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 August 3, 1999

Table of Contents

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

[FDA DOCKETS PAGE][FDA HOME PAGE]

 
78N-0038 Sunscreen Drug Products*
92N-0139 Statement Policy: Foods Derived from New Plant Varieties *
97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container *
98N-0056 Sec 111(b)Pediatric Studies of list of Approved Drugs FDAMA *
98N-0608 Plasma Protein Fraction (Human)/Immune Globulin (Human) *
98N-1038 Irradiation in the production, processing, &handling of food *
98P-0203 Eliminate Forced Molting of Laying Birds *
98P-1123 Suspend request to sponsors of pending & approved new animal *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99N-1737 Clinical Trials for Invest Devices Intended to Treat Threat *
99P-0343 Amiodarone Hydrochloride 400mg Tablets *
99P-1172 Add alatrofloxacin to ped. priority list of approved drugs *
99P-1413 Add xenical (orlistat) to the pediatric priority list. *
99V-2628 Laser Light Show *
99V-2629 Laser Light Show (Gemini Laser Corporation) *
78N-0038 Sunscreen Drug Products

LET 168 HFD-560 to CTFA Vol#: 131

TS 4 CTFA Vol#: 131

92N-0139 Statement Policy: Foods Derived from New Plant Varieties

C 5686 Gail S Fellwazen Vol#: 133

C 5687 Cary Arden Vol#: 133

C 5688 Ginny Caldwell Vol#: 133

C 5689 Jody L Attebery Vol#: 133

C 5690 Linda Cloud Vol#: 133

C 5691 Nate Downey Vol#: 133

C 5692 Consumer Union Vol#: 133

C 5693 Loretto Community Vol#: 133

C 5694 P A Gamble Vol#:

C 5695 E E Vnyhl Vol#: 133

C 5696 Jennifer Sclig Vol#: 133

C 5697 Caitlin A Montgomery Vol#: 133

C 5698 Paul Sheridan Vol#: 133

C 5699 Lorraine Wulfe Vol#: 133

C 5700 John Hone Vol#: 133

C 5701 Neva Anderson Vol#: 133

C 5702 Judy L Shernock Vol#: 133

C 5703 Francesca Finnegan Vol#: 133

C 5704 Jessica Joseph Vol#: 133

C 5705 Linda G Tiso Vol#: 133

C 5706 Daisey Kennedy Vol#: 133

C 5707 Nansea Goldberg Vol#: 133

C 5708 Michaela Boudreaux Vol#: 133

C 5709 Amy Sabala Vol#: 133

C 5710 Adria Skikos Vol#: 133

C 5711 Mark Van der Gaag Vol#: 133

C 5712 Chuck & Judy Schiffli Vol#: 133

C 5713 Linda Hilf Vol#: 133

C 5714 Megan Gardner Vol#: 133

C 5715 Linda Solaya Vol#: 133

C 5716 Beth Montgomery Vol#: 133

C 5717 Corrine McCann & 17 signatures Vol#: 133

C 5718 Karen Grant & 58 signatures Vol#: 133

C 5719 Diane Miller Vol#: 133

C 5720 Judith Salmon Vol#: 133

93N-0044 Intent to Amend Performance Standard; Laser Products

C 34 Picker International, Inc Vol#: 2

97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container

C 9602 Susan Williams Vol#: 197

LET 1 EM, American Lung Assn, American Thoraci Vol#: 197

98N-0044 Effect of dietary supplement on structure/function of body

C 22336 Mabel E. Busch Vol#: 871

C 22337 Illegible Vol#: 871

C 22338 Virginia Armstrong Vol#: 871

C 22339 Lurina Uno Vol#: 871

C 22340 Kelly Yamaura Vol#: 871

C 22341 Evelyn M Hood Vol#: 871

C 22342 Betty Hagen Vol#: 871

C 22343 Coby L. Hanes Vol#: 871

C 22344 Holly Stephens Hanes Vol#: 871

C 22345 Julatte Cowell Vol#: 871

C 22346 Kathleen Osnall Vol#: 871

C 22347 Charles Sullivan Vol#: 871

C 22348 Vicki L. Rucker Vol#: 871

C 22349 David J. Holm Vol#: 871

C 22350 Rebecca A. Score Vol#: 871

C 22351 Rosey Learn Vol#: 871

C 22352 Stephen Carter Vol#: 871

C 22353 Baron V. Goodshield Vol#: 871

98N-0056 Sec 111(b)Pediatric Studies of list of Approved Drugs FDAMA

LET 9 HFD-1 to Hoffman-La Roche Inc. Vol#: 3

LET 10 HFD-1 to Pfizer Inc Vol#: 3

98N-0608 Plasma Protein Fraction (Human)/Immune Globulin (Human)

