DOCKETS ENTERED on September 17, 2002

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 17, 2002

TABLE OF CONTENTS

Hyper links are part of the Docket title - not all dockets/documents are linked

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 ]

78N-036L OTC Laxative *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa *
00D-1539 Electronic Records & Signatures, Retention of Electronic Rec *
01N-0067 Reclassification of Dental Mercury*
01P-0120 Ban Unsafe IV Catheters and other Devices *
02N-0209 Governing First Amendment Case Law

78N-036L OTC Laxative

LET 197 American Herbal Products Assn. Vol#: 121

80N-0042 Anticaries Drug Products for OTC Human Use

MM 13 HFD-560 & Consumer Healthcare Prods. Ass Vol#: 36

88N-0038 Records & Reports concerning experience w/ new animal drugs

REF 1 HF-26 Vol#: 2

89V-0300 Miami Space Transit Laser Show

VRA 5 HFZ-300 to Miami Museum of Science & Spa Vol#: 1

97S-0162 30-Day Structure Function Claim Notification Letters Dietary

LET 9008 Natural Factors Nutritional Products Inc Vol#: 69

LET 9009 Natural Factors Nutritional Products Inc Vol#: 69

LET 9010 Natural Factors Nutritional Products Inc Vol#: 69

LET 9011 Natural Factors Nutritional Products Inc Vol#: 69

LET 9012 Natural Factors Nutritional Products Inc Vol#: 69

LET 9013 Natural Factors Nutritional Products Inc Vol#: 69

LET 9014 Natural Factors Nutritional Products Inc Vol#: 69

LET 9015 Natural Factors Nutritional Products Inc Vol#: 69

LET 9016 Natural Factors Nutritional Products Inc Vol#: 69

LET 9017 Natural Factors Nutritional Products Inc Vol#: 69

LET 9018 Natural Factors Nutritional Products Inc Vol#: 69

LET 9019 Natural Factors Nutritional Products Inc Vol#: 69

LET 9020 Natural Factors Nutritional Products Inc Vol#: 69

LET 9021 Pharmavite Corporation Vol#: 69

LET 9022 Natural Factors Nutritional Products Inc Vol#: 69

LET 9023 Natural Factors Nutritional Products Inc Vol#: 69

LET 9024 Natural Factors Nutritional Products Inc Vol#: 69

LET 9025 Natural Factors Nutritional Products Inc Vol#: 69

LET 9026 Natural Factors Nutritional Products Inc Vol#: 69

LET 9027 Natural Factors Nutritional Products Inc Vol#: 69

LET 9028 Natural Factors Nutritional Products Inc Vol#: 69

LET 9029 Natural Factors Nutritional Products Inc Vol#: 69

LET 9030 Natural Factors Nutritional Products Inc Vol#: 69

LET 9031 Natural Factors Nutritional Products Inc Vol#: 69

LET 9032 Natural Factors Nutritional Products Inc Vol#: 69

LET 9033 Natural Factors Nutritional Products Inc Vol#: 69

LET 9034 Natural Factors Nutritional Products Inc Vol#: 69

LET 9035 Natural Factors Nutritional Products Inc Vol#: 69

LET 9036 Natural Factors Nutritional Products Inc Vol#: 69

LET 9037 Natural Factors Nutritional Products Inc Vol#: 69

