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 October 24, 2000

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 ]

 
75N-183H Health-Care Antiseptic Drug Products for OTC Human Use *
76N-052N OTC Nasal Decongestants *
78N-0301 OTC External Analgesic Drug Products *
78N-301F Fever Blister and Cold Core Treatment Drug Products *
83P-0187 REFRAIN FROM APPROVAL POLYURETHANE CONTRACEPTIVE SPONGE *
85N-0214 Drug Price Competition & Patent Term Restoration ACT 1984 *
94F-0405 Safe use of aspartame as general purpose sweetener *
96N-0393 MedWatch:FDA's Medical Prod Reporting Program Forms; Agency *
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs *
97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container *
98A-0912 FDA's Policy with Regards to Employee's Signature on Agency' *
98S-1064 The Implementation (MRA) between the United States & Europea *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-5106 Identify Sources of Natural Flavorings *
00D-1306 Content & Format of Prescription Drug Labeling *
00D-1384 Physical Examination of Surgeons' &/or Patient Exam Gloves *
00D-1385 Investigational Device Exemption (IDE's) & (PMA) *
00D-1392 Guidance for Industry on Botanical Drug Products *
00D-1401 Admin Procedures for Cinical Lab Improvement Amendment (CLIA *
00D-1497 Mammography Quality Standards Act; Final Regs Document #4 *
00N-0504 Egg Safety Action Plan *
00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair *
00N-1425 Human Tissue Intended for Transplantation *
00N-1463 Labeling Requirements for Systemic Antibacterial Drug Produc *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1564 Grant a temporrary exemption for one packaging component *
00P-1580 Listed drug withdrawn from sale; Drug product not marketed *

75N-183H Health-Care Antiseptic Drug Products for OTC Human Use

LET 18 The Soap & Detergent Association Vol#: 82

RPT 4 Lewis & Harrison Vol#: 83

76N-052N OTC Nasal Decongestants

ACK 3 HFA-305 Vol#: 73

C 234 Consumer Healthcare Products Assn (CHPA) Vol#: 73

C 235 Consumer Healthcare Products Assn (CHPA) Vol#: 73

CP 17 Public Citizen's Health Research Group Vol#: 73

EMC 1 Lynn Gold Vol#: 73

EMC 2 Lynn Gold Vol#: 73

78N-0301 OTC External Analgesic Drug Products

LET 88 HFD-560 to Chattem Inc. Vol#: 99

LET 89 HFD-560 to Bayer Corporation Vol#: 99

78N-301F Fever Blister and Cold Core Treatment Drug Products

LET 4 HFD-560 to Bayer Corporation Vol#: 1
 

81N-0022 OTC Weight Control Drug Products for Human Use

ACK 1 HFA-305 Vol#: 73

C 116 Consumer Healthcare Products Assn (CHPA) Vol#: 95

C 117 Consumer Healthcare Products Assn (CHPA) Vol#: 95

CP 19 Public Citizen's Health Research Group Vol#: 95

83P-0187 REFRAIN FROM APPROVAL POLYURETHANE CONTRACEPTIVE SPONGE

LET 7 Center for Drugs Evaluation & Research Vol#: 1

85N-0214 Drug Price Competition & Patent Term Restoration ACT 1984

C 73 Bristol Myers Squibb Co. Vol#: 27

94F-0405 Safe use of aspartame as general purpose sweetener

EMC 124 Kit Vol#: 3

96M-0311 Guideline on Infectious Disease Issues in Xenotransplantatio

N 2 HFA-250 Vol#: 20

96N-0393 MedWatch:FDA's Medical Prod Reporting Program Forms; Agency

C 28 MDS Nordion Science Advancing Health Vol#: 1

96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs

C 820 Kathy A Bradley Vol#: 31
 

96V-0077 Variance for Laser Light Show

EXP 1 Quantum Image Multimedia Productions Vol#: 1

97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container

C 9633 Glaxo Wellcome Vol#: 201
 

97P-0197 Require that warning labels about risks of salmonella enteri

C 821 Kathy A Bradley Vol#: 30

98A-0912 FDA's Policy with Regards to Employee's Signature on Agency'

