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Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870; TTY/TDD Users 1-800-735-2258 - [E-mail Us] DOCKETS ENTERED on November 5, 2002 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. |
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75N-183H Health-Care Antiseptic Drug Products for OTC Human Use
98P-0151 Introduction Of Downed Cattle Into The Food Supply
EMC 2906 Susan Osterman Vol#: 265
EMC 2907 Leah Hackenson-Allers Vol#: 265
EMC 2908 Sharyn Morris Vol#: 265
EMC 2909 Linda Johnson Vol#: 265
EMC 2910 Mr. D. L. Taylor Vol#: 265
EMC 2911 Delma S. Fleming, Ph.D. Vol#: 265
EMC 2912 Marian A. Kelner Vol#: 265
EMC 2913 Mrs. Keturah Johnson Vol#: 265
EMC 2914 Cowlover Vol#: 265
EMC 2915 Teresa J. Nunes & Samuel Taylor Vol#: 265
EMC 2916 Karen Bartell Vol#: 265
EMC 2917 number not used Vol#: 265
EMC 2918 E. Kinghorn (England) Vol#: 265
EMC 2919 Kim E. Johnson Vol#: 265
EMC 2920 pfoster Vol#: 265
EMC 2921 Vikki Lemke Vol#: 265
EMC 2922 Lucy Salazar Vol#: 265
EMC 2923 Jennifer Dubrule Vol#: 265
EMC 2924 Joanne M. North Vol#: 265
EMC 2925 Molly Anderson Vol#: 265
EMC 2926 Marilyn Ramos Vol#: 265
EMC 2927 Maria Montano Vol#: 265
EMC 2928 Elizabeth Niswander Vol#: 265
EMC 2929 Sharon Latta Vol#: 265
EMC 2930 J. Breslauer Vol#: 265
EMC 2931 Laura Redi Ph.D. Vol#: 265
EMC 2932 Shirley Allen Vol#: 265
EMC 2933 Cheryl & Peter Stone Vol#: 265
EMC 2934 Craig & Rebecca Bailey Vol#: 265
EMC 2935 Ronald & Janet Manning Vol#: 265
EMC 2936 Marjorie Hass Vol#: 265
EMC 2937 Kimberly Belkin Vol#: 265
EMC 2938 Stacie Dullmeyer Vol#: 265
EMC 2939 Joseph D'Angelo Vol#: 265
EMC 2940 Mike Perry Vol#: 265
EMC 2941 Betty Marano Vol#: 265
EMC 2942 Roxanne Baker Vol#: 265
EMC 2943 Michelle Corella Vol#: 265
EMC 2944 Nina Constantinou Vol#: 265
EMC 2945 Lorianna Ashlee Vol#: 265
EMC 2946 Sandra Nicholson Vol#: 265
EMC 2947 Darren Edwards Vol#: 265
EMC 2948 Kelly Jo Ernst Vol#: 265
EMC 2949 Lisa Kraft Vol#: 265
EMC 2950 Grace M. Holden Vol#: 265
EMC 2951 Arthur Szenczy Vol#: 265
EMC 2952 Miho Yamamoto Vol#: 265
EMC 2953 Rev. Terry Dorsey Vol#: 265
EMC 2954 Theresa & Robert Hopkins Vol#: 265
EMC 2955 Theresa Hopkins Vol#: 265
EMC 2956 Lisa Silvia Vol#: 265
EMC 2957 Taffy Lewis Vol#: 265
EMC 2958 Pamela Borres Vol#: 265
EMC 2959 Daniel Parnassa M.D. Vol#: 265
EMC 2960 John Carbone Vol#: 265
EMC 2961 Lydia M. Godfrey Vol#: 265
EMC 2962 Susan Rowley Vol#: 265
