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 May 30, 2002

TABLE OF CONTENTS

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82N-0291 Vaginal Drug Products for OTC Human Use *
98P-1121 Grated Parmesan Cheese Deviating from Identity standard *
00N-1571 Enrofloxacin for Poultry: Opportunity for hearing *
01D-0577 Class II Special Controls Guidance Cutaneous Carbon Dioxide *
01N-0322 Institutional Review Boards *
01N-0548 Guidelines for Voluntary Nutrition Labeling of Raw Fruits *
01P-0447 Withdrawn for Safety or Effectivess of Ardeparin Sodium *
02D-0081 Hepatitis B Surface Antigen (HBSAG) Assays to Test Blood *
02D-0096 Nucleic Acid Tests on Samples from Blood Donors to Reduce Ri *
02N-0062 New Dietary Ingredient Premarket Notification,Info. Collect *
02N-0115 Risk Management of Prescription Drugs; Public Hearing *
02P-0191 Request for immediate final approval of tramadol Hydrochlori *
02P-0247 ANDA Suitability for Clozapine 50 mg Tablets *
02P-0249 ANDA for 7.5 mg Mirtazapine Tablets *

77N-0085 Saccharin and Its Salts

CA 43724 Robert B Anderson Vol#: 677

CA 44199 Richard L Kaplan Vol#: 682

80N-0042 Anticaries Drug Products for OTC Human Use

LET 49 Consumer Healthcare Products Assn Vol#: 36

82N-0291 Vaginal Drug Products for OTC Human Use

PDN 1 HFC-1 to Purdue Frederick Company Vol#: 4

98P-0504 Raw Molluscan Shellfish of Undetectable Levels

EMC 196 Gary Young Vol#: 29

EMC 197 Noam Rettig Vol#: 29

EMC 198 Kimberly Akers Vol#: 29

EMC 199 Kimberly Akers Vol#: 29

EMC 200 Robert Swenson Vol#: 29

EMC 201 Gayle Speck Vol#: 29

EMC 202 Carol Moore Vol#: 29

EMC 203 Charlene Taub Vol#: 29

EMC 204 Jeff Grayson Vol#: 29

EMC 205 Keith Johns Vol#: 29

EMC 206 Hannah Burton Vol#: 29

EMC 207 Tova Kopperud Vol#: 29

EMC 208 Lawrence A. Krantz Vol#: 29

EMC 209 Barry Rabin Vol#: 29

EMC 210 Gail Hendrix Vol#: 29

EMC 211 Sandy Puretz Vol#: 29

EMC 212 Jeff Frontz Vol#: 29

EMC 213 Jeremy Schwartz Vol#: 29

EMC 214 Debbie Fletcher Vol#: 29

EMC 215 Madeline Rivera Vol#: 29

EMC 216 Thomas Michrina Vol#: 29

EMC 217 Thomas Michrina Vol#: 29

EMC 218 Abram Rutkowski Vol#: 29

EMC 219 James Corcoran Vol#: 29

EMC 220 DeeAnna Merz Vol#: 29

EMC 221 Kevin Larkin Amgioli Vol#: 29

