Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870; TTY/TDD Users 1-800-735-2258 - [E-mail Us]

DOCKETS ENTERED on September 13, 2002

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-0053 Reprocessing&Reuse of Single-Use Devices/Risk Categorization *
00N-1571 Enrofloxacin for Poultry: Opportunity for hearing *
00P-1322 Food Labeling and Allergen Contamination Control *
01N-0067 Reclassification of Dental Mercury *
01P-0120 Ban Unsafe IV Catheters and other Devices *
02D-0228 Implantable Middle Ear Hearing Device *
02D-0326 Safety of Residues of Veterinary Drugs in Human Food *
02N-0209 Governing First Amendment Case Law *
02N-0383 Veterinary Adverse Drug Reaction; Product Defect Report *
02P-0317 Recall Aspartame as a Neurotoxic Drug *
02P-0413 Health Claim: Phosphatidylserine and cognitive dysfunction *

98D-1146 Microbial effects of antimicrobial new animal drugs/human sa

GDL 1 GUIDANCE Vol#: 2

NAD 2 Vol#: 2

NM 1 Vol#: 2

99D-4575 New Use Food Contact Substance Notification System-Chemistry

EC 1 Number Not Used Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

EMC 884 Rebecca McIntosh Vol#: 212

00D-0053 Reprocessing&Reuse of Single-Use Devices/Risk Categorization

EC 4 Murray-Calloway County Hospital Vol#: 5

EC 5 IAHCSMM Vol#: 5

EC 6 Ms. Susanne Sanders Vol#: 5

EC 7 HEALTHSOUTH Vol#: 5

EC 8 RHD & Trinity Medical Centers Vol#: 5

EC 9 Group Health Cooperative of Puget Sound Vol#: 5

EC 10 Ms. Shari Moore Vol#: 5

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

EMC 9 Melissa Moncavage Vol#: 5

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

MO 14 Bayer Corporation Vol#: 270

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

C 12676 Helen R Reutlinger Vol#: 785

C 12677 Catherine Freidman Vol#: 785

C 12678 Rachel Kio Vol#: 785

EMC 5320 Tegwyn Bath Vol#: 785

EMC 5321 Laurie Heriz-Smith Vol#: 785

EMC 5322 Hugo Heriz-Smith Vol#: 785

EMC 5323 Laura O. Schmidt Vol#: 785

EMC 5324 Marcello Lanfranchi Vol#: 785

EMC 5326 John Demet Vol#: 785

EMC 5327 Cesar Goncalves Vol#: 785

EMC 5328 Roland Press Vol#: 785

EMC 5329 Peter Clark Vol#: 785

EMC 5330 Terri Madden Vol#: 785

EMC 5331 Shannon Gaida Vol#: 785

EMC 5332 Andrea Martin Vol#: 785

EMC 5333 Loraine Hill Vol#: 785

EMC 5334 Jenny Holub Vol#: 785

EMC 5335 Cal Hill Vol#: 785

EMC 5336 Susan Levine Vol#: 785

EMC 5337 Jeffrey Grayson Vol#: 785

EMC 5338 Gloria Larkin Vol#: 785

EMC 5339 Jodie Leidecker Vol#: 785

EMC 5340 Belinda Heaton Vol#: 785

EMC 5341 Lydia Straus-Edwards Vol#: 785

EMC 5342 Kelli Gray Vol#: 785

EMC 5343 Patricia Leavitt Vol#: 785

EMC 5344 Linda Price Vol#: 785

EMC 5345 Janus Wilhelm Vol#: 785

00P-1322 Food Labeling and Allergen Contamination Control

ANS 8 HF-22 to Honorable Jake Reed Vol#: 29

01N-0067 Reclassification of Dental Mercury

ANS 4 HF-22 to Honorable Chet Edwards Vol#: 8

ANS 5 HF-22 to Honorable Gordan H. Smith Vol#: 8

ANS 6 HF-22 to Honorable Herbert Kohl Vol#: 8

C 51 Marilynn Carter Vol#: 8

C 52 Ronlad W. Niklaus, D.M.D. MAGD Vol#: 8

C 53 Sean Hinckley Vol#: 8

C 54 John Costa Vol#: 8

EMC 378 Carolyn Alter, PT, CMPT Vol#: 6

EMC 379 Judith Trustone Vol#: 6

EMC 380 No signature Vol#: 6

EMC 381 Franklin H. Ross, Jr., MD Vol#: 6

EMC 382 Debbie Pettigrew Vol#: 6

EMC 383 Andrea Cheryl Holman Vol#: 6

EMC 384 Jennifer Gosse Vol#: 6

HER 2 Consumers for Dental Choice, Inc. Vol#: 8

01N-0322 Institutional Review Boards

EMC 21 Morris Berger, M.Sc Vol#: 1

01P-0120 Ban Unsafe IV Catheters and other Devices

C 5 Assn of Needle-Free Injection Manufactur Vol#: 1

EMC 1 American Society of Anesthesiology (ASA) Vol#: 1

EMC 2 American Society of Anesthesiology (ASA) Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

