| | | | | | | | | | |
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|
| Dockets Entered
On December 1, 2003
Table of Contents
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|
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| Docket #
|
| Title
|
|
|
|
|
| 1975N-0183H
|
| Health-Care Antiseptic Drug Products for OTC Human Use
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
| 1998F-0196
|
| Safe use of Selenium Yeast in Animal Feeds
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
| 2003N-0502
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Study to Measure the Compliance of Prescribers with the Contraindication of the Use of bTriptansb in Migraine Headac
|
|
|
|
|
|
| 2003P-0544
|
| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
|
|
|
| 1975N-0183H
|
| Health-Care Antiseptic Drug Products for OTC Human Use
|
|
|
| EREG 1
|
| NUMBER NOT USED
|
| Vol #:
|
| 200
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
| LET
11665
|
| Rexall
|
| Vol #:
|
| 92
|
|
|
| LET
11666
|
| Rexall
|
| Vol #:
|
| 92
|
|
|
| LET
11667
|
| Rexall
|
| Vol #:
|
| 92
|
|
|
| LET
11668
|
| Rexall
|
| Vol #:
|
| 92
|
|
|
| LET
11669
|
| Rexall
|
| Vol #:
|
| 92
|
|
|
| LET
11670
|
| Rexall
|
| Vol #:
|
| 92
|
|
|
| LET
11671
|
| Rexall
|
| Vol #:
|
| 92
|
|
|
| LET
11672
|
| Rexall
|
| Vol #:
|
| 92
|
|
|
| LET
11673
|
| Rexall
|
| Vol #:
|
| 92
|
|
|
| LET
11674
|
| Rexall
|
| Vol #:
|
| 92
|
|
|
| LET
11675
|
| Rexall
|
| Vol #:
|
| 92
|
|
|
| LET
11676
|
| Rexall
|
| Vol #:
|
| 92
|
|
|
| LET
11677
|
| Rexall
|
| Vol #:
|
| 92
|
|
|
| LET
11678
|
| Rexall
|
| Vol #:
|
| 92
|
|
|
| LET
11679
|
| Rexall
|
| Vol #:
|
| 92
|
|
|
| LET
11680
|
| ChildLife Nutrition for Kids
|
| Vol #:
|
| 92
|
|
|
| LET
11681
|
| Bayer Healthcare Consumer Care Division
|
| Vol #:
|
| 92
|
|
|
| LET
11682
|
| Trader Joe's Company
|
| Vol #:
|
| 92
|
|
|
| LET
11683
|
| Ancient Herbs, Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11684
|
| PhytoPharmica Nautral Medicines
|
| Vol #:
|
| 92
|
|
|
| LET
11685
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 92
|
|
|
| LET
11686
|
| PhytoPharmica Nautral Medicines
|
| Vol #:
|
| 92
|
|
|
| LET
11687
|
| Melaleuca, Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11688
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 92
|
|
|
| LET
11689
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 92
|
|
| | | | | | | |
|
|
| LET
11690
|
| Nature's Life
|
| Vol #:
|
| 92
|
|
|
| LET
11691
|
| Twin Laboratories, Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11692
|
| Twin Laboratories, Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11693
|
| Indian Botanic Gardens, Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11694
|
| Indiana Botanic Gardens, Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11695
|
| Indiana Botanic Gardens, Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11696
|
| Solstice Medicine Company
|
| Vol #:
|
| 92
|
|
|
| LET
