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] 

DOCKETS ENTERED on April 17, 2000

Table of Contents

(Hyper links are part of the Docket  title - not all dockets/documents are linked)

[FDA DOCKETS PAGE][FDA HOME PAGE]  [ ITEM CODES ]
 
91N-0098 Dietary Fiber & Cancer, Health Claims & Label Statements *
94P-0390 Adopt Amendments Governing Health Claims & Nutrient Claims *
95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient *
95P-0241 Implied Nutrient Content Claim "Healthy" & Health Claims *
97N-0436 Methods informing consumers of contents of bottle water *
97P-0078 Recognized the Term "Soymilk" as the Established Common of U *
98P-0145 Requirements for demonstrating In Vivo Bioequivalence *
99D-4114 Testing for Replication Competent Retrovirus in Retroviral *
99D-5297 Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer *
99D-5435 Draft Guidance for Industry on Photosafety Testing *
99N-4491 Reuse of Single Use Devices proposal *
99N-4783 Administrative Practices & Procedures;Good Guidance Practice *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
99P-4848 Carbinoxamine Maleate 4 mg/5 cc Elixir *
00N-0504 Egg Safety Action Plan *
00P-1225 ANADA Suitability for Ivermectin Liquid for Horses *
00V-1260 Laser light show*
91N-0098 Dietary Fiber & Cancer, Health Claims & Label Statements

