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DOCKETS ENTERED on April 15, 2002

TABLE OF CONTENTS

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76N-052N OTC Nasal Decongestants*
78N-0064 OTC Antiperspirant *

88N-0038 Records & Reports concerning experience w/ new animal drugs *
88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE *
95N-0308 Inapplicability of the Dietary Supplement Health & Ed. Act t *
98N-0046 Comprehensive List of Current Guidance Documents at FDA *
99P-5332 Amend limit Hydrogenated & partially Hydrogenated Menhaden O *
01D-0582 Available Therapy *
01N-0322 Institutional Review Boards *
01N-0587 Changes to an approved application labeling forms 356h&2567 *
01P-0470 Establish Appropriate Approval Standards for Generic Clonidi *
01P-0495 Determine Ultram's safety or effectiveness reasons *
01P-0570 Petition for Regulation of R.J. Reynolds Eclipse Products *
02D-0003 Exercise-Induced Bronchospasm (EIB),Drug Developoment to Pre *
02D-0039 Medical Sterilization Packaging Systems *
02P-0013 Rescind GRAS Status for Aluminum-containing Food Additives *
02P-0045 SURGISIS Periodontal Membrane (D.C. #K010952) *
02P-0154 The Labeling of Serono's REBIF is Misleading *

76N-052N OTC Nasal Decongestants

ACK 5 HFA-305 Vol#: 78

CP 18 Bayer Corporation Vol#: 78

78N-0064 OTC Antiperspirant

ACK 1 HFA-305 Vol#: 51

CP 4 Cosmetic, Toiletry, and Fragrance Assn. Vol#: 51

88N-0038 Records & Reports concerning experience w/ new animal drugs

EC 2 Novartis Animal Health US, Inc. Vol#: 2

88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE

WDL 1 Pharmaceutical Distributors Association Vol#: 6

92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992

WDL 1 Pharmaceutical Distributors Association Vol#: 8

93D-0139 Stability Testing of Biotechnological/Biological Products

EC 5 PT. Romindo Primavetcom (Factory Manager Vol#: 2

95N-0308 Inapplicability of the Dietary Supplement Health & Ed. Act t

C 94 Allison L. Martin Vol#: 3

C 95 Carol Watkins Vol#: 3

C 96 Penny Wallin Vol#: 3

C 97 Carol Gillis, DVM, Ph.D. Vol#: 3

C 98 Kris Skoog Vol#: 3

C 99 Judy Sinner Vol#: 3

C 100 Sandra L. LeMarr Vol#: 3

C 101 Sherry & Gary Lindsey Vol#: 3

C 102 Brian Ferguson & Lisa von Pechmann Vol#: 3

C 103 Marylouise Poli Vol#: 3

C 104 Greater Atlanta Veterinary Medical Group Vol#: 3

C 105 Alexandra Moffat Vol#: 3

C 106 Mrs. Donna Ford Vol#: 3

C 107 Sunrise Stables L.L.C. Vol#: 3

C 108 Susan K. Zondor Vol#: 3

C 109 Carol Ochs Vol#: 3

98N-0046 Comprehensive List of Current Guidance Documents at FDA

EC 2 Jewish General Hospital Vol#: 1

98N-1038 Irradiation in the production, processing, &handling of food

EMC 1035 Shivani Arjuna Vol#: 197

99P-1340 Declared Eternity eau de Parfum Misbranded

EMC 368 Beverly A. Fourier Vol#: 21

EMC 369 Nelia F. Beaman Vol#: 21

99P-5332 Amend limit Hydrogenated & partially Hydrogenated Menhaden O

C 1 Omega Protein Vol#: 1

00N-1200 Dietary Supplements Containing Ephedrine Alkaloids

EMC 35 Mascot Vol#: 78

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

C 12625 Rebecca Hawkes Vol#: 783

C 12626 Richard Nawrocki Vol#: 783

01D-0532 Food Code; 2001 Revision

EC 7 N/A Vol#: 1

01D-0582 Available Therapy

C 1 Merck Research Laboratories Vol#: 1

EC 1 FDA/CDER Vol#: 1

01N-0322 Institutional Review Boards

C 3 Associatoin of American Medical Colleges Vol#: 1

C 4 Johns Hopkins University, Center for Cli Vol#: 1

01N-0499 Extralabel Animal Drug Use

EC 2 Number Not Used Vol#: 1

01N-0587 Changes to an approved application labeling forms 356h&2567

C 1 Merck Research Laboratories Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

EC 7 Ms. Caroline Sundquist Vol#: 141

01P-0470 Establish Appropriate Approval Standards for Generic Clonidi

C 1 Mylan Technologies Inc Vol#: 2

C 2 Mylan Technologies Inc Vol#: 2

LET 1 HFD-1 to Boehringer Ingelheim Pharm,Inc Vol#: 2

01P-0495 Determine Ultram's safety or effectiveness reasons

SUP 1 Apotex Corp. Vol#: 1

01P-0570 Petition for Regulation of R.J. Reynolds Eclipse Products

C 1 R J Reynolds Tobacco Company Vol#: 2

02D-0003 Exercise-Induced Bronchospasm (EIB),Drug Developoment to Pre

C 1 AstraZeneca LP Vol#: 1

02D-0039 Medical Sterilization Packaging Systems

C 2 St Vincent Hospital Vol#: 1

C 3 Getinge/Castle Inc Vol#: 1

02N-0054 Labeling Requirements for Color Additives

EC 1 Number Not Used Vol#: 1

02P-0013 Rescind GRAS Status for Aluminum-containing Food Additives

C 1 Institute for Basic Research In Dev. Dis Vol#: 1

02P-0045 SURGISIS Periodontal Membrane (D.C. #K010952)

WDL 1 Cook Biotech Incorporated Vol#: 1

02P-0154 The Labeling of Serono's REBIF is Misleading

ACK 1 HFA-305 Vol#: 1

CP 1 Biogen, Inc. Vol#: 1

02V-0153 Laser DNA Sequencer device 3100 genetic analyzer variance.

ACK 1 HFA-305 Vol#: 1

VAR 1 Hitachi High-Technologies Corp. (Japan) Vol#: 1

02V-0154 Laser light show.

ACK 1 HFA-305 Vol#: 1

VAR 1 Western Starlight, Inc. Vol#: 1