{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Contract Manufacturing Arrangements for Drugs: Quality Agreements.\" This guidance describes our current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy.","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/2013/05/28/2013-12539.html","cfr_references":[],"citation":"78 FR 31943","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 29, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-0558"],"dockets":[],"document_number":"2013-12539","effective_on":null,"end_page":31944,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/05/28/2013-12539.xml","html_url":"https://www.federalregister.gov/documents/2013/05/28/2013-12539/draft-guidance-for-industry-on-contract-manufacturing-arrangements-for-drugs-quality-agreements","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-12539?publication_date=2013-05-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-05-28/2013-12539/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":2524,"last_updated":"2026-07-26 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-05-28/pdf/2013-12539.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-12539.pdf?1369400083","publication_date":"2013-05-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/05/28/2013-12539.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-D-0558","supporting_documents_count":0,"docket_id":"FDA-2013-D-0558","regulation_id_number":null,"title":"Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements; Availability","checked_regulationsdotgov_at":"2013-06-18T05:01:29Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":31943,"subtype":null,"title":"Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements; Availability","toc_doc":"Contract Manufacturing Arrangements for Drugs; Quality Agreements","toc_subject":"Draft Guidance for Industry; Availability:","topics":[],"type":"Notice","volume":78}