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 18, 1999

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 ]

 
91N-0281 Effect date for PMA Silicone Inflatable Breast Prosthesis *
98N-0562 Civil Money Penalties; Rajaram K Matkari *
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 *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
99P-2850 Paricalcitol to Priority List of Approved Drugs *
77N-334S Topical Otic Drug Products OTC Human Use; Swimmer Ear

NPR 2 Vol#: 5

91N-0281 Effect date for PMA Silicone Inflatable Breast Prosthesis

PDN 2 HFZ-1 to Hyman Phelps & McNamara Vol#: 13

96N-0144 OTC-Colloidal Silver Ingredients or Silver Salts

NFR 1 Vol#: 7

97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD

GDL 2 Guidance Vol#: 1

NAD 2 Vol#: 1

98D-0374 International Conference on Harmonisation; Draft Guidance

NAD 2 HFD-210 Vol#: 1

98D-0449 Inspection of Medical Device Manufacturers

GDL 2 Guidance Vol#: 1

NAD 2 Vol#: 1

98H-0990 Civil Money Penalties;Rick Sweet, d/b/a Amoco

LET 3 Office of Tobacco Programs Vol#: 1

98H-1115 Civil Money Penalties;Milo Jackson,d/b/a MJ's Corner Store

MO 2 GCF-1 Vol#: 1

98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding;

