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HHS/FDA | RIN: 0910-AG07 | Publication ID: Fall 2016 |
Title: Conditional Approval of New Animal Drugs for Minor Use and Minor Species | |
Abstract:
The Minor Use and Minor Species Animal Health Act of 2004 established new regulatory procedures intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species, as well as uncommon diseases in major animal species. FDA has the authority to provide for animal drug conditional approval after all safety and manufacturing components of a new animal drug approval have been met. For the effectiveness component of a new animal drug review, a reasonable expectation of effectiveness must be established prior to conditional approval. Sponsors then have up to five years to complete full effectiveness and achieve a complete new animal drug approval. |
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Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 516 | |
Legal Authority: 21 U.S.C. 360ccc 21 U.S.C. 371(a) |
Legal Deadline:
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Urvi Desai Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine, MPN1 Room 203 HFV-100, 7520 Standish Place, Rockville, MD 20855 Phone:240 276-8304 Fax:240 276-8297 Email: urvi.desai@fda.hhs.gov |