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United States · Bill · S

S. 1498 (97th)

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.

openUnited States· United States Congress· EN

Introduced

17 July 1981

Last action

29 July 1981 · Committee

Status

Committee on Labor and Human Resources requested executive comment from Health and Human Services Department; GAO; OMB.

Sponsors

Sen. Kassebaum, Nancy Landon [R-KS], Sen. Cochran, Thad [R-MS], Sen. Matsunaga, Spark M. [D-HI], Sen. Kasten, Robert W., Jr. [R-WI], Sen. Jackson, Henry M. [D-WA], Sen. Cohen, William S. [R-ME], Sen. Heinz, John [R-PA], Sen. Sarbanes, Paul S. [D-MD], Sen. Moynihan, Daniel Patrick [D-NY], Sen. Hatfield, Mark O. [R-OR], Sen. Stevens, Ted [R-AK], Sen. Williams, Harrison A., Jr. [D-NJ], Sen. Randolph, Jennings [D-WV], Sen. DeConcini, Dennis [D-AZ], Sen. Denton, Jeremiah [R-AL], Sen. Cranston, Alan [D-CA], Sen. Melcher, John [D-MT], Sen. Pell, Claiborne [D-RI], Sen. Nunn, Sam [D-GA], Sen. Metzenbaum, Howard M. [D-OH], Sen. Hollings, Ernest F. [D-SC], Sen. Roth Jr., William V. [R-DE], Sen. Riegle, Donald W., Jr. [D-MI], Sen. Boschwitz, Rudy [R-MN], Sen. Glenn, John H., Jr. [D-OH], Sen. Burdick, Quentin N. [D-ND], Sen. Leahy, Patrick J. [D-VT]

Subjects

Healthcare

Source updated

21 April 2025

Healthcare

Official sourceView documentsShare

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.

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

Timeline

  1. 17 July 1981

    Introduced

    Introduced in Senate

    Source: IntroReferral

  2. 17 July 1981

    Introduced

    Read second time and referred to Senate Committee on Labor and Human Resources.

    Source: IntroReferral

  3. 29 July 1981

    Committee

    Committee on Labor and Human Resources requested executive comment from Health and Human Services Department; GAO; OMB.

    Source: Committee

Votes

No vote records are attached yet.

Versions

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

Documents

1 official file

Leesvertaling

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Sponsors

Related records

Sources

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