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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>199704</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>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 proposed rule would permit an unapproved drug product to be exported under three different options. The first option would permit exportation of a drug under an approved investigational new drug application (IND). This would be consistent with the preexisting rule. The second option would permit exportation of a drug to a country other than one specified in section 802 (b)(1)(A) of the Federal Food, Drug, and Cosmetic Act, without an IND or prior FDA approval, provided that adverse event information is reported to the FDA. This would represent a significant change from the existing rule and reflects FDA's experience with drugs exported for investigational use (whereby a minute percentage of all drugs exported for investigational use result in any safety concerns). The third option would permit exportation of drugs for investigational use to one of the countries specified in Section 802(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act without an IND or prior FDA approval. This third option would implement part of the FDA Export Reform and Enhancement Act.]]></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>No</REINVENT_GOVT>
    </RIN_INFO>
</REGINFO_RIN_DATA>
