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| Dockets Entered
On January 25, 2007
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| Docket #
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| Title
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| 1999E-0116
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| Patent Extension Rotashield, #4,704,275
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| 2005E-0236
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| Patent Extension Application for MULTIHANCE (gadobenate dimeglumine), U.S. Patent No. 4,916,246
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| 2005E-0245
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| Patent Extension Application for KEPIVANCE (palifermin), U.S. Patent No. 5,677,278
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| 2005E-0259
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| Patent Extension Application for EMTRIVA (emtricitabine), U.S. Patent No. 5,914,331
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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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-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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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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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| 2006D-0463
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| Guidance for Industry on Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment; Availability
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| 2006E-0034
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| Patent Extension Application for PREVICOX (firocoxib), U. S. Patent No. 5,981,576
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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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| 2006E-0240
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| Patent Extension Application for REVLIMID (lenalidomide), U.S. Patent No. 5,635,517
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| 2006E-0478
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| Patent Extension Application for NovoLog insulin aspart (rDNA origin) injection, U.S. Patent No. 5,618,913
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| 2006N-0036
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur
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| 2006N-0416
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| Use of Ozone-Depleting Substances; Removal of Essential Use Designations
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| 1999E-0116
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| Patent Extension Rotashield, #4,704,275
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| LET 3
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 756
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| L. Abbey
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| Vol #:
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| 10
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| EMC 85
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| H. Delaney
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| Vol #:
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| 5
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| EMC 86
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| X. Legault
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| Vol #:
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| 5
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| EMC 87
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| J. Gerdes
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| Vol #:
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| 5
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| EMC 88
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| G. Higby
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| Vol #:
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| 5
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| EMC 89
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| E. Tetens
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| Vol #:
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| 5
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| EMC 90
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| B. Romero
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| Vol #:
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| 5
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| EMC 91
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| B. Joosse
