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 November 9, 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 *
98P-0145 Requirements for demonstrating In Vivo Bioequivalence *
99N-3089 Draft Affirmative Agenda for International Activities *
99P-4870 ANDA for Sterile Cefazolin Sodium, USP *
99P-4871 ANDA for Sterile Cefuroxime Sodium, USP *
97N-484S Human Cellular and Tissue-Based Products

C 2 Walter Mitchell Vol#: 6

C 3 Sander S Shapiro MD Vol#: 6

C 4 James A Grifo MD PhD Vol#: 6

C 5 Jim Toner MD PhD Vol#: 6

98P-0145 Requirements for demonstrating In Vivo Bioequivalence

PRC 1 Andrx Pharmaceuticals, Inc. Vol#: 6

99H-1448 Civil Money Penalties;Donald German,d/b/a The Alibi

CS 3 HFA-305 Vol#: 1

OR 2 HF-3 Vol#: 1

99H-4177 Civil Money Penalty:Interstate Foods Inc dba the Curb Store

ANS 1 Interstate Foods Inc Vol#: 1

99H-4249 Civil Money Penalty;Maverik Country Stores Inc,dba Maverik

ANS 1 Maverik Country Store #273 Vol#: 1

99H-4398 Civil Money Penalty;Merit Oil Corp,dba Merit Gas Station

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4523 Civil Money Penalty;Auto Service & Supply Co Inc,dba West Te

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4524 Civil Money Penalty;Buco Liquors Inc,dba Buco Liquors

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4525 Civil Money Penalty;Cumberland Farms Inc,dba Cumberland Farm

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4526 Civil Money Penalty;Doris' Market Inc,dba Doris' Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4527 Civil Money Penalty;E-Z Mart Stores Inc,dba E Z Mart Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4528 Civil Money Penalty;Happy Harry's Inc,dba Harry Harry's Inc

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4529 Civil Money Penalty;Thu Le,dba J & J Discount Mini Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4530 Civil Money Penalty;Guilermo Nalo,dba Casa Victoria

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4531 Civil Money Penalty;Toufic E Raad,dba Rockdale Getty

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4532 Civil Money Penalty;Shore Stop Corp,dba Shore Stop Express

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4533 Civil Money Penalty;Break Pointe Stores Inc,dba Break Point

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4534 Civil Money Penalty;C & S 2000 Corporation,dba First Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4535 Civil Money Penalty;Gilson's Minit Mart Inc,dba Gilson Minit

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4536 Civil Money Penalty;Jenny Kollasch & Steve Kollasch,dba Banc

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4537 Civil Money Penalty;Morris Marketers Inc,dba Shell Food Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4538 Civil Money Penalty;Multicorp Management Group Inc,dba Shell

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4539

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4540 Civil Money Penalty;Pat's Super Market Inc,dba Pat's Foods

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4541 Civil Money Penalty;Tedeschi Food Shops Inc,dba Li'L Peach

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4542 Civil Money Penalty;Wawa Inc,dba Wawa Food Market #830

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99N-3089 Draft Affirmative Agenda for International Activities

