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<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:33.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 11.00pt">196</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:138.90pt;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. 1 /Wednesday, January 2, 2008 /Notices</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:53.00pt;top:60.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Dated: December 26, 2007.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:71.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Jeffrey Shuren,</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:82.05pt;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:93.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">[FR Doc. 07ñ6268 Filed 12ñ27ñ07; 3:08 pm]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:105.70pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 6.00pt">BILLING CODE 4160–01–S</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:131.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">DEPARTMENT OF HEALTH AND</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:141.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">HUMAN SERVICES</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:159.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Food and Drug Administration</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:175.95pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">[Docket No. 2007D– 0496]</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:193.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Draft Guidance for Industry on</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:203.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Questions and Answers Regarding the</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:213.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Labeling of Nonprescription Human</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:223.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Drug Products Marketed Without an</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:233.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Approved Application as Required by</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:243.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Dietary Supplement and</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:253.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Nonprescription Drug Consumer</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:263.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Protection Act; Availability</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:279.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">AGENCY</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:81.25pt;top:279.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Food and Drug Administration,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:289.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">HHS.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:301.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">ACTION</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:78.05pt;top:301.00pt;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:318.55pt;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:87.65pt;top:318.30pt;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:45.00pt;top:328.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Administration (FDA) is announcing the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:338.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">availability of a draft guidance entitled</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:348.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">‘‘Questions and Answers Regarding the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:358.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Labeling of Nonprescription Human</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:368.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Drug Products Marketed Without an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:378.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Approved Application as Required by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:388.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Dietary Supplement and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:398.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Nonprescription Drug Consumer</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:408.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Protection Act.íí This draft guidance is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:418.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">intended to assist industry in complying</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:428.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">with the labeling requirements for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:438.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">nonprescription (over-the-counter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:448.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(OTC)) human drugs marketed without</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:458.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">an approved application established by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:468.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Dietary Supplement and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:478.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Nonprescription Drug Consumer</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:488.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Protection Act. Separate guidance,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:498.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">issued by the Center for Food Safety and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:508.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Applied Nutrition on labeling</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:518.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">requirements for dietary supplements, is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:528.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">announced elsewhere in this issue of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:538.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 9.00pt">Federal Register</FONT></b><FONT STYLE="font-size: 9.00pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:550.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">DATES</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:74.85pt;top:550.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Although you can comment on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:560.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">any guidance at any time (see 21 CFR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:570.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">10.115(g)(5)), to ensure that the agency</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:580.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">considers your comments on this draft</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:590.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">guidance before it begins work on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:600.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">final version of the guidance, submit</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:610.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">written or electronic comments on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:620.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">draft guidance, including comments</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:630.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">regarding proposed collection of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:640.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information, by March 3, 2008.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:652.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">ADDRESSES</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.25pt;top:652.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Submit written requests for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:662.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">single copies of the draft guidance to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:672.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Division of Drug Information (HFDñ</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:682.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">240), Center for Drug Evaluation and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:692.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Research, Food and Drug</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:702.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Administration, 5600 Fishers Lane,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:712.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Rockville, MD 20857. Send one self-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:722.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">addressed adhesive label to assist that</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">office in processing your requests.</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">Submit written comments on the draft</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">guidance to the Division of Dockets</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:80.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Management (HFAñ305), Food and Drug</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:90.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Administration, addressStreet5630</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:100.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Fishers Lane, rm. 1061,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:110.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">placeCityRockville, StateMD</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:120.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">PostalCode20852. Submit electronic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:130.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">comments to </FONT></FONT><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt"><a href="http://www.fda.gov/">http://www.fda.gov/</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt"></FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:140.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">dockets/ecomments or </FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt"><a href="http://">http://</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt"></FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:150.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt"><a href="http://www.regulations.gov.">www.regulations.gov</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">. See the</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:161.70pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">SUPPLEMENTARY INFORMATION</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.10pt;top:160.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">section for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:170.