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 25, 2001 TABLE OF CONTENTS Hyper links are part of the Docket title - not all dockets/documents are linked. NOTE: Documents received by the
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91N-0101 Antioxidant Vitamins & Cancer,Hlth. Claims & Label Statement
LET 7 HFS-800 to Emord & Associates P C Vol#: 47
REF 4 REFERENCES Vol#: 47
92S-0251 Electronic Submissions; Establishment of Public Docket
M 13 CVM, CFR 11.2(b)(2) Guidance for Ind.on Vol#: 1
00D-1598 Voluntary Labeling for Bioengineered Foods
C 2758 Candace Boheme Vol#: 261
C 2759 Sally Burnell Vol#: 261
C 2760 Toddy Perryman Vol#: 261
C 2761 Kimberly R. Anderson Vol#: 261
C 2762 Michelle TenEych Vol#: 261
C 2763 Diane Kilbourne Vol#: 261
C 2764 Leslie Arnold Vol#: 261
C 2765 Harriet Elfring Vol#: 261
C 2766 Dr. George J. Muench Vol#: 261
C 2767 D D Vol#: 261
C 2768 Ramlah Lauritsen Vol#: 261
C 2770 Robert R. Beck Vol#: 261
C 2771 Nancy L. Danneker Vol#: 261
C 2772 Adam M. Briggs Vol#: 261
C 2773 Mr. Peter Shank Vol#: 261
C 2774 Dereth Giance Vol#: 261
C 2775 Paul Rosenblatt Vol#: 261
C 2778 Virginia Rush Vol#: 261
C 2779 Elaine S. Fike Vol#: 261
C 2780 Dorothy Leone Vol#: 261
C 2781 Mrs. Rose Palladino Vol#: 261
C 2782 Ione Dusinberre Vol#: 261
C 2783 James Sheldon Vol#: 261
C 2784 Theodore Odell Vol#: 261
C 2785 Mr. Jeremiah Higgs Vol#: 261
C 2786 Bryan Halvacker Vol#: 261
C 2789 Carl Staueil, P.E Vol#: 261
C 2790 Victoria Juras & Evan Gallas Vol#: 261
C 2791 Katherine Latendresse, R.D. Vol#: 261
C 2793 Dolores McClian Vol#: 261
C 2794 Marian Hollander Vol#: 261
C 2797 Adrienne Scott Warner Vol#: 261
C 2803 Jaime Hronich Vol#: 261
C 2804 Phyllis Wolff Vol#: 261
C 2806 Susan Hesselgrave Vol#: 261
C 2807 Dr. Elaine Wellin Vol#: 261
C 2808 Nancy L. Danneker Vol#: 261
C 2809 John R. Danneker Vol#: 261
C 2811 Linda Tompkins Vol#: 261
C 2814 Christine O. Hall Vol#: 261
C 2816 James D. Johnson Vol#: 261
C 2817 Katherine Gott Vol#: 261
C 2818 George E. Everett Vol#: 261
C 2820 Michelle E. Budny Vol#: 261
C 2822 Christian & Christina Martin Vol#: 261
C 2826 Beatrice Boles Vol#: 261
C 2831 Michelle Collins Vol#: 261
C 2832 Sara Newton Juarez Vol#: 261
C 2836 Alberta Affori Vol#: 261
C 2842 Theresa Winehall Vol#: 263
C 2844 Robert H. Friedman Vol#: 263
C 2846 Everett T. Jenkins Vol#: 263
C 2850 Francesca Luone Vol#: 263
C 2854 Karstein Creightney Vol#: 263
C 2855 Jennifer Tobin Vol#: 263
C 2856 Cory Greenfield Vol#: 263
C 2857 Canardia Reid Vol#: 263
C 2859 Marjorie Ewan Vol#: 263
