DOCKETS ENTERED on May 13, 1999
TABLE OF CONTENTS
(ONLY FOR HYBERLINKED
ITEMS)
78N-0038
Sunscreen Drug Products
97S-0162
30-Day Structure Function Claim Notification Letters Dietary
97S-0163
Dietary Supplements, Courtesy Letters (Letters of Objection)
98D-1146
Microbial effects of antimicrobial new animal drugs/human sa
98E-0485
Therma Choice Uterine Balloon Therapy System U.S.#5,105,808
98E-0850
Patent Extension 4,949,718 ThermaChoice Uterine Balloon Ther
98N-1038
Irradiation in the production, processing, &handling of food
98N-1265
Distribution of Compounded Drug Products
98P-0151
Introduction Of Downed Cattle Into The Food Supply
98P-0504
Raw Molluscan Shellfish of Undetectable Levels
98P-0968
Guidance regarding Surimi Ingredient Labeling
98P-1194
Withdrawal NADA Approval for Posilac - rBGH
99N-0438
Contamination ready-to-eat foods associated food prepartion
99P-0485
Rescind Approval of Subtherapeutic Antibiotic Use Livestock
99P-0795
Amend regulations on bottled water
77N-0085 Saccharin and Its Salts
CA 27599 B W Morris Vol#: 431
CA 27600 C W Mansfield Sr. Vol#: 431
CA 27602 R Altschuler et al Vol#: 431
CA 27603 A Bambrick Vol#: 431
CA 27604 C Wooldridge Vol#: 431
CA 27605 G Aguilar Vol#: 431
CA 27606 C N Black Vol#: 431
CA 27607 C Leonard Vol#: 431
CA 27608 K Collins Vol#: 431
CA 27609 D Kaczor Vol#: 431
CA 27610 W & E Culberton Vol#: 431
CA 27611 J T Rudd Vol#: 431
CA 27612 O Porteous et al Vol#: 431
CA 27613 C Buchan Vol#: 431
CA 27614 D Beaver Vol#: 431
CA 27615 H A Holzkamper Vol#: 431
CA 27616 C A Kissel Vol#: 431
CA 27617 R F Ratteree Vol#: 431
CA 27618 L M Smith & D Ohetto Vol#: 431
CA 27619 M Ziegler Vol#: 431
CA 27620 L G Bergman Vol#: 431
CA 27621 Indianapolis Pepsi-Cola Bottling Co Vol#: 431
CA 27622 J B Veach Vol#: 431
CA 27623 B Brooks et al Vol#: 431
CA 27624 J F Blazin Vol#: 431
CA 27625 E P Frolik Vol#: 431
CA 27626 E C Miller Vol#: 431
CA 27627 R Cavanagh Vol#: 431
CA 27628 A C Schaumburg Vol#: 431
CA 27629 S N Diamond, D.D.S. Vol#: 431
CA 27630 E Freeman Vol#: 431
CA 27631 E Otto Vol#: 431
CA 27632 D K Biery Vol#: 431
CA 27633 J Lanser Vol#: 431
CA 27634 Unsigned Vol#: 431
CA 27635 I Cohn Vol#: 431
CA 27636 M H Jacobson Vol#: 431
CA 27637 H Allen Vol#: 431
CA 27639 D Nieves Vol#: 431
CA 27640 W Kronenberg Vol#: 431
CA 27641 H G Noyes Vol#: 431
CA 27642 R D Watson Vol#: 431
CA 27643 G Nagy Vol#: 431
CA 27644 A Bocast Vol#: 431
CA 27645 A E Doak Vol#: 431
CA 27646 M E & R G Roe Vol#: 431
CA 27647 F N Freeman Vol#: 431
CA 27648 J B Hunnicut Vol#: 431
CA 27649 T Lazar et al Vol#: 431
CA 27650 D Loper Vol#: 431
CA 27651 J Urbanic Vol#: 431
CA 27652 S C Barbee Vol#: 431
CA 27653 J G Haney Vol#: 431
CA 27654 D L O'Connor Vol#: 431
CA 27655 C J Harrold Vol#: 431
CA 27656 E D Smith Vol#: 431
CA 27657 M B Hoffman Vol#: 431
CA 27658 J E Walsh, Jr. Vol#: 431
CA 27660 R C Nichols, Jr. Vol#: 431
CA 27661 J A Butterworth Vol#: 431
CA 27662 H W Martin Vol#: 431
CA 27663 J B Dilworth. Jr. Vol#: 431
CA 27664 J Jones Vol#: 431
