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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-AA01</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>200304</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</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. 

SMALL ENTITIES AFFECTED: The effects, if any, vary depending on the individual rulemaking. However, the Agency anticipates that the rules would not have a significant economic impact on a substantial number of small entities as defined by the Regulatory Flexibility Act.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Routine and Frequent</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 350</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 360b</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 361</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 371</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <CHILD_RIN_LIST>
            <CHILD_RIN>
                <RIN>0910-AC65</RIN>
                <RULE_TITLE>Anorectal Products</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AC71</RIN>
                <RULE_TITLE>Antiemetic Products</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AC89</RIN>
                <RULE_TITLE>Antiperspirant Products</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AD31</RIN>
                <RULE_TITLE>Cough/Cold (Antihistamine) Products</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AD24</RIN>
                <RULE_TITLE>Cough/Cold (Antitussive) Products</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AD25</RIN>
                <RULE_TITLE>Cough/Cold (Combination) Products</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AD43</RIN>
                <RULE_TITLE>Cough/Cold (Nasal Decongestant) Products</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AD06</RIN>
                <RULE_TITLE>External Analgesic Products</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AD21</RIN>
                <RULE_TITLE>Ingrown Toenail Relief Products</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AD07</RIN>
                <RULE_TITLE>Internal Analgesic Products</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AD47</RIN>
                <RULE_TITLE>Labeling of Drug Products for OTC Human Use</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AD11</RIN>
                <RULE_TITLE>Nighttime Sleep Aid Products</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AC72</RIN>
                <RULE_TITLE>Ophthalmic Products</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AC98</RIN>
                <RULE_TITLE>Oral Health Care Products</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AC79</RIN>
                <RULE_TITLE>Pediculicide Products</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AD13</RIN>
                <RULE_TITLE>Salicylate (Reye&apos;s Syndrome)</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AC68</RIN>
                <RULE_TITLE>Sunscreen Products</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AD19</RIN>
                <RULE_TITLE>Vaginal Contraceptive Products</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AC93</RIN>
                <RULE_TITLE>Weight Control Products</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AC85</RIN>
                <RULE_TITLE>Laxative Drug Products</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AC82</RIN>
                <RULE_TITLE>Antidiarrheal Products</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AD33</RIN>
                <RULE_TITLE>Cough/Cold (Bronchodilator) Products</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AC96</RIN>
                <RULE_TITLE>Skin Protectant Products</RULE_TITLE>
            </CHILD_RIN>
        </CHILD_RIN_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>
        <FEDERALISM>No</FEDERALISM>
        <PRINT_PAPER>NA</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>Not Collected</INTERNATIONAL_INTEREST>
        <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>
