DOCKETS ENTERED on June 25, 2001

TABLE OF CONTENTS

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78N-0301 OTC External Analgesic Drug Products

MM 11 HFD-560 & Chattem Inc Vol#: 102

80N-0042 Anticaries Drug Products for OTC Human Use

LET 48 Warner-Lambert Co. Vol#: 36

MT 10 HFD-560 & Warner-Lambert Co. Vol#: 36

95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability

MT 1 HFS-22 & American Obesity Association Vol#: 293

97N-0314 Prescription Drug Products; Levothyroxine Sodium

ANS 3 HFD-5 to Patton Boggs Vol#: 1

C 3 Jerome Stevens Pharmaceuitical Inc Vol#: 1

EMC 1 Wendi Adams Vol#: 1

EMC 2 Connecticut Endocrine Society Vol#: 1

EMC 3 ALDJ Vol#: 1

EMC 4 O R Jordan Vol#: 1

97P-0441 Regulatory Status of Cholestin red yeast rice

EMC 3 Celeste Wright Vol#: 15

97V-0455 Laser Light Show

EXP 1 CourtYards of Mackinaw, Mackinaw Crossin Vol#: 1

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

C 5017 Ms. Patricia Schwartz Vol#: 157

C 5018 Ms. Dawn Masturzo Vol#: 157

C 5019 Hazel M. Lawrence Vol#: 157

C 5020 Marlene G. Titus Vol#: 157

C 5021 Heather E. Burns Vol#: 157

C 5022 Josef Fusselmann Vol#: 157

C 5023 Debbie Henry Vol#: 157

C 5024 Marian Carter Vol#: 157

C 5025 Ms. Patricia Schwartz Vol#: 157

C 5026 Joyce C. Byrne Vol#: 157

C 5027 Envoy Entertainment Management Productio Vol#: 157

EMC 2110 Hana Maier Vol#: 157

EMC 2111 Peggy Schramm Vol#: 157

EMC 2112 Emil T. Bailey, Jr. Vol#: 157

EMC 2113 Genevieve Yuen Vol#: 157

EMC 2114 Jerome Mc Collom Vol#: 157

EMC 2115 Candace Allaman Vol#: 157

EMC 2116 Jennifer Barich Vol#: 157

EMC 2117 Dr. & Mrs. Harold Tsai Vol#: 157

EMC 2118 Rainy McGrew Vol#: 157

EMC 2119 Laura Reid & Family Vol#: 157

EMC 2120 Abby Klein Vol#: 157

EMC 2121 Diane Rice Vol#: 157

EMC 2122 Sherrie Shown Vol#: 157

EMC 2123 D. Fieri Vol#: 157

EMC 2124 Jeannie M, Vinson Vol#: 157

EMC 2125 Danielle Vol#: 157

EMC 2126 Kathy 834 Vol#: 157

EMC 2127 Kelly Hughart Vol#: 157

EMC 2128 Mike Perry Vol#: 157

EMC 2129 Alvaro Javier Suarez Visbal Vol#: 157

EMC 2130 Lavern Shell Vol#: 157

99N-1852 Status reports/postmarketing studies-human drugs&biological

C 8 Merck & Co Inc Vol#: 1

C 9 Genzyme Corporation Vol#: 1

99P-5106 Identify Sources of Natural Flavorings

EMC 93 Andy Schulgasser Vol#: 1

EMC 94 Amy Toren Vol#: 1

EMC 95 Amy Valencia, Mia Nelson Vol#: 1

EMC 96 Lisa Ullman Vol#: 1

EMC 97 Christian MacAuley Vol#: 1

EMC 98 Annabyun Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

C 4193 Tom Thoreau Vol#: 319

C 4194 John St. Laurent Vol#: 319

C 4195 Orah Watson Vol#: 319

C 4196 Jane Wakefield Vol#: 319

C 4197 Alan & Debra Centofante Vol#: 319

C 4198 Edward Hall Vol#: 319

C 4199 Joan P. Chalk Vol#: 319

C 4200 Ruth Rodwick Vol#: 319

C 4201 Mr & Mrs R. Perna Vol#: 319

C 4202 A. Mandic Vol#: 319

C 4203 Susan Ianniello Vol#: 319

C 4204 Suzanne Wigger Vol#: 319

C 4205 Patrick Lindley Vol#: 319

C 4206 Deborah S. Tyler Vol#: 319

C 4207 William G. Nagel Vol#: 319

C 4208 Gerry Fross Vol#: 319

C 4209 Michelle Ferrier Vol#: 319

