| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On March 3, 2004
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1995N-0304
|
| Ephedrine Alkaloids: Reports of Adverse Events; Availability
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
|
|
| 1999F-4372
|
| National Fisheries Institute and the Louisiana Dep of Agricu
|
|
|
|
|
| 1999F-5321
|
| Food Safety & Inspection service safe use of ionizing radiai
|
|
|
|
|
| 1999F-5322
|
| Ionizing Radiation for the Treatment of Food
|
|
|
|
|
| 1999F-5522
|
| Ionizing radiation /control of Food-borne pathogens safe use
|
|
|
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
|
|
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
|
|
|
|
| 2001F-0047
|
| Foodborne pathogens in raw-frozen-cooked-partially cooked
|
|
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
|
|
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
|
|
| 2003D-0386
|
| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
|
|
|
|
|
| 2003D-0522
|
| Draft Guidance for Industry and FDA Staff; Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests; Availability
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| 2003N-0496
|
| Food Labeling: Health Claims; Dietary Guidance
|
|
|
|
|
| 2004D-0002
|
| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
|
|
|
|
|
| 2004D-0028
|
| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
|
|
|
|
|
| 2004V-0096
|
| Laser Light Show
|
|
|
|
|
| 1995N-0304
|
| Ephedrine Alkaloids: Reports of Adverse Events; Availability
|
|
|
| EMC 1256
|
| D. Sanville
|
| Vol #:
|
| 378
|
|
|
|
|
| EMC 1257
|
| G. Haring
|
| Vol #:
|
| 378
|
|
|
|
|
| EMC 1258
|
| No signature
|
| Vol #:
|
| 378
|
|
|
|
|
| EMC 1259
|
| Claudia
|
| Vol #:
|
| 378
|
|
|
|
|
| EMC 1260
|
| J. Mann
|
| Vol #:
|
| 378
|
|
|
|
|
| EMC 1261
|
| S. Johnston
|
| Vol #:
|
| 378
|
|
|
|
|
| EMC 1262
|
| D. Rosene
|
| Vol #:
|
| 378
|
|
|
|
|
| EMC 1263
|
| No signature
|
| Vol #:
|
| 378
|
|
|
|
|
| EMC 1264
|
| A. Stowe
|
| Vol #:
|
| 378
|
|
|
|
|
| EMC 1265
|
| R. Martino
|
| Vol #:
|
| 378
|
|
|
|
|
| EMC 1266
|
| H. Curb
|
| Vol #:
|
| 378
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
| | | | | | | |
|
|
|
|
| LET
12923
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12924
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12925
|
| Enzymatic Thearpy Natural Medicines
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12926
|
| Body Wise International, Inc.
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12927
|
| Bayer HealthCare Consumer Care Division
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12928
|
| Basic Foods, Inc.
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12929
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12930
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12931
|
| Sunrider International
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12932
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12933
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12934
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12935
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12936
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12937
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12938
|
| Integrative Therapeutics Inc.
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12939
|
| Melaleuca, Inc.
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12940
|
| Body Wise International, Inc.
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12941
|
| Bee-Alive Inc.
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12942
|
| Synergy Worldwide
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12943
|
| Solgar Vitamin and Herb
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12944
|
| Solgar Vitamin and Herb
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12945
|
| Your Vitamins
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12946
|
| Your Vitamins
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12947
|
| Your Vitamins
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12948
|
| Tabak's Health Products
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12949
|
| Nature's Sunshine Products, Inc.
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12950
|
| Nature's Sunshine Products, Inc.
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12951
|
| Meditrend, Inc.
