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<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-05-19-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0910-AG18</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>Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products</RULE_TITLE>
        <ABSTRACT><![CDATA[This rule would require electronic package inserts for human drug and biological prescription products with limited exceptions, in lieu of paper, which is currently used.  These inserts contain prescribing information intended for healthcare practitioners.  This would ensure that the information accompanying the product is the most up-to-date information regarding important safety and efficacy issues about these products.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Economically Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Proposed Rule Stage</RULE_STAGE>
        <MAJOR>Yes</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>Private Sector</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>21 CFR 201.100</CFR>
            <CFR>21 CFR 201.306</CFR>
            <CFR>21 CFR 201.310</CFR>
            <CFR>21 CFR 606.121</CFR>
            <CFR>21 CFR 606.122</CFR>
            <CFR>21 CFR 610.60</CFR>
            <CFR>21 CFR 610.61</CFR>
            <CFR>...</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 USC 321</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 331</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 358</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 360</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 360b</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 360gg to 360ss</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 371</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 374</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 379e</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 216</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 241</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 262</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 264</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>10/00/2013</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <ADDITIONAL_INFO>Includes Retrospective Review under E.O. 13563.</ADDITIONAL_INFO>
        <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>
        <ENERGY_AFFECTED>No</ENERGY_AFFECTED>
        <PRINT_PAPER>Yes</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>No</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Lauren</FIRST_NAME>
                <LAST_NAME>Milner</LAST_NAME>
                <TITLE>Regulatory Policy Advisor</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>301 796-5114</PHONE>
                <EMAIL>lauren.milner@fda.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Office of Clinical Policy, 10903 New Hampshire Avenue, WO 32, Room 5103,</STREET_ADDRESS>
                    <CITY>Silver Spring</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20993-0002</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
