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Dockets Management
Dockets Entered On October 15, 2004
Table of Contents
Docket # Title
1981N-0033 Oral Health Care Drug Products for OTC Human Use
1987C-0023 SAFE USE OF CARBON BLACK FOR COLORING COSMETICS
1996P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs
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
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2003P-0064 Withhold Approval of Generic Lovenox (enoxaparin sodium inje
2004N-0081 BSE Risk Materials in Foods and Cosmetics
2004N-0115 Prescription Drug Importation Study
2004N-0242 Institutional Review Boards; Registration Requirements
2004N-0264 Federal Measures to Mitigate BSE Risks: Considerations for Further Action
2004N-0267 Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications
2004N-0289 Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter
2004N-0441 Agency Information Collection Activities; Proposed Collection; Comment Request; Application For FDA Approval to Market a New Drug
2004P-0202 Notify State & Federal regulators of GRAS requirements of milk protein Concentrate
2004P-0349 Action on Products containing added Mercury
2004P-0411 Compel Enforcement and Regulation of Amyl Nitrate
1981N-0033 Oral Health Care Drug Products for OTC Human Use
C 75 Olsson, Frank and Weeda, P.C. Vol #: 72
1987C-0023 SAFE USE OF CARBON BLACK FOR COLORING COSMETICS
NFR 2 FDA Vol #: 1
1996P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs
C 831 T. Duong Vol #: 33
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
EMC 10594 B. Townsend Vol #: 294
EMC 10595 K. Quinlan Vol #: 294
EMC 10596 V. Frack Vol #: 294
EMC 10597 J. Rastegar Vol #: 294
EMC 10598 P. Pierce Vol #: 294
EMC 10599 A. Boothby Vol #: 294
EMC 10600 C. Fernquist Vol #: 294
EMC 10601 M. Lines Vol #: 294
EMC 10602 J. Mason Vol #: 294
EMC 10603 S. Whittemore Vol #: 294
EMC 10604 A. Drake Vol #: 294
EMC 10605 A. Bieritz Vol #: 294
EMC 10606 A. Leonard Vol #: 294
EMC 10607 S. Boothby Vol #: 294
EMC 10608 D. Popiel Vol #: 294
EMC 10609 A. Hansen Vol #: 294
EMC 10610 C. Fischer Vol #: 294
EMC 10611 D. Meredith Vol #: 294
EMC 10612 D. Smith Vol #: 294
EMC 10613 E. Peterman Vol #: 294
EMC 10614 S. Sirmans Vol #: 294
EMC 10615 S. Jensen Vol #: 294
EMC 10616 S. Henderson Vol #: 294
EMC 10617 D. Baker Vol #: 294
EMC 10618 K. Leonardo Vol #: 294
EMC 10619 A. Claus Vol #: 294
EMC 10620 G. Kemper Vol #: 294
EMC 10621 K. Hanratty Vol #: 294
EMC 10622 M. Galimitakis Vol #: 294
EMC 10623 S. Johnson Vol #: 294
EMC 10624 C. Patz Vol #: 294
EMC 10625 C. Krambeer Vol #: 294
EMC 10626 S. Sentz Vol #: 294
EMC 10627 A. Lintz Vol #: 294
EMC 10628 A. Walker Vol #: 294
EMC 10629 S. Whittemore Vol #: 294
EMC 10630 T. Vandergraff Vol #: 294
EMC 10631 P. Heishman Vol #: 294
EMC 10632 J. Mason Vol #: 294
EMC 10633 D. Gruber Vol #: 294
EMC 10634 K. Simpson Vol #: 294
