affecting
national security; or
``(B) to treat, identify, or prevent harm from a
condition that may result in adverse health
consequences or death and may be caused by
administering a drug or biological product that is used
as described in subparagraph (A).
``(i) Appropriations.--
``(1) In general.-- There are appropriated, out of any
moneys in the Treasury not otherwise appropriated, for fiscal
year 2003 and for each fiscal year thereafter, such sums as may
be necessary for the costs incurred by the Secretary in the
procurement of countermeasures under this subsection as
approved by the President under subsection (e) (other than
costs specified in paragraph (2)).
``(2) Restrictions.--Amounts appropriated under this
subsection shall not be available to pay--
``(A) costs for the purchase of vaccines under
procurement contracts entered into before January 1,
2003;
``(B) costs under new contracts, or costs of new
obligations under contracts previously entered into,
for procurement of a countermeasure after the date of a
determination under subsection (d)(2)(C) that there is
a significant commercial market for the countermeasure
other than as a biomedical countermeasure; or
``(C) administrative costs.''.
SEC. 4. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.
(a) In General.--Subchapter E of Chapter V of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360bbb, et seq.) is amended by adding
at the end the following:
``SEC. 564. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.
``(a) In General.--Notwithstanding sections 505, 510(k), and 515 of
this Act and section 351 of the Public Health Service Act, and subject
to the provisions of this section, the Secretary may authorize the
introduction into interstate commerce, during the effective period of a
declaration under subsection (b), of a drug, biological product, or
device intended solely for use in an actual or potential emergency.
``(b) Declaration of Emergency.--
``(1) In general.--The Secretary may declare an emergency
justifying the authorization of a drug, biological product, or
device under this subsection on the basis of a determination--
``(A) by the Secretary of Homeland Security, that
there is a domestic emergency (or a significant
potential of a domestic emergency) involving a
heightened risk of attack with a specified biological,
chemical, radiological, or nuclear agent;
``(B) by the Secretary of Defense, that there is a
military emergency (or a significant potential of a
military emergency) involving a heightened risk to
United States military forces of attack with a
biological, chemical, radiological, or nuclear agent;
or
``(C) by the Secretary of a public health emergency
under section 319 of the Public Health Service Act,
affecting national security and involving a specified
biological, chemical, radiological, or nuclear agent or
a specified disease or condition that may be
attributable to such agent.
``(2) Termination of declaration.--
``(A) In general.--A declaration under this
subsection shall terminate upon the earlier of--
``(i) a determination by the Secretary, in
consultation as appropriate with the Secretary
of Homeland Security or the Secretary of
Defense, that the circumstances described in
paragraph (1) have ceased to exist; or
``(ii) the expiration of the 1-year period
beginning on the date on which the declaration
is made.
``(B) Renewal.--Notwithstanding subparagraph (A),
the Secretary may renew a declaration under this
subsection, and this paragraph shall apply to any such
renewal.
``(3) Notification.--The Secretary shall promptly publish
in the Federal Register, and shall notify the appropriate
committees of Congress concerning, each declaration,
determination, and renewal under this subsection.
``(c) Criteria for Issuance of Authorization.--The Secretary may
issue an authorization under this section with respect to a product if
the Secretary concludes--
``(1) that an agent specified in a declaration under
subsection (b) can cause a serious or life-threatening disease
or condition;
``(2) that, based on the totality of scientific evidence
available to the Secretary, including data from adequate and
well-controlled clinical trials, if available, it is reasonable
to believe that--
``(A) the product may be effective in detecting,
diagnosing, treating, or preventing--
``(i) such disease or condition; or
``(ii) a serious or life-threatening
disease or condition caused by a product
authorized under this section or approved under
this Act or the Public Health Service Act, for
detecting, diagnosing, treating, or preventing
such a disease or condition caused by such an
agent; and
``(B) the known and potential benefits of the
product, when used to detect, diagnose, prevent, or
treat such disease or condition, outweigh the known and
potential risks of the product;
``(3) that there is no adequate, approved, and available
alternative to the product for detecting, diagnosing,
preventing, or treating such disease or condition; and
``(4) that such other criteria as the Secretary may by
regulation prescribe are satisfied.
