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DOCKETS ENTERED on January 29, 2001

TABLE OF CONTENTS

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98P-0151 Introduction Of Downed Cattle Into The Food Supply *
00D-1537 Discontinued Labeling for Listed Drugs in ANDA *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00D-1601 Guidance for Industry and for FDA Employees on Import Alert *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
01R-0016 Disqualification of Chaovanee Aroonsakul MD *
01R-0017 Disqualification of Paul W Boyles MD *
01R-0018 Disqualification of Abraham A Chaplan MD *
01R-0019 Disqualification of William L Doss Jr MD *
01R-0020 Disqualification of Edward C Froning MD *
01R-0021 Disqualification of Ronald R Fuller, DVM *
01R-0022 Disqualification of Michael C Gelfand MD *
01R-0023 Disqualification of E Alan Paulk Jr MD *
01R-0024 Disqualification of Steven K Teplick MD *
01R-0035 Disqualification of James A Halikas, MD *
98P-0151 Introduction Of Downed Cattle Into The Food Supply

C 3427 Ms. Linda Shea Vol#: 108

C 3428 Domnica E. Bottea Vol#: 108

C 3429 Joan H. Mooney Vol#: 108

C 3430 Eileen Roach Vol#: 108

C 3431 Amercan Business Forms & Promotions Vol#: 108

C 3432 Individual Consumer Vol#: 108

C 3433 Charmaine Liccardi Vol#: 108

C 3434 Norma W. Allen Vol#: 108

C 3435 Jill Sidor Vol#: 108

EMC 606 Elizabeth Glixman Vol#: 108

EMC 607 Peggy Wareham Vol#: 108

EMC 608 Alan & Helene Schwartz Vol#: 108

EMC 609 Pam Lawless Vol#: 108

EMC 610 Paula McKenna Vol#: 108

EMC 611 Julie Fernee, RN Vol#: 108

EMC 612 Cynthia Embree-Lavoie Vol#: 108

EMC 613 Dr. Henry Hambel Vol#: 108

EMC 614 Lanette Rapp Vol#: 108

EMC 615 Mike, Anita & Rachel Weinberg Vol#: 108

EMC 616 Phoenix Children's Hospital Vol#: 108

EMC 617 Lynne & Eric Smith Vol#: 108

EMC 618 Adele Pisarevsky Vol#: 108

EMC 619 Cynthia Risley Vol#: 108

EMC 620 number not used Vol#: 108

EMC 621 Win 123 some Vol#: 109

EMC 622 Kimberly J. Sharp Vol#: 109

EMC 623 E. H. Butler Vol#: 109

EMC 624 Elaine Ritchey Vol#: 109

EMC 625 Liane Salgado Vol#: 109

EMC 626 Lois Angeletti Vol#: 109

EMC 627 Kathleen R. Tauro Vol#: 109

EMC 628 Robin Stout Vol#: 109

EMC 629 Noelle Hartner Vol#: 109

EMC 630 Diana Moreton Vol#: 109

EMC 631 Ruth A. Brown Vol#: 109

EMC 632 Robert Story Vol#: 109

EMC 633 Randall Smith Vol#: 109

EMC 634 Morello Family Vol#: 109

EMC 635 Dawn Pace Vol#: 109

EMC 636 Lisa Capozzella Vol#: 109

EMC 637 Barb Adamus Vol#: 109

EMC 638 Barbara Biel Vol#: 109

EMC 639 Phyllis Deal Vol#: 109

EMC 640 Daniela Loewenson Vol#: 109

EMC 641 Nicholas Gausling Vol#: 109

EMC 642 Their Caretakers, Karryn Hart, Sharyn Vol#: 109

EMC 643 Patricia M. Nelson Vol#: 109

EMC 644 Wendy Lochner Vol#: 109

EMC 645 Lindsey Keener Vol#: 109

EMC 646 Mrs. Susan Gensinger Vol#: 109

EMC 647 G. Acampora Vol#: 109

EMC 648 Gayle Janzen Vol#: 109

EMC 649 G. Parello Vol#: 109

EMC 650 Shirley Gellis Vol#: 109

EMC 651 J. Handler Vol#: 109

00D-1537 Discontinued Labeling for Listed Drugs in ANDA

C 1 Bristol-Myers Squibb Co. Vol#: 1

C 2 Johnson & Johnson Vol#: 1

C 3 Purepac Pharmaceutical Co. Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

