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 September 21, 2000 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. |
95S-0117 Human Drugs Patent Term Extension & New Patents * 95S-0316 75-Day Premarket Notifications for New Dietary Ingredients * 97S-0162 30-Day Structure Function Claim Notification Letters Dietary * 00N-0930 Nominations for Working Groups: Pharmaceutical Science AC * 00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods * |
95S-0117 Human Drugs Patent Term Extension & New Patents
LST 55 List as of August 23, 2000 Vol#: 3
95S-0316 75-Day Premarket Notifications for New Dietary Ingredients
RPT 77 Novartis Consumer Health Inc Vol#: 49
97S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 5766 Feeling Fine Vol#: 45
LET 5767 Feeling Fine Vol#: 45
LET 5768 Feeling Fine Vol#: 45
LET 5769 Feeling Fine Vol#: 45
LET 5770 Feeling Fine Vol#: 45
LET 5771 Feeling Fine Vol#: 45
LET 5779 Natural Resources & Products Inter. Inc. Vol#: 45
LET 5782 Jarrow Formulas Vol#: 45
LET 5783 Jarrow Formulas Vol#: 45
LET 5784 MaxCell Bioscience, Inc. Vol#: 45
LET 5785 MaxCell Bioscience, Inc. Vol#: 45
LET 5786 MaxCell Bioscience, Inc. Vol#: 45
LET 5787 So's (USA) Company Inc. Vol#: 45
LET 5788 Natural Resources & Product Inter. Inc. Vol#: 45
LET 5789 Cognis Corporation Vol#: 45
LET 5795 Jarrow Formulas Vol#: 45
LET 5796 Jarrow Formulas Vol#: 45
LET 5797 Jarrow Formulas Vol#: 45
LET 5798 Jarrow Formulas Vol#: 45
LET 5799 Jarrow Formulas Vol#: 45
LET 5800 Lon-gev LLC Vol#: 45
LET 5801 Maharishi Ayur-Ved Products Int. Vol#: 45
LET 5802 Country Life Vol#: 45
LET 5803 MaxCell Bioscience, Inc. Vol#: 45
LET 5804 MaxCell Bioscience, Inc. Vol#: 45
LET 5805 MaxCell Bioscience, Inc. Vol#: 45
LET 5806 MaxCell Bioscience, Inc. Vol#: 45
LET 5807 MaxCell Bioscience, Inc. Vol#: 45
LET 5808 MaxCell Bioscience, Inc. Vol#:
LET 5809 MaxCell Bioscience, Inc. Vol#: 45
LET 5810 MaxCell Bioscience, Inc. Vol#: 45
LET 5811 MaxCell Bioscience, Inc. Vol#: 45
LET 5812 Longevity Nutraceutical Labs Vol#: 45
LET 5813 MaxCell Bioscience, Inc. Vol#: 45
LET 5814 Mariposa Botanicals Vol#: 45
LET 5815 Twin Laboratories, Inc. Vol#: 45
LET 5816 Twin Laboratories, Inc. Vol#: 45
LET 5817 Central Soya Company, Inc. Vol#: 45
LET 5818 Martek Biosciences Corporation Vol#: 45
LET 5819 Health Styles, Inc. Vol#: 45
LET 5820 Awareness Corporation Vol#: 45
00D-1316 Request for a Meeting to the office of new Animal Drug Eval
N 1 Vol#: 1
00M-1483 PMA Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis
AAV 1 Edwards Lifesciences LLC Vol#: 1
00M-1495 PMA Medtronic IsoMed Constant Flow Infusion System P990034
AAV 1 Medtronic Inc Vol#: 1
00M-1507 PMA FocalSeal-L Synthetic Absorbable Sealant P990028