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12952
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12953
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12954
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12955
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12956
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12957
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 105
|
|
|
|
|
| LET
12958
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 105
|
|
| | | | | | | | |
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
|
|
| EMC 4159
|
| T. Hi
|
| Vol #:
|
| 304
|
|
|
|
|
| EMC 4160
|
| L. Bernhard
|
| Vol #:
|
| 304
|
|
|
|
|
| EMC 4161
|
| R. Steele
|
| Vol #:
|
| 304
|
|
|
|
|
| 1999F-4372
|
| National Fisheries Institute and the Louisiana Dep of Agricu
|
|
|
|
|
| EMC 466
|
| D. Shively
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 467
|
| D. Shively
|
| Vol #:
|
| 8
|
|
|
|
|
| 1999F-5321
|
| Food Safety & Inspection service safe use of ionizing radiai
|
|
|
|
|
| EMC 369
|
| D. Shively
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 370
|
| D. Shively
|
| Vol #:
|
| 8
|
|
|
|
|
| 1999F-5322
|
| Ionizing Radiation for the Treatment of Food
|
|
|
|
|
| EMC 368
|
| D. Shively
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC 369
|
| D. Shively
|
| Vol #:
|
| 6
|
|
|
|
|
| 1999F-5522
|
| Ionizing radiation /control of Food-borne pathogens safe use
|
|
|
|
|
| EMC 371
|
| D. Shively
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC 372
|
| D. Shively
|
| Vol #:
|
| 6
|
|
|
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
|
|
|
|
| EMC 4163
|
| E. Taylor
|
| Vol #:
|
| 515
|
|
|
|
|
| EMC 4164
|
| J. Heller
|
| Vol #:
|
| 515
|
|
|
|
|
| EMC 4165
|
| J. Heller
|
| Vol #:
|
| 515
|
|
|
|
|
| EMC 4166
|
| J. Heller
|
| Vol #:
|
| 515
|
|
|
|
|
| EMC 4167
|
| J. Heller
|
| Vol #:
|
| 515
|
|
|
|
|
| EMC 4168
|
| J. Heller
|
| Vol #:
|
| 515
|
|
|
|
|
| EMC 4169
|
| K. Hubbard
|
| Vol #:
|
| 515
|
|
|
|
|
| EMC 4170
|
| C. Arbeit
|
| Vol #:
|
| 515
|
|
|
|
|
| EMC 4171
|
| D. Shively
|
| Vol #:
|
| 515
|
|
|
|
|
| EMC 4172
|
| R. Sonnenberg
|
| Vol #:
|
| 515
|
|
|
|
|
| EMC 4173
|
| R. Sonnenberg
|
| Vol #:
|
| 515
|
|
|
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
|
|
| EMC 527
|
| J. Cordova
|
| Vol #:
|
| 24
|
|
|
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
|
|
|
|
| EMC 758
|
| K. DesMaisons, PhD
|
| Vol #:
|
| 33
|
|
| | | | | | | | |
|
|
|
|
| EMC 3294
|
| D. E. Gibson
|
| Vol #:
|
| 165
|
|
|
|
|
| EMC 3295
|
| B. Burgess
|
| Vol #:
|
| 165
|
|
|
|
|
| EMC 3296
|
| P. Tyndale
|
| Vol #:
|
| 165
|
|
|
|
|
| EMC 3297
|
| M. Barbis
|
| Vol #:
|
| 165
|
|
|
|
|
| EMC 3298
|
| S. Meredith
|
| Vol #:
|
| 165
|
|
|
|
|
| EMC 3299
|
| L. Ashton
|
| Vol #:
|
| 165
|
|
|
|
|
| EMC 3300
|
| J. Hillard
|
| Vol #:
|
| 165
|
|
|
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
|
|
|
|
| EMC 3157
|
| A. Robben
|
| Vol #:
|
| 252
|
|
|
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
|
|
| EMC 151
|
| C. Johnson
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 152
|
| L. Gonzales
|
| Vol #:
|
| 3
|
|
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
|
|
| EMC
315
|
| Mission Possible Intl
|
| Vol #:
|
| 6
|
|
|
|
|
| 2003D-0386
|
| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
|
|
|
|
|
| EMC
2
Attachment
|
| Pfizer, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003D-0522
|
| Draft Guidance for Industry and FDA Staff; Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests; Availability
|
|
|
|
|
| EMC
2
|
| LifePoint, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
3
|
| One Source Toxicology Laboratory, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
4
|
| National On-site Testing Assn
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
5
|
| Avitar Technologies, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
| EMC 139
|
| C. Cowan
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 140
|
| S. Reagan
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 141
|
| B. Sachau
|
| Vol #:
|
| 3
|
|
|
|
|
| 2003N-0496
|
| Food Labeling: Health Claims; Dietary Guidance
|
|
|
|
|
| EMC
10
|
| Council for Responsible Nutrition (CRN)
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC
11
|
| California Walnut Commission (CWC)
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC
12
Attachment
|
| Mercatus Center at George Mason University
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC
13
|
| Burdock Group
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC
14
|
| International Dairy Foods Assn (IDFA)
|
| Vol #:
|
| 7
|
|
|
|
|
| 2004D-0002
|
| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
|
|
