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Dockets Management
Dockets Entered On September 28, 2004
Table of Contents
Docket # Title
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2001E-0032 Patent Extension for VISUDYNE, No. 5,095,030
2002E-0065 Patent Term Application for Kineret No. 5,075,222
2004D-0410 Application User Fees for Combination Products
2004D-0422 Guidance for Industry: Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA)
2004E-0023 Patent extension application 5,849,911 for Reyataz ( atazanavir sulfate )
2004E-0444 Patent Extension for BONIVA (ibandronate), U.S. Patent No. 4,927,814
2004E-0445 Patent Extension for HUMIRA (adalimumab), U.S. Patent No. 6,090,382
2004E-0446 Patent Extension Application for Sensipar (cinacalcet hydrochloride), U.S. Patent No. 6,011,068
2004N-0045 Agency Information Collection Activities: Proposed Collection; Comment Request; Health and Diet Survey b 2004 Supplement
2004N-0081 BSE Risk Materials in Foods and Cosmetics
2004N-0367 Cumulative List of Exceptions and Alternative Procedures
2004N-0423 Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 14506 Vita Pharmica, Inc. Vol #: 126
LET 14507 Vita Pharmica, Inc. Vol #: 126
LET 14508 Vita Pharmica, Inc. Vol #: 126
LET 14509 Nutritional Specialties, Inc. Vol #: 126
LET 14510 Tom's of Maine Vol #: 126
LET 14511 Enzymatic Therapy Vol #: 126
LET 14512 Enzymatic Therapy Vol #: 126
LET 14513 Synergy Worldwide Vol #: 126
LET 14514 AdvoCare International, L.P. Vol #: 126
LET 14515 AdvoCare International, L.P. Vol #: 126
LET 14516 Enzymatic Therapy Vol #: 127
LET 14517 Enzymatic Therapy Vol #: 127
LET 14518 Enzymatic Therapy Vol #: 127
LET 14519 Enzymatic Therapy Vol #: 127
LET 14520 Enzymatic Therapy Vol #: 127
LET 14521 Enzymatic Therapy Vol #: 127
LET 14522 Enzymatic Therapy Vol #: 127
LET 14523 Enzymatic Therapy Vol #: 127
LET 14524 Enzymatic Therapy Vol #: 127
LET 14525 Enzymatic Therapy Vol #: 127
LET 14526 Enzymatic Therapy Vol #: 127
LET 14527 Enzymatic Therapy Vol #: 127
LET 14528 Enzymatic Therapy Vol #: 127
LET 14529 Enzymatic Therapy Vol #: 127
LET 14530 Enzymatic Therapy Vol #: 127
LET 14531 Enzymatic Therapy Vol #: 127
LET 14532 Perrigo Company of South Carolina Vol #: 127
2001E-0032 Patent Extension for VISUDYNE, No. 5,095,030
N 1 FDA Vol #: 2
2002E-0065 Patent Term Application for Kineret No. 5,075,222
N 1 FDA Vol #: 1
2004D-0410 Application User Fees for Combination Products
GDL 1 Guidance Vol #: 1
NAL 1 FDA Vol #: 1
2004D-0422 Guidance for Industry: Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA)
GDL 1
Appendix
Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2004E-0023 Patent extension application 5,849,911 for Reyataz ( atazanavir sulfate )
N 1 FDA Vol #: 1
2004E-0444 Patent Extension for BONIVA (ibandronate), U.S. Patent No. 4,927,814
APP 1 Hoffman-La Roche Inc. Vol #: 1
