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| Dockets Entered
On July 16, 2004
Table of Contents
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| Docket #
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| Title
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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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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| 1999P-4613
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| Revoke the Regulation That Approved Posilac
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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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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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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-0324
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| New Animal Drugs; Removal of Obsolete and Redundant Regulations
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| 2003P-0126
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| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
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| 2003P-0387
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| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| 2004N-0133
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| Part 11, Electronic Record; Electronic Signatures; Public Meeting
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| 2004N-0205
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| Furan in food; thermal treatment
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| 2004N-0242
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| Institutional Review Boards; Registration Requirements
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| 2004N-0257
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| Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
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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-0105
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| Nutrient Content Claim: Total Carbohydrate Content of Foods
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| 2004P-0107
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| Nutrient Content Claim: Carbohydrate Content of Foods
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| 2004P-0110
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| Nutrient Content Claim: Carbohydrate Content of Foods
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| 2004P-0297
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| Nutrient Content Claim: Define Terms Low Carbohydrate, Reduced Carbohydrate and Carbohydreate Free
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| 2004P-0298
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| Nutrient Content Claims for the Carbohydrate Content of Food
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| 2004P-0299
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| Nutrient Content Claims for Carbonhydrates
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| 2004P-0321
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| ANDA For Benzonatate Capsules USP, 150 mg
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| 2004S-0170
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| Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
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| 1994P-0390
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| Adopt Amendments Governing Health Claims & Nutrient Claims
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| EMC
7
Attachment
1, 2
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| Government of China
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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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| EMC
7
Attachment
1, 2
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| Government of China
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| Vol #:
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| 9
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| | | | | | | | |
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| EMC 548
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| R. Mehra
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| Vol #:
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| 24
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| EMC 789
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| S. Arday
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| Vol #:
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| 33
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| 1999P-4613
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| Revoke the Regulation That Approved Posilac
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| EMC 2426
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| E. Dehart
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| Vol #:
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| 46
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| EMC 2427
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| T. Dehart
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| Vol #:
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| 46
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| EMC 164
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| M. Isakson
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| Vol #:
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| 2
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| EMC 165
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| M. Perez
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| Vol #:
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| 2
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| EMC 166
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| L. Miller
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| Vol #:
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| 2
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| EMC 167
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| Dr. J. Bloom
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| Vol #:
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| 2
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| EMC 168
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| J. Janicki
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| Vol #:
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| 2
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| EMC 169
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| Mr and Mrs F. Wall
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| Vol #:
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| 2
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| EMC 170
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| R. Calabro
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| Vol #:
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| 2
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| EMC 171
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| S. Bennett
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| Vol #:
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| 2
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| EMC 172
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| H. Loesch
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| Vol #:
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| 2
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EXB 297
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| EXB 298
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| EXB 299
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| EXB 300
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| EXB 301
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| EXB 302
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| EXB 303
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| EXB 304
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| EXB 305
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| EXB 306
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| EXB 307
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| EXB 308
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| EXB 309
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| EXB 310
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| EXB 311
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| EXB 312
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| EXB 313
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| | | | | | | | |
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| EXB 314
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| EXB 315
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| EXB 316
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| REX 1
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| Center for Veterinary Medicine
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| Vol #:
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| 444
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| REX 2
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| Bayer Corporation & Animal Health Institute
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| Vol #:
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| 444
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| EMC
213
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| National Customs Brokers and Forwarders Assn of America, Inc. (NCBFAA)
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| Vol #:
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| 30
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| EMC
214
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| Kaft Foods Global, Inc. (Kraft)
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| Vol #:
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| 30
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| EMC
215
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| Government of Japan
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| Vol #:
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| 30
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|
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| EMC
216
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| American Assn of Exporters and Importers (AAEI)
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| Vol #:
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| 30
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| EMC
217
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| American Assn of Exporters and Importers (AAEI)
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| Vol #:
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| 30
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| EMC
218
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| International Dairy Foods Assn (IDFA)
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| Vol #:
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| 30
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| EMC
219
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| National Coffee Assn of USA (NCA)
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| Vol #:
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| 30
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| EMC 220
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| C. McGlennon
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| Vol #:
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| 30
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| EMC
221
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| New York/New Jersey Foreign Freight Forwarders and Brokers Assn, Inc. (NYFFBA)
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| Vol #:
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| 30
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| EMC
222
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| Abbott Laboratories (Abbott)
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| Vol #:
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| 30
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| EMC
223
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| Canadian Trucking Alliance (CTA)
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| Vol #:
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| 30
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| EMC
224
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| International Bottled Water Assn (IBWA)
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| Vol #:
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| 30
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| EMC
225
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| National Assn of Beverage Importers, Inc. et al
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| Vol #:
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| 30
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|
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| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
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| EMC 347
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| Dr. J Bowen
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| Vol #:
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| 6
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| EMC 348
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| Dr. J Bowen
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| Vol #:
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| 6
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|
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| EMC 349
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| R. Murray
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| Vol #:
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| 6
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|
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| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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|
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| EMC 244
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| F. Copp
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| Vol #:
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| 8
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| EMC 245
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| J. Burroughs
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| Vol #:
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| 8
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| EMC 246
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| F. Masterson
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| Vol #:
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| 8
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| EMC 247
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| J. Sobanik
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| Vol #:
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| 8
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| EMC 248
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| A. Davis
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| Vol #:
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| 8
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| EMC 249
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| M. Cherbaka
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| Vol #:
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| 8
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| EMC 250
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| K. Ross
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| Vol #:
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| 8
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| EMC 251
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| P. Juengst
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| Vol #:
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| 8
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| EMC 252
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| No signature
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| Vol #:
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| 8
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| EMC 253
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| R. Zelinsky
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| Vol #:
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| 8
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|
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| EMC 254
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| C. Metcalfe
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| Vol #:
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| 8
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|
| | | | | | | | |
|
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| 2003P-0387
|
| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
|
|
|
| EMC
7
|
| HFD-1 to American Thyroid Assn
|
| Vol #:
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| 5
|
|
|
| 2004N-0081
|
| BSE Risk Materials in Foods and Cosmetics
|
|
|
| EMC 1
|
| T. Singeltary, Sr.
