United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2016_register executive 2018-02-09 article Rules and Regulations D09002ee1c7f375b6 D09002ee1c7f37768 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July and August 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor's address. 81 FR 67149 https://www.govinfo.gov/app/details/FR-2016-09-30/2016-23230 2016-23230 fr30se16-20 4164-01-P Docket No. FDA-2016-N-0002 https://www.govinfo.gov/app/details/FR-2016-09-30/2016-23230 https://www.govinfo.gov/content/pkg/FR-2016-09-30/html/2016-23230.htm https://www.govinfo.gov/content/pkg/FR-2016-09-30/pdf/2016-23230.pdf Administrative Practice and Procedure Animal Drugs Labeling Reporting and Recordkeeping Requirements Animal Feeds 5 p. 67149 67153 81 FR 67149 Title 21 Part 510 21 CFR Part 510 Title 21 Part 520 21 CFR Part 520 Title 21 Part 522 21 CFR Part 522 Title 21 Part 524 21 CFR Part 524 Title 21 Part 529 21 CFR Part 529 Title 21 Part 558 21 CFR Part 558 New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address; Federal Register Vol. 81, Issue RULE 2016-23230 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2016-09-30 Docket No. FDA-2016-N-0002 4164-01-P 2016-23230 Final rule; technical amendment.

The Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July and August 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor's address.

This rule is effective September 30, 2016. George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, george.haibel@fda.hhs.gov. Administrative Practice and Procedure Animal Drugs Labeling Reporting and Recordkeeping Requirements Animal Feeds New Animal Drugs: Approval of New Animal Drug Applications; Change of Sponsor's Address , george.haibel@fda.hhs.gov http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm Vol. 81, no. 190 Office of the Federal Register, National Archives and Records Administration 2016-09-30 continuing daily deposited born digital 820 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-09-30 P0b002ee1985eda21 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr30se16 https://www.govinfo.gov/app/details/FR-2016-09-30 https://www.govinfo.gov/content/pkg/FR-2016-09-30/pdf/FR-2016-09-30.pdf https://www.govinfo.gov/content/pkg/FR-2016-09-30/xml/FR-2016-09-30.xml fdlp 67091 67899 DGPO 2018-02-09 2024-06-01 FR-2016-09-30 machine generated eng FR FR-2016-09-30 81 190