DOCKETS ENTERED on 04/04/01

Docket Title

Number

Documents received by the Dockets Management Branch "MAY" be posted on the internet. PLEASE DO NOT INCLUDE personal identifying information, i.e. date of birth, social security number, etc., in your correspondence.

THE DOCUMENTS IN THE FOLLOWING DOCKETS WILL BE LINKED AS SOON AS POSSIBLE. CLICK ON THE (*) TO SEE THE CONTENTS OF THE LISTED DOCKET. SOME DOCKETS, NOT LINKED TO THIS TABLE OF CONTENTS, WILL BE LINKED ELSEWHERE ON THE DOCKETS PAGE

76N-052N OTC Nasal Decongestants *

97D-0448 Test Procedures & Acceptance Criteria for New Drug Subs. *

99F-2673 Irradiation in the Production, Processing & Handling of Food *

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *

99P-1340 Declared Eternity eau de Parfum Misbranded *

00D-1598 Voluntary Labeling for Bioengineered Foods *

00N-1269 Labeling for human prescription drug/Biologic Products *

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

01N-0078 Assessment of Physician & Patient Attitudes Toward Direct-to *

01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC *

76N-052N OTC Nasal Decongestants

EMC 110 Michael Finley Vol#: 76

EMC 111 Walter Charen MD Vol#: 76

EMC 112 John Rhuark Vol#: 76

EMC 113 Merle Dargus Vol#: 76

EMC 114 Gretchen K G Underwood Vol#: 76

97D-0448 Test Procedures & Acceptance Criteria for New Drug Subs.

