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DOCKETS ENTERED on 2/5/03

Docket Number - Title

75N-183H Health-Care Antiseptic Drug Products for OTC Human Use *
80N-0280 Vaginal Contraceptive Drug Products for OTC Use *
94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims *
95S-0316 75-Day Premarket Notifications for New Dietary Ingredients *
96D-0041 Clinical Safety Data Management: Safety Update Reports *
02D-0324 Bioengineered Plants for Use in Humans and Animals *
02N-0209 Governing First Amendment Case Law *
02N-0273 Animal Proteins Prohibited in Ruminant Feed *
02P-0474 ANADA for tiamulin soluble powder tiamulin hydrogen fumarate *
02P-0505 Labeling nuts & eligible nut containing products reduce risk *
75N-183H Health-Care Antiseptic Drug Products for OTC Human Use

LET 36 BioScience Laboratories, Inc. Vol#: 149

80N-0042 Anticaries Drug Products for OTC Human Use

ACK 16 HFA-305 Vol#: 36

80N-0208 BIOLOGICAL PRODUCTS; BACTERIAL VACCINES AND TOXIODS

BKG 1 BACKGROUND Vol#: 2

BKG 2 BACKGROUND Vol#: 3

80N-0280 Vaginal Contraceptive Drug Products for OTC Use

EC 59 Mrs. Barbara H Baskin Vol#: 14

EC 60 Ms. LaDonna Snyder Vol#: 14

EC 61 Montclair State University (Adjunct Prof Vol#: 14

EC 62 Ms. Chaprie Robinson Vol#: 14

EC 63 Ms. Marjorie White Vol#: 14

EC 64 Ms. Cassandra Nugent Vol#: 14

EC 65 Villaume Industries, Inc. Vol#: 14

EC 66 Ms. Jillian Voss Vol#: 14

EC 67 Ms. Lindsay Marsico Vol#: 14

EC 68 Mrs. Sharon Luedtke Vol#: 14

EC 69 Ms. Karina Martinez Vol#: 14

EC 70 Ms. Judith Brown Vol#: 14

EC 71 Ms. Nacole Pipher Vol#: 14

EC 72 Miss C S Vol#: 14

EC 73 Miss Pamela Perry Vol#: 14

EC 74 Ms. T Hammer Vol#: 14

EC 75 Ms. Frances Forde Vol#: 14

EC 76 Mrs. Tina Hall-McClain Vol#: 14

EC 77 The Orme School Vol#: 14

EC 78 Black Students in Health Association, U Vol#: 14

EC 79 Mrs. Aimee Rhea Vol#: 14

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

C 2299 International Food Information Council Vol#: 68

EMC 547 Tracy Robertson Vol#: 68

95S-0316 75-Day Premarket Notifications for New Dietary Ingredients

RPT 131 Neptune Technologies & Bioressources Vol#: 93

RPT 132 Neptune Technologies & Bioressources Vol#: 94

RPT 133 Neptune Technologies & Bioressources Vol#: 95

RPT 134 Lonza, Inc. Vol#: 96

96D-0041 Clinical Safety Data Management: Safety Update Reports

EMC 2 Pharmacia Vol#: 1

98P-0151 Introduction Of Downed Cattle Into The Food Supply

EMC 3060 Patricia Conway Vol#: 265

EMC 3061 Linda Benninghoff Vol#: 265

EMC 3062 Sylvia Hamersley Vol#: 265

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

EMC 3924 Joshua Lubarr Vol#: 513

EMC 3925 Cathy McGowan Vol#: 513

EMC 3926 Cathy McGowan Vol#: 513

EMC 3927 Heidi Dean Vol#: 513

EMC 3928 Alissa Zimman Vol#: 513

EMC 3929 Amanda Abarbanel-Rice Vol#: 513

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

EMC 897 Nancy Onque Vol#: 217

99P-1340 Declared Eternity eau de Parfum Misbranded

EMC 425 Joan Webb Vol#: 21

99P-2630 Establish a Daily Value for "added sugars"

