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Dockets Management
Dockets Entered On February 23, 2005
Table of Contents
Docket # Title
1975N-0183H Health-Care Antiseptic Drug Products for OTC Human Use
1976N-0052N OTC Nasal Decongestants
1977N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products
1978N-0064 OTC Antiperspirant
1980N-0208 Biological Products; Bacterial Vaccines and Toxiods
1993V-0303 Laser Light Show
1995S-0316 75-Day Premarket Notifications for New Dietary Ingredients
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
2000N-0504 Egg Safety Action Plan
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2003D-0466 International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Studies to Evaluate the Safety of Resid
2004D-0377 International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
2004N-0454 Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
2004P-0315 Switch Pseudoephedrine from Over the Counter (OTC) Sales
2005N-0016 Agency Information Collection Activities; Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs: Study 1
2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing
2005P-0084 Commercial Brachytherapy Kits for Treatment of Prostate Cancer ; Non-Absorbable Bone Wax ; Non-Absorbable Reformulated "Faux Bone Wax" Needle Plugs
1975N-0183H Health-Care Antiseptic Drug Products for OTC Human Use
LET 44 HFD-1 to Hy-Gene Biomedical Corporation Vol #: 200
1976N-0052N OTC Nasal Decongestants
LET 122 HFD-560 to Bayer Corporation-Consumer Care Division Vol #: 77
1977N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products
C 243 Bayer HealthCare, LLC Vol #: 257
1978N-0064 OTC Antiperspirant
PAV 2 HFC-1 to The Cosmetic, Toiletry and Fragrance Association Vol #: 53
1980N-0208 Biological Products; Bacterial Vaccines and Toxiods
C 7 D. Johnson Vol #: 142
EREG 25 Matchette, Joseph Vol #: 140
1993V-0303 Laser Light Show
VRA 2 HFZ-300 to Lazer Vaudville Vol #: 1
1995S-0316
75-Day Premarket Notifications for New Dietary Ingredients
RPT 262 Loders Croklaan B V Vol #: 191
RPT 263 Nutrition 21 Vol #: 192
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 15540 AdvoCare International, L.P. Vol #: 137
LET 15541 AdvoCare International, L.P. Vol #: 137
LET 15542 AdvoCare International, L.P. Vol #: 137
LET 15543 Source Naturals Vol #: 137
LET 15544 Source Naturals Vol #: 137
LET 15545 Highland Laboratories Vol #: 137
LET 15546 Imagenetix, Inc. Vol #: 137
LET 15547 North American Pharmacal, Inc. Vol #: 137
LET 15548 Efamol Ltd. Vol #: 137
LET 15549 Hillestad Pharmaceuticals Vol #: 137
LET 15550 Hillestad Pharmaceuticals Vol #: 137
