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 March 28, 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 your correspondence.

[FDA DOCKETS PAGE] [FDA HOME PAGE]  [ ITEM CODES ]

 
93N-0372 Medical Devices; Hearing Aid Requirements *
98D-0997 Metered dose Inhaler and Dry Powder Inhaler Drug Products *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00D-1681 Potassium Iodide as a Thyroid Blocking Agent *
00N-0989 Human Gene Therapy *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1322 Food Labeling and Allergen Contamination Control *
00P-1602 Remove Unapproved Children's Fluoride Supplements from Mkt *
01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC *
01P-0083 Disclosure Source of Premarin *

93N-0372 Medical Devices; Hearing Aid Requirements

C 5026 Miracle-Ear Vol#: 118

C 5027 Belmar Hearing Aid Center Vol#: 118

C 5028 Wendy Hafele Vol#: 118

C 5029 Tri-County Audiology & Hearing Aid Ser Vol#: 118

C 5030 Beltone Hearing Care Center Vol#: 118

C 5031 Tri-County Audiology & Hearing Aid Ser Vol#: 118

C 5032 Beltone Vol#: 118

C 5033 Mary Lou Lauster Vol#: 118

C 5034 Margaret James Vol#: 118

C 5035 Sophie Farah Vol#: 118

98D-0997 Metered dose Inhaler and Dry Powder Inhaler Drug Products

C 26 Alexis M Milmine Vol#: 3


98P-0151 Introduction Of Downed Cattle Into The Food Supply

C 4314 Rebecca J. Altman Vol#: 136

C 4315 K B Vol#: 136

C 4316 Elizabeth Gingery Vol#: 136

C 4317 Sonja Kassal Vol#: 136

C 4318 Basic Pet Care Animal Hospital Vol#: 136

C 4319 Yvonne Haik, MA, LP Vol#: 136

C 4320 Lydia C. Giglio, Ph.D. Vol#: 136

C 4321 Lydia C. Giglio, Ph.D. Vol#: 136

C 4322 Lydia C. Giglio, Ph.D. Vol#: 136

C 4323 Linda Van Den Bussche Vol#: 136

C 4324 Public Citizen Vol#: 136

C 4325 Mrs. M. Grant. Vol#: 137

C 4326 Laurel Lyall Vol#: 137

C 4327 Jean Fitch Jones Vol#: 137

C 4328 Theresa Amundson Vol#: 137

C 4329 no signature Vol#: 137

C 4330 Emma Huenegaard Vol#: 137

C 4331 Barbara E. Church Vol#: 137

C 4332 Ms. Jami Tolpin Vol#: 137

C 4333 Phyllis Kissner Vol#: 137

C 4334 LuAnn Howell Vol#: 137

C 4335 Ronny Gibbons Vol#: 137

C 4336 Ms. Elisabeth Peterson Vol#: 137

C 4337 Humane Education Network Vol#: 137

C 4338 Deanna S. Devaul Vol#: 137

C 4339 Mrs. Herbert W. Abbott Vol#: 137

C 4340 Michael Karpack Vol#: 137

C 4341 Arnold P. Vol#: 137

C 4342 Clara S. Vol#: 137

C 4343 Jim Bowers Vol#: 137

C 4344 Ezra Selman Vol#: 137

C 4345 Mr. Adolfo Lopez Vol#: 137

C 4346 Chelsea Sutherland Vol#: 137

C 4347 Mr. Lowell Shipwash Vol#: 137

C 4348 Hazel L. Pockler Vol#: 137

C 4349 Joan B. Richardson Vol#: 137

C 4350 Dorothy Finger Vol#: 137

C 4351 Judy Fichter Vol#: 137

C 4352 Mark J. & Jennifer Christiano Michaud Vol#: 137

C 4353 Basic Pet Care Animal Hospital Vol#: 137

C 4354 Lori Dority Vol#: 137

C 4355 Danila B. Oder Vol#: 137

C 4356 Nancy Tropin Vol#: 137

C 4357 Joan M. Kurtz Vol#: 137

