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 7, 2001

TABLE OF CONTENTS

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94S-0120 510K Substantially Equivalent List *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
00D-1595 Recommendations for Complying with the Pediatric Rule *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00D-1679 Draft CPG for FDA Employees & Industry on Blood Donor Incent *
00N-0989 Human Gene Therapy *
00P-1330 Regulation approving the dosage approved for drug Propecia *
01D-0005 Labeling OTC Human Drug Products;Updating Labeling in ANDA's *
01D-0044 Clinical Laboratory Improvement Amendments of 1988 *
01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC *
01P-0120 Ban Unsafe IV Catheters and other Devices *
94S-0120 510K Substantially Equivalent List

LST 103 List of February 2001

Vol#: 25

98E-0476 Infergen(interferon alfacon-1)U.S.Patent Ext #4,695,623

LET 3 HFD-1 to U S Patent & Trademark Office Vol#: 1

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

C 4077 Jamie Korack Vol#: 127

EMC 1284 Jerri Miller Vol#: 127

EMC 1285 Vegetarian Society of Richmond VA. Vol#: 127

EMC 1286 Roberta Swanson Vol#: 127

EMC 1287 Steve Kane Vol#: 127

EMC 1288 Alok Health Vol#: 127

EMC 1289 Connie Simpson Vol#: 127

EMC 1290 Mark M. Giese Vol#: 127

EMC 1291 Brenda Morris Vol#: 127

EMC 1292 Bill Funt Vol#: 127

EMC 1293 number not used Vol#: 127

EMC 1294 Nedim C. Buyukmihci, V.M.D. Vol#: 127

EMC 1295 Ann Shillinglaw Vol#: 127

EMC 1296 Patricia Roberts Vol#: 127

EMC 1297 Lesley Parker-Rollins Vol#: 127

EMC 1298 Kimberly Bavos Vol#: 127

EMC 1299 Terri Hunnicutt Vol#: 127

EMC 1300 Jane M. Jackson Vol#: 127

EMC 1301 Julie Cross Vol#: 127

EMC 1302 Allison Anderson Vol#: 127

EMC 1303 Kristin Martin Vol#: 127

EMC 1304 Victoria & Andrew Housley Vol#: 127

EMC 1305 Monique Hoskins Vol#: 127

EMC 1306 Donna Cray Vol#: 127

EMC 1307 Al Perez Vol#: 127

EMC 1308 Dezum Vol#: 127

EMC 1309 Brandy Lucas Vol#: 127

EMC 1310 Patricia Stoll Vol#: 127

EMC 1311 Kristen Benney Vol#: 127

EMC 1312 Collette L. Adkins Giese Vol#: 127

EMC 1313 Ritchie Margaret & Ronald Laymon J.D, Ph Vol#: 127

EMC 1314 Mary Faber Vol#: 127

EMC 1315 Grace Van Vleck Vol#: 127

99N-1075 Vibrio Parahaemolyticus in molluscan shellfish public health

NAD 2 Vol#: 1

NM 3 Vol#: 1

99N-1168 Public Health Impact of Foodborne Listeria Monocytogenes

N 1 Vol#: 1

NM 3 Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

EMC 470 G Sittmann Vol#: 203

EMC 471 Carol Marcus Vol#: 203

EMC 472 Bengt Bjarngard PhD Vol#: 203

EMC 473 Bonnie McLean Vol#: 203

EMC 474 Susan Baker Vol#: 203

EMC 475 Linda Coonrod Vol#: 203

EMC 476 Bill Cosentino Vol#: 203

EMC 477 Janice Cragnolin Vol#: 203

EMC 478 Frank Caruthers Vol#: 203

EMC 479 Richard K Bestwick PhD Vol#: 203

EMC 480 Natasha Strawn Vol#: 203

EMC 481 Nicole Faaborg Vol#: 203

EMC 482 Verilee Herpich Vol#: 203

EMC 483 Elinor Thomforde Vol#: 203

EMC 484 Louis R Phillips Vol#: 203

EMC 485 Wayne Porter Vol#: 203

EMC 486 Deborah Torgerson Vol#: 203

EMC 487 Andrea & Steve Wolfert Vol#: 203

00D-1595 Recommendations for Complying with the Pediatric Rule

C 1 Aventis Pharmaceuticals Vol#: 1

C 2 Bristol-Myers Squibb Pharmaceutical Rese Vol#: 1

C 3 American Academy of Pediatrics Vol#: 1

C 4 PhRMA Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

EC 183 Ms. Jamie Wojtasinski Vol#: 43

EC 184 self Vol#: 43

EC 185 Ms. Susan Reed Vol#: 43

EC 186 Ms. Julia Garrison Vol#: 43

EC 187 Ms. Katherine Houston Vol#: 43

EC 188 Miss Cyndi Shultz Vol#: 43

EC 189 Ms. Barbara Parcells Vol#: 43

EC 190 Rose Academy Vol#: 43

EC 191 none Vol#: 43

