FDA Logo links to FDA home page
U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

FDA Home Page | Dockets Home Page | Dockets Contacts and Location | Operating Status

horizonal rule

Dockets Management

Dockets Entered On May 9, 2007
Docket # Title
1977N-0094L Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment ot the Tentative Final Monograph; Required Warnings and Other Labeling
2000P-1322 Food Labeling and Allergen Contamination Control
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
2002P-0317 Recall Aspartame as a Neurotoxic Drug
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2003N-0573 Draft Animal Cloning Risk Assessment
2004E-0019 Patent Extension, FUZEON (enfuvirtide), U.S. Patent No. 6,133,418
2004E-0040 Patent Extension for CYDECTIN, U.S. Patent No. 4,916,154
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
2005N-0349 FDA Survey of Current Manufacturing Practices in the Food Industry
2005N-0413 Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
2005P-0459 To enforce ban on carbon monoxide gas in fresh meat packaging
2006D-0254 Guidance for Industry: Analytical Methods Description for Type C Medicated Feeds
2006D-0363 Guidance for Industry and Food and Drug Administration Staff; Draft Class II Special Controls Guidance Document: Absorbable Hemostatic Device
2006D-0441 Guidance for Industry: Protocols for the Conduct of Method Transfer Studies for Type C Medicated Feed Assay Methods
2006D-0480 Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
2006E-0031 Patent Extension Application for CLOLAR (clofarabine), U.S. Patent No. 5,661,136
2006E-0033 Patent Extension Application for APTIVUS (tipranavir), U.S. Patent No. 5,852,195
2006N-0362 General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
2006N-0476 Drug Products Containing Quinine; Enforcement Action Dates
2007D-0027 Voluntary Self Inspection of Medicated Feed Manufacturing Facilities
2007D-0117 Guidance for Industry on Orally Disintegrating Tablets
2007D-0137 Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis
2007N-0051 Safety of Fresh Produce; Public Hearings
2007N-0121 Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
2007N-0136 Medical Devices; Immunology and Microbiology Devices; Classification of Gene Expression Profiling Test System for Breast Cancer Prognosis
2007P-0085 Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
2007P-0093 Refuse to approve CIP-TRAMADOL ER until Cipher complies with the investigations Reports to show the safety and effectiveness of the drug
2007P-0127 Determine that any versions of tramadol for once-daily dosing will not be approved prior to expiration of three-year period of exclusivity for Ultram ER
2007P-0149 Canned Pacific Salmon Deviating From Identity Standard; Temporary Permit for Market Testing
2007P-0150 Iceberg Water Deviating From Identity Standard; Temporary Permit for Market Testing
2007P-0187 Requirements of Iodized Salt on Ingredient Labels
1977N-0094L Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment ot the Tentative Final Monograph; Required Warnings and Other Labeling
