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 June 27, 2001

TABLE OF CONTENTS

Hyper links are part of the Docket  title - not all dockets/documents are linked

[FDA DOCKETS PAGE] [FDA HOME PAGE]  [ ITEM CODES ]

 
78N-036L OTC Laxative *
99N-1852 Status reports/postmarketing studies-human drugs&biological *
00D-1598 Voluntary Labeling for Bioengineered Foods
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d *
01D-0056 Postmarketing Safety Reporting-Human Drug & Biological Prod *
01D-0058 Structure Function Rule *
01D-0185 Providing Regulatory Submissions in Electronic Format *
01D-0193 Premarket Notifications for Biological Indicators Intended *
01N-0078 Assessment of Physician & Patient Attitudes Toward Direct-to *
01N-0191 Medical Devices Classification/GHTF Study Group 1 *
01P-0209 Prescription Drug Products list amendment&approve new dosage *

78N-036L OTC Laxative

LET 189 HFD-560 to C B Fleet Company Inc Vol#: 107

97P-0441 Regulatory Status of Cholestin red yeast rice

EMC 4 M Young Vol#: 15

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

C 5290 Dr. M. Khalsa & M Oaklande Vol#: 160

C 5291 R. Garden Vol#: 160

C 5292 Sister M Clifton Vol#: 160

C 5293 M. Ehnstrom Vol#: 160

C 5294 D Ralis Vol#: 160

C 5295 D & M Wilensky Vol#: 160

C 5296 M. Curtis Vol#: 160

C 5297 J Alexander Vol#: 160

C 5298 K & J Barbett Vol#: 160

C 5299 M Anderson & D. Halsey Vol#: 160

C 5300 D & J Green Vol#: 160

C 5301 S Schwandt Vol#: 160

C 5302 M Zanders Vol#: 160

C 5303 C. Kivette Vol#: 160

C 5304 TechHouse Technology that works Vol#: 160

C 5305 C Vieira Vol#: 160

EMC 325 L Lofgren Vol#: 160

LET 9 HF-1 to Mr. Andrew Kimbrell Vol#: 160

LET 10 HF-1 to Ms. Wenonah Hauter Vol#: 160

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

C 5028 R. Glass Vol#: 157

C 5029 C Babst Vol#: 158

C 5030 M Adams Vol#: 158

C 5031 B Schmidt & J Bradley Vol#: 158

C 5032 W Pollack Vol#: 158

C 5033 J Schlegel Vol#: 158

C 5034 G Fielding Vol#: 158

C 5035 L Cameau Vol#: 158

C 5036 M Cashman Vol#: 158

C 5037 S Ryan Vol#: 158

C 5038 E. Boggs Vol#: 158

C 5039 R Poplock Vol#: 158

C 5040 H Manush Vol#: 158

EMC 2131 Bsblollipopnida Vol#: 157

EMC 2132 N Furstinger Vol#: 157

EMC 2133 J Sugg & A. Narayan Vol#: 157

EMC 2134 M Johnson Vol#: 157

EMC 2135 E Stewart Vol#: 157

EMC 2136 L Stenger Vol#: 157

EMC 2137 D Belch Vol#: 157

EMC 2138 L Parker-Rollins Vol#: 157

EMC 2139 R Meltzer Vol#: 157

EMC 2140 M Streitfeld Vol#: 157

EMC 2141 J Miller Vol#: 157

EMC 2142 T Terekhov Vol#: 157

EMC 2143 M & A Lorrig Vol#: 157

EMC 2144 J Sivey Vol#: 157

EMC 2145 M Kane Vol#: 157

EMC 2146 J Giordano Vol#: 157

EMC 2147 A Nguyen Vol#: 157

EMC 2148 J & W Warren Vol#: 157

EMC 2149 A Pang Vol#: 157

EMC 2150 D Watkins Vol#: 157

EMC 2151 R. Watkins Vol#: 157

EMC 2152 J. Frazee Vol#: 157

EMC 2153 K McBride Vol#: 157

EMC 2154 M Furlong Vol#: 157

EMC 2155 L. Smit Vol#: 157

EMC 2156 M Campbell Vol#: 157

EMC 2157 A. Cesare, M.Ad.Ed. Vol#: 157

EMC 2158 Dr. G. Campbell Vol#: 157

EMC 2159 A Potts Vol#: 157

EMC 2160 T Stoner Vol#: 157

EMC 2161 M Hay Vol#: 157

99N-1168 Public Health Impact of Foodborne Listeria Monocytogenes

EMC 2 Center for Science in the Public Interes Vol#: 1

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

C 10 Aventis Pharmaceuticals Inc Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

