Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870; TTY/TDD Users 1-800-735-2258 - [E-mail Us]

DOCKETS ENTERED on 12/02/02

TABLE OF CONTENTS

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97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa *
00D-0053 Reprocessing&Reuse of Single-Use Devices/Risk Categorization *
00N-1571 Enrofloxacin for Poultry: Opportunity for hearing *
02D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate *
02N-0445 FDA Regulation of Combination Products; Public Hearing *
02N-0466 Safety, Clinical and Immune Response of Dryvax *

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

C 2270 Sue M. Win Vol#: 65

EMC 528 Ray Ann Sullivan Vol#: 65

97S-0162 30-Day Structure Function Claim Notification Letters Dietary

LET 9246 Jarrow Formulas, Inc Vol#: 70

LET 9247 Jarrow Formulas, Inc Vol#: 70

LET 9248 Jarrow Formulas, Inc Vol#: 70

LET 9249 Tabak's Health Products Vol#: 70

LET 9250 Jarrow Formulas, Inc Vol#: 70

LET 9251 Natural Organics Inc Vol#: 70

LET 9252 NBTY Inc Vol#: 70

LET 9253 NBTY Inc Vol#: 70

LET 9254 NBTY Inc Vol#: 70

LET 9255 NBTY Inc Vol#: 70

LET 9256 NBTY Inc Vol#: 70

LET 9257 NBTY Inc Vol#: 70

LET 9258 NBTY Inc Vol#: 70

LET 9259 NBTY Inc Vol#: 70

LET 9260 NBTY Inc Vol#: 70

LET 9261 NBTY Inc Vol#: 70

LET 9262 NBTY Inc Vol#: 70

LET 9263 NBTY Inc Vol#: 70

LET 9264 NBTY Inc Vol#: 70

LET 9265 NBTY Inc Vol#: 70

LET 9266 NBTY Inc Vol#: 70

LET 9267 Enzymatic Therapy Natural Medicines Vol#: 70

LET 9268 NBTY Inc Vol#: 70

LET 9269 NBTY Inc Vol#: 70

LET 9270 NBTY Inc Vol#: 70

LET 9271 PhytoPharmica Natural Medicines Vol#: 70

LET 9272 Enzymatic Therapy Natural Medicines Vol#: 70

LET 9273 NBTY Inc Vol#: 70

LET 9274 NBTY Inc Vol#: 70

LET 9275 NBTY Inc Vol#: 70

LET 9276 NBTY Inc Vol#: 70

LET 9277 NBTY Inc Vol#: 70

LET 9278 NBTY Inc Vol#: 70

LET 9279 NBTY Inc Vol#: 70

LET 9280 NBTY Inc Vol#: 70

LET 9281 NBTY Inc Vol#: 70

LET 9282 NBTY Inc Vol#: 70

LET 9283 Jarrow Formulas, Inc Vol#: 70

LET 9284 Iwade Research Institute of Mycology CLd Vol#: 70

LET 9285 Enzymatic Therapy Natural Medicines Vol#: 70

LET 9286 PhytoPharmica Natural Medicines Vol#: 70

LET 9287 PhytoPharmica Natural Medicines Vol#: 70

LET 9288 Enzymatic Therapy Natural Medicines Vol#: 70

LET 9289 Enzymatic Therapy Natural Medicines Vol#: 70

LET 9290 PhytoPharmica Natural Medicines Vol#: 70

LET 9291 PhytoPharmica Natural Medicines Vol#: 70

LET 9292 Enzymatic Therapy Natural Medicines Vol#: 70

LET 9293 Solstice Medicine Company Vol#: 70

LET 9294 Perrigo Company of South Carolina Vol#: 70

LET 9295 Perrigo Company of South Carolina Vol#: 70

LET 9296 Twin Laboratories Inc Vol#: 70

LET 9297 Twin Laboratories Inc Vol#: 70

LET 9298 Twin Laboratories Inc Vol#: 70

LET 9299 Perrigo Company of South Carolina Vol#: 70

LET 9300 tehall-Robins Healthcare, Div of AHPC Vol#: 70

LET 9301 NBTY Inc Vol#: 70

LET 9302 NBTY Inc Vol#: 70

LET 9303 NBTY Inc Vol#: 70

LET 9304 NBTY Inc Vol#: 70

LET 9305 NBTY Inc Vol#: 70

LET 9306 NBTY Inc Vol#: 70

LET 9307 NBTY Inc Vol#: 70

LET 9308 NBTY Inc Vol#: 70

LET 9309 NBTY Inc Vol#: 70

LET 9310 NBTY Inc Vol#: 70

LET 9311 NBTY Inc Vol#: 70

LET 9312 NBTY Inc Vol#: 70

LET 9313 NBTY Inc Vol#: 70

LET 9314 NBTY Inc Vol#: 70

LET 9315 NBTY Inc Vol#: 70

LET 9316 NBTY Inc Vol#: 70

LET 9317 NBTY Inc Vol#: 70

