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 September 27, 2000

TABLE OF CONTENTS

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90P-0201 Optimum size & Style of print to be used to label OTC Drugs *
91N-0098 Dietary Fiber & Cancer, Health Claims & Label Statements *
94D-0325 ICH; Impurities in New Drug Substances; Availability *
95N-0259 Over the Counter Drug Labeling; Public Hearing *
96D-0009 Impurities in new drug products guideline *
00D-1306 Content & Format of Prescription Drug Labeling *
00D-1318 Chronic Cutaneous Ulcer/Burn Wounds--Products for Treatment *
00D-1335 Allergic Rhinitis: Clinical Development Programs for Drug *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1535 Biopsy forceps covers/non-electric biopsy as Class I devices *
00V-1544 Laser Light Show *

83N-0193 Classification of breathing frequency monitor

NWL 1 Vol#: 7

90P-0201 Optimum size & Style of print to be used to label OTC Drugs

C 75 Cosmetic Toiletry & Fragance Assn (CTFA) Vol#: 8

C 76 Consumer Healthcare Products Assn (CHPA) Vol#: 8

91N-0098 Dietary Fiber & Cancer, Health Claims & Label Statements

Linked comments below duplicates those for 91N-0101 and 91n-0103, also below

SUP 2 Emord & Associates P C Vol#: 20
 
 

91N-0101 Antioxidant Vitamins & Cancer,Hlth. Claims & Label Statement

SUP 3 Emord & Associates P C Vol#: 46
 
 

91N-0103 Fatty Acids & Heart Disease, Hlth.Claims & Label Statements

SUP 3 Emord & Associates P C Vol#: 58

94D-0325 ICH; Impurities in New Drug Substances; Availability

C 7 Merck & Co, Inc. Vol#: 1

C 8 Pharmacia Corp. Vol#: 1

C 9 IAGIM, Intl. Assn. of Generic & Innovati Vol#: 1

C 10 IAGIM, Intl. Assn. of Generic & Innovati Vol#: 1

C 11 Otsuka America Pharmaceutical, Inc. Vol#: 1

C 12 AstraZeneca Pharmaceuticals LP Vol#: 1

CR 1 Otsuka America Pharmaceutical, Inc. Vol#: 1

EMC 1 Boehringer Ingelheim Vol#: 1

95N-0259 Over the Counter Drug Labeling; Public Hearing

Linked comments below also duplicate those for 96n-0420, also below

C 21 Cosmetic Toiletry & Fragance Assn (CTFA) Vol#: 13

C 22 Consumer Healthcare Products Assn (CHPA) Vol#: 13

96D-0009 Impurities in new drug products guideline

C 9 Glaxo Wellcome, Inc. Vol#: 1

C 10 Otsuka America Pharmaceutical, Inc. Vol#: 1

C 11 AstraZeneca Pharmaceuticals LP Vol#: 1

CR 1 Otsuka America Pharmaceutical, Inc. Vol#: 1

EMC 1 Boehringer Ingelheim Vol#: 1
 

96N-0420 OTC Human Drugs; Proposed Labeling Requirements

C 1027 Cosmetic Toiletry & Fragance Assn (CTFA) Vol#: 25

C 1028 Consumer Healthcare Products Assn (CHPA) Vol#: 25
 
 

98N-0337 Over the counter human drugs labeling requirements

ANS 9 HFD-560 to Johnson & Johnson Merck Vol#: 6

C 7 Cosmetic Toiletry & Fragance Assn (CTFA) Vol#: 6

C 8 Consumer Healthcare Porducts Assn (CHPA) Vol#: 6

00D-1306 Content & Format of Prescription Drug Labeling

C 10 Bristol-Myers Squibb Pharm. Res. Inst. Vol#: 1

C 11 Merck & Co., Inc. Vol#: 1

C 12 Boehringer Ingelheim Pharm., Inc. Vol#: 1

C 13 Aventis Pharmaceuticals Inc. Vol#: 1

EMC 1 APhA Vol#: 1

EMC 2 Blue Cross & Blue Shield Assn. Vol#: 1

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

C 16 Pfizer Inc Vol#: 2

00D-1335 Allergic Rhinitis: Clinical Development Programs for Drug

C 2 AstraZeneca Pharmaceuticals LP Vol#: 1

C 3 Glaxo Wellcome Research and Development Vol#: 1
 
 

