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 March 8, 2000 Table of Contents (Hyper links are part of the Docket title - not all dockets/documents are linked) |
99N-0391 International Guidelines on Vitamin and Mineral supplements * 99P-4613 Revoke the Regulation That Approved Posilac * 00P-0931 Wallac's Neonatal Biotinidase Kit, Models NB-1000, NB-4000 * 00V-0980 Laser light show (Omniscan laser projection system) * |
NWL 1 HFD-7 Vol#: 1
98H-1012 Civil Money Penalties;Handy Food Stores Inc,d/b/a Store #84
CS 1 HFA-305 Vol#: 1
IDF 1 HF-3 Vol#: 1
98H-1102 Civil Money Penalties;Wayne Inlow,d/b/a Inlow's Farm Fresh
CS 1 HFA-305 Vol#: 1
IDF 1 HF-3 Vol#: 1
98N-0518 Communications with State & Foreign Government Officials
NFR 1 Vol#: 1
99D-0296 Formal Meetings with Sponsors/Applicant for PDUFA Products
GDL 2 Guidance Vol#: 1
NAD 2 Vol#: 1
99D-0297 Formal Dispute Resolution Appeals above the Division Level
GDL 2 Guidance Vol#: 1
NAD 2 Vol#: 1
99D-0357 OTC treatment of Herpes Labaialis with Antiviral Agents
GDL 1 Guideline Vol#: 1
NAD 1 HFD-210 Vol#: 1
99H-1013 Civil Money Penalties;G & W Inc,d/b/a Delwood Inc,d/b/a Delw
CS 1 HFA-305 Vol#: 1
IDF 1 HF-3 Vol#: 1
99H-1121 Civil Money Penalties;Paks Inc,d/b/a Paks West Convenience
LET 2 Office of Tobacco Programs Vol#: 1
99H-1377 Civil Money Penalty;David Umoh,dba Shop Fast
CS 1 HFA-305 Vol#: 1
IDF 1 HF-3 Vol#: 1
99H-1475 Civil Money Penalties;Wal-Mart Stores Inc,d/b/a Wal-Mart
CS 1 HFA-305 Vol#: 1
IDF 1 HF-3 Vol#: 1
99H-1739 Civil Money Penalty;Cophers Service Center Inc dba Copher's
LET 2 Office of Tobacco Programs Vol#: 1
99H-1848 Civil Money Penalty;Darryl Williams & Jayneen Williams,dba
CS 1 HFA-305 Vol#: 1
IDF 1 HF-3 Vol#: 1
99H-1883 Civil Money Penalty;Wal-Mart Stores Inc,dba Wal-Mart Store
CS 1 HFA-305 Vol#: 1
IDF 1 HF-3 Vol#: 1
99H-1908 Civil Money Penalty;Patrick Hannigan & Paul Hannigan & Peggy
CS 1 HFA-305 Vol#: 1
IDF 1 HF-3 Vol#: 1
99H-1925 Civil Money Penalty;William E Marion,dba Marion Brothers Gro
CS 1 HFA-305 Vol#: 1
IDF 1 HF-3 Vol#: 1
99H-1958 Civil Money Penalty;Cape Cod Gas Co Inc,dba Cape Cod Gas
CS 1 HFA-305 Vol#: 1
IDF 1 HF-3 Vol#: 1
99H-1967 Civil Money Penalty;Grafton Liquors Inc,dba Grafton Discount
CS 1 HFA-305 Vol#: 1
IDF 1 HF-3 Vol#: 1
99H-1987 Civil Money Penalty;Bruce Henderson Petroleum Co Inc,dba Fin
CS 1 HFA-305 Vol#: 1
IDF 1 HF-3 Vol#: 1
99H-1995 Civil Money Penalty;Bruno's Inc,dba Food Max
CS 1 HFA-305 Vol#: 1
IDF 1 HF-3 Vol#: 1
99H-1999 Civil Money Penalty;Hope Seymour,dba Seymour's Food Store
CS 1 HFA-305 Vol#: 1
IDF 1 HF-3 Vol#: 1
99H-2007 Civil Money Penalty;Randy Crawford,dba Crawford's Amoco Food
CS 1 HFA-305 Vol#: 1
IDF 1 HF-3 Vol#: 1
99H-2008 Civil Money Penalty;Jim Morgan,dba Jiffy Jim's 1-Stop
CS 1 HFA-305 Vol#: 1
IDF 1 HF-3 Vol#: 1
99H-2009 Civil Money Penalty;Sandy Melton,dba Sandy Girl's
CS 1 HFA-305 Vol#: 1
IDF 1 HF-3 Vol#: 1
99H-2017 Civil Money Penalty;Ali Khalil,dba Magnolia Mart
