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 August 16, 2000

TABLE OF CONTENTS

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75N-183H Health-Care Antiseptic Drug Products for OTC Human Use *
96N-0048 Sterility Requirements for Inhalation Solution Products *
97N-484S Human Cellular and Tissue-Based Products *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
98F-0165 safe use of ionizing radition for reduction of salmonella *
98N-0359 Program priorities/Center for Food Safety & Applied Nutritin *
99N-2497 Actions That Can be Requested by Petition; Denials, Withdraw *
00D-1277 Fumonisin Levels in Human Foods and Animal Feed *
00D-1305 Patulin in Apple Juice,Apple Juice Concentrates,Juice Produc *
00D-1307 Parathyroid Hormone/Prevention & Treatment of Osteoporosis *
00N-0504 Egg Safety Action Plan *
00N-1219 Bacterial Vaccines & Related Biological Products *
00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal *
00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair *
00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop *
00P-0653 Amend the product insert &/or label for Anthrax Vaccive adso *
00P-1227 Amend Statements Made for Dietary Supplements *
00V-1459 Laser Light Show *

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

C 58 Lonza, Inc Vol#: 60

96N-0048 Sterility Requirements for Inhalation Solution Products

C 62 Arlene D. Eley Vol#: 1

LET 1 Pascal Company, Inc Vol#: 1

LET 2 Pascal Company, Inc Vol#: 1

97N-484S Human Cellular and Tissue-Based Products

C 492 Eye Bank Association of America Vol#: 27

C 493 EBAA & AAO Vol#: 27

97S-0162 30-Day Structure Function Claim Notification Letters Dietary

C 1 Jarrow Formulas Vol#: 45

C 2 Lindberg Vol#: 45

C 3 NF Formulas, Inc. Vol#: 45

C 4 NF Formulas, Inc. Vol#: 45

C 5 NF Formulas, Inc. Vol#: 45

C 6 NF Formulas, Inc. Vol#: 45

C 7 Melaleuca, Inc. Vol#: 45

C 8 Michael's Naturopathic Programs Vol#: 45

C 9 Michael's Naturopathic Programs Vol#: 45

C 10 Michael's Naturopathic Programs Vol#: 45

C 11 Michael's Naturopathic Programs Vol#: 45

C 12 Michael's Naturopathic Programs Vol#: 45

C 13 Michael's Naturopathic Programs Vol#: 45

C 14 Michael's Naturopathic Programs Vol#: 45

C 15 Haussler Nutritionals Vol#: 45

C 16 NOW Vol#: 45
 
 

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

C 25 Animal Health Institute Vol#: 4

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

OB 9 Alix Fano Vol#: 1

OB 10 Robin Jacobson Vol#: 1

98N-0359 Program priorities/Center for Food Safety & Applied Nutritin

C 42 Richard C. Theuer, Ph.D Vol#: 1

99N-2497 Actions That Can be Requested by Petition; Denials, Withdraw

C 20 International Jelly & Preserve Assoc Vol#: 1
 
 

