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]

DOCKETS ENTERED on September 30, 1999

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

[FDA DOCKETS PAGE][FDA HOME PAGE]

90S-0308 Generic Drug Speeches & Policy and Procedure Guides *
94P-0043 Establish common or usual name for blue crab *
95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability *
96N-0135 Protein Derived from Ruminants Prohibited in Ruminant Feed *
96P-0243 Adopt Bioequivalency Requirements for Propafenone Tablets *
97N-0135 OTC Test Sample Collection Systems*
98D-0077 Treatment of osteoarthritis/drugs, devices and biological pt *
98N-0313 Sugeons's and Patient Examination Gloves Reclassification *
98N-0673 Revisions to Requirements to Blood,Blood Components & Plasma
98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell *
98P-0683 Soy Protein Containing Products*
99D-1454 Nasal spray, inhalation solution, suspension&spray drug prod *
99D-1738 Bioavilability & Bioequivalence Studies for Nasal Aerosols *
99N-1307 Preliminary Regulatory Impact Analysis and Initial Regulatoy *
99N-1591 Animal Drug Availabililty Act; Veterinary Feed Directive *
99N-2151 New Animal Drug Applications; Sheep as a Minor Species *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-1589 Stay effective date of approval for NDA 20-932 Roxicodone *
99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast *
99P-2554 Administrative Action Against E. Excel International *
99P-3029 Health Claim: Folic Acid, Vitamin B6 etc & Vascular Disease *
99V-4237 Request for Lazer Light Show*

90S-0308 Generic Drug Speeches & Policy and Procedure Guides

M 646 HFD-7 Vol#: 44

94P-0043 Establish common or usual name for blue crab

C 11 Garland F. Fulcher Seafood Company, Inc Vol#: 1

95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability

LET 45 The Honorable J. Dennis Hastert Vol#: 281

96N-0135 Protein Derived from Ruminants Prohibited in Ruminant Feed

C 1695 Mrs. Charles W. Ford Vol#: 86

96P-0243 Adopt Bioequivalency Requirements for Propafenone Tablets

SUP 1 Knoll Pharmaceutical Company Vol#: 2

96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs

C 393 Catherine Harding Vol#: 15

C 394 Mari Eugert Vol#: 15

C 395 Shay Stanley Vol#: 15

C 396 Sean Klonaris Vol#: 15

C 397 Darlene Dahl Vol#: 15

C 398 Animals Activists of Central Florida Vol#: 15

C 399 Beverly A. Vol#: 15

C 400 I. B. Sinclair Law Offices Vol#: 15

C 401 G. E. Friend Vol#: 15

C 402 Michael Baumier Vol#: 15

C 403 Staci-Lee Sherwood Vol#: 15

C 404 no signature Vol#: 15

C 405 Marie A. Long Vol#: 15

C 406 Edward Castellano Vol#: 15

C 407 Carol Sue James Vol#: 15

C 408 Claudia Bauer Vol#: 15

C 409 Joseph Mann Vol#: 15

C 410 Kathy Peirce Vol#: 15

C 411 Mariann Sullivan Vol#: 15

97N-0074 President's National Food Safety Initiative

C 109 Karrie Holt Vol#: 10

C 110 Patricia Holt-Billey Vol#: 10

97N-0135 OTC Test Sample Collection Systems

C 2 McKenna & Cuneo, L.L.P. Vol#: 1

97P-0197 Require that warning labels about risks of salmonella enteri

C 394 Catherine Harding Vol#: 14

C 395 Mari Eugert Vol#: 14

C 396 Shay Stanley Vol#: 14

C 397 Sean Klonaris Vol#: 14

C 398 Darlene Dahl Vol#: 14

C 399 Animals Activists of Central Florida Vol#: 14

C 400 Beverly A. Vol#: 14

C 401 I. B. Sinclair Law Offices Vol#: 14

C 402 G. E. Friend Vol#: 14

C 403 Michael Baumier Vol#: 14

C 404 Staci-Lee Sherwood Vol#: 14

C 405 no signature Vol#: 14

C 406 Marie A. Long Vol#: 14

C 407 Edward Castellano Vol#: 14

C 408 Carol Sue James Vol#: 14

C 409 Claudia Bauer Vol#: 14

C 410 Joseph Mann Vol#: 14

C 411 Kathy Peirce Vol#: 14

C 412 Mariann Sullivan Vol#: 14

98D-0077 Treatment of osteoarthritis/drugs, devices and biological pt

C 16 R. Wayne Frost, Pharm. D., J. D. Vol#: 1

98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding;

