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 13, 2000

TABLE OF CONTENTS

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95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient *
97N-0436 Methods informing consumers of contents of bottle water *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-4613 Revoke the Regulation That Approved Posilac *
00D-1336 Pediatric Oncology Studies in Response to a Written Request *
00D-1350 Combined Oral Contraceptives/Labeling/Healthcare Providers *
00D-1393 Screening tests labeled for use w/ Cadaveric blood Specimens *
00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1406 Stay Presenting, publishing promulgating "Fresh Air" Speeche *
00V-1514 Laser Light Show *

95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient

C 296 P Schneider Vol#: 5

EMC 47 Betsy Lerman Zucker, RN, MSN Vol#: 5

EMC 48 University of Pennsylvania Sch. of Medic Vol#: 5

EMC 49 Dordt College Vol#: 5

EMC 50 H. Raschke, Ph.D. Vol#: 5

EMC 51 L Kremer Vol#: 5

EMC 52 L GreenbergP Vol#: 5

EMC 53 President Medical Students for Choice Vol#: 5

EMC 54 D. Nguyen, M.D. Vol#: 5

EMC 55 J Stunkel Vol#: 5

EMC 56 J Meyer Vol#: 5

EMC 57 Susan Rubin Vol#: 5

97N-0436 Methods informing consumers of contents of bottle water

C 215 R. Stiles Vol#: 7

C 216 T Harold Vol#: 7

C 217 T. Dean Vol#: 7

C 218 K. Wilson & Others Vol#: 7

C 219 R Shanok Vol#: 7

C 220 R. Carr Vol#: 7

C 221 R Berman Vol#: 7

C 222 G Pennington Vol#: 7

C 223 N. Rutenber Vol#: 7

EMC 63 J Buss Vol#: 7

EMC 64 M Robbins Vol#: 7

98N-0337 Over the counter human drugs labeling requirements

ANS 8 HFD-560 to Block Drug Company, Inc. Vol#: 6

99P-1340 Declared Eternity eau de Parfum Misbranded

EMC 168 K. Webster Vol#: 16  

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

C 302 Osseointegrated Dental Implants Vol#: 12

C 303 M Kingman Vol#: 12

C 304 P Rynders Vol#: 12

C 305 J Bancroft Vol#: 12

C 306 B Baxendale Vol#: 12

C 307 R Roehrs PhD Vol#: 12

C 308 C Pospisil Vol#: 12

C 309 B Krumbein Vol#: 12

C 310 J Inskeep Vol#: 12

C 311 P Edelstein Vol#: 12

C 312 S Cutter Vol#: 12

C 313 M Merrill Vol#: 12

C 314 L Baskervill Vol#: 12

C 315 V Bentley Vol#: 12

C 316 E Golden Vol#: 12

C 317 H Nelson Vol#: 12

C 318 N Sasseen Vol#: 12

C 319 C Putz Vol#: 12

C 320 M Lucky Vol#: 12

C 321 M Kadziel Vol#: 12

C 322 R Burlingame Vol#: 12

C 323 M Johnson Vol#: 12

C 324 R Goodfellow Vol#: 12

C 325 C Fletcher Vol#: 12

C 326 L Wendt Vol#: 12

C 327 A Shapiro Vol#: 12

C 328 F Sauline Vol#: 12

C 329 R Levin Vol#: 12

C 330 M Kaye Vol#: 12

C 331 N Mcbride Vol#: 12

C 332 D Blankenship Vol#: 12

C 333 V Masterson Vol#: 12

C 334 R Blake Vol#: 12

C 335 A Perez Vol#: 12

C 336 S Marlin Vol#: 12

C 337 A Craine Vol#: 12

EMC 135 S Sparks Vol#: 11

EMC 136 B Aston Vol#: 11

EMC 137 A Millican Vol#: 11

EMC 138 M Mularkey Vol#: 11

EMC 139 S Granger Vol#: 11

EMC 140 T Gifford Vol#:

EMC 141 S Silverman Vol#: 11

EMC 142 R Suntay Vol#: 11

EMC 143 J Rardin Vol#: 11

EMC 144 C Yorio Vol#: 11

EMC 145 Ry Rieb Vol#: 11

EMC 146 CCRPER Vol#: 11

EMC 147 N Fryman Vol#: 11

EMC 148 M Klein Vol#: 11

EMC 149 S Stewart Vol#: 11

EMC 150 J Lawless Vol#: 11

EMC 151 C Burke Vol#: 11

EMC 152 A Reynolds Vol#: 11

EMC 153 Ro Rex Vol#: 11

EMC 154 B Baxendale Vol#: 11

EMC 155 J Gill Vol#: 11

EMC 156 A Tripp Vol#: 11

EMC 157 A Petron Vol#: 11

EMC 158 S Byram Vol#: 11

EMC 159 E Henderson Vol#: 11

EMC 160 A Rea Vol#: 11

EMC 161 N Patch Vol#: 11

EMC 162 P Souders Vol#: 11

EMC 163 J Alverson Vol#: 11

EMC 164 J Stryker Vol#: 11

EMC 165 S Klein Vol#: 11

EMC 166 J Resnik Vol#: 11

EMC 167 D Hart Vol#: 11

EMC 168 P Martin Vol#: 11

EMC 169 K Joslin Vol#: 11

EMC 170 L Terry Vol#: 11

EMC 171 J Bier Vol#: 11

EMC 172 R Hickok Vol#: 11

EMC 173 D Meghreblian Vol#: 11

EMC 174 S Goldman Vol#: 11

EMC 175 J Carnahan Vol#: 11

EMC 176 L Cofer Vol#: 11

EMC 177 D Mariya Vol#: 11

EMC 178 K Strasburger Vol#: 11

EMC 179 S Hendrix Vol#: 11

EMC 180 D Rau Vol#: 11

EMC 181 J George Vol#: 11

EMC 182 A Munsell Vol#: 11

EMC 183 L Wallisch Vol#: 11

EMC 184 P MacKenzie Vol#: 11

EMC 185 S Papp Vol#: 11

EMC 186 C Keefe Vol#: 11

EMC 187 C Hinkle Vol#: 11

EMC 188 C Mays Vol#: 11

EMC 189 C Meier Vol#: 11

EMC 190 N Stewart Vol#: 11

EMC 191 A Thompson Vol#: 11

EMC 192 L Kirk Vol#: 11

EMC 193 L Gloede Vol#: 11

EMC 194 J Kent Vol#: 11

EMC 195 J O'Neil Vol#: 11

EMC 196 D Augenblick Vol#: 11

EMC 197 R Levin Vol#: 11

EMC 198 L Wheeler Vol#: 11

EMC 199 J Herold Vol#: 11

EMC 200 A Saperstein Vol#: 11

EMC 201 E Harvey Vol#: 11

EMC 202 I Rappaport Vol#: 11

EMC 203 W Orr Vol#: 11

EMC 204 K B Holmes Jr Vol#: 11

EMC 205 Andrea Hill Vol#: 11

EMC 206 P Gross Vol#: 11

EMC 207 H Sylvester Vol#: 12

EMC 208 A Whittaker Vol#: 12

EMC 209 R Evans Vol#: 12

EMC 210 M Josephs Vol#: 12

EMC 211 M Garrell Vol#: 12

EMC 212 J Elliott Vol#: 12

EMC 213 D Lejeune Vol#: 12

EMC 214 D Mathias Vol#: 12

EMC 215 M Holmes Vol#: 12

EMC 216 S Patterson Vol#: 12

EMC 217 D Damoth Vol#: 12

EMC 218 M Schneps Vol#: 12

EMC 219 P Vance Jr Vol#: 12

EMC 220 C Park Vol#: 12

EMC 221 A Grossman Vol#: 12

EMC 222 S Cook Vol#: 12

EMC 223 M Burke Vol#: 12

EMC 224 Pcelauro Vol#: 12

EMC 225 M Snider Vol#: 12

EMC 226 M Henderson Vol#: 12

EMC 227 G Hofer Vol#: 12

EMC 228 P Minola Vol#: 12

EMC 229 N Howard Vol#: 12

EMC 230 J Whithall Vol#: 12

EMC 231 C Bomtraeger Vol#: 12

EMC 232 M Strassner Vol#: 12

EMC 233 C Walsh Vol#: 12

EMC 234 L Sayer Vol#: 12

EMC 235 B Therrell Vol#: 12

EMC 236 S Bray Vol#: 12

EMC 237 H Bray Vol#: 12

EMC 238 D Nolan Vol#: 12

EMC 239 L Martin Vol#: 12

