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Dockets Management

Dockets Entered On October 22, 2007
Docket # Title
1978N-0038 Sunscreen Drug Products
1995S-0316 75-Day Premarket Notifications for New Dietary Ingredients
2006P-0158 Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2006P-0415 Petition Seeking Regulation of Cloned Animals
2006P-0508 Make 2 to 5 milligram pills of Naltrexone to have over-the-counter status
2007D-0249 Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage
2007D-0388 Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protec
2007N-0321 Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct
2007N-0347 Information Technology Strategic Planning; Public Meeting
2007N-0356 BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
2007N-0357 Medical Device User Fee and Modernization Act; Notice to Public of Web Location of 2008 Proposed Guidance Development; Establishment of a Public Docket.
2007P-0074 Over-the-Counter (OTC) Cough and Cold Drug Products for Children Under 6 Years of Age
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-0158 Patent Listing and Market Exclusivity for Combination Drugs When One Component is a pre-1997 Antibiotic Ingredient
2007P-0210 Reclassification Petition for Human Papillomavirus (HPV) DNA Nested Polymerase Chain Reaction (PCR) Detection under Section 513(f), 21 CFR 860 Subpart C
2007P-0235 Change the labeling requirements for eggs sold in the United States
2007P-0320 Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
2007P-0404 Declare that Cefixime for Oral Suspension, 100 mg/mL, is suitable for submission as an ANDA
2007P-0405 Stay the effective date of any possible refusal of entry AQZ-0251621-2
1978N-0038 Sunscreen Drug Products
EC 2461 Mr. Todd Miller Vol #: 161
EC 2462 University of California, Berkeley School of Law Vol #: 161
EREG 5 J. Kidd Vol #: 162
EREG 6 C. McDermott Vol #: 162
1995S-0316 75-Day Premarket Notifications for New Dietary Ingredients
RPT 413 KSB Group Corp Vol #: 325
RPT 414 Gold Leaf Sustainable Vol #: 325
RPT 415 Marlyn Nautriceuticals, LLC Vol #: 328
2006P-0158 Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
C 1 Deb Shore Vol #: 1
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 396 S. Rojze Vol #: 12
C 397 D. Bedlin Vol #: 12
C 398 S. Dias Vol #: 12
C 399 D. Frasz Vol #: 12
C 400 L. Noel & C. Cusumano Vol #: 12
C 401 M. Robinson Vol #: 12
C 402 Q. Huckeby Vol #: 12
C 403 S. Strovi Vol #: 12
C 404 Unknown Vol #: 12
C 405 S. M. Peckham Vol #: 12
C 406 E. Huibregdse Vol #: 12
C 407 M. Beckwith Vol #: 12
C 408 A. Tyler Vol #: 12
C 409 J. Steinberg Vol #: 12
C 410 J. Robbins Vol #: 12
C 411 S. Vania Vol #: 12
C 412 M. Roy Vol #: 12
C 413 E. Norton Vol #: 12
C 414 F. Odabers-Geldiay Vol #: 12
C 415 F. Smith Vol #: 12
C 416 R. Thompson Vol #: 12
C 417 M. Carpenter Vol #: 12
C 418 Unknown Vol #: 12
C 419 K. Sadeem Vol #: 12
C 420 C. Oleva Vol #: 12
C 421 R. Keirn Vol #: 12
C 422 D. Molore Vol #: 12
C 423 P. Fredericks Vol #: 12
C 424 L. Texcina Vol #: 12
C 425 C. Coraett Vol #: 12
C 426 A. Robb Vol #: 12
C 427 M. Neese Vol #: 12
C 428 J. Mantooth Vol #: 12
C 429 L. Wapner Vol #: 12
C 430 Unknown Vol #: 12
C 431 M. Kagy Vol #: 12
C 432 B. Burns Vol #: 12
C 433 W. Wilson Vol #: 12
C 434 E. Schoefer Vol #: 12
2006P-0415 Petition Seeking Regulation of Cloned Animals
C 60 Merrill Kramer Vol #: 6
2006P-0508 Make 2 to 5 milligram pills of Naltrexone to have over-the-counter status
PDN 1 Janet Woodcock Vol #: 1
2007D-0249 Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage
C 5 Pfizer Vol #: 1
2007D-0388 Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protec
EC 1 Childrens National Medical Center Vol #: 1
