[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 1 Introduced in Senate (IS)]
103d CONGRESS
1st Session
S. 1
To amend the Public Health Service Act to revise and extend the
programs of the National Institutes of Health, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
January 21 (legislative day, January 5), 1993
Mr. Kennedy (for himself, Mrs. Boxer, Mr. Wellstone, Mr. Dodd, Mr.
Lautenberg, Ms. Mikulski, Mr. Pell, Mr. Simon, Mr. Wofford, Mr. Inouye,
Mr. Sarbanes, Ms. Moseley-Braun, Mr. Leahy, Mr. Riegle, Mr.
Durenberger, and Mr. Metzenbaum) introduced the following bill; which
was read twice and referred to the Committee on Labor and Human
Resources
_______________________________________________________________________
A BILL
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. Applicability 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--Scientific Integrity
Sec. 161. Establishment of Office of Scientific Integrity.
Sec. 162. Commission on Scientific 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. Effective dates.
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. Children's vaccine initiative.
Sec. 204. Plan for use of animals in research.
Sec. 205. Increased participation of women and members of
underrepresented minorities in fields of
biomedical and behavioral research.
Sec. 206. Requirements regarding surveys of sexual behavior.
Sec. 207. Discretionary fund of Director of National Institutes of
Health.
Sec. 208. 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 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.
Sec. 504. Authorization of appropriations.
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 research on diabetes eye care.
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 National Institutes of Health
Sec. 1631. Establishment of programs.
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. Establishment of Foundation.
TITLE XVIII--RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY
SYNDROME
Sec. 1801. Revision and extension of various programs.
TITLE XIX--STUDIES
Sec. 1901. Acquired immune deficiency syndrome.
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. Report concerning leading causes of death.
Sec. 1908. Relationship between the consumption of legal and illegal
drugs.
TITLE XX--MISCELLANEOUS PROVISIONS
Sec. 2001. Designation of Senior Biomedical Research Service in honor
of Silvio Conte, and limitation on number
of members.
Sec. 2002. Technical corrections.
Sec. 2003. Biennial report on carcinogens.
Sec. 2004. Master plan for physical infrastructure for research.
Sec. 2005. Transfer of provisions of title xxvii.
Sec. 2006. Certain authorization of appropriations.
Sec. 2007. Prohibition against SHARP adult sex survey and the American
teenage sex survey.
Sec. 2008. Support for bioengineering research.
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 new
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 application
submitted to the Secretary for financial assistance to conduct
research, the Secretary may not approve or fund any application
that is subject to technical and scientific peer review under
section 492(a) unless the application has undergone peer 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 funding for the
research on ethical grounds unless--
``(A) the Secretary convenes an advisory board in
accordance with paragraph (4) to study the ethical
implications of the research; and
``(B) the majority of the advisory board recommends
that, on ethical grounds, the Secretary withhold funds
for the research.
``(2) Applicability.--The limitation established in
paragraph (1) regarding the authority to withhold funds on
ethical grounds shall apply without regard to whether the
withholding of funds is characterized as a disapproval, a
moratorium, a prohibition, or other description.
``(3) 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.
``(4) Ethics advisory boards.--
``(A) Any advisory board convened for purposes of
paragraph (1) shall be known as an ethics advisory
board (hereafter 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 (3)(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) With respect to information relevant to the
duties described in subparagraph (B)(i), an ethics
board shall have access to all such 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 such staff and other assistance as
may be necessary 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.''.
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 new
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 the tissue to be used in
such research; and
``(ii) no alteration of the timing, method,
or procedures used to terminate the pregnancy
was made solely for the purposes of obtaining
the tissue;
``(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 subsequent 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 (a)(3), (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) conduct the research in accordance with applicable State
and local law.
``(2) Research conducted by secretary.--The Secretary may
conduct research under subsection (a) only in accordance with
applicable State and local law.
``(f) 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 new 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.--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
section 492A(a) of the Public Health Service Act (as
added by section 101 of this Act);
(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)(4)(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 there are no ethical grounds for
withholding funds for 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 Regulation.--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 new section:
``inclusion of women and minorities in clinical research
``Sec. 492B. (a) In conducting or supporting clinical research for
purposes of this title, the Director of NIH shall, subject to
subsection (b), ensure that--
``(1) women are included as subjects in each project of
such research; and
``(2) members of minority groups are included as subjects
in such research.
``(b) 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) In the case of any project of clinical research in which
women or members of minority groups will under subsection (a) be
included as subjects in the research, the Director of NIH shall ensure
that the project is designed and carried out in a manner sufficient to
provide for a valid analysis of whether the variables being tested in
the research affect women or members of minority groups, as the case
may be, differently than other subjects in the research.
``(d)(1) The Director of NIH, in consultation with the Director of
the Office of Research on Women's Health, shall establish guidelines
regarding--
``(A) the circumstances under which the inclusion of women
and minorities in projects of clinical research is
inappropriate for purposes of subsection (b);
``(B) the manner in which such projects are required to be
designed and carried out for purposes of subsection (c),
including a specification of the circumstances in which the
requirement of such subsection does not apply on the basis of
impracticability; and
``(C) the conduct of outreach programs for the recruitment
of women and members of minority groups as subjects in such
research.
``(2) With respect to the circumstances under which the inclusion
of women or members of minority groups (as the case may be) as subjects
in clinical research is inappropriate for purposes of subsection (b),
the guidelines established under paragraph (1)(A)--
``(A) shall provide that the costs of such inclusion in a
project of clinical research is not a permissible consideration
in determining whether such inclusion is inappropriate unless
the data of comparable quality regarding women or members of
minority groups, respectively, that would be obtained in such
project in the event that such inclusion were required will be
obtained through other means; and
``(B) may provide that such inclusion in a project of
clinical research 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 project 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 project
in the event that such inclusion were not required.
``(3) The guidelines required in paragraph (1) shall be established
and published in the Federal Register not later than 120 days after the
date of the enactment of the National Institutes of Health
Revitalization Act of 1993.
