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 October 27, 2000

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 ]

 
78N-0301 OTC External Analgesic Drug Products *
94D-0025 Interim GDL/Labeling Milk & Milk Products from Cows w/rbST *
95D-0349 Immediate Release Solid Oral Dosage Forms;Scale-Up & Postapr *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99P-1340 Declared Eternity eau de Parfum Misbranded *
00D-0186 M4 Common Technical Document;InterNatl Confern on Harmonisat *
00D-1350 Combined Oral Contraceptives/Labeling/Healthcare Providers *
00D-1384 Physical Examination of Surgeons' &/or Patient Exam Gloves *
00D-1392 Guidance for Industry on Botanical Drug Products *
00D-1418 Q7A ICH Good Manufacturing Practice Guide for Active Pharmac *
00D-1455 Premarket Notification for Totally Implanted Spinal Cord *
00D-1497 Mammography Quality Standards Act; Final Regs Document #4 *
00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair *
00N-1460 Salmonella Enteritidis Research Public Meeting *
00P-1210 Restrict Sale of Coal Tar-Containing Products *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1263 Initiation of Procedure to Determine Whether DHEA is exclude *

78N-0301 OTC External Analgesic Drug Products

EXT 2 Chattem Inc Vol#: 99

94D-0025 Interim GDL/Labeling Milk & Milk Products from Cows w/rbST

C 8562 K Gill Vol#: 116

95D-0349 Immediate Release Solid Oral Dosage Forms;Scale-Up & Postapr

C 20 Fluid Air Inc Vol#: 3

95N-0220 Substances Appoved use in Preparation Meat/Poultry Products

M 1 HF-11 Vol#: 1

98N-0337 Over the counter human drugs labeling requirements

ANS 10 HFD-560 to Whitehall-Robins Healthcare Vol#: 6

APP 11 L Perrigo Company Vol#: 6

APP 12 L Perrigo Company Vol#: 6

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

C 2360 P. Tice Vol#: 68

C 2361 J. Jacobs Vol#: 68

C 2362 M Moore Vol#: 68

C 2363 F. Evans Vol#: 68

C 2364 G. Bezdek Vol#: 68

C 2365 Y. Ciccone Vol#: 68

C 2366 D. Aranda Vol#: 68

C 2367 Y. Torsiello Vol#: 68

C 2368 Mrs. J Saeva Vol#: 68

C 2369 C Jaris Vol#: 68

C 2370 E. Morales Vol#: 68

C 2371 M Raynis Vol#: 68

C 2372 A Buchter Vol#: 68

C 2373 G Schumann Vol#: 68

C 2374 S Ewing Vol#: 68

C 2375 D Arancio Vol#: 68

C 2376 D. MacVean Vol#: 68

C 2377 S Avis et al Vol#: 68

C 2378 P Hoffman Vol#: 68

C 2379 J Weyhrauch Vol#: 68

C 2380 M. Johnson Vol#: 68

C 2381 Voices for Animals Vol#: 68

C 2382 C Anderlik Vol#: 68

C 2383 M. Gates Vol#: 68

C 2384 A. Noonan Vol#: 68

C 2385 M King Vol#: 68

C 2386 A Tuchalski Vol#: 68

EMC 70 A Ellis Vol#: 68

EMC 71 N Badia Vol#: 68

EMC 72 J Fantuz Vol#: 68

EMC 73 K. Crupi Vol#: 68

EMC 74 S Figueroa Vol#: 68

EMC 75 A Economou Vol#: 68

EMC 76 B Caramante Vol#: 68

EMC 77 E Ehrhardt Vol#: 68