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">electronic access to the draft guidance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:180.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">document.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:193.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">FOR FURTHER INFORMATION CONTACT</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:203.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Walter Ellenberg, Center for Drug</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:213.50pt;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:222.00pt;top:223.50pt;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:222.00pt;top:233.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Hampshire Ave., Bldg. 22, rm. 5488,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:243.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Silver Spring, MD 20993, 301ñ796ñ</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:253.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2090.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:266.95pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">SUPPLEMENTARY INFORMATION</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:281.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">I. Background</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:294.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA is announcing the availability of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:304.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">a draft guidance entitled ëëQuestions and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:314.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Answers Regarding the Labeling of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:324.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Nonprescription Human Drug Products</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:334.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Marketed Without an Approved</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:344.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Application as Required by the Dietary</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:354.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Supplement and Nonprescription Drug</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:364.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Consumer Protection Act.íí On</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:374.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">December 22, 2006, the President signed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:384.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">into law the Dietary Supplement and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:394.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Nonprescription Drug Consumer</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:404.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Protection Act (Public Law 109ñ462,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:414.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">120 Stat. 3469). This law amends the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:424.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Federal Food, Drug, and Cosmetic Act</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:434.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(the act) with respect to serious adverse</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:444.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">event reporting for dietary supplements</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:454.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and nonprescription drugs marketed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:464.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">without an approved application. The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:474.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">draft guidance document contains</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:484.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">questions and answers relating to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:494.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">new labeling requirements under Public</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:504.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Law 109ñ462 for OTC drugs marketed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:514.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">without an approved application.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:524.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">This draft guidance is being issued</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:534.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">consistent with FDAís good guidance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:544.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">practices regulation (21 CFR 10.115).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:554.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The draft guidance, when finalized, will</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:564.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">represent the agencyís current thinking</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:574.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">on this topic. It does not create or confer</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:584.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">any rights for or on any person and does</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:594.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">not operate to bind FDA or the public.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:604.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">An alternative approach may be used if</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:614.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">such approach satisfies the requirement</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:624.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of the applicable statutes and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:634.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">regulations.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:649.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">II. Comments</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:662.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Interested persons may submit to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:672.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Division of Dockets Management (see</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:683.70pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">ADDRESSES</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:266.80pt;top:682.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">) written or electronic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left: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">comments regarding this document.</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">Submit a single copy of electronic</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">comments or two paper copies of any</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">mailed comments, except that</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">individuals may submit one copy.</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">Comments are to be identified with the</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">docket number found in brackets in the</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">heading of this document. Received</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">comments may be seen in the Division</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">of Dockets Management between 9 a.m.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:110.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and 4 p.m., Monday through Friday.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:121.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Please note that in January 2008, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:131.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA Web site is expected to transition</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:141.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to the Federal Dockets Management</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:151.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">System (FDMS). FDMS is a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:161.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Government-wide, electronic docket</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:171.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">management system. After the transition</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:181.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">date, electronic submissions will be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:191.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">accepted by FDA through the FDMS</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:201.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">only. When the exact date of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:211.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">transition to FDMS is known, FDA will</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:221.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">publish a </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 9.00pt">Federal Register </FONT></b><FONT STYLE="font-size: 9.00pt">notice</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:231.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">announcing that date.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:246.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">III. Paperwork Reduction Act of 1995</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:260.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Under the Paperwork Reduction Act</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:270.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of 1995 (the PRA) (44 U.S.C. 3501ñ</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:280.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">3520), Federal agencies must obtain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:290.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">approval from the Office of Management</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:300.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and Budget (OMB) for each collection of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:310.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information they conduct or sponsor.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:320.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">‘‘Collection of information’’ is defined</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:330.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">in 44 U.S.C. 3502(3) and 5 CFR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:340.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">1320.3(c) and includes agency requests</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:350.