Document ID: FDA-2007-D-0430-0005
Agency: fda
Document Type: Notice
Title: International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products: Guidance for Industry on Target Animal Safety for Veterinary Pharmaceutical Products, VICH GL43; Availability,
Posted Date: 2009-04-27T04:00Z

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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">19096</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:146.25pt;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. 74, No. 79 /Monday, April 27, 2009 /Notices</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:60.55pt;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:45.00pt;top:70.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Maribeth Badura, Director, Division of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:80.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Healthy Start and Perinatal Services,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:90.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Maternal and Child Health Bureau,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:100.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">HRSA, Room 18–12, Parklawn Building,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:110.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">5600 Fishers Lane, Rockville, Maryland</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:120.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">20857; telephone (301) 443–0543;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:130.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">e-mail </FONT></FONT><FONT COLOR="000000"><i><FONT STYLE="font-size: 9.00pt">MBadura@hrsa.gov</FONT></i><FONT STYLE="font-size: 9.00pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:53.00pt;top:143.85pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Dated: April 21, 2009.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:154.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Marcia K. Brand,</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:165.45pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Deputy Administrator.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:176.45pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">[FR Doc. E9–9517 Filed 4–24–09; 8:45 am]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:189.00pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 6.00pt">BILLING CODE 4165–15–P</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:215.05pt;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:225.05pt;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:242.95pt;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:45.00pt;top:258.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">[Docket No. FDA–2007–D–0430] (formerly</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:266.95pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Docket No. 2007D–0166)</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:284.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">International Cooperation on</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:294.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Harmonisation of Technical</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:304.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Requirements for Registration of</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:314.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Veterinary Medicinal Products (VICH);</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:324.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Guidance for Industry on ‘‘Target</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:334.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Animal Safety for Veterinary</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:344.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Pharmaceutical Products,’’ VICH GL43;</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:354.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Availability</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:369.35pt;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:81.25pt;top:369.10pt;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: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">HHS.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:390.55pt;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:78.05pt;top:390.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Notice.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:406.95pt;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:87.65pt;top:406.70pt;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:45.00pt;top:416.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Administration (FDA) is announcing the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:426.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">availability of a guidance for industry</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:436.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(#185) entitled ‘‘Target Animal Safety</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:446.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for Veterinary Pharmaceutical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:456.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Products,’’ VICH GL43. The purpose of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:466.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">this harmonized guidance is to provide</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:476.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">recommendations regarding target</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:486.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">animal safety (TAS) evaluation for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:496.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">regulatory submission of an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:506.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Investigational Veterinary</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:516.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Pharmaceutical Product (IVPP), which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:526.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">is appropriate for determining the safety</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:536.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of an IVPP in the target animal. The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:546.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">guidance includes recommendations on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:556.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">including identification of target organs,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:566.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">where possible, and confirmation of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:576.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">margin of safety, using the minimum</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:586.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">number of animals appropriate for the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:596.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">studies.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:610.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">DATES</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:74.85pt;top:609.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Submit written or electronic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:619.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">comments on agency guidances at any</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:629.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">time.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:643.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">ADDRESSES</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.25pt;top:643.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Submit written requests for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:653.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">single copies of the guidance to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:663.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Communications Staff (HFV–12), Center</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:673.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for Veterinary Medicine, Food and Drug</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:683.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Administration, 7519 Standish Pl.,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:693.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Rockville, MD 20855. Send one self-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:703.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">addressed adhesive label to assist that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:713.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">office in processing your requests.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:722.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Submit written comments on the</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">guidance to the Division of Dockets</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:60.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Management (HFA–305), Food and Drug</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:70.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Administration, 5630 Fishers Lane, rm.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:80.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">1061, Rockville, MD 20852. Submit</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:90.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">electronic comments to </FONT></FONT><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt"><a href="http://">http://</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt"></FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:100.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt"><a href="http://www.regulations.gov.">www.regulations.gov</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">. See the</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:111.70pt;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></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.10pt;top:110.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">section for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:120.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">electronic access to the guidance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:130.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">document.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:144.05pt;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:222.00pt;top:153.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Steven Vaughn, Center for Veterinary</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:163.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Medicine, (HFV–100), Food and Drug</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:173.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Administration, 7500 Standish Pl.,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:183.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Rockville, MD 20855, 240–276–8300, e-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:193.