{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled \"Draft Guidance for Industry and Food and Drug Administration Staff: Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act.\" FDA is issuing this guidance document to describe how to compile and submit the readily available pediatric use information required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance is not final nor is it in effect at this time.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human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/2013/02/19/2013-03652.html","cfr_references":[],"citation":"78 FR 11654","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 22, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by April 22, 2013, (see the \"Paperwork Reduction Act of 1995\" section of this document).","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-0117"],"dockets":[],"document_number":"2013-03652","effective_on":null,"end_page":11655,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/02/19/2013-03652.xml","html_url":"https://www.federalregister.gov/documents/2013/02/19/2013-03652/draft-guidance-for-industry-and-food-and-drug-administration-staff-providing-information-about","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-03652?publication_date=2013-02-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-02-19/2013-03652/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":156,"last_updated":"2026-07-28 08:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-02-19/pdf/2013-03652.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-03652.pdf?1360936473","publication_date":"2013-02-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/02/19/2013-03652.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-D-0117","supporting_documents_count":0,"docket_id":"FDA-2013-D-0117","regulation_id_number":null,"title":"Providing Information about Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act","checked_regulationsdotgov_at":"2013-04-24T05:00:26Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":11654,"subtype":null,"title":"Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act; Availability","toc_doc":"Providing Information About Pediatric Uses of Medical Devices under the Federal Food, Drug, and Cosmetic Act","toc_subject":"Draft Guidance for Industry and Staff; Availability:","topics":[],"type":"Notice","volume":78}