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| Dockets Entered
On August 5, 2004
Table of Contents
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| Docket
#
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| Title
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| 1997S-0162
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| 30-Day Structure Function
Claim Notification Letters Dietary
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| 1998N-0359
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| Program priorities/Center for
Food Safety & Applied Nutrition
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| 1998P-0151
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| Introduction Of Downed
Cattle Into The Food Supply
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| 1999P-2630
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| Establish a Daily
Value for "added sugars"
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| 1999P-5106
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| Identify Sources of
Natural Flavorings
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| 2000N-1571
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| Enrofloxacin for Poultry:
Opportunity for Hearing
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| 2001P-0345
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| Listing the color
additive yellow #5 for use in food/Drug
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| 2002P-0317
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| Recall Aspartame as
a Neurotoxic Drug
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| 2003N-0076
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| Food Labeling: Trans
Fatty Acids in Nutrition Labeling; Consumer research to consider possible
footnote statements
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| 2003N-0169
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| Dental Amalgam; Request
for Information
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| 2003N-0338
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| Obesity
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| 2003P-0029
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| Remove metered-dose
inhalers (MDI) containing moiety albuter
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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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| 2004M-0341
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| P030024 - Vitros Immunodiagnostic
Products Anti-HBc Reagent Pack and Vitros Immunodiagnostic Products
Anti-HBc Calibrator
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| 2004M-0342
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| P040008 - VIDAS TPSA
assay
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| 2004M-0345
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| Premarket Approval
for CureLight BroadBand by PhotoCure ASA (Model CureLight 01) P010061
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| 2004N-0181
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| Critical Path Initiative
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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-0351
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| Change the labeling
and take futher action to address the association of Viagra(Sildenafil)
use and increased STD transmission, includig HIV infection
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| 2004P-0353
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| ANDA Suitability for
Famotidine Orally Dissolving Strips 10 mg
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| 2004P-0354
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| CEDIA Sirolimus Assay
as a class II device
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|
|
| 2004S-0270
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| Notice Announcing
Publication of the Report to Congress Entitled Plan for the Transfer
of Responsibility for Medicare Appeals and Soliciting Comments
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|
| 1997S-0162
|
| 30-Day Structure
Function Claim Notification Letters Dietary
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| LET
14161
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| Perrigo Company of
South Carolina
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| Vol #:
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| 123
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| LET
14162
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| Perrigo Company of
South Carolina
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| Vol #:
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| 123
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| LET
14163
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| Perrigo Company of
South Carolina
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| Vol #:
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| 123
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| LET
14164
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| Perrigo Company of
South Carolina
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| Vol #:
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| 123
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| LET
14165
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| Perrigo Company of
South Carolina
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| Vol #:
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| 123
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| LET
14166
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| Solgar Vitamin and
Herbs
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| Vol #:
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| 123
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| LET
14167
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| Solgar Vitamin and
Herb
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| Vol #:
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| 123
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| LET
14168
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| Perrigo Company of
South Carolina
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| Vol #:
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| 123
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| LET
14169
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| Inverness Medical
Nutritionals Group
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| Vol #:
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| 123
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| LET
14170
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| Your Vitamins
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| Vol #:
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| 123
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| LET
14171
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| Source Naturals
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| Vol #:
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| 123
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| LET
14172
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| Source Naturals
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| Vol #:
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| 123
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| LET
14173
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| Source Naturals
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| Vol #:
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| 123
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| LET
14174
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| The Monticello Drug Company
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| Vol #:
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| 123
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| LET
14175
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| EM Hawaii Incorporated
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| Vol #:
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| 123
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| LET
14176
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| IntegrativeTherapeutics Inc.
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| Vol #:
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| 123
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| LET
14177
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| Integrative Therapeutics Inc.
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| Vol #:
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| 123
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| LET
14178
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| Integrative Therapeutics Inc.
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| Vol #:
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| 123
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| LET
14179
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| Integrative Therapeutics Inc.
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| Vol #:
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| 123
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| LET
14180
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| Integrative Therapeutics Inc.
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| Vol #:
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| 123
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| LET
14181
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| Integrative Therapeutics Inc.
