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Dockets Management
Dockets Entered On April 23, 2004
Table of Contents
Docket # Title
1981N-0050 OTC for treatment of acute toxic ingestion human use
1992N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992
1996V-0210 Variance for Laser Light Show
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1998D-1146 Microbial effects of antimicrobial new animal drugs/human sa
1999V-0190 Variance Laser Light Show LSD110XL MRAK10 & MRAK250
2000P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods
2000P-1322 Food Labeling and Allergen Contamination Control
2000P-1439 Iceberg Water Deviating From Identity Standard
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2002P-0520 Reclassification of Beta-Tricalcium Phosphate,
2003D-0570 Draft on the Clinical Evaluation of Weight-Control Drugs
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2003N-0324 New Animal Drugs; Removal of Obsolete and Redundant Regulations
2003N-0327 Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on How to Use E-Mail to Submit a Request For a Meeting or Teleconference to the Office of New Anim
2003N-0525 Agency Information Collection Activities: Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point (HAACP); Procedures for the Safe and Sanitary Processing and Importing of Jui
2003P-0029 Remove metered-dose inhalers (MDI) containing moiety albuter
2003P-0479 Allow importation of Canadian versions of drugs that are approved to the United States
2004D-0156 International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Guidance for Industry on b
2004N-0086 Diabetes: Targeting Safe and Effective Prevention and Treatment; Public Meeting
2004N-0166 Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Feeding Practices Study II
2004N-0181 Critical Path Initiative
2004V-0119 Laser Light Show
2004V-0138 Laser Light Show
2004V-0190 LaserLlight Show
2004V-0191 Laser Light Show
1981N-0050 OTC for treatment of acute toxic ingestion human use
SUP 1
Appendix 1, 2, 3
American Assn of Poison Control Centers (AAPCC) Vol #: 1
1992N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992
C 130
Tab 1
Pharmaceutical Distributors Assn (PDA) Vol #: 10
1996V-0210 Variance for Laser Light Show
VRA 5 HFZ-300 to LaserSmith Light Show Systems Vol #: 1
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 13776 The Fitzpatrick Group, Inc. Vol #: 116
LET 13777 BioAdvantex Pharm Inc. Vol #: 116
LET 13778 BioAdvantex Pharm Inc. Vol #: 116
LET 13779 Herb Pharm Vol #: 116
LET 13780 Michael's Naturopathic Programs Vol #: 116
LET 13781 Nature's Sunshine Products, Inc. Vol #: 116
LET 13782 AdvoCare Vol #: 116
LET 13783 Integrative Therapeutics Inc. Vol #: 116
LET 13784 Integrative Therapeutics Inc. Vol #: 116
LET 13785 Integrative Therapeutics Inc. Vol #: 116
LET 13786 Perrigo Company of South Carolina Vol #: 116
LET 13787 Perrigo Company of South Carolina Vol #: 116
LET 13788 Perrigo Company of South Carlina Vol #: 116
LET 13789 Perrigo Company of South Carolina Vol #: 116
LET 13790 Market America, Inc. Vol #: 116
1998D-1146 Microbial effects of antimicrobial new animal drugs/human sa
