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 January 19, 2000

Table of Contents

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

[FDA DOCKETS PAGE][FDA HOME PAGE]  [ ITEM CODES ]
 
97N-484S Human Cellular and Tissue-Based Products *
99D-3082 E10- Choice of Control Group in Clinical Trials *
91N-0098 Dietary Fiber & Cancer, Health Claims & Label Statements

NEC 1 Notice of extension for comments Vol#: 20

91N-0101 Antioxidant Vitamins & Cancer,Hlth. Claims & Label Statement

NEC 2 Notice of extension for comments Vol#: 40

91N-0103 Fatty Acids & Heart Disease, Hlth.Claims & Label Statements

NEC 1 Notice of extension for comments Vol#: 29

91N-100H Health Claims & Label Statements; Folate & Neural Tube Defec

NEC 1 Notice of extension for comments Vol#: 11

94N-0449 New Drug Applications; Drug Master Files

NFR 1 Vol#: 1
 
 

97N-484S Human Cellular and Tissue-Based Products

C 391 Montgomery Orthopaedics, P.A. Vol#: 22

C 392 Wayne State University Hutzel Hospital Vol#: 22

C 393 Reproductive Gynecology Vol#: 22

C 394 Boston IVF the Brookline Ctr. Vol#: 22

C 395 Fertility Institute of Fort Lauderale Vol#: 22

C 396 The GBMC Fertility Center Vol#: 22

C 397 IVF New Jersey Vol#: 22

C 398 NCLR, National Ctr. for Lesbian Rights Vol#: 22

C 399 Allegheny General Hospital IVF Program Vol#: 22

C 400 Leland Traiman, RN/FNP Vol#: 22

C 401 Allegheny General Hospital IVF Program Vol#: 22

C 402 Ctr for Advanced Reproductive Medicine & Vol#: 22

C 403 Infertility & IVF Ctr Advanced Reproduct Vol#: 22

C 404 Ferdic, Inc. Vol#: 22

C 405 Boston IVF the Brookline Center Vol#: 22

C 406 William O. Smith, M.D. Vol#: 22

C 407 Lisa J. Shetler Vol#: 22

C 408 Mayo Clinic Vol#: 22

C 409 Alan Rashkin, M.D. Vol#: 22

C 410 Neurosurgical Care, Inc. Vol#: 23

C 411 University of Connecticut Health Center Vol#: 23

C 412 Boston Arthritis & Spinal Surgery Vol#: 23

C 413 Eye Surgery Associates Vol#: 23

C 414 Central Ohio Eye Bank, Inc. Vol#: 23

C 415 Spine Surgery Associates Vol#: 23

C 416 NA, Neurosurgical Associates of NJ, PC Vol#: 23

C 417 Long Island Spine Specialists, P.C. Vol#: 23

C 418 Garth P. Vol#: 23

C 419 Reproductive Science Center of Boston Vol#: 23

C 420 Central Ohio Neurological Surgeons Vol#: 23

C 421 Reproductive Partners Medical Group, Inc Vol#: 23

C 422 Hartford Fertility & Reproductive Endocr Vol#: 23

C 423 LifeSouth Community Blood Centers Vol#: 23

C 424 San Antonio Orthopaedic Group Vol#: 23

C 425 Indianapolis Nuerosurgical Group Vol#: 23

C 426 University of Kentucky Chandler Med. Ctr Vol#: 23

C 427 Spinal & Orthopaedic Surgery Vol#: 23

C 428 Southeastern Fertility Center, P.A. Vol#: 23

C 429 University of Connecticut Hlth Center Vol#: 23

C 430 The Intl. Assn. of Lions Clubs Vol#: 23

C 431 John L. Couvaras, M.D. Vol#: 23

C 432 The Eye Institute, Inc. Vol#: 23

