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<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-06-09-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0910-AC53</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>200410</PUBLICATION_ID>
            <PUBLICATION_TITLE>The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions</PUBLICATION_TITLE>
        </PUBLICATION>
        <AGENCY>
            <CODE>0910</CODE>
            <NAME>Food and Drug Administration</NAME>
            <ACRONYM>FDA</ACRONYM>
        </AGENCY>
        <PARENT_AGENCY>
            <CODE>0900</CODE>
            <NAME>Department of Health and Human Services</NAME>
            <ACRONYM>HHS</ACRONYM>
        </PARENT_AGENCY>
        <RULE_TITLE>Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements</RULE_TITLE>
        <ABSTRACT><![CDATA[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.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Substantive, Nonsignificant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Proposed Rule Stage</RULE_STAGE>
        <MAJOR>Undetermined</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>21 CFR 201.161(a)</CFR>
            <CFR>21 CFR 210.3(b)</CFR>
            <CFR>21 CFR 211.94</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 USC 321</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 351</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 353</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>06/00/2005</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>Undetermined</RFA_REQUIRED>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>None</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>No</FEDERALISM>
        <PRINT_PAPER>NA</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>Not Collected</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Elaine</FIRST_NAME>
                <LAST_NAME>Tseng</LAST_NAME>
                <MIDDLE_NAME>H.</MIDDLE_NAME>
                <TITLE>Office of Regulatory Policy</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>301 594-2041</PHONE>
                <FAX>301 827-5562</FAX>
                <EMAIL>elaine.tseng@fda.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7),</STREET_ADDRESS>
                    <CITY>Rockville</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20852</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
