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 24, 2001

TABLE OF CONTENTS

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00D-1598 Voluntary Labeling for Bioengineered Foods *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-1472 Over-the-counter sodium phosphate bowel preparation products *

95P-0315 Reclassify Automated Differential Cell Counting Devices

NCR 1 Vol#: 2

99V-0185 Variance Laser Light Show LT-1000

ACK 2 HFA-305 Vol#: 1

CR 1 HFA-305 Vol#: 1

EXP 1 Nu-Salt Laser Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

C 5545 Linda Johns Vol#: 368

C 5546 Sheila Heckman Vol#: 368

C 5547 Andrea K. Hills Vol#: 368

C 5548 Paul J. Johnson Vol#: 368

C 5549 Edith J. Gillis Vol#: 368

C 5550 Amy Satterland Vol#: 368

C 5551 Derrick J. Travers Vol#: 368

C 5552 Monika DeBrakedeer Vol#: 368

C 5553 Mary Lou Emerson Vol#: 368

C 5554 Emily Katz Vol#: 368

C 5555 Jory Aronson Vol#: 368

C 5556 Dyann Alkire Vol#: 368

C 5557 Giovanna Tarantino Vol#: 368

C 5558 Rhobert Cotton Vol#: 368

C 5559 JoAnne Knowles Vol#: 368

C 5560 Jalerie Madison Vol#: 368

C 5561 Julie R. Wright Vol#: 368

C 5562 Elaine Grogan Vol#: 368

C 5563 Colleen R. Fleming Vol#: 368

C 5564 Hans Frederick Vol#: 368

C 5565 Richard Oden Vol#: 368

C 5566 Sharon E. Streeter Vol#: 368

C 5567 Tanya Luethe Vol#: 368

C 5568 Becky Talyn Vol#: 368

C 5569 Diana Starrett Vol#: 368

C 5570 Julie Thielges Vol#: 368

C 5571 Palma Richardson Vol#: 368

C 5572 James A. Noonan Vol#: 368

C 5573 Dorothea Kryseirk Vol#: 368

C 5574 Brett Amy Thelen Vol#: 368

C 5575 Dell Goldsmith Vol#: 368

C 5576 Flora Ham Vol#: 403

C 5577 Laurie Gilmer Vol#: 403

C 5578 Avril E. Munrid Vol#: 403

C 5579 Nureet Carmel Vol#: 403

C 5580 Misti Tilford Vol#: 403

C 5581 Sam Allen Vol#: 403

C 5582 Leanne Tingley Vol#: 403

C 5583 Eligible Vol#: 403

C 5584 Harry Shaich Vol#: 403

C 5585 Earla Cummings Vol#: 403

C 5586 Rick Kumge Vol#: 403

C 5587 Merry Beth Ameine Vol#: 403

C 5588 Mary B. Middleton Vol#: 403

C 5589 Eligible Vol#: 403

C 5590 Sheila Strachan Vol#: 403

C 5591 Peter Gutmann Vol#: 403

C 5592 Rita Flygan Vol#: 403

C 5593 Phyllis P. Kirk Vol#: 403

C 5594 Chris Bissonnette Vol#: 403

C 5595 Ann Kemler Vol#: 403

C 5596 Jane E. Jewell-Vitaue Vol#: 403

C 5597 Elaine Gordan Vol#: 403

C 5598 Susan Ross Vol#: 403

C 5599 Nancy L. Navarra Vol#: 403

C 5600 The Minnis Family Vol#: 403

C 5601 Sophie Palla Vol#: 403

C 5602 Frances W. Field Vol#: 403

C 5603 Clarita H. Bright Vol#: 403

