Skip to main content
S 773 104th Congress Senate Health Administrative procedure Administrative remedies Agriculture and Food Animals Clinical trials Commerce Conferences Congress Congressional reporting requirements Department of Health and Human Services Drug industry Drug law and legislation Drug utilization Drugs Export controls Exports Federal advisory bodies Food adulteration and inspection Foreign Trade and International Finance

Animal Drug Availability Act of 1995

Introduced: May 9, 1995 See on congress.gov
This bill died when the 104th Congress ended
It never became law before the 104th Congress (1995–1996) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 10 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Sep 26, 1996
Received in the House.
Sep 26, 1996
Held at the desk.
Sep 26, 1996
Message on Senate action sent to the House.
Sep 24, 1996
Senate Committee on Labor and Human Resources discharged by Unanimous Consent.
Sep 24, 1996
Measure laid before Senate. (consideration: CR S11204-11209)
Sep 24, 1996
Passed Senate with an amendment by Unanimous Consent.
Sep 24, 1996
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
May 9, 1995
Read twice and referred to the Committee on Labor and Human Resources.
May 9, 1995
Sponsor introductory remarks on measure. (CR S6351-6352)
May 9, 1995
Introduced in Senate
 Amendments to this bill 1

Amendments propose changes to this bill. Members vote on amendments separately before the final bill vote. An agreed amendment becomes part of the bill; a failed amendment does not.

1 agreed to

AmendmentSponsorPurposeStatusLatest action
SAMDT 5,401 To provide for a substitute amendment. Agreed to Sep 24, 1996
 Ask about this bill AI · grounded in the bill text

Have a question about what this bill does? Ask in plain English; the answer is drawn from the bill's actual text and official record, and it'll tell you when something isn't in the text rather than guess.

AI answers can be imperfect; always confirm against the full bill text.

 Plain-English summary Congressional Research Service

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.)

What's happening now September 26, 1996

Held at the desk.

 Related & companion bills 1
 Bill text 2 versions

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
Cite this page click to expand
APA
U.S. Congress. (2026). S. 773: Animal Drug Availability Act of 1996. 104th Congress. Open America. https://openamerica.io/bill/104-S-773/
MLA
"S. 773: Animal Drug Availability Act of 1996." 104th Congress, 2026, Open America, https://openamerica.io/bill/104-S-773/.
Bluebook (legal)
S. 773, 104th Cong. (2026), https://openamerica.io/bill/104-S-773/.
Markdown link
[S. 773: Animal Drug Availability Act of 1996](https://openamerica.io/bill/104-S-773/)
Report a problem