Health Research Extension Act of 1983

Summary

Health Research Extension Act of 1983 - Amends title IV of the Public Health Service Act (National Research Institutes) to establish as an agency of the Public Health Service the National Institutes of Health (NIH) (abolished as a statutory entity by Reorganization Plan No. 3 of 1966) consisting of the following 12 categorical institutes: (1) the National Cancer Institute; (2) the National Heart, Lung, and Blood Institute; (3) the National Institute of Diabetes, and Digestive and Kidney Diseases; (4) the National Institute on Aging; (5) the National Institute of Allergy and Infectious Diseases; (6) the National Institute of Child Health and Human Development; (7) the National Institute of Dental Research; (8) the National Eye Institute; (9) the National Institute of Neurological and Communicative Disorders and Stroke; (10) the National Institute of General Medical Sciences; (11) the National Institute of Environmental Health Sciences; and (12) the National Institute of Arthritis and Musculoskeletal Diseases. Establishes as agencies within NIH: (1) the Division of Research Resources; (2) the National Library of Medicine; (3) the John E. Fogarty International Center for Advanced Study in the Health Sciences; (4) the Office of Medical Applications of Research; (5) the National Center for Health Services Research; (6) the National Center for Health Statistics; and (7) the National Institute for Occupational Safety and Health. Permits the Secretary of Health and Human Services to establish additional research institutes. Provides that: (1) the NIH shall be headed by a Director, who shall be appointed by the President by and with the advice and consent of the Senate; (2) the Secretary acting through the Director shall be responsible for the overall direction of NIH, including specified administrative and supervisory functions; and (3) the Director shall delegate certain program promotion and coordination functions to an Assistant Director including the formulation of a long-range disease Prevention Plan (the first Plan to be prepared by January 1, 1985). Prohibits human fetal experimentation unless: (1) necessary for the survival or meeting of the health needs of the fetus; or (2) the risk to the fetus is minimal and no other alternative is possible. Sets forth waiver provisions. Directs the Secretary to appoint a National Institutes of Health Advisory Board to: (1) advise and make recommendations to the Secretary and the Director; and (2) prepare a biennial report. Requires a biennial report to be submitted by the Secretary to the President and to Congress consisting of: (1) a description of the NIH's activities; (2) the biennial report of the Advisory Board; and (3) the biennial reports of the directors of each of the national research institutes and their advisory councils. Requires the Director of NIH to establish Centers for Research and Demonstration of Health Promotion and Disease Prevention (ten in FY 1984, ten in FY 1985, and five in FY 1986) to undertake research and demonstration projects in health promotion, disease prevention, and improved methods of appraising health hazards and risk factors. Provides that the Director of the National Cancer Institute shall be appointed by the President, and the Directors of the other national research institutes shall be appointed by the Secretary. Sets forth the general duties of the Secretary (acting through the Director of each national research institute) with respect to the aspect of human health for which the institutes were established. Authorizes activities and programs to be supported through grants and contracts approved by each Director. States that each institute shall have an Assistant Director for Prevention. Directs the Secretary to appoint an advisory council for each institute. Sets forth the duties of such advisory councils, including the periodic review of research. Requires the director of each institute to prepare a biennial report. Authorizes specified appropriations for FY 1984 through 1986. States the general purpose and defines the scope of the National Cancer Institute. Requires that cancer control programs under the Institute include demonstration methods for disseminating cancer prevention information to the public. Directs the Secretary, through the Director of the Institute, to establish an information and education center to collect and disseminate information on cancer. Authorizes such Director to: (1) support production or distribution of therapeutic substances for cancer research, including biological materials, and set safety standards for their use; (2) with the approval of such Institute's advisory council, support certain cancer research by foreign nationals outside the United States, encourage collaborative research involving American and foreign participants, and train Americans abroad or foreign nationals in the United States; (3) support education and training programs; (4) coordinate certain research by industrial concerns; (5) hire experts and consultants; (6) acquire, repair, or construct facilities, including facilities in the District of Columbia; (7) appoint advisory committees; (8) enter into contracts, leases, or other transactions; and (9) submit an annual budget estimate to the President. Deletes the existing limitation on aggregate payments respecting cooperative agreements to establish cancer research and demonstration centers, and extends the period of support for a center to five years (with additional extensions of not more than five years). Eliminates the existing requirement that at least two members of the President's Cancer Panel be scientists or physicians, and requires the filling of vacancies within 90 days of their occurrence. States the general purpose and defines the scope of the National Heart, Lung, and Blood