This script search US Code. View Rule
Menu Item - Home
Menu Item - Agenda Main page
Menu Item - Historical Agenda
Menu Item - Historical Agenda
Menu Item - Agenda Search
Menu Item - EO Dashboard
Menu Item - Reg Review
Menu Item - EO Agency lists
Menu Item - EO Search
Menu Item - EO Historical Reports
Menu Item - Review Counts
Menu Item - OIRA Letters
Menu Item - EOM 12866 Search
Menu Item - EO XML Reports
Menu Item - ICR Dashboard page
Menu Item - ICR Main page
Menu Item - ICR Search
Menu Item - ICR XML Reports
Menu Item - FAQ
Menu Item - Additional Resources
Menu Item - Contact Us
Search: Agenda Reg Review ICR
       Search

View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

HHS/FDA RIN: 0910-AC53 Publication ID: Fall 2006 
Title: Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements 
Abstract: The Food and Drug Administration is proposing to amend 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 proposed 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 mixups, do not occur in the future. 
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 USC 321; 21 USC 351 to 21 USC 353 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  04/10/2006  71 FR 18039 
NPRM Comment Period End  07/10/2006   
Final Action  04/00/2007   
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
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
Email: patrick.raulerson@fda.hhs.gov

 
About Us   Vertical Spacer Spacer Related Resources   Vertical Spacer Spacer Disclosure   Vertical Spacer Spacer Accessibility   Vertical Spacer Spacer Privacy Policy   Vertical Spacer Spacer Contact Us