EC 15 Mrs. Constance Frederickson Vol#: 141

EMC 2365 Alexa Olivo Vol#: 220

EMC 2366 Jill Owens Vol#: 220

EMC 2367 Larry Zwolinski Vol#: 220

EMC 2368 Susan Courrejou Vol#: 220

EMC 2369 Harriet V. Loesch Vol#: 220

EMC 2370 Gerri Kolesar Vol#: 220

EMC 2371 Jean Gallup Vol#: 220

EMC 2372 Thomas Windberg Vol#: 220

EMC 2373 Jyllian Smolev Vol#: 220

EMC 2374 Rebecca Shedd Vol#: 220

EMC 2375 Andrew Bodenbender Vol#: 220

EMC 2376 Bert Fernandez MD. & Elizabeth Fernandez Vol#: 220

EMC 2377 Janice Owens Vol#: 220

EMC 2378 Sharon Paquin-Gilmore Vol#: 220

EMC 2379 Susanna de Falla Vol#: 220

EMC 2380 Carol Miseo-Hardin Vol#: 220

EMC 2381 Charmaine Eliason Vol#: 220

EMC 2382 Holly Hallman Vol#: 220

EMC 2383 Sara Kube Vol#: 220

EMC 2384 Dr. Kristofer Young, DC Vol#: 220

EMC 2385 Marilyn Dinger Vol#: 220

EMC 2386 M. Salas Vol#: 220

EMC 2387 Deborah Rikoon Vol#: 220

EMC 2388 James Scheidt Vol#: 220

EMC 2389 Harold Feick Vol#: 220

EMC 2390 Loraine Hutchins, Ph.D. Vol#: 220

EMC 2391 Ms. Margaret Hanon Vol#: 220

EMC 2392 Gabrielle Wellman Vol#: 220

EMC 2393 David A. Belkiewitz Vol#: 220

EMC 2394 Jill Bobbins Vol#: 220

EMC 2395 Mary Ann Orzechowski Vol#: 220

EMC 2396 Pamela Jones Vol#: 220

EMC 2397 Diana Bishop Vol#: 220

EMC 2398 Patricia L. Lent Vol#: 220

EMC 2399 Lucille Nurkse Vol#: 220

EMC 2400 Maire Osborn Vol#: 220

EMC 2401 Angel Funk Vol#: 220

EMC 2402 Anthony Bandy-Zalatoris Vol#: 220

EMC 2403 Marla Pelz Vol#: 220

EMC 2404 Mitchell Solovay, RN Vol#: 220

EMC 2405 Anne Nadler Groser Vol#: 220

EMC 2406 Edward M. Oberweiser Vol#: 220

EMC 2407 number not used Vol#: 220

EMC 2408 Alex Casalboni Vol#: 220

EMC 2409 Kara Fosbender Vol#: 220

EMC 2410 Ivan Greene Vol#: 220

EMC 2411 Lynn Houston Vol#: 220

EMC 2412 Gaby Hemphill Vol#: 220

EMC 2413 Beverly Ellingwood Vol#: 220

EMC 2414 Loretta Hymel Vol#: 220

EMC 2415 Gary Hymel Vol#: 220

02D-0073 Validation of Procedures for Processing of Human Tissues

EC 2 Mr. William Black Vol#: 1

02D-0228 Implantable Middle Ear Hearing Device

EC 1 American Academy of Audiology Vol#: 1

EC 2 Lake County Hearing Clinic Vol#: 1

02D-0326 Safety of Residues of Veterinary Drugs in Human Food

EMC 1 SCIREX Corporation Vol#: 1

EMC 2 SCIREX Corporation Vol#: 1

02D-0368 Safety of Residues of Veterinary Drugs In Human Food

EMC 1 SCIREX Corporation Vol#: 1

EMC 2 SCIREX Corporation Vol#: 1

02E-0023 Patent Term Application for Definity No. 5,527,521

EC 1 Ms. Liesl Wright Vol#: 1