C 1 CSL Bioplama Vol#: 1

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

C 4503 Claire Sidran Vol#: 113

C 4504 Cecil MacNeille Vol#: 113

C 4505 Joseph Gilmour Vol#: 113

C 4506 M. Colette Chandler Vol#: 113

C 4507 Adria Reed Vol#: 113

C 4508 Helen P. Starnes Vol#: 113

C 4509 Lois Manter Vol#: 113

C 4510 Judith Prevratil Vol#: 113

C 4511 Lois Davis Vol#: 113

C 4512 Susan Quinn Vol#: 113

C 4513 Sigrid Schoh et al Vol#: 113

C 4514 Gerald J. Kirley Vol#: 113

C 4515 Patricia Blouin Renfro Vol#: 113

C 4516 Maribeth Hulsey Vol#: 113

C 4517 Elissa Wadds Vol#: 113

C 4518 Ross Randrup Vol#: 113

C 4519 Lidian A. Rose Vol#: 113

C 4520 Cary Arden Vol#: 113

C 4521 Nancy Boomgaarden Vol#: 113

C 4522 Margaret Ris Vol#: 113

C 4523 The Committee for Sustainable Agricultur Vol#: 113

C 4524 Richard W. Hoffman Vol#: 113

C 4525 Dianne Obernuefemann Vol#: 113

C 4526 Joan Warren Vol#: 113

C 4527 Meand Harpua Vol#: 113

C 4528 Anita Ross M.D. & Scott Hofmann Vol#: 113

C 4529 J. Bush Vol#: 113

C 4530 James McAlpin Vol#: 113

C 4531 Melvina Worman Vol#: 113

C 4532 Ginny Caldwell Vol#: 113

C 4533 Jody L. Attebery Vol#: 113

C 4534 Linda Cloud Vol#: 113

C 4535 Nate Downey Vol#: 113

C 4536 Betty Quick Vol#: 113

C 4537 Jean M. Ilsley Vol#: 113

C 4538 Pat D. Vol#: 113

C 4539 Food Irradiation Network (Japan) Vol#: 113

C 4540 J. R. Manning Vol#: 113

C 4541 Michelle Collins Vol#: 113

C 4542 NEI, Nuclear Energy Institute Vol#: 113

C 4543 Yvonne M. Logan Vol#: 113

C 4544 Karl Mehner Vol#: 113

C 4545 Steve Ilsley Vol#: 113

C 4546 Andrea Singmaster Gladfelter Vol#: 113

98P-0203 Eliminate Forced Molting of Laying Birds

C 1751 Angela Nicholas Vol#: 44

C 1752 Judith A Schielka Vol#: 44

C 1753 Alma Blackwelder Vol#: 44

C 1754 Michele Cella Vol#: 44

C 1755 Shawna Owen Vol#: 44

C 1756 Joelle Lilley Vol#: 44

C 1757 Karen Jo Van Es Vol#: 44

C 1758 Staci Stark Vol#: 44

C 1759 Aura Hanna PhD Vol#: 44

C 1760 Julie L Winner Vol#: 44

C 1761 Jean Fitzell Vol#: 44

C 1762 Amber York Vol#: 44

C 1763 Jim & Linda Yester Vol#: 44

C 1764 Amy L Bottrell Vol#: 44

C 1765 Jodie L Moehlenkamp Vol#: 44

98P-1123 Suspend request to sponsors of pending & approved new animal

LET 2 Animal Health Institute Vol#: 1

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 187 Anesa Miller Vol#: 9

C 188 Stephen M Grochowski Vol#: 9

C 189 Diane T Rehor Vol#: 9

C 190 Dr Katherine Whiter Vol#: 9

C 191 Cheryl Laughlin Vol#: 9

C 192 Karen M Carreras Vol#: 9

C 193 Erin Queenan Vol#: 9

C 194 L Bertold Vol#: 9

C 195 Terry Barman Vol#: 9

C 196 Judith Shields Vol#: 9

C 197 Ms Robin Lester Vol#: 9

C 198 Ms Sas Weber Vol#: 9

C 199 Rebecca Knighton Vol#: 9

C 200 Paul Sheridan Vol#: 9

99H-1949 Civil Money Penalty;Humboldt Foods Inc,dba Piggly Wiggly #44

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-2354 Civil Money Penalty;Dave Jaros,dba Country Cupboard

