DOCKETS ENTERED on 04/05/01

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

77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products *

96P-0001 Disclosure of Results of Statistical Studies re: INDs *

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

00D-1393 Screening tests labeled for use w/ Cadaveric blood Specimens *

00D-1681 Potassium Iodide as a Thyroid Blocking Agent *

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

00N-1396 Bioengineered Foods Consumed By Humans or Animals *

00P-1210 Restrict Sale of Coal Tar-Containing Products *

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

01P-0122 To Remove False and Deceptive Labeling for Transderm Scop *

77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products

C 238 Bristol-Myers Squibb Co Vol#: 235

80N-0042 Anticaries Drug Products for OTC Human Use

AMD 3 Colgate-Palmolive Co Vol#: 37

96P-0001 Disclosure of Results of Statistical Studies re: INDs

LET 2 HFD-005 to D J Popeo & P D Kamenar Vol#: 1

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

C 4385 Farm Animal Defense Vol#: 138

C 4386 Summer Peters Vol#: 138

C 4387 Marilyn Furlano Vol#: 138

C 4388 Walter & Fran Hageman Vol#: 138

C 4389 Dayluar Zrlinshas Vol#: 138

C 4390 Ms. Lynda Weisman Vol#: 138

C 4391 Melanie Jackson Vol#: 138

C 4392 Brenda Frey Vol#: 138

C 4393 Margaret N Harrison Vol#: 138

C 4394 Rebekah Scogin Vol#: 138

C 4395 Ruth Brandt Vol#: 138

C 4396 Hirschkop & Associates, P.C. Vol#: 138

C 4397 Suzanne Martin Vol#: 138

C 4398 Mr. Bernard Caley Vol#: 138

C 4399 Norma Carol Vol#: 138

C 4400 Rita Morrison Vol#: 138

C 4401 John & Deborah Haynes Vol#: 138

C 4402 Ms. Betty Ottaway Vol#: 138

C 4403 D. Hachett Vol#: 138

C 4404 Tom Damsdell Vol#: 138

C 4405 Catherine D. Mizerany Vol#: 138

C 4406 Marc R. Freligh Vol#: 138

C 4407 Barbara Hayes Vol#: 138

C 4408 Jill Holland Vol#: 138

C 4409 Mrs. Joseph Saeva Vol#: 138

C 4410 Mr. & Mrs. P. Passalacqua Vol#: 138

C 4411 J. Capozzelli Vol#: 138

C 4412 Jessa Fisher Vol#: 138

C 4413 Marilyn A. Brown Vol#: 138

C 4414 Mrs. Eileen Adamec Vol#: 138

C 4415 Cecilla Sturla De Barata Vol#: 138

C 4416 S. K. Vol#: 138

EMC 1624 Sophia Nardin & Luke Wood Vol#: 138

EMC 1625 Keaven Van Lom Vol#: 138

EMC 1626 Cindy Kelly Vol#: 138

EMC 1627 Emily A. Beighley Vol#: 138

EMC 1628 Jessica Dadds Vol#: 138

EMC 1629 LaDonna Smith Vol#: 138

EMC 1630 George Ann Gregory, Ph.D. Vol#: 138

EMC 1631 Maria L. Therese Vol#: 138

EMC 1632 number not used Vol#: 138

EMC 1633 Jackie Muzio Vol#: 138

EMC 1634 Sandra Geyser & Howard Stoops Vol#: 138

EMC 1635 Karen Salzgeber Vol#: 138

EMC 1636 Donna M. Rasmussen Vol#: 138

EMC 1637 Gerard Burkhardt Vol#: 138

EMC 1638 Joe D'Angelo Vol#: 138

EMC 1639 Stephanie Thomas Vol#: 138

EMC 1640 Emily Fabiano Vol#: 138

99D-4130 Manufacturers to assemblers for Diagnostic X-Ray Systems

GDL 2 Final Guidance for Industry & FDA Vol#: 1

NAD 2 Vol#: 1

99F-2082 Safe Use of Food Starch Modified by Amyloytic Enzymes

NFR 1 Vol#: 1

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

C 17246 Shelly J Langshaw Vol#: 495

C 17247 Cynthia Moore Vol#: 495

C 17248 Jeffrey M Turner Vol#: 495

C 17249 Joseph R Embacher Vol#: 495

C 17250 Stephanie Shemo Vol#: 495

C 17251 Ruth De Paoli Vol#: 495

3

C 17252 Vernon E Owen Vol#: 495

C 17253 Frances Howe Vol#: 495

C 17254 John M Benjamin Vol#: 495

C 17255 Jane A Chellew Vol#: 495

C 17256 Genevieve Piraino Vol#: 495

C 17257 Barbara J Musselman Vol#: 495

C 17258 Floyd E Whitney Vol#: 495

C 17259 Charles E Flanegan Vol#: 495

C 17260 Aaron Weiss Vol#: 495

C 17261 Gordon Hasso Vol#: 495

C 17262 Thomas Sola Vol#: 495

