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 3, 2000

TABLE OF CONTENTS

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95S-0316 75-Day Premarket Notifications for New Dietary Ingredients *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
00D-1384 Physical Examination of Surgeons' &/or Patient Exam Gloves *
00D-1455 Premarket Notification for Totally Implanted Spinal Cord *
00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal *
00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair *
00N-1399 Presubmission Conferences *
00N-1571 Enrofloxacin for Poultry: Opportunity for hearing *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1600 ANADA Suitability for Ivermectin *

95S-0316 75-Day Premarket Notifications for New Dietary Ingredients

RPT 79 Pharmaco Behavioral Associates Inc Vol#: 41

98D-0272 FDAMA Section 127 Pharmacy Compounding

ANS 1 HFD-5 Vol#: 1

C 13 International Academy of Compounding Pha Vol#: 1

C 14 Purged Vol#: 1

EXT 1 International Academy of Compounding Pha Vol#: 1

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

C 2441 Scott Culler & Carrie Hancroln Vol#: 74

C 2442 Elizabeth Ungar Vol#: 74

C 2443 A. Quinn Vol#: 74

C 2444 Lori Dority Vol#: 74

C 2445 Tammy R. McCullough Vol#: 74

C 2446 Barbara Bonsignore Vol#: 74

C 2447 Barbara Branker Vol#: 74

C 2448 Jerri Lyn Miller Vol#: 74

C 2449 Keith & Nancy Ruddick Vol#: 74

C 2450 Judy Cowger Vol#: 74

C 2451 Bob J. Nistler Vol#: 74

C 2452 Shirley & William Kovar Vol#: 74

C 2453 Veronica Sanders Vol#: 74

C 2454 D. Hackett Vol#: 74

C 2455 Elizabeth McElligott Vol#: 74

C 2456 Betty Harla Vol#: 74

C 2457 Florence L. Orth Vol#: 74

C 2458 Sheila A. Bagner Vol#: 74

C 2459 Elvira Capiaghi Vol#: 74

C 2460 Geri Erb Vol#: 74

C 2461 Ms Lydia Garvey Vol#: 74

C 2462 Diane Riel Vol#: 74

C 2463 Christine M. Cuglielms Vol#: 74

C 2464 Sue M. Watkins Vol#: 74

C 2465 Donna Ruper Vol#: 74

C 2466 Cynthia Embree-Lavoic Vol#: 74

C 2467 Evelyn Hartem Vol#: 74

C 2468 Barbara L. Basso Vol#: 74

C 2469 Norman Burstein Vol#: 74

C 2470 Berniece Helms Vol#: 74

C 2471 H. Abraham Topper Vol#: 74

C 2472 Form letter count 5 Vol#: 75

EMC 151 Andrea Baer Vol#: 74

EMC 152 Kenn Agata Vol#: 74

EMC 153 Tatjana Morgan Vol#: 74

EMC 154 Robin Betian Vol#: 74

EMC 155 Sondra Cannon Vol#: 74

EMC 156 Melissa A. Alford Vol#: 74

EMC 157 Carol Price Vol#: 74

EMC 158 Melanie Fredericks Vol#: 74

EMC 159 Tracey Nixon Vol#: 74

EMC 160 Vicki Douglas Vol#: 74

EMC 161 Bryan & Mary Spey Vol#: 74

EMC 162 Myla Smith Vol#: 74

EMC 163 Sr. Marci Blum Vol#: 74

EMC 164 Teresa A. Doyle Vol#: 74

EMC 165 Mark M. Giese Vol#: 74

EMC 166 Timothy D. Wampler Vol#: 74

EMC 167 Michelle Barrett Vol#: 74

EMC 168 Carol S. Green Vol#: 74

EMC 169 Tracy Jordan Vol#: 74

EMC 170 Lauren Murphy Vol#: 74

EMC 171 Steve Douglas Vol#: 74

EMC 172 Jason & Shawna Vol#: 74

EMC 173 Form letter count 16 Vol#: 76

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

C 15765 Lee Ann Jacobson-Lindsey Vol#: 464

C 15766 Irene H. Dunham Vol#: 464

C 15767 Tulita E. Rudy Vol#: 464

C 15768 Carol & Brisk Young Vol#: 464

C 15769 Jean Lopardo Vol#: 464

C 15770 Mary P. Mathis Vol#: 464

C 15771 Eric E. Ballard Vol#: 464

C 15772 L. Sollisch Vol#: 464

C 15773 Bernice Rittner Vol#: 464

C 15774 Phyllis Mullett Vol#: 464

C 15775 Richard M. Petty Vol#: 464

C 15776 Judy I. Miller Vol#: 464

