Skip to main content
HR 1663 97th Congress House Health Advisory bodies Department of Health and Human Services Drug industry Drug safety and regulation Drugs and narcotics Executive reorganization Federal advisory bodies National Institutes of Health (NIH) Pharmaceutical research

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.

Introduced: February 4, 1981 See on congress.gov
 Everywhere this bill has been 5 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Sep 17, 1982
For Further Action See H.R.5238.
Mar 9, 1981
Subcommittee Hearings Held.
Feb 9, 1981
Referred to Subcommittee on Health and the Environment.
Feb 4, 1981
Referred to House Committee on Energy and Commerce.
Feb 4, 1981
Introduced in House
 Plain-English summary Congressional Research Service

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.

What's happening now September 17, 1982

For Further Action See H.R.5238.

 Committees of jurisdiction 2