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| Dockets Entered
On August 2, 2004
Table of Contents
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| Docket
#
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| Title
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| 1987C-0023
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| SAFE USE OF CARBON BLACK FOR COLORING COSMETICS
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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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| 1997N-0497
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| Allogeneic Peripheral and Placental/ Umbilical Cord Blood
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutritin
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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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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2002E-0342
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| Lea's Shield, U.S. Patent No. 4,703,752
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2002P-0499
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| ANDA Suitability for Metformin Hydrochloride Tablets Oral So
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| 2003D-0558
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| Guidance Levels for Radionuclides in Domestic and Imported Foods
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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-0169
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| Dental Amalgam; Request for Information
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| 2003P-0574
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| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
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| 2004N-0018
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| Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| 2004N-0159
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| Schering Corp. et al.; Withdrawal of Approval of 92 New Drug Applications and 49 Abbreviated New Drug Applications
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| 2004N-0181
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| Critical Path Initiative
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| 2004N-0184
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| Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
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| 2004N-0258
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| Produce Safety from Production to Consumption: An Action Plan to Minimize Foodborne Illness Associated with Fresh Produce
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| 2004P-0051
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| Dyclone (dyclonine hydrochloride) Topical Solution 0.5% and 1.0% (NDA 9-925) was voluntarily withdrawn or withheld from sale for reasons other then safety or efficacy
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| |
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| 1987C-0023
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| SAFE USE OF CARBON BLACK FOR COLORING COSMETICS
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| EA
1
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| Revised environmental Assiessment for Color Additive Petition 7C0208
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| Vol #:
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| 1
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| FONS
1
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| Finding of No significant Impact for Color Additive Petition 7C0208
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| Vol #:
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| 1
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| NFR
1
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| FDA
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| Vol #:
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| 1
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| 1994P-0390
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| Adopt Amendments Governing Health Claims & Nutrient Claims
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| C
66
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| Federal Trade Commission (FTC)
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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
83
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| Federal Trade Commission (FTC)
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| Vol #:
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| 9
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| 1997N-0497
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| Allogeneic Peripheral and Placental/ Umbilical Cord Blood
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| EMC 9954
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| B. Anderson
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| Vol #:
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| 286
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| EMC 9955
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| J. Brown
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| Vol #:
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| 286
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| EMC 9956
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| P. G. Buck
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| Vol #:
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| 286
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| EMC 9957
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| C. DeToma
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| Vol #:
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| 286
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| EMC 9958
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| J. Kahn
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| Vol #:
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| 286
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| EMC 9959
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| J. Davidson
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| Vol #:
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| 286
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| EMC 9960
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| K. Hoerl
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| Vol #:
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| 286
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| 2002E-0342
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| Lea's Shield, U.S. Patent No. 4,703,752
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| N
1
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| FDA
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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
352
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| Mission Possible International
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| Vol #:
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| 6
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| 2002P-0499
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| ANDA Suitability for Metformin Hydrochloride Tablets Oral So
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| LET
2
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| HFD-600 to The Weinberg Group Inc
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| Vol #:
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| 1
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| 2003D-0558
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| Guidance Levels for Radionuclides in Domestic and Imported Foods
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| BKG
2
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| Supporting Document for Guidance Levels for Radionuclides in Domestic and Imported Foods
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| Vol #:
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| 1
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| GDL
2
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| Guideline
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| Vol #:
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| 1
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| NAD
2
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| FDA
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| Vol #:
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| 1
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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 320
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| M. Leckey
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| Vol #:
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| 8
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| EMC 321
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| J. Baxter
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| Vol #:
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| 8
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| 2003N-0169
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| Dental Amalgam; Request for Information
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| EMC
237
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| Power in Numbers, Inc.
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| Vol #:
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| 6
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| EMC
238
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 239
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| M. Rygg
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| Vol #:
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| 6
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| EMC 240
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| M. Rygg
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| Vol #:
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| 6
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| 2003P-0574
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| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
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| C
2
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| Wisconsin Dairy Products Assn, Inc.
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| Vol #:
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| 2
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| 2004N-0018
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| Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
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| EMC 1
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| R. Pickering, PhD., RN
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| Vol #:
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| 1
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| C
3
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| S Foods, Inc.
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| Vol #:
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| 1
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| 2004N-0159
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| Schering Corp. et al.; Withdrawal of Approval of 92 New Drug Applications and 49 Abbreviated New Drug Applications
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| NCR
1
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| FDA
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| Vol #:
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| 1
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| 2004N-0181
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| Critical Path Initiative
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| C
15
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| American Society of Gene Therapy
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| Vol #:
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| 1
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| C
16
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| Cook Group, Inc. (Cook)
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| Vol #:
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| 1
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| C 17
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| M. Magrine
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| Vol #:
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| 1
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| C 18
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| M. Magrine
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| Vol #:
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| 1
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| C
19
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| Society for Women's Health Research
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| Vol #:
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| 1
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| C
20
References
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| Susan Eik Filstead Stroke & Epilepsy Foundation, Inc.
