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 September 6, 2000

TABLE OF CONTENTS

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78N-0038 Sunscreen Drug Products *
98N-0331 Medical Devices;Implementation third party review under FDA *
98N-1038 Irradiation in the production, processing, &handling of food *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-4613 Revoke the Regulation That Approved Posilac *
00N-0504 Egg Safety Action Plan *
00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair *
00P-1499 Remove alosetron (Lotronex) from the market *
00P-1500 Allow Dietary Supple Mfg to list ingredients aphabetically *
78N-0038 Sunscreen Drug Products

ACK 5 Ciba Specialty Chemicals Corporation Vol#: 139

C 564 Playtex Products, Inc Vol#: 134

C 565 Schering-Plough Vol#: 134

C 566 Johnson & Johnson Consumer Companies,Inc Vol#: 134

C 567 L'OREAL USA Vol#: 135

C 568 Neutrogena Corporation Vol#: 136

C 569 L'Oreal Reaearch/L'Oreal USA Vol#: 136

C 570 Deptartment of the Army Vol#: 136

C 571 Tayca Corporation & Tri-K Industries,Inc Vol#: 136

C 572 L'OREAL USA Vol#: 137

C 573 The Cosmetic, Toiletry & Fragrance Assn Vol#: 138

CP 13 Ciba Specialty Chemicals Corporation Vol#: 139

EXT 9 The Estee Lauder Companies Vol#: 134

98N-0144 Elimination of establishment license/product license

NCR 2 Vol#: 1

98N-0331 Medical Devices;Implementation third party review under FDA

C 3 AdvaMed, Advanced Med. Technology Assn. Vol#: 1

C 4 NEMA, National Electrical Mfrs. Assn. Vol#: 1

C 5 CITECH Vol#: 1

C 6 BSI, Inc. Vol#: 1

C 7 MDMA, Medical Device Manufacturers Assn. Vol#: 1

98N-1038 Irradiation in the production, processing, &handling of food

EMC 226 M Patrick Vol#: 151

99N-1819 Topical Antifungal Drug Products

NFR 1 Vol#: 1

99P-1340 Declared Eternity eau de Parfum Misbranded

C 664 B Roth Vol#: 16

99P-2630 Establish a Daily Value for "added sugars"

C 213 B Kapner Vol#: 10

C 214 A Artemis Vol#: 10

C 215 J M & P S Nurius Vol#: 10

C 216 J Wiss Vol#: 10

C 217 M Bowman Vol#: 10

C 218 I & D Greenberg Vol#: 10

C 219 E Bass Vol#: 10

C 220 J L Hagerich Vol#: 10

C 221 M Hamiltion Vol#: 10

C 222 J Doughty Vol#: 10

C 223 S Menconi Vol#: 10

C 224 P Silverman Vol#: 10

C 225 J Williams Vol#: 10

C 226 K Dziezynski Vol#: 10

C 227 J C Rigney Vol#: 10

C 228 W Young Vol#: 10

C 229 R Evans Vol#: 10

C 230 K Wettstein Vol#: 10

C 231 O Adashunas Vol#: 10

C 232 L Weissman Vol#: 10

C 233 S Bleiweiss Vol#: 10

C 234 D Lipkin Vol#: 10

C 235 G Chapman Vol#: 10

C 236 F G Arellano Vol#: 10

C 237 J Jackson Vol#: 10

C 238 J McCoy Vol#: 10

C 239 H Schwartz Vol#: 10

C 240 K E Ahrens Vol#: 10

C 241 M Levengood Vol#: 10

C 242 I Blackford Vol#: 10

C 243 R & C Heckscher Vol#: 10

C 244 B Evans Vol#: 10

C 245 J & B Murray Vol#: 10

C 246 V & C Diamond Vol#: 10

C 247 D Flowers Vol#: 10

C 248 J Hicks Vol#: 10

C 249 N Barnett Vol#: 10

C 250 D Willett Vol#: 10

C 251 I Leiby Vol#: 10

C 252 A Perner Vol#:

