H.R.5495 - National Institutes of Health Revitalization Amendments of 1992102nd Congress (1991-1992)
|Sponsor:||Rep. Waxman, Henry A. [D-CA-24] (Introduced 06/25/1992)|
|Committees:||House - Energy and Commerce|
|Latest Action:||07/14/1992 Referred to the Subcommittee on Health and the Environment.|
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Summary: H.R.5495 — 102nd Congress (1991-1992)All Bill Information (Except Text)
Introduced in House (06/25/1992)
National Institutes of Health Revitalization Amendments of 1992 - 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 - Amends the Public Health Service Act to prohibit the Secretary of Health and Human Services from approving certain research or financial assistance to conduct research unless specified review has taken place and the review entity has recommended approval.
Prohibits the Secretary from withholding, on ethical grounds, funding for research that has received such review approval unless: (1) an ethics advisory board recommends the withholding; or (2) such a board recommends against withholding, but the Secretary finds that the recommendation is arbitrary and capricious.
Part II: Research on Transplantation of Fetal Tissue - Permits the Secretary to conduct or support research on the transplantation of human fetal tissue for therapeutic purposes regardless of whether the tissue is obtained from a spontaneous or induced abortion or a stillbirth, in accordance with State and local law. Requires the researcher, if the tissue bank established under a specified executive order is in operation, to obtain the tissue from that bank, unless the bank does not provide requested tissue within a specified time of a request. Requires certain statements by the woman providing the tissue, the researcher, and the donee.
Imposes criminal penalties for certain commercial transactions involving the transfer or directed donation of human fetal tissue.
Prohibits: (1) any official of the executive branch from imposing a policy prohibiting the Department of Health and Human Services from conducting or supporting any research on the transplantation of human fetal tissue for therapeutic purposes; and (2) the Secretary from withholding funds for research which is in accordance with this Act.
Deems a specified report of the Human Fetal Tissue Transplantation Research Panel to be a report issued by an ethics advisory board finding, on a basis that is neither arbitrary nor capricious, that there are no ethical grounds for withholding funds for such research.
Part III: Miscellaneous Repeals - Removes certain provisions of the Public Health Service Act relating to: (1) biomedical ethics; (2) a study by the Biomedical Ethics Advisory Committee on waiver of a specified risk standard; and (3) the construction of title IV (National Research Institutes) of the Act.
Subtitle B: Clinical Research Equity Regarding Women and Minorities - Part I: Women and Minorities as Subjects in Clinical Research - Requires that women and minorities be included as subjects in each clinical research project under such title IV. Requires projects to be designed and carried out so as to provide for an analysis of whether the variables being tested affect women or minorities differently than other subjects. Requires the establishment of inclusion guidelines.
Requires that technical and scientific peer review conducted under existing provisions include an evaluation of the merit of the proposal regarding women and minorities.
Part II: Office of Research on Women's Health - Establishes in the National Institutes of Health (NIH) the Office of Research on Women's Health. Requires the Director of the Office to establish: (1) the Coordinating Committee on Research on Women's Health; and (2) the Advisory Committee on Research on Women's Health.
Mandates: (1) a determination of the extent to which women are represented among senior physicians and scientists of the national research institutes and among those conducting research supported by the institutes; and (2) as appropriate, activities to increase the extent of such representation.
Requires establishment of: (1) a data system, available to the public, for the collection, analysis, and dissemination of information regarding research on women's health conducted or supported by the institutes; and (2) a program to provide information on research and prevention activities of the institutes relating to women's health research.
Subtitle C: Scientific Integrity - Replaces provisions relating to protection against scientific fraud with provisions establishing as an independent entity in the Department of Health and Human Services the Office of Scientific Integrity.
Requires: (1) applicants for a grant, contract, or cooperative agreement under the Act for biomedical or behavioral research to have an administrative process to review reports of scientific misconduct and agree to report any investigation of such reports; and (2) a response process for the Office.