EMC 10635 E. Johnson Vol #: 294
EMC 10636 T. Amin Vol #: 294
EMC 10637 E. Edenfield Vol #: 294
EMC 10638 D. Bailey Vol #: 294
EMC 10639 K. Mahon Vol #: 294
EMC 10640 J. Ray Vol #: 294
EMC 10641 K. Meigh Vol #: 294
EMC 10642 T. Slaughter Vol #: 294
EMC 10643 P. Patel Vol #: 294
EMC 10644 K. Lee Vol #: 294
EMC 10645 S. Scanlon Vol #: 294
EMC 10646 E. Bamberger Vol #: 294
EMC 10647 J. Kadel Vol #: 294
EMC 10648 J. Bowers Vol #: 294
EMC 10649 S. Morehead Vol #: 294
EMC 10650 P. Ren Vol #: 294
EMC 10651 M. Kuttan Vol #: 294
EMC 10652 A. Sgrignoli Vol #: 294
EMC 10653 K. Freeman Vol #: 294
EMC 10654 A. Sgrignoli Vol #: 294
EMC 10655 A. Sgrignoli Vol #: 294
EMC 10656 K. Buckwald Vol #: 294
EMC 10657 R. Malhotra Vol #: 294
EMC 10658 A. Lillian Vol #: 294
EMC 10659 B. Pickens Vol #: 294
EMC 10660 K. Sonmore Vol #: 294
EMC 10661 S. Salisbury Vol #: 294
EMC 10662 M. Erickson Vol #: 294
EMC 10663 P. Ren Vol #: 294
EMC 10664 K. Leonard Vol #: 294
EMC 10665 M. Rotolo Vol #: 294
EMC 10666 N. Aceves Vol #: 29
EMC 10667 N. Seltsam Vol #: 294
2002D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
EMC 190 G. Clark Vol #: 3
EMC 191 L. Slotnick Vol #: 3
EMC 192 A. Pitsakis Vol #: 3
EMC 193 J. Ruhl Vol #: 3
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 373 Mission Possible Intl Vol #: 6
EMC 374 R. Gordon Vol #: 6
EMC 375 Mission Possible Intl. Vol #: 6
EMC 376 Mission Possible Intl. Vol #: 6
EMC 377 Mission Possible Intl. Vol #: 6
EMC 378 Mission Possible Intl. Vol #: 6
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 419 No signature Vol #: 9
EMC 420 D. Smith Vol #: 9
EMC 421 M. Bubblo Vol #: 9
EMC 422 J. Dearing Vol #: 9
2003P-0064 Withhold Approval of Generic Lovenox (enoxaparin sodium inje
RC 1
References
Aventis Pharmaceuticals Inc. Vol #: 5
2004N-0081 BSE Risk Materials in Foods and Cosmetics
C 133 M and P Max Vol #: 13
C 134 S. Cooper Vol #: 13
C 135 A. Sigurdson Vol #: 13
C 136 S. Cormack Vol #: 13
C 137 Ajinomoto Corporate Services, LLCRobert G. Bursey Vol #: 13
C 138
Enclosure
Humane Society of the United States (HSUS) Vol #: 13
C 139 Society for Animal Protective Legislation Vol #: 13
EMC 1055 S. Ramsey Vol #: 11
EMC 1056 M. Lok Vol #: 11
EMC 1057 M. Lok Vol #: 11
EMC 1058 D. McAllister Vol #: 11
EMC 1059 S. Solarz Vol #: 11
EMC 1060 K. Banda Vol #: 11
EMC 1061 M. Havelin Vol #: 11
EMC 1062 E. Dorfman et al. Vol #: 11
EMC 1063 B. Silberg Vol #: 11
EMC 1064 D. Robinson Vol #: 11
EMC 1065 W. Lochner Vol #: 11
EMC 1066 E. Lang Vol #: 11
EMC 1067 M. Chan Vol #: 11
EMC 1068 J. Plovnick Vol #: 11
EMC 1069 J. Mejuto Vol #: 11
EMC 1070 R. English Vol #: 11
EMC 1071 J. Carter Vol #: 11
EMC 1072 M. Carter Vol #: 11
EMC 1073 L. Francis Vol #: 11
EMC 1074 E. Adair Vol #: 11
EMC 1075 B. Herner Vol #: 11
EMC 1076 C. LaRoche Vol #: 11
EMC 1077 A. Pavia Vol #: 11
EMC 1078 R. Carman Vol #: 11
EMC 1079 R. Isabella Vol #: 11
