{"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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on \"Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification [510(k)] Submissions.\"","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/2013/03/18/2013-06128.html","cfr_references":[],"citation":"78 FR 16676","comment_url":null,"comments_close_on":"2013-05-17","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the collection of information by May 17, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2010-D-0194"],"dockets":[],"document_number":"2013-06128","effective_on":null,"end_page":16678,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/03/18/2013-06128.xml","html_url":"https://www.federalregister.gov/documents/2013/03/18/2013-06128/agency-information-collection-activities-proposed-collection-comment-request-draft-guidance-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-06128?publication_date=2013-03-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-03-18/2013-06128/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":150,"last_updated":"2026-08-25 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-03-18/pdf/2013-06128.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-06128.pdf?1363352018","publication_date":"2013-03-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/03/18/2013-06128.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-2010-D-0194","supporting_documents_count":0,"docket_id":"FDA-2010-D-0194","regulation_id_number":null,"title":"Draft Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion Pump – Premarket Notification (510(k)) Submissions; Availability","checked_regulationsdotgov_at":"2013-05-18T05:02:48Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":16676,"subtype":null,"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion Pump-Premarket Notification [510(k)] Submissions","toc_doc":"Draft Guidance for Industry and FDA Staff; Total Product Life Cycle, Infusion Pump  Premarket Notification Submissions","toc_subject":"Agency Information Collection Activities; Proposals, Submissions, and Approvals:","topics":[],"type":"Notice","volume":78}