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Dockets Entered On November 29, 2006
Docket # Title
1978N-0065 Skin Bleaching Drug Products
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
2003P-0544 Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
2005D-0310 Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events
2005N-0097 Agency Information Collection Activities: Proposed Collection; Comment Request;
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
2006D-0331 Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
2006D-0336 Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
2006D-0344 Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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-0478 Patent Extension Application for NovoLog insulin aspart (rDNA origin) injection, U.S. Patent No. 5,618,913
2006N-0335 Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
2006N-0414 Suicidality Data from Adult Antidepressant Trials
2006N-0452 Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization
2006N-0465 Improving Patient Safety by Enhancing the Container Labeling for Parenteral Infusion Drug Products; Public Meeting
2006N-0468 Training Program for Regulatory Project Managers; Information Available to Industry
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2006P-0481 ANDA Suitability for Oxycodone Hydrochloride Capsules, 5 mg
2006P-0484 Change the indication for Stimulant Medications for the Treatment of Mental Diseases
2006V-0482 Laser Light Show
1978N-0065 Skin Bleaching Drug Products
C 42 Gundersen Lutheran Clinic, Ltd Vol #: 15
EC 99 Mayo Clinic Vol #: 14
EC 100 Dr. Kris Howard Vol #: 14
EC 101 Dr. Dorota Wilson Vol #: 14
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 742 Calorie Control Council Vol #: 10
EMC 743 Calorie Control Council Vol #: 10
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 1388 K. White Vol #: 12
2003P-0544 Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
C 70 L. Husted Vol #: 5
2005D-0310 Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events
GDL 2 Guidance Vol #: 1
NAD 2 FDA Vol #: 1
2005N-0097 Agency Information Collection Activities: Proposed Collection; Comment Request;
NAL 1 FDA Vol #: 1
SS 1 Supporting Statement Vol #: 1
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
EMC 4
Attachment
National Institute of Standards & Technology | China Vol #: 4
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
EMC 4154 C. Marsh Vol #: 195
EMC 4155 L. Paolilli Vol #: 195
EMC 4156 L. Apatini Vol #: 195
2006D-0331 Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
C 12 American Brain Injury Consortium Vol #: 3
EMC 5 N. I. H.-Office of Biotechnology Activities-Office of Science Policy-Office of the Director Vol #: 3
2006D-0336 Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
NEC 1 FDA Vol #: 1
2006D-0344 Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
C 10 Boehringer-Ingelheim Pharmaceuticals Vol #: 1
2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
NEC 1 FDA Vol #: 1
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 136 B. McDonnell Vol #: 9
C 137 J and H Costello Vol #: 9
C 138 J. Gaes Vol #: 9
C 139 D. Parry MA, CChem, MRSC, dip lib, MCLIP Vol #: 9
C 140 C. Angelo Vol #: 9
C 141 M. Sickels Vol #: 9
C 142 M. Webster Vol #: 9
C 143 T. Capano Vol #: 9
C 144 A. Springer Vol #: 9
C 145 S. Stewart Vol #: 9
C 146 D. Jabaley Vol #: 9
