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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-AF97</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>201304</PUBLICATION_ID>
            <PUBLICATION_TITLE>Update to the 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>Abbreviated New Drug Applications and 505(b)(2) Applications</RULE_TITLE>
        <ABSTRACT><![CDATA[This proposed rule would make changes to certain procedures for Abbreviated New Drug Applications and 505(b)(2) applications relating to patent certifications, provision of notice to patent owners and application holders, the availability of a 30-month stay of approval, amendments and supplements and the types of bioavailability and bioequivalence data that can be used to support these applications.]]></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>Undetermined</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>21 CFR 314.3</CFR>
            <CFR>21 CFR 314.50</CFR>
            <CFR>21 CFR 314.52</CFR>
            <CFR>21 CFR 314.53</CFR>
            <CFR>21 CFR 314.54</CFR>
            <CFR>21 CFR 314.60</CFR>
            <CFR>21 CFR 314.70</CFR>
            <CFR>21 CFR 314.90</CFR>
            <CFR>21 CFR 314.93</CFR>
            <CFR>21 CFR 314.94</CFR>
            <CFR>21 CFR 314.95</CFR>
            <CFR>21 CFR 314.96</CFR>
            <CFR>21 CFR 314.97</CFR>
            <CFR>21 CFR 314.99</CFR>
            <CFR>21 CFR 314.101</CFR>
            <CFR>21 CFR 314.105</CFR>
            <CFR>21 CFR 314.107</CFR>
            <CFR>21 CFR 314.108</CFR>
            <CFR>21 CFR 314.125</CFR>
            <CFR>21 CFR 314.127</CFR>
            <CFR>21 CFR 320.1</CFR>
            <CFR>21 CFR 320.23</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>PL 108-173, title XI</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 355</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</TTBL_ACTION>
                <TTBL_DATE>07/00/2013</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>Undetermined</RFA_REQUIRED>
        <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>Janice</FIRST_NAME>
                <LAST_NAME>Weiner</LAST_NAME>
                <MIDDLE_NAME>L.</MIDDLE_NAME>
                <TITLE>Principal Regulatory Counsel</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>301 796-3475</PHONE>
                <FAX>301 847-8440</FAX>
                <EMAIL>janice.weiner@fda.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6270,</STREET_ADDRESS>
                    <CITY>Silver Spring</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20993-0002</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