AAV 1 Focal Inc Vol#: 1
00M-1508 PMA Apligraf (Graftskin) P950032/S016
AAV 1 Organogenesis Inc Vol#:
1
00M-1515 Medstone STS Lithotripter for treatment of gallstones
AAV 1 Medstone International
Inc Vol#: 1
00M-1517 PMA Chilli Cooled Ablation System P990054
AAV 1 Cardiac Pathways Corporation
Vol#: 1
00M-1522 PMA Matritech NMP22 Test Kit, P940035/S002
AAV 1 Martritech Inc Vol#: 1
00M-1523 PMA AIA-Pack PA, P910065/S001
AAV 1 Tosoh Medics Inc Vol#:
1
00M-1524 PMA Bayer Immuno 1 Complexed PSA Assay, P990055
AAV 1 Bayer Corporation Vol#:
1
00N-0930 Nominations for Working Groups: Pharmaceutical Science AC
C 2 Oxford GlycoSciences Ltd Vol#: 1
00N-1303 Agreement for Shipment of Devices for Sterilization
N 2 Vol#: 1
00N-1494 Class/Reclass; Restricted Devices: Analyte Specific Reagent
N 1 Vol#: 1
00N-1504 Using E-mail to Submit Info to Center for Veterinary Med
N 1 Vol#: 1
00N-1505 Notice of Intent to Slaughter for Human Food Purposes
N 1 Vol#: 1
00N-1506 Notice of Final Diposition of Animals
N 1 Vol#: 1
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods
C 6085 Sylvia Cloupp Vol#: 265
C 6086 Jim & Peter Nyeholt Vol#: 265
C 6087 Marlene Andrews Vol#: 265
C 6088 Marvin Levine Vol#: 265
C 6092 Terri Rolland Vol#: 265
C 6094 Mark Frizzell Vol#: 265
C 6096 Linda Gonnerman Vol#: 265
C 6097 Mary L. Hildebrandt Vol#: 265
C 6098 Patrick LePorte Vol#: 265
C 6099 A. F. Gilmore Vol#: 265
C 6100 Laura Childers Vol#: 265
C 6101 Ecegirl Etterman Vol#: 265
C 6103 Evelyn Prytula Vol#: 265
C 6104 Dr & Mrs M. Garfinkel Vol#: 265
C 6105 Ted & Nelisse Muga Vol#: 265
C 6107 Rebecca Gianoni Vol#: 265
C 6109 James G. Gianon Vol#: 265
C 6113 Marylou Celona Vol#: 265
C 6114 Elizabeth Tobier Vol#: 265
C 6116 E. Jennifer Chun Vol#: 265
C 6117 Jordan Dieterich Vol#: 265
C 6118 Elliott Green Vol#: 265
C 6120 Alan & Nancy Boyer Vol#: 265
C 6121 Kathryn Sermons Vol#: 265
C 6122 Shirley Jacobson Vol#: 265
C 6123 Claire Garrett Vol#: 265
C 6124 Richard Genesco Vol#: 265
C 6125 Beth Kleinman Vol#: 265
C 6127 Ron Mossellor Vol#: 265
C 6129 Grace DeWolff Vol#: 265
C 6130 Lynn MacIntosh Vol#: 265
C 6131 Greg Brelinsky Vol#: 265
C 6132 Michele Webster Vol#: 265
C 6134 Pauline Maher Vol#: 265
C 6135 Carrie O'Brien Vol#: 265
C 6136 Deni A. Gereighty Vol#: 265
C 6137 Beverly Waltes Vol#: 265
C 6141 Tiffany Knoeck Vol#: 264
C 6142 Marion Llochberg Vol#: 264
C 6143 Shirley A. Kelley Vol#: 264
C 6145 Jennifer Whittemore Vol#: 264
C 6146 Marilyn J. Perkins Vol#: 264
C 6148 Carol Pertuit Vol#: 264
C 6149 Richard Sarro Vol#: 264
C 6150 Susan DeGrane Vol#: 264
C 6151 Fred Weinstein Vol#: 264
C 6153 Morgan English Vol#: 264
C 6154 Lillian Balkin Vol#: 264
