{"abstract":"The Food and Drug Administration (FDA) published a proposed rule in the Federal Register of April 1, 2010, along with a companion direct final rule. The proposed rule proposed to amend the regulations on premarket approval of medical devices to include requirements relating to the submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat, diagnose, or cure. The Agency received significant adverse comment and withdrew the direct final rule. The Agency is issuing this supplemental notice of proposed rulemaking re-proposing the amendments reflecting comments received.","action":"Supplemental notice of proposed rulemaking.","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/2013/02/19/2013-03647.html","cfr_references":[{"chapter":null,"citation_url":null,"part":814,"title":21}],"citation":"78 FR 11612","comment_url":null,"comments_close_on":"2013-04-22","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by April 22, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by March 21, 2013, (see the \"Paperwork Reduction Act of 1995\" section of this document).","disposition_notes":null,"docket_ids":["Docket No. FDA-2009-N-0458"],"dockets":[],"document_number":"2013-03647","effective_on":null,"end_page":11617,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/02/19/2013-03647.xml","html_url":"https://www.federalregister.gov/documents/2013/02/19/2013-03647/medical-devices-pediatric-uses-of-devices-requirement-for-submission-of-information-on-pediatric","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-03647?publication_date=2013-02-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-02-19/2013-03647/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":1884,"last_updated":"2026-07-25 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-02-19/pdf/2013-03647.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-03647.pdf?1360936464","publication_date":"2013-02-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/02/19/2013-03647.txt","regulation_id_number_info":{"0910-AG29":{"issue":"201310","html_url":"https://www.federalregister.gov/regulations/0910-AG29/requirement-for-submission-of-information-on-pediatric-subpopulations-that-suffer-from-a-disease-or-","title":"Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201310&RIN=0910-AG29&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AG29"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Tab A - \"Draft Regulatory Action, April 1, 2010\" - [OMB Review, Executive Order12866, RPMS Note to the Division of Docket Management, April 19, 2010\" - (Medical Device; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From","document_id":"FDA-2009-N-0458-0004"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AG29/requirement-for-submission-of-information-on-pediatric-subpopulations-that-suffer-from-a-disease-or-","title":"Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure"},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2009-N-0458","supporting_documents_count":1,"docket_id":"FDA-2009-N-0458","regulation_id_number":"0910-AG29","title":"Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations that Suffer from a Disease or Condition that a Device is Intended to Treat, Diagnose, or Cure-CLOSED","checked_regulationsdotgov_at":"2013-05-18T05:01:12Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":11612,"subtype":null,"title":"Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure","toc_doc":"Requirement for Submission of Information on Pediatric Subpopulations that Suffer from a Disease or Condition that a Device is Intended to Treat, Diagnose, or Cure","toc_subject":"Medical Devices; Pediatric Uses of Devices:","topics":["Administrative practice and procedure","Confidential business information","Medical devices","Medical research","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":78}