C 13 Bristol-Myers Squibb Vol#: 1

99F-2673 Irradiation in the Production, Processing & Handling of Food

EMC 72 Public Citizen Vol#: 4

EMC 73 Patrick Brodigan Vol#: 4

99N-1852 Status reports/postmarketing studies-human drugs&biological

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

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

C 17245 Linda F Butler Vol#: 495

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 2983 Len Davis Vol#: 206

C 2984 Laura Stansbury Vol#: 206

C 2985 Margaret Solomon Vol#: 206

C 2986 Bernice D Kennedy Vol#: 206

C 2987 Douglas M Fambrough PhD Vol#: 206

C 2988 Patricia Lievow Vol#: 206

C 2989 Bea Gibson Vol#: 206

C 2990 Patricia Cheruoff Vol#: 206

C 2991 Eleanor L Lieberman Vol#: 206

C 2992 Skyview Laboratory Inc Vol#: 206

C 2993 Michael A Mulligan Vol#: 206

C 2994 Keith Kaback MD Vol#: 206

C 2995 Cathie L Lamm Vol#: 206

C 2996 Ayesha N Charmuga Vol#: 206

C 2997 Mr & Mrs David Kempston Vol#: 206

C 2998 Karin Riley Thron Vol#: 206

C 2999 Elizabeth Wien Vol#: 206

C 3000 GLEC Vol#: 206

C 3001 Dave Porcello & 3 signatures Vol#: 206

C 3002 Jay Doubleday Vol#: 206

C 3003 Christine Earley Vol#: 206

C 3004 Ashley Baltich & Nicole Pucely Vol#: 206

C 3005 Stephen & Barrie Collins Vol#: 206

C 3006 Mary Taylor & 7 signatures Vol#: 206

C 3007 Joseph R Goldstone Vol#: 206

C 3008 Vella Bass Vol#: 206

C 3009 Gail Gilbert Vol#: 206

C 3010 Jeremy Collie Vol#: 206

C 3011 Carol A Smith Vol#: 206

C 3012 Shawn Newell Vol#: 206

C 3013 Kurt C Wilner Vol#: 206

C 3014 Julie A Malan Vol#: 206

EMC 645 Jill M Heins Vol#: 206

EMC 646 Bill & Marilyn Voorhies Vol#: 206

EMC 647 Tamara Smith Vol#: 206

EMC 648 Douglas Seif Vol#: 206

EMC 649 NUMBER NOT USED Vol#: 206

EMC 650 Margery Meisels Vol#: 206

EMC 651 Karen Clyde Vol#: 206

EMC 652 NUMBER NOT USED Vol#: 206

EMC 653 Kisa Mainardi Vol#: 206

EMC 654 Dana Buchwald Vol#: 206

EMC 655 Ruthie Sakheim Vol#: 206

EMC 656 David Masucci Vol#: 206

EMC 657 Edwina Scinta Vol#: 206

EMC 658 Jose Viera Vol#: 206

EMC 659 Jason Chapman Vol#: 206

EMC 660 Elliot L Gang Vol#: 206

EMC 661 Ellen Feighny Vol#: 206

EMC 662 R Reichert Vol#: 206

EMC 663 Kathryn Kawazoe Vol#: 206

EMC 664 Judy Reed Vol#: 206

EMC 665 Elly Benson Vol#: 206

EMC 666 Emanuel Goldman PhD Vol#: 206

EMC 667 David Richter Vol#: 206

EMC 668 Nancy Purdon Vol#: 206

EMC 669 Jane Langenes Vol#: 206

EMC 670 Joshua Ezekiel Vol#: 206

EMC 671 Camas Palmer Luethe Vol#: 206

EMC 672 Karen Anderson Vol#: 206

EMC 673 Sheryl Taucer Vol#: 206

EMC 674 Virginia Jonas Vol#: 206

EMC 675 Susan Levinson Vol#: 206

EMC 676 Ravi Grover Vol#: 206

EMC 677 Christiane Arnouts Vol#: 206

EMC 678 Craig Steele Vol#: 206

EMC 679 MiraBai Fairlight Vol#: 206

EMC 680 Jane Niles Vol#: 206

EMC 681 Kathryn Brinner Vol#: 206

EMC 682 Nicki Parke Vol#: 206

EMC 683 Brigitte Packer Vol#: 206

EMC 684 Barbara Platt Vol#: 206

EMC 685 Thomas Jerde Vol#: 206

EMC 686 Rick Epting Vol#: 206

EMC 687 Mike Herbert Vol#: 206

EMC 688 Scott Samuels Vol#: 206

EMC 689 Marie Harkins Vol#: 206

EMC 690 Elizabeth Songer Vol#: 206

EMC 691 Alison Roxby Vol#: 206

EMC 692 Ann Schaetzel Vol#: 206

EMC 693 Nisha Basu Vol#: 206

EMC 694 Sarah Handelsman Vol#: 206

EMC 695 Marjorie Schwartz Vol#: 206

EMC 696 MariLea Keating Vol#: 206

EMC 697 Mitchell Freedman Vol#: 206

EMC 698 Paula Vick Vol#: 206

EMC 699 Candace Young Vol#: 206

EMC 700 Jennifer Moore Vol#: 206

EMC 701 Mary Ledward Vol#: 206

EMC 702 Karen Benoit Vol#: 206

EMC 703 Suzanna Elkin Vol#: 206

EMC 704 Ian Himell Vol#: 206

EMC 705 Arlene Eckles Vol#: 206

