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 August 20, 2001 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 yourcorrespondence. |
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77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products
SUP 45 McNeil Consumer Healthcare Vol#: 235
78N-036L OTC Laxative
LET 192 Perrigo Company Vol#: 107
97P-0102 Drug acetaminophen tend to deplete glutathione for HIV-infec
LET 1 HFD-1 to Dept of Genetics, Stanford Univ Vol#: 1
98P-0203 Eliminate Forced Molting of Laying Birds
C 1958 Judy Alessio Vol#: 47
99D-2213 Invalidation of test results when using licensed & 510(k)
EMC 1 Pat Fleury Vol#: 1
EMC 2 Haley McCrary Vol#: 1
00D-1033 Clinical Trials for Serious/Life-Threatening Diseases
C 5 Kidney Cancer Association Vol#: 1
00D-1598 Voluntary Labeling for Bioengineered Foods
C 7522 Jeff Miller Vol#: 429
C 7523 Joyce Tassinare Vol#: 429
C 7524 Dr. Colleen Trambley Vol#: 429
C 7525 Rene Philippe Vol#: 429
C 7526 Kallie Keith Vol#: 429
C 7527 Maureen E. Cole Vol#: 429
EMC 11723 Michelle Doane Vol#: 426
00N-0074 Safeguards for Children Clinical Ivestigations FDA-Regulated
C 15 National Human Research Protections AC Vol#: 1
EMC 1 Alicia Stephens Vol#: 2
EMC 2 Alliance for Human Research Protection Vol#: 2
00N-1396 Bioengineered Foods Consumed By Humans or Animals
C 8539 Jenny Walker Vol#: 289
C 8540 Irene Smith Vol#: 289
C 8541 Elisabeth Howard Vol#: 289
C 8542 Deb McNamara Vol#: 289
C 8543 Robert McNamara Vol#: 289
C 8544 M.Glombaski Vol#: 289
C 8545 Kelly Evans Vol#: 289
C 8546 Daniel A. Henning,Ph.D. Vol#: 289
C 8547 W.W. Drawbough Vol#: 289
C 8548 Susan Emge Milliner Vol#: 289
C 8549 Ginette Roth Vol#: 289
C 8550 Laura L. Basl Vol#: 289
C 8551 Julie Ann Smith Vol#: 289
C 8552 Kathleen E. Coyner Vol#: 289
C 8553 Gloria Motsinger Vol#: 289
C 8554 no signature Vol#: 289
C 8555 E. Cramp Vol#: 289
C 8556 Wanda Harvey-Lewis Vol#: 289
C 8557 Mr. Randall Man Vol#: 289
C 8558 Ms. Rachel Thompson Vol#: 289
C 8559 Jean Guthrie Vol#: 289
C 8560 Kenia Guardado Vol#: 289
C 8561 M. R. Rowley Vol#: 289
C 8562 John McClellan Vol#: 289
C 8563 Elizabeth Gerstley Vol#: 289
C 8564 Ric Sudborough Vol#: 289
C 8565 Jessica Fielden Vol#: 289
C 8566 Albert & Nellie Brakespear Vol#: 289
C 8567 Laureen Swindler Vol#: 289
C 8568 R. F. Mills Vol#: 289
C 8569 Brenda Hudgins Vol#: 289
C 8570 L. Eleanor Finney Vol#: 289
C 8571 Mary S. Woodcock Vol#: 289
C 8572 Gloria Estrada Vol#: 289
C 8573 Maris Arnold Vol#: 289
C 8574 Patricia Ross Vol#: 289
