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| Dockets Entered
On November 12, 2003
Table of Contents
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| Docket #
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| Title
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| 1977N-0094
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| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
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| 1981N-0033P
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| Antiplaque & Antiplaque-Related Claims
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| 1983V-0151
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| LASER LIGHT SHOW
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|
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| 1996N-0417
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| CGMP in Mfg. Packing or Holding Dietary Supplements
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|
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
|
|
|
| 1999P-1658
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| Codify Existing Practice to determine Active Ingredients
|
|
|
| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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|
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| 2000P-1275
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| Health Claim: Vegetable oil sterol esters & coronary heart d
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|
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| 2000P-1276
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| Health Claim: Plant stanol esters and heart disease
|
|
|
| 2001P-0573
|
| Petition for Regulation of S & F Nicotine Water
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|
|
| 2002E-0099
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| Patent Term Extension Application for XIGRIS No. 4,775,624
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|
|
| 2002E-0184
|
| Patent Extension Application for XIGRIS, No. 5,681,932
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|
|
| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
|
|
|
| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| 2002P-0067
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| All estrogen-containing products intended for oral use
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|
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| 2002P-0431
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| Delcobese Tablets and Capsules
|
|
|
| 2002P-0506
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| Was Wydase (Hyaluronidase) Inj. withdrawn for Safety Reasons
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| 2003D-0382
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| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
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| 2003D-0383
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| Draft Guidance for Industry and FDA Staff; Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Availability
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|
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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|
|
| 2003D-0498
|
| Compliance Program Guidance Manual 7371.009; BSE/Ruminant Feed Ban Inspections; Availability
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|
|
| 2003E-0150
|
| Patent extension ABILIFY (aripiprazole) Patent No. 5,006,528
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|
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| 2003E-0153
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| Patent Extension #5,420,319 for Eloxatin (oxaliplatin)
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| 2003E-0246
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| Patent Extension for Deramaxx (deracoxib), 5,521,207,
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|
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| 2003E-0250
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| Patent Extension for Invanz (ertapenem sodium), 5,478,820
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|
| 2003E-0253
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| Patent Extension for Lexapro (escitalopram oxalate), 34,712
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|
|
| 2003E-0255
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| Patent Extension for Xigris (drotrecogin alpha), 4,775,624 and 5,009,889, and 5,681,932
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|
|
| 2003E-0261
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| Patent Extension for Strattera (atomoxetine hydrochloride), 5,658,590
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|
|
| 2003N-0211
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| Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma
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|
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2003N-0361
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| Anti-Counterfeit Drug Initiative
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|
|
| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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|
|
| 2003N-0506
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| Agency Emergency Processing Request Under OMB Review; Experimental Study of Possible Footnotes and Cuing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition Facts Pa
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| 2003N-0507
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| Agency Emergency Processing Request Under OMB Review; Experimental Study of Trans Fat Claims on Foods
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| 2003P-0021
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| Withdrawal of Wydase, Hyaluronidase Injection
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| 2003P-0078
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| Public Health Security & Bioterrorism Preparedness & Respons
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| | | | | | | | |
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| 2003P-0274
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| In re Tier 1 initial Approval Program
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| 2003P-0461
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| Abbreviation New Drug Application (ANDA) suitablility for 7.5 mg of Cyclobenzaprine HCI
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| 2003P-0523
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| ANADA Suitability Petition for Ivermectin/Praziquantel Granule/Crumble Anthelmintic for Horses
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|
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| 2003V-0131
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| Laser Light Show
|
|
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| 1977N-0094
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| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
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|
|
| M 10
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| HFD-560 Annoucement of 11/19/2003 Meeting w/Bayer Healthcare LLC
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| Vol #:
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| 235
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|
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| 1981N-0033P
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| Antiplaque & Antiplaque-Related Claims
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|
|
| SUP 2
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| Janet M. Wehrli, RDH
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| Vol #:
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| 1
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|
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| 1983V-0151
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| LASER LIGHT SHOW
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|
|
| VRA
10
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| HFZ-300 to Precision Projection Systems, Inc.
