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 1, 2001

TABLE OF CONTENTS

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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 ]

 
95S-0117 Human Drugs Patent Term Extension & New Patents *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-1322 Food Labeling and Allergen Contamination Control *
01D-0025 Guidance for Industry - Yellow Corn & Dry-Milled *
01P-0303 Petition of Declaration, Calcitek Inc *
01P-0333 Non-lyophilized Cytoxan *
01P-0334 Revoke Invalid FDA Regulations *

77N-0085 Saccharin and Its Salts

C 20697 Milton Erickson Vol#: 162

95S-0117 Human Drugs Patent Term Extension & New Patents

LST 64 List as of July 20, 2001 Vol#: 4

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

EMC 275 Rick Crotta Vol#: 42

EMC 276 Cesar Pino Vol#: 42

EMC 277 Irucka Embry Vol#: 42

EMC 278 Karen Anderson Vol#: 42

EMC 279 Kimberly A Clemens Vol#: 42

EMC 280 James M Nordlund Vol#: 42

EMC 281 Virginia Ravenscroft-Scott Vol#: 42

EMC 282 Rhonda Wilson Vol#: 42

EMC 283 Joan Newman Vol#: 42

00D-1455 Premarket Notification for Totally Implanted Spinal Cord

C 28 FORM LETTER COUNT 31 Vol#: 5

00D-1598 Voluntary Labeling for Bioengineered Foods

C 6124 Barbara Braudler Vol#: 412

C 6125 Marya A. Bradley Vol#: 412

C 6126 Tamara Ellen-Hess Shields Vol#: 412

C 6127 Paul Gitchoff Vol#: 412

C 6128 Marjory Ward Vol#: 412

C 6129 Para Winingham Vol#: 412

C 6130 Jean M. Yemm Vol#: 412

C 6131 Elena Christians Vol#: 412

C 6132 Solveia Ryall Vol#: 412

C 6133 Megan Harstead Vol#: 412

C 6134 Jeremy Noenkes Vol#: 412

C 6135 Marisa Lousier Vol#: 412

C 6136 Kathryn Ogg Vol#: 412

C 6137 Curt Kingsley Vol#: 412

C 6138 K. Stephenson Vol#: 412

C 6139 Diane Comtois Vol#: 412

C 6140 J. Wilkinson Vol#: 412

C 6141 Joanne Harrison-Gaunt Vol#: 412

C 6142 Jens Jakosbsen Vol#: 412

C 6143 Michael Russell Vol#: 412

C 6144 Stephanie Wilson Vol#: 412

C 6145 Jill DeVine Vol#: 412

C 6146 Alison Kelly Vol#: 412

C 6147 R.K. Schacht Vol#: 412

C 6148 Monka Ozwoelp Vol#: 412

C 6149 Ann Slater Vol#: 412

C 6150 Mark Cadiz Vol#: 412

C 6151 Linda Morris Vol#: 412

C 6152 Linda Kelly Vol#: 412

C 6153 Joe Ryder Vol#: 412

C 6154 D. Moore Vol#: 412

C 6155 Margi Willowmoon Vol#: 412

C 6156 Jon Ner Vol#: 412

C 6157 M. Immerman Vol#: 412

C 6158 Sharah Simms Vol#: 412

C 6159 Terri Gundelaoh Vol#: 412

C 6160 Jane Moodie Vol#: 412

C 6161 Zak Madrae Vol#: 412

C 6162 Shannon Sardell Vol#: 412