C 8575 Karolyn Berkman Vol#: 289
C 8576 Martha Shaw Vol#: 289
C 8577 Joan and Cecil Dossett Vol#: 289
C 8578 B. A. Miller Vol#: 289
C 8579 Gerry Mutuski Vol#: 290
C 8580 Dawn Mutuski Vol#: 290
C 8581 unreadable Vol#: 290
C 8582 unreadable Vol#: 290
C 8583 Mathilde Oppenheim Vol#: 290
C 8584 Karen B. Dantinne Vol#: 290
C 8585 Mrs. Margaret D. Carter Vol#: 290
C 8586 Aurora D. Rugh Vol#: 290
C 8587 June Adams Vol#: 290
C 8588 Barbara Soille Vol#: 290
C 8589 Jennifer Garcia Vol#: 290
C 8590 Marjorie E. Kaine Vol#: 290
C 8591 G. Muhammad Vol#: 290
C 8592 Erin Hillier Vol#: 290
C 8593 Eva M. Ciabattoni Vol#: 290
C 8594 Rachelle Bell Vol#: 290
C 8595 Lefty & Nancy Dawn Martin Vol#: 290
C 8596 Dorothy Geisler Vol#: 290
C 8597 Paula Cohn Vol#: 290
C 8598 John Burke Vol#: 290
C 8599 Carmen K. Mcelwee Vol#: 290
C 8600 Ann M. Russell Vol#: 290
C 8601 Ingelore & Ernest Weinberg Vol#: 290
C 8602 Helen Campbell Vol#: 290
C 8603 Helen Blanding Vol#: 290
C 8604 Tally Mezzanatto Vol#: 290
C 8605 Mary Goodwin Vol#: 290
C 8606 Doris Grinn Vol#: 290
C 8607 Douglass Perske Vol#: 290
C 8608 Teresa Dixon Vol#: 290
C 8609 Gretchen Glad & Bert Taylor Vol#: 290
C 8610 Colleen Whalen Vol#: 290
C 8611 S. J. Hork Vol#: 290
C 8612 Virginia Sweet Vol#: 290
C 8613 Michael Lamperd Vol#: 290
C 8614 unreadable Vol#: 290
C 8615 Christina Crumpton Vol#: 290
C 8616 Bill Riesenberger Vol#: 290
C 8617 M. L. Rennick Vol#: 290
C 8618 Nancy Luffy Vol#: 290
C 8619 Mrs. Jennifer Vance Vol#: 290
C 8620 Michele R. Braley Vol#: 290
C 8621 Mae S. Harms Vol#: 290
C 8622 Mark Feblowitz Vol#: 290
C 8623 Sophie Fleming Vol#: 290
C 8624 Rena Mayyar Vol#: 290
C 8625 Reba Johnson Vol#: 290
C 8626 Ms. Jean Ito Vol#: 290
C 8627 unreadable Vol#: 290
C 8628 Raymond B. & Mary Jane Hoff Vol#: 290
C 8629 Thomas Browne Vol#: 290
C 8630 Judith Bell & Daniel E. Ellenburg,Ph.D. Vol#: 290
C 8631 Suzi Neu Vol#: 290
C 8632 Jeannette Muzima Vol#: 290
C 8633 Klara M. Droessler Vol#: 290
C 8634 Marilyn Garrett Vol#: 290
C 8635 June Maselbas Vol#: 290
C 8636 Ray H. Katz Vol#: 290
C 8637 Judy B. Low Vol#: 290
C 8638 Sharon M. Kilgore Vol#: 290
C 8639 H. W. Ruhm Vol#: 290
C 8640 Teresa Dunn Vol#: 290
C 8641 Nancy Nitsch Vol#: 290
C 8642 Julie Vandenwal Vol#: 290
C 8643 Jaon Jordan Vol#: 290
C 8644 Janet Crain Vol#: 290
C 8645 Wendy Milici Vol#: 290
C 8646 Victoria L. States Vol#: 290
C 8647 Donna Cotner Vol#: 290
C 8648 Ilona I Marshall Vol#: 290
C 8649 Tracey Martin Vol#: 290
C 8650 S. Jeffrey Vol#: 290
C 8651 Bob Busby & Maureen Coute Vol#: 290
