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DOCKETS ENTERED on August 1, 2002

TABLE OF CONTENTS

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95N-0308 Inapplicability of the Dietary Supplement Health & Ed. Act t *
98F-0052 Amended to provide for the safe use of Phenylanlanine. *
00N-1652 Human Prescripton Drugs/Bilogics in Electronic Format *
01D-0435 International Conference on Harmonisation *
01P-0396 Request that FDA ban the production and sale of all ephedra *
01P-0572 Petition for Regulation of Ariva Tobacco Lozenges *
02D-0231 Stability Data Pack for Registration Climatic Zones lll & IV *
02D-0232 S7B Pharmacology Studies re:Potential Delayed Ventricular Re *
02D-0237 QIE Evaluation of Stability Data *
02N-0204 Bar Code Label Requirements for human drug products *
02N-0209 Governing First Amendment Case Law *
02N-0276 Bioterrorism Preparedness;Registration of Food Facilities *
02N-0278 Bioterrorism Preparedness;Pior Notice of Imported Food Shipm *
02P-0075 Flavored Candy-like Products Containing Tobacco *
02P-0135 Orally-Administered Levothyroxine Sodium all NDAs & ANDAs *
02P-0346 ANDA Amiodarone Hydrochloride Injection 450mg/9ml single use *

80N-0042 Anticaries Drug Products for OTC Human Use

EMC 1 Domenick T. Zero, DDS, MS Vol#: 36

EMC 2 C. Dean Germano Vol#: 36

82N-0269 WHEAT GLUTEN, CORN GLUTEN & ZEIN GRAS STATUS

EMC 1 Dawn Snyder Vol#: 1

94D-0401 Bioequivalence Guideline Draft

EMC 1 Bert Meijer Vol#: 1

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

EMC 523 John DeFlore Vol#: 65

95N-0308 Inapplicability of the Dietary Supplement Health & Ed. Act t

C 304 Janelle M. Krusper Vol#: 12

C 305 Elaine & Linda Den Braber Vol#: 12

C 306 Susan M. Barrett Vol#: 12

C 307 American Dog Owers Assn., Inc. Vol#: 12

C 308 Thomas Szczepaniak Vol#: 12

C 309 Susan M. Fraprie Vol#: 12

C 310 Patricia Keilholtz Vol#: 12

C 311 Laurie Dempsey Vol#: 12

C 312 Monte Dalton Vol#: 12

C 313 Georgiana Srachta Vol#: 12

C 314 Linda Grafe Vol#: 12

C 315 Denise Adler Vol#: 12

C 316 Marlene Dempsey Vol#: 12

C 317 Kent W. Wetherhold Vol#: 12

C 318 Beverly & Russell Hockenbury Vol#: 12

C 319 Brenda Randall & Family Vol#: 12

C 320 Patrice Cataldo Vol#: 12

C 321 Mary Lynn Szczepaniak Vol#: 12

C 322 Susan Romolo Vol#: 12

C 323 Susan Severance Vol#: 12

C 324 Laurel Whitney Moulton Vol#: 12

C 325 Earl & Gwen Chaney Vol#: 12

C 326 Pamela A. Logan Vol#: 12

C 327 Linda S. Hill Vol#: 12

C 328 Frances W. Muir Vol#: 12

C 329 Philip A. Leone Vol#: 12

C 330 Josephine F. Leone Vol#: 12

98F-0052 Amended to provide for the safe use of Phenylanlanine.

HER 1 Mission Possible International Vol#: 5

HER 2 Mission Possible International Vol#: 5

99F-0187 Neotame - Filing of Food Additive Petition (FAP 9A4643)

