FDA - Food and Drug Administration

DOCKETS ENTERED on APRIL 14, 1999

Updated as of 11:30 am, April 19, 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)

80N-0295 OTC drug review policy statement
90S-0308 Generic Drug Speeches & Policy and Procedure Guides
93N-0462 Debarment of Abu Quamruzzaman
94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims
98D-0785 Medical imaging drugs and biologics
98N-1038 Irradiation in the production, processing, &handling of food
98N-1265 Distribution of Compounded Drug Products
98P-0203 Eliminate Forced Molting of Laying Birds
99F-0187 Neotame - Filing of Food Additive Petition (FAP 9A4643)
99V-0771 The Laser Tweezer Model Class IIIB

TOP

77N-0085 Saccharin and Its Salts

CA 27054 S Shoemaker Vol#: 424

CA 27055 K Sells Vol#: 424

CA 27056 B Gammell Vol#: 424

CA 27057 A Jones Vol#: 424

CA 27058 D Givens Vol#: 424

CA 27059 P A Gordon Vol#: 424

CA 27060 M Brown Vol#: 424

CA 27061 H P Johnston Vol#: 424

CA 27062 F Skrabanik Vol#: 424

CA 27063 P Washburn Vol#: 424

CA 27064 B Cooper Vol#: 424

CA 27065 G Humphrey Vol#: 424

CA 27066 M Levy Vol#: 424

CA 27067 C B Cross Vol#: 424

CA 27068 E N Shiley Vol#: 424

CA 27069 I Straszkiewicz Vol#: 424

CA 27070 Unsigned Vol#: 424

TOP

80N-0295 OTC drug review policy statement

MM 111 HFD-560 & CHFA et al Vol#: 3

TOP

90S-0308 Generic Drug Speeches & Policy and Procedure Guides

M 634 HFD-7 Vol#: 43

M 635 HFD-7 Vol#: 43

M 636 HFD-7 Vol#: 43

M 637 HFD-7 Vol#: 43

M 638 HFD-7 Vol#: 43

TOP

93N-0462 Debarment of Abu Quamruzzaman

ANS 1 HFD-7 Vol#: 1

CR 1 Abu Quamruzzaman Vol#: 1

TOP

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

LET 4 HFS-165 to National Assn. of Margarine M Vol#: 21

TOP

98D-0785 Medical imaging drugs and biologics

C 12 Medicine Imaging Contrast Agent Assn etc Vol#: 2

98H-0736 Civil Money Penalties;Crown Central Petroleum Corp

MO 2 Crown Central Petroleum Corp Vol#: 1

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

C 600 Virginia Hamill Vol#: 12

C 601 Michelle Watson Vol#: 12

C 602 Maria Weber Vol#: 12

C 603 Malika Crozier Vol#: 12

C 604 T. Telster Vol#: 12

C 605 Barbara J. Bogner Vol#: 12

C 606 Dorothy Saxe Vol#: 12

C 607 Clorindar Forte-Katz Vol#: 12

C 608 Harriet Greene Vol#: 12

C 609 Nancy Ippolito Vol#: 12

C 610 Madera Roja de la Secoya Vol#: 12

C 611 Carter Scholz Vol#: 12

C 612 Center for Occupational & Environ Med Vol#: 12

C 613 Betsy Gilbert Vol#: 12

C 614 Dalaney Shoemaker Vol#: 12

C 615 Deborah Ings Vol#: 12

C 616 Jo Ann Herbert Vol#: 12

C 617 LaRue Kreiser Vol#: 12

C 618 Sandra Rodriguez Vol#: 12

C 619 Michel Malter Vol#: 12

C 620 W. Vachal Vol#: 12

C 621 Happy Bradford Vol#: 12

C 622 Erde Sun Vol#: 12

C 623 Mark Baven Vol#: 12

C 624 College of Business Admin & Economics Vol#: 12

C 625 Michael Brush Vol#: 12

C 626 Sarah Greuel Vol#: 12

C 627 James E. Briones Vol#: 12

C 628 Saint Mary's College Vol#: 12

C 629 Ellie MacDougall Vol#: 12

C 630 Barbara F. Slesinger Vol#: 12

C 631 Sean Clancy Vol#: 12

C 632 Annalee P. Cobbett Vol#: 12

C 633 Ernest Goitein Vol#: 12

C 634 Mary E. Blair Vol#: 12

C 635 Lynne Ihistrom Vol#: 12

C 636 Katherine Stuber Vol#: 12

C 637 William F. Zieske Vol#: 12

TOP

98N-1265 Distribution of Compounded Drug Products

C 1020 Rosemary Barta Vol#: 58

C 1021 Mary Ellen Wurm Vol#: 58

C 1022 Colleen Rockwell Vol#: 58