C 4210 Dave Breder Vol#: 319

C 4211 Jennifer Zingler Vol#: 319

C 4212 Dave Breder Vol#: 319

C 4213 Mary Ellen Rech Vol#: 319

C 4214 Peter Williams Vol#: 320

C 4215 Heidi Williams Vol#: 320

C 4216 M. Kledt Vol#: 320

C 4217 Janis Ihrig Vol#: 320

C 4218 Kate Costello Vol#: 320

C 4219 Marina Skimamian Vol#: 320

C 4220 Turay Zaimi Vol#: 320

C 4221 Sue M. Wiseman Vol#: 320

C 4222 Aileen Lanz Vol#: 320

C 4223 K. Wood Vol#: 320

C 4224 Andrea Rosen Vol#: 320

C 4225 Thomas J. Taylor Vol#: 320

C 4226 Steven A. Meleski Vol#: 320

C 4227 Kirstina Nelson Vol#: 320

C 4228 David Sheldon Vol#: 320

C 4229 Jamie Danek Vol#: 320

C 4230 Susan E. Elder Vol#: 320

C 4231 Marian E. Elder Vol#: 320

C 4232 James P. Elder Vol#: 320

C 4233 Diana Morton Vol#: 320

C 4234 Mary K. Hambrock Vol#: 320

C 4235 Laura Randolph Vol#: 320

C 4236 Nelson Stalcup Vol#: 320

C 4237 Lynn DiEuliis Vol#: 320

C 4238 Forest Perry Vol#: 320

C 4239 David C. Roederer Vol#: 320

C 4240 Plesh Vol#: 320

C 4241 D. Crocker Vol#: 320

C 4242 S.M. Stevens Vol#: 320

C 4243 A Merwin Vol#: 320

C 4244 Jonathan Bruno Vol#: 320

C 4245 Laura M. Holunquist Vol#: 320

C 4246 Jean Bernard Vol#: 320

C 4247 Chris Matthews Vol#: 320

C 4248 Rebecca Horst Vol#: 320

C 4249 CSPI Vol#: 320

C 4250 Diane Todd, PhD Vol#: 320

C 4251 Ann Bollesen Vol#: 320

C 4252 Diane D. Tobin Vol#: 320

C 4253 Grace E. Urrico Vol#: 320

C 4254 Margaret McEntire Vol#: 320

C 4255 Vesta Lindstrom Vol#: 320

C 4256 Ken & Marilyn Jewell Vol#: 320

C 4257 Marshall McComb Vol#: 320

C 4258 Mary Jo Long, Attorney At Law Vol#: 320

C 4259 Jane Harold Vol#: 320

C 4260 Moreen R. Siegel Vol#: 320

C 4261 Sandy Tate Vol#: 320

C 4262 Virginia Johnson Vol#: 320

C 4263 D. Carlson Vol#: 320

C 4264 LaVonne J. Richardson Vol#: 320

C 4265 Lavada Riggins Vol#: 320

C 4266 Martha K. Voorhees Vol#: 320

C 4267 Marc S. Anderson Vol#: 320

C 4268 Patricia Stanko Vol#: 320

C 4269 Bonnie McIntire Vol#: 320

C 4270 Jessica Ollis Vol#: 320

C 4271 E. Edwards Vol#: 320

C 4272 Maria Leonard Vol#: 320

C 4273 Eugene T. Pompilio Vol#: 320

C 4274 Craig Tower Vol#: 320

C 4275 Betty Whiting Vol#: 320

C 4276 Sam Neuwirth Vol#: 320

C 4277 Bonnie Foster Vol#: 320

C 4278 Gail Miller Vol#: 320

C 4279 Michael Smith Vol#: 320

C 4280 Barbara A. Disborough Vol#: 320

C 4281 J Gregory Palma Vol#: 320

C 4282 Amy E. Winter Vol#: 320

C 4283 Ana Moore Vol#: 320

C 4284 Linda M. Axtell Vol#: 320

C 4285 Leera Stewart Vol#: 320

C 4286 Sam Haynie Vol#: 320

C 4287 Judith Torian Vol#: 320

C 4288 Mary A. Kahler Vol#: 320

C 4289 Adam D. Stiles Vol#: 320

C 4290 Joshua Resnikoff Vol#: 320

C 4291 Jenna Lomazzo Vol#: 320

C 4292 M. Husband Vol#: 320

C 4293 B.A. Harney Vol#: 320

C 4294 Basia Gingold, M.D. Vol#: 320

C 4295 Marilyn Stefonetti Vol#: 320

C 4296 Travis Johnson Vol#: 320

C 4297 Molly Scott Vol#: 320

C 4298 Victoria Small Vol#: 320

C 4299 John Cowen Vol#: 320

C 4300 Dawn Divina Vol#: 320

C 4301 Eric Tillinghast Vol#: 321

C 4302 Betty Chlystek Vol#: 321

C 4303 Kat Kaplan Vol#: 321