C 433 University OB/GYN Associates, PLLC Vol#: 23

C 434 Delaware Valley Institute of Fertility & Vol#: 23

C 435 The Neuromusculoskeletal Ctr of the Casc Vol#: 23

C 436 Christopher O. Neubuerger, M.D. Vol#: 23

C 437 Duke Neurosurgical Associates of Lumbert Vol#: 23

C 438 Specialists In Reproductive Medicine & S Vol#: 23

C 439 Lehigh Valley Eye Center, P.C. Vol#: 23

C 440 Fertility Treatment Ctr., P.C. Vol#: 23

98H-0954 Civil Money Penalties;Albertson's In.,dba Albertson's #879

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0961 Civil Money Penalties;The Store 24 Inc.,d/b/a Store 24

LET 2 Office of Tobacco Programs Vol#: 1

98H-0962 Civil Money Penalties;Texaco Refining & Marketing Inc.

LET 2 Office of Tobacco Programs Vol#: 1

98H-0977 civil Money Penalty; The Pantry Inc.

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0986 Civil Money Penalties; Wal-Mart Stores Inc.

lET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0988 Civil Money Penalties;Ray Ball,d/b/a Ball's Country Market

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1007 Civil Money Penalties; Graham C-Store Co.

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1009 Civil Money Penalties; Lee Cavanaugh,d/b/a Euclid & Route 53

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1026 Civil Money Penalties;Jitney Jungle Stores of America. #19

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1044 Civil Money Penalties; Leroy Guice, d/b/a Guice 28 Go-Mart

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1046 Civil Money Penalties;Independent Oil & Coal Co,d/b/a Philli

LET 3 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1047 Civil Money Penalties;Delores Leblanc,d/b/a Trail Lake Store

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1048 Civil Money Penalties;Jim McGill,d/b/a Sunrise Quick Stop

LET 2 Office of Tobacco Programs Vol#: 1

98H-1050 Civil Money Penalties; Ramco Inc,d/b/a Minit Mart 33

LET 3 Office of Tobacco Programs Vol#: 1

98H-1053 Civil Money Penalties;Gary Mathias, d/b/a Baltimore Shell

LET 2 Office of Tobacco Programs Vol#: 1

98H-1070 Civil Money Penalties;Rehmet Inc, d/b/a Northwest Shell

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1073 Civil Money Penalties;Wal-Mart Stores Inc,d/b/a Wal-Mart 708

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1076 Civil Money Penalties; Burns Oil Co Inc,d/b/a Conoco #23

LET 2 Office of Tobacco Programs Vol#: 1

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

C 22403 Martha Parry Vol#: 876
 
 

99D-3082 E10- Choice of Control Group in Clinical Trials

C 2 AstraZeneca LP Vol#: 1

C 3 University of Wisconsin- Madison Vol#: 1

C 4 Bristl-Myers Squibb Vol#: 1

99H-5136 Civil Money Penalty;Grand Casinos of Mississippi,LLC-Gulfpor

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5469 Civil Money Penalty;Eckerd Corporation;dba Eckerd Drug #6674

