The NIH Almanac
This legislative chronology is limited to enactments that had a major influence upon the Marine Hospital Service as it evolved into the PHS, to legislation leading to the establishment of the National Institutes of Health, and to specific NIH legislation with the exception of appropriations bills, unless such bills provided significant new authorities for or restrictions on NIH components. To view the actual public law, see the Office of NIH History website http://history.nih.gov/research/sources_legislative_chronology.html.
July 16, 1798—"An Act for the relief of sick and disabled Seamen" established the Marine Hospital Service for merchant seamen. The Marine Hospital Service—forerunner of the present-day PHS—became a component of the Treasury Department. A monthly hospital tax of 20 cents was deducted from the pay of merchant seamen in the first prepaid medical care plan in the United States. (1 Stat. L. 605.)
March 2, 1799—An amending act to the legislation of 1798 extended Marine Hospital Service benefits to officers and men of the U.S. Navy. This arrangement continued until 1818 after which the Navy built its own hospitals. However, the deduction of 20 cents per month from the pay of Navy and Marine Corps personnel continued until June 15, 1943. (1 Stat. L. 729.)
June 29, 1870—A bill to reorganize the Marine Hospital Service and establish a central controlling office in Washington, D.C., was enacted. This act also increased the amount of hospital tax paid by seamen from 20 cents to 40 cents per month, a tax which continued until 1884. (16 Stat. L. 169.) (After the seamen's hospital tax was abolished July 1, 1884, the cost of maintaining Marine hospitals was paid out of a tonnage tax until 1906. Since then medical care for merchant seamen and other beneficiaries of the service has been supported by direct congressional appropriations.)
March 3, 1875—An act was passed authorizing the admission of seamen from the Navy and other government services to Marine hospitals on a reimbursable basis.
The Surgeon General of the Marine Hospital Service was to be appointed by the President, by and with the advice and consent of the Senate. (18 Stat. L. 377.)
April 29, 1878—The first Federal Quarantine Act "to prevent the introduction of contagious or infectious diseases into the United States" was passed. (20 Stat. L. 37.)
March 3, 1879—The National Board of Health was created by law and given quarantine powers; first organized, comprehensive Federal medical research effort. (20 Stat. L. 484.)
January 4, 1889—A bill to establish a commissioned officer corps in the Marine Hospital Service was passed. This law established a mobile corps subject to duty anywhere upon assignment, a policy that had been in effect since Dr. Woodworth assumed leadership of the Marine Hospital Service in 1871. (25 Stat. L. 639.)
March 27, 1890—Congress gave the Marine Hospital Service interstate quarantine authority. (26 Stat. L. 31.)
February 15, 1893—A new Quarantine Act was passed following outbreaks of cholera in Europe, strengthening the inadequate Quarantine Act of 1878 by giving the Federal Government the right of quarantine inspection. The act of March 3, 1879, was repealed. (27 Stat. L. 449.)
March 2, 1899—The Marine Hospital Service was directed by Congress to investigate leprosy in the United States. (30 Stat. L. 976.)
March 3, 1901—An appropriation of $35,000 was made for the Hygienic Laboratory building (first legislative mention of Hygienic Laboratory). Thus "investigations of contagious and infectious diseases and matters pertaining to public health" were given definite status in law. (31 Stat. L. 1086.)
July 1, 1902—A bill to increase the efficiency and change the name of the Marine Hospital Service to Public Health and Marine Hospital Service was enacted. The law authorized the establishment of specified administrative divisions and, for the first time, designated a bureau of the Federal Government as an agency in which public health matters could be coordinated. (32 Stat. L. 712.)
Another law, usually referred to as the Biologics Control Act, authorized the Public Health and Marine Hospital Service to regulate the transportation or sale for human use of viruses, serums, vaccines, antitoxins, and analogous products in interstate traffic or from any foreign country into the United States. (P.L. 57-244, 32 Stat. L. 728.)
August 14, 1912—Under an act, the name Public Health and Marine Hospital Service was changed to Public Health Service. The legislation broadened the PHS research program to include "diseases of man" and contributing factors such as pollution of navigable streams, and information dissemination. (37 Stat. L. 309.)
July 9, 1918—The Chamberlain-Kahn Act provided for the study of venereal diseases by the PHS. (40 Stat. L. 886.)
October 27, 1918—A PHS reserve corps was established. The 1918 influenza pandemic emphasized the need for a reserve corps to meet such emergency situations. (40 Stat. L. 1017.)
January 19, 1929—The Narcotics Control Act provided for construction of two hospitals for the care and treatment of drug addicts, and authorized creation of a Narcotics Division in the PHS Office of the Surgeon General. (P.L. 70-672, 45 Stat. L. 1085.)
April 9, 1930—A law changed the name of the Advisory Board for the Hygienic Laboratory to the National Advisory Health Council. (P.L. 71-106, 46 Stat. L. 152.)
May 26, 1930—The Ransdell Act reorganized, expanded, and redesignated the Hygienic Laboratory as the National Institute of Health. The act authorized $750,000 for the construction of two buildings for NIH and authorized a system of fellowships. (P.L. 71-251, 46 Stat. L. 379.)
June 14, 1930—A law authorized creation of a separate Bureau of Narcotics in the Treasury Department to control trading in narcotic drugs and their use for therapeutic purposes. Also, the legislation redesignated the PHS Narcotics Division to the Division of Mental Hygiene, giving the Surgeon General authority to investigate abuse of narcotics and the causes, treatment, and prevention of mental and nervous diseases. (P.L. 71-357, 46 Stat. L. 585.)
August 14, 1935—The Social Security Act was an event of major importance in the progress of public health in the United States. This act authorized health grants to the states on the principle that the most effective way to prevent the interstate spread of disease is to improve state and local public health programs. With this legislation, the PHS became adviser and practical assistant to state and local health services. (P.L. 74-271, 49 Stat. L. 634.)
August 5, 1937—A law established the National Cancer Institute to conduct and support research relating to the cause, diagnosis, and treatment of cancer. The law authorized the Surgeon General to make grants-in-aid for research in the field of cancer, provide fellowships, train personnel, and assist the states in their efforts toward cancer prevention and control. (P.L. 75-244, 50 Stat. L. 559.)
April 3, 1939—The Reorganization Act of 1939 transferred the PHS from the Treasury Department to the Federal Security Agency. (P.L. 76-19, 53 Stat. L. 561.)
July 1, 1944—The PHS act consolidated and revised laws pertaining to the PHS and divided the service into the Office of the Surgeon General, Bureau of Medical Services, Bureau of State Services, and the National Institute of Health. The act gave the Surgeon General broad powers to conduct and support research into the diseases and disabilities of man, authorized projects and fellowships, and made the National Cancer Institute a division of NIH. The act also empowered the Surgeon General to treat at PHS medical facilities, for purposes of study, persons not otherwise eligible for such treatment. (P.L. 78-410, 58 Stat. L. 682.) Under this provision, the Clinical Center was later established. (Under this act, the Research Grants Office, January 1, 1946; the Experimental Biology and Medicine Institute and the National Microbiological Institute, November 1, 1948; and the Division of Research Services, January 1, 1956, were established.)
July 3, 1946—The National Mental Health Act was designed to improve the mental health of U.S. citizens through research into the causes, diagnosis, and treatment of psychiatric disorders. It authorized the Surgeon General to support research, training, and assistance to state mental health programs. (P.L. 79-487, 60 Stat. L. 421.) (The National Institute of Mental Health was established under the authority of this law on April 15, 1949.)
August 13, 1946—The Hospital Survey and Construction Act (Hill-Burton Act) authorized grants to the states for construction of hospitals and public health centers, for planning construction of additional facilities, and for surveying existing hospitals and other facilities. (P.L. 79-725, 60 Stat. L. 1040.)
July 8, 1947—Under P.L. 80-165, research construction provisions of the Appropriations Act for FY 1948 provided funds "for the acquisition of a site, and the preparation of plans, specifications, and drawings, for additional research buildings and a 600-bed clinical research hospital and necessary accessory buildings related thereto to be used in general medical research...."
June 16, 1948—The National Heart Act authorized the National Heart Institute to conduct, assist, and foster research; provide training; and assist the states in the prevention, diagnosis, and treatment of heart diseases. In addition, the act changed the name of National Institute of Health to National Institutes of Health. (P.L. 80-655, 62 Stat. L. 464.)
June 24, 1948—The National Dental Research Act authorized the National Institute of Dental Research to conduct, assist, and foster dental research; provide training; and cooperate with the states in the prevention and control of dental diseases. (P.L. 80-755, 62 Stat. L. 598.)
August 15, 1950—The Omnibus Medical Research Act authorized the Surgeon General to establish the National Institute of Neurological Diseases and Blindness, as well as additional institutes, to conduct and support research and research training relating to other diseases and groups of diseases. (P.L. 81-692, 64 Stat. L. 443.) (The National Institute of Arthritis and Metabolic Diseases and the National Institute of Neurological Diseases and Blindness were established under the authority of this act on November 22, 1950. Under this same act, the National Institute of Allergy and Infectious Diseases was established on December 29, 1955, replacing the National Microbiological Institute which was originally established November 1, 1948, under authority of section 202 of the PHS act.)
April 1, 1953—Reorganization plan #1 assigned the PHS to the new Department of Health, Education, and Welfare.
July 28, 1955—The Mental Health Study Act authorized the Surgeon General to award grants to non-governmental organizations for partial support of a nationwide study and reevaluation of the problems of mental illness. Under this act, the Joint Committee on Mental Illness and Health was awarded grant support for 3 years. (P.L. 84-182, 69 Stat. L. 381.)
July 3, 1956—The National Health Survey Act authorized the Surgeon General to survey sickness and disabilities in the United States on a sampling basis. (P.L. 84-652, 70 Stat. L. 489.)
July 28, 1956—The Alaska Mental Health Enabling Act provided for territorial treatment facilities to eliminate the need to transport the mentally ill outside Alaska. It also authorized PHS grants to Alaska for its mental health program. (P.L. 84-830, 70 Stat. L. 709.)
July 30, 1956—The Health Research Facilities Act of 1956 (Title VII of the PHS act) authorized a PHS program of Federal matching grants to public and nonprofit institutions for the construction of health research facilities. (P.L. 84-835, 70 Stat. L. 717.)
August 2, 1956—The Health Amendments Act of 1956 authorized the Surgeon General to assist in increasing the number of adequately trained nurses and professional public health personnel. It also authorized PHS grants to support the development of improved methods of care and treatment of the mentally ill. (P.L. 84-911, 70 Stat. L. 923.)
August 3, 1956—An amendment to Title III of the PHS act, the National Library of Medicine Act, placed the Armed Forces Medical Library under the PHS, and renamed it the National Library of Medicine. (P.L. 84-941.)
June 30, 1958—The Mutual Security Act of 1958 amended P.L. 83-480, authorizing the President to enter into agreements with friendly nations to use foreign currencies accruing under title I for collection, translation, and dissemination of scientific information and to conduct research and support scientific activities overseas. (P.L. 85-477.)
July 12, 1960—Congress passed the International Health Research Act. The law authorized the Surgeon General to establish and make grants for fellowships in the United States and participating foreign countries; make grants or loans of equipment and other materials to participating foreign countries for use by public or nonprofit institutions and agencies; participate in international health meetings, conferences, and other activities; and facilitate the interchange of research scientists and experts between the United States and participating foreign countries. (P.L. 86-610, 74 Stat. L. 364.)
September 15, 1960—A law amended the PHS act to authorize grants-in-aid to universities, hospitals, laboratories, and other public and nonprofit institutions to strengthen their programs of research and research training in the sciences related to health. The act also authorized the use of funds appropriated for research or research training to be set aside by the Surgeon General in a special account for general research support grants. (P.L. 86-798, 74 Stat. L. 1053.)
October 17, 1962—An act authorized the Surgeon General to establish the National Institute of General Medical Sciences and the National Institute of Child Health and Human Development. The latter was authorized to conduct and support research and training relating to maternal health; child health; human development, in particular the special health problems of mothers and children; and the basic sciences relating to the processes of human growth and development. The former was authorized to conduct and support research in the basic medical sciences and related behavioral sciences that have significance for two or more institutes, or which are outside the general area of responsibility of any other institute. (P.L. 87-838, 76 Stat. L. 1072.) (On January 30, 1963, the NICHD and the NIGMS were established under this act.)
September 24, 1963—A law amended the Health Research Facilities Act of 1956 (Title VII to the PHS act) to allow grants for multipurpose facilities that would provide teaching space as well as essential research space. (P.L. 88-129, 77 Stat. L. 164.)
October 24, 1963—The Maternal and Child Health and Mental Retardation Planning Amendments of 1963 amended the Social Security Act of 1935 by authorizing a five-point grant program of $265 million, over a 5-year period. Major provisions designed to prevent mental retardation included increased Federal grants for maternal and child health services and crippled children's service administered by the Children's Bureau; a new 5-year program of grants to the states for health care of expectant mothers who have, or are likely to have, conditions associated with childbearing which may lead to mental retardation; funds for research to improve maternal and child health and crippled children's services; and grants to the states to assist in developing plans for comprehensive state and community programs to combat mental retardation. (P.L. 88-156, 77 Stat. L. 273.)
October 31, 1963—A companion measure to P.L. 88-156 was the Mental Retardation Facilities and Community Mental Health Centers Construction Act of 1963. This act authorized a total of $329 million over 5 years for grants to assist in the construction of mental retardation research centers and community mental health centers, and to train teachers of mentally retarded and other handicapped children. (P.L. 88-164, 77 Stat. L. 282.)
