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DOCKETS ENTERED on September 27, 2001

TABLE OF CONTENTS

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76N-052N OTC Nasal Decongestants *
94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims *
97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD *
97P-0130 Require Percentage Ingredient Labeling *
97P-0441 Regulatory Status of Cholestin red yeast rice *
98N-1038 Irradiation in the production, processing, &handling of food *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
98P-0504 Raw Molluscan Shellfish of Undetectable Levels *
98P-0610 Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-4613 Revoke the Regulation That Approved Posilac *
99P-5106 Identify Sources of Natural Flavorings *
01P-0230 Domestic Marketing & Importation of Transgenic Fish *
01P-0369 Request that FDA ban the production and sale of all ephedra *
01P-0440 ANDA Suitability Petition for Ganciclovir Sodium Injection *

76N-052N OTC Nasal Decongestants

EMC 119 Jeff Young Vol#: 76

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

EMC 515 Ann I. Schwab Vol#: 64

97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD

EMC 1 Evelyn O'Keeffe Vol#: 2

97P-0130 Require Percentage Ingredient Labeling

EMC 208 No signature Vol#: 4

EMC 209 Shawn McCarthy Vol#: 4

EMC 210 Anne Drew Vol#: 4

EMC 211 Tamas Kallos Vol#: 4

EMC 212 Tamas Kallos Vol#: 4

EMC 213 Gail Brewer Vol#: 4

EMC 214 No signature Vol#: 4

EMC 215 Anne H. Radway Vol#: 4

EMC 216 Sally Maier Vol#: 4

EMC 217 Carol L. Crow Vol#: 4

EMC 218 Anne C. Highland, PhD Vol#: 4

EMC 219 Sharon and Jeff Jens Vol#: 4

EMC 220 Scott DeShong Vol#: 4

EMC 221 No signature Vol#: 4

EMC 222 Patricia Williams Vol#: 4

EMC 223 Linda and Al Rowder Vol#: 4

EMC 224 Katie Prater Vol#: 4

EMC 225 Lisa K. Reynolds Vol#: 4

EMC 226 The Ashley Family Vol#: 4

EMC 227 Hugh D. Olmstread Vol#: 4

EMC 228 Elizabeth Bass Vol#: 4

EMC 229 Frank Nanney Vol#: 4

EMC 230 Hope Miller Vol#: 4

EMC 231 Edwin I. Ichiriu Vol#: 4

EMC 232 Margaret T. Goering Vol#: 4

EMC 233 Tim Klika Vol#: 4

EMC 234 Debreen Olivia Vol#: 4

EMC 235 Dianna Pease Vol#: 4

EMC 236 Chee Wong Vol#: 4

EMC 237 Alan E. Barrett Vol#: 4

EMC 238 Jene Bean Vol#: 4

EMC 239 Joann Price Vol#: 4

EMC 240 Shoshana Salzberg Vol#: 4

EMC 241 Mary Ann Douglas Vol#: 4

EMC 242 Michael Pfeiffer Vol#: 4

EMC 243 Shereen Fernandes Vol#: 4

EMC 244 Dorothy F. Clark Vol#: 4

EMC 245 Scott Westmark Vol#: 4

EMC 246 Jill Adams Vol#: 4

EMC 247 Caroline Gavin Vol#: 4

EMC 248 Sherlock Holmes Vol#: 4

EMC 249 Margaret R. Weeks Vol#: 4

EMC 250 Marilyn Elise Hulse Vol#: 4

EMC 251 Jan Hawkins, RN Vol#: 4

EMC 252 Esti Guttman Vol#: 4

EMC 253 M. Swanson Vol#: 4

EMC 254 Dina McKelvy Vol#: 4

EMC 255 Bill Cowan Vol#: 4

EMC 256 Carol Kepler Vol#: 4

EMC 257 Colleen Osten, RD Vol#: 4

EMC 258 Eleanor Snyder Vol#: 4

EMC 259 L. Henry Vol#: 4

EMC 260 Mary N. Shah, MD Vol#: 4

EMC 261 Barbara J. Seaney Vol#: 4

EMC 262 Alan Young Vol#: 4

EMC 263 Nancy Lee Vol#: 4

EMC 264 Ellen A. Petty Vol#: 4

EMC 265 Christina Szabo Vol#: 4

EMC 266 Josephine S. Carroll Vol#: 4

EMC 267 No signature Vol#: 4

EMC 268 Laurie Powsner Vol#: 4

EMC 269 Joyce M. Mante Vol#: 4

EMC 270 Sheldon A. Maskin Vol#: 4

97P-0441 Regulatory Status of Cholestin red yeast rice

EMC 10 Sharon Sullivan Vol#: 15

