Updated as of 11:00 am, April 27, 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.
 

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77N-0240 Single-Entity Coronary Vasodilators

HER 36 Schwarz Pharma, Inc. Vol#: 27

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77N-0420 REINSTATEMENT ANIMAL DRUG APPLICATIONS

LET 30 HFA-305 Vol#: 27

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78N-0038 Sunscreen Drug Products

EXT 8 The Procter & Gamble Company Vol#: 111

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80N-0042 Anticaries Drug Products for OTC Human Use

RPT 8 Mr. Robert Sherman Vol#: 31

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80N-0295 OTC drug review policy statement

MM 112 HFD-560 & Playtex Products, Inc Vol#: 3

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92N-0139 Statement Policy: Foods Derived from New Plant Varieties

C 5018 Cindy Berger Vol#: 78

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96G-0264 Konjac flour be affirmed as GRAS for use as food ingredient

EA 1 HFS-205 Vol#: 1

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98D-0994 Draft Guidance for Industry on BACPAC I

C 35 Basf Pharma Knoll AG Vol#: 2

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

C 47 Petra Godwin Vol#: 2

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98D-1267 Impurities in Drug Substances

C 6 The R. W. Johnson Pharm Research Inst Vol#: 1

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98N-0970 Labeling for Menstrual Tampons

C 3 Association of Nonwoven Fabrics Industry Vol#: 1

C 4 Playtex Products, Inc Vol#: 1

C 5 Procter & Gamble Vol#: 1

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

C 715 Daniel McGowan Vol#: 14

C 716 Julie Lampky Vol#: 14

C 717 Gail Fuhrer Vol#: 14

C 718 Billii (Helen M.) Roberti Vol#: 14

C 719 Sandra V, Mueller Vol#: 14

C 720 Ctr for Occupational & Environmental Med Vol#: 14

C 721 Brian Lamorcarx Vol#: 16

C 722 Abigail Barden Vol#: 16

C 723 Karen Wesolowski Vol#: 16

C 724 Marjorie Wesolowski et al Vol#: 16

C 725 Karen Lovelien Vol#: 16

C 726 Keith Hiestand Vol#: 16

C 727 Elizabeth Hands Vol#: 16

C 728 Cynthea Paul Vol#: 16

C 729 Joyce B. Soule Vol#: 16

C 730 Natural Foods Cooperative Vol#: 16

C 731 Peggy Clark Lumpkins Vol#: 16

C 732 Noah Forrest Vol#: 16

C 733 Carol A. Zitani Vol#: 16

C 734 Jill Hamze Vol#: 16

C 735 S. Goodspeed Vol#: 16

C 736 Leslie McConnell & Edward Bridge-Koenigs Vol#: 16

C 737 Judy A. Wyman Vol#: 16

C 738 Jackson Gillman Vol#: 16

C 739 Friends of Hamakua Vol#: 16

C 740 Julienne Stroeve Vol#: 16

C 741 Form Letters 8 Vol#: 17

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98N-1265 Distribution of Compounded Drug Products

