DOCKETS ENTERED on 04/10/01

Docket Title

Number

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THE DOCUMENTS IN THE FOLLOWING DOCKETS WILL BE LINKED AS SOON AS POSSIBLE. CLICK ON THE (*) TO SEE THE CONTENTS OF THE LISTED DOCKET. SOME DOCKETS, NOT LINKED TO THIS TABLE OF CONTENTS, WILL BE LINKED ELSEWHERE ON THE DOCKETS PAGE

92N-0489 Taxol; Enviromental Assessments and Fonsi *

95S-0117 Human Drugs Patent Term Extension & New Patents *

97D-0448 Test Procedures & Acceptance Criteria for New Drug Subs. *

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

98D-0997 Metered dose Inhaler and Dry Powder Inhaler Drug Products *

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

98P-1194 Withdrawal NADA Approval for Posilac - rBGH *

99D-1454 Nasal spray, inhalation solution, suspension&spray drug prod *

00D-1595 Recommendations for Complying with the Pediatric Rule *

00D-1677 Use of Antimicrobial Drugs in Food-Producing Animals *

00N-0989 Human Gene Therapy *

00N-1685 New Food Chemicals Codex Monographs *

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

00P-1472 Over-the-counter sodium phosphate bowel preparation products *

01P-0066 ANADA which differs in dosage form from innovator product *

92N-0489 Taxol; Enviromental Assessments and Fonsi

EA 2 Paclitaxel Injection ANDA 75-297 Vol#: 1

95S-0117 Human Drugs Patent Term Extension & New Patents

LST 62 List as of April 6, 2001 Vol#: 4

96V-0409 Laser Light Show

VRA 2 HFZ-340 to Laser F/XS Vol#: 1

97D-0448 Test Procedures & Acceptance Criteria for New Drug Subs.

