View Rule

View EO 12866 Meetings

Printer-Friendly Version Download RIN Data in XML

HHS/FDA

RIN: 0910-AA02

Publication ID: Spring 1996

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 them through detailed guidelines 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. The agency intends to repropose the NADA proposed rule to incorporate some recent changes in procedure. 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: Final Rule Stage
CFR Citation: 21 CFR 514
Legal Authority: 21 USC 360b 21 USC 371

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

Child RIN List:

RIN	Title
0910-AD66	New Animal Drug Approval Process
0910-AD67	Reporting Requirements for Marketed Animal Drugs

Additional Information: Previously reported under RIN 0905-AA96. ^PFor 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) 594-1722. For further information concerning generic animal drugs, contact Lonnie W. Luther, Chief, Generic Animal Drug and Quality Control Staff, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, (301) 594-1623.
Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: None
Small Entities Affected: Businesses
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