THIS LINKED COMMENT DUPLICATES THOSE FOR 91N-0101, -0103, AND 100H, ALSO BELOW

C 125 National Food Processors Association Vol#: 25

91N-0101 Antioxidant Vitamins & Cancer,Hlth. Claims & Label Statement

C 181 National Food Processors Association Vol#: 40

91N-0103 Fatty Acids & Heart Disease, Hlth.Claims & Label Statements

C 126 National Food Processors Assn Vol#: 58

91N-100H Health Claims & Label Statements; Folate & Neural Tube Defec

C 106 National Food Processors Assn Vol#: 15

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

C 2094 Ruthie Newman Vol#: 59

C 2095 Kellog's Vol#: 59

C 2096 Hershey Foods Vol#: 59

C 2097 Willy Putra Vol#: 59

C 2098 Surijati Daud Vol#: 59

C 2099 Burhan Vol#: 59

C 2100 Edo Wijaya Vol#: 59

C 2101 Tio Hing Foe Vol#: 59

C 2102 unsigned Vol#: 59

C 2103 The Peanut Institute Vol#: 59

C 2104 Gladys V. O'Brien Vol#: 59

C 2105 Mary Ellen Gavin Vol#: 59

C 2106 American Frozen Food Institute Vol#: 59

C 2107 Health Canada Health Protection Branch Vol#: 59

C 2108 National Cattlemen's Beef Association Vol#: 59

C 2109 Cultor Food Science Inc. Vol#: 59

C 2110 United Coconut Associations Vol#: 59

C 2111 AARP Vol#: 59

C 2112 Frozen Potato Products Institute Vol#: 59

EC 2 Ms. robbie morris Vol#: 58

EC 3 Mr. Richard Norton Vol#: 58

EC 4 Mrs. Jessie Powers Vol#: 58

EC 5 Mr. John DiPietro Vol#: 58

EC 6 Mrs. Alice Kelly Vol#: 58

94P-0390 Adopt Amendments Governing Health Claims & Nutrient Claims

C 59 National Food Processors Assn Vol#: 5

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

EMC 1 K. M. Kovalcsik Vol#: 4

EMC 2 Carol Pikula Vol#: 4

95P-0241 Implied Nutrient Content Claim "Healthy" & Health Claims

C 77 National Food Processors Assn Vol#: 8

96P-0498 Prednisolone Sodium Phosphate Oral Chewable Tablet

WDL 1 We Pharmaceuticals, Inc. Vol#: 1

97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container

REF 1 HF-26 Vol#: 200

97N-0074 President's National Food Safety Initiative

C 248 Nancy Skwarek Vol#: 22

97N-0436 Methods informing consumers of contents of bottle water

C 53 Sparkling Spring Water Co. Vol#: 1

C 54 Jean E. Mitchell Vol#: 1

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

C 12 Soyfoods Association of North America Vol#: 1

98P-0145 Requirements for demonstrating In Vivo Bioequivalence

C 19 Andrx Pharmaceuticals, Inc. Vol#: 6

99D-4114 Testing for Replication Competent Retrovirus in Retroviral

EMC 1 Alex Stevenson Vol#: 1

99D-5297 Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer

C 1 Datex-Ohmeda, Inc. Vol#: 1

99D-5435 Draft Guidance for Industry on Photosafety Testing

C 6 Beth Israel Deaconess Medical Center Vol#: 1

C 7 PhRMA Vol#: 1

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

C 7440 Barry & Susan Portney Vol#: 318

C 7441 Joyce E. Frohn Vol#: 318

C 7442 Charles Attal Vol#: 318

C 7443 Roger A. Baker Vol#: 318

C 7444 Illegible Vol#: 318

C 7445 Mary Lee Vol#: 318

C 7446 Ms. Estelle Lynch Vol#: 318

C 7447 Troy A. Jerrils Vol#: 318

C 7448 Darius Victor Vol#: 318

C 7449 Tasha Montello Vol#: 318

C 7450 Sandy & Andy Clark Vol#: 318

C 7451 Doris Syverson Vol#: 318

C 7452 Mary E. Sunderman Vol#: 318

C 7453 Tim Hammonds Vol#: 318

C 7454 Frances D. Smith Vol#: 318

C 7455 Tara Treasurefield Vol#: 318

C 7456 Gretchen Mayer Vol#: 318

C 7457 Nicole Peyrafitte Vol#: 318

C 7458 Betty Kirzinger Vol#: 318

C 7459 Nansea Goldberg Vol#: 318

C 7460 Kimberly K. Schultz Vol#: 318

C 7461 Ben & Amy Cornelius Vol#: 318

C 7462 Kelly Love Sanborn Vol#: 318

C 7463 William Donald Stanford Vol#: 318

C 7464 Lorene Lynn Vol#: 318

C 7465 Illegible Vol#: 318

C 7466 Nancy H. Carter Vol#: 318

C 7467 Louis S. Campbell Vol#: 318

C 7468 H. Langae Vol#: 318

C 7469 Adele Bender Vol#: 318

C 7470 Jean Franklin Phd. Vol#: 318

C 7471 Mr & Mrs Russell Gellis Vol#: 318

C 7472 William Amory Potter, Jr. Vol#: 318

C 7473 Betty Light Vol#: 318

C 7474 Walter Hl McGee Vol#: 318

C 7475 Jon Powasnick Vol#: 318

C 7476 R. Butt Vol#: 318

C 7477 Rex Bristol Vol#: 318

C 7478 Will Snodgrass Vol#: 318

C 7479 Marvin E. Molberg Vol#: 318

C 7480 Tienne Beaulieu Vol#: 318

C 7481 Margarett D. Nieto Vol#: 318