C 14 Generic Pharmaceutical Association Vol#: 1

97N-0135 OTC Test Sample Collection Systems

NFR 2 Vol#: 1

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

C 2 Community Blood Ctr/Community Tissue Svc Vol#: 4

C 3 Kerin Eberle Vol#: 4

C 4 Community Blood Ctr/Community Tissue Svc Vol#: 4

98D-0997 Metered dose Inhaler and Dry Powder Inhaler Drug Products

C 27 International Pharm Aerosol Consortium Vol#: 3

98N-0044 Effect of dietary supplement on structure/function of body

NAL 1 Vol#: 883

SS 1 SUPPORTING STATEMENT Vol#: 883

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

C 4469 Joy M. Zakarian, M,P.H. Vol#: 139

C 4470 Christine Toledo Vol#: 139

C 4471 Lura B. Irish Vol#: 139

C 4472 Margery Steinhouse Vol#: 139

C 4473 Eleanor Dvorchak Vol#: 139

C 4474 Sally A. Cumine Vol#: 139

C 4475 Jeff Priest, Ph.D. Vol#: 139

C 4476 V. J. Gettys Vol#: 139

C 4477 Stacey Murrow Vol#: 139

C 4478 Mrs. Jill Cresko Vol#: 139

C 4479 Jerry & Barbara Coalgate Vol#: 139

EMC 1660 Cheri Pawlak Vol#: 139

EMC 1661 Harriet Kalet Vol#: 139

EMC 1662 Rose Reina-Rosenbaum Vol#: 139

EMC 1663 Stan Wright Vol#: 139

EMC 1664 Dena C. Wiener Vol#: 139

EMC 1665 Sherry Althouse Vol#: 139

EMC 1666 Claire Ho Vol#: 139

EMC 1667 Sara Rod & Antonio Pontrelli Vol#: 139

EMC 1668 Majorie Hass Vol#: 139

EMC 1669 M. C. Finn Vol#: 139

EMC 1670 Nan & Greg Lewis Vol#: 139

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

EMC 192 Kathryn Foubister Vol#: 41

EMC 193 Susan L Augeri-Cosgrove Vol#: 41

EMC 194 Marshall McComb Vol#: 41

EMC 195 James Randles Vol#: 41

EMC 196 Alana Schwartz Vol#: 41

EMC 197 Vivien Richards PhD Vol#: 41

EMC 198 Michelle Law Vol#: 41

EMC 199 Sarah Jones Vol#: 41

EMC 200 Polly Peterson Vol#: 41

EMC 201 Maria Rogers Vol#: 41

EMC 202 Gene Ventura Vol#: 41

EMC 203 Sylvan Grey Vol#: 41

EMC 204 Lynn Montana Vol#: 41

EMC 205 Dana Natale Vol#: 41

EMC 206 Joni Simpson Vol#: 41

EMC 207 Cheryl Steets Vol#: 41

EMC 208 Suzy Latare Vol#: 41

EMC 209 Keith & Linda Copenhagen Vol#: 41

EMC 210 Cynthia Beckwith Vol#: 41

EMC 211 Hope Lucky Vol#: 41

EMC 212 Robin Callahan Vol#: 41

EMC 213 Allison Busch-Lovejoy Vol#: 41

EMC 214 Jeff Levy Vol#: 41

EMC 215 R Worrell Vol#: 41

EMC 216 Richard Sprentall Vol#: 41

EMC 217 Margaret Almekinder Vol#: 41

EMC 218 Wendy Babiak Vol#: 41

EMC 219 Andrew Pender Vol#: 41

EMC 220 NUMBER NOT USED Vol#: 41

EMC 221 Catherine Paetz Vol#: 41

EMC 222 Eric A Paetz Vol#: 41

EMC 223 Susan Soto Vol#: 41

EMC 224 J Keith Cook Vol#: 41

EMC 225 Monika Lewis Vol#: 41

EMC 226 Julie Freeman Vol#: 41

EMC 227 Elizabeth Hough Vol#: 41

EMC 228 P S Allison Vol#: 41

EMC 229 Bobbi Brunoehler Vol#: 41

EMC 230 Pat/Tanya Rable Collins Vol#: 41

EMC 231 Nadine Stafford Vol#: 41

EMC 232 Dr Robert L Groves Vol#: 41

EMC 233 Vivian Terry Vol#: 41

EMC 234 Danie Beltramo Vol#: 41

EMC 235 Brian C Lankford Vol#: 41

EMC 236 Tanya Okare Vol#: 41

EMC 237 Diana Wake Vol#: 41

EMC 238 NUMBER NOT USED Vol#: 41

EMC 239 Clea Allington Vol#: 41

EMC 240 Barbara Rubin Vol#: 41

EMC 241 Nancy Perigo Vol#: 41

EMC 242 Scott Buesing Vol#: 41

EMC 243 Marc Plesh Vol#: 41

EMC 244 Steve Klimenko Vol#: 41

EMC 245 Lynda Naughton Vol#: 41

EMC 246 Michelle Freeman Vol#: 41

EMC 247 Susan Golus Vol#: 41

EMC 248 Belinda Miller Vol#: 41

EMC 249 Sabrina Rohbot Vol#: 41

EMC 250 Al King Vol#: 41

99D-1454 Nasal spray, inhalation solution, suspension&spray drug prod

C 20 International Pharm Aerosol Consortium Vol#: 2