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">or requirements that members of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:360.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">public submit reports, keep records, or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:370.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">provide information to a third party.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:380.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Section 3506(c)(2)(A) of the PRA (44</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:390.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">U.S.C. 3506(c)(2)(A)) requires Federal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:400.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">agencies to provide a 60-day notice in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:410.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 9.00pt">Federal Register </FONT></b><FONT STYLE="font-size: 9.00pt">concerning each</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:420.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">proposed collection of information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:430.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">before submitting the collection to OMB</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:440.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for approval. To comply with this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:450.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">requirement, FDA is publishing notice</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:460.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of the proposed collection of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:470.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information set forth as follows.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:481.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">With respect to the following</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:491.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">collection of information, FDA invites</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:501.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">comment on the following: (1) Whether</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:511.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the proposed collection of information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:521.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">is necessary for the proper performance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:531.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of FDAís functions, including whether</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:541.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the information will have practical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:551.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">utility; (2) the accuracy of FDAís</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:561.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">estimate of the burden of the proposed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:571.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">collection of information, including the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:581.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">validity of the methodology and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:591.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">assumptions used; (3) ways to enhance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:601.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the quality, utility, and clarity of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:611.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information to be collected; and (4)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:621.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">ways to minimize the burden of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:631.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">collection on respondents, including</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:641.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">through the use of automated collection</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:651.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">techniques, when appropriate, and other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:661.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">forms of information technology.</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"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Title: Labeling Requirements and</FONT></FONT></i></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">Recommendations under the Dietary</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">Supplement and Nonprescription Drug</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">Consumer Protection Act for</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">Nonprescription Drug Products</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">Marketed Without an Approved</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">Application.</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">19:07 Dec 31, 2007</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:164.05pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Jkt 214001</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:202.85pt;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:239.10pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Frm 00050</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:277.50pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Fmt 4703</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:312.00pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Sfmt 4703</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:348.60pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">E:\FR\FM\02JAN1.SGM</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:424.95pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">02JAN1</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="outputfile1483252555.htm_files\outputfile1483252555_background0.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:792.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:548.65pt;top:825.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 11.00pt">197</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:138.90pt;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. 1 /Wednesday, January 2, 2008 /Notices</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:852.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Description of Respondents:</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:862.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Respondents to this collection of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:872.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information are manufacturers, packers,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:882.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and distributors whose name (under</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:892.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">section 502(b)(1) of the act) appears on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:902.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the label of a nonprescription drug</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:912.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">marketed in the United States.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:921.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Burden Estimate: FDA is requesting</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:931.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">public comment on the estimated one-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:941.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">time reporting burden from these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:951.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">respondents, as required by Public Law</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:961.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">109</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.00pt;top:961.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">–462 and described in the draft</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:971.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">guidance. This guidance document</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:981.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">discusses the labeling requirements of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:991.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">section 502(x) of the act (21 U.S.C.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1001.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">352(x)), which was added by Public Law</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1011.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">109</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.00pt;top:1011.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">–462.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:1020.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Section 502(x) of the act requires the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1030.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">label of an OTC drug product marketed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1040.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">without an approved application in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1050.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">United States to include a domestic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:852.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">address or domestic phone number</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:862.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">through which the responsible person</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:872.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">may receive a report of a serious adverse</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:882.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">event associated with the product. If the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:891.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">label does not include the required</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:901.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">domestic address or phone number, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:911.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">drug product is misbranded. When the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:921.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">responsible person chooses to provide a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:931.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">domestic address (rather than a phone</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:941.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">number) for adverse event reporting,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:951.