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.

Summary

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.

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

Timeline

1. 6 October 1992

   Introduced

   Received in the Senate, read twice.

   Source: IntroReferral

2. 6 October 1992

   Committee

   For Previous Action See H.R.5952.

   Source: Committee

3. 6 October 1992

   Passed

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

   Source: Floor

4. 6 October 1992

   Passed

   On passage Passed without objection.

   Source: Floor

5. 6 October 1992

   Passed

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

   Source: Floor

6. 6 October 1992

   Floor

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

   Source: Floor

7. 6 October 1992

   Floor

   Considered by unanimous consent.

   Source: Floor

8. 6 October 1992

   Discharge

   Committee on Energy and Commerce discharged.

   Source: Discharge

9. 6 October 1992

   Committee

   Committee on Energy and Commerce discharged.

   Source: Committee

10. 6 October 1992

    Introduced

    Referred to the House Committee on Energy and Commerce.

    Source: IntroReferral

11. 6 October 1992

    Introduced

    Introduced in House

    Source: IntroReferral

12. 6 October 1992

    Introduced

    Introduced in House

    Source: IntroReferral

13. 7 October 1992

    Passed

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

    Source: Floor

14. 7 October 1992

    Passed

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

    Source: Floor

15. 9 October 1992

    Floor

    Message on Senate action sent to the House.

    Source: Floor

16. 19 October 1992

    Floor

    Presented to President.

    Source: Floor

17. 19 October 1992

    President

    Presented to President.

    Source: President

18. 29 October 1992

    Became law

    Became Public Law No: 102-571.

    Source: President

19. 29 October 1992

    Became law

    Signed by President.

    Source: BecameLaw

20. 29 October 1992

    President

    Signed by President.

    Source: President

Votes

No vote records are attached yet.

Versions

• Considered and Passed House · — · Download file
• Enrolled Bill · — · Download file
• Received in Senate · — · Download file

Documents

5 official files

• Received in Senate (text)

  Received in Senate · EN

  ViewDownloadOpen at official source

• Enrolled Bill (text)

  Enrolled Bill · EN

  ViewDownloadOpen at official source

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  Vertaal document

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• Considered and Passed House (text)

  Considered and Passed House · EN

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  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

• Public Law (PDF)

  Public Law · EN · 30 October 1992

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  Vertaal document

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• Introduced in House

  summary · EN · 6 October 1992

  Open at official source

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  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Rep. Dingell, John D. [D-MI-12] · D · Sponsor
• Rep. Waxman, Henry A. [D-CA-33] · D · Sponsor
• · hsif00 · Standing

Related records

• related to → Prescription Drug User Fee Act of 1992

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