{"abstract":"The Food and Drug Administration (FDA) is extending the comment period for the proposed rule that appeared in the Federal Register of February 6, 2015. In the proposed rule, FDA requested comments on its proposal to implement portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which amended provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). FDA also requested comment on its proposal to amend certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.","action":"Proposed rule; extension of comment period.","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/2015/04/24/2015-09523.html","cfr_references":[{"chapter":null,"citation_url":null,"part":314,"title":21},{"chapter":null,"citation_url":null,"part":320,"title":21}],"citation":"80 FR 22953","comment_url":null,"comments_close_on":"2015-02-06","correction_of":null,"corrections":[],"dates":"FDA is extending the comment period on the proposed rule published February 6, 2015 (80 FR 6802). Submit either electronic or written comments on the proposed rule by June 8, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0830"],"dockets":[{"supporting_documents":[{"title":"Reference 2-5 - U.S. Department of Health & Human Services, “Guidance on Proper Consideration of Small Entities in Rulemakings of the U.S. Department of Health and Human Services,” May 2003 re Abbreviated New Drug Applications and 505(b)(2) Applications","document_id":"FDA-2011-N-0830-0028"},{"title":"Reference 2-4 - U.S. Dept of Commerce, Bureau of the Census, Economic Census, Manuf Summary Series. General Summary Industry Stats for Subsectors and Industries by Employment Size 2007 re Abbreviated New Drug Applications and 505(b)(2) Applications","document_id":"FDA-2011-N-0830-0027"},{"title":"Reference 2-3 - U.S. Dept of Commerce, Bureau of the Census, Economic Census Manuf Summary Series. General Summary Industry Stats for Subsectors and Industries by Employment Size 2012 re Abbreviated New Drug Applications and 505(b)(2) Applications","document_id":"FDA-2011-N-0830-0026"},{"title":"Reference 2-2 - Bureau of Labor Statistics (BLS). 2016. May 2015 National Industry-Specific Occupational Employment and Wage Estimates for NAICS 325400 - Pharmal and Medicine Manufacturing","document_id":"FDA-2011-N-0830-0025"},{"title":"Reference 2 -1 - Final Regulatory Impact Analysis, Final Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act Analysis for ANDAs and 505(b)(2) Apps; Final Rule re Abbreviated New Drug Applications and 505(b)(2) Applications","document_id":"FDA-2011-N-0830-0024"},{"title":"Reference 1 - Federal Trade Commission, Report on “Generic Drug Entry Prior to Patent Expiration  An FTC Study” (July 2002) re Abbreviated New Drug Applications and 505(b)(2) Applications","document_id":"FDA-2011-N-0830-0023"},{"title":"Reference 2 - Pharmaceutical Preparation Manufacturing 2002, Economic Census Manufacturing Industry Series re Abbreviated New Drug Applications and 505(b)(2) Applications","document_id":"FDA-2011-N-0830-0004"},{"title":"Reference 1 - ANDAs and 505(b)(2) Applications Docket No. FDA-2011-N-0830 Preliminary Regulatory Impact Analysis Initial Regulatory Flexibility Analysis Unfunded Mandates Reform Act Analysis re Abbreviated New Drug Applications and 505(b)(2) Applications","document_id":"FDA-2011-N-0830-0003"},{"title":"List of References re Abbreviated New Drug Applications and 505(b)(2) Applications","document_id":"FDA-2011-N-0830-0002"}],"agency_name":"FDA","documents":[{"comment_count":12,"comment_start_date":"2015-04-24","updated_at":"2023-02-28T20:10:38.469-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2011-N-0830-0008","allow_late_comments":null,"id":"FDA-2011-N-0830-0008","comment_end_date":"2015-06-09","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":9,"id":"FDA-2011-N-0830","title":"Abbreviated New Drug Applications and 505(b)(2) Applications"}],"document_number":"2015-09523","effective_on":null,"end_page":22954,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/04/24/2015-09523.xml","html_url":"https://www.federalregister.gov/documents/2015/04/24/2015-09523/abbreviated-new-drug-applications-and-505b2-applications-extension-of-comment-period","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-09523?publication_date=2015-04-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-04-24/2015-09523/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":699,"last_updated":"2026-10-24 02:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-04-24/pdf/2015-09523.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-09523.pdf?1429793157","publication_date":"2015-04-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/04/24/2015-09523.txt","regulation_id_number_info":{"0910-AF97":{"issue":"201604","html_url":"https://www.federalregister.gov/regulations/0910-AF97/abbreviated-new-drug-applications-and-505-b-2-","title":"Abbreviated New Drug Applications and 505(b)(2)","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201604&RIN=0910-AF97&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AF97"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 2-5 - U.S. Department of Health & Human Services, “Guidance on Proper Consideration of Small Entities in Rulemakings of the U.S. Department of Health and Human Services,” May 2003 re Abbreviated New Drug Applications and 505(b)(2) Applications","document_id":"FDA-2011-N-0830-0028"},{"title":"Reference 2-4 - U.S. Dept of Commerce, Bureau of the Census, Economic Census, Manuf Summary Series. 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