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HHS/FDA RIN: 0910-AB02 Publication ID: Spring 2002 
Title: Investigational Use New Animal Drug Regulations(Section 610 Review) 
Abstract: FDA is proposing to revise its regulations governing investigational use of new animal drugs by proposing to delete 21 CFR 511 and establish in 21 CFR part 512 revised investigational use of new animal drug regulations. The investigational use new animal drug regulations are expected to include regulations to implement provisions of the Animal Drug Availability Act of 1996, specifically presubmission conferences, and implement parts of the President's National Performance Report, "Reinventing the Regulation of Animal Drugs," May 1996. In the reinventing regulations report, FDA proposed to revise its regulations to reflect numerous new process changes and programs that will enable a more streamlined animal drug application review and approval process, and that would result in less regulatory burden upon industry and FDA while maintaining the safety and effectiveness of new animal drugs. In addition, FDA is initiating a review of this rule under section 610 of the Regulatory Flexibility Act. The purpose of the section 610 review is to determine if the rule should be amended to minimize adverse economic impacts on small entities. FDA will solicit and consider 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: Long-Term Actions 
Major: Undetermined  Unfunded Mandates: Undetermined 
RFA Section 610 Review: Section 610 Review 
CFR Citation: 21 CFR 511; 21 CFR 512 
Legal Authority: 5 USC 610; 21 USC 351; 21 USC 353; 21 USC 360b; 21 USC 371; 21 USC 321; 21 USC 352 
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  12/00/2003   
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: Undetermined 
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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