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 May 17, 2001

TABLE OF CONTENTS

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97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
98P-0610 Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00N-1269 Labeling for human prescription drug/Biologic Products *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00N-1665 Consumer Roundtable; Notice of Meeting *
00P-1499 Remove alosetron (Lotronex) from the market *
01N-0153 Voluntary Registration of Cosmetic Product Establishments *
01N-0174 Agency Information Collection Recall Regulations *
01N-0178 Premarket Notification 510(k) Submissions *
01P-0235 Reclassification of Cyclosporine Immunoassay *

97S-0162 30-Day Structure Function Claim Notification Letters Dietary

LET 7088 Source Naturals Inc Vol#: 54

LET 7089 Source Naturals Inc Vol#: 54

LET 7090 Source Naturals Inc Vol#: 54

LET 7091 Horizon Nutraceuticals Vol#: 54

LET 7092 Horizon Nutraceuticals Vol#: 54

LET 7093 Source Naturals Vol#: 54

LET 7094 Source Naturals Vol#: 54

LET 7095 Source Naturals Vol#: 54

LET 7096 Source Naturals Vol#: 54

LET 7097 Source Naturals Vol#: 54

LET 7098 Source Naturals Vol#: 54

LET 7099 Source Naturals Vol#: 54

LET 7100 Source Naturals Vol#: 54

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

C 4749 C Patrick Vol#: 147

C 4750 S Martin Vol#: 147

C 4751 S Tweed Vol#: 147

C 4752 P Joralemon Vol#: 147

C 4753 J Flood Vol#: 147

C 4754 J Cobb Vol#: 147

C 4755 J Emich Vol#: 147

C 4756 D Schulte Vol#: 147

C 4757 N Nelson Vol#: 147

C 4758 B Bocca Vol#: 147

C 4759 G Hurst Vol#: 147

C 4760 D Norton Vol#: 147

C 4761 M. Groff Vol#: 147

C 4762 P Doyle Vol#: 147

C 4763 D Rodriquez Vol#: 147

C 4764 A Kantharia Vol#: 147

C 4765 W MacRae Vol#: 147

C 4766 N Markham Vol#: 147

C 4767 D Finger Vol#: 149

EMC 1790 T Vol#: 147

EMC 1791 Al. Queeno Vol#: 147

EMC 1792 K Santiago Vol#: 147

EMC 1793 P Connors Vol#: 147

EMC 1794 N Mitchell Vol#: 147

EMC 1795 S Baker Vol#: 147

EMC 1796 A Carter Vol#: 147

EMC 1797 B Reyes Vol#: 147

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

EC 1 L Mack Vol#: 3

EC 2 S Wilson Vol#: 3

EC 3 J Ferguson Vol#: 3

EC 4 M Barela Vol#: 3

EC 5 t newton Vol#: 3

EC 6 P Hellman Vol#: 3

EC 7 Private Citizen Vol#: 3

EC 8 State of New York OMRDD Vol#: 3

EC 9 S Smith Vol#: 3

EC 10 E Zirblis Vol#: 3

EC 11 R Hightower Vol#: 3

EC 12 M Mohr Vol#: 3

EC 13 A Hatch Vol#: 3

EC 14 B Willstaedt Vol#: 3

EC 15 Exalt! Communications LLC Vol#: 3

EC 16 M Wrasse Vol#: 3

00D-1598 Voluntary Labeling for Bioengineered Foods

C 2443 D. Shufelt Vol#: 169