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| Vol #:
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| 5
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| EMC 92
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| D. Mather
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| Vol #:
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| 5
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|
| | | | | | | | |
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| EMC 93
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| B. Lindtner
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| Vol #:
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| 5
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|
|
| EMC 94
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| B. Foose
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| Vol #:
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| 5
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|
|
| EMC 95
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| R. Bratman
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| Vol #:
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| 5
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|
|
| EMC 96
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| W. Phillips
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| Vol #:
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| 5
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|
| EMC 97
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| R. Vosburg
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| Vol #:
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| 5
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|
|
| EMC 98
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| P. Blochowiak
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| Vol #:
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| 5
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|
|
| EMC 99
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| T. Fisk
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| Vol #:
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| 5
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|
|
| EMC 100
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| A. Laguna
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| Vol #:
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| 5
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|
|
| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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|
|
|
|
|
|
| EMC 794
|
| G. Ocasio
|
| Vol #:
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| 9
|
|
|
| 2005E-0236
|
| Patent Extension Application for MULTIHANCE (gadobenate dimeglumine), U.S. Patent No. 4,916,246
|
|
|
| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2005E-0245
|
| Patent Extension Application for KEPIVANCE (palifermin), U.S. Patent No. 5,677,278
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|
|
| LET 3
|
| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
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| Vol #:
|
| 1
|
|
|
| 2005E-0259
|
| Patent Extension Application for EMTRIVA (emtricitabine), U.S. Patent No. 5,914,331
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|
|
| LET 4
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| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
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| Vol #:
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| 1
|
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
|
|
| BKG 2
|
| Background Material
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| Vol #:
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| 24
|
|
|
| EMC 306
|
| S. Wickersham
|
| Vol #:
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| 23
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|
|
| EREG 1
|
| Celiac Support Group of Vermont
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| Vol #:
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| 23
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|
|
| EREG 2
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| J. Greer-Carney
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| Vol #:
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| 23
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|
|
| EREG 3
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| School Sisters of Notre Dame/Celiac Sprue Association
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| Vol #:
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| 23
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|
|
| EREG 4
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| A. Tyler
