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 November 6, 2001

TABLE OF CONTENTS

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97P-0130 Require Percentage Ingredient Labeling *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
00P-1297 Permit an OTC drug mfg to include "may contain" in label *
01P-0230 Domestic Marketing & Importation of Transgenic Fish *
01P-0320 Establish Format Standards for Ingredient Labels on Food Pro *
77N-0085 Saccharin and Its Salts

CA 13913 Elizabeth Smoyer Vol#: 366

97P-0130 Require Percentage Ingredient Labeling

C 131 Elizabeth Lytle Isaac Vol#: 5

C 132 Robin Kaiser Vol#: 5

C 133 Cherri Brown Vol#: 5

C 134 Pat Vol#: 5

C 135 Judy Gelfand Vol#: 5

C 136 Mouicha Vol#: 5

C 137 K. Mackaye Vol#: 5

C 138 M. C. S. Vol#: 5

C 139 Kathy L. Roberts Vol#: 5

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

LET 8172 Neways, Inc. Vol#: 61

LET 8173 Neways, Inc. Vol#: 61

LET 8174 Michael's Naturopathic Programs Vol#: 61

LET 8175 Michael's Naturopathic Programs Vol#: 61

LET 8176 Michael's Naturopathic Programs Vol#: 61

LET 8177 Michael's Naturopathic Programs Vol#: 61

LET 8178 Michael's Naturopathic Programs Vol#: 61

LET 8179 Michael's Naturopathic Programs Vol#: 61

LET 8180 Michael's Naturopathic Programs Vol#: 61

LET 8181 Michael's Naturopathic Programs Vol#: 61

LET 8182 Michael's Naturopathic Programs Vol#: 61

LET 8183 Michael's Naturopathic Programs Vol#: 61

LET 8184 Michael's Naturopathic Programs Vol#: 61

LET 8185 Michael's Naturopathic Programs Vol#: 61

LET 8186 Michael's Naturopathic Programs Vol#: 61

LET 8187 Michael's Naturopathic Programs Vol#: 61

LET 8188 Michael's Naturopathic Programs Vol#: 61

LET 8189 Michael's Naturopathic Programs Vol#: 61

LET 8190 Michael's Naturopathic Programs Vol#: 61

LET 8191 Michael's Naturopathic Programs Vol#: 61

LET 8192 Michael's Naturopathic Programs Vol#: 61

LET 8193 Michael's Naturopathic Programs Vol#: 61

LET 8194 Michael's Naturopathic Programs Vol#: 61

LET 8195 Michael's Naturopathic Programs Vol#: 61

LET 8196 Michael's Naturopathic Programs Vol#: 61

LET 8197 Michael's Naturopathic Programs Vol#: 61

LET 8198 Michael's Naturopathic Programs Vol#: 61

LET 8199 Michael's Naturopathic Programs Vol#: 61

LET 8200 Michael's Naturopathic Programs Vol#: 61

LET 8201 Michael's Naturopathic Programs Vol#: 61

LET 8202 Michael's Naturopathic Programs Vol#: 61

LET 8203 Michael's Naturopathic Programs Vol#: 61

LET 8204 Michael's Naturopathic Programs Vol#: 61

LET 8205 Michael's Naturopathic Programs Vol#: 61

LET 8206 Michael's Naturopathic Programs Vol#: 61

LET 8207 Michael's Naturopathic Programs Vol#: 61

LET 8208 Michael's Naturopathic Programs Vol#: 61

LET 8209 Michael's Naturopathic Programs Vol#: 61

LET 8210 Michael's Naturopathic Programs Vol#: 61

LET 8211 Michael's Naturopathic Programs Vol#: 61

LET 8212 Michael's Naturopathic Programs Vol#: 61

LET 8213 Michael's Naturopathic Programs Vol#: 61

LET 8214 Michael's Naturopathic Programs Vol#: 61

LET 8215 Michael's Naturopathic Programs Vol#: 61

LET 8216 Michael's Naturopathic Programs Vol#: 61

