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] 

DOCKETS ENTERED on 03/22/00

Table of Contents

(Hyper links are part of the Docket  title - not all dockets/documents are linked)

[FDA DOCKETS PAGE][FDA HOME PAGE]  [ ITEM CODES ]

 
78N-0038 Sunscreen Drug Products*
78N-036L OTC Laxative *
83V-0182 Laser light show *
86V-0315 Ion laser technology series ILT 5000 Demo unit *
91V-0204 Laser Light Show*
91V-0509 Las Vegas laser rental light shows. *
94V-0306 Laser Light Show*
94V-0448 Variance for L75 IR Laser Sight System *
95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability *
96P-0215 Withdrawal Norplant's approval for sale in the United States *
97D-0261 Asked Questions about FDA Tobacco Regulations *
97D-0268 Container Closure Systems Used for Packaging of Human Drugs *
98N-0581 Requirements for Testing Human Blood Donors *
99D-4130 Manufacturers to assemblers for Diagnostic X-Ray Systems *
99D-4809 Applications Covered by Section 505(b)(2) *
99D-5047 Industry on Pharmacokinetics in Patients with Impaired Hepat *
99D-5435 Draft Guidance for Industry on Photosafety Testing *
99N-4783 Administrative Practices & Procedures;Good Guidance Practice *
99N-4784 Redacted Version of Substantially-Equivalent Premarket Notif *
99P-2148 Label or Labeling of food ingredients and regulation *
99P-2252 Pamidronate Disodium Injection 3 mg/ml,6 mg/ml,9 mg/ml *
99P-3083 Determine if Neurontin (Gabapentin) tablets 600mg & 800 have *
99P-4053 Sympathominetic Amine Phentermine *
99P-4648 Grated Parmesan Cheese Deviating from Identity Standards *
99P-5106 Identify Sources of Natural Flavorings *
99P-5215 Provisions of Title 21 of the Code of Federal Regulations *
99V-2629 Laser Light Show (Gemini Laser Corporation) *
99V-4332 Laser Light Show Projector *
99V-5014 Laser Light Show*
99V-5323 Laser Light Show Mobolazer ML 10-200, ML-10-200,ML-300 *
99V-5407 Laser Light Show*
99V-5525 *
00D-0053 Reprocessing&Reuse of Single-Use Devices/Risk Categorization *
00N-0088 Psychiatric & Behavioral Disturbances associated w/Dementia *
00N-0352 Status of Useful written prescription drug info for Patients *
00P-0499 Review/Act on SKB '132 Form C & '423 Form A patent for NDA20 *
00P-1210 Restrict Sale of Coal Tar-Containing Products *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00V-0570 Laser Light Show*
00V-0724 Laser Light Show, Laser Art Series *
78N-0038 Sunscreen Drug Products

PAV 3 HFD-110 & Procter & Gamble Company Vol#: 111

78N-036L OTC Laxative

ACK 3 HFA-305 Vol#: 107

C 201 Boehringer Ingelheim Vol#: 107

C 202 Purdue Pharma L. P. U.S. Reg Affairs Vol#: 107

PRC 2 C.B. Fleet Company, Inc. Vol#: 107

83V-0182 Laser light show

VRA 6 HFZ-300 & South Florida Museum & Bishop Vol#: 1

86V-0315 Ion laser technology series ILT 5000 Demo unit

VRA 8 HFZ-300 & Engineering Laser Specialist Vol#: 1

91V-0204 Laser Light Show

VRA 5 HFZ-300 & Mare-Bare, Incorporated Vol#: 1

91V-0509 Las Vegas laser rental light shows.

VRA 5 HFZ-300 & Las Vegas Laser Rental Vol#: 1

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

EMC 463 Sandie Gaertner Vol#: 57

EMC 464 Richard Laeng Vol#: 57

EMC 465 Evon Vol#: 57

EMC 466 James S. Dewar Vol#: 57

94V-0306 Laser Light Show

VRA 4 HFZ-300 & Laserlight Shows & Devices Vol#: 1

94V-0448 Variance for L75 IR Laser Sight System

VRA 2 HFZ-300 & Laser Products Vol#: 1

95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability

C 3699 The Honorable Rick Santorum (CI) Vol#: 293

96P-0215 Withdrawal Norplant's approval for sale in the United States

C 221 T Murphy Vol#: 6

97D-0261 Asked Questions about FDA Tobacco Regulations

C 10 R Morissett Vol#: 1

97D-0268 Container Closure Systems Used for Packaging of Human Drugs

C 32 Pharmaceutical Res & Manuf of America Vol#: 4

97N-0217 Animal Drug Approvals for Minor Species & for Minor Uses

C 113 Mississippi State Vol#: 3

98N-0581 Requirements for Testing Human Blood Donors

C 24 Lehigh Valley Hospital Vol#: 5

99D-4130 Manufacturers to assemblers for Diagnostic X-Ray Systems

C 4 Northside Hospital Vol#: 1

99D-4809 Applications Covered by Section 505(b)(2)

