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<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-08-26-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0910-AA79</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>199904</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 Human Drugs; Labeling Requirements</RULE_TITLE>
        <ABSTRACT><![CDATA[The final rule will provide standardized format and content requirements for over-the-counter (OTC) drug product labeling, including legibility and design features for the presentation of such information as the uses for the drug, directions for use, warnings, drug interactions, active ingredients, and other information that the consumer would need to know to use the product safely and effectively.]]></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>Undetermined</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>Undetermined</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>21 CFR 201</CFR>
            <CFR>21 CFR 330</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 USC 321</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 351</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 352</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 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>
        <RPLAN_ENTRY>Yes</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>02/27/1997</TTBL_DATE>
                <FR_CITATION>62 FR 9024</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM Comment Period End</TTBL_ACTION>
                <TTBL_DATE>10/06/1997</TTBL_DATE>
                <FR_CITATION>62 FR 33379</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Reopening of Comment Period (Study B)</TTBL_ACTION>
                <TTBL_DATE>12/30/1997</TTBL_DATE>
                <FR_CITATION>62 FR 67770</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Reopening of Comment Period (Study A)</TTBL_ACTION>
                <TTBL_DATE>02/13/1998</TTBL_DATE>
                <FR_CITATION>63 FR 7331</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Final Action</TTBL_ACTION>
                <TTBL_DATE>04/00/1999</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>None</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <PRINT_PAPER>NA</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>Not Collected</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Debra</FIRST_NAME>
                <LAST_NAME>Bowen</LAST_NAME>
                <PREFIX>Dr.</PREFIX>
                <TITLE>Division of OTC Drug Evaluation</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>301 827-2222</PHONE>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>HFD-560, Center for Drug Evaluation and Research, 9200 Corporate Boulevard,</STREET_ADDRESS>
                    <CITY>Rockville</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20850</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
        <PROCUREMENT>Not Procurement Related</PROCUREMENT>
        <REINVENT_GOVT>No</REINVENT_GOVT>
    </RIN_INFO>
</REGINFO_RIN_DATA>
