{"abstract":"The Food and Drug Administration (FDA or the Agency) is issuing this document to request comments relating to the development of a user fee program for biosimilar and interchangeable biological product (351(k)) applications submitted under the Public Health Service Act (PHS Act). FDA is requesting input on the identified principles for development of a 351(k) user fee program, FDA's proposed structure for a 351(k) user fee program that would adhere to these principles, and performance goals for this program. FDA plans to review the comments submitted to the docket, hold meetings with public stakeholders, and hold industry stakeholder meetings to develop proposed recommendations for a user fee program for 351(k) applications for fiscal years (FYs) 2013 through 2017.","action":"Notice; 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/2011/05/10/2011-11348.html","cfr_references":[],"citation":"76 FR 27062","comment_url":null,"comments_close_on":"2011-06-09","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments by June 9, 2011. Submit notification of interest in participating in public stakeholder meetings or industry stakeholder meetings on or before June 3, 2011.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0326"],"dockets":[],"document_number":"2011-11348","effective_on":null,"end_page":27067,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2011/05/10/2011-11348.xml","html_url":"https://www.federalregister.gov/documents/2011/05/10/2011-11348/biologics-price-competition-and-innovation-act-of-2009-options-for-a-user-fee-program-for-biosimilar","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2011-11348?publication_date=2011-05-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2011-05-10/2011-11348/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":3517,"last_updated":"2026-08-26 16:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2011-05-10/pdf/2011-11348.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2011-05-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2011/05/10/2011-11348.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-05-28T08:08:35Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":27062,"subtype":null,"title":"Biologics Price Competition and Innovation Act of 2009; Options for a User Fee Program for Biosimilar and Interchangeable Biological Product Applications for Fiscal Years 2013 Through 2017; Request for Comments","toc_doc":"Options for User Fee Program for Biosimilar and Interchangeable Biological Product Applications, etc.","toc_subject":"Biologics Price Competition and Innovation Act of 2009:","topics":[],"type":"Notice","volume":76}