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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 |
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Timetable:
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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 |