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DOCKETS ENTERED on November 22, 2000

TABLE OF CONTENTS

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76N-052H OTC Antihistamine Drug Products *
92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992 *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
00A-1635 Pharmacological Studies - Disability Antidiscrimination *
00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *

76N-052H OTC Antihistamine Drug Products

C 230 Warner Lambert Vol#: 40

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

TR 1 FDA Part 15 Hearing 10/27/00 Vol#: 7

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

C 3008 Laura McAllister Vol#: 84

C 3009 Margaret M. Harlin Vol#: 84

C 3010 Gail L. Robinson Vol#: 84

C 3011 Sally Ann Michel Vol#: 84

C 3012 Lynne Mitchell Vol#: 84

C 3013 Roussel Honoret Vol#: 84

C 3014 Ms. Marilyn Lau Vol#: 84

C 3015 Robert J. Buczek Vol#: 84

C 3016 Ms. Diane Schulte Vol#: 84

C 3017 Ms. Vera E. Larson Vol#: 84

C 3018 Mrs. Norma Nelson Vol#: 84

C 3019 Margaret Cloney Vol#: 84

C 3020 Jan Kemmerer Vol#: 84

C 3021 Ralph Waldron Vol#: 84

C 3022 Patricia Stapleton Vol#: 84

C 3023 Ms. Arlette L. Mann Vol#: 84

99D-1020 (OTC) Screening Tests for Drugs of Abuse guidance for premar

GDL 1 Guidance Vol#: 1

NAD 1 Vol#: 1

99N-0035 Medical Devices; Reclassification of 38 Preamendments

NEC 2 HFZ-215 Vol#: 2

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

C 16317 Harland Smith Vol#: 479

C 16318 Mary Comrie Vol#: 479

C 16319 Kathryn A. Barry Vol#: 479

C 16320 Fredi S. Fleener Vol#: 479

C 16321 Shirley Darnell Vol#: 479

C 16322 Mrs. Paula Kropelin Vol#: 479

C 16323 Mrs. P. D. Brohm Vol#: 479

C 16324 Gayle P. McCloskey Vol#: 479

C 16325 Ken Midbuff Vol#: 479

C 16326 Wanda L. Newberry Vol#: 479

C 16327 Mary Dempsey Lau Vol#: 479

C 16328 Eileen Noall Vol#: 479

C 16329 Bonnie K. & David L. Houck Vol#: 479

C 16330 Dr. & Mrs. Avtar Moore Vol#: 479

C 16331 Mary Meyers Vol#: 479

C 16332 Harry J. Maiberger Vol#: 479

C 16333 Faith Donoghue Vol#: 479

C 16334 Jane Brush Vol#: 479

C 16335 Judith A. Spoan Vol#: 479

C 16336 Susan Steele Vol#: 479

C 16337 James M. Gamble Vol#: 479

C 16338 Amy Howell Mahoney Vol#: 479

C 16339 Mary Janice J. Eppinger Vol#: 479

C 16340 Jack & Miriam W. Parker Vol#: 479

C 16341 Thomas H. R. Pepper Vol#: 479

C 16342 John Peterson Vol#: 479

C 16343 Mary T. Head Vol#: 479

C 16344 Rachel Tolmacs Vol#: 479

C 16345 Heather Foster Vol#: 479

C 16346 Ms. Wanda L. Dolzenko Vol#: 479

C 16347 Susan Chavis Vol#: 479

C 16348 Phyllis Smith Vol#: 479

C 16349 Joseph C. Sackie Vol#: 479

C 16350 Grace M. Brewer Vol#: 479

C 16351 Dr. Phil Nuernberger Vol#: 479

C 16352 Mary Core Kendall Vol#: 479

C 16353 Ms. Beulah Clem Vol#: 479

C 16354 Hannah Ziegellaub Vol#: 479

C 16355 Marc Blackeney Vol#: 479

C 16356 Norman W. Loy Vol#: 479

C 16357 Judi Warrix Vol#: 479

C 16358 Rea Webb Vol#: 479

C 16359 Paula M. Ransone Vol#: 479

C 16360 no signature Vol#: 479

C 16361 Denise Cousino Vol#: 479

C 16362 William J. Breed Vol#: 479

C 16363 Marlene Grover Vol#: 479

C 16364 Suzanne Marie Hill Vol#: 479

C 16365 Stefania Hollay Vol#: 479

C 16366 Allen W. Miller Vol#: 479

C 16367 Melissa E. Knapp Vol#: 479

C 16368 Bonnie A. Kissel Vol#: 479

C 16369 Helen B. Twitchell Vol#: 479

C 16370 Kathy A. Coldium Vol#: 479

C 16371 Nancy Dagle Vol#: 479

C 16372 Diana Pavlick Vol#: 479

C 16373 Donna Kay Christianson Vol#: 479

C 16374 Mary F. Maupim Vol#: 479

C 16375 Harold D. Nichols Vol#: 479

C 16376 Melissa Fay McNeil Vol#: 479

