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 03/13/00

Table of Contents

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

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88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE*
92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992 *
97P-0329 Require Quantitative Labeling of Caffeine Content *
98N-0673 Revisions to Requirements to Blood,Blood Components & Plasma *
99D-4487 Conducting Stability Testing to Support an Expiration Date *
99D-4910 Mammography Quality Standards Act Final Regulations #3 *
99N-4784 Redacted Version of Substantially-Equivalent Premarket Notif *
99N-4955 Amendment of Various Device Regulations*
99P-4613 Revoke the Regulation That Approved Posilac*
00M-0809 P990034; Cellugel Ophthalmic Viscosurgical Device*
00M-0810 P900009/S6; Exogen 2000/Sonic Accelerated Fracture Healing*
00P-1077 Amend Current Reg Banning Sale of Small Turtles *
00P-1084 Diabetes Drugs Troglitazone,rosiglitazone,pioglitazone*
00P-1085 Classify cranial helment in class I,exempt from premarket *
00V-1076 Laser Light Show Mobolazer ML10-200,ML10-300,ML10-300W,ML100 *
88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE

C 70 American Red Cross Vol#: 2

92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992

C 57 American Red Cross Vol#: 3

97P-0329 Require Quantitative Labeling of Caffeine Content

C 238 Center for Science in the Public Interes Vol#: 4

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

C 22404 Laughlin Associates, Inc Vol#: 882

98N-0337 Over the counter human drugs labeling requirements

C 5 Dennis E. Novak, M.D. Vol#: 5

98N-0673 Revisions to Requirements to Blood,Blood Components & Plasma

C 9 ThermoGenesis Corp Vol#: 1

99D-4487 Conducting Stability Testing to Support an Expiration Date

C 2 R. T. Vanderbilt Company, Inc Vol#: 1

99D-4910 Mammography Quality Standards Act Final Regulations #3

C 1 The Breast Center of Tallahassee Vol#: 1

99H-2058 Civil Money Penalty;Bruno's Inc,dba Foodmax #794

CS 1 HFA-305 Vol#: 1

99H-2071 Civil Money Penalty;Selby Dean,dba Powers Crossroads Country

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2094 Civil Money Penalty;Matthew Warner,dba U-Pump-It

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2107 Civil Money Penalty;Potter Foods Inc,dba Sunflower #9038

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2121 Civil Money Penalty;Janet Bankston,dba Janet's Grocery

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2122 Civil Money Penalty;Bear Inc,dba Laker Express

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2181 Civil Money Penalty;Robert E Knight,dba Jumpertown Grocery

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2183 Civil Money Penalty;A Richard Palatino,dba Jane Alden Dairy

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2194 Civil Money Penalty;Kwickie/Flash Foods Inc,dba Flash Foods

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2242 Civil Money Penalty;Pump & Save Inc,dba Pump & Save #736

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2314 Civil Money Penalty; C J C Sales Inc,dba J D's Quick Stop

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2317 Civil Money Penalty;Ghasan Eid,dba Town Mart

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2319 Civil Money Penalty;Friendly Express Inc,dba Friendly Expres

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2322 Civil Money Penalty;Steven Hipes,dba 7-Eleven Food Store

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2324 Civil Money Penalty;Nick Hussain & Rubina Hussain,dba Open

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2325 Civil Money Penalty;Kobal Inc,dba Fall River Texaco

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2461 Civil Money Penalty;Linda Bauer,dba Linda B's Limited

CS 1 HFA-305 Vol#: 1

99H-2462 Civil Money Penalty;Bradley Petroleum Inc,dba Bradley Petrol

CS 1 HFA-305 Vol#: 1

99H-2468 Civil Money Penalty;Glynn's Motor Mart Inc,dba Glynn's Motor

CS 1 HFA-305 Vol#: 1

99H-2498 Civil Money Penalty;50's Cafe Inc,dba Cafe & Bar

CS 1 HFA-305 Vol#: 1

99H-2505 Civil Money Penalty;Howard Swanger & Barbara Swanger,dba Log

CS 1 HFA-305 Vol#: 1

99H-2512 Civil Money Penalty;Robert Jackson,dba Green Park Texaco

CS 1 HFA-305 Vol#: 1

99H-2519 Civil Money Penalty;Pacific Sun Corp,dba Pacific Super Marke

CS 1 HFA-305 Vol#: 1

99H-2524 Civil Money Penalty;L.R.'S Discount Gas & Foods Inc,dba L.R.

