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 July 31, 2001

TABLE OF CONTENTS

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78N-036L OTC Laxative *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99F-4372 National Fisheries Institute and the Louisiana Dep of Agricu *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00F-1482 Safe use of ozone in gaseous & aqueous phases as antimicrobi *
00P-1322 Food Labeling and Allergen Contamination Control *
00P-1486 ANADA Suitability Petition for a Generic Oral Ivermectin *
00P-1574 ANDA Suitability Petition for Potassium Lodide 65 mg Tablets *
00P-1594 ANADA for Invermectin *
00P-1600 ANADA Suitability for Ivermectin *
01D-0194 Statistical Aspects Design,Analysis,Interpretation,chronic *
01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC *
01P-0230 Domestic Marketing & Importation of Transgenic Fish *
78N-036L OTC Laxative

LET 190 C. B. Fleet, Co. Vol#: 107

PDN 11 HFC-1 to C. B. Fleet Company Inc Vol#: 107

97P-0130 Require Percentage Ingredient Labeling

C 5 FORM LETTER COUNT 2 Vol#: 2

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

C 5086 William Burgess Vol#: 159

C 5087 Rachel Meltzer Vol#: 159

C 5088 Paul F. Cunningham & Suzanne Kournier Vol#: 159

C 5089 Kimberly Hale Vol#: 159

C 5090 Deborah C. Russell Vol#: 159

C 5091 Candace Colby Vol#: 159

C 5092 Linda Nicholas Vol#: 159

C 5093 James P. Loughlin Vol#: 159

C 5094 Suzanne Stetson Vol#: 159

C 5095 Diana Artemis Vol#: 159

C 5096 Jacqueline L. Price Vol#: 159

C 5097 Kathy Paolella Vol#: 159

C 5098 Audrey P. Drugnick Vol#: 159

C 5099 R. R. Reynolds Vol#: 159

EMC 2225 Terry Dalton Vol#: 159

EMC 2226 Shelly S. Bird Vol#: 159

EMC 2227 Tanya Morris Vol#: 159

EMC 2228 Ashley Bray Vol#: 159

EMC 2229 Lynda D. Hardman Vol#: 159

EMC 2230 Jan Stern Vol#: 159

EMC 2231 Judy Reed Vol#: 159

EMC 2232 Robin Gustus Vol#: 159

EMC 2233 Holly Colasurdo Vol#: 159

EMC 2234 Cora Lee Healy Vol#: 159

EMC 2235 June Yamrick Vol#: 159

EMC 2236 Kip Bellairs Vol#: 159

EMC 2237 Pamela Austrich Vol#: 159

EMC 2238 Gundel Bhutani Vol#: 159

EMC 2239 Caroline Y. Pak Vol#: 159

EMC 2240 Carol Zdravkovic Vol#: 159

EMC 2241 Ellen Einkauf Vol#: 159

99F-4372 National Fisheries Institute and the Louisiana Dep of Agricu

EMC 13 Allison Williams Vol#: 2

EMC 14 Ingrid Tillman Vol#: 2

EMC 15 Aajonus Vonderplanitz Vol#: 2

EMC 16 Robert Ratliff Vol#: 2

EMC 17 Mary E Marucci Vol#: 2

EMC 18 Gwen Dickerson Vol#: 2

EMC 19 Malcolm Gold Vol#: 2

EMC 20 David F Darin Vol#: 2

EMC 21 Clifton Bain Vol#: 2

EMC 22 Vince Sims Vol#: 2

EMC 23 Ninon Aprea Vol#: 2

EMC 24 Steve Hamlin Vol#: 2

EMC 25 Dorothy McIver Vol#: 2

EMC 26 Leila Rajabain Vol#: 2

EMC 27 Oona Mourier PhD Vol#: 2

EMC 28 Daleena Dancer Vol#: 2

