Food and Drug AdministrationDockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, 
Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870

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DOCKETS ENTERED on August 9, 2000

TABLE OF CONTENTS

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80N-0042 Anticaries Drug Products for OTC Human Use *
88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE *
92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992 *
98F-0165 safe use of ionizing radition for reduction of salmonella *
00D-1307 Parathyroid Hormone/Prevention & Treatment of Osteoporosis *
00D-1309 Channels trade policy commodities with methyl parathion *
00D-1393 Screening tests labeled for use w/ Cadaveric blood Specimens *
00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00V-1405 Telemetry transmitter cable *

80N-0042 Anticaries Drug Products for OTC Human Use

MM 12 HFD-560 & Warner-Lambert Co. Vol#: 318

88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE

C 136 American Red Cross Vol#: 5

92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992

C 121 American Red Cross Vol#: 5
 
 

95G-0009 Safe Use of Whey Protein Isolate & Dairy Products Solids

NWL 1 Vol#: 1
 
 

98D-1165 510(K)'s for Extracorporeal Shock Wave Lithotripters

GDL 2 Guideline 2 Vol#: 1

NAD 2 HFZ-215 Vol#: 1

98F-0165 safe use of ionizing radition for reduction of salmonella

C 3 United Poultry Concerns, Inc Vol#: 1
 
 

98N-1134 Reclassification of Extracorporeal Shock Wave Lithotripter

BKG 2 Background material Vol#: 1

NFR 1 HFZ-215 Vol#: 3
 
 

