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| Dockets Entered
On March 1, 2004
Table of Contents
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| Docket #
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| Title
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| 1991N-0384H
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| Nutrient Content Claims, Definition of Term: Healthy
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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| 1996N-0417
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| CGMP in Mfg. Packing or Holding Dietary Supplements
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| 1996P-0500
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| Amend "Healthy" Definition re: Sodium Levels
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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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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| 2000N-1449
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| Changes to an Approved NDA or ANDA; Agency Information Collection
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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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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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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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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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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-0338
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| Obesity
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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-0496
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| Food Labeling: Health Claims; Dietary Guidance
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| 2003N-0529
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| Amending the MedWatch Forms to Collect Postmarketing Adverse Event Data Relating to Race and Ethnicity
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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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| 2004V-0094
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| Laser Light Show
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| 1991N-0384H
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| Nutrient Content Claims, Definition of Term: Healthy
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| REF
1
Tab
A, B
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| OMB Review for 02/20/2003
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| Vol #:
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| 17
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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| REF
12
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| OMB Review 02/11/2004
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| Vol #:
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| 393
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| 1996N-0417
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| CGMP in Mfg. Packing or Holding Dietary Supplements
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| C
250
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| Consumer Healthcare Products Assn (CHPA)
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| Vol #:
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| 41
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| 1996P-0500
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| Amend "Healthy" Definition re: Sodium Levels
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| REF
1
Tab A,
B, C
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| OMB Review 02/20/2003
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| Vol #:
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| 14
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| 1999F-4372
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| National Fisheries Institute and the Louisiana Dep of Agricu
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| EMC 462
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| R. Vegh
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| Vol #:
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| 8
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| EMC 463
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| L.& I. Berman
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| Vol #:
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| 8
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| EMC 464
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| L & I Berman
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| Vol #:
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| 8
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| EMC 465
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| L & I Berman
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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 365
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| R. Vegh
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| Vol #:
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| 8
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| EMC 366
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| L. & I. Berman
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| Vol #:
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| 8
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| EMC 367
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| L. & I. Berman
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| Vol #:
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| 8
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| EMC 368
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| L. & I. Berman
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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 364
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| R. Vegh
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| Vol #:
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| 6
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| EMC 365
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| L. & I. Berman
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| Vol #:
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| 6
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| EMC 366
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| L. & I. Berman
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| Vol #:
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| 6
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| EMC 367
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| L. & I. Berman
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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 367
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| R. Vegh
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| Vol #:
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| 6
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| EMC 368
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| L. & I. Berman
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| Vol #:
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| 6
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| EMC 369
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| L. & I. Berman
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| Vol #:
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| 6
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| EMC 370
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| L. & I. Berman
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| Vol #:
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| 6
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| EMC 155
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| X. Kovah
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| Vol #:
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| 2
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| 2000N-1449
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| Changes to an Approved NDA or ANDA; Agency Information Collection
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| EMC
2
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| Merck & Co., Inc.
