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Dockets Management
Dockets Entered On September 17, 2004
Table of Contents
Docket # Title
1976N-0052N OTC Nasal Decongestants
1981N-0022 OTC Weight Control Drug Products for Human Use
1981N-0033 Oral Health Care Drug Products for OTC Human Use
1994P-0390 Adopt Amendments Governing Health Claims & Nutrient Claims
1995P-0241 Implied Nutrient Content Claim 'Healthy' & Health Claims
1999P-2630 Establish a Daily Value for "added sugars"
1999P-5106 Identify Sources of Natural Flavorings
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
2002D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
2002P-0317 Recall Aspartame as a Neurotoxic Drug
2003M-0172 PMA Cypher Sirolimus-Eluting Coronary Stent on the Raptor
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2003N-0169 Dental Amalgam; Request for Information
2003N-0312 Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
2003N-0455 Training Program for Regulatory Project Managers; Information Available to Industry
2004D-0193 Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
2004E-0425 Patent Extension for Plenaxis (abarelix), U.S. Patent No. 5,843,901
2004E-0426 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,344,053
2004E-0427 Patent Extension for Ketek (telithromycin), U.S. Patent No. 5,635,485
2004H-0322 Civil Money Penalty Re: Ecumed Health Group, Inc.
2004N-0018 Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
2004N-0081 BSE Risk Materials in Foods and Cosmetics
2004N-0214 Public Information Regulations
2004N-0230 Food; Current Good Manufacturing Practice Regulations; Public Meetings
2004N-0264 Federal Measures to Mitigate BSE Risks: Considerations for Further Action
2004N-0330 Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
2004V-0424 Laser Light Show
1976N-0052N OTC Nasal Decongestants
M 1 Public Health Advisory; Safety of Phenylpropanolamine Vol #: 77
1981N-0022 OTC Weight Control Drug Products for Human Use
M 7 Public Health Advisory; Safety of Phenylpropanolamine Vol #: 95
1981N-0033 Oral Health Care Drug Products for OTC Human Use
SUP 8 Dyclo9, Inc. Vol #: 72
1994P-0390 Adopt Amendments Governing Health Claims & Nutrient Claims
EMC 8 International Dairy Foods Assn (IDFA) Vol #: 7
1995P-0241 Implied Nutrient Content Claim 'Healthy' & Health Claims
EMC 8 International Dairy Foods Assn (IDFA) Vol #: 9
1999P-2630 Establish a Daily Value for "added sugars"
EMC 795 A. Marvin Vol #: 33
EMC 796 S. Swanson Vol #: 33
1999P-5106 Identify Sources of Natural Flavorings
EMC 206 M. Bonazzoli Vol #: 3
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
EMC 10310 E. Edenfield Vol #: 287
EMC 10311 T. Thompson Vol #: 287
EMC 10312 C. Prevosto Vol #: 287
EMC 10313 Erin Vol #: 287
EMC 10314 G. Cheeseman Vol #: 287
EMC 10315 D. Hanlon Vol #: 287
EMC 10316 J. Castro Vol #: 287
EMC 10317 K. Biesenbach Vol #: 287
EMC 10318 M. Casino Vol #: 287
EMC 10319 J. Thompson Vol #: 287
EMC 10320 K. Mackey Vol #: 287
EMC 10321 J. Gilles Vol #: 287
EMC 10322 D. Erickson Vol #: 287
EMC 10323 S. Roberson Vol #: 287
EMC 10324 S. Roberson Vol #: 287
EMC 10325 R. Redtail Vol #: 287
EMC 10326 L. Stuparitz Vol #: 287
EMC 10327 S. Pederson Vol #: 287
EMC 10328 A. Smith Vol #: 287
EMC 10329 J. Salomon Vol #: 287
EMC 10330 R. Dennis Vol #: 287
EMC 10331 T. Reynolds Vol #: 287
EMC 10332 T. Reynolds Vol #: 287
EMC 10333 S. Lintott Vol #: 287
EMC 10334 K. Dague Vol #: 287
EMC 10335 C. Howard Vol #: 287
EMC 10336 J. Collings, MD Vol #: 287
EMC 10337 L. Hibberts Vol #: 287
EMC 10338 K. Anderson Vol #: 287
EMC 10339 N. Wallin Vol #: 287
EMC 10340 J. Kennedy Vol #: 287
EMC 10341 C. Hembd Vol #: 287
EMC 10342 V. Jackson Vol #: 287
EMC 10343 M. Nolan Vol #: 287
EMC 10344 J. Londrigan Vol #: 287
EMC 10345 K. Kennedy Vol #: 287
EMC 10346 M. Stacy Vol #: 287
EMC 10347 B. Milby Vol #: 287
EMC 10348 B. Milby Vol #: 287
EMC 10349 G. Floren Vol #: 287
EMC 10350 T. Widger Vol #: 287
EMC 10351 M. Klein Vol #: 287
EMC 10352 A. Langley Vol #: 287
EMC 10353 Y. Zimmerman Vol #: 287
EMC 10354 D. Eades Vol #: 287
EMC 10355 H. Baburek Vol #: 287
