FDA - Food and Drug Administration |
DOCKETS ENTERED on APRIL 12, 1999
Updated as of 10:00 am, April 15, 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.
77N-0085 Saccharin and Its Salts
CA 27000 R J Huber Vol#: 424
CA 27001 M L Densmore Vol#: 424
CA 27002 E Keith Vol#: 424
CA 27003 F Dahl Vol#: 424
CA 27004 M L Sanders Jr. Vol#: 424
CA 27005 D E Andrews Vol#: 424
CA 27006 R S Dubrusson Vol#: 424
CA 27007 T Angelo Vol#: 424
CA 27008 E H Power Vol#: 424
CA 27009 N & H B Stanley Vol#: 424
CA 27010 R L Brown Vol#: 424
CA 27011 J Vannoy Vol#: 424
CA 27012 A J & P M Galloway Vol#: 424
CA 27013 L M Wilkinson Vol#: 424
CA 27014 S Muths Vol#: 424
CA 27015 H Richman Vol#: 424
CA 27016 L L Hart Vol#: 424
CA 27017 M F Weston Vol#: 424
CA 27018 L Butler Vol#: 424
CA 27019 R E Krol Vol#: 424
CA 27020 L K Schenck Vol#: 424
CA 27021 B R Albert Vol#: 424
CA 27022 J Browning Vol#: 424
CA 27023 R McDonnell Vol#: 424
CA 27024 P Pennington Vol#: 424
CA 27025 M Tippett et al Vol#: 424
CA 27026 D Salmon Vol#: 424
CA 27027 H M Nisoufer Vol#: 424
CA 27028 E E Olson Vol#: 424
92N-0139 Statement Policy: Foods Derived from New Plant Varieties
C 4999 Marilee S. Williams Vol#: 77
C 5001 Marjorie W. Chodack Vol#: 77
94F-0246 Safe Use of Ethylene-vinyl Acetate-vinyl Alcohol Copolymers
EA 1 Kuraray Company Ltd Vol#: 1
95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability
C 3687 Honorable Ralph M Hall (CI) Vol#: 291
96G-0096 Safe use of solin oil
NWL 1 Vol#: 1
96N-0135 Protein Derived from Ruminants Prohibited in Ruminant Feed
C 1683 Evelyn Uselmann Vol#: 86
C 1684 Nancy Kanerick Vol#: 86
97D-0483 Food-Effect Bioavailability and Bioequivalence Studies
C 11 PharmaKinetics Laboratories Inc Vol#: 1
98D-0469 Labeling of OTC drug products/treatment of vaginal yeast inf
TR 1 September 11, 1998 meeting Vol#: 2
98D-0994 Draft Guidance for Industry on BACPAC I
C 28 National Assn of Pharmaceutical Mfg Vol#: 1
C 29 Geneva Pharmaceuticals, Inc Vol#: 1
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa
C 40 Illinois Stewardship Alliance Vol#: 2
C 41 National Turkey Federation Vol#: 2
98H-1137 Civil Money Penalties;Sky Chefs Inc,d/b/a LSG Sky Chefs
LET 2 Office of Tobacco Programs HF-11) Vol#:
WDL 1 GCF-1 Vol#: 1
98H-1202 Civil Money Penalties; Lake Sammamish Mini Mart Inc
ANS 1 LSMM Vol#: 1
98N-0583 Exports: Notification and Recordkeeping requirements
REF 1 OMB, OIRA Vol#: 1
98N-0826 Dietary Supplements of Health Claims
C 16 American Herbal Products Association Vol#: 1
98N-1038 Irradiation in the production, processing, &handling of food
C 535 Mr & Mrs George Landon Vol#: 11
C 537 Michele L. DeAscentis Vol#: 11
C 538 Ronald E. DeAscentis Vol#: 11
C 543 Richard L. Christie Vol#: 11
C 544 Charles M. Carletta Vol#: 11
C 546 M. Ruth Niswander Vol#: 11
C 548 April Angelene Parker Vol#: 11
C 549 Laura E. Gibbons Vol#: 11
C 550 Sonia Siegel-Vexler Vol#: 11
C 551 Kenneth R. Niswander Vol#: 11
C 552 Mele Stokesberry Vol#: 11
C 559 Sasha Albertini Vol#: 11
C 560 Tiffany DiMascio Vol#: 11
C 564 Kimberly Lesser Vol#: 11
98N-1265 Distribution of Compounded Drug Products
C 930 Cynthia L. Wall Vol#: 58
C 931 Roger L. Kroeze Vol#: 58
C 932 Lee & Melanie Beasley Vol#: 58
C 933 Brian & Laurel Hines Vol#: 58
C 934 Carolyn N. Surknet Vol#: 58
C 936 Carolyn P. Shelburne Vol#: 58
C 937 Delores A. Shaw Vol#: 58
C 939 Ethel P. Thompson Vol#: 58
C 940 David R. Bonfiglio Vol#: 58
C 941 Carolee V. Thomson Vol#: 58
C 943 Dorothy Scholl Barclay Vol#: 58
C 945 Kathylyn Carroll Vol#: 58
C 950 Pamela Anderegg Vol#: 58
C 952 Ed & Cathie Khouri Vol#: 58
C 959 Vicki A. Spicer Vol#: 58
