| | | | | | | | | | |
|
| |
|
| Dockets Entered
On May 19, 2004
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket
#
|
| Title
|
|
|
|
|
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
|
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
|
|
| 2002N-0534
|
| Medical Device User Fee and Modernization Act of 2002
|
|
|
|
|
| 2003D-0434
|
| Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications: Effect on FDA Review Clock and Performance Assessment; Availability
|
|
|
|
|
| 2004N-0115
|
| Prescription Drug Importation Study
|
|
|
|
|
| 2004N-0217
|
| Nutrient content claims: DHA, EPA, and ALA (Omega-3 Fatty Acids)
|
|
|
|
|
| 2004N-0230
|
| Food; Current Good Manufacturing Practice Regulations; Public Meetings
|
|
|
|
|
| 2004P-0236
|
| Revoke the Authority for Industry to Use Partially Hydrogenated Vegetable Oils in Foods
|
|
|
|
|
| 2004P-0239
|
| Issue a Final and Complete Guidance Document to Determine Bioequivalence (BE) for Nasal Spray Products.
|
|
|
|
|
| 2004S-0233
|
| Stimulating Innovation in Medical Technologies
|
|
|
|
|
| 2004V-0238
|
| Projector for a Laser Light Show
|
|
| |
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
|
|
|
|
| C
225
|
| BASF Corporation
|
| Vol #:
|
| 27
|
|
|
|
|
| C
226
|
| Keith's Variety Store
|
| Vol #:
|
| 27
|
|
|
|
|
| C
227
|
| Korean Embassy
|
| Vol #:
|
| 27
|
|
|
|
|
| C
228
|
| The Vinegar Institute
|
| Vol #:
|
| 27
|
|
|
|
|
| C
229
|
| American Free Trade Association
|
| Vol #:
|
| 27
|
|
|
|
|
| C
230
|
| Procter & Gamble Company
|
| Vol #:
|
| 27
|
|
|
|
|
| C
231
|
| Customs Brokers & International Freight Forwarders
|
| Vol #:
|
| 27
|
|
|
|
|
| C
232
|
| Diamond Walnut Growers
|
| Vol #:
|
| 27
|
|
|
|
|
| C
233
|
| American Council of Independent Laboratories (ACIL)
|
| Vol #:
|
| 27
|
|
|
|
|
| C
234
|
| Grocery Manufacturers of America (GMA)
|
| Vol #:
|
| 27
|
|
|
|
|
| C
235
|
| American Trucking Associations, Inc
|
| Vol #:
|
| 27
|
|
|
|
|
| C
236
|
| Canadian Embassy
|
| Vol #:
|
| 27
|
|
|
|
|
| C
237
|
| Ontario Ministry of Economic Development and Trade
|
| Vol #:
|
| 27
|
|
|
|
|
| C
238
|
| National Customs Brokers & Forwarders Association of America
|
| Vol #:
|
| 27
|
|
|
|
|
| C
239
|
| Canadian Produce Marketing Association
|
| Vol #:
|
| 27
|
|
|
|
|
| EC
357
|
| bi-pro Marketing Limited
|
| Vol #:
|
| 27
|
|
|
|
|
| EC
358
|
| TLR-Total Logistics Resource Inc.
|
| Vol #:
|
| 27
|
|
|
|
|
| EC
359
|
| Government of Argentina
|
| Vol #:
|
| 27
|
|
|
|
|
| EC
360
|
| Coppersmith Inc
|
| Vol #:
|
| 27
|
|
|
|
|
| EC
361
|
| Corn Products International, Inc.
|
| Vol #:
|
| 27
|
|
|
|
|
| EC
362
|
| BASF Corporation
|
| Vol #:
|
| 27
|
|
|
|
|
| EC
363
|
| Netherlands Min. of Ag., Nature and Food Quality
|
| Vol #:
|
| 27
|
|
|
|
|
| EC
364
|
| FedEx Trade Networks, Transport
|
| Vol #:
|
| 27
|
|
| | | | | | | | |
|
|
|
|
| EC 365
|
| British Embassy
|
| Vol #:
|
| 27
|
|
|
|
|
| EC 366
|
| Government of Japan
|
| Vol #:
|
| 27
|
|
|
|
|
| EC 367
|
| Baskets & Botanicals
|
| Vol #:
|
| 27
|
|
|
|
|
| EC 368
|
| AWBC
|
| Vol #:
|
| 27
|
|
|
|
|
| EC 369
|
| Ministry of Economy, Trade and Industry(METI)
|
| Vol #:
|
| 27
|
|
|
|
|
| EC 370
|
| European Commission Delegation
|
| Vol #:
|
| 27
|
|
|
|
|
| EC 371
|
| European Commission Delegation
|
| Vol #:
|
| 27
|
|
|
|
|
| EC 372
|
| COFEPRIS
|
| Vol #:
|
| 27
|
|
|
|
|
| EC 373
|
| Food Processors of Canada
|
| Vol #:
|
| 27
|
|
|
|
|
| EC 374
|
| Prince Edward Island Potato Board
|
| Vol #:
|
| 27
|
|
|
|
|
| EC 375
|
| International Bottled Water AAssociation
|
| Vol #:
|
| 27
|
|
|
|
|
| EC 376
|
| AAEI
|
| Vol #:
|
| 27
|
|
|
|
|
| EC 377
|
| Wild Bird Feeding Industry
|
| Vol #:
|
| 27
|
|
|
|
|
| EC 378
|
| Peruvian Commission for Export Promotion
|
| Vol #:
|
| 27
|
|
|
|
|
| EC 379
|
| Manitoba Agriculture, Food and Rural Initiatives
|
| Vol #:
|
| 27
|
|
|
|
|
| EC 380
|
| Manitoba Agriculture, Food and Rural Initiatives
|
| Vol #:
|
| 27
|
|
|
|
|
| EC 381
|
| Canadian Pork Council
|
| Vol #:
|
| 27
|
|
|
|
|
| EC 382
|
| FEPACH A.G.