C 2444 M Orefice Vol#: 169

C 2445 N Young Vol#: 169

C 2446 B Michaels Vol#: 169

C 2447 A Weaver Vol#: 169

C 2448 M Shakow Vol#: 169

C 2449 K. Nelson Vol#: 169

C 2450 R Griffiths Vol#: 169

C 2451 C Cloyed Vol#: 169

C 2452 L Evans Vol#: 169

C 2453 M Sutton Vol#: 169

C 2454 J Aparisi Vol#: 169

C 2455 L. Irish Vol#: 169

C 2456 T Urbanski Vol#: 169

C 2457 E Aeschlima Vol#: 169

C 2458 R Yost Vol#: 169

C 2459 K DeSmot Vol#: 169

C 2460 M. Walt Vol#: 169

C 2461 V Ware Vol#: 169

C 2462 D Wiggs Vol#: 169

C 2463 C Jagh Vol#: 169

C 2464 H. Kretkowski Vol#: 169

C 2465 C. Galvez Vol#: 169

C 2466 A. Johnston Vol#: 169

C 2467 E Walsh Vol#: 169

C 2468 D. Williams Vol#: 169

C 2469 K Long Vol#: 169

C 2470 C Durcholz Vol#: 169

C 2471 R Saunders Vol#: 169

C 2472 M Kubaska Vol#: 169

C 2473 L Ferris Vol#: 169

C 2474 A Butelle Vol#: 169

C 2475 Illegible Vol#: 169

C 2476 R Fieber Vol#: 169

C 2477 S Rhett Vol#: 169

C 2478 G Pauletto Vol#: 169

C 2479 Blood Root Vol#: 169

C 2480 Illegible Vol#: 169

C 2481 A Kemp Vol#: 169

C 2482 S Couto Vol#: 169

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

EC 16 F Shillander Vol#: 4

EC 17 ADVANTAGE FAMILY HEALTHCARE, PLLC Vol#: 4

EC 18 ADVANTAGE FAMILY HEALTHCARE, PLLC Vol#: 4

00N-1396 Bioengineered Foods Consumed By Humans or Animals

EMC 4169 D Pincon Vol#: 162

EMC 4170 L Nedderman Vol#: 162

EMC 4171 D Martin Vol#: 162

EMC 4172 T Allen Vol#: 162

EMC 4173 B McNally Vol#: 162

EMC 4174 N Bennett Vol#: 162

EMC 4175 G Rosard Vol#: 162

EMC 4176 D Bundy Vol#: 162

EMC 4177 Z Gollogly Vol#: 162

EMC 4178 J Lesyk Vol#: 162

EMC 4179 C Masajo Vol#: 162

EMC 4180 J Phelps Vol#: 162

EMC 4181 Y Lange Vol#: 162

EMC 4182 G Sappenfield Vol#: 162

EMC 4183 S Hershey Vol#: 162

EMC 4184 T Proetta Vol#: 162

EMC 4185 A Riben Vol#: 162

EMC 4186 B Rader Vol#: 162

EMC 4187 J Bob Vol#: 162

EMC 4188 B Hassan Vol#: 162

EMC 4189 S Abercrombie Vol#: 162

EMC 4190 M Pardee Vol#: 162

EMC 4191 number not used Vol#: 162

EMC 4192 A Williams Vol#: 162

EMC 4193 M Grefori Vol#: 162

EMC 4194 number not used Vol#: 162

EMC 4195 C Prata Vol#: 162

EMC 4196 P Gavlen Vol#: 162

EMC 4197 number not used Vol#: 162

EMC 4198 A Williams Vol#: 162

EMC 4199 number not used Vol#: 162

EMC 4200 K Popovic Vol#: 162

EMC 4201 Jason & Michelle Presley Vol#: 162

EMC 4202 M Caws Vol#: 162

EMC 4203 A Taylor Vol#: 162

EMC 4204 G Camhi Vol#: 162

EMC 4205 Onnilynn Vol#: 162

EMC 4206 C. Ramsey Vol#: 162

EMC 4207 M Finney Vol#: 162

EMC 4208 G Camhi Vol#: 162

EMC 4209 E Porter Vol#: 162

EMC 4210 E Porter Vol#: 163

EMC 4211 K Clark Vol#: 163

