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] 

DOCKETS ENTERED on December 15, 1999

Table of Contents

(Hyper links are part of the Docket  title - not all dockets/documents are linked)

[FDA DOCKETS PAGE][FDA HOME PAGE]

 
97N-484S Human Cellular and Tissue-Based Products *
99D-0557 Use of Nonhuman Primate Xenografts in Humans *
99D-4488 Reducing microbial food safety hazards for sprouted seeds *
99P-4613 Revoke the Regulation That Approved Posilac *

88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE

NFR 2 Vol#: 3

92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992

NFR 1 Vol#: 3

94F-0455 Safe Use of X-radiation To Inspect Food Cargo

EA 1 Environmental Assessment Vol#: 1

FONS1 Finding of No Significant Impact Vol#: 1

NFR 1 Vol#: 1

97N-484S Human Cellular and Tissue-Based Products

C 69 Long Island Neurosurgical Assoc Vol#: 7

C 70 Orthopaedic Assoc Vol#: 7

C 71 Colorado Neurological Ins Vol#: 7

98D-0514 Industry on ANDA's: Impurities in Drug Substances

GDL 2 Guidance Vol#: 1

NAD 2 Vol#: 1

98H-1202 Civil Money Penalties; Lake Sammamish Mini Mart Inc & Bruce

CS 3 HFA-305 Vol#: 1

OR 3 HF-3 Vol#: 1

99D-0557 Use of Nonhuman Primate Xenografts in Humans

C 340 Cynthia A Pendergrass Vol#: 49

C 341 M Gino Brogdon Jr Vol#: 49

99D-4488 Reducing microbial food safety hazards for sprouted seeds

THESE LINKED COMMENTS DUPLICATE THOSE FOR 99D-4489, ALSO BELOW

C 17 David C Wagner Vol#: 2

C 18 E James Arking PhD Vol#: 2

C 19 Jonathan's Organic Vol#: 2

C 20 Daisey Machinery Co LTD Vol#: 2

C 21 Clifford Lawrence Vol#: 2

C 22 Brek Renzelman Vol#: 2

C 23 Tom Damoth Vol#: 2

C 24 Vermont Sprout House Vol#: 2

C 25 Caudill Seed Co Inc Vol#: 2

C 26 Sun Sprout of Lancaster County Vol#: 2

C 27 Sun Sprout Enterprises Inc Vol#: 2

C 28 Louie Foods Vol#: 2

C 29 ISS LLC (International Specialty Supply) Vol#: 2

C 30 API Amalgamated Produce Inc Vol#: 2

C 31 Donald L Daniel PhD Vol#: 2

C 32 Ann Lynn Gillian PhD Vol#: 2

C 33 Ken Kimes Vol#: 2

C 34 Molecular Circuitry Inc Vol#: 2

C 35 Jacquelyn K Griffith Vol#: 2

C 36 Sunrise Farms Inc Vol#: 2

C 37 Marilyn Garreth Vol#: 2

C 38 Bonita Hurd Vol#: 2

C 39 June Magnald Vol#: 2

C 40 June Magnald Vol#: 2

EMC 1 Valerie Quinlan Vol#: 2

99D-4489 Sampling & microbial testing of spent irrigation water

C 17 David C Wagner Vol#: 2

C 18 E James Arking PhD Vol#: 2

C 19 Jonathan's Organic Vol#: 2

C 20 Daisey Machinery Co LTD Vol#: 2

C 21 Clifford Lawrence Vol#: 2

C 22 Brek Renzelman Vol#: 2

C 23 Tom Damoth Vol#: 2

C 24 Vermont Sprout House Vol#: 2

C 25 Caudill Seed Co Inc Vol#: 2

C 26 Sun Sprout of Lancaster County Vol#: 2

C 27 Sun Sprout Enterprises Inc Vol#: 2

C 28 Louie Foods Vol#: 2

C 29 ISS LLC (International Specialty Supply) Vol#: 2

C 30 API Amalgamated Produce Inc Vol#: 2

C 31 Donald L Daniel PhD Vol#: 2

C 32 Ann Lynn Gillian PhD Vol#: 2

C 33 Ken Kimes Vol#: 2

C 34 Molecular Circuitry Inc Vol#: 2

C 35 Jacquelyn K Griffith Vol#: 2

C 36 Sunrise Farms Inc Vol#: 2

C 37 Marilyn Garreth Vol#: 2

C 38 Bonita Hurd Vol#: 2

C 39 June Magnald Vol#: 2

C 40 June Magnald Vol#: 2

EMC 1 Valerie Quinlan Vol#: 2

99H-4879 Civil Money Penalty;4-Way Quick Stop Inc,dba 4-Way Quick Sto

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4880 Civil Money Penalty;7-Eleven Inc,7-Eleven #21344

