legislation: 100-s-2468
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| 100-s-2468 | 100 | s | 2468 | FDA Revitalization Act | Health | 1988-06-06 | 1988-10-21 | Placed on Senate Legislative Calendar under General Orders. Calendar No. 1146. | Senate | Sen. Hatch, Orrin G. [R-UT] | UT | R | H000338 | 0 | (Reported to Senate from the Committee on Labor and Human Resources with amendment, S. Rept. 100-600) FDA Revitalization Act - Title I: Real Property - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to grant the Secretary of Health and Human Services (HHS) specified powers in connection with real property, buildings, and facilities (such as acquiring and disposing of property, leasing buildings, and accepting gifts) to facilitate the transaction of the business of the Food and Drug Administration (FDA). Title II: Senior Biomedical Scientific Service - Amends the Public Health Service Act to authorize the establishment of a Senior Biomedical Scientific Service, outside the competitive civil service, whose members may be appointed based solely on distinction and achievement in the fields of biomedical research or clinical research evaluation. Title III: Increased FTE Authority for Staff - Authorizes the Secretary of Health and Human Services to appoint and fix the compensation of not more than 350 additional employees for the FDA beyond the number assigned as of July 1, 1987. Title IV: Small Business Training and Technical Assistance - Amends the Medical Device Amendments of 1976 to authorize appropriations for FY 1989 through 1991 to the office within the Department of HHS which provides technical and other nonfinancial assistance to small manufacturers of medical devices to assist them in complying with the FDCA. Title V: Biotechnology - Directs the Secretary to establish a demonstration project allowing the use of the facilities of any public or private cooperative to perform activities authorized under the FDCA. Authorizes appropriations for FY 1989 through 1991. Title VI: Regulatory Review Medicine Training Grants - Authorizes grants to public or nonprofit academic institutions, including schools of medicine, dentistry, and pharmacy, to enable such institutions to develop core curriculum programs to train individuals in the field of regulatory review medicine. Requires obligated service of grantees as FDA employees. Authorizes appropriations for FY 1989 through 1991 for such grants. Directs the Secretary to establish a Science Training Grant Loan Repayment Program to assure an adequate supply of trained physicians, dentists, and pharmacists, veterinarians, and other health professionals. Gives priority to applications made by individuals: (1) whose training is in regulatory review medicine and in a health profession or specialty determined by the Secretary to be needed; and (2) who are committed to service with the FDA. Sets forth loan repayment terms and conditions. Directs the Secretary to submit to the Congress an annual report specifying: (1) the number and type of health profession training of individuals receiving loan payments under the Program; (2) the educational institution at which such individuals are receiving their training; (3) the number of applications filed; and (4) the amount of loan payments. Requires each individual who has entered into a written contract with the Secretary to provide service as a full-time employee of the FDA for the period of obligated service provided in such contract. Sets forth procedures for determining if the individual shall provide such service as a member of the Commissioner Corps of the PHS or as a civilian employee of the United States. Directs the Secretary, by regulation, to establish penalties applicable to an individual breaching the contract by failing to begin or complete the service obligation. Authorizes the Secretary to pay an individual who has entered into such an agreement an amount to cover all or part of the individual's expenses reasonably incurred in transporting himself, his family, and his possessions to the location of his duty station. Authorizes appropriations for FY 1989 through 1991. Title VII: Scientific Review Groups - Authorizes the Commissioner of Food and Drugs to establish such technical and scientific review groups as necessary to carry out the functions of the FDA, including functions under the FDCA. | 2025-04-21T12:24:17Z |