LET 8217 Michael's Naturopathic Programs Vol#: 61

LET 8218 Natural Organics Inc Vol#: 61

LET 8219 Young Living Essentials Oils Vol#: 61

LET 8220 Solvay Vitamin & Herb Vol#: 61

LET 8221 Solvay Vitamin & Herb Vol#: 61

LET 8222 Natural Organics Inc Vol#: 61

LET 8223 Collagenex Pharmaceuticals Vol#: 61

LET 8224 Perrigo Company of South Carolina Vol#: 61

LET 8225 Bayer Corporation Vol#: 61

LET 8226 Hansen Beverage Company Vol#: 61

LET 8227 Hansen Beverage Company Vol#: 61

LET 8228 Hansen Beverage Company Vol#: 61

LET 8229 Hansen Beverage Company Vol#: 61

LET 8230 Jarrow Formulas Inc Vol#: 61

LET 8231 Jarrow Formulas Inc Vol#: 61

LET 8232 Jarrow Formulas Inc Vol#: 61

LET 8233 Whitehall Robins Healthcare Vol#: 61

LET 8234 Bee-Alive Inc Vol#: 61

LET 8235 Bee-Alive Inc Vol#: 61

LET 8236 Bee-Alive Inc Vol#: 61

LET 8237 Lichtwer Pharma US Inc Vol#: 61

LET 8238 Eniva Corporation Vol#: 61

LET 8239 Eniva Corporation Vol#: 61

LET 8240 Eniva Corporation Vol#: 61

LET 8241 Eniva Corporation Vol#: 61

LET 8242 Eniva Corporation Vol#: 61

LET 8243 Eniva Corporation Vol#: 61

LET 8244 Eniva Corporation Vol#: 61

LET 8245 Eniva Corporation Vol#: 61

LET 8246 Perrigo Company of South Carolina Vol#: 61

LET 8247 Twin Laboratories Inc Vol#: 61

LET 8248 Twin Laboratories Inc Vol#: 61

LET 8249 Twin Laboratories Inc Vol#: 61

LET 8250 Golden Pride Inc Vol#: 61

LET 8251 Premier Research Labs Vol#: 61

LET 8252 Twin Laboratories Inc Vol#: 61

LET 8253 Country Life Vol#: 61

LET 8254 J R Carlson Laboraotires Inc Vol#: 61

LET 8255 J R Carlson Laboraotires Inc Vol#: 61

LET 8256 J R Carlson Laboraotires Inc Vol#: 61

LET 8257 J R Carlson Laboraotires Inc Vol#: 61

LET 8258 J R Carlson Laboraotires Inc Vol#: 61

LET 8259 J R Carlson Laboraotires Inc Vol#: 61

LET 8260 J R Carlson Laboraotires Inc Vol#: 61

LET 8261 J R Carlson Laboraotires Inc Vol#: 61

LET 8262 J R Carlson Laboraotires Inc Vol#: 61

LET 8263 Mason Vitamins Inc Vol#: 61

LET 8264 Mason Vitamins Inc Vol#: 61

LET 8265 Mason Vitamins Inc Vol#: 61

LET 8266 Mason Vitamins Inc Vol#: 61

LET 8267 Mason Vitamins Inc Vol#: 61

LET 8268 Mason Vitamins Inc Vol#: 61

LET 8269 Mason Vitamins Inc Vol#: 61

LET 8270 Mason Vitamins Inc Vol#: 61

LET 8271 Mason Vitamins Inc Vol#: 61

LET 8272 Mason Vitamins Inc Vol#: 61

LET 8273 Mason Vitamins Inc Vol#: 61

LET 8274 Mason Vitamins Inc Vol#: 61

LET 8275 Mason Vitamins Inc Vol#: 61

LET 8276 Country Life Vol#: 61

LET 8277 Twin Laboratories Inc Vol#: 61

LET 8278 Perrigo Company of South Carolina Vol#: 61

LET 8279 Hansen's Beverage Company Vol#: 61

LET 8280 Perrigo Company of South Carolina Vol#: 61

LET 8281 Planetary Formulas Vol#: 61

LET 8282 Aboca USA Vol#: 61

LET 8283 Aboca USA Vol#: 61

LET 8284 Aboca USA Vol#: 61

LET 8285 Aboca USA Vol#: 61

LET 8286 Aboca USA Vol#: 61

LET 8287 Aboca USA Vol#: 61

LET 8288 Aboca USA Vol#: 61

LET 8289 Snapple Beverage Group Vol#: 61

LET 8290 Natural Organics Inc Vol#: 61

LET 8291 Natural Organics Inc Vol#: 61

LET 8292 Natural Organics Inc Vol#: 61

LET 8293 NBTY Inc Vol#: 61

