Orphan Drug Act

Summary

Orphan Drug Act - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to promulgate regulations to exempt from such Act drugs intended solely for drug treatment investigations. Defines "drug treatment investigation" as an investigation of a drug which involves human participants with a rare disease or condition. Establishes in the Department of Health and Human Services an interagency committee known as the Committee on Orphan Drug Development. Makes it the function of such committee to promote the development of drugs for rare diseases or conditions (orphan drugs). Requires the Director of the National Institutes of Health (NIH) to submit to the Committee an annual report on the rare disease and condition research activities of NIH. Requires the Committee to report by June 1 of each year to the appropriate congressional committees on its activities and the results of its evaluations, including the report submitted by NIH. Amends the Internal Revenue Code to allow a tax credit for qualified experimental expenses incurred while researching orphan drugs.

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Timeline

1. 15 December 1981

   Introduced

   Referred to House Committee on Energy and Commerce.

   Source: IntroReferral

2. 15 December 1981

   Introduced

   Introduced in House

   Source: IntroReferral

3. 15 December 1981

   Introduced

   Introduced in House

   Source: IntroReferral

4. 25 January 1982

   Referred

   Referred to Subcommittee on Health and the Environment.

   Source: Committee

5. 8 March 1982

   Committee

   Subcommittee Hearings Held.

   Source: Committee

6. 15 September 1982

   Reported

   Ordered to be Reported (Amended).

   Source: Committee

7. 15 September 1982

   Committee

   Committee Consideration and Mark-up Session Held.

   Source: Committee

8. 15 September 1982

   Committee

   Subcommittee on Health and the Environment Discharged.

   Source: Committee

9. 17 September 1982

   Reported

   Reported to House (Amended) by House Committee on Energy and Commerce. Report No: 97-840 (Part I).

   Source: Committee

10. 17 September 1982

    Reported

    Reported to House (Amended) by House Committee on Energy and Commerce. Report No: 97-840 (Part I).

    Source: Committee

11. 28 September 1982

    Introduced

    Received in the Senate and read twice and referred to the Committee on Labor and Human Resources.

    Source: IntroReferral

12. 28 September 1982

    Passed

    Passed House (Amended) by Voice Vote.

    Source: Floor

13. 28 September 1982

    Passed

    Passed/agreed to in House: Passed House (Amended) by Voice Vote.

    Source: Floor

14. 28 September 1982

    Floor

    Called up by House Under Suspension of Rules.

    Source: Floor

15. 1 October 1982

    ResolvingDifferences

    Senate insists on its amendments, asks for a conference, appoints conferees Hatch; Quayle; Hawkins; Kennedy; Metzenbaum.

    Source: ResolvingDifferences

16. 1 October 1982

    Floor

    Considered by Senate.

    Source: Floor

17. 1 October 1982

    Passed

    Passed/agreed to in Senate: Passed Senate with amendments by Voice Vote.

    Source: Floor

18. 1 October 1982

    Discharge

    Senate Committee on Labor and Human Resources discharged by Unanimous Consent.

    Source: Discharge

19. 1 October 1982

    Committee

    Senate Committee on Labor and Human Resources discharged by Unanimous Consent.

    Source: Committee

20. 14 December 1982

    ResolvingDifferences

    House Concurred, in Senate Amendments , with Amendments by Voice Vote.

    Source: ResolvingDifferences

21. 14 December 1982

    NotUsed

    Resolving differences -- House actions: House Concurred, in Senate Amendments , with Amendments by Voice Vote.

    Source: NotUsed

22. 17 December 1982

    Passed

    Senate agreed to the House amendment to the Senate amendment by Voice Vote.

    Source: ResolvingDifferences

23. 17 December 1982

    Passed

    Resolving differences -- Senate actions: Senate agreed to the House amendment to the Senate amendment by Voice Vote.

    Source: NotUsed

24. 23 December 1982

    Floor

    Presented to President.

    Source: Floor

25. 23 December 1982

    President

    Presented to President.

    Source: President

26. 23 December 1982

    Floor

    Measure Signed in Senate.

    Source: Floor

27. 4 January 1983

    Became law

    Became Public Law No: 97-414.

    Source: President

28. 4 January 1983

    President

    Signed by President.

    Source: President

29. 4 January 1983

    Became law

    Signed by President.

