Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870 [E-mail Us]

DOCKETS ENTERED on November 8, 2001

TABLE OF CONTENTS

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76N-052N OTC Nasal Decongestants *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-5198 Request amendment of the definition of milk *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-1322 Food Labeling and Allergen Contamination Control *
00P-1550 Approve ANDA for Cefuroxime Axetil Products *
01D-0269 Clinical Studies Section for Prescription Drugs & Biologics *
01D-0286 In Vitro HIV Drug Resistance Genotype Assays [510(k)s] *
01D-0368 Submitting Marketing Applications according to ICH/CTD Forma *
01N-0423 Substances Prohibited from use in animal food/Feed Ruminant *
01P-0345 Listing the color additive yellow #5 for use in food/Drug *
01P-0471 Issue the NFR Placement of Anthrax Vaccine as Category II *
76N-052N OTC Nasal Decongestants

EMC 121 Charol Abrams Vol#: 76

EMC 122 Brenda Rinko Vol#: 76

92V-0286 Variance Request for Mobilazer ML-10A Light Show

VRA 6 HFZ-340 to Mobolazer, Inc. Vol#: 1

96V-0210 Variance for Laser Light Show

VRA 4 HFZ-340 to LaserSmith Light Show Systems Vol#: 1

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

C 5279 Corinne Stras Vol#: 180

C 5280 Marilyn Sue Betman Vol#: 180

C 5281 Mrs. Arline Virgil Vol#: 180

C 5282 Judith Libbey Vol#: 180

C 5283 Victor Furman Vol#: 180

C 5284 Wilhelm Winter Vol#: 180

C 5285 Shirley O'Connor Vol#: 180

EMC 2544 Sharon Speck, LCSW Vol#: 188

EMC 2545 Nella Yelenovic Vol#: 188

EMC 2546 Jade Echagarrua Vol#: 188

EMC 2547 Jade Echagarrua Vol#: 188

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

EMC 294 Sarah M. Richart, PhD Vol#: 43

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

EMC 3490 Tiffany Catalfano Vol#: 505

EMC 3491 Eric Abelson Vol#: 505

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

EMC 870 Penny Howard Vol#: 209

EMC 871 Scott Larson Vol#: 209

99P-1340 Declared Eternity eau de Parfum Misbranded

EMC 342 No signature Vol#: 18

EMC 343 Melanie Moss Vol#: 18

EMC 344 Maureen Shea Vol#: 18

EMC 345 Elizabeth Caldwell Vol#: 18

99P-5198 Request amendment of the definition of milk

EMC 1 Michael Larson Vol#: 1

EMC 2 no signature Vol#: 1

EMC 3 Robert R. MacLeod Vol#: 1

EMC 4 Margaret Davis Vol#: 1

EMC 5 Lew Ricker Vol#: 1

EMC 6 Judith M. Friebert Vol#: 1

EMC 7 S. Kocsis Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9548 12 signatures Vol#: 476

C 9549 Caitlin Burns Vol#: 476

C 9550 Douglas C. MacLatchie Vol#: 476

C 9551 Tom Chorman Vol#: 476

C 9552 Katherine A. Bean Vol#: 476

C 9553 Lynda R. Hartigen Vol#: 476

C 9554 Rachel Horn Vol#: 476

C 9555 Kenneth G. Kelly, PhD Vol#: 476

C 9556 Michelle Catapang Vol#: 476

C 9557 Justin Pasay Vol#: 476

C 9558 Patrick West Vol#: 476

C 9559 Susan Forbes Vol#: 476

C 9560 Traci Mosher Vol#: 476

C 9561 Carl Mayer Vol#: 476

C 9562 Suzanne Barry Vol#: 476

C 9563 Pam Monteleone Vol#: 476

C 9564 Katye Loudermilk Vol#: 476

C 9565 Merle E. Lane Vol#: 476

C 9566 Janet Katz Vol#: 476

C 9567 Robert & Toni Woodford Vol#: 476

C 9568 No signature Vol#: 476

C 9569 No signature Vol#: 476

C 9570 Jim Hingtgen Vol#: 476

C 9571 Grace Pinkham Vol#: 476

C 9572 Jeremy Lite Vol#: 476

C 9573 Nelson Stalcup Vol#: 476

C 9574 Bertina Houghland Vol#: 476

C 9575 Mason Brown Vol#: 476

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9129 Bertina Houghland Vol#: 401

C 9130 Mason Brown Vol#: 401

C 9131 Irl Nelson Stalcup Vol#: 401

C 9132 Presentation Convent Vol#: 401

C 9133 Jesus of the Mountains Church Vol#: 401

C 9134 D. Smith Vol#: 401

EMC 11525 Isobel Schnedier Vol#: 349

EMC 11526 Aline Crehore Vol#: 349

00P-1322 Food Labeling and Allergen Contamination Control

C 473 84 signatures Vol#: 29

C 474 Mark A. Arthur Vol#: 29

C 475 Joyce Luschen Vol#: 29

C 476 James R. Derienzo Vol#: 29

C 477 Susan A. Zdeblick Vol#: 29

C 478 Helen Van Driel Vol#: 29

00P-1550 Approve ANDA for Cefuroxime Axetil Products

C 3 Arnold & Porter Vol#: 2

00V-1382 AIG Limelight 200 & 45 Class IIIB Laser Diode Infrared Illum

VRA 1 HFZ-340 to Electronic Services Agency Vol#: 1

01D-0269 Clinical Studies Section for Prescription Drugs & Biologics

C 3 Wyeth-Ayerst Laboratories Vol#: 1

C 4 PhRMA Vol#: 1

01D-0286 In Vitro HIV Drug Resistance Genotype Assays [510(k)s]

EMC 1 Virco Vol#: 1

EMC 2 Bayer Vol#: 1

EMC 3 American Clinical Laboratory Assn Vol#: 1

EMC 4 American Clinical Laboratory Assn Vol#: 1

01D-0368 Submitting Marketing Applications according to ICH/CTD Forma

C 5 Quintiles, Inc. Vol#: 1

01N-0423 Substances Prohibited from use in animal food/Feed Ruminant

CH 8 U.S. Poultry & Egg Association Vol#: 1

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

EMC 776 Deirdre A. Wilson Vol#: 4

EMC 777 Margaret Cox Vol#: 4

EMC 778 No signature Vol#: 4

01P-0471 Issue the NFR Placement of Anthrax Vaccine as Category II

EMC 11 Frances Coover Vol#: 1

EMC 12 Patricia Burkhardt Vol#: 1

01V-0376 Laser Light Show Mobolazer ML8-20G,Ml8-50RG,ML10-250,ML10-30

VRA 1 HFZ-340 to Solid Productions, Inc. Vol#: 1

01V-0410 Laser Light Show

VRA 1 HFZ-340 to Shooters 21-Warrensburg Vol#: 1

01V-0422

VRA 1 HFZ-340 to Industrial Light & Sound Vol#: 1