EREG 1 R. N.-B. S. N. Students for University of Virginia Vol #: 1
2000P-1322 Food Labeling and Allergen Contamination Control
EMC 619 D. Briggs Vol #: 30
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
EMC 1341 N. Thompson Vol #: 6
EMC 1342 J. Black Vol #: 6
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 801 Mission Possible International Vol #: 11
EMC 802 Mission Possible International Vol #: 11
EMC 803 Mission Possible International Vol #: 11
EMC 804 Mission Possible International Vol #: 11
EMC 805 Mission Possible International Vol #: 11
EMC 806 Calorie Control Council Vol #: 11
EMC 807 Mission Possible International Vol #: 11
EMC 808 Mission Possible International Vol #: 11
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 1483 D. D. D. S., Inc. Vol #: 12
EMC 1484 J. Waldie Vol #: 12
EMC 1485 S. McKay Vol #: 12
EMC 1486 R. H. Donnelley Vol #: 12
EMC 1487 B. Hirose Vol #: 12
2003N-0573 Draft Animal Cloning Risk Assessment
C 936 H.GAUDESSON Vol #: 68
C 937 L. KERZE Vol #: 68
C 938 O. MOON Vol #: 68
C 939 G. FREIRE Vol #: 68
C 940 M. DAYTON Vol #: 68
C 941 W. WETZELBERG Vol #: 68
C 942 D. MASON Vol #: 68
C 943 M. GRIMM Vol #: 68
C 944 C. PROHASKA Vol #: 68
C 945 A. ARMSTRONG Vol #: 68
C 946 R. DOWNEY Vol #: 68
C 947 T.LUND Vol #: 68
C 948 R. VASQUEZ Vol #: 68
C 949 S. WAKEFIELD Vol #: 68
C 950 K. FRANCIS Vol #: 68
C 951 S. RUSSO Vol #: 68
C 952 R. GIBSON Vol #: 68
C 953 S. HICKMAN Vol #: 68
C 954 M. GMUR Vol #: 68
C 955 A. CLITES Vol #: 68
C 956 M. BOTTONE Vol #: 68
C 957 T. MAGALLON Vol #: 68
C 958 T. COLLINS Vol #: 68
C 959 Y. BEAL Vol #: 68
C 960 D. MCKINNIS Vol #: 68
C 961 E. ROWLAND Vol #: 68
C 962 M. MCALEENAN Vol #: 68
C 963 C. CARPENTER Vol #: 68
C 964 M. EDINGER Vol #: 68
C 965 B. URBANCIC Vol #: 68
C 966 C. COUSINS Vol #: 68
C 967 L. WEBER Vol #: 68
C 968 R. THOMAS Vol #: 68
C 969 A. FLANNERY Vol #: 68
C 970 M. MCKINNEY Vol #: 68
C 971 T. SARDANELLI Vol #: 68
C 972 P. ALCID Vol #: 68
C 973 D. SENN Vol #: 68
C 974 D. STRONG Vol #: 68
C 975 Z. BARNES Vol #: 68
C 976 C. NELSON Vol #: 68
C 977 H. HEYDUK Vol #: 68
C 978 J. PERKINS Vol #: 68
C 979 M. FOLEY Vol #: 68
C 980 S. PENNEY Vol #: 68
C 981 N. CARMAN Vol #: 68
C 982 C. MEAD Vol #: 68
C 983 D. CHURCH Vol #: 68
C 984 M. BENNETT Vol #: 68
C 985 A. STEINBERG Vol #: 68
C 986 B. OPLINGER Vol #: 68
C 987 D. MADDEN Vol #: 68
C 988 L. DILLS Vol #: 68
C 989 C. HARRIS Vol #: 68
C 990 C. HARRIS Vol #: 68
C 991 N. Hardin Vol #: 68
C 992 J. HOLLAND Vol #: 68
C 993 B. RUELI Vol #: 68
C 994 K. KNIGHT Vol #: 68
C 995 L. MILLER Vol #: 68
C 996 K. ENGER Vol #: 68
C 997 B. RUBI Vol #: 68
C 998 R. D'ANGELO Vol #: 68
C 999 E. SCHICHT Vol #: 68
C 1000 N. WHITE Vol #: 68
C 1001 J. KALISZEWSKI Vol #: 68
C 1002 J. YANG Vol #: 68
C 1003 R. YANG Vol #: 68
C 1004 C. GREEN Vol #: 68
C 1005 N. GACEY Vol #: 68
C 1006 K. MCGRAW Vol #: 68
C 1007 K. HERBST Vol #: 68
C 1008 C. JARVIE Vol #: 68
C 1009 P. GEISER-DANLEY Vol #: 68
C 1010 N. BREITENFELD Vol #: 68
C 1011 B.ROBBINS Vol #: 68
C 1012 J. WATERLOW Vol #: 68
C 1013 B. SCHIANO Vol #: 68
C 1014 H. TUNGREN Vol #: 68