C 4358 Deborah Lyons Vol#: 137

C 4359 Robin Ondeck Vol#: 137

C 4360 Natasha L. Gontesky Vol#: 137

C 4361 Mrs. W. Schweitzer Vol#: 137

C 4362 Stephanie Blythe Vol#: 137

C 4363 AnnMarie Miller Vol#: 137

C 4364 Bill Carleen Boehl Vol#: 137

C 4365 Tom Runnerow Vol#: 137

C 4366 Elinore Gordon Vol#: 137

C 4367 Mr. Irving Applebaum Vol#: 137

C 4368 Carolisa Morgan Vol#: 137

C 4369 Frances W. Stevenson Vol#: 137

C 4370 Elizabeth Sharman Vol#: 137

C 4371 Shirley L. Shepard Vol#: 137

C 4372 Aileen Siracusa Vol#: 137

C 4373 Marianne Wainwright Vol#: 137

C 4374 Maureen Lynch Vol#: 137

C 4375 Diana Garcia Vol#: 137

C 4376 Anthony DelGreco Vol#: 137

EMC 1588 Andrea Chadima Vol#: 137

EMC 1589 Tracy Vol#: 137

EMC 1590 Monica Lucas Vol#: 137

EMC 1591 John Kesich Vol#: 137

EMC 1592 Tracy Doherty Vol#: 137

EMC 1593 T. Baino Vol#: 137

EMC 1594 Ms. Judy Mason Vol#: 137

EMC 1595 J. Anthony Vol#: 137

EMC 1596 Richard B. Stinnette Vol#: 137

EMC 1597 Christopher Coen Vol#: 137

EMC 1598 Mayers Vol#: 137

EMC 1599 Kirvin Satterwhite Vol#: 137

EMC 1600 Elizabeth Keating Vol#: 137

EMC 1601 Margot Kuhre Vol#: 137

EMC 1602 Laura Samakese (Canada) Vol#: 137

EMC 1603 Connie B. Durkee Vol#: 137

EMC 1604 Lynette Dumont Vol#: 137

EMC 1605 Jessica Kane Vol#: 137

EMC 1606 Herman Landman Vol#: 137

EMC 1607 John H. Kelly, Jr., M.D., MPH Vol#: 137

EMC 1608 Dr. David E. Hochtritt Vol#: 137

EMC 1609 Hans Gilgen Vol#: 137

EMC 1610 Michelle L. Rickson Vol#: 137

EMC 1611 Nancy Furstinger Vol#: 137

EMC 1612 Alison Gollup Vol#: 137

EMC 1613 John F. Doorish Vol#: 137

LET 5 RDAD/Office of Policy, Program Developme Vol#: 136


99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 2921 COEJL/SC Vol#: 205

C 2922 Leslie L Rolik Vol#: 205

C 2923 Sister Marie Diebold Vol#: 205

C 2924 Lynn Colwell Vol#: 205

C 2925 Cathy Kimball Vol#: 205

C 2926 Dr G P Bertoni Vol#: 205

C 2927 John Buchanan & 16 signatures Vol#: 205

EMC 602 LaDonna Smith Vol#: 204

EMC 603 Ingrid Lundahl Vol#: 204

EMC 604 Mary Stone Vol#: 204

EMC 605 NUMBER NOT USED Vol#: 204

EMC 606 Gaybra Raymond Vol#: 204

EMC 607 NUMBER NOT USED Vol#: 204

EMC 608 Ian Boardman Vol#: 204

EMC 609 NUMBER NOT USED Vol#: 204

EMC 610 Sue Donora Vol#: 204

EMC 611 NUMBER NOT USED Vol#: 204

EMC 612 Bernadette Rosenstiel Vol#: 204

EMC 613 M P Vol#: 204

EMC 614 Diane Lake Vol#: 204

EMC 615 Malcolm Kenton Vol#: 204

EMC 616 Eleanor W Helper Vol#: 204

EMC 617 Kristin Doubet Vol#: 204

EMC 618 Heather Plattenberger Vol#: 204

EMC 619 Cara Emery Vol#: 204

EMC 620 Laura Stucin Vol#: 204

EMC 621 Wendie Lash Vol#: 205

EMC 622 Philip Berlier Vol#: 205

EMC 623 Anne Ulmer Vol#: 205

EMC 624 Elizabeth Westphal Vol#: 205

EMC 625 Carla Pickett Vol#: 205

EMC 626 Pete Kallinger Vol#: 205

EMC 627 Jean Rohrer Vol#: 205

EMC 628 Gerard Cookson Vol#: 205

EMC 629 Ski Taylor Vol#: 205

