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HHS/FDA RIN: 0910-AC53 Publication ID: Fall 2016 
Title: Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements 
Abstract: The Food and Drug Administration is amending its current good manufacturing practice regulations and other regulations to clarify and strengthen requirements for the label, color, dedication, and design of medical gas containers and closures. Despite existing regulatory requirements and industry standards for medical gases, there have been repeated incidents in which cryogenic containers of harmful industrial gases have been connected to medical oxygen supply systems in hospitals and nursing homes and subsequently administered to patients. These incidents have resulted in death and serious injury. There have also been several incidents involving high-pressure medical gas cylinders that have resulted in death and injuries to patients. These amendments, together with existing regulations, are intended to ensure that the types of incidents that have occurred in the past, as well as other types of foreseeable and potentially deadly medical gas accidents, do not occur in the future. FDA has described a number of proposals in the proposed rule including requiring that gas use outlet connections on portable cryogenic medical gas containers be securely attached to the valve body. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 201.161(a)    21 CFR 211.94    21 CFR 211.125   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 351 to 21 U.S.C. 353   
Legal Deadline:  None
Action Date FR Cite
NPRM  04/10/2006  71 FR 18039   
NPRM Comment Period End  07/10/2006    
Final Action  11/00/2016 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Patrick Raulerson
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 51, Room 6368, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-3522
Fax:301 847-8440