August 18, 1964—The Hospital and Medical Facilities Amendments of 1964 extended the Hospital Survey and Construction Act of 1946 (Hill-Burton Act) for 5 years with a total authorization of $1.4 billion. (P.L. 88-443, 78 Stat. L. 447.)
August 27, 1964—Graduate Public Health Training Amendments of 1964 extended the authorization for public health traineeships and training grants to schools of public health, nursing, and engineering for 5 years, through June 30, 1969. (P.L. 88-497, 78 Stat. L. 613.)
September 19, 1964—The Appropriations Act for 1965 included $10 million for establishment of a virus-leukemia program. (P.L. 88-605.)
August 4, 1965—The Mental Retardation Facilities and Community Mental Health Centers Construction Act Amendments of 1965 provided monies through FY 1972 to help finance initial staffing of community mental health centers which were authorized in the original act; extended and increased appropriations authority for mental retardation education research and demonstration projects; and authorized increased annual funds through FY 1969 for training teachers of the handicapped young. (P.L. 89-105.)
August 9, 1965—The Health Research Facilities Amendments of 1965 extended the program for construction of health research facilities for 3 years with $280 million authorized for that period in lieu of the previous $50 million annual appropriations authorizations. (P.L. 89-115.)
August 31, 1965—A supplemental appropriations act resulting from recommendations of the President's Commission on Heart Disease, Cancer and Stroke provided an additional $20,250,000 (shared by NCI, NHI, NIGMS and NINDB) to intensify and expand support of research in the three major "killer" diseases. (P.L. 89-156.)
October 6, 1965—The Heart Disease, Cancer and Stroke Amendments of 1965 provided for establishment of regional cooperative programs in research, training, continuing education and demonstration activities in patient care among medical schools, clinical research institutions and hospitals so that the latest treatment methods for the three diseases may be more widely available to patients. Under this act, the Division of Regional Medical Programs was created February 1, 1966. (P.L. 89-239.)
October 22, 1965—The Medical Library Assistance Act was passed, authorizing NLM's extramural programs. (P.L. 89-291.)
August 3, 1968—A law authorized the designation of a national center for biomedical communications as the Lister Hill National Center for Biomedical Communications. (P.L. 90-456.)
August 16, 1968—An amendment to the PHS act authorized the secretary to establish a National Eye Institute and to rename NINDB the National Institute of Neurological Diseases. The new institute was formed from NINDB programs to conduct and support research for new treatment and cures, and training relating to blinding eye diseases and visual disorders. (P.L. 90-489.)
The Health Manpower Act of 1968 extended and expanded the following five health laws then in effect: Health Professions Educational Assistance Act of 1963, as amended; Nurse Training Act of 1964, as amended; Allied Health Professions Personnel Training Act of 1966; Health Research Facilities Act of 1956, as amended; and Public Health Service Act of 1944, as amended. The measure provided a 2-year extension, through FY 1971, of the above legislation except for the Allied Health Professions Act, extended only through FY 1970. (P.L. 90-490.)
October 24, 1968—The President signed legislation further amending the name of NIND to National Institute of Neurological Diseases and Stroke. (P.L. 90-639.)
March 12, 1970—An amendment to the PHS act extended and made coterminous through June 30, 1973, the authority to make formula grants to schools of public health, project grants for graduate training in public health, and traineeships for professional public health personnel. (P.L. 91-208, 84 Stat. 52.)
March 13, 1970—The Medical Library Assistance Extension Act of 1970 amended the PHS act to improve and extend the provisions relating to assistance to medical libraries and related instrumentalities for 3 years through June 30, 1973. (P.L. 91-212, 84 Stat. 63.)
October 30, 1970—The PHS act was amended to provide: 1) extension of research contract authority in areas of public health through June 30, 1974; 2) authorization of mission-related clinical training (as well as research training) by the NIGMS; 3) clarification of terms in the regulation of biological products; 4) clarifying and technical directives relating to appointment, compensation and functions of advisory councils and committees, and 5) extension of statutory authority for regional medical programs, comprehensive medical planning, and health services research and development. (P.L. 91-515.)
November 2, 1970—The Health Training Improvement Act of 1970 extended and amended allied health professions training authority (which expired June 30, 1970) and established eligibility of new health professions educational assistance schools for "start-up" grants. (P.L. 91-519.)
December 24, 1970—The Congress enacted the Family Planning Services and Population Research Act of 1970 to expand, improve and better coordinate family planning services and population research activities of the Federal Government. (P.L. 91-572.)
May 22, 1971—Congress passed into law the Supplemental Appropriations Bill, which included $100 million for cancer research. This appropriation was made in response to the President's State of the Union address, in which he called for "an intensive campaign to find a cure for cancer." The appropriation includes authority under grants and contracts, as well as direct construction authority for NCI. (P.L. 92-18.)
July 9, 1971—A law amended the Public Health Service Act to provide for extension of student loan scholarship programs for up to four fiscal years. (P.L. 92-52.)
November 18, 1971—The President signed the Comprehensive Health Manpower Training Act of 1971 to provide increased manpower in the health professions, and the Nurse Training Act of 1971 to provide training for increased numbers of nurses. (P.L. 92-157, P.L. 92-158.)
December 23, 1971—The National Cancer Act of 1971 enlarged the authorities of NCI and NIH in order to advance the national effort against cancer. The authority of the director, NCI, was expanded, a National Cancer Advisory Board was established, and appropriations in excess of $400 million were authorized for 1972, with further increases in subsequent years. (P.L. 92-218.)
May 16, 1972—The National Sickle Cell Anemia Control Act of 1972 became law and established a national program for diagnosis and treatment of, and counseling and research in, sickle cell disease. (P.L. 92-294.)
May 19, 1972—The need for further support of research and training in the field of digestive diseases was emphasized by adding a new section 434 to the PHS act and renaming NIAMD the National Institute of Arthritis, Metabolism, and Digestive Diseases. (P.L. 92-305.)
August 29, 1972—The National Cooley's Anemia Control Act authorized over $9 million for 3 years for research in the diagnosis and treatment of Cooley's anemia, and for counseling and public information programs. (P.L. 92-414.)
September 19, 1972—The National Heart, Blood Vessel, Lung, and Blood Act expanded the authorities of the National Heart and Lung Institute to augment the national effort against heart, lung, and blood diseases. Appropriations of $375 million for 1973 were authorized with further increases in subsequent years. (P.L. 92-423.)
October 25, 1972—The National Advisory Commission on Multiple Sclerosis Act established a commission charged to determine the most productive avenue of researching possible causes and cures of MS, and make specific recommendations for the maximum utilization of national resources directed toward MS. (P.L. 92-563.)
June 18, 1973—The Health Programs Extension Act of 1973 extended the medical library assistance programs of NLM (with the exception of the construction program) for 1 year. Population research and family planning activities were also extended through FY 1974, along with other Federal health programs. (P.L. 93-45.)
November 16, 1973—The Emergency Medical Services System Act of 1973 amended the PHS act to provide assistance and encouragement for the development of comprehensive area emergency medical services systems, including grants and contracts for the support of research in emergency medical techniques, methods, devices, and delivery. (P.L. 93-154.)
April 22, 1974—The Sudden Infant Death Syndrome Act of 1974 amended the PHS act to authorize specific and general research on the sudden infant death syndrome through the NICHD. The collection, analysis, and public dissemination of information and data and the support of counseling programs were also authorized. The act did not authorize specific funds for research, but did authorize appropriations of $9 million over a 3-year period for the other programs. (P.L. 93-270.)
May 31, 1974—The Research on Aging Act of 1974 established a National Institute on Aging. The act authorized the NIA to conduct and support biomedical, social, and behavioral research and training related to the aging process and the diseases and other special problems and needs of the aged. (P.L. 93-296.)
June 22, 1974—The Energy Supply and Coordination Act directed the secretary through NIEHS to study the effects of chronic exposure to sulfur oxides, and authorized $3.5 million for that purpose. (P.L. 93-319.)
July 12, 1974—The National Research Act of 1974 amended the PHS act by repealing existing research training and fellowship authorities and consolidating such authorities in the national research service awards authority. The NRSAs (both individual and institutional grants) are restricted on the basis of subject area shortages and would involve service obligations and payback provisions. The act established a temporary National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research within the department to make a comprehensive investigation of the ethical principles involved in biomedical and behavioral research (including psychosurgery and living fetus research), and to develop ethical guidelines for conducting such research. Also, a permanent National Advisory Council for the Protection of Subjects of Biomedical and Behavioral Research was to be established. (P.L. 93-348.)
July 23, 1974—The National Cancer Act Amendments of 1974 authorized $2.565 billion over a 3-year period to extend and improve the National Cancer Program as well as $210.5 million over 3 years for cancer control programs. The act also: 1) established the President's Biomedical Research Panel to make a comprehensive investigation of Federal biomedical and behavioral research; 2) extended indefinitely the research contract authority of section 301(h) of the PHS act; 3) provided that the director, NIH, shall be appointed by the President by and with the advice of the Senate; and 4) required peer review of NIH and ADAMHA grant applications and contract projects. (P.L. 93-352.)
The Health Services Research, Health Statistics, and Medical Libraries Act of 1974 extended and amended NLM program authorities ($37.5 million over a 2-year period). The act also extended the FIC's authority to engage in international cooperative efforts in health. (P.L. 93-353.)
The National Diabetes Mellitus Research and Education Act provided for regional research and training centers ($40 million authorized over a 3-year period), a long-range plan prepared by a National Commission on Diabetes, expanded research and training programs, a Diabetes Mellitus Coordinating Committee, and an associate director for diabetes in the National Institute of Arthritis, Metabolism, and Digestive Diseases. (P.L. 93-354.)
October 29, 1974—The Federal Fire Prevention and Control Act authorized $5 million and $8 million for fiscal years 1975-76 for establishment of 25 research and treatment centers, 25 burn units, and 90 burn programs by NIH. (P.L. 93-498.)
January 4, 1975—The National Arthritis Act established a National Commission on Arthritis and Related Musculoskeletal Diseases, authorized $2 million to develop a long-range plan involving research, training, services and data systems; established an associate director for arthritis in NIAMDD; and provided 3-year authorizations for arthritis screening, detection, prevention, and referral projects and for arthritis research and demonstration centers. (P.L. 93-640.)
July 29, 1975—A law extended and amended authorities of Title X relating to family planning and population research and made Title X sole authority for all departmental extramural, collaborative, and intramural research in "biomedical, contraceptive development, behavioral, and program implementation fields related to family planning and population;" and created two temporary national commissions for the control of epilepsy and Huntington's disease. (P.L. 94-63.)
April 22, 1976—The Health Research and Health Services Amendments 1) extended authorization through FY 1977 and amended provisions governing the programs of the National Heart and Lung Institute, placed increased emphasis on blood-related research, and changed the institute's name to the National Heart, Lung, and Blood Institute; 2) mandated studies by the President's Biomedical Research Panel and the National Commission for the Protection of Human Subjects of the implications of public disclosure of information contained in grant applications and contract proposals; 3) authorized broad-based genetic diseases research under section 301 of the PHS act, and provided for programs of counseling, testing, and information dissemination about genetically transmitted diseases; and 4) extended authorization through FY 1977 for national research service awards for NIH and ADAMHA. The act prohibited consideration of political affiliation in making appointments to health advisory committees. (P.L. 94-278.)
October 19, 1976—The 1976 Arthritis, Diabetes, and Digestive Diseases Amendments 1) provided for an arthritis data system; 2) emphasized public information and encouragement of proper treatment for arthritis; 3) established a National Arthritis Advisory Board; 4) provided for a National Diabetes Board; and 5) established a National Commission on Digestive Diseases to develop a long-range plan for research. (P.L. 94-562.)
October 21, 1976—The Emergency Medical Services Amendments of 1976 extended the National Commission on Arthritis; extended the Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; and authorized research and demonstration programs on burn injuries under Title XII of the PHS act. (P.L. 94-573.)
August 1, 1977—Health Planning and Health Services Research and Statistics Extension, Biomedical Research Extension, and Health Services Extension Acts of 1977 continued the following programs through September 30, 1978: the Medical Library Assistance Program; cancer research and control programs; heart, blood vessel, lung and blood disease research, prevention and control programs; national research service awards; population research and voluntary family planning programs; and sudden infant death syndrome information and counseling programs. It also extended various health service programs. (P.L. 95-83.)
August 7, 1977—The Clean Air Act Amendments established a coordinating committee to review and comment on plans, execution, and results of research relating to the stratosphere. NCI and NIEHS are members. It also established a Task Force on Environmental Cancer and Heart and Lung Disease, with NCI, NHLBI, and NIEHS among the members. (P.L. 95-95.)
September 29, 1977—The Food and Agriculture Act of 1977 designated the Department of Agriculture as the lead agency of the Federal Government for agricultural research (except with respect to the biomedical aspects of human nutrition concerned with diagnosis or treatment of disease). The act also required establishment of procedures for coordinating nutrition research in areas of mutual interest between DHEW and Department of Agriculture. (P.L. 95-113.)
November 9, 1977—The Federal Mine Safety and Health Amendments of 1977 gave the HEW secretary authority to appoint an advisory committee on coal or other mine health research. One member of this committee is to be the director of the NIH or delegate. (P.L. 95-164.)
November 23, 1977—The Saccharin Study and Labeling Act extended the Commission for the Protection of Human Subjects until November 1, 1978. (P.L. 95-203.)