11697
|
| Solstice Medicine Company
|
| Vol #:
|
| 92
|
|
|
| LET
11698
|
| Solstice Medicine Company
|
| Vol #:
|
| 92
|
|
|
| LET
11699
|
| Indiana Botanic Gardens, Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11700
|
| Source Naturals
|
| Vol #:
|
| 92
|
|
|
| LET
11701
|
| Source Naturals
|
| Vol #:
|
| 92
|
|
|
| LET
11702
|
| Twin Laboratories, Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11703
|
| NOW Foods
|
| Vol #:
|
| 92
|
|
|
| LET
11704
|
| National Vitamin Company, Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11705
|
| National Vitamin Company, Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11706
|
| National Vitamin Company, Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11707
|
| FoodScience of Vermont
|
| Vol #:
|
| 92
|
|
|
| LET
11708
|
| FoodScience of Vermont
|
| Vol #:
|
| 92
|
|
|
| LET
11709
|
| FoodScience of Vermont
|
| Vol #:
|
| 92
|
|
|
| LET
11710
|
| FoodScience of Vermont
|
| Vol #:
|
| 92
|
|
|
| LET
11711
|
| National Vitamin Company, Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11712
|
| National Vitamin Company, Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11713
|
| Nutravail Technologies Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11714
|
| Nutravail Technologies Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11715
|
| Body Ammo Nutraceuticals, LLC
|
| Vol #:
|
| 92
|
|
|
| LET
11716
|
| MI Foods
|
| Vol #:
|
| 92
|
|
|
| LET
11717
|
| Nature's Life
|
| Vol #:
|
| 92
|
|
|
| LET
11718
|
| MI Foods
|
| Vol #:
|
| 92
|
|
|
| LET
11719
|
| Standard Process Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11720
|
| Standard Process Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11721
|
| Standard Process Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11722
|
| Standard Process Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11723
|
| Standard Process Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11724
|
| Standard Process Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11725
|
| Standard Process Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11726
|
| Standard Process Inc.
|
| Vol #:
|
| 92
|
|
| | | | | | | | |
|
|
| LET
11727
|
| Standard Process Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11728
|
| Standard Process Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11729
|
| National Vitamin Company, Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11730
|
| National Vitamin Company, Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11731
|
| Source Naturals
|
| Vol #:
|
| 92
|
|
|
| LET
11732
|
| Source Naturals
|
| Vol #:
|
| 92
|
|
|
| LET
11733
|
| National Vitamin Company, Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11734
|
| National Vitamin Company, Inc.
|
| Vol #:
|
| 92
|
|
|
| LET
11735
|
| Health From the Sun
|
| Vol #:
|
| 92
|
|
|
| LET
11736
|
| Health From The Sun
|
| Vol #:
|
| 92
|
|
|
| LET
11737
|
| Health From The Sun
|
| Vol #:
|
| 92
|
|
|
| LET