LET 9318 NBTY Inc Vol#: 70

LET 9319 NBTY Inc Vol#: 70

LET 9320 NBTY Inc Vol#: 70

LET 9321 NBTY Inc Vol#: 70

LET 9322 NBTY Inc Vol#: 70

LET 9323 NBTY Inc Vol#: 70

LET 9324 NBTY Inc Vol#: 70

LET 9325 Unither Pharmaceuticals Inc. Vol#: 70

LET 9326 Country Life Vol#: 70

LET 9327 Denman Scientific Research Vol#: 70

LET 9328 Serotril Sciences, International Vol#: 70

LET 9329 Bentley Myers International Co Vol#: 70

LET 9330 Perrigo Company of South Carolina Vol#: 70

LET 9331 Mannatech Incorporated Vol#: 70

LET 9332 RKS Inc. Vol#: 70

LET 9333 Denman Scientific Research Vol#: 70

LET 9334 Market America, Inc. Vol#: 70

LET 9335 Bentley Myers International Co Vol#: 70

LET 9336 Serotril Sciences, International Vol#: 70

98D-1146 Microbial effects of antimicrobial new animal drugs/human sa

C 76 National Pork Producers Council Vol#: 2

EMC 662 Denise Banker Vol#: 15

00D-0053 Reprocessing&Reuse of Single-Use Devices/Risk Categorization

C 42 Association of the Nonwoven Fabrics Indu Vol#: 5

00D-1598 Voluntary Labeling for Bioengineered Foods

EMC 11875 Beth MacFawn Vol#: 570

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

MO 20 Bayer Corporation Vol#: 329

MO 21 Bayer Corporation Vol#: 329

RMO 12 Center for Veterinary Medicine Vol#: 329

01N-0339 Medical Washer & Medical Washer-Disinfector

NFR 1 Vol#: 1

02D-0324 Bioengineered Plants for Use in Humans and Animals

C 49 Michele M. Wuensch Vol#: 1

C 50 Dorthy Compinsky Vol#: 1

02D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate

C 12 Sisters of the Holy Cross Congregation Vol#: 1

02D-0467 Blood products safety cases known/suspected West Nile Virus

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

02N-0280 Objections & Request for a Hearing on a Regulation or Order

N 2 Vol#: 1

02N-0445 FDA Regulation of Combination Products; Public Hearing

LET 1 Hyman, Phelps & McNamara, PC Vol#: 4

02N-0466 Safety, Clinical and Immune Response of Dryvax

C 9 Tonya Miller Vol#: 1

C 10 Lindsay Goss Vol#: 1

C 11 Emily McCann Vol#: 1

C 12 Lauren Henderson Vol#: 1

C 13 Aliance for Human Research Protection Vol#: 1

C 14 Alicia Vignola Vol#: 1

C 15 Julian Fairchild Vol#: 1

C 16 M. Sohcot Vol#: 1

C 17 Matt Rucinski Vol#: 1

C 18 Jay Friedman Vol#: 1

C 19 Jenna Elliot Vol#: 1

C 20 Kerrigan Murphy Vol#: 1

C 21 Jerome Harris Vol#: 1

C 22 Jessica I. London Vol#: 1

C 23 Vaiva Gelazauskas Vol#: 1

C 24 Maurice Samuel Vol#: 1

C 25 Matt Tarrant Vol#: 1

C 26 Jeremy Anderson Vol#: 1

C 27 No signature Vol#: 1

EMC 95 Nan Vol#: 1

EMC 96 David & Bobbi Scogin Vol#: 1

EMC 97 Laura Mullaly Vol#: 1

EMC 98 Carol Martin Vol#: 1

EMC 99 Linda Schmidt Vol#: 1

EMC 100 Deborah Eubanks Vol#: 1

EMC 101 Ed Johnson Vol#: 1

EMC 102 David Peterson Vol#: 1

EMC 103 Therese Caveney Vol#: 1

EMC 104 Retta Knott Vol#: 1

EMC 105 Susan Pearce Vol#: 1

EMC 106 No signature Vol#: 1

EMC 107 Teresa Conrick Vol#: 1

EMC 108 Mary Hirzel Vol#: 1

EMC 109 Mary McDonald Vol#: 1

EMC 110 No signature Vol#: 1

EMC 111 Amanda Hertz-Crisel Vol#: 1

EMC 112 Dana Wisdom Vol#: 1

EMC 113 Rick Ensminger Vol#: 1

EMC 114 Mannaharts International Vol#: 1

EMC 115 Myron A. Vedvik Vol#: 1

EMC 116 Boston University School of Public Healt Vol#: 1

EMC 117 Geri Hehls Vol#: 1

EMC 118 Consumers Health Freedom Coalition Vol#: 1

EMC 119 Cynthia Hayes Vol#: 1

