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DOCKETS ENTERED on 3/4/03

Docket Number - Title

98N-1109 Mercury Compounds in Drugs and Food *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
01P-0298 Permit Use of Symbols on In-Vitro Diagnostic Labeling *
01P-0389 Revoke CPG 7383.003 for Class III 510(k) Devices Pre-amend *
02D-0468 Manufacture and Labeling of Raw Meat Foods *
02D-0509 Intl Conference on Harmonisation/M4 Common Technical Documen *
02N-0534 Medical Device User Fee and Modernization Act of 2002 *
02P-0089 Allow Electronic Labeling to Meet 201(m) of FD&C Act *
02P-0338 OTC sales, distribution all brands of hand-held doppler fet *
03N-0016 MedWatch: The FDA Medical Products Reporting Program *
03N-0038 Medical Device User Fee Cover Sheet;Form FDA 3601 *
03P-0082 Abbreviated New Drug Application (ANDA) for Ursodiol Oral *
03P-0083 ANDA suitability for carbamazepine tablets, 100mg, 300mg,400 *
80N-0280 Vaginal Contraceptive Drug Products for OTC Use

EC 112 Ms. Kay Layne Rogers Vol#: 14

EC 113 Miss Michelle Ott Vol#: 14

EC 114 Mrs. Jody Cronk Vol#: 14

EC 115 Ms. Robyn Thomlinson Vol#: 14

EC 116 Mrs. Laura Simonsen Vol#: 14

EC 117 Number Not Used Vol#: 14

EC 118 Mrs. Elizabeth Jackson Vol#: 14

EC 119 Miss Pixie Delight Vol#: 14

EC 120 Mrs. Rhonda Gover Vol#: 14

91N-0384 Nutrient Claims, Definitions of Terms, General Principles

EMC 1 Carol Harvey Vol#: 86

93D-0398 Microbiological Testing Antimicrobial Drug Residues in Foods

N 1 Vol#: 1

95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability

EMC 1 No signature Vol#: 297

EMC 2 Kathleen Albert Vol#: 297

EMC 3 Elizabeth Gregg Vol#: 297

EMC 4 Jill Lopez Vol#: 297

EMC 5 Lari Meyer Vol#: 297

EMC 6 Mark Smitka Vol#: 297

EMC 7 Mary Wendt Vol#: 297

EMC 8 Sally Blinn Vol#: 297

EMC 9 William E. Straw, MD Vol#: 297

EMC 10 Colleen Burke Vol#: 297

EMC 11 Chuck Grandgent Vol#: 297

EMC 12 Verl Sowder Vol#: 297

EMC 13 Scott Silbereis Vol#: 297

EMC 14 No signature Vol#: 297

EMC 15 Lyla Rigsby Vol#: 297

EMC 16 Kelle Lynch-Baldwin Vol#: 297

EMC 17 Jennifer Clancey Vol#: 297

EMC 18 Richard Scott Griffith Vol#: 297

EMC 19 David Gold Vol#: 297

EMC 20 No signature Vol#: 297

EMC 21 Kathy Williamson Vol#: 297

EMC 22 Robert W. Huber Vol#: 297

EMC 23 No signature Vol#: 297

EMC 24 Cynthia Zeckmeister Vol#: 297

EMC 25 Gail Sharry Vol#: 297

EMC 26 Robert Dennin Vol#: 297

EMC 27 Jennifer M. Grubb Vol#: 297

EMC 28 Sally Arnet Vol#: 297

EMC 29 No signature Vol#: 297

EMC 30 No signature Vol#: 297

EMC 31 Daphna Abel Vol#: 297

EMC 32 Jan Gardner Vol#: 297

EMC 33 Kristen Fields Vol#: 297

EMC 34 Margaret Brearley Vol#: 297

EMC 35 David Berger, MD Vol#: 297

EMC 36 Jeff Lacher Vol#: 297

EMC 37 Rhea Schneiders Vol#: 297

EMC 38 Denise Valure Vol#: 297

EMC 39 Gina Vol#: 297

EMC 40 Eric Carlino Vol#: 297

EMC 41 Sheila McEnany Vol#: 297

EMC 42 Bonnie McKnew Vol#: 297

EMC 43 Shannon Fry Vol#: 297

EMC 44 Donna VanDamme Vol#: 297

EMC 45 John Boatner, MCSD Vol#: 297

EMC 46 Rose Newburg Vol#: 297

EMC 47 Don Taylor Vol#: 297

EMC 48 Bev Vol#: 297

EMC 49 Mary Tobin Vol#: 297

EMC 50 Mafmudije Selimi Vol#: 297

EMC 51 Mafmudije Selimi Vol#: 297