Establishes the Commission on Scientific Integrity.
Provides for employee whistle blower protection.
Mandates measures for identifying, responding to, and reporting the existence of a financial interest that will or may create a bias in favor of obtaining results, in a project to evaluate the safety or effectiveness of a drug, medical device, or treatment, that are consistent with the interest.
Title II: Protection of Health Facilities - Prohibits stealing or otherwise converting personal property or damaging real property of a health facility assisted under the Public Health Service Act, or deterring, through physical restraint, any individual from entering or exiting the facility. Includes in the prohibitions various acts interfering with the use of animals for research. Provides for fines, imprisonment, restitution, and private civil actions.
Title III: National Institutes of Health in General - Modifies the duties of the NIH's Associate Director for Prevention.
Establishes a program to enhance the competitiveness of research entities in States which have historically had low success in obtaining funds from the national research institutes for biomedical and behavioral research.
Mandates activities, consistent with the global Children's Vaccine Initiative, to develop affordable new and improved vaccines. Authorizes appropriations.
Requires a plan regarding research methods that do not require the use of animals, reduce the number of animals used, and produce less distress in the animals. Establishes the Interagency Coordinating Committee on the Use of Animals in Research. Repeals similar provisions.
Authorizes the Secretary of Health and Human Services to conduct and support research, research training, recruitment, and other activities to increase the number of women and individuals from disadvantaged backgrounds in biomedical and behavioral research.
Requires that any survey of human sexual behavior conducted or supported through NIH: (1) undergo review in accordance with specified provisions; and (2) have been determined by the Secretary to assist in reducing the incidence of infectious disease or improve health conditions.
Establishes a fund for use by the NIH Director to carry out NIH activities. Authorizes appropriations.
Modifies the term of office of members of advisory councils of the national research institutes.
Requires that at least half of all new or revised health education and promotion materials developed or funded by NIH be in a form that does not exceed a level of functional literacy.
Authorizes a program to provide day care service for NIH employees.
Title IV: General Provisions Respecting National Research Institutes - Requires that the Secretary 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. Removes provisions authorizing the Director of the National Cancer Institute to directly receive such funds.
Modifies the authority of the directors of the national research institutes to establish and appoint the members of technical and scientific peer review groups in addition to those appointed under specified provisions. Makes the Federal Advisory Committee Act inapplicable to such additional groups.
Requires expansion and intensification of programs of research and related activities concerning osteoporosis, Paget's disease, and related bone disorders. Provides for the establishment, through a grant, cooperative agreement, or contract, of a clearinghouse to enhance knowledge and understanding of professionals, patients, and the public. Authorizes appropriations.
Establishes: (1) a comprehensive program of conducting basic and clinical research on trauma, including diagnosis, treatment, rehabilitation, and general management of trauma; and (2) the Trauma Research Interagency Coordinating Committee.
Title V: National Cancer Institute - Requires expanding, intensifying, and coordinating the activities of the National Cancer Institute (NCI) regarding breast and ovarian cancer, other cancers of the reproductive system of women, and prostate cancer. Requires inclusion of the conduct and support of research and demonstration centers. Authorizes appropriations. Removes provisions authorizing appropriations for NCI and the National Heart, Lung, and Blood Institute (NHLBI).
Title VI: National Heart, Lung, and Blood Institute - Requires NHLBI to conduct intramural training and education.
Authorizes development of three centers for basic and clinical research into, training in, and demonstration of, advanced diagnosis, prevention, and treatment for cardiovascular diseases in children.
Authorizes appropriations for NHLBI.
Title VII: National Institute on Diabetes and Digestive and Kidney Diseases - Establishes a program of conducting and supporting research, training, health information dissemination, and other activities regarding nutritional disorders, including obesity. Provides for the development or substantial expansion of centers for research and training.
Title VIII: National Institute on Arthritis and Musculoskeletal and Skin Diseases - Removes provisions stating that the purpose of the National Institute on Arthritis and Musculoskeletal and Skin Diseases (NIAMSD) includes sports-related injuries.