C 6158 Sylvia S. Gans Vol#: 266
C 6159 Janet L. L. David Vol#: 266
C 6160 Virginia W. Ruddell Vol#: 266
C 6162 Heidi MacNamara Vol#: 266
C 6163 Cynthia L. Peterson Vol#: 266
C 6165 Candice J. Hartman Vol#: 266
C 6167 Tony Keppelman Vol#: 266
C 6171 Jena C. Morris Vol#: 266
C 6173 Adrienne Hardesty Vol#: 266
C 6174 Deborah Reeder Vol#: 266
C 6175 Kine S. Parish Vol#: 266
C 6177 Julie Prevratil Vol#: 266
C 6178 Gordon Freedman Vol#: 266
C 6179 Mary Sudbrink Vol#: 266
C 6180 Yeardley Leonard Vol#: 266
C 6182 Catherine Frey Vol#: 266
C 6184 Dr. Annet Sheffield Vol#: 266
C 6185 Ann McCampbell Vol#: 266
C 6186 Frank Gormlie Vol#: 266
C 6187 Susan Miyanaga Vol#: 266
C 6188 Rebecca Andrees Vol#: 266
C 6189 Stephen W. Solovieff Vol#: 266
C 6190 Mary-Anne Sampson Vol#: 266
C 6192 Donald Armenta Vol#: 266
C 6193 Jennifer Willis Vol#: 266
C 6194 Jeanett Kourda Vol#: 266
C 6195 Roy & HK Ironwood Vol#: 266
C 6196 Michael Norton Vol#: 266
C 6199 Janice D. Marco Vol#: 266
C 6202 William Bakanosky Vol#: 266
C 6203 Valerie Almeida Vol#: 266
C 6204 Leah M. Slator Vol#: 266
C 6205 Irving Solomon Vol#: 266
EMC 2422 Edith Gaylord Vol#: 266
EMC 2423 Angela & Javan Oston Vol#: 266
EMC 2424 John S. Williams Vol#: 266
EMC 2425 Debra Cardoza Vol#: 266
EMC 2426 John Fisher Vol#: 266
EMC 2427 Michael Blate Vol#: 266
EMC 2428 Laurie Creed Vol#: 266
EMC 2429 James V. Manning Vol#: 266
EMC 2430 Linda Heming Vol#: 266
EMC 2431 Joy Gardner Vol#: 266
EMC 2432 Richard Muenzer Vol#: 266
EMC 2433 Linda Scheffer Vol#: 266
EMC 2434 Tammy Russell Vol#: 266
EMC 2435 Sharon Chaput Vol#: 266
EMC 2436 Linda McDade Vol#: 266
EMC 2438 Anne E. Armijo Vol#: 266
EMC 2439 Allen B. MacDiarmid Vol#: 266
EMC 2440 Sheila Netti Vol#: 266
EMC 2441 Cynthia A. Tamlyn Vol#: 266
EMC 2442 Nick Stanton Vol#: 266
EMC 2443 Cindy Kelly Vol#: 266
EMC 2444 Kathy Getchell Vol#: 266
EMC 2445 Marco Luzzi Vol#: 266
EMC 2446 Terry Kincheloe Vol#: 266
EMC 2447 Jeff Fisher Vol#: 266
EMC 2448 Natalie Brookhart Vol#: 266
EMC 2449 Toni McLaughlin Vol#: 266
EMC 2450 William Shevin Vol#: 266
EMC 2451 Thomas Klein Vol#: 266
EMC 2452 Holly Sweeney Vol#: 266
EMC 2453 Eileen Wise Vol#: 266
EMC 2454 Pamela Emes Vol#: 266
EMC 2455 Clay Turnbull Vol#: 266
EMC 2456 Laura Harris Vol#: 266
EMC 2458 Lee Swensson Vol#: 266
EMC 2459 Joseph Pierro Vol#: 266
EMC 2460 Barbara Jones Vol#: 266
EMC 2461 Stephen Crawford Vol#: 266
EMC 2462 Josh & Tammy Salans Vol#: 266
EMC 2463 George Greer Vol#: 266
EMC 2465 Christina Root Vol#: 266
EMC 2466 Laura Weston Vol#: 266
EMC 2467 Marilyn Ison Vol#: 266
EMC 2468 Michael Polidori Vol#: 266
EMC 2469 Penelope Moghe Vol#: 266
EMC 2471 K. J. Cummings Vol#: 266