EMC 78 S Dahl Vol#: 68

EMC 79 C Wilkins Vol#: 68

EMC 80 S Hearn Vol#: 68

EMC 81 S Dosapati Vol#: 68

EMC 82 D Ellis Vol#: 68

EMC 83 D Sichner Vol#: 68

EMC 84 B Towles Vol#: 68

EMC 85 J Janicki Vol#: 68

EMC 86 G Atlee Vol#: 68

EMC 87 H Sorrenson Vol#: 68

EMC 88 M. Hollabaugh Vol#: 68

EMC 89 Siensk Vol#: 68

EMC 90 E Sundstrom Vol#: 68

EMC 91 J Kabas Vol#: 68

EMC 92 P. Becker Vol#: 68

EMC 93 D Gill Vol#: 68

EMC 94 H Yacoubian Vol#: 68

EMC 95 J Harper Vol#: 68

EMC 96 L Blanchard Vol#: 68

EMC 97 Tapster Vol#: 68

EMC 98 E Berman Vol#: 68

EMC 99 K Danaher Vol#: 68

EMC 100 T Anderson Vol#: 68

EMC 101 N. Roaninn Vol#: 68

EMC 102 J Mathews Vol#: 68

EMC 103 C Kaminsky Vol#: 68

EMC 104 S Raynor Vol#: 68

EMC 105 M Moore Vol#: 68

EMC 106 S Hickey Vol#: 68

EMC 107 J Wells Vol#: 68

EMC 108 A Rahmim, MD Vol#: 68

EMC 109 Vicki Vol#: 68

EMC 110 A Kruk Vol#: 68

EMC 111 S. Kaufman, M.D. Vol#: 68

EMC 112 E Johnson Vol#: 68

EMC 113 P Moss Vol#: 68

EMC 114 G Bishop Vol#: 68

EMC 115 D Read Vol#: 68

EMC 116 J Dudley Vol#: 68

EMC 117 IAC Vol#: 68

EMC 118 R Matteson Vol#: 68

EMC 119 D Ravenscroft Vol#: 68

EMC 120 W Lochner Vol#: 68

EMC 121 S Tsang Vol#: 68

EMC 122 B Robinson Vol#: 68

EMC 123 E. Glixman Vol#: 68

EMC 124 C Morrissey Vol#: 68

EMC 125 M Poma Vol#: 68

EMC 126 T Johnson Vol#: 68

EMC 127 W. Payne Vol#: 68

EMC 128 R. Cariglia Vol#: 68

EMC 129 M Adams Vol#: 68

EMC 130 R Sikora Vol#: 68

EMC 131 A Timan Vol#: 68

EMC 132 M. Orvis Vol#: 68

EMC 133 C Porter Vol#: 68

EMC 134 L Parker-Rollins Vol#: 68

EMC 135 J Sherin Vol#: 68

EMC 136 C Jewhurst Vol#: 68

EMC 137 R Anderlik Vol#: 68

EMC 138 A McGarry et al Vol#: 68

98P-0623 Revoke determination that TSRH Pedicle Spinal Screw System

REF 2 Documentation Required for Preamendment Vol#: 1

99N-1168 Public Health Impact of Foodborne Listeria Monocytogenes

EMC 1 D Ortman Vol#: 1

99P-1340 Declared Eternity eau de Parfum Misbranded

EMC 192 C Woessner Vol#: 16

00D-0186 M4 Common Technical Document;InterNatl Confern on Harmonisat

C 11 PhRMA Vol#: 2

C 12 Boehringer Ingelheim Pharmaceuticals Inc Vol#: 2

00D-1350 Combined Oral Contraceptives/Labeling/Healthcare Providers

C 12 PhRMA Vol#: 1

00D-1384 Physical Examination of Surgeons' &/or Patient Exam Gloves

C 5 Indonesian latex Gloves Industries Assn Vol#: 1

C 6 A Lowery Vol#: 1

C 7 Alliance Rubber Products Sdn. Bhd. Vol#: 1

00D-1392 Guidance for Industry on Botanical Drug Products

C 20 The Reveg Edge Vol#: 2

C 21 Ohlone Products Vol#: 20

00D-1418 Q7A ICH Good Manufacturing Practice Guide for Active Pharmac

C 7 Jerussi Consulting Inc Vol#: 1

00D-1455 Premarket Notification for Totally Implanted Spinal Cord

ANS 1 HFS to L Switzer Vol#: 1

C 1 Johns Hopkins Medicine Vol#: 1