EMC 2963 Michael Harrington Vol#: 265
EMC 2964 Jean Carbone Vol#: 265
EMC 2965 John & Nancy Arnold Vol#: 265
EMC 2966 Catherine D. Mizerany Vol#: 265
EMC 2967 Ronnie Wright Vol#: 265
EMC 2968 Dr. Laurie Powell Vol#: 265
EMC 2969 Mrs. J. M. Caracci Vol#: 265
EMC 2970 Patti Bednarik Vol#: 265
EMC 2971 Margie Wilson Vol#: 265
EMC 2972 Susannah Naglee Vol#: 265
EMC 2973 Elise Pedersen Vol#: 265
EMC 2974 Nancy Lucas Vol#: 265
EMC 2975 April Lang Vol#: 265
EMC 2976 Nancy Vol#: 265
EMC 2977 Karla McBride Vol#: 265
EMC 2978 Jeanne Smith Vol#: 265
EMC 2979 Natascha Wiener Vol#: 265
EMC 2980 Danielle Sitnick Vol#: 265
EMC 2981 Yvonne Miles Vol#: 265
EMC 2982 April Lang Vol#: 265
EMC 2983 number not used Vol#: 265
EMC 2984 Arline K. Virgil Vol#: 265
EMC 2985 Melanie Magdinec, M.Ed., M.A. Vol#: 265
EMC 2986 Dr. & Mrs. Henry Hambel Vol#: 265
EMC 2987 Kristin Ferris Vol#: 265
EMC 2988 Morray Booth Cohen Vol#: 265
EMC 2989 Miguel Edwards Vol#: 265
01E-0091 Argatroban, Patent Extension Application No.5,214,052
LET 4 HFD-005 to US Patent & Trademark Office Vol#: 1
01E-0094 Calozal, Patent Extension Application No. 4,412,992
LET 4 HFD-5 to U.S. Patent and Trademark Offic Vol#: 1
01E-0403 Patent Term Extension Application; Valcyte No. 6,083,953
LET 2 HFD-005 to US Patent & Trademark Office Vol#: 1
01E-0405 Patent Term Extension Application, Evoxac No. 4,855,290
LET 4 HFD-5 to U.S. Patent & Trademark Office Vol#: 1
01E-0420 Patent Term Extension Application for Lotronex No. 5,360,800
LET 4 HFD-5 to U.S. Patent & Trademark Office Vol#: 1
01N-0067 Reclassification of Dental Mercury
C 117 Honorable Gordan H. Smith (CI) Vol#: 15
C 118 Honorable Larry Combest (CI) Vol#: 15
02D-0324 Bioengineered Plants for Use in Humans and Animals
C 3 Gail Souther Vol#: 1
C 4 Grace N. Smith & Allyn B. White Vol#: 1
C 5 Eugene Jordan Vol#: 1
C 6 Geradine Martinea Vol#: 1
C 7 Carol Crenshaw Vol#: 1
C 8 Louis S. Campbell Vol#: 1
C 9 Jeffri H. Frontz Vol#: 1
C 10 Barbara Leibundguth Vol#: 1
C 11 Wallace B. Eubanks Vol#: 1
02D-0333 Juice HACCP Hazards and Controls
02E-0021 Patent Term Application for Hyperion LTK Sys. No. 4,976,709
LET 2 HFD-005 to US Patent & Trademark Office Vol#: 1
02E-0022 Patent Term Application for Solage No. 5,194,247
LET 4 HFD-5 to U.S. Patent & Trademark Office Vol#: 1
02E-0024 Patent Term Application for Gleevac No. 5,521,184
LET 4 HFD-5 to U.S. Patent & Trademark Office Vol#: 1