02N-0102 Notification of a health claim based Authoritative Statement

SS 1 SUPPORTING STATEMENT Vol#: 1

02N-0209 Governing First Amendment Case Law

C 25 Eligible Vol#: 5

C 26 Vernon P. Urquhart Vol#: 5

C 27 Bens Frumen Vol#: 5

C 28 National Foods Assn (NNFA) Vol#: 5

C 29 Boston Scientific Corporation Vol#: 5

C 30 Arnall Golden Gregory, LLP Vol#: 5

C 31 American Bakers Assn (ABA) Vol#: 5

EC 345 Mrs. Alice Peters Vol#: 6

EC 346 Mr. Robert Cote Vol#: 6

EC 347 Mr. Brian Smith Vol#: 6

EC 348 Dr. Christie Amato Vol#: 6

EC 349 Kaiser Permanente Center for Health Rese Vol#: 6

EC 350 Mr. george swilley Vol#: 6

EC 351 Mr. Alan Lester Vol#: 6

EC 352 Dr. Frann Michel Vol#: 6

EC 353 Ms. Katie McCarthy Vol#: 6

EC 354 Mr. John Lindhe Vol#: 6

EC 355 Security On Campus, Inc. Vol#: 6

EC 356 Mr. Gregg Holbert Vol#: 6

EC 357 Mr. Charles Dunaway Vol#: 6

EC 358 Ms. Christine Clemens Vol#: 6

EC 359 Mr. Christopher Lauderdale Vol#: 6

EC 360 Mr. Thomas Evans Vol#: 6

EC 361 Baylor College of Medicine Vol#: 6

EC 362 Mr. Jim Klosterman Vol#: 6

EC 363 Ms. Liesl Wright Vol#: 6

EC 364 Law Office of Paul R. Lehto Vol#: 6

EC 365 Ms. Sharon Novak Vol#: 6

EC 366 Ms. BARBARA HILL Vol#: 6

EC 367 Dr. Ray Pfeiffer Vol#: 6

EC 368 Mr. David Torres Vol#: 6

EC 369 Mr. Brian Seymour Vol#: 6

EC 370 Mr. Lawrence Grasso Vol#: 6

EC 371 Mr. Jeff Nale Vol#: 6

EC 372 Mr. R. Neal Bell Vol#: 6

EC 373 Mrs. Susan F. Rogers Vol#: 6

EC 374 Mr. Mark Makino Vol#: 6

EC 375 Mr. Jonathan Bines Vol#: 6

EC 376 Mr. Bryce Benson Vol#: 6

EC 377 Mr. Jason Bunch Vol#: 6

EC 378 Mr. Richard Pratt Vol#: 6

EC 379 Dr. Reginald Gibbons Vol#: 6

EC 380 Ms. Sue Kangiser Vol#: 6

EC 381 Mr. Charles Hoagland Vol#: 6

EC 382 John A. Weeks, MD Family Practice Vol#: 6

EC 383 Mr. John Ramsey Vol#: 6

EC 384 Mr. Anthony Shore Vol#: 6

EC 385 The Oker Institute Vol#: 6

EC 386 ACME CD Mfg. Vol#: 6

EC 387 Mr. Ryan Scott Vol#: 6

EC 388 Mr. Salvatore Russo Vol#: 6

EC 389 Mr. Kevin Mendenhall Vol#: 6

EC 390 Ms. Denise Lankau Vol#: 6

EC 391 University of California Library Vol#: 6

EC 392 Mr. Deitrich Zook Vol#: 6

EC 393 Ms. Jeannette Baker Vol#: 6

EC 394 Vanguard Vol#: 6

EC 395 Mr. Josh Smith Vol#: 6

EC 396 Ms. jill peterson Vol#: 6

EC 397 Ms. Sue Reilly Vol#: 6

EC 398 Mr. Tom McCarty Vol#: 6

EC 399 Mrs. Neenah Estrella-Luna Vol#: 6

EC 400 Mr. Michael Sedik Vol#: 6

EC 401 Mr. Michael Freedman-Schnapp Vol#: 6

EC 402 Mr. Brian Berger Vol#: 6

