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<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-06-03-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0910-AG20</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>201704</PUBLICATION_ID>
            <PUBLICATION_TITLE>Unified Agenda of Federal Regulatory and Deregulatory Actions</PUBLICATION_TITLE>
        </PUBLICATION>
        <AGENCY>
            <CODE>0910</CODE>
            <NAME>Food and Drug Administration</NAME>
            <ACRONYM>FDA</ACRONYM>
        </AGENCY>
        <PARENT_AGENCY>
            <CODE>0900</CODE>
            <NAME>Department of Health and Human Services</NAME>
            <ACRONYM>HHS</ACRONYM>
        </PARENT_AGENCY>
        <RULE_TITLE>Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals--Second Phase</RULE_TITLE>
        <ABSTRACT><![CDATA[FDA will revise regulations for "current good manufacturing practice" for oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products. This revision will update and harmonize requirements and improve detection and response to emerging product safety and quality signals. ]]></ABSTRACT>
        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Completed Actions</RULE_STAGE>
        <MAJOR>Undetermined</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>Undetermined</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>21 CFR 210</CFR>
            <CFR>21 CFR 211</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 U.S.C. 321</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 U.S.C. 351</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 U.S.C. 352</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 U.S.C. 355</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 U.S.C. 360b</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 U.S.C. 371</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 U.S.C. 374</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 U.S.C. 262</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 U.S.C. 264</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>Withdrawn</TTBL_ACTION>
                <TTBL_DATE>06/08/2017</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>Yes</RFA_REQUIRED>
        <SMALL_ENTITY_LIST>
            <SMALL_ENTITY>Businesses</SMALL_ENTITY>
        </SMALL_ENTITY_LIST>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>None</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>No</FEDERALISM>
        <ENERGY_AFFECTED>Undetermined</ENERGY_AFFECTED>
        <PRINT_PAPER>Yes</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>Yes</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Paula</FIRST_NAME>
                <LAST_NAME>Katz</LAST_NAME>
                <TITLE>Regulatory Counsel, Office of Compliance</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>301 796-6972</PHONE>
                <FAX>301 847-8742</FAX>
                <EMAIL>paula.katz@fda.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 4314, 10903 New Hampshire Avenue,</STREET_ADDRESS>
                    <CITY>Silver Spring</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20993</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