C 4304 Rachelle V. Costigan Vol#: 321

C 4305 Ruth D. Barefoot Vol#: 321

C 4306 N.J. Butterfield Vol#: 321

C 4307 Dorothy Warnock Vol#: 321

C 4308 Eric Malo Vol#: 321

C 4309 Lucas Rochwell Vol#: 321

C 4310 Elisabeth T. Smith Vol#: 321

C 4311 Rob Cruser Vol#: 321

C 4312 Stanton's Vol#: 321

C 4313 Sarah Kampa Vol#: 321

C 4314 Lawrence Larsen Vol#: 321

C 4315 Kay Withier Vol#: 321

C 4316 Candy Hall Vol#: 321

C 4317 Dina Dinelli Vol#: 321

C 4318 Cassandra Saulter Vol#: 321

C 4319 Marie N. Dalde Vol#: 321

C 4320 Leonard Sandez Vol#: 321

C 4321 Samuel M. Marin Vol#: 321

C 4322 Mary Pat Ford Vol#: 321

C 4323 Bonnie Stiles Vol#: 321

C 4324 Judy Krizmanic Vol#: 321

C 4325 C. Harold Richard Vol#: 321

C 4326 Mary Skumanich Vol#: 321

C 4327 Gil Miranda Vol#: 321

C 4328 V. Wesley Vol#: 321

C 4329 Carolyn & Steven Wagner Vol#: 321

C 4330 Eligible Vol#: 321

C 4331 Andrea Plaza Vol#: 321

C 4332 Victoria Hughes Vol#: 321

C 4333 Eligible Vol#: 321

C 4334 Susan Pinkett Vol#: 321

C 4335 Kathleen Senseng Vol#: 321

C 4336 Dot Tennies Vol#: 321

C 4337 Rachel H. Galloway Vol#: 321

C 4338 John Bowman Vol#: 321

C 4339 Jean Brussell Vol#: 321

C 4340 Form Letter Count 99 Vol#: 326

C 4341 Leigh M. Knox Vol#: 321

C 4342 Jeanne Henderson Vol#: 321

C 4343 M. Sanders Vol#: 321

C 4344 Deborah R. Osborne Vol#: 321

C 4345 Annette L. Ernst Vol#: 321

C 4346 Kathryn Sweedler-Derin Vol#: 321

C 4347 Margaret Harris Vol#: 321

C 4348 Mytzi Stoumbos Vol#: 321

C 4349 Dr. Awkward PhD Vol#: 321

C 4350 Deborah Watson Vol#: 321

C 4351 Michael Parrn Vol#: 321

C 4352 Michele Thornes Vol#: 321

C 4353 Mike Arnot Vol#: 321

C 4354 Beverly V. Jones Vol#: 321

C 4355 Kathleen Higginbotham Vol#: 321

C 4356 S. Shaffer Vol#: 321

C 4357 Jill M. Palmer Vol#: 321

C 4358 W.A. Carr Vol#: 321

C 4359 Mikaila Palmer Vol#: 321

C 4360 Peter Hirsch Vol#: 321

EMC 6933 S. Paskus Vol#: 318

EMC 6934 Lauren Gwin Vol#: 318

EMC 6935 Carmen DeVida Vol#: 318

EMC 6936 Peter Szameitat Vol#: 318

EMC 6937 Herbert Franck Vol#: 318

EMC 6938 Monte Gullo Vol#: 318

EMC 6939 Keith & Linda Copenhagen and Family Vol#: 318

EMC 6940 Sarah Divelbiss Vol#: 318

EMC 6941 Ray Kuzmich Vol#: 318

EMC 6942 Terri Sue Stone Vol#: 318

EMC 6943 Diane Slota Vol#: 318

EMC 6944 John Hagen-Brenner Vol#: 318

EMC 6945 Edward J. Klein Vol#: 318

EMC 6946 John Hagen-Brenner Vol#: 318

EMC 6947 unsigned Vol#: 318

EMC 6948 Hub Knott Vol#: 318

EMC 6949 Ann Fitzgerald Vol#: 318

EMC 6950 Alicia Goddard Vol#: 318

EMC 6951 Kira Hammond Vol#: 318

EMC 6952 David Moody Vol#: 318

EMC 6953 Michael Colfer, PhD Vol#: 318

EMC 6954 Lisa Pascopella, PhD, MPH Vol#: 318

EMC 6955 Pamela M. Round Vol#: 318

EMC 6956 unsigned Vol#: 318

EMC 6957 Livea Cherish Vol#: 318

EMC 6958 M.E. Hermes Vol#: 318

EMC 6959 Sharon Messer Vol#: 318

EMC 6960 Linda O'Brien Vol#: 318

EMC 6961 Susan Morris Bean Vol#: 318

EMC 6962 Judith Gais Vol#: 318

EMC 6963 Mark Richards Vol#: 318

EMC 6964 Marion and Allan Hunt-Badiner Vol#: 318

EMC 6965 Patsy Boyd Vol#: 318

EMC 6966 Vickie Vol#: 318