LET 15551 Source Naturals Vol #: 137
LET 15552 Hillestad Pharmaceuticals Vol #: 137
LET 15553 Hilestad Pharmaceuticals Vol #: 137
LET 15554 Hillestad Pharmaceuticals Vol #: 137
LET 15555 Oregon's Wild Harvest Vol #: 137
LET 15556 Inverness Medical, Inc. Vol #: 137
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
C 7473 H. Bitan Vol #: 319
2000N-0504 Egg Safety Action Plan
C 379 Humane Education Network Vol #: 32
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
C 2055 TheNordCenter Vol #: 300
2003D-0466 International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Studies to Evaluate the Safety of Resid
EC 2 LA Vol #: 1
2004D-0377 International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
EC 8 Monebo Technologies, Inc Vol #: 1
EC 9 Novartis Pharmaceuticals Biostatistics Vol #: 1
2004N-0454 Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
EC 371 HerbalAdvantage Vol #: 31
EC 372 Mr. Frank Di Mora Vol #: 31
EC 373 Mrs. Dolly Epstein Vol #: 31
EC 374 Mrs. JoAnn Burton Vol #: 31
EC 375 Mrs. Melissa Konrad Vol #: 31
EC 376 Ms. Susan Carey-Powell Vol #: 31
EC 377 Mrs. Susan Plahitko Vol #: 31
EC 378 Mrs. Susan Plahitko Vol #: 31
EC 379 Ms. Anne Lund Vol #: 31
EC 380 Mrs. Judith Van Caster Vol #: 31
EC 381 Mrs. Denise Christy Vol #: 31
EC 382 Mr. James McCombs Vol #: 31
EC 383 Mrs. Cynthia Arseneau Vol #: 31
EC 384 Ms. Julie Stack Vol #: 31
EC 385 Mr. Frank Lack Vol #: 31
EC 386 Mrs. Beverly Jacobson Vol #: 31
EC 387 Mrs. Deborah Farnham Vol #: 31
EC 388 Ms. Lanette Steadman Vol #: 31
EC 389 Mrs. lisa branik Vol #: 31
EC 390 Mrs. karen losego Vol #: 31
EC 391 Ms. Devonlee Byrd Vol #: 31
EC 392 build better health Vol #: 31
EC 393 build better health Vol #: 31
EC 394 Mr. Randal Watkins Vol #: 31
EC 395 Health Freedom Coalition Vol #: 31
EC 396 Ms. Kimberly Sharples Vol #: 31
EC 397 Mrs. Teri Hayes Vol #: 31
EC 398 Dr. Jean Hofve Vol #: 31
EC 399 Mrs. Bunnie Schunck Vol #: 31
EC 400 Mrs. Cynthia Graham Vol #: 31
EC 401 Mr. Willliam Kilgore Vol #: 31
EC 402 Mrs. Gwen Box Vol #: 31
EC 403 Mrs. Kratai Albert Vol #: 31
EC 404 Cindy Klement, NCN, ID, CH Vol #: 31
EC 405 Ms. Keli Ackroyd Vol #: 31
EC 406 Usana Health Sciences Vol #: 31
EC 407 Ms. Betty Allen Vol #: 31
EC 408 Nature's Sunshine Vol #: 31
EC 409 Member Nature's Sunshine Products Vol #: 31
EC 410 Mrs. Susan Boothe Vol #: 31
EC 411 Mr. Peter Schmolze Vol #: 31
EC 412 Ms. Carolyn Badalamente Vol #: 31
EC 413 Mrs. Maria Beardsley Vol #: 31
EC 414 Mrs. Barbara Flanders Vol #: 31
EC 415 Mrs. Pam Davis Vol #: 31
EC 416 Miss. Chris Anderson Vol #: 31
EC 417 Ms. Barbara Warrington Vol #: 31
EC 418 Ms. Carolyn Sullivan Vol #: 31