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

C 14425 Dolores Bertotti Vol#: 437

C 14426 Jodi Lucas Vol#: 437

C 14427 Mardo Jones Vol#: 437

C 14428 Sarah Dixon Vol#: 437

C 14429 Barbara Babcock Vol#: 437

C 14430 Janet T. Shishido Vol#: 437

C 14431 G. W. Schoen Vol#: 437

C 14432 Rose Javier Vol#: 437

C 14433 Janna S. Mintz Vol#: 437

C 14434 Mytzi Stoumbos Vol#: 437

C 14435 Linda L. Gammon Vol#: 437

C 14436 Richard Lee Brown Vol#: 437

C 14437 Dee Thompson Vol#: 437

C 14438 Elizabeth Bell Vol#: 437

C 14439 Pamela Culig Vol#: 437

C 14440 Marguerite Sheridan Vol#: 437

C 14441 Adele Morse Vol#: 437

C 14442 Nancy H. Moubray Vol#: 437

C 14443 Evelyn Levenson Vol#: 437

C 14444 Anne Beaumont Vol#: 437

C 14445 Mrs. Leanne Overlander Vol#: 437

C 14446 Shirley Hintz Vol#: 437

C 14447 Stephen & Carolyn Bender Vol#: 437

C 14448 Donald Smith Vol#: 437

C 14449 Vicki Kirsch Vol#: 437

C 14450 Art Judd Vol#: 437

C 14451 Susan Hotham Vol#: 437

C 14452 Ann Dasburg Vol#: 437

C 14453 Sue C. Bockmon Vol#: 437

C 14454 Sylvia Bonilla Vol#: 437

C 14455 Roc Economoc Vol#: 437

C 14456 Carol Rowland Vol#: 437

C 14457 Mrs. David Hobson Vol#: 437

C 14458 Joan Connor Vol#: 437

C 14459 Monica Hetebrink Vol#: 437

C 14460 Evelyn H. Hamm Vol#: 437

C 14461 Darcy Cohn Vol#: 437

C 14462 K. A. Bruno Vol#: 437

C 14463 Michael Dirks Vol#: 437

C 14464 Theresa Oppeh Vol#: 437

C 14465 Frank & Marilyn Rega Vol#: 437

C 14466 Elaine Grant Vol#: 437

C 14467 Sarah J. North-Andrews Vol#: 437

C 14468 David Uhl Vol#: 437

C 14469 Lyn Startzman Vol#: 437

C 14470 Christiane Williams Vol#: 437

C 14471 Mabel W. Colson Vol#: 437

C 14472 Paul Gershowitz Vol#: 438

C 14473 Judith Maglione Vol#: 438

C 14474 Amy Spang Vol#: 438

C 14475 Debra Thomas Vol#: 438

C 14476 Carol M. Lane Vol#: 438

C 14477 Gloria Buffington Vol#: 438

C 14478 National Coalation To Stop Acid In Food Vol#: 438

C 14479 Mrs. Eugenia Canterbury Vol#: 438

C 14480 Charles Benton Donegia Vol#: 438

C 14481 Judith L. Lavallee Vol#: 438

C 14482 Cary L. Hogan Vol#: 438

C 14483 Harry Thomsen Vol#: 438

C 14484 John W. Andreoli Vol#: 438

C 14485 Sara Vail Vol#: 438

C 14486 Jennifer Lynn Combs Vol#: 438

EMC 2998 Pamela Wunder Myers Vol#: 437

EMC 2999 Lisa R. Nastasi Vol#: 437

EMC 3000 Heidi Stukkie Vol#: 437

EMC 3001 Linda Novenski Vol#: 437

EMC 3002 Alice Aarmen Vol#: 437

EMC 3003 Kelly Depin Vol#: 437

EMC 3004 R. Mass Vol#: 437

EMC 3005 Lorraine Rodriguez Vol#: 437

EMC 3006 Teresa Vol#: 437

EMC 3007 Robert Gordon Vol#: 437

EMC 3008 Diane Pagen Vol#: 437

EMC 3009 Dave Palucci Vol#: 437

EMC 3010 David Doying Vol#: 438

EMC 3011 Yvette Rousseau Vol#: 438

EMC 3012 Cynthia Pietras Vol#: 438
 
 

00D-1274 FDA Modernization Act of 1997: Section 216

GDL 1 Guildline Vol#: 1

NAD 1 HFZ-215 Vol#: 1

00D-1307 Parathyroid Hormone/Prevention & Treatment of Osteoporosis

C 2 Eli Lilly & Co (Lilly) Vol#: 1

00D-1309 Channels trade policy commodities with methyl parathion

C 5 Apple Processors Assoc Vol#: 1

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

C 2 Center for Organ Recovery & Education Vol#: 1
 
 

00D-1407 Safety Pharmacology Studies for Human Pharmaceuticals

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1
 
 

00D-1408 Clinical Evaluation of New Antihypertensive Drugs

GDL 1 Guildline Vol#: 1

NAD 1 HFD-210 & HFM-40 Vol#: 1
 
 

00N-1256 Over-the-Counter Drug Products;Public Hearing

CH 233 Form Letters 15 Vol#: 15

CH 234 Mr & Mrs Bert Andry Vol#: 13

CH 235 Rita Knorr Vol#: 13
 
 

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

C 4 Parkview Hospital Vol#: 1

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

C 17 Alantic Orthopaedic Specialists Vol#: 1

C 18 Spine Care Institute Vol#: 1

C 19 New York University School of Medicine Vol#: 1

C 20 Form letter count 6 Vol#: 2
 
 

