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 10/20/00
DOCKETS ENTERED on 10/21/00

TABLE OF CONTENTS

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[FDA DOCKETS PAGE] [FDA HOME PAGE]  [ ITEM CODES ]
 
DOCKETS ENTERED on 10/20/00
93N-0372 Medical Devices; Hearing Aid Requirements *
94D-0025 Interim GDL/Labeling Milk & Milk Products from Cows w/rbST *
96P-0243 Adopt Bioequivalency Requirements for Propafenone Tablets *
97P-0079 Deny Exclusivity to Nicotine Patch Sub Products for OTC Use *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99P-3029 Health Claim: Folic Acid, Vitamin B6 etc & Vascular Disease *
99P-4053 Sympathominetic Amine Phentermine *
99P-4375 Health Claim: Vitamin E and Heart Disease
00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal *
00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop *
00N-1399 Presubmission Conferences *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1322 Food Labeling and Allergen Contamination Control*
00P-1574 ANDA Suitability Petition for Potassium Lodide 65 mg Tablets *
00V-1573 Laser Display Device *

DOCKETS ENTERED on 10/21/00

 97P-0478 Safety of UVA tanning unit labeling and use *
98P-0610 Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC *
00D-1197 180-Day Exclusivity Under the Hatch-Waxman Amendments *
00D-1307 Parathyroid Hormone/Prevention & Treatment of Osteoporosis *
00D-1384 Physical Examination of Surgeons' &/or Patient Exam Gloves *

