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HHS/FDA | RIN: 0910-AG88 | Publication ID: Spring 2015 |
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. |
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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 506E of the FDA&C Act, as amended by title X (Drug Shortages) of FDASIA, Pub. L. 112-144, July 9, 2012 |
Legal Deadline:
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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. |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: Yes | |
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. | |
RIN Data Printed in the FR: No | |
Agency Contact: Valerie Jensen Associate Director Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 22, Room 6202, Silver Spring, MD 20903 Phone:301 796-0737 |