National Institute on Population and Human Reproduction Act - Amends the Public Health Service Act to add the National Institute on Population and Human Reproduction (NIPHR) to the list of agencies of the National Institutes of Health (NIH). Establishes the Institute to conduct and support basic and applied research, research training, health information, and related programs with respect to matters of human reproduction and population sciences.
Requires that the Director of the NIPHR: (1) be appointed by the Secretary of Health and Human Services; and (2) also serve as an Associate Director of the National Science Policy Committee for Research on Human Development.
Establishes the National Population and Human Reproduction Advisory Council.
Sets forth the duties of the Director of the NIPHR. Authorizes the Director to provide for the establishment of centers for basic and applied research and other activities.
Prohibits the provision of funds under any provision of law under any contract with a profit-making entity to support any contraceptive development research in excess of 50 percent of the research cost covered by the contract unless the contract provides that the United States retains all property rights to the research results.
Authorizes appropriations for FY 1986 through 1988. Requires at least 25 percent of the annual appropriation to be spent for research in contraceptive development and evaluation.
Establishes a National Institute of Child Health and Human Development (NICHHD) to conduct and support basic and applied research, research training, health information, and related programs with respect to human pregnancy and infancy as well as the biological and psychosocial problems of human development, with special emphasis on the problems of the mentally retarded. Requires the NICHHD to: (1) study all factors related to the unmet health and development needs of mothers and children; and (2) be concerned with health problems occurring at the earliest stages of development through adulthood.
Requires that the Director of the NICHHD: (1) be appointed by the Secretary; and (2) also serve as an Associate Director of the National Science Policy Committee for Research on Human Development.
Establishes the National Advisory Council for Mothers and Children.
Sets forth the duties of the Director of the NICHHD. Authorizes the Director to provide for the establishment of centers for basic and applied research and other activities relating to programs for research involving maternal and child health and development.
Authorizes appropriations for FY 1986 through 1988.
Authorizes the Directors of the NIPHR and the NICHHD, under policies established by the Director of the NIH, to enter into cooperative agreements for planning, establishing, acquiring or strengthening, and providing basic operating support for existing or new centers for basic and applied research and activities as provided for in this Act. Allows payments under the agreements to be used for construction and repair, staffing and other basic operating costs, research training, and demonstration purposes.
Limits support for a center under these provisions to three years. Authorizes extensions of not more than three years each after review by a scientific review group. Declares that priority for support will be given to entities and research centers which have demonstrated a capacity to focus interdisciplinary skills and to concentrate personnel and other resources in the resolution of specific problems.
Requires the Directors of the NIPHR and the NICHHD, by regulation, to provide for scientific review of all research grants and programs over which they have authority by establishing and utilizing peer review committees established with the approval of the Advisory Councils to their Institutes. Makes members of a review committee ineligible to participate in the projects reviewed by the committee. Declares that no research activity involving any human subjects will be undertaken unless in compliance with regulations of the Secretary concerning human subject research.
Establishes in the NIH the National Science Policy Committee for Research on Human Development (Committee) to coordinate the conduct and support of basic and applied research, research training, health information, and related programs with respect to human reproduction and population research, maternal and child health, and human development. Requires the Committee to promote the worldwide distribution and public distribution of the results of this research among researchers around the world.
Requires that the Director of the Committee: (1) be appointed by the President for a period of at least six years; and (2) also serve as an Associate Director of the NIH.
Requires the Director to prepare and submit, directly to the President for review and transmittal to the Congress, coordinated annual budget estimates for the NIPHR and the NICHHD, after reasonable opportunity for comment, but without change, by the Secretary, the Director of the NIH, and the Committee shall receive from the President and the Office of Management and Budget directly all funds appropriated by the Congress for obligation and expenditure for the two Institutes.
Requires such funds as may be necessary for the direct operations of the Committee to be drawn from the direct operations and program management budgets of the NIPHR and the NICHHD.
Amends the Public Health Service Act to remove provisions relating to the National Institute of Child Health and Human Development.