C 7482 Gilbert M. Friedmann Vol#: 318

C 7483 Rob Nangle Vol#: 318

C 7484 R. Zane Carter Vol#: 318

C 7485 Teresa Petersen Vol#: 318

C 7486 Margaret M. Anderson Vol#: 318

C 7487 Margaret H. Titus Vol#: 318

C 7488 Kristin Berger Vol#: 318

C 7489 Marcella Teran Vol#: 318

C 7490 D. G. VanArsdale Vol#: 318

C 7491 Nancy A. Minton Vol#: 318

C 7492 Dorothy Humphreys Vol#: 318

C 7493 Stephanie Reader Vol#: 318

C 7494 Angelia Econopouly Vol#: 318

C 7495 Molly Fisher Vol#: 318

C 7496 Pat Perla Vol#: 318

C 7497 Jacs Brusscato Vol#: 318

C 7498 Gloria Shelf Vol#: 318

C 7499 Pam Quiby & Pam Kolimb Vol#: 318

C 7500 Ronald F. Dale Vol#: 318

C 7501 Ester Johansson Murray Vol#: 318

C 7502 Hyla Fetler Vol#: 318

C 7503 Jo Shanna Bash Vol#: 318

C 7504 John Savlov Vol#: 318

C 7505 Patricia Crosby Vol#: 318

C 7506 Steven L. Wilbur Vol#: 318

C 7507 A. R. Delrect Vol#: 318

C 7508 Cosette A. Dudley Vol#: 319

C 7509 Glenn C. White Vol#: 319

C 7510 George Lawrence Vol#: 319

C 7511 Shulamit Lazarus Vol#: 319

C 7512 Eugene Brossman Vol#: 319

C 7513 Charlotte Van Hoozier, MD Vol#: 319

C 7514 Todd Wodd + 248 signatures Vol#: 319

C 7515 Vicki McAfee + 4 signatures Vol#: 319

C 7516 Carl R. Littmann Vol#: 319

C 7517 The Allens Family Vol#: 319

C 7518 Dolores Tippett Vol#: 319

C 7519 Cynthia Anderson Vol#: 319

C 7520 Mary Wilson Vol#: 319

C 7521 Kris Wagar Vol#: 319

C 7522 Clayton Austin Vol#: 319

C 7523 Jim Loretta Vol#: 319

C 7524 Debra Kratzenberg Vol#: 319

C 7525 Jacqui Compton-Jensen Vol#: 319

C 7526 Margaret Pich Vol#: 319

C 7527 Kelly Pascucci Vol#: 319

C 7528 Grace Sevy Vol#: 319

C 7529 Neal E. Wankoff Vol#: 319

C 7530 Marcia S. Dunning Vol#: 319

C 7531 Kate Hinkle Vol#: 319

C 7532 Wendy Berkowitz Vol#: 319

C 7533 Chris & Sue Constable Vol#: 319

C 7534 Sandra Smothers Vol#: 319

C 7535 Peter Hassler Vol#: 319

C 7536 Natalie Janis Vol#: 319

C 7537 R. Gion Vol#: 319

C 7538 Laura Schmidt Vol#: 319

C 7539 Carolyn Apsey Vol#: 319

C 7540 Bill & Marilyn Kellar Vol#: 319

C 7541 Chivinph Vol#: 319

C 7542 Erin Russell Vol#: 319

C 7543 Kay Cook & Perry Pogony Vol#: 319

C 7544 Barbara McCollom Vol#: 319

C 7545 Tagan Dare Vol#: 319

C 7546 Marie Rippa Vol#: 319

C 7547 Linda Hibbs Vol#: 319

C 7548 T. Ermini Vol#: 319

EMC 2032 Carol McCarter Vol#: 317

EMC 2033 Carl Arnold Vol#: 317

EMC 2034 Lori E. McBride Vol#: 317

EMC 2035 Al S. Max Vol#: 317

EMC 2036 Jim Brown Vol#: 317

EMC 2037 John A. Webster, Jr. Vol#: 317

EMC 2038 Robert Seyko, M. D. Vol#: 317

EMC 2039 Daniel Weise Vol#: 317

EMC 2040 Irena Franchi Vol#: 317

EMC 2041 John Klowes Vol#: 317

EMC 2042 Debbie Ortman Vol#: 317

EMC 2043 Mrs. Ralph Sandler Vol#: 317

EMC 2044 Mark & Barbara Sweeny Vol#: 317

EMC 2045 Teresa Smigelski Vol#: 317

EMC 2046 Heidi Weldon Vol#: 317

EMC 2047 Dawn M. Dinoto Vol#: 317

EMC 2048 Janette Misic Vol#: 317

EMC 2049 Suzanne Alford Vol#: 317

EMC 2050 Cheri Lovre Vol#: 317

EMC 2051 Megan Baker Vol#: 318

EMC 2052 Lisa Swallow Vol#: 318

EMC 2053 Tony Conrad Vol#: 318

EMC 2054 Pamela Z. Blum Vol#: 318

EMC 2055 Charlotte Sornborger Vol#: 318

EMC 2056 Joannes Pool Vol#: 318

EMC 2057 Oona Coy Vol#: 318

EMC 2058 Patricia Jackson Vol#: 318

EMC 2059 Freda Elliott Vol#: 318

EMC 2060 Susan KcKeown Vol#: 319

EMC 2061 Cassandra Pierson Vol#: 319

EMC 2062 Sandra Raymond Vol#: 319

EMC 2063 Justin Forster Vol#: 319

EMC 2064 Jennifer Knipe-Blaine Vol#: 319

EMC 2065 Jenny Prokos Vol#: 319

EMC 2066 Marian Cooley Vol#: 319

EMC 2067 Martin A. Rabbett Vol#: 319

EMC 2068 Delbert Raymond Vol#: 319

EMC 2069 Kathleen Watkins Vol#: 319

EMC 2070 Marlene Sheridan Vol#: 319

EMC 2071 Ralph W. Marsh Vol#: 319

EMC 2072 Janeet Cameron Duffy Vol#: 319

99N-4491 Reuse of Single Use Devices proposal

C 112 Huguley Health System Vol#: 7

C 113 Rome Memorial Hospital Vol#: 7

C 114 Mendocino Coast District Hospital Vol#: 7

C 115 Cumberland Medical Center Vol#: 7

C 116 The Childrens Hospital Vol#: 7

C 117 Saint Elizabeth Regional Medical Center Vol#: 7

C 118 Shrines Hospitals for Children Chicago Vol#: 7

C 119 Wake Forest University Baptist Med. Cntr Vol#: 7

