{"abstract":"The Food and Drug Administration (FDA or Agency) 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 information collection associated with the Agency's Biosimilars User Fee Program.","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/2021/09/17/2021-20060.html","cfr_references":[],"citation":"86 FR 51900","comment_url":null,"comments_close_on":"2021-11-16","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the collection of information by November 16, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-1967"],"dockets":[{"supporting_documents":[{"title":"Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals","document_id":"FDA-2018-N-1967-0006"},{"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review;\nComment Request; Biosimilars User Fee Program","document_id":"FDA-2018-N-1967-0005"},{"title":"Agency Information Collection\nActivities; Proposed Collection;\nComment Request; Biosimilars User\nFee Program","document_id":"FDA-2018-N-1967-0004"},{"title":"Agency Information Collection Activities; Announcement of Office of\nManagement and Budget Approvals","document_id":"FDA-2018-N-1967-0003"},{"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biosimilars User Fee Program","document_id":"FDA-2018-N-1967-0002"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Program","document_id":"FDA-2018-N-1967-0001"}],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2021-09-17","updated_at":"2023-02-28T12:45:44.274-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-N-1967-0004","allow_late_comments":null,"id":"FDA-2018-N-1967-0004","comment_end_date":"2021-11-17","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":6,"id":"FDA-2018-N-1967","title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Program"}],"document_number":"2021-20060","effective_on":null,"end_page":51902,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/09/17/2021-20060.xml","html_url":"https://www.federalregister.gov/documents/2021/09/17/2021-20060/agency-information-collection-activities-proposed-collection-comment-request-biosimilars-user-fee","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-20060?publication_date=2021-09-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-09-17/2021-20060/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":216,"last_updated":"2026-08-25 18:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-09-17/pdf/2021-20060.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-20060.pdf?1631796327","publication_date":"2021-09-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/09/17/2021-20060.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals","document_id":"FDA-2018-N-1967-0006"},{"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review;\nComment Request; Biosimilars User Fee Program","document_id":"FDA-2018-N-1967-0005"},{"title":"Agency Information Collection\nActivities; Proposed Collection;\nComment Request; Biosimilars User\nFee Program","document_id":"FDA-2018-N-1967-0004"},{"title":"Agency Information Collection Activities; Announcement of Office of\nManagement and Budget Approvals","document_id":"FDA-2018-N-1967-0003"},{"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biosimilars User Fee Program","document_id":"FDA-2018-N-1967-0002"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Program","document_id":"FDA-2018-N-1967-0001"}],"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-1967","supporting_documents_count":6,"docket_id":"FDA-2018-N-1967","document_id":"FDA-2018-N-1967-0004","regulation_id_number":null,"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Program","checked_regulationsdotgov_at":"2023-02-28T17:45:43Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":51900,"subtype":null,"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Program","toc_doc":"Biosimilars User Fee Program","toc_subject":"Agency Information Collection Activities; Proposals, Submissions, and Approvals:\n","topics":[],"type":"Notice","volume":86}