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 30, 2000

TABLE OF CONTENTS

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78N-036L OTC Laxative *
92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992 *
93N-0372 Medical Devices; Hearing Aid Requirements *
95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient *
97P-0329 Require Quantitative Labeling of Caffeine Content *
98P-0151 Introduction Of Downed Cattle Into The Food Supply
98P-0509 Refrain from Destroying Dietary Supp. Co Publications *
00D-1385 Investigational Device Exemption (IDE's) & (PMA) *
00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair *
00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1535 Biopsy forceps covers/non-electric biopsy as Class I devices *
78N-036L OTC Laxative

C 204 CHPA Vol#: 107

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

LST 1 Agenda for 10/27/00 FDA Part 15 Hearing Vol#: 6

TS 1 Pharmaceutical Distributors Association Vol#: 6

TS 2 American Veterinary Distributors Assoc Vol#: 6

TS 3 Public Citizen's Health Research Group Vol#: 6

TS 4 America's Blood Centers Vol#: 6

TS 5 PhRMA Vol#: 6

93N-0372 Medical Devices; Hearing Aid Requirements

C 4652 Miracle Ear Vol#: 87

C 4653 Miracle Ear Vol#: 87

C 4654 Miracle Ear Vol#: 87

C 4655 Miracle Ear Vol#: 87

C 4656 Miracle Ear Vol#: 87

C 4657 Hearing Aid Center Vol#: 87

C 4658 Alexandria Hearing Aid Center Vol#: 87

C 4659 Miracle Ear Vol#: 87

C 4660 Miracle Ear Vol#: 87

C 4661 Miracle Ear Vol#: 87

C 4662 Miracle Ear Vol#: 87

C 4663 Quality Hearing Systems Vol#: 87

C 4664 Hear in Kentucky Vol#: 87

C 4665 Central Pennsylvania Eye & Ear Vol#: 87

C 4666 Sutter Hearing Aid Center Vol#: 87

C 4667 Beltone Hearing Aid Center Vol#: 87

C 4668 Miracle Ear Center Vol#: 87

C 4669 American Academy of Audiology Vol#: 87

C 4670 Miracle Ear Vol#: 87

C 4671 Georgean A. Barden Vol#: 87

C 4672 Tobias Battite Inc. Hearing Healthcare Vol#: 87

C 4673 Littlefield's Hearing Aids Vol#: 87

C 4674 Littlefield's Hearing Aids Vol#: 87

C 4675 Gary F. Welch Vol#: 87

C 4676 James L. Van Hoose Vol#: 87

C 4677 Glassman's Hearing Aid Service Vol#: 87

C 4678 Stephen P. Thomas Vol#: 87

C 4679 Center For Better Hearing Aids Vol#: 87

C 4680 Pennyrile Hearing Aid Center Vol#: 87

EMC 1 Phyllis S. Weller Vol#: 87

95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient

C 318 Rose Holt Vol#: 7

97P-0329 Require Quantitative Labeling of Caffeine Content

C 239 Rita M Fox Vol#: 4

98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding

C 173 Robert J Warren Vol#: 21
 

98P-0151 Introduction Of Downed Cattle Into The Food Supply

C 2387 Form letter count 19 Vol#: 70

C 2388 Kristy Boettler Vol#: 72

C 2389 Frank's Maintenance & Engineering, Inc. Vol#: 72

C 2390 Muriel McComiskey Vol#: 72

C 2391 Ms. Jamey Lee West Vol#: 72

C 2392 Florence-Peter Passalacqua Vol#: 72

C 2393 Cathy Ridenbaugh Vol#: 72

C 2394 Linda Johnsen Vol#: 72

C 2395 Bernice R. Bowman Vol#: 72

C 2396 Donald A. Trump Vol#: 72

C 2397 James P. Conway Vol#: 72

C 2398 Sylvia M. Lana Vol#: 72

C 2399 Beth Bantz & Edward Boulter Vol#: 72

C 2400 Madeline Day Vol#: 72

C 2401 Patricia Robison Vol#: 72

C 2402 Karen Faxon Vol#: 72

C 2403 Jean Lauren Vol#: 72

C 2404 Lila Lahalih Vol#: 72

C 2405 Fran C. Storer Vol#: 72

C 2406 Diana Morton Vol#: 72

C 2407 Miranda Grizio Vol#: 72

EMC 139 Form letter count 29 Vol#: 69

EMC 140 Form letter count 32 Vol#: 71

98P-0509 Refrain from Destroying Dietary Supp. Co Publications

C 334 Ruth Logerquist Vol#: 5

99P-2630 Establish a Daily Value for "added sugars"

