DOCKETS ENTERED on 08/11/99

Docket Title

Number

77N-0240 Single-Entity Coronary Vasodilators

C 9 The University of Michigan Hlth System Vol#: 32

SUP 28 Eon Labs Manufacturing, Inc. Vol#: 53

SUP 29 McKenna & Cuneo, L.L.P. Vol#: 32

SUP 30 McKenna & Cuneo, L.L.P. Vol#: 32

96F-0493 Safe Use of a Mixture of Hydrogen Peroxide & Sodium Bicarbon

NDL 2 Gernard T. O'Brien Vol#: 1

96P-0215 Withdrawal Norplant's approval for sale in the United States

C 204 Valerie Baker Vol#: 5

C 205 Theresa Pelster Vol#: 5

C 206 J. Baker Vol#: 5

C 207 Teresa Sobie Vol#: 5

98H-0625 Civil Money Penalties;Haider Abed Albarakat d/b/a Babylon Ma

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0763 Civil Money Penalties;Gul Faraz,d/b/a Houston Corner Store

NFR 1 Departmental Appeals Board Vol#: 1

98H-1178 Civil Money Penalties; Framingham Gulf Inc

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1182 Civil Money Penalties; Kmart Corporation

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1186 Civil Money Penalties;Phar-Mor Inc

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1187 Civil Money Penalties;Rich's Standard Inc,d/b/a Rich's Amoco

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98N-0040 Regs for In Vivo Radiopharm used for Diagnosis & Monitoring