EMC 630 Linda Martinek Vol#: 205

EMC 631 Christopher Coen Vol#: 205

EMC 632 Adrian Deckbar Vol#: 205

EMC 633 Michael Styers Vol#: 205

EMC 634 David Benson Vol#: 205

EMC 635 Kitty McCague Vol#: 205

EMC 636 E B Wireman Vol#: 205

EMC 637 Nadine Scott Vol#: 205

EMC 638 Frederica B Neal Vol#: 205

EMC 639 Deborah Wool Vol#: 205

EMC 640 Melinda Routh Vol#: 205

EMC 641 Raymond Chavira Vol#: 205

EMC 642 Don & Norma Boswell Vol#: 205

EMC 643 Sharon Voirin Vol#: 205

EMC 644 Romaine Orthwein Vol#: 205


00D-1598 Voluntary Labeling for Bioengineered Foods

C 669 The Ahern Wild Family Vol#: 78

C 670 Sheri Knapp-Schepker Vol#: 78

C 671 Vicki Dunaway Vol#: 78

C 672 Joanne Holbrook Vol#: 78

C 673 Jeffrey Grey Vol#: 78

C 674 Marilyn Anderson Vol#: 78

C 675 Rich Hilsinger Vol#: 78

C 676 Mary Pat Champean Vol#: 79

C 677 Etel Thomas Vol#: 79

C 678 Marc Bellenoit Vol#: 79

C 679 Mary Duncan Vol#: 79

C 680 Randy Eckard Vol#: 79

C 681 Sarah E. McCarthy Vol#: 79

C 682 Paul Fchribach Vol#: 79

C 683 Elizabeth Heepe Vol#: 79

EMC 1682 Robin Grae Vol#: 79

EMC 1683 Kalleen Henderson Vol#: 79

EMC 1684 Seppe Wiesmueller Vol#: 79

EMC 1685 Marc & Anita Loiselle Vol#: 79

EMC 1686 Dennis Elsen Vol#: 79

EMC 1687 Lynne Starrett Vol#: 79

EMC 1688 Paul Gaumond Vol#: 79

EMC 1689 Kevin O'Dare Vol#: 79

EMC 1690 Annie Decker Vol#: 79

EMC 1691 Makyla Waters Vol#: 79

EMC 1692 B. Robin Dery Vol#: 79

EMC 1693 Dr. Mary E. Friel Vol#: 79

EMC 1694 Joan Siegel Vol#: 79

EMC 1695 Anne Rossen Vol#: 79

EMC 1696 Todd Williams Vol#: 79

EMC 1697 Keli Tucker Vol#: 79

EMC 1698 Monique Harrison Vol#: 79

EMC 1699 Lauren Panos Vol#: 79

EMC 1700 D. Leonard Vol#: 79

EMC 1701 Heather M. Johnson Vol#: 79

EMC 1702 Sarah Webb Vol#: 79

EMC 1703 Pamela S. Long Vol#: 79

EMC 1704 John Thielking Vol#: 79

EMC 1705 Mary Roche Vol#: 79

EMC 1706 Erin Johnson Vol#: 79

EMC 1707 Anna Preble Vol#: 79

EMC 1708 Matt Hubin Vol#: 79

EMC 1709 Matthew Hublin Vol#: 79

EMC 1710 Stephanie Ferguson Vol#: 79

EMC 1711 Amy Kremen Vol#: 79

EMC 1712 Jason Nash Vol#: 79

EMC 1713 Jack Ladwig Vol#: 79

EMC 1714 Shari Wildschutte Vol#: 79

EMC 1715 Laura M. Ohanian Vol#: 79

EMC 1716 Roy Gottlieb Vol#: 79

EMC 1717 Michelle Lee Vol#: 79

EMC 1718 Jeraldine Rosenthal Vol#: 79

EMC 1719 Oren Rosenthal Vol#: 79

EMC 1720 Emily Rosenthal Vol#: 79

EMC 1721 Donna Theall Vol#: 79

EMC 1722 Brien Brennan Vol#: 79

EMC 1723 Matt Meyers, MPH Vol#: 79

EMC 1724 Mariah Neary Vol#: 79

EMC 1725 Mike Simonet Vol#: 79

EMC 1726 Sean Sacks Vol#: 79

EMC 1727 Kim Marie Morris Vol#: 79

EMC 1728 Marlow Rodale Vol#: 79

EMC 1729 K. Hedberg Vol#: 79

EMC 1730 Mary Rubach Vol#: 79

EMC 1731 Lisa Griffiths Vol#: 79

EMC 1732 Valerie Byxbe Vol#: 79

EMC 1733 Sandy Diller Vol#: 79

EMC 1734 Sylvia Bryan Vol#: 79

EMC 1735 Annette Weissbach Vol#: 79

EMC 1736 Norman Ben-Maor Vol#: 79

EMC 1737 Kurt Nilson Vol#: 79