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| Vol #:
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| 1
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|
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| 1996N-0417
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| CGMP in Mfg. Packing or Holding Dietary Supplements
|
|
|
| REF
1
Part
A1, A2, A3,
A4, A5,
A6, B1,
B2, C
|
| OMB Review held on March 13, 2003
|
| Vol #:
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| 42
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|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
| C 7245
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| Jeane M. Palmer
|
| Vol #:
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| 303
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|
|
| C 7246
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| J.P. Aarnow
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| Vol #:
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| 303
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|
|
| C 7247
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| Michele R. Waddill
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| Vol #:
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| 303
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|
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| C 7248
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| Karon Mariani
|
| Vol #:
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| 303
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|
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| C 7249
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| Mary Fox
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| Vol #:
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| 303
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|
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| C 7250
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| T. Kelly Mason
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| Vol #:
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| 303
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|
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| C 7251
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| Mary Pinto
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| Vol #:
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| 303
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|
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| C 7252
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| Stephanie M. Williams
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| Vol #:
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| 303
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| C 7253
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| Gabriele Timmusman
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| Vol #:
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| 303
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| C 7254
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| Patricia K. Luxford
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| Vol #:
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| 303
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| C 7255
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| Sally & Dick Blinke
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| Vol #:
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| 303
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| C 7256
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| Linda WIlliams
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| Vol #:
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| 303
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|
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| C 7257
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| Eligible
|
| Vol #:
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| 303
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|
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| C 7258
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| Nancy S. Kilgore
|
| Vol #:
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| 303
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|
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| C 7259
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| Christa Viola
|
| Vol #:
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| 303
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|
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| C 7260
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| Jo Noble
|
| Vol #:
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| 303
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|
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| C 7261