CS 1 HFA-305 Vol#: 1
IDF 1 HF-3 Vol#: 1
99H-2020 Civil Money Penalty;Joe Holmes,dba Joe's Grocery Spur
CS 1 HFA-305 Vol#: 1
IDF 1 HF-3 Vol#: 1
99H-2024 Civil Money Penalty;Pautla Inc,dba 4-way Convenience Store
CS 1 HFA-305 Vol#: 1
IDF 1 HF-3 Vol#: 1
99H-2037 Civil Money Penalty;Julius Donald Hall,dba Red Apple Chevron
CS 1 HFA-305 Vol#: 1
IDF 1 HF-3 Vol#: 1
99H-2044 Civil Money Penalty; Krikor Partiguian & Martha Partiguian
CS 1 HFA-305 Vol#: 1
IDF 1 HF-3 Vol#: 1
99H-2861 Civil Money Penalty;Hyder's Kountry Kubbard Inc,dba Kountry
HER 1 Hyders Kountry Kubbard Inc Vol#: 1
99H-4365 Civil Money Penalty;June Ent Inc,dba Carrollton Exxon
LET 2 Office of Tobacco Programs Vol#: 1
99H-4749 Civil Money Penalty;Gayle L Macy,dba Midway Village & Grocer
LET 2 Office of Tobacco Programs Vol#: 1
99H-4781 Civil Money Penalty;Asif Virani,dba Finer Foods
LET 2 Office of Tobacco Programs Vol#: 1
99H-5025 Civil Money Penalty;Weigel's Inc,dba Weigel's #7
CS 1 HFA-305 Vol#: 1
IDF 1 HF-3 Vol#: 1
99H-5085 Civil Money Penalty;Wexford Bridge Corporation,dba Southern
CR 1 GCF-1 Vol#: 1
LET 2 Office of Tobacco Programs Vol#: 1
99H-5096 Civil Money Penalty;Sal's Party Store Inc,dba Sal's Party St
LET 2 Office of Tobacco Programs Vol#: 1
99H-5251 Civil Money Penalty;Discount Smoke Shop,Inc;dba Discount Smo
MO 1 Discount Smoke Shop Vol#: 1
99H-5342 Civil Money Penalty;Carl E. Larson Jr,dba Sunshine Corners
LET 2 Office of Tobacco Programs Vol#: 1
99H-5406 Civil Money Penalty;James W. Suh;dba Sun Grocery
LET 2 Office of Tobacco Programs Vol#: 1
99H-5408 Civil Money Penalty;Holyoke News Co., Inc;dba Amherst Newsro
LET 2 Office of Tobacco Programs Vol#: 1
99H-5470 Civil Money Penalty;John Franklin and Anthony Fanelli;dba
CR 1 GCF-1 Vol#: 1
LET 2 Office of Tobacco Programs Vol#: 1
99H-5504 Civil Money Penalty;Bennie S. Montague;dba Poplar Creek Stor
LET 2 Office of Tobacco Programs Vol#: 1
99H-5533 Civil Money Penalty;Jim & Dorothy,Inc;dba Bay Shore Food Mar
CS 1 HFA-305 Vol#: 1
OR 1 HF-3 Vol#: 1
99H-5580 Civil Money Penalty;Donovan Woodburn, Jr;dba Hop & Sack #22
LET 2 Office of Tobacco Programs Vol#: 1
99N-0391 International Guidelines on Vitamin and Mineral supplements
C 111 Robert G. Rollins Vol#: 6
99N-2553 Agency Collection Activities; Citizen Petition
NAL 1 Vol#: 1
99N-2875 Blood Establishment Registration /Product Listing Form 2830
N 3 Vol#: 1
S 1 Supporting Statement Vol#: 1
99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings
C 2452 Caroline Lippincott Vol#: 222
C 2453 Mr & Mrs J Gerstley Vol#: 222
C 2454 Patricia Spencer Vol#: 222
C 2455 Carie Zierer Vol#: 222
C 2456 Terri Sheridan Vol#: 222
C 2457 James P Cassidy Vol#: 222
C 2458 Kosoma K Skaggs Vol#: 222
C 2459 Michael Cyrek Vol#: 222
C 2460 Cynthia Louis Vol#: 222
C 2461 Duff Siler Jr Vol#: 222
C 2462 Deb Jones Vol#: 222
C 2463 James Daniels Vol#: 222
C 2464 Wanda Crawford Vol#: 222