EC 192 Mr. Edward Sonnenblick Vol#: 43

00D-1679 Draft CPG for FDA Employees & Industry on Blood Donor Incent

C 3 A Thom Vol#: 1

C 4 Maimonides Medical Center Vol#: 1

00N-0989 Human Gene Therapy

C 5 Brigham & Women's Hosp Vol#: 40

C 6 Robert L Trimble Vol#: 40

C 7 Nat'l Org for Rare Disorders Inc Vol#: 40

C 8 The Peaceful Kingdom Allce 4 Animals Inc Vol#: 40

EMC 14 Bobbie D Flowers Vol#: 40

EMC 15 NUMBER NOT USED Vol#: 40

EMC 16 Dawn Masturzo Vol#: 40

EMC 17 Susan L Christie Vol#: 40

EMC 18 Joseph W Bateman Vol#: 40

EMC 19 Alexsandra Kyrzakos Vol#: 40

EMC 20 Chris Striegel Vol#: 40

EMC 21 Ilaria Ferri Vol#: 40

EMC 22 Stephanie Booth Vol#: 40

EMC 23 Tracy Jordan Vol#: 40

EMC 24 Laura Greppi Vol#: 40

EMC 25 Renata Morelli Vol#: 40

EMC 26 R Reichert Vol#: 40

EMC 27 Kerry-Ann Stanley Vol#: 40

EMC 28 Stefania Pes Alessandria Vol#: 40

EMC 29 Sandy Kraegel Vol#: 40

EMC 30 Randall Smith Vol#: 40

EMC 31 Greg Fleenor Vol#: 40

EMC 32 Christiana Soccini Vol#: 40

EMC 33 Letizia Cuscela Vol#: 40

EMC 34 Shirley J Cofresi Vol#: 40

EMC 35 Dana Gemer Vol#: 40

EMC 36 Margaret Weston Vol#: 40

EMC 37 Margaret Weston Vol#: 40

EMC 38 Margaret Weston Vol#: 40

EMC 39 Margaret Weston Vol#: 40

EMC 40 Peggy Wareham Vol#: 40

EMC 41 Cam J Martinez Vol#: 40

EMC 42 Masimiliano Esposito Vol#: 40

00P-1330 Regulation approving the dosage approved for drug Propecia

ANS 1 HFD-1 to University of Pennsylvania Vol#: 1

LET 1 University of Pennsylvania Vol#: 1

01D-0005 Labeling OTC Human Drug Products;Updating Labeling in ANDA's

C 1 Satonja Gilbert Vol#: 1

01D-0044 Clinical Laboratory Improvement Amendments of 1988

C 1 Ed Prichard Vol#: 1

01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC

C 6 Helen Gruhn Vol#: 2

EMC 120 Cecilia Taphorn Vol#: 2

EMC 121 Bill Hughes Vol#: 2

EMC 122 Yale University Vol#: 2

EMC 123 David Kolf (Japaan) Vol#: 2

EMC 124 Doug Zeitz Vol#: 2

EMC 125 Natalie Ckelstowski Vol#: 2

EMC 126 Patricia Stebbins Vol#: 2

EMC 127 Dr. Kateryna Cuddeback Vol#: 2

EMC 128 Karen Perry Vol#: 2

EMC 129 Colleen Beard Vol#: 2

EMC 130 Mary Matheson Vol#: 2

EMC 131 Bob Guerin Vol#: 2

EMC 132 Suzanne Haines Vol#: 2

EMC 133 Doug Burford (Pastor) Vol#: 2

EMC 134 Jean Goad Vol#: 2

EMC 135 Jerome D. Stluka Vol#: 2

EMC 136 John Klein Vol#: 2

EMC 137 Will Rickey Vol#: 2

EMC 138 Sharon Reinan Vol#: 2

EMC 139 Mr. & Mrs. Edward Podlinsek Vol#: 2

EMC 140 Mary Ellen Waterman Vol#: 2

EMC 141 Bonnie L. Searcy Vol#: 2

EMC 142 Sandwags Vol#: 2

EMC 143 Mark P. Mesco Vol#: 2

EMC 144 Maria S. Lozano Vol#: 2

EMC 145 Helen Bryant Vol#: 2

EMC 146 Geraldine C. Schlitz Vol#: 2

EMC 147 Phyl Morello Vol#: 2

EMC 148 Gerald Berning Vol#: 2

EMC 149 Patricia Alleman Vol#: 2

EMC 150 Mr. & Mrs. Leonard Dezelski Vol#: 2

EMC 151 Kyle Beiter Vol#: 2

EMC 152 Craig Sexton Vol#: 2

EMC 153 Mike Henstrom Vol#: 2

EMC 154 Dave F. Lieuwen Vol#: 2

EMC 155 Brian Richard Vol#: 2

EMC 156 Mobility Customer Solutions Wireless Net Vol#: 2

EMC 157 Melissa Borer Vol#: 2

EMC 158 Maria Vaughan Vol#: 2

EMC 159 Lynn Killian Vol#: 2

EMC 160 Mary K. Pilewski Vol#: 2

EMC 161 Laura & Patrick Fritz Vol#: 2

EMC 162 Susan Turner Vol#: 2

EMC 163 Don Williams Vol#: 2

EMC 164 Zerry Greenwood Vol#: 2

EMC 165 B. Graham Vol#: 2

EMC 166 Connie Mesco Vol#: 2

EMC 167 Tamee Hatch Vol#: 2

EMC 168 Marcela Frescott Vol#: 2

01P-0120 Ban Unsafe IV Catheters and other Devices

ACK 1 HFA-305 Vol#: 1

CP 1 Public Citizen Hlth Research Group Vol#: 1

01V-0118 LPD9000,Q-BeamSeries Q-40(RG)(MC),Q-100G,Q-150G,Q175G,Q500G

ACK 1 HFA-305 Vol#:

01V-0121 Q-Beam Series,Q-40(RG)(MC),Q-100G,Q175G,Q500G

VAR 1 Rave Review Vol#: 1