C 960 Wava E. Markwardt Vol#: 58
C 965 Ethlie Ann Vare Vol#: 58
C 968 Rosemary D. Amoroso Vol#: 58
C 969 Alison K. Hazelbaker Vol#: 58
C 970 Janelle McKinley Vol#: 58
C 972 Jearette Carron Vol#: 58
C 973 Kathryn Wirtala Vol#: 58
C 974 Carla Paganelli Vol#: 58
C 977 Violet Allison James Vol#: 58
C 981 Diana D. Matlack Vol#: 58
C 982 Alice E. Arrigo Vol#: 58
C 984 Jody E. Bridges Vol#: 58
C 985 Chris Ziolkowski Vol#: 58
98P-0043 Permit the label statement of "Supplement Facts"
C 6 American Herbal Products Association Vol#: 1
C 7 Council for Responsible Nutrition Vol#: 1
98P-0151 Introduction Of Downed Cattle Into The Food Supply
C 2073 Alice A. Crawford Vol#: 52
C 2075 Linette Barker Vol#: 52
C 2076 Helene Dickard Vol#: 52
C 2077 Vera E. Larson Vol#: 52
98P-0203 Eliminate Forced Molting of Laying Birds
C 819 Storm Kai Balchunas Vol#: 21
C 823 Kristy L. Boettler Vol#: 21
C 824 Mindy S. Kursban Vol#: 21
C 825 Christina J. Babst Vol#: 21
C 826 Natalie M. Diehl Vol#: 21
C 827 Pam Pepperell & Carl Scott Vol#: 21
C 830 Beverly D. Conley Vol#: 21
C 831 Amrit C. Hansmeyer Vol#: 21
C 833 Pamela H. Polcyn Vol#: 21
C 834 Juliet van Otteren Vol#: 21
C 835 Suzanna Hermans Vol#: 21
C 836 William V. Stewart Vol#: 21
C 838 David J. Gilbert Vol#: 21
C 840 Roger Montgomery Vol#: 21
C 845 Grace A. Golling Vol#: 21
C 847 Martine Sankari Vol#: 21
C 856 Christine Ostopoff Vol#: 21
C 860 Jennifer Plyler Vol#: 21
C 864 Elaine I. Woodriff Vol#: 21
C 865 Debora A. Kane & Tom Whitaker Vol#: 21
C 866 Florence L. Orth Vol#: 21
98P-0504 Raw Molluscan Shellfish of Undetectable Levels
C 13 Public Voice for Food & Health Policy Vol#: 1
C 15 Form Letter 117 Vol#: 3
C 16 Michael A. Marshall Vol#: 1
C 17 The Fisherman Harvest Vol#: 1
C 18 Washington St. Dept. of Natural Resource Vol#: 1
C 19 Premier Plastics div of Premier Ind.,Inc Vol#: 1
C 20 Harbor House Seafood, Inc. Vol#: 1
98P-0659 Allow to Place a Sticker Listing the Dry Natural Rubber Warn
98P-1121 Grated Parmesan Cheese Deviating from Identity standard
NTP 1 Vol#: 1
98P-1194 Withdrawal NADA Approval for Posilac - rBGH
98P-1227 Extension of compliance date for Std for Electrode Lead Wire
99D-0236 Skin Irriation/Sensitization testing of generic transdermal
C 2 Novum Pharmaceutical Research Services Vol#: 1
99D-0254 product name placement,size, & prominence in advertising
C 2 Jane Sinclair & Robert M Sinclair Vol#: 1
99D-0296 Fortmal Meetings with Sponsors/Applicant for PDUFA Products
NCR 1 Vol#: 1
99D-0297 Formal Dispute Resolution Appeals above the Division Level
NCR 1 Vol#: 1
99D-0302 Mammography Quality Standards Act Final Regs,Document #2
C 1 Indian Health Service Vol#: 1
C 2 Institute for Mammography Research Inc Vol#: 1
99D-0463 Adulteration involving hard or Sharp Foreign Objects
GDL 1 Vol#: 1
NAD 1 Vol#: 1
99D-0557 Use of Nonhuman Primate Xenografts in Humans
GDL 1 Vol#: 1
NAD 1 Vol#: 1
99F-0187 Neotame - Filing of Food Additive Petition (FAP 9A4643)
99F-0719 Safe use olestran place of fats and oils in prepackaged
EA 1 Vol#: 1
NFL 1 Procter & Gamble Co. Vol#: 1
99F-0720 Safe use hydrogenated aromatic petroleum hydrocarbon
EA 1 Vol#: 1
NFL 1 Arakawa Chemical Industries Vol#: 1
99H-0260 Civil Money Penalties;Bel Air Ent Inc,d/b/a Neptune's
ANS 1 Bel Air Ent. Inc. Vol#: 1
99H-0797 Civil Money Penalties;Wal-Mart Stores East Inc,d/b/a Wal Mar
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0798 Civil Money Penalties;Racetrac Petroleum Inc,d/b/a Racetrac
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0799 Civil Money Penalties;Anil Patel,d/b/a Shiv Food Mart
