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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-AF16</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>200704</PUBLICATION_ID>
            <PUBLICATION_TITLE>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>Distribution of Blood Derivatives by Registered Blood Establishments That Qualify as Health Care Entities; PDMA of 1987; PDA of 1992; Policies, Requirements, and Administrative Procedures</RULE_TITLE>
        <ABSTRACT><![CDATA[FDA is amending certain limited provisions of the implementing regulations of the Prescription Drug Marketing Act (PDMA) of 1987, as modified by the Prescription Drug Amendments (PDA) of 1992 and the FDA Modernization Act of 1997. Certain provisions of that final rule that published on December 3, 1999 (64 FR 67720), would not allow registered blood establishments or hemophilia treatment centers  that provide health care services to concurrently distribute drugs, including blood derivatives.  The effective date of those provisions of that rule is delayed until December 1, 2008, as published on November 13, 2006 (71 FR 66108)--final rule; the applicability date was delayed in order to consider comments on the proposed rule published in the Federal Register February 1, 2006 (71 FR 5200). FDA is amending the final rule to allow registered blood establishments that provide health care services related to their activities as blood establishments and certain hemophilia treatment centers to also distribute certain products, including blood derivatives.]]></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 203.3(q)</CFR>
            <CFR>21 CFR 203.22(h)</CFR>
            <CFR>21 CFR 205.3(h)</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 USC 351 to 353</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 371</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 374</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>02/01/2006</TTBL_DATE>
                <FR_CITATION>71 FR 5200</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM Comment Period End</TTBL_ACTION>
                <TTBL_DATE>05/02/2006</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Delay of Applicability</TTBL_ACTION>
                <TTBL_DATE>11/13/2006</TTBL_DATE>
                <FR_CITATION>71 FR 66108</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Final Action</TTBL_ACTION>
                <TTBL_DATE>03/00/2008</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>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Kathleen</FIRST_NAME>
                <LAST_NAME>Swisher</LAST_NAME>
                <MIDDLE_NAME>E.</MIDDLE_NAME>
                <TITLE>Regulatory Counsel</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>301 827-0372</PHONE>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N (HFM-10),</STREET_ADDRESS>
                    <CITY>Rockville</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20852</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