EC 403 Ms. Jeanne Peppard Vol#: 6

EC 404 New Mexico Public Interest Research Grou Vol#: 6

EC 405 Mr. Kurt Kiebler Vol#: 6

EC 406 Ms. Christine Jolley Vol#: 6

EC 407 Mr. Fritz Herrick Vol#: 6

EC 408 Ms. Judith Merrill-Smith Vol#: 6

EC 409 None Vol#: 6

EC 410 Mrs. Christine Henriksson Vol#: 6

EMC 29 Form Letter Vol#: 7

EMC 30 Addie Pobst Vol#: 9

EMC 31 Paul Manning Vol#: 9

EMC 32 Edwin T. Story Vol#: 9

EMC 33 Amanda Hillery Vol#: 9

EMC 34 Dennis Hans Vol#: 9

EMC 35 Anita Newman Vol#: 9

EMC 36 Jennifer Kreger, MD Vol#: 9

EMC 37 Susan Garrad Vol#: 9

EMC 38 Thomas G. Pretlow, PhD Vol#: 9

EMC 39 Sarah Smith Redmond Vol#: 9

EMC 40 Mary E. Seabloom Vol#: 9

EMC 41 Mike Troft Vol#: 9

EMC 42 Jack Mevorach Vol#: 9

EMC 43 Joan Almon Vol#: 9

EMC 44 Robert Vogel Vol#: 9

EMC 45 Angela Paschall Vol#: 9

EMC 46 Andy Bach Vol#: 9

EMC 47 Babara Phinney & Brent McFarlane Vol#: 9

EMC 48 David DiPasquale Vol#: 9

EMC 49 Angel Papini Vol#: 9

EMC 50 Temsy Chen Vol#: 9

EMC 51 No signature Vol#: 9

EMC 52 Michael Randle Vol#: 9

EMC 53 Sherri Mann Vol#: 9

EMC 54 Wade Wainio Vol#: 9

EMC 55 James Cox Vol#: 9

EMC 56 John K. Hilpp Vol#: 9

EMC 57 Ann Henning Vol#: 9

EMC 58 Shelly Casto Vol#: 9

EMC 59 Rick Zmiejko Vol#: 9

EMC 60 Kenneth W. Graham, Jr. Vol#: 9

EMC 61 David Nixon Vol#: 9

EMC 62 Paul Wilkins Vol#: 9

EMC 63 Mary Jane Dodd Vol#: 9

EMC 64 Joel Cummings Vol#: 9

EMC 65 Kevin S. Decker Vol#: 9

EMC 66 Jay Sweeney Vol#: 9

EMC 67 Katherine Williams Vol#: 9

EMC 68 Ben Erickson Vol#: 9

EMC 69 Judy M. Jensvold Vol#: 9

EMC 70 Peter Seidman Vol#: 9

EMC 71 Raquel Bournhonesque Vol#: 9

EMC 72 Sonya Zalubowski Vol#: 9

EMC 73 Eileen Flaxman Vol#: 9

EMC 74 Brendan J. Pezzoli Vol#: 9

EMC 75 Mark M. Giese Vol#: 9

EMC 76 Sarah Butler Vol#: 9

EMC 77 Catherine Sammons Vol#: 9

EMC 78 Jennifer Talarico Vol#: 9

EMC 79 DeeDee Lynn Vol#: 9

EMC 80 Barbara Brown Vol#: 9

EMC 81 Michelle Smith Vol#: 9

EMC 82 No signature Vol#: 9

EMC 83 Joe Kelly Vol#: 9

EMC 84 Cathryn Raphael Cordray Vol#: 9

EMC 85 Tad Goguen Frantz, RN, PhD Vol#: 9

EMC 86 Joseph Strebler Vol#: 9

EMC 87 Joseph Strebler Vol#: 9

EMC 88 Michelle Quigley Vol#: 9

EMC 89 Laura Catherine D. Fortune Vol#: 9

EMC 90 Thom Copeland Vol#: 9

EMC 91 Andrew Carotehrs-Liske Vol#: 9

EMC 92 No signature Vol#: 9

EMC 93 Matthew Johnson Vol#: 9

EMC 94 Jodi L. Eckel Cifrese Vol#: 9

EMC 95 David LeLand Vol#: 9

EMC 96 Denise Phillips Vol#: 9

EMC 97 Jacob Daniel Vol#: 9