C 8652 Ilyse Simon Vol#: 290
C 8653 Michael Spivak Vol#: 290
C 8654 Dianne Mahler Vol#: 290
C 8655 A. Ann Pulley Vol#: 290
C 8656 Carol Deangelis Vol#: 290
C 8657 Connie Sing Vol#: 290
C 8658 Bonnie E. Kendrick Vol#: 290
C 8659 Kristina Turner Vol#: 290
C 8660 John B. Gallagher Vol#: 290
C 8661 Judy Owsowitz Vol#: 290
C 8662 Charlotte Stark Vol#: 290
C 8663 Marion E. Wadsworth Vol#: 290
C 8664 Jan Brandenburg Vol#: 290
C 8665 Jean and Kenneth Wentworth Vol#: 290
C 8666 Mary Jane Daughenbaugh Vol#: 290
C 8667 Stacey London Vol#: 290
C 8668 Larry Sugisaki Vol#: 290
C 8669 Lisha Doucet Vol#: 290
C 8670 Brittany Ridley Vol#: 290
C 8671 Sofia Zander Vol#: 290
C 8672 Mrs. D. L. DeMott Vol#: 290
C 8673 Kathleen M. Searl Vol#: 290
C 8674 David Anderson Vol#: 290
C 8675 Dona Meyer Vol#: 290
C 8676 Mrs. Mildred M. Paris Vol#: 290
C 8677 Bonnie J. Greeley Vol#: 290
C 8678 Jay Finneburgh Vol#: 290
C 8679 Linda Sherman Vol#: 290
C 8680 Emily Marchione Vol#: 290
C 8681 Donald Nofziger Vol#: 290
C 8682 Susanna Waiche Vol#: 290
C 8683 Dean and Fran Stegmann Vol#: 290
C 8684 Jennifer Ryan Vol#: 290
C 8685 Ms. Kathleen Wakamatsu Vol#: 290
C 8686 Alicia Vere Vol#: 290
C 8687 Caroline Seckinger Vol#: 290
C 8688 Lisa and Chris Guttormsson Vol#: 290
C 8689 Thomas Family Vol#: 290
C 8690 Jean S. Pitches and Leo L. Keene Vol#: 290
C 8691 Brooke Adbelnoor Vol#: 290
C 8692 B. R. Guillory Vol#: 290
C 8693 Pandora Punter Mitchell Vol#: 290
C 8694 Rachel Chaput Vol#: 290
C 8695 Marty L. R. Kovacs Vol#: 290
C 8696 Paul A. Janowitz Vol#: 290
C 8697 Linda McCall Vol#: 290
C 8698 no signature Vol#: 290
C 8699 Andrea Kiefe Vol#: 290
C 8700 Peter Kavanaugh Vol#: 290
C 8701 Misha Rauchwezer Vol#: 290
C 8702 Page Designs Inc. Vol#: 290
C 8703 James Robinson Vol#: 290
C 8704 Mrs. Ruth Burch Vol#: 290
C 8705 Gaetano Vol#: 290
C 8706 Julie Matthaei Vol#: 290
C 8707 Cindy Haidu-Banks Vol#: 290
C 8708 Rita Robison Vol#: 290
C 8709 Barbara DeGregoria, Ph.D. Vol#: 290
C 8710 Amelia Hennighausen Vol#: 290
C 8711 Kelly Lubeck Vol#: 291
C 8712 Jim Swoish Vol#: 291
C 8713 Patricia M. Spence Vol#: 291
C 8714 Christina L. Bosch Vol#: 291
C 8715 Charles A. Joseph Vol#: 291
C 8716 M. G. Allison Vol#: 291
C 8717 David McMuller Vol#: 291
C 8718 Ms. Brenda L. Caldwell Vol#: 291
C 8719 Renee A. Nastri-Windisch Vol#: 291
C 8720 Rudy Kelly Vol#: 291
C 8721 Laurie Fine Vol#: 291
C 8722 unreadable Vol#: 291
C 8723 T. Scali Vol#: 291
C 8724 unreadable Vol#: 291
C 8725 Gael Dusken Vol#: 291
C 8726 Eva A. Macki Vol#: 291