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| Vol #:
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| 23
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|
|
| EREG 5
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| J. Akre
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| Vol #:
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| 23
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|
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| EREG 6
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| Hampton & Associates
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| Vol #:
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| 23
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|
|
| EREG 7
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| V. Lee
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| Vol #:
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| 23
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|
|
| EREG 8
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| M. Adams
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| Vol #:
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| 23
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|
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| EREG 9
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| K. Scott
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| Vol #:
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| 23
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|
|
| EREG 10
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| Celiac Support Group
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| Vol #:
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| 23
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|
|
| EREG 11
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| R. Germain
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| Vol #:
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| 23
|
|
|
| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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|
|
| EMC 591
|
| C. Brownell
|
| Vol #:
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| 12
|
|
| | | | | | | | |
|
|
| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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|
|
|
|
|
|
| EMC 5
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| B. M. T. Processing Laboratories
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| Vol #:
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| 6
|
|
|
| EREG 2
|
| National Council for Prescription Drug Programs
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| Vol #:
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| 3
|
|
|
| EREG 3
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| Academy of Managed Care Pharmacy
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| Vol #:
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| 3
|
|
|
| EREG 4
|
| American Association of Exporters & Importers
|
| Vol #:
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| 3
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
| EMC 4196
|
| M. Abshier
|
| Vol #:
|
| 199
|
|
|
| EMC 4197
|
| M. Driscoll
|
| Vol #:
|
| 199
|
|
|
| EMC 4198
|
| J. Bouldin
|
| Vol #:
|
| 199
|
|
|
| EMC 4199
|
| R. Disselkoen
|
| Vol #:
|
| 199
|
|
|
| EMC 4200
|
| C. McRae
|
| Vol #:
|
| 199
|
|
|
| EMC 4201
|
| N. Morris-Farber
|
| Vol #:
|
| 199
|
|
|
| EMC 4202
|
| D. Schwalb
|
| Vol #:
|
| 199
|
|
|
| EMC 4203
|
| A. Lobdell
|
| Vol #:
|
| 199
|
|
|
| EMC 4204
|
| N. Gee
|
| Vol #:
|
| 199
|
|
|
| EMC 4205
|
| J. Johnson
|
| Vol #:
|
| 199
|
|
|
| EMC 4206
|
| P. Troia
|
| Vol #:
|
| 199
|
|
|
| EMC 4207
|
| M. Medlen
|
| Vol #:
|
| 199
|
|
|
| EMC 4208
|
| D. Bellerue
|
| Vol #:
|
| 199
|
|
|
| EMC 4209
|
| D. Kemmerle
|
| Vol #:
|
| 199
|
|
|
| EMC 4210
|
| J. Kenyon
|
| Vol #:
|
| 199
|
|
|
| EMC 4211
|
| P. Wingate
|
| Vol #:
|
| 199
|
|
|
| 2006D-0383
|
| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
|
|
|
|
|
|
|
| C 1387
|
| T. Robinson
|
| Vol #:
|
| 44
|
|
|
| C 1388
|
| Illigible
|
| Vol #:
|
| 44
|
|
|
| C 1389
|
| Illigible
|
| Vol #:
|
| 44
|
|
|
| C 1390
|
| Illigible
|
| Vol #:
|
| 44
|
|
|
| C 1391
|
| A. Nichols
|
| Vol #:
|
| 44
|
|
|
| C 1392
|
| O. Lopez
|
| Vol #:
|
| 44
|
|
|
| C 1393
|
| J. Nemec
|
| Vol #:
|
| 44
|
|
|
| C 1394
|
| M. Kharouf
|
| Vol #:
|
| 44
|
|
|
| C 1395
|
| F. Hansmary
|
| Vol #:
|
| 44
|
|
|
| C 1396
|
| Dr and Mrs A. Pomitto, III
|
| Vol #:
|
| 44
|
|
|
| C 1397
|
| J. Cherplei
|
| Vol #:
|
| 44
|
|
| | | | | | | |
|
|
| C 1398
|
| M. Brewton
|
| Vol #:
|
| 44
|
|
|
| C 1399
|
| M. Ryan
|
| Vol #:
|
| 44
|
|
|
| C 1400
|
