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<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-04-28-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0925-AA52</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>200904</PUBLICATION_ID>
            <PUBLICATION_TITLE>Unified Agenda of Federal Regulatory and Deregulatory Actions</PUBLICATION_TITLE>
        </PUBLICATION>
        <AGENCY>
            <CODE>0925</CODE>
            <NAME>National Institutes of Health</NAME>
            <ACRONYM>NIH</ACRONYM>
        </AGENCY>
        <PARENT_AGENCY>
            <CODE>0900</CODE>
            <NAME>Department of Health and Human Services</NAME>
            <ACRONYM>HHS</ACRONYM>
        </PARENT_AGENCY>
        <RULE_TITLE>Procedures for Registration of Applicable Clinical Trials in the ClinicalTrials.gov Registry</RULE_TITLE>
        <ABSTRACT><![CDATA[NIH plans to issue new regulations that will prescribe specific procedures for registering clinical trails in the expanded ClinicalTrials.gov registry, and define the information that must be provided.  Required information will include descriptive information, recruitment information, location and contact information, and administrative information.  The regulations will define additional information needed to comply with specific statutory requirements related to search capabilities, enforcement, posting of information related to trials of uncleared/unapproved devices, as well as to support efficient entry of valid data, link the trials in the registry database to their results, and to provide a comprehensive registry of clinical trials for the public.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Substantive, Nonsignificant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously 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>Not Yet Determined</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>42 USC 282(i)</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>12/00/2009</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>Undetermined</RFA_REQUIRED>
        <SMALL_ENTITY_LIST>
            <SMALL_ENTITY>Businesses</SMALL_ENTITY>
            <SMALL_ENTITY>Organizations</SMALL_ENTITY>
        </SMALL_ENTITY_LIST>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>Undetermined</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>No</FEDERALISM>
        <ENERGY_AFFECTED>No</ENERGY_AFFECTED>
        <PRINT_PAPER>No</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>No</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Jerry</FIRST_NAME>
                <LAST_NAME>Moore</LAST_NAME>
                <TITLE>NIH Regulations Officer</TITLE>
                <AGENCY>
                    <CODE>0925</CODE>
                    <NAME>National Institutes of Health</NAME>
                    <ACRONYM>NIH</ACRONYM>
                </AGENCY>
                <PHONE>301 496-4607</PHONE>
                <FAX>301 402-0169</FAX>
                <EMAIL>jm40z@nih.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Room 601 MSC 7669, 6011 Executive Boulevard, Suite 601-K,</STREET_ADDRESS>
                    <CITY>Rockville</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20852</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
