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| Dockets Entered
On October 5, 2005
Table of Contents
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| Docket #
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| Title
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| 1976N-0052G
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| OTC general comments & combinations
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| |
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| 1977N-0094
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| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
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| |
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| 2001D-0044
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| Clinical Laboratory Improvement Amendments of 1988
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| 2001D-0584
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| Reduce the Risk of Transmission of HIV-1 & HCV
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| |
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| 2005D-0288
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| International Conference on Harmonisation; Draft Guidance on Q9 Quality Risk Management
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| |
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| 2005D-0330
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| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
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| |
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| 2005D-0390
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| International Conference on Harmonisation; Guidance on E2B(R) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
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| |
|
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| 2005N-0218
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| FDA Vision 2006: A Conversation with the American Public
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| |
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| |
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| 2005P-0376
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| Iceberg Water Deviating From Identity Standard; Temporary Permit for Market Testing
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| 1976N-0052G
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| OTC general comments & combinations
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| EXT
3
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| D & E Pharmaceuticals, Inc.
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| Vol #:
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| 35
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| |
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| MT
4
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| Between FDA and Barnes & Thornburg LLP
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| Vol #:
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| 35
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| 1977N-0094
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| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
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| SUP
57
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| University of Alabama at Birmingham (UAB)
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| Vol #:
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| 257
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| 2001D-0044
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| Clinical Laboratory Improvement Amendments of 1988
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| EC
2
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| DPHHS, QA Division, CLIA
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| Vol #:
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| 3
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| 2001D-0584
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| Reduce the Risk of Transmission of HIV-1 & HCV
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| EC 3
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| Mr. Daniel Garrett
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| Vol #:
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| 1
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| |
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| NFR
2
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| FDA
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| Vol #:
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| 28
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| C
150
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| The Dow Chemical Company (Dow)
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| Vol #:
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| 13
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| 2005D-0288
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| International Conference on Harmonisation; Draft Guidance on Q9 Quality Risk Management
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| C
4
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| Japan Society of Pharmaceutical Machinery and Engineering (JSPME)
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| Vol #:
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| 1
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| |
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| 2005D-0330
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| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
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| NAD
1
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| FDA
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| Vol #:
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| 3
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|
| | | | | | | | |
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| 2005D-0390
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| International Conference on Harmonisation; Guidance on E2B(R) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
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| GDL
1
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| Guidance
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| Vol #:
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| 1
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| |
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| NAD
1
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| FDA
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| Vol #:
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| 1
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|
| |
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| 2005N-0218
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| FDA Vision 2006: A Conversation with the American Public
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| |
|
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| N
2
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| FDA
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| Vol #:
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| 1
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| |
|
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| C 49
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| S. Sepulvedo
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| Vol #:
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| 9
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| C 50
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| S. Leacte
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| Vol #:
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| 9
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| C 51
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| B. Brown
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| Vol #:
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| 9
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| EC
556
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| Another Way Pregnancy Center
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| Vol #:
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| 6
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| EC 557
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| Dr. Sara Hanson
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| Vol #:
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| 6
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| EC
558
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| Univ of Ala Birmingham
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| Vol #:
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| 6
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| EC 559
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| Ms. Loretta Fleming
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| Vol #:
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| 6
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| EC 560
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| Miss. Christal Boyd
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| Vol #:
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| 6
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| EC 561
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| Mrs. Debra Kaye
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| Vol #:
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| 6
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| |
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| LET
1
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| HFD-240 to W. David Hager, M.D.
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| Vol #:
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| 9
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| |
|
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| EAPE 1
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| Mayhew, Brian
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| Vol #:
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| 1
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| EAPE 2
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| Mallikaarjun, Kusuma
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| Vol #:
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| 1
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| EAPE 3
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| Chiu, Yuan-yuan
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| Vol #:
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| 1
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| EAPE 4
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| Conner, Brian
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| Vol #:
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| 1
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| EAPE 5
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| Barak, Sarah
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| Vol #:
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| 1
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| EAPE 6
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| Hetrick, Lauren
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| Vol #:
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| 1
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| EAPE 7
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| Henderson, Diedtra
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| Vol #:
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| 1
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| EAPE 8
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| Aleknavage, Debra
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| Vol #:
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| 1
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| EAPE 9