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4881 Civil Money Penalty;Bar None II Corp,dba Bar None II

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4882 Civil Money Penalty;Bayview Pharmacy Inc,dba Bayview Pharmac

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4883 Civil Money Penalty;Meseret Bekele,dba Foggy Bottom Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4884 Civil Money Penalty;Clark Gas & Oil Company Inc,dba E-Z Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4885 Civil Money Penalty;Esmeraldo Diogo,dba Reis Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4886 Civil Money Penalty;Dyer Foods Inc,dba Food Rite #22

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4887 Civil Money Penalty;Eckerd Corporation,dba Eckerd Drug #8240

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4888 Civil Money Penalty;William Leon Glenn and Larry Glenn

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4889 Civil Money Penalty;High's of Baltimore Incorporated,dba Hig

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99N-0407 Reclassification Petitions for Medical Devices

N 2 Vol#: 1

99N-2553 Agency Collection Activities; Citizen Petition

N 2 Vol#: 1

99N-4957 Removal of Designed Journals Companion Document

NFR 1 Vol#: 1

NPR 1 Vol#: 1

99P-4613 Revoke the Regulation That Approved Posilac

EMC 66 Joe Bateman Vol#: 1

EMC 67 Evelyn Bergaila Vol#: 1

EMC 68 Nan Taska Vol#: 1

EMC 69 David A McInnis Vol#: 1

EMC 70 Pamela Thebault Vol#: 1

EMC 71 Janice Larson Vol#: 1

EMC 72 Mark Snyder Vol#: 1

EMC 73 Roban Bieber Vol#: 1

EMC 74 Crystal Vol#: 1

EMC 75 Swami Vol#: 1

EMC 76 Rebecca Hobson Vol#: 2

EMC 77 Grayjay Vol#: 2

EMC 78 James E. Murphy Vol#: 2

EMC 79 Alice Vol#: 2

EMC 80 Helen K. Shulman Vol#: 2

EMC 81 Jordyn Bonds Vol#: 2

EMC 82 Ronnie Kolbs Vol#: 2

EMC 83 Shirley Ely Vol#: 2

EMC 84 Robert Oakeson Vol#: 2

EMC 85 Patsy Quillin Vol#: 2

EMC 86 Kurt Rowe Vol#: 2

EMC 87 Noel A. Taylor, MM, DC Vol#: 2

EMC 88 West Chester University of Pennsylvania Vol#: 2

EMC 89 Nancy L Krutenat Vol#: 2

EMC 90 Martin Kroeze Vol#: 2

EMC 91 Robert Day Vol#: 2

EMC 92 Helen Meader Vol#: 2

EMC 93 Patrick J. Moore Vol#: 2

EMC 94 Steve Rapalus Vol#: 2

EMC 95 Melinda Echols Vol#: 2

EMC 96 Lorraine Asturino Vol#: 2

EMC 97 Jack Tanis Vol#: 2

EMC 98 Joan P. Smith Vol#: 2

EMC 99 Jennifer Raymond Vol#: 2

EMC 100 Concerned U.S. Citizen Vol#: 2

EMC 101 Ruth Morita Vol#: 2

EMC 102 Elliot Feldman Vol#: 2

EMC 103 David Levin Vol#: 2

EMC 104 Jeff and Nancy Riedesel Vol#: 2

EMC 105 GIAN CLAUDIO GUIDUCCI Vol#: 2

EMC 106 Gina Mitchell Vol#: 2

EMC 107 Erica Kasprzyk Vol#: 2

EMC 108 Momentum World Wire Vol#: 2

EMC 109 Elinda McKenna Vol#: 2

