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 2018-02-13 article Proposed Rules D09002ee1c7f342b0 D09002ee1c7f34315 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 we) is proposing to amend our 2012 document entitled "New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food." The document proposed to revise the animal drug regulations regarding tolerances for residues of approved and conditionally approved new animal drugs in food by standardizing, simplifying, and clarifying the determination standards and codification style. We also proposed to add definitions for key terms. We are taking this action to more clearly explain our current thinking about certain provisions of the 2012 document based on comments from stakeholders, and to more accurately reflect the rationale FDA relied on in the past to approve certain new animal drugs without a tolerance. We are reopening the comment period only with respect to the specific issues identified in this supplemental proposed rule. 81 FR 74962 https://www.govinfo.gov/app/details/FR-2016-10-28/2016-26043 2016-26043 fr28oc16-11 RIN 0910-AG17 4164-01-P Docket No. FDA-2012-N-1067 https://www.govinfo.gov/app/details/FR-2016-10-28/2016-26043 https://www.govinfo.gov/content/pkg/FR-2016-10-28/html/2016-26043.htm https://www.govinfo.gov/content/pkg/FR-2016-10-28/pdf/2016-26043.pdf Administrative Practice and Procedure Animal Drugs Confidential Business Information Reporting and Recordkeeping Requirements Foods 5 p. 74962 74966 81 FR 74962 Title 21 Part 514 21 CFR Part 514 Title 21 Part 556 21 CFR Part 556 RIN 0910-AG17 New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food; Federal Register Vol. 81, Issue PRORULE 2016-26043 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2016-12-27 Docket No. FDA-2012-N-1067 4164-01-P 2016-26043 Proposed rule; supplemental notice of proposed rulemaking.

The Food and Drug Administration (FDA or we) is proposing to amend our 2012 document entitled "New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food." The document proposed to revise the animal drug regulations regarding tolerances for residues of approved and conditionally approved new animal drugs in food by standardizing, simplifying, and clarifying the determination standards and codification style. We also proposed to add definitions for key terms. We are taking this action to more clearly explain our current thinking about certain provisions of the 2012 document based on comments from stakeholders, and to more accurately reflect the rationale FDA relied on in the past to approve certain new animal drugs without a tolerance. We are reopening the comment period only with respect to the specific issues identified in this supplemental proposed rule.

Submit either electronic or written comments on this proposed rule by December 27, 2016. Dong Yan, Center for Veterinary Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0825, dong.yan@fda.hhs.gov. Administrative Practice and Procedure Animal Drugs Confidential Business Information Reporting and Recordkeeping Requirements Foods New Animal Drugs: Updating Tolerances for Residues of New Animal Drugs in Food , dong.yan@fda.hhs.gov http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM448430.pdf http://www.fda.gov/regulatoryinformation/dockets/default.htm http://www.regulations.gov http://www.who.int/foodsafety/publications/chemical-food/en/ Vol. 81, no. 209 Office of the Federal Register, National Archives and Records Administration 2016-10-28 continuing daily deposited born digital 408 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-10-28 P0b002ee198648452 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr28oc16 https://www.govinfo.gov/app/details/FR-2016-10-28 https://www.govinfo.gov/content/pkg/FR-2016-10-28/pdf/FR-2016-10-28.pdf https://www.govinfo.gov/content/pkg/FR-2016-10-28/xml/FR-2016-10-28.xml fdlp 74917 75314 DGPO 2018-02-13 2024-06-01 FR-2016-10-28 machine generated eng FR FR-2016-10-28 81 209