|
| Vol #:
|
| 27
|
|
|
|
|
| EC 383
|
| National Food Processors Association
|
| Vol #:
|
| 27
|
|
|
|
|
| EC 384
|
| Peruvian Commission for Export Promotion
|
| Vol #:
|
| 27
|
|
|
|
|
| EMC
145
|
| National Coalition of Food Importing Associations
|
| Vol #:
|
| 27
|
|
|
|
|
| EMC
146
|
| Cheese Importers Association of America Inc
|
| Vol #:
|
| 27
|
|
|
|
|
| EMC
147
|
| Canadian Horticultural Council
|
| Vol #:
|
| 27
|
|
|
|
|
| EMC
148
|
| Fisheries Council of Canada
|
| Vol #:
|
| 27
|
|
|
|
|
| EMC
149
|
| FEPACH AG
|
| Vol #:
|
| 27
|
|
|
|
|
| EXT
1
|
| British Embassy
|
| Vol #:
|
| 27
|
|
|
|
|
| EXT
2
|
| The Scotch Whisky Association
|
| Vol #:
|
| 27
|
|
| |
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
|
|
| C
307
|
| The Vinegar Institute
|
| Vol #:
|
| 25
|
|
|
|
|
| C
308
|
| American Trucking Associations, Inc
|
| Vol #:
|
| 25
|
|
|
|
|
| C
309
|
| Customs Brokers & International Freight Forwarders
|
| Vol #:
|
| 25
|
|
|
|
|
| C
310
|
| Procter & Gamble Company
|
| Vol #:
|
| 25
|
|
|
|
|
| C
311
|
| Williams Clarke Company, Inc
|
| Vol #:
|
| 25
|
|
|
|
|
| C
312
|
| American Free Trade Association
|
| Vol #:
|
| 25
|
|
|
|
|
| C
313
|
| Continental Airlines
|
| Vol #:
|
| 25
|
|
|
|
|
| C
314
|
| Juice Products Association (JPA)
|
| Vol #:
|
| 25
|
|
| | | | | | | | |
|
|
|
|
| C
315
|
| FedEx Trade Networks Transport & Brokerage Inc (FTN)
|
| Vol #:
|
| 25
|
|
|
|
|
| C
316
|
| Northern Border Customs Brokers Association Inc
|
| Vol #:
|
| 25
|
|
|
|
|
| C
317
|
| BASF Corporation
|
| Vol #:
|
| 25
|
|
|
|
|
| C
318
|
| The Chicago Wine Company
|
| Vol #:
|
| 25
|
|
|
|
|
| C
319
|
| The Los ANgeles Customs Brokers & Freight Forwarders Association Inc
|
| Vol #:
|
| 25
|
|
|
|
|
| C
320
|
| American Council of Independent Laboratories (ACIL)
|
| Vol #:
|
| 25
|
|
|
|
|
| C
321
|
| Gloal Inflight Products
|
| Vol #:
|
| 25
|
|
|
|
|
| C
322
|
| Association of American Railroads
|
| Vol #:
|
| 25
|
|
|
|
|
| C
323
|
| National Association of Foreign-Trade Zones
|
| Vol #:
|
| 25
|
|
|
|
|
| C
324
|
| Maine Department of Transportation
|
| Vol #:
|
| 25
|
|
|
|
|
| C
325
|
| Canadian Embassy
|
| Vol #:
|
| 25
|
|
|
|
|
| C
326
|
| Canadian Embassy
|
| Vol #:
|
| 25
|
|
|
|
|
| C
327
|
| Camerican International, Inc
|
| Vol #:
|
| 25
|
|
|
|
|
| C
328
|
| International Activities Corporation
|
| Vol #:
|
| 25
|
|
|
|
|
| C
329
|
| Houston Customs Brokers and Freight Forwarders Association
|
| Vol #:
|
| 25
|
|
|
|
|
| C
330
|
| Fishking Processors, Inc
|
| Vol #:
|
| 25
|
|
|
|
|
| C
331
|
| Montreal, Maine & Atlantic Railway, Sunbury Transport Limited, New Brunswick, Southern Railway
|
| Vol #:
|
| 25
|
|
|
|
|
| C
332
|
| Sunbury Transport Limited et al
|
| Vol #:
|
| 25
|
|
|
|
|
| C
333
|
| National Customs Brokers and Forwarders Association of America
|
| Vol #:
|
| 25
|
|
|
|
|
| C
334
|
| Sigma-Aldrich Corporation
|
| Vol #:
|
| 25
|
|
|
|
|
| EMC
191
|
| Robin Hood Multifoods Corporation
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC
192
|
| Canadian Courier & Messenger Association
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC
193
|
| National Fisheries Institute
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC
194
|
| Health & Personal Care Logistics Conference Inc
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC
195
|
| Purcell International
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC
196
|
| Slade Gorton & Co
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC
197
|
| Canada Post Corporation
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC
198
|
| National Grain and Feed Association
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC
199
|
| Prior Notice Center Reviewer
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC
200
|
| Fisheries Council of Canada
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC
201
|
| FEPACH A.G.
