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 2, 1999

Table of Contents

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

[FDA DOCKETS PAGE][FDA HOME PAGE]

 
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
98D-0545 Recommendations/Collecting Red Blood Cells/Auto. Apheresis *
98D-1171 Platelet Testing & Evaluation of Platelet Substitute Product *
98N-1038 Irradiation in the production, processing, &handling of food *
99M-2551 PMA TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesi *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary

LET 3731 Vitaceutical Labs Vol#: 24

LET 3732 Vitaceutical Labs Vol#: 24

LET 3733 Vitaceutical Labs Vol#: 24

LET 3734 Vitaceutical Labs Vol#: 24

LET 3735 Vitaceutical Labs Vol#: 24

LET 3736 Vitaceutical Labs Vol#: 24

LET 3737 Vitaceutical Labs Vol#: 24

LET 3738 Vitaceutical Labs Vol#: 24

LET 3739 Vitaceutical Labs Vol#: 24

LET 3740 Vitaceutical Labs Vol#: 24

LET 3741 Vitaceutical Labs Vol#: 24

LET 3742 Vitaceutical Labs Vol#: 24

LET 3743 Vitaceutical Labs Vol#: 24

LET 3744 Leiner Health Products Vol#: 24

LET 3745 Leiner Health Products Vol#: 24

LET 3746 Leiner Health Products Vol#: 24

LET 3747 Leiner Health Products Vol#: 24

LET 3748 Nature's Way Products Inc Vol#: 24

LET 3749 The Winning Combination Vol#: 24

LET 3750 Intelligent Nutrients Vol#: 24

LET 3751 Intelligent Nutrients Vol#: 24

LET 3752 Intelligent Nutrients Vol#: 24

LET 3753 Tsumura & Co Vol#: 24

LET 3754 Tsumura & Co Vol#: 24

LET 3755 Tsumura & Co Vol#: 24

LET 3756 Tsumura & Co Vol#: 24

LET 3757 Tsumura & Co Vol#: 24

LET 3758 Tsumura & Co Vol#: 24

LET 3759 Tsumura & Co Vol#: 24

LET 3760 Vitamer, Div of Anabolic Inc Vol#: 24

LET 3761 Tsumura & Co Vol#: 24

LET 3762 Vitaceutical Labs Vol#: 24

LET 3763 Source Naturals Vol#: 24

LET 3764 Source Naturals Vol#: 24

LET 3765 Source Naturals Vol#: 24

LET 3766 Source Naturals Vol#: 24

LET 3767 Herb Pharm Vol#: 24

LET 3768 Nature's Way Products Inc Vol#: 24

LET 3769 Nature's Way Products Inc Vol#: 24

LET 3770 Nature's Way Products Inc Vol#: 24

98D-0545 Recommendations/Collecting Red Blood Cells/Auto. Apheresis

SUP 1 Haemonetics Corporation Vol#: 1

98D-1171 Platelet Testing & Evaluation of Platelet Substitute Product

C 2 America's Blood Centers Vol#: 1

C 3 Medsep Corporation Vol#: 1

C 4 Baxter Healthcare Corporation Vol#: 1

C 5 Puget Sound Blood Center Vol#: 1

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

C 4417 Miriam Dyak Vol#: 109

C 4418 Joshua Hedgepeth Vol#: 109

C 4419 Kathleen A. Geory Vol#: 109

C 4420 Marie C. Fahnert Vol#: 109

C 4421 Marion C. Hesselgrave Vol#: 109

C 4422 Bette Andresen Vol#: 109

C 4423 Lawrence Storm Vol#: 109

C 4424 Pamela Jane Storm Vol#: 109

C 4425 Michael Crawley Vol#: 109

C 4426 Margaret Yeoman Vol#: 109

C 4427 Debra Simon Vol#: 109

C 4428 Arcana Pharmacy Vol#: 109

C 4429 Robert C. DuPont Vol#: 109

C 4430 Joanna E. Schnarr Vol#: 109

C 4431 Judith Martin Vol#: 109

C 4432 Elizabeth Dewreede Vol#: 109

C 4433 Frederic G. Couvrette Vol#: 109

C 4434 Ana Vollmann Vol#: 109

C 4435 Betty Quick Vol#: 109

C 4436 A. Georgiou Vol#: 109

C 4437 Robert & Virginia Freeman Vol#: 109

C 4438 Darci Andresen Vol#: 109

C 4439 Kiplin D. Chavis Vol#: 109

C 4440 Michael Reynolds Vol#: 109

C 4441 Glayol Sahba, M.D. Vol#: 109

