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| Dockets Entered
On November 3, 2003
Table of Contents
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| Docket #
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| Title
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| 1994D-0025
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| Interim GDL/Labeling Milk & Milk Products from Cows w/rbST
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| 1994V-0416
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| Laser Light Show
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| 1997P-0329
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| Require Quantitative Labeling of Caffeine Content
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| 1998D-0896
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| Medical Device Industry PMA shell development/modular review
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| 1998P-0035
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| Exemption 21 CFR821 (b) Medical Device Tracking Requirements
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1998V-0817
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| Variance for emission delay for BioFlex Professional Laser
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| 2000N-1484
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| Safety Reporting Requirements Human Drug/Biological Products
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| 2000P-1322
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| Food Labeling and Allergen Contamination Control
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| 2002P-0294
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| Polymethylmethacrylate (PMMA) Bone Cement
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| 2002V-0425
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| Laser Light Show
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| 2003D-0165
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| Current Good Manufacturing Practices for Medical Gases
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| 2003D-0380
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| Draft Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability
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| 2003D-0382
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| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
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| 2003D-0412
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| International Conference on Harmonisation; Draft Guidance on E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting
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| 2003N-0361
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| Anti-Counterfeit Drug Initiative
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| 2003P-0090
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| Removing Serzone (nefazodone) from the market Bristol-Myers
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| 2003P-0291
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| Enforce the law and prevent unlaw sale of contact lens
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| 2003Q-0401
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| Qualified Health Claim (QHC) Omega-3 Fatty Acids and Coronoary Heart Disease Health Claim
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| 2003V-0373
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| Laser Light Show
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| 2003V-0377
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| Laser Light Show
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| 2003V-0433
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| Laser Light Show
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| 1994D-0025
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| Interim GDL/Labeling Milk & Milk Products from Cows w/rbST
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| C 8583
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| No signature
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| Vol #:
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| 116
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| 1994V-0416
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| Laser Light Show
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| VRA
2
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| HFZ-300 to Laserworks, Inc.
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| Vol #:
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| 1
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| 1997P-0329
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| Require Quantitative Labeling of Caffeine Content
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| C 245
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| No signature
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| Vol #:
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| 8
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| C 246
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| No signature
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| Vol #:
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| 8
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| C 247
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| No signature
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| Vol #:
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| 8
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| C 248
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| No signature
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| Vol #:
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| 8
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| C 249
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| No signature
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| Vol #:
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| 8
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| C 250
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| No signature
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| Vol #:
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| 8
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| C 251
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| No signature
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| Vol #:
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| 8
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| C 252
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| No signature
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| Vol #:
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| 8
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| C 253
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| No signature
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| Vol #:
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| 8
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| C 254
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| No signature
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| Vol #:
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| 8
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| C 255
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| No signature
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| Vol #:
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| 8
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| C 256
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| No signature
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| Vol #:
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| 8
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| C 257
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| No signature
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| Vol #:
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| 8
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| C 258
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| No signature
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| Vol #:
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| 8
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| C 259
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| No signature
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| Vol #:
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| 8
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
11405
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| Aboca Herbs and Health
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| Vol #:
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| 87
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| LET
11406
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| Aboca Herbs and Health
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| Vol #:
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| 87
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| LET
11407
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| Aboca Herbs and Health
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| Vol #:
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| 88
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| LET
11408
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| Aboca Herbs and Health
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| Vol #:
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| 88
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| LET
11409
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| Aboca Herbs and Health
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| Vol #:
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| 88
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| LET
11410
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| Aboca Herbs and Health
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| Vol #:
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| 88
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| LET
11411
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| Aboca Herbs and Health
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| Vol #:
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| 88
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| LET
11412
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| Aboca Herbs and Health
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| Vol #:
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| 88
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| LET
11413
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| Aboca Herbs and Health
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| Vol #:
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| 88
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| LET
11414
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| Aboca Herbs and Health
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| Vol #:
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| 88
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| LET
11415
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| Aboca Herbs and Health
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| Vol #:
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| 88
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| LET
11416
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 88
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| LET
11417
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 88
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| LET
11418
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 88
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| LET
11419
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 88
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| LET
11420
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| Enzymatic Therapy Naural Medicines
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| Vol #:
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| 88
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| LET
11421
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| Oregon's Wild harvest
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| Vol #:
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| 88
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| LET
11422
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 88
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| LET
11423
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 88
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| LET
11424
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| Golden Temple of Oregon, Inc.
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| Vol #:
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| 88
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| LET
11425
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| Herb Phrm
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| Vol #:
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| 88
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| LET
11426
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| Herb Pharm
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| Vol #:
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| 88
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| LET
11427
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| Herb Pharm
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| Vol #:
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| 88
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| LET
11428
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| Generation Plus Inc.
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| Vol #:
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| 88
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| LET
11429
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 88
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| LET
11430
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 88
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| LET
11431
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| Food Science of Vermont
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| Vol #:
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| 88
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| LET
11432
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| Food Science of Vermont
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| Vol #:
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| 88
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| LET
11433
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| FoodScience of Vermont
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| Vol #:
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| 88
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| LET
11434
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| FoodScience of Vermont
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| Vol #:
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| 88
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| LET
11435
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| FoodScience of Vermont
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| Vol #:
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| 88
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| LET
11436
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| FoodScience of Vermont
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| Vol #:
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| 88
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| LET
11437
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| Natural Organics Inc.