98P-1121 Grated Parmesan Cheese Deviating from Identity standard

ANS 6 HFS-800 to Greenwood Valley Cheese Compa Vol#: 1

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

EMC 3617 Terrie Monti & Michael Bohdan Vol#: 511

EMC 3618 Terrie Monti & Michael Bohdan Vol#: 511

EMC 3619 Heidi Rupley Vol#: 511

EMC 3620 Katherine Treap Vol#: 511

EMC 3621 Donna Hoaglin Vol#: 511

EMC 3622 John Strouss Vol#: 511

EMC 3623 Curt Stewart Vol#: 511

EMC 3624 Jonathan Leiss Vol#: 511

EMC 3625 Annmarie Colbin Vol#: 511

EMC 3626 David Whitehouse Vol#: 511

EMC 3627 William B. Winget Vol#: 511

EMC 3628 Gretchen Wernersbach Vol#: 511

EMC 3629 Tom Pendleton Vol#: 511

EMC 3630 Christopher Newhouse Vol#: 511

EMC 3631 Anne Powers-Beck Vol#: 511

EMC 3632 Tony Conrad Vol#: 511

EMC 3633 Sandra Grant Vol#: 511

EMC 3634 Sandra Grant Vol#: 511

EMC 3635 Lisa Christopherson Vol#: 511

EMC 3636 Phyllis Berentsen Vol#: 511

EMC 3637 Jessica Evans Vol#: 511

EMC 3638 Daniel Dubnicka Vol#: 511

EMC 3639 Natasha & Noah Brenner Vol#: 511

EMC 3640 John C. Scott Vol#: 511

EMC 3641 Norma G. Hunt Vol#: 511

EMC 3642 R. Ruediger Vol#: 511

EMC 3643 Cynthia Carson Vol#: 511

EMC 3644 Meyer Scharlack Vol#: 511

EMC 3645 Martha Mickey Vol#: 511

EMC 3646 Shellie Willet Vol#: 511

EMC 3647 Edward Triska Vol#: 511

EMC 3648 Holly Owens Vol#: 511

EMC 3649 Heather Richman Vol#: 511

EMC 3650 Julie Spiegler Vol#: 511

EMC 3651 Kris Loman Vol#: 511

EMC 3652 Ujjala Marie Schwartz Vol#: 511

EMC 3653 Ann Fonfa Vol#: 511

EMC 3654 Arlene DiMarino Vol#: 511

EMC 3655 Arlene DiMarino Vol#: 511

EMC 3656 Carolyn Clark Vol#: 511

EMC 3657 Michelle Martin Vol#: 511

EMC 3658 Jessica Zern Vol#: 511

EMC 3659 Kathy Humiston Vol#: 511

EMC 3660 Kathy Humiston Vol#: 511

EMC 3661 Laura Keith Vol#: 511

99P-1340 Declared Eternity eau de Parfum Misbranded

EMC 375 Hatch Vol#: 21

EMC 376 Karen R. Wright Vol#: 21

EMC 377 Vicki S. Dickerson Vol#: 21

99P-4613 Revoke the Regulation That Approved Posilac

EMC 2413 Jodie4owen Vol#: 44

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9801 Form Letter Count 5 Vol#: 571

C 9802 Jennifer Walker Vol#: 570

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9365 Jennifer Walker Vol#: 408