APA 1 Policy Planning & Legislation Vol#: 1

98D-0969 Effects of antimicrobial new animal drugs/use in food-produc

EMC 3 Dr. Heather Gleaton Vol#: 16

98N-0970 Labeling for Menstrual Tampons

NFR 1 HFZ-215 Vol#: 1

98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell

C 820 Kathy A. Bradley Vol#: 32

98S-1064 The Implementation (MRA) between the United States & Europea

RPT 1 Grant Ramaley Vol#: 1

99D-4114 Testing for Replication Competent Retrovirus in Retroviral

GDL 2 Guideline Vol#: 1

NAD 2 HFM-17 Vol#: 1

99P-1340 Declared Eternity eau de Parfum Misbranded

EMC 190 J. Mac Vol#: 16

EMC 191 Kelly & Russ Seibert Vol#: 16

99P-5106 Identify Sources of Natural Flavorings

C 7 Judy Larson Vol#: 1

EMC 62 Pauline Fisher Vol#: 1

EMC 63 Miguel Vol#: 1

00D-1306 Content & Format of Prescription Drug Labeling

EMC 3 Blue Cross Blue Shield Assoc Vol#: 1

00D-1384 Physical Examination of Surgeons' &/or Patient Exam Gloves

C 2 Alliance Rubber Products Sdn. Bhd. Vol#: 1

C 3 Latex Manufacturing Vol#: 1

C 4 Allegiance Healthcare Corporation Vol#: 1

00D-1385 Investigational Device Exemption (IDE's) & (PMA)

