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 2014_register executive 2014-05-20 article Rules and Regulations D09002ee1c7fa0e0f D09002ee1c7fa0e82 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) is amending the animal drug regulations to reflect a change of sponsor for 172 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) for oral dosage form new animal drug products from Pfizer, Inc., including its several subsidiaries and divisions, to Zoetis, Inc. FDA is also amending the animal drug regulations to remove entries describing conditions of use for new animal drug products for which no NADA is approved, to make minor corrections, and to reflect a current format. This is being done to increase the accuracy and readability of the regulations. 79 FR 28813 https://www.govinfo.gov/app/details/FR-2014-05-20/2014-10415 2014-10415 fr20my14-4 4160-01-P Docket No. FDA-2014-N-0002 https://www.govinfo.gov/app/details/FR-2014-05-20/2014-10415 https://www.govinfo.gov/content/pkg/FR-2014-05-20/html/2014-10415.htm https://www.govinfo.gov/content/pkg/FR-2014-05-20/pdf/2014-10415.pdf Administrative Practice and Procedure Animal Drugs Labeling Reporting and Recordkeeping Requirements 22 p. 28813 28834 79 FR 28813 Title 21 Part 510 21 CFR Part 510 Title 21 Part 520 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Change of Sponsor; Federal Register Vol. 79, Issue RULE 2014-10415 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2014-05-20 Docket No. FDA-2014-N-0002 4160-01-P 2014-10415 Final rule; technical amendments.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 172 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) for oral dosage form new animal drug products from Pfizer, Inc., including its several subsidiaries and divisions, to Zoetis, Inc. FDA is also amending the animal drug regulations to remove entries describing conditions of use for new animal drug products for which no NADA is approved, to make minor corrections, and to reflect a current format. This is being done to increase the accuracy and readability of the regulations.

This rule is effective May 20, 2014. Steven D. Vaughn, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 240-276-8300, steven.vaughn@fda.hhs.gov. Administrative Practice and Procedure Animal Drugs Labeling Reporting and Recordkeeping Requirements Oral Dosage Form New Animal Drugs; Change of Sponsor , steven.vaughn@fda.hhs.gov Vol. 79, no. 97 Office of the Federal Register, National Archives and Records Administration 2014-05-20 continuing daily deposited born digital 270 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-05-20 P0b002ee1891802e8 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr20my14 https://www.govinfo.gov/app/details/FR-2014-05-20 https://www.govinfo.gov/content/pkg/FR-2014-05-20/pdf/FR-2014-05-20.pdf https://www.govinfo.gov/content/pkg/FR-2014-05-20/xml/FR-2014-05-20.xml fdlp 28809 29068 DGPO 2014-05-20 2024-06-02 FR-2014-05-20 machine generated eng FR FR-2014-05-20 79 97