CS 1 HFA-305 Vol#: 1

99H-2537 Civil Money Penalty;7-Eleven Inc,dba 7-Eleven Food Store

CS 1 HFA-305 Vol#: 1

99H-2542 Civil Money Penalty;Leonard E. Belcher Incorporated,dba Expr

CS 1 HFA-305 Vol#: 1

99H-2546 Civil Money Penalty;TPI Petroleum Inc,dba Total #4047

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2556 Civil Money Penalty;A&F Superette Inc,dba Carl Superette

CS 1 HFA-305 Vol#: 1

99H-2565 Civil Money Penalty;Joseph K. Goodwin,dba Joey's Mini Mart

CS 1 HFA-305 Vol#: 1

99H-2576 Civil Money Penalty;Rite Aid Corporation,dba Rite Aid #6155

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2580 Civil Money Penalty;Frances Townsend,dba The Country Store

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2583 Civil Money Penalty;Waring Oil Company,dba Interstate Statio

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2592 Civil Money Penalty;Alaaeldin F. Ramadan,dba LI'L Peach #439

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2603 Civil Money Penalty;Lake View Resort Inc,dba Lakeview Resort

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2610 Civil Money Penalty;Cross Roads Curb Market Inc

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2611 Civil Money Penalty;Deborah Nored,dba Dixie Pig Country Stor

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2624 Civil Money Penalty;Richard Brown,dba Brown's General Expres

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2641 Civil Money Penalty;Corley & McClendon Drugs Inc,dba Corley

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2642 Civil Money Penalty;Jimmie Lee Edwards Sr,dba Jimmie's Marke

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2647 Civil Money Penalty;Patricia Maples,dba Second Creek Grocery

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2656 Civil Money Penalty;Mohamed Shuman,dba Quincy Auto Service

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2657 Civil Money Penalty;Speedway Superamerica LLC,dba Superameri

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2667 Civil Money Penalty;SOS Truck Stop Inc,dba Southwind 66

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2677 Civil Money Penalty;Lowe's Food Store Inc,dba Lowe's Food St

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2678 Civil Money Penalty;Mobil Oil Corporation,dba Countryside Mo

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2681 Civil Money Penalty;La International Food Corporation In, db