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">mail: </FONT></FONT><FONT COLOR="000000"><i><FONT STYLE="font-size: 9.00pt">steven.vaughn@fda.hhs.gov</FONT></i><FONT STYLE="font-size: 9.00pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:205.55pt;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:222.00pt;top:220.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">I. Background</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:233.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">In recent years, many important</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:243.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">initiatives have been undertaken by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:253.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">regulatory authorities and industry</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:263.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">associations to promote the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:273.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">international harmonization of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:283.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">regulatory requirements. FDA has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:293.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">participated in efforts to enhance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:303.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">harmonization and has expressed its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:313.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commitment to seek scientifically based</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:323.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">harmonized technical procedures for the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:333.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">development of pharmaceutical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:343.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">products. One of the goals of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:353.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">harmonization is to identify and then</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:363.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">reduce differences in technical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:373.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">requirements for drug development</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:383.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">among regulatory agencies in different</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:393.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">countries.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:403.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA has actively participated in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:413.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">International Conference on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:423.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Harmonisation of Technical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:433.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Requirements for Approval of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:443.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Pharmaceuticals for Human Use (VICH)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:453.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for several years to develop harmonized</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:463.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">technical requirements for the approval</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:473.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of human pharmaceutical and biological</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:483.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">products among the European Union,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:493.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Japan, and the United States. The VICH</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:503.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">is a parallel initiative for veterinary</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:513.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">medicinal products. The VICH is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:523.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">concerned with developing harmonized</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:533.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">technical requirements for the approval</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:543.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of veterinary medicinal products in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:553.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">European Union, Japan, and the United</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:563.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">States, and includes input from both</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:573.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">regulatory and industry representatives.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:582.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The VICH Steering Committee is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:592.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">composed of member representatives</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:602.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">from the European Commission,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:612.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">European Medicines Evaluation Agency,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:622.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">European Federation of Animal Health,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:632.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Committee on Veterinary Medicinal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:642.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Products, the U.S. FDA, the U.S.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:652.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Department of Agriculture, the Animal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:662.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Health Institute, the Japanese Veterinary</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:672.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Pharmaceutical Association, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:682.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Japanese Association of Veterinary</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:692.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Biologics, and the Japanese Ministry of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:702.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Agriculture, Forestry and Fisheries.</FONT></FONT></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">Four observers are eligible to</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">participate in the VICH Steering</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">Committee: One representative from the</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">government of Australia/New Zealand,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:70.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">one representative from the industry in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:80.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Australia/New Zealand, one</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:90.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">representative from the government of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:99.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Canada, and one representative from the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:109.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">industry of Canada. The VICH</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:119.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Secretariat, which coordinates the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:129.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">preparation of documentation, is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:139.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">provided by the International</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:149.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Federation for Animal Health (IFAH).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:159.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">An IFAH representative also</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:169.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">participates in the VICH Steering</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:179.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Committee meetings.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:193.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">II. Guidance on Target Animal Safety</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:203.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for Veterinary Pharmaceutical Products</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:217.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">In the </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 9.00pt">Federal Register </FONT></b><FONT STYLE="font-size: 9.00pt">of May 18,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:226.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2007 (72 FR 28058), FDA published the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:236.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">notice of availability for a draft guidance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:246.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">entitled ‘‘Draft Guidance for Industry on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:256.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Target Animal Safety for Veterinary</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:266.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Pharmaceutical Products,’’ which gave</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:276.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">interested persons until June 18, 2007,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:286.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to comment on the draft guidance. FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:296.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">received a few comments on the draft</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:306.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">guidance and those comments as well as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:316.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">those received by other VICH member</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:325.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">regulatory agencies were considered as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:335.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the guidance was finalized. Based on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:345.