Document ID: FDA-2007-P-0192-0005
Agency: fda
Document Type: Notice
Title: Determination That MINOCIN (Minocycline Hydrochloride) Capsules Equivalent to 75 Milligrams Base Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Posted Date: 2008-04-24T04:00Z

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<SPAN STYLE="color:#000000;position:absolute;left:536.40pt;top:33.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 11.00pt">11121</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:141.90pt;top:34.55pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 10.00pt">Federal Register/Vol. 73, No. 41 /Friday, February 29, 2008 /Notices</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:60.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">duration of oral presentations to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:70.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">time available. Your comments should</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:80.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">consider the list of topics that we have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:90.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">proposed to the Committee and should</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:99.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">focus on issues specific to those topics.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:109.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The list of research topics to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:119.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">discussed at the meeting will be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:129.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">available on the following Web site</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:139.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">prior to the meeting: </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:149.50pt;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.cms.hhs.gov/mcd/">www.cms.hhs.gov/mcd/</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:159.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">index</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:68.35pt;top:157.10pt;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:72.85pt;top:159.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">list.asp?list</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:119.15pt;top:157.10pt;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:123.65pt;top:159.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">type=mcac. We</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:169.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">require that you declare at the meeting</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:179.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">whether you have any financial</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:189.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">involvement with manufacturers of any</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:199.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">items or services being discussed (or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:209.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">with their competitors).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:218.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The Committee will deliberate openly</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:228.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">on the topics under consideration.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:238.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Interested persons may observe the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:248.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">deliberations, but the Committee will</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:258.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">not hear further comments during this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:268.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">time except at the request of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:278.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">chairperson. The Committee will also</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:288.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allow a 15-minute unscheduled open</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:298.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">public session for any attendee to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:308.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">address issues specific to the topics</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:318.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">under consideration. At the conclusion</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:328.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of the day, the members will vote and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:338.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Committee will make its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:348.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">recommendation(s) to CMS.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:363.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">III. Registration Instructions</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:376.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The Coverage and Analysis Group is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:386.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">coordinating meeting registration. While</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:396.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">there is no registration fee, individuals</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:406.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">must register to attend. You may register</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">by contacting the person listed in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:428.10pt;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></b></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">section of this notice by the deadline</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">listed in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:96.85pt;top:448.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">DATES</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:123.75pt;top:446.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">section of this notice.</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">Please provide your full name (as it</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">appears on your state issued driverís</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">license), address, organization,</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">telephone, fax number(s), and e-mail</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">address.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:505.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">You will receive a registration</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:515.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">confirmation with instructions for your</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:525.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">arrival at the CMS complex. You will be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:535.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">notified if the seating capacity has been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:545.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">reached.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:555.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">This meeting is located on Federal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:565.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">property; therefore, for security reasons,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:575.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">any individuals wishing to attend this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:585.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">meeting must register by the date as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:595.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">specified in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:111.35pt;top:596.50pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">DATES</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:138.20pt;top:595.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">section of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:605.10pt;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:619.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">IV. Security, Building, and Parking</FONT></FONT></b></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"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Guidelines</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:643.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">This meeting will be held in a Federal</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">government building; therefore, Federal</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">security measures are applicable. In</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">planning your arrival time, we</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">recommend that you arrive reasonably</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">early to allow additional time to clear</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">security. Security measures include the</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">following:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:719.90pt;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:63.15pt;top:722.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Presentation of government-issued</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">photographic identification to the</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">Federal Protective Service or Guard</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">Service personnel.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:77.10pt;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:240.15pt;top:79.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Interior and exterior inspection of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:89.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">vehicles (this includes engine and trunk</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:99.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">inspection) at the entrance to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:109.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">grounds. Parking permits and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:119.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">instructions will be issued after the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:129.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">vehicle inspection.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:136.30pt;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:240.15pt;top:138.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Passing through a metal detector</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:148.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and inspection of items brought into the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:158.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">building. We note that all items brought</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:168.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to CMS, whether personal or for the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:178.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">purpose of presentation or to support a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:188.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">presentation, are subject to inspection.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:198.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">We cannot assume responsibility for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:208.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">coordinating the receipt, transfer,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:218.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">transport, storage, set-up, safety, or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:228.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">timely arrival of any personal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:238.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">belongings or items used for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:248.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">presentation or to support a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:258.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">presentation.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:272.25pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Note: Individuals who are not registered in</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:281.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">advance will not be permitted to enter the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:289.85pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">building and will be unable to attend the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:298.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">meeting. The public may not enter the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:307.45pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">building earlier than 30 to 45 minutes prior</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:316.25pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">to the convening of the meeting.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:328.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">All visitors must be escorted in areas</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:338.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">other than the lower and first floor</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:348.