C 5604 Margo Glicksman Vol#: 403

C 5605 Michele Chalier Vol#: 403

C 5606 Gretchen Hofer Vol#: 403

C 5607 Caitlin Stewart Vol#: 403

C 5608 Paul W. Elder Vol#: 403

C 5609 Anne Pearson Vol#: 403

C 5610 Marshall & Barbara LaCombe Vol#: 403

C 5611 Willa Embry Vol#: 403

C 5612 Rick Simkin Vol#: 403

C 5613 Mr & Mrs Clifford Stoff Vol#: 403

C 5614 Gregory Gasaway Vol#: 403

C 5615 Greffrey Robert Golub Vol#: 404

C 5616 Sherrile Wilson Vol#: 404

C 5617 F. Millstein Vol#: 404

C 5618 Ngoie Lubira Vol#: 404

C 5619 Karen Fort Vol#: 404

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 6724 D. Banchead Vol#: 249

C 6725 Jessica Blorzynsi Vol#: 249

C 6726 V.H. Sorge Vol#: 249

C 6727 unreadable Vol#: 249

C 6728 Tawnya Pharis Vol#: 249

C 6729 L. Davenport Vol#: 249

C 6730 Rachel Drechsel Vol#: 249

C 6731 Fran Boeger Vol#: 249

C 6732 Katye Long Vol#: 249

C 6733 Flora Ham Vol#: 258

C 6734 Form Letter Count 14 Vol#: 259

C 6735 Form Letter Count 7 Vol#: 260

C 6736 Evelyn V. Knazek Vol#: 258

C 6737 Florence Burghorn Vol#: 258

C 6738 R. W. Blitz Vol#: 258

C 6739 Virginia Schulman Vol#: 258

C 6740 Louise S. Ransom Vol#: 258

C 6741 Andrea M. Crews Vol#: 258

C 6742 Walter Nielson Vol#: 258

C 6743 Lydia Murray Vol#: 258

C 6744 Frank Dawson Vol#: 258

C 6745 Marie Zerr Vol#: 258

C 6746 Lee Celano Vol#: 258

C 6747 Scott Deckler Vol#: 258

C 6748 Christopher Malley Vol#: 258

C 6749 Janice Forsberg Vol#: 258

C 6750 Mary-Ann Wiesemann-Mills, OP Vol#: 258

C 6751 Sara R. Wynne Vol#: 258

C 6752 Sister Elaine Eggert, O.P. Vol#: 258

C 6753 Dorothy Mattingly Vol#: 258

C 6754 Jill A. Wilcox Vol#: 258

C 6755 Patricia Regensburger Vol#: 258

C 6756 Will Newman II Vol#: 258

C 6757 Susan Bolen Vol#: 258

C 6758 Katherine Jain Vol#: 258

C 6759 Jeffrey Briar Vol#: 258

C 6760 Sarah Goldbaum Vol#: 258

EMC 9001 Kevin Cosgrove Vol#: 256

EMC 9002 Nancy Gillam Vol#: 256

EMC 9003 Daniel Costello Vol#: 256

EMC 9004 D. Dellota Vol#: 256

EMC 9005 Jill Strube Vol#: 256

EMC 9006 Maryann Roby Vol#: 256

EMC 9007 Maryann Roby Vol#: 256

EMC 9008 Stefanie Bruninghaus Vol#: 256

EMC 9009 Rowena Zuniga Vol#: 256

EMC 9010 Mariette Olsen Vol#: 256

EMC 9011 Lorraine Redig Vol#: 256

EMC 9012 Kathryn E. Spann Vol#: 256

EMC 9013 Cynthia Chovan Vol#: 256

EMC 9014 Fendi Koto Vol#: 256

EMC 9015 Matthew Joseph & Richard Stephens Vol#: 256

EMC 9016 Darryl Henriques Vol#: 256

EMC 9017 Melisa Whigham Vol#: 256

EMC 9018 Melisa Whigham Vol#: 256

EMC 9019 Lisa Frey Vol#: 256