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the comments received, the VICH Expert</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:355.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Working Group on Target Animal Safety</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:365.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">clarified the guidance’s</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:375.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">recommendations regarding the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:385.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">development and conduct of TAS</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:395.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">studies. In particular, the Expert</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:405.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Working Group revised the sections</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:415.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">addressing necropsy and histopathology</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:425.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">examinations and mammary gland</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:435.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">studies to clarify the recommendations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:445.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">regarding these topics. At a meeting</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:455.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">held in July 2008, the VICH Steering</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:465.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Committee endorsed the final guidance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:475.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for industry, (VICH GL43). The guidance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:485.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">announced in this notice finalizes the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:495.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">draft guidance dated May 18, 2007.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:504.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">This guidance document is intended</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:514.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to cover TAS evaluation for any IVPP</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:524.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">used in the following species: Bovine,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:534.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">ovine, caprine, feline, canine, porcine,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:544.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">equine, and poultry (chickens and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:554.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">turkeys). The recommendations in this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:564.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">guidance may not be appropriate for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:574.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">registration by national or regional</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:584.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">authorities of products for use in minor</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:594.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">species or minor uses. The guidance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:604.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">does not provide information for the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:614.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">design of TAS studies in other species,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:624.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">including aquatic animals. For other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:634.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">species and for minor uses, TAS studies</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:644.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">should be designed following national</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:654.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">or regional guidance.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:669.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">III. Significance of Guidance</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:682.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">This guidance document, developed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:692.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">under the VICH process, has been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:702.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">revised to conform to FDA’s good</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:712.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">guidance practices regulation (21 CFR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:722.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">10.115). For example, the document has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:732.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">been designated ‘‘guidance’’ rather than</FONT></FONT></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 Nov<24>2008</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">15:55 Apr 24, 2009</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:162.60pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Jkt 217001</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:201.40pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">PO 00000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:237.65pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Frm 00059</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:276.05pt;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:310.55pt;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:347.15pt;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\27APN1.SGM</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:424.60pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">27APN1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:22.00pt;top:770.40pt;z-index:3;"></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:0.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-1841402117.htm_files\outputfile-1841402117_background0.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:792.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:536.40pt;top:825.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 11.00pt">19097</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:146.25pt;top:826.55pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 10.00pt">Federal Register/Vol. 74, No. 79 /Monday, April 27, 2009 /Notices</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:852.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">‘‘guideline.’’ In addition, guidance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:862.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">documents must not include mandatory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:872.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">language such as ‘‘shall,’’ ‘‘must,’’</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:882.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">‘‘require,’’ or ‘‘requirement,’’ unless</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:892.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA is using these words to describe a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:902.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">statutory or regulatory requirement. The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:912.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">guidance represents agency’s current</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:922.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">thinking on the topic. It does not create</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:932.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">or confer any rights for or on any person</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:942.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and does not operate to bind FDA or the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:952.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">public. An alternative approach may be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:962.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">used if such approach satisfies the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:972.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">requirements of applicable statutes and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:982.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">regulations.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:997.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">IV. Paperwork Reduction Act of 1995</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:1010.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">This guidance refers to previously</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1020.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">approved collections of information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1030.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">found in FDA regulations. These</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1040.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">collections of information are subject to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1050.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">review by the Office of Management and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1060.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Budget (OMB) under the Paperwork</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1070.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Reduction Act of 1995 (44 U.S.C. 3501–</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1080.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">3520). The collections of information in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1090.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">sections 1–5 of the guidance have been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1100.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">approved under OMB control no. 0910–</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1110.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">0032 (expiration date April 30, 2010).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1125.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">V. Comments</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:1139.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Interested persons may submit to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1149.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Division of Dockets Management (see</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1161.00pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">ADDRESSES</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:89.80pt;top:1159.