C 4 SmithKline Beecham Vol#: 1

C 5 National Assn of Pharmaceutical Manuf Vol#: 1

99D-5047 Industry on Pharmacokinetics in Patients with Impaired Hepat

C 10 Meretek The Breath Test Company Vol#: 1

C 11 Guidant Corporation Vol#: 1

99D-5435 Draft Guidance for Industry on Photosafety Testing

C 1 M Caswell Vol#: 1

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

C 3229 Form letter count 15 Vol#: 272

C 3230 Form letter count 96 Vol#: 273

C 3231 Form letter count 38 Vol#: 274

C 3232 J G Ferrabee Vol#: 265

C 3233 B Picarelli Vol#: 265

C 3234 G Synodinos Vol#: 265

C 3235 K Wong Vol#: 265

C 3236 E Meece Vol#: 265

C 3237 V Hickerson Vol#: 265

C 3238 E Nino & C Keeney Vol#: 265

C 3239 F Sweet Vol#: 265

C 3240 T Husson Vol#: 265

C 3241 E Willhite Vol#: 265

C 3242 I Everson Vol#: 265

C 3243 D Schneider Vol#: 265

C 3244 D Stillman Vol#: 265

C 3245 C Vernon Vol#: 265

C 3246 J MacArthur Vol#: 265

C 3247 L Moscatelli Vol#: 265

C 3248 L Black Vol#: 265

C 3249 C Eisley Vol#: 265

C 3250 S Grocl Vol#: 265

C 3251 L Levine Vol#: 265

C 3252 R West Vol#: 265

C 3253 S Little Vol#: 265

C 3254 S Wood Vol#: 265

C 3255 D Wiebking Vol#: 265

C 3256 L Griswold Vol#: 265

C 3257 J Shade Vol#: 265

C 3258 M Pollard Vol#: 265

C 3259 L Eiler Vol#: 265

C 3260 L Vecchi & L Altman Vol#: 265

C 3261 E Barich Vol#: 265

C 3262 A Edlin Vol#: 265

C 3263 T Hitzman Vol#: 265

C 3264 L Mitchell Vol#: 265

C 3265 J Williams Vol#: 265

C 3266 J Lindhorst Vol#: 265

C 3267 R Martin Vol#: 265

C 3268 V Santangelo Vol#: 265

C 3269 F Speaks Vol#: 265

C 3270 C Dykes Vol#: 265

C 3271 E Johnson Vol#: 265

C 3272 C Eggers Vol#: 265

C 3273 N Mattingly Vol#: 265

C 3274 L Tacci Vol#: 265

C 3275 T Mcheown Vol#: 265

C 3276 D Christianson Vol#: 265

C 3277 M Hughes Vol#: 265

C 3278 E Lezberg Vol#: 265

C 3279 R Monroe Vol#: 265

C 3280 S Daigre Vol#: 265

C 3281 J Moscitelli Vol#: 265

C 3282 E Roberts Vol#: 265

C 3283 M Webster Vol#: 265

C 3284 J Aument Vol#: 265

C 3285 D Miller Vol#: 265

C 3286 L Crawford Vol#: 265

C 3287 A Kopach Vol#: 265

C 3288 A Tonietto Vol#: 265

C 3289 Q Johannes Vol#: 265

C 3290 P Slavsky Vol#: 265

C 3291 D Pettey Vol#: 265

C 3292 A Cox Vol#: 265

C 3293 A Schick Vol#: 265

C 3294 R McGuire Vol#: 265

C 3295 F Blatnik Vol#: 265

C 3296 E Harper Vol#: 265

C 3297 B Ashley Vol#: 265

C 3298 M Blanchard Vol#: 265

C 3299 L Vinson Vol#: 265

C 3300 A Parker Vol#: 265

C 3301 D Kaufmann Vol#: 265

C 3302 R Dale Vol#: 265

C 3303 P Jack Vol#: 265

C 3304 K Santiago Vol#: 265

C 3305 K Huston Vol#: 265

C 3306 S Makara Vol#: 265

C 3307 M Halmowitz Vol#: 265

C 3308 L Haas Vol#: 265

C 3309 R Edwards Vol#: 265

C 3310 F Bohm Vol#: 265

C 3311 L Rogers Vol#: 265

C 3312 M Bina Vol#: 265

C 3313 E Faukel Vol#: 265