| J. Kirchner
|
| Vol #:
|
| 44
|
|
|
| C 1401
|
| M. Kirchner
|
| Vol #:
|
| 44
|
|
|
| C 1402
|
| S. Bailey
|
| Vol #:
|
| 44
|
|
|
| C 1403
|
| L. Murphy
|
| Vol #:
|
| 44
|
|
|
| C 1404
|
| L. Wright
|
| Vol #:
|
| 44
|
|
|
| C 1405
|
| E and J O'Donnell
|
| Vol #:
|
| 44
|
|
|
| C 1406
|
| E. Voss
|
| Vol #:
|
| 44
|
|
|
| C 1407
|
| A. Voss
|
| Vol #:
|
| 44
|
|
|
| C 1408
|
| M. Polizzi
|
| Vol #:
|
| 44
|
|
|
| C 1409
|
| M. Kling
|
| Vol #:
|
| 44
|
|
|
| C 1410
|
| R and R Dufour
|
| Vol #:
|
| 44
|
|
|
| C 1411
|
| Illigible
|
| Vol #:
|
| 44
|
|
|
| C 1412
|
| Illigible
|
| Vol #:
|
| 44
|
|
|
| C 1413
|
| Illigible
|
| Vol #:
|
| 44
|
|
|
| C 1414
|
| Illigible
|
| Vol #:
|
| 44
|
|
|
| C 1415
|
| M. Leporte
|
| Vol #:
|
| 44
|
|
|
| C 1416
|
| A. Reileen
|
| Vol #:
|
| 44
|
|
|
| C 1417
|
| C. Luckow
|
| Vol #:
|
| 44
|
|
|
| C 1418
|
| E. Drake
|
| Vol #:
|
| 44
|
|
|
| C 1419
|
| R. Jare
|
| Vol #:
|
| 44
|
|
|
| C 1420
|
| C. Cavenagh
|
| Vol #:
|
| 44
|
|
|
| C 1421
|
| Illigible
|
| Vol #:
|
| 44
|
|
|
| C 1422
|
| A. Munor
|
| Vol #:
|
| 44
|
|
|
| C 1423
|
| J. Reiheir
|
| Vol #:
|
| 44
|
|
|
| C 1424
|
| M. Ming
|
| Vol #:
|
| 44
|
|
|
| C 1425
|
| S. Felton
|
| Vol #:
|
| 44
|
|
|
| C 1426
|
| M. Tharense
|
| Vol #:
|
| 45
|
|
|
| C 1427
|
| J. Jacobson
|
| Vol #:
|
| 45
|
|
|
| C 1428
|
| Illigible
|
| Vol #:
|
| 45
|
|
|
| C 1429
|
| R. Wilson
|
| Vol #:
|
| 45
|
|
|
| C 1430
|
| Illigible
|
| Vol #:
|
| 45
|
|
|
| C 1431
|
| G. Ruckow
|
| Vol #:
|
| 45
|
|
|
| C 1432
|
| T. Conlin
|
| Vol #:
|
| 45
|
|
|
| C 1433
|
| A. Brocato
|
| Vol #:
|
| 45
|
|
|
| C 1434
|
| R and L Bloom
|
| Vol #:
|
| 45
|
|
| | | | | | | |
|
|
| C 1435
|
| B. Kelly
|
| Vol #:
|
| 45
|
|
|
| C 1436
|
| T. Dake
|
| Vol #:
|
| 45
|
|
|
| C 1437
|
| P. Kirkman
|
| Vol #:
|
| 45
|
|
|
| C 1438
|
| C. Shannon
|
| Vol #:
|
| 45
|
|
|
| C 1439
|
| J. Shannon
|
| Vol #:
|
| 45
|
|
|
| C 1440
|
| A and M Caldieraro
|
| Vol #:
|
| 45
|
|
|
| C 1441
|
| A. Bruchalski
|
| Vol #:
|
| 45
|
|
|
| C 1442
|
| M. Blackburn
|
| Vol #:
|
| 45
|
|
|
| C 1443
|
| M. Bria
|
| Vol #:
|
| 45
|
|
|
| C 1444
|
| L. Pieper
|
| Vol #:
|
| 45
|
|
|
| C 1445
|
| R. Schafer
|
| Vol #:
|
| 45
|
|
|
| C 1446
|
| M. Cortney
|
| Vol #:
|
| 45
|
|
|
| C 1447
|
| J. Liston
|
| Vol #:
|
| 45
|
|
|
| C 1448
|
| P. Berry
|
| Vol #:
|
| 45
|
|
|
| C 1449
|
| J. Olson
|
| Vol #:
|
| 45
|
|
|
| C 1450
|
| R. Petschauer
|
| Vol #:
|
| 45
|
|
|
| C 1451
|
| E. Berger
|
| Vol #:
|
| 45
|
|
|
| C 1452
|
| D. Kulbartz
|
| Vol #:
|
| 45
|
|
|
| C 1453
|
| J. Fixmur
|
| Vol #:
|
| 45
|
|
|
| C 1454
|
| S. Reilly
|
| Vol #:
|
| 45
|
|
|
| C 1455
|
| C. and S Hill
|
| Vol #:
|
| 45
|
|
|
| C 1456
|
| R. Martin
|
| Vol #:
|
| 45
|
|
|
| C 1457
|
| S. MAxley
|
| Vol #:
|
| 45
|
|
|
| C 1458
|
| M. LaPorta
|
| Vol #:
|
| 45
|
|
|
| C 1459
|
| K. Ford
|
| Vol #:
|
| 45
|
|
|
| C 1460
|
| B. Meier
|
| Vol #:
|
| 45
|
|
|
| C 1461
|
| E. Croce
|
| Vol #:
|
| 45
|
|
|
| C 1462
|
| V. Kasper
|
| Vol #:
|
| 45
|
|
|
| C 1463
|
| N. Weiss
|
| Vol #:
|
| 45
|
|
|
| C 1464
|
| D and R Marsala
|
| Vol #:
|
| 45
|
|
|
| C 1465
|
| M. McGinty
|
| Vol #:
|
| 45
|
|
|
| C 1466
|
| M. Iannitello
|
| Vol #:
|
| 45
|
|
|
| C 1467
|
| C. Riesterer
|
| Vol #:
|
| 45
|
|
|
| C 1468
|
| K. Riesterer
|
| Vol #:
|
| 45
|
|
|
| C 1469
|
| J. Riesterer
|
| Vol #:
|
| 45
|
|
|
| C 1470
|
| E. Riesterer
|
| Vol #:
|
| 45
|
|
|
| C 1471
|
| B. Riesterer
|
| Vol #:
|
| 45
|
|
| | | | | | | |
|
|
| C 1472
|
| N. Riesterer
|
| Vol #:
|
| 45
|
|
|
| C 1473
|
| E. Stephens
|
| Vol #:
|
| 45
|
|
|
| C 1474
|
| D. Harte
|
| Vol #:
|
| 45
|
|
|
| C 1475
|
| H. Meany
|
| Vol #:
|
| 45
|
|
|
| C 1476
|
| H. Petullo
|
| Vol #:
|
| 45
|
|
|
| C 1477
|
| D. Arbogast
|
| Vol #:
|
| 45
|
|
|
| C 1478
|
| S. Marincel
|
| Vol #:
|
| 45
|
|
|
| C 1479
|
| M. Klein
|
| Vol #:
|
| 45
|
|
|
| C 1480
|
| B. Moran
|
| Vol #:
|
| 45
|
|
|
| C 1481
|
| R. Puhalla
|
| Vol #:
|
| 45
|
|
|
| C 1482
|
| M. Cronauer
|
| Vol #:
|
| 45
|
|
|
| C 1483
|
| V. Davies
|
| Vol #:
|
| 45
|
|
|
| C 1484
|
| B. Kearney, RN
|
| Vol #:
|
| 45
|
|
|
| C 1485
|
| M. Kimes, RN
|
| Vol #:
|
| 45
|
|
|
| C 1486
|
| L. Maurizio
|
| Vol #:
|
| 45
|
|
|
| C 1487
|
| J. Moran
|
| Vol #:
|
| 45
|
|
|
| C 1488
|
| F. McHale
|
| Vol #:
|
| 45
|
|
|
| C 1489
|
| B. Sitar
|
| Vol #:
|
| 45
|
|
|
| C 1490
|
| M. LaLonde
|
| Vol #:
|
| 45
|
|
|
| C 1491
|
| M. Bonnell
|
| Vol #:
|
| 45
|
|
|
| C 1492
|
| R. Sparks
|
| Vol #:
|
| 45
|
|
|
| C 1493
|
| A. Schuck
|
| Vol #:
|
| 45
|
|
|
| C 1494
|
| T. Giannotti
|
| Vol #:
|
| 45
|
|
|
| C 1495
|
| E. Race
|
| Vol #:
|
| 45
|
|
|
| C 1496
|
| D. Pogor
|
| Vol #:
|
| 45
|
|
|
| C 1497
|
| N. Anderton
|
| Vol #:
|
| 45
|
|
|
| C 1498
|
| A. McNichol et al.
