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 June 13, 2002

TABLE OF CONTENTS

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97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container *
01A-0375 Preempt PA Regulations on Human Specimens for Testing *
02N-0169 Combination Products Containing Live Cellular Components *
02P-0270 Suitability Petition for Hydrocodone Bitartrate/Ibuprofen 5 *

84N-0102 Orphan Product Designations

LST 99 Cumulative list through 12/01 Vol#: 4

NAD 16 Vol#: 4

95N-0253 Sale & Distribution Cigarettes protect children/adolescents

CA 3199 David Tom, M. D. Vol#: 5019

CA 3200 Donna Corcino Vol#: 5019

CA 3201 Boy J. Judd Vol#: 5019

CA 3202 Christina King Vol#: 5019

CA 3203 Kevin M. Shiramizu Vol#: 5019

CA 3204 Patrick C. Holland Vol#: 5019

CA 3205 Jason T. Wang Vol#: 5019

CA 3206 Hyewon Jun Vol#: 5019

CA 3207 Sonia M. Patel Vol#: 5019

CA 3208 Ann A. Sato Vol#: 5019

CA 3209 Nick Urciuoli Vol#: 5019

CA 3210 Faith Kull Vol#: 5019

CA 3211 Marisha Chinsley Vol#: 5019

CA 3212 Amanda Maxwell Vol#: 5019

CA 3213 Susan Fennes Vol#: 5019

CA 3214 Nita Libnhlan Vol#: 5019

CA 3215 Angela R. Musella Vol#: 5019

CA 3216 Marlene Yates, R. N. Vol#: 5019

CA 3217 William L. Thomas, Jr. Vol#: 5019

CA 3218 Donald Hayes Vol#: 5019

CA 3219 Arpita Shah Vol#: 5019

CA 3220 Lolita Verny Vol#: 5019

CA 3221 Sejal Diesai Vol#: 5019

CA 3222 Leticia Reyes Vol#: 5019

CA 3223 Heeral Melita Vol#: 5019

CA 3224 Reena Shuh Vol#: 5019

CA 3225 Sharon Blanchard Vol#: 5019

CA 3226 Tina Thomas Vol#: 5019

CA 3227 Cristal Xavier Vol#: 5019

CA 3228 Deepa Doshi Vol#: 5019

CA 3229 Amand Patel Vol#: 5019

CA 3230 Nadia Vizueta Vol#: 5019

CA 3231 Jennifer Nawracey Vol#: 5019

CA 3232 Katy Koufonihalis Vol#: 5019

CA 3233 Kinal Patel Vol#: 5019

CA 3234 Walter Meyers Vol#: 5019

CA 3235 Jennifer Olas Vol#: 5019

CA 3236 Lisa Borja Vol#: 5019

CA 3237 John Rutledge Vol#: 5019

CA 3238 Angela Roberts Vol#: 5019

CA 3239 Heather Campbell Vol#: 5019

CA 3240 Ammy Patel Vol#: 5019

CA 3241 Mike Woliansky Vol#: 5019

CA 3242 Jason Wu Vol#: 5019

CA 3243 Elnaz Firoz Vol#: 5019

CA 3244 Charisa Labe Vol#: 5019

CA 3245 Nelson Nerming Vol#: 5019

CA 3246 Les Hermall Vol#: 5019

CA 3247 Elaina DaSilva Vol#: 5019

CA 3248 Urvesh Soni Vol#: 5019

CA 3249 Ratiman Odewale Vol#: 5019

CA 3250 Erika Naftalis Vol#: 5019

CA 3251 Sharon Ng Vol#: 5019

CA 3252 Tennelle Norman Vol#: 5019

CA 3253 Raalupi Overby Vol#: 5019

CA 3254 Christine Nunes Vol#: 5019

CA 3255 Alec Nacion Vol#: 5019

CA 3256 Micheal Nazmy, Jr. Vol#: 5019

CA 3257 Constance Murray Vol#: 5019

CA 3258 Andy Omello Vol#: 5019

CA 3259 Jenika Brackins Vol#: 5019

CA 3260 Liz Rechy Vol#: 5019

CA 3261 Shanicqua Stallworth Vol#: 5019

CA 3262 Janelle Ogura Vol#: 5019

CA 3263 Matthew Overberger Vol#: 5019

CA 3264 Claire O'Grady Vol#: 5019

CA 3265 Maria Orozco Vol#: 5019

CA 3266 Joan Osoteo Vol#: 5019

CA 3267 Lauren O'Shea Vol#: 5019

