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 August 14, 2002

TABLE OF CONTENTS

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99P-5448 ANDA Suitability for Cefaclor Dispersable Tablets *
99P-5450 ANDA Suitability for Amoxicillin Dispersible Tablets *
99P-5451 ANDA Suitability for Cephalexin Dispersible Tablets *
99P-5452 ANDA Suitability for Acyclovir Dispersible Tablets *
99P-5453 *
00N-1571 Enrofloxacin for Poultry: Opportunity for hearing *
00N-1652 Human Prescripton Drugs/Biologics in Electronic Format *
01D-0435 International Conference on Harmonisation *
01N-0067 Reclassification of Dental Mercury *
01P-0358 ANDA for drug Carbidopa-Levodopa dispersible tablets, 10mg *
02D-0231 Stability Data Pack for Registration Climatic Zones lll & IV *
02D-0237 QIE Evaluation of Stability Data *
02D-0242 Pharmacy Compounding Compliance Policy Guide *
02D-0258 Sudies for Orally Administered Drug Products *
02N-0209 Governing First Amendment Case Law *
02P-0059 Refrain from Approving ANDA for Isotretinoin Drug Products *
02P-0067 All estrogen-containing products intended for oral use *
02P-0246 Pharmacies of hospitals/other health care entities *
02P-0363 NDA 20-560: Fosamax (Alendronate Sodium Tablets) *

86F-0208 MYCO-PROTEIN DERIVED FROM FUSARIUM GRANINEARUM SOURCE PRO

EMC 2 Sherri D. Sokol Vol#: 1

EMC 3 Tim Kunkelman Vol#: 1

EMC 4 Jude A. Watts Vol#: 1

EMC 5 Kelly Malone Vol#: 1

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

C 381 Luci Rizzo Vol#: 13

C 382 Mrs. D. A. Moore Vol#: 13

C 383 Evelyn J. Breitfeller Vol#: 13

C 384 Deborah S. Cody Vol#: 13

C 385 Jewell McIlmoil Vol#: 13

C 386 Katherine E. Crosser Vol#: 13

C 387 Fran Wilson Vol#: 13

C 388 Kitty Hightower Vol#: 13

C 389 Madeline Vadnais Vol#: 13

C 390 Tonni Caughey Vol#: 13

C 391 Cheryl Heisler Vol#: 13

C 392 Robin L. Cotter Vol#: 13

C 393 Barbara M. Boudreau Vol#: 13

C 394 Gloria Tlnes Vol#: 13

C 395 Patricia Garley Vol#: 13

C 396 David Gray Vol#: 13

C 397 Diane M. Coryell Vol#: 13

98F-0052 Provide for the safe use of Neotame, non-nutritive sweetener

SUP 16 Betty Martini Vol#: 5

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

C 5879 Anne Adams Helms Vol#: 251

C 5880 Christina Watson Vol#: 251

C 5881 Ms. Betty Stewart Vol#: 251

C 5882 Gary Grigsby Vol#: 251

C 5883 Taylor Jacobson Vol#: 251

C 5884 Joanne Lind Vol#: 251

C 5885 Johanna R. Saxon Vol#: 251

C 5886 April Hosty Vol#: 251

EMC 2809 Jan Saxton Vol#: 243

EMC 2810 Nana Paldi Vol#: 243

EMC 2811 Nicole Morrow Vol#: 243

EMC 2812 Chris Pastor Vol#: 243

EMC 2813 Lisa Graham Vol#: 243

EMC 2814 Joyce Willson Vol#: 243

EMC 2815 Myriam Giovannini Vol#: 243

EMC 2816 Neely Ross Vol#: 243

EMC 2817 Jay D. Salisbury & Royale A. Schulze Vol#: 243

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

EMC 323 Marilin Engelman Vol#: 5

EMC 324 Marilin Engelman Vol#: 5

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

EMC 226 Marilin Engelman Vol#: 5

EMC 227 Marilin Engelman Vol#: 5

99F-5322 Ionizing Radiation for the Treatment of Food

EMC 225 Marilin Engelman Vol#: 4

EMC 226 Marilin Engelman Vol#: 4

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

EMC 228 Marilin Engelman Vol#: 4

EMC 229 Marilin Engelman Vol#: 4

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

EMC 3691 Marilin Engelman Vol#: 512

99P-5448 ANDA Suitability for Cefaclor Dispersable Tablets

LET 1 HFD-560 to The Weinberg Group, Inc Vol#: 1

99P-5450 ANDA Suitability for Amoxicillin Dispersible Tablets

LET 1 HFD-560 to The Weinberg Group, Inc. Vol#: 1

99P-5451 ANDA Suitability for Cephalexin Dispersible Tablets

LET 1 HFD-560 to The Weinberg Group, Inc. Vol#: 1

99P-5452 ANDA Suitability for Acyclovir Dispersible Tablets

LET 1 HFD-560 to The Weinberg Group, Inc. Vol#: 1

99P-5453

LET 1 HFD-560 to The Weinberg Group, Inc. Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9822 Nelson Stalcup Vol#: 570