LET 1 U.S. Patent & Trademark Office Vol #: 1
2004E-0445 Patent Extension for HUMIRA (adalimumab), U.S. Patent No. 6,090,382
APP 1 Abbott Laboratories Vol #: 1
LET 1 U.S. Patent & Trademark Office Vol #: 1
2004E-0446 Patent Extension Application for Sensipar (cinacalcet hydrochloride), U.S. Patent No. 6,011,068
APP 1 NPS Pharmaceticals Inc. and Brigham and Women's Hospital Vol #: 1
LET 1 U.S. Patent & Trademark Office Vol #: 1
2004N-0045 Agency Information Collection Activities: Proposed Collection; Comment Request; Health and Diet Survey b 2004 Supplement
NAL 1 FDA Vol #: 1
SS 1 Supporting Statement Vol #: 1
2004N-0081 BSE Risk Materials in Foods and Cosmetics
EMC 10 R and G Bonometti Vol #: 9
EMC 11 P. Toner Vol #: 9
EMC 12 No signature Vol #: 9
EMC 13 T. Shoemaker Vol #: 9
EMC 14 A. Martin Vol #: 9
EMC 15 D. Riemer Vol #: 9
EMC 16 D. Jessler Vol #: 9
EMC 17 J. Atkins Vol #: 9
EMC 18 L. Davis Vol #: 9
EMC 19 L. Bemis Vol #: 9
EMC 20 S. Cofresi Vol #: 9
EMC 21 M. Vizurraga Vol #: 9
EMC 22 L. Fahel Vol #: 9
EMC 23 S. Thalheimer Vol #: 9
EMC 24 J. Harker Vol #: 9
EMC 25 E. Dreele Vol #: 9
EMC 26 K. O'Neill Vol #: 9
EMC 27 Dr. & Mrs Nasif Vol #: 9
EMC 28 J. Boone Vol #: 9
EMC 29 WJ Geiger Vol #: 9
EMC 30 R. Rutkowski Vol #: 9
EMC 31 G. Reams Vol #: 9
EMC 32 K. Barton Vol #: 9
EMC 33 P. Persell Vol #: 9
EMC 34 M. Conradt Vol #: 9
EMC 35 K. Otero Vol #: 9
EMC 36 R. Savoie Vol #: 9
EMC 37 E.A. MacDonald Vol #: 9
EMC 38 D. Godin Vol #: 9
EMC 39 K. Himmer Vol #: 9
EMC 40 P. Allgood Vol #: 9
EMC 41 K Kirchdoerfer and D Baechle Vol #: 9
EMC 42 A. Morasca Vol #: 9
EMC 43 J. McLaren Vol #: 9
EMC 44 J. Barnett Vol #: 9
EMC 45 L. Scott Vol #: 9
EMC 46 K. Glauber Vol #: 9
EMC 47 No signature Vol #: 9
EMC 48 L. Pirretti Vol #: 9
EMC 49 L. Ostergaard Vol #: 9
EMC 50 B. Herner Vol #: 9
EMC 51 D. Matatyaho Vol #: 9
EMC 52 J. Clark Vol #: 9
EMC 53 N and G Shinn Vol #: 9
EMC 54 J. Coombs Vol #: 9
EMC 55 M. Azar Vol #: 9
EMC 56 W. Rozell Vol #: 9
EMC 57 L. McKnight Vol #: 9
EMC 58 A. Nessel Vol #: 9
EMC 59 J. French Vol #: 9
EMC 60 C. Engler Vol #: 9
EMC 61 R. Brislin Vol #: 9
EMC 62 C. MacNeil Vol #: 9
EMC 63 S. Thomas, PhD, M.S. Vol #: 9
EMC 64 N. Charcholla Vol #: 9
EMC 65 M. Hoffman Vol #: 9
EMC 66 R. Dellinger Vol #: 9
EMC 67 A. Nemirow Vol #: 9
EMC 68 R. Newman Vol #: 9
EMC 69 C. Lininger Vol #: 9
EMC 70 Dr. J. Bloom Vol #: 9
EMC 71 M. Lawrence Vol #: 9
EMC 72 C. Tavani,MD,MS,FAPA Vol #: 9
EMC 73 R. Riggs Vol #: 9
EMC 74 No signature Vol #: 9
EMC 75 S. Shaffer Vol #: 9
EMC 76 T. Allen Vol #: 9
EMC 77 The Brenner Family Vol #: 9
EMC 78 P. Becker Vol #: 9
EMC 79 T. Skaggs Vol #: 9
EMC 80 M. Alvarez Vol #: 9
EMC 81 J. Coker Vol #: 9
EMC 82 S. McCollum Vol #: 9
EMC 83 L. Lonsdale Vol #: 9
EMC 84 S. Dinh, Esq Vol #: 9
EMC 85 L. Howae Vol #: 9
EMC 86 R. Meltzer Vol #: 9
EMC 87 S. Aguero Vol #: 9
