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 May 29, 2001

TABLE OF CONTENTS

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NOTE:  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.

[FDA DOCKETS PAGE] [FDA HOME PAGE]  [ ITEM CODES ]

 
00D-1598 Voluntary Labeling for Bioengineered Foods *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-0499 Review/Act on SKB '132 Form C & '423 Form A patent for NDA20 *
01P-0239 ANDA Suitability for Amlodipine "Caplet" *
01P-0240 ANDA Suitability for Ramipril "Caplet" *
01P-0241 ANDA Suitability for Paroxetine "Caplet" *
01P-0242 ANDA Suitability for Simvastin "Caplet" *
01P-0243 ANDA Suitability for Fluoxetine "Caplet" *
01P-0248 Clarify Issues Relating to Patent Listings in "Orange Book" *

96P-0460 Add Clotrimazole 1.0% for Treatment of Athlete's Foot etc.

NPR 1 Vol#: 1

96P-0484 Rotating Membrane Filtration Blood Cell Separation Systems

N 1 Vol#: 3

00D-0084 Special Protocol Assessment

N 1 Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

C 2928 Mirium Gaines Vol#: 265

C 2929 Rachel Hein Vol#: 265

C 2930 Amy Best Vol#: 265

C 2931 Jacqueline Lerche Vol#: 265

C 2932 Jean Gardner Vol#: 265

C 2933 Lelarae Murray Vol#: 265

C 2934 Melissa L. Bridges Vol#: 265

C 2935 Julie Stentz Vol#: 265

C 2936 B. Ivez Vol#: 265

C 2937 G. Braunstein Vol#: 265

C 2938 Christian Rivera Vol#: 265

C 2939 Ann Sarmento Vol#: 265

C 2940 Bojan Trgovcevic Vol#: 265

C 2941 S. Vasael Vol#: 265

C 2942 Cynthia Berger Vol#: 265

C 2943 Diane Gentilini Vol#: 265

C 2944 Bill Williams Vol#: 265

C 2945 Kari Foley Vol#: 265

C 2946 Dolores Wyrobek Vol#: 265

C 2947 Jean Casono Vol#: 265

C 2948 Cori Walter Vol#: 265

C 2949 Robert Young Vol#: 265

C 2950 Michael Howard Vol#: 265

C 2951 Barbara Rodriquez Vol#: 265

C 2952 Margaret Rose Jaros Vol#: 265

C 2953 J. Irvine/L. Madore Vol#: 265

C 2954 Enos Hershberger Vol#: 265

C 2955 Food Marketing Institute Vol#: 265

C 2956 Dik Cool Vol#: 265

C 2957 J. Capozzelli Vol#: 265

C 2958 Mike Huber Vol#: 265

C 2959 Paul Rochford Vol#: 265

C 2960 R. Johnson Vol#: 265

C 2961 Diana L. Hallinen, MD Vol#: 265

C 2962 Marilyn Couture Vol#: 265

C 2963 Judy Tomer Vol#: 265

C 2964 Suzanne Camino Vol#: 265

C 2965 James E. Hoyt Vol#: 265

C 2966 Bella Sherman Vol#: 265

C 2967 S. Arnold Vol#: 265

C 2968 Jacqueline Courteau Vol#: 265

C 2969 Tracey Easthope Vol#: 265

C 2970 Ann L. Lund Vol#: 265

C 2971 Colleen Redman Vol#: 265

C 2972 Jill K. Quich Vol#: 265

C 2973 J. Davis Vol#: 265

C 2974 Julia W. Rizzo Vol#: 265

C 2975 Louise Le Cam Vol#: 265

C 2976 Valerie Peebles Vol#: 265

C 2977 Elizabeth Plumb Vol#: 265

C 2978 A. Miller Vol#: 265

C 2979 Sonya Mucller Vol#: 265

C 2980 Virginia Rudloff Vol#: 265

C 2981 Alissa Kiesling Vol#: 265

C 2982 Tony Altobellis Vol#: 265

