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HHS/FDA RIN: 0910-AF97 Publication ID: Spring 2007 
Title: ●Proposed Revisions to 21 CFR Parts 314 and 320 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 (Public Law 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. These provisions are those: 1) That require applicants to notify drug sponsors who have patents listed in the FDA Orange Book of the application; 2) that apply to the period of delay (a 30-month stay) before approval of certain applications; 3) that control the submission of amendments and supplements to certain applications, and, 4) define 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: First time 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 314.94    21 CFR 314.95    21 CFR 314.96    21 CFR 314.97    21 CFR 314.101    21 CFR 314.105    21 CFR 314.107    21 CFR 314.108    21 CFR 320.1    21 CFR 320.23   
Legal Authority: PL 108-173, title XI    21 USC 355    21 USC 371   
Legal Deadline:  None
Action Date FR Cite
NPRM  03/00/2008    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: 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, Building 51, Room 6268, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-3601
Fax:301 847-8440

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