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| Vol #:
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| 123
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| LET
14182
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| Enzymatic Therapy
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| Vol #:
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| 123
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| LET
14183
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| Your Vitamins
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| Vol #:
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| 123
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| LET
14184
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| Natreon, Inc.
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| Vol #:
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| 123
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| LET
14185
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| Atkins Nutritionals, Inc.
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| Vol #:
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| 123
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| LET
14186
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| Sierra Mountain Minerals, Inc.
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| Vol #:
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| 123
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| LET
14187
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| Enzmyatic Therapy
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| Vol #:
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| 123
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| LET
14188
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| Pharmavite LLC
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| Vol #:
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| 123
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| 1998N-0359
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| Program priorities/Center
for Food Safety & Applied Nutrition
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| EC 132
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| Mrs. Sonja Kepford
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| Vol #:
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| 9
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| EC 133
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| Ms. Enid Futterman
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| Vol #:
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| 9
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| EC 134
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| Mrs. Donna Spencer
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| Vol #:
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| 9
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| EC 135
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| Dr. Kem Moser
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| Vol #:
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| 9
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| EC 136
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| Ms. Sharon Conti
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| Vol #:
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| 9
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| EC 137
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| Ms. Eleanor Brosius
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| Vol #:
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| 9
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| EC 138
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| Mrs. Karen McFarland
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| Vol #:
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| 9
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| EC 139
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| Mr. Alex Polemeropoulos
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| Vol #:
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| 9
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| EC 140
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| Dr. Matt Barnes
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| Vol #:
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| 9
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| EC 141
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| Mrs. Cynthia Long
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| Vol #:
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| 9
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| EC
142
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| North American Millers' Association
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| Vol #:
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| 9
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| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
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| EMC 4244
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| A. Pariser
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| Vol #:
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| 304
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| EMC 4245
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| J. Potter
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| Vol #:
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| 304
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| EMC 4246
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| R. Briggs
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| Vol #:
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| 304
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|
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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|
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| EMC 791
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| M. Wilson
|
| Vol #:
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| 33
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| EMC 792
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| RM Bramlett
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| Vol #:
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| 33
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| 1999P-5106
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| | | | | | | | |
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| Identify Sources of Natural Flavorings
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| EMC 196
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| P. Brooks
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| Vol #:
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| 2
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| EMC 197
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| N. McLachlin
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| Vol #:
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| 2
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| EMC 198
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| L. McBride
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| Vol #:
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| 2
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| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
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| EXB 449
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| Center for Veterinary Medicine
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| Vol #:
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| 427
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| EXB 450
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| Center for Veterinary Medicine
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| Vol #:
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| 427
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| EXB 451
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| Center for Veterinary Medicine
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| Vol #:
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| 428
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| EXB 452
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| Center for Veterinary Medicine
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| Vol #:
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| 428
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| EXB 453
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| Center for Veterinary Medicine
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| Vol #:
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| 428
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| EXB 454
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| Center for Veterinary Medicine
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| Vol #:
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| 428
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| EXB 455
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| Center for Veterinary Medicine
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| Vol #:
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| 428
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| EXB 456
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| Center for Veterinary Medicine
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| Vol #:
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| 428
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| EXB 457
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| Center for Veterinary Medicine
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| Vol #:
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| 428
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| EXB 458
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| Center for Veterinary Medicine
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| Vol #:
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| 428
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| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
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| EMC 1243
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| Nelson
|
| Vol #:
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| 5
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC
353
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| Mission Possible International
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| Vol #:
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| 6
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| EMC
354
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| Mission Possible International
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| Vol #:
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| 6
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| EMC
355
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| Mission Possible International
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| Vol #:
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| 6
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| EMC
356
Attachment
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| Mission Possible International
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| Vol #:
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| 6
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| EMC
357
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| Mission Possible International
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| Vol #:
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| 6
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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 322
|
| J. Stine
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| Vol #:
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| 8
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| EMC 323
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| I. Kot
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| Vol #:
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| 8
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| EMC 324
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| S. Bullard
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| Vol #:
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| 8
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| EMC 325
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| D. Singleton
|
| Vol #:
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| 8
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| EMC 326
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| D. Nuttall
|
| Vol #:
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| 8
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| 2003N-0169
|
| Dental Amalgam; Request for Information
|
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| EMC
241
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC
242
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC
243
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC
244
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC
245
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC
246
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 247
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| M. Rygg
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| Vol #:
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| 6
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| 2003N-0338
|
| Obesity
|
|
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| EMC
58
|
| Pennington Biomedical Research Center
|
| Vol #:
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| 12
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|
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| EMC
23
|
| American Academy of Allergy, Asthma and Immunology (AAAAI)
|
| Vol #:
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| 2
|
|
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| EMC 24
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| R. Carlson
|
| Vol #:
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| 2
|
|
|
| 2003P-0574
|
| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
|
|
|
| EMC
4
|
| American Scociety for Microbiology (ASM)
|
| Vol #:
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| 2
|
|
|
| 2004M-0341
|
| P030024 - Vitros Immunodiagnostic Products Anti-HBc Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc Calibrator
|
|
|
| AAV
1
|
| Ortho-Clinical Diagnostics, Inc.