C 145 The Edelson Ctr for Environ & Prev Med Vol#: 19

98N-0222 Dissemination of Information on Unapproved/New Uses

N 3 Vol#: 4

98N-0562 Civil Money Penalties; Rajaram K Matkari

M 1 Denver District Vol#: 1

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

C 4665 Renee Bloch Vol#: 114

C 4666 C. M. Shepherd Vol#: 114

C 4667 Jason E. Sigler Vol#: 114

C 4668 Anne V. Sigler Vol#: 114

C 4669 Organic Consumers Assn. Vol#: 114

C 4670 Michael Reynolds Vol#: 114

C 4671 Eunice Thaeler Vol#: 114

EXT 40 Juna Snow Vol#: 114

98N-1265 Distribution of Compounded Drug Products

C 5970 Margaret Juess Vol#: 169

C 5971 Carmen W. O'Connor Vol#: 169

C 5972 Maya Mayer Vol#: 169

C 5973 C. G. Pelovin Vol#: 169

C 5974 James Friedman Vol#: 169

C 5975 Judith Moore Vol#: 169

C 5976 Linda L. Hines Vol#: 169

C 5977 Amelia Hrabb Vol#: 169

C 5978 Suzanne M. Mercer Vol#: 169

C 5979 Kathleen V. Price Vol#: 169

C 5980 Carol Godsey Vol#: 169

C 5981 Ruth Richardson Vol#: 169

C 5982 Barbara Johnson Vol#: 169

C 5983 Valerie Welch Vol#: 169

C 5984 Carolyn Kesanen Vol#: 169

C 5985 Jeanne Wilson Vol#: 169

C 5986 Katherine A. Allen Vol#: 169

C 5987 Paula Brozdon Vol#: 169

C 5988 Candida Fraze Vol#: 169

C 5989 Nora Poeter Boskoff Vol#: 169

C 5990 Illegible Vol#: 169

C 5991 Ronni Stewart Vol#: 169

C 5992 S. Shahriari Vol#: 169

C 5993 Brenda S. Futtle Vol#: 169

C 5994 Miriam S. Michel Vol#: 169

C 5995 Ellen Kazanoff Vol#: 169

C 5996 Charlene J. Pieper Vol#: 169

C 5997 Barbara J. Barker Vol#: 169

C 5998 Sheila Eisenbach Vol#: 169

C 5999 Mrs. Jan E. Merz Vol#: 169

C 6000 Michelle L. Garner Vol#: 169

C 6001 Connie E. Hetrick Vol#: 169

C 6002 Mary Belliveau Vol#: 169

C 6003 Sylvia D. Martin Vol#: 169

C 6004 Eunice Day-Smith Vol#: 169

C 6005 Janice Secor Vol#: 169

C 6006 M. Neils Fennessy Vol#: 169

C 6007 Ikuko Taniguchi Vol#: 169

C 6008 Sandy Ayers Vol#: 169

C 6009 K. Alton Vol#: 169

98P-0151 Introduction Of Downed Cattle Into The Food Supply

C 2232 Heather E. Burns Vol#: 64

C 2233 Jean Bech Vol#: 64

99D-2405 Information Request and Discipline Review Letter

GDL 1 Guidance Vol#: 1

NAD 1 Vol#: 1

99D-2636 Guidance for Industry on Levothyroxine Sodium

GDL 1 Guidance Vol#: 1

NAD 1 HFD-210 Vol#: 1

99F-0001 Filing of Food Additive Petition for Sucralose

NFR 1 Vol#: 1

99H-0170 Civil Money Penalties; WTSU Inc,d/b/a Wades Texaco Serv Sta

ANS 1 WTSU Inc Vol#: 1

99H-0515 Civil Money Penalties;Fulciniti Inc,d/b/a Fulciniti's Market

ANS 1 Fulcinity Inc Vol#: 1

99H-0675 Civil Money Penalties;Hamrick's Inc,d/b/a Carousel Liquor

TS 1 GCF-1 Vol#: 1

99H-0678 Civil Money Penalty;Lab Marketing L C,dba Nothin' Butt Smoke

ANS 1 Lab Marketing L C,dba Nothin' Butt Smoke Vol#: 1

99H-0767 Civil Money Penalty; Waring Oil Co Inc d/b/a Interstate Food

LET 2 Office of Tobacco Programs Vol#: 1

99H-0973 Civil Money Penalties;Michale Goonan,d/b/a Jane Alden Dairy

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

99H-1182 Civil Money Penalties;Corborn's Inc,d/b/a Cash Wise

LET 2 Office of Tobacco Programs Vol#: 1

99H-1185 Civil Money Penalties;Krakow Store Inc,d/b/a Krakow Store

LET 2 Office of Tobacco Programs Vol#: 1

99H-1194 Civil Money Penalties;Larry Bunch,d/b/a Galena Country Corne

LET 2 Office of Tobacco Programs Vol#: 1

99H-1237 Civil Money Penalties;Steve & Greta Hudson,d/b/a Steve's Cor

LET 2 Office of Tobacco Programs Vol#: 1

99H-1258 Civil Money Penalties;Vista Food Market Inc,d/b/a Vista Food

LET 2 Office of Tobacco Programs Vol#: 1

99H-1560 Civil Money Penalty;Paul Dever dba Dogwood General Store

LET 2 Office of Tobacco Programs Vol#: 1

99H-1806 Civil Money Penalty;Kroger Corporation,dba King Soopers

ANS 2 Kroger Corporation,dba King Soopers Vol#: 1

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

LET 2 Office of Tobacco Programs Vol#: 1

99H-1977 Civil Money Penalty;Don Colcord,dba The Apothecary Shoppe

LET 2 Office of Tobacco Programs Vol#: 1

99H-2041 Civil Money Penalty;Leotti Enterprises Co,dba Conoco

LET 2 Office of Tobacco Programs Vol#: 1

99H-2054 Civil Money Penalty;Rod's Liquors Inc,dba Rod's Liquors

LET 2 Office of Tobacco Programs Vol#: 1

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

LET 2 Office of Tobacco Programs Vol#: 1

99H-2061 Civil Money Penalty;Daniel L Loxtercamp,dba Super America

LET 2 Office of Tobacco Programs Vol#: 1

99H-2104 Civil Money Penalty;Waring Oil Co,dba Interstate Station #20

LET 2 Office of Tobacco Programs Vol#: 1

99H-2158 Civil Money Penalty;Paul Lowery,dba Short Stop Market

ANS 1 Short Stop Market Vol#: 1

99H-2164 Civil Money Penalty;Ultramar Diamond Shamrock,dba Diamond Sh

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-2207 Civil Money Penalty;Waring Oil Co,dba Interstate Station 49

