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    <RIN_INFO>
        <RIN>0910-AG73</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>201304</PUBLICATION_ID>
            <PUBLICATION_TITLE>Update to the 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>Establishment, Maintenance, and Availability of Records:  Amendment to Record Availability Requirements</RULE_TITLE>
        <ABSTRACT><![CDATA[This final rule will adopt FDA's interim final rule that amended the regulation on record availability requirements, including expansion of FDA records access.]]></ABSTRACT>
        <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 1.361</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>PL 107-188</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>PL 111-353</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>5 USC 553(b)(3)(B) and 21 CFR 10.40(e)(1)</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>5 USC 553(d)(3) and 21 CFR 10.40(d)</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 350c(a)</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 374(a)</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>Interim Final Rule Comment Period End</TTBL_ACTION>
                <TTBL_DATE>05/23/2013</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Interim Final Rule</TTBL_ACTION>
                <TTBL_DATE>02/23/2012</TTBL_DATE>
                <FR_CITATION>77 FR 10658</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Interim Final Rule Effective</TTBL_ACTION>
                <TTBL_DATE>03/01/2012</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Final Action</TTBL_ACTION>
                <TTBL_DATE>01/00/2014</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>No</RFA_REQUIRED>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>None</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>No</FEDERALISM>
        <ENERGY_AFFECTED>No</ENERGY_AFFECTED>
        <PRINT_PAPER>No</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>No</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>William</FIRST_NAME>
                <LAST_NAME>Correll, Jr.</LAST_NAME>
                <MIDDLE_NAME>A.</MIDDLE_NAME>
                <TITLE>Supervisory Consumer Safety Officer</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>240 402-1611</PHONE>
                <FAX>301 436-2716</FAX>
                <EMAIL>william.correll@fda.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Room 3C-019, CPK1, HFS-607, 5100 Paint Branch Parkway,</STREET_ADDRESS>
                    <CITY>College Park</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20740</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
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