HR 2774 IH 101st CONGRESS 1st Session H. R. 2774 To amend the Public Health Service Act to provide for the establishment of a National Institute on Population and Human Reproduction to be coordinated with the National Institute of Child Health and Human Development by a National Science Policy Committee for Research on Human Development, and for other purposes. IN THE HOUSE OF REPRESENTATIVES June 28, 1989 Mr. MOODY introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Public Health Service Act to provide for the establishment of a National Institute on Population and Human Reproduction to be coordinated with the National Institute of Child Health and Human Development by a National Science Policy Committee for Research on Human Development, 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. This Act may be cited as the `National Institute on Population and Human Reproduction Act'. SEC. 2. ESTABLISHMENT OF NATIONAL INSTITUTE ON POPULATION AND HUMAN REPRODUCTION. Title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) is amended-- (1) in section 401(b)(1), by adding at the end the following new subparagraph: `(N) The National Institute on Population and Human Reproduction.'; (2) by redesignating parts D through G as parts E through H, respectively; (3) by redesignating sections 465 through 499 as sections 471 through 499F, respectively; and (4) by inserting after part C the following new part: `Part D--National Institute on Population and Human Reproduction and National Institute of Child Health and Human Development `Subpart 1--Establishment of Institutes `NATIONAL INSTITUTE ON POPULATION AND HUMAN REPRODUCTION `SEC. 465. (a) There is established a National Institute on Population and Human Reproduction (hereafter in this section referred to as the `Institute') to conduct and support basic and applied research, research training, health information and related programs with respect to matters of human reproduction and population sciences such as biomedical research in reproductive biology including diseases of the male and female which affect fertility; research in the development of methods of male and female fertility control and infertility treatment; research in the medical and other effects of methods of male and female fertility control and infertility treatment; research in the organization, delivery, and dissemination of methods of and services for male and female fertility control and infertility treatment; and research in the social, behavioral, and demographic sciences as to the psychological, social, and economic determinants and consequences of population processes, structure, growth, distribution, and change; and their effects on human health and well-being. `(b) The Director of the Institute shall be appointed by the Secretary. The Director of the Institute shall also serve as an Associate Director of the National Science Policy Committee for Research on Human Development. `(c)(1) With regard to the activities of the Institute, there is established a National Population and Human Reproduction Advisory Council (hereafter in this section referred to as the `Council') to advise, consult with, and make recommendations to the Director of the Institute. The Council shall meet at least three times each year. `(2) The Council shall be composed of the Director of the Institute, who shall serve as Chairman, the Director of the National Science Policy Committee for Research on Human Development and at least ten members appointed by the Secretary. At least five of such members shall include leading scientific and medical authorities in basic and applied research and training in the biomedical, behavioral, social, and demographic sciences; and at least five of such members shall be providers of fertility control methods and services, members of the general public, including representatives of women's groups, youth groups, consumer groups, and minority groups, and experts in law, economics, and relevant fields. The Secretary may designate additional ex officio members as deemed necessary to carry out the Council's functions. `(d) The Director of the Institute shall carry out the purposes of section 301 with respect to the conduct and support of research in matters of human reproduction and population sciences such as reproductive biology, methods of male and female fertility control and infertility treatment and in the social, behavioral and demographic sciences. In carrying out the program of the Institute, the Director shall-- `(1) with the advice of the Committee and the Council, plan and develop an expanded, intensified, and coordinated population sciences research program coordinated with the programs of the National Institute for Mothers and Children, related programs of the other research institutes, and other Federal and non-Federal programs capable of addressing needs and problems of the human reproduction and population sciences fields; `(2) expeditiously utilize existing research facilities and personnel of the National Institutes of Health for accelerated exploration of opportunities in areas of special promise to advance knowledge in the fields comprising human reproduction and population sciences; `(3) encourage and coordinate with human reproduction and population science research by commercial entities where there is evidence of a particular capability for such research and enter into contracts with such commercial entities; `(4) make grants and enter into contracts with public or private entities and with individuals engaged in scientific research involving human reproduction and the population sciences; `(5) establish, support, and maintain programs of training in the appropriate sciences and related disciplines to provide an expanded and continuing workforce from which to select investigators and health professions personnel for participation in basic and applied research involving the human reproduction and population sciences, including where appropriate the use of training stipends, fellowships, career awards, grants to public and nonprofit private entities, and contracts with public and private entities, and the Director shall take appropriate steps to ensure the education and training of adequate numbers of research personnel in the field of human reproduction and population sciences; `(6) call special meetings of the Council at such times and in such places as he deems necessary in order to consult with, obtain advice from, and accomplish all other actions necessary without delay to gain maximum benefit from new scientific or technical findings; and `(7) establish an information office on human reproduction and the population sciences to collect, catalog, and