11738
|
| Health From The Sun
|
| Vol #:
|
| 92
|
|
|
| LET
11739
|
| Health From The Sun
|
| Vol #:
|
| 92
|
|
|
| LET
11740
|
| Health From The Sun
|
| Vol #:
|
| 92
|
|
|
| 1998F-0196
|
| Safe use of Selenium Yeast in Animal Feeds
|
|
|
| EREG 1
|
| sashaw, barb
|
| Vol #:
|
| 1
|
|
|
| 2001B-0431
|
| Permitted Daily Exposures for two solvents, N-Methylpyrrolld
|
|
|
| EC 1
|
| ZHONG, JACK
|
| Vol #:
|
| 1
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
| EC 2
|
| Henry, Joan
|
| Vol #:
|
| 39
|
|
|
| EC 3
|
| Gerling, Jo Ann
|
| Vol #:
|
| 39
|
|
|
| EC 4
|
| Sniffen, Marie
|
| Vol #:
|
| 39
|
|
|
| EC 5
|
| Juliano, Louise
|
| Vol #:
|
| 39
|
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
|
|
| EC 299
|
| Savello, Paul
|
| Vol #:
|
| 15
|
|
|
| EC 311
|
| Thoma, Bryan
|
| Vol #:
|
| 15
|
|
|
| EC 312
|
| martin, cecile
|
| Vol #:
|
| 15
|
|
|
| EC 313
|
| Loo, K
|
| Vol #:
|
| 15
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
| EC 317
|
| Warren, Patricia
|
| Vol #:
|
| 17
|
|
|
| EC 318
|
| Losinger, John
|
| Vol #:
|
| 17
|
|
|
| EC 320
|
| Hamza, Akila
|
| Vol #:
|
| 17
|
|
|
| EC 321
|
| Kraus, Diane
|
| Vol #:
|
| 17
|
|
|
| EC 322
|
| CIACCIO, LUANNE
|
| Vol #:
|
| 17
|
|
| | | | | | | | |
|
|
| EC 323
|
| Brophy, Sean
|
| Vol #:
|
| 17
|
|
|
| EC 324
|
| Geiger, James
|
| Vol #:
|
| 17
|
|
|
| EC 325
|
| kirk, robert
|
| Vol #:
|
| 17
|
|
|
| EC 327
|
| Industry, Concerned w/n
|
| Vol #:
|
| 27
|
|
|
| EC 328
|
| Benincasa, Frank
|
| Vol #:
|
| 17
|
|
|
| 2003D-0195
|
| Draft Guidance for Industry on Necessity of the Use of Food Product Categories in Registration of Food Facilities
|
|
|
| EC 17
|
| tantawy, ahmed
|
| Vol #:
|
| 1
|
|
|
| 2003D-0290
|
| Compounding of Drugs for Use in Animals Compliance Policy Guide
|
|
|
| EC 11
|
| Pelligrinelli, Susan
|
| Vol #:
|
| 1
|
|
|
| 2003D-0478
|
| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
|
|
|
| EC 5
|
| Johnson, Karen
|
| Vol #:
|
| 1
|
|
|
| EC 6
|
| Mitchel, Jules
|
| Vol #:
|
| 1
|
|
|
| 2003N-0069
|
| FDA Task Force on Consumer Health Info for Better Nutrition
|
|
|
| EC 89
|
| Phillips, Giovanna
|
| Vol #:
|
| 1
|
|
|
| EC 90
|
| Roades, Shawn
|
| Vol #:
|
| 1
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
| EREG 2
|
| Jones, Jessica
|
| Vol #:
|
| 3
|
|
|
| EREG 3
|
| Brooks, Walt
|
| Vol #:
|
| 3
|
|
|
| EREG 4
|
| Thiagarajan , Tangavelu
|
| Vol #:
|
| 3
|
|
|
| 2003N-0338
|
| Obesity
|
|
|
| EC 76
|
| Garrick, Johanna
|
| Vol #:
|
| 6
|
|
|
| EC 77
|
| Bergman, Donald
|
| Vol #:
|
| 6
|
|
|
| EC 78
|
| Wyatt, Holly
|
| Vol #:
|
| 6
|
|
|
| EC 79
|
| Dumat, Linda
|
| Vol #:
|
| 6
|
|
|
| EC 80
|
| Carlin, Cris
|
| Vol #:
|
| 6
|
|
|
| EC 82
|
| Wann, Marilyn
|
| Vol #:
|
| 6
|
|
|
| EC 83
|
| Wheeler, Joy
|
| Vol #:
|
| 6
|
|
|
| EC 84
|
| Mercadante, Curt
|
| Vol #:
|
| 6
|
|
|
| EC 85
|
| Goldring, Jay
|
| Vol #:
|
| 6
|
|
|
| EC 86
|
| Brown, Janice
|
| Vol #:
|
| 6
|
|
|
| EC 89
|
| Nguyen, Susan L. X.