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

C 412 Shannon Leon' Vol#: 42

C 413 Corinne Sen Vol#: 42

C 414 Dr Sidnee Curtis Vol#: 42

C 415 Tweed A Conrad Vol#: 42

C 416 Laurence Malsky Vol#: 42

C 417 Renata Sytserma Vol#: 42

C 418 Steve Hopkins Vol#: 42

C 419 Susan Hubbard Vol#: 42

C 420 Page Prescott Vol#: 42

C 421 Joseph W Judge Vol#: 42

C 422 M J Zoeckler Vol#: 42

C 423 Patricia A Gribble PhD Vol#: 42

C 424 Ann C Tate Vol#: 42

C 425 Monica F Dougherty Vol#: 42

C 426 Mary Catherine Ryan Vol#: 42

C 427 Irene Mann Vol#: 42

C 428 Jessica Holloway Vol#: 42

C 429 Donald A Smith Vol#: 42

C 430 Daniel Jon Dorneden Vol#: 42

C 431 Michael Szymanski Vol#: 42

C 432 Paul Letky LLoyd Vol#: 42

C 433 Alisa Clyne Vol#: 42

C 434 Leon Wyatt Vol#: 42

C 435 Joan T Burnes Vol#: 42

C 436 Rachel Massey Vol#: 42

C 437 Brenda McMillan Vol#: 42

C 438 Martin & Rhoda Lonow Vol#: 42

C 439 Mary Pat Reeve Vol#: 42

C 440 Hjord's Olson Vol#: 42

C 441 Janet Mrowka Vol#: 42

C 442 Richard Baldwin Vol#: 42

C 443 Elizabeth Owens Vol#: 42

C 444 Judith Price Vol#: 42

C 445 Greg & Anya Lecuyer Vol#: 42

C 446 Joanne Holbrook Vol#: 42

C 447 A E Bennett Vol#: 42

C 448 Beryl Engle Vol#: 42

C 449 Sherry Patrick Vol#: 42

C 450 Frank Wihbey Vol#: 42

C 451 Martin Gold Vol#: 42

C 452 Karen Bumann Vol#: 42

C 453 Hilary Ernst Vol#: 42

C 454 Richard Hammer Vol#: 42

C 455 Thelma Garvin Vol#: 42

C 456 Gloria Howard Vol#: 42

C 457 Daniel Sheehan Vol#: 42

C 458 Deitra Wesley Vol#: 53

C 459 Meghen Atkinson Vol#: 53

C 460 Parker J Forsell Vol#: 53

C 461 Carrie Stewart Vol#: 53

C 462 Troy C Jones Vol#: 53

C 463 Linda Jenks Vol#: 53

C 464 Kathryn A Miller Vol#: 53

C 465 Betsy Taylor Vol#: 53

C 466 Richard A McKinney Vol#: 53

C 467 Richard A McKinney Vol#: 53

C 468 Karen S Engel Vol#: 53

C 469 Nancy Schimmel Vol#: 53

C 470 Margaret Knight Vol#: 53

C 471 Donna Hilmers Vol#: 53

C 472 Julia R Innella Vol#: 53

C 473 Zlatko Batistich Vol#: 53

C 474 John Beattie & Brennan Michaels Vol#: 53

C 475 Ruth Dasche Vol#: 53

C 476 Jon Bergstrom Vol#: 53

C 477 Alan D Henning Vol#: 53

C 478 Robert Bucher Vol#: 53

C 479 Helen Farnam Vol#: 53

C 480 Regina M Wieman PhD Vol#: 53

C 481 Shannon Baglehe Vol#: 53

C 482 Katherine Sue Powell Vol#: 53

C 483 Cheryl Sutherland Vol#: 53

C 484 Mr & Mrs Irwin Luckman Vol#: 53

C 485 E Cowen Phillips Vol#: 53

C 486 Jacqueline Meyer-Irons Vol#: 53

C 487 Roslyn Young Vol#: 53

C 488 Diana T Spencer Vol#: 53

C 489 Christine Hoeflich Vol#: 53

C 490 Jon G Panozzo Vol#: 53

C 491 Margaret Roberts Vol#: 53

C 492 Julie A Singleton Vol#: 53

C 493 Tom Bacchus Vol#: 53

C 494 Larry Lack & Lee Ann Ward Vol#: 53

C 495 Julie Baird Vol#: 53

C 496 Kate Greene Vol#: 53

C 497 Philip E & Joanne B Kehr Vol#: 53

C 498 Sidney & Irma Goodman Vol#: 53

C 499 Eileen Zack Vol#: 53

C 500 Mildred Lanford Vol#: 53

C 501 Alice B Bartholomew Vol#: 53

C 502 Jan Lindsey Vol#: 53

C 503 Bonnie J Snow Vol#: 53

C 504 Carol Beth Vol#: 53

C 505 Susan F Manata Vol#: 53

C 506 Susan Foley Vol#: 53

C 507 Peter Arneson Vol#: 53

C 508 Anne M Monahan Vol#: 53

C 509 Robert Faller Vol#: 53

C 510 Marilyn Cunningham Vol#: 53

C 511 Patrick A Moore Vol#: 53

C 512 Jane Faller Vol#: 53

C 513 Tanya Kern Vol#: 53

C 514 Susan E Richards Vol#: 53

EMC 827 Mike Wilkinson Vol#: 42

EMC 828 Lynn Davis Vol#: 42

EMC 829 Raymond D Muccianti Vol#: 42

EMC 830 Richard Stoney Vol#: 42

EMC 831 Amy Leo Barankovich Vol#: 42

EMC 832 Terry L Hellums Vol#: 42

00H-0054 Civil Money Penalty;Albertson's,Inc;dba Albertson's Food &

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0055 Civil Money Penalty;Kathy Camp;dba Camp's Village Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0056 Civil Money Penalty;Kyong O.Seo Cho;dba Manna One Deli