C 147 W. and C Yontz Vol #: 9
C 148 E. Mohler Vol #: 9
C 149 L. Sosa Vol #: 9
C 150 D. Laurens, M.A. Vol #: 9
C 151 K. Kremer Vol #: 9
C 152 M and T Ruppert Vol #: 9
C 153 W. Murphy Vol #: 9
C 154 C. Flugel Vol #: 9
C 155 M. Brazwell Vol #: 9
C 156 J. Muller Vol #: 9
C 157 A. Popiel Vol #: 9
C 158 P. Pokorny Vol #: 9
EC 2254 Mr. Robert Stein Vol #: 8
EC 2255 Mr. Brian/Shawna Harrington Vol #: 8
EC 2256 Mrs. Christine Case Vol #: 8
EC 2257 Dr. MaryTim Baggott Vol #: 8
EC 2258 Mr. Thomas Lindley Vol #: 8
EC 2259 Mr. Eric Fedewa Vol #: 8
EC 2260 Mrs. Alice Shelton Vol #: 8
EC 2261 Life Matters Vol #: 8
EC 2262 Mrs. Della Schoenecker Vol #: 8
EC 2263 Mrs. Angela Anderson Vol #: 8
EC 2264 Comsumer Group (Catholic) Vol #: 8
EC 2265 Mrs. Suzanne Kobzdej Vol #: 8
EC 2266 Mrs. Joan Hephner Vol #: 8
EC 2267 Ms. Judith Hankel, Caregiver Vol #: 8
EC 2268 Mrs. Monica Mountain Vol #: 8
EC 2269 Mrs. Michelle Lynch Vol #: 8
EC 2270 Mrs. Carol Lyvers Vol #: 8
EC 2271 Mr. Charles Mosco Vol #: 8
EC 2272 Mrs. Elizabeth Ortega Vol #: 8
EC 2273 Mrs. Laura Quesenberry Vol #: 8
EC 2274 Mr. Steven Henstebeck Vol #: 8
EC 2275 Mrs. Cheryl Waguespack Vol #: 8
EC 2276 Mr. Dan Brown Vol #: 8
EC 2277 Mrs. Betsy Kerekes Vol #: 8
EC 2278 Mrs. Elizabeth Larson Vol #: 8
EC 2279 Ms. Jennifer Lawler Vol #: 8
EC 2280 Mr. Don Demas Vol #: 8
EC 2281 Dr. Michele Hedspeth Vol #: 8
EC 2282 Mrs. Jennifer Reesman Vol #: 8
EC 2283 Mrs. Laurel Gorney Vol #: 8
EC 2284 Mrs. colleen milz Vol #: 8
EC 2285 Mrs. Nancy Payton Vol #: 8
EC 2286 Miss. Susan Gustavson Vol #: 8
EC 2287 Dr. AiXuan Holterman Vol #: 8
EC 2288 Mrs. Lavona Rann Vol #: 8
EC 2289 Ms. Rhonda L Mannino Vol #: 8
EC 2290 Mrs. Brenda Beverly Vol #: 8
EC 2291 Ms. Donna Kisel, RN-CAPA Vol #: 8
EC 2292 Mrs. Christina Durnil Vol #: 8
EC 2293 Mr. Thomas Chelak Vol #: 8
EC 2294 Mr. Tim Heeren Vol #: 8
EC 2295 Mrs. Carol Alvarado Vol #: 8
EC 2296 Mr. David Trask Vol #: 8
EC 2297 Mr. Joseph Santucci Vol #: 8
EC 2298 Mr. JOHN ALVARADO Vol #: 8
EC 2299 Mrs. Elizabeth Skrzynecka-Carlos Vol #: 8
EC 2300 none Vol #: 8
EC 2301 Mrs. Teresa Geoffroy Vol #: 8
EC 2302 Mr. David Mack Vol #: 8
EC 2303 Mr. Steve Hamilton Vol #: 8
EC 2304 Mr. Pablo Dominguez Vol #: 8
EC 2305 Mr. Joseph Crnkovich Vol #: 8
EC 2306 Mr. Robert Colon Vol #: 8
EC 2307 Mr. james l. barnes Vol #: 8
EC 2308 Ms. joyce brady Vol #: 8
EC 2309 Mrs. Brenda Kolic Vol #: 8
EC 2310 Mrs. Bridget Helm Vol #: 8
EC 2311 Mrs. Penny Mallo Vol #: 8
EC 2312 Dr. Elizabeth Berger Vol #: 8
EC 2313 Mr. Tom Nathe Vol #: 8
EC 2314 Ms. Mary Moroney Vol #: 8
EC 2315 Mrs. Geraldine Korman Vol #: 8
EC 2316 Mr. Gregory Tashjian Vol #: 8
EC 2317 Mr. Don Ross Vol #: 8
EC 2318 Mr. CHARLES DEREUIL Vol #: 8
EC 2319 Mr. Ralph Colucci Vol #: 8
EC 2320 Mr. Mark Lysecky Vol #: 8
EC 2321 Mrs. Wanda Formentini Vol #: 8
EC 2322 Mr. Philip Hesselbein Vol #: 8
EC 2323 Mrs. Elizabeth Logan Vol #: 8
EC 2324 Mrs. Jennifer Schuler Vol #: 8
EC 2325 Mrs. Patricia Katagiri Vol #: 8
EC 2326 Citizens for a Pro-Life Society-WI Vol #: 8
EC 2327 Mrs. Kara Coleman Vol #: 8
EC 2328 Mrs. suzanne brixius Vol #: 8
EC 2329 Mr. Chris Donatto Vol #: 8
2006E-0478 Patent Extension Application for NovoLog insulin aspart (rDNA origin) injection, U.S. Patent No. 5,618,913
APP 1 Novo Nordisk Inc. Vol #: 1
LET 1 U.S. Patent and Trademark Office to FDA/CDER Vol #: 1
LET 2 U.S. Patent and Trademark Office to Novo Nordisk Inc. Vol #: 1
