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 May 15, 2002

TABLE OF CONTENTS

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90P-0201 Optimum size & Style of print to be used to label OTC Drugs *
99D-5347 Transmission of Zoonoses By Blood and Blood Products *
01P-0315 Withdrawal of product from sale in the US *
01P-0385 ANADA Suitability for Oxytetracycline 300 mg/mL Injection *
02D-0039 Medical Sterilization Packaging Systems *
02N-0062 New Dietary Ingredient Premarket Notification,Info. Collect *
02N-0152 Obtain Timely Pediatric Studies & Adequate Pediatric Labelin *
02P-0225 ANDA for Levorphanol Tartrate Tablets *

90P-0201 Optimum size & Style of print to be used to label OTC Drugs

C 79 Mechanical Servants, Inc. Vol#: 8

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

C 2218 Marian Burk Wood Vol#: 65

C 2219 Vernon Cooley Vol#: 65

C 2220 Idamae Knutson Vol#: 65

C 2221 Jack Altman Vol#: 65

C 2222 Gretchen E. Dunn Vol#: 65

C 2223 Dorothy Klinedinst Vol#: 65

C 2224 L. Stephen Coles, M.D., PhD Vol#: 65

C 2225 Marlene A. Leslie Vol#: 65

C 2226 Elinor Felcher Vol#: 65

C 2227 John W. Hallihan Vol#: 65

C 2228 Doug Zbikowski Vol#: 65

C 2229 Anne Mary Klaprat Vol#: 65

C 2230 Barbara Gosda Vol#: 65

C 2231 Alex Belano Vol#: 65

C 2232 Mary Alice Lynn Vol#: 65

C 2233 Nancy Cook Vol#: 65

C 2234 Diane Coffield Vol#: 65

C 2235 Homer D. Kallsen Vol#: 65

C 2236 Elaine Du Charme Vol#: 65

C 2237 Sandrea C. Hunter Vol#: 65

C 2238 J. Rigney Vol#: 65

C 2239 R.H. Edwards Vol#: 65

C 2240 Joan Dambrackas Vol#: 65

C 2241 Jerry E. & Nadine R. Tucker Vol#: 65

C 2242 Patrick G. Welch Vol#: 65

C 2243 Ann S. Wimber Vol#: 65

C 2244 Thomas J. New Vol#: 65

C 2245 Nora D. Schumacher Vol#: 65

C 2246 Eligible Vol#: 65

C 2247 Alvin B. Rubin Vol#: 65

C 2248 Patricia Sells Vol#: 65

C 2249 Gail Seto Vol#: 65

C 2250 Sophie Greenblast Vol#: 65

C 2251 Corrine G. White Vol#: 65

C 2252 Susan Palmore Vol#: 65

C 2253 David Zeff Vol#: 65

C 2254 Edwin H. Feinberg Vol#: 65

C 2255 Rebecca & Richard Canuteson Vol#: 65

C 2256 Olive H. Detering Vol#: 65

C 2257 Nancy L. Weber Vol#: 65

C 2258 Dorothy A. Bauer Vol#: 65

C 2259 Henry Heipel Vol#: 65

C 2260 Joan E. Schmitz Vol#: 65

C 2261 Paul Frehe Vol#: 65

C 2262 Melody O'Donnell Vol#: 65

C 2263 Judy C. Wiss Vol#: 65

C 2264 M. Bennett Vol#: 65

C 2265 Eugene K. O'Reilly Vol#: 65

C 2266 Deborah E. Boots Vol#: 65

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

CA 2199 Andrea Bowman Vol#: 5009

CA 2200 Lueida Liperobi Vol#: 5009

CA 2201 Osa Atoe Vol#: 5009

CA 2202 Ryan Pugh Vol#: 5009

CA 2203 Pam Gross Vol#: 5009

CA 2204 Monique Jenkins Vol#: 5009

CA 2205 Lydia Boyko Vol#: 5009

CA 2206 Allison Pryor Vol#: 5009

CA 2207 Sarah Phillips Vol#: 5009

CA 2208 Meghan Collins Vol#: 5009

CA 2209 Dionne Paul Vol#: 5009

