[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 1 Enrolled Bill (ENR)]
S.1
One Hundred Third Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday,
the fifth day of January, one thousand nine hundred and ninety-three
An Act
To amend the Public Health Service Act to revise and extend the
programs of
the National Institutes of Health, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``National Institutes
of Health Revitalization Act of 1993''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--GENERAL PROVISIONS REGARDING TITLE IV OF PUBLIC HEALTH SERVICE
ACT
Subtitle A--Research Freedom
Part I--Review of Proposals for Biomedical and Behavioral Research
Sec. 101. Establishment of certain provisions regarding research
conducted or supported by National Institutes of Health.
Part II--Research on Transplantation of Fetal Tissue
Sec. 111. Establishment of authorities.
Sec. 112. Purchase of human fetal tissue; solicitation or acceptance of
tissue as directed donation for use in transplantation.
Sec. 113. Nullification of moratorium.
Sec. 114. Report by General Accounting Office on adequacy of
requirements.
Part III--Miscellaneous Repeals
Sec. 121. Repeals.
Subtitle B--Clinical Research Equity Regarding Women and Minorities
Part I--Women and Minorities as Subjects in Clinical Research
Sec. 131. Requirement of inclusion in research.
Sec. 132. Peer review.
Sec. 133. Inapplicability to current projects.
Part II--Office of Research on Women's Health
Sec. 141. Establishment.
Part III--Office of Research on Minority Health
Sec. 151. Establishment.
Subtitle C--Research Integrity
Sec. 161. Establishment of Office of Research Integrity.
Sec. 162. Commission on Research Integrity.
Sec. 163. Protection of whistleblowers.
Sec. 164. Requirement of regulations regarding protection against
financial conflicts of interest in certain projects of research.
Sec. 165. Regulations.
TITLE II--NATIONAL INSTITUTES OF HEALTH IN GENERAL
Sec. 201. Health promotion research dissemination.
Sec. 202. Programs for increased support regarding certain States and
researchers.
Sec. 203. Establishment of Office of Behavioral and Social Sciences
Research.
Sec. 204. Children's vaccine initiative.
Sec. 205. Plan for use of animals in research.
Sec. 206. Increased participation of women and disadvantaged individuals
in fields of biomedical and behavioral research.
Sec. 207. Requirements regarding surveys of sexual behavior.
Sec. 208. Discretionary fund of Director of National Institutes of
Health.
Sec. 209. Establishment of Office of Alternative Medicine.
Sec. 210. Miscellaneous provisions.
TITLE III--GENERAL PROVISIONS RESPECTING NATIONAL RESEARCH INSTITUTES
Sec. 301. Appointment and authority of Directors of national research
institutes.
Sec. 302. Program of research on osteoporosis, Paget's disease, and
related bone disorders.
Sec. 303. Establishment of interagency program for trauma research.
TITLE IV--NATIONAL CANCER INSTITUTE
Sec. 401. Expansion and intensification of activities regarding breast
cancer.
Sec. 402. Expansion and intensification of activities regarding prostate
cancer.
Sec. 403. Authorization of appropriations.
TITLE V--NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
Sec. 501. Education and training.
Sec. 502. Centers for the study of pediatric cardiovascular diseases.
Sec. 503. National Center on Sleep Disorders Research.
Sec. 504. Authorization of appropriations.
Sec. 505. Prevention and control programs.
TITLE VI--NATIONAL INSTITUTE ON DIABETES AND DIGESTIVE AND KIDNEY
DISEASES
Sec. 601. Provisions regarding nutritional disorders.
TITLE VII--NATIONAL INSTITUTE ON ARTHRITIS AND MUSCULOSKELETAL AND SKIN
DISEASES
Sec. 701. Juvenile arthritis.
TITLE VIII--NATIONAL INSTITUTE ON AGING
Sec. 801. Alzheimer's disease registry.
Sec. 802. Aging processes regarding women.
Sec. 803. Authorization of appropriations.
Sec. 804. Conforming amendment.
TITLE IX--NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
Sec. 901. Tropical diseases.
Sec. 902. Chronic fatigue syndrome.
TITLE X--NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
Subtitle A--Research Centers With Respect to Contraception and Research
Centers With Respect to Infertility
Sec. 1001. Grants and contracts for research centers.
Sec. 1002. Loan repayment program for research with respect to
contraception and infertility.
Subtitle B--Program Regarding Obstetrics and Gynecology
Sec. 1011. Establishment of program.
Subtitle C--Child Health Research Centers
Sec. 1021. Establishment of centers.
Subtitle D--Study Regarding Adolescent Health
Sec. 1031. Prospective longitudinal study.
TITLE XI--NATIONAL EYE INSTITUTE
Sec. 1101. Clinical and health services research on eye care and
diabetes.
TITLE XII--NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
Sec. 1201. Research on multiple sclerosis.
TITLE XIII--NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
Sec. 1301. Applied Toxicological Research and Testing Program.
TITLE XIV--NATIONAL LIBRARY OF MEDICINE
Subtitle A--General Provisions
Sec. 1401. Additional authorities.
Sec. 1402. Authorization of appropriations.
Subtitle B--Financial Assistance
Sec. 1411. Establishment of program of grants for development of
education technologies.
Subtitle C--National Information Center on Health Services Research and
Health Care Technology
Sec. 1421. Establishment of Center.
Sec. 1422. Conforming provisions.
TITLE XV--OTHER AGENCIES OF NATIONAL INSTITUTES OF HEALTH
Subtitle A--Division of Research Resources
Sec. 1501. Redesignation of Division as National Center for Research
Resources.
Sec. 1502. Biomedical and behavioral research facilities.
Sec. 1503. Construction program for national primate research center.
Subtitle B--National Center for Nursing Research
Sec. 1511. Redesignation of National Center for Nursing Research as
National Institute of Nursing Research.
Sec. 1512. Study on adequacy of number of nurses.
Subtitle C--National Center for Human Genome Research
Sec. 1521. Purpose of Center.
TITLE XVI--AWARDS AND TRAINING
Subtitle A--National Research Service Awards
Sec. 1601. Requirement regarding women and individuals from
disadvantaged backgrounds.
Sec. 1602. Service payback requirements.
Subtitle B--Acquired Immune Deficiency Syndrome
Sec. 1611. Loan repayment program.
Subtitle C--Loan Repayment for Research Generally
Sec. 1621. Establishment of program.
Subtitle D--Scholarship and Loan Repayment Programs Regarding
Professional Skills Needed by Certain Agencies
Sec. 1631. Establishment of programs for National Institutes of Health.
Sec. 1632. Funding.
Subtitle E--Funding for Awards and Training Generally
Sec. 1641. Authorization of appropriations.
TITLE XVII--NATIONAL FOUNDATION FOR BIOMEDICAL RESEARCH
Sec. 1701. National Foundation for Biomedical Research.
TITLE XVIII--RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY
SYNDROME
Subtitle A--Office of AIDS Research
Sec. 1801. Establishment of Office.
Sec. 1802. Establishment of emergency discretionary fund.
Sec. 1803. General provisions.
Subtitle B--Certain Programs
Sec. 1811. Revision and extension of certain programs.
TITLE XIX--STUDIES
Sec. 1901. Life-threatening illnesses.
Sec. 1902. Malnutrition in the elderly.
Sec. 1903. Research activities on chronic fatigue syndrome.
Sec. 1904. Report on medical uses of biological agents in development of
defenses against biological warfare.
Sec. 1905. Personnel study of recruitment, retention and turnover.
Sec. 1906. Procurement.
Sec. 1907. Chronic pain conditions.
Sec. 1908. Relationship between the consumption of legal and illegal
drugs.
Sec. 1909. Reducing administrative health care costs.
Sec. 1910. Sentinel disease concept study.
Sec. 1911. Potential environmental and other risks contributing to
incidence of breast cancer.
Sec. 1912. Support for bioengineering research.
Sec. 1913. Cost of care in last 6 months of life.
TITLE XX--MISCELLANEOUS PROVISIONS
Sec. 2001. Designation of Senior Biomedical Research Service in honor of
Silvio O. Conte; limitation on number of members.
Sec. 2002. Master plan for physical infrastructure for research.
Sec. 2003. Certain authorization of appropriations.
Sec. 2004. Buy-American provisions.
Sec. 2005. Prohibition against further funding for Project Aries.
Sec. 2006. Loan repayment program.
Sec. 2007. Exclusion of aliens infected with the agent for acquired
immune deficiency syndrome.
Sec. 2008. Technical corrections.
Sec. 2009. Biennial report on carcinogens.
Sec. 2010. Transfer of provisions of title XXVII.
Sec. 2011. Authorization of appropriations.
Sec. 2012. Vaccine injury compensation program.
Sec. 2013. Technical corrections with respect to the Agency for Health
Care Policy and Research.
Sec. 2014. Technical corrections with respect to the Health Professions
Education Extension Amendments of 1992.
Sec. 2015. Prohibitions against SHARP adult sex survey and the American
teenage sex survey.
Sec. 2016. Health services research.
Sec. 2017. Childhood mental health.
Sec. 2018. Expenditures from certain account.
TITLE XXI--EFFECTIVE DATES
Sec. 2101. Effective dates.
TITLE I--GENERAL PROVISIONS REGARDING TITLE IV OF PUBLIC HEALTH SERVICE
ACT
Subtitle A--Research Freedom
PART I--REVIEW OF PROPOSALS FOR BIOMEDICAL AND BEHAVIORAL RESEARCH
SEC. 101. ESTABLISHMENT OF CERTAIN PROVISIONS REGARDING RESEARCH
CONDUCTED OR SUPPORTED BY NATIONAL INSTITUTES OF HEALTH.
Part G of title IV of the Public Health Service Act (42 U.S.C. 289
et seq.) is amended by inserting after section 492 the following
section:
``certain provisions regarding review and approval of proposals for
research
``Sec. 492A. (a) Review as Precondition to Research.--
``(1) Protection of human research subjects.--
``(A) In the case of any application submitted to the
Secretary for financial assistance to conduct research, the
Secretary may not approve or fund any application that is
subject to review under section 491(a) by an Institutional
Review Board unless the application has undergone review in
accordance with such section and has been recommended for
approval by a majority of the members of the Board conducting
such review.
``(B) In the case of research that is subject to review
under procedures established by the Secretary for the protection
of human subjects in clinical research conducted by the National
Institutes of Health, the Secretary may not authorize the
conduct of the research unless the research has, pursuant to
such procedures, been recommended for approval.
``(2) Peer review.--In the case of any proposal for the National
Institutes of Health to conduct or support research, the Secretary
may not approve or fund any proposal that is subject to technical
and scientific peer review under section 492 unless the proposal has
undergone such review in accordance with such section and has been
recommended for approval by a majority of the members of the entity
conducting such review.
``(b) Ethical Review of Research.--
``(1) Procedures regarding withholding of funds.--If research
has been recommended for approval for purposes of subsection (a),
the Secretary may not withhold funds for the research because of
ethical considerations unless--
``(A) the Secretary convenes an advisory board in accordance
with paragraph (5) to study such considerations; and
``(B)(i) the majority of the advisory board recommends that,
because of such considerations, the Secretary withhold funds for
the research; or
``(ii) the majority of such board recommends that the
Secretary not withhold funds for the research because of such
considerations, but the Secretary finds, on the basis of the
report submitted under paragraph (5)(B)(ii), that the
recommendation is arbitrary and capricious.
``(2) Rules of construction.--Paragraph (1) may not be construed
as prohibiting the Secretary from withholding funds for research on
the basis of--
``(A) the inadequacy of the qualifications of the entities
that would be involved with the conduct of the research
(including the entity that would directly receive the funds from
the Secretary), subject to the condition that, with respect to
the process of review through which the research was recommended
for approval for purposes of subsection (a), all findings
regarding such qualifications made in such process are
conclusive; or
``(B) the priorities established by the Secretary for the
allocation of funds among projects of research that have been so
recommended.
``(3) Applicability.--The limitation established in paragraph
(1) regarding the authority to withhold funds because of ethical
considerations shall apply without regard to whether the withholding
of funds on such basis is characterized as a disapproval, a
moratorium, a prohibition, or other characterization.
``(4) Preliminary matters regarding use of procedures.--
``(A) If the Secretary makes a determination that an
advisory board should be convened for purposes of paragraph (1),
the Secretary shall, through a statement published in the
Federal Register, announce the intention of the Secretary to
convene such a board.
``(B) A statement issued under subparagraph (A) shall
include a request that interested individuals submit to the
Secretary recommendations specifying the particular individuals
who should be appointed to the advisory board involved. The
Secretary shall consider such recommendations in making
appointments to the board.
``(C) The Secretary may not make appointments to an advisory
board under paragraph (1) until the expiration of the 30-day
period beginning on the date on which the statement required in
subparagraph (A) is made with respect to the board.
``(5) Ethics advisory boards.--
``(A) Any advisory board convened for purposes of paragraph
(1) shall be known as an ethics advisory board (in this
paragraph referred to as an `ethics board').
``(B)(i) An ethics board shall advise, consult with, and
make recommendations to the Secretary regarding the ethics of
the project of biomedical or behavioral research with respect to
which the board has been convened.
``(ii) Not later than 180 days after the date on which the
statement required in paragraph (4)(A) is made with respect to
an ethics board, the board shall submit to the Secretary, and to
the Committee on Energy and Commerce of the House of
Representatives and the Committee on Labor and Human Resources
of the Senate, a report describing the findings of the board
regarding the project of research involved and making a
recommendation under clause (i) of whether the Secretary should
or should not withhold funds for the project. The report shall
include the information considered in making the findings.
``(C) An ethics board shall be composed of no fewer than 14,
and no more than 20, individuals who are not officers or
employees of the United States. The Secretary shall make
appointments to the board from among individuals with special
qualifications and competence to provide advice and
recommendations regarding ethical matters in biomedical and
behavioral research. Of the members of the board--
``(i) no fewer than 1 shall be an attorney;
``(ii) no fewer than 1 shall be an ethicist;
``(iii) no fewer than 1 shall be a practicing physician;
``(iv) no fewer than 1 shall be a theologian; and
``(v) no fewer than one-third, and no more than one-
half, shall be scientists with substantial accomplishments
in biomedical or behavioral research.
``(D) The term of service as a member of an ethics board
shall be for the life of the board. If such a member does not
serve the full term of such service, the individual appointed to
fill the resulting vacancy shall be appointed for the remainder
of the term of the predecessor of the individual.
``(E) A member of an ethics board shall be subject to
removal from the board by the Secretary for neglect of duty or
malfeasance or for other good cause shown.
``(F) The Secretary shall designate an individual from among
the members of an ethics board to serve as the chair of the
board.
``(G) In carrying out subparagraph (B)(i) with respect to a
project of research, an ethics board shall conduct inquiries and
hold public hearings.
``(H) In carrying out subparagraph (B)(i) with respect to a
project of research, an ethics board shall have access to all
relevant information possessed by the Department of Health and
Human Services, or available to the Secretary from other
agencies.
``(I) Members of an ethics board shall receive compensation
for each day engaged in carrying out the duties of the board,
including time engaged in traveling for purposes of such duties.
Such compensation may not be provided in an amount in excess of
the maximum rate of basic pay payable for GS-18 of the General
Schedule.
``(J) The Secretary, acting through the Director of the
National Institutes of Health, shall provide to each ethics
board reasonable staff and assistance to carry out the duties of
the board.
``(K) An ethics board shall terminate 30 days after the date
on which the report required in subparagraph (B)(ii) is
submitted to the Secretary and the congressional committees
specified in such subparagraph.
``(6) Definition.--For purposes of this subsection, the term
`ethical considerations' means considerations as to whether the
nature of the research involved is such that it is unethical to
conduct or support the research.''.
PART II--RESEARCH ON TRANSPLANTATION OF FETAL TISSUE
SEC. 111. ESTABLISHMENT OF AUTHORITIES.
Part G of title IV of the Public Health Service Act (42 U.S.C. 289
et seq.) is amended by inserting after section 498 the following
section:
``research on transplantation of fetal tissue
``Sec. 498A. (a) Establishment of Program.--
``(1) In general.--The Secretary may conduct or support research
on the transplantation of human fetal tissue for therapeutic
purposes.
``(2) Source of tissue.--Human fetal tissue may be used in
research carried out under paragraph (1) regardless of whether the
tissue is obtained pursuant to a spontaneous or induced abortion or
pursuant to a stillbirth.
``(b) Informed Consent of Donor.--
``(1) In general.--In research carried out under subsection (a),
human fetal tissue may be used only if the woman providing the
tissue makes a statement, made in writing and signed by the woman,
declaring that--
``(A) the woman donates the fetal tissue for use in research
described in subsection (a);
``(B) the donation is made without any restriction regarding
the identity of individuals who may be the recipients of
transplantations of the tissue; and
``(C) the woman has not been informed of the identity of any
such individuals.
``(2) Additional statement.--In research carried out under
subsection (a), human fetal tissue may be used only if the attending
physician with respect to obtaining the tissue from the woman
involved makes a statement, made in writing and signed by the
physician, declaring that--
``(A) in the case of tissue obtained pursuant to an induced
abortion--
``(i) the consent of the woman for the abortion was
obtained prior to requesting or obtaining consent for a
donation of the tissue for use in such research;
``(ii) no alteration of the timing, method, or
procedures used to terminate the pregnancy was made solely
for the purposes of obtaining the tissue; and
``(iii) the abortion was performed in accordance with
applicable State law;
``(B) the tissue has been donated by the woman in accordance
with paragraph (1); and
``(C) full disclosure has been provided to the woman with
regard to--
``(i) such physician's interest, if any, in the research
to be conducted with the tissue; and
``(ii) any known medical risks to the woman or risks to
her privacy that might be associated with the donation of
the tissue and that are in addition to risks of such type
that are associated with the woman's medical care.
``(c) Informed Consent of Researcher and Donee.--In research carried
out under subsection (a), human fetal tissue may be used only if the
individual with the principal responsibility for conducting the research
involved makes a statement, made in writing and signed by the
individual, declaring that the individual--
``(1) is aware that--
``(A) the tissue is human fetal tissue;
``(B) the tissue may have been obtained pursuant to a
spontaneous or induced abortion or pursuant to a stillbirth; and
``(C) the tissue was donated for research purposes;
``(2) has provided such information to other individuals with
responsibilities regarding the research;
``(3) will require, prior to obtaining the consent of an
individual to be a recipient of a transplantation of the tissue,
written acknowledgment of receipt of such information by such
recipient; and
``(4) has had no part in any decisions as to the timing, method,
or procedures used to terminate the pregnancy made solely for the
purposes of the research.
``(d) Availability of Statements for Audit.--
``(1) In general.--In research carried out under subsection (a),
human fetal tissue may be used only if the head of the agency or
other entity conducting the research involved certifies to the
Secretary that the statements required under subsections (b)(2) and
(c) will be available for audit by the Secretary.
``(2) Confidentiality of audit.--Any audit conducted by the
Secretary pursuant to paragraph (1) shall be conducted in a
confidential manner to protect the privacy rights of the individuals
and entities involved in such research, including such individuals
and entities involved in the donation, transfer, receipt, or
transplantation of human fetal tissue. With respect to any material
or information obtained pursuant to such audit, the Secretary
shall--
``(A) use such material or information only for the purposes
of verifying compliance with the requirements of this section;
``(B) not disclose or publish such material or information,
except where required by Federal law, in which case such
material or information shall be coded in a manner such that the
identities of such individuals and entities are protected; and
``(C) not maintain such material or information after
completion of such audit, except where necessary for the
purposes of such audit.
``(e) Applicability of State and Local Law.--
``(1) Research conducted by recipients of assistance.--The
Secretary may not provide support for research under subsection (a)
unless the applicant for the financial assistance involved agrees to
conduct the research in accordance with applicable State law.
``(2) Research conducted by secretary.--The Secretary may
conduct research under subsection (a) only in accordance with
applicable State and local law.
``(f) Report.--The Secretary shall annually submit to the Committee
on Energy and Commerce of the House of Representatives, and to the
Committee on Labor and Human Resources of the Senate, a report
describing the activities carried out under this section during the
preceding fiscal year, including a description of whether and to what
extent research under subsection (a) has been conducted in accordance
with this section.
``(g) Definition.--For purposes of this section, the term `human
fetal tissue' means tissue or cells obtained from a dead human embryo or
fetus after a spontaneous or induced abortion, or after a stillbirth.''.
SEC. 112. PURCHASE OF HUMAN FETAL TISSUE; SOLICITATION OR ACCEPTANCE OF
TISSUE AS DIRECTED DONATION FOR USE IN TRANSPLANTATION.
Part G of title IV of the Public Health Service Act, as amended by
section 111 of this Act, is amended by inserting after section 498A the
following section:
``prohibitions regarding human fetal tissue
``Sec. 498B. (a) Purchase of Tissue.--It shall be unlawful for any
person to knowingly acquire, receive, or otherwise transfer any human
fetal tissue for valuable consideration if the transfer affects
interstate commerce.
``(b) Solicitation or Acceptance of Tissue as Directed Donation for
Use in Transplantation.--It shall be unlawful for any person to solicit
or knowingly acquire, receive, or accept a donation of human fetal
tissue for the purpose of transplantation of such tissue into another
person if the donation affects interstate commerce, the tissue will be
or is obtained pursuant to an induced abortion, and--
``(1) the donation will be or is made pursuant to a promise to
the donating individual that the donated tissue will be transplanted
into a recipient specified by such individual;
``(2) the donated tissue will be transplanted into a relative of
the donating individual; or
``(3) the person who solicits or knowingly acquires, receives,
or accepts the donation has provided valuable consideration for the
costs associated with such abortion.
``(c) Criminal Penalties for Violations.--
``(1) In general.--Any person who violates subsection (a) or (b)
shall be fined in accordance with title 18, United States Code,
subject to paragraph (2), or imprisoned for not more than 10 years,
or both.
``(2) Penalties applicable to persons receiving consideration.--
With respect to the imposition of a fine under paragraph (1), if the
person involved violates subsection (a) or (b)(3), a fine shall be
imposed in an amount not less than twice the amount of the valuable
consideration received.
``(d) Definitions.--For purposes of this section:
``(1) The term `human fetal tissue' has the meaning given such
term in section 498A(f).
``(2) The term `interstate commerce' has the meaning given such
term in section 201(b) of the Federal Food, Drug, and Cosmetic Act.
``(3) The term `valuable consideration' does not include
reasonable payments associated with the transportation,
implantation, processing, preservation, quality control, or storage
of human fetal tissue.''.
SEC. 113. NULLIFICATION OF MORATORIUM.
(a) In General.--Except as provided in subsection (c), no official
of the executive branch may impose a policy that the Department of
Health and Human Services is prohibited from conducting or supporting
any research on the transplantation of human fetal tissue for
therapeutic purposes. Such research shall be carried out in accordance
with section 498A of the Public Health Service Act (as added by section
111 of this Act), without regard to any such policy that may have been
in effect prior to the date of the enactment of this Act.
(b) Prohibition Against Withholding of Funds in Cases of Technical
and Scientific Merit.--
(1) In general.--Subject to subsection (b)(2) of section 492A of
the Public Health Service Act (as added by section 101 of this Act),
in the case of any proposal for research on the transplantation of
human fetal tissue for therapeutic purposes, the Secretary of Health
and Human Services may not withhold funds for the research if--
(A) the research has been approved for purposes of
subsection (a) of such section 492A;
(B) the research will be carried out in accordance with
section 498A of such Act (as added by section 111 of this Act);
and
(C) there are reasonable assurances that the research will
not utilize any human fetal tissue that has been obtained in
violation of section 498B(a) of such Act (as added by section
112 of this Act).
(2) Standing approval regarding ethical status.--In the case of
any proposal for research on the transplantation of human fetal
tissue for therapeutic purposes, the issuance in December 1988 of
the Report of the Human Fetal Tissue Transplantation Research Panel
shall be deemed to be a report--
(A) issued by an ethics advisory board pursuant to section
492A(b)(5)(B)(ii) of the Public Health Service Act (as added by
section 101 of this Act); and
(B) finding, on a basis that is neither arbitrary nor
capricious, that the nature of the research is such that it is
not unethical to conduct or support the research.
(c) Authority for Withholding Funds From Research.--In the case of
any research on the transplantation of human fetal tissue for
therapeutic purposes, the Secretary of Health and Human Services may
withhold funds for the research if any of the conditions specified in
any of subparagraphs (A) through (C) of subsection (b)(1) are not met
with respect to the research.
(d) Definition.--For purposes of this section, the term ``human
fetal tissue'' has the meaning given such term in section 498A(f) of the
Public Health Service Act (as added by section 111 of this Act).
SEC. 114. REPORT BY GENERAL ACCOUNTING OFFICE ON ADEQUACY OF
REQUIREMENTS.
(a) In General.--With respect to research on the transplantation of
human fetal tissue for therapeutic purposes, the Comptroller General of
the United States shall conduct an audit for the purpose of
determining--
(1) whether and to what extent such research conducted or
supported by the Secretary of Health and Human Services has been
conducted in accordance with section 498A of the Public Health
Service Act (as added by section 111 of this Act); and
(2) whether and to what extent there have been violations of
section 498B of such Act (as added by section 112 of this Act).
(b) Report.--Not later than May 19, 1995, the Comptroller General of
the United States shall complete the audit required in subsection (a)
and submit to the Committee on Energy and Commerce of the House of
Representatives, and to the Committee on Labor and Human Resources of
the Senate, a report describing the findings made pursuant to the audit.
PART III--MISCELLANEOUS REPEALS
SEC. 121. REPEALS.
(a) Certain Biomedical Ethics Board.--Title III of the Public Health
Service Act (42 U.S.C. 241 et seq.) is amended by striking part J.
(b) Other Repeals.--Part G of title IV of the Public Health Service
Act (42 U.S.C. 289 et seq.) is amended--
(1) in section 498, by striking subsection (c); and
(2) by striking section 499; and
(3) by redesignating section 499A as section 499.
(c) Nullification of Certain Provisions.--The provisions of
Executive Order 12806 (57 Fed. Reg. 21589 (May 21, 1992)) shall not have
any legal effect. The provisions of section 204(d) of part 46 of title
45 of the Code of Federal Regulations (45 CFR 46.204(d)) shall not have
any legal effect.
Subtitle B--Clinical Research Equity Regarding Women and Minorities
PART I--WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH
SEC. 131. REQUIREMENT OF INCLUSION IN RESEARCH.
Part G of title IV of the Public Health Service Act, as amended by
section 101 of this Act, is amended by inserting after section 492A the
following section:
``inclusion of women and minorities in clinical research
``Sec. 492B. (a) Requirement of Inclusion.--
``(1) In general.--In conducting or supporting clinical research
for purposes of this title, the Director of NIH shall, subject to
subsection (b), ensure that--
``(A) women are included as subjects in each project of such
research; and
``(B) members of minority groups are included as subjects in
such research.
``(2) Outreach regarding participation as subjects.--The
Director of NIH, in consultation with the Director of the Office of
Research on Women's Health and the Director of the Office of
Research on Minority Health, shall conduct or support outreach
programs for the recruitment of women and members of minority groups
as subjects in projects of clinical research.
``(b) Inapplicability of Requirement.--The requirement established
in subsection (a) regarding women and members of minority groups shall
not apply to a project of clinical research if the inclusion, as
subjects in the project, of women and members of minority groups,
respectively--
``(1) is inappropriate with respect to the health of the
subjects;
``(2) is inappropriate with respect to the purpose of the
research; or
``(3) is inappropriate under such other circumstances as the
Director of NIH may designate.