EMC 240 M Curran Vol#: 12

EMC 241 J Van Dorn Vol#: 12

EMC 242 R Clark Vol#: 12

EMC 243 C Macintosh Vol#: 12

EMC 244 J Stephens PhD Vol#: 12

EMC 245 B Cagnoni Vol#: 12

EMC 246 L Straight Vol#: 12

EMC 247 S Mavin Vol#: 12

EMC 248 R Sweeney Vol#: 12

EMC 249 B Williamson Vol#: 12

EMC 250 M Scott Vol#: 12

EMC 251 S Rogers-Lipsey Vol#: 12

EMC 252 J Enkoji Vol#: 12

EMC 253 R Petterson Vol#: 12

EMC 254 J Roosa Vol#: 12

EMC 255 G1H2ost Vol#: 12

EMC 256 E Augustine Vol#: 12

EMC 257 J Steudte Vol#: 12

EMC 258 J Fanney Vol#: 12

EMC 259 F Fish Vol#: 12

EMC 260 R Plutchik Vol#: 12

EMC 261 B Robbins Vol#: 12

EMC 262 M Wemple Vol#: 12

EMC 263 S Dove Vol#: 12

EMC 264 J Wise Vol#: 12

EMC 265 C Cohn Vol#: 12

EMC 266 I Sylvia Vol#: 12

EMC 267 Aa Baxter Vol#: 12

EMC 268 G Mounkes Vol#: 12

EMC 269 A Miner Vol#: 12

EMC 270 E Bartolome Vol#: 12

EMC 271 H Huttash Vol#: 12

EMC 272 R Bessmer Vol#: 12

EMC 273 D J Wherle Vol#: 12

EMC 274 R Feinstein Vol#: 12

EMC 275 R Noble Vol#: 12

EMC 276 B Curtis-Johnson Vol#: 12

EMC 277 L Mahoney Vol#: 12

EMC 278 S O'Connor Vol#: 12

EMC 279 B Stone Vol#: 12

EMC 280 E Shavit Vol#: 12

EMC 281 A Hayes Vol#: 12

EMC 282 L Poirier Vol#: 12

EMC 283 M Vol#: 12

EMC 284 D Anderson Vol#: 12

EMC 285 L Sauer Vol#: 12

EMC 286 M Whiteside Vol#: 12

EMC 287 R Cline Vol#: 12

EMC 288 B Wolf Vol#: 12

EMC 289 J Nixon Vol#: 12

99P-4613 Revoke the Regulation That Approved Posilac

C 1342 Tanig R. Vol#: 43

EMC 2329 Russel K. Vol#: 43

EMC 2330 J McCreary Vol#: 43

EMC 2331 S Ken Vol#: 43

EMC 2332 B Bogner Vol#: 43

00D-1336 Pediatric Oncology Studies in Response to a Written Request

C 1 AstraZeneca Pharmaceuticals LP Vol#: 1

00D-1350 Combined Oral Contraceptives/Labeling/Healthcare Providers

C 3 Organon, Inc. (Akzo Nobel) Vol#: 1

C 4 Reproductive Health Technologies Project Vol#: 1

C 5 NARAL Foundation Vol#: 1

EMC 1 Family Health International Vol#: 1

00D-1393 Screening tests labeled for use w/ Cadaveric blood Specimens

C 3 Sacramento Medical Foundation/Blood Cent Vol#: 1

00D-1497 Mammography Qquality Standards Act; Final Regs Document #4

GDL 1 Guideline Vol#: 1

NAD 1 HFZ-215 Vol#: 1

00F-1482 Safe use of ozone in gaseous & aqueous phases as antimicrobi

NFL 1 HFS-024 Vol#: 1

00H-1242 Civil Money Penalty;Laser Vision Centers Inc. et al

LET 5 LaserVision Vol#: 1

00N-1283 Reporting & Recordkeeping Requirements/Electronic Products

N 2 HFA-250 Vol#: 1

00N-1364 Prescription Drug User Fee Act (PDUFA) Public Meeting

EAPE75 Association of American Medical Colleges Vol#: 1

EAPE76 FDA Vol#: 1

EAPE77 Child and Adolescent Bipolar Foundation Vol#: 1

EAPE78 FDA/CBER/OD Vol#: 1

EAPE79 FDA/OC Vol#: 1