``(4) For fiscal year 1994 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 subsection (a).
``(e) The advisory council of each national research institute
shall annually submit to the Director of NIH and the Director of the
institute involved a report describing the manner in which the agency
has complied with subsection (a).''.
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 new 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(a).
``(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. APPLICABILITY 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 section 2 of Public Law 101-613, 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 new 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 (hereafter
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 (hereafter in
this subsection referred to as the `Advisory Committee').
``(2)(A) 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.
``(B) Members of the Advisory Committee shall receive
compensation for each day engaged in carrying out the duties of
the Committee, 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.
``(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, 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 new
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 new section:
``office of research on minority health
``Sec. 403A. (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--Scientific Integrity
SEC. 161. ESTABLISHMENT OF OFFICE OF SCIENTIFIC INTEGRITY.
(a) In General.--Section 493 of the Public Health Service Act (42
U.S.C. 289b) is amended to read as follows:
``office of scientific integrity
``Sec. 493. (a) Establishment.--
``(1) In general.--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 Scientific Integrity
(hereafter 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) 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 scientific
misconduct. The Secretary shall carry out this section acting
through the Director of the Office. The Director shall report
to the Secretary.
``(b) Existence of Administrative Processes as Condition of Funding
for Research.--The Secretary shall by regulation require that each
entity that applies for a grant, contract, or cooperative agreement
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 grant, contract, or cooperative agreement assurances satisfactory
to the Secretary that such entity--
``(1) has established (in accordance with regulations which
the Secretary shall prescribe) an administrative process to
review reports of scientific misconduct in connection with
biomedical and behavioral research conducted at or sponsored by
such entity; and
``(2) will report to the Director any investigation of
alleged scientific misconduct in connection with projects for
which funds have been made available under this Act that
appears substantial.
``(c) Process for Response of Director.--The Secretary shall
establish by regulation a process to be followed by the Director for
the prompt and appropriate--
``(1) response to information provided to the Director
respecting scientific misconduct in connection with projects
for which funds have been made available under this Act;
``(2) receipt of reports by the Director of such
information from recipients of funds under this Act;
``(3) conduct of investigations, when appropriate; and
``(4) taking of other actions, including appropriate
remedies, with respect to such misconduct.
``(d) Monitoring by Director.--The Secretary shall by regulation
establish procedures for the Director to monitor administrative
processes and investigations that have been established or carried out
under this section.
``(e) Effect on Present Investigations.--Nothing in this section
shall affect investigations which have been or will be commenced prior
to the promulgation of final regulations under this section.''.
(b) Establishment of Definition of Scientific Misconduct.--Not
later than 90 days after the date on which the report required under
section 152(d) is submitted to the Secretary of Health and Human
Services, such Secretary shall by regulation establish a definition for
the term ``scientific misconduct'' for purposes of section 493 of the
Public Health Service Act, as amended by subsection (a) of this
section.
SEC. 162. COMMISSION ON SCIENTIFIC INTEGRITY.
(a) In General.--The Secretary of Health and Human Services shall
establish a commission to be known as the Commission on Scientific
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 from among
individuals who are not officers or employees of the United States. Of
the members appointed to 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
scientific 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
paragraphs (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 shall receive
compensation for each day engaged in carrying out the duties of the
Commission, 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.
(e) Report.--Not later than 120 days after the date of enactment of
this section, 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 new
subsection:
``(f) 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 scientific
misconduct; or
``(B) cooperated with an investigation of such an
allegation.
``(2) Monitoring by secretary.--The Secretary shall
establish by regulation 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.
``(4) Final rule for regulations.--The Secretary shall
issue a final rule for the regulations required in paragraph
(1) not later than 180 days after the date of the enactment of
the National Institutes of Health Revitalization Act of 1993.
``(5) Required agreements.--For any fiscal year beginning
after the date on which the regulations required in paragraph
(1) are issued, the Secretary may not provide a grant,
cooperative agreement, or contract under this Act for
biomedical or behavioral research unless the entity seeking
such financial assistance agrees that the entity--
``(A) will maintain the procedures described in the
regulations; and
``(B) will otherwise be subject to the
regulations.''.
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.--
``(1) In general.--The Secretary shall define by
regulation, 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 paragraph (2),
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.
``(2) Relevant projects.--A project of research referred to
in paragraph (1) 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.
``(3) Identifying and reporting to the director.--The
Secretary shall ensure that the standards established under
paragraph (1) specify that as a condition of receiving
assistance from the Secretary for the project involved, an
entity described in such subsection is required--
``(A) to have in effect at the time the entity
applies for the assistance and throughout the period
during which the assistance is received, a process for
identifying such financial interests as defined in
paragraph (1) that exist regarding the project; and
``(B) to report to the Director such financial
interest as defined in paragraph (1) identified by the
entity and how any such financial interest identified
by the entity will be managed or eliminated such that
the project in question will be protected from bias
that may stem from such financial interest.
``(4) Monitoring of process.--The Secretary shall monitor
the establishment and conduct of the process established by an
entity pursuant to paragraph (1).
``(5) Response.--In any case in which the Secretary
determines that an entity has failed to comply with paragraph
(3) regarding a project of research described in paragraph (1),
the Secretary--
``(A) shall require that, as a condition of
receiving assistance, the entity disclose the existence
of a financial interest as defined in paragraph (1) in
each public presentation of the results of such
project; and
``(B) may take such other actions as the Secretary
determines to be appropriate.
``(6) Definition.--As used in this section:
``(A) The term `financial interest' includes the
receipt of consulting fees or honoraria and the
ownership of stock or equity.
``(B) The term `assistance', with respect to
conducting a project of research, means a grant,
contract, or cooperative agreement.
``(b) Final Rule for Regulations.--The Secretary shall issue a
final rule for the regulations required in subsection (a) not later
than 180 days after the date of the enactment of the National
Institutes of Health Revitalization Act of 1993.''.
SEC. 165. EFFECTIVE DATES.