|
| Vol #:
|
| 45
|
|
|
| C 1499
|
| A. Clift
|
| Vol #:
|
| 45
|
|
|
| C 1500
|
| M. Good
|
| Vol #:
|
| 45
|
|
|
| C 1501
|
| S. Clemens
|
| Vol #:
|
| 45
|
|
|
| C 1502
|
| A. Drost
|
| Vol #:
|
| 45
|
|
|
| C 1503
|
| T. Sears
|
| Vol #:
|
| 45
|
|
|
| C 1504
|
| D. Foley
|
| Vol #:
|
| 45
|
|
|
| C 1505
|
| J. Murray
|
| Vol #:
|
| 45
|
|
|
| C 1506
|
| A. Bourek
|
| Vol #:
|
| 45
|
|
|
| C 1507
|
| C. MArtin
|
| Vol #:
|
| 45
|
|
|
| C 1508
|
| E. Berrodin
|
| Vol #:
|
| 45
|
|
| | | | | | | |
|
|
| C 1509
|
| F. Roloff
|
| Vol #:
|
| 45
|
|
|
| C 1510
|
| M. Harmon
|
| Vol #:
|
| 45
|
|
|
| C 1511
|
| R. Korenkiewicz
|
| Vol #:
|
| 45
|
|
|
| C 1512
|
| A. Lindberg
|
| Vol #:
|
| 45
|
|
|
| C 1513
|
| L. Jennings
|
| Vol #:
|
| 45
|
|
|
| C 1514
|
| T. Fullenkemf
|
| Vol #:
|
| 45
|
|
|
| C 1515
|
| J. Feldpausch
|
| Vol #:
|
| 45
|
|
|
| C 1516
|
| E. Metzler
|
| Vol #:
|
| 45
|
|
|
| C 1517
|
| J and A Meis
|
| Vol #:
|
| 45
|
|
|
| C 1518
|
| J. Nicholson
|
| Vol #:
|
| 45
|
|
|
| C 1519
|
| No signature
|
| Vol #:
|
| 45
|
|
|
| C 1520
|
| C. Serafin
|
| Vol #:
|
| 45
|
|
|
| C 1521
|
| S. NAseman
|
| Vol #:
|
| 45
|
|
|
| C 1522
|
| P. Brown
|
| Vol #:
|
| 45
|
|
|
| C 1523
|
| M. Tritz
|
| Vol #:
|
| 45
|
|
|
| C 1524
|
| J and J Donahoe
|
| Vol #:
|
| 45
|
|
|
| C 1525
|
| J. McCarty
|
| Vol #:
|
| 45
|
|
|
| C 1526
|
| A. Durkin
|
| Vol #:
|
| 46
|
|
|
| C 1527
|
| M. Eisele
|
| Vol #:
|
| 46
|
|
|
| C 1528
|
| E. Terwilliger
|
| Vol #:
|
| 46
|
|
|
| C 1529
|
| M. Christman
|
| Vol #:
|
| 46
|
|
|
| C 1530
|
| L. Benz
|
| Vol #:
|
| 46
|
|
|
| C 1531
|
| Mr and Mrs J. Holschuh
|
| Vol #:
|
| 46
|
|
|
| C 1532
|
| J. Kettunen
|
| Vol #:
|
| 46
|
|
|
| C 1533
|
| J. Silverberg
|
| Vol #:
|
| 46
|
|
|
| C 1534
|
| E. Rocks
|
| Vol #:
|
| 46
|
|
|
| C 1535
|
| R. Cowles
|
| Vol #:
|
| 46
|
|
|
| C 1536
|
| C. Lavallee
|
| Vol #:
|
| 46
|
|
|
| C 1537
|
| R. Bowen
|
| Vol #:
|
| 46
|
|
|
| C 1538
|
| J. Hart, Jr.
