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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-AF65</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>200610</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>Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation</RULE_TITLE>
        <ABSTRACT><![CDATA[FDA and Health Resources and Services Administration (HRSA) issued a direct final rule and companion proposed rule to amend the regulations to consider as part of an organ (and regulated by HRSA) those blood vessels recovered with vascularized human organs that are intended for use in organ transplantation; and to exclude such blood vessels from the definition of human cells, tissues, and cellular and tissue-based products (regulated by FDA).  We took this action to provide that blood vessels recovered with organs and intended for use in organ transplantation will be governed by the regulations pertaining to organs.  We believe this change will eliminate unnecessary burden resulting from an organ procurement organizations efforts to comply with both FDA and HRSA requirements with respect to blood vessels (FDA jurisdiction) and organs (HRSA jurisdiction).  We received significant adverse comments in response to the direct final rule.  Therefore, the direct final rule is being withdrawn.  FDA and HRSA intend to finalize the proposed rule after considering comments.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Substantive, Nonsignificant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Final Rule Stage</RULE_STAGE>
        <MAJOR>No</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>21 CFR 1271</CFR>
            <CFR>42 CFR 121</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>42 USC 216</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 243</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 263a</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 264</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 271</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 273 to 274d</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 1302</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 1306</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM - Companion to Direct Final Rule</TTBL_ACTION>
                <TTBL_DATE>05/12/2006</TTBL_DATE>
                <FR_CITATION>71 FR 27649</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Direct Final Rule</TTBL_ACTION>
                <TTBL_DATE>05/12/2006</TTBL_DATE>
                <FR_CITATION>71 FR 27606</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Comment Period End</TTBL_ACTION>
                <TTBL_DATE>07/26/2006</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Direct Final Rule-Withdrawal</TTBL_ACTION>
                <TTBL_DATE>09/14/2006</TTBL_DATE>
                <FR_CITATION>71 FR 54198</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Final Action</TTBL_ACTION>
                <TTBL_DATE>09/00/2007</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>No</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>
        <RELATED_AGENCY_LIST>
            <RELATED_AGENCY>
                <AGENCY>
                    <CODE>0906</CODE>
                    <NAME>Health Resources and Services Administration</NAME>
                    <ACRONYM>HRSA</ACRONYM>
                </AGENCY>
                <AGENCY_RELATION>Joint</AGENCY_RELATION>
            </RELATED_AGENCY>
        </RELATED_AGENCY_LIST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Denise</FIRST_NAME>
                <LAST_NAME>Sanchez</LAST_NAME>
                <TITLE>Regulatory Policy Analyst</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>301 827-6210</PHONE>
                <FAX>301 827-9434</FAX>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Center for Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike,</STREET_ADDRESS>
                    <CITY>Rockville</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20852-1448</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