LET 2 Office of Tobacco Programs Vol#: 1

99H-2232 Civil Money Penalty;JFM Inc,dba Jr Food Mart #10

ANS 1 JFM Inc Vol#: 1

99H-2233 Civil Money Penalty;Paul Lowery,dba Short Stop Travel Ctr II

ANS 1 Short Stop Travel Center II Vol#: 1

99H-2251 Civil Money Penalty;Francisco Espindola,dba La Flor

ANS 1 La Flor Inc Vol#: 1

99H-2253 Civil Money Penalty;Aultman Ent Inc,dba Super Valu #71804

ANS 1 Aultman Ent Inc Vol#: 1

99H-2261 Civil Money Penalty;Roy Gatlin,dba R & K Grocery & Grill

ANS 1 R & K Grocery & Grill Vol#: 1

99H-2262 Civil Money Penalty;Brad Williams & Pam Williams,dba William

ANS 1 Williams Country Grocery Vol#: 1

99H-2352 Civil Money Penalty;Daniel R Coty Inc,dba I 95 Mobil

ANS 1 Daniel R Coty Inc Vol#: 1

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

ANS 1 Ratliff Grocery Inc Vol#: 1

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

ANS 1 McArdle Co Inc Vol#: 1

99H-2415 Civil Money Penalty;Steven Croteau & Jennifer Fazio,dba Smil

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

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

LET 2 Office of Tobacco Programs Vol#: 1

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

ANS 1 Rite Aid Corporation Vol#: 1

99H-2476 Civil Money Penalty;Ken C. Lyles,dba BP Service Center

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

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

LET 2 Office of Tobacco Programs Vol#: 1

99H-2516 Civil Money Penalty;Taneycomo Market & Campground Inc,dba

ANS 1 Taneycomo Markett & Campground Inc Vol#: 1

99H-2518 Civil Money Penalty;Cheng Kwong Seafood Market Inc,dba Cheng

ANS 1 Cheng-Kwong Seafood Market Inc Vol#: 1

99H-2525 Civil Money Penalty;Jim Nassif,dba Tatnuck Square Getty Inc

ANS 1 Tatnack Square Getty Inc Vol#: 1

99H-2555 civil Money Penalty;7-Eleven Inc,dba 7-Eleven #26933

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

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

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2557 Civil Money Penalty;Mike Brawner,dba A J's Food Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2558 Civil Money Penalty;Circle K Stores Inc,dba Circle K

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2559 Civil Money Penalty;Circle K Stores Inc,dba Circle K #1251

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2560 CIVIL Money Penalty;CVS Pharmacy Inc,dba CVS Pharmacy #58

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#:

99H-2561 Civil Money Penalty;DB Marketing Company Inc,dba DB Mart #16

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2562 Civil Money Penalty;Doug's Short Stop Inc,dba Doug's Short S

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2563 Civil Money Penalty;Robert Foster & Evelyn Foster,dba Big

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2564 Civil Money Penalty;Friendly Express Inc,dba Friendly Expres

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

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

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2566 Civil Money Penalty;Granite Super Market Inc,dba Almichs Sup

ANS 1 Granite Super Market Inc,dba Almich's Vol#: 1

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2567 Civil Money Penalty;Greenwood Liquor Center Inc,dba Greenwoo

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2568 Civil Money Penalty;J&K Gas Inc,dba Exxon Dunkin Donuts

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2569 Civil Money Penalty;Larry Liquors Inc,dba Larry's Liquors

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2570 Civil Money Penalty;Lipscomb Oil Company Inc,dba Tiger Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2571 Civil Money Penalty;Maxi Drug Inc,dba Brooks Pharmacy

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2572 Civil Money Penalty;Merit Oil Corporation,dba Merit Oil #58

