2006N-0062:
Expanded Access to Investigational Drugs for Treatment Use
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| Document #
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| Received Date
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| Filed
Date
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| Submitter Code
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| Submitter
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| FR
Date
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| FR
Page
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| Comment Date
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| Files
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| Remarks
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| REF1
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| 12/12/2006
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| 12/12/2006
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| Federal Government
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| HF-26
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| pdf
Attachment
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| OMB review for December
14, 2006.
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| Signature:
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| Diane Sullivan, B.S., J.D.
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| NPR1
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| 12/11/2006
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| FDA
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| FDA
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| 12/14/2006
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| 75147-75168
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| 03/14/2007
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| txt
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| Signature:
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| JEFFREY SHUREN
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| EC1
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| 12/18/2006
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| 12/16/2006
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| Individual Consumer
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| Mr. Lawrence Silberman
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| EC2
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| 12/18/2006
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| 12/16/2006
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| Individual Consumer
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| Ms. Laureen Wallace
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| C1
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| 12/18/2006
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| 12/13/2006
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| Health Professional
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| S. Fink, MD
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| EREG1
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| 12/18/2006
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| 12/17/2006
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| Individual Consumer
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| D. Kaylor
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| txt
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| EC3
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| 12/21/2006
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| 12/20/2006
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| Health Professional
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| Dr. Sidney Fink
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| EC4
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| 12/22/2006
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| 12/21/2006
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| Drug Industry
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| Mrs. ann brenner
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| EC5
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| 12/26/2006
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| 12/22/2006
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| Health Professional
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| SUNY at Stony Brook
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| htm
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| Signature:
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| Fink, Max
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| EC6
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| 12/27/2006
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| 12/26/2006
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| Health Care Association
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| Geisinger Health Plan
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| pdf
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| Signature:
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| Yarczower, Bret
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| EC7
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| 12/29/2006
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| 12/28/2006
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| Individual Consumer
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| none
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| Signature:
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| Varadi, Jeff
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| EC8
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| 01/04/2007
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| 01/03/2007
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| Individual Consumer
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| Ms. Zoe Kyriacos
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| EC9
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| 01/05/2007
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| 01/04/2007
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| Individual Consumer
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| Mr. B Fields
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| C2
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| 12/29/2006
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| 12/27/2006
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| Consumer Group
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| Crohn's & Colitis
Foundation of America (CCFA) and Advocacy for Patients with
Chronic Illness, Inc.
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| pdf
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| Signature:
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| Richard J. Geswell and Jennifer
C. Ja
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| EC10
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| 01/08/2007
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| 01/06/2007
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| Individual Consumer
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| self
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| Signature:
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| Mueller, Joan
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| C3
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| 01/12/2007
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| 01/12/2007
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| Health Care Association
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| UnitedHealthcare Group
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| pdf
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| Signature:
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| Richard A. Justman, MD
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| EC11
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| 01/19/2007
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| 01/16/2007
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| Health Care Association
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| National Organization
for Rare Disorders (NORD)
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| pdf
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| Signature:
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| Meyers, Abbey
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| EC12
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| 01/19/2007
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| 01/17/2007
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| Local Government
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| Ms. Redrina Rios
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| C4
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| 01/19/2007
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| 01/19/2007
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| Association
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| National Organization
for Rare Disorders, Inc. (NORD)
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| pdf
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| Signature:
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| Abbey S. Meyers
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| EC13
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| 01/26/2007
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| 01/22/2007
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| Individual Consumer
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| Mr. William Seldeen
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| EC14
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| 01/26/2007
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| 01/24/2007
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| Health Professional
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| Mr. William Katakis
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| C5
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| 01/31/2007
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| 01/30/2007
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| Drug Industry
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| Vital Therapies