``(c) Design of Clinical Trials.--In the case of any clinical trial
in which women or members of minority groups will under subsection (a)
be included as subjects, the Director of NIH shall ensure that the trial
is designed and carried out in a manner sufficient to provide for a
valid analysis of whether the variables being studied in the trial
affect women or members of minority groups, as the case may be,
differently than other subjects in the trial.
``(d) Guidelines.--
``(1) In general.--Subject to paragraph (2), the Director of
NIH, in consultation with the Director of the Office of Research on
Women's Health and the Director of the Office of Research on
Minority Health, shall establish guidelines regarding the
requirements of this section. The guidelines shall include
guidelines regarding--
``(A) the circumstances under which the inclusion of women
and minorities as subjects in projects of clinical research is
inappropriate for purposes of subsection (b);
``(B) the manner in which clinical trials are required to be
designed and carried out for purposes of subsection (c); and
``(C) the operation of outreach programs under subsection
(a).
``(2) Certain provisions.--With respect to the circumstances
under which the inclusion of women or members of minority groups (as
the case may be) as subjects in a project of clinical research is
inappropriate for purposes of subsection (b), the following applies
to guidelines under paragraph (1):
``(A)(i) In the case of a clinical trial, the guidelines
shall provide that the costs of such inclusion in the trial is
not a permissible consideration in determining whether such
inclusion is inappropriate.
``(ii) In the case of other projects of clinical research,
the guidelines shall provide that the costs of such inclusion in
the project is not a permissible consideration in determining
whether such inclusion is inappropriate unless the data
regarding women or members of minority groups, respectively,
that would be obtained in such project (in the event that such
inclusion were required) have been or are being obtained through
other means that provide data of comparable quality.
``(B) In the case of a clinical trial, the guidelines may
provide that such inclusion in the trial is not required if
there is substantial scientific data demonstrating that there is
no significant difference between--
``(i) the effects that the variables to be studied in
the trial have on women or members of minority groups,
respectively; and
``(ii) the effects that the variables have on the
individuals who would serve as subjects in the trial in the
event that such inclusion were not required.
``(e) Date Certain for Guidelines; Applicability.--
``(1) Date certain.--The guidelines required in subsection (d)
shall be established and published in the Federal Register not later
than 180 days after the date of the enactment of the National
Institutes of Health Revitalization Act of 1993.
``(2) Applicability.--For fiscal year 1995 and subsequent fiscal
years, the Director of NIH may not approve any proposal of clinical
research to be conducted or supported by any agency of the National
Institutes of Health unless the proposal specifies the manner in
which the research will comply with this section.
``(f) Reports by Advisory Councils.--The advisory council of each
national research institute shall prepare biennial reports describing
the manner in which the institute has complied with this section. Each
such report shall be submitted to the Director of the institute involved
for inclusion in the biennial report under section 403.
``(g) Definitions.--For purposes of this section:
``(1) The term `project of clinical research' includes a
clinical trial.
``(2) The term `minority group' includes subpopulations of
minority groups. The Director of NIH shall, through the guidelines
established under subsection (d), define the terms `minority group'
and `subpopulation' for purposes of the preceding sentence.''.
SEC. 132. PEER REVIEW.
Section 492 of the Public Health Service Act (42 U.S.C. 289a) is
amended by adding at the end the following subsection:
``(c)(1) In technical and scientific peer review under this section
of proposals for clinical research, the consideration of any such
proposal (including the initial consideration) shall, except as provided
in paragraph (2), include an evaluation of the technical and scientific
merit of the proposal regarding compliance with section 492B.
``(2) Paragraph (1) shall not apply to any proposal for clinical
research that, pursuant to subsection (b) of section 492B, is not
subject to the requirement of subsection (a) of such section regarding
the inclusion of women and members of minority groups as subjects in
clinical research.''.
SEC. 133. INAPPLICABILITY TO CURRENT PROJECTS.
Section 492B of the Public Health Service Act, as added by section
131 of this Act, shall not apply with respect to projects of clinical
research for which initial funding was provided prior to the date of the
enactment of this Act. With respect to the inclusion of women and
minorities as subjects in clinical research conducted or supported by
the National Institutes of Health, any policies of the Secretary of
Health and Human Services regarding such inclusion that are in effect on
the day before the date of the enactment of this Act shall continue to
apply to the projects referred to in the preceding sentence.
PART II--OFFICE OF RESEARCH ON WOMEN'S HEALTH
SEC. 141. ESTABLISHMENT.
(a) In General.--Title IV of the Public Health Service Act, as
amended by the preceding provisions of this title, is amended--
(1) by redesignating section 486 as section 485A;
(2) by redesignating parts F through H as parts G through I,
respectively; and
(3) by inserting after part E the following part:
``Part F--Research on Women's Health
``SEC. 486. OFFICE OF RESEARCH ON WOMEN'S HEALTH.
``(a) Establishment.--There is established within the Office of the
Director of NIH an office to be known as the Office of Research on
Women's Health (in this part referred to as the `Office'). The Office
shall be headed by a director, who shall be appointed by the Director of
NIH.
``(b) Purpose.--The Director of the Office shall--
``(1) identify projects of research on women's health that
should be conducted or supported by the national research
institutes;
``(2) identify multidisciplinary research relating to research
on women's health that should be so conducted or supported;
``(3) carry out paragraphs (1) and (2) with respect to the aging
process in women, with priority given to menopause;
``(4) promote coordination and collaboration among entities
conducting research identified under any of paragraphs (1) through
(3);
``(5) encourage the conduct of such research by entities
receiving funds from the national research institutes;
``(6) recommend an agenda for conducting and supporting such
research;
``(7) promote the sufficient allocation of the resources of the
national research institutes for conducting and supporting such
research;
``(8) assist in the administration of section 492B with respect
to the inclusion of women as subjects in clinical research; and
``(9) prepare the report required in section 486B.
``(c) Coordinating Committee.--
``(1) In carrying out subsection (b), the Director of the Office
shall establish a committee to be known as the Coordinating
Committee on Research on Women's Health (in this subsection referred
to as the `Coordinating Committee').
``(2) The Coordinating Committee shall be composed of the
Directors of the national research institutes (or the designees of
the Directors).
``(3) The Director of the Office shall serve as the chair of the
Coordinating Committee.
``(4) With respect to research on women's health, the
Coordinating Committee shall assist the Director of the Office in--
``(A) identifying the need for such research, and making an
estimate each fiscal year of the funds needed to adequately
support the research;
``(B) identifying needs regarding the coordination of
research activities, including intramural and extramural
multidisciplinary activities;
``(C) supporting the development of methodologies to
determine the circumstances in which obtaining data specific to
women (including data relating to the age of women and the
membership of women in ethnic or racial groups) is an
appropriate function of clinical trials of treatments and
therapies;
``(D) supporting the development and expansion of clinical
trials of treatments and therapies for which obtaining such data
has been determined to be an appropriate function; and
``(E) encouraging the national research institutes to
conduct and support such research, including such clinical
trials.
``(d) Advisory Committee.--
``(1) In carrying out subsection (b), the Director of the Office
shall establish an advisory committee to be known as the Advisory
Committee on Research on Women's Health (in this subsection referred
to as the `Advisory Committee').
``(2) The Advisory Committee shall be composed of no fewer than
12, and not more than 18 individuals, who are not officers or
employees of the Federal Government. The Director of the Office
shall make appointments to the Advisory Committee from among
physicians, practitioners, scientists, and other health
professionals, whose clinical practice, research specialization, or
professional expertise includes a significant focus on research on
women's health. A majority of the members of the Advisory Committee
shall be women.
``(3) The Director of the Office shall serve as the chair of the
Advisory Committee.
``(4) The Advisory Committee shall--
``(A) advise the Director of the Office on appropriate
research activities to be undertaken by the national research
institutes with respect to--
``(i) research on women's health;
``(ii) research on gender differences in clinical drug
trials, including responses to pharmacological drugs;
``(iii) research on gender differences in disease
etiology, course, and treatment;
``(iv) research on obstetrical and gynecological health
conditions, diseases, and treatments; and
``(v) research on women's health conditions which
require a multidisciplinary approach;
``(B) report to the Director of the Office on such research;
``(C) provide recommendations to such Director regarding
activities of the Office (including recommendations on the
development of the methodologies described in subsection
(c)(4)(C) and recommendations on priorities in carrying out
research described in subparagraph (A)); and
``(D) assist in monitoring compliance with section 492B
regarding the inclusion of women in clinical research.
``(5)(A) The Advisory Committee shall prepare a biennial report
describing the activities of the Committee, including findings made
by the Committee regarding--
``(i) compliance with section 492B;
``(ii) the extent of expenditures made for research on
women's health by the agencies of the National Institutes of
Health; and
``(iii) the level of funding needed for such research.
``(B) The report required in subparagraph (A) shall be submitted
to the Director of NIH for inclusion in the report required in
section 403.
``(e) Representation of Women Among Researchers.--The Secretary,
acting through the Assistant Secretary for Personnel and in
collaboration with the Director of the Office, shall determine the
extent to which women are represented among senior physicians and
scientists of the national research institutes and among physicians and
scientists conducting research with funds provided by such institutes,
and as appropriate, carry out activities to increase the extent of such
representation.
``(f) Definitions.--For purposes of this part:
``(1) The term `women's health conditions', with respect to
women of all age, ethnic, and racial groups, means all diseases,
disorders, and conditions (including with respect to mental
health)--
``(A) unique to, more serious, or more prevalent in women;
``(B) for which the factors of medical risk or types of
medical intervention are different for women, or for which it is
unknown whether such factors or types are different for women;
or
``(C) with respect to which there has been insufficient
clinical research involving women as subjects or insufficient
clinical data on women.
``(2) The term `research on women's health' means research on
women's health conditions, including research on preventing such
conditions.
``SEC. 486A. NATIONAL DATA SYSTEM AND CLEARINGHOUSE ON RESEARCH ON
WOMEN'S HEALTH.
``(a) Data System.--
``(1) The Director of NIH, in consultation with the Director of
the Office and the Director of the National Library of Medicine,
shall establish a data system for the collection, storage, analysis,
retrieval, and dissemination of information regarding research on
women's health that is conducted or supported by the national
research institutes. Information from the data system shall be
available through information systems available to health care
professionals and providers, researchers, and members of the public.
``(2) The data system established under paragraph (1) shall
include a registry of clinical trials of experimental treatments
that have been developed for research on women's health. Such
registry shall include information on subject eligibility criteria,
sex, age, ethnicity or race, and the location of the trial site or
sites. Principal investigators of such clinical trials shall provide
this information to the registry within 30 days after it is
available. Once a trial has been completed, the principal
investigator shall provide the registry with information pertaining
to the results, including potential toxicities or adverse effects
associated with the experimental treatment or treatments evaluated.
``(b) Clearinghouse.--The Director of NIH, in consultation with the
Director of the Office and with the National Library of Medicine, shall
establish, maintain, and operate a program to provide information on
research and prevention activities of the national research institutes
that relate to research on women's health.
``SEC. 486B. BIENNIAL REPORT.
``(a) In General.--With respect to research on women's health, the
Director of the Office shall, not later than February 1, 1994, and
biennially thereafter, prepare a report--
``(1) describing and evaluating the progress made during the
preceding 2 fiscal years in research and treatment conducted or
supported by the National Institutes of Health;
``(2) describing and analyzing the professional status of women
physicians and scientists of such Institutes, including the
identification of problems and barriers regarding advancements;
``(3) summarizing and analyzing expenditures made by the
agencies of such Institutes (and by such Office) during the
preceding 2 fiscal years; and
``(4) making such recommendations for legislative and
administrative initiatives as the Director of the Office determines
to be appropriate.
``(b) Inclusion in Biennial Report of Director of NIH.--The Director
of the Office shall submit each report prepared under subsection (a) to
the Director of NIH for inclusion in the report submitted to the
President and the Congress under section 403.''.
(b) Requirement of Sufficient Allocation of Resources of
Institutes.--Section 402(b) of the Public Health Service Act (42 U.S.C.
282(b)) is amended--
(1) in paragraph (10), by striking ``and'' after the semicolon
at the end;
(2) in paragraph (11), by striking the period at the end and
inserting ``; and''; and
(3) by inserting after paragraph (11) the following paragraph:
``(12) after consultation with the Director of the Office of
Research on Women's Health, shall ensure that resources of the
National Institutes of Health are sufficiently allocated for
projects of research on women's health that are identified under
section 486(b).''.
PART III--OFFICE OF RESEARCH ON MINORITY HEALTH
SEC. 151. ESTABLISHMENT.
Part A of title IV of the Public Health Service Act (42 U.S.C. 281
et seq.) is amended by adding at the end the following section:
``office of research on minority health
``Sec. 404. (a) Establishment.--There is established within the
Office of the Director of NIH an office to be known as the Office of
Research on Minority Health (in this section referred to as the
`Office'). The Office shall be headed by a director, who shall be
appointed by the Director of NIH.
``(b) Purpose.--The Director of the Office shall--
``(1) identify projects of research on minority health that
should be conducted or supported by the national research
institutes;
``(2) identify multidisciplinary research relating to research
on minority health that should be so conducted or supported;
``(3) promote coordination and collaboration among entities
conducting research identified under paragraph (1) or (2);
``(4) encourage the conduct of such research by entities
receiving funds from the national research institutes;
``(5) recommend an agenda for conducting and supporting such
research;
``(6) promote the sufficient allocation of the resources of the
national research institutes for conducting and supporting such
research; and
``(7) assist in the administration of section 492B with respect
to the inclusion of members of minority groups as subjects in
clinical research.''.
Subtitle C--Research Integrity
SEC. 161. ESTABLISHMENT OF OFFICE OF RESEARCH INTEGRITY.
Section 493 of the Public Health Service Act (42 U.S.C. 289b) is
amended to read as follows:
``office of research integrity
``Sec. 493. (a) In General.--
``(1) Establishment of office.--Not later than 90 days after the
date of enactment of this section, the Secretary shall establish an
office to be known as the Office of Research Integrity (referred to
in this section as the `Office'), which shall be established as an
independent entity in the Department of Health and Human Services.
``(2) Appointment of director.--The Office shall be headed by a
Director, who shall be appointed by the Secretary, be experienced
and specially trained in the conduct of research, and have
experience in the conduct of investigations of research misconduct.
The Secretary shall carry out this section acting through the
Director of the Office. The Director shall report to the Secretary.
``(3) Definitions.--
``(A) The Secretary shall by regulation establish a
definition for the term `research misconduct' for purposes of
this section.
``(B) For purposes of this section, the term `financial
assistance' means a grant, contract, or cooperative agreement.
``(b) Existence of Administrative Processes as Condition of Funding
for Research.--The Secretary shall by regulation require that each
entity that applies for financial assistance under this Act for any
project or program that involves the conduct of biomedical or behavioral
research submit in or with its application for such assistance--
``(1) assurances satisfactory to the Secretary that such entity
has established and has in effect (in accordance with regulations
which the Secretary shall prescribe) an administrative process to
review reports of research misconduct in connection with biomedical
and behavioral research conducted at or sponsored by such entity;
``(2) an agreement that the entity will report to the Director
any investigation of alleged research misconduct in connection with
projects for which funds have been made available under this Act
that appears substantial; and
``(3) an agreement that the entity will comply with regulations
issued under this section.
``(c) Process for Response of Director.--The Secretary shall by
regulation establish a process to be followed by the Director for the
prompt and appropriate--
``(1) response to information provided to the Director
respecting research misconduct in connection with projects for which
funds have been made available under this Act;
``(2) receipt of reports by the Director of such information
from recipients of funds under this Act;
``(3) conduct of investigations, when appropriate; and
``(4) taking of other actions, including appropriate remedies,
with respect to such misconduct.
``(d) Monitoring by Director.--The Secretary shall by regulation
establish procedures for the Director to monitor administrative
processes and investigations that have been established or carried out
under this section.''.
SEC. 162. COMMISSION ON RESEARCH INTEGRITY.
(a) In General.--Not later than 90 days after the date of the
enactment of this Act, the Secretary of Health and Human Services shall
establish a commission to be known as the Commission on Research
Integrity (in this section referred to as the ``Commission'').
(b) Duties.--The Commission shall develop recommendations for the
Secretary of Health and Human Services on the administration of section
493 of the Public Health Service Act (as amended and added by section
161 of this Act).
(c) Composition.--The Commission shall be composed of 12 members to
be appointed by the Secretary of Health and Human Services. Not more
than 3 members of the Commission may be officers or employees of the
United States. Of the members of the Commission--
(1) three shall be scientists with substantial accomplishments
in biomedical or behavioral research;
(2) three shall be individuals with experience in investigating
allegations of misconduct with respect to research;
(3) three shall be representatives of institutions of higher
education at which biomedical or behavioral research is conducted;
and
(4) three shall be individuals who are not described in
paragraph (1), (2), or (3), at least one of whom shall be an
attorney and at least one of whom shall be an ethicist.
(d) Compensation.--Members of the Commission may not receive
compensation for service on the Commission. Members may be reimbursed
for travel, subsistence, and other necessary expenses incurred in
carrying out the duties of the Commission.
(e) Report.--Not later than 120 days after the date on which the
Commission is established under subsection (a), the Commission shall
prepare and submit to the Secretary of Health and Human Services, the
Committee on Energy and Commerce of the House of Representatives, and
the Committee on Labor and Human Resources of the Senate, a report
containing the recommendations developed under subsection (b).
SEC. 163. PROTECTION OF WHISTLEBLOWERS.
Section 493 of the Public Health Service Act, as amended by section
161 of this Act, is amended by adding at the end the following
subsection:
``(e) Protection of Whistleblowers.--
``(1) In general.--In the case of any entity required to
establish administrative processes under subsection (b), the
Secretary shall by regulation establish standards for preventing,
and for responding to the occurrence of retaliation by such entity,
its officials or agents, against an employee in the terms and
conditions of employment in response to the employee having in good
faith--
``(A) made an allegation that the entity, its officials or
agents, has engaged in or failed to adequately respond to an
allegation of research misconduct; or
``(B) cooperated with an investigation of such an
allegation.
``(2) Monitoring by secretary.--The Secretary shall by
regulation establish procedures for the Director to monitor the
implementation of the standards established by an entity under
paragraph (1) for the purpose of determining whether the procedures
have been established, and are being utilized, in accordance with
the standards established under such paragraph.
``(3) Noncompliance.--The Secretary shall by regulation
establish remedies for noncompliance by an entity, its officials or
agents, which has engaged in retaliation in violation of the
standards established under paragraph (1). Such remedies may include
termination of funding provided by the Secretary for such project or
recovery of funding being provided by the Secretary for such
project, or other actions as appropriate.''.
SEC. 164. REQUIREMENT OF REGULATIONS REGARDING PROTECTION AGAINST
FINANCIAL CONFLICTS OF INTEREST IN CERTAIN PROJECTS OF
RESEARCH.
Part H of title IV of the Public Health Service Act, as redesignated
by section 141(a)(2) of this Act, is amended by inserting after section
493 the following new section:
``protection against financial conflicts of interest in certain
projects of research
``Sec. 493A. (a) Issuance of Regulations.--The Secretary shall by
regulation define the specific circumstances that constitute the
existence of a financial interest in a project on the part of an entity
or individual that will, or may be reasonably expected to, create a bias
in favor of obtaining results in such project that are consistent with
such financial interest. Such definition shall apply uniformly to each
entity or individual conducting a research project under this Act. In
the case of any entity or individual receiving assistance from the
Secretary for a project of research described in subsection (b), the
Secretary shall by regulation establish standards for responding to,
including managing, reducing, or eliminating, the existence of such a
financial interest. The entity may adopt individualized procedures for
implementing the standards.
``(b) Relevant Projects.--A project of research referred to in
subsection (a) is a project of clinical research whose purpose is to
evaluate the safety or effectiveness of a drug, medical device, or
treatment and for which such entity is receiving assistance from the
Secretary.
``(c) Identifying and Reporting to Secretary.--The Secretary shall
by regulation require that each entity described in subsection (a) that
applies for assistance under this Act for any project described in
subsection (b) submit in or with its application for such assistance--
``(1) assurances satisfactory to the Secretary that such entity
has established and has in effect an administrative process under
subsection (a) to identify financial interests (as defined under
subsection (a)) that exist regarding the project; and
``(2) an agreement that the entity will report to the Secretary
such interests identified by the entity and how any such interests
identified by the entity will be managed or eliminated in order that
the project in question will be protected from bias that may stem
from such interests; and
``(3) an agreement that the entity will comply with regulations
issued under this section.
``(d) Monitoring of Process.--The Secretary shall monitor the
establishment and conduct of the administrative process established by
an entity pursuant to subsection (a).
``(e) Response.--In any case in which the Secretary determines that
an entity has failed to comply with subsection (c) regarding a project
of research described in subsection (b), the Secretary--
``(1) shall require that, as a condition of receiving
assistance, the entity disclose the existence of a financial
interest (as defined under subsection (a)) in each public
presentation of the results of such project; and
``(2) may take such other actions as the Secretary determines to
be appropriate.
``(f) Definitions.--For purposes of this section:
``(1) The term `financial interest' includes the receipt of
consulting fees or honoraria and the ownership of stock or equity.
``(2) The term `assistance', with respect to conducting a
project of research, means a grant, contract, or cooperative
agreement.''.
SEC. 165. REGULATIONS.
(a) Issuance of Final Rules.--
(1) In general.--Not later than 180 days after the date of the
enactment of this Act, the Secretary shall, subject to paragraph
(2), issue the final rule for each regulation required in section
493 or 493A of the Public Health Service Act.
(2) Definition of research misconduct.--Not later than 90 days
after the date on which the report required in section 162(e) is
submitted to the Secretary, the Secretary shall issue the final rule
for the regulations required in section 493 of the Public Health
Service Act with respect to the definition of the term ``research
misconduct''.
(b) Applicability to Ongoing Investigations.--The final rule issued
pursuant to subsection (a) for investigations under section 493 of the
Public Health Service Act does not apply to investigations commenced
before the date of the enactment of this Act under authority of such
section as in effect before such date.
(c) Definitions.--For purposes of this section:
(1) The term ``section 493 of the Public Health Service Act''
means such section as amended by sections 161 and 163 of this Act,
except as indicated otherwise in subsection (b).
(2) The term ``section 493A of the Public Health Service Act''
means such section as added by section 164 of this Act.
(3) The term ``Secretary'' means the Secretary of Health and
Human Services.
TITLE II--NATIONAL INSTITUTES OF HEALTH IN GENERAL
SEC. 201. HEALTH PROMOTION RESEARCH DISSEMINATION.
Section 402(f) of the Public Health Service Act (42 U.S.C. 282(f))
is amended by striking ``other public and private entities.'' and all
that follows through the end and inserting ``other public and private
entities, including elementary, secondary, and post-secondary schools.
The Associate Director shall--
``(1) annually review the efficacy of existing policies and
techniques used by the national research institutes to disseminate
the results of disease prevention and behavioral research programs;
``(2) recommend, coordinate, and oversee the modification or
reconstruction of such policies and techniques to ensure maximum
dissemination, using advanced technologies to the maximum extent
practicable, of research results to such entities; and
``(3) annually prepare and submit to the Director of NIH a
report concerning the prevention and dissemination activities
undertaken by the Associate Director, including--
``(A) a summary of the Associate Director's review of
existing dissemination policies and techniques together with a
detailed statement concerning any modification or restructuring,
or recommendations for modification or restructuring, of such
policies and techniques; and
``(B) a detailed statement of the expenditures made for the
prevention and dissemination activities reported on and the
personnel used in connection with such activities.''.
SEC. 202. PROGRAMS FOR INCREASED SUPPORT REGARDING CERTAIN STATES AND
RESEARCHERS.
Section 402 of the Public Health Service Act (42 U.S.C. 282) is
amended by adding at the end the following subsection:
``(g)(1)(A) In the case of entities described in subparagraph (B),
the Director of NIH, acting through the Director of the National Center
for Research Resources, shall establish a program to enhance the
competitiveness of such entities in obtaining funds from the national
research institutes for conducting biomedical and behavioral research.
``(B) The entities referred to in subparagraph (A) are entities that
conduct biomedical and behavioral research and are located in a State in
which the aggregate success rate for applications to the national
research institutes for assistance for such research by the entities in
the State has historically constituted a low success rate of obtaining
such funds, relative to such aggregate rate for such entities in other
States.
``(C) With respect to enhancing competitiveness for purposes of
subparagraph (A), the Director of NIH, in carrying out the program
established under such subparagraph, may--
``(i) provide technical assistance to the entities involved,
including technical assistance in the preparation of applications
for obtaining funds from the national research institutes;
``(ii) assist the entities in developing a plan for biomedical
or behavioral research proposals; and
``(iii) assist the entities in implementing such plan.
``(2) The Director of NIH shall establish a program of supporting
projects of biomedical or behavioral research whose principal
researchers are individuals who have not previously served as the
principal researchers of such projects supported by the Director.''.
SEC. 203. ESTABLISHMENT OF OFFICE OF BEHAVIORAL AND SOCIAL SCIENCES
RESEARCH.
(a) In General.--Part A of title IV of the Public Health Service
Act, as amended by section 151 of this Act, is amended by adding at the
end the following section:
``office of behavioral and social sciences research
``Sec. 404A. (a) There is established within the Office of the
Director of NIH an office to be known as the Office of Behavioral and
Social Sciences Research (in this section referred to as the `Office').
The Office shall be headed by a director, who shall be appointed by the
Director of NIH.
``(b)(1) With respect to research on the relationship between human
behavior and the development, treatment, and prevention of medical
conditions, the Director of the Office shall--
``(A) coordinate research conducted or supported by the agencies
of the National Institutes of Health; and
``(B) identify projects of behavioral and social sciences
research that should be conducted or supported by the national
research institutes, and develop such projects in cooperation with
such institutes.
``(2) Research authorized under paragraph (1) includes research on
teen pregnancy, infant mortality, violent behavior, suicide, and
homelessness. Such research does not include neurobiological research,
or research in which the behavior of an organism is observed for the
purpose of determining activity at the cellular or molecular level.''.
(b) Report.--Not later than February 1, 1994, the Director of the
Office of Behavioral and Social Sciences Research (established in
section 404A of the Public Health Service Act, as added by subsection
(a) of this section) shall submit to the Committee on Energy and
Commerce of the House of Representatives, and to the Committee on Labor
and Human Resources of the Senate, a report describing the extent to
which the national research institutes of the National Institutes of
Health conduct and support behavioral research and social sciences
research. In preparing the report, such Director shall (subject to
subsection (b)(2) of such section 404A) state the definitions used in
the report for the terms ``behavioral research'' and ``social sciences
research'', and shall apply the definitions uniformly to such institutes
for purposes of the report.
(c) Effective Dates.--The amendment described in subsection (a) is
made upon the date of the enactment of this Act and takes effect July 1,
1993. Subsection (b) takes effect on such date.
SEC. 204. CHILDREN'S VACCINE INITIATIVE.
Part A of title IV of the Public Health Service Act, as amended by
section 203 of this Act, is amended by adding at the end the following
section:
``children's vaccine initiative
``Sec. 404B. (a) Development of New Vaccines.--The Secretary, in
consultation with the Director of the National Vaccine Program under
title XXI and acting through the Directors of the National Institute for
Allergy and Infectious Diseases, the National Institute for Child Health
and Human Development, the National Institute for Aging, and other
public and private programs, shall carry out activities, which shall be
consistent with the global Children's Vaccine Initiative, to develop
affordable new and improved vaccines to be used in the United States and
in the developing world that will increase the efficacy and efficiency
of the prevention of infectious diseases. In carrying out such
activities, the Secretary shall, to the extent practicable, develop and
make available vaccines that require fewer contacts to deliver, that can
be given early in life, that provide long lasting protection, that
obviate refrigeration, needles and syringes, and that protect against a
larger number of diseases.