EMC 11 Jamie Vol#: 15

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

EMC 358 Christina Brewer Vol#: 172

EMC 359 Marsha Lee Sheiness Vol#: 172

EMC 360 Mayer Computer Services Vol#: 172

EMC 361 Margaret Nelson Vol#: 172

EMC 362 Irene & Guy Hofstein Vol#: 172

EMC 363 Hermine H. Marshall Vol#: 172

EMC 364 Elly Munsinger Vol#: 172

EMC 365 Joanne Nagy Vol#: 172

EMC 366 Maria Weber Vol#: 172

EMC 367 Arlette Lurie Vol#: 172

EMC 368 John A. Crockett Vol#: 172

EMC 369 Doug Cragoe Vol#: 172

EMC 370 Adrienne Sutton Vol#: 172

EMC 371 Jane Ann Hurst Vol#: 172

EMC 372 John LaForge Vol#: 172

EMC 373 Zelle Windham Vol#: 172

EMC 374 David Telep Vol#: 172

EMC 375 Candace Boheme Vol#: 172

EMC 376 Cassandra Woodin Vol#: 172

EMC 377 Laura Slitt Vol#: 172

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

C 5222 S. Soderstrom Vol#: 169

C 5223 Dorothy Hallen Vol#: 169

EMC 2305 Shirley Giesking Vol#: 169

98P-0504 Raw Molluscan Shellfish of Undetectable Levels

EMC 22 Denise Yonemoto Vol#: 28

EMC 23 Joanne Kinghorn Vol#: 28

EMC 24 Anna Jacus Vol#: 28

EMC 25 Gertrud Allen Vol#: 28

EMC 26 Susan Edelstein Vol#: 28

EMC 27 Mary Tafi Vol#: 28

EMC 28 Paul Fiscella Vol#: 28

EMC 29 Laura Cunningham Vol#: 28

EMC 30 Marie Lovenheim Vol#: 28

EMC 31 Lisa Bosler Vol#: 28

EMC 32 William Brazier Vol#: 28

EMC 33 Ryan Jackson Vol#: 28

EMC 34 Denise Yonemoto Vol#: 28

EMC 35 Kenneth Hasenfus Vol#: 28

EMC 36 Matt Ellsworth Vol#: 28

EMC 37 Heather Hopkins Vol#: 28

EMC 38 Jennifer Moore Vol#: 28

EMC 39 Stanley Smith Vol#: 28

EMC 40 James M. Nordlund Vol#: 28

EMC 41 Mary Lodato Vol#: 28

EMC 42 Colleen Bates Vol#: 28

EMC 43 Stephen Hunt Vol#: 28

EMC 44 Mark Smith Vol#: 28

EMC 45 Peter Zadis Vol#: 28

EMC 46 Patricia Johnson Vol#: 28

98P-0610 Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC

EMC 74 New York Health Plan Assn Vol#: 4

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

EMC 802 Maria Roxana O'Leary Vol#: 209

EMC 803 Lisa Southerland Vol#: 209

EMC 804 Renuka Vajrakarur Vol#: 209

EMC 805 Francisco Romero Vol#: 209

EMC 806 James M. Nordlund Vol#: 209

99P-1340 Declared Eternity eau de Parfum Misbranded

EMC 336 Brenda Wright Vol#: 18

EMC 337 Alyssa Pitts Vol#: 18

EMC 338 Robert Roxby Vol#: 18

99P-4613 Revoke the Regulation That Approved Posilac

EMC 2404 Lawrence Rose Vol#: 44

EMC 2405 Sandy Smith-Goff Vol#: 44

99P-5106 Identify Sources of Natural Flavorings

EMC 124 Hilary Perlin Vol#: 2

EMC 125 Eric Burgess Vol#: 2

EMC 126 May Snyder Vol#: 2

EMC 127 Sandra Woien Vol#: 2

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9486 Form Letter count 87 Vol#: 492

C 9487 Form Letter count 53 Vol#: 493

C 9488 Form Letter count 104 Vol#: 494

C 9489 Form Letters 89 Vol#: 502

00N-1200 Dietary Supplements Containing Ephedrine Alkaloids

EMC 31 Jim Eubanks Vol#: 78

EMC 32 Julia A. Delbridge Vol#: 78

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

EMC 269 Marilyn Nardoza Vol#: 6

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 207 Erin Madden Vol#: 23

01P-0369 Request that FDA ban the production and sale of all ephedra

EMC 1 Nik Willmore, PhD Vol#: 2

EMC 2 Denise Nance Vol#: 2

EMC 3 Ben Munguia Vol#: 2

01P-0440 ANDA Suitability Petition for Ganciclovir Sodium Injection

ACK 1 HFA-305 Vol#: 1

CP 1 Ben Venue Laboratories, Inc. Vol#: 1