Document ID: FDA-2008-D-0609-0002
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-12-03T05:00Z

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<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:0.00pt;z-index:-1;"><img style="width:652pt;height:918pt;" src="outputfile-1811876798.htm_files\outputfile-1811876798_background0.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:918.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:94.10pt;top:992.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 48.00pt">Guidance for Industry</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:152.95pt;top:1088.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 36.00pt">Submission of Patent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:105.50pt;top:1129.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 36.00pt">Information for Certain Old</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:226.00pt;top:1170.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 36.00pt">Antibiotics</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.70pt;top:1303.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Additional copies are available from:</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:253.45pt;top:1314.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Office of Communications</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:225.00pt;top:1326.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Division of Drug Information, HFD-240</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:221.70pt;top:1337.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Center for Drug Evaluation and Research</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:243.60pt;top:1349.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Food and Drug Administration</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.60pt;top:1360.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">1</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:253.65pt;top:1360.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">090</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:268.65pt;top:1360.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">3 New Hampshire Ave.,</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:263.60pt;top:1372.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Bldg. 51, Room 2201</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:242.75pt;top:1383.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Silver Spring, MD 20993-0002</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:266.65pt;top:1395.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">(Tel) 301-796-3400</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:217.95pt;top:1406.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt"></FONT></FONT></i><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt"><a href="http://www.fda.gov/cder/guidance/index.htm">http://www.fda</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">.</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt"><a href="http://www.fda.gov/cder/guidance/index.htm">gov/cder/gu</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">i</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt"><a href="http://www.fda.gov/cder/guidance/index.htm">dance/index.h</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">t</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt"><a href="http://www.fda.gov/cder/guidance/index.htm">m</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt"></FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:183.00pt;top:1514.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">U.S. Department of Health and Human Services</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:226.15pt;top:1528.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Food and Drug Administration</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:176.05pt;top:1542.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Center for Drug Evaluation and Research (CDER)</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:277.30pt;top:1570.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Procedural</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.30pt;top:1597.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">November 2008</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:1710.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:205.25pt;top:1746.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><i><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Contains Nonbinding Recommendations</FONT></FONT></i></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:241.20pt;top:1766.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Draft — Not for Implementation</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:241.30pt;top:1825.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">TABLE OF CONTENTS</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:1866.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I.</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:1866.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">INTRODUCTION............................................................................................................. 1</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:1886.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">II.</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:1886.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">BACKGROUND ............................................................................................................... 1</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:1906.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">III.</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:1906.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">QUESTIONS AND ANSWERS....................................................................................... 2</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:304.30pt;top:2452.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">i</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:2502.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:205.25pt;top:2538.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><i><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Contains Nonbinding Recommendations</FONT></FONT></i></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:241.20pt;top:2558.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Draft — Not for Implementation</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:48.00pt;top:2573.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:48.00pt;top:2590.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:48.00pt;top:2603.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:48.00pt;top:2620.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:48.00pt;top:2635.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:226.20pt;top:2587.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 16.02pt">Guidance for Industry</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:380.50pt;top:2584.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 10.50pt">1</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.50pt;top:2617.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 16.02pt">Submission of Patent Information for Certain Old Antibiotics</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:2648pt;width: 1pt;height: 5pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:2648pt;width: 5pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:65pt;top:2654pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:65pt;top:2654pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:66pt;top:2648pt;width:478pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:66pt;top:2654pt;width:478pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:550pt;top:2648pt;width: 1pt;height: 5pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:545pt;top:2648pt;width: 5pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:545pt;top:2654pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:545pt;top:2654pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:2654pt;width: 1pt;height:13pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:65pt;top:2654pt;width: 1pt;height:13pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:550pt;top:2654pt;width: 1pt;height:13pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:545pt;top:2654pt;width: 1pt;height:13pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:48.00pt;top:2655.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:48.00pt;top:2668.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:2668.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.98pt">This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:2668pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:65pt;top:2668pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:550pt;top:2668pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:545pt;top:2668pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:48.00pt;top:2680.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">8</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:2681.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.98pt">thinking on this topic.  It does not create or confer any rights for or on any person and does not operate to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:2681pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:65pt;top:2681pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:550pt;top:2681pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:545pt;top:2681pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:48.00pt;top:2693.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:2694.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.98pt">bind FDA or the public.  You can use an alternative approach if the approach satisfies the requirements of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:2693pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:65pt;top:2693pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:550pt;top:2693pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:545pt;top:2693pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:2705.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:2706.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.98pt">the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:2706pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:65pt;top:2706pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:550pt;top:2706pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:545pt;top:2706pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:2718.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">11</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:2719.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.98pt">staff responsible for implementing this guidance.  