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 October 11, 2000

TABLE OF CONTENTS

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91N-0098 Dietary Fiber & Cancer, Health Claims & Label Statements *
00D-0785 GUIDANCE ON MEDICAL DEVICE PATIENT LABELING *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
91N-0098 Dietary Fiber & Cancer, Health Claims & Label Statements

The linked comments below duplicate those for 91N-0101, -0103, and -100H, also below

LET 1 CFSAN Vol#: 26

REF 2 References 1-52 Vol#: 27

SUP 3 Emord & Associates P C Vol#: 26

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

LET 1 CFSAN Vol#: 46

SUP 4 Emord & Associates P C Vol#: 46

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

LET 1 CFSAN Vol#: 58

SUP 4 Emord & Associates P C Vol#: 58

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

LET 2 CFSAN Vol#: 16

REF 1 References 1-38 Vol#: 17

SUP 2 Emord & Associates P C Vol#: 16

98D-0266 Section 121 Positron Emission Tomography (PET) FDAMA

TR 5 Transcript of the July 28, 2000 meeting Vol#: 12

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

EMC 3144 Margaret Clabaugh Vol#: 459

EMC 3145 MTS Vol#: 459

EMC 3146 Emil Bartok Vol#: 459

EMC 3147 Barbara Lagan Vol#: 459

EMC 3148 Moore K2001 Vol#: 459

EMC 3149 Larry Vol#: 459

EMC 3150 Beverly Nelson Vol#: 459

EMC 3151 MJT Vol#: 459

EMC 3152 Susan C. Hixson Vol#: 459

EMC 3153 Julie Moulton Vol#: 459

EMC 3154 Karen Widman Vol#: 459

EMC 3155 B. Brown Vol#: 459

EMC 3156 Michele A. Cunko Vol#: 459

EMC 3157 Betsy Faga Vol#: 459

EMC 3158 Tettle Clawson Vol#: 459

EMC 3159 Debbie Dunbar Ortman Vol#: 459

EMC 3160 Michele A. Cunko Vol#: 459

EMC 3161 Glena L. Young Vol#: 459

EMC 3162 Susan Stern Vol#: 459

EMC 3163 Karah Stokes Vol#: 459

EMC 3164 Rachel Reilly Vol#: 459

EMC 3165 Midge Woizesko Vol#: 459

EMC 3166 Lisa Roth Vol#: 459

EMC 3167 Billie Hobart Vol#: 459

EMC 3168 Mark Kaplan Vol#: 459

EMC 3169 Kathryn Lannon Vol#: 459

EMC 3170 Laura Howard Vol#: 459

EMC 3171 Carla A. Wise Vol#: 459

EMC 3172 Matt Vol#: 459

EMC 3173 Warren Levy Vol#: 459

EMC 3174 Mr & Mrs. M. Jerry Miller Vol#: 459

EMC 3175 Barbara Boxer Vol#: 459

EMC 3176 Jane Clark Vol#: 459

EMC 3177 T. Brown Vol#: 459

EMC 3178 Lorrie Ogren Vol#: 459

EMC 3179 Billie Williams Vol#: 459

EMC 3180 Catherine Burke Vol#: 459

EMC 3181 Patricia Novak Vol#: 459

EMC 3182 Denise Moser Vol#: 459

EMC 3183 Tracy Beteta Vol#: 459

EMC 3184 William M. Allan Vol#: 459

EMC 3185 Jan McCreary Vol#: 459

EMC 3186 David Wayne Vol#: 459

EMC 3187 Maggi Draper Vol#: 459