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| Vol #:
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| 88
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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|
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| LET
724
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| HFS-800 to Colorado Biolabs, Inc.
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| Vol #:
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| 22
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| LET
725
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| HFS-800 to Highland Laboratories
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| Vol #:
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| 22
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| LET
726
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| HFS-800 to Aboca USA, Inc
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| Vol #:
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| 22
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| LET
727
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| HFS-800 to HerbsForever, Inc
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| Vol #:
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| 22
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| LET
728
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| HFS-800 to Herbal Source
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| Vol #:
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| 22
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| LET
729
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| HFS-800 to Pharmavite LLC
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| Vol #:
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| 22
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| LET
730
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| HFS-800 to Michael's Naturopathic Programs
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| Vol #:
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| 22
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| LET
731
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| HFS-800 to Lidtke Technologies Corporation
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| Vol #:
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| 22
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| LET
732
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| HFS-800 to Crosslinks International, Inc
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| Vol #:
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| 22
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| LET
733
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| HFS-800 to Peak Health Care Products, Inc.
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| Vol #:
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| 22
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| 1998D-0896
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| Medical Device Industry PMA shell development/modular review
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| GDL
2
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| Guideline
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| Vol #:
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| 1
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|
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| NAD
2
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| FDA
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| Vol #:
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| 1
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|
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| 1998P-0035
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| Exemption 21 CFR821 (b) Medical Device Tracking Requirements
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|
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| LET
1
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| HFZ-400 to Orthopedic Surgical Manufacturers Assn
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| Vol #:
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| 1
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7198
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| Leona & David Doyle
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| Vol #:
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| 303
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| C 7199
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| Stacy Fehl
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| Vol #:
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| 303
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| C 7200
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| Cherie L. Holcomb, PhD
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| Vol #:
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| 303
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| C 7201
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| Greta M. Bunting
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| Vol #:
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| 303
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| C 7202
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| Gina Brunell
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| Vol #:
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| 303
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| C 7203
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| Ruth Miller
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| Vol #:
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| 303
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| C 7204
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| Susan Love
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| Vol #:
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| 303
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| C 7205
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| Katie Desmond
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| Vol #:
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| 303
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| | | | | | | | |
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| C 7206
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| Beckie Doolan
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| Vol #:
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| 303
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| C 7207
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| Michele Bencivinni
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| Vol #:
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| 303
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| C 7208
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| Marianne Carnes
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| Vol #:
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| 303
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| C 7209
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| Gladys R. Boss
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| Vol #:
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| 303
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|
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| C 7210
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| Susan B. Kay, MD
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| Vol #:
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| 303
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| C 7211
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| Susan Riccobon
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| Vol #:
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| 303
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| C 7212
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| Phil Versage
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| Vol #:
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| 303
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|
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| C 7213
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| Bentley Yeager
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| Vol #:
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| 303
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|
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| C 7214
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| Cathy Kreibich
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| Vol #:
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| 303
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|
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| C 7215
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| Ira Fishburn
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| Vol #:
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| 303
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|
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| C 7216
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| Michael R. Tenga
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| Vol #:
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| 303
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|
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| C 7217
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| Marguerite Tyler, RN
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| Vol #:
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| 303
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|
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| C 7218
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| Elisa Frey
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| Vol #:
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| 303
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|
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| C 7219
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| Jennifer Crimi
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| Vol #:
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| 303
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| C 7220
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| Annette J. Prado
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| Vol #:
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| 303
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|
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| C 7221
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| Loretta Frediani
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| Vol #:
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| 303
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|
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| C 7222
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| Bill Frey
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| Vol #:
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| 303
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|
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| C 7223
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| Lisa Thomas Tucker
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| Vol #:
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| 303
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|
|
| C 7224
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| Julie S. Lachman
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| Vol #:
|
| 303
|
|
|
| C 7225
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| Eleanor Rosenthal
|
| Vol #:
|
| 303
|
|
|
| C 7226
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| Kim Griffin
|
| Vol #:
|
| 303
|
|
|
| 1998V-0817
|
| Variance for emission delay for BioFlex Professional Laser
|
|
|
| VRA
1
|
| HFZ-300 to Meditech International Inc.