C 6163 Aaron Irons Vol#: 412

C 6164 Lisa Arkin Vol#: 412

C 6165 Nancy Hamren Vol#: 412

C 6166 Patricia Adlum Vol#: 412

C 6167 Arainea Westfall Vol#: 412

C 6168 M. Johnson Vol#: 412

C 6169 Giora Starchild Vol#: 412

C 6170 Janet Niven Vol#: 412

C 6171 Thomas Ortale Vol#: 412

C 6172 Walden Simper Vol#: 412

C 6173 Anni Killam Vol#: 412

C 6174 Mary Zorich Vol#: 412

C 6175 Michael Miller Vol#: 412

C 6176 Ellen Lowerstein Vol#: 412

C 6177 Margve Elskoe Vol#: 412

C 6178 Jonathan Giddeus Vol#: 412

C 6179 Robert Myers Vol#: 412

C 6180 Sharon Dooley Vol#: 412

C 6181 D. Hanson Vol#: 412

C 6182 Phil Huber Vol#: 412

C 6183 Ruth Kale Vol#: 412

C 6184 Eligible Vol#: 412

C 6185 Melanie Koskaus Vol#: 412

C 6186 Lori Chapman Unray Vol#: 412

C 6187 M. Douoherty Vol#: 412

C 6188 Alice Mitchell Vol#: 412

C 6189 Barry Kepp Vol#: 412

C 6190 John Helm Vol#: 412

C 6191 Peter Von Zur Muehlen Vol#: 412

C 6192 Jody Halton Vol#: 412

C 6193 R. Lynn Wakefield, MD Vol#: 412

C 6194 Marianne Klein Vol#: 412

C 6195 Todd Snow Vol#: 412

C 6196 Phillip Valleo Vol#: 412

C 6197 Frank Flinn Vol#: 412

C 6198 Alice Block Vol#: 412

C 6199 J. Bogosian Vol#: 412

C 6200 Teresa Dima Vol#: 412

C 6201 Rebecca Cook Vol#: 412

C 6202 Kathy Shelli Vol#: 412

C 6203 Susan Gash Vol#: 412

C 6204 Rachel Craft Vol#: 412

C 6205 Kristen Gramback Vol#: 412

C 6206 Sandra Coben Vol#: 412

C 6207 Rita Humphrey Vol#: 412

C 6208 Leslie Caras Vol#: 412

C 6209 B. Long Vol#: 412

C 6210 Marjorie Fulmer Vol#: 412

C 6211 Virginia Nolan Vol#: 412

C 6212 Cynthia Price Vol#: 412

C 6213 Pat Graham Vol#: 412

C 6214 Eric Saalborn Vol#: 412

C 6215 Yvonne Baker Vol#: 412

C 6216 John Draper Vol#: 412

C 6217 Kerry Hegarty Vol#: 412

C 6218 Roy Diethorn Vol#: 412

C 6219 Jeff Williams Vol#: 412

C 6220 Gail Salts Vol#: 412

C 6221 Dan Greifenberget Vol#: 412

C 6222 Lisa Messand Vol#: 412

C 6223 Northern Utah Organic Group Vol#: 412

EMC 10158 Kara MacKeigan Vol#: 411

EMC 10159 Carol Hanulcik Vol#: 411

EMC 10160 g a Vol#: 411

EMC 10161 Mimi Maloney Vol#: 411

EMC 10162 Mimi Maloney Vol#: 411

EMC 10163 Beverly B Ferguson Vol#: 411

EMC 10164 Michael Menichetti Vol#: 411

EMC 10165 Michael Menichetti Vol#: 411

EMC 10166 Hugh Bailey Vol#: 411

EMC 10167 John Schober Vol#: 411

EMC 10168 Susan "Freshspirit" Vol#: 411

EMC 10169 Sandie Hanson-Bjornson Vol#: 411

EMC 10170 Skye Leith Vol#: 411

EMC 10171 Kelly Cannata Vol#: 411

EMC 10172 Annemarie Colbin Vol#: 411

EMC 10173 Annemarie Colbin Vol#: 411