00N-1425 Human Tissue Intended for Transplantation

N 1 Vol#: 1

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

C 3965 Willow C. Simmons Vol#: 148

C 3966 Lori Larson Vol#: 148

C 3967 Karin E. Sjowall Vol#: 148

C 3968 Mary Fran Sarto Vol#: 148

C 3969 Heidi Wade Vol#: 148

C 3970 Sara Procknow Vol#: 148

C 3971 Tom Webb Vol#: 148

C 3972 Eleanor Kennedy Vol#: 148

C 3973 Theresa Strepek Vol#: 148

C 3974 Marvin Gordon Vol#: 148

C 3975 Marie Secinaro Vol#: 148

C 3976 Mary Ellen Frank Vol#: 148

C 3977 Christina Bowman Vol#: 148

C 3978 Amy Scott Vol#: 148

C 3979 Kitty Epperly Vol#: 148

C 3980 Ireta Copen Vol#: 148

C 3981 Pat Mick Vol#: 148

C 3982 Jennifer Druckman Vol#: 148

C 3983 Chris Anderlik Vol#: 148

C 3984 Alan & Paula Greene Vol#: 148

C 3985 Darin & Celeste Peterson Vol#: 148

C 3986 Nell Angelo Vol#: 148

C 3987 Karen Lidinsky Vol#: 148

C 3988 Leeza Monge Vol#: 148

C 3989 Lindy Christenson Vol#: 148

C 3990 Gary Harrold Vol#: 148

C 3991 Julie Weber Vol#: 148

C 3992 Mary Parken Vol#: 148

C 3993 Elizabeth Duroe Vol#: 148

C 3994 Jan Keith Vol#: 148

C 3995 Kerry Grimm Vol#: 148

C 3996 Anne Armitage Vol#: 148

C 3997 Jean Bennett Vol#: 148

C 3998 Ann Marie Fischer Vol#: 148

C 3999 Georgia E. Beeler Vol#: 148

C 4000 Lora Lytle Vol#: 148

C 4001 Mary Ann Kirsling Vol#: 148

C 4002 Rebecca Poole Vol#: 148

C 4003 Maura Powers Vol#: 148

C 4004 Rheylhdl Paris Vol#: 148

C 4005 Jesscia Crosson Vol#: 149

C 4006 Randy & Cheryl Schmucker Vol#: 149

C 4007 Deolinda Rhoads Vol#: 149

C 4008 Virginia M. Ford Vol#: 149

C 4009 Theo Jackson Vol#: 149

C 4010 Batya Kagan Vol#: 149

C 4011 B. W. Thompson Vol#: 149

C 4012 Elizabeth Hipp Vol#: 149

C 4013 Catherine Gallo Vol#: 149

C 4014 Tark Waller Vol#: 149

C 4015 Eric Shurtloff Vol#: 149

C 4016 Mary Marcos Vol#: 149

C 4017 Pamela C. Johnson Vol#: 149

C 4018 Angela M. Jaster Vol#: 149

C 4019 Wendy Krupnick Vol#: 149

C 4020 Lolina Alvarez Vol#: 149

C 4021 Michael A. Dawn Vol#: 149

C 4022 J. B. Holm Vol#: 149

C 4023 Betsey Oberg Vol#: 149

C 4024 Marliese Franklin Vol#: 149

C 4025 Esther Kronenberg Vol#: 149

C 4026 Nicole Y. Amoresano Vol#: 149

C 4027 Jeri J. Lowrey Vol#: 149

C 4028 Jodi Mann Vol#: 149

C 4029 Sharon Winnett Vol#: 149

C 4030 Frank Lieser Hill Vol#: 149

C 4031 Barbara S. Dale Vol#: 149

C 4032 Becky Amble Vol#: 149

C 4033 Michelle Delon Vol#: 149

C 4034 Jeffrey M. Dickemann Vol#: 149

C 4035 Maude Nelsen Vol#: 149

C 4036 Acarya Monge Vol#: 149

C 4037 Diane Kennedy Vol#: 149

C 4038 Marianna Padilla Vol#: 149

C 4039 Roberta Conrad Vol#: 149

C 4040 Tom Arney Vol#: 149

C 4041 Vivienne Verdon-Roe Vol#: 149

C 4042 Daniel J. Devlin Vol#: 149

C 4043 Anda Ercum Vol#: 149

C 4044 Jennifer Rempel Vol#: 149

C 4045 Paula James Vol#: 149

C 4046 Elizabeth Israel Jones Vol#: 149

C 4047 Mike Moon Vol#: 149

C 4048 Gloria A. Krueger Vol#: 149

C 4049 Cory Sanifi Vol#: 149

C 4050 Anastasia Maggi Vol#: 149

C 4051 Rosemary Clark Vol#: 149

C 4052 Rosemary Clark Vol#: 149

C 4053 Shawn Taylor Vol#: 149

C 4054 Elizabeth Holm Vol#: 149

C 4055 Beverly Raimondo Vol#: 149

C 4056 Janet H. Morrow Vol#: 149

C 4057 Diane R. Moody Vol#: 149

C 4058 Chellis Glendinning Vol#: 149

C 4059 Katherine Roberts Vol#: 149

C 4060 Jutta Gassner-Snyder Vol#: 149

C 4061 Mollie Givan Vol#: 149

C 4062 Jim Minick Vol#: 149

C 4063 Caldania Johrmarkt Vol#: 149

C 4064 Lucretia L. Saint-Jacques Vol#: 149

C 4065 Alicia Da-Silva Vol#: 149

C 4066 Ingrid Ghilarducci Vol#: 149

C 4067 Louise Quigley Vol#: 149

C 4068 Marjorie L. Davidson Vol#: 149

C 4069 Darlene B. Hapka Vol#: 149

C 4070 Pamela Wood Vol#: 149

C 4071 Jamie Amsbaugh Vol#: 149

C 4072 Grace R. Kidder Vol#: 149

C 4073 Charles Muller Vol#: 149

C 4074 Gustin Prudne Vol#: 149

C 4075 Phillip Goff & Liza Halley Vol#: 149

C 4076 Sister Marilyn Sufka Vol#: 149

C 4077 Loren J. Newkirk Vol#: 149

C 4078 Kay Thode Vol#: 149

C 4079 Suzanne L. Krzeminski Vol#: 149

C 4080 Janet Harrison Vol#: 149

C 4081 Lorinda Round Vol#: 149

C 4082 Clara Evans Vol#: 149

C 4083 Mae Woo Vol#: 149

C 4084 Sharon Rothman Vol#: 149

C 4085 A. M. Ramirez Vol#: 149

C 4086 G. Gallab Vol#: 149

C 4087 Jeff Grappo Vol#: 149

C 4088 Suella Domres Vol#: 149

C 4089 Charles Mattoon Vol#: 149

C 4090 Joan Brooking Vol#: 149

C 4091 Barbara Veldbugas Vol#: 149

C 4092 Mileva Borich Vol#: 149

00V-1405 Telemetry transmitter cable

VRA 1 HFZ-001 to Margaret A Bench RN Vol#: 1
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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