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HHS/FDA RIN: 0910-AC48 Publication ID: Fall 2003 
Title: Applications for FDA Approval To Market a New Drug: Patent Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications 
Abstract: The final rule would clarify the types of patents for which information must or must not be submitted to FDA. The final rule would also revise the patent declaration to make it more detailed. The rule would also revise the regulations regarding the approval date for certain abbreviated new drug applications or "505(b)(2) applications" by stating that there is only one opportunity for a 30-month stay in the approval date of an ANDA or 505(b)(2) application. 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: Yes  Unfunded Mandates: Private Sector 
CFR Citation: 21 CFR 314.52(a)(3)    21 CFR 314.53(b)    21 CFR 314.53(c)(1)    21 CFR 314.53(c)(2)    21 CFR 314.95(a)(3)   
Legal Authority: 21 USC 321    21 USC 331    21 USC 351 to 353    21 USC 355    21 USC 355a    21 USC 356    21 USC 356a    21 USC 356b    21 USC 356c    21 USC 371    21 USC 374    21 USC 379e   
Legal Deadline:  None
Action Date FR Cite
NPRM  10/24/2002  67 FR 65448   
NPRM Comment Period End  12/23/2002    
Final Rule  06/18/2003  68 FR 36676   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Jarilyn Dupont
Director of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
WO Building 32, Room 4245, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-4830
Fax:301 847-3541

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