Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870; TTY/TDD Users 1-800-735-2258 - [E-mail Us]

DOCKETS ENTERED on 11/25/02

DOCKETS ENTERED on 11/24/02

TABLE OF CONTENTS

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77N-094I Internal, Analgesic, Antipyretic, and Antirheumatic Drug Pro *
87P-0339 HALDOL (HALOPERIDOL DECANOATE) RECEIVE 5 YEAR MARKET EXCL *
92P-0058 Regulations for Wax Coatings on Fresh Fruits & Vegetables *
95N-0308 Inapplicability of the Dietary Supplement Health & Ed. Act t *
98N-1038 Irradiation in the production, processing, &handling of food *
00N-1528 Proposal to Debar Delfina Hernandez;Notice of Opportunity *
01P-0120 Ban Unsafe IV Catheters and other Devices *
02D-0258 Studies for Orally Administered Drug Products *
02D-0320 Hold following clinical investigator misconduct *
02D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate *
02D-0333 Juice HACCP Hazards and Controls *
02N-0209 Governing First Amendment Case Law *
02N-0405 Med. Device Reporting: Mfg., Importer, User Facility & Distr *
02P-0483 Actions re: exceptive drug products, ex release guaifenesin *

DOCKETS ENTERED on 11/24/02 *

78N-036L OTC Laxative *

77N-094I Internal, Analgesic, Antipyretic, and Antirheumatic Drug Pro

C 2 National Kidney Foundation Vol#: 1

87P-0339 HALDOL (HALOPERIDOL DECANOATE) RECEIVE 5 YEAR MARKET EXCL

ACK 1 HFA-305 Vol#: 1

92P-0058 Regulations for Wax Coatings on Fresh Fruits & Vegetables

SUP 27 Citizen Petition, Inc. Vol#: 2

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

C 441 Richard H. Kreycik Vol#: 13

C 442 Maura Becker Vol#: 13

C 443 Whimsy Brook Farm, Ltd. Vol#: 13

C 444 Kennedy Indian ArtsLtd. Vol#: 13

98N-0359 Program priorities/Center for Food Safety & Applied Nutritin

C 91 No signature Vol#: 7

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

C 5695 The Renaissance Consulting Group Vol#: 193

98P-0203 Eliminate Forced Molting of Laying Birds

C 1962 Jeanne Ellis Vol#: 47

99P-1340 Declared Eternity eau de Parfum Misbranded

C 750 M. C. Little Vol#: 21

00N-1528 Proposal to Debar Delfina Hernandez;Notice of Opportunity

LET 2 Delfina Hernandez Vol#: 1

01P-0120 Ban Unsafe IV Catheters and other Devices

C 32 Assn of periOperative Registered Nurses Vol#: 3

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 1250 Joan Birch & Jim Rogoff Vol#: 226

C 1251 Kate Reese Hurd Vol#: 226

C 1252 April O'Connor Vol#: 226

EMC 2563 Amelia Grigg (Australia) Vol#: 228

EMC 2564 Gillian Kehler (Canada) Vol#: 228

EMC 2565 Loreto Lagos (Chile) Vol#: 228

EMC 2566 Anton Klepke (Sweden) Vol#: 228

EMC 2567 Lisa Baxter (Australia) Vol#: 228

EMC 2568 Tegwyn Bath (Australia) Vol#: 228

EMC 2569 Sarah Jackson (Australia) Vol#: 228

EMC 2570 James Davenport Vol#: 228

EMC 2571 Donovan Dobbins Vol#: 228

EMC 2572 Jay Williamson (United Kingdom) Vol#: 228

EMC 2573 Chris Fitzgerald Vol#: 228

EMC 2574 Blake Van Roman (Mexico) Vol#: 228

EMC 2575 Monica Dance (New Zealand) Vol#: 228

EMC 2576 Cory Golden Vol#: 228

EMC 2577 Judith Hayner Vol#: 228

EMC 2578 Mark Olbrych Vol#: 228

EMC 2579 Lisa Boyd Vol#: 228

EMC 2580 AD Sunderland Vol#: 228

EMC 2581 Gregg Mau Vol#: 228

EMC 2582 Devin Waters Vol#: 228

EMC 2583 Rae Ann Siewert Vol#: 228

02D-0258 Studies for Orally Administered Drug Products

C 10 Johnson & Johnson Pharm Research & Dev Vol#: 1

02D-0320 Hold following clinical investigator misconduct

C 4 Schering-Plough Vol#: 1

C 5 Hogan & Hartson Vol#: 1

C 6 PhRMA Vol#: 1

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

C 41 Don Riggs Vol#: 1

C 42 M. Davies Vol#: 1

C 43 Kathleen Clarkson Vol#: 1

C 44 John R. Manning Vol#: 1

C 45 Rita Bonasera Vol#: 1

C 46 Sr. Corde Rea, O.S.F. Vol#: 1

C 47 Dr. Mha Atma S. Khalsa Vol#: 1

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

C 9 Vanessa Poster Vol#: 1

C 10 International Health & Tobacco Steering Vol#: 1

C 11 Ecology Center of Southern California Vol#: 1

02D-0333 Juice HACCP Hazards and Controls

C 11 Bowman Apple Products Company, Inc. Vol#: 1

C 12 Florida Department of Agriculture (FDACS Vol#: 1

02D-0439 Transcutaneous Air Conduction Hearing Aid System

GDL 1 Guidance Vol#: 1

NAD 1 Vol#: 1

02N-0209 Governing First Amendment Case Law

EMC 223 Joan B. Lee Vol#: 25

EMC 224 Kathleen Nimr Vol#: 25

02N-0405 Med. Device Reporting: Mfg., Importer, User Facility & Distr

C 1 Command Trust Network, Inc. Vol#: 1

02N-0466 Safety, Clinical and Immune Response of Dryvax

C 3 Patricia Ferro Vol#: 1

C 4 Ellen Yerger Vol#: 1

C 5 Kathleen Hills Vol#: 1

C 6 Constance L. Millstein Vol#: 1

C 7 Jane S. Barrett Vol#: 1

02P-0483 Actions re: exceptive drug products, ex release guaifenesin

C 1 Adams Labs., Inc. Vol#: 1

DOCKETS ENTERED on 11/24/02

78N-036L OTC Laxative

ACK 21 HFA-305 Vol#: 80