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

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

C 5 Neal Dunning Associates, Inc Vol#: 1

99N-4955 Amendment of Various Device Regulations

C 1 ASTM Vol#: 1

99P-4613 Revoke the Regulation That Approved Posilac

EMC 1361 Leona & Arnold Kokans Vol#: 15

EMC 1362 Lorrie Ogren Vol#: 15

EMC 1363 Ernie Kuonen Vol#: 15

EMC 1364 Liz Altschule Vol#: 15

EMC 1365 Rik Communication Vol#: 15

EMC 1366 Steve & Miriam Hospodar Vol#: 15

EMC 1367 Steve & Miriam Hospodar Vol#: 15

EMC 1368 Elizabeth F. Winstead Vol#: 15

EMC 1369 Rudy Vol#: 15

EMC 1370 J. L. Singag Vol#: 15

EMC 1371 Dan Hinkley Vol#: 15

EMC 1372 M'Lou Brown Vol#: 15

EMC 1373 Lorriane Cook Vol#: 15

EMC 1374 Margie Jackson Haley Vol#: 15

EMC 1375 David S. Musser Vol#: 15

EMC 1376 Soliman Lawrence Vol#: 15

EMC 1377 Sierra Hollister Vol#: 15

EMC 1378 Karin Wulff Vol#: 15

EMC 1379 Daphne Schwamm Vol#: 15

EMC 1380 Mark Gasaway Vol#: 15

EMC 1381 Sara Wood Vol#: 15

EMC 1382 Victoria Mattingly Vol#: 15

EMC 1383 Philip F. Tomlinson, Ph.D. Vol#: 15

EMC 1384 Bev Chell Vol#: 15

EMC 1385 Nina Narelle Vol#: 16

EMC 1386 Steven Yellin Vol#: 16

EMC 1387 John Revolinski Vol#: 16

EMC 1388 George Foster Vol#: 16

EMC 1389 Cecil Hughart Vol#: 16

EMC 1390 Tracey Rolandelli Vol#: 16

EMC 1391 Thomas & Ulrike Selleck Vol#: 16

EMC 1392 James Corcoran Vol#: 16

EMC 1393 Graham de Freitas Vol#: 16

EMC 1394 Star L. Vol#: 16

EMC 1395 John Scarlata Vol#: 16

EMC 1396 Carol Pedersen Vol#: 16

EMC 1397 Charles Dockins Vol#: 16

EMC 1398 Sherrie Ogren Vol#: 16

EMC 1399 Matt & Suzanna Mullenneaux Vol#: 16

EMC 1400 Terry Shaw Vol#: 16

EMC 1401 Sally M. Smith Vol#: 16

EMC 1402 Gretel (Margaret I. Baacke) Vol#: 16

EMC 1403 Barrett Brown Vol#: 16

EMC 1404 Lawrence Vol#: 16

EMC 1405 Kristin R. Chiari Vol#: 16

EMC 1406 Anna Sagel Vol#: 16

EMC 1407 Jeffrey A. Tennis Vol#: 16

EMC 1408 Mission Possible International Vol#: 16

EMC 1409 David Porter Vol#: 16

EMC 1410 Joshua Podoll Vol#: 16

EMC 1411 Avni Vol#: 16

EMC 1412 Allegheny Defense Project Vol#: 16

EMC 1413 Liane Casten Vol#: 16

EMC 1414 David & Elizabeth Nichols Vol#: 16

EMC 1415 Walter Reifslager III Vol#: 16

EMC 1416 Ellen Reifslager Vol#: 16

EMC 1417 Michael Kubinec Vol#: 16

EMC 1418 Jim Cervelli Vol#: 16

EMC 1419 Cindy Hinkley Vol#: 16

EMC 1420 Alan Kreglow Vol#: 16

EMC 1421 Paul Handelman Vol#: 16

EMC 1422 Sharon Mitchell Vol#: 16

EMC 1423 Orion Walker Vol#: 16

EMC 1424 Norin D. Isquith Vol#: 16

EMC 1425 Magdalene Jaeckel Vol#: 16

EMC 1426 Marlene Vol#: 16

EMC 1427 Harvey & Peggy Vol#: 16

EMC 1428 Jennifer Goldsmith Vol#: 16

EMC 1429 D. Wittman Vol#: 16

EMC 1430 Alison Benson Vol#: 16

EMC 1431 Suzanne Wuerthele, Ph.D. Vol#: 16

EMC 1432 Michael J. Schill Vol#: 16

EMC 1433 Jarvis Jackson Vol#: 16

EMC 1434 Henry Kantrowitz Vol#: 16

00H-0250 Civil Money Penalty;Dean Bacon and Ann Bacon,dba Maurie's

CS 1 HFA-305 Vol#: 1

00H-0307 Civil Money Penalty;Charles Mayo,dba C J'S Exxon

CS 1 HFA-305 Vol#: 1

00H-0544 Civil Money Penalty;O'Rourke's Inc,dba O'Rourkes Restaurant

LET 1 HHS/CDER/FDA Vol#: 1

00H-0545 Civil Money Penalty;Paul's Quick Shop Inc,dba Paul's Quick S

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0546 Civil Money Penalty;Dennis Routh,dba Sheridan Mini Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0547 Civil Money Penalty;Sheehan's Mini Market Inc,dba Sheehan's

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0548 Civil Money Penalty;Kelly Spackman,dba La Tienda

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0549 Civil Money Penalty;Tri-Valley Distributing Inc,dba Montpeli

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0550 Civil Money Penalty;United Oil Marketes inc,dba United Oil #