C 534 John Saemann Vol#: 26

C 535 Mary Lou Zoltowski Vol#: 26

C 536 Mary Lou Kinner Vol#: 26

C 537 Jenny Salcido Vol#: 26

C 538 V. Rose Vol#: 26

C 539 Maxine Beattie Vol#: 26

C 540 Childrens Hospital Los Angeles Vol#: 26

C 541 Caroline S. Smith Vol#: 26

C 542 Barbara Purcell Vol#: 26

C 543 Carolyn Hestand Vol#: 26

C 544 Pruett A. Kelly Vol#: 26

C 545 Lyle Black Vol#: 26

C 546 Marianne Whiting Vol#: 26

C 547 Pamela J. Bourgoine Vol#: 26

C 548 Patricia Rowe Vol#: 26

C 549 Chippewa County Dept. of Public Health Vol#: 26

C 550 Mary Rose Hayes Vol#: 26

C 551 Clara Collins Vol#: 26

C 552 Elizabeth Leonie Simpson Vol#: 26

C 553 Nazanin Amjadi Vol#: 26

C 554 Ilsemarie Caspar Vol#: 26

C 555 Jason Duncan Vol#: 26

C 556 Beverly Hilleary Vol#: 26

C 557 Denis Cagna Vol#: 26

C 558 Pearlie Llewellyn Vol#: 26

C 559 Joan Craco Vol#: 26

C 560 Ardis J. Browne Vol#: 26

C 561 Ella J. Mueller Vol#: 26

C 562 Betty C. Selfridge Vol#: 26

C 563 Maureen Barber Vol#: 26

C 564 B. Gascoignes Vol#: 26

C 565 Emmy Zumwalt Vol#: 26

EMC 380 Lisa J. Berlin Vol#: 26

EMC 381 Diane Goldner Vol#: 26

EMC 382 John Mini Vol#: 26

EMC 383 Caroline Pincus Vol#: 26

EMC 384 Louisa Ruffine Vol#: 26

EMC 385 Eric Rubin Vol#: 26

EMC 386 Jenifer Steig Vol#: 26

EMC 387 Elyse Post Vol#: 26

EMC 388 Jonel Larson Vol#: 26

EMC 389 Nicole Ruffine Vol#: 26

EMC 390 Janet Rankin Vol#: 26

EMC 391 Norman Oder Vol#: 26

EMC 392 Lea Byrd Vol#: 26

EMC 393 Kim Stahlman Kearns Vol#: 26

EMC 394 Eileen Daly Vol#: 26

EMC 395 Brooke Guge Haynes Vol#: 26

EMC 396 Don M. Cole Vol#: 26

EMC 397 Instituto de Estudios del Azucar y la Vol#: 26

EMC 398 dgigi j Vol#: 26

EMC 399 Felecity Hanson Vol#: 26

EMC 400 Vetrovl Vol#: 26

EMC 401 Tony Oceanside Vol#: 26

EMC 402 Terry & Ray Lambeth Vol#: 26

EMC 403 John Punton Vol#: 26

EMC 404 Mark Lochbaum Vol#: 26

EMC 405 Carla Zuckerman Vol#: 26

EMC 406 Tom Urtz Vol#: 26

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

C 2 Allergan Surgical Vol#: 1

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

C 3 Aventis Pharmaceuticals Vol#: 1

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

C 30 King & Spalding Vol#: 2

00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop

C 23 Advanced Medical Technology Association Vol#: 1

C 24 Sharlane Donaldson Vol#: 1

C 25 American Academy of Family Physicians Vol#: 1

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

C 7011 Elaine A Gordon Vol#: 302

C 7012 Lila Fleck Vol#: 302

C 7013 Howard & Gwen Wiederrich Vol#: 302

C 7014 Wanda Buchanan Vol#: 302

C 7015 Davene Mechan Vol#: 302

C 7016 Cherie Basy Vol#: 302

C 7017 Irma K Paule Vol#: 302

C 7018 Janet Hoffman Vol#: 302

C 7019 Terri Mitchell Vol#: 302

C 7020 Chris Sanders Vol#: 302

C 7021 Jeanette D'Amico Vol#: 302

C 7022 John Schmidt Vol#: 302

C 7023 Meribeth L Howlett Vol#: 302

C 7024 Elsa Douglas Vol#: 302

C 7025 Peter McDowell Vol#: 302

C 7026 Gloria McDowell Vol#: 302

C 7027 Angela Walker Vol#: 302

C 7028 Helen Hutchison Vol#: 302

C 7029 Joseph Hutchison Vol#: 302

C 7030 Elizabeth Gates Vol#: 302

C 7031 Leslie Ann Nevaux Vol#: 302

C 7032 Nisbufe Vol#: 302

C 7033 Deborah Bueno Vol#: 302

C 7034 S White Vol#: 302

C 7035 Mr & Mrs John Baxter Vol#: 302

C 7036 Siri C Skar Vol#: 302

C 7037 Joe Maxiuetz Vol#: 302

C 7038 Kathy Malek Vol#: 302

C 7039 Jean Foth Vol#: 302

