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Dockets Management
Dockets Entered On June 28, 2004
Table of Contents
Docket #    Title 
 
1976N-0052G OTC general comments & combinations
1985V-0287 Laser light show & projector
1994P-0390 Adopt Amendments Governing Health Claims & Nutrient Claims
1995P-0241 Implied Nutrient Content Claim "Healthy" & Health Claims
1997P-0056 Caloric value not more than two per gram for soluble fiber
1997V-0455 Laser Light Show
1999E-5116 Patent Extension: Xoponex, levalbuterol hcl, #5,362,755
1999N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2001P-0230 Domestic Marketing & Importation of Transgenic Fish
2001V-0084 Laser light show
2002E-0149 Genesis Neurostimulation System, U.S. Patent No. 4,793,353
2002N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
2003D-0060 Part11, Electronic records, electronic signatures scope
2003D-0206 Draft Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products; Availability
2003D-0290 Compounding of Drugs for Use in Animals Compliance Policy Guide
2003D-0571 Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
2003E-0150 Patent extension ABILIFY (aripiprazole) Patent No. 5,006,528
2003E-0153 Patent Extension #5,420,319 for Eloxatin (oxaliplatin)
2003E-0246 Patent Extension for Deramaxx (deracoxib), 5,521,207,
2003E-0247 Patent Extension for Campath (Alemtuzumab), 5,545,403
2003E-0249 Patent Extension for Elitek (rasburicase) 5,382,518
2003E-0250 Patent Extension for Invanz (ertapenem sodium), 5,478,820
2003E-0251 Patent 5,667,787, Daptacel (Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine)
2003E-0253 Patent Extension for Lexapro (escitalopram oxalate), 34,712
2003E-0257 Patent Extension for Neotame, 5,480,668
2003E-0261 Patent Extension for Strattera (atomoxetine hydrochloride), 5,658,590
2003E-0405 Patent Term Restoraton Application for Neutersol (zinc gluconate), U.S. Patent No. 5,070,080
2003E-0452 Patent Extension, Neutersol, zinc gluconate, Patent No. 4,937,234
2003N-0205 Exocrine Pancreatic Insufficiency Drug Products
2003N-0539 Over-the-Counter Drug Products; Safety and Efficacy Review
2003P-0387 Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
2003P-0544 Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
2004N-0133 Part 11, Electronic Record; Electronic Signatures; Public Meeting
2004N-0221 Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Section 107(f) b
2004N-0230 Food; Current Good Manufacturing Practice Regulations; Public Meetings
2004N-0254 Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children
2004P-0003 Petition to reconsider the Food and Drug Administration's decision on the Med Watch complaint
2004P-0059 Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis
2004P-0060 Health Claim Petition: Glucosamine Sulfate and Osteoarthritis
2004P-0061 Take actions to establish guidance and clarify requirements for abbreviated new drug applications with regard to levothyroxine sodium products
2004P-0197 ANADA for Pig Pump Oral Solution, NADA 130-464
2004P-0202 Notify State & Federal regulators of GRAS requirements of milk protein Concentrate
2004P-0231 Deny approval of NDA 21-426 for Ominitrop 5.8 mg somatropin [ rDNA origin ] for injection, lyophilized powder and diluent with preservative
2004S-0270 Notice Announcing Publication of the Report to Congress Entitled Plan for the Transfer of Responsibility for Medicare Appeals and Soliciting Comments
2004V-0272 Projector for a Laser Light Show
2004V-0273 Laser Light Show
1976N-0052G OTC general comments & combinations
LET 123 Lil Drug Store Products, Inc. Vol #: 35
1985V-0287 Laser light show & projector
VRA 10 HFZ-300 to Centrak Laser Design Group Vol #: 1
1994P-0390 Adopt Amendments Governing Health Claims & Nutrient Claims
C 61 POM Wonderful, LLC Vol #: 5
1995P-0241 Implied Nutrient Content Claim "Healthy" & Health Claims
C 78 POM Wonderful, LLC Vol #: 5
1997P-0056 Caloric value not more than two per gram for soluble fiber
C 1 International Food Additives Council Vol #: 2