(a) In General.--The amendments made by this subtitle shall become
effective on the date that occurs 180 days after the date on which the
final rule required under section 493(f)(4) of the Public Health
Service Act, as amended by sections 161 and 163, is published in the
Federal Register.
(b) Agreements as a Condition of Funding.--The requirements of
subsection (f)(5) of section 493 of the Public Health Service Act, as
amended by sections 161 and 163, with respect to agreements as a
condition of funding shall not be effective in the case of projects of
research for which initial funding under the Public Health Service Act
was provided prior to the effective date described in subsection (a).
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 new 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. CHILDREN'S VACCINE INITIATIVE.
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 new section:
``children's vaccine initiative
``Sec. 404. (a) Development of New Vaccines.--The Secretary, in
consulation 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. 204. 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 203 of this Act, is amended by adding at the
end the following new section:
``plan for use of animals in research
``Sec. 404A. (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; and
``(C) methods of such research and experimentation
that produce less pain and distress in such animals;
``(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 (hereafter 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.''.
(b) Conforming Amendment.--Section 4 of the Health Research
Extension Act of 1985 (Public Law 99-158; 99 Stat. 880) is repealed.
SEC. 205. INCREASED PARTICIPATION OF WOMEN AND MEMBERS OF
UNDERREPRESENTED MINORITIES 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 new
subsection:
``(h) The Secretary, acting through the Director of NIH and the
Directors of the agencies of the National Institutes of Health, may
conduct and support programs for research, research training,
recruitment, and other activities to provide for an increase in the
number of women and members of underrepresented minority groups in the
fields of biomedical and behavioral research.''.
SEC. 206. REQUIREMENTS REGARDING SURVEYS OF SEXUAL BEHAVIOR.
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
new section:
``requirements regarding surveys of sexual behavior
``Sec. 404B. 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. 207. DISCRETIONARY FUND OF DIRECTOR OF NATIONAL INSTITUTES OF
HEALTH.
Section 402 of the Public Health Service Act, as amended by section
205 of this Act, is amended by adding at the end the following new
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. 208. 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 been
appointed'' 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 thereof the following new
paragraph:
``(5) ensure that, after January 1, 1994, at least one-half
of all new or revised health education and promotion materials
developed or funded by the National Institutes of Health is 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 207 of this Act, is
amended by adding at the end the following new subsection:
``(i)(1) The Director of NIH may establish a program to provide day
care service 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 service, 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 new
subparagraph:
``(C) shall 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 new section:
``research on osteoporosis, paget's disease, and related bone disorders
``Sec. 410. (a) Establishment.--The Directors of the National
Institute of Arthritis and Musculoskeletal and Skin Diseases, the
National Institute on Aging, and the National Institute of Diabetes,
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.) is amended by adding at the end the following
part:
``Part E--Interagency Program for Trauma Research
``SEC. 1251. ESTABLISHMENT OF PROGRAM.
``(a) In General.--The Secretary, acting through the Director of
the National Institutes of Health (hereafter in this section referred
to as the `Director'), shall establish a comprehensive program of
conducting basic and clinical research on trauma (hereafter 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 June 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 (hereafter 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 208(c) of this Act, is amended by adding at
the end the following new subsection:
``(k) The Director of NIH shall carry out the program established
in part E 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
new 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;
``(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 May 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 new 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 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 May 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 new section:
``authorization of appropriations
``Sec. 417B. (a) Activities Generally.--For the purpose of carrying
out this subpart, there are authorized to be appropriated
$2,200,000,000 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.--Of the amounts
appropriated for the National Cancer Institute for a fiscal year, the
Director of the Institute shall make available not less than 10 percent
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.''.
(b) Special Rule Regarding Funds for Section 412 for Fiscal Year
1994.--Notwithstanding section 417B(d) of the Public Health Service
Act, as added by subsection (a) of this section, the amount made
available under such section for fiscal year 1994 for carrying out
section 412 of such Act shall be an amount not less than an amount
equal to 75 percent of the amount specified for activities under such
section 412 in the budget estimate made under section 413(b)(9) of such
Act for such fiscal year.
(c) 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 new
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 thereof the following new
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.
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
new section:
``national center on sleep disorders
``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 (in this section referred to as the `Center'). The
Center shall headed by a director, who shall be appointed by the
Director of the Institute.
``(b) The general purpose of the Center is the conduct and support
of research, training, health information dissemination, and other
activities with respect to sleep disorders.''.
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. (a) 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.
``(b) Of the amounts appropriated under paragraph (1) for a fiscal
year, the Director of the Institute shall make available not less than
10 percent for carrying out community-based prevention and control
activities that include clinical investigations, clinical trials,
epidemiologic studies, and prevention demonstration and education
projects.''.
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
new section:
``nutritional disorders program
``Sec. 434. (a) The Director of the Institute 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. The Director of NIH shall
ensure that, as appropriate, the other national research institutes and
agencies of the National Institutes of Health have responsibilities
regarding such activities.
``(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 new
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 thereof the following new
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 thereof the following
new subsection:
``(f) Not later than October 1, 1994, 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 first place such term appears 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--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 new 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 new 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(b))
is amended--
(1) in subsection (b)(1), in the first sentence, by
inserting after ``Council'' the following: ``on Alzheimer's
Disease (hereafter in this section referred to as the
`Council')''; and
(2) by adding at the end the following new subsection:
``(d) 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 new 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 new 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 agreements 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 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 appropriated 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
appropriated.''.
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 new 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 new 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 new section:
``prospective longitudinal study on adolescent health
``Sec. 452D. (a) In General.--The Director of the Institute shall
conduct 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.
``(d) Allocation of Funds for Study.--Of the amounts appropriated
for each of the fiscal years 1994 through 1996 for the National
Institute of Child Health and Human Development, the Secretary of
Health and Human Services, acting through the Director of such
Institute, shall reserve $3,000,000 to conduct the study required in
subsection (a). The amounts so reserved shall remain available until
expended.''.
TITLE XI--NATIONAL EYE INSTITUTE
SEC. 1101. CLINICAL RESEARCH ON DIABETES EYE CARE.
