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DOCKETS ENTERED on 3/12/03

Docket Number - Title

95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability *
96N-0417 CGMP in Packing or Holding Dietary Supplements *
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa *
00N-1571 Enrofloxacin for Poultry: Opportunity for Hearing *
00P-1199 Approval of ANDAs for Extended-Release *
02D-0492 Clinical Trials for Therapeutics in Adult Healthy Volunteers *
02F-0160 Safe use of Vitamin D3 in Calcium-Fortified Fruit Juices *
0N-0528 Risk Management Workshop, April 9-11, 2003 [PDUFA III] *
02P-0001 Curb Abuses by Sponsors of ANDAs *
02P-0285 Combination oxycodone hydrochloride/acetaminophen tablet * 95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability

EMC 74 Rebecca Brockman Vol#: 297

EMC 75 Clara Adams Vol#: 297

EMC 76 Carrie Vol#: 297

EMC 77 Sheila A. Bogner Vol#: 297

EMC 78 Henk Mutsaers Vol#: 297

EMC 79 Carolyn Smith Vol#: 297

EMC 80 Paulien Hemelaar Vol#: 297

EMC 81 Nancy Teresi Vol#: 297

EMC 82 Paulien Hemelaar Vol#: 297

EMC 83 Tom Switzer Vol#: 297

EMC 84 No signature Vol#: 297

EMC 85 Sally Rappeport Vol#: 297

EMC 86 St. James Natural Food Vol#: 297

EMC 87 Emilee Curtis Vol#: 297

EMC 88 Bonnie Kloepfer Vol#: 297

EMC 89 Mariann Le Vol#: 297

EMC 90 Dr. Jonathan Selzer Vol#: 297

EMC 91 Stan Zaske Vol#: 297

EMC 92 Doyle Blumer Vol#: 297

96N-0417 CGMP in Packing or Holding Dietary Supplements

EMC 2 National Organization for Rare Disorders Vol#: 7

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

EMC 671 National Aquaculture Assn Vol#: 19

EMC 672 Gayla Ivey Vol#: 19

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

C 6374 Seana Parker Vol#: 273

C 6375 Stacy Lybrand Vol#: 273

C 6376 Ms. Heather M. Dailide Vol#: 273

C 6377 A. Morco Masonis Vol#: 273

C 6378 Irene B. Hayes Vol#: 273

C 6379 Marcia Bradley Vol#: 273

C 6380 Edna B. Kimball Vol#: 273

C 6381 no signature Vol#: 273

C 6382 Marianne Naufel Vol#: 273

C 6383 Timothy & Allison Harman Vol#: 273

C 6384 Cynthia J. Breen Vogel Vol#: 273

C 6385 Tracy J. Quellette, M.D. Vol#: 273

C 6386 B. Griffin Vol#: 273

C 6387 Richard & Beverly Suire Vol#: 273

C 6388 Mrs. Dolores Curl Vol#: 273

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

EMC 425 L. Stille Vol#: 7

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

EMC 328 L. Stille Vol#: 7

99F-5322 Ionizing Radiation for the Treatment of Food

EMC 327 L. Stille Vol#: 5

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

EMC 330 L. Stille Vol#: 5

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

EMC 3954 Amy Porto Vol#: 513

EMC 3955 David De A'Morelli Vol#: 513

EMC 3956 Baali Nato Vol#: 513

EMC 3957 Elizabeth Rectenwald Vol#: 513

EMC 3958 Robert John Hogge Vol#: 513

EMC 3959 Jan MacLaughlin Vol#: 513

EMC 3960 Tara Seitz Vol#: 513

99P-1340 Declared Eternity eau de Parfum Misbranded

EMC 432 Mary Lamber Vol#: 21

99P-4613 Revoke the Regulation That Approved Posilac

EMC 2419 Laura Zimmerman Vol#: 46

00N-1571 Enrofloxacin for Poultry: Opportunity for Hearing

CS 30 HFA-305 Vol#: 359

OR 32 HF-3 Vol#: 359

00P-1199 Approval of ANDAs for Extended-Release

WDL 1 Biovail Corporation Vol#: 1

00P-1322 Food Labeling and Allergen Contamination Control

EMC 495 Kathy Smith Vol#: 20

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

EMC 431 L. Stille Vol#: 7

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

EMC 1164 No signature Vol#: 5

EMC 1165 John Mechikoff Vol#: 5

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

EMC 101 Anne Tindell Vol#: 3

EMC 102 Linda Choo Vol#: 3

EMC 103 Clara Staton Vol#: 3

EMC 104 Barbara Klein Vol#: 3

02D-0492 Clinical Trials for Therapeutics in Adult Healthy Volunteers

C 4 PhRMA Vol#: 1

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

EXT 1 Dairy Management, Inc. (DMI) Vol#: 1

02N-0276 Bioterrorism Preparedness;Registration of Food Facilities

C 34 Society of the Plastics Industry, Inc. Vol#: 7

C 35 Hansen-Mueller Company Vol#: 7

C 36 American Frozen Food Institute (AFFI) Vol#: 7

C 37 Northland Cranberries, Inc. Vol#: 7

MM 8 Summary of Outreach Meeting 02/06/03 Vol#: 7

MM 9 Summary of Outreach Meeting 02/04/03 Vol#: 7

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

C 38 Society of the Plastics Industry, Inc. Vol#: 7

C 39 Hansen-Mueller Company Vol#: 7

C 40 Nat'l Coalition of Food Importing Assn Vol#: 7

C 41 National Fisheries Institute Vol#: 7

C 42 American Frozen Food Institute (AFFI) Vol#: 7

C 43 Northland Cranberries, Inc. Vol#: 7

C 44 Williams Clarke Company, Inc. Vol#: 7

EMC 15 FedEx Trade Networks Vol#: 7

MM 8 Summary of Outreach Meeting 02/06/03 Vol#: 7

MM 9 Summary of Outreach Meeting 02/04/03 Vol#: 7

0N-0528 Risk Management Workshop, April 9-11, 2003 [PDUFA III]

EMC 1 Opt-e-scrip, Inc. Vol#: 1

02P-0001 Curb Abuses by Sponsors of ANDAs

WDL 1 Biovail Corporation Vol#: 1

02P-0285 Combination oxycodone hydrochloride/acetaminophen tablet

ACK 2 HFA-305 to King & Spalding LLP Vol#: 1

PRC 1 King & Spalding LLP Vol#: 1

02P-0317 Recall Aspartame as a Neurotoxic Drug

EMC 238 Betty Martini Vol#: 5

EMC 239 Betty Martini Vol#: 5

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

EMC 1 Russel J. Thomsen, MD Vol#: 1

EMC 2 Russel J. Thomsen, MD Vol#: 1

EMC 3 Russel J. Thomsen, MD Vol#: 1

EMC 4 Russel J. Thomsen, MD Vol#: 1

EMC 5 Russel J. Thomsen, MD Vol#: 1

EMC 6 Russel J. Thomsen, MD Vol#: 1

EMC 7 Russel J. Thomsen, MD Vol#: 1

EMC 8 Russel J. Thomsen, MD Vol#: 1

EMC 9 Russel J. Thomsen, MD Vol#: 1

03V-0095 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 FX Unlimited Vol#: 1

03V-0096

VAR 1 P A Systems & Lighting Vol#: 1