EMC 68 Thomas Taylor Vol#: 3

EMC 69 Anita Ellababidy Vol#: 3

EMC 70 James Swaney Vol#: 3

EMC 71 Mary E. Riley Vol#: 3

EMC 72 Charles Scamman Vol#: 3

EMC 73 Amy Hartmann Vol#: 3

EMC 74 Toni West Vol#: 3

EMC 75 Sharon Watkins Vol#: 3

EMC 76 Arlene Turner Vol#: 3

EMC 77 Coeta Mills Vol#: 3

EMC 78 Janis Ihrig Vol#: 3

EMC 79 Julie Bowdle Vol#: 3

EMC 80 Katherine Manville Vol#: 3

EMC 81 Richard Ferguson Vol#: 3

EMC 82 Sandy Pethan Vol#: 3

EMC 83 Matt Schwartz Vol#: 3

EMC 84 Debra Peterson Vol#: 3

EMC 85 Lynda A. James Vol#: 3

EMC 86 Dane Kuppinger Vol#: 3

EMC 87 Donnalara Smith Vol#: 3

EMC 88 John Hutchinson Vol#: 3

EMC 89 Sylvia Redmond Vol#: 3

EMC 90 Monica Lipscomb Vol#: 3

EMC 91 Karen Isaacson Vol#: 3

EMC 92 Gary Smith Vol#: 3

EMC 93 Elizabeth Cullen Vol#: 3

EMC 94 D. Ranosta Vol#: 3

EMC 95 Dr. Richard Allen Vol#: 3

EMC 96 Neo Paris Vol#: 3

EMC 97 Liam Antrim Vol#: 3

EMC 98 Mary Nelson Vol#: 3

EMC 99 John Fisher Vol#: 3

EMC 100 Fatima Castaneda Vol#: 3

EMC 101 Amy Conry Vol#: 3

EMC 102 Caleb T. Deupree Vol#: 3

EMC 103 Lisa Davis Vol#: 3

EMC 104 Sally Kieny Vol#: 3

EMC 105 Andra Granek Vol#: 3

EMC 106 Jonathan Logan, Esq Vol#: 3

EMC 107 Diane Dee Vol#: 3

EMC 108 Yvonne Gillette Vol#: 3

EMC 109 Malissa Schiermeyer Vol#: 3

EMC 110 Melissa Estes Vol#: 3

EMC 111 Judy Reed Vol#: 3

EMC 112 Karen Fisher Vol#: 3

EMC 113 Patricia Snouffer Vol#: 3

EMC 114 Tim Gallaher Vol#: 3

EMC 115 Mccormick Tedd Vol#: 3

EMC 116 Number Not Used Vol#: 3

EMC 117 Kate Munson Vol#: 3

EMC 118 Theresa Perker Vol#: 3

EMC 119 PJ Stentz Vol#: 3

EMC 120 Hannah Mitchell Vol#: 3

EMC 121 Jesse Herbert Vol#: 3

EMC 122 Taryn Hall Vol#: 3

EMC 123 Jan Muehlhauser Vol#: 3

EMC 124 Patricia Bennett Vol#: 3

EMC 125 Patricia Bennett Vol#: 3

EMC 126 John Kimble Vol#: 3

EMC 127 Roberta Harper-McIntosh Vol#: 3

EMC 128 Dawn Flinn Vol#: 3

EMC 129 Carla Atkinson Vol#: 3

EMC 130 Molly Van Meter Vol#: 3

EMC 131 Donna Quilter Vol#: 3

EMC 132 Philip H. Coe Vol#: 3

EMC 133 Lizabeth Collie Vol#: 3

EMC 134 Kathy Jaffey Vol#: 3

EMC 135 Number Not Used Vol#: 3

EMC 136 Lauren Darges Vol#: 3

EMC 137 Leigh Klein Vol#: 3

EMC 138 Marilyn E. Clare Vol#: 3

EMC 139 Number Not Used Vol#: 3

EMC 140 David Whitehouse Vol#: 3

EMC 141 Paul Moss Vol#: 3