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| Vol #:
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| 1
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| 2001F-0047
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| Foodborne pathogens in raw-frozen-cooked-partially cooked
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| EMC 469
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| R. Vegh
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| Vol #:
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| 8
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| EMC 470
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| L. & I. Berman
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| Vol #:
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| 8
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| EMC 471
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| L. & I. Berman
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| Vol #:
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| 8
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| EMC 472
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| L. & I. Berman
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| Vol #:
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| 8
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| C 361
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| F.B. Beyer
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| Vol #:
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| 162
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| EMC 3022
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| R. L
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| Vol #:
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| 165
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| EMC 3023
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| N. Williams
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| Vol #:
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| 165
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| EMC 3024
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| M. Melody
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| Vol #:
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| 165
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| EMC 3025
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| Rev. A. J. Samonds
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| Vol #:
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| 165
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| EMC 3026
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| L. Norelli
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| Vol #:
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| 165
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| EMC 3027
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| L. Roden
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| Vol #:
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| 165
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| EMC 3028
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| C. Williams
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| Vol #:
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| 165
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| EMC 3029
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| R. Weeks
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| Vol #:
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| 165
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| EMC 3156
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| M. Bultman
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| Vol #:
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| 252
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| EMC 1220
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| S. Wisnia
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| Vol #:
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| 5
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| EMC 148
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| Q. Lany
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| Vol #:
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| 3
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| EMC 149
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| T. Raine
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| Vol #:
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| 3
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| EMC 150
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| C. Pado
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| Vol #:
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| 3
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| EMC 13
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| V. Gay
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| Vol #:
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| 4
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| TR
3
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| New FDA Bioterrorism Act Registration and Prior Notice Interim Final Rules
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| Vol #:
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| 22
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| TR
4
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| New FDA Bioterrorism Act Registration and Prior Notice Interim Final Rules
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| Vol #:
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| 23
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| TR
5
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| New FDA Bioterrorism Act Registration and Prior Notice Interim Final Rules
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| Vol #:
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| 24
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| TR
6, continued
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| New FDA Bioterrorism Act Registration and Prior Notice Interim Final Rules
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| Vol #:
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| 25
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| TR
7
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| New FDA Bioterrorism Act Registration and Prior Notice Interim Final Rules
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| Vol #:
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| 26
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| TR
2
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| New FDA Bioterrorism Act Registration and Prior Notice Interim Final Rules
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| Vol #:
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| 24
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| TR
3
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| New FDA Bioterrorism Act Registration and Prior Notice Interim Final Rules
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| Vol #:
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| 25
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| TR
4
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| New FDA Bioterrorism Act Registration and Prior Notice Interim Final Rules
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| Vol #:
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| 26
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| TR
5
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| New FDA Bioterrorism Act Registration and Prior Notice Interim Final Rules
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| Vol #:
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| 27
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| TR
6
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| New FDA Bioterrorism Act Registration and Prior Notice Interim Final Rules
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| Vol #:
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| 28
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| |
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 312
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| Dr. J. Bowen
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| Vol #:
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| 6
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| | | | | | | | |
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| EMC 313
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| Dr. B. Martini
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| Vol #:
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| 6
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| EMC 314
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| Dr. B. Martini
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| Vol #:
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| 6
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| |
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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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| EMC 136
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| A. Villa
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| Vol #:
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| 3
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| EMC 137
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| H. Bellow
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| Vol #:
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| 3
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| EMC 138
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| J. Lee
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| Vol #:
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| 3
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| 2003N-0338
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| Obesity
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| EMC 52
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| T. Dayton
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| Vol #:
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| 10
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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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| EMC 47
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| W. McMullin
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| Vol #:
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| 9
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|
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| 2003N-0496
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| Food Labeling: Health Claims; Dietary Guidance
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| EMC
7
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| Life Extension Foundation Buyers' Club,Durk Pearson and Sandy Shaw;Julian M. Whitaker, MD and A
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| Vol #:
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| 6
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| EMC
8
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| Consumer Healthcare Products Assn (CHPA)
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| Vol #:
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| 6
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| EMC
9
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| Kraft Foods (Kraft)
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| Vol #:
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| 6
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|
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| 2003N-0529
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| Amending the MedWatch Forms to Collect Postmarketing Adverse Event Data Relating to Race and Ethnicity
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| EMC
7
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| National Institute of Health (NIH)
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| Vol #:
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| 1
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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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| ACK
3
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| HFS-830 to Martin J Hahn
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| Vol #:
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| 2
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| C
3
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| Martek Biosciences Corporation
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| Vol #:
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| 2
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| QHC
2
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| Martek Biosciences Corporation
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| Vol #:
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| 4
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| 2004V-0094
|
| Laser Light Show
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| ACK
1
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| HFA-305 to Inflatable Promotions and Searchlights
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| Vol #:
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| 1
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| VAR
1
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| Inflatable Promotions and Searchlights
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| Vol #:
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| 1
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