C 4442 N. P. Vol#: 109

C 4443 Max Arnold Vol#: 109

C 4444 Julie E. Snider & Linda D. Deos Vol#: 109

C 4445 Stephen Barton Vol#: 109

C 4446 Ellen Gray Vol#: 110

C 4447 John C. P. Vol#: 110

C 4448 Gwen Turner Vol#: 110

C 4449 Everett Holt King Vol#: 110

C 4450 Tom Weidenkopf Vol#: 110

C 4451 Marsha Champlin Vol#: 110

C 4452 Todd A. Malfa Vol#: 110

C 4453 Peg Pucino Vol#: 110

C 4454 Tom Henderson Vol#: 110

C 4455 Lynn Pruzun Vol#: 110

C 4456 K. James Vol#: 110

C 4457 Elizabeth C. Parker Vol#: 110

C 4458 Jeannie S. Cheever Vol#: 110

C 4459 Daniel Cantor Vol#: 110

C 4460 Dana Cunningham Vol#: 110

C 4461 Marion C. Hesselgrave Vol#: 110

C 4462 Wayne & Tina Moody Vol#: 110

C 4463 William B. & Ellie Siegel Vol#: 110

C 4464 Bill Mears Vol#: 110

C 4465 Deborah Levine Vol#: 110

C 4466 Rachel Rose Vol#: 110

C 4467 Todd Noyes Vol#: 110

C 4468 Russell M. Pirkot Vol#: 110

C 4469 Jennifer Reimenscheider Vol#: 110

C 4470 Linda Mystedt Vol#: 110

C 4471 Laura Elder Vol#: 110

C 4472 Marilyn Peirine Vol#: 110

C 4473 Kristi Arena Vol#: 110

C 4474 Tom Georginis, Ph.D. Vol#: 110

C 4475 Bea Pirro Vol#: 110

C 4476 Matt Holland Vol#: 110

C 4477 Bluelight Enterprises Vol#: 110

C 4478 Mary Denise Bozman Vol#: 110

C 4479 Bob Wallace Vol#: 110

C 4480 Martin Stein Vol#: 110

C 4481 Ana Vollmann Vol#: 110

C 4482 Sally Lacquiee Vol#: 110

C 4483 J. StJames Vol#: 110

C 4484 Pam Frye Vol#: 110

C 4485 illegible Vol#: 110

C 4486 Gayle Hynding Vol#: 110

C 4487 Susan Wothers, M.S. MFT Vol#: 110

C 4488 Emily Koel, Ph.D. Vol#: 110

C 4489 Gail Imamura Vol#: 110

C 4490 Carol DeDecker Vol#: 110

C 4491 Michael Sobiloff Vol#: 110

C 4492 Marilyn B. Vol#: 110

C 4493 David Elisch Vol#: 110

C 4494 Peter Stone Vol#: 110

C 4495 Joann Locke Vol#: 110

C 4496 Jessica Chandler Vol#: 110

C 4497 Judith Martin Vol#: 110

C 4498 Elizabeth Dewreede Vol#: 110

C 4499 Mary & Raymond Sell Vol#: 110

C 4500 Pauline I. & Arthur O. Washburn, Ph.D. Vol#: 110

C 4501 Form Letter Count 50 Vol#: 111

C 4502 Form Letter Count 15 Vol#: 112

99H-2273 Civil Money Penalty;J S R Enterprises Inc,dba Hi-Way Service

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2386 Civil Money Penalty;Friendly Express Inc,dba Friendly Expres

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2387 Civil Money Penalty;Ratliff Grocery Inc,dba Ratliff Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2389 Civil Money Penalty;Red Hed Oil Co,dba Redi Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2390 Civil Money Penalty;CVS Revco D S Inc,dba CVS Pharmacy #4575

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2391 Civil Money Penalty;CVS Revco D S Inc,dba CVS Pharmacy #437

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2392 Civil Money Penalty;Robinson Property Group, Ltd Partnership

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2393 Civil Money Penalty;Friendly Express Inc,dba Friendly Expres

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2394

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2395 Civil Money Penalty;Skyway Inc,dba Sky Mart Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2396 Civil Money Penalty;Flying J Inc,dba Flying J Travel Plaza

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2397 Civil Money Penalty;Leigh Enterprises Ltd,dba Melrose Shell

