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<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-09-23-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0906-AA32</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>199804</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>Organ Procurement and Transplantation Network Rules</RULE_TITLE>
        <ABSTRACT><![CDATA[Section 1138 of the Social Security Act requires Medicare and Medicaid participating hospitals that perform organ transplants to be members of and abide by the rules and requirements of the Organ Procurement and Transplantation Network (OPTN) as established by section 372 of the Public Health Service Act. Section 1138 also requires that for organ procurement costs attributable to payments to an Organ Procurement Organization (OPO) to be paid by Medicare or Medicaid, the OPO must be a member of and abide by the rules and requirements of the OPTN. No other entity (for example, a histocompatibility laboratory) is required to be a member of or abide by the rules of the OPTN under the provisions of the statute. It is the Department's position that no rule, requirement, policy, or other issuance of the OPTN will be considered to be a "rule or requirement" of the Network within the meaning of section 1138 unless the Secretary has formally approved that rule. The OPTN is currently in operation and these rules will impose no further cost.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Final Rule Stage</RULE_STAGE>
        <MAJOR>Yes</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>42 USC 1320b-8 sec 1138 of the Social Security Act</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 274 sec 372 of the Public Health Service Act</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 274b sec 374 of the Public Health Service Act</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 216 sec 215 of the Public Health Service Act</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <RPLAN_ENTRY>Yes</RPLAN_ENTRY>
        <RPLAN_INFO>
            <STMT_OF_NEED><![CDATA[These regulations are needed to establish a legally binding framework for the operation of the OPTN and for participation in the OPTN by transplant hospitals and OPOs.]]></STMT_OF_NEED>
            <LEGAL_BASIS><![CDATA[Section 215 of the Public Health Service Act, along with the provision of sections 372 and 374 of the Act (42 USC 216, 274 and 274, respectively) provide authority to issue OPTN regulations. In addition section 1138 of the Social Security Act (42 USC 1320b-8) requires Medicare and Medicaid participating hospitals that perform organ transplants to be members of and abide by the rules and requirements of the Organ Procurement and Transplantation Network (OPTN) as established by section 372 of the Public Health Service Act (42 USC 274).]]></LEGAL_BASIS>
            <ALTERNATIVES><![CDATA[The alternative was to continue without codifying existing policies.]]></ALTERNATIVES>
            <COSTS_AND_BENEFITS><![CDATA[There are no anticipated costs beyond the cost of preparing the regulations (approximately $100,000.00). The anticipated benefit is that the regulations will make mandatory adherence to the policies set forth in the regulations.]]></COSTS_AND_BENEFITS>
            <RISKS><![CDATA[None known.]]></RISKS>
        </RPLAN_INFO>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>09/08/1994</TTBL_DATE>
                <FR_CITATION>59 FR 46482</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM Comment Period End</TTBL_ACTION>
                <TTBL_DATE>12/07/1994</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Final with Comment Period</TTBL_ACTION>
                <TTBL_DATE>04/02/1998</TTBL_DATE>
                <FR_CITATION>63 FR 16296</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Comment Period End</TTBL_ACTION>
                <TTBL_DATE>06/01/1998</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <ADDITIONAL_INFO>Previously reported under RIN 0905-AD26. ^PSections 215, 372, and 374 of the PHS Act provide general authority to regulate the activities of the Organ Procurement and Transplantation Network (OPTN) established under section 372.</ADDITIONAL_INFO>
        <RFA_REQUIRED>No</RFA_REQUIRED>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>None</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <PRINT_PAPER>NA</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>Not Collected</INTERNATIONAL_INTEREST>
        <PROCUREMENT>Not Procurement Related</PROCUREMENT>
        <REINVENT_GOVT>No</REINVENT_GOVT>
    </RIN_INFO>
</REGINFO_RIN_DATA>
