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| Dockets Entered
On October 9, 2003
Table of Contents
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| Docket #
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| Title
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| 1981N-0033P
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| Antiplaque & Antiplaque-Related Claims
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|
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| 1986F-0208
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| MYCO-PROTEIN DERIVED FROM FUSARIUM GRANINEARUM SOURCE PRO
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|
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| 1997P-0329
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| Require Quantitative Labeling of Caffeine Content
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|
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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|
|
| 1997V-0231
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| Laser light show
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|
|
| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
|
|
|
| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
|
|
| 1999P-2630
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| Establish a Daily Value for "added sugars"
|
|
|
| 2000N-1484
|
| Safety Reporting Requirements Human Drug/Biological Products
|
|
|
| 2000P-0685
|
| Revise of Yogurt Standards
|
|
|
| 2000P-1275
|
| Health Claim: Vegetable oil sterol esters & coronary heart d
|
|
|
| 2000P-1276
|
| Health Claim: Plant stanol esters and heart disease
|
|
|
| 2000V-1247
|
| Laser Light Show
|
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
| 2002D-0324
|
| Bioengineered Plants for Use in Humans and Animals
|
|
|
| 2003D-0060
|
| Part11, Electronic records, electronic signatures scope
|
|
|
| 2003N-0017
|
| Risk Management Programs on the Practice of Pharmacy
|
|
|
| 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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|
|
| 2003P-0097
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| Unithroid as reference listed drug for levothyroxine sodium
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|
|
| 2003P-0171
|
| Amend the standard of identity for canned tomatoes.
|
|
|
| 2003P-0270
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| Prohibit False and Misleading Labeling
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|
|
| 2003P-0291
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| Enforce the law and prevent unlaw sale of contact lens
|
|
|
| 2003V-0396
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| Laser LIght Show
|
|
|
| 2003V-0426
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| Laser Light Show
|
|
|
| 1981N-0033P
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| Antiplaque & Antiplaque-Related Claims
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|
|
| NCR
1
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| FDA
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| Vol #:
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| 1
|
|
|
| 1986F-0208
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| MYCO-PROTEIN DERIVED FROM FUSARIUM GRANINEARUM SOURCE PRO
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|
|
| SUP
2
Attachment
1, 2, 3
|
| Center for Science in the Public Interest (CSPI)
|
| Vol #:
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| 1
|
|
|
| 1997P-0329
|
| Require Quantitative Labeling of Caffeine Content
|
|
|
| EMC 107
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| Taneia Brown
|
| Vol #:
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| 7
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|
|
| EMC 108
|
| Alaina Anderson
|
| Vol #:
|
| 7
|
|
|
| EMC 109
|
| Shakeena President
|
| Vol #:
|
| 107
|
|
|
| EMC 110
|
| Taneia Brown
|
| Vol #:
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| 7
|
|
| | | | | | | | |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
| LET
11215
|
| Arbonne International
|
| Vol #:
|
| 85
|
|
|
| LET
11216
|
| HVL Incorporated
|
| Vol #:
|
| 85
|
|
|
| LET
11217
|
| Market America, Inc.
|
| Vol #:
|
| 85
|
|
|
| LET
11218
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 85
|
|
|
| LET
11219
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 85
|
|
|
| LET
11220
|
| Interceuticals, Inc.
|
| Vol #:
|
| 85
|
|
|
| LET
11221
|
| Metagenics, Inc.
|
| Vol #:
|
| 85
|
|
|
| LET
11222
|
| Wellness International Network, Ltd.
|
| Vol #:
|
| 85
|
|
|
| LET
11223
|
| Enzymatic Therapy natural Medicines
|
| Vol #:
|
| 85
|
|
|
| LET
11224
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 85
|
|
|
| LET
11225
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 85
|
|
|
| LET
11226
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 85
|
|
|
| LET
11227
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 85
|
|
|
| LET
11228
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 85
|
|
|
| LET
11229
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 85
|
|
|
| LET
11230
|
| Doctor's Best, Inc.
|
| Vol #:
|
| 85
|
|
|
| LET
11231
|
| Ashbury Biologicals, Inc.
|
| Vol #:
|
| 85
|
|
|
| LET
11232
|
| Herbalife International of America, Inc.
|
| Vol #:
|
| 85
|
|
|
| LET
11233
|
| Wyeth Consumer Healthcare
|
| Vol #:
|
| 85
|
|
|
| LET
11234
|
| Wyeth Consumer Healthcare
|
| Vol #:
|
| 85
|
|
|
| LET
11235
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 85
|
|
|
| LET
11236
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 85
|
|
|
| LET
11237
|
| RKS Inc.