C 8727 Sister Ruth Eggering Vol#: 291
C 8728 Catherine Williams Vol#: 291
C 8729 Kelly Green Vol#: 291
C 8730 Alice Ordway Vol#: 291
C 8731 Sue and Tom Miller Vol#: 291
C 8732 Arlene Montgomery Vol#: 291
C 8733 K. Rice Vol#: 291
C 8734 Meyer Scharlack Vol#: 291
C 8735 Brian Schmitt Vol#: 291
C 8736 Sara Michelle Johnston Vol#: 291
C 8737 Laurie Schultz Vol#: 291
C 8738 Marion Sweeney Vol#: 291
C 8739 Gael Dusken Vol#: 291
C 8740 no signature Vol#: 291
C 8741 Eyleen Hawkins Vol#: 291
C 8742 Sarah Goldbaum Vol#: 291
C 8743 Doris Lloyd Vol#: 291
C 8744 Roberta Rigsby Vol#: 291
C 8745 Ted Rowen Vol#: 291
C 8746 L. Schwartzman Vol#: 291
C 8747 Pat Dennstedt Vol#: 291
C 8748 Annie Wyndham Vol#: 291
C 8749 Charles Jamieson Vol#: 291
C 8750 Virginia Hammer Vol#: 291
C 8751 Carol Cochella Vol#: 291
C 8752 Noelle Ostrom Vol#: 291
C 8753 Cheryl McEntire Vol#: 291
C 8754 Grace Sanders-Doons Vol#: 291
C 8755 Grace Sanders-Doons Vol#: 291
C 8756 Greer Stangl Vol#: 291
C 8757 Mary Ostrander Vol#: 291
C 8758 Mike Talker Vol#: 291
C 8759 Maria Sanfoval Vol#: 291
C 8760 Kate Molling Vol#: 291
C 8761 Kevin Trammel Vol#: 291
C 8762 F. C. English Vol#: 291
C 8763 Dodi Ehlert Vol#: 291
C 8764 Mary Mosenfelder Vol#: 291
C 8765 Virginia Bennett Vol#: 291
C 8766 Diane Sultan Vol#: 291
C 8767 Mary Chandra Vol#: 291
C 8768 Marshall Ocker Vol#: 291
C 8769 Lauren Swindler Vol#: 291
C 8770 Geneva Agnes Gates Vol#: 291
C 8771 Marie Koerner Vol#: 291
C 8772 David Cutler Vol#: 291
C 8773 Ms. Georgia D. Harbin Vol#: 291
C 8774 M. Ries Vol#: 291
C 8775 Michael Savino Vol#: 291
C 8776 Lee Preble Vol#: 291
C 8777 Carol Waide Vol#: 291
C 8778 Gervase Raphael Vol#: 291
C 8779 Shauna Haines Vol#: 291
C 8780 Julia Cato Vol#: 291
C 8781 Patricia M. Ballard Vol#: 291
C 8782 Y. Stumer Vol#: 291
C 8783 Shelley Hight Vol#: 291
C 8784 Richard H. MacCarsey, Jr. Vol#: 291
01D-0193 Premarket Notifications for Biological Indicators Intended
C 7 Nathan L Belkin PhD Vol#: 1
C 8 Advanced Steriliation Products Vol#: 1
01D-0297 Avail. of Info Given to Advisory Committee Members CDRH
01N-0308 Agency Information Collection; Financial Disclosure
EMC 1 Nancy Ferzola Vol#: 1
01P-0230 Domestic Marketing & Importation of Transgenic Fish
C 157 Anne Hudes & Stephen Ajay Vol#: 9
C 158 Rebecca L. Ramsay Vol#: 9
C 159 Dawn Mallow Vol#: 9
01P-0259 Refuse to approve tegaserod (Zelmac)
EMC 1 Gloria Swanson Vol#: 3
01P-0345 Listing the color additive yellow #5 for use in food/Drug
EMC 1 Alicia Waszczenko de Ramos Vol#: 1