|
| Vol #:
|
| 1
|
|
|
| 1999P-5106
|
| Identify Sources of Natural Flavorings
|
|
|
| C 19
|
| No signature
|
| Vol #:
|
| 2
|
|
|
| 2000N-1484
|
| Safety Reporting Requirements Human Drug/Biological Products
|
|
|
| REF
1
Tab A,
part 2, 3,
4, 5
Tab B, part
2, 3, 4,
5
|
| OMB Review 3/14/2003
|
| Vol #:
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| 7
|
|
|
| 2000P-1322
|
| Food Labeling and Allergen Contamination Control
|
|
|
| C 539
|
| No signature
|
| Vol #:
|
| 30
|
|
|
| C 540
|
| No signature
|
| Vol #:
|
| 30
|
|
|
| C 541
|
| No signature
|
| Vol #:
|
| 30
|
|
|
| C 542
|
| No signature
|
| Vol #:
|
| 30
|
|
|
| 2002P-0294
|
| Polymethylmethacrylate (PMMA) Bone Cement
|
|
|
| LET
1
|
| HFZ-400 to Orthopedic Surgical Manufacturers Assn
|
| Vol #:
|
| 5
|
|
| | | | | | | | |
|
|
| 2002V-0425
|
| Laser Light Show
|
|
|
| LET 1
|
| HFZ-343 to MGM Grand Hotel & Casino
|
| Vol #:
|
| 1
|
|
|
| 2003D-0165
|
| Current Good Manufacturing Practices for Medical Gases
|
|
|
| C
27
|
| BOC Gases
|
| Vol #:
|
| 1
|
|
|
| C
28
|
| Praxair, Inc. (Praxair)
|
| Vol #:
|
| 1
|
|
|
| C
29
|
| Michigan Home Health Assn (MHHA)
|
| Vol #:
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| 1
|
|
|
| C
30
|
| Compressed Gas Assn (CGA)
|
| Vol #:
|
| 1
|
|
|
| C
31
|
| AGA Gas, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2003D-0380
|
| Draft Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability
|
|
|
| C
3
|
| AstraZeneca Pharmaceuticals, LP
|
| Vol #:
|
| 1
|
|
|
| C
4
|
| Umetrics, Inc.
|
| Vol #:
|
| 1
|
|
|
| C
5
|
| Abbott Laboratories
|
| Vol #:
|
| 1
|
|
|
| C
6
|
| Cambrex Corporation (Cambrex)
|
| Vol #:
|
| 1
|
|
|
| 2003D-0382
|
| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
|
|
|
| C
5
|
| VPCI, Inc.
|
| Vol #:
|
| 1
|
|
|
| C
6
|
| Millipore Corporation (Millipore)
|
| Vol #:
|
| 1
|
|
|
| C
7
|
| Alcon Laboratories, Inc.
|
| Vol #:
|
| 1
|
|
|
| C
8
|
| Johnson-Johnson
|
| Vol #:
|
| 1
|
|
|
| C
9
|
| Pfizer, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2003D-0412
|
| International Conference on Harmonisation; Draft Guidance on E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting
|
|
|
| C
5
|
| Millennium Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2003N-0361
|
| Anti-Counterfeit Drug Initiative
|
|
|
| C
5
|
| PharmaDocs, LLC
|
| Vol #:
|
| 3
|
|
|
| C
6
|
| InkShore Technologies
|
| Vol #:
|
| 3
|
|
|
| C
7
|
| Plasma Protein Therapeutics Assn (PPTA)
|
| Vol #:
|
| 3
|
|
|
| C
8
|
| DeLaRue
|
| Vol #:
|
| 3
|
|
|
| C
9
|
| Isotech Laboratories, Inc.
|
| Vol #:
|
| 3
|
|
|
| C
10
|
| DeKieffer & Horgan
|
| Vol #:
|
| 3
|
|
|
| 2003P-0090
|
| Removing Serzone (nefazodone) from the market Bristol-Myers
|
|
|
| SUP
1
|
| Public Citizen
|
| Vol #:
|
| 1
|
|
|
| 2003P-0291
|
| Enforce the law and prevent unlaw sale of contact lens
|
|
|
| C 60
|
| Dr. Helen Kim
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
|
| 2003Q-0401
|
| Qualified Health Claim (QHC) Omega-3 Fatty Acids and Coronoary Heart Disease Health Claim
|
|
|
| ACK
2
|
| HFS-800 to Emord & Associates PC
|
| Vol #:
|
| 2
|
|
|
| C
2
Tab
A, B, C
|
| Ocean Nutrition Canada
|
| Vol #:
|
| 3
|
|
|
| LET
2
|
| Emord & Associates, PC
|
| Vol #:
|
| 2
|
|
|
| LET
3
|
| Oregon School of Medicine
|
| Vol #:
|
| 2
|
|
|
| LET
4
|
| Enig Associates, Inc.
|
| Vol #:
|
| 2
|
|
|
| MM
1
|
| Meeting Between Emord & Associates and FDA
|
| Vol #:
|
| 2
|
|
|
| SUP
1
Attachment,
Reference 1, 18-20
|
| Emord & Associates PC
|
| Vol #:
|
| 2
|
|
|
| 2003V-0373
|
| Laser Light Show
|
|
|
| VRA
1
|
| HFZ-300 to Eagle River Bowl, LLC
|
| Vol #:
|
| 1
|
|
|
| 2003V-0377
|
| Laser Light Show
|
|
|
| VRA
1
|
| HFZ-300 to Wild Country
|
| Vol #:
|
| 1
|
|
|
| 2003V-0433
|
| Laser Light Show
|
|
|
| VRA
1
|
| HFZ-300 to Vandenberg Community Center
|
| Vol #:
|
| 1
|
|
|