C 2862 Maisie Crelman Vol#: 263
C 2867 Carolee Barrus Vol#: 263
C 2869 Brian Greenfield Vol#: 263
C 2870 Steven Hether Vol#: 263
C 2871 Joanne Forman Vol#: 263
C 2872 Greta C. Keleher Vol#: 263
C 2873 Chamber of Commerce of the United States Vol#: 263
C 2874 Bill Davidson Vol#: 263
C 2875 Martin J. Dobring Vol#: 263
C 2877 Andrea Peterson Vol#: 263
C 2878 Kathy Gilstrap Vol#: 263
C 2880 Raphael Fisher Vol#: 263
C 2881 Fawn Marie Nozn Vol#: 263
C 2882 Chaparral Ireland Vol#: 263
C 2883 Suzanne S. Neill Vol#: 263
C 2885 Dearbhla Molloy Vol#: 263
C 2886 June Maselbas Vol#: 263
C 2888 Dorrie Berkowitz Vol#: 263
C 2889 Edith Galloway Vol#: 263
C 2890 Heather Anderson Vol#: 263
C 2892 Jeffrey R. McIntyre Vol#: 263
C 2893 Jacqueline Yourch Vol#: 263
C 2894 Marilyn Grant Vol#: 263
C 2896 Kevin Barrett Vol#: 263
C 2897 Anne-Marie S. Pyles Vol#: 263
C 2898 Judith E. Bishop Vol#: 263
C 2900 Christine Gillund Vol#: 263
C 2902 Ms. Gloria Semonian Vol#: 263
C 2903 Chris Passmann Vol#: 263
C 2905 Paulette Glassman Vol#: 263
C 2907 Suzanne S. Neill Vol#: 263
C 2909 Craig Eyerick Vol#: 263
C 2911 Rev Barbara Clearbridge Vol#: 263
C 2912 Mr. & Mrs. G. Lofts Vol#: 263
C 2914 Grocery Manufacturers of America Vol#: 263
C 2915 Jean R. Moehring Vol#: 263
C 2916 Alvah MacWilliams Vol#: 263
C 2918 Katherine D. Long Vol#: 263
C 2919 Vivian Warkentin Vol#: 263
C 2920 National Restaurant Association Vol#: 263
C 2922 Dr. James Oleskevich, DDS Vol#: 263
C 2923 Michael Grosh Vol#: 263
C 2925 Gerber Products, Co. Vol#: 263
C 2926 American Crop Protection Association Vol#: 263
C 2927 National Food Processors Association Vol#: 263
EMC 4297 Crystal Cox Vol#: 259
EMC 4298 Darleen Lum Vol#: 259
EMC 4299 Mark Elliott Vol#: 259
EMC 4300 Douglas Campbell Vol#: 259
EMC 4301 Don Bleier Vol#: 262
EMC 4302 Alicia Gronke Vol#: 262
EMC 4303 Tommeliam Bradaigh Vol#: 262
EMC 4305 Colleen Curtis Vol#: 262
EMC 4306 Donna Germano Vol#: 262
EMC 4309 Alla Blanca-White Vol#: 262
EMC 4310 Timothy Ford Vol#: 262
EMC 4311 David Thomas Vol#: 262
EMC 4312 Gwen Overturf Vol#: 262
EMC 4313 Cynthia Orbik Vol#: 262
EMC 4314 Corrie Navis Vol#: 262
EMC 4315 Myra Perala Vol#: 262
EMC 4316 Michele Chavez-Pardini Vol#: 262
EMC 4317 Andrew Bruck Vol#: 262
EMC 4318 Andrew Schuler Vol#: 262
EMC 4319 Rachael Tompkins Vol#: 262
EMC 4320 Steven Dunlap Vol#: 262
EMC 4321 Pamela Rico Vol#: 262
EMC 4322 Eben Stewart Vol#: 262
EMC 4323 Cindy Mershon Vol#: 262
EMC 4324 Wendy Alcantara Vol#: 262
EMC 4325 Kurtis Helm Vol#: 262
EMC 4326 Tanya Beilke Vol#: 262
