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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>200310</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>Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Derivatives of Blood</RULE_TITLE>
        <ABSTRACT><![CDATA[FDA is proposing to amend the implementing regulation of the Prescription Drug Marketing Act of 1987, as modified by the Prescription Drug Amendments of 1992 and the FDA Modernization Act of 1997.  The final rule (12/3/99; 64 FR 67720), does not allow a registered blood establishment that provides health care services related to its activities as a blood establishment to concurrently distribute derivatives of blood.  The effective date of that rule is April 1, 2004.  FDA is amending the final rule to allow a registered blood establishment that concurrently provides health care services to also distribute derivatives of blood.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Substantive, Nonsignificant</PRIORITY_CATEGORY>
        <RIN_STATUS>First Time Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Prerule Stage</RULE_STAGE>
        <MAJOR>Undetermined</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>
            <LEGAL_DLINE_INFO>
                <DLINE_TYPE>Statutory</DLINE_TYPE>
                <DLINE_ACTION_STAGE>Other</DLINE_ACTION_STAGE>
                <DLINE_DATE>04/01/2004</DLINE_DATE>
                <DLINE_DESC>Effective date of final rule, 64 FR 67720, December 3, 1999</DLINE_DESC>
            </LEGAL_DLINE_INFO>
        </LEGAL_DLINE_LIST>
        <LEGAL_DLINE_OVERALL_DESC>Date final rule takes effect: Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures.&quot;</LEGAL_DLINE_OVERALL_DESC>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>ANPRM</TTBL_ACTION>
                <TTBL_DATE>07/00/2004</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>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>
