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 2024_register executive 2024-05-23 article Notices D09002ee1c74a6c3c D09002ee1c74a6cc2 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 draft revised guidance for industry (GFI) #115 (VICH GL22) entitled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1)." This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). In order to establish the safety of veterinary drug residues in human food, a number of toxicological evaluations are required, including the assessment of any effects on reproduction. The objective of this guidance is to ensure international harmonization of reproduction testing that is appropriate for the evaluation of effects on reproduction from long-term, low-dose exposures; these effects may be encountered from the presence of veterinary drug residues in food. 89 FR 45663 https://www.govinfo.gov/app/details/FR-2024-05-23/2024-11313 2024-11313 fr23my24-54 4164-01-P Docket No. FDA-2000-D-0784 https://www.govinfo.gov/app/details/FR-2024-05-23/2024-11313 https://www.govinfo.gov/content/pkg/FR-2024-05-23/html/2024-11313.htm https://www.govinfo.gov/content/pkg/FR-2024-05-23/pdf/2024-11313.pdf 2 p. 45663 45664 89 FR 45663 International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1); Draft Guidance for Industry; Availability; Federal Register Vol. 89, Issue NOTICE 2024-11313 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2024-07-22 Docket No. FDA-2000-D-0784 4164-01-P 2024-11313 Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft revised guidance for industry (GFI) #115 (VICH GL22) entitled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1)." This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). In order to establish the safety of veterinary drug residues in human food, a number of toxicological evaluations are required, including the assessment of any effects on reproduction. The objective of this guidance is to ensure international harmonization of reproduction testing that is appropriate for the evaluation of effects on reproduction from long-term, low-dose exposures; these effects may be encountered from the presence of veterinary drug residues in food.

Submit either electronic or written comments on the draft guidance by July 22, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Mai Huynh, Center for Veterinary Medicine (HFV-142), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0669, Mai.Huynh@fda.hhs.gov Guidance: International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1), Mai.Huynh@fda.hhs.gov https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm https://www.fda.gov/regulatory-information/search-fda-guidance-documents https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 89, no. 101 Office of the Federal Register, National Archives and Records Administration 2024-05-23 continuing daily deposited born digital 203 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2024-05-23 P0b002ee1c74a596a 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr23my24 https://www.govinfo.gov/app/details/FR-2024-05-23 https://www.govinfo.gov/content/pkg/FR-2024-05-23/pdf/FR-2024-05-23.pdf https://www.govinfo.gov/content/pkg/FR-2024-05-23/xml/FR-2024-05-23.xml fdlp 45557 45748 DGPO 2024-05-23 2024-05-23 FR-2024-05-23 machine generated eng FR FR-2024-05-23 89 101