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">) written or electronic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1169.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">comments regarding this document.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1179.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Submit a single copy of electronic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1189.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">comments or two paper copies of any</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1199.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">mailed comments, except that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1209.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">individuals may submit one paper copy.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1219.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Comments are to be identified with the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1229.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">docket number found in brackets in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1239.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">heading of this document. Received</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1249.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">comments may be seen in the Division</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1259.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of Dockets Management between 9 a.m.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1269.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and 4 p.m., Monday through Friday.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1284.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">VI. Electronic Access</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:1298.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Persons with access to the Internet</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1308.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">may obtain the guidance at either </FONT></FONT><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt"><a href="http://">http://</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt"></FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1318.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt"><a href="http://www.fda.gov/cvm">www.fda.gov/cvm</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt"> or </FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt"><a href="http://">http://</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt"></FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1328.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt"><a href="http://www.regulations.gov.">www.regulations.gov</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:53.00pt;top:1342.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Dated: April 20, 2009.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1353.05pt;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:45.00pt;top:1364.05pt;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:45.00pt;top:1373.05pt;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:45.00pt;top:1384.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">[FR Doc. E9–9521 Filed 4–24–09; 8:45 am]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1396.70pt;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:45.00pt;top:1422.85pt;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:1432.85pt;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:1450.85pt;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:1460.85pt;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:1478.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">National Center for Injury Prevention</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1488.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and Control, Initial Review Group,</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1498.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(NCIPC, IRG)</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:1514.30pt;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:1524.30pt;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:222.00pt;top:852.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(Pub. L. 92–463), CDC announces the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:862.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">following meeting of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:873.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">aforementioned review group:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:887.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Times and Dates:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:897.45pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">8 a.m.–8:15 a.m., April 27, 2009 (Open).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:907.25pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">8:15 a.m.–4 p.m., April 27, 2009 (Closed).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:917.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Place: Teleconference, Toll Free Number:</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:926.85pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">(877) 468–4185, Participant Pass code: 447–</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:936.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">5689.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:946.45pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Status: Portions of the meetings will be</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:956.25pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">closed to the public in accordance with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:966.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">provisions set forth in Section 552b(c)(4) and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:975.85pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">(6), Title 5, U.S.C., and the Determination of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:985.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">the Director, Management Analysis and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:995.45pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Services Office, CDC, pursuant to Section</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1005.25pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">10(d) of Public Law 92–463.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:1015.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Purpose: This group is charged with</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1024.85pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">providing advice and guidance to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1034.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Secretary, Department of Health and Human</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1044.45pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Services, and the Director, CDC, concerning</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1054.25pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">the scientific and technical merit of grant and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1064.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">cooperative agreement applications received</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1073.85pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">from academic institutions and other public</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1083.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">and private profit and nonprofit</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1093.45pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">organizations, including State and local</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1103.25pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">government agencies, to conduct specific</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1113.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">injury research that focuses on prevention</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1122.85pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">and control.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:1132.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Matters To Be Discussed: The meeting will</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1142.45pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">include the review, discussion, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1152.25pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">evaluation of applications submitted in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1162.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">response to Fiscal Year 2009 Requests for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1171.85pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Applications related to the following</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1181.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">individual research announcement: CE09–</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1191.45pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">009, Youth Violence Prevention through</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1201.25pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Economic, Environmental, and Policy</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1211.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Change (U01).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:1220.85pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Agenda items are subject to change as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1230.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">priorities dictate.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:1240.45pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Due to programmatic issues that had to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1250.25pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">resolved, the </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 8.00pt">Federal Register </FONT></b><FONT STYLE="font-size: 8.00pt">notice is being</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1260.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">published less than fifteen days before the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1269.85pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">date of the meeting.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:1279.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Contact Person for More Information: Lisa</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1289.45pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">T. Garbarino, B.S., NCIPC, Extramural</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1299.25pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Research Program Office, CDC, 4770 Buford</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1309.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Highway, NE., M/S F62, Atlanta, Georgia</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1318.85pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">30341–3724, </FONT></FONT><FONT COLOR="000000"><i><FONT STYLE="font-size: 8.00pt">Telephone: </FONT></i><FONT STYLE="font-size: 8.00pt">(404) 723–1527.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:1328.