Food and Drug
Administration, Dockets Management
Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852;
301-827-6860; Fax 301-827-6870 [E-mail]
DOCKETS ENTERED on July 22, 1999 Table of Contents(Hyper links are part of the Docket title - not all dockets/documents are linked) |
96N-0417 CGMP in Packing or Holding Dietary Supplements * 98N-0583 Exports: Notification and Recordkeeping requirements * 98N-1038 Irradiation in the production, processing, &handling of food * 98N-1265 Distribution of Compounded Drug Products * 99N-1174 Development of Strategy for Dietary Supplements * 99N-1270 New Monographs, Revisions of Certain Food Chemicals Codex * 99N-1737 Cinical trials for Investigational devices Intended to treat * 99P-1340 Declared Eternity eau de Parfum Misbranded * |
C 87 Pharma Chemie Inc Vol#: 3
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs
NPR 1 Vol#: 2
97P-0197 Require that warning labels about risks of salmonella enteri
NPR 1 Vol#: 1
98C-0041 Amend Regulations for the safe use of copper in coloring
NCD 1 Vol#: 1
98N-0583 Exports: Notification and Recordkeeping requirements
C 13 Genzyme Tissue Repair Vol#: 2
C 14 Epic Medical Equipment Services Vol#: 2
C 15 Alpha Therapeutic Corporation Vol#: 2
C 17 Pharmacia & Upjohn Vol#: 2
C 18 R W Johnson Pharmaceutical Research Inst Vol#: 2
98N-0617 Treatment of Narcotic Dependence
NPR 1 Vol#: 1
98N-1038 Irradiation in the production, processing, &handling of food
C 3772 Scott Emanuel Vol#: 100
C 3774 Berenice Macon Vol#: 100
C 3775 James J. Rede Vol#: 100
C 3776 David L. Keller Vol#: 100
C 3777 Patricia A. Gerry Vol#: 100
C 3778 Vivian Pruett Vol#: 100
C 3779 Bethany Bogosian Vol#: 100
C 3782 Juliette Bennett Vol#: 100
C 3783 Harriet Hezel Vol#: 100
C 3784 Elizabeth Johnston Vol#: 100
C 3787 Melanie K. Daniels Vol#: 100
C 3791 Michael Sorkin Vol#: 100
C 3793 George S. Price Vol#: 100
C 3794 Sonia Sandieas Vol#: 100
C 3797 Edward J. Bond Vol#: 100
C 3798 Kristen P. Dolgos Vol#: 100
C 3799 Jessica Lynn Saigh Vol#: 100
C 3800 Amanda Graddy Vol#: 100
C 3801 Phyllis Friedman Vol#: 100
C 3804 Robert A. Saigh Vol#: 100
C 3805 David Gershon Vol#: 100
C 3806 Mike Bitzenburg Vol#: 100
C 3807 Dianne Schfer Vol#: 100
C 3809 Anne Somervill Vol#: 100
C 3810 Ginette G. Walker Vol#: 100
C 3812 Andy Ruggenberg Vol#: 101
C 3814 Edith L. Gordon Vol#: 101
C 3818 Sherine Toppozada-Tully Vol#: 101
C 3820 Cynthia Neuendorff Vol#: 101
C 3821 Roberta Ludlow Vol#: 101
C 3823 Elaine Chapnik Vol#: 101
C 3825 American Assn of Nutritional Consultants Vol#: 101
C 3826 Davina Williams Duerr Vol#: 101
C 3829 Thomas Jefferson Vol#: 101
C 3830 Audrey W. Katz Vol#: 101
C 3834 Gretchen Grey-Hatton Vol#: 101
C 3836 Dorothy T. Gurry Vol#: 101
C 3837 Harold Neuendorff Vol#: 101
C 3838 Harry H. Johnson Vol#: 101
C 3839 Mr. & Mrs. Don & Rebecca Horst Vol#: 101
C 3844 Lee Carrington Vol#: 101
C 3845 Amy McSweeney Vol#: 101
C 3846 Charles Reeder Vol#: 101
C 3847 Harvey Wasserman Vol#: 101
C 3848 Patricia Salinger Vol#: 101
C 3849 Paul Swanson, M.D. Vol#: 101
C 3850 Doug Schiffli Vol#: 101
C 3852 Ross A. Leventhal Vol#: 101
C 3853 Rebecca Herman Vol#: 101
C 3854 Virginia Schaefer Vol#: 101
C 3855 Mary & Raumond Sell Vol#: 101
C 3856 Sharina White Vol#: 101