CA 3269 Uguma Okwausa Vol#: 5019

CA 3270 Katy Hartley Vol#: 5019

CA 3271 Jared M. Misah Vol#: 5019

CA 3272 Diana Cammarata Vol#: 5019

CA 3273 Bianca Ruffin Vol#: 5019

CA 3274 Mike Ennis Vol#: 5019

CA 3275 Ari Kaminsky Vol#: 5019

CA 3276 Jeffrey E. Corry Vol#: 5019

CA 3277 Kelly Kappelman Vol#: 5019

CA 3278 Ashley Parker Vol#: 5019

CA 3279 Ladaschke Appleuehite Vol#: 5019

CA 3280 Rev. Terry Nelson Vol#: 5019

CA 3281 (Jeannie) Trinh Tran Vol#: 5019

CA 3282 Stephanie Haker Vol#: 5019

CA 3283 Adrienne Helms Vol#: 5019

CA 3284 Molly Bau Vol#: 5019

CA 3285 Jacob Herson Vol#: 5019

CA 3286 Di Damy Vol#: 5019

CA 3287 Jason Humcock Vol#: 5019

CA 3288 Saima Baig Vol#: 5019

CA 3289 Monica Jorge Vol#: 5019

CA 3290 Diana Perez Vol#: 5019

CA 3291 Jeanne-Marie Dill Vol#: 5019

CA 3292 Matt Drischire Vol#: 5019

CA 3293 Jessica Curtin Vol#: 5019

CA 3294 Andrew Keen Vol#: 5019

CA 3295 Danielle Stulman Vol#: 5019

CA 3296 Shawntia Martin Vol#: 5019

CA 3297 Sadia Sayeed Vol#: 5019

CA 3298 Brian Hilliard Vol#: 5019

CA 3299 Tim Scholl Vol#: 5020

CA 3300 Judy Jeanes Vol#: 5020

CA 3301 Heidi Veale Vol#: 5020

CA 3302 Christopher Arnold Vol#: 5020

CA 3303 Katie Skiff Vol#: 5020

CA 3304 Fernando Celorio Vol#: 5020

CA 3305 George McNeil Vol#: 5020

CA 3306 Megan Latter Vol#: 5020

CA 3307 Whitney Wallace Vol#: 5020

CA 3308 Holly Doggett Vol#: 5020

CA 3309 Charles R. Wolfe Vol#: 5020

CA 3310 Steve Gray Vol#: 5020

CA 3311 Glenn F. Alcorn Vol#: 5020

CA 3312 Katie A. Walnetski Vol#: 5020

CA 3313 Patrice Aaron Vol#: 5020

CA 3314 Cecilia M. Kouns Vol#: 5020

CA 3315 Bruce Crowther Vol#: 5020

CA 3316 James Blazino Vol#: 5020

CA 3317 Mary B. Greeley Vol#: 5020

CA 3318 Dean Hokel Vol#: 5020

CA 3319 Linda Deckard Vol#: 5020

CA 3320 Louis R. Gilbert, Jr. Vol#: 5020

CA 3321 Robert H. Jones Vol#: 5020

CA 3322 T. S. Likins Vol#: 5020

CA 3323 Kyle McGraw Vol#: 5020

CA 3324 Larry Lee Vol#: 5020

CA 3325 Larry Saunders Vol#: 5020

CA 3326 Gary R. Barnard Vol#: 5020

CA 3327 Lonnie J. Bevens, II Vol#: 5020

CA 3328 Jim McGraw Vol#: 5020

CA 3329 Bart Brasikor Vol#: 5020

CA 3330 Roger C. Bray Vol#: 5020

CA 3331 John D. Smith Vol#: 5020

CA 3332 Thomas D. Belisle Vol#: 5020

CA 3333 Eugene T. Cheatwood Vol#: 5020

CA 3334 Stewart G. Davis Vol#: 5020

CA 3335 Karissa Rodgers Vol#: 5020

CA 3336 Mike Maberry Vol#: 5020

CA 3337 George Rickstrew Vol#: 5020

CA 3338 Dwight D. Christie Vol#: 5020

CA 3339 Thomas M. Coutee Vol#: 5020

CA 3340 Patrick McMahon Vol#: 5020

CA 3341 Harry C. Stonebraker, Jr. Vol#: 5020

CA 3342 LaVela Sullivan Vol#: 5020

CA 3343 Barry T. Sullivan Vol#: 5020

CA 3344 John J. McNamara Vol#: 5020

CA 3345 James M. Tyler Vol#: 5020

CA 3346 James R. Edwards Vol#: 5020

CA 3347 Janice C. Toles Vol#: 5020

CA 3348 William G. Riggs Vol#: 5020

CA 3349 Rosemarie Toth Vol#: 5020

CA 3350 Mike Boggers Vol#: 5020

CA 3351 Ronda J. Hornick Vol#: 5020

CA 3352 Marvin Hauschild Vol#: 5020

