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| Dockets Entered
On August 3, 2005
Table of Contents
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| Docket #
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| Title
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| 1976N-0052N
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| OTC Nasal Decongestants
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| 1995N-0205
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| OTC Bronchodilator Drug Products
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| 1997N-0484T
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| Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| 2004N-0279
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| Developing DIA/FDA Workshop: Pharmacogenomic Combination Product Co-development; Public Meeting
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| 2005D-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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| 2005D-0155
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| Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
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| 2005D-0202
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| Guidance for Industry on Bar Code Label Requirements; Questions and Answers
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| 2005D-0203
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| Guidance for Industry on Safety Testing of Drug Metabolites
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| 2005N-0178
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Under the Federal Import Milk Act
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| 2005P-0224
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| To request administrative action regarding the purported weight and fat loss benefits of dairy products
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| 2005P-0307
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| ANDA Suitability for Warfarin Sodium Solution
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| 2005Q-0297
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| Qualified Health Claim (QHC): Green Tea and Reduced Risk of Cardiovascular Disease
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| 2005V-0268
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| Projector for a Laser Light Show
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| 1976N-0052N
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| OTC Nasal Decongestants
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| C
243
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| Bayer HealthCare, Consumer Care Division
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| Vol #:
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| 77
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| 1995N-0205
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| OTC Bronchodilator Drug Products
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| EC 1
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| Dr. Thomas Tiedt
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| Vol #:
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| 7
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| 1997N-0484T
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| Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling
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| EC
1
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| Fertility Alternatives, Inc
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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
16452
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| Purapharm International (H.K.) Limited
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| Vol #:
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| 147
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| LET
16453
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| Enzymatic Therapy
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| Vol #:
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| 147
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| LET
16454
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| Enzymatic Therapy
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| Vol #:
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| 147
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| LET
16455
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| Enzymatic Therapy
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| Vol #:
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| 147
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| LET
16456
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| Enzymatic Therapy
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| Vol #:
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| 147
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| LET
16457
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| Enzymatic Therapy
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| Vol #:
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| 147
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| LET
16458
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| Michael's Naturopathic Programs
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| Vol #:
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| 147
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| LET
16459
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| AdvoCre International, L.P.
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| Vol #:
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| 147
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| LET
16460
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| AdvoCare International, L.P.
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| Vol #:
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| 147
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| LET
16461
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| Sigma-Tau Pharmaceuticals, Inc.
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| Vol #:
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| 147
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| LET
16462
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| Enzymatic Therapy
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| Vol #:
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| 147
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| LET
16463
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| Enzymatic Therapy
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| Vol #:
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| 147
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| LET
16464
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| Miracle Breakthrough Lab, Inc.
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| Vol #:
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| 147
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| LET
16465
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| Miracle Breakthrough Lab, Inc.
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| Vol #:
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| 147
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| LET
16466
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| Miracle Breakthrough Lab, Inc.
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| Vol #:
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| 147
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| LET
16467
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| Leiner Health Products
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| Vol #:
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| 147
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| LET
16468
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| Enzymatic Therapy
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| Vol #:
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| 147
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| LET
16469
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| Enzymatic Therapy
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| Vol #:
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| 147
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| LET
16470
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| Enzymatic Therapy
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| Vol #:
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| 147
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| LET
16471
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| Enzymatic Therapy
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| Vol #:
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| 147
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| LET
16472
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| Enzymatic Therapy
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| Vol #:
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| 147
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| LET
16473
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| Enzymatic Therapy
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| Vol #:
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| 147
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| LET
16474
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| Douglas Laboratories
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| Vol #:
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| 147
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| EMC
1431
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| Rohwer Technical Consulting LLC
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| Vol #:
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| 23
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| 2004N-0279
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| Developing DIA/FDA Workshop: Pharmacogenomic Combination Product Co-development; Public Meeting
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| EC
4
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| Johnson & Johnson
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| Vol #:
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| 1
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| 2005D-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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| C
4
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| Society for Women's Health Research
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| Vol #:
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| 1
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| C
5
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| AstraZeneca LP
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| Vol #:
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| 1
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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| C
15
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| Washington University In St. Louis, School of Medicine
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| Vol #:
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| 1
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| 2005D-0155
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| Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
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| C
4
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| GlaxoSmithKline
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| Vol #:
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| 1
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| C
5
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| HIV Vaccine Trials Network
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| Vol #:
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| 1
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| 2005D-0202
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| Guidance for Industry on Bar Code Label Requirements; Questions and Answers
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| C
1
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| Pfizer Inc
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| Vol #:
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| 1
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| 2005D-0203
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| Guidance for Industry on Safety Testing of Drug Metabolites
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| C
1
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| Boehringer Ingelheim Pharmaceuticals Inc
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| Vol #:
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| 1
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| C
2
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| Eli Lilly and Company
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| Vol #:
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| 1
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| C
3
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| Sanofi-Synthelabo Inc, Aventis Pharmaceuticals
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| Vol #:
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| 1
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| 2005N-0178
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Under the Federal Import Milk Act
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| EC 1
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| National Milk Producers Federation
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| Vol #:
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| 1
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| EC
2
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| National Milk Producers Federation
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| Vol #:
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| 1
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| EC
11
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| Mr. C.R. Schmink
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| Vol #:
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| 1
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| EC
12
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| Mrs. Starr McGettigan
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| Vol #:
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| 1
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| EC
13
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| My Family
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| Vol #:
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| 1
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| EC
14
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| Mr. Tom George
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| Vol #:
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| 1
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| LET
1
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| HFZ-1 to RS Medical
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| Vol #:
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| 3
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| 2005P-0224
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| To request administrative action regarding the purported weight and fat loss benefits of dairy products
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| WDL
1
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| Physicians Committee for Responible Medicine
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| Vol #:
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| 2
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| 2005P-0307
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| ANDA Suitability for Warfarin Sodium Solution
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| ACK
1
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| HFA-305 to Morton Grove Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| CP
1
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| Morton Grove Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2005Q-0297
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| Qualified Health Claim (QHC): Green Tea and Reduced Risk of Cardiovascular Disease
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| LET
1
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| HFS-800 to AAC Consulting Group
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| Vol #:
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| 5
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| 2005V-0268
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| Projector for a Laser Light Show
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| VRA
1
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| HFZ-200 to Alchemy Concert Systems Inc
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| Vol #:
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| 1
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