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| Dockets Entered
On July 14, 2004
Table of Contents
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| Docket #
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| Title
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| 1995S-0316
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| 75-Day Premarket Notifications
for New Dietary Ingredients
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|
|
|
|
| 1999P-5106
|
| Identify Sources of
Natural Flavorings
|
|
|
|
|
| 2000D-1392
|
| Guidance for Industry on Botanical
Drug Products
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry:
Opportunity for Hearing
|
|
|
|
|
| 2001P-0075
|
| Switch Status of Emergency
Contraceptives from Rx to OTC
|
|
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior
Notice of Imported Food Shipments
|
|
|
|
|
| 2003D-0206
|
| Draft Guidance for Industry
on Exocrine Pancreatic Insufficiency Drug Products; Availability
|
|
|
|
|
| 2003D-0571
|
| Guidance for Industry
on Drug Substance; Chemistry, Manufacturing, and Controls Information
|
|
|
|
|
| 2003N-0233
|
| Over-the-Counter Drug
Products; Safety and Efficacy Review; Additional Sunscreen Ingredients
|
|
|
|
|
| 2003N-0324B
|
| Bacitracin methylene
disalicylate single-ingredient Type A Medicated articles
|
|
|
|
|
| 2003N-0324O
|
| Oxytetracycline and
neomycin fixed-combination Type A medicated articles
|
|
|
|
|
| 2003P-0029
|
| Remove metered-dose
inhalers (MDI) containing moiety albuter
|
|
|
|
|
| 2003Q-0401
|
| Qualified Health Claim
(QHC) Omega-3 Fatty Acids and Coronoary Heart Disease Health Claim
|
|
|
|
|
| 2004D-0189
|
| Guidance for Industry on Good
Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
|
|
|
| 2004D-0228
|
| Guidance for Industry
on Fixed Dose Combination and Co-Packaged Drug Products for Treatment
of HIV'
|
|
|
|
|
| 2004E-0302
|
| Patent Extenstion for
S8 Over-the Wire System ( Driver Stent Delivery System), U.S. Patent
No. 6,309,402
|
|
|
|
|
| 2004E-0303
|
| Patent Extension for
S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent
No. 5,879,382
|
|
|
|
|
| 2004E-0304
|
| Patent Extension for
S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent
No. 5,292,331
|
|
|
|
|
| 2004E-0306
|
| Patent Extension for
S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent
No. 5,836,965
|
|
|
|
|
| 2004N-0133
|
| Part 11, Electronic
Record; Electronic Signatures; Public Meeting
|
|
|
|
|
| 2004N-0205
|
| Furan in food; thermal treatment
|
|
|
| 2004P-0175
|
| ANADA for ageneric intravaginal
progesterone insert for cattle that differs from the pioneer product
(EAZI-BREED TM CIDR
|
|
|
|
|
| 2004P-0202
|
| Notify State & Federal
regulators of GRAS requirements of milk protein Concentrate
|
|
|
|
|
| 2004P-0237
|
| fundamental fairness
requires FDA to treat all news media,including the trade press,fairly
and equitably
|
|
|
|
|
| 2004Q-0201
|
| Qualified Health Claim
(QHC): Lycopene, Tomatoes and Various Cancers
|
|
|
|
|
| 2004V-0305
|
| Laser Light Show
|
|
|
|
|
| 1995S-0316
|
| 75-Day Premarket
Notifications for New Dietary Ingredients
|
|
|
|
|
| RPT
197
Attachments
|
| Cyber Store LLC
|
| Vol #:
|
| 145
|
|
|
|
|
| RPT
198
Attachments
|
| Kendy USA LLC
|
| Vol #:
|
| 145
|
|
|
|
|
| RPT
199
|
| Green Man International
Inc
|
| Vol #:
|
| 145
|
|
|
|
|
| RPT
200
Attachments
|
| Hormos Nutraceutical
Oy Ltd
|
| Vol #:
|
| 146
|
|
|
|
|
| 1999P-5106
|
| Identify Sources
of Natural Flavorings
|
|
|
|
|
| C 20
|
| L. Burleson
|
| Vol #:
|
| 2
|
|
|
|
|
| C 21
|
| C. Marchese
|
| Vol #:
|
| 2
|
|
|
|
|
| C 22
|
| G. Mack
|
| Vol #:
|
| 2
|
|
|
|
|
| C 23
|
| J. Capozzelli
|
| Vol #:
|
| 2
|
|
|
|
|
| 2000D-1392
|
| Guidance for Industry
on Botanical Drug Products
|
|
| | | | | | | | |
| |
|
|
| EC 1
|
| harvard,dartmouth,columbia
|
| Vol #:
|
| 1
|
| |
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
| |
|
|
| EXB 283
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 420
|
| |
|
|
| EXB 284
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 420
|
| |
|
|
| EXB 285
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 420
|
| |
|
|
| EXB 286
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 420
|
| |
|
|
| EXB 287
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 420
|
| |
|
|
| EXB 288
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 420
|
| |
|
|
| EXB 289
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 420
|
| |
|
|
| EXB 290
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 420
|
| |
|
|
| EXB 291
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 420
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| EC 806
|
| Ms. Kristin Bell
|
| Vol #:
|
| 163
|
| |
|
|
| EC 807
|
| Mr. Todd O'Buckley
|
| Vol #:
|
| 163
|
| |
|
|
| EC 808
|
| Mrs. Jennifer Gibbons
|
| Vol #:
|
| 163
|
| |
|
|
| EC 809
|
| Ms. Miranda Barbare
|
| Vol #:
|
| 163
|
| |
|
|
| EC 810
|
| University of New Mexico
|
| Vol #:
|
| 163
|
| |
|
|
| EMC 7532
|
| Dr. H. Lafone, O.D.