EMC 1738 Paul Ballora Vol#: 79

EMC 1739 Ben Paulos Vol#: 79

EMC 1740 Karey Shawe Vol#: 79

EMC 1741 Cory Gassmann Vol#: 79

EMC 1742 Raymond & Gretchen Moyer Vol#: 79

EMC 1743 Mark Lipsman Vol#: 79

EMC 1744 Tasha Harmon Vol#: 79

EMC 1745 Barbara Durfee Vol#: 79

EMC 1746 Man-Li Kuan Vol#: 79

EMC 1747 Robin Means Vol#: 79

EMC 1748 Cass Passmore Vol#: 79

EMC 1749 Jeff Derant Vol#: 79

EMC 1750 Cheyenne Hughes Vol#: 79

EMC 1751 Sandy Glassman Vol#: 79

EMC 1752 David Drinnan Vol#: 79

EMC 1753 Robert Hovey Vol#: 79

EMC 1754 Carol Cameron Vol#: 79

EMC 1755 Pat Crocker Vol#: 79

EMC 1756 Wendy Valender Vol#: 79

EMC 1757 Rachel DiCerbo Vol#: 79

EMC 1758 Sara Qureshi Vol#: 79

EMC 1759 Rob Means Vol#: 79

EMC 1760 Greg Cromwell Vol#: 79

EMC 1761 Ann Phillips Vol#: 79

EMC 1762 Priscilla Pedroza Vol#: 79

EMC 1763 Florence Fiaui-Davis Vol#: 79

EMC 1764 Karen Fordyce Vol#: 79

EMC 1765 Bob Schulof Vol#: 79

EMC 1766 Melinda Viren Vol#: 79

EMC 1767 Adam Pizer Vol#: 79

EMC 1768 Hayat Nancy Abuza Vol#: 79

EMC 1769 Susan Clarke Vol#: 79

EMC 1770 Elaine Marie Keene Vol#: 79

EMC 1771 Elizabeth Johnson Vol#: 79

EMC 1772 Susan Spang Vol#: 79

EMC 1773 Kirsten Liske Vol#: 79

EMC 1774 Sharon Dalton Vol#: 79

EMC 1775 Nicholai Matro Vol#: 79

00D-1681 Potassium Iodide as a Thyroid Blocking Agent

C 4 CRCPD' Inc Vol#: 1

00N-0989 Human Gene Therapy

C 21 M J Bonazzoli & Family Vol#: 3

C 22 Marilyn L Furlano Vol#: 3

C 23 L C Diglio PhD Vol#: 3

C 24 J Capizzelli Vol#: 3

C 25 D Hachiet Vol#: 3

C 26 Mrs J Saeva Vol#: 3

C 27 Nazen Merjian Vol#: 3

C 28 Larry L Miller Vol#: 3

C 29 Joseph Zuwatsky Vol#: 3

C 30 Richard Fielding Vol#: 3

C 31 Deborah Lyons Vol#: 3

C 32 AnnMarie Miller Vol#: 3

C 33 Diana Garcia Vol#: 3

C 34 D Nuzzo Vol#: 3

C 35 Ursula Palenik Vol#: 3

C 36 Traude Buckland Vol#: 3

C 37 Sheryl J Street Vol#: 3

EMC 111 Arezoo Rahmim Vol#: 3

EMC 112 Herman Landman Vol#: 3

EMC 113 Monica Jankowski Vol#: 3

EMC 114 Joan Jasper Vol#: 3

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 9168 John Sullivan Vol#: 722

C 9169 Paula James Vol#: 722

C 9170 Jude Nagurney Vol#: 722

C 9171 Will Gentz Vol#: 722

C 9172 Cynthia Kokis Vol#: 722

C 9173 Penelope Garner Vol#: 722

00P-1322 Food Labeling and Allergen Contamination Control

LET 2 HFS-24 to Pat Potok Vol#: 2

00P-1602 Remove Unapproved Children's Fluoride Supplements from Mkt

C 8 Helen Dutmer Vol#: 1

01N-0078 Assessment of Physician & Patient Attitudes Toward Direct-to

BKG 1 Background Material Vol#: 1

BKG 2 Background Material Vol#: 1

01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC

C 26 Harold K. Riches, D.O & Theresa Pardoe,D Vol#: 3

C 27 Michael J. Jenkins Vol#: 3

01P-0083 Disclosure Source of Premarin

C 1 Joanne G Mainiero Vol#: 1

C 2 Form Letter count 144 Vol#: 2

C 3 Betty Supaski Vol#: 1

Page Update September 8, 2003 jb