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Animal Drug Availability Act of 1996

Introduced: October 19, 1995 See on congress.gov
 Everywhere this bill has been 22 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Oct 9, 1996
Became Public Law No: 104-250.
Oct 9, 1996
Signed by President.
Sep 28, 1996
Presented to President.
Sep 26, 1996
Message on Senate action sent to the House.
Sep 25, 1996
Passed Senate without amendment by Unanimous Consent. (consideration: CR S11326)
Sep 25, 1996
Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR S11326)
Sep 24, 1996
Received in the Senate, read twice.
Sep 24, 1996
Motion to reconsider laid on the table Agreed to without objection.
Sep 24, 1996
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.
Sep 24, 1996
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.
Sep 24, 1996
DEBATE - The House proceeded with forty minutes of debate.
Sep 24, 1996
Considered under suspension of the rules. (consideration: CR H10835-10841)
Sep 24, 1996
Mr. Bilirakis moved to suspend the rules and pass the bill, as amended.
Sep 24, 1996
Placed on the Union Calendar, Calendar No. 451.
Sep 24, 1996
Reported (Amended) by the Committee on Commerce. H. Rept. 104-823.
Sep 19, 1996
Ordered to be Reported (Amended) by Voice Vote.
Sep 19, 1996
Committee Consideration and Mark-up Session Held.
Sep 19, 1996
Subcommittee on Health and Environment Discharged.
Nov 6, 1995
Referred to the Subcommittee on Health and Environment.
Oct 20, 1995
Sponsor introductory remarks on measure. (CR E1993)
Oct 19, 1995
Referred to the House Committee on Commerce.
Oct 19, 1995
Introduced in House
 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, 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.)

What's happening now October 9, 1996

Became Public Law No: 104-250.

 Committees of jurisdiction 2