EMC 4212 P Daugherty Vol#: 163

EMC 4213 L Dibner Vol#: 163

EMC 4214 J Nickell Vol#: 163

EMC 4215 E Sulek Vol#: 163

EMC 4216 G Gilson Vol#: 163

EMC 4217 D McCafferty Vol#: 163

EMC 4218 S Terry Vol#: 163

EMC 4219 A Taylor Vol#: 163

EMC 4220 J Perlow Vol#: 163

EMC 4221 C Mandeville Vol#: 163

EMC 4222 F Fitzgerald Vol#: 163

EMC 4223 A Klusener Vol#: 163

EMC 4224 J Forehand Vol#: 163

EMC 4225 S Lerner Vol#: 163

EMC 4226 A Peet Vol#: 163

EMC 4227 T Beebe Vol#: 163

EMC 4228 A Cutchin Vol#: 163

EMC 4229 T Lambert Vol#: 163

EMC 4230 S LeMay Vol#: 163

EMC 4231 A Pallottie Vol#: 163

EMC 4232 E Flanick Vol#: 163

EMC 4233 J L Vol#: 163

EMC 4234 M Fairlight Vol#: 163

EMC 4235 J Culhane Vol#: 163

EMC 4236 number not used Vol#: 163

EMC 4237 number not used Vol#: 163

EMC 4238 M Spicer Vol#: 163

EMC 4239 L Brinkman Vol#: 163

EMC 4240 J Siegel Vol#: 163

EMC 4241 J Knight Vol#: 163

EMC 4242 C Bodiford Vol#: 163

EMC 4243 C Violett Vol#: 163

EMC 4244 G Hughes Vol#: 163

EMC 4245 S Edmunds Vol#: 163

EMC 4246 C Varchaver Vol#: 163

EMC 4247 P Donath Vol#: 163

EMC 4248 M Sutherland Vol#: 163

EMC 4249 S Wood Vol#: 163

EMC 4250 S Zinser Vol#: 163

EMC 4251 G Ryan Vol#: 163

EMC 4252 D Dretzin Vol#: 163

EMC 4253 D Wirth Vol#: 163

EMC 4254 M Nowakowski Vol#: 163

EMC 4255 M Tankel Vol#: 163

EMC 4256 S Eaton Vol#: 163

EMC 4257 J Stamp Vol#: 163

EMC 4258 G Logan Vol#: 163

EMC 4259 C Minnick Vol#: 163

EMC 4260 J Coker Vol#: 163

EMC 4261 K Picelle Vol#: 163

EMC 4262 V Niederhoffer Vol#: 163

EMC 4263 D Banner Vol#: 163

EMC 4264 E Asarian Vol#: 163

EMC 4265 E Asarian Vol#: 163

EMC 4266 J Kowal Vol#: 163

EMC 4267 L Tiberi Vol#: 163

EMC 4268 number not used Vol#: 163

EMC 4269 A Esterling Vol#: 163

EMC 4270 D O'Carroll Vol#: 163

EMC 4271 J Slimak Vol#: 163

EMC 4272 G Molkenthin Vol#: 163

EMC 4273 K McConnon Vol#: 163

EMC 4274 N French Vol#: 163

EMC 4275 A Berenstein Vol#: 163

EMC 4276 S Dalton Vol#: 163

EMC 4277 M McMullen Vol#: 163

EMC 4278 D Nichols Vol#: 163

EMC 4279 K Rahal Vol#: 163

EMC 4280 D Rose Vol#: 163

EMC 4281 M Hartnabrigg Vol#: 163

EMC 4282 R Radzins Vol#: 163

EMC 4283 M KirkWagner Vol#: 163

EMC 4284 J Tressler Vol#: 163

EMC 4285 P Fulda Vol#: 163

EMC 4286 B Galley Vol#: 163

EMC 4287 J Coull Vol#: 163

EMC 4288 L Hill Vol#: 163

EMC 4289 B Nolan Vol#: 163

EMC 4290 K Gardner Vol#: 163

EMC 4291 S Maldovan Vol#: 163

EMC 4292 B Larcom Vol#: 163

EMC 4293 D Gardner Vol#: 163

EMC 4294 S. Hopkins Vol#: 163

EMC 4295 D Foerster Vol#: 163

EMC 4296 I Scharf Vol#: 163

EMC 4297 D Yupatoff Vol#: 163

EMC 4298 C Dean Vol#: 163