Institute. Requires the Secretary, through the Director of the Institute, to establish an information and education center to collect and disseminate information on research, treatment, and prevention of such diseases. Deletes the existing limitation on aggregate payments respecting research and demonstration centers for heart, blood vessel, lung, and blood diseases. States the general purpose of the National Institute of Diabetes and Digestive and Kidney Diseases. Establishes information clearinghouses, data systems, and Associate Director positions, advisory boards, interagency coordinating committees, advisory council subcommittees, and research and training centers. Requires a biennial Institute report. Establishes the National Institute of Arthritis and Musculoskeletal Diseases. Establishes an information clearinghouse and data system, arthritis and skin diseases coordinating committees, demonstration project grant authority, and multipurpose centers. Requires a biennial Institute report. Establishes a National Arthritis Advisory Board. Sets forth the general purpose of the National Institute on Aging. Transfers the responsibility for public information and education programs on aging from the Secretary to the Director of such Institute. Sets forth the general purposes of the National Institutes of: (1) Allergy and Infectious Diseases; (2) Child Health and Human Development (including grants to mental retardation research centers); (3) Dental Research; (4) Neurological and Communicative Disorders and Stroke; (5) General Medical Sciences; and (6) Environmental Health Sciences. Sets forth the general purpose of the National Eye Institutes. Establishes in the National Institute of Neurological and Communicative Disorders and Stroke an Interagency Committee on Spinal Cord Injury to develop and implement Federal initiatives in spinal cord regeneration research. Requires an annual report to Congress. Sets forth the general purposes of the Division of Research Resources, the John E. Fogarty International Center for Advanced Study in the Health Sciences, and the Office for Medical Applications of Research. Authorizes appropriations for National Research Service Awards through FY 1986. Limits the scope of the Institutional Review Board's authority to federally-financed research. Exempts research which does not involve human risk from such review authority. Requires the Director of NIH to establish procedures for periodic, technical, and scientific peer review of NIH research. States that such procedures shall require that: (1) the reviewing entity be given a written description of the research to be reviewed; and (2) such entity shall provide the advisory council of the institute involved with the results of such review. Requires grant or contract recipients to establish an administrative entity to review project reports of scientific fraud and to report any substantial allegations to the Secretary. Requires the Director of NIH to establish a process for handling such allegations. Provides for expedited grant procedures in cases of public health emergencies. Requires an annual report to the appropriate congressional committees regarding such actions. Requires the Secretary to establish animal research standards, including the formation of animal care committees. Requires NIH grant and contract recipients to meet such standards. Authorizes the Secretary to: (1) accept certain conditional gifts for the NIH or a national research institute; and (2) establish suitable memorials for donations of $50,000 or more. Terminates the National Advisory Health Council. Makes technical changes in specified provisions of the Public Health Service Act and other Federal health laws. Amends the Orphan Drug Act to eliminate the provision requiring the establishment of at least ten sickle cell disease centers. States that the National Library of Medicine shall be an agency of NIH (presently established as part of the Public Health Service). Extends authorizations of appropriations through FY 1986. Requires: (1) an NIH pertussis vaccines study (including comparisons with vaccines used abroad); and (2) such study to be completed and reported to Congress by April 1, 1984, or six months after enactment of this Act, whichever is later. Requires the Institute on Aging to conduct a study of personnel for the health needs of the elderly. Requires a report to the appropriate congressional committees by March 1, 1985. Provides for a study of the effects of commercialization on biomedical research. Requires completion of this study by September 30, 1985. Establishes an Interagency Committee on Learning Disabilities. Requires a report to Congress within 18 months. Terminates the Committee 90 days after such report is submitted. Requires the Secretary to conduct a study of: (1) the effectiveness of the national research institutes; and (2) the research programs of the National Institute of Diabetes and Digestive and Kidney Diseases. Prohibits the establishment of any new national research institute (excluding the National Institute of Arthritis and Musculoskeletal Diseases) for at least six months. Requires: (1) the National Institute of Diabetes and Digestive and Kidney Diseases to conduct research on diet therapy for kidney failure; and (2) a report to Congress by January 1, 1987. Authorizes pay increases and extended work schedules for Public Health Service nurses at NIH. Directs the Secretary to follow specified Office of Management and Budget guidelines in calculating biomedical and behavioral research costs. Establishes the National Commission on Orphan Diseases to evaluate public and private rare disease activities. Requires a report to the Secretary and to each House of Congress by September 30, 1985. Terminates such Commission 90 days after submitting such report. Authorizes FY 1984 and FY 1985 appropriations.

