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| Dockets Entered
On October 26, 2004
Table of Contents
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| Docket #
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| Title
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| 1978N-0064
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| OTC Antiperspirant
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| 1987F-0179
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| Sucrose polyester as
replacement for fats & oil in food
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| 1994P-0390
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| Adopt Amendments Governing
Health Claims & Nutrient Claims
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| 1995P-0241
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| Implied Nutrient Content
Claim 'Healthy' & Health Claims
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| 1998P-0151
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| Introduction Of Downed
Cattle Into The Food Supply
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| 1999P-5106
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| Identify Sources of
Natural Flavorings
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| 2001N-0463
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| Workshop on Preclinical
Testing for Endovascular Grafts
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| 2001P-0075
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| Switch Status of Emergency
Contraceptives from Rx to OTC
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| 2002N-0291
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| Proposal to Debar Baldev
Raj Bhutani;Notice of Opportunity
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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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| 2003N-0312
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| Discussion of Animal
Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program
for the Manufacture and Distribution of Animal Feeds
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| 2003P-0176
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| Follow-Up Approval of
Therapeutic Protein Products
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| 2003P-0270
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| Prohibit False and Misleading
Labeling
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| 2004D-0343
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| Hospital Bed System Dimensional
Guidance to Reduce Entrapment
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| 2004D-0440
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| Guidance for Industry on Computerized
Systems Used in Clinical Trials
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| 2004D-0476
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| Draft guidance customs
devices, for filing pursuant to 21 CFR 10.20
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| 2004N-0049
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| Agency Information Collection
Activities; Proposed Collection; Comment Request; Control of Communicable
Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain
Other Animals
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| 2004N-0355
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| Scientific Considerations
Related to Developing Follow-on Protein Products
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| 2004N-0408
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| Regulatory Site Visit
Training Program
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| 2004N-0441
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| Agency Information Collection
Activities; Proposed Collection; Comment Request; Application For FDA
Approval to Market a New Drug
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| 2004N-0454
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| Dietary Supplements;
Premarket Notification for New Dietary Ingredient Notifications; Public
Meeting
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| 2004P-0171
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| Standards for 'Similarity'
or 'Sameness' of Biotechnology-Derived Products
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| 2004P-0276
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| Initiate proceedings
to permit Computerized Thermal Imaging, Inc. (CTI) to supplement the
administrative record in connection with CTI's premarket approval application
in P010035
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| 2004P-0349
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| Action on Products containing
added Mercury
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| 2004P-0429
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| Revoke 21 C.F.R. Part
11 in its entirety, and purse implementation of electronic record and
signature
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| 2004P-0464
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| Vitamin D and Calcium
and Reduced Risk of Osteoporosis
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| 2004P-0472
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| refuse final approval
to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current
proposed labeling
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| 2004P-0473
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| Labeling Claims Using
Net Effective Carbohydrates and Similar Terms
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| 2004Q-0072
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| QHC Eggs w/Enhanced
omega-3 fatty acid content and reduced risk of heart disease and sudden
fatal heart attack
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| 2004Q-0151
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| Qualified Health Claim
(QHC): soy protein and cancer
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| 2004S-0212
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| Pandemic Influenza Preparedness
and Response Plan
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| 2004V-0475
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| Laser Light Show
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| 1978N-0064
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| OTC Antiperspirant
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| EMC 1
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| B. Sachau
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| Vol #:
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| 53
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| 1987F-0179
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| Sucrose polyester
as replacement for fats & oil in food
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| RPT
6
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| Center for Science in
the Public Interest (CSPI)
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| Vol #:
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| 42
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| 1994P-0390
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| Adopt Amendments
Governing Health Claims & Nutrient Claims
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| | | | | | | | |
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| C
67
Tab A
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| Carbolite Foods, Inc. (Carbolite)
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| Vol #:
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| 7
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| 1995P-0241
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| Implied Nutrient Content Claim 'Healthy' & Health Claims
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| C
84
Tab A
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| Carbolite Foods, Inc. (Carbolite)
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| Vol #:
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| 9
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| EMC 4287
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| P. Reed
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| Vol #:
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| 320
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| EMC 209
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| Y. Baker
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| Vol #:
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| 3
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| 2001N-0463
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| Workshop on Preclinical Testing for Endovascular Grafts
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| TR
3
part 2, part
3, part 4
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| Transcript of the July 28, 2004 Workshop
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| Vol #:
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| 3
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| TR
4
Part 2, part
3
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| Transcript of the July 29, 2004 Workshop
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| Vol #:
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| 4
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| C 2039
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| J. Mueller, MD
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| Vol #:
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| 295
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| EC 820
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| Mrs. MELINDA BOWLING
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| Vol #:
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| 163
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| EMC 10887
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| J. Manders
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| Vol #:
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| 294
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| EMC 10888
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| A. Witt
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| Vol #:
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| 294
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| EMC 10889
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| E. Todd
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| Vol #:
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| 294
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| EMC 10890
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| A. Miller
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| Vol #:
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| 294
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| EMC 10891
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| A. Bachan
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| Vol #:
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| 294
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| EMC 10892
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| K. Brown
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| Vol #:
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| 294
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| EMC 10893
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| K. Mendez
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| Vol #:
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| 294
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| EMC 10894
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| M. Chisum
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| Vol #:
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| 294
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| EMC 10895
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| J. Nichols
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| Vol #:
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| 294
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| EMC 10896
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| L. Peterson
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| Vol #:
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| 294
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| EMC 10897
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| C. Jack
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| Vol #:
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| 294
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| EMC 10898
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| K. Kimberling
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| Vol #:
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| 294
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| EMC 10899
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| F. Zamora
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| Vol #:
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| 294
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| EMC 10900
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| K. Seaber
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| Vol #:
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| 294
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| EMC 10901
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| K. Fearnley
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| Vol #:
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| 294
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| EMC 10902
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| E. Taylor
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| Vol #:
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| 294
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| EMC 10903
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| M. Niles
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| Vol #:
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| 294
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| EMC 10904
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| A. Belton
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| Vol #:
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| 294
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| EMC 10905
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| A. Beach
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| Vol #:
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| 294
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| EMC 10906
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| C. Elkasim
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| Vol #:
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| 294
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| EMC 10907
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| K. McLeran
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| Vol #:
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| 294
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| C 80
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| J. Thompson
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| Vol #:
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| 9
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| 2004D-0343
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| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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| EC 6
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| Masonic Pathways
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| Vol #:
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| 1
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| EC
7
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| Metropolitan Chicago Healthcare Council
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| Vol #:
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| 1
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| 2004D-0440
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| Guidance for Industry on Computerized Systems Used in Clinical Trials
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| EC
1
Attachment
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| CRF Inc.