EMC 4299 T Rehkugler Vol#: 163

EMC 4300 D Austin Vol#: 163

EMC 4301 E Redcross Vol#: 163

EMC 4302 P Svrcek Vol#: 163

EMC 4303 D Ung Vol#: 163

EMC 4304 S Modick Vol#: 163

EMC 4305 K Cooperman Vol#: 163

EMC 4306 G Alper Vol#: 163

EMC 4307 S Odom Vol#: 163

EMC 4308 C Vadala Vol#: 163

EMC 4309 S Rogers Vol#: 163

EMC 4310 J Rasmuson Vol#: 163

EMC 4311 A Dillon Vol#: 163

EMC 4312 C Allison Vol#: 163

EMC 4313 D. Greenbaum Vol#: 163

EMC 4314 J Glaser Vol#: 163

EMC 4315 B Taylor Vol#: 163

EMC 4316 J Caruso Vol#: 163

EMC 4317 S Keelng Vol#: 163

EMC 4318 S. Storer Vol#: 163

EMC 4319 C Squiers Vol#: 163

EMC 4320 B Madsen Vol#: 163

EMC 4321 J Ortlieb Vol#: 163

EMC 4322 E Gore Vol#: 163

EMC 4323 E Campbell Vol#: 163

EMC 4324 M Weston Vol#: 163

EMC 4325 C Fritz Vol#: 163

EMC 4326 L Mathews Vol#: 163

EMC 4327 P Perras Vol#: 163

EMC 4328 C Hinkelman Vol#: 163

EMC 4329 J Fallin Vol#: 163

EMC 4330 M Landa Vol#: 163

EMC 4331 A Kuwabara Vol#: 163

EMC 4332 M Villafranca Vol#: 163

EMC 4333 H Pennington Vol#: 163

EMC 4334 L Scher Vol#: 163

EMC 4335 R Schneider Vol#: 163

EMC 4336 D Waltermeyer Vol#: 163

EMC 4337 M Borgens Vol#: 163

EMC 4338 R Dunstan Vol#: 163

EMC 4339 B Rontal Vol#: 163

EMC 4340 L Marks Vol#: 163

EMC 4341 L Evans Vol#: 163

EMC 4342 S Borda Vol#: 163

EMC 4343 P Van Orden Vol#: 163

EMC 4344 B Stone Vol#: 163

EMC 4345 Jan Levenson Vol#: 163

EMC 4346 E Shaw Vol#: 163

EMC 4347 N Latimer Vol#: 163

EMC 4348 R Ratliff Vol#: 163

EMC 4349 S Rivas Vol#: 163

EMC 4350 K Sessions Vol#: 163

EMC 4351 S Shapiro Vol#: 163

EMC 4352 R. Perrymore Vol#: 163

EMC 4353 S Gardner Vol#: 163

EMC 4354 J Ray Vol#: 163

EMC 4355 C Celia Vol#: 163

EMC 4356 C Williams Vol#: 163

EMC 4357 A L Vol#: 163

EMC 4358 M Cortelyou Vol#: 163

EMC 4359 T Martin Vol#: 163

EMC 4360 C Betton Vol#: 163

EMC 4361 J Conte Vol#: 163

EMC 4362 T. Squirek Vol#: 163

EMC 4363 J Kressin Vol#: 163

EMC 4364 N Bland Vol#: 163

EMC 4365 R Woodruff Vol#: 163

EMC 4366 M Monroe Vol#: 163

EMC 4367 C Liao Vol#: 163

EMC 4368 no signature Vol#: 163

EMC 4369 no signature Vol#: 163

EMC 4370 J Sontag Vol#: 163

EMC 4371 S Ratapu Vol#: 163

EMC 4372 R. Mays Vol#: 163

EMC 4373 D Hamann Vol#: 163

EMC 4374 S. Gardner Vol#: 163

EMC 4375 J Lind Vol#: 163

EMC 4376 J Malone Vol#: 163

EMC 4377 D Cahill Vol#: 163

EMC 4378 J Maddox Vol#: 163

EMC 4379 E Magoun Vol#: 163

EMC 4380 K Nachinoff Vol#: 163

EMC 4381 M Federico Vol#: 163

EMC 4382 S. Tanida Vol#: 163

EMC 4383 N. Butterfield Vol#: 163

EMC 4384 J. Harris Vol#: 163

EMC 4385 M McCallister Vol#: 163

EMC 4386 S Vaughan Vol#: 163

EMC 4387 P DeVillier Vol#: 163