``(b) Report.--In the report required in section 2104, the
Secretary, acting through the Director of the National Vaccine Program
under title XXI, shall include information with respect to activities
and the progress made in implementing the provisions of this section and
achieving its goals.
``(c) Authorization of Appropriations.--In addition to any other
amounts authorized to be appropriated for activities of the type
described in this section, there are authorized to be appropriated to
carry out this section $20,000,000 for fiscal year 1994, and such sums
as may be necessary for each of the fiscal years 1995 and 1996.''.
SEC. 205. PLAN FOR USE OF ANIMALS IN RESEARCH.
(a) In General.--Part A of title IV of the Public Health Service
Act, as amended by section 204 of this Act, is amended by adding at the
end the following section:
``plan for use of animals in research
``Sec. 404C. (a) The Director of NIH, after consultation with the
committee established under subsection (e), shall prepare a plan--
``(1) for the National Institutes of Health to conduct or
support research into--
``(A) methods of biomedical research and experimentation
that do not require the use of animals;
``(B) methods of such research and experimentation that
reduce the number of animals used in such research;
``(C) methods of such research and experimentation that
produce less pain and distress in such animals; and
``(D) methods of such research and experimentation that
involve the use of marine life (other than marine mammals);
``(2) for establishing the validity and reliability of the
methods described in paragraph (1);
``(3) for encouraging the acceptance by the scientific community
of such methods that have been found to be valid and reliable; and
``(4) for training scientists in the use of such methods that
have been found to be valid and reliable.
``(b) Not later than October 1, 1993, the Director of NIH shall
submit to the Committee on Energy and Commerce of the House of
Representatives, and to the Committee on Labor and Human Resources of
the Senate, the plan required in subsection (a) and shall begin
implementation of the plan.
``(c) The Director of NIH shall periodically review, and as
appropriate, make revisions in the plan required under subsection (a). A
description of any revision made in the plan shall be included in the
first biennial report under section 403 that is submitted after the
revision is made.
``(d) The Director of NIH shall take such actions as may be
appropriate to convey to scientists and others who use animals in
biomedical or behavioral research or experimentation information
respecting the methods found to be valid and reliable under subsection
(a)(2).
``(e)(1) The Director of NIH shall establish within the National
Institutes of Health a committee to be known as the Interagency
Coordinating Committee on the Use of Animals in Research (in this
subsection referred to as the `Committee').
``(2) The Committee shall provide advice to the Director of NIH on
the preparation of the plan required in subsection (a).
``(3) The Committee shall be composed of--
``(A) the Directors of each of the national research institutes
and the Director of the Center for Research Resources (or the
designees of such Directors); and
``(B) representatives of the Environmental Protection Agency,
the Food and Drug Administration, the Consumer Product Safety
Commission, the National Science Foundation, and such additional
agencies as the Director of NIH determines to be appropriate, which
representatives shall include not less than one veterinarian with
expertise in laboratory-animal medicine.''.
(b) Conforming Amendment.--Section 4 of the Health Research
Extension Act of 1985 (Public Law 99-158; 99 Stat. 880) is repealed.
SEC. 206. INCREASED PARTICIPATION OF WOMEN AND DISADVANTAGED INDIVIDUALS
IN FIELDS OF BIOMEDICAL AND BEHAVIORAL RESEARCH.
Section 402 of the Public Health Service Act, as amended by section
202 of this Act, is amended by adding at the end the following
subsection:
``(h) The Secretary, acting through the Director of NIH and the
Directors of the agencies of the National Institutes of Health, shall,
in conducting and supporting programs for research, research training,
recruitment, and other activities, provide for an increase in the number
of women and individuals from disadvantaged backgrounds (including
racial and ethnic minorities) in the fields of biomedical and behavioral
research.''.
SEC. 207. REQUIREMENTS REGARDING SURVEYS OF SEXUAL BEHAVIOR.
Part A of title IV of the Public Health Service Act, as amended by
section 205 of this Act, is amended by adding at the end the following
section:
``requirements regarding surveys of sexual behavior
``Sec. 404D. With respect to any survey of human sexual behavior
proposed to be conducted or supported through the National Institutes of
Health, the survey may not be carried out unless--
``(1) the proposal has undergone review in accordance with any
applicable requirements of sections 491 and 492; and
``(2) the Secretary, in accordance with section 492A, makes a
determination that the information expected to be obtained through
the survey will assist--
``(A) in reducing the incidence of sexually transmitted
diseases, the incidence of infection with the human
immunodeficiency virus, or the incidence of any other infectious
disease; or
``(B) in improving reproductive health or other conditions
of health.''.
SEC. 208. DISCRETIONARY FUND OF DIRECTOR OF NATIONAL INSTITUTES OF
HEALTH.
Section 402 of the Public Health Service Act, as amended by section
206 of this Act, is amended by adding at the end the following
subsection:
``(i)(1) There is established a fund, consisting of amounts
appropriated under paragraph (3) and made available for the fund, for
use by the Director of NIH to carry out the activities authorized in
this Act for the National Institutes of Health. The purposes for which
such fund may be expended include--
``(A) providing for research on matters that have not received
significant funding relative to other matters, responding to new
issues and scientific emergencies, and acting on research
opportunities of high priority;
``(B) supporting research that is not exclusively within the
authority of any single agency of such Institutes; and
``(C) purchasing or renting equipment and quarters for
activities of such Institutes.
``(2) Not later than February 10 of each fiscal year, the Secretary
shall submit to the Committee on Energy and Commerce of the House of
Representatives, and to the Committee on Labor and Human Resources of
the Senate, a report describing the activities undertaken and
expenditures made under this section during the preceding fiscal year.
The report may contain such comments of the Secretary regarding this
section as the Secretary determines to be appropriate.
``(3) For the purpose of carrying out this subsection, there are
authorized to be appropriated $25,000,000 for fiscal year 1994, and such
sums as may be necessary for each of the fiscal years 1995 and 1996.''.
SEC. 209. ESTABLISHMENT OF OFFICE OF ALTERNATIVE MEDICINE.
Part A of title IV of the Public Health Service Act, as amended by
section 207 of this Act, is amended by adding at the end the following
section:
``office of alternative medicine
``Sec. 404E. (a) There is established within the Office of the
Director of NIH an office to be known as the Office of Alternative
Medicine (in this section referred to as the `Office'), which shall be
headed by a director appointed by the Director of NIH.
``(b) The purpose of the Office is to facilitate the evaluation of
alternative medical treatment modalities, including acupuncture and
Oriental medicine, homeopathic medicine, and physical manipulation
therapies.
``(c) The Secretary shall establish an advisory council for the
purpose of providing advice to the Director of the Office on carrying
out this section. Section 222 applies to such council to the same extent
and in the same manner as such section applies to committees or councils
established under such section.
``(d) In carrying out subsection (b), the Director of the Office
shall--
``(1) establish an information clearinghouse to exchange
information with the public about alternative medicine;
``(2) support research training--
``(A) for which fellowship support is not provided under
section 487; and
``(B) that is not residency training of physicians or other
health professionals; and
``(3)(A) prepare biennial reports on the activities carried out
or to be carried out by the Office; and
``(B) submit each such report to the Director of NIH for
inclusion in the biennial report under section 403.''.
SEC. 210. MISCELLANEOUS PROVISIONS.
(a) Term of Office for Members of Advisory Councils.--Section 406(c)
of the Public Health Service Act (42 U.S.C. 284a(c)) is amended in the
second sentence by striking ``until a successor has taken office'' and
inserting the following: ``for 180 days after the date of such
expiration''.
(b) Literacy Requirements.--Section 402(e) of the Public Health
Service Act (42 U.S.C. 282(e)) is amended--
(1) in paragraph (3), by striking ``and'' at the end;
(2) in paragraph (4), by striking the period and inserting ``;
and''; and<!!>
(3) by adding at the end the following paragraph:
``(5) ensure that, after January 1, 1994, all new or revised
health education and promotion materials developed or funded by the
National Institutes of Health and intended for the general public
are in a form that does not exceed a level of functional literacy,
as defined in the National Literacy Act of 1991 (Public Law 102-
73).''.
(c) Day Care Regarding Children of Employees.--Section 402 of the
Public Health Service Act, as amended by section 208 of this Act, is
amended by adding at the end the following subsection:
``(j)(1) The Director of NIH may establish a program to provide day
care services for the employees of the National Institutes of Health
similar to those services provided by other Federal agencies (including
the availability of day care service on a 24-hour-a-day basis).
``(2) Any day care provider at the National Institutes of Health
shall establish a sliding scale of fees that takes into consideration
the income and needs of the employee.
``(3) For purposes regarding the provision of day care services, the
Director of NIH may enter into rental or lease purchase agreements.''.
TITLE III--GENERAL PROVISIONS RESPECTING NATIONAL RESEARCH INSTITUTES
SEC. 301. APPOINTMENT AND AUTHORITY OF DIRECTORS OF NATIONAL RESEARCH
INSTITUTES.
(a) Establishment of General Authority Regarding Direct Funding.--
(1) In general.--Section 405(b)(2) of the Public Health Service
Act (42 U.S.C. 284(b)(2)) is amended--
(A) in subparagraph (A), by striking ``and'' after the
semicolon at the end;
(B) in subparagraph (B), by striking the period at the end
and inserting ``; and''; and
(C) by adding at the end the following subparagraph:
``(C) shall, subject to section 2353(d)(2), receive from the
President and the Office of Management and Budget directly all funds
appropriated by the Congress for obligation and expenditure by the
Institute.''.
(2) Conforming amendment.--Section 413(b)(9) of the Public
Health Service Act (42 U.S.C. 285a-2(b)(9)) is amended--
(A) by striking ``(A)'' after ``(9)''; and
(B) by striking ``advisory council;'' and all that follows
and inserting ``advisory council.''.
(b) Appointment and Duration of Technical and Scientific Peer Review
Groups.--Section 405(c) of the Public Health Service Act (42 U.S.C.
284(c)) is amended--
(1) by amending paragraph (3) to read as follows:
``(3) may, in consultation with the advisory council for the
Institute and with the approval of the Director of NIH--
``(A) establish technical and scientific peer review groups
in addition to those appointed under section 402(b)(6); and
``(B) appoint the members of peer review groups established
under subparagraph (A); and''; and
(2) by adding after and below paragraph (4) the following:
``The Federal Advisory Committee Act shall not apply to the duration of
a peer review group appointed under paragraph (3).''.
SEC. 302. PROGRAM OF RESEARCH ON OSTEOPOROSIS, PAGET'S DISEASE, AND
RELATED BONE DISORDERS.
Part B of title IV of the Public Health Service Act (42 U.S.C. 284
et seq.), as amended by section 121(b) of Public Law 102-321 (106 Stat.
358), is amended by adding at the end the following section:
``research on osteoporosis, paget's disease, and related bone
disorders
``Sec. 409A. (a) Establishment.--The Directors of the National
Institute of Arthritis and Musculoskeletal and Skin Diseases, the
National Institute on Aging, the National Institute of Dental Research,
and the National Institute of Diabetes and Digestive and Kidney
Diseases, shall expand and intensify the programs of such Institutes
with respect to research and related activities concerning osteoporosis,
Paget's disease, and related bone disorders.
``(b) Coordination.--The Directors referred to in subsection (a)
shall jointly coordinate the programs referred to in such subsection and
consult with the Arthritis and Musculoskeletal Diseases Interagency
Coordinating Committee and the Interagency Task Force on Aging Research.
``(c) Information Clearinghouse.--
``(1) In general.--In order to assist in carrying out the
purpose described in subsection (a), the Director of NIH shall
provide for the establishment of an information clearinghouse on
osteoporosis and related bone disorders to facilitate and enhance
knowledge and understanding on the part of health professionals,
patients, and the public through the effective dissemination of
information.
``(2) Establishment through grant or contract.--For the purpose
of carrying out paragraph (1), the Director of NIH shall enter into
a grant, cooperative agreement, or contract with a nonprofit private
entity involved in activities regarding the prevention and control
of osteoporosis and related bone disorders.
``(d) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated $40,000,000
for fiscal year 1994, and such sums as may be necessary for each of the
fiscal years 1995 and 1996.''.
SEC. 303. ESTABLISHMENT OF INTERAGENCY PROGRAM FOR TRAUMA RESEARCH.
(a) In General.--Title XII of the Public Health Service Act (42
U.S.C. 300d et seq.), as amended by title VI of Public Law 102-321 (106
Stat. 433) and section 304 of Public Law 102-408 (106 Stat. 2084), is
amended by adding at the end the following part:
``Part F--Interagency Program for Trauma Research
``SEC. 1261. ESTABLISHMENT OF PROGRAM.
``(a) In General.--The Secretary, acting through the Director of the
National Institutes of Health (in this section referred to as the
`Director'), shall establish a comprehensive program of conducting basic
and clinical research on trauma (in this section referred to as the
`Program'). The Program shall include research regarding the diagnosis,
treatment, rehabilitation, and general management of trauma.
``(b) Plan for Program.--
``(1) In general.--The Director, in consultation with the Trauma
Research Interagency Coordinating Committee established under
subsection (g), shall establish and implement a plan for carrying
out the activities of the Program, including the activities
described in subsection (d). All such activities shall be carried
out in accordance with the plan. The plan shall be periodically
reviewed, and revised as appropriate.
``(2) Submission to congress.--Not later than December 1, 1993,
the Director shall submit the plan required in paragraph (1) to the
Committee on Energy and Commerce of the House of Representatives,
and to the Committee on Labor and Human Resources of the Senate,
together with an estimate of the funds needed for each of the fiscal
years 1994 through 1996 to implement the plan.
``(c) Participating Agencies; Coordination and Collaboration.--The
Director--
``(1) shall provide for the conduct of activities under the
Program by the Directors of the agencies of the National Institutes
of Health involved in research with respect to trauma;
``(2) shall ensure that the activities of the Program are
coordinated among such agencies; and
``(3) shall, as appropriate, provide for collaboration among
such agencies in carrying out such activities.
``(d) Certain Activities of Program.--The Program shall include--
``(1) studies with respect to all phases of trauma care,
including prehospital, resuscitation, surgical intervention,
critical care, infection control, wound healing, nutritional care
and support, and medical rehabilitation care;
``(2) basic and clinical research regarding the response of the
body to trauma and the acute treatment and medical rehabilitation of
individuals who are the victims of trauma; and
``(3) basic and clinical research regarding trauma care for
pediatric and geriatric patients.
``(e) Mechanisms of Support.--In carrying out the Program, the
Director, acting through the Directors of the agencies referred to in
subsection (c)(1), may make grants to public and nonprofit entities,
including designated trauma centers.
``(f) Resources.--The Director shall assure the availability of
appropriate resources to carry out the Program, including the plan
established under subsection (b) (including the activities described in
subsection (d)).
``(g) Coordinating Committee.--
``(1) In general.--There shall be established a Trauma Research
Interagency Coordinating Committee (in this section referred to as
the `Coordinating Committee').
``(2) Duties.--The Coordinating Committee shall make
recommendations regarding--
``(A) the activities of the Program to be carried out by
each of the agencies represented on the Committee and the amount
of funds needed by each of the agencies for such activities; and
``(B) effective collaboration among the agencies in carrying
out the activities.
``(3) Composition.--The Coordinating Committee shall be composed
of the Directors of each of the agencies that, under subsection (c),
have responsibilities under the Program, and any other individuals
who are practitioners in the trauma field as designated by the
Director of the National Institutes of Health.
``(h) Definitions.--For purposes of this section:
``(1) The term `designated trauma center' has the meaning given
such term in section 1231(1).
``(2) The term `Director' means the Director of the National
Institutes of Health.
``(3) The term `trauma' means any serious injury that could
result in loss of life or in significant disability and that would
meet pre-hospital triage criteria for transport to a designated
trauma center.''.
(b) Conforming Amendment.--Section 402 of the Public Health Service
Act, as amended by section 210(c) of this Act, is amended by adding at
the end the following subsection:
``(k) The Director of NIH shall carry out the program established in
part F of title XII (relating to interagency research on trauma).''.
TITLE IV--NATIONAL CANCER INSTITUTE
SEC. 401. EXPANSION AND INTENSIFICATION OF ACTIVITIES REGARDING BREAST
CANCER.
Subpart 1 of part C of title IV of the Public Health Service Act (42
U.S.C. 285 et seq.) is amended by adding at the end the following
section:
``breast and gynecological cancers
``Sec. 417. (a) Expansion and Coordination of Activities.--The
Director of the Institute, in consultation with the National Cancer
Advisory Board, shall expand, intensify, and coordinate the activities
of the Institute with respect to research on breast cancer, ovarian
cancer, and other cancers of the reproductive system of women.
``(b) Coordination With Other Institutes.--The Director of the
Institute shall coordinate the activities of the Director under
subsection (a) with similar activities conducted by other national
research institutes and agencies of the National Institutes of Health to
the extent that such Institutes and agencies have responsibilities that
are related to breast cancer and other cancers of the reproductive
system of women.
``(c) Programs for Breast Cancer.--
``(1) In general.--In carrying out subsection (a), the Director
of the Institute shall conduct or support research to expand the
understanding of the cause of, and to find a cure for, breast
cancer. Activities under such subsection shall provide for an
expansion and intensification of the conduct and support of--
``(A) basic research concerning the etiology and causes of
breast cancer;
``(B) clinical research and related activities concerning
the causes, prevention, detection and treatment of breast
cancer;
``(C) control programs with respect to breast cancer in
accordance with section 412, including community-based programs
designed to assist women who are members of medically
underserved populations, low-income populations, or minority
groups;
``(D) information and education programs with respect to
breast cancer in accordance with section 413; and
``(E) research and demonstration centers with respect to
breast cancer in accordance with section 414, including the
development and operation of centers for breast cancer research
to bring together basic and clinical, biomedical and behavioral
scientists to conduct basic, clinical, epidemiological,
psychosocial, prevention and treatment research and related
activities on breast cancer.
Not less than six centers shall be operated under subparagraph (E).
Activities of such centers should include supporting new and
innovative research and training programs for new researchers. Such
centers shall give priority to expediting the transfer of research
advances to clinical applications.
``(2) Implementation of plan for programs.--
``(A) The Director of the Institute shall ensure that the
research programs described in paragraph (1) are implemented in
accordance with a plan for the programs. Such plan shall include
comments and recommendations that the Director of the Institute
considers appropriate, with due consideration provided to the
professional judgment needs of the Institute as expressed in the
annual budget estimate prepared in accordance with section
413(9). The Director of the Institute, in consultation with the
National Cancer Advisory Board, shall periodically review and
revise such plan.
``(B) Not later than October 1, 1993, the Director of the
Institute shall submit a copy of the plan to the President's
Cancer Panel, the Secretary and the Director of NIH.
``(C) The Director of the Institute shall submit any
revisions of the plan to the President's Cancer Panel, the
Secretary, and the Director of NIH.
``(D) The Secretary shall provide a copy of the plan
submitted under subparagraph (A), and any revisions submitted
under subparagraph (C), to the Committee on Energy and Commerce
of the House of Representatives and the Committee on Labor and
Human Resources of the Senate.
``(d) Other Cancers.--In carrying out subsection (a), the Director
of the Institute shall conduct or support research on ovarian cancer and
other cancers of the reproductive system of women. Activities under such
subsection shall provide for the conduct and support of--
``(1) basic research concerning the etiology and causes of
ovarian cancer and other cancers of the reproductive system of
women;
``(2) clinical research and related activities into the causes,
prevention, detection and treatment of ovarian cancer and other
cancers of the reproductive system of women;
``(3) control programs with respect to ovarian cancer and other
cancers of the reproductive system of women in accordance with
section 412;
``(4) information and education programs with respect to ovarian
cancer and other cancers of the reproductive system of women in
accordance with section 413; and
``(5) research and demonstration centers with respect to ovarian
cancer and cancers of the reproductive system in accordance with
section 414.
``(e) Report.--The Director of the Institute shall prepare, for
inclusion in the biennial report submitted under section 407, a report
that describes the activities of the National Cancer Institute under the
research programs referred to in subsection (a), that shall include--
``(1) a description of the research plan with respect to breast
cancer prepared under subsection (c);
``(2) an assessment of the development, revision, and
implementation of such plan;
``(3) a description and evaluation of the progress made, during
the period for which such report is prepared, in the research
programs on breast cancer and cancers of the reproductive system of
women;
``(4) a summary and analysis of expenditures made, during the
period for which such report is made, for activities with respect to
breast cancer and cancers of the reproductive system of women
conducted and supported by the National Institutes of Health; and
``(5) such comments and recommendations as the Director
considers appropriate.''.
SEC. 402. EXPANSION AND INTENSIFICATION OF ACTIVITIES REGARDING PROSTATE
CANCER.
Subpart 1 of part C of title IV of the Public Health Service Act, as
amended by section 401 of this Act, is amended by adding at the end the
following section:
``prostate cancer
``Sec. 417A. (a) Expansion and Coordination of Activities.--The
Director of the Institute, in consultation with the National Cancer
Advisory Board, shall expand, intensify, and coordinate the activities
of the Institute with respect to research on prostate cancer.
``(b) Coordination With Other Institutes.--The Director of the
Institute shall coordinate the activities of the Director under
subsection (a) with similar activities conducted by other national
research institutes and agencies of the National Institutes of Health to
the extent that such Institutes and agencies have responsibilities that
are related to prostate cancer.
``(c) Programs.--
``(1) In general.--In carrying out subsection (a), the Director
of the Institute shall conduct or support research to expand the
understanding of the cause of, and to find a cure for, prostate
cancer. Activities under such subsection shall provide for an
expansion and intensification of the conduct and support of--
``(A) basic research concerning the etiology and causes of
prostate cancer;
``(B) clinical research and related activities concerning
the causes, prevention, detection and treatment of prostate
cancer;
``(C) prevention and control and early detection programs
with respect to prostate cancer in accordance with section 412,
particularly as it relates to intensifying research on the role
of prostate specific antigen for the screening and early
detection of prostate cancer;
``(D) an Inter-Institute Task Force, under the direction of
the Director of the Institute, to provide coordination between
relevant National Institutes of Health components of research
efforts on prostate cancer;
``(E) control programs with respect to prostate cancer in
accordance with section 412;
``(F) information and education programs with respect to
prostate cancer in accordance with section 413; and
``(G) research and demonstration centers with respect to
prostate cancer in accordance with section 414, including the
development and operation of centers for prostate cancer
research to bring together basic and clinical, biomedical and
behavioral scientists to conduct basic, clinical,
epidemiological, psychosocial, prevention and control,
treatment, research, and related activities on prostate cancer.
Not less than six centers shall be operated under subparagraph (G).
Activities of such centers should include supporting new and
innovative research and training programs for new researchers. Such
centers shall give priority to expediting the transfer of research
advances to clinical applications.
``(2) Implementation of plan for programs.--
``(A) The Director of the Institute shall ensure that the
research programs described in paragraph (1) are implemented in
accordance with a plan for the programs. Such plan shall include
comments and recommendations that the Director of the Institute
considers appropriate, with due consideration provided to the
professional judgment needs of the Institute as expressed in the
annual budget estimate prepared in accordance with section
413(9). The Director of the Institute, in consultation with the
National Cancer Advisory Board, shall periodically review and
revise such plan.
``(B) Not later than October 1, 1993, the Director of the
Institute shall submit a copy of the plan to the President's
Cancer Panel, the Secretary, and the Director of NIH.
``(C) The Director of the Institute shall submit any
revisions of the plan to the President's Cancer Panel, the
Secretary, and the Director of NIH.
``(D) The Secretary shall provide a copy of the plan
submitted under subparagraph (A), and any revisions submitted
under subparagraph (C), to the Committee on Energy and Commerce
of the House of Representatives and the Committee on Labor and
Human Resources of the Senate.''.
SEC. 403. AUTHORIZATION OF APPROPRIATIONS.
(a) In General.--Subpart 1 of part C of title IV of the Public
Health Service Act, as amended by section 402 of this Act, is amended by
adding at the end the following section:
``authorization of appropriations
``Sec. 417B. (a) Activities Generally.--For the purpose of carrying
out this subpart, there are authorized to be appropriated $2,728,000,000
for fiscal year 1994, and such sums as may be necessary for each of the
fiscal years 1995 and 1996.
``(b) Breast Cancer and Gynecological Cancers.--
``(1) Breast cancer.--
``(A) For the purpose of carrying out subparagraph (A) of
section 417(c)(1), there are authorized to be appropriated
$225,000,000 for fiscal year 1994, and such sums as may be
necessary for each of the fiscal years 1995 and 1996. Such
authorizations of appropriations are in addition to the
authorizations of appropriations established in subsection (a)
with respect to such purpose.
``(B) For the purpose of carrying out subparagraphs (B)
through (E) of section 417(c)(1), there are authorized to be
appropriated $100,000,000 for fiscal year 1994, and such sums as
may be necessary for each of the fiscal years 1995 and 1996.
Such authorizations of appropriations are in addition to the
authorizations of appropriations established in subsection (a)
with respect to such purpose.
``(2) Other cancers.--For the purpose of carrying out subsection
(d) of section 417, there are authorized to be appropriated
$75,000,000 for fiscal year 1994, and such sums as are necessary for
each of the fiscal years 1995 and 1996. Such authorizations of
appropriations are in addition to the authorizations of
appropriations established in subsection (a) with respect to such
purpose.
``(c) Prostate Cancer.--For the purpose of carrying out section
417A, there are authorized to be appropriated $72,000,000 for fiscal
year 1994, and such sums as may be necessary for each of the fiscal
years 1995 and 1996. Such authorizations of appropriations are in
addition to the authorizations of appropriations established in
subsection (a) with respect to such purpose.
``(d) Allocation Regarding Cancer Control.--
``(1) In general.--Of the amounts appropriated for the National
Cancer Institute for a fiscal year, the Director of the Institute
shall make available not less than the applicable percentage
specified in paragraph (2) for carrying out the cancer control
activities authorized in section 412 and for which budget estimates
are made under section 413(b)(9) for the fiscal year.
``(2) Applicable percentage.--The percentage referred to in
paragraph (1) is--
``(A) 7 percent, in the case of fiscal year 1994;
``(B) 9 percent, in the case of fiscal year 1995; and
``(C) 10 percent, in the case of fiscal year 1996 and each
subsequent fiscal year.''.
(b) Conforming Amendments.--
(1) In general.--Section 408 of the Public Health Service Act
(42 U.S.C. 284c) is amended--
(A) by striking subsection (a);
(B) by redesignating subsection (b) as subsection (a);
(C) by redesignating paragraph (5) of subsection (a) (as so
redesignated) as subsection (b); and
(D) by amending the heading for the section to read as
follows:
``certain uses of funds''.
(2) Cross-reference.--Section 464F of the Public Health Service
Act (42 U.S.C. 285m-6) is amended by striking ``section 408(b)(1)''
and inserting ``section 408(a)(1)''.
TITLE V--NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
SEC. 501. EDUCATION AND TRAINING.
Section 421(b) of the Public Health Service Act (42 U.S.C. 285b-
3(b)) is amended--
(1) in paragraph (3), by striking ``and'' after the semicolon at
the end;
(2) in paragraph (4), by striking the period at the end and
inserting ``; and''; and
(3) by inserting after paragraph (4) the following paragraph:
``(5) shall, in consultation with the advisory council for the
Institute, conduct appropriate intramural training and education
programs, including continuing education and laboratory and clinical
research training programs.''.
SEC. 502. CENTERS FOR THE STUDY OF PEDIATRIC CARDIOVASCULAR DISEASES.