C 3314 T Fullan Vol#: 265

C 3315 L Grable Vol#: 265

C 3316 D Petty Vol#: 265

C 3317 T Hemenway Vol#: 265

C 3318 E Ryon Vol#: 265

C 3319 J Cooper Vol#: 265

C 3320 Kim Family Vol#: 265

C 3321 K Noe Vol#: 265

C 3322 K Albert Vol#: 265

C 3323 D Sage Vol#: 265

C 3324 T Prada Vol#: 266

C 3325 R Jespersen Vol#: 266

C 3326 D Harris Vol#: 266

C 3327 K Conroy Vol#: 266

C 3328 R Rowland Vol#: 266

C 3329 C Brenio Vol#: 266

C 3330 D Newman Vol#: 266

C 3331 J Ashley Vol#: 266

C 3332 G Schneider Vol#: 266

C 3333 M Mould Vol#: 266

C 3334 L Lentile Vol#: 266

C 3335 J Slouck Vol#: 266

C 3336 A Hudgens Vol#: 266

C 3337 S Ponce Vol#: 266

C 3338 M Burgess Vol#: 266

C 3339 J Allen Vol#: 266

C 3340 C Boronski Vol#: 266

C 3341 M Eckhoff Vol#: 266

C 3342 Ja Berkley Vol#: 266

C 3343 R Hauser Vol#: 266

C 3344 A Allen Vol#: 266

C 3345 M Miceli Vol#: 266

C 3346 B Walker Vol#: 266

C 3347 K Crawford Vol#: 266

C 3348 V Gallagher Vol#: 266

C 3349 L Younger Vol#: 266

C 3350 W Presson Vol#: 266

C 3351 P Schwochelt Vol#: 266

C 3352 B Rowland Vol#: 266

C 3353 L Grim Vol#: 266

C 3354 L Dow Vol#: 266

C 3355 R Wright Vol#: 266

C 3356 L Rhodes Vol#: 266

C 3357 K Rise Vol#: 266

C 3358 D Durr Vol#: 266

C 3359 M Reinth Vol#: 266

C 3360 W Hansen Vol#: 266

C 3361 R Savage Vol#: 266

C 3362 V Honea Vol#: 266

C 3363 C Lecher Vol#: 266

C 3364 R White Vol#: 266

C 3365 L Durkes Vol#: 266

C 3366 L Derusha Vol#: 266

C 3367 V Santanello Vol#: 266

C 3368 L Cowan Vol#: 266

C 3369 D Downs Vol#: 266

C 3370 S Kilpatrick Vol#: 266

C 3371 C Schneider Vol#: 266

C 3372 C Bowler Vol#: 266

C 3373 C Duncan Vol#: 266

C 3374 B Klemanek Vol#: 266

C 3375 L Maas Vol#: 266

C 3376 F Martin Vol#: 266

C 3377 M Jinout Vol#: 266

C 3378 R Whelpley Vol#: 266

C 3379 J O'Donnell Vol#: 266

C 3380 R Johnson Vol#: 266

C 3381 C Grossmann Vol#: 266

C 3382 Hn Petkas Vol#: 266

C 3383 R Bachtold Vol#: 266

C 3384 E McDonough Vol#: 266

C 3385 J Ross Vol#: 266

C 3386 J Topping Vol#: 266

C 3387 L Tunick Vol#: 266

C 3388 M Saul Vol#: 266

C 3389 C List Vol#: 266

C 3390 C Strom Vol#: 266

C 3391 J Sarhage Vol#: 266

C 3392 D Trepesowski Vol#: 266

C 3393 K Hook Vol#: 266

C 3394 R Klaesson Vol#: 266

C 3395 Decker Family Vol#: 266

C 3396 S Tjessem Vol#: 266

C 3397 J Shaw Vol#: 266

C 3398 C Albro Vol#: 266

C 3399 B Schnaufer Vol#: 266

C 3400 B Bishoff Vol#: 266

C 3401 S Nicherson Vol#: 266

C 3402 R Monroe Vol#: 266

C 3403 A Kopach Vol#: 266

C 3404 M Brown Vol#: 266

C 3405 F Bohm Vol#: 266

C 3406 M Haimowitz Vol#: 266

C 3407 S Makara Vol#: 266

C 3408 D Arthur Vol#: 266

C 3409 K Curl & M Filiaci Vol#: 266

C 3410 F Blatnik Vol#: 266

C 3411 K Robinson Vol#: 266

C 3412 J Crawford Vol#: 266

C 3413 R Stone Vol#: 266

C 3414 M Comstock Vol#: 266