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2573 Civil Money Penalty;Ports Petroleum Company Inc,dba Fuel Mar

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2574 Civil Money Penalty;R & L Real Estate Inc,dba Andy's 66 Mini

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2575 Civil Money Penalty;Roger Rains,dba Rains Old Home Cafe & Ba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

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

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2577 Civil Money Penalty;Davinder Singh,dba Super Buy Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2578 Civil Money Penalty;Supervalu Inc,dba Cub Foods

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2579 Civil Money Penalty;Texaco Inc,dba Texaco Star Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

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

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2581 Civil Money Penalty;Phil Troutwine,dba Buhl Short Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2582 Civil Money Penalty;Wal-Mart Stores Inc,dba Wal-Mart Superce

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

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

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2589 Civil Money Penalty;MFA Petroleum Company.dba Marston Fuel

LET 2 Office of Tobacco Programs Vol#: 1

99H-2600 Civil Money Penalty;Dixie Oil Company of Alabama Inc,dba Dix

ANS 1 Dixie Oil Co of Ala. Inc Vol#: 1

99N-0926 Regulations under the Federal Import Milk Act;Agency Inform

NCR 2 Vol#: 1

99N-1010 Investigational New Drug Regulations; Information Collection

N 2 Vol#: 1

99N-2553 Solicits Comments on Reporting Requirements

N 1 Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1503 Helen Just Vol#: 23

C 1504 Michael Leong Vol#: 23

C 1505 Frederick L Little Vol#: 23

C 1506 Tam H Greene Vol#: 23

C 1507 C Stecher Vol#: 23

C 1508 Donna Kuras Vol#: 23

C 1509 Ruth Niswander Vol#: 23

C 1510 Guy Gray Vol#: 23

C 1511 Wendy Loren Vol#: 23

C 1512 Richard & Andrea Noto Vol#: 23

C 1513 Lillian Perlman Vol#: 23

C 1514 Susannah F Prindle Vol#: 23

C 1515 John Zachai Vol#: 23

C 1516 Constance J Masters Vol#: 23

C 1517 Daniel M De Augustine Vol#: 23

C 1518 Samuel W Parnes Vol#: 23

C 1519 Philip B Lorenz Vol#: 23

C 1520 Bill & Marilyn Voorhies Vol#: 23

C 1521 Antoinette Pantelleria Vol#: 23

C 1522 Karen K Bendig Vol#: 23

C 1523 Christine N Weigand Vol#: 23

C 1524 Lee Doan Vol#: 23

C 1525 Richard Elrauch Vol#: 23

C 1526 William E Robinson Vol#: 23

C 1527 Mary McAmis Smith Vol#: 23

C 1528 Rosemary E Meyers Vol#: 23

C 1529 Don Schrader Vol#: 23

C 1530 Connie Kiosse Vol#: 23

C 1531 Robert & Marie Fehribach Vol#: 23

C 1532 J Gottlieb MD Vol#: 23

C 1533 Suzanne Williams Vol#: 23

EC 25 Kate Simpson Vol#: 23

EC 26 Reese E Forbes Vol#: 23

EC 27 William Frey Vol#: 23

EC 28 Noemie Maxwell Vol#: 23

EC 29 Mark Freeman Vol#: 23

EC 30 Sean Brient Vol#: 23

EC 31 Marian Cruz Vol#: 23

EC 32 Tamara Rivet Vol#: 23

EC 33 Bert Miller Vol#: 23

EC 34 Peter Oursoff Vol#: 23

EC 35 Stella M Capek Vol#: 23

EC 36 H Teter Vol#: 23

EC 37 Rick Dudley Vol#: 23

EC 38 Lois Kulakowski Vol#: 23

EC 39 Annelise Kelly Vol#: 23

EC 40 Steve Gross Vol#: 23

EC 41 Wesrita Vol#: 23

99P-2850 Paricalcitol to Priority List of Approved Drugs

CP 1 Abbott Hospital Products Division Vol#: 1