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HHS/FDA RIN: 0910-AG19 Publication ID: Spring 2009 
Title: ●Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs 
Abstract: The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that FDA publish a list of all authorized generic drugs identified in an annual report since 1999, and that the agency update the list quarterly. The final rule would, among other things, require submission of a copy of the portion of annual reports containing the authorized generic information identified in FDAAA to a central office in FDA that compiles and updates the list, to permit easier identification of the information. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 314.3(b)    21 CFR 314.81(b)(2)(ii)(b)   
Legal Authority: 21 USC 355(t)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  09/29/2008  73 FR 56529   
NPRM Comment Period End  12/15/2008    
Final Action  07/00/2009    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Michelle Bernstein
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, Bldg. 51, Room 6362, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002
Phone:301 796-3469
Fax:301 847-8440
Email: michelle.bernstein-doses@fda.hhs.gov