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 2012_register executive 2012-07-27 article Proposed Rules D09002ee1c7fcab43 D09002ee1c7fcabb6 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 soliciting comments regarding potential changes to its regulations relating to records and reports for approved new animal drugs. FDA is considering revisions to this regulation to incorporate the requirements of section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105). As part of that process, FDA is reviewing other reporting requirements applicable to antimicrobial new animal drug sponsors to determine whether additional information should be reported. Collecting data on antimicrobial drugs used in food-producing animals will assist FDA in tracking antimicrobial use trends and examining how such trends may relate to antimicrobial resistance. 77 FR 44177 https://www.govinfo.gov/app/details/FR-2012-07-27/2012-18366 2012-18366 fr27jy12-22 4160-01-P Docket No. FDA-2012-N-0447 https://www.govinfo.gov/app/details/FR-2012-07-27/2012-18366 https://www.govinfo.gov/content/pkg/FR-2012-07-27/html/2012-18366.htm https://www.govinfo.gov/content/pkg/FR-2012-07-27/pdf/2012-18366.pdf 3 p. 44177 44179 77 FR 44177 Title 21 Part 514 21 CFR Part 514 Antimicrobial Animal Drug Sales and Distribution Reporting; Federal Register Vol. 77, Issue PRORULE 2012-18366 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2012-09-25 Docket No. FDA-2012-N-0447 4160-01-P 2012-18366 Advance notice of proposed rulemaking.

The Food and Drug Administration (FDA or Agency) is soliciting comments regarding potential changes to its regulations relating to records and reports for approved new animal drugs. FDA is considering revisions to this regulation to incorporate the requirements of section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105). As part of that process, FDA is reviewing other reporting requirements applicable to antimicrobial new animal drug sponsors to determine whether additional information should be reported. Collecting data on antimicrobial drugs used in food-producing animals will assist FDA in tracking antimicrobial use trends and examining how such trends may relate to antimicrobial resistance.

Submit electronic or written comments by September 25, 2012. Neal Bataller, Center for Veterinary Medicine (HFV-210), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9062, email: Neal.Bataller@fda.hhs.gov. Antimicrobial Animal Drug Sales and Distribution Reporting , Neal.Bataller@fda.hhs.gov http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm http://www.gao.gov/new.items/d11801.pdf http://www.regulations.gov Vol. 77, no. 145 Office of the Federal Register, National Archives and Records Administration 2012-07-27 continuing daily deposited born digital 332 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2012-07-27 P0b002ee1830337d6 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr27jy12 https://www.govinfo.gov/app/details/FR-2012-07-27 https://www.govinfo.gov/content/pkg/FR-2012-07-27/pdf/FR-2012-07-27.pdf https://www.govinfo.gov/content/pkg/FR-2012-07-27/xml/FR-2012-07-27.xml fdlp 44107 44428 DGPO 2012-07-27 2024-06-03 FR-2012-07-27 machine generated eng FR FR-2012-07-27 77 145