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

C 14556 Emily Seeton Vol#: 439

C 14557 Beth Nagel Vol#: 439

C 14558 Diana Boswell Vol#: 439

C 14559 Ginger German Vol#: 439

C 14560 Twyla Mae Olney Vol#: 439

C 14561 Mrs. Eve Wilmore Vol#: 439

C 14562 Robin Laurer Newbrey Vol#: 439

C 14563 Melissa Vannon Vol#: 439

C 14564 Eileen M. Schoen Vol#: 439

C 14565 Suzanne R. Lippuner Vol#: 439

C 14566 Freeman White Vol#: 439

C 14567 Marsi Foster Vol#: 439

C 14568 Kelly Vol#: 439

C 14569 Craig Bilow Vol#: 439

C 14570 Barbara Kay Persson Vol#: 439

C 14571 Ethelanda I. Solidum Vol#: 439

C 14572 Edward McKitta Vol#: 439

C 14573 Howard Strong Vol#: 439

C 14574 Natalie Lynn Mehrer Vol#: 439

C 14575 Duane A. Chapman Vol#: 439

C 14576 Jean S. Spencer Vol#: 439

C 14577 Ned Shun Vol#: 439

C 14578 Sara Clarkson Vol#: 439

C 14579 Tanya Bono Haro Vol#: 439

C 14580 Miranda Serh Vol#: 439

C 14581 Pamela Strong Vol#: 439

C 14582 Karla McBride Vol#: 439

C 14583 Linda Wirt Vol#: 439

C 14584 Mrs. L. E. Cole Vol#: 439

C 14585 Donna Cerasani & Matthias Muenzer Vol#: 439

C 14586 Kathleen Malone Vol#: 439

C 14587 Chaz Burton Vol#: 439

C 14588 Iris Freelander Vol#: 439

C 14589 Nontombi Naomi Tutu Vol#: 439

C 14590 V. Thomas Riley, MD Vol#: 439

C 14591 Linda Riley Vol#: 439

C 14592 Diane Dailey Cassidy Vol#: 439

C 14593 Ms. Dolores Schuhow Vol#: 439

C 14594 Don E. Johnson Vol#: 439

C 14595 Melanie Feller Vol#: 439

C 14596 Nazen Merjian Vol#: 439

C 14597 Susan & Hubert van Asch van Wyck Vol#: 439

C 14598 Rhea Worrell Vol#: 439

C 14599 Karen Balas-Cote Vol#: 439

C 14600 Mark Cote Vol#: 439

C 14601 David C. Fenimore Vol#: 439

C 14602 Catherine Nash Vol#: 439

C 14603 Nicole Amorisaro Vol#: 439

C 14604 Staci-lee Sherwood Vol#: 439

EMC 3013 James Stone Vol#: 439

EMC 3014 Leda Beth Gray Vol#: 439

EMC 3015 Mary Moran Vol#: 439

EMC 3016 Ingo Rucker Vol#: 439

EMC 3017 Rachel Antico Vol#: 439

EMC 3018 Becky Sandquist Vol#: 439

EMC 3019 CMAJAY1 Vol#: 439

EMC 3020 Palika Benton Vol#: 439

EMC 3021 Melanie Schuch Vol#: 439

EMC 3022 David Kimble Vol#: 439

EMC 3023 Patrisha A. Lowder Vol#: 439

EMC 3024 Sharon Hanna Vol#: 439

EMC 3025 Hiren Patel Vol#: 439

EMC 3026 Ligia Ercius-DiPalola Vol#: 439

EMC 3027 Bigplacid Vol#: 439

EMC 3028 Nancy Bruskin Vol#: 439

EMC 3029 Randy Scholfield Vol#: 439

EMC 3030 Pauline Tingas Vol#: 439

EMC 3031 W. Bryan Winget Vol#: 439

EMC 3032 Carol Radford Vol#: 439

EMC 3033 Shelly Nelson Vol#: 439

EMC 3034 R. Barnhardt Vol#: 439

EMC 3035 John & Brigitta Prentiss Vol#: 439

EMC 3036 Amy Carr Vol#: 439

EMC 3037 Julie Writer Vol#: 439

EMC 3038 Susan M. Fuller Vol#: 439

EMC 3039 Kathy Smiley Vol#: 439

EMC 3040 Allen Keith Tillotson Vol#: 439

EMC 3041 Trish Doherty Vol#: 439

EMC 3042 Richard Houghton Vol#: 439

EMC 3043 Owen Marcus Vol#: 439

EMC 3044 Barbara Sassower Vol#: 439

EMC 3045 Lynn Schmeidler Vol#: 439
 
 

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

EC 14 Miss Beverly Stone Vol#: 7
 
 