02E-0100 Patent Application for Dutrasteride
LET 2 HFD-005 to US Patent & Trademark Office Vol#: 1
02E-0147 Patent Extension 5,258,494, OP-1 Implant
LET 2 HFD-005 to US Patent & Trademark Office Vol#: 1
02E-0149 Genesis Neurostimulation System, U.S. Patent No. 4,793,353
LET 2 HFD-005 to US Patent & Trademark Office Vol#: 1
02E-0150 Gynecare Intergel, U.S. Patent Extension No. 5,532,221
LET 2 HFD-005 to US Patent & Trademark Office Vol#: 1
02E-0156 Galileo Intravascular Radiotherapy System
LET 2 HFD-005 to US Patent & Trademark Office Vol#: 1
02E-0345 Patent Term Application for Aromanis No. 4,808,616
LET 2 HFD-005 to US Patent & Trademark Office Vol#: 1
02N-0276 Bioterrorism Preparedness;Registration of Food Facilities
EC 32 Fedeoliva USA, LTD Vol#: 3
02N-0305 Dental Sonography Device & Jaw Tracking Device
EC 1 Ms. annette williams Vol#: 1
02N-0417 Applications for FDA Approval to Market a New Drug
C 1 David Eichenauer Vol#: 1
02N-0445 FDA Regulation of Combination Products; Public Hearing
EAPE4 The Weinberg Group Vol#: 2
EAPE5 Johnson and Johnson Vol#: 2
EAPE8 American Red Cross Vol#: 2
EAPE11 Hyman, Phelps & McNamara, P.C. Vol#: 2
EAPE13 Merck Research Laboratories Vol#: 2
EAPE14 Patton Boggs LLP Vol#: 2
EAPE15 Meretek Diagnostics Vol#: 2
EAPE16 W.L. Gore & Associates, Inc. Vol#: 2
EAPE17 National Electrical Manufacturers Associ Vol#: 2
EAPE18 Chrysalis Technologies, Inc. Vol#: 2
EAPE19 Chrysalis Technologies, Inc. Vol#: 2
EAPE20 Altea Development Inc. Vol#: 2
EAPE21 Tom Steinke Research Company Vol#: 2
EAPE23 FDA/CDER/OPS/OGD/HFD 600 Vol#: 2
EAPE24 Hoffmann-La roche Vol#: 2
EC 1 Mr. Tom Hite Vol#: 1
02N-0466 Safety, Clinical and Immune Response of Dryvax
EC 1 Ms. Linda Wientjes Vol#: 3
EC 2 Terre Pharmaceuticals Vol#: 3
EC 4 University of California Vol#: 3
EC 5 Kaiser Permanente Vol#: 3
EC 6 Mr. Laurence Skopitz Vol#: 3
EC 8 Mr. Bruce Shaver Vol#: 3
EC 9 Mrs. Dawna Immele Vol#: 3
EC 10 Ms. Kelly Smith Vol#: 3
EC 11 Mr. Carl Maass Vol#: 3
EC 12 none Vol#: 3
EC 13 Ms. Lynne Crandall Vol#: 3
EC 14 Ms. Marcia Brown Vol#: 3
EC 15 Ms. Amy Donovan Vol#: 3
EC 16 childrens hospital, boston, ma Vol#: 3
EC 17 Ms. Stephanie Massengale Vol#: 3
EC 18 Mrs. Holly Case Vol#: 3
EC 19 Mrs. Debra Picarello Vol#: 3
EC 20 Mr. John Huempfner Vol#: 3
EC 21 Mrs. Dee Sessom Vol#: 3
EC 22 none Vol#: 3
EC 23 Mrs. Lorraine Kennedy Vol#: 3
EC 24 Ms. Anne Thrope Vol#: 3
EC 25 Mrs. Helen Cashell Vol#: 3