CA 2210 Chad Maddox Vol#: 5009

CA 2211 Patrick Rooney Vol#: 5009

CA 2212 Jennifer R. Hall Vol#: 5009

CA 2213 Toni Burr Vol#: 5009

CA 2214 Khalil Salem Vol#: 5009

CA 2215 Eugene Smith Vol#: 5009

CA 2216 Jackie Lynch Vol#: 5009

CA 2217 Gerard Aleantara Vol#: 5009

CA 2218 Adrienne R. Hoorini Vol#: 5009

CA 2219 Gail Huangwalktag Vol#: 5009

CA 2220 Kristin A. Dorn Vol#: 5009

CA 2221 Jeremy Bergman Vol#: 5009

CA 2222 Sahada Vol#: 5009

CA 2223 Chris Austin Vol#: 5009

CA 2224 Micheal Stodghill Vol#: 5009

CA 2225 Samantha Alkert Vol#: 5009

CA 2226 Malisha N. Thompson Vol#: 5009

CA 2227 Lois Wright Vol#: 5009

CA 2228 Tatiara Wall Vol#: 5009

CA 2229 Shawlana Martin Vol#: 5009

CA 2230 Tamara Valdes Vol#: 5009

CA 2231 Gwynn Eckert Vol#: 5009

CA 2232 Jamie Jikaku Vol#: 5009

CA 2233 Brian Bowers Vol#: 5009

CA 2234 Sammy Lee Vol#: 5009

CA 2235 Thomas Dryworld Vol#: 5009

CA 2236 Katie Schneider Vol#: 5009

CA 2237 Philip Heul Vol#: 5009

CA 2238 Samuel Taye Vol#: 5009

CA 2239 Nicole Sanderson Vol#: 5009

CA 2240 Kathryn Norton Vol#: 5009

CA 2241 Lauren Johns Vol#: 5009

CA 2242 Shiree Marteur Vol#: 5009

CA 2243 Danielle Swan Vol#: 5009

CA 2244 David C. Pugh Vol#: 5009

CA 2245 Leila Paige Vol#: 5009

CA 2246 Candace Bean Vol#: 5009

CA 2247 Dawn Placek Vol#: 5009

CA 2248 Rob Sides Vol#: 5009

CA 2249 Jenny Sleezer Vol#: 5009

CA 2250 Whitney Wallace Vol#: 5009

CA 2251 Mike Richardson Vol#: 5009

CA 2252 Melinda Leclbetter Vol#: 5009

CA 2253 Dayna C. Brown Vol#: 5009

CA 2254 Mike Roth Vol#: 5009

CA 2255 DaToya Murrell Vol#: 5009

CA 2256 Rickey Lang Vol#: 5009

CA 2257 Fernanda Wario Vol#: 5009

CA 2258 Michelas Richardson Vol#: 5009

CA 2259 Kristen Maupulos Vol#: 5009

CA 2260 Chrissy Newman Vol#: 5009

CA 2261 Chris Martel Vol#: 5009

CA 2262 Dick Bell Vol#: 5009

CA 2263 Dallas McGinn Vol#: 5009

CA 2264 Jason Paul Vol#: 5009

CA 2265 Eric Adams Vol#: 5009

CA 2266 Ryan Schulz Vol#: 5009

CA 2267 Carol Silva Vol#: 5009

CA 2268 Jason Sadala Vol#: 5009

CA 2269 Tore Wiik Vol#: 5009

CA 2270 Steven Molder Vol#: 5009

CA 2271 Alicia Armstrong Vol#: 5009

CA 2272 Elizabeth Mullins Vol#: 5009

CA 2273 Elizabeth Motley Vol#: 5009

CA 2274 Steve Shepherd Vol#: 5009

CA 2275 Mark Gardina Vol#: 5009

CA 2276 Emily Pause Vol#: 5009

CA 2277 N. Michelle Huyman Vol#: 5009

CA 2278 Adam Delunn Vol#: 5009

CA 2279 Cherry Clayton Vol#: 5009

CA 2280 Katie Slawson Vol#: 5009

CA 2281 Lori Shelton Vol#: 5009

CA 2282 Kim Bryant Vol#: 5009

CA 2283 Kenya Chiblack Vol#: 5009

CA 2284 Charles Wedsa Vol#: 5009

CA 2285 Scott Perkins Vol#: 5009

CA 2286 Hector Mujica Vol#: 5009

CA 2287 Rick Muntiel Vol#: 5009

CA 2288 Amber White Vol#: 5009

CA 2289 Patty Mahan Vol#: 5009

CA 2290 Chris Nottingham Vol#: 5009

CA 2291 Shark Bird Vol#: 5009

CA 2292 Eugene Anthony Vol#: 5009

CA 2293 Illegible Vol#: 5009