EMC 1080 P. Larson Vol #: 11
EMC 1081 A. Patoray Vol #: 11
EMC 1082 A. New Vol #: 11
EMC 1083 J. Drews Vol #: 11
EMC 1084 J. Williamson Vol #: 11
EMC 1085 C. Zigmund Vol #: 11
EMC 1086 J. Kovich Vol #: 11
EMC 1087 D. Fore Vol #: 11
EMC 1088 R. Stagman Vol #: 11
EMC 1089 S. Zigmund Vol #: 11
EMC 1090 Darling International Inc. Vol #: 11
EMC 1091 M. Herman Vol #: 11
EMC 1092 D and J Berthiaume Vol #: 11
EMC 1093 C. Byl Vol #: 11
EMC 1094 TRI-K Industries Vol #: 11
EMC 1095 M. Lok Vol #: 11
EMC 1096 B and L Hawkins Vol #: 11
EMC 1097 No signature Vol #: 11
EMC 1098 D. Rowan Vol #: 11
EMC 1099 South American Gelatin Manufacturers Assn Vol #: 11
EMC 1100 R. Dalal Vol #: 11
EMC 1101 T. Kanakaris Vol #: 11
EMC 1102 E. Elizabeth Vol #: 11
EMC 1103 A. Gledhill Vol #: 11
EMC 1104 J. LeClair Vol #: 11
EMC 1105 L. Bescript Vol #: 11
EMC 1106 D. LeClair Vol #: 11
EMC 1107 S. Mahon Vol #: 11
EMC 1108 Animal Welfare Trust (AWT) Vol #: 11
EMC 1109 People for the Ethical Treatment of Animals (PETA) Vol #: 11
EMC 1110 J. Embry Vol #: 11
EMC 1111 D. Crossmon Vol #: 11
EMC 1112 Devro, Inc. Vol #: 11
EMC 1113 Argentina Vol #: 11
EMC 1114 Nitta Casings, Inc. Vol #: 11
EMC 1115 American Assn of Meat Processors (AAMP) Vol #: 11
EMC 1116 L. Grayson, RN Vol #: 11
EMC 1117 American Assn of Meat Processors (AAMP) Vol #: 11
EMC 1118 L. Silverman Vol #: 11
EMC 1119 Humane Society of the United States (HSUS) Vol #: 11
EMC 1120 N and G Shinn Vol #: 11
EMC 1121
Attachment
Gelatin Manufacturers Assn of Japan Vol #: 11
EMC 1122
Attachment
Gelatin Manufacturers Assn of Japan Vol #: 11
EMC 1123 B. Ross Vol #: 11
2004N-0115 Prescription Drug Importation Study
EMC 23 Secure Symbology, Inc. Vol #: 19
2004N-0242 Institutional Review Boards; Registration Requirements
C 7 University of California Vol #: 1
2004N-0264 Federal Measures to Mitigate BSE Risks: Considerations for Further Action
C 190 G.A.O.B., Inc. Vol #: 23
C 191 A. Taylor Vol #: 23
EMC 1429 R. Leder, DVM Vol #: 19
2004N-0267 Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications
C 1 AstraZeneca Vol #: 1
EMC 1 Apotex, Inc. Vol #: 1
2004N-0289 Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter
C 2 A. Bell Vol #: 1
2004N-0441 Agency Information Collection Activities; Proposed Collection; Comment Request; Application For FDA Approval to Market a New Drug
N 1 FDA Vol #: 1
2004P-0202 Notify State & Federal regulators of GRAS requirements of milk protein Concentrate
EMC 8 165 signatures Vol #: 1
2004P-0349 Action on Products containing added Mercury
EMC 1 No signature Vol #: 1
EMC 2 L. Stillman Vol #: 1
EMC 3 E. Baker Vol #: 1
EMC 4 L. Stillman Vol #: 1
EMC 5 B. Johannes Vol #: 1
2004P-0411 Compel Enforcement and Regulation of Amyl Nitrate
C 1 Committee to Monitor Poppers Vol #: 1

Page created on October 18, 2004 kk
Page update March 3, 2005

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