C 1247 Maxine Coah Vol#: 71

C 1248 Judy A. Harris Vol#: 71

C 1249 Karen Keith Vol#: 71

C 1250 Anita Hoffman Vol#: 71

C 1251 Mrs. Rosa Connell Vol#: 71

C 1252 Velvet George Ellen O'Sullivan Vol#: 71

C 1253 Diane Kelly Vol#: 71

C 1254 Judith Charles Vol#: 71

C 1255 Jeannette Allan Vol#: 71

C 1256 Carol Loitfellner Vol#: 71

C 1257 Tracy Napoli Vol#: 71

C 1258 Neva & Larry Bailey Vol#: 71

C 1259 Sylvia C. Asbury Vol#: 71

C 1260 Karye Wilnen Vol#: 71

C 1261 S. H. Utter Vol#: 71

C 1262 Josephine La Forgia Vol#: 71

C 1263 Carol R. Plochman Vol#: 71

C 1264 Barbara Sloan Vol#: 71

C 1265 Karen M. Wasolowski Vol#: 71

C 1266 Suzanne Dalton Vol#: 71

C 1267 Rose Litton Vol#: 71

C 1268 David L. Newman Vol#: 71

C 1269 Karen Henriksen Vol#: 71

C 1270 Carolyn D. Chapin Vol#: 71

C 1271 Susan Byron Vol#: 71

C 1272 Rebecca Shefchek Vol#: 71

C 1273 R. N. Davis Vol#: 71

C 1274 Constance Winstead Vol#: 71

C 1275 Richard & Linda Nathan Vol#: 71

C 1276 Elizabeth Hester Vol#: 71

C 1277 Ray's Pharmacy Vol#: 71

C 1278 Mary Lou Wilhelm Vol#: 71

C 1279 Hazel Daren Vol#: 71

C 1280 Jan Paulins Vol#: 71

C 1281 Mary-Ellen Herbert Vol#: 71

C 1282 Carrie Lewis Vol#: 71

C 1283 Mary Lou Chin Vol#: 71

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

C 2091 Jennifer C. Sarkisian Vol#: 52

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98P-0504 Raw Molluscan Shellfish of Undetectable Levels

C 76 ISSC, Interstate Shellfish Sanitation Co Vol#: 8

C 77 0tephen Hassinger Vol#: 8

C 78 Francisco Fonseca Vol#: 8

C 79 Maurice River Oyster Culture Foundation, Vol#: 8

C 80 Louisiana State University Vol#: 8

C 81 Louis Polster Vol#: 8

C 82 Manuel Reyes et al Vol#: 8

C 83 J & S Oyster Corp. Vol#: 8

C 84 Joanne McCall Magness Vol#: 8

C 85 Louisiana Oysters Pearls of Health Vol#: 8

C 86 City of Houma Parish of Terrebonne Vol#: 8

C 87 Mississippi Restaurant Assn. Resolution Vol#: 8

C 88 Efram Naquin Vol#: 8

C 89 Lynn's Quality Oysters, Inc. Vol#: 8

C 90 Nicks Seafood Vol#: 12

C 91 Jurisich Oysters Vol#: 12

C 92 Jurisich Oysters Vol#: 12

C 93 Jurisich Oysters Vol#: 12

C 94 NJAA, New Jersey Aquaculture Assn. Vol#: 12

C 95 Congress of the United States Vol#: 12

C 96 Middle Peninsula Aquaculture Vol#: 12

C 97 Pacific Coast Oyster Growers Assn. Vol#: 12

C 98 Margaret H. Fraser Vol#: 12

C 99 Robert J. Sund Vol#: 12

C 100 Moore Oysters Vol#: 12

C 101 J. W. Blume, Inc. Vol#: 12

C 102 Great East Mussel Farms Inc. Vol#: 12

C 103 Leavins Seafood, Inc. Vol#: 12

C 104 Pak West Paper & Chemical Vol#: 12

C 105 Paul Russell Vol#: 12

C 106 Northeast Shellfish Growers & Dealers Vol#: 12

C 107 Security State Bank Vol#: 12

C 108 Water Front Seafood Fresh Crabmeat Vol#: 12

C 109 Restaurant Assn. of Maryland Vol#: 12

C 110 Virginia Seafood Council Vol#: 12

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98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 86 Catherine Ralston Vol#: 3

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

C 9 Pfizer Inc Vol#: 1

C 10 Wyeth-Ayerst Research Vol#: 1

99D-0674 Investigational new drug applications for phase 2&3 of drugs

GDL 1 (HFD-810) and (HFM-10) Vol#: 1

NAD 1 Vol#: 1

99H-0077 Civil Money Penalties; Honey Farms Inc.

