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 2018_register executive 2018-03-22 article Rules and Regulations D09002ee1c7ea1e77 D09002ee1c7ea1f78 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, Agency, or we) is announcing the availability of a guidance for industry entitled "Application of the Foreign Supplier Verification Program Regulations to the Importation of Live Animals: Guidance for Industry." The purpose of this document is to state FDA's intent to exercise enforcement discretion regarding application of the regulation on foreign supplier verification programs (FSVPs) to importers of certain live animals. The enforcement discretion would apply to importers of live animals that are required to be slaughtered and processed at U.S. Department of Agriculture (USDA) regulated establishments subject to USDA-administered Hazard Analysis and Critical Control Point (HACCP) requirements, or at State-inspected establishments subject to requirements equivalent to the Federal standard. 83 FR 12483 https://www.govinfo.gov/app/details/FR-2018-03-22/2018-05843 2018-05843 fr22mr18-4 4164-01-P Docket No. FDA-2018-D-0721 https://www.govinfo.gov/app/details/FR-2018-03-22/2018-05843 https://www.govinfo.gov/content/pkg/FR-2018-03-22/html/2018-05843.htm https://www.govinfo.gov/content/pkg/FR-2018-03-22/pdf/2018-05843.pdf 3 p. 12483 12485 83 FR 12483 Title 21 Part 1 21 CFR Part 1 Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals: Guidance for Industry; Availability; Federal Register Vol. 83, Issue RULE 2018-05843 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2018-D-0721 4164-01-P 2018-05843 Notification of availability.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry entitled "Application of the Foreign Supplier Verification Program Regulations to the Importation of Live Animals: Guidance for Industry." The purpose of this document is to state FDA's intent to exercise enforcement discretion regarding application of the regulation on foreign supplier verification programs (FSVPs) to importers of certain live animals. The enforcement discretion would apply to importers of live animals that are required to be slaughtered and processed at U.S. Department of Agriculture (USDA) regulated establishments subject to USDA-administered Hazard Analysis and Critical Control Point (HACCP) requirements, or at State-inspected establishments subject to requirements equivalent to the Federal standard.

The announcement of the guidance is published in the Federal Register on March 22, 2018. Sharon Mayl, Office of Foods and Veterinary Medicine, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-4716. Guidance: Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals , https://www.fda.gov/FoodGuidances https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 83, no. 56 Office of the Federal Register, National Archives and Records Administration 2018-03-22 continuing daily deposited born digital 196 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2018-03-22 P0b002ee199c3c94c 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr22mr18 https://www.govinfo.gov/app/details/FR-2018-03-22 https://www.govinfo.gov/content/pkg/FR-2018-03-22/pdf/FR-2018-03-22.pdf https://www.govinfo.gov/content/pkg/FR-2018-03-22/xml/FR-2018-03-22.xml fdlp 12471 12655 DGPO 2018-03-22 2024-06-01 FR-2018-03-22 machine generated eng FR FR-2018-03-22 83 56