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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