C 6 National Fisheries Institute Vol#: 1

C 7 Center for Science in the Public Interes Vol#: 1

LET 1 Center for Science in the Public Interes Vol#: 1

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

EMC 82 Irene Bensinger Vol#: 1

EMC 83 Julia A Harris Vol#: 1

EMC 84 Leanne T Goodsell Vol#: 1

EMC 85 Kathleen B Pursifull Vol#: 1

EMC 86 Robin Allen-Paris Vol#: 1

EMC 87 Sabrina Johnston Vol#: 1

EMC 88 Jean-Francois P Trahan Vol#: 1

EMC 89 Taylor R Felker Vol#: 1

EMC 90 Cindy Hauserman Vol#: 1

EMC 91 Elizabeth T Brown Vol#: 1

EMC 92 Laura D Todd Vol#: 1

EMC 93 Bobbie D Flowers Vol#: 1

EMC 94 Richard W Layman Vol#: 1

EMC 95 Kathleen E Dolphin Vol#: 1

EMC 96 Angela M Priest Vol#: 1

EMC 97 Erik A Farseth Vol#: 1

EMC 98 Jill Gambino Vol#: 1

EMC 99 Kris Morahn Vol#: 1

EMC 100 Kristie L Mobley Vol#: 1

EMC 101 Molly B Campbell Vol#: 1

EMC 102 Kyle A Slesicki Vol#: 1

EMC 103 Tanya Tiedje Vol#: 1

EMC 104 Irene Mills Vol#: 1

EMC 105 James E Holdman Vol#: 1

EMC 106 Bonnie Shay Vol#:

EMC 107 Debbie Ortman Vol#: 1

EMC 108 Heidi MacKay Vol#: 1

EMC 109 Susan C Ferry Vol#: 1

EMC 110 David Powelson Vol#: 1

EMC 111 Daniel J Highkin MD Vol#: 1

EMC 112 Form letter count 170 Vol#: 2

EMC 113 Kathy Moffat Vol#: 1

EMC 114 Mary Elsia Wu Vol#: 1

EMC 115 Dana B Randell Vol#: 1

EMC 116 Carolyn Banks Vol#: 1

EMC 117 Jeffrey Kirk Vol#: 1

EMC 118 Clifford Ginn Vol#: 1

EMC 119 Michele N Styer Vol#: 1

EMC 120 Lauretta Lange Vol#: 1

EMC 121 Leda A G Huta Vol#: 1

EMC 122 Gregory E Albertson Vol#: 1

EMC 123 Sarah Sockit Vol#: 1

EMC 124 Nancy E Lawler Vol#: 1

EMC 125 Lynn R Rossiter Vol#: 1

EMC 126 David T Fryer Vol#: 1

EMC 127 Taran D Singleton Vol#: 1

EMC 128 Karen M Ellis Vol#: 1

EMC 129 Jean-Paul Ladner Jr Vol#: 1

EMC 130 Michael S Gardner Vol#: 1

EMC 131 Judith A Detert-Moriarty Vol#: 1

EMC 132 Donald F Grbac Vol#: 1

EMC 133 Judith E Stevens Vol#: 1

EMC 134 Corby Harper Vol#: 1

EMC 135 Desiree I Cole Vol#: 1

EMC 136 Ryan N Weemhoff Vol#: 1

EMC 137 S Christopher Jacobs Vol#: 1

EMC 138 Olivia K McIntosh Vol#: 1

EMC 139 Melanie N St James Vol#: 1

EMC 140 Nancy B Spears Vol#: 1

EMC 141 Loretta E Dunne Vol#: 1

EMC 142 Jeffrey M Thompson Vol#: 1

EMC 143 Joan Ambo Vol#: 1

EMC 144 Caleb M Rollo Vol#: 1

EMC 145 Simona Vogel Vol#: 1

EMC 146 Alfred S Fuller Vol#: 1

EMC 147 Ann Chen Vol#: 1

EMC 148 Melissa A Gilham Vol#: 3

EMC 149 Rob Dickerson Vol#: 3

EMC 150 David W Koenig Vol#: 3

EMC 151 Farrah R McKenzie Vol#: 3

EMC 152 Elizabeth Anders Vol#: 3

EMC 153 Kim J Gant Vol#: 3

EMC 154 Mark A Moran Vol#: 3

EMC 155 Alison J Luedecke Vol#: 3

EMC 156 Carole Connet Vol#: 3

EMC 157 Frederik E Jente Vol#: 3

EMC 158 Katherine Hamil Vol#: 3

EMC 159 Form letter count 26 Vol#: 4

EMC 160 Carol A Allee Vol#: 3

EMC 161 Jane A Jensen Vol#: 3

EMC 162 Megan A Robbins Vol#: 3

EMC 163 Jon H Widhmann Vol#: 3

EMC 164 Keren Kaufman Vol#: 3

EMC 165 Bob Rozett Vol#: 3

EMC 166 Dennis Adsit PhD Vol#: 3

EMC 167 Jane Winn Vol#: 3

EMC 168 Linda Bystrak Vol#: 3

EMC 169 Grace Erhart Vol#: 3

EMC 170 David Saunders Vol#: 3

EMC 171 Jerome Mc Collom Vol#: 3

EMC 172 Yvonne Duprez Vol#: 3

EMC 173 Ramon Puga Vol#: 3

EMC 174 Andrew Butz Vol#: 3

EMC 175 Thomas Aquilla Vol#: 3

EMC 176 Patricia A Bosi Vol#: 3

EMC 177 Mano Vol#: 3

EMC 178 Kristen M Tuinstra Vol#: 3

EMC 179 Lynne Mason Vol#: 3

EMC 180 Jason D Schnarr Vol#: 3

EMC 181 Michele Delehanty Vol#: 3

EMC 182 Salma J Shamy Vol#: 3

EMC 183 Carolyn P Higgins Vol#: 3

EMC 184 Roberto O Lozano Vol#: 3

EMC 185 Eric Obleman Vol#: 3

EMC 186 Anna Walters Vol#: 3

EMC 187 Leigh B Brooks Vol#: 3

EMC 188 William J Greene Vol#: 3

EMC 189 Jennifer K Elrod Vol#: 3

EMC 190 Jeffrey A Ensminger Vol#: 3

EMC 191 Tony Kaperick Vol#: 3

EMC 192 Lakshmi K Khalsa Vol#: 3

EMC 193 Nancy A Salle Vol#: 3

EMC 194 Jason A Walker Vol#: 3

EMC 195 Chris Frantzen Vol#: 3

EMC 196 Emily D Kaufman Vol#: 3

EMC 197 Walter Muelken Vol#: 3

EMC 198 Gina L Marchini Vol#: 3

EMC 199 Scott A Woodard Vol#: 3

EMC 200 Form letter count 162 Vol#: 5

EMC 201 Dr Jonathan Matthews Vol#: 3

EMC 202 Juliann Barbatp Vol#: 3

EMC 203 Leslie Pelch Vol#: 3

EMC 204 Ann Beth Vol#: 3

EMC 205 Dr Margaret Hammitt-McDonald Vol#: 3

EMC 206 Sherry M Freeman Vol#: 3

EMC 207 Irene Bensinger Vol#: 3

EMC 208 Robin Ticciati Vol#: 3

EMC 209 Patricia Youngson Vol#: 3

EMC 210 Samuel R Horton Vol#: 3

EMC 211 Crystal L Voyles Vol#: 3

EMC 212 Christine E Lorenz Vol#: 3

EMC 213 Forrest S Beal Vol#: 3

EMC 214 Mark M Giese Vol#: 3

EMC 215 Cynthia M Weiss Vol#: 3

EMC 216 Duncan Macomber Vol#: 3

EMC 217 L Gilmartin Vol#: 3

EMC 218 Pamela E Forsyth Vol#: 3

EMC 219 John M Gear Vol#: 3

EMC 220 David Klein Vol#: 3

EMC 221 Darlene A Behnke Vol#: 3

EMC 222 Marta D Moskowitz Vol#: 3

EMC 223 Tony Kaperick Vol#: 3

EMC 224 John L Noyes MD Vol#: 3

EMC 225 Yuri I Huta Vol#: 3

EMC 226 Roland Shafer Vol#: 3

EMC 227 David E Turner Vol#: 3

EMC 228 Jennet Grover Vol#: 3

99P-4870 ANDA for Sterile Cefazolin Sodium, USP

THESE LINKED COMMENTS DUPLICATE THOSE IN 99P-4871, ALSO BELOW

ACK 1 HFA-305 Vol#: 1

CP 1 Quinn Consulting Services Vol#: 1

99P-4871 ANDA for Sterile Cefuroxime Sodium, USP

ACK 1 HFA-305 Vol#: 1

CP 1 Quinn Consulting Services Vol#: 1