00D-1458 Infant/Child Apnea Monitor 510(K)Submissions

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1
 
 

00F-0812 "Inhibitor of yeast", for the safe of (DMDC)

NFL 2 Bayer Company Vol#: 1
 
 

00N-1457 Medical Devices; Apnea Monitor; Special Controls

NPR 1 Vol#: 1

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

C 6206 Phyllis Bourgeau Vol#: 268

C 6207 Laura Kaye Vol#: 268

C 6208 J. Wilkinson Vol#: 268

C 6209 Jeanette Schuler Vol#: 268

C 6210 Steve Wooden Vol#: 268

C 6211 Angela Lyubarsky Vol#: 268

C 6212 Christa Tinari Vol#: 268

C 6213 Erin Emage Ligros Vol#: 268

C 6214 Nina Gimond Vol#: 268

C 6215 M. Offenberg Vol#: 268

C 6216 Morgan Handerson Vol#: 268

C 6217 M. Dwyer Vol#: 268

C 6218 M. Grych Vol#: 268

C 6219 Catherine Freels Vol#: 268

C 6220 David J. Lyons Vol#: 268

C 6221 Gloria Siegel Vol#: 268

C 6222 Tammy Apana Vol#: 268

C 6223 A. Kahn Vol#: 268

C 6224 Noel Jones Vol#: 268

C 6225 Judith Elliot Vol#: 268

C 6226 Robert Lerman Vol#: 268

C 6227 Maggie Murrane Vol#: 268

C 6228 Mary Sudbrink Vol#: 268

C 6229 Kurt Blum Vol#: 268

C 6230 Mary Sudbrink Vol#: 268

C 6231 Nick Trinen Vol#: 268

C 6232 Philip Silva Vol#: 268

C 6233 Patricia Black Vol#: 268

C 6234 Silvano A. Franca Vol#: 268

C 6235 Patricia Armstrong Vol#: 268

C 6236 Wendy Carlson Vol#: 268

C 6237 Anthony Harshing Vol#: 268

C 6238 no signature Vol#: 268

C 6239 Susan Westwood Vol#: 268

C 6240 Laura Kiel Vol#: 268

C 6241 Barbara Perkins Vol#: 268

C 6242 Joane Clark Vol#: 268

C 6243 Janie Rogers Vol#: 268

C 6244 Diana Hendricks Vol#: 268

C 6245 Adele Rolider Vol#: 268

C 6246 Norma Rorex Vol#: 268

C 6247 Peggy Proiet Vol#: 268

C 6248 Tina Hefter Vol#: 268

C 6249 Gayne P. Schmidt Vol#: 268

C 6250 Sue Tanner Vol#: 268

C 6251 Alice Hervey Vol#: 268

C 6252 Rev. Tim Byington Vol#: 268

C 6253 Bobbie Burney Vol#: 268

C 6254 C. T. Sherman Vol#: 268

C 6255 Mary K. Martin Vol#: 268

C 6256 Gayle J. Silberporn Vol#: 268

C 6257 Nell Denton Vol#: 268

C 6258 Frances Pelton Vol#: 268

C 6259 Elaine Maynard Vol#: 268

C 6260 Lucy Holler Vol#: 268

C 6261 Mary Blassingame Vol#: 268

C 6262 llegible Vol#: 268

C 6263 Wolfgang Hovning Vol#: 268

C 6264 Nicolee Miller-McMahon Vol#: 268

C 6265 Jill Franklin Vol#: 268

C 6266 Ming Zzng Vol#: 268

C 6267 Deborah & Frank Guering Vol#: 268