EMC 3188 Kelly Anderson Vol#: 459

EMC 3189 Jeffrey S. Cozy Vol#: 459

EMC 3190 Candace Brandt Vol#: 459

EMC 3191 Trish Tang Vol#: 459

EMC 3192 Paola Vol#: 459

EMC 3193 Rev. B. L. Collins Vol#: 459

EMC 3194 Alan Druckman Vol#: 459

EMC 3195 Susan Hall Vol#: 459

EMC 3196 Diane Rhyne Vol#: 459

EMC 3197 Jennifer Encarnacion Vol#: 459

EMC 3198 Mary Lou Puskar Vol#: 459

EMC 3199 Laura White Vol#: 459

EMC 3200 Deven Murti Vol#: 459

EMC 3201 Ashling P. McAnaney Vol#: 459

EMC 3202 Jessica Jentz Vol#: 459

EMC 3203 Deborah Root-Pfrommer Vol#: 459

EMC 3204 R. A. Martin Vol#: 459

EMC 3205 Christopher Warren Vol#: 459

EMC 3206 Bob McClellan Vol#: 459

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

C 498 number not used Vol#: 25

C 499 David R. Lineback Vol#: 25

C 500 Carolyn F. Wilson Vol#: 25

C 501 Lynn A. Larsen Vol#: 25

C 502 Oldways Preservation & Exchange Trust Vol#: 25

C 503 Pennsylvania Dental Association Vol#: 25

C 504 Union of EU Soft Drinks Association Vol#: 25

C 505 L. Tschuejunor Vol#: 25

C 506 National Consumer League Vol#: 25

C 507 National Yogurt Association Vol#: 25

C 508 Mrs. Winifred R. Hirsch Vol#: 25

C 509 Wendy Myles Vol#: 25

C 510 Marguerite Matthews Vol#: 25

C 511 Lillian Holub Vol#: 25

C 512 National Association of School Nurses Vol#: 25

C 513 Beverly Martin Vol#: 25

C 514 Harvard Center For Population & Dev. Vol#: 25

C 515 Joanne Smith Vol#: 25

C 516 Betty J. Meeks Vol#: 25

C 517 Jayne Cassedis Vol#: 25

C 518 Darin & Wendy Rich Vol#: 25

C 519 J. Prajapati Vol#: 25

C 520 Lisa Symons Vol#: 25

C 521 Pamela Woodbury Vol#: 25

C 522 Cherie Ellery Vol#: 25

C 523 Danielle Gimble Vol#: 25

C 524 Tamara Belland Vol#: 25

C 525 Betse Davies Vol#: 25

C 526 Elizabeth A. DuFrane Vol#: 25

C 527 Lorna Lecrenier Vol#: 25

C 528 Thai Industrial Standards Institute Vol#: 25

C 529 Mrs. Genevieve Monaghan Vol#: 25

C 530 Stephie Schiano Vol#: 25

C 531 Patricia Ohneck Vol#: 25

C 532 Patricia Ohneck Vol#: 25

C 533 European Commission Vol#: 25

EMC 334 Northland Cranberries, Inc. Vol#: 25

EMC 335 David R. Lineback Vol#: 25

EMC 336 Number not used Vol#: 25

EMC 337 Vivian Nichols Vol#: 25

EMC 338 Glen Bradley Vol#: 25

EMC 339 Alisha Rovner Vol#: 25

EMC 340 David Landskov Vol#: 25

EMC 341 Miriam Null Vol#: 25

EMC 342 Elizabeth Riggins Vol#: 25

EMC 343 National Association of WIC Vol#: 25

EMC 344 Oldways Preservation & Exchange Trust Vol#: 25

EMC 345 Michael Miller Vol#: 25

EMC 346 Matt Collins Vol#: 25

EMC 347 Molly Farrington Vol#: 25

EMC 348 Michael Hunt Vol#: 25

EMC 349 Pam Basden Vol#: 25