CA 3353 Curt Wilkerson Vol#: 5020

CA 3354 Brandi A. McCure Vol#: 5020

CA 3355 Micheal Kermashek Vol#: 5020

CA 3356 Richard Tiler Vol#: 5020

CA 3357 Mike Smith Vol#: 5020

CA 3358 Beverly Coutee Vol#: 5020

CA 3359 Terry V. Smalley Vol#: 5020

CA 3360 William M. Tarver, Jr. Vol#: 5020

CA 3361 James Flath Vol#: 5020

CA 3362 Jimmy Langley Vol#: 5020

CA 3363 William Langley Vol#: 5020

CA 3364 Larry Cody Vol#: 5020

CA 3365 David T. Moore Vol#: 5020

CA 3366 John B. Deckard Vol#: 5020

CA 3367 Barry K. Stockton Vol#: 5020

CA 3368 Ken Bell Vol#: 5020

CA 3369 Stephen Kirkpatrick Vol#: 5020

CA 3370 Randy Shepherd Vol#: 5020

CA 3371 Steven Gadington Vol#: 5020

CA 3372 Mike Hawkins Vol#: 5020

CA 3373 David Pieke Vol#: 5020

CA 3374 Matt Hawkins Vol#: 5020

CA 3375 Sidney Blanchard Vol#: 5020

CA 3376 Mike Jenkins Vol#: 5020

CA 3377 Kevin DeLeon Vol#: 5020

CA 3378 Wayne H. Shadwick Vol#: 5020

CA 3379 Betty Guillen Vol#: 5020

CA 3380 Jason Bakich Vol#: 5020

CA 3381 Rennon Kuykendall Vol#: 5020

CA 3382 Micheal L. Goldstein Vol#: 5020

CA 3383 Kevin Proctor Vol#: 5020

CA 3384 Rob Hegg Vol#: 5020

CA 3385 Colleen M. Paintee Vol#: 5020

CA 3386 Richard A. Kirkendall Vol#: 5020

CA 3387 Chuck Holden Vol#: 5020

CA 3388 Shaun Weldo Vol#: 5020

CA 3389 Ernest L. Garner Vol#: 5020

CA 3390 Lester Smith Vol#: 5020

CA 3391 Herman R. Gros, Jr. Vol#: 5020

CA 3392 Janice Johnson Vol#: 5020

CA 3393 William Mercer Vol#: 5020

CA 3394 David Mercer Vol#: 5020

CA 3395 Gary M. Staubs, Jr. Vol#: 5020

CA 3396 Micheal H. Gilbert Vol#: 5020

CA 3397 Jimmy Cleveland, Jr. Vol#: 5020

CA 3398 Joey Heinemann Vol#: 5020

97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container

C 9635 American Lung Assn. Vol#: 201

01A-0375 Preempt PA Regulations on Human Specimens for Testing

C 1 Matria Healthcare Vol#: 1

02N-0169 Combination Products Containing Live Cellular Components

APE 9 Advanced Tissure Sciences, Inc. Vol#: 2

APE 10 Healthpoint, Ltd. Vol#: 1

APE 11 Advaced Tissue Sciences, Inc. Vol#: 2

APE 12 AdvaMed Vol#: 2

APE 13 Roger Williamsc Medical Center Vol#: 2

APE 14 Genzyme Corporation Vol#: 2

APE 15 Ortec International, Inc. Vol#: 2

SUP 1 Georgia Institute of Technology Vol#: 2

02P-0270 Suitability Petition for Hydrocodone Bitartrate/Ibuprofen 5

ACK 1 HFA-305 Vol#: 1

CP 1 SciRegs Vol#: 1

02V-0165 Laser Light Show

VRA 1 HFZ-300 to Eyelusions Vol#: 1

02V-0182 Laser light show

VRA 1 HFZ-300 to Vision/MCS (Memphis Concert S Vol#: 1

02V-0183 Laser Light Show

VRA 1 HFZ-300 to Funzalosound Vol#: 1

02V-0185

VRA 1 HFZ-300 to Creative Teen Concepts Inc db Vol#: 1

02V-0188

VRA 1 HFZ-300 to Shore Lanes, Inc. Vol#: 1

02V-0196

VRA 1 HFZ-300 to Pure - Torbati Enterprises Vol#: 1

02V-0197

VRA 1 HFZ-300 to TKO Sound Vol#: 1

02V-0223

VRA 1 HFZ-300 to Us and Them Vol#: 1

02V-0224

VRA 1 HFZ-300 to Q-Peak, Inc. Vol#: 1

02V-0269 Laser light show

ACK 1 HFA-305 Vol#: 1

VAR 1 Telexport, Inc. (TEI) Vol#: 1