LET 9038 Natural Factors Nutritional Products Inc Vol#: 69

LET 9039 Natural Factors Nutritional Products Inc Vol#: 69

LET 9040 Natural Factors Nutritional Products Inc Vol#: 69

LET 9041 Natural Factors Nutritional Products Inc Vol#: 69

LET 9042 Natural Factors Nutritional Products Inc Vol#: 69

LET 9043 Natural Factors Nutritional Products Inc Vol#: 69

LET 9044 Natural Factors Nutritional Products Inc Vol#: 69

LET 9045 Natural Factors Nutritional Products Inc Vol#: 69

LET 9046 Natural Factors Nutritional Products Inc Vol#: 69

LET 9047 Natural Factors Nutritional Products Inc Vol#: 69

LET 9048 Natural Factors Nutritional Products Inc Vol#: 69

LET 9049 Natural Factors Nutritional Products Inc Vol#: 69

LET 9050 Natural Factors Nutritional Products Inc Vol#: 69

LET 9051 Natural Factors Nutritional Products Inc Vol#: 69

LET 9052 Natural Factors Nutritional Products Inc Vol#: 69

LET 9053 Natural Factors Nutritional Products Inc Vol#: 69

LET 9054 Natural Factors Nutritional Products Inc Vol#: 69

LET 9055 Natural Factors Nutritional Products Inc Vol#: 69

LET 9056 Natural Factors Nutritional Products Inc Vol#: 69

LET 9057 Natural Factors Nutritional Products Inc Vol#: 69

LET 9058 Natural Factors Nutritional Products Inc Vol#: 69

LET 9059 Natural Factors Nutritional Products Inc Vol#: 69

LET 9060 Natural Factors Nutritional Products Inc Vol#: 69

LET 9061 Natural Factors Nutritional Products Inc Vol#: 69

LET 9062 Natural Factors Nutritional Products Inc Vol#: 69

LET 9063 Natural Factors Nutritional Products Inc Vol#: 69

LET 9064 Natural Factors Nutritional Products Inc Vol#: 69

LET 9065 Natural Factors Nutritional Products Inc Vol#: 69

LET 9066 Solgar Vitamin & Herb Vol#: 69

LET 9067 Natural Organics Inc Vol#: 69

LET 9068 Vitamin Shoppe Industries Inc Vol#: 69

LET 9069 Natural Organics Inc Vol#: 69

LET 9070 Herbalist & Alchemist Inc Vol#: 69

LET 9071 Natural Organics Inc Vol#: 69

LET 9072 Natural Organics Inc Vol#: 69

LET 9073 Natural Organics Inc Vol#: 69

LET 9074 Natural Organics Inc Vol#: 69

LET 9075 Natural Organics Inc Vol#: 69

LET 9076 Natural Organics Inc Vol#: 69

LET 9077 Natural Organics Inc Vol#: 69

LET 9078 Natural Organics Inc Vol#: 69

LET 9079 Natural Organics Inc Vol#: 69

LET 9080 Natural Organics Inc Vol#: 69

LET 9081 Natural Organics Inc Vol#: 69

LET 9082 Natural Organics Inc Vol#: 69

LET 9083 Natural Organics Inc Vol#: 69

LET 9084 Natural Organics Inc Vol#: 69

LET 9085 Source Naturals Inc Vol#: 69

LET 9086 Vitamer Vol#: 69

LET 9087 Natural Organics Inc Vol#: 69

LET 9088 Vitamer Vol#: 69

LET 9089 Vitamer Vol#: 69

LET 9090 Vitamer Vol#: 69

LET 9091 Vitamer Vol#: 69

LET 9092 Vitamer Vol#: 69

LET 9093 Young Living Essential Oils Vol#: 69

