FDA - Food and Drug Administration

DOCKETS ENTERED on APRIL 19, 1999

Updated as of 6:45 am, April 23, 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-0065 Skin Bleaching Drug Products
78N-021D Skin Protectant Drug Proposed Rulemaking for Diaper Rash
94S-0120 510K Substantially Equivalent List
98D-0777 Investigating out of Specification(OOS)Test Results fr Pharm
98D-0785 Medical imaging drugs and biologics
98D-0994 Draft Guidance for Industry on BACPAC I
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa
98D-1195 Bioanalytical Methods Validation for Human Studies
98N-1038 Irradiation in the production, processing, &handling of food
98N-1265 Distribution of Compounded Drug Products
98P-0504 Raw Molluscan Shellfish of Undetectable Levels
99N-0386 Talking with Stakeholders About FDA Modernization
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

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78N-0065 Skin Bleaching Drug Products

C 24 Consumer Healthcare Products Assn Vol#: 4

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78N-021D Skin Protectant Drug Proposed Rulemaking for Diaper Rash

MM 4 HFD-560 & Flanders, Inc. Vol#: 7

90P-0201 Optimum size & Style of print to be used to label OTC Drugs

NCR 1 Vol#: 7

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94S-0120 510K Substantially Equivalent List

LST 82 March 1999 Vol#: 20

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95N-0259 Over the Counter Drug Labeling; Public Hearing

NCR 2 Vol#: 11

96N-0420 OTC Human Drugs; Proposed Labeling Requirements

NCR 1 Vol#: 23

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98D-0777 Investigating out of Specification(OOS)Test Results fr Pharm

C 37 John W. Rohrer Vol#: 2

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98D-0785 Medical imaging drugs and biologics

C 15 Advanced Magnetics, Inc. Vol#: 2

C 16 Bracco Diagnostics, Inc. Vol#: 2

C 17 Nycomed Amersham Imaging Vol#: 2

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98D-0994 Draft Guidance for Industry on BACPAC I

C 31 Bristol-Myers Squibb Vol#: 2

C 32 Merck KGaA Vol#: 2

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98D-1146 Microbial effects of antimicrobial new animal drugs/human sa

C 46 Jocelyn Diakon Vol#: 2

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98D-1195 Bioanalytical Methods Validation for Human Studies

C 34 Bristol-Myers Squibb Vol#: 2

98N-0337 Over the counter human drugs labeling requirements

NCR 1 Vol#: 1

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

C 656 Patricia Keane Vol#: 14

C 657 Astara Knowley Vol#: 14

C 658 Chris Grear Vol#: 14

C 659 Clifford J. Baker Vol#: 14

C 660 Anne Paxton Vol#: 14

C 661 Daniel W.E. Holt Vol#: 14

C 662 Kyle Thorson Vol#: 14

C 663 Lauren Smith Vol#: 14

C 664 Barbara King Vol#: 14

C 665 Global Resource Action Ctr for the Envir Vol#: 14

C 666 Donna M. & Karl Jaricek Vol#: 14

C 667 John A. Watson Vol#: 14

C 668 Eric Weiner Vol#: 14

C 669 Katherine Halkedis Vol#: 14

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98N-1265 Distribution of Compounded Drug Products

C 1155 Honou M. Rocker Vol#: 69

C 1156 Jeanie Franco Marx Vol#: 69

C 1157 Walter Schwartz Vol#: 69

C 1158 George Lichter Vol#: 69

C 1159 Cynthia L. Sher Vol#: 69

C 1160 Barbara J. Feddeiser Vol#: 69

C 1161 Pamela R. Hoy Vol#: 69

C 1162 Cynthia A. Smith Vol#: 69

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98P-0504 Raw Molluscan Shellfish of Undetectable Levels

C 32 Marie's Auto Parts Store No. 2, Inc. Vol#: 1

C 33 Pearl of Alaska Vol#: 1

C 34 Ocean State Aquaculture Assn. Vol#: 1

C 35 Westcott Bay Sea Farms Vol#: 1

C 36 James A. Comiskey Vol#: 1

C 37 Capt. Frank's Oysters Vol#: 1

C 38 Peter W. Frank Vol#: 1

C 39 Goff's Quality Foods, Inc. Vol#: 1

C 40 Johnny's Oyster & Shrimp, Inc. Vol#: 1

C 41 Pickering Pass Oyster Farm Vol#: 1

C 42 Scowbat Oyster Farm Vol#: 1

C 43 Industrial Metals of the South, Inc. Vol#: 1

C 44 Herrold Fish & Oyster Co., Inc. Vol#: 1

C 45 Herrold Fish & Oyster Co., Inc. Vol#: 1

C 46 Herrold Fish & Oyster Co., Inc. Vol#: 1

C 47 Southeastern Fisheries Assn, Inc. Vol#: 1

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99H-0442 Civil Money Penalties;Fred D Duell,d/b/a One Stop

