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HHS/FDA RIN: 0910-AH96 Publication ID: Fall 2022 
Title: Updated Regulations for Medical Gases 
Abstract:

FDA intends to revise its regulations with regard to medical gases. These changes are anticipated to include, but are not necessarily limited to, specific changes to current good manufacturing practice (cGMP), labeling, and postmarket reporting regulations applicable to medical gases, generally aiming for less stringent regulation where appropriate.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: Pub. L. 115-31, sec. 756 (2017 Consolidated Appropriations Act)    secs. 501, 502, 505, 512, 575, 576, and 701(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 355, 360b, 360ddd, 360ddd-1, and 371(a)).   
Legal Deadline:
Action Source Description Date
Final  Statutory  Statute enacted in May 2017 with July 2017 final rule deadline  07/15/2017 

Overall Description of Deadline: Section 756 of the 2017 Consolidated Appropriations Act (Pub. L. 115-31) directed FDA to issue final regulations revising the Federal drug regulations with respect to medical gases by July 2017.

Timetable:
Action Date FR Cite
NPRM  05/23/2022  87 FR 31302   
NPRM Comment Period End  08/22/2022 
Final Rule  10/00/2024 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
David Faranda
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-8767
Email: david.faranda@fda.hhs.gov