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 14, 2001

TABLE OF CONTENTS

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75N-183H Health-Care Antiseptic Drug Products for OTC Human Use *
76N-0482 Estab of Monograph for OTC Topical Antibiotic Products *
80N-0042 Anticaries Drug Products for OTC Human Use *
94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims *
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs *
97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD *
97P-0210 Endolymphatic shunt tube with valve change in classification *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
98N-0337 Over the counter human drugs labeling requirements *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
99P-5106 Identify Sources of Natural Flavorings *
99P-5198 Request amendment of the definition of milk *
00D-1318 Chronic Cutaneous Ulcer/Burn Wounds--Products for Treatment *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-0586 Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz *
00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d *
00P-1322 Food Labeling and Allergen Contamination Control *
01D-0220 Biological Prod Deviation Reporting for Blood & Plasma Estab *
01D-0221 Biological Product Deviation Reporting for Licensed Manufact *
01D-0286 In Vitro HIV Drug Resistance Genotype Assays [510(k)s] *
01D-0311 Class II Special Control Endolymphatic Shunt Tube With Valve *
01D-0368 Submitting Marketing Applications according to ICH/CTD Forma *
01N-0284 Regulation for establishing import tolerances *
01N-0423 Substances Prohibited from use in animal food/Feed Ruminant *
01N-0459 Food Labeling; Notification Procedures on Dietary Supplement *
01P-0250 Dissemination of Non-Misleading Information/Off-Label Uses *
01P-0253 Include Chewing Gum as a Delivery System for the Release of *
01P-0291 ANDA suitability for topical cream containing 5% lidocaine *
01P-0518 X-radiation Emissions *
75N-183H Health-Care Antiseptic Drug Products for OTC Human Use

