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    <RIN_INFO>
        <RIN>0906-AA73</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>200904</PUBLICATION_ID>
            <PUBLICATION_TITLE>Unified Agenda of Federal Regulatory and Deregulatory Actions</PUBLICATION_TITLE>
        </PUBLICATION>
        <AGENCY>
            <CODE>0906</CODE>
            <NAME>Health Resources and Services Administration</NAME>
            <ACRONYM>HRSA</ACRONYM>
        </AGENCY>
        <PARENT_AGENCY>
            <CODE>0900</CODE>
            <NAME>Department of Health and Human Services</NAME>
            <ACRONYM>HHS</ACRONYM>
        </PARENT_AGENCY>
        <RULE_TITLE>Add Vascularized Composite Allografts to the Definition of Organs Covered by the Rule Governing the Operation of the Organ Procurement and Transplantation Network (OPTN)</RULE_TITLE>
        <ABSTRACT><![CDATA[The Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation (DOT) plans to issue a notice of proposed rulemaking to include vascularized composite allografts (VCA) to the definition of organs for purpose of coverage under NOTA and the OPTN final rule. NOTA authorizes the Secretary to include, by regulation, additional organs under the definition of organ.  Currently, the OPTN final rule defines covered organs as a human kidney, liver, heart, lung, or pancreas, or intestine (including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract). VCA transplantation comprises transplants of a variety of body parts (i.e. hand and face transplants) that are not currently regulated and which share common characteristics.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Proposed Rule Stage</RULE_STAGE>
        <MAJOR>No</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>42 CFR 121</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>sec 301 of the National Organ Transplant Act (NOTA) of 1984, as amended</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>sec 371 to 376 of the Public Health Service Act</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>sec 1138 of the Social Security Act</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>12/00/2009</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>No</RFA_REQUIRED>
        <SMALL_ENTITY_LIST>
            <SMALL_ENTITY>No</SMALL_ENTITY>
        </SMALL_ENTITY_LIST>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>None</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>No</FEDERALISM>
        <PRINT_PAPER>No</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>No</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Elizabeth</FIRST_NAME>
                <LAST_NAME>Ortiz-Rios</LAST_NAME>
                <PREFIX>Dr.</PREFIX>
                <TITLE>Medical Officer</TITLE>
                <AGENCY>
                    <CODE>0906</CODE>
                    <NAME>Health Resources and Services Administration</NAME>
                    <ACRONYM>HRSA</ACRONYM>
                </AGENCY>
                <PHONE>301 443-4423</PHONE>
                <FAX>301 584-6095</FAX>
                <EMAIL>eortiz-rios@hrsa.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Room 12C-06, 5600 Fishers Lane,</STREET_ADDRESS>
                    <CITY>Rockville</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20857</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