00D-0053 Reprocessing&Reuse of Single-Use Devices/Risk Categorization

GDL 4 Guidance (Single-Use Devices) Vol#: 7

NAD 3 Guidance (Single-Use Devices) Vol#: 7

00D-1277 Fumonisin Levels in Human Foods and Animal Feed

C 10 Grocery Manufacturers of America (GMA) Vol#: 4

C 11 Agricor Vol#: 4

C 12 American Society Microbiology Vol#: 4

00D-1305 Patulin in Apple Juice,Apple Juice Concentrates,Juice Produc

C 1 Processed Apples Institute Inc Vol#: 1

C 2 Nat'l Food Processors Assoc (NFPA) Vol#: 1

C 3 Nat'l Juice Products Assn Vol#: 1

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

C 3 Helen Hayes Hospital Vol#: 2

C 4 NPS Allelix Corp Vol#: 2

C 5 Lilly Research Laboratories Vol#: 2

C 6 Claude D Amaud MD Vol#: 2

C 7 Bristol-Myers Squibb Vol#: 2

C 8 Merck Research Laboratories Vol#: 2

LET 1 Lilly Research Laboratories Vol#: 2
 
 

00D-1383 Surveillance & Detention w/o Physical Examination of Condoms

GDL 1 Guidance for Industry Vol#: 1

NAD 1 Guidance for Industry Vol#: 1
 
 

00D-1401 Administrative Procedures for CLIA Categorization

GDL 1 Draft Guidance Vol#: 1

NAD 1 Vol#: 1
 
 

00M-1451 H990014; Enterra Therapy System

AAV 1 Medtronic, Inc. Vol#: 1

00N-0504 Egg Safety Action Plan

EMC 55 Madeline Ogle Vol#: 3

EMC 56 Donna Selquist Vol#: 3

EMC 57 Mr. & Mrs. J. L. Denison Vol#: 3

EMC 58 Glenn Cronick Vol#: 3

EMC 59 University of Miami/Advancement Division Vol#: 3

EMC 60 Audrey Vol#: 3

EMC 61 Suezinn Vol#: 3

EMC 62 Helping Hands for Little Paws Vol#: 3

EMC 63 Margie Kraft Vol#: 3

EMC 64 Kelley McAnally Vol#: 3

EMC 65 Alisa Alfaro Vol#: 3

EMC 66 Christina Johannes Vol#: 3

EMC 67 Susan Bell Vol#: 3

EMC 68 Cheryl Cooper Vol#: 3

EMC 69 Dana Cavallero Vol#: 3

EMC 70 Arezoo Rahmim, M.D. Vol#: 3

EMC 71 Rev. Lee Blackburn Vol#: 3

EMC 72 Patricia L. Palafox Vol#: 3

EMC 73 Michelle Kapusta Vol#: 3

EMC 74 Vicky Smith Vol#: 3

EMC 75 Frances McNair Vol#: 3

EMC 76 Aj Solomon Vol#: 3

EMC 77 Rebecca J. Blake Vol#: 3

EMC 78 Karen Ziomek Vol#: 3

EMC 79 Judith C. Mueller Vol#: 3

EMC 80 Sawtooth Tye Vol#: 3

EMC 81 JoAnn Hirata Vol#: 3

EMC 82 Kerri van Veen Vol#: 3

EMC 83 Chere M. Kypke Vol#: 3

EMC 84 Bay Gibbons Vol#: 3

EMC 85 Carolyn Denton Vol#: 3

EMC 86 Jennifer Johnson Vol#: 3

EMC 87 Mr. Bobbie D. Flowers Vol#: 3

EMC 88 Beverly Lemburg Vol#: 3

EMC 89 Lauren P. Bowling Vol#: 3

EMC 90 Bonnie & Robert West Vol#: 3

TR 1 Egg Saftey Public Meeting 3/30/00 Vol#: 4

TR 2 Implementing The Egg Safety Action Plan Vol#: 5
 
 

00N-1200 Dietary Supplements Containing Ephedrine Alkaloids

EC 5 Consumer Health Interactive Vol#: 62

EC 6 Number not used Vol#: 62

00N-1219 Bacterial Vaccines & Related Biological Products

EMC 1 Nancy E. Swain Vol#: 1
 
 

