| | | | | | | | | | |
|
|
| Dockets Entered
On May 18, 2004
Table of Contents
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
| 2003D-0319
|
| Guidance for Industry and FDA Staff; Draft; Premarket Assessment of Pediatric Medical Devices
|
|
|
| 2003N-0528
|
| Revision of the Requirements for Spore-Forming Microorganisms
|
|
|
| 2004N-0115
|
| Prescription Drug Importation Study
|
|
|
| 2004P-0235
|
| Request Addition of Postmarketing Suicide Reports to the Neurontin Labeling
|
|
|
| 2004P-0237
|
| fundamental fairness requires FDA to treat all news media,including the trade press,fairly and equitably
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
| EXC 2
|
| Bayer Corporation & Animal Health Institute
|
| Vol #:
|
| 445
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
| C
298
|
| Cheese Importers Association of America Inc
|
| Vol #:
|
| 23
|
|
|
| C
299
|
| CSPI, Center for Science in the Public Interest
|
| Vol #:
|
| 24
|
|
|
| C
300
|
| Mid-American Overseas, Inc
|
| Vol #:
|
| 24
|
|
|
| C
301
|
| International In Flight Food Service Association
|
| Vol #:
|
| 24
|
|
|
| C
302
|
| Flegenheimer International Inc
|
| Vol #:
|
| 24
|
|
|
| C
303
|
| Korean Embassy
|
| Vol #:
|
| 24
|
|
|
| C
304
|
| Reunioin Island Coffee
|
| Vol #:
|
| 24
|
|
|
| C
305
|
| United States Postal Service
|
| Vol #:
|
| 24
|
|
|
| C
306
|
| Milky Way International Trading Corp.
|
| Vol #:
|
| 24
|
|
|
| EMC
168
|
| AFMC (Agricultural and Fishery Marketing Corporation)
|
| Vol #:
|
| 23
|
|
|
| EMC
169
|
| Two Hills Tea
|
| Vol #:
|
| 23
|
|
|
| EMC
170
|
| Kinnikinnick Foods Inc
|
| Vol #:
|
| 23
|
|
|
| EMC
171
|
| National Coalition of Food Importion Associations
|
| Vol #:
|
| 23
|
|
|
| EMC
172
|
| National Coalition of Food Importion Associations
|
| Vol #:
|
| 23
|
|
|
| EMC
173
|
| TPG Post
|
| Vol #:
|
| 23
|
|
|
| EMC
174
|
| Cheese Importers Association of America, Inc
|
| Vol #:
|
| 23
|
|
|
| EMC
175
|
| Calloway Corporation Airline Catering Service
|
| Vol #:
|
| 24
|
|
|
| EMC
176
|
| Posten Sverige AB
|
| Vol #:
|
| 24
|
|
|
| EMC
177
|
| Belgian post International
|
| Vol #:
|
| 24
|
|
|
| EMC
178
|
| Royal TPG Post BV
|
| Vol #:
|
| 24
|
|
|
| EMC
179
|
| Sinco Inc
|
| Vol #:
|
| 24
|
|
|
| EMC
180
|
| AMD Oil Sales LLC
|
| Vol #:
|
| 24
|
|
|
| EMC
181
|
| Abby Foods LLC
|
| Vol #:
|
| 24
|
|
|
| EMC
182
|
| Purcell International
|
| Vol #:
|
| 24
|
|
|
| EMC
183
|
| Purcell International
|
| Vol #:
|
| 24
|
|
| | | | | | | | |
|
|
| EMC
184
|
| Correos y Telegrafos
|
| Vol #:
|
| 24
|
|
|
| EMC
185
|
| Poste Italiane
|
| Vol #:
|
| 24
|
|
|
| EMC
186
|
| Deutsche Post World Net
|
| Vol #:
|
| 24
|
|
|
| EMC
187
|
| FedEx
|
| Vol #:
|
| 24
|
|
|
| EMC
188
|
| FedEx Federal Express Corporation
|
| Vol #:
|
| 24
|
|
|
| EMC
189
|
| German Agricultural Marketing Board
|
| Vol #:
|
| 24
|
|
|
| EMC
190
|
| Canadian Horticultural Council
|
| Vol #:
|
| 24
|
|
|
| 2003D-0319
|
| Guidance for Industry and FDA Staff; Draft; Premarket Assessment of Pediatric Medical Devices
|
|
|
| GDL
2
|
| GUIDANCE
|
| Vol #:
|
| 1
|
|
|
| NAD
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003N-0528
|
| Revision of the Requirements for Spore-Forming Microorganisms
|
|
|
| NCR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0115
|
| Prescription Drug Importation Study
|
|
|
| C 7
|
| American Tort Reform Association (ATRA)
|
| Vol #:
|
| 9
|
|
|
| EC
33
|
| METROPOLITAN ANESTHESIA NETWORK, LLP
|
| Vol #:
|
| 9
|
|
|
| EC
34
|
| Canadian Pharmacists Association
|
| Vol #:
|
| 9
|
|
|
| EC
35
|
| Citizens Against Lawsuit Abuse
|
| Vol #:
|
| 9
|
|
|
| EC
36
|
| Mr. Jay Starkman
|
| Vol #:
|
| 9
|
|
|
| EC
37
|
| American Public Health Association
|
| Vol #:
|
| 9
|
|
|
| EC
38
|
| Mr. Guy Jordan
|
| Vol #:
|
| 9
|
|
|
| EC
39
|
| Mr. Bob DiPaolo
|
| Vol #:
|
| 9
|
|
|
| EC
40
|
| Dr. Alina Urriola
|
| Vol #:
|
| 9
|
|
|
| EC
41
|
| Alzheimer's Aid Society
|
| Vol #:
|
| 9
|
|
|
| EC
42
|
| National Association of Cancer Patients
|
| Vol #:
|
| 9
|
|
|
| EMC
12
Attachment
|
| Mathew B.R. Nessetti, Ph.D., M.P.
|
| Vol #:
|
| 9
|
|
|
| EMC
13
Attachment
|
| Pharmaceutical Research and Manufacturers of America (PhRMA)
|
| Vol #:
|
| 9
|
|
|
| EMC
14
|
| Canadian Pharmacists Association
|
| Vol #:
|
| 9
|
|
|
| 2004P-0235
|
| Request Addition of Postmarketing Suicide Reports to the Neurontin Labeling
|
|
|
| ACK 1
|
| HFA-305 to Finkelstein and Partners
|
| Vol #:
|
| 1
|
|
|
| CP
1
|
| Finkelstein and Partners
|
| Vol #:
|
| 1
|
|
|
| 2004P-0237
|
| fundamental fairness requires FDA to treat all news media,including the trade press,fairly and equitably
|
|
|
| ACK 1
|
| HFA-305 to FERDIC, Incorporated
|
| Vol #:
|
| 1
|
|
|
| CP
1
|
| FERDIC, Incorporated
|
| Vol #:
|
| 1
|
|