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HHS/FDA RIN: 0910-AF59 Publication ID: Spring 2006 
Title: Supplements and Other Changes to Approved New Animal Drug Applications 
Abstract: The Food and Drug Administration (FDA) is amending its regulations on supplements and other changes to approved new animal drug applications (NADAs) or abbreviated new animal drug applications (ANADAs) to implement the manufacturing changes provision of the Food and Drug Modernization Act of 1997. The final rule requires manufacturers to assess the effect of a manufacturing change on the identity, strength, quality, purity, and potency of a drug as those factors relate to the safety or effectiveness of the drug. The final rule sets forth requirements for changes requiring submission and approval of a supplement before the distribution of the drug made using the change, changes requiring the submission of a supplement at least 30 days prior to the distribution of the drug, changes requiring the submission of a supplement at the time of distribution of the drug, and changes to be described in an annual report. 
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 25; 21 CFR 500; 21 CFR 514; 21 CFR 558 
Legal Authority: 21 USC 356a 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  10/01/1999  64 FR 53281 
Final Action  11/00/2006   
Final Action Effective  01/00/2007   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Dennis Bensley Jr.
Chemist
Department of Health and Human Services
Food and Drug Administration
MPN-2, Room 320 (HFV-140), 7500 Standish Place,
Rockville, MD 20855
Phone:301 827-6956
Email: dennis.bensley@fda.hhs.gov

 
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