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HHS/FDA

RIN: 0910-AF78

Publication ID: Spring 2009

Title: Import Tolerances for Unapproved New Animal Drugs
Abstract: The Food and Drug Administration (FDA) plans to publish a proposed rule related to the implementation of the import tolerances provision of the Animal Drug Availability Act of 1996 (ADAA). The ADAA authorizes FDA to establish tolerances for residues of unapproved new animal drugs in food of animal origin imported into the United States (import tolerances). It is unlawful to import animal-derived food that bears or contains residues of a new animal drug that is not approved in the United States, unless FDA has estalished an import tolerance for that new animal drug and the residue does not exceed that tolerance.
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: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 USC 360b(a)(6) 21 USC 371

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM	03/00/2010
NPRM Comment Period End	06/00/2010

Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Small Entities Affected: No	Federalism: No
Included in the Regulatory Plan: No
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: No
Agency Contact: Frances Pell Consumer Safety Officer Department of Health and Human Services Food and Drug Administration E140/HFV-235, Center for Veterinary Medicine, Room 101 (MPN-4, HFV-235), 7500 Standish Place, Rockville, MD 20855 Phone:240 276-9211 Fax:240 276-9241 Email: frances.pell@fda.hhs.gov