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">levels in the Central Building.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:362.25pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Authority: 5 U.S.C. App. 2, section 10(a).</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:373.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">(Catalog of Federal Domestic Assistance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:381.85pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Program No. 93.773, MedicareóHospital</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:390.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Insurance; and Program No. 93.774,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:399.45pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">MedicareóSupplementary Medical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:408.35pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Insurance Program).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:421.25pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Dated: February 14, 2008.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:432.15pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Barry M. Straube,</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:443.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Chief Medical Officer and Director, Office</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:452.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">of Clinical Standards and Quality, Centers</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:461.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">for Medicare and Medicaid Services.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:472.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">[FR Doc. E8ñ3829 Filed 2ñ28ñ08; 8:45 am]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:484.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 6.00pt">BILLING CODE 4120–01–P</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:510.65pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">DEPARTMENT OF HEALTH AND</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:520.65pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">HUMAN SERVICES</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:538.55pt;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:222.00pt;top:553.65pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">[Docket No FDA–2008–P–0125] (formerly</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:562.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Docket No. 2007P–0172)</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:579.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Determination That MINOCIN</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:589.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(Minocycline Hydrochloride) Capsules</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:599.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Equivalent to 75 Milligrams Base Was</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:609.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Not Withdrawn From Sale for Reasons</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:619.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of Safety or Effectiveness</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:634.95pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">AGENCY</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.25pt;top:634.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Food and Drug Administration,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:644.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">HHS.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:656.15pt;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:255.05pt;top:655.90pt;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:222.00pt;top:672.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">SUMMARY</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.65pt;top:672.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The Food and Drug</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:682.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Administration (FDA) is announcing its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:692.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determination that MINOCIN</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:702.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(minocycline hydrochloride) Capsules</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:712.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">equivalent to (EQ) 75 milligrams (mg)</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">base was not withdrawn from sale for</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">reasons of safety or effectiveness. This</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">determination will allow FDA to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:70.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">approve abbreviated new drug</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:80.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">applications (ANDAs) for minocycline</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:90.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">hydrochloride capsules if all other legal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:100.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and regulatory requirements are met.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:112.05pt;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:399.00pt;top:121.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Carol E. Drew, Center for Drug</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:131.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Evaluation and Research, Food and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:141.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Drug Administration, 10903 New</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:151.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Hampshire Ave., Bldg. 51, rm. 6306,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:161.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Silver Spring, MD 20993ñ0002, 301ñ</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:171.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">796</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:414.00pt;top:171.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">–3601.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:183.55pt;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:522.10pt;top:183.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">In 1984,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:193.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Congress enacted the Drug Price</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:203.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Competition and Patent Term</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:213.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Restoration Act of 1984 (Public Law 98ñ</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:223.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">417) (the 1984 amendments), which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:233.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">authorized the approval of duplicate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:243.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">versions of drug products approved</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:253.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">under an ANDA procedure. ANDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:263.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">applicants must, with certain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:273.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">exceptions, show that the drug for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:283.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">which they are seeking approval</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:293.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">contains the same active ingredient in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:303.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the same strength and dosage form as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:313.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the ëëlisted drug,íí which is a version of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:323.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the drug that was previously approved.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:333.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">ANDA applicants do not have to repeat</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:343.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the extensive clinical testing otherwise</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:353.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">necessary to gain approval of a new</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:363.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">drug application (NDA). The only</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:373.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">clinical data required in an ANDA are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:383.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">data to show that the drug that is the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:393.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">subject of the ANDA is bioequivalent to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:403.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the listed drug.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:412.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The 1984 amendments include what</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:422.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">is now section 505(j)(7) of the Federal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:432.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Food, Drug, and Cosmetic Act (21 U.S.C.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:442.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">355(j)(7)), which requires FDA to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:452.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">publish a list of all approved drugs.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:462.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA publishes this list as part of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:472.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">‘‘Approved Drug Products With</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:482.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Therapeutic Equivalence Evaluations,íí</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:492.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">which is known generally as the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:502.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">‘‘Orange Book.’’ Under FDA regulations,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:512.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">drugs are removed from the list if the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:522.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">agency withdraws or suspends approval</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:532.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of the drugís NDA or ANDA for reasons</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:542.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of safety or effectiveness, or if FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:552.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determines that the listed drug was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:562.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">withdrawn from sale for reasons of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:572.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">safety or effectiveness (21 CFR 314.162).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:582.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Regulations also provide that the agency</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:592.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">must make a determination as to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:602.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">whether a listed drug was withdrawn</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:612.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">from sale for reasons of safety or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:622.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">effectiveness before an ANDA that refers</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:632.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to that listed drug may be approved</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:642.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(ß314.161(a)(1) (21 CFR 314.161(a)(1))).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:652.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA may not approve an ANDA that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:662.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">does not refer to a listed drug.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:672.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">On May 1, 2007, Kendle International,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:682.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">on behalf of Aurobindo</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">Pharmaceuticals, Ltd., submitted a</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">citizen petition (Docket No. 2007Pñ</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">0172/CP1) to FDA under 21 CFR 10.30.