DOCKETS MANAGEMENT

Dockets Entered On July 17, 2003

Table of Contents

Docket #

Title

1978N-0301

OTC External Analgesic Drug Products

1996N-0417

CGMP in Mfg. Packing or Holding Dietary Supplements

1997P-0441

Regulatory Status of Cholestin red yeast rice

1998P-0610

Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC

2001P-0345

Listing the color additive yellow #5 for use in food/Drug

2002D-0526

Guidance for drug Chemistry, Manufacturing, Control Info.

2002P-0292

Health Claims: Walnuts & Cornary Disease

2002P-0505

Labeling nuts & eligible nut containing products reduce risk

2003D-0165

Current Good Manufacturing Practices for Medical Gases

2003D-0186

Guidance for Industry: Use of Material From Deer and Elk In Animal Feed

2003D-0195

Draft Guidance for Industry on Necessity of the Use of Food Product Categories in Registration of Food Facilities

2003N-0168

July 31, 2003 Public Meeting on Consumer Medication Information

2003N-0169

Dental Amalgam; Request for Information

2003P-0132

Part 135 FDA regulations standard of identity frozen dessert

Details

1978N-0301

OTC External Analgesic Drug Products

NPR 7

FDA

Vol #:

102

1994V-0346

Laser Light show

VRA 4

HFZ-300 to Mueller Planetarium

Vol #:

1

1996N-0417

CGMP in Mfg. Packing or Holding Dietary Supplements

C 128

Nature's Cupboard

Vol #:

17

EMC 29

Marc Sklar

Vol #:

17

EMC 30

Aimee E. Raupp

Vol #:

17

EMC 31

Shelly A. Krahn

Vol #:

17

1997P-0441

Regulatory Status of Cholestin red yeast rice

WDL 1

Pharmanex, LLC

Vol #:

16

1998P-0610

Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC

C 51

Pfizer, Inc

Vol #:

5

EMC 92

Consumer Alert

Vol #:

5

2000P-1411

Set a regulatory limit for methylmercury in seafood

EMC 103

Catherine Tolson

Vol #:

2

2001P-0345

Listing the color additive yellow #5 for use in food/Drug

EMC 1181

Michel Cromwell

Vol #:

5

EMC 1182

Janet Barnhart

Vol #:

5

EMC 1183

John Dilday

Vol #:

5

EMC 1184

Ted Woods

Vol #:

5

EMC 1185

Madeleine Migenes

Vol #:

5

EMC 1186

Luanna Gault

Vol #:

5

LET 2

DHHS/PHS/FDA

Vol #:

3

2002D-0526

Guidance for drug Chemistry, Manufacturing, Control Info.

C 15

Generic Pharmaceutical Assn.

Vol #:

1

2002P-0292

Health Claims: Walnuts & Cornary Disease

ANS 1

HFS-800 to Covington & Burling on behalf of CA Walnut Commission

Vol #:

6

2002P-0505

Labeling nuts & eligible nut containing products reduce risk

ANS 1

HFS-800 to International Tree Nut Council

Vol #:

4

C 8

United States Senate

Vol #:

4

2003D-0112

Independent Consultants for Biotechnology Clinical Trials

C 1

Marlies Van Hoef, MD, Ph.D., MBA

Vol #:

1

2003D-0165

Current Good Manufacturing Practices for Medical Gases

C 1

Erie Medical

Vol #:

1

C 2

Life Corp.

Vol #:

1

C 3

SOS Technologies

Vol #:

1

2003D-0181

Pediatric Expertise for Advisory Panels; Guidance for Industry and FDA; Availability

EMC 1

Dr. Carl Patow

Vol #:

1

2003D-0186

Guidance for Industry: Use of Material From Deer and Elk In Animal Feed

C 5

National Renders Assn., Inc.

Vol #:

1

2003D-0195

Draft Guidance for Industry on Necessity of the Use of Food Product Categories in Registration of Food Facilities

GDL 1

Guidance

Vol #:

1

NAD 1

FDA

Vol #:

1

2003N-0168

July 31, 2003 Public Meeting on Consumer Medication Information

C 1

National Organization for Rare Disorders, Inc.

Vol #:

2

2003N-0169

Dental Amalgam; Request for Information

C 12

Ohio Dental Assn.

Vol #:

4

2003N-0285

Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability

BKG 1

BACKGROUND MATERIAL

Vol #:

1

2003P-0132

Part 135 FDA regulations standard of identity frozen dessert

C 3

Congress of the United States, House of Representatives

Vol #:

1