EC 419 Dr. John Monagin Vol #: 31
EC 420 Look-out Mountain Youth Facility Vol #: 31
EC 421 Ms. Janice Monagin Vol #: 31
EC 422 Self Vol #: 31
EC 423 Mr. Robert Warren Vol #: 31
EC 424 Mr. David Filkins Vol #: 31
EC 425 Mrs. Michele Barry Vol #: 31
EC 426 Ms. Joyce St. John Vol #: 31
EC 427 Mr. Winn Box Vol #: 31
EC 428 Mrs. ginger craigo Vol #: 31
EC 429 Mrs. Brenda Chambers Vol #: 31
EC 430 Ms. Stacie Bables Vol #: 31
EC 431 Mrs. JulieAnn Moon Vol #: 31
EC 432 Friends 4 Life Co-op, Inc. Vol #: 31
EC 433 Mrs. Sandra Nesky Vol #: 31
EC 434 Mrs. Ellen Benavidez Vol #: 31
EC 435 Mrs. Shonte Carter Vol #: 31
EC 436 INDENA S.p.A. Vol #: 31
EC 437 Ms. Julia Thornbrough Vol #: 31
EC 438 American Medical Association Vol #: 31
EC 439 None Vol #: 31
EC 440 Mr. Philip Goin Vol #: 31
EC 441 Mr. Jerry Carlberg Vol #: 31
EC 442 Ms. Claire Hostettler Vol #: 31
EC 443 Mrs. Yvonne Kilpatrick Vol #: 31
EC 444 Ms. Cecilia Smith Vol #: 31
EC 445 Ms. Dorothy Scott Vol #: 31
EC 446 Mrs. Paula Ruddick Vol #: 31
EC 447 Mrs. Vicky Lynn Olsen Vol #: 31
EC 448 Mr. Kenneth Olsen Vol #: 31
EC 449 Mr. barry winchell Vol #: 31
EC 450 Mr. Randy Ruddick Vol #: 31
EC 451 Sanctuary of the Beloved Vol #: 31
EC 452 Mrs. Jan Jones Vol #: 31
EC 453 Health and Nutrition Center Vol #: 31
EC 454 Mrs. Rita Bohn Vol #: 31
EC 455 Balanced Life Unlimited Vol #: 31
EC 456 USA Next/United Seniors Association Vol #: 31
EC 457 USA Next/United Seniors Association Vol #: 31
EC 458 USA Next/United Seniors Association Vol #: 31
EC 459 USA Next/United Seniors Association Vol #: 31
EC 460 USA Next/United Seniors Association Vol #: 31
EC 461 Mrs. kathy rowe Vol #: 31
EC 462 Dr. Thuan Tran Vol #: 31
EC 463 Ms. radha gaines Vol #: 31
EC 464 My health Vol #: 31
EC 465 Personal Evolutionary Tutoring Vol #: 31
EC 466 Educated Consumer Vol #: 31
EC 467 Mr. Paul Tsui Vol #: 31
EC 468 Ms. Glinda Watts Vol #: 31
EC 469 Ms. Candace Hoke Vol #: 31
EC 470 Mrs. Sheila Lugaresi Vol #: 31
EC 471 Mrs. Kathy Greenlee Vol #: 31
EC 472 Mrs. Heather Clarke Vol #: 31
EC 473 Ms. Maree Stone Vol #: 31
EC 474 Ms. Eliane Coleman Niemann Vol #: 31
EC 475 Ms. Ruth Cardall Vol #: 31
EC 476 Ms. Connie Cowles-Biederbeck Vol #: 31
EC 477 Ms. Lynn K Stevens Vol #: 31
EC 478 Ms. Deb Ruica Vol #: 31
EC 479 Mrs. Laura McGinty Vol #: 31
EC 480 Ms. Carol M Jenson Vol #: 31
EC 481 Ms. Christine Harder Vol #: 31
EC 482 Ms. Connie Bennett Vol #: 31
EC 483 Ms. Cindy L Light Vol #: 31
EC 484 Mr. Jack Moore Vol #: 31
EC 485 Ms. Marilyn Villaro Vol #: 31
EC 486 Ms. Jeanne H. Morris Vol #: 31
EC 487 Ms. Katherine D. Banks Vol #: 31
EC 488 Ms. Cindy Kearney Vol #: 31
EC 489 Ms. Jordon Orleans Vol #: 31
