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Parent RIN:   0910-AA02
HHS/FDA RIN: 0910-AD66 Publication ID: Fall 1996 
Title: New Animal Drug Approval Process 
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 
Major: No  Unfunded Mandates: No 
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 
Timetable:
Action Date FR Cite
NPRM  12/17/1991  56 FR 65544   
NPRM  04/00/1997    
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: