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 2016-04-20 article Notices D09002ee1c7f64a72 D09002ee1c7f64af5 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 or Agency) is announcing the availability of guidance for industry #231 entitled "Distributor Labeling for New Animal Drugs." This guidance discusses FDA's current thinking with respect to the factors it considers in determining whether to take regulatory action against distributor labeling for a new animal drug that differs from the labeling approved as part of a new animal drug application or abbreviated new animal drug application in ways other than those permitted by regulation. 81 FR 23307 https://www.govinfo.gov/app/details/FR-2016-04-20/2016-09141 2016-09141 fr20ap16-73 4164-01-P Docket No. FDA-2015-D-3056 https://www.govinfo.gov/app/details/FR-2016-04-20/2016-09141 https://www.govinfo.gov/content/pkg/FR-2016-04-20/html/2016-09141.htm https://www.govinfo.gov/content/pkg/FR-2016-04-20/pdf/2016-09141.pdf 2 p. 23307 23308 81 FR 23307 Distributor Labeling for New Animal Drugs; Guidance for Industry; Availability; Federal Register Vol. 81, Issue NOTICE 2016-09141 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2015-D-3056 4164-01-P 2016-09141 Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of guidance for industry #231 entitled "Distributor Labeling for New Animal Drugs." This guidance discusses FDA's current thinking with respect to the factors it considers in determining whether to take regulatory action against distributor labeling for a new animal drug that differs from the labeling approved as part of a new animal drug application or abbreviated new animal drug application in ways other than those permitted by regulation.

Submit either electronic or written comments on Agency guidances at any time. Dorothy McAdams, Center for Veterinary Medicine, Division of Surveillance (HFV-210), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5763, email: dorothy.mcadams@fda.hhs.gov. Guidance for Industry; Availability: Distributor Labeling for New Animal Drugs , dorothy.mcadams@fda.hhs.gov http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm http://www.fda.gov/regulatoryinformation/dockets/default.htm http://www.regulations.gov Vol. 81, no. 76 Office of the Federal Register, National Archives and Records Administration 2016-04-20 continuing daily deposited born digital 273 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-04-20 P0b002ee18f3d208b 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr20ap16 https://www.govinfo.gov/app/details/FR-2016-04-20 https://www.govinfo.gov/content/pkg/FR-2016-04-20/pdf/FR-2016-04-20.pdf https://www.govinfo.gov/content/pkg/FR-2016-04-20/xml/FR-2016-04-20.xml fdlp 23155 23419 DGPO 2016-04-20 2024-06-02 FR-2016-04-20 machine generated eng FR FR-2016-04-20 81 76