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 31, 2001

TABLE OF CONTENTS

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

NOTE:  Documents received by the Dockets Management Branch "MAY" be posted on the Internet. PLEASE DO NOT  include personal identifying information, i.e. date of birth, social security number, etc., in your correspondence.

[FDA DOCKETS PAGE] [FDA HOME PAGE]  [ ITEM CODES ]

 
78N-0301 OTC External Analgesic Drug Products *
78N-036L OTC Laxative *
82D-0322 MONITORING CLINICAL INVESTIGATIONS;AVAILABILITY GUIDELINE *
93P-0310 White Chocolate Deviating From Identity Standard; TPMT *
97N-0497 Allogeneic Peripheral and Placental/ Umbilical Cord Blood *
98N-1038 Irradiation in the production, processing, &handling of food *
00D-1598 Voluntary Labeling for Bioengineered Foods *
01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC *
01P-0230 Domestic Marketing & Importation of Transgenic Fish *
78N-0301 OTC External Analgesic Drug Products

SUP 9 Marvin Rapaport, M.D. Vol#: 102

SUP 10 Marvin Rapaport, M.D. Vol#: 102

SUP 11 Marvin Rapaport, M.D. Vol#: 102

78N-036L OTC Laxative

LET 194 Chester Labs Vol#: 107

82D-0322 MONITORING CLINICAL INVESTIGATIONS;AVAILABILITY GUIDELINE

ANS 2 HfD-45 to Kendle International BV Vol#: 1

93P-0310 White Chocolate Deviating From Identity Standard; TPMT

LET 98 Parmalat Canada Bakery Division Vol#: 2

97N-0497 Allogeneic Peripheral and Placental/ Umbilical Cord Blood

C 13 Thermogenesis Corp Vol#: 4

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

C 29 Animal Health Institute Vol#: 16

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

C 175 Robert J Warren Vol#: 21

98N-1038 Irradiation in the production, processing, &handling of food

C 5457 Shirley J. Marshall Vol#: 169

C 5458 Dolores G. Meck Vol#: 169

C 5459 David H. Jones Vol#: 169

C 5460 Joseph M. Stern Vol#: 169

C 5461 Jay Albrecht, Ph.D. Vol#: 169

C 5462 Harry Browne Vol#: 169

C 5463 Rich Yurman Vol#: 169

C 5464 Leonore Arvidson Vol#: 169

C 5465 Robert M. Donner Vol#: 169

C 5466 Frank Maverick Vol#: 169

C 5467 David J. Lebowitz Vol#: 169

C 5468 Ms. Aimee Lykes Vol#: 169

C 5469 Gardens of the Goddess Vol#: 169

C 5470 Form letters count 7 Vol#: 171

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9035 Mary Lehmer Vol#: 462

C 9036 Wilson Diehl Vol#: 462

C 9037 Susan Maxweu Vol#: 462

C 9038 Judith Clinton Vol#: 462

C 9039 Casey Kohrt Vol#: 462

C 9040 Carol Adderley Vol#: 462

C 9041 Diana Thorn Vol#: 462

C 9042 Michael J. Santangelo Vol#: 462

C 9043 Candida Maurer Vol#: 462

C 9044 Susannah Copi Vol#: 462

C 9045 Laura Secrest Vol#: 462

C 9046 Harriet Johnson-O'Mara Vol#: 462

C 9047 Heidi Telepner Vol#: 462

C 9048 Monika Schleicher Martin Vol#: 462

C 9049 Robert D. Foster Vol#: 462

C 9050 Susel Fagan Vol#: 462

C 9051 Suzanne Araas Vesely Vol#: 463

C 9052 Joyce A. Marner Vol#: 463

C 9053 Wayne Henderson Vol#: 463

C 9054 Martha Sieber Vol#: 463

C 9055 Emily Sieba Vol#: 463

C 9056 Steve Marsden Vol#: 463

