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Dockets Management

Dockets Entered On February 27, 2007
Docket # Title
1995N-0220 Substances Appoved use in Preparation Meat/Poultry Products
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2001P-0230 Domestic Marketing & Importation of Transgenic Fish
2002N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
2003N-0573 Draft Animal Cloning Risk Assessment
2003P-0544 Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
2004E-0300 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,800,509
2004E-0301 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,891,190
2004E-0302 Patent Extenstion for S8 Over-the Wire System ( Driver Stent Delivery System), U.S. Patent No. 6,309,402
2004E-0303 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,879,382
2004E-0304 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,292,331
2004E-0306 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,836,965
2004E-0426 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,344,053
2004P-0262 Withdraw approval of ANDA suitability petition
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
2005N-0403 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2005P-0459 To enforce ban on carbon monoxide gas in fresh meat packaging
2006D-0383 Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
2006E-0206 Patent Extension Application for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,159,229
2006E-0261 Patent Extension Application for EXJADE (deferasirox), U.S. Patent No. 6,465,504
2006E-0355 Patent Extension Application for AMITIZA (lubiprostone), U.S. Patent No. 5,284,858
2006E-0356 Patent Extension Application for BARACLUDE (entecavir), U.S. Patent No. 5,206,244
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2006P-0410 Refuse to approve any ANDA for amifostine product with labeling which omits dosage and other information
2007N-0005 Prescription Drug User Fee Act (PDUFA): Public Meeting
2007V-0067 Laser Light Show
1995N-0220 Substances Appoved use in Preparation Meat/Poultry Products
NFR 2 FDA Vol #: 1
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 18942 Herbalist & Alchemist, Inc. Vol #: 171
LET 18943 Calgenex Corporation Vol #: 171
LET 18944 World Nutrition, Inc. Vol #: 171
LET 18945 Medtech Products, Inc. Vol #: 171
LET 18946 PuraPharm Corporation Vol #: 171
LET 18947 PuraPharm Corporation Vol #: 171
LET 18948 PuraPharm Corporation Vol #: 171
LET 18949 PuraPharm Corporation Vol #: 171
LET 18950 PuraPharm Corporation Vol #: 171
LET 18951 PuraPharm Corporation Vol #: 171
LET 18952 PuraPharm Corporation Vol #: 171
LET 18953 PuraPharm Corporation Vol #: 171
LET 18954 PuraPharm Corporation Vol #: 171
LET 18955 PuraPharm Corporation Vol #: 171
LET 18956 PuraPharm Corporation Vol #: 171
LET 18957 PuraPharm Corporation Vol #: 171
LET 18958 PuraPharm Corporation Vol #: 171
LET 18959 PuraPharm Corporation Vol #: 171
LET 18960 PuraPharm Corporation Vol #: 171
LET 18961 New Century Company Vol #: 171
LET 18962 Virginia Bionutrients, LLC Vol #: 171
LET 18963 Iovate Health Sciences U.S.A Inc. Vol #: 171
LET 18964 Iovate Health Sciences U.S.A Inc. Vol #: 171
LET 18965 Iovate Health Sciences U.S.A Inc. Vol #: 171
LET 18966 Iovate Health Sciences U.S.A Inc. Vol #: 171
LET 18967 Iovate Health Sciences U.S.A Inc. Vol #: 171