CA 27665 K H Bower, Jr. Vol#: 431
CA 27666 D C Woldert Vol#: 431
CA 27667 D Morton Vol#: 431
CA 27668 R W Darter, M.D. Vol#: 431
CA 27669 J H Smith, Jr. Vol#: 431
CA 27670 J Harvey Vol#: 431
CA 27671 S Clapper Vol#: 431
CA 27672 N J Fairchild Vol#: 431
CA 27673 Amarillo Coca-Cola Bottling Co., Inc. Vol#: 431
CA 27674 C J Nonenmacher Vol#: 431
CA 27675 H Malone Vol#: 431
CA 27676 J R Schumacher Vol#: 431
CA 27677 T R, E I & J E Joha Vol#: 431
CA 27678 J Deiso Vol#: 431
CA 27679 A L Richmond Vol#: 431
CA 27680 D Saddler Vol#: 431
CA 27681 Fr. H J Brown Vol#: 431
CA 27682 L Eaker Vol#: 431
CA 27683 J W Heptinstall Vol#: 431
CA 27687 T Harris Vol#: 431
CA 27688 R I Powell Vol#: 431
CA 27689 M Hurtado Vol#: 431
CA 27690 E R Gibson Vol#: 431
CA 27691 F Hartigan Vol#: 431
CA 27692 T Williams Vol#: 431
CA 27693 B P Oakley Vol#: 431
CA 27694 J Grider Vol#: 431
CA 27695 K Fleischman Vol#: 431
CA 27696 H G Parsons Vol#: 431
CA 27697 B J Clementsen Vol#: 431
CA 27698 G S Ehlers Vol#: 431
CA 27699 C Consentino Vol#: 432
CA 27700 H C Wurth Vol#: 432
CA 27701 D Wolff Vol#: 432
CA 27702 J Matterah Vol#: 432
CA 27703 E Flax Vol#: 432
CA 27704 T M Costello Vol#: 432
CA 27705 Y Ensslin Vol#: 432
CA 27706 C Tucker Vol#: 432
CA 27707 T Smith Vol#: 432
CA 27708 D Ransdell Vol#: 432
CA 27709 L McKinney Vol#: 432
CA 27710 M Hume Vol#: 432
CA 27711 S Gunzelmann Vol#:
CA 27712 C Riele Vol#: 432
CA 27713 J S Johnson Vol#: 432
CA 27714 J A Iselin Vol#: 432
CA 27715 G Meadows Vol#: 432
CA 27716 R H Buckerfield Vol#: 432
CA 27717 J L Baier Jr. Vol#: 432
CA 27718 P Ankrum Vol#: 432
78N-0038 Sunscreen Drug Products
C 555 The Procter & Gamble Company Vol#: 128
97S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 3515 Hetty Enterprise USA Inc Vol#: 22
LET 3516 Mason Vitamins Inc Vol#: 22
LET 3517 Mason Vitamins Inc Vol#: 22
LET 3518 Mason Vitamins Inc Vol#: 22
LET 3519 Mason Vitamins Inc Vol#: 22
LET 3520 Mason Vitamins Inc Vol#: 22
LET 3521 Mason Vitamins Inc Vol#: 22
LET 3522 Mason Vitamins Inc Vol#: 22
LET 3523 Mason Vitamins Inc Vol#: 22
LET 3524 Mason Vitamins Inc Vol#: 22
LET 3525 Mason Vitamins Inc Vol#: 22
LET 3538 Bee-Alive Inc Vol#: 22
LET 3544 Source Naturals Vol#: 22
LET 3545 Source Naturals Vol#: 22
LET 3546 Source Naturals Vol#: 22
LET 3547 Source Naturals Vol#: 22
LET 3548 Tall Oak Farm Vol#: 22
LET 3549 Leiner Health Products Vol#: 22
LET 3550 Leiner Health Products Vol#: 22
LET 3551 Leiner Health Products Vol#: 22
LET 3552 Leiner Health Products Vol#: 22
97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)
LET 269 HFS-456 to Hetty Enterprise USA Inc Vol#: 6
LET 270 HFS-456 to Square Roots Inc Vol#: 6
LET 271 HFS-456 to Chinese Herb Center Inc Vol#: 6
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa
98E-0319 GenESA (arbutamine hydrochloride); U.S. Patent #5,234,404
N 1 Vol#: 1
98E-0485 Therma Choice Uterine Balloon Therapy System U.S.#5,105,808
98E-0842 Patent Extension AGGRASTAT (tirofiban HCL) 5,292,756
N 1 Vol#: 1