</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">The petition requests that the agency</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">determine whether MINOCIN</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 Aug<31>2005</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:100.30pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">19:22 Feb 28, 2008</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:163.65pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Jkt 214001</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:202.45pt;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:238.75pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Frm 00034</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:277.15pt;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:311.60pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Sfmt 4703</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:348.25pt;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\29FEN1.SGM</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:425.30pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">29FEN1</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="outputfile1602179000.htm_files\outputfile1602179000_background0.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:792.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:825.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 11.00pt">11122</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:141.90pt;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. 73, No. 41 /Friday, February 29, 2008 /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">(minocycline hydrochloride) Capsules</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:862.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EQ 75 mg base (NDA 050ñ649),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:873.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">manufactured by Triax Pharmaceuticals,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:883.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Ltd. (Triax), was withdrawn from sale</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:893.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for reasons of safety or effectiveness.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:904.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MINOCIN is a tetracycline-class</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:914.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">antibiotic medicine used to treat certain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:925.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">infections caused by bacteria. MINOCIN</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:935.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Capsules EQ 75 mg base was approved</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:945.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">on February 12, 2001. Our records show</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:956.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that the 75 mg strength of this product</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:966.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">was marketed for a short period of time</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:977.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">in 2001. MINOCIN Capsules EQ 75 mg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:987.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">base were discontinued in September</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:997.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2001 and the drug product was moved</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1008.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">from the prescription drug product list</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1018.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to the ëëDiscontinued Drug Product Listíí</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1029.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">section of the Orange Book.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:1042.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA has reviewed its records and,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1052.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">under ß314.161, has determined that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1063.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MINOCIN Capsules EQ 75 mg base was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1073.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">not withdrawn from sale for reasons of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1083.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">safety or effectiveness. The petitioner</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1094.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">identified no data or other information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1104.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">suggesting that MINOCIN Capsules EQ</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1115.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">75 mg base was withdrawn for reasons</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1125.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of safety or effectiveness. FDA has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1135.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">independently evaluated relevant</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1146.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">literature and data for possible</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1156.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">postmarketing adverse events and has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1167.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">found no information that would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1177.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">indicate that this product was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1187.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">withdrawn from sale for reasons of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1198.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">safety or effectiveness. Accordingly, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1208.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">agency will continue to list MINOCIN</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1219.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(minocycline hydrochloride) Capsules</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1229.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EQ 75 mg base in the ëëDiscontinued</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1239.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Drug Product Listíí section of the Orange</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1250.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Book. The ëëDiscontinued Drug Product</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1260.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Listíí delineates, among other items,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1271.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">drug products that have been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1281.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">discontinued from marketing for reasons</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1291.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">other than safety or effectiveness.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1302.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">ANDAs that refer to minocycline</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1312.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">hydrochloride capsules EQ 75 mg base</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1323.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">may be approved by the agency if all</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1333.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">other legal and regulatory requirements</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1343.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for the approval of ANDAs are met. If</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1354.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA determines that labeling for this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1364.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">drug product should be revised to meet</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1375.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">current standards, the agency will</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1385.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">advise ANDA applicants to submit such</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1395.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">labeling.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:53.00pt;top:1410.45pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Dated: February 21, 2008.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1422.25pt;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:1434.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Assistant Commissioner for Policy.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1445.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">[FR Doc. E8ñ3879 Filed 2ñ28ñ08; 8:45 am]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1458.50pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 6.00pt">BILLING CODE 4160–01–S</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top: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:222.00pt;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:222.00pt;top:881.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">National Institutes of Health</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:899.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Submission for OMB Review;</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:909.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Comment Request; Cancer Care for</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:919.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Uninsured Individuals: A Feasibility</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:929.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Study (NCI)</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:944.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Summary: Under the provisions of</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:954.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Section 3507(a)(1)(D) of the Paperwork</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:964.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Reduction Act of 1995, the National</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:974.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Cancer Institute (NCI), the National</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:984.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Institutes of Health (NIH) has submitted</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:994.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to the Office of Management and Budget</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1004.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(OMB) a request to review and approve</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1014.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the information collection listed below.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1024.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">This proposed information collection</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1034.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">was previously published in the </FONT></FONT><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Federal</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1044.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Register on December 21, 2007 (Vol. 72,</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1054.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">No. 245, p. 72741 and allowed 60-days</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1064.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for public comment. One public</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1074.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">comment was received that questioned</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1084.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">why the study was not funded by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1094.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">University of Alabama (UAB) funds. A</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1104.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">response was made on February 8, 2008,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1114.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that indicated that UAB was funding</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1124.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">this study. The National Institutes of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1134.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Health may not conduct or sponsor, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1144.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the respondent is not required to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1154.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">respond to, an information collection</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1164.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that has been extended, revised, or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1174.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">implemented on or after October 1,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1184.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">1995, unless it displays a currently valid</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1194.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">OMB control number.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:1203.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Proposed Collection: Title: Cancer</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1213.