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DOCKETS ENTERED on 4/18/03

Docket Number - Title

80N-0280 Vaginal Contraceptive Drug Products for OTC Use

C 54 IBIS Reproductive Health Vol#: 12

EMC 4 Grays Harbor County Public Health Vol#: 12

EMC 5 Citizens Alliance for VD Awareness CAVDA Vol#: 12

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

EMC 743 North American Spine Society Vol#: 346

EMC 744 J. Foote Vol#: 346

EMC 745 Vonnie Schultz Albrecht Vol#: 346

EMC 746 Mark McClellan Vol#: 346

EMC 747 North American Spine Society Vol#: 346

EMC 748 American College of Physicians Vol#: 346

EMC 749 Council of Acupuncture & Oriental Medici Vol#: 346

EMC 750 Christene R. Nemeth Vol#: 346

EMC 751 Pharmaceutical Printed Literature Assn Vol#: 346

EMC 752 Lee Rose Vol#: 346

EMC 753 American College of Physicians Vol#: 346

EMC 754 South Dakota State University Vol#: 346

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

C 6442 Rosemary Vol#: 276

C 6443 Joseph & Dolores Caruana Vol#: 276

C 6444 Marguerite Velasguez Vol#: 276

C 6445 Kathleen Geary Vol#: 276

C 6446 Lisa Klein Vol#: 276

C 6447 Laurel Lyall Vol#: 276

C 6448 Josh Craven Vol#: 276

C 6449 Mrs. C. W. Bainter Vol#: 276

C 6450 Suzanne Pasini Vol#: 276

C 6451 Marcey R. Crisan Vol#: 276

C 6452 Lisa Schreiner Vol#: 276

C 6453 Nicole Hedgemenn Vol#: 276

C 6454 Judy Simpson-Calandra Vol#: 276

C 6455 Miss Linda Appel Vol#: 276

C 6456 Kerry Holliday Vol#: 276

C 6457 Dorothea Goetz Vol#: 276

C 6458 Terri Osuch Vol#: 276

C 6459 Laura Deitemeyer Vol#: 276

C 6460 Gail Ellifritz Vol#: 276

C 6461 Michele L. Deisering Vol#: 276

C 6462 Roman Krupa Vol#: 276

C 6463 Doreen N. Nespolini Vol#: 276

C 6464 Stacy Lybrand Vol#: 276

C 6465 Bernard Caley Vol#: 276

C 6466 Glen Wilson Vol#: 276

C 6467 Patti Breitman Vol#: 276

C 6468 Juliet Dorn Vol#: 276

C 6469 Mrs. Joyce E. Ritchie Vol#: 276

EMC 3177 Sean Milus Vol#: 265

EMC 3178 Domenick Greco Vol#: 265

EMC 3179 Cheryl Rudd Vol#: 265

EMC 3180 Martine Hedges Vol#: 265

EMC 3181 Bradley R. West Vol#: 265

EMC 3182 Rhonda Anderson Vol#: 265

EMC 3183 Diane & Lee Kirkland Vol#: 265

EMC 3184 Genevieve M. Allen Vol#: 265

EMC 3185 Elissa Mendenhall Vol#: 265

00E-1248 Patent Extension Tikosyn (dofetilide) #4,959,366

N 1 Vol#: 1

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9451 Form Letters Count 161 Vol#: 411

EMC 11561 Rileys Vol#: 349

00N-1484 Safety Reporting Requirements Human Drug/Biological Products

EMC 4 SNOMED International Vol#: 3

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 12709 Irina Paiste Vol#: 788

