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 February 1, 2001

TABLE OF CONTENTS

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

96P-0215 Withdrawal Norplant's approval for sale in the United States *

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

99F-2673 Irradiation in the Production, Processing & Handling of Food *

99P-1340 Declared Eternity eau de Parfum Misbranded *

99P-5106 Identify Sources of Natural Flavorings *

00D-1458 Infant/Child Apnea Monitor 510(K)Submissions *

00D-1598 Voluntary Labeling for Bioengineered Foods *

00N-0989 Human Gene Therapy *

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

00N-1665 Consumer Roundtable; Notice of Meeting *

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *

00P-1432 Pregnancy Warning Language on OTC Nicotine Products *

00P-1655 ANADA Application; Proposed product differ from appoved list *

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

EC 12 Nutritionist in private practice Vol#: 64

96P-0215 Withdrawal Norplant's approval for sale in the United States

C 231 C Donato Vol#: 6

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

C 3514 U. Moses Vol#: 111

C 3515 D Pace Vol#: 111

C 3516 M Wicks Vol#: 111

C 3517 J Schappe Vol#: 111

C 3518 D Foley et al Vol#: 111

C 3519 N. Paola Vol#: 111

C 3520 M. Bryson Vol#: 111

C 3521 M. Lambros Vol#: 111

C 3522 R Flygar Vol#: 111

C 3523 J Edlefsen Vol#: 111

C 3524 H Pasquale Vol#: 111

C 3525 S Alpern Vol#: 111

C 3526 C Shannon Vol#: 111

C 3527 S Cook Vol#: 111

C 3528 J Segers Vol#: 111

C 3529 D Holly Vol#: 111

C 3530 S Taylor Vol#: 111

C 3531 G Watts Vol#: 111

C 3532 M McAleenan Vol#: 111

C 3533 T Terry Vol#: 111

C 3534 S Gechtoff Vol#: 111

C 3535 C Brannon Vol#: 111

C 3536 A Alban Vol#: 111

C 3537 N Carrethers Vol#: 111

C 3538 no signature Vol#: 111

C 3539 C Galicic Vol#: 111

C 3540 E Marks Vol#: 111

C 3541 V Lamarche Vol#: 111

C 3542 L Fisher Vol#: 111

C 3543 J. Sherman Vol#: 111

C 3544 F Eliton Vol#: 111

C 3545 M Bologna Vol#: 111

C 3546 B Lucas Vol#: 111

C 3547 R Anderlik Vol#: 111

C 3548 S Breslin-Robusto Vol#: 111

C 3549 A Mallow Vol#: 112

C 3550 J Fish Vol#: 112

C 3551 K Shopa Vol#: 112

C 3552 St. Lawrence Environmental Action Vol#: 112

C 3553 B Frey Vol#: 112

C 3554 B Rand Vol#: 112

C 3555 E Piccioni Vol#: 112

C 3556 H Clemson Vol#: 112

C 3557 R Bellaris Vol#: 112

C 3558 P McDaniel. Vol#: 112

C 3559 J. Schoen Vol#: 112

C 3560 C Hull Vol#: 112

C 3561 American Business Forms & Promotions Vol#: 112

C 3562 25 signatures Vol#: 112

C 3563 F Bartkiewicz Vol#: 112

C 3564 K Levinson Vol#: 112

C 3565 L Farrell Vol#: 112

C 3566 M Maley Vol#: 112

C 3567 S. Fontanarose Vol#: 112

C 3568 Laren C. Vol#: 112

C 3569 A Lang Vol#: 112

C 3570 C Sefcik et al Vol#: 112

C 3571 H Delvecchio Vol#: 112

C 3572 B Mulholland Vol#: 112

C 3573 D Lively Vol#: 112

C 3574 V Trethewey Vol#: 112

C 3575 D Mowatt Vol#: 112

C 3576 S Cumine Vol#: 112

C 3577 J. Marren Vol#: 112

C 3578 K. Phillips Vol#: 112

C 3579 L Lyall Vol#: 112

C 3580 P Poole Vol#: 112

C 3581 D Rutecki Vol#: 112

C 3582 Civitas Citizens for Planetary Health Vol#: 112