C 3857 Stuart Geltner Vol#: 101
C 3861 Beatrice Townsend Vol#: 101
C 3862 Dr. JoJo Yonce Vol#: 101
C 3863 Sibyl L. S. Wessler Vol#: 101
C 3864 Rasha Toppozada-Yow Vol#: 101
C 3865 Charles C. Harris Vol#: 101
C 3866 Dr. Richard Way Vol#: 101
C 3867 Deborah Hoffman Vol#: 101
C 3868 Matthew J. Giuffrida Vol#: 101
C 3869 Dr. Victoria Rea Vol#: 101
C 3871 Diane Forkeutis Vol#: 101
C 3872 John Paskiewicz Vol#: 101
C 3873 Paul van Gulick, PE Vol#: 101
C 3875 Camille Brady Vol#: 101
C 3877 Janelle Brady Vol#: 101
C 3878 Ingeborg Buckley Vol#: 101
C 3880 Majorie Williams Vol#: 101
C 3881 Angelica Williams Vol#: 101
C 3884 Suzanne Janis Vol#: 101
C 3885 May Swartzbaugh Vol#: 101
C 3887 Harvey M. Hoffman Vol#: 101
C 3888 Healthy Healing Publications Vol#: 101
C 3889 Healthy Healing Publications Vol#: 101
C 3892 Marsha M. Campbell Vol#: 101
C 3893 15 signatures Vol#: 101
C 3894 Mr. Veet Deha Vol#: 101
C 3895 Brigette Raing Vol#: 101
C 3896 Patricia B. Holbrook Vol#: 101
C 3897 William T. Schilling Vol#: 101
C 3898 Mariantle Bezzerides Vol#: 101
C 3900 Bernadette Fernandez Vol#: 101
C 3901 Michael Shorr Vol#: 101
C 3902 Meredith W. Baldridge Vol#: 101
C 3907 Judith Chaddick Vol#: 101
C 3908 Katherine Imislund-Clarke Vol#: 101
C 3913 Kathleen M. Kehoe Vol#: 102
C 3914 Aja Myers-Taylor Vol#: 102
C 3916 Robert Harrison Vol#: 102
C 3918 Mrs. Brooks Wakefield Vol#: 102
C 3919 Carly Gilchrist Vol#: 102
C 3920 Dushenka Myers-Taylor Vol#: 102
C 3921 Elizabeth R. Hurvich Vol#: 102
C 3922 Elise Rugolo-Crowe Vol#: 102
C 3926 Eileen Dannemann Vol#: 102
C 3927 Shaklee Corp. Vol#: 102
C 3928 Jennet Grover Vol#: 102
EXT 38 Audrey N. Horbeck Vol#: 101
EXT 39 A. J. Jewis, Ph.D. Vol#: 101
98N-1265 Distribution of Compounded Drug Products
C 3831 Doris J Barbee Vol#: 138
C 3833 Jim & Christene Pursley Vol#: 138
C 3838 Camille Brand Vol#: 138
C 3839 Elizabeth Hammerman Vol#: 138
C 3840 Silvia Garcia Vol#: 138
C 3841 Louise Bassett Vol#: 138
C 3844 Sally J Kesler Vol#: 138
C 3845 Maria Catrambone Rosen Vol#: 138
C 3847 Viola Colleth Vol#: 138
C 3848 Cecilia Teran Vol#: 138
C 3849 Nancy D Visotsky Vol#: 138
C 3850 Sherrie Shatzen Vol#: 138
C 3852 Joyce Simmons Vol#: 138
C 3853 Joyce Herschbeyer Vol#: 138
C 3854 Reba Thurmond Vol#: 138
C 3856 Pamela Strover Vol#: 138
C 3857 Barbara Powell Vol#: 138
C 3858 Michelle Tratnik Vol#: 138
C 3862 Christine Bell Vol#: 138
C 3863 Linda Prewitt Vol#: 138
C 3864 Evelyn Carrol Vol#: 138
C 3866 Patricia Murphy Vol#: 138
C 3867 Cheryl Gigliotti Vol#: 138
C 3869 Delores K Holmgren Vol#: 138
C 3870 Susan E Buckley Vol#: 138
C 3871 Joan M Gradinian Vol#: 138
C 3872 Pamela Michalak Vol#: 138
C 3873 Ruth A Schweinfurth Vol#: 138
C 3875 Victoria Wilson BS Vol#: 138
C 3876 Janet L Atkins Vol#: 138
C 3877 Mrs Ruby Patt Vol#: 138
C 3879 Mrs Evelyn Lucas Vol#: 138
C 3880 Lawrence M Porter MD Vol#: 138
C 3882 Doris F Barbee Vol#: 138
C 3883 Audrey E Guiliano Vol#: 139
C 3884 Margaret F Jess Vol#: 139
C 3887 Felice Lafair Vol#: 139
C 3888 John H Boyles Jr, MD Vol#: 139
C 3889 Dorothy Giebutowski Vol#: 139
C 3890 Leslie DeRoos Vol#: 139
C 3892 Jolene Geier OP Vol#: 139
C 3893 Caryn L DePauw Vol#: 139
C 3898 Yvonne Edmundson Vol#: 139
C 3899 Norma Gottschah Vol#: 139