analyze all information as to studies which have been and are being carried on in the United States and elsewhere in reproductive biology, methods of male and female fertility control and infertility treatment, and behavioral, social, and demographic sciences as they relate to population matters and the results and developments of such studies; and disseminate such information insofar as feasible through publications, conferences, meetings, and other forms of communication for the use and benefit of any person concerned with such information in any country. `(e) The Director of the Institute is authorized to provide for the establishment of centers for basic and applied research and other activities relating to human reproduction, male and female fertility control and infertility treatment, delivery of male and female fertility control and infertility treatment services, population growth, distribution, density changes, and other factors which affect population dynamics. `(f) No funds shall be provided under this section or any other provision of law under any contract with a profit-making entity to support any contraceptive development research in excess of 50 per centum of the total cost attributed to the research activity covered by such contract unless such contract expressly provides that the United States will retain all property rights to the products of such research. `(g) There are authorized to be appropriated $140,000,000 for the fiscal year ending September 30, 1986; $160,000,000 for the fiscal year ending September 30, 1987; and $180,000,000 for the fiscal year ending September 30, 1988, for extramural research, intramural research, direct operations and program management of the Institute. Not less than 25 percent of the annual appropriation shall be spent for research in contraceptive development and evaluation. `NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT `SEC. 466. (a) There is established a National Institute of Child Health and Human Development (hereafter in this section referred to as the `Institute') to conduct and support basic and applied research, research training, health information and related programs with respect to the advancement of knowledge on human pregnancy and infancy as well as the examination of the problems of human development from a biological and psychosocial standpoint with special emphasis on the causes and amelioration of the problems of the mentally retarded. The Institute shall study all factors related to the unmet health and development needs of mothers and children and shall be concerned with health problems occurring at the earliest stages of development through adulthood. `(b) The Director of the Institute shall be appointed by the Secretary. The Director of the Institute shall also serve as an Associate Director of the National Science Policy Committee for Research on Human Development. `(c)(1) With regard to the activities of the Institute, there is established a National Advisory Council for Mothers and Children (hereafter in this section referred to as the `Council') to advise, consult with, and make recommendations to the Director of the Institute. The Council shall meet at least three times each year. `(2) The Council shall be composed of the Director of the Institute, who shall serve as Chairman, the Director of the National Science Policy Committee for Research on Human Development, and at least ten members appointed by the Secretary. At least five of such members shall include leading scientific and medical authorities in basic and applied research and training in the biomedical, behavioral, social, and demographic sciences; and at least five of such members shall be members of the general public, including representatives of women's groups, youth groups, consumer groups and minority groups, and experts in law, economics, and relevant fields. The Secretary may designate additional ex officio members as deemed necessary to carry out the Council's functions. `(d) The Director of the Institute shall carry out the purposes of section 301 with respect to the conduct and support of research in the advancement of knowledge on pregnancy and infancy as well as to examine the problems of human development, including research on mental retardation as well as research which relates specifically to sudden infant death syndrome. In carrying out the program of the Institute the Director shall-- `(1) with the advice of the Committee and the Council, plan and develop an expanded, intensified, and coordinated program for research for maternal and child health coordinated with the programs of the National Institute on Population and Human Reproduction, related programs of the other research institutes, and other Federal and non-Federal programs capable of addressing needs and problems in research for maternal and child health and development; `(2) expeditiously utilize existing research facilities and personnel of the National Institutes of Health for accelerated exploration of opportunities in areas of special promise to advance knowledge in the fields comprising programs for research for maternal and child health and development; `(3) encourage and coordinate with programs for research for mothers and children by commercial entities where there is evidence of a particular capability for such research, and enter into contracts with such commercial entities; `(4) make grants and enter into contracts with public or private entities and with individuals engaged in scientific research for maternal and child health and development; `(5) establish, support and maintain programs of training in the appropriate sciences and related disciplines to provide an expanded and continuing manpower base from which to select investigators and health professions personnel for participation in basic and applied research involving maternal and child health and development, including where appropriate the use of training stipends, fellowships, career awards, grants to public and nonprofit private entities, and contracts with public and private entities and the Director shall take appropriate steps to insure the education and training of adequate numbers of research personnel in the field of mothers and children; `(6) call special meetings of the Council at such times and in such places as he deems necessary in order to consult with, obtain advice from, and accomplish all other actions necessary without delay to gain maximum benefit from new scientific or technical findings; and `(7) establish an information office on programs for research for mothers and children to collect, catalog, and analyze all information as to studies which have been and are