C 3583 M Waters Vol#: 112

C 3584 M O'Brien Vol#: 112

C 3585 J Petzko Vol#: 112

C 3586 S Martilotto Vol#: 112

C 3587 ENVOY Entertainment Management Productio Vol#: 112

C 3588 P Tomsik Vol#: 112

C 3589 K Danby Vol#: 112

EMC 738 J Vance Vol#: 112

EMC 739 B Herner Vol#: 112

EMC 740 T Chin Vol#: 112

EMC 741 Animal Liberation Queensland (Australia) Vol#: 112

EMC 742 K Wenger Vol#: 112

EMC 743 L Hepner Vol#: 112

EMC 744 B Mckenney Vol#: 112

EMC 745 AnimalVoices We Speak For Critters Who C Vol#: 112

EMC 746 D Romero Vol#: 112

EMC 747 J Caracci Vol#: 112

EMC 748 Columbia University Action Coalition Vol#: 112

EMC 749 M Polner Vol#: 112

EMC 750 J Rogers Vol#: 112

EMC 751 M Thornton Vol#: 112

EMC 752 L Miller Vol#: 112

EMC 753 M Rickson Vol#: 112

EMC 754 L Stacy Vol#: 112

EMC 755 R Gartner Vol#: 112

EMC 756 J Hamlin Vol#: 112

EMC 757 K Willmann Vol#: 112

EMC 758 M Hillsamer Vol#: 112

EMC 759 M Bishop Vol#: 112

EMC 760 J Krumlauf Vol#: 112

EMC 761 Edison Enterprises, Inc. Vol#: 112

EMC 762 J Ganeles Vol#: 112

EMC 763 I Mills Vol#: 112

EMC 764 J Stern Vol#: 112

EMC 765 S Porter Vol#: 112

EMC 766 O Lusiene Vol#: 112

EMC 767 R Wright Vol#: 112

EMC 768 S Polacco Vol#: 112

EMC 769 S Akehurst Vol#: 112

EMC 770 S Dahl Vol#: 112

98V-0657 Laser Lighting Effects

EXP 1 Laser Fantasy International Vol#: 1

99F-2673 Irradiation in the Production, Processing & Handling of Food

C 29 S Hinckley Vol#: 2

C 30 J Raby Vol#: 2

C 31 Jonathan Sprouts (Organic) Inc Vol#: 2

EMC 63 L Schmeidler Vol#: 2

EMC 64 S Lopes Vol#: 2

EMC 65 P Espinosa Vol#: 2

EMC 66 N Brenner Vol#: 2

EMC 67 N Batalion Vol#: 2

EMC 68 Number not used Vol#: 2

EMC 69 P Moss Vol#: 2

EMC 70 G Bloss Vol#: 2

EMC 71 D Knowles Vol#: 2

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

C 16936 W Russell Vol#: 488

C 16937 H Wilson (CI) Vol#: 488

EMC 3368 C Safiran Vol#: 488

EMC 3369 Number not used Vol#: 488

EMC 3370 C Summer Vol#: 488

EMC 3371 M Ramthun Vol#: 488

EMC 3372 Number not used Vol#: 488

99P-1340 Declared Eternity eau de Parfum Misbranded

C 673 C Sachs Vol#: 16

C 674 M Higgins Vol#: 16

99P-5106 Identify Sources of Natural Flavorings

C 8 K Folsom Vol#: 1

00D-1458 Infant/Child Apnea Monitor 510(K)Submissions

C 1 Greener Pastures (GP) Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

EMC 232 S Sikora Vol#: 9

EMC 233 J Tober Vol#: 9

EMC 234 J Hildebrant Vol#: 9

EMC 235 S Service Vol#: 9

EMC 236 D Carey Vol#: 9

EMC 237 R Bell Vol#: 9

EMC 238 W McGee Vol#: 9

EMC 239 M Bernal Vol#: 9

EMC 240 L Sweet Vol#: 9

EMC 241 H Gardner Vol#: 9

EMC 242 V Prozan Vol#: 9

EMC 243 S Roberts Vol#: 9

EMC 244 L Gauvin Vol#: 9

EMC 245 V Hawkinson Vol#: 9

EMC 246 H Doress Vol#: 9

EMC 247 S Green Vol#: 9

EMC 248 E Long Vol#: 9

EMC 249 C Ahn Vol#:

EMC 250 C Costa Vol#: 9

EMC 251 A Whinston Vol#: 9

EMC 252 T Walker Vol#: 9

EMC 253 R Maehr Vol#: 9

EMC 254 J Willis Vol#: 9

EMC 255 R Golden Vol#: 9

EMC 256 Number Not Used Vol#: 9

EMC 257 P Meyers Vol#: 9

EMC 258 L Brunner Vol#: 9

EMC 259 J Eskenazi Vol#: 9

EMC 260 B Daley Vol#: 9

EMC 261 L German Vol#: 9

EMC 262 S Koprak Vol#:

EMC 263 E Getker Vol#:

EMC 264 M Steeg Vol#:

EMC 265 G James Vol#:

EMC 266 L Novenski Vol#:

EMC 267 S Elliott Vol#:

EMC 268 P Bily Vol#: 9

EMC 269 L Tittle Vol#: 9

EMC 270 M Renov Vol#: 9

EMC 271 A Stoltzfus Vol#: 9

EMC 272 W Miller Vol#: 9

EMC 273 F Vincent Vol#: 9

EMC 274 A Burgener Vol#: 9

EMC 275 D Edelman Vol#: 9

EMC 276 J Bucki Vol#: 9

EMC 277 M Fuller Vol#: 9

EMC 278 M Bury Vol#: 9

EMC 279 M Wagner Vol#: 9

EMC 280 T Macinata Vol#: 9

EMC 281 E Korza Vol#: 9

EMC 282 D Harrah Vol#: 9

EMC 283 R Brian Levy Vol#: 9

EMC 284 K Peck Vol#: 9

EMC 285 D Inouye Vol#: 9

EMC 286 C Bowers Vol#: 9

EMC 287 D Cox Vol#: 9

EMC 288 J Willis Vol#: 9

EMC 289 H Sands Vol#: 9

EMC 290 P Nystrom Vol#: 9

EMC 291 L Gates Vol#: 9

EMC 292 C Snyder Vol#: 9

EMC 293 J Grover Vol#: 9

EMC 294 A Mays Vol#: 9

EMC 295 H Sigfridsson Vol#: 9

EMC 296 R MacDiarmid Vol#: 9

EMC 297 T Sikora Vol#: 9

EMC 298 M Blubaugh Vol#: 9

EMC 299 S Myers Vol#: 9

EMC 300 M Hagerty Vol#: 9

EMC 301 M Anderson Vol#: 9

EMC 302 G Ashley Vol#: 9

EMC 303 Y Genocide Vol#: 9

EMC 304 M Sackin Vol#: 9

EMC 305 L Cherney Vol#: 9

EMC 306 A Graf Vol#: 9

EMC 307 S Lovitz Vol#: 9

EMC 308 S Wright Vol#: 9

EMC 309 S Farabaugh Vol#: 9

EMC 310 L Wright Vol#: 9

EMC 311 T Goedeke Vol#: 9

EMC 312 R Boley Vol#: 9

EMC 313 K Petersen Vol#: 9

EMC 314 B Clawson Vol#: 9

EMC 315 R Harper-McIntosh Vol#: 9

EMC 316 J Kallgren Vol#: 9

EMC 317 J Martin Vol#: 9

EMC 318 J Huber Vol#: 9

EMC 319 J Huber Vol#: 9

EMC 320 C Martinet Vol#: 9

EMC 321 L Cline Vol#: 9

EMC 322 T Emerson Vol#: 9

EMC 323 M Jones Vol#: 9

EMC 324 A Tucker Vol#: 9

EMC 325 D Victor Vol#: 9

EMC 326 K Stevens Vol#: 9

EMC 327 J Dean Vol#: 9

EMC 328 M Spear Vol#: 9

EMC 329 M Wolmark Vol#: 9

EMC 330 M Higler Vol#: 9

00N-0989 Human Gene Therapy

EMC 1 Giaslamo Vol#: 1

00N-1200 Dietary Supplements Containing Ephedrine Alkaloids

C 52 Sam Farr (CI) Vol#: 78

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

C 1 S Altaie Vol#: 2

00N-1665 Consumer Roundtable; Notice of Meeting

EC 5 NA Vol#: 1

EC 6 B Windham Vol#: 1

EC 7 B Windham Vol#: 1

EC 8 na Vol#: 1

EC 9 S Kreider Vol#: 1

EC 10 S Kreider Vol#: 1

EC 11 L Durfee Vol#: 1

EC 12 S Kreider Vol#: 1

EC 13 Number Not Used Vol#: 1

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 8293 N. Decisert Vol#: 662

C 8294 G McDowell Vol#: 662

C 8295 J Jackson Vol#: 662

C 8296 L Cavalier Vol#: 662

C 8297 L. Turzo Vol#: 662

C 8298 D Elzea Vol#: 662

C 8299 A Piselli Vol#: 662

C 8300 M McDowell Vol#: 662

C 8301 P Butler Vol#: 662

C 8302 M Becker Vol#: 662

C 8303 J Dennis Vol#: 662

C 8304 H Fisher Vol#: 662

C 8305 K Tsvatsios Vol#: 662

C 8306 L Rowe Vol#: 662

C 8307 L Sherbourne Vol#: 662

C 8308 A Rewcastle Vol#: 662

C 8309 K Walker Vol#: 662