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0800 Civil Money Penalties;Rhadames Peguero,d/b/a Warren Super Ma
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0801 Civil Money Penalties;Kim Nguyn,d/b/a Rosemont Market
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0802 Civil Money Penalties;Deweese Ent Inc,d/b/a Super Stop #49
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0825 Civil Money Penalties;Lab Marketing,d/b/a Nothin' Butt Smoke
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0826 Civil Money Penalties;Wal-Mart Stores Inc,d/b/a Wal-Mart Sto
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0827 Civil Money Penalties;Angus I Hines Inc,d/b/a Sentry Food
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0828 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-0829 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-0830 Civil Money Penalties;Cumberland Farms Inc,d/b/a Cumberland
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0831 Civil Money Penalties;Supervalu Inc,d/b/a Cub Foods
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0832 Civil Money Penalties;Walgreen Co,d/b/a Walgreens Drug Store
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0833 Civil Money Penalties;Action Petroleum Co Ltd,d/b/a Action
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0834 Civil Money Penalties;J W Brewer Tire Co Inc,d/b/a Quick Sav
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0835 Civil Money Penalties;E-Z Mart Store Inc,d/b/a E-Z Mart #251
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0836 Civil Moneoy 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-0857 Civil Money Penalties; Acme Markets of Virginia Inc,d/b/a
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0858 Civil Money Penalties;Angus I Hines Inc,d/b/a Sentry Food
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0859 Civil Money Penalties;Autry Geer & Sons Inc,d/b/a Greer's 30
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0860 Civil Money Penalties;Suk Bowman,d/b/a Evergreen Shores Groc
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0861 Civil Money Penalties;Shelly Cox,d/b/a Cox's Chevron
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0862 Civil Money Penalties;Maria Escobar,d/b/a Casa De Oro
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0863 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-0864 Civil Money Penalties;Gibbs Oil Co Ltd,d/b/a Gibbs Oil
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0865 Civil Money Penalties;Tej Kaur,d/b/a Go Fer Supermarket
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0866 Civil Money Penalties;Asad Mohammadali & Farid Allana,d/b/a
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0867 Civil Money Penalties;Silva Pina,d/b/a El Frutero
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0868 Civil Money Penalties;Charles Scott,d/b/a Scott's IGA
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-0869 Civil Money Penalties;Lawrence Scott,d/b/a Scott's Variety
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99M-0870 PMA Urolume endoprosthesis for Detrusor Ext Sphincter Dyssyn
AAV 1 American Medical Systems, Inc Vol#: 1
99M-0871 PMA Cypress Bioscience, Prosorba Column
AAV 1 Cyrpess Bioscience Inc Vol#: 1
99M-0894 PMA Lumbar I/F Cage with VSP Spine System, P960025
AAV 1 DePuy AcroMed Inc Vol#: 1
99N-0386 Talking with Stakeholders About FDA Modernization
EC 1 Ohio Dept of Agriculture Vol#: 1
EC 2 Robert M & Jane Sinclair Vol#: 1
99N-0670 Labeling Requirements for Color Additives and Petitions
N 1 Vol#: 1
99P-0923 ANADA Suitability Petition for Miconazole Nitrate Cream 2%