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| Nicole Brunt
|
| Vol #:
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| 303
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|
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| C 7262
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| Jean Palmer
|
| Vol #:
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| 303
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|
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| C 7263
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| Michele Madaski
|
| Vol #:
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| 303
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|
| | | | | | | | |
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| EMC 3950
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| Andrea Knepper
|
| Vol #:
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| 304
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|
|
| EMC 3951
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| Crystal Ringkvist-Helsel
|
| Vol #:
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| 304
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|
|
| EMC 3952
|
| Tanja Froehlich
|
| Vol #:
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| 304
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|
|
| EMC 3953
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| Beverly Siegel
|
| Vol #:
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| 304
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|
|
| EMC 3954
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| Ellen Tchartorisky
|
| Vol #:
|
| 304
|
|
|
| EMC 3955
|
| Kimberly A. Hutchins
|
| Vol #:
|
| 304
|
|
|
| EMC 3956
|
| Amos El-Roy
|
| Vol #:
|
| 304
|
|
|
| EMC 3957
|
| Jayne Cotten
|
| Vol #:
|
| 304
|
|
|
| EMC 3958
|
| Jennifer Marione
|
| Vol #:
|
| 304
|
|
|
| EMC 3959
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| Meredith Johnston
|
| Vol #:
|
| 304
|
|
|
| EMC 3960
|
| Tiffiney Sparhawk
|
| Vol #:
|
| 304
|
|
|
| EMC 3961
|
| Brian Smith
|
| Vol #:
|
| 304
|
|
|
| EMC 3962
|
| Pinky Jain Pan
|
| Vol #:
|
| 304
|
|
|
| EMC 3963
|
| Karen-Jean Grant
|
| Vol #:
|
| 304
|
|
|
| EMC 3964
|
| Dale Masters
|
| Vol #:
|
| 304
|
|
|
| EMC 3965
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| Jennifer Browning
|
| Vol #:
|
| 304
|
|
|
| EMC 3966
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| Dia Redman
|
| Vol #:
|
| 304
|
|
|
| EMC 3967
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| Amy Liberatore
|
| Vol #:
|
| 304
|
|
|
| EMC 3968
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| Brian Kestner
|
| Vol #:
|
| 304
|
|
|
| EMC 3969
|
| Donna Hammett
|
| Vol #:
|
| 304
|
|
|
| 1999P-1658
|
| Codify Existing Practice to determine Active Ingredients
|
|
|
| WDL
1
|
| Generic Pharmaceutical Assn (GPhA)
|
| Vol #:
|
| 1
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
| M
4
|
| GCF-1
|
| Vol #:
|
| 389
|
|
|
| 2000P-1275
|
| Health Claim: Vegetable oil sterol esters & coronary heart d
|
|
|
| MM
2
|
| Meeting on Smart Balance and Coronary Heart Disease
|
| Vol #:
|
| 22
|
|
|
| 2000P-1276
|
| Health Claim: Plant stanol esters and heart disease
|
|
|
| MM
6
|
| Meeting on Smart Balance and Coronary Heart Disease
|
| Vol #:
|
| 22
|
|
|
| 2001P-0573
|
| Petition for Regulation of S & F Nicotine Water
|
|
|
| C
3
Tab
A-G
|
| GlaxoSmithKline Consumer Healthcare, LP (GSK)
|
| Vol #:
|
| 1
|
|
|
| 2002E-0099
|
| Patent Term Extension Application for XIGRIS No. 4,775,624
|
|
|
| LET
3
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2002E-0184
|
| Patent Extension Application for XIGRIS, No. 5,681,932
|
|
| | | | | | | | |
|
|
| LET
2
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
|
|
| C
165
|
| Government of the Honh Kong Special Administrative Region
|
| Vol #:
|
| 15
|
|
|
| EMC
101
|
| Peter Hodge Transport
|
| Vol #:
|
| 15
|
|
|
| EMC
102
|
| The Landfall Centre
|
| Vol #:
|
| 15
|
|
|
| EMC
103
|
| The Landfall Centre
|
| Vol #:
|
| 15
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
| C
233
|
| Government of the Honh Kong Special Administrative Region
|
| Vol #:
|
| 17
|
|
|
| C
234
|
| The Chicago Wine Company
|
| Vol #:
|
| 17
|
|
|
| EMC
123
|
| The Landfall Centre
|
| Vol #:
|
| 17
|
|
|
| EMC
124
|
| The Landfall Centre
|
| Vol #:
|
| 17
|
|
|
| 2002P-0067
|
| All estrogen-containing products intended for oral use
|
|
|
| PDN
1
|
| HFD-001 to Physicians Committee for Responsible Medicine
|
| Vol #:
|
| 1
|
|
|
| 2002P-0431
|
| Delcobese Tablets and Capsules
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2002P-0506
|
| Was Wydase (Hyaluronidase) Inj. withdrawn for Safety Reasons
|
|
|
| LET
2
|
| HFD-007 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2003D-0382
|
| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
|
|
|
| C
30
|
| Allergan, Inc.
