<?xml version="1.0" encoding="UTF-8" standalone="yes"?>
<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-04-12-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0910-AF43</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>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 action addresses active ingredients reviewed under Time and Extent Applications.  The second action addresses other effectiveness issues for OTC sunscreen drug products.  The third action finalizes sunscreen formulation, labeling, and testing requirements for both ultraviolet B and ultraviolet A radiation protection.  The last action addresses combination products containing sunscreen and insect repellent ingredients.]]></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>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>NPRM (Time and Extent Applications)</TTBL_ACTION>
                <TTBL_DATE>07/00/2010</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM (Effectiveness)</TTBL_ACTION>
                <TTBL_DATE>10/00/2010</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Final Action (UVA/UVB)</TTBL_ACTION>
                <TTBL_DATE>10/00/2010</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM (Sunscreen and Insect Repellent)</TTBL_ACTION>
                <TTBL_DATE>To Be Determined</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>Walter</FIRST_NAME>
                <LAST_NAME>Ellenberg</LAST_NAME>
                <MIDDLE_NAME>J.</MIDDLE_NAME>
                <TITLE>Regulatory Project Management Officer</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>301 796-2090</PHONE>
                <FAX>301 796-9899</FAX>
                <EMAIL>walter.ellenberg@fda.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Center for Drug Evaluation and Research, WO-22, Room 5488, 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>