LET 9094 PhytoPharmica Natural Medicines Vol#: 69

LET 9095 Enzymatic Therapy Inc Vol#: 69

LET 9096 NBTY Inc Vol#: 69

LET 9097 NBTY Inc Vol#: 69

LET 9098 NBTY Inc Vol#: 69

LET 9099 NBTY Inc Vol#: 69

LET 9100 NBTY Inc Vol#: 69

LET 9101 NBTY Inc Vol#: 69

LET 9102 NBTY Inc Vol#: 69

LET 9103 NBTY Inc Vol#: 69

LET 9104 NBTY Inc Vol#: 69

LET 9105 NBTY Inc Vol#: 69

LET 9106 NBTY Inc Vol#: 69

LET 9107 NBTY Inc Vol#: 69

LET 9108 NBTY Inc Vol#: 69

LET 9109 NBTY Inc Vol#: 69

LET 9110 NBTY Inc Vol#: 69

LET 9111 NBTY Inc Vol#: 69

LET 9112 NBTY Inc Vol#: 69

LET 9113 NBTY Inc Vol#: 69

LET 9114 NBTY Inc Vol#: 69

LET 9115 NBTY Inc Vol#: 69

LET 9116 NBTY Inc Vol#: 69

LET 9117 NBTY Inc Vol#: 69

LET 9118 NBTY Inc Vol#: 69

LET 9119 NBTY Inc Vol#: 69

LET 9120 NBTY Inc Vol#: 69

LET 9121 NBTY Inc Vol#: 69

LET 9122 NBTY Inc Vol#: 69

LET 9123 NBTY Inc Vol#: 69

LET 9124 NBTY Inc Vol#: 69

LET 9125 NBTY Inc Vol#: 69

LET 9126 NBTY Inc Vol#: 69

LET 9127 NBTY Inc Vol#: 69

LET 9128 NBTY Inc Vol#: 69

LET 9129 NBTY Inc Vol#: 69

LET 9130 NBTY Inc Vol#: 69

LET 9131 NBTY Inc Vol#: 69

LET 9132 NBTY Inc Vol#: 69

LET 9133 NBTY Inc Vol#: 69

LET 9134 NBTY Inc Vol#: 69

LET 9135 NBTY Inc Vol#: 69

LET 9136 NBTY Inc Vol#: 69

LET 9137 NBTY Inc Vol#: 69

LET 9138 NBTY Inc Vol#: 69

LET 9139 NBTY Inc Vol#: 69

LET 9140 NBTY Inc Vol#: 69

LET 9141 NBTY Inc Vol#: 69

LET 9142 NBTY Inc Vol#: 69

LET 9143 NBTY Inc Vol#: 69

LET 9144 NBTY Inc Vol#: 69

LET 9145 NBTY Inc Vol#: 69

LET 9146 NBTY Inc Vol#: 69

LET 9147 NBTY Inc Vol#: 69

LET 9148 NBTY Inc Vol#: 69

LET 9149 NBTY Inc Vol#: 69

LET 9150 Enzymatic Therapy Inc Vol#: 69

LET 9151 PhytoPharmica Natural Medicines Vol#: 69

LET 9152 Natural Organics Inc Vol#: 69

LET 9153 Dolisos America Inc Vol#: 69

LET 9154 NBTY Inc Vol#: 69

LET 9155 NBTY Inc Vol#: 69

LET 9156 NBTY Inc Vol#: 69

LET 9157 NBTY Inc Vol#: 69

LET 9158 NBTY Inc Vol#: 69

LET 9159 NBTY Inc Vol#: 69

LET 9160 NBTY Inc Vol#: 69

LET 9161 NBTY Inc Vol#: 69

LET 9162 NBTY Inc Vol#: 69

LET 9163 NBTY Inc Vol#: 69

LET 9164 NBTY Inc Vol#: 69

LET 9165 Balchem Corporation Vol#: 69

LET 9166 NBTY Inc Vol#: 69

LET 9167 NBTY Inc Vol#: 69

LET 9168 Trader Joe's Vol#: 69

LET 9169 Chattem Inc Vol#: 69

LET 9170 Tabak's HealthProducts Vol#: 69

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

EAPE1 Covington & Burling Vol#: 4

EAPE2 FDA/CVM Vol#: 4

EAPE3 FDA/CVM Vol#: 4

EAPE4 FDA Vol#: 4

EAPE5 CVM/FDA Vol#: 4

EAPE6 Phibro Animal Health Vol#: 4

EAPE7 Alltech Inc. Vol#: 4

EAPE8 Environmental Defense Vol#: 4

EAPE9 Food Animal Concerns Trust (FACT) Vol#: 4

EAPE10 Phibro Animal Health Vol#: 4

EAPE11 CVM Vol#: 4

EAPE12 National Pork Board Vol#: 4

EAPE13 National Pork Board Vol#: 4