EMC 4327 Donna Coyle Vol#: 262
EMC 4328 Allison Brim Vol#: 262
EMC 4329 Deborah Toy Vol#: 262
EMC 4330 Blair Phillips Vol#: 262
EMC 4331 Elizabeth Costello Vol#: 262
EMC 4334 Rory Pierce Vol#: 262
EMC 4335 Stephen Allen Vol#: 262
EMC 4336 Laurie Ashley Vol#: 262
EMC 4337 Erin Cordray Vol#: 262
EMC 4338 Robert Krueger Vol#: 262
EMC 4339 Lynda Crocker Vol#: 262
EMC 4340 Lynda Crocker Vol#: 262
EMC 4341 Katharine Gale Vol#: 262
EMC 4342 Willow Rosenthal Vol#: 262
EMC 4343 Katharine Gale Vol#: 262
EMC 4344 Kristina Gericke Vol#: 262
EMC 4345 Gladys Cotezz Vol#: 262
EMC 4347 David Gould Vol#: 262
EMC 4348 Nancy Knoll Vol#: 262
EMC 4349 Connie Hansen Vol#: 262
EMC 4350 Therese Scott Vol#: 262
EMC 4351 Lydia Straus-Edwards Vol#: 262
EMC 4352 Number not used Vol#: 262
EMC 4353 Jennifer Marx Vol#: 262
EMC 4354 Nora Roman, R.N. Vol#: 262
EMC 4355 Janette Gillean Vol#: 262
EMC 4356 Sherry Benson Vol#: 262
EMC 4357 Jonathan Brown Vol#: 262
EMC 4358 Number not used Vol#: 262
EMC 4359 William Epp Vol#: 262
EMC 4360 D. M. Jiricek Vol#: 262
EMC 4361 Linda Whitworth-Reed Vol#: 262
EMC 4362 Jason Osburn Vol#: 262
EMC 4363 Michael Lopes Vol#: 262
EMC 4364 Michael Shannon Vol#: 262
EMC 4365 Jennifer Burns Vol#: 262
EMC 4366 Thomas Mackey Vol#: 262
EMC 4367 Thomas Mackey Vol#: 262
EMC 4369 Karl Walker Vol#: 262
EMC 4370 Ron Warsher Vol#: 262
EMC 4371 Jeff Henderson Vol#: 262
EMC 4372 Walt Bernard Vol#: 262
EMC 4374 Rachel C. Kelly Vol#: 262
EMC 4375 John Grater Vol#: 262
EMC 4377 Elvira A. Bowman-Walklin Vol#: 262
EMC 4378 Paul Edwards Vol#: 262
EMC 4379 Renee Yates Vol#: 262
EMC 4380 Anna Guldager Vol#: 262
EMC 4381 Suzanne Feldberg Vol#: 262
EMC 4382 August Vargas Vol#: 262
EMC 4383 Steven Strouth Vol#: 262
EMC 4384 Robert J. Derby, Jr. Vol#: 262
EMC 4386 Spencer Blackman Vol#: 262
EMC 4388 Michael Janson Vol#: 262
EMC 4389 Kevin Kautz Vol#: 262
EMC 4390 Garry Montgomery Vol#: 262
EMC 4391 Jamie Billings Vol#: 262
EMC 4393 Andrea Beaman Vol#: 262
EMC 4394 Jnana Sivananda Vol#: 262
EMC 4395 Robes London Vol#: 262
EMC 4396 David Barouth Vol#: 262
EMC 4397 Caroline Ostrow Vol#: 262
EMC 4398 Sharon Tucker Vol#: 262
EMC 4399 Maurella Cunningham Vol#: 262
EMC 4400 Jennifer Bramel Vol#: 262
EMC 4401 Linda T. Dewing Vol#: 262
EMC 4402 Lisa Griffith Vol#: 262
EMC 4403 Christine Visscher Vol#: 262
EMC 4404 Ferris Haddad Vol#: 262
EMC 4405 Christine Visscher Vol#: 262
EMC 4406 Ferris Haddad Vol#: 262
EMC 4407 Barbara Fix Vol#: 262
EMC 4409 Jenette Settle Vol#: 262
EMC 4410 Linda Bodne Vol#: 262