    Source: BecameLaw

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

6 official files

• Public Law (PDF)

  Public Law · EN · 5 January 1983

  ViewDownloadOpen at official source

• House agreed to Senate amendment with amendment

  summary · EN · 14 December 1982

  Open at official source

• Passed Senate amended

  summary · EN · 1 October 1982

  Open at official source

• Passed House amended

  summary · EN · 28 September 1982

  Open at official source

• Reported to House amended, Part I

  summary · EN · 17 September 1982

  Open at official source

• Introduced in House

  summary · EN · 15 December 1981

  Open at official source

Sponsors

• Rep. Waxman, Henry A. [D-CA-24] · D · Sponsor
• Rep. Weiss, Ted [D-NY-17] · D · Sponsor
• Rep. Walgren, Doug [D-PA-18] · D · Sponsor
• Sen. Wyden, Ron [D-OR] · D · Sponsor
• Rep. Moffett, Toby [D-CT-6] · D · Sponsor
• Rep. Leland, Mickey [D-TX-18] · D · Sponsor
• Rep. Ottinger, Richard L. [D-NY-24] · D · Sponsor
• Rep. Wirth, Timothy [D-CO-2] · D · Sponsor
• Rep. Mottl, Ronald M. [D-OH-23] · D · Sponsor
• Rep. Akaka, Daniel K. [D-HI-2] · D · Sponsor
• Rep. Barnes, Michael D. [D-MD-8] · D · Sponsor
• Rep. Beilenson, Anthony C. [D-CA-23] · D · Sponsor
• Rep. Dixon, Julian C. [D-CA-28] · D · Sponsor
• Rep. Shamansky, Bob [D-OH-12] · D · Sponsor
• Rep. Taylor, G. [R-MO-7] · R · Sponsor
• Rep. Fish, Hamilton, Jr. [R-NY-25] · R · Cosponsor
• Rep. Roe, Robert A. [D-NJ-8] · D · Cosponsor
• Rep. Wolf, Frank R. [R-VA-10] · R · Cosponsor
• Rep. Rinaldo, Matthew J. [R-NJ-12] · R · Cosponsor
• Rep. Hughes, William J. [D-NJ-2] · D · Cosponsor
• Rep. Smith, Joseph F. [D-PA-3] · D · Cosponsor
• Rep. Yatron, Gus [D-PA-6] · D · Cosponsor
• Rep. Matsui, Robert T. [D-CA-3] · D · Cosponsor
• Rep. Chisholm, Shirley [D-NY-12] · D · Cosponsor
• Rep. Daub, Hal [R-NE-2] · R · Cosponsor
• Rep. Foglietta, Thomas M. [D-PA-1] · D · Cosponsor
• Sen. Schumer, Charles E. [D-NY] · D · Cosponsor
• Rep. Molinari, Guy [R-NY-14] · R · Cosponsor
• Rep. Solarz, Stephen J. [D-NY-13] · D · Cosponsor
• Rep. Edwards, Don [D-CA-10] · D · Cosponsor
• Rep. Lehman, William [D-FL-13] · D · Cosponsor
• Del. Fauntroy, Walter E. [D-DC-At Large] · D · Cosponsor
• Rep. Donnelly, Brian J. [D-MA-11] · D · Cosponsor
• Rep. Traxler, Bob [D-MI-8] · D · Cosponsor
• Rescom. Corrada, Baltasar [I-PR-At Large] · I · Cosponsor
• Rep. Mitchell, Donald J. [R-NY-31] · R · Cosponsor
• Sen. Mikulski, Barbara A. [D-MD] · D · Cosponsor
• Rep. Yates, Sidney R. [D-IL-9] · D · Cosponsor
• Sen. Gore, Albert, Jr. [D-TN] · D · Cosponsor
• Rep. Oberstar, James L. [D-MN-8] · D · Cosponsor
• Rep. Edgar, Robert W. [D-PA-7] · D · Cosponsor
• Rep. Simon, Paul [D-IL-24] · D · Cosponsor
• Rep. Mazzoli, Romano L. [D-KY-3] · D · Cosponsor
• Rep. Murphy, Austin J. [D-PA-22] · D · Cosponsor
• Rep. Santini, James D. [D-NV-98] · D · Cosponsor
• Rep. O'Brien, George M. [R-IL-17] · R · Cosponsor
• Rep. Mineta, Norman Y. [D-CA-13] · D · Cosponsor
• Rep. Kastenmeier, Robert W. [D-WI-2] · D · Cosponsor

Showing 48 of 175 sponsors and actors.

Related records

• related to → 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.