DOCKETS ENTERED on 08/10/99
Docket Title
Number
86V-0271 Laser light show model LMS 038
VRA 8 HFZ-300 to Laser Design, Inc. Vol#: 1
89V-0300 Miami Space Transit Laser Show
VRA 4 HFZ-300 to Miami Museum of Science & Spa Vol#: 1
90S-0308 Generic Drug Speeches & Policy and Procedure Guides
M 643 HFD-7 Vol#: 44
M 644 HFD-7 Vol#: 44
91F-0228 Safe Use of Sucrose Acetate Isobutyrate As A Stabilizer
NCR 1 Vol#: 1
91V-0204 Laser Light Show
VRA 4 HFZ-300 to Mare-Bare, Inc./dba Stardust Vol#: 1
91V-0261 Variance for system 20 laser light show
VRA 4 HFZ-300 to Glenn Tonsor Associates, Inc. Vol#: 1
91V-0486 Laser Light Show
VRA 4 HFZ-300 to Museum of the Rockies Vol#: 1
92N-0139 Statement Policy: Foods Derived from New Plant Varieties
C 5770 Kathleen F Newberg Vol#: 134
C 5771 Virgil Burt Vol#: 134
C 5772 Tom Sheridan Vol#: 134
C 5773 Dan & Ingrid Toth Vol#: 134
C 5774 Tammy Stultz Vol#: 134
C 5775 George Shaler Vol#: 134
C 5776 Phyllis Ryan Vol#: 134
C 5777 Patrick Ryan Vol#: 134
C 5778 Ms J S Blackburn Vol#: 134
C 5779 Anna Allar & 15 signatures Vol#: 134
C 5780 Barbara Bateman Vol#: 134
C 5781 Pamela J Vogt Vol#: 134
C 5782 Judith C Lang Vol#: 134
C 5783 Barbara Shelp Vol#: 134
C 5784 Mr & Mrs James B Morris Vol#: 134
C 5785 Mrs Shirley Unger Vol#: 134
C 5786 Z Adams Vol#: 134
C 5787 Virginia Vanbebber Vol#: 134
C 5788 Janet Weiner Vol#: 134
C 5789 Betty Greenway Vol#: 134
C 5790 Cassandra March Vol#: 134
C 5791 Amy P Reid Vol#: 134
C 5792 Amy Bottrell Vol#: 134
C 5793 Roni A Endicott Vol#: 134
C 5794 Ron & Diane Borgmann Vol#: 134
C 5795 Dan Steinberg Vol#: 134
C 5796 L Kelly Vol#: 134
C 5797 Christopher M Thomas Vol#: 134
C 5798 Katie McWatty & 5 signatures Vol#: 134
C 5799 Brenda Clark Vol#: 134
C 5800 Caroline Gravel Vol#: 134
92P-0274 Determ Bendectin not withdrawn for safety/effective reasons
BKG 1 HFD-7 Vol#: 1
N 1 Vol#: 1
96V-0138 Laser Light Show
VRA 3 HFZ-300 to Strictly FX L.L.C. Vol#: 1
97D-0302 Consumer-Directed Broadcast Advertisements
GDL 2 Vol#: 1
NAD 2 Vol#: 1
97P-0437 Anti-Nauseant Drug was withdrawn from Approved Drug List
BKG 1 HFD-7 Vol#: 1
N 1 Vol#: 1
97V-0231 Laser light show
VRA 2 HFZ-300 to Paramount Organization, Inc. Vol#: 1
98H-0953 Civil Money Penalties; James Broderick, d/b/a 1300 Variety
LET 3 GCF-1 Vol#: 1
98H-0956 Civil Money Penalties; Gateway Service Center,d/b/a Conoco
LET 2 Office of Tobacco Programs Vol#: 1
WDL 1 GCF-1 Vol#: 1
98N-0811 Review for products in fast track drug development programs
NAL 2 Vol#: 1
S 1 Supporting Statement Vol#: 1
98N-1038 Irradiation in the production, processing, &handling of food