EMC 52 James Jobe Vol#: 297

EMC 53 Patricia M. Squicciarini Vol#: 297

EMC 54 Joseph C. Holden Jr. Vol#: 297

EMC 55 Chris Cunningham Vol#: 297

EMC 56 Rebecca S. Brown Vol#: 297

EMC 57 Kristina Abadie Vol#: 297

EMC 58 Wendy Gutreuter Vol#: 297

EMC 59 Chris Morris Vol#: 297

EMC 60 Joanne Snyder Vol#: 297

EMC 61 Susan Mandell Vol#: 297

96P-0500 Amend "Healthy" Definition re: Sodium Levels

EMC 1 Carol Harvey Vol#: 10

97N-0449 Revisions to General Safety Requirements for Biological Prod

NFR 2 Vol#: 1

98D-1146 Microbial effects of antimicrobial new animal drugs/human sa

EMC 669 Anita Frances Vol#: 19

EMC 670 June Crow Vol#: 19

98N-1109 Mercury Compounds in Drugs and Food

EMC 1 Watson Laboratories, Inc. Vol#: 2

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

C 6285 Ms. Diane Ashley Vol#: 272

C 6286 Marjorie Nelson Vol#: 272

C 6287 Kathy Philips Vol#: 272

C 6288 Barbara Schneider Vol#: 272

C 6289 George & Myra Hurst Vol#: 272

C 6290 S. Stenberg Vol#: 272

C 6291 D. D. F. Vol#: 272

C 6292 Heather Weiss Vol#: 272

C 6293 Ms Kimberly Moses Vol#: 272

C 6294 Bernice Dobrosz Vol#: 272

C 6295 Shannon Burroughs Vol#: 272

C 6296 Debbie Tico Vol#: 272

C 6297 Celia McKenzie Vol#: 272

C 6298 Evelyn V. Knazek Vol#: 272

C 6299 Giovanna Auzelone Vol#: 272

C 6300 Ms. Donna Foreman Vol#: 272

C 6301 Mrs. Shirley M. Cole Vol#: 272

C 6302 Leslie Hepburn Vol#: 272

C 6303 Elvira Pozvelos Vol#: 272

C 6304 Bruce & Marilyn Foote Vol#: 272

C 6305 Kristine C. Szabo Vol#: 272

C 6306 Julie Crimmins Vol#: 272

C 6307 Adrian Rahardja Vol#: 272

C 6308 Michelle Uting & Miguel Vallejo Vol#: 272

C 6309 Melanie Dancy Vol#: 272

C 6310 Ann K. Brown Vol#: 272

C 6311 Deborah Lyons Vol#: 272

C 6312 Theresa M. Bock Vol#: 272

C 6313 Tina Constantino Vol#: 272

C 6314 Bonnie J. Moxley Vol#: 272

C 6315 Wynne Jackson Vol#: 272

C 6316 Nancy Franz Vol#: 272

C 6317 Mary Archer Vol#: 272

C 6318 Kerry Kilmer Vol#: 272

C 6319 Pamela L. Ross Vol#: 272

C 6320 Alliance Against Animal Abuse Vol#: 272

C 6321 Robert Dunavant Vol#: 272

C 6322 Helen Albert Vol#: 272

C 6323 N. Lawrence Vol#: 272

C 6324 Valerie Stone Vol#: 272

C 6325 Susan R. Ward Vol#: 272

98P-0610 Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC

EMC 77 Niger Innis Vol#: 4

99F-4372 National Fisheries Institute and the Louisiana Dep of Agricu

EMC 423 Charles Benner Vol#: 7

99F-5321 Food Safety & Inspection service safe use of ionizing radiai

EMC 326 Charles Benner Vol#: 7

99F-5322 Ionizing Radiation for the Treatment of Food

EMC 325 Charles Benner Vol#: 5

99F-5522 Ionizing radiation /control of Food-borne pathogens safe use

EMC 328 Charles Benner Vol#: 5

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

EMC 3942 Maggie Matthews Vol#: 513

EMC 3943 Lisa McBride Vol#: 513

EMC 3944 Diane Hokans Vol#: 513

EMC 3945 Lisa Romano Vol#: 513

EMC 3946 Ellen Parry Tyler Vol#: 513

EMC 3947 Rev Rosa Redtail Vol#: 513

EMC 3948 Jacquie Roecker Vol#: 513

EMC 3949 Thomas O'Grady Vol#: 513

EMC 3950 Dennis Heinzig Vol#: 513

EMC 3951 Fletcher Glancy Vol#: 513

EMC 3952 Robin Weinrich Vol#: 513

99P-1340 Declared Eternity eau de Parfum Misbranded