C 4374 Form Letter Count 918 Vol#: 341

C 4375 Form Letter Count 1,054 Vol#: 344

EMC 7078 G Soare Vol#: 318

EMC 7079 A Health Vol#: 318

EMC 7080 D Mcdonough Vol#: 318

EMC 7081 M Carnation Vol#: 318

EMC 7082 M Maracle Vol#: 318

EMC 7083 S Bayer Vol#: 318

EMC 7084 ML Gitchel Vol#: 318

EMC 7085 number not used Vol#: 318

EMC 7086 R Madrigal-Gelb Vol#: 318

EMC 7087 K Britton Vol#: 318

EMC 7088 K Rose Vol#: 318

EMC 7089 M Gilmer Vol#: 318

EMC 7090 T Gibis Vol#: 318

EMC 7091 unsigned Vol#: 318

EMC 7092 R Teague Vol#: 318

EMC 7093 G Bell Vol#: 318

EMC 7094 unsigned Vol#: 318

EMC 7095 W Divney Vol#: 318

EMC 7096 H Constant Vol#: 318

EMC 7097 J Goebeler Vol#: 318

EMC 7098 H. Pering Vol#: 318

EMC 7099 M Tam Vol#: 318

EMC 7100 B Hanna Vol#: 318

EMC 7101 R Martin Vol#: 351

EMC 7102 D Shevick, P.E. Vol#: 351

EMC 7103 D Statz Vol#: 351

EMC 7104 L Fox Vol#: 351

EMC 7105 J. May Vol#: 351

EMC 7106 D Rivers-Yowell Vol#: 351

EMC 7107 K Roth Vol#: 351

EMC 7108 B. Goldenfield Vol#: 351

EMC 7109 R. Hannah Vol#: 351

EMC 7110 J Turner Vol#: 351

EMC 7111 L Raptis Vol#: 351

EMC 7112 D Lindorff Vol#: 351

EMC 7113 number not used Vol#: 351

EMC 7114 R Steel Vol#: 351

EMC 7115 F Sawyer-Tindle Vol#: 351

EMC 7116 K Thurston Vol#: 351

EMC 7117 L. Benson Vol#: 351

EMC 7118 C Louisell / R Houston Vol#: 351

EMC 7119 M Paoletti Vol#: 351

EMC 7120 unsigned Vol#: 351


00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 4419 Illegible Vol#: 230

C 4420 Illegible Vol#: 230

C 4421 R Tuckman Vol#: 230

C 4422 J Bussiere Vol#: 230

C 4423 J O'Donnell Vol#: 230

C 4424 B Reece Vol#: 230

C 4425 Illegible Vol#: 230

C 4426 K & S Tenpas Vol#: 230

C 4427 H. Swain Vol#: 230

C 4428 H Jacobs Vol#: 230

C 4429 B Dorhofer Vol#: 230

C 4430 B. Carlson Vol#: 230

C 4431 D Weeks Vol#: 230

C 4432 F. LeClaire Vol#: 230

C 4433 K Williams Vol#: 230

C 4434 P Murphy Vol#: 230

C 4435 C Tashel Vol#: 230

C 4436 J. Hayes Vol#: 230

C 4437 C Turner Vol#: 230

C 4438 L. Reed, RN Vol#: 230

C 4439 L Mucci Vol#: 230

C 4440 J. Warwick Vol#: 230

C 4441 S Cirjan Vol#: 230

C 4442 A O'Reilly Vol#: 230

C 4443 L Thatcher Vol#: 230

C 4444 A Butz Vol#: 230

C 4445 G Spudowski Vol#: 230

C 4446 B Jacobs Vol#: 230

C 4447 M Sokolowski Vol#: 230

C 4448 D LoPresti Vol#: 230

C 4449 S & R Neff Vol#: 230

C 4450 L Bryant Vol#: 230

C 4451 B. L. Brown Vol#: 230

C 4452 Z Barker Vol#: 230

C 4453 D Blain Vol#: 230

C 4454 H Schneider Vol#: 230

C 4455 C. Pospisil Vol#: 230

C 4456 Illegible Vol#: 230

C 4457 Illegible Vol#: 230

C 4458 W. Rinehart Vol#: 230

C 4459 R. M. Peach Vol#: 230

C 4460 K Rau Vol#: 230

C 4461 Fey Vol#: 230

C 4462 B. Gamache Vol#: 230

C 4463 M. Niswander Vol#: 230

C 4464 M Herrera Vol#: 230

C 4465 D. Goslin Vol#: 230

C 4466 C Hatten Vol#: 230

C 4467 D Smith Vol#: 230

C 4468 C Booth Vol#: 230

