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 29, 2000

TABLE OF CONTENTS

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96N-0393 MedWatch:FDA's Medical Prod Reporting Program Forms; Agency *
98D-0785 Medical imaging drugs and biologics *
98N-0359 Program priorities/Center for Food Safety & Applied Nutritin *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99D-4488 Reducing microbial food safety hazards for sprouted seeds *
99N-5556 Food Contact Substance Notification System *
99P-1340 Declared Eternity eau de Parfum Misbranded *
00D-1392 Guidance for Industry on Botanical Drug Products *
00D-1455 Premarket Notification for Totally Implanted Spinal Cord *
00N-0930 Nominations for Working Groups: Pharmaceutical Science AC *
00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair *
00P-0788 Totally Implanted Spinal Cord Stimulator *
00P-1548 Neoral Soft Gelatin Capsules *
00V-1546 Laser Light Show *
00V-1547 John Coodey Laser Light Show *
92N-0489 Taxol; Enviromental Assessments and Fonsi

EA 1 Paclitaxel Injection ANDA 75-184 Vol#:

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

C 27 Abbott Labs Vol#: 1

98D-0785 Medical imaging drugs and biologics

C 21 Nycomed Amersham Imaging Vol#: 2

98N-0359 Program priorities/Center for Food Safety & Applied Nutritin

C 58 Eridania Beghin Say-America Vol#: 6

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

EMC 3 Sue Lindgard Vol#: 67

99D-4488 Reducing microbial food safety hazards for sprouted seeds

EMC 7 PPMOCK Vol#: 8
 
 

99D-4489 Sampling & microbial testing of spent irrigation water

EMC 7 PPMOCK Vol#: 6
 
 