EMC 142 Graham Dunn Vol#: 3

EMC 143 Valerie Bridges Vol#: 3

EMC 144 Elaine Stauffer Vol#: 3

EMC 145 Myrna Kitchens Vol#: 3

EMC 146 Robert Flood Vol#: 3

EMC 147 Amy Josephson Vol#: 3

EMC 148 Christy Waehner Vol#: 3

EMC 149 Grant Abert Vol#: 3

EMC 150 Kris Schamp Vol#: 3

EMC 151 C.A. Hilgartner Vol#: 3

EMC 152 Shirley Emerson Vol#: 3

EMC 153 Stacie Sandoval Vol#: 3

EMC 154 Dr. N Zirpolo Vol#: 3

EMC 155 Number Not Used Vol#: 3

EMC 156 Eden Danaher Vol#: 3

EMC 157 Paul Marucci Vol#: 3

EMC 158 Robert C.H. Harvey Vol#: 3

EMC 159 Verna Blanc Vol#: 3

EMC 160 David Fowle Vol#: 3

EMC 161 Jennifer Moix Vol#: 3

EMC 162 Neil Ray Vol#: 3

EMC 163 Peter Davies Vol#: 3

EMC 164 Elizabeth Morris Vol#: 3

EMC 165 David Crosweller Vol#: 3

EMC 166 Lisa Jones Vol#: 3

EMC 167 Number Not Used Vol#: 3

EMC 168 Katherine Holmes Vol#: 3

EMC 169 Monica Cardoza Vol#: 3

EMC 170 Ed Keller Vol#: 3

EMC 171 Heather Spencer Vol#: 5

EMC 172 Joan Taylor Vol#: 5

EMC 173 Jennifer Stock Vol#: 5

EMC 174 Polly Gray Vol#: 5

EMC 175 Donna Chappell Vol#: 5

EMC 176 Catherine Lozeau Vol#: 5

EMC 177 Sarah Ames Vol#: 5

EMC 178 Lynette Dobler Vol#: 5

EMC 179 Charles Martinet Vol#: 5

EMC 180 Teralyn Tanner Vol#: 5

EMC 181 Anna Fitzpatrick Vol#: 5

EMC 182 Lindsey Mann Vol#: 5

EMC 183 Jane A. Malkoff Vol#: 5

EMC 184 Mark Pierce Vol#: 5

EMC 185 Willow Whitton Vol#: 5

EMC 186 Phillip Robinson Vol#: 5

EMC 187 Louisa Rose Vol#: 5

EMC 188 Finesse Lapins Vol#: 5

EMC 189 Marie Coccia Vol#: 5

EMC 190 Shirley & Milton Paul Vol#: 5

EMC 191 Shirley & Milton Paul Vol#: 5

EMC 192 Michelle Grossman Vol#: 5

EMC 193 Ann Miller Vol#: 5

EMC 194 Michele Boning Amy Vol#: 5

EMC 195 Kathy C. Shepard Vol#: 5

EMC 196 Mr. Kelly Minehan Vol#: 5

EMC 197 Jack Ossont Vol#: 5

EMC 198 Duncan Leaf Vol#: 5

EMC 199 Marlene Ress Vol#: 5

EMC 200 Sarah Miller Vol#: 5

EMC 201 J.L. Carpenter Vol#: 5

EMC 202 Nilda Puig Vol#: 5

EMC 203 Kathy Kohl Vol#: 5

EMC 204 Kim Pisinski Vol#: 5

EMC 205 Carissa Pastuch Vol#: 5

EMC 206 Susan Caruana Vol#: 5

EMC 207 Kalila Volkav Vol#: 5

EMC 208 Heather Morgan Vol#: 5

EMC 209 Eva Lewis Vol#: 5

EMC 210 Penny Claringbull Vol#: 5

EMC 211 Michael Fine Vol#: 5

EMC 212 Judy Mckie Vol#: 5

EMC 213 Mary Wildfire Vol#: 5

EMC 214 James Toth Vol#: 5

