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| Dockets Entered
On January 23, 2006
Table of Contents
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| Docket #
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| Title
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| 1999P-4613
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| Revoke the Regulation That Approved Posilac
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| 2000P-0586
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| Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
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| 2000P-1491
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| Amend Definition & Standard of Identy for Parmesan Cheese
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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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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| 2005D-0362
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| Guidance for Industry on Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies
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| 2005N-0098
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| Food and Drug Administration/Drug Information Association Cross Labeling Workshop: Combination Products and Mutually Conforming Labeling
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| 2005N-0285
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| Current Good Manufacturing Practice Regulation and Investigational New Drugs
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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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| 2005P-0182
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| Withdraw April 14, 2003, Warning Letter, CBER 03-010, addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006E-0046
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| Patent Extension Application for Onyx Liquid Embolic System (LES), U.S. Patent No. 5,667,767
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| 1999P-4613
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| Revoke the Regulation That Approved Posilac
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| EMC 2431
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| J. Kramer
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| Vol #:
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| 46
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| 2000P-0586
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| Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
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| EMC
16
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| National Farmers Union
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| Vol #:
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| 28
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| EMC
17
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| Dairy Australian
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| Vol #:
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| 28
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| 2000P-1491
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| Amend Definition & Standard of Identy for Parmesan Cheese
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| C
8
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| O-AT-KA Milk Products Cooperative, Inc. (O-AT-KA)
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| Vol #:
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| 1
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| C
529
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| Farm Sanctuary
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| Vol #:
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| 45
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 590
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| Mission Possible International
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| Vol #:
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| 9
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 1196
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| No signature
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| Vol #:
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| 12
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| EMC 1197
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| C. Suhre
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| Vol #:
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| 12
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| EMC 1198
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| No signature
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| Vol #:
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| 12
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| EMC 1199
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| Daniel G.
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| Vol #:
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| 12
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| EMC 1200
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| C. Brooke
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| Vol #:
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| 12
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| EMC 1201
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| No signature
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| Vol #:
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| 12
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| EMC 1202
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| A. Mammini
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| Vol #:
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| 12
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| EMC 1203
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| No signature
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| Vol #:
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| 12
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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| EXT 1
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| B. Sachau
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| Vol #:
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| 2
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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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| EMC
5
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| Community Blood Center of the Ozarks
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| Vol #:
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| 6
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| 2005D-0362
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| Guidance for Industry on Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies
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| EMC
1
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| Plasma Protein Therapeutics Association (PPTA)
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| Vol #:
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| 1
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| 2005N-0098
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| Food and Drug Administration/Drug Information Association Cross Labeling Workshop: Combination Products and Mutually Conforming Labeling
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| EMC
2
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| Combination Product Coalition
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| Vol #:
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| 1
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| 2005N-0285
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| Current Good Manufacturing Practice Regulation and Investigational New Drugs
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| EMC 1
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| B. Sachau
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| Vol #:
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| 1
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| EMC 2
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| B. Sachau
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| Vol #:
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| 1
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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 496
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| K. Maxwell
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| Vol #:
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| 165
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| 2005P-0182
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| Withdraw April 14, 2003, Warning Letter, CBER 03-010, addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA
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| LET
2
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| Simpson Woolley McConacnie, LLP
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| Vol #:
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| 2
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| C 342
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| B. Goutal
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| Vol #:
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| 5
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| C 343
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| B. Parrot
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| Vol #:
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| 5
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| C 344
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| J. Parrot
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| Vol #:
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| 5
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| C 345
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| K. Hall
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| Vol #:
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| 5
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| C 346
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| L. Birdwell
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| Vol #:
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| 5
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| C 347
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| S. Bell
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| Vol #:
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| 5
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| C 348
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| M. Long
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| Vol #:
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| 3
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| C 349
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| M. Holley
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| Vol #:
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| 5
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| C 350
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| M. Long
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| Vol #:
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| 5
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| C 351
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| J. Tommgas
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| Vol #:
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| 5
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| C 352
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| M. Hartley
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| Vol #:
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| 5
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| C 353
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| T. Stafford
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| Vol #:
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| 5
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| C 354
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| P. Kimball
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| Vol #:
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| 5
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