93N-0372 Medical Devices; Hearing Aid Requirements

C 4602 Miracle Ear Vol#: 86

C 4603 Miracle Ear Vol#: 86

C 4604 Miracle Ear Vol#: 86

C 4605 Miracle Ear Vol#: 86

C 4606 Miracle Ear Vol#: 86

C 4607 Alpine Hearing Aid Center Vol#: 86

C 4608 Beltone Hearing Aid Center Vol#: 86

C 4609 Miracle Ear Vol#: 86

C 4610 Hearing Pro Vol#: 86

C 4611 Hearing Care Center Vol#: 86

C 4612 Miracle Ear Vol#: 86

C 4613 Miracle Ear Vol#: 86

C 4614 Miracle Ear Vol#: 86

C 4615 Miracle Ear Vol#: 86

C 4616 Miracle Ear Vol#: 86

C 4617 Miracle Ear Vol#: 86

C 4618 David Elder Vol#: 86

C 4619 Dean R. McHatton Vol#: 86

C 4620 Robert D. Stewart Vol#: 86

C 4621 Laura J. Walls Vol#: 86

C 4622 A-1 Hearing Aid Centers Vol#: 86

C 4623 Michael's Hearing Center Vol#: 86

C 4624 Linda M. Hames Vol#: 86

C 4625 Audiology Associates of Georgia Vol#: 86

C 4626 Stone-Lang Company Vol#: 86

C 4627 Preferred Hearing Aid Center Vol#: 86

C 4628 Midwest Hearing Aids Inc. Vol#: 86

C 4629 Hearing Solutions Vol#: 86

C 4630 Beltone Hearing Aid Center Vol#: 86

C 4631 Conway Hearing Aid Center Vol#: 86

C 4632 Sandra Hobson Vol#: 86

C 4633 Sharp Hearing Systems Vol#: 86

C 4634 Avada Audiology & Hearing Care Vol#: 86

C 4635 Belton Hearing Aid of Charleston Vol#: 86

C 4636 Arcade Hearing Aid Center Vol#: 86

C 4637 The Hearing Aid Center Vol#: 86

C 4638 Sears Hearing Aid Center Vol#: 86

C 4639 The Hearing Aid Center Vol#: 86

C 4640 Anne Wischmeier Vol#: 86

C 4641 Preferred Hearing Aid Center Vol#: 86

C 4642 Altoona Hearing Aid Service Vol#: 86

C 4643 Precision Hearing Vol#: 86

C 4644 Beltone Hearing Services Vol#: 86

C 4645 Ross L. Western Vol#: 86

C 4646 Miracle Ear Vol#: 86

C 4647 Allen J. Melanco Vol#: 86

C 4648 Julie S. Cheramie Vol#: 86

C 4649 Jordan Beni Vol#: 86

C 4650 Calvin Kraemer Vol#: 86

C 4651 Bateman Hearing Aid Center Vol#: 86

94D-0025 Interim GDL/Labeling Milk & Milk Products from Cows w/rbST

C 8561 Pamela Thorne Vol#: 116

96P-0243 Adopt Bioequivalency Requirements for Propafenone Tablets

SUP 4 Knoll Pharmaceutical Company Vol#: 2

97P-0079 Deny Exclusivity to Nicotine Patch Sub Products for OTC Use

C 2 Novartis Consumer Health Inc. Vol#: 1

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

C 2326 Fran C. Storer Vol#: 67

C 2327 Doris L. Carey Vol#: 67

C 2328 Karen Ojeda Vol#: 67

C 2329 Linda L. Uling Vol#: 67

C 2330 Madeline Day Vol#: 67

C 2331 Su Zanne Vol#: 67

C 2332 Cynthia Brandes Vol#: 67

C 2333 Dave Wachsman Vol#: 67

C 2334 Jeanne Sill Vol#: 67

C 2335 Rita Leone Vol#: 67

C 2336 Mrs. Geri Tillett Vol#: 67

C 2337 Kathleen Gray, MD Vol#: 67

C 2338 Anthony Masina Vol#: 67

C 2339 Ms. Deirdre Peterson Vol#: 67

C 2340 Carole Gunn Vol#: 67

C 2341 Carl Rigotti Vol#: 67

C 2342 Ms. Sherry Moore Vol#: 67

C 2343 Bernard Caley Vol#: 67

C 2344 Dr. Joyce L. Bloom Vol#: 67

C 2345 Dorothy Ramsaier Vol#: 67

C 2346 Ann Marie L. Miller Vol#: 67

C 2347 Linda Balkanli Vol#: 67

C 2348 Diana Reese Vol#: 67

C 2349 Marian Carter Vol#: 67

C 2350 Shelby Scarbrough Vol#: 67

C 2351 Homer & Patricia Poole Vol#: 67

C 2352 Karen A. Ferraro Vol#: 67

C 2353 D. T. Dickson Vol#: 67

C 2354 Janet M. Aylward Vol#: 67

C 2355 J F Vol#: 67

C 2356 Sonja Tafel Vol#: 67

C 2357 Mike Louis Vol#: 67

C 2358 Kimberly Michaud Vol#: 67

C 2359 Diana Reese Vol#: 67

99P-3029 Health Claim: Folic Acid, Vitamin B6 etc & Vascular Disease

SUP 5 Emord & Associates, P.G. & others Vol#: 12

99P-4053 Sympathominetic Amine Phentermine

ACK 2 HFA-305 Vol#: 1

PRC 1 Mark P. Grath, Esq. Vol#: 1

99P-4375 Health Claim: Vitamin E and Heart Disease

SUP 4 Emord & Associates & others Vol#: 7

00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal

C 43 Concerned Consumer Vol#: 11

C 44 Lisa Tishler Vol#: 11

EMC 113 Bobbie Besold Vol#: 11

EMC 114 Karl Franzen Vol#: 11

