FDA - Food and Drug Administration

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. 

TABLE OF CONTENTS
(ONLY FOR HYBERLINKED ITEMS)

78N-0038 Sunscreen Drug Products
91N-0281 Effect date for PMA Silicone Inflatable Breast Prosthesis
94F-0405 Safe use of aspartame as general purpose sweetener
96N-0135 Protein Derived from Ruminants Prohibited in Ruminant Feed
98D-0785 Medical imaging drugs and biologics
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa
98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding;
98N-1038 Irradiation in the production, processing, &handling of food
98N-1109 Mercury Compounds in Drugs and 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-1194 Withdrawal NADA Approval for Posilac - rBGH
99D-0121 Waiver of in vivo biavailability & bioequivalence studies
99F-0187 Neotame - Filing of Food Additive Petition (FAP 9A4643)

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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

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78N-0038 Sunscreen Drug Products

ACK 2 HFA-305 Vol#: 111

PSA 1 CTFA Vol#: 111

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

TA 1 Threshold Assessment Vol#: 13

TOP

94F-0405 Safe use of aspartame as general purpose sweetener

C 14 Chester Kapp Vol#: 1

TOP

96N-0135 Protein Derived from Ruminants Prohibited in Ruminant Feed

C 1685 Betty Trentlyon Vol#: 86

C 1686 Ida R. Simpson Vol#: 86

C 1687 Marge Duncan Vol#: 86

C 1688 Maureen B. O. Reilly Vol#: 86

C 1689 Helen Mayhert Vol#: 86

C 1690 Rebekah Paul Vol#: 86

TOP

98D-0785 Medical imaging drugs and biologics

C 13 Council on Radionuclides & Radiopharmace Vol#: 2

C 14 MICAA Vol#: 2

TOP

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

TOP

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

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

C 122 Ronald W. Reinhart Vol#: 19

TOP

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

TOP

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

C 638 Form letters 67 Vol#: 13

C 639 Jon Whitman Vol#: 12

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 645 Mary A. Romine Vol#: 14

C 646 Erin Kelly-Dill Vol#: 14

C 647 Brigitte Diaz Vol#: 14

C 648 Mary E. Anderson Vol#: 14

C 649 Fred Holzweiss Vol#: 14

C 650 Elizabeth C. Parker Vol#: 14

C 651 Isabel Bauer Vol#: 14

C 652 S. Krum Vol#: 14

C 653 Valaree Hemighaus Vol#: 14

C 654 Patrice Mcllravy Vol#: 14

C 655 Estory Vol#: 14

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98N-1109 Mercury Compounds in Drugs and Food

C 1 Eli Lilly & Co. Vol#: 1

TOP

98N-1265 Distribution of Compounded Drug Products

C 1079 Velma J. Rothe Vol#: 58

C 1080 Susan Travers Vol#: 58

C 1081 Dee Simmons Vol#: 58

C 1082 Rachel F. Dowdy Vol#: 58

C 1083 Karen Sutton Vol#: 58

C 1084 Pat Heverok Vol#: 58

C 1085 Judith Cohr Vol#: 58

C 1086 A. Cowler Vol#: 58

C 1087 Karen Luscamb Vol#: 58

C 1088 Zen Seel Vol#: 58

C 1089 Patricia Doyle-Grace Vol#: 58

C 1090 Vera Frazier Vol#: 58

C 1091 Rosalie Barr 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 1097 Carol Davis Vol#: 58

C 1098 Dennis L. David Vol#: 58

C 1099 Peggy Huber 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 1106 Lisa Janson Vol#: 58

C 1107 Sandra Murphy Vol#: 58

C 1108 Mary Castagne Vol#: 58

C 1109 Maureen Jividen Vol#: 58

C 1110 Solange Ruff Vol#: 58

C 1111 Illegible 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 1116 Joanie Wuerth Vol#: 58

C 1117 Joanne L. Donnelly Vol#: 58

C 1118 Linda Sullivan Vol#: 58

C 1119 Sandy Dennis Vol#: 58

C 1120 Patricia Jensen Vol#: 58

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

C 2080 Nicole J. Goodreau Vol#: 52

C 2081 Lisa S. Butler Vol#: 52

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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

TOP

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 85 Demeter Assn., Inc. Vol#: 3

TOP

99D-0121 Waiver of in vivo biavailability & bioequivalence studies

C 2 Bayer Corp. Vol#: 1

TOP

99F-0187 Neotame - Filing of Food Additive Petition (FAP 9A4643)

C 3 NutriVoice Vol#: 1

TOP

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