C 3415 L Elliott Vol#: 266

C 3416 G Alexander Vol#: 266

C 3417 C Whitesel Vol#: 266

C 3418 L Hilligas Vol#: 266

C 3419 E Krebs Vol#: 266

C 3420 J Scurr Vol#: 266

C 3421 R Harik Vol#: 266

C 3422 C Koszalinski Vol#: 266

C 3423 J Buffaloe Vol#: 266

C 3424 D Cretses Vol#: 266

C 3425 L Wersinger Vol#: 266

C 3426 S McCray Vol#: 266

C 3427 L Glance Vol#: 266

C 3428 D Bradley Vol#: 266

99N-4783 Administrative Practices & Procedures;Good Guidance Practice

C 1 Gen-Probe Incorporated Vol#: 1

99N-4784 Redacted Version of Substantially-Equivalent Premarket Notif

C 6 Bayer Corporation Vol#: 1

99P-2148 Label or Labeling of food ingredients and regulation

C 8 The Honorable Gordon H. Smith (CI) Vol#: 1

C 9 The Honorable Michael R. McNulty (CI) Vol#: 1

99P-2252 Pamidronate Disodium Injection 3 mg/ml,6 mg/ml,9 mg/ml

C 2 Wiley, Rein & Fielding Vol#: 1

99P-3083 Determine if Neurontin (Gabapentin) tablets 600mg & 800 have

LET 1 Palmer & Dodge, LLP Vol#: 1

99P-4053 Sympathominetic Amine Phentermine

LET 1 M.I.T & M. C. of Pharmacy & Hlth Sciencs Vol#: 1

99P-4648 Grated Parmesan Cheese Deviating from Identity Standards

ANS 2 HFS-151 Sartori Food Corp. Vol#: 1

99P-5106 Identify Sources of Natural Flavorings

EMC 17 Brenda L. Hoffman Vol#: 1

EMC 18 D Davis Vol#: 1

99P-5215 Provisions of Title 21 of the Code of Federal Regulations

C 1 Wiley, Rein & Fielding Vol#: 1

99V-2629 Laser Light Show (Gemini Laser Corporation)

VRA 1 HFZ-300 & Gemini Laser Corporation Vol#: 1

99V-4332 Laser Light Show Projector

VRA 1 HFZ-300 United Laser Artists Inc Vol#: 1

99V-5014 Laser Light Show

VRA 1 HFZ-300 & Muzic In Motion, Inc Vol#: 1

99V-5323 Laser Light Show Mobolazer ML 10-200, ML-10-200,ML-300

VRA 1 HFZ-300 & Triple A Bar & Grill Vol#: 1

99V-5407 Laser Light Show

VRA 1 HFZ-300 & Discount Music Center Vol#: 1

99V-5525

VRA 1 HFZ-300 & Laser Safety Officer Vol#: 1

00D-0053 Reprocessing&Reuse of Single-Use Devices/Risk Categorization

C 2 Medical Devive Consultant, Inc Vol#: 1

00N-0088 Psychiatric & Behavioral Disturbances associated w/Dementia

C 12 Alzheimer's Association Vol#: 1

00N-0352 Status of Useful written prescription drug info for Patients

C 1 Public Citizen's Health Research Group Vol#: 1

00P-0499 Review/Act on SKB '132 Form C & '423 Form A patent for NDA20

C 1 SmithKline Beecham Corporation Vol#: 1

00P-1210 Restrict Sale of Coal Tar-Containing Products

ACK 1 HFA-305 Vol#: 1

CP 1 Occupational Knowledge International Vol#: 1

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

ACK 1 HFA-305 Vol#: 1

CP 1 Center for Food Safety Vol#: 1

00V-0570 Laser Light Show

VRA 1 HFZ-300 & Pulse Laser Productions, LLC Vol#: 1

00V-0724 Laser Light Show, Laser Art Series

VRA 1 HFZ-300 & Mac Shine Laser Art Production Vol#: 1