C 2983 Janna Pijoan Vol#: 265

C 2984 American Seed Trade Association Vol#: 265

C 2985 CSPI Vol#: 265

C 2986 American Crop Protection Association Vol#: 265

C 2987 National Association of Wheat Growers Vol#: 265

C 2988 American Seed Trade Association, Inc. Vol#: 265

C 2989 Ms. Jolene D. Riley Vol#: 265

C 2990 Jay Clifton Vol#: 265

C 2991 J. Erik Weibel, M.D. Vol#: 265

C 2992 Karen Taussig-Lux Vol#: 265

C 2993 Joseph Spinozzi Vol#: 265

C 2994 Association of Food and Drug Officials Vol#: 265

C 2995 United Soybean Board Vol#: 265

C 2996 Roger A. Hasse Vol#: 265

C 2997 Eligible Vol#: 265

C 2998 Mr & Mrs N. Amoruso Vol#: 265

C 2999 Judith Rudolph Vol#: 265

C 3000 Judith Rudolph Vol#: 265

C 3001 Mary E. McGilligan Vol#: 265

C 3002 Ramona Guideud Vol#: 265

C 3003 Scott G. Walker Vol#: 265

C 3004 Mikaila Milton Vol#: 265

C 3005 Pauline Normand Vol#: 265

C 3006 Tamara Withers Vol#: 265

C 3007 Daniel Pereura Vol#: 265

C 3008 Cecil Bothwell Vol#: 265

C 3009 Anna M. James Vol#: 265

C 3010 Jennifer Miller Vol#: 265

C 3011 Center for Food Safety Vol#: 265

C 3012 Jennifer N. Pike Vol#: 265

C 3013 Lucuma Designs Vol#: 265

C 3014 N. Sherr Vol#: 265

C 3015 M. Schreck Vol#: 265

C 3016 Chip Shepard Vol#: 265

C 3017 Beverly Ryder Vol#: 265

C 3018 Haley Tumper Olson Vol#: 265

C 3019 Karla Kirkman Vol#: 265

C 3020 Kirstein Mowrey Vol#: 265

C 3021 Norma Cross Vol#: 265

C 3022 Ada Browne Vol#: 265

C 3023 Barbara Martz Vol#: 265

EMC 4517 Judith McCormack Vol#: 264

EMC 4518 unsigned Vol#: 264

EMC 4519 Michael Bluejay Vol#: 264

EMC 4520 Michele Fiala Murray Vol#: 264

EMC 4521 Mitchell Spute Vol#: 264

EMC 4522 Priscilla Lee Vol#: 264

EMC 4523 Rhonda Fields Vol#: 264

EMC 4524 Brenda Stowe Vol#: 264

EMC 4525 unsigned Vol#: 264

EMC 4526 Morgaine Leigh Vol#: 264

EMC 4527 Angie Collez Vol#: 264

EMC 4528 The Rev. Ronald G. Bell Vol#: 264

EMC 4529 Sara Dupont Vol#: 264

EMC 4530 Kate Geffken Vol#: 264

EMC 4531 Dee Walter Vol#: 264

EMC 4532 Pamela Ross Vol#: 264

EMC 4533 Carol Apodaca Vol#: 264

EMC 4534 Jylle Benson-Gauss Vol#: 264

EMC 4535 Sarah Balanoff Vol#: 264

EMC 4536 Jabe R. Hammond Vol#: 264

EMC 4537 Joy Sloan Vol#: 264

EMC 4538 Peggy Lutz Vol#: 264

EMC 4539 Vijaykumar Chalasani Vol#: 264

EMC 4540 Gale Gray Vol#: 264

EMC 4541 Judy Reed Vol#: 264

EMC 4542 unsigned Vol#: 264

EMC 4543 Richard Marra Vol#: 264

EMC 4544 Mary Wendt Vol#: 264

EMC 4545 Robert Scarr Vol#: 264

EMC 4546 Amenra Tahotep Vol#: 264

EMC 4547 Patty Gorton Vol#: 264

EMC 4548 Robyn Feinsod Vol#: 264

EMC 4549 Stacie Argetsinger Vol#: 264

EMC 4550 Nellie Arnold Vol#: 264

EMC 4551 Joan Bickford Vol#: 264

EMC 4552 Travis Jarrell Vol#: 264

EMC 4553 Z.C. Flores Vol#: 264

EMC 4554 Piper Voight Vol#: 264

EMC 4555 Norman Higginson Vol#:

EMC 4556 Jon Kendall Vol#: 264

EMC 4557 Don Kretschmann Vol#: 264

EMC 4558 Joanne VanDeusen Vol#: 264

EMC 4559 Jonathan Pi Vol#: 264

EMC 4560 Mona Lutz Vol#: 264

EMC 4561 Sarah Melvin Vol#: 264

EMC 4562 Amy Tranter Vol#: 264

EMC 4563 L. Valantine Vol#: 264

EMC 4564 Cinda Young Vol#: 264

EMC 4565 Terry Mooster Vol#: 264

EMC 4566 number not used Vol#: 264

EMC 4567 Mai Lowantel-Beare Vol#: 264

EMC 4568 Pamela Wickerd Vol#: 264

EMC 4569 Christine Johnson Vol#: 264

EMC 4570 Bexar County Green Party Vol#: 264

EMC 4571 unsigned Vol#: 264

EMC 4572 Irene Miller Vol#: 264

EMC 4573 Todd Vandermolen Vol#: 264

EMC 4574 Malcolm Lubliner Vol#: 264

EMC 4575 Nathan Morin Vol#: 264

EMC 4576 unsigned Vol#: 264

EMC 4577 Bottcher, Sandra Vol#: 264

EMC 4578 Kathleen Geffken Vol#: 264

EMC 4579 Angela Paschall Vol#: 264

EMC 4580 Sharon Parker Vol#: 264

EMC 4581 Sloan Anderson Vol#: 264

EMC 4582 Sam Johnston Vol#: 264

EMC 4583 Linda Richards Vol#: 264

EMC 4584 Beth Deene Vol#: 264

EMC 4585 Linda Richards Vol#: 264

EMC 4586 Zellene Sandler Vol#: 264

EMC 4587 Jill Davies & Rodd Gallaway Vol#: 264

EMC 4588 Bobby Hougham Vol#: 264

EMC 4589 Lori Moldovan Vol#: 264

EMC 4590 Thomas W. Lash Vol#: 264

EMC 4591 Patricia M. Williams Vol#: 264

EMC 4592 Jarmila Temelova Vol#: 264

EMC 4593 Crystal DiPietro Vol#: 264

EMC 4594 Philip H. Coe Vol#: 264

EMC 4595 Annette Welsh-Shinya Vol#: 264

EMC 4596 Shirley Strom Vol#: 264

EMC 4597 Mark Crimaudo Vol#: 264

EMC 4598 James Lewin Vol#: 264

EMC 4599 S P Vol#: 264

EMC 4600 Timothy Williams Vol#: 264

EMC 4601 Janet Campbell Vol#: 264

EMC 4602 Roger E. Bisland, Jr. Vol#: 264

EMC 4603 Julia Bagalay Vol#: 264

EMC 4604 Pat Pedersen Vol#: 264

EMC 4605 Maryanne Appel Vol#: 264

EMC 4606 Douglas Freidenstine Vol#: 264

EMC 4607 Wade Sikorski Vol#: 264

EMC 4608 Monte Eaton Vol#: 264

EMC 4609 Diana Hammer Vol#: 264

EMC 4610 Janine Yetke Vol#: 264

EMC 4611 Tim Woodall Vol#: 264

EMC 4612 Jan Stern Vol#: 264

EMC 4613 unsigned Vol#: 264

EMC 4614 Preston E. Wilson Vol#: 264

EMC 4615 Carina Tornow Vol#: 264

EMC 4616 Sara Millman Vol#: 264

EMC 4617 Candice Grace Vol#: 264

EMC 4618 Clayton Koenig Vol#: 264

EMC 4619 Bob Bland Vol#: 264

EMC 4620 Jill Robinson Vol#: 264

EMC 4621 Lori Soren Vol#: 264

EMC 4622 Johanna Maches Vol#: 264

EMC 4623 Jim Gerouard Vol#: 264

EMC 4624 Ruthanne Ferguson Vol#: 264

EMC 4625 Janet Steelman Vol#: 264

EMC 4626 Helen Livingston Vol#: 264

EMC 4627 Rene Remington Vol#: 264

EMC 4628 Rhonda Moorman Vol#: 264

EMC 4629 Vicki McCaffrey Vol#: 264