LET 2 Office of Tobacco Programs Vol#: 1

99H-0959 Civil Money Penalties;McGovern Reality Trust,d/b/a Salem Sun

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

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

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0974 Civil Money Penalties;George Knight & Jackie Knight,d/b/a

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0975 Civil Money Penalties;George Mantas,d/b/a Roslindale Texaco

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0976 Civil Money Penalties;Rajiv Karua,d/b/a Kaka Food Mart

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0977 Civil Money Penalties;Gwen Moore,d/b/a Grocery Basket #2

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0978 Civil Money Penalties;Childers Oil Co,d/b/a Hindman Double

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0979 Civil Money Penalties;Melvin Brodofsky,d/b/a Melvin's One

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0980 Civil Money Penalties;Chiu Hung Chow,d/b/a Tai Hong Restaura

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0981 Civil Money Penalties;Gene F Yeang,d/b/a David's Food Center

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0982 Civil Money Penalties;Kazimir Ent Inc,d/b/a One Stop Liquor

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0983 Civil Money Penalties;Kmart Corp,d/b/a Kmart Store #3310

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0984 Civil Money Penalties;Pantry Markets Ltd,d/b/a The Pantry

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0985 Civil Money Penalties;Wal-Mart Stores Inc,d/b/a Wal-Mart

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0986 Civil Money Penalties;Charles Harrington,d/b/a 7-Eleven

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0987 Civil Money Penalties;Gulzar Kular,d/b/a 7-Eleven

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0988 Civil Money Penalties;Street Ent Inc,d/b/a Mall Exxon

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0989 Civil Money Penalties;Ultramar Diamond Shamrock Corp,d/b/a

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0990 Civil Money Penalties;Jitney Jungle Stores of America,d/b/a

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0991 Civil Money Penalties;Sandra Langham,d/b/a A & J's Mini Mart

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0992 Civil Money Penalties;Lee's Inc,d/b/a Dolly's Quick Stop

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0993 Civil Money Penalties;Double Quick Inc,d/b/a Double Quick 53

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

NPH 1 HHS/FDA/CDER Vol#: 1

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99N-0386 Talking with Stakeholders About FDA Modernization

C 7 Jean H Townsend Vol#: 1

EC 3 CA Health & Human Services, Dept of Hlth Vol#: 1

EC 4 Campbell Assoc. Vol#: 1

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99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 46 Gloria Mack Vol#: 1

C 47 Ingelore Goetz Vol#: 1

C 48 Sheldon Hearst Vol#: 1

C 49 M. Rich Vol#: 1

C 50 Nancy Sailor Vol#: 1

C 51 Rolland & Jan Grote Vol#: 1

C 52 Mr & Mrs Albert Adams Vol#: 1

C 53 Mr & Mrs A. Cooper Vol#: 1

C 54 Suzanna Hermans Vol#: 1

C 55 Mrs. Dorothy C. Ramsaier Vol#: 1

C 56 Norma B. Hamilton Vol#: 1

C 57 Mrs. Delagado Vol#: 1

C 58 Mr. Douglas E. Morris Vol#: 1

C 59 Mr. & Mrs. Edgar N. Brown Vol#: 1

C 60 Ms. B. Santhoff Vol#: 1

C 61 Helen G. Strzalka Vol#: 1

C 62 Lola M. Hudson Vol#: 1

C 63 Margaret J. Sarna Vol#: 1

C 64 Margaret Gebhard Vol#: 1

C 65 Paul & Eileen LeFort Vol#: 1

C 66 M. McGinnis Vol#: 1

C 67 Helen L. Thompson Vol#: 1

C 68 Mrs. Dorothea J. S. Goetz Vol#: 1

C 69 Illegible Vol#: 1

C 70 Wyvone Harris Vol#: 1

C 71 Anna L. Moretto Vol#: 1

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99V-1072 Laser Fantasy International: 1-Rainbow 1 projector & 2-11000

VAR 1 Athelets in Action Vol#: 1

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