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DOCKETS ENTERED on APRIL 15, 1999
Updated as of 11:55 am, April 22, 1999. The following documents were entered at the Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860 and are hyperlinked to the actual comments/letters/reports as indicated below.
77N-0085 Saccharin and Its Salts
CA 27072 S H Solomon Vol#: 425
CA 27073 J H Barrier Vol#: 425
CA 27074 M Barrier Vol#: 425
CA 27075 C Anderson Vol#: 425
CA 27076 G Siewiet Vol#: 425
CA 27077 J H Barrier Vol#: 425
CA 27078 P Reamer Vol#: 425
CA 27079 B Dewey Vol#: 425
CA 27080 H S Petersen Vol#: 425
CA 27081 H Thomas Vol#: 425
CA 27082 C Beckwith Vol#: 425
CA 27083 C Wessell Vol#: 425
CA 27084 J Schulitz Vol#: 425
CA 27085 R E Mumma Vol#: 425
CA 27086 M Taylor Vol#: 425
CA 27087 E W Pearson Vol#: 425
CA 27088 D B Wilkins Vol#: 425
CA 27089 G Bruce Vol#: 425
CA 27090 M H Bronner Vol#: 425
CA 27091 S K Eiland Vol#: 425
CA 27092 B J Weintz Vol#: 425
CA 27093 G J Chute Vol#: 425
CA 27094 D E Stoner Vol#: 425
CA 27095 J D Ochs Vol#: 425
CA 27096 L S July Vol#: 425
CA 27097 W M Higdon Vol#: 425
CA 27098 D M Poche RPh Vol#: 425
CA 27100 N Walden Vol#: 426
CA 27101 W E Allison Vol#: 426
CA 27102 E W Seager Vol#: 426
CA 27103 J S Davis Vol#: 426
CA 27104 W M Farley Vol#: 426
CA 27105 J Howard Vol#: 426
CA 27106 W W Morgan Vol#: 426
CA 27107 M Landrum Vol#: 426
CA 27108 H Connelly Vol#: 426
CA 27109 J R Holmes Vol#: 426
CA 27110 D R Sharp Vol#: 426
CA 27111 N A Grieg Vol#: 426
CA 27112 K Demert Vol#: 426
CA 27113 F G Cooksey Vol#: 426
CA 27114 C H Norris Vol#: 426
CA 27115 D E Hartzler Vol#: 426
CA 27116 A L Armistead Vol#: 426
CA 27117 L A Reich Vol#: 426
CA 27118 T G Yoaka Vol#: 426
CA 27119 C R Wilson Vol#: 426
CA 27120 B A Kothmann Vol#: 426
CA 27121 L H Robb Vol#: 426
CA 27122 R Drumond Vol#: 426
CA 27123 W W Groner Vol#: 426
CA 27124 T M Henry Vol#: 426
CA 27125 H Starus Vol#: 426
CA 27126 J Zwick Vol#: 426
CA 27127 E Schrackenberg Vol#: 426
CA 27128 J S Smith Vol#: 426
CA 27129 R H Lovett Vol#: 426
CA 27130 A Smith Vol#: 426
CA 27131 H Hitzfeld Vol#: 426
CA 27132 M G Aguillard Vol#: 426
CA 27133 P E Perry Vol#: 426
CA 27134 E G Anderson Vol#: 426
CA 27135 B Hughes Vol#: 426
CA 27136 D Shelton Vol#: 426
78N-0038 Sunscreen Drug Products
91N-0281 Effect date for PMA Silicone Inflatable Breast Prosthesis
TA 1 Threshold Assessment Vol#: 13
94F-0405 Safe use of aspartame as general purpose sweetener
96N-0135 Protein Derived from Ruminants Prohibited in Ruminant Feed
C 1685 Betty Trentlyon Vol#: 86
C 1686 Ida R. Simpson Vol#: 86
C 1688 Maureen B. O. Reilly Vol#: 86
98D-0785 Medical imaging drugs and biologics
C 13 Council on Radionuclides & Radiopharmace Vol#: 2
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa
C 44 Kwan Kew Lai, M.D. Vol#: 2
C 45 Animal Welfare Institute Vol#: 2
98F-0705 Antioxidants and/or stabilizers for polymers
NWL 1 Ciba Specialty Chemicals Corp Vol#: 1
98H-0410 Civil Money Penalties;Grant L. Leavell,d/b/a/ Grant's Market
LET 3 Office of Tobacco Progams (HF-11) Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-0533 Civil Money Penalties; Idalia Tobar,d/b/a Grand Perkins Mark
LET 4 Office of Tobacco Progams (HF-11) Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-0535 Civil Money Penalties;William A. Lennicx,Sr. Inc.d/b/a Kwik
LET 2 Office of Tobacco Progams (HF-11) Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-0539 Civil Money Penalties;Gene S.Wilson Inc,d/b/a Bonnie Brae Co
LET 3 Office of Tobacco Progams (HF-11) Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-0540 Civil Money Penalties;Charla Huntley,d/b/a Acme Liquor Store
