A bill to establish an office in the National Institutes of Health to assist in the development of drugs for diseases and conditions of low incidence.

Summary

Establishes within the National Institutes of Health the Office of Drugs of Limited Commercial Value under the direction of the Director of the National Institutes of Health. Establishes within the Office an advisory council to advise the Director and make recommendations to the Secretary of Health and Human Services respecting the time required for drug approval under the Federal Food, Drug, and Cosmetic Act. Authorizes the Director to provide financial assistance to entities for the development of drugs of limited commercial value, defined as a drug for a condition or disease of low incidence, to undertake the development of such drugs, undertake studies to determine the potential and need for specific drugs, and coordinate the efforts of public and private entities engaged in the development of such drugs. Requires the submission and approval of an application containing the scientific basis for the development and the proposed therapeutic use of the drug and other specified information before financial assistance is provided. Requires each entity receiving funds to keep specified records. Requires the Director to report to Congress within two years on the effectiveness of this Act.

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1 official file

• Introduced in Senate

  summary · EN · 17 July 1981

  Open at official source

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