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    <RIN_INFO>
        <RIN>0910-AG04</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>200804</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</RULE_TITLE>
        <ABSTRACT><![CDATA[The Food and Drug Administration (FDA) is amending certain sections of 21 CFR parts 210 and 211 as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals in 21 CFR parts 210 and 211.  We are amending the regulations to modernize or clarify some of the CGMP requirements, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations.  These amendments are also consistent with current industry practice. We are taking this action as part of our continuing effort to revise outdated regulations without diminishing public health protection.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Routine and Frequent</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 210 to 211</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 USC 321</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 351 to 352</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 355</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 360b</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 371</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 374</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 216</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 262</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 263a to 264</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM-Companion to Direct Final Rule</TTBL_ACTION>
                <TTBL_DATE>12/04/2007</TTBL_DATE>
                <FR_CITATION>72 FR 68064</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Direct Final Rule</TTBL_ACTION>
                <TTBL_DATE>12/04/2007</TTBL_DATE>
                <FR_CITATION>72 FR 68113</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM Comment Period End</TTBL_ACTION>
                <TTBL_DATE>02/19/2008</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Direct Final Rule; Withdrawal</TTBL_ACTION>
                <TTBL_DATE>04/04/2008</TTBL_DATE>
                <FR_CITATION>73 FR 18440</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Final Action</TTBL_ACTION>
                <TTBL_DATE>12/00/2008</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>No</RFA_REQUIRED>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>None</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>No</FEDERALISM>
        <PRINT_PAPER>No</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>Not Collected</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Brian</FIRST_NAME>
                <LAST_NAME>Pendleton</LAST_NAME>
                <MIDDLE_NAME>L.</MIDDLE_NAME>
                <TITLE>Senior Policy Advisor</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>301 796-4614</PHONE>
                <FAX>301 847-3541</FAX>
                <EMAIL>brian.pendleton@fda.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Suite 3037 (HFD-7), Office of Policy, WO 32, Room 4250, 10903 New Hampshire Avenue,</STREET_ADDRESS>
                    <CITY>Silver Spring</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20993-0002</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
