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<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-08-26-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0906-AA89</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>201104</PUBLICATION_ID>
            <PUBLICATION_TITLE>Unified Agenda of Federal Regulatory and Deregulatory Actions</PUBLICATION_TITLE>
        </PUBLICATION>
        <AGENCY>
            <CODE>0906</CODE>
            <NAME>Health Resources and Services Administration</NAME>
            <ACRONYM>HRSA</ACRONYM>
        </AGENCY>
        <PARENT_AGENCY>
            <CODE>0900</CODE>
            <NAME>Department of Health and Human Services</NAME>
            <ACRONYM>HHS</ACRONYM>
        </PARENT_AGENCY>
        <RULE_TITLE>340B Drug Pricing Program; Manufacturer Civil Monetary Penalties </RULE_TITLE>
        <ABSTRACT><![CDATA[This rulemaking is required under the Affordable Care Act.  The purpose is to implement an enhancement to the 340B Program.  It amends section 340B of the Public Health Service Act to impose monetary sanctions (not to exceed $5,000 per instance) on drug manufacturers who intentionally charge a covered entity (aka "safety net provider") a price above the ceiling price established under the procedures of the 340B Program.]]></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>No</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>Not Yet Determined</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>Sec 7102 of the Affordable Care Act</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>PL 111-148 amending subsec.(d)</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>sec 340B PHS Act</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST>
            <LEGAL_DLINE_INFO>
                <DLINE_TYPE>Statutory</DLINE_TYPE>
                <DLINE_ACTION_STAGE>Other</DLINE_ACTION_STAGE>
                <DLINE_DATE>09/20/2010</DLINE_DATE>
                <DLINE_DESC>ANPRM met deadline</DLINE_DESC>
            </LEGAL_DLINE_INFO>
        </LEGAL_DLINE_LIST>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>ANPRM</TTBL_ACTION>
                <TTBL_DATE>09/20/2010</TTBL_DATE>
                <FR_CITATION>75 FR 57230</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>ANPRM Comment Period End</TTBL_ACTION>
                <TTBL_DATE>11/19/2010</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>07/00/2011</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>Undetermined</RFA_REQUIRED>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>None</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>No</FEDERALISM>
        <ENERGY_AFFECTED>No</ENERGY_AFFECTED>
        <PRINT_PAPER>No</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>No</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Bradford</FIRST_NAME>
                <LAST_NAME>Lang</LAST_NAME>
                <TITLE>Public Health Analyst/Health Care System Bureau</TITLE>
                <AGENCY>
                    <CODE>0906</CODE>
                    <NAME>Health Resources and Services Administration</NAME>
                    <ACRONYM>HRSA</ACRONYM>
                </AGENCY>
                <PHONE>301 443-2671</PHONE>
                <FAX>301 594-4982</FAX>
                <EMAIL>blang@hrsa.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>5600 Fishers Lane, Room 10C-03,</STREET_ADDRESS>
                    <CITY>Rockville</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20857</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