EMC 430 Husain Kagolo Vol#: 21

EMC 431 Matt Helton Vol#: 21

00P-1322 Food Labeling and Allergen Contamination Control

EMC 494 Donald A. Belt, PhD Vol#: 20

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

EMC 429 Charles Benner Vol#: 7

01P-0298 Permit Use of Symbols on In-Vitro Diagnostic Labeling

LET 1 HFZ-1 to Bio-Rad Laboratories Vol#: 1

01P-0389 Revoke CPG 7383.003 for Class III 510(k) Devices Pre-amend

PDN 1 HF-22 to Kyper & Associates LLC Vol#: 1

02D-0303 Guidance for Industry on Formal Dispute Resolution

NAL 1 Vol#: 1

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

EMC 87 Annie Phillips Vol#: 3

EMC 88 D. Taylor Remond Vol#: 3

EMC 89 M. Korn Vol#: 3

EMC 90 Monica Contreras Gernentz Vol#: 3

EMC 91 Meghan Rourke Vol#: 3

EMC 92 Number Not Used Vol#: 3

EMC 93 Judith Szabo Vol#: 3

EMC 94 Marci Ginder Vol#: 3

EMC 95 Mattisa Dumas Vol#: 3

EMC 96 Jeri Kendall Vol#: 3

EMC 97 Sharlya Gold Vol#: 3

02D-0385 Approval of Labeling for Foods Treated by Irradiation

EC 12 Me Vol#: 1

02D-0468 Manufacture and Labeling of Raw Meat Foods

EC 16 The Fund for Animals Vol#: 1

EC 17 Mr. Scott Harris Vol#: 1

EC 18 Little Big Cat, Inc. Vol#: 1

EMC 5 Dale Lawson Vol#: 1

02D-0509 Intl Conference on Harmonisation/M4 Common Technical Documen

EC 1 Hurley Consulting Associates Ltd. Vol#: 1

02F-0160 Safe use of Vitamin D3 in Calcium-Fortified Fruit Juices

EC 1 Ms. JoAnn Siegfried Vol#: 1

02N-0276 Bioterrorism Preparedness;Registration of Food Facilities

EC 58 Number Not Used Vol#: 7

EC 59 ENTEGRE GIDA SANAYI AS Vol#: 7

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

EC 60 LIMAPRO DISTRIBUTEURS INC. Vol#: 7

EC 61 Sun America Imports Vol#: 7

EC 62 Olde York Potato Chips Vol#: 7

02N-0534 Medical Device User Fee and Modernization Act of 2002

EMC 1 Henry Schein, Inc. Vol#: 1

02P-0089 Allow Electronic Labeling to Meet 201(m) of FD&C Act

LET 1 HFZ-1 to St. Jude Medical Vol#: 1

02P-0317 Recall Aspartame as a Neurotoxic Drug

EMC 236 Betty Martini Vol#: 5

02P-0338 OTC sales, distribution all brands of hand-held doppler fet

LET 1 HFZ-1 to Russel J. Thomsen, M.D. Vol#: 1

03D-0060 Part11, Electronic records, electronic signatures scope

EMC 1 TDV, SL Vol#: 1

03N-0016 MedWatch: The FDA Medical Products Reporting Program

EMC 1 Dentsply International Inc. Vol#: 1

03N-0034 FDA Safety Alert/ Public Health Advisory Readership Survey

EC 2 Ms. Daphna Abel Vol#: 1

03N-0038 Medical Device User Fee Cover Sheet;Form FDA 3601

EC 1 Criticare Systems, Inc. Vol#: 1

03N-0059 Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach

EC 1 F.A.M.E. Systems Vol#: 1

EC 2 F.A.M.E. Systems Vol#: 1

EC 3 Mrs. SUSAN LOHSE Vol#: 1

EC 4 Mrs. Patricia Rishebarger Vol#: 1

EC 5 none Vol#: 1

03N-0068 Beverages: Bottled Water

EC 1 Mr. Nathan Steele Vol#: 1

NFR 1 Vol#: 1

NPR 1 Vol#: 1

03P-0082 Abbreviated New Drug Application (ANDA) for Ursodiol Oral

ACK 1 HFA-305 to Lachman Consultant Services Vol#: 1

CP 1 Lachman Consultant Services, Inc. Vol#: 1

03P-0083 ANDA suitability for carbamazepine tablets, 100mg, 300mg,400

ACK 1 HFA-305 Vol#: 1

CP 1 Taro Pharmaceuticals, U.S.A., Inc. Vol#: 1