|
| Vol #:
|
| 6
|
|
|
| EC 91
|
| Rosenfeld, William
|
| Vol #:
|
| 6
|
|
|
| EC 92
|
| Maruch, Stef
|
| Vol #:
|
| 6
|
|
| | | | | | | | |
|
|
| EC 93
|
| Malkin, Deborah
|
| Vol #:
|
| 6
|
|
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
|
|
| EC 65
|
| Lessley, Zack
|
| Vol #:
|
| 3
|
|
|
| EC 66
|
| Burgar, Vicki
|
| Vol #:
|
| 3
|
|
|
| EC 67
|
| Tubiak, Cheryl
|
| Vol #:
|
| 3
|
|
|
| EC 68
|
| Levine, Lynne
|
| Vol #:
|
| 3
|
|
|
| EC 69
|
| Stelma, Diane
|
| Vol #:
|
| 3
|
|
|
| EC 70
|
| Hannah, Candida
|
| Vol #:
|
| 3
|
|
|
| EC 71
|
| Gee, Kathy
|
| Vol #:
|
| 3
|
|
|
| EC 72
|
| Watts, Andrew
|
| Vol #:
|
| 3
|
|
|
| EC 73
|
| Harrington, Tammy
|
| Vol #:
|
| 3
|
|
|
| EC 74
|
| Ellison, Laneth
|
| Vol #:
|
| 3
|
|
|
| EC 75
|
| Ratliff, Beverly
|
| Vol #:
|
| 3
|
|
|
| EC 76
|
| Wardwell, Brian
|
| Vol #:
|
| 3
|
|
|
| EC 77
|
| Mcilrath, Christine
|
| Vol #:
|
| 3
|
|
|
| EC 78
|
| Juilfs, Glenna
|
| Vol #:
|
| 3
|
|
|
| EC 79
|
| Beale, Abby
|
| Vol #:
|
| 3
|
|
|
| EC 80
|
| Sackett, John
|
| Vol #:
|
| 3
|
|
|
| EC 81
|
| Lee, Beth
|
| Vol #:
|
| 3
|
|
|
| EC 82
|
| MacNeill, Karen
|
| Vol #:
|
| 3
|
|
|
| EC 83
|
| Hulsey, Carrie
|
| Vol #:
|
| 3
|
|
|
| EC 84
|
| Wawrzynski, Stefan
|
| Vol #:
|
| 3
|
|
|
| EC 85
|
| Cattellion, Carine
|
| Vol #:
|
| 3
|
|
|
| EC 86
|
| Dameorn, Mary
|
| Vol #:
|
| 3
|
|
|
| EC 87
|
| Garcia, Frank
|
| Vol #:
|
| 3
|
|
|
| EC 88
|
| lebanik, brian
|
| Vol #:
|
| 3
|
|
|
| EC 89
|
| Chartier, Chrisanne
|
| Vol #:
|
| 3
|
|
|
| EC 91
|
| weiner, robert
|
| Vol #:
|
| 3
|
|
|
| EC 92
|
| Benus, Michelle
|
| Vol #:
|
| 3
|
|
|
| EC 93
|
| Jakopak, Peggy
|
| Vol #:
|
| 3
|
|
|
| EC 94
|
| ONeal, Misty
|
| Vol #:
|
| 3
|
|
|
| EC 95
|
| Allen, Judy
|
| Vol #:
|
| 3
|
|
|
| EC 96
|
| Baxter, Merryann
|
| Vol #:
|
| 3
|
|
|
| EC 97
|
| Westfall, Apryl
|
| Vol #:
|
| 3
|
|
|
| EC 98
|
| Morgan, Stewart
|
| Vol #:
|
| 3
|
|
|
| 2003N-0496
|
| Food Labeling: Health Claims; Dietary Guidance
|
|
| | | | | | | | |
|
|
| EC 1
|
| sashaw, barb
|
| Vol #:
|
| 1
|
|
|
| 2003N-0502
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Study to Measure the Compliance of Prescribers with the Contraindication of the Use of bTriptansb in Migraine Headac
|
|
|
|
|
|
| BKG 1
|
| Draft Questions
|
| Vol #:
|
| 1
|
|
|
| 2003P-0544
|
| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
|
|
|
| ACK 1
|
| HFA-305
|
| Vol #:
|
| 1
|
|
|
| CP
1
Tab
1, 2, 3, 4,
5, 6, 7,
8, 9, 10,
11, 12,
13, 14
|
| Center for Food Safety & Public Citizen, Critical Mass
|
| Vol #:
|
| 1
|
|
|