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| Vol #:
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| 1
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| C
21
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| National Electrical Manufacturers Assn (NEMA)
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| Vol #:
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| 1
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| C 22
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| A. and T. Healey
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| Vol #:
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| 1
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| C 23
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| S. Kelly
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| Vol #:
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| 1
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| C 24
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| R. Alter
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| Vol #:
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| 1
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| C 25
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| S. Gaumond
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| Vol #:
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| 1
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| C
26
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| Baxter International, Inc. (Baxter)
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| Vol #:
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| 1
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| C
27
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| Pharmaco-Diagnostics (Rx-Dx) Partnerships Program
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| Vol #:
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| 1
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| C
28
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| California Healthcare Institute
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| Vol #:
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| 1
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| C
29
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| Advanced Medical Technology Assn (AdvaMed)
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| Vol #:
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| 1
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| C
30
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| FasterCures
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| Vol #:
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| 1
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| C
31
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| Novartis Pharmaceuticals Corp.
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| Vol #:
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| 2
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| C 32
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| J and S Healey
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| Vol #:
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| 2
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| C
33
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| International Foundation for Functional Gastrointestinal Disorders
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| Vol #:
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| 2
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| C
34
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| Assn of American Medical Colleges (AAMC)
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| Vol #:
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| 2
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| C
35
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| National Osteoporosis Foundation(NOF) and American Society for Bone and Mineral Resaearch (ASB
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| Vol #:
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| 2
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| EC 7
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| Mrs. Debra Wildrick
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| Vol #:
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| 2
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| EC 8
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| National Electrical Manufacturers Association
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| Vol #:
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| 2
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| EC 9
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| ProSanos Corporation
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| Vol #:
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| 2
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| EC 10
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| IFFGD
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| Vol #:
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| 2
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| EC
11
Attachments
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| invivodata, inc.
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| Vol #:
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| 2
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| EC
12
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| Cystic Fibrosis Foundation
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| Vol #:
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| 2
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| EC 13
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| Cystic Fibrosis Foundation
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| Vol #:
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| 2
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| EC 14
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| Cystic Fibrosis
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| Vol #:
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| 2
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| EC 15
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| Alliance for Aging Research
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| Vol #:
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| 2
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| EC 16
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| University of Wisconsin School of Pharmacy
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| Vol #:
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| 2
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| EC 17
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| Elsevier
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| Vol #:
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| 2
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| EC 18
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| ECRI
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| Vol #:
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| 2
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| EC 19
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| United States Bone and Joint Decade, NFP
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| Vol #:
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| 2
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| EC
20
Attachment
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| National Health Council
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| Vol #:
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| 2
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| EC
21
Attachment
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| Medical Device Manufacturers Association
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| Vol #:
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| 2
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| EC 22
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| Targacept, Inc.
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| Vol #:
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| 2
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| EC 23
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| AIDS Treatment Activist Coalition
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| Vol #:
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| 2
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| EC 24
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| Alzheimer's Association
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| Vol #:
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| 2
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| EC 25
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| PBG Consulting
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| Vol #:
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| 2
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| EC
26
Attachment
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| PBG Consulting
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| Vol #:
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| 2
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| EC 27
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| National Osteoporosis Foundation
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| Vol #:
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| 2
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| EC
28
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| ASCO
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| Vol #:
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| 2
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| EC
29
Attachment 1, 2
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| Parkinson Pipeline Project
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| Vol #:
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| 2
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| EC
30
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| National Osteoporosis Foundation
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| Vol #:
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| 2
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| EC 31
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| National Osteoporosis
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| Vol #:
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| 2
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| EC
32
Attachment
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| PBG Consulting
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| Vol #:
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| 2
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| EC
33
Attachment
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| The ALS Association
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| Vol #:
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| 2
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| EC
34
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| Prostate Cancer Foundation
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| Vol #:
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| 2
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| EC 35
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| Prostate Cancer Foundation
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| Vol #:
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| 2
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| EC 36
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| Prostate Cancer Foundation
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| Vol #:
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| 2
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| EC
37
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| Pancreatic Cancer Action Network
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| Vol #:
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| 2
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| EC 38
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| Battelle
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| Vol #:
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| 2
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| EC 39
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| Targacept, Inc.
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| Vol #:
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| 2
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|
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|
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| 2004N-0184
|
| Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
|
|
|
|
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| EMC
8
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| American Industrial Hygiene Assn (AIHA)
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| Vol #:
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| 2
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|
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| EMC
9
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| National Nutritional Foods Assn (NNFA)
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| Vol #:
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| 2
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| EMC
10
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| National Food Processors Assn (NFPA)
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| Vol #:
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| 2
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|
|
|
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| 2004N-0258
|
| Produce Safety from Production to Consumption: An Action Plan to Minimize Foodborne Illness Associated with Fresh Produce
|
|
|
|
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| TR
1
Continued
|
| Transcript of June 29, 2004 Meeting
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| Vol #:
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| 2
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|
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|
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| TS
1
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| Center for Food Safety and Applied Nutrition
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| Vol #:
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| 1
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| TS
2
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| Centers for Disease Control and PRevention
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| Vol #:
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| 1
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| TS
3
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| Safe Tables Our Priority (STOP)
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| Vol #:
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| 1
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|
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| 2004N-0264
|
| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
|
|
|
|
|
| EMC 17
|
| T. Dulake
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| Vol #:
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| 6
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|
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| EMC 18
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| C. Robson
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| Vol #:
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| 6
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|
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| EMC 19
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| S. McGowen
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| Vol #:
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| 6
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| EMC 20
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| C. Lickteig
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| Vol #:
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| 6
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|
