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HHS/FDA

RIN: 0910-AF78

Publication ID: Fall 2008

Title: Import Tolerances for Unapproved New Animal Drugs
Abstract: 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 drug residue tolerances (import tolerances) for imported food products of animal origin for drugs that are used in other countries, but that are unapproved new animal drugs in the United States. Food products of animal origin that are in compliance with the import tolerances will not be considered adulterated under the Federal Food, Drug, and Cosmetic Act and may be imported into the United States.
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	06/00/2009
NPRM Comment Period End	09/00/2009

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