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    <RIN_INFO>
        <RIN>0910-AF71</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>200704</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>Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality Systems Regulations</RULE_TITLE>
        <ABSTRACT><![CDATA[FDA is initiating a review under section 610 of the Regulatory Flexibility Act for the regulations in part 820.  The purpose of this review is to determine if any of the regulations in part 820 should be continued without change, or should be amended or rescinded, to minimize adverse economic impacts on small entities.  FDA will consider and is soliciting comments on the following: 1) The continued need for a regulation in part 820; 2) the nature of complaints or comments received concerning a regulation in part 820; 3) the complexity of a regulation in part 820; 4) the extent to which a regulation in part 820 overlaps, duplicates, or conflicts with other Federal, State, or local government rules; and 5) the degree to which technology, economic conditions, or other factors have changed in the area affected by a regulation in part 820.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Routine and Frequent</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Prerule Stage</RULE_STAGE>
        <MAJOR>No</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <RFA_SECTION_610_REVIEW>Section 610 Review</RFA_SECTION_610_REVIEW>
        <CFR_LIST>
            <CFR>21 CFR 808</CFR>
            <CFR>21 CFR 812</CFR>
            <CFR>21 CFR 820</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>5 USC 610</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>Begin Review of Current Regulation</TTBL_ACTION>
                <TTBL_DATE>04/00/2007</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>End Review</TTBL_ACTION>
                <TTBL_DATE>12/00/2007</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>No</RFA_REQUIRED>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>Undetermined</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>Undetermined</FEDERALISM>
        <PRINT_PAPER>NA</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>Not Collected</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Madhusoodana</FIRST_NAME>
                <LAST_NAME>Nambiar</LAST_NAME>
                <TITLE>Regulatory Counsel</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>301 796-5837</PHONE>
                <FAX>301 847-8145</FAX>
                <EMAIL>madhusoodana.nambiar@fda.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Center for Devices and Radiological Health, WO 66, Room 5518, 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>
