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HHS/FDA RIN: 0910-AF97 Publication ID: Spring 2008 
Title: Proposed Revisions To Implement Portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and Other Changes 
Abstract: Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173) (MMA) amended provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that govern the approval of new drug applications (NDAs) described by section 505(b)(2) of the act (505(b)(2) applications) and abbreviated new drug applications (ANDAs) described by section 505(j) of the act. This proposed rule would implement portions of title XI of the MMA that pertain to: (1) Provision of notice to each patent owner and the NDA holder of certain patent certifications made by applicants submitting 505(b)(2) applications or ANDAs; (2) the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; (3) submission of amendments and supplements to 505(b)(2) applications and ANDAs; and (4) the types of bioavailability and bioequivalence data that can be used to support these applications. This proposed rule also would amend certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the act. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 314.3; 21 CFR 314.50; 21 CFR 314.52; 21 CFR 314.53; 21 CFR 314.60; 21 CFR 314.70; 21 CFR 314.90; 21 CFR 314.94; 21 CFR 314.95; 21 CFR 314.96; 21 CFR 314.97; 21 CFR 314.99; 21 CFR 314.101; 21 CFR 314.105; 21 CFR 314.107; 21 CFR 314.108; 21 CFR 314.125; 21 CFR 314.127; 21 CFR 320.1; 21 CFR 320.23 
Legal Authority: PL 108-173, title XI; 21 USC 355; 21 USC 371 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  04/00/2009   
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Janice L. Weiner
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 51, Room 6268, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-3601
Fax:301 847-8440
Email: janice.weiner@fda.hhs.gov

 
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