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Dockets Entered On December 27, 2006
Table of Contents
Docket # Title
1978N-0065 Skin Bleaching Drug Products
2003N-0233 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients
2006D-0344 Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
2006D-0383 Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
2006N-0062 Expanded Access to Investigational Drugs for Treatment Use
2006N-0067 Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2006P-0415 Petition Seeking Regulation of Cloned Animals
2006P-0533 ANDA Suitability for Sterile Vancomycin Hydrochloride USP, 750 mg
2006P-0534 ANDA for Sterile Vancomycin Hydrochloride USP, 750 mg
1978N-0065 Skin Bleaching Drug Products
C 62
Attachment
Patton Boggs, LLP Vol #: 15
C 63 Gapardis Health and Beauty, Inc. d/b/a Mitchell Group USA Vol #: 15
C 64 Image Dermatology, P.C. Vol #: 15
C 65 E. Scott, MD Vol #: 15
C 66 American Health & Beauty Aids Institute (AHBAI) Vol #: 15
C 67 Mount Sinai School of Medicine Vol #: 15
C 68
Attachments
AGI Dermatics Vol #: 15
EC 528 Mrs. Christine Cleveland Vol #: 19
EC 529 Sandler, Travis and Rosenber, P.A. Vol #: 19
EC 530 Sandler, Travis and Rosenberg, P.A. Vol #: 19
EC 531 Mrs. Sandra Rojas Vol #: 19
EC 532 Ms. Maribeth Nelson Vol #: 19
EC 533 Dr. Shari Clarke Vol #: 19
EC 534 Mrs. kathleen Howells Vol #: 19
EC 535 Dr. Lubna Isho Vol #: 19
EC 536 Key Laser Institute Vol #: 19
EC 537 Ms. Sharyn Goebelt Vol #: 19
EC 538 Dr. Roland Beverly Vol #: 19
EC 539 Mrs. Barbara Perrin Vol #: 19
EC 540 Ms. Janet Christo Vol #: 19
EC 541 University of Barcelona,Sagrado Corazon, hospital Vol #: 19
SUP 1 T. Franz, MD Vol #: 15
2003N-0233 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients
SUP 4 BASF Aktiengesellschaft (BASF AG) Vol #: 9
2006D-0344 Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
C 13 In-Vitro technologies, Inc. Vol #: 1
2006D-0383 Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
EC 4330 Mrs. Dorothy Vining Vol #: 25
EC 4331 Mrs. Lori Howard Vol #: 25
EC 4332 Mrs. shirley jacksack Vol #: 25
EC 4333 Mrs. Lisa Schneider Vol #: 25
EC 4334 Ms. Pat Goltz Vol #: 25
EC 4335 Violet Pigeon Productions (International) Vol #: 25
EC 4336 Ms. Barbara Sirovatka R.N. Vol #: 25
EC 4337 St Luke Church - Sanctity of Life Committee Vol #: 25
EC 4338 Mrs. Lori Murphy Vol #: 25
EC 4339 Mrs. Mary Rhodes Vol #: 25
EC 4340 Mrs. ekaterina krotikova Vol #: 25
EC 4341 Dr. Tom Benton Vol #: 25
EC 4342 Mrs. Janet Storey Vol #: 25
EC 4343 Mrs. Maureen Andrzejewski Vol #: 25
EC 4344 Dr. Frederick Zivnuska Vol #: 25
EC 4345 Ms. Lucy Knouse Vol #: 25
EC 4346 Mrs. Judy Lane Vol #: 25
EC 4347 Mrs. Rachael Detwiller Vol #: 25
EC 4348 Mrs. Katie Donahue Vol #: 25
EC 4349 Miss. Elise Baker Vol #: 25
EC 4350 Mrs. Annie Jacobs Vol #: 25