EMC 115 Patriot 451 Vol#: 11

EMC 116 Concerned Consumer Vol#: 11

EMC 117 Lisa Tishler Vol#: 11

EMC 118 Cheryl Casker Vol#: 11

EMC 119 Wells Eddleman Vol#: 11

EMC 120 Linda Valentine Vol#: 11

EMC 121 Amy Stoddard Vol#: 11

EMC 122 Andrew Lindsey Vol#: 11

EMC 123 Jennifer Ehlenfeldt Vol#: 11

EMC 124 Howard Logan Vol#: 11

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

C 21 Branetta Bronson-Ross Vol#: 1

00N-1399 Presubmission Conferences

C 1 USDA Vol#: 1

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

C 6684 Virginia Waldenmaier Vol#: 307

C 6685 Terry Taylor Vol#: 307

C 6686 Laura Waters Vol#: 307

C 6687 Michelle Webb Vol#: 307

C 6688 David Moonan Vol#: 307

C 6689 Joslin Fields Vol#: 307

C 6690 Shelly Masters Vol#: 307

C 6691 Richard Lamke Vol#: 307

C 6692 Raymond Muccianti Vol#: 307

C 6693 Laura Lehner Vol#: 307

C 6694 Kelly McFadden Vol#: 307

C 6695 Don Atkins Vol#: 307

C 6696 Carol Stevenson Vol#: 307

C 6697 Sonya Anderson Vol#: 307

C 6698 John Perko Vol#: 307

C 6699 John Perko Vol#: 307

C 6700 Trina Perreault Vol#: 307

C 6701 Adriane Dellorco Vol#: 307

C 6702 Quayle Hodek Vol#: 307

C 6703 John Codiammi Vol#: 307

C 6704 Rowena Lokoen Vol#: 307

C 6705 Bette McErlean Vol#: 307

C 6706 Bethany Barry Vol#: 307

C 6707 Alex Saunders Vol#: 307

C 6708 Laura Powsner Vol#: 307

C 6709 Jessica Thurston Vol#: 307

C 6710 Sarah Lajon Vol#: 307

C 6711 Adele Reilly Vol#: 307

C 6712 K Rollins Vol#: 307

C 6713 Joan Clark Vol#: 307

C 6714 Heidi Betz Vol#: 307

C 6715 Kim Benson Vol#: 307

C 6716 Brandan Kearney Vol#: 307

C 6717 Heather Langdon Vol#: 307

C 6718 Michelle Novotny Vol#: 307

C 6719 Maria Kim-Seller Vol#: 307

C 6720 Vanessa Moore Vol#: 307

C 6721 Richard Torres-mateluna Vol#: 307

C 6722 Kathleen King Vol#: 307

C 6723 Dixie Lewellyn Vol#: 307

C 6724 Nick Rizzo Vol#: 307

C 6725 Jenna Stewart Vol#: 307

C 6726 Form Letter Count 125 Vol#: 315

00P-1322 Food Labeling and Allergen Contamination Control

C 2 The Food Allergy Network Vol#: 2

00P-1574 ANDA Suitability Petition for Potassium Lodide 65 mg Tablets

ACK 1 HFA-305 Vol#: 1

CP 1 Recip AB, c/o R & R Registrations Vol#: 1

00V-1573 Laser Display Device

ACK 1 HFA-305 Vol#: 1

VAR 1 Deja Vu of Washington Park Vol#: 1
 

DOCKETS ENTERED on 10/21/00

Docket Title

Number

97P-0478 Safety of UVA tanning unit labeling and use

PAV 1 HF-11 Vol#: 1

98P-0610 Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC

SUP 2 Blue Cross of California Pharmacy Vol#: 1

00D-1197 180-Day Exclusivity Under the Hatch-Waxman Amendments

C 7 Barr Laboratories, Inc. Vol#: 1

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

C 11 Stony Brook University Hospital Vol#: 2

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

C 1 Perusahaan Pelindung Getah (M) SDN HBD Vol#: 1

00V-1281 Laser Light Show, LM 8 Projection System

VRA 1 HFZ-330 to La Curacao Dept Store Vol#: 1

00V-1376 Laser Light Show LM-10 Projection systems/spectra physics

VRA 1 HFZ-330 to Mars 2112 Vol#: 1

00V-1377 Laser Light Show(2) LM-10 Micro Yag Projection systems

VRA 1 HFZ-330 to Mighty Ducks Hockey Club Inc Vol#: 1

00V-1421 Laser Light Show

VRA 1 HFZ-330 to Club M.K. Vol#: 1

00V-1423

VRA 1 HFZ-330 to Super Bowl Vol#: 1

00V-1430

VRA 1 HFZ-330 to Surround Design Associates Vol#: 1

00V-1438

VRA 1 HFZ-330 to Randy Johnson & Associates Vol#: 1

00V-1459

VRA 1 HFZ-330 to Burning Man Vol#: 1

00V-1461 Laser Light Show,ML10-200,ML10-300,ML10-300W,ML10-1.OG,

VRA 1 HFZ-330 to DJ Distributors Vol#: 1

00V-1469 Laser Light Show

VRA 1 HFZ-330 to ZooBar Inc. Vol#: 1

00V-1478 Laser light show

VRA 1 HFZ-330 to DJ Brat Vol#: 1

00V-1479 Laser Light Show

VRA 1 HFZ-330 to Dimension Seven Vol#: 1

00V-1480

VRA 1 HFZ-330 to Dino Quiroz Vol#: 1

00V-1492

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