Food and Drug Administration Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, 

Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870

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DOCKETS ENTERED on August 10, 2000

TABLE OF CONTENTS

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91N-0098 Dietary Fiber & Cancer, Health Claims & Label Statements *
96N-0393 MedWatch:FDA's Medical Prod Reporting Program Forms; Agency *
00D-1407 Safety Pharmacology Studies for Human Pharmaceuticals *
00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1245 ANDA for Nizatidine Capsules, 75mg *
00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d *
00P-1443 Alendronate Sodium Tablets *
00V-0570 Laser Light Show *
00V-1442 *

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

THIS LINKED COMMENT DUPLICATES THOSE FOR 91N-0101, -0103, -0100H; AND 99D-5424, ALSO BELOW.

SUP 1 Emord & Associates P C Vol#: 20

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

SUP 2 Emord & Associates P C Vol#: 40
 
 

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

SUP 2 Emord & Associates P C Vol#: 29
 
 

91N-100H Health Claims & Label Statements; Folate & Neural Tube Defec

SUP 1 Emord & Associates P C Vol#: 11
 
 

96M-0311 Guideline on Infectious Disease Issues in Xenotransplantatio

C 168 Novartis Pharmaceuticals Corp Vol#: 20

96N-0393 MedWatch:FDA's Medical Prod Reporting Program Forms; Agency

C 25 FDA New Jersey District Office Vol#: 1
 
 

97C-0415 Amend Regulations to Provide the Safe Use of Zinc Sulfide

BKG 1 BACKGROUND MATERIAL Vol#: 1

NFR 1 Vol#: 1
 
 

99D-5424 Health claims for Conventional Foods & Dietary Supplements

SUP 1 Emord & Associates P C Vol#: 1
 
 