EMC 4630 Matthew Marturano Vol#: 264

EMC 4631 Deborah Bors Vol#: 264

EMC 4632 Charles Ashba Vol#: 264

EMC 4633 Karen Riden Vol#: 264

EMC 4634 Gwendoline Fortune Vol#: 264

EMC 4635 Kathleen Wacholtz Vol#: 264

EMC 4636 Heather Langan Vol#: 264

EMC 4637 Carol Bedient Vol#: 264

EMC 4638 Madeline Podnar Vol#: 264

EMC 4639 Mark Dahlstrom Vol#: 264

EMC 4640 Madeline Podnar Vol#: 264

EMC 4641 Karen Andersen Vol#: 264

EMC 4642 Norma Glad Vol#: 264

EMC 4643 Carol Steiner Vol#: 264

EMC 4644 Rhea Vol#: 264

EMC 4645 Elizabeth Berry Vol#: 264

EMC 4646 Patricia Smith Vol#: 264

EMC 4647 Thais Carr Vol#: 264

EMC 4648 Doniella Mattox Vol#: 264

EMC 4649 Cheryl Rasnick Vol#: 264

EMC 4650 Fabrizia Pratesi Vol#: 264

EMC 4651 Alberta Dettori Vol#: 264

EMC 4652 T. Simone Lipscomb Vol#: 264

EMC 4653 Lisa Wall Vol#: 264

EMC 4654 Cynthia Loving Vol#: 264

EMC 4655 Linda Rusecki Vol#: 264

EMC 4656 Raymond E. Patterson Vol#: 264

EMC 4657 Robert Parsons Vol#: 264

EMC 4658 Alex Casalboni Vol#: 264

EMC 4659 Alex Casalboni Vol#: 264

EMC 4660 David Barlow Vol#: 264

EMC 4661 Deborah Pincon Vol#: 264

EMC 4662 Linda E. Nedderman Vol#: 264

EMC 4663 Debra Martin Vol#: 264

EMC 4664 Terese Allen Vol#: 264

EMC 4665 Barbara McNally Vol#: 264

EMC 4666 Nancy Bennett Vol#: 264

EMC 4667 Gary Rosard Vol#: 264

EMC 4668 Denise Bundy Vol#: 264

EMC 4669 Zoe Gollogly Vol#: 264

EMC 4670 Janean Lesyk Vol#: 264

EMC 4671 Claudio Musajo Vol#: 264

EMC 4672 Jason B. Phelps Vol#: 264

EMC 4673 Rabbi Yosef Lange Vol#: 264

EMC 4674 Gabrielle Sappenfield Vol#: 264

EMC 4675 Shelley Hershey Vol#: 264

EMC 4676 Tara A. Proetta Vol#: 264

EMC 4677 ATom Riben Vol#: 264

EMC 4678 unsigned Vol#: 264

EMC 4679 unsigned Vol#: 264

EMC 4680 Basem Hassan Vol#: 264

EMC 4681 Sharon Abercrombie Vol#: 264

EMC 4682 Marla Pardee Vol#: 264

EMC 4683 Marla Pardee Vol#: 264

EMC 4684 Abby Williams Vol#: 264

EMC 4685 Megan Gregori Vol#: 264

EMC 4686 Megan Gregori Vol#: 264

EMC 4687 Catarina Prata Vol#: 264

EMC 4688 Paula Gavlen Vol#: 264

EMC 4689 Paula Gavlen Vol#: 264

EMC 4690 Abby Williams Vol#: 264

EMC 4691 Abby Williams Vol#: 264

EMC 4692 Katarina Popovic Vol#: 264

EMC 4693 Michelle Presley, Jason Presley Vol#: 264

EMC 4694 Michele Caws Vol#: 264

EMC 4695 Anita Taylor Vol#: 264

EMC 4696 Gail Camhi Vol#: 264

EMC 4697 unsigned Vol#: 264

EMC 4698 Connie Hansen Vol#: 264

EMC 4699 C. Ramsey Vol#: 264

EMC 4700 Michael Finney Vol#: 264

EMC 4701 Gail Camhi Vol#: 266

EMC 4702 Evan Porter Vol#: 266

EMC 4703 Evan Porter Vol#: 266

