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Dockets Management
Dockets Entered On September 27, 2004
Table of Contents
Docket # Title
1992S-0251 Electronic Submissions; Establishment of Public Docket
1996P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs
1997P-0197 Require that warning labels about risks of salmonella enteri
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
1998P-0203 Eliminate Forced Molting of Laying Birds
1999P-1340 Declared Eternity eau de Parfum Misbranded
2000N-0504 Egg Safety Action Plan
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2002D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
2002P-0317 Recall Aspartame as a Neurotoxic Drug
2003H-0432 Civil Money Penalty, Korangy Radiology Associates, PA
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2004D-0371 Class II Special Controls Guidance Document: Serological Reagents for the Detection of Beta-Glucan
2004N-0018 Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
2004N-0370 Medical Devices; Immunology and Microbiology Devices; Classification of the Beta-Glucan Serological Assay
2004N-0408 Regulatory Site Visit Training Program
2004Q-0097 Qualified Health Claim: Calcium and various cancers
2004Q-0098 Qualified Health Claim: Calcium and hypertension
2004Q-0099 Qualified Health Claim: Calcium and menstrual disorders
2004Q-0100 Qualified Health Claim: Calcium and bone fractures
2004Q-0102 Qualified Health Claim: Calcium and Kidney/urinary stones
2004Q-0144 Qualified Health Claim (QHC): Chromium picolinate and Diabetes
1992S-0251 Electronic Submissions; Establishment of Public Docket
M 31 Content Labeling, 314.50(l), 314.94(d), 601.14(b), and 314.81(b) Vol #: 1
1996P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs
NPR 2 FDA Vol #: 32
1997P-0197 Require that warning labels about risks of salmonella enteri
NPR 2 FDA Vol #: 42
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
EMC 4269 R. Markessinis Vol #: 304
1998P-0203 Eliminate Forced Molting of Laying Birds
NPR 1 FDA Vol #: 49
1999P-1340 Declared Eternity eau de Parfum Misbranded
EMC 552 Number Not Used Vol #: 304
EMC 553 M. Olsen Vol #: 24
EMC 554 K. Fine Vol #: 24
2000N-0504 Egg Safety Action Plan
EMC 294 K. Fisher Vol #: 17
EMC 295 B. Sachau Vol #: 17
EMC 296 L. Pinyan, M.S. Vol #: 17
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
EMC 10413 K. Skolnick Vol #: 294
EMC 10414 R. Schreck Vol #: 294
EMC 10415 L. DiPerna Vol #: 294
EMC 10416 M. Feld Vol #: 294
EMC 10417 M. Flood Vol #: 294
EMC 10418 M. Fulton Vol #: 294
EMC 10419 M. Abrams Vol #: 294
EMC 10420 M. Willson Vol #: 294
EMC 10421 K. Kirchner Vol #: 294
EMC 10422 C. Beals Vol #: 294
EMC 10423 J. Ingram Vol #: 294
EMC 10424 M. Vasquez Vol #: 294
EMC 10425 S. Nixon Vol #: 294
EMC 10426 B. Westby Vol #: 294
EMC 10427 M. James Vol #: 294
EMC 10428 A. King Vol #: 284
EMC 10429 C. Duncan Vol #: 294
EMC 10430 S. Zeno Vol #: 294
EMC 10431 F. Anderson Vol #: 294
EMC 10432 M. Kagan Vol #: 294
EMC 10433 M. Kagan Vol #: 294
EMC 10434 E. Edenfield Vol #: 294
EMC 10435 L. Mader Vol #: 294
EMC 10436 J. Lauzon Vol #: 294
EMC 10437 B. Bassett Vol #: 294
EMC 10438 P. Unger Vol #: 294
EMC 10439 J. Zion Vol #: 294
