Rules and Regulations. Notice of availability

Agency: Food and Drug Administration, HHS
Action: Notice of availability
Citation: FR Doc. 2024-13922 · Docket No. FDA-2022-D-2899

Summary

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #276 entitled “Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs.” The guidance provides recommendations for the effectiveness evaluation of drugs indicated for the prevention of heartworm disease caused by Dirofilaria immitis in dogs. These recommendations should be read in conjunction with related Agency Veterinary International Conference on Harmonization (VICH) guidance documents and are intended to provide additional detail to elements of study design and interpretation under the recommendations laid out in the VICH guidances.

Dates

The announcement of the guidance is published in the Federal Register on June 26, 2024.

Supplementary Information

I. Background In the Federal Register of November 30, 2022 (87 FR 73560), FDA announced the availability of draft GFI #276, entitled “Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs,” giving interested persons until January 30, 2023, to comment on the draft guidance. In response to a request for an extension, the comment period was extended to May 1, 2023 (88 FR 3744). FDA received eight comment submissions on the draft guidance, some with numerous discrete comments within the submission; all comments were considered as the guidance was finalized. We clarified our discussion and recommendations related to geographic locations, laboratory dose confirmation studies, and field effectiveness studies. We also clarified that the recommendations in this guidance are based on current technology and veterinary epidemiology, including available diagnostic methodologies. Individuals are encouraged to discuss deviations from these recommendations with FDA, especially as advances in veterinary medicine related to heartworm disease, including disease epidemiology, isolate characterization, or diagnostic testing are identified. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 511 have been approved under OMB control number 0910-0117; the collections of information in 21 CFR part 514 have been approved under OMB control number 0910-0032. III. Electronic Access Persons with access to the internet may obtain the guidance at https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov . Dated: June 18, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024-13922 Filed 6-25-24; 8:45 am]