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    <RIN_INFO>
        <RIN>0910-AG47</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>201004</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>Good Laboratory Practice for Nonclinical Laboratory Studies</RULE_TITLE>
        <ABSTRACT><![CDATA[The Food and Drug Administration (FDA) is seeking comment on whether to amend the regulation governing good laboratory practices (GLPs) (21 CFR part 58--Good Laboratory Practice for Nonclinical Laboratory Studies).  The GLP regulation was finalized in December 1978 and prescribes GLPs for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for FDA-regulated products.  Since this regulation was published, clinical studies have changed markedly.  To help ensure the integrity of data in nonclinical studies submitted to FDA, the agency is proposing that nonclinical facilities/laboratories follow a risk-based GLP quality system.  While many of the requirements of the existing regulation are consistent with a GLP quality system, FDA is proposing modifications to incorporate all basic elements needed for a GLP quality system consistent with internationally recognized quality systems.  FDA believes that implementation of a GLP quality system would institute a risk-based approach, reduce regulatory burden, and encourage science-based technology.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>First Time 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>
        <CFR_LIST>
            <CFR>21 CFR 58 (revision)</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 USC 342</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 346 and 346a</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 348</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 351 to 353</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 355</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>...</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>ANPRM</TTBL_ACTION>
                <TTBL_DATE>06/00/2010</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>ANPRM Comment Period End</TTBL_ACTION>
                <TTBL_DATE>09/00/2010</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>No</RFA_REQUIRED>
        <SMALL_ENTITY_LIST>
            <SMALL_ENTITY>Businesses</SMALL_ENTITY>
        </SMALL_ENTITY_LIST>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>Undetermined</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>No</FEDERALISM>
        <PRINT_PAPER>No</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>Yes</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>C.T.</FIRST_NAME>
                <LAST_NAME>Viswanathan</LAST_NAME>
                <TITLE>Associate Director, Division of Scientific Investigations, Office of Compliance</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>301 796-3394</PHONE>
                <FAX>301 847-8748</FAX>
                <EMAIL>ct.viswanathan@fda.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Center for Drug Evaluation and Research, WO 51, Room 5346, 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>