EMC 9020 Lisa Frey Vol#: 256

EMC 9021 Katherine Button Vol#: 256

EMC 9022 no signature Vol#: 256

EMC 9023 Adrienne Coughlin Vol#: 256

EMC 9024 Ayfer Demirayak Vol#: 256

EMC 9025 Ayfer Demirayak Vol#: 256

EMC 9026 Marion Henshaw Vol#: 256

EMC 9027 Noelle Dobson Vol#: 256

EMC 9028 Shawn Dwyer Vol#: 256

EMC 9029 Shawn Dwyer Vol#: 256

EMC 9030 Debra Cash Vol#: 256

EMC 9031 Debra Cash Vol#: 256

EMC 9032 Keyeland R. Janssen Vol#: 256

EMC 9033 Ann Hand Vol#: 256

EMC 9034 Chad Dubrul Vol#: 256

EMC 9035 Kevin Suggitt Vol#: 256

EMC 9036 Devin A. Mikles Vol#: 256

EMC 9037 Dave Aul Vol#: 256

EMC 9038 Alisa Roost Vol#: 256

EMC 9039 Alisa Roost Vol#: 256

EMC 9040 Mary Ann Rocco Vol#: 256

EMC 9041 J.H. Browne, Jr. Vol#: 256

EMC 9042 Jonathan Strong Vol#: 256

EMC 9043 Jonathan Strong Vol#: 256

EMC 9044 Blair Campbell Vol#: 256

EMC 9045 Blair Campbell Vol#:

EMC 9046 Julia Whyde Vol#: 256

EMC 9047 Julia Whyde Vol#: 256

EMC 9048 Sandy Leech Vol#: 256

EMC 9049 Sharon Butler Vol#: 256

EMC 9050 Rose Laessig Vol#: 256

EMC 9051 Rose Laessig Vol#: 256

EMC 9052 Tracy & Roop Verma Vol#: 256

EMC 9053 Howard Huggins Vol#: 256

EMC 9054 Howard Huggins Vol#: 256

EMC 9055 Joni Raskin & Nicolas Fredricks Vol#: 256

EMC 9056 Richard Gilbert Vol#: 256

EMC 9057 Richard Gilbert Vol#: 256

EMC 9058 Brad Stafford Vol#: 256

EMC 9059 Dan Pasley Vol#: 256

EMC 9060 Dan Pasley Vol#: 256

EMC 9061 Dan Teoli Vol#: 256

EMC 9062 Dan Teoli, Jr. Vol#: 256

EMC 9063 James Woolery, MD Vol#: 256

EMC 9064 James Woolery, MD Vol#: 256

EMC 9065 Maggie Jordan Vol#: 256

EMC 9066 number not used Vol#: 256

EMC 9067 number not used Vol#: 256

EMC 9068 Joan Gibson Vol#: 256

EMC 9069 Joan Gibson Vol#: 256

EMC 9070 Lauren Sullivan Vol#: 256

EMC 9071 Lauren Sullivan Vol#: 256

EMC 9072 Thomas Macon Vol#: 256

EMC 9073 Rebecca Puralewski Vol#: 256

EMC 9074 Stephanie Younger Vol#: 256

EMC 9075 Sarah Pope Vol#: 256

EMC 9076 Fred Lazare Vol#: 256

EMC 9077 Fred Lazare Vol#: 256

EMC 9078 Jim Molnar Vol#: 256

EMC 9079 Jim Molnar Vol#: 256

EMC 9080 David Pippin Vol#: 256

EMC 9081 Pandra Fredricksen Vol#: 256

EMC 9082 Diane Mellen Vol#: 256

EMC 9083 Diane Mellen Vol#: 256

EMC 9084 Jill Sheinberg Vol#: 256

EMC 9085 Jill Sheinberg Vol#: 256

EMC 9086 C. Jameson Wells Vol#: 256

EMC 9087 Emily Draws Vol#: 256

EMC 9088 Emily Draws Vol#: 256

EMC 9089 Richard Baynton Vol#: 256

EMC 9090 Richard Baynton Vol#: 256

EMC 9091 Julia MacBrien Vol#: 256

EMC 9092 Julia MacBrien Vol#:

EMC 9093 Mary Altmann Vol#: 256

EMC 9094 Mary Altmann Vol#: 256

EMC 9095 Carl Wright Vol#: 256

EMC 9096 Carl Wright Vol#: 256

EMC 9097 Jon Koppenhoefer Vol#: 256

EMC 9098 Jon Koppenhoefer Vol#: 256

EMC 9099 Critt Spurlin Vol#: 256

EMC 9100 Critt Spurlin Vol#: 256

EMC 9101 Caroline Spintzyk Vol#: 256

EMC 9102 Frank Chisholm Vol#: 256

EMC 9103 Frank Chisholm Vol#: 256

EMC 9104 Sally Mackle Vol#: 256

EMC 9105 Sally Mackle Vol#: 256

EMC 9106 Sharon Madison Vol#: 256

EMC 9107 Judith Detert-Moriarty Vol#: 256

EMC 9108 Jim Ross Vol#: 256

EMC 9109 Jim Ross Vol#: 256

EMC 9110 Jessica Almy Vol#: 256

EMC 9111 number not used Vol#: 256

EMC 9112 James Bradach Vol#: 256

EMC 9113 James Bradach Vol#: 256

EMC 9114 Eric Benvenue-Jennings Vol#: 256

EMC 9115 Eric Benvenue-Jennings Vol#: 256

EMC 9116 Bill Grigsby Vol#: 256

EMC 9117 Bill Grigsby Vol#: 256

EMC 9118 Erin Needham Vol#: 256

EMC 9119 Erin Needham Vol#: 256

EMC 9120 Kathy Bacon Vol#: 256

EMC 9121 Kathy Bacon Vol#: 256

EMC 9122 Sandra White Vol#: 256

EMC 9123 Sandra White Vol#: 256

EMC 9124 Jean Connell Vol#: 256

EMC 9125 Jean Connell Vol#: 256

EMC 9126 Danny Lufkin Vol#: 256

EMC 9127 Megan Galbraith Vol#: 256

EMC 9128 Megan Galbraith Vol#: 256

EMC 9129 Danny Lufkin Vol#: 256

EMC 9130 Douglas Hawes Vol#: 256

EMC 9131 Douglas Hawes Vol#: 256

EMC 9132 James M. Draws,Sr. Vol#: 256

EMC 9133 James M. Draws, Sr. Vol#: 256

EMC 9134 Mayra Acevedo Vol#: 256

EMC 9135 Bill Farley Vol#: 256

EMC 9136 Bill Farley Vol#: 256

EMC 9137 Thomas LeGrand Vol#: 256

EMC 9138 Thomas LeGrand Vol#: 256

EMC 9139 Heather Manis Vol#: 256

EMC 9140 Heather Manis Vol#: 256

EMC 9141 Rev. Jimmye Kimmey Vol#: 256

EMC 9142 Rev. Jimmye Kimmey Vol#: 256

EMC 9143 David Kleinman Vol#: 256

EMC 9144 David Kleinman Vol#: 256

EMC 9145 Marilyn Higginson Vol#: 256

EMC 9146 Marilyn Higginson Vol#: 256

EMC 9147 Jeffrey Kirk Vol#: 256

EMC 9148 Jeffrey Kirk Vol#: 256

EMC 9149 Marylisa Gavenas Vol#: 256

EMC 9150 Marylisa Gavenas Vol#: 256

EMC 9151 Daisy Asperdasper Vol#: 256

EMC 9152 Ralf Brand Vol#: 256

EMC 9153 Daniel McCoy Vol#: 256

EMC 9154 number not used Vol#: 256

EMC 9155 Deb Sgambelluri Vol#: 256

EMC 9156 Deb Sgambelluri Vol#: 256

EMC 9157 Scott Patten Vol#: 256

EMC 9158 Scott Patten Vol#: 256

EMC 9159 Marcy Wheeler Vol#: 256

EMC 9160 Marcy Wheeler Vol#: 256

EMC 9161 Margil Willowmoon Vol#: 256

EMC 9162 Margil Willowmoon Vol#: 256

EMC 9163 Max Peterson Vol#: 256

EMC 9164 Elliot Wisotsky Vol#: 256

EMC 9165 Elliot Wisotsky Vol#: 256

EMC 9166 Daniel Bergman Vol#: 256

EMC 9167 Daniel Bergman Vol#: 256