C 17263 R I Smith Vol#: 495

C 17264 James Malone Vol#: 495

C 17265 Delonas B Snow Vol#: 495

C 17266 Glenn T Terry Vol#: 495

C 17267 Julia Hays Vol#: 495

C 17268 L Joy Schroeder Vol#: 495

C 17269 Thomas E Buggy Vol#: 495

C 17270 Janice Gienei Vol#: 495

C 17271 Carol Buffinton Vol#: 495

C 17272 Mr & Mrs Joseph Devine Vol#: 495

C 17273 Merlin & Donna Kliewer Vol#: 495

C 17274 Janeen Hand Vol#: 495

C 17275 Claudean Nicholson Vol#: 495

C 17276 Georgia Hoggatt Vol#: 495

C 17277 Machelle E Beck Vol#: 495

C 17278 Byron W Jeffries Vol#: 495

C 17279 Ellen Smucker Vol#: 495

C 17280 Dorothy Rachon Vol#: 495

C 17281 Annette Wilson Vol#: 495

C 17282 David Turner Vol#: 495

C 17283 Richard Balt Vol#: 495

C 17284 Emma A Woodward Vol#: 495

C 17285 Blaine M Hubbard Vol#: 495

C 17286 Karen Carlson Vol#: 495

C 17287 Gail Groening Vol#: 495

C 17288 Eva McGough Vol#: 495

C 17289 Edwin C Blood Vol#: 495

C 17290 Josephine S Ferguson Vol#: 495

C 17291 Walter R Giny Vol#: 495

C 17292 Sherry Clements Vol#: 495

C 17293 Antonia Wilcoxon Vol#: 495

C 17294 Daniel Furlong & Thomas Furlong Vol#: 495

C 17295 Sandra Weight Vol#: 495

C 17296 Kelly Fenstemaker Vol#: 495

C 17297 Nova Bolton Vol#: 495

C 17298 Myra Golubski Vol#: 495

C 17299 Richard G & Angelee Zadrapa Vol#: 495

00D-1033 Clinical Trials for Serious/Life-Threatening Diseases

NAL 1 Vol#: 1

SS 1 SUPPORTING STATEMENT Vol#: 1

00D-1393 Screening tests labeled for use w/ Cadaveric blood Specimens

C 4 Ctr for Organ Recovery& Education (CORE) Vol#: 1

C 5 Ctr for Organ Recovery& Education (CORE) Vol#: 1

00D-1681 Potassium Iodide as a Thyroid Blocking Agent

CR 1 Peter G Crane Vol#: 1

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

C 57 Eon Hyman Vol#: 18

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 324 Form Letter Count 18 Vol#: 43

C 325 Form Letter Count 107 Vol#: 44

C 326 Form Letter Count Vol#: 45

C 327 Form Letter Count 128 Vol#: 46

C 328 Form Letter Count 19 Vol#: 47

C 329 Form Letter Count 140 Vol#: 48

C 330 Form Letter Count 10 Vol#: 49

C 331 Form Letter Count 51 Vol#: 50

C 332 Form Letter Count 23 Vol#: 51

00P-1210 Restrict Sale of Coal Tar-Containing Products

ANS 1 HFD-105 Occupationial Knowledge Intern'l Vol#: 10

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

C 9496 Michael Rothgeb Vol#: 725

C 9497 Steven E Kiralla Vol#: 725

C 9498 Kristofer Young, DC Vol#: 725

C 9499 Agnes K Green, CN Vol#: 725

C 9500 Tracy Weatherby Vol#: 725

C 9501 Ilene Van Bruggen Vol#: 725

C 9502 John Kilburn Vol#: 725

C 9503 Kim Hiltner Vol#: 725

C 9504 Barbara Kolbi Vol#: 725

C 9505 Richard Amodio, PhD Vol#: 725

C 9506 Marione Leonard Vol#: 725

C 9507 Sandor Silverman Vol#: 725

C 9508 Bernice Bell Vol#: 725

C 9509 Dale Sekijima Vol#: 725

C 9510 M P Bronaugh Vol#: 725

C 9511 Stephen Bent Vol#: 725

C 9512 M Swanson Vol#: 725

C 9513 Brigit Johanson Vol#:

C 9514 Brenda L Howard Vol#: 725

C 9515 Joan E Schmitz Vol#: 725

C 9516 O J Lumphry Vol#: 725

C 9517 Deirdre Long Vol#: 725

C 9518 Heidi E Wakeman Vol#: 725

C 9519 Sandra Schneider Vol#: 725

C 9520 Vicky L Huber Vol#: 725

C 9521 Gerald Foley Vol#: 725

C 9522 Trish O Grady Vol#: 725

C 9523 Alice Hutchison Vol#: 725

C 9524 Frank Zwetsloot Vol#: 725

C 9525 Jill Vaken Vol#: 75

C 9526 Holli Hage Vol#: 725

C 9527 K N Miller Vol#: 725

C 9528 Betsy McIndoe Vol#: 725

C 9529 Dan Jones Vol#: 725

C 9530 John S Allerton Vol#: 725

C 9531 Kristi Larkin Vol#: 725

C 9532 Corey Mayer Vol#: 725

C 9533 Susan Schmidt Vol#: 725

C 9534 Meg Keoppen Vol#: 725

C 9535 Stefanie Graeter Vol#: 725

C 9536 Not clear Vol#: 725

8

DOCKETS ENTERED

on 04/05/01

 

