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 December 21, 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 ]

 
98N-0337 Over the counter human drugs labeling requirements *
99F-5522 Ionizing radiation /control of Food-borne pathogens safe use *
00P-1322 Food Labeling and Allergen Contamination Control *
01N-0397 Transportation Safety & Potentially Sedating or Impairing *
01N-0496 Patient Profile Viewer *
01P-0320 Establish Format Standards for Ingredient Labels on Food Pro *

90N-0349 Hemoglobin & Perfluorocarbon-Based Oxygen Carriers

EMC 1 Joseph D. Mann MD Vol#: 1

94P-0354 Certify Mercury/Silver (amalgam)-Classify & Issue Warning

EC 1 Miss Wendy Daniels Vol#: 1

97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD

EMC 2 Timothy A. Heberling Vol#: 2

98N-0337 Over the counter human drugs labeling requirements

LET 10 HFD-560 to Zee Medical, Inc. Vol#: 8

99F-5522 Ionizing radiation /control of Food-borne pathogens safe use

C 5 Food Irradiation Processing Alliance Vol#: 1

00D-1538 Electronic Records; Electronic Signatures, Validation

C 9 GlaxoSmithKline Vol#: 5

00D-1543 Electronic Signatures: Glossary of Terms

C 6 GlaxoSmithKline Vol#: 5

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9620 Mary Foster Vol#: 476

C 9621 Mary Foster Vol#: 476

C 9622 Piere Guesmon Vol#: 476

00P-1322 Food Labeling and Allergen Contamination Control

EMC 462 Marie P. Tellefsen Vol#: 20

EMC 463 Phoenix Celiac Support Group Vol#: 20

00P-1411 Set a regulatory limit for methylmercury in seafood

EC 1 Ms. JOAN SANDOVALL Vol#: 2

01D-0489 Establishment & Operation of Clinical Trial Monitoring Comm

C 2 Marlies Van Hoef Vol#: 1

01N-0197 Treatment of Ankylosing Spondylitis and Related Disorders

C 6 Joachim Sieper Vol#: 1

01N-0256 Use of Opiate Analgesics in Various Patient Population inclu

EC 208 Mrs. Denise Steiner Vol#: 4

EC 209 Mr. James Signorile Vol#: 4

EC 210 Pain Center of Southern Indiana Vol#: 4

EC 211 Ms. Marian Noe Vol#: 4

EC 212 Mrs. Jennifer Gamble Vol#: 4

01N-0397 Transportation Safety & Potentially Sedating or Impairing

C 9 Consumer Healthcare Products Assn Vol#: 2

TR 1 Transcript of meeting held 11/14/01 Vol#: 4

TR 2 Transcript of meeting held 11/15/01 Vol#: 5

TS 16 PhRMA Vol#: 2

TS 17 PhRMA Vol#: 2

01N-0496 Patient Profile Viewer

APE 1 Merck & Co., Inc. Vol#: 1

01P-0320 Establish Format Standards for Ingredient Labels on Food Pro

C 156 Glenn and Phyllis Negley Vol#: 6

C 157 CSPI Vol#: 6

EMC 1 Krista Wasowski Vol#: 7

EMC 2 Linda Vanderlitz Vol#: 7

EMC 3 Rod Johnson Vol#: 7

EMC 4 Valerie Newpher Vol#: 7

EMC 5 Cheryl A. Sutcliffe Vol#: 7

EMC 6 Alan Slutsky Vol#: 7

EMC 7 Marilyn Adler Vol#: 7

EMC 8 Rachel Chambers Vol#: 7

EMC 9 William D. Sheets Vol#: 7

EMC 10 Don Gold Vol#: 7

EMC 11 Harriette Behringer and Family Vol#: 7

EMC 12 Tim and Gayle Mumma Vol#: 7

EMC 13 Robert McFarland Vol#: 7

EMC 14 Charlotte Neises Vol#: 7

EMC 15 Lesley Gradone Vol#: 7

EMC 16 Jayne Ripley Vol#: 7

