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HHS/FDA RIN: 0910-AB34 Publication ID: Fall 2008 
Title: Applications for FDA Approval To Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications 
Abstract: The rule amends the regulations on marketing approval of new drugs to discontinue the use of approvable and not approvable letters when taking action on a marketing application and instead use complete response letters. The rule also amends the regulations on extension of the review clock because of amendments to applications. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 312    21 CFR 314   
Legal Authority: 21 USC 321    21 USC 331    21 USC 351 to 353    21 USC 355    21 USC 371    21 USC 374    21 USC 379e   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  07/20/2004  69 FR 43357   
NPRM Comment Period End  10/18/2004    
Final Action  07/10/2008  73 FR 39588   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Brian L. Pendleton
Senior Policy Advisor
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Office of Policy, WO 32, Room 4250, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-4614
Fax:301 847-3541
Email: brian.pendleton@fda.hhs.gov