{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with current good manufacturing practice (CGMP) for drugs, finished pharmaceuticals, including medical gases, and active pharmaceutical ingredients (APIs).","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/2021/03/03/2021-04380.html","cfr_references":[],"citation":"86 FR 12466","comment_url":null,"comments_close_on":"2021-05-03","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the collection of information by May 3, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0362"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":1,"comment_start_date":"2021-03-03","updated_at":"2023-02-28T13:06:01.822-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2011-N-0362-0011","allow_late_comments":null,"id":"FDA-2011-N-0362-0011","comment_end_date":"2021-05-04","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2011-N-0362","title":"Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals"}],"document_number":"2021-04380","effective_on":null,"end_page":12468,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/03/03/2021-04380.xml","html_url":"https://www.federalregister.gov/documents/2021/03/03/2021-04380/agency-information-collection-activities-proposed-collection-comment-request-current-good","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-04380?publication_date=2021-03-03","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-03-03/2021-04380/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":211,"last_updated":"2026-09-21 08:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-03-03/pdf/2021-04380.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-04380.pdf?1614692737","publication_date":"2021-03-03","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/03/03/2021-04380.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":1,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2011-N-0362","supporting_documents_count":0,"docket_id":"FDA-2011-N-0362","document_id":"FDA-2011-N-0362-0011","regulation_id_number":null,"title":"Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals","checked_regulationsdotgov_at":"2023-02-28T18:06:00Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":12466,"subtype":null,"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice for Manufacturing, Processing, Packing, and Holding of Finished Pharmaceuticals, Including Medical Gases, and Active Pharmaceutical Ingredients","toc_doc":"Current Good Manufacturing Practice for Manufacturing, Processing, Packing, and Holding of Finished Pharmaceuticals, Including Medical Gases, and Active Pharmaceutical Ingredients","toc_subject":"Agency Information Collection Activities; Proposals, Submissions, and Approvals:\n","topics":[],"type":"Notice","volume":86}