EAPE14 Aerican Assoc of Swine Veterinarians Vol#: 4

EAPE15 National Pork Board Vol#: 4

EAPE16 Biotechnical Services, Inc. Vol#: 4

EAPE17 Animal Health Institute Vol#: 4

EAPE18 ECO Vol#: 4

EAPE19 Fac.Vet.Med. Vol#: 4

EC 1 student, UC Berkeley Vol#: 2

00D-1539 Electronic Records & Signatures, Retention of Electronic Rec

EC 1 Target Health Inc. Vol#: 6

EC 2 Number Not Used Vol#: 6

00V-1492 Laser Light Show

VRA 2 HFZ-330 to Red Line Inc. Vol#: 1

01N-0067 Reclassification of Dental Mercury

EMC 385 Sterling Prichard Vol#: 10

EMC 386 Barbara Wilkie Vol#: 10

EMC 387 Mary Ann Newell Vol#: 10

EMC 388 Beacon of Hope Foundation Vol#: 10

EMC 389 Ellen Ramsdale Vol#: 10

EMC 390 Rick Hall Vol#: 10

EMC 391 Kay Fincher Vol#: 10

EMC 392 Pamela J. Anderson Vol#: 10

EMC 393 Debra Seltenreich, R.N. Vol#: 10

EMC 394 Barbara Wilkie Vol#: 10

EMC 395 Carolyn Walker Vol#: 10

EMC 396 Susan Pinkus Vol#: 10

EMC 397 Mary Puff Vol#: 10

EMC 398 Mary Ann Newell Vol#: 10

EMC 399 Merrilee Pettinger Vol#: 10

EMC 400 Mary Ann Newell Vol#: 10

EMC 401 Charles G. Brown Vol#: 10

EMC 402 Consumers for Dental Choice Vol#: 10

EMC 403 Consumers for Dental Choice Vol#: 10

EMC 404 Consumers for Dental Choice Vol#: 10

EMC 405 Consumers for Dental Choice Vol#: 10

EMC 406 American Public Information on the Envir Vol#: 10

EMC 407 Toxics Action Center Vol#: 10

EMC 408 Juliene Lipson Vol#: 10

EMC 409 Dwight Florence Vol#: 10

EMC 410 Sarah Little, PhD Vol#: 10

EMC 411 Therese Quinn Vol#: 10

EMC 412 Shirley A. Garrett Vol#: 10

EMC 413 Peggy Wolff, MS, RNCS, CHN Vol#: 10

EMC 414 Mary Ann Newell Vol#: 10

EMC 415 Patricia Harris-Pascale Vol#: 10

EMC 416 K. Kendall Vol#: 10

EMC 417 Representative Hal Lynde Vol#: 10

EMC 418 Ellie Bowron Vol#: 10

EMC 419 Toni Peacock Vol#: 10

EMC 420 Carol Sterritt Vol#: 10

EMC 421 Toni Peacock Vol#: 10

EMC 422 Conusmers for Dental Choice Vol#: 10

EMC 423 Number Bot Used Vol#: 10

EMC 424 Consumers for Dental Choice Vol#: 10

EMC 425 Leslie Joy Smith Vol#: 10

EMC 426 Consumers for Dental Choice Vol#: 10

EMC 427 Consumers for Dental Choice Vol#: 10

EMC 428 Consumers for Dental Choice Vol#: 10

EMC 429 Sandra Wasrman Vol#: 10

EMC 430 Fred Lankering Vol#: 10

EMC 431 Reta Hanson Vol#: 10

EMC 432 Susan Booher Vol#: 10

EMC 433 Bobbie Dee Flowers Vol#: 10

EMC 434 Louis M. Mervis Vol#: 10

EMC 435 Deborah Elaine Barrie Vol#: 10

EMC 436 Katherine Duff Vol#: 10

EMC 437 Neil Martin Vol#: 10

EMC 438 Sanjay Tikku Vol#: 10

EMC 439 Ina Bransome Vol#: 10

EMC 440 Sybille B. Hartmann Vol#: 10

EMC 441 Mary Ann Newell Vol#: 10

EMC 442 Kathy Reilly, M.S., R.N. Vol#: 10

EMC 443 James Harrison, DDS Vol#: 10

EMC 444 Tracey Grubbs Vol#: 10

EMC 445 Consumers Health Freedom Coalition Vol#: 10

