Animal Drug Availability Act of 1996
Public Law 104-250 · H.R. 2508 · 104th Congress · began in the House
Signed by Bill Clinton (D) on Oct 9, 1996 · Health
Sponsor: Rep. Wayne Allard (R-CO-4)
Cosponsors (171): Rep. Scott Klug, Rep. Charlie Stenholm,
Passage votes
- HouseVoice vote
- SenateUnanimous consent
Data notes
The final version of the law, as each chamber passed it. A chamber that passed it by voice vote or unanimous consent has no count. “Method not stated” means the record does not say how the chamber voted. Where the record has a member-by-member vote, the “Who voted for it” section shows who voted yea.
Summary
The Congressional Research Service’s plain-language summary of what the law does.
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.
Committees
The committees the bill was sent to, and what each did with it.
Energy and Commerce Committee · House · markup by, referred to, reported bySubcommittee: Health and Environment Subcommittee
Data notes
A committee links to its page only where it exists in the current Congress; older and renamed committees are named without a link.
Timeline
From introduction to signing, newest first: the committees, the floor and the president. 13 actions.
- Oct 9, 1996Became lawBecame law · Became Public Law No: 104-250.
- Became lawBecame law · Signed by President.
- Sep 28, 1996PresidentPresident · Presented to President.
- Sep 25, 1996FloorFloor · Passed Senate without amendment by Unanimous Consent.
- Sep 24, 1996FloorFloor · Motion to reconsider laid on the table Agreed to without objection.
- FloorFloor · On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.
- FloorFloor · Mr. Bilirakis moved to suspend the rules and pass the bill, as amended.
- CommitteeCommittee · Reported by House Energy and Commerce Committee
- Sep 19, 1996CommitteeCommittee · Markup by House Energy and Commerce Committee
- CommitteeCommittee · Discharged from Health and Environment Subcommittee of the House Energy and Commerce Committee
- Nov 6, 1995CommitteeCommittee · Referred to Health and Environment Subcommittee of the House Energy and Commerce Committee
- Oct 19, 1995CommitteeCommittee · Referred to House Energy and Commerce Committee
- IntroducedIntroduced · Introduced in the House
Data notes
Shows the introduction, each committee and subcommittee step the source dates (referral, hearings, markup, report, discharge), and the floor, conference, presidential and became-law steps. Calendar placements, messages between the chambers, amendments and committee report numbers are not shown for laws before the 108th Congress. Two entries the source lists twice are shown once.
Official record
The bill’s full text and every action, including introduction and committee steps, are on Congress.gov. Data through Oct 7, 2026.