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 March 15, 2001

TABLE OF CONTENTS

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98N-1038 Irradiation in the production, processing, &handling of food *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99P-2247 Propoxyphene Napsylate/Acetaminophen 100mg/325mg *
99P-4107 ANDA Suitability for Certain Oploid Analgesic Elixir Drugs *
99P-4649 Propoxyphene Napsylate/Acetaminophen Tablets/Capusles 50mg *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-1276 Health Claim: Plant stanol esters and heart disease *
00P-1499 Remove alosetron (Lotronex) from the market *
00P-1510 Establish safety of Echinacea extract as a GRAS pharmaceutic *
87V-0401 Laser lighting effects

VRA 7 HFZ-300 Vol#: 1

97P-0350 Reclassify Home Uterine Activity Monitors from III to II

NFR 1 Vol#: 5

98N-1038 Irradiation in the production, processing, &handling of food

C 5241 Form Letters count 5 Vol#: 157

C 5242 Lorraine O. Gloede Vol#: 156

EMC 310 Pam Hawkins Vol#: 156

EMC 311 Maija Anderson Vol#: 156

EMC 312 National Consumers League Vol#: 156

EMC 313 Colleen Bates Vol#: 156

LET 7 HF-40 Vol#: 156

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

C 4139 K. C. Davies Vol#: 130

C 4140 Joyce Bolton Vol#: 130

C 4141 Joseph Zuwatsky Vol#: 130

C 4142 Jamey Lee West Vol#: 130

C 4143 Joanne R. Kresic Vol#: 130

C 4144 Mr. Booth K. Bender Vol#: 130

C 4145 Susan Kline Vol#: 130

C 4146 Jerri Brandt Vol#: 130

C 4147 Dawn Clegg Vol#: 130

C 4148 Dorothy C. Ramsaier Vol#: 130

C 4149 Ms. Carol Baier Vol#: 130

C 4150 Mr. Judd Vol#: 130

C 4151 A. Werner Vol#: 130

C 4152 Renee Ladd Vol#: 130

C 4153 Theresa A. Keene Vol#: 130

C 4154 Suzanne House Vol#: 130

C 4155 Marie L. Smith Vol#: 130

C 4156 Nancy Zebracki Vol#: 130

C 4157 Karen Thompson Vol#: 130

C 4158 Holiday E. Adair, Ph.D. Vol#: 130

C 4159 Elaine Van Gunst Vol#: 130

C 4160 J. Campbell Vol#: 130

C 4161 Naomi Warner Vol#: 131

C 4162 Heather Palmateer Vol#: 131

C 4163 Rosemarie Schilling Vol#: 131

C 4164 Suzanne Pease Vol#: 131

C 4165 Susan Lamb Vol#: 131

C 4166 Irene Mostek Vol#: 131

C 4167 Jessica Bushore Vol#: 131

C 4168 Dorothy C. Beaver Vol#: 131

C 4169 Susan Dudley Vol#: 131

C 4170 Lisa Meyer et al Vol#: 131

C 4171 Kate Dorr Vol#: 131

C 4172 Gladys E. Chiaffitelli Vol#: 131

C 4173 Mr. Hugh P. McElrath Vol#: 131

C 4174 Nan Cardella Vol#: 131

C 4175 The Humane Society of the United States Vol#: 131

C 4176 J. Capozzelli Vol#: 131

C 4177 Allison Marie Memmo Geiger Vol#: 131

C 4178 Lewis E. Neiman Vol#: 131

EMC 1381 Jane Wells Vol#: 130

EMC 1382 Kristina A. Gray Vol#: 130

EMC 1383 Sam Calaby Vol#: 130

EMC 1384 Than Saffel Vol#: 130

EMC 1385 Klara Miller Vol#: 130

EMC 1386 number not used Vol#: 130

EMC 1387 N T. W Vol#: 130

EMC 1388 Dr. Laurie Powell Vol#: 130

EMC 1389 Marna M. Rusher Vol#: 130

EMC 1390 Shirley Allen Vol#: 130

EMC 1391 Melinda Vol#: 130

EMC 1392 Justin Sivey Vol#: 130

EMC 1393 Garry Klicker Vol#: 130

EMC 1394 Camilla Turnage Vol#: 130