EMC 446 Health Care Without Harm Vol#: 10

EMC 447 Citizens for Health Freedom Vol#: 10

EMC 448 Mary Ann Newell Vol#: 10

EMC 449 Connie Pitts Vol#: 10

EMC 450 Clinton Zimmerman Vol#: 10

EMC 451 State Senator Don Benton Vol#: 10

EMC 452 Karen Truskowski Vol#: 10

EMC 453 State Representative Annie L. Key Vol#: 10

EMC 454 Jan McCoy Vol#: 10

EMC 455 James Harrison, DDS Vol#: 10

EMC 456 Cancer Research Center of America, Inc. Vol#: 10

EMC 457 Elizabeth Hopp Vol#: 10

EMC 458 Carolyn Dohrenwend Vol#: 10

EMC 459 Michael Framson Vol#: 10

EMC 460 Michael Framson Vol#: 10

EMC 461 Carolyn Dohrenwend Vol#: 10

EMC 462 Dick Dickerson Vol#: 10

EMC 463 Maryanne Rygg Vol#: 10

EMC 464 Robert Kulacz, DDS Vol#: 10

EMC 465 No signature Vol#: 10

EMC 466 Carol J. Ward Vol#: 10

EMC 467 No signature Vol#: 10

EMC 468 Rebecca L. Griffiths, BS, DMD Vol#: 10

EMC 469 Rebecca L. Griffiths, BS, DMD Vol#: 10

EMC 470 Maureen Halasovski Vol#: 10

EMC 471 Maureen Halasovski Vol#: 10

EMC 472 Lynette Schmidt Vol#: 10

EMC 473 Wanda Brown Vol#: 10

EMC 474 Karin Kelly-Givens Vol#: 10

EMC 475 Marta Sonnenblick Vol#: 10

EMC 476 Judith Stringer Vol#: 10

EMC 477 Alan L. Noelck, DDS Vol#: 10

EMC 478 Darleen R. Johnson Vol#: 10

EMC 479 Darleen R. Johnson Vol#: 10

EMC 480 Torrie Crocker Vol#: 10

EMC 481 J. Annette Flack Vol#: 10

EMC 482 Olemara Peters Vol#: 10

EMC 483 Marc D. Flack, DDS, FAGD Vol#: 10

EMC 484 Elisabet Carlsson Vol#: 10

EMC 485 Health Advocacy in the Public Interest Vol#: 10

EMC 486 Jytte Bengtsson Vol#: 10

EMC 487 Alvilda Jablonko Vol#: 10

EMC 488 Don Wetsel Vol#: 10

EMC 489 Pat Kultgen Vol#: 10

EMC 490 Lynn Romolini Vol#: 10

EMC 491 Stephen W. Carter Vol#: 10

EMC 492 Holistic Dental Assn Vol#: 10

EMC 493 No signature Vol#: 10

EMC 494 Jeffrey A. Nelson, DC Vol#: 10

EMC 495 Katie and Mike Briker Vol#: 10

EMC 496 Marjorie Monteleon Vol#: 10

EMC 497 Rebecca L. Griffiths, BS, DMD Vol#: 10

EMC 498 Bernice Rudelic Vol#: 10

EMC 499 David Kennedy, DDS Vol#: 10

EMC 500 Nancy Morris Vol#: 10

EMC 501 Nancy Haynes Vol#: 10

EMC 502 Mark A. Breiner, DDS Vol#: 10

EMC 503 Margaret Cruikshank, PhD Vol#: 10

EMC 504 Milton L. McIlwain, DDS, MDma, PhD Vol#: 10

EMC 505 Maine Toxics Action Coalition Vol#: 10

EMC 506 Mercury Poisoning Survivor Vol#: 10

EMC 507 Continental Resources, Inc. Vol#: 10

EMC 508 Pauline Reimers Vol#: 10

EMC 509 Maine DEP Vol#: 10

EMC 510 Odile Andreoli Vol#: 10

EMC 511 Ruth Zimmerman Vol#: 10

01P-0120 Ban Unsafe IV Catheters and other Devices

EC 14 Center for Health Outcomes and Policy Re Vol#: 1

EC 15 Cedars-Sinai Health System Vol#: 1

EC 16 eucomed Vol#: 1

EXT 1 Public Citizen Health Research Group Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 1128 Kay Myklebust Vol#: 221

