{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to implement 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 (the FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). This final rule implements portions of Title XI of the MMA that pertain to provision of notice to each patent owner and the new drug application (NDA) holder of certain patent certifications made by applicants submitting 505(b)(2) applications or ANDAs; the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; submission of amendments and supplements to 505(b)(2) applications and ANDAs; and the types of bioavailability and bioequivalence data that can be used to support these applications. This final rule also amends certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act.","action":"Final rule.","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/2016/10/06/2016-22690.html","cfr_references":[{"chapter":null,"citation_url":null,"part":314,"title":21},{"chapter":null,"citation_url":null,"part":320,"title":21}],"citation":"81 FR 69580","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective December 5, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0830"],"dockets":[],"document_number":"2016-22690","effective_on":"2016-12-05","end_page":69658,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/10/06/2016-22690.xml","html_url":"https://www.federalregister.gov/documents/2016/10/06/2016-22690/abbreviated-new-drug-applications-and-505b2-applications","images":{"ER06OC16.003":{"large":"https://img.federalregister.gov/ER06OC16.003/ER06OC16.003_large.png","original_size":"https://img.federalregister.gov/ER06OC16.003/ER06OC16.003_original_size.png"},"ER06OC16.002":{"large":"https://img.federalregister.gov/ER06OC16.002/ER06OC16.002_large.png","original_size":"https://img.federalregister.gov/ER06OC16.002/ER06OC16.002_original_size.png"},"ER06OC16.005":{"large":"https://img.federalregister.gov/ER06OC16.005/ER06OC16.005_large.png","original_size":"https://img.federalregister.gov/ER06OC16.005/ER06OC16.005_original_size.png"},"ER06OC16.004":{"large":"https://img.federalregister.gov/ER06OC16.004/ER06OC16.004_large.png","original_size":"https://img.federalregister.gov/ER06OC16.004/ER06OC16.004_original_size.png"},"ER06OC16.001":{"large":"https://img.federalregister.gov/ER06OC16.001/ER06OC16.001_large.png","original_size":"https://img.federalregister.gov/ER06OC16.001/ER06OC16.001_original_size.png"},"ER06OC16.000":{"large":"https://img.federalregister.gov/ER06OC16.000/ER06OC16.000_large.png","original_size":"https://img.federalregister.gov/ER06OC16.000/ER06OC16.000_original_size.png"}},"images_metadata":{"ER06OC16.003":{"large":{"identifier":"ER06OC16.003","content_type":"image/png","size":139054,"width":822,"sha":"76d10e76fb6226c8a5733496a103fa3c","url":"https://img.federalregister.gov/ER06OC16.003/ER06OC16.003_large.png","height":976},"original_size":{"identifier":"ER06OC16.003","content_type":"image/png","size":323270,"width":3623,"sha":"985aba7232b75d2e6f0500e110967d60","url":"https://img.federalregister.gov/ER06OC16.003/ER06OC16.003_original_size.png","height":4304}},"ER06OC16.002":{"large":{"identifier":"ER06OC16.002","content_type":"image/png","size":168827,"width":823,"sha":"55b7177de809c6e2cd0a28cfc7f52cf2","url":"https://img.federalregister.gov/ER06OC16.002/ER06OC16.002_large.png","height":1080},"original_size":{"identifier":"ER06OC16.002","content_type":"image/png","size":297540,"width":3093,"sha":"8fb75641973e8d27e968950715997e83","url":"https://img.federalregister.gov/ER06OC16.002/ER06OC16.002_original_size.png","height":4057}},"ER06OC16.005":{"large":{"identifier":"ER06OC16.005","content_type":"image/png","size":128750,"width":823,"sha":"2e389874f21bd5626e1d93dfa7810a93","url":"https://img.federalregister.gov/ER06OC16.005/ER06OC16.005_large.png","height":915},"original_size":{"identifier":"ER06OC16.005","content_type":"image/png","size":280356,"width":3479,"sha":"f7321b7c51e1c795a3f0720db7a65e84","url":"https://img.federalregister.gov/ER06OC16.005/ER06OC16.005_original_size.png","height":3867}},"ER06OC16.004":{"large":{"identifier":"ER06OC16.004","content_type":"image/png","size":132181,"width":823,"sha":"c761326650e53046cad442f0771caa13","url":"https://img.federalregister.gov/ER06OC16.004/ER06OC16.004_large.png","height":965},"original_size":{"identifier":"ER06OC16.004","content_type":"image/png","size":283692,"width":3381,"sha":"848c0a51a33232ae277ef182cd4c9fea","url":"https://img.federalregister.gov/ER06OC16.004/ER06OC16.004_original_size.png","height":3965}},"ER06OC16.001":{"large":{"identifier":"ER06OC16.001","content_type":"image/png","size":152674,"width":823,"sha":"b4d4592fb8ac12ba1dafd58c6375ed85","url":"https://img.federalregister.gov/ER06OC16.001/ER06OC16.001_large.png","height":1081},"original_size":{"identifier":"ER06OC16.001","content_type":"image/png","size":265769,"width":3057,"sha":"55a77fbda2c43a72e7a5543ce3f75cec","url":"https://img.federalregister.gov/ER06OC16.001/ER06OC16.001_original_size.png","height":4017}},"ER06OC16.000":{"large":{"identifier":"ER06OC16.000","content_type":"image/png","size":163414,"width":823,"sha":"92b2794e9b1fe181b74a923c2484d027","url":"https://img.federalregister.gov/ER06OC16.000/ER06OC16.000_large.png","height":1102},"original_size":{"identifier":"ER06OC16.000","content_type":"image/png","size":306269,"width":3241,"sha":"3486a4e136dee1c974ca872d92377d7b","url":"https://img.federalregister.gov/ER06OC16.000/ER06OC16.000_original_size.png","height":4338}}},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-22690?publication_date=2016-10-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-10-06/2016-22690/mods.xml","not_received_for_publication":null,"page_length":79,"page_views":{"count":19617,"last_updated":"2026-09-21 22:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-10-06/pdf/2016-22690.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-22690.pdf?1475671523","publication_date":"2016-10-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/10/06/2016-22690.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. 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"}],"regulatory_plan":{"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)"},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2011-N-0830","supporting_documents_count":9,"docket_id":"FDA-2011-N-0830","regulation_id_number":"0910-AF97","title":"Abbreviated New Drug Applications and 505(b)(2) Applications","checked_regulationsdotgov_at":"2016-10-26T06:00:17Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":69580,"subtype":null,"title":"Abbreviated New Drug Applications and 505(b)(2) Applications","toc_doc":"Abbreviated New Drug Applications and 505(b)(2) Applications","toc_subject":null,"topics":["Administrative practice and procedure","Confidential business information","Drugs","Reporting and recordkeeping requirements"],"type":"Rule","volume":81}