CS 1 HFA-305 Vol#: 1

MO 1 Fred D Duell,d/b/a One Stop Vol#: 1

OR 1 HF-3 Vol#: 1

99H-0482 Civil Money Penalties;Larry Parker,d/b/a J & L Convenience

ANS 1 J & L Convenience Vol#: 1

99H-0873 Civil Money Penalties;Food Lion Inc,d/b/a Food Lion Store

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0874 Civil Money Penalties;Food Lion Inc,d/b/a Food Lion Store

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0875 Civil Money Penalties;Dalee Oil Co,d/b/a One Stop #4

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0876 Civil Money Penalties;Savway Inc,d/b/a Savway #10

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0877 Civil Money Penalties;B & M Lee Oil Co Inc,d/b/a Fast Shop

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0878 Civil Money Penalties; Dell Oil Ltd,d/b/a Dell Oil

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0879 Civil Money Penalties;K C Mart Inc,d/b/a Stuart 66 Truck Stp

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0880 Civil Money Penalties;MFA Oil Co,d/b/a Break Time

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0881 Civil Money Penalties;B & L Food Stores Inc,d/b/a B & L Appl

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0882 Civil Money Penalties;Shop N Save Mass.Inc,d/b/a Shop N Save

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0883 Civil Money Penalties;Reinhart Bros Inc,d/b/a Jubilee Foods

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0884 Civil Money Penalties;Li'L Thrift Food Marts Inc,d/b/a Short

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0885 Civil Money Penalties;Russ's Beer & Bottle Inc,d/b/a Russ's

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0886 Civil Money Penalties;Minit Food Mart Inc,d/b/a Minit Food

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0887 Civil Money Penalties;Town & Country Grocers of Fredericktow

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0888 Civil Money Penalties;Landmark Liquors Inc,d/b/a Landmark

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0889 Civil Money Penalties;Rodney W Ray,d/ba/ Rod's Convenience

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0890 Civil Money Penalties;Marc K Quinn,d/b/a Marc's Variety

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0891 Civil Money Penalties;Virgil Johnson,d/b/a Johnson One Stop

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0892 Civil Money Penalties;Sibi Kadalimattam,d/b/a Maywood Mart

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0898 Civil Money Penalty; Berry-Hinckley Industries d/b/a Winner'

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0899 Civil Money Penalty; Gary Conley d/b/a Conley's Service Stat

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0900 Civil Money Penalty; Cooper-Page Inc d/b/a Hunters Exxon

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0901 Civil Money Penalty; Cumberland Farms Inc d/b/a Cumberland

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99N-0188 Progestational Drug Products for Human Use

BKG 1 Vol#: 1

NPR 1 Vol#: 1

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99N-0386 Talking with Stakeholders About FDA Modernization

C 4 National Aquaculture Association Vol#: 1

C 5 Robert & Mary Gadbois Vol#: 1

C 6 Paul G King Consulting Vol#: 1

99N-0671 Manufacture of Whole Blood and Red Blood Cells

NPH 1 Vol#: 1

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99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 6 George H. Estes Vol#: 1

C 7 Libley Nuidera Vol#: 1

C 8 B. K. & Janice Jensen Vol#: 1

C 9 Mark M. Giese Vol#: 1

C 10 Mary Lou Cohen Vol#: 1

C 11 Toni L. Goldfarb Vol#: 1

C 12 Diane Alexy Vol#: 1

C 13 Margaret S. D'Agnessa Vol#: 1

C 14 Kathy Winkler Vol#: 1

C 15 Thelma D. Cabaniss Vol#: 1

C 16 Mary Whiteman Vol#: 1

C 17 Patricia Cachopo Vol#: 1

C 18 Letitia O. Principato Vol#: 1

C 19 Mary Millemaci Vol#: 1

C 20 Ruth Sloman Vol#: 1

C 21 Barbara Keenan Vol#: 1

C 22 Mrs. Ruth Morrice Vol#: 1

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