C 2465 Judy Olmstead Vol#: 222
C 2466 Dorothy Malloy Vol#: 222
C 2467 W Sommermeyer Vol#: 222
C 2468 Joan J Randall Vol#: 222
C 2469 Marge Piercy Vol#: 222
C 2470 Florence E Ward Vol#: 222
C 2471 Lois Pratt Vol#: 222
C 2472 Kimberley S Matthews Vol#: 222
C 2473 Lynn & Ruth Guthrie Vol#: 222
C 2474 David Balsbaugh Vol#: 222
C 2475 Mary M Anderson Vol#: 222
C 2476 Mr & Mrs Stanley T Haramoto Vol#: 222
C 2477 Mary Tomlinson Vol#: 222
C 2478 David B Watts Vol#: 222
C 2479 David Gross Vol#: 222
C 2480 Carl L Timpe Vol#: 222
C 2481 John Koier Vol#: 222
C 2482 Martha Farmwald Vol#: 222
C 2483 Mary Lippert Vol#: 222
C 2484 Anne Swerdlove Vol#: 222
C 2485 A Yvonne Jingle Vol#: 222
C 2486 Form letter count 35 Vol#: 226
C 2487 Form letter count 43 Vol#: 227
C 2488 Form letter count 33 Vol#: 228
C 2489 Form letter count 163 Vol#: 229
C 2490 Cathy M Gill Vol#: 223
C 2491 Mr & Mrs Edwin Friend Vol#: 223
C 2492 Beatrice R Quisenberry Skinner Vol#: 223
C 2493 Marie K Shtt Vol#: 223
C 2494 Maria Prats Vol#: 223
C 2495 Deborah W Kuehn Vol#: 223
C 2496 Harold W Payne Vol#: 223
C 2497 Shannon Correen Massena Vol#: 223
C 2498 B Gardon Vol#: 223
C 2499 Lauretta E Foss Vol#: 223
C 2500 Nancy Clark Vol#: 223
C 2501 Karla S Havens Vol#: 223
C 2502 Lesley Mack Vol#: 223
C 2503 James C Dolweck Vol#: 223
C 2504 Stephen F Bruske Vol#: 223
C 2505 Estella L Richardson Vol#: 223
C 2506 Carol M Buchea Vol#: 223
C 2507 Zelpha Boyd Vol#: 223
EC 1701 none Vol#: 208
EC 1702 Number Not Used Vol#: 208
EC 1703 Ms. Marilyn Fitzmaurice Vol#: 208
99P-4613 Revoke the Regulation That Approved Posilac
EMC 1058 Carl Lindstrom Vol#: 12
EMC 1059 Michele or Don Wynn Vol#: 12
EMC 1060 Veronica Oliva Vol#: 12
EMC 1061 Mary F. Ables Vol#: 12
EMC 1062 Madeleine Cole Vol#: 12
EMC 1063 Roberta Spieckerman Vol#: 12
EMC 1064 Cheryl R. McHale Vol#: 12
EMC 1065 Sydney Gurewitz Clemens Vol#: 12
EMC 1066 Maril Crabtree Vol#: 12
EMC 1067 Jeanne & Steve McKinney Vol#: 12
EMC 1068 Deanna Apfel Vol#: 12
EMC 1069 Christine Zomorodian Vol#: 12
EMC 1070 Laura McKinney & David Blyn Vol#: 12
EMC 1072 Theresa Scripps Vol#: 12
EMC 1075 Donald R. Frank Vol#: 12
EMC 1076 Deirdre Elmansoumi Vol#: 12
EMC 1077 Jane Hunnicutt Vol#: 12
EMC 1078 Dragonfly Dream Vol#: 12
EMC 1079 Eduardo Parra Vol#: 12
EMC 1080 Cherie Blackfeather Vol#: 12
EMC 1081 Cynthie Washburn Vol#: 12
EMC 1083 Sandra Stanton Vol#: 12
EMC 1084 Doris P. Saxer Vol#: 12
EMC 1085 Katja Hernandez Vol#: 13
EMC 1086 Barbara Ledig Vol#: 13
EMC 1087 Debi Slatkin Vol#: 13
EMC 1089 Norma Peters Vol#: 13
EMC 1092 Doris K. Ellis Vol#: 13
EMC 1094 Harry Caylor Vol#: 13
EMC 1095 Harry Caylor Vol#: 13
EMC 1096 Sandra Stenoff Vol#: 13
EMC 1097 Stella Monday Vol#: 13
EMC 1098 Caprice Arenth Vol#: 13
EMC 1099 Cindy L. Rupert Vol#: 13
EMC 1100 Rachel Lagodka Vol#: 13
EMC 1101 Judy Raymond Vol#: 13
EMC 1103 David Pearson & Dannelle Sirrine Vol#: 13
EMC 1104 Amy Ruth Prentiss Vol#: 13