CA 2294 Paula Mills, R. N. Vol#: 5009

CA 2295 Linda Span Vol#: 5009

CA 2296 Todd L. Houser Vol#: 5009

CA 2297 Eric L. Livers, M. D. Vol#: 5009

CA 2298 Janie Wessmer Vol#: 5009

CA 2299 Jennifer Wiedman Vol#: 5010

CA 2300 Elisha D. Burchett Vol#: 5010

CA 2301 Stephanie King Vol#: 5010

CA 2302 Johnathan Randles Vol#: 5010

CA 2303 Jonathan Covender Vol#: 5010

CA 2304 Kristen Sirk Vol#: 5010

CA 2305 Dianna Rae Halcomb Vol#: 5010

CA 2306 Donald Peck Vol#: 5010

CA 2307 Leslie Lanham Vol#: 5010

CA 2308 David Stephenson Vol#: 5010

CA 2309 Clarissa Carr Vol#: 5010

CA 2310 John Brannon Vol#: 5010

CA 2311 Jeremy Walker Vol#: 5010

CA 2312 Felicia Brown Vol#: 5010

CA 2313 Thomas Miller Vol#: 5010

CA 2314 Flora Hayes Vol#: 5010

CA 2315 Charles O. DeGarms Vol#: 5010

CA 2316 Dr. Barton Hershfield Vol#: 5010

CA 2317 Karen Hirshfield Vol#: 5010

CA 2318 Stephanie Patterson Vol#: 5010

CA 2319 Jeremy Chamberlin Vol#: 5010

CA 2320 Henry Schoolcroft Vol#: 5010

CA 2321 Scotty Lane Boggs Vol#: 5010

CA 2322 Harry E. Williams, Jr. Vol#: 5010

CA 2323 Gregory Brown Vol#: 5010

CA 2324 Richard Runnion Vol#: 5010

CA 2325 Jeffrey Cogar Vol#: 5010

CA 2326 Bobbi Summers Vol#: 5010

CA 2327 Andrea Butler Vol#: 5010

CA 2328 Jeremy Brown Vol#: 5010

CA 2329 Kelsey Higginbotham Vol#: 5010

CA 2330 Allene K. Brown Vol#: 5010

CA 2331 Amanda Taylor Vol#: 5010

CA 2332 Jack Sherman Vol#: 5010

CA 2333 Lori Ferre Dee Vol#: 5010

CA 2334 Chrissy Foster Vol#: 5010

CA 2335 Jessica Ramsey Vol#: 5010

CA 2336 Nadeema Boggs Vol#: 5010

CA 2337 Chris Underwood Vol#: 5010

CA 2338 J. R. Harper Vol#: 5010

CA 2339 Jean Allen Vol#: 5010

CA 2340 Katherine S. Brannon Vol#: 5010

CA 2341 Sophie Lopez Vol#: 5010

CA 2342 Angela Ballato Vol#: 5010

CA 2343 Josephine Lopez Vol#: 5010

CA 2344 Richard Boyd Vol#: 5010

CA 2345 Cathy Lee Vol#: 5010

CA 2346 Mindi Rees Vol#: 5010

CA 2347 Dr. Rick Latos Vol#: 5010

CA 2348 Jeremy Gray Vol#: 5010

CA 2349 Dr. James W. Gainer, M. D. Vol#: 5010

CA 2350 Charles E. Gray Vol#: 5010

CA 2351 Jacquelyn F. Fortney Vol#: 5010

CA 2352 James C. Stemple Vol#: 5010

CA 2353 Ona Gray Vol#: 5010

CA 2354 Loretta Gray Vol#: 5010

CA 2355 Jeff Williams Vol#: 5010

CA 2356 Joshua Myers Vol#: 5010

CA 2357 Jason L. Freshwater Vol#: 5010

CA 2358 Joshua Jones Vol#: 5010

CA 2359 Annie Rhodes Vol#: 5010

CA 2360 Billy Jack Ward Vol#: 5010

CA 2361 Kristy Frank Vol#: 5010

CA 2362 Jennifer Dwier Vol#: 5010

CA 2363 Amy Pritt Vol#: 5010

CA 2364 Diann Westfall Vol#: 5010

CA 2365 Frank Bennett Vol#: 5010

CA 2366 Amanda Mullins Vol#: 5010

CA 2367 Nathaniel Duffield Vol#: 5010

CA 2368 No Submitter Vol#: 5010

CA 2369 Shannon Marie Keen Vol#: 5010

CA 2370 Katie Walker Vol#: 5010

CA 2371 Ashley Keener Vol#: 5010

CA 2372 Tia Gray Vol#: 5010

CA 2373 Kandy Moore Vol#: 5010

CA 2374 Nancy S. Tonkin Vol#: 5010

