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HHS/FDA

RIN: 0910-AB02

Publication ID: Fall 2003

Title: Investigational Use New Animal Drug Regulations(Completion of a Section 610 Review)
Abstract: FDA initiated a review of 21 C.F.R. 511.1 under section 610 of the Regulatory Flexibility Act. The purpose of the section 610 review was to determine if the rule should be amended to minimize adverse economic impacts on small entities. FDA solicited and considered comments on the following: 1) the continued need for the rule; 2) the nature of complaints or comments received concerning the rule; 3) the complexity of the rule; 4) the extent to which the rule overlaps, duplicates, or conflicts with other Federal, State, or local government rules; and 5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule.
Agency: Department of Health and Human Services(HHS)	Priority: Substantive, Nonsignificant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Completed Actions
Major: Undetermined	Unfunded Mandates: No
RFA Section 610 Review: Completion of a Section 610 Review
CFR Citation: 21 CFR 511
Legal Authority: 21 USC 321 21 USC 351 to 353 21 USC 360b 21 USC 371

Legal Deadline: None

Timetable:

Action	Date	FR Cite
ANPRM	11/21/1996	61 FR 59209
ANPRM Comment Period End	01/21/1997
Begin Review	04/03/2000
End Review	06/02/2003

Regulatory Flexibility Analysis Required: Undetermined	Government Levels Affected: None
Small Entities Affected: Businesses	Federalism: No
Included in the Regulatory Plan: No
Agency Contact: Marty Schoenemann Department of Health and Human Services Food and Drug Administration HFV-126, HFV-100, Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 20855 Phone:301 827-0220