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    <RIN_INFO>
        <RIN>1117-AB49</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>202304</PUBLICATION_ID>
            <PUBLICATION_TITLE>Unified Agenda of Federal Regulatory and Deregulatory Actions</PUBLICATION_TITLE>
        </PUBLICATION>
        <AGENCY>
            <CODE>1117</CODE>
            <NAME>Drug Enforcement Administration</NAME>
            <ACRONYM>DEA</ACRONYM>
        </AGENCY>
        <PARENT_AGENCY>
            <CODE>1100</CODE>
            <NAME>Department of Justice</NAME>
            <ACRONYM>DOJ</ACRONYM>
        </PARENT_AGENCY>
        <RULE_TITLE>Management of Quotas for Controlled Substances and List I Chemicals</RULE_TITLE>
        <ABSTRACT><![CDATA[<!DOCTYPE html>
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<p>The Drug Enforcement Administration (DEA) is revising and amending existing regulations to reduce overall inventories held by DEA-registered manufacturers and other registrants; to create use-specific subcategories for procurement quotas; and to clarify the current language and ensure that both manufacturers and distributors are required to obtain certification of a buyer&rsquo;s quota for the requested schedules I and II controlled substances, as well as list I chemicals.&nbsp; These changes are necessary, in light of the increasingly complex controlled substances manufacturing business practices, to reduce the potential for the diversion of certain controlled substances.&nbsp; Due to this evolution of complexity in the pharmaceutical industry and the inflexible nature of the regulations by which DEA must calculate inventory allowances for manufacturers of controlled substances, the current inventory allowances provide opportunity for the accumulation of controlled substance surpluses to occur.&nbsp; These proposed regulations will rectify a situation where DEA&rsquo;s ability to strike an appropriate balance between ensuring the availability of controlled substances to industry and the risk to public health and safety has been hindered and resulted in an overproduction of controlled substances inventories available for diversion.</p>
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        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Final Rule Stage</RULE_STAGE>
        <MAJOR>No</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>21 CFR 1303</CFR>
            <CFR>21 CFR 1315</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 U.S.C. 821</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 U.S.C. 826</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 U.S.C. 871(b)</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>10/23/2019</TTBL_DATE>
                <FR_CITATION>84 FR 56712</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM Comment Period End</TTBL_ACTION>
                <TTBL_DATE>12/23/2019</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Final Action</TTBL_ACTION>
                <TTBL_DATE>08/00/2023</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <ADDITIONAL_INFO>DEA Docket number 455</ADDITIONAL_INFO>
        <RFA_REQUIRED>No</RFA_REQUIRED>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>None</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>No</FEDERALISM>
        <FURTHER_INFO_URL>DPW@dea.gov</FURTHER_INFO_URL>
        <PUBLIC_COMMENT_URL>www.regulations.gov/</PUBLIC_COMMENT_URL>
        <PRINT_PAPER>No</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>No</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Scott</FIRST_NAME>
                <LAST_NAME>Brinks</LAST_NAME>
                <MIDDLE_NAME>A.</MIDDLE_NAME>
                <TITLE>Section Chief, Regulatory Drafting and Support Section, Diversion Control Division</TITLE>
                <AGENCY>
                    <CODE>1117</CODE>
                    <NAME>Drug Enforcement Administration</NAME>
                    <ACRONYM>DEA</ACRONYM>
                </AGENCY>
                <PHONE>571 362-8209</PHONE>
                <EMAIL>scott.a.brinks@dea.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>8701 Morrissette Drive,</STREET_ADDRESS>
                    <CITY>Springfield</CITY>
                    <STATE>VA</STATE>
                    <ZIP>22152</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