2006N-0335 Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of
EC 1 Mr. michael nichols Vol #: 1
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
C 562 V. Walton Vol #: 27
C 563 J. Mines Vol #: 27
C 564 R. Wilson Vol #: 27
C 565 J. Schaefer Vol #: 27
C 566 D. NAdeau Vol #: 27
C 567 L. Porter Vol #: 27
C 568 L and J Warren Vol #: 27
C 569 T. Paolucci Vol #: 27
C 570 B. Silverman Vol #: 27
C 571 C. Neurath Vol #: 27
C 572 V. Barber Vol #: 27
C 573 M. Yates Vol #: 27
C 574 K. Douglas Vol #: 27
C 575 J. Stromseth Vol #: 27
C 576 L. Fettig Vol #: 27
C 577 K. Yagemann Vol #: 27
C 578 J. Short, DDS, MSc, DIHom Vol #: 27
C 579 J. Ebbott Vol #: 27
C 580 T. White Vol #: 27
C 581 H and V Distad Vol #: 27
C 582 D. Johnson Vol #: 27
C 583 C. Verge Vol #: 27
C 584 Arizona Homeopathic and Integrative Medical Association Vol #: 27
C 585 C. Spencer Vol #: 27
C 586 A. North Vol #: 27
C 587 L. Henderson Vol #: 27
C 588 Dr. P. Connett Vol #: 27
C 589 C. Gerardi, EdM Vol #: 27
C 590 G. Maguire Vol #: 27
C 591 J. Palombo Vol #: 27
C 592 Dr. B. Lafferty Vol #: 27
C 593 J. Kelleher, PhD Vol #: 27
C 594 Dr. K. Anderson, DDS, MS Vol #: 27
C 595 M. Webster Vol #: 27
C 596 O. Duke Vol #: 27
C 597 J. Klein Vol #: 27
C 598 J. Johnson Vol #: 27
C 599 R. Kennedy, MD Vol #: 27
C 600 J. Means Vol #: 27
C 601 J. Gleiter Vol #: 27
C 602 Aesthetic Dentistry of Bellevue Vol #: 27
C 603 K. Jones, PhD Vol #: 27
C 604 K. Trammel Vol #: 27
C 605 D. Pence, DDS Vol #: 27
C 606 Santa Monicans for Safe Drinking Water Coalition Vol #: 27
C 607 P. Wheeldon Vol #: 27
C 608 J. Zwaal Vol #: 27
C 609 D. Burstrom Vol #: 27
C 610 H. Berlin, DDS Vol #: 27
C 611 B. Weatherbee Vol #: 27
C 612 S. Williams Vol #: 27
C 613 C. Gochenour Vol #: 27
C 614 S. Holmstrom Vol #: 27
C 615 D. Temple Vol #: 27
C 616 L. Quayle Vol #: 27
C 617 B. Hiley Vol #: 27
C 618 C. McMillan Vol #: 27
C 619 Consumers for Dental Choice Vol #: 27
C 620 J. Frazel Vol #: 27
C 621 K. Scott, MS Vol #: 27
C 622 R. Schmidt, D.O. Vol #: 27
C 623 L. Williamson Vol #: 27
C 624 No signature Vol #: 27
C 625 D. Manning Vol #: 27
C 626 R. Milligan Vol #: 27
C 627 J. HAusmann Vol #: 27
C 628 M. Wyhe Vol #: 27
EMC 1148 B. Segali Vol #: 24
EMC 1149 M. Cox Vol #: 24
2006N-0414 Suicidality Data from Adult Antidepressant Trials
EC 13 Mr. Frazer Merritt Vol #: 1
EC 14 Mrs. Rosie Meysenburg Vol #: 1
2006N-0452 Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization
EC 1 Mr. Paul Meixner Vol #: 1
EC 2 Mrs. Norene Fields Vol #: 1
EC 3 Mr. Walter Copp Vol #: 1
EC 4 Mr. michael nichols Vol #: 1
2006N-0465 Improving Patient Safety by Enhancing the Container Labeling for Parenteral Infusion Drug Products; Public Meeting
NM 1 FDA Vol #: 1
2006N-0468 Training Program for Regulatory Project Managers; Information Available to Industry
N 1 FDA Vol #: 1
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 22 J. Shannon Vol #: 6
EC 430 Miss. Barbara Pfouts Vol #: 7
2006P-0481 ANDA Suitability for Oxycodone Hydrochloride Capsules, 5 mg
ACK 1 FDA/DDM to Actavis Totowa, LLC Vol #: 1
CP 1 Actavis Totowa, LLC Vol #: 1
2006P-0484 Change the indication for Stimulant Medications for the Treatment of Mental Diseases
ACK 1 FDA/DDM to M. McDole Vol #: 1
CP 1 M. McDole Vol #: 1
2006V-0482 Laser Light Show
ACK 1 FDA / DDM to Griffin Behm Vol #: 1
VAR 1 Griffin Behm Vol #: 1

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