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United States · Law · S

S. 845 (101st)

Food and Drug Administration Revitalization Act

enactedUnited States· United States Congress· EN

Introduced

19 April 1989

Last action

Status

Became Public Law No: 101-635.

Sponsors

Subjects

Discovery layer

Source updated

21 April 2025

Summary

FDA Revitalization Act - Title I: Power of FDA Over Real Property, Buildings, and Facilities - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to grant the Secretary of Health and Human Services 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 Scientific Health Service - Amends the Public Health Service Act to authorize the establishment of a Senior Scientific Health 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. Amends Federal law relating to physicians' comparability allowances to include any physician or dentist who is paid under provisions of this title. Title III: Recovery and Retention of Fees for FOIA Requests - Amends the FDCA to authorize the Secretary, through the Commissioner of Food and Drugs, to charge fees to recover direct and indirect costs incurred in processing Freedom of Information Act requests for records obtained or created under the Act. Title IV: Small Business Training and Technical Assistance - Amends the FDCA to authorize the Secretary, through the Commissioner, to establish an office to provide technical and other nonfinancial assistance to small manufacturers of medical devices, drugs, cosmetics, and foods to assist the manufacturers in complying with the Act. Authorizes appropriations for FY 1990 through 1992. Title V: Biotechnology Demonstration Project - Directs the Secretary to establish a demonstration project allowing the use of the facilities of any public or private cooperative with the permission of and in conjunction with the cooperative to promote the development of biotechnology. Authorizes appropriations for FY 1990 through 1992. Title VI: Training and Loan Repayment Programs - Authorizes grants to public or nonprofit academic institutions, including schools of medicine, dentistry, pharmacy, and food science, to enable such institutions to develop core curriculum programs to train individuals in the field of regulatory review. Requires obligated service of grantees as FDA employees. Authorizes appropriations for FY 1990 through 1992 for such grants. Directs the Secretary to establish a loan repayment program under which the Secretary must repay loans incurred by individuals to obtain training in regulatory review in exchange for the individuals serving a period of time as employees of the FDA. Directs the Secretary to: (1) issue regulations to carry out these provisions; and (2) carry out the program, to the extent practicable, in a manner that is consistent with the National Health Service Corps Loan Repayment Program. Authorizes appropriations for FY 1990 through 1992. 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. Title VIII: Human Food Safety, Technology, and Nutrition Advisory Committee - Directs the Secretary to establish the Human Food Safety, Technology, and Nutrition Advisory Committee to advise the Secretary and the Commissioner of Food and Drugs on issues involving food for human consumption, including: (1) food technology and production; (2) food research and development; (3) biotechnology and food products; (4) food safety; (5) the relationship between diet, nutrition, and health; and (6) health-related claims for food. Title IX: Automation of FDA - Directs the Secretary, through the Commissioner, to automate appropriate activities of the FDA to ensure timely review of activities regulated under the FDCA. Authorizes appropriations. Title X: Compensation and Employment Requirements for FDA and EPA Scientists - Requires the Director of the Office of Personnel Management to ensure, to the extent practicable, that the level of compensation and employment requirements are comparable for scientists employed by the FDA and by the Environmental Protection Agency. Title XI: Funding Floor for FDA - Declares that, notwithstanding any other provision of law, there shall be appropriated no less than a specified amount each fiscal year for the activities of the FDA.

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