C 106
Continued
Animal Health Institute (AHI) Vol #: 62
1999V-0190 Variance Laser Light Show LSD110XL MRAK10 & MRAK250
VRA 3 HFZ-300 to Artistic Laser Productions Vol #: 1
2000P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods
EMC 5819 Gillie Ocepack Vol #: 789
EMC 5820 Elizabeth Kempf Vol #: 789
EMC 5821 Elizabeth Kempf Vol #: 789
EMC 5822 Jeff Cordulack Vol #: 789
EMC 5823 Chris Thiel Vol #: 789
2000P-1322 Food Labeling and Allergen Contamination Control
C 545 C. Jahrling Vol #: 30
2000P-1439 Iceberg Water Deviating From Identity Standard
LET 2 HFS-822 to Iceberg Industries Corporation Vol #: 1
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
C 1342 Form Letter Vol #: 212
C 1343 Form Letter Vol #: 215
C 1344 Form Letter Vol #: 228
C 1345 Form Letter Vol #: 230
C 1346 Form Letter Vol #: 233
EMC 5997 S. Bratt Vol #: 211
EMC 5998 V. Connolly Vol #: 211
EMC 5999 M. G. Neumann Vol #: 211
EMC 6000 M. Gewirtzman Vol #: 211
EMC 6001 N. Elkin Vol #: 211
EMC 6002 J. Bourke Vol #: 211
EMC 6003 B. Flaus Vol #: 211
EMC 6004 D. A. Phillips PH.D. Vol #: 211
EMC 6005 V. E. Alexander Vol #: 211
EMC 6006 L. Alicie Vol #: 211
EMC 6007 L. Frame Vol #: 211
EMC 6008 K. Robinson Vol #: 211
EMC 6009 L. Rogers Vol #: 211
EMC 6010 Rev. G. Hope Vol #: 211
EMC 6011 E. Cloke Vol #: 211
EMC 6012 K. Conroy Vol #: 211
EMC 6013 E. Jurgensen Vol #: 211
EMC 6014 N. Blue Vol #: 211
EMC 6015 D. Brinn Vol #: 211
EMC 6016 O. D. Cornyn Vol #: 211
EMC 6017 E. Thunen Vol #: 211
EMC 6018 K. Amerell Vol #: 211
EMC 6019 N. Cole Vol #: 211
EMC 6020 S. Johnston Vol #: 211
EMC 6021 M. Dwor Vol #: 211
EMC 6022 K. Turner Vol #: 211
EMC 6023 R. A. Mackie Vol #: 211
EMC 6024 M. DEaley Vol #: 211
EMC 6025 S. Davis Vol #: 211
EMC 6026 H. Wise Vol #: 211
EMC 6027 T. French Vol #: 211
EMC 6028 C. Gilbert Vol #: 211
EMC 6029 R. Murray Vol #: 211
EMC 6030 C. E. Phillips Vol #: 211
EMC 6031 L. Winters Vol #: 211
EMC 6032 E. J. Reinhart Vol #: 211
EMC 6033 H. Woodworth Vol #: 211
EMC 6034 B. J. Carroll Vol #: 211
EMC 6035 A. Revallo Vol #: 211
EMC 6036 A. M. Dunne Vol #: 211
EMC 6037 J. Wells Vol #: 211
EMC 6038 K. Gordon Vol #: 211
EMC 6039 J. Hodgson, II Vol #: 211
EMC 6040 B. Silkes Vol #: 211
EMC 6041 J. Crocker Vol #: 211
EMC 6042 C. Vogeley Vol #: 211
EMC 6043 A. Ravin Vol #: 211
EMC 6044 J. Marvin Vol #: 211
EMC 6045 S.Felix Vol #: 211
EMC 6046 F. Narod Vol #: 211
EMC 6047 L. Shattuck Vol #: 211
EMC 6048 S. Mullally Vol #: 211
EMC 6049 V. Kelch Vol #: 211
EMC 6050 M. Paulson Vol #: 211
EMC 6051 A. A. Clark Vol #: 211
EMC 6052 S. Brinn Vol #: 211
EMC 6053 A. Sayers Vol #: 211
EMC 6054 R. D. Castillo Vol #: 211
EMC 6055 J. Embry Vol #: 211
EMC 6056 J. Mock Vol #: 211
EMC 6057 C. Simo Vol #: 211
EMC 6058 J. Delfs Vol #: 211
EMC 6059 B. Samuels Vol #: 211
EMC 6060 N. McLellan Vol #: 211
EMC 6061 W. Peterson-nedry Vol #: 211
EMC 6062 D. A. Sylvia, Med Vol #: 211
EMC 6063 Rev. D. Myers J.D. Vol #: 211
EMC 6064 M. Habaibeh Vol #: 211
EMC 6065 M. F. Trester Vol #: 211
EMC 6066 M. Carr Vol #: 211
EMC 6067 L. Walker Vol #: 211
EMC 6068 T. Walters Vol #: 211