C 2 T Rowe Price Associates Inc Vol#: 1

C 3 Comprehensive Pain & Rehabilitation Vol#: 1

C 4 U of PA Health System Vol#: 1

C 5 The Physicians' Vol#: 1

C 6 Electrovest Inc Vol#: 1

C 7 Headache & Pain Institute Vol#: 1

C 8 Neurosurgery Services Vol#: 1

C 9 ANS Inc Vol#: 1

C 10 ANS Inc Vol#: 1

C 11 C Marie Vol#: 1

C 12 G Racz MD & others Vol#: 1

C 13 Alabma Pain Center Vol#: 1

C 14 Henry Fory Hospital & Medical Centers Vol#: 1

C 15 Chandler Medical Center Vol#: 1

C 16 Stanley D Harpstead Vol#: 1

C 17 Consultants in Pain Medicine (CPM) Vol#: 1

C 18 Center for Pain Management Vol#: 1

C 19 Neurosurgical Specialties of NEPA Inc Vol#: 1

C 20 Hale and Dorr/on behalf of Medtronic Vol#: 2

MM 1 Medtronic Vol#: 1

MM 2 Meeting Minutes Vol#: 1

00D-1497 Mammography Quality Standards Act; Final Regs Document #4

C 5 Boulder Community Hospital Vol#: 1

00M-1583 PMA Vibrant P Soundbridge System; Vibrant D Soundbridge Sys

AAV 1 Symphonix Devices Inc Vol#: 1

00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair

C 28 Regeneration Technologies Inc Vol#: 2

C 29 Regeneration Technologies Inc Vol#: 2

00N-1460 Salmonella Enteritidis Research Public Meeting

C 1 CSPI Vol#: 1

C 2 CA Department of Food & Agriculture Vol#: 1

C 3 Dr H McCandless Vol#: 1

EMC 2 People for the Ethical Treatment of Anim Vol#: 1

EMC 3 United Poultry Concerns Vol#: 1

LST 1 Agenda for September 8, 2000 meeting Vol#: 1

REF 1 President's council on Food Safety Vol#: 1

TR 1 Transcript of September 8, 2000 meeting Vol#: 2

TS 1 Southeast Poultry Research Lab Vol#: 1

TS 2 USDA ARS Southeast Poultry Research Lab Vol#: 1

TS 3 Ohio State University Vol#: 1

TS 4 Georgia Poultry Laboratory Vol#: 1

TS 5 USDA ARS Southeast Poultry Research Lab Vol#: 1

TS 6 USDA ARS Southeast Poultry Research Lab Vol#: 1

TS 7 U S Poultry & Egg Association Vol#: 1

TS 8 University of California, Davis Vol#: 1

TS 9 OPHS-FSIS-USDA Vol#: 1
 

00P-0788 Totally Implanted Spinal Cord Stimulator

ANS 1 HFS-206 to L Switzer Vol#: 4

C 3 T Rowe Price Assn Inc Vol#: 4

C 4 Comprehensive Pain & Rehabilation Vol#: 4

C 5 The Physicians' Vol#: 4

C 6 University of PA Health System Vol#: 4

C 7 MUSC Neurosurgery Services Vol#: 4

C 8 Headache & Pain Institute Vol#: 4

C 9 Johns Hopkins/Pain Medicine Vol#: 4

C 10 Advanced Neuromodulation Systems Inc Vol#: 4

C 11 Advanced Neuromodulation Systems Inc Vol#: 4

C 12 C Marie Vol#: 4

C 13 TX Tech U Health Sciences Center Vol#: 4

C 14 Henry Ford Health Medical Centers Vol#: 4

C 15 Alabama Pain Center Vol#: 4

C 16 Chandler Medical Center Vol#: 4

C 17 S Harpstead Vol#: 4

C 18 Consultants In Pain Medicine Vol#: 4

C 19 Center for Pain Management Vol#: 4

C 20 Neurosurgical Specialties of NEPA Inc Vol#: 4