November 9, 1978—The Family Planning, Population Research and SIDS Amendments authorized a 3-year extension for the aforementioned programs through FY 1981. This was the only authority for population research programs in NICHD, the Center for Population Research. (P.L. 95-613.)
Amendments to the Community Mental Health Centers Act authorized a 3-year extension for NLM programs, and NRSA's expiring September 30, 1981, and a 2-year extension for each of the following: Community Mental Health Centers, NHLBI, and NCI. This legislation also authorized the secretary, HEW, to: 1) conduct studies and tests of substances for carcinogenicity, teratogenicity, mutagenicity and other harmful biological effects; 2) establish and conduct a comprehensive research program on the biological effects of low-level radiation; 3) conduct and support research and studies on human nutrition; and 4) publish an annual report which lists all substances known to be carcinogenic and to which a significant number of Americans are exposed. (P.L. 95-622.)
Other important provisions of this act included the authority given to the director of NIH to appoint 200 experts and consultants for the use of NIH components other than NCI and NHLBI and the establishment of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.
The Health Services Research, Health Statistics, and Health Care Technology Act of 1978 (P.L. 95-623) established in the Office of the Assistant Secretary for Health, the National Center for Health Care Technology, and reauthorized for 3 years the National Center for Health Statistics and the National Center for Health Services Research.
The legislation also established the National Council on Health Care Technology on which the director, NIH, serves as an ex officio member. The director, NIH, is required annually to submit to the center a listing of all technologies under development which appear likely to be used in the practice of medicine.
NLM is required to disseminate, publish, and make available all standards, norms, and criteria developed by the council concerning the use of particular health care technologies. (P.L. 95-623.)
October 17, 1979—The Department of Education Organization Act established a Department of Education and renamed the DHEW the Department of Health and Human Services. (P.L. 96-88.)
December 12, 1979—The Emergency Medical Services Systems Amendments and Sudden Infant Death Syndrome Amendments of 1979 required the NICHD to assure that "adequate amounts" of its appropriated dollars are used for research into identification of infants at risk of SIDS and for prevention of SIDS. In addition, the NICHD is required to provide information on expenditure of funds for these purposes, the number of SIDS grant applications received and approved, the latest research findings on SIDS, and estimate of needs for funds in succeeding years. (P.L. 96-142.)
December 29, 1979—P.L. 96-167 extended the tax exemption for NRSA's for 1 year.
P.L. 96-171 required that the NIH Director, in consultation with the secretary of transportation, conduct a study to determine the effect of aging on the ability of individuals to perform the duties of pilots. The report on the study was to be submitted to Congress within 1 year after enactment.
September 26, 1980—P.L. 96-359 requires the HHS secretary to conduct a study to determine the long-term effects of hypochloremic metabolic ankylosis resulting from chloride-deficient formulas. The responsibility for the study was assigned to NICHD.
December 12, 1980—P.L. 96-517 revised the patent and trademark laws and in particular awarded title to the patent rights for inventions made with Federal assistance to nonprofit organizations and small businesses.
The Clinical Center was redesignated as the Warren Grant Magnuson Clinical Center of NIH. (P.L. 96-518.)
December 17, 1980—P.L. 96-538 reauthorized for 2 years programs for NHLBI and NCI; changed the name of the NIAMDD to the National Institute of Arthritis, Diabetes, and Digestive and Kidney Diseases, extensively revised its authorities, and reauthorized its programs for 3 years; and required the NINCDS to conduct a study and submit a report on spinal cord regeneration and other neurological research.
P.L. 96-541 extended for 1 year the tax exemption on NRSAs.
August 13, 1981—P.L. 97-35, the Omnibus Budget Reconciliation Act of 1981, reauthorized NRSAs for 2 years through FY 1983, reauthorized the Medical Libraries Assistance program for 1 year, and repealed the prohibition in Title X against using other PHS authority to fund population research, thus eliminating the need for reauthorizations for this program located in the NICHD.
July 22, 1982—The Small Business Innovation Development Act of 1982 requires that each Federal agency with an annual research and development budget exceeding $100 million set aside a certain portion of its extramural R&D budget for a Small Business Innovation Research (SBIR) program as follows: 0.2 percent in FY 1983; 0.6 percent in FY 1984; 1.0 percent in FY 1985; and 1.25 percent in FY 1986 and all subsequent years. (P.L. 97-219.)
September 3, 1982—The Tax Equity and Fiscal Responsibility Act of 1982 included among its provisions an extension of the partial exclusion of NRSAs from taxable gross income. This extension will expire at the end of calendar year 1983; during this time, the Treasury Department will complete a study of the taxability of NRSA's and other government educational grants which, like NRSA's, have payback or service requirements. (P.L. 97-248.)
January 4, 1983—The Orphan Drug Act made changes in the law to encourage development and marketing of orphan drugs (drugs for rare diseases or conditions which are not economically feasible for private industry to develop and market). The act included a requirement to prepare radioepidemiological tables relating radiation-related cancer to specific radiation doses, and a report on the risks of thyroid cancer associated with doses of I131. These responsibilities were assigned to NIH and NCI respectively. The act further provided that NHLBI help develop and support not less than 10 comprehensive sickle cell centers. (P.L. 97-414.)
July 30, 1983—The supplemental appropriations for FY 1983 provided funds for PHS AIDS activities, $9.375 million of which was earmarked for NIH. This marked the first time the Congress directly appropriated money for AIDS research for NIH. The supplemental also provided $5.9 million for NLM and development of a Biomedical Information Communication Center in Portland, Oreg. (P.L. 98-63.).
October 1 and November 17, 1983—Continuing resolutions supported unauthorized NIH programs including NRSA and Medical Library Assistance. (P.L. 98-107 and P.L. 98-151.)
May 24, 1984—P.L. 98-297 designated the convent and surrounding land as the Mary Woodard Lasker Center for Health Research and Education.
October 12 and November 8, 1984—Appropriations legislation reauthorized NRSAs, provided construction funds for NIH, and medical library funding. (P.L. 98-473, P.L. 98-619.)
October 19, 1984—The National Organ Transplant Act authorized the secretary to establish a Task Force on Organ Procurement and Transplantation to examine relevant issues and report to the Congress within 12 months. Its membership included the director, NIH, ex officio. OMAR will sponsor the required conference on bone marrow transplantation. (P.L. 98-507.)
October 24, 1984—The Veterans' Dioxin and Radiation Exposure Compensation Standards Act required the director, NIH, to conduct a study of devices and techniques for determining previous radiation exposure and submit a report; to enter into an interagency agreement with the VA administrator to identify agencies capable of furnishing such services; and to provide an independent expert who could prepare radiation dose estimates for use by VA administrator in adjudicating claims. (P.L. 98-542.)
October 30, 1984—The Health Promotion and Disease Prevention Amendments of 1984 amended the PHS act to extend provisions relating to health promotion and disease prevention and to establish centers for research and demonstration in those areas. It required that the director, NIH, be consulted as to procedures for peer review of applications; that NCHSR cooperate with NIH in its responsibilities pertaining to health care technologies; and that the director, NIH, serve on the newly established National Advisory Council on Health Care Technology Assessment. (P.L. 98-551.)
The Human Services Reauthorization Act, Title V, ordered the secretary, through NCI, to establish or support at least one facility for cancer screening and research in St. George, Utah, to be affiliated with a health science center and accessible to most residents of the areas that received greatest fallout from Nevada nuclear tests. (P.L. 98-558.)
August 15, 1985—The Orphan Drug Act was amended, establishing a 20-member National Commission on Orphan Diseases, to be appointed by the secretary (including NIH representative), to assess the activities of NIH and other entities in connection with research and dissemination of knowledge related to rare diseases. NIH was required to allocate to the commission $1 million from its FY 1986 appropriation. (P.L. 99-91.)
November 20, 1985—The Health Research Extension Act of 1985 reauthorized NIH programs for 3 years; established the National Institute of Arthritis and Musculoskeletal and Skin Diseases, renaming the remaining component the National Institute of Diabetes and Digestive and Kidney Diseases; created a new National Center for Nursing Research; established positions of associate director for prevention in OD, NCI, NHLBI, and NICHD; and required the development of guidelines for the care and use of laboratory animals. Additional provisions included establishment of committees to develop a plan for research into methods that reduce animal use or animal pain, to study research on lupus erythematosus, to study the NRSA program, to plan and develop Federal initiatives in spinal cord injury research, to study personnel for health needs of the elderly through the year 2020, to review research activities in learning disabilities, and to review the research programs of NIDDK. The act also established NIH and all of its ICD's in law and consolidated and made uniform many authorities and responsibilities of institute directors and advisory councils. (P.L. 99-158.)
December 12, 1985—Under the Balanced Budget and Emergency Deficit Control Act of 1985 (Gramm-Rudman-Hollings), aimed at reducing the Federal deficit to zero within 5 years, starting in FY 1986, budget authority was reduced in accordance with the deficit targets. For NIH this reduction amounted to $236 million. The revised total NIH appropriation after "sequestration" became $5.3 billion, 4.3 percent below the original FY 1986 appropriation. The mandated across-the-board reduction was applied again to the total amount appropriated to each NIH institute, to each research mechanism, and to each identified program, project, or activity. (P.L. 99-177.)
In the FY 1986 Labor-HHS-Education Appropriation bill, the number of new and competing renewal research project grants to be supported by NIH (6,100) was specified in law for the first time. The act, which included $5.498 billion for NIH, provided that $4.5 million of this amount be transferred to the departmental management account for construction of the Mary Babb Randolph Cancer Center in West Virginia and that $70 million for AIDS research be added to the account of the Office of the Director. (P.L . 99-178.)
December 23, 1985—The Food Security Act, title XVII, subtitle F, amended the Animal Welfare Act, requiring the secretary of agriculture to promulgate standards including exercise of dogs and consideration of the psychological well-being of primates, minimization of pain and distress, use of anesthetics, and consideration of alternatives; formation of an institutional animal committee at each research facility; and provision of annual training for those involved in animal care and treatment. An information service was established at the National Agricultural Library, in cooperation with NLM. Title XIV, subtitle B, required an assessment of existing scientific literature relating to dietary cholesterol and calcium to be conducted by the secretaries of agriculture and HHS. (P.L. 99-198.)
December 28, 1985—P.L. 99-231 designated 1986 as the "Sesquicentennial Year of the National Library of Medicine."
July 2, 1986—The Urgent Supplemental Appropriations Act provided an additional $6 million for NCI cancer research and demonstration centers and specified that funds for the Clinical Center should be available for payment of nurses at rates of pay authorized for VA nurses. (P.L. 99-349.)
October 6, 1986—P.L. 99-443 amended the Small Business Act to extend by 5 years the Small Business Innovation Research Program.
October 16, 1986—P.L. 99-489 designated the period from October 1, 1986, through September 30, 1987, as "National Institutes of Health Centennial Year" and requested the President to issue a proclamation calling upon the people of the United States to observe the year with appropriate ceremonies and activities.
October 18, 1986—P.L. 99-500 and P.L. 99-591 (October 31, corrected version), making continuing appropriations for FY 1987, included $6.18 billion for NIH, a requirement to support 6,200 research project grants, funding for 10,700 research trainees and 559 centers; and $247.7 million in AIDS money for components.
October 20, 1986—The Federal Technology Transfer Act amended the Stevenson-Wydler Technology Innovation Act of 1980, authorizing directors of government-operated Federal laboratories to enter into collaborative R&D agreements with other government agencies, universities, and private organizations; established a Federal Laboratory Consortium in the National Bureau of Standards; and mandated that royalties received by a Federal agency be shared with the inventor. (P.L. 99-502.)
November 14, 1986—Title IX, the Alzheimer's Disease and Related Dementias Services Research Act, of P.L. 99-660 established an interagency council and an advisory panel on Alzheimer's disease (AD). It authorized the director, NIA, to make awards for distinguished research on AD, to plan for and conduct research, to establish an AD clearinghouse, to make a grant to or enter into a contract with a national organization representing Alzheimer's patients, to establish an information system and national toll-free telephone line, and to provide information to caregivers of Alzheimer's patients and to safety and transportation personnel. Title III—Vaccine Compensation—named the director, NIH, as an ex officio member of the newly established Advisory Commission on Childhood Vaccines.
July 11, 1987—The FY 1987 Supplemental Appropriations bill, P.L. 100-71, allocated funds to NIA for clinical trials, to NCNR and HRSA for studies related to the nurse shortage and nurse retention, and to OD/NIH for costs associated with pay raises and the new Federal Employees Retirement System.
September 29, 1987—The Balanced Budget and Emergency Deficit Control Reaffirmation Act of 1987 ("Gramm-Rudman-Hollings II") adjusted the original deficit target reduction in FY 1988 appropriations, including Labor-HHS-Education. (P.L. 100-119.)
October 8, 1987—P.L. 100-126 designated October 1, 1987, as "National Medical Research Day," acknowledging 100 years of contributions by NIH and other federally supported research institutions to improving the health and well-being of Americans and all humankind.
November 29, 1987—The Older Americans Act Amendments, Title III—Alzheimer's Disease Research, authorized the director, NIA, to provide for conduct of clinical trials on therapeutic agents for Alzheimer's disease recommended for further analysis by NIA and FDA. It also authorized the President to call a White House Conference on Aging in 1991. (P.L. 100-175.)