EMC 9168 Wilhelm Welzenbach Vol#: 256

EMC 9169 Wilhelm Welzenbach Vol#: 256

EMC 9170 Frances Farrell Vol#: 256

EMC 9171 Frances Farrell Vol#: 256

EMC 9172 Pete Hallenberg Vol#: 256

EMC 9173 Pete Hallenberg Vol#: 256

EMC 9174 Danielle Littenberg Vol#: 256

EMC 9175 Danielle Luttenberg Vol#: 256

EMC 9176 Stephen Grant Vol#: 256

EMC 9177 Stephen Grant Vol#: 256

EMC 9178 Evan Serfass Vol#: 256

EMC 9179 Evan Serfass Vol#: 256

EMC 9180 Kai Robertson Vol#: 256

EMC 9181 Katie McCarthy Vol#: 256

EMC 9182 Katie McCarthy Vol#: 256

EMC 9183 Matthew Carter Vol#: 256

EMC 9184 Matthew Carter Vol#: 256

EMC 9185 Sharon Smith Vol#: 256

EMC 9186 Peter Carosella Vol#: 256

EMC 9187 Janet Walker Vol#: 256

EMC 9188 Jennifer McEwen Vol#: 256

EMC 9189 Laura Stinson Vol#: 256

EMC 9190 Laura Stinson Vol#: 256

EMC 9191 Barbara Power Vol#: 256

EMC 9192 Barbara Power Vol#: 256

EMC 9193 Wayne Phillips Vol#: 256

EMC 9194 Wayne Phillips Vol#: 256

EMC 9195 Phil Hamilton Vol#: 256

EMC 9196 Phil Hamilton Vol#: 256

EMC 9197 Gregory Campbell Vol#: 256

EMC 9198 Gregory Campbell Vol#: 256

EMC 9199 Karen Bauer Vol#: 256

EMC 9200 Karen Bauer Vol#: 256

EMC 9201 Linda Osborn Vol#: 257

EMC 9202 Linda Osborn Vol#: 257

EMC 9203 Russ Bulluck Vol#: 257

EMC 9204 Russ Bulluck Vol#: 257

EMC 9205 Sean Quinn Vol#: 257

EMC 9206 Carolyn Smith Vol#: 257

EMC 9207 Carolyn Smith Vol#: 257

EMC 9208 Erin Raskin Vol#: 257

EMC 9209 Philip H. Coe Vol#: 257

EMC 9210 Philip H. Coe Vol#: 257

EMC 9211 Tori Jo Wible Vol#: 257

EMC 9212 Tori Jo Wible Vol#: 257

EMC 9213 number not used Vol#: 257

EMC 9214 Suzanne Meyer Vol#: 257

EMC 9215 Fred Brock Vol#: 257

EMC 9216 Fred Brock Vol#: 257

EMC 9217 Kelly Cowan Vol#: 257

EMC 9218 Mary Pitts Vol#: 257

EMC 9219 Mary Pitts Vol#: 257

EMC 9220 Joanne McVicker Vol#: 257

EMC 9221 Amy Zezulka Vol#: 257

EMC 9222 Roberta Dunderdale Vol#: 257

EMC 9223 James Ehrlich Vol#: 257

EMC 9224 Christopher Robertson Vol#: 257

EMC 9225 Christopher Robertson Vol#: 257

EMC 9226 Randall L. Wolf Vol#: 257

EMC 9227 Jacquie Olsen Vol#: 257

EMC 9228 Ovadia Yesodi Vol#: 257

EMC 9229 Ovadia Yesodi Vol#: 257

EMC 9230 Karen Olch Vol#: 257

EMC 9231 Karen Olch Vol#: 257

EMC 9232 Cecily Andrews Vol#: 257

EMC 9233 Cecily Andrews Vol#: 257

EMC 9234 Debora Goldstein Vol#: 257

EMC 9235 Debora Goldstein Vol#: 257

EMC 9236 Theola Medley, Jr. Vol#: 257

EMC 9237 Gregory Campbell Vol#: 257

EMC 9238 Elizabeth Croteau Vol#: 257

EMC 9239 Elizabeth Croteau Vol#: 257

EMC 9240 Elvira Niles Vol#: 257

EMC 9241 Elvira Niles Vol#: 257