NAL 1 HFA-250 Vol#: 1

SS 1 Supporting Statement Vol#: 1

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

C 22387 American Academy of Pediatrics Vol#: 876

C 22388 Nuhealth Corporation Vol#: 876

C 22389 Electronic Retailing Assn Vol#: 876

C 22390 Seton Hall University Vol#: 876

LST 1 Agenda Attendees to 8/4/99 meeting Vol#: 876

REF 2 Nutrition Labeling Watch Vol#: 876

REF 3 Recall/Regulatory Analysis Vol#: 876

REF 4 Dietary Supplement Regulatory Report Vol#: 876

TS 3 Consumer Healthcare Products Assn Vol#: 876

TS 4 Ullman Shapiro & Ullman LLP Vol#: 876

TS 5 Ullman Shapiro & Ullman LLP Vol#: 876

TS 6 Council for Responsible Nutrition (CRN) Vol#: 876

TS 7 Jarrow Formulas Inc Vol#: 876

TS 8 Nutritional Sciences Vol#: 876

TS 9 PhRMA Vol#: 876

TS 10 College of American Pathologists Vol#: 876

TS 11 CSPI Vol#: 876

TS 12 American Herbal Products Assn Vol#: 876

TS 13 Shape Up America Vol#: 876

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

EC 1 Lynn Markham Vol#: 114

98N-1265 Distribution of Compounded Drug Products

C 5488 Holleb & Coff (Attorneys at Law) Vol#: 165

C 5489 Holleb & Coff (Attorneys at Law) Vol#: 165

C 5490 Signe Sellwood Vol#: 165

C 5491 State of New Hampshire Board of Pharmacy Vol#: 165

C 5492 Schachter Center for Complementary Med Vol#: 165

C 5493 Louisiana Board of Pharmacy Vol#: 165

C 5494 California State Board of Pharmacy Vol#: 165

C 5495 Dorothy A. Young Vol#: 165

C 5496 Linda Miller Vol#: 165

C 5497 Susan E. Griffith Vol#: 165

C 5498 Mikell E. Cribbs Vol#: 165

C 5499 Gillian Sinclair Vol#: 165

C 5500 Susan Martell Vol#: 165

C 5501 Nanette M. Manhart Vol#: 165

C 5502 Georgia Goldfarb, M.D. Vol#: 165

C 5503 Camilla T. Bishop Vol#: 165

C 5504 Kip Morrison & Associates Vol#: 165

C 5505 Delores D. Doyle Vol#: 165

C 5506 Judy R. Reis Vol#: 165

C 5507 Ruthann G. Bill Vol#: 165

C 5508 Patricia Werner Vol#: 165

C 5509 Mercedes Zinymark Vol#: 165

C 5510 Robert L. Beziat Vol#: 165

C 5511 Holland Center for Family Health Vol#: 165

C 5512 Barbara Miranda Vol#: 165

C 5513 Doreen A. Taylor Vol#: 165

C 5514 Susan K. Piercy Vol#: 165

C 5515 Pearl Van Vaketis Vol#: 165

C 5516 Catherine Bugey Vol#: 165

C 5517 Katherine B. Klamp Vol#: 165

C 5518 Martha Ringer Vol#: 165

C 5519 Anita H. Sanchez Vol#: 165

C 5520 Jean A. Morris Vol#: 165

C 5521 Dorothy K. Cinquemani Vol#: 165

C 5522 Sandra F. Montgomery Vol#: 165

C 5523 CollaGenex Pharmaceuticals Vol#: 165

C 5524 State of Washington Dept of Health Vol#: 165

C 5525 Mr & Mrs Gerald Holmgren Vol#: 165

C 5526 Rebecca R. Rletcher Vol#: 165

C 5527 Jade Welling Vol#: 165

C 5528 Sandra Gunn Vol#: 165

C 5529 Ethel P. Thompson Vol#: 165

C 5530 Barbara Keatz Vol#: 165

C 5531 June Russell Vol#: 165

C 5532 Lorraine Bahrick Vol#: 165

C 5533 Janice M. Hollowell Vol#: 165

C 5534 Illegible Vol#: 165

C 5535 Mary Kison Vol#: 165

C 5536 Judy Burke Vol#: 165

C 5537 Cheryl V. Davis Vol#: 165

C 5538 Barbara Byrd Vol#: 165

C 5539 Michelle S. Patente Vol#: 165

C 5540 Cheryl Soule Vol#: 165

C 5541 Donald Hoffman Vol#: 165

C 5542 Addie & Bill Bishin Vol#: 165

C 5543 Ruth Karen Loughin Vol#: 165

C 5544 Jane L. Hix Vol#: 165

C 5545 Linda J. Mechley Vol#: 165

C 5546 Genevieve E. Heffner Vol#: 165

C 5547 Beatrice McGrath Vol#: 165

C 5548 Shirley J. Wilcox Vol#: 165

C 5549 Miriam K. Suggs Vol#: 165

C 5550 Lesa Davis Vol#: 165

C 5551 Camilla T. Bishop Vol#: 165

C 5552 Mary Marler Vol#: 165

C 5553 Sue C. Neher Vol#: 165

C 5554 Helena D. Davis Vol#: 165

C 5555 Lois Chilis Vol#: 165

C 5556 Lisa & Larry Miner Vol#: 165

C 5557 Karen L. Careen Vol#: 165

C 5558 Georgia Goldfarb Vol#: 165

C 5559 Theodora Weidemann Vol#: 165

C 5560 Hassie Taylor Vol#: 165

C 5561 Susan B. Collins Vol#: 165

C 5562 Nancy Moloney Vol#: 165

C 5563 Patricia F. Moore Vol#: 165

C 5564 Judy McNeilly Vol#: 165

C 5565 Constance N. Callahan Vol#: 165

C 5566 Julie LaFond Vol#: 165

C 5567 Patricia A. Zibits Vol#: 165

C 5568 Judith Horky Vol#: 165

C 5569 Vivian Ratliff Vol#: 165

C 5570 Melinda Michael Vol#: 165

C 5571 Elizabeth Haggerty Vol#: 165

C 5572 Candace Head Vol#: 165

C 5573 Cherri L. Gilbert Vol#: 165

C 5574 Sidney A. Krimsky Vol#: 165

C 5575 Marcy A. McEwen Vol#: 165

C 5576 Barbara Shellmar Vol#: 165

C 5577 Lynn A. Wahlstrom Vol#: 165

C 5578 James E. Huber Vol#: 165

C 5579 Sheila Cossett Vol#: 165

C 5580 R. V. Barrows Vol#: 165

C 5581 Shasta Hartzell Vol#: 165

C 5582 Susan H. Neathamer Vol#: 165

C 5583 Andrea Rimberg Vol#: 165

C 5584 Caroline Sontheimer Vol#: 165

C 5585 Von Perry Vol#: 165

C 5586 Janet E. Carr Vol#: 165

C 5587 Karen Hudson Vol#: 165

C 5588 Cecelia Gibbons Vol#: 165

LET 2 Congress of the United States Vol#: 165

LET 3 Congress of the United States Vol#: 165

99D-2013 Cooperative Manufacturing Arrangements for Licensed

GDL 1 Guidance Vol#: 1

NAD 1 Vol#: 1

99D-2152 Device Use Safety: Incorporating Human Factors in Risk

GDL 1 Guidance Vol#: 1

NAD 1 Vol#: 1

99D-2212 Quality Systems Regulation Information for Various Premarket

GDL 1 Guidance Vol#: 1

NAD 1 Vol#: 1

99H-0395 Civil Money Penalty; Cel-Cris Corp. d/b/a/ Packer Sales

LET 2 Office of Tobacco Programs Vol#: 1

99H-0409 Civil Money Penalties;Ramey & Sons Inc,d/b/a Ramey's Superva

ANS 1 Ramey & Sons, Inc. Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

99H-0521 Civil Money Penalties;Midstream Fuel Service Inc,d/b/a Chevr

LET 2 Office of Tobacco Programs Vol#: 1

99H-0585 Civil Money Penalties;Jim Boeving,d/b/a Sto's Stop

ANS 1 Sto's Stop Vol#: 1

LET 2 HHS/CDER/FDA Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1052 Civil Money Penalties;Sandy's Variety Store II,& Santo Baez

