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    <RIN_INFO>
        <RIN>0906-AA89</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>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 Civil Monetary Penalties for Manufacturers </RULE_TITLE>
        <ABSTRACT><![CDATA[This rule is required under the Affordable Care Act and would amend 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 a price above the ceiling price established under the procedures of the 340B Program.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Info./Admin./Other</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Long-Term Actions</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>To Be Determined</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>
