DOCKETS ENTERED on APRIL 20, 1999

Updated as of 9:30 am, April 26, 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-0085 Saccharin and Its Salts

CA 27185 J O Carlson Vol#: 426

CA 27186 J F Thompson Vol#: 426

CA 27187 J M Cost Vol#: 426

CA 27188 G Wasser Vol#: 426

CA 27189 J Johnson Vol#: 426

CA 27190 J L Dodd Vol#: 426

CA 27191 D D Clayton Vol#: 426

CA 27192 P Casto Vol#: 426

CA 27193 F A Kelly, M.D. Vol#: 426

CA 27194 H K Critz Vol#: 426

CA 27195 A Fazio Vol#: 426

CA 27196 B Headlee Vol#: 426

CA 27197 T L Langley Vol#: 426

CA 27198 G Markie Vol#: 426

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77N-0240 Single-Entity Coronary Vasodilators

NPH 7 Vol#: 27

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80N-0042 Anticaries Drug Products for OTC Human Use

SUP 10 The Cosmetic, Toiletry & Fragrance Assn Vol#: 31

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

C 5012 June Kluglein Vol#: 78

C 5013 Rita Solow Vol#: 78

C 5014 Lori Csigay Vol#: 78

C 5015 Susan C. Jesson Vol#: 78

C 5016 Karl Bernhard Vol#: 78

C 5017 Kathy Harris Vol#: 78

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95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability

C 3688 Honorable Tom Harkin (CI) Vol#: 291

C 3689 Honorable Joseph R. Pitts (CI) Vol#: 291

C 3690 Honorable Orrin H. Hatch (CI) Vol#: 291

C 3691 Honorable Rick Santorum (CI) Vol#: 291

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95S-0316 75-Day Premarket Notifications for New Dietary Ingredients

RPT 40 General Nutrition Corporation Vol#: 21

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97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)

LET 263 HFS-456 to Herbalife International of Am Vol#: 5

LET 264 HFS-456 to Rexall-Sundown Vol#: 5

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98D-1267 Impurities in Drug Substances

C 3 Catalytica Pharmaceuticals Vol#: 1

C 4 Eli Lilly & Company Vol#: 1

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98N-0044 Effect of dietary supplement on structure/function of body

C 22304 Lila & Irwin Berman Vol#: 771

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98N-0979 Investigational New Drug Applications; Clinical Holds

NCD 1 Vol#: 1

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

C 670 SaferFoods Corp. Vol#: 14

C 671 Barbara Ward Vol#: 14

C 672 Don Ogden Vol#: 14

C 673 Jay Stryker Vol#: 14

C 674 Jeff Henderson Vol#: 14

C 675 Mrs. Doris Endy Vol#: 14

C 676 Mildred K. Bonesen Vol#: 14

C 677 Brian Cady Vol#: 14

C 678 Demian R. Potter Vol#: 14

C 679 Wini Noyes Vol#: 14

C 680 Ralph C. Bailey Vol#: 14

C 681 Karen Eipel Vol#: 14

C 682 Fayette Fox Vol#: 14

C 683 Margaret B. Wood Vol#: 14

C 684 Alyce M. Engestrom Vol#: 14

C 685 Joan Schmitz Vol#: 14

C 686 Dorothy Mclver Vol#: 14

C 687 W.K. Hudson Vol#: 14

C 688 James E. Briones Vol#: 14

C 689 Leslie Duram Vol#: 14

C 690 Sylvia Blanchet Vol#: 14

C 691 Fmthestars Vol#: 14

C 692 M. Lindsey Vol#: 14

C 693 Marci A. Hennigh, RPh Vol#: 14

C 694 Shirley & Bobbie McKibbin Vol#: 14

C 695 Janet Venable Vol#: 14

C 696 B. McDonald Vol#: 14

C 697 Michael Blate Vol#: 14

C 698 B.K. Barnett Vol#: 14

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98N-1110 CGMP Regulations for Finished Pharmaceuticals

N 2 Vol#: 1

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98N-1265 Distribution of Compounded Drug Products