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

C 15211 Birdy Szany Vol#: 454

C 15212 Joseph Duignan Vol#: 454

C 15213 Byron W. Jeffries, Jr. Vol#: 454

C 15214 Julienne VanDerziel Vol#: 454

C 15215 Victoria Wood Vol#: 454

C 15216 Mr & Mrs Ben DiLiberti Vol#: 454

C 15217 Doris J. Kukos Vol#: 454

C 15218 Kelly Eileen McLane Vol#: 454

C 15219 H. Schwer Vol#: 454

C 15220 William Stoothoff Vol#: 454

C 15221 Lisa DeVike Vol#: 454

C 15222 Nicole Harlan-Hiaq Vol#: 454

C 15223 Arianna Frakes Vol#: 454

C 15224 Elaine Sheparo Vol#: 454

C 15225 no signature Vol#: 454

C 15226 Shirley A. McBride Vol#: 454

C 15227 James T. Orgel, Sr. Vol#: 454

C 15228 Robyn Washburn Vol#: 454

C 15229 Alfreda Cornwell Vol#: 454

C 15230 Shirley H. Magder Vol#: 454

C 15231 Mildred Shurboff Vol#: 454

C 15232 Leland & Beatrice Foster Vol#: 454

C 15233 Joline Gibson Vol#: 454

C 15234 Luther E. Summers Vol#: 454

C 15235 Diana Bond Vol#: 454

C 15236 Kim Cauzza Vol#: 454

C 15237 Garry Emerson Vol#: 454

C 15238 Dorann Gray Vol#: 454

C 15239 Kathleen M. Zwar Vol#: 454

C 15240 Janine Veilleux Vol#: 454

C 15241 Sylvia Hines Honey Vol#: 454

C 15242 Josephine Stenback Vol#: 454

C 15243 Hazel Spandlin Vol#: 454

C 15244 Floyd & Marjorie Slaten Vol#: 454

C 15245 Mary C. Berrettini Vol#: 454

C 15246 L. M. Anderson Vol#: 454

C 15247 Patricia Mogg Vol#: 454

C 15248 Paul & Peggy Graham Vol#: 454

C 15249 Willie Roberson Vol#: 454

C 15250 Calista Jane Martin Vol#: 454

C 15251 Catherine Kjartanson Vol#: 454

C 15252 Michael Smith & Kristen Brennan Vol#: 454

C 15253 Daniel Fitgerald +10 signatures Vol#: 454

C 15254 Jim Yarbrough Vol#: 454

C 15255 Shirley J. Self Vol#: 454

C 15256 Dorothy C. Newton Vol#: 454

C 15257 Barbara Boudry Vol#: 454

C 15258 LeVerne Wieland Vol#: 454

C 15259 Beth Gudbrandson, Jeff & Peggy Hodgn Vol#: 454

C 15260 Dale B. Hornberger, Sr. Vol#: 454

C 15261 Gene Scholter Vol#: 454

C 15262 William Thomas Akerman Vol#: 454

C 15263 Margaret Bahny Vol#: 454

C 15264 Susan B. Coogan Vol#: 454

C 15265 Kelly Stuart Vol#: 454

C 15266 Bev Dittrich Vol#: 454

C 15267 Mr & Mrs Ronald L. Webb Vol#: 454

C 15268 Steve Shaffer Vol#: 454

C 15269 Grace Dovan Vol#: 454

C 15270 Richard & Kate Lee Vol#: 454

C 15271 Geneva Ellis Vol#: 454

C 15272 Robin Moran Vol#: 454

C 15273 Norma Jones Vol#: 454

C 15274 Heather Conley Vol#: 454

C 15275 Leigh C. Price Vol#: 454

C 15276 Maurine Gordon Vol#: 454

C 15277 Anna M. & Richard Drinner Vol#: 454

C 15278 Bonnie W. Young Vol#: 454

C 15279 Charlottte Pelton Vol#: 454

C 15280 Cleveland Labat Vol#: 454

C 15281 Beatrice I. Gray Vol#: 454

C 15282 Charlotte M. Richardson Vol#: 454

C 15283 H. Dean Caudle Vol#: 454

C 15284 Robert F. Mori Vol#: 454

C 15285 Keith F. Greenwood Vol#: 454

C 15286 Paul L. Mick, Jr. Vol#: 454

C 15287 Mark J. Sicherman, MD Vol#: 454

C 15288 Mrs. Vira M. Watson Vol#: 455

C 15289 Carol Clyde Vol#: 455

C 15290 Lois A. Rinck Vol#: 455

C 15291 Nathan J. Levine Vol#: 455

C 15292 Courtney Butler Vol#: 455

C 15293 Catherine Girard Vol#: 455

C 15294 Susan Laub Vol#: 455

C 15295 Elizabeth Brinegar Vol#: 455

C 15296 Barbara P. Gallagher Vol#: 455

C 15297 Charlotte Ann Jones Vol#: 455

C 15298 Nancy Priest Vol#: 455

C 15299 Charlotte D. Bonini Vol#: 455

C 15300 Betty J. Davis Vol#: 455

EMC 3126 Martin Bakker Vol#: 455

EMC 3127 Kenneth MacArthur Vol#: 455