C 15777 William Voss Vol#: 464

C 15778 Denise Anne Canon Vol#: 464

C 15779 Patricia Pondergrass Vol#: 464

C 15780 Mrs. Robin E. Bruegeman Vol#: 464

C 15781 Mr & Mrs William E. Reed Vol#: 464

C 15782 Julie Richmond Vol#: 464

C 15783 Leah P. Roberts Vol#: 464

C 15784 Lillian M. Sutkevich Vol#: 464

C 15785 Q. Craig Vol#: 464

C 15786 Beth Redman Vol#: 464

C 15787 Mary Travis Vol#: 464

C 15788 William Cassidy Vol#: 464

C 15789 E. Alyne Meltzer Vol#: 464

C 15790 Jennifer Irene Pope Vol#: 464

C 15791 Donna Headen Vol#: 464

C 15792 Rachel Delono Vol#: 464

C 15793 Alan Huessy Vol#: 464

C 15794 R. F. McCormick Vol#: 464

C 15795 Henry Redkey Vol#: 464

C 15796 Bernard M. Bleeker Vol#: 464

C 15797 Dorothy J. Johnson Vol#: 464

C 15798 Sheryl Wachter Vol#: 464

C 15799 M. Laurie Collier Vol#: 464

C 15800 Jerry E. Marks Vol#: 464

C 15801 Brenda Hughes Vol#: 464

C 15802 M. E. W. McConnell Vol#: 464

C 15803 James T. Todd Vol#: 464

C 15804 Inger Burns Vol#: 464

C 15805 Aaron T. Morrison Vol#: 464

C 15806 Joseph M. Merritt Vol#: 464

C 15807 Diane Mentzer Vol#: 464

C 15808 Krystal Biglane Vol#: 464

C 15809 Christine Easterday Vol#: 464

C 15810 Mrs. Dirikinzie Vol#: 464

C 15811 Deborah Haynes Vol#: 464

C 15812 Jean M. Plain Vol#: 464

C 15813 James Jensen Vol#: 464

C 15814 Gloria Marshall Vol#: 464

C 15815 Margery L. Reed Vol#: 464

C 15816 Rosella E. Tisl Vol#: 464

C 15817 Robert Ranellone Vol#: 464

C 15818 Elaine Granata Vol#: 464

C 15819 Helen Kline Vol#: 464

C 15820 Jacqueline Bolduc Vol#: 464

C 15821 Roberta S. Dauer Vol#: 464

C 15822 Patricia L. Lefko Vol#: 464

C 15823 Michael & Leslie Mahoney Vol#: 464

C 15824 Sharon Balin Vol#: 464

C 15825 April Morgan Vol#: 464

C 15826 Laura J. France Vol#: 464

C 15827 Mr & Mrs W. E. Cribbs Vol#: 464

C 15828 Thelma Hawkes Vol#: 464

C 15829 Daniel & Darlene Hageberg Vol#: 464

EMC 3207 Kathy Van Dame Vol#: 464

EMC 3208 Laura White Vol#: 464

EMC 3209 Arius Hopman Vol#: 464

EMC 3210 Jim Tapp Vol#: 464

EMC 3211 Dr. Dorothy K. Cinquemani Vol#: 464

EMC 3212 Lisa DeVaney Vol#: 464

EMC 3213 Arch McCulloch Vol#: 464

EMC 3214 Donna Hoaglin Vol#: 464

EMC 3215 Johnathan L. Logan Vol#: 464

EMC 3216 Chris Fischetti Vol#: 464

EMC 3217 Sue Kropp Vol#: 464

EMC 3218 Judith Canepa Vol#: 464

EMC 3219 Eric Johnson Vol#: 464

EMC 3220 Patricia Rodgers Vol#: 464

EMC 3221 Dwain Anderson Vol#: 464

EMC 3222 Stuart Zisman Vol#: 464

EMC 3223 Tammie Lewis Vol#: 464

EMC 3224 Beverly Kudeki Vol#: 464

EMC 3225 Michael Morris Vol#: 464

EMC 3226 Candace Brandt Vol#: 464

EMC 3227 Jonas Ehudin Vol#: 464

EMC 3228 Candice Guth Vol#: 464

EMC 3229 Mary Anne Schiavone Vol#: 464

00D-1384 Physical Examination of Surgeons' &/or Patient Exam Gloves

C 8 Malaysian Rubber Glove Manufacturers Ass Vol#: 1

00D-1455 Premarket Notification for Totally Implanted Spinal Cord

C 21 Sam Maywood MD Vol#: 1

C 22 Center for Pain Management Vol#: 1

C 23 Medtronic Vol#: 1

00M-1597 PMA TECHNOLAS 217A Excimer Lawer System for Laser In-Situ

AAV 1 Bausch & Lomb Surgical Vol#: 1

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

ANS 1 HFW-014 to John B Breaux (CI) Vol#: 15

EMC 125 Helene Sorkin Vol#: 15

EMC 126 Alicia Anthony Vol#: 15

EMC 127 E Sandel Vol#: 15

EMC 128 Kristen Schuldt Vol#: 15

00N-1364 Prescription Drug User Fee Act (PDUFA) Public Meeting

EMC 1 University of Baltimore School of Law Vol#: 3