|
| Vol #:
|
| 25
|
|
|
|
|
| NEC
2
|
| FDA
|
| Vol #:
|
| 22
|
|
|
|
|
| 2002N-0534
|
| Medical Device User Fee and Modernization Act of 2002
|
|
|
|
|
| LET
1
|
| Advanced Medical Technology Association
|
| Vol #:
|
| 2
|
|
|
|
|
| 2003D-0434
|
| Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications: Effect on FDA Review Clock and Performance Assessment; Availability
|
|
| | | | | | | | |
|
|
|
|
| C
1
|
| Advanced Medical Technology Association
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0115
|
| Prescription Drug Importation Study
|
|
|
|
|
| TS 44
|
| American Medical Association
|
| Vol #:
|
| 9
|
|
|
|
|
| TS 45
|
| Academy of Managed Care Pharmacy
|
| Vol #:
|
| 9
|
|
|
|
|
| TS 46
|
| American Pharmacists Association (APhA)
|
| Vol #:
|
| 9
|
|
|
|
|
| TS 47
|
| American Society of Health-System Pharmacist
|
| Vol #:
|
| 9
|
|
|
|
|
| TS 48
|
| European Association of Euro-Pharmaceutical Companies
|
| Vol #:
|
| 9
|
|
|
|
|
| TS 49
|
| MagenDavidMeds.com
|
| Vol #:
|
| 9
|
|
|
|
|
| TS 50
|
| National Association of Boards of Pharmacy
|
| Vol #:
|
| 9
|
|
|
|
|
| TS 51
|
| National Medical Association (NMA)
|
| Vol #:
|
| 9
|
|
|
|
|
| TS 52
|
| Ontario College of Pharmacists
|
| Vol #:
|
| 9
|
|
|
|
|
| TS 53
|
| American Academy of Physician Assistants
|
| Vol #:
|
| 9
|
|
|
|
|
| TS 54
|
| Alliance of Specialty Medicine
|
| Vol #:
|
| 9
|
|
|
|
|
| TS 55
|
| Canadian International Pharmacy Association (CIPA)
|
| Vol #:
|
| 9
|
|
|
|
|
| 2004N-0217
|
| Nutrient content claims: DHA, EPA, and ALA (Omega-3 Fatty Acids)
|
|
|
|
|
| ACK
1
|
| HFS-800 to Olsson, Frank and Weeda PC
|
| Vol #:
|
| 3
|
|
|
|
|
| CP
1
Tabs
1-7
|
| Alaska General Seafoods, Ocean Beauty Seafoods, Inc, Trans-Ocean Products, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| CR
1
|
| HFS-800 to Olsson, Frank and Weeda PC
|
| Vol #:
|
| 3
|
|
|
|
|
| LET
1
|
| HFS-200 to Institute of Medicine, National Academy of Science
|
| Vol #:
|
| 3
|
|
|
|
|
| 2004N-0230
|
| Food; Current Good Manufacturing Practice Regulations; Public Meetings
|
|
|
|
|
| NM
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0236
|
| Revoke the Authority for Industry to Use Partially Hydrogenated Vegetable Oils in Foods
|
|
|
|
|
| ACK
1
|
| HFA-305 to CSPI
|
| Vol #:
|
| 1
|
|
|
|
|
| C
1
|
| Harvard School of Public Health et al
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
|
| Center for Science in the Public Interest (CSPI)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0239
|
| Issue a Final and Complete Guidance Document to Determine Bioequivalence (BE) for Nasal Spray Products.
|
|
|
|
|
| ACK
1
|
| HFA-305
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
|
| GlaxoSmithKline (GSK)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004S-0233
|
| Stimulating Innovation in Medical Technologies
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004V-0238
|
| Projector for a Laser Light Show
|
|
|
|
|
| ACK
1
|
| HFA-305 to Excalibur Night Club
|
| Vol #:
|
| 1
|
|
