{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements.'' As required by the Food and Drug Administration Modernization Act of 1997 (Modernization Act), this guidance for industry describes the standards for the prompt review of efficacy supplements. It also is intended to define those efficacy supplements that are eligible for priority review.","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/1998/05/15/98-12900.html","cfr_references":[],"citation":"63 FR 27092","comment_url":null,"comments_close_on":"1998-08-13","correction_of":null,"corrections":[],"dates":"Written comments may be submitted on the guidance document by August 13, 1998. General comments on agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. 98D-0276"],"dockets":[],"document_number":"98-12900","effective_on":null,"end_page":27093,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1998/05/15/98-12900/guidance-for-industry-on-standards-for-the-prompt-review-of-efficacy-supplements-including-priority","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/98-12900?publication_date=1998-05-15","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1998-05-15/98-12900/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":62,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1998-05-15/pdf/98-12900.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1998-05-15","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1998/05/15/98-12900.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-09-21T04:41:50Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":27092,"subtype":null,"title":"Guidance for Industry on Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements; Availability","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":63}