CA 2375 Alan Boneri Nelson Vol#: 5010

CA 2376 Debbie Leedy Vol#: 5010

CA 2377 Donnie Friend Vol#: 5010

CA 2378 Dawn Lynn Brown Vol#: 5010

CA 2379 Marguerite A. Demming Vol#: 5010

CA 2380 Terri Richmond Vol#: 5010

CA 2381 Robert H. Fleming Vol#: 5010

CA 2382 Maurice G. & Mildred Weavil Vol#: 5010

CA 2383 Maurice G. & Mildred Weavil Vol#: 5010

CA 2384 Sandy Tucker Vol#: 5010

CA 2385 Joseph E. Elrod, III Vol#: 5010

CA 2386 Mary T. Cooper Vol#: 5010

CA 2387 Nikki Rice Vol#: 5010

CA 2388 Cassidy R. Pyatt Vol#: 5010

CA 2389 Carlyle Blanton Vol#: 5010

CA 2390 Mark Cofield Vol#: 5010

CA 2391 Mrs. Thad W. Tate Vol#: 5010

CA 2392 Anne Sargent Vol#: 5010

CA 2393 D. T. Richards Vol#: 5010

CA 2394 Don Loftis Vol#: 5010

CA 2395 R. R. Millhiser, Sr. Vol#: 5010

CA 2396 Joseph P. Ryan Vol#: 5010

CA 2397 William M. Phillips Vol#: 5010

CA 2398 Wendy Hottle Vol#: 5010

95N-0259 Over the Counter Drug Labeling; Public Hearing

C 25 Mechanical Servants, Inc. Vol#: 13

96N-0420 OTC Human Drugs; Proposed Labeling Requirements

C 1031 Mechanical Servants, Inc. Vol#: 25

98N-0337 Over the counter human drugs labeling requirements

C 12 Mechanical Servants, Inc. Vol#: 8

99D-5347 Transmission of Zoonoses By Blood and Blood Products

C 34 Plasma Protein Therapeutics Assn Vol#: 8

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9751 Jeanne Homme Vol#: 570

C 9752 Phillip Miner Vol#: 570

C 9753 Merlin Bailor Vol#: 570

C 9754 Donna Sebok Vol#: 570

C 9755 Eligible Vol#: 570

C 9756 Lucille DiBattista Vol#: 570

C 9757 Pat J. Axelsen Vol#: 570

C 9758 Cynthia Gelder Vol#: 570

C 9759 Kate Pollack Vol#: 570

C 9760 CSPI et al. Vol#: 570

C 9761 Sandra A. Hutichison Vol#: 570

C 9762 David Maryles Vol#: 570

C 9763 J. Moore Vol#: 570

C 9764 Joe Snock Vol#: 570

C 9765 Terence Anderson Vol#: 570

C 9766 Q. Nguyen Vol#: 570

C 9767 Tom Digan Vol#: 570

C 9768 C. Mojor Vol#: 570

C 9769 Jill Isherwood Vol#: 570

C 9770 Patrick Kennedy Vol#: 570

C 9771 Stacy Rosentha Vol#: 570

C 9772 Wendy Mitchell Vol#: 570

C 9773 Adam Kahn Vol#: 570

C 9774 Amy Rossi Vol#: 570

C 9775 Mike Wiecks Vol#: 570

C 9776 Mike Binder Vol#: 570

C 9777 Michael Youhouse Vol#: 570

C 9778 Michael C. Ferko Vol#: 570

C 9779 Mike Foering Vol#: 570

C 9780 Jennifer Radel Vol#: 570

C 9781 Stefanie Friedman Vol#: 570

C 9782 Leigh Grissman Vol#: 570

C 9783 Tim Mortough Vol#: 570

C 9784 Michael Kitlan Vol#: 570

C 9785 Robert Lynch Vol#: 570

C 9786 Doreen Bryla Vol#: 570

C 9787 Justin Vol#: 570

C 9788 Michael Smith Vol#: 570

C 9789 Ben Norman Vol#: 570

C 9790 Paul Salman Vol#: 570

C 9791 Clayton Hamilton Vol#: 570

C 9792 J. DeNonno Vol#: 570

C 9793 Jesse Munn Vol#: 570

C 9794 John Etchberger Vol#: 570

C 9795 Damian Clawser Vol#: 570

C 9796 Jeremy Martini Vol#: 570

C 9797 Steve Shurgo Vol#: 570

01N-0589 Extralabel Drug Use in Animals