EMC 120 University of Minnesota Vol#: 1

EMC 121 No signature Vol#: 1

EMC 122 Ginny Longtin Vol#: 1

EMC 123 No signature Vol#: 1

EMC 124 Jay Einhorn Vol#: 1

EMC 125 Sue Graham Vol#: 1

EMC 126 Robert Cilburn Vol#: 1

EMC 127 Boston University School of Public Healt Vol#: 1

EMC 128 Kristie Richardson Vol#: 1

EMC 129 Rene LeMay Vol#: 1

EMC 130 Sheri Nakken, RN, MA Vol#: 1

EMC 131 No signature Vol#: 1

EMC 132 Wisteria Haines Vol#: 1

EMC 133 No signature Vol#: 1

EMC 134 Richard Charlton Vol#: 1

EMC 135 Barbara Campbell Vol#: 1

EMC 136 Marguerite King Vol#: 1

EMC 137 John Draper Vol#: 1

EMC 138 Sharon Bafetti Vol#: 1

EMC 139 Pamela Loffredo Vol#: 1

EMC 140 Kelli Matheny Vol#: 1

EMC 141 No signature Vol#: 1

EMC 142 No signature Vol#: 1

EMC 143 Pat Dutkiewicz Vol#: 1

EMC 144 Ann Watts Vol#: 1

EMC 145 No signature Vol#: 1

EMC 146 No signature Vol#: 1

EMC 147 Jeff Crawford Vol#: 1

EMC 148 Tia Acosta Vol#: 1

EMC 149 Lori Copeland Vol#: 1

EMC 150 Angie Young Vol#: 1

EMC 151 Jan Wilkes Vol#: 1

EMC 152 Sandi Mazza Vol#: 1

EMC 153 Rita Shreffler Vol#: 1

EMC 154 Valentina Scharpf Vol#: 1

EMC 155 No signature Vol#: 1

EMC 156 No signature Vol#: 1

EMC 157 Jennifer Vol#: 1

EMC 158 Shelly Reynolds Vol#: 1

EMC 159 Cindy Stolten Vol#: 1

EMC 160 Sharyn Cerniglia Vol#: 1

EMC 161 Rebecca Sytsema Vol#: 1

EMC 162 Oscar S. & Donna J. Carver Vol#: 1

EMC 163 Mr & Mrs Emmett Dykes Vol#: 1

EMC 164 Chandramathi Vemuri Vol#: 1

EMC 165 Aliance for Human Research Protection Vol#: 1

EMC 166 Beth Morti Vol#: 1

EMC 167 Debbie Milligan Vol#: 1

EMC 168 Barbara Powell Vol#: 1

EMC 169 Mary Brookhart Vol#: 1

EMC 170 Judy K. Prainito Vol#: 1

EMC 171 Marion Weis Vol#: 1

EMC 172 Onsted Dianne Vol#: 1

EMC 173 LaDonna Sasscer Vol#: 1

EMC 174 Penny Ray Vol#: 1

EMC 175 Richard G. Shuster Vol#: 1

EMC 176 Mark Hovila Vol#: 1

EMC 177 Elizabeth Buege Vol#: 1

EMC 178 Paula Rucker Vol#: 1

EMC 179 Paula Rucker Vol#: 1

EMC 180 Howard & Diana Carter Vol#: 1

EMC 181 Jim Ferber Vol#: 1

EMC 182 Jill Goldsmith Vol#: 1

EMC 183 Karen Grupe Vol#: 1

EMC 184 Lorraine Rhodes Vol#: 1

EMC 185 Kathleen Sheehy Vol#: 1

EMC 186 John R. & Mary Ellen Cave Vol#: 1

EMC 187 Michele Coffey Vol#: 1

EMC 188 Bethanne Schrecengost Vol#: 1

EMC 189 Brant Neal Vol#: 1

EMC 190 No signature Vol#: 1

EMC 191 Herb Rose Vol#: 1

EMC 192 Tracy Money Vol#: 1

EMC 193 Melissa McNeese Vol#: 1

EMC 194 Mary Wetherby Vol#: 1

EMC 195 Kevin McMorrow Vol#: 1

EMC 196 K. Yvonne Goldsmith Vol#: 1

EMC 197 L. Teasdale Vol#: 1

EMC 198 Barbara Russell Vol#: 1

EMC 199 Kristan Buege-Miller Vol#: 1

EMC 200 Children's Advocacy Network Vol#: 1

EMC 201 James Roth Vol#: 1

EMC 202 Ron Flammia Vol#: 1

EMC 203 Dawna Marvel Vol#: 1

EMC 204 Dave Godin Vol#: 1

EMC 205 Mary Cutler Vol#: 1

EMC 206 George C. Jeffrey Vol#: 1

EMC 207 Beverly Teague Vol#: 1

EMC 208 Amy Kidd Vol#: 1

EMC 209 Kim Nerswick Vol#: 1

EMC 210 Georgia Brown Vol#: 1

EMC 211 Erin Ross Vol#: 1

EMC 212 No signature Vol#: 1

EMC 213 Shawn Laird Vol#: 1

EMC 214 No signature Vol#: 1

EMC 215 Sandra van Nuland Vol#: 1

EMC 216 Patti Gamble Vol#: 1

EMC 217 No signature Vol#: 1

EMC 218 LD Wedewer Vol#: 1

EMC 219 Allison Buege Watson Vol#: 1

EMC 220 Keith & Gail Brightbill Vol#: 1

02P-0317 Recall Aspartame as a Neurotoxic Drug

EMC 68 Peter Doyle Vol#: 1

EMC 69 No signature Vol#: 1