{"abstract":"The Food and Drug Administration (FDA) is establishing a public docket to collect comments related to the post-marketing pediatric-focused safety reviews of products posted between October 12, 2018, and April 1, 2019, on FDA's website but not presented at the April 8, 2019, Pediatric Advisory Committee (PAC) meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public.","action":"Notice, establishment of a public docket; request for comments.","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/2019/04/02/2019-06385.html","cfr_references":[],"citation":"84 FR 12623","comment_url":null,"comments_close_on":"2019-04-15","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments by April 15, 2019.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-N-1215"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2019-04-02","updated_at":"2023-02-28T14:24:39.683-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2019-N-1215-0001","allow_late_comments":null,"id":"FDA-2019-N-1215-0001","comment_end_date":"2019-04-16","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2019-N-1215","title":"Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket; Request for Comments"}],"document_number":"2019-06385","effective_on":null,"end_page":12624,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/04/02/2019-06385.xml","html_url":"https://www.federalregister.gov/documents/2019/04/02/2019-06385/post-marketing-pediatric-focused-product-safety-reviews-establishment-of-a-public-docket-request-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-06385?publication_date=2019-04-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-04-02/2019-06385/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":264,"last_updated":"2026-07-26 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-04-02/pdf/2019-06385.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-06385.pdf?1554122726","publication_date":"2019-04-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/04/02/2019-06385.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-2019-N-1215","supporting_documents_count":0,"docket_id":"FDA-2019-N-1215","document_id":"FDA-2019-N-1215-0001","regulation_id_number":null,"title":"Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket; Request for Comments","checked_regulationsdotgov_at":"2023-02-28T19:24:38Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":12623,"subtype":null,"title":"Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket; Request for Comments","toc_doc":"Post-Marketing Pediatric-Focused Product Safety Reviews","toc_subject":"Establishment of a Public Docket:","topics":[],"type":"Notice","volume":84}