``(d) Scope of Authorization.--An authorization of a product under
this section shall state--
``(1) each disease or condition and the intended use of the
product within the scope of the authorization; and
``(2) the Secretary's conclusions, under subsection (c),
concerning the safety and potential effectiveness of the
product in detecting, diagnosing, preventing, or treating such
diseases or conditions, including an assessment of the
available scientific evidence.
``(e) Conditions of Authorization.--The Secretary is authorized to
impose such conditions on an authorization under this section as the
Secretary determines are necessary or appropriate to protect the public
health, including the following:
``(1) The Secretary shall impose requirements (including
requirements concerning product labeling and the provision of
information) designed to ensure that, to the maximum extent
feasible given the circumstances of the emergency, health care
professionals administering the product are informed--
``(A) that the Secretary has authorized the product
solely for emergency use;
``(B) of the significant known and potential
benefits and risks of use of the product, and of the
extent to which such benefits and risks are unknown;
and
``(C) of the alternatives to the product that are
available, and of their benefits and risks.
``(2) The Secretary shall impose requirements (including
requirements concerning product labeling and the provision of
information) designed to ensure that, to the maximum extent
feasible given the circumstances of the emergency, individuals
to whom the product is administered are informed--
``(A) that the Secretary has authorized the product
solely for emergency use;
``(B) of the significant known and potential
benefits and risks of use of the product, and of the
extent to which such benefits and risks are unknown;
and
``(C) of any option to accept or refuse
administration of the product, and of the alternatives
to the product that are available and of their benefits
and risks.
``(3) The Secretary may impose limitations on which
entities may distribute the product (including limitation to
distribution by government entities), and on how distribution
is to be performed.
``(4) The Secretary may impose limitations on who may
administer the product, and on the categories of individuals to
whom, and the circumstances under which, the product may be
administered.
``(5) The Secretary may condition the authorization on the
performance of studies, clinical trials, or other research
needed to support marketing approval of the product.
``(6) The Secretary shall impose, to the extent feasible
and appropriate given the circumstances of the emergency,
requirements concerning recordkeeping and reporting, including
records access by the Secretary and publication of data.
``(7) The Secretary may waive, to the extent appropriate
given the circumstances of the emergency, requirements, with
respect to the product, of current good manufacturing practice
otherwise applicable to the manufacture, processing, packing,
or holding of products subject to regulation under this Act.
``(8) The Secretary shall, to the extent feasible and
appropriate given the circumstances of the emergency, impose
requirements for the monitoring and reporting of adverse events
associated with use of the product.
``(f) Duration of Authorization.--
``(1) In general.--Except as provided in paragraph (2), an
authorization under this section shall be effective until the
earlier of the termination of the declaration under subsection
(b) or a revocation under subsection (g).
``(2) Continued use after end of effective period.--An
authorization shall continue to be effective for continued use
with respect to patients to whom it was administered during the
period described by paragraph (1), to the extent found
necessary by such patients' attending physicians.
``(g) Revocation of Authorization.--
``(1) Review.--The Secretary shall periodically review the
circumstances and the appropriateness of an authorization under
this section.
``(2) Revocation.--The Secretary may revoke an
authorization under this section if, in the Secretary's
unreviewable discretion--
``(A) the conditions for such an authorization are
no longer met; or
``(B) other circumstances make such revocation
appropriate.
``(h) Publication.--The Secretary shall promptly publish in the
Federal Register, and provide to the appropriate committees of
Congress, a notice of each authorization, and each termination or
revocation of an authorization, under this section.
``(i) Recordkeeping.--
``(1) In general.--The Secretary may require persons,
including a person who holds an authorization under this
section, or who manufactures, distributes, prescribes, or
administers a product that is the subject of such an
authorization, to establish and maintain--
``(A) data that is obtained from such activity and
that pertains to the effectiveness or safety of such
product;
``(B) such records as are necessary to determine,
or facilitate a determination, whether there may be any
violation of this section or of a regulation
promulgated under this section; and
``(C) such additional records as the Secretary may
determine necessary.
``(2) Access to records by secretary.--
``(A) Safety and effectiveness information.--The
Secretary may require a person who holds an
authorization under this section, or who manufactures,
distributes, prescribes, or administers a product that
is the subject of such an authorization to provide to
the Secretary all data that is obtained from such
activity and that pertains to the safety or
effectiveness of such product.
