{"abstract":"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.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2024/06/26/2024-13922.html","cfr_references":[],"citation":"89 FR 53428","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on June 26, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-D-2899"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-06-26","updated_at":"2024-09-03T17:08:29.074-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-D-2899-0013","allow_late_comments":false,"id":"FDA-2022-D-2899-0013","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-D-2899","title":"Effectiveness of Anthelmintics:  Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs; Draft Guidance for Industry; Availability"}],"document_number":"2024-13922","effective_on":null,"end_page":53429,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/06/26/2024-13922.xml","html_url":"https://www.federalregister.gov/documents/2024/06/26/2024-13922/effectiveness-of-anthelmintics-specific-recommendations-for-products-proposed-for-the-prevention-of","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-13922?publication_date=2024-06-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-06-26/2024-13922/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":247,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-06-26/pdf/2024-13922.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-13922.pdf?1719319517","publication_date":"2024-06-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/06/26/2024-13922.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2022-D-2899","supporting_documents_count":0,"docket_id":"FDA-2022-D-2899","document_id":"FDA-2022-D-2899-0013","regulation_id_number":null,"title":"Effectiveness of Anthelmintics:  Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2024-06-27T13:00:26Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":53428,"subtype":null,"title":"Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs; Guidance for Industry; Availability","toc_doc":"Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":89}