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2355 Civil Money Penalty;John Nave,dba I-95 Exxon

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2360 Civil Money Penalty;Avanti Petroleum Inc,dba Chippewa Vicker

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2361 Civil Money Penalty;Banna Brothers Inc,dba Leuther's Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2362 Civil Money Penalty;Dan Boyer & Trudy Boyer,dba Haffey's Wes

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2363 Civil Money Penalty;Jerry L Brown & Lexanne Brown,dba Ray's

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2364 Civil Money Penalty;Melissa Ann Bueckers,dba Spinners Bar &

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2365 Civil Money Penalty;Linzie Caldwell,dba Caldwell's Package

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2366 Civil Money Penalty;Central Lakes Cooperative,dba Central La

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2367 Civil Money Penalty;Clements Inc,dba College Drive Exxon

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2368 Civil Money Penalty;Cox Oil Co Inc,dba Little General #27

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2369 Civil Money Penalty;John Cucchi,dba Kingshighway Manchester

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2370 Civil Money Penalty;Alice Hilbert,dba AGA Liquor & Convenien

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2371 Civil Money Penalty;Inner City Oil Co Inc,dba Service Oil Co

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2372 Civil Money Penalty;Kualapuu Market Ltd,dba Maunaloa General

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2373 Civil Money Penalty;Maxi Drug Inc,dba Brooks Pharmacy

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2374 Civil Money Penalty;Bill Mitchell & Ida Mitchell,dba Jackpot

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2375 Civil Money Penalty;N J E Inc,dba Stop & Save

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2376 Civil Money Penalty;Frank O Null,dba Null's Quick Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2377 Civil Money Penalty;Krit Patel,dba Petro Food Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2378 Civil Money Penalty; Rakesh Patel,dba Scottish Tobacco Empor

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2379 Civil Money Penalty;Phil's Corner Inc,dba Phil's Corner Inc

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2380 Civil Money Penalty;Pine Isle Market Ltd,dba Pine Isle Marke

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2381 Civil Money Penalty;Prinsburg Farmers Co-Op,dba Cenex Conven

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2382 Civil Money Penalty;THP Ent Inc,dba Bradford Bestway Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2383 Civil Money Penalty;W G H Inc,dba Hillsboro Drug

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2384 Civil Money Penalty;Wal-Mart Stores Inc,dba Wal-Mart Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2385 Civil Money Penalty;Winder Quality Foods LLC,dba Tri-County

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2446 Civil Money Penalty;7-Eleven Inc,dba 7-Eleven Store #2571

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2447 Civil Money Penalty;Bi-Lo Inc,dba Bi-Lo Inc #169

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2448 Civil Money Penalty;Family Roofing Company,dba Family Shell

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2449 Civil Money Penalty;Gioimo Sports Bar Inc,dba Gioimo's Sport

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2450 Civil Money Penalty;Go-Tane Service Station Inc,dba Mobil

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2451 Civil Money Penalty;Juneau of Fort Collins Inc,dba The Crown

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2452 Civil Money Penalty;Robert Klepaida,dba Munich Hofbrau

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2453 Civil Money Penalty;Lucky Seven Food Stores Inc,dba Lucky Fo

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2454 Civil Money Penalty;Arlene Roelike,dba Pump'N Pantry

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2455 Civil Money Penalty;Small's Inc,dba John's Food Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2456 Civil Money Penalty;Super Mercado Torres Inc,dba Torres 3

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2457 Civil Money Penalty;Zamiri's Arco,dba Arco AM/PM

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99N-0926 Regulations under the Federal Import Milk Act;Agency Inform

NCR 1 Vol#: 1

99N-1737 Clinical Trials for Invest Devices Intended to Treat Threat

ANS 1 HFZ-1 to HIMA Vol#: 1

99P-0343 Amiodarone Hydrochloride 400mg Tablets

PAV 1 HFD-600 to Olsson, Frank & Weeda Vol#: 1

99P-1172 Add alatrofloxacin to ped. priority list of approved drugs

PDN 1 HFD-1 to Pfizer, Inc. Vol#: 1

99P-1413 Add xenical (orlistat) to the pediatric priority list.

PAV 1 HFD-1 to Hoffman-La Roche Inc Vol#: 1

99V-2628 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Eaton Sales & Marketing Vol#: 1

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

ACK 1 HFA-305 Vol#: 1

VAR 1 Gemini Laser Corporation Vol#: 1
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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