LET 2 Office of Tobacco Programs Vol#: 1

99H-1607 Civil Money Penalty;Rite Aid of Kentucky Inc dba Rite Aid Ph

LET 2 Office of Tobacco Programs Vol#: 1

99H-1661 Civil Money Penalty;Leslie Burgett,dba Les' Mini Mart

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 HHS/CDER/FDA Vol#: 1

99H-1677 Civil Money Penalty;Waverly Square Service Inc,dba Waverley

LET 2 Office of Tobacco Programs Vol#: 1

99H-1830 Civil Money Penalty;Bullards Market & Package Store Inc,dba

LET 2 Office of Tobacco Programs Vol#: 1

99H-1974 Civil Money Penalty;Rocky Mountain Pharmacy of Estes Park

ANS 2 Rocky Mountain Pharmacy of Estes Park Vol#: 1

99H-2008 Civil Money Penalty;Jim Morgan,dba Jiffy Jim's 1-Stop

ANS 1 Jiffy Jim's 1 Stop Vol#: 1

99H-2056 Civil Money Penalty;J & J Foods Inc,dba Joel's Jack & Jill

ANS 1 J&J Foods, inc. Vol#: 1

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

LET 2 Office of Tobacco Programs Vol#: 1

99H-2108 Civil Money Penalty;Doris Brown,dba The Food Bank

ANS 1 The Food Bank Vol#: 1

99H-2136 Civil Money Penalty;Kroger Ltd Partnership I,dba Kroger Food

ANS 1 Kroger Limited Partnership 1 Vol#: 1

99H-2191 Civil Money Penalty;Harold Myer & Linda H Myer,dba Rock Bluf

ANS 1 Rock Bluff General Store Vol#: 1

99H-2310 Civil Money Penalty;Midwest Energy Inc,dba Amerimart

ANS 1 Midwest Energy Incorporated Vol#: 1

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

ANS 1 Country Cupboard Vol#: 1

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

LET 2 Office of Tobacco Programs Vol#: 1

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

ANS 1 Wink's Convenience Stores Vol#: 1

99H-2493 Civil Money Penalty;Host Enterprises Inc,dba Winks

ANS 1 Wink's Convenience Stores Vol#: 1

99H-2506 Civil Money Penalty;James Wood & Joan Wood,dba Fox Quick Sto

ANS 1 Fox Quik Store Vol#: 1

99H-2539 Civil Money Penalty;Dina G. Corporation,dba Food Land

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2540 Civil Money Penalty;Freeport Cooperative Creamery Associatio

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2541 Civil Money Penalty;Honey Farms Inc,dba Honey Farms

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

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

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2543 Civil Money Penalty;McLean County Fuel Corporation Inc,dba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2544 Civil Money Penalty;Rodgers Package Store Inc,dba John's Pac

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2545 Civil Money Penalty;Sportsman's Royal Manor LLC,dba Sportsma

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

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

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99M-2671 P980035 - Medtronic.Kappa 700/600 Pacemakers

AAV 1 Medtronic, Inc. Vol#: 1

99M-2672 P950015 - The Heart Laser CO2 TMR System

AAV 1 PLC Medical Systems, Inc. Vol#: 1

99N-2250 Blood and Blood Components at Increased Risk for Transmittin

N 1 Vol#:

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

ANS 1 HF-40 to Angad Khalsa Vol#: 22

ANS 2 HF-40 to Vicki Deisner Vol#: 22

C 1371 Edith Morales Vol#: 22

C 1372 J Capozzelli Vol#: 22

C 1373 Kellie Teter Vol#: 22

C 1374 Gale Zimmerman Vol#: 22

C 1375 Angad Khalsa Vol#: 22

C 1376 Vicki Deisner Vol#: 22

EC 1 Ann Mazza Vol#: 22

EC 2 Jerry Jennings Vol#: 22

EC 3 Mary Pray Vol#: 22

EC 4 Charlene May Vol#: 22

EC 5 Steven Hill Vol#: 22

EC 6 Audrey W Katz Vol#: 22

EC 7 Dennis Adsit PhD Vol#: 22

EC 8 Susan Lausell Vol#: 22

EC 9 Ron & Charlotte Gumtow Vol#: 22

EC 10 Gerald Steinle Vol#: 22

EC 11 Matthew Pertz Vol#: 22

EC 12 Lynn Markham Vol#: 22

EC 13 Mike Ernst Vol#: 22

EC 14 Mrs Lana Huston Vol#: 22

EC 15 Hugh Moore Vol#: 22

99P-1652 Standards & Procedures for Patient Registries for Clozapine

C 1 Novartis Pharmaceutical Corp. Vol#: 1