EMC 88 D. Lowis Vol #: 9
EMC 89 S. Heilemeier Vol #: 9
EMC 90 M. Nobile Vol #: 9
EMC 91 G. Clark Vol #: 9
EMC 92 G. Julian Vol #: 9
EMC 93 A. Stine Vol #: 9
EMC 94 G. Dunn Vol #: 9
EMC 95 C. and C. Lau Vol #: 9
EMC 96 No signature Vol #: 9
EMC 97 P. Salecki Vol #: 9
EMC 98 C. Bencze Vol #: 9
EMC 99 P. Williams Vol #: 9
EMC 100 S. Carr Vol #: 9
EMC 101 B. Walls Vol #: 9
EMC 102 E and D Pryor Vol #: 9
EMC 103 D. Selquist Vol #: 9
EMC 104 W. McMullin Vol #: 9
EMC 105 T. Rohrbacher Vol #: 9
EMC 106 C. Hritz Vol #: 9
EMC 107 K. Veen Vol #: 9
EMC 108 D. Damme, M.A. Vol #: 9
EMC 109 Kelly Vol #: 9
EMC 110 M. Jenkins Vol #: 9
EMC 111 A. Kelman Vol #: 9
EMC 112 B. Cornell Vol #: 9
EMC 113 M. Muynck Vol #: 9
EMC 114 T. Maryott Vol #: 9
EMC 115 S and P Teixeira Vol #: 9
EMC 116 E. Hall Vol #: 9
EMC 117 P. Hansen Vol #: 9
EMC 118 K. Hucks Vol #: 9
EMC 119 G. Kirk Vol #: 9
EMC 120 G. Carlsen Vol #: 9
EMC 121 D. Evans Vol #: 9
EMC 122 D. Getty Vol #: 9
EMC 123 V. Belt Vol #: 9
EMC 124 G. Sikes Vol #: 9
EMC 125 R. Anderlik Vol #: 9
EMC 126 L. Parker Vol #: 9
EMC 127 J. Roland Vol #: 9
EMC 128 T. Zausner Vol #: 9
EMC 129 E. Brandyberry Vol #: 9
EMC 130 A. Fortgang Vol #: 9
EMC 131 No signature Vol #: 9
EMC 132 E. Senyan Vol #: 9
EMC 133 K. Malley Vol #: 9
EMC 134 G. Koch Vol #: 9
EMC 135 C.J. Dupont Vol #: 9
EMC 136 No signature Vol #: 9
EMC 137 T. Wampler Vol #: 9
EMC 138 R. Glasser Vol #: 9
EMC 139 S. Reese Vol #: 9
EMC 140 V. Caracci Vol #: 9
EMC 141 J. Caracci Vol #: 9
EMC 142 J. Hughes Vol #: 9
EMC 143 Dr. L. Drager Vol #: 9
EMC 144 B. Matthes Vol #: 9
EMC 145 L. Seavert Vol #: 9
EMC 146 B. Redgrift Vol #: 9
EMC 147 A. Dehmer Vol #: 9
EMC 148 J. Caruk Vol #: 9
EMC 149 C. Biggerstaff Vol #: 9
EMC 150 J. Carter Vol #: 9
EMC 151 S. Segall Vol #: 9
EMC 152 K. Danahar Vol #: 9
EMC 153 C. Dewald Vol #: 9
EMC 154 D. Arias Vol #: 9
EMC 155 S. Collins Vol #: 9
EMC 156 No signature Vol #: 9
EMC 157 I. Cowan Vol #: 9
EMC 158 A. Dickie Vol #: 9
EMC 159 J. Janicki Vol #: 9
EMC 160 C. Hurtel Vol #: 9
EMC 161 L. Misirlic Vol #: 9
EMC 162 M. McKinney Vol #: 9
EMC 163 J. Kollenberg Vol #: 9
EMC 164 J. Blasingame Vol #: 9
EMC 165 D. Scott Vol #: 9
EMC 166 R. Sherman Vol #: 9
EMC 167 D. Alsheimer Vol #: 9
EMC 168 B. Sachau Vol #: 9
EMC 169 E. Walsh Vol #: 9
EMC 170 No signature Vol #: 9
EMC 171 E. Walsh Vol #: 9
EMC 172 G. Trost Vol #: 9
EMC 173 C. Jevic Vol #: 9
EMC 174 L. Brink Vol #: 9
EMC 175 M. Phillips Vol #: 9
EMC 176 Faith G. Vol #: 9
EMC 177 K. Smith Vol #: 9
EMC 178 C. Williams Vol #: 9
EMC 179 T. Sessions Vol #: 9
EMC 180 M. Eaves Vol #: 9
EMC 181 L and V Butler Vol #: 9
EMC 182 S. Hawkins Vol #: 9
EMC 183 F. Rogers Vol #: 9
EMC 184 S and R Hawkins Vol #: 9
EMC 185 C. Winchester Vol #: 9
EMC 186 J. Almy Vol #: 9
EMC 187 S. Fryer Vol #: 9
EMC 188 B. Wilson Vol #: 9
EMC 189 L. Patrizzi Vol #: 9
EMC 190 No signature Vol #: 9
