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DOCKETS ENTERED on 4/10/03

Docket Number - Title

LET 6 HFC-1 to European-American Phytomedicine Vol#: 2

96N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements

C 103 Peak Nutrition Inc. Vol#: 7

98D-0834 Non-Contraceptive Estrogen Class Labeling

C 16 Endeavor Pharmaceuticals Vol#: 5

EMC 2 Endeavor Pharmaceuticals Vol#: 5

98N-1109 Mercury Compounds in Drugs and Food

LET 4 GlaxoSmithKline Vol#: 2

SUP 2 Aventis Pasteur Vol#: 2

99D-1458 Enforcement Policy for FDA Personnel/Electronic Records& Sig

C 2 Genzyme Corporation Vol#: 1

99F-4372 National Fisheries Institute and the Louisiana Dep of Agricu

EMC 429 Doris Loud Vol#: 7

99F-5321 Food Safety & Inspection service safe use of ionizing radiai

EMC 332 Doris Loud Vol#: 7

99F-5322 Ionizing Radiation for the Treatment of Food

EMC 331 Doris Loud Vol#: 5

99F-5522 Ionizing radiation /control of Food-borne pathogens safe use

EMC 334 Doris Loud Vol#: 5

99P-0033 Combat the spread of transmissible spongiform encephalopathy

C 388 Mary L. Willett Vol#: 9

00D-1538 Electronic Records; Electronic Signatures, Validation

C 33 Genzyme Corporation Vol#: 8

00D-1539 Electronic Records & Signatures, Retention of Electronic Rec

C 26 Genzyme Corporation Vol#: 8

00D-1542 Electronic Signatures: Time Stamps

C 11 Genzyme Corporation Vol#: 6

00D-1543 Electronic Signatures: Glossary of Terms

C 22 Genzyme Corporation Vol#: 7

00D-1662 Use of Xenotransplantation Products in Humans

EMC 98 Terry S. Singeltary Sr. Vol#: 3

01F-0047 Foodborne pathogens in raw-frozen-cooked-partially cooked

EMC 436 Doris Loud Vol#: 7

01N-0275 Performance standard for Diagnostic X-Ray Systems & Major Co

C 1 Society for Cardiac Angiography & Interv Vol#: 1

C 2 University of California, Berkeley Vol#: 1

C 3 Society of Interventional Radiology Vol#: 1

C 4 State of Illinois Dept. of Nuclear Safet Vol#: 1

EMC 1 Stephen Balter, Ph.D., FACR, FAAPM Vol#: 1

02D-0018 Race and Ethnicity Data in Clinical Trials for FDA

C 22 Christine Blank et al. Vol#: 1

EMC 2 Lab Communications, Inc. Vol#: 1

02D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate

EMC 107 Stephanie Alley Vol#: 3

02N-0276 Bioterrorism Preparedness;Registration of Food Facilities

C 118 Dole Fresh Vegetables, Inc. Vol#: 9

C 119 Coalition for Safe Ceramicware, Inc. Vol#: 9

C 120 Embassy of Spain Vol#: 9

C 121 Grocery Manufacturers of America (GMA) Vol#: 9

C 122 National Beer Wholesalers Assn (NBWA) Vol#: 9

C 123 Food Marketing Institute (FMI) Vol#: 9

C 124 International Dairy Foods Assn (IDFA) Vol#: 9

C 125 BC Hot House Foods, Inc. (BCHH) Vol#: 9

C 126 The European Communities Vol#: 9

C 127 National Institute of Oilseed Products Vol#: 9

C 128 NCBFAA Vol#: 9

C 129 SAGARPA Vol#: 9

C 130 Grunfeld, Desiderio, Lebowitz, Silverman Vol#: 9

C 131 National Tank Truck Carriers Vol#: 10

C 132 Paperboard Packaging Council (PPC) Vol#: 10

C 133 American Wholesale Marketers Assn Vol#: 10

C 134 Healthcare Distribution Management Assn Vol#: 10

C 135 The Fisheries Assn of Newfoundland and L Vol#: 10

C 136 Society of the Plastics Industry, Inc. Vol#: 10

C 137 Salmon Industry Assn Vol#: 10

C 138 L.D. Tonsager & Sons, Inc. Vol#: 10

C 139 UOP LLC Vol#: 10

C 140 Council for Responsible Nutrition (CRN) Vol#: 10

C 141 American Frozen Food Institute (AFFI) Vol#: 10

C 142 National Food Processors Assn (NFPA) Vol#: 10

C 143 E & J Gallo Winery Vol#: 10

02N-0475 Draft "Financial Relationships & Interest in Research Involv

EMC 1 AHRP, The Alliance for Human Res. Protec Vol#: 1

02P-0168 Request better product labeling of sports & energy beverages

EMC 1 Citizen Outreach Vol#: 1

02P-0435 Effective Approval of Alphanate Antihemophilic Factor

C 13 Georgetown University Hospital Vol#: 1

C 14 Cook Children's Hematology & Oncology Ct Vol#: 1

02P-0447 Immediately revoke its acceptance for NDA 21-435 for amlodin

C 1 Dr. Reddy's Laboratories, Inc. Vol#: 1

03D-0001 Nonclinical Safety Evaluation of Pediatric Drug Products

C 1 Pharmacia Corp. Vol#: 1

03D-0060 Part11, Electronic records, electronic signatures scope

C 2 Genzyme Corporation Vol#: 1

03D-0118 Decorative Contact Lens (Import alert #86-10)

EMC 1 Terry S. Singeltary Vol#: 1

03E-0145 Patent Term Extension Application for XIGRIS, No. 5,270,040

APP 1 Eli Lilly and Company Vol#: 1

LET 1 U.S. Patent & Trademark Office Vol#: 1

03E-0146 Patent Extension Application for RELPAX, No. 5,545,644

APP 1 Pfizer Inc. Vol#: 1

LET 1 U.S. Patent & Trademark Office Vol#: 1

03E-0147 Patent Extension Application for FROVA, No. 5,464,864

APP 1 Vernalis Limited Vol#: 1

LET 1 U.S. Patent & Trademark Office Vol#: 1

03E-0149 Patent LEXAPRO (escitalopram oxalate) Patent No. 34,712

APP 1 Darby & Darby, P.C Vol#: 1

LET 1 Darby & Darby, P.C Vol#: 1

03E-0150 Patent extension ABILIFY (aripiprazole) Patent No. 5,006,528

APP 1 Finnegan,Henderson,Farabow,Garrett & Du Vol#: 1

LET 1 Finnegan,Henderson,Farabow,Garrett & Du Vol#: 1

03E-0151 PatentGEODON orZeldox(ziprasidone HCI monohydrate)4,831,031

APP 1 Pfizer Inc. Vol#: 1

LET 1 Pfizer Inc. Vol#: 1

03E-0152 Patent extentsin RANEXA (ranolazine) 4,567,264

APP 1 Heller Ehrman White & Mcauliffe LLP Vol#: 1

LET 1 Heller Ehrman White & Mcauliffe LLP Vol#: 1

03E-0153 Patent Extension #5,420,319 for Eloxatin (oxaliplatin)

APP 1 Sanofi-Synthelabo, Inc. Vol#: 1

03E-0154 Patent Term Extension of U.S. Patent #4,328,809

APP 1 Barry Hirschowitz Vol#: 1