C 1 Alcon Research, Ltd. Vol#: 1

00D-1392 Guidance for Industry on Botanical Drug Products

C 19 American Herbal Products Association Vol#: 2

00D-1401 Admin Procedures for Cinical Lab Improvement Amendment (CLIA

C 1 Mary Deason Vol#: 1

C 2 College of American Pathologists Vol#: 1

C 3 Roche Diagnostics Corporation Vol#: 1

C 4 American Academy of Family Physicians Vol#: 1

00D-1497 Mammography Quality Standards Act; Final Regs Document #4

C 1 University of California, Davis Vol#: 1

C 2 Oregon Health Sciences University Vol#: 1

C 3 Thomas Jefferson University Hospital Vol#: 1

C 4 Missouri Department of Health Vol#: 1

00N-0504 Egg Safety Action Plan

C 94 William R. Booth Vol#: 8

C 95 John & Frances McGarry Vol#: 8

C 96 The McTague Family Vol#: 8

C 97 Courtney A. Jay Vol#: 8

C 98 Bobbie Harms Vol#: 8

C 99 Karen A. Ferraro Vol#: 8

00N-1357 FDA Concept Paper:Demonstrably Difficult to Compound Drugs

C 19 CAPS, Central Admixture Pharmacy Service Vol#: 2

C 20 American Pharmaceutical Assn. Vol#: 2

C 21 Intl Academy of Compounding Pharmacists Vol#: 3

C 22 CollaGenex Pharmaceuticals, Inc. Vol#: 2

CR 1 Intl Academy of Compounding Pharmacists Vol#: 2

00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair

C 27 Advanced Medical Technology Association Vol#: 2

00N-1425 Human Tissue Intended for Transplantation

C 1 Eye Bank Association of America Vol#: 1

00N-1463 Labeling Requirements for Systemic Antibacterial Drug Produc

C 1 Sousan S. Altaie Vol#: 3

C 2 Harold V. Silver Vol#: 3

C 3 Frederic Marsik Vol#: 3

EMC 1 Ronald O White Pharm D Vol#: 1

00N-1520 Labeling of Menstrual Tampons: Ranges of Absorbency

NPR 1 HFZ-215 Vol#: 1

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

C 6841 Nicole D Martin Vol#: 298

EMC 3421 Emil Bartok Vol#: 299

EMC 3422 Jim Trapp Vol#: 299

EMC 3423 Marcia Leadbetter Vol#: 299

EMC 3424 Kathryn L Bardsley Vol#: 299

EMC 3425 Mary S Reed Vol#: 299

EMC 3426 Michael Crase Vol#: 299

EMC 3427 Michole Norton Vol#: 299

EMC 3428 Peter Lukow Vol#: 299

EMC 3429 Michael McCrary Vol#: 299

EMC 3430 Richard Grove Vol#: 299

EMC 3431 Steven Meallo Vol#: 299

EMC 3432 Kim Pratt Vol#: 299

EMC 3433 Irma Culotta Vol#: 299

EMC 3434 Michelle Novotny Vol#: 299

EMC 3435 Michael Cohen Vol#: 299

EMC 3436 Alexander Adelsberger Vol#: 299

EMC 3437 Tony Cortez Vol#: 299

EMC 3438 Greg Hunter Vol#: 299

EMC 3439 Tobias Kienie Vol#: 299

EMC 3440 Janie Schaffner Vol#: 299

EMC 3441 Sue Johnson Vol#: 299

EMC 3442 Eric Johnson Vol#: 299

EMC 3443 Jodie Guerin Vol#: 299

EMC 3444 Lisa DeVaney Vol#: 299

EMC 3445 Arch McCulloch Vol#: 299

EMC 3446 Donna Hoaglin Vol#: 299

EMC 3447 Jonothan L Logan Vol#: 299

EMC 3448 Chris Fischetti Vol#: 299

EMC 3449 Pam Pinto Vol#: 299

EMC 3450 Waltraud Raninger Vol#: 299

EMC 3451 Robert Bliss Vol#: 299

EMC 3452 Jennifer Papa Vol#: 299

EMC 3453 Susan Mack Vol#: 299

EMC 3454 Nancy Lee Melmon Vol#: 299

EMC 3455 Judith I Leavitt Vol#: 299

EMC 3456 Pat Gula Vol#: 299

EMC 3457 Michael Allen Vol#: 299

EMC 3458 Leta Rosetree Vol#: 299

EMC 3459 Dawn Szelc Vol#: 299

EMC 3460 Jason Jones Vol#: 299

EMC 3461 Ed Weibe Vol#: 299

EMC 3462 Linda Tagliaferro Vol#: 299

EMC 3463 Richard Mason Vol#: 299

EMC 3464 Debora Eldred Vol#: 299

EMC 3465 Majken Woods Vol#: 299

EMC 3466 John Nyboer Vol#: 299

EMC 3467 Marina Skumanich Vol#: 299

EMC 3468 Clarissa Avila Vol#: 299

EMC 3469 Sherri Loveland Vol#: 299

EMC 3470 April Schwass Vol#: 299

EMC 3471 Tim Aden Vol#: 299

EMC 3472 Deborah Jones Vol#: 299

EMC 3473 Tonya Haff Vol#: 299

