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HHS/FDA | RIN: 0910-AH27 | Publication ID: Fall 2015 |
Title: ●Labeling Requirement for Approved and Conditionally Approved New Animal Drugs | |
Abstract:
FDA is proposing updated regulations for the labeling of new animal drugs and new regulations that specify the format and content of labeling for prescription (Rx) new animal products, new animal drug products for use in feed, and over-the-counter (OTC) new animal drug products. The objective of the proposed rule is to protect the health of animals by providing more drug information in a more uniform format on the animal drug label. FDA is taking this action to provide pet owners and animal health professionals more complete and consistent information about approved and conditionally approved new animal drugs. |
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Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 201 21 CFR 500 21 CFR 501 21 CFR 510 21 CFR 514 | |
Legal Authority: 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 306b 21 U.S.C. 360ccc 21 U.S.C. 371 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: Undetermined |
Federalism: Undetermined | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Suzanne Sechen Supervisory Animal Scientist Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine, 7500 Standish Place, MPN-2, HFV-137, Rockville, MD 20855 Phone:240 402-0814 Email: suzanne.sechen@fda.hhs.gov |