EMC 706 Mary Lockwood Vol#: 206

EMC 707 Debra Bresnan Vol#: 206

EMC 708 Shari Conant Vol#: 206

EMC 709 Naaz Hosseini Vol#: 206

EMC 710 Deb Poole Vol#: 206

EMC 711 Liila Woods Vol#: 206

EMC 712 Krisitn Basta Vol#: 206

99P-1340 Declared Eternity eau de Parfum Misbranded

C 684 Margaret Burke Vol#: 17

EMC 241 April Coile Vol#: 17

EMC 242 Mary Lou Latini Vol#: 17

EMC 243 David Granum Vol#: 17

EMC 244 H. David & Tina M. Anderson Vol#: 17

EMC 245 Lynne Olivier Vol#: 17

EMC 246 Karen L. Bauer Vol#: 17

EMC 247 Carolyn Banks Vol#: 17

EMC 248 Susan Parker Leigh, M.Ed., C.C.N. Vol#: 17

EMC 249 Joni Branscome Vol#: 17

EMC 250 Barri Boone Vol#: 17

EMC 251 Karin Kelly-Givens Vol#: 17

EMC 252 Craig Barth Vol#: 17

EMC 253 Martha Zuckerman Vol#: 17

EMC 254 Sandra M. Manning Vol#: 17

EMC 255 Martha Zuckerman Vol#: 17

EMC 256 Maureen Horowitz Vol#: 17

EMC 257 Mike & Nancy Vlasaty Vol#: 17

EMC 258 Barbara L. Bechdol Vol#: 17

EMC 259 Linda Rendely Vol#: 17

EMC 260 Pamela Peterson Vol#: 17

EMC 261 Audrey Katz Vol#: 17

EMC 262 Martha Ochs-Efraimson Vol#: 17

EMC 263 Sandra Nixon Vol#: 17

EMC 264 Frances Litvin Vol#: 17

EMC 265 Eileen Kapler Vol#: 17

EMC 266 Wayne L. Miller Vol#: 17

EMC 267 Keith A. Wollen Vol#: 17

EMC 268 Elizabeth Waldron Vol#: 17

EMC 269 Sharon Sowers Vol#: 17

EMC 270 Willis S. Langford Vol#: 17

EMC 271 Edith Monroy Vol#: 17

EMC 272 Ritagale Elrod Vol#: 17

EMC 273 Jodi Ross Vol#: 17

EMC 274 Marj Schneider Vol#: 17

EMC 275 Amaele Liebermann Vol#: 17

EMC 276 Kathleen M. Babson Vol#: 17

EMC 277 Gary Duncan Vol#: 17

EMC 278 Miranda Smith Vol#: 17

EMC 279 Jessica Voigts Vol#: 17

EMC 280 Alice Connell Vol#: 17

00D-1598 Voluntary Labeling for Bioengineered Foods

C 861 Diane M. Ninn Vol#: 83

C 862 Michelle Bosomworth Vol#: 83

C 863 Antonio Blast Vol#: 83

C 864 Tammie Cramey Vol#: 83

C 865 Geri McGillicuddy Vol#: 83

C 866 Janet Pelletier Vol#: 83

C 867 Barry Svltanoff, MD Vol#: 83

C 868 Brenda Shawley Vol#: 83

00N-1269 Labeling for human prescription drug/Biologic Products

C 30 USP, U.S. Pharmacopeia Vol#: 3

C 31 Abbott Laboratories Vol#: 3

EC 6 concerned daughter and mother Vol#: 3

00N-1396 Bioengineered Foods Consumed By Humans or Animals

BKG 2 Background Material Vol#: 42

NEC 1 Vol#: 42

00N-1449 Changes to an Approved NDA or ANDA;Agency Information Collec

N 3 Vol#: 1

SS 1 Supporting Statement Vol#: 1

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

C 9398 Bernice McNEil Vol#: 724

C 9399 Robert & Judith Lockwood Vol#: 724

C 9400 Betty Hutchinson Vol#: 724

C 9401 Diane M Plante Vol#: 724

C 9402 Helen C Simon Vol#: 724

C 9403 Kathryn Harvath Vol#: 724

C 9404 Ann Tedrow Vol#: 724

C 9405 David Tulemen Vol#: 724

C 9406 Jacob Nacht Vol#: 724

C 9407 Maren Neweth Vol#: 724

C 9408 Emma Rose Duchesneau Vol#: 724

C 9409 Karen Dawn Vol#: 724

C 9410 Janet Buonaiuto Vol#: 724

C 9411 Court Skinner Vol#: 724

C 9412 Sheri Robinson Vol#: 724

C 9413 Charlotte Hee Vol#: 724

C 9414 Ron Milan Vol#: 724

C 9415 David Fox Vol#: 724

C 9416 Vene Snyder Vol#: 724

C 9417 Victor Skorapa, Jr Vol#: 724

C 9418 Henryka Roman Vol#: 724

C 9419 Eugeneall Franzblau Vol#: 724

C 9420 Kristel Ferry Vol#: 724

C 9421 Allen Strasburger Vol#: 724

C 9422 Jack W Liddle Vol#: 724

C 9423 Arun Kantharia Vol#: 724

C 9424 Robin Adair Vol#: 724

C 9425 Lee Harrison-Smith Vol#: 724

C 9426 Marti Darling Vol#: 724

C 9427 Catherine Locatis Vol#: 724

C 9428 R IKle Vol#: 724

C 9429 Linda S Bailly Vol#: 724

C 9430 Sharon Bakhareva Vol#: 724

C 9431 Mary Silva Vol#: 724

C 9432 Anita A Harris Vol#: 724

C 9433 Chris Forest Vol#: 724

