National Institute of Arthritis and Musculoskeletal and Skin Diseases Act of 1984

(Conference report filed in House, H. Rept. 98-1155)

Health Research Extension Act of 1984 - 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 and Skin Diseases.

Establishes as agencies within NIH: (1) the Division of Research Resources; (2) the National Library of Medicine; and (3) the John E. Fogarty International Center for Advanced Study in the Health Sciences.

Permits the Secretary of Health and Human Services to establish additional research institutes.

Provides that: (1) NIH shall be headed by a Director, who shall be appointed by the President by and with the advice and consent of the Senate; and (2) the Secretary acting through the Director shall be responsible for the overall direction of NIH, including specified administrative and supervisory functions.

Exempts scientific peer review panels from Federal Advisory Committee Act jurisdiction.

Establishes the position of Associate Director for Prevention in NIH. Transfers disease prevention research coordination and promotion functions to the Associate Director. Requires the Associate Director to report annually to the Director of NIH.

Consolidates existing NIH reporting requirements into a single biennial report, with the first such report due by December 30, 1985.

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.

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. Increases the representation of experts on such advisory councils. Requires the director of each institute to prepare a biennial report.

Authorizes specified appropriations for FY 1985 and 1986. Limits administrative expenses to five and one-half percent of annual appropriations. Excludes from such limit the National Library of Medicine, the John E. Fogarty International Center for Advanced Study in the Health Sciences, and the Office of Medical Applications of Research.

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) 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) maintain the International Cancer Research Data Bank, and disseminate information to the public, general practitioners, and oncologic investigators; (6) hire experts and consultants; (7) acquire, repair, or construct facilities, including facilities in the District of Columbia; (8) appoint advisory committees; (9) enter into contracts, leases, or other transactions; and (10) 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).

Establishes the position of Associate Director for Prevention to coordinate and promote Institute cancer prevention programs.

Requires vacancies on the President's Cancer Panel to be filled within 90 days.

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.

Replaces the existing position of Associate Director for Prevention, Education, and Control with the position of Associate Director for Prevention. Charges such Director with responsibility to coordinate and promote Institute programs on 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, Division 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 and Skin Diseases.

Establishes an information clearinghouse and data system, arthritis and skin diseases coordinating committees, demonstration project grant authority, and multipurpose centers. 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. Authorizes the establishment of research and clinical centers for Alzheimer's disease. Directs the Secretary to make grants for Alzheimer's disease research.

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.

Directs the Institute of Neurological and Communicative Disorders and Stroke to provide grants for bioengineering research on overcoming paralysis of the extremities through electrical stimulation and the use of computers. Requires the Director of such Institute to conduct and support spinal cord regeneration research.

Establishes within NIH the National Institute of Nursing to conduct and support the dissemination of information respecting research, training, and related nursing programs.

Authorizes the Director of such Institute to: (1) provide training and instruction and establish traineeships and fellowships, including stipends; and (2) make grants to nonprofit institutions to provide such training and fellowships.

Names the Chief Nursing Officer of the Veterans Administration and the Director of the Division of Nursing of the Health Resources and Services Administration as ex-officio members of such Institute's advisory council.

Establishes the position of Associate Director for Prevention to coordinate and promote mothers and children's health programs in the National Institute of Child Health and Human Development.

Transfers the National Library of Medicine from the Public Health Service to NIH. Revises specified provisions relating to the Library's Board of Regents. Authorizes FY 1985 and 1986 appropriations for: (1) training; (2) special projects and research; (3) resource improvement and expansion; (4) regional medical libraries; and (5) biomedical scientific publications.

Sets forth the general purposes of the Division of Research Resources, and the John E. Fogarty International Center for Advanced Study in the Health Sciences.

Authorizes FY 1985 and 1986 appropriations for National Research Service Awards.

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 guidelines, including the formation of animal care committees. Requires NIH grant and contract recipients to meet such guidelines. Prohibits any such guideline from requiring a research entity to disclose privileged commercial information or trade secrets.

Permits the Secretary to support research involving a nonviable living human fetus ex utero, or a living human fetus ex utero for whom viability has not been ascertained, only if such research: (1) may enhance the well-being or meet the health needs of the fetus; or (2) will pose no additional risk to the fetus and whose purpose is to develop otherwise unobtainable important biomedical knowledge. Applies such standard to fetuses which are intended to be aborted and to fetuses which are intended to be carried to term.

Requires the Biomedical Ethics Advisory Committee to: (1) conduct a study of the nature, advisability, and biomedical and ethical implications of exercising any waiver of the existing Federal Standard for fetal research; and (2) report to the Biomedical Ethics Board within 30 days. Requires the Board to transmit such report to the Secretary and the appropriate congressional committees.

Places a 36-month prohibition on specified greater-than-minimal risk research on human fetuses. Repeals such prohibition effective October 31, 1987.

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.

Requires the Secretary, through the Director of NIH, to request the National Academy of Sciences to study the use of live animals in biomedical and behavioral research. Sets forth report provisions, including an assessment of the impact of Federal standards, a review of relevant Federal and State laws, and a determination of the number and types of test animals. Requires a report to the appropriate congressional committees within 18 months. Directs the Secretary to engage a nonprofit private entity to conduct such study if the National Academy of Sciences chooses not to.

Requires the Director of NIH to: (1) develop a plan by October 1, 1985, for conducting research into methods for reducing or eliminating the use of animals in biomedical and behavioral research and experimentation; and (2) establish an Interagency Coordinating Committee to assist in such plan development.

Directs the Secretary to establish an NIH Lupus Erythematosus Coordinating Committee. Requires a Committee report within 18 months. Terminates the Committee one month after it submits such report.

Directs the Secretary to: (1) conduct a study of the National Research Service Awards; and (2) report to the appropriate congressional committees within one year.

Directs the Secretary to: (1) establish within 90 days an Interagency Committee on Spinal Cord Injury in the National Institute of Neurological and Communicative Diseases and Stroke; and (2) report to Congress within 18 months. Terminates the Committee 90 days after it submits such report.

Directs the Secretary to: (1) conduct a study of personnel for the health needs of the elderly; and (2) report to the appropriate congressional committees by March 1, 1986.

Requires the Director of NIH to establish within 90 days an Interagency Committee on Learning Disabilities. Requires the Committee to report to Congress within 18 months. Terminates the Committee 90 days after it submits such report.

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, 1986. Terminates such Commission 90 days after it submits such report. Obligates specified FY 1985 NIH appropriations for such purpose.

Requires the Secretary to conduct a one-year study of the research programs of the National Institute of Diabetes and Digestive and Kidney Diseases to determine if such programs could be more effectively carried out by another institute.

Establishes in the legislative branch of the Government a Biomedical Ethics Board made up of six Senators and six Representatives. Directs such Board to study and report to Congress on a continuing basis on the ethical issues arising from the delivery of health care and biomedical and behavioral research, including the protection of human research subjects and developments in genetic engineering.

Requires additional reports on: (1) genetic engineering developments having implications for human genetic engineering; and (2) areas of medicine and research having significant ethical implications.

Requires the Board to appoint a Biomedical Ethics Advisory Committee to conduct such studies and reports. Authorizes FY 1985 through 1987 appropriations.

Directs the Secretary, in consultation with the Director of NIH and the Commissioner of the Food and Drug Administration, to make a grant to an academic institution for the operation of a center to conduct research on the health effects of nuclear energy and other new energy technologies. Funds the center from specified FY 1985 and 1986 amounts under such Act.

Directs the National Cancer Institute to establish in FY 1985 a cancer screening and research facility near the Nevada nuclear test sites.