N 2 Vol#: 1

01P-0034 Restaurant Foods Containing Methylcellulose or Carrageenin

LET 3 Ruth Armstrong Vol#: 1

01P-0061 Request to file an ANDA for Ifosfamide for Injection

N 1 Vol#: 1

01P-0190 Fountain Diet Coca-Cola and Bottled Diet Coca-Cola

C 2 Carolyn Quastler Vol#: 1

C 3 Denise Reichert Vol#: 1

C 4 James E. Leeman Vol#: 1

C 5 Geri Davenport Vol#: 1

C 6 Barbara Durfee, L.P.N. Vol#: 1

C 7 Phyllis Paro Vol#: 1

C 8 Stacy Rosenthal Vol#: 1

C 9 Eligible Vol#: 1

C 10 Robert Lynch Vol#: 1

C 11 Paul Salvian Vol#: 1

C 12 Eligible Vol#: 1

C 13 Clayton Hamilton Vol#: 1

C 14 Michael Smith Vol#: 1

C 15 Michael C. Ferko Vol#: 1

C 16 Doreen Bryla Vol#: 1

C 17 Carrie Crowne Vol#: 1

C 18 Michael Youhouse Vol#: 1

C 19 Joshua Moore Vol#: 1

C 20 Joe Snook Vol#: 1

C 21 Jennifer Radel Vol#: 1

C 22 J.D. Bill Vol#: 1

C 23 Tom Murlaugh Vol#: 1

C 24 Patrick Kennedy Vol#: 1

C 25 Leigh Grossman Vol#: 1

C 26 Thomas E. Digan Vol#: 1

C 27 Mike Wiecks Vol#: 1

C 28 J. DeNonro Vol#: 1

C 29 Jeremy Marfini Vol#: 1

C 30 Q. Nguyen Vol#: 1

C 31 David Maryles Vol#: 1

C 32 Carrie Ross Vol#: 1

C 33 Jennifer K. Wood, PhD Vol#: 1

C 34 M. Casery Vol#: 1

C 35 C. Rasol Vol#: 1

C 36 C. Casey Vol#: 1

C 37 C. Munko Vol#: 1

C 38 Bryan Gray Vol#: 1

C 39 F. Blackhall Vol#: 1

C 40 Kristine Walterhouse Vol#: 1

C 41 Diana K. Neal Vol#: 1

C 42 A.P. Jordan Vol#: 1

C 43 D.L. Thompson Vol#: 1

C 44 Kelly Wagner Vol#: 1

C 45 Robert Stouffer Vol#: 1

C 46 Jeremy M. Smith Vol#: 1

C 47 Todd P. Chadman Vol#: 1

C 48 Eligible Vol#: 1

C 49 Charlotte Caldwell Vol#: 1

C 50 Eligible Vol#: 1

C 51 Eligible Vol#: 1

C 52 Amy Rossi Vol#: 1

C 53 Eligible Vol#: 1

C 54 Lauren Innella Vol#: 1

C 55 Michael Kitlan Vol#: 1

C 56 C. Major Vol#: 1

C 57 Damian Clawser Vol#: 1

C 58 Steve Shurgott Vol#: 1

C 59 Mike Foering Vol#: 1

01P-0207 Amend the final regulation on OTC drug labeling content & fo

C 2 Mechanical Servants, Inc. Vol#: 1

01P-0315 Withdrawal of product from sale in the US

LET 2 HFD-7 to Aspire Pharmaceuticals Inc Vol#: 1

01P-0385 ANADA Suitability for Oxytetracycline 300 mg/mL Injection

PDN 1 HFV-1 to Cross Vetpharm Group Ltd. Vol#: 1

02D-0039 Medical Sterilization Packaging Systems

C 4 DePuy Orthopaedics, Inc. Vol#: 1

C 5 Getinge/Castle, Inc. Vol#: 1

02D-0113 Root-Form Endosseous Dental Implants and Abutments

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

02N-0062 New Dietary Ingredient Premarket Notification,Info. Collect

C 1 National Nutritional Foods Assn Vol#: 1

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

NPR 1 Vol#: 1

02N-0152 Obtain Timely Pediatric Studies & Adequate Pediatric Labelin

C 1 National Organization for Rare Disorders Vol#: 1

02P-0225 ANDA for Levorphanol Tartrate Tablets

ACK 1 HFA-305 Vol#: 1

CP 1 Lachman Consultant Services, Inc. Vol#: 1