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<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-04-18-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0910-AC59</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>200904</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>Reporting Information Regarding Falsification of Data</RULE_TITLE>
        <ABSTRACT><![CDATA[The proposed rule would require sponsors to promptly report any information indicating that any person has engaged in the falsification of data in the course of proposing, designing, performing, recording, supervising, or reviewing research, or in reporting research results.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Proposed Rule Stage</RULE_STAGE>
        <MAJOR>Undetermined</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>Undetermined</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>21 CFR 16.1</CFR>
            <CFR>21 CFR 58.11 and 58.12</CFR>
            <CFR>21 CFR 71.1</CFR>
            <CFR>21 CFR 101.69 and 101.70</CFR>
            <CFR>21 CFR 170.101</CFR>
            <CFR>21 CFR 171.1</CFR>
            <CFR>21 CFR 190.6</CFR>
            <CFR>21 CFR 312.56</CFR>
            <CFR>21 CFR 511.1</CFR>
            <CFR>21 CFR 571.1</CFR>
            <CFR>21 CFR 812.46</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 USC 321</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 341 to 343</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 348 and 349</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 351 and 352</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 355</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 360b and 360c</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 360e</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 360i to 360k</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 361</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 371</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 379e</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 262</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>08/00/2009</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>No</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>No</INTERNATIONAL_INTEREST>
        <RELATED_RIN_LIST>
            <RELATED_RIN>
                <RIN>0910-AC02</RIN>
                <RIN_RELATION>Previously reported as</RIN_RELATION>
            </RELATED_RIN>
        </RELATED_RIN_LIST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Darin</FIRST_NAME>
                <LAST_NAME>Achilles</LAST_NAME>
                <TITLE>Regulatory Counsel</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>877 287-1373</PHONE>
                <FAX>301 595-1426</FAX>
                <EMAIL>ctpregulations@fda.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>14-101-11, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335,</STREET_ADDRESS>
                    <CITY>Silver Spring</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20993</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
