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HHS/FDA RIN: 0910-AG29 Publication ID: Fall 2013 
Title: Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure 
Abstract: The regulation would amend 21 CFR 814 to require applicants who submit premarket approval applications or a supplement to an application, product development protocols, and applications for humanitarian device exemptions to include, if readily available, a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and the number of affected patients. This rule would not require additional clinical research and simply requires the applicant to briefly summarize readily available information. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 814 
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 360e; 21 USC 360e-1; 21 USC 360j; 21 USC 371 
Legal Deadline:
Action Source Description Date
Final  Statutory    12/31/2013 
Timetable:
Action Date FR Cite
NPRM  04/01/2010  75 FR 16365 
Direct Final Rule  04/01/2010  75 FR 16347 
NPRM Comment Period End  06/15/2010   
Notice of Withdrawal of Direct Final Rule  07/20/2010  75 FR 41986 
Supplemental NPRM  02/19/2013  78 FR 11612 
Final Action  01/00/2014   
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:
Paul Gadiock
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, W0-66, Room 4432,
Silver Spring, MD 20993-0002
Phone:301 796-5736
Fax:301 847-8145
Email: paul.gadiock@fda.hhs.gov

 
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