LET 8294 NBTY Inc Vol#: 61

98N-0337 Over the counter human drugs labeling requirements

ANS 11 HFD-560 to L Perrigo Company Vol#: 8

00P-1297 Permit an OTC drug mfg to include "may contain" in label

PAV 1 HFC-1 to Arnall Golden & Gregory, LLP Vol#: 1

PAV 2 HFC-1 to Consumer Healthcare Products As Vol#: 1

01D-0432 Evalution of the effects of Orally Inhaled and Intranasal

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

01N-0336 Withdrawal of 51 NDAs and 25 ANDAs

NCR 1 Vol#: 1

01N-0494 Inhalational Anthrax (Post-Exposure) Doxycycline/PenicillinG

N 1 Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

EMC 1089 Alice Schneider Vol#: 49

EMC 1090 Emma McGregor-Mento Vol#: 49

EMC 1091 Anahata Pomeroy Vol#: 49

EMC 1092 Dave Sherman Vol#: 49

EMC 1093 Clare Cleveland Vol#: 49

EMC 1094 Jack Cleveland Vol#: 49

EMC 1095 Cheryl H. Williams Vol#: 49

EMC 1096 Frances Renaud Vol#: 49

EMC 1097 Walter Martin Vol#: 49

EMC 1098 Clifford Long Vol#: 49

EMC 1099 Rhea Irvine Vol#: 49

EMC 1100 Cathryn Carlson Vol#: 49

EMC 1101 Scott Silverman Vol#: 49

EMC 1102 Lloyd Goodwon Vol#: 49

EMC 1103 Mary Ho Vol#: 49

EMC 1104 Douglas Van Fleet Vol#: 49

EMC 1105 Annabelle Bosset Vol#: 49

EMC 1106 Mary E. Stone Vol#: 49

EMC 1107 Paul Rosenblatt Vol#: 49

EMC 1108 Janet Hu Vol#: 49

EMC 1109 Constantine Faller Vol#: 49

EMC 1110 Fred Jakobcic Vol#: 49

EMC 1111 Larry Snyder Vol#: 49

EMC 1112 Victoria Ciulla Vol#: 49

EMC 1113 Cheryl Beckett Vol#: 49

EMC 1114 Margaret Meyer Vol#: 49

EMC 1115 Anne C. Story Vol#: 49

EMC 1116 Tiffany Catalfano Vol#: 49

EMC 1117 Cassandra Cramer Vol#: 49

EMC 1118 Merilee Eddy Vol#: 49

EMC 1119 Hilary Forrest Vol#: 49

EMC 1120 John Baumgartner Vol#: 49

EMC 1121 Maria Welch Vol#: 49

EMC 1122 Jennifer Pitino Vol#: 49

EMC 1123 Roberta Smith Vol#: 49

EMC 1124 Ani Karetka Vol#: 49

EMC 1125 Jason Steffensen Vol#: 49

EMC 1126 Hugh Eckert Vol#: 49

EMC 1127 Jean Maier Vol#: 49

EMC 1128 Monica Steensma Vol#: 49

EMC 1129 Marcy Bloomenthal Vol#: 49

EMC 1130 Robert George Vol#: 49

EMC 1131 Christine Word Vol#: 49

EMC 1132 Felicia Foti Vol#: 49

EMC 1133 Genevieve Vierling Vol#: 49

EMC 1134 John Pielaszczyk Vol#: 49

EMC 1135 Robert Sutton Vol#: 49

EMC 1136 Janine Kwasnik Vol#: 49

EMC 1137 number not used Vol#: 49

EMC 1138 Mr. Dante Joseph Vol#: 49

EMC 1139 Taylor Chamberlain Vol#: 49

EMC 1140 Susan Tucker Vol#: 49

EMC 1141 Rebecca Minifie Vol#: 49

EMC 1142 Hilder Mock Vol#: 49

EMC 1143 Helen Kintner Vol#: 49

01P-0320 Establish Format Standards for Ingredient Labels on Food Pro

C 93 Mr. David Zeff Vol#: 5

C 94 Mr. & Mrs. W. A. Siegmann Vol#: 5

C 95 Eleanor G. Abell Vol#: 5

C 96 Gary & Dottie Savage Vol#: 5

C 97 Glenn D.Littenberg, M.D. Vol#: 5

C 98 Graham R. Susan L. Schatz Vol#: 5

C 99 Anne Zink Vol#: 5

C 100 E. T. Gholson Vol#: 5

C 101 Reed N. Bement Vol#: 5

C 102 Norma Zeff Vol#: 5

C 103 Sandra Fedorovich Vol#: 5

C 104 Jacquelyn Stearns Vol#: 5

C 105 E. Porter Vol#: 5

C 106 Mrs. Maryan Oakley Vol#: 5

C 107 John H. Doughty Vol#: 5

C 108 Mrs. Marguerite Rogers Vol#: 5

C 109 Mary J. Gillespie Vol#: 5