C 8310 W V-Hess Vol#: 662

C 8311 L Word Vol#: 662

C 8312 R Hart Vol#: 662

C 8313 W Qualls Vol#: 662

C 8314 S Loomis Vol#: 662

C 8315 L Wright Vol#: 662

C 8316 J Elken Vol#: 662

C 8317 D Allmer Vol#: 662

C 8318 H Popoff Vol#: 662

C 8319 M Wickenbine Vol#: 662

C 8320 I Cordnan Vol#: 662

C 8321 C Gallucci Vol#: 662

C 8322 P Cherrington Vol#: 662

C 8323 N Ho Vol#: 662

C 8324 G Swanberg Vol#: 662

C 8325 L Pace Vol#: 662

C 8326 R Wright Vol#: 662

C 8327 R Pogacar Vol#: 662

C 8328 T Harnden Vol#: 662

C 8329 A Victor Vol#: 662

C 8330 L Mauck Vol#: 662

C 8331 A Maddox Vol#: 662

C 8332 G Hutchings Vol#: 662

C 8333 P Ryan Vol#: 662

C 8334 K Hanks Vol#: 662

C 8335 J Hiatt Vol#: 662

C 8336 P Braley Vol#: 662

C 8337 C Barrett Vol#: 662

C 8338 L Conley Vol#: 662

C 8339 L Gaten Vol#: 662

C 8340 D Wernett Vol#: 662

C 8341 G Aurand Vol#: 662

C 8342 C Crawford Vol#: 662

C 8343 M Adams Vol#: 662

C 8344 L Melkus Vol#: 662

C 8345 M Thompson Vol#: 662

C 8346 M Mauro Vol#: 662

C 8347 T Stilter Vol#: 662

C 8348 M Zegar Vol#: 662

C 8349 C Ross Vol#: 662

C 8350 J Haferkorn Vol#: 662

C 8351 R Adams Vol#: 662

C 8352 L Hahnler Vol#: 662

C 8353 J Hellyer Vol#: 662

C 8354 L Foster Vol#: 662

C 8355 W Perry Vol#: 662

C 8356 A Perry Vol#: 662

C 8357 L Foster Vol#: 662

C 8358 M Phillips Vol#: 662

C 8359 A Adams Vol#: 662

C 8360 D Harris Vol#: 662

C 8361 C Richards Vol#: 662

C 8362 A Page Vol#: 662

C 8363 Seemanta Vol#: 662

C 8364 L Eisman Vol#: 662

C 8365 K Tenny Vol#: 662

C 8366 E Kaufman Vol#: 662

C 8367 E Schmidt Vol#: 662

C 8368 J Yuhas Vol#: 662

C 8369 D Wilson Vol#: 662

C 8370 B Brauhgam Vol#: 662

C 8371 S Freeland Vol#: 662

C 8372 L Minton Vol#: 662

C 8373 J Roe Vol#: 662

C 8374 A Egbert Vol#: 662

C 8375 J Templeton Vol#: 662

C 8376 H Ahrens Vol#: 662

C 8377 B Mittge Vol#: 662

C 8378 C Kerner Vol#: 662

C 8379 M Rummerfield Vol#: 662

C 8380 L Gilmon Vol#: 662

C 8381 A Bhagwandin Vol#: 662

C 8382 M Anderson Vol#: 662

C 8383 T Nishball Vol#: 662

C 8384 D Casterline Vol#: 663

C 8385 J Nacy Vol#: 663

C 8386 W Rosefeld Vol#: 663

C 8387 C Mitchell Vol#: 663

C 8388 E Von Devander Vol#: 663

C 8389 M Horner Vol#: 663

C 8390 B Papciak Vol#: 663

C 8391 B Flanter Vol#: 663

C 8392 M Senett Vol#: 663

C 8393 G Gaustad Vol#: 663

C 8394 D Copeland Vol#: 663

C 8395 H Foxworthy Vol#: 663

C 8396 M Chenet Vol#: 663

C 8397 C Flick Vol#: 663

C 8398 S Christian Vol#: 663

C 8399 B Gignac Vol#: 663

C 8400 G Williams Vol#: 663

C 8401 B Todd Vol#: 663

C 8402 L Ikel Vol#: 663

C 8403 M Hall Vol#: 663

C 8404 A Petersen Vol#: 663

C 8405 E Hull Vol#: 663

C 8406 J Marsh Vol#: 663

C 8407 R Ulrich Vol#: 663

C 8408 unsigned Vol#: 663

C 8409 P McCoy Vol#: 663

C 8410 M Petzold Vol#: 663

C 8411 L Young Vol#: 663