EC 4351 Catholic Vol #: 25
EC 4352 Mr. Ron Kelsey Vol #: 25
EC 4353 Ms. Colleen Eickmeier Vol #: 25
EC 4354 Mrs. Cathy Lees Vol #: 25
EC 4355 Mrs. Christie Stabile Vol #: 25
EC 4356 Dr. J. Douglas Menietti Vol #: 25
EC 4357 Mrs. Helene Hale Vol #: 25
EC 4358 Mr. DONALD DE MARCO Vol #: 25
EC 4359 Mrs. Mary Lareau Vol #: 25
EC 4360 Mrs. MaryAnn Heywood Vol #: 25
EC 4361 Mr. Michael Fitzmaurice Vol #: 25
EC 4362 American Citizen Vol #: 25
EC 4363 Mrs. Dena Wiesner Vol #: 25
EC 4364 Mrs. Ariane Fisher Vol #: 25
EC 4365 Mrs. Amy Enright Vol #: 25
EC 4366 Mr. David Lucas Vol #: 25
EC 4367 Mrs. Laurinda Lucas Vol #: 25
EC 4368 Mrs. Laura Witteman Vol #: 25
EC 4369 Mr. Phil Seng Vol #: 25
EC 4370 Miss. Sharon Howey Vol #: 25
EC 4371 Mr. Patrick Schultz Vol #: 25
EC 4372 Mrs. Jean Ginsbach Vol #: 25
EC 4373 Mr. Cameron McLarty Vol #: 25
EC 4374 Mrs. Lani Bogart Vol #: 25
EC 4375 Mr. Dave Kolar Vol #: 25
EC 4376 Mr. Phillip Butterfield Vol #: 25
EC 4377 Mr. REV. LEE JIROVSKY Vol #: 25
EC 4378 Mrs. Cathy Bender Vol #: 25
EC 4379 Mrs. Vfirginia Almon Vol #: 25
EC 4380 Dr. Mary Knight Vol #: 25
EC 4381 Mrs. Charles Bixenmann Vol #: 25
EC 4382 Mrs. Elizabeth Shea Vol #: 25
EC 4383 Mr. J Dowling Vol #: 25
EC 4384 Mrs. Mary Bontjes Vol #: 25
EC 4385 Mrs. Davin (Janet) Lee Vol #: 25
EC 4386 Mrs. Jennifer Babin Vol #: 25
EC 4387 Mr. Aaron Seng Vol #: 25
EC 4388 Mrs. Shirley Dowling Vol #: 25
EC 4389 Dr. George Isajiw Vol #: 25
EC 4390 Mrs. Rene Schneider Vol #: 25
EC 4391 Mr. John Endredy Vol #: 25
EC 4392 Mrs. Jennifer Cargille Vol #: 25
EC 4393 Mrs. georgiane skid Vol #: 25
EC 4394 Mrs. Kimberly Bidleman Vol #: 25
EC 4395 Mr. Travis Yeager Vol #: 25
EC 4396 Miss. Virginia Klein Vol #: 25
EC 4397 Mrs. Barbara Copeland Vol #: 25
EC 4398 Nevada Care Medical Center Vol #: 25
EC 4399 Dr. Joyce Vogel Vol #: 25
EC 4400 Mrs. BETTY PAITZ Vol #: 25
EC 4401 Florida Catholic Conference Vol #: 25
EC 4402 Ms. Caroline Butkiewicz Vol #: 25
EC 4403 Mrs. kathleen hobein Vol #: 25
EC 4404 COUPLES FOR CHRIST Vol #: 25
EC 4405 Mrs. Joan Patton Vol #: 25
EC 4406 Mrs. Franci Nakamura Vol #: 25
EC 4407 Mrs. Amanda Conlan Vol #: 25
EC 4408 Mrs. Beth Van Natta Vol #: 25
EC 4409 Mr. Melvin Soboleski Vol #: 25
EC 4410 Mrs. Janet Weiss Vol #: 25
EC 4411 Mr. Scott Weberg Vol #: 25
EC 4412 Mrs. Kelly Zeichner Vol #: 25
EC 4413 Mrs. Margaret Schleeter Vol #: 25
EC 4414 Mrs. Angela Colgan Vol #: 25
EC 4415 Ms. Auri Lane Vol #: 25
EC 4416 Mrs. Diane Ruff Vol #: 25
EC 4417 Mrs. mertice gawne Vol #: 25
EC 4418 Mrs. lydia Wandler Vol #: 25
EC 4419 Registered Nurse Vol #: 25
EC 4420 Miss. Ann Marie McCabe Vol #: 25
EC 4421 Miss. Mary Lester Vol #: 25
EC 4422 Mr. roderick trafan Vol #: 25
EC 4423 Mr. John Hetland Vol #: 25
EC 4424 Mrs. Christina DeGance Vol #: 25
