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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-AF33</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>200704</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--Cough/Cold (Combination) 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.  This action addresses combination products containing an oral bronchodilator.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Routine and Frequent</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 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 351 to 353</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 355</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 360a</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 371a</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 331</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>NPRM (Amendment)</TTBL_ACTION>
                <TTBL_DATE>07/13/2005</TTBL_DATE>
                <FR_CITATION>70 FR 40232</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Final Action (Technical Amendment)</TTBL_ACTION>
                <TTBL_DATE>04/00/2007</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Final Action</TTBL_ACTION>
                <TTBL_DATE>06/00/2007</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>NA</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>Not Collected</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>Gerald</FIRST_NAME>
                <LAST_NAME>Rachanow</LAST_NAME>
                <MIDDLE_NAME>M.</MIDDLE_NAME>
                <TITLE>Regulatory Counsel, Division of Over-the-Counter Drug Products</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>301 827-2241</PHONE>
                <FAX>301 827-2315</FAX>
                <EMAIL>gerald.rachanow@fda.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>HFD-560, Center for Drug Evaluation and Research (HFD-560), 5600 Fishers Lane,</STREET_ADDRESS>
                    <CITY>Rockville</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20857</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