being carried on in the United States and elsewhere in the advancement of knowledge of pregnancy and infancy, the problems of human development with special reference to the causes and amelioration of the problems of the mentally retarded and the results and developments of such studies; and disseminate such information insofar as feasible through publications, conferences, meetings, and other forms of communication for the use and benefit of any person concerned with such information in any country. `(e) The Director of the Institute is authorized to provide for the establishment of centers for basic and applied research and other activities relating to programs for research involving maternal and child health and development. `(f) There are authorized to be appropriated $178,000,000 for the fiscal year ending September 30, 1986; $190,000,000 for the fiscal year ending September 30, 1987; and $205,000,000 for the fiscal year ending September 30, 1988, for extramural research, intramural research, direct operations and program management. `Subpart 2--General Provisions `ADVISORY COUNCILS `SEC. 467. (a) Each appointed member of the Advisory Councils to the National Institute on Population and Human Reproduction and to the National Institute of Child Health and Human Development shall hold office for a term of four years, except that any member appointed to fill a vacancy occurring prior to expiration of the term which his predecessor was appointed shall be appointed for the remainder of such term and except that, of the members first appointed, three shall hold office for a term of three years, three shall hold office for a term of two years, and three shall hold office for a term of one year, as designated by the Secretary at the time of appointment. None of such members shall be eligible for reappointment until a year has elapsed since the end of his preceding term. `(b) Members of the Advisory Councils to the National Institute on Population and Human Reproduction and the National Institute of Child Health and Human Development who are not officers or employees of the United States shall receive for each day they are engaged in the performance of the duties of the Council compensation at a rate not to exceed daily equivalent of the annual rate in effect for GS-18 of the General Schedule, including traveltime; and all members, while so serving away from their homes or regular places of business, may be allowed travel expenses, including per diem in lieu of subsistence, in the same manner as such expenses are authorized by section 5703, title 5, United States Code, for persons in the Government service employed intermittently. `(c) The Directors of the National Institute on Population and Human Reproduction and the National Institute of Child Health and Human Development shall make available to their Advisory Councils such staff, information, and other assistance as it may require to carry out its activities. `(d) Each Advisory Council established under subpart 1 shall assume all or such part as the Director of the Institute it serves may specify on the duties, functions, and powers of the National Advisory Health Council relating to the research or research training projects with which the Council is concerned and such portion as the Director of the Institute may specify of the duties, functions, and powers of any other advisory council or committee established under this Act relating to such projects. `CENTERS `SEC. 468. (a) The Directors of the National Institute on Population and Human Reproduction and the National Institute of Child Health and Human Development, under policies established by the Director of the National Institutes of Health, may enter into cooperative agreements with public or private nonprofit agencies or institutions to pay all or part of the cost of planning, establishing, acquiring or strengthening, and providing basic operating support for existing or new centers for the research and activities described in sections 465(e) and 466(e). Federal payments under this subsection in support of such cooperative agreements may be used for (1) construction and repair, (2) staffing and other basic operating costs as are required for research, (3) research training, and (4) demonstration purposes. Support of a center under this section may be for a period of not to exceed three years and may be extended by the Director of the Institute for additional periods of not more than three years each, after review of the operations of such center by an appropriate scientific review group established by the Director of the Institute. `(b) Priority for support under subsection (a) will be given to public and private nonprofit entities and research centers which have demonstrated a capacity to focus interdisciplinary skills and to concentrate personnel and other resources in the resolution of specific problems. `PEER REVIEW `SEC. 469. (a) The Directors of the National Institute on Population and Human Reproduction and the National Institute of Child Health and Human Development shall, by regulation, provide for proper scientific review of all research grants and programs over which they have authority by establishing and utilizing, to the extent possible, appropriate peer review committees established with the approval of the Advisory Councils to their Institutes and composed principally of non-Federal scientists and other experts as may be required, to provide initial and continuing evaluations and review of the planning, administration and progress of research grants and programs of the Institutes. `(b) To avoid conflicts of interests, members of a scientific peer review committee shall not be eligible to participate in the projects reviewed by the Committee. `(c) Scientific peer review committees may schedule meetings and make site visits to consider regular or special reports of the research activity of the Institutes for which such committee has been established. `(d) Such scientific review committees shall report their findings and recommendations to the Directors of the Institutes and to the Advisory Councils to the Institutes. `(e) No research activity in connection with such projects or programs which involves any human subjects will be undertaken unless such projects or programs are in compliance with regulations of the Secretary for the protection of human subjects of research. `Subpart 3--Establishment of Committee `ESTABLISHMENT OF THE NATIONAL SCIENCE POLICY COMMITTEE FOR RESEARCH ON HUMAN DEVELOPMENT `SEC. 470. (a) There is established in the National Institutes of Health a National Science Policy Committee for Research on Human Development (hereafter in this part referred