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<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-09-22-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0910-AA61</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>199610</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>Export Requirements for Drugs for Investigational Use in Other Countries</RULE_TITLE>
        <ABSTRACT><![CDATA[FDA is proposing to amend its regulations on investigational new drug products to streamline requirements for exports of unapproved drugs for investigational use to foreign countries. The proposal would permit an unapproved new drug product to be exported without prior FDA approval if the product is to be exported for use in a clinical investigation in any country. Persons exporting such products to countries not on the list of 25 countries in the recent Export Reform Act would be required to report to FDA at the time of export. Thus, the proposal would eliminate the need to submit a written request to FDA and to obtain FDA approval before exporting an unapproved new drug product for use in a clinical investigation in a foreign country. The proposal is relevant to the President's and Vice-President's "National Performance Review" for drugs and is consistent with recent Congressional initiatives.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Substantive, Nonsignificant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Long-Term Actions</RULE_STAGE>
        <MAJOR>No</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>21 CFR 312.110</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 USC 331</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 351 to 352</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 355 to 357</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 360</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 360b</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 360aa to 360dd</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 371 to 372</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 374</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 379e</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 379g</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 381 to 382</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 393</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 216</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 241</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 242l</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>To Be Determined</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <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>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Linda</FIRST_NAME>
                <LAST_NAME>Horton</LAST_NAME>
                <TITLE>Director, International Policy Staff, Office of Policy (HF-23)</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>301 827-3344</PHONE>
                <EMAIL>lhorton@bangate.fda.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>5600 Fishers Lane,</STREET_ADDRESS>
                    <CITY>Rockville</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20857</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
        <REINVENT_GOVT>Revising Text to Reduce Burden or Duplication, or Streamline Requirements</REINVENT_GOVT>
    </RIN_INFO>
</REGINFO_RIN_DATA>
