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DOCKETS ENTERED on 2/27/03

Docket Number - Title

ANS 1 CDER to Patricia Charache, M.D. Vol#: 1

C 20 BioQuiest Vol#: 1

80N-0280 Vaginal Contraceptive Drug Products for OTC Use

EC 106 Miss Leslie Ashby Vol#: 14

EC 107 Ms. Karen Parkin Vol#: 14

EC 108 Mr. Jason Sallee Vol#: 14

EC 109 Mrs. Victoria Sprague Vol#: 14

EC 110 AWHONN Vol#: 14

EC 111 Ms. ERIN PEHL Vol#: 14

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

BKG 2 Background Material Refs 1 - 10 Vol#: 14

NPR 3 Vol#: 14

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

BKG 1 Background Material Refs 1 - 10 Vol#: 11

NPR 1 Vol#: 11

98D-0834 Non-Contraceptive Estrogen Class Labeling

EC 3 AWHONN Vol#: 1

99E-5114 Patent Extension EVISTA, raloxifene hydrochloride, 4,418,068

EC 1 Dr. Donald Belt Vol#: 1

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

C 70 Center for Food Safety & Public Citizen Vol#: 7

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

C 68 Center for Food Safety & Public Citizen Vol#: 7

99F-5322 Ionizing Radiation for the Treatment of Food

C 67 Center for Food Safety & Public Citizen Vol#: 5

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

C 69 Center for Food Safety & Public Citizen Vol#: 5

00E-1404 Patent Extension Levulan Kerastick, No. 5,079,262

LET 3 HFD-005 to Honorable James E. Rogan Vol#: 1

00N-1219 Bacterial Vaccines & Related Biological Products

NPH 1 Vol#: 1

00N-1427 Proposal to Debar Edmund J. Striefsky;Notice of Opportunity

LET 2 DHHS Philadelphia District to Dave Reed Vol#: 1

01E-0030 Patent Extension for TEQUIN, No. 4,980,470

LET 3 HFD-005 to Honorable James E. Rogan Vol#: 1

01E-0367 Patent Term Extension Application, STARLIX No. 34,878

N 1 Vol#: 1

01E-0419 Patent Term Extension Application, Precedex No. 4,910,214

LET 2 HFD-005 to Honorable James E. Rogan Vol#: 1

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

C 66 Center for Food Safety & Public Citizen Vol#: 7

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 1316 Amy Jane Baker Vol#: 233

C 1317 Jessica Leland Vol#: 223

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

C 613 Janice E. Evans, MD Vol#: 13

C 614 Audrey Malloy Vol#: 13

C 615 Barry Pfundt Vol#: 13

C 616 Cathy Kristiansen & Mark Cohen Vol#: 13

C 617 Snack Food Assn Vol#: 13

C 618 Marilyn Hill Vol#: 13

02D-0402 Field offices on "Regulatory procedures Manual, Chapter 9

EC 3 Number Not Used Vol#: 1

02D-0468 Manufacture and Labeling of Raw Meat Foods

C 4 Robert P. Kaufman, DVM Vol#: 1

EC 15 Ms. Sharon Hann Vol#: 1

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

C 2 Merck & Co., Inc. Vol#: 1

C 3 Johnson & Johnson Pharmaceutical Vol#: 1

02E-0150 Gynecare Intergel, U.S. Patent Extension No. 5,532,221

LET 3 HFD-005 to Honorable James E. Rogan Vol#: 1

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

BKG 1 Background Material Refs 1 - 5 Vol#: 1

NFR 1 Vol#: 1

02N-0209 Governing First Amendment Case Law

C 105 Marcy Kaptur (CI) Vol#: 19

C 106 Sherrod Brown (CI) Vol#: 19

C 107 Betty McCollum (CI) Vol#: 19

C 108 Janice D. Schakowsky (CI) Vol#: 19

C 109 Rosa L. DeLauro (CI) Vol#: 19

C 110 Nita M. Lowey (CI) Vol#: 19

02N-0259 FDA Lyme Vaccine Safety Study;Agency Information Collection

NAL 1 Vol#: 1

02N-0276 Bioterrorism Preparedness;Registration of Food Facilities

EC 54 Vitamor Kft Vol#: 3

EC 55 Ozbulut Gyda San.Tic.Ltd.?ti Vol#: 3

EC 56 The Union Frozen Products Co.,Ltd Vol#: 3

EC 57 Mr. Dietmar Schott Vol#: 3

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

C 36 Charles E. Schuster, RS Vol#: 7

C 37 Form Letters 5 Vol#: 8

EC 56 USDA /FAS / Vietnam Vol#: 3

EC 57 Vitamor Kft Vol#: 3

EC 58 Ozbulut Gyda San.Tic.Ltd.?ti Vol#: 3

EC 59 Number Not Used Vol#: 3

02N-0296 Investigational New Drug Regulations;Agency Information Coll

NAL 1 Vol#: 1

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

C 8 Advanced Medical Technology Assn Vol#: 1

C 9 Henry Schein, Inc. Vol#: 1

C 10 Boston Scientific Corporation (BSC) Vol#: 1

C 11 Boston Scientific Corporation (BSC) Vol#: 1

C 12 Boston Scientific Corporation (BSC) Vol#: 1

C 13 Boston Scientific Corporation (BSC) Vol#: 1

02P-0297 ANDA for Propoxyphene Hydrochloride, Acetaminophen&Caffeine

PAV 1 HFD-600 to Lachman Consultant Services, Vol#: 1

02P-0386 Abbreviated new drug application (ANDA)7.5 mg hydrocodone

PAV 1 HFD-600 to Pharmaceutical Associates, I Vol#: 1

02P-0391 Determine Whether Alphagan has been Voluntarily Withdrawn

LET 1 HFD-1 to IVAX Pharmaceuticals Inc. Vol#: 1

02P-0404 Determination re: Withdraw of ALPHAGAN

LET 1 HFD-1 to Alcon Research, Ltd. Vol#: 1

02P-0459 Abbreviated new drug application(ANDA) for Metoprolol tartrt

PAV 1 HFD-601 to Lachman Consultant Services I Vol#: 1

02P-0460 25 mg metoprolol tartrate tablets drug product of ANDA

PAV 1 HFD-600 to Caraco Pharmaceutical Labs. Vol#: 1

03D-0061 Comparability Protocols Chemistry Manufacturing and controls

EC 1 Fine Chemicals Corporation Vol#: 1

03N-0017 Risk Management Programs on the Practice of Pharmacy

EC 1 Number Not Used Vol#: 1

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

EC 1 Pathway Press Vol#: 1

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

N 1 Vol#: 1

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

N 1 Vol#: 1

03P-0078 Public Health Security & Bioterrorism Preparedness & Respons

ACK 1 HFA-305 to Olsson, Frank and Weeda Vol#: 1

CP 1 Olsson,Frank and Weeda P.C Vol#: 1

03V-0047 Projector Model Number 3130 for Laser Light Show

VRA 1 HFZ-300 to Lightwave Lasers Vol#: 1