1997V-0455 Laser Light Show
VRA 4 HFZ-300 to CourtYards of Mackinaw Vol #: 1
1999E-5116 Patent Extension: Xoponex, levalbuterol hcl, #5,362,755
LET 3 HFD-005 to US Patent & Trademark Office Vol #: 1
1999N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings
C 18226 M. Lande Vol #: 516
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
EMC 791 Charles Tazzia Vol #: 271
EMC 792 Jane Fronek Vol #: 271
EMC 793 Thomas Aldridge Vol #: 271
EXB 161 Center for Veterinary Medicine Vol #: 415
EXB 162 Center for Veterinary Medicine Vol #: 415
EXB 163 Center for Veterinary Medicine Vol #: 415
EXB 164 Center for Veterinary Medicine Vol #: 415
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
EMC 7403 B. Benton Vol #: 270
EMC 7404 V. Tarico Vol #: 279
EMC 7405 A. Ismach Vol #: 279
EMC 7406 D. Hart Vol #: 279
EMC 7407 N. Mcgowan Vol #: 279
EMC 7408 F. Hansen Vol #: 279
EMC 7409 P. Schneider Vol #: 279
EMC 7410 K. Rider Vol #: 279
EMC 7411 P. Goodwin M.D. Vol #: 279
EMC 7412 A. Brumback Vol #: 279
EMC 7413 S. Miller Pharm.D. Vol #: 279
EMC 7414 E. Bell Vol #: 279
EMC 7415 K. Tirimacco Vol #: 279
EMC 7416 K.. Kasameyer Vol #: 279
EMC 7417 C. Henry Vol #: 279
EMC 7418 R. & J. Lyle Vol #: 279
EMC 7419 J. Johnson Vol #: 279
EMC 7420 K. Daniels Vol #: 279
EMC 7421 S. McKibben Vol #: 279
EMC 7422 P. Jayne Vol #: 279
EMC 7423 C. J. Schroeder Vol #: 279
EMC 7424 C. Wurster Vol #: 279
EMC 7425 M. Patterson Vol #: 279
EMC 7426 M. Stacy Vol #: 279
EMC 7427 M. Cox Vol #: 279
EMC 7428 L. Raymond Vol #: 279
EMC 7429 P. Reynolds Vol #: 279
EMC 7430 D. Strasfogel Vol #: 279
EMC 7431 C. Lloyd Vol #: 279
EMC 7432 Siri Okamoto Vol #: 279
EMC 7433 S. Jackson Vol #: 279
EMC 7434 D. Therol-chaffin Vol #: 279
EMC 7435 L. Hershey Vol #: 279
EMC 7436 A. Musgierd Vol #: 279
EMC 7437 K. C. Tinghitella Vol #: 279
EMC 7438 W. Phinney Vol #: 279
EMC 7439 H. G. Kripal Vol #: 279
EMC 7440 P. Pitts Vol #: 279
EMC 7441 C. Hickey Vol #: 279
EMC 7442 C. Burleson Vol #: 179
EMC 7443 K. Drees Vol #: 279
EMC 7444 S. T.Kruger Vol #: 279
EMC 7445 K. Bohrer Vol #: 279
EMC 7446 L. Wickstrom Vol #: 279
EMC 7447 C. Saunders Vol #: 279
EMC 7448 D. Baum Vol #: 279
EMC 7449 L. Pfatteicher Vol #: 279
EMC 7450 E. Cook Vol #: 279
EMC 7451 L. Buntley Vol #: 279
EMC 7452 G. Heinrichs Vol #: 279
EMC 7453 H. Goodale Vol #: 279
EMC 7454 R. S. Morrison Vol #: 279
EMC 7455 L. Evans Vol #: 279
EMC 7456 R. K. Powers Vol #: 279
EMC 7457 S. Nett Vol #: 279
EMC 7458 J. R. beach Vol #: 279
EMC 7459 N. Cerkvenik Vol #: 279
EMC 7460 N. Cerkvenik Vol #: 279
EMC 7461 B. Johnson Vol #: 279
EMC 7462 M. Schrey Vol #: 279
2001P-0230 Domestic Marketing & Importation of Transgenic Fish
C 1358 M. Lande Vol #: 259
SUP 2
Attachment
The Center for Food Safety (CFS) Vol #: 259
2001V-0084 Laser light show
VRA 2 HFZ-300 to Frankenmuth river Place, LLC Vol #: 1
2002E-0149 Genesis Neurostimulation System, U.S. Patent No. 4,793,353
LET 5 HFD-005 to US Patent & Trademark Office Vol #: 1
2002N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
C 349 National Customs Brokers and Forwarders Assn of America, Inc. (NCBFAA) Vol #: 29
2003D-0060 Part11, Electronic records, electronic signatures scope
C 34 Bulk Pharmaceuticals Task Force (BPTF) Vol #: 3
2003D-0206 Draft Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products; Availability
C 1 Digestive Care, Inc. Vol #: 1
C 2 Solvay Pharmaceuticals Vol #: 1
2003D-0290 Compounding of Drugs for Use in Animals Compliance Policy Guide
C 9
Part 2, Part 3,
Consumer Letters
International Academy of Compounding Pharmacists (IACP) Vol #: 2
2003D-0571 Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
C 6 Synthetic Chemical Manufacturer's Assn (SOCMA) Vol #: 1
2003E-0150 Patent extension ABILIFY (aripiprazole) Patent No. 5,006,528
LET 4 HFD-005 to US Patent & Trademark Office Vol #: 1
2003E-0153 Patent Extension #5,420,319 for Eloxatin (oxaliplatin)
LET 4 HFD-005 to US Patent & Trademark Office Vol #: 1
2003E-0246 Patent Extension for Deramaxx (deracoxib), 5,521,207,
