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DOCKETS ENTERED on July 23, 2001

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97N-484P Current Good Tissue Practice for Mfrs. of Human Cellular *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00N-0074 Safeguards for Children Clinical Ivestigations FDA-Regulated *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
01D-0044 Clinical Laboratory Improvement Amendments of 1988 *
01D-0162 Using FDA-Approved Patient Labeling in Consumer-Directed *
01N-0197 Treatment of Ankylosing Spondylitis and Related Disorders *

97N-484P Current Good Tissue Practice for Mfrs. of Human Cellular

C 45 Grady Health System Vol#: 5

98N-0337 Over the counter human drugs labeling requirements

APP 18 Perrigo Company Vol#: 8

APP 19 Perrigo Company Vol#: 8

APP 20 Perrigo Company Vol#: 8

APP 21 Perrigo Company Vol#: 8

APP 22 Perrigo Company Vol#: 8

APP 23 Perrigo Company Vol#: 8

APP 24 Perrigo Company Vol#: 8

APP 25 Perrigo Company Vol#: 8

APP 26 Perrigo Company Vol#: 8

APP 27 Perrigo Company Vol#: 8

00D-1598 Voluntary Labeling for Bioengineered Foods

EMC 9078 A Daily Vol#: 368

EMC 9079 R Wheeler Vol#: 368

EMC 9080 R Wheeler Vol#: 368

EMC 9081 L Penney Vol#: 368

EMC 9082 K Reinhardt Vol#: 368

EMC 9083 S Idle Vol#: 368

EMC 9084 S Idle Vol#: 368

EMC 9085 A Obersteiner Vol#: 368

EMC 9086 B Hasselman Vol#: 368

EMC 9087 A Miller Vol#: 368

EMC 9088 M Rossa Vol#: 368

EMC 9089 L Bryan Vol#: 368

EMC 9090 L Bryan Vol#: 368

EMC 9091 unsigned Vol#: 368

EMC 9092 D Garuti Vol#: 368

EMC 9093 D Garuti Vol#: 368

EMC 9094 M Clay Vol#: 368

EMC 9095 M Clay Vol#: 368

EMC 9096 W Graff Vol#: 368

EMC 9097 unsigned Vol#: 368

EMC 9098 J Smith Vol#: 368

EMC 9099 O Need Vol#: 368

EMC 9100 B Poulin Vol#: 368

EMC 9101 S O'Keeffe Vol#: 368

EMC 9102 M Lonabaugh Vol#: 368

EMC 9103 M Engelman Vol#: 368

EMC 9104 D Janssen Vol#: 368

EMC 9105 S Urban Vol#: 368

EMC 9106 S Urban Vol#: 368

EMC 9107 M Valance Vol#: 368

EMC 9108 H White Vol#: 368

EMC 9109 S Slaughter Vol#: 368

EMC 9110 S Barison Vol#: 368

EMC 9111 J Lashua Vol#:

EMC 9112 L Moorcock Vol#: 368

EMC 9113 R Glover Vol#: 368

EMC 9114 R Glover Vol#: 368

EMC 9115 D Stoess Vol#: 368

EMC 9116 E Hutchinson Vol#: 368

EMC 9117 A Neher Vol#: 368

EMC 9118 R Remington Vol#: 368

EMC 9119 Yankee Vol#: 368

EMC 9120 K Walton Vol#: 368

EMC 9121 C Simpson Vol#: 368

EMC 9122 J Hubbard Vol#: 368

EMC 9123 E Fleming Vol#: 368

EMC 9124 L Trescott Vol#: 368

EMC 9125 V Lim Vol#: 368

EMC 9126 T Grant Vol#: 368

EMC 9127 L Fintus Vol#: 368

EMC 9128 D Victor Vol#: 368

EMC 9129 D Nesson Vol#: 368

EMC 9130 D Yeater Vol#: 368

EMC 9131 D Stripling Vol#: 368

EMC 9132 G Sandonato Vol#: 368

EMC 9133 B Dekema Vol#: 368

EMC 9134 L Epps Vol#: 368

EMC 9135 L Epps Vol#: 368

EMC 9136 W Hunt Vol#: 368

EMC 9137 E Posada Vol#: 368

EMC 9138 D Lonowski Vol#: 368

EMC 9139 Bn Crescenzo Vol#: 368

EMC 9140 A Kucera Vol#: 368

EMC 9141 A Kucera Vol#: 368

EMC 9142 S Whytal Vol#: 368

EMC 9143 S Whytal Vol#: 368

EMC 9144 S Belanger Vol#: 368

EMC 9145 C Reidemeister Vol#: 368

EMC 9146 S Fairchild Vol#: 368

EMC 9147 D Kuchlewski Vol#: 368

EMC 9148 D Kuchlewski Vol#: 368

EMC 9149 M King Vol#: 368

EMC 9150 N Nasser Vol#: 368

EMC 9151 S Hicks Vol#: 368

EMC 9152 S Hicks Vol#: 368

EMC 9153 W Tuttle Vol#: 368

EMC 9154 C Benom Vol#: 368

EMC 9155 G Larson Vol#: 368

EMC 9156 A Stahl Vol#: 368

EMC 9157 A Stahl Vol#: 368

EMC 9158 B Allen Vol#: 368

EMC 9159 E Luevano Vol#: 368

EMC 9160 E Zanetti Vol#: 368

EMC 9161 J Zanetti Vol#: 368

EMC 9162 B Chase Vol#: 368

EMC 9163 P Monahan Vol#: 368

EMC 9164 unsigned Vol#: 368

EMC 9165 unsigned Vol#: 368

EMC 9166 W Stancil Vol#: 368

EMC 9167 B Rivenes Vol#: 368

EMC 9168 C Dowe Vol#: 368

EMC 9169 C Dowe Vol#: 368

EMC 9170 H Bell Vol#: 368

EMC 9171 N Hyslop Vol#: 368

EMC 9172 D Ballou Vol#: 368

EMC 9173 M Duffy Vol#: 368

EMC 9174 R Bruce Vol#: 368

EMC 9175 R Bruce Vol#: 368

EMC 9176 P Lonero Vol#: 368

EMC 9177 S Lauder Vol#: 368

EMC 9178 S Staehli Vol#: 368

EMC 9179 V Galenas Vol#: 368

EMC 9180 S Lin Vol#: 368

EMC 9181 T Swenson Vol#: 368

EMC 9182 R Lauve Vol#: 368

EMC 9183 V Irvin Vol#: 368

EMC 9184 C Hagood Vol#: 368

EMC 9185 B Isiaka Vol#: 368

EMC 9186 C Smith Vol#: 368

EMC 9187 S Davies Vol#: 368

EMC 9188 M Risden Vol#: 368

EMC 9189 A Vlasopolos Vol#: 368

EMC 9190 J Temple Vol#: 368

EMC 9191 S Karasek Vol#: 368

EMC 9192 S Karasek Vol#: 368

EMC 9193 S Karasek Vol#: 368

EMC 9194 S Karasek Vol#: 368

EMC 9195 B Pataki Vol#: 368

EMC 9196 S Irvin Vol#: 368

EMC 9197 R Staber Vol#: 368

EMC 9198 P Falbo Vol#: 368

EMC 9199 S Carey Vol#: 368

EMC 9200 unsigned Vol#: 368

EMC 9201 T Walls Vol#: 369

EMC 9202 C Wrinn Vol#: 369

EMC 9203 J Stathakis Vol#: 369

EMC 9204 W Hirst Vol#: 369

EMC 9205 N Lopin Vol#: 369

EMC 9206 M Van Gores Vol#: 369

EMC 9207 R Archer Vol#: 369

EMC 9208 R Guillermo Vol#: 369

EMC 9209 A Rodriguez Vol#: 369

EMC 9210 C Sloat Vol#: 369

EMC 9211 R Muller Vol#: 369

EMC 9212 N Burkw Vol#: 369

EMC 9213 S Kahn Vol#: 369

EMC 9214 N Burke Vol#: 369

EMC 9215 S Ghazanfar Vol#: 369

EMC 9216 T McGovern Vol#: 369

EMC 9217 M Bacigalupi Vol#: 369

EMC 9218 K Nyland Vol#: 369

EMC 9219 J Dahlquist Vol#: 369

EMC 9220 P Bietsch Vol#: 369

EMC 9221 A Shapiro Vol#: 369

EMC 9222 G Hotham Vol#: 369

EMC 9223 C Mark Vol#: 369

EMC 9224 F Hoffmann Vol#: 369

EMC 9225 F Hoffmann Vol#: 369

EMC 9226 C Troutman Vol#: 369

EMC 9227 S Drais Vol#: 369

EMC 9228 D Ahlers Vol#: 369

EMC 9229 K Tracy Vol#: 369

EMC 9230 S Cobb Vol#: 369

EMC 9231 S Cobb Vol#: 369

EMC 9232 A Macksoud Vol#: 369

EMC 9233 M Armstrong Vol#: 369

EMC 9234 D Holtslander Vol#: 369

EMC 9235 S Strauch Vol#: 369

EMC 9236 C Mayes Vol#: 369

EMC 9237 S Strauch Vol#: 369

EMC 9238 C Paravicini Vol#: 369

EMC 9239 B Davis Vol#: 369

EMC 9240 G Ashley Vol#: 369

EMC 9241 L Babcock Vol#: 369

EMC 9242 S Zabower Vol#: 369

EMC 9243 A Lord Vol#: 369

EMC 9244 P Thomas Vol#: 369

EMC 9245 D Schwanke Vol#: 369

EMC 9246 D Peltier Vol#: 369

EMC 9247 K Ransom Vol#: 369

EMC 9248 K Huisinga Vol#: 369

EMC 9249 A Ellis Vol#: 369

EMC 9250 A Dixon Vol#: 369

EMC 9251 R Stout Vol#: 369

EMC 9252 C Vincent Vol#: 369

EMC 9253 L Rose Vol#: 369

EMC 9254 A Cohen Vol#:

EMC 9255 D Rodgers Vol#: 369

EMC 9256 N Pedersen Vol#: 369

EMC 9257 Cynthia Vol#: 369

EMC 9258 G Sajdera Vol#: 369

EMC 9259 J Kyzer Vol#: 369

EMC 9260 D Grieco Vol#: 369

EMC 9261 D Merritt Vol#: 369

EMC 9262 D Merritt Vol#: 369

EMC 9263 J Burtenshaw Vol#: 369

EMC 9264 J Burtenshaw Vol#: 369

EMC 9265 A Elterman Vol#: 369

EMC 9266 B Exline Vol#: 369

EMC 9267 B Exline Vol#: 369

EMC 9268 C Kruse Vol#: 369

EMC 9269 C Thomas Vol#: 369

EMC 9270 B Wexler Vol#: 369

EMC 9271 C Percy Vol#: 369

EMC 9272 C Percy Vol#: 369

EMC 9273 B Exline Vol#: 369

EMC 9274 J Ferrugiaro Vol#: 369

EMC 9275 R Gautier Vol#: 369

EMC 9276 B Atkins Vol#: 369

EMC 9277 B Allen Vol#: 369

EMC 9278 S Meehan Vol#: 369

EMC 9279 S Morefield Vol#: 369

EMC 9280 B Wolner Vol#: 369

EMC 9281 D Van Fleteren Vol#: 369

EMC 9282 K Allsbrook Vol#: 369

EMC 9283 K Allsbrook Vol#: 369

EMC 9284 K Teplik Vol#: 369

EMC 9285 unsigned Vol#: 369

EMC 9286 S Massey Vol#: 369

EMC 9287 D Duke Vol#: 369

EMC 9288 D Stewart Vol#: 369

EMC 9289 L Pratt Vol#: 369

EMC 9290 L Forster Vol#: 369

EMC 9291 L Forster Vol#: 369

EMC 9292 R Jackson Vol#: 369

EMC 9293 B Sheets Vol#: 369

EMC 9294 E Hilliard Vol#: 369

EMC 9295 E Hilliard Vol#: 369

EMC 9296 M Bichell Vol#: 369

EMC 9297 M Ebron Vol#: 369

EMC 9298 A Martin Vol#: 369

EMC 9299 M O'Connor Vol#: 369

00N-0074 Safeguards for Children Clinical Ivestigations FDA-Regulated

C 6 Merck & Co., Inc. Vol#: 1

C 7 Genzyme Corp. Vol#: 1

C 8 U.S. Dept. of Health & Human Services Vol#: 1

C 9 COGR, Council On Governmental Relations Vol#: 1

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 6616 M DiNunzio Vol#: 249

C 6617 J Toby Vol#: 249

C 6618 I VanOffelen Vol#: 249

C 6619 C Willox Vol#: 249

C 6620 I VanOffelen Vol#: 249

C 6621 L Rowan Vol#: 249

C 6622 S Jones Vol#: 249

C 6623 K O"Connor Vol#: 249

C 6624 E Strom Vol#: 249

C 6625 B Grand Vol#: 249

C 6626 F Buckner Vol#: 249

C 6627 L Fair Vol#: 249

C 6628 J Gluck Vol#: 249

C 6629 S Condes Vol#: 249

C 6630 G Smith Vol#: 249

C 6631 E Valeri Vol#: 249

C 6632 Loew Vol#: 249

C 6633 A Leavitt Vol#: 249

C 6634 T Leahy Vol#: 249

C 6635 S Guinee Vol#: 249

C 6636 A Dunas Vol#: 249

C 6637 B Wise Vol#: 249

C 6638 T Yntena Vol#: 249

C 6639 H Foster Vol#: 249

C 6640 S Carley Vol#: 249

C 6641 A Johnson Vol#: 249

C 6642 A Patrick Vol#: 249

C 6643 K Ott Vol#: 249

C 6644 L Lobel Vol#: 249

C 6645 P Plesh Vol#: 249

C 6646 A Dostourian Vol#: 249