EMC 29 Deborah Boyar Vol#: 2

EMC 30 Susan Collins Vol#: 2

EMC 31 Nesa R Weir Vol#: 2

EMC 32 Ray Mackie Vol#: 2

EMC 33 Jim Wilson Vol#: 2

EMC 34 Bruce Portmann Vol#: 2

EMC 35 Melissa Crandall Vol#: 2

EMC 36 Kimberlee Lauer Vol#: 2

EMC 37 Jan Walters Vol#: 2

EMC 38 Irene Swaminathan Vol#: 2

EMC 39 Shirley Lipschutz-Robinson Vol#: 2

EMC 40 Carol Dombrovski Vol#: 2

EMC 41 Marcia Hoodwin Vol#: 2

EMC 42 Tavia Lin Gilbert Vol#: 2

EMC 43 Sheryl Ramos Vol#: 2

EMC 44 Jennifer Brownson Vol#: 2

EMC 45 James Hopson Vol#: 2

EMC 46 Maggie Fishman Vol#: 2

EMC 47 Loretta L Flaugher Vol#: 2

EMC 48 Charles T Day Vol#: 2

EMC 49 Steve Ochi Vol#: 2

EMC 50 Adam Hancock Vol#: 2

EMC 51 Marcia Downs Vol#: 2

EMC 52 Daniel Kane Vol#: 2

EMC 53 Mitzi Bowman Vol#: 2

EMC 54 Mark Crosby Vol#: 2

EMC 55 A Terry Patten Vol#: 2

EMC 56 Alfredo Urso Vol#: 2

EMC 57 Andrea Klein Vol#: 2

EMC 58 Susan Udry Vol#: 2

EMC 59 Zinaida Zybach Vol#: 2

EMC 60 Shira EtShalom Vol#: 2

EMC 61 Judith Bourque Vol#: 2

EMC 62 Brian Smythe Vol#: 2

EMC 63 Bill & Gloria Addington Vol#: 2

EMC 64 Tommy K I Vol#: 2

EMC 65 Christine Olah Vol#: 2

EMC 66 Kurt A Krueger Vol#: 2

EMC 67 Hans E Eisenman Vol#: 2

EMC 68 Chris Fayz Vol#: 2

EMC 69 Miriam Reed Vol#: 2

EMC 70 Jason Sartor Vol#: 2

EMC 71 NUMBER NOT USED Vol#: 2

EMC 72 Mercedes Kirkel Vol#: 2

EMC 73 David Caccia Vol#: 2

EMC 74 Lore Hiney Vol#: 2

EMC 75 Travis Robb Vol#: 2

EMC 76 Jeff Hatcher Vol#: 2

EMC 77 Odette Springer Vol#: 2

EMC 78 Dr Denis R Bettencourt Vol#: 2

EMC 79 Sara Staehle Vol#: 2

EMC 80 Dr Susan Kay Udry Vol#: 2

EMC 81 David E Bresler PhD Vol#: 2

EMC 82 Charles Weiss Vol#: 2

EMC 83 Hannah Rappaport Vol#: 2

EMC 84 Jeff House Vol#: 2

EMC 85 Udana Power Vol#: 2

EMC 86 Eva Dale Vol#: 2

EMC 87 Glenn Fischel Vol#: 2

EMC 88 Hagay Brafman Vol#: 2

EMC 89 Janice W Neitzel Vol#: 2

EMC 90 Brant Lyon Vol#: 2

EMC 91 P A Bevan Chan Vol#: 2

EMC 92 Kimberly A Dennig Vol#: 2

EMC 93 Elizabeth Hubert Vol#: 2

EMC 94 Marilyn Gausewitz Vol#: 2

EMC 95 Margaret A Phanes Vol#: 2

EMC 96 Michele M Makrucki Vol#: 2

EMC 97 Rocky Lau Vol#: 2

EMC 98 Scott Williams Vol#: 2

00D-1598 Voluntary Labeling for Bioengineered Foods

C 6081 Elisabeth Parker Vol#: 410

C 6082 Eleanor McCracken Vol#: 410

C 6083 Organic Consumers Association Vol#: 410

C 6084 Jamie Lantz Vol#: 410

C 6085 Tracina Jackson-Adams Vol#: 410

C 6086 Jude and Jerome Hobbs Vol#: 410

C 6087 Donna Woodward Vol#: 410

C 6088 Alan Boyer Vol#: 410

C 6089 Michael Brake Vol#: 410

C 6090 Mauro Ivan Pena Vol#: 410

C 6091 Joyce Yerger Vol#: 410

C 6092 Elaine & Jerry Caya Vol#: 410

C 6093 Jerry Reilly Vol#: 410

C 6094 Carol R. Morrison Vol#: 410

C 6095 Sonnet Dashevskaya Vol#: 410

C 6096 Dr. Joel Popson Vol#: 410

C 6097 Katy Christianson Vol#: 410