LET 4 HFD-005 to US Patent & Trademark Office Vol #: 1
2003E-0247 Patent Extension for Campath (Alemtuzumab), 5,545,403
LET 3 HFD-005 to US Patent & Trademark Office Vol #: 1
2003E-0249 Patent Extension for Elitek (rasburicase) 5,382,518
LET 4 HFD-005 to US Patent & Trademark Office Vol #: 1
2003E-0250 Patent Extension for Invanz (ertapenem sodium), 5,478,820
LET 4 HFD-005 to US Patent & Trademark Office Vol #: 1
2003E-0251 Patent 5,667,787, Daptacel (Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine)
LET 3 HFD-005 to US Patent & Trademark Office Vol #: 1
2003E-0253 Patent Extension for Lexapro (escitalopram oxalate), 34,712
LET 4 HFD-005 to US Patent & Trademark Office Vol #: 1
2003E-0257 Patent Extension for Neotame, 5,480,668
LET 5 HFD-005 to US Patent & Trademark Office Vol #: 1
2003E-0261 Patent Extension for Strattera (atomoxetine hydrochloride), 5,658,590
LET 5 HFD-005 to US Patent & Trademark Office Vol #: 1
2003E-0405 Patent Term Restoraton Application for Neutersol (zinc gluconate), U.S. Patent No. 5,070,080
LET 4 HFD-005 to US Patent & Trademark Office Vol #: 1
2003E-0452 Patent Extension, Neutersol, zinc gluconate, Patent No. 4,937,234
LET 5 HFD-005 to US Patent & Trademark Office Vol #: 1
2003N-0205 Exocrine Pancreatic Insufficiency Drug Products
C 1 Scientific Protein Laboratories, LLC Vol #: 1
C 2 Digestive Care, Inc. Vol #: 1
2003N-0539 Over-the-Counter Drug Products; Safety and Efficacy Review
C 2 C.B. Fleet Company, Inc. (C.B. Fleet) Vol #: 1
C 3 Personal Products Company Vol #: 1
C 4
Table of Contents,
Tab 1, 2, 3-8
INGfertility Vol #: 3
C 5
Attachment, Appendices, Tabulations
Johnson & Johnson Vol #: 4
C 6
Exhibits
B.F. Ascher & Company, Inc. Vol #: 5
2003P-0387 Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
MM 1 FDA & Abbott Laboratories met January 13, 2004 Vol #: 5
2003P-0544 Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
C 36 M. Lande Vol #: 2
2004N-0133 Part 11, Electronic Record; Electronic Signatures; Public Meeting
C 10 The Dow Chemical Company (DOW) Vol #: 4
2004N-0221 Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Section 107(f) b
C 10 ASKO Corporation Vol #: 1
C 11 J. Sanders Vol #: 1
C 12 W. Cater Vol #: 1
C 13 En Vision America, Inc. Vol #: 1
2004N-0230 Food; Current Good Manufacturing Practice Regulations; Public Meetings
APE 1 Morton Salt Vol #: 1
2004N-0254 Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children
N 1 FDA Vol #: 1
2004P-0003 Petition to reconsider the Food and Drug Administration's decision on the Med Watch complaint
LET 5 Billy G. Pierson Vol #: 1
LET 6 Billy G. Pierson Vol #: 1
LET 7 Billy G. Pierson Vol #: 1
2004P-0059 Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis
SUP 7
Attachment
Weider Nutrition International, Inc. Vol #: 13
2004P-0060 Health Claim Petition: Glucosamine Sulfate and Osteoarthritis
SUP 2
Attachment
Weider Nutrition International, Inc. Vol #: 3
2004P-0061 Take actions to establish guidance and clarify requirements for abbreviated new drug applications with regard to levothyroxine sodium products
MM 1 FDA & Jerome Stevens Pharmaceuticals Inc met April 14, 2004 Vol #: 1
PDN 1 HF-22 to Alston & Bird, LLP Vol #: 1
2004P-0197 ANADA for Pig Pump Oral Solution, NADA 130-464
PAV 1 HFV-100 to First Priority, Inc. Vol #: 1
2004P-0202 Notify State & Federal regulators of GRAS requirements of milk protein Concentrate
C 7 L. Smith Vol #: 1
2004P-0231 Deny approval of NDA 21-426 for Ominitrop 5.8 mg somatropin [ rDNA origin ] for injection, lyophilized powder and diluent with preservative
C 1 Engel & Novitt, LLP Vol #: 2
2004S-0270 Notice Announcing Publication of the Report to Congress Entitled Plan for the Transfer of Responsibility for Medicare Appeals and Soliciting Comments
N 1 FDA Vol #: 1
2004V-0272 Projector for a Laser Light Show
ACK 1 HFA-305 toFan Yang Vol #: 1
VAR 1 Fan Yang Vol #: 1
2004V-0273 Laser Light Show
ACK 1 HFA-305 to Vybe Entertainment Vol #: 1
VAR 1 VybeEntertainment Vol #: 1

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