C 1129 Kevin Stone Vol#: 221

C 1130 Steven McAllister Vol#: 221

C 1131 Bridget Brown Vol#: 221

C 1132 Eldon Simpson Vol#: 221

C 1133 Julie Machado, MFT Vol#: 221

C 1134 no signature Vol#: 221

C 1135 Violet C. Simpson Vol#: 221

C 1136 Ellen Howard Vol#: 221

C 1137 Jared McEntyre Vol#: 221

C 1138 Joyce J. Bauer Vol#: 221

C 1139 Drs. Herbert & Sondra Napell Vol#: 221

C 1140 John F. Dickinson Vol#: 221

C 1141 Jean Geissler Vol#: 221

C 1142 Dr. Mary Brenummun, M.D. & Paul Garcken Vol#: 221

C 1143 B. Oliver Vol#: 221

C 1144 George T. Riley Vol#: 221

C 1145 James C. Whiteside Vol#: 221

C 1146 Kevin D. Riley Vol#: 221

C 1147 David Zeff Vol#: 221

C 1148 Tim Boettcher Vol#: 221

C 1149 Laura Tye Vol#: 221

C 1150 Yvonne Logan Vol#: 221

EC 16 Camps Mondamin and Green Cove Vol#: 141

EMC 2416 Laine Vandal Vol#: 220

EMC 2417 Phyllis Beallor Vol#: 220

EMC 2418 Ileana Wyerman Vol#: 220

EMC 2419 Aleata Timmers Vol#: 220

EMC 2420 Josh Chiles Vol#: 220

EMC 2421 Michael John Mayo Vol#: 220

EMC 2422 K. England Vol#: 220

EMC 2423 Andrew Pender Vol#: 220

EMC 2424 Helen Tanguis Vol#: 220

02M-0412 PMA, GlucoWatch G2 Biographer, P990026/S008

AAV 1 Cygnus, Inc. Vol#: 1

02N-0209 Governing First Amendment Case Law

C 59 Association of Food and Drug Officials Vol#: 16

C 60 Mary R. Currier Vol#: 16

C 61 Judy Brasher Vol#: 16

C 62 Schering-Plough Vol#: 16

C 63 Association for Dressings & Sauces Vol#: 16

C 64 National Grain & Feed Assn. Vol#: 16

EC 411 Widener School of Law Vol#: 6

EC 412 Ms. Robin Moore Vol#: 6

EC 413 North Dakota Board of Pharmacy Vol#: 6

EC 414 Mr. Sim Wilkes Vol#: 6

EC 415 Mr. Jeff Granger Vol#: 6

EC 416 Mr. Noah Balmer Vol#: 6

EC 417 Ms. Cheryl A. Davis Vol#: 6

EC 418 Mercatus Center at George Mason Universi Vol#: 6

EC 419 Ms. Quincy Howard Vol#: 6

EC 420 Drug Enforcement Administration Vol#: 6

EC 421 American Feed Industry Association Vol#: 6

EC 422 Duke University Vol#: 6

EC 423 Ms. Antigoni Pappas Vol#: 6

EC 424 Association of Food and Drug Officials Vol#: 6

EC 425 Magazine Publishers of America Vol#: 6

EC 426 National Grain and Feed Association Vol#: 6

EC 427 Kronos Compounding Pharmacy Vol#: 6

EC 428 Ms. judith brody Vol#: 6

EC 429 American Herbal Products Association Vol#: 6

EC 430 West Chester University Vol#: 6

EC 431 n/a Vol#: 6

02V-0415 LAD-01 Medical Laser Product

ACK 1 HFA-305 Vol#: 1

VAR 1 Norwood Abbey Limited Vol#: 1