C 3900 Michelle Schwartz Vol#: 139
C 3901 Collum Peterson Vol#: 139
C 3902 Terri Roberts Vol#: 139
C 3903 Ed & Linda Rone Vol#: 139
C 3904 Sheldon C Deal DC N MD Vol#: 139
C 3905 George Michael Miles NMD Vol#: 139
C 3906 Autumn E Holder NMD Vol#: 139
C 3907 Carolyn S Layne Vol#: 139
C 3908 Kay Melby Vol#: 139
C 3909 Marion Bailey Vol#: 139
C 3910 Irene Pillsbury Vol#: 139
C 3911 L Conoscenti Vol#: 139
C 3912 Jean Zawlocki Vol#: 139
C 3913 Sybil R Zava Vol#: 139
C 3914 Ms Patricia A Garcia Vol#: 139
C 3915 Marshall Vol#: 139
C 3916 Jan Heckroth Vol#: 139
C 3917 Florence C Blackwell Vol#: 139
C 3918 Nancy M Clark Vol#: 139
C 3919 Junell L Holmer Vol#: 139
C 3920 Yolanda F Yellin Vol#: 139
C 3921 Carolyn G Jordan Vol#: 139
C 3922 Barbara A Nora Vol#: 139
C 3923 Pamela Miller Vol#: 139
C 3924 Paul J Franks Vol#: 139
C 3925 Nancy Jill Strong Vol#: 139
C 3926 Dorothy L Marchetti Vol#: 139
C 3927 Thelma Breen Vol#: 139
C 3928 Loretta Bernard Vol#: 139
C 3929 Carol H Holmes Vol#: 139
C 3930 Karen Traverse Vol#: 139
C 3931 Dolores L McDermott Vol#: 139
C 3932 Connie L VanDerTurck Vol#: 139
C 3933 Kathleen Raut Vol#: 139
C 3934 Antonette Gillen Vol#: 139
C 3935 Mary L Daybtudge Vol#: 139
C 3936 Cheryl Burns Vol#: 139
C 3937 Muriel Eagle Vol#: 139
C 3938 Carole A Merriel Vol#: 139
C 3939 Lucille D Kester Vol#: 139
C 3940 William E Sission Vol#: 139
C 3941 Jane P Cowan Vol#: 139
C 3942 Linda Lacy-Shearer Vol#: 139
C 3943 Judith Child Vol#: 139
C 3944 Sally Tucker Vol#: 139
C 3945 Mary Anne Barry Vol#: 139
C 3946 Penny L Tracy Vol#: 139
C 3947 Patricia Brush Vol#: 139
C 3948 Lois Kawut Vol#: 139
C 3949 Mitchell A Fleisher MD Vol#: 139
C 3950 June P Bent Vol#: 139
C 3951 J Stanwich Vol#: 139
C 3952 Catharin Schimert Vol#: 139
C 3953 Robert Miller PhD Vol#: 139
C 3954 Courtney C Blossman Vol#: 139
C 3955 Eva B Hawkins Vol#: 139
C 3956 Barbara Cardea-Weismann Vol#: 139
C 3957 Barbara Gray Vol#: 139
C 3958 Terry Rubin Vol#: 139
C 3959 Suzanne H Dillard Vol#: 139
C 3960 Eillen Horrell Vol#: 139
C 3961 Kathleen Lyons Vol#: 139
C 3962 Mary Ann Johnson Vol#: 139
C 3963 Bonita Zdrale Vol#: 139
C 3964 Martha Novak Vol#: 139
C 3965 Diane R Rogers Vol#: 139
C 3966 Ms Sheila Avruch Vol#: 139
C 3967 C Heine Vol#: 139
C 3968 Evie Johnson Vol#: 139
C 3969 Miriam Pzena Vol#: 139
C 3970 Cynthia Little Vol#: 139
C 3971 Juanita Goodyear Vol#: 139
C 3972 Karen Culbertson Vol#: 139
C 3973 Shelli Wellman Vol#: 139
C 3974 Cathy Sremba Vol#: 139
C 3975 Deborah J Wagner Vol#: 139
C 3976 Frank P Trnka Vol#: 139
C 3977 J Marlene Stalker Vol#: 139
C 3978 Judith C Higley Vol#: 139
C 3979 Cheryl Dodson Vol#: 139
C 3980 L Khano Vol#: 139
C 3981 Christy Blue Vol#: 139
C 3982 Lorraine Connors Vol#: 139
C 3983 Sandis L Croner Vol#: 139
C 3984 Dennis E Pawl Vol#: 140
C 3987 Charlene Duranceau Vol#: 140
C 3988 Patsy A Wayno Vol#: 140
C 3989 Margaret Berg Vol#: 140
C 3990 Linda B Platt Vol#: 140
C 3992 Maureen Daley Vol#: 140
C 3994 Marcia Kopterous Vol#: 140
C 3995 Kathleen Foraker Vol#: 140
C 3996 Diana S Darby Vol#: 140
C 3997 Kathryn Z Sell Vol#: 140
C 3998 Susan S Fairbanks Vol#: 140
C 3999 Judith L Isaacson Vol#: 140
C 4000 Barbara Davis Vol#: 140
C 4001 Margaret Lijewski Vol#: 140
C 4002 Beverly Wilkerson Vol#: 140