``(B) Other information.--Every person required
under this section to establish or maintain records,
and every person in charge or custody of such records,
shall, upon request by the Secretary, permit the
Secretary at all reasonable times to have access to, to
copy, and to verify such records.
``(j) Civil Monetary Penalties.--
``(1) In general.--A person who violates a requirement of
this section or of a regulation or order promulgated pursuant
to this section shall be subject to a civil money penalty of
not more than $100,000 in the case of an individual, and not
more than $250,000 in the case of any other person, for each
violation, not to exceed $1,000,000 for all such violations
adjudicated in a single proceeding.
``(2) Assessment of civil penalties.--Paragraphs (3), (4),
and (5) of section 303(g) shall apply to a civil penalty under
this subsection, and references in such paragraphs to
`paragraph (1) or (2)' shall, for purposes of this subsection,
be deemed to refer to paragraph (1) of this subsection.
``(k) Actions Committed to Agency Discretion.--Actions under the
authority of this section by the Secretary, by the Secretary of
Defense, or by the Secretary of Homeland Security are committed to
agency discretion.
``(l) Regulations.--The Secretary may promulgate regulations to
implement this section.
``(m) Construction.--Nothing in this section shall be construed to
impair or otherwise affect--
``(1) the authority of the President as Commander in Chief
of the Armed Forces of the United States under article II,
section 2 of the United States Constitution; or
``(2) the authority of the Secretary of Defense with
respect to the Department of Defense, including the armed
forces, under other provisions of Federal law.
``(n) Application to Members of Armed Forces.--
``(1) Waiver of requirement relating to option to refuse.--
In the case of the administration of a countermeasure to
members of the armed forces, a requirement, under subsection
(e)(2), designed to ensure that individuals are informed of an
option to accept or refuse administration of a product, may be
waived by the President if the President determines, in
writing, that complying with such requirement is not feasible,
is contrary to the best interests of the members affected, or
is not in the interests of national security.
``(2) Effect on statute pertaining to investigational new
drugs.--In the case of an authorization based on a
determination by the Secretary of Defense under subsection
(b)(1)(B), section 1107 of title 10, United States Code, shall
not apply to use of a product that is the subject of such
authorization, within the scope of such authorization and while
such authorization is effective.
``(o) Relation to Other Provisions.--If a product is the subject of
an authorization under this section, the use of such product within the
scope of the authorization--
``(1) shall not be subject to any requirements pursuant to
section 505(i) or 520(g); and
``(2) shall not be subject to any requirements otherwise
applicable to clinical investigations pursuant to other
provisions of this Act.''.
(b) Prohibited Acts.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended--
(1) in subsection (e)--
(A) by striking ``504, 703'' and inserting ``504,
564, 703''; and
(B) by striking ``or 519'' and inserting ``519, or
564''; and
(2) by adding at the end the following:
``(hh)(1) Promotion or use of a product that is the subject of an
authorization under section 564 other than as stated in the
authorization, or other than during the period described by section
564(g), unless such promotion or use is permitted under another
provision of this Act.
``(2) Failure to comply with an information requirement under
section 564(e).''.
SEC. 5. AMENDMENTS TO PROVISIONS OF THE HOMELAND SECURITY ACT.
(a) Declaration Recommending Making Countermeasure Available to
Individuals.--Section 224(p)(2)(A)(i) of the Public Health Service Act
(42 U.S.C. 233(p)(2)(A)(i)) is amended--
(1) by striking ``advisable the administration'' and
inserting the following: ``advisable--
``(I) the administration'';
(2) by striking the period and inserting ``; or''; and
(3) by adding at the end the following:
``(II) making a covered
countermeasure available to a category
or categories of individuals who may
wish to receive it.''.
(b) Amendment to Accidental Vaccinia Inoculation Provision.--
Section 224(p)(2)(C)(ii)(II) of the Public Health Service Act (42
U.S.C. 233(p)(2)(C)(ii)(II)) is amended by striking ``resides or has
resided with'' and inserting ``has resided with, or has had close
contact with,''.
(c) Deeming Acts and Omissions to be Within Scope of Employment.--
Section 224(p)(2) of the Public Health Service Act (42 U.S.C.
