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HHS/FDA

RIN: 0910-AF78

Publication ID: Spring 2008

Title: Import Tolerances for Unapproved New Animal Drugs
Abstract: FDA plans to publish a proposed rule and a direct final 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	07/00/2008
Direct Final Rule	07/00/2008
NPRM Comment Period End	10/00/2008
Direct Final Rule Comment Period End	10/00/2008

Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Small Entities Affected: No	Federalism: No
Included in the Regulatory Plan: No
RIN Data Printed in the FR: No
Agency Contact: George Kenneth Haibel Veterinary Medical Officer Department of Health and Human Services Food and Drug Administration Room 169 (MPN-4, HFV-6), 7519 Standish Place, Rockville, MD 20855 Phone:240 276-9019 Fax:240 276-9101 Email: george.haibel@fda.hhs.gov