HER 1 Mission Possible International Vol#: 3

HER 2 Mission Possible International Vol#: 3

99F-4372 National Fisheries Institute and the Louisiana Dep of Agricu

EMC 298 Helen Desai Vol#: 5

EMC 299 Cheryl Deane Vol#: 5

EMC 300 Ellen Jantzen Vol#: 5

EMC 301 Valerie Sarver Vol#: 5

EMC 302 Michele Briggs Vol#: 5

EMC 303 Thomas Fisher Vol#: 5

EMC 304 Jeremy Furtner Vol#: 5

EMC 305 Kathy Gardner Vol#: 5

99F-5321 Food Safety & Inspection service safe use of ionizing radiai

EMC 201 Helen Desai Vol#: 5

EMC 202 Cheryl Deane Vol#: 5

EMC 203 Ellen Jantzen Vol#: 5

EMC 204 Valerie Sarver Vol#: 5

EMC 205 Michele Briggs Vol#: 5

EMC 206 Thomas Fisher Vol#: 5

EMC 207 Jeremy Furtner Vol#: 5

EMC 208 Kathy Gardner Vol#: 5

99F-5322 Ionizing Radiation for the Treatment of Food

EMC 200 Helen Desai Vol#: 4

EMC 201 Cheryl Deane Vol#: 4

EMC 202 Ellen Jantzen Vol#: 4

EMC 203 Valerie Sarver Vol#: 4

EMC 204 Michele Briggs Vol#: 4

EMC 205 Thomas Fisher Vol#: 4

EMC 206 Jeremy Furtner Vol#: 4

EMC 207 Kathy Gardner Vol#: 4

99F-5522 Ionizing radiation /control of Food-borne pathogens safe use

EMC 203 Helen Desai Vol#: 4

EMC 204 Cheryl Deane Vol#: 4

EMC 205 Ellen Jantzen Vol#: 4

EMC 206 Valerie Sarver Vol#: 4

EMC 207 Michele Briggs Vol#: 4

EMC 208 Thomas Fisher Vol#: 4

EMC 209 Jeremy Furtner Vol#: 4

EMC 210 Kathy Gardner Vol#: 4

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

EMC 3671 Helen Desai Vol#: 512

EMC 3672 Rich Yurman Vol#: 512

EMC 3673 Iris Kerman Vol#: 512

EMC 3674 Valerie Sarver Vol#: 512

EMC 3675 Michele Briggs Vol#: 512

EMC 3676 Janice L. Childers-Swartz Vol#: 512

00N-1652 Human Prescripton Drugs/Bilogics in Electronic Format

C 2 Merck & Co., Inc. Vol#: 1

C 3 PhRMA, Pharmaceutical Res. & Mfrs. of Am Vol#: 1

C 4 Eli Lilly and Company Vol#: 1

C 5 Baxter Healthcare Corporation Vol#: 1

01D-0435 International Conference on Harmonisation

C 6 Bristol-Myers Squibb Pharm. Res. Institu Vol#: 1

C 7 Liquent, Inc. Vol#: 1

C 8 PhRMA, Pharmaceutical Res. & Mfrs. of Am Vol#: 1

01F-0047 Foodborne pathogens in raw-frozen-cooked-partially cooked

EMC 300 Helen Desai Vol#: 6

EMC 301 Cheryl Deane Vol#: 6

EMC 302 Ellen Jantzen Vol#: 6

EMC 303 Valerie Sarver Vol#: 6

EMC 304 Michele Briggs Vol#: 6

EMC 305 Thomas Fisher Vol#: 6

EMC 306 Jeremy Furtner Vol#: 6

EMC 307 Kathy Gardner Vol#: 6

EMC 308 Adriana Leiva Vol#: 6

EMC 309 number not used Vol#: 6

EMC 310 Melissa Wayne Vol#: 6

EMC 311 Eva Arriaga Vol#: 6

EMC 312 Laurel Watson Vol#: 6

EMC 313 Claudio Mc Conell Vol#: 6

EMC 314 Stephanie Regan Vol#: 6

EMC 315 number not used Vol#: 6

EMC 316 Claire Lewis Vol#: 6

01P-0396 Request that FDA ban the production and sale of all ephedra

LET 1 Office of the Secretary,HHS Vol#: 1

01P-0572 Petition for Regulation of Ariva Tobacco Lozenges

RC 2 Star Scientific, Inc. Vol#: 2

02D-0231 Stability Data Pack for Registration Climatic Zones lll & IV

C 2 PhRMA Vol#: 1

02D-0232 S7B Pharmacology Studies re:Potential Delayed Ventricular Re

C 4 Bristol-Myers Squibb Pharm. Res. Institu Vol#: 1

02D-0237 QIE Evaluation of Stability Data

C 3 PhRMA Vol#: 1

02E-0339 Benicar, U.S. Patent No. 5,616,599

APP 1 Sankyo Company Vol#: 1

LET 1 U.S. Patent & Trademark Office Vol#: 1

M 1 HFD-7 Vol#: 1

02E-0340 Antagon, U.S. Patent No. 4,801,577

APP 1 Syntex (U.S.A.) Inc. Vol#: 1

LET 1 U.S. Patent & Trademark Office Vol#: 1

M 1 HFD-7 Vol#: 1

02E-0341 Fel-O-Vax FIV Vaccine, U.S. Patent No. 5,275,813

APP 1 The Reagent of the University of CA Vol#: 1

LET 1 U.S. Patent & Trademark Office Vol#: 1

M 1 HFD-7 Vol#: 1

02E-0343 Patent Term Application for Zevalin No. 5,776,456