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

EMC 437 Center for Food Safety Vol#: 7

EMC 438 Agricultural Organization/Food & Agri-Bu Vol#: 7

01N-0067 Reclassification of Dental Mercury

EMC 652 Peter Matteson Vol#: 17

01N-0275 Performance standard for Diagnostic X-Ray Systems & Major Co

EMC 2 American Assn of Physicists in Medicine Vol#: 4

01P-0230 Domestic Marketing & Importation of Transgenic Fish

EMC 2716 Albert White III Vol#: 228

EMC 2717 Dick Artley Vol#: 228

EMC 2718 Katie Agalzoff Vol#: 228

EMC 2719 Tamara Sachs, M.D. Vol#: 228

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

EMC 1168 A. Hume Edmonds, Jr. Vol#: 5

EMC 1169 Kathy Vol#: 5

EMC 1170 Alois Hubin, M.Sc.A Vol#: 5

EMC 1171 No signature Vol#: 5

01P-0470 Establish Appropriate Approval Standards for Generic Clonidi

C 3 Mylan Technologies Inc Vol#: 2

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

C 637 Form Letters Count 12 Vol#: 14

02N-0209 Governing First Amendment Case Law

BRF 1 Pfizer, Inc. Vol#: 26

C 111 Pfizer, Inc. Vol#: 26

02N-0275 Bioterrorism Preparedness; Administrative Detention

EMC 18 Ministry of Agriculture of Ecuador Vol#: 3

02N-0277 Bioterrorism; Establishment & Maintenance of Records

EMC 19 Ministry of Agriculutre of Ecuador Vol#: 4

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

EMC 103 Honorable Patrick Leahy Vol#: 11

EMC 104 Ministry of Agriculutre of Ecuador Vol#: 11

EMC 105 Federacion Ecuatoriana de Exportadores Vol#: 11

02N-0475 Financial Relationships & Interest in Research Involving Hum

EMC 2 AHRP, The Alliance for Human Res. Protec Vol#: 1

02N-0528 Risk Management Workshop, April 9-11, 2003 [PDUFA III]

EMC 8 Pharmaceutical Safety Assessments, Inc. Vol#: 1

EMC 9 Reconnaissance Intl Vol#: 1

EMC 10 Pharmacia Corporation Vol#: 1

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

EMC 4 Medical Device Manufacturers Assn (MDMA) Vol#: 2

02P-0029 Mylan estradiol transdermal system as generic substitute

C 1 Mylan Technologies, Inc. Vol#: 1

02P-0057 Relisting of Ventolin Albuterol Sulfate Inhalation

LET 1 HFD-007 to Nephron Pharmaceuticals Corp. Vol#: 1

02P-0317 Recall Aspartame as a Neurotoxic Drug

EMC 243 Betty Martini Vol#: 5

02P-0424 ANDA for Loperamide Hydrochloride 1 mg Soft Gelatin Capsules

PAV 1 HFD-600 to Banner Pharmacaps Inc. Vol#: 1

02P-0437 Protect patients & consumers in U.S. by amending the 510(k)

LET 1 HFZ-1 to Richard A. Stolworthy Vol#: 1

02P-0498 ANDA Warfarin Sodium Tablets, USP 0.5 mg. (Coumadin tablets)

PAV 1 HFD-600 to Taro Pharmaceuticals Vol#: 1

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

LET 4 INC Nutrition Res. & Education Foundatio Vol#: 4

03D-0001 Nonclinical Safety Evaluation of Pediatric Drug Products

C 3 Bristol-Myers Squibb Vol#: 1

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

EMC 2 American Society for Quality (ASQ) Vol#: 1

EMC 3 Puget Sound Blood Center (PSBC) Vol#: 1

EMC 4 CRF Box, Ltd Vol#: 1

03E-0031 Patent Extension Application for VFEND No. 5,567,817

N 1 Vol#: 1

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

EMC 2 National Center for Policy Research for Vol#: 1

EMC 3 Blue Cross & Blue Shield Assn Vol#: 1

03N-0056 Patient Examination & Surgeons' Gloves; Test Procedures

EMC 1 Akron Rubber Development Laboratory, Inc Vol#: 1

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

EMC 1 PhRMA Vol#: 1

03N-0069 FDA Task Force on Consumer Health Info for Better Nutrition

EMC 1 John & Dawn Hoogerbrugge Vol#: 1

03P-0166 Revoke Approval for Marketing of Menstrual Cups

ACK 1 HFA-305 Vol#: 1

CP 1 Associated Pharmacologists & Toxicologis Vol#: 1