|
| Vol #:
|
| 3
|
|
|
| C
31
|
| Pharmaceutical Research and Manufacturers of America (PhRMA)
|
| Vol #:
|
| 3
|
|
|
| 2003D-0383
|
| Draft Guidance for Industry and FDA Staff; Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Availability
|
|
|
| C
1
|
| Promega, Corporation
|
| Vol #:
|
| 1
|
|
|
| 2003D-0478
|
| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
|
|
|
| C 1
|
| Hilda Horvat
|
| Vol #:
|
| 1
|
|
|
| C 2
|
| Rosalie Zwain
|
| Vol #:
|
| 1
|
|
|
| 2003D-0498
|
| Compliance Program Guidance Manual 7371.009; BSE/Ruminant Feed Ban Inspections; Availability
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003E-0150
|
| Patent extension ABILIFY (aripiprazole) Patent No. 5,006,528
|
|
|
| LET
3
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| 2003E-0153
|
| Patent Extension #5,420,319 for Eloxatin (oxaliplatin)
|
|
|
| LET
3
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0246
|
| Patent Extension for Deramaxx (deracoxib), 5,521,207,
|
|
|
| LET
3
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0250
|
| Patent Extension for Invanz (ertapenem sodium), 5,478,820
|
|
|
| LET
3
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0253
|
| Patent Extension for Lexapro (escitalopram oxalate), 34,712
|
|
|
| LET
3
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0255
|
| Patent Extension for Xigris (drotrecogin alpha), 4,775,624 and 5,009,889, and 5,681,932
|
|
|
| LET
2
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0261
|
| Patent Extension for Strattera (atomoxetine hydrochloride), 5,658,590
|
|
|
| LET
4
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003N-0211
|
| Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma
|
|
|
| C
11
|
| Canadian Blood Services (CBS)
|
| Vol #:
|
| 1
|
|
|
| C
12
|
| University of California, Davis
|
| Vol #:
|
| 1
|
|
|
| 2003N-0312
|
| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
|
|
|
| C
5
|
| National Grain and Feed Assn (NGFA)
|
| Vol #:
|
| 1
|
|
|
| LST
1
|
| List of Attendees at the Animal Feed Safety System Public Meeting held 9/23-24/2003
|
| Vol #:
|
| 1
|
|
|
| LST
2
|
| Agenda for Animal Feed Safety System (AFFSS) public meeting held on 9/23-24/2003
|
| Vol #:
|
| 1
|
|
|
| LST
3
|
| List of AFSS Team and Participates
|
| Vol #:
|
| 1
|
|
|
| SUP 1
|
| Breakout Group 1A
|
| Vol #:
|
| 1
|
|
|
| SUP 2
|
| Breakout Group 1B
|
| Vol #:
|
| 1
|
|
|
| SUP 3
|
| Breakout Group 2A
|
| Vol #:
|
| 1
|
|
|
| SUP 4
|
| Breakout Group 2B
|
| Vol #:
|
| 1
|
|
|
| SUP 5
|
| Breakout Group 3A
|
| Vol #:
|
| 1
|
|
|
| SUP 6
|
| Breakout Group 3B
|
| Vol #:
|
| 1
|
|
|
| SUP 7
|
| Breakout Group 4A
|
| Vol #:
|
| 1
|
|
|
| SUP 8
|
| Breakout Group 4B
|
| Vol #:
|
| 1
|
|
|
| SUP 9
|
| Breakout Group 5A
|
| Vol #:
|
| 1
|
|
|
| SUP 10
|
| Breakout Group 5B
|
| Vol #:
|
| 1
|
|
|
| SUP 11
|
| Breakout Group 6A
|
| Vol #:
|
| 1
|
|
|
| SUP 12
|
| Breakout Group 6B
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| TR
1
|
| Animal Feed Safety System Public Meeting held 9/23/2003
|
| Vol #:
|
| 2
|
|
|
| TR
2
|
| Animal Feed Safety System Public Meeting held 9/24/2003
|
| Vol #:
|
| 3
|
|
|
| TS
1
|
| Prince Agri Products, Inc.
|
| Vol #:
|
| 1
|
|
|
| TS
2
|
| Taylor Packing Co.