LET 18968 PuraPharm Corporation Vol #: 171
LET 18969 PuraPharm Corporation Vol #: 171
LET 18970 PuraPharm Corporation Vol #: 171
LET 18971 PuraPharm Corporation Vol #: 171
LET 18972 PuraPharm Corporation Vol #: 171
LET 18973 PuraPharm Corporation Vol #: 171
LET 18974 PuraPharm Corporation Vol #: 171
LET 18975 PuraPharm Corporation Vol #: 171
LET 18976 PuraPharm Corporation Vol #: 171
LET 18977 PuraPharm Corporation Vol #: 171
LET 18978 PuraPharm Corporation Vol #: 171
LET 18979 PuraPharm Corporation Vol #: 171
LET 18980 PuraPharm Corporation Vol #: 171
LET 18981 PuraPharm Corporation Vol #: 171
LET 18982 PuraPharm Corporation Vol #: 171
LET 18983 PuraPharm Corporation Vol #: 171
LET 18984 PuraPharm Corporation Vol #: 171
LET 18985 PuraPharm Corporation Vol #: 171
LET 18986 PuraPharm Corporation Vol #: 171
LET 18987 PuraPharm Corporation Vol #: 171
LET 18988 PuraPharm Corporation Vol #: 171
LET 18989 PuraPharm Corporation Vol #: 171
LET 18990 PuraPharm Corporation Vol #: 171
LET 18991 PuraPharm Corporation Vol #: 171
LET 18992 PuraPharm Corporation Vol #: 171
LET 18993 PuraPharm Corporation Vol #: 171
LET 18994 PuraPharm Corporation Vol #: 171
LET 18995 PuraPharm Corporation Vol #: 171
LET 18996 PuraPharm Corporation Vol #: 171
LET 18997 PuraPharm Corporation Vol #: 171
LET 18998 PuraPharm Corporation Vol #: 171
LET 18999 PuraPharm Corporation Vol #: 171
LET 19000 PuraPharm Corporation Vol #: 171
LET 19001 PuraPharm Corporation Vol #: 171
LET 19002 PuraPharm Corporation Vol #: 171
LET 19003 PuraPharm Corporation Vol #: 171
LET 19004 PuraPharm Corporation Vol #: 171
LET 19005 PuraPharm Corporation Vol #: 171
LET 19006 PuraPharm Corporation Vol #: 171
LET 19007 PuraPharm Corporation Vol #: 171
2001P-0230 Domestic Marketing & Importation of Transgenic Fish
C 1409 M. Chisnell Vol #: 262
2002N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
C 369 P. Dolinsky Vol #: 30
2003N-0573 Draft Animal Cloning Risk Assessment
C 184 J. Murray Vol #: 22
C 185 G. Tubridy Vol #: 22
C 186 D. Schrader Vol #: 22
C 187 J. Argyle Vol #: 22
C 188 M. Lucas Vol #: 22
C 189 A. McAbata Vol #: 22
C 190 S. Gregory Vol #: 22
C 191 S. Berridge Vol #: 22
C 192 J. Magee Vol #: 22
C 193 E. Snyder Vol #: 22
C 194 W. Zadan Vol #: 22
C 195 P. Nelson Vol #: 22
C 196 S. Farrell Vol #: 22
C 197 C. Ritch Vol #: 22
C 198 J. Brinckloe Vol #: 22
C 199 J. Bush Vol #: 22
C 200 F. Steel Vol #: 22
C 201 S. Willhite Vol #: 22
C 202 K. Waring Vol #: 22
C 203 W.Bolker Vol #: 22
C 204 B.Barr Vol #: 22
C 205 D. Dennenberg Vol #: 22
C 206 A. Chournard-Welk Vol #: 22
C 207 J. Speed Vol #: 22
C 208 J. Raview Vol #: 22
C 209 J. Perret Vol #: 22
C 210 E. Stuparyk Vol #: 22
C 211 B. Mikita Vol #: 22
C 212 P. Spigner Vol #: 22
C 213 J. Urbanik Vol #: 22
C 214 J. Convery Vol #: 22
C 215 J. Convery Vol #: 22
C 216 L. Bailly Vol #: 22
C 217 V. Girardi Jr Vol #: 22
C 218 L. Pierce Vol #: 22
C 219 A> Roche Vol #: 22
C 220 J. Homeister Vol #: 22
C 221 T. Ramsdell Vol #: 22
C 222 J. Arnold Vol #: 22
C 223 P. McHugh Vol #: 22
C 224 G. Vorhies Vol #: 22
EXT 1 H.Hellberg Vol #: 22
EXT 2 C. Waldrop Vol #: 22
EXT 3 R. Brillinger Vol #: 22
2003P-0544 Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
C 74 M. Chisnell Vol #: 5
2004E-0300 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,800,509
N 1 FDA Vol #: 1
