H.R.2508 - Animal Drug Availability Act of 1996104th Congress (1995-1996)
Summary: H.R.2508 — 104th Congress (1995-1996)
Passed House amended (09/24/1996)
Animal Drug Availability Act of 1996 - Amends Federal Food, Drug, and Cosmetic Act provisions relating to new animal drugs to redefine "substantial evidence" to mean evidence from one or more adequate and well controlled investigations from which experts could fairly and reasonably conclude that the drug will have the intended effect.
Sets forth requirements regarding approval of a new animal drug containing more than one active ingredient or having labeling suggesting use of the drug in combination with another animal drug.
Entitles any person intending to apply for an investigational exemption to one or more conferences prior to applying.
Mandates implementing regulations that: (1) further define "adequate and well controlled" and "substantial evidence"; and (2) take into account the proposals contained in the citizen petition submitted by the American Veterinary Association and the Animal Health Institute.
Provides for the approval of animal drugs intended for minor species and minor uses.
(Sec. 3) Modifies tolerance provisions to require application disapproval if the labeling's prescribed, recommended, or suggested use will result in a residue in excess of a safe tolerance.
(Sec. 4) Prohibits deeming a new animal drug use unsafe if any edible portion of any animal imported into the United States does not contain residues exceeding an established tolerance. Provides for tolerance establishment.
(Sec. 5) Regulates animal feed drugs that are limited by approved applications to use under the supervision of a licensed veterinarian (veterinary feed directive drugs).
(Sec. 6) Modifies: (1) the circumstances in which a new animal drug must be considered unsafe; and (2) requirements regarding licenses to manufacture animal feeds bearing or containing new animal drugs.