0910-AA02 199510 The Regulatory Plan and the Unified Agenda of Federal Regulations 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS New Animal Drug Approval Process; Implementation of Title I of the Generic Animal Drug and Patent Term Restoration Act Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage 21 CFR 514 21 USC 360b 21 USC 371 Statutory Final 11/16/1989 The deadline applies to the GADPTRA sections. There is no deadline relating to the other sections. No 0910-AD66 New Animal Drug Approval Process 0910-AD67 Reporting Requirements for Marketed Animal Drugs Previously reported under RIN 0905-AA96. ^PFor information concerning reporting requirements for marketed animal drugs, contact William C. Keller, Director, Division of Surveillance, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, (301) 594-1722. For further information concerning generic animal drugs, contact Lonnie W. Luther, Chief, Generic Animal Drug and Quality Control Staff, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, (301) 594-1623. Yes Businesses None NA Not Collected Bernadette Dunham 0910 Food and Drug Administration FDA 240 276-9000 240 276-9001 bernadette.dunham@fda.hhs.gov HFV-101, Center for Veterinary Medicine (HFV-50, MPN-4), Room 180, 7519 Standish Place, Rockville MD 20855 Revising Text to Reduce Burden or Duplication, or Streamline Requirements