C 8412 M Colendich Vol#: 663

C 8413 W Lapp Vol#: 663

C 8414 N Deman Vol#: 663

C 8415 M Wolk Vol#: 663

C 8416 J Dezio Vol#: 663

C 8417 P Birmingham Vol#: 663

C 8418 C Rikard Vol#: 663

C 8419 N Curtright Vol#: 663

C 8420 D Hunt Vol#: 663

C 8421 J Tate Vol#: 663

C 8422 A Evans Vol#: 663

C 8423 J Davis Vol#: 663

C 8424 M Kilpatrick Vol#: 663

C 8425 C Pancica Vol#: 663

C 8426 S Frilling Vol#: 663

C 8427 R Kerswill Vol#: 663

C 8428 A Sturman Vol#: 663

C 8429 E Rice Vol#: 663

C 8430 M Johnson Vol#: 663

C 8431 S Payne Vol#: 663

C 8432 P Carlo Vol#: 663

C 8433 M Mintz Vol#: 663

C 8434 L Staman Vol#: 663

C 8435 N Chambers Vol#: 663

C 8436 T Sabella Vol#: 663

C 8437 K Lazare Vol#: 663

C 8438 R Zink Vol#: 663

C 8439 S Connor Vol#: 663

C 8440 A Muralcami Vol#: 663

C 8441 M Arnold Vol#: 663

C 8442 B Venning Vol#: 663

C 8443 E Frilling Vol#: 663

C 8444 V Dick Vol#: 663

C 8445 R Olsen Vol#: 663

C 8446 P Davis Vol#: 663

C 8447 T Phillips Vol#: 663

C 8448 S Kinnear Vol#: 663

C 8449 M Schlamp Vol#: 663

C 8450 S Nelson Vol#: 663

C 8451 M Murrin Vol#: 663

C 8452 S McKeon Vol#: 663

C 8453 J Gonzalez Vol#: 663

C 8454 L Masters Vol#: 663

C 8455 A Florin Vol#: 663

C 8456 A. Jacobsen Vol#: 663

C 8457 I Park Vol#: 663

C 8458 L Allen Vol#: 663

C 8459 Illegible Vol#: 663

C 8460 C Murray Vol#: 663

C 8461 D Holce Vol#: 663

C 8462 P Kidd Vol#: 663

C 8463 I Galipeau Vol#: 663

C 8464 A Blackhurst Vol#: 663

C 8465 C Delgado Vol#: 663

C 8466 M Learn Vol#: 663

C 8467 H Shapiro Vol#: 663

C 8468 A Shapiro Vol#: 663

C 8469 M McAllen Vol#: 663

C 8470 A Seeger Vol#: 663

C 8471 D Smith Vol#: 663

C 8472 C Cook Vol#: 663

C 8473 A Alexander Vol#: 663

C 8474 G White Vol#: 663

C 8475 J Corliss Vol#: 663

C 8476 W Whitton Vol#: 663

C 8477 G Finkel Vol#: 663

C 8478 H Cherrington Vol#: 663

C 8479 L Hillis Vol#: 663

C 8480 P George Vol#: 663

C 8481 B Brodsky Vol#: 663

C 8482 S Kurz Vol#: 663

C 8483 P Richards Vol#: 663

C 8484 C Herbert Vol#: 663

C 8485 C Self Vol#: 663

C 8486 B Haas Vol#: 663

EMC 4051 L Avery Vol#: 662

EMC 4052 W Young Vol#: 662

EMC 4053 C Coleman Vol#: 662

EMC 4054 T Schaubella Vol#: 662

EMC 4055 Rebecca Vol#: 662

EMC 4056 L DeVaney Vol#: 662

00P-1432 Pregnancy Warning Language on OTC Nicotine Products

LET 1 HFD-1 to Lexington Law Group Vol#: 1

00P-1655 ANADA Application; Proposed product differ from appoved list

PAV 1 HFV-100 to Shotwell & Carr, Inc. Vol#: 1

01D-0033 Regulatory Submissions in Electronic Format/NDA's & IND's

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

01D-0037 Pre-Store leukocyle reduction/Blood components for transfusi

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

01M-0055 P000011; BiodivYsio AS PC Coated Stent & Delivery System

AAV 1 Biocompatibles Cardiovascular, Inc. Vol#: 1