Animal Drug Availability Act of 1996

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, tissue residue 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. Directs the Secretary of Health and Human Services to consider the following issues when a new animal drug contains more than one active ingredient, or the labeling of the drug suggests use of the drug in combination with another animal drug: (1) whether any active ingredient or any combination of drugs alters the safe concentration of another of the active ingredients or drugs in the combination; (2) whether each of the active ingredients or drugs in the combination have been shown to contribute to the same intended effect; and (3) whether each of the active ingredients or drugs in the combination has an identified target population for which dosing with the active ingredients or combination represents appropriate concurrent therapy. 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; (3) provide for a conference to make a decision establishing a submission or an investigational requirement; and (4) define the kinds of evidence an applicant may use to establish the contribution of each active ingredient and to establish the appropriateness of concurrent therapy in a new animal drug, or new animal drug used in combination with another drug. (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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Documents

6 official files

• Engrossed in Senate (text)

  Engrossed in Senate · EN · 24 September 1996

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• Engrossed in Senate (PDF)

  Engrossed in Senate · EN · 24 September 1996

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• Passed Senate amended

  summary · EN · 24 September 1996

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• Introduced in Senate (text)

  Introduced in Senate · EN · 9 May 1995

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 9 May 1995

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• Introduced in Senate

  summary · EN · 9 May 1995

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