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HHS/FDA | RIN: 0910-AG45 | Publication ID: Fall 2010 |
Title: Reports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals | |
Abstract: Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA) amended section 512 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 USC 360b) to require that the sponsor of each new animal drug product that contains an antimicrobial agent submit an annual report to the Food and Drug Administration on the amount of each antimicrobial active ingredient in the drug product that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. This rulemaking is intended to establish the implementing regulations for this statutory provision. In addition, FDA is exploring the establishment of other requirements to provide for the collection of more useful drug distribution data. | |
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 514.80 | |
Legal Authority: 21 USC 360b(1)(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: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Martine Hartogensis Deputy Director, Office of Surveillance and Compliance Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine, 7529 Standish Place, MPN-5, Room 302, HFV-200, Rockville, MD 20855 Phone:240 453-6833 Email: martine.hartogensis@fda.hhs.gov |