APP 1 Claudia Grillo Vol#: 1

LET 1 Claudia Grillo Vol#: 1

M 1 Claudia Grillo Vol#: 1

02E-0344 Patent Term Application for ATS Open Pivot Bileaf Valve 5,35

APP 1 Claudia Grillo Vol#: 1

LET 1 Claudia Grillo Vol#: 1

M 1 Claudia Grillo Vol#: 1

02E-0345 Patent Term Application for Aromanis No. 4,808,616

APP 1 Claudia Grillo Vol#: 1

LET 1 Claudia Grillo Vol#: 1

M 1 Claudia Grillo Vol#: 1

02N-0204 Bar Code Label Requirements for human drug products

EMC 23 Consumer Healthcare Products Assn (CPHA) Vol#: 2

EMC 24 Healthcare Compliance Packaging Council Vol#: 2

EMC 25 Number not Used Vol#: 2

EMC 26 Healthcare Distribution Management Assn Vol#: 2

02N-0209 Governing First Amendment Case Law

EC 250 Mr. Norman Phillips Vol#: 4

EC 251 Mannatech Vol#: 4

EC 252 Mrs. Helen James Vol#: 4

EC 253 Mr. VICTOR G Pierson Vol#: 4

EC 254 Nick's Sales and Service Vol#: 4

EC 255 Ms. Judy Johnson Vol#: 4

EC 256 Mannatech Vol#: 4

EC 257 Number Not Used Vol#: 4

EC 258 Number Not Used Vol#: 4

EC 259 Number Not Used Vol#: 4

EC 260 Mr. craig weible Vol#: 4

EC 261 Mrs. Lynda Wallin Vol#: 4

EC 262 Mr. Reed Hamilton Vol#: 4

EC 263 Mrs. Leann Gillaspie Vol#: 4

EC 264 Mrs. Kimberly Womack Vol#: 4

EC 265 Mannatech Vol#: 4

EC 266 Ms. Jackie Denig Vol#: 4

EC 267 Mr. Thomas Miller Vol#: 4

EC 268 Ms. Sarah Timme Vol#: 4

EC 269 Ms. Katrina Vaillancourt Vol#: 4

EC 270 Mrs. Susanne Brown Vol#: 4

EC 271 Mr. Don Heineman Vol#: 4

EC 272 Ms. Peggy Kralik Vol#: 4

EC 273 Ms. Teresa Whyte Vol#: 4

EC 274 Mr. Eldon Larson Vol#: 4

EC 275 Mrs. Sheila Reetz Vol#: 4

EC 276 Mr. David Jonas Vol#: 4

EC 277 Mrs. Jean Galvin Vol#: 4

EC 278 Mannatech Vol#: 4

EC 279 Mr. Sam Prestwich Vol#: 4

EC 280 Mrs. Nancy Choate Vol#: 4

EC 281 Mr. James Moore Vol#: 4

EC 282 Concerned citizen Vol#: 4

EC 283 None Vol#: 4

EC 284 Mrs. Paula Brewer Vol#: 4

EC 285 Mr. Bruce Baier Vol#: 4

EC 286 Mr. bill healey Vol#: 4

EC 287 Dr. Tim Jaeger Vol#: 4

EC 288 Ms. Bliss Terrill Vol#: 4

EC 289 Ms. Helen Rabourn Vol#: 4

EC 290 Attorney Vol#: 4

EC 291 Attorney at Law and Nutritional Consulta Vol#: 4

EC 292 Ms. Lynn Campbell Vol#: 4

EC 293 Scott's Grocery Vol#: 4

EC 294 Ms. Melinda Delisle Vol#: 4

EC 295 Ms. Patricia Onsager Vol#: 4

EC 296 Mr. Grant Bennett Vol#: 4

EC 297 Mr. Mel Henderson Vol#: 4

EC 298 individual Vol#: 4

EC 299 Mrs. Tracy Perry Vol#: 4

EMC 15 Frank Walling Vol#: 5

EMC 16 Margaret Gilhooley Vol#: 5

EMC 17 Sandy V. George Vol#: 5

EMC 18 Marlene Seller Vol#: 5

EMC 19 Ilse Webb Vol#: 5

EMC 20 Norman and Lynn Phillips Vol#: 5

EMC 21 Janet L. Eads Vol#: 5

EMC 22 Health Law Advocates Vol#: 5

EMC 23 Gary Webb Vol#: 5

EMC 24 Norman Phillips Vol#: 5

EMC 25 J. Regenold Vol#: 5

EMC 26 Byron Choate Vol#: 5

EMC 27 Norma Chudleigh Vol#: 5

EMC 28 Lois Hill Vol#: 5

02N-0276 Bioterrorism Preparedness;Registration of Food Facilities

EMC 1 Thomas Leitgen Vol#: 1

EMC 2 Thomas Leitgen Vol#: 1

EMC 3 Embassy of Argentina Meeting Notes Vol#: 1

02N-0278 Bioterrorism Preparedness;Pior Notice of Imported Food Shipm

EMC 1 William Hastback Vol#: 1

EMC 2 William Hastback Vol#: 1

02P-0075 Flavored Candy-like Products Containing Tobacco

RC 2 Star Scientific, Inc. Vol#: 2


02P-0135 Orally-Administered Levothyroxine Sodium all NDAs & ANDAs

M 3 HFD-820 Vol#: 1

02P-0207 SRNT petition to regulate SF Garrett's Nicotine Water

EMC 5 Steve Kleine Vol#: 1

02P-0317 Recall Aspartame as a Neurotoxic Drug

EMC 1 Hon Annette King Vol#: 1

02P-0346 ANDA Amiodarone Hydrochloride Injection 450mg/9ml single use

ACK 1 HFA-305 Vol#: 1

CP 1 Gensia Sicor Pharmaceuticals Vol#: 1