C 9366 Margaret T. Korsak Vol#: 408

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

RMO 5 Bayer Corporation Vol#: 126

RMO 6 Animal Health Institute Vol#: 126

01D-0514 Guidance on Labeling of Reprocessed Single Use Devices

EMC 3 Will Garner Vol#: 1

01D-0577 Class II Special Controls Guidance Cutaneous Carbon Dioxide

EMC 2 Philips Medical Systems Vol#: 1

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

SET 1 GCF-1 & Worldwide Medical Corporation Vol#: 2

01N-0067 Reclassification of Dental Mercury

C 13 Sandra N. Duffy, J.D. Vol#: 3

EMC 53 Susan Finkus Vol#: 2

EMC 54 Linda M. Cifelli Vol#: 2

EMC 55 Frank Cuny Vol#: 2

EMC 56 Ms. Parvati Vol#: 2

EMC 57 Pedro & Anita Tibau Vol#: 2

EMC 58 Bernard Windham Vol#: 2

EMC 59 M.L. "Sam" Queen, MA, CCN, CNS, D.Sc Vol#: 2

EMC 60 Virginia Barber Vol#: 2

EMC 61 Jan S. McCoy Vol#: 2

EMC 62 Bobby McClintock Vol#: 2

EMC 63 Susan M. Suzuki Vol#: 2

EMC 64 Marlene MacFarlane Vol#: 2

EMC 65 Rene Fernandez, MD Vol#: 2

EMC 66 Guy M. & Doreen C. Randal Vol#: 2

EMC 67 Guy M. & Doreen C. Randal Vol#: 2

EMC 68 Sharon K. Donohue Vol#: 2

EMC 69 David G. Stahley Vol#: 2

EMC 70 Ralph Erickson Vol#: 2

EMC 71 Lorna Crosby Vol#: 2

EMC 72 Clinton Zimmerman Vol#: 2

EMC 73 Paul T. Culley Vol#: 2

EMC 74 Mary Ann Newell Vol#: 2

EMC 75 Lindell Tinsley Vol#: 2

EMC 76 Rosemary Fecteau, PhD Vol#: 2

EMC 77 Ralph Erickson Vol#: 2

EMC 78 Kathleen Harner Vol#: 2

EMC 79 Paul J. Funk Vol#: 2

EMC 80 Sheen Perkins Vol#: 2

EMC 81 Heather Gilbert Vol#: 2

EMC 82 Florence L. Saito Vol#: 2

EMC 83 Gina E. Jones Vol#: 2

EMC 84 Florence L. Saito Vol#: 2

EMC 85 Dr. Rita Holgers Vol#: 2

EMC 86 Vicki Vol#: 2

EMC 87 Vicki Kushner Vol#: 2

EMC 88 Jennifer Golarz Vol#: 2

EMC 89 Jennie McCann Vol#: 2

EMC 90 Gina Gunkel Vol#: 2

EMC 91 Barry Parnas Vol#: 2

EMC 92 Wayne L. Whitley, D.D.S. Vol#: 2

EMC 93 Mary Jo Griffin Vol#: 2

EMC 94 Dr. Janet Stopka Vol#: 2

EMC 95 Stuart Scheckner, DMD Vol#: 2

EMC 96 Mary Kraayenbrink Vol#: 2

EMC 97 Martin Rasmussen Vol#: 2

EMC 98 Arte L. Whyte Vol#: 2

EMC 99 Randi Kuhne Vol#: 2

EMC 100 Francesca Rago Vol#: 2

EMC 101 Dr. Nicholas Meyer Vol#: 2

EMC 102 Felix Liao Vol#: 2

EMC 103 Anne Ferreira Vol#: 2

EMC 104 M. Sean Vol#: 2

EMC 105 Joan Didak Vol#: 2

EMC 106 Marjorie Monteleon Vol#: 2

EMC 107 Marvin L. Van Haaften Vol#: 2

EMC 108 Carol J. Ward Vol#: 2

EMC 109 Steven M. Sala Vol#: 2

EMC 110 Gerald H. Smith Vol#: 2

EMC 111 Kayde Cadwell Vol#: 2

EMC 112 James W. Medlock, DDS Vol#: 2

EMC 113 Julianne O'Dwyer Vol#: 2

EMC 114 K. Ryan Biondo Vol#: 2

EMC 115 K. Ryan Biondo Vol#: 2

EMC 116 Jennifer Golarz Vol#: 2

EMC 117 Jennie McCann Vol#: 2

EMC 118 Linda K. Kelly Vol#: 2

EMC 119 Jean Griffin Vol#: 2

EMC 120 Sandra N. Duffy Vol#: 2

EMC 121 Carol Sterritt Vol#: 2

EMC 122 Martha Sonnenblick Vol#: 2

EMC 123 Stuart Scheckner, DMD Vol#: 2

EMC 124 Jack & Brenda Marett Vol#: 2

EMC 125 Stacy Meyn Vol#: 2

EMC 126 Alice Griffin Vol#: 2