C 120 Wake Forest University Baptist Med. Cntr Vol#: 7

C 121 Wake Forest University Baptist Med. Cntr Vol#: 7

C 122 Huguley Health System Vol#: 7

99N-4783 Administrative Practices & Procedures;Good Guidance Practice

C 4 Daniel Kearns Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

EMC 43 Judith Sartell Vol#: 185

99P-4848 Carbinoxamine Maleate 4 mg/5 cc Elixir

ANS 1 Mikart, Incorporated Vol#: 1

00H-0658 Civil Money Penalty;Robert Ross,dba Ross Grocery

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0746 Civil Money Penalty;Floyd Williams,dba Dick & Floyd's Libert

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0777 Civil Money Penalty:Jeannie Moyer dba Gold Canyon Star Mart,

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0778 Civil Money Penalty:Ashita Patel dba Alameda Exxon,

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0779 Civil Money Penalty:Khaled Said dba Big Save Market,

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0780 Civil Money Penalty:Na Song dba People's Supermarket,

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0781 Civil Money Penalty:Tedeschi Food Shops Inc dba Tedeschi Foo

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0782 Civil Money Penalty:Walgreen Co dba Walgreens Drug Store4066

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0783 Civil Money Penalty:Walgreen Co dba Walgreens Drug Store5195

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0793 Civil Money Penalty;Cloverland Farms Dairy Incorporated,dba

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0795 Civil Money Penalty;Farawi & Saqqa Inc,dba K-Discount Outlet

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0796 Civil Money Penalty;Paul E Fry,dba Stop & Go

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0799 Civil Money Penalty;Lemmen Oil Company,dba Lemmen Oil Compan

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0800 Civil Money Penalty;Julius S O'Neal,dba Philadelphia Superet

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0802 Civil Money Penalty;Mickey D Tenney,dba Fast Stop Food Mart

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0803 Civil Money Penalty;Wenjest Corporation,dba Williams Grocery

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0807 Civil Money Penalty;Waken Investments Inc,dba Easy Stop Groc

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0815 Civil Money Penalty;Mary A. Lane,dba Pic N Pac

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00N-0001 Leveraging - Collaborating with Stakeholders

C 3 American Veterinary Medical Association Vol#: 1

C 4 American Medical Association Vol#: 1

LST 3 Agenda for 4/12/00 meeting Duke Universi Vol#: 3

LST 4 Duke University Presenters Vol#: 3

REF 2 For 4/12/00 meeting Duke University Vol#: 3

TS 5 Ground Zero Pharmaceutical Inc Vol#: 1

TS 6 Breast Cancer Action Vol#: 1

TS 7 Breast Cancer Action Vol#: 1

TS 8 Ground Zero Pharmaceutical Inc Vol#: 1

TS 9 STOP - Safe Tables Our Priority Vol#: 1

TS 10 Roche Diagnostics Vol#: 1

TS 11 STOP - Safe Tables Our Priority Vol#: 1

TS 12 June M Fishers MD Vol#: 1

TS 13 Calydon Vol#: 1

TS 14 Duke University Vol#: 3

TS 15 SAS Intitute Inc Vol#: 3

TS 16 SAS Intitute Inc Vol#: 3

TS 17 SNP Consortium Ltd Vol#: 3

TS 18 Human Milk Banking Assn of N A Inc Vol#: 3

TS 19 Human Milk Banking Assn of N A Inc Vol#: 3

TS 20 NC Healthcare Information & Communicatio Vol#: 3

TS 21 Dr William McCready Vol#: 3

TS 22 Meharry Medical College Vol#: 3

TS 23 Internet Healthcare Coalition Vol#: 3

TS 24 Centersfor Education & Research in Thera Vol#: 3

TS 25 American Society for Quality Vol#: 3

00N-0358 Technical Implementation of Electronic Records and Electroni

C 1 PhRMA Vol#: 1

00N-0504 Egg Safety Action Plan

C 2 U. S. Poultry & Egg Association Vol#: 1

TS 1 MC Anally Enterprises, Inc Vol#: 1

00N-0598 Dietary Supplement Health Claim/Implementation of Pearson De

EMC 20 Elizabeth F. Winstead Vol#: 2

00P-1225 ANADA Suitability for Ivermectin Liquid for Horses

SUP 1 Equi Aid Products, Inc Vol#: 1

00V-1260 Laser light show

ACK 1 HFA-305 Vol#: 1

VAR 1 American Music Co. Vol#: 1