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<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-05-17-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0936-AA08</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>201810</PUBLICATION_ID>
            <PUBLICATION_TITLE>The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions</PUBLICATION_TITLE>
        </PUBLICATION>
        <AGENCY>
            <CODE>0936</CODE>
            <NAME>Office of the Inspector General</NAME>
            <ACRONYM>OIG</ACRONYM>
        </AGENCY>
        <PARENT_AGENCY>
            <CODE>0900</CODE>
            <NAME>Department of Health and Human Services</NAME>
            <ACRONYM>HHS</ACRONYM>
        </PARENT_AGENCY>
        <RULE_TITLE>Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection</RULE_TITLE>
        <ABSTRACT><![CDATA[<!DOCTYPE html>
<html>
<head>
</head>
<body>
<p>The NPRM would revise the discount safe harbor related to rebates to plans or pharmacy benefit managers involving pharmaceuticals. In addition, this NPRM proposes a new safe harbor.</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>Undetermined</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>Undetermined</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <EO_13771_DESIGNATION>Regulatory</EO_13771_DESIGNATION>
        <CFR_LIST>
            <CFR>42 CFR 1001.952(h) (to be modified)</CFR>
            <CFR>42 CFR 1001.953(cc) (to be added)</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>sec. 14 of the Medicare and Medicaid Patient and Program Protection Act of 1987</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>10/00/2018</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>No</RFA_REQUIRED>
        <SMALL_ENTITY_LIST>
            <SMALL_ENTITY>No</SMALL_ENTITY>
        </SMALL_ENTITY_LIST>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>Undetermined</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>No</FEDERALISM>
        <PRINT_PAPER>No</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>No</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Aaron</FIRST_NAME>
                <LAST_NAME>Zajic</LAST_NAME>
                <AGENCY>
                    <CODE>0936</CODE>
                    <NAME>Office of the Inspector General</NAME>
                    <ACRONYM>OIG</ACRONYM>
                </AGENCY>
                <PHONE>202 619-0335</PHONE>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS></STREET_ADDRESS>
                    <CITY>Washington</CITY>
                    <STATE>DC</STATE>
                    <ZIP>20201</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