|
| Vol #:
|
| 46
|
|
|
| C 1539
|
| L. Mitoraj
|
| Vol #:
|
| 46
|
|
|
| C 1540
|
| L. Kozlowski, MD
|
| Vol #:
|
| 46
|
|
|
| C 1541
|
| M. Pauwels
|
| Vol #:
|
| 46
|
|
|
| C 1542
|
| G. Korman
|
| Vol #:
|
| 46
|
|
|
| C 1543
|
| S. Vrazel
|
| Vol #:
|
| 46
|
|
|
| C 1544
|
| M. George
|
| Vol #:
|
| 46
|
|
|
| C 1545
|
| No siganture
|
| Vol #:
|
| 46
|
|
| | | | | | | |
|
|
| C 1546
|
| M. Klueiner
|
| Vol #:
|
| 46
|
|
|
| C 1547
|
| A. Kraengel
|
| Vol #:
|
| 46
|
|
|
| C 1548
|
| J. Carey
|
| Vol #:
|
| 46
|
|
|
| C 1549
|
| A. Kraengel
|
| Vol #:
|
| 46
|
|
|
| C 1550
|
| Children of God for Life
|
| Vol #:
|
| 46
|
|
|
| C 1551
|
| Children of God for Life
|
| Vol #:
|
| 46
|
|
|
| C 1552
|
| Children of God for Life
|
| Vol #:
|
| 47
|
|
|
| C 1553
|
| J. Kettunen
|
| Vol #:
|
| 46
|
|
|
| C 1554
|
| C. Stensvad
|
| Vol #:
|
| 46
|
|
|
| C 1555
|
| G. Ziccardi
|
| Vol #:
|
| 46
|
|
|
| C 1556
|
| H. Mack
|
| Vol #:
|
| 46
|
|
|
| C 1557
|
| J. Jalbert
|
| Vol #:
|
| 46
|
|
|
| C 1558
|
| N. Blind
|
| Vol #:
|
| 46
|
|
|
| C 1559
|
| H and S Reilly
|
| Vol #:
|
| 46
|
|
|
| C 1560
|
| Form Letters
|
| Vol #:
|
| 50
|
|
|
| C 1561
|
| Form Letters
|
| Vol #:
|
| 51
|
|
|
| C 1562
|
| Form Letters
|
| Vol #:
|
| 52
|
|
|
| C 1563
|
| Form Letters
|
| Vol #:
|
| 53
|
|
|
| C 1564
|
| Form Letters
|
| Vol #:
|
| 54
|
|
|
| C 1565
|
| Form Letters
|
| Vol #:
|
| 55
|
|
|
| C 1566
|
| Form Letters
|
| Vol #:
|
| 56
|
|
|
| C 1567
|
| Form Letters
|
| Vol #:
|
| 57
|
|
|
| C 1568
|
| Form Letters
|
| Vol #:
|
| 58
|
|
|
| C 1569
|
| Form Letters
|
| Vol #:
|
| 59
|
|
|
| C 1570
|
| Form Letters
|
| Vol #:
|
| 60
|
|
|
| C 1571
|
| Form Letters
|
| Vol #:
|
| 61
|
|
|
| C 1572
|
| Form Letters
|
| Vol #:
|
| 62
|
|
|
| C 1573
|
| Form Letters
|
| Vol #:
|
| 63
|
|
|
| C 1574
|
| Form Letters
|
| Vol #:
|
| 64
|
|
|
| C 1575
|
| Form Letters
|
| Vol #:
|
| 65
|
|
|
| C 1576
|
| Form Letters
|
| Vol #:
|
| 66
|
|
|
| C 1577
|
| Form Letters
|
| Vol #:
|
| 67
|
|
|
| C 1578
|
| Form Letters
|
| Vol #:
|
| 68
|
|
|
| C 1579
|
| Form Letters
|
| Vol #:
|
| 69
|
|
|
| C 1580
|
| Form Letters
|
| Vol #:
|
| 70
|
|
|
| C 1581
|
| Form Letters
|
| Vol #:
|
| 71
|
|
|
| C 1582
|
| Form Letters
|
| Vol #:
|
| 72
|
|
| | | | | | | | |
|
|
| C 1583
|
| Form Letters
|
| Vol #:
|
| 73
|
|
|
| C 1584
|
| Form Letters
|
| Vol #:
|
| 74
|
|
|
| 2006D-0463
|
| Guidance for Industry on Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment; Availability
|
|
|
| EMC 1
|
| Merck & Co., Inc.