EMC 10174 Chris Wrinn Vol#: 411

EMC 10175 unsigned Vol#: 411

EMC 10176 Angela & Doug Parker-Simkin Vol#: 411

EMC 10177 Marlin Anderson Vol#: 411

EMC 10178 Sharon Henderson Vol#: 411

EMC 10179 Mark Rosen Vol#: 411

EMC 10180 John Sims Vol#: 411

EMC 10181 K Marsh Vol#: 411

EMC 10182 Julie Hudson Vol#: 411

EMC 10183 Kimberly Dodd Vol#: 411

EMC 10184 Teresa Gallagher Vol#: 411

EMC 10185 Teresa Gallagher Vol#: 411

EMC 10186 Jim Dawson Vol#: 411

EMC 10187 Ruth Margolis Vol#: 411

EMC 10188 John Allen Vol#: 411

EMC 10189 John Allen Vol#: 411

EMC 10190 Dennis Hull Vol#: 411

EMC 10191 Erin MacDonald Vol#: 411

EMC 10192 Marylyn P. Pauley Vol#: 411

EMC 10193 Peter LeClair Vol#: 411

EMC 10194 Paul Larson Vol#: 411

EMC 10195 Donna Cassano Vol#: 411

EMC 10196 Kathleen Smith Vol#: 411

EMC 10197 Kathleen Smith Vol#: 411

EMC 10198 Noah Hiken Vol#: 411

EMC 10199 Suzanne Glass Vol#: 411

EMC 10200 Suzanne Glass Vol#: 411

EMC 10201 Trina Paulus Vol#: 411

EMC 10202 Susan Tufts-Moore Vol#: 411

EMC 10203 Trent Elwing Vol#: 411

EMC 10204 Karen Walby Vol#: 411

EMC 10205 Stephanie McFarland Vol#: 411

EMC 10206 Sharon Duguay Vol#: 411

EMC 10207 Sharon Duguay Vol#: 411

EMC 10208 Simha Carroll Vol#: 411

EMC 10209 David Dillard Vol#: 411

EMC 10210 Carol Waddington Vol#: 411

EMC 10211 Carol Waddington Vol#: 411

EMC 10212 Doreen Miller Vol#: 411

EMC 10213 Doreen Miller Vol#: 411

EMC 10214 Lyle Nash Vol#: 411

EMC 10215 Carla Pestana Vol#: 411

EMC 10216 Carla Pestana Vol#: 411

EMC 10217 Mike Tetrault Vol#: 411

EMC 10218 unsigned Vol#: 411

EMC 10219 E John Fallon Vol#: 411

EMC 10220 E John Fallon Vol#: 411

EMC 10221 Shane Boosey Vol#: 411

EMC 10222 Shane Boosey Vol#: 411

EMC 10223 Bryce Nesbitt Vol#: 411

EMC 10224 Paula Merritt Vol#: 411

EMC 10225 Paula Merritt Vol#: 411

EMC 10226 P. McCullough Vol#: 411

EMC 10227 Stephen Horvath Vol#: 411

EMC 10228 Stephen Horvath Vol#: 411

EMC 10229 Jann Biggs-McNaughton Vol#: 411

EMC 10230 Jann Biggs-McNaughton Vol#: 411

EMC 10231 Kati Holland Vol#: 411

EMC 10232 R. Diddens Vol#: 411

EMC 10233 Faye Slice Vol#: 411

EMC 10234 Faye Slice Vol#: 411

EMC 10235 Lee Shinefield Vol#: 411

EMC 10236 Genevieve Sprinkle Vol#: 411

EMC 10237 Genevieve Sprinkle Vol#: 411

EMC 10238 Lisa and Paul Anderson Vol#: 411

EMC 10239 Mary Kay Craig Vol#: 411

EMC 10240 Mary Kay Craig Vol#: 411

EMC 10241 Chris Watson Vol#: 411

EMC 10242 Karin Edwards Vol#: 411

EMC 10243 Karin Edwards Vol#: 411

