Document ID: FDA-2008-E-0114-0013
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-10-22T04:00Z

<!DOCTYPE HTML PUBLIC "-//-//W3C//DTD HTML 3.2//EN">
<HTML>
<HEAD>
<META name="generator" content="PDFCreactiveX HTML Export">
<META name="creation-date" content="08/07/2008 11:46:17 ">
<TITLE></TITLE>
<SCRIPT LANGUAGE="JavaScript1.2"> var agt=navigator.userAgent.toLowerCase();if ( (parseInt(navigator.appVersion)>=4) &&(agt.indexOf('mozilla')!=-1) && (agt.indexOf('spoofer')==-1)&& (agt.indexOf('compatible') == -1) ){msie = false;} else if ( (parseInt(navigator.appVersion)>=4) &&(agt.indexOf('msie') != -1) ) {msie = true;	} page=0;</SCRIPT>
</HEAD>
<BODY bgcolor="#ffffff" text="#000000" topmargin=0 leftmargin=0 marginheight=0 marginwidth=0 >
<SPAN STYLE="color:#000000;position:absolute;left:206.75pt;top:203.10pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:285.70pt;top:257.75pt;z-index:3;"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:792.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:192.25pt;top:894.95pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:125.15pt;top:927.35pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:89.05pt;top:948.35pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:89.30pt;top:968.90pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:89.05pt;top:989.40pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:89.50pt;top:1009.90pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:89.30pt;top:1030.45pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.30pt;top:1064.75pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.30pt;top:1082.90pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.75pt;top:1100.15pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.75pt;top:1117.80pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.50pt;top:1135.55pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.50pt;top:1153.20pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:346.55pt;top:1156.10pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:355.80pt;top:1153.20pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.75pt;top:1170.50pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.75pt;top:1188.35pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.00pt;top:1206.15pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:219.85pt;top:1206.95pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:232.10pt;top:1206.10pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.00pt;top:1224.00pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.00pt;top:1241.75pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.00pt;top:1259.55pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.00pt;top:1276.90pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.00pt;top:1294.60pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.00pt;top:1308.35pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.00pt;top:1326.25pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.00pt;top:1344.00pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.25pt;top:1361.45pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.50pt;top:1380.15pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.25pt;top:1397.75pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.00pt;top:1415.30pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:238.20pt;top:1415.90pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.40pt;top:1415.30pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.00pt;top:1433.15pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.45pt;top:1450.95pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.45pt;top:1468.45pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.00pt;top:1481.90pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.25pt;top:1499.75pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.25pt;top:1517.30pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:285.25pt;top:1551.95pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:308.65pt;top:1552.60pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:315.25pt;top:1551.65pt;z-index:3;"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:1584.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:169.65pt;top:1671.05pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.15pt;top:1688.65pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.35pt;top:1706.30pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.15pt;top:1724.05pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.60pt;top:1737.85pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.60pt;top:1755.15pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.60pt;top:1773.05pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.85pt;top:1790.55pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.10pt;top:1807.95pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.30pt;top:1821.85pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.60pt;top:1839.60pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.30pt;top:1857.00pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.30pt;top:1870.95pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.55pt;top:1888.60pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.80pt;top:1906.60pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.05pt;top:1924.00pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.05pt;top:1941.50pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.25pt;top:1959.15pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.05pt;top:1976.30pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:297.80pt;top:1976.60pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:304.75pt;top:1976.65pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.05pt;top:1994.55pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.50pt;top:2012.05pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.50pt;top:2029.95pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.25pt;top:2043.40pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.75pt;top:2061.30pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.75pt;top:2078.80pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.50pt;top:2096.70pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.50pt;top:2114.20pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.75pt;top:2131.85pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.50pt;top:2149.60pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:173.00pt;top:2167.45pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:173.25pt;top:2185.25pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.75pt;top:2203.10pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:173.25pt;top:2216.80pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:173.25pt;top:2234.30pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:173.00pt;top:2251.70pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:173.50pt;top:2269.25pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:173.50pt;top:2286.85pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:173.50pt;top:2304.40pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:286.40pt;top:2335.80pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:326.70pt;top:2336.25pt;z-index:3;"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:2377.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:169.95pt;top:2464.60pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:169.75pt;top:2482.50pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:169.95pt;top:2500.15pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.45pt;top:2517.40pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.45pt;top:2535.05pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.70pt;top:2552.95pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.70pt;top:2570.80pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.90pt;top:2588.45pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.90pt;top:2606.10pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.90pt;top:2623.75pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.40pt;top:2641.40pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:170.90pt;top:2659.00pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.15pt;top:2676.65pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.40pt;top:2694.30pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.65pt;top:2712.20pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.65pt;top:2729.80pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.65pt;top:2747.20pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.85pt;top:2765.35pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:171.85pt;top:2782.75pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.10pt;top:2800.15pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.10pt;top:2817.80pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.10pt;top:2835.65pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.35pt;top:2853.30pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.15pt;top:2871.20pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.15pt;top:2889.05pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.35pt;top:2906.70pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.35pt;top:2924.35pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.60pt;top:2942.20pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.60pt;top:2960.10pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.60pt;top:2977.75pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.60pt;top:2995.60pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.85pt;top:3013.50pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.60pt;top:3031.40pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.35pt;top:3048.80pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.35pt;top:3066.55pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.60pt;top:3083.95pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.60pt;top:3101.20pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:285.90pt;top:3130.50pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:326.10pt;top:3131.20pt;z-index:3;"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:3173.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:164.15pt;top:3258.30pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:163.95pt;top:3276.50pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:164.15pt;top:3290.05pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:164.65pt;top:3307.85pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:164.40pt;top:3325.45pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:164.65pt;top:3343.00pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:164.65pt;top:3360.85pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:164.90pt;top:3378.40pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:465.35pt;top:3378.80pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:476.05pt;top:3378.40pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:164.65pt;top:3392.05pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:165.10pt;top:3409.70pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:165.10pt;top:3427.70pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:165.35pt;top:3445.10pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:359.40pt;top:3445.15pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:371.75pt;top:3445.10pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:165.60pt;top:3462.65pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:165.60pt;top:3480.50pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:165.60pt;top:3498.05pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:166.10pt;top:3515.65pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:166.10pt;top:3533.40pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:166.10pt;top:3551.05pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:166.55pt;top:3568.80pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:166.30pt;top:3586.20pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:166.10pt;top:3604.00pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:166.30pt;top:3621.60pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:166.55pt;top:3639.15pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:166.80pt;top:3657.00pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:166.30pt;top:3674.55pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:166.30pt;top:3688.60pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:166.80pt;top:3706.35pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:166.80pt;top:3724.25pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:167.05pt;top:3742.00pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:166.80pt;top:3759.40pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:167.30pt;top:3777.15pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:167.30pt;top:3795.05pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:167.05pt;top:3812.80pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:167.30pt;top:3830.40pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:280.90pt;top:3924.00pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:302.40pt;top:3924.25pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:310.30pt;top:3924.10pt;z-index:3;"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:320.90pt;top:3924.90pt;z-index:3;"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:3967.00pt"> </SPAN>
</BODY>
</HTML>