EMC 6069 D. Tierney Vol #: 211
EMC 6070 A. Fitzpatrick Vol #: 211
EMC 6071 S. Strong Vol #: 211
EMC 6072 V. Wood Vol #: 211
EMC 6073 Rev. Dr. S. G. Hall, III Vol #: 211
EMC 6074 A. R. Nolan Vol #: 211
EMC 6075 L. Fiddes Vol #: 211
EMC 6076 L . Anatale Vol #: 211
EMC 6077 G. J. Ablove Vol #: 211
EMC 6078 D. DeSocio Vol #: 211
EMC 6079 C. Fiddes Vol #: 211
EMC 6080 A. R. Richter Vol #: 211
EMC 6081 K. Richardson Vol #: 211
EMC 6082 K. Portwood Vol #: 211
EMC 6083 C. Carrubba Vol #: 211
EMC 6084 A. Sharp Vol #: 211
EMC 6085 D. Myer Vol #: 211
EMC 6086 R. M. Hervey Vol #: 211
EMC 6087 J. Valle Vol #: 211
EMC 6088 R. Rashti, MD Vol #: 211
EMC 6089 C. Kelly Vol #: 211
EMC 6090 M. Henry Vol #: 211
EMC 6091 T. K. Wang Vol #: 211
EMC 6092 V. Moen Vol #: 211
EMC 6093 C. Tausend Vol #: 211
EMC 6094 A.T. Ageson Vol #: 211
EMC 6095 S. Baugh Vol #: 211
EMC 6096 J. Helle Vol #: 211
EMC 6097 R. G.Cardella Vol #: 211
EMC 6098 J. Blankenship Vol #: 211
EMC 6099 No Signature Vol #: 211
EMC 6100 D. Wolf Vol #: 211
2002P-0520 Reclassification of Beta-Tricalcium Phosphate,
BKG 1 HFZ-215 Vol #: 3
LET 2 Bicon, Inc. Vol #: 1
2003D-0570 Draft on the Clinical Evaluation of Weight-Control Drugs
C 3 Eli Lilly and Company (Lilly) Vol #: 1
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
C 22 Daniels Midland Company (ADM) Vol #: 7
C 23 Stephan Company Vol #: 7
2003N-0324 New Animal Drugs; Removal of Obsolete and Redundant Regulations
BKG 2 Background Material Refs 1 - 14 Vol #: 3
NPR 2 FDA Vol #: 3
2003N-0327 Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on How to Use E-Mail to Submit a Request For a Meeting or Teleconference to the Office of New Anim
NAL 1 FDA Vol #: 1
SS 1 Supporting Statement Vol #: 1
2003N-0525 Agency Information Collection Activities: Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point (HAACP); Procedures for the Safe and Sanitary Processing and Importing of Jui
N 2 FDA Vol #: 1
2003P-0029 Remove metered-dose inhalers (MDI) containing moiety albuter
C 9 Honeywell Chemicals Vol #: 2
2003P-0479 Allow importation of Canadian versions of drugs that are approved to the United States
LET 1 HFD-005 to The City of Springfield, Massachusetts Vol #: 1
2004D-0156 International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Guidance for Industry on b
GDL 1 Guideline Vol #: 1
NAD 1 FDA Vol #: 1
2004N-0086 Diabetes: Targeting Safe and Effective Prevention and Treatment; Public Meeting
C 2 G. Lewis RN,BC,EdM,CDE Vol #: 1
2004N-0166 Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Feeding Practices Study II
N 1 FDA Vol #: 1
2004N-0181 Critical Path Initiative
N 1 FDA Vol #: 1
2004V-0119 Laser Light Show
VRA 1 HFZ-300 to John Coodey CLLS Vol #: 1
2004V-0138 Laser Light Show
VRA 1 HFZ-300 to The Beat of Time Vol #: 1
2004V-0190 LaserLlight Show
ACK 1 HFA-305 to Stealth DJ's Mobile Disc Jockey Service Vol #: 1
VAR 1 Stealth DJ's Mobile Disc Jockey Service Vol #: 1
2004V-0191 Laser Light Show
ACK 1 HFA-305 to New Jersaey State Museum Planettarium Vol #: 1
VAR 1 New Jersaey State Museum Planettarium Vol #: 1

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