C 1163 Todd Courtney Vol#: 69

C 1164 Laura A. McGeehon Vol#: 69

C 1165 Ethel Rokloff Vol#: 69

C 1166 Melissa Connelly Vol#: 69

C 1167 Susan J. Brown Vol#: 69

C 1168 Pippin Warfield-Hine Vol#: 69

C 1169 Philip D. Ranheim, MD Vol#: 69

C 1170 Susan L. Feldman Vol#: 69

C 1171 B. Dawn Tepperman, Ph.D Vol#: 69

C 1172 Cheryl Horrall Vol#: 69

C 1173 Elena M. Brase Vol#: 69

C 1174 Linda L. Trammell Vol#: 69

C 1175 Linda C. Ball Vol#: 69

C 1176 Elizabeth C. Lange Vol#: 69

C 1177 Candice Carsen Vol#: 69

C 1178 Joyce Jennis Vol#: 69

C 1179 Hope L. Miller Vol#: 69

C 1180 Barbara E. Sherman Vol#: 69

C 1181 Sheilah Judah Vol#: 69

C 1182 Nancy C. Froio Vol#: 69

C 1183 Sherry Davis Vol#: 69

C 1184 Deane W. Parks Vol#: 69

C 1185 Karen A. Broman Vol#: 69

C 1186 Martha Fryley Vol#: 69

C 1187 Judi M. Small Vol#: 69

C 1188 Roes Hoaas Vol#: 69

C 1189 Judy Shirley Vol#: 69

C 1190 Arlene Billups Vol#: 69

C 1191 Doug & Katie Steele Vol#: 69

C 1192 Heidi Young Vol#: 69

C 1193 Alberta H. Ardapple Vol#: 69

C 1194 Jeffrey J. Argentos Vol#: 69

C 1195 Kimberlee Allen Vol#: 69

C 1196 Gerald Rairigh Vol#: 69

C 1197 Paula Wolk Vol#: 69

C 1198 Lauran E. Findlay Vol#: 69

C 1199 Jeanette Beisner Vol#: 69

C 1200 Barbara A. Grove Vol#: 69

C 1201 Patricia Napier Vol#: 69

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

C 2084 Lisa M. Gerber Vol#: 52

C 2085 Christine Hadley Vol#: 52

C 2086 Jason & Susan Brock Vol#: 52

C 2087 Lisa A. Pollione Vol#: 52

C 2088 Virginia Baisley Vol#: 52

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98P-0203 Eliminate Forced Molting of Laying Birds

C 979 Linda Reynolds Vol#: 24

C 980 Patricia A Sawyer Vol#: 24

C 981 Mr Bobby Johnson Vol#: 24

C 982 Doug Gemmell Vol#: 24

C 983 George H Estes Vol#: 24

C 984 Marikay D Gruen Vol#: 24

C 985 Randall G Erdley & Barbara I Erdley Vol#: 24

C 986 Erin J Marcus & Judy Marcus Vol#: 24

C 987 Gregory Edward Koch Vol#: 24

C 988 Ms Joan Kuveke Vol#:

C 989 David T or Diane C Olszewski Vol#: 24

C 990 Faye Nielsen Vol#: 24

C 991 Nancy Loewen Vol#: 24

C 992 Joseph D Lamping Vol#: 24

C 993 Diane Dash Vol#: 24

C 994 Deborah Donofrio Vol#: 24

C 995 Dawn Case Vol#: 24

C 996 Jessica Waknine et al Vol#: 24

C 997 Janet Eisberner Vol#: 24

C 998 The Boyd Family Vol#: 24

C 999 Ken Belsley Vol#: 24

C 1000 Joyce Akakelian Vol#: 24

C 1001 Al & Zoe Nierenberg Vol#: 24

C 1002 Catherine Dishion Vol#: 25

C 1003 M Peppercorn MD Vol#: 24

C 1004 Erik Sander Vol#: 24

C 1005 Krist L Heaton & Elizabeth A Heelan Vol#: 24

C 1006 Diane Riel Vol#: 25

C 1007 Diane Riel Vol#: 25

C 1008 R Soto Vol#: 25

C 1009 Ms Sara Chenoweth Vol#: 25

C 1010 Elizabeth Sterenberg Shulman PHD Vol#: 25

C 1011 Jori L Church Vol#: 25

C 1012 Krista Fowler Vol#: 25

C 1013 Ms Robin R Einbund Vol#: 25

C 1014 Ms Christine Ostopoff Vol#: 25

C 1015 Ms Irene Hart Vol#: 25

C 1016 John & Deborah Haynes Vol#: 25

C 1017 Lagretta Nelson Vol#: 25

C 1018 Ms Jamie Himmelstein Vol#: 25

C 1019 Ms Bridget Gail Webb Vol#: 25

C 1020 Rachel S van Hest Vol#: 25

C 1021 Ms Marilyn Evenson Vol#: 25

C 1022 Merry Thompson Vol#: 25

C 1023 V Barnatt Vol#: 25

C 1024 Mrs Linda Strohm Vol#: 25

C 1025 Sallie Carlson & Family Vol#: 25

C 1026 Ryan Adcock Vol#: 25

C 1027 Edward & Maurine Mihalek Vol#: 25

C 1028 Tobin Williams Vol#: 25

C 1029 Anne Robinson Vol#: 25

C 1030 Jene Heatherbee Vol#: 25

C 1031 Fran Denowitz Vol#: 25

C 1032 Sarah L Feit Vol#: 25

C 1033 Michele Boderck Vol#: 25

C 1034 Cindy Miller Vol#: 25

C 1035 Rochelle Font-Ferne Vol#: 25

C 1036 Sharyn Winters Vol#: 25

C 1037 D Calabrese Vol#: 25

C 1038 Mr & Mrs W Huenke Vol#: 25

C 1039 Ms Lilliand Simon Vol#: 25

C 1040 Mary Nelson Vol#: 25

C 1041 Catalina Kidd Vol#: 25

C 1042 Gertrude & Robert Buccelly Vol#: 25

C 1043 Ms Merriam T Karlin Vol#: 25

C 1044 Joanna Lucas Vol#: 25

C 1045 Susan Papertsian Vol#: 25

C 1046 C Birgham Vol#: 25

C 1047 Ernesto & Edith C Parrao Vol#:

C 1048 Ms Johanne Rionx Vol#: 25

C 1049 Crazy Monkey Vol#: 25

C 1050 Christine Jeschke Vol#: 25

C 1051 Ms Lauren Jarae Vol#: 25

C 1052 Candy Knippenberg Vol#: 25

C 1053 Roberta Claypool Vol#: 25

C 1054 Joan Bennett Vol#: 25

C 1055 Deede Dritsopoulos Vol#: 25

C 1056 Patricia Kiltzke Vol#: 25

C 1057 Karen Walker Vol#: 25

C 1058 Jennifer G Buchanan Vol#: 25

C 1059 R Sloman Vol#: 25

C 1060 Mr Ed Russo Vol#: 25

C 1061 B K & Janice Jensen Vol#: 25

C 1062 Barbara Keenan Vol#: 25

C 1063 Mrs Woody G Lambert Vol#: 25

C 1064 Rodney Hood & Carolyn Vol#: 25

C 1065 Betty C Miles Vol#: 25

C 1066 Paula Bulllinger Vol#: 25

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98P-0504 Raw Molluscan Shellfish of Undetectable Levels

C 48 Jeri's Seafood, Inc. Vol#: 1

C 49 Sysco Food Services - Jacksonville, Inc. Vol#: 1

C 50 Ace Auto Paint Vol#: 1

C 51 Captain Salty's Seafood, Inc. Vol#: 1

C 52 Intertidal Aquafarms, Inc. Vol#: 1

C 53 Bay Center Mariculture Co. Vol#: 1

C 54 Northern Oyster Co. Vol#: 1

C 55 CFA, Consumer Federation of America Vol#: 1

C 56 Valley Foodservice Vol#: 1

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99F-0804 Filing of Food Additive Petition (FAP 9B4645)

NFL 1 Rohm and Haas Co. Vol#: 1

99H-0902 Civil Money Penalty;CVS Revco DS Inc d/b/a CVS Pharmacy 6327

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0903 Civil Money Penalty;Emmick Oil Inc d/b/a Jumpin Jacks Food M

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0904 Civil Money Penalty; Hood Petroleum Co Inc d/b/a 27-55 Gas P

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0905 Civil Money Penalty; Kmart Corp d/b/a Kmart #4864

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0906 Civil Money Penalty;Sunny Poma d/b/a Fireside Mini Mart & Li

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0907 Civil Money Penalty;Robert Ramirez d/b/a King's Food & Gas