EC 4425 Mrs. Kari Curtin Vol #: 25
EC 4426 Mr. Terry Ducharme Vol #: 25
EC 4427 Mrs. Pat Jasko Vol #: 25
EC 4428 Dr. William Chavey Vol #: 25
EC 4429 Ms. Maureen Briskar Vol #: 25
EC 4430 Ms. MADELINE NEUMANN Vol #: 25
EC 4431 Ms. Mari Seraphim Vol #: 25
EC 4432 Mrs. Patricia Kelley Vol #: 25
EC 4433 Mr. Christopher Goodwin Vol #: 25
EC 4434 Mrs. Jeannette Nedza Vol #: 25
EC 4435 Mrs. Mary Klein Vol #: 25
EC 4436 Mrs. Nancy Mumphrey Vol #: 25
EC 4437 Mr. Nate Harburg Vol #: 25
EC 4438 Mr. Daniel Naegele Vol #: 25
EC 4439 Mrs. Catherine Carney Vol #: 25
EC 4440 Mr. Patrick Glatz Vol #: 25
EC 4441 Mrs. Margaret Stahr Vol #: 25
EC 4442 Mrs. Kimberly Byrne Vol #: 25
EC 4443 Ms. Lisa Cederoth Vol #: 25
EC 4444 Mrs. Dina Barron Vol #: 25
EC 4445 Mr. Rick Thelen Vol #: 25
EC 4446 Mr. john clegg Vol #: 25
EC 4447 Mr. Timothy Duff Vol #: 25
EC 4448 Mr. Nickolay Zenkov Vol #: 25
EC 4449 Mr. JAMES EVANS Vol #: 25
EC 4450 Miss. Mariann Werninck Vol #: 25
EC 4451 Mrs. Nancy Boll Vol #: 25
EC 4452 Mrs. Dorothy Tillberg Vol #: 25
EC 4453 Mrs. Jean M. Leapley Vol #: 25
EC 4454 Mrs. Karen Perry Vol #: 25
EC 4455 Embryos Alive Vol #: 25
EC 4456 Pauline Books Vol #: 25
EC 4457 Mrs. Margaret King Vol #: 25
EC 4458 Mrs. Sonia Tejeda Vol #: 25
EC 4459 Dr. Karen Spaccarelli Vol #: 25
EC 4460 Private Citizen Vol #: 25
EC 4461 Mrs. Paulette Hytinen Vol #: 25
EC 4462 Mr. James Keaney Vol #: 25
EC 4463 Ms. Angie Lipscomb Vol #: 25
EC 4464 Mrs. Theresa Falciano Vol #: 25
EC 4465 Miss. Sarah Downes Vol #: 25
EC 4466 Mr. jonadrian rice Vol #: 25
EC 4467 Mr. John Leslie Vol #: 25
EC 4468 Mr. Dominic Petan Vol #: 25
EC 4469 Kossuth County Right to Life Vol #: 25
EC 4470 Oblates of the Virgin Mary Vol #: 25
EC 4471 Lee County Right to Life Vol #: 25
EC 4472 Mr. JAMES COSGROVE Vol #: 25
EC 4473 Dr. Martha Cesena Vol #: 25
EC 4474 Mrs. Margaret Cochran Vol #: 25
EC 4475 St. Mary Magdalene Catholic Church Vol #: 25
EC 4476 St. Mary Magdalene Catholic Church Vol #: 25
EC 4477 Miss. Marissa Pfoff Vol #: 25
EC 4478 St. Mary Magdalene Catholic Chuch Vol #: 25
EC 4479 Mr. Lawrence RATCHFORD Vol #: 25
EC 4480 Mr. Tony Auciello Vol #: 25
EC 4481 Mr. Ben Garrity Vol #: 25
EC 4482 Mr. Andrew Nelson Vol #: 25
EC 4483 Mr. David Szostak Vol #: 25
EC 4484 St. Patrick Catholic Church Vol #: 25
EC 4485 Mr. Thomas Schuhler Vol #: 25
EC 4486 Rio Rancho Public Schools Vol #: 25
EC 4487 Mr. Richard Cernosek Vol #: 25
EC 4488 Miss. Anna Bosdachin Vol #: 25
EC 4489 Mrs. Diane Vincent Vol #: 25
EC 4490 Mrs. Gina Schiltz Vol #: 25
EC 4491 Mrs. Leila Lawler Vol #: 25
EC 4492 Miss. Elena Royal Vol #: 25
EC 4493 Mrs. Alice Cernosek Vol #: 25
EC 4494 Mrs. Barbara DeWolf Vol #: 25
EC 4495 Mrs. Kerry Costanzo Vol #: 25
EC 4496 Mrs. Patricia Peurrung Vol #: 25
EC 4497 Mrs. Christine La Fleur Vol #: 25