C 9057 Nancy Schneider Vol#: 463

C 9058 No signature Vol#: 463

C 9059 Henry Milczek Vol#: 463

C 9060 Monika Colton Vol#: 463

C 9061 Harris Vol#: 463

C 9062 James E. Danies, Jr. Vol#: 463

C 9063 Eva M. Ciabattoni Vol#: 463

C 9064 Rachelle Bell Vol#: 463

C 9065 Craig Rice Vol#: 463

C 9066 Celia Scott Vol#: 463

C 9067 Jon Wittwer Vol#: 463

C 9068 Erin Hillier Vol#: 463

C 9069 D. Eisenstein Vol#: 463

C 9070 Paula Cohn Vol#: 463

C 9071 Lefty & Nancy Martin Vol#: 463

C 9072 Dorothy Geisler Vol#: 463

C 9073 John Burke Vol#: 463

C 9074 Carmen K. McElwee Vol#: 463

C 9075 Ingelore & Ernest Weinberg Vol#: 463

C 9076 Ann Russell Vol#: 463

C 9077 Helen Campbell Vol#: 463

C 9078 Helen Blanding Vol#: 463

C 9079 Talley Mezzanatto Vol#: 463

C 9080 Mary Goodwin Vol#: 463

C 9081 Doris Grinn Vol#: 463

C 9082 Douglass Perske Vol#: 463

C 9083 Teresa Dixon Vol#: 463

C 9084 Gretchen Glad Taylor Vol#: 463

C 9085 Colleen Whalen Vol#: 463

C 9086 S.J. Hork Vol#: 463

C 9087 Virginia Sweet Vol#: 463

C 9088 Sherman Stein Vol#: 463

C 9089 Michael Lamperd Vol#: 463

C 9090 Sharon Pokas Vol#: 463

C 9091 Christina Crumpton Vol#: 463

C 9092 William Riesenberger Vol#: 463

C 9093 Mookie Fudemberg Vol#: 463

C 9094 Mookie Fudemberg Vol#: 463

C 9095 Nancy Luffey Vol#: 463

C 9096 Jennifer Vance Vol#: 463

C 9097 Kati Brazda Vol#: 463

C 9098 Michele R. Braley Vol#: 463

C 9099 Mark Feblowitz Vol#: 463

C 9100 Sophie Fleming Vol#: 463

C 9101 Rena Nayyar Vol#: 463

C 9102 Reba Johnson Vol#: 463

C 9103 Eligible Vol#: 463

C 9104 Jean Ito Vol#: 463

C 9105 Thomas Browne Vol#: 463

C 9106 Judith Bell & Daniel Ellenburg Vol#: 463

C 9107 Suzi Weu Vol#: 463

C 9108 Jeannette Muzima Vol#: 463

C 9109 Douglas Winsor Vol#: 463

C 9110 Klara M. Droessler Vol#: 463

C 9111 Marilyn Garrett Vol#: 463

C 9112 Ray H. Katz Vol#: 463

C 9113 June Maselbas Vol#: 463

C 9114 Mae S. Harms Vol#: 463

C 9115 Judy B. Low Vol#: 463

C 9116 Marion E. Wadesworth Vol#: 463

C 9117 Sharon M. Kilgore Vol#: 463

C 9118 N.W. Ruhm Vol#: 463

C 9119 Teresa Dunn Vol#: 463

C 9120 Nancy Nitsch Vol#: 463

C 9121 Julie Kandenwal Vol#: 463

C 9122 Joan Jordan Vol#: 463

C 9123 Wendy Micici Vol#: 463

C 9124 Janet Croin Vol#: 463

C 9125 Donna Cotner Vol#: 463

C 9126 Ilona I. Marshall Vol#: 463

C 9127 Tracey Martin Vol#: 463

C 9128 Susan Jeffrey Vol#: 463

C 9129 Bob A. Busby & Maureen Conte Vol#: 463

C 9130 Ilyse Simon Vol#: 463

C 9131 Michael Spivak Vol#: 463

C 9132 Dianne Mahler Vol#: 463

C 9133 A. Ann Pulley Vol#: 463

C 9134 Charlotte Stark Vol#: 463

C 9135 Carol Deangelis Vol#: 463

C 9136 Connie Sing Vol#: 463

C 9137 Bonnie E. Kendrich Vol#: 463

C 9138 Kristina Turner Vol#: 463

C 9139 John B. Gallagher Vol#: 463

C 9140 Jan Brandenburg Vol#: 463

C 9141 Mary Jane Daughenbaugh Vol#: 463

C 9142 Stacey London Vol#: 463

C 9143 Larry Sugisaki Vol#: 463

C 9144 Lisha Doucet Vol#: 463

C 9145 Brittany Ridley Vol#: 463

C 9146 Sofia Zander Vol#: 463

C 9147 D.J. DeMott Vol#: 463

C 9148 Kathleen M. Searl Vol#: 463

