Dockets Entered On September 8, 2003

Table of Contents

Docket #

Title

1977N-0094I 1          Internal, Analgesic, Antipyretic, and Antirheumatic Drug Pro. 1

1978N-0021. 1           Skin Protectant Drugs for OTC Human Use. 1

1978N-0021P. 1         Skin Protectant Drug Products for OTC Human Use. 1

1993P-0174. 1           Amend Regs for Liquid Medicated Animal Feed. 1

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

2002P-0292. 2           Health Claims: Walnuts & Coronary Disease. 2

2003D-0165. 2           Current Good Manufacturing Practices for Medical Gases. 2

2003D-0420. 2           Class II Special Controls Guidance Document: Pressure Regulators for Use with Medical Oxygen  2

2003N-0076. 2           Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements  2

1977N-0094I

Internal, Analgesic, Antipyretic, and Antirheumatic Drug Pro

C 3

McNeil Consumer & Specialty Pharmaceuticals (McNeil)

Vol #:

6

C 4

McNeil Consumer & Specialty Pharmaceuticals (McNeil)

Vol #:

7

1978N-0021

Skin Protectant Drugs for OTC Human Use

C 67

The Mentholatum Co., Inc.

Vol #:

43

C 68

Hyman, Phelps & McNamara, P.C.

Vol #:

43

C 69

Cosmetic, Toiletry, and Fragrance Assn (CTFA)

Vol #:

43

1978N-0021P

Skin Protectant Drug Products for OTC Human Use

C 3

The Mentholatum Co., Inc.

Vol #:

1

C 4

Hyman, Phelps & McNamara, PC (HPM)

Vol #:

1

C 5

Cosmetic, Toiletry, and Fragrance Assn (CTFA)

Vol #:

1

1993P-0174

Amend Regs for Liquid Medicated Animal Feed

C 3

Land O'Lakes Feed

Vol #:

1

1997S-0162

30-Day Structure Function Claim Notification Letters Dietary

LET 10750

NBTY, Inc.

Vol #:

81

LET 10751

NBTY, Inc.

Vol #:

81

LET 10752

NBTY, Inc.

Vol #:

81

LET 10753

NBTY, Inc.

Vol #:

81

LET 10754

NBTY, Inc.

Vol #:

81

LET 10755

NBTY, Inc.

Vol #:

81

LET 10756

NBTY, Inc.

Vol #:

81

LET 10757

NBTY, Inc.

Vol #:

81

LET 10758

NBTY, Inc.

Vol #:

81

LET 10759

NBTY, Inc.

Vol #:

81

LET 10760

NBTY, Inc.

Vol #:

81

LET 10761

NBTY, Inc.

Vol #:

81

LET 10762

NBTY, Inc.

Vol #:

81

LET 10763

NBTY, Inc.

Vol #:

81

LET 10764

Enzymatic Therapy Natural Medicines

Vol #:

81

LET 10765

Enzymatic Therapy Natural Medicines

Vol #:

81

LET 10766

Enzymatic Therapy Natural Medicines

Vol #:

81

LET 10767

PhytoPharmica Natural Medicines

Vol #:

81

LET 10768

Integrative Therapeutics Inc.

Vol #:

81

LET 10769

Integrative Therapeutics Inc.

Vol #:

81

LET 10770

PhytoPharmica Natural Medicines

Vol #:

81

LET 10771

PhytoPharmica Natural Medicines

Vol #:

81

LET 10772

PhytoPharmica Natural Medicines

Vol #:

81

LET 10773

PhytoPharmica Natural Medicines

Vol #:

81

LET 10774

Enzymatic Therapy Natural Medicines

Vol #:

81

LET 10775

Enzymatic Therapy Natural Medicines

Vol #:

81

LET 10776

PhytoPharmica Natural Medicines

Vol #:

81

LET 10777

Twin laboratories, Inc.

Vol #:

81

LET 10778

Twin Laboratories, Inc.

Vol #:

81

LET 10779

Twin Laboratories, Inc.

Vol #:

81

LET 10780

NBTY, Inc.

Vol #:

81

LET 10781

NBTY, Inc.

Vol #:

81

LET 10782

NBTY, Inc.

Vol #:

81

LET 10783

NBTY, Inc.

Vol #:

81

LET 10784

NBTY, Inc.

Vol #:

81

LET 10785

NBTY, Inc.

Vol #:

81

LET 10786

NBTY, Inc.

Vol #:

82

LET 10787

NBTY, Inc.

Vol #:

82

LET 10788

NBTY, Inc.

Vol #:

82

LET 10789

NBTY, Inc.

Vol #:

82

LET 10790

NBTY, Inc.

