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HHS/FDA RIN: 0910-AG88 Publication ID: Spring 2014 
Title: Revision of Postmarketing Reporting Requirements Discontinuance or Interruption in Supply of Certain Products (Drug Shortages)  
Abstract: This rule would require manufacturers of certain drug products to report discontinuances or interruptions in the manufacturing of these products 6 months prior to the discontinuance or interruption, or if that is not possible, as soon as practicable. Manufacturers must notify FDA of a discontinuance or interruption in the manufacture of drugs that are life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition. 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 21 CFR 314.81; 21 CFR 314.91 
Legal Authority: secs 506c, 506c-1, 506d, and 506f of the FDA&C Act, as amended by title X (Drug Shortages) of FDASIA, PL 112-144, July 9, 2012  
Legal Deadline:
Action Source Description Date
NPRM  Statutory  Not later than 18 months after the date of enactment of FDASIA, FDA must adopt the final regulation implementing section 506C as amended.  01/09/2014 

Overall Description of Deadline: Section 1001 of FDASIA states that not later than 18 months after the date of enactment of FDASIA, the Secretary shall adopt a final regulation implementing section 506(c) as amended.

Timetable:
Action Date FR Cite
NPRM  11/04/2013  78 FR 65904 
NPRM Comment Period End  01/03/2014   
Final Action  01/00/2015   
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Valerie Jensen
Associate Director, CDER Drug Shortage Staff
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO Building 22, Room 6202, 10903 New Hampshire Avenue,
Silver Spring, MD 20903
Phone:301 796-0737

 
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