(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 new 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
not more than three grants for the establishment and support of centers
for clinical research on eye care for individuals with diabetes.
``(b) Authorized Expenditures.--The purposes for which a grant
under subsection (a) may be expended include equipment for the research
described in such subsection and the construction and modernization of
facilities for such research.''.
(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
new 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 new 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: ``(hereafter 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 new
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-S(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 new 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 new 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
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 (hereafter 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
new 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 (hereafter 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 (hereafter 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 such appointed and ex officio members as
the Director of the Center may determine.
``(B) Not more than 3 individuals who are officers
or employees of the Federal Government may serve as
members of the Board.
``(C) Of the members of the Board--
``(i) 12 shall be appointed by the Director
of the Center (without regard to the civil
service laws); and
``(ii) 1 shall be an official of the
National Science Foundation designated by the
National Science 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 the 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
establish subcommittees, 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 board who are not officers
or employees of the United States 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.
``(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 (i) 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 a
significant percentage of whose population has
a health-status deficit, and the applicant
provides health services to such population; 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) Noninterference With Administration of Entities.--Except as
otherwise specifically provided in this section, nothing contained in
this part shall be construed as authorizing any department, agency,
officer, or employee of the United States to exercise any direction,
supervision, or control over, or impose any requirement or condition
with respect to the administration of any entity funded under this
part.
``(h) 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).
``(i) 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 new 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(i) $7,000,000 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 (hereafter 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 institute 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 new subparagraph:
``(Q) The National Institute of Nursing
Research.''; and
(B) in paragraph (2), by striking subparagraph (D).
(2) Transfer of statutory provisions.--Sections 483 through
485A of the Public Health Service Act, as amended by subsection
(a) of this section--
(A) are transferred to part C of title IV of such
Act;
(B) are redesignated as sections 464V through 464Y
of such part; and
(C) are inserted, 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 new heading:
``Subpart 17--National Institute of Nursing Research'';
and
(B) by striking the 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
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
October 1, 1994, 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 sections
141(a)(1) and 1611(b)(1)(B) of this Act, is amended--
(1) in section 401(b)(2), by adding at the end the
following new subparagraph:
``(D) The National Center for Human Genome Research.''; and
(2) in part E, by adding at the end the following new
subpart:
``Subpart 4--National Center for Human Genome Research
``purpose of the center
``Sec. 485B. (a) The general purpose of the National Center for
Human Genome Research (hereafter 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 issues associated with the genome project.
``(b)(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 members from
underrepresented minority groups, into fields of biomedical or
behavioral research and in the provision of research training to women
and such individuals.''.
SEC. 1602. SERVICE PAYBACK REQUIREMENTS.
Paragraph (2) of section 487(c) of the Public Health Service Act
(42 U.S.C. 288(c)(2)) is amended to read as follows:
``(2)(A) For the initial year for which an individual receives a
National Research Service Award for the conduct of postdoctoral
training or research, such individual shall engage in one year of
health research or teaching or any combination thereof which is in
accordance with the usual patterns of academic employment, or complete
a second year of training or research under such Award.
``(B) Service obligations for National Research Service Awards that
are less than 12 months may be satisfied--
``(i) by the conduct of health research or teaching or any
combination thereof which is in accordance with the usual
patterns of academic employment for a period of time equal to
the amount of time under the Award; or
``(ii) by reimbursing the Federal Government for the
amounts provided to such individual under the Award.
Subtitle B--Acquired Immune Deficiency Syndrome
SEC. 1611. LOAN REPAYMENT PROGRAM.
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.--
``(1) Authority for program.--Subject to paragraph (2), 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.
``(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)(i) was not employed at the National
Institutes of Health during the 1-year period preceding
the date of the enactment of the Health Professions
Reauthorization Act of 1988; or
``(ii) agrees to serve as an employee of such
Institutes 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.
``(c) Funding; Reimbursable Transfers.--
``(1) 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.
``(2) Transfers for related program.--The Commissioner of
Food and Drugs may carry out for the Food and Drug
Administration a program similar to the program established in
subsection (a), which program shall be carried out with respect
to the review of applications concerning acquired immune
deficiency syndrome that are submitted to such Commissioner.
From the amounts appropriated under paragraph (1) for a fiscal
year, the Secretary may transfer amounts to the Commissioner
for the purpose of carrying out such program. The Commissioner
shall provide a reimbursement to the Secretary for the amount
so transferred, and the reimbursement shall be available only
for the program established in subsection (a). Any transfer and
reimbursement made for purposes of this paragraph for a fiscal
year shall be completed by April 1 of such year.''.
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 new 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 agreements
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)(i) was not employed at the National
Institutes of Health during the 1-year period preceding
the date of the enactment of the Health Professions
Reauthorization Act of 1988; or
``(ii) agrees to serve as an employee of such
Institutes 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.
``(c) Authorization of Appropriations.--For the purpose of carrying
out this section other than with respect to acquired immune deficiency
syndrome, there are authorized to be appropriated such sums as may be
necessary for each of the fiscal years 1994 through 1996.''.
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 new 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 minority groups that are
underrepresented in the fields of biomedical or
behavioral research.
``(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 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. Payments to the institution under the contract may
be made without regard to section 3324 of title 31, United
States Code.
``(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 adding at the end the following new 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 D--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. ESTABLISHMENT OF FOUNDATION.
Section 499 of the Public Health Service Act, as redesignated by
section 121(b), is amended to read as follows:
``SEC. 499A. ESTABLISHMENT AND DUTIES OF FOUNDATION.
``(a) In General.--The Secretary shall establish a nonprofit
corporation to be known as the National Foundation for Biomedical
Research (hereafter in this section referred to as the `Foundation').
The Foundation shall not, except for the purposes of the Ethics in
Government Act and the Technology Transfer Act, be an agency or
instrumentality of the United States Government.
``(b) Purpose of Foundation.--The purpose of the Foundation shall
be to conduct and support research with respect to any particular
disease or groups of diseases or any other aspect of human health.