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| Vol #:
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| 1
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| 2004D-0476
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| Draft guidance customs devices, for filing pursuant to 21 CFR 10.20
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| GDL
1
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| AGA Medical Corporation
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| Vol #:
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| 1
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| 2004N-0049
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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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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| 2004N-0330
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| Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
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| EC 52
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| Mrs. Kristin Falco
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| Vol #:
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| 2
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| EC
9
Attachment
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| Pharmaceutical Scientist Inc
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| Vol #:
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| 1
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| TR
1
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| Transcripts
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| Vol #:
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| 2
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| 2004N-0408
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| Regulatory Site Visit Training Program
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| EC 7
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| St. Jude Childrens Research Hospital
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| Vol #:
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| 1
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| EC 8
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| SICOR, Inc.
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| Vol #:
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| 1
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| EC 9
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| LifeCell Corporation
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| Vol #:
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| 1
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| EC 10
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| Indiana Blood Center
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| Vol #:
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| 1
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| EC 11
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| Mayo Clinic Rochester Transfusion Medicine
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| Vol #:
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| 1
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| EC 12
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| Neuronyx, Inc.
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| Vol #:
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| 1
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| EC 13
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| Xcyte Therapies
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| Vol #:
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| 1
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| EC
14
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| Johns Hopkins Hospital and University
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| Vol #:
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| 1
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| EC 15
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| University of Texas MD Anderson Cancer Center
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| Vol #:
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| 1
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| EMC
2
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| Panacea Biotec Ltd.
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| Vol #:
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| 1
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| EMC
3
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| Merck & Co., Inc.
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| Vol #:
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| 1
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| 2004N-0441
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Application For FDA Approval to Market a New Drug
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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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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| C 1
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| T. Tiedt, PhD
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| Vol #:
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| 1
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| EMC 1
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| A. Green
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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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|
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| 2004P-0171
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| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
|
|
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| EMC
2
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| University of California
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| Vol #:
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| 1
|
|
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| 2004P-0276
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| Initiate proceedings to permit Computerized Thermal Imaging, Inc. (CTI) to supplement the administrative record in connection with CTI's premarket approval application in P010035
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| PDN
1
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| HF-22 to Sidley Austin Brown & Wood LLP
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| Vol #:
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| 2
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|
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| 2004P-0349
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| Action on Products containing added Mercury
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| EC 20
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| Ms. Christine Ewton
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| Vol #:
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| 1
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|
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| EMC 6
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| J. Masuda
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| Vol #:
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| 1
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| 2004P-0351
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| Change the labeling and take further action to address the association of Viagra (Sildenafil) use and increased STD transmission, including HIV infection
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| EC 5
|
| Mr. Steve Anderson
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| Vol #:
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| 1
|
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| 2004P-0429
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| Revoke 21 C.F.R. Part 11 in its entirety, and purse implementation of electronic record and signature
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| C
2
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| Society of Quality Assurance Computer Validation Initiative Committee (CVIC)
|
| Vol #:
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| 1
|
|
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| 2004P-0464
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| Vitamin D and Calcium and Reduced Risk of Osteoporosis
|
|
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| LET
1
|
| HFS-800 to Johnson Nutrition Solutions LLC
|
| Vol #:
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| 9
|
|
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| 2004P-0472
|
| refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling
|
|
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| CP
1
Attached CV
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| Dr. Daniel Brookoff and Dr. Eric A. Voth
|
| Vol #:
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| 1
|
|
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| 2004P-0473
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| Labeling Claims Using Net Effective Carbohydrates and Similar Terms
|
|
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| ACK
1
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| HFA-305 to Carbolite Foods, Inc.
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| Vol #:
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| 1
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|
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| CP
1
|
| Carbolite Foods, Inc.
|
| Vol #:
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| 1
|
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| 2004Q-0072
|
| QHC Eggs w/Enhanced omega-3 fatty acid content and reduced risk of heart disease and sudden fatal heart attack
|
|
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| LET
2
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| AAC Consulting Group
|
| Vol #:
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| 4
|
|
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| 2004Q-0151
|
| Qualified Health Claim (QHC): soy protein and cancer
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| LET
2
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| The Solae, LLC
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| Vol #:
|
| 5
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| SUP
1
Attachments
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| The Solae Company
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| Vol #:
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| 5
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|
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| 2004S-0212
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| Pandemic Influenza Preparedness and Response Plan
|
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| EC 7
|
| Dr. Clarence Scott
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| Vol #:
|
| 1
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| EC
8
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| Rensselaer Polytechnic University
|
| Vol #:
|
| 1
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