EMC 1395 George Antonio Vol#: 130

EMC 1396 Karen Kaminsky Vol#: 130

EMC 1397 Barbara Vol#: 130

EMC 1398 Regina Barnes Vol#: 130

EMC 1399 number not used Vol#: 130

EMC 1400 Lydia Perry Vol#: 130

EMC 1401 Dr. Daniel T. Wagner Vol#: 130

99D-1817 Home Uterine Activity Monitors Guidance

GDL 2 GUIDANCE Vol#: 1

NAD 2 Vol#: 1

99E-1071 Provigil, Patent No. 4,177,290

N 1 Vol#: 1

99P-2247 Propoxyphene Napsylate/Acetaminophen 100mg/325mg

PDN 1 HFD-600 to Mikart, Inc. Vol#: 1

99P-4107 ANDA Suitability for Certain Oploid Analgesic Elixir Drugs

PDN 1 HFD-600 Vol#: 1

99P-4649 Propoxyphene Napsylate/Acetaminophen Tablets/Capusles 50mg

PDN 1 HFD-600 Vol#: 1

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 258 M J Mayo Vol#: 24

C 259 R L Christie Vol#: 24

C 260 A & R Morris Vol#: 24

C 261 M C LaFrance Vol#: 24

EMC 614 Form Letter Count Vol#: 27

EMC 615 Form Letter Count Vol#: 28

EMC 616 Form Letter Count Vol#: 29

EMC 617 A Nowacki Vol#: 21

EMC 618 V Peters Vol#: 21

EMC 619 G Landers Vol#: 21

EMC 620 G & D Peters Vol#: 21

EMC 621 B Neuman Vol#: 21

EMC 622 T Shtatland Vol#: 21

EMC 623 L Shustha Vol#: 21

EMC 624 C Ford-McCullough Vol#: 21

EMC 625 J Trezza Vol#: 21

EMC 626 C Lennon Vol#: 21

EMC 627 Number not used Vol#: 21

EMC 628 T Mulligan Vol#: 21

EMC 629 T Coto Vol#: 21

EMC 630 L Dvorak Vol#: 21

EMC 631 D Posada Vol#: 21

EMC 632 N Bertrando Vol#: 21

EMC 633 E Miller Vol#: 21

EMC 634 NO MORE EVIL CORN Vol#: 21

EMC 635 Y Novak Vol#: 21

EMC 636 B Wilson Vol#: 21

EMC 637 A Vetter Vol#: 21

EMC 638 J Yancey Vol#: 21

EMC 639 M K Serrine Vol#: 21

EMC 640 B King Vol#: 21

EMC 641 A Funston Vol#: 21

EMC 642 W Osterman Vol#: 21

EMC 643 A Kushner Vol#: 21

EMC 644 L R Lewis & Family Vol#: 21

EMC 645 G B Gray Vol#: 21

EMC 646 E Beighley Vol#: 21

EMC 647 G Laney Vol#: 21

EMC 648 A Fasolo, Jr. Vol#: 21

EMC 649 K Simms Vol#: 21

EMC 650 B C Hood Vol#: 21

EMC 651 E Price Vol#: 21

EMC 652 C Bryant Vol#: 21

EMC 653 Dr. N Oderberg Vol#: 21

EMC 654 K Carlise Vol#: 21

EMC 655 M Lafkas Vol#: 21

EMC 656 C Holverson Vol#: 21

EMC 657 V Britto Vol#: 21

EMC 658 E Friedman Vol#: 21

EMC 659 Dahtep Vol#: 21

EMC 660 J Newman Vol#: 21

EMC 661 P Conte Vol#: 21

EMC 662 A Lindsey Vol#: 21

EMC 663 T Hart Vol#: 21

EMC 664 D Pavlak Vol#: 21

EMC 665 R Fessenden Vol#: 21

EMC 666 L Mole Vol#: 21

EMC 667 A Water Vol#: 21

EMC 668 E Weaver Vol#: 21

EMC 669 L Douglas Vol#: 21

00P-1276 Health Claim: Plant stanol esters and heart disease

C 16 Raisio Benecol Ltd Vol#: 12

00P-1499 Remove alosetron (Lotronex) from the market

EC 1 Mr. william garver Vol#: 3

00P-1510 Establish safety of Echinacea extract as a GRAS pharmaceutic

LET 1 HFD-1 to Pharmaceutical Consulting Vol#: 4

01D-0079 Acceptance of Foreign Clinical Studies

GDL 2 GUIDANCE Vol#: 1

01D-0107 Expedited Review NADA for Human Pathogen Reduction Claims

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

01V-0128 Mobolazer ML10-200,ML10-300,ML10-300W,ML10-1000

ACK 1 HFA-305 Vol#: 1

VAR 1 Red Zone Vol#: 1


Page update January 26, 2004