EC 4498 Mrs. margaret verni Vol #: 25
EC 4499 Dr. Jerome L'Ecuyer Vol #: 25
EC 4500 Mrs. Jeanne McMahon Vol #: 25
EC 4501 Mr. Bob Furey Vol #: 25
EC 4502 Mrs. Lisa Powell Vol #: 25
EC 4503 Mr. Thomas Kirner Vol #: 25
EC 4504 American College of Pediatricians Vol #: 25
EC 4505 none Vol #: 25
EC 4506 Mrs. Florence Bischof Vol #: 25
EC 4507 Mother of 4 under 6 Vol #: 25
EC 4508 Mrs. dana black Vol #: 25
EC 4509 Mr. Donald Schluender Vol #: 25
EC 4510 Ms. Denise Biersmith Vol #: 25
EC 4511 parish priest in Roman Catholic diocese Vol #: 25
EC 4512 Ms. Rita D'Souza Vol #: 25
EC 4513 St. Thomas Aquinas Respect Life Vol #: 25
EC 4514 Miss. Jill Thelen Vol #: 25
EC 4515 Mr. David Swyer Vol #: 25
EC 4516 Bonaventure Physical Therapy Vol #: 25
EC 4517 Mr. Andrew Flusche Vol #: 25
EC 4518 Miss. Lucia Whittaker Vol #: 25
EC 4519 Mrs. Joline Jackson Vol #: 25
EC 4520 Miss. Magdalena Whittaker Vol #: 25
EC 4521 Mr. Nicholas Jasko Vol #: 25
EC 4522 Mrs. Eileen Doherty Vol #: 25
EC 4523 Mrs. Whitney Hess Vol #: 25
EC 4524 Miss. Anna Whittaker Vol #: 25
EC 4525 Mr. Joshua Klein Vol #: 25
EC 4526 Ms. Irene Xenos Vol #: 25
EC 4527 Mr. James Berkery Vol #: 25
EC 4528 US Citizen Vol #: 25
EC 4529 Mrs. Deborah D'Andrea Vol #: 25
EC 4530 RN Vol #: 25
EC 4531 Mrs. Debbie Colon Vol #: 25
EC 4532 Mrs. terri gittings Vol #: 25
EC 4533 Mrs. Christy Lopez Vol #: 25
EC 4534 Dr. John Depner Vol #: 25
EC 4535 Mrs. Susan Plumb Vol #: 25
EC 4536 Mrs. Kim Racine Vol #: 25
EC 4537 J Hermann Vol #: 25
EC 4538 Mr. Jaksha T Tomic Vol #: 25
EC 4539 Mrs. Jennifer Tomic Vol #: 25
EC 4540 Mr. Adam Hoppe Vol #: 25
EC 4541 Ms. Katherine Pecha Vol #: 25
EC 4542 Dr. Stephen Reen Vol #: 25
EC 4543 Mrs. Heidi Papenhausen Vol #: 25
EC 4544 Mrs. Patricia Capps Vol #: 25
EC 4545 ARIZONA RIGHT TO LIFE TUCSON - SW CHAPTER Vol #: 25
EC 4546 Mrs. Elizabeth Kopec Vol #: 25
EC 4547 Mr. John Schreiner Vol #: 25
EC 4548 Mr. Vincent Zimmern Vol #: 25
EC 4549 Mrs. Suzanne Cote-Egusa Vol #: 25
EC 4550 Mrs. Lynn Gagnon Vol #: 25
EC 4551 Mr. Donald Conroy Vol #: 25
EC 4552 Dr. Thomas Gautsch Vol #: 25
EC 4553 Miss. Maureen O'Brien Vol #: 25
EC 4554 Mr. Vince and Mary Rigert Vol #: 25
EC 4555 Mrs. Anna Marie Walker Vol #: 25
EC 4556 Mrs. Pat Bruce Vol #: 25
EC 4557 Mrs. Dina Wool Vol #: 25
EC 4558 respect life catholic Vol #: 25
EC 4559 Mrs. Lisa Ciola Vol #: 25
EC 4560 Kirchhoff Institute, University of Heidelberg Vol #: 25
EC 4561 Mrs. Brigid Barker Vol #: 25
EC 4562 Mr. Paul Chapello Vol #: 25
EC 4563 Mr. Peter Klinkner Vol #: 25
EC 4564 Dr. D. G. Kennedy-Warley Vol #: 25
EC 4565 Mrs. Maureen Tygett RN Vol #: 25
EC 4566 Mr. Jeffery Tygett Vol #: 25
EC 4567 Mr. Dennis Finamore Vol #: 25
EC 4568 Mr. Sean Hoolehan Vol #: 25
EC 4569 Miss. Catherine Rooney Vol #: 25
EC 4570 Mr. Steve Lilly Vol #: 25