2007N-0321 Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct
EC 16 AstraZeneca LP Vol #: 1
EC 17 Prescription Access Litigation & 26 others Vol #: 1
EC 18 sanofi-aventis Vol #: 1
EC 19 Merck Research Laboratories Vol #: 1
EC 20 Stanford University Vol #: 1
EC 21 Ms. Wanda Jones Vol #: 1
EC 22 American Academy of Pediatrics Vol #: 1
2007N-0347 Information Technology Strategic Planning; Public Meeting
EC 13 Keane, Inc. Vol #: 1
2007N-0356 Behind The Counter Availability of Certain Drugs; Public Meeting
EAPE 150 Former FDA Vol #: 1
EAPE 151 Institute for Public Health and Pharmacy Vol #: 1
EAPE 152 National Women's Health Network Vol #: 1
EAPE 153 Johnson & Johnson Vol #: 1
EAPE 154 Wyeth Pharmaceuticals Vol #: 1
EAPE 155 Hellebusch Research & Consulting, Inc. Vol #: 1
EAPE 156 Medco Vol #: 1
EAPE 157 Medco Vol #: 1
EAPE 158 Johnson & Johnson Vol #: 1
EAPE 159 Johnson & Johnson Vol #: 1
EAPE 160 Medco Vol #: 1
EAPE 161 test Vol #: 1
2007N-0357 Medical Device User Fee and Modernization Act; Notice to Public of Web Location of 2008 Proposed Guidance Development; Establishment of a Public Docket.
LET 1 Clinical Trials Group Roche Diagnostics Vol #: 1
2007P-0074 Over-the-Counter (OTC) Cough and Cold Drug Products for Children Under 6 Years of Age
EC 11 Mr. Darrin McQuay Vol #: 1
EC 12 Mrs. Leah Shannon Vol #: 1
EC 13 Ms. Marge Yuenger Vol #: 1
EC 14 Dr. Jennifer Hamilton Vol #: 1
EC 15 Mr. Andrew Eckhardt Vol #: 1
EC 16 Mrs. Deidre Daigle 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
C 346 G. M. Yaport Vol #: 6
2007P-0158 Patent Listing and Market Exclusivity for Combination Drugs When One Component is a pre-1997 Antibiotic Ingredient
LET 1 Jane A. Axelrad Vol #: 1
2007P-0210 Reclassification Petition for Human Papillomavirus (HPV) DNA Nested Polymerase Chain Reaction (PCR) Detection under Section 513(f), 21 CFR 860 Subpart C
LET 1 HiFi DNA Vol #: 5
2007P-0235 Change the labeling requirements for eggs sold in the United States
C 153 J. Steinberg Vol #: 2
C 154 J. Robbins Vol #: 2
C 155 S. Vania Vol #: 2
C 156 M. Roy Vol #: 2
C 157 E. Norton Vol #: 2
C 158 F. Odabers-Geldiay Vol #: 2
C 159 F. Smith Vol #: 2
C 160 R. Thompson Vol #: 2
C 161 M. Carpenter Vol #: 2
C 162 Unknown Vol #: 2
C 163 K. Sadeem Vol #: 2
C 164 C. Oleva Vol #: 2
C 165 R. Keirn Vol #: 2
C 166 D. Malore Vol #: 2
C 167 P. Fredericks Vol #: 2
C 168 L. Texeina Vol #: 2
C 169 S. Rojis Vol #: 2
C 170 D. Bedlin Vol #: 2
C 171 S. Dias Vol #: 2
C 172 D. Frasz Vol #: 2
C 173 L. Noel & C. Cusumano Vol #: 2
C 174 M. Robinson Vol #: 2
C 175 Q. Hickeby Vol #: 2
C 176 S. Ostrovi Vol #: 2
C 177 Unknown Vol #: 2
C 178 S. M. Peckham Vol #: 2
C 179 E. Huibregdse Vol #: 2
C 180 M. Beckwith Vol #: 2
C 181 A. Tyler Vol #: 2
C 182 C. A. Tyler Vol #: 2
C 183 Z. Dever Vol #: 2
C 184 L Byrne Vol #: 2
C 185 E. Pleman Vol #: 2
C 186 I Drake Vol #: 2
C 187 L. Parker Vol #: 2
C 188 S. Vanduier Vol #: 2
C 189 P. B. Lynch Vol #: 2
C 190 S. Harkim Vol #: 2
C 191 Unknown Vol #: 2
C 192 A. Joze Vol #: 2
C 193 K. Bellmey Vol #: 2
C 194 A. Erjy Vol #: 2
C 195 C. Hines Vol #: 2
C 196 V. Ober Vol #: 2
C 197 S. Luke Vol #: 2
C 198 M. Ochal Vol #: 2
2007P-0320 Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
EC 15 Miss. Nicole Lacy Vol #: 1
EC 16 Mr. Sergei Matsevich Vol #: 1
2007P-0404 Declare that Cefixime for Oral Suspension, 100 mg/mL, is suitable for submission as an ANDA
ACK 1 FDA/DDM to Lupin Pharmaceuticals, Inc. Vol #: 1
CP 1 Lupin Pharmaceuticals, Inc. Vol #: 1
2007P-0405 Stay the effective date of any possible refusal of entry AQZ-0251621-2
ACK 1 FDA/DDM to Fuerst, Humphrey, Ittleman, PL Vol #: 1
PSA 1 Thunder Bay Seafood Company Vol #: 1

Page created on October 22, 2007 ue

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