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Dockets Management


Volume 1-5

Volume 1
Cover Letter

Table of Contents and Bibliography

Tab A - Executive Summary
Tab A-I - Role of 100% Whey Protein Partially Hydrolyzed in infant formula & Reducing the Risk of Allergy in Healthy Infants

Tab B - Preliminary Requirements for Health Claim Petitions
Role of 100% Whey Protein Partially Hydrolyzed in infant formula meets all the preliminary requirements of 21 CFR 101.70

Tab C - Summary of Scientific Data
Definition of terms
The substance/disease relationship
Review and rating of the scientific evidence
Certification of ethical compliance
Review of selected clinical trials
Summary of meta-analyses, review papers and non-peer-reviewed reports

Tab D - Analytical Data - Substance Characterization
Technical attributes of the substance & of products eligible to make the proposed claim
Appendix D-I - 21 CFR 184.1979c - Whey Protein Concentrate
Appendix D-II - 21 CFR 184.1914 - Trypsin
Appendix D-III - TNBS Method for Alpha amino-Nitrogen/Total Nitrogen
Appendix D-IV - 1991 Directive of the Commission of European Communities on infant formulae and follow-on formulae
Appendix D-V - BLG ELISA Method
Appendix D-VI - Molecular Weight Graphs, continued
Appendix D-VII - Method for Peptide Profiling by SE-HPLC
Appendix D-VIII - Method for SDS-PAGE
Appendix D-IX - Method for Immunodiffusion
Appendix D-X - Preclinical Indicators Graphs, Figure I, Figure II, Figure III

Tab E - Model Qualified Health Claim
Proposed message
Consumer research
Expert opinions
Tab E-I - Expert Opinion Letters on Appropriateness of Message
Tab E-II - Curricula Vitae of the Experts

Tab F - Environmental Impact Assessment

Tab G - Certification of Completeness

Tab H - Reference List - Volume I: All Sections

Volume 2-3
Tab I - Copies of Listed References Published Material

Volumes 4-5
Tab J - Comprehensive Literature Search - Annotated Published Material

Tab K - Copies of Additional Articles Published Material

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Page last updated August 3, 2005 RSChorizonal rule
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