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

C 17300 Verna Rastle Vol#: 495

C 17301 Bob Kurland Vol#: 495

C 17302 Leonard & Patricia Miller Vol#: 495

C 17303 Pat Warner Vol#: 495

C 17304 Marian Stewart Vol#: 495

C 17305 Susan Koch Vol#: 495

C 17306 Donna Lee Wilson Vol#: 495

C 17307 Chester Vandergriff Vol#: 495

C 17308 Lucie M Duffy Vol#: 495

C 17309 Glenn Piel Vol#: 495

C 17310 Misty Reddish Vol#: 495

C 17311 Cari Sue Green Vol#: 495

C 17312 Constance Malloy Vol#: 495

C 17313 LeRoy Gillen Vol#: 495

C 17314 Carole A Yoder Vol#: 495

C 17315 Milton Ross Vol#: 495

C 17316 Elizabeth Jimenez Vol#: 495

C 17317 Edward F Miller Jr Vol#: 495

C 17318 Shirley T Dolan Vol#: 495

C 17319 Lucille A Busch Vol#: 495

C 17320 Chris Lamb Vol#: 495

C 17321 Charles & Regina Simmons Vol#: 495

C 17322 Lisa L Weaver Vol#: 495

C 17323 Lynn Henry Vol#: 495

C 17324 Inac Jebb Vol#: 495

C 17325 Reg Ferguson Vol#: 495

C 17326 Julia V Rudisill Vol#: 495

C 17327 John Micknal Vol#: 495

C 17328 Helen M Burns Vol#: 495

C 17329 Deborah S Rose MD Vol#: 495

C 17330 La Von Roy Vol#: 495

C 17331 Sharon L Jordan Vol#: 495

C 17332 Susan Berge Vol#: 495

C 17333 Audra Collins Vol#: 495

C 17334 Susan Keefer Vol#: 495

C 17335 Sally Kochendofer Vol#: 495

C 17336 James J Gentile Vol#: 495

C 17337 Susan Cook Vol#: 495

C 17338 Lyndall Alfoldy Vol#: 495

C 17339 Mickey M Nojiri Vol#: 495

C 17340 Lillian A Blair Vol#: 495

00D-1595 Recommendations for Complying with the Pediatric Rule

C 6 Procter & Gamble Pharmaceuticals Vol#: 1

C 7 AstraZeneca Vol#: 1

00D-1677 Use of Antimicrobial Drugs in Food-Producing Animals

C 3 American Veterinary Med Assn Vol#: 1

C 4 Environmental Consumer & Agricultural Gr Vol#: 1

C 5 Animal Health Institute (AHI) Vol#: 1

00N-0989 Human Gene Therapy

C 58 Suzanne Pease Vol#: 4

C 59 Martha Stavish Vol#: 4

C 60 Roberta Claypool Vol#: 4

C 61 National Hemophilia Foundation Vol#: 4

C 62 Howard Mann MD Vol#: 4

C 63 Alana F Turman Vol#: 4

C 64 Mr & Mrs Bob Johnson Vol#: 4

C 65 Mary Lou DeCruz Vol#: 4

C 66 Mr & Mrs Lary Stites Vol#: 4

EMC 132 Vira Moroz Vol#: 4

EMC 133 Carol Kuhn Vol#: 4

00N-1269 Labeling for human prescription drug/Biologic Products

NEC 1 Vol#: 3

00N-1425 Human Tissue Intended for Transplantation

NAL 1 Vol#: 1

SS 1 SUPPORTING STATEMENT Vol#: 1

00N-1467 Hepatitis B Surface Antigen;Agency Information Collection

NAL 1 Vol#: 1

SS 1 SUPPORTING STATEMENT Vol#: 1

00N-1511 Petition for Administrative Reconsideration of Action

NAL 1 Vol#: 1

SS 1 SUPPORTING STATEMENT Vol#: 1

00N-1604 Test Sample Collection Systems for Drugs of Abuse Testing

NAL 1 Vol#: 1

SS 1 SUPPORTING STATEMENT Vol#: 1

00N-1685 New Food Chemicals Codex Monographs

EMC 1 Rosalie Parker Vol#: 1

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

C 9680 E & P Weimer Vol#: 727

C 9681 M L Winburn Vol#: 727

C 9682 Janice W Neitzel Vol#: 727

C 9683 Heather E Robinson Vol#: 727

C 9684 Virginia Gregg Vol#: 727

C 9685 Not clear Vol#: 727

C 9686 Brian Vol#: 727

C 9687 Pat Carlson Vol#: 727

C 9688 Linda M Flores-Tober Vol#: 727

C 9689 Valery D Knox Vol#: 727

C 9690 Martha Oaklander Vol#: 727

C 9691 David Jensen Vol#: 727

C 9692 Mike O Smith Vol#: 727

C 9693 Gloria Mann Vol#: 727

C 9694 Julie Goldstein Vol#: 727

C 9695 Harold Hartmann Vol#: 727

C 9696 David Baxter Vol#: 727

C 9697 Amy Martin Vol#: 727

C 9698 Elaine Wright Vol#: 727

C 9699 Nancy Farr Vol#: 727

C 9700 Susan Gresia Vol#: 727

C 9701 Carolyn Webb Vol#: 727