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA concludes that the statute requires</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:961.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the product label to bear a full U.S.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:971.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">mailing address that includes the street</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:981.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">address or P.O. Box, city, state, and zip</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:990.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">code of the responsible person (i.e., the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1000.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">manufacturer, packer, distributor, or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1010.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">retailer whose name appears on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1020.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">label). This labeling requirement helps</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1030.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to ensure that any mailed adverse event</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1040.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">report will reach the responsible person.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1050.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Similarly, when the responsible person</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">chooses to provide a domestic phone</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:862.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">number for adverse event reporting,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:872.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA concludes that the statute requires</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:882.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the phone number on the product label</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:892.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to include the area code. Without the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:903.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">area code, the phone number is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:913.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">incomplete and does not serve its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:923.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">intended purpose of enabling the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:933.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">consumer to contact the responsible</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:943.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">person to report a serious adverse event.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:956.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">In addition to discussing the statutory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:966.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">requirement that labels include a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:976.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">domestic address or a domestic phone</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:986.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">number, the draft guidance includes</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:997.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">recommendations about the location of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1007.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">this information on the label and the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1017.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">recommendation that the label make</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1027.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">clear the purpose of this information.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:1040.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA estimates the burden of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1050.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">collection of information as follows:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:187.85pt;top:1068.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.00pt">T</FONT><FONT STYLE="font-size: 8.19pt">ABLE </FONT><FONT STYLE="font-size: 10.00pt">1.óE</FONT><FONT STYLE="font-size: 8.19pt">STIMATED </FONT><FONT STYLE="font-size: 10.00pt">O</FONT><FONT STYLE="font-size: 8.19pt">NE</FONT><FONT STYLE="font-size: 10.00pt">-T</FONT><FONT STYLE="font-size: 8.19pt">IME </FONT><FONT STYLE="font-size: 10.00pt">R</FONT><FONT STYLE="font-size: 8.19pt">EPORTING </FONT><FONT STYLE="font-size: 10.00pt">B</FONT><FONT STYLE="font-size: 8.19pt">URDEN</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:419.80pt;top:1067.95pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.50pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:289.40pt;top:1088.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">No. of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:276.75pt;top:1096.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Respondents</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:343.60pt;top:1088.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Frequency</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:337.35pt;top:1096.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">per Response</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:415.75pt;top:1088.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Total</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:404.60pt;top:1096.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Responses</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:468.60pt;top:1088.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Hours Per</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:468.80pt;top:1096.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Response</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:523.60pt;top:1092.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Total Hours</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.30pt;top:1113.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Domestic address or phone number labeling requirement (21</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:53.30pt;top:1122.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">U.S.C. 502(x)) and recommendation to clarify its purpose</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:313.90pt;top:1122.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">200</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:376.05pt;top:1122.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">500</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:422.65pt;top:1122.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">100,000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:509.30pt;top:1122.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:538.10pt;top:1122.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">400,000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:53.00pt;top:1137.40pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.20pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:57.80pt;top:1137.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">There are no capital costs or maintenance and operating costs associated with this collection of information.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:1164.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">As indicated in Table 1 of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1174.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">document, we estimate that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1184.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">approximately 200 manufacturers will</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1195.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">revise approximately 100,000 labels</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1205.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">total to add a full domestic address and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1216.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">a domestic telephone number, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1226.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">should they choose to adopt the draft</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1236.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">guidanceís recommendation, to add a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1247.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">statement identifying the purpose of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1257.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">domestic address or telephone number.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1268.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">We specifically request comments on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1278.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">these estimates. FDA believes that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1288.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">designing the label change should not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1299.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">take longer than 4 hours per label.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1309.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Automated printing of the labels should</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1320.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">only require a few seconds per label.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1335.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">IV. Comments</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:1353.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Interested persons may submit to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1363.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Division of Dockets Management (see</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1375.20pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">ADDRESSES</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:89.80pt;top:1373.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">) written or electronic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1384.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">comments regarding the draft guidance,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1394.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">including comments regarding proposed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1405.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">collection of information. Submit a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1415.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">single copy of electronic comments or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1425.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">two paper copies of any mailed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1436.