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HHS/FDA RIN: 0910-AH47 Publication ID: Spring 2017 
Title: ●Withdrawal of Regulation Requiring an Approved New Drug Applications for Drugs Sterilized by Irradiation 
Abstract:

This would remove a requirement that any drug sterilized by irradiation is considered a new drug and subject to the approval requirements of a new drug and not to be produced under an OTC monograph. FDA is proposing to take this action now because the science, data and technology of controlled nuclear radiation is better-understood. Other FDA regulations require drugs marketed pursuant to an OTC drug monograph be manufactured in compliance with current good manufacturing practices (CGMPs).

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 351    21 U.S.C. 352    21 U.S.C. 353    21 U.S.C. 355    21 U.S.C. 360    21 U.S.C. 371    21 U.S.C. 374    42 U.S.C. 264   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  03/00/2018 
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:
Kate Greenwood
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 51, Room 6286,
Silver Spring, MD 20993
Phone:204 402-1748
Email: kate.greenwood@fda.hhs.gov