EMC 1105 Mary O. Wondra Vol#: 13
EMC 1107 Tina Mauldin, RN Vol#: 13
EMC 1108 David Pearson & Dannelle Sirrine Vol#: 13
EMC 1109 Joanne Richards Vol#: 13
EMC 1110 Joanne Richards Vol#: 13
EMC 1111 Seth & Sandy Basker Vol#: 13
EMC 1112 Jennie Orvino Vol#: 13
EMC 1115 Dr. Doris J. Rapp, M.D. Vol#: 13
EMC 1116 Shahzadi Thomas Vol#: 13
EMC 1117 Michele French Vol#: 13
EMC 1118 Charles Parselle Vol#: 13
EMC 1119 D. & M. McCarthy Vol#: 13
EMC 1120 Joel Hirshberg Vol#: 13
EMC 1121 Don Pasquella Vol#: 13
EMC 1122 Catherine Carter Vol#: 13
EMC 1123 Thomas M. Zimmer Vol#: 13
EMC 1124 Joy Hirshberg Vol#: 13
EMC 1126 Nataliya Averyanova Vol#: 13
EMC 1128 Vanessa Vidal Vol#: 13
EMC 1129 Cynthia Rama Vol#: 13
00B-0108 Reclassify Antimicrobial Susceptibility Devices ClassIIItoII
N 1 HFZ-215 Vol#: 1
REF 1 References Vol#: 1
00D-0109 Assessment of Antimicrobial Susceptibility Devices
GDL 1 Guideline Vol#: 1
NAD 1 HFZ-220 Vol#: 1
00F-0812 "Inhibitor of yeast", for the safe of (DMDC)
NFL 1 Vol#: 1
00F-0813 Components of paper and paperboard incontact with aqueous an
NFL 1 Vol#: 1
00H-0056 Civil Money Penalty;Kyong O.Seo Cho;dba Manna One Deli
ANS 2 Manna One Deli Vol#: 1
00H-0096 Civil Money Penalty;Paul Lautigar;dba ICO Convenience Store
LET 2 Office of Tobacco Programs Vol#: 1
00H-0097 Civil Money Penalty;Pride Convenience,Inc;dba Pride
LET 2 Office of Tobacco Programs Vol#: 1
00H-0124 Welshie's Enterprises,Inc and James Welsh,Sr;dba Welshie's
LET 2 Office of Tobacco Programs Vol#: 1
00H-0145 Civil Money Penalty;Debra M. Phoebus,dba 7-Eleven #18208
LET 2 Office of Tobacco Programs Vol#: 1
00H-0169 Civil Money Penalty;Pride Convenience, Inc;dba Pride
LET 2 Office of Tobacco Programs Vol#: 1
00H-0181 Civil Money Penalty;Freestate Petroleum Corporation;dba Free
LET 2 Office of Tobacco Programs Vol#: 1
00H-0197 Civil Money Penalty;Randy Nealy;dba Nealy's Village Mart
LET 2 Office of Tobacco Programs Vol#: 1
00H-0231 Civil Money Penalty;Tedeschi Food Shops Inc,dba Tedeschi Foo
ANS 1 Tedeschi Food Shop #108 Vol#: 1
00H-0250 Civil Money Penalty;Dean Bacon and Ann Bacon,dba Maurie's
ANS 1 Dean Bacon & Ann Bacon Vol#: 1
00H-0302 Civil Money Penalty;Wallis Oil Co & William Wallis, dba Mobi
LET 2 Office of Tobacco Programs Vol#: 1
00H-0307 Civil Money Penalty;Charles Mayo,dba C J'S Exxon
ANS 1 CJ's Exxon Vol#: 1
00H-0328 Civil Money Penalty;Glenn Oil Company,dba Sheridan 66
ANS 1 Genn Oil Co Vol#: 1
00H-0348 Civil Money Penalty;Hop & Sack #20 Inc,dba Hop & Sack #20
ANS 1 Hop & sack #20 Inc Vol#: 1
00H-0462 Civil Money Penalty;Tracy Ferry Marina Inc,dba Tracy Ferry
ANS 1 Tracy Ferry Marina Vol#: 1
00H-0575 Civil Money Penalty;Storing-Curtis Inc,dba Wikieup Trading P
ANS 1 Storing Curtis Inc Vol#: 1
00H-0595 Civil Money Penalty;G Whittaker's Inc,dba Whit's Little Stor
ANS 1 G Whittakers Inc Vol#: 1
LET 2 Office of Tobacco Programs Vol#: 1
00H-0620 Civil Money Penalty;Waco Oil Company Inc,dba Waco Oil Compan