|
| Vol #:
|
| 85
|
|
|
| LET
11238
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 85
|
|
|
| LET
11239
|
| Vitamin Shoppe Industries Inc.
|
| Vol #:
|
| 85
|
|
|
| LET
11240
|
| Amerifit Nutrition
|
| Vol #:
|
| 85
|
|
|
| LET
11241
|
| Source Naturals
|
| Vol #:
|
| 85
|
|
|
| 1997V-0231
|
| Laser light show
|
|
|
| VRA
4
|
| HFZ-300 to Paramount Event Services, Inc.
|
| Vol #:
|
| 1
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
| C 7062
|
| Deborah Dakin
|
| Vol #:
|
| 301
|
|
|
| C 7063
|
| Dorothy Finger
|
| Vol #:
|
| 301
|
|
|
| C 7064
|
| Donna M. Johnson
|
| Vol #:
|
| 301
|
|
|
| C 7065
|
| Terry Maderak
|
| Vol #:
|
| 301
|
|
| | | | | | | |
|
|
| C 7066
|
| Jody L. Davis
|
| Vol #:
|
| 301
|
|
|
| C 7067
|
| Ignes Fatieous
|
| Vol #:
|
| 301
|
|
|
| C 7068
|
| Heinrich Schliemunn
|
| Vol #:
|
| 301
|
|
|
| C 7069
|
| Caption Connection
|
| Vol #:
|
| 301
|
|
|
| C 7070
|
| Denise Norris
|
| Vol #:
|
| 301
|
|
|
| C 7071
|
| Teri Kraslavsky
|
| Vol #:
|
| 301
|
|
|
| C 7072
|
| R. Bell
|
| Vol #:
|
| 301
|
|
|
| EMC 3692
|
| Dinda Evans
|
| Vol #:
|
| 281
|
|
|
| EMC 3693
|
| Lisa Hobson-Lee
|
| Vol #:
|
| 281
|
|
|
| EMC 3694
|
| Karen Bartell
|
| Vol #:
|
| 281
|
|
|
| EMC 3695
|
| Amanda Nelson
|
| Vol #:
|
| 281
|
|
|
| EMC 3696
|
| Mary Ann Rice
|
| Vol #:
|
| 281
|
|
|
| EMC 3697
|
| Darcel Oas
|
| Vol #:
|
| 281
|
|
|
| EMC 3698
|
| Darcel Oas
|
| Vol #:
|
| 281
|
|
|
| EMC 3699
|
| Darcel Oas
|
| Vol #:
|
| 281
|
|
|
| EMC 3700
|
| Elizabeth Ferrari
|
| Vol #:
|
| 281
|
|
|
| EMC 3701
|
| Leonard Karpen
|
| Vol #:
|
| 281
|
|
|
| EMC 3702
|
| Melissa Alford
|
| Vol #:
|
| 281
|
|
|
| EMC 3703
|
| Erin Baiano
|
| Vol #:
|
| 281
|
|
|
| EMC 3704
|
| Ronald Messina
|
| Vol #:
|
| 281
|
|
|
| EMC 3705
|
| Christine Pawlak
|
| Vol #:
|
| 281
|
|
|
| EMC 3706
|
| Michael Loveless
|
| Vol #:
|
| 281
|
|
|
| EMC 3707
|
| Patty Shenker
|
| Vol #:
|
| 281
|
|
|
| EMC 3708
|
| Linda Rader
|
| Vol #:
|
| 281
|
|
|
| EMC 3709
|
| Rachel Meltzer
|
| Vol #:
|
| 281
|
|
|
| EMC 3710
|
| Connie Garcia
|
| Vol #:
|
| 281
|
|
|
| EMC 3711
|
| Corrie Lenon
|
| Vol #:
|
| 281
|
|
|
| EMC 3712
|
| Dian Hardison
|
| Vol #:
|
| 281
|
|
|
| EMC 3713
|
| Carolina Amador
|
| Vol #:
|
| 281
|
|
|
| EMC 3714
|
| Heidi Liebwein
|
| Vol #:
|
| 281
|
|
|
| EMC 3715
|
| Lisa Candido
|
| Vol #:
|
| 281
|
|
|
| EMC 3716
|
| Nancy Gordon
|
| Vol #:
|
| 281
|
|
|
| EMC 3717
|
| Wendy Torr
|
| Vol #:
|
| 281
|
|
|
| EMC 3718
|
| Michele Greenstein
|
| Vol #:
|
| 281
|
|
|
| EMC 3719
|
| Lindsay Cooper
|
| Vol #:
|
| 281
|
|
|
| EMC 3720
|
| Suzanne Beck
|
| Vol #:
|
| 281