C 1015 S. SOMMER Vol #: 68
C 1016 S. ATKINS Vol #: 68
C 1017 A. SPENCER Vol #: 68
C 1018 T. TUDRON Vol #: 68
C 1019 D. SULLIVAN Vol #: 68
C 1020 M. BOOTH Vol #: 68
C 1021 L. MARINELLI Vol #: 68
EMC 360 D. Thompson Vol #: 5
EMC 361 N. Corsaro Vol #: 5
EMC 362 D. Gonsalves Vol #: 5
EMC 363 K. Walters Vol #: 5
EMC 364 M. Wood Vol #: 5
EMC 365 L. Clifford Vol #: 5
EMC 366 K. Allen Vol #: 5
EMC 367 L. Baur Vol #: 5
EMC 368 N. Brown Vol #: 5
EMC 369 B. Fletcher Vol #: 5
EMC 370 A. Cunningham Vol #: 5
EMC 371 J. Boyd Vol #: 5
EMC 372 K. Whitby Vol #: 5
EMC 373 S. Suzelis Vol #: 5
EMC 374 C. Capone Vol #: 5
EMC 375 A. Whitcomb Vol #: 5
EMC 376 F. Brant Vol #: 5
2004E-0019 Patent Extension, FUZEON (enfuvirtide), U.S. Patent No. 6,133,418
LET 5 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 2
2004E-0040 Patent Extension for CYDECTIN, U.S. Patent No. 4,916,154
LET 5 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
EMC 314 J. Sherrow Vol #: 36
EMC 315 D. & S. Briggs Vol #: 36
EMC 316 Hyman, Phelps & MacNamara, P. C. Vol #: 36
EMC 317 Gluten Intolerance Group of North America Vol #: 36
EMC 318 American Academy of Pediatrics Vol #: 36
2005N-0349 FDA Survey of Current Manufacturing Practices in the Food Industry
N 2 FDA Vol #: 1
2005N-0413 Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
EMC 12 A. Namaste Vol #: 2
EMC 13 D. Ward Vol #: 2
2005P-0459 To enforce ban on carbon monoxide gas in fresh meat packaging
EMC 15 A. Chen Vol #: 7
EMC 16 N. Odenweller Vol #: 7
2006D-0254 Guidance for Industry: Analytical Methods Description for Type C Medicated Feeds
GDL 2 Guidance Vol #: 1
NAD 2 FDA Vol #: 1
2006D-0363 Guidance for Industry and Food and Drug Administration Staff; Draft Class II Special Controls Guidance Document: Absorbable Hemostatic Device
NEC 1 FDA Vol #: 1
2006D-0441 Guidance for Industry: Protocols for the Conduct of Method Transfer Studies for Type C Medicated Feed Assay Methods
EMC 1 B. Sachau Vol #: 1
2006D-0480 Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
EC 132 Ms. Timothy Wright Vol #: 6
EC 133 Mrs. Carolyn Sisson Vol #: 6
EC 134 Mrs. Toni Knuth Vol #: 6
2006E-0031 Patent Extension Application for CLOLAR (clofarabine), U.S. Patent No. 5,661,136
LET 6 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006E-0033 Patent Extension Application for APTIVUS (tipranavir), U.S. Patent No. 5,852,195
LET 5 FDA/CDER to the U.S. Patent and Tradmark Office Vol #: 2
2006N-0362 General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
NEC 1 FDA Vol #: 1
2006N-0476 Drug Products Containing Quinine; Enforcement Action Dates
EMC 1 R. Rothman Vol #: 1
EMC 2 J. Welch Vol #: 1
EMC 3 R. & J. Siebert Vol #: 1
2007D-0027 Voluntary Self Inspection of Medicated Feed Manufacturing Facilities
NEC 1 FDA Vol #: 1
2007D-0117 Guidance for Industry on Orally Disintegrating Tablets
EMC 2 Exela Pharmsci Pvt., Ltd. Vol #: 1
2007D-0137 Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis
GDL 1 Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2007N-0051 Safety of Fresh Produce; Public Hearings
C 9 California Cantaloupe Advisory Board Vol #: 2