EMC 191 M. and J. Gillono Vol #: 9
EMC 192 N. Bolten Vol #: 9
EMC 193 M. Cunningham Vol #: 9
EMC 194 J. Cielukowski Vol #: 9
EMC 195 S. Elliott Vol #: 9
EMC 196 K. Vayda Vol #: 9
EMC 197 S. Martin Vol #: 9
EMC 198 S. Etherton Vol #: 9
EMC 199 G. Werner Vol #: 9
EMC 200 M. Ericsen Vol #: 9
EMC 201 No signature Vol #: 9
EMC 202 No signature Vol #: 9
EMC 203 P. Cazier, MA Vol #: 9
EMC 204 J. Worl Vol #: 9
EMC 205 K. Ramakrishna, M.D. Vol #: 9
EMC 206 L. Cline Vol #: 9
EMC 207 M. Ericsen Vol #: 9
EMC 208 L. Meltz Vol #: 9
EMC 209 S. Mugford Vol #: 9
EMC 210 G. Zamboni Vol #: 9
EMC 211 B. Chin Vol #: 9
EMC 212 M. Lok Vol #: 9
EMC 213 D. Walsh Vol #: 9
EMC 214 S. Katz Vol #: 9
EMC 215 K. McCarthy Vol #: 9
EMC 216 B. Swaim Vol #: 9
EMC 217 K. Gander Vol #: 9
EMC 218 J. King Vol #: 9
EMC 219 K. Gander Vol #: 9
EMC 220 L. Logan Vol #: 9
EMC 221 L. Frenkel Vol #: 9
EMC 222 L. Whitehead Vol #: 9
EMC 223 A. Bates Vol #: 9
EMC 224 P. Welty Vol #: 9
EMC 225 D. Mensing Vol #: 9
EMC 226 M. Novita Vol #: 9
EMC 227 A.J. and C.A. Gaspero Vol #: 9
EMC 228 J. Frey Vol #: 9
EMC 229 L. Malcolmson Vol #: 9
EMC 230 K. Schatzmann Vol #: 9
EMC 231 C. Cording Vol #: 9
EMC 232 B. Staelens Vol #: 9
EMC 233 B. Staelens Vol #: 9
EMC 234 P. Maki Vol #: 9
EMC 235 J. Green Vol #: 9
EMC 236 S. McLean Vol #: 9
EMC 237 G. Ray Vol #: 9
EMC 238 M. DeLuca Vol #: 9
EMC 239 G. Ray Vol #: 9
EMC 240 J. Kehm Vol #: 9
EMC 241 E. Ferrari Vol #: 9
EMC 242 Dr. B. McKnight Vol #: 9
EMC 243 K. Malmquist Vol #: 9
EMC 244 M. Coffey Vol #: 9
EMC 245 A. Easley Vol #: 9
EMC 246 D. Appleton Vol #: 9
EMC 247 J. Oppenheim Vol #: 9
EMC 248 S. Cullen Vol #: 9
EMC 249 L. Chaoui Vol #: 9
EMC 250 F. Pisicoli Vol #: 9
EMC 251 M. Johnston Vol #: 9
EMC 252 B. Schrank Vol #: 9
EMC 253 L. Mandigo, PhD Vol #: 9
EMC 254 B. Canfield Vol #: 9
EMC 255 Mr and Mrs M Reed Vol #: 9
EMC 256 S. Wedge Vol #: 9
EMC 257 S. Longo Vol #: 9
EMC 258 L. Baumann Vol #: 9
EMC 259 Dr. D.K. and F.L. Cinquemani Vol #: 9
EMC 260 S ans A Nguyen Vol #: 9
EMC 261 E. Secrist Vol #: 9
EMC 262 Emerald DuCoeur Vol #: 9
EMC 263 E and L Fink Vol #: 9
EMC 264 P. Dunaway Vol #: 9
EMC 265 S. Goettsch Vol #: 9
EMC 266 T. Flowers Vol #: 9
EMC 267 M. Anderson Vol #: 9
EMC 268 M. Land Vol #: 9
EMC 269 D. Dove Vol #: 9
EMC 270 Yvonne Olsen Vol #: 9
EMC 271 E. Frappier Vol #: 9
EMC 272 A. Chappell Vol #: 9
EMC 273 No signature Vol #: 9
EMC 274 B. Holtz Vol #: 9
EMC 275 M. Girman Vol #: 9
EMC 276 E Waller Vol #: 9
EMC 277 No signature Vol #: 9
EMC 278 P. Packer Vol #: 9
EMC 279 S. Marchi Vol #: 9
2004N-0367 Cumulative List of Exceptions and Alternative Procedures
N 1 FDA Vol #: 1
2004N-0423 Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting
NM 1 FDA Vol #: 1
2004S-0212 Pandemic Influenza Preparedness and Response Plan
EC 4 Dr. Clara Witt Vol #: 1

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