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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
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

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