December 22, 1987—P.L. 100-202, making further continuing appropriations for the fiscal year ending September 30, 1988, provided $6.667 billion to NIH, including $448 million to be allocated among the institutes for AIDS. It also restricted forward or multiyear funding, required expeditious testing of experimental drugs for AIDS, and included $3.8 million for a National Center on Biotechnology Information within NLM.
September 20, 1988—The Labor-HHS-Education Appropriations Act, 1989, provided $7,152,207,000 for NIH (which included a 1.2 percent across-the-board reduction and a $6.8 million reduction for procurement reform). Of the amount appropriated for NINCDS, up to $96,100,000 was to go to the new National Institute on Deafness and Other Communication Disorders, following enactment of authorizing legislation. The pay rate for NIH nurses and allied health specialists having direct patient care responsibilities was equated to that of nurses at the Veterans Administration. Fifteen million dollars was appropriated to develop specifications and design for a consolidated office building at NIH, $14 million for the new Building 49, and $5 million for renovation of AIDS facilities. In addition, a biotechnology training program was established, as well as human genome and biotechnology panels.
Funds were authorized to support no less than 13,252 FTEs, including an additional 200 for AIDS and 150 for non-AIDS. Funding was also authorized for new magnetic resonance imaging equipment at the cardiac energetic laboratory and for a National Bone Marrow Registry at NHLBI; $8.7 million was earmarked for AIDS clinical trials.
Building 31 was renamed the Claude Denson Pepper Building. (P.L. 100-436.)
September 22, 1988—The Treasury, Postal Service and General Government Appropriations Act, 1989, provided that no Federal agency could receive funds appropriated for FY 1989 unless it had in place a written policy ensuring that its workplaces were free from illegal use, possession, or distribution of controlled substances. This restriction also applied to grant recipients, contractors, and parties to other agreements. (Subsequent legislation required implementation of this law in January 1989.) (P.L . 100-440.)
September 29, 1988—The National Defense Authorization Act, FY 1989, provided a special pay retention bonus for medical officers below grade O-7 who met certain criteria. Although officers of the commissioned corps were not specifically mentioned, 42 U.S.C. 210(a) states that they shall receive special pay received by commissioned medical and dental officers of the Armed Forces. (P.L. 100-456.)
October 4, 1988—P.L. 100-471 amended the PHS act to authorize the secretary, HHS, to make grants to the states to provide drugs determined to prolong the life of individuals suffering from AIDS; $15 million was authorized to be appropriated through March 31, 1989. (Funds appropriated for FY 1989 were transferred from NIH and other PHS agencies to pay for this program, according to transfer authority contained in P.L. 100-436.)
October 28, 1988—The National Deafness and Other Communication Disorders Act of 1988 established that institute at NIH and renamed NINCDS the National Institute of Neurological Disorders and Stroke. The legislation included a program, a data system and information clearinghouse, centers, and an advisory board, as well as a Deafness and Other Communication Disorders Interagency Coordinating Committee, to be chaired by the director of NIH or designee. (P.L. 100-553.)
November 4, 1988—Title I of the Health Omnibus Programs Extension of 1988 (HOPE), the National Institute on Deafness and Other Communication Disorders and Health Research Extension Act of 1988, established the NIDCD and reauthorized expiring programs of NIH for 2 years. Since the new institute had already been established by P.L. 100-553, the provision in this bill is not valid. (P.L. 100-607)
A National Center for Biotechnology Information was established in the National Library of Medicine; the provision for VA pay for nurses and allied health professionals was reiterated; NCI, NHLBI, and NRSA programs were reauthorized; responsibility for the primary care training program was shifted to HRSA; the Interagency Technical Committee was abolished; the Alzheimer's disease provisions of P.L. 99-660 were shifted to the NIA section of the PHS act; the moratorium on fetal research was extended through November 4, 1990; funds were appropriated for the Biomedical Ethics Advisory Board and a report specified; the secretary was directed to consult with the director, NIH, on establishment of a National Commission on Sleep Disorders, which would include among the ex officio members the directors of NINCDS, NHLBI, NIMH, NIA, and NICHD, with a report and a plan required. Finally, the bill extended confidentiality provisions to subjects of all biomedical, behavioral, clinical, or other research, including research on mental health.
Title II, "Programs with Respect to Acquired Immune Deficiency Syndrome," laid the foundation for a Federal policy on AIDS. In addition to provisions for AIDS research, the bill included provisions for information dissemination, education, prevention, anonymous testing, and establishment of a National Commission on AIDS. The review process for AIDS-related grants was expedited, provision was made for priority requests for personnel and administrative support, a clinical research review committee was established within NIAID, the AIDS outpatient capacity at the Clinical Center was doubled, community-based clinical trials were mandated, awards for international clinical research were authorized, research centers were supported, and information services were expanded. An Office of AIDS Research was established within OD. Title VI, the Health Professions Reauthorization Act of 1988, established a loan repayment program for scientists who agree to conduct AIDS research while employed at NIH. (P.L. 100-607.)
November 21, 1989—Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 1990, provided for the purchase of an advanced design supercomputer and named four NIH buildings for members of Congress. (P. L. 101-166)
November 29, 1989—An act to provide for the construction of biomedical facilities in order to ensure a continued supply of specialized strains of mice essential to biomedical research in the United States, and for other purposes, provided authority to make construction grants for this purpose. (P.L. 100-190)
August 18, 1990—Ryan White Comprehensive AIDS Resources Emergency Act of 1990, authorized NIH to make demonstration grants to community health centers and other entities providing primary health care and servicing a significant number of pediatric patients and pregnant women with HIV disease. Awardees were to provide clinical data to NIH for evaluation. (P.L. 101-381)
November 5, 1990—Omnibus Budget Reconciliation Act of Response, Compensation, and Liability Act of 1980 (under which NIEHS operates some programs) and called on the secretary, with NCI, to review periodically the appropriate frequency for performing screening mammography.
Treasury, Postal Service and General Government Appropriations Act, 1991, established the PHS senior biomedical research service. (P.L. 101-509)
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 1991, provided for the first time, a 1 percent NIH director's transfer authority for high-priority activities and capped the NIH contribution for salaries for individuals receiving extramural funding. (P.L. 101-517)
November 15, 1990—Clean Air Act Amendments of 1990, required NIEHS to conduct a study of mercury exposure; to be available, with NCI, for membership on a panel for the Mickey Leland Urban Air Toxics Research Center and an inter-agency task force on air pollution; and authorized an NIEHS program of basic research on human health risks from air pollutants. (P.L. 101-549)
Home Health Care and Alzheimer's Disease Amendments of 1990, broadened the authority for Alzheimer's disease research centers and authorized Claude D. Pepper Older Americans Independence Centers grants. (P.L. 101-557)
November 16, 1990—The NIH Amendments of 1990, had two purposes: it authorized a nonprofit organization the National Foundation for Biomedical Research (membership amended by P.L. 102-170) and created NICHD's National Center for Medical Rehabilitation Research. (P.L. 101-613)
Hazardous Materials Transportation Uniform Safety Act of 1990, authorized NIEHS to provide grants for the training and education of workers who are or may be engaged in activities related to hazardous waste removal, containment or emergency response. (P.L. 101-615)
Transplant Amendments of 1990, reauthorized and amended the PHS act as it concerns the National Bone Marrow Donor Registry in the NHLBI and called for the establishment of national standards and procedures. (P.L. 101-616)
August 14, 1991—Terry Beirn Community Based AIDS Research Initiative Act of 1991, authorized this initiative in the PHS act and NIAID. (P.L. 102-96)
November 26, 1991—Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 1992, established NCI's Matsunaga-Conte Prostate Cancer Research Center, a women's health study, and provided authority to transfer funds to emergency activities. (P.L. 102-170)
December 9, 1991—The High Performance Computing Act of 1991, authorized Federal agencies such as NIH to allow recipients of research grant funds to pay for computer networking expenses. (P.L. 102-194)
February 4, 1992—The American Technology Preeminence Act of 1991 gave authority to the directors of Federal laboratories (NIH) to give research equipment that is excess to the needs of the laboratory to an educational institution or nonprofit organization for the conduct of technical and scientific education and research activities (P.L. 102-245)
July 10, 1992—The Alcohol, Drug Abuse, and Mental Health (ADAMHA) Reorganization Act, amended by the PHS act to provide for the incorporation of the three ADAMHA research institutes —NIMH, NIAAA, and NIDA—into the NIH as of October 1, 1992. A new PHS act section 409 was added and defined "health services research" as research endeavors that study the impact of organization, financing, and management of health services of the quality, cost, access to and outcomes of care. This is an entirely new programmatic undertaking for NIH and these three new institutes. Of particular interest are provisions that authorize a bypass budget for these three institutes for FY 1994 and 1995. (P.L. 102-321)
October 13, 1992—The DES Education and Research Amendments of 1992, require the director, NIH, to establish a program for the conduct and support of research and training, dissemination of health information, and other programs with respect to the diagnosis and treatment of conditions associated with exposure to DES. (P.L. 102-409)
The Agency for Health Care Policy and Research Reauthorization Act of 1992, requires that the NLM establish an information center on health service research, and on selected technology assessments and clinical practice guidelines produced by AHCPR and other public and private sources. The AHCPR administrator, in consultation with the NLM director, is required to develop and publish criteria for the inclusion of practice guidelines and technology assessments in the information center database. (P.L. 102-410)
October 24, 1992—The Cancer Registries Act requires the establishment of a national program of cancer registries, with the overall goal being the assurance of minimal standards for quality and completeness of (cancer) case information. Provisions also require the DHHS secretary, acting through the NCI director, to conduct a study for the purpose of determining the factors contributing to the fact that breast cancer mortality rates in 9 states and the District of Columbia are elevated compared to rates in the other 43 states. (P.L. 102-515)
The Energy Policy Act of 1992 authorizes electric and magnetic fields research and public information activities by the NIEHS director. (P.L. 102-486)
October 26, 1992—The Preventive Health Amendments of 1992 provide authorities regarding the coordination of Federal programs related to preventable cases of infertility arising as a result of sexually transmitted diseases; also delineates coordination between the director, CDC, and director, NIH. (P.L. 102-531)
October 28, 1992—The Small Business Innovation Research and Development and Enhancement Act of 1992 reauthorizes the SBIR program through September 30, 2000, and increases set aside percentages for each Federal agency with an extramural budget for research and development in excess of $100 million in FY 1992 (1.25 percent) upward to 2.5 percent by 1997 and onward. Legislation also requires enhancement of agency outreach efforts to increase participation of women-owned and socially and economically disadvantaged small business concerns, and tracking of awards to document their participation in the program. (P.L. 102-564)
The Housing and Community Development Act of 1992 requires the secretary, HHS, acting through the director, CDC, and director, NIEHS, to jointly conduct a study of the sources of lead exposure in children who have elevated blood lead levels (or other indicators of elevated lead body burden) as defined by the director, CDC. (P.L. 102-550)
November 4, 1992—The National Aeronautics and Space Administration (NASA) Authorization Act includes provisions offered as an amendment requiring NIH and NASA to jointly establish a working group, with equal representation from NASA and NIH, to coordinate biomedical research activities in areas where microgravity environment may contribute to significant progress in the understanding and treatment of diseases and other medical conditions; establishment of a joint program of biomedical research grants in the above described areas, where such research requires access to a microgravity environment, and annual issuance of joint research opportunity announcements; creation of a joint program of graduate research fellowships in biomedical research; and establishment and submission of a plan for the "conduct of joint biomedical research activities by the republics of the former Soviet Union and the United States." (P.L. 102-588)
June 10, 1993—The NIH Revitalization Act of 1993 reauthorized certain expiring authorities of the NIH; mandated establishment of the Office of Research Integrity in DHHS; lifted the moratorium on human fetal tissue transplantation research; mandated inclusion of women and minorities in clinical research protocols; created in statute the Office of Alternative Medicine, the Office of Research on Women's Health, the Office of Research on Minority Health, the Office of Biobehavioral and Social Sciences Research, and the National Center for Human Genome Research; mandated establishment of an intramural laboratory and clinical research program on obstetrics and gynecology within NICHD and the National Center on Sleep Disorders Research in NHLBI; codified in statute the establishment of the Office of AIDS Research, and strengthened and expanded its authorities, including authorizing OAR receipt of all appropriated AIDS funds for distribution to the ICs; authorized the establishment of an NIH director's discretionary fund; provided the director, NIH, with extramural construction authority; required from extramural construction funds a $5 million set aside for Centers of Excellence; mandated establishment of the IDeA program; required the NCI to conduct the Long Island breast cancer study; authorized establishment of scholarship and loan repayment programs for individuals from disadvantaged backgrounds; changed the designation from center to institute for NINR and from division to center for the Division of Blood Resources, NHLBI; and provided other new NIH authorities and directives. (P.L. 103-43)
