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 2018-02-02 article Notices D09002ee1c7f6a570 D09002ee1c7f6a615 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 a guidance for industry (GFI) #226 entitled "Target Animal Safety Data Presentation and Statistical Analysis." The purpose of this document is to provide recommendations to industry regarding the presentation and statistical analyses of target animal safety (TAS) data submitted to the Center for Veterinary Medicine (CVM) as part of a study report to support approval of a new animal drug. These recommendations apply to TAS data generated from both TAS and field effectiveness studies conducted in companion animals (e.g., dogs, cats, and horses) and food animals (e.g., swine, ruminants, fish, and poultry). 81 FR 3429 https://www.govinfo.gov/app/details/FR-2016-01-21/2016-01098 2016-01098 fr21ja16-81 4164-01-P Docket No. FDA-2015-D-0839 https://www.govinfo.gov/app/details/FR-2016-01-21/2016-01098 https://www.govinfo.gov/content/pkg/FR-2016-01-21/html/2016-01098.htm https://www.govinfo.gov/content/pkg/FR-2016-01-21/pdf/2016-01098.pdf 2 p. 3429 3430 81 FR 3429 Target Animal Safety Data Presentation and Statistical Analysis; Guidance for Industry; Availability; Federal Register Vol. 81, Issue NOTICE 2016-01098 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2015-D-0839 4164-01-P 2016-01098 Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry (GFI) #226 entitled "Target Animal Safety Data Presentation and Statistical Analysis." The purpose of this document is to provide recommendations to industry regarding the presentation and statistical analyses of target animal safety (TAS) data submitted to the Center for Veterinary Medicine (CVM) as part of a study report to support approval of a new animal drug. These recommendations apply to TAS data generated from both TAS and field effectiveness studies conducted in companion animals (e.g., dogs, cats, and horses) and food animals (e.g., swine, ruminants, fish, and poultry).

Submit either electronic or written comments on Agency guidances at any time. Virginia Recta, Center for Veterinary Medicine (HFV-160), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0840, virginia.recta@fda.hhs.gov, Guidance: Target Animal Safety Data Presentation and Statistical Analysis , virginia.recta@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. 13 Office of the Federal Register, National Archives and Records Administration 2016-01-21 continuing daily deposited born digital 422 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-01-21 P0b002ee198334fbb 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr21ja16 https://www.govinfo.gov/app/details/FR-2016-01-21 https://www.govinfo.gov/content/pkg/FR-2016-01-21/pdf/FR-2016-01-21.pdf https://www.govinfo.gov/content/pkg/FR-2016-01-21/xml/FR-2016-01-21.xml fdlp 3289 3698 DGPO 2018-02-02 2024-06-02 FR-2016-01-21 machine generated eng FR FR-2016-01-21 81 13