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0551 Civil Money Penalty;Billy Whittet,dba Whittet's Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0552 Civil Money Penalty;Dan Wilkinson,dba Alberta Chain Saw Sale

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0623 Civil Money Penalty;Chung S Ahn,dba Phir Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0624 Civil Money Penalty;Najah Ayesh,dba Lena's Food & Liquors

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0625 Civil Money Penalty;Thomas L Bassett,dba Bassett's Grocery &

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0626 Civil Money Penalty;Beeline Stores Inc,dba Beeline Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0627 Civil Money Penalty;Buffalo Road Market LLC,dba Buffalo Road

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0628 Civil Money Penalty;Jerry Burt,dba Jerry's Penn Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0629 Civil Money Penalty;Clarendon Food Mart Inc,dba Clarendon Fo

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0630 Civil Money Penalty;Coastal Mart Inc,dba Coastal Mart #7034

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0631 Civil Money Penalty;E-Z Mart Stores Inc,dba E-Z Mart Store #

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0632 Civil Money Penalty;Farris Express Fuels Inc,dba Xpress Fuel

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0633 Civil Money Penalty;Rodney K Frieouf,dba Wakita Station

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0634 Civil Money Penalty;Terianne Graff,dba Finish Line

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0635 Civil Money Penalty;Kean Bros Inc,dba Kean Brothers Inc

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0636 Civil Money Penalty;K-Mart Corp,dba K-Mart Store #7259

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0637 Civil Money Penalty;Lakeview Foods Inc,dba Lakeview Foods

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0638 Civil Money Penalty;Meyers Pharmacy Inc,dba Meyers Pharmacy

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0639 Civil Money Penalty;John P. Modesto,dba Port Carbon Service

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0640 Civil Money Penalty;Oscar Kenny Moore,dba Moore's Auto Servi

LET 1 Office fo Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0641 Civil Money Penalty;Hazel W Nelson,dba England Grocery & Mar

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0642 Civil Money Penalty;Girish Patel,dba Rainbow Motel

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#:

00H-0643 Civil Money Penalty;Pinto Soin,dba 7-Eleven #11542

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0644 Civil Money Penalty;Olympic Oil Co Inc,dba Quick Shop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0645 Civil Money Penalty;Regabec Enterprises Inc,dba Ellis Short

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0646 Civil Money Penalty;Rim Rock Bar & Grill Inc,dba Rim Rock Ba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0647 Civil Money Penalty;Francis Seo and Theresa Seo,dba Byrdland

LET 1 Office fo Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0648 Civil Money Penalty;Al Stecklein and Mary Stecklein,dba AML

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0649 Civil Money Penalty;Sujata Enterprises Inc,dba Citgo Food Ma

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0650 Civil Money Penalty;William Craft and Robert Thigpen,dba Nic

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0651 Civil Money Penalty;Town and Country Supermarket of Hardy In

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0652 Civil Money Penalty;Bobby Wolfe and May Wolfe,dba BMW Pit St

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0669 Civil Money Penalty;Speedway Superamerica LLC,dba Super Amer

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00M-0809 P990034; Cellugel Ophthalmic Viscosurgical Device

AAV 1 Alcon Labs. Vol#: 1

00M-0810 P900009/S6; Exogen 2000/Sonic Accelerated Fracture Healing

AAV 1 Exogen, Inc. Vol#: 1

00N-0597 Codex Alimentarious Meetings

NCR 1 Vol#: 1

00N-0836 Environmental Impact Considerations

N 1 Vol#: 1

00P-1077 Amend Current Reg Banning Sale of Small Turtles

ACK 1 HFA-305 Vol#: 1

CP 1 The Humane Society of the United States Vol#: 1

00P-1084 Diabetes Drugs Troglitazone,rosiglitazone,pioglitazone

CP 1 Public Citizen's Health Group Vol#: 1

00P-1085 Classify cranial helment in class I,exempt from premarket

CP 1 American Orthotic & Prosthetic Ass Vol#: 1

00V-1076 Laser Light Show Mobolazer ML10-200,ML10-300,ML10-300W,ML100

ACK 1 HFA-305 Vol#: 1

VAR 1 GDM Event Services Vol#: 1