Dockets Entered On 05/30/2003

2002N-0475 Financial Relationships & Interest in Human Research

2002N-0528 Risk Management Workshop, April 9-11, 2003 [PDUFA III]

2002P-0479 Cyproheptadine Hydrochloride Tablets;Assign a (RLD) status

2002P-0503 ANDA abbreviated new drug application for Digoxin Elixir,

2003F-0182 Ionizing radiation-control microbial contamination-dietary supplements-maxdose of 30 kiloGray

2003N-0169 Dental Amalgam; Request for Information

Docket #           Title          

2002H-0443    Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care

TR 1                HF-3                                           Vol #: 2                                                                                         

2002N-0204    Bar Code Label Requirements for human drug products                                                                        

EC 62            Loftin, Michael                              Vol #:  17                                                                                      

EC 63            McDonald, Joe                             Vol #:  17                                                                                      

2002N-0475 Financial Relationships & Interest in Human Research                                     

C 9                Pharmaceutical research and Manufacturers of America (PhRMA)  Vol #: 1                                           

C 10               Partnership for Human Research Protection, Inc. (PHRP)   Vol #: 1                                                       

C 11               Pfizer, Inc.                                   Vol #: 1                                                                                         

C 12               Johns Hopkins University              Vol #: 1                                                                                         

C 13               Applied Research Ethics National Assn (ARENA) Vol #: 1                                                                   

C 14               Virginia Commonwealth University Vol #: 1                                                                                         

C 15               Bristol-Myers Squibb Pharmaceutical Research Institute Vol #: 1                                                          

C 16               Assn of American Medical Colleges Vol #: 1                                                                                       

2002N-0528 Risk Management Workshop, April 9-11, 2003 [PDUFA III]                     

C 9                Pharmaceutical Research and Manufacturers of America (PhRMA) Vol #:3                                            

C 10               Genzyme Corporation                   Vol #: 3                                                                                         

C 11               Roche PHarmaceuticals                Vol #: 3                                                                                         

C 12               Pfizer, Inc.                                   Vol #: 3                                                                                         

2002P-0479 Cyproheptadine Hydrochloride Tablets;Assign a (RLD) status

LET 1             HFD-007 to CorePharma, LLC       Vol #: 1

2002P-0503 ANDA abbreviated new drug application for Digoxin Elixir,

WDL 1           Roxane Laboratories                     Vol #:    1

2003D-0180    Guidance: List of U.S. Dairy Product Manufacturers/Processors-Exporting to Chile                                

GDL 1            Guidance   Vol #: 1                                                                                                                           

NAD 1            FDA          Vol #: 1                                                                                                                           

2003D-0186    Guidance for Industry: Use of Material From Deer and Elk In Animal Feed                                             

GDL 1            Guidance   Vol #: 1                                                                                                                           

NAD 1            FDA          Vol #: 1                                                                                                                     

2003F-0182 Ionizing radiation-control microbial contamination-dietary supplements-maxdose of 30 kiloGray

NFL                                                                                                                                                           

C 1                 Bristol-Myers Squibb Pharmaceutical Research Institute   Vol #:  1                                                      

2003N-0169 Dental Amalgam; Request for Information                                    

C 1                American Dental Assn (ADA) Vol #: 1                                                                                                 

C 2                No signature                         Vol #: 1                                                                                                

EC 1              Richeson, Jr., James             Vol #: 4                                                                          

SUP 1            Poul Moller, MSc                  Vol #: 1                                                                          

SUP 2            Robert Siblerud                     Vol #: 1

2003N-0199    Agency Information Collection Activities: Proposed Collection; Comment Request; Importer?s Entry Notice; Extension   

N 1                 FDA                       Vol #: 1