C 4469 D. Small Vol#: 230

C 4470 J & M Bouck Vol#: 230

C 4471 T. Doyle Vol#: 230

C 4472 B Knapp Vol#: 230

C 4473 J. Light + 18 signatures Vol#: 230

C 4474 T Daley Vol#: 230

C 4475 M Wyatt Vol#: 230

C 4476 K. Hambric Vol#: 230

C 4477 V. Ponish Vol#: 230

C 4478 Expanded Learning Vol#: 230

C 4479 J Nouri Vol#: 230

C 4480 D. LeGeyt Vol#: 230

C 4481 J & D Haglund Vol#: 230

C 4482 H Finn Vol#: 230

C 4483 T Freeman Vol#: 230

C 4484 Illegible Vol#: 230

C 4485 L Dahan Vol#: 230

C 4486 T Findlan Vol#: 230

C 4487 H. Hinman Vol#: 230

C 4488 T. McLaughlin Vol#: 230

C 4489 M. Powell Vol#: 230

C 4490 D Wissnebach Vol#: 230

C 4491 Illegible Vol#: 230

C 4492 B Brooks Vol#: 230

C 4493 K Dancy Vol#: 230

C 4494 L Burns Vol#: 230

C 4495 C. Loomer Vol#: 230

C 4496 G Berry Vol#: 230

C 4497 L James Vol#: 230

C 4498 J Osborn Vol#: 230

C 4499 A Williamson Vol#: 230

C 4500 D & K Card Vol#: 230

C 4501 A Katana Vol#: 230

C 4502 W. Fox Vol#: 230

C 4503 A. Welber Vol#: 230

C 4504 A Benesch Vol#: 230

C 4505 J Aasum Vol#: 230

C 4506 G Pearce Vol#: 230

C 4507 A Henyan Vol#: 230

C 4508 S Soeleder Vol#: 230

C 4509 N Hokett Vol#: 230

C 4510 Illegible Vol#: 230

C 4511 A Pearce Vol#: 230

C 4512 A & K Estrella Vol#: 230

C 4513 R. Heltman Vol#: 230

C 4514 M Pennino Vol#: 230

C 4515 H Cryer Vol#: 230

C 4516 S Young-Burns Vol#: 230

C 4517 P Lee Vol#: 230

C 4518 S. Minick Vol#: 230

C 4519 B Burnside Vol#: 230

C 4520 N Poludnef Vol#: 230

C 4521 Illegible Vol#: 230

C 4522 E Villanuera Vol#: 230

C 4523 A Herrera Vol#: 230

C 4524 B Christian Vol#: 230

C 4525 L V Vol#: 230

C 4526 C Thompson Vol#: 230

C 4527 C Hilleary Vol#: 230

C 4528 B Gallegos Vol#: 230

C 4529 C. Tole Vol#: 230

C 4530 C Kiplinger Vol#: 230

C 4531 A Kiplinger Vol#: 230

C 4532 D Murphy Vol#: 230

C 4533 K. Kline Vol#: 230

C 4534 M. Curren Vol#: 230

C 4535 B Songer Vol#: 230

C 4536 Illegible Vol#: 230

C 4537 Illegible Vol#: 230

C 4538 Illegible Vol#: 230

C 4539 R Cote Vol#: 230

C 4540 S Coven Vol#: 230

C 4541 L Evans Vol#: 230

C 4542 J Panico Vol#: 230

C 4543 S Wilde Vol#: 230

C 4544 R McCaslin Vol#: 230

C 4545 Illegible Vol#: 230

C 4546 J Wynn Vol#: 230

C 4547 K Tomsyck Vol#: 230

C 4548 K. Sawyer Vol#: 230

C 4549 B. Weinstein Vol#: 230

C 4550 E. Bergmann Vol#: 230

C 4551 Mrs. Holton Vol#: 230

C 4552 T Makarewiez Vol#: 230

C 4553 C Belmont Vol#: 230

C 4554 D Ranciato Vol#: 230

C 4555 D Kennell, Ph.D. Vol#: 230

C 4556 C Diaz Vol#: 230

C 4557 A & C Gromiller Vol#: 230

C 4558 H Muehlmeier Vol#: 230

C 4559 B Evans Vol#: 230

C 4560 A Palf Vol#: 230

C 4561 S Spencer Vol#: 230

C 4562 M Hart Vol#: 230

C 4563 L McJunkin Vol#: 230

C 4564 J Sparks Vol#: 230

C 4565 E Pinkham Vol#: 230

C 4566 L Allen Vol#: 230

C 4567 No signature Vol#: 230

C 4568 J Adams Vol#: 230

C 4569 S Wright Vol#: 230

