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United States · Law · HR

H.R. 2508 (104th)

Animal Drug Availability Act of 1996

enactedUnited States· United States Congress· EN

Introduced

19 October 1995

Last action

9 October 1996 · President

Status

Became Public Law No: 104-250.

Sponsors

Sen. Allard, Wayne [R-CO], Rep. Klug, Scott L. [R-WI-2], Rep. Stenholm, Charles W. [D-TX-17], Rep. Dingell, John D. [D-MI-12], Rep. Ganske, Greg [R-IA-4], Rep. Barrett, Bill [R-NE-3], Rep. Bereuter, Doug [R-NE-1], Rep. Boehner, John A. [R-OH-8], Rep. Brown, George E., Jr. [D-CA-42], Rep. Bryant, John W. [D-TX-5], Rep. Burton, Dan [R-IN-5], Rep. Buyer, Steve [R-IN-4], Sen. Chambliss, Saxby [R-GA], Rep. Chenoweth-Hage, Helen [R-ID-1], Rep. Coble, Howard [R-NC-6], Rep. Combest, Larry [R-TX-19], Rep. Condit, Gary A. [D-CA-18], Rep. Cooley, Wes [R-OR-2], Rep. Costello, Jerry F. [D-IL-12], Sen. Crapo, Mike [R-ID], Rep. Cubin, Barbara [R-WY-At Large], Rep. de la Garza, E. [D-TX-15], Rep. Dooley, Calvin M. [D-CA-20], Rep. Ehlers, Vernon J. [R-MI-3], Rep. Emerson, Bill [R-MO-8], Sen. Ensign, John [R-NV], Rep. Ewing, Thomas W. [R-IL-15], Rep. Goodlatte, Bob [R-VA-6], Rep. Gordon, Bart [D-TN-6], Rep. Gunderson, Steve [R-WI-3], Rep. Hamilton, Lee H. [D-IN-9], Rep. Hefley, Joel [R-CO-5], Rep. Holden, Tim [D-PA-17], Rep. Hostettler, John N. [R-IN-8], Sen. Johnson, Tim [D-SD], Rep. Kleczka, Gerald D. [D-WI-4], Rep. LaHood, Ray [R-IL-18], Sen. Lincoln, Blanche L. [D-AR], Rep. Largent, Steve [R-OK-1], Rep. Latham, Tom [R-IA-3], Rep. Leach, James A. [R-IA-2], Rep. Lewis, Ron [R-KY-2], Rep. Lightfoot, Jim [R-IA-3], Rep. Lucas, Frank D. [R-OK-3], Rep. McInnis, Scott [R-CO-3], Rep. McIntosh, David M. [R-IN-2], Rep. McKinney, Cynthia A. [D-GA-4], Rep. Miller, Dan [R-FL-13]

Subjects

Healthcare

Source updated

3 June 2026

Healthcare

Official sourceDownload fileView documentsShare

Summary

Animal Drug Availability Act of 1995 - Amends Federal Food, Drug, and Cosmetic Act provisions relating to new animal drugs to redefine "substantial evidence" to mean evidence from one or more scientifically sound studies including, as appropriate, in vitro studies, studies in laboratory animals, bioequivalence studies, and any studies voluntarily undertaken by or for the applicant that provide some assurance that the drug will have the intended effect. Excludes a claim for the use of a drug in a minor species or a minor use of a drug from disapproval, if there is an application filed for the drug which is approved prior to the submission of the claim. Allows consideration, when a new animal drug contains more than one active ingredient or its labeling suggests use of the drug in combination with another animal drug, only of whether any of the active ingredients or any of the drugs in the combination, at the longest withdrawal time of any of the active ingredients or drugs in the combination, exceeds its established tolerance or interferes with the methods of analysis for another of the active ingredients or drugs in the combination. Requires the Secretary to issue proposed regulations implementing the provisions of this section which: (1) further define "substantial evidence;" (2) take into account the proposals contained in the citizen petition submitted by the American Veterinary Association and the Animal Health Institute; and (3) provide for the opportunity for a conference to make a decision establishing a submission or an investigational requirement. (Sec. 4) Requires the Secretary to approve or disapprove the application within 90 (currently 180) days of receipt of the application. (Sec. 5) Requires: (1) the Secretary to refer disputed issues received in writing from an applicant to an advisory committee or to a special Government employee; and (2) the committee or employee to submit a report containing recommendations regarding the matter. (Sec. 6) Requires the Secretary to refuse approval of an application if information submitted with respect to the drug indicates that any use suggested in labeling proposed for that drug will result in a unsafe amount of residue. (Sec. 7) Permits the export of an unsafe (as defined in the Act) new animal drug, if it is not in conflict with the laws of the country to which it is exported. (Currently, such export is prohibited.)