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

C 14487 Deborah OKeefe Vol#: 438

C 14488 Edward & Janet Matza Vol#: 438

C 14489 Laurie Cook Vol#: 438

C 14490 Diana Webb Vol#: 438

C 14491 Hilary Hince Vol#: 438

C 14492 Earlene Webster Vol#: 438

C 14493 Patricia Olson Vol#: 438

C 14494 Marlene Campiott Vol#: 438

C 14495 Mary S. Martin Vol#: 438

C 14496 Cynthia Dott Vol#: 438

C 14497 Paul D. Guday Vol#: 438

C 14498 Carol Childs Vol#: 438

C 14499 Kelly A. Martin Vol#: 438

C 14500 Ron & Karen Holler Vol#: 438

C 14501 Rachel Brandenburg Vol#: 438

C 14502 Cynthia A. Uribe Vol#: 438

C 14503 Arlene A. Hallenbeck Vol#: 438

C 14504 Daniela Sylvia Adamezak Vol#: 438

C 14505 Phyllis A. Anderson Vol#: 438

C 14506 Annette & Mike Clark Vol#: 438

C 14507 Gordon Aitken Vol#: 438

C 14508 Jean Salisbury Vol#: 438

C 14509 Debbie Mahoney Vol#: 438

C 14510 Gertrud Aiken Vol#: 438

C 14511 Carole Grubb Vol#: 438

C 14512 Annie Lucky Vol#: 438

C 14513 Duke Stone Vol#: 438

C 14514 Marian Sample Vol#: 438

C 14515 Gregg & Roxanne Marble Vol#: 438

C 14516 Judith Hinckley Vol#: 438

C 14517 Timothy P. Brady Vol#: 438

C 14518 Dale V. & Bobby A. Sarkkinen Vol#: 438

C 14519 Sandra Aultman Vol#: 438

C 14520 David C. Barton Vol#: 438

C 14521 Pat A. Channell Vol#: 438

C 14522 Barbara Kirschenstein Vol#: 438

C 14523 Ruth R. Anderson Vol#: 438

C 14524 Bobby J. Davis Vol#: 438

C 14525 Carrie Cox Bedell Vol#: 438

C 14526 Gretchen Drilling Vol#: 438

C 14527 Stephanie Groll Vol#: 438

C 14528 D. A. Hayes Vol#: 438

C 14529 Edward A. Zink Vol#: 438

C 14530 Mr & Mrs Jeffrey Stoner & Family Vol#: 438

C 14531 William E. Norcott Vol#: 438

C 14532 Brent Anderson Vol#: 438

C 14533 Roland Dean Metcalf Vol#: 438

C 14534 Dolores J. Fincher Vol#: 438

C 14535 Margery Hunter Vol#: 438

C 14536 Jo Ann Miller Vol#: 438

C 14537 Darnell Heverey Vol#: 438

C 14538 Dona Grasseler Vol#: 438

C 14539 Dr. Guy Markham Vol#: 438

C 14540 Shannon D. Dobbins Vol#: 438

C 14541 Karena Youtz Vol#: 438

C 14542 Ann Anderson Vol#: 438

C 14543 Carol A. Deretchin Vol#: 438

C 14544 Edward M. Ames Vol#: 438

C 14545 Dianne R. Cristich Vol#: 438

C 14546 Darrell Wells Vol#: 438

C 14547 Suzanne L. Fournier Vol#: 438

C 14548 Pam Osborn Vol#: 438

C 14549 Keirsten Snoves Vol#: 438

C 14550 Billye Chandler Vol#: 438

C 14551 D. Petersen Vol#: 438

C 14552 Ilse S. Martz Vol#: 438

C 14553 Gail A. Horkman Vol#: 438

C 14554 John W. & Carol Smith Vol#: 438

C 14555 Ryan Holly Vol#: 438
 
 

99P-2630 Establish a Daily Value for "added sugars"

C 128 National Students Nurses' Assoc Inc(NSNA Vol#: 7

00D-1407 Safety Pharmacology Studies for Human Pharmaceuticals

EMC 1 Dennis J Murphy PhD Vol#: 1
 
 

00F-0119 Safe Use of Calcium Disodium EDTA

BKG 1 BACKGROUND MATERIAL Vol#: 1

NFR 1 Vol#: 1
 

00M-1437 Premarket Approval QUS-2 Calcaneal Ultrasonometer

AAV 1 Metra Biosystems Vol#: 1
 
 

00N-1256 Over-the-Counter Drug Products;Public Hearing

CH 236 J C Willke, MD Vol#: 13

CH 237 American Medical Association Vol#: 13

CH 238 Mr. Robert Thompson Vol#: 13

CH 239 NFPRHA Vol#: 13
 
 