233(p)(2)) is amended by adding at the end the following:
``(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 paragraph (2)(B); and
``(II) such individual was within a
category of individuals covered by a
declaration under paragraph
(2)(A)(i)(I).''.
(d) Requirement to Cooperate with United States.--Section 224(p)(5)
of the Public Health Service Act (42 U.S.C. 233(p)(5)) is amended in
paragraph heading by striking ``Defendant'' and inserting ``Covered
person''.
(e) Amendment to Definition of Covered Countermeasure.--Subclause
(II) of section 224(p)(7)(A)(i) of the Public Health Service Act (42
U.S.C. 233(p)(7)(A)(i)(II)) is amended to read as follows:
``(II) used to control or treat the
adverse effects of vaccinia inoculation
or of administration of another covered
countermeasure; and''.
(f) Amendment to Definition of Covered Person.--Section
224(p)(7)(B) of the Public Health Service Act (42 U.S.C. 233(p)(7)(B))
is amended--
(1) in the matter preceding clause (i), by striking
``includes any person'' and inserting ``means a person'';
(2) in clause (ii)--
(A) by striking ``auspices such'' and inserting the
following: ``auspices--
``(I) such''; and
(B) by adding at the end the following:
``(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 of a covered
countermeasure was monitored, managed,
or cared for; or
``(IV) an evaluation was made of
whether the administration of a covered
countermeasure was effective;'';
(3) in clause (iii) by striking ``or'';
(4) by striking clause (iv) and inserting the following:
``(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, or supplied technical or scientific
advice or assistance 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)(I); or
``(II) an entity that employs an
individual described by clause (I) or
where such individual has privileges 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
to provide health care under the auspices of an
entity described in clause (ii) or (v)(II).''.
(g) Amendment to Definition of Qualified Person.--Section
224(p)(7)(C) of the Public Health Service Act (42 U.S.C. 233(p)(7)(C))
is amended--
(1) by striking ``who is authorized to'' and inserting the
following: ``who--
``(i) is authorized to'';
(2) by striking the period and inserting ``; or''; and
(3) by adding at the end the following:
``(ii) is otherwise authorized by the
Secretary to administer such countermeasure.''.
(h) Definition of ``Arising Out of Administration of a Covered
Countermeasure''.--Section 224(p)(7) of the Public Health Service Act
(42 U.S.C. 233(p)(7)) is amended by adding at the end the following:
``(D) Arising out of administration of a covered
countermeasure.--
``(i) In general.--The term `arising out of
administration of a covered countermeasure',
when used with respect to a claim or liability,
includes, except as provided in clause (ii), 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 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).
``(ii) Exception.--Such term shall not
include a claim or liability arising out of
care for or treatment of complications arising
out of the administration of the
countermeasure.''.
(i) Technical Correction.--Section 224(p)(2)(A)(ii) of the Public
Health Service Act (42 U.S.C. 233(p)(2)(A)(ii)) is amended by striking
``paragraph (8)(A)'' and inserting ``paragraph (7)(A)''.
(j) Effective Date.--This amendments made by this section shall
take effect as if enacted on November 25, 2002.
SEC. 6. GAO REPORT.
Not later than 4 years after the date of enactment of this Act, the
Comptroller General of the United States shall submit to the
appropriate committees of Congress a report that--
(1) describes the activities conducted under the
authorities provided for in section 409J(b)(1) of the Public
Health Service Act (as added by section 2) and section 319A-
1(f)(3) and (4) of such Act (as added by section 3);
(2) identifies any procurements that would have been
prohibited except for the authorities provided in the sections
described in paragraph (1); and
(3) assesses the adequacy of the internal controls
established by the Secretary of Health and Human Services
regarding procurements made under the authorities provided for
in the sections described in paragraph (1).
Calendar No. 53
108th CONGRESS
1st Session
S. 15
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to provide for the payment of
compensation for certain individuals with injuries resulting from the
administration of smallpox countermeasures, to provide protections and
countermeasures against chemical, radiological, or nuclear agents that
may be used in a terrorist attack against the United States, and to
improve immunization rates by increasing the distribution of vaccines
and improving and clarifying the vaccine injury compensation program.
_______________________________________________________________________
March 25, 2003
Reported with an amendment