{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).","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/2021/06/11/2021-12265.html","cfr_references":[],"citation":"86 FR 31318","comment_url":null,"comments_close_on":"2021-07-12","correction_of":null,"corrections":[],"dates":"Submit written comments (including recommendations) on the collection of information by July 12, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-N-1261"],"dockets":[{"supporting_documents":[{"title":"Reference 10 Tanur 1992 RE Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Disclosures to Healthcare Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug","document_id":"FDA-2020-N-1261-0011"},{"title":"Ref 9 Ozuru et al 2013 RE Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Disclosures to Healthcare Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug","document_id":"FDA-2020-N-1261-0010"},{"title":"Ref 8 Fox et al 2020 RE Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Disclosures to Healthcare Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug","document_id":"FDA-2020-N-1261-0009"},{"title":"Ref 7 Schaeffer Presser 2003 RE Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Disclosures to Healthcare Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug","document_id":"FDA-2020-N-1261-0008"},{"title":"Ref 6 Kesselheim et al 2012 RE Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Disclosures to Healthcare Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug","document_id":"FDA-2020-N-1261-0007"},{"title":"Ref 4 Murshid Mohaidin 2017 RE Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Disclosures to Healthcare Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug","document_id":"FDA-2020-N-1261-0006"},{"title":"Reference 3 Ajzen 1985 RE Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Disclosures to Healthcare Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug","document_id":"FDA-2020-N-1261-0005"}],"agency_name":"FDA","documents":[{"comment_count":1,"comment_start_date":"2021-06-11","updated_at":"2023-02-28T20:23:54.126-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-N-1261-0004","allow_late_comments":null,"id":"FDA-2020-N-1261-0004","comment_end_date":"2021-07-13","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":7,"id":"FDA-2020-N-1261","title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Study of Disclosures to Health Care Providers Regarding Data that Do Not Support Unapproved Use of an Approved Prescription Drug"}],"document_number":"2021-12265","effective_on":null,"end_page":31323,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/06/11/2021-12265.xml","html_url":"https://www.federalregister.gov/documents/2021/06/11/2021-12265/agency-information-collection-activities-submission-for-office-of-management-and-budget-review","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-12265?publication_date=2021-06-11","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-06-11/2021-12265/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":250,"last_updated":"2026-04-27 10:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-06-11/pdf/2021-12265.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-12265.pdf?1623329129","publication_date":"2021-06-11","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/06/11/2021-12265.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 10 Tanur 1992 RE Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Disclosures to Healthcare Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug","document_id":"FDA-2020-N-1261-0011"},{"title":"Ref 9 Ozuru et al 2013 RE Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Disclosures to Healthcare Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug","document_id":"FDA-2020-N-1261-0010"},{"title":"Ref 8 Fox et al 2020 RE Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Disclosures to Healthcare Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug","document_id":"FDA-2020-N-1261-0009"},{"title":"Ref 7 Schaeffer Presser 2003 RE Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Disclosures to Healthcare Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug","document_id":"FDA-2020-N-1261-0008"},{"title":"Ref 6 Kesselheim et al 2012 RE Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Disclosures to Healthcare Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug","document_id":"FDA-2020-N-1261-0007"},{"title":"Ref 4 Murshid Mohaidin 2017 RE Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Disclosures to Healthcare Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug","document_id":"FDA-2020-N-1261-0006"},{"title":"Reference 3 Ajzen 1985 RE Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Disclosures to Healthcare Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug","document_id":"FDA-2020-N-1261-0005"}],"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-2020-N-1261","supporting_documents_count":7,"docket_id":"FDA-2020-N-1261","document_id":"FDA-2020-N-1261-0004","regulation_id_number":null,"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Study of Disclosures to Health Care Providers Regarding Data that Do Not Support Unapproved Use of an Approved Prescription Drug","checked_regulationsdotgov_at":"2023-03-01T01:23:53Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":31318,"subtype":null,"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Disclosures to Healthcare Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug","toc_doc":"Study of Disclosures to Healthcare Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug","toc_subject":"Agency Information Collection Activities; Proposals, Submissions, and Approvals:\n","topics":[],"type":"Notice","volume":86}