Section 422(a)(1) of the Public Health Service Act (42 U.S.C. 285b-
4(a)(1)) is amended--
(1) in subparagraph (B), by striking ``and'' at the end;
(2) in subparagraph (C), by striking the period and inserting
``; and''; and
(3) by adding at the end the following subparagraph:
``(D) three centers for basic and clinical research into,
training in, and demonstration of, advanced diagnostic, prevention,
and treatment (including genetic studies, intrauterine environment
studies, postnatal studies, heart arrhythmias, and acquired heart
disease and preventive cardiology) for cardiovascular diseases in
children.''.
SEC. 503. NATIONAL CENTER ON SLEEP DISORDERS RESEARCH.
Subpart 2 of part C of title IV of the Public Health Service Act (42
U.S.C. 285b et seq.) is amended by adding at the end the following
section:
``national center on sleep disorders research
``Sec. 424. (a) Not later than 1 year after the date of the
enactment of the National Institutes of Health Revitalization Act of
1993, the Director of the Institute shall establish the National Center
on Sleep Disorders Research (in this section referred to as the
`Center'). The Center shall be headed by a director, who shall be
appointed by the Director of the Institute.
``(b) The general purpose of the Center is--
``(1) the conduct and support of research, training, health
information dissemination, and other activities with respect to
sleep disorders, including biological and circadian rhythm research,
basic understanding of sleep, chronobiological and other sleep
related research; and
``(2) to coordinate the activities of the Center with similar
activities of other Federal agencies, including the other agencies
of the National Institutes of Health, and similar activities of
other public entities and nonprofit entities.
``(c)(1) The Director of the National Institutes of Health shall
establish a board to be known as the Sleep Disorders Research Advisory
Board (in this section referred to as the `Advisory Board').
``(2) The Advisory Board shall advise, assist, consult with, and
make recommendations to the Director of the National Institutes of
Health, through the Director of the Institute, and the Director of the
Center concerning matters relating to the scientific activities carried
out by and through the Center and the policies respecting such
activities, including recommendations with respect to the plan required
in subsection (c).
``(3)(A) The Director of the National Institutes of Health shall
appoint to the Advisory Board 12 appropriately qualified representatives
of the public who are not officers or employees of the Federal
Government. Of such members, eight shall be representatives of health
and scientific disciplines with respect to sleep disorders and four
shall be individuals representing the interests of individuals with or
undergoing treatment for sleep disorders.
``(B) The following officials shall serve as ex officio members of
the Advisory Board:
``(i) The Director of the National Institutes of Health.
``(ii) The Director of the Center.
``(iii) The Director of the National Heart, Lung and Blood
Institute.
``(iv) The Director of the National Institute of Mental Health.
``(v) The Director of the National Institute on Aging.
``(vi) The Director of the National Institute of Child Health
and Human Development.
``(vii) The Director of the National Institute of Neurological
Disorders and Stroke.
``(viii) The Assistant Secretary for Health.
``(ix) The Assistant Secretary of Defense (Health Affairs).
``(x) The Chief Medical Director of the Veterans'
Administration.
``(4) The members of the Advisory Board shall, from among the
members of the Advisory Board, designate an individual to serve as the
chair of the Advisory Board.
``(5) Except as inconsistent with, or inapplicable to, this section,
the provisions of section 406 shall apply to the advisory board
established under this section in the same manner as such provisions
apply to any advisory council established under such section.
``(d)(1) After consultation with the Director of the Center and the
advisory board established under subsection (c), the Director of the
National Institutes of Health shall develop a comprehensive plan for the
conduct and support of sleep disorders research.
``(2) The plan developed under paragraph (1) shall identify
priorities with respect to such research and shall provide for the
coordination of such research conducted or supported by the agencies of
the National Institutes of Health.
``(3) The Director of the National Institutes of Health (after
consultation with the Director of the Center and the advisory board
established under subsection (c)) shall revise the plan developed under
paragraph (1) as appropriate.
``(e) The Director of the Center, in cooperation with the Centers
for Disease Control and Prevention, is authorized to coordinate
activities with the Department of Transportation, the Department of
Defense, the Department of Education, the Department of Labor, and the
Department of Commerce to collect data, conduct studies, and disseminate
public information concerning the impact of sleep disorders and sleep
deprivation.''.
SEC. 504. AUTHORIZATION OF APPROPRIATIONS.
Subpart 2 of part C of title IV of the Public Health Service Act, as
amended by section 503 of this Act, is amended by adding at the end the
following section:
``authorization of appropriations
``Sec. 425. For the purpose of carrying out this subpart, there are
authorized to be appropriated $1,500,000,000 for fiscal year 1994, and
such sums as may be necessary for each of the fiscal years 1995 and
1996.''.
SEC. 505. PREVENTION AND CONTROL PROGRAMS.
Section 419 of the Public Health Service Act (42 U.S.C. 285b-1) is
amended by striking ``The Director of the Institute'' and all that
follows and inserting the following: ``(a) The Director of the Institute
shall conduct and support programs for the prevention and control of
heart, blood vessel, lung, and blood diseases. Such programs shall
include community-based and population-based programs carried out in
cooperation with other Federal agencies, with public health agencies of
State or local governments, with nonprofit private entities that are
community-based health agencies, or with other appropriate public or
nonprofit private entities.
``(b) In carrying out programs under subsection (a), the Director of
the Institute shall give special consideration to the prevention and
control of heart, blood vessel, lung, and blood diseases in children,
and in populations that are at increased risk with respect to such
diseases.''.
TITLE VI--NATIONAL INSTITUTE ON DIABETES AND DIGESTIVE AND KIDNEY
DISEASES
SEC. 601. PROVISIONS REGARDING NUTRITIONAL DISORDERS.
Subpart 3 of part C of title IV of the Public Health Service Act (42
U.S.C. 285c et seq.) is amended by adding at the end the following
section:
``nutritional disorders program
``Sec. 434. (a) The Director of the Institute, in consultation with
the Director of NIH, shall establish a program of conducting and
supporting research, training, health information dissemination, and
other activities with respect to nutritional disorders, including
obesity.
``(b) In carrying out the program established under subsection (a),
the Director of the Institute shall conduct and support each of the
activities described in such subsection.
``(c) In carrying out the program established under subsection (a),
the Director of the Institute shall carry out activities to facilitate
and enhance knowledge and understanding of nutritional disorders,
including obesity, on the part of health professionals, patients, and
the public through the effective dissemination of information.''.
(b) Development and Expansion of Research and Training Centers.--
Section 431 of the Public Health Service Act (42 U.S.C. 285c-5) is
amended--
(1) by redesignating subsection (d) as subsection (e); and
(2) by inserting after subsection (c) the following subsection:
``(d)(1) The Director of the Institute shall, subject to the extent
of amounts made available in appropriations Acts, provide for the
development or substantial expansion of centers for research and
training regarding nutritional disorders, including obesity.
``(2) The Director of the Institute shall carry out paragraph (1) in
collaboration with the Director of the National Cancer Institute and
with the Directors of such other agencies of the National Institutes of
Health as the Director of NIH determines to be appropriate.
``(3) Each center developed or expanded under paragraph (1) shall--
``(A) utilize the facilities of a single institution, or be
formed from a consortium of cooperating institutions, meeting such
research and training qualifications as may be prescribed by the
Director;
``(B) conduct basic and clinical research into the cause,
diagnosis, early detection, prevention, control and treatment of
nutritional disorders, including obesity and the impact of nutrition
and diet on child development;
``(C) conduct training programs for physicians and allied health
professionals in current methods of diagnosis and treatment of such
diseases and complications, and in research in such disorders; and
``(D) conduct information programs for physicians and allied
health professionals who provide primary care for patients with such
disorders or complications.''.
TITLE VII--NATIONAL INSTITUTE ON ARTHRITIS AND MUSCULOSKELETAL AND SKIN
DISEASES
SEC. 701. JUVENILE ARTHRITIS.
(a) Purpose.--Section 435 of the Public Health Service Act (42
U.S.C. 285d) is amended by striking ``and other programs'' and all that
follows and inserting the following: ``and other programs with respect
to arthritis and musculoskeletal and skin diseases (including sports-
related disorders), with particular attention to the effect of these
diseases on children.''.
(b) Programs.--Section 436 (42 U.S.C. 285d-1) is amended--
(1) in subsection (a), by inserting after the second sentence,
the following: ``The plan shall place particular emphasis upon
expanding research into better understanding the causes and the
development of effective treatments for arthritis affecting
children.''; and
(2) in subsection (b)--
(A) by striking ``and'' at the end of paragraph (3);
(B) by striking the period at the end of paragraph (4) and
inserting ``; and''; and
(C) by adding at the end the following paragraph:
``(5) research into the causes of arthritis affecting children
and the development, trial, and evaluation of techniques, drugs and
devices used in the diagnosis, treatment (including medical
rehabilitation), and prevention of arthritis in children.''.
(c) Centers.--Section 441 of the Public Health Service Act (42
U.S.C. 286d-6) is amended by adding at the end the following subsection:
``(f) Not later than October 1, 1993, the Director shall establish a
multipurpose arthritis and musculoskeletal disease center for the
purpose of expanding the level of research into the cause, diagnosis,
early detection, prevention, control, and treatment of, and
rehabilitation of children with arthritis and musculoskeletal
diseases.''.
(d) Advisory Board.--
(1) Title.--Section 442(a) of the Public Health Service Act (42
U.S.C. 285d-7(a)) is amended by inserting after ``Arthritis'' the
following: ``and Musculoskeletal and Skin Diseases''.
(2) Composition.--Section 442(b) of the Public Health Service
Act (42 U.S.C. 285d-7(b)) is amended--
(A) in the matter preceding paragraph (1), by striking
``eighteen'' and inserting ``twenty''; and
(B) in paragraph (1)(B)--
(i) by striking ``six'' and inserting ``eight''; and
(ii) by striking ``including'' and all that follows and
inserting the following: ``including one member who is a
person who has such a disease, one person who is the parent
of an adult with such a disease, and two members who are
parents of children with arthritis.''.
(3) Annual report.--Section 442(j) of the Public Health Service
Act (42 U.S.C. 285d-7(j)) is amended--
(1) by striking ``and'' at the end of paragraph (3);
(2) by striking the period at the end of paragraph (4) and
inserting ``; and''; and
(3) by adding at the end the following paragraph:
``(5) contains recommendations for expanding the Institute's
funding of research directly applicable to the cause, diagnosis,
early detection, prevention, control, and treatment of, and
rehabilitation of children with arthritis and musculoskeletal
diseases.''.
TITLE VIII--NATIONAL INSTITUTE ON AGING
SEC. 801. ALZHEIMER'S DISEASE REGISTRY.
(a) In General.--Section 12 of Public Law 99-158 (99 Stat. 885) is--
(1) transferred to subpart 5 of part C of title IV of the Public
Health Service Act (42 U.S.C. 285e et seq.);
(2) redesignated as section 445G; and
(3) inserted after section 445F of such Act.
(b) Technical and Conforming Amendments.--Section 445G of the Public
Health Service Act, as transferred and inserted by subsection (a) of
this section, is amended--
(1) by striking the section heading and all that follows through
``may make a grant'' in subsection (a) and inserting the following:
``alzheimer's disease registry
``Sec. 445G. (a) In General.--The Director of the Institute may make
a grant''; and
(2) by striking subsection (c).
SEC. 802. AGING PROCESSES REGARDING WOMEN.
Subpart 5 of part C of title IV of the Public Health Service Act, as
amended by section 801 of this Act, is amended by adding at the end the
following section:
``aging processes regarding women
``Sec. 445H. The Director of the Institute, in addition to other
special functions specified in section 444 and in cooperation with the
Directors of the other national research institutes and agencies of the
National Institutes of Health, shall conduct research into the aging
processes of women, with particular emphasis given to the effects of
menopause and the physiological and behavioral changes occurring during
the transition from pre- to post-menopause, and into the diagnosis,
disorders, and complications related to aging and loss of ovarian
hormones in women.''.
SEC. 803. AUTHORIZATION OF APPROPRIATIONS.
Subpart 5 of part C of title IV of the Public Health Service Act, as
amended by section 802 of this Act, is amended by adding at the end the
following section:
``authorization of appropriations
``Sec. 445I. For the purpose of carrying out this subpart, there are
authorized to be appropriated $500,000,000 for fiscal year 1994, and
such sums as may be necessary for each of the fiscal years 1995 and
1996.''.
SEC. 804. CONFORMING AMENDMENT.
Section 445C of the Public Health Service Act (42 U.S.C. 285e-5), as
amended by section 9 of Public Law 102-507 (106 Stat. 3287), is
amended--
(1) in subsection (b)(1), in the first sentence, by inserting
after ``Council'' the following: ``on Alzheimer's Disease (in this
section referred to as the `Council')''; and
(2) by adding at the end the following subsection:
``(e) For purposes of this section, the term `Council on Alzheimer's
Disease' means the council established in section 911(a) of Public Law
99-660.''.
TITLE IX--NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
SEC. 901. TROPICAL DISEASES.
Section 446 of the Public Health Service Act (42 U.S.C. 285f) is
amended by inserting before the period the following: ``, including
tropical diseases''.
SEC. 902. CHRONIC FATIGUE SYNDROME.
(a) Research Centers.--Subpart 6 of part C of title IV of the Public
Health Service Act (42 U.S.C. 285f) is amended by adding at the end the
following section:
``research centers regarding chronic fatigue syndrome
``Sec. 447. (a) The Director of the Institute, after consultation
with the advisory council for the Institute, may make grants to, or
enter into contracts with, public or nonprofit private entities for the
development and operation of centers to conduct basic and clinical
research on chronic fatigue syndrome.
``(b) Each center assisted under this section shall use the
facilities of a single institution, or be formed from a consortium of
cooperating institutions, meeting such requirements as may be prescribed
by the Director of the Institute.''.
(b) Extramural Study Section.--Not later than 6 months after the
date of enactment of this Act, the Secretary of Health and Human
Services shall establish an extramural study section for chronic fatigue
syndrome research.
(c) Representatives.--The Secretary of Health and Human Services,
acting through the Director of the National Institutes of Health, shall
ensure that appropriate individuals with expertise in chronic fatigue
syndrome or neuromuscular diseases and representative of a variety of
disciplines and fields within the research community are appointed to
appropriate National Institutes of Health advisory committees and
boards.
TITLE X--NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
Subtitle A--Research Centers With Respect to Contraception and Research
Centers With Respect to Infertility
SEC. 1001. GRANTS AND CONTRACTS FOR RESEARCH CENTERS.
Subpart 7 of part C of title IV of the Public Health Service Act, as
amended by section 3 of Public Law 101-613, is amended by adding at the
end the following section:
``research centers with respect to contraception and infertility
``Sec. 452A. (a) The Director of the Institute, after consultation
with the advisory council for the Institute, shall make grants to, or
enter into contracts with, public or nonprofit private entities for the
development and operation of centers to conduct activities for the
purpose of improving methods of contraception and centers to conduct
activities for the purpose of improving methods of diagnosis and
treatment of infertility.
``(b) In carrying out subsection (a), the Director of the Institute
shall, subject to the extent of amounts made available in appropriations
Acts, provide for the establishment of three centers with respect to
contraception and for two centers with respect to infertility.
``(c)(1) Each center assisted under this section shall, in carrying
out the purpose of the center involved--
``(A) conduct clinical and other applied research, including--
``(i) for centers with respect to contraception, clinical
trials of new or improved drugs and devices for use by males and
females (including barrier methods); and
``(ii) for centers with respect to infertility, clinical
trials of new or improved drugs and devices for the diagnosis
and treatment of infertility in males and females;
``(B) develop protocols for training physicians, scientists,
nurses, and other health and allied health professionals;
``(C) conduct training programs for such individuals;
``(D) develop model continuing education programs for such
professionals; and
``(E) disseminate information to such professionals and the
public.
``(2) A center may use funds provided under subsection (a) to
provide stipends for health and allied health professionals enrolled in
programs described in subparagraph (C) of paragraph (1), and to provide
fees to individuals serving as subjects in clinical trials conducted
under such paragraph.
``(d) The Director of the Institute shall, as appropriate, provide
for the coordination of information among the centers assisted under
this section.
``(e) Each center assisted under subsection (a) shall use the
facilities of a single institution, or be formed from a consortium of
cooperating institutions, meeting such requirements as may be prescribed
by the Director of the Institute.
``(f) Support of a center under subsection (a) may be for a period
not exceeding 5 years. Such period may be extended for one or more
additional periods not exceeding 5 years if the operations of such
center have been reviewed by an appropriate technical and scientific
peer review group established by the Director and if such group has
recommended to the Director that such period should be extended.
``(g) For the purpose of carrying out this section, there are
authorized to be appropriated $30,000,000 for fiscal year 1994, and such
sums as may be necessary for each of the fiscal years 1995 and 1996.''.
SEC. 1002. LOAN REPAYMENT PROGRAM FOR RESEARCH WITH RESPECT TO
CONTRACEPTION AND INFERTILITY.
Part G of title IV of the Public Health Service Act, as redesignated
by section 141(a)(2) of this Act, is amended by inserting after section
487A the following section:
``loan repayment program for research with respect to contraception
and infertility
``Sec. 487B. (a) The Secretary, in consultation with the Director of
the National Institute of Child Health and Human Development, shall
establish a program of entering into contracts with qualified health
professionals (including graduate students) under which such health
professionals agree to conduct research with respect to contraception,
or with respect to infertility, in consideration of the Federal
Government agreeing to repay, for each year of such service, not more
than $20,000 of the principal and interest of the educational loans of
such health professionals.
``(b) The provisions of sections 338B, 338C, and 338E shall, except
as inconsistent with subsection (a) of this section, apply to the
program established in subsection (a) to the same extent and in the same
manner as such provisions apply to the National Health Service Corps
Loan Repayment Program established in subpart III of part D of title
III.
``(c) Amounts available for carrying out this section shall remain
available until the expiration of the second fiscal year beginning after
the fiscal year for which the amounts were made available.''.
Subtitle B--Program Regarding Obstetrics and Gynecology
SEC. 1011. ESTABLISHMENT OF PROGRAM.
Subpart 7 of part C of title IV of the Public Health Service Act, as
amended by section 1001 of this Act, is amended by adding at the end the
following section:
``program regarding obstetrics and gynecology
``Sec. 452B. The Director of the Institute shall establish and
maintain within the Institute an intramural laboratory and clinical
research program in obstetrics and gynecology.''.
Subtitle C--Child Health Research Centers
SEC. 1021. ESTABLISHMENT OF CENTERS.
Subpart 7 of part C of title IV of the Public Health Service Act, as
amended by section 1011 of this Act, is amended by adding at the end the
following section:
``child health research centers
``Sec. 452C. The Director of the Institute shall develop and support
centers for conducting research with respect to child health. Such
centers shall give priority to the expeditious transfer of advances from
basic science to clinical applications and improving the care of infants
and children.''.
Subtitle D--Study Regarding Adolescent Health
SEC. 1031. PROSPECTIVE LONGITUDINAL STUDY.
Subpart 7 of part C of title IV of the Public Health Service Act, as
amended by section 1021 of this Act, is amended by adding at the end the
following section:
``prospective longitudinal study on adolescent health
``Sec. 452D. (a) In General.--Not later than October 1, 1993, the
Director of the Institute shall commence a study for the purpose of
providing information on the general health and well-being of
adolescents in the United States, including, with respect to such
adolescents, information on--
``(1) the behaviors that promote health and the behaviors that
are detrimental to health; and
``(2) the influence on health of factors particular to the
communities in which the adolescents reside.
``(b) Design of Study.--
``(1) In general.--The study required in subsection (a) shall be
a longitudinal study in which a substantial number of adolescents
participate as subjects. With respect to the purpose described in
such subsection, the study shall monitor the subjects throughout the
period of the study to determine the health status of the subjects
and any change in such status over time.
``(2) Population-specific analyses.--The study required in
subsection (a) shall be conducted with respect to the population of
adolescents who are female, the population of adolescents who are
male, various socioeconomic populations of adolescents, and various
racial and ethnic populations of adolescents. The study shall be
designed and conducted in a manner sufficient to provide for a valid
analysis of whether there are significant differences among such
populations in health status and whether and to what extent any such
differences are due to factors particular to the populations
involved.
``(c) Coordination With Women's Health Initiative.--With respect to
the national study of women being conducted by the Secretary and known
as the Women's Health Initiative, the Secretary shall ensure that such
study is coordinated with the component of the study required in
subsection (a) that concerns adolescent females, including coordination
in the design of the 2 studies.''.
TITLE XI--NATIONAL EYE INSTITUTE
SEC. 1101. CLINICAL AND HEALTH SERVICES RESEARCH ON EYE CARE AND
DIABETES.
(a) In General.--Subpart 9 of part C of title IV of the Public
Health Service Act (42 U.S.C. 285i) is amended by adding at the end the
following section:
``clinical research on eye care and diabetes
``Sec. 456. (a) Program of Grants.--The Director of the Institute,
in consultation with the advisory council for the Institute, may award
research grants to one or more Diabetes Eye Research Institutions for
the support of programs in clinical or health services aimed at--
``(1) providing comprehensive eye care services for people with
diabetes, including a full complement of preventive, diagnostic and
treatment procedures;
``(2) developing new and improved techniques of patient care
through basic and clinical research;
``(3) assisting in translation of the latest research advances
into clinical practice; and
``(4) expanding the knowledge of the eye and diabetes through
further research.
``(b) Use of Funds.--Amounts received under a grant awarded under
this section shall be used for the following:
``(1) Establishing the biochemical, cellular, and genetic
mechanisms associated with diabetic eye disease and the earlier
detection of pending eye abnormalities. The focus of work under this
paragraph shall require that ophthalmologists have training in the
most up-to-date molecular and cell biological methods.
``(2) Establishing new frontiers in technology, such as video-
based diagnostic and research resources, to--
``(A) provide improved patient care;
``(B) provide for the evaluation of retinal physiology and
its affect on diabetes; and
``(C) provide for the assessment of risks for the
development and progression of diabetic eye disease and a more
immediate evaluation of various therapies aimed at preventing
diabetic eye disease.
Such technologies shall be designed to permit evaluations to be
performed both in humans and in animal models.
``(3) The translation of the results of vision research into the
improved care of patients with diabetic eye disease. Such
translation shall require the application of institutional resources
that encompass patient care, clinical research and basic laboratory
research.
``(4) The conduct of research concerning the outcomes of eye
care treatments and eye health education programs as they relate to
patients with diabetic eye disease, including the evaluation of
regional approaches to such research.
``(c) Authorized Expenditures.--The purposes for which a grant under
subsection (a) may be expended include equipment for the research
described in such subsection.''.
(b) Conforming Amendment.--Section 455 of the Public Health Service
Act (42 U.S.C. 285i) is amended in the second sentence by striking ``The
Director'' and inserting ``Subject to section 456, the Director''.
TITLE XII--NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
SEC. 1201. RESEARCH ON MULTIPLE SCLEROSIS.
Subpart 10 of part C of title IV of the Public Health Service Act
(42 U.S.C. 285j et seq.) is amended by adding at the end the following
section:
``research on multiple sclerosis
``Sec. 460. The Director of the Institute shall conduct and support
research on multiple sclerosis, especially research on effects of
genetics and hormonal changes on the progress of the disease.''.
TITLE XIII--NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
SEC. 1301. APPLIED TOXICOLOGICAL RESEARCH AND TESTING PROGRAM.
(a) In General.--Subpart 12 of part C of title IV of the Public
Health Service Act (42 U.S.C. 285l) is amended by adding at the end the
following section:
``applied toxicological research and testing program
``Sec. 463A. (a) There is established within the Institute a program
for conducting applied research and testing regarding toxicology, which
program shall be known as the Applied Toxicological Research and Testing
Program.
``(b) In carrying out the program established under subsection (a),
the Director of the Institute shall, with respect to toxicology, carry
out activities--
``(1) to expand knowledge of the health effects of environmental
agents;
``(2) to broaden the spectrum of toxicology information that is
obtained on selected chemicals;
``(3) to develop and validate assays and protocols, including
alternative methods that can reduce or eliminate the use of animals
in acute or chronic safety testing;
``(4) to establish criteria for the validation and regulatory
acceptance of alternative testing and to recommend a process through
which scientifically validated alternative methods can be accepted
for regulatory use;
``(5) to communicate the results of research to government
agencies, to medical, scientific, and regulatory communities, and to
the public; and
``(6) to integrate related activities of the Department of
Health and Human Services.''.
(b) Technical Amendment.--Section 463 of the Public Health Service
Act (42 U.S.C. 285l) is amended by inserting after ``Sciences'' the
following: ``(in this subpart referred to as the `Institute')''.
TITLE XIV--NATIONAL LIBRARY OF MEDICINE
Subtitle A--General Provisions
SEC. 1401. ADDITIONAL AUTHORITIES.
(a) In General.--Section 465(b) of the Public Health Service Act (42
U.S.C. 286(b)) is amended--
(1) by striking ``and'' after the semicolon at the end of
paragraph (5);
(2) by redesignating paragraph (6) as paragraph (8); and
(3) by inserting after paragraph (5) the following paragraphs:
``(6) publicize the availability from the Library of the
products and services described in any of paragraphs (1) through
(5);
``(7) promote the use of computers and telecommunications by
health professionals (including health professionals in rural areas)
for the purpose of improving access to biomedical information for
health care delivery and medical research; and''.
(b) Limitation Regarding Grants.--Section 474(b)(2) of the Public
Health Service Act (42 U.S.C. 286b-5(b)(2)) is amended by striking
``$750,000'' and inserting ``$1,000,000''.
(c) Technical and Conforming Amendments.--
(1) Repeal of certain authority.--Section 215 of the Department
of Health and Human Services Appropriations Act, 1988, as contained
in section 101(h) of Public Law 100-202 (101 Stat. 1329-275), is
repealed.
(2) Applicability of certain new authority.--With respect to the
authority established for the National Library of Medicine in
section 465(b)(6) of the Public Health Service Act, as added by
subsection (a) of this section, such authority shall be effective as
if the authority had been established on December 22, 1987.
SEC. 1402. AUTHORIZATION OF APPROPRIATIONS.
(a) Establishment of Single Authorization.--Subpart 1 of part D of
title IV of the Public Health Service Act (42 U.S.C. 286 et seq.) is
amended by adding at the end the following section:
``authorization of appropriations
``Sec. 468. (a) For the purpose of carrying out this part, there are
authorized to be appropriated $150,000,000 for fiscal year 1994, and
such sums as may be necessary for each of the fiscal years 1995 and
1996.
``(b) Amounts appropriated under subsection (a) and made available
for grants or contracts under any of sections 472 through 476 shall
remain available until the end of the fiscal year following the fiscal
year for which the amounts were appropriated.''.
(b) Conforming Amendments.--Part D of title IV of the Public Health
Service Act (42 U.S.C. 286 et seq.) is amended by striking section 469
and section 478(c).
Subtitle B--Financial Assistance
SEC. 1411. ESTABLISHMENT OF PROGRAM OF GRANTS FOR DEVELOPMENT OF
EDUCATION TECHNOLOGIES.
Section 473 of the Public Health Service Act (42 U.S.C. 286b-4) is
amended by adding at the end the following subsection:
``(c)(1) The Secretary shall make grants to public or nonprofit
private institutions for the purpose of carrying out projects of
research on, and development and demonstration of, new education
technologies.
``(2) The purposes for which a grant under paragraph (1) may be made
include projects concerning--
``(A) computer-assisted teaching and testing of clinical
competence at health professions and research institutions;
``(B) the effective transfer of new information from research
laboratories to appropriate clinical applications;
``(C) the expansion of the laboratory and clinical uses of
computer-stored research databases; and
``(D) the testing of new technologies for training health care
professionals.
