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<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-07-26-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0938-AV90</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>202510</PUBLICATION_ID>
            <PUBLICATION_TITLE>The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions</PUBLICATION_TITLE>
        </PUBLICATION>
        <AGENCY>
            <CODE>0938</CODE>
            <NAME>Centers for Medicare &amp; Medicaid Services</NAME>
            <ACRONYM>CMS</ACRONYM>
        </AGENCY>
        <PARENT_AGENCY>
            <CODE>0900</CODE>
            <NAME>Department of Health and Human Services</NAME>
            <ACRONYM>HHS</ACRONYM>
        </PARENT_AGENCY>
        <RULE_TITLE>Medicare Drug Price Negotiation Program (CMS-4215)</RULE_TITLE>
        <ABSTRACT><![CDATA[<!DOCTYPE html>
<html>
<head>
</head>
<body>
<p>This proposed rule would codify the Medicare Drug Price Negotiation Program established in the Inflation Reduction Act. These changes would apply to the Negotiation Program effective initial price applicability year 2029.</p>
</body>
</html>]]></ABSTRACT>
        <PRIORITY_CATEGORY>Economically Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>First Time Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Proposed Rule Stage</RULE_STAGE>
        <MAJOR>Yes</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <EO_13771_DESIGNATION>Other</EO_13771_DESIGNATION>
        <RFA_SECTION_610_REVIEW>Section 610 Review</RFA_SECTION_610_REVIEW>
        <CFR_LIST>
            <CFR>42 CFR 429</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>Pub. L. 117-169, Sec. 11001 and 11002</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>Pub. L. 119-21, Sec. 71203</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>07/00/2026</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>Federal</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>No</FEDERALISM>
        <PRINT_PAPER>Yes</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>No</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Elisabeth</FIRST_NAME>
                <LAST_NAME>Daniel</LAST_NAME>
                <TITLE>Director, Division of Policy</TITLE>
                <AGENCY>
                    <CODE>0938</CODE>
                    <NAME>Centers for Medicare &amp; Medicaid Services</NAME>
                    <ACRONYM>CMS</ACRONYM>
                </AGENCY>
                <PHONE>410 786-0549</PHONE>
                <EMAIL>elisabeth.daniel@cms.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Center for Medicare, 7500 Security Blvd,</STREET_ADDRESS>
                    <CITY>Baltimore</CITY>
                    <STATE>MD</STATE>
                    <ZIP>21244</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