EMC 6967 Leroy Pletton Vol#: 318

EMC 6968 MA Mayer Vol#: 318

EMC 6969 Ralf Ruediger Vol#: 318

00N-1269 Labeling for human prescription drug/Biologic Products

C 39 PhRMA Vol#: 4

C 40 pharmacy OneSource Inc Vol#: 4

C 41 Eli Lilly and Company Vol#: 4

C 42 Susceptibility Testing Manufacturers A Vol#: 4

C 43 Optimum Vol#: 4

C 44 National Association of Chain Drug Store Vol#: 4

C 45 Pharmacia Corporation Vol#: 4

C 46 GlaxoSmithKline Vol#: 4

C 47 Immunex Corporation Vol#: 4

C 48 AARP Vol#: 5

C 49 Aventis Pharmaceuticals Inc Vol#: 5

C 50 Daiichi Pharmaceutical Corporation Vol#: 5

C 51 ViJuk Equipment Inc Vol#: 5

C 52 Georgetown University Medical Center Vol#: 5

C 53 Johnson & Johnson Vol#: 5

C 54 American Osteopathic Association Vol#: 5

00P-1496 Gulucophage (Metformin HCI) Tablets, 625 mg and 750mg,

ANS 1 HFD-7 to Lachman Consultant Services,Inc Vol#: 1

00P-1535 Biopsy forceps covers/non-electric biopsy as Class I devices

LET 2 HFZ-312 to Boston Scientific Corp. Vol#: 2

01D-0146 Deficient Submissions filed/Investigation of New Animal Drug

C 2 Animal Health Institute Vol#: 1

01D-0202 Provisions of the FDA Modernization Act of 1997

C 1 Yale University Vol#: 1

C 2 Medical Device manufacturers Association Vol#: 1

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

CS 4 HFA-305 Vol#: 1

OR 3 HF-3 Vol#: 1

01N-0103 180 day Genetic Exclusivity Intersection - Pediatric

C 5 GPhA, Generic Pharmaceutical Assn. Vol#: 1

01N-0135 Radiation Disclosure Statement Options For Foods

EMC 41 Lori Deutsch Vol#: 1

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

C 170 Mrs. Jesn Clark Vol#: 7

C 171 Fran Heider Vol#: 7

C 172 Georgia Kelm Vol#: 7

C 173 Sister M. Laurene Vol#: 7

C 174 Bonnie Burgardt Vol#: 7

C 175 F. Michael Carroll Vol#: 7

EMC 257 Paul R. Gardella, Jr. Vol#: 7

EMC 258 Clue Vol#: 7

EMC 259 Lee & Leona Fiala Vol#: 7

EMC 260 L. Wood Vol#: 7

EMC 261 C. Levins Vol#: 7

EMC 262 Richard J. Malone Vol#: 7

EMC 263 Mrs. Dorothy Giordano Vol#: 7

EMC 264 Barb Shambro Vol#: 7

EMC 265 Stephen Kreklo Vol#: 7

EMC 266 Lauretta Gaherty Vol#: 7

EMC 267 Vicki Johnson Vol#: 7

EMC 268 James C. McRoberts Vol#: 7

EMC 269 Diane Husk Vol#: 7

EMC 270 Elizabeth Kohles Vol#: 7

EMC 271 Mrs. Anthony Bienaman Vol#: 7

EMC 272 Rae Ann Urban Vol#: 7

EMC 273 Donald Urban Vol#: 7

EMC 274 Katherine Jones Vol#: 7

EMC 275 Julia Jones Vol#: 7

EMC 276 Betty Sanok Vol#: 7

EMC 277 Barbara J. Hinton Vol#: 7

EMC 278 Barbara Baker Vol#: 7

EMC 279 Aloha Kiliki Vol#: 7

EMC 280 J. J. Garrity Vol#: 7

EMC 281 Rich & Delores Cassani Vol#: 7

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 27 John Harrington Vol#: 5

C 28 John Wages Vol#: 5

C 29 Caroline Jones Vol#: 5

C 30 illegible Vol#: 5

C 31 Todd Frank Vol#: 5

C 32 Casey Paine Vol#: 5

C 33 David C. Palmer Vol#: 5

C 34 illegible Vol#: 5

C 35 illegible Vol#: 5

C 36 illegible Vol#: 5

C 37 Savanna Beaffert Vol#: 5

C 38 illegible Vol#: 5

01P-0259 Refuse to approve tegaserod (Zelmac)

C 2 Gail S Robinson PhD Vol#: 1

C 3 Celeste Walker Vol#: 1