EC 4571 Mr. Russell Lacroix Vol #: 25
EC 4572 Mrs. Norma GIesman Vol #: 25
EC 4573 Mr. Richard Giesman Vol #: 25
EC 4574 Mrs. Karen Shields Vol #: 25
EC 4575 Mr. Dan Rooney Vol #: 25
EC 4576 Mrs. Katrina Halfpap Vol #: 25
EC 4577 Dr. GARY LEVY Vol #: 25
EC 4578 Dr. Margaret Hanlon Vol #: 25
EC 4579 Mrs. Heidi Morrow Vol #: 25
EC 4580 Mrs. Kathie Hempstead Vol #: 25
EC 4581 Mrs. Monserrate McMorris Vol #: 25
EC 4582 Mrs. Janine Perrault Vol #: 25
EC 4583 nurse practitioner Vol #: 25
EC 4584 Mrs. Colleen Perfect Vol #: 25
EC 4585 Mr. Donald Keefe, J.D.,S.T.D. Vol #: 25
EC 4586 Mr. Alton McGill Vol #: 25
EC 4587 Mrs. paulette gleason Vol #: 25
EC 4588 Ms. Margaret Closs Vol #: 25
EC 4589 Mr. Chris Ellis Vol #: 25
EC 4590 Mrs. Frances Carey Vol #: 25
EC 4591 Mrs. Sandra Wertz Vol #: 25
EC 4592 Mr. Anthony Moffett Vol #: 25
EC 4593 JSGroup Vol #: 25
EC 4594 Mr. Joseph Keenan Vol #: 25
EC 4595 Mrs. Marlene Mertes Vol #: 25
EC 4596 Mr. Bill Jones Vol #: 25
EC 4597 Affinity Medical Group Vol #: 25
EC 4598 Mrs. Margaret Avila Vol #: 25
EC 4599 NA Vol #: 25
EC 4600 Mrs. Julie Zackrisson Vol #: 25
EC 4601 Mrs. tessie lee Vol #: 25
EC 4602 Ms. Janet Baker Vol #: 25
EC 4603 childern of god for life Vol #: 25
EC 4604 Dr. Alyssa Pitstick Vol #: 25
EC 4605 Mrs. Mary Raple Vol #: 25
EC 4606 Mr. Gus Leano Vol #: 25
EC 4607 Orthopedics North East Vol #: 25
EC 4608 Mr. Steve Petullo Vol #: 25
EC 4609 Mr. alan a. glaser Vol #: 25
EC 4610 Mr. Victor Berlage Vol #: 25
EC 4611 Ms. E. Querubin Vol #: 25
EC 4612 Mr. Albert Vigland Vol #: 25
EC 4613 Registered Nurse Vol #: 25
EC 4614 Mrs. Patricia Enoch Vol #: 25
EC 4615 Mr. Robert Sweeney Vol #: 25
EC 4616 Ms. Helen Molnar Vol #: 25
EC 4617 Mr. Richard Ulrich Vol #: 25
EC 4618 Aerzte fuer das Leben e. V. Vol #: 25
EC 4619 Mr. Joseph Chronister Vol #: 25
EC 4620 Mr. Robert Barr Vol #: 25
EC 4621 Social Work Vol #: 25
EC 4622 Mr. harry mcaleavy Vol #: 25
EC 4623 Ms. Linda Chilcott Vol #: 25
EC 4624 Mrs. Anita Gill Vol #: 25
EC 4625 Ms. Cecilia Polt Vol #: 25
EC 4626 Mr. Andrew Chronister Vol #: 25
EC 4627 Ms. Jenny Binder Vol #: 25
EC 4628 Mrs. Barbara Kirk Vol #: 25
EC 4629 Mr. Patrick Burke Vol #: 25
EC 4630 Dr. Derek Moline Vol #: 25
EC 4631 Mrs. Lynn Luley Vol #: 25
EC 4632 Dr. Alvin Wong Vol #: 25
EC 4633 Mrs. Joanna Hitzelberger Vol #: 25
EC 4634 Mr. RW Ruff Vol #: 25
EC 4635 Mr. Michael Mitchell Vol #: 25
EC 4636 Ms. Christy McCollom Vol #: 25
EC 4637 Mr. Bennett Ellis Vol #: 25
EC 4638 Mrs. Elizabeth pukala Vol #: 25
EC 4639 Mrs. Diana Sheehy Vol #: 25
EC 4640 Dr. Clarence Sands Vol #: 25
EC 4641 Mrs. Cheryl Adams Vol #: 25
EC 4642 Mr. Paul Huseman Vol #: 25
EC 4643 Mrs. Gerri Garcia Vol #: 25
EC 4644 Mrs. Sarah Turner Vol #: 25
EC 4645 Mr. Keaton Lambert Vol #: 25
EC 4646 Mrs. Adrienne Burliuk Vol #: 25