EMC 3128 Carol Smith Vol#: 455

EMC 3129 Sean McNamara Vol#: 455

EMC 3130 Lee Halper & Family Vol#: 455

EMC 3131 Bari Lichtman Vol#: 455

EMC 3132 Bonnie Walden Vol#: 455

EMC 3133 Lauren Franklin Vol#: 455

EMC 3134 Biotechnology Industry Organization Vol#: 455

EMC 3135 Rebecca Harmon-Jones Vol#: 455

EMC 3136 Daniel Feldman Vol#: 455

EMC 3137 Roxanne Rothafel Vol#: 455

EMC 3138 David Shelton Vol#: 455

EMC 3139 Lillian Soldat Vol#: 455

EMC 3140 Joanne Collins Vol#: 455

EMC 3141 L. Tanzer Vol#: 455

EMC 3142 Patti Kraemer Vol#: 455

EMC 3143 Rebecca Rodgers Vol#: 455

99N-5556 Food Contact Substance Notification System

C 1 FPI, Foodservice & Packaging Institute,I Vol#: 1

C 2 Society of the Plastic Industry, Inc. Vol#: 1

C 3 American Plastics Council Vol#: 1

99P-1340 Declared Eternity eau de Parfum Misbranded

C 668 LaVonne Ellis Vol#: 16
 

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

C 466 Texas Department of Health Vol#: 23

C 467 Hank Luckower Vol#: 23

C 468 Steve Cockram Vol#: 23

C 469 Produce Marketing Assn Vol#: 23

C 470 Lavata R Jones Vol#: 23

C 471 Charles F Cooner Vol#: 23

C 472 Georgetown University Vol#: 23

C 473 Grocery Mfrs of American (CMA) Vol#: 23

C 474 David Zeff Vol#: 23

C 475 Julie Staub Vol#: 23

C 476 Richard Ketover Vol#: 23

C 477 Assunta A Wigandt Vol#: 23

C 478 Herbert F Schwarz Vol#: 23

C 479 USDA's Children's Nutrititon Research Ct Vol#: 23

C 480 U of Michigan School of Public Health Vol#: 23

C 481 Florette R Shrago Vol#: 23

C 482 Steven J Minucci Vol#: 23

C 483 Rick Talakowski Vol#: 23

C 484 Jerry Truettner Vol#: 23

C 485 Lynn A Frattasio Vol#: 23

C 486 Christopher D Gardner PhD Vol#: 23

C 487 Ella M Turgasen Vol#: 23

C 488 Robert L Tinkler Vol#: 23

C 489 Elam Rutt Vol#: 23

C 490 Molly V MacGowan Vol#: 23

C 491 JoAnn E Manson Vol#: 23

C 492 Biscuit & Cracker Mfs Assn (B&CMA) Vol#: 23

C 493 Sylvia F Foley Vol#: 23

C 494 ASTCDPD Vol#: 23

C 495 Kraft Foods Vol#: 23

C 496 Mary O'Neal Vol#: 23

C 497 Sylvia Buchholz Vol#: 23

EMC 331 Elizabeth Marlin Vol#: 23

EMC 332 Dan Bessesen MD Vol#: 23

EMC 333 J W Suttie Vol#: 23

SUP 4 CSPI Vol#: 24

00D-1392 Guidance for Industry on Botanical Drug Products

C 2 Guangzhou Intl. Bioisland Development Co Vol#: 1

00D-1455 Premarket Notification for Totally Implanted Spinal Cord

EXT 1 Medtronic Neurological Vol#: 1

00N-0930 Nominations for Working Groups: Pharmaceutical Science AC

LET 1 DHHS/FDA Vol#: 1

LET 2 DHHS/FDA Vol#: 1

LET 3 University of New Mexico Hlth Sciences C Vol#: 1

LET 4 Dr. Stephen J. Newsholme Vol#: 1
 
 

00N-1200 Dietary Supplements Containing Ephedrine Alkaloids

C 22 NNFA, National Nutritional Foods Assn. Vol#: 65

NM 2 Public Meeting on the Safety of Dietary Vol#: 65

REF 3 Reference Vol#: 65
 

00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal

EMC 111 Form letter count 19 Vol#: 16

EMC 112 Form letter count 22 Vol#: 17

00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair

C 26 Richard J. Feldman, M.D. Vol#: 1

00P-0788 Totally Implanted Spinal Cord Stimulator

EXT 1 Metronic Vol#: 1

00P-1548 Neoral Soft Gelatin Capsules

ACK 1 HFA-305 Vol#: 1

CP 1 Lachman Consultant Services, Inc. Vol#: 1

00V-1546 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Linden Laser Systems Vol#: 1

00V-1547 John Coodey Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 John Coodey Vol#: 1