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HHS/FDA RIN: 0910-AF59 Publication ID: Spring 2007 
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: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 25    21 CFR 500    21 CFR 514    21 CFR 558   
Legal Authority: 21 USC 351    21 USC 352    21 USC 356a    21 USC 360b    21 USC 371   
Legal Deadline:  None
Action Date FR Cite
NPRM  10/01/1999  64 FR 53281   
Final Action  12/13/2006  71 FR 74766   
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.
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

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