If you cannot identify the appropriate FDA staff, call</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:2719pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:65pt;top:2719pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:550pt;top:2719pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:545pt;top:2719pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:2731.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">12</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:2732.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.98pt">the appropriate number listed on the title page of this guidance.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:2731pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:65pt;top:2731pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:550pt;top:2731pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:545pt;top:2731pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:2758pt;width: 1pt;height: 5pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:2763pt;width: 5pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:65pt;top:2758pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:65pt;top:2758pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:66pt;top:2763pt;width:478pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:66pt;top:2758pt;width:478pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:550pt;top:2758pt;width: 1pt;height: 5pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:545pt;top:2763pt;width: 5pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:545pt;top:2758pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:545pt;top:2758pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:2744pt;width: 1pt;height:13pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:65pt;top:2744pt;width: 1pt;height:13pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:550pt;top:2744pt;width: 1pt;height:13pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:545pt;top:2744pt;width: 1pt;height:13pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:2744.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">13</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:2764.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">14</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:2778.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">15</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:2792.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">16</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:2805.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">17</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:2819.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">18</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:2833.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">19</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:2847.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">20</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:2861.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">21</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:2874.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">22</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:2888.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">23</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:2902.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">24</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:2916.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">25</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:2930.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">26</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:2943.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">27</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:2957.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">28</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:2971.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">29</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:2985.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">30</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:2999.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">31</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3012.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">32</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3026.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">33</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3040.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">34</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3054.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">35</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3068.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">36</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3081.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">37</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3095.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">38</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3109.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">39</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3123.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">40</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3137.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">41</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3150.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">42</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3164.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">43</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:2792.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I. INTRODUCTION</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:2819.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This guidance describes the Food and Drug Administration’s (FDA’s or the Agency’s) current</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:2833.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">thinking on the implementation of section 4(b)(1) of the Q1 Program Supplemental Funding Act</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:2847.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">(Public Law 110-379) (the Q1 Act).  It describes which sponsors of new drug applications</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:2861.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">(NDAs) must submit patent information to the Agency under section 4(b)(1) of the Q1 Act.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:2888.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">FDA’s guidance documents, including this guidance, do not establish legally enforceable</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:2902.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">responsibilities.  Instead, guidances describe the Agency’s current thinking on a topic and should</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:2916.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">be viewed only as recommendations, unless specific regulatory or statutory requirements are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:2930.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">cited.  The use of the word </FONT></FONT><FONT COLOR="000000"><i><FONT STYLE="font-size: 12.00pt">should </FONT></i><FONT STYLE="font-size: 12.00pt">in Agency guidances means that something is suggested or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:2943.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">recommended, but not required.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:2985.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">II. BACKGROUND</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3012.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Prior to the enactment of the Food and Drug Modernization Act of 1997 (FDAMA) on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3026.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">November 21, 1997, the FDA approved antibiotic drug marketing applications under section 507</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3040.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).  Applications approved under</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3054.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">section 507 were not subject to Title I of the Drug Price Competition and Patent Term</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3068.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Restoration Act of 1984 (Public Law 98-417)(Hatch-Waxman Amendments), which governs,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3081.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">among other things, patent listings and marketing exclusivity.  Section 125 of FDAMA repealed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3095.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">section 507 and provided that applications for the marketing of  antibiotic drugs that were</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3109.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">approved under section 507, as in effect on the day before the date of enactment of FDAMA,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3123.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">were to be considered to be applications submitted, filed, and approved under section 505 of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3137.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">FD&C Act (21 U.S.C. 355).  However, section 125(d)(2) of FDAMA exempted from certain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3150.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">patent listing, patent certification, and marketing exclusivity provisions of sections 505(c) and (j)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3164.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of the FD&C Act, marketing applications for drugs that contain an antibiotic that was the subject</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:72pt;top:3199pt;width:144pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3206.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.48pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:77.75pt;top:3208.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">This guidance has been prepared by the Antibiotic Working Group in the Center for Drug Evaluation and Research</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3219.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">(CDER) at the Food and Drug Administration.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:303.50pt;top:3244.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">1</FONT></FONT></FONT></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:2502.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-1811876798.htm_files\outputfile-1811876798_background3.