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

CH 314 Nurit Bloom Vol#: 16

CH 315 Mark Fradl Vol#: 16

CH 316 Kimberly Smith Vol#: 16

CH 317 Tracey Thiel Vol#: 16

CH 318 Amy Dole Vol#: 16

CH 319 Alise Dodds Vol#: 16

CH 320 Wendy Davidson, RN Vol#: 16

CH 321 Wendy Davidson, RN Vol#: 16

CH 322 Melinda Lee Vol#: 16

CH 323 Patrick Boe Vol#: 16

CH 324 Jacy Leonardo Vol#: 16

CH 325 Laura Dubnoff Vol#: 16

CH 326 Melissa Huhn Vol#: 16

CH 327 Tamar Gordon Vol#: 16

CH 328 Lynn & Kristine Cheatum Vol#: 16

CH 329 Jeff Koloze Vol#: 16

CH 330 Johanna Roebas Vol#: 16

CH 331 Annika McIntosh Vol#: 16

CH 332 Sylvia Broaderick Vol#: 16

CH 333 Reverend Marie Jones Vol#: 16

CH 334 Ronnie Savino Vol#: 16

CH 335 Jenni Vainik Vol#: 16

CH 336 Allison Urzua Vol#: 16

CH 337 Toni Carroll Vol#: 16

CH 338 Monica Matteo Vol#: 16

CH 339 Cathryn A. Hay, PhD Vol#: 16

CH 340 Vanessa Bilanceri Vol#: 16

CH 341 Karin Vol#: 16

CH 342 Alia Knowles Vol#: 16

CH 343 Susan Purviance Vol#: 16

CH 344 Jennifer Smith Vol#: 16

CH 345 David Robinson Vol#: 16

CH 346 Amanda Shelton Vol#: 16

CH 347 Thomas Christie Vol#: 16

CH 348 Martha Fox Vol#: 16

CH 349 Wendi Landreth Vol#: 16

CH 350 Chad Minsky Vol#: 16

CH 351 Dr. Anna Rubin Vol#: 16

CH 352 trudynep Vol#: 16

EC 427 University of Texas at Arlington Vol#: 14

EC 428 Mr. Gary Henkaline Vol#: 14

EC 429 Citizen Vol#: 14

EC 430 Miss georgine guettler Vol#: 14

EC 431 Mr. Jimmy Rowland Vol#: 14

EC 432 na Vol#: 14

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

EC 6 Ms. Diana Artemis Vol#: 1

EC 7 Ms. Judi Bondi Vol#: 1

EC 8 Ms. Jan Walters Vol#: 1

EC 9 Mr. james stevens Vol#: 1

EC 10 Mr. Neil McConlogue Vol#: 1

EC 11 None Vol#: 1

EC 12 Mr. Jack Brown Vol#: 1

EC 13 Mr. Robert Hanson Vol#: 1

EC 14 human kind Vol#: 1

EC 15 Mr. Bobbie Flowers Vol#: 1

EC 16 Ms. Christine Olah Vol#: 1

EC 17 Japan Offspring Fund Vol#: 1

EC 18 Number not used Vol#: 1

EC 19 Self Vol#: 1

EC 20 Ms. Gailynn Valdes Vol#: 1

EC 21 Ms. D. Jennifer Hewitt Vol#: 1

EC 22 USDA, FSIS Vol#: 1

EC 23 Mrs. Sheilla Rekdal Vol#: 1

EC 24 Mr. Tony Dziepak Vol#: 1

EC 25 marketingplan.com Vol#: 1

EC 26 Mr. Ryan Boley Vol#: 1

EC 27 Ms. Corina Gasner Vol#: 1

TR 1 Public Meeting 7/21/2000 Vol#: 2
 
 

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

C 7 International Academy of Compounding Phm Vol#: 1

C 8 Schering Corporation Vol#: 1

C 9 U S Pharmacopeia (USP) Vol#: 1

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

EXT 2 Hyman, Phelps & McNamara, P.C. Vol#: 1

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

C 3 Cepheid Vol#: 1

00P-0653 Amend the product insert &/or label for Anthrax Vaccive adso

LET 1 HFM-1 to Mark S Zaid Vol#: 1

00P-1227 Amend Statements Made for Dietary Supplements

C 1 M. C. Mead Vol#: 1

00V-1459 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Burning Man Vol#: 1