EMC 10356 L. Brognano Vol #: 287
EMC 10357 M. Gunatilleke Vol #: 287
EMC 10358 C. Nussbaum Vol #: 287
EMC 10359 K. Smith Vol #: 287
EMC 10360 Inna K. Vol #: 287
EMC 10361 L. Pietroniro Vol #: 287
EMC 10362 L. Jackson Vol #: 287
EMC 10363 A. Hurley Vol #: 287
EMC 10364 A. Hurley Vol #: 287
EMC 10365 L. Hughes Vol #: 287
EMC 10366 E. Cotterman Vol #: 287
EMC 10367 S. Shepard Vol #: 297
EMC 10368 J. Thomas Vol #: 287
EMC 10369 L. Lewis Vol #: 287
EMC 10370 K. McAbee Vol #: 287
EMC 10371 L. Lewis Vol #: 287
EMC 10372 N. Anderson Vol #: 287
EMC 10373 K. Okuda Vol #: 287
EMC 10374 J. Laidlaw Vol #: 287
EMC 10375 R. Lehman Vol #: 287
EMC 10376 R. Lehman Vol #: 287
EMC 10377 K. Foster Vol #: 287
EMC 10378 K. Foster Vol #: 374
EMC 10379 K. McVerry Vol #: 287
EMC 10380 L. Mendizabal Vol #: 287
EMC 10381 J. Hohn Vol #: 287
EMC 10382 K. Strickland Vol #: 287
EMC 10383 L. Murray Vol #: 287
EMC 10384 A. Ferguson Vol #: 287
EMC 10385 A. Thomson Vol #: 287
EMC 10386 J. Burghoffer Vol #: 287
EMC 10387 T. Thomas Vol #: 287
EMC 10388 T. Gable Vol #: 287
EMC 10389 J. Gailey Vol #: 287
EMC 10390 B. Hubbell Vol #: 287
EMC 10391 L. Profeit Vol #: 287
EMC 10392 P. Blake Vol #: 287
EMC 10393 E. Salsbiru Vol #: 287
EMC 10394 S. Hund Vol #: 287
EMC 10395 E. Christenson Vol #: 287
EMC 10396 K. Pratt Vol #: 287
EMC 10397 M. Welka Vol #: 287
EMC 10398 T. Mark Vol #: 287
EMC 10399 D. Pennington Vol #: 287
EMC 10400 K and T Burgess Vol #: 287
EMC 10401 J. Hawkins Vol #: 287
EMC 10402 A. Riley Vol #: 287
EMC 10403 K. Pollock Vol #: 287
EMC 10404 J. DeForge Vol #: 287
EMC 10405 K. Jennings Vol #: 287
EMC 10406 A. Guthery Vol #: 287
EMC 10407 S. Ginsberg Vol #: 287
EMC 10408 T. Check Vol #: 287
EMC 10409 K. Halom Vol #: 287
EMC 10410 S. Stewart Vol #: 287
EMC 10411 A. Frie Vol #: 287
EMC 10412 C. Goodwin Vol #: 287
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
EMC 1246 B. Fennell Vol #: 5
2002D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
EMC 185 P. Shepard Vol #: 3
EMC 186 P. Shepard Vol #: 3
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 364 Mission Possible International Vol #: 6
EMC 365 Mission Possible International Vol #: 6
EMC 366 Mission Possible International Vol #: 6
EMC 367 Mission Possible International Vol #: 6
EMC 368 Mission Possible International Vol #: 6
2003M-0172 PMA Cypher Sirolimus-Eluting Coronary Stent on the Raptor
SUP 1 Corid Corporation Vol #: 1
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 370 N. Landas Vol #: 9
EMC 371 J. Simmons Vol #: 9
EMC 372 A. Golan Vol #: 9
EMC 373 S. Fugua Vol #: 9
EMC 374 WM Wassell, MD Vol #: 9
EMC 375 C. Reid Vol #: 9
EMC 376 R. Hmelo Vol #: 9
EMC 377 A. Pagtalonia Vol #: 9
EMC 378 D. Gibson Vol #: 9
EMC 379 M. Goodman Vol #: 9
EMC 380 M. Goodman Vol #: 9
EMC 381 S. Hwang Vol #: 9
EMC 382 J. King Vol #: 9
EMC 383 J. Taylor Vol #: 9
EMC 384 L. Jowers Vol #: 9
EMC 385 R> Williams Vol #: 9
EMC 386 S. Goodman Vol #: 9
EMC 387 No signature Vol #: 9
EMC 388 J. Gleason Vol #: 9
EMC 389 J. Jesus Vol #: 9
2003N-0169 Dental Amalgam; Request for Information
EMC 248 Consumers for Dental Choice Vol #: 6
2003N-0312 Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
EMC 4 National Grain and Feed Assn (NGFA) Vol #: 4
2003N-0455 Training Program for Regulatory Project Managers; Information Available to Industry
EMC 1 B. Sachau Vol #: 1
2004D-0193 Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
EMC 289 M. Carpenter Vol #: 5
EMC 290 P. Kurella Vol #: 5
2004E-0425 Patent Extension for Plenaxis (abarelix), U.S. Patent No. 5,843,901
APP 1 Praecis Pharmaceuticals, Incorporated Vol #: 1
LET 1 U.S. Patent & Trademark Office Vol #: 1
2004E-0426 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,344,053
APP 1 Medtronic Vascular Vol #: 1
LET 1 U.S. Patent & Trademark Office Vol #: 1
LET 2 U.S. Patent & Trademark Office Vol #: 1
2004E-0427 Patent Extension for Ketek (telithromycin), U.S. Patent No. 5,635,485
APP 1
Continued
Aventis S.A. Vol #: 1
LET 1 U.S. Patent & Trademark Office Vol #: 1
2004H-0322 Civil Money Penalty Re: Ecumed Health Group, Inc.