EMC 4411 Diana Roach Vol#: 262
EMC 4412 Damien Luyet Vol#: 262
EMC 4414 Christopher Kauffmann Vol#: 262
EMC 4415 Olivia du Mosch Vol#: 262
EMC 4417 Roberto Milani Vol#: 262
EMC 4418 Lilian Elias Vol#: 262
EMC 4419 Jim Hollister Vol#: 262
EMC 4420 Eddie Ortiz Vol#: 262
EMC 4422 Steven Murray Vol#: 262
EMC 4424 Bill Polzin Vol#: 262
EMC 4425 F. Jean Van Meter Vol#: 262
EMC 4426 Marcy Roberts Vol#: 262
EMC 4427 Sandra L. Hugill Vol#: 262
EMC 4428 Colleen McGee Vol#: 262
EMC 4429 Matilda Aracne Vol#: 262
EMC 4431 Steven Lowrie Vol#: 262
EMC 4434 Karen Ulrich Vol#: 262
EMC 4435 Shane Warnick Vol#: 262
EMC 4436 Number not used Vol#: 262
EMC 4437 Nathan Bokil Vol#: 262
EMC 4438 Nathan Bokil Vol#: 262
EMC 4439 Michele Crossan Vol#: 262
EMC 4440 Lynda Liptak Vol#: 262
EMC 4441 Gerry Foley Vol#: 262
EMC 4442 Noelle Douglas Vol#: 262
EMC 4443 Richard L. Peters Vol#: 262
EMC 4444 Peggy Monahan Vol#: 262
EMC 4445 Holly Beckley Vol#: 262
EMC 4446 Robbie Stair Vol#: 262
EMC 4447 Cynthia Hagen Vol#: 262
EMC 4448 Cyndy Wilson Vol#: 262
EMC 4449 Mark Gallin Vol#: 262
EMC 4450 Ms. Andrea Thomas Vol#: 262
EMC 4452 Number not used Vol#: 262
EMC 4453 David Archambeau Vol#: 262
EMC 4454 Jessica Krienert Vol#: 262
EMC 4455 Cyndy Wilson Vol#: 262
EMC 4456 Number not used Vol#: 262
EMC 4457 Cris Nelson Vol#: 262
EMC 4459 Mitch Altman Vol#: 262
EMC 4460 Pheebee Njudu Vol#: 262
EMC 4461 Charles Christensen Vol#: 262
EMC 4462 Kimberly Rusher Vol#: 262
EMC 4463 Dennis Flatt Vol#: 262
EMC 4464 Steve Leibowitz Vol#: 262
EMC 4466 Melissa M. Glick Vol#: 262
EMC 4467 Lori Pherigo Vol#: 262
EMC 4468 Lori Pherigo Vol#: 262
EMC 4469 Mike Cannon Vol#: 262
EMC 4470 Jennifer Jackson Vol#: 262
EMC 4471 Beverly McFarland Vol#: 262
EMC 4472 Leilani Mullen Vol#: 262
EMC 4473 Jennifer Smith Vol#: 262
EMC 4474 Aaron E. Matyjasik Vol#: 262
EMC 4475 Elisa R. Cohen Vol#: 262
EMC 4477 Geraldine Souzis Vol#: 262
EMC 4478 Richard R. Rathmann Vol#: 262
EMC 4480 Anna Creissen Vol#: 262
EMC 4481 Steve Pollack Vol#: 262
EMC 4482 Steve Pollack Vol#: 262
EMC 4483 Richard Swartz Vol#: 262
EMC 4484 Jessica McCafferty Vol#: 262
EMC 4485 Shane Warnick Vol#: 262
EMC 4486 Julie Maerker Vol#: 262
EMC 4487 Nancy Lewis Vol#: 262
EMC 4488 Ms. Jennifer Anne Moe Vol#: 262
EMC 4489 Carol Ekarius Vol#: 262
EMC 4490 number not used Vol#: 262
EMC 4491 number not used Vol#: 262
EMC 4494 Zita Nielsen Vol#: 262
EMC 4495 Tonya Rimbey Vol#: 262
EMC 4497 Travis Moose Vol#: 262
EMC 4498 Marchette Du Bois Vol#: 262
EMC 4499 Marian Allen Vol#: 262