EMC 10440 M. Jakel Vol #: 294
EMC 10441 K. Bowden Vol #: 294
EMC 10442 D. Cosmetis Vol #: 294
EMC 10443 Z. Robinson Vol #: 294
EMC 10444 B. Cox Vol #: 294
EMC 10445 D. Cox Vol #: 294
EMC 10446 D. Cooper Vol #: 294
EMC 10447 J. McKevitt Vol #: 294
EMC 10448 H. Mathis Vol #: 294
EMC 10449 J. Farrimond Vol #: 294
EMC 10450 J. Hougland Vol #: 294
EMC 10451 A. Stevenson Vol #: 294
EMC 10452 S. Turner Vol #: 294
EMC 10453 T. Kroupa Vol #: 294
EMC 10454 J. Mudge Vol #: 294
EMC 10455 J. Price Vol #: 294
EMC 10456 A. Sidden Vol #: 294
EMC 10457 A. Colella Vol #: 294
EMC 10458 S. Wransky Vol #: 294
EMC 10459 G. Wickwire Vol #: 294
EMC 10460 J. Boss Vol #: 294
EMC 10461 E. Mabe Vol #: 294
EMC 10462 B. Axtell Vol #: 294
EMC 10463 M. Sparowr Vol #: 294
EMC 10464 T. Toly Vol #: 294
EMC 10465 M. Bates Vol #: 294
EMC 10466 P. Cherry Vol #: 294
EMC 10467 S. Vitale Vol #: 294
EMC 10468 S. Stern Vol #: 294
EMC 10469 L. Vitale Vol #: 294
EMC 10470 L. Boisvert Vol #: 294
EMC 10471 W. Mader Vol #: 294
EMC 10472 F. Smith Vol #: 294
EMC 10473 L. Mader Vol #: 294
EMC 10474 D. Cornelio Vol #: 294
EMC 10475 A. Hartry Vol #: 294
EMC 10476 H. Siegel Vol #: 294
EMC 10477 K. Perez Vol #: 294
EMC 10478 A. Biuso Vol #: 294
2002D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
EMC 187 A. Boone Vol #: 3
EMC 188 A. Urban Vol #: 3
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 369 Dr. B. Martini Vol #: 6
EMC 370 Dr. B. Martini Vol #: 6
2003H-0432 Civil Money Penalty, Korangy Radiology Associates, PA
LET 8 Korangy Radiology Association Vol #: 4
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 390 M. Collins Vol #: 9
EMC 391 T. Bellai Vol #: 9
EMC 392 M. Davin Vol #: 9
EMC 393 R. Gates Vol #: 9
EMC 394 C. Henshaw Vol #: 9
EMC 395 A. Feltz Vol #: 9
EMC 396 No signature Vol #: 9
EMC 397 J. Morgan Vol #: 9
EMC 398 S. Wilkie Vol #: 9
EMC 399 A. DeGregorio Vol #: 9
EMC 400 R. Burger, D.C., CCSP, DIBAK Vol #: 9
EMC 401 B. Levin Vol #: 9
EMC 402 P. Marcley Vol #: 9
2004D-0371 Class II Special Controls Guidance Document: Serological Reagents for the Detection of Beta-Glucan
GDL 1 Guideline Vol #: 1
NAD 1 FDA Vol #: 1
2004N-0018 Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
EMC 27 B. Haire Vol #: 1
2004N-0330 Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
EC 46 NONE Vol #: 1
EC 47 Dr. Steven Klotz Vol #: 1
2004N-0370 Medical Devices; Immunology and Microbiology Devices; Classification of the Beta-Glucan Serological Assay
NFR 1 FDA Vol #: 1
2004N-0408 Regulatory Site Visit Training Program
N 1 FDA Vol #: 1
2004Q-0097 Qualified Health Claim: Calcium and various cancers
LET 4 Emord & Associates PC Vol #: 15
2004Q-0098 Qualified Health Claim: Calcium and hypertension
LET 6 Emord & Associates PC Vol #: 9
2004Q-0099 Qualified Health Claim: Calcium and menstrual disorders
LET 4 Emord & Associates, PC Vol #: 4
2004Q-0100 Qualified Health Claim: Calcium and bone fractures
LET 4 Emord & Associates, PC Vol #: 6
2004Q-0102 Qualified Health Claim: Calcium and Kidney/urinary stones
LET 4 Emord & Associates, PC Vol #: 6
2004Q-0144 Qualified Health Claim (QHC): Chromium picolinate and Diabetes
LET 3 Emord & Associates, PC Vol #: 11

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