{"abstract":"The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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 Common European Medicines Agency (EMA)/FDA Application Form for Orphan Drug Medicinal Product Designation (Form FDA 3671).","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/2017/06/19/2017-12620.html","cfr_references":[],"citation":"82 FR 27836","comment_url":null,"comments_close_on":"2017-08-18","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the collection of information by August 18, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0015"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2017-06-19","updated_at":"2023-02-28T19:07:01.624-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2011-N-0015-0004","allow_late_comments":null,"id":"FDA-2011-N-0015-0004","comment_end_date":"2017-08-19","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2011-N-0015","title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs; Common EMA/FDA Application Form for Orphan Medicinal Product Designation (form FDA 3671) "}],"document_number":"2017-12620","effective_on":null,"end_page":27838,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/06/19/2017-12620.xml","html_url":"https://www.federalregister.gov/documents/2017/06/19/2017-12620/agency-information-collection-activities-proposed-collection-comment-request-orphan-drugs-common","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-12620?publication_date=2017-06-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-06-19/2017-12620/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":239,"last_updated":"2026-10-22 16:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-06-19/pdf/2017-12620.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-12620.pdf?1497617138","publication_date":"2017-06-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/06/19/2017-12620.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-2011-N-0015","supporting_documents_count":0,"docket_id":"FDA-2011-N-0015","document_id":"FDA-2011-N-0015-0004","regulation_id_number":null,"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs; Common EMA/FDA Application Form for Orphan Medicinal Product Designation (form FDA 3671) ","checked_regulationsdotgov_at":"2023-03-01T00:07:00Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":27836,"subtype":null,"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Drug Medicinal Product Designation","toc_doc":"Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Drug Medicinal Product Designation","toc_subject":"Agency Information Collection Activities; Proposals, Submissions, and Approvals:","topics":[],"type":"Notice","volume":82}