C 1023 Janean Jansen Vol#: 58

C 1024 Carol Clark Vol#: 58

C 1025 S. S. Elms Vol#: 58

C 1026 Margaret P. Neilson Vol#: 58

C 1027 Manja Sands Vol#: 58

C 1028 Lawrence Vol#: 58

C 1029 Barbara Hall Vol#: 58

C 1030 Martha J. Harrell Vol#: 58

C 1031 Grace A. Klinger Vol#: 58

C 1032 Carol A. Cousin Vol#: 58

C 1033 Tom Bader Vol#: 58

C 1034 Johanna C. Rogue Vol#: 58

C 1035 Fran Peront Vol#: 58

C 1036 Billie Schwarz Vol#: 58

C 1037 Margie Stanley Vol#: 58

C 1038 Sheila J. Vesper Vol#: 58

C 1039 Kathleen Stokes Vol#: 58

C 1040 Algia S. Green Vol#: 58

C 1041 Kathleen E. Turner Vol#: 58

C 1042 Jolene Bau Vol#: 58

C 1043 Cassandra Herrman Vol#: 58

C 1044 Anne H. Woehtel Vol#: 58

C 1045 Marie Lazer Vol#: 58

C 1046 Gail R. Solberg Vol#: 58

C 1047 Angela Hypell Vol#: 58

C 1048 Sandra Ahura Vol#: 58

C 1049 Mary Colleen Johnson Vol#: 58

C 1050 Barbara L. Boone Vol#: 58

C 1051 Nina L. Young Vol#: 58

C 1052 Laraine Silberstein Vol#: 58

C 1053 Joyce Matozzi Vol#: 58

C 1054 Marie Comstoch Vol#: 58

C 1055 A..... P..... Vol#: 58

C 1056 Susan Mastruzzo Vol#: 58

C 1057 Sylvia Hankin Vol#: 58

C 1058 Carol Nolden Vol#: 58

C 1059 Linda Wind Vol#: 58

C 1060 Jannie Banuerre Vol#: 58

C 1061 Ulrich Bauman Vol#: 58

C 1062 Anne Deloria Vol#: 58

C 1063 Sherry Carpenter Vol#: 58

C 1064 Georgiana Mansella Vol#: 58

C 1065 Louise Quarte Vol#: 58

C 1066 Joseph Friedrich Vol#: 58

C 1067 Beverly Harper Vol#: 58

C 1068 Jayne Brown Vol#: 58

C 1069 Chris Southworth Vol#: 58

C 1070 Mary F. Hendershort Vol#: 58

C 1071 Cheryl A. Black Vol#: 58

C 1072 Jamilla Dawson Vol#: 58

C 1073 Christina M. Smith Vol#: 58

C 1074 Mary Bond Vol#: 58

C 1075 Pamela Gravayne Vol#: 58

C 1076 Russell W. Teets Vol#: 58

C 1077 Andrea J. Cheszeh Vol#: 58

C 1078 Terry Baltz Vol#: 58

TOP

98P-0203 Eliminate Forced Molting of Laying Birds

C 898 James Fornado Vol#: 22

C 899 M. J. Brooks Vol#: 22

C 900 Daphne F. Willard Vol#: 22

C 901 Theresa Derose Vol#: 22

C 902 Pat Wyns Vol#: 22

C 903 Jennifer Vock Vol#: 22

C 904 Lorna Kramer Vol#: 22

C 905 Megan Cooney Vol#: 22

C 906 Iva Prince Vol#: 22

C 907 Gloria Hafner-Allee Vol#: 22

C 908 Toni Siegrist Vol#: 22

C 909 Glenda Spivey Vol#: 22

C 910 Christina Bennett Vol#: 22

C 911 Marie Barnath Vol#: 22

C 912 Christine Lin Vol#: 22

C 913 Charmaine Curry Vol#: 22

C 914 Marti Bono Vol#: 22

C 915 Hildegard Rodgers Vol#: 22

C 916 Marilynn Mitchell Vol#: 22

C 917 P. Patrick Vol#: 22

C 918 Dale Murphy Vol#: 22

C 919 Rita Brinkman Vol#: 22

C 920 Lyn Rosen Vol#: 22

C 921 No Signature Vol#: 22

C 922 Phyllis White Vol#: 22

C 923 Patricia Strope Vol#: 22

C 924 Kammie Kettelle Vol#: 22

C 925 Alma Blackwelder Vol#: 22

C 926 Drs. Sondra & Alex Rosiewicz Vol#: 22

C 927 Karein van der Lee Vol#: 22

C 928 Emily A. Hunger Vol#: 22

C 929 Jill Zeller Vol#: 22

C 930 Dorothea J. S. Goetz Vol#: 22

C 931 Alfred Wrannelmeyer Vol#: 22

C 932 Hope Master Vol#: 22

C 933 Voices For Animals Vol#: 22

C 934 Bazanian Goadfy Vol#: 22

C 935 Lily Sanders Vol#: 22

C 936 Leona M. Fowler Vol#: 22

C 937 Stacy Williams Vol#: 22

C 938 Susan Allen Vol#: 22

C 939 Donna Matthews Vol#: 22

C 940 Douglas & Elvira Rivalsi Vol#: 22

C 941 Jackie Wilson Vol#: 22

C 942 Barbara L. Pizzini Vol#: 22

C 943 Amy Love Vol#: 22

C 944 The Fund for Animals Inc. Vol#: 22

C 945 M. Culva Vol#: 22

C 946 Pamela A. Logan Vol#: 22

C 947 Jane Viti Vol#: 22