EC 26 Carilion Roanoke Memorial Hospital Vol#: 3
EC 27 Mrs. Kyrsten Laboda Vol#: 3
EC 28 Mr. Carlos Calderon Vol#: 3
EC 29 Ms. Holly Snelgrove Vol#: 3
EC 30 Dr. Jeannette Carty Vol#: 3
EC 31 Mrs. Kari Vacura Vol#: 3
EC 32 Ms. Andrea Webster Vol#: 3
EC 33 International Network for History of Pub Vol#: 3
EC 34 Mr. Bill Saunders Vol#: 3
EC 35 Mrs. MARY WISHON Vol#: 3
EC 36 Mrs. Brenda Carus Vol#: 3
EC 37 Mrs. Julie Gonzales Vol#: 3
EC 38 Center for Health Care Rights Vol#: 3
EC 39 Mrs. sandra hamilton Vol#: 3
EC 40 Mr. Brad Ainslie Vol#: 3
EC 41 Uniformed Services University Vol#: 3
EC 42 none Vol#: 3
EC 43 Mrs. Donna Bachman Vol#: 3
EC 44 Mrs. Erica Miles Vol#: 3
EC 45 Ms. Patricia Berrian - Marrujo Vol#: 3
EC 46 Ms. L Gorman Vol#: 3
EC 47 Ms. P. Seay Vol#: 3
EC 48 Texas A&M University-Commerce Vol#: 3
EC 49 Texas Dept. of Health Vol#: 3
EC 50 Mrs. Lisa Doyon Vol#: 3
EC 51 Mrs. Lara Climer Vol#: 3
EC 52 n/a Vol#: 3
EC 53 student at the University of Vermont Vol#: 3
EC 54 Mrs. lisa Campbell Vol#: 3
EC 55 ` Vol#: 3
EC 56 Ms. Karen Olson Vol#: 3
EC 57 Mrs. Phyllis Ehlers Vol#: 3
EC 58 Ms. Donna Hoaglin Vol#: 3
EC 59 Mrs. Kathy Ratkiewicz Vol#: 3
EC 60 Ms. Teresa Mueller Vol#: 3
EC 61 Mrs. Cathleen Baker Vol#: 3
EC 62 Ms. Valerie Holloway Vol#: 3
EC 63 Riverside Chiropractic & Vitality Center Vol#: 3
EC 64 Mrs. Catherine Ann Jurs Vol#: 3
EC 65 Mrs. Laura Austin Vol#: 3
EC 66 Mrs. Jennifer McAnally Vol#: 3
EC 67 home Vol#: 3
EC 68 Mrs. shasta wiley Vol#: 3
EC 69 American Indian Cultural Support Vol#: 3
EC 70 Mrs. Carol AnCel Vol#: 3
EC 71 Mrs. Jennifer Pribil Vol#: 3
EC 72 Mr. Adam Vance Vol#: 3
EC 73 Dr. Richard Coy Vol#: 3
EC 74 Mrs. Phyllis Parmelee Vol#: 3
EC 75 Mrs. Maci Cozart Vol#: 3
EC 76 n/a Vol#: 3
EC 77 Mrs. Dolores Jackson Vol#: 3
EC 78 Dr. Michael Pardis Vol#: 3
EC 79 Mrs. Jean Kennedy Vol#: 3
EC 80 Mrs. Kathryn Warren Vol#: 3
EC 81 Mrs. PATRICIA SKAHILL Vol#: 3
EC 82 Mrs. Diane Willcutts Vol#: 3
EC 83 Mr. Jay Goldwein Vol#: 3
EC 84 Ms. Katherine Carbone Vol#: 3
EC 85 Mrs. Kathy Bolmida Vol#: 3
EC 86 Miss Shannon Drinkwine Vol#: 3
EC 87 n/a Vol#: 3
EC 88 Mrs. Rene Schneider Vol#: 3
EC 89 Miss Christine Buckley Vol#: 3
EC 90 Mrs. Tammy Retherford Vol#: 3
EC 91 Mrs. Kym Wright Vol#: 3
EC 92 Ms. Florence Wiley Vol#: 3
EC 93 Dr. Kenneth Pickover Vol#: 3
EC 94 Mr. Robert Vircks Vol#: 3
EC 95 Mrs. Tonya Siltman Vol#: 3
EC 96 Miss jessica petersen Vol#: 3
