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<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-04-28-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0910-AG07</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>200904</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>Conditional Approval of New Animal Drugs for Minor Use and Minor Species</RULE_TITLE>
        <ABSTRACT><![CDATA[This proposed rule implements section 571 of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act).  The MUMS act added three sections to the Federal Food, Drug, and Cosmetic Act (the Act) (571, 572, and 573), and it established new regulatory procedures intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species, as well as uncommon diseases in major animal species.  Section 571 of the Act provides for animal drug conditional approval after all safety and manufacturing components of a new animal drug approval have met the standards of section 512 of the Act.  For the effectiveness component of a new animal drug review, a reasonable expectation of effectiveness must be established prior to conditional approval under section 571 of the Act.  Sponsors then have up to 5 years to complete the demonstration of effectiveness by the standards of section 512 of the Act and achieve a complete new animal drug approval.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Routine and Frequent</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Long-Term Actions</RULE_STAGE>
        <MAJOR>No</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>21 CFR 516</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 USC 360ccc</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST>
            <LEGAL_DLINE_INFO>
                <DLINE_TYPE>Statutory</DLINE_TYPE>
                <DLINE_ACTION_STAGE>NPRM</DLINE_ACTION_STAGE>
                <DLINE_DATE>02/00/2011</DLINE_DATE>
                <DLINE_DESC> </DLINE_DESC>
            </LEGAL_DLINE_INFO>
        </LEGAL_DLINE_LIST>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>04/00/2010</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>No</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>No</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>No</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Gail</FIRST_NAME>
                <LAST_NAME>Schmerfeld</LAST_NAME>
                <MIDDLE_NAME>L.</MIDDLE_NAME>
                <TITLE>Senior Regulatory Counsel</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>877 287-1373</PHONE>
                <FAX>301 595-1426</FAX>
                <EMAIL>ctpregulations@fda.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>HFV-100, Center for Tobacco Products, Document Control Center, Building 71, Room G335, 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>