C 9149 David Anderson Vol#: 463

C 9150 Dona Meyer Vol#: 463

C 9151 Mildred M. Paris Vol#: 463

C 9152 Bonnie J. Gregley Vol#: 463

C 9153 Jay Finneburgh Vol#: 463

C 9154 Linon Sherman Vol#: 463

C 9155 Judy Owsowitz Vol#: 463

C 9156 Ann Rozabia Szabo Vol#: 463

C 9157 Donald Nofziger Vol#: 463

C 9158 Emily Macchione Vol#: 463

C 9159 Susanna Waiche Vol#: 463

C 9160 Jennifer Ryan Vol#: 463

C 9161 Dean & Fran Stegmann Vol#: 463

C 9162 Lisa Guttormsson Vol#: 463

C 9163 Caroline Seckinger Vol#: 463

C 9164 Alicia Vere Vol#: 463

C 9165 Paul A. Janowitz Vol#: 463

C 9166 Marty L.R. Kovacs Vol#: 463

C 9167 Pandora Ponter Mitchell Vol#: 463

C 9168 B.R. Guillory Vol#: 463

C 9169 Brooke Abdelnoor Vol#: 463

C 9170 Andrea Kiepe Vol#: 463

C 9171 Barbara DeGregoria, PhD Vol#: 463

C 9172 Rita Robison Vol#: 463

C 9173 Cindy Haida-Banks Vol#: 463

C 9174 Julie Matthaei Vol#: 463

C 9175 Gaetano Vol#: 463

C 9176 Ruth Burch Vol#: 463

C 9177 Misha Ranchmerger Vol#: 463

C 9178 Peter Kavanaugh Vol#: 463

C 9179 Renee A. Nastri-Windisch Vol#: 463

C 9180 Brenda L. Caldwell Vol#: 463

C 9181 David McMuller Vol#: 463

C 9182 M.G. Allison Vol#: 463

C 9183 Charles A. Joseph Vol#: 463

C 9184 Christina L. Bosch Vol#: 463

C 9185 Patricia M. Spence Vol#: 463

C 9186 Jim Swoish Vol#: 463

C 9187 Davan Deasen Vol#: 463

C 9188 Laurie Fine Vol#: 463

C 9189 T. Scali Vol#: 463

C 9190 Trudy Kelly Vol#: 463

C 9191 Sylvia Van Peuson Vol#: 463

C 9192 Kelly Lubeck Vol#: 463

C 9193 Ruth Eggering Vol#: 463

C 9194 Eva Macki Vol#: 463

C 9195 Gael Dusken Vol#: 463

C 9196 Catherine Williams Vol#: 463

C 9197 Arlene Montgomery Vol#: 463

C 9198 Sue Miller Vol#: 463

C 9199 Kelly Green Vol#: 463

C 9200 Alice Ordway Vol#: 463

C 9201 Doris Lloyd Vol#: 464

C 9202 Laurie Schultz Vol#: 464

C 9203 Marion Sweeney Vol#: 464

C 9204 Gael Dusken Vol#: 464

C 9205 No signature Vol#: 464

C 9206 Eyleen Hawkins Vol#: 464

C 9207 Carla Kallan Vol#: 464

C 9208 Roberta Rigsby Vol#: 464

C 9209 Pat Dennstedt Vol#: 464

C 9210 L. Schwartzman Vol#: 464

C 9211 Ted Rowell Vol#: 464

C 9212 Carol Cochella Vol#: 464

C 9213 Virginia Hammer Vol#: 464

C 9214 Charles Jamieson Vol#: 464

C 9215 Annie Wyndham Vol#: 464

C 9216 Grace Saviders-Dodis Vol#: 464

C 9217 Grace Saviders-Dodis Vol#: 464

C 9218 Cheryl McEntire Vol#: 464

C 9219 Noelle Ostrom Vol#: 464

C 9220 Greer Stangl Vol#: 464

C 9221 Maribeth Ostrander Vol#: 464

C 9222 Maria Sandoval Vol#: 464

C 9223 Dodi Ehlert, CPA Vol#: 464

C 9224 Mary Mason Felder Vol#: 464

C 9225 F.C. English Vol#: 464

C 9226 Kevin Trammel Vol#: 464

C 9227 Kate Molling Vol#: 464

C 9228 Mike Tolker Vol#: 464

C 9229 Virginia Bennett Vol#: 464

C 9230 Diane Sultan Vol#: 464

C 9231 Mary Chandra Vol#: 464

C 9232 Justin Moreephn Vol#: 464

C 9233 Marshall Ocker Vol#: 464

C 9234 Geneva Agnes Gates Vol#: 464

C 9235 Marie Koerner Vol#: 464

C 9236 David Cutler Vol#: 464

C 9237 Georgia D. Harbin Vol#: 464

C 9238 Mr. Ries Vol#: 464

C 9239 Michael Savino Vol#: 464