Docket Title

Number

 

C 9537 Alice L Herron Vol#: 725

C 9538 David Harbin Vol#: 725

C 9539 Jennifer Hale Vol#: 725

C 9540 Tiffany Lang Vol#: 7

C 9541 Garold L Faber Vol#: 725

C 9542 Carolyn Crague Vol#: 725

C 9543 Richard Todd Williams Vol#: 725

C 9544 Robert Breodhy, PhD Vol#: 725

C 9545 Lorraine L Grace Vol#: 725

C 9546 Shirley Jenks Vol#: 725

C 9547 Renee-Marie Parry Vol#: 725

C 9548 David Mulvain, MS, LD Vol#: 725

C 9549 Sherrie Reed Vol#:

C 9550 Matt MEyers, M P H Vol#: 725

C 9551 Jo Anne Hall Vol#: 725

C 9552 Judy Luke Vol#: 725

C 9553 J C Luke Vol#: 725

C 9554 James S Cohen Vol#: 725

C 9555 Theola J Greene Vol#: 725

C 9556 Sandra Ehrenkranz Vol#: 725

C 9557 Philip Blank Vol#: 725

C 9558 Wendy J Brewer Vol#: 725

C 9559 Norman Condee Vol#: 725

C 9560 Dick Shaw Vol#: 725

C 9561 Cheryl Ray Vol#: 725

C 9562 Gary Rainville Vol#: 725

C 9563 C & E Toth Vol#: 725

C 9564 Janne Nielsen Vol#: 725

C 9565 Elizabeth Gynn Vol#: 725

C 9566 Ms Holly Leagh Vol#: 725

C 9567 Fran Ludwig Vol#: 725

C 9568 Eleanor F Bookwalle Vol#: 725

C 9569 J Kocheran Vol#: 725

C 9570 J H Shonyushi Vol#: 725

C 9571 Sandy Wavrick Vol#: 725

C 9572 Rob & Lynn Pizzeello Vol#: 725

C 9573 Elizabeth J Crosby Vol#: 725

C 9574 Joan M Pirrello Vol#: 725

C 9575 Michael Curek Vol#: 725

C 9576 William Strelow Vol#: 725

C 9577 Elizabeth Pearson Vol#: 725

C 9578 Dorothy Mauser Vol#: 725

C 9579 Pamela Stiles Vol#: 725

C 9580 W D Bentley Vol#: 725

C 9581 Mrs Judy W Soffler Vol#: 725

C 9582 W T Maseioli Vol#: 725

C 9583 Charles P Fisk Vol#: 725

C 9584 Lester L Smith Vol#: 725

C 9585 Dr Helene Knox Vol#: 725

C 9586 Deborah Homey Vol#: 725

C 9587 Ms Diana McCain Vol#: 725

C 9588 Cathy O Leary & John Carey Vol#: 725

C 9589 Ellen Kieval Vol#: 725

C 9590 Eileen M Voss Vol#: 725

C 9591 Norma G Daniel Vol#: 725

C 9592 Emele Clothieu Vol#: 725

C 9593 Patricia sharp Weiss Vol#: 725

C 9594 Michael Barclay Vol#: 725

C 9595 Moses Bernard, jr Vol#: 725

C 9596 John MacDougall & Marilyn MacDougall Vol#: 725

C 9597 Paul Berteau Vol#: 725

C 9598 Sally & Kenneth Cooper Vol#: 725

C 9599 Anne Irving Vol#: 725

C 9600 Charles Ginsberg Vol#: 725

C 9601 Julie Lynn Stump Vol#: 725

C 9602 Marcia Phillips Vol#: 725

C 9603 Sabina Krumpe, PhD Vol#: 725

C 9604 Robert J Richard Vol#: 725

C 9605 Henry Vildhuzin Vol#: 725

C 9606 Ms Kathaleen Ouellette Vol#: 725

C 9607 Fred Busher, MD Vol#: 725

C 9608 Wendy Whitehorn Vol#: 725

C 9609 Rachel Kaye Vol#: 725

C 9610 Joseph R Giles Vol#: 725

C 9611 Arthur I Ebbets Vol#: 725

C 9612 Sherry Streeter Vol#: 725

C 9613 L Joy Schroeder Vol#: 725

C 9614 Mary B Murray Vol#: 725

C 9615 No name Vol#: 725

C 9616 Georgette Drake Ergo Vol#: 725

C 9617 Gloria Kegeles Vol#: 725

C 9618 Gloria B Hogan Vol#: 725

C 9619 Bing Miller Vol#: 725

EMC 4498 Robert Danos Vol#: 725

01D-0129 Implementation of the Biomaterials Access Assurance Act

GDL 1 Draft Guidance for Industry and FDA Vol#: 1

NAD 1 Vol#: 1

01P-0122 To Remove False and Deceptive Labeling for Transderm Scop

C 1 Pharmacia Consumer Healthcare Inc. Vol#: 2