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.
Public Law 102-571 · H.R. 6181 · 102nd Congress · began in the House
Signed by George H. W. Bush (R) on Oct 29, 1992 · Health
Sponsor: Rep. John Dingell (D-MI-16)
Cosponsors (1): Rep. Henry Waxman
Passage votes
- HouseUnanimous consent
- SenateVoice vote
Data notes
The final version of the law, as each chamber passed it. A chamber that passed it by voice vote or unanimous consent has no count. “Method not stated” means the record does not say how the chamber voted. Where the record has a member-by-member vote, the “Who voted for it” section shows who voted yea.
Summary
The Congressional Research Service’s plain-language summary of what the law does.
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.
Committees
The committees the bill was sent to, and what each did with it.
Data notes
A committee links to its page only where it exists in the current Congress; older and renamed committees are named without a link.
Timeline
From introduction to signing, newest first: the committees, the floor and the president. 11 actions.
- Oct 29, 1992Became lawBecame law · Became Public Law No: 102-571.
- Became lawBecame law · Signed by President.
- Oct 19, 1992PresidentPresident · Presented to President.
- Oct 7, 1992FloorFloor · Passed Senate without amendment and an amended preamble by Voice Vote.
- Oct 6, 1992FloorFloor · Motion to reconsider laid on the table Agreed to without objection.
- FloorFloor · On passage Passed without objection.
- FloorFloor · Mr. Waxman asked unanimous consent to discharge from committee and consider.
- FloorFloor · Considered by unanimous consent.
- CommitteeCommittee · Discharged from House Energy and Commerce Committee
- CommitteeCommittee · Referred to House Energy and Commerce Committee
- IntroducedIntroduced · Introduced in the House
Data notes
Shows the introduction, each committee and subcommittee step the source dates (referral, hearings, markup, report, discharge), and the floor, conference, presidential and became-law steps. Calendar placements, messages between the chambers, amendments and committee report numbers are not shown for laws before the 108th Congress. Two entries the source lists twice are shown once.
Official record
The bill’s full text and every action, including introduction and committee steps, are on Congress.gov. Data through Oct 7, 2026.