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">The Director, Management Analysis and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1338.45pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Services Office has been delegated the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1348.25pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">authority to sign </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 8.00pt">Federal Register </FONT></b><FONT STYLE="font-size: 8.00pt">notices</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1358.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">pertaining to announcements of meetings and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1367.85pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">other committee management activities for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1377.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">both CDC and the Agency for Toxic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1387.45pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Substances and Disease Registry.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:1401.25pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Dated: April 21, 2009.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1413.05pt;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:1424.85pt;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:1434.25pt;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:1443.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Prevention.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1454.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">[FR Doc. E9–9503 Filed 4–24–09; 8:45 am]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1468.10pt;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:399.00pt;top:853.55pt;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:399.00pt;top:863.55pt;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:399.00pt;top:881.55pt;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:399.00pt;top:896.65pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">[Docket No. FDA–2009–N–0664]</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:913.95pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Computational Modeling for</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:923.95pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Cardiovascular Devices; Public</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:933.95pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Workshop</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:949.55pt;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:435.25pt;top:949.30pt;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:399.00pt;top:959.30pt;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:399.00pt;top:971.15pt;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:432.05pt;top:970.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Notice of public workshop.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:987.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The Food and Drug Administration</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:997.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(FDA) is announcing a public workshop</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1007.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">entitled ‘‘Computational Modeling for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1017.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Cardiovascular Devices.’’ FDA is co-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1027.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">sponsoring the conference with the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1037.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">National Heart, Blood and Lung</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1047.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Institute of the National Institutes of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1057.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Health and the National Science</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1067.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Foundation. The purpose of the public</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1077.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">workshop is to facilitate discussion</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1087.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">among FDA and other interested parties</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1097.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">on the use of computational modeling in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1107.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the design, development, and evaluation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1117.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of cardiovascular medical devices.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:1127.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Date and Time: The public workshop</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1137.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">will be held on June 1 and 2, 2009, from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1147.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">8 a.m. to 5 p.m.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:1157.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Location: The public workshop will</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1167.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">be held at the Hilton Washington DC/</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1177.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Rockville Executive Meeting Center,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1187.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">1750 Rockville Pike, Rockville, MD</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1197.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">20852.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:1206.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Contact Person: Donna R. Lochner,</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1216.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Center for Devices and Radiological</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1226.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Health (HFZ–450), Food and Drug</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1236.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Administration, 9200 Corporate Blvd.,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1246.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Rockville, MD 20850, 240–276–4043, e-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1256.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">mail: </FONT></FONT><FONT COLOR="000000"><i><FONT STYLE="font-size: 9.00pt">donna.lochner@fda.hhs.gov</FONT></i><FONT STYLE="font-size: 9.00pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1268.45pt;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:399.00pt;top:1283.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">I. Why Are We Holding This Public</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1293.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Workshop?</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:1306.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The purpose of the public workshop</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1316.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">is to facilitate discussion among FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1326.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and other interested parties on the use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1336.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of computational modeling in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1346.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">cardiovascular device design,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1356.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">development, and evaluation.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1371.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">II. What Are the Topics We Intend to</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1381.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Address at the Public Workshop?</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:1395.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">We hope to discuss a large number of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1405.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">issues at the public workshop,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1415.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">including, but not limited to:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:1422.80pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:417.15pt;top:1425.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Multi-scale modeling.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:1432.50pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:417.15pt;top:1434.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Imaging for cardiovascular device</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1444.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">modeling.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:1452.20pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:417.15pt;top:1454.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Physiologic input data for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1464.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">cardiovascular device modeling.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:1471.90pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:417.15pt;top:1474.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Device-specific issues related to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1484.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">modeling, including a focus on heart</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1494.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">valves, drug-eluting and bare metal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1504.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">stents, endovascular stents, cardiac</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1514.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">rhythm management, and mechanical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1524.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and circulatory support devices.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:25.00pt;top:1559.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">VerDate Nov<24>2008</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:100.30pt;top:1559.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">15:55 Apr 24, 2009</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:162.60pt;top:1559.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Jkt 217001</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:201.40pt;top:1559.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">PO 00000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:237.65pt;top:1559.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Frm 00060</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:276.05pt;top:1559.35pt;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>
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