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0621 Civil Money Penalty;Bill Weatherby,dba Highway 82 Liquor Sto
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0622 Civil Money Penalty;Mary L White,dba Ingrams Mill Grocery
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0655 Civil Money Penalty;Calaway Enterprises Inc and Darren Calaw
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0656 Civil Money Penalty;Westcoast hotels Inc,dba The Grove Hotel
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0657 Civil Money Penalty;Larry and Linda Jarnagan,dba Chester Mer
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0658 Civil Money Penalty;Robert Ross,dba Ross Grocery
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0659 Civil Money Penalty;Tim & Tom's Speedy Market Inc,dba Tim &
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0660 Civil Money Penalty;Leonard Z Ross,dba LZ Grocery & Service
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0661 Civil Money Penalty;Lee Dale Fairchild,dba Dale Fairchild Gr
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0662 Civil Money Penalty;Bret Ojala and Lori Ojala,dba Buddy's Ta
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0663 Civil Money Penalty;Jerry Grooms,dba Airport Tobacco
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0664 Civil Money Penalty;Wal-Mart Stores Inc,dba Wal-Mart Store #
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0665 Civil Money Penalty;Bobby E Daggs,dba Bob's Grocery & Deli
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0666 Civil Money Penalty;Tobacco Superstores Inc,dba Tobacco Supe
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0667 Civil Money Penalty;Billy Andrews and Barabara Andrews,dba H
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0668 Civil Money Penalty;ST Investments Inc,dba Franklin Chevron
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0736 Civil Money Penalty;Patrick Kelly,dba Fairway Foods
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0737 Civil Money Penalty;Mortadella LLC,dba Mortadella Grocery
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0738 Civil Money Penalty;Joseph Chilcoat and Pamela Chilcoat,dba
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0739 Civil Money Penalty;Uselton Oil Co Inc,dba USCO #4
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0740 Civil Money Penalty;Huggy Bear Inc,dba Harborview Variety
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00N-0018 Reclassification of the knee joint Patellofemorotibal Metal
N 1 Vol#: 1
00N-0725 ''Inerstate Shellfish Dealers Certificate
N 1 Vol#: 1
00N-0726 General Licensing Provisions:Change to an Approved Applicati
N 1 Vol#: 1
00P-0931 Wallac's Neonatal Biotinidase Kit, Models NB-1000, NB-4000
CCP 1 Perkin Elmer Wallac Inc. Vol#: 1
00V-0980 Laser light show (Omniscan laser projection system)