EMC 98 Jeanette Longfield Vol#: 9

EMC 99 Roxanne Tebow Vol#: 9

EMC 100 Bradley H. Boe Vol#: 9

EMC 101 John Cannon Vol#: 9

EMC 102 Bruce Bickham Vol#: 9

EMC 103 Joanna Shelton Vol#: 9

EMC 104 Margo Johnson Vol#: 9

EMC 105 Carol Davidek-Waller Vol#: 9

EMC 106 Liz Schwartz Vol#: 9

EMC 107 Joseph Casey Vol#: 9

EMC 108 Joel Lexchin, MD Vol#: 9

EMC 109 Joanne Denning Vol#: 9

EMC 110 Steven Friedman Vol#: 9

EMC 111 Jennifer Hollowell Vol#: 9

EMC 112 La Vergne Rosow Vol#: 9

EMC 113 Richard Hawley Vol#: 9

EMC 114 Peggie Feddersen Vol#: 9

EMC 115 Dr. Larry Shotland Vol#: 9

EMC 116 No signature Vol#: 9

EMC 117 Amy Grace Vol#: 9

EMC 118 Annemarie Colbin, PhD Vol#: 9

EMC 119 Sarah J. Vokes Vol#: 9

EMC 120 Karl R. Hubrt Vol#: 9

EMC 121 Mark J. Allen Vol#: 9

EMC 122 Ronald G. Glaessgen Vol#: 9

EMC 123 Rich Kelly Vol#: 9

EMC 124 Tim Kasser, PhD Vol#: 9

EMC 125 Dr. Lin Kaatz Chary Vol#: 9

EMC 126 Jeff Howard Vol#: 9

EMC 127 Daal Praderas Vol#: 9

EMC 128 David Donielson, M.D. Vol#: 9

EMC 129 Dale W. Work Vol#: 9

EMC 130 Hope Damon, R.D., CDE Vol#: 9

EMC 131 Andrew L. Brown, Jr. Vol#: 9

EMC 132 Wendy Miller Vol#: 9

EMC 133 Form Letters Vol#: 8

EMC 134 M. Addison Amos Vol#: 9

EMC 135 Nathan Cambridge Vol#: 9

EMC 136 Joyce Lafferty Vol#: 9

EMC 137 Jason Reynolds Vol#: 9

EMC 138 R. Richard Valencia Vol#: 9

EMC 139 Katie Best Vol#: 9

EMC 140 Steve Dixon Vol#: 9

EMC 141 No signature Vol#: 9

EMC 142 Ana Micka Vol#: 9

EMC 143 Alex Pappas Vol#: 9

EMC 144 No signature Vol#: 9

EMC 145 MASSPIRG (Massachusetts Public Interest Vol#: 9

EMC 146 Carey Dabney Vol#: 9

EMC 147 Jen Seals Vol#: 9

02N-0383 Veterinary Adverse Drug Reaction; Product Defect Report

EC 1 ORGANIZATION FOR A NEW EASTSIDE Vol#: 1

02P-0317 Recall Aspartame as a Neurotoxic Drug

EMC 6 Mission Possible International Vol#: 1

EMC 7 Mission Possible International Vol#: 1

EMC 8 Mission Possible International Vol#: 1

EMC 9 Mission Possible International Vol#: 1

EMC 10 Mission Possible International Vol#: 1

EMC 11 Mission Possible International Vol#: 1

EMC 12 Sherri Lex Vol#: 1

EMC 13 Betty Martini Vol#: 1

EMC 14 Leoloa Barry Vol#: 1

EMC 15 Mission Possible International Vol#: 1

02P-0413 Health Claim: Phosphatidylserine and cognitive dysfunction

CP 1 Kyl Smith, D.C. Vol#: 1

LET 1 GCF-1 to Emord & Associates Vol#: 6

LET 2 Emord & Associates, P.C. Vol#: 6

LET 3 Emord & Associates, P.C. Vol#: 6

SUP 1 Emord & Associates, P.C. Vol#: 6