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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>199510</PUBLICATION_ID>
            <PUBLICATION_TITLE>The Regulatory Plan and the Unified Agenda of Federal Regulations</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 considering whether to amend its regulations on investigational new drugs to streamline requirements for exports of unapproved drugs for investigational use in other countries. FDA is considering whether to exempt, or reduce requirements for exports of such drugs to highly developed countries such as Australia, Canada, Japan, and countries that are members of the European Union or the European Free Trade Area. The proposal carries out the President's and Vice President's "National Performance Review" for drugs and devices and is consistent with recent Congressional initiatives.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Substantive, Nonsignificant</PRIORITY_CATEGORY>
        <RIN_STATUS>First Time Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Long-Term Actions</RULE_STAGE>
        <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>