C 157 Lucio, Mandler, Bronstein, Garbett Vol#: 19

98N-0313 Sugeons's and Patient Examination Gloves Reclassification

C 2 Jane W. Hannon, RDH Vol#: 5

C 3 Medical College of Wisconsin Vol#: 5

98N-0562 Civil Money Penalties; Rajaram K Matkari

LET 3 GCF-1 Vol#: 1

NH 1 GCF-1 Vol#: 1

98N-0673 Revisions to Requirements to Blood,Blood Components & Plasma

C 2 Blood Bank of San Bernardino Vol#: 1

98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell

LINKED COMMENTS (THROUGH C 411) DUPLICATE THOSE FOR 96P-0418 AND 97P-0917 ABOVE

C 393 Catherine Harding Vol#: 18

C 394 Mari Eugert Vol#: 18

C 395 Shay Stanley Vol#: 18

C 396 Sean Klonaris Vol#: 18

C 397 Darlene Dahl Vol#: 18

C 398 Animals Activists of Central Florida Vol#: 18

C 399 Beverly A. Vol#: 18

C 400 I. B. Sinclair Law Offices Vol#: 18

C 401 G. E. Friend Vol#: 18

C 402 Michael Baumier Vol#: 18

C 403 Staci-Lee Sherwood Vol#: 18

C 404 no signature Vol#: 18

C 405 Marie A. Long Vol#: 18

C 406 Edward Castellano Vol#: 18

C 407 Carol Sue James Vol#: 18

C 408 Claudia Bauer Vol#: 18

C 409 Joseph Mann Vol#: 18

C 410 Kathy Peirce Vol#: 18

C 411 Mariann Sullivan Vol#: 18

C 412 Bonnie Blitstein Vol#: 18

C 413 Susan Bleiberg Vol#: 18

C 414 Sylvia Shivy Vol#: 18

C 415 Jenny Torres Vol#: 18

C 416 Kerry Masters Vol#: 18

C 417 Fredrick & Lynette Eliton Vol#: 18

C 418 Winnifred Reuter Vol#: 18

C 419 Suzanne Martin Vol#: 18

C 420 Mimi Taylor Vol#: 18

C 421 Art & Design Vol#: 18

C 422 Ronni F. Feigenbaum Vol#: 18

C 423 Patricia DeToffol Vol#: 18

C 424 Linda Toombs Vol#: 18

C 425 Kevin M. Crupi Vol#: 18

C 426 John & Suzanne Carlson Vol#: 18

C 427 Tammy Plover Vol#: 19

C 428 Nancy Pennington Vol#: 19

C 429 Sara Dorenkamp Vol#: 19

C 430 Nuda Sarcone Vol#: 19

C 431 Rosemarie Woods Vol#: 19

C 432 Eileen Adams Vol#: 19

C 433 Eileen W. & Mark D. Johnson Vol#: 19

C 434 Mike Staton Vol#: 19

C 435 Neil A. Coppola Vol#: 19

C 436 Mrs. Jennifer L. Hald Vol#: 19

C 437 Animal Welfare Institute Vol#: 19

C 438 Gayle Harris Birk Vol#: 19

C 439 Cassie L. Carothers Vol#: 19

C 440 Robyn Evans Vol#: 19

C 441 Karen Faxon Vol#: 19

C 442 Rebecca Ott Vol#: 19

C 443 S. M. Hummel Vol#: 19

C 444 Carol Lawrence Vol#: 19

C 445 VIVA, Vegetarians Intl. Voice for Animal Vol#: 19

C 446 Glenn McKinney Vol#: 19

C 447 Teresa G. Rojas Vol#: 19

C 448 William John Divney Vol#: 19

C 449 Steven D. Gruber Vol#: 19

C 450 Michele Malchisky Vol#: 19

C 451 Anthony Ficcio Vol#: 19

C 452 Katherine Najwer-Coyle Vol#: 19

C 453 Constance Dutton Vol#: 19

C 454 Jean Allison Thaler Vol#: 19

C 455 Gail Hale Vol#: 19

C 456 Carmen Arreola Vol#: 19

C 457 A. Tad Chamberlain Vol#: 19

C 458 Stephanie Schueler, P.E. Vol#: 19

C 459 Carolyn Long Vol#: 19

C 460 Marillyn George Vol#: 19

C 461 Mitchell Kalish Vol#: 19

C 462 Diana M. Burkley Vol#: 19

C 463 Linda Howe Vol#: 19

C 464 Denise Hall Vol#: 19

C 465 Sharon D. Krueger Vol#: 19

C 466 Michael S. Fenton Vol#: 19

C 467 Berniece Bear Vol#: 19

C 468 Voices for Animals Vol#: 19

C 469 Shawna Hurley Vol#: 20

C 470 Sarah Moran Vol#: 20

C 471 Country Roads Animal Sanctuary Vol#: 20

C 472 Elissa Ball Vol#: 20

C 473 Deva Joy Gouss, MSW, PC Vol#: 20

C 474 E. J. Sullivan Vol#: 20

C 475 Judy Libbey Vol#: 20

C 476 Jill Myers Vol#: 20

C 477 Kristina R. Cahill & Michael Wiesmeier Vol#: 20

C 478 Jan van Wyck Vol#: 20

C 479 Vicky Barbee Vol#: 20

C 480 Association of Food & Drug Officials Vol#: 20

C 481 Lu Haner Vol#: 20

C 482 Liz Knowles, Ed.D. Vol#: 20

C 483 Christine M. Brown Vol#: 20

C 484 Susan Kline Vol#: 20

C 485 Jackie Simonss Vol#: 20

C 486 Nancy Tucholski Vol#: 20

EC 4 Michael D. Rumsey Vol#: 18

LET 1 Clemson University Vol#: 18

98P-0683 Soy Protein Containing Products

C 142 National Food Processors Assn Vol#: 21

C 143 Cargill Oilseeds Processing Vol#: 21

99D-1454 Nasal spray, inhalation solution, suspension&spray drug prod

C 19 Generic Pharmaceutical Industry Assn Vol#: 1

99D-1738 Bioavilability & Bioequivalence Studies for Nasal Aerosols

C 7 IVAX Corporation Vol#: 1

C 8 Schering Corporation Vol#: 1

C 9 Clay-Park Labs, Inc Vol#: 1

C 10 Kos Pharmaceuticals, Inc Vol#: 1

99H-0480 Civil Money Penalties;Gary M Neugen,d/b/a Kernersville Amoco

CR 1 HFA-305 Vol#: 1

99H-2913 Civil Money Penalty;7-Eleven Inc,dba 7-Eleven #26292