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2398 Civil Money Penalty;G & M Service Ctr Inc,dba G & M Serice

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2399 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-2400 Civil Money Penalty;Daniel W Rose Sr,dba First Ave. Curb Sto

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2401 Civil Money Penalty;T & J Food Mart Inc,dba T & G Food Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2402 Civil Money Penalty;Shailesh Dave,dba Fast Fuel #23

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2403 Civil Money Penalty;Martha Perdomo,dba El Valle De La Sultan

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2404 Civil Money Penalty;Florence McArdle,dba Hancock Tobacco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2409 Civil Money Penalty;J & C Liquors Ltd,dba Almeida's Liquor

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2410 Civil Money Penalty;Sowell & Sowell Inc,dba Bunky's #2

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2411 Civil Money Penalty;Mattie's of Kinston, Inc,dba C-Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2412 Civil Money Penalty;Cliff Brice Stations Inc,dba Cliff Brice

LET 1 Office of tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2413 Civil Money Penalty; Scott Baldock,dba Eastside Express

LET 1 Office of Tabacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2414 Civil Money Penalty;Pointe Plaza Inc;dba five Points Superma

LET 1 Office of Tabacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2416 Civil Money Penalty;Friendly Express Inc;dba Friendly Expres

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2417 Civil Money Penalty;James David Moore,dba Island Oasis

LET 1 Office of Tabacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2419 Civil Money Penalty;Barbara Halford,dba Jerry's Quik Shop

LET 1 Office of Tabacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2420 Civil Money Penalty;Solitude Beach Inc,dba Parker's Brunswic

LET 1 Office of Tabocco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2421 Civil Money Penalty;Portageville I G A Inc,dba Portageville

LET 1 Office of Tabacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2422 Civil Money Penalty;Manuel Sousa,dba Sousa's Mini-Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2423 Civil Money Penalty;Gowen Investments Inc & Curtis Gowen,dba

LET 1 Office Toabacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2424 Civil Money Penalty;Tom Thumb Food Markets,dba Tom Thumb

LET 1 Office of Tabacco Programs Vol#: 1

NPR 1 HHS/FDA/CDER Vol#: 1

99H-2425 Civil Money Penalty;Triton Marketing Inc,dba Triton's Conoco

LET 1 HHS/FDA/CDER Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2426 Civil Money Penalty;Tru-Valu Foods Inc,dba Tru-Valu IGA#3212

LET 1 Office of Tabacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2427 Civil Money Penalty;Truck Inn Richard Williamson Edmond Doug

LET 1 Office of Tabacco Programs Vol#: 1

NPR 1 HHS/FDA/CDER Vol#: 1

99H-2428 Civil Money Penalty;Jerry Mitchell Upshaw,dba Upshaw's Groce

LET 1 Office of Tabacco Programs Vol#: 1

NPR 1 HHS/FDA/CDER Vol#: 1

99H-2429 Civil Money Penalty;7-Eleven Inc,dba 7-Eleven Store #22613

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2430 Civil Money Penalty;Byong June Lee,dba Palm Springs Liquor

LET 1 Office of Tobacco Programs Vol#: 1

99H-2431 Civil Money Penalty;David Mayo & Deborah Mayo,dba Dave's Mea

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2432 Civil Money Penalty;Host Ent Inc,dba Wink's Convenient Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2433 Civil Money Penalty;John Sgouromitis,dba Outpost Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2434 Civil Money Penalty;Kathy Kindig,dba Scootch's Tavern

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2435 Civil Money Penalty;Kenneth Story,dba Stan's Food Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2436 Civil Money Penalty;Mike Abdul Jabbar,dba Regal Foods

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2437 Civil Money Penalty;Nick Fong,dba Jelly Donut

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2438 Civil Money Penalty;Rite Aid Corp;dba Rite Aid #2110

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2439 Civil Money Penalty;Shahram Zarrinkouh & Fashid Fadakar

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2440 Civil Money Penalty;T & T Grocery Inc,dba Hometown Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2441 Civil Money Penalty;Walgreen Co, dba Walgreens #3625

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2442 Civil Money Penalty;Wal-Mart Stores Inc,dba Wal-Mart Superce

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2443 Civil Money Penalty;Wal-Mart Stores,dba Wal-Mart Supercenter

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2444 Civil Money Penalty;Lee Foods Inc,dba Piggly Wiggly #44

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99M-2551 PMA TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesi

AAV 1 TMJ Concepts Vol#: 1