|
|
|
| EMC 3721
|
| Lisa Smith
|
| Vol #:
|
| 281
|
|
| | | | | | | |
|
|
| EMC 3722
|
| Wendi Swaffield
|
| Vol #:
|
| 281
|
|
|
| EMC 3723
|
| Robin Budry
|
| Vol #:
|
| 281
|
|
|
| EMC 3724
|
| Judy Reinhold
|
| Vol #:
|
| 281
|
|
|
| EMC 3725
|
| Virginia Lamarche
|
| Vol #:
|
| 281
|
|
|
| EMC 3726
|
| Patricia Mathis
|
| Vol #:
|
| 281
|
|
|
| EMC 3727
|
| Demetra Dritsopoulos
|
| Vol #:
|
| 281
|
|
|
| EMC 3728
|
| Cherie Cooper
|
| Vol #:
|
| 281
|
|
|
| EMC 3729
|
| Catherine Jarrett
|
| Vol #:
|
| 281
|
|
|
| EMC 3730
|
| Richard Jarrett
|
| Vol #:
|
| 281
|
|
|
| EMC 3731
|
| Shirley Gellis
|
| Vol #:
|
| 281
|
|
|
| EMC 3732
|
| Divonne Wald
|
| Vol #:
|
| 281
|
|
|
| EMC 3733
|
| Kelly Toole
|
| Vol #:
|
| 281
|
|
|
| EMC 3734
|
| Joan Fay
|
| Vol #:
|
| 281
|
|
|
| EMC 3735
|
| Marie Gansen
|
| Vol #:
|
| 281
|
|
|
| EMC 3736
|
| Karen Bova
|
| Vol #:
|
| 281
|
|
|
| EMC 3737
|
| Rosemary A. DaCunha
|
| Vol #:
|
| 281
|
|
|
| EMC 3738
|
| Ryan Anderson
|
| Vol #:
|
| 281
|
|
|
| EMC 3739
|
| Nancy Sherman
|
| Vol #:
|
| 281
|
|
|
| EMC 3740
|
| Dorean H. Wert
|
| Vol #:
|
| 281
|
|
|
| EMC 3741
|
| Scott & Donna Howard
|
| Vol #:
|
| 281
|
|
|
| EMC 3742
|
| Marilyn Ridley
|
| Vol #:
|
| 281
|
|
|
| EMC 3743
|
| John Dambra
|
| Vol #:
|
| 281
|
|
|
| EMC 3744
|
| Mary Kay Duffy
|
| Vol #:
|
| 281
|
|
|
| EMC 3745
|
| Janet Stone
|
| Vol #:
|
| 281
|
|
|
| EMC 3746
|
| Nanette Beno
|
| Vol #:
|
| 281
|
|
|
| EMC 3747
|
| Laurie Hurst
|
| Vol #:
|
| 281
|
|
|
| EMC 3748
|
| Lisa Swanson
|
| Vol #:
|
| 281
|
|
|
| EMC 3749
|
| Kelly Wright
|
| Vol #:
|
| 281
|
|
|
| EMC 3750
|
| Lisa Bailey
|
| Vol #:
|
| 281
|
|
|
| EMC 3751
|
| Judith D. Willsey
|
| Vol #:
|
| 281
|
|
|
| EMC 3752
|
| Rodney DeGreenia
|
| Vol #:
|
| 281
|
|
|
| EMC 3753
|
| Carol Williams
|
| Vol #:
|
| 281
|
|
|
| EMC 3754
|
| Courtney Lemmon
|
| Vol #:
|
| 281
|
|
|
| EMC 3755
|
| Carol Rowe
|
| Vol #:
|
| 281
|
|
|
| EMC 3756
|
| Susan Roth
|
| Vol #:
|
| 281
|
|
|
| EMC 3757
|
| Lorraine Hertel
|
| Vol #:
|
| 281
|
|
|
| EMC 3758
|
| Jennifer Mayhew
|
| Vol #:
|
| 281
|
|
| | | | | | | | |
|
|
| EMC 3759
|
| Donna Silverman
|
| Vol #:
|
| 281
|
|
|
| EMC 3760
|
| Hilary Downing
|
| Vol #:
|
| 281
|
|
|
| EMC 3761
|
| Carlos Campos
|
| Vol #:
|
| 281
|
|
|
| EMC 3762
|
| Pat Quinn
|
| Vol #:
|
| 281
|
|
|
| EMC 3763
|
| Casey Diment
|
| Vol #:
|
| 281
|
|
|
| EMC 3764
|
| Connie Garcia
|
| Vol #:
|
| 281
|
|
|
| EMC 3765
|
| Connie Garcia
|
| Vol #:
|
| 281
|
|
|
| EMC 3766
|
| George Sarkisian
|
| Vol #:
|
| 281
|
|
|
| EMC 3767
|
| Cecilia Stancell
|
| Vol #:
|
| 281
|
