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<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-05-22-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0910-AG49</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>201004</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>Disqualification of a Clinical Investigator</RULE_TITLE>
        <ABSTRACT><![CDATA[The Food and Drug Administration (FDA) is proposing to amend the regulations to extend clinical investigator disqualification to include all FDA-regulated investigational products.  Under this proposal, an investigator determined to be ineligible to receive certain investigational products such as drugs (including biologics), new animal drugs, or devices will be ineligible to receive any FDA-regulated investigational product (including but not limited to drugs, biologics, new animal drugs, devices, and food and color additives).  This proposal is based in part upon recommendations from the Government Accountability Office.  Also, this proposal harmonizes existing FDA investigator disqualification regulations and enhances transparency.  This proposal is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>First Time Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Proposed Rule Stage</RULE_STAGE>
        <MAJOR>No</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>21 CFR  16.1</CFR>
            <CFR>21 CFR  312.70</CFR>
            <CFR>21 CFR  511.1</CFR>
            <CFR>21 CFR  511.3 (new)</CFR>
            <CFR>21 CFR  812.119</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>15 USC 1451 to 1461</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 141 to 149</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>28 USC  2112</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC  201 to 262</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC  321 to 394</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC  263b to 263n</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC  467f</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC  679</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>...</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>12/00/2010</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM Comment Period End</TTBL_ACTION>
                <TTBL_DATE>03/00/2011</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>No</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>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Kathleen</FIRST_NAME>
                <LAST_NAME>Pfaender</LAST_NAME>
                <MIDDLE_NAME>E.</MIDDLE_NAME>
                <TITLE>Senior Health Policy Analyst</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>301 796-8340</PHONE>
                <FAX>301 847-8640</FAX>
                <EMAIL>kathleen.pfaender@fda.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>WO 32, Room 5129, 10903 New Hampshire Avenue,</STREET_ADDRESS>
                    <CITY>Silver Spring</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20993</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