EMC 110 Stephanie Vol#: 2

EMC 111 Brian Jennings Vol#: 2

EMC 112 Jeff Dames Vol#: 2

EMC 113 Karilyn van Soest Vol#: 2

EMC 114 Linda Piel Vol#: 2

EMC 115 andre'Cholmondeley Vol#: 2

EMC 116 Raoul Pop Vol#: 2

EMC 117 Terri Cosgriff Vol#: 2

EMC 118 Don Cox Vol#: 2

EMC 119 Michael Janson, M.D. Vol#: 2

EMC 120 Beth Grote Vol#: 2

EMC 121 Alona Katz Vol#: 2

EMC 122 CTG Distribution Sales Vol#: 2

EMC 123 Eric Fricker Vol#: 2

EMC 124 Niles Meltesen Vol#: 2

EMC 125 University of Minnesota, Women's Athlets Vol#: 2

EMC 126 Karla Starkenberg Vol#: 2

EMC 127 Marcia E. Herman-Giddens, PA, DrPH Vol#: 2

EMC 128 M. Gasior Vol#: 2

EMC 129 J Marvin Lange Vol#: 2

EMC 130 Terri Fann Vol#: 2

EMC 131 Steve Rodgers Vol#: 2

EMC 132 Bob Kessler Vol#: 2

EMC 133 Dave and Phyllis Johnson Vol#: 2

EMC 134 Becky Swalberg Vol#: 2

EMC 135 Adam S. Levy Vol#: 2

EMC 136 Carolyn Martin Vol#: 2

EMC 137 Kimberle Ganzer Vol#: 2

EMC 138 Cindy Cole Vol#: 2

EMC 139 Andrea Lieberman Vol#: 2

EMC 140 Michael R. Thune Vol#: 2

EMC 141 Cheryl Rounds Vol#: 2

EMC 142 atom Vol#: 2

EMC 143 Beverly McManus Vol#: 2

EMC 144 Jon Brunn Vol#: 2

EMC 145 Cynthia Mantel Vol#: 2

EMC 146 Kurt S. Hirsch Vol#: 2

EMC 147 Thomas Frye Vol#: 2

EMC 148 Richard Cicchetti Vol#: 2

EMC 149 Tracy Riley Vol#: 2

EMC 150 Dale Henry Vol#: 2

EMC 151 Christine Maggiore Vol#: 2

EMC 152 Mark Jacobsen Vol#: 2

EMC 153 Jimmy Palmer Vol#: 2

EMC 154 Cynthia Mantel Vol#: 2

EMC 155 Charlotte Mulder Vol#: 2

EMC 156 Dan Gookin RPh.r Vol#: 2

EMC 157 R.Casey, M.D. Vol#: 2

EMC 158 Vonnie Hanford Vol#: 2

EMC 159 Dave Reiss Vol#: 2

EMC 160 Candy Brooks Vol#: 2

EMC 161 Bill Boehmer Vol#: 2

EMC 162 Lowell "Aman" Cable Vol#: 2

EMC 163 Dr. Kerrie Saunders Vol#: 2

EMC 164 Janis Lindenberger Vol#: 2

EMC 165 John Allon Vol#: 2

EMC 166 Anthony Hughes Vol#: 2

EMC 167 Elizabeth J. Robinson Vol#: 2

EMC 168 Susan Best Vol#: 2

EMC 169 Dali Vol#: 2

EMC 170 Dorothy Wells Vol#: 2

EMC 171 Wendy S. Row Vol#: 2

EMC 172 Nanette Grace Taska Vol#: 2

EMC 173 Don Johnson Vol#: 2

EMC 174 Daniel Stehura Vol#: 2

EMC 175 LAURYN GARZA Vol#: 2

EMC 176 TOM ATTWOOD Vol#: 3

EMC 177 Maureen stacy Vol#: 3

EMC 178 Shirley Crosby Vol#: 3

EMC 179 Sara Motley Vol#: 3

EMC 180 Eric Straatsma Vol#: 3

EMC 181 Dean Durant Vol#: 3

EMC 182 Donna Watkins Vol#: 3

EMC 183 Jamglo Vol#: 3

EMC 184 Agentcat Vol#: 3

EMC 185 Kathy Parent Vol#: 3

EMC 186 Corinne Vol#: 3

EMC 187 Joyce L Weller Vol#: 3

EMC 188 Steve Nepi Vol#: 3

EMC 189 Lianne Lang Vol#: 3

EMC 190 Joytail Vol#: 3

EMC 191 Mona Yardumian Vol#: 3

EMC 192 Mental Orbit Vol#: 3

EMC 193 Mike Polzint Vol#: 3

EMC 194 CinnoWorld Vol#: 3

EMC 195 Nancy O. Richards Vol#: 3

EMC 196 Paul Grignon Vol#: 3