MO 1 Ecumed Health Group and Amador Reyes Vol #: 1
2004N-0018 Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
EMC 5 S. Vermund, MD, PhD Vol #: 1
EMC 6 R. Candelaria Vol #: 1
EMC 7 R. Newman,MD,MPH Vol #: 1
EMC 8 J. Leiss, PhD Vol #: 1
EMC 9 Public Citizen's Health Research Group Vol #: 1
EMC 10 D. Salerno, PhD Vol #: 1
EMC 11 J. Beloqui, PhD Vol #: 1
EMC 12 D. Greco Vol #: 1
EMC 13 J. Tealdi, MD Vol #: 1
EMC 14 Latin American Forum for Ethics Committees for Health Research (FLACEIS) Vol #: 1
EMC 15 Latin American Forum for Ethics Committees for Health Research (FLACEIS) Vol #: 1
EMC 16 Prescrire International Vol #: 1
EMC 17 International Department of the Austrian Medical Chamber Vol #: 1
EMC 18 AIDS Vaccine Advocacy Coalition (AVAC) Vol #: 1
EMC 19 Dr. F Luna Vol #: 1
EMC 20 D. Egilman,MD,MPH Vol #: 1
EMC 21 European Forum for Good CLinical Practice (EFGCP) Vol #: 1
EMC 22 Bayer Pharmaceuticals Corporation Vol #: 1
EMC 23 Biotechnology Industry Organization (BIO) Vol #: 1
EMC 24 K. Fagan,MD,MPH Vol #: 1
EMC 25 R. Malone,RN,PhD Vol #: 1
EMC 26 J. Oleske,MD,MPH Vol #: 1
2004N-0081 BSE Risk Materials in Foods and Cosmetics
EMC 8 R. Chamberlain Vol #: 8
EMC 9 The Hymed Group Vol #: 8
2004N-0214 Public Information Regulations
EMC 1 B. Sachau Vol #: 1
2004N-0230 Food; Current Good Manufacturing Practice Regulations; Public Meetings
EMC 6 Assn of Food and Drug Officials (AFDO) Vol #: 2
EMC 7 Kraft Foods Global, Inc. Vol #: 2
EMC 8 National Nutritional Foods Assn (NNFA) Vol #: 2
EMC 9 Grocery Manufacturers of America (GMA) Vol #: 2
EMC 10 Food Allergy & Anaphylaxis Network (FAAN) Vol #: 2
EMC 11 Northwest Food Processors Assn (NWFPA) Vol #: 2
EMC 12 General Mills Vol #: 2
EMC 13 Shell Lubricants Global Brand Vol #: 2
EMC 14 International Dairy Foods Assn (IDFA) Vol #: 2
2004N-0264 Federal Measures to Mitigate BSE Risks: Considerations for Further Action
EMC 1413 L. Prchlik Vol #: 19
EMC 1414 No signature Vol #: 19
EMC 1415 No signature Vol #: 19
EMC 1416 K. Boatman Vol #: 19
EMC 1417 M. Preston Vol #: 19
EMC 1418 J. Shumaker Vol #: 19
EMC 1419 Penn State University Vol #: 19
EMC 1420 Caryn T. Addonizio Vol #: 19
EMC 1421 P. Schoenberg Vol #: 19
EMC 1422 Penn State University Vol #: 19
EMC 1423 M and S Lichtenfeld Vol #: 19
EMC 1424 South American Gelatin Manufacturers Assn (SAGMA) Vol #: 19
EMC 1425 G. Kuyava Vol #: 19
EMC 1426 IBM Business Consulting Services Vol #: 19
EMC 1427 Ranchers Cattleman Action Legal Fund - United Stockgrowers of America (R-CALF USA) Vol #: 19
2004N-0330 Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
EMC 1 National Mental Health Assn (NMHA) Vol #: 1
EMC 2 National Mental Health Assn (NMHA) Vol #: 1
EMC 3 M. Carbetta Vol #: 1
EMC 4 K. Eagle Vol #: 1
2004V-0424 Laser Light Show
ACK 1 HFA-305 To Poet Productions, LLC Vol #: 1
VAR 1 Poet Productions, LLC Vol #: 1

Page created on Septbemer 20, 2004 kk

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