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 2021_register executive 2021-09-21 article Rules and Regulations D09002ee1c7ae16f6 D09002ee1c7ae17d7 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, the Agency, we) is issuing a final rule that establishes procedures by which we may establish, amend, or revoke tolerances for residues of new animal drugs in any edible portion of any animal imported into the United States (import tolerances). These import tolerances provide a basis for the legal marketing of such animal-derived food. 86 FR 52401 https://www.govinfo.gov/app/details/FR-2021-09-21/2021-19967 2021-19967 fr21se21-4 RIN 0910-AF78 4164-01-P Docket No. FDA-2001-N-0075 (formerly Docket No. 2001N-0284) https://www.govinfo.gov/app/details/FR-2021-09-21/2021-19967 https://www.govinfo.gov/content/pkg/FR-2021-09-21/html/2021-19967.htm https://www.govinfo.gov/content/pkg/FR-2021-09-21/pdf/2021-19967.pdf Administrative Practice and Procedure News Media Confidential Business Information Courts Freedom of Information Government Employees Environmental Impact Statements Foreign Relations Reporting and Recordkeeping Requirements Animal Drugs Animal Feeds Cancer Labeling Packaging and Containers Polychlorinated Biphenyls (Pcbs) 12 p. 52401 52412 86 FR 52401 Title 21 Part 10 21 CFR Part 10 Title 21 Part 20 21 CFR Part 20 Title 21 Part 25 21 CFR Part 25 Title 21 Part 500 21 CFR Part 500 Title 21 Part 510 21 CFR Part 510 RIN 0910-AF78 Import Tolerances for Residues of Unapproved New Animal Drugs in Food; Federal Register Vol. 86, Issue RULE 2021-19967 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2022-01-19 2021-10-21 Docket No. FDA-2001-N-0075 (formerly Docket No. 2001N-0284) 4164-01-P 2021-19967 Final rule.

The Food and Drug Administration (FDA, the Agency, we) is issuing a final rule that establishes procedures by which we may establish, amend, or revoke tolerances for residues of new animal drugs in any edible portion of any animal imported into the United States (import tolerances). These import tolerances provide a basis for the legal marketing of such animal-derived food.

This rule is effective January 19, 2022. Submit written comments (including recommendations) on information collection issues under the Paperwork Reduction Act of 1995 (PRA) by October 21, 2021 (see section IX, the "Paperwork Reduction Act of 1995" section of this document). With regard to the final rule: Charli Long-Medrano, Center for Veterinary Medicine (HFV-150), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0850, charli.long- medrano@fda.hhs.gov. Administrative Practice and Procedure News Media Confidential Business Information Courts Freedom of Information Government Employees Environmental Impact Statements Foreign Relations Reporting and Recordkeeping Requirements Animal Drugs Animal Feeds Cancer Labeling Packaging and Containers Polychlorinated Biphenyls (Pcbs) Import Tolerances for Residues of Unapproved New Animal Drugs in Food, charli.long-medrano@fda.hhs.gov cvmesubmitter@fda.hhs.gov ESGHelpDEsk@fda.hhs.gov PRAStaff@fda.hhs.gov https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations https://www.fda.gov/animal-veterinary/guidance-industry/human-food-safety-guidances https://www.fda.gov/AnimalVeterinary/Products/ImportExports/ucm315830.htm https://www.fda.gov/industry/electronic-submissions-gateway https://www.fda.gov/media/69949/download https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-159-vich-gl36-studies-evaluate-safety-residues-veterinary-drugs-human-food-general-approach https://www.reginfo.gov/public/do/PRAMain Vol. 86, no. 180 Office of the Federal Register, National Archives and Records Administration 2021-09-21 continuing daily deposited born digital 211 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2021-09-21 P0b002ee1b0951c06 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr21se21 https://www.govinfo.gov/app/details/FR-2021-09-21 https://www.govinfo.gov/content/pkg/FR-2021-09-21/pdf/FR-2021-09-21.pdf https://www.govinfo.gov/content/pkg/FR-2021-09-21/xml/FR-2021-09-21.xml fdlp 52385 52586 DGPO 2021-09-21 2024-05-30 FR-2021-09-21 machine generated eng FR FR-2021-09-21 86 180