``(c) Endowment Fund.--
``(1) In general.--In carrying out subsection (b), the
Foundation shall establish a fund whose primary purpose shall
be to provide endowments for positions at the National
Institutes of Health to conduct biomedical research, and
dedicated to the purpose described in such subsection. Such
positions may be held by scientists without regard to whether
the scientists are employees of the Federal Government. Subject
to subsection (g)(1)(B), the fund shall consist of such
donations as may be provided by non-Federal entities and such
non-Federal assets of the Foundation (including earnings of the
Foundation and the fund) as the Foundation may elect to
transfer to the fund.
``(2) Authorized expenditures of fund.--The provision of
endowments under paragraph (1) shall be the primary function of
the fund established under such paragraph. Such endowments may
be expended only for the compensation of individuals holding
the positions, for staff, equipment, quarters, travel, and
other expenditures that are appropriate in supporting the
positions, and for recruiting individuals to hold the positions
endowed by the fund.
``(d) Certain Activities of Foundation.--In carrying out subsection
(b), and subject to subsection (c), the Foundation may provide for the
following with respect to the purpose described in such subsection:
``(1) Endowed chairs for distinguished senior
investigators.
``(2) Positions for support of visiting scientists in mid-
career who participate in the National Institutes of Health
Scholars program.
``(3) Studies, projects, and research conducted by
scientists under paragraphs (1) and (2).
``(4) Forums for the exchange of information between
scientists. Participants in such forums may include
institutions of higher education and appropriate private and
public organizations.
``(5) Meetings, conferences, courses, and training
workshops.
``(6) Programs to improve the collection and analysis of
data.
``(7) Programs for writing, editing, printing, and
publishing of books and other materials.
``(8) Other activities to carry out the purpose described
in subsection (b).
``(e) Powers.--In carrying out subsection (b), the Foundation
shall--
``(1) operate under the direction of its Board;
``(2) adopt, alter, and use a corporate seal, which shall
be judicially noticed;
``(3) provide for 1 or more officers, employees, and
agents, as may be necessary, define their duties, and require
surety bonds or make other provisions against losses occasioned
by acts of such persons;
``(4) hire, promote, compensate, and discharge officers and
employees of the Foundation;
``(5) prescribe by its Board its bylaws, as described in
subsection (g)(1)(A);
``(6) with the consent of any executive department or
independent agency, use the information, services, staff, and
facilities of such in carrying out this section;
``(7) sue and be sued in its corporate name, and complain
and defend in courts of competent jurisdiction;
``(8) modify or consent to the modification of any contract
or agreement to which it is a party or in which it has an
interest under this subtitle;
``(9) establish a mechanism for the selection of
candidates, subject to the approval of the Director of the
National Institutes of Health for the endowed scientific
positions within the organizational structure of the intramural
research programs of the National Institutes of Health and
candidates for participation in the National Institutes of
Health Scholars program;
``(10) enter into contracts with public and private
organizations for the writing, editing, printing, and
publishing of books and other material;
``(11) take such action as may be necessary to obtain
patents and licenses for devices and procedures developed by
the Foundation and its employees;
``(12) accept, hold, administer, invest, and spend any
gift, devise, or bequest of real or personal property made to
the Foundation;
``(13) enter into such other contracts, leases, cooperative
agreements, and other transactions as the Executive Director
considers appropriate to conduct the activities of the
Foundation;
``(14) appoint other groups of advisors as may be
determined necessary from time to time to carry out the
functions of the Foundation; and
``(15) exercise other powers as set forth in this section,
and such other incidental powers as are necessary to carry out
its powers, duties, and functions in accordance with this
subtitle.
``(f) General Structure of Foundation; Nonprofit Status.--
``(1) Board of directors.--The Foundation shall have a
board of directors (in this part referred to as the `Board'),
which shall be established and conducted in accordance with
subsection (g). The Board shall establish the general policies
of the Foundation for carrying out subsection (b), including
the establishment of the bylaws of the Foundation.
``(2) Executive director.--The Foundation shall have an
executive director (in this part referred to as the
`Director'), who shall be appointed by the Board, who shall
serve at the pleasure of the Board, and for whom the Board
shall establish the rate of compensation. Subject to compliance
with the policies and bylaws established by the Board pursuant
to paragraph (1), the Director shall be responsible for the
daily operations of the Foundation in carrying out subsection
(b).
``(3) Nonprofit status.--In carrying out subsection (b),
the Board shall establish such policies and bylaws under
paragraph (1), and the Director shall carry out such activities
under paragraph (2), as may be necessary to ensure that the
Foundation maintains status as an organization that--
``(A) is described in subsection (c)(3) of section
501 of the Internal Revenue Code of 1986; and
``(B) is, under subsection (a) of such section,
exempt from taxation.
``(4) Liaison.--The Director of the National Institutes of
Health shall serve as the liaison representative of the
National Institutes of Health to the Board and the Foundation.
``(g) Board of Directors.--
``(1) Certain bylaws.--
``(A) In establishing bylaws under subsection
(f)(1), the Board shall ensure that the bylaws of the
Foundation include bylaws for the following:
``(i) Policies for the selection of the
officers, employees, agents, and contractors of
the Foundation.
``(ii) Policies for the acquisition,
holding, and transfer of property.
``(iii) Policies, including ethical
standards, for the acceptance and disposition
of donations to the Foundation and for the
disposition of the assets of the Foundation.
``(iv) Policies for the conduct of the
general operations of the Foundation.
``(v) Policies for writing, editing,
printing, and publishing of books and other
materials, and the acquisition of patents and
licenses for devices and procedures developed
by the Foundation.
``(B) In establishing bylaws under subsection
(f)(1), the Board shall ensure that the bylaws of the
Foundation (and activities carried out under the
bylaws) do not--
``(i) reflect unfavorably upon the ability
of the Foundation, or the 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 program or
any officer or employee involved in such
program.
``(2) Composition.--
``(A) The Foundation shall have a Board of
Directors (hereafter referred to in this section as the
`Board'), which shall initially be composed of ex
officio and appointed members in accordance with this
subsection until such time as all the appointed
members, including the Chairperson, are fully appointed
by the Board under paragraph (4).