August 3, 1993—The Government Performance and Results Act of 1993 seeks to curb fraud waste and mismanagement in the operation of the Federal Government by establishing performance standards. (P.L. 103-62)
December 14, 1993—The Preventive Health Amendments of 1993 required the director, NIAID, to conduct or support research and research training regarding the cause, early detection, prevention and treatment of tuberculosis, and authorized to be appropriated $50 million for FY 1994 and such sums as necessary for FYs 1995-98. (P.L. 103-183)
September 30, 1994—The Department of Labor, HHS, and Education Appropriations Act, 1995, provided for the first time a consolidated appropriation for NIH AIDS research to the Office of AIDS Research. (P.L. 103-333)
October 25, 1994—The Dietary Supplement Health and Education Act of 1993 mandated establishment of an Office of Dietary Supplements within NIH to conduct and coordinate NIH research relating to dietary supplements and the extent to which their use reduces the risk of certain diseases. (P.L. 103-417)
May 22, 1995—The Paperwork Reduction Act of 1995 amends the U.S. Code to reduce by 5 percent the Federal paperwork burdens imposed on individuals, small businesses, state and local governments, education and nonprofit institutions and Federal contractors; also had the effect of establishing in statute the NIH Office of Information Resources Management. (P.L. 104-13)
December 21, 1995—The Federal Reports Elimination and Sunset Act of 1995 provides for improvement of the efficiency of agency operations by reducing staff time and resources spent on producing "unnecessary" reports to Congress. (P.L. 104-66)
November 1, 1995—The Biotechnology Process Patents Protection Act of 1995 strengthens patent protection and clarifies the circumstances under which a patent using biotechnological processes can be issued; allows U.S. researchers to enforce their patents claiming a certain starting material against the unfair importation of products made overseas using such material; and stops international theft of intellectual property; and makes U.S. patent law consistent with that of the Europeans and the Japanese. (P.L. 104-41)
January 26, 1996—The Balanced Budget Downpayment Act I, a continuing resolution, contained an amendment prohibiting the use of NIH funds for human embryo research; and cited NIH's FY 1996 funding in P.L. 104-91, such that the prohibition would continue for the duration of the FY 1996 funding year. (P.L. 104-99)
March 7, 1996—The National Technology Transfer and Advancement act of 1995 amended the Stevenson-Wydler Technology Innovation Act of 1980 with respect to reinvention made under Cooperative Research and Development Agreements; addressed the assignment of intellectual property rights and the use and deregulation of royalty income. (P.L. 104-113)
April 24, 1996—The Antiterrorism and Effective Death Penalty Act of 1996 required that the Secretary, HHS, establish safety procedures for use of biological agents, training in handling and proper laboratory containment, safeguards to prevent their use for criminal purposes, and procedures to protect the public safety. The act provided, however, that the Secretary must ensure availability of biological agents for research purposes. (P.L. 104-132)
May 20, 1996—The Ryan White CARE Reauthorization Act revised and extended authorization of the 1990 act, which provided for care and services for persons living with HIV/AIDS. Title IV provisions require the administrator, HRSA, to consult with the director, NIH, in carrying out a grants program to provide health care and opportunities for women, infants, children, and youth to participate as voluntary subjects of clinical research on HIV disease that is of potential benefit to them. (P.L. 104-146)
July 29, 1996—The Traumatic Brain Injury Act amended the PHS Act to provide for the conduct of expanded studies and establishment of innovative programs with respect to traumatic brain injury. The act authorizes the Secretary, acting through the director, NIH, to award grants or contracts for the conduct of basic and applied research regarding traumatic brain injury. (P.L. 104-166)
August 6, 1996—The Safe Drinking Water Act amendments reauthorized the Safe Drinking Water Act, toughened standards and required the Environmental Protection Agency to consult with NIH and the CDC in announcing an interim national primary drinking water regulation for a contaminant in the case of an urgent threat to public health. (P.L. 104-182)
October 2, 1996—The Electronic Freedom of Information Act established the right of the public to obtain access to Agency records, including electronically stored documents, and requires Federal agencies to make available certain Agency information to the public for inspection and copying. (P.L. 104-231)
October 18, 1996—The General Accounting Office Management Reform Act amended the PHS Act to limit the amount NIH may obligate for administrative expenses each fiscal year and repealed a requirement that the U.S. Comptroller General conduct, audit, and report to the Congress regarding the National Foundation for Biomedical Research. (P.L. 104-316)
September 30, 1996—The FY 1997 Labor, HHS, and Education Appropriations Act continued the prohibition on use of NIH funds for human embryo research. The act provided for construction of the new Mark O. Hatfield Clinical Research Center. (P.L. 104-208)
July 3, 1997—Section 2118 of the Energy Policy Act of 1992 was amended to extend the Electric and Magnetic Fields Research and Public Information Dissemination Program, a joint U.S. Department of Energy and NIEHS venture, for 1 year. (P.L. 105-23)
August 5, 1997—The Balanced Budget Act authorized a $150 million increase for research on the prevention and care of type-1 diabetes. (P.L.105-33)
November 21, 1997—The Food and Drug Administration Regulatory Modernization Act of 1997 directed NIH, in coordination with the CDC, to develop and maintain a database and information service that provides centralized information on research, treatment, detection, and prevention activities related to serious or life-threatening diseases. The act also directed NIH, the FDA, and medical and scientific societies to identify published and unpublished studies by clinicians and researchers that may support a supplemental application for a licensed product and to encourage manufacturers to submit a supplemental application or to conduct further research to support a supplemental application. (P.L. 105-115)
December 2, 1997—The Small Business Reauthorization Act, reauthorized the Small Business Technology Transfer (STTR) program for 4 years and required that the STTR program information be submitted as a part of Federal agency performance plans and be made available to the Congress. (P.L. 105-135)
December 17, 1997—The Federal Advisory Committee Act Amendment included provisions that permit the public to attend taxpayer-funded advisory committee meetings and receive minutes and other documents prepared for or by such committees. (P.L. 105-153)
June 23, 1998—The Agricultural Research, Extension, and Education Reform Act of 1998 required the Secretary, U.S. Department of Agriculture, to establish a Food Safety Research Information Office whose activities are carried out in cooperation with the NIH, the FDA, CDC, and public and private institutions. (P.L. 105-185)
July 16, 1998—The National Marrow Donor Program was reauthorized. (P.L. 105-196)
August 7, 1998—The Workforce Investment Partnership Act of 1997 is omnibus legislation that created in statute an Interagency Committee on Disability Research whose membership includes the directors of NIH and NIMH. (P.L. 105-220)
October 9, 1998—The Mammography Quality Standards Reauthorization Act reauthorized through FY 2002 such sums as may be necessary for the award of grants for breast cancer screening surveillance research. (P.L. 105-248)
October 19, 1998—The Federal Employees Health Care Protection Act of 1998 contained a provision to raise the cap from $20,000 to $30,000 for the Physician's Comparability Allowance (PCA). The PCA is subject to "applicable limitations," including aggregate compensation limitation. (P.L. 105-266)
October 21, 1998—The Appropriations for the Department of Veterans Affairs and Housing and Urban Development for FY 1999 provided appropriations for the NIEHS Superfund Worker Training Program and for the NIEHS Superfund Research Program. (P.L. 105-276)
October 21, 1998—FY 1999 Treasury and General Government Appropriations prohibited interagency financing of commissions, councils, committees, or similar groups. Section 622 prohibited Federal agencies from purchasing information technology that is not Year 2000 compliant unless the agency's chief information officer determines that noncompliance would be necessary to the function and operation of the agency.
October 21, 1998—The Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999, created in statute at NIH the National Center for Complementary and Alternative Medicine; renamed the NIDR as the National Institute of Dental and Craniofacial Research; and named two new NIH buildings after retiring members of Congress: 1) the Louis Stokes Laboratories and 2) the Dale and Betty Bumpers Vaccine Research Facility.
The act continued human embryo research prohibition, the NIH director's transfer authorities, and third-party payment authority for the NIH Clinical Center. In addition, permanent authority was provided to NIH for transit subsidies for non-full-time equivalent bearing positions, including visiting fellows, trainees, and volunteers. General provisions were provided for prohibition on the use of funds for programs for sterile needle distribution; and a prohibition on the use of funds for promoting legalization of controlled substances, except where there is evidence of therapeutic advantage or that federally sponsored clinical trials are being conducted to determine advantage.
This act authorized NICHD to be represented on a peer review panel established by the Secretary of Education to review applications from the states for scientifically based reading research activities.
Provisions included amendment of OMB Circular A-110, requiring Federal funding agencies to ensure that all data produced under an award will be made available to the public through the procedures established under the Freedom of Information Act.
The director of the Office of National Drug Control Policy was directed to consult with the directors of appropriate NIH institutes to establish criteria for evaluation of substance abuse treatment and prevention programs.
The conference report included the following:
- Directive language for the NCI on prostate cancer research.
- The NIDDK and other ICs were urged to expand funding for juvenile diabetes.
- The NIEHS and ORMH would enhance support for environmental health effects/minority health centers; NIEHS is to work with NIOSH on the national occupational research agenda (NORA).
- NIA is to launch a full-scale prevention initiative for Alzheimer's disease and is to work with NIOSH on NORA.
- The NIAMS is to expand research on Osteogenesis Imperfecta.
- The Office of Rare Diseases is to develop an information program on biological samples and human cell and tissue banks available for research purposes.
- The Office of Behavioral and Social Sciences Research is urged to establish two to five mind/body centers.
- NIH is to focus resources on the cause and treatment for Parkinson's disease.
- NIH is to enhance research on Multiple Sclerosis and other autoimmune disorders. (P.L. 105-78)
October 28, 1998—The Next Generation Internet Research Act of 1998 amended the High-Performance Computing Act of 1991 to authorize Government-funded research into high-capacity, high-speed computer networks. (P.L. 105-305)
October 31, 1998—The Women's Health Research and Prevention Amendments of 1998 extended and/or amended various NIH authorities related to women's health research, including: the drug DES (diethylstilbestrol); osteoporosis, Paget's disease and related disorders; breast, ovarian and related cancers; heart attack, stroke, and other cardiovascular diseases; aging processes; and the Office of Research on Women's Health. (P.L. 105-340)
November 10, 1998—The Federal Reports Elimination Act of 1998 provided for the elimination of the following reports of particular interest to NIH: Report of the Council on Alzheimer's Disease; Report on the U.S.-Japan Cooperative Medical Science Program; Report of the Interagency Coordinating Committee on Arthritis and Musculoskeletal and Skin Diseases; Report on Family Planning and Population Research; Report of the NICHD Associate Director for Prevention; Report on Health Services Research; Annual Reports of the National Diabetes Advisory Board, National Digestive Diseases Advisory Board, and National Kidney and Urologic Diseases Advisory Board; Public Health Service Report; Annual Report on Disease Prevention; and Annual Report on Administrative Expenses. (P.L. 105-362)
November 13, 1998—The Health Professions Education Partnership Act reauthorized and consolidated health professions, nursing, and minority and disadvantaged health education programs within the Department of Health and Human Services. The act provided additional research training and Title 38 appointment authorities for the NIH director; reauthorized the NIH AIDS loan repayment program (LRP); and increased the maximum annual loan repayment from $20,000 to $35,000 for this and other NIH LRPs; authorized tax relief benefits for participants in the NIH Clinical Researchers from Disadvantaged Backgrounds LRP; and made discretionary the National Center for Research Resources director's authority for construction awards to the regional primate research centers and reduced the amount that may be reserved from $5.0 million to $2.5 million. (P.L. 105-392)
November 20, 1999—Federal Financial Assistance Management Improvement Act of 1999 required agencies to develop plans to streamline grant administration activities. OMB was directed to 1) develop a common application, or set of common applications, for applying for Federal assistance; 2) develop a common system, including electronic processes, for grant administration activities; and 3) develop uniform administrative rules for Federal financial assistance programs across different agencies. (P.L. 106-107)
November 29, 1999—Omnibus Appropriations for NIH, Fiscal Year 2000, provided NIH with an increase of $2.3 billion over FY 1999. This legislation also included the Newborn and Infant Screening and Intervention Act which directed the National Institute on Deafness and Other Communication Disorders (NIDCD) to carry out a program of research on the efficacy of new screening techniques and technology, including clinical trials of screening methods, studies on the efficacy of intervention, and related basic and applied research on hearing loss in newborns. (P.L. 106-113)
December 6, 1999—Healthcare Research and Quality Act reauthorized and renamed the Agency for Health Care Policy and Research as the Agency for Healthcare Research and Quality (AHRQ). Provisions required the AHRQ Director, to promote innovation in evidence-based clinical practice and healthcare technologies to consult with the NIH Director and work with the National Library of Medicine to develop an electronic clearinghouse of currently available assessments and those in progress. The NIH Director will serve on the AHRQ Advisory Council as an ex oficio member. (P.L. 106-129)
June 30, 2000—The Electronic Signatures in Global and National Commerce Act mandated that electronic contracts with electronic signatures have the same legal force as paper contracts. (P.L. 106-229).