|
| Vol #:
|
| 1
|
|
|
| 2006E-0034
|
| Patent Extension Application for PREVICOX (firocoxib), U. S. Patent No. 5,981,576
|
|
|
| LET 3
|
| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
|
| Vol #:
|
| 1
|
|
|
| 2006E-0046
|
| Patent Extension Application for Onyx Liquid Embolic System (LES), U.S. Patent No. 5,667,767
|
|
|
| LET 3
|
| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
|
| Vol #:
|
| 1
|
|
|
| 2006E-0240
|
| Patent Extension Application for REVLIMID (lenalidomide), U.S. Patent No. 5,635,517
|
|
|
| LET 3
|
| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
|
| Vol #:
|
| 1
|
|
|
| 2006E-0478
|
| Patent Extension Application for NovoLog insulin aspart (rDNA origin) injection, U.S. Patent No. 5,618,913
|
|
|
| LET 4
|
| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
|
| Vol #:
|
| 1
|
|
|
| 2006N-0036
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur
|
|
|
|
|
|
|
| EMC 15
|
| M. Bechtel
|
| Vol #:
|
| 1
|
|
|
| EMC 16
|
| B. Kimmel
|
| Vol #:
|
| 1
|
|
|
| 2006N-0416
|
| Use of Ozone-Depleting Substances; Removal of Essential Use Designations
|
|
|
| EA 1
|
| Environmental Assessment
|
| Vol #:
|
| 1
|
|
|
| FONS 1
|
| Finding of No Significant Impact
|
| Vol #:
|
| 1
|
|
|
| 2006P-0415
|
| Petition Seeking Regulation of Cloned Animals
|
|
|
| EMC 38
|
| Form Letters
|
| Vol #:
|
| 6
|
|
|
| EMC 39
|
| D. Nocita
|
| Vol #:
|
| 5
|
|
|
| EMC 40
|
| A. Woody
|
| Vol #:
|
| 5
|
|
|
| EMC 41
|
| M. Schrader
|
| Vol #:
|
| 5
|
|
|
| EMC 42
|
| R. Toomim
|
| Vol #:
|
| 5
|
|
|
| EMC 43
|
| T. Markovich
|
| Vol #:
|
| 5
|
|
|
| EMC 44
|
| R. Hyde
|
| Vol #:
|
| 5
|
|
|
| EMC 45
|
| San Jose State University-Soc. Department
|
| Vol #:
|
| 5
|
|
|
| EMC 46
|
| C. Shetterly
|
| Vol #:
|
| 5
|
|
|
| EMC 47
|
| G. Ruiz
|
| Vol #:
|
| 5
|
|
|
| EMC 48
|
| J. Courtney
|
| Vol #:
|
| 5
|
|
|
| EMC 49
|
| D. Morano
|
| Vol #:
|
| 5
|
|
| | | | | | | |
|
|
| EMC 50
|
| B. Gorlach
|
| Vol #:
|
| 5
|
|
|
| EMC 51
|
| K. Justesen
|
| Vol #:
|
| 5
|
|
|
| EMC 52
|
| J. Goldsberry
|
| Vol #:
|
| 5
|
|
|
| EMC 53
|
| J. Lorraine
|
| Vol #:
|
| 5
|
|
|
| EMC 54
|
| M. Caprio
|
| Vol #:
|
| 5
|
|
|
| EMC 55
|
| L. Connor
|
| Vol #:
|
| 5
|
|
|
| EMC 56
|
| B. Centofante
|
| Vol #:
|
| 5
|
|
|
| EMC 57
|
| L. Stubbs
|
| Vol #:
|
| 5
|
|
|
| EMC 58
|
| E. Kearns
|
| Vol #:
|
| 5
|
|
|
| EMC 59
|
| K. Duke
|
| Vol #:
|
| 5
|
|
|
| EMC 60
|
| W. Teague
|
| Vol #:
|
| 5
|
|
|
| EMC 61
|
| J. Bushman
|
| Vol #:
|
| 5
|
|
|
| EMC 62
|
| S. Donnelly
|
| Vol #:
|
| 5
|
|
|
| EMC 63
|
| B. Brown
|
| Vol #:
|
| 5
|
|
|
| EMC 64
|
| T. Edminister
|
| Vol #:
|
| 5
|
|
|