``(B) The ex officio members of the Council shall
be--
``(i) the Chairperson and ranking minority
member of the Subcommittee on Health and the
Environment (Committee on Energy and Commerce)
or their designees, in the case of the House of
Representatives;
``(ii) the Chairperson and ranking minority
member of the Committee on Labor and Human
Resources or their designees, in the case of
the Senate; and
``(iii) the Director of the National
Institutes of Health.
``(C) The ex officio members of the Board under
subparagraph (B) shall appoint to the Council 9
individuals. Of such appointed members--
``(i) 2 shall be representatives of the
general biomedical field;
``(ii) 2 shall be representatives of the
general biobehavorial field; and
``(iii) 3 shall be representatives of the
general public.
``(3) Chairperson.--The ex officio members of the Board
under paragraph (2)(B) shall designate an appointed member of
the Board to serve as the first Chairperson of the Board.
Subsequently, the Chairperson of the Board shall be chosen by
the Board according to its bylaws.
``(4) Appointments, vacancies, and terms.--The following
shall apply to the Board:
``(A) Any vacancy in the membership of the Board
shall be filled by appointment by the Board, after
consideration of suggestions made by the Chairperson
and the Director regarding the appointments. Any such
vacancy shall be filled not later than the expiration
of the 180-day period beginning on the date on which
the vacancy occurs.
``(B) The term of office of each member of the
Board appointed under subparagraph (A) shall be 5
years, except that the terms of office for the initial
appointed members of the Board shall expire as
determined by the Chairperson of the Board, in
consultation with the Director of the National
Institutes of Health.
``(C) A vacancy in the membership of the Board
shall not affect the power of the Board to carry out
the duties of the Board. If a member of the Board does
not serve the full term applicable under subparagraph
(B), the individual appointed to fill the resulting
vacancy shall be appointed for the remainder of the
term of the predecessor of the individual.
``(5) Compensation.--Members of the Board may not receive
compensation for service on the Board. Such members may be
reimbursed for travel, subsistence, and other necessary
expenses incurred in carrying out the duties of the Board, as
set forth in the bylaws issued by the Board.
``(h) Incorporation.--The initial members of the Board shall serve
as incorporators and shall take whatever actions necessary to
incorporate the Foundation.
``(i) General Provisions.--
``(1) Administrative control.--No officer, employee, or
member of the Board of the Foundation may exercise any
administrative or managerial control over any Federal employee.
``(2) 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 with
financial support from the Foundation, the Foundation shall
negotiate a memorandum of understanding with the individual and
the Director of the National Institutes of Health specifying
that the individual--
``(A) shall be subject to the ethical and
procedural standards regulating Federal employment,
scientific investigation, and research findings
(including publications and patents) that are required
of individuals employed by the National Institutes of
Health, including standards under this Act, the Ethics
in Government Act, and the Technology Transfer Act; and
``(B) shall be subject to such ethical and
procedural standards under chapter 11 of title 18,
United States Code (relating to conflicts of interest),
as the Director of the National Institutes of Health
determines is appropriate, except such memorandum may
not provide that the individual shall be subject to the
standards of section 209 of such chapter.
``(3) Financial conflicts of interest.--Any individual who
is an officer, employee, or member of the Board of the
Foundation may not directly or indirectly participate in the
consideration or determination by the Foundation of any
question affecting--
``(A) any direct or indirect financial interest of
the individual; or
``(B) any direct or indirect financial interest of
any business organization or other entity of which the
individual is an officer or employee or in which the
individual has a direct or indirect financial interest.
``(4) Audits; availability of records.--The Foundation
shall--
``(A) provide for biennial audits of the financial
condition of the Foundation; and
``(B) make such audits, and all other records,
documents, and other papers of the Foundation,
available to the Secretary and the Comptroller General
of the United States for examination or audit.
``(5) Reports.--
``(A) Not later than February 1 of each fiscal
year, the Foundation shall publish a report describing
the activities of the Foundation during the preceding
fiscal year. Each such report shall include for the
fiscal year involved a comprehensive statement of the
operations, activities, financial condition, and
accomplishments of the Foundation.
``(B) With respect to the financial condition of
the Foundation, each report under subparagraph (A)
shall include the source, and a description of, all
gifts to the Foundation of real or personal property,
and the source and amount of all gifts to the
Foundation of money. Each such report shall include a
specification of any restrictions on the purposes for
which gifts to the Foundation may be used.
``(C) The Foundation shall make copies of each
report submitted under subparagraph (A) available 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.
``(j) Federal Funding.--
``(1) Authority for annual grants.--
``(A) The Secretary, acting through the Director of
the National Institutes of Health, shall for each of
the fiscal years 1994 through 1996, make a grant to the
Foundation.
``(B) A grant under subparagraph (A) may be
expended only for the purpose of the administrative
expenses of the Foundation.
``(C) A grant under subparagraph (A) may not be
expended to provide amounts for the fund established
under subsection (c).
``(2) Funding for grants.--
``(A) For the purpose of grants under paragraph
(1), there is authorized to be appropriated $500,000
for each of the fiscal years 1994 through 1996.
``(B) For the purpose of grants under paragraph
(1), the Secretary may for each fiscal year make
available not more than $500,000 from the amounts
appropriated for the fiscal year for the programs of
the National Institutes of Health. Such amounts may be
made available without regard to whether amounts have
been appropriated under subparagraph (A).''.