C 9434 Gerald Rutt Vol#: 724

C 9435 Keith Kevan Vol#: 724

C 9436 Ken Shapiro Vol#: 724

C 9437 A A Philips Vol#: 724

C 9438 Isaac Dostis Vol#: 724

C 9439 Barbara P Gardner Vol#: 724

C 9440 E Edwards Vol#: 724

C 9441 Mr & Mrs Higgins Vol#: 724

C 9442 Helen G Garrison Vol#: 724

C 9443 Nancy Jones Vol#: 724

C 9444 Scott Taylor Vol#: 724

C 9445 Preston Rudy Vol#: 724

C 9446 Martha Fuchslin Vol#: 724

C 9447 Brian DeSuet Vol#: 724

C 9448 Jan Smith Vol#: 724

C 9449 Herbert B Zochry Vol#: 724

C 9450 Rachel H Girshido Vol#: 724

C 9451 Janet Nelson Vol#: 724

C 9452 Sheila Alberg Vol#: 724

C 9453 Kim Rochford Vol#: 724

C 9454 Dore Zamuff Vol#: 724

C 9455 Edward C Welch Vol#: 724

C 9456 Julie Ann Allender Vol#: 724

C 9457 Angelique Michael Vol#: 724

C 9458 Barbara & Stuart Kobrick Vol#: 724

C 9459 Felice Jambru Vol#: 724

C 9460 Roger Gates Vol#: 724

C 9461 Alison Eastlake Vol#: 724

C 9462 Sherrie Patterson Vol#: 724

C 9463 Peter Cohen Vol#: 724

C 9464 Larry Zellers Vol#: 724

C 9465 Roberta Sukenik Vol#: 724

C 9466 Leona A Gilmoar Vol#: 724

C 9467 Linda Brant Vol#: 724

C 9468 Jennifer C Conrad Vol#: 724

C 9469 V S Clay Vol#: 724

C 9470 Adelaid B Adams Vol#: 724

C 9471 Ben Bedwith Vol#: 724

C 9472 Betty Antolik Vol#: 724

C 9473 Ronald & Joyce MacInnis Vol#: 724

C 9474 Lorrie Montgomery Vol#: 724

C 9475 R R Kjellgren Vol#: 724

C 9476 Richard & Joyce Treu Vol#: 724

C 9477 Irene Lim Vol#: 724

C 9478 Mrs E J Valley Vol#: 724

C 9479 Lin Reilly Vol#: 724

C 9480 Ed & Nadine Smith Vol#: 724

C 9481 Susan Rogers Vol#: 724

C 9482 Janet C Tillotson Vol#: 724

C 9483 Stori Snyder Vol#: 724

C 9484 Louis Nuyens Vol#: 724

C 9485 Beth Perkins Vol#: 724

C 9486 Norval & John Bhendra-Fletcher Vol#: 724

C 9487 Sonia P Lopez Vol#: 724

C 9488 Audrey R McMahon Vol#: 724

C 9489 J McDonald Vol#: 724

C 9490 Carol Thomas Vol#: 724

C 9491 Kim Sherrill Vol#: 724

C 9492 kathleen Schigrloh Vol#: 724

C 9493 Thomas Bruder Vol#: 724

C 9494 Joy M Pack Vol#: 724

C 9495 Georgia D Harbin Vol#: 724

01D-0146 Deficient Submissions filed/Investigation of New Animal Drug

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

01N-0078 Assessment of Physician & Patient Attitudes Toward Direct-to

EC 2 Electrian Vol#: 1

EC 3 Mrs. Amy Larchuk Vol#: 1

EC 4 Ms. Josh Duyal Vol#: 1

EC 5 Mr. Peter reiner Vol#: 1

EC 6 Mr. richard shain Vol#: 1

01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC

C 28 Joan Bell Vol#: 3

C 29 Anne Miller Vol#: 3

C 30 Form letters count 97 Vol#: 4

C 31 7 signatures Vol#: 3

C 32 Barbara & Jim Brazear Vol#: 3

C 33 Vern Gilsdorf Vol#: 3

EMC 181 Carolleamy Vol#: 3

EMC 182 Terelyn Borel Vol#: 3

EMC 183 Mark J. McKnight Vol#: 3

EMC 184 Dinh Duy Vu Vol#: 3

EMC 185 Mark Cambiano Vol#: 3

EMC 186 Bing, David, Thomas & MeiLin Fields Vol#: 3

EMC 187 Georgia P. Dash Vol#: 3

EMC 188 David Cambiano Vol#: 3

EMC 189 Rich Fields Vol#: 3

EMC 190 Mrs. Elizabeth Himes Vol#: 3

EMC 191 Shirley & John Wolf Vol#: 3

EMC 192 Charles & Pamela Wilson Vol#: 3

EMC 193 Curtis Wolf Vol#: 3

EMC 194 L. M. Campanella Vol#: 3

EMC 195 Jacquie Markowski Vol#: 3

EMC 196 Richard Cowden Vol#: 3

EMC 197 Alex Arita Vol#: 3

EMC 198 Bruce Schirm Vol#: 3

EMC 199 Elsie Williams Vol#: 3

EMC 200 S. O'Malley Vol#: 3

01V-0163 Laser Light Show Q-beam Series Q-40(RG)(MC),Q-100G,Q-150G,

ACK 1 HFA-305 Vol#: 1

VAR 1 Pro Sound & Stage Lighting Vol#: 1

01V-0164 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Duck Inn Vol#: 1

01V-0165

ACK 1 HFA-305 Vol#: 1

VAR 1 Greg McNeelly Vol#: 1

01V-0166

ACK 1 HFA-305 Vol#: 1

VAR 1 Sound Connection Vol#: 1