EMC 17 Albert W. & Elizabeth A. Koster Vol#: 7

EMC 18 Terry M. Olsen Vol#: 7

EMC 19 Sheila Davis Vol#: 7

EMC 20 Bill Cain Vol#: 7

EMC 21 Nancy & Walter Johansson Vol#: 7

EMC 22 William R. Dufek Vol#: 7

EMC 23 Eileen Driscoll Vol#: 7

EMC 24 Raymond H. Chu Vol#: 7

EMC 25 Chris Eeckhout Vol#: 7

EMC 26 Joan Belluomini Vol#: 7

EMC 27 Marlene Maderer Vol#: 7

EMC 28 S. Mirlis Vol#: 7

EMC 29 Anne Eberle Vol#: 7

EMC 30 Ruth M. Pierce Vol#: 7

EMC 31 Marge Larson Vol#: 7

EMC 32 Norman Bowell Vol#: 7

EMC 33 Marshall Esty Vol#: 7

EMC 34 Aiden J. Humphrey Vol#: 7

EMC 35 no name Vol#: 7

EMC 36 Francine Belcik Vol#: 7

EMC 37 Marion Sachdeva Vol#: 7

EMC 38 Catherine Lautenbacher Vol#: 7

EMC 39 Aline D. Manzil Vol#: 7

EMC 40 Diane Wilson Vol#: 7

EMC 41 Peter M. Schaeffer Vol#: 7

EMC 42 Mary Ward Vol#: 7

EMC 43 Debbie Boggs Vol#: 7

EMC 44 Dave Lottier Vol#: 7

EMC 45 Drs. Ernest and Nancy Keith Vol#: 7

EMC 46 Tracy Andrews Vol#: 7

EMC 47 Dr. Itzcoatl Tlaloc Meztli Vol#: 7

EMC 48 Mark Chussil Vol#: 7

EMC 49 Joseph Kainer, Jr. Vol#: 7

EMC 50 Elizabeth Tucker Vol#: 7

EMC 51 Keilty Dalsis Vol#: 7

EMC 52 Rita A. Lethert Vol#: 7

EMC 53 Ronise C. Zenon Vol#: 7

EMC 54 Bill Showalter Vol#: 7

EMC 55 Leslie Meredith Vol#: 7

EMC 56 Charlotte & Harold Hostetler Vol#: 7

EMC 57 Julie Heironiums Vol#: 7

EMC 58 Carole T. Smelser Vol#: 7

EMC 59 Ame Heironimus-Ray Vol#: 7

EMC 60 Elma D. Holden Vol#: 7

EMC 61 R. W. Swaab Vol#: 7

EMC 62 Mr. Leigh Clark Vol#: 7

EMC 63 Cheryl Zuehlsdorff Vol#: 7

EMC 64 Beverely Dixon Vol#: 7

EMC 65 Roxanne Callahan Vol#: 7

EMC 66 Gail J. Reams Vol#: 7

EMC 67 Shirley & Richard H. Hoening Vol#: 7

EMC 68 Glynne Woolfenden Vol#: 7

EMC 69 Wanda Henao Vol#: 7

EMC 70 S. Freedman Vol#: 7

EMC 71 Edward Wright Vol#: 7

EMC 72 Norma L. Falla Vol#: 7

EMC 73 Rita DiMauro Vol#: 7

EMC 74 Michael Schulman Vol#: 7

EMC 75 Morton L. Zieve Vol#: 7

EMC 76 Eugene Parus Vol#: 7

EMC 77 John W. Cameron Vol#: 7

EMC 78 Marcia Monschein Vol#: 7

EMC 79 Vera Parent Vol#: 7

EMC 80 Dr. Alvin Arzt Vol#: 7

EMC 81 Alice J. Mees Vol#: 7

EMC 82 William C. Maxwell Vol#: 7

EMC 83 Edie Farm Vol#: 7

EMC 84 Karen Cannon Vol#: 7

EMC 85 Harry D. Corsover & Linda G. Azzi Vol#: 7

EMC 86 Harold C. Wiedemann Vol#: 7

EMC 87 Nikki Beller Vol#: 7

EMC 88 Margann Green Vol#: 7

EMC 89 Beverly Manor Vol#: 7

EMC 90 H. L. Wood Vol#: 7

EMC 91 Jacqueline Ng Vol#: 7

EMC 92 Daniel R. York Vol#: 7

EMC 93 Molly K. Barry Vol#: 7

EMC 94 Kathryn Bloise Vol#: 7

EMC 95 Janette Friel Vol#: 7

EMC 96 Joan Alexander Vol#: 7

EMC 97 Roger Carrillo Vol#: 7

EMC 98 Rachael E. Foster Vol#: 7

EMC 99 Barbara S. Bergman, Ph.D. Vol#: 7

EMC 100 Bryan Williamson Vol#: 7

EMC 101 Walter & Mona Grinspan Vol#: 7

EMC 102 Richard Santopietro Vol#: 7

EMC 103 Julie Stefanec Vol#: 7

01P-0345 Listing the color additive yellow #5 for use in food/Drug

EMC 847 Gordon Grant Vol#: 4

EMC 848 Jack Morrison Vol#: 4

EMC 849 Helen Turner Vol#: 4