C 4570 M Combs Vol#: 230

C 4571 L Nitzel Vol#: 230

C 4572 P Martinez Vol#: 230

C 4573 Illegible Vol#: 230

C 4574 Illegible Vol#: 230

C 4575 Illegible Vol#: 230

C 4576 Illegible Vol#: 230

C 4577 Illegible Vol#: 230

C 4578 S Beck Vol#: 230

C 4579 D Beck Vol#: 230

EMC 7680 C Struck Vol#: 228

EMC 7681 S Harman Vol#: 228

EMC 7682 C Markman Vol#: 228

EMC 7683 L Mueller Vol#: 228

EMC 7684 D Green Vol#: 228

EMC 7685 E Metropole Vol#: 228

EMC 7686 R Dorcorsett Vol#: 228

EMC 7687 S Kittelson Vol#: 228

EMC 7688 E Friedman Vol#: 228

EMC 7689 S Kittelson Vol#: 228

EMC 7690 D Brooks Vol#: 228

EMC 7691 C Corwin Vol#: 228

EMC 7692 A Mackey Vol#: 228

EMC 7693 J Sievel Vol#: 228

EMC 7694 B Satow Vol#: 228

EMC 7695 E Derbach Vol#: 228

EMC 7696 M. Helt Vol#: 228

EMC 7697 W. Rafferty Vol#: 228

EMC 7698 K Iacobacci Vol#: 228

EMC 7699 L. Ferreri Vol#: 228

EMC 7700 E Richards Vol#: 228

EMC 7701 Lilan Vol#: 228

EMC 7702 E Sloan Vol#: 228

EMC 7703 B Hasselman Vol#: 228

EMC 7704 H Snow Vol#: 228

EMC 7705 V Chou Vol#: 228

EMC 7706 S & R Taylor Vol#: 228

EMC 7707 S Promislow Vol#: 228

EMC 7708 J Hensel Vol#: 228

EMC 7709 S Cavallo-Lay Vol#: 228

EMC 7710 J Wages Vol#: 228

EMC 7711 K Kosmeya Vol#: 228

EMC 7712 P Guittard Vol#: 228

EMC 7713 L Benson Vol#: 228

EMC 7714 B. Boroughs Vol#: 228

EMC 7715 T Malcolm Vol#: 228

EMC 7716 K Sample Vol#: 228

EMC 7717 number not used Vol#: 228

EMC 7718 S Vail Vol#: 228

EMC 7719 number not used Vol#: 228

EMC 7720 G. Greer Vol#: 228

EMC 7721 S. Killingsworth Vol#: 228

EMC 7722 A Tahotep Vol#: 228

EMC 7723 J & L Thompson Vol#: 228

EMC 7724 J Martin Vol#: 228

EMC 7725 R Brick Vol#: 228

EMC 7726 M Burton Vol#: 228

EMC 7727 K Leong Vol#: 228

EMC 7728 G. & G. Modrell Vol#: 228

EMC 7729 J Murphy Vol#: 228

EMC 7730 A Addala Vol#: 228

EMC 7731 P Otterstrom Vol#: 228

EMC 7732 I Glickman, Ph.D. Vol#: 228

EMC 7733 R & J Morris Vol#: 228

EMC 7734 J. Ryan Vol#: 228

EMC 7735 K & B Ross Vol#: 228

EMC 7736 W Richardson Vol#: 228

EMC 7737 D Yudkin Vol#: 228

EMC 7738 S Oyler Vol#: 228

EMC 7739 S & Z McCrossen Vol#: 228

EMC 7740 N. Todd Vol#: 228

EMC 7741 E Tuss & R Salisbury Vol#: 228

EMC 7742 D Smith-Webber Vol#: 228

EMC 7743 S Myers Vol#: 228

EMC 7744 A Coyote Vol#: 228

EMC 7745 S Birdsall Vol#: 228

EMC 7746 Rev. R & Rev. R Fatur Vol#: 228

EMC 7747 J Peterson, R.D. Vol#: 228

EMC 7748 W Stockwin Vol#: 228

EMC 7749 R Mickey Vol#: 228

EMC 7750 K Boyum Vol#: 228

EMC 7751 J Zamarra Vol#: 228

EMC 7752 E Chirstine Vol#: 228

EMC 7753 S Lee & G Taylor Vol#: 228

EMC 7754 M Rosemeyer Vol#: 228

EMC 7755 S Katz Vol#: 228

EMC 7756 J Moss Vol#: 228

EMC 7757 C Murphy Vol#: 228

EMC 7758 no signature Vol#: 228

EMC 7759 R. M. Beames Vol#: 228

EMC 7760 J Banks Vol#: 228

EMC 7761 A Pflieger Vol#: 228

EMC 7762 J Johnson Vol#: 228