EMC 4704 Katharine Clark Vol#: 266

EMC 4705 Patrick Daugherty Vol#: 266

EMC 4706 Mathew Hanson Vol#: 266

00N-1219 Bacterial Vaccines & Related Biological Products

BKG 2 BACKGROUND MATERIAL Vol#: 1

N 2 Vol#: 1

00N-1396 Bioengineered Foods Consumed By Humans or Animals

EMC 5545 Philip Notermann Vol#: 189

EMC 5546 Pat Gayle Vol#: 189

EMC 5547 Sara Camp Vol#: 189

EMC 5548 Nancy Brown Vol#: 189

EMC 5549 Nancy Brown Vol#: 189

EMC 5550 Starr Klein Vol#: 189

EMC 5551 Colleen Novasielski Vol#: 189

EMC 5552 Lauren Darges Vol#: 189

EMC 5553 John Macey Vol#: 189

EMC 5554 Nathaniel Levin Vol#: 189

EMC 5555 Cynthia Pettit Vol#: 189

EMC 5556 Mary McLellan Vol#: 189

EMC 5557 Roy Padilla Vol#: 189

EMC 5558 Laura Culp Vol#: 189

EMC 5559 Jessica Harris Vol#: 189

EMC 5560 Brad Frank Vol#: 189

EMC 5561 Genevieve Vierling Vol#: 189

EMC 5562 Dorothy Hahn Vol#: 189

EMC 5563 Roy L. Pickett Vol#: 189

EMC 5564 Andrew Jolly Vol#: 189

EMC 5565 Tony Mayan Vol#: 189

EMC 5566 Nancy Omaha Boy Vol#: 189

EMC 5567 Beverly Gundlach Vol#: 189

EMC 5568 Andrea Sweeney Vol#: 189

EMC 5569 Scott P. Wilson Vol#: 189

EMC 5570 Megan Culler Vol#: 189

EMC 5571 Gail Odegaard Vol#: 189

EMC 5572 Stephanie Weaver Vol#: 189

EMC 5573 Daniella Chace Vol#: 189

EMC 5574 Gary Schoenberg Vol#: 189

EMC 5575 Bevrossi Vol#: 189

EMC 5576 Talitha Thalya Vol#: 189

EMC 5577 Dr. Mindy Rabia Barkins Vol#: 189

EMC 5578 Nadine Bauer Vol#: 189

EMC 5579 Susan Parker Leigh & James Leigh Vol#: 189

EMC 5580 Karla Christensen Vol#: 189

EMC 5581 Martha DeSisto Vol#: 189

EMC 5582 T. D. Harvey Vol#: 189

EMC 5583 Ed Fasanella Vol#: 189

EMC 5584 Elizabeth Kukely Vol#: 189

EMC 5585 Lindea Bowe Kirschner Vol#: 189

EMC 5586 Helen Moore Vol#: 189

EMC 5587 Tim Wargo MD Vol#: 189

EMC 5588 Greg Yaroslow Vol#: 189

EMC 5589 Jan Ballard Vol#: 189

EMC 5590 Deborah Grace Kraft Vol#: 189

EMC 5591 Rich Sims Vol#: 189

EMC 5592 Barry Snitkin Vol#: 189

EMC 5593 Charles Cranford Vol#: 189

EMC 5594 Lion Goodman Vol#: 189

EMC 5595 John Stayton Vol#: 189

EMC 5596 Sarah & Darren Volkay Vol#: 189

EMC 5597 Anne Dinshah & Curt Hamre Vol#: 189

EMC 5598 Laura Silber Vol#: 189

EMC 5599 Douglas & Margaret Bradley Vol#: 189

EMC 5600 John Kroonen Vol#: 189

EMC 5601 David Shapiro Vol#: 189

EMC 5602 Shirley Baker Vol#: 189

EMC 5603 Gregory Wieting Vol#: 189

EMC 5604 Wendy Richardson Vol#: 189

EMC 5605 Wendy Richardson Vol#: 189

EMC 5606 Lee Shinefield Vol#: 189

EMC 5607 Mary Kulakowski Vol#: 189

EMC 5608 Peter Stark Vol#: 189

EMC 5609 Gregory Babior Vol#: 189