EMC 2 RxHealthValue Vol#: 3

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

C 31 Stryker Biotech Vol#: 1

00N-1399 Presubmission Conferences

C 2 Novartis Animal Health US Inc Vol#: 1

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

C 1 Congress of the United States Vol#: 16

LET 1 HFV-1 to Bayer Corporation Vol#: 16

00P-0788 Totally Implanted Spinal Cord Stimulator

C 22 Center for Pain Management Vol#: 4

C 23 Sam Maywood MD Vol#: 4

C 24 ANS Vol#: 4

C 25 Medtronic Vol#: 5

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

C 7253 Karen Abraham Vol#: 320

C 7254 Susan Mullin Vol#: 320

C 7255 Mike Wolfe Vol#: 320

C 7256 Aidan Sutherland Vol#: 320

C 7257 Marit Hervis Vol#: 320

C 7258 Michelle Salerno Vol#: 320

C 7259 Debbie Johnston Vol#: 320

C 7260 Aniho Gaal Vol#: 320

C 7261 Sharon Smith Vol#: 320

C 7262 Cynthia A Walker Vol#: 320

C 7263 Jen Bomig Vol#: 320

C 7264 Donna Gibson Vol#:

C 7265 Annette J Gunderson Vol#: 320

C 7266 Gregory J Mullen Vol#: 320

C 7267 Freida Mullen Vol#: 320

C 7268 Olivia Stryker Vol#: 320

C 7269 Alicia Rojas Vgalde Vol#: 320

C 7270 Jane Dixon Vol#: 320

C 7271 Kim M Knewlton Vol#: 320

C 7272 Katherine Darling Vol#: 320

C 7273 Jim Overton Vol#: 320

C 7274 Diane Hays Vol#: 320

C 7275 Gary Householter Vol#: 320

C 7276 Leo Cherne Vol#: 320

C 7277 Edward Brewer Vol#: 320

C 7278 Marie Dickinson Vol#: 320

C 7279 Jennifer Joseph Vol#: 320

C 7280 Frank Zinno Vol#: 320

C 7281 Robyn O'Flaherty Vol#: 320

C 7282 Marie A Dixon Vol#: 320

C 7283 Tom Byron Vol#: 320

C 7284 Jose Vicente Franco Vol#: 320

C 7285 Virginia Campbell Vol#: 320

C 7286 Laura J Dorbuck Vol#: 320

C 7287 Lonnie T Renteria Vol#: 320

C 7288 Karathanos Grenaway Vol#: 320

C 7289 Sharon Hashimoto Vol#: 320

C 7290 D J Norton Vol#: 320

C 7291 Jiri Kurz Vol#: 320

C 7292 Don & Abbe DeLong Vol#: 320

C 7293 Jamie & bobbie Aster Vol#: 320

C 7294 Cindy Wessler Vol#: 320

C 7295 Gary Moore Vol#: 320

C 7296 Patricia J Bauersfeld Vol#: 320

C 7297 Donna Worley Vol#: 320

C 7298 Lynn Connor Vol#: 320

C 7299 Mike Shilo Vol#: 320

C 7300 Behr William Jr Vol#: 320

C 7301 Kaia Cockran Vol#: 320

C 7302 David W Gilbert, II Vol#: 320

C 7303 George Cooper Vol#: 320

C 7304 Amy Jo Hoppins Vol#: 320

C 7305 Lisa Crosby & Paul Becker Vol#: 320

C 7306 Blonca Tuteme Vol#: 320

C 7307 Molly Brown Vol#: 320

C 7308 Lori Nickles Vol#: 320

C 7309 M Wells Vol#: 320

C 7310 Rich Kersten Vol#: 320

C 7311 Jean F Wood Vol#: 320

C 7312 Rhonda Hayon Vol#: 320

C 7313 Thomas M Brunner Vol#: 320

C 7314 William Bilodeau Vol#: 320

C 7315 Gleason John Vol#: 320

C 7316 Jos Vaughn Vol#: 320

C 7317 Elie & Kathy Youssee Vol#: 320

C 7318 Beau Kenneth Jr Vol#: 320

C 7319 B J Nelson Vol#: 320

C 7320 Jason Poll Vol#: 320

C 7321 Marjorie D Adams Vol#: 320

C 7322 Chelsea B Mornson Vol#: 320

C 7323 Tamara Egans Vol#: 320

C 7324 Joan Brown Vol#: 320

C 7325 Wil Dixon Vol#: 320

C 7326 Armen Karl Vol#: 320

C 7327 Joseph Tucker Vol#: 320

C 7328 Adele Wardle Vol#: 320

C 7329 Callie Irish Vol#: 320

C 7330 S Blake Vol#: 320

C 7331 Cozette Jones Vol#: 320

C 7332 Dave Garrioch Vol#: 320

C 7333 Yolanda Cannon Vol#: 320

C 7334 Ann Selby Vol#: 320

C 7335 Tracy L Kronles Vol#: 320

C 7336 Rachel Beck Vol#: 320

C 7337 Helen Tokou Vol#: 320

00P-1600 ANADA Suitability for Ivermectin

ACK 1 HFA-305 Vol#: 1

CP 1 SciReg, Inc. Vol#: 1