EMC 7763 P Druide Vol#: 228

EMC 7764 P Bacon Vol#: 228

EMC 7765 L Cowls Vol#: 228

EMC 7766 S Eisele Vol#: 228

EMC 7767 D Gregg Vol#: 228

EMC 7768 W Sander Vol#: 228

EMC 7769 M Bufalry Vol#: 228

EMC 7770 K Minault Vol#: 228

EMC 7771 K Mangini Vol#: 228

EMC 7772 B First Vol#: 228

EMC 7773 B Morrigan Vol#: 228

EMC 7774 K Mangini Vol#: 228

EMC 7775 K Mangini Vol#: 228

EMC 7776 T Paquin Vol#: 228

EMC 7777 C Hahn Vol#: 228

EMC 7778 R Marconi Vol#: 228

EMC 7779 J Price Vol#: 228

EMC 7780 J Wheeler Vol#: 228

EMC 7781 M Thie Vol#: 228

EMC 7782 number not used Vol#: 228

EMC 7783 J Thomas Vol#: 228

EMC 7784 T. Tallman Vol#: 228

EMC 7785 E. Greene Vol#: 228

EMC 7786 S Lee Vol#: 228

EMC 7787 P Tronson Vol#: 228

EMC 7788 R Young Vol#: 228

EMC 7789 D Williams Vol#: 228

EMC 7790 N Wellman Vol#: 228

EMC 7791 A West, Ph.D. Vol#: 228

EMC 7792 A. Kaohelaulii Vol#: 228

EMC 7793 S Berez Vol#: 228

EMC 7794 T Mackay Vol#: 228

EMC 7795 J Lynch Vol#: 228

EMC 7796 H Paul Vol#: 228

EMC 7797 B Cundieff Vol#: 228

EMC 7798 D McLoughlin Vol#: 228


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

C 12310 T or T Angel Vol#: 765

C 12311 J Maidlow Vol#: 765

C 12312 A Mindes Vol#: 765

C 12313 B Anklin Vol#: 765

C 12314 N McGinnis Vol#: 765

C 12315 S McClung Vol#: 765

C 12316 S Gaskell Vol#: 765

C 12317 S R Klisser Vol#: 765

C 12318 S Regan Vol#: 765

C 12319 V Henderson Vol#: 765

C 12320 J Bennett Vol#: 765

C 12321 L Franklin Vol#: 765


00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d

EMC 4 Arkopharma-USA Inc Vol#: 13

00P-1276 Health Claim: Plant stanol esters and heart disease

EMC 4 Arkopharma-USA Inc Vol#:

01D-0056 Postmarketing Safety Reporting-Human Drug & Biological Prod

EMC 1 NV Organon Vol#: 2

01D-0058 Structure Function Rule

EMC 1 American Herbal Products Association Vol#: 1

01D-0185 Providing Regulatory Submissions in Electronic Format

C 1 Aventis Pharmaceuticals Inc Vol#: 1

01D-0193 Premarket Notifications for Biological Indicators Intended

C 1 AGA Linde Healthcare Vol#: 1

01N-0078 Assessment of Physician & Patient Attitudes Toward Direct-to

C 14 Advertising Federation of Fargo-Moorhead Vol#: 1

01N-0191 Medical Devices Classification/GHTF Study Group 1

C 3 Aventis Pharmaceuticals Inc Vol#: 1

01N-0219 Serono, Inc.,;Withdrawal of approval of NDA;Breokinase

N 1 Vol#: 1

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

C 176 M Boen Vol#: 7

C 177 R & D Cassani Vol#: 7

01P-0169 Access & Safe Distribution of Alosetron

C 20 Kim Carbee Vol#: 1

C 21 M J Truel Vol#: 1

01P-0209 Prescription Drug Products list amendment&approve new dosage

C 1 Kleinfeld Kaplan and Becker Vol#: 1

01P-0259 Refuse to approve tegaserod (Zelmac)

C 4 Susan Storm Vol#: 1

01V-0285 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Visual Concepts 2000 Vol#: 1