EC 490 Ms. Ruth Humble Vol #: 31
EC 491 Ms. Cheryl Keough Vol #: 31
EC 492 Mrs. Tina Moore Vol #: 31
EC 493 Miss. Kimberly Matteo Vol #: 31
EC 494 Ms. Bethany Payne Vol #: 31
EC 495 Mr. James Conahan Vol #: 31
EC 496 Mrs. Molly Conahan Vol #: 31
EC 497 Mr. Marcus Catlett Vol #: 31
EC 498 Ms. Martha Stork Vol #: 31
EC 499 Ms. Christina Stephens Vol #: 31
EC 500 Ms. Cynthia Wagner Vol #: 31
EC 501 Ms. Sharolyn Henry Vol #: 31
EC 502 Ms. Pat M. James Vol #: 31
EC 503 Mr. Greg Ethridge Vol #: 31
EC 504 Mrs. Gloria Ethridge Vol #: 31
EC 505 Ms. Shawna Barnes Vol #: 31
EC 506 Ms. Mary Lynn Sadowski Vol #: 31
EC 507 Ms. Rochelle C. Leiser Vol #: 31
EC 508 Mr. Alfredo Hadera Vol #: 31
EC 509 Ms. Ayde Gonzales Vol #: 31
EC 510 Ms. Cecile L'Angelle Vol #: 31
EC 511 Ms. Linda Dawson Vol #: 31
EC 512 Ms. Stephanie Beder Vol #: 31
EC 513 Ms. Crystal Beder Vol #: 31
EC 514 Ms. Mary Waterman Vol #: 31
EC 515 Ms. Terry Yurky Vol #: 31
EC 516 Ms. Cecelia Puliafico Vol #: 31
EC 517 Mr. Jim Puliafico Vol #: 31
EC 518 Ms. Nicole Milan Vol #: 31
EC 519 Ms. Carol Milan Vol #: 31
EC 520 Ms. Gwynne Larsen Vol #: 31
EC 521 Ms. Beth Ryan Vol #: 31
EC 522 Ms. Karen Patterson Vol #: 31
EC 523 Ms. Audress Johnson Vol #: 31
EC 524 Mr. TroyAnn Krebs Vol #: 31
EC 525 Ms. Diane Doukas Vol #: 31
EC 526 Ms. Diane Doukas Vol #: 31
EC 527 Ms. Kim Gallup Vol #: 31
EC 528 Ms. Maureen Mone Vol #: 31
EC 529 Mr. Bruce Hinchley Vol #: 31
EC 530 Mrs. Melissa Backer Hinchley Vol #: 31
EC 531 Ms. Lonnie Rejda Vol #: 31
EC 532 Ms. Michelle Arroyo-Paeplow Vol #: 31
EC 533 Mr. Christopher Mazzeo Vol #: 31
EC 534 Ms. Cynthia Crowther Vol #: 31
EC 535 Mr. David Wong Vol #: 31
EC 536 Mr. Kent Griswold Vol #: 31
EC 537 Mrs. Ellen Griswold Vol #: 31
EC 538 Miss. Hope Griswold Vol #: 31
EC 539 Mustard Seed Herbary Vol #: 31
EC 540 Mustard Seed Herbery Vol #: 31
EC 541 Ms. Gayle Danner Vol #: 31
EC 542 Mrs. Jennifer Crippen Vol #: 31
EC 543 Ms. Debra Masters Vol #: 31
EC 544 Miss. Roslyn Christy Vol #: 31
EC 545 Ms. Linda Wheelock Vol #: 31
EC 546 Mr. Martin Leaventon Vol #: 31
EC 547 Ms. Martha Lott Raby Vol #: 31
EC 548 Mrs. Bonnie Matheson Vol #: 31
EC 549 Ms. Kathy Smith Vol #: 31
EC 550 Ms. Kendra Gaines Vol #: 31
EC 551 Ms. V. Elizabeth` WELLS Vol #: 31
EC 552 Mrs. April Clark Vol #: 31
EC 553 Dr. Kathryn Hoster Vol #: 31
EC 554 Council for Responsible Nutrition Vol #: 31
EC 555 Mrs. Halina Hladysz Vol #: 31
EC 556 Individual Vol #: 31
EC 557 Ms. Claudia McNeely Vol #: 31
EC 558 Tree of Life Rejuvenation Center Vol #: 31
EC 559 National Nutritional Foods Association Vol #: 31
EC 560 Dr. Katherine DeVore Vol #: 31
EC 561 Ms. Diana Stevens Vol #: 31