C 16377 Mursy A. Nicholson Vol#: 479

C 16378 Madge Eggena Vol#: 479

C 16379 Margo & Alan Chase Vol#: 479

C 16380 Sandy Allen Vol#: 479

C 16381 Mrs. Jo Ann Smiske Vol#: 479

C 16382 C. Holzhausen Vol#: 479

C 16383 Margery Hall Vol#: 479

C 16384 Annabelle Tavernier Vol#: 479

C 16385 MRB Thornton Vol#: 479

C 16386 Ms. Leslie Seff Vol#: 479

C 16387 Phyllis R. Nelson Vol#: 479

C 16388 Michael G. Smith Vol#: 479

C 16389 Michele Diane Owen Vol#: 479

C 16390 Mary A. Jones Vol#: 479

C 16391 Elaine Huber Vol#: 479

C 16392 Mark Thompson Vol#: 479

C 16393 Donna L. Fillman Vol#: 479

C 16394 Vickie E. Martz Vol#: 479

C 16395 Joy Judith McFarland Vol#: 479

C 16396 Sunny Follis Vol#: 479

C 16397 Barbara B. Janay Vol#: 479

C 16398 Evelyn H. McGough Vol#: 479

C 16399 Ronald A. Johnson Vol#: 479

C 16400 Jennifer Higginbottom Vol#: 479

C 16401 Sandra M. Mahoney Vol#: 479

C 16402 Virgil L. Miller Vol#: 479

C 16403 Ms. Mildred Hecht Vol#: 479

C 16404 Mrs. J. D. Bean Vol#: 479

C 16405 Helen Elizabeth Johnson Vol#: 479

C 16406 Pat, Rene, Dillon Reilly Vol#: 479

C 16407 J. Secciani Vol#: 479

C 16408 Veronica Schmid Vol#: 479

C 16409 Mrs. Irene Litwin Vol#: 479

C 16410 Sherri Bohan Vol#: 479

C 16411 Karoline Krohs Vol#: 479

C 16412 Dick Shaw Vol#: 479

C 16413 Betsy L. Steele Vol#: 479

C 16414 Patricia Mercado Vol#: 479

C 16415 Jeff Hinckley Vol#: 479

C 16416 Lola A. DeVries Vol#: 479

C 16417 Milan Maruska Vol#: 479

C 16418 Crystal Joy Speitz Vol#: 479

C 16419 Olive M. Wolters Vol#: 479

C 16420 Hazel M. Dewey Vol#: 479

C 16421 Pat Mattes Vol#: 479

00A-1635 Pharmacological Studies - Disability Antidiscrimination

ACK 1 HFA-305 Vol#: 1

AP 1 Advocacy, Incorporated Vol#: 1

00D-1555 Refusal of Inspection or Access to HACCP recods pertaining

GDL 1 Guidance Vol#: 1

NAD 1 Vol#: 1

00D-1557 Indwelling Blood Gas Analyzer 510(k)

GDL 1 Guideline Vol#: 1

NAD 1 HFZ-215 Vol#: 1

00D-1558 Electrical Safety, Electromagnetic Capatibility & Mech Test

GDL 1 Guideline Vol#: 1

NAD 1 HFZ-215 Vol#: 1

00D-1566 Class II Special Control/Antibody PMA Notifications

GDL 1 Guideline Vol#: 1

NAD 1 HFZ-215 Vol#: 1

00D-1587 Medical Devices Guidance for Prescription Drugs Abuse Assays

GDL 1 Guidance Vol#: 1

NAD 1 Vol#: 1

00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal

C 45 Susan Biesek Vol#: 15

C 46 Gronec & Latham Vol#: 15

C 47 National Consumers League Vol#: 15

C 48 Stanislaus Food Products Inc Vol#: 15

C 49 CSPI Vol#: 15

EMC 141 Lamar Schoonmaker Vol#: 15

EMC 142 Peter Gonzalez Vol#: 15

EMC 143 Natn'l Juice Products Assn Vol#: 15

EMC 144 Tropicana Products Inc Vol#: 15

EMC 145 Peter Nolan Vol#: 15

EMC 146 Del Monte Foods Corp Vol#: 15

00N-1565 Classification of Anti-Saccharomyces cerevisiae in Class II

NFR 1 HFZ-215 Vol#: 1

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

EMC 3708 Jane Gerald Vol#: 342

EMC 3709 Hillary Stainthorpe Vol#: 342

EMC 3710 Jonathan Janssen Vol#: 342

EMC 3711 James Ward Vol#: 342

EMC 3712 hambe004@tc.umn.edu Vol#: 342

EMC 3713 Sharon Michaud Vol#: 342

EMC 3714 Carl Adams Vol#: 342

EMC 3715 Phil Ruckrich Vol#: 342

EMC 3716 Butt Sex Vol#: 342

EMC 3717 Jodi Friedlander Vol#: 342

EMC 3718 Irina Branzburg Vol#: 342

EMC 3719 Ulysses J Foobar Vol#: 342

EMC 3720 Bobby Dutton Vol#: 342

EMC 3721 Maura Smith Vol#: 342

EMC 3722 Annie Ray Vol#: 342

EMC 3723 Joseph Moreno Vol#: 342

EMC 3724 Pamela Mills Vol#: 342

EMC 3725 Cara Glennon Vol#: 342

EMC 3726 Paulie Rainbow Vol#: 342

EMC 3727 Shari Belanger Vol#: 342

EMC 3728 Ann Hunt Vol#: 342

EMC 3729 Valerie Jungen Vol#: 342