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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
Dockets Management Branch "MAY" be posted on the Internet. PLEASE DO NOT include personal identifying information, i.e. date of
birth, social security number, etc., in your correspondence. |
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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