C 21 Hale and Dorr/on behalf of Medtronic Vol#: 5

MM 1 Medtronic Vol#: 4

MM 2 Meeting Minutes Vol#: 4

00P-1210 Restrict Sale of Coal Tar-Containing Products

C 6 Neutrogena Corporation Vol#: 1

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

C 6924 D McCargo Vol#: 301

C 6925 J Randazzo Vol#: 301

C 6926 J Maltby Vol#: 301

C 6927 R White Vol#: 301

C 6928 R Olson Vol#: 301

C 6929 N Smith Vol#: 301

C 6930 E D Forman Vol#: 301

C 6931 G Romano Vol#: 301

C 6932 M Parks Vol#: 301

C 6933 C Mitchell Vol#: 301

C 6934 K M Souza Vol#: 301

C 6935 M Olson Vol#: 301

C 6936 C Davis Vol#: 301

C 6937 A Lindou Vol#: 301

C 6938 M Seweraty Vol#: 301

C 6939 E Thorsen Vol#: 301

C 6940 D Blain Vol#: 301

C 6941 F Turley Vol#: 301

C 6942 C Blackwolf Vol#: 301

C 6943 M Ashe Vol#: 301

C 6944 A Baez Vol#: 301

C 6945 D Hinslea Vol#: 301

C 6946 T Moskowitz Vol#: 301

C 6947 D Eccher Vol#: 301

C 6948 M Sweeny Vol#: 301

C 6949 B Selis Vol#: 301

C 6950 M Sluchan Vol#: 301

C 6951 B Eleftheriou Vol#: 301

C 6952 G L LeBlanc Vol#: 301

C 6953 V Brown Vol#: 301

C 6954 L McKenna Vol#: 301

C 6955 D Sullivan Vol#: 301

C 6956 F Smith Vol#: 301

C 6957 E Voss Vol#: 301

C 6958 J Fitzgerald Vol#: 301

C 6959 M Gunther Vol#: 301

C 6960 P McClusky Vol#: 301

C 6961 L King Vol#: 301

C 6962 C Gopalakrishnan Vol#: 301

C 6963 K Carney Vol#: 301

C 6964 N Fegley Vol#: 301

C 6965 B Antovik Vol#: 301

C 6966 D Carpenter Vol#: 301

C 6967 M Waterstreet Vol#: 301

C 6968 D Cavanagh Vol#: 301

C 6969 A Shore Vol#: 301

C 6970 J Pikul Vol#: 301

C 6971 L Ledwidge Vol#: 301

C 6972 G Briseno Vol#: 301

C 6973 T Gero Vol#: 301

C 6974 S Berg Vol#: 301

C 6975 Roubira Vol#: 301

C 6976 H Dana Vol#: 301

C 6977 L Robinson Vol#: 301

C 6978 G Domerque Vol#: 301

C 6979 R Hiller Vol#: 301

C 6980 K Franks Vol#: 301

C 6981 J Paddock Vol#: 301

C 6982 C Rivers Vol#: 301

C 6983 M Paritz DC Vol#: 301

C 6984 S Hammond Vol#: 301

C 6985 S Thomas Vol#: 301

C 6986 C Tashian Vol#: 301

C 6987 M Greenberg Vol#: 301

C 6988 D Moore Vol#: 301

C 6989 S Knight Vol#: 301

C 6990 N Kroon Vol#: 301

C 6991 C Bell Vol#: 301

C 6992 G Goldston Vol#: 301

C 6993 K Wilkins Vol#: 301

C 6994 K Neeley Vol#: 301

C 6995 S Sivadas Vol#: 301

C 6996 M Rose Vol#: 301

C 6997 J Zeunert Vol#: 301

C 6998 J Smith Vol#: 301

C 6999 J Smith Vol#: 301

C 7000 L Bartosik Vol#: 301

C 7001 D Copeland Vol#: 301

C 7002 C Clement Vol#: 301

C 7003 H Bachrach Vol#: 301

C 7004 H Davis Vol#: 301

C 7005 K Davidson Vol#: 301

C 7006 R Goepfert Vol#: 301

C 7007 L Mudry Vol#: 301

C 7008 C Tracy Vol#: 301

C 7009 R Cook Vol#: 301

C 7010 C Taylor Vol#: 301

00P-1263 Initiation of Procedure to Determine Whether DHEA is exclude

LET 1 HFD-1 to Genelabs Technologies Inc Vol#: 1