EMC 2472 Yigael van der Hoeven Vol#: 266
EMC 2473 Lowell Montgomery Vol#: 266
EMC 2474 Anne-Marie Dalton Vol#: 266
EMC 2475 Marshall Chrostowskii Vol#: 266
EMC 2476 Warren W Epman Vol#: 266
EMC 2477 Richard Spitzer Vol#: 266
EMC 2479 Jane McCloskey Vol#: 266
EMC 2480 Linda Meisinger Vol#: 266
EMC 2481 Jon Fiebelkorn Vol#: 266
EMC 2482 Deborah Chamberlain Vol#: 266
EMC 2483 John G. Root Jr Vol#: 266
EMC 2485 Douglas Lufkin Vol#: 266
EMC 2486 John Artley Vol#: 266
EMC 2487 Drew Peterson Vol#: 266
EMC 2489 Delica Barrow Vol#: 266
EMC 2490 Heidi Schweder Vol#: 266
EMC 2491 Joan Mazurek Vol#: 266
EMC 2492 Dominic DeJoseph Vol#: 266
EMC 2493 Diana Knowles Vol#: 266
EMC 2494 Denette Blackwell Vol#: 266
EMC 2496 Rich Dalton Vol#: 266
EMC 2497 Richard Bodane Vol#: 266
EMC 2498 Irene McCormick Vol#: 266
EMC 2500 Nancy Hirschfeld Vol#: 266
EMC 2501 Deborah Young MD Vol#: 266
EMC 2503 C. Lee Stallings Vol#: 266
EMC 2504 John Pletting Vol#: 266
EMC 2505 Phil Carmody Vol#: 266
EMC 2506 Myrna Kitchens Vol#: 266
EMC 2507 Kellie Williamson Vol#: 266
EMC 2509 Renate Van Hintum Vol#: 266
EMC 2510 Kathy Daughterty Vol#: 266
EMC 2511 Paul Hubbard Vol#: 266
EMC 2512 Richard Froschheiser Vol#: 266
EMC 2513 Barbara A. Patrick Vol#: 266
EMC 2514 Jerome Mittelman Vol#: 266
EMC 2515 Ann-Elizabeth Barnes Vol#: 266
EMC 2516 Doreen Miller Vol#: 266
EMC 2517 Hollis Martin Vol#: 266
EMC 2518 William Bowker Vol#: 266
EMC 2519 Tim The White Vol#: 266
EMC 2520 David Medvigy Vol#: 266
EMC 2521 Shari Wilschutte Vol#: 266
EMC 2522 Kelli Hunziker Vol#: 266
EMC 2523 Donna Milam Vol#: 266
EMC 2525 Ramachandran Subramanian Vol#: 266
EMC 2526 Maryanne Desharnais Vol#: 266
EMC 2527 Christine McCullum Vol#: 266
EMC 2528 Peter J. Smith Vol#: 266
EMC 2530 Brad Parsons Vol#: 266
EMC 2531 Bill Schoenbart Vol#: 266
EMC 2532 Jean Edwards Vol#: 266
EMC 2533 Mattia Monetti Vol#: 266
EMC 2534 Michael Robson Vol#: 266
EMC 2535 Orestes Anastasia Vol#: 266
EMC 2536 Rachel Sanchez Vol#: 266
EMC 2537 B. D. Stillion Vol#: 266
EMC 2538 Teresa Costanzo Vol#: 266
EMC 2539 Luca Nikodimovich Vol#: 266
EMC 2540 Crystal Tuggle Vol#: 266
EMC 2541 The Griswolds Vol#: 266
EMC 2542 R. B. Milroy Vol#: 266
EMC 2543 Antony DiGiovanni Vol#: 266
EMC 2544 Marcella Varnado Vol#: 266
EMC 2545 Constance Pride Vol#: 266
EMC 2546 Rebecca Rasmussen Vol#: 266
EMC 2547 Paola Letardi Vol#: 266
EMC 2548 Stephanie Jennings Vol#: 266
EMC 2549 Rita Andersen Vol#: 266
EMC 2550 Nick Hamilton Vol#: 266
EMC 2552 Robert Muniz Vol#: 266
EMC 2553 Kevin Gunderman Vol#: 266
EMC 2555 Dr Arnold Sutterlin Vol#: 266
EMC 2556 Maria Stadtmueller Vol#: 266
EMC 2557 Carol Walker Vol#: 266
EMC 2558 Bhavik Patel Vol#: 266
EMC 2559 James Wolff Vol#: 266