00N-1374 Revisions of Certain Food Chemicals Codex Monongraphs

N 1 Vol#: 1

00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop

C 2 Beckman Coulter Vol#: 1

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

C 4093 Lucille Culpepper Vol#: 150

C 4094 Thelma Urich Vol#: 150

C 4095 Tatiana Wrenfeather Vol#: 150

C 4096 Deborah Natera Vol#: 150

C 4097 Kelly A. Schmidt Vol#: 150

C 4098 Diane Ake Vol#: 150

C 4099 John Runkel Vol#: 150

C 4100 Ken Rundel Vol#: 150

C 4101 Heather Kemp Vol#: 150

C 4102 Ginger Metraux Vol#: 150

C 4103 Mary E. Anderson Vol#: 150

C 4104 Maxine Blaine Vol#: 150

C 4105 Dorothy Higdon Vol#: 150

C 4106 Diane Marie Kuc Vol#: 150

C 4107 Lillian Hsu Vol#: 150

C 4108 Joan Asher Vol#: 150

C 4109 Julia Kalamaras Vol#: 150

C 4110 Kristin Eggerling Vol#: 150

C 4111 Danny Pottes Vol#: 150

C 4112 D. Wayne Ratcliffe Vol#: 150

C 4113 Reba Scott Vol#: 150

C 4114 Linda Gilmore Vol#: 150

C 4115 Doris M. Sullivan Vol#: 150

C 4116 Patricia McGill Vol#: 150

C 4117 Paula Hamilton Vol#: 150

C 4118 Mr & Mrs Francis J. Alberto Vol#: 150

C 4119 John H. Donahue Vol#: 150

C 4120 Elaine Congdon Vol#: 150

C 4121 Jeane Spada-Allgood Vol#: 150

C 4122 Eliza Vimmerstedt Vol#: 150

C 4123 Lee Hardison Vol#: 150

C 4124 Sharolyn Smidt Vol#: 150

C 4125 Maria Kniazeva Vol#: 150

C 4126 Danika Murray Vol#: 150

C 4127 Sallie Moore Vol#: 150

C 4128 Christine Krippene Vol#: 150

C 4129 Barbara Troutman Vol#: 150

C 4130 Edward Mass Vol#: 150

C 4131 Alana Reynolds Vol#: 150

C 4132 Susan Wotring Vol#: 150

C 4133 Judith Lee Azaren Vol#: 150

C 4134 Gregory & Lorrie Curtis Vol#: 150

C 4135 M. L. Coleman Vol#: 150

C 4136 Jerry & Maggie Melnick Vol#: 150

C 4137 Jackie Sauriol Vol#: 150

C 4138 Juanita Zenus Vol#: 150

C 4139 Joseph & Donna Robertson Vol#: 150

C 4140 Mr & Mrs Joseph Beals Vol#: 150

C 4141 Jade Martinez Vol#: 150

C 4142 Tina Kahn Vol#: 150

C 4143 B. J. Miller Vol#: 150

C 4144 Janet Piggins Vol#: 150

C 4145 Georgia Rounsaville Vol#: 150

C 4146 Marga Madhuri Vol#: 150

C 4147 Willard B. Myers Vol#: 150

C 4148 Kate Gerritsen Vol#: 150

C 4149 Sharon Goodall Vol#: 150

C 4150 Elaine DeVore Vol#: 150

C 4151 Elizabeth Frost Vol#: 150

C 4152 Gay Chanler Vol#: 150

C 4153 Dr. George Eastman Vol#: 150

C 4154 Deanna Moritz Vol#: 150

C 4155 Marjorie Campaigne Vol#: 150

C 4156 Susan Sullivan Vol#: 150

C 4157 D. Mikkelsen Vol#: 150

C 4158 Jeremy Bowman Vol#: 150

C 4159 Jill Ransom Vol#: 150

C 4160 Carrie Payne Vol#: 150

C 4161 Vicki Keller Vol#: 150

C 4162 Michael Wheeler Vol#: 150

C 4163 Cheryl Irwin Vol#: 150

C 4164 Matt Meyers Vol#: 150

C 4165 Samanatha Ellis Vol#: 150

C 4166 Greg Todd Vol#: 150

C 4167 Shirley O. Carroll Vol#: 150

C 4168 Gail Matthews Vol#: 150

C 4169 Lynn Mandaram Vol#: 150

C 4170 Alice Farber Vol#: 150

C 4171 Mrs. Mary Nanos Vol#: 150

C 4172 Carola V. Cohn Vol#: 150

C 4173 Turay Zaimi Vol#: 150

C 4174 Paula M. Castagna Vol#: 150

C 4175 Gina Sanchione Vol#: 150

C 4176 Christine Colasurdo Vol#: 150

C 4177 Mr & Mrs B. Bullington Vol#: 150

C 4178 Asho Craine Vol#: 150

C 4179 Ruth Siller Vol#: 150

C 4180 Tobi Ricca Vol#: 150

C 4181 Frank Smith Vol#: 150

C 4182 Keith Peters Vol#: 150

C 4183 Michael Garcia Vol#: 151

EMC 1765 Ligia Ercius-DiPaola Vol#: 151

EMC 1766 Hiren Patel Vol#: 151

EMC 1767 Amanda Mourant Vol#: 151

EMC 1768 Olivia Lehman Vol#: 151

EMC 1769 Irene C. Beard Vol#: 151

EMC 1770 Patrisha A. Lowder Vol#: 151

EMC 1771 Beth Baldino-Feehan Vol#: 151

00P-1245 ANDA for Nizatidine Capsules, 75mg

AMD 1 Lachman Consultant Services, inc. Vol#: 1

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

EXT 1 Lipton Vol#: 4

M 1 HFS-832 Vol#: 4
 
 

00P-1343 Reclassify Barium Enema Retention Catheter to Class II

N 1 Vol#: 1

00P-1443 Alendronate Sodium Tablets

ACK 1 HFA-305 Vol#: 1

PSA 1 Zenith Goldline Pharmaceuticals Vol#: 1

00V-0570 Laser Light Show

AMD 1 Pulse Laser Productions Vol#: 1

00V-1442

VAR 1 Yamagata Studio Vol#: 1