LET 22 HFD-560 to Lonza, Inc. Vol#: 60

76N-0482 Estab of Monograph for OTC Topical Antibiotic Products

ACK 1 HFA-305 Vol#: 5

CP 7 Dr. Leslie S. Aufseeser Vol#: 5

80N-0042 Anticaries Drug Products for OTC Human Use

PDN 7 HFC-1 to Colgate-Palmolive Company Vol#: 36

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

C 2212 CSPI Vol#: 64

96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs

LET 4 Ctr for Food Science in the Public Inter Vol#: 31

97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD

C 34 Puget Sound Blood Center Vol#: 1

C 35 Aventis Bio Services Vol#: 1

97P-0197 Require that warning labels about risks of salmonella enteri

LET 3 Ctr for Food Science in the Public Inter Vol#: 30

97P-0210 Endolymphatic shunt tube with valve change in classification

C 1 Hood Laboratories, Inc. Vol#: 1

97S-0162 30-Day Structure Function Claim Notification Letters Dietary

LET 8295 NBTY Inc Vol#: 62

LET 8296 NBTY Inc Vol#: 62

98N-0337 Over the counter human drugs labeling requirements

APP 32 Thursday Plantation Laboratories Ltd Vol#: 8

WDL 1 L Perrigo Company Vol#: 8

98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell

LET 3 Ctr for Food Science in the Public Inter Vol#: 32

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

C 5286 J. A. Hyra Vol#: 180

C 5287 Charlotte B. Van Winkle Vol#: 180

C 5288 Ewa Arrajid Vol#: 180

C 5289 Karen A. Ferraro Vol#: 180

C 5290 Janet Van Auken Vol#: 180

C 5291 Arthur W. Schmidt Vol#: 180

C 5292 M. Isabel Silva Vol#: 180

C 5293 Samuel Hernandez Chang IV Vol#: 180

C 5294 Elizabeth Pallesen Vol#: 180

C 5295 Helene Martel Vol#: 180

C 5296 Janet M. Ayward Vol#: 180

C 5297 Joyce Appelbaum Vol#: 180

C 5298 Mrs. Anne Vale Vol#: 180

C 5299 Kenneth Jones Vol#: 180

C 5300 Sharon Speck Vol#: 180

C 5301 Norma Jones Vol#: 180

C 5302 Gloria S. Feldscher Vol#: 180

C 5303 Bev Suminski Vol#: 180

C 5304 Gail Huber Vol#: 180

C 5305 Sherrie Shown Vol#: 180

C 5306 Denyse Miller Vol#: 180

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 3426 Jean McGraw Vol#: 211

C 3427 Rebecca Weisser Vol#: 211

C 3428 Trudi G. Howell Vol#: 211

C 3429 Ann L. Moretto Vol#: 211

C 3430 Julie Ford-Maloney Vol#: 211

C 3431 William Henry Eger, MD Vol#: 211

C 3432 Karen Tarapata Vol#: 211

C 3433 Karen Stevens Vol#: 212

C 3434 Michael Stroud Vol#: 212

C 3435 Laurie Schultz Vol#: 212

C 3436 Paul D. Nelson Vol#: 212

C 3437 Elizabeth Sterenberg Shulman, PhD Vol#: 212

C 3438 Lois E. Reynolds Vol#: 212

C 3439 5 signatures Vol#: 212

C 3440 Cindy D. Stern Vol#: 212

C 3441 Karen Wickham Vol#: 212

C 3442 Edwin Price Vol#: 212

C 3443 John & Alexandra Ballantine Vol#: 212

C 3444 G. Hammond Vol#: 212

C 3445 Sol & Dr. Carol Fineblum Vol#: 212

C 3446 Maria Bachich Vol#: 212

C 3447 Hester Handforth Vol#: 212

C 3448 Jacob McGee Vol#: 212

C 3449 Mary Brenneman, MD Vol#: 212

C 3450 Nancy Lill Vol#: 212

C 3451 Brent Larsen Vol#: 212

C 3452 R. Kiffin Hope Vol#: 212

C 3453 Jake Pegg Vol#: 212

C 3454 Jennifer L. Moore Vol#: 212

C 3455 Laura Smith Vol#: 212

C 3456 James M. Nordlund Vol#: 212

C 3457 Joanna Bagatta Vol#: 212

C 3458 Dr. Andrew C. Millard Vol#: 212

C 3459 Ortrud Carstens Vol#: 212

C 3460 Ortrud Carstens Vol#: 212

C 3461 Demelza Costa Vol#: 212

C 3462 Melissa Kizior Vol#: 212

C 3463 Marian Carter Vol#: 212

C 3464 Craig Melby Vol#: 212

C 3465 Paul & Judy Wilcox Vol#: 212

C 3466 Patricia Lebaron Vol#: 212

C 3467 Mary Ann Street Vol#: 212

C 3468 Rose Leroe Vol#: 212

C 3469 Frances O. Scott Vol#: 212

C 3470 S. Momoon Vol#: 212

C 3471 Jeff Brotemarble Vol#: 212

C 3472 Dorelen Buntine Vol#: 212

C 3473 Nancie Sailor Vol#: 212

C 3474 John & Frances McGarry Vol#: 212

C 3475 No signature Vol#: 212

C 3476 Eligible Vol#: 212

C 3477 Jack & Sharon Cody Vol#: 212

C 3478 Joyce Stoffers Vol#: 212

C 3479 William E. Dilday Vol#: 212

C 3480 Simeon Locke Vol#: 212

C 3481 Jane Robertson Vol#: 212

C 3482 Doreen J. Renner Vol#: 212

C 3483 Joan Romeo Vol#: 212

C 3484 Mary Ellen Tang Vol#: 212

C 3485 Fatima Goldman Vol#: 212

C 3486 Samuel Simkin Vol#: 212

C 3487 Richard B. Kemp Vol#: 212

C 3488 Ruth Boyle Vol#: 212

C 3489 Catherine M. O'Leary Vol#: 212

C 3490 June S. Shepard, PhD Vol#: 212

C 3491 Form Letter Vol#: 213

99P-5106 Identify Sources of Natural Flavorings

C 13 Yvonne & Washington Lezcano Vol#: 2

99P-5198 Request amendment of the definition of milk

C 2 Kevin Waryanka Vol#: 1

99V-4931 Laser Scenic Element

VRA 2 HFZ-300 to Walt Disney Theatrical Produc Vol#: 1

00D-1277 Fumonisin Levels in Human Foods and Animal Feed

GDL 2 GUIDANCE Vol#: 4

NAD 2 Vol#: 4

00D-1318 Chronic Cutaneous Ulcer/Burn Wounds--Products for Treatment

C 17 DHHS/PHS/NIH Vol#: 2

00D-1538 Electronic Records; Electronic Signatures, Validation

C 1 Bruce L. Hogle Vol#: 5

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9138 St. Francis of Assisi Convent Vol#: 401

C 9139 Mary Fineran + 4 signatures Vol#: 401

C 9140 K. Menon Vol#: 401

C 9141 Marie B. Olwell, D.Min. Vol#: 401

00P-0586 Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz

C 28 Kevin Waryanka Vol#: 2

00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d

C 15 MB Multi Bene Health Oy, Ltd Vol#: 17

C 16 CSPI Vol#: 17

00P-1276 Health Claim: Plant stanol esters and heart disease

C 18 MB Multi Bene Health Oy Ltd. Vol#: 17

C 19 CSPI Vol#: 17

00P-1322 Food Labeling and Allergen Contamination Control

C 479 Stonewall Enterprises, Inc. Vol#: 29

C 480 Barbara A. Gardner Vol#: 29

00P-1499 Remove alosetron (Lotronex) from the market

C 185 Ann Meyers Vol#: 5

C 186 Michael F. Elmore, MD Vol#: 5

01D-0220 Biological Prod Deviation Reporting for Blood & Plasma Estab

C 2 America's Blood Centers Vol#: 1

C 3 New York Blood Center Vol#: 1

C 4 Nabi Vol#: 1

C 5 American Red Cross Vol#: 1

01D-0221 Biological Product Deviation Reporting for Licensed Manufact

C 1 Wyeth-Ayerst Laboratories Vol#: 1

C 2 Orange County Regulatory Affairs Vol#: 1

C 3 American Red Cross Vol#: 1

C 4 Hogan & Hartson Vol#: 1

C 5 PDA Vol#: 1

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

C 7 Celera Diagnostics Vol#: 1

01D-0311 Class II Special Control Endolymphatic Shunt Tube With Valve

C 1 Hood Laboratories, Inc. Vol#: 1

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

C 6 GlaxoSmithKline Vol#: 1

01N-0284 Regulation for establishing import tolerances

C 2 Cirila Cerilo Vol#: 1

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

CH 9 The National Chicken Council Vol#: 1

01N-0459 Food Labeling; Notification Procedures on Dietary Supplement

C 1 Congress of the United States Vol#: 1

01P-0169 Access & Safe Distribution of Alosetron

C 108 Ann Myers Vol#: 3

01P-0250 Dissemination of Non-Misleading Information/Off-Label Uses

C 1 Coalition for Healthcare Communication Vol#: 1

01P-0253 Include Chewing Gum as a Delivery System for the Release of

LET 1 HFC-1 to McDermott, Will & Emery Vol#: 1

01P-0291 ANDA suitability for topical cream containing 5% lidocaine

AMD 1 Ferndale Laboratories, Inc. Vol#: 1

01P-0518 X-radiation Emissions

ACK 1 HFA-305 Vol#: 1

CP 1 Consumer Electronic Assn Vol#: 1