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    <RIN_INFO>
        <RIN>1545-BR16</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>1545</CODE>
            <NAME>Internal Revenue Service</NAME>
            <ACRONYM>IRS</ACRONYM>
        </AGENCY>
        <PARENT_AGENCY>
            <CODE>1500</CODE>
            <NAME>Department of the Treasury</NAME>
            <ACRONYM>TREAS</ACRONYM>
        </PARENT_AGENCY>
        <RULE_TITLE>Branded Prescription Drug Fee Discounts</RULE_TITLE>
        <ABSTRACT><![CDATA[<!DOCTYPE html>
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<p>The proposed regulation updates 51.4(b)(2)(i)(B) and (iv) of the Branded Prescription Drug Fee Regulations, which currently cite to the Coverage Gap Discount Program described in section 1860D-14A of the SSA (42 U.S.C.1395w-114a), to reflect that the Inflation Reduction Act terminated this program and replaced it with the Manufacturer Discount Program described in section 1860D-14C of the SSA (42 U.S.C. 1395w-114c). The proposed regulations would also update 51.11 to reflect the applicability date for proposed 51.4(b)(2)(i)(B) and (iv). This regulatory action is aligned with Executive Order 14273, Lowering Drug Prices by Once Again Putting Americans First (Apr. 15, 2025). Additionally, updating the regulations to conform with recent statutory changes reduces the compliance burden for feepayers.</p>
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        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Proposed Rule Stage</RULE_STAGE>
        <MAJOR>No</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <EO_13771_DESIGNATION>Deregulatory</EO_13771_DESIGNATION>
        <CFR_LIST>
            <CFR>26 CFR part 51 (Revision)</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>Pub. L. 117-169, sec. 11201</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>26 U.S.C. 7805</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>
        <ADDITIONAL_INFO>REG-103430-24

Drafting attorney: Julia Barlow, (202) 317-3305

Reviewing attorney: Charles Langley, (202) 317-5274

Treasury attorney: Shelley Leonard, (202) 622-2172

CC: ECE</ADDITIONAL_INFO>
        <RFA_REQUIRED>No</RFA_REQUIRED>
        <SMALL_ENTITY_LIST>
            <SMALL_ENTITY>No</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>
        <RELATED_RIN_LIST>
            <RELATED_RIN>
                <RIN>1545-BJ39</RIN>
                <RIN_RELATION>Related to</RIN_RELATION>
            </RELATED_RIN>
        </RELATED_RIN_LIST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Julia</FIRST_NAME>
                <LAST_NAME>Barlow</LAST_NAME>
                <TITLE>Attorney</TITLE>
                <AGENCY>
                    <CODE>1545</CODE>
                    <NAME>Internal Revenue Service</NAME>
                    <ACRONYM>IRS</ACRONYM>
                </AGENCY>
                <PHONE>202 317-3305</PHONE>
                <EMAIL>julia.c.barlow@irscounsel.treas.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>1111 Constitution Avenue NW, Room 5316,</STREET_ADDRESS>
                    <CITY>Washington</CITY>
                    <STATE>DC</STATE>
                    <ZIP>20224</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
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