C 4003 Comstock & Cooper Vol#: 140
99D-1458 Enforcement Policy for FDA Personnel/Electronic Records& Sig
NAD 1 HFC-230 Vol#: 1
99D-2215 Impurities in New Veterinary Drug Substances
GDL 1 Vol#: 1
NAD 1 Vol#: 1
99D-2249 Technical Requirements for VICH
GDL 1 Vol#: 1
NAD 1 Vol#: 1
99F-2336 Safe use of manganese ammonium pyrophospate as colorant/food
EA 1 HFS-024 Vol#: 1
NFL 1 Holliday Pigments Ltd Vol#: 1
99H-2263 Civil Money Penalty;Barry Baggett,dba Baggett's Chevron
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2264 Civil Money Penalty;Cumberland Farms Inc,dba Cumberland Farm
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2265 Civil Money Penalty;CVS Revco D S Inc,dba CVS Pharmacy #4549
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2266 Civil Money Penalty;CVS Pharmacy Inc,dba CVS Pharmacy #4246
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2267 Civil Money Penalty;D & D Grocery & Deli Inc,dba D & D Groce
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2268 Civil Money Penalty;Friendly Express Inc,dba Friendly Expres
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2269
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2270
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2271 Civil Money Penalty;Golden Pantry Food Stores Inc,dba Golden
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2272 Civil Money Penalty;Ray Griffin,dba Battlecreek Amoco
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2274 Civil Money Penalty;Rose W Johnson,dba Johnson's Package Sto
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2275 Civil Money Penalty;Anthony E Jones,dba Anthony's Amoco
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2276 Civil Money Penalty;Nasir Shah Khankah,dba Newman Crossings
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2277 Civil Money Penalty;Phillips Gas Co,dba Phillips 66
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2278 Civil Money Penalty;Howard Riley,dba H & R Grocery
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2279 Civil Money Penalty;Joseph Sousa,dba Sousa's Market
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2280 Civil Money Penalty;Speedway Superamerica LLC,dba Superameri
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2281 Civil Money Penalty;Town Lounge Inc,dba Town Lounge
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2282 Civil Money Penalty;Hassan Yatim,dba Pleasant Street Exxon
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99N-0123 Procedures for Statements on Dietary Supplements
NAL 1 Vol#: 1
S 1 Vol#: 1
99N-0124 Premarket Notification for a New Dietary Ingredient
NAL 1 Vol#: 1
S 1 Vol#: 1
99N-1174 Development of Strategy for Dietary Supplements
C 33 American Medical Women's Association Vol#: 1
99N-1270 New Monographs, Revisions of Certain Food Chemicals Codex
99N-1392 Agency Information Collection: State Enforcement Notificatio
NCR 1 Vol#: 1
99N-1737 Cinical trials for Investigational devices Intended to treat
EXT 1 HIMA Vol#: 1
99N-1819 Topical Antifungal Drug Products
NPR 1 Vol#: 1
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock
C 1180 Form Letters Count 8 Vol#: 19
99P-1340 Declared Eternity eau de Parfum Misbranded
21