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7533
|
| D. Weish M.D.
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7534
|
| F. Long
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7535
|
| E. Rose RN
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7536
|
| J. Johnston
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7537
|
| J. Heichman
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7538
|
| S. R. Bagg
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7539
|
| I. Landsman
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7540
|
| L. Fiero-Carefoot
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7541
|
| E. G. Stevenson
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7542
|
| J. Dow
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7543
|
| E. Peterson
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7544
|
| M. Joyce
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7545
|
| A. Powel
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7546
|
| J. Huyler
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7547
|
| M. Kershaw
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7548
|
| E. Johnston
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7549
|
| A. Agigian
|
| Vol #:
|
| 280
|
|
| | | | | | | |
| |
|
|
| EMC 7550
|
| A. Tharp
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7551
|
| E. Carle
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7552
|
| A. Turner
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7553
|
| J. Boysko
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7554
|
| D. Merritt
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7555
|
| A. Wolfe
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7556
|
| M. Carle
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7557
|
| A. Eckley
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7558
|
| D. Barbee
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7559
|
| A. L. Hamblin
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7560
|
| C. Doolittle
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7561
|
| J. Konik
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7562
|
| B. Murray
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7563
|
| J. Curley
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7564
|
| J. L. Goldstein
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7565
|
| J. Hofmans
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7566
|
| C. Karpinski
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7567
|
| D. Pere
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7568
|
| E. Honey
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7569
|
| E. Smith
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7570
|
| Abbey
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7571
|
| C. Mott
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7572
|
| J. Cpeci
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7573
|
| D. M. Winer
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7574
|
| F. G. Curry
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7575
|
| J. Malyn
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7576
|
| S. Andre
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7577
|
| E. Heemskerk
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7578
|
| S. Andre
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7579
|
| J. G. Miller
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7580
|
| J. Boggs
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7581
|
| A. Friedman
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7582
|
| M. E. Reilly
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7583
|
| M. Schwartz
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7584
|
| J. L. Weitzel
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7585
|
| J Englander
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7586
|
| A. Bourek
|
| Vol #:
|
| 280
|
|
| | | | | | | | |
| |
|
|
| EMC 7587
|
| C. O'Bryan
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7588
|
| J .Conquest
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7589
|
| A Hansen
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7590
|
| J. lehr
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7591
|
| J. Crawford
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7592
|
| D. L. Beaupre
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7593
|
| Mrs. G. A. Alskog
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7594
|
| J. Luce
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7595
|
| Dr. K. Wilson
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7596
|
| B. Andrews
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7597
|
| J. A. Bowman-Kreitmeyer
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7598
|
| J. F. Kohler
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7599
|
| C. D. Martin
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7600
|
| D. Krasnoff
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7601
|
| C. Schitthenner
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7602
|
| B. Rodman
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7603
|
| J. McCulloch
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7604
|
| C. Lugo
|
| Vol #:
|
| 280
|
| |
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
| |
|
|
| C
353
|
| National Food Processors Assn (NFPA)
|
| Vol #:
|
| 29
|
| |
|
|
| C
354
|
| National Restaurant Association
|
| Vol #:
|
| 29
|
| |
|
|
| C
355
|
| Federal Express Corporation (FedEx)
|
| Vol #:
|
| 29
|
| |
|
|
| C
356
|
| Fine Wine Alliance
|
| Vol #:
|
| 29
|
| |
|
|
| C
357
|
| Sunbury Transport Limited et al.