EMC 350 World Trade Organistation Committee Vol#: 25

EMC 351 Robert D. Byrne Vol#: 25

EMC 352 E. Burtch-Farrell Vol#: 25

EMC 353 World Trade Organistation Committee Vol#: 25

EMC 354 Amy Starchville Vol#: 25

EMC 355 Julia Frank Vol#: 25

EMC 356 Karia Lizardi Vol#: 25

EMC 357 Pennsylvanis Dental Association Vol#: 25

EMC 358 Don Clark Vol#: 25

EMC 359 Kristine Duncan Vol#: 25

EMC 360 Pat Farrell Vol#: 25

EMC 361 Linda Smis Vol#: 25

EMC 362 Joseph Arceneaux Vol#: 25

EMC 363 Emily Swan Vol#: 25

EMC 364 Donald R. Davis Vol#: 25

EMC 365 Ruth Bernstein Vol#: 25

EMC 366 Carolyn Pearsall White Vol#: 25

EMC 367 Carolyn Pearsall White Vol#: 25

EMC 368 Verna Osborn Vol#: 25

EMC 369 David Bryant Vol#: 25

EMC 370 Linda J. Winograd Vol#: 25

EMC 371 William James Harper Vol#: 25

EMC 372 Gloria Vol#: 25

EMC 373 Joyce Schwartz Vol#: 25

EMC 374 Geoff Tischbein Vol#: 25

EMC 375 Lynn Wiech Vol#: 25

EMC 376 Nancy Sullivan Vol#: 25

EMC 377 Kenneth J. Trippel Vol#: 25

EMC 378 Stacy Prince Vol#: 25

EMC 379 Walter & Ruth Nyberg Vol#: 25

00D-0785 GUIDANCE ON MEDICAL DEVICE PATIENT LABELING

EMC 1 Paula G Silberberg Vol#: 1

00N-0085 Food Contact Substance Notification System

NCD 1 HFS-215 Vol#: 1

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

C 6416 Dennis G Miller Vol#: 278

C 6417 Margaret de Rivera Vol#: 278

C 6418 Catherine J Hinchey Vol#: 278

C 6419 Lucy Anderson Vol#: 278

C 6420 Meg Taylor Vol#: 278

C 6421 Brett K Collins Vol#: 278

C 6422 Kurt Nielsen Vol#: 278

C 6423 Vera Marie Taylor Allen Vol#: 278

C 6424 Elizabeth A Hogan Vol#: 278

C 6425 Tom Snyder Vol#: 278

C 6426 Laura Dobbins Vol#: 278

C 6427 Shandor Garrison Vol#: 278

C 6428 Herb Holmes Vol#: 278

C 6429 Charles Jorud Vol#: 278

C 6430 Sophia Suhu Vol#: 278

C 6431 Robert Dreher Vol#: 278

C 6432 Linda Vernon Clark Vol#: 278

C 6433 Rosalie George Vol#: 278

C 6434 Edward A Ross Vol#: 278

C 6435 Jon Gilbert Heiken Vol#: 278

C 6436 M Powers Vol#: 278

C 6437 Ann Kinney-Eittinger Vol#: 278

C 6438 K Cox Vol#: 278

C 6439 Rhio H Coreli Vol#: 278

C 6440 Jean L Padman Vol#: 278

C 6441 Marion Hall Vol#: 278

C 6442 L Sigmond Vol#: 278

C 6443 Jennipher Marrs Vol#: 278

C 6444 John Frazer Vol#: 278

C 6445 Bill Russell Vol#: 278

C 6446 Inge Szues Vol#: 278

C 6447 Irene Cyson Vol#: 278

C 6448 Meghan Adams Vol#: 278

C 6449 Estelle Baldwin Vol#: 278

C 6450 Felicia Novic Vol#: 278

C 6451 Geri Dubie Vol#: 278

C 6452 Bryan Glova Vol#: 278

C 6453 Debbie Combs Vol#: 278

C 6454 Katherine Robbins Vol#: 278

C 6455 Rebecca Minifie Vol#: 278