C 4613 Rex Reyes Vol#: 114
C 4614 Cecilia Cavalier Vol#: 114
C 4615 Al Vol#: 114
C 4616 H. McLean Vol#: 114
C 4617 Doris Lalvisberg Vol#: 114
C 4618 Alicia Forester Vol#: 114
C 4619 Emily Koel, Ph.D. Vol#: 114
C 4620 Marilyn Baciqalupi Vol#: 114
C 4621 Catherine Crawford Vol#: 114
C 4622 Gayle Hynding Vol#: 114
C 4623 Susan Watkins, M.S., MFT. Vol#: 114
C 4624 Caroline Nagle Vol#: 114
C 4625 Linda Nystedt Vol#: 114
C 4626 Andy Alpern Vol#: 114
C 4627 Betty Quick Vol#: 114
C 4628 Betty Quick Vol#: 114
C 4629 M. C. Miller Vol#: 114
C 4630 Diane Fontecchio Vol#: 114
C 4631 Tom Georginis, Ph.D. Vol#: 114
C 4632 Ted Pirro Vol#: 114
C 4633 Debra Simon Vol#: 114
C 4634 Erin Scott Vol#: 114
C 4635 Robert & Virginia Freeman Vol#: 114
C 4636 Bob Wallace Vol#: 114
C 4637 Ruth Allan Miner Vol#: 114
C 4638 Adria Reed Vol#: 114
C 4639 Marilyn Horak Vol#: 114
C 4640 Karen G. Lyke Vol#: 114
C 4641 Patti Dickinson Vol#: 114
C 4642 Tim Allen Vol#: 114
C 4643 The Center for Food Safety Vol#: 114
C 4644 Alice S. Fenn Vol#: 114
C 4645 Petrea K. Dejpour Vol#: 114
C 4646 Helen E. Mansfield Vol#: 114
C 4647 Sarah E. Steinberg Vol#: 114
C 4648 The Waldorf School Vol#: 114
C 4649 Lenore M. DeCoster Vol#: 114
C 4650 Dora Chang Vol#: 114
C 4651 Congress of the United States Vol#: 114
C 4652 illegible Vol#: 114
C 4653 Judy Spear Vol#: 114
C 4654 Josefina Alvarez Vol#: 114
C 4655 Fred Patrick Vol#: 114
C 4656 Alison Metheny Vol#: 114
C 4657 Adele Bender Vol#: 114
C 4658 Victor Owen Vol#: 114
98N-1215 Foreign Establishment Registration and Listing
NEC 1 Vol#: 1
98N-1265 Distribution of Compounded Drug Products
C 5381 Jeanne B. Cox Vol#: 164
C 5382 Tosha Weir Vol#: 164
C 5383 Sarah Scott Vol#: 164
C 5384 Bernice Wiseman Vol#: 164
C 5385 Mark J. Wiseman Vol#: 164
C 5386 Violette J. Scott Vol#: 164
C 5387 Susan S. Waller Vol#: 164
C 5388 Geraldine A. Clausen Vol#: 164
C 5389 Jerry L. Sutton Vol#: 164
C 5390 Barbara R. Levine Vol#: 164
C 5391 Catherine Schmidt Vol#: 164
C 5392 Edna Louise Lock Vol#: 164
C 5393 C. Ashley Vol#: 164
C 5394 Georgia Fannin Vol#: 164
C 5395 Wanda S. Flick Vol#: 164
C 5396 Ciari Johnson Vol#: 164
C 5397 Julie Bandwell Vol#: 164
C 5398 Sue Cates Vol#: 164
C 5399 Nancy Singleton Vol#: 164
C 5400 Jane Janson Vol#: 164
C 5401 Linda Harris Vol#: 164
C 5402 Illegible Vol#: 164
C 5403 Sally B. Hoedemaker Vol#: 164
C 5404 Joan Harper Vol#: 164
C 5405 Josephine Winsor Vol#: 164
C 5406 Enid Israelson Vol#: 164
C 5407 Paul & Faye Clay Vol#: 164
C 5408 Robert & Susan McNamee Vol#: 164
C 5409 Meredith Campbell-Bisen Vol#: 164
