PlainBillCongress, translated.Legislation. Context. Public interest.Congressional Research Service
Version 00 · Introduced in House · Oct 19, 1995
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.)
People & committees
Rep. Allard, Wayne [R-CO-4] · R–CO
Legislative record
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Became Public Law No: 104-250.
Became Public Law No: 104-250.
Signed by President.
Signed by President.
Presented to President.
Presented to President.
Message on Senate action sent to the House.
Passed Senate without amendment by Unanimous Consent. (consideration: CR S11326)
Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR S11326)
Received in the Senate, read twice.
Motion to reconsider laid on the table Agreed to without objection.
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.
DEBATE - The House proceeded with forty minutes of debate.
Considered under suspension of the rules. (consideration: CR H10835-10841)
Mr. Bilirakis moved to suspend the rules and pass the bill, as amended.
Placed on the Union Calendar, Calendar No. 451.
Reported (Amended) by the Committee on Commerce. H. Rept. 104-823.
Reported (Amended) by the Committee on Commerce. H. Rept. 104-823.
Ordered to be Reported (Amended) by Voice Vote.
Committee Consideration and Mark-up Session Held.
Subcommittee on Health and Environment Discharged.
Referred to the Subcommittee on Health and Environment.
Sponsor introductory remarks on measure. (CR E1993)
Referred to the House Committee on Commerce.
Introduced in House
Introduced in House
Primary sources
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Source last updated: Jun 3, 2026. Consult Congress.gov for the current record.
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