July 10, 2000—The Radiation Exposure Compensation Act (RECA) Amendments of 2000 amended the Public Health Service Act to establish a grant program to States for education, prevention, and early detection of radiogenic cancers and diseases. Entities eligible to receive such grants include National Cancer Institute-designated cancer centers. The competitive grants would be made by the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, in consultation with the Directors of the National Institutes of Health and Indian Health Service. (P.L. 106-245)
July 13, 2000—The Emergency Supplemental Act, Fiscal Year 2000, repealed Section 216 of P.L. 106-113, the Omnibus Consolidated Appropriations Act, which funded the NIH for fiscal year (FY) 2000. Section 216 of that Act specified that $3 billion of the funds appropriated for NIH were not available for obligation until September 29, 2000, and would not be available for obligation until October 15, 2000. This provision was repealed, thus releasing the funds for use prior to September 29, 2000. (P.L. 106-246)
July 28, 2000—The Semipostal Authorization Act amended the Postal Service Reorganization Act to extend the authority to issue semipostal stamps for breast cancer research until July 29, 2002. Seventy percent of the profits of this stamp go to the NIH to fund breast cancer research and thirty percent go to the U.S. Department of Defense for its breast cancer research program. Appropriations to NIH was not affected by any proceeds received from the sale of semipostal stamps. (P.L. 106-253)
October 17, 2000—The Children's Health Act of 2000 authorized Federal programs for research and other activities related to autism, Fragile X, juvenile arthritis, juvenile diabetes, asthma, hearing loss, epilepsy, traumatic brain injuries, childhood skeletal malignancies, muscular dystrophy, autoimmune diseases, birth defects and genetic mental impairment, among other conditions. The bill also required an NIH pediatric research initiative within the Office of the Director, NIH, with provisions addressing loan repayment for pediatric researchers and pediatric research human subject protections. (P.L. 106-310)
October 17, 2000—The American Competitiveness in the 21st Century Act of 2000 increased the cap on the number of H1-B visas from 115,000 to 195,000 each year for the next 3 years. The legislation eliminated the cap on H1-B visas for government, academic, non-profit and affiliated workers. (P.L. 106-313)
October 20, 2000—The Ryan White CARE Act Amendments of 2000 provisions required an NIH review of the distribution and availability of ongoing and appropriate HIV/AIDS research projects to existing Ryan White sites for the purpose of enhancing and expanding voluntary access to HIV-related research, particularly in communities underserved by such projects. In addition, the NIH is required to conduct research on development of rapid diagnostic test kits. (P.L. 106-345)
November 1, 2000—The Technology Transfer Commercialization Act of 1999 is intended to "improve the ability of Federal agencies to license Federally-owned inventions." (P.L. 106-404)
November 6, 2000—The Needlestick Safety and Prevention Act required changes in the blood-borne pathogens standards in effect under the Occupational Safety and Health Act of 1970 to protect workers whose occupations expose them to pathogens such as HIV. Employers are required to use needles and other medical devices that have built-in safety mechanisms to reduce accidental punctures and to keep a log of needlestick injuries that would protect confidentiality of injured employees. (P.L. 106-430)
November 13, 2000—The Older Americans Act of 2000 required a White House Conference on Aging to be convened no later than December 31, 2005, to make fundamental policy recommendations regarding programs that are important to older individuals, and to the families and communities of such individuals. The Conference is to be planned and conducted under the direction of the Secretary, in cooperation with other federal agencies, including the Director of the National Institute on Aging. H.R. 782 will now proceed to the Senate for consideration. The legislation reauthorizes and amends the Older American's Act of 1965 and the Older Americans Act Amendments of 1987. (P.L. 106-501)
November 13, 2000—The Public Health Improvement Act of 2000 is a compilation of bills which amended the Public Health Service Act and provided new authorities to NIH and other Public Health Service agencies, or placed in statute ongoing activities or programs. This law provided the following: 1) established in statute the National Center for Research Resources (NCRR's) general clinical research centers, the NIH Career Awards in Patient-Oriented Research, which include the Mentored Patient-Oriented Research Career Development Award (K23), the Mid-Career Investigator Award in Patient-Oriented Research (K24), and the Clinical Research Curriculum Award (K30); 2) required the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) to expand and intensify research and related activities regarding lupus; 3) substantially increased the authorization for NIH extramural facilities construction and authorized $100 million to allow the continued operation of NCRR's Shared Instrumentation Grant Program; 4) established in statute an extramural clinical loan repayment program for qualified health professionals who agree to conduct clinical research; 5) created in statute the Alzheimer's Disease Clinical Research and Training program within the National Institute on Aging (NIA); 6) extended the current authority to conduct basic and clinical research in combating prostate cancer research at the National Cancer Institute; 7) directed NIH to evaluate the effectiveness of screening strategies; and 8) included a technical amendment to the Children's Health Act of 2000 (Public Law 106-310) which corrects an inaccurate citation to a provision in the Code of Federal Regulations. (P.L. 106-505)
November 22, 2000—The Minority Health and Health Disparities Research and Education Act of 2000 created in statute a National Center on Minority Health and Health Disparities at the NIH to coordinate: 1) health disparities research performed or supported by NIH, 2) a grant program through the new Center to further biomedical and behavioral research education and training, 3) an endowment program to facilitate minority and other health disparities research at centers of excellence, and 4) a loan repayment program to train members of minority or other health disparities populations as biomedical research professionals. (P.L. 106-525)
December 19, 2000—The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Authorization Act of 2000 codifies the existing ICCVAM as a permanent standing committee to be administered by the National Institute on Environmental Health Sciences. The statute requires the ICCVAM to establish, wherever feasible, guidelines, recommendations, and regulations that promote the regulatory acceptance of new or revised scientifically valid toxicological tests that protect human and animal health and the environment while reducing animal tests and ensuring human safety and product effectiveness. (P.L. 106-545)
December 20, 2000—The Chimpanzee Health Improvement, Maintenance, and Protection Act requires NIH to enter into a contract with a nonprofit private entity for the purpose of operating a sanctuary system for the long-term care of chimpanzees that are no longer needed in research conducted or supported by the NIH, the Food and Drug Administration, and other Federal agencies. The law provides for standards for permanent retirement of chimpanzees into the system, including prohibiting using sanctuary chimpanzees for research except in specified circumstances. (P.L. 106-551)
December 21, 2000—The Consolidated Appropriations Act, 2001, provides funding for the U.S. Departments of Labor, Health and Human Services (HHS) and Education; the legislative branch; and the Treasury and Postal Service, and H.R. 5667, the Small Business Reauthorization Act. For the NIH this law provides an appropriation of a $2.523 billion, or 14 percent increase over fiscal year 2000. Specific provisions of the law: 1) provides $47.3 million within Buildings and Facilities for the National Neuroscience Research Center, to be named the John Edward Porter Neurosciences Research Center; 2) permits the Director of NIH to enter into and administer a longterm lease for facilities for the purpose of providing laboratory, office and other space for biomedical and behavioral research at the Bayview Campus in Baltimore, Maryland; 3) expands the intramural loan repayment program for clinical researchers from disadvantaged backgrounds to the extramural community; and 4) raises the salary cap for extramural investigators to Executive Level I from Level II. (P.L. 106-554)
December 28, 2000—The Federal Physicians Comparability Allowance Amendments of 2000 makes physician comparability allowances a permanent authority and requires the allowances to be treated as part of basic pay for retirement purposes. (P.L. 106-571)
December 29, 2000—The National Institute of Biomedical Imaging and Bioengineering Establishment Act amends the Public Health Service Act to create at NIH the National Institute of Biomedical Imaging and Bioengineering. The statute authorizes an amount equal to (plus inflation) the amount currently spent by NIH Institutes for imaging and engineering programs. In establishing the Institute, the Director of NIH is authorized to transfer personnel, use appropriate facilities to house the new Institute, and obtain administrative support from other agencies of NIH. The Institute is required to have a 12-member advisory council, and prepare a plan to address the consolidation and coordination of NIH biomedical imaging and engineering programs, as well as related activities of other Federal agencies. (P.L. 106-580)
May 24, 2001—The Animal Disease Risk Assessment, Prevention and Control Act of 2001 mandates that the Secretary of Agriculture submit a final report to Congress on plans by Federal agencies (including the National Institutes of Health and the Agriculture Research Service and Cooperative State Research, Education, and Extension Service of the U.S. Department of Agriculture) to carry out in partnership with the private sector 1) research programs into the causes and mechanisms of transmission of foot and mouth disease and bovine spongiform encephalopathy (BSE), variant Creutzfeldt-Jacob disease, and related disease, and 2) diagnostic tools and preventive and therapeutic agents needed for foot and mouth disease, BSE, variant Creutzfeldt-Jacob disease, and related diseases. In addition, this legislation mandates that the final report to Congress contain plans by Federal agencies (including the Centers for Disease Control and Prevention) 1) to monitor the incidence and prevalence of the transmission of foot and mouth disease, BSE, variant Creutzfeldt-Jacob disease, and related diseases in the United States; and 2) to assess the effectiveness of efforts to prevent and control the spread of foot and mouth disease, BSE, variant Creutzfeldt-Jacob disease, and related diseases in the United States. (P.L. 107-9)
July 24, 2001—The 2001 Supplemental Appropriations Act included 1) provisions to permit the transfer of funds from the National Library of Medicine (NLM) to the National Institutes of Health (NIH) Buildings and Facilities account to complete the design phase of a new NLM facility, 2) report language to permit the new National Institute of Biomedical Imaging and Bioengineering (NIBIB) to use funds appropriated to the NIH Office of the Director (OD) for start up of the new Institute, and 3) language directing that information requested from the Committee on Appropriations was to be transmitted "uncensored and without delay." (P.L. 107-20)
October 26, 2001—The Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (PATRIOT) Act of 2001 amends a number of titles of the United States Code in an effort to expand the Nation's ability to intercept and thwart terrorist threats. Of particular interest are amendments to Title 18 regarding possession, use, and transport of biological agents. These amendments seek to ensure that only those persons who have a lawful purpose for possessing, using, and/or transporting such agents are permitted to work with these agents, and that penalties are established for certain "restricted" individuals who are in possession of such agents. The Act also enhances the powers of the Attorney General, law enforcement officials, and the courts regarding wire, oral, and electronic communications. (P.L. 107-56)
December 18, 2001—The Muscular Dystrophy Community Assistance Research and Education Amendments of 2001 (MD-CARE Act) amends the Public Health Service Act. Of particular interest to NIH this legislation mandates that the Director of the National Institutes of Health, in coordination with the Directors of the National Institute of Neurological Disorders and Stroke, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Child Health and Human Development, and other national research institutes, as appropriate, expand and intensify programs with respect to research and related activities concerning Duchenne, myotonic, facioscapulohumeral, and other forms of muscular dystrophy (MD). In addition, the legislation 1) requires the establishment of Muscular Dystrophy Centers of Excellence, 2) requires the Secretary of Health and Human Services (HHS) to contract with the Institute of Medicine to study centers at NIH and make recommendations when their establishment is appropriate, 3) creates a Muscular Dystrophy Interagency Coordinating Committee that is required to develop a plan for conducting and supporting research and education on MD through the national research institutes and submits a biennial report to Congress describing research activities; 4) establishes a program in which samples of tissues and genetic materials that are of use in research on MD are donated, collected, preserved, and made available for such research; 5) requires the Secretary of HHS to provide a means of public input on existing and planned MD research activities; 6) requires the Centers for Disease Control and Prevention to carry out activities with respect to Duchenne MD epidemiology. (P.L. 107-84)
January 4, 2002—The Best Pharmaceuticals for Children Act reauthorizes the pediatric studies provision of the Food and Drug Administration Modernization and Accountability Act of 1997 to improve the safety and efficacy of pharmaceuticals for children. It continues to encourage pharmaceutical companies to conduct pediatric studies of on-patent drugs that are used in pediatric populations, but are not labeled for such use, by extending their market exclusivity. In addition, this legislation authorizes studies for "off-patent" drugs by the Federal Government or other entities with the expertise to conduct pediatric clinical trials. (P.L. 107-109)
January 10, 2002—The Department of Defense Appropriations Act, 2002 provides funding for NIH for bioterrorism under the Emergency Supplemental Act, 2002 (which is part of this legislation). The "conferees encourage the National Institute of Allergy and Infectious Diseases (NIAID) to conduct research on safer alternatives to the existing smallpox vaccine, such as an inactivated smallpox virus." In addition, funds are provided for the construction of a level-4 biosafety laboratory and related infrastructure costs at NIAID and for improving laboratory security at CDC and NIH. The bill also includes funds for the National Institute of Environmental Health Sciences (NIEHS) "for carrying out under current authorities, worker training, research, and education activities" in response to the September 11 terrorist attacks. (P.L. 107-117)
May 14, 2002—The Hematological Cancer Research Investment and Education Act, amends the Public Health Service Act to require 1) the Director of the National Institutes of Health, through the National Cancer Institute, to expand and coordinate blood cancer research programs, particularly with respect to leukemia, lymphoma, and multiple myeloma (the Joe Moakley Research Excellence Program); and 2) the Secretary of Health and Human Services to establish a related education program for patients and the general public (the Geraldine Ferraro Cancer Education Program). (P.L. 107-172)
June 12, 2002—The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 amends Section 319 of the Public Health Service Act to strengthen protections related to public health. The Act requires the Secretary of Health and Human Services (HHS), in coordination with appropriate Federal department and agency officials, to establish a joint interdepartmental working group on preparedness for acts of bioterrorism. Among its activities, this group is charged with providing consultations on, assistance in, and recommendations regarding provision of appropriate safety and health training; coordination and prioritization of countermeasures to treat, prevent, or identify exposures to biological agents; and research on pathogens likely to be used in a biological threat or attack on the civilian population. (P.L. 107-188)
August 2, 2002—The Supplemental Appropriations for FY 2002 bill names in statute the National Research Service Awards (NRSA) the Ruth L. Kirschstein National Research Service Awards. (P.L. 107-206)
October 26, 2002—The Medical Device User Fee and Modernization Act of 2002 amends Section 215 of the Public Health Service Act to authorize the Director of NIH to conduct or support research to examine the long-term health implications of gel and saline-filled breast implants. This authorization includes studies to 1) develop and examine techniques to measure concentrations of silicone in body fluids and tissues, and 2) track silicone breast implant recipients. Within 6 months of enactment, the Director of NIH is required to submit a report to Congress describing the status of research on breast implants being conducted or supported by the Agency. (P.L. 107-250)
October 26, 2002—The Health Care Safety Net Amendments, repeals the requirement for the Health Resources and Services Administration loan repayment program (LRP) reporting requirements, which also repeals the National Institutes of Health LRP reporting requirements, which were mandated under the National Health Service (NHS) authorities. Specifically, this repeals Section 338B(i) of the Public Health Service Act, which required an annual report to Congress on the NHS Corps Loan Repayment Program. (P.L. 107-251)