Requires NIAMSD to place emphasis on arthritis affecting children. Establishes a multipurpose arthritis and musculoskeletal disease center focusing on children.
Modifies the composition of the National Arthritis Advisory Board and its annual report requirements.
Title IX: National Institute on Aging - Transfers to the Public Health Service Act provisions of the Health Research Extension Act of 1985 authorizing a grant to develop a registry for epidemiological data on Alzheimer's disease and related data collection training. Removes the existing authorization of appropriations.
Mandates research into the aging processes of women, with particular emphasis on menopause and into the diagnosis, disorders, and complications related to aging and loss of ovarian hormones.
Authorizes appropriations for the National Institute on Aging.
Title X: National Institute of Allergy and Infectious Diseases - Includes programs regarding tropical diseases in the purposes of the National Institute of Allergy and Infectious Diseases.
Authorizes grants or contracts for centers to conduct basic and clinical research on chronic fatigue syndrome. Establishes an extramural study section for the syndrome.
Title XI: National Institute of Child Health and Human Development - Subtitle A: Research Centers with Respect to Contraception and Research Centers with Respect to Infertility - Mandates grants or contracts for three centers to conduct activities to improve methods of contraception and two centers to conduct activities to improve methods of diagnosis and treatment of infertility. Authorizes appropriations.
Establishes a program of agreements with health professionals, including graduate students, to conduct research on contraception or infertility in consideration of the Government repaying a limited amount of the educational loans of the professionals.
Subtitle B: Program Regarding Obstetrics and Gynecology - Establishes in the National Institute of Child Health and Human Development (NICHHD) an intramural laboratory and clinical research program in obstetrics and gynecology.
Subtitle C: Child Health Research Centers - Mandates development of and support for centers for conducting research on child health.
Subtitle D: Study Regarding Adolescent Health - Mandates a longitudinal, large-scale study on the general health and well-being of adolescents in the United States. Allocates funding from amounts appropriated to NICHHD.
Title XII: National Eye Institute - Authorizes not more than three grants for the establishment and support of centers for clinical research on eye care for individuals with diabetes. Allows grant funds to be used for equipment and for construction and modification of facilities.
Title XIII: National Institute of Neurological Disorders and Stroke - Mandates the conduct and support of research on multiple sclerosis.
Title XIV: National Institute of Environmental Health Sciences - Establishes the Applied Toxicological Research and Testing Program.
Title XV: National Library of Medicine - Subtitle A: General Provisions - Directs the Secretary to promote the use of computers and telecommunications by health professionals.
Increases the dollar limit on grants to medical libraries and related instrumentalities.
Authorizes appropriations for the National Library of Medicine (NLM).
Subtitle B: Financial Assistance - Mandates grants for research on, and development and demonstration of, new educational technologies. Requires recipient institutions to make grant projects available for: (1) training health professions students; and (2) enhancing the capabilities of health professionals regarding research and teaching.
Authorizes appropriations to carry out provisions relating to medical libraries and related matters.
Subtitle C: National Center for Biotechnology Information - Authorizes appropriations to carry out provisions relating to the National Center for Biotechnology Information.
Subtitle D: National Information Center on Health Services Research and Health Care Technology - Establishes in NLM the National Information Center on Health Services Research and Health Care Technology to collect, analyze, and disseminate information on health services research and health care technology. Authorizes appropriations. Requires the Administrator of the existing information center on health care technologies and health care technology assessment and the NLM Director to enter into an agreement on the implementation of these provisions.
Title XVI: Other Agencies of National Institutes of Health - Subtitle A: Division of Research Resources - Redesignates the Division of Research Resources as the National Center for Research Resources.