|
| Vol #:
|
| 1
|
|
|
| TS 3
|
| Wenger Feeds
|
| Vol #:
|
| 1
|
|
|
| TS 4
|
| Dcane Pet Food
|
| Vol #:
|
| 1
|
|
|
| TS 5
|
| California Department of Food & Agriculture
|
| Vol #:
|
| 1
|
|
|
| TS
6
|
| Herr Angus Farm
|
| Vol #:
|
| 1
|
|
|
| TS 7
|
| Food Animal Concerns Trust
|
| Vol #:
|
| 1
|
|
|
| 2003N-0361
|
| Anti-Counterfeit Drug Initiative
|
|
|
| C
37
Enclosure
|
| Watson Label Products
|
| Vol #:
|
| 5
|
|
|
| C
38
|
| Pharmaceutical Research and Manufacturers of America (PhRMA)
|
| Vol #:
|
| 5
|
|
|
| C
39
|
| NorthAmerican-Pharmotherapeutic Consultants Assn (NorthAmerican - PCA)
|
| Vol #:
|
| 5
|
|
|
| TR
1
Part 2,
3, 4
|
| Anti-Counterfeit Drug Initiative Public Meeting held 10/15/2003
|
| Vol #:
|
| 6
|
|
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
|
|
| C 1
|
| Maureen McDonald
|
| Vol #:
|
| 1
|
|
|
| C 2
|
| Matthew Kohut
|
| Vol #:
|
| 1
|
|
|
| C 3
|
| Allison J. Maffucci
|
| Vol #:
|
| 1
|
|
|
| REF
1
Tab A,
B, C
|
| OMB Review for Control of Cummunicable Diseases;Restrictions on African Rodents, Prairie Dogs
|
| Vol #:
|
| 1
|
|
|
| 2003N-0506
|
| Agency Emergency Processing Request Under OMB Review; Experimental Study of Possible Footnotes and Cuing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition Facts Pa
|
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003N-0507
|
| Agency Emergency Processing Request Under OMB Review; Experimental Study of Trans Fat Claims on Foods
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003P-0021
|
| Withdrawal of Wydase, Hyaluronidase Injection
|
|
|
| LET
2
|
| HFD-007 to Amphastar Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2003P-0078
|
| Public Health Security & Bioterrorism Preparedness & Respons
|
|
|
| LET
1
|
| HF-22 to Olsson, Frank and Weeda, PC
|
| Vol #:
|
| 1
|
|
|
| 2003P-0270
|
| Prohibit False and Misleading Labeling
|
|
|
| C 37
|
| Marian Orvis
|
| Vol #:
|
| 6
|
|
|
| C 38
|
| Dianne Bahr
|
| Vol #:
|
| 6
|
|
|
| 2003P-0274
|
| In re Tier 1 initial Approval Program
|
|
| | | | | | | | |
|
|
| C 2
|
| Gene E. Krueger
|
| Vol #:
|
| 1
|
|
|
| C 3
|
| Patricia Harper Haas
|
| Vol #:
|
| 1
|
|
|
| C 4
|
| Susan M. Hurdle
|
| Vol #:
|
| 1
|
|
|
| C 5
|
| Michael Post
|
| Vol #:
|
| 1
|
|
|
| C
6
|
| Aids Treatment Activist Coalition (ATAC)
|
| Vol #:
|
| 1
|
|
|
| C 7
|
| Cindy Shaw
|
| Vol #:
|
| 1
|
|
|
| C 8
|
| Robert L. Stewart
|
| Vol #:
|
| 1
|
|
|
| 2003P-0461
|
| Abbreviation New Drug Application (ANDA) suitablility for 7.5 mg of Cyclobenzaprine HCI
|
|
|
| C
1
|
| McNeil Consumer & Speciality Phamaceuticals (McNeil)
|
| Vol #:
|
| 1
|
|
|
| 2003P-0523
|
| ANADA Suitability Petition for Ivermectin/Praziquantel Granule/Crumble Anthelmintic for Horses
|
|
|
| ACK 1
|
| HFA-305 to Karen A. Sisson
|
| Vol #:
|
| 1
|
|
|
| CP
1
Enclosure
|
| Karen A. Sisson
|
| Vol #:
|
| 1
|
|
|
| 2003V-0131
|
| Laser Light Show
|
|
|
| VRA
2
|
| HFZ-300 to Laser Design Productions, Inc.
|
| Vol #:
|
| 1
|
|
|