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 2018-02-14 article Rules and Regulations D09002ee1c7f30977 D09002ee1c7f30a35 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 approval of 71 supplemental new animal drug applications (NADAs) and 35 supplemental abbreviated new animal drug applications (ANADAs) for revised labeling reflecting a change in marketing status from over-the-counter (OTC) use to use by veterinary feed directive (VFD) for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for growth promotion indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were submitted in voluntary compliance with the goals of FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. In addition, the animal drug regulations are being amended to reflect the voluntary withdrawal of approval of certain entire NADAs and ANADAs that were affected by this initiative. The animal drug regulations are also being amended to reflect several non-substantive changes in format. These technical amendments are being made to improve the consistency and readability of the regulations. 81 FR 94991 https://www.govinfo.gov/app/details/FR-2016-12-27/2016-31083 2016-31083 fr27de16-22 4164-01-P Docket No. FDA-2016-N-0002 https://www.govinfo.gov/app/details/FR-2016-12-27/2016-31083 https://www.govinfo.gov/content/pkg/FR-2016-12-27/html/2016-31083.htm https://www.govinfo.gov/content/pkg/FR-2016-12-27/pdf/2016-31083.pdf Animal Drugs Foods Animal Feeds 35 p. 94991 95025 81 FR 94991 Title 21 Part 556 21 CFR Part 556 Title 21 Part 558 21 CFR Part 558 New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Federal Register Vol. 81, Issue RULE 2016-31083 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2016-12-30 Docket No. FDA-2016-N-0002 4164-01-P 2016-31083 Final rule; technical amendment.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of 71 supplemental new animal drug applications (NADAs) and 35 supplemental abbreviated new animal drug applications (ANADAs) for revised labeling reflecting a change in marketing status from over-the-counter (OTC) use to use by veterinary feed directive (VFD) for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for growth promotion indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were submitted in voluntary compliance with the goals of FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. In addition, the animal drug regulations are being amended to reflect the voluntary withdrawal of approval of certain entire NADAs and ANADAs that were affected by this initiative. The animal drug regulations are also being amended to reflect several non-substantive changes in format. These technical amendments are being made to improve the consistency and readability of the regulations.

This rule is effective December 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. Animal Drugs Foods Animal Feeds New Animal Drugs: Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications , george.haibel@fda.hhs.gov http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf Vol. 81, no. 248 Office of the Federal Register, National Archives and Records Administration 2016-12-27 continuing daily deposited born digital 501 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-12-27 P0b002ee198681fbd 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr27de16 https://www.govinfo.gov/app/details/FR-2016-12-27 https://www.govinfo.gov/content/pkg/FR-2016-12-27/pdf/FR-2016-12-27.pdf https://www.govinfo.gov/content/pkg/FR-2016-12-27/xml/FR-2016-12-27.xml fdlp 94909 95396 DGPO 2018-02-14 2024-06-01 FR-2016-12-27 machine generated eng FR FR-2016-12-27 81 248