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HHS/FDA RIN: 0910-AA02 Publication ID: Fall 1997 
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 NADA revisions are expected to include regulations to implement the provisions of the Animal Drug Availability Act of 1996, specifically the definitions of substantial evidence and 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 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: Final Rule Stage 
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    
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:
Claire Lathers
Director, Office of New Animal Drug Evaluation
Department of Health and Human Services
Food and Drug Administration
HFV-100, Center for Veterinary Medicine, 7500 Standish Place,
Rockville, MD 20855
Phone:301 827-1796