98E-0850 Patent Extension 4,949,718 ThermaChoice Uterine Balloon Ther
98H-0685 Civil Money Penalties;Crown Central Petroleum,d/b/a Crown
RMO 1 GCF-1 Vol#: 1
98H-0688 Civil Money Penalties;Fast Fare Inc,d/b/a Fast Fare Store
RMO 1 GCF-1 Vol#: 1
98H-0736 Civil Money Penalties;Crown Central Petroleum Corp
RMO 1 GCF-1 Vol#: 1
98H-0873 Civil Money Penalty; Dafam Corp. d/b/a Jean's Super Market
LET 2 Office of Tobacco Programs Vol#: 1
98N-1038 Irradiation in the production, processing, &handling of food
C 1331 Kay C. Karchevski Vol#: 28
C 1334 James M. Sloman Vol#: 28
C 1336 Roger Briand & Carol Bergsma Vol#: 28
C 1337 Iris & Miles Briand Vol#: 28
C 1338 Barbara Sullivan Vol#: 28
C 1340 Candice Stephens Vol#: 28
C 1343 Marti Blodgett Vol#: 28
C 1345 Helen A. Jankoski Vol#: 28
C 1348 Dominican Sisters of Hope Finance Office Vol#: 28
C 1349 Ursuline Sisters of Tildonk Vol#: 28
C 1352 Craig & Cherie Cline Vol#: 28
C 1353 Rosamund Evans Vol#: 28
C 1354 Valorie DeArcangelis Vol#: 28
C 1355 Virginia Hamill Vol#: 28
C 1360 Dorothy T. Byrne Vol#: 28
C 1361 Health Concepts, Inc. Vol#: 28
C 1362 National Consumers League Vol#: 28
C 1363 Timothy Heran, DTR Vol#: 28
C 1364 Pathfinder Film Digital & Internet Media Vol#: 28
C 1367 Sierra Club Ohio Group Vol#: 28
C 1368 Lenore R. Hole Vol#: 28
C 1369 University of Pittsburgh Vol#: 28
C 1371 Veronica E. Riley Vol#: 28
C 1372 Kristine V. Furlong Vol#: 28
C 1373 Konstanze L. Hickey Vol#: 28
EXT 10 Gary A. Patton Vol#: 28
EXT 11 CCNS, Concerned Citizens for Nuclear Saf Vol#: 28
EXT 13 Janice Marshall Vol#: 28
EXT 14 Barbara & Robert M. Goldberg Vol#: 28
98N-1265 Distribution of Compounded Drug Products
C 1972 Rosemary Surles Vol#: 76
C 1973 Susan & Marc Wigler Vol#: 76
C 1975 Patricia Radecki Vol#: 76
C 1976 Mary G. Wickes Vol#: 76
C 1977 Christopher Green Vol#: 76
C 1978 Margaret Shore Vol#: 76
C 1981 Delmar J. Reagan Vol#: 76
C 1983 Kelley DeSousa Vol#: 76
C 1986 Byron Rice & Elisa Lodewijkx Vol#: 76
C 1988 Frances Hedrick Vol#: 76
C 1989 Nancy A. Krisnel Vol#: 76
C 1990 Valerie P. Byrnes Vol#: 76
C 1991 Phyllis Felsher Vol#: 76
C 1992 Vera Maria Seixeria Vol#: 76
C 1994 Janet M. Smith Vol#: 76
C 1995 Nola Nordmarken Vol#: 76
C 1996 Diana R. Morrin Vol#: 76
C 1997 Dorothy M. Cory Vol#: 76
C 1998 Virginia E. Lee Vol#: 76
C 1999 Elizabeth Dickman Vol#: 76
C 2002 Jane Boucher Arnty Vol#: 76
C 2003 Marjory Horton Vol#: 76
98P-0151 Introduction Of Downed Cattle Into The Food Supply
98P-0504 Raw Molluscan Shellfish of Undetectable Levels
98P-0968 Guidance regarding Surimi Ingredient Labeling
C 5 Crystal Ocean Seafood, Inc. Vol#: 1
98P-1194 Withdrawal NADA Approval for Posilac - rBGH
C 101 William Miller, Ph.D. Vol#: 3
99H-0230 Civil Money Penalties;Harold R Draughon,d/b/a Draughon's Sup
CR 1 Office of Tobacco Programs Vol#: 1
99H-0763 Civil Money Penalty; Locke Liquor Store Inc d/b/a Locke Liqu
CS 1 HFA-305 Vol#: 1
OR 1 HF-3 Vol#: 1
99H-1228 Civil Money Penalties;William Thornton,d/b/a The Community
