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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 103951Orig1s5173 ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS

APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:

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Page 1: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

103951Orig1s5173

ADMINISTRATIVE and CORRESPONDENCE

DOCUMENTS

Page 2: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 3: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 4: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 5: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 6: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 7: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 8: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 9: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 10: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 11: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 12: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 13: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 14: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 15: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 16: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 17: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 18: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 19: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 20: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 21: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 22: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 23: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 24: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 25: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 26: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 27: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 28: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 29: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 30: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 31: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 32: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 33: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 34: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 35: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 36: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 37: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 38: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 39: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 40: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 41: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 42: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 43: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 44: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 45: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 46: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 47: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 48: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 49: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 50: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 51: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 52: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 53: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 54: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 55: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 56: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 57: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 58: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 59: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 60: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 61: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 62: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 63: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 64: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 65: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 66: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 67: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 68: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 69: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 70: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 71: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 72: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 73: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 74: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 75: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 76: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 77: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
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Page 81: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 82: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 83: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
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Page 85: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
Page 86: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
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Page 88: APPLICATION NUMBER: 103951Orig1s5173€¦ · Karen Karen D. Jones CPMS OODP/DBOP 301-796-1377 From: Williams, Elizabeth Sent: Friday, June 10, 2011 4:27 PM To: Carmouze, Grace Cc:
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