EMC 5610 John Neville Vol#: 189

EMC 5611 Virginia Irvin Vol#: 189

EMC 5612 Panther Wilde Vol#: 189

EMC 5613 Michael Hathaway Vol#: 189

EMC 5614 Roy Eaton Vol#: 189

EMC 5615 Ginger Gray Vol#: 189

EMC 5616 Jonathan Ratner Vol#: 189

EMC 5617 Linda Hines Vol#: 189

EMC 5618 Jennifer Catania Vol#: 189

EMC 5619 Gary J. Proulx Vol#: 189

EMC 5620 Harney Vol#: 189

EMC 5621 Christine Aquillino Vol#: 189

EMC 5622 Bob Segal Vol#: 189

EMC 5623 Prof. John Delevoryas Vol#: 189

EMC 5624 Carole Currie Vol#: 189

EMC 5625 Carole Currie Vol#: 189

EMC 5626 Zita A. Lynn Vol#: 189

EMC 5627 Ruth E. Wells Vol#: 189

EMC 5628 Martha S. Cooley Vol#: 189

EMC 5629 Nancy Willbanks Vol#: 189

EMC 5630 Julia Weinmann Vol#: 189

EMC 5631 Lucia Rich Vol#: 189

EMC 5632 Janice Reinhart Vol#: 189

EMC 5633 number not used Vol#: 189

EMC 5634 Margaret Abernathy Vol#: 189

EMC 5635 Andrea Massey Vol#: 189

EMC 5636 Michael Colpo Vol#: 189

EMC 5637 Sesha Ward Vol#: 189

EMC 5638 Barbara Retson Vol#: 189

EMC 5639 Jonathan Lipman Vol#: 189

EMC 5640 Jennifer Barricklow Vol#: 189

EMC 5641 Walter Stokes Vol#: 189

EMC 5642 Carol Logan Vol#: 189

EMC 5643 Connie Ciekanski Vol#: 189

EMC 5644 Robert Kirschenbaum Vol#: 189

EMC 5645 Sue Goodell Vol#: 189

EMC 5646 James Servais Vol#: 189

EMC 5647 Judy Dragon Vol#: 189

EMC 5648 Gerald Martin Vol#: 189


00P-0499 Review/Act on SKB '132 Form C & '423 Form A patent for NDA20

C 5 Federal Trade Commission Vol#: 1

01H-0065 Civil Money Penalty for First Check Home Drug Test Decives

CS 3 HFA-305 Vol#: 1

OR 2 HF-3 Vol#: 1

01N-0205 Applications for FDA Approval to Market a New Drug

N 1 Vol#: 1

01N-0222 Medical Devices: Third-Party review under FDAMA;Agency Infor

N 1 Vol#: 1

01N-0231 Verterinary adverse drug reaction, lack of effect, product

N 1 Vol#: 1

01P-0239 ANDA Suitability for Amlodipine "Caplet"

ACK 1 HFA-305 Vol#: 1

CP 1 Cipher Pharmaceuticals Limited Vol#: 1

01P-0240 ANDA Suitability for Ramipril "Caplet"

ACK 1 HFA-305 Vol#: 1

CP 1 Cipher Pharmaceuticals Limited Vol#: 1

01P-0241 ANDA Suitability for Paroxetine "Caplet"

ACK 1 HFA-305 Vol#: 1

CP 1 Cipher Pharmaceuticals Limited Vol#: 1

01P-0242 ANDA Suitability for Simvastin "Caplet"

ACK 1 HFA-305 Vol#: 1

CP 1 Cipher Pharmaceutcials Limited Vol#: 1

01P-0243 ANDA Suitability for Fluoxetine "Caplet"

CP 1 Cipher Pharmaceuticals Limited Vol#: 1

01P-0248 Clarify Issues Relating to Patent Listings in "Orange Book"

ACK 1 HFA-305 Vol#: 1

CP 1 Federal Trade Commission Vol#: 1

Page updated September 17, 2003 jb