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

RMO 10 Center for Veterinary Medicine Vol#: 270

SUP 4 Bayer Corporation Vol#: 270

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

C 7 Bristol-Myers Squibb Vol#: 1

C 8 Aventis Pharmaceuticals, Inc. Vol#: 1

01D-0435 International Conference on Harmonisation

C 9 Aventis Pharmaceuticals, Inc. Vol#: 1

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

EMC 325 Marilin Engelman Vol#: 6

EMC 326 Marilin Engelman Vol#: 6

01N-0067 Reclassification of Dental Mercury

C 30 Academy of General Dentistry (AGD) Vol#: 5

C 31 Norman Wolson Vol#: 5

EMC 289 Debbie Bevel Vol#: 6

EMC 290 Eva Anderson Vol#: 6

EMC 291 Linda McCraney Vol#: 6

EMC 292 Linda McCraney Vol#: 6

EMC 293 Consumers for Dental Choice, Inc. Vol#: 6

EMC 294 Johnson Drugs Vol#: 6

EMC 295 Pat Greer Vol#: 6

EMC 296 Mary Ann Newell Vol#: 6

EMC 297 Mary Ann Newell Vol#: 6

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 940 Form letter count 95 Vol#: 216

C 941 Nancy A. Green Vol#: 209

EMC 2244 John Bass Vol#: 212

EMC 2245 Mitchell Solovay, RN Vol#: 212

EMC 2246 Ellen C. Suter Vol#: 212

EMC 2247 Joshua Simpson Vol#: 212

EMC 2248 Doreen Haarmann Vol#: 212

EMC 2249 Mark Damato Vol#: 212

EMC 2250 Theresa J. Rossiter Vol#: 212

EMC 2251 Richard Rossiter Vol#: 212

EMC 2252 Maureen Swanson Vol#: 212

EMC 2253 M. Salas Vol#: 212

EMC 2254 Rachel Gregory Vol#: 212

EMC 2255 Ricky Walker Vol#: 212

EMC 2256 Lynn Houston Vol#: 212

EMC 2257 Steven J. Birchler Vol#: 212

EMC 2258 Florence Vincent Vol#: 212

EMC 2259 Virginia M. Donnelly Vol#: 212

EMC 2260 Timothy O'Shea Vol#: 212

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

EMC 1099 Jenny Went Vol#: 5

EMC 1100 Michelle Noonan Vol#: 5

01P-0358 ANDA for drug Carbidopa-Levodopa dispersible tablets, 10mg

PAV 1 HFD-560 to The Weinberg Group, Inc. Vol#: 1

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

C 5 Aventis Pharmaceuticals, Inc. Vol#: 1

02D-0237 QIE Evaluation of Stability Data

C 5 Aventis Pharmaceuticals Inc. Vol#: 1

C 6 Jerussi Consulting, Inc. Vol#: 1

02D-0242 Pharmacy Compounding Compliance Policy Guide

EMC 1 National Assn of Chain Drug Stores Vol#: 1

02D-0258 Sudies for Orally Administered Drug Products

C 6 MDS Pharma Services Vol#: 1

C 7 AstraZeneca Vol#: 1

C 8 PhRMA Vol#: 1

EMC 1 Walter W. Hauck, PhD Vol#: 1

EMC 2 Pfizer Vol#: 1

EMC 3 GlaxoSmithKline Vol#: 1

02N-0114 Reclassification of Root-form Endosseous Dental Implants

C 1 Straumann, USA Vol#: 1

02N-0209 Governing First Amendment Case Law

C 17 Jack Reed (CI) Vol#: 5

02P-0059 Refrain from Approving ANDA for Isotretinoin Drug Products

LET 1 HFD-1 to Covington & Burling Vol#: 1

02P-0067 All estrogen-containing products intended for oral use

LET 1 HFD-1 to Physicians CXommittee for Respo Vol#: 1

02P-0246 Pharmacies of hospitals/other health care entities

LET 1 University of Colorado Hospital Vol#: 1

02P-0363 NDA 20-560: Fosamax (Alendronate Sodium Tablets)

ACK 1 HFA-305 Vol#: 1