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
|
|
| EMC 4060
|
| Claire Menck
|
| Vol #:
|
| 514
|
|
|
| EMC 4061
|
| David Quintana
|
| Vol #:
|
| 514
|
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
|
|
| EMC 558
|
| Jodi Elliott
|
| Vol #:
|
| 32
|
|
|
| 2000N-1484
|
| Safety Reporting Requirements Human Drug/Biological Products
|
|
|
| C
10
|
| Air Products Healthcare
|
| Vol #:
|
| 3
|
|
|
| EMC
12
|
| Federation of American Hospitals (the Federation)
|
| Vol #:
|
| 3
|
|
|
| 2000P-0685
|
| Revise of Yogurt Standards
|
|
|
| C
10
|
| National Milk Producers Federation (NMPF)
|
| Vol #:
|
| 1
|
|
|
| EC 5
|
| van den Hoven, Martien
|
| Vol #:
|
| 1
|
|
|
| EC 6
|
| REPELIN, Laurent
|
| Vol #:
|
| 1
|
|
|
| EC 7
|
| Juarez, Samuel
|
| Vol #:
|
| 1
|
|
|
| EC 8
|
| Frye, Cary
|
| Vol #:
|
| 1
|
|
|
| EC 9
|
| Roggenbuck, Mark
|
| Vol #:
|
| 1
|
|
|
| 2000P-1275
|
| Health Claim: Vegetable oil sterol esters & coronary heart d
|
|
|
| C
25
Attachment
|
| Tufts-New England Medical Center
|
| Vol #:
|
| 22
|
|
|
| C
26
|
| McGill University
|
| Vol #:
|
| 22
|
|
|
| LET
8
Attachment
1, 2, 3
|
| Unilever United States, Inc.
|
| Vol #:
|
| 22
|
|
|
| 2000P-1276
|
| Health Claim: Plant stanol esters and heart disease
|
|
|
| C
28
Attachment
|
| Tufts University
|
| Vol #:
|
| 22
|
|
|
| C
29
|
| McGill University
|
| Vol #:
|
| 22
|
|
|
| LET
9
Attachment
1, 2, 3
|
| Unilever United States, Inc.
|
| Vol #:
|
| 22
|
|
|
| 2000V-1247
|
| Laser Light Show
|
|
| | | | | | | | |
|
|
| VRA
5
|
| HFZ-300 to Laser Wizardry
|
| Vol #:
|
| 1
|
|
|
| 2001D-0583
|
| Food Security Guidance
|
|
|
| EC 16
|
| Dai, David
|
| Vol #:
|
| 1
|
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
| EMC 1204
|
| K. Flynn-Wisch
|
| Vol #:
|
| 5
|
|
|
| 2002D-0324
|
| Bioengineered Plants for Use in Humans and Animals
|
|
|
| C 645
|
| Mary M. Mergenthal
|
| Vol #:
|
| 13
|
|
|
| 2003D-0060
|
| Part11, Electronic records, electronic signatures scope
|
|
|
| C
33
|
| Synthetic Organic Chemical Manufacturers Assn (SOCMA)
|
| Vol #:
|
| 3
|
|
|
| 2003D-0236
|
| Draft "Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis;" Availability
|
|
|
| EC 2
|
| Bianco, Celso
|
| Vol #:
|
| 1
|
|
|
| 2003D-0290
|
| Compounding of Drugs for Use in Animals Compliance Policy Guide
|
|
|
| EC 2
|
| Thomas, Pamela
|
| Vol #:
|
| 1
|
|
|
| 2003N-0017
|
| Risk Management Programs on the Practice of Pharmacy
|
|
|
| C
4
|
| American Society of Pain Management Nurses
|
| Vol #:
|
| 1
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
| C
2
|
| American Palm Oil Council (APOC)
|
| Vol #:
|
| 1
|
|
|
| EMC 30
|