EMC 127 Christy Diemond Vol#: 2

EMC 128 Jeffery J. Clark Vol#: 2

EMC 129 Per Dalen Vol#: 2

EMC 130 Ann Blackmore Vol#: 2

EMC 131 Debra Brimhall Vol#: 2

EMC 132 Elisabet Carlsson Vol#: 2

EMC 133 Carolyn Dohrewend Vol#: 2

EMC 134 Claudeya K. Wiseman Vol#: 2

EMC 135 Jon Murphy, MD Vol#: 2

EMC 136 Pat King Vol#: 2

EMC 137 Mary Ann Newell Vol#: 2

EMC 138 Koichi Imai, DDS, PhD Vol#: 2

EMC 139 Marietta C.H. Jarra Vol#: 2

EMC 140 Ralph Wilson Vol#: 2

EMC 141 Ralph Wilson Vol#: 2

EMC 142 Mary Carney Vol#: 2

EMC 143 McKenna & Cuneo, LLP Vol#: 2

EMC 144 Christine Ferreira Vol#: 2

EMC 145 Albert Garcia Vol#: 2

EMC 146 Jeff Bal Vol#: 2

EMC 147 Ernie Mezei Vol#: 2

EMC 148 Dr. Elizabeth Simpson Vol#: 2

EMC 149 Victoria Williams Vol#: 2

EMC 150 Consumers for Dental Choice, Inc. Vol#: 2

EMC 151 Joanie Misrack Vol#: 2

EMC 152 Joanie Misrack Vol#: 2

EMC 153 Barbara Christian Vol#: 2

EMC 154 Barbara Christian Vol#: 2

EMC 155 no signature Vol#: 2

EMC 156 no signature Vol#: 2

EMC 157 Joseph M. Sheehan Vol#: 2

EMC 158 Ralph Wilson, N.D. Vol#: 2

EMC 159 Ralph Wilson, N.D. Vol#: 2

01N-0078 Assessment of Physician & Patient Attitudes Toward Direct-to

EMC 10 Douglas L. Cook Vol#: 1

01N-0322 Institutional Review Boards

C 12 University of Iowa Vol#: 1

EMC 17 Rev. Richard Wolberg Vol#: 1

01N-0548 Guidelines for Voluntary Nutrition Labeling of Raw Fruits

C 2 California Avocado Commission Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 895 Laura Keith Vol#: 190

C 896 John Kunz Vol#: 190

C 897 Ren Bean Vol#: 190

C 898 Form letter count Vol#: 200

EMC 1966 Shari Wildschutte Vol#: 192

EMC 1967 Joyce Asfour Vol#: 192

EMC 1968 Reverend Charlene Zvolanek Vol#: 192

EMC 1969 Gretchen Hart Vol#: 192

01P-0345 Listing the color additive yellow #5 for use in food/Drug

EMC 1080 Peter Saunders Vol#: 5

EMC 1081 No signature Vol#: 5

EMC 1082 Christine & Bruce Hamilton Vol#: 5

EMC 1083 Marie F. Jones Vol#: 5

01P-0447 Withdrawn for Safety or Effectivess of Ardeparin Sodium

LET 2 HFD-7 to John W. Herr Vol#: 1

02D-0081 Hepatitis B Surface Antigen (HBSAG) Assays to Test Blood

EMC 1 American Assn of Blood Banks Vol#: 1

02D-0096 Nucleic Acid Tests on Samples from Blood Donors to Reduce Ri

EMC 1 American Assn of Blood Banks Vol#: 1

02N-0062 New Dietary Ingredient Premarket Notification,Info. Collect

EMC 1 Jarrow Formulas, Inc. Vol#: 1

02N-0115 Risk Management of Prescription Drugs; Public Hearing

EMC 3 Donna Guidry Vol#: 1

EMC 4 American Society of Consultant Pharmacis Vol#: 1

EMC 5 Alan S. Hollister, M.D., PhD Vol#: 1

02P-0191 Request for immediate final approval of tramadol Hydrochlori

EMC 2 Teva Pharmaceuticals USA Inc. Vol#: 1

02P-0247 ANDA Suitability for Clozapine 50 mg Tablets

ACK 1 HFA-305 Vol#: 1

CP 1 AAC Consulting Group Vol#: 1

02P-0249 ANDA for 7.5 mg Mirtazapine Tablets

ACK 1 HFA-305 Vol#: 1

CP 1 AAC Consulting Group Vol#: 1

02V-0248 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Princeton Alliance Church Vol#: 1