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DOCKETS ENTERED on 3/6/03

Docket Number - Title

75N-183F Topical Antimicrobial Drug Products For OTC Human Use *
75N-183H Health-Care Antiseptic Drug Products for OTC Human Use *
80N-0280 Vaginal Contraceptive Drug Products for OTC Use *
95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability *
96N-0277 Eligibility Criteria for Considering Additional Condition *
98N-1109 Mercury Compounds in Drugs and Food *
00N-0598 Dietary Supplement Health Claim/Implementation of Pearson De *
02D-0018 Race and Ethnicity Data in Clinical Trials for FDA *
02D-0449 Administrative New Animal Drug Appilication Process *
02D-0492 Clinical Trials for Therapeutics in Adult Healthy Volunteers *
02D-0509 Intl Conference on Harmonisation/M4 Common Technical Documen *
03D-0060 Part11, Electronic records, electronic signatures scope *
03N-0059 Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach *
03P-0089 Loratadine in 10 Milligrams Orally Disintegrating Tablets *
75N-183F Topical Antimicrobial Drug Products For OTC Human Use

LET 9 Thursday Plantation Laboratories, Limite Vol#: 8

75N-183H Health-Care Antiseptic Drug Products for OTC Human Use

LET 37 Thursday Plantation Laboratories, Limite Vol#: 149

80N-0280 Vaginal Contraceptive Drug Products for OTC Use

EC 121 Number Not Used Vol#: 14

EC 122 Maricopa County Public Health Dept Vol#: 14

80N-145B Safety & Efficacy Review for OTC Ophthalmic Drug Prod.

BKG 1 Background Material Refs 1 - 17 Vol#: 2

91N-384H Nutrient Content Claims, Definition of Term: Healthy

EMC 1 Carol Harvey Vol#: 13

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

EC 1 Mrs. Roberta Boothby Vol#: 298

EC 2 Faith Regional Health Services Vol#: 298

EC 3 None - Individual Vol#: 298

EC 4 Mrs. Michele Conklin Vol#: 298

EC 5 Number Not Used Vol#: 298

EC 6 Mr. Alan Frayer Vol#: 298

EC 7 DeVos Children's Hospital Vol#: 298

EC 8 Mr. Tim Geary Vol#: 298

EC 9 in the makings Vol#: 298

EC 10 Mr. Michael Eiker Vol#: 298

EC 11 Dr. Lyle Najita Vol#: 298

EC 12 Dr. Bruce Tetalman Vol#: 298

EC 13 Mr. David Siscoe Vol#: 298

EC 14 Miss Robert Lebow Vol#: 298

EC 15 Dr. Robert Lebow Vol#: 298

EC 16 Mr. Nick Orlando Vol#: 298

EC 17 Mr. William McGowen Vol#: 298

EC 18 Goen Technologies Vol#: 298

EC 19 Mr. Andrew Guzik Vol#: 298

EC 20 Dr. Jose Antonio Vol#: 298

EC 21 Mr. Douglas Kalman Vol#: 298

EC 22 Mrs. Mary Butler Vol#: 298

EC 23 Mrs. Shannon Camp Vol#: 298

EC 24 Northwest Medical Center Vol#: 298

EC 25 Dr. Guy Kiracofe Vol#: 298

EC 26 CENPHR, Baylor University Vol#: 298

EC 27 Mr. Thomas Arthur Vol#: 298

EC 28 Mr. larry pippin Vol#: 298

EC 29 Mrs. JOANNA HAACK Vol#: 298

EC 30 Mr. Richard Trump Vol#: 298

EC 31 Mrs. Melissa Wohlever Vol#: 298

EC 32 none Vol#: 298

EC 33 Mr. Aaron Agostini Vol#: 298

EC 34 Miss Jennifer Gagnon Vol#: 298

96N-0277 Eligibility Criteria for Considering Additional Condition

LET 14 Thursday Plantation Laboratories, Limite Vol#: 5

98N-1109 Mercury Compounds in Drugs and Food

LET 1 Rugby Labs., a div of Watson Pharma, Inc Vol#: 2

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

C 6327 Holly M. Heitkamp Vol#: 273

C 6328 Linda Malmqust Vol#: 273

C 6329 Nushin Amirhoseini Vol#: 273

C 6330 Lynn Vol#: 273

C 6331 Crystal S. Marshall Vol#: 273

C 6332 Mr. Vincent P. Bianchini Vol#: 273

C 6333 Bill Venditti Vol#: 273

C 6334 June Faulk Vol#: 273

C 6335 David & Ann Peck Vol#: 273

C 6336 Laura Gruenebaun Vol#: 273

C 6337 Nancy Whitenack Vol#: 273

C 6338 Karen Ruge Vol#: 273

C 6339 Mary H. Jinno Vol#: 273

C 6340 Charlotte & Frank Marchese Vol#: 273

C 6341 Joanne K. Stokoe Vol#: 273

C 6342 John O. Jones Vol#: 273

C 6343 Florince Francis Vol#: 273

C 6344 Ms. Mary Ann Wilson Vol#: 273

00N-0598 Dietary Supplement Health Claim/Implementation of Pearson De

WDL 1 Grocery Manufacturers of America Vol#: 7

01P-0230 Domestic Marketing & Importation of Transgenic Fish

EMC 2692 J. Rosenberry Vol#: 228

EMC 2693 Victoria Sievers Vol#: 228

EMC 2694 Kathleen Moore Vol#: 228

02D-0018 Race and Ethnicity Data in Clinical Trials for FDA

EC 3 NIH Vol#: 1

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

C 625 Philip Lewin Vol#: 13

02D-0449 Administrative New Animal Drug Appilication Process

C 3 AHI, Animal Health Institute Vol#: 1

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

C 2 Pharmacia Corp. Vol#: 1

C 3 Quintiles, Inc. Vol#: 1

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

C 6 GlaxoSmithKline Vol#: 1

C 7 Bristol-Myers Squibb Vol#: 1

EMC 1 GlaxoSmithKline Vol#: 1

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

EC 63 Eldon Industrial Corp Vol#: 7

EC 64 NTCBFFA - Regulatory Agencies Chair Vol#: 7

EC 65 Dr. Verne House Vol#: 7

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

EC 1 Karen Ashworth Consulting Ltd Vol#: 1

EC 2 TDV Vol#: 1

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

EC 6 Fasor Inc Vol#: 1

EC 7 Number Not Used Vol#: 1

EC 8 Number Not Used Vol#: 1

03P-0089 Loratadine in 10 Milligrams Orally Disintegrating Tablets

ACK 1 HFA-305 Vol#: 1

CP 1 Andrx Pharmaceutical, Inc. Vol#: 1