C 6647 N Bender Vol#: 249

C 6648 R Lever Vol#: 249

C 6649 M Fortese Vol#: 249

C 6650 M Bauer Vol#: 249

C 6651 S Mays Vol#: 249

C 6652 G Weber Vol#: 249

C 6653 J Holland Vol#: 249

C 6654 S Bookant Vol#: 249

C 6655 C Maio Vol#: 249

C 6656 K Riley Vol#: 249

C 6657 K Taylor Vol#: 249

C 6658 J Reidy Vol#: 249

C 6659 I Foster Vol#: 249

C 6660 E Milman Vol#: 249

C 6661 D Gould Vol#: 249

C 6662 L Daudt Vol#: 249

C 6663 L Honzik Vol#: 249

C 6664 P Dennstedt Vol#: 249

C 6665 C Cummings Vol#: 249

C 6666 G Fitzwater Vol#: 249

C 6667 L Lucafo Vol#: 249

C 6668 L Vanderberg Vol#: 249

C 6669 N Yamin Vol#: 249

C 6670 L Smith Vol#: 249

C 6671 D Genevieve Vol#: 249

C 6672 C Davis Vol#: 249

C 6673 J Lovasich Vol#: 249

C 6674 C Schutz Vol#: 249

C 6675 unreadable Vol#: 249

C 6676 J Rosen Vol#: 249

C 6677 P Evans Vol#: 249

C 6678 unreadable Vol#: 249

C 6679 P Diers Vol#: 249

C 6680 M Perry Vol#: 249

C 6681 P Beis Vol#: 249

C 6682 D Giffels Vol#: 249

C 6683 B Cohen Vol#: 249

C 6684 R Schuler Vol#: 249

C 6685 C Thompson Vol#: 249

C 6686 R Bolton Vol#: 249

C 6687 B Braudler Vol#: 249

C 6688 N Wyeth Vol#: 249

C 6689 S Miller Vol#: 249

C 6690 B Oliver Vol#: 249

C 6691 K Niachado Vol#: 249

C 6692 G Moya Vol#: 249

C 6693 K Pierce Vol#: 249

C 6694 unreadable Vol#: 249

C 6695 M Shevin Vol#: 249

C 6696 F McMahon Vol#: 249

C 6697 T Mora Vol#: 249

C 6698 D Polsky Vol#: 249

C 6699 S Zick Vol#: 249

C 6700 I Plesko Vol#: 249

C 6701 M Matheny Vol#: 249

C 6702 S Davidson Vol#: 249

C 6703 M Turner Vol#: 249

C 6704 D Hansmann Vol#: 249

C 6705 R Skarbonkiewitz Vol#: 249

C 6706 B Kaplan Vol#: 249

C 6707 A Long Vol#: 249

C 6708 B Gallagher Vol#: 249

C 6709 R Squillack Vol#: 249

C 6710 V Santarelle Vol#: 249

C 6711 K Kerney Vol#: 249

C 6712 J McMatton Vol#: 249

C 6713 B Oliver Vol#: 249

C 6714 L Tisdale Vol#: 249

C 6715 M Hohman Vol#: 249

C 6716 J Ringley Vol#: 249

C 6717 M Thomann Vol#: 249

C 6718 S Heymann Vol#: 249

C 6719 D Deakin Vol#: 249

C 6720 B Nelson Vol#: 249

C 6721 C Lonsberry Vol#: 249

C 6722 T Bronk Vol#: 249

C 6723 J Robida Vol#: 249

01D-0044 Clinical Laboratory Improvement Amendments of 1988

C 37 ARC, Ammirati Regulatory Consulting Vol#: 3

01D-0162 Using FDA-Approved Patient Labeling in Consumer-Directed

C 5 HRPC, Health Resourxce Publishing Co. Vol#: 1

01N-0197 Treatment of Ankylosing Spondylitis and Related Disorders

C 2 Merck & Co., Inc. Vol#: 1