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| Dockets Entered
On May 11, 2004
Table of Contents
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| Docket #
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| Title
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| 1978N-0036L
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| OTC Laxative
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| 1994N-0164
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| Drug Export; Acticin
(Tretinoin 0.025% Gel USP)
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| 1998P-0151
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| Introduction Of Downed
Cattle Into The Food Supply
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| 1999F-4372
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| National Fisheries
Institute and the Louisiana Dep of Agricu
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| 1999F-5321
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| Food Safety &
Inspection service safe use of ionizing radiai
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| 1999F-5322
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| Ionizing Radiation
for the Treatment of Food
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| 1999F-5522
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| Ionizing radiation
/control of Food-borne pathogens safe use
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| 1999N-4282
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| Biotechnology in the
Year 2000 and Beyond; Public Meetings
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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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| 2000D-1350
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| Combined Oral Contraceptives/Labeling/Healthcare
Providers
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| 2000N-1571
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| Enrofloxacin for Poultry:
Opportunity for Hearing
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| 2001F-0047
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| Foodborne pathogens
in raw-frozen-cooked-partially cooked
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| 2001P-0075
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| Switch Status of Emergency
Contraceptives from Rx to OTC
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| 2001P-0230
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| Domestic Marketing
& Importation of Transgenic Fish
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| 2002N-0276
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| Bioterrorism Preparedness;
Registration of Food Facilities
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| 2002N-0278
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| Bioterrorism; Prior
Notice of Imported Food Shipments
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| 2003D-0493
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| Guidance on Powder
Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit
Sampling and Assessmen
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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-0274
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| In re Tier 1 initial
Approval Program
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| 2004D-0163
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| Guidance for Industry
and FDA Staff; Class II Special Controls Guidance Document: Immunomagnetic
Circulating Cancer Cell Selection and Enumeration System
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| 2004N-0133
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| Part 11, Electronic
Record; Electronic Signatures; Public Meeting
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| 2004P-0003
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| Petition to reconsider
the Food and Drug Administration's decision on the Med Watch complaint
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| 2004P-0126
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| Classification of
CellSearch Epithelial Cell Kit/Cell Spotter Analyzer
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| 2004P-0222
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| ANDA for a preserative-free
ciprofloxacin HCL (3.5 mg/mL equivalent to 3.0 mg/mL base) ophthalmic
solution in unit dose containers (04. mL)
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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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| 2004V-0224
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| Projector for a Laser
Light Show
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| 1978N-0036L
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| OTC Laxative
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| SUP
17
Tab A, B
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| C.B. Fleet Company,
Inc.
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| Vol #:
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| 138
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| 1994N-0164
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| Drug Export; Acticin
(Tretinoin 0.025% Gel USP)
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| BKG 1
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| Number not used
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| Vol #:
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| 2
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| 1998P-0151
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| Introduction Of
Downed Cattle Into The Food Supply
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| EMC 4226
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| D. Norwood
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| Vol #:
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| 304
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| EMC 4227
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| V. Horowitz
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| Vol #:
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| 304
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| | | | | | | | |
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| EMC 4228
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| T. Shirley
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| Vol #:
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| 304
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| EMC 4229
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| R. Gorham
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| Vol #:
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| 304
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| EMC 4230
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| T. Shirley
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| Vol #:
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| 304
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| EMC 4231
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| E. Moreno
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| Vol #:
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| 304
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| 1999F-4372
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| National Fisheries Institute and the Louisiana Dep of Agricu
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| EMC 473
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| L. Mroczek
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| Vol #:
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| 8
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| 1999F-5321
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| Food Safety & Inspection service safe use of ionizing radiai
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| EMC 376
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| L. Mroczek
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| Vol #:
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| 8
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| 1999F-5322
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| Ionizing Radiation for the Treatment of Food
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| EMC 375
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| L. Mroczek
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| Vol #:
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| 6
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| 1999F-5522
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| Ionizing radiation /control of Food-borne pathogens safe use
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| EMC 378
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| L. Mroczek
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| Vol #:
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| 6
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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|
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| EMC 4214
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| C. Guillermo
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| Vol #:
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| 515
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| EMC 4215
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| L. Rivera
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| Vol #:
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| 515
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|
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
|
|
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| EMC 532
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| No signature
|
| Vol #:
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| 24
|
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| EMC 533
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| K. Travis
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| Vol #:
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| 24
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| EMC 534
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| Rita
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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 783
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| Dr. T. Robison
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| Vol #:
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| 33
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| 2000D-1350
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| Combined Oral Contraceptives/Labeling/Healthcare Providers
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| C
20
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| Family Health Research
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| Vol #:
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| 6
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| C
21
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| American College of Obstetricians and Gynecologists (ACOG)
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| Vol #:
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| 6
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| C
22
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| National Assn of Nurse Practitioners in Women's Health (NPWH)
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| Vol #:
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| 6
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| C
23
Attachment 1,
2
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| Johnson and Johnson Pharmaceutical Research & Development, LLC
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| Vol #:
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| 6
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| EMC
2
Attachment
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| American College of Obstetricians and Gynecologists (ACOG)
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| Vol #:
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| 6
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| EMC
3
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| Planned PArenthood Federation of America, INc.
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| Vol #:
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| 6
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| EMC
4
Attachment 1, 2
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| Reproductive Health Technologies Project
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| Vol #:
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| 6
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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|
|
|
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| EMC 748
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| Judy Dement
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| Vol #:
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| 271
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|
| | | | | | | | |
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| EMC 6622
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| J. Kesich
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| Vol #:
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| 235
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|
|
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| EMC 6623
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| J.Kesich
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| Vol #:
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| 235
|
|
| |
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
|
|
|
|
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| EMC 3158
|
| M. Chambers
|
| Vol #:
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| 252
|
|
|
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| EMC 3159
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| M. Chambers
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| Vol #:
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| 252
|
|
|
|
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
|
|
|
|
|
| C
222
|
| Universal Postal Union
|
| Vol #:
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| 20
|
|
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| C
223
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| EWI, Inc.