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0057 Civil Money Penalty;Clark Retail Enterprises,Inc;dba Clark

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0058 Civil Money Penalty;Cross Buy-Ways,Inc;dba Bartonville Disco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0059 Civil Money Penalty;CVS Pharmacy,Inc;CVS Pharmacy #2045

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0060 Civil Money Penalty;CVS Pharmacy,Inc;dba CVS Pharmacy #4410

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0061 Civil Money Penalty;Eckerd Corporation;dba Eckerd Drug #8390

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0062 Civil Money Penalty;James Ellis & Rebecca Ellis;dba Smoky

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0063 Civil Money Penalty;Ralph Ensey & Lavern Ensey;dba Ensey's

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0064 Civil Money Penalty;G & W Grocery,Inc;dba G & W Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0066 Civil Money Penalty;Hammer-Williams Company;dba Curve Jiffy

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0067 Civil Money Penalty;Kyoo Suk Han;dba Maccall's Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0068 Civil Money Penalty;Richard Howe & Patricia Howe;dba Howe's

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0069 Civil Money Penalty;J Y Hwang,Inc;dba Big Town Carry Out

LET 1 Office of Tobacco Programs Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0070 Civil Money Penalty;Jackson Food Stores,Inc;dba Jackson Food

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0071 Civil Money Penalty;Kroger Co;dba Kroger Food Store #792

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0072 Civil Money Penalty;Barrie Lau;dba 7-Eleven #11725

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0073 Civil Money Penalty;Love's Country Stores,Inc;dba Love's

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0074 Civil Money Penalty;Glenna McCurdy and Wanda Christian;dba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0075 Civil Money Penalty;Melcam,Inc;dba Mel's Amoco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0076 Civil Money Penalty;Manolo Munoz and Francis Munoz;dba Best

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0077 Civil Money Penalty;Planters Cooperative Association;dba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0078 Civil Money Penalty;Coleen Powell;dba Powell One Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0079 Civil Money Penalty;Mohmed Rustom;dba Convenient Food Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0081 Civil Money Penalty;Twin Cities Stores,Inc;dba Oasis Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0082 Civil Money Penalty;Westview Service Center,Inc;dba Westview

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0083 Civil Money Penalty;Wright's Liquor Store,Inc;dba Sam Wright

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0178 Civil Money Penalty;C.Wheeless Enterprises,Inc;dba Harford

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0179 Civil Money Penalty;CVS Pharmacy,Inc;dba CVS Pharmacy #4638

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0180 Civil Money Penalty;Zahid Feroz;dba Harford Amoco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0181 Civil Money Penalty;Freestate Petroleum Corporation;dba Free

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0182 Civil Money Penalty;How-Soel,Inc;dba Logan's Market #244

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0183 Civil Money Penalty;Chin Y. Hwang & Young S. Hwang;dba Clift

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0184 Civil Money Penalty;Farrakh A. Khan;dba Getty Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0185 Civil Money Penalty;Juan Rivera;dba Ideal Grocery & Deli

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

Page updated September 17, 2003 jb