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">comments, except that individuals may</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1446.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">submit one paper copy. Comments are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1457.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to be identified with the docket number</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1467.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">found in brackets in the heading of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1477.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">document. The draft guidance and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1488.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">received comments are available for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1498.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">public examination in the Division of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1509.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Dockets Management between 9 a.m.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1519.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and 4 p.m., Monday through Friday.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1164.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">V. Electronic Access</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:1177.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Persons with access to the Internet</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1187.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">may obtain the document at either</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1197.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt"><a href="http://www.fda.gov/cder/guidance/">http://www.fda.gov/cder/guidance/</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt"></FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1207.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">index.htm or </FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt"><a href="http://www.fda.gov/">http://www.fda.gov/</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt"></FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1217.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">ohrms/dockets/default.htm.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:1230.75pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Dated: December 26, 2007.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1241.55pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Jeffrey Shuren,</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1252.35pt;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:222.00pt;top:1263.35pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">[FR Doc. 07ñ6267 Filed 12ñ27ñ07; 3:08 pm]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1275.80pt;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:1301.75pt;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:1311.75pt;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:1329.55pt;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:1344.65pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">[Docket No. 2007D–0491]</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1361.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Draft Guidance for Industry: Questions</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1371.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and Answers Regarding the Labeling</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1381.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of Dietary Supplements as Required by</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1391.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Dietary Supplement and</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1401.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Nonprescription Drug Consumer</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1411.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Protection Act; Availability</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1426.95pt;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:1426.70pt;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:1436.70pt;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:1448.15pt;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:1447.90pt;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:1464.55pt;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:1464.30pt;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:1474.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Administration (FDA) is announcing the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1484.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">availability of a draft guidance entitled</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1494.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">‘‘Questions and Answers Regarding the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1504.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Labeling of Dietary Supplements as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1514.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Required by the Dietary Supplement</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1524.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and Nonprescription Drug Consumer</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1164.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Protection Act.íí This draft guidance is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1174.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">intended to assist the dietary</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1184.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">supplement industry in complying with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1194.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the labeling requirements prescribed for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1205.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">dietary supplement manufacturers,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1215.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">packers, and distributors by the Dietary</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1225.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Supplement and Nonprescription Drug</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1236.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Consumer Protection Act (the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1246.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">DSNDCPA). Separate guidance, issued</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1256.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">by the Center for Drug Evaluation and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1267.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Research on labeling requirements for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1277.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">nonprescription (over-the-counter)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1287.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">human drugs marketed without an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1297.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">approved application, is announced</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1308.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">elsewhere in this issue of 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:399.00pt;top:1318.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Register.</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1335.95pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">DATES</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:428.85pt;top:1335.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Although you can comment on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1345.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">any guidance at any time (see 21 CFR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1356.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">10.115(g)(5)), to ensure that the agency</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1366.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">considers your comment on this draft</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1376.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">guidance before it begins work on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1386.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">final version of the guidance, submit</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1396.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">written or electronic comments on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1407.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">draft guidance by March 3, 2008.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1422.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">ADDRESSES</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:449.25pt;top:1422.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Submit written requests for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1432.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">single copies of the draft guidance to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1442.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Office of Nutritional Products, Labeling,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1452.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and Dietary Supplements (HFSñ800),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1463.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Food and Drug Administration, 5100</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">Paint Branch Pkwy., College Park, MD</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1483.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">20740. Send one self-addressed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1493.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">adhesive label to assist the office in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1503.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">processing your request, or include a fax</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1514.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">number to which the draft guidance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1524.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">may be sent. See the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:485.30pt;top:1525.70pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">SUPPLEMENTARY</FONT></FONT></b></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">19:07 Dec 31, 2007</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:164.05pt;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:202.85pt;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:239.10pt;top:1559.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Frm 00051</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:277.50pt;top:1559.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Fmt 4703</FONT></FONT></FONT></SPAN>
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<SPAN STYLE="color:#000000;position:absolute;left:348.60pt;top:1559.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">E:\FR\FM\02JAN1.SGM</FONT></FONT></FONT></SPAN>
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