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 21, 2002

TABLE OF CONTENTS

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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.

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75N-183H Health-Care Antiseptic Drug Products for OTC Human Use *
02D-0320 Hold following clinical investigator misconduct *
02D-0337 Liposome Drug Products:Chemistry, Manufacturing, and Control *
02N-0276 Bioterrorism Preparedness;Registration of Food Facilities *
02N-0445 FDA Regulation of Combination Products; Public Hearing *
02N-0466 Safety, Clinical and Immune Response of Dryvax *
02P-0493 Anti-heart burn drug Omeprazole magnesium (brand Prilosec1) *

75N-183H Health-Care Antiseptic Drug Products for OTC Human Use

LET 33 HFC-1 to Aleavis International, Inc. Vol#: 60

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

BKG 2 BACKGROUND Vol#: 66

NEC 3 Vol#: 65

01Q-0313 Health Claim Petition for Soluble Fiber from Oatrim

EC 1 Number Not Used Vol#: 1

02D-0320 Hold following clinical investigator misconduct

EC 1 Pharmacia Vol#: 1

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

C 8 GlaxoSmithKline Vol#: 1

EC 1 Gilead Sciences, Inc Vol#: 1

EC 2 Gilead Sciences, Inc Vol#: 1

EC 3 GlaxoSmithKline Vol#: 1

02D-0385 Approval of Labeling for Foods Treated by Irradiation

EC 5 Mr. William Filicetti Vol#: 1

EC 6 Mrs. Tracy Thornburg Vol#: 1

EC 7 Mrs. Laurie Morgan Vol#: 1

02N-0273 Animal Proteins Prohibited in Ruminant Feed

EC 1 Mrs. Darlene Lerche Vol#: 1

EC 2 Mrs. Donna Gabrys Vol#: 1

02N-0276 Bioterrorism Preparedness;Registration of Food Facilities

ANS 1 HFS-4 to R E Rogers Inc. Vol#: 3

C 28 Government of Japan Vol#: 3

C 29 Embassy of Malaysia Vol#: 3

C 30 R E Rogers Inc. Vol#: 3

02N-0277 Bioterrorism; Establishment & Maintenance of Records

ANS 1 HFS-4 to R E Rogers Inc. Vol#: 3

C 25 Government of Japan Vol#: 3

C 26 Embassy of Malaysia Vol#: 3

C 27 R E Rogers Inc. Vol#: 3

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

ANS 2 HFS-4 to R E Rogers Inc. Vol#: 3

C 29 Government of Japan Vol#: 3

C 30 Embassy of Malaysia Vol#: 3

C 31 R E Rogers Inc. Vol#: 3

02N-0319 Blood Establishment Registration/Product Listing,formFDA2830

N 2 Vol#: 1

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

APE 35 Hogan & Hartson LLP Vol#: 3

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

C 2 Jane Mahon Vol#: 1

EC 292 Mr. Darren Adams Vol#: 3

EC 293 Mrs. Sheila Robles Vol#: 3

EC 294 Ms. Lynda Johnson Vol#: 3

EC 295 Ms. Mary Ellen Hegedus Vol#: 3

EC 296 Mrs. Lenora Day Vol#: 3

EC 297 Mrs. April Yeager Vol#: 3

EC 298 Mrs. Melissa Tumminello Vol#: 3

EC 299 Mrs. Barbara Farmer Vol#: 3

EC 300 Mr. Rob Sedgwick Vol#: 3

EC 301 Mrs. Janet Altum Vol#: 3

EC 302 Mrs. Michelle Sanders Vol#: 3

EC 303 Mrs. Judy Dietrich Vol#: 3

EC 304 Mrs. Erin McSparron Vol#: 3

EC 305 freelance medical writer Vol#: 3

EC 306 Mrs. Allison Earnest Vol#: 3

EC 307 Mrs. Michelle Novotny Vol#: 3

EC 308 Mrs. Rachael McGee Vol#: 3

EC 309 Allentown Health Bureau Vol#: 3

EC 310 SAVVI Crisis Center Vol#: 3

EC 311 Mrs. Laurie Morgan Vol#: 3

EC 312 AATH Michigan Vol#: 3

EC 313 Mr. Andrew Yeager Vol#: 3

EC 314 Mrs. Jessica Hudson Vol#: 3

EC 315 Number Not Used Vol#: 3

EC 316 none Vol#: 3

EC 317 Ms. Karen Valdez Vol#: 3

EC 318 Ms. Stefani Barner Vol#: 3

EC 319 Mrs. Tracy Thornburg Vol#: 3

EC 320 Emory University Student Health Service Vol#: 3

EC 321 Mrs. Traci Murphy Vol#: 3

EC 322 Miss Ursula Robertson Vol#: 3

EC 323 Ms. Monique van Hoek Vol#: 3

EC 324 CBRC/Mass General Hospital Vol#: 3

EC 325 Mrs. Brandi Maynard Vol#: 3

EC 326 Mr. Ronald Kippenhan Vol#: 3

EC 327 Ms. Christina Ducharme Vol#: 3

EC 328 Mrs. Julie Aguilar Vol#: 3

EC 329 Mrs. Jennifer Quintana Vol#: 3

EC 330 Miss jeanie summers Vol#: 3

EC 331 Miss Kati Hamm Vol#: 3

EC 332 none Vol#: 3

EC 333 Mrs. Amy Tuttle Vol#: 3

EC 334 Ms. Nicole Discenza Vol#: 3

EC 335 Mrs. Julie Boehning Vol#: 4

EC 336 Ms. Kim McCarthy Vol#: 3

EC 337 Mrs. Alison Needham Vol#: 3

EC 338 Mr. Justin Grenier Vol#: 3

EC 339 Ms. Lanell Bridenbaugh Vol#: 3

EC 340 Mrs. Cathleen Magee Vol#: 3

EC 341 Mrs. Lynn Bell Vol#: 3

EC 342 International Network for History of Pub Vol#: 3

EC 343 Mrs. M.I.H. Gelder Vol#: 3

EC 344 Ms. Brittany Tanner Vol#: 3

EC 345 Mrs. Eileen Lenney Vol#: 3

EC 346 Ms. Catherine Tucker Vol#: 3

EC 347 Mrs. Kathryn Kissane Vol#: 3

EC 348 Mrs. Erin Northington Vol#: 3

EC 349 Mrs. Melissa Herron Vol#: 3

EC 350 Mr. Scott Jesmore Vol#: 3

EC 351 Ms. Kyra Lee Vol#: 3

02P-0493 Anti-heart burn drug Omeprazole magnesium (brand Prilosec1)

ACK 1 HFA-305 Vol#: 1

CP 1 Andrx Pharmaceuticals Corp. Vol#: 1