EMC 3474 Janet Cook Vol#: 299

EMC 3475 Mary White Vol#: 299

EMC 3476 Noah Nakell Vol#: 299

EMC 3477 Diane Sceisi Vol#: 299

EMC 3478 Kathy Harney Vol#: 299

EMC 3479 Martin Rojo Vol#: 299

EMC 3480 Denise Bestwick Vol#: 299

EMC 3481 Swan Kellogg Vol#: 299

EMC 3482 Merie Blugh Vol#: 299

EMC 3483 Randall Braden Vol#: 299

EMC 3484 Linda Kosmalski Vol#: 299

EMC 3485 Darcy Danielson Vol#: 299

EMC 3486 Judy Feather Vol#: 299

EMC 3487 Michlyn Zagar Vol#: 299

EMC 3488 PM Pallas Vol#: 299

EMC 3489 Jodi Forbes Vol#: 299

EMC 3490 Kathy Cullen Vol#: 299

EMC 3491 Jeanne Dworin Vol#: 299

EMC 3492 Tom Costello Vol#: 299

EMC 3493 Dennis Lillis Vol#: 299

EMC 3494 Susan Waldman Vol#: 299

EMC 3495 Eirik Breininger Vol#: 299

EMC 3496 Charles Kempton Dr Vol#: 299

EMC 3497 Gail Ora Vol#: 299

EMC 3498 Miles Dempsey Vol#: 299

EMC 3499 Sarah Carey Vol#: 299

EMC 3500 Virginia Carison Vol#: 299

EMC 3501 Betty Taylor Vol#: 299

EMC 3502 Sallie Williams Vol#: 299

EMC 3503 Sheila Valentine Vol#: 299

EMC 3504 Ellice Heaston Vol#: 299

EMC 3505 Lynn Johnson Vol#: 299

EMC 3506 Seth Colitz Vol#: 299

EMC 3507 Orestes Yambouranis Vol#: 299

EMC 3508 Sharon Spontak Vol#: 299

EMC 3509 Jonathan Janssen Vol#: 299

EMC 3510 Christy Becker Vol#: 299

EMC 3511 Mary Marshall Vol#: 299

EMC 3512 Karin Ucci-Peddie Vol#: 299

EMC 3513 Nicole Mauriello Vol#: 299

EMC 3514 Bonnie Fikel Vol#: 299

EMC 3515 Wm Fleming Vol#: 299

EMC 3516 Michael Potter Vol#: 299

EMC 3517 R Kunz Vol#: 299

EMC 3518 R Kunz Vol#: 299

EMC 3519 David McGinley Vol#: 299

EMC 3520 Roger Larson Vol#: 299

EMC 3521 Gie Swinnen Vol#: 299

EMC 3522 Angel Torres Vol#: 299

EMC 3523 Michael Amato Vol#: 299

EMC 3524 Mary Landale Vol#: 299

EMC 3525 Patrick Sumner Vol#: 299

EMC 3526 Diana Wilson Vol#: 299

EMC 3527 Tina Konotos Vol#: 299

EMC 3528 Chris Munro Vol#: 299

EMC 3529 Julia Henry Vol#: 299

EMC 3530 Tammy Ryan Vol#: 299

EMC 3531 Thomas Neuhaus Vol#: 299

EMC 3532 Alvin Schlangen Vol#: 299

EMC 3533 Jymie Sampsel Vol#: 299

EMC 3534 Garrett Quinn Vol#: 299

EMC 3535 Michael LeVesque Vol#: 299

EMC 3536 S White Vol#: 299

EMC 3537 Sarah Glover Vol#: 299

EMC 3538 Shawn Breen Vol#: 299

EMC 3539 Allison Williams Vol#: 299

EMC 3540 Mel McPherson Vol#: 299

EMC 3541 Paul Edwards Vol#: 299

EMC 3542 Phil Morris Vol#: 299

EMC 3543 Francine Kohn Vol#: 299

EMC 3544 Candy Brenner Vol#: 299

EMC 3545 Ramona Waugh Vol#: 299

EMC 3546 Matthew Vasquez Vol#: 299

EMC 3547 Denise Barton Vol#: 299

EMC 3548 Elizabeth Sinkey Vol#: 299

EMC 3549 Maria Vazquez-Rest Vol#: 299

EMC 3550 Dean Luurtsema Vol#: 299

EMC 3551 Sue Kropp Vol#: 299

EMC 3552 Judith Canepa Vol#: 299

EMC 3553 Eric Johnson Vol#: 299

EMC 3554 Patricia Rodgers Vol#: 299

EMC 3555 Patricia Scott Vol#: 299

EMC 3556 Elizabeth Marshall Vol#: 299

EMC 3557 Nancy Short Vol#: 299

EMC 3558 Judith Canepa Vol#: 299

EMC 3559 Megan DeSmedt Vol#: 299

EMC 3560 Gregory Deean Vol#: 299

EMC 3561 Fiona Weiss Vol#: 299

EMC 3562 Kaleena Otey Vol#: 299

EMC 3563 David Bradley Vol#: 299

EMC 3564 Marie I Cochran Vol#: 299

EMC 3565 David Bell Vol#: 299

EMC 3566 Cindy Thompson Vol#: 299

00P-1280 Exempt Devices Classified as Total Triiodothyronine Test Sys

NFR 1 HFZ-404 Vol#: 1

00P-1564 Grant a temporrary exemption for one packaging component

ACK 1 HFA-305 Vol#: 1

00P-1580 Listed drug withdrawn from sale; Drug product not marketed

ACK 1 HFA-305 Vol#: 1

CP 1 Lachman Consultant Services Inc Vol#: 1

00V-1581 Laser light show

ACK 1 HFA-305 Vol#: 1

VAR 1 Club Europe Vol#: 1