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HR 6181 - 102

To amend the Federal Food, Drug, and Cosmetic Act to authorize human drug application, prescription drug establishment, and prescription drug product fees and for other purposes.

Became Public Law No: 102-571.

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Healthcare
3 evidence matches
Impact 100% Confidence 90%

Health

To amend the Federal Food, Drug, and Cosmetic Act to authorize human drug application, prescription drug establishment, and prescription drug product fees and for other purposes. Became Public Law No: 102-571. Health

To amend the Federal Food, Drug, and Cosmetic Act to authorize human drug application, prescription drug establishment, and prescription drug product fees and for other purposes. Became Public Law No: 102-571. Health

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Summary

00 Introduced in House Apr 18, 2002

Title I: User Fees - Prescription Drug User Fee Act of 1992 - Amends the Federal Food, Drug, and Cosmetic Act to provide authority for the Secretary of Health and Human Services to assess and collect fees from manufacturers of prescription drugs beginning in FY 1993. Establishes a schedule for prescription drug application and supplement fees, prescription drug establishment fees, and prescription drug product fees. Provides for the annual adjustment of such fees to reflect increases in the Consumer Price Index for urban consumers or increases in Federal pay. Authorizes the Secretary to waive or reduce fees. Prohibits the assessment of fees for a fiscal year after FY 1993 unless appropriations for salaries and expenses of the Food and Drug Administration (FDA) are equal or greater than such appropriations for FY 1992. Credits such fees to the appropriation account for salaries and expenses of the FDA. Authorizes appropriations for FY 1993 through 1997. Provides a mechanism for collecting unpaid fees. Requires the FDA to make annual reports to the Congress on this Act. Requires the Secretary to conduct a study to evaluate whether to impose user fees to supplement appropriated funds to improve the process of reviewing applications for new animal drugs. Requires a report to specified congressional committees on the results of such study. Title II: Dietary Supplements - Dietary Supplement Act of 1992 - Requires the Secretary of Health and Human Services to issue final regulations with respect to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances under the Nutrition Labeling and Education Act of 1990 by December 15, 1993. Prohibits the implementation of such Act prior to the issuance of such regulations. Prohibits the promulgation of regulations that require the use of, or are based upon, recommended daily allowances of vitamins or minerals before November 8, 1993. Requires the Secretary to report to specified congressional committees on enforcement practices of the FDA with respect to such dietary supplements. Requires the Comptroller General to report to such committees on a study of the management activities of the FDA related to such dietary supplements. Requires the Director of the Office of Technology Assessment, in cooperation with the Congressional Research Service and subject to the approval of the Technology Assessment Board to report to such committees on a study of the health outcomes and regulatory systems affecting the development and sale of such dietary supplements.

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Timeline

Oct 29, 1992

Signed by President.

Oct 29, 1992

Signed by President.

Oct 29, 1992

Became Public Law No: 102-571.

Oct 29, 1992

Became Public Law No: 102-571.

Oct 19, 1992

Presented to President.

Oct 19, 1992

Presented to President.

Oct 9, 1992

Message on Senate action sent to the House.

Oct 7, 1992

Passed/agreed to in Senate: Passed Senate without amendment and an amended preamble by Voice Vote.

Oct 7, 1992

Passed Senate without amendment and an amended preamble by Voice Vote.

Oct 6, 1992

Introduced in House

Oct 6, 1992

Introduced in House

Oct 6, 1992

Referred to the House Committee on Energy and Commerce.

Oct 6, 1992

Committee on Energy and Commerce discharged.

Oct 6, 1992

Committee on Energy and Commerce discharged.

Oct 6, 1992

Considered by unanimous consent.

Oct 6, 1992

Mr. Waxman asked unanimous consent to discharge from committee and consider.

Oct 6, 1992

Passed/agreed to in House: On passage Passed without objection.

Oct 6, 1992

On passage Passed without objection.

Oct 6, 1992

Motion to reconsider laid on the table Agreed to without objection.

Oct 6, 1992

For Previous Action See H.R.5952.

Oct 6, 1992

Received in the Senate, read twice.

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