``(3) The Secretary may not make a grant under paragraph (1) unless
the applicant for the grant agrees to make the projects available with
respect to--
``(A) assisting in the training of health professions students;
and
``(B) enhancing and improving the capabilities of health
professionals regarding research and teaching.''.
Subtitle C--National Information Center on Health Services Research and
Health Care Technology
SEC. 1421. ESTABLISHMENT OF CENTER.
Part D of title IV of the Public Health Service Act (42 U.S.C. 286
et seq.) is amended by adding at the end the following subpart:
``Subpart 4--National Information Center on Health Services Research and
Health Care Technology
``national information center
``Sec. 478A. (a) There is established within the Library an entity
to be known as the National Information Center on Health Services
Research and Health Care Technology (in this section referred to as the
`Center').
``(b) The purpose of the Center is the collection, storage,
analysis, retrieval, and dissemination of information on health services
research, clinical practice guidelines, and on health care technology,
including the assessment of such technology. Such purpose includes
developing and maintaining data bases and developing and implementing
methods of carrying out such purpose.
``(c) The Director of the Center shall ensure that information under
subsection (b) concerning clinical practice guidelines is collected and
maintained electronically and in a convenient format. Such Director
shall develop and publish criteria for the inclusion of practice
guidelines and technology assessments in the information center
database.
``(d) The Secretary, acting through the Center, shall coordinate the
activities carried out under this section through the Center with
related activities of the Administrator for Health Care Policy and
Research.''.
SEC. 1422. CONFORMING PROVISIONS.
(a) In General.--Section 903 of the Public Health Service Act, as
amended by section 3 of Public Law 102-410 (106 Stat. 2094), is amended
by amending subsection (e) to read as follows:
``(e) Required Interagency Agreement.--The Administrator and the
Director of the National Library of Medicine shall enter into an
agreement providing for the implementation of section 478A.''.
(b) Rule of Construction.--The amendments made by section 3 of
Public Law 102-410 (106 Stat. 2094), by section 1421 of this Act, and by
subsection (a) of this section may not be construed as terminating the
information center on health care technologies and health care
technology assessment established under section 904 of the Public Health
Service Act, as in effect on the day before the date of the enactment of
Public Law 102-410. Such center shall be considered to be the center
established in section 478A of the Public Health Service Act, as added
by section 1421 of this Act, and shall be subject to the provisions of
such section 478A.
TITLE XV--OTHER AGENCIES OF NATIONAL INSTITUTES OF HEALTH
Subtitle A--Division of Research Resources
SEC. 1501. REDESIGNATION OF DIVISION AS NATIONAL CENTER FOR RESEARCH
RESOURCES.
Title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) is
amended--
(1) in section 401(b)(2)(B), by amending such subparagraph to
read as follows:
``(B) The National Center for Research Resources.''; and
(2) in part E--
(A) in the heading for subpart 1, by striking ``Division
of'' and inserting ``National Center for'';
(B) in section 479, by striking ``the Division of Research
Resources'' and inserting the following: ``the National Center
for Research Resources (in this subpart referred to as the
`Center')'';
(C) in sections 480 and 481, by striking ``the Division of
Research Resources'' each place such term appears and inserting
``the Center''; and
(D) in sections 480 and 481, as amended by subparagraph (C),
by striking ``the Division'' each place such term appears and
inserting ``the Center''.
SEC. 1502. BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES.
Subpart 1 of part E of title IV of the Public Health Service Act (42
U.S.C. 287 et seq.) is amended by adding at the end the following
section:
``biomedical and behavioral research facilities
``Sec. 481A. (a) Modernization and Construction of Facilities.--
``(1) In general.--The Director of NIH, acting through the
Director of the Center, may make grants to public and nonprofit
private entities to expand, remodel, renovate, or alter existing
research facilities or construct new research facilities, subject to
the provisions of this section.
``(2) Construction and cost of construction.--For purposes of
this section, the terms `construction' and `cost of construction'
include the construction of new buildings and the expansion,
renovation, remodeling, and alteration of existing buildings,
including architects' fees, but do not include the cost of
acquisition of land or off-site improvements.
``(b) Scientific and Technical Review Boards for Merit-Based Review
of Proposals.--
``(1) In general; approval as precondition to grants.--
``(A) There is established within the Center a Scientific
and Technical Review Board on Biomedical and Behavioral Research
Facilities (referred to in this section as the `Board').
``(B) The Director of the Center may approve an application
for a grant under subsection (a) only if the Board has under
paragraph (2) recommended the application for approval.
``(2) Duties.--
``(A) The Board shall provide advice to the Director of the
Center and the advisory council established under section 480
(in this section referred to as the `Advisory Council') on
carrying out this section.
``(B) In carrying out subparagraph (A), the Board shall make
a determination of the merit of each application submitted for a
grant under subsection (a), after consideration of the
requirements established in subsection (c), and shall report the
results of the determination to the Director of the Center and
the Advisory Council. Such determinations shall be conducted in
a manner consistent with procedures established under section
492.
``(C) In carrying out subparagraph (A), the Board shall, in
the case of applications recommended for approval, make
recommendations to the Director and the Advisory Council on the
amount that should be provided in the grant.
``(D) In carrying out subparagraph (A), the Board shall
prepare an annual report for the Director of the Center and the
Advisory Council describing the activities of the Board in the
fiscal year for which the report is made. Each such report shall
be available to the public, and shall--
``(i) summarize and analyze expenditures made under this
section;
``(ii) provide a summary of the types, numbers, and
amounts of applications that were recommended for grants
under subsection (a) but that were not approved by the
Director of the Center; and
``(iii) contain the recommendations of the Board for any
changes in the administration of this section.
``(3) Membership.--
``(A) Subject to subparagraph (B), the Board shall be
composed of 9 appointed members, and such ex officio members as
the Director of the Center determines to be appropriate.
``(B) Not more than 3 individuals who are officers or
employees of the Federal Government may serve as members of the
Board.
``(4) Certain requirements regarding membership.--In selecting
individuals for membership on the Board, the Director of the Center
shall ensure that the members are individuals who, by virtue of
their training or experience, are eminently qualified to perform
peer review functions. In selecting such individuals for such
membership, the Director of the Center shall ensure that the members
of the Board collectively--
``(A) are experienced in the planning, construction,
financing, and administration of entities that conduct
biomedical or behavioral research sciences;
``(B) are knowledgeable in making determinations of the need
of entities for biomedical or behavioral research facilities,
including such facilities for the dentistry, nursing, pharmacy,
and allied health professions;
``(C) are knowledgeable in evaluating the relative
priorities for applications for grants under subsection (a) in
view of the overall research needs of the United States; and
``(D) are experienced with emerging centers of excellence,
as described in subsection (c)(3).
``(5) Certain authorities.--
``(A) In carrying out paragraph (2), the Board may convene
workshops and conferences, and collect data as the Board
considers appropriate.
``(B) In carrying out paragraph (2), the Board may establish
subcommittees within the Board. Such subcommittees may hold
meetings as determined necessary to enable the subcommittee to
carry out its duties.
``(6) Terms.--
``(A) Except as provided in subparagraph (B), each appointed
member of the Board shall hold office for a term of 4 years. Any
member appointed to fill a vacancy occurring prior to the
expiration of the term for which such member's predecessor was
appointed shall be appointed for the remainder of the term of
the predecessor.
``(B) Of the initial members appointed to the Board (as
specified by the Director of the Center when making the
appointments)--
``(i) 3 shall hold office for a term of 3 years;
``(ii) 3 shall hold office for a term of 2 years; and
``(iii) 3 shall hold office for a term of 1 year.
``(C) No member is eligible for reappointment to the Board
until 1 year has elapsed after the end of the most recent term
of the member.
``(7) Compensation.--Members of the Board who are not officers
or employees of the United States shall receive for each day the
members are engaged in the performance of the functions of the Board
compensation at the same rate received by members of other national
advisory councils established under this title.
``(c) Requirements for Grants.--
``(1) In general.--The Director of the Center may make a grant
under subsection (a) only if the applicant for the grant meets the
following conditions:
``(A) The applicant is determined by such Director to be
competent to engage in the type of research for which the
proposed facility is to be constructed.
``(B) The applicant provides assurances satisfactory to the
Director that--
``(i) for not less than 20 years after completion of the
construction, the facility will be used for the purposes of
research for which it is to be constructed;
``(ii) sufficient funds will be available to meet the
non-Federal share of the cost of constructing the facility;
``(iii) sufficient funds will be available, when
construction is completed, for the effective use of the
facility for the research for which it is being constructed;
and
``(iv) the proposed construction will expand the
applicant's capacity for research, or is necessary to
improve or maintain the quality of the applicant's research.
``(C) The applicant meets reasonable qualifications
established by the Director with respect to--
``(i) the relative scientific and technical merit of the
applications, and the relative effectiveness of the proposed
facilities, in expanding the capacity for biomedical or
behavioral research and in improving the quality of such
research;
``(ii) the quality of the research or training, or both,
to be carried out in the facilities involved;
``(iii) the need of the applicant for such facilities in
order to maintain or expand the applicant's research and
training mission;
``(iv) the congruence of the research activities to be
carried out within the facility with the research and
investigator manpower needs of the United States; and
``(v) the age and condition of existing research
facilities and equipment.
``(D) The applicant has demonstrated a commitment to
enhancing and expanding the research productivity of the
applicant.
``(2) Consideration of certain factors.--In making grants under
subsection (a), the Director of the Center may, in addition to the
requirements established in paragraph (1), consider the following
factors:
``(A) To what extent the applicant has the capacity to
broaden the scope of research and research training programs of
the applicant by promoting--
``(i) interdisciplinary research;
``(ii) research on emerging technologies, including
those involving novel analytical techniques or computational
methods; or
``(iii) other novel research mechanisms or programs.
``(B) To what extent the applicant has broadened the scope
of research and research training programs of qualified
institutions by promoting genomic research with an emphasis on
interdisciplinary research, including research related to
pediatric investigations.
``(3) Institutions of emerging excellence.--Of the amounts
appropriated under subsection (h) for a fiscal year, the Director of
the Center shall make available 25 percent for grants under
subsection (a) to applicants that, in addition to meeting the
requirements established in paragraph (1), have demonstrated
emerging excellence in biomedical or behavioral research, as
follows:
``(A) The applicant has a plan for research or training
advancement and possesses the ability to carry out the plan.
``(B) The applicant carries out research and research
training programs that have a special relevance to a problem,
concern, or unmet health need of the United States.
``(C) The applicant has been productive in research or
research development and training.
``(D) The applicant--
``(i) has been designated as a center of excellence
under section 739;
``(ii) is located in a geographic area whose population
includes a significant number of individuals with a health-
status deficit, and the applicant provides health services
to such individuals; or
``(iii) is located in a geographic area in which a
deficit in health care technology, services, or research
resources may adversely affect health status of the
population of the area in the future, and the applicant is
carrying out activities with respect to protecting the
health status of such population.
``(d) Requirement of Application.--The Director of the Center may
make a grant under subsection (a) only if an application for the grant
is submitted to the Director and the application is in such form, is
made in such manner, and contains such agreements, assurances, and
information as the Director determines to be necessary to carry out this
section.
``(e) Amount of Grant; Payments.--
``(1) Amount.--The amount of any grant awarded under subsection
(a) shall be determined by the Director of the Center, except that
such amount shall not exceed--
``(A) 50 percent of the necessary cost of the construction
of a proposed facility as determined by the Director; or
``(B) in the case of a multipurpose facility, 40 percent of
that part of the necessary cost of construction that the
Director determines to be proportionate to the contemplated use
of the facility.
``(2) Reservation of amounts.--On approval of any application
for a grant under subsection (a), the Director of the Center shall
reserve, from any appropriation available therefore, the amount of
such grant, and shall pay such amount, in advance or by way of
reimbursement, and in such installments consistent with the
construction progress, as the Director may determine appropriate.
The reservation of the Director of any amount by the Director under
this paragraph may be amended by the Director, either on the
approval of an amendment of the application or on the revision of
the estimated cost of construction of the facility.
``(3) Exclusion of certain costs.--In determining the amount of
any grant under this subsection (a), there shall be excluded from
the cost of construction an amount equal to the sum of--
``(A) the amount of any other Federal grant that the
applicant has obtained, or is assured of obtaining, with respect
to construction that is to be financed in part by a grant
authorized under this section; and
``(B) the amount of any non-Federal funds required to be
expended as a condition of such other Federal grant.
``(4) Waiver of limitations.--The limitations imposed by
paragraph (1) may be waived at the discretion of the Director for
applicants meeting the conditions described in paragraphs (1) and
(2) of subsection (c).
``(f) Recapture of Payments.--If, not later than 20 years after the
completion of construction for which a grant has been awarded under
subsection (a)--
``(1) the applicant or other owner of the facility shall cease
to be a public or nonprofit private entity; or
``(2) the facility shall cease to be used for the research
purposes for which it was constructed (unless the Director
determines, in accordance with regulations, that there is good cause
for releasing the applicant or other owner from obligation to do
so);
the United States shall be entitled to recover from the applicant or
other owner of the facility the amount bearing the same ratio to the
current value (as determined by an agreement between the parties or by
action brought in the United States District Court for the district in
which such facility is situated) of the facility as the amount of the
Federal participation bore to the cost of the construction of such
facility.
``(g) Guidelines.--Not later than 6 months after the date of the
enactment of this section, the Director of the Center, after
consultation with the Advisory Council, shall issue guidelines with
respect to grants under subsection (a).
``(h) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated $150,000,000
for fiscal year 1994, and such sums as may be necessary for each of the
fiscal years 1995 and 1996.''.
SEC. 1503. CONSTRUCTION PROGRAM FOR NATIONAL PRIMATE RESEARCH CENTER.
Subpart 1 of part E of title IV of the Public Health Service Act, as
amended by section 1502 of this Act, is amended by adding at the end the
following section:
``construction of regional centers for research on primates
``Sec. 481B. (a) With respect to activities carried out by the
National Center for Research Resources to support regional centers for
research on primates, the Director of NIH shall, for each of the fiscal
years 1994 through 1996, reserve from the amounts appropriated under
section 481A(h) $5,000,000 for the purpose of making awards of grants
and contracts to public or nonprofit private entities to construct,
renovate, or otherwise improve such regional centers. The reservation of
such amounts for any fiscal year is subject to the availability of
qualified applicants for such awards.
``(b) The Director of NIH may not make a grant or enter into a
contract under subsection (a) unless the applicant for such assistance
agrees, with respect to the costs to be incurred by the applicant in
carrying out the purpose described in such subsection, to make available
(directly or through donations from public or private entities) non-
Federal contributions in cash toward such costs in an amount equal to
not less than $1 for each $4 of Federal funds provided in such
assistance.''.
Subtitle B--National Center for Nursing Research
SEC. 1511. REDESIGNATION OF NATIONAL CENTER FOR NURSING RESEARCH AS
NATIONAL INSTITUTE OF NURSING RESEARCH.
(a) In General.--Subpart 3 of part E of title IV of the Public
Health Service Act (42 U.S.C. 287c et seq.) is amended--
(1) in section 483--
(A) in the heading for the section, by striking ``center''
and inserting ``institute''; and
(B) by striking ``The general purpose'' and all that follows
through ``is'' and inserting the following: ``The general
purpose of the National Institute of Nursing Research (in this
subpart referred to as the `Institute') is'';
(2) in section 484, by striking ``Center'' each place such term
appears and inserting ``Institute'';
(3) in section 485--
(A) in subsection (a), in each of paragraphs (1) through
(3), by striking ``Center'' each place such term appears and
inserting ``Institute'';
(B) in subsection (b)--
(i) in paragraph (2)(A), by striking ``Center'' and
inserting ``Institute''; and
(ii) in paragraph (3)(A), in the first sentence, by
striking ``Center'' and inserting ``Institute''; and
(C) in subsections (d) through (g), by striking ``Center''
each place such term appears and inserting ``Institute''; and
(4) in section 485A (as redesignated by section 141(a)(1) of
this Act), by striking ``Center'' each place such term appears and
inserting ``Institute''.
(b) Conforming Amendments.--
(1) Organization of national institutes of health.--Section
401(b) of the Public Health Service Act (42 U.S.C. 281(b)) is
amended--
(A) in paragraph (1), by adding at the end the following
subparagraph:
``(Q) The National Institute of Nursing Research.''; and
(B) in paragraph (2), by striking subparagraph (D).
(2) Transfer of statutory provisions.--The Public Health Service
Act, as amended by subsection (a) of this section and by section 124
of Public Law 102-321 (106 Stat. 364), is amended--
(A) by transferring sections 483 through 485A to part C of
title IV;
(B) by redesignating such sections as sections 464V through
464Y of such part; and
(C) by adding such sections, in the appropriate sequence, at
the end of such part.
(3) Heading for new subpart.--Title IV of the Public Health
Service Act, as amended by the preceding provisions of this section,
is amended--
(A) in part C, by inserting before section 464V the
following:
``Subpart 17--National Institute of Nursing Research'';
and
(B) by striking the subpart designation and heading for
subpart 3 of part E.
(4) Cross-references.--Title IV of the Public Health Service
Act, as amended by the preceding provisions of this section, is
amended in subpart 17 of part C--
(A) in section 464W, by striking ``section 483'' and
inserting ``section 464V'';
(B) in section 464X(g), by striking ``section 486'' and
inserting ``section 464Y''; and
(C) in section 464Y, in the last sentence, by striking
``section 485(g)'' and inserting ``section 464X(g)''.
SEC. 1512. STUDY ON ADEQUACY OF NUMBER OF NURSES.
(a) In General.--The Secretary of Health and Human Services, acting
through the Director of the National Institute of Nursing Research,
shall enter into a contract with a public or nonprofit private entity to
conduct a study for the purpose of determining whether and to what
extent there is a need for an increase in the number of nurses in
hospitals and nursing homes in order to promote the quality of patient
care and reduce the incidence among nurses of work-related injuries and
stress.
(b) National Academy of Sciences.--The Secretary shall request the
Institute of Medicine of the National Academy of Sciences to enter into
the contract under subsection (a) to conduct the study described in such
subsection. If such Institute declines to conduct the study, the
Secretary shall carry out such subsection through another public or
nonprofit private entity.
(c) Definitions.--For purposes of this section:
(1) The term ``nurse'' means a registered nurse, a licensed
practical nurse, a licensed vocational nurse, and a nurse assistant.
(2) The term ``Secretary'' means the Secretary of Health and
Human Services.
(d) Report.--The Secretary shall ensure that, not later than 18
months after the date of the enactment of this Act, the study required
in subsection (a) is completed and a report describing the findings made
as a result of the study is submitted to the Committee on Energy and
Commerce of the House of Representatives and to the Committee on Labor
and Human Resources of the Senate.
Subtitle C--National Center for Human Genome Research
SEC. 1521. PURPOSE OF CENTER.
Title IV of the Public Health Service Act, as amended by section
141(a)(1) of this Act and by paragraphs (1)(B) and (3)(B) of section
1511(b) of this Act, is amended--
(1) in section 401(b)(2), by adding at the end the following
subparagraph:
``(D) The National Center for Human Genome Research.''; and
(2) in part E, by adding at the end the following subpart:
``Subpart 3--National Center for Human Genome Research
``purpose of the center
``Sec. 485B. (a) The general purpose of the National Center for
Human Genome Research (in this subpart referred to as the `Center') is
to characterize the structure and function of the human genome,
including the mapping and sequencing of individual genes. Such purpose
includes--
``(1) planning and coordinating the research goal of the genome
project;
``(2) reviewing and funding research proposals;
``(3) developing training programs;
``(4) coordinating international genome research;
``(5) communicating advances in genome science to the public;
and
``(6) reviewing and funding proposals to address the ethical and
legal issues associated with the genome project (including legal
issues regarding patents).
``(b) The Director of the Center may conduct and support research
training--
``(1) for which fellowship support is not provided under section
487; and
``(2) that is not residency training of physicians or other
health professionals.
``(c)(1) Except as provided in paragraph (2), of the amounts
appropriated to carry out subsection (a) for a fiscal year, the Director
of the Center shall make available not less than 5 percent for carrying
out paragraph (6) of such subsection.
``(2) With respect to providing funds under subsection (a)(6) for
proposals to address the ethical issues associated with the genome
project, paragraph (1) shall not apply for a fiscal year if the Director
of the Center certifies to the Committee on Energy and Commerce of the
House of Representatives, and to the Committee on Labor and Human
Resources of the Senate, that the Director has determined that an
insufficient number of such proposals meet the applicable requirements
of sections 491 and 492.''.
TITLE XVI--AWARDS AND TRAINING
Subtitle A--National Research Service Awards
SEC. 1601. REQUIREMENT REGARDING WOMEN AND INDIVIDUALS FROM
DISADVANTAGED BACKGROUNDS.
Section 487(a) of the Public Health Service Act (42 U.S.C.
288(a)(4)) is amended by adding at the end the following paragraph:
``(4) The Secretary shall carry out paragraph (1) in a manner that
will result in the recruitment of women, and individuals from
disadvantaged backgrounds (including racial and ethnic minorities), into
fields of biomedical or behavioral research and in the provision of
research training to women and such individuals.''.
SEC. 1602. SERVICE PAYBACK REQUIREMENTS.
Section 487(c) of the Public Health Service Act (42 U.S.C. 288(c))
is amended by striking paragraphs (1) and (2) and inserting the
following: ``(1) Each individual who is awarded a National Research
Service Award for postdoctoral research training shall, in accordance
with paragraph (3), engage in research training, research, or teaching
that is health-related (or any combination thereof) for the period
specified in paragraph (2). Such period shall be served in accordance
with the usual patterns of scientific employment.
``(2)(A) The period referred to in paragraph (1) is 12 months, or
one month for each month for which the individual involved receives a
National Research Service Award for postdoctoral research training,
whichever is less.
``(B) With respect to postdoctoral research training, in any case in
which an individual receives a National Research Service Award for more
than 12 months, the 13th month and each subsequent month of performing
activities under the Award shall be considered to be activities engaged
in toward satisfaction of the requirement established in paragraph (1)
regarding a period of service.''.
Subtitle B--Acquired Immune Deficiency Syndrome
SEC. 1611. LOAN REPAYMENT PROGRAM.
(a) In General.--Section 487A of the Public Health Service Act (42
U.S.C. 288-1) is amended to read as follows:
``loan repayment program for research with respect to acquired immune
deficiency syndrome
``Sec. 487A. (a) In General.--The Secretary shall carry out a
program of entering into agreements with appropriately qualified health
professionals under which such health professionals agree to conduct, as
employees of the National Institutes of Health, research with respect to
acquired immune deficiency syndrome in consideration of the Federal
Government agreeing to repay, for each year of such service, not more
than $20,000 of the principal and interest of the educational loans of
such health professionals.
``(b) Applicability of Certain Provisions.--With respect to the
National Health Service Corps Loan Repayment Program established in
subpart III of part D of title III, the provisions of such subpart
shall, except as inconsistent with subsection (a) of this section, apply
to the program established in such subsection (a) in the same manner and
to the same extent as such provisions apply to the National Health
Service Corps Loan Repayment Program established in such subpart.
``(c) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated such sums as
may be necessary for each of the fiscal years 1994 through 1996.''.
(b) Applicability.--The amendment made by subsection (a) does not
apply to any agreement entered into under section 487A of the Public
Health Service Act before the date of the enactment of this Act. Each
such agreement continues to be subject to the terms of the agreement in
effect on the day before such date.
Subtitle C--Loan Repayment for Research Generally
SEC. 1621. ESTABLISHMENT OF PROGRAM.
Part G of title IV of the Public Health Service Act, as redesignated
by section 141(a)(2) of this Act and as amended by section 1002 of this
Act, is amended by inserting after section 487B the following section:
``loan repayment program for research generally
``Sec. 487C. (a) In General.--
``(1) Authority for program.--Subject to paragraph (2), the
Secretary shall carry out a program of entering into contracts with
appropriately qualified health professionals under which such health
professionals agree to conduct research, as employees of the
National Institutes of Health, in consideration of the Federal
Government agreeing to repay, for each year of such service, not
more than $20,000 of the principal and interest of the educational
loans of such health professionals.
``(2) Limitation.--The Secretary may not enter into an agreement
with a health professional pursuant to paragraph (1) unless such
professional--
``(A) has a substantial amount of educational loans relative
to income; and
``(B) agrees to serve as an employee of the National
Institutes of Health for purposes of paragraph (1) for a period
of not less than 3 years.
``(b) Applicability of Certain Provisions.--With respect to the
National Health Service Corps Loan Repayment Program established in
subpart III of part D of title III, the provisions of such subpart
shall, except as inconsistent with subsection (a) of this section, apply
to the program established in such subsection (a) in the same manner and
to the same extent as such provisions apply to the National Health
Service Corps Loan Repayment Program established in such subpart.''.
Subtitle D--Scholarship and Loan Repayment Programs Regarding
Professional Skills Needed by Certain Agencies
SEC. 1631. ESTABLISHMENT OF PROGRAMS FOR NATIONAL INSTITUTES OF
HEALTH.
Part G of title IV of the Public Health Service Act, as redesignated
by section 141(a)(2) of this Act and as amended by section 1621 of this
Act, is amended by inserting after section 487C the following sections:
``undergraduate scholarship program regarding professions needed by
national research institutes
``Sec. 487D. (a) Establishment of Program.--
``(1) In general.--Subject to section 487(a)(1)(C), the
Secretary, acting through the Director of NIH, may carry out a
program of entering into contracts with individuals described in
paragraph (2) under which--
``(A) the Director of NIH agrees to provide to the
individuals scholarships for pursuing, as undergraduates at
accredited institutions of higher education, academic programs
appropriate for careers in professions needed by the National
Institutes of Health; and
``(B) the individuals agree to serve as employees of the
National Institutes of Health, for the period described in
subsection (c), in positions that are needed by the National
Institutes of Health and for which the individuals are
qualified.
``(2) Individuals from disadvantaged backgrounds.--The
individuals referred to in paragraph (1) are individuals who--
``(A) are enrolled or accepted for enrollment as full-time
undergraduates at accredited institutions of higher education;
and
``(B) are from disadvantaged backgrounds.
``(b) Facilitation of Interest of Students in Careers at National
Institutes of Health.--In providing employment to individuals pursuant
to contracts under subsection (a)(1), the Director of NIH shall carry
out activities to facilitate the interest of the individuals in pursuing
careers as employees of the National Institutes of Health.
``(c) Period of Obligated Service.--
``(1) Duration of service.--For purposes of subparagraph (B) of
subsection (a)(1), the period of service for which an individual is
obligated to serve as an employee of the National Institutes of
Health is, subject to paragraph (2)(A), 12 months for each academic
year for which the scholarship under such subsection is provided.
``(2) Schedule for service.--
``(A) Subject to subparagraph (B), the Director of NIH may
not provide a scholarship under subsection (a) unless the
individual applying for the scholarship agrees that--
``(i) the individual will serve as an employee of the
National Institutes of Health full-time for not less than 10
consecutive weeks of each year during which the individual
is attending the educational institution involved and
receiving such a scholarship;
``(ii) the period of service as such an employee that
the individual is obligated to provide under clause (i) is
in addition to the period of service as such an employee
that the individual is obligated to provide under subsection
(a)(1)(B); and
``(iii) not later than 60 days after obtaining the
educational degree involved, the individual will begin
serving full-time as such an employee in satisfaction of the
period of service that the individual is obligated to
provide under subsection (a)(1)(B).