EC 97 Hospital of the University of Pennsylvan Vol#: 3
EC 98 Ms. Michelle Dawson Vol#: 3
EC 99 Number Not Used Vol#: 3
EC 100 Portmsouth Early Education Vol#: 3
EC 101 Portmsouth Early Education Vol#: 3
EC 102 Portsmouth Early Education Program Vol#: 3
EC 103 Self Vol#: 3
EC 104 Dr. jeffry Finnigan Vol#: 3
EC 105 Ms. Nancy Hokkanen Vol#: 3
EC 106 Mrs. Ruth Marten Vol#: 3
EC 107 Miss diane gallant Vol#: 3
EC 108 Mr. Michael Goldberg Vol#: 3
EC 109 Individual Vol#: 3
EC 110 Ms. Mary Hughes Vol#: 3
EC 111 Miss Diana Hom Vol#: 3
EC 112 Ms. Michele Kangas Vol#: 3
EC 113 Nursing Student Vol#: 3
EC 114 Mr. jeffrey roston Vol#: 3
EC 115 Mrs. Nina Doyle Vol#: 3
EC 116 Mrs. linda frazee Vol#: 3
EC 117 Mrs. Carol Ondracek Vol#: 3
EC 118 Dr, Karen Hammel, DC Vol#: 3
EC 119 american citizen Vol#: 3
EC 120 Mrs. Carrie Baert Vol#: 3
EC 121 Mrs. Susan Carfagno Vol#: 3
EC 122 Ms. Kelly Kondrup Vol#: 3
EC 123 Mrs. Sarah Peterson Vol#: 3
EC 124 Mr. Abram Lot Vol#: 3
EC 125 Mr. William Tell Vol#: 3
EC 126 Dr. Brian Lieberman Vol#: 3
EC 127 Ms. G. Denham Vol#: 3
EC 128 Knowledge of Health, Inc. Vol#: 3
EC 129 Mrs. Kelly Vetter Vol#: 3
EC 130 Dr. Peter Rickards Vol#: 3
EMC 1 Mary Tiernan Vol#: 1
EMC 2 KillerBee Vol#: 1
EMC 3 Anonymous Vol#: 1
EMC 4 Riobil Vol#: 1
EMC 5 Elizabeth Porter Vol#: 1
EMC 6 Jerry Hurley Vol#: 1
EMC 7 Lynn Gorman Vol#: 1
EMC 9 Mark Friedman Vol#: 1
EMC 10 Earl Kearly Vol#: 1
EMC 11 Tracie Bork Vol#: 1
EMC 12 Jeanne Willig Vol#: 1
EMC 13 Webnori Vol#: 1
EMC 14 Eric Blackburn Vol#: 1
EMC 15 David E Parsons Vol#: 1
EMC 16 Wendy Callahan Vol#: 1
EMC 17 EagleseyeFlight Vol#: 1
EMC 18 Joyce Rachum Vol#: 1
EMC 19 Wisteria Haines Vol#: 1
EMC 20 Jan Woodard Vol#: 1
EMC 21 Jane Tier Vol#: 1
EMC 22 LttlPuddin Vol#: 1
EMC 23 Robin Stone Vol#: 1
EMC 24 Linda K Reyes Vol#: 1
EMC 25 Jill Buschmann Vol#: 1
EMC 26 John Wallis Vol#: 1
EMC 27 Jody B Spitale Vol#: 1
EMC 28 Julie Plunkett Vol#: 1
EMC 29 Judith and Albert Gerber Vol#: 1
EMC 30 Al Wilson Vol#: 1
EMC 31 Sue McNally Vol#: 1
EMC 32 Michael Goll Vol#: 1
EMC 33 Tristene & Jason Vol#: 1
EMC 34 Brennan Cassidy Vol#: 1
EMC 35 Kelly J Meerdink Vol#: 1
EMC 36 Cary & Judy Campbell Vol#: 1
02P-0122 Request Rulemaking on Functional Foods & Establish Adv. Com.
02P-0211 Amend 21CFR163,"Cacao Products: Stds of Identity"
LET 1 HFS-800 to American Environmental Safety Vol#: 1
02P-0478 Fentanyl transdermal system 12.5 mcg/hr is suitable for ANDA