{"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 collection of information, including 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 individual patient expanded access applications.","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/2018/11/07/2018-24321.html","cfr_references":[],"citation":"83 FR 55723","comment_url":null,"comments_close_on":"2019-01-07","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the collection of information by January 7, 2019.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-3758"],"dockets":[{"supporting_documents":[{"title":"Attachment 2 - Form Instructions re: Agency Information Collection Activities; Proposed Collection; Comment Request; Individual Patient Expanded Access Applications: Form FDA 3926","document_id":"FDA-2018-N-3758-0004"},{"title":"Attachment 1 - Form FDA 3926 – Individual Patient Expanded Access, Investigational New Drug Application (IND) re: Agency Information Collection Activities; Proposed Collection; Comment Request; Individual Patient Expanded Access Applications: Form FDA 392","document_id":"FDA-2018-N-3758-0003"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-11-07","updated_at":"2023-02-28T21:13:14.947-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-N-3758-0001","allow_late_comments":null,"id":"FDA-2018-N-3758-0001","comment_end_date":"2019-01-08","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":2,"id":"FDA-2018-N-3758","title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Individual Patient Expanded Access Applications"}],"document_number":"2018-24321","effective_on":null,"end_page":55726,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/11/07/2018-24321.xml","html_url":"https://www.federalregister.gov/documents/2018/11/07/2018-24321/agency-information-collection-activities-proposed-collection-comment-request-individual-patient","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-24321?publication_date=2018-11-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-11-07/2018-24321/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":415,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-11-07/pdf/2018-24321.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-24321.pdf?1541511934","publication_date":"2018-11-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/11/07/2018-24321.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Attachment 2 - Form Instructions re: Agency Information Collection Activities; Proposed Collection; Comment Request; Individual Patient Expanded Access Applications: Form FDA 3926","document_id":"FDA-2018-N-3758-0004"},{"title":"Attachment 1 - Form FDA 3926 – Individual Patient Expanded Access, Investigational New Drug Application (IND) re: Agency Information Collection Activities; Proposed Collection; Comment Request; Individual Patient Expanded Access Applications: Form FDA 392","document_id":"FDA-2018-N-3758-0003"}],"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-2018-N-3758","supporting_documents_count":2,"docket_id":"FDA-2018-N-3758","document_id":"FDA-2018-N-3758-0001","regulation_id_number":null,"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Individual Patient Expanded Access Applications","checked_regulationsdotgov_at":"2023-03-01T02:13:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":55723,"subtype":null,"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Individual Patient Expanded Access Applications: Form FDA 3926","toc_doc":"Individual Patient Expanded Access Applications","toc_subject":"Agency Information Collection Activities; Proposals, Submissions, and Approvals:","topics":[],"type":"Notice","volume":83}