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 2016-04-16 article Rules and Regulations D09002ee1c7f64cf3 D09002ee1c7f64d68 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 January and February 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 changes of sponsorship of applications that occurred in January and February. 81 FR 22520 https://www.govinfo.gov/app/details/FR-2016-04-18/2016-08827 2016-08827 fr18ap16-5 4164-01-P Docket No. FDA-2016-N-0002 https://www.govinfo.gov/app/details/FR-2016-04-18/2016-08827 https://www.govinfo.gov/content/pkg/FR-2016-04-18/html/2016-08827.htm https://www.govinfo.gov/content/pkg/FR-2016-04-18/pdf/2016-08827.pdf Animal Drugs Food Animal Feeds 6 p. 22520 22525 81 FR 22520 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 556 21 CFR Part 556 Title 21 Part 558 21 CFR Part 558 New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Federal Register Vol. 81, Issue RULE 2016-08827 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2016-04-18 Docket No. FDA-2016-N-0002 4164-01-P 2016-08827 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 January and February 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 changes of sponsorship of applications that occurred in January and February.

This rule is effective April 18, 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. Animal Drugs Food Animal Feeds New Animal Drugs: Approval of New Animal Drug Applications; Changes of Sponsorship , 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. 74 Office of the Federal Register, National Archives and Records Administration 2016-04-18 continuing daily deposited born digital 409 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-04-18 P0b002ee18f371700 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr18ap16 https://www.govinfo.gov/app/details/FR-2016-04-18 https://www.govinfo.gov/content/pkg/FR-2016-04-18/pdf/FR-2016-04-18.pdf https://www.govinfo.gov/content/pkg/FR-2016-04-18/xml/FR-2016-04-18.xml fdlp 22511 22909 DGPO 2016-04-16 2024-06-02 FR-2016-04-18 machine generated eng FR FR-2016-04-18 81 74