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 November 15, 2002

TABLE OF CONTENTS

Hyper links are part of the Docket  title - not all dockets/documents are linked

NOTE:  Documents received by the Dockets Management Branch "MAY" be posted on the Internet. PLEASE DO NOT include personal identifying information, i.e. date of birth, social security number, etc., in your correspondence.

[FDA DOCKETS PAGE] [FDA HOME PAGE]  [ ITEM CODES ]

 
92S-0251 Electronic Submissions; Establishment of Public Docket *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
00D-1539 Electronic Records & Signatures, Retention of Electronic Rec *
00N-1571 Enrofloxacin for Poultry: Opportunity for hearing *
01P-0350 Determine whether Sotradecol has been withdrawn from sale in *
01P-0572 Petition for Regulation of Ariva Tobacco Lozenges *
02D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate *
02D-0333 Juice HACCP Hazards and Controls *
02D-0337 Liposome Drug Products:Chemistry, Manufacturing, and Control *
02N-0209 Governing First Amendment Case Law *
02N-0445 FDA Regulation of Combination Products; Public Hearing *
02P-0059 Refrain from Approving ANDA for Isotretinoin Drug Products *
02P-0075 Flavored Candy-like Products Containing Tobacco *

92S-0251 Electronic Submissions; Establishment of Public Docket

M 25 CBER Blood Establishment Registration Vol#: 1

94M-0269 PMA Inoue Balloon Catheter

AAV 1 Toray Industries Inc. (America) Vol#: 1

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

C 437 11 Signatures Vol#: 13

C 438 20 Signatures Vol#: 13

97P-0360 Expiration Date Labeling of Food Products

EMC 1 Gerald Robinson Vol#: 1

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

EMC 1111 M Vol#: 198

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

C 6137 Ms. Rose Johnson Vol#: 266

C 6138 Annette & Jim Brooks Vol#: 266

C 6139 Seneca Surgical Inc. Vol#: 266

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

EMC 403 Elisabeth Roberts Vol#: 5

EMC 404 Eleanor Garrell Berger Vol#: 5

EMC 405 F. Genniro Vol#: 5

EMC 406 F. Genniro Vol#: 5

EMC 407 A. Pasamante Vol#: 5

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

EMC 306 Elisabeth Roberts Vol#: 5

EMC 307 Eleanor Garrell Berger Vol#: 5

EMC 308 F. Genniro Vol#: 5

EMC 309 F. Genniro Vol#: 5

EMC 310 A. Pasamante Vol#: 5

EMC 311 S. Haus Vol#: 5

99F-5322 Ionizing Radiation for the Treatment of Food

EMC 305 Elisabeth Roberts Vol#: 4

EMC 306 Eleanor Garrell Berger Vol#: 4

EMC 307 F. Genniro Vol#: 4

EMC 308 F. Genniro Vol#: 4

EMC 309 A. Pasamante Vol#: 4

EMC 310 S. Haus Vol#: 4

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

EMC 308 Elisabeth Roberts Vol#: 4

EMC 309 Eleanor Garrell Berger Vol#: 4

EMC 310 F. Genniro Vol#: 4

EMC 311 F. Genniro Vol#: 4

EMC 312 A. Pasamante Vol#: 4

EMC 313 S. Haus Vol#: 4

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

EMC 3790 Erica Gray Vol#: 512

EMC 3791 Violet Cominski Vol#: 512

EMC 3792 Eleanor Garrell Berger Vol#: 512

EMC 3793 Susan Jeanes Vol#: 512

EMC 3794 S. Haus Vol#: 512

EMC 3795 F. Genniro Vol#: 512

EMC 3796 A. Passamante Vol#: 512

EMC 3797 Adriana Totaro Vol#: 512

EMC 3798 Brian McGee Vol#: 512

EMC 3799 Jackie Sowden Vol#: 512

EMC 3800 Amy Todisco Vol#: 512

EMC 3801 Rick Connor Vol#: 512