C 6268 Monica Yurkanin Vol#: 268

C 6269 Ms. Marian Rodriguez Vol#: 268

C 6270 Noel Jones Vol#: 268

C 6271 Jan Jacobson Vol#: 268

C 6272 R. L. Wilson Vol#: 268

C 6273 Betty Fowles Vol#: 268

C 6274 D. L. Casey Vol#: 268

C 6275 Lori E. Krasner Vol#: 268

C 6276 Mary Stucker Vol#: 268

C 6277 Trish Poynor Vol#: 268

C 6278 Cheryl Gordon Vol#: 268

C 6279 Betty Dabbah Vol#: 268

C 6280 Ruth Duty Vol#: 268

C 6281 Jim Yarbrough Vol#: 268

C 6282 Don & Gayle Rogalske Vol#: 268

C 6283 Bonnie Sonder Vol#: 268

C 6284 Glenda M. Jeffries Vol#: 268

C 6285 Arline S. Corcoran Vol#: 268

C 6286 Denise Jachymowski Vol#: 268

C 6287 Fay Haralam Vol#: 268

C 6288 Denise Jachymowski Vol#: 268

C 6289 Chris Cassidy Vol#: 268

C 6290 Jennifer Mollett Vol#: 268

C 6291 Ruby Westcoat Vol#: 268

C 6292 Vivian Steiner Vol#: 268

C 6293 J. Peton Vol#: 268

C 6294 Gioranan Vecchitto Vol#: 268

EMC 2729 Ellen Salassi Vol#: 269

EMC 2730 Linda Larkin Vol#: 269

EMC 2731 Martha Galan Vol#: 269

EMC 2732 Carrie Tucker Vol#: 269

EMC 2733 Sheryn Stout Vol#: 269

EMC 2734 Dick Burrows Vol#: 269

EMC 2735 Janine Swank Vol#: 269

EMC 2736 Pat Schoenecker Vol#: 269

EMC 2737 Timothy White Vol#: 269

EMC 2738 Dottie Koontz Vol#: 269

EMC 2739 Dr. Dorothy K. Cinquemani Vol#: 269

EMC 2740 Jeanne Prevett Vol#: 269

EMC 2741 Nancy H. Ferraro Vol#:

EMC 2742 Elizabeth Okenfuss Vol#: 269

EMC 2743 Lezlie Lee Vol#: 269

EMC 2744 Amy Meyer Vol#: 269

EMC 2745 Ellen Metropole Vol#: 269

EMC 2746 Inese Holte Vol#: 269

EMC 2747 James Hodge Vol#: 269

EMC 2748 Cheri Smith Vol#: 269

EMC 2749 Betty Ball Vol#: 269

EMC 2750 Lynn Hays Vol#: 269

EMC 2751 Nancy Hirschfeld Vol#: 269

EMC 2752 Jeff Bennett Vol#: 269

EMC 2753 Sally Fox Vol#: 269

EMC 2754 Andrew Millard Vol#: 269

EMC 2755 Venetia Pimley Vol#: 269

EMC 2756 Bebo Baldan Vol#: 269

EMC 2757 Dr. Richard Kranzdorf Vol#: 269

EMC 2758 Isabelle Rogers Vol#: 269

EMC 2759 Rebecca Johnson Vol#: 269

EMC 2760 Michelle Knijnenburg Vol#: 269

EMC 2761 David Lichty Vol#: 269

EMC 2762 Joey Green Vol#: 269

EMC 2763 DaLee Siders Vol#: 269

EMC 2764 Cindy Thompson Vol#: 269

EMC 2765 Donna Hoaglin Vol#: 269

EMC 2766 Coleen Atchley Vol#: 269

00P-1535 Biopsy forceps covers/non-electric biopsy as Class I devices

ACK 1 HFA-305 Vol#: 1

00V-1544 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Kira LLC Vol#: 1