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Care For Uninsured Individuals: A</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1223.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Feasibility Study. </FONT></FONT><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Type of Information</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1233.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Collection Request: New. Need and Use</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1243.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of Information Collection: The purpose</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1253.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of this information collection is to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1263.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">assess the feasibility of obtaining health</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1273.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">insurance information for participants</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1283.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of the Prostate, Lung, Colon and Ovarian</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1293.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(PLCO) Cancer Screening Trial</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1303.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">participants from health care providers</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1313.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and self reports. The ultimate objective</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1323.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">is to compare the health care utilization</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1333.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of insured and uninsured PLCO</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1343.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">participants. The PLCO data provides a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1353.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">unique opportunity to study health care</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1363.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">seeking behavior after an abnormal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1373.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">cancer screening test and the effect of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1383.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">lack of health insurance. Participants</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1393.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">who had positive cancer screening tests</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1403.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">were referred to their doctors for follow-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1413.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">up care. No additional care was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1423.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">provided by the trial. The study</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1433.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">collected detailed information on tests</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1443.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">received for diagnosis, clinical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1453.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">presentation of disease, and cancer</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1463.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">treatment. Since the PLCO original data</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1473.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">collection had not recorded the health</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1483.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">insurance of participants at the time of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1493.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">their screening, it is necessary to collect</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:852.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">it retrospectively. This feasibility study</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:862.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">will request information from 50</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:872.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">physicians and 150 participants. The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:882.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">aims are to determine the:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:892.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(1) Total number of physicians to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:902.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">contacted to obtain insurance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:912.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information on all PLCO participants</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:922.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">who had a positive cancer screening</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:932.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">test;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:942.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(2) Percentage of physicians willing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:952.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and able to provide insurance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:962.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:972.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(3) Percentage of participants with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:982.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and without insurance;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:992.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(4) Number of participants for whom</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1002.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">insurance status can be only determined</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1012.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">by self report;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:1023.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(5) Percentage of PLCO participants</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1033.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">who accept to respond to the survey;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:1043.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(6) Percentage of individuals who are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1053.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">willing to provide information on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1063.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">insurance status; and,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:1073.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(7) Potential proportion of PLCO</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1083.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">participants without health insurance.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:1093.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">These results will be used to design</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1103.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">a study to examine the health care</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1113.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">behavior of insured and uninsured</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1123.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">PLCO participants. This is relevant to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1133.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">understand the results of the PLCO</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1143.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Cancer Screening Trial and other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1153.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">screening trials currently being</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1163.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">conducted in the U.S. The success of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1173.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">these trials is conditional on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1183.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">participantsí access to care following a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1193.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">recommendation for follow-up.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1203.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Uninsured individuals may be more</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1213.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">likely to join these trials than insured</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1223.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">ones in order to get free preventive care.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1233.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">They may also be more likely to not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1243.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">seek, or delay seeking, care after an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1253.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">abnormal screening test even though</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1263.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">they are encouraged to get care and they</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1273.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">may be highly motivated to receive the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1283.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">best care possible. It is relevant for other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1293.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">decision makers to understand whether</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1303.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">uninsured persons are receiving</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1313.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">appropriate care after abnormal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1323.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">screening results. The efforts to control</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1333.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">cancer disease and the loss of life</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1343.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">associated with it are concentrated on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1353.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">population wide screening. These</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1363.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">endeavors may be compromised if a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1373.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">significant proportion of the population</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1383.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">does not get appropriate follow-up after</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1393.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">screening or does not get the care</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1403.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">known to be effective for their disease.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1413.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Frequency of Response: One time.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1423.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Affected Public: Individuals and</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1433.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">households; businesses or other for-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1443.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">profit. </FONT></FONT><FONT COLOR="000000"><i><FONT STYLE="font-size: 9.00pt">Type of Respondents: </FONT></i><FONT STYLE="font-size: 9.00pt">Individuals</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1453.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">older than 55 who participated in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1463.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">PLCO Screening trial and physicians</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1473.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">who provided care for them. The annual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1483.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">reporting burden is shown in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1493.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">following table.</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 Aug<31>2005</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">19:22 Feb 28, 2008</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:163.65pt;top:1559.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Jkt 214001</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:202.45pt;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:238.75pt;top:1559.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Frm 00035</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:277.15pt;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>
<SPAN STYLE="color:#000000;position:absolute;left:311.60pt;top:1559.35pt;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>
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