EMC 10244 Art & Cindy Strauss Vol#: 411

EMC 10245 Art & Cindy Strauss Vol#: 411

EMC 10246 Daniela Bajlo Vol#: 411

EMC 10247 Mario Ramirez Vol#: 411

EMC 10248 Mario Ramirez Vol#: 411

EMC 10249 Mr and Mrs Erik Jenson Vol#: 411

EMC 10250 John Rodenbarger Vol#: 411

EMC 10251 John Rodenbarger Vol#: 411

EMC 10252 John McGovern Vol#: 411

EMC 10253 John McGovern Vol#: 411

EMC 10254 Kim Marine-Okochi Vol#: 411

EMC 10255 Kim Marine-Okochi Vol#: 411

EMC 10256 Eric Brown Vol#: 411

EMC 10257 Chris Negrin Vol#: 411

EMC 10258 Chris Negrin Vol#: 411

EMC 10259 Heather O'Donnell Vol#: 411

EMC 10260 Caryl F. Burnett Vol#: 411

EMC 10261 David Freed Vol#: 411

EMC 10262 Margaret W. Chapman Vol#: 411

EMC 10263 Mr. & Mrs. B.R. Sacks Vol#: 411

EMC 10264 Marri McKinnon-Hust Vol#: 411

EMC 10265 Mary Lighthall Vol#: 411

EMC 10266 Mary Lighthall Vol#: 411

EMC 10267 Roy Fish Vol#: 411

EMC 10268 Roy Fish Vol#: 411

EMC 10269 Bernadette Kazmarski Vol#: 411

EMC 10270 Cindy Batton Vol#: 411

EMC 10271 Summer Farnese Vol#: 411

EMC 10272 Mary Quesnel Vol#: 411

EMC 10273 E. Albertson Vol#: 411

EMC 10274 E. Albertson Vol#: 411

EMC 10275 CJ Webber II Vol#: 411

EMC 10276 Kathryn A. Hynes Vol#: 411

EMC 10277 Kathryn A. Hynes Vol#: 411

EMC 10278 Michael Toner Vol#: 411

EMC 10279 Wayne Messere Vol#: 411

EMC 10280 Sara Kohn Vol#: 411

EMC 10281 Sara Kohn Vol#: 411

EMC 10282 Kevin and Eileen Kelly Vol#: 411

EMC 10283 Margaret Leonard Vol#: 411

EMC 10284 Mary Ann John Vol#: 411

EMC 10285 Marian Thompson Vol#: 411

EMC 10286 Marian Thompson Vol#: 411

EMC 10287 Nora Zablow Vol#: 411

EMC 10288 Nora Zablow Vol#: 411

EMC 10289 Alice Andrews Vol#: 411

EMC 10290 Ernest Lent Vol#: 411

EMC 10291 Ernest Lent Vol#: 411

EMC 10292 Linda K. Kelly Vol#: 411

EMC 10293 Rani Silverberg Vol#: 411

EMC 10294 Agnes Harkay Vol#: 411

EMC 10295 Agnes Harkay Vol#: 411

EMC 10296 Mark Fernen Vol#: 411

EMC 10297 unsigned Vol#: 411

EMC 10298 Jim Mellen Vol#: 411

EMC 10299 Rose Berry Vol#: 411

EMC 10300 Stuart Henderson Vol#: 411

EMC 10301 Rachel Cohen Vol#: 411

EMC 10302 Rachel Cohen Vol#: 411

EMC 10303 Mike Martin Vol#: 411

EMC 10304 Sherry Wilson Vol#: 411

EMC 10305 Eileen Theimer Vol#: 411

EMC 10306 Susan Revak Vol#: 411

EMC 10307 Susan Revak Vol#: 411

EMC 10308 Leah Sargent Vol#: 411

EMC 10309 Lisa Stewart Vol#: 411

EMC 10310 Georgia Di Martino Colombo Vol#: 411

EMC 10311 Christina Betteys Vol#: 411

EMC 10312 Daniel Wilkinson Vol#: 411

EMC 10313 Romany Wood Vol#: 411