Authorizes grants to alter existing or construct new research facilities. Establishes the Scientific and Technical Review Board on Biomedical and Behavioral Research Facilities to advise the Center director and the existing advisory council. Conditions grant approval on Board approval. Authorizes appropriations. Requires the NIH Director to reserve a specified sum from amounts appropriated under this authorization for grants and contracts to construct or improve regional centers for research on primates.
Subtitle B: National Center for Nursing Research - Redesignates the National Center for Nursing Research as the National Institute for Nursing Research and adds the Institute to the list of NIH's national research institutes.
Subtitle C: National Center for Human Genome Research - Adds the National Center for Human Genome Research to the list of NIH agencies. Declares the purpose of the Center to be to characterize the structure and function of the human genome, including the mapping and sequencing of individual genes.
Title XVII: Awards and Training - Subtitle A: National Research Service Awards - Directs the Secretary to carry out provisions relating to National Research Service Awards in a manner that will recruit into biomedical or behavioral research, and provide research training to, women and individuals from disadvantaged backgrounds.
Subtitle B: Acquired Immune Deficiency Syndrome - Modifies a program of agreements (under which certain health professionals conduct research regarding acquired immune deficiency syndrome (AIDS) as NIH employees in consideration of Government repayment of educational loans) to remove provisions requiring a minimum of three years as an NIH employee. Authorizes appropriations. Authorizes the Commissioner of Food and Drugs to carry out a similar program regarding the review of applications concerning AIDS.
Subtitle C: Loan Repayment for Research Generally - Mandates a program of agreements with health professionals who have a substantial amount of educational loans relative to income and who meet other requirements to conduct research, as NIH employees, in consideration of Government repayment of a limited amount of the educational loans of the professionals. Authorizes appropriations.
Subtitle D: Scholarship and Loan Repayment Programs Regarding Professional Skills Needed by Certain Agencies - Authorizes a program of contracts with individuals from disadvantaged backgrounds for scholarships for undergraduate programs for professions needed by NIH in consideration of service by the individuals as NIH employees.
Authorizes a program of contracts with health professionals from disadvantaged backgrounds who have a substantial amount of educational loans relative to income to conduct clinical research as NIH employees in consideration of the Government repaying a limited amount of the educational loans of the professionals.
Subtitle D: (SIC) Funding - Authorizes appropriations for making payments under National Research Service Awards and under grants for such Awards. Modifies set-aside amounts and requires a set-aside for provisions relating to residency programs in the general practice of dentistry.
Title XVIII: National Foundation for Biomedical Research - Excludes from voting rights the ex officio members of the National Foundation for Biomedical Research. Authorizes appropriations.
Title XIX: Research with Respect to Acquired Immune Deficiency Syndrome - Modifies the duties of the AIDS Clinical Research Review Committee, including requiring the Committee to: (1) give advice to other agencies of NIH as well as to the National Institute of Allergy and Infectious Diseases (NIAID); and (2) make recommendations on research projects regarding diagnosing immune deficiency and predicting, diagnosing, preventing, and treating opportunistic cancers and infectious diseases.
States that the requirement that the clinical evaluation units at the National Cancer Institute and NIAID conduct evaluations of treatments for acquired immune deficiency syndrome (AIDS) includes evaluations of methods of: (1) diagnosing immune deficiency; and (2) predicting, diagnosing, preventing, and treating opportunistic cancers and infectious diseases.
Modifies provisions relating to the support of international efforts to add to the purpose of grants, cooperative agreements, and contracts for such efforts provisions promoting and expediting: (1) international training; (2) research and training concerning the natural history and pathogenesis of the human immunodeficiency virus; and (3) the development and evaluation of vaccines and treatments for opportunistic infections. Authorizes appropriations for each fiscal year.
Requires that model protocols (developed with grants under existing provisions) for the clinical care of individuals infected with the etiologic agent for AIDS include treatment and prevention of human immunodeficiency virus (HIV) infection and related conditions among women. Authorizes appropriations.
Adds collection of data on the natural history of infection with the etiologic agent to the purposes of the epidemiological data base mandated by current provisions. Authorizes appropriations for each fiscal year.