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Timeline

  1. 19 October 1995

    Introduced

    Referred to the House Committee on Commerce.

    Source: IntroReferral

  2. 19 October 1995

    Introduced

    Introduced in House

    Source: IntroReferral

  3. 19 October 1995

    Introduced

    Introduced in House

    Source: IntroReferral

  4. 20 October 1995

    Introduced

    Sponsor introductory remarks on measure. (CR E1993)

    Source: IntroReferral

  5. 6 November 1995

    Referred

    Referred to the Subcommittee on Health and Environment.

    Source: Committee

  6. 19 September 1996

    Reported

    Ordered to be Reported (Amended) by Voice Vote.

    Source: Committee

  7. 19 September 1996

    Committee

    Committee Consideration and Mark-up Session Held.

    Source: Committee

  8. 19 September 1996

    Committee

    Subcommittee on Health and Environment Discharged.

    Source: Committee

  9. 24 September 1996

    Calendars

    Placed on the Union Calendar, Calendar No. 451.

    Source: Calendars

  10. 24 September 1996

    Reported

    Reported (Amended) by the Committee on Commerce. H. Rept. 104-823.

    Source: Committee

  11. 24 September 1996

    Reported

    Reported (Amended) by the Committee on Commerce. H. Rept. 104-823.

    Source: Committee

  12. 24 September 1996

    Introduced

    Received in the Senate, read twice.

    Source: IntroReferral

  13. 24 September 1996

    Passed

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

    Source: Floor

  14. 24 September 1996

    Passed

    On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.

    Source: Floor

  15. 24 September 1996

    Passed

    Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.

    Source: Floor

  16. 24 September 1996

    Floor

    DEBATE - The House proceeded with forty minutes of debate.

    Source: Floor

  17. 24 September 1996

    Floor

    Considered under suspension of the rules. (consideration: CR H10835-10841)

    Source: Floor

  18. 24 September 1996

    Floor

    Mr. Bilirakis moved to suspend the rules and pass the bill, as amended.

    Source: Floor

  19. 25 September 1996

    Passed

    Passed Senate without amendment by Unanimous Consent. (consideration: CR S11326)

    Source: Floor

  20. 25 September 1996

    Passed

    Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR S11326)

    Source: Floor

  21. 26 September 1996

    Floor

    Message on Senate action sent to the House.

    Source: Floor

  22. 28 September 1996

    Floor

    Presented to President.

    Source: Floor

  23. 28 September 1996

    President

    Presented to President.

    Source: President

  24. 9 October 1996

    Became law

    Became Public Law No: 104-250.

    Source: President

  25. 9 October 1996

    Became law

    Signed by President.

    Source: BecameLaw

  26. 9 October 1996

    President

    Signed by President.

    Source: President

Votes

No vote records are attached yet.

Versions

Documents

14 official files

Public Law (text)

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  • Public Law (text)

    Public Law · EN · 10 October 1996

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  • Public Law (PDF)

    Public Law · EN · 10 October 1996

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  • Enrolled Bill (text)

    Enrolled Bill · EN · 25 September 1996

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  • Enrolled Bill (PDF)

    Enrolled Bill · EN · 25 September 1996

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  • Reported in House (text)

    Reported in House · EN · 24 September 1996

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  • Reported in House (PDF)

    Reported in House · EN · 24 September 1996

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  • Engrossed in House (text)

    Engrossed in House · EN · 24 September 1996

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  • Engrossed in House (PDF)

    Engrossed in House · EN · 24 September 1996

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  • Received in Senate (text)

    Received in Senate · EN · 24 September 1996

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  • Received in Senate (PDF)

    Received in Senate · EN · 24 September 1996

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  • Passed House amended

    summary · EN · 24 September 1996

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  • Introduced in House (text)

    Introduced in House · EN · 19 October 1995

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  • Introduced in House (PDF)

    Introduced in House · EN · 19 October 1995

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  • Introduced in House

    summary · EN · 19 October 1995

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