TITLE XVIII--RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY
SYNDROME
SEC. 1801. REVISION AND EXTENSION OF VARIOUS 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 ``and 1991'' and
inserting ``through 1996'';
(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 the part heading for part D, by striking ``Director
of the National Institutes of Health'' and inserting ``Office
of AIDS Research'';
(7) in section 2351--
(A) by redesignating subsections (a), (b) and (c)
as subsections (b), (d) and (e), respectively;
(B) by striking subsection (a) and inserting the
following new subsection:
``(a) In General.--In carrying out research with respect to
acquired immune deficiency syndrome, the Secretary, acting through the
Director of the National Institutes of Health--
``(1) shall establish an office to be known as the Office
of AIDS Research, which Office shall be headed by a Director
who shall be--
``(A) appointed by the Secretary;
``(B) determined by the Secretary to be an
individual who is an outstanding scientist and a highly
skilled administrator; and
``(C) the primary Federal official responsible for
the conduct of AIDS-related research at the National
Institutes of Health; and
``(2) shall provide administrative support and support
services to the Director of such Office.'';
(C) in subsection (b) (as so redesignated)--
(i) by striking the subsection designation
and all that follows through paragraph (1) and
inserting in lieu thereof the following:
``(b) Activities of the Office of AIDS Research.--
``(1) In general.--The Secretary, acting through the
director of the Office of AIDS Research, shall ensure that AIDS
research activities are coordinated across and throughout the
institutes, centers, and divisions of the National Institutes
of Health.
``(2) General duties.--The Director of the Office of AIDS
Research shall, based upon a strategic plan as defined in
paragraph (3), develop and implement a budget for AIDS-related
research at the National Institutes of Health and coordinate
all AIDS-related research activities conducted at the
institutes, centers, and divisions of the National Institutes
of Health, and conduct evaluations on all such programs.
``(3) Strategic plan.--
``(A) Development.--The Director of the Office of
AIDS Research shall, with the advice of the directors
of the institutes, centers, and divisions of the
National Institutes of Health, and in consultation with
the advisory council established in paragraph (5) and
the coordinating groups established in subparagraph
(B), develop and implement a comprehensive, long-range
plan for the conduct and support of such research by
the National Institutes of Health. Such plan shall be
updated annually, and shall--
``(i) determine and prioritize among
critical scientific AIDS-related questions;
``(ii) based upon such determinations,
specify the range of objectives to be achieved,
the date the objectives are expected to be
achieved, and provide an estimate of the
resources needed to achieve the objectives by
such date;
``(iii) evaluate the sufficiency of
existing AIDS research programs to meet such
objectives, and establish standard evaluation
criteria, timelines and objectives for future
program evaluation activities; and
``(iv) make recommendations for changes and
necessary resource allocation in and among such
programs.
``(B) Coordinating groups.--The Director of the
Office of AIDS Research shall establish AIDS
coordinating groups for each research discipline within
the AIDS research program, composed of representatives
of relevant agencies of the National Institutes of
Health and qualified extramural scientists, to evaluate
and assess the efforts of the AIDS Research Program at
the National Institutes of Health, to advise on the
development of the strategic plan described in
subparagraph (A), and to determine the extent to which
such efforts are in accordance with such strategic
plan.
``(4) Coordination.--The Director of the Office of AIDS
Research shall act as the primary Federal official with
responsibility for overseeing all AIDS-related research efforts
undertaken 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-related research and the
clinical treatment of AIDS and its related conditions,
to these various agencies for dissemination to affected
communities and health care providers.
``(5) Advisory council.--
``(A) Establishment.--The Director of the Office of
AIDS Research shall establish an advisory council to be
known as the Office of AIDS Research Advisory Council
(hereafter referred to as the ``Council''), which shall
serve to replace the AIDS Program Advisory Committee
which is operating on the date of enactment of this
subsection.
``(B) Composition.--The Council shall be composed
of biomedical, behavioral, and social scientists, and
representatives of diverse HIV affected communities,
and shall be appointed by the Director.
``(C) Authority.--The Council shall, consistent
with section 406--
``(i) advise the Director of the Office of
AIDS Research and make recommendations
concerning the development of the AIDS-related
research budget, and the development and
implementation of the strategic plan for AIDS-
related research at the National Institutes of
Health;
``(ii) provide the second level of peer
review for awards made directly to the Office
of AIDS Research from the discretionary fund
described in paragraph (7); and
``(iii) carry out such other activities
determined appropriate by the Director of the
Office of AIDS Research.
``(6) Budgetary authority.--The Director of the Office of
AIDS Research shall--
``(A) in consultation with the advisory council
established under paragraph (5) and based upon budget
requests and additional advice from the directors of
the institutes, centers, and divisions of the National
Institutes of Health, prepare and submit, directly to
the President for review and transmittal to Congress,
an annual budget estimate for the AIDS-related research
program conducted within the agencies of the National
Institutes of Health, after reasonable opportunity for
comment (but without change) by the Secretary and the
Director of the National Institutes of Health;
``(B) receive from the President and the Office of
Management and Budget directly all AIDS-related
research funds appropriated by Congress for obligation
and expenditure by the agencies of the National
Institutes of Health in accordance with the strategic
plan developed under paragraph (3)(A); and
``(C) distribute AIDS research funding to the
various institutes, centers, and divisions of the
National Institutes of Health in accordance with the
strategic plan.
``(7) Discretionary fund.--
``(A) Availability of funds.--The Secretary shall
ensure that not to exceed 25 percent of the funds
available in excess of the amount of baseline AIDS
research spending during the previous fiscal year, but
in no event less than $50,000,000 each fiscal year, be
made available to the Director of the Office of AIDS
Research for the establishment of an AIDS research
discretionary fund.
``(B) Use.--The Director of the Office of AIDS
Research, in consultation with the advisory council
established under paragraph (5), shall use amounts in
the AIDS research discretionary fund to--
``(i) fund emergency AIDS research
programs;
``(ii) fund programs for the conduct of
research aimed at filling gaps that exist in
existing research programs;
``(iii) conduct conferences, convene
committees, hold meetings or carry out other
activities determined appropriate by the
Director.
``(C) Reduction in administrative impediments.--
Notwithstanding any other provision of law, with
respect to the number of full-time equivalent
individuals employed, the Director of the Office of
AIDS Research shall be permitted to authorize the
employment of such full-time equivalent individuals to
perform AIDS-related research through the agencies of
the National Institutes of Health.