EAPE80 FDA-CBER-OBRR Vol#: 1

EAPE81 American Medical Association Vol#: 1

EAPE82 Purdue Pharma Vol#: 1

EAPE83 Auxiliary to the National Medical Assoc. Vol#: 1

EAPE84 Novartis Vol#: 1

EAPE85 Auxiliary to the National Medical Assoc. Vol#: 1

EAPE86 Meridian Medical technologies Inc. Vol#: 1

EAPE87 Auxiliary to the National Medical Associ Vol#: 1

EAPE88 Video On Location, Inc. Vol#: 1

EAPE89 RW Johnson Pharmaceutical Research Insti Vol#: 1

EAPE90 American Pharmaceutical Association Vol#: 1

EAPE91 The Pink Sheet Vol#: 1

EAPE92 Number Not Used Vol#: 1

EAPE93 Number Not Used Vol#: 1

EAPE94 Number Not Used Vol#: 1

EC 20 J Link Vol#: 1

00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop

C 17 American Soc. for Clinical Laboratory Sc Vol#: 1

00N-1498 Withdrawal of Approval of twenty-eight New Drug Applications

NWL 1 HFD-7 Vol#: 1

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 5800 M Keating Vol#: 244

C 5801 S Spiegel Vol#: 244

C 5802 P Segallis Vol#: 244

C 5803 K Gibbs Vol#: 244

EMC 2259 C Westen Vol#: 243

EMC 2260 A Luna Vol#: 243

EMC 2261 M Kizak Vol#: 243

EMC 2262 D Noha Vol#: 243

EMC 2263 M Draper Vol#: 243

EMC 2264 F. Schneider Vol#: 243

EMC 2265 C Cubbage Vol#: 243

EMC 2266 B Jones Vol#: 243

EMC 2267 B Khan Vol#: 243

EMC 2268 M Levering Vol#: 243

EMC 2269 J Gaglani Vol#: 243

EMC 2270 L Purifoy Vol#: 243

EMC 2271 A. Nett Vol#: 243

EMC 2272 J Spriggs Vol#: 243

EMC 2273 S Clary Vol#: 243

EMC 2274 D Pfeiffer Vol#: 243

EMC 2275 E Budria Vol#: 243

EMC 2276 K Dorn Vol#: 243

EMC 2277 M Hughes Vol#: 243

EMC 2278 B Bennett Vol#: 243

EMC 2279 A McNett Vol#: 243

EMC 2280 M Lawler Vol#: 243

EMC 2281 B Nelson Vol#: 243

EMC 2282 J Pope Vol#: 243

EMC 2283 J Lane Vol#: 243

EMC 2284 R D'Errico Vol#: 243

EMC 2285 D Taliento Vol#: 243

EMC 2286 A Cvitanovich Vol#: 243

EMC 2287 S Armstrong Vol#: 243

EMC 2288 C Gwinn Vol#: 243

EMC 2289 S Smith Vol#: 243

EMC 2290 E Ridenour Vol#: 243

EMC 2291 F Worrell Vol#: 243

EMC 2292 R. Worrell Vol#: 243

EMC 2293 N Bernstein Vol#: 243

EMC 2294 G Black Vol#: 243

EMC 2295 M Hanson Vol#: 243

EMC 2296 L Chace Vol#: 243

EMC 2297 S Breslin Vol#: 243

EMC 2298 E Avdagic Vol#: 243

EMC 2299 N Tichenor Vol#: 243

EMC 2300 K Shapiro & Family Vol#: 243

EMC 2301 N Mason Vol#: 243

EMC 2302 D Stowell Vol#: 243

EMC 2303 T Norgren Vol#: 243

EMC 2304 Y Sasaki Vol#: 243

EMC 2305 C Mortimer Vol#: 243

00P-1406 Stay Presenting, publishing promulgating "Fresh Air" Speeche

C 2 Messer MG Industries Vol#: 1

00P-1439 Iceberg Water Deviating From Identity Standard

NTP 1 Iceberg Industries Corp. Vol#: 1

00V-1514 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Mainstream Music Vol#: 1