Document ID: FDA-2008-D-0372-0004
Agency: fda
Document Type: Notice
Title: Global Harmonisation Task Force, Study Groups 1 and 5; Proposed and Final Documents; Availabililty; Correction
Posted Date: 2008-09-23T04:00Z

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<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:33.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 11.00pt">54600</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:131.55pt;top:34.55pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 10.00pt">Federal Register/Vol. 73, No. 184 /Monday, September 22, 2008 /Notices</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:61.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">DEPARTMENT OF HEALTH AND</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:71.65pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">HUMAN SERVICES</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:90.45pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Centers for Disease Control and</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:100.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Prevention</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:119.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Advisory Council for the Elimination of</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:129.45pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Tuberculosis Meeting (ACET)</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:148.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">In accordance with section 10(a)(2) of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:158.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Federal Advisory Committee Act</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:168.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(Pub. L. 92–463), the Centers for Disease</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:178.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Control and Prevention (CDC)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:188.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">announces the following council</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:198.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">meeting.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:212.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Times and Dates:</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:225.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">8:30 a.m.–5:30 p.m., October 7, 2008.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:238.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">8:30 a.m.–2 p.m., October 8, 2008.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:251.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Place: Corporate Square, Building 8,</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:261.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">1st Floor Conference Room, Atlanta,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:271.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Georgia 30333, Telephone (404) 639–</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:282.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">8317.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:295.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Status: Open to the public, limited</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:305.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">only by the space available. The meeting</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:315.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">room accommodates approximately 100</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:325.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">people.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:338.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Purpose: This council advises and</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:348.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">makes recommendations to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:358.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Secretary of Health and Human</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:369.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Services, the Assistant Secretary for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:379.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Health, and the Director, CDC, regarding</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:389.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the elimination of tuberculosis.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:399.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Specifically, the Council makes</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:409.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">recommendations regarding policies,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:419.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">strategies, objectives, and priorities;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:429.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">addresses the development and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:439.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">application of new technologies; and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:449.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">reviews the extent to which progress has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:459.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">been made toward eliminating</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:469.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">tuberculosis.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:482.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Matters to be Discussed: Agenda items</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:492.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">include issues pertaining to update on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:502.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">nucleic acid amplification guidelines;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:512.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">update on interferon gamma release</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:522.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">assays guidelines; update on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:532.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">isolation guidelines; update on travel</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:542.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">restrictions guidelines and other related</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:552.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">tuberculosis issues.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:565.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Agenda items are subject to change as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:575.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">priorities dictate.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:589.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Contact Person for More Information:</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:599.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Margie Scott-Cseh, Coordinating Center</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:609.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for Infectious Diseases, Strategic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:619.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Business Unit, 1600 Clifton Road, NE.,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:629.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">M/S E–07, Atlanta, Georgia 30333,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:639.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Telephone (404) 639–8317.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:652.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The Director, Management Analysis</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:662.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and Services Office, has been delegated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:672.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the authority to sign </FONT></FONT><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Federal Register</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:682.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Notices pertaining to announcements of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:692.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">meetings and other committee</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:702.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">management activities, for both the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:712.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Centers for Disease Control and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:722.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Prevention and the Agency for Toxic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:732.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Substances and Disease Registry.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:60.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Dated: September 15, 2008.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:70.85pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Elaine L. Baker,</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:81.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Director, Management Analysis and Services</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:90.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Office, Centers for Disease Control and</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:99.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Prevention (CDC).</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:110.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">[FR Doc. E8–22040 Filed 9–19–08; 8:45 am]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:123.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 6.00pt">BILLING CODE 4163–18–P</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:149.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">DEPARTMENT OF HEALTH AND</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:159.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">HUMAN SERVICES</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:177.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Food and Drug Administration</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:192.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">[Docket No. FDA–2008–D–0372]</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:209.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Global Harmonization Task Force,</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:219.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Study Groups 1 and 5; Proposed and</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:229.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Final Documents; Availability;</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:239.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Correction</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:254.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">AGENCY</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.25pt;top:254.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Food and Drug Administration,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:264.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">HHS.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:275.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">ACTION</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:255.05pt;top:275.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Notice; correction.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:292.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">SUMMARY</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.65pt;top:291.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The Food and Drug</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:301.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Administration (FDA) is correcting a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:311.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">notice that appeared in the </FONT></FONT><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Federal</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:321.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Register of July 11, 2008 (73 FR 39968).</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:331.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The notice announced the availability of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:341.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Global Harmonization Task Force</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:351.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">documents entitled ‘‘Role of Standards’’</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:361.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and ‘‘Clinical Investigations.’’ The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:371.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">notice was published with an incorrect</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:381.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">document number. This document</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:391.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">corrects that number.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:403.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">FOR FURTHER INFORMATION CONTACT</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:370.45pt;top:403.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Paul</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:413.