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HHS/FDA RIN: 0910-AG88 Publication ID: Spring 2013 
Title: Revision of Postmarketing Reporting Requirements Discontinuance or Interruption in Supply of Certain Products (Drug Shortages)  
Abstract: FDASIA amends the FD&C Act to 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. The regulation may include biological products within the notification requirements if it would benefit public health. 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed 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 506C as amended.

Action Date FR Cite
NPRM  07/00/2013   
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
Department of Health and Human Services
Food and Drug Administration
White Oak, Building 22, Room 6202, 10903 New Hampshire Avenue,
Silver Spring, MD 20903
Phone:301 796-0737

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