November 2, 2002—The 21st Century Department of Justice Appropriations Authorization Act contains a provision that amends Section 464N of the Public Health Service Act addressing drug abuse and addiction research. The law provides that the Director of NIDA may make grants or enter into cooperative agreements to expand the current and ongoing interdisciplinary research and clinical trials with treatment centers of the National Drug Abuse Treatment Clinical Trials Network that relate to drug abuse and addiction, including related biomedical, behavioral, and social issues. The law mandates that the Director of NIDA shall promptly disseminate research results to Federal, State, and local entities involved in combating drug abuse and addiction. The law also requires NIDA to conduct a study of methamphetamine treatment. (P.L. 107-273)
November 6, 2002—The Rare Diseases Act provides statutory authorization for the existing NIH Office of Rare Diseases (ORD). The measure requires the Director of the Office of Rare Diseases to recommend an agenda for research on rare diseases, promote coordination and cooperation among NIH Institutes and Centers, promote sufficient allocation of NIH resources related to rare diseases, promote the establishment of a centralized rare diseases information clearinghouse, prepare a biennial report of rare disease research activities and opportunities, prepare the annual report of the Director of NIH to Congress on rare disease research, and serve as the principal advisor on orphan diseases to the Director of NIH. In addition, the legislation establishes regional Centers of Excellence on Rare Diseases. (P.L. 107-280)
November 25, 2002—The Homeland Security Act of 2002 establishes a new Executive Branch agency known as the U.S. Department of Homeland Security (DHS). Among its research provisions, the Act: 1) establishes within DHS a Directorate of Science and Technology, to conduct basic and applied research, development, demonstration, testing, and evaluation activities that are relevant to any or all elements of DHS with the exception of human health-related research and development activities; 2) requires the Secretary of HHS to set priorities, goals, objectives, and policies and to develop a coordinated strategy for these activities in collaboration with the Secretary of Homeland Security; and 3) authorizes the Secretary of Homeland Security to draw upon the expertise of any Federally-supported laboratory, and to establish a headquarters laboratory and additional laboratory units for the Department at any laboratory or site. The Act also includes provisions regarding Federal agency information security protections; acquisitions and procurement improvements; permanent extension, revision, and expansion of authorities for use of voluntary separation incentive pay and voluntary early retirement; and other authorities relevant to human resources management. (P.L. 107-296)
December 18, 2002—The Public Health Service Amendment on Diabetes amends Section 319 of the Public Health Service Act to renew funding for the special diabetes programs for Type 1 diabetes research, and also the parallel services program for diabetes in Native Americans, at $150 million for each of the FYs 2004 through 2008. This measure provides additional funding separate from the regular appropriations process for the special diabetes programs for Type 1 diabetes research at NIH. (P.L. 107-360)
May 27, 2003—The United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 has the following provisions: 1) requires the President to establish a comprehensive, integrated 5-year strategy to combat global HIV/AIDS, including specific objectives, approaches and strategies; 2) assigns priorities for relevant executive branch agencies; 3) improves coordination among such agencies; and 4) projects general levels of resources needed to achieve the stated goals. This legislation also requires the President to establish a position of HIV/AIDS Response Coordinator at the U.S. Department of State, who would have primary responsibility for oversight and coordination of all U.S. international activities to combat the HIV/AIDS pandemic. (P.L. 108-25)
August 15, 2003—The Mosquito Abatement for Safety and Health Act authorizes grants through the Centers for Disease Control and Prevention for mosquito control programs to prevent mosquito-borne diseases. This legislation requires the Director of the National Institute of Environmental Health Sciences to conduct or support research on methods of controlling the population of insects and vermin that transmit dangerous, diseases to humans. (P.L. 108-75)
December 8, 2003 —The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 requires NIDDK to conduct a clinical investigation of pancreatic islet cell transplantation. (P.L. 108-173)
January 23, 2004 —The Omnibus Appropriations for FY 2004, contains the following two provisions: 1) provides flexible research authority for the NIH Director to enter into transactions (other than contracts, cooperative agreements, or grants) to carry out research in support of the NIH Roadmap Initiative of the Director on a pilot basis; and 2) designates the NIH Muscular Dystrophy Centers as the Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers. (P.L. 108-199)
July 21, 2004 —The Project Bioshield Act of 2004 authorizes NIAID to award grants or contracts to public and nonprofit private entities to expand, remodel, renovate, or alter existing research facilities or construct new research facilities. (P.L. 108-276)
August 2, 2004—The Minor Use and Minor Species Animal Health Act of 2004 requires NIH to convene an ad hoc panel of nationally known experts in the fields of allergy and immunology to review current basic and clinical research activities related to food allergies. The panel is to make recommendations to the Secretary regarding the enhancement and coordination of food allergies research not later than 1 year after the date of enactment of the Act. (P.L. 108-282)
October 25, 2004—The Pancreatic Islet Cell Transplantation Act of 2004 requires the Diabetes Mellitus Interagency Coordinating Committee to include in its annual report an assessment of the Federal activities and programs related to pancreatic islet cell transplantation, which shall address: 1) the adequacy of funding; 2) policies and regulations affecting the supply of pancreata; 3) the effect of xenotransplantation; 4) the effect of the United Network for Organ Sharing policies; 5) the existing mechanisms to collect and coordinate outcome data from trials; 6) implementation of multi-agency clinical investigations; and 7) recommendations for legislation and administrative actions to increase the supply of pancreata. (P.L. 108-362)
November 30, 2004—The Research Review Act of 2004 requires the NIH to submit an NIH Roadmap for Medical Research progress report to Congress no later than February 1, 2005. The bill also incorporated a component of an earlier bill, the Christopher Reeve Paralysis Act, requiring NIH to prepare a report describing NIH Roadmap efforts with respect to spinal cord injury and paralysis research. (P.L. 108-427)
December 8, 2004—The Consolidated Appropriations Act, 2005, provided that "The Center for Biodefense and Emerging Infectious Diseases (Building 33) at the National Institutes of Health is hereby named the C.W. Bill Young Center for Biodefense and Emerging Infectious Diseases." (P.L. 108-447)
November 11, 2005—The Breast Cancer Research Stamp Reauthorization Act reauthorized the issuance of semipostal stamps for breast cancer research, from which NIH receives seventy percent of the profits and the Department of Defense receives 30 percent for their respective breast cancer research activities. These funds are in addition to annual appropriations received. (P.L. 109-100)
December 5, 2005—The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2006, provided new language permitting the Office of AIDS Research to use its funding in this Act to make grants for the construction or renovation of facilities in order to expand a breeding colony that will serve as a new national resource to breed nonhuman primates for AIDS research; and a general provision stating that "None of the funds made available in this Act may be used to request that a candidate for appointment to a Federal scientific advisory committee disclose the political affiliation or voting history of the candidate or the position that the candidate holds with respect to political issues not directly related to and necessary for the work of the committee involved." These provisions carry a time limitation relevant to FY 2006 activities only. (P.L. 109-149)
December 19, 2006—The Combating Autism Act of 2006 requires the Director of the National Institutes of Health (NIH) to expand, intensify, and coordinate autism spectrum disorders (ASD)-related research. Specifically, the Act sets forth a nonexhaustive list of research areas to be included in NIH's ASD initiatives, including research into possible environmental causes of autism. It expands the scope of autism research under NIH and the Centers of Excellence in such research to address the entire scope of ASD, rather than only autism. The new law also authorizes the Director to consolidate program activities to improve efficiencies and outcomes. (P.L. 109-416)
December 20, 2006—The Sober Truth on Preventing Underage Drinking Act requires the Secretary of Health and Human Services to formally establish and enhance the efforts of the interagency coordinating committee that began operating in 2004, focusing on underage drinking. The Director of the National Institute on Alcohol Abuse and Alcoholism, and such other Federal officials as the Secretary of Health and Human Services determines to be appropriate will serve as members of this interagency coordinating committee. (P.L. 109-422)
January 15, 2007—The NIH Reform Act revises Title IV of the PHS Act and creates the Division of Program Coordination, Planning, and Strategic Initiatives, to be supported by a Common Fund. There is no growth formula for the Fund and a review is required when the Fund reaches five percent of the total NIH budget. In addition, provisions establish a Council of Councils to advise on research proposals that would be funded by the Common Fund; establish a Scientific Management Review Board (SMRB) to conduct periodic organizational reviews of NIH every seven years, and make recommendations on the use of NIH organizational authorities; and require a public process for reorganizing NIH programs. Provisions authorize (but do not appropriate) for NIH $30,331,309,000 for FY 2007, $32,831,309,000 for FY 2008 and such sums as may be necessary for FY 2009. Provisions also authorize the NIH Director to award grants for demonstration projects for research bridging the biological sciences with the physical, chemical, mathematical, and computational sciences; and authorize the establishment of demonstration programs that award grants, contracts, or engage in other transactions, for high-impact, cutting-edge research demonstration programs. (P.L. 109-482)
May 25, 2007—Supplemental Appropriations for FY 2007 (Rescission for NIH) transferred a total of $99 million from the FY 2007 NIH appropriation to the Assistant Secretary for Preparedness and Response for advanced development of medical biodefense countermeasures. This work is to be conducted by the Assistant Secretary, consistent with the authority provided in the “Pandemic and All-Hazards Preparedness Act.” The transfer consists of $49.5 million from NIAID and $49.5 million from the NIH Office of the Director. (P.L. 110-28)
September 27, 2007—The Food and Drug Administration Amendments Act of 2007, although primarily affecting authorities of the FDA, requires (1) NIH to identify a point of contact to help innovators and physicians identify sources of funding for the development of such devices; (2) the HHS Secretary, acting through FDA and NIH, to create a research plan to expand research on pediatric medical devices; (3) NIH to develop a list of those areas of medicine that require additional testing involving children; (4) NIH to conduct pediatric studies in cases in which a drug is no longer under patent or the manufacturer of a patented drug has declined to conduct a requested study and other funds are not available; and (5) NIH to expand ClinicalTrials.gov to include information on a broader scope of trials and ultimately to include certain information regarding the results of those trials. (P.L. 110-85)
December 13, 2007—The Breast Cancer Research Stamp Reauthorization Act reauthorizes the Breast Cancer Research stamp through December 31, 2011, and requires an annual report to Congress describing how the funds generated by the stamp are used. (P.L. 110-150)
December 26, 2007—The Consolidated Appropriations Act of 2008 provides in Division D $29.456 billion for NIH; this includes $150 million for Type 1 diabetes. The Act includes a transfer of $295 million within NIH for the Global AIDS Fund; $111 million for the National Children’s Study; $504,420,000 for the Common Fund; $96,030,090 for research on chemical, radiological and nuclear countermeasures; $10,000,000 for the Director's Discretionary Fund; and $25,000,000 for the flexible research authority. (P.L. 110-161)
December 29, 2007—The Medicare, Medicaid, and SCHIP Extension Act of 2007 includes a provision that amends Section 319 of the PHS Act to extend the funding for the special program for Type 1 diabetes at the current funding level of $150 million through FY 2011. This program, which was set to expire in FY 2008, provides additional funding for the special program for Type 1 diabetes research at NIH that is separate from the regular appropriations process. (P.L. 110-173)
April 28, 2008—Traumatic Brain Injury (TBI) Act of 2008 authorizes (1) funding for trauma-related research, treatment, surveillance, and education activities by CDC, HRSA, and NIH trauma research program and provided authorizations for FYs 2009–2012; (2) requires that CDC and NIH report to the relevant congressional committees on activities and procedures that can be implemented by CDC, the U.S. Department of Defense, and the U.S. Department of Veterans Affairs to improve the collection and dissemination of compatible epidemiological studies on the incidence and prevalence of TBI in the military and veterans populations. (P.L. 110-206)
June 30, 2008—The Supplemental Appropriations Act, 2008, provides $150 million for the NIH, which shall be transferred to its Institutes and Centers and to the Common Fund established under section 402A(c)(1) of the PHS Act in proportion to the appropriations otherwise made to such Institutes, Centers, and Common Fund for FY 2008; provisions also set forth the conditions under which these funds may be utilized. Although specific to the Department of Defense, provisions include $75,000,000 appropriated to the “Defense Health Program” for operation and maintenance for psychological health and TBI, to remain available until September 30, 2009. Note: Report language accompanying the Act explains that within that amount is $70,000,000 to increase investigators and research capabilities in TBI and regenerative medicine across the Armed Forces involving an intramural start-up for the study of blast injury to the brain and post traumatic stress by studying actual combat casualties cared for at Walter Reed Army Medical Center and the National Naval Medical Center and using sophisticated neuroimaging technology at the NIH Clinical Center. (P.L. 110-252)
July 29, 2008—The Carolyn Pryce Walker Conquer Childhood Cancer Act amends Title IV of the PHS Act to require the HHS secretary, in collaboration with the NIH director and other Federal agencies with an interest in the prevention and treatment of pediatric cancer, to continue to enhance, expand, and intensify pediatric cancer research. The Act authorizes the HHS secretary to award grants for public awareness of pediatric cancers and available treatments and research and requires the secretary, acting through the director of the CDC, to award a grant to enhance and expand the infrastructure to track the epidemiology of pediatric cancer into a comprehensive nationwide registry. (P.L. 110-285)
October 8, 2008—The Breast Cancer and the Environment Act requires the HHS secretary to establish an Interagency Breast Cancer and Environmental Research Coordinating Committee on which representatives from 7 Federal agencies will serve, including the NIH, as well as 12 additional non-Federal members. The Interagency Breast Cancer and Environmental Research Coordinating Committee will share and coordinate information on existing research activities and make recommendations to NIH and other Federal agencies regarding improving existing research programs related to breast cancer research; develop a comprehensive strategy; and advise NIH and other Federal agencies in the solicitation of proposals for collaborative, multidisciplinary research. (P.L. 110-354)
October 8, 2008—The Paul D. Wellstone Muscular Dystrophy Community Assistance, Research, and Education Amendments Act, 2008, creates in statute the Muscular Dystrophy Centers of Excellence as the Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers; names NHLBI as a member of the Muscular Dystrophy Coordinating Committee (MDCC); and authorizes MDCC to give special consideration to enhancing the clinical research infrastructure to test emerging therapies for the various forms of muscular dystrophy. (P.L. 110-361)
October 8, 2008—The Prenatally and Postnatally Diagnosed Conditions Awareness Act provides that the HHS secretary may, acting through the director of NIH, the director of CDC, or administrator of HRSA, oversee activities such as the awarding of grants and contracts in order to accomplish the goals of providing information and coordination of available support networks to parents of children diagnosed with Down syndrome or other prenatally or postnatally diagnosed conditions. Grant awardees are required to provide “up to date, evidence based, written information concerning the range of outcomes for individuals living with the diagnosed condition, including physical, developmental, educational, and psychosocial outcomes.” (P.L. 110-374)
October 13, 2008—The Comprehensive Tuberculosis Elimination Act of 2008 amends the PHS Act to authorize the NIH director to expand, intensify, and coordinate tuberculosis research and development and related activities of the national research institutes with the goal of eliminating the disease. These activities may include enhancing basic and clinical research on TB, including drug-resistant TB; expanding research on the relationship between TB and HIV; and developing new tools for the elimination of TB, including public health interventions and methods to enhance the detection of and responses to outbreaks of TB and its drug-resistant forms. (P.L. 110-392)
February 17, 2009—The American Recovery and Reinvestment Act of 2009 included $10 billion for NIH, which is available until September 30, 2010 (plus $400 million from AHRQ. Funds for NIH were specified as follows:
$1.3 billion for NCRR, of which $1 billion is for competitive awards for the construction and renovation of extramural research facilities and $300 million for the acquisition of shared instrumentation and other capital research equipment.