EMC 850 Bronwyn van Summeren Vol#: 4

EMC 851 Susan Montano Vol#: 4

EMC 852 Mary A. Biddulph Vol#: 4

EMC 853 Jenny Saal Vol#: 4

EMC 854 Daniel Saal Vol#: 4

EMC 855 William Saal Vol#: 4

EMC 856 David Saal Vol#: 4

EMC 857 Lily Sexton Vol#: 4

EMC 858 Geoff Sexton Vol#: 4

EMC 859 Cheryl Cleere Vol#: 4

EMC 860 Elaine McDonald Vol#: 4

EMC 861 Mitchell Connor Vol#: 4

EMC 862 Ryan Connor Vol#: 4

EMC 863 Hayley Connor Vol#: 4

EMC 864 Andrew Connor Vol#: 4

EMC 865 Anne Connor Vol#: 4

EMC 866 Brendan Connor Vol#: 4

EMC 867 Debra Lang Vol#: 4

EMC 868 Frank & Jan Hobbs Vol#: 4

EMC 869 Betty Pfalzgraf Vol#: 4

EMC 870 Jennifer Pellicone Vol#: 4

EMC 871 Anne & Peter Blood-Patterson Vol#: 4

EMC 872 Chris A. Thurman-Gardner Vol#: 4

EMC 873 Alice A. Blanco Vol#: 4

EMC 874 Deborah Casswell Vol#: 4

EMC 875 Cheryl Whelan Vol#: 4

EMC 876 Alice Connell Vol#: 4

EMC 877 Kathryn Nordstrom Vol#: 4

EMC 878 Colette Spoard Vol#: 4

EMC 879 Karl Dahlke Vol#: 4

EMC 880 Denise J. Bowden Vol#: 4

EMC 881 Richard S. Bryson Vol#: 4

EMC 882 Wendy Dahlke Vol#: 4

EMC 883 Kelly Abraham Vol#: 4

EMC 884 Kelly Abraham Vol#: 4

EMC 885 Rebecca Banner Vol#: 4

EMC 886 Christy Milliken Vol#: 4

EMC 887 Shawn Badik Vol#: 4

EMC 888 Beth Hurst Vol#: 4

EMC 889 Rick Banner Vol#: 4

EMC 890 Katie Rizer Vol#: 4

EMC 891 Sally Byrd Vol#: 4

EMC 892 Tracey H. Wilson Vol#: 4

EMC 893 F. Rattay Vol#: 4

EMC 894 Gay Herpin Vol#: 4

EMC 895 Christina A. Kenyon Vol#: 4

EMC 896 Mandy Fenyvesi Vol#: 4

EMC 897 Amanda Fenyvesi Vol#: 4

EMC 898 Tracey Dickerson Vol#: 4

EMC 899 Pat Little Vol#: 4

EMC 900 Diane Fouts Vol#: 4

EMC 901 Amy Hedrick Vol#: 4

EMC 902 Wendie Breitenfeld Vol#: 4

EMC 903 Charles T. Wild Vol#: 4

EMC 904 Laura Palumbo Vol#: 4

EMC 905 Charles Thomas Wild Vol#: 4

EMC 906 Yaakov Bar-Nahman Vol#: 4

EMC 907 Goeff Boon Vol#: 4

EMC 908 Lenny Vol#: 4

EMC 909 D. Mills Vol#: 4

EMC 910 Frances Lawrence Vol#: 4

EMC 911 Luana L. Guymon Vol#: 4

EMC 912 Robyn Vol#: 4

EMC 913 Lisa Whiteford Vol#: 4

EMC 914 Alan Sloan Vol#: 4

EMC 915 Alexander Campbell Vol#: 4

EMC 916 Benjamin Campbell Vol#: 4

EMC 917 Samantha Campbell Vol#: 4

EMC 918 Elliott Campbell Vol#: 4

EMC 919 Rhonda Elms-Campbell Vol#: 4

EMC 920 Lara Hellingrath Vol#: 4

EMC 921 Todd Fouts Vol#: 4

EMC 922 Jackie Cook Vol#: 4

EMC 923 Mandy Kennedy Vol#: 4

EMC 924 Teresa Edmondson Vol#: 4

EMC 925 Laura Kessler Vol#: 4

EMC 926 Linda Gaebel Vol#: 4

EMC 927 Darrell Gaebel Vol#: 4

EMC 928 Heather Most Vol#: 4

EMC 929 Francie Mills Vol#: 4

EMC 930 Joan Gantz Vol#: 4

01P-0471 Issue the NFR Placement of Anthrax Vaccine as Category II

EMC 259 Dennis & Kelly Vonnahme Vol#: 2

EMC 260 Dominique Scott Vol#: 2

EMC 261 Reese Campbell Vol#: 2

EMC 262 James Raker Vol#: 2

EMC 263 Dr Jeffrey Aberle Vol#: 2

EMC 264 Susan Pearce Vol#: 2

EMC 265 Robert Vol#: 2

EMC 266 Robert Soska Vol#: 2

EMC 267 Rhonda Koon CNHP Vol#: 2

01V-0568 Laser Light Show

ACK 1 HFA-305 Vol#: 1