0910-AF59 200704 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Supplements and Other Changes to Approved New Animal Drug Applications 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. Substantive, Nonsignificant Previously Published in The Unified Agenda Completed Actions No No 21 CFR 25 21 CFR 500 21 CFR 514 21 CFR 558 21 USC 351 21 USC 352 21 USC 356a 21 USC 360b 21 USC 371 No NPRM 10/01/1999 64 FR 53281 Final Action 12/13/2006 71 FR 74766 No Businesses None No NA Not Collected Dennis Bensley Jr. 0910 Food and Drug Administration FDA 301 827-6956 dennis.bensley@fda.hhs.gov MPN-2, Room 320 (HFV-140), 7500 Standish Place, Rockville MD 20855