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| Phillips, Sharon
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| Vol #:
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| 1
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| EAPE 10
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| Mitrione, Diane
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| Vol #:
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| 1
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| EAPE 11
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| Jones, Carolyn
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| Vol #:
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| 1
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| EAPE 12
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| Kamp, John
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| Vol #:
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| 1
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| EAPE 13
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| Hirano, Patricia
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| Vol #:
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| 1
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| EAPE 14
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| Schoonmaker, Michele
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| Vol #:
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| 1
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| EAPE 15
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| Krapf, David
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| Vol #:
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| 1
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| EAPE 16
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| Johnson, Mary
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| Vol #:
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| 1
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| EAPE 17
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| Jarrell, Dayle
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| Vol #:
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| 1
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| EAPE 18
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| Finley, Marilyn
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| Vol #:
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| 1
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| EAPE 19
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| Tracy, Julie
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| Vol #:
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| 1
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| EAPE 20
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| Domecus, Cindy
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| Vol #:
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| 1
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| |
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| EAPE 21
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| Riley, Karen
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| Vol #:
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| 1
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| EAPE 22
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| Pitts, Peter
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| Vol #:
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| 1
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| EAPE 23
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| Peterson, Jayne
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| Vol #:
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| 1
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| EAPE 24
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| Jenkins-Showalter, Janet
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| Vol #:
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| 1
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| EAPE 25
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| Chalkley, Walter
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| Vol #:
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| 1
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| EAPE 26
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| Vaughan, William
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| Vol #:
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| 1
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| EAPE 27
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| Salditt, Diana
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| Vol #:
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| 1
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| EAPE 28
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| Henry, Ann Karen
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| Vol #:
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| 1
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| EAPE 29
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| Manicka, Ed
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| Vol #:
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| 1
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| EAPE 30
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| Bhat, Madhuri
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| Vol #:
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| 1
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| EAPE 31
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| Antons, Ilze
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| Vol #:
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| 1
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| EAPE 32
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| Bishop, Susan
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| Vol #:
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| 1
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| EAPE 33
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| Kothe, Angela
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| Vol #:
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| 1
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| EAPE 34
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| LeBrun, Vera
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| Vol #:
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| 1
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| EAPE 35
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| Grossman, Amy
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| Vol #:
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| 1
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| EAPE 36
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| Purser, Asuncion
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| Vol #:
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| 1
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| EAPE 37
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| Pinto, Preeti
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| Vol #:
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| 1
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| EAPE 38
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| Murphy, Juli
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| Vol #:
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| 1
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| EAPE 39
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| Apruzzese, Don
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| Vol #:
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| 1
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| EAPE 40
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| Falcetti, Catherine
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| Vol #:
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| 1
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| EAPE 41
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| Monford , Jeff
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| Vol #:
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| 1
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| EAPE 42
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| Baker, Pam
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| Vol #:
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| 1
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| EAPE 43
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| Hirsch, Lyndi
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| Vol #:
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| 1
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| EAPE 44
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| Hotvedt, Edgar
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| Vol #:
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| 1
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| |
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| EAPE 45
|
| Savidge, Paul
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| Vol #:
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| 1
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| |
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| EAPE 46
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| Anduze-Faris, Beatrice
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| Vol #:
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| 1
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| |
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| EAPE 47
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| Frosst, Phyllis
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| Vol #:
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| 1
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| |
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| EAPE 48
|
| Scholes, Derek
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| Vol #:
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| 1
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| |
|
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| EAPE 49
|
| Boyle, Paul
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| Vol #:
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| 1
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| |
|
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| EAPE 50
|
| Hodo, Lori
|
| Vol #:
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| 1
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| |
|
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| EAPE 51
|
| Tyler, Eliot
|
| Vol #:
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| 1
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| |
|
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| EAPE 52
|
| Kennedy, Jeanie
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| Vol #:
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| 1
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| |
|
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| EAPE 53
|
| Davidson, James
|
| Vol #:
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| 1
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| |
|
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| EAPE 54
|
| North, Nan
|
| Vol #:
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| 1
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| |
|
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| EAPE 55
|
| Reinhart, Rosann
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| Vol #:
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| 1
|
|
| | | | | | | |
| |
|
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| EAPE 56
|
| Kalter, Sandra
|
| Vol #:
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| 1
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| |
|
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| EAPE 57
|
| Cavallini, Mario
|
| Vol #:
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| 1
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| |
|
|
| EAPE 58
|
| Konnerth, Nancy
|
| Vol #:
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| 1
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| |
|
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| EAPE 59
|
| Pollitz, Linda
|
| Vol #:
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| 1
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| |
|
|
| EAPE 60
|
| Pavillard, Jennifer
|
| Vol #:
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| 1
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| |
|
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| EAPE 61
|
| Plon, Judith
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| Vol #:
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| 1
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| |
|
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| EAPE 62
|
| Jones, Christine-Elaine
|
| Vol #:
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| 1
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| |
|
|
| EAPE 63
|
| Rotman, Harris
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| Vol #:
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| 1
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| |
|
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| EAPE 64
|
| Rockney, Tracy
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| Vol #:
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| 1
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| |
|
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| EAPE 65
|
| cranston, joseph
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| Vol #:
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| 1
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| |
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| EAPE 66
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| Perlman, Jeffry
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| Vol #:
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| 1
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| |
|
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| EAPE 67
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| Rector, Clark
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| Vol #:
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| 1
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| |
|
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| EAPE 68
|
| Kohlmeyer, Robert
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| Vol #:
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| 1
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| |
|
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| EAPE 69
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| Closurdo, Frank
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| Vol #:
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| 1
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| |
|
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| EAPE 70
|
| Tandy, Marlene
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| Vol #:
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| 1
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| |
|
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| EAPE 71
|
| Benesch, Bryan
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| Vol #:
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| 1
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| |
|
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| EAPE 72
|
| ehrlich, robert
|
| Vol #:
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| 1
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| |
|
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| EAPE 73
|
| Carrado, Joseph
|
| Vol #:
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| 1
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| |
|
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| EAPE 74
|
| Briddell, Adam
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| Vol #:
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| 1
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| |
|
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| EAPE 75
|
| Stearns, Frederick
|
| Vol #:
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| 1
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| |
|
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| EAPE 76
|
| Person, William
|
| Vol #:
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| 1
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| |
|
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| EAPE 77
|
| Rose, Janet
|
| Vol #:
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| 1
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| |
|
|
| EAPE 78
|
| morris, louis
|
| Vol #:
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| 1
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| |
|
|
| EAPE 79
|
| norby, deborah
|
| Vol #:
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| 1
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| |
|
|
| EAPE 80
|
| Gallagher, Maryann
|
| Vol #:
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| 1
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| |
|
|
| EAPE 81
|
| Bahnatka, Ed
|
| Vol #:
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| 1
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| |
|
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| EAPE 82
|
| Evans, Christine
|
| Vol #:
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| 1
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| |
|
|
| EAPE 83
|
| Yun, Judy
|
| Vol #:
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| 1
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| |
|
|
| EAPE 84
|
| Ben-Maimon, Carole
|
| Vol #:
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| 1
|
| |
|
|
| EAPE 85
|
| Restum, Janelle
|
| Vol #:
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| 1
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| |
|
|
| EAPE 86
|
| Norden, Janet
|
| Vol #:
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| 1
|
| |
|
|
| EAPE 87
|
| Niemann, Amy
|
| Vol #:
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| 1
|
| |
|
|
| EAPE 88
|
| Baranello, Roy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 89
|
| Mack, John
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 90
|
| Calfee, John E.
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 91
|
| Snyder, Wallace
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 92
|
| Snyder, Wallace
|
| Vol #:
|
| 1
|
|
| | | | | | | |
| |
|
|
| EAPE 93
|
| Pines, Wayne
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 94
|
| Rogin, Carole
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 95
|
| Pines, Wayne
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 96
|
| Cooper, Jordan
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 97
|
| Pines, Wayne
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 98
|
| Ronald, Lorna
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 99
|
| Simons, Dee
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 100
|
| Scanlon, Rose Ann
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 101
|
| Eccles, Cheryl-Ann
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 102
|
| Webb, Janet
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 103
|
| Lucey, Anne
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 104
|
| MacKinnon, Gail
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 105
|
| Horrigan, David
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 106
|
| Cohen, Rita
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 107
|
| Cregan, James
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 108
|
| Newman, David
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 109
|
| Glinert, Lewis
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 110
|
| Wu, Winifred
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 111
|
| Dhillon, Harinder
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 112
|
| Bump, Christine
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 113
|
| Henteleff, Tom
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 114
|
| Warth, Karen
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 115
|
| Matsuzaki, Tomoko
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 116
|
| Glaser, Ginger
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 117
|
| Abel, Gregory
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 118
|
| Hansel, Leighton
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 119
|
| Walker, Melissa
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 120
|
| Cunningham, Rose
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 121
|
| PATEL, SUBHASH
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 122
|
| Wolf, Deborah
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 123
|
| Ulatowski, Timothy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 124
|
| Tolbert, Margaret
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 125
|
| Thomas, Al
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 126
|
| Silberberg, Paula
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 127
|
| Clark, Robert
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 128
|
| Dick-Rath, Deborah
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 129
|
| Molnar-Hammond, Marie
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| EAPE 130
|
| Molnar-Hammond, Marie
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 131
|
| Reynolds, Robert
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 132
|
| Dvorak, Cecily
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 133
|
| Marotta, Robert
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 134
|
| Thomaselli, Rich
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 135
|
| Shetsky, Marsha
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 136
|
| Cahill, Judith
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 137
|
| Schlaifer, Marissa
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 138
|
| Finch, Christopher
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 139
|
| Federici, Dayna
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 140
|
| Schirmer, Andrew
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 141
|
| Chu, Gary
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 142
|
| Hunter, Simon
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 143
|
| Minchella-Griebsch, Nadia
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 144
|
| Bradford, David
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 145
|
| Vaughan, William
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 146
|
| Kendall, Poppy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 147
|
| Liversidge, Ellen
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 148
|
| Mintzes, Barbara
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 149
|
| Tosh, Mark
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 150
|
| Pohmajevich, Lisa
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 151
|
| Mettler, Erik
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 152
|
| Pepe, Donna
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 153
|
| Braman, Amie
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 154
|
| Teinowitz, Ira
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 155
|
| Grillo, Joseph
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 156
|
| Moncavage, Melissa
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 157
|
| Safarik, Michelle
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0394
|
| FDAs Communication of Drug Safety Information; Public Hearing
|
| |
|
|
| EAPE 1
|
| Mettler, Erik
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 2
|
| Morris, Louis
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0376
|
| Iceberg Water Deviating From Identity Standard; Temporary Permit for Market Testing
|
| |
|
|
| NTP
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
