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HHS/FDA

RIN: 0910-AA02

Publication ID: Spring 2002

Title: New Animal Drug Approval Process; Implementation of Title I of the Generic Animal Drug and Patent Term Restoration Act (GADPTRA)
Abstract: On December 17, 1991, the Agency published a proposed revision of the existing regulations that is consistent with the current procedural regulations for human drugs, where appropriate. The New Animal Drug Application (NADA) revisions articulate general requirements in regulations containing performance standards and would complement these regulations through detailed guidance on, among other matters, appropriate ways of meeting requirements for submission of chemistry, pharmacology, and statistical data that would better address the intricate scientific issues involved. A separate proposed rule for reporting requirements for marketed animal drugs also was published on that date, and the Agency has since published an interim final rule for which the comment period has ended. The Agency intends to repropose the NADA proposed rule to incorporate some recent changes in procedure. The NADA revisions are expected to include regulations to implement the provisions of the Animal Drug Availability Act of 1996, specifically the definition of flexible labeling, 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 maintain the safety and effectiveness of new animal drugs and enable a more streamlined animal drug application review and approval process which will result in less regulatory burden upon industry and FDA. The Agency also proposes to amend its regulations to implement title I of the Generic Animal Drug and Patent Term Restoration Act, which established new standards for marketing approval of generic copies of animal drugs approved after 1962.
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
CFR Citation: 21 CFR 514
Legal Authority: 21 USC 321 21 USC 351 21 USC 352 21 USC 360b 21 USC 371 21 USC 379e 21 USC 381

Legal Deadline:

Action	Source	Description	Date
Final	Statutory	The deadline applies to the GADPTRA sections. There is no deadline relating to the other sections.	11/16/1989

Timetable:

Action	Date	FR Cite
ANPRM	11/21/1996	61 FR 59209
ANPRM Comment Period End	01/21/1997
Interim Final Rule	02/04/2002	67 FR 5046
Withdrawn - Publication is not projected in the next 12 months	03/20/2002

Additional Information: For information concerning reporting requirements for marketed animal drugs, contact William C. Keller, Director, Division of Surveillance, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301 827-6642. For further information concerning generic animal drugs, contact Lonnie W. Luther, Chief, Quality Assurance Support Team, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301 827-0209.
Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: None
Small Entities Affected: Businesses	Federalism: No
Included in the Regulatory Plan: No
Agency Contact: Bernadette Dunham Director, Office of Minor Use and Minor Species Animal Drug Development Department of Health and Human Services Food and Drug Administration HFV-101, Center for Veterinary Medicine (HFV-50, MPN-4), Room 180, 7519 Standish Place, Rockville, MD 20855 Phone:240 276-9000 Fax:240 276-9001 Email: bernadette.dunham@fda.hhs.gov