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Timeline

1. 24 March 1983

   Committee

   For Previous Action See H.R.1555.

   Source: Committee

2. 24 March 1983

   Introduced

   Referred to House Committee on Energy and Commerce.

   Source: IntroReferral

3. 24 March 1983

   Introduced

   Introduced in House

   Source: IntroReferral

4. 24 March 1983

   Introduced

   Introduced in House

   Source: IntroReferral

5. 3 May 1983

   Committee

   Committee Consideration and Mark-up Session Held.

   Source: Committee

6. 5 May 1983

   Committee

   Committee Consideration and Mark-up Session Held.

   Source: Committee

7. 10 May 1983

   Reported

   Ordered to be Reported (Amended).

   Source: Committee

8. 10 May 1983

   Committee

   Committee Consideration and Mark-up Session Held.

   Source: Committee

9. 16 May 1983

   Calendars

   Placed on Union Calendar No: 123.

   Source: Calendars

10. 16 May 1983

    Reported

    Reported to House (Amended) by House Committee on Energy and Commerce. Report No: 98-191.

    Source: Committee

11. 16 May 1983

    Reported

    Reported to House (Amended) by House Committee on Energy and Commerce. Report No: 98-191.

    Source: Committee

12. 24 May 1983

    Floor

    Committee on Rules Granted an Open Rule Providing One Hour of Debate; Waiving Section 303(a)(4) of the Budget Act.

    Source: Floor

13. 24 May 1983

    Reported

    Rules Committee Resolution H.Res.208 Reported to House.

    Source: Floor

14. 14 July 1983

    Passed

    Rule Passed House.

    Source: Floor

15. 25 July 1983

    Floor

    Called up by House by Rule.

    Source: Floor

16. 17 November 1983

    Passed

    Passed/agreed to in House: Passed House (Amended) by Voice Vote.

    Source: Floor

17. 17 November 1983

    Passed

    Passed House (Amended) by Voice Vote.

    Source: Floor

18. 17 November 1983

    Passed

    House Agreed to Amendments Adopted by the Committee of the Whole.

    Source: Floor

19. 18 November 1983

    Introduced

    Received in the Senate and read twice and referred to the Committee on Labor and Human Resources.

    Source: IntroReferral

20. 5 June 1984

    Committee

    See S.540.

    Source: Committee

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

3 official files

• Passed House amended

  summary · EN · 17 November 1983

  Open at official source

• Reported to House with amendment(s)

  summary · EN · 16 May 1983

  Open at official source

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• Introduced in House

  summary · EN · 24 March 1983

  Open at official source

  Leesvertaling

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Sponsors

• Rep. Waxman, Henry A. [D-CA-33] · D · Sponsor
• Rep. Scheuer, James H. [D-NY-8] · D · Sponsor
• Rep. Luken, Thomas A. [D-OH-1] · D · Sponsor
• Rep. Walgren, Doug [D-PA-18] · D · Sponsor
• Sen. Mikulski, Barbara A. [D-MD] · D · Sponsor
• Sen. Shelby, Richard C. [R-AL] · D · Sponsor
• Sen. Wyden, Ron [D-OR] · D · Sponsor
• Rep. Sikorski, Gerry E. [D-MN-6] · D · Sponsor
• Rep. Ottinger, Richard L. [D-NY-20] · D · Sponsor
• Sen. Wirth, Timothy [D-CO] · D · Sponsor
• Rep. Pepper, Claude [D-FL-18] · D · Cosponsor
• Rep. Berman, Howard L. [D-CA-28] · D · Cosponsor
• · sshr00 · Standing
• · hsif00 · Standing

Related records

• related to → Health Research Extension Act of 1983
• related to → A resolution providing for the consideration of the bill (H.R. 2350) to amend the Public Health Service Act to revise and extend the authorities under that Act relating to the National Institutes of Health and the National Research Institutes, and for other purposes.
• related to ← National Institute of Arthritis and Musculoskeletal and Skin Diseases Act of 1984
• amends ← A substitute amendment to reauthorize the National Cancer Institute the National Heart, Lung, and Blood Institute of NIH for three years at the levels contained in the committee bill, including establishment of a new National Institute on Musculoskeletal Diseases and Arthritis and health promotion and disease prevention centers. It leaves NIH's general research authority intact, removes most of the line item authorizations, does not transfer any outside agencies to NIH and strikes NIH management changes. It contains the animal welfare guidelines, establishes the National Commission on Orphan Diseases, and mandates certain studies, including the animal welfare study.
• amends ← An amendment to establish in the Institute a Lupus Erythematosus Coordinating Committee to plan, develop, coordinate, and implement comprehensive Federal initiatives in research on Lupus Erythematosus. The committee is required to meet quarterly and must submit to Congress an annual report.
• amends ← An amendment to the Shelby substitute amendment to establish a National Institute of Nursing within NIH to take over the duties of the Division of Nursing of the Health Resources and Services Administration.
• amends ← An amendment to the Shelby substitute amendment that "the Director of NIH and the director of any national research institute may not conduct or support research or experimentation, in the United States or abroad, on a living human fetus or infant, before an abortion which the researcher involved knows or has reason to know is intended or after an abortion, unless the research or experimentation is for the purpose of improving the probability of the survival of, or ameliorating developmental or congenital defects in, such infant.".
• amends ← An amendment to the Shelby substitute amendment to transfer the National Institute for Occupational Safety to NIH.
• amends ← An amendment to the Shelby substitute amendment to prohibit waiver of requirements on fetal research unless application is made to the Secretary with the approval of the Institutional Review Board with jurisdiction over the applicant. The Secretary may not approve a waiver or modification of regulations without convening an ethics advisory board and determining that the risks to the fetus involved are so outweighed by the sum of the benefit to the fetus and the importance of the knowledge to be gained is so great as to granting the application. It must also be shown that without the waiver such benefits cannot be obtained. Waivers and modifications are to be published in the Federal Register.