EMC 10314 Sandy Courtnage Vol#: 411

EMC 10315 Joanne Webb Vol#: 411

EMC 10316 Ryan Schmidt Vol#: 411

EMC 10317 Diane Vulcan Vol#: 411

EMC 10318 Jane Sooby Vol#: 411

EMC 10319 Cynthia Jackson Vol#: 411

EMC 10320 Cynthia Jackson Vol#: 411

EMC 10321 Sean C. Massey Vol#: 411

EMC 10322 Walter Epp Vol#: 411

EMC 10323 Dr. Michael Shepherd Clarage Vol#: 411

EMC 10324 Jessica Lewis Vol#: 411

EMC 10325 Jessica Lewis Vol#: 411

EMC 10326 Trina Burke Vol#: 411

EMC 10327 Dorothy Bosco Vol#: 411

EMC 10328 Tom & Gail Wiley Vol#: 411

EMC 10329 Denise Cox Vol#: 411

EMC 10330 Denise Cox Vol#: 411

EMC 10331 John Hettinger Vol#: 411

EMC 10332 John Hettinger Vol#: 411

EMC 10333 Ellen Kamhi, Ph.D., R.N. Vol#: 411

EMC 10334 Simone Craig Vol#: 411

EMC 10335 Jo Kirkpatrick Vol#: 411

EMC 10336 Jennifer Kauhane Vol#: 411

EMC 10337 Ann Heglin Vol#: 411

EMC 10338 Jodi Medlar Vol#: 411

EMC 10339 Jeb Bateman Vol#: 411

EMC 10340 Linda Alexander Vol#: 411

EMC 10341 Linda Alexander Vol#: 411

EMC 10342 Linda E. Alexander Vol#: 411

EMC 10343 Linda E. Alexander Vol#: 411

EMC 10344 Jeremy Engel Vol#: 411

EMC 10345 Michael Blanks Vol#: 411

EMC 10346 Cathy Leung Vol#: 411

EMC 10347 Chris Koopmans Vol#: 411

EMC 10348 Chris Koopmans Vol#: 411

EMC 10349 Beth Siegelbaum Vol#: 411

EMC 10350 Beth Siegelbaum Vol#: 411

EMC 10351 Nejat Duzgunes Vol#: 411

EMC 10352 Nejat Duzgunes Vol#: 411

EMC 10353 Patti Liberman Vol#: 411

EMC 10354 Beth Hill Vol#: 411

EMC 10355 Barbara Hannelore' Vol#: 411

EMC 10356 Barbara Hannelore' Vol#: 411

EMC 10357 Anna Rhee Vol#: 411

EMC 10358 Anna Rhee Vol#: 411

00N-1396 Bioengineered Foods Consumed By Humans or Animals

EMC 10001 Nejat Duzgunes Vol#: 265

EMC 10002 Nejat Duzgunes Vol#: 265

EMC 10003 Patti Liberman Vol#: 265

EMC 10004 Beth Hill Vol#: 265

EMC 10005 Pablo Vol#: 265

EMC 10006 Paul W. Jones Vol#: 265

EMC 10007 Barbara Hannelore' Vol#: 265

EMC 10008 Barbara Hannelore' Vol#: 265

EMC 10009 Anna Rhee Vol#: 265

EMC 10010 Anna Rhee Vol#: 265

EMC 10011 Carlos Kohan Vol#: 265

EMC 10012 Christine Young Vol#: 265

EMC 10013 Martin Geller, M.D. Vol#: 265

EMC 10014 Martin Geller, M.D. Vol#: 265

EMC 10015 Beatriz Valdellon Vol#: 265

EMC 10016 Beatriz Valdellon Vol#: 265

EMC 10017 Richard Hansen Vol#: 265

EMC 10018 John R. Drenth Vol#: 265

EMC 10019 Richard Hansen Vol#: 265

EMC 10020 Kristin Lyon Vol#: 265

EMC 10021 Irene Szczech Vol#: 265

EMC 10022 Paul Palmer Vol#: 265

EMC 10023 Number not used Vol#: 265