2004E-0301 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,891,190
N 1 FDA Vol #: 1
2004E-0302 Patent Extenstion for S8 Over-the Wire System ( Driver Stent Delivery System), U.S. Patent No. 6,309,402
N 1 FDA Vol #: 1
2004E-0303 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,879,382
N 1 FDA Vol #: 1
2004E-0304 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,292,331
N 1 FDA Vol #: 1
2004E-0306 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,836,965
N 1 FDA Vol #: 1
2004E-0426 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,344,053
N 1 FDA Vol #: 1
2004P-0262 Withdraw approval of ANDA suitability petition
NWL 1 FDA Vol #: 1
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
C 675 J. Mellan Vol #: 32
C 676 A. Meyer Vol #: 32
C 677 B. Stewart Vol #: 32
C 678 C. Bonnie Vol #: 32
C 679 Cornell University Vol #: 32
C 680 J. Opatrny Vol #: 32
C 681 M. Freundlich Vol #: 32
C 682 R. Gilbert Vol #: 32
C 683 J. Lopez Vol #: 32
C 684 G. Opatrny Vol #: 32
C 685 J. Johnston Vol #: 32
EC 1646 Ms. Marya Bruning Vol #: 31
EC 1647 Mrs. Judy Pearson-Wright Vol #: 31
EC 1648 Ms. nina ferguson Vol #: 31
EC 1649 Alamo Celiac Vol #: 31
EC 1650 Ms. Diane Theuer Vol #: 31
EC 1651 Mrs. W Wiswell Vol #: 31
EC 1652 North Texas Gluten Intolerance Group Vol #: 31
EC 1653 Mrs. Tina Barad Vol #: 31
EC 1654 Celiac Awareness Vol #: 31
EC 1655 Mrs. Claire Fisher Vol #: 31
EC 1656 Ms. Lisa Licavoli Vol #: 31
EC 1657 Ms. Holly Schneider Vol #: 31
2005N-0403 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
EC 53 UCSD School of Medicine Vol #: 4
EC 54 FedEx Trade Networks Vol #: 4
EC 55 Ms. Jennifer Watson Vol #: 4
EC 56 City of Hope Vol #: 4
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
EC 33274 Mrs. Pamela Gore Vol #: 197
2005P-0459 To enforce ban on carbon monoxide gas in fresh meat packaging
C 13 Pactiv Corporation Vol #: 7
2006D-0383 Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
C 1592 E. Lum Vol #: 46
C 1593 J. Davis Vol #: 46
C 1594 C. Knop Vol #: 46
C 1595 J. Manidis Vol #: 46
C 1596 T. Manidis Vol #: 46
C 1597 S. Canady Vol #: 46
C 1598 J. Benrich Vol #: 46
C 1599 E. & R. Spaeth Vol #: 46
2006E-0206 Patent Extension Application for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,159,229
N 1 FDA Vol #: 1
2006E-0261 Patent Extension Application for EXJADE (deferasirox), U.S. Patent No. 6,465,504
N 1 FDA Vol #: 1
2006E-0355 Patent Extension Application for AMITIZA (lubiprostone), U.S. Patent No. 5,284,858
N 1 FDA Vol #: 1
2006E-0356 Patent Extension Application for BARACLUDE (entecavir), U.S. Patent No. 5,206,244
N 1 FDA Vol #: 1
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
LET 10 FDA to Honorable Dennis Moore, U.S. House of Representatives Vol #: 36
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 57 N. Jones Vol #: 6
C 58 C. Whitaub Vol #: 6
C 59 M. Carter Vol #: 6
C 60 P. Bertsch Vol #: 6
2006P-0410 Refuse to approve any ANDA for amifostine product with labeling which omits dosage and other information
C 4 Sun Pharmaceutical Industries, Ltd. Vol #: 1
2007N-0005 Prescription Drug User Fee Act (PDUFA): Public Meeting
C 2 Sepracor Vol #: 2
2007V-0067 Laser Light Show
ACK 1 FDA / DDM to Aqua Night Club Vol #: 1
VAR 1 Aqua Night Club Vol #: 1

Page created on February 28, 2007 ue

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