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Gadiock, Center for Devices and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:423.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Radiological Health (HFZ–215), Food</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:433.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and Drug Administration, 1350 Piccard</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:443.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Dr., Rockville, MD 20850, 240–276–</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:453.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2343.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:468.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">SUPPLEMENTARY INFORMATION</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:345.10pt;top:468.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">In FR Doc.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:478.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">E8–15797, appearing on page 39968 in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:488.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 9.00pt">Federal Register </FONT></b><FONT STYLE="font-size: 9.00pt">of Friday, July 11,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:498.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2008, the following correction is made:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:507.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">1. On page 39968, in the third</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:517.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">column, in the third paragraph, in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:527.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">8th and 9th lines, ‘‘SG5(PD)/N37:2007’’</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:537.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">is corrected to read ‘‘SG5(PD)/</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:547.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">N3R7:2007.’’</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:561.15pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Dated: September 11, 2008.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:572.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Jeffrey Shuren,</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:582.95pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Associate Commissioner for Policy and</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:591.95pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Planning.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:602.95pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">[FR Doc. E8–22094 Filed 9–19–08; 8:45 am]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:615.50pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 6.00pt">BILLING CODE 4160–01–S</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:641.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">DEPARTMENT OF HEALTH AND</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:651.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">HUMAN SERVICES</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:669.45pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">National Institutes of Health</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:687.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Center for Scientific Review; Amended</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:697.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Notice of Meeting</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:712.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Notice is hereby given of a change in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:722.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the meeting of the Biophysics of Neural</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:732.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Systems Study Section, October 2, 2008,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:60.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">8 am to October 3, 2008, 5 pm, One</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:70.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Washington Circle Hotel, One</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:80.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Washington Circle, Washington, DC</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:90.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">20037 which was published in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:100.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Federal Register on September 9, 2008,</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:110.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">73 FR 52395–52397.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:121.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The meeting will be held one day</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:131.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">only October 2, 2008, from 8 am to 8</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:141.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">pm. The meeting location remains the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:151.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">same. The meeting is closed to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:161.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">public.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.00pt;top:175.35pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Dated: September 15, 2008.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:186.35pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Jennifer Spaeth,</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:197.35pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Director, Office of Federal Advisory</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:206.35pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Committee Policy.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:217.35pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">[FR Doc. E8–22055 Filed 9–19–08; 8:45 am]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:230.00pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 6.00pt">BILLING CODE 4140–01–M</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:256.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">DEPARTMENT OF HEALTH AND</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:266.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">HUMAN SERVICES</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:284.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">National Institutes of Health</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:302.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">National Institute of Diabetes and</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:312.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Digestive And Kidney Diseases; Notice</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:322.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of Closed Meetings</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:339.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Pursuant to section 10(d) of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:349.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Federal Advisory Committee Act, as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:359.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">amended (5 U.S.C. Appendix 2), notice</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:369.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">is hereby given of the following</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:379.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">meetings.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:390.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The meetings will be closed to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:400.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">public in accordance with the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:410.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">provisions set forth in sections</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:420.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:430.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">as amended. The grant applications and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:440.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the discussions could disclose</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:450.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">confidential trade secrets or commercial</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:460.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">property such as patentable material,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:470.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and personal information concerning</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:480.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">individuals associated with the grant</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:490.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">applications, the disclosure of which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:500.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">would constitute a clearly unwarranted</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:510.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">invasion of personal privacy.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.00pt;top:524.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Name of Committee: National Institute of</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:533.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Diabetes and Digestive and Kidney Diseases</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:542.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Special Emphasis Panel; R13 Conference</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:551.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Application.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.00pt;top:560.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Date: October 23, 2008.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.00pt;top:569.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Time: 2 p.m. to 4 p.m.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.00pt;top:578.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Agenda: To review and evaluate grant</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:587.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">applications.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.00pt;top:596.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Place: National Institutes of Health, Two</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:605.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Democracy Plaza, 6707 Democracy</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:614.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Boulevard, Bethesda, MD 20892 (Telephone</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:623.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Conference Call).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.00pt;top:632.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Contact Person: D.G. Patel, PhD, Scientific</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:641.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Review Officer, Review Branch, DEA,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:650.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">NIDDK, National Institutes of Health, Room</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:659.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">756, 6707 Democracy Boulevard, Bethesda,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:668.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">MD 20892–5452, (301) 594–7682,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:677.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">pateldg@niddk.nih.gov.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.00pt;top:688.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Name of Committee: National Institute of</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:697.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Diabetes and Digestive and Kidney Diseases</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:706.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Special Emphasis Panel; Ancillary Study for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:715.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">PKD.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.00pt;top:724.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Date: October 27, 2008.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.00pt;top:733.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Time: 12 p.m. to 2 p.m.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:25.00pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">VerDate Aug<31>2005</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:100.30pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">19:11 Sep 19, 2008</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:164.05pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Jkt 214001</FONT></FONT></FONT></SPAN>
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<SPAN STYLE="color:#000000;position:absolute;left:239.10pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Frm 00047</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:277.55pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Fmt 4703</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:312.00pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Sfmt 4703</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:348.60pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">E:\FR\FM\22SEN1.SGM</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:426.05pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">22SEN1</FONT></FONT></FONT></SPAN>
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