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HHS/FDA

RIN: 0910-AF59

Publication ID: Spring 2005

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: First time 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	07/00/2005
Final Action Effective	09/00/2005

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