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 31, 2000

TABLE OF CONTENTS

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76N-052N OTC Nasal Decongestants *
78N-0038 Sunscreen Drug Products *
81N-0022 OTC Weight Control Drug Products for Human Use *
93N-0372 Medical Devices; Hearing Aid Requirements *
97P-0078 Recognized the Term "Soymilk" as the Established Common of U *
97P-0498 Label foods & beverages containing greater than 5mg caffeine *
00D-1307 Parathyroid Hormone/Prevention & Treatment of Osteoporosis *
00P-0685 Revise of Yogurt Standards *
00P-1085 Classify cranial helment in class I,exempt from premarket *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1594 ANADA for Invermectin *

76N-052N OTC Nasal Decongestants

EMC 3 Thomas N Tiedt PhD Vol#: 73


78N-0038 Sunscreen Drug Products

C 587 Schering-Plough Corp Vol#: 145


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

EMC 1 Thomas N Tiedt PhD Vol#: 95

92F-0305 Polydextrose as a bulking agent/texturizer in tablespreads

BKG 1 BACKGROUND MATERIAL Vol#: 1

NFR 1 Vol#: 1

93N-0372 Medical Devices; Hearing Aid Requirements

C 4681 Michael Smith Vol#: 87

C 4682 David Lucas Vol#: 87

C 4683 Debbie Helmholt Vol#: 87

C 4684 Mark A. Shanta Vol#: 87

C 4685 Triplet Hearing Centers Vol#: 87

C 4686 Miracle Ear Vol#: 87

C 4687 Miracle Ear Vol#: 87

C 4688 Killean Hearing Aid Center Vol#: 87

C 4689 Jonesboro Hearing Aid Service Vol#: 87

C 4690 Jennifer Ross Rodgers Vol#: 87

C 4691 Bruce E. Mow Vol#: 87

C 4692 Merced Hearing Aid Center Vol#: 87

C 4693 Miracle-Ear Vol#: 87

C 4694 Merced Hearing Aid Center Vol#: 87

C 4695 William C. Morgan Vol#: 87

C 4696 Ambrose Dreiling Vol#: 87

C 4697 Americare Hearing Aid Center, Inc. Vol#: 87

C 4698 The Hearing Aid Center Vol#: 87

C 4699 The Hearing Aid Center Vol#: 87

C 4700 Robert Wilson Vol#: 87

C 4701 Kent J. Davenport Vol#: 87

C 4702 Snyder Hearing, Inc. Vol#: 87

C 4703 James H. Yuhas Vol#: 88

C 4704 Graham Hearing Services, Inc. Vol#: 88

C 4705 Michael's Hearing Care Vol#: 88

C 4706 Michael's Hearing Care Vol#: 88

C 4707 Miracle Ear Vol#: 88

C 4708 Paul J. Dietsch Vol#: 88

C 4709 Jo Anne Stokfisz Vol#: 88

C 4710 Randall G. Barden Vol#: 88

C 4711 A Hearing Service, Inc. Vol#: 88

C 4712 A Hearing Service, Inc. Vol#: 88

C 4713 Quality Hearing Systems Vol#: 88

C 4714 New Jersey Medical School (UMD) Vol#: 88

C 4715 Sears Hearing Aid Center Vol#: 88

C 4716 John E. Thom Vol#: 88

C 4717 Mid America Hearing Center Vol#: 88

C 4718 Transistor Hearing Aid Co., Inc. Vol#: 88

C 4719 Mission Hearing Aid Center Vol#: 88

C 4720 Hearing Aid Institute, Inc. Vol#: 88

C 4721 Grand Island Hearing Aid Center, Inc. Vol#: 88

C 4722 Grand Island Hearing Aid Center, Inc. Vol#: 88

C 4723 Beltone Hearing Care Center Vol#: 88

C 4724 Beltone Hearing Care Center Vol#: 88

C 4725 Avada Hearing Care Centers of Arizonia Vol#: 88

C 4726 Monroe Hearing Aid Service, Inc. Vol#: 88

C 4727 Hearing Aid Institute, Inc. Vol#: 88

C 4728 Monroe Hearing Aid Service, Inc. Vol#: 88

C 4729 Sherrene Hubbard Vol#: 88

C 4730 Specialized Hearing Instruments, Inc. Vol#: 88

C 4731 Family Hearing Center Vol#: 88

C 4732 Beltone Hearing Aid Center Vol#: 88

C 4733 Professional Hearing Health Centers Vol#: 88

C 4734 Duane L. Johnson Vol#: 88

C 4735 Advanced Instruments Vol#: 88

C 4736 Pueblo Hearing Aid Center, Inc. Vol#: 88

C 4737 Richardson Quality Hearing Aid Center Vol#: 88

