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    <RIN_INFO>
        <RIN>0925-AA55</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>201410</PUBLICATION_ID>
            <PUBLICATION_TITLE>The Regulatory Plan and the 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>Clinical Trials Registration and Results Submission</RULE_TITLE>
        <ABSTRACT><![CDATA[This proposed rule would prescribe procedures for registering and submitting summary results, including adverse events, of clinical trials in ClinicalTrials.gov, in accordance with section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA, Pub. L. 110-85).  As previously announced, NIH intends to proceed with a single rulemaking to implement the expanded registry, results reporting, and adverse event information reporting requirements of the statute.]]></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>No</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>42 CFR 3</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>42 USC 282(i)</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 282(j)</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>5 USC 301</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 286(a)</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 241(a)</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 216(b)</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST>
            <LEGAL_DLINE_INFO>
                <DLINE_TYPE>Statutory</DLINE_TYPE>
                <DLINE_ACTION_STAGE>Final</DLINE_ACTION_STAGE>
                <DLINE_DATE>09/27/2010</DLINE_DATE>
                <DLINE_DESC> </DLINE_DESC>
            </LEGAL_DLINE_INFO>
        </LEGAL_DLINE_LIST>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>12/00/2014</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>Undetermined</RFA_REQUIRED>
        <SMALL_ENTITY_LIST>
            <SMALL_ENTITY>Businesses</SMALL_ENTITY>
        </SMALL_ENTITY_LIST>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>None</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>