|
| Vol #:
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| 1
|
|
|
| 2004M-0342
|
| P040008 - VIDAS TPSA assay
|
|
|
| AAV
1
|
| bioMerieux, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004M-0345
|
| Premarket Approval for CureLight BroadBand by PhotoCure ASA (Model CureLight 01) P010061
|
|
|
| AAV
1
|
| PhotoCure ASA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0181
|
| Critical Path Initiative
|
|
|
| EMC
2
|
| AIDS Vaccine Advocacy Coalition (AVAC)
|
| Vol #:
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| 2
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| EMC
3
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| Plasma Protein Therapeutics Assn (PPTA)
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| Vol #:
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| 2
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| EMC
4
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| Merck & Co., Inc.
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| Vol #:
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| 2
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| EMC
5
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| Amgen, Inc.
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| Vol #:
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| 2
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| EMC
6
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| Marti Nelson Cancer Foundation
|
| Vol #:
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| 2
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| EMC
7
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| American Society of Clinical Oncology
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| Vol #:
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| 2
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| EMC
8
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| American Academy of Orthopaedic Surgeons (AAOS/Academy)
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| Vol #:
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| 2
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| EMC
9
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| Millennium Pharmaceuticals, Inc. (Millennium)
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| Vol #:
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| 2
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| EMC
10
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| Massachusetts Biotechnology Council (MBC)
|
| Vol #:
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| 2
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| EMC
11
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| PBG Consulting
|
| Vol #:
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| 2
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| EMC
12
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| American Society for Microbiology (ASM)
|
| Vol #:
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| 2
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| EMC
13
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| Biotechnology Industry Organization (BIO)
|
| Vol #:
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| 2
|
|
|
| 2004N-0264
|
| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
|
|
|
| EMC
46
Attachment
|
| Cargill, Inc.
|
| Vol #:
|
| 6
|
|
|
| EMC
47
|
| Cargill Animal Nutrition
|
| Vol #:
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| 6
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| | | | | | | | |
|
|
| CP
1
|
| STD Prevention and Control Service
|
| Vol #:
|
| 1
|
|
|
| 2004P-0353
|
| ANDA Suitability for Famotidine Orally Dissolving Strips 10 mg
|
|
|
| ACK
1
|
| HFA-305 to Lachman Consultant Services, Inc.
|
| Vol #:
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| 1
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|
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| CP
1
Attachment 1,
2,
3
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| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004P-0354
|
| CEDIA Sirolimus Assay as a class II device
|
|
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| CP
1
Attachment
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| Microgenics Corporation
|
| Vol #:
|
| 1
|
|
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| PAV
1
|
| Steven I. Gutman
|
| Vol #:
|
| 1
|
|
|
| 2004S-0270
|
| Notice Announcing Publication of the Report to Congress Entitled Plan for the Transfer of Responsibility for Medicare Appeals and Soliciting Comments
|
|
|
| EMC
7
|
| America's Health Insurance Plans
|
| Vol #:
|
| 1
|
|
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| EMC 8
|
| Robin J Arzt
|
| Vol #:
|
| 1
|
|
|
| EMC 9
|
| Robin J Arzt
|
| Vol #:
|
| 1
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|
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| EMC
10
|
| Association of Administrative Law Judges
|
| Vol #:
|
| 1
|
|