``(B) The Director of NIH may defer the obligation of an
individual to provide a period of service under subsection
(a)(1)(B), if the Director determines that such a deferral is
appropriate.
``(3) Applicability of certain provisions relating to
appointment and compensation.--For any period in which an individual
provides service as an employee of the National Institutes of Health
in satisfaction of the obligation of the individual under subsection
(a)(1)(B) or paragraph (2)(A)(i), the individual may be appointed as
such an employee without regard to the provisions of title 5, United
States Code, relating to appointment and compensation.
``(d) Provisions Regarding Scholarship.--
``(1) Approval of academic program.--The Director of NIH may not
provide a scholarship under subsection (a) for an academic year
unless--
``(A) the individual applying for the scholarship has
submitted to the Director a proposed academic program for the
year and the Director has approved the program; and
``(B) the individual agrees that the program will not be
altered without the approval of the Director.
``(2) Academic standing.--The Director of NIH may not provide a
scholarship under subsection (a) for an academic year unless the
individual applying for the scholarship agrees to maintain an
acceptable level of academic standing, as determined by the
educational institution involved in accordance with regulations
issued by the Secretary.
``(3) Limitation on amount.--The Director of NIH may not provide
a scholarship under subsection (a) for an academic year in an amount
exceeding $20,000.
``(4) Authorized uses.--A scholarship provided under subsection
(a) may be expended only for tuition expenses, other reasonable
educational expenses, and reasonable living expenses incurred in
attending the school involved.
``(5) Contract regarding direct payments to institution.--In the
case of an institution of higher education with respect to which a
scholarship under subsection (a) is provided, the Director of NIH
may enter into a contract with the institution under which the
amounts provided in the scholarship for tuition and other
educational expenses are paid directly to the institution.
``(e) Penalties for Breach of Scholarship Contract.--The provisions
of section 338E shall apply to the program established in subsection (a)
to the same extent and in the same manner as such provisions apply to
the National Health Service Corps Loan Repayment Program established in
section 338B.
``(f) Requirement of Application.--The Director of NIH may not
provide a scholarship under subsection (a) unless an application for the
scholarship is submitted to the Director and the application is in such
form, is made in such manner, and contains such agreements, assurances,
and information as the Director determines to be necessary to carry out
this section.
``(g) Availability of Authorization of Appropriations.--Amounts
appropriated for a fiscal year for scholarships under this section shall
remain available until the expiration of the second fiscal year
beginning after the fiscal year for which the amounts were appropriated.
``loan repayment program regarding clinical researchers from
disadvantaged backgrounds
``Sec. 487E. (a) Implementation of Program.--
``(1) In general.--Subject to section 487(a)(1)(C), the
Secretary, acting through the Director of NIH may, subject to
paragraph (2), carry out a program of entering into contracts with
appropriately qualified health professionals who are from
disadvantaged backgrounds under which such health professionals
agree to conduct clinical research as employees of the National
Institutes of Health in consideration of the Federal Government
agreeing to pay, for each year of such service, not more than
$20,000 of the principal and interest of the educational loans of
the health professionals.
``(2) Limitation.--The Director of NIH may not enter into a
contract with a health professional pursuant to paragraph (1) unless
such professional has a substantial amount of education loans
relative to income.
``(3) Applicability of certain provisions regarding obligated
service.--Except to the extent inconsistent with this section, the
provisions of sections 338C and 338E shall apply to the program
established in paragraph (1) to the same extent and in the same
manner as such provisions apply to the National Health Service Corps
Loan Repayment Program established in section 338B.
``(b) Availability of Authorization of Appropriations.--Amounts
appropriated for a fiscal year for contracts under subsection (a) shall
remain available until the expiration of the second fiscal year
beginning after the fiscal year for which the amounts were
appropriated.''.
SEC. 1632. FUNDING.
Section 487(a)(1) of the Public Health Service Act (42 U.S.C.
288(a)(1)) is amended--
(1) in subparagraph (A), by striking ``and'' after the semicolon
at the end;
(2) in subparagraph (B), by striking the period at the end and
inserting ``; and''; and
(3) by inserting after subparagraph (B) the following
subparagraph:
``(C) provide contracts for scholarships and loan repayments in
accordance with sections 487D and 487E, subject to providing not
more than an aggregate 50 such contracts during the fiscal years
1994 through 1996.''.
Subtitle E--Funding
SEC. 1641. AUTHORIZATION OF APPROPRIATIONS.
Section 487(d) of the Public Health Service Act (42 U.S.C. 288(d))
is amended--
(1) in the first sentence, by amending the sentence to read as
follows: ``For the purpose of carrying out this section, there are
authorized to be appropriated $400,000,000 for fiscal year 1994, and
such sums as may be necessary for each of the fiscal years 1995 and
1996.''; and
(2) in paragraph (3)--
(A) by striking ``one-half of one percent'' each place such
term appears and inserting ``1 percent''; and
(B) by striking ``780, 784, or 786,'' and inserting ``747,
748, or 749,''.
TITLE XVII--NATIONAL FOUNDATION FOR BIOMEDICAL RESEARCH
SEC. 1701. NATIONAL FOUNDATION FOR BIOMEDICAL RESEARCH.
Section 499 of the Public Health Service Act, as redesignated by
section 121(b)(3) of this Act, is amended--
(1) in subsection (a)--
(A) by inserting ``, acting through the Director of NIH,''
after ``Secretary shall''; and
(B) by striking ``, except for'' and all that follows
through ``Transfer Act,'';
(2) by redesignating subsections (c), (d), (e), (f), (g), (h),
and (i) as subsections (d), (f), (g), (h), (i), (j), and (m),
respectively;
(3) by striking subsection (b) and inserting the following
subsections:
``(b) Purpose of Foundation.--The purpose of the Foundation shall be
to support the National Institutes of Health in its mission, and to
advance collaboration with biomedical researchers from universities,
industry, and nonprofit organizations.
``(c) Certain Activities of Foundation.--
``(1) In general.--In carrying out subsection (b), the
Foundation may solicit and accept gifts, grants, and other
donations, establish accounts, and invest and expend funds in
support of the following activities with respect to the purpose
described in such subsection:
``(A) A program to provide and administer endowed positions
that are associated with the research program of the National
Institutes of Health. Such endowments may be expended for the
compensation of individuals holding the positions, for staff,
equipment, quarters, travel, and other expenditures that are
appropriate in supporting the endowed positions.
``(B) A program to provide and administer fellowships and
grants to research personnel in order to work and study in
association with the National Institutes of Health. Such
fellowships and grants may include stipends, travel, health
insurance benefits and other appropriate expenses. The
recipients of fellowships shall be selected by the donors and
the Foundation upon the recommendation of the National
Institutes of Health employees in the laboratory where the
fellow would serve, and shall be subject to the agreement of the
Director of the National Institutes of Health and the Executive
Director of the Foundation.
``(C) Supplementary programs to provide for--
``(i) scientists of other countries to serve in research
capacities in the United States in association with the
National Institutes of Health or elsewhere, or opportunities
for employees of the National Institutes of Health or other
public health officials in the United States to serve in
such capacities in other countries, or both;
``(ii) the conduct and support of studies, projects, and
research, which may include stipends, travel and other
support for personnel in collaboration with national and
international non-profit and for-profit organizations;
``(iii) the conduct and support of forums, meetings,
conferences, courses, and training workshops that may
include undergraduate, graduate, post-graduate, and post-
doctoral accredited courses and the maintenance of
accreditation of such courses by the Foundation at the State
and national level for college or continuing education
credits or for degrees;
``(iv) programs to support and encourage teachers and
students of science at all levels of education and programs
for the general public which promote the understanding of
science;
``(v) programs for writing, editing, printing,
publishing, and vending of books and other materials; and
``(vi) the conduct of other activities to carry out and
support the purpose described in subsection (b).
``(2) Fees.--The Foundation may assess fees for the provision of
professional, administrative and management services by the
Foundation in amounts determined reasonable and appropriate by the
Executive Director.
``(3) Authority of foundation.--The Foundation shall be the sole
entity responsible for carrying out the activities described in this
subsection.'';
(4) in subsection (d) (as so redesignated)--
(A) in paragraph (1)--
(i) by striking ``members of the Foundation'' in
subparagraph (A) and inserting ``appointed members of the
Board'';
(ii) by striking ``Council'' in subparagraph (B) and
inserting ``Board'';
(iii) by striking ``Council'' in subparagraph (C) and
inserting ``Board''; and
(iv) by adding at the end the following subparagraphs:
``(D)(i) Not later than 30 days after the date of the
enactment of the National Institutes of Health Revitalization
Act of 1993, the Director of the National Institutes of Health
shall convene a meeting of the ex officio members of the Board
to--
``(I) incorporate the Foundation and establish the
general policies of the Foundation for carrying out the
purposes of subsection (b), including the establishment of
the bylaws of the Foundation; and
``(II) appoint the members of the Board in accordance
with subparagraph (C).
``(ii) Upon the appointment of the members of the Board
under clause (i)(II), the terms of service of the ex officio
members of the Board as members of the Board shall terminate.
``(E) The agreement of not less than three-fifths of the
members of the ex officio members of the Board shall be required
for the appointment of each member to the initial Board.
``(F) No employee of the National Institutes of Health shall
be appointed as a member of the Board.
``(G) The Board may, through amendments to the bylaws of the
Foundation, provide that the number of members of the Board
shall be greater than the number specified in subparagraph
(C).'';
(B) in paragraph (2)--
(i) by striking ``The ex officio'' and inserting the
following:
``(A) The ex officio'';
(ii) by striking ``an appointed member of the Board to
serve as the Chair'' and inserting ``an individual to serve
as the initial Chair''; and
(iii) by adding at the end the following subparagraph:
``(B) Upon the termination of the term of service of the initial
Chair of the Board, the appointed members of the Board shall elect a
member of the Board to serve as the Chair of the Board.'';
(C) in paragraph (3)(A), by striking ``(2)(C)'' and
inserting ``(1)(C)''; and
(D) by adding at the end the following paragraphs:
``(5) Meetings and quorum.--A majority of the members of the
Board shall constitute a quorum for purposes of conducting the
business of the Board.
``(6) Certain bylaws.--
``(A) In establishing bylaws under this subsection, the
Board shall ensure that the following are provided for:
``(i) Policies for the selection of the officers,
employees, agents, and contractors of the Foundation.
``(ii) Policies, including ethical standards, for the
acceptance, solicitation, and disposition of donations and
grants to the Foundation and for the disposition of the
assets of the Foundation. Policies with respect to ethical
standards shall ensure that officers, employees and agents
of the Foundation (including members of the Board) avoid
encumbrances that would result in a conflict of interest,
including a financial conflict of interest or a divided
allegiance. Such policies shall include requirements for the
provision of information concerning any ownership or
controlling interest in entities related to the activities
of the Foundation by such officers, employees and agents and
their spouses and relatives.
``(iii) Policies for the conduct of the general
operations of the Foundation.
``(iv) Policies for writing, editing, printing,
publishing, and vending of books and other materials.
``(B) In establishing bylaws under this subsection, the
Board shall ensure that such bylaws (and activities carried out
under the bylaws) do not--
``(i) reflect unfavorably upon the ability of the
Foundation or the National Institutes of Health to carry out
its responsibilities or official duties in a fair and
objective manner; or
``(ii) compromise, or appear to compromise, the
integrity of any governmental agency or program, or any
officer or employee involved in such program.'';
(5) in subsection (i) (as so redesignated)--
(A) in paragraph (4), by inserting ``, and define the duties
of the officers and employees'' before the semicolon at the end;
(B) by striking paragraph (5);
(C) by redesignating paragraphs (6) through (14), as
paragraphs (5) through (13), respectively;
(D) in paragraph (7) (as so redesignated), by striking
``this subtitle'' and inserting ``this part'';
(E) by striking paragraph (8) (as so redesignated), and
inserting the following paragraph:
``(8) establish a process for the selection of candidates for
positions under subsection (c);''
(F) by inserting ``solicit'' after the paragraph designation
in paragraph (11) (as so redesignated);
(G) by striking ``and'' at the end of paragraph (13) (as so
redesignated);
(H) by inserting after paragraph (13) (as so redesignated),
the following paragraph:
``(14) enter into such other contracts, leases, cooperative
agreements, and other transactions as the Executive Director
considers appropriate to conduct the activities of the Foundation;
and''; and
(I) in paragraph (15), by striking ``this subtitle'' and
inserting ``this part'';
(6) by inserting after subsection (j) (as so redesignated), the
following subsections:
``(k) General Provisions.--
``(1) Foundation integrity.--The members of the Board shall be
accountable for the integrity of the operations of the Foundation
and shall ensure such integrity through the development and
enforcement of criteria and procedures relating to standards of
conduct (including those developed under subsection
(d)(2)(B)(i)(II)), financial disclosure statements, conflict of
interest rules, recusal and waiver rules, audits and other matter
determined appropriate by the Board.
``(2) Financial conflicts of interest.--Any individual who is an
officer, employee, or member of the Board of the Foundation may not
(in accordance with policies and requirements developed under
subsection (d)(2)(B)(i)(II)) personally or substantially participate
in the consideration or determination by the Foundation of any
matter that would directly or predictably affect any financial
interest of the individual or a relative (as such term is defined in
section 109(16) of the Ethics in Government Act of 1978) of the
individual, of any business organization or other entity, or of
which the individual is an officer or employee, or is negotiating
for employment, or in which the individual has any other financial
interest.
``(3) Audits; availability of records.--The Foundation shall--
``(A) provide for annual audits of the financial condition
of the Foundation; and
``(B) make such audits, and all other records, documents,
and other papers of the Foundation, available to the Secretary
and the Comptroller General of the United States for examination
or audit.
``(4) Reports.--
``(A) Not later than 5 months following the end of each
fiscal year, the Foundation shall publish a report describing
the activities of the Foundation during the preceding fiscal
year. Each such report shall include for the fiscal year
involved a comprehensive statement of the operations,
activities, financial condition, and accomplishments of the
Foundation.
``(B) With respect to the financial condition of the
Foundation, each report under subparagraph (A) shall include the
source, and a description of, all gifts or grants to the
Foundation of real or personal property, and the source and
amount of all gifts or grants to the Foundation of money. Each
such report shall include a specification of any restrictions on
the purposes for which gifts or grants to the Foundation may be
used.
``(C) The Foundation shall make copies of each report
submitted under subparagraph (A) available for public
inspection, and shall upon request provide a copy of the report
to any individual for a charge not exceeding the cost of
providing the copy.
``(D) The Board shall annually hold a public meeting to
summarize the activities of the Foundation and distribute
written reports concerning such activities and the scientific
results derived from such activities.
``(5) Service of federal employees.--Federal employees may serve
on committees advisory to the Foundation and otherwise cooperate
with and assist the Foundation in carrying out its function, so long
as the employees do not direct or control Foundation activities.
``(6) Relationship with existing entities.--The Foundation may,
pursuant to appropriate agreements, merge with, acquire, or use the
resources of existing nonprofit private corporations with missions
similar to the purposes of the Foundation, such as the Foundation
for Advanced Education in the Sciences.
``(7) Intellectual property rights.--The Board shall adopt
written standards with respect to the ownership of any intellectual
property rights derived from the collaborative efforts of the
Foundation prior to the commencement of such efforts.
``(8) National institutes of health amendments of 1990.--The
activities conducted in support of the National Institutes of Health
Amendments of 1990 (Public Law 101-613), and the amendments made by
such Act, shall not be nullified by the enactment of this section.
``(9) Limitation of activities.--The Foundation shall exist
solely as an entity to work in collaboration with the research
programs of the National Institutes of Health. The Foundation may
not undertake activities (such as the operation of independent
laboratories or competing for Federal research funds) that are
independent of those of the National Institutes of Health research
programs.
``(10) Transfer of funds.--The Foundation may not transfer funds
to the National Institutes of Health.
``(l) Duties of the Director.--
``(1) Applicability of certain standards to non-federal
employees.--In the case of any individual who is not an employee of
the Federal Government and who serves in association with the
National Institutes of Health, with respect to financial assistance
received from the Foundation, the Foundation may not provide the
assistance of, or otherwise permit the work at the National
Institutes of Health to begin until a memorandum of understanding
between the individual and the Director of the National Institutes
of Health, or the designee of such Director, has been executed
specifying that the individual shall be subject to such ethical and
procedural standards of conduct relating to duties performed at the
National Institutes of Health, as the Director of the National
Institutes of Health determines is appropriate.
``(2) Support services.--The Director of the National Institutes
of Health may provide facilities, utilities and support services to
the Foundation if it is determined by the Director to be
advantageous to the research programs of the National Institutes of
Health.'';
(7) in subsection (m) (as so redesignated), by amending the
subsection to read as follows:
``(m) Funding.--
``(1) Authorization of appropriations.--For the purpose of
carrying out this part, there is authorized to be appropriated an
aggregate $200,000 for the fiscal years 1994 and 1995.
``(2) Limitation regarding other funds.--Amounts appropriated
under any provision of law other than paragraph (1) may not be
expended to establish or operate the Foundation.''; and
(8) by adding at the end the following subsection:
``(n) Report on Adequacy of Compliance.--
``(1) In general.--With respect to the mission and function of
the Foundation, the Comptroller General of the United States shall
conduct an audit to determine--
``(A) whether the Foundation is in compliance with the
guidelines established under this section; and
``(B) whether the procedures utilized under this section are
adequate to prevent conflicts of interest involving the
Foundation, the employees of the Foundation or members of the
Board of the Foundation.
``(2) Report.--Not later than 18 months after the date on which
the Foundation is incorporated, the Comptroller General of the
United States shall complete the audit required under paragraph (1)
and prepare and submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Labor and Human
Resources of the Senate, a report describing the findings made with
respect to such audit.''.
TITLE XVIII--RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY
SYNDROME
Subtitle A--Office of AIDS Research
SEC. 1801. ESTABLISHMENT OF OFFICE.
(a) In General.--Part D of title XXIII of the Public Health Service
Act (42 U.S.C. 300cc-41 et seq.) is amended--
(1) by striking the part designation and the heading for the
part;
(2) by redesignating section 2351 as section 2354; and
(3) by inserting before section 2354 (as so redesignated) the
following:
``Part D--Office of AIDS Research
``Subpart I--Interagency Coordination of Activities
``SEC. 2351. ESTABLISHMENT OF OFFICE.
``(a) In General.--There is established within the National
Institutes of Health an office to be known as the Office of AIDS
Research. The Office shall be headed by a director, who shall be
appointed by the Secretary.
``(b) Duties.--
``(1) Interagency coordination of aids activities.--With respect
to acquired immune deficiency syndrome, the Director of the Office
shall plan, coordinate, and evaluate research and other activities
conducted or supported by the agencies of the National Institutes of
Health. In carrying out the preceding sentence, the Director of the
Office shall evaluate the AIDS activities of each of such agencies
and shall provide for the periodic reevaluation of such activities.
``(2) Consultations.--The Director of the Office shall carry out
this subpart (including developing and revising the plan required in
section 2353) in consultation with the heads of the agencies of the
National Institutes of Health, with the advisory councils of the
agencies, and with the advisory council established under section
2352.
``(3) Coordination.--The Director of the Office shall act as the
primary Federal official with responsibility for overseeing all AIDS
research conducted or supported by the National Institutes of
Health, and
``(A) shall serve to represent the National Institutes of
Health AIDS Research Program at all relevant Executive branch
task forces and committees; and
``(B) shall maintain communications with all relevant Public
Health Service agencies and with various other departments of
the Federal Government, to ensure the timely transmission of
information concerning advances in AIDS research and the
clinical treatment of acquired immune deficiency syndrome and
its related conditions, between these various agencies for
dissemination to affected communities and health care providers.
``SEC. 2352. ADVISORY COUNCIL; COORDINATING COMMITTEES.
``(a) Advisory Council.--
``(1) In general.--The Secretary shall establish an advisory
council for the purpose of providing advice to the Director of the
Office on carrying out this part. (Such council is referred to in
this subsection as the `Advisory Council'.)
``(2) Composition, compensation, terms, chair, etc.--Subsections
(b) through (g) of section 406 apply to the Advisory Council to the
same extent and in the same manner as such subsections apply to
advisory councils for the national research institutes, except
that--
``(A) in addition to the ex officio members specified in
section 406(b)(2), there shall serve as such members of the
Advisory Council a representative from the advisory council of
each of the National Cancer Institute and the National Institute
on Allergy and Infectious Diseases; and
``(B) with respect to the other national research
institutes, there shall serve as ex officio members of such
Council, in addition to such members specified in subparagraph
(A), a representative from the advisory council of each of the 2
institutes that receive the greatest funding for AIDS
activities.
``(b) Individual Coordinating Committees Regarding Research
Disciplines.--
``(1) In general.--The Director of the Office shall establish,
for each research discipline in which any activity under the plan
required in section 2353 is carried out, a committee for the purpose
of providing advice to the Director of the Office on carrying out
this part with respect to such discipline. (Each such committee is
referred to in this subsection as a `coordinating committee'.)
``(2) Composition.--Each coordinating committee shall be
composed of representatives of the agencies of the National
Institutes of Health with significant responsibilities regarding the
research discipline involved.
``SEC. 2353. COMPREHENSIVE PLAN FOR EXPENDITURE OF APPROPRIATIONS.
``(a) In General.--Subject to the provisions of this section and
other applicable law, the Director of the Office, in carrying out
section 2351, shall--
``(1) establish a comprehensive plan for the conduct and support
of all AIDS activities of the agencies of the National Institutes of
Health (which plan shall be first established under this paragraph
not later than 12 months after the date of the enactment of the
National Institutes of Health Revitalization Act of 1993);
``(2) ensure that the Plan establishes priorities among the AIDS
activities that such agencies are authorized to carry out;
``(3) ensure that the Plan establishes objectives regarding such
activities, describes the means for achieving the objectives, and
designates the date by which the objectives are expected to be
achieved;
``(4) ensure that all amounts appropriated for such activities
are expended in accordance with the Plan;
``(5) review the Plan not less than annually, and revise the
Plan as appropriate; and
``(6) ensure that the Plan serves as a broad, binding statement
of policies regarding AIDS activities of the agencies, but does not
remove the responsibility of the heads of the agencies for the
approval of specific programs or projects, or for other details of
the daily administration of such activities, in accordance with the
Plan.
``(b) Certain Components of Plan.--With respect to AIDS activities
of the agencies of the National Institutes of Health, the Director of
the Office shall ensure that the Plan--
``(1) provides for basic research;
``(2) provides for applied research;
``(3) provides for research that is conducted by the agencies;
``(4) provides for research that is supported by the agencies;
``(5) provides for proposals developed pursuant to solicitations
by the agencies and for proposals developed independently of such
solicitations; and
``(6) provides for behavioral research and social sciences
research.
``(c) Budget Estimates.--
``(1) Full-funding budget.--
``(A) With respect to a fiscal year, the Director of the
Office shall prepare and submit directly to the President, for
review and transmittal to the Congress, a budget estimate for
carrying out the Plan for the fiscal year, after reasonable
opportunity for comment (but without change) by the Secretary,
the Director of the National Institutes of Health, and the
advisory council established under section 2352. The budget
estimate shall include an estimate of the number and type of
personnel needs for the Office.
``(B) The budget estimate submitted under subparagraph (A)
shall estimate the amounts necessary for the agencies of the
National Institutes of Health to carry out all AIDS activities
determined by the Director of the Office to be appropriate,
without regard to the probability that such amounts will be
appropriated.
``(2) Alternative budgets.--
``(A) With respect to a fiscal year, the Director of the
Office shall prepare and submit to the Secretary and the
Director of the National Institutes of Health the budget
estimates described in subparagraph (B) for carrying out the
Plan for the fiscal year. The Secretary and such Director shall
consider each of such estimates in making recommendations to the
President regarding a budget for the Plan for such year.
``(B) With respect to the fiscal year involved, the budget
estimates referred to in subparagraph (A) for the Plan are as
follows:
``(i) The budget estimate submitted under paragraph (1).
``(ii) A budget estimate developed on the assumption
that the amounts appropriated will be sufficient only for--
``(I) continuing the conduct by the agencies of the
National Institutes of Health of existing AIDS
activities (if approved for continuation), and
continuing the support of such activities by the
agencies in the case of projects or programs for which
the agencies have made a commitment of continued
support; and
``(II) carrying out, of activities that are in
addition to activities specified in subclause (I), only
such activities for which the Director determines there
is the most substantial need.
``(iii) Such other budget estimates as the Director of
the Office determines to be appropriate.
``(d) Funding.--
``(1) Authorization of appropriations.--For the purpose of
carrying out AIDS activities under the Plan, there are authorized to
be appropriated such sums as may be necessary for each of the fiscal
years 1994 through 1996.
``(2) Receipt of funds.--For the first fiscal year beginning
after the date on which the Plan first established under section
2353(a)(1) has been in effect for 12 months, and for each subsequent
fiscal year, the Director of the Office shall receive directly from
the President and the Director of the Office of Management and
Budget all funds available for AIDS activities of the National
Institutes of Health.
``(3) Allocations for agencies.--
``(A) Each fiscal year the Director of the Office shall,
from the amounts received under paragraph (2) for the fiscal
year, allocate to the agencies of the National Institutes of
Health (in accordance with the Plan) all amounts available for
such year for carrying out the AIDS activities specified in
subsection (c)(2)(B)(ii)(I) for such year. Such allocation
shall, to the extent practicable, be made not later than 15 days
after the date on which the Director receives amounts under
paragraph (2).
``(B) Each fiscal year the Director of the Office shall,
from the amounts received under paragraph (2) for the fiscal
year, allocate to the agencies of the National Institutes of
Health (in accordance with the Plan) all amounts available for
such year for carrying out AIDS activities that are not referred
to in subparagraph (A). Such allocation shall, to the extent
practicable, be made not later than 30 days after the date on
which the Director receives amounts under paragraph (2).''.
(b) Conforming Amendments.--Section 2354 of the Public Health
Service Act, as redesignated by subsection (a)(2) of this section, is
amended--
(1) in the heading for the section, by striking ``ESTABLISHMENT
OF'' and inserting ``ADDITIONAL'';
(2) in subsection (a)--
(A) in the matter preceding paragraph (1), by striking ``In
carrying out'' and all that follows and inserting the following:
``In carrying out AIDS research, the Director of the Office--'';
(B) by striking paragraphs (1) and (2) and redesignating
paragraphs (3) through (8) as paragraphs (1) through (6);
(C) in paragraph (3) (as so redesignated), by striking
``may'' and all that follows in the matter preceding
subparagraph (A) and inserting the following: ``may support--'';
(D) in paragraph (5) (as so redesignated)--
(i) in subparagraph (A)--
``(I) by striking ``may'' and all that follows
through ``acquire,'' and inserting ``may acquire,''; and
``(II) by striking ``Director'' and all that follows
through ``determines'' and inserting ``Director of the
Office determines'';
(ii) in subparagraph (B), by striking ``may'' and all
that follows through ``make grants'' and inserting ``may
make grants''; and
(iii) in subparagraph (C), by striking ``may'' and all
that follows through ``acquire,'' and inserting ``may
acquire,''; and
(E) in each of paragraphs (2), (3)(A), and (4) (as so
redesignated), by striking ``research relating to acquired
immune deficiency syndrome'' and inserting ``AIDS research'';
(3) in subsection (b), in the matter preceding paragraph (1), by
striking ``The Director'' and all that follows through ``shall'' and
inserting ``The Director of the Office shall''; and
(4) in subsection (c), by striking ``the Director'' and all that
follows through ``shall'' and inserting ``the Director of the Office
shall''.
SEC. 1802. ESTABLISHMENT OF EMERGENCY DISCRETIONARY FUND.