|
| Vol #:
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| 1
|
|
|
| 2004N-0133
|
| Part 11, Electronic Record; Electronic Signatures; Public Meeting
|
|
|
| EMC
59
Attachment
|
| The Dow Chemical Company
|
| Vol #:
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| 5
|
|
|
| EMC
60
|
| Amegen, Inc.
|
| Vol #:
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| 5
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|
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| EMC
61
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| EduQuest, Inc.
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| Vol #:
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| 5
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|
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| EMC
62
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| Medtronic, Inc.
|
| Vol #:
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| 5
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|
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| EMC
63
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| GlaxoSmithKline (GSK)
|
| Vol #:
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| 5
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|
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| EMC
64
|
| Data Quality Research Institute (DQRI)
|
| Vol #:
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| 5
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|
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| EMC
65
|
| ABB Process Solutions
|
| Vol #:
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| 5
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|
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| EMC
66
Presentation
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| Wimmer Systems, Inc.
|
| Vol #:
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| 5
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|
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| EMC
67
Presentation 1, 2
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| Conformity
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| Vol #:
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| 5
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|
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| EMC
68
|
| Alcon Laboratories, Inc.
|
| Vol #:
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| 5
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|
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| EMC
69
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| Pharmaceutical Sourcing Group - Americas
|
| Vol #:
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| 5
|
|
|
| EMC
70
|
| Compressed Gas Assn (CGA)
|
| Vol #:
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| 5
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|
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| EMC
71
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| SEC Associates, Inc.
|
| Vol #:
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| 5
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|
|
| EMC
72
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| America's Blood Centers (ABC)
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| Vol #:
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| 5
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|
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| EMC
73
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| National Grain and Feed Assn
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| Vol #:
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| 5
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|
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| EMC
74
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| Americas's Blood Centers
|
| Vol #:
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| 5
|
|
|
| 2004N-0205
|
| Furan in food; thermal treatment
|
|
|
| EMC
1
|
| International Formula Council (IFC)
|
| Vol #:
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| 2
|
|
|
| 2004N-0242
|
| Institutional Review Boards; Registration Requirements
|
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
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| 1
|
|
|
| 2004N-0257
|
| Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
|
|
|
| EMC 1
|
| T. Thomas,PE,PhD
|
| Vol #:
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| 2
|
|
|
| 2004N-0258
|
| Produce Safety from Production to Consumption: An Action Plan to Minimize Foodborne Illness Associated with Fresh Produce
|
|
|
| EMC
1
|
| International Speciality Supply
|
| Vol #:
|
| 1
|
|
|
| 2004N-0264
|
| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
|
|
|
| EMC 1
|
| T. Singeltary, Sr.
|
| Vol #:
|
| 1
|
|
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| EMC 2
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| D. Sherman
|
| Vol #:
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| 1
|
|
| | | | | | | | |
|
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| EMC 3
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| N and T Howard
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| Vol #:
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| 1
|
|
|
| 2004P-0105
|
| Nutrient Content Claim: Total Carbohydrate Content of Foods
|
|
|
| EMC
1
|
| American Bakers Assn (ABA)
|
| Vol #:
|
| 1
|
|
|
| 2004P-0107
|
| Nutrient Content Claim: Carbohydrate Content of Foods
|
|
|
| EMC
1
|
| American Bakers Assn (ABA)
|
| Vol #:
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| 1
|
|
|
| 2004P-0110
|
| Nutrient Content Claim: Carbohydrate Content of Foods
|
|
|
| EMC
1
|
| American Bakers Assn (ABA)
|
| Vol #:
|
| 1
|
|
|
| 2004P-0297
|
| Nutrient Content Claim: Define Terms Low Carbohydrate, Reduced Carbohydrate and Carbohydreate Free
|
|
|
| ACK
1
|
| HFS-800 to Center for Science in the Public Interest (CSPI)
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| Vol #:
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| 1
|
|
|
| CP
1
Attachment
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| Center for Science in the Public Interest (CSPI)
|
| Vol #:
|
| 1
|
|
|
| 2004P-0298
|
| Nutrient Content Claims for the Carbohydrate Content of Food
|
|
|
| AST 1
|
| HFS-800 to Unilever United States Inc
|
| Vol #:
|
| 1
|
|
|
| CP
1
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| Unilever United States Inc
|
| Vol #:
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| 1
|
|
|
| MM
1
|
| Between FDA and Unilever United States Inc
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| Vol #:
|
| 2
|
|
|
| SUP
1
|
| Unilever United States Inc
|
| Vol #:
|
| 2
|
|
|
| SUP
2
|
| Unilever United States Inc
|
| Vol #:
|
| 2
|
|
|
| 2004P-0299
|
| Nutrient Content Claims for Carbonhydrates
|
|
|
| ACK
1
|
| HFS-832 to Frito-Lay Inc
|
| Vol #:
|
| 1
|
|
|
| CP
1
|
| Frito-Lay Inc
|
| Vol #:
|
| 1
|
|
|
| 2004P-0321
|
| ANDA For Benzonatate Capsules USP, 150 mg
|
|
|
| ACK 1
|
| HFA-305 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
| CP
1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004S-0170
|
| Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
|
|
|
| EMC
25
|
| American Dental Assn et al
|
| Vol #:
|
| 3
|
|