C 9240 Lee Preble Vol#: 464

C 9241 Carol Waide Vol#: 464

C 9242 G. Rephael Vol#: 464

C 9243 Julia Cato Vol#: 464

C 9244 Patricia M. Ballard Vol#: 464

C 9245 Y. Stumer Vol#: 464

C 9246 Shauna L. Haines Vol#: 464

C 9247 Shelly Hight Vol#: 464

C 9248 Richard H. Malcarsey, Jr Vol#: 464

C 9249 John Holden Vol#: 464

C 9250 Marilyn Madrone Vol#: 464

C 9251 Vanara Pulling Vol#: 464

C 9252 Pleasant Place Inc. Vol#: 464

C 9253 Henrietta Carter Vol#: 464

C 9254 Lorna Brown et al Vol#: 464

C 9255 Janice Nickola Vol#: 464

C 9256 Mike Narodovich Vol#: 464

C 9257 Hayden Henningsen Vol#: 464

C 9258 Timothy Krebs Vol#: 464

C 9259 Jim Kiukkont Vol#: 464

C 9260 P. Gold Vol#: 464

C 9261 Allison Lasky Vol#: 464

C 9262 Elise Miller Vol#: 464

C 9263 Liis McKena Vol#: 464

C 9264 Karen Seeman Vol#: 464

C 9265 Lawrence Leaman Vol#: 464

C 9266 Anne Labrie Vol#: 464

C 9267 Joyce Vanaher Vol#: 464

C 9268 Shannon A. Lynch Vol#: 464

C 9269 Lisa Kleiber Vol#: 464

C 9270 Nancy Lowe Vol#: 464

C 9271 Wanda Harvey Vol#: 464

C 9272 Cheryl A. Johe Vol#: 464

C 9273 John B. Collins Vol#: 464

C 9274 Betty Borg Vol#: 464

C 9275 Mellie H. Boykin Vol#: 464

C 9276 E. Fay Sheeler Vol#: 464

C 9277 Suzanne Townsend Vol#: 464

C 9278 Kaukab Ellis Vol#: 464

C 9279 Heidi Haslinger Vol#: 464

C 9280 Nicholas Frantett Vol#: 464

C 9281 Brooke T. Shell Vol#: 464

C 9282 Linda Wescott Vol#: 464

C 9283 William & Mary Hardy Vol#: 464

C 9284 Maj Nick Tolias Vol#: 464

C 9285 R. Donna-Amantia Vol#: 464

C 9286 Robert J. Haas Vol#: 464

C 9287 Alice G. Bradford Vol#: 464

C 9288 L.M. John Vol#: 464

C 9289 Christina T. Brown Vol#: 464

C 9290 June N. Clifton Vol#: 464

C 9291 Marie L. N. Reinert Vol#: 464

C 9292 Rhonda H. Smith Vol#: 464

C 9293 Jesus Leal Vol#: 464

C 9294 Emily Walhout Vol#: 464

C 9295 Albert W. Klein, M.D. Vol#: 464

C 9296 Maureen Farr Vol#: 464

C 9297 Ron Parker Vol#: 464

00P-1499 Remove alosetron (Lotronex) from the market

C 172 Arthur Davida MD Vol#: 5

C 173 Carlisle Digestive Disease Associates Lt Vol#: 5

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

CS 7 HFA-305 Vol#: 1

MO 9 GCF-1 Vol#: 1

OR 6 HF-3 Vol#: 1

01M-0371 P990026, GlucoWatch Automatic Glucose Biographer

AAV 1 Cygnus Inc Vol#: 1

01M-0373 Medtronic InSync Biventricular Pacing System

AAV 1 Medtornic Inc Vol#: 1

01N-0256 Use of Opiate Analgesics in Various Patient Population inclu

C 155 Barbara Oleksia Vol#: 6

C 156 Lisete R Borlik Vol#: 6

C 157 Howard A Heit MD Vol#: 6

C 158 SouthCoast Medical Group Vol#: 6

C 159 Nat'l Foundation for the Tteatment of Pa Vol#: 6

C 160 John Hopkins Medicine Vol#: 6

C 161 Claudy Pierce Vol#: 6

C 162 Lester Carter Vol#: 6

C 163 Elizabeth J Anderson Vol#: 6

C 164 Jorge A Martinez MD Vol#: 6

C 165 David B C Nees Vol#: 6

C 166 Center for Physical Medicine & Pain Mgmt Vol#: 6

C 167 Richard A Nelson MD Vol#: 6

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

C 218 Wendy Hrncir Vol#: 10

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 167 Erin Raffini Vol#: 9