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:3294.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:205.25pt;top:3330.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><i><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Contains Nonbinding Recommendations</FONT></FONT></i></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:241.20pt;top:3350.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Draft — Not for Implementation</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3367.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">44</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3381.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">45</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3395.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">46</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3409.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">47</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3422.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">48</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3451.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">50</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3465.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">51</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3493.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">53</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3507.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">54</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3521.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">55</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3534.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">56</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3548.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">57</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3562.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">58</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3576.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">59</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3590.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">60</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3603.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">61</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3617.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">62</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3631.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">63</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3645.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">64</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3659.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">65</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3672.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">66</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3686.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">67</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3700.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">68</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3713.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">69</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3726.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">70</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3738.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">71</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3751.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">72</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3764.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">73</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3776.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">74</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3790.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">75</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3804.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">76</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3817.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">77</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3831.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">78</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3845.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">79</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3859.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">80</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3873.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">81</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3886.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">82</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3900.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">83</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3914.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">84</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3928.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">85</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3942.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">86</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3955.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">87</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3969.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">88</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3367.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of any marketing application received by the Secretary on or before November 20, 1997</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3381.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">(referred to in this guidance as an </FONT></FONT><FONT COLOR="000000"><i><FONT STYLE="font-size: 12.00pt">old </FONT></i><FONT STYLE="font-size: 12.00pt">antibiotic).  In general, NDAs containing old antibiotics</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3395.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">can be identified by NDA numbers that are in the 50,000 series.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3422.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Section 4 of the Q1 Act contains two subsections:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3436.15pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:3437.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The first (section 4(a)) amends section 505 of the FD&C Act to add substantive requirements</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3437.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">49</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:3451.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">regarding patent listing, patent certification, patent term extension, and exclusivity for NDAs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:3465.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that contain old antibiotics.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3478.40pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:3479.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The second (section 4(b)) contains deadlines for submitting certain patent information and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:3479.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">52</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:3493.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">patent certifications.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3521.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Section 4(a) of the Q1 Act amends section 505 of the FD&C Act by adding subsection (v), which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3534.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">establishes, among other things, certain conditions under which the patent listing, patent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3548.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">certification, and marketing exclusivity provisions of sections 505(c) and (j), and the patent term</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3562.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">extension provisions of 35 U.S.C. 156 apply to marketing applications for drugs that contain an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3576.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">old antibiotic.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3603.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Section 4(b) of the Q1 Act (the transitional rules) provides for the submission of the patent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3617.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">information by certain sponsors of NDAs, the publication of such patent information by FDA,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3631.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and the certification to such patents by applicants of pending abbreviated new drug applications</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3645.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">(ANDAs) in order to be deemed “a first applicant” (as defined in section 505(j)(5)(B)(iv) of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3659.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">FD&C Act), not later than 60, 90, and 120 days after enactment of the Q1 Act, respectively.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3686.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Specifically, section 4(b)(1) of the Q1 Act provides that:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:3714.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.98pt">[w]ith respect to a patent issued on or before the enactment of this [Q1] Act, any patent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:3727.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.98pt">information required to be filed with the Secretary of Health and Human Services under</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:3739.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.98pt">subsection (b)(1) or (c)(2) of section 505 of the Federal Food, Drug, and Cosmetic Act</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:3752.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.98pt">(21 U.S.C. 355) to be listed on a drug to which subsection (v)(1) of such section 505 (as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:3764.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.98pt">added by this section) applies shall be filed with the Secretary not later than 60 days after</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:3777.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.98pt">the date of enactment of this [Q1] Act</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3804.