EMC 9242 Richard Bischoff Vol#: 257

EMC 9243 Richard Bischoff Vol#: 257

EMC 9244 Irl Nelson Stalcup Vol#: 257

EMC 9245 Irl Nelson Stalcup Vol#: 257

EMC 9246 number not used Vol#: 257

EMC 9247 number not used Vol#: 257

EMC 9248 Steven Landau Vol#: 257

EMC 9249 Steven Landau Vol#: 257

EMC 9250 Michael Benowich Vol#: 257

EMC 9251 Michael Benowich Vol#: 257

EMC 9252 Steve Cater Vol#: 257

EMC 9253 Fred Schneider Vol#: 257

EMC 9254 Fred Schneider Vol#: 257

EMC 9255 Rebekah Leonhart Vol#: 257

EMC 9256 Rebekah Leonhart Vol#: 257

EMC 9257 Jennifer Maloney Vol#: 257

EMC 9258 Gus Steeves Vol#: 257

EMC 9259 Gus Steeves Vol#: 257

EMC 9260 Samantha Wanat Vol#: 257

EMC 9261 Samantha Wanat Vol#: 257

EMC 9262 Ivars Ikstrums Vol#: 257

EMC 9263 Peggy Swsweeney Vol#: 257

EMC 9264 Peggy Swsweeney Vol#: 257

EMC 9265 Carrie Gorr Vol#: 257

EMC 9266 Carrie Gorr Vol#: 257

EMC 9267 Christopher Martinez Vol#: 257

EMC 9268 Anne Eller Vol#: 257

EMC 9269 Anne Eller Vol#: 257

EMC 9270 Lynn Leeds Vol#: 257

EMC 9271 number not used Vol#: 257

EMC 9272 number not used Vol#: 257

EMC 9273 number not used Vol#: 257

EMC 9274 Duke Mangione Vol#: 257

EMC 9275 Duke Mangione Vol#: 257

EMC 9276 Carolina Brock Vol#: 257

EMC 9277 Patricia Morris Vol#: 257

EMC 9278 Ruth Kearley Vol#: 257

EMC 9279 Ruth Kearley Vol#: 257

EMC 9280 Jon Shay Vol#: 257

EMC 9281 Linda Conners Vol#: 257

EMC 9282 Averie Clark Vol#: 257

EMC 9283 Lee Hettema Vol#: 257

EMC 9284 Ralph Fubar Vol#: 257

EMC 9285 Anne Shudy Vol#: 257

EMC 9286 Anne Shudy Vol#: 257

EMC 9287 Tim & Sue Hess Vol#: 257

EMC 9288 Tim & Sue Hess Vol#: 257

EMC 9289 Rev. Frank Jude Boccio Vol#: 257

EMC 9290 Sherrie Marchi Vol#: 257

EMC 9291 Kay Gartrell Vol#: 257

EMC 9292 Kay Gartrell Vol#: 257

EMC 9293 Adam Polakoff Vol#: 257

EMC 9294 Lori Benton Vol#: 257

EMC 9295 Lori Benton Vol#: 257

EMC 9296 Richard Kover Vol#: 257

00P-1472 Over-the-counter sodium phosphate bowel preparation products

PDN 1 HFC-1 to Kleinfeld, Kaplan & Becker Vol#: 2

01M-0210 P000035;TMJ Fossa-Eminence Prosthesis

CR 1 TMJ Implants, Inc. Vol#: 1

01M-0305 VISX STAR Excimer Laser System, Models S2 & S3, P930016/s12

AAV 1 Visx Inc Vol#: 1

01M-0306 RapidScreen RS-2000, P000041

AAV 1 Deus Technologies Vol#: 1

01M-0307 AquaFlow Collagen Glaucoma Drainage Device, Model CGDD-20

AAV 1 Starr Surgical Company Vol#: 1

01M-0309 KERACOR 116 Ophthalmic Excimer Laser System (16 Units)

AAV 1 Bausch & Lomb Surgical Vol#: 1

01M-0310 Dimension RxL PSA Reagent Cartridge, P000021

AAV 1 Dade Behring Inc Vol#: 1

01V-0237 Laser Light Show

M 1 HFZ-342 Vol#: 1