C 6098 Chris Segal Vol#: 410

C 6099 Gerald Howard Axford Junior Vol#: 410

C 6100 Kathleen Anderson Vol#: 410

C 6101 Werner Hertz Vol#: 410

C 6102 No Signature Vol#: 410

C 6103 Eligible Vol#: 410

C 6104 Mary Ellen Clinton & Diana Kaye Vol#: 410

C 6105 Kelleigh McMillan Vol#: 410

C 6106 Adianne Virginia Wallace Vol#: 410

C 6107 Trish Haas Vol#: 410

C 6108 Amy Schofield Vol#: 410

C 6109 Theodora Kerry Vol#: 410

C 6110 Mary Smith Vol#: 410

C 6111 Edward G. Ayoub Vol#: 410

C 6112 Harry S. Lederman Vol#: 410

C 6113 Sandy Gooch Enterprises Inc. Vol#: 410

C 6114 C. Barrett Vol#: 410

C 6115 Sue Ellen Davis Vol#: 410

C 6116 Pamela & Phil Ager Vol#: 410

C 6117 John Wages Vol#: 410

C 6118 Craig Edwards Vol#: 410

C 6119 Amy Moore Vol#: 410

C 6120 James N. Gruber Jr. Vol#: 410

C 6121 Floydard Ada Mae Hoover Vol#: 410

C 6122 David J. Berger Vol#: 410

C 6123 Patricia L. House Vol#: 410

EMC 10036 Patricia Anne McQuerry Vol#: 409

EMC 10037 Candice Roeder Vol#: 409

EMC 10038 Jan Jasik Vol#: 409

EMC 10039 Eric Olson Vol#: 409

EMC 10040 Eric Olson Vol#: 409

EMC 10041 Dr. Alan Hunter Vol#: 409

EMC 10042 Arthur Rochester Vol#: 409

EMC 10043 Barbara Janeway Vol#: 409

EMC 10044 Richard Morris Vol#: 409

EMC 10045 Catherine Smith Vol#: 409

EMC 10046 Marina Marelic Vol#: 409

EMC 10047 Amy Luper Vol#: 409

EMC 10048 Elinar Olsen Vol#: 409

EMC 10049 John Minton Vol#: 409

EMC 10050 John Minton Vol#: 409

EMC 10051 Ian Krieger Vol#: 409

EMC 10052 Ian Krieger Vol#: 409

EMC 10053 Don Rake Vol#: 409

EMC 10054 Don Rake Vol#: 409

EMC 10055 Marja Scheeres and Donna Paylor Vol#: 409

EMC 10056 Eugene I Shapiro Vol#: 409

EMC 10057 Paul Nicholson Vol#: 409

EMC 10058 Paul Nicholson Vol#: 409

EMC 10059 George Zipfel Vol#: 409

EMC 10060 George Zipfel Vol#: 409

EMC 10061 Ynez Crawford-Taylor Vol#: 409

EMC 10062 Tuyet Nguyen Vol#: 409

EMC 10063 Eva Swidler Vol#: 409

EMC 10064 Eva Swidler Vol#: 409

EMC 10065 Allen Zerkin Vol#: 409

EMC 10066 Beca Hull-Foster Vol#: 409

EMC 10067 Beca Hull-Foster Vol#: 409

EMC 10068 Phillip Fujiyoshi Vol#: 409

EMC 10069 Phillip Fujiyoshi Vol#: 409

EMC 10070 K. Buhrmaster Vol#: 409

EMC 10071 Dolores Kaufman Vol#: 409

EMC 10072 Dolores Kaufman Vol#: 409

EMC 10073 Tom Bassler Vol#: 409

EMC 10074 Christos Talanoz Vol#: 409

EMC 10075 Mindy Myer Vol#: 409

EMC 10076 Chris Darling Vol#: 409

EMC 10077 Chris Darling Vol#: 409

EMC 10078 Barbara J. Fuller Vol#: 409

EMC 10079 Barbara J. Fuller Vol#: 409

EMC 10080 Carie Zierer Vol#: 409

EMC 10081 Helen Sanders Vol#: 409

EMC 10082 Helen Sanders Vol#: 409

EMC 10083 Greg Smith Vol#: 409

EMC 10084 Linda Kaiser Vol#: 409

EMC 10085 Jean Gahan Vol#: 409

EMC 10086 Neal Melton Vol#: 409

EMC 10087 Neal Melton Vol#: 409

EMC 10088 Susan Cox Vol#: 409

