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Titles Actions Overview All Actions Cosponsors Committees Related Bills Subjects Latest Summary All Summaries

Titles (6)

Popular Titles

FDA User Fee bill (Identified by CRS)

Short Titles

Short Titles as Enacted for portions of this bill
  • Dietary Supplement Act of 1992
  • Prescription Drug User Fee Act of 1992

Short Titles - House of Representatives

Short Titles as Introduced for portions of this bill
  • Dietary Supplement Act of 1992
  • Prescription Drug User Fee Act of 1992

Official Titles

Official Titles - House of Representatives

Official Title as Introduced

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.


Actions Overview (7)

Date
10/29/1992Became Public Law No: 102-571.
10/29/1992Signed by President.
10/19/1992Presented to President.
10/07/1992Passed/agreed to in Senate: Passed Senate without amendment and an amended preamble by Voice Vote.
10/06/1992Passed/agreed to in House: On passage Passed without objection.
10/06/1992Committee on Energy and Commerce discharged.
10/06/1992Introduced in House

All Actions (14)

Date Chamber
10/29/1992Became Public Law No: 102-571.
10/29/1992Signed by President.
10/19/1992HousePresented to President.
10/09/1992SenateMessage on Senate action sent to the House.
10/07/1992SenatePassed Senate without amendment and an amended preamble by Voice Vote.
10/06/1992SenateReceived in the Senate, read twice.
10/06/1992HouseFor Previous Action See H.R.5952.
10/06/1992-5:12amHouseMotion to reconsider laid on the table Agreed to without objection.
10/06/1992-5:12amHouseOn passage Passed without objection.
10/06/1992-5:11amHouseConsidered by unanimous consent.
10/06/1992-5:11amHouseMr. Waxman asked unanimous consent to discharge from committee and consider.
10/06/1992HouseCommittee on Energy and Commerce discharged.
10/06/1992HouseReferred to the House Committee on Energy and Commerce.
10/06/1992HouseIntroduced in House

Cosponsors (1)

* = Original cosponsor
CosponsorDate Cosponsored
Rep. Waxman, Henry A. [D-CA-24]* 10/06/1992

Committees (1)

Committees, subcommittees and links to reports associated with this bill are listed here, as well as the nature and date of committee activity and Congressional report number.

Committee / Subcommittee Date Activity Reports
House Energy and Commerce10/06/1992 Referred to
10/06/1992 Discharged from

A related bill may be a companion measure, an identical bill, a procedurally-related measure, or one with text similarities. Bill relationships are identified by the House, the Senate, or CRS, and refer only to same-congress measures.


Latest Summary (1)

There is one summary for H.R.6181. View summaries

Shown Here:
Introduced in House (10/06/1992)

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.