C 5410 Edward E. Warnick Vol#: 164
C 5411 Joanna Roy Vol#: 164
C 5412 Clare Vincent Vol#: 164
C 5413 G. Tauber Vol#: 164
C 5414 Maria Davies Vol#: 164
C 5415 Kathy Wilson Vol#: 164
C 5416 Charlene Dalluge Vol#: 164
C 5417 Ellen N. Duell Vol#: 164
C 5418 Tressa Stunson Vol#: 164
C 5419 Diana Malik Vol#: 164
C 5420 Mary J. Lau Vol#: 164
C 5421 Donna Marie Trezza Vol#: 164
C 5422 Theresa McNally Vol#: 164
C 5423 Sandra Seaman Vol#: 164
C 5424 E. S. Bryant Vol#: 164
C 5425 Harriett W. Grifo Vol#: 164
C 5426 Jeanette & Henry Huckabee Vol#: 164
C 5427 Katherine L. Roberts Vol#: 164
C 5428 Jan McCorrik Vol#: 164
C 5429 Lois Willett Vol#: 164
C 5430 Jackie Celuska Vol#: 164
C 5431 D. Annie Gish Vol#: 164
C 5432 Phoebe Lurmae Vol#: 164
C 5433 Sandra Rileg Vol#: 164
C 5434 Mary Ellen Coon Vol#: 164
C 5435 W. W. Gwyer Vol#: 164
C 5436 Danielle Catoe Vol#: 164
C 5437 Shelly McKenry Vol#: 164
C 5438 Hilda M. Iho Vol#: 164
C 5439 Cindy Harder Vol#: 164
C 5440 Medea Johnson Vol#: 164
C 5441 Jennifer I. Moore Vol#: 164
C 5442 Deanne Collins Vol#: 164
C 5443 Bette Fern Vol#: 164
C 5444 Pamela King Smith Vol#: 164
C 5445 Shirley Carpenter Vol#: 164
C 5446 Felica J. Fox Vol#: 164
C 5447 Betty Law Townsend Vol#: 164
C 5448 Ellen C. Warsaw Vol#: 164
C 5449 Sarah Shapiro Hurley Vol#: 164
C 5450 Fenneglun Rae Vol#: 164
C 5451 Ingrid Groth Vol#: 164
C 5452 Carol K. Rywich Vol#: 164
C 5453 Glenda Monge Vol#: 164
C 5454 Carol Blasi Vol#: 164
C 5455 Bronte S. L. Vol#: 164
C 5456 Susan C. Wartman Vol#: 164
C 5457 Shani M. Bush Vol#: 164
C 5458 T. Smejlet Vol#: 164
C 5459 Linda I. Adler Vol#: 164
C 5460 K. A. Jennings Vol#: 164
C 5461 Nancy C. Bryant Vol#: 164
C 5462 Elsa Baehr Vol#: 164
C 5463 Lee Moore Vol#: 164
C 5464 Louise Vopelalc Vol#: 164
C 5465 E. A. Parada Vol#: 164
C 5466 Jaimi Senkoff Vol#: 164
C 5467 Henriet Cohen Vol#: 164
C 5468 Gwendolyn M. Brand Vol#: 164
C 5469 Norma Owens Vol#: 164
C 5470 Harriet Kravitz Vol#: 164
C 5471 Anna Doherty Vol#: 164
C 5472 Xerina Lish Vol#: 164
C 5473 Marilyn L. Daniel Vol#: 164
C 5474 Sandra G. Farris Vol#: 164
C 5475 Illegible Vol#: 164
C 5476 M. Whiteside Vol#: 164
C 5477 P. Blau Vol#: 164
C 5478 Val Bier Vol#: 164
C 5479 Janis Tenbrink Vol#: 164
C 5480 Illegible Vol#: 164
C 5481 Julie Gurung Vol#: 164
C 5482 Lucinda Livingston Vol#: 164
C 5483 Michaelle Hohl Vol#: 164
C 5484 Susan Ayer Locsin Vol#: 164
C 5485 Lynn Horowitz Vol#: 164
C 5486 Eva Sari Schweber Vol#: 164
C 5487 Margaret Gallenger-Smythe Vol#: 164
98P-0203 Eliminate Forced Molting of Laying Birds
C 1766 Isabel Lanphear Vol#: 44