EMC 476 Arlene Duff Vol#: 32

00D-1540 Electronic Signatures, Electronic Copies of Electronic Recor

BKG 1 BACKGROUND MATERIAL Vol#: 6

NWL 1 Vol#: 6

00D-1598 Voluntary Labeling for Bioengineered Foods

EMC 11884 Carrie F. Knox Vol#: 574

EMC 11885 Neal Graham Vol#: 574

EMC 11886 Gabriella Turek Vol#: 574

EMC 11887 Gabriella Turek Vol#: 574

EMC 11888 Clyde Everton Vol#: 574

EMC 11889 Charles McCollum Vol#: 574

EMC 11890 Nicole Person Vol#: 574

EMC 11891 Wanda Ballentine Vol#: 574

EMC 11892 Chuck Pliske Vol#: 574

EMC 11893 Jim & Virginia Wagner Vol#: 574

EMC 11894 Maria Harrington Vol#: 574

EMC 11895 Daniel Lock Vol#: 574

EMC 11896 William Affleck-Asch Vol#: 574

EMC 11897 Connie Lippert Vol#: 574

EMC 11898 Charles Guenther Vol#: 574

EMC 11899 Margaret Gilleo Vol#: 574

EMC 11900 Donna Hoaglin Vol#: 574

EMC 11901 Joseph Sventek Vol#: 574

EMC 11902 Robert Anderson Vol#: 574

EMC 11903 James Toth Vol#: 574

EMC 11904 Joseph Lemieux Vol#: 574

EMC 11905 Jennifer Pennell Vol#: 574

EMC 11906 Marla Allen Vol#: 574

EMC 11907 Joan Friedland Vol#: 574

EMC 11908 David Banner Vol#: 574

EMC 11909 Pamela Pinto Vol#: 574

EMC 11910 Janet Elsbach Vol#: 574

EMC 11911 Doug Mattingly Vol#: 574

EMC 11912 E.M.T. O'Nan Vol#: 574

EMC 11913 Herve Le Meur Vol#: 574

EMC 11914 Denise Trimble Vol#: 574

EMC 11915 Peggy Evans Vol#: 574

EMC 11916 Kris Marohn Vol#: 574

EMC 11917 Andrea Azuma Vol#: 574

EMC 11918 Danielle Wirth Vol#: 574

EMC 11919 Anna Moomaw Vol#: 574

EMC 11920 Norm Self Vol#: 574

EMC 11921 Norm Self Vol#: 574

EMC 11922 Gillian Dale Vol#: 574

EMC 11923 Cheryl Coate Vol#: 574

EMC 11924 Maureen Langberg Vol#: 574

EMC 11925 Amanda Saxton Vol#: 574

EMC 11926 Deana Apfel Vol#: 574

EMC 11927 Donna Hoaglin Vol#: 574

EMC 11928 Diane Pecot Vol#: 574

EMC 11929 Gail Harmon Vol#: 574

EMC 11930 Clyde Everton Vol#: 574

EMC 11931 Bill Stern Vol#: 574

EMC 11932 Nancy Idstein Vol#: 574

EMC 11933 Joanna Markessinis Vol#: 574

EMC 11934 Virginia Jones Vol#: 574

EMC 11935 Sara Smith Vol#: 574

EMC 11936 Bobbe Besold Vol#: 574

EMC 11937 Linda Moorcock Vol#: 574

EMC 11938 Edward Oberste Vol#: 574

EMC 11939 Edward Oberste Vol#: 574

EMC 11940 Michael Steen Vol#: 574

EMC 11941 Michael Steen Vol#: 574

EMC 11942 Dale Figtree Vol#: 574

EMC 11943 Dale Figtree Vol#: 574

EMC 11944 Stacy Miller Vol#: 574

EMC 11945 Hristo Stoynov Vol#: 574

EMC 11946 Rosa Silver Vol#: 574

EMC 11947 Rosa Silver Vol#: 574

EMC 11948 Linda Ward Vol#: 574

EMC 11949 Linda Ward Vol#: 574

EMC 11950 Linda Anne Nisbet Vol#: 574

EMC 11951 Linda Anne Nisbet Vol#: 574

EMC 11952 John Newcomb Vol#: 574