C 4738 Miracle Ear Center Vol#: 88

C 4739 Miracle Ear Center Vol#: 88

C 4740 Audiophone Company Vol#: 88

C 4741 Ear Labs Hearing Vol#: 88

C 4742 Miracle Ear Hearing Systems Vol#: 88

C 4743 Sears Hearing Aid Center Vol#: 88

C 4744 Andrea Lynne Stein Vol#: 88

C 4745 Miracle Ear Vol#: 88

C 4746 Michael Buitekant Vol#: 88

C 4747 Illegible Vol#: 88

C 4748 Quality Choice Hearing Aid Center Vol#: 91

C 4749 Audio Professional Vol#: 91

C 4750 Beltone Hearing Aid Center Vol#: 91

C 4751 Garden State Hearing Aid Centers Vol#: 91

C 4752 Chico Hearing Aid Center Vol#: 91

C 4753 Chico Hearing Aid Center Vol#: 91

C 4754 Advanced Hearing Systems, Inc. Vol#: 91

C 4755 Hearing Healthcare Centers, Inc. Vol#: 91

C 4756 Hearing Healthcare Centers, Inc. Vol#: 91

C 4757 Hearing Healthcare Centers, Inc. Vol#: 91

C 4758 Hearing Healthcare Centers, Inc. Vol#: 91

C 4759 Miracle-Ear Hearing Systems Vol#: 91

C 4760 Miracle-Ear Hearing Systems Vol#: 91

C 4761 Miracle-Ear Hearing Systems Vol#: 91

C 4762 Miracle-Ear Hearing Systems Vol#: 91

C 4763 Hopmeier Hearing Centers Vol#: 91

C 4764 Hopmeier Hearing Centers Vol#: 91

C 4765 Hopmeier Hearing Centers Vol#: 91

C 4766 Beltone Vol#: 91

C 4767 Beltone Vol#: 91

C 4768 Hearing Aid Counselors, Inc. Vol#: 91

C 4769 Hearing Aid Counselors, Inc. Vol#: 91

C 4770 Avada Hearing Care Centers of Arizonia Vol#: 91

C 4771 Hearing Systems, Inc. Vol#: 91

C 4772 Hearing Systems, Inc. Vol#: 91

C 4773 Audioear Hearing Aid Centers, Inc. Vol#: 91

C 4774 Miracle Ear Hearing Systems Vol#: 91

C 4775 Miracle Ear Hearing Systems Vol#: 91

C 4776 Miracle Ear Hearing Systems Vol#: 91

C 4777 Miracle Ear Hearing Systems Vol#: 91

C 4778 Robin Hutson Vol#: 91

C 4779 Patrick Leedy Vol#: 91

C 4780 Frank Robert Glatz Vol#: 91

C 4781 Ruth Ellen Eddy Vol#: 91

C 4782 Barbara A. Rhoades Vol#: 91

C 4783 Better Hearing Aid Center Vol#: 91

C 4784 Modesto Hearing Aid Center Vol#: 91

C 4785 Modesto Hearing Aid Center Vol#: 91

C 4786 Wilson's Hearing Aid Center Vol#: 91

C 4787 Wesson Optical Inc. Hearing Aid Center Vol#: 91

C 4788 Beltone Hearing Care Center Vol#: 91

C 4789 Beltone Hearing Care Center Vol#: 91

C 4790 North-Central Indiana Centers Vol#: 91

C 4791 Miracle Ear Hearing Systems Vol#: 91

C 4792 Advanced Instruments Vol#: 91

C 4793 All Ears Hearing Aid Center Vol#: 91

C 4794 Dr. Russell Perry Vol#: 91

C 4795 Orange County Professional Hearing & Spe Vol#: 91

C 4796 Hearing Aid Consultants Vol#: 91

C 4797 Belton Hearing Aid Center Vol#: 91

C 4798 Belton Hearing Aid Center Vol#: 91

C 4799 Belton Hearing Aid Center Vol#: 91

C 4800 Belton Hearing Aid Center Vol#: 91

C 4801 Belton Hearing Aid Center Vol#: 91

C 4802 Belton Hearing Aid Center Vol#: 91

C 4803 Belton Hearing Aid Center Vol#: 91

C 4804 Form letter count 41 Vol#: 103

C 4805 Form letter count 71 Vol#: 104

C 4806 Form letter count 18 Vol#: 105

C 4807 Form letter count 29 Vol#: 106

EMC 2 Cameron A. Gillespie Vol#: 91

94N-0380 Gastroenterology-Urology Devices; Implanted Hydralic Device

NCR 1 Vol#: 2

97P-0078 Recognized the Term "Soymilk" as the Established Common of U

C 141 Mr & Mrs Mettler Vol#: 1

C 142 Christine Morrissey Vol#: 1

C 143 Peter & Barbara Stasz+Sharon Stasz Vol#: 1

EMC 3 Kristine Sparks Vol#: 1


97P-0498 Label foods & beverages containing greater than 5mg caffeine

EMC 1 CPI Vol#: 1

99N-1852 Status reports/postmarketing studies-human drugs&biological

NFR 1 Vol#: 1