Part D of title XXIII of the Public Health Service Act, as amended
by section 1801 of this Act, is amended by adding at the end the
following subpart:
``Subpart II--Emergency Discretionary Fund
``SEC. 2356. EMERGENCY DISCRETIONARY FUND.
``(a) In General.--
``(1) Establishment.--There is established a fund consisting of
such amounts as may be appropriated under subsection (g). Subject to
the provisions of this section, the Director of the Office, after
consultation with the advisory council established under section
2352, may expend amounts in the Fund for the purpose of conducting
and supporting such AIDS activities, including projects of AIDS
research, as may be authorized in this Act for the National
Institutes of Health.
``(2) Preconditions to use of fund.--Amounts in the Fund may be
expended only if--
``(A) the Director identifies the particular set of AIDS
activities for which such amounts are to be expended;
``(B) the set of activities so identified constitutes either
a new project or additional AIDS activities for an existing
project;
``(C) the Director of the Office has made a determination
that there is a significant need for such set of activities; and
``(D) as of June 30 of the fiscal year preceding the fiscal
year in which the determination is made, such need was not
provided for in any appropriations Act passed by the House of
Representatives to make appropriations for the Departments of
Labor, Health and Human Services (including the National
Institutes of Health), Education, and related agencies for the
fiscal year in which the determination is made.
``(3) Two-year use of fund for project involved.--In the case of
an identified set of AIDS activities, obligations of amounts in the
Fund may not be made for such set of activities after the expiration
of the 2-year period beginning on the date on which the initial
obligation of such amounts is made for such set.
``(b) Peer Review.--With respect to an identified set of AIDS
activities carried out with amounts in the Fund, this section may not be
construed as waiving applicable requirements for peer review.
``(c) Limitations on Use of Fund.--
``(1) Construction of facilities.--Amounts in the Fund may not
be used for the construction, renovation, or relocation of
facilities, or for the acquisition of land.
``(2) Congressional disapproval of projects.--
``(A) Amounts in the Fund may not be expended for the fiscal
year involved for an identified set of AIDS activities, or a
category of AIDS activities, for which--
``(i)(I) amounts were made available in an
appropriations Act for the preceding fiscal year; and
``(II) amounts are not made available in any
appropriations Act for the fiscal year involved; or
``(ii) amounts are by law prohibited from being
expended.
``(B) A determination under subparagraph (A)(i) of whether
amounts have been made available in appropriations Acts for a
fiscal year shall be made without regard to whether such Acts
make available amounts for the Fund.
``(3) Investment of fund amounts.--Amounts in the Fund may not
be invested.
``(d) Applicability of Limitation Regarding Number of Employees.--
The purposes for which amounts in the Fund may be expended include the
employment of individuals necessary to carry out identified sets of AIDS
activities approved under subsection (a). Any individual employed under
the preceding sentence may not be included in any determination of the
number of full-time equivalent employees for the Department of Health
and Human Services for the purpose of any limitation on the number of
such employees established by law prior to, on, or after the date of the
enactment of the National Institutes of Health Revitalization Act of
1993.
``(e) Report to Congress.--Not later than February 1 of each fiscal
year, the Director of the Office shall submit to the Committee on Energy
and Commerce of the House of Representatives, and to the Committee on
Labor and Human Resources of the Senate, a report on the identified sets
of AIDS activities carried out during the preceding fiscal year with
amounts in the Fund. The report shall provide a description of each such
set of activities and an explanation of the reasons underlying the use
of the Fund for the set.
``(f) Definitions.--For purposes of this section:
``(1) The term `Fund' means the fund established in subsection
(a).
``(2) The term `identified set of AIDS activities' means a
particular set of AIDS activities identified under subsection
(a)(2)(A).
``(g) Funding.--
``(1) Authorization of appropriations.--For the purpose of
providing amounts for the Fund, there is authorized to be
appropriated $100,000,000 for each of the fiscal years 1994 through
1996.
``(2) Availability.--Amounts appropriated for the Fund are
available until expended.''.
SEC. 1803. GENERAL PROVISIONS.
Part D of title XXIII of the Public Health Service Act, as amended
by section 1802 of this Act, is amended by adding at the end the
following subpart:
``Subpart III--General Provisions
``SEC. 2359. GENERAL PROVISIONS REGARDING THE OFFICE.
``(a) Administrative Support for Office.--The Secretary, acting
through the Director of the National Institutes of Health, shall provide
administrative support and support services to the Director of the
Office and shall ensure that such support takes maximum advantage of
existing administrative structures at the agencies of the National
Institutes of Health.
``(b) Evaluation and Report.--
``(1) Evaluation.--Not later than 5 years after the date of the
enactment of National Institutes of Health Revitalization Act of
1993, the Secretary shall conduct an evaluation to--
``(A) determine the effect of this section on the planning
and coordination of the AIDS research programs at the
institutes, centers and divisions of the National Institutes of
Health;
``(B) evaluate the extent to which this part has eliminated
the duplication of administrative resources among such
Institutes, centers and divisions; and
``(C) provide recommendations concerning future alterations
with respect to this part.
``(2) Report.--Not later than 1 year after the date on which the
evaluation is commenced under paragraph (1), the Secretary shall
prepare and submit to the Committee on Labor and Human Resources of
the Senate, and the Committee on Energy and Commerce of the House of
Representatives, a report concerning the results of such evaluation.
``(c) Definitions.--For purposes of this part:
``(1) The term `AIDS activities' means AIDS research and other
activities that relate to acquired immune deficiency syndrome.
``(2) The term `AIDS research' means research with respect to
acquired immune deficiency syndrome.
``(3) The term `Office' means the Office of AIDS Research.
``(4) The term `Plan' means the plan required in section
2353(a)(1).''.
Subtitle B--Certain Programs
SEC. 1811. REVISION AND EXTENSION OF CERTAIN PROGRAMS.
Title XXIII of the Public Health Service Act (42 U.S.C. 300cc et
seq.) is amended--
(1) in section 2304(c)(1)--
(A) in the matter preceding subparagraph (A), by inserting
after ``Director of such Institute'' the following: ``(and may
provide advice to the Directors of other agencies of the
National Institutes of Health, as appropriate)''; and
(B) in subparagraph (A), by inserting before the semicolon
the following: ``, including recommendations on the projects of
research with respect to diagnosing immune deficiency and with
respect to predicting, diagnosing, preventing, and treating
opportunistic cancers and infectious diseases'';
(2) in section 2311(a)(1), by inserting before the semicolon the
following: ``, including evaluations of methods of diagnosing immune
deficiency and evaluations of methods of predicting, diagnosing,
preventing, and treating opportunistic cancers and infectious
diseases'';
(3) in section 2315--
(A) in subsection (a)(2), by striking ``international
research'' and all that follows and inserting ``international
research and training concerning the natural history and
pathogenesis of the human immunodeficiency virus and the
development and evaluation of vaccines and treatments for
acquired immune deficiency syndrome and opportunistic
infections.''; and
(B) in subsection (f), by striking ``there are authorized''
and all that follows and inserting ``there are authorized to be
appropriated such sums as may be necessary for each fiscal
year.'';
(4) in section 2318--
(A) in subsection (a)(1)--
(i) by inserting after ``The Secretary'' the following:
``, acting through the Director of the National Institutes
of Health and after consultation with the Administrator for
Health Care Policy and Research,''; and
(ii) by striking ``syndrome'' and inserting ``syndrome,
including treatment and prevention of HIV infection and
related conditions among women''; and
(B) in subsection (e), by striking ``1991.'' and inserting
the following: ``1991, and such sums as may be necessary for
each of the fiscal years 1994 through 1996.'';
(5) in section 2320(b)(1)(A), by striking ``syndrome'' and
inserting ``syndrome and the natural history of such infection'';
(6) in section 2320(e)(1), by striking ``there are authorized''
and all that follows and inserting ``there are authorized to be
appropriated such sums as may be necessary for each fiscal year.'';
(7) in section 2341(d), by striking ``there are authorized'' and
all that follows and inserting ``there are authorized to be
appropriated such sums as may be necessary for each fiscal year.'';
and
(8) in section 2361, by striking ``For purposes'' and all that
follows and inserting the following:
``For purposes of this title:
``(1) The term `infection', with respect to the etiologic agent
for acquired immune deficiency syndrome, includes opportunistic
cancers and infectious diseases and any other conditions arising
from infection with such etiologic agent.
``(2) The term `treatment', with respect to the etiologic agent
for acquired immune deficiency syndrome, includes primary and
secondary prophylaxis.''.
TITLE XIX--STUDIES
SEC. 1901. LIFE-THREATENING ILLNESSES.
(a) Third-Party Payments Regarding Certain Clinical Trials and
Certain Life-Threatening Illnesses.--The Secretary of Health and Human
Services, acting through the Director of the National Institutes of
Health, shall conduct a study for the purpose of--
(1) determining the policies of third-party payors regarding the
payment of the costs of appropriate health services that are
provided incident to the participation of individuals as subjects in
clinical trials conducted in the development of drugs with respect
to acquired immune deficiency syndrome, cancer, and other life-
threatening illnesses; and
(2) developing recommendations regarding such policies.
(b) Vaccines for Human Immunodeficiency Virus.--
(1) In general.--The Secretary of Health and Human Services,
acting through the National Institutes of Health, shall develop a
plan for the appropriate inclusion of HIV-infected women, including
pregnant women, HIV-infected infants, and HIV-infected children in
studies conducted by or through the National Institutes of Health
concerning the safety and efficacy of HIV vaccines for the treatment
and prevention of HIV infection. Such plan shall ensure the full
participation of other Federal agencies currently conducting HIV
vaccine studies and require that such studies conform fully to the
requirements of part 46 of title 45, Code of Federal Regulations.
(2) Report.--Not later than 180 days after the date of the
enactment of this Act, the Secretary of Health and Human Services
shall prepare and submit to the Committee on Energy and Commerce of
the House of Representatives, and the Committee on Labor and Human
Resources of the Senate, a report concerning the plan developed
under paragraph (1).
(3) Implementation.--Not later than 12 months after the date of
the enactment of this Act, the Secretary of Health and Human
Services shall implement the plan developed under paragraph (1),
including measures for the full participation of other Federal
agencies currently conducting HIV vaccine studies.
(4) Authorization of appropriations.--For the purpose of
carrying out this subsection, there are authorized to be
appropriated such sums as may be necessary for each of the fiscal
years 1994 through 1996.
SEC. 1902. MALNUTRITION IN THE ELDERLY.
(a) Study.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), acting through
the National Institute on Aging, coordinating with the Agency for
Health Care Policy and Research and, to the degree possible, in
consultation with the head of the National Nutrition Monitoring and
Related Research Program established by section 5311(a) of Public
Law 101-445 (7 U.S.C. 5301 et seq.), shall conduct a 3-year
nutrition screening and intervention activities study of the
elderly.
(2) Efficacy and cost-effectiveness of nutrition screening and
intervention activities.--In conducting the study, the Secretary
shall determine the efficacy and cost-effectiveness of nutrition
screening and intervention activities conducted in the elderly
health and long-term care continuum, and of a program that would
institutionalize nutrition screening and intervention activities. In
evaluating such a program, the Secretary shall determine--
(A) if health or quality of life is measurably improved for
elderly individuals who receive routine nutritional screening
and treatment;
(B) if federally subsidized home or institutional care is
reduced because of increased independence of elderly individuals
resulting from improved nutritional status;
(C) if a multidisciplinary approach to nutritional care is
effective in addressing the nutritional needs of elderly
individuals; and
(D) if reimbursement for nutrition screening and
intervention activities is a cost-effective approach to
improving the health status of elderly individuals.
(3) Populations.--The populations of elderly individuals in
which the study will be conducted shall include populations of
elderly individuals who are--
(A) living independently, including--
(i) individuals who receive home and community-based
services or family support;
(ii) individuals who do not receive additional services
and support;
(iii) individuals with low incomes; and
(iv) individuals who are minorities;
(B) hospitalized, including individuals admitted from home
and from institutions; and
(C) institutionalized in residential facilities such as
nursing homes and adult homes.
(b) Malnutrition Study.--The Secretary, acting through the National
Institute on Aging, shall conduct a 3-year study to determine the extent
of malnutrition in elderly individuals in hospitals and long-term care
facilities and in elderly individuals who are living independently.
(c) Report.--The Secretary shall submit a report to the Committee on
Labor and Human Resources of the Senate and the Committee on Energy and
Commerce of the House of Representatives containing the findings
resulting from the studies described in subsections (a) and (b),
including a determination regarding whether a program that would
institutionalize nutrition screening and intervention activities should
be adopted, and the rationale for the determination.
(d) Advisory Panel.--
(1) Establishment.--The Secretary, acting through the Director
of the National Institute on Aging, shall establish an advisory
panel that shall oversee the design, implementation, and evaluation
of the studies described in subsections (a) and (b).
(2) Composition.--The advisory panel shall include
representatives appointed for the life of the panel by the Secretary
from the Health Care Financing Administration, the Social Security
Administration, the National Center for Health Statistics, the
Administration on Aging, the National Council on the Aging, the
American Dietetic Association, the American Academy of Family
Physicians, and such other agencies or organizations as the
Secretary determines to be appropriate.
(3) Compensation and expenses.--
(A) Compensation.--Each member of the advisory panel who is
not an employee of the Federal Government shall receive
compensation for each day engaged in carrying out the duties of
the panel, including time engaged in traveling for purposes of
such duties. Such compensation may not be provided in an amount
in excess of the maximum rate of basic pay payable for GS-18 of
the General Schedule.
(B) Travel expenses.--Each member of the advisory panel
shall receive travel expenses, including per diem in lieu of
subsistence, at rates authorized for employees of agencies under
subchapter I of chapter 57 of title 5, United States Code, for
each day the member is engaged in the performance of duties away
from the home or regular place of business of the member.
(4) Detail of federal employees.--On the request of the
advisory panel, the head of any Federal agency shall detail, without
reimbursement, any of the personnel of the agency to the advisory
panel to assist the advisory panel in carrying out its duties. Any
detail shall not interrupt or otherwise affect the civil service
status or privileges of the Federal employee.
(5) Technical assistance.--On the request of the advisory
panel, the head of a Federal agency shall provide such technical
assistance to the advisory panel as the advisory panel determines to
be necessary to carry out its duties.
(6) Termination.--Notwithstanding section 15 of the Federal
Advisory Committee Act (5 U.S.C. App.), the advisory panel shall
terminate 3 years after the date of enactment of this Act.
SEC. 1903. RESEARCH ACTIVITIES ON CHRONIC FATIGUE SYNDROME.
The Secretary of Health and Human Services shall, not later than
October 1, 1993, and annually thereafter for the next 3 years, prepare
and submit to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Labor and Human Resources of the
Senate, a report that summarizes the research activities conducted or
supported by the National Institutes of Health concerning chronic
fatigue syndrome. Such report should include information concerning
grants made, cooperative agreements or contracts entered into,
intramural activities, research priorities and needs, and a plan to
address such priorities and needs.
SEC. 1904. REPORT ON MEDICAL USES OF BIOLOGICAL AGENTS IN DEVELOPMENT OF
DEFENSES AGAINST BIOLOGICAL WARFARE.
The Secretary of Health and Human Services, in consultation with the
Secretary of Defense and with the heads of other appropriate executive
agencies, shall report to the House Energy and Commerce Committee and
the Senate Labor and Human Resources Committee on the appropriateness
and impact of the National Institutes of Health assuming responsibility
for the conduct of all Federal research, development, testing, and
evaluation functions relating to medical countermeasures against
biowarfare threat agents. In preparing the report, the Secretary of
Health and Human Services shall identify the extent to which such
activities are carried out by agencies other than the National
Institutes of Health, and assess the impact (positive and negative) of
the National Institutes of Health assuming responsibility for such
activities, including the impact under the Budget Enforcement Act and
the Omnibus Budget Reconciliation Act of 1990 on existing National
Institutes of Health research programs as well as other programs within
the category of domestic discretionary spending. Such Secretary shall
submit the report not later than 12 months after the date of the
enactment of this Act. The Secretary shall provide a copy of the report
to the House and Senate Committees on Armed Services.
SEC. 1905. PERSONNEL STUDY OF RECRUITMENT, RETENTION AND TURNOVER.
(a) Study of Personnel System.--Not later than 1 year after the date
of the enactment of this Act, the Secretary of Health and Human
Services, acting through the Director of the National Institutes of
Health, shall conduct a study to review the retention, recruitment,
vacancy and turnover rates of support staff, including firefighters, law
enforcement, procurement officers, technicians, nurses and clerical
employees, to ensure that the National Institutes of Health is
adequately supporting the conduct of efficient, effective and high
quality research for the American public. The Director of NIH shall work
in conjunction with appropriate employee organizations and
representatives in developing such a study.
(b) Submission to Congress.--Not later than 1 year after the date of
the enactment of this Act, the Secretary of Health and Human Services
shall prepare and submit to the Committee on Energy and Commerce of the
House of Representatives, and to the Committee on Labor and Human
Resources of the Senate, a report containing the study conducted under
subsection (a) together with the recommendations of the Secretary
concerning the enactment of legislation to implement the results of such
study.
SEC. 1906. PROCUREMENT.
(a) In General.--The Director of the National Institutes of Health
and the Administrator of the General Services Administration shall
jointly conduct a study to develop a streamlined procurement system for
the National Institutes of Health that complies with the requirements of
Federal law.
(b) Report.--Not later than March 1, 1994, the officials specified
in subsection (a) shall complete the study required in such subsection
and shall submit to the Committee on Energy and Commerce of the House of
Representatives, and the Committee on Labor and Human Resources of the
Senate, a report describing the findings made as a result of the study.
SEC. 1907. CHRONIC PAIN CONDITIONS.
(a) In General.--The Director of the National Institutes of Health
(in this section referred to as the `Director'), acting through the
Director of the National Institute of Dental Research and as appropriate
through the heads of other agencies of such Institutes, shall conduct a
study for the purpose of determining the incidence in the United States
of cases of chronic pain (including chronic pain resulting from back
injuries) and the effect of such cases on the costs of health care in
the United States.
(b) Certain Elements of Study.--The cases of chronic pain with
respect to which the study required in subsection (a) is conducted shall
include reflex sympathetic dystrophy syndrome, temporomandibular joint
disorder, post-herpetic neuropathy, painful diabetic neuropathy, phantom
pain, and post-stroke pain.
(c) Report.--Not later than 2 years after the date of the enactment
of this Act, the Director shall complete the study required in
subsection (a) and submit to the Committee on Energy and Commerce of the
House of Representatives, and to the Committee on Labor and Human
Resources of the Senate, a report describing the findings made as a
result of the study.
SEC. 1908. RELATIONSHIP BETWEEN THE CONSUMPTION OF LEGAL AND ILLEGAL
DRUGS.
(a) In General.--The Secretary of Health and Human Services shall
review and consider all existing relevant data and research concerning
whether there is a relationship between an individual's receptivity to
use or consume legal drugs and the consumption or abuse by the
individual of illegal drugs. On the basis of such review, the Secretary
shall determine whether additional research is necessary. If the
Secretary determines additional research is required, the Secretary
shall conduct a study of those subjects where the Secretary's review
indicates additional research is needed, including, if necessary, a
review of--
(1) the effect of advertising and marketing campaigns that
promote the use of legal drugs on the public;
(2) the correlation of legal drug abuse with illegal drug abuse;
and
(3) other matters that the Secretary determines appropriate.
(b) Report.--Not later than 12 months after the date of enactment of
this Act, the Secretary shall prepare and submit, to the Committee on
Energy and Commerce of the House of Representatives and Committee on
Labor and Human Resources of the Senate, a report containing the results
of the review conducted under subsection (b). If the Secretary
determines additional research is required, no later than 2 years after
the date of enactment of this Act, the Secretary shall prepare and
submit, to the Committee on Energy and Commerce of the House of
Representatives and Committee on Labor and Human Resources of the
Senate, a report containing the results of the additional research
conducted under subsection (b).
SEC. 1909. REDUCING ADMINISTRATIVE HEALTH CARE COSTS.
The Secretary of Health and Human Services, acting through the
Agency for Health Care Policy and Research and, to the extent possible,
in consultation with the Health Care Financing Administration, may fund
research to develop a text-based standardized billing process, through
the utilization of text-based information retrieval and natural language
processing techniques applied to automatic coding and analysis of
textual patient discharge summaries and other text-based electronic
medical records, within a parallel general purpose (shared memory) high
performance computing environment. The Secretary shall determine whether
such a standardized approach to medical billing, through the utilization
of the text-based hospital discharge summary as well as electronic
patient records can reduce the administrative billing costs of health
care delivery.
SEC. 1910. SENTINEL DISEASE CONCEPT STUDY.
(a) In General.--The Secretary of Health and Human Services, in
cooperation with the Agency for Toxic Substances and Disease Registry
and the Centers for Disease Control and Prevention, shall design and
implement a pilot sentinel disease surveillance system, and as
appropriate, a follow-up system.
(b) Purpose.--The purpose of the study conducted under subsection
(a) shall be to determine the applicability of and the difficulties
associated with the implementation of the sentinel disease concept for
identifying the relationship between the occupation of household members
and the incidence of subsequent conditions or diseases in other members
of the household.
(c) Report.--Not later than 4 years after the date of enactment of
this Act, the Director of the National Institutes of Health shall
prepare and submit to the appropriate committees of Congress, a report
concerning the results of the study conducted under subsection (a).
SEC. 1911. POTENTIAL ENVIRONMENTAL AND OTHER RISKS CONTRIBUTING TO
INCIDENCE OF BREAST CANCER.
(a) Requirement of Study.--
(1) In general.--The Director of the National Cancer Institute
(in this section referred to as the ``Director''), in collaboration
with the Director of the National Institute of Environmental Health
Sciences, shall conduct a case-control study to assess biological
markers of environmental and other potential risk factors
contributing to the incidence of breast cancer in--
(A) the Counties of Nassau and Suffolk, in the State of New
York; and
(B) the 2 counties in the northeastern United States that,
as identified in the report specified in paragraph (2), had the
highest age-adjusted mortality rate of such cancer that
reflected not less than 30 deaths during the 5-year period for
which findings are made in the report.
(2) Relevant report.--The report referred to in paragraph (1)(B)
is the report of the findings made in the study entitled ``Survival,
Epidemiology, and End Results'', relating to cases of cancer during
the years 1983 through 1987.
(b) Certain Elements of Study.--Activities of the Director in
carrying out the study under subsection (a) shall include the use of a
geographic system to evaluate the current and past exposure of
individuals, including direct monitoring and cumulative estimates of
exposure, to--
(1) contaminated drinking water;
(2) sources of indoor and ambient air pollution, including
emissions from aircraft;
(3) electromagnetic fields;
(4) pesticides and other toxic chemicals;
(5) hazardous and municipal waste; and
(6) such other factors as the Director determines to be
appropriate.
(c) Report.--Not later than 30 months after the date of the
enactment of this Act, the Director shall complete the study required in
subsection (a) and submit to the Committee on Energy and Commerce of the
House of Representatives, and to the Committee on Labor and Human
Resources of the Senate, a report describing the findings made as a
result of the study.
(d) Funding.--Of the amounts appropriated for fiscal years 1994 and
1995 for the National Institute of Environmental Health Sciences and the
National Cancer Institute, the Director of the National Institutes of
Health shall make available amounts for carrying out the study required
in subsection (a).
SEC. 1912. SUPPORT FOR BIOENGINEERING RESEARCH.
(a) Study.--The Secretary of Health and Human Services, acting
through the Director of the National Institutes of Health, shall conduct
a study for the purpose of--
(1) determining the sources and amounts of public and private
funding devoted to basic research in bioengineering, including
biomaterials sciences, cellular bioprocessing, tissue and
rehabilitation engineering;
(2) evaluating whether that commitment is sufficient to maintain
the innovative edge that the United States has in these
technologies;
(3) evaluating the role of the National Institutes of Health or
any other Federal agency to achieve a greater commitment to
innovation in bioengineering; and
(4) evaluating the need for better coordination and
collaboration among Federal agencies and between the public and
private sectors.
In conducting such study, the Director shall work in conjunction with
appropriate organizations and representatives including academics,
industry leaders, bioengineering societies, and public agencies.
(b) Report.--Not later than 1 year after the date of enactment of
this Act, the Secretary of Health and Human Services shall prepare and
submit to the Committee on Labor and Human Resources of the Senate, and
the Committee on Energy and Commerce of the House of Representatives, a
report containing the findings of the study conducted under subsection
(a) together with recommendations concerning the enactment of
legislation to implement the results of such study.
SEC. 1913. COST OF CARE IN LAST 6 MONTHS OF LIFE.
(a) Study.--
(1) In general.--The Secretary of Health and Human Services (in
this section referred to as the ``Secretary''), acting through the
Agency for Health Care Policy and Research and, to the degree
possible, in consultation with the Health Care Financing
Administration, shall conduct a study, using the most recent
National Medical Expenditure Survey database, to estimate the
average amount of health care expenditures incurred during the last
6 months of life by--
(A) the population of individuals who are 65 years of age
and older; and
(B) the total population, broken down based on
noninstitutionalized and institutionalized populations.
(2) Elements of study.--The study conducted under paragraph (1)
shall--
(A) be designed in a manner that will produce estimates of
health care costs expended for health care provided to
individuals during the last 6 months of life;
(B) be designed to produce estimates of such costs for the
populations identified in subparagraphs (A) and (B) of paragraph
(1);
(C) include a calculation of the estimated amount of total
health care expenditures during such periods of time; and
(D) include a calculation of the estimate described in
subparagraph (C)--
(i) as a percentage of the total national health care
expenditures; and
(ii) for those age 65 years and over, as a percentage of
the total Medicare expenditures for those age 65 years and
over.
(b) Report.--Not later than 6 months after the date of the enactment
of this Act, the Secretary shall prepare and submit to the Committee on
Labor and Human Resources of the Senate and the Committee on Energy and
Commerce of the House of Representatives, a report containing the
findings resulting from the study described in subsection (a).
(c) 1996 National Medical Expenditure Survey.--
(1) In general.--The Secretary, acting through the Agency for
Health Care Policy and Research, shall ensure that the 1996 National
Medical Expenditure Survey is designed in a manner that will produce
an estimate of the amount expended for health care provided to
individuals during the last 6 months of life.
(2) Populations.--In designing the Survey under paragraph (1),
the Secretary shall ensure that such Survey produces the data
required under such paragraph for the population of individuals who
are 65 years of age or older, broken down based on
noninstitutionalized and institutionalized populations.
TITLE XX--MISCELLANEOUS PROVISIONS
SEC. 2001. DESIGNATION OF SENIOR BIOMEDICAL RESEARCH SERVICE IN HONOR OF
SILVIO O. CONTE; LIMITATION ON NUMBER OF MEMBERS.
(a) In General.--Section 228(a) of the Public Health Service Act (42
U.S.C. 237(a)), as added by section 304 of Public Law 101-509, is
amended to read as follows:
``(a)(1) There shall be in the Public Health Service a Silvio O.
Conte Senior Biomedical Research Service, not to exceed 500 members.
``(2) The authority established in paragraph (1) regarding the
number of members in the Silvio O. Conte Senior Biomedical Research
Service is in addition to any authority established regarding the number
of members in the commissioned Regular Corps, in the Reserve Corps, and
in the Senior Executive Service. Such paragraph may not be construed to
require that the number of members in the commissioned Regular Corps, in
the Reserve Corps, or in the Senior Executive Service be reduced to
offset the number of members serving in the Silvio O. Conte Senior
Biomedical Research Service (in this section referred to as the
`Service').''.