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0908 Civil Money Penalty;Rosser Grocery Co d/b/a Jerry's IGA

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0909 Civil Money Penalty; Safeway Stores Inc d/b/a Safeway #330

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0910 Civil Money Penalty; Sayle Oil Co Inc d/b/a Marks Gas Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0911 Civil Money Penalty; Southwest Convenience Stores LLC d/b/a

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0912 Civil Money Penalty; Spaceway Oil Co Inc d/b/a Spaceway Oil

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0913 Civil Money Penalty; Daniel M Sparks d/b/a Incline Village S

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0914 Civil Money Penalty; Southland Corp d/b/a 7-Eleven #18497

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0915 Civil Money Penalty; Thomas Investments Inc d/b/a Shell Food

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0917 Civil Money Penalty; Ultramar Diamond Shamrock Corp d/b/a Di

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0918 Civil Money Penalty; Gurjit Uppal & Manginder Signh d/b/a Ar

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0919 Civil Money Penalty; Vettese Inc d/b/a Venient Food Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0920 Civil Money Penalty; Vinaco Inc d/b/a Sunrise Gas & Food

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0921 Civil Money Penalty; Southland Corp. d/b/a 7-Eleven #20237

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0927 Civil Money Penalties;Trade Oil Co,d/b/a Trade Mart #52

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0928 Civil Money Penalties;Norrenberns Foods Inc,d/b/a Cash Saver

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0929 Civil Money Penalties;Lanctots Grocers Inc,d/b/a Lanctots

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0930 Civil Money Penalties;L & J's Country Store Inc,d/b/a L & J

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0931 Civil Money Penalties;Pettit of Brainerd Inc,d/b/a Tom Thumb

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0932 Civil Money Penalties; La Salle Farmers Grain Co,d/b/a

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0933 Civil Money Penalties;Midland Oil Co,d/b/a Deer Park Store

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0934 Civil Money Penalties;Holiday Stationstores Inc,d/b/a Holida

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0935 Civil Money Penalties;No. Am Inc,d/b/a Holiday Station Store

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0936 Civil Money Penalties;Marohn's Annandale Marketplace Inc,d/b

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0937 Civil Money Penalties;Adventure Ent Inc,d/b/a South Haven

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0938 Civil Money Penalties;Dahir Brothers Inc,d/b/a Triangle

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0939 Civil Money Penalties; James R Talley,d/b/a Talley's Conveni

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0940 Civil Money Penalties;Michael Danzinger,d/b/a Dodge's Store

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0941 Civil Money Penalties; John Hawks,d/b/a Kay's Country Store

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0942 Civil Money Penalties;Bob Smith,d/b/a Country Express

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0943 Civil Money Penalties;Mitch Rayl,d/b/a Buffalo Conoco

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0944 Civil Money Penalties;Lester Campbell,d/b/a Cissy's Convenie

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0945 Civil Money Penalties;Austin Underdal,d/b/a Ozark Travel Stp

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0946 Civil Money Penalties;Linda Hannah,d/b/a Hannah's Fast Shop

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

NPH 1 HHS/FDA/CDER Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 23 William C. Ross Vol#: 1

C 24 Tax Payer Illinois Vol#: 1

C 25 Irene Hart Vol#: 1

C 26 Monica D. Maley Vol#: 1

C 27 Joseph Haydt Vol#: 1

C 28 Lydia C. Giglio, Ph.D. Vol#: 1

C 29 Ms. Jill Jakes Vol#: 1

C 30 Celia Newman Vol#: 1

C 31 Lois Gowen Vol#: 1

C 32 Paula Bullinger Vol#: 1

C 33 Mrs. Woody G. Lambert Vol#: 1

C 34 Sharon Flaherty Vol#: 1

C 35 Joseph & Delores Caruana Vol#: 1

C 36 June Vol#: 1

C 37 Carol Smallwood Vol#: 1

C 38 Ms. Marikay Gruen Vol#: 1

C 39 Diane Riel Vol#: 1

C 40 Michael Kulla, Ph.D. Vol#: 1

C 41 John & Deb Haynes Vol#: 1

C 42 Ms. Robin R. Einbund Vol#: 1

C 43 Elaine Holpuch Vol#: 1

C 44 Carol S. Bussoli Vol#: 1

C 45 Diane Obiol Vol#: 1