{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Collection of Race and Ethnicity Data in Clinical Trials for FDA Regulated Products.\" This draft guidance recommends a standardized approach for collecting race and ethnicity information in clinical trials conducted in the United States and abroad for certain FDA regulated products. The standardized approach being recommended was developed by the Office of Management and Budget (OMB).","action":"Notice.","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/2003/01/30/03-2162.html","cfr_references":[],"citation":"68 FR 4788","comment_url":null,"comments_close_on":"2003-03-31","correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on the draft guidance by March 31, 2003. General comments on agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. 02D-0018"],"dockets":[],"document_number":"03-2162","effective_on":null,"end_page":4789,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2003/01/30/03-2162.xml","html_url":"https://www.federalregister.gov/documents/2003/01/30/03-2162/draft-guidance-for-industry-on-the-collection-of-race-and-ethnicity-data-in-clinical-trials-for-fda","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/03-2162?publication_date=2003-01-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2003-01-30/03-2162/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":92,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2003-01-30/pdf/03-2162.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2003-01-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2003/01/30/03-2162.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":4788,"subtype":null,"title":"Draft Guidance for Industry on the Collection of Race and Ethnicity Data in Clinical Trials for FDA Regulated Products; Availability","toc_doc":"Race and ethnicity data collection in clinical trials for FDA regulated products","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":68}