Requires the Director of NIH to develop and implement a comprehensive plan for the conduct and support of AIDS research by NIH agencies.
Authorizes appropriations for each fiscal year for fellowship and training programs relating to AIDS under existing provisions.
Title XX: Certain Authorities of Centers for Disease Control - Authorizes grants to States and local health departments for programs for specified activities relating to prostate cancer, including screening, public information, and improving professional training. Authorizes appropriations.
Authorizes: (1) grants or contracts for population-based, statewide cancer registries; (2) grants for developing plans that meet the requirements of specified provisions; and (3) technical assistance to States, either directly or through grants and contracts. Mandates a study on the factors contributing to elevated breast cancer mortality rates in specified States. Authorizes appropriations.
Requires a survey to determine which entities collect data on traumatic brain injuries and the nature of their data collection systems. Authorizes cooperation and assistance to establish traumatic brain injury as a specific reportable condition or disability. Authorizes appropriations.
Title XXI: Studies - Mandates studies on: (1) the impact, with regard to acquired immune deficiency syndrome (AIDS), of parallel-track drug-release mechanisms on clinical research and on the activities of the Commissioner of Food and Drugs regarding drug approval; (2) third-party payor policies regarding payment of costs incident to the participation of individuals as subjects in AIDS drug clinical trials; and (3) whether AIDS advisory committees in NIH are being sufficiently coordinated.
Requires a plan for the inclusion of HIV-infected women, infants, and children in HIV vaccine studies conducted by or through NIH. Authorizes appropriations.
Mandates an annual report on the leading causes of death in the United States and related spending by the Department of Health and Human Services for research, prevention, and education.
Requires three-year studies on: (1) nutrition screening and intervention regarding the elderly; and (2) the extent of malnutrition in hospitals, in long-term care facilities, and among those living independently. Establishes an advisory panel to oversee the studies.
Mandates a report on the feasibility of developing a plan for the conduct of research at NIH on the prevention of traumatic injuries.
Directs the Secretary to: (1) review existing data and research concerning whether there is a relationship between legal and illegal drug use; and (2) if necessary, conduct additional research.
Mandates reports on: (1) research conducted or supported by NIH on chronic fatigue syndrome; (2) the appropriateness and impact of NIH assuming responsibility for the conduct of all Federal research, development, testing, and evaluation relating to medical countermeasures against biowarfare threat agents.
Requires a study on the potential for, the prevalence of, and the issues related to the contamination of worker's homes with substances from their work places. Requires: (1) establishment of the Worker's Family Protection Task Force to take specified actions, including developing an investigative strategy for obtaining any needed additional data; and (2) each Federal department or agency to fulfill the role assigned by the strategy. Authorizes appropriations.
Mandates studies: (1) of the retention, recruitment, vacancy and turnover rates of NIH support staff, including fire fighters, law enforcement, procurement officers, technicians, nurses, and clerical employees; and (2) to develop a streamlined procurement system for NIH.
Title XXII: Miscellaneous Provisions - Redesignates the Senior Biomedical Research Service as the Silvio Conte Senior Biomedical Research Service and increases the limit on the number of its members.
Renames the AIDS Clinical Research Review Committee as the AIDS Research Advisory Committee.
Prohibits the Secretary from conducting or supporting the SHARP survey of adult sexual behavior.
Requires that a report on carcinogens be submitted biennially (currently, annually).
Mandates a report analyzing the report of the National Committee on Sleep Disorders Research and presenting a plan for the conduct and support of sleep disorders research at NIH.
Mandates presentation to the Congress of a master plan to provide for the replacement or refurbishment of less than adequate buildings, utility equipment and distribution systems, roads, walkways, parking areas, and grounds of NIH laboratory and clinical facilities. Allows the plan to make recommendations for the undertaking of new projects consistent with the objectives of these provisions.
Title XXIII: Effective Date - Sets forth the effective date of this Act.