{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled \"Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs.\" The purpose of this guidance is to provide recommendations for how requestors can comply with the requirements described in the Proposed Administrative Order (OTC000038) titled Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs (hereinafter referred to as C001).","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/2025/06/05/2025-10251.html","cfr_references":[],"citation":"90 FR 23942","comment_url":null,"comments_close_on":"2025-10-03","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by October 3, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2025-D-1358"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2025-06-05T09:57:10.828-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-D-1358-0001","allow_late_comments":false,"id":"FDA-2025-D-1358-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-D-1358","title":"Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs; Draft Guidance for Industry; Availability"}],"document_number":"2025-10251","effective_on":null,"end_page":23943,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/06/05/2025-10251.xml","html_url":"https://www.federalregister.gov/documents/2025/06/05/2025-10251/recommendations-for-complying-with-over-the-counter-monograph-procedure-for-minor-changes-c001-minor","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-10251?publication_date=2025-06-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-06-05/2025-10251/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":251,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-05/pdf/2025-10251.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-10251.pdf?1749041114","publication_date":"2025-06-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/06/05/2025-10251.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-2025-D-1358","supporting_documents_count":0,"docket_id":"FDA-2025-D-1358","document_id":"FDA-2025-D-1358-0001","regulation_id_number":null,"title":"Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2025-06-06T16:55:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":23942,"subtype":null,"title":"Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs; Draft Guidance for Industry; Availability","toc_doc":"Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}