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This guidance describes the Agency’s current thinking on the implementation of section 4(b)(1)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3817.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of the Q1 Act and addresses which sponsors of NDAs must submit patent information to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3831.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Agency under section 4(b)(1).  The guidance does not address FDA’s interpretation of the scope</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3845.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of, and procedural requirements associated with, new section 505(v) of the FD&C Act, as added</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3859.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">by the Q1 Act.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3900.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">III.</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.95pt;top:3900.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">QUESTIONS AND ANSWERS</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3928.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><i><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Q1:</FONT></FONT></i></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.05pt;top:3928.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><i><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">What are the relevant dates for implementation of section 4(b)(1) of the Q1 Act?</FONT></FONT></i></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:3955.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">A1:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:3955.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The “date of the enactment of the Q1 Act” is October 8, 2008.  Therefore, “before the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:3969.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">date of the enactment of the Q1 Act” means on or before October 7, 2008. “Not later than</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:303.50pt;top:4036.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:4086.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:205.25pt;top:4122.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><i><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Contains Nonbinding Recommendations</FONT></FONT></i></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:241.20pt;top:4142.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Draft — Not for Implementation</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:303.50pt;top:4828.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:4159.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">89</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:4173.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">90</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:4187.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">91</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:4201.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">92</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:4215.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">93</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:4228.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">94</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:4242.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">95</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:4256.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">96</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:4270.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">97</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:4283.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">98</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:42.00pt;top:4297.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">99</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:36.00pt;top:4311.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">100</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:36.00pt;top:4325.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">101</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:36.00pt;top:4339.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">102</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:4159.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">60 days after the date of enactment of the Q1 Act” means on or before December 5,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:4173.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">2008.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:135.50pt;top:4171.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:4201.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><i><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Q2:</FONT></FONT></i></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.05pt;top:4201.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><i><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Who must submit the patent information to FDA under section 4(b)(1) of the Q1 Act by</FONT></FONT></i></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:4215.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><b><i><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">December 5, 2008?</FONT></FONT></i></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:4242.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">A2:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:4242.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The sponsor of an NDA approved on or before October 7, 2008, for a drug (including a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:4256.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">combination drug) containing an antibiotic drug that was the subject of an application</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:4270.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">approved under section 507 of the FD&C Act (as in effect before November 21, 1997)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:4283.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">must submit this patent information.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:282.80pt;top:4281.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:4311.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">For information on the submission of patent information, please consult the Agency’s regulations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:4325.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">governing the submission of patent information at 21 CFR 314.50(h) and 314.53.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:72pt;top:4625pt;width:144pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:4629.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.48pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:77.75pt;top:4631.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Section 4(b)(1) of the Q1 Act requires the submission of patent information to FDA “not later than sixty days after</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:4642.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">enactment of [the Q1 Act].” Sixty days after enactment falls on Sunday, December 7, 2008.  Therefore, to be in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:4654.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">compliance with this provision, sponsors must submit the patent information on or before the weekday preceding</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:4665.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">December 7, 2008, that is, on or before December 5, 2008.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:4687.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.48pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:77.75pt;top:4688.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">The application of section 4(b)(1) of the Q1 Act set forth in this guidance gives meaning to both section 505(v) of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:4700.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">the FD&C Act, as added by section 4(a) of the Q1 Act, and the legislation’s transitional rules at section 4(b).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:4711.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Section 4(b)(3) of the Q1 Act contemplates submission of patent certifications by applicants of pending ANDAs that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:4723.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">reference drugs for which patent information must be listed under section 4(b)(1).  By statute, ANDAs may</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:4734.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">reference only already approved drugs.  </FONT></FONT><FONT COLOR="000000"><i><FONT STYLE="font-size: 10.02pt">See </FONT></i><FONT STYLE="font-size: 10.02pt">21 U.S.C. 355(j)(2)(A). Therefore, the drugs referenced by these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:4746.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">pending ANDAs (that is, drugs for which patent information was submitted under section 4(b)(1) of the Q1 Act)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:4757.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">must be drugs that were approved on or before October 7, 2008.  This approach is further supported by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:4769.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">requirement that FDA must, upon receipt of the patent information required to be submitted under 4(b)(1) of the Q1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:4780.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Act, publish the information in the electronic version of FDA’s </FONT></FONT><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Approved Drug Products with Therapeutic</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:4792.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><i><FONT STYLE="font-size: 10.02pt">Equivalents </FONT></i><FONT STYLE="font-size: 10.02pt">(the Orange Book). Per section 505(j)(7) of the FD&C Act, the Orange Book includes only information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.00pt;top:4803.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">about approved drugs.  </FONT></FONT><FONT COLOR="000000"><i><FONT STYLE="font-size: 10.02pt">See </FONT></i><FONT STYLE="font-size: 10.02pt">section (4)(b)(2) of the Q1 Act.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:4878.00pt"> </SPAN>
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