$8.2 billion for the NIH Office of the Director, of which $7.4 billion is designated for transfer to Institutes and Centers and to the Common Fund, with the remaining $800 million to be retained in the OD to be used for purposes that can be completed within 2 years; priority is to be placed on short-term grants that focus on specific scientific challenges, new research that expands the scope of ongoing projects, and research on public and international health priorities. Bill language is included to permit the NIH director to use $400 million for the flexible research authority authorized in section 215 of Division G of P .L. 110-161. The funds available to NIH can be used to enhance central research support activities. Bill language also indicates that the funds provided in this Act to NIH are not subject to Small Business Innovation Research (SBIR) and Small Business Technology Transfer (SBTT) set-aside requirements.
$500 million for NIH Buildings and Facilities, for construction as well as renovation.
For purposes of this stimulus funding, there are some requirements regarding “Buy American” pertaining to American iron, steel and manufactured goods. (P.L. 111-5)
March 11, 2009—The FY 2009 Omnibus Appropriations Act includes $30.3 billion for the 26 accounts that comprise the NIH total appropriation; continues the allocation to NIH of $8,200,000 in program evaluation set-aside funding, consistent with the budget request; transfers $1,000,000 from the Office of the Secretary to be provided to NIMH for the Interagency Autism Coordinating Committee; modifies a general provision requiring NIH-funded authors to deposit final manuscripts in the NLM’s PubMed Central by making the provision permanent; and includes a general provision requiring the HHS secretary to issue an advanced notice of proposed rulemaking regarding conflicts of interest among extramural NIH investigators.
The Interior portion of the law includes $78 million for NIEHS worker training and research programs. The Financial Services and General Government portion contains a moratorium on A-76 studies and competitions for FY 2009. (P.L. 111-8)
March 30, 2009—Omnibus Public Land Management Act of 2009 included provisions of the Christopher and Dana Reeve Paralysis Act, which authorized NIH to develop mechanisms to coordinate the paralysis research and rehabilitation activities of its Institutes and Centers in order to further advance such activities and avoid duplication; establish research consortia, to be designated the Christopher and Dana Reeve Paralysis Research Consortium; and the NIH director to award grants for multicenter networks of clinical sites that will collaborate to design clinical rehabilitation intervention protocols and measures of outcomes on different forms of paralysis. (P.L. 111-11)
September 30, 2009—The Small Business Act and Small Business Investment Act of 1958, Extension, provided a 1-month temporary extension of programs authorized under the 2 Acts, including the SBIR and STRR programs of NIH, through October 30, 2009. (P.L. 111-66)
October 28, 2009—The National Defense Authorization Act for FY 2010 required the Department of Defense “to provide” for chiropractic clinical trials to be conducted by NIH or an independent academic institution. (P.L. 111-84)
October 30, 2009—The Small Business Act and Small Business Investment Act of 1958, Extension, provided a 1-month temporary extension of programs authorized under the 2 Acts, including the SBIR and STTR programs of NIH through January 31, 2010. (P.L. 111-89)
December 16, 2009—The Consolidated Appropriations Act, 2010, provides $31 billion for NIH. Provisions of note in Section IV (Labor, HHS, and Education include the following:
Provides up to $193.8 million for continuation of the National Children's Study.Changes the current needle or syringe exchange prohibition such that the use of funds to distribute any needle or syringe to prevent the spread of blood-borne pathogens would be prohibited in areas that local public health or law enforcement agencies determine to be inappropriate—thus allowing the use of funds in areas that are deemed appropriate. Continues provisions that bar the use of funds for the creation of human embryos for research or research in which embryos are destroyed. (P.L. 111-117)
January 29, 2010—A bill to provide for an additional temporary extension of programs under the Small Business Act and the Small Business Investment Act of 1958. Extends the SBIR and STTR programs through April 30, 2010. (P.L. 111-136).
March 23, 2010—The Patient Protection and Affordable Care Act establishes the Cures Acceleration Network within the Office of the NIH director, names the NIH director (or his designee) as a member of the Patient-Centered Outcomes Research Institute (comparative effectiveness research) Board of Governors, and re-designates the National Center for Minority Health and Health Disparities as an institute. In addition, the Act requires the HHS secretary to contract with the Institute of Medicine to hold a conference on pain and to establish an Interagency Pain Research Coordinating Committee; the Secretary delegated these responsibilities to NIH. The Cures Acceleration Network provides 2 unique authorities: the ability to use “other transactions authority” and the authority to require matching funds from funding recipients. (P.L. 111-148)
April 30, 2010—A bill to provide for an additional temporary extension of programs under the Small Business Act and the Small Business Investment Act of 1958. Extends the SBIR and STTR programs through July 31, 2010. (P.L. 111-162)
July 30, 2010—A bill to provide for an additional temporary extension of programs under the Small Business Act and the Small Business Investment Act of 1958. Extends the SBIR and STTR programs through September 30, 2010. (P.L. 111-214)
September 30, 2010—A bill to provide for an additional temporary extension of programs under the Small Business Act and the Small Business Investment Act of 1958. Extends the SBIR and STTR programs through January 31, 2011. (P.L. 111-251)
December 15, 2010—The Medicare and Medicaid Extenders Act extended funding for the special diabetes program for type 1 diabetes under section 330B(b)(2)(c) of the Public Health Service Act through FY 2013 at $150 million. (P.L. 111-309)
December 18, 2010—The Charles "Pete" Conrad Astronomy Awards Act re-codifies the following existing law to a new Title 51, USC: The bill requires NASA and NIH to establish a working group to coordinate biomedical research activities in areas where microgravity environment may contribute to significant progress in the understanding and treatment of diseases and other medical conditions; requires NASA and NIH to establish a joint biomedical research grant program; and requires NASA and NIH to establish a joint graduate research fellowship program. (P.L. 111-314)
December 22, 2010—The Early Hearing Detection and Intervention Act reauthorizes, through FY 2015, section 399M(b)(2) of the Public Health Service Act, which requires the National Institute on Deafness and Other Communication Disorders to “continue a program of research and development on the efficacy of new screening techniques and technology, including clinical studies of screening methods, studies on efficacy of intervention, and related research.” (P.L. 111-337)
January 4, 2011—The America COMPETES Reauthorization Act, section 105 permits any agency head to “carry out a program to award prizes competitively to stimulate innovation that has the potential to advance the mission of the respective agency.” (P.L. 111-358)
January 31, 2011—A bill to provide for an additional temporary extension of programs under the Small Business Act and the Small Business Investment Act. Extends the SBIR/STTR program through May 31, 2011. (P.L. 112-1)
June 1, 2011—The Small Business Additional Temporary Extension Act extends the SBIR/STTR program through September 30, 2011. (P.L. 112-17)
September 30, 2011—The Combating Autism Reauthorization Act reauthorizes autism activities and the interagency autism coordinating committee through FY 2014. The Act requires a progress report due 2 years after enactment. (P.L. 112-32)
September 30, 2011—The Continuing Appropriations Act, 2012, extends the SBIR/STTR program through October 4, 2011. (P.L. 112-33)
October 5, 2011—The Continuing Appropriations Act, 2012, extends the SBIR/STTR program until November 18, 2011. (P.L. 112-36)
November 18, 2011—The Consolidated and Further Continuing Appropriations Act of 2012 extends the SBIR/STTR program until December 16, 2011. (P.L. 112-55)
December 16, 2011—A bill making further continuing appropriations for FY 2012 and for other purposes, extends the SBIR/STTR program until December 17, 2011. (P.L. 112-67)
December 17, 2011—A bill making further continuing appropriations for FY 2012 and for other purposes, extends the SBIR/STTR program until December 23, 2011. (P.L. 112-68)
December 23, 2011—The Consolidated Appropriations Act, FY 2012, includes funding for the Departments of Labor, Health and Human Services, and Education, and for NIH in the amount of $30.689 billion. This measure also creates the NIH National Center for Advancing Translational Sciences (NCATS) and abolishes the National Center for Research Resources (NCRR). The Cures Acceleration Network authority established in the Patient Protection and Affordable Care Act was relocated to the NCATS authority and several conforming changes were made. Several NCRR authorities were moved to other parts of the statute. (P.L. 112-74)
December 23, 2011——The Breast Cancer Stamp Reauthorization Act reauthorizes the breast cancer stamp through December 2015. Seventy percent of the proceeds from the stamp would be provided to NIH and the remainder to support breast cancer research funded by the Department of Defense. (P.L. 112-80)
December 31, 2011—The National Defense Authorization Act for FY 2012 reauthorizes the SBIR/STTR programs for 6 years and increases SBIR/STTR awards to $150,000 for phase I and $1 million for phase II awards. Provisions of particular interest to NIH would increase the SBIR set aside to 3.2% over 6 years and increase the STTR set aside to 0.45% over 6 years; allow small business concerns majority-owned and controlled by venture capital firms to be eligible for up to 25% of the SBIR funds; allow agencies to apply for waivers to exceed the hard cap on awards under the guidelines for phase I and phase II awards; and grant NIH a 1-year exception to the rule shortening the time span for final decisions to not more than 90 days after the date a solicitation closes. (P.L. 112-81)
July 9, 2012—The Food and Drug Administration Safety and Innovation Act reauthorizes user fees for the FDA. Directly related to NIH is a provision that reauthorizes section 409I(e)(1) of the PHS Act for the Program for Pediatric Studies of Drugs at $25 million for each of FYs 2013 to 2017. (P.L. 112-144)
January 2, 2013—The National Defense Authorization Act for FY 2013 includes the Recalcitrant Cancer Research Act, which requires the NCI director to develop scientific frameworks for the study of pancreatic cancer and lung cancer. NCI is authorized to develop additional frameworks. (P.L. 112-239)
January 2, 2013—The American Taxpayer Relief Act includes a provision to extend the special diabetes program for type 1 diabetes at its current rate of $150 million through 2014; delays the sequestration for 2 months; and reduces the total automatic cut for FY 2013. (P.L. 112-240)
March 26, 2013—The Consolidated and Further Continuing Appropriations Act of 2013 is an omnibus continuing resolution to fund the agencies of the federal government through September 30, 2013. The bill continues funding for the NIH under the same terms and conditions as for FY 2012 and includes the requirement for the sequester. For NIH, this is approximately 5%. The bill generally funds other government departments and agencies for FY 2013 at their FY 2012 enacted levels. Almost all FY 2013 funding provided by the measure subsequently would be reduced across the board as required by the sequestration ordered by the President on March 1; the Office of Management and Budget estimates that nondefense discretionary accounts subject to sequestration will be reduced by 5%. For NIH, the final bill includes an increase of about $70 million (before sequester), along with language requiring the director of NIH to contract with the Institute of Medicine to study the methodology underlying the National Children’s Study. The bill continues the federal employee pay freeze through the remainder of calendar year 2013. It also provides government-wide restriction on conferences: “None of the funds made available in this or any other appropriations Act may be used for travel and conference activities that are not in compliance with Office of Management and Budget Memorandum M-12-12 dated May 11, 2012.” The NIH program level after sequester is $29,151,462,000.
For more information on legislation affecting NIH, go to http://olpa.od.nih.gov.