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| pdf
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| Signature:
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| Terry Winters, PhD and Kameron
Max
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| C6
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| 02/28/2007
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| 02/23/2007
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| Individual
Consumer
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| J. Benham
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| C7
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| 03/05/2007
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| 03/05/2007
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| Individual
Consumer
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| D Swanson RPh
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| C8
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| 03/08/2007
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| 03/05/2007
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| Consumer Group
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| Breast Cancer
Action
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| pdf
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| Signature:
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| Barbara A Brenner, Jane
Zones
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| EXT1
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| 03/08/2007
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| 03/08/2007
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| Consumer Group
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| Public Citizen
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| pdf
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| Signature:
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| Peter Lurie MD MPH
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| EC15
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| 03/13/2007
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| 02/13/2007
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| Consumer Group
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| The Life Raft
Group
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| pdf
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| Signature:
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| Call, Jerry
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| EC16
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| 03/13/2007
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| 02/15/2007
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| Consumer Group
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| The Annie Appleseed
Project
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| pdf
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| Signature:
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| Fonfa, Ann
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| EC17
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| 03/13/2007
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| 02/18/2007
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| Consumer Group
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| The Alliance
Against Exceptionally Rare Diseases
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| pdf
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| Signature:
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| Thornton, Mark
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| EC18
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| 03/13/2007
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| 02/26/2007
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| Individual
Consumer
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| Mr. Raymond
Campbell
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| EC19
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| 03/13/2007
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| 02/27/2007
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| Consumer Group
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| Patients Against
Lymphoma
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| No attachment
received
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| Signature:
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| Schwartz, Karl
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| EC20
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| 03/13/2007
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| 02/27/2007
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| Individual
Consumer
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| Mrs. nancy
ledonne
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| EC21
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| 03/13/2007
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| 03/02/2007
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| Individual
Consumer
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| Family of
Patient
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| EC22
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| 03/13/2007
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| 03/02/2007
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| Individual
Consumer
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| Mr. Donald
Kenney
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| EC23
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| 03/13/2007
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| 03/02/2007
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| Individual
Consumer
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| Mrs. Nita
Bradford
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| EC24
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| 03/13/2007
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| 03/02/2007
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| Federal
Government
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| Mr. John Doran
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| Signature:
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| Doran, John
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| EC25
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| 03/13/2007
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| 03/04/2007
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| Individual
Consumer
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| Mr. William D. Doran,
Colonel, USAF
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| EC26
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| 03/13/2007
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| 03/05/2007
|
| Health
Professional
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| Dr. margaret
hagan
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| Signature:
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| hagan, margaret
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| EC27
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| 03/13/2007
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| 03/05/2007
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| Consumer Group
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| Huntington's Disease
Drug Works.
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| htm
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| Signature:
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| Veatch Goodman, LaVonne
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| EC28
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| 03/13/2007
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| 03/07/2007
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| Association
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| National Association
of Epilepsy Centers (NAEC)
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| htm
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| Signature:
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| Gumnit, Robert
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| EC29
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| 03/13/2007
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| 03/09/2007
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| Other
Organization
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| America's Health
Insurance Plans
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| htm
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| Signature:
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| Ignagni, Karen
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| EC30
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| 03/13/2007
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| 03/09/2007
|
| Individual
Consumer
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| Ms. Judy Werth
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| EC31
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| 03/13/2007
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| 03/09/2007
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| Individual
Consumer
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| Ms. Judy Werth
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| EC32
|
| 03/13/2007
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| 03/11/2007
|
| Individual
Consumer
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| Mr. Jeff
Bennett
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| EC33
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| 03/13/2007
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| 03/11/2007
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| Consumer Group
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| Marti Nelson Cancer
Foundation
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| htm
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| Signature:
|
| Erwin, Robert
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| EC34
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| 03/13/2007
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| 03/11/2007
|
| Individual
Consumer
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| Mr. Walter C.
Sterling,Jr.
