{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled \"Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.\" FDA is issuing this draft guidance as mandated under the Food and Drug Omnibus Reform Act of 2022 (FDORA) which requires that FDA update or issue guidance relating to the format and content of Diversity Action Plans required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by FDORA. This guidance describes the format and content of Diversity Action Plans, including the timing and process for submitting such plans by application or notification type. In addition, this draft guidance describes the criteria and process by which FDA will evaluate sponsors' requests for waivers from the FD&C Act. Because FDA is required by statute to specify the form and manner for the submission of Diversity Action Plans in guidance, insofar as this draft guidance specifies the form and manner for submission of Diversity Action Plans, when this guidance is finalized, it will have binding effect.","action":"Notice of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/2024/06/28/2024-14284.html","cfr_references":[],"citation":"89 FR 54010","comment_url":null,"comments_close_on":"2024-09-26","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by September 26, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-D-0789"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-06-28","updated_at":"2024-09-03T17:09:11.827-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-D-0789-0110","allow_late_comments":false,"id":"FDA-2021-D-0789-0110","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2021-D-0789","title":"Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability"}],"document_number":"2024-14284","effective_on":null,"end_page":54012,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/06/28/2024-14284.xml","html_url":"https://www.federalregister.gov/documents/2024/06/28/2024-14284/diversity-action-plans-to-improve-enrollment-of-participants-from-underrepresented-populations-in","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-14284?publication_date=2024-06-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-06-28/2024-14284/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":8678,"last_updated":"2026-05-08 10:15:09 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-06-28/pdf/2024-14284.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-14284.pdf?1719492337","publication_date":"2024-06-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/06/28/2024-14284.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-2021-D-0789","supporting_documents_count":0,"docket_id":"FDA-2021-D-0789","document_id":"FDA-2021-D-0789-0110","regulation_id_number":null,"title":"Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2024-06-29T14:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":54010,"subtype":null,"title":"Diversity Action Plans To Improve Enrollment of Participants From Underrepresented Populations in Clinical Studies; Draft Guidance for Industry; Availability","toc_doc":"Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":89}