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Dockets Management
Dockets Entered On October 9, 2003
Table of Contents
Docket # Title
1981N-0033P Antiplaque & Antiplaque-Related Claims
1986F-0208 MYCO-PROTEIN DERIVED FROM FUSARIUM GRANINEARUM SOURCE PRO
1997P-0329 Require Quantitative Labeling of Caffeine Content
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1997V-0231 Laser light show
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
1999N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings
1999P-2630 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 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2003N-0338 Obesity
2003P-0097 Unithroid as reference listed drug for levothyroxine sodium
2003P-0171 Amend the standard of identity for canned tomatoes.
2003P-0270 Prohibit False and Misleading Labeling
2003P-0291 Enforce the law and prevent unlaw sale of contact lens
2003V-0396 Laser LIght Show
2003V-0426 Laser Light Show
1981N-0033P Antiplaque & Antiplaque-Related Claims
NCR 1 FDA Vol #: 1
1986F-0208 MYCO-PROTEIN DERIVED FROM FUSARIUM GRANINEARUM SOURCE PRO
SUP 2
Attachment 1, 2, 3
Center for Science in the Public Interest (CSPI) Vol #: 1
1997P-0329 Require Quantitative Labeling of Caffeine Content
EMC 107 Taneia Brown Vol #: 7
EMC 108 Alaina Anderson Vol #: 7
EMC 109 Shakeena President Vol #: 107
EMC 110 Taneia Brown Vol #: 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

Page created 10/15/03
Page updated October 22, 2003 jb

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