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| Dockets Entered
On October 21, 2003
Table of Contents
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| Docket #
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| Title
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| 1976N-0052G
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| OTC general comments & combinations
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| 1991P-0186
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| Pediatric Ingestion of Iron-Containing Drugs/Food Supplement
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| 1993P-0306
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| Warning Labels for Oral Preparations Containing Iron
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| 1997D-0411
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| (BSE) in Products for Human Use; Guidance for Industry.
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| 1997D-0443
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| Iron-Containing Supplements/Drugs :Label Warning Statements
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2000N-1484
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| Safety Reporting Requirements Human Drug/Biological Products
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| 2002P-0505
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| Labeling nuts & eligible nut containing products reduce risk
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| 2003D-0231
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| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format -- Postmarketing Periodic Adverse Drug Experience Reports; Availability
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| 2003D-0382
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| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
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| 2003D-0412
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| International Conference on Harmonisation; Draft Guidance on E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting
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| 2003F-0471
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| Filing of Food Additive Petition (FAP 3A4749)
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| 2003N-0016
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| MedWatch: The FDA Medical Products Reporting Program
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003N-0211
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| Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2003N-0463
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Formula Requirements
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| 2003N-0470
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| Preparation for ICH meetings and ICH 6 Conference in Osaka, Japan, November 9-15, 2003: Public Meeting
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| 2003P-0291
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| Enforce the law and prevent unlaw sale of contact lens
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| 2003P-0321
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| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
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| 2003P-0366
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| Amend approval for a nonprescription form of Prilosec (omeprazole magnesium)
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| 2003V-0423
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| Laser Light Show
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| 2003V-0428
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| Laser Light Show
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| 2003V-0484
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| Laser Light Show
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| 2003V-0485
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| Laser Light Show
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| 1976N-0052G
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| OTC general comments & combinations
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| MM
6
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| HFD-560 and Lil' Drug Store Products, Inc.
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| Vol #:
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| 150
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| 1991P-0186
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| Pediatric Ingestion of Iron-Containing Drugs/Food Supplement
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| NFR
2
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| FDA
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| Vol #:
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| 17
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| 1993P-0306
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| Warning Labels for Oral Preparations Containing Iron
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| NFR
2
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| FDA
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| Vol #:
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| 17
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| 1997D-0411
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| (BSE) in Products for Human Use; Guidance for Industry.
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| ACK 1
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| HFA-305 to the Gelatin Manufacturers of Europe and the Gelatin Manufacturers Institute of America
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| Vol #:
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| 1
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| CP
1
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| GME & GMIA
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| Vol #:
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| 2
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| 1997D-0443
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| Iron-Containing Supplements/Drugs :Label Warning Statements
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| GDL
1
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| GUIDANCE
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| Vol #:
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| 1
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| GDL
2
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| GUIDANCE
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| Vol #:
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| 1
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| NAD
2
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| FDA
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| Vol #:
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| 1
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
11293
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| Botanic Gardens, Inc.
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| Vol #:
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| 86
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| LET
11294
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| Botanical Laboratories
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| Vol #:
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| 86
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7097
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| Jannet L. Preti
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| Vol #:
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| 301
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| C 7098
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| Mr. and Mrs Edmond L. Preti
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| Vol #:
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| 301
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| C 7099
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| Fran Petty
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| Vol #:
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| 301
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| C 7100
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| Jami Tolpin
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| Vol #:
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| 301
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| 2000N-1484
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| Safety Reporting Requirements Human Drug/Biological Products
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| C
42
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| Orion Pharma, Inc.
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| Vol #:
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| 6
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| C
43
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| Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI)
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| Vol #:
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| 6
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| C
44
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| HarborView Medical Center
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| Vol #:
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| 6
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| C
45
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| Novo Nordisk Pharmaceuticals, Inc.
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| Vol #:
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| 6
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| C
46
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| American Academy of Orthopaedic Surgeons (AAOS/Academy)
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| Vol #:
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| 6
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| 2002P-0505
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| Labeling nuts & eligible nut containing products reduce risk
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| LET
11
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| Keller and Heckman, LLP
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| Vol #:
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| 4
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| 2003D-0231
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| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format -- Postmarketing Periodic Adverse Drug Experience Reports; Availability
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| NEC
1
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| FDA
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| Vol #:
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| 1
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| 2003D-0382
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| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
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| C
2
Attachment
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| International Consultants Assn
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| Vol #:
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| 1
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| 2003D-0412
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| International Conference on Harmonisation; Draft Guidance on E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting
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| C
1
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| Aventis Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| C
2
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| Merck & Co., Inc.
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| Vol #:
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| 1
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| C
3
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| Wyeth Research
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| Vol #:
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| 1
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| 2003F-0471
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| Filing of Food Additive Petition (FAP 3A4749)
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| NFL
1
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| FDA
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| Vol #:
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| 1
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| 2003N-0016
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| MedWatch: The FDA Medical Products Reporting Program
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| SS
1
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| SUPPORTING STATEMENT
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| Vol #:
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| 1
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| C
10
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| National Assn of MArgarine Manufacturers (NAMM)
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| Vol #:
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| 3
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| C
11
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| American Dietetic Assn (ADA)
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| Vol #:
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| 3
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| C
12
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| General Mills
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| Vol #:
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| 3
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| 2003N-0211
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| Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma
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| C
1
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| Davis County Hospital
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| Vol #:
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| 1
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| C
2
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| Fort Madison Community Hospital
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| Vol #:
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| 1
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| C
3
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| Monroe County Hospital
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| Vol #:
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| 1
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| C
4
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| Alpha Therapeutic Corporation
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| Vol #:
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| 1
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| C
1
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| Center for Science in the Public Interest (CSPI)
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| Vol #:
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| 1
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| 2003N-0463
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Formula Requirements
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2003N-0470
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| Preparation for ICH meetings and ICH 6 Conference in Osaka, Japan, November 9-15, 2003: Public Meeting
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| NM
1
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| FDA
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| Vol #:
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| 1
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| C
1
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| Hyman, Phelps & McNamara, PC
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| Vol #:
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| 3
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| 2003P-0291
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| Enforce the law and prevent unlaw sale of contact lens
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| C 59
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| Thomas C. Kirchgessner, O.D.
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| Vol #:
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| 2
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| 2003P-0321
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| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
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| C
7
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| Geneva Pharmaceuticals, Inc. (Geneva)
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| Vol #:
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| 2
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| 2003P-0366
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| Amend approval for a nonprescription form of Prilosec (omeprazole magnesium)
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| LET
1
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| Mylan Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2003V-0423
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| Laser Light Show
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| VRA
1
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| HFZ-300 to Avampato Discovery Museum
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| Vol #:
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| 1
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| 2003V-0428
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| Laser Light Show
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