Vol #:

82

LET 10791

NBTY, Inc.

Vol #:

82

LET 10792

NBTY, Inc.

Vol #:

82

LET 10793

NBTY, Inc.

Vol #:

82

LET 10794

NBTY, Inc.

Vol #:

82

LET 10795

NBTY, Inc.

Vol #:

82

LET 10796

NBTY, Inc.

Vol #:

82

LET 10797

NBTY, Inc.

Vol #:

82

LET 10798

NBTY, Inc.

Vol #:

82

LET 10799

NBTY, Inc.

Vol #:

82

LET 10800

NBTY, Inc.

Vol #:

82

LET 10801

NBTY, Inc.

Vol #:

82

LET 10802

NBTY, Inc.

Vol #:

82

LET 10803

NBTY, Inc.

Vol #:

83

LET 10804

NBTY, Inc.

Vol #:

82

LET 10805

NBTY, Inc.

Vol #:

82

LET 10806

NBTY, Inc.

Vol #:

82

LET 10807

NBTY, Inc.

Vol #:

82

LET 10808

NBTY, Inc.

Vol #:

82

LET 10809

NBTY, Inc.

Vol #:

82

LET 10810

NBTY, Inc.

Vol #:

82

LET 10811

NBTY, Inc.

Vol #:

82

LET 10812

NBTY, Inc.

Vol #:

82

LET 10813

NBTY, Inc.

Vol #:

82

LET 10814

NBTY, Inc.

Vol #:

82

LET 10815

NBTY, Inc.

Vol #:

82

LET 10816

NBTY, Inc.

Vol #:

82

LET 10817

NBTY, Inc.

Vol #:

82

LET 10818

NBTY, Inc.

Vol #:

82

LET 10819

NBTY, Inc.

Vol #:

82

LET 10820

NBTY, Inc.

Vol #:

82

LET 10821

NBTY, Inc.

Vol #:

82

LET 10822

NBTY, Inc.

Vol #:

82

LET 10823

NBTY, Inc.

Vol #:

82

LET 10824

NBTY, Inc.

Vol #:

82

LET 10825

NBTY, Inc.

Vol #:

82

LET 10826

NBTY, Inc.

Vol #:

82

LET 10827

NBTY, Inc.

Vol #:

82

LET 10828

NBTY, Inc.

Vol #:

82

LET 10829

NBTY, Inc.

Vol #:

82

2002P-0292

Health Claims: Walnuts & Coronary Disease

C 19

Scott M. Grundy, M.D., PhD

Vol #:

6

C 20

Scott M. Grundy, M.D., PhD

Vol #:

6

C 21

Tufts University

Vol #:

6

C 22            Attachment

Oregon Hazelnuts

Vol #:

6

C 23          Attachment

Blue Diamond Growers

Vol #:

6

C 24          Attachment

International Tree Nut Council Nutrition Research and Education Foundation (INC-NREF)

Vol #:

6

C 25          Attachment

California Pistachio Commission

Vol #:

6

C 26         Attachment

National Pecan Shellers Assn (NPSA)

Vol #:

6

LET 2

California Walnut Commission

Vol #:

6

LET 3

HFS-800 to Covington & Burling

Vol #:

6

LET 4

HFS-800 to Covington & Burling

Vol #:

6

LET 5

California Walnut Commission

Vol #:

6

RPT 1

William R. Harlan, MD

Vol #:

6

RPT 2

Tufts University

Vol #:

6

RPT 3

William R. Harlan, M.D.

Vol #:

6

2003D-0165

Current Good Manufacturing Practices for Medical Gases

C 10

Respond Systems of Montana

Vol #:

1

C 11

SOS Technologies

Vol #:

1

C 12

Affirmed Medical Services

Vol #:

1

C 13

Commercial First Aid and Safety

Vol #:

1

C 14

Divers Alert Network

Vol #:

1

C 15

Farmington Fire Equipment and Safety

Vol #:

1

C 16

FDA, Seattle

Vol #:

1

C 17

Alpine Fire and Safety Systems, Inc

Vol #:

1

2003D-0420

Class II Special Controls Guidance Document: Pressure Regulators for Use with Medical Oxygen

C 1         Attachment

Allied Healthcare Products Inc

Vol #:

2

2003N-0076

Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements

EXT 1

National Food Processors Association

Vol #:

1

2003N-0361

Anti-Counterfeit Drug Initiative

APE 1

ITW HoloPak

Vol #:

1

APE 2

Lewis T Kontnik

Vol #:

1

APE 3

Molecular Isotope Technologies LLC

Vol #:

1

APE 4

Uniform Code Council

Vol #:

1