EC 562 Mrs. Cynthia Russell Vol #: 31
EC 563 Mrs. Susan Miller Vol #: 31
EC 564 Ms. C Sonego Vol #: 31
EC 565 NSP Vol #: 31
EC 566 Ms. JANY SABINS Vol #: 31
EC 567 Consumer Healthcare Products Association Vol #: 31
EC 568 Mrs. Anna Thoeng Vol #: 31
EC 569 Consumer Healthcare Products Association Vol #: 31
EC 570 Mrs. Jimmie Nell Walker Vol #: 31
EC 571 CHPA Vol #: 31
EC 572 Pharmavite LLC Vol #: 31
EC 573 Mr. Ernest Walker Vol #: 31
EC 574 Mrs. Sylvia Thoeng Vol #: 31
EC 575 Mrs. Kimberly Parish Vol #: 31
EC 576 Mr. Steve Mauch Vol #: 31
EC 577 American Botanical Council Vol #: 31
EC 578 Mrs. MADELINE HOUDEK Vol #: 31
EC 579 Patton Boggs LLP Vol #: 31
EC 580 Mrs. Karen Dickey Vol #: 31
EC 581 Ms. Sharron Keeter Vol #: 31
EC 582 Mrs. Catherine Fish Vol #: 31
EC 583 Complementary Therapy Comm ALVMA Vol #: 31
EC 584 Mrs. Suzanne Gossett Vol #: 31
EC 585 Ms. Deborah Rogers Vol #: 31
EC 586 Mrs. Lorinda Briesacher Vol #: 31
EC 587 Ms. Debra Walker Vol #: 31
EC 588 Ms. Nora Hardy Vol #: 31
EC 589 Sports and Diet Supplement Industry Supporter Vol #: 31
EC 590 Ms. Angelika Szot Vol #: 31
EC 591 Mr. maurice mcbean Vol #: 31
EC 592 Mrs. Kimberly Armstrong Vol #: 31
EC 593 Mrs. Carol Milhous Vol #: 31
EC 594 Mrs. Pamela Pinto Vol #: 31
EC 595 Mr. Raymond Long Vol #: 31
EC 596 Mr. campbell scott Vol #: 31
EC 597 Mr. John Perkins Vol #: 31
2004P-0315 Switch Pseudoephedrine from Over the Counter (OTC) Sales
LET 1 HFD-1 to Pharmacists Planning Services Inc (PPSI) Vol #: 1
2005N-0016 Agency Information Collection Activities; Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs: Study 1
BKG 1 Draft Interview Protocol Vol #: 1
2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing
APE 3 Citizens for Responsible Care and Research (CIRCARE) Vol #: 1
EAPE 96 Susko, Michael Vol #: 1
EAPE 97 Susko, Michael Vol #: 1
EAPE 98 Susko, Michael Vol #: 1
EAPE 99 Susko, Michael Vol #: 1
EAPE 100 Susko, Michael Vol #: 1
EAPE 101 Donoho, Carol Vol #: 1
EAPE 102 Alfano, Sandra Vol #: 1
EAPE 103 Collier, Elaine Vol #: 1
EAPE 104 Jenkins-Showalter, Janet Vol #: 1
EAPE 105 Jenkins-Showalter, Janet Vol #: 1
EAPE 106 Nicholson, Anna Vol #: 1
EAPE 107 Dixon, Dennis O Vol #: 1
EC 4 Saint Luke's Hospital of Kansas City IRB Vol #: 1
2005P-0084 Commercial Brachytherapy Kits for Treatment of Prostate Cancer ; Non-Absorbable Bone Wax ; Non-Absorbable Reformulated "Faux Bone Wax" Needle Plugs
ACK 1 HFA-305 to World Wide Medical Technologies Vol #: 1
CP 1 World Wide Medical Technologies Vol #: 1

Page created on February 24, 2005 kk
Page updated on March 30, 2005 rc

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