99P-1340 Declared Eternity eau de Parfum Misbranded

C 749 Form letters count 9 Vol#: 22

EMC 417 Linda Conrad Vol#: 21

EMC 418 Barbara Harrison Vol#: 21

00D-1539 Electronic Records & Signatures, Retention of Electronic Rec

EMC 5 UNISYS Vol#: 6

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

CS 15 HFA-305 Vol#: 270

OR 16 HF-3 Vol#: 270

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

EMC 405 Elisabeth Roberts Vol#: 6

EMC 406 Eleanor Garrell Berger Vol#: 6

EMC 407 F. Genniro Vol#: 6

EMC 408 F. Genniro Vol#: 6

EMC 409 A. Pasamante Vol#: 6

EMC 410 S. Haus Vol#: 6

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

EMC 1141 No signature Vol#: 5

EMC 1142 T. Rozee Vol#: 5

EMC 1143 Nancy Lee Pilger Vol#: 5

EMC 1144 Amy Anderson Vol#: 5

01P-0350 Determine whether Sotradecol has been withdrawn from sale in

LET 3 HFD-7 to Bennett and Company Vol#: 1

LET 4 HFD-7 to Omega Laboratories, Ltd. Vol#: 1

01P-0572 Petition for Regulation of Ariva Tobacco Lozenges

SUP 3 GlaxoSmithKline Consumer Healthcare (GSK Vol#: 2

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

C 28 Margaret Koren, MD Vol#: 1

C 29 Joan Davidson Vol#: 1

C 30 Pride B. Forney Vol#: 1

C 31 Leslie Rife Vol#: 1

C 32 Clara M. Sinclair Vol#: 1

C 33 M.P. Morrison Vol#: 1

C 34 Barbara F. Scott Vol#: 1

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

C 7 Sidney Smith, MD Vol#: 1

C 8 Advanced Medical Technolgy Assn Vol#: 1

02D-0333 Juice HACCP Hazards and Controls

C 8 International Diary Foods Assn et al. Vol#: 1

C 9 American Fresh Juice Council Vol#: 1

EMC 1 International Diary Foods Assn et al. Vol#: 1

02D-0337 Liposome Drug Products:Chemistry, Manufacturing, and Control

C 4 Bayer Corporation Vol#: 1

02N-0209 Governing First Amendment Case Law

EMC 220 number not used Vol#: 25

EMC 221 IMDMC, Indiana Medical Device Mfrs Counc Vol#: 25

EMC 222 Suzanne V. Vol#: 25

02N-0445 FDA Regulation of Combination Products; Public Hearing

APE 30 Mitek Worldwide Vol#: 3

APE 31 Aventis Behring Vol#: 3

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

EMC 37 M. Geldmacher Vol#: 1

EMC 38 Dr. Corey Cameron-Cooper Vol#: 1

EMC 39 Ruth Ritter Vol#: 1

EMC 40 Amy L. Lansky, PhD Vol#: 1

EMC 41 David Schantz Vol#: 1

EMC 42 Diane A. Ricucci Vol#: 1

EMC 43 Theresa Davidson Vol#: 1

EMC 44 Nitha M. White, DC Vol#: 1

EMC 45 Joanna Jaicks Vol#: 1

EMC 46 Shirley B. Vol#: 1

EMC 47 Tracey Mitchell, PharmD Vol#: 1

EMC 48 Wolfgang Gelbmann Vol#: 1

EMC 49 Susan Rogers McCreary Vol#: 1

EMC 50 Ray Gallup Vol#: 1

EMC 51 Edith Martin Vol#: 1

EMC 52 Jane A. Sherwin, RN Vol#: 1

EMC 53 Samantha McTighe Vol#: 1

EMC 54 J. Clarke Vol#: 1

EMC 55 Amy Todisco Vol#: 1

02P-0059 Refrain from Approving ANDA for Isotretinoin Drug Products

PAV 1 HFD- 1 to Hoffmann-La Roche Inc. Vol#: 1

02P-0075 Flavored Candy-like Products Containing Tobacco

SUP 2 GlaxoSmithKline Consumer Healthcare (GSK Vol#: 2

02P-0116 Sec. 480.200 Expiration Dating of Unit Dose Repackaged Drugs

EMC 1 Gerald Robinson Vol#: 1

02P-0317 Recall Aspartame as a Neurotoxic Drug

EMC 55 Kay Jenkins Vol#: 1

EMC 56 Diana Moore Vol#: 1

EMC 57 Miriam Allen Vol#: 1

EMC 58 Penny Clark Vol#: 1

EMC 59 Marian Ziegler Vol#: 1

02V-0488 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 N/A Private Residence Vol#: 1