C 7040 Rachel Ficardi Vol#: 302

C 7041 Kathryn D Garcia Vol#: 302

C 7042 LuAnn McKenzie Vol#: 302

C 7043 Heather Clark Vol#: 302

C 7044 Karann Durland Vol#: 302

C 7045 Jacoba Gold Vol#: 302

C 7046 Iris Tansmer Vol#: 302

C 7047 Mark E Mintz Vol#: 302

C 7048 J L Bowne Vol#: 302

C 7049 Ben Raynor Vol#: 302

C 7050 Monica Snyder Vol#: 302

C 7051 Judith Fitch Vol#: 302

C 7052 Norma Sandler Vol#: 302

C 7053 Cyrene Marciano Vol#: 302

C 7054 Melissa Oliver Montgomery Vol#: 302

C 7055 Julie Sievert Vol#: 302

C 7056 Anne Munitz Vol#: 302

C 7057 Kathy Whalen Vol#: 302

C 7058 B Cesmat Vol#: 302

C 7059 Jean Des Biens Vol#: 302

C 7060 Peter W Wilson Vol#: 302

C 7061 E M Bonjorno Vol#: 302

C 7062 Karen Loche Vol#: 302

C 7063 Larince Tayler Vol#: 302

C 7064 Kristin Killops Vol#: 302

C 7065 Tess Hoke Vol#: 302

C 7066 Susan Leird Vol#: 302

C 7067 Judith Baranowski Vol#: 302

C 7068 Julie Falen Vol#: 302

C 7069 Urike Anderson Vol#: 302

C 7070 Wendi Raw Vol#: 302

C 7071 Sharico Law Vol#: 302

C 7072 Eve Shapiro Vol#: 302

C 7073 T J Armour Vol#: 302

C 7074 Margaret M Mason Vol#: 302

C 7075 Joyce Chapp Vol#: 302

C 7076 Rebecca Costello Vol#: 302

C 7077 Gina Ronzone Vol#: 302

C 7078 Dallas Starwalt Vol#: 302

C 7079 Marty Owings Vol#: 302

C 7080 C Randall White Vol#: 302

C 7081 A R Aay Vol#: 302

C 7082 Nancy T Alvet Vol#: 302

C 7083 Joel A Reed Vol#: 302

C 7084 Lynn Showell Vol#: 302

C 7085 M C Thomas Vol#: 302

C 7086 David E McNeely Vol#: 302

C 7087 Megan Crawford Vol#: 302

C 7088 C Ralston Vol#: 302

C 7089 Heather Valle Torres Vol#: 302

C 7090 Rebecca J Pearson Vol#: 302

C 7091 Carol Thomas Vol#: 302

C 7092 Terri Pauls Vol#: 302

C 7093 Pat Lindsay Vol#: 302

C 7094 Joel Smith Vol#: 302

C 7095 Sabrina Norberg Vol#: 302

C 7096 Thomas R Gillis Vol#: 302

C 7097 Susie McCown Vol#: 303

C 7098 Aliana Scurlock Vol#: 303

C 7099 Peeter Alvet Vol#: 303

C 7100 Ann & Steve Davis Vol#: 303

C 7101 Mary Flickinger Vol#: 303

C 7102 Toni Sutherland Vol#: 303

C 7103 Brian Taylor Vol#: 303

C 7104 B LeEllen Greeley Vol#: 303

C 7105 Julie Gatti Vol#: 303

C 7106 Kayla Boyd Vol#: 303

C 7107 Dana DeMille Vol#: 303

C 7108 Mary Pallant Vol#: 303

C 7109 Carol S Marshall Vol#: 303

C 7110 Dorothy L Warren Vol#: 303

C 7111 Donna S Muniz Vol#: 303

C 7112 Noel Gregory Vol#: 303

C 7113 Sherri Parks Vol#: 303

C 7114 Celeste Goyer Vol#: 303

C 7115 Louise Dubin Vol#: 303

C 7116 Ellene Morris Vol#: 303

C 7117 Christine Waltermyer Vol#: 303

C 7118 Betty L. McGee Vol#: 303

C 7119 Polkowska E Vol#: 303

C 7120 Henriette Lerner Vol#: 303

C 7121 Andrew Kean Vol#: 303

C 7122 Lyn A Govette Vol#: 303

C 7123 Carol Kean Vol#: 303

C 7124 Jennifer Girard Vol#: 303

C 7125 Roland Hoyt Vol#: 303

C 7126 Harlan Cross Vol#: 303

C 7127 Chere Burdette Vol#: 303

C 7128 Mary Gertson Vol#: 303

C 7129 Lee Bunderson Vol#: 303

C 7130 Clare Tucker Vol#: 303

00P-1535 Biopsy forceps covers/non-electric biopsy as Class I devices

SUP 1 Boston Scientific Corporation Vol#: 2

00V-1327 Medi-laze Smart Laser Product

VRA 1 HFZ-340 to Adlaser Pty Ltd Vol#: 1

00V-1417 Twilite Dental Diode Laser

VRA 1 HFZ-340 Vol#: 1

00V-1588 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 T & B Productions Vol#: 1

00V-1589

ACK 1 HFA-305 Vol#: 1

VAR 1 Quickbeam Systems Inc. Vol#: 1

00V-1590

ACK 1 HFA-305 Vol#: 1

VAR 1 Sound Advice Vol#: 1