``(c) Other Duties.--The director of the office--''; and
(ii) by redesignating paragraphs (2)
through (8) (as such paragraphs existed one day
prior to the date of enactment of this Act) as
paragraphs (1) through (7), respectively; and
(C) in subsection (c) (as added by the amendment
made by subparagraph (B)) by striking ``for the
appropriate national research institute of the National
Institutes of Health'' in paragraph (4) (as so
designated by the amendments made by subparagraph (B));
(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.'';
(9) in section 2315(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.'';
(10) 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.''; and
(11) 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.''.
TITLE XIX--STUDIES
SEC. 1901. ACQUIRED IMMUNE DEFICIENCY SYNDROME.
(a) Certain Drug-Release Mechanisms.--
(1) The Secretary of Health and Human Services shall,
subject to paragraph (2), enter into a contract with a public
or nonprofit private entity to conduct a study for the purpose
of determining, with respect to acquired immune deficiency
syndrome, the impact of parallel-track drug-release mechanisms
on public and private clinical research, and on the activities
of the Commissioner of Food and Drugs regarding the approval of
drugs.
(2) The Secretary of Health and Human Services shall
request the Institute of Medicine of the National Academy of
Sciences to enter into the contract under paragraph (1) to
conduct the study described in such paragraph. If such
Institute declines to conduct the study, the Secretary shall
carry out paragraph (1) through another public or nonprofit
private entity.
(b) Third-Party Payments Regarding Certain Clinical Trials.--The
Secretary of Health and Human Services 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; and
(2) developing recommendations regarding such policies.
(c) Advisory Committees.--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 determining--
(1) whether the activities of the various advisory
committees established in the National Institutes of Health
regarding acquired immune deficiency syndrome are being
coordinated sufficiently; and
(2) whether the functions of any of such advisory
committees should be modified in order to achieve greater
efficiency.
(d) 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) 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 System established under section 1428 of
the Food and Agriculture Act of 1977 (7 U.S.C. 3178), 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
May 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
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 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. The Secretary shall
submit the report not later than 12 months after the date of the
enactment of this Act.
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. REPORT CONCERNING LEADING CAUSES OF DEATH.
(a) Report.--The Secretary of Health and Human Services shall, not
later than February 1, 1993, prepare a report that lists--
(1) the 20 illnesses that, in terms of mortality, number of
years of expected life lost, and of number of preventable years
of life lost, are the leading causes of death in the United
States and the number of deaths from each such cause, the age-
specific and age-adjusted death rates for each such cause, the
death rate per 100,000 population for each such cause, the
percentage of change in cause specific death rates for each age
group, and the percentage of total deaths for each such cause;
(2) the amount expended by the Department of Health and
Human Services for research, prevention, and education with
respect to each of the 20 illnesses described in paragraph (1)
for the most recent year for which the actual expenditures are
known;
(3) an estimate by the Secretary of the amount to be
expended on research, prevention, and education with respect to
each of the 20 illnesses described in paragraph (1) for the
year for which the report is prepared; and
(4) with respect to the years specified in paragraphs (2)
and (3), the percentage of the total of the annual expenditures
for research, prevention, and education on the 20 illnesses
described in paragraph (1) that are attributable to each
illness.
(b) Submission to Congress.--The Secretary of Health and Human
Services shall submit the report required under subsection (a),
together with relevant budget information, to the Committee on Energy
and Commerce and the Committee on Appropriations of the House of
Representatives and the Committee on Labor and Human Resources and the
Committee on Appropriations of the Senate.
SEC. 1908. RELATIONSHIP BETWEEN THE CONSUMPTION OF LEGAL AND ILLEGAL
DRUGS.
(a) In General.--The Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, 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).
TITLE XX--MISCELLANEOUS PROVISIONS
SEC. 2001. DESIGNATION OF SENIOR BIOMEDICAL RESEARCH SERVICE IN HONOR
OF SILVIO O. CONTE, AND 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 750 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 (hereafter 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. TECHNICAL CORRECTIONS.
(a) Title III.--Subsection (c) of section 316 of the Public Health
Service Act (42 U.S.C. 247a(c)) is repealed.
(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 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''.
(d) 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''.
(e) 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''.
(f) Department.--Section 202 of the Public Health Service Act (42
U.S.C. 203) is amended--
(1) by striking ``Health, Education, and Welfare'' and
inserting ``Health and Human Services'';
(2) by striking ``Surgeon General'' the second and
subsequent times that such term appears and inserting
``Secretary''; and
(3) by inserting ``, and the Agency for Health Care Policy
and Research'' before the first period.
(g) 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''.
SEC. 2003. 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 in lieu
thereof ``a biennial''.
SEC. 2004. MASTER PLAN FOR PHYSICAL INFRASTRUCTURE FOR RESEARCH.
Not later than 90 days 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 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. 2005. 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 new
heading:
``Part A--Administration''; and
(5) by inserting before section 231 (as redesignated by
paragraph (2) of this subsection) the following new 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. 2006. 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 1997.''; and
(2) in the second sentence, by striking ``Out of any
amounts used'' and inserting ``Of the amounts appropriated
under the preceding sentence''.
SEC. 2007. 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 April 15,
1993.
SEC. 2008. 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 and
biomaterials sciences;
(2) evaluating whether that commitment is sufficient to
maintain the innovative edge that the United States has in
these technologies; and
(3) evaluating the need to modify the structure of the
National Institutes of Health or any other Federal agency to
achieve a greater commitment to innovation in bioengineering,
and 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 (such
as the National Science Foundation, Veterans Administration, Department
of Defense, National Aeronautics and Space Administration, and the
White House Office of Science and Technology Policy).
(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.
TITLE XXI--EFFECTIVE DATES
SEC. 2101. EFFECTIVE DATES.
Subject to section 155, this Act and the amendments made by this
Act take effect upon the date of the enactment of this Act.
<all>
S 1 IS----2
S 1 IS----3
S 1 IS----4
S 1 IS----5
S 1 IS----6
S 1 IS----7
S 1 IS----8
S 1 IS----9
S 1 IS----10
S 1 IS----11
S 1 IS----12
S 1 IS----13