EMC 10024 Scott D. Randolph Vol#: 265

EMC 10025 Tina Thornton Wrasse Vol#: 265

EMC 10026 Kurt and Irene Meschter Vol#: 265

EMC 10027 Liz Eastwood Vol#: 265

EMC 10028 Sarah Thornton Vol#: 265

EMC 10029 Natalie Hudson Vol#: 265

EMC 10030 Paul Wiley Vol#: 265

EMC 10031 Francesca Perez Vol#: 265

EMC 10032 Number not used Vol#: 265

EMC 10033 Delight Craft Vol#: 265

EMC 10034 Mary Ann Keefer Vol#: 265

EMC 10035 Dr. & Mrs. John Lally Vol#: 265

EMC 10036 Dr. & Mrs. John Lally Vol#: 265

EMC 10037 Bonnie Kreitler Vol#: 265

EMC 10038 Linda & Gene Sentz Vol#: 265

EMC 10039 Joanna Villiard Vol#: 265

EMC 10040 Jack E. Downhill, Jr., M.D. Vol#: 265

EMC 10041 Karen Green Stone Vol#: 265

EMC 10042 James Thomson Vol#: 265

EMC 10043 James Thomson Vol#: 265

EMC 10044 Marina Quinn-Benitt Vol#: 265

EMC 10045 Marina Quinn-Benitt Vol#: 265

EMC 10046 Barbara S. Tufts Vol#: 265

EMC 10047 Erinne L. Goodell Vol#: 265

EMC 10048 Erinne L. Goodell Vol#: 265

EMC 10049 Ted Bagg Vol#: 265

EMC 10050 Dan Inglis Vol#: 265

00P-0788 Totally Implanted Spinal Cord Stimulator

C 33 FORM LETTER COUNT 31 Vol#: 10

00P-1322 Food Labeling and Allergen Contamination Control

APE 36 Wayne Amchin Vol#: 13

APE 37 SHS North America Vol#: 13

APE 38 Capitol Associates Vol#: 13

APE 39 Embassy of Japan Vol#: 13

APE 40 Dept of Food Science & Technology Vol#: 13

APE 41 Ross Products Division Vol#: 13

APE 42 Senate Agriculture Comm Vol#: 13

APE 43 Food Marketing Institute Vol#: 13

APE 44 Watson Foods Co Inc Vol#: 13

APE 45 Ralston Foods Vol#: 13

APE 46 Victoria Geduld & Nancy Geduld Vol#: 13

APE 47 Embassy of Guatemala Vol#: 13

APE 48 Egg Nutrition Center Vol#: 13

APE 49 Newly Weds Foods Vol#: 13

APE 50 Sodexho Vol#: 13

APE 51 Enzyme Technical Assoc Vol#: 13

APE 52 Simmons Foods Inc Vol#: 13

APE 53 CTFA Vol#: 13

APE 54 Joseph LaRochelle Vol#: 13

APE 55 Institute of Food Technologists Vol#: 13

APE 56 Institute of Food Technologists Vol#: 13

APE 57 Nat'l Restaurant Assoc Vol#: 13

APE 58 Gerber Porducts Co Vol#: 13

01D-0025 Guidance for Industry - Yellow Corn & Dry-Milled

C 5 Ralston Foods Vol#: 1

C 6 Campbell Soup Company Vol#: 1

C 7 Coca-Cola Company Vol#: 1

01P-0303 Petition of Declaration, Calcitek Inc

SUP 1 Mary Masters Vol#: 1

01P-0333 Non-lyophilized Cytoxan

ACK 1 HFA-305 Vol#: 1

CP 1 ASTA Medica, Inc. Vol#: 1

01P-0334 Revoke Invalid FDA Regulations

ACK 1 HFA-305 to Washington Legal Foundation Vol#: 1

CP 1 Washington Legal Foundation Vol#: 1