| Kimberly Marsch
|
| Vol #:
|
| 1
|
|
|
| EMC 31
|
| Keith Kuhn
|
| Vol #:
|
| 1
|
|
|
| EMC 32
|
| No signature
|
| Vol #:
|
| 1
|
|
|
| EMC 33
|
| Perry Bruner
|
| Vol #:
|
| 1
|
|
|
| EMC 34
|
| John Warmbrodt
|
| Vol #:
|
| 1
|
|
|
| EMC 35
|
| Matthew G. Goossen
|
| Vol #:
|
| 1
|
|
|
| EMC 36
|
| John McGinn
|
| Vol #:
|
| 1
|
|
|
| EMC 37
|
| Elaine Dai
|
| Vol #:
|
| 1
|
|
|
| EMC 38
|
| Darleen R. Johnson and Bruce W. Johnson
|
| Vol #:
|
| 1
|
|
|
| EMC 39
|
| Kristen Ryan
|
| Vol #:
|
| 1
|
|
|
| EMC 40
|
| No signature
|
| Vol #:
|
| 1
|
|
|
| EMC 41
|
| Mark Donchek
|
| Vol #:
|
| 1
|
|
|
| EMC 42
|
| James Lawrence
|
| Vol #:
|
| 1
|
|
|
| EMC 43
|
| No signature
|
| Vol #:
|
| 1
|
|
|
| EMC 44
|
| Sandra Schneiderman
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| EMC 45
|
| Christopher Modell
|
| Vol #:
|
| 1
|
|
|
| EMC 46
|
| Neale Pearson
|
| Vol #:
|
| 1
|
|
|
| EMC 47
|
| No signature
|
| Vol #:
|
| 1
|
|
|
| EMC 48
|
| Stu Clark
|
| Vol #:
|
| 1
|
|
|
| EMC 49
|
| Brian
|
| Vol #:
|
| 1
|
|
|
| EMC 50
|
| Brenda WettengelLentz
|
| Vol #:
|
| 1
|
|
|
| EMC 51
|
| Brenda WettengelLentz
|
| Vol #:
|
| 1
|
|
|
| EMC 52
|
| Marie Jo Grazioli
|
| Vol #:
|
| 1
|
|
|
| 2003N-0211
|
| Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma
|
|
|
| EC 2
|
| Morgan-Gannon, Sally
|
| Vol #:
|
| 1
|
|
|
| EC 3
|
| Wilson, Kathleen
|
| Vol #:
|
| 1
|
|
|
| 2003N-0338
|
| Obesity
|
|
|
| EC 1
|
| Carter, Chris
|
| Vol #:
|
| 1
|
|
|
| EC 2
|
| Paskalides, Jean
|
| Vol #:
|
| 1
|
|
|
| EC 3
|
| Crouthamel, Sr., Thomas
|
| Vol #:
|
| 1
|
|
|
| EC 4
|
| Johnson, Douglas Johnson
|
| Vol #:
|
| 1
|
|
|
| EC 5
|
| Procopio, Joan
|
| Vol #:
|
| 1
|
|
|
| EC 6
|
| Walker, Sarah
|
| Vol #:
|
| 1
|
|
|
| M 2
|
| Commission of the Food and Drugs, HF-1
|
| Vol #:
|
| 1
|
|
|
| 2003P-0097
|
| Unithroid as reference listed drug for levothyroxine sodium
|
|
|
| LET
1
|
| HFD-001 to Pennie & Edmonds, LLP
|
| Vol #:
|
| 1
|
|
|
| 2003P-0171
|
| Amend the standard of identity for canned tomatoes.
|
|
|
| C
1
Attachment
|
| Sugar Association, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2003P-0270
|
| Prohibit False and Misleading Labeling
|
|
|
| C 30
|
| Eva Boesing
|
| Vol #:
|
| 1
|
|
|
| 2003P-0291
|
| Enforce the law and prevent unlaw sale of contact lens
|
|
|
| C 57
|
| Dr. Thomas Kemperas
|
| Vol #:
|
| 2
|
|
|
| C 58
|
| Eligible
|
| Vol #:
|
| 2
|
|
|
| 2003V-0396
|
| Laser LIght Show
|
|
|
| VRA
1
|
| HFZ-300 to Kaanapali Beach Hotel
|
| Vol #:
|
| 1
|
|
|
| 2003V-0426
|
| Laser Light Show
|
|
|
| VRA
1
|
| HFZ-300 to Celebration City
|
| Vol #:
|
| 1
|
|
|