C 948 Amy McBride Vol#: 22

C 949 Sid Baskin Vol#: 22

C 950 Susan J. Tabor Vol#: 22

C 951 C. C. Lilley Vol#: 22

C 952 Mr & Mrs F. V. Schneider Vol#: 22

C 953 Brenda Prie Vol#: 22

TOP

98P-0968 Guidance regarding Surimi Ingredient Labeling

BKG 1 Vol#: 2

NPR 1 Vol#: 1

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

C 2 Mission Possible International Vol#: 1

99H-0071 Civil Money Penalties;Eastern Petroleum Corp,d/b/a E P Mart

ANS 1 Eastern Petroleum Corp Vol#: 1

99H-0446 Civil Money Penalties;Honey Farms Inc,d/b/a Honey Farms

ANS 1 Honey Parms Inc Vol#: 1

99H-0454 Civil Money Penalties;Ramco Inc,d/b/a Minit Mart #35

ANS 1 Ramco Inc Vol#: 1

99H-0837 Civil Money Penalties;The Southland Corp,d/b/a 7-Eleven

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0838 Civil Money Penalaties;Honey Farms Inc,d/b/a Honey Farms Min

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0839 Civil Money Penalties;Alfred Cabbler,d/b/a Boron Food Mart

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0840 Civil Money Penalties;Stop in Food Stores Inc,d/b/a Stop in

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0841 Civil Money Penalties;Revco Discount Drug Ctrs Inc,d/b/a CVS

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0842 Civil Money Penalties;McLain Oil Co Inc,d/b/a Diamond Shamro

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0843 Civil Money Penalties;Short Stop Inc,d/b/a Short Stop #2

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0844 Civil Money Penalties;Town & Country Food Stores Inc,d/b/a

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0845 Civil Money Penalties;Swifty Oil Co Inc,d/b/a Swifty Oil

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0846 Civil Money Penalties;P P Raj Inc,d/b/a Quick Mart #2

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0847 Civil Money Penalties;Raj Food Corp,d/b/a Getty Mart

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0848 Civil Money Penalties;Spaceway Oil Co Inc,d/b/a Spaceway Oil

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0849 Civil Money Penalties;Vimla Rai,d/b/a Wee Land Supermarket

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0850 Civil Money Penalties;Kolter Enterprises Inc,d/b/a K P's Mar

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0851 Civil Money Penalties;Halim Karim,d/b/a Variety Foods & Beve

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0852 Civil Money Penalties;Town & Country Food Stores Inc,d/b/a

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0853 Civil Money Penalties;McLain Oil Co Inc,d/b/a Diamond Shamro

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0854 Civil Money Penalties;Elvis Shaw,d/b/a South-Side Mart

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0855 Civil Money Penalties;Clarence Osborne & Anne Osborne,d/b/a

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0856 Civil Money Penalties;United Supermarkets Inc,d/b/a United

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

NPH 1 HHS/FDA/CDER Vol#: 1

99N-0188 Progestational Drug Products for Human Use

NPR 1 Vol#: 1

99N-0391 International Guidelines on Vitamin and Mineral supplements

N 1 Vol#: 1

99N-0486 Physician Labeling and Patient Labeling for Progestational

N 1 Vol#: 1

99V-0771 The Laser Tweezer Model Class IIIB

VRA 1 HFZ-300 to Cell Robotics Inc. Vol#: 1

TOP