|
| Vol #:
|
| 29
|
| |
|
|
| C
358
|
| Grocery Manufacturers of America (GMA)
|
| Vol #:
|
| 29
|
| |
|
|
| C
359
|
| Sigma-Aldrich Corporation
|
| Vol #:
|
| 29
|
| |
|
|
| C
360
|
| National Assn of Beverage Importers, Inc. et al
|
| Vol #:
|
| 29
|
| |
|
|
| C
361
|
| Government of Canada
|
| Vol #:
|
| 29
|
| |
|
|
| C
362
|
| Ontario Ministry of Economic Development and Trade (MEDT) and Ontario Ministry of Agriculture an
|
| Vol #:
|
| 30
|
| |
|
|
| CR
2
|
| National Food Processors Assn (NFPA)
|
| Vol #:
|
| 29
|
| |
|
|
| 2003D-0206
|
| Draft Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products; Availability
|
| |
|
|
| C
10
|
| Johnson & Johnson Pharmaceutical Research and Development, LLC
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0571
|
| Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
|
| |
|
|
| C
26
|
| Johnson and Johnson
|
| Vol #:
|
| 2
|
| |
|
|
| EC
7
|
| Merck KGaA
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| 2003N-0233
|
| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients
|
| |
|
|
| SUP 3
|
| Symrise Inc
|
| Vol #:
|
| 5
|
| |
|
|
| 2003N-0312
|
| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
|
| |
|
|
| EC 8
|
| Mr. Steve Kinney
|
| Vol #:
|
| 4
|
| |
|
|
| 2003N-0324B
|
| Bacitracin methylene disalicylate single-ingredient Type A Medicated articles
|
| |
|
|
| LET
4
|
| HF-1
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0324O
|
| Oxytetracycline and neomycin fixed-combination Type A medicated articles
|
| |
|
|
| LET
4
|
| HF-1
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0029
|
| Remove metered-dose inhalers (MDI) containing moiety albuter
|
| |
|
|
| C
19
|
| K. Rix, PharmD
|
| Vol #:
|
| 2
|
| |
|
|
| 2003Q-0401
|
| Qualified Health Claim (QHC) Omega-3 Fatty Acids and Coronoary Heart Disease Health Claim
|
| |
|
|
| LET
7
|
| Martek Biosciences Corporation
|
| Vol #:
|
| 2
|
| |
|
|
| LET
8
|
| American Longevity Inc and Life Extension Foundation Buyers Club Inc
|
| Vol #:
|
| 2
|
| |
|
|
| 2004D-0160
|
| Use of Unapproved Hormone Implants in Veal Calves
|
| |
|
|
| EC 1
|
| Mr. Frank DiCostanzo
|
| Vol #:
|
| 1
|
| |
|
|
| 2004D-0189
|
| Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
|
| |
|
|
| EC
1
Attachment
|
| The Brighton Collaboration
|
| Vol #:
|
| 1
|
| |
|
|
| EC
2
|
| Eli Lilly and Company
|
| Vol #:
|
| 1
|
| |
|
|
| 2004D-0228
|
| Guidance for Industry on Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV'
|
| |
|
|
| C
1
|
| GlaxoSmithKline (GSK)
|
| Vol #:
|
| 1
|
| |
|
|
| C
2
|
| Elizabeth Glaser Pediatric AIDS Foundation
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0302
|
| Patent Extenstion for S8 Over-the Wire System ( Driver Stent Delivery System), U.S. Patent No. 6,309,402
|
| |
|
|
| APP
1
Exhibit A, B,
C, D
|
| Medtronic Vascular
|
| Vol #:
|
| 1
|
| |
|
|
| LET
1
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| LET
2
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0303
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,879,382
|
| |
|
|
| APP
1
|
| Medtronic Vascular
|
| Vol #:
|
| 1
|
| |
|
|
| LET
1
|
| U.S Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| LET
2
|
| U.S Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0304
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,292,331
|
|
| | | | | | | | |
| |
|
|
| APP
1
|
| Medtronic Vascular
|
| Vol #:
|
| 1
|
| |
|
|
| LET
1
|
| U.S Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| LET
2
|
| U.S Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0306
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,836,965
|
| |
|
|
| APP
1
|
| Medtronic Vascular
|
| Vol #:
|
| 1
|
| |
|
|
| LET
1
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| LET
2
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0133
|
| Part 11, Electronic Record; Electronic Signatures; Public Meeting
|
| |
|
|
| C
34
|
| National Food Processors Assn (NFPA)
|
| Vol #:
|
| 5
|
| |
|
|
| 2004N-0205
|
| Furan in food; thermal treatment
|
| |
|
|
| EC
2
Attachment
|
| Swiss Federal Office of Public Health
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0242
|
| Institutional Review Boards; Registration Requirements
|
| |
|
|
| EC 1
|
| Mrs. Beverly Brown
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0175
|
| ANADA for ageneric intravaginal progesterone insert for cattle that differs from the pioneer product (EAZI-BREED TM CIDR
|
|
|
| C
2
|
| InterAg Controlled Breeding Technologies
|
| Vol #:
|
| 1
|
| |
|
|
| RC
1
|
| Intervet Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0202
|
| Notify State & Federal regulators of GRAS requirements of milk protein Concentrate
|
| |
|
|
| C 8
|
| J. Amory
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0237
|
| fundamental fairness requires FDA to treat all news media,including the trade press,fairly and equitably
|
| |
|
|
| C
1
|
| Washington Business Information, Inc. (WBII)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004Q-0201
|
| Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
|
| |
|
|
| C
1
Attachments
|
| Campbell Soup Company
|
| Vol #:
|
| 16
|
| |
|
|
| EC 1
|
| Mr. G MK
|
| Vol #:
|
| 16
|
| |
|
|
| EC 2
|
| Ms. G MK
|
| Vol #:
|
| 16
|
| |
|
|
| 2004V-0305
|
| Laser Light Show
|
| |
|
|
| ACK 1
|
| HFA-305 to Oddyssey Enterprises
|
| Vol #:
|
| 1
|
| |
|
|
| VAR
1
|
| Oddyssey Enterprises
|
| Vol #:
|
| 1
|
|
|