EMC 11953 John Newcomb Vol#: 574

EMC 11954 Norah Renken Vol#: 574

EMC 11955 Norah Renken Vol#: 574

EMC 11956 Thelma Meyer Vol#: 574

EMC 11957 Thelma Meyer Vol#: 574

EMC 11958 Tor Chantara Vol#: 574

EMC 11959 Tor Chantara Vol#: 574

EMC 11960 John Mazurek Vol#: 574

EMC 11961 John Mazurek Vol#: 574

EMC 11962 John Mazurek Vol#: 574

EMC 11963 Tom Frazier Vol#: 574

EMC 11964 Tom Frazier Vol#: 574

EMC 11965 Jonathan Cender Vol#: 574

EMC 11966 Jonathan Cender Vol#: 574

EMC 11967 Robert M. Lowen, MD Vol#: 574

EMC 11968 Robert M. Lowen, MD Vol#: 574

EMC 11969 Rosalind Reine Vol#: 574

EMC 11970 Rosalind Reine Vol#: 574

EMC 11971 Peg Tischler Vol#: 574

EMC 11972 Jennifer Mollett Vol#: 574

EMC 11973 Stephanie Taylor Vol#: 574

EMC 11974 Sharon Pleas Vol#: 574

EMC 11975 Gayle Sullivan Vol#: 574

EMC 11976 Lori Tierey Vol#: 574

EMC 11977 Carole Ninemires Vol#: 574

EMC 11978 Paul Sanchez-Navarro Vol#: 574

EMC 11979 Jan Bolan Vol#: 574

EMC 11980 Judith Simonson Vol#: 574

EMC 11981 Diane Valletta Vol#: 574

EMC 11982 Liane Casten Vol#: 574

EMC 11983 Donna Noonan Vol#: 574

EMC 11984 Artemio Paz Vol#: 574

EMC 11985 John J. Gishnock, III Vol#: 574

EMC 11986 Tom Taylor Vol#: 574

EMC 11987 Indigo Crone Vol#: 574

EMC 11988 Kathe Sandstrom Vol#: 574

EMC 11989 Charles Sanders Vol#: 574

EMC 11990 Debra Hayes Vol#: 574

EMC 11991 Ann King (Fenner) Vol#: 574

EMC 11992 Jeremy Brown Vol#: 574

EMC 11993 Curtis Ryan Vol#: 574

EMC 11994 N. Renee Elbaum Vol#: 574

EMC 11995 Sigrid Vogelpohl, LMT Vol#: 574

EMC 11996 Scott Haydon Vol#: 574

EMC 11997 P. Desmond Keyes Vol#: 574

EMC 11998 Lori Rebman Vol#: 574

EMC 11999 Rebecca Carley Vol#: 574

EMC 12000 May Jo Walters Vol#: 574

EMC 12001 Gary Bowers Vol#: 574

EMC 12002 Paul Mosley Vol#: 574

EMC 12003 Marc VanAllen Vol#: 574

01F-0047 Foodborne pathogens in raw-frozen-cooked-partially cooked

EMC 425 Joshua Lubarr Vol#: 6

EMC 426 Cathy McGowan Vol#: 6

EMC 427 Cathy McGowan Vol#: 6

EMC 428 Heidi Dean Vol#: 6

01P-0230 Domestic Marketing & Importation of Transgenic Fish

EMC 2664 Sandra Bellinger Vol#: 228

EMC 2665 Erik Berg Vol#: 228

EMC 2666 Helen C. Housden (UK) Vol#: 228

EMC 2667 Lorna Crosby Vol#: 228

01P-0345 Listing the color additive yellow #5 for use in food/Drug

EMC 1161 Brad & Jill Ransom Vol#: 5

02D-0324 Bioengineered Plants for Use in Humans and Animals

C 582 Montana State University Vol#: 12

EMC 6 James Traynor Vol#: 12

EMC 7 Liisa Wale Vol#: 12

EMC 8 Jennifer K. Allbritton Vol#: 12

EMC 9 Stayce Zimbleman Vol#: 12

EMC 10 Patrick West Vol#: 12

02D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate

EMC 70 Mary Bradley Vol#: 3

EMC 71 Nicole Vlach Vol#: 3

EMC 72 Meaghan Bailey Vol#: 3

EMC 73 Patricia Epps Vol#: 3

EMC 74 Al Seyler Vol#: 3

EMC 75 Margie R. Walker Vol#: 3

EMC 76 Ann Calverley Vol#: 3

EMC 77 Carie Hess Vol#: 3

EMC 78 No signature Vol#: 3

EMC 79 Lisa Poisso Vol#: 3

EMC 80 Jan Milburn Vol#: 3

EMC 81 Jennifer C. Watkins Vol#: 3

02N-0209 Governing First Amendment Case Law

C 104 Tropicana Products, Inc. Vol#: 19

EMC 226 Anthony White Vol#: 25

02N-0273 Animal Proteins Prohibited in Ruminant Feed

C 28 Darling International Inc. Vol#: 2

C 29 Pet Food Institute Vol#: 2

C 30 North American Rendering Industry Vol#: 2

C 31 American Meat Institute (AMI) Vol#: 2

EC 18 self and many others Vol#: 2

EC 19 mother of three Vol#: 2

EC 20 myself Vol#: 2

EC 21 Fats and Proteins Research Foundation Vol#: 2

EC 22 Fats and Proteins Research Foundation Vol#: 2

EMC 4 Terry S. Singeltary Sr. Vol#: 2

EMC 5 Dept of Agriculture of Australia Vol#: 2

EMC 6 American Meat Institute (AMI) Vol#: 2

EMC 7 Ohio Dept. of Agriculture Vol#: 2

EMC 8 Federation of Animal Science Societies Vol#: 2

EMC 9 Food Animal Concerns Trust (FACT) Vol#: 2

EMC 10 Florida Dept of Agriculture & Consumer S Vol#: 2

02N-0276 Bioterrorism Preparedness;Registration of Food Facilities

EC 35 Premier Logistics Inc. Vol#: 3

EC 36 Mr. Thomas Fossey Vol#: 3

EC 37 Abbott Blackstone Co. Vol#: 3

EMC 13 Edward J. Kleinwort Vol#: 3

02N-0278 Bioterrorism; Prior Notice of Imported Food Shipments

EC 37 Affiliated Customs Brokers Vol#: 3

EC 38 Ricardo Gonzalez Customs Broker Vol#: 3

EC 39 Trinidad Dock and Fishing Services, Ltd. Vol#: 3

EC 40 Abbott Blackstone Co. Vol#: 3

EC 41 Britton & Company Vol#: 3

EC 42 STOLT-NIELSEN TRANSPORTATION GROUP Vol#: 3

EC 43 Flagship Customs Services Inc. Vol#: 3

EMC 12 Jessica M. Novak Vol#: 3

02P-0317 Recall Aspartame as a Neurotoxic Drug

EMC 232 Ruth Bulot Vol#: 5

EMC 233 Wendy Slater Vol#: 5

02P-0474 ANADA for tiamulin soluble powder tiamulin hydrogen fumarate

WDL 1 Phoenix Scientific, Inc. Vol#: 1

02P-0505 Labeling nuts & eligible nut containing products reduce risk

LET 2 Harvard School of Public Health Vol#: 4

03M-0040 PMA INDERMIL Tissue Adhesive, P010002

AAV 1 United States Surgical Corporation Vol#: 1

03M-0045 PMA, Stockert 70 RF Generator for Cardiac Ablation, P990071

AAV 1 Biosense Webster, Inc. Vol#: 1

03M-0046 pma Dimension FPSA Flex Reagent Cartridge & Dimension T/F PS

AAV 1 Dade Behring, Inc. Vol#: 1

03N-0009 Federal Preemption of State & Local Medical Device Requireme

EC 1 Ms. WENDY BROOKS Vol#: 1