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HHS/FDA | RIN: 0910-AG45 | Publication ID: Spring 2014 |
Title: Reports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals | |
Abstract: This proposed rule would require that the sponsor of each antimicrobial new animal drug product submit an annual report to FDA on the amount of each approved or conditionally approved antimicrobial active ingredient in the drug product that is sold or distributed for use in food-producing animals, including any distributor-labeled product. In addition to codifying these requirements, FDA is exploring other requirements for the collection of additional drug distribution data. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 514.80 | |
Legal Authority: 21 USC 360b(l)(3) |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: Yes | |
RIN Data Printed in the FR: No | |
Agency Contact: Sharon Benz Supervisory Animal Scientist Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine, MPN-4, Room 2648, HFV-220, 7519 Standish Place, Rockville, MD 20855 Phone:240 402-5939 Email: sharon.benz@fda.hhs.gov |