Dockets Entered On August 19, 2003

Table of Contents

Docket #

Title

1996N-0417. 1   CGMP in Mfg. Packing or Holding Dietary Supplements. 1

1997S-0162. 1   30-Day Structure Function Claim Notification Letters Dietary. 1

2000N-1571. 1   Enrofloxacin for Poultry: Opportunity for Hearing. 1

2002P-0505. 1   Labeling nuts & eligible nut containing products reduce risk. 1

2003D-0231. 1   Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format -- Postmarketing Periodic Adverse Drug Experience Reports; Availability  1

2003D-0349. 1   Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs) 1

2003N-0232. 1   Universal Reagents, Inc.; Opportunity for Hearing on a Proposal to Revoke U.S. License No. 0887  1

2003V-0374. 1   Laser Light Show. 1

1996N-0417

CGMP in Mfg. Packing or Holding Dietary Supplements

EMC 248

Kemin Foods LC

Vol #:

39

EMC 249

Helen De Faye

Vol #:

39

EMC 250

Wyeth Consumer Healthcare

Vol #:

39

EMC 251

Randy and Linda

Vol #:

39

EMC 252

Rob Buckle

Vol #:

39

1997S-0162

30-Day Structure Function Claim Notification Letters Dietary

LET 10529

Enzymatic Therapy Nautral Medicines

Vol #:

80

LET 10530

Weider Nutrition International Inc.

Vol #:

80

LET 10531

Weider Nutrition International, Inc.

Vol #:

80

LET 10532

Weider Nutrition International, Inc.

Vol #:

80

2000N-1571

Enrofloxacin for Poultry: Opportunity for Hearing

RBF 1

Center for Veterinary Medicine

Vol #:

389

RBF 2

Center for Veterinary Medicine

Vol #:

389

RBF 3

Bayer Corporation

Vol #:

389

RBF 4

Animal Health Institute

Vol #:

389

2002P-0505

Labeling nuts & eligible nut containing products reduce risk

C 9

Congress of the United States

Vol #:

4

C 10

United States Senate

Vol #:

4

2003D-0231

Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format -- Postmarketing Periodic Adverse Drug Experience Reports; Availability

C 1

Genzyme Corporation

Vol #:

1

C 2

Bristol-Myers Squibb Pharmaceutical Research Institute

Vol #:

1

2003D-0349

Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs)

GDL 1

Guidance

Vol #:

1

2003N-0232

Universal Reagents, Inc.; Opportunity for Hearing on a Proposal to Revoke U.S. License No. 0887

HER 1

Universal Reagents Inc. (URI)

Vol #:

1

M 1

HFM-17 and Priscilla A Hoppe, Consultant

Vol #:

1

2003V-0374

Laser Light Show

ACK 1

HFA-305 to Beaming Man

Vol #:

1

VAR 1

Beaming Man

Vol #:

1