to as the `Committee') for the purpose of coordinating the conduct and support of basic and applied research, research training, health information, and related programs with respect to human reproduction and population research, maternal and child health, human development, including research and research training in the biomedical and social sciences relating to human fertility and infertility and in the special health problems and requirements of mothers and children with regard to the processes of human growth and development, including prenatal development. The Committee shall also promote the worldwide distribution and public distribution of the results of this research among researchers around the world. `(b)(1) The Director of the Committee shall be appointed by the President for a period of no less than six years. The Director of the Committee shall also serve as an Associate Director of the National Institutes of Health. `(2)(A) The Committee shall be chaired by the Director, and its membership shall consist of the Director of the National Institute on Population and Human Reproduction, the Director of the National Institute of Child Health and Human Development, and ten public representatives appointed by the President. In addition, two members each of the advisory councils of the National Institute on Population and Human Reproduction and the National Institute of Child Health and Human Development, elected by the councils, shall serve as ex officio members of the Committee. `(B) In addition, the Secretary, the Director of the National Institutes of Health, the Director of the Office of Science and Technology Policy, and the chief medical officer of the Veterans' Administration (or their designee), and a medical officer designated by the Secretary of Defense, shall be ex officio members of the Committee. `(C) The ten members appointed by the President shall include leading scientific and medical authorities in basic and applied research and training in the biomedical, behavioral, and social and demographic sciences. Not less than four of the members shall be representatives of providers and consumers of services related to male and female fertility, maternal, and child health. Each appointed member of the Committee shall be appointed from among persons who by virtue of their training, experience, and background are especially qualified to appraise the programs of the two institutes. `(D) Appointed members shall be appointed for four-year terms, except that of the members first appointed, six shall be appointed for a term of two years, as designated by the President at the time of the appointment. `(E) Any member appointed to fill a vacancy occurring prior to expiration of the term for which his predecessor was appointed shall serve only for the remainder of such term. Appointed members shall be eligible for reappointment and may serve after the expiration of their terms until their successors have taken office. `(F) A vacancy on the Committee shall not affect its activities, and eight members thereof shall constitute a quorum. `(G) The Committee shall meet at the call of the Director, but not less often than three times a year and shall advise and assist the Director of the Committee with respect to the coordination of the programs of the National Institute on Population and Human Reproduction and the National Institute of Child Health and Human Development. `(H) The Director of the Committee shall designate a member of the staff of the two Institutes to act as Executive Secretary of the Committee. `(I) The Committee may hold such hearings, take such testimony, and sit and act at such times and places as the Committee deems advisable to investigate programs and activities of the National Institute on Population and Human Reproduction and National Institute of Child Health and Human Development. `(J) Members of the Council who are not officers or employees of the United States shall receive for each day they are engaged in the performance of the duties of the Council compensation at rates not to exceed the daily equivalent of the annual rate in effect for grade GS-18 of the General Schedule, including traveltime; and all members, while so serving away from their homes or regular places of business, may be allowed travel expenses, including per diem in lieu of subsistence, in the same manner as such expenses are authorized by section 5703, title 5, United States Code, for persons in the Government service employed intermittently. `(K) The Directors of the two Institutes shall make available to the Committee such staff, information, and other assistance as it may require to carry out its activities. `(3) The Director shall prepare and submit, directly to the President for review and transmittal to Congress, coordinated annual budget estimates for the National Institute on Population and Human Reproduction and the National Institute of Child Health and Human Development, after reasonable opportunity for comment (but without change) by the Secretary, the Director of the National Institutes of Health, and the Committee shall receive from the President and the Office of Management and Budget directly all funds appropriated by the Congress for obligation and expenditure for the two institutes. `(c) The Director of the Committee shall, within four months after the end of each fiscal year, prepare in consultation with the Committee and submit to the President for transmittal to the Congress a report on the activities, progress, and accomplishments of the National Institute on Population and Human Reproduction and the National Institute of Child Health and Human Development during the preceding calendar year and a plan for the two Institutes during the next five years, which shall set forth research priorities, the staffing and Federal funding requirements to carry out these priorities, and their relationship to and coordination with the programs of the other Institutes of NIH. `(d) Such funds as may be necessary for the direct operations of the Committee shall be drawn from the direct operations and program management budgets of the National Institute for Population and Human Reproduction and the National Institute of Child Health and Human Development.'. SEC. 3. CONFORMING AMENDMENT. Part C of title IV of the Public Health Service Act (42 U.S.C. 285 et seq.) is amended by striking subpart 7. SEC. 4. EFFECTIVE DATE. The amendments made by this Act shall take effect October 1, 1989, or upon the date of the enactment of this Act, whichever occurs later.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health and the Environment.
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