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1286 Civil Money Penalties;Cheshire Oil Co Inc,d/b/a T-Bird Mini
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1287 Civil Money Penalties;Cindor Inc,d/b/a Sack-N-Save
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1288 Civil Money Penalties; Colonial Pharmacy of Contoocook Inc
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1289 Civil Money Penalties; David Canic,d/b/a Union 76 Food Mart
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1290 Civil Money Penalties;E K Inc,d/b/a Lake City Quick Stop
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1291 Civil Money Penalties;Food Lion Inc,d/b/a Food Lion Store
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1292 Civil Money Penalties;Irving Oil Corp (Mainway)d/b/a Pembrok
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1293 Civil Money Penalties;Jim Jorgenson & Jim Orthel,d/b/a Pront
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1294 Civil Money Penalties;Jin Yeol OH,d/b/a Express Line
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1295 Civil Money Penalties;John M Raine,d/b/a John's Texaco Servi
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1296 Civil Money Penalties;Luffman Ent Inc,d/b/a Piney Forest Ex
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1297 Civil Money Penalties;Maurice Bembry,d/b/a Natural Bridge Am
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1298 Civil Money Penalties;MFA Petroleum Co,d/b/a Break Time
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1299 Civil Money Penalties;Riverview Roadhouse L C,d/b/a Rivervie
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1300 Civil Money Penalties;R O Lewis Inc & Ron O Lewis,d/b/a Jahn
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1301 Civil Money Penalties;Shop N Save Warehouse Foods Inc,d/b/a
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1302 Civil Money Penalties;The Hunter Corp of Danville,d/b/a Sunr
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1303 Civil Money Penalties;Walgreen Eastern Co Inc,d/b/a Walgreen
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1304 Civil Money Penalties;Wessels Oil Co Inc,d/b/a Pronto Market
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1305 Civil Money Penalties;William Bainbridge Sr & Lois Bainbridg
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1310 Civil Money Penalties;Young Do Koh & Yeo On Koh,d/b/a La Tie
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1311 Civil Money Penalties; Hani Baskaron & Roger Clark,d/b/a BC
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99N-0438 Contamination ready-to-eat foods associated food prepartion
EXT 1 Cosmetic, Toiletry, and Fragrance Assn Vol#: 2
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock
C 147 Dina S. Lewinter Vol#: 2
C 148 Barbara T. Bingham Vol#: 2
C 151 Elizabeth Stobbs Vol#: 2
99P-0795 Amend regulations on bottled water
C 2 Broadlink Communications Vol#: 1
C 3 Shannon L. Holbrook Vol#: 1