EMC 4388 C Henderson Vol#: 163

EMC 4389 T Boyle Vol#: 163

EMC 4390 number not used Vol#: 163

EMC 4391 E. Paviour Vol#: 163

EMC 4392 J. Hedquist Vol#: 163

EMC 4393 M. Serrine Vol#: 163

EMC 4394 J Main Vol#: 163

EMC 4395 ErnestPaviour Vol#: 163

EMC 4396 G Crosby Vol#: 163

EMC 4397 B Foster Vol#: 163

EMC 4398 D Solte Vol#: 163

EMC 4399 M Magee Vol#: 163

EMC 4400 R. Fraley Vol#: 163

EMC 4401 J. Meyers Vol#: 163

EMC 4402 C. Ercegovich Vol#: 163

EMC 4403 W Vought Vol#: 163

EMC 4404 M. Schneider Vol#: 163

EMC 4405 L Wieland Vol#: 163

EMC 4406 C Franz Vol#: 163

EMC 4407 W. Leete Vol#: 163

EMC 4408 L Kim Vol#: 163

EMC 4409 D Waxman Vol#: 163

EMC 4410 M Dillbeck Vol#: 163

EMC 4411 A Malek Vol#: 163

EMC 4412 no signature Vol#: 163

EMC 4413 L Hall Vol#: 163

EMC 4414 R Wood Vol#: 163

EMC 4415 T Cooper Vol#: 163

EMC 4416 R Blake Vol#: 163

EMC 4417 L Brooks Vol#: 163

EMC 4418 R Pritchard Vol#: 163

EMC 4419 M. Winningham Vol#: 163

EMC 4420 I Levi Vol#: 163

EMC 4421 V. Lasher Vol#: 163

EMC 4422 F. Fox Vol#: 163

EMC 4423 G Sereni Vol#: 163

EMC 4424 P Vaughan Vol#: 163

EMC 4425 K. Martin Vol#: 163

EMC 4426 number not used Vol#: 163

EMC 4427 J Allon Vol#: 163

EMC 4428 D Stephens Vol#: 163

EMC 4429 R. Stimson Vol#: 163

EMC 4430 P Truman Vol#: 163

EMC 4431 R. Ward Vol#: 163

EMC 4432 no signature Vol#: 163

EMC 4433 J Gauss Vol#: 163

EMC 4434 D. Allen Vol#: 163

EMC 4435 A Wolf Vol#: 163

EMC 4436 M. Vail Vol#: 163

EMC 4437 J Chappell Vol#: 163

EMC 4438 no signature Vol#: 163

EMC 4439 B Beard Vol#: 163

EMC 4440 F Butler Vol#: 163

EMC 4441 J Vol#: 163

EMC 4442 W Vol#: 163

EMC 4443 K Nemeth Vol#: 163

EMC 4444 C Trask Vol#: 163

EMC 4445 N Vol#: 163

EMC 4446 no signature Vol#: 163

EMC 4447 C Rama Vol#: 163

EMC 4448 J Hawk Vol#: 163

EMC 4449 B Lynch Vol#: 163

00N-1665 Consumer Roundtable; Notice of Meeting

EC 17 S Neudorf Vol#: 1

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

C 66 V Radcliffe Vol#: 4

EMC 267 R Apeldorn Vol#: 5

EMC 268 R. Schwab, M.D. Vol#: 5

01N-0153 Voluntary Registration of Cosmetic Product Esstablishments

EC 1 Green Party of Washington State Vol#: 1

01N-0174 Agency Information Collection Recall Regulations

EC 1 M Small Vol#: 1

EC 2 C Fernandez Vol#: 1

EC 3 J Chaffee Vol#: 1

01N-0178 Premarket Notification 510(k) Submissions

EC 1 test test Vol#: 1

EC 2 S Becker Vol#: 1

01P-0235 Reclassification of Cyclosporine Immunoassay

ACK 1 HFA-305 Vol#: 1

CCP 1 Microgenics, Inc. Vol#: 1

01V-0237 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Nu-Salt Laser Vol#: 1

Page update October 22, 2003 jb