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| EC35
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| 03/13/2007
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| 03/12/2007
|
| Other
Government
|
| Mr. Gregory
Brown
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| htm
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| Signature:
|
| Brown, Gregory
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| EC36
|
| 03/13/2007
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| 03/12/2007
|
| Individual
Consumer
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| Ms. Scott
Graffius
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| EC37
|
| 03/13/2007
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| 03/12/2007
|
| Individual
Consumer
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| Ms. Carolyn
Williams
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| EC38
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| 03/13/2007
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| 03/12/2007
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| Individual
Consumer
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| Mr. d.
greenberg
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| EC39
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| 03/13/2007
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| 03/12/2007
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| Individual
Consumer
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| Mrs. carla
Gamradt
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| EC40
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| 03/13/2007
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| 03/12/2007
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| Drug Industry
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| Mrs. Gail
Larsen
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| EC41
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| 03/13/2007
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| 03/12/2007
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| Individual
Consumer
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| Mr. John
Strongitharm
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| EC42
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| 03/13/2007
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| 03/12/2007
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| Individual
Consumer
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| Mr. Mitch
Peterson
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| EC43
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| 03/13/2007
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| 03/12/2007
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| Local
Government
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| Mrs. Barbara
Everhart
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| EC44
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| 03/13/2007
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| 03/12/2007
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| Individual
Consumer
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| Mr. Robert
Everhart
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| EC45
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| 03/13/2007
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| 03/12/2007
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| Individual
Consumer
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| Mr. Erik
Roadfeldt
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| EC46
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| 03/13/2007
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| 03/12/2007
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| Individual
Consumer
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| Ms. Jennifer
Lynch
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| EC47
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| 03/13/2007
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| 03/12/2007
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| Drug Industry
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| Novo Nordisk
Inc.
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| htm
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| Signature:
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| McElligott, Mary Ann
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| EC48
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| 03/13/2007
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| 03/12/2007
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| Health Care
Association
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| Hemophilia Association
of the Capital Area
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| pdf
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| Signature:
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| Qualley, Sandi
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| EC49
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| 03/13/2007
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| 03/12/2007
|
| International Organization
|
| Forum for
Collaborative HIV Research
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| htm
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| Signature:
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| Cheng, Ben
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| EC50
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| 03/13/2007
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| 03/12/2007
|
| Individual
Consumer
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| Ms. Donna Spear
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| EC51
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| 03/13/2007
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| 03/12/2007
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| Individual
Consumer
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| Mr. Tomas Owen
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| EC52
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| 03/13/2007
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| 03/12/2007
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| Individual
Consumer
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| Mr. Charles
LaFleur
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| EC53
|
| 03/13/2007
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| 03/12/2007
|
| Drug Industry
|
| Eli Lilly
|
|
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| htm
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|
| Signature:
|
| Mockbee, Colleen
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|
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| EC54
|
| 03/13/2007
|
| 03/12/2007
|
| Individual
Consumer
|
| Ms. Beverly
Hill
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| EC55
|
| 03/13/2007
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| 03/12/2007
|
| Individual
Consumer
|
| Mr. bob mills
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| EC56
|
| 03/13/2007
|
| 03/12/2007
|
| Individual
Consumer
|
| Mrs. Kathy
Mills
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| EC57
|
| 03/13/2007
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| 03/12/2007
|
| Consumer Group
|
| Ovarian Cancer
National Alliance
|
|
|
|
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|
|
| htm
|
|
|
|
| Signature:
|
| Salway Black, Sherry
|
|
| EC58
|
| 03/13/2007
|
| 03/12/2007
|
| Individual
Consumer
|
| Mr. Dylan Mills
|
|
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| EC59
|
| 03/13/2007
|
| 03/13/2007
|
| Individual
Consumer
|
| Mr. Jarry
Keppers
|
|
|
|
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|
|
|
|
| EXT2
|
| 03/12/2007
|
| 03/12/2007
|
| Private
Industry
|
| Pendergast
Consulting
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Mary K Pendergast JD LLM
|
|
|
| C9
|
| 03/12/2007
|
| 03/12/2007
|
| Individual
Consumer
|
| O Kistler
|
|
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|
| C10
|
| 03/12/2007
|
| 03/12/2007
|
| Private
Industry
|
| Applied Cutting
Technology Inc
|
|
|
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|
|
| pdf
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|
|
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| Signature:
|
| Olivia P Kistler
|
|
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| M1
|
| 03/12/2007
|
| 03/12/2007
|
| Federal
Government
|
| FDA
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Jeffrey Shuren
|
|
| |
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| Up | Most Recent
Page last updated:
July 10, 2007
|