LET 4 Office of Tobacco Progams (HF-11) Vol#: 1
SET 1 GCF-1 Vol#: 1
SET 2 GCF-1 Vol#: 1
98H-0555 Civil Money Penalties;Mayflower Food Stores Inc. Store No. 2
LET 4 Office of Tobacco Progams (HF-11) Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-0560 Civil Money Penalties;Total Petroleum Inc,d/b/a Total Petrol
LET 4 Office of Tobacco Progams (HF-11) Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-0685 Civil Money Penalties;Crown Central Petroleum,d/b/a Crown
MO 2 Crown Central Petroleum Corp Vol#: 1
98H-0688 Civil Money Penalties;Fast Fare Inc,d/b/a Fast Fare Store
MO 2 Crown Central Petroleum Corp Vol#: 1
98H-1080 Civil Money Penalties;Larry W Denley,d/b/a Coffeeville Groce
LET 2 Office of Tobacco Progams (HF-11) Vol#: 1
98H-1202 Civil Money Penalties; Lake Sammamish Mini Mart Inc
LET 2 Office of Tobacco Progams (HF-11) Vol#: 1
98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding;
C 122 Ronald W. Reinhart Vol#: 19
98N-0405 Preamendments Class III Devices
NFR 1 Vol#: 1
98N-0467 Class III Preamendments Physical Medicine Devices
NFR 1 Vol#: 1
98N-0728 Mammography Standards
NFR 1 Vol#: 1
98N-1038 Irradiation in the production, processing, &handling of food
C 638 Form letters 67 Vol#: 13
C 640 Chrishia H. Rodriquez Vol#: 12
C 641 Claire B. Feder Vol#: 12
C 642 Floyd D. Herman Vol#: 12
C 643 Robin M. Hessey Vol#: 14
C 644 Jeanne Woytkowink Vol#: 14
C 646 Erin Kelly-Dill Vol#: 14
C 648 Mary E. Anderson Vol#: 14
C 650 Elizabeth C. Parker Vol#: 14
C 653 Valaree Hemighaus Vol#: 14
C 654 Patrice Mcllravy Vol#: 14
98N-1109 Mercury Compounds in Drugs and Food
98N-1265 Distribution of Compounded Drug Products
C 1079 Velma J. Rothe Vol#: 58
C 1082 Rachel F. Dowdy Vol#: 58
C 1089 Patricia Doyle-Grace Vol#: 58
C 1092 Jodie L. Adams Vol#: 58
C 1093 L. A. Dee Shibling Vol#: 58
C 1094 Shawn L. Seward Vol#: 58
C 1095 Shirley H. DaSilva Vol#: 58
C 1096 Roberta Griffiths Vol#: 58
C 1098 Dennis L. David Vol#: 58
C 1100 Susan M. Lussier Vol#: 58
C 1101 Roy W. Anderson Vol#: 58
C 1102 Vern & Pearl Ketz Vol#: 58
C 1103 Frances M. Leo Vol#: 58
C 1104 Janey S. McCauley Vol#: 58
C 1105 Gerard Bernardi Vol#: 58
C 1109 Maureen Jividen Vol#: 58
C 1112 Barbara D. Malecki Vol#: 58
C 1113 Molly A. McClure Vol#: 58
C 1114 Carol A. Zimmerman Vol#: 58
C 1115 Lynda Dutzmann Vol#: 58
C 1117 Joanne L. Donnelly Vol#: 58
C 1118 Linda Sullivan Vol#: 58
C 1120 Patricia Jensen Vol#: 58
98P-0151 Introduction Of Downed Cattle Into The Food Supply
C 2080 Nicole J. Goodreau Vol#: 52
C 2081 Lisa S. Butler Vol#: 52
98P-0504 Raw Molluscan Shellfish of Undetectable Levels
C 25 Chabill's tire Service, Inc. Vol#: 1
C 26 Herrold Fish & Oyster Co., Inc. Vol#: 1
C 27 P & J Oyster Co., Inc. Vol#: 1
C 28 W. H. Harris Seafood, Inc. Vol#: 1
C 29 Sunrise Cove Trading Co., Inc. Vol#: 1
98P-1121 Grated Parmesan Cheese Deviating from Identity standard
BKG 1 Kraft Foods Inc Vol#: 1
98P-1194 Withdrawal NADA Approval for Posilac - rBGH
C 85 Demeter Assn., Inc. Vol#: 3
99D-0121 Waiver of in vivo biavailability & bioequivalence studies
99F-0187 Neotame - Filing of Food Additive Petition (FAP 9A4643)
99H-0091 Civil Money Penalties;Mark S Thornton,d/b/a J & M Stop & Go
LET 2 Office of Tobacco Progams (HF-11) Vol#: 1
99H-0092 Civil Money Penalties;Tip Top Convenience Store Inc,d/b/a
LET 2 Office of Tobacco Progams (HF-11) Vol#: 1
99H-0578 Civil Money Penalties;Sinclair Oil Corp,d/b/a Sinclair
ANS 1 Sinclair Oil Corp Vol#: 1
99H-0700 Civil Money Penalties;Robert Burke,d/b/a Burke's Uptown Mark
ANS 1 Burke's Uptown Market Vol#: 1