(b) Conforming Amendment.--Section 228 of the Public Health Service
Act (42 U.S.C. 237), as added by section 304 of Public Law 101-509, is
amended in the heading for the section by amending the heading to read
as follows:
``silvio o. conte senior biomedical research service''.
SEC. 2002. MASTER PLAN FOR PHYSICAL INFRASTRUCTURE FOR RESEARCH.
Not later than June 1, 1994, the Secretary of Health and Human
Services, acting through the Director of the National Institutes of
Health, shall present to the Congress a master plan to provide for the
replacement or refurbishment of less than adequate buildings, utility
equipment and distribution systems (including the resources that provide
electrical and other utilities, chilled water, air handling, and other
services that the Secretary, acting through the Director, deems
necessary), roads, walkways, parking areas, and grounds that underpin
the laboratory and clinical facilities of the National Institutes of
Health. Such plan may make recommendations for the undertaking of new
projects that are consistent with the objectives of this section, such
as encircling the National Institutes of Health Federal enclave with an
adequate chilled water conduit.
SEC. 2003. CERTAIN AUTHORIZATION OF APPROPRIATIONS.
Section 399L(a) of the Public Health Service Act (42 U.S.C. 280e-
4(a)), as added by Public Law 102-515 (106 Stat. 3376), is amended--
(1) in the first sentence, by striking ``the Secretary'' and all
that follows and inserting the following: ``there are authorized to
be appropriated $30,000,000 for fiscal year 1994, and such sums as
may be necessary for each of the fiscal years 1995 through 1996.'';
and
(2) in the second sentence, by striking ``Out of any amounts
used'' and inserting ``Of the amounts appropriated under the
preceding sentence''.
SEC. 2004. BUY-AMERICAN PROVISIONS.
(a) Compliance With Buy American Act.--No funds appropriated
pursuant to this Act for any of the fiscal years 1994 through 1996 may
be expended by an entity unless the entity agrees that in expending the
assistance the entity will comply with sections 2 through 4 of the Act
of March 3, 1933 (41 U.S.C. 10a-10c, popularly known as the ``Buy
American Act'').
(b) Sense of Congress; Requirement Regarding Notice.--
(1) Purchase of american-made equipment and products.--In the
case of any equipment or product that may be authorized to be
purchased with financial assistance provided pursuant to this Act
for any of the fiscal years 1994 through 1996, it is the sense of
the Congress that entities receiving such assistance should, in
expending the assistance, purchase only American-made equipment and
products.
(2) Notice to recipients of assistance.--In providing financial
assistance pursuant to this Act, the Secretary of Health and Human
Services shall provide to each recipient of the assistance a notice
describing the statement made in paragraph (1) by the Congress.
SEC. 2005. PROHIBITION AGAINST FURTHER FUNDING FOR PROJECT ARIES.
For fiscal year 1994 and each subsequent fiscal year, the project
administered by the University of Washington at Seattle and known as
Project Aries may not receive any funding from any agency of the
National Institutes of Health (other than payments under awards made for
fiscal year 1993 or prior fiscal years) unless--
(1) the proposal for funding for the project has undergone
review in accordance with the applicable requirements of section 491
of the Public Health Service Act on restrictions regarding
institutional review boards and ethics guidance;
(2) the proposal for funding for the project has undergone
review in accordance with the applicable requirements of section 492
of such Act on restrictions regarding peer review;
(3) the Secretary of Health and Human Services, in accordance
with section 492A of such Act (as added by section 101 of this Act),
makes a determination that the project will assist--
(A) in reducing the incidence of infection with the human
immunodeficiency virus;
(B) in reducing the incidence of sexually transmitted
diseases; or
(C) in reducing the incidence of tuberculosis; and
(4) the data to be collected through the project cannot be
obtained in any other manner.
SEC. 2006. LOAN REPAYMENT PROGRAM.
Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
391 et seq.), as amended by Public Law 101-635, is amended--
(1) by redesignating the second section 903 as section 904; and
(2) by adding at the end the following section:
``SEC. 905. LOAN REPAYMENT PROGRAM.
``(a) In General.--
``(1) Authority for program.--Subject to paragraph (2), the
Secretary shall carry out a program of entering into contracts with
appropriately qualified health professionals under which such health
professionals agree to conduct research, as employees of the Food
and Drug Administration, in consideration of the Federal Government
agreeing to repay, for each year of such service, not more than
$20,000 of the principal and interest of the educational loans of
such health professionals.
``(2) Limitation.--The Secretary may not enter into an agreement
with a health professional pursuant to paragraph (1) unless such
professional--
``(A) has a substantial amount of educational loans relative
to income; and
``(B) agrees to serve as an employee of the Food and Drug
Administration for purposes of paragraph (1) for a period of not
less than 3 years.
``(b) Applicability of Certain Provisions.--With respect to the
National Health Service Corps Loan Repayment Program established in
subpart III of part D of title III of the Public Health Service Act, the
provisions of such subpart shall, except as inconsistent with subsection
(a) of this section, apply to the program established in such subsection
in the same manner and to the same extent as such provisions apply to
the National Health Service Corps Loan Repayment Program.
``(c) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated such sums as
may be necessary for each of the fiscal years 1994 through 1996.''.
SEC. 2007. EXCLUSION OF ALIENS INFECTED WITH THE AGENT FOR ACQUIRED
IMMUNE DEFICIENCY SYNDROME.
(a) Exclusion of Aliens on Health-Related Grounds.--Section
212(a)(1)(A)(i) of the Immigration and Nationality Act (8 U.S.C.
1182(a)(1)(A)(i)) is amended by adding at the end the following: ``which
shall include infection with the etiologic agent for acquired immune
deficiency syndrome,''.
(b) Effective Date.--The amendment made by subsection (a) shall take
effect 30 days after the date of the enactment of this Act.
SEC. 2008. TECHNICAL CORRECTIONS.
(a) Title III.--Section 316 of the Public Health Service Act (42
U.S.C. 247a(c)) is amended by striking subsection (c).
(b) Title IV.--Title IV of the Public Health Service Act (42 U.S.C.
281 et seq.) is amended--
(1) in section 406--
(A) in subsection (b)(2)(A), by striking ``Veterans'
Administration'' each place such term appears and inserting
``Department of Veterans Affairs''; and
(B) in subsection (h)(2)(A)(v), by striking ``Veterans'
Administration'' and inserting ``Department of Veterans
Affairs'';
(2) in section 408, in subsection (b) (as redesignated by
section 501(c)(1)(C) of this Act), by striking ``Veterans'
Administration'' and inserting ``Department of Veterans Affairs'';
(3) in section 421(b)(1), by inserting a comma after ``may'';
(4) in section 428(b), in the matter preceding paragraph (1), by
striking ``the the'' and inserting ``the'';
(5) in section 430(b)(2)(A)(i), by striking ``Veterans'
Administration'' and inserting ``Department of Veterans Affairs'';
(6) in section 439(b), by striking ``Veterans' Administration''
and inserting ``Department of Veterans Affairs'';
(7) in section 442(b)(2)(A), by striking ``Veterans'
Administration'' and inserting ``Department of Veterans Affairs'';
(8) in section 464D(b)(2)(A), by striking ``Veterans'
Administration'' and inserting ``Department of Veterans Affairs'';
(9) in section 464E--
(A) in subsection (d), in the first sentence, by inserting
``Coordinating'' before ``Committee''; and
(B) in subsection (e), by inserting ``Coordinating'' before
``Committee'' the first place such term appears;
(10) in section 464P(b)(6) (as added by section 123 of Public
Law 102-321 (106 Stat. 362)), by striking ``Administration'' and
inserting ``Institute'';
(11) in section 466(a)(1)(B), by striking ``Veterans'
Administration'' and inserting ``Department of Veterans Affairs'';
(12) in section 480(b)(2)(A), by striking ``Veterans'
Administration'' and inserting ``Department of Veterans Affairs'';
(13) in section 485(b)(2)(A), by striking ``Veterans'
Administration'' and inserting ``Department of Veterans Affairs'';
(14) in section 487(d)(3), by striking ``section 304(a)(3)'' and
inserting ``section 304(a)''; and
(15) in section 496(a), by striking ``Such appropriations,'' and
inserting the following: ``Appropriations to carry out the purposes
of this title,''.
(c) Title XV.--
(1) Limited authority regarding for-profit entities.--Section
1501(b) of the Public Health Service Act (42 U.S.C. 300k(b)) is
amended--
(A) by striking ``States.--A State'' and all that follows
through ``may expend'' and inserting the following: ``States.--
``(1) In general.--A State receiving a grant under subsection
(a) may, subject to paragraph (2), expend''; and
(B) by adding at the end the following paragraph:
``(2) Limited authority regarding other entities.--In addition
to the authority established in paragraph (1) for a State with
respect to grants and contracts, the State may provide for
screenings under subsection (a)(1) through entering into contracts
with private entities. The amount paid by a State to a private
entity under the preceding sentence for a screening procedure may
not exceed the amount that would be paid under part B of title XVIII
of the Social Security Act if payment were made under such part for
furnishing the procedure to a woman enrolled under such part.''.
(2) Conforming amendment.--Section 1505(3) of the Public Health
Service Act (42 U.S.C. 300n-1(3)) is amended by inserting before the
semicolon the following: ``(and additionally, in the case of
services and activities under section 1501(a)(1), with any similar
services or activities of private entities)''.
(d) Title XXIII.--Part A of title XXIII of the Public Health Service
Act (42 U.S.C. 300cc et seq.) is amended--
(1) in section 2304--
(A) in the heading for the section, by striking ``CLINICAL
RESEARCH REVIEW COMMITTEE'' and inserting ``RESEARCH ADVISORY
COMMITTEE''; and
(B) in subsection (a), by striking ``AIDS Clinical Research
Review Committee'' and inserting ``AIDS Research Advisory
Committee'';
(2) in section 2312(a)(2)(A), by striking ``AIDS Clinical
Research Review Committee'' and inserting ``AIDS Research Advisory
Committee'';
(3) in section 2314(a)(1), in the matter preceding subparagraph
(A), by striking ``Clinical Research Review Committee'' and
inserting ``AIDS Research Advisory Committee'';
(4) in section 2317(d)(1), by striking ``Clinical Research
Review Committee'' and inserting ``AIDS Research Advisory Committee
established under section 2304''; and
(5) in section 2318(b)(3), by striking ``Clinical Research
Review Committee'' and inserting ``AIDS Research Advisory
Committee''.
(e) Secretary.--Section 2(c) of the Public Health Service Act (42
U.S.C. 201(c)) is amended by striking ``Health, Education, and Welfare''
and inserting ``Health and Human Services''.
(f) Department.--Section 201 of the Public Health Service Act (42
U.S.C. 202) is amended--
(1) by striking ``Health, Education, and Welfare'' and inserting
``Health and Human Services''; and
(2) by striking ``Surgeon General'' and inserting ``Assistant
Secretary for Health''.
(g) Department.--Section 202 of the Public Health Service Act (42
U.S.C. 203) is amended--
(1) by striking ``Surgeon General'' the second and subsequent
times that such term appears and inserting ``Secretary''; and
(2) by inserting ``, and the Agency for Health Care Policy and
Research'' before the first period.
(h) Volunteer Services.--Section 223 of the Public Health Service
Act (42 U.S.C. 217b) is amended by striking ``Health, Education, and
Welfare'' and inserting ``Health and Human Services''.
(i) Miscellaneous.--
(1) Amendatory instructions.--
(A) Section 602(a) of Public Law 102-585 (106 Stat. 4967) is
amended by striking ``by adding the following subpart'' and
inserting ``by adding at the end the following subpart''.
(B) Public Law 102-531 is amended--
(i) in section 303(b) (106 Stat. 3488)--
(I) by striking ``Part A of title III'' and
inserting ``Part B of title III''; and
(II) by striking ``241 et seq.'' and inserting ``243
et seq.'';
(ii) in section 304 (106 Stat. 3490)--
(I) by striking ``Part A of title III'' and
inserting ``Part B of title III''; and
(II) by striking ``241 et seq.'' and inserting ``243
et seq.'';
(iii) in section 306 (106 Stat. 3494), by striking
``Part A of title III'' and inserting ``Part B of title
III''; and
(iv) in section 308 (106 Stat. 3495), by striking ``Part
A of title III'' and inserting ``Part B of title III'';
(2) Title III of public health service act.--Title III of the
Public Health Service Act (42 U.S.C. 241 et seq.), as amended by
Public Law 102-321, Public Law 102-515, Public Law 102-531, and
Public Law 102-585, by section 121(a) of this Act, and by paragraph
(1) of this subsection, is amended--
(A) in part D--
(i) by transferring subpart VIII from the current
placement of the subpart and inserting the subpart after
subpart VII; and
(ii) by redesignating section 340B of subpart VIII as
section 340C; and
(B)(i) by redesignating parts K and L as parts J and K,
respectively; and
(ii) by redesignating the part M added by Public Law 102-321
as part L.
(3) Title VII of public health service act.--Section 746(i)(1)
of the Public Health Service Act (42 U.S.C. 293j(i)(1)), as added by
section 102 of Public Law 102-408 (106 Stat. 1994) and amended by
section 313(a)(2)(B) of Public Law 102-531 (106 Stat. 3507), is
amended to read as if the amendment made by such section
313(a)(2)(B) had not been enacted.
SEC. 2009. BIENNIAL REPORT ON CARCINOGENS.
Section 301(b)(4) of the Public Health Service Act (42 U.S.C.
241(b)(4)) is amended by striking ``an annual'' and inserting ``a
biennial''.
SEC. 2010. TRANSFER OF PROVISIONS OF TITLE XXVII.
(a) In General.--The Public Health Service Act (42 U.S.C. 201 et
seq.), as amended by section 101 of Public Law 101-381 and section 304
of Public Law 101-509, is amended--
(1) by transferring sections 2701 through 2714 to title II;
(2) by redesignating such sections as sections 231 through 244,
respectively;
(3) by inserting such sections, in the appropriate sequence,
after section 228;
(4) by inserting before section 201 the following heading:
``Part A--Administration''; and
(5) by inserting before section 231 (as redesignated by
paragraph (2) of this subsection) the following heading:
``Part B--Miscellaneous Provisions''.
(b) Conforming Amendments.--The Public Health Service Act (42 U.S.C.
201 et seq.) is amended--
(1) in the heading for title II, by inserting ``AND
MISCELLANEOUS PROVISIONS'' after ``ADMINISTRATION'';
(2) in section 406(a)(2), by striking ``2701'' and inserting
``231'';
(3) in section 465(f), by striking ``2701'' and inserting
``231'';
(4) in section 480(a)(2), by striking ``2701'' and inserting
``231'';
(5) in section 485(a)(2), by striking ``2701'' and inserting
``231'';
(6) in section 497, by striking ``2701'' and inserting ``231'';
(7) in section 505(a)(2), by striking ``2701'' and inserting
``231'';
(8) in section 926(b), by striking ``2711'' each place such term
appears and inserting ``241''; and
(9) in title XXVII, by striking the heading for such title.
SEC. 2011. AUTHORIZATION OF APPROPRIATIONS.
Section 2602 of the Low-Income Home Energy Assistance Act of 1981
(42 U.S.C. 8621) is amended--
(1) in the first sentence of subsection (b), by striking ``1993
and 1994'' and inserting ``1993, 1994, and 1995''; and
(2) in subsection (d), by striking ``in each of the fiscal years
1993 and 1994'' and inserting ``for each of the fiscal years 1993,
1994, and 1995''.
SEC. 2012. VACCINE INJURY COMPENSATION PROGRAM.
Section 2111(a) of the Public Health Service Act (42 U.S.C. 300aa-
11(a)) is amended by adding at the end the following paragraph:
``(10) The Clerk of the United States Claims Court is authorized
to continue to receive, and forward, petitions for compensation for
a vaccine-related injury or death associated with the administration
of a vaccine on or after October 1, 1992.''.
SEC. 2013. TECHNICAL CORRECTIONS WITH RESPECT TO THE AGENCY FOR HEALTH
CARE POLICY AND RESEARCH.
Title IX of the Public Health Service Act is amended--
(1) in section 904(d) (42 U.S.C. 299a-2(d))--
(A) by striking ``In general'' in paragraph (1) and
inserting ``Additional assessments'';
(B) by redesignating paragraphs (1) and (2) as paragraphs
(3) and (4), respectively;
(C) by inserting after the subsection designation the
following paragraphs:
``(1) Recommendations with respect to health care technology.--
The Administrator shall make recommendations to the Secretary with
respect to whether specific health care technologies should be
reimbursable under federally financed health programs, including
recommendations with respect to any conditions and requirements
under which any such reimbursements should be made.
``(2) Considerations of certain factors.--In making
recommendations respecting health care technologies, the
Administrator shall consider the safety, efficacy, and
effectiveness, and, as appropriate, the appropriate uses of such
technologies. The Administrator shall also consider the cost
effectiveness of such technologies where cost information is
available and reliable.''; and
(D) by adding at the end the following paragraph:
``(5) Consultations.--In carrying out this subsection, the
Administrator shall cooperate and consult with the Director of the
National Institutes of Health, the Commissioner of Food and Drugs,
and the heads of any other interested Federal department or
agency.''; and
(2) in section 914(a)(2)(C), by striking ``904(c)(2)'' and
inserting ``904(d)(2)''.
SEC. 2014. TECHNICAL CORRECTIONS WITH RESPECT TO THE HEALTH PROFESSIONS
EDUCATION EXTENSION AMENDMENTS OF 1992.
(a) Insured Health Education Assistance Loans to Graduate
Students.--Subpart I of part A of title VII of the Public Health Service
Act (42 U.S.C. 292 et seq.), as added by section 102 of Public Law 102-
408 (106 Stat. 1994), is amended--
(1) in section 705(a)(2)--
(A) in subparagraph (G), by inserting ``and'' after the
semicolon at the end;
(B) by striking subparagraph (H); and
(C) by redesignating subparagraph (I) as subparagraph (H);
and
(2) in section 707--
(A) in subsection (g), by amending paragraph (1) to read as
follows:
``(1) after the expiration of the seven-year period beginning on
the first date when repayment of such loan is required, exclusive of
any period after such date in which the obligation to pay
installments on the loan is suspended;''; and
(B) by adding at the end the following subsection:
``(j) School Collection Assistance.--An institution or postgraduate
training program attended by a borrower may assist in the collection of
any loan of that borrower made under this subpart which becomes
delinquent, including providing information concerning the borrower to
the Secretary and to past and present lenders and holders of the
borrower's loans, contacting the borrower in order to encourage
repayment, and withholding services in accordance with regulations
issued by the Secretary under section 715(a)(7). The institution or
postgraduate training program shall not be subject to section 809 of the
Fair Debt Collection Practices Act for purposes of carrying out
activities authorized by this section.''.
(b) Loan Provisions.--Section 722 of the Public Health Service Act
(42 U.S.C. 292r), as added by section 102 of Public Law 102-408 (106
Stat. 1994), is amended--
(1) in subsection (a), by amending the subsection to read as
follows:
``(a) Amount of Loan.--
``(1) In general.--Loans from a student loan fund (established
under an agreement with a school under section 721) may not, subject
to paragraph (2), exceed for any student for a school year (or its
equivalent) the sum of--
``(A) the cost of tuition for such year at such school, and
``(B) $2,500.
``(2) Third and fourth years of medical school.--For purposes of
paragraph (1), the amount $2,500 may, in the case of the third or
fourth year of a student at school of medicine or osteopathic
medicine, be increased to the extent necessary (including such
$2,500) to pay the balances of loans that, from sources other than
the student loan fund under section 721, were made to the individual
for attendance at the school. The authority to make such an increase
is subject to the school and the student agreeing that such amount
(as increased) will be expended to pay such balances.''; and
(2) in subsection (b)--
(A) in paragraph (1), by adding ``and'' after the semicolon
at the end;
(B) by striking paragraph (2); and
(C) by redesignating paragraph (3) as paragraph (2).
(c) Medical Schools and Primary Health Care.--
(1) Requirements for students.--Section 723(a) of the Public
Health Service Act (42 U.S.C. 292s(a)), as added by section 102 of
Public Law 102-408 (106 Stat. 1994), is amended by adding at the end
the following paragraph:
``(4) Waivers.--
``(A) With respect to the obligation of an individual under
an agreement made under paragraph (1) as a student, the
Secretary shall provide for the partial or total waiver or
suspension of the obligation whenever compliance by the
individual is impossible, or would involve extreme hardship to
the individual, and if enforcement of the obligation with
respect to the individual would be unconscionable.
``(B) For purposes of subparagraph (A), the obligation of an
individual shall be waived if--
``(i) the status of the individual as a student of the
school involved is terminated before graduation from the
school, whether voluntarily or involuntarily; and
``(ii) the individual does not, after such termination,
resume attendance at the school or begin attendance at any
other school of medicine or osteopathic medicine.
``(C) If an individual resumes or begins attendance for
purposes of subparagraph (B), the obligation of the individual
under the agreement under paragraph (1) shall be considered to
have been suspended for the period in which the individual was
not in attendance.
``(D) This paragraph may not be construed as authorizing the
waiver or suspension of the obligation of a student to repay, in
accordance with section 722, loans from student loan funds under
section 721.''.
(2) Requirements for schools.--Section 723(b) of the Public
Health Service Act (42 U.S.C. 292s(b)), as added by section 102 of
Public Law 102-408 (106 Stat. 1994), is amended--
(A) in paragraph (1)--
(i) by striking ``1994,'' and inserting ``1997;''; and
(ii) by striking ``4 years before'' and inserting ``3
years before'';
(B) in paragraph (2)(B), by striking ``15 percent'' and
inserting ``25 percent''; and
(C) in paragraph (4)(B)--
(i) in clause (i), by striking ``1994,'' and inserting
``1997,''; and
(ii) in clause (ii), by striking ``1995,'' and inserting
``1998,''.
(d) Authorization of Appropriations Regarding Medical Schools.--
Section 735 of the Public Health Service Act (42 U.S.C. 292y), as added
by section 102 of Public Law 102-408 (106 Stat. 1994), is amended by
adding at the end the following subsection:
``(f) Funding for Certain Medical Schools.--
``(1) Authorization of appropriations.--For the purpose of
making Federal capital contributions to student loan funds
established under section 721 by schools of medicine or osteopathic
medicine, there is authorized to be appropriated $10,000,000 for
each of the fiscal years 1994 through 1996.
``(2) Minimum requirements.--
``(A) Subject to subparagraph (B), the Secretary may make a
Federal capital contribution pursuant to paragraph (1) only if
the school of medicine or osteopathic medicine involved meets
the conditions described in subparagraph (A) of section
723(b)(2) or the conditions described in subparagraph (C) of
such section.
``(B) For purposes of subparagraph (A), the conditions
referred to in such subparagraph shall be applied with respect
to graduates of the school involved whose date of graduation
occurred approximately 3 years before June 30 of the fiscal year
preceding the fiscal year for which the Federal capital
contribution involved is made.
(e) Public Health Traineeships.--Section 761(b)(3) of the Public
Health Service Act (42 U.S.C. 294(b)(3)), as added by section 102 of
Public Law 102-408 (106 Stat. 1994), is amended by striking ``and
nutrition'' and inserting ``nutrition, and maternal and child health''.
(f) Traineeships for Advanced Nurse Education.--Section 830(a) of
the Public Health Service Act, as added by section 206 of Public Law
102-408 (106 Stat. 2073), is amended--
(1) by striking ``meet the cost of traineeships for
individuals'' and inserting the following: ``meet the costs of--
``(1) traineeships for individuals'';
(2) by striking the period at the end and inserting ``; and'';
and
(3) by adding at the end the following paragraph:
``(2) traineeships for participation in certificate nurse
midwifery programs that conform to guidelines established by the
Secretary under section 822(b).''.
(g) Certain Generally Applicable Provisions.--Section 860(d) of the
Public Health Service Act (42 U.S.C. 298b-7(d)), as added by section 209
of Public Law 102-408 (106 Stat. 2075), is amended in the first sentence
by striking ``821, 822, 830, and 831'' and inserting ``821, 822, and
827''.
SEC. 2015. PROHIBITION AGAINST SHARP ADULT SEX SURVEY AND THE AMERICAN
TEENAGE SEX SURVEY.
The Secretary of Health and Human Services may not during fiscal
year 1993 or any subsequent fiscal year conduct or support the SHARP
survey of adult sexual behavior or the American Teenage Study of
adolescent sexual behavior. This section becomes effective on the date
of the enactment of this Act.
SEC. 2016. HEALTH SERVICES RESEARCH.
(a) Definition.--Section 409 of the Public Health Service Act (42
U.S.C. 284d), as added by section 121(b) of Public Law 102-321 (106
Stat. 358), is amended by adding at the end the following sentence:
``Such term does not include research on the efficacy of services to
prevent, diagnose, or treat medical conditions.''.
(b) Required Allocations.--
(1) In general.--With respect to the allocation for health
services research required in each of the provisions of law
specified in paragraph (2), the term ``15 percent'' appearing in
each of such provisions is, in the case of allocations for fiscal
year 1993, deemed to be 12 percent.
(2) Relevant provisions of law.--The provisions of law referred
to in paragraph (1) are--
(A) section 464H(d)(2) of the Public Health Service Act, as
added by section 122 of Public Law 102-321 (106 Stat. 358);
(B) section 464L(d)(2) of the Public Health Service Act, as
added by section 123 of Public Law 102-321 (106 Stat. 360); and
(C) section 464R(f)(2) of the Public Health Service Act, as
added by section 124 of Public Law 102-321 (106 Stat. 364).
(c) Report.--Section 494A(b) of the Public Health Service Act (42
U.S.C. 289c-1(b)), as added by section 125 of Public Law 102-321 (106
Stat. 366), is amended by striking ``May 3, 1993,'' and inserting
``September 30, 1993,''.
SEC. 2017. CHILDHOOD MENTAL HEALTH.
Part E of title V of the Public Health Service Act (42 U.S.C. 290ff
et seq.), as added by section 119 of Public Law 102-321 (106 Stat. 349),
is amended--
(1) in section 561--
(A) in subsection (a)(2), by striking ``this subpart'' and
inserting ``this part''; and
(B) in subsection (b)(1), by striking ``is receiving such
payments'' each place such term appears and inserting ``is such
a grantee''; and
(2) in section 565--
(A) in subsection (c)(1), by striking ``this subpart'' and
inserting ``this part'';
(B) in subsection (d), by striking ``this subpart'' and
inserting ``this part''; and
(C) in subsection (f)--
(i) in paragraph (1), by striking ``this subpart'' and
inserting ``this part''; and
(ii) by amending paragraph (2) to read as follows:
``(2) Limitation regarding technical assistance.--Not more than 10
percent of the amounts appropriated under paragraph (1) for a fiscal
year may be expended for carrying out subsection (b).''.
SEC. 2018. EXPENDITURES FROM CERTAIN ACCOUNT.
With respect to amounts appropriated in title II of Public Law 102-
394 for buildings and facilities of the National Institutes of Health,
the purposes for which such amounts may be expended include repairing,
improving, or constructing (or any combination thereof) roads on non-
Federal property in close proximity to the main campus of the National
Institutes of Health in Bethesda, Maryland, subject to the agreement of
the appropriate officials of Montgomery County, Maryland, or the
appropriate officials of the State of Maryland, or both, as the case may
be. None of such amounts may be used for the non-Federal share of the
cost of any project or activity under title 23, United States Code, the
Intermodal Surface Transportation Efficiency Act of 1991, or any law
amended by such Act.
TITLE XXI--EFFECTIVE DATES
SEC. 2101. EFFECTIVE DATES.
Subject to section 203(c), this Act and the amendments made by this
Act take effect upon the date of the enactment of this Act.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.