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    <RIN_INFO>
        <RIN>0910-AG74</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>201404</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>Use of Certain Symbols in Labeling</RULE_TITLE>
        <ABSTRACT><![CDATA[The purpose of this rule is to allow for the inclusion of certain stand-alone symbols contained in a standard that FDA recognizes, provided that such symbols are explained in a symbols glossary that contemporaneously accompanies the medical device.  The rule also revises prescription device labeling regulations to authorize the use of the symbol statement "Rx only" on the labeling of prescription devices.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Final Rule Stage</RULE_STAGE>
        <MAJOR>No</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>21 CFR 660.2</CFR>
            <CFR>21 CFR 660.28</CFR>
            <CFR>21 CFR 660.35</CFR>
            <CFR>21 CFR 660.45</CFR>
            <CFR>21 CFR 660.55</CFR>
            <CFR>21 CFR 801.15(c)(1)</CFR>
            <CFR>21 CFR 801.109</CFR>
            <CFR>21 CFR 809.3</CFR>
            <CFR>21 CFR 809.10</CFR>
            <CFR>...</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>sec 502(c) of the Food Drug and Cosmetic Act (FD&amp;C Act), 21 USC 352(c)</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>sec 514(c) of FD&amp;C Act, 21 USC 360d(c), enacted by the Food and Drug Modernization Act of 1997 (FDAMA)</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>04/19/2013</TTBL_DATE>
                <FR_CITATION>78 FR 23508</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM Comment Period End</TTBL_ACTION>
                <TTBL_DATE>06/18/2013</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Final Action</TTBL_ACTION>
                <TTBL_DATE>08/00/2014</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <ADDITIONAL_INFO>Includes Retrospective Review under E.O. 13563 with small business burden reduction.</ADDITIONAL_INFO>
        <RFA_REQUIRED>No</RFA_REQUIRED>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>None</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>No</FEDERALISM>
        <ENERGY_AFFECTED>Yes</ENERGY_AFFECTED>
        <PRINT_PAPER>No</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>Yes</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Mary</FIRST_NAME>
                <LAST_NAME>Brady</LAST_NAME>
                <MIDDLE_NAME>W.</MIDDLE_NAME>
                <TITLE>Senior Policy Analyst</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>301 796-6089</PHONE>
                <EMAIL>mary.brady@fda.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Center for Devices and Radiological Health, WO66, Room 5426, 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>