C 253 M McCormick Vol#: 10

C 254 T Brown Vol#: 10

C 255 C Gougar Vol#: 10

C 256 E Fisher Vol#: 10

C 257 B Polome Vol#: 10

C 258 N Hiestand Vol#: 10

C 259 Unsigned Vol#: 10

C 260 J S Diloveto Vol#: 10

C 261 C Stuckey Vol#: 10

C 262 A Lockwood Vol#: 10

C 263 M Pratt Vol#: 10

C 264 E Ayers Vol#: 10

C 265 C O'Rourke Vol#: 10

C 266 D W Welti MD Vol#: 10

C 267 M Affeld Vol#: 10

C 268 M Earley Vol#: 10

C 269 Da Beakley Vol#: 10

C 270 P Ziegenfuss Jr Vol#: 10

C 271 S Karhu Vol#: 10

C 272 N Becker Vol#: 10

C 273 D Pedace Vol#: 11

C 274 M Tumulty Vol#: 11

C 275 A Knoblock Vol#: 11

C 276 A Artemel Vol#: 11

C 277 M Cain Vol#: 11

C 278 B Bushy Vol#: 11

C 279 A Braun Vol#: 11

C 280 E Kupferman Vol#: 11

C 281 M Vincent Vol#: 11

C 282 N Smith Vol#: 11

C 283 D Gier Vol#: 11

C 284 K Glasgow Vol#: 11

C 285 R Kovach Vol#: 11

C 286 E Herzog Vol#: 11

C 287 L Woodhams Vol#: 11

C 288 E McCarron MD Vol#: 11

C 289 W Guenkel Vol#: 11

C 290 D W Welt MD Vol#: 11

C 291 J Cole Vol#: 11

C 292 G Savage Vol#: 11

C 293 K Pinney Vol#: 11

C 294 J Askham Vol#: 11

C 295 W & L Sellman Vol#: 11

C 296 R & C Sharron Vol#: 11

C 297 T Popovits Vol#: 11

C 298 C Newman Vol#: 11

C 299 N Pendic Vol#: 11

C 300 T III Vol#: 11

C 301 R Furman Vol#: 11

99P-4613 Revoke the Regulation That Approved Posilac

EMC 2328 V. Bacigalupi Vol#: 43

00H-1436 Civil Money Penalty;Pure Water Inc.,& Ted M Walters & Cynthi

LET 2 GCF-1 & Pure Water Inc Vol#: 1

00N-0504 Egg Safety Action Plan

C 70 R. Snyder, Ph.D. Vol#: 8

C 71 S LaPoint Vol#: 8

C 72 L Baumann Vol#: 8

C 73 G Carlsen Vol#: 8

C 74 J Cammer Vol#: 8

C 75 S. Montague Vol#: 8

C 76 J. Embry Vol#: 8

C 77 G. Dellinger Vol#: 8

C 78 K Kindel Vol#: 8

C 79 S Pelch Vol#: 8

C 80 K DeSalvatore Vol#: 8

EMC 290 G Wiesner Vol#: 8

TR 3 Egg Saftey Public Meeting 7/31/00 Vol#: 9

00N-1256 Over-the-Counter Drug Products;Public Hearing

CH 618 Richard D. Murray Vol#: 24

CH 619 Christine Evan Vol#: 24

CH 620 Terry M. Vanden Bosch, RN Vol#: 24

CH 621 Sheryl Wilson, MBA Vol#: 24

CH 622 Sylvia Coppersmith Vol#: 24

CH 623 Jeffrey Wyckoff Vol#: 24

00N-1367 Postmarket Surveillance

NPR 1 Vol#: 1

00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair

C 22 Telos Vol#: 1

C 23 AAOS, American Assn. of Orthopaedic Surg Vol#: 1

C 24 American Red Cross Vol#: 1


00P-1499 Remove alosetron (Lotronex) from the market

ACK 1 HFA-305 Vol#: 1

CP 1 Public Citizen Vol#: 1

00P-1500 Allow Dietary Supple Mfg to list ingredients aphabetically

ACK 1 HFA-305 Vol#: 1

CP 1 Arnall Golden & Gregory LLP Vol#: 1