EMC 4502 Scott Gillentine Vol#: 264
EMC 4503 Sarah Adams Vol#: 264
EMC 4504 Roger M. Bondy Vol#: 264
EMC 4505 Meredith McCarty Vol#: 264
EMC 4507 Rita L. Merk Vol#: 264
EMC 4508 Laura Simon Vol#: 264
EMC 4509 Carol Coates Vol#: 264
EMC 4510 George Kalich Vol#: 264
EMC 4511 Cynthia Robinson-Ingalls Vol#: 264
EMC 4512 Rita Wilder Vol#: 264
EMC 4514 number not used Vol#: 264
EMC 4515 Judith McCormack Vol#: 264
00E-1346 Patent Extension Keppra, No. 4,943,639
LET 2 HFD-005 to US Patent & Trademark Office Vol#: 1
00E-1347 Patent Extension AVELOX
LET 2 HFD-005 to US Patent & Trademark Office Vol#: 1
00E-1608 Patent Extension for Minimed 2007, No. 4,373,527
LET 2 HFD-005 to US Patent & Trademark Office Vol#: 1
00P-1340 Withdrawn of ROWASA Suppositories
N 1 Vol#: 1
01D-0056 Postmarketing Safety Reporting-Human Drug & Biological Prod
C 18 Novartis Pharmaceuticals Corp Vol#: 2
C 19 American Medical Informatics Assn Vol#: 2
C 20 Abbott Laboratories Vol#: 2
01D-0086 Disclosing information; Open CBER Mtgs/Testing or Approvals
C 2 Abbott Laboratories Vol#: 1
C 3 Bristol-Myers Squibb Vol#: 1
EMC 1 Novartis Pharmaceuticals Vol#: 1
01E-0029 Patent Extension for Trileptal, No. 4,559,174
LET 2 HFD-005 to US Patent & Trademark Office Vol#: 1
01E-0089 Kaletra, Patent Extension Application No.5,886,036
LET 2 HFD-005 to US Patent & Trademark Office Vol#: 1
01E-0090 Abreva, Patent Extension Application No.4,874,794
LET 2 HFD-005 to US Patent & Trademark Office Vol#: 1
01E-0091 Argatroban, Patent Extension Application No.5,214,052
LET 2 HFD-005 to US Patent & Trademark Office Vol#: 1
01E-0092 Rescula, Patent Extension Application No. 5,221,763
LET 2 HFD-005 to US Patent & Trademark Office Vol#: 1
01E-0097 ReFacto, Patent Extension Application No. 4,868,112
LET 2 HFD-005 to US Patent & Trademark Office Vol#: 1
01E-0098 TNKase, Patent Extension Application No.5,385,732
LET 2 HFD-005 to US Patent & Trademark Office Vol#:
01E-0100 Advair Diskus, Patent Extension Application No.5,270,305
LET 2 HFD-005 to US Patent & Trademark Office Vol#: 1
01H-0065 Civil Money Penalty for First Check Home Drug Test Decives
MO 3 GCF-1 Vol#: 1
01P-0244 Investigate the Use of Polyethylene Glycol in Children
01P-0245 Determination that Disulfiram was withdrawn for reasons othe
CP 1 Sidmak Laboratories, Inc. Vol#: 1
01V-0246 Variance application for nLighten Parallel Fiber Optic Trans
ACK 1 HFA-305 Vol#: 1
VAR 1 W.L. Gore & Associates, Inc. Vol#: 1
01V-0247 Laser Light Show
ACK 1 HFA-305 Vol#: 1
VAR 1 Carolina Bowling Center Vol#: 1