C 6456 N Graziano Vol#: 278

C 6457 Priscilla Coe Vol#: 278

C 6458 Debra Jones Vol#: 278

C 6459 Patricia Gentile Vol#: 278

C 6460 Joe Resner Vol#: 278

C 6461 Susan Fasten Vol#: 278

C 6462 Debra A McGeorge Vol#: 278

C 6463 Ethel Day Vol#: 278

C 6464 Katherine A Tighe Vol#: 278

C 6465 Martha Bushnell Vol#: 278

C 6466 Martha Bushnell Vol#: 278

EMC 3153 Marvin Rothfusz Vol#: 278

EMC 3154 Stephanie Caughlin Vol#: 278

EMC 3155 Ellie Duram Vol#: 278

EMC 3156 Lelia Ross Vol#: 278

EMC 3157 Ben Taylor Vol#: 278

EMC 3158 Jan Todd Vol#: 278

EMC 3159 Alberto Feliciano Vol#: 278

EMC 3160 Michael Fischer Vol#: 278

EMC 3161 Rob Dinneford Vol#: 278

EMC 3162 Rachael Stidham Vol#: 278

EMC 3163 Nancy Gronewold Vol#: 278

EMC 3164 Janet Eberhardt Vol#: 278

EMC 3165 Michael Kofford Vol#: 278

EMC 3166 Barbara King Vol#: 278

EMC 3167 Robehr Quijano Vol#: 278

EMC 3168 Bari Zwirn Vol#: 278

EMC 3169 Rehan Sarwar Vol#: 278

EMC 3170 Lee Hudson Vol#: 278

EMC 3171 Stuart Kenter Vol#: 278

EMC 3172 Teetle Clawson Vol#: 278

EMC 3173 Suzy Hennigh Vol#: 278

EMC 3174 Heather L Garvock Vol#: 278

EMC 3175 Maryvonne Kutsch Vol#: 278

EMC 3176 Craig Collins Vol#: 278

EMC 3177 Vera DePass Vol#: 278

EMC 3178 Amber Lopez Vol#: 278

EMC 3179 Rachel Reilly Vol#: 278

EMC 3180 Karah Stokes Vol#: 278

EMC 3181 Thomas B Ross Vol#: 278

EMC 3182 Jennifer Bardeen Vol#: 278

EMC 3183 Kraig Grady Vol#: 278

EMC 3184 Mary Kuck Vol#: 278

EMC 3185 Earl Brightup Vol#: 278

EMC 3186 Dan Chercover Vol#: 278

EMC 3187 Penny Greenwich Vol#: 278

EMC 3188 Todd Hauser Vol#: 278

EMC 3189 Rebecca Ponder Vol#: 278

EMC 3190 Alison Acerra Vol#: 278

EMC 3191 Heidi Crawford Vol#: 278

EMC 3192 Sharon Dexter Vol#: 278

EMC 3193 Cheryle Costa Vol#: 278

EMC 3194 James Bohland Vol#: 278

EMC 3195 Joyce Hughes Vol#: 278

EMC 3196 Tonalty Ramirez Vol#: 278

EMC 3197 Sara Blackwell Vol#: 278

EMC 3198 Kathy VerDorn Vol#: 278

EMC 3199 Kathryn Goodwin Vol#: 278

EMC 3200 Marianne Franks Vol#: 278

EMC 3201 Jimmie jackson Vol#: 278

EMC 3202 Militza Lorenzo Vol#: 278

EMC 3203 Christy Milburn Vol#: 278

EMC 3204 Keike Meya Vol#: 278

EMC 3205 Teresa Robeson Vol#: 278

EMC 3206 Bradley Duke Vol#: 278

EMC 3207 Andrew Lindsey Vol#: 278

EMC 3208 Charles Lenhardt Vol#: 278

EMC 3209 Cindy Butler-Smith Vol#: 278

EMC 3210 Sarah Barnes Vol#: 278

EMC 3211 Barbara Hoffstetter Vol#: 278

EMC 3212 James Montgonery Vol#: 278

EMC 3213 Peggy Koller Vol#: 278

EMC 3214 Karan Enyedy Vol#: 278

EMC 3215 Diane Chandler Vol#: 278

EMC 3216 Ann Harkness Vol#: 278

EMC 3217 Brian Rabkin Vol#: 278