C 9702 Phil Anderson Vol#: 727

C 9703 Jean Armstrong Vol#: 727

C 9704 Jessie Ortiz Vol#: 727

C 9705 Michael Jenng Vol#: 727

C 9706 Allison Williams Vol#: 727

C 9707 Abbie Lurie Vol#: 727

C 9708 Dr Susan Eissinger Vol#: 727

C 9709 David Hirt Vol#: 727

C 9710 Not clear Vol#: 727

C 9711 Joann Henderson Vol#: 727

C 9712 J Victor Vol#: 727

C 9713 Jon-Paul Maurin Vol#: 727

C 9714 Lillie Kocher Vol#: 727

C 9715 Colene Williams Vol#: 727

C 9716 Wendi Milka Vol#: 727

C 9717 Michael S Adler Vol#: 727

C 9718 Kenneth J Karr Vol#: 727

C 9719 Marie Branch Vol#: 727

C 9720 Gerry & Carole Chouinard Vol#: 727

C 9721 C R Cameron Vol#: 727

C 9722 Maureen O Dowd Vol#: 727

C 9723 Mary McNolt Vol#: 727

C 9724 karen Romani Vol#: 727

C 9725 Mona Morstein Vol#: 727

C 9726 John D Nelson, Jr, PhD Vol#: 727

C 9727 Amy Tapper Vol#: 727

C 9728 Nadine Schelly Vol#: 727

C 9729 Nell Benton Vol#: 727

C 9730 O J Lumphrey Vol#: 727

C 9731 Andrew Sharp Vol#: 727

C 9732 Bill Stanton Vol#: 727

C 9733 Charlotte R Wilson Vol#: 727

C 9734 David V Mitchell Vol#: 727

C 9735 N Ehlman Vol#: 727

C 9736 Paul Churchill Vol#: 727

C 9737 Susan S Krence Vol#: 727

C 9738 C T Corelett Vol#: 727

C 9739 Perry Barrett Vol#: 727

C 9740 Denise Melton-Todd Vol#: 727

C 9741 E Klinckmann Vol#: 727

C 9742 Lois Rowleu Vol#: 727

C 9743 Patti Hachney Vol#: 727

C 9744 Carolyn Rudolph Vol#: 727

C 9745 Mary McCormic-Mannis Vol#: 727

C 9746 Jane Allan Vol#: 727

C 9747 Jane Cartmell Vol#: 727

C 9748 Kathleen E Novak Vol#: 727

C 9749 Martha W King Vol#: 727

C 9750 Lynn de Vree Vol#: 727

C 9751 George Little Vol#: 727

C 9752 Barbara Hune Vol#: 727

C 9753 B C Keith Vol#: 727

C 9754 Mrs Stanley Hartman Vol#: 727

C 9755 Mrs Charlotte Waldman Vol#: 727

C 9756 Elizabeth W Morrissett Vol#: 727

C 9757 Fred Dolgn Vol#: 727

C 9758 Lila Boucher Vol#: 727

C 9759 Suzanne R Carlson Vol#: 727

C 9760 Linda O Streiden Vol#: 727

C 9761 Dr & Mrs Michael Skweir Vol#: 727

C 9762 Mark Ostrom Vol#: 727

C 9763 Abby Bogomoiny Vol#: 727

C 9764 Rosemarie Gresset Vol#: 727

C 9765 Karl Bernhard Vol#: 727

C 9766 M M Grifflin Vol#: 727

C 9767 Paul Ator Vol#: 727

C 9768 Christine Bard Vol#: 727

C 9769 Pamela Clark Vol#: 727

C 9770 Carole Rossi Vol#: 727

C 9771 Barbara Bacon Vol#: 727

C 9772 Andrew Tielman Vol#: 727

C 9773 David Ross Vol#: 727

C 9774 Harold Bourner Vol#: 727

C 9775 Saly Bulfud Vol#: 727

C 9776 jane Kelley Vol#: 727

C 9777 William D Gerhart Vol#: 727

C 9778 Arminta Hewitt Vol#: 727

C 9779 John Derdivanis Vol#: 727

C 9780 Stuart Williams Vol#: 727

C 9781 Donna Coyle Vol#: 727

C 9782 Betty Whittaker Vol#: 727

C 9783 Hallie Whitcomb Vol#: 727

C 9784 Charles Trembath Vol#: 727

C 9785 Manfred McArthur Vol#: 727

C 9786 Ms Frances Wolf Vol#: 727

C 9787 Marisue Zillig Vol#: 727

C 9788 Mrs Leonard Coleman Vol#: 727

C 9789 Marian Welch Vol#: 727

00P-1472 Over-the-counter sodium phosphate bowel preparation products

RC 3 C B Fleet Company Inc Vol#: 3

01F-0142 use of mixture of peroxyacetic acid,octanoic acid,acetic

EA 1 ENVIRONMENTAL ASSESSMENT Vol#: 1

NFL 1 Vol#: 1

01H-0065 Civil Money Penalty for First Check Home Drug Test Decives

CS 2 HFA-305 Vol#: 1

MO 2 Worldwide Medical Corporation Vol#: 1

OR 1 HF-3 Vol#: 1

01N-0132 Institutional Review Boards Agency info collection

N 1 Vol#: 1

01N-0134 Foods, Infant Formulas and Dietary Supplements

NFR 1 Vol#: 1

01P-0066 ANADA which differs in dosage form from innovator product

PAV 1 HFV-100 to First Priority, Inc. Vol#: 1