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| Vol #:
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| 20
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| C
224
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| Airport Brokers Corporation
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| Vol #:
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| 20
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| EMC
143
Attachment
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| Universal Postal Union
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| Vol #:
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| 20
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| EMC
144
Attachment
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| Universal Postal Union
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| Vol #:
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| 20
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
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|
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| C
296
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| Fonterra (USA), Inc.
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| Vol #:
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| 22
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| C
297
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| National Soft Drink Assn (NSDA)
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| Vol #:
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| 22
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| EMC
167
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| Air Courier Conference of Maerica (ACCA)
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| Vol #:
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| 22
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|
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| 2003D-0493
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| Guidance on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessmen
|
|
|
|
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| EMC
11
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| Facility Automation Management Engineering Systems (FAME Systems)
|
| Vol #:
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| 2
|
|
|
|
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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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| EMC 179
|
| T. George
|
| Vol #:
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| 7
|
|
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| EMC 180
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| M. Sandli
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| Vol #:
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| 7
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| EMC 181
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| J. Luskin
|
| Vol #:
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| 7
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| EMC 182
|
| D. Nordquest
|
| Vol #:
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| 7
|
|
| |
|
| 2003N-0324
|
| New Animal Drugs; Removal of Obsolete and Redundant Regulations
|
|
|
|
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| EMC 1
|
| S. Justin
|
| Vol #:
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| 1
|
|
|
|
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| 2003P-0274
|
| In re Tier 1 initial Approval Program
|
|
|
|
|
| EMC
39
Attachment
|
| Abigail Alliance
|
| Vol #:
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| 4
|
|
|
|
|
| 2004D-0163
|
| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System
|
|
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
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| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0133
|
| Part 11, Electronic Record; Electronic Signatures; Public Meeting
|
|
|
|
|
| APE 3
|
| ABB Process Solutions
|
| Vol #:
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| 1
|
|
| | | | | | | | |
|
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| APE 4
|
| National Electrical Manufacturers Association (NEMA)
|
| Vol #:
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| 1
|
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| APE 5
|
| Johnson & Johnson
|
| Vol #:
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| 1
|
|
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| APE 6
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| National Food Processors Association
|
| Vol #:
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| 1
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|
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| APE 7
|
| KMI/Parexel LLC
|
| Vol #:
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| 1
|
|
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| APE 8
|
| Genentech Inc
|
| Vol #:
|
| 1
|
|
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| APE 9
|
| Dow Chemical Company
|
| Vol #:
|
| 1
|
|
|
|
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| APE 10
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| AdvaMed
|
| Vol #:
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| 1
|
|
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|
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| APE 11
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| Washington Safety Management Solutions, Cleveland Clinic Foundation
|
| Vol #:
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| 1
|
|
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| APE 12
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| F Hoffmann- La Roche AG
|
| Vol #:
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| 1
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| C
1
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| Family Health International
|
| Vol #:
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| 1
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|
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| EC 4
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| AstraZeneca
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| Vol #:
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| 1
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|
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| EMC
1
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| Mi Services Group
|
| Vol #:
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| 1
|
|
|
|
|
| 2004P-0003
|
| Petition to reconsider the Food and Drug Administration's decision on the Med Watch complaint
|
|
|
|
|
| CR 1
|
| Billy G. Pierson
|
| Vol #:
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| 1
|
|
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| LET 3
|
| Billy G. Pierson
|
| Vol #:
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| 1
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|
|
|
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| SUP 2
|
| Billy G. Pierson
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0126
|
| Classification of CellSearch Epithelial Cell Kit/Cell Spotter Analyzer
|
|
|
|
|
| NFR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0222
|
| ANDA for a preserative-free ciprofloxacin HCL (3.5 mg/mL equivalent to 3.0 mg/mL base) ophthalmic solution in unit dose containers (04. mL)
|
|
|
|
|
| ACK 1
|
| HFA-305 to Stradling Yocca Carlson and Rauth
|
| Vol #:
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| 1
|
|
|
|
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| CP
1
Tab 1, 2,
3
|
| Stradling Yocca Carlson and Rauth
|
| Vol #:
|
| 1
|
|
| |
|
| 2004S-0170
|
| Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
|
|
|
|
|
| EC
11
|
| Interamerican College of Physicians and Surgeons
|
| Vol #:
|
| 1
|
|
|
|
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| EC
12
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| California Neuroalliance
|
| Vol #:
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| 1
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|
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| EC
13
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| NAMI-Arkansas (National Alliance for the Mentally
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| Vol #:
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| 1
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|
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| EC
14
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| Oklahoma Mental Health Consumer Council
|
| Vol #:
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| 1
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|
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| EC
15
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| NAMI-Fort Smith
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| Vol #:
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| 1
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|
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| EC
16
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| Ms. Mary Worthen
|
| Vol #:
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| 1
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|
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| EC
17
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| National Latino Behavioral Health Association
|
| Vol #:
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| 1
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|
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| EC
18
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| National Silver Haired Congress
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| Vol #:
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| 1
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|
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| EC
19
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| Texas Renal Coalition
|
| Vol #:
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| 1
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|
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| EC
20
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| National Psoriasis Foundation
|
| Vol #:
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| 1
|
|
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|
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| EC
21
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| American Society of Health-System Pharmacists
|
| Vol #:
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| 1
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|
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|
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| EC
22
|
| Edmund S Muskie School of Public Service
|
| Vol #:
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| 1
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|