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

C 12 Kenneth D Burman MD Vol#: 1

00N-1200 Dietary Supplements Containing Ephedrine Alkaloids

C 37 Christopher E Grell Vol#: 68

EMC 18 Thomas N Tiedt PhD Vol#: 68

00N-1364 Prescription Drug User Fee Act (PDUFA) Public Meeting

C 4 Public Citizen's Health Research Group Vol#: 3

00N-1426 Emergency Health Surveys;Agency Information Collection Acti

N 2 Vol#: 1

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

NPH 1 Vol#: 1

00P-0685 Revise of Yogurt Standards

C 1 Sue Kelly (CI) Vol#: 1

C 2 Dave Camp (CI) Vol#: 1

C 3 Jack Quinn (CI) Vol#: 1

C 4 John Boehner (CI) Vol#: 1

C 5 Juanita Millender-McDonald (CI) Vol#: 1


00P-1085 Classify cranial helment in class I,exempt from premarket

PAV 1 HFS-206 TO C Michael Schuch Vol#: 1


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

C 7131 Christopher Ann Vol#: 303

C 7132 Grant Sawyer Vol#: 303

C 7133 Mordee Dourardish Vol#: 303

C 7134 Kenny W Rogers Vol#: 303

C 7135 Maetra L Doorandish Vol#: 303

C 7136 Unsigned Vol#: 303

C 7137 Lucy Gregory Vol#: 303

C 7138 Ruth Surgarl Vol#: 303

C 7139 Dean Luurtsema Vol#: 303

C 7140 M Riches Vol#: 303

C 7141 Cindy Thompson Vol#: 303

C 7142 Nancy Hansen-Bennett Vol#: 303

C 7143 Faith Zobel Vol#: 303

C 7144 Jenny Eubank Vol#: 303

C 7145 Lois Farrins Vol#: 303

C 7146 Myrtle Foster Vol#: 303

C 7147 Leona J Chadwick Vol#: 303

C 7148 Beryl Ganzer Vol#: 303

C 7149 Cathryn P Luse Vol#: 303

C 7150 Beryl Petersen Vol#: 303

C 7151 Ethel Parise Vol#: 303

C 7152 Verna Lambrecht Vol#: 303

C 7153 Lucy Silvester Vol#: 303

C 7154 A M Wilson Vol#: 303

C 7155 Shirley Carpenter Vol#: 303

C 7156 Arline Randolpher Vol#: 303

C 7157 Judy Luing Vol#: 303

C 7158 Judith Vasby Vol#: 303

C 7159 Cynthia Grosskreutz Vol#: 303

C 7160 Carrine Robson Vol#: 303

C 7161 Sara Roquemore Vol#: 303

C 7162 Lorna Rinck Vol#: 303

C 7163 Lucille Mentzel Vol#: 303

C 7164 Billie LaBumbard Vol#: 303

C 7165 Joan Bentley Vol#: 303

C 7166 Linda Weber Vol#: 303

C 7167 Audrey Rohde Vol#: 303

C 7168 Frank Kuhlman Vol#: 303

C 7169 Sandra Challoner Vol#: 303

C 7170 Salud Rodeman Vol#: 303

C 7171 Joann Tures Vol#: 303

C 7172 Joan Link Vol#: 303

C 7173 Dona Siepert Vol#: 303

C 7174 Inez Gulbrandson Vol#: 303

C 7175 Alma C Grace Vol#: 303

C 7176 Betty Merington Vol#: 303

C 7177 Imgeborg Wolferstetter Vol#: 303

C 7178 Jean Kroeplin Vol#: 303

C 7179 Evelyn Baerbock Vol#: 303

C 7180 Pauline I Scott Vol#: 303

C 7181 Loina Saffran Vol#: 303

C 7182 Cathy Baker Vol#: 303

C 7183 Elizabeth Ingersoll Vol#: 303

C 7184 Germaine Wandrey Vol#: 303

C 7185 Joyce Scadden Vol#: 303

C 7186 Nancy Luedcke Vol#: 303

C 7187 C Wintermate Vol#: 303

C 7188 Margaret Wogaman Vol#: 303

C 7189 Lucinda L Heal Vol#: 303

C 7190 Hulda M Melvin Vol#: 303

C 7191 Rose M NElson Vol#: 303

C 7192 Audrey Koukari Vol#: 303

C 7193 Amber Nelson Vol#: 303


00P-1594 ANADA for Invermectin

ACK 1 HFA-305 Vol#: 1

CP 1 Highland Vet-Pharma, LLC Vol#: 1
 

00Q-1582 Notification for Health Claims:Potassium Containing Foods

ACK 1 HFS-832 to Tropicana Products Inc Vol#: 1

HCN 1 Tropicana Products Inc. Vol#: 1

LET 1 HFS-832 to Institute of Medicine Vol#: 1

LET 2 HFS-832 to Tropicana Products Inc Vol#: 1

SUP 1 Tropicana Products Inc Vol#: 1

SUP 2 Tropicana Products Inc Vol#: 1

SUP 3 Tropicana Products Inc Vol#: 1

SUP 4 Tropicana Products Inc Vol#: 1

SUP 5 Tropicana Products Inc Vol#: 1

SUP 6 Tropicana Products Inc Vol#: 1