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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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|
|
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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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|
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| 2004P-0298
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| Nutrient Content Claims for the Carbohydrate Content of Food
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|
|
|
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| 2004P-0299
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| Nutrient Content Claims for Carbonhydrates
|
|
|
|
|
| 2004P-0321
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| ANDA For Benzonatate Capsules USP, 150 mg
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|
|
|
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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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|
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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
|
|
|
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
| | | | | | | | |
|
|
|
|
| EMC 548
|
| R. Mehra
|
| Vol #:
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| 24
|
|
|
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
|
|
|
|
| EMC 789
|
| S. Arday
|
| Vol #:
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| 33
|
|
|
|
|
| 1999P-4613
|
| Revoke the Regulation That Approved Posilac
|
|
|
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|
| EMC 2426
|
| E. Dehart
|
| Vol #:
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| 46
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|
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|
| EMC 2427
|
| T. Dehart
|
| Vol #:
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| 46
|
|
|
|
|
| 1999P-5106
|
| Identify Sources of Natural Flavorings
|
|
|
|
|
| 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
|
| Vol #:
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| 2
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|
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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
|
| Vol #:
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| 2
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|
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|
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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
|
| Vol #:
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| 2
|
|
|
|
|
| EMC 171
|
| S. Bennett
|
| Vol #:
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| 2
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|
|
|
|
| EMC 172
|
| H. Loesch
|
| Vol #:
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| 2
|
|
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
|
|
| EXB 297
|
| Center for Veterinary Medicine
|
| Vol #:
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| 420
|
|
|
|
|
| EXB 298
|
| Center for Veterinary Medicine
|
| Vol #:
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| 420
|
|
|
|
|
| EXB 299
|
| Center for Veterinary Medicine
|
| Vol #:
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| 420
|
|
|
|
|
| EXB 300
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| Center for Veterinary Medicine
|
| Vol #:
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| 420
|
|
|
|
|
| EXB 301
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| Center for Veterinary Medicine
|
| Vol #:
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| 420
|
|
|
|
|
| EXB 302
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| Center for Veterinary Medicine
|
| Vol #:
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| 420
|
|
|
|
|
| EXB 303
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| Center for Veterinary Medicine
|
| Vol #:
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| 420
|
|
|
|
|
| EXB 304
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| Center for Veterinary Medicine
|
| Vol #:
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| 420
|
|
|
|
|
| EXB 305
|
| Center for Veterinary Medicine
|
| Vol #:
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| 420
|
|
|
|
|
| EXB 306
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| Center for Veterinary Medicine
|
| Vol #:
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| 420
|
|
|
|
|
| EXB 307
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| Center for Veterinary Medicine
|
| Vol #:
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| 420
|
|
|
|
|
| EXB 308
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| Center for Veterinary Medicine
|
| Vol #:
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| 420
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|
|
|
|
| EXB 309
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| Center for Veterinary Medicine
|
| Vol #:
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| 420
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|
|
|
|
| EXB 310
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| Center for Veterinary Medicine
|
| Vol #:
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| 420
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|
|
|
|
| EXB 311
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| Center for Veterinary Medicine
|
| Vol #:
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| 420
|
|
|
|
|
| EXB 312
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| Center for Veterinary Medicine
|
| Vol #:
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| 420
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|
|
|
|
| EXB 313
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| Center for Veterinary Medicine
|
| Vol #:
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| 420
|
|
| | | | | | | | |
|
|
|
|
| EXB 314
|
| Center for Veterinary Medicine
|
| Vol #:
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| 420
|
|
|
|
|
| EXB 315
|
| Center for Veterinary Medicine
|
| Vol #:
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| 420
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|
|
|
|
| EXB 316
|
| Center for Veterinary Medicine
|
| Vol #:
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| 420
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|
|
|
|
| REX 1
|
| Center for Veterinary Medicine
|
| Vol #:
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| 444
|
|
|
|
|
| REX 2
|
| Bayer Corporation & Animal Health Institute
|
| Vol #:
|
| 444
|
|
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
|
|
| EMC
213
|
| National Customs Brokers and Forwarders Assn of America, Inc. (NCBFAA)
|
| Vol #:
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| 30
|
|
|
|
|
| EMC
214
|
| Kaft Foods Global, Inc. (Kraft)
|
| Vol #:
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| 30
|
|
|
|
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| EMC
215
|
| Government of Japan
|
| Vol #:
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| 30
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|
|
|
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| EMC
216
|
| American Assn of Exporters and Importers (AAEI)
|
| Vol #:
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| 30
|
|
|
|
|
| EMC
217
|
| American Assn of Exporters and Importers (AAEI)
|
| Vol #:
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| 30
|
|
|
|
|
| EMC
218
|
| International Dairy Foods Assn (IDFA)
|
| Vol #:
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| 30
|
|
|
|
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| EMC
219
|
| National Coffee Assn of USA (NCA)
|
| Vol #:
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| 30
|
|
|
|
|
| EMC 220
|
| C. McGlennon
|
| Vol #:
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| 30
|
|
|
|
|
| EMC
221
|
| New York/New Jersey Foreign Freight Forwarders and Brokers Assn, Inc. (NYFFBA)
|
| Vol #:
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| 30
|
|
|
|
|
| EMC
222
|
| Abbott Laboratories (Abbott)
|
| Vol #:
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| 30
|
|
|
|
|
| EMC
223
|
| Canadian Trucking Alliance (CTA)
|
| Vol #:
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| 30
|
|
|
|
|
| EMC
224
|
| International Bottled Water Assn (IBWA)
|
| Vol #:
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| 30
|
|
|
|
|
| EMC
225
|
| National Assn of Beverage Importers, Inc. et al
|
| Vol #:
|
| 30
|
|
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
|
|
| EMC 347
|
| Dr. J Bowen
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC 348
|
| Dr. J Bowen
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC 349
|
| R. Murray
|
| Vol #:
|
| 6
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| EMC 244
|
| F. Copp
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 245
|
| J. Burroughs
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 246
|
| F. Masterson
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 247
|
| J. Sobanik
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 248
|
| A. Davis
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 249
|
| M. Cherbaka
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 250
|
| K. Ross
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 251
|
| P. Juengst
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 252
|
| No signature
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 253
|
| R. Zelinsky
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 254
|
| C. Metcalfe
|
| Vol #:
|
| 8
|
|
| | | | | | | | |
|
|
|
|
| 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 #:
|
| 5
|
|
|
|
|
| 2004N-0081
|
| BSE Risk Materials in Foods and Cosmetics
|
|
|
|
|
| EMC 1
|
| T. Singeltary, Sr.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0133
|
| Part 11, Electronic Record; Electronic Signatures; Public Meeting
|
|
|
|
|
| EMC
59
Attachment
|
| The Dow Chemical Company
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC
60
|
| Amegen, Inc.
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC
61
|
| EduQuest, Inc.
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC
62
|
| Medtronic, Inc.
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC
63
|
| GlaxoSmithKline (GSK)
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC
64
|
| Data Quality Research Institute (DQRI)
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC
65
|
| ABB Process Solutions
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC
66
Presentation
|
| Wimmer Systems, Inc.
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC
67
Presentation 1, 2
|
| Conformity
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC
68
|
| Alcon Laboratories, Inc.
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC
69
|
| Pharmaceutical Sourcing Group - Americas
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC
70
|
| Compressed Gas Assn (CGA)
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC
71
|
| SEC Associates, Inc.
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC
72
|
| America's Blood Centers (ABC)
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC
73
|
| National Grain and Feed Assn
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC
74
|
| Americas's Blood Centers
|
| Vol #:
|
| 5
|
|
|
|
|
| 2004N-0205
|
| Furan in food; thermal treatment
|
|
|
|
|
| EMC
1
|
| International Formula Council (IFC)
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004N-0242
|
| Institutional Review Boards; Registration Requirements
|
|
|
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 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 #:
|
| 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
|
|
|
|
|
| EMC 2
|
| D. Sherman
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
|
|
| EMC 3
|
| N and T Howard
|
| Vol #:
|
| 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 #:
|
| 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)
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
Attachment
|
| 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
|
| Unilever United States Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| MM
1
|
| Between FDA and Unilever United States Inc
|
| 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
|
|