C 1767 Kelly Ann Minnick Vol#: 44
C 1768 Michelle Minnick Vol#: 44
C 1769 Michael Minnick Vol#: 44
C 1770 Anna Laprade Vol#: 44
C 1771 Florence Sussman Vol#: 44
C 1772 Sara Lefsyk Vol#: 44
C 1773 Janet Eisberner Vol#: 44
C 1774 Peggy Ladd Vol#: 44
C 1775 Karen Malley Vol#: 44
C 1776 Nancy A Hannan Vol#: 44
C 1777 Barbara J Ferguson Vol#: 44
C 1778 Animal Care & Welfare Vol#: 44
C 1779 Lauren O'Brien Vol#: 44
C 1780 Nancy K Lazaron Vol#: 44
C 1781 Bobbie J Henley Vol#: 44
C 1782 Jackie Fritch Vol#: 44
C 1783 Jan Vandyne Vol#: 44
C 1784 Humane Education Network Vol#: 44
C 1785 Meg Thayer Vol#: 44
C 1786 R Downing Vol#: 44
C 1787 Jean Atwood Vol#: 44
C 1788 Ms Lyn Rosen Vol#: 44
C 1789 Mr & Mrs Eugene J Piurkewski Vol#: 44
98P-1194 Withdrawal NADA Approval for Posilac - rBGH
ANS 1 HFV-12 to Vanda Gallagher Vol#: 9
C 204 Dan Steinberg Vol#: 9
C 205 Vanda Gallagher Vol#: 9
C 206 Florence Steichen Vol#: 9
C 207 Jeff & Lucy Heegaard Vol#: 9
99D-0557 Use of Nonhuman Primate Xenografts in Humans
C 280 Alwilda Munson Vol#: 16
C 281 J Iasso Vol#: 16
C 282 Lori J Rumpf Vol#: 16
C 283 Nancy L Zak Vol#: 16
99D-2406 Draft Guidance on VICH GL9 Good Clinical Practices
GDL 1 Guidance Vol#: 1
NAD 1 Vol#: 1
99F-2534 Filing of Food Additive Petition (FAP 9B4683)
NFL 1 Ciba Specialty Chemicals Corp. Vol#: 1
99F-2552 Filing of Food Additive Petition (FAP 9B4679)
NFL 1 Asahi Denka Kogyo K.K. Vol#: 1
99H-2538 Civil Money Penalty;Corso Distributing Company Inc,dba Lyon
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99N-0670 Labeling Requirements for Color Additives and Petitions
NCR 1 Vol#: 1
99N-1387 Survey of Licensed Biologics Manufacturers and Registered
NAL 1 Vol#: 1
S 1 Supporting Statement Vol#: 1
99N-2210 Reclassification of Cardiopulmonary Bypass Accessory Equipme
NPR 1 Vol#: 1
99N-2359 Summary Technical File Documents for Premarket Documentation
NAD 1 HFZ-400 Vol#: 1
REC 1 HFZ-400 Vol#: 1
REC 2 HFZ-400 Vol#: 1
SUM 1 HFZ-400 Vol#: 1
99N-2549 Cosmetic Product Voluntary Reporting Program
N 1 Vol#: 1
99P-2725 PMAs data approved prior to effective date of FDAMA prohibit
ACK 1 Vol#: 1
CP 1 HIMA Vol#: 1
99V-1935 Laser Light Show
VRA 1 HFZ-300 to HB Electronics, Inc. Vol#: 1
99V-1936
VRA 1 HFZ-215 to Entertainment Plus, Inc. Vol#: 1
99V-2095
VRA 1 HFZ-215 to Farralane Lighting, Audio & V Vol#: 1
99V-2120
VRA 1 HFZ-215 to C-Systems / Chroma Vol#: 1
99V-2246
VRA 1 HFZ-215 to Phantasm Laser Vol#: 1
99V-2727 Mobolazer ML10-200, ML10-300, ML10-300W, ML10-1000, ML10-1.0
ACK 1 HFA-305 Vol#: 1
VAR 1 Jillian's Entertainment Vol#: 1