EMC 10089 Gie Swinnen Vol#: 409

EMC 10090 Grian MacGregor Vol#: 409

EMC 10091 Susan Davis Vol#: 409

EMC 10092 Susan Davis Vol#: 409

EMC 10093 unsigned Vol#: 409

EMC 10094 Wendy Davis, Ph.D. Vol#: 409

EMC 10095 Sridhar Vol#: 409

EMC 10096 Jo Kirkpatrick Vol#: 409

EMC 10097 Jo Kirkpatrick Vol#: 409

EMC 10098 Joanna Kirkpatrick, Ph.D. Vol#: 409

EMC 10099 Joe Smith Vol#: 409

EMC 10100 Laura Maciuika Vol#: 409

EMC 10101 Laura Maciuika Vol#: 411

EMC 10102 Kathleen Michaud Vol#: 411

EMC 10103 Kathleen Michaud Vol#: 411

EMC 10104 David Kratz Mathies Vol#: 411

EMC 10105 Jacqueline Nunez de Villavicencio Vol#: 411

EMC 10106 Catherine Feord Vol#: 411

EMC 10107 Erin Wilson Vol#: 411

EMC 10108 Marietta Ainsworth Vol#: 411

EMC 10109 Marietta Ainsworth Vol#: 411

EMC 10110 David Kuebrich Vol#: 411

EMC 10111 David Kuebrich Vol#: 411

EMC 10112 Garret Whitney Vol#: 411

EMC 10113 Michael G. Sims Vol#: 411

EMC 10114 Martina Janssen Vol#: 411

EMC 10115 Steven Coon Vol#: 411

EMC 10116 Jan Kennedy Vol#: 411

EMC 10117 Cathryn Baillie Vol#: 411

EMC 10118 Cathryn Baillie Vol#: 411

EMC 10119 Tom Davis Vol#: 411

EMC 10120 Tom Davis Vol#: 411

EMC 10121 Jack and Judy Speer Vol#: 411

EMC 10122 Mark Kapner Vol#: 411

EMC 10123 Mark Kapner Vol#: 411

EMC 10124 Barbara Szymanski Vol#: 411

EMC 10125 Barbara Szymanski Vol#: 411

EMC 10126 number not used Vol#: 411

EMC 10127 number not used Vol#: 411

EMC 10128 number not used Vol#: 411

EMC 10129 number not used Vol#: 411

EMC 10130 Scott Rice Vol#: 411

EMC 10131 Scott Rice Vol#: 411

EMC 10132 Nyasa Sala Kingslow Vol#: 411

EMC 10133 Nyasa Sala Kingslow Vol#: 411

EMC 10134 Andy Phoenix Vol#: 411

EMC 10135 Kate McCool Vol#: 411

EMC 10136 Kate McCool Vol#: 411

EMC 10137 Michael Diamond Vol#: 411

EMC 10138 Valerie Graham Vol#: 411

EMC 10139 Bonnie Kogod Vol#: 411

EMC 10140 David M. Orens Vol#: 411

EMC 10141 Peter Burkard Vol#: 411

EMC 10142 Peter Burkard Vol#: 411

EMC 10143 Brenda Leahy Vol#: 411

EMC 10144 Carol Agle Vol#: 411

EMC 10145 Carol Agle Vol#: 411

EMC 10146 Paul Previte Vol#: 411

EMC 10147 Theresa Senn Vol#: 411

EMC 10148 Sr. Janet Lewis Vol#: 411

EMC 10149 Lawrence Peryer Vol#: 411

EMC 10150 Lawrence Peryer Vol#: 411

EMC 10151 Muzza Eaton Vol#: 411

EMC 10152 Muzza Eaton Vol#: 411

EMC 10153 unsigned Vol#: 411

EMC 10154 Kelly Hanlon Vol#: 411

EMC 10155 Rachel K. Jones Vol#: 411

EMC 10156 Rachel K. Jones Vol#: 411

EMC 10157 Kara MacKeigan Vol#: 411

00F-1482 Safe use of ozone in gaseous & aqueous phases as antimicrobi

HER 1 Public Citizen Vol#: 1

00P-1322 Food Labeling and Allergen Contamination Control

APE 19 PA State Unversity Vol#: 13

APE 20 CHPA Vol#: 13

APE 21 Keller & Heckman Law Firm Vol#: 13

APE 22 FDA Vol#: 13

APE 23 FDA Vol#:

APE 24 CFSAN/FDA Vol#: 13

APE 25 Schreiber Foods Inc Vol#: 13

APE 26 Roche Vitamins Inc Vol#: 13

APE 27 Kerry Inc Vol#: 13

APE 28 Bestfoods Baking Company Vol#: 13

APE 29 The Kellen Company Vol#: 13

APE 30 Almond Board of CA Vol#: 13

APE 31 H J Heinz Company Vol#: 13

APE 32 Pfizer Inc Vol#: 13

APE 33 CFSAN/FDA Vol#: 13

APE 34 Assoc of Food & Drug Officials Vol#: 13

APE 35 NY Env Protection Bureau Vol#: 13

C 193 Brenda Hicks Vol#: 13

C 194 Mike & Teresa Fremaux Vol#: 13

C 195 Irene Schneiderman Vol#: 13

C 196 Candace Coleman Vol#: 13

C 197 Eileen Enteman Vol#: 13

C 198 Beth Dworjanyn Vol#: 13

C 199 Robert A Nakamae Vol#: 13

C 200 Barbara McClure Vol#: 13

C 201 Gene & Catherine McConnachie Vol#: 13

C 202 Lynn Kropp Vol#: 13

C 203 Debra Glelich Vol#: 13

C 204 James E Stewart Vol#: 13

C 205 Mary Jo Smith Vol#: 13

C 206 Joyce H Lewis Vol#: 13

C 207 Bev Mullins Vol#: 13

C 208 Alex Silverio Vol#: 13

EMC 353 Lisa Sheldon Vol#: 12

EMC 354 Janet Shaffer Vol#: 12

00P-1486 ANADA Suitability Petition for a Generic Oral Ivermectin

PDN 1 HFV-100 to Equi Aid Products, Inc Vol#: 1

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

PAV 1 HFD-600 to R & R Registrations Vol#: 1

00P-1594 ANADA for Invermectin

PDN 1 HFV-100 to Shotwell & Carr, Inc. Vol#: 1

00P-1600 ANADA Suitability for Ivermectin

PDN 1 HFV-100 to SciReg, Inc. Vol#: 1

01D-0194 Statistical Aspects Design,Analysis,Interpretation,chronic

C 2 Hugh E. Black & Associates, Inc. Vol#: 1

01D-0274 Laser Products

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

01H-0065 Civil Money Penalty for First Check Home Drug Test Decives

CS 5 HFA-305 Vol#: 1

CS 6 HFA-305 Vol#: 1

OR 4 HF-3 Vol#: 1

OR 5 HF-3 Vol#: 1

01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC

C 198 Timothy Hawkins Vol#: 10

C 199 Becky Vol#: 10

C 200 Lisa Decker Vol#: 10

C 201 Elizabeth Eberts Vol#: 10

C 202 James B. Corbett, M.D. Vol#: 10

C 203 Ruth Fransen Vol#: 10

C 204 Mr. Mark Hanschka, M.D. Vol#: 10

C 205 Ms. Cynthia Curran-Vanier Vol#: 10

C 206 Mr. Perry Haymes Vol#: 10

C 207 Mr. Victor Feigelman Vol#: 10

C 208 Ms. Burnice Kraemer Vol#: 10

C 209 Dr. Frances Kahn Vol#: 10

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 149 illegible Vol#: 9

01V-0328 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Stim-U-Lights Vol#: 1

01V-0330

ACK 1 HFA-305 Vol#: 1

VAR 1 The Grid Vol#: 1

01V-0331

ACK 1 HFA-305 Vol#: 1

VAR 1 Platinum, Inc./Streeters Vol#: 1

01V-0332

ACK 1 HFA-305 Vol#: 1

VAR 1 Quasar Productions Vol#: 1