FDA Revitalization Act

Summary

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: Negligible Risk - Specifies that no food additive shall be deemed to be safe if as a whole (current law does not require that food or color additives, or animal drugs, be considered as a whole) it is found to induce cancer when ingested by man or animal or, after tests that are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal. (Current law contains an exception with respect to the use of a substance as an ingredient of food for animals raised for food production under certain conditions.) Waives the provision if the Secretary, on the basis of a petition containing scientifically adequate evidence with respect to the additive's mechanism of action, the manner in which it is metabolized, or other adequate evidence (including the use of risk assessment procedures, when appropriate), determines that the risk of cancer to humans from exposure under the intended conditions of use is negligible. Directs the Secretary to issue an order refusing an application for a drug which as a whole is found to induce cancer when ingested by man or animal or, after tests that are appropriate for the evaluation of the safety of animal drugs, to induce cancer in man or animal, unless the Secretary (applying the same criteria) determines that the risk of cancer to humans from exposure under the intended conditions of use in negligible. Specifies that a color additive shall be deemed unsafe, and shall not be listed, for use which: (1) will or may result in ingestion of all or part of such additive if the additive as a whole is found to induce cancer when ingested by man or animal or, after tests that are appropriate for the evaluation of the safety of color additives, is found to induce cancer in man or animal; or (2) will not result in ingestion of any part of such additive if, after the appropriate safety tests, or after other relevant exposure of man or animal to such additive, the additive as a whole is found to induce cancer in man or animal. Makes an exception where the Secretary (applying the same criteria) determines that the risk of cancer to humans from exposure under the intended conditions of use is negligible. Title VII: Uniformity in Regulation - Expresses the intent of the Congress to require national uniformity in all aspects of the regulation of food for human use, drugs, devices, and cosmetics in order to: (1) prevent interference with the objectives and purposes of Federal regulations; (2) assure the primary jurisdiction of the FDA in protecting the public health; and (3) permit national marketing of such articles without jurisdictional barriers. Prohibits any State or political subdivision from establishing or continuing in effect any requirement relating to the regulation of a food for human use, drug, device, or cosmetic unless such a requirement is also established pursuant to a statute for which responsibility for administration or implementation has been delegated by law or by the Secretary to the Commisssioner of Food and Drugs, and the State or local requirement is identical to the Federal requirement. Grants any State or political subdivision concurrent jurisdiction with the Secretary over the regulations of such items. Allows the Secretary, by regulation, after notice and opportunity for written and oral presentation of views, to exempt a proposed requirement relating to the regulation of such items if such requirement: (1) is justified by compelling and unique local conditions; or (2) protects an important and otherwise unprotected public interest, if certain conditions are met. Authorizes petitions to the Secretary for the adoption, by regulation, of an existing or proposed State or local requirement as a Federal requirement. Title VIII: 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 Commissioned 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 IX: 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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

No timeline events have been ingested for this record yet.

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

2 official files

• Reported to Senate with amendment(s)

  summary · EN · 21 October 1988

  Open at official source

• Introduced in Senate

  summary · EN · 6 June 1988

  Open at official source

Sponsors

No sponsors or actors listed by the source.

Related records

No cross-record relationships stored yet.