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<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-06-09-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0910-AF43</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>201210</PUBLICATION_ID>
            <PUBLICATION_TITLE>The Regulatory Plan and the 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>Over-the-Counter (OTC) Drug Review--Sunscreen Products</RULE_TITLE>
        <ABSTRACT><![CDATA[The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded.  After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first of the future actions will address the safety of sunscreen active ingredients. The second of the future actions will address active ingredients reviewed under time and extent applications.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Prerule Stage</RULE_STAGE>
        <MAJOR>No</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>21 CFR 201</CFR>
            <CFR>21 CFR 310</CFR>
            <CFR>21 CFR 330 to 358</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 USC 321p</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 331</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 351 to 353</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 355</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 360</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 371</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>ANPRM (Sunscreen and Insect Repellent)</TTBL_ACTION>
                <TTBL_DATE>02/22/2007</TTBL_DATE>
                <FR_CITATION>72 FR 7941</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>ANPRM Comment Period End</TTBL_ACTION>
                <TTBL_DATE>05/23/2007</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM (UVA/UVB)</TTBL_ACTION>
                <TTBL_DATE>08/27/2007</TTBL_DATE>
                <FR_CITATION>72 FR 49070</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM Comment Period End</TTBL_ACTION>
                <TTBL_DATE>12/26/2007</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Final Action (UVA/UVB)</TTBL_ACTION>
                <TTBL_DATE>06/17/2011</TTBL_DATE>
                <FR_CITATION>76 FR 35620</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM (Effectiveness)</TTBL_ACTION>
                <TTBL_DATE>06/17/2011</TTBL_DATE>
                <FR_CITATION>76 FR 35672</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM (Effectiveness) Comment Period End </TTBL_ACTION>
                <TTBL_DATE>09/15/2011</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>ANPRM (Dosage Forms)</TTBL_ACTION>
                <TTBL_DATE>06/17/2011</TTBL_DATE>
                <FR_CITATION>76 FR 35669</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>ANPRM (Dosage Forms) Comment Period End</TTBL_ACTION>
                <TTBL_DATE>09/15/2011</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>ANPRM (Safety)</TTBL_ACTION>
                <TTBL_DATE>07/00/2013</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM (Time and Extent Applications)</TTBL_ACTION>
                <TTBL_DATE>09/00/2013</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>Yes</RFA_REQUIRED>
        <SMALL_ENTITY_LIST>
            <SMALL_ENTITY>Businesses</SMALL_ENTITY>
        </SMALL_ENTITY_LIST>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>Local</GOVT_LEVEL>
            <GOVT_LEVEL>State</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>Yes</FEDERALISM>
        <PRINT_PAPER>Yes</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>No</INTERNATIONAL_INTEREST>
        <RELATED_RIN_LIST>
            <RELATED_RIN>
                <RIN>0910-AA01</RIN>
                <RIN_RELATION>Split from</RIN_RELATION>
            </RELATED_RIN>
        </RELATED_RIN_LIST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>David</FIRST_NAME>
                <LAST_NAME>Eng</LAST_NAME>
                <TITLE>Regulatory Project Manager</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>301 796-2773</PHONE>
                <FAX>301 796-9899</FAX>
                <EMAIL>david.eng@fda.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Center for Drug Evaluation and Research, WO 22, Room 5487, 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>