EMC 215 Linda Kirschner Vol#: 5

EMC 216 Alene Nordin Vol#: 5

EMC 217 Steve Leuty Vol#: 5

EMC 218 Juliana Harrison Vol#: 5

EMC 219 Jean Van Meter Vol#: 5

EMC 220 William Hawstback Vol#: 5

EMC 221 Jerry Erickson Vol#: 5

00D-1601 Guidance for Industry and for FDA Employees on Import Alert

C 3 Merck & Co., Inc. Vol#: 1

00M-1592 P970043/S005; LADARVision Excimer Laser System

AAV 1 Autonomous Technologies Corporation Vol#: 1

00N-1396 Bioengineered Foods Consumed By Humans or Animals

EMC 1 S. Burke Vol#: 3


00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

EMC 249 Form Letter Count (16926) Vol#: 21

01E-0053 Patent Extension for Diphenylmethane diisocyanate, 4,968,514

APP 1 Forbes Polytech, Inc. Vol#: 1

LET 1 Dept of Commerce, Patent & Trademark Vol#: 1

01M-0038 P950021/S002; ACS:180 & Advia Centaur PSA Assays

AAV 1 Bayer Corporation Vol#: 1

01M-0039 P000022; Medtronic AVE BeStent 2 with Discrete Technology

AAV 1 Medtronic AVE, Inc. Vol#: 1

01M-0041 P910023/S47; Photon DR ICD System

AAV 1 St. Jude Medical, Inc. Vol#: 1

01M-0042 P000009; Phylax AV Implantable Cardioverter Defibrillator

AAV 1 Biotronik, Inc. Vol#: 1

01M-0043 P970049; Dishler Excimer Laser System

AAV 1 Laser Institute of the Rockies Vol#: 1

01R-0016 Disqualification of Chaovanee Aroonsakul MD

CMD 1 HF-1 Vol#: 1

RPT 1 President Officers Report Vol#: 1

01R-0017 Disqualification of Paul W Boyles MD

CMD 1 HF-1 Vol#:

RPT 1 President Officers Report Vol#: 1

01R-0018 Disqualification of Abraham A Chaplan MD

CMD 1 HF-1 Vol#: 1

RPT 1 President Officers Report Vol#: 1

01R-0019 Disqualification of William L Doss Jr MD

CMD 1 HF-1 Vol#: 1


01R-0020 Disqualification of Edward C Froning MD

CMD 1 HF-1 Vol#: 1

RPT 1 President Officers Report Vol#: 1


01R-0021 Disqualification of Ronald R Fuller, DVM

CMD 1 HF-1 Vol#: 1

RPT 1 President Officers Report Vol#: 1

01R-0022 Disqualification of Michael C Gelfand MD

CMD 1 HF-1 Vol#: 1


01R-0023 Disqualification of E Alan Paulk Jr MD

CMD 1 HF-1 Vol#: 1

RPT 1 President Officers Report Vol#: 1

01R-0024 Disqualification of Steven K Teplick MD

CMD 1 HF-1 Vol#: 1

RPT 1 President Officers Report Vol#: 1

01R-0035 Disqualification of James A Halikas, MD

CMD 1 HF-1 Vol#: 1

RPT 1 President Officers Report Vol#: 1