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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

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Status

Became Public Law No: 104-250.

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Source updated

3 June 2026

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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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