TS 6 Georogia Fruit and Vegetable Growers Association Vol #: 1
TS 7 California Farm Bureau Federation Vol #: 1
TS 8 Florida Tomato Exchange Vol #: 1
TS 9 Western Growers Association Vol #: 1
TS 10 Path Tracer Vol #: 1
TS 11 Food & Water Watch Vol #: 1
TS 12 Consumers Union Vol #: 1
TS 13 Owner-Operator Independent Drivers Association Vol #: 1
TS 14 New Jersey Department of Agriculture Vol #: 1
TS 15 International Irradiation Association and Food Irradiation Processors Alliance Vol #: 1
TS 16 Grocery Manufactureres/Food Products Association Vol #: 2
TS 17 Produce Marketing Association Vol #: 2
TS 18 FDA/CFSAN Vol #: 2
TS 19 Center for Science in the Publi Interest Vol #: 2
TS 20 FDA/CFSAN Vol #: 2
TS 21 FDA/CFSAN Vol #: 2
TS 22 FDA/CFSAN Vol #: 2
TS 23 Clemon University Vol #: 2
TS 24 Association of Food and Drug Officials (AFDO) Vol #: 2
TS 25 FDA/CFSAN Vol #: 2
TS 26 University of Florida Vol #: 2
TS 27 United Fresh Produce Association Vol #: 2
2007N-0121 Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
EAPE 155 Allen LaPointe, Nancy Vol #: 1
EAPE 156 Jones, Craig Vol #: 1
EAPE 157 Rohe, Paige Vol #: 1
EAPE 158 Ulrich, Linda Vol #: 1
EAPE 159 Kuhl, Mark Vol #: 1
EAPE 160 Johnson, Paul Vol #: 1
EAPE 161 Carson, Sandra Vol #: 1
EAPE 162 Lawlor, Tom Vol #: 1
EMC 11 A. Jorn Vol #: 2
EMC 12 D. Gallo Vol #: 2
EMC 13 M. Kuhn Vol #: 2
EMC 14 R. Swayze Vol #: 2
EMC 15 J. McCusker Vol #: 2
EMC 16 J. Holt Vol #: 2
EMC 17 L. Jamrozek Vol #: 2
EMC 18 Aurora Pharmacy, Inc. Vol #: 2
EMC 19 P. P. S. I. Vol #: 2
EMC 20 Corner Drug Vol #: 2
EMC 21 Corner Drug Vol #: 2
EMC 22 Richmond Apothecaries Vol #: 2
2007N-0136 Medical Devices; Immunology and Microbiology Devices; Classification of Gene Expression Profiling Test System for Breast Cancer Prognosis
NFR 1 FDA Vol #: 1
2007P-0085 Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
EMC 164 K. Spicer Vol #: 4
EMC 165 M. Reach Vol #: 4
EMC 166 P. Gray Vol #: 4
EMC 167 M. Davies Vol #: 4
EMC 168 F. Shecter Vol #: 4
EMC 169 E. Trill Vol #: 4
2007P-0093 Refuse to approve CIP-TRAMADOL ER until Cipher complies with the investigations Reports to show the safety and effectiveness of the drug
ACK 2 FDA/DDM to Kleinfeld, Kaplan and Becker, L.L.P. Vol #: 1
PSA 1 Purdue Pharma L.P. Vol #: 1
2007P-0127 Determine that any versions of tramadol for once-daily dosing will not be approved prior to expiration of three-year period of exclusivity for Ultram ER
ACK 2 FDA/DDM to Kleinfeld, Kaplan and Becker, L.L.P. Vol #: 1
PSA 1 Purdue Pharma L.P. Vol #: 1
2007P-0149 Canned Pacific Salmon Deviating From Identity Standard; Temporary Permit for Market Testing
EMC 1 B. Sachau Vol #: 1
2007P-0150 Iceberg Water Deviating From Identity Standard; Temporary Permit for Market Testing
EMC 1 B. Sachau Vol #: 1
2007